UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
 
þ
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
 
 
For the Fiscal Year Ended December 31, 2015
 or
¨
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
 
 
For the Transition Period from _____________ to _____________
Commission File Number:  000-30111
Lexicon Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in its Charter)
 
Delaware
 
76-0474169
 
 
(State or Other Jurisdiction of Incorporation or Organization)
 
(I.R.S. Employer Identification Number)
 
 
8800 Technology Forest Place
The Woodlands, Texas 77381
(Address of Principal Executive Offices and Zip Code)
 
(281) 863-3000
(Registrant’s Telephone Number,
Including Area Code)
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of Each Class
 
Name of Each Exchange on which Registered
 
 
 Common Stock, par value $0.001 per share
 
 Nasdaq Global Select Market
 
Securities registered pursuant to Section 12(g) of the Act:  None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act of 1933.  Yes o  No þ
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934.   Yes o  No þ
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.   Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).   Yes þ No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company.  See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Securities Exchange Act of 1934.  (check one):  Large accelerated filer o   Accelerated filer  þ Non-accelerated filer o   Smaller reporting company o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934).   Yes o No þ
The aggregate market value of voting stock held by non-affiliates of the registrant as of the last day of the registrant’s most recently completed second quarter was approximately $335.0 million, based on the closing price of the common stock on the Nasdaq Global Select Market on June 30, 2015 of $8.05 per share.  For purposes of the preceding sentence only, our directors, executive officers and controlling stockholders are assumed to be affiliates.  As of March 7, 2016, 103,769,656 shares of common stock were outstanding.
Documents Incorporated by Reference
Certain sections of the registrant’s definitive proxy statement relating to the registrant’s 2016 annual meeting of stockholders, which proxy statement will be filed under the Securities Exchange Act of 1934 within 120 days of the end of the registrant’s fiscal year ended December 31, 2015, are incorporated by reference into Part III of this annual report on Form 10-K.
 
 
 
 
 
 
 
 
 
 



Table of Contents

Lexicon Pharmaceuticals, Inc.
Table of Contents

Item
 
 
PART I
1.
1A.
1B.
2.
3.
4.
PART II
5.
6.
7.
7A.
8.
9.
9A.
9B.
PART III
10.
11.
12.
13.
14.
PART IV
15.
 
 
 
 
The Lexicon name and logo are registered trademarks and Genome5000 is a trademark of Lexicon Pharmaceuticals, Inc.
_____________________________________________________

In this annual report on Form 10-K, “Lexicon Pharmaceuticals,” “Lexicon,” “we,” “us” and “our” refer to Lexicon Pharmaceuticals, Inc. and its subsidiaries.
_____________________________________________________

This annual report on Form 10-K contains forward-looking statements.  These statements relate to future events or our future financial performance.  We have attempted to identify forward-looking statements by terminology including “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “should” or “will” or the negative of these terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks outlined under “Item 1A.  Risk Factors,” that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. We are not under any duty to update any of the forward-looking statements after the date of this annual report on Form 10-K to conform these statements to actual results, unless required by law.


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PART I
 
Item 1. Business
 
Overview
 
Lexicon Pharmaceuticals is a biopharmaceutical company focused on the development of breakthrough treatments for human disease.  We have advanced multiple drug candidates into clinical development and are presently devoting most of our resources to the development of our two most advanced drug candidates:

We are developing telotristat etiprate, or LX1032, an orally-delivered small molecule drug candidate, as a treatment for carcinoid syndrome. We have reported positive top-line data from both our pivotal TELESTAR Phase 3 clinical trial and its companion TELECAST Phase 3 clinical trial of telotristat etiprate in carcinoid syndrome patients. We are presently preparing an application for regulatory approval to market telotristat etiprate in the United States and, if approved, for the commercial launch of telotristat etiprate in the United States. We have granted Ipsen Pharma SAS an exclusive, royalty-bearing right to commercialize telotristat etiprate outside of the United States and Japan.
We are developing sotagliflozin, or LX4211, an orally-delivered small molecule drug candidate, as a treatment for type 1 and type 2 diabetes. We have reported positive data from a Phase 2 clinical trial of sotagliflozin in type 1 diabetes patients and two additional Phase 2 clinical trials of sotagliflozin in type 2 diabetes patients. We have granted Sanofi an exclusive, worldwide, royalty-bearing right to develop, manufacture and commercialize sotagliflozin. We are presently conducting Phase 3 development of sotagliflozin for type 1 diabetes and preparing with Sanofi for Phase 3 development of sotagliflozin in type 2 diabetes.
Our most advanced drug candidates, as well as compounds from a number of additional drug discovery and development programs that we have advanced into various stages of clinical and preclinical development, originated from our own internal drug discovery efforts. These efforts were driven by a systematic, target biology-driven approach in which we used gene knockout technologies and an integrated platform of advanced medical technologies to systematically study the physiological and behavioral functions of almost 5,000 genes in mice and assessed the utility of the proteins encoded by the corresponding human genes as potential drug targets. We have identified and validated in living animals, or in vivo, more than 100 targets with promising profiles for drug discovery.

We are working both independently and through strategic collaborations and alliances with third parties to capitalize on our drug target discoveries and drug discovery and development programs. We seek to retain exclusive or co-exclusive rights to the benefits of certain drug discovery and development programs by developing and commercializing drug candidates from those programs internally, particularly in the United States for indications treated by specialist physicians. We seek to collaborate with other pharmaceutical and biotechnology companies, such as Ipsen, Sanofi and Bristol-Myers Squibb, with respect to drug discovery or the development and commercialization of certain of our drug candidates, particularly with respect to commercialization in territories outside the United States, commercialization in the United States for indications treated by primary care physicians, or when the collaboration may otherwise provide us with access to expertise and resources that we do not possess internally or are complementary to our own.
 
Lexicon Pharmaceuticals was incorporated in Delaware in July 1995, and commenced operations in September 1995.  Our corporate headquarters are located at 8800 Technology Forest Place, The Woodlands, Texas 77381, and our telephone number is (281) 863-3000.
 
Our annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 are made available free of charge on our corporate website located at www.lexpharma.com as soon as reasonably practicable after the filing of those reports with the Securities and Exchange Commission.  Information found on our website should not be considered part of this annual report on Form 10-K.

Our Drug Programs
 
We have advanced multiple drug candidates into clinical development. We are presently devoting most of our resources to the development of our two most advanced drug candidates, telotristat etiprate for carcinoid syndrome and sotagliflozin for type 1 and type 2 diabetes. We have also advanced a number of additional compounds into various stages of clinical and preclinical development.


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Telotristat etiprate (LX1032)
 
Telotristat etiprate, or LX1032, is an orally-delivered small molecule compound that we are developing for the treatment of carcinoid syndrome. Telotristat etiprate was internally generated by our medicinal chemists and inhibits tryptophan hydroxylase, or TPH, the rate-limiting enzyme for serotonin production found primarily in enterochromaffin, or EC, cells of the gastrointestinal tract. Our scientists found that mice lacking the non-neuronal form of this enzyme, TPH1, have virtually no serotonin in the gastrointestinal tract, but maintain normal levels of serotonin in the brain. Telotristat etiprate was specifically designed to achieve systemic exposure to address disorders such as carcinoid syndrome that require regulation of serotonin levels beyond the EC cells in the gastrointestinal tract without impacting brain serotonin production.

We reported top-line data in August 2015 from our pivotal TELESTAR Phase 3 clinical trial of telotristat etiprate evaluating the safety and tolerability of telotristat etiprate and its activity in carcinoid syndrome. The trial enrolled 135 patients with inadequately controlled carcinoid syndrome on background somatostatin analog therapy, the current standard of care, in a randomized, double-blind, placebo-controlled study of 250mg three times daily and 500mg three times daily doses of telotristat etiprate over a 12-week treatment period, followed by a 36-week, open-label extension where all patients receive 500mg three times daily doses of telotristat etiprate. The primary efficacy endpoint under evaluation in the trial was the number of daily bowel movements, with secondary efficacy endpoints including changes in urinary 5-HIAA, the primary metabolite of serotonin and a biomarker for serotonin synthesis, flushing episodes, abdominal pain and quality of life measures. Top-line data from the study showed that patients who added telotristat etiprate to the standard of care at both the 250mg and 500mg doses experienced a statistically significant reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period, meeting the study’s primary endpoint. A substantially greater proportion of patients on telotristat etiprate achieved a durable response (44 percent and 42 percent in the 250mg and 500mg treatment arms, respectively), defined as at least a 30 percent reduction in daily bowel movements over at least half the days of the study period, as compared to 20 percent response on placebo (p<0.040). Patients who received 250mg of telotristat etiprate experienced a 29 percent reduction in the average number of daily bowel movements during the final week (week 12) of the study period compared to baseline, and those in the 500mg arm experienced a 35 percent reduction, while the placebo group showed a 17 percent reduction. The proportion of patients with treatment-emergent adverse events, serious adverse events and discontinuation due to adverse events were generally similar in all three treatment arms. The tolerability profile of the 250mg dose appeared similar to placebo and somewhat better than the 500mg dose with respect to gastrointestinal discomfort and mood. The overall incidence and nature of adverse events in TELESTAR were consistent with those reported in previous studies.

We reported top-line data in November 2015 from our additional TELECAST Phase 3 clinical trial of telotristat etiprate, which was designed as a companion to our pivotal TELESTAR Phase 3 clinical trial to provide additional safety exposure while further evaluating telotristat etiprate’s activity in carcinoid syndrome. The trial enrolled 76 patients in a randomized, double-blind, placebo-controlled study of 250mg three times daily and 500mg three times daily doses of telotristat etiprate over a 12-week treatment period. Patients qualified for the trial based on at least one symptom of carcinoid syndrome, such as at least two episodes of flushing per day, elevated urinary 5-HIAA at baseline or nausea present on at least one out of five days at baseline. Most enrolled patients were on background somatostatin analog therapy. Patients who were not on background somatostatin analog therapy could also qualify for the trial based on experiencing at least four bowel movements per day as their symptom of carcinoid syndrome. The primary efficacy endpoint under evaluation in the trial was the change in urinary 5-HIAA, with secondary endpoints including the number of daily bowel movements. Top-line data from the study showed that patients treated with telotristat etiprate at both the 250mg and 500mg doses experienced a statistically significant reduction from baseline compared to placebo in urinary 5-HIAA at week 12, (p<0.001), meeting the study’s primary efficacy endpoint. Patients treated with telotristat etiprate at both the 250mg and 500mg doses also experienced a statistically significant percent reduction from baseline compared to placebo in the average number of daily bowel movements over the 12-week study period (p=0.004 and p<0.001 for the 250mg and 500mg arms, respectively). The proportion of patients with treatment-emergent adverse events, serious adverse events and discontinuation due to adverse events were generally similar in all three treatment arms, with patients receiving telotristat etiprate experiencing a slightly higher rate of treatment-emergent adverse events. In general, the tolerability profile of both doses of telotristat etiprate appeared similar to placebo and the overall incidence and nature of adverse events in TELECAST were consistent with those reported in previous studies.

We previously completed two Phase 2 clinical trials in carcinoid syndrome patients, in which telotristat etiprate provided evidence of efficacy across multiple endpoints, including bowel movement frequency, stool consistency and decreased levels of urinary 5-HIAA. Telotristat etiprate was well tolerated in the studies, with no dose-limiting toxicity observed.

We are presently preparing an application for regulatory approval to market telotristat etiprate in the United States and, if approved, for the commercial launch of telotristat etiprate in the United States. We have entered into a license and

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collaboration agreement with Ipsen Pharma SAS under which we granted Ipsen an exclusive, royalty-bearing right and license to commercialize telotristat etiprate outside of the United States and Japan.

Telotristat etiprate has received Fast Track status and Orphan Drug designation from the United States Food and Drug Administration, or FDA, for the treatment of gastrointestinal symptoms associated with carcinoid syndrome in patients who no longer respond to the standard care. Telotristat etiprate has also received Orphan Drug designation from the Committee for Orphan Medical Products of the European Medicines Agency for the treatment of carcinoid tumors.

Sotagliflozin (LX4211)
 
Sotagliflozin, or LX4211, is an orally-delivered small molecule compound that we are developing for the treatment of type 1 and type 2 diabetes mellitus. Sotagliflozin was internally generated by our medicinal chemists and inhibits both sodium-glucose cotransporter type 2, or SGLT2, a transporter responsible for most of the glucose reabsorption performed by the kidney, and sodium-glucose cotransporter type 1, or SGLT1, a transporter responsible for glucose and galactose absorption in the gastrointestinal tract. Our scientists identified mice lacking SGLT1, SGLT2 or both as having potent anti-diabetic phenotypes across multiple measures of glucose control and metabolism, and found that compounds inhibiting both targets had a favorable preclinical profile relative to compounds selective for SGLT2.

Type 1 Diabetes.

We are conducting two pivotal Phase 3 clinical trials evaluating the safety and tolerability of sotagliflozin and its effects on glycemic parameters associated with type 1 diabetes. Each of the pivotal Phase 3 trials are expected to enroll approximately 750 patients with type 1 diabetes in randomized, double-blind, placebo-controlled studies of 200mg and 400mg once daily doses of sotagliflozin over 24-week treatment periods, followed by 28-week extensions. The primary efficacy endpoint under evaluation in both pivotal Phase 3 trials is the reduction of hemoglobin A1c, or A1C, versus placebo on optimized insulin treatment at 24 weeks, with secondary endpoints including percentage of patients achieving A1C levels of less than 7%, reduction in meal-time, or bolus, insulin use and weight loss. We are also conducting a third Phase 3 clinical trial of sotagliflozin, which is expected to enroll approximately 1,400 patients with type 1 diabetes in a randomized, double-blind, placebo-controlled study of a 400mg once daily dose of sotagliflozin over a 24-week treatment period. The primary efficacy endpoint under evaluation in the third Phase 3 trial is the proportion of patients on optimized insulin treatment achieving A1C levels of less than 7% at 24 weeks, with secondary endpoints including the reduction of A1C, weight loss and systolic blood pressure levels. We are also concurrently conducting a Phase 2 clinical trial of sotagliflozin in a younger adult type 1 diabetes population in collaboration with JDRF and a dose-ranging study of sotagliflozin in patients with type 1 diabetes.

We previously completed a Phase 2 clinical trial evaluating the safety and tolerability of sotagliflozin and its effects on glycemic parameters associated with type 1 diabetes. The Phase 2 trial enrolled 36 patients with type 1 diabetes. An initial cohort consisted of three patients treated with a 400 mg once daily dose of sotagliflozin for a period of four weeks. A subsequent cohort of 33 patients were enrolled in the randomized, double-blind, placebo-controlled portion of the study and were treated with a 400mg once daily dose of sotagliflozin or placebo for a period of four weeks. The primary efficacy endpoint under evaluation in the trial was reduction in bolus insulin use. Secondary endpoints included multiple parameters of glycemic control, basal and total insulin use and other metabolic, pharmacodynamic and pharmacokinetic parameters. Data from the study showed that treatment with sotagliflozin demonstrated statistically significant benefits in the primary and multiple secondary endpoints. Patients treated with sotagliflozin experienced a reduction in their total daily mealtime bolus insulin dose of 32% compared to 6% for patients who received placebo (p=0.007). We also observed a significant improvement in glycemic control, with a mean A1C reduction of 0.55% in the sotagliflozin-treated group compared to a reduction of 0.06% in the placebo-treated group (p=0.002). These observations were also accompanied by significant improvement in the time spent in a glucose range of 70-180 mg/dl, a significant reduction in time in hyperglycemic range (>180 mg/dl) and no increase in time in hypoglycemic range (<70mg/dl). Multiple measures also indicated that patients treated with sotagliflozin experienced reduced variability in blood glucose levels. Sotagliflozin was well tolerated with no discontinuations of study medication due to adverse events.


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Type 2 Diabetes.

We and Sanofi are presently preparing for the initiation of Phase 3 development of sotagliflozin in type 2 diabetes patients. We previously completed two Phase 2 clinical trials evaluating the safety and tolerability of sotagliflozin and its effects on glycemic parameters associated with type 2 diabetes.

The Phase 2b clinical trial enrolled 299 patients with type 2 diabetes who were not adequately controlled on metformin monotherapy in a double-blind, randomized, placebo-controlled study of 75mg once daily, 200mg once daily, 200mg twice daily and 400mg once daily doses of sotagliflozin, each administered in combination with standard metformin therapy over a 12‑week treatment period. The primary efficacy endpoint under evaluation in the trial was the change in A1C from baseline to week 12. Secondary efficacy endpoints included percentage of patients achieving A1C levels of less than 7%, as well as changes in fasting plasma glucose levels, weight, blood pressure and triglyceride levels. Data from the study showed that treatment with sotagliflozin demonstrated statistically significant benefits in the primary and multiple secondary endpoints. Patients in each of the 75mg once daily, 200mg once daily, 200mg twice daily and 400mg once daily sotagliflozin treatment arms had mean A1C reductions from baseline of 0.43, 0.52, 0.79 and 0.92 percent, respectively (p<0.001 for all treatment arms), while in patients randomized to placebo, A1C decreased by 0.09 percent. We also observed that patients treated with sotagliflozin showed significant reductions in body weight and blood pressure. Sotagliflozin was well tolerated and adverse events were generally mild to moderate, with the overall incidence of adverse events with sotagliflozin being similar to placebo.

The Phase 2a clinical trial enrolled 36 patients with non-insulin dependent type 2 diabetes in a double-blind, randomized, placebo-controlled study of 150mg and 300mg doses of sotagliflozin, each administered once daily over a four-week treatment period. The efficacy endpoints under evaluation in the trial included urinary glucose excretion, fasting plasma glucose, response to oral glucose tolerance testing, and change in A1C. Data from the study showed that treatment with 150mg and 300mg of sotagliflozin provided improvements in glycemic control and demonstrated statistically significant benefits in the primary and multiple secondary efficacy endpoints. A marked and statistically significant decrease in fasting plasma glucose was observed at each measurement point throughout the treatment period in both treatment arms relative to placebo. After four weeks of dosing, patients in both dose groups exhibited statistically significant reductions in A1C as compared to patients receiving placebo (p=0.001 and p<0.001 for the 150mg and 300mg treatment arms, respectively). Patients in both treatment arms also exhibited statistically significant improvements in glucose tolerance in response to oral glucose tolerance testing (p<0.001 for both treatment arms). Consistent with the mechanism of action of sotgliflozin, there was also a significant, dose-dependent increase in 24-hour urinary glucose excretion in both treatment arms at each measurement point throughout the study period relative to placebo (p<0.001 at all time points measured). Patients in both treatment arms also showed positive trends in broader metabolic and cardiovascular parameters, including weight reduction, decreased blood pressure and lower triglyceride levels. Sotagliflozin was well tolerated in the trial, with no dose-limiting toxicities observed and adverse events being generally mild and equally distributed across all treatment groups, including the placebo group.

In addition, we previously completed a clinical trial evaluating the safety and tolerability of sotagliflozin and its effects on glycemic parameters associated with type 2 diabetes in patients with moderate renal impairment. The clinical trial enrolled 30 patients with type 2 diabetes and moderate to severe renal impairment in a randomized, double-blind, placebo-controlled study of a 400mg once daily dose of sotagliflozin over a seven-day treatment period. The primary efficacy endpoint under evaluation in the trial was the change in postprandial glucose from baseline to day seven, with secondary endpoints including a variety of glycemic control parameters. Data from the study showed that treatment with sotagliflozin provided clinically meaningful and statistically significant reductions (p<0.05) in post-prandial glucose and produced significant elevations in GLP-1, a hormone involved in control of glucose and appetite. Sotagliflozin was well tolerated and adverse events were generally mild to moderate, with the overall incidence of adverse events with sotagliflozin being similar to placebo.

We have entered into a collaboration and license agreement with Sanofi under which we granted Sanofi an exclusive, worldwide, royalty-bearing right and license to develop, manufacture and commercialize sotagliflozin.

Other Development Programs
 
LX2761. LX2761 is an orally-delivered small molecule compound for the treatment of diabetes. LX2761 was internally generated by our medicinal chemists and is designed to inhibit SGLT1 locally in the gastrointestinal tract without any significant inhibition of SGLT2 in the kidney. We have completed IND-enabling studies of LX2761 and are presently preparing to submit an IND and commence clinical development. We have granted Sanofi certain rights of first negotiation with respect to the future development and commercialization of LX2761.


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LX9211. LX9211 is an orally-delivered small molecule compound for the treatment of neuropathic pain. LX9211 is included in our drug discovery alliance with Bristol-Myers Squibb and we and Bristol-Myers Squibb are presently conducting IND-enabling studies in preparation for the commencement of clinical development.

Other Programs. We have advanced small molecule compounds from a number of additional drug programs into various stages of preclinical and clinical development, including LX1033, an orally-delivered small molecule compound for the treatment of irritable bowel syndrome, LX2931, an orally-delivered small molecule compound for the treatment of autoimmune disease and LX7101, a topically-delivered small molecule compound for the treatment of glaucoma.

Drug Target Discoveries

Our internal drug discovery efforts were driven by a systematic, target biology-driven approach in which we used gene knockout technologies and an integrated platform of advanced medical technologies to systematically study the physiological and behavioral functions of almost 5,000 genes in mice and assessed the utility of the proteins encoded by the corresponding human genes as potential drug targets. We have identified and validated in living animals, or in vivo, more than 100 targets with promising profiles for drug discovery.

Our Commercialization Strategy
 
We are working both independently and through strategic collaborations and alliances with third parties to capitalize on our drug target discoveries and drug discovery and development programs. Consistent with this approach, we seek to retain exclusive rights to the benefits of certain drug discovery and development programs by developing and commercializing drug candidates from those programs internally. We seek to collaborate with other pharmaceutical and biotechnology companies, such as Ipsen and Sanofi, with respect to the development and commercialization of drug candidates from other programs, particularly when the collaboration may provide us with access to expertise and resources that we do not possess internally or are complementary to our own. We also seek to collaborate with other pharmaceutical and biotechnology companies, research institutes and academic institutions to capitalize on our drug target discoveries.
 
Strategic Collaborations

Sanofi. We entered into a collaboration and license agreement with Sanofi in November 2015 under which we granted Sanofi an exclusive, worldwide, royalty-bearing right and license to develop, manufacture and commercialize sotagliflozin. We received a $300 million upfront payment under the agreement and we are eligible to receive up to $430 million upon the achievement of specified development and regulatory milestones and up to $990 million upon the achievement of specified sales milestones. We are also entitled to tiered, escalating royalties ranging from low double digit percentages to forty percent of net sales of sotagliflozin, based on indication and territory, with royalties for the higher band of such range attributable to net sales for type 1 diabetes in the United States, and subject in each case to customary royalty reduction provisions. Royalties payable with respect to net sales of sotagliflozin for type 1 diabetes in the United States will also be reduced in the event we do not exercise our co-promotion option.

We are responsible for all clinical development activities relating to type 1 diabetes and retain an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotafliflozin for the treatment of type 1 diabetes in the United States. If we exercise our co-promotion option, we will fund forty percent of the commercialization costs relating to such co-promotion activities. Sanofi is responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide and is solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the United States. We will share in the funding of a portion of the planned type 2 diabetes development costs over the first three years of the collaboration, up to an aggregate of $100 million.

Ipsen. We entered into a license and collaboration agreement with Ipsen Pharma SAS in October 2014 under which we granted Ipsen an exclusive, royalty-bearing right and license to commercialize telotristat etiprate outside of the United States, Canada and Japan. The collaboration was expanded in March 2015 to include Canada. We received $24.5 million in upfront payments under the agreement and we are eligible to receive up to approximately $34 million upon the achievement of specified regulatory and commercial launch milestones and up to €72 million upon the achievement of specified sales milestones. We are also entitled to tiered, escalating royalties ranging from low twenties to mid-thirties percentages of net sales of telotristat etiprate in the licensed territory, subject to a credit for Ipsen’s payments to us for the manufacture and supply of such units of telotristat etiprate and customary royalty reduction provisions. Our receipt of these payments from Ipsen will trigger our obligation to make certain contingent payments to Symphony Icon Holdings LLC, or Holdings, pursuant to our prior arrangement with Holdings for the financing of the clinical development of telotristat etiprate.


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Subject to certain exceptions, we are responsible for conducting clinical trials required to obtain regulatory approval for telotristat etiprate in the European Union and will have the first right to conduct most other clinical trials of telotristat etiprate.
 
Bristol-Myers Squibb.  We established a drug discovery alliance with Bristol-Myers Squibb Company in December 2003 to discover, develop and commercialize small molecule drugs in the neuroscience field.  Bristol-Myers Squibb extended the target discovery term of the alliance in May 2006.  We initiated the alliance with a number of neuroscience drug discovery programs at various stages of development and used our gene knockout technologies to identify additional drug targets with promise in the neuroscience field.  For those targets that were selected for the alliance, we and Bristol-Myers Squibb are working together, on an exclusive basis, to identify, characterize and carry out the preclinical development of small molecule drugs, and share equally both in the costs and in the work attributable to those efforts.  As drugs resulting from the alliance enter clinical trials, Bristol-Myers Squibb will have the first option to assume full responsibility for clinical development and commercialization. We received $86 million in upfront payments and research funding under the agreement during the target discovery portion of the alliance, which expired in October 2009.  In addition, we are entitled to receive clinical and regulatory milestone payments ranging, depending on the timing and extent of our efforts in the alliance, up to $76 million for each drug developed by Bristol-Myers Squibb under the alliance.  We will also earn royalties on sales of drugs commercialized by Bristol-Myers Squibb under the alliance.

Genentech.  We established a drug discovery alliance with Genentech, Inc. in December 2002 to discover novel therapeutic proteins and antibody targets.  We and Genentech expanded the alliance in November 2005 for the advanced research, development and commercialization of new biotherapeutic drugs.  Under the original alliance agreement, we used our target validation technologies to discover the functions of secreted proteins and potential antibody targets identified through Genentech’s internal drug discovery research.  In the expanded alliance, we conducted additional, advanced research on a broad subset of those proteins and targets.  We have exclusive rights to develop and commercialize biotherapeutic drugs for two of these targets, while Genentech has exclusive rights to develop and commercialize biotherapeutic drugs for the other targets.  We retain certain other rights to discoveries made in the alliance, including non-exclusive rights, along with Genentech, for the development and commercialization of small molecule drugs addressing the targets included in the alliance. We received $58 million in upfront payments, research funding and research milestone payments under the agreement during the research collaboration term, which expired in November 2008.  In addition, we are entitled to receive clinical and regulatory milestone payments ranging, depending on the extent of our efforts in the alliance, up to $25 million for each drug target for which Genentech develops a biotherapeutic drug under the alliance.  We will also earn royalties on sales of biotherapeutic drugs commercialized by Genentech under the alliance.  Genentech is entitled to receive milestone payments and royalties on sales of biotherapeutic drugs which we develop or commercialize under the alliance.

Other Collaborations

We have established collaborations with a number of pharmaceutical and biotechnology companies, research institutes and academic institutions under which we have received fees in exchange for generating knockout mice for genes requested by the collaborator, providing phenotypic data with respect to such knockout mice or otherwise granting access to some of our technologies and discoveries.  In some cases, we remain eligible to receive milestone or royalty payments on the sale of mice and phenotypic data or on products that our collaborators discover or develop using our technology.

Our Executive Officers
 
Our executive officers and their ages and positions are listed below.
 
Name
Age
Position with the Company
Lonnel Coats
51
President and Chief Executive Officer and Director
Pablo Lapuerta, M.D.
52
Executive Vice President and Chief Medical Officer
Alan J. Main, Ph.D.
62
Executive Vice President, CMC and Supply Operations
Jeffrey L. Wade, J.D.
51
Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer
James F. Tessmer
56
Vice President, Finance and Accounting

Lonnel Coats has been our president and chief executive officer and a director since July 2014. From 1996 through June 2014, Mr. Coats served in a series of leadership positions at Eisai Inc. and Eisai Corporation of North America, most recently as chief executive officer from 2010 to June 2014 and president and chief operating officer from 2004 to 2010. Prior to joining Eisai, Mr. Coats spent eight years with Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson, where he held a variety of

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management and sales positions. Mr. Coats serves as a director of Blueprint Medicines Corporation and holds a B.P.A. from Oakland University.
Pablo Lapuerta, M.D. has been our executive vice president and chief medical officer since February 2015. Dr. Lapuerta served as our executive vice president, safety, pharmacovigilance and medical affairs and chief medical officer from August 2014 until February 2015 and was our executive vice president, clinical development and chief medical officer from February 2013 until August 2014 and senior vice president, clinical development and chief medical officer from 2011 until February 2013. From 2009 through 2010, Dr. Lapuerta served as vice president at Bristol-Myers Squibb Company with responsibility for global development of an Alzheimer’s disease drug candidate. From 2007 through 2009, Dr. Lapuerta was senior vice president, clinical strategy and chief medical officer of Cogentus Pharmaceuticals, Inc. and prior to that served in a variety of clinical development leadership roles at Bristol-Myers Squibb, where he worked for 11 years before joining Cogentus. He holds a B.A. in biology from Harvard College and an M.D. from Harvard Medical School.

Alan J. Main, Ph.D. has been our executive vice president, CMC and supply operations since February 2015. Dr. Main served as our executive vice president of pharmaceutical research from 2007 until February 2015 and was our senior vice president, Lexicon Pharmaceuticals from 2001 to 2007.  Dr. Main was president and chief executive officer of Coelacanth Corporation, a leader in using proprietary chemistry technologies to rapidly discover new chemical entities for drug development, from 2000 until our acquisition of Coelacanth in 2001.  Dr. Main was formerly senior vice president, U.S. Research at Novartis Pharmaceuticals Corporation, where he worked for 20 years before joining Coelacanth.  Dr. Main holds a B.S. from the University of Aberdeen, Scotland and a Ph.D. in organic chemistry from the University of Liverpool, England and completed postdoctoral studies at the Woodward Research Institute.

Jeffrey L. Wade, J.D. has been our executive vice president, corporate and administrative affairs and chief financial officer since February 2015. Mr. Wade served as our executive vice president, corporate development and chief financial officer from May 2010 until February 2015 and was our executive vice president and general counsel from 2000 until May 2010 and senior vice president and chief financial officer from 1999 to 2000.  From 1988 through 1998, Mr. Wade was a corporate securities and finance attorney with the law firm of Andrews & Kurth L.L.P., for the last two years as a partner, where he represented companies in the biotechnology, information technology and energy industries.  Mr. Wade is a member of the board of directors of the Texas Healthcare and Bioscience Institute.  He received his B.A. and J.D. from the University of Texas.
 
James F. Tessmer has been our vice president, finance and accounting since November 2007 and previously served as our senior director of finance from 2004 to November 2007 and director of finance from 2001 to 2004.  From January 1997 to 2001, Mr. Tessmer was assistant controller for Mariner Health Network, Inc. and prior to that served in a variety of financial and accounting management positions for HWC Distribution Corp. and American General Corporation.  Mr. Tessmer is a certified public accountant and received his B.B.A. from the University of Wisconsin – Milwaukee and his M.B.A. from the University of Houston.
 
Patents and Proprietary Rights
 
We will be able to protect our proprietary rights from unauthorized use by third parties only to the extent that those rights are covered by valid and enforceable patents or are effectively maintained as trade secrets. Accordingly, patents and other proprietary rights are an essential element of our business.  We own patent applications, and in some cases issued patents, covering each of our drug candidates in clinical development, including:

worldwide patent applications that claim telotristat etiprate, or LX1032, and associated crystalline forms, pharmaceutical compositions, and methods of manufacture and use, from which patents have granted in multiple jurisdictions, including ten in the United States; and
worldwide patent applications that claim sotagliflozin, or LX4211, and associated crystalline forms, pharmaceutical compositions, and methods of manufacture and use, from which patents have granted in multiple jurisdictions, including four in the United States.
Additionally, we hold rights to a number of patents and patent applications under license agreements with third parties.  Many of these licenses are nonexclusive, although some are exclusive in specified fields.  Most of the licenses have terms that extend for the life of the licensed patents.
 
Patents extend for varying periods according to the date of patent filing or grant and the legal term of patents in the various countries where patent protection is obtained. The actual protection afforded by a patent, which can vary from country

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to country, depends on the type of patent, the scope of its coverage and the availability of legal remedies in the country.  We have filed patent applications and hold issued patents covering each of our drug candidates in clinical development.  No United States patent that has issued or may issue based on a patent application we have filed relating to one of our drug candidates in clinical development has a normal expiration date earlier than 2026.

All of our employees, consultants and advisors are required to execute a proprietary information agreement upon the commencement of employment or consultation. In general, the agreement provides that all inventions conceived by the employee or consultant, and all confidential information developed or made known to the individual during the term of the agreement, shall be our exclusive property and shall be kept confidential, with disclosure to third parties allowed only in specified circumstances. We cannot assure you, however, that these agreements will provide useful protection of our proprietary information in the event of unauthorized use or disclosure of such information.

Our patent and intellectual property rights are subject to certain rights and uncertainties. See “Risks Related to Our Intellectual Property” under “Item 1A. Risk Factors.”
 
Competition
 
The biotechnology and pharmaceutical industries are highly competitive and characterized by rapid technological change.  We face significant competition in each of the aspects of our business from other pharmaceutical and biotechnology companies, as well as academic research institutions, clinical reference laboratories and governmental agencies that are pursuing research or development activities similar to ours. Many of our competitors have substantially greater research, development and commercialization capabilities and financial, scientific, marketing and human resources than we do.  As a result, our competitors may succeed in developing products earlier than we do, obtaining approvals from the FDA or other regulatory agencies for those products more rapidly than we do, developing products that are more effective than those we develop or commercializing products more effectively and profitably than we do.  Similarly, our collaborators face similar competition from other competitors who may succeed in developing products more quickly, developing products that are more effective than those developed by our collaborators or commercialize products more effectively and profitably than our collaborators.  Any products that we or our collaborators develop or discover are likely to be in highly competitive markets.

The competition for our drug candidates includes both marketed products and drug candidates that are being developed by others, including pharmaceutical products that are currently in a more advanced stage of clinical development or commercialization than are our own drug candidates.  These competitive marketed products and drug candidates include compounds that employ different mechanisms of action in addressing diseases and conditions for which we are developing our own drug candidates and, in some cases such as sotagliflozin, that employ the same or similar mechanisms of action.
 
We believe that our ability to successfully compete with these potentially competitive drug candidates and other competitive products currently on the market will depend on, among other things:
 
the efficacy, safety and reliability of our drug candidates;
 
our ability, and the ability of our collaborators, to complete preclinical and clinical development and obtain regulatory approvals for our drug candidates;
 
the timing and scope of regulatory approvals for our drug candidates;
 
our ability, and the ability of our collaborators, to obtain product acceptance by physicians and other health care providers and secure coverage and adequate reimbursement for product use in approved indications;
 
our ability, and the ability of our collaborators, to manufacture and sell commercial quantities of our products;

the skills of our employees and our ability to recruit and retain skilled employees;
 
protection of our intellectual property; and
 
the availability of substantial capital resources to fund development and commercialization activities.
 

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Government Regulation
 
Regulation of Pharmaceutical Products
 
The development, manufacture and sale of any pharmaceutical products developed by us or our collaborators will be subject to extensive regulation by United States and foreign governmental authorities, including federal, state and local authorities.  In the United States, new drugs are subject to regulation under the Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or the FDC Act.  The FDA and comparable governmental authorities regulate, among other things, the development, preclinical and clinical testing, manufacture, safety, efficacy, record keeping, reporting, labeling, storage, approval, advertising, promotion, sale, distribution and export of pharmaceutical products.
 
The standard process required by the FDA before a drug candidate may be marketed in the United States generally includes the following:
 
preclinical laboratory and animal tests performed under the FDA’s current Good Laboratory Practices regulations;
submission to the FDA of an Investigational New Drug application, or IND, which must become effective before human clinical trials may commence;
adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug candidate for its intended use;
pre-approval inspection of manufacturing facilities and selected clinical investigators for their compliance with FDA’s current Good Manufacturing Practices and Good Clinical Practices regulations;
submission and FDA approval of a New Drug Application, or NDA, for commercial marketing and sale, or of an NDA supplement, for approval of a new indication if the product is already approved for another indication.
     This process for the testing and approval of drug candidates requires substantial time, effort and financial resources.  Preclinical development of a drug candidate can take from one to several years to complete, with no guarantee that an IND based on those studies will become effective to even permit clinical testing to begin.  Before commencing the first clinical trial of a drug candidate in the United States, we must submit an IND to the FDA.  The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the clinical trial.  In such a case, we and the FDA must resolve any outstanding concerns before the clinical trial may begin.  Submission of an IND may not result in FDA authorization to commence a clinical trial. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development, and the FDA must grant permission for each clinical trial to start and continue.  Further, an independent institutional review board for each medical center proposing to participate in the clinical trial must review and approve the plan for any clinical trial before it commences at that center.  Regulatory authorities or an institutional review board or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.
 
For purposes of NDA approval, human clinical trials are typically conducted in three sequential phases that may overlap.
 
Phase 1 clinical trials are conducted in a limited number of healthy human volunteers or, in some cases, patients, to evaluate the safety, dosage tolerance, absorption, metabolism, distribution and excretion of the drug candidate;
Phase 2 clinical trials are conducted in groups of patients afflicted with a specified disease or condition to obtain preliminary data regarding efficacy as well as to further evaluate safety and optimize dosing of the drug candidate. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 clinical trials; and
Phase 3 clinical trials are conducted in larger patient populations at multiple clinical trial sites to obtain statistically significant evidence of the efficacy of the drug candidate for its intended use and to further test for safety in an expanded patient population.
In addition, the FDA may require, or companies may pursue, additional clinical trials after a product is approved.  These so-called Phase 4 studies may be made a condition to be satisfied after a drug receives approval. Failure to satisfy such post-marketing commitments can result in FDA enforcement action, up and to including withdrawal of NDA

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approval. The results of phase 4 studies can confirm the effectiveness of a drug candidate and can provide important safety information to augment the FDA’s adverse drug reaction reporting system.

After completion of clinical trials, FDA approval of an NDA must be obtained before a new drug may be marketed in the United States.  The submission of an NDA requires payment of a substantial user fee to the FDA. An NDA must contain, among other things, information on chemistry, manufacturing controls and potency and purity, non-clinical pharmacology and toxicology, human pharmacokinetics and bioavailability and clinical data.  There can be no assurance that the FDA will accept an NDA for filing and, even if accepted for filing, that approval will be granted.  The FDA may convene an advisory committee to provide clinical insight on NDA review questions. Among other things, the FDA reviews an NDA to determine whether a product is safe and effective for its intended use and whether the facility in which it is manufactured, processed, packed, or held meets standards designed to assure the product’s continued safety, purity and potency.  The FDA may deny approval of an NDA if the applicable regulatory criteria are not satisfied, or it may require additional clinical data or an additional pivotal Phase 3 clinical trial.  Even if such data are submitted, the FDA may ultimately decide that the NDA does not satisfy the criteria for approval.  Once issued, the FDA may withdraw product approval if ongoing regulatory standards are not met or if safety problems occur after the product reaches the market.  In addition, the FDA may require testing and surveillance programs to monitor the effect of approved products which have been commercialized, and the FDA has the power to prevent or limit further marketing of a product based on the results of these post-marketing programs.  Limited indications for use or other conditions on labeling, marketing and distribution could also be placed on any approvals that could restrict the commercial applications of a product or impose costly procedures in connection with the commercialization or use of the product.

In addition to obtaining FDA approval for each product, each drug manufacturing establishment must be inspected and approved by the FDA.  All manufacturing establishments are subject to inspections by the FDA and by other federal, state and local agencies and must comply with current Good Manufacturing Practices requirements.  Non-compliance with these requirements can result in, among other things, total or partial suspension of production, failure of the government to grant approval for marketing and withdrawal, suspension or revocation of marketing approvals.

Satisfaction of FDA requirements typically takes many years, with the actual time required varying substantially based on, among other things, the nature and complexity of the drug candidate and of the disease or condition.  Government regulation may delay or prevent marketing of drug candidates or new diseases for a considerable period of time and impose costly procedures upon our activities. Success in earlier-stage clinical trials does not ensure success in later-stage clinical trials.  Targets and pathways identified in vitro may be determined to be less relevant in clinical studies and results in animal model studies may not be predictive of human clinical results. Furthermore, data obtained from clinical activities is not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. Even if a drug candidate receives regulatory approval, the approval may be significantly limited to specific disease states, patient populations and dosages. Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market.
 
Once the FDA approves a product, a manufacturer must provide certain updated safety and efficacy information.  Product changes as well as certain changes in a manufacturing process or facility would necessitate additional FDA review and approval.  Other post-approval changes may also necessitate further FDA review and approval.  Additionally, a manufacturer must meet other requirements including those related to adverse event reporting and record keeping.
 
Any products manufactured or distributed by us pursuant to FDA approvals are subject to continuing regulation by the FDA, including record-keeping requirements and reporting of adverse experiences with the drug. Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with GMP, which impose certain procedural and documentation requirements upon us and our third-party manufacturers.

The FDA closely regulates the marketing and promotion of drugs.  A company can make only those claims relating to safety and efficacy that are approved by the FDA.  Failure to comply with these requirements can result in adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may, in their independent medical judgment, prescribe legally available drugs for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturers’ communications on the subject of off-label use. Additionally, a significant number of pharmaceutical companies have been the target of inquiries and investigations by various United States federal and state regulatory, investigative, prosecutorial and administrative entities in connection with the promotion of products for off-label uses and other sales practices. These investigations have alleged violations of various United States federal and state laws and regulations, including claims asserting antitrust violations,

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violations of the FDC Act, false claims laws, the Prescription Drug Marketing Act, anti-kickback laws, and other alleged violations in connection with the promotion of products for unapproved uses, pricing and Medicare and/or Medicaid reimbursement.
 
In addition to regulatory approvals that must be obtained in the United States, drugs are also subject to regulatory approval in other countries in which they are marketed.  The conduct of clinical trials of drugs in countries other than the United States is likewise subject to regulatory oversight in such countries.  The requirements governing the conduct of clinical trials, product licensing, pricing, and reimbursement vary widely from country to country.  No action can be taken to market any drug in a country until the regulatory authorities in that country have approved an appropriate application.  FDA approval does not assure approval by other regulatory authorities.  The current approval process varies from country to country, and the time spent in gaining approval varies from that required for FDA approval.  In some countries, the sale price of a drug or biologic product must also be approved.  The pricing review period often begins after marketing approval is granted.  Even if a foreign regulatory authority approves a drug, it may not approve satisfactory prices for the product.
 
Healthcare Regulation

Federal and state healthcare laws, including fraud and abuse and health information privacy and security laws, also apply to our business. If we fail to comply with those laws, we could face substantial penalties and our business, results of operations, financial condition and prospects could be adversely affected. The laws that may affect our ability to operate include, but are not limited to: the federal Anti-Kickback Statute, which prohibits. among other things, soliciting, receiving, offering or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs; and federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent. Additionally, we are subject to state law equivalents of each of the above federal laws, which may be broader in scope and apply regardless of payer, and many of which differ from each other in significant ways and may not have the same effect, further complicate compliance efforts.

Numerous federal and state laws, including state security breach notification laws, state health information privacy laws and federal and state consumer protection laws, govern the collection, use and disclosure of personal information. Other countries also have, or are developing, laws governing the collection, use and transmission of personal information. In addition, most healthcare providers who are expected to prescribe our products and from whom we obtain patient health information, are subject to privacy and security requirements under the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology and Clinical Health Act, or HIPPA. Although we are not directly subject to HIPPA, we could be subject to criminal penalties if we knowingly obtain individually identifiable health information from a HIPAA-covered entity, including healthcare providers, in a manner that is not authorized or permitted by HIPAA. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing amount of focus on privacy and data protection issues with the potential to affect our business, including recently enacted laws in a majority of states requiring security breach notification. These laws could create liability for us or increase our cost of doing business. International laws regulate the processing of personal data within Europe and between European countries and the United States. Failure to provide adequate privacy protections and maintain compliance with safe harbor mechanisms could jeopardize business transactions across borders and result in significant penalties.

In addition, the Patient Protection and Affordable Care Act, as amended by the Health Care Education Reconciliation Act, or the PPACA, created a federal requirement under the federal Open Payments program, that requires certain manufacturers to track and report to the Centers for Medicare and Medicaid Services, or CMS, annually certain payments and other transfers of value provided to physicians and teaching hospitals made in the previous calendar year. In addition, there are also an increasing number of state laws that require manufacturers to make reports to states on pricing and marketing information. These laws may affect our sales, marketing, and other promotional activities by imposing administrative and compliance burdens on us. In addition, given the lack of clarity with respect to these laws and their implementation, our reporting actions could be subject to the penalty provisions of the pertinent state, and soon federal, authorities.

Other Regulations
 
In addition to the foregoing, our business is subject to regulation under various state and federal environmental laws, including the Occupational Safety and Health Act, the Resource Conservation and Recovery Act and the Toxic Substances Control Act.  These and other laws govern our use, handling and disposal of various biological, chemical and radioactive substances used in and wastes generated by our operations.  We believe that we are in material compliance with applicable environmental laws and that our continued compliance with these laws will not have a material adverse effect on our

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business.  We cannot predict, however, whether new regulatory restrictions will be imposed by state or federal regulators and agencies or whether existing laws and regulations will adversely affect us in the future.
 
Research and Development Expenses
 
In 2015, 2014 and 2013, respectively, we incurred expenses of $95.2 million, $89.3 million and $89.7 million in company-sponsored as well as collaborative research and development activities, including $3.7 million, $4.0 million and $4.4 million of stock-based compensation expense in 2015, 2014 and 2013, respectively.
 
Employees and Consultants
 
As of February 29, 2016, we employed 120 persons, of whom 27 hold M.D. or Ph.D. degrees and another 28 hold other advanced degrees.  We believe that our relationship with our employees is good.


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Item 1A. Risk Factors
 
The following risks and uncertainties are important factors that could cause actual results or events to differ materially from those indicated by forward-looking statements.  The factors described below are not the only ones we face and additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.

 Risks Related to Our Need for Additional Financing and Our Financial Results
We will need additional capital in the future and, if it is unavailable, we will be forced to significantly curtail or cease our operations.  If it is not available on reasonable terms, we will be forced to obtain funds, if at all, by entering into financing agreements on unattractive terms.
As of December 31, 2015, we had $521.4 million in cash, cash equivalents and investments.  We anticipate that our existing capital resources and the cash and revenues we expect to derive from collaborations and other sources will enable us to fund our currently planned operations for at least the next two years. However, we caution you that we may generate less cash and revenues or incur expenses more rapidly than we currently anticipate. Our currently planned operations for the next twelve months include (a) continued preparations for the submission of an NDA for telotristat etiprate in the United States and, if approved, for the commercial launch of telotristat etiprate in the United States, (b) the completion of two pivotal Phase 3 clinical trials of sotagliflozin, which we expect to enroll an aggregate of approximately 1,500 patients with type 1 diabetes, (c) continued enrollment in a third Phase 3 clinical trial of sotagliflozin, which we expect to enroll approximately 1,400 patients with type 1 diabetes, and (d) the completion of a Phase 2 clinical trial of sotagliflozin in a younger adult type 1 diabetes population in collaboration with JDRF and a dose-ranging study of sotagliflozin in patients with type 1 diabetes. In addition, we cannot be certain as to what type and how many clinical trials the FDA, or equivalent foreign regulatory agencies, will require us to conduct in order to gain approval to market either telotristat etiprate or sotagliflozin.
Although difficult to accurately predict, the amount of our future capital requirements will be substantial and will depend on many factors, including:
our ability to obtain priority review on an NDA submission for telotristat etiprate and obtain regulatory approval for the marketing and sale of telotristat etiprate in the United States;
if approved, our ability to successfully commercialize telotristat etiprate in the United States;
the timing and progress of our two pivotal Phase 3 clinical trials of sotagliflozin in type 1 diabetes patients, including completing enrollment in the trials;
the timing and progress of our third Phase 3 clinical trial and other clinical trials of sotagliflozin in type 1 diabetes patients, including continuing enrollment of such trials on the timelines anticipated;
if approved, the progress and scope of Ipsen’s commercialization activities with respect to telotristat etiprate outside of the United States and Japan;
the progress and scope of Sanofi’s development activities with respect to sotagliflozin in type 2 diabetes patients;
the amount and timing of payments, if any, under our existing collaboration agreements with Sanofi, Ipsen and other entities and any future collaboration agreements;
the amount and timing of our development and commercialization expenditures;
future results from clinical trials of our drug candidates;
the cost and timing of regulatory approvals and commercialization of drug candidates that we successfully develop;
market acceptance of products that we successfully develop and commercially launch;
the effect of competing programs and products, and of technological and market developments;
the filing, maintenance, prosecution, defense and enforcement of patent claims and other intellectual property rights; and
the cost and timing of establishing or contracting for sales, marketing and distribution capabilities of any approved drug candidate.

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Our capital requirements have and will continue to increase substantially as we prepare for the commercial launch of telotristat etiprate in the United States, continue to conduct later stage clinical trials for telotristat etiprate and sotagliflozin and advance new drug candidates into clinical development.  Our capital requirements will also be affected by any expenditures we make in connection with license agreements and acquisitions of and investments in complementary products and technologies.  For all of these reasons, our future capital requirements cannot easily be quantified.
 
If our capital resources are insufficient to meet future capital requirements, we will need to raise additional funds to continue our currently planned operations.  Our ability to raise additional capital is dependent on a number of factors, including the market demand for our securities, which itself is subject to a number of pharmaceutical development and business risks and uncertainties, as well as uncertainty that we would be able to raise such additional capital at a price or on terms that are favorable to us. If we raise additional capital by issuing equity securities, our then-existing stockholders will experience dilution and the terms of any new equity securities may have preferences over our common stock.  If we raise additional capital by issuing debt securities, we may be required to pledge certain assets or enter into covenants that would restrict certain business activities or our ability to incur further indebtedness or otherwise contain unfavorable terms. We cannot be certain that additional financing, whether debt or equity, will be available in amounts or on terms acceptable to us, if at all.  We may be unable to raise sufficient additional capital on reasonable terms, and if so, we will be forced to significantly curtail or cease our operations or obtain funds, if at all, by entering into financing agreements on unattractive terms.
  
We have a history of net losses, and we expect to continue to incur net losses and may not achieve or maintain profitability.
 
We have incurred net losses since our inception, including net losses of $4.7 million for the year ended December 31, 2015, $100.3 million for the year ended December 31, 2014 and $104.1 million for the year ended December 31, 2013.  As of December 31, 2015, we had an accumulated deficit of $1.1 billion.  Because of the numerous risks and uncertainties associated with developing drugs, we are unable to predict the extent of any future losses or whether or when we will become profitable, if at all.  The size of our net losses will depend, in part, on the rate of decline or growth in our revenues and on the amount of our expenses. We expect net losses to increase significantly over the next several years as we expect to make significant investments in the development of telotristat etiprate and sotagliflozin and, if approved, the commercialization of telotristat etiprate in the United States.

We have derived substantially all of our revenues from strategic collaborations and other research and development collaborations and technology licenses.

Future revenues from our existing collaborations are uncertain because they depend, to a large degree, on the achievement of milestones and payment of royalties we earn from any future products developed under the collaborations. Our ability to secure future revenue-generating agreements will depend upon our ability to address the needs of our potential future collaborators and licensees, and to negotiate agreements that we believe are in our long-term best interests.  We may determine, as we have with certain of our drug candidates, including telotristat etiprate in the United States and Japan, that our interests are better served by retaining rights to our discoveries and advancing our therapeutic programs to a later stage, which could limit our near-term revenues and increase expenses.  Because of these and other factors, our operating results have fluctuated in the past and are likely to do so in the future, and we do not believe that period-to-period comparisons of our operating results are a good indication of our future performance. Given the current stage of our operations, we do not currently derive any revenues from sales of pharmaceutical products.
 
A large portion of our expenses is fixed, including expenses related to facilities and equipment.  In addition, we expect to spend significant amounts to fund our nonclinical and clinical development activities, including the conduct of ongoing and planned clinical trials for telotristat etiprate and sotagliflozin, and our activities relating to the preparation for and conduct of commercialization activities with respect to telotristat etiprate in the United States. As a result, we will need to generate substantial additional revenues to achieve profitability.  Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.

Our operating results have been and likely will continue to fluctuate, and we believe that period-to-period comparisons of our operating results are not a good indication of our future performance.
 
Our operating results and, in particular, our ability to generate additional revenues are dependent on many factors, including:

our success in obtaining regulatory approval for the marketing and sale of telotristat etiprate in the United States;

if approved, our ability to successfully commercialize telotristat etiprate in the United States;

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the amount and timing of payments, if any, under our existing collaboration agreements with Sanofi, Ipsen and other entities;

the success of our ongoing preclinical and clinical development efforts;

our success in establishing new collaborations and technology licenses, and the timing of such arrangements;
 
the success rate of our development efforts leading to opportunities for new collaborations and licenses, as well as milestone payments and royalties;
 
the timing and willingness of our collaborators to commercialize pharmaceutical products that would result in milestone payments and royalties; and
 
general and industry-specific economic conditions, which may affect our and our collaborators’ research and development expenditures.
 
Because of these and other factors, including the risks and uncertainties described in this section, our operating results have fluctuated in the past and are likely to do so in the future.  Due to the likelihood of fluctuations in our revenues and expenses, we believe that period-to-period comparisons of our operating results are not a good indication of our future performance.

We have substantial indebtedness that may limit cash flow available to invest in the ongoing needs of our business.

We have incurred $105.8 million of indebtedness and could in the future incur additional indebtedness beyond such amount. We are not restricted under the terms of our existing debt instruments from incurring additional debt. Our substantial debt combined with our other financial obligations and contractual commitments could have significant adverse consequences, including:

requiring us to dedicate a substantial portion of cash flow from operations to the payment of interest on, and principal of, our debt, which will reduce the amounts available to fund working capital, capital expenditures, product development efforts and other general corporate purposes;

increasing our vulnerability to adverse changes in general economic, industry and market conditions;

obligating us to restrictive covenants that may reduce our ability to take certain corporate actions or obtain further debt or equity financing;

limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and

placing us at a competitive disadvantage compared to our competitors that have less debt or better debt servicing options.

We intend to satisfy our current and future debt service obligations with our existing cash and cash equivalents and marketable securities and funds from external sources. However, we may not have sufficient funds or may be unable to arrange for additional financing to pay the amounts due under our existing debt. Funds from external sources may not be available on acceptable terms, if at all. In addition, a failure to comply with the covenants under our existing debt instruments could result in an event of default under those instruments. In the event of an acceleration of amounts due under our debt instruments as a result of an event of default, including upon the occurrence of an event that would reasonably be expected to have a material adverse effect on our business, operations, properties, assets or condition or a failure to pay any amount due, we may not have sufficient funds or may be unable to arrange for additional financing to repay our indebtedness or to make any accelerated payments, and the lenders could seek to enforce security interests in the collateral securing such indebtedness. In addition, the covenants under our existing debt instruments and the pledge of our assets as collateral limit our ability to obtain additional debt financing.


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We may not have the ability to raise the funds necessary to repurchase the notes evidencing our existing indebtedness upon a fundamental change, and our future debt may contain limitations on our ability to repurchase the notes.
Holders of the notes evidencing our existing indebtedness have the right to require us to repurchase their notes upon the occurrence of a fundamental change at a repurchase price equal to 100% of their principal amount, plus accrued and unpaid interest, if any. However, we may not have enough available cash or be able to obtain financing at the time we are required to make repurchases of notes surrendered therefor. In addition, our ability to repurchase the notes may be limited by law, by regulatory authority or by agreements governing our future indebtedness. Our failure to repurchase notes at a time when the repurchase is required by the indenture pursuant to which the notes were issued would constitute a default under the indenture. A default under the indenture or the fundamental change itself could also lead to a default under agreements governing our future indebtedness. If the repayment of the related indebtedness were to be accelerated after any applicable notice or grace periods, we may not have sufficient funds to repay the indebtedness and repurchase the notes.
 
Risks Related to Our Drug Candidates 
We are dependent on the successful development and commercialization of telotristat etiprate and sotagliflozin.
Our business is dependent on the successful development and commercialization of our two most advanced drug candidates, telotristat etiprate and sotagliflozin, and we are presently devoting most of our resources toward such objectives. If we or our collaborators are unable to successfully develop and commercialize telotristat etiprate and sotagliflozin, whether due to factors discussed in this “Risk Factors” section or otherwise, we may not generate adequate product revenues, if at all, and we may not become profitable.
Clinical testing of our drug candidates in humans is an inherently risky and time-consuming process that may fail to demonstrate safety and efficacy, which could result in the delay, limitation or prevention of regulatory approval.
In order to obtain regulatory approvals for the commercial sale of any products that we may develop, we or our collaborators are required to complete extensive clinical trials in humans to demonstrate the safety and efficacy of our drug candidates.  We or our collaborators may not be able to obtain authority from the FDA, or other equivalent foreign regulatory agencies to initiate or complete any clinical trials.  In addition, we have limited internal resources for making regulatory filings and interacting with regulatory authorities.
Clinical trials are inherently risky and the results from nonclinical testing of a drug candidate that is under development may not be predictive of results that will be obtained in human clinical trials.  In addition, the results of early human clinical trials may not be predictive of results that will be obtained in larger-scale, advanced stage clinical trials.  A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials, even after achieving positive results in earlier trials.  Although the results of our Phase 2 proof-of-concept clinical trials of sotagliflozin in type 1 and type 2 diabetes patients were positive, we cannot assure you that the ongoing Phase 3 clinical trials of sotagliflozin in type 1 diabetes patients or the planned Phase 3 clinical trials of sotagliflozin in type 2 diabetes patients will achieve positive results. Negative or inconclusive results from a nonclinical study or a clinical trial could cause us, our collaborators or the FDA or other equivalent foreign regulatory agencies to terminate a nonclinical study or clinical trial or require that we or our collaborators repeat or modify it.  For example, if the results of our ongoing dose-ranging study of sotagliflozin in type 1 diabetes patients are inconsistent with the design of our ongoing Phase 3 clinical trials of sotaglifozin in type 1 diabetes patients, such as suggesting that there is an effective dose of sotagliflozin lower than the doses we are studying in our Phase 3 clinical trials, we may be required to modify those Phase 3 clinical trials, which could significantly delay the completion of the trials. Furthermore, we, one of our collaborators or a regulatory agency with jurisdiction over the trials may suspend clinical trials at any time if the subjects or patients participating in such trials are being exposed to unacceptable health risks or for other reasons.
Any nonclinical or clinical test may fail to produce results satisfactory to the FDA or foreign regulatory authorities.  Nonclinical and clinical data can be interpreted in different ways, which could delay, limit or prevent regulatory approval. The FDA or institutional review boards at the medical institutions and healthcare facilities where we or our collaborators sponsor clinical trials may suspend any trial indefinitely if they find deficiencies in the conduct of these trials.  Clinical trials must be conducted in accordance with the FDA’s current Good Clinical Practices.  The FDA and these institutional review boards have authority to oversee our and our collaborators’ clinical trials, and the FDA may require large numbers of subjects or patients.  In addition, we or our collaborators must manufacture, or contract for the manufacture of, the drug candidates that we use in our clinical trials under the FDA’s current Good Manufacturing Practices.
 

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The rate of completion of clinical trials is dependent, in part, upon the rate of enrollment of patients.  Patient accrual is a function of many factors, including the size of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the study, the nature of the study, the existence of competitive clinical trials and the availability of alternative treatments.  Delays in planned patient enrollment may result in increased costs and prolonged clinical development, which in turn could allow our competitors to bring products to market before we do and impair our ability to commercialize our products or potential products.
 
We or our collaborators may not be able to successfully complete any clinical trial of a potential product within any specified time period.  In some cases, we or our collaborators may not be able to complete the trial at all. Moreover, clinical trials may not show our potential products to be both safe and effective.  Thus, the FDA and other regulatory authorities may not approve any products that we develop for any indication or may limit the approved indications or impose other conditions.
 
Our drug candidates are subject to a lengthy and uncertain regulatory process that may not result in the necessary regulatory approvals, which could adversely affect our and our collaborators’ ability to commercialize products.
 
Our drug candidates, including telotristat etiprate and sotagliflozin, as well as the activities associated with their research, development and commercialization, are subject to extensive regulation by the FDA and other regulatory agencies in the United States and by comparable authorities in other countries.  Failure to obtain regulatory approval for a drug candidate would prevent us from commercializing that drug candidate.  We and our collaborators have not received regulatory approval to market any of our drug candidates in any jurisdiction and have only limited experience in preparing and filing the applications necessary to gain regulatory approvals.  The process of obtaining regulatory approvals is expensive, and often takes many years, if approval is obtained at all, and can vary substantially based upon the type, complexity and novelty of the drug candidates involved.  Before a new drug application can be filed with the FDA, the drug candidate must undergo extensive clinical trials, which can take many years and may require substantial expenditures.  Any clinical trial may fail to produce results satisfactory to the FDA.  For example, the FDA could determine that the design of a clinical trial is inadequate to produce reliable results.  Furthermore, prior to approving a new drug, the FDA typically requires that the efficacy of the drug be demonstrated in two double-blind, controlled studies. In light of the unmet medical need in carcinoid syndrome, the results of our Phase 2 clinical trials of telotristat etiprate and our interactions with the FDA regarding those results, we believe that our single pivotal Phase 3 clinical trial of telotristat etiprate will be sufficient. However, the FDA has indicated that the trial must demonstrate statistically robust evidence of important clinical benefit and an acceptable safety profile in order to warrant consideration for marketing approval. If the FDA determines that our Phase 3 results do not have statistically robust results or clinically meaningful benefit, or if the FDA requires us to conduct additional Phase 3 clinical trials of telotristat etiprate prior to seeking marketing approval, we will incur significant additional development costs and commercialization of telotristat etiprate may be prevented or delayed. The regulatory process also requires nonclinical testing, and data obtained from nonclinical and clinical activities are susceptible to varying interpretations, which could delay, limit or prevent regulatory approval.  For example, we will need to complete certain nonclinical studies on a pre-approval basis in connection with our diabetes program, including carcinogenicity and toxicology. In our carcinoid syndrome program, we will need to conduct carcinogenicity studies on a post-approval basis and drug interaction studies on a pre-approval basis. Negative results in any of these nonclinical studies could delay or prevent approval of our product candidates. In addition, delays or rejections may be encountered based upon changes in regulatory policy for product approval during the period of product development and regulatory agency review.  Changes in regulatory approval policy, regulations or statutes or the process for regulatory review during the development or approval periods of our drug candidates may cause delays in the approval or rejection of an application. Even if the FDA or a comparable authority in another country approves a drug candidate, the approval may impose significant restrictions on the indicated uses, conditions for use, labeling, advertising, promotion, marketing and/or production of such product and may impose ongoing requirements for post-approval studies, including additional research and development and clinical trials.  These agencies also may impose various civil or criminal sanctions for failure to comply with regulatory requirements, including withdrawal of product approval.
 
If our potential products receive regulatory approval, we or our collaborators will remain subject to extensive and rigorous ongoing regulation.
 
If we or our collaborators obtain initial regulatory approvals from the FDA or foreign regulatory authorities for any products that we may develop, we or our collaborators will be subject to extensive and rigorous ongoing domestic and foreign government regulation of, among other things, the research, development, testing, manufacture, labeling, promotion, advertising, distribution and marketing of our products and drug candidates.  The failure to comply with these requirements or the identification of safety problems during commercial marketing could lead to the need for product marketing restrictions, product withdrawal or recall or other voluntary or regulatory action, which could delay further marketing until the product is brought into compliance.  The failure to comply with these requirements may also subject us or our collaborators to stringent penalties.

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The commercial success of any products that we or our collaborators may develop will depend upon the degree of market acceptance of our products among physicians, patients, health care payors, private health insurers and the medical community.
 
Even if approved by the relevant regulatory authority, our or our collaborators’ ability to commercialize any products that we or they may develop will be highly dependent upon the extent to which these products gain market acceptance among physicians, patients, health care payors, such as Medicare and Medicaid, private health insurers, including managed care organizations and group purchasing organizations, and the medical community.  If these products do not achieve an adequate level of acceptance, we may not generate adequate product revenues, if at all, and we may not become profitable.  The degree of market acceptance of our drug candidates, if approved for commercial sale, will depend upon a number of factors, including:
 
the effectiveness, or perceived effectiveness, of our products in comparison to competing products;
 
the existence of any significant side effects, as well as their severity in comparison to any competing products;
 
potential advantages or disadvantages in relation to alternative treatments;

indications for which our products may be approved;
 
the ability to offer our products for sale at competitive prices;
 
relative convenience and ease of administration;
 
the strength of marketing and distribution support; and
 
sufficient third-party coverage or reimbursement.
 
If we are unable to establish sales, marketing and distribution capabilities or enter into agreements with third parties to market and sell our drug candidates, we may be unable to generate product revenues.
 
Our commercialization strategy includes the commercialization of telotristat etiprate on our own behalf in the United States and an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotafliflozin for the treatment of type 1 diabetes in the United States. We have no experience as a company in the sales, marketing and distribution of pharmaceutical products and are presently building our commercial organization.  We may not be able to correctly judge the size and experience of the sales and marketing force and the scale of distribution necessary to successfully market and sell our drug candidates. Developing and maintaining a sales and marketing force is expensive and time-consuming, could delay any product launch, and we may never be able to develop this capacity.  Such expenses may be disproportional compared to the revenues we may be able to generate on sales of our drug candidates. To the extent that we enter into arrangements with third parties to provide sales, marketing and distribution services, our product revenues are likely to be lower than if we market and sell any products that we develop ourselves.  If we are unable to establish adequate sales, marketing and distribution capabilities, independently or with others, we may not be able to generate product revenues.
 
We are subject to certain healthcare laws, regulation and enforcement; our failure to comply with those laws could have a material adverse effect on our results of operations and financial condition.

We are or will be subject to certain healthcare laws and regulations and enforcement by the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include, without limitation:

the federal Anti-Kickback Law, which constrains our business activities, which will include our marketing practices, educational programs, pricing policies, and relationships with healthcare providers or other entities, by prohibiting, among other things, persons and entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

federal civil and criminal false claims laws and civil monetary penalty laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payers that are false or fraudulent;


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federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

HIPAA, as amended by HITECH, and their implementing regulations, which impose certain requirements relating to the privacy, security and transmission of individually identifiable health information;

state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts;

the Foreign Corrupt Practices Act, a United States law which regulates certain financial relationships with foreign government officials (which could include, for example, certain medical professionals);

federal and state consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

state and federal government price reporting laws that require us to calculate and report complex pricing metrics to government programs, where such reported priced may be used in the calculation of reimbursement and/or discounts on our marketed drugs (participation in these programs and compliance with the applicable requirements may subject us to potentially significant discounts on our products, increased infrastructure costs, and potentially limit our ability to offer certain marketplace discounts); and

state and federal marketing expenditure tracking and reporting laws, which generally require certain types of expenditures in the United States to be tracked and reported (compliance with such requirements may require investment in infrastructure to ensure that tracking is performed properly, and some of these laws result in the public disclosure of various types of payments and relationships, which could potentially have a negative effect on our business and/or increase enforcement scrutiny of our activities).

In addition, certain marketing practices, including off-label promotion, may also violate certain federal and state health regulatory fraud and abuse laws as well as false claims laws. If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we, or our officers or employees, may be subject to penalties, including administrative civil and criminal penalties, damages, fines, withdrawal of regulatory approval, the curtailment or restructuring of our operations, the exclusion from participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability to sell our drug candidates or operate our business and also adversely affect our financial results.

Numerous federal and state laws, including state security breach notification laws, state health information privacy laws and federal and state consumer protection laws, govern the collection, use and disclosure of personal information. Other countries also have, or are developing, laws governing the collection, use and transmission of personal information. In addition, most healthcare providers who may be expected to prescribe our products and from whom we may obtain patient health information are subject to privacy and security requirements under the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA. Although we are not directly subject to HIPAA, we could be subject to criminal penalties if we knowingly obtain individually identifiable health information from a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing amount of focus on privacy and data protection issues with the potential to affect our business, including recently enacted laws in a majority of states requiring security breach notification. These laws could create liability for us or increase our cost of doing business. International laws, such as the EU Data Privacy Directive (95/46/EC) and Swiss Federal Act on Data Protection, regulate the processing of personal data within Europe and between European countries and the United States. Failure to provide adequate privacy protections and maintain compliance with safe harbor mechanisms could jeopardize business transactions across borders and result in significant penalties.

If we are unable to obtain adequate coverage and reimbursement from third-party payors for any products that we or our collaborators may develop, our revenues and prospects for profitability will suffer.
 
Our ability to successfully commercialize any products that we or our collaborators may develop will be highly dependent on the extent to which coverage and reimbursement for our products will be available from third-party payors, including governmental payors, such as Medicare and Medicaid, and private health insurers, including managed care organizations and group purchasing organizations.  Many patients will not be capable of paying themselves for some or all of

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the products that we or our collaborators may develop and will rely on third-party payors to pay for, or subsidize, their medical needs.  If third-party payors do not provide coverage or reimbursement for any products that we or our collaborators may develop, our revenues and prospects for profitability will suffer.  In addition, even if third-party payors provide some coverage or reimbursement for our products, the availability of such coverage or reimbursement for prescription drugs under private health insurance and managed care plans often varies based on the type of contract or plan purchased.
 
In addition, in some foreign countries, particularly the countries in the European Union, the pricing of prescription pharmaceuticals is subject to governmental control.  In these countries, price negotiations with governmental authorities can take six to 12 months or longer after the receipt of regulatory marketing approval for a product.  To obtain reimbursement and/or pricing approval in some countries, we or our collaborators may be required to conduct a clinical trial that compares the cost effectiveness of our drug candidates or products to other available therapies.  The conduct of such a clinical trial could be expensive and result in delays in the commercialization of our drug candidates.  Third-party payors are challenging the prices charged for medical products and services, and many third-party payors limit reimbursement for newly approved health care products.  In particular, third-party payors may limit the indications for which they will reimburse patients who use any products that we or our collaborators may develop.  Cost-control initiatives could decrease prices we or our collaborators might establish for products that may be developed, which would result in lower product revenues to us.
 
Current healthcare laws and regulations and future legislative or regulatory reforms to the healthcare system may negatively affect our revenues and prospects for profitability.

A primary trend in the United States and some foreign countries is toward reform and cost containment in the health care industry.  The United States and some foreign jurisdictions are considering or have enacted a number of legislative and regulatory proposals that may have the effect of reducing the prices that we are able to charge for products we develop. For example, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or collectively the PPACA, substantially modifies the framework by which healthcare is financed by both governmental and private insurers in the United States. A number of provisions contained in the PPACA have the potential to significantly affect the pharmaceutical industry, including:
 
an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs, apportioned among these entities according to their market share in certain governmental health programs, not including orphan drug sales;
 
expansion of eligibility criteria and increases in the rebates manufacturers must pay under certain Medicaid programs;
 
a new Medicare Part D coverage program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during any coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
 
extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program; and

certain reporting requirements relating to financial arrangements with, and other “transfers of value” to, physicians.

As a result of the overall trend towards cost-effectiveness criteria and managed healthcare in the United States, third-party payers are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs. They may use tiered reimbursement and may adversely affect demand for our drug candidates by placing them in an expensive tier. They may also refuse to provide any coverage of uses of approved products for medical indications other than those for which the FDA has granted market approvals. As a result, significant uncertainty exists as to whether and how much third-party payers will reimburse for newly approved drugs, which in turn will put pressure on the pricing of drugs. Further, we do not have experience in ensuring approval by applicable third-party payers outside of the United States for coverage and reimbursement of pharmaceutical products. We also anticipate pricing pressures in connection with the sale of our drug candidates due to the increasing influence of health maintenance organizations and additional legislative proposals.

The PPACA and other healthcare reform measures which may be adopted in the future in the United States and foreign jurisdictions may result in more rigorous coverage criteria and significant downward pressure on the prices drug manufacturers may charge. As a result, our revenues and prospects for profitability could be significantly harmed.


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Our competitors may develop products that make our or our collaborators’ products obsolete.
 
The pharmaceutical and biotechnology industries are highly fragmented and are characterized by rapid technological change.  We and our collaborators face, and will continue to face, intense competition from biotechnology and pharmaceutical companies, as well as academic research institutions, clinical reference laboratories and government agencies that are pursuing research and development activities similar to ours.  In addition, significant delays in the development of our drug candidates could allow our competitors to bring products to market before us, which would impair our or our collaborators’ ability to commercialize our drug candidates.  Any products that we or our collaborators develop will compete in highly competitive markets.  Further, our competitors may be more effective at using their technologies to develop commercial products.  Many of the organizations competing with us have greater capital resources, larger research and development staff and facilities, more experience in obtaining regulatory approvals and more extensive product manufacturing and marketing capabilities.  As a result, our competitors may be able to more easily develop products that would render our products, and those of our collaborators, obsolete and noncompetitive.  For example, drug candidates are currently being developed by other pharmaceutical companies for the treatment of type 2 diabetes that act through SGLT2, one of the targets of sotagliflozin, which are in more advanced stages of development than sotagliflozin or have been approved for commercial sale by the FDA or other regulatory agencies.  In addition, there may be drug candidates of which we are not aware at an earlier stage of development that may compete with our drug candidates.
 
We may not be able to manufacture our drug candidates in commercial quantities, which would prevent us from commercializing our drug candidates.
 
To date, our drug candidates have been manufactured in small quantities for nonclinical and clinical trials.  If any of these drug candidates are approved by the FDA or other regulatory agencies for commercial sale, we or our collaborators will need to manufacture them in larger quantities.  We are required under our collaboration agreement to supply Ipsen’s commercial requirements of telotristat etiprate. We may not be able to successfully increase the manufacturing capacity, whether in collaboration with third-party manufacturers or on our own, for any of our drug candidates in a timely or economic manner, or at all.  Significant scale-up of manufacturing may require additional validation studies, which the FDA must review and approve.  If we or our collaborators are unable to successfully increase the manufacturing capacity for a drug candidate, the regulatory approval or commercial launch of that drug candidate may be delayed or there may be a shortage in supply.  Our drug candidates require precise, high-quality manufacturing.  The failure to achieve and maintain these high manufacturing standards, including the incidence of manufacturing errors, could result in patient injury or death, product recalls or withdrawals, delays or failures in product testing or delivery, cost overruns or other problems that could seriously hurt our business.

Risks Related to Our Relationships with Third Parties
 
We are significantly dependent upon our collaborations with Ipsen, Sanofi and other pharmaceutical and biotechnology companies.  If pharmaceutical products are not successfully and timely developed and commercialized under our collaborations, our opportunities to generate revenues from milestones and royalties will be greatly reduced.
 
We have entered into collaboration agreements with Ipsen for the commercialization of telotristat etiprate outside of the United States and Japan and with Sanofi for the worldwide development and commercialization of sotagliflozin. We have also established collaborative arrangements with other pharmaceutical and biotechnology companies with respect to the research, development and commercialization of drug candidates from other programs. We have derived a substantial majority of our revenues to date from these strategic collaborations and other research and development collaborations and technology licenses. Future revenues from our existing collaborations depend upon the achievement of milestones and payment of royalties we earn from any future products developed under the collaborations.  If our relationship terminates with any of our collaborators, particularly Ipsen and Sanofi, our reputation in the business and scientific community may suffer and revenues will be negatively impacted to the extent such losses are not offset by additional collaboration agreements.  If milestones are not achieved under our collaborations or our collaborators are unable to successfully develop and commercialize products from which milestones and royalties are payable, we will not earn the revenues contemplated by those collaborations.
 
We have limited or no control over the resources that any collaborator may devote to the development and commercialization of products under our alliances.  Any of our present or future collaborators may not perform their obligations as expected. These collaborators may breach or terminate their agreements with us or otherwise fail to conduct research, development or commercialization activities successfully or in a timely manner.  Further, our collaborators may elect not to develop pharmaceutical products arising out of our collaborative arrangements or may not devote sufficient resources to the development, regulatory approval, manufacture, marketing or sale of these products.  If any of these events occurs, we may

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not receive collaboration revenue or otherwise realize anticipated benefits from such collaborations, our product development efforts may be delayed and our business, operating results and financial condition could be adversely affected.

Conflicts with our collaborators could jeopardize the success of our collaborative agreements and harm our product development efforts.
We may pursue opportunities in specific disease and therapeutic modality fields that could result in conflicts with our collaborators, if any of our collaborators takes the position that our internal activities overlap with those activities that are exclusive to our collaboration.  Moreover, disagreements could arise with our collaborators over rights to our intellectual property or our rights to share in any of the future revenues of compounds or therapeutic approaches developed by our collaborators.  Any conflict with or among our collaborators could result in the termination of our collaborative agreements, delay collaborative research or development activities, impair our ability to renew or obtain future collaborative agreements or lead to costly and time consuming litigation.  Conflicts with our collaborators could also have a negative impact on our relationship with existing collaborators, materially impairing our business and revenues.  Some of our collaborators are also potential competitors or may become competitors in the future.  Our collaborators could develop competing products, preclude us from entering into collaborations with their competitors or terminate their agreements with us prematurely.  Any of these events could harm our product development efforts.
We rely on third parties to carry out drug development activities.
We rely on clinical research organizations and other third party contractors to carry out many of our drug development activities, including the performance of nonclinical laboratory and animal tests under the FDA’s current Good Laboratory Practices regulations and the conduct of clinical trials of our drug candidates in accordance with protocols we establish.  If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, our drug development activities may be delayed, suspended or terminated.  Such a failure by these third parties could significantly impair our ability to develop and commercialize the affected drug candidates.
We lack the capability to manufacture materials for nonclinical studies, clinical trials or commercial sales and rely on third parties to manufacture our drug candidates, which may harm or delay our product development and commercialization efforts.
We currently do not have the manufacturing capabilities or experience necessary to produce materials for nonclinical studies, clinical trials or commercial sales and intend in the future to continue to rely on collaborators and third-party contractors to produce such materials.  We will rely on selected manufacturers to deliver materials on a timely basis and to comply with applicable regulatory requirements, including the current Good Manufacturing Practices of the FDA, which relate to manufacturing and quality control activities.  These manufacturers may not be able to produce material on a timely basis or manufacture material at the quality level or in the quantity required to meet our development timelines and applicable regulatory requirements.  In addition, there are a limited number of manufacturers that operate under the FDA’s current Good Manufacturing Practices and that are capable of producing such materials, and we may experience difficulty finding manufacturers with adequate capacity for our needs.  If we are unable to contract for the production of sufficient quantity and quality of materials on acceptable terms, our product development and commercialization efforts may be delayed.  Moreover, noncompliance with the FDA’s current Good Manufacturing Practices can result in, among other things, fines, injunctions, civil and criminal penalties, product recalls or seizures, suspension of production, failure to obtain marketing approval and withdrawal, suspension or revocation of marketing approvals.
Risks Related to Our Intellectual Property
If we are unable to adequately protect our intellectual property, third parties may be able to use our products and technologies, which could adversely affect our ability to compete in the market.
Our success will depend in part upon our ability to obtain patents and maintain adequate protection of the intellectual property related to our products and technologies.  The patent positions of biotechnology companies, including our patent position, are generally uncertain and involve complex legal and factual questions.  We will be able to protect our intellectual property rights from unauthorized use by third parties only to the extent that our products and technologies are covered by valid and enforceable patents or are effectively maintained as trade secrets.  We will continue to apply for patents covering our products and technologies as and when we deem appropriate.  Pending patent applications do not provide protection against competitors because they are not enforceable until they issue as patents.  Further, the disclosures contained in our current and future patent applications may not be sufficient to meet statutory requirements for patentability.  Once issued, patents still may not provide commercially meaningful protection.  Our existing patents and any future patents we obtain may not be sufficiently broad to prevent others from developing competing products and technologies.  Furthermore, others may independently

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develop similar or alternative products or technologies or design around our patents.  If anyone infringes upon our or our collaborators’ patent rights, enforcing these rights may be difficult, costly and time-consuming and, as a result, it may not be cost-effective or otherwise expedient to pursue litigation to enforce those patent rights.  In addition, our patents may be challenged or invalidated or may fail to provide us with any competitive advantages, if, for example, others were the first to invent or to file patent applications for these inventions.
Because patent applications can take many years to issue, there may be currently pending applications which may later result in issued patents that cover the production, manufacture, commercialization or use of our drug targets or drug candidates.   If any such patents are issued to other entities, we will be unable to obtain patent protection for the same or similar discoveries that we make relating to our drug targets or drug candidates.  Moreover, we may be blocked from using our drug targets or drug candidates or developing or commercializing our drug candidates, or may be required to obtain a license that may not be available on reasonable terms, if at all.  Further, others may discover uses for our drug targets and drug candidates other than those covered in our issued or pending patents, and these other uses may be separately patentable.  Even if we have a patent claim on a particular technology or product, the holder of a patent covering the use of that technology or product could exclude us from selling a product that is based on the same use of that product.
The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States, and many companies have encountered significant problems in protecting and defending such rights in foreign jurisdictions.  Many countries, including certain countries in Europe, have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties (for example, if the patent owner has failed to “work” the invention in that country or the third party has patented improvements).  In addition, many countries limit the enforceability of patents against government agencies or government contractors.  In these countries, the patent owner may have limited remedies, which could materially diminish the value of the patent.  Compulsory licensing of life-saving drugs is also becoming increasingly popular in developing countries either through direct legislation or international initiatives.  Such compulsory licenses could be extended to include some of our drug candidates, which could limit our potential revenue opportunities.  Moreover, the legal systems of certain countries, particularly certain developing countries, do not favor the aggressive enforcement of patent and other intellectual property protection, which makes it difficult to stop infringement.
We rely on trade secret protection for our confidential and proprietary information.  We have taken security measures to protect our proprietary information and trade secrets, but these measures may not provide adequate protection.  While we seek to protect our proprietary information by entering into confidentiality agreements with employees, collaborators and consultants, we cannot assure you that our proprietary information will not be disclosed, or that we can meaningfully protect our trade secrets.  In addition, our competitors may independently develop substantially equivalent proprietary information or may otherwise gain access to our trade secrets.
We may be involved in patent litigation and other disputes regarding intellectual property rights and may require licenses from third parties for our planned nonclinical and clinical development and commercialization activities.  We may not prevail in any such litigation or other dispute or be able to obtain required licenses.
Our nonclinical and clinical development efforts as well as our potential products and those of our collaborators may give rise to claims that they infringe the patents of others.  We are aware that other companies and institutions are developing products acting through the same drug targets through which some of our drug candidates currently in clinical development act, have conducted research on many of the same targets that we have identified and have filed patent applications potentially covering drug targets that we have identified and certain therapeutic products addressing such targets.  In some cases, patents have issued from these applications.  In addition, many companies and institutions have well-established patent portfolios directed to common techniques, methods and means of developing, producing and manufacturing pharmaceutical products.  These or other companies or institutions could bring legal actions against us or our collaborators for damages or to stop us or our collaborators from engaging in certain nonclinical or clinical development activities or from manufacturing and marketing therapeutic products that allegedly infringe their patent rights.  If any of these actions are successful, in addition to our potential liability for damages, these entities would likely require us or our collaborators to obtain a license in order to continue engaging in the infringing activities or to manufacture or market the infringing therapeutic products or may force us to terminate such activities or manufacturing and marketing efforts.
We may need to pursue litigation against others to enforce our patents and intellectual property rights and may be the subject of litigation brought by third parties to enforce their patent and intellectual property rights.  In addition, we may become involved in litigation based on intellectual property indemnification undertakings that we have given to certain of our collaborators.  Patent litigation is expensive and requires substantial amounts of management attention.  The eventual outcome of any such litigation is uncertain and involves substantial risks.

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We believe that there will continue to be significant litigation in our industry regarding patent and other intellectual property rights.  We have expended and many of our competitors have expended and are continuing to expend significant amounts of time, money and management resources on intellectual property litigation.  If we become involved in future intellectual property litigation, it could consume a substantial portion of our resources and could negatively affect our results of operations.
We have not sought patent protection outside of the United States for some of our inventions, and some of our licensed patents only provide coverage in the United States.  As a result, our international competitors could be granted foreign patent protection with respect to our discoveries.
 
We have decided not to pursue patent protection with respect to some of our inventions outside the United States, both because we do not believe it is cost-effective and because of confidentiality concerns.  Accordingly, our international competitors could develop, and receive foreign patent protection for, genes or gene sequences, uses of those genes or gene sequences, gene products and drug targets, assays for identifying potential therapeutic products, potential therapeutic products and methods of treatment for which we are seeking United States patent protection.
 
We may be subject to damages resulting from claims that we, our employees or independent contractors have wrongfully used or disclosed alleged trade secrets of their former employers.
 
Many of our employees and independent contractors were previously employed at universities, other biotechnology or pharmaceutical companies, including our competitors or potential competitors.  We may be subject to claims that these employees, independent contractors or we have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of their former employers.  Litigation may be necessary to defend against these claims.  Even if we are successful in defending against these claims, litigation could result in substantial costs and divert management’s attention.  If we fail in defending such claims, in addition to paying money claims, we may lose valuable intellectual property rights or personnel.  A loss of key research personnel and/or their work product could hamper or prevent our ability to commercialize certain drug candidates, which could severely harm our business.
 
Risks Related to Employees, Advisors and Facilities Operations
 
The loss of key personnel or the inability to attract and retain additional personnel could impair our ability to expand our operations.
 
We are highly dependent upon the principal members of our management and scientific staff, the loss of whose services might adversely impact the achievement of our objectives.  Recruiting and retaining qualified medical, clinical and scientific personnel will be critical to support activities related to advancing our nonclinical and clinical development programs, and to support our collaborative arrangements.  Competition is intense for experienced medical and clinical personnel, in particular, and we may be unable to retain or recruit medical and clinical personnel with the expertise or experience necessary to allow us to pursue collaborations, develop our products or expand our operations to the extent otherwise possible.  Further, all of our employees are employed “at will” and, therefore, may leave our employment at any time.
 
Our collaborations with outside scientists may be subject to restriction and change.
 
We work with scientific and clinical advisors and collaborators at academic and other institutions that assist us in our nonclinical and clinical development efforts.  These advisors and collaborators are not our employees and may have other commitments that limit their availability to us.  Although these advisors and collaborators generally agree not to perform competing work, if a conflict of interest between their work for us and their work for another entity arises, we may lose their services.  In such a circumstance, our development efforts with respect to the matters on which they were working may be significantly delayed or otherwise adversely affected.  In addition, although our advisors and collaborators sign agreements not to disclose our confidential information, it is possible that valuable proprietary knowledge may become publicly known through them.

Security breaches may disrupt our operations and harm our operating results.

Our network security and data recovery measures may not be adequate to protect against computer viruses, break-ins, and similar disruptions from unauthorized tampering with our computer systems. The misappropriation, theft, sabotage or any other type of security breach with respect to any of our proprietary and confidential information that is electronically stored, including research or clinical data, could have a material adverse impact on our business, operating results and financial condition. Additionally, any break-in or trespass of our facilities that results in the misappropriation, theft, sabotage or any

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other type of security breach with respect to our proprietary and confidential information, including research or clinical data, or that results in damage to our research and development equipment and assets could have a material adverse impact on our business, operating results and financial condition.

Risks Related to Environmental and Product Liability
 
We use hazardous chemicals and radioactive and biological materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly.
 
Our research and development processes have historically involved the controlled use of hazardous materials, including chemicals and radioactive and biological materials.  Our operations have produced hazardous waste products.  We cannot eliminate the risk of accidental contamination or discharge and any resultant injury from these materials.  Federal, state and local laws and regulations govern the use, manufacture, storage, handling and disposal of hazardous materials.  We may face liability for any injury or contamination that results from our use or the use by third parties of these materials, and such liability may exceed our insurance coverage and our total assets.  Compliance with environmental laws and regulations may be expensive, and current or future environmental regulations may impair our research, development and production efforts.
 
In addition, our collaborators may use hazardous materials in connection with our collaborative efforts. In the event of a lawsuit or investigation, we could be held responsible for any injury caused to persons or property by exposure to, or release of, these hazardous materials used by these parties.  Further, we may be required to indemnify our collaborators against all damages and other liabilities arising out of our development activities or products produced in connection with these collaborations.
 
We may be sued for product liability.
 
We or our collaborators may be held liable if any product that we or our collaborators develop, or any product that is made with the use or incorporation of any of our technologies, causes injury or is found otherwise unsuitable during product testing, manufacturing, marketing or sale.  Although we currently have and intend to maintain product liability insurance, this insurance may become prohibitively expensive or may not fully cover our potential liabilities.  Our inability to obtain sufficient insurance coverage at an acceptable cost or otherwise to protect against potential product liability claims could prevent or inhibit the commercialization of products developed by us or our collaborators.  If we are sued for any injury caused by our or our collaborators’ products, our liability could exceed our total assets.
 
Risks Related to Our Common Stock
 
Invus, L.P., Invus C.V. and their affiliates own a controlling interest in our outstanding common stock and may have interests which conflict with those of our other stockholders.
 
Invus, L.P. and Invus C.V., which we collectively refer to as Invus, and their affiliates currently own approximately 59.6% of the outstanding shares of our common stock and are thereby able to control the election and removal of our directors and determine our corporate and management policies, including potential mergers or acquisitions, asset sales, the amendment of our articles of incorporation or bylaws and other significant corporate transactions. This concentration of ownership may delay or deter possible changes in control of our company, which may reduce the value of an investment in our common stock. The interests of Invus and its affiliates may not coincide with the interests of other holders of our common stock.

Conversion of the notes evidencing our current indebtedness may dilute the ownership interest of our existing stockholders, including holders who had previously converted their notes, or may otherwise depress the price of our common stock.

The conversion of some or all of the notes evidencing our current indebtedness will dilute the ownership interests of existing stockholders to the extent we deliver shares upon conversion of any of the notes. Any sales in the public market of the common stock issuable upon such conversion could adversely affect prevailing market prices of our common stock. In addition, the existence of the notes may encourage short selling by market participants because the conversion of the notes could be used to satisfy short positions, or anticipated conversion of the notes into shares of our common stock could depress the price of our common stock.


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Invus has additional rights under our stockholders agreement with Invus, L.P. which provides Invus with substantial influence over certain significant corporate matters.

Under our stockholders’ agreement with Invus, L.P., Invus has the right to designate a number of directors equal to the percentage of all the outstanding shares of our common stock owned by Invus and its affiliates, rounded up to the nearest whole number of directors. Invus has designated three of the nine current members of our board of directors. While Invus has not presently exercised its director designation rights in full, it may exercise them at any time in the future in its sole discretion. To facilitate the exercise of such rights, we have agreed, upon written request from Invus, to take all necessary steps in accordance with our obligations under the stockholders’ agreement to (1) increase the number of directors to the number specified by Invus (which number shall be no greater than reasonably necessary for the exercise of Invus’ director designation rights under the stockholders’ agreement) and (2) cause the appointment to the newly created directorships of directors so designated by Invus pursuant to its rights under the stockholders’ agreement.

Invus also has the right to require proportionate representation of Invus-appointed directors on the audit, compensation and corporate governance committees of our board of directors, subject to certain restrictions. Invus-designated directors currently serve as one of the three members of each of the compensation committee and the corporate governance committee of our board of directors. No Invus-designated directors currently serve on the audit committee of our board of directors.

The provisions of the stockholders’ agreement relating to Invus’ rights to designate members of our board of directors and its audit, compensation and corporate governance committees will terminate if the percentage of all the outstanding shares of our common stock owned by Invus and its affiliates falls below 10%. Invus also has the right to terminate these provisions at any time in its discretion.

Invus has preemptive rights under the stockholders’ agreement to participate in future equity issuances by us, subject to certain exceptions, so as to maintain its then-current percentage ownership of our capital stock. Subject to certain limitations, Invus will be required to exercise its preemptive rights in advance with respect to certain marketed offerings, in which case it will be obligated to buy its pro rata share of the number of shares being offered in such marketed offering, including any overallotment (or such lesser amount specified in its exercise of such rights), so long as the sale of the shares were priced within a range within 10% above or below the market price on the date we notified Invus of the offering and we met certain other conditions.
The provisions of the stockholders’ agreement relating to preemptive rights will terminate on the earlier to occur of August 28, 2017 and the date on which the percentage of all the outstanding shares of our common stock owned by Invus and its affiliates falls below 10%.
Invus is entitled to certain consent rights under the stockholders’ agreement, including with respect to (a) the creation or issuance of any new class or series of shares of our capital stock (or securities convertible into or exercisable for shares of our capital stock) having rights, preferences or privileges senior to or on parity with our common stock, (b) any amendment to our certificate of incorporation or bylaws, or amendment to the certificate of incorporation or bylaws of any of our subsidiaries, in a manner adversely affecting Invus’ rights under the securities purchase agreement and the related agreements, (c) the repurchase, retirement, redemption or other acquisition of our or our subsidiaries’ capital stock (or securities convertible into or exercisable for shares of our or our subsidiaries’ capital stock), (d) any increase in the size of our board of directors to more than 12 members and (e) the adoption or proposed adoption of any stockholders’ rights plan, “poison pill” or other similar plan or agreement, unless Invus is exempt from the provisions of such plan or agreement.
The provisions of the stockholders’ agreement relating to those consent rights will terminate on the earlier to occur of August 28, 2017 and the date on which Invus and its affiliates hold less than 15% of the total number of outstanding shares of our common stock.
Our stock price may be extremely volatile.
 
The trading price of our common stock has been highly volatile, and we believe the trading price of our common stock will remain highly volatile and may fluctuate substantially due to factors such as the following:
 
adverse results or delays in clinical trials;
announcement of FDA approval or non-approval, or delays in the FDA review process, of our or our collaborators’ product candidates or those of our competitors or actions taken by regulatory agencies with respect to our, our collaborators’ or our competitors’ clinical trials;

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the announcement of new products by us or our competitors;
quarterly variations in our or our competitors’ results of operations;
conflicts or litigation with our collaborators;
litigation, including intellectual property infringement and product liability lawsuits, involving us;
failure to achieve operating results projected by securities analysts;
changes in earnings estimates or recommendations by securities analysts;
financing transactions;
developments in the biotechnology or pharmaceutical industry;
sales of large blocks of our common stock or sales of our common stock by our executive officers, directors and significant stockholders;
departures of key personnel or board members;
developments concerning current or future collaborations;
FDA or international regulatory actions;
third-party reimbursement policies;
acquisitions of other companies or technologies;
disposition of any of our subsidiaries, drug programs or other technologies; and
other factors, including factors unrelated to our operating performance or the operating performance of our competitors.
These factors, as well as general economic, political and market conditions, may materially adversely affect the market price of our common stock.
 
In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted.  A securities class action suit against us could result in substantial costs and divert management’s attention and resources, which could have a material and adverse effect on our business.
 
We may engage in future acquisitions, which may be expensive and time consuming and from which we may not realize anticipated benefits.
 
We may acquire additional businesses, technologies and products if we determine that these businesses, technologies and products complement our existing technology or otherwise serve our strategic goals.  If we do undertake any transactions of this sort, the process of integrating an acquired business, technology or product may result in operating difficulties and expenditures and may not be achieved in a timely and non-disruptive manner, if at all, and may absorb significant management attention that would otherwise be available for ongoing development of our business.  If we fail to integrate acquired businesses, technologies or products effectively or if key employees of an acquired business leave, the anticipated benefits of the acquisition would be jeopardized.  Moreover, we may never realize the anticipated benefits of any acquisition, such as increased revenues and earnings or enhanced business synergies.  Future acquisitions could result in potentially dilutive issuances of our equity securities, the incurrence of debt and contingent liabilities and amortization expenses related to intangible assets, which could materially impair our results of operations and financial condition.
 
Future sales of our common stock may depress our stock price.
 
If our stockholders sell substantial amounts of our common stock (including shares issued upon the exercise of options) in the public market, the market price of our common stock could fall.  These sales also might make it more difficult for us to sell equity or equity-related securities in the future at a time and price that we deem appropriate.  For example,

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following an acquisition, a significant number of shares of our common stock held by new stockholders may become freely tradable or holders of registration rights could cause us to register their shares for resale.  Sales of these shares of common stock held by existing stockholders could cause the market price of our common stock to decline.

If we are unable to meet Nasdaq continued listing requirements, Nasdaq may take action to delist our common stock.
 
Our common stock trades on The Nasdaq Global Select Market, which has qualitative and quantitative listing criteria, including operating results, net assets, corporate governance, minimum trading price and minimums for public float, which is the amount of stock not held by our affiliates.  If we are unable to meet Nasdaq continued listing requirements, Nasdaq may take action to delist our common stock. A delisting of our common stock could negatively impact us and our shareholders by reducing the liquidity and market price of our common stock and potentially reducing the number of investors willing to hold or acquire our common stock.
 
Item 1B. Unresolved Staff Comments
 
None.
 
Item 2.  Properties
 
We currently own approximately 260,000 square feet of space for our corporate offices and laboratories in buildings located in The Woodlands, Texas, a suburb of Houston, Texas, and lease approximately 25,000 square feet of office space in Basking Ridge, New Jersey.
 
In April 2004, we obtained a $34.0 million mortgage on our facilities in The Woodlands, Texas.  The mortgage loan originally had a ten-year term with a 20-year amortization and a fixed rate of 8.23%. The mortgage was amended in September 2013 to extend the maturity date from April 2014 to April 2017, with the mortgage loan’s monthly payment amount and fixed interest rate each remaining unchanged.  The mortgage had a principal balance outstanding of $18.3 million as of December 31, 2015. In January 2016, we agreed to sell our facilities in The Woodlands, Texas for a purchase price of $21.2 million, subject to normal and customary closing conditions and the negotiation and execution of a leaseback agreement with respect to a portion of the facilities.
 
In March 2015, our subsidiary Lexicon Pharmaceuticals (New Jersey), Inc. leased a 25,000 square-foot office space in Basking Ridge, New Jersey. The term of the lease extends from June 1, 2015 through December 31, 2022, and provides for escalating yearly base rent payments starting at $482,000 and increasing to $646,000 in the final year of the lease.  We are the guarantor of the obligations of our subsidiary under the lease.
 
We believe that our facilities are well-maintained, in good operating condition and acceptable for our current operations.
 
Item 3.  Legal Proceedings
 
We are from time to time party to claims and legal proceedings that arise in the normal course of our business and that we believe will not have, individually or in the aggregate, a material adverse effect on our results of operations, financial condition or liquidity.
 
Item 4. Mine Safety Disclosures
 
Not applicable.

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PART II
 
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Our common stock is quoted on The Nasdaq Global Select Market under the symbol “LXRX.”  The following table sets forth, for the periods indicated, the high and low sales prices for our common stock as reported on The Nasdaq Global Select Market.
 
High
 
Low
2014
 
 
 
First Quarter
$
14.42

 
$
11.34

Second Quarter
$
13.02

 
$
8.75

Third Quarter
$
12.46

 
$
8.96

Fourth Quarter
$
10.57

 
$
5.60

2015
 

 


First Quarter
$
8.54

 
$
6.09

Second Quarter
$
8.49

 
$
6.30

Third Quarter
$
15.79

 
$
7.85

Fourth Quarter
$
14.50

 
$
9.22


As of February 29, 2016, there were approximately 227 holders of record of our common stock.
 
We have never paid cash dividends on our common stock. We anticipate that we will retain all of our future earnings, if any, for use in the expansion and operation of our business and do not anticipate paying cash dividends in the foreseeable future.
 
Performance Graph
 
The following performance graph compares the performance of our common stock to the Nasdaq Composite Index and the Nasdaq Biotechnology Index for the period beginning December 31, 2010 and ending December 31, 2015. The graph assumes that the value of the investment in our common stock and each index was $100 at December 31, 2010, and that all dividends were reinvested.





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December 31,
 
2010
 
2011
 
2012
 
2013
 
2014
 
2015
Lexicon Pharmaceuticals, Inc.
100
 
90
 
153
 
125
 
63
 
132
Nasdaq Composite Index
100
 
98
 
114
 
157
 
179
 
189
Nasdaq Biotechnology Index
100
 
112
 
147
 
244
 
328
 
365
The foregoing stock price performance comparisons shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference by any general statement incorporating by reference this annual report on Form 10-K into any filing under the Securities Act of 1933 or under the Securities Exchange Act of 1934, except to the extent that we specifically incorporate such comparisons by reference.


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Item 6. Selected Financial Data
 
The statements of comprehensive loss data for the years ended December 31, 2015, 2014 and 2013 and the balance sheet data as of December 31, 2015 and 2014 have been derived from our audited financial statements included elsewhere in this annual report on Form 10-K.  The statements of comprehensive loss data for the years ended December 31, 2012 and 2011, and the balance sheet data as of December 31, 2013, 2012 and 2011 have been derived from our audited financial statements not included in this annual report on Form 10-K.  Our historical results are not necessarily indicative of results to be expected for any future period.  The data presented below has been derived from financial statements that have been prepared in accordance with accounting principles generally accepted in the United States and should be read with our financial statements, including the notes, and with “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this annual report on Form 10-K.
 
Year Ended December 31,
 
2015
 
2014
 
2013
 
2012
 
2011
Statements of Comprehensive Loss Data:
 
 
(in thousands, except per share data)
 
 
Revenues                                                       
$
130,014

 
$
22,854

 
$
2,222

 
$
1,089

 
$
1,849

Operating expenses:
 
 
 
 
 
 
 
 
 
Research and development, including stock-based compensation of $3,693 in 2015, $4,020 in 2014, $4,376 in 2013, $3,673 in 2012 and $3,249 in 2011
95,187

 
89,279

 
89,682

 
82,574

 
91,828

Increase (decrease) in fair value of Symphony Icon, Inc. purchase liability
5,927

 
1,428

 
(2,210
)
 
9,887

 
6,766

General and administrative, including stock-based compensation of $3,150 in 2015, $3,061 in 2014, $3,045 in 2013, $2,822 in 2012 and $2,458 in 2011
23,835

 
19,411

 
17,121

 
17,043

 
17,350

Impairment loss on buildings
3,597

 
13,102

 

 

 

Total operating expenses
128,546

 
123,220

 
104,593

 
109,504

 
115,944

Income (loss) from operations
1,468

 
(100,366
)
 
(102,371
)
 
(108,415
)
 
(114,095
)
Interest and other income (expense), net
(6,150
)
 
2

 
(1,755
)
 
(1,796
)
 
(2,120
)
Consolidated net loss before taxes
(4,682
)
 
(100,364
)
 
(104,126
)
 
(110,211
)
 
(116,215
)
Income tax benefit

 
70

 

 

 

Consolidated net loss
$
(4,682
)
 
$
(100,294
)
 
$
(104,126
)
 
$
(110,211
)
 
$
(116,215
)
Consolidated net loss per common share, basic and diluted
$
(0.05
)
 
$
(1.31
)
 
$
(1.42
)
 
$
(1.58
)
 
$
(2.39
)
Shares used in computing consolidated net loss per common share, basic and diluted
103,591

 
76,347

 
73,302

 
69,958

 
48,680


 
As of December 31,
 
2015
 
2014
 
2013
 
2012
 
2011
Balance Sheet Data:
 
 
(in thousands)
 
 
Cash, cash equivalents and short-term investments, including restricted cash and investments
$
521,352

 
$
339,339

 
$
129,128

 
$
223,208

 
$
281,692

Working capital
409,404

 
324,018

 
115,260

 
212,650

 
264,400

Total assets
654,832

 
471,376

 
274,160

 
371,778

 
430,512

Long-term debt, net of current portion
103,793

 
87,500

 
20,167

 
21,877

 
23,451

Accumulated deficit
(1,108,934
)
 
(1,104,252
)
 
(1,003,958
)
 
(899,832
)
 
(789,621
)
Lexicon Pharmaceuticals, Inc. stockholders’ equity
285,850

 
284,018

 
170,163

 
266,678

 
297,568




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Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
 
The following discussion and analysis should be read with “Selected Financial Data” and our financial statements and notes included elsewhere in this annual report on Form 10-K.
 
Overview
 
We are a biopharmaceutical company focused on the development of breakthrough treatments for human disease.  We have advanced multiple drug candidates into clinical development and are presently devoting most of our resources to the development of our two most advanced drug candidates:

We are developing telotristat etiprate, or LX1032, an orally-delivered small molecule drug candidate, as a treatment for carcinoid syndrome. We have reported positive top-line data from both our pivotal TELESTAR Phase 3 clinical trial and its companion TELECAST Phase 3 clinical trial of telotristat etiprate in carcinoid syndrome patients. We are presently preparing an application for regulatory approval to market telotristat etiprate in the United States and, if approved, for the commercial launch of telotristat etiprate in the United States. We have granted Ipsen Pharma SAS an exclusive, royalty-bearing right to commercialize telotristat etiprate outside of the United States and Japan.
We are developing sotagliflozin, or LX4211, an orally-delivered small molecule drug candidate, as a treatment for type 1 and type 2 diabetes. We have reported positive data from a Phase 2 clinical trial of sotagliflozin in type 1 diabetes patients and two additional Phase 2 clinical trials of sotagliflozin in type 2 diabetes patients. We have granted Sanofi an exclusive, worldwide, royalty-bearing right to develop, manufacture and commercialize sotagliflozin. We are presently conducting Phase 3 development of sotagliflozin for type 1 diabetes and preparing with Sanofi for Phase 3 development of sotagliflozin in type 2 diabetes.
Our most advanced drug candidates, as well as compounds from a number of additional drug discovery and development programs that we have advanced into various stages of clinical and preclinical development, originated from our own internal drug discovery efforts. These efforts were driven by a systematic, target biology-driven approach in which we used gene knockout technologies and an integrated platform of advanced medical technologies to systematically study the physiological and behavioral functions of almost 5,000 genes in mice and assessed the utility of the proteins encoded by the corresponding human genes as potential drug targets. We have identified and validated in living animals, or in vivo, more than 100 targets with promising profiles for drug discovery.

We are working both independently and through strategic collaborations and alliances with third parties to capitalize on our drug target discoveries and drug discovery and development programs. We seek to retain exclusive or co-exclusive rights to the benefits of certain drug discovery and development programs by developing and commercializing drug candidates from those programs internally, particularly in the United States for indications treated by specialist physicians. We seek to collaborate with other pharmaceutical and biotechnology companies, such as Ipsen, Sanofi and Bristol-Myers Squibb, with respect to drug discovery or the development and commercialization of certain of our drug candidates, particularly with respect to commercialization in territories outside the United States, commercialization in the United States for indications treated by primary care physicians, or when the collaboration may otherwise provide us with access to expertise and resources that we do not possess internally or are complementary to our own.

We have derived substantially all of our revenues from strategic collaborations and other research and development collaborations and technology licenses. To date, we have generated a substantial portion of our revenues from a limited number of sources.
 
Our operating results and, in particular, our ability to generate additional revenues are dependent on many factors, including our success in obtaining regulatory approval for the marketing and sale of telotristat etiprate in the United States; if approved, our ability to successfully commercialize telotristat etiprate in the United States; the amount and timing of payments, if any, under our existing collaboration agreements with Sanofi, Ipsen and other entities; the success of our ongoing preclinical and clinical development efforts; our success in establishing new collaborations and licenses; the timing and willingness of such new collaborators to commercialize products that would result in milestone payments and royalties and their success in such efforts; and general and industry-specific economic conditions which may affect research and development expenditures.  Future revenues from our existing collaborations are uncertain because they depend, to a large degree, on the achievement of milestones and payment of royalties we earn from any future products developed under the collaborations. Our ability to secure future revenue-generating agreements will depend upon our ability to address the needs of our potential future collaborators and licensees, and to negotiate agreements that we believe are in our long-term best interests.  We may determine, as we have with certain of our drug candidates, including telotristat etiprate in the United States and Japan, that our interests are

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better served by retaining rights to our discoveries and advancing our therapeutic programs to a later stage, which could limit our near-term revenues and increase expenses.  Because of these and other factors, our operating results have fluctuated in the past and are likely to do so in the future, and we do not believe that period-to-period comparisons of our operating results are a good indication of our future performance.
 
Since our inception, we have incurred significant losses and, as of December 31, 2015, we had an accumulated deficit of $1.1 billion. Our losses have resulted principally from costs incurred in research and development, general and administrative costs associated with our operations, and non-cash stock-based compensation expenses associated with stock options and restricted stock granted to employees and consultants.  Research and development expenses consist primarily of salaries and related personnel costs, external research costs related to our nonclinical and clinical efforts, material costs, facility costs, depreciation on property and equipment, and other expenses related to our drug discovery and development programs. General and administrative expenses consist primarily of salaries and related expenses for executive and administrative personnel, professional fees and other corporate expenses, including information technology, facilities costs and general legal activities.  We expect to continue to incur significant research and development costs in connection with the continuing development of our drug candidates. As a result, we will need to generate significantly higher revenues to achieve profitability.

Critical Accounting Policies
 
Revenue Recognition
 
We recognize revenues when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable, and collectibility is reasonably assured.

Collaborative agreements revenues include both license revenue and contract research revenue. Activities under collaborative agreements are evaluated to determine if they represent a multiple element revenue agreement. The Company identifies the deliverables included within the agreement and evaluates which deliverables represent separate units of accounting. The Company accounts for those components as separate units of accounting if the following two criteria are met:

The delivered item or items have value to the customer on a stand-alone basis.
If there is a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and within the Company’s control.

Factors considered in this determination include, among other things, whether any other vendors sell the items separately and if the licensee could use the delivered item for its intended purpose without the receipt of the remaining deliverables. If multiple deliverables included in an arrangement are separable into different units of accounting, the Company allocates the arrangement consideration to those units of accounting. The amount of allocable arrangement consideration is limited to amounts that are fixed or determinable. Arrangement consideration is allocated at the inception of the arrangement to the identified units of accounting based on their relative estimated selling price. Revenue is recognized for each unit of accounting when the appropriate revenue recognition criteria are met.

Future milestone payments that are contingent upon the achievement of a substantive milestone are recognized in their entirety in the period in which the milestone is achieved. A milestone is substantive if:

It can only be achieved based in whole or in part on either the Company’s performance or on the occurrence of a specific outcome resulting from the Company’s performance;
There is substantive uncertainty at the date an arrangement is entered into that the event will be achieved; and
It would result in additional payments being due to the Company.

Subscription and license fees are recognized as revenue upon the grant of the technology license when performance is complete and there is no continuing involvement. Royalty revenues are recognized as earned in accordance with the contract terms at the time the royalty amount is fixed and determinable based on information received from the sublicensees and at the time collectibility is reasonably assured.
 
A change in our revenue recognition policy or changes in the terms of contracts under which we recognize revenues could have an impact on the amount and timing of our recognition of revenues.
 

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Research and Development Expenses
 
Research and development expenses consist of costs incurred for research and development activities solely sponsored by us as well as collaborative research and development activities.  These costs include direct and research-related overhead expenses and are expensed as incurred.  Technology license fees for technologies that are utilized in research and development and have no alternative future use are expensed when incurred.
 
We have advanced multiple drug candidates into clinical development. We are presently devoting most of our resources to the development of our two most advanced drug candidates:
Telotristat etiprate, an orally-delivered small molecule drug candidate that we are developing as a treatment for carcinoid syndrome; and
Sotagliflozin, an orally-delivered small molecule drug candidate that we are developing as a treatment for type 1 and type 2 diabetes.
Our most advanced drug candidates, as well as compounds from a number of additional drug discovery and development programs that we have advanced into various stages of clinical and preclinical development, originated from our own internal drug discovery efforts. These efforts were driven by a systematic, target biology-driven approach in which we used gene knockout technologies and an integrated platform of advanced medical technologies to systematically study the physiological and behavioral functions of almost 5,000 genes in mice and assessed the utility of the proteins encoded by the corresponding human genes as potential drug targets. We have identified and validated in living animals, or in vivo, more than 100 targets with promising profiles for drug discovery.

The drug development process takes many years to complete.  The cost and length of time varies due to many factors including the type, complexity and intended use of the drug candidate.  We estimate that drug development activities are typically completed over the following periods:
Phase
 
Estimated Completion Period
Preclinical development
 
1-2 years
Phase 1 clinical trials
 
1-2 years
Phase 2 clinical trials
 
1-2 years
Phase 3 clinical trials
 
2-4 years
 
We expect research and development costs to increase in the future as later stage clinical trials for telotristat etiprate and sotagliflozin continue to enroll and new drug candidates enter clinical development.  Due to the variability in the length of time necessary for drug development, the uncertainties related to the cost of these activities and ultimate ability to obtain governmental approval for commercialization, accurate and meaningful estimates of the ultimate costs to bring our potential drug candidates to market are not available.
 
We record significant accrued liabilities related to unbilled expenses for products or services that we have received from service providers, specifically related to ongoing nonclinical studies and clinical trials.  These costs primarily relate to clinical study management, monitoring, laboratory and analysis costs, drug supplies, toxicology studies and investigator grants.  We have multiple drugs in concurrent nonclinical studies and clinical trials at clinical sites throughout the world.  In order to ensure that we have adequately provided for ongoing nonclinical and clinical development costs during the period in which we incur such costs, we maintain accruals to cover these expenses.  Substantial portions of our nonclinical studies and clinical trials are performed by third-party laboratories, medical centers, contract research organizations and other vendors. For nonclinical studies, we accrue expenses based upon estimated percentage of work completed and the contract milestones remaining. For clinical studies, expenses are accrued based upon the number of patients enrolled and the duration of the study. We monitor patient enrollment, the progress of clinical studies and related activities to the extent possible through internal reviews of data reported to us by the vendors and clinical site visits. Our estimates depend on the timeliness and accuracy of the data provided by our vendors regarding the status of each program and total program spending. We periodically evaluate the estimates to determine if adjustments are necessary or appropriate based on information we receive.  Although we use consistent milestones or subject or patient enrollment to drive expense recognition, the assessment of these costs is a subjective process that requires judgment.  Upon settlement, these costs may differ materially from the amounts accrued in our consolidated financial statements.
 
We record our research and development costs by type or category, rather than by project.  Significant categories of costs include personnel, facilities and equipment costs and third-party and other services.  In addition, a significant portion of

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our research and development expenses is not tracked by project as it benefits multiple projects. Consequently, fully-loaded research and development cost summaries by project are not available.
 
Stock-based Compensation Expense
 
We recognize compensation expense in our statements of comprehensive loss for share-based payments, including stock options issued to employees, based on their fair values on the date of the grant, with the compensation expense recognized over the period in which an employee is required to provide service in exchange for the stock award.  Stock-based compensation expense for awards without performance conditions is recognized on a straight-line basis. Stock-based compensation expense for awards with performance conditions is recognized over the period from the date the performance condition is determined to be probable of occurring through the time the applicable condition is met.  We had stock-based compensation expense of $6.8 million for the year ended December 31, 2015, or $0.07 per share.  As of December 31, 2015, stock-based compensation cost for all outstanding unvested options and restricted stock units was $10.5 million, which is expected to be recognized over a weighted-average vesting period of 1.3 years.
 
The fair value of stock options is estimated at the date of grant using the Black-Scholes option-pricing model.  For purposes of determining the fair value of stock options, we segregate our options into two homogeneous groups, based on exercise and post-vesting employment termination behaviors, resulting in a change in the assumptions used for expected option lives and forfeitures.  Expected volatility is based on the historical volatility in our stock price.  The following weighted-average assumptions were used for options granted in the years ended December 31, 2015, 2014 and 2013, respectively:
 
Expected Volatility
 
Risk-free Interest Rate
 
Expected Term
 
Dividend
Rate
December 31, 2015:
 
 
 
 
 
 
 
Employees
64
%
 
1.2
%
 
4
 
0
%
Officers and non-employee directors
81
%
 
1.8
%
 
8
 
0
%
December 31, 2014:

 

 

 

Employees
66
%
 
1.2
%
 
4
 
0
%
Officers and non-employee directors
80
%
 
2.3
%
 
8
 
0
%
December 31, 2013:

 

 

 

Employees
85
%
 
0.9
%
 
5
 
0
%
Officers and non-employee directors
81
%
 
1.6
%
 
8
 
0
%

Impairment of Long-Lived Assets
 
Our long-lived assets include property, plant and equipment, intangible assets and goodwill. We regularly review long-lived assets for impairment. The recoverability of long-lived assets, other than goodwill, is measured by comparing the assets carrying amount to the expected undiscounted future cash flows that the asset is expected to generate. Determining whether an impairment has occurred typically requires various estimates and assumptions, including determining which cash flows are directly related to the potentially impaired asset, the useful life over which cash flows will occur, their amount, and the asset's residual value, if any. We use internal cash flow estimates, quoted market prices when available and independent appraisals as appropriate to determine fair value. We derive the required cash flow estimates from our historical experience and our internal business plans and apply an appropriate discount rate.

Indefinite-lived intangible assets, composed primarily of in-process research and development (“IPR&D”) projects acquired in business combinations which have not reached technological feasibility, are reviewed annually for impairment and whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. Estimating future cash flows of an IPR&D product candidate for purposes of an impairment analysis requires us to make significant estimates and assumptions regarding the amount and timing of costs to complete the project and the amount, timing and probability of achieving revenues from the completed product similar to how the acquisition date fair value of the project was determined.

During the year ended December 31, 2014, we reclassified our buildings and land to assets held for sale, as we intended to sell these assets. In the fourth quarter of the year ended December 31, 2015, we made a change to our plan of sale and reclassified our buildings and land as assets held and used in accordance with the accounting guidance regarding selling assets with a leaseback requirement. We estimated the fair value of the net assets to be sold at approximately $20.3 million and $23.8 million as of December 31, 2015 and 2014, respectively, which represents estimated selling price less costs to sell. This resulted in impairment losses on the buildings of $3.6 million and $13.1 million in the years ended December 31, 2015 and

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2014, respectively, which were recorded in impairment loss on buildings in the accompanying consolidated statements of comprehensive loss (see Note 6, Buildings and Land for Sale, of the Notes to Consolidated Financial Statements, for more information). There were no significant impairments of long-lived assets in 2013.

Goodwill is not amortized, but is tested at least annually for impairment at the reporting unit level.  We have determined that the reporting unit is the single operating segment disclosed in our current financial statements.  Impairment is the condition that exists when the carrying amount of goodwill exceeds its implied fair value.  The first step in the impairment process is to determine the fair value of the reporting unit and then compare it to the carrying value, including goodwill.  We determined that the market capitalization approach is the most appropriate method of measuring fair value of the reporting unit.  Under this approach, fair value is calculated as the average closing price of our common stock for the 30 days preceding the date that the annual impairment test is performed, multiplied by the number of outstanding shares on that date.  A control premium, which is representative of premiums paid in the marketplace to acquire a controlling interest in a company, is then added to the market capitalization to determine the fair value of the reporting unit.  If the fair value exceeds the carrying value, no further action is required and no impairment loss is recognized.  Additional impairment assessments may be performed on an interim basis if we encounter events or changes in circumstances that would indicate that, more likely than not, the carrying value of goodwill has been impaired.  There was no impairment of goodwill in 2015, 2014 and 2013.

Business Combinations

We allocate the purchase price of acquired businesses to the tangible and intangible assets acquired and liabilities assumed based upon their estimated fair values on the acquisition date. The purchase price allocation process requires management to make significant estimates and assumptions, especially at acquisition date with respect to intangible assets and in-process research and development.

These assumptions are based in part on historical experience and are inherently uncertain. Examples of critical estimates in valuing certain of the intangible assets we have acquired or may acquire in the future include but are not limited to: the feasibility and timing of achievement of development, regulatory and commercial milestones; expected costs to develop the in-process research and development into commercially viable products; and future expected cash flows from product sales.

In connection with the purchase price allocations for acquisitions, we estimate the fair value of the contingent payments. The estimated fair value of any contingent payments is determined utilizing a probability-based income approach inclusive of an estimated discount rate.

Unanticipated events and circumstances may occur which may affect the accuracy or validity of such assumptions, estimates or actual results.
 
Recent Accounting Pronouncements
 
See Note 3, Recent Accounting Pronouncements, of the Notes to Consolidated Financial Statements, for a discussion of the impact of new accounting standards on our consolidated financial statements.
 
Results of Operations – Comparison of Years Ended December 31, 2015, 2014 and 2013
 
Revenues
 
Total revenues and dollar and percentage changes as compared to the prior year are as follows (dollar amounts are presented in millions):
 
Year Ended December 31,
 
2015
 
2014
 
2013
Total revenues                                              
$
130.0

 
$
22.9

 
$
2.2

Dollar increase                                
$
107.2

 
$
20.6

 
 
Percentage increase                         
469
%
 
929
%
 
 
 

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Years Ended December 31, 2015 and 2014
 
Collaborative agreements – Revenue from collaborative agreements increased 474% to $129.7 million, primarily due to revenues recognized from the collaboration and license agreement with Sanofi.
 
Subscription and license fees – Revenues from subscriptions and license fees increased 10% to $0.3 million.
 
Years Ended December 31, 2014 and 2013 

Collaborative agreements – Revenue from collaborative agreements increased 971% to $22.6 million, primarily due to revenues recognized from the license and collaboration agreement with Ipsen Pharma SAS.
 
Subscription and license fees – Revenue from subscriptions and license fees decreased 131% to $0.3 million, primarily due to increases in technology license fees.

In 2015, Sanofi represented 98% of revenues. In 2014, Ipsen Pharma SAS represented 94% of revenues. In 2013, McNair Medical Institute, LLC and Taconic Farms, Inc. represented 57% and 33% of revenues, respectively.
 
Research and Development Expenses
 
Research and development expenses and dollar and percentage changes as compared to the prior year are as follows (dollar amounts are presented in millions):
 
Year Ended December 31,
 
2015
 
2014
 
2013
Total research and development expense
$
95.2

 
$
89.3

 
$
89.7

Dollar increase (decrease)
$
5.9

 
$
(0.4
)
 
 

Percentage increase (decrease)
7
%
 
 %
 
 

 
Research and development expenses consist primarily of third-party and other services principally related to nonclinical and clinical development activities, salaries and other personnel-related expenses, facility and equipment costs, stock-based compensation.
 
Years Ended December 31, 2015 and 2014
 
Third-party and other services – Third-party and other services increased 37% in 2015 to $69.9 million, primarily due to increases in our external clinical and nonclinical research and development costs. Third-party and other services relate principally to our clinical trial and related development activities, such as nonclinical and clinical studies and contract manufacturing.

Personnel – Personnel costs decreased 35% in 2015 to $14.8 million, primarily due to reductions in our personnel in 2014. Salaries, bonuses, employee benefits, payroll taxes, recruiting and relocation costs are included in personnel costs.
 
Facilities and equipment – Facilities and equipment costs decreased 54% in 2015 to $3.1 million, primarily due to reductions in depreciation and rent expense.
 
Stock-based compensation – Stock-based compensation expense decreased 8% in 2015 to $3.7 million.
 
Other – Other costs decreased 23% to $3.7 million.
 
Years Ended December 31, 2014 and 2013
 
Third-party and other services – Third-party and other services increased 22% in 2014 to $51.0 million, primarily due to increases in our external clinical and nonclinical research and development costs.


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Personnel – Personnel costs decreased 13% in 2014 to $22.6 million, primarily due to reductions in our personnel in 2014, partially offset by increased severance costs as a result of those reductions.
 
Facilities and equipment – Facilities and equipment costs decreased 22% in 2014 to $6.8 million, primarily due to reductions in laboratory equipment costs and reductions in depreciation expense.
 
Stock-based compensation – Stock-based compensation expense decreased 8% in 2014 to $4.0 million.
 
Other – Other costs decreased 45% to $4.8 million.
 
Increase (Decrease) in Fair Value of Symphony Icon Liability

The fair value of the Symphony Icon purchase liability increased by $5.9 million in the year ended December 31, 2015, increased by $1.4 million in the year ended December 31, 2014, and decreased by $2.2 million for the year ended December 31, 2013, respectively (see Note 11, Arrangements with Symphony Icon, Inc., of the Notes to Consolidated Financial Statements, for more information). The decrease in 2013 was primarily attributable to a reduction in the liability associated with our LX1033 development program in diarrhea-predominant irritable bowel syndrome.

General and Administrative Expenses
 
General and administrative expenses and dollar and percentage changes as compared to the prior year are as follows (dollar amounts are presented in millions):
 
Year Ended December 31,
 
2015
 
2014
 
2013
Total general and administrative expense
$
23.8

 
$
19.4

 
$
17.1

Dollar increase
$
4.4

 
$
2.3

 
 

Percentage increase
23
%
 
13
%
 
 

 
General and administrative expenses consist primarily of personnel costs to support our research and development activities, professional and consulting fees, stock-based compensation expense, and facility and equipment costs.
 
Years Ended December 31, 2015 and 2014

Personnel – Personnel costs increased 8% in 2015 to $10.3 million. Salaries, bonuses, employee benefits, payroll taxes, recruiting and relocation costs are included in personnel costs.

Professional and consulting fees – Professional and consulting fees increased 91% in 2015 to $7.4 million, primarily due to increased consulting costs in preparation for commercialization of telotristat etiprate.
 
Stock-based compensation – Stock-based compensation expense was $3.1 million in 2015, consistent with the prior year.
 
Facilities and equipment – Facilities and equipment costs decreased 37% in 2015 to $1.0 million.
  
Other – Other costs increased 46% in 2015 to $2.0 million.
 
Years Ended December 31, 2014 and 2013

Personnel – Personnel costs increased 24% in 2014 to $9.5 million, primarily due to increased severance costs as a result of reductions in personnel in 2014.

Professional and consulting fees – Professional and consulting fees increased 19% in 2014 to $3.9 million, primarily due to increased consulting costs in preparation for commercialization of telotristat etiprate.
 
Stock-based compensation – Stock-based compensation expense increased 1% in 2014 to $3.1 million.
 
Facilities and equipment – Facilities and equipment costs decreased 10% in 2014 to $1.5 million.

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Other – Other costs in 2014 were $1.4 million, consistent with the prior year.

Impairment Loss on Buildings

In 2014, Lexicon reclassified its buildings and land to assets held for sale on its consolidated balance sheets, as it intended to sell these assets. In the fourth quarter of 2015, Lexicon made a change to its plan of sale and reclassified these assets as assets held and used in accordance with the accounting guidance regarding selling assets with a leaseback requirement. The Company recognized impairment losses on its buildings of $3.6 million and $13.1 million for the years ended December 31, 2015 and 2014, respectively, as a result of writing down the buildings to the estimated net selling price (see Note 6, Buildings and Land for Sale, of the Notes to Consolidated Financial Statements, for more information).

Interest Expense and Interest and Other Income (Expense), Net
   
Interest Expense.  Interest expense increased 198% in 2015 to $6.7 million from $2.3 million in 2014 and increased 14% in 2014 from $2.0 million in 2013. The increase in 2015 was primarily due to the Convertible Senior Notes issued by the Company in November 2014 (see Note 10, Debt Obligations, of the Notes to Consolidated Financial Statements, for more information).
 
Interest and Other Income (Expense), Net.  Interest and other income, net was $0.6 million, $2.3 million, and $0.2 million in the years ended December 31, 2015, 2014, and 2013, respectively.  The increase in interest and other income in 2014 was primarily due to gains from sales of excess property and equipment.

Income Tax Benefit
The income tax benefit for the years ended December 31, 2015, 2014, and 2013 was $0, $70,000 and $0, respectively.
Consolidated Net Loss and Consolidated Net Loss per Common Share
Consolidated net loss decreased to $4.7 million in 2015 from $100.3 million in 2014 and $104.1 million in 2013.  Net loss per common share was $0.05 in 2015, $1.31 in 2014, and $1.42 in 2013.
 
Liquidity and Capital Resources
 
We have financed our operations from inception primarily through sales of common and preferred stock, contract and milestone payments to us under our strategic and other collaborations, target validation, database subscription and technology license agreements, government grants and contracts and financing under debt and lease arrangements.  We have also financed certain of our research and development activities under our agreements with Symphony Icon, Inc.  From our inception through December 31, 2015, we had received net proceeds of $1.3 billion from issuances of common and preferred stock.  In addition, from our inception through December 31, 2015, we received $782.6 million in cash payments from strategic and other collaborations, target validation, database subscription and technology license agreements, sales of compound libraries and reagents and government grants and contracts, of which $597.6 million had been recognized as revenues through December 31, 2015.
 
As of December 31, 2015, we had $521.4 million in cash, cash equivalents and investments.  As of December 31, 2014, we had $339.3 million in cash, cash equivalents and short-term investments.  We generated cash of $184.8 million from operations in 2015. This consisted primarily of the increase in deferred revenue of $171.4 million and non-cash charges of $6.8 million related to stock-based compensation expense, $5.9 million related to the increase in fair value of the Symphony Icon purchase liability, impairment of assets of $3.6 million, a net decrease in other operating assets net of liabilities of $0.5 million and $0.7 million related to depreciation expense, partially offset by the consolidated net loss for the year of $4.7 million.  Investing activities used cash of $117.0 million in 2015, primarily due to net purchases of investments of $116.4 million.  Financing activities used cash of $2.0 million primarily due to repayment of debt borrowings of $1.9 million.
 
Symphony Drug Development Financing Agreements.  In June 2007, we entered into a series of related agreements providing for the financing of the clinical development of certain drug programs, including telotristat etiprate, along with any other pharmaceutical compositions modulating the same targets as those drug candidates.  Under the financing arrangement, we licensed to Symphony Icon, Inc., a then wholly-owned subsidiary of Symphony Icon Holdings LLC, our intellectual property rights related to the programs and Holdings contributed $45 million to Symphony Icon in order to fund the clinical

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development of the programs.  We also issued and sold to Holdings shares of our common stock in exchange for $15 million and received an exclusive option to acquire all of the equity of Symphony Icon, thereby allowing us to reacquire the programs.   

Upon the recommendation of Symphony Icon’s development committee, which was comprised of an equal number of representatives from us and Symphony Icon, Symphony Icon’s board of directors had the right to require us to pay Symphony Icon up to $15 million for Symphony Icon’s use in the development of the programs in accordance with a specified development plan and related development budget.  Symphony Icon’s board of directors requested that we pay Symphony Icon $9.3 million under the agreement, all of which was paid prior to the exercise of the purchase option in July 2010.
In July 2010, we entered into an amended and restated purchase option agreement with Symphony Icon and Holdings and simultaneously exercised our purchase option. Pursuant to the amended terms of the purchase option, we paid Holdings $10 million in July 2010 and issued 1,891,074 shares of common stock to designees of Holdings in July 2012 in satisfaction of an additional $35 million base payment obligation.
We also agreed to make up to $45 million in additional contingent payments, which will consist of 50% of any consideration we receive pursuant to any licensing transaction under which we grant a third party rights to commercialize telotristat etiprate or other pharmaceutical compositions modulating the same target as telotristat etiprate, which we refer to as the “LG103 programs,” subject to certain exceptions. The contingent payments will be due if and when we receive such consideration from such a licensing transaction. In the event we receive regulatory approval in the United States for the marketing and sale of any product resulting from the LG103 programs prior to entering into such a licensing transaction for the commercialization of such product in the United States, in lieu of any contingent payment from such a licensing transaction, we will pay Holdings the sum of $15 million and the amount of certain expenses we incurred after our exercise of the purchase option which are attributable to the development of such product, reduced by up to 50% of such sum for the amount of any contingent payments paid prior to such United States regulatory approval attributable to any such licensing transaction outside of the United States with respect to such product. In the event we make any such payment upon United States regulatory approval, we will have no obligation to make subsequent contingent payments attributable to any such licensing transactions for the commercialization of such product outside the United States until the proceeds of such licensing transactions exceed 50% of the payment made as a result of such United States regulatory approval.

The contingent payments may be paid in cash or a combination of cash and common stock, in our discretion, provided that no more than 50% of any contingent payment will be paid in common stock. On December 4, 2014, we paid $5.8 million in cash and issued 666,111 shares of common stock to designees of Holdings in satisfaction of a $11.5 million contingent payment obligation as a result of receiving an upfront payment pursuant to our license and collaboration agreement with Ipsen Pharma SAS. On April 24, 2015, we paid $0.75 million in cash to Holdings in satisfaction of our contingent payment obligation as a result of receiving an additional upfront payment from Ipsen in March 2015 (see Note 16, Collaboration and License Agreements, of the Notes to Consolidated Financial Statements, for more information).
Texas Institute for Genomic Medicine.  In July 2005, we received an award from the Texas Enterprise Fund for the creation of a knockout mouse embryonic stem cell library containing 350,000 cell lines for the Texas Institute for Genomic Medicine, or TIGM, using our proprietary gene trapping technology, which we completed in 2007.  We also equipped TIGM with the bioinformatics software required for the management and analysis of data relating to the library.  The Texas Enterprise Fund made an additional award to the Texas A&M University System for the creation of facilities and infrastructure to house the library.

Under the terms of our award, we are responsible for the creation of a specified number of jobs beginning in 2012, reaching an aggregate of 1,616 new jobs in Texas by December 31, 2016. We will receive credits against those job obligations based on funding received by TIGM and certain related parties from sources other than the State of Texas.  We will also receive credits against those jobs obligations for any surplus jobs we create. We may be required to repay the state a portion of the award if we fail to meet those job obligations. Subject to these credits, if we fail to create the specified number of jobs, the State may require us to repay $2,415 for each job we fall short beginning in 2013.  Our maximum aggregate exposure for such payments, if we fail to create any new jobs, is approximately $14.2 million, including $6.4 million through 2016, without giving effect to any credits to which we may be entitled.

Facilities.  In April 2004, we obtained a $34.0 million mortgage on our facilities in The Woodlands, Texas.  The mortgage loan originally had a ten-year term with a 20-year amortization and a fixed interest rate of 8.23%. The mortgage was amended in September 2013 to extend the maturity date from April 2014 to April 2017, with the mortgage loan’s monthly payment amount and fixed interest rate each remaining unchanged. The mortgage has a principal balance of $18.3 million as of December 31, 2015. In January 2016, we agreed to sell our facilities in The Woodlands, Texas for a purchase price of $21.2 million, subject to normal and customary closing conditions and the negotiation and execution of a leaseback agreement

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with respect to a portion of the facilities (see Note 6, Buildings and Land for Sale, of the Notes to Consolidated Financial Statements, for more information).

In March 2015, our subsidiary Lexicon Pharmaceuticals (New Jersey), Inc. leased a 25,000 square-foot office space in Basking Ridge, New Jersey. The term of the lease extends from June 1, 2015 through December 31, 2022, and provides for escalating yearly base rent payments starting at $482,000 and increasing to $646,000 in the final year of the lease.  We are the guarantor of the obligations of our subsidiary under the lease.
 
Including the lease and debt obligations described above, we had incurred the following contractual obligations as of December 31, 2015:
 
 
Payments due by period (in millions)
Contractual Obligations
Total
 
Less than 1 year
 
2-3 years
 
4-5 years
 
More than 5 years
Debt
$
105.8

 
$
2.0

 
$
16.3

 
$

 
$
87.5

Interest payment obligations
29.5

 
6.0

 
9.7

 
9.2

 
4.6

Operating leases
4.2

 
0.5

 
1.2

 
1.2

 
1.3

Total
$
139.5

 
$
8.5

 
$
27.2

 
$
10.4

 
$
93.4


The foregoing table does not include any potential payments related to the award we received from the Texas Enterprise Fund. Under the terms of the award, we are responsible for the creation of jobs beginning in 2012. Subject to credits, if we fail to create the specified number of jobs, the State of Texas may require us to repay $2,415 for each job we fall short beginning in 2013 and continuing until 2019. Our maximum aggregate exposure for such payment, if we fail to create any new jobs, is approximately $14.2 million, including $6.4 million through 2016, without giving effect to any credits to which we may be entitled. See Note 16, Collaboration and License Agreements, of the Notes to Consolidated Financial Statements, for further discussion.

Our future capital requirements will be substantial and will depend on many factors, including the amount and timing of payments, if any, under our existing collaboration agreements with Sanofi, Ipsen and other entities, our ability to establish new collaborations and licenses and the amount and timing of payments under such agreements, the level and timing of our research, development and commercialization expenditures, market acceptance of our products, the resources we devote to developing and supporting our products and other factors.  Our capital requirements will also be affected by any expenditures we make in connection with license agreements and acquisitions of and investments in complementary technologies and businesses.  We expect to devote substantial capital resources to seek regulatory approval for and, if approved, to commercialize our drug candidates, to continue and expand our development efforts, and for other general corporate activities.  We believe that our current unrestricted cash and investment balances and cash and revenues we expect to derive from strategic and other collaborations and other sources will be sufficient to fund our operations for at least the next 12 months.  During or after this period, if cash generated by operations is insufficient to satisfy our liquidity requirements, we will need to sell additional equity or debt securities or obtain additional credit arrangements.  Additional financing may not be available on terms acceptable to us or at all. The sale of additional equity or convertible debt securities may result in additional dilution to our stockholders.
 
Disclosure about Market Risk
 
We are exposed to limited market and credit risk on our cash equivalents which have maturities of three months or less at the time of purchase.  We maintain a short-term investment portfolio which consists of U.S. Treasury bills and corporate debt securities that mature three to 12 months from the time of purchase, which we believe are subject to limited market and credit risk.  We currently do not hedge interest rate exposure or hold any derivative financial instruments in our investment portfolio.
  
We had approximately $521.4 million in cash and cash equivalents and short-term investments as of December 31, 2015.  We believe that the working capital available to us will be sufficient to meet our cash requirements for at least the next 12 months.
 
We have operated primarily in the United States and substantially all sales to date have been made in U.S. dollars. Accordingly, we have not had any material exposure to foreign currency rate fluctuations.
 
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
 
See “Disclosure about Market Risk” under “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” for quantitative and qualitative disclosures about market risk.

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Item 8.  Financial Statements and Supplementary Data
 
The financial statements required by this Item are incorporated under Item 15 in Part IV of this report.
 
Item 9.  Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
 
None.
 
Item 9A.  Controls and Procedures
 
Our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures (as defined in rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) are effective to ensure that the information required to be disclosed by us in the reports we file under the Securities Exchange Act is gathered, analyzed and disclosed with adequate timeliness, accuracy and completeness, based on an evaluation of such controls and procedures as of the end of the period covered by this report.
 
Subsequent to our evaluation, there were no significant changes in internal controls or other factors that could significantly affect internal controls, including any corrective actions with regard to significant deficiencies and material weaknesses.

Management Report on Internal Control over Financial Reporting
 
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act).
 
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.  Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
 
Our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2015.  In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013 Framework).
 
Based on such assessment using those criteria, management believes that, as of December 31, 2015, our internal control over financial reporting is effective.
 
Our independent auditors have also audited our internal control over financial reporting as of December 31, 2015 as stated in the audit report which appears on page F-2 and is incorporated under Item 15 in Part IV of this report.
 
Item 9B.     Other Information
 
None.


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PART III
 
Item 10.  Directors, Executive Officers and Corporate Governance
 
The information required by this Item is hereby incorporated by reference from (a) the information appearing under the captions “Election of Directors,” “Stock Ownership of Certain Beneficial Owners and Management,” “Corporate Governance” and “Executive and Director Compensation” in our definitive proxy statement which involves the election of directors and is to be filed with the Securities and Exchange Commission pursuant to the Securities Exchange Act of 1934 within 120 days of the end of our fiscal year on December 31, 2015 and (b) the information appearing under Item 1 in Part I of this report.
 
Item 11.  Executive Compensation
 
The information required by this Item is hereby incorporated by reference from the information appearing under the captions “Corporate Governance” and “Executive and Director Compensation” in our definitive proxy statement which involves the election of directors and is to be filed with the Commission pursuant to the Securities Exchange Act of 1934 within 120 days of the end of our fiscal year on December 31, 2015. Notwithstanding the foregoing, in accordance with the instructions to Item 407(e)(5) of Regulation S-K, the information contained in our proxy statement under the sub-heading “Compensation Committee Report” shall not be deemed to be filed as part of or incorporated by reference into this annual report on Form 10-K.
 
Item 12.  Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
 
The information required by this Item is hereby incorporated by reference from the information appearing under the captions “Stock Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information” in our definitive proxy statement which involves the election of directors and is to be filed with the Commission pursuant to the Securities Exchange Act of 1934 within 120 days of the end of our fiscal year on December 31, 2015.
 
Item 13.  Certain Relationships and Related Transactions, and Director Independence
 
The information required by this Item is hereby incorporated by reference from the information appearing under the captions “Corporate Governance” and “Transactions with Related Persons” in our definitive proxy statement which involves the election of directors and is to be filed with the Commission pursuant to the Securities Exchange Act of 1934 within 120 days of the end of our fiscal year on December 31, 2015.
 
Item 14.   Principal Accounting Fees and Services
 
The information required by this Item as to the fees we pay our principal accountant is hereby incorporated by reference from the information appearing under the caption “Ratification and Approval of Independent Auditors” in our definitive proxy statement which involves the election of directors and is to be filed with the Commission pursuant to the Securities Exchange Act of 1934 within 120 days of the end of our fiscal year on December 31, 2015.


43

Table of Contents

PART IV

Item 15.               Exhibits and Financial Statement Schedules
 
(a)
Documents filed as a part of this report:

1.
Consolidated Financial Statements
 
 
Page

2.
Financial Statement Schedules
 
All other financial statement schedules are omitted because they are not applicable or not required, or because the required information is included in the financial statements or notes thereto.
 
3.           Exhibits
 
Exhibit No.

 
Description
3.1

Amended and Restated Certificate of Incorporation (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K dated April 26, 2012 and incorporated by reference herein).
3.2

Certificate of Amendment to Amended and Restated Certificate of Incorporation (filed as Exhibit 3.1 to the Company’s Current Report on Form 8-K dated May 20, 2015 and incorporated by reference herein).
3.3

Second Amended and Restated Bylaws (filed as Exhibit 3.2 to the Company’s Current Report on Form 8‑K dated April 26, 2012 and incorporated by reference herein).
4.1

Securities Purchase Agreement, dated June 17, 2007, with Invus, L.P. (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated June 17, 2007 and incorporated by reference herein).
4.2

Amendment, dated October 7, 2009, to Securities Purchase Agreement, dated June 17, 2007, with Invus, L.P. (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated October 7, 2009 and incorporated by reference herein).
4.3

Registration Rights Agreement, dated June 17, 2007, with Invus, L.P. (filed as Exhibit 10.3 to the Company’s Current Report on Form 8-K dated June 17, 2007 and incorporated by reference herein).
4.4

Stockholders’ Agreement, dated June 17, 2007, with Invus, L.P. (filed as Exhibit 10.4 to the Company’s Current Report on Form 8-K dated June 17, 2007 and incorporated by reference herein).
4.5

Supplement to Transaction Agreements, dated March 15, 2010, with Invus, L.P. and Invus C.V. (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated March 15, 2010 and incorporated by reference herein).
4.6

Supplement No. 2 to Transaction Agreements, dated February 23, 2012, with Invus, L.P. and Invus C.V. (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated February 23, 2012 and incorporated by reference herein).
4.7

Amended and Restated Purchase Option Agreement, dated July 30, 2010, with Symphony Icon Holdings LLC and Symphony Icon, Inc. (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated July 30, 2010 and incorporated by reference herein).
4.8

Amended and Restated Registration Rights Agreement, dated July 30, 2010, with Symphony Icon Holdings LLC (filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K dated July 30, 2010 and incorporated by reference herein).
4.9

Indenture related to the 5.25% Convertible Senior Notes due 2021, dated as of November 26, 2014, with Wells Fargo Bank, N.A. (filed as Exhibit 4.1 to the Company’s Current Report on Form 8-K dated November 26, 2014 and incorporated by reference herein).

44

Table of Contents

 

Exhibit No.

 
 Description
4.10

Form of 5.25% Convertible Senior Notes due 2021 (filed as Exhibit 4.2 to the Company’s Current Report on Form 8-K dated November 26, 2014 and incorporated by reference herein).
10.1

Offer Letter, dated July 1, 2014, with Lonnel Coats (filed as Exhibit 10.3 to the Company’s Current Report on Form 8-K dated July 7, 2014 and incorporated by reference herein).
10.2

Offer Letter, dated March 10, 2011, with Pablo Lapuerta, M.D. (filed as Exhibit 10.5 to the Company’s Annual Report on Form 10-K for the period ended December 31, 2011 and incorporated by reference herein).
10.3

Employment Agreement with Alan Main, Ph.D. (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2001 and incorporated by reference herein).
10.4

Employment Agreement with Jeffrey L. Wade, J.D. (filed as Exhibit 10.3 to the Company’s Registration Statement on Form S-1 (Registration No. 333-96469) and incorporated by reference herein).
10.5

Consulting Agreement with Alan S. Nies, M.D. dated February 19, 2003, as amended (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2010 and incorporated by reference herein).
10.6

Consulting Agreement with Robert J. Lefkowitz, M.D. dated March 31, 2003 (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2003 and incorporated by reference herein).
10.7

Form of Indemnification Agreement with Officers and Directors (filed as Exhibit 10.7 to the Company’s Registration Statement on Form S-1 (Registration No. 333-96469) and incorporated by reference herein).
*10.8

Summary of Non-Employee Director Compensation.
*10.9

Equity Incentive Plan.
*10.10

Non-Employee Directors’ Equity Incentive Plan.
10.11

Form of Stock Option Agreement with Officers under the Equity Incentive Plan (filed as Exhibit 10.15 to the Company’s Annual Report on Form 10-K for the period ended December 31, 2011 and incorporated by reference herein).
10.12

Form of Restricted Stock Unit Agreement with Officers under the Equity Incentive Plan (filed as Exhibit 10.15 to the Company’s Annual Report on Form 10-K for the period ended December 31, 2012 and incorporated by reference herein).
*10.13

Form of Notice of Stock Option Grant to Directors under the Non-Employee Directors’ Equity Incentive Plan.
*†10.14

Collaboration and License Agreement, dated November 5, 2015, with Sanofi.
†10.15

License and Collaboration Agreement, dated October 21, 2014, with Ipsen Pharma SAS (filed as Exhibit 10.1 to the amendment to the Company’s Quarterly Report on Form 10-Q/A for the period ended September 30, 2014, as filed on December 23, 2014, and incorporated by reference herein).
†10.16

First Amendment, dated March 17, 2015, to License and Collaboration Agreement, dated October 21, 2014, with Ipsen Pharma SAS (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2015 and incorporated by reference herein).
†10.17

Collaboration and License Agreement, dated December 17, 2003, with Bristol-Myers Squibb Company (filed as Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2015 and incorporated by reference herein).
 


45

Table of Contents

Exhibit No.
 
 Description
†10.18
First Amendment, dated May 30, 2006, to Collaboration and License Agreement, dated December 17, 2003, with Bristol-Myers Squibb Company (filed as Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2015 and incorporated by reference herein).
†10.19
Second Amended and Restated Collaboration and License Agreement, dated November 30, 2005, with Genentech, Inc. (filed as Exhibit 10.22 to the Company’s Annual Report on Form 10-K for the period ended December 31, 2005 and incorporated by reference herein).
10.20
Amendment, dated June 8, 2009, to Second Amended and Restated Collaboration and License Agreement, dated November 30, 2005, with Genentech, Inc. (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K/A dated June 8, 2009 and incorporated by reference herein).
10.21
Economic Development Agreement dated July 15, 2005, with the State of Texas and the Texas A&M University System (filed as Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2005 and incorporated by reference herein).
10.22
Amendment, dated April 30, 2008, to Economic Development Agreement, dated July 15, 2005, with the State of Texas and the Texas A&M University System (filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K dated April 30, 2008 and incorporated by reference herein).
10.23
Loan and Security Agreement, dated April 21, 2004, between Lex-Gen Woodlands, L.P. and iStar Financial Inc., as amended (filed as Exhibit 10.23 to the Company’s Annual Report on Form 10-K for the period ended December 31, 2014 and incorporated by reference herein).
10.24
Real Estate Purchase and Sale Agreement, dated January 21, 2016, between Lex-Gen Woodlands, L.P. and TC Houston Office Development, Inc. (filed as Exhibit 10.1 to the Company’s Current Report on Form 8­-K dated January 22, 2016 and incorporated by reference herein).
21.1
Subsidiaries (filed as Exhibit 21.1 to the Company’s Annual Report on Form 10-K for the period ended December 31, 2010 and incorporated by reference herein).
*23.1
Consent of Independent Registered Public Accounting Firm.
*24.1
Power of Attorney (contained in signature page).
*31.1
Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*31.2
Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*32.1
Certification of Principal Executive and Principal Financial Officers Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
*101.INS
XBRL Instance Document.
*101.SCH
XBRL Taxonomy Extension Schema Document.
*101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document.
*101.DEF
XBRL Taxonomy Extension Definition Linkbase Document.
*101.LAB
XBRL Taxonomy Extension Label Linkbase Document.
*101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document.
_____________________        
*
Filed herewith.
Confidential treatment has been requested for a portion of this exhibit.  The confidential portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.


46

Table of Contents

Signatures
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
 
 
Lexicon Pharmaceuticals, Inc.
Date:
March 11, 2016
By:
/s/ LONNEL COATS
 
 
 
Lonnel Coats
 
 
 
President and Chief Executive Officer
 
 
 
 
Date:
March 11, 2016
By:
/s/ JEFFREY L. WADE
 
 
 
Jeffrey L. Wade
 
 
 
Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer
Power of Attorney
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Lonnel Coats and Jeffrey L. Wade, or either of them, each with the power of substitution, his or her attorney-in-fact, to sign any amendments to this Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, here ratifying and confirming all that each of said attorneys-in-fact, or his or her substitute or substitutes, may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature
 
Title
Date
 
 
 
 
/s/ LONNEL COATS
 
President, Chief Executive Officer and Director
(Principal Executive Officer)
March 11, 2016
Lonnel Coats
 
 
 
 
 
 
/s/ JEFFREY L. WADE
 
Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer (Principal Financial Officer)
March 11, 2016
Jeffrey L. Wade
 
 
 
 
 
 
/s/ JAMES F. TESSMER
 
Vice President, Finance and Accounting
(Principal Accounting Officer)
March 11, 2016
James F. Tessmer
 
 
 
 
 
 
/s/ RAYMOND DEBBANE
 
Chairman of the Board of Directors
March 11, 2016
Raymond Debbane
 
 
 
 
 
 
 
/s/ PHILIPPE J. AMOUYAL
 
Director
March 11, 2016
Philippe J. Amouyal
 
 
 
 
 
 
 
/s/ SAMUEL L. BARKER
 
Director
March 11, 2016
Samuel L. Barker, Ph.D.
 
 
 
 
 
 
 
/s/ ROBERT J. LEFKOWITZ
 
Director
March 11, 2016
Robert J. Lefkowitz, M.D.
 
 
 
 
 
 
 
/s/ ALAN S. NIES
 
Director
March 11, 2016
Alan S. Nies, M.D.
 
 
 
 
 
 
 
/s/ FRANK P. PALANTONI
 
Director
March 11, 2016
Frank P. Palantoni
 
 
 
 
 
 
 
/s/ CHRISTOPHER J. SOBECKI
 
Director
March 11, 2016
Christopher J. Sobecki
 
 
 
 
 
 
 
/s/ JUDITH L. SWAIN
 
Director
March 11, 2016
Judith L. Swain, M.D.
 
 
 
 

47

Table of Contents



F-1

Table of Contents

Report of Independent
Registered Public Accounting Firm
 
The Board of Directors and Stockholders
of Lexicon Pharmaceuticals, Inc.:
 
We have audited the accompanying consolidated balance sheets of Lexicon Pharmaceuticals, Inc. as of December 31, 2015 and 2014, and the related consolidated statements of comprehensive loss, stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2015.  These financial statements are the responsibility of the Company’s management.  Our responsibility is to express an opinion on these financial statements based on our audits.
 
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
 
In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Lexicon Pharmaceuticals, Inc. as of December 31, 2015 and 2014, and the consolidated results of its operations and its cash flows for each of the three years in the period ended December 31, 2015, in conformity with U.S. generally accepted accounting principles.
 
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Lexicon Pharmaceuticals, Inc.’s internal control over financial reporting as of December 31, 2015, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) and our report dated March 11, 2016 expressed an unqualified opinion thereon.
 

/s/ Ernst & Young LLP

Houston, Texas
March 11, 2016
 

F-1

Table of Contents

Report of Independent
Registered Public Accounting Firm
 
The Board of Directors and Stockholders
of Lexicon Pharmaceuticals, Inc.:

We have audited Lexicon Pharmaceuticals, Inc.’s  internal control over financial reporting as of December 31, 2015, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission 2013 framework (the COSO criteria). Lexicon Pharmaceuticals, Inc.’s management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the company’s internal control over financial reporting based on our audit.
 
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
 
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
 
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.  Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
 
In our opinion, Lexicon Pharmaceuticals, Inc. maintained, in all material respects, effective internal control over financial reporting as of December 31, 2015, based on the COSO criteria.
 
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets of Lexicon Pharmaceuticals, Inc. and subsidiaries as of December 31, 2015 and 2014, and the related consolidated statements of comprehensive loss, stockholders’ equity, and cash flows for each of the three years in the period ended December 31, 2015 and our report dated March 11, 2016 expressed an unqualified opinion thereon.
 

/s/ Ernst & Young LLP


Houston, Texas
March 11, 2016

F-2

Table of Contents

Lexicon Pharmaceuticals, Inc.
Consolidated Balance Sheets
(In thousands, except par value)
 
As of December 31,
 
2015
 
2014
Assets
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
202,989

 
$
137,266

Short-term investments, including restricted investments of $0 and $430, respectively
318,363

 
202,073

Accounts receivable, net of allowances of $4 and $35, respectively
911

 
1,035

Assets held for sale

 
23,849

Prepaid expenses and other current assets
10,137

 
4,764

Total current assets
532,400

 
368,987

Property and equipment, net of accumulated depreciation and amortization of $59,428 and $36,274, respectively
21,227

 
1,080

Goodwill
44,543

 
44,543

Other intangible assets
53,357

 
53,357

Other assets
3,305

 
3,409

Total assets
$
654,832

 
$
471,376

Liabilities and Equity
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
19,725

 
$
13,064

Accrued liabilities
24,757

 
10,120

Current portion of deferred revenue
76,499

 
1,618

Current portion of long-term debt
2,015

 
20,167

Total current liabilities
122,996

 
44,969

Deferred revenue, net of current portion
109,151

 
12,679

Long-term debt
103,793

 
87,500

Deferred tax liabilities
18,675

 
18,675

Other long-term liabilities
14,367

 
23,535

Total liabilities
368,982

 
187,358

Commitments and contingencies

 

Equity:
 
 
 
Preferred stock, $.01 par value; 5,000 shares authorized; no shares issued and outstanding

 

Common stock, $.001 par value; 225,000 and 128,571 shares authorized; 103,860 and 103,663 shares issued, respectively
104

 
104

Additional paid-in capital
1,397,646

 
1,390,619

Accumulated deficit
(1,108,934
)
 
(1,104,252
)
Accumulated other comprehensive loss
(219
)
 
(63
)
Treasury stock, at cost, 237 and 183 shares, respectively
(2,747
)
 
(2,390
)
Total equity
285,850

 
284,018

Total liabilities and equity
$
654,832

 
$
471,376


The accompanying notes are an integral part of these consolidated financial statements.

F-3

Table of Contents

Lexicon Pharmaceuticals, Inc.
 
Consolidated Statements of Comprehensive Loss
(In thousands, except per share amounts)
 

 
Year Ended December 31,
 
2015
 
2014
 
2013
Revenues:
 
 
 
 
 
Collaborative agreements
$
129,728

 
$
22,593

 
$
2,109

Subscription and license fees
286

 
261

 
113

Total revenues
130,014

 
22,854

 
2,222

Operating expenses:
 
 
 

 
 

Research and development, including stock-based compensation of $3,693, $4,020 and $4,376, respectively
95,187

 
89,279

 
89,682

Increase (decrease) in fair value of Symphony Icon, Inc. purchase liability
5,927

 
1,428

 
(2,210
)
General and administrative, including stock-based compensation of $3,150, $3,061 and $3,045, respectively
23,835

 
19,411

 
17,121

Impairment loss on buildings
3,597

 
13,102

 

Total operating expenses
128,546

 
123,220

 
104,593

Income (loss) from operations
1,468

 
(100,366
)
 
(102,371
)
Interest expense
(6,722
)
 
(2,253
)
 
(1,971
)
Interest and other income, net
572

 
2,255

 
216

Consolidated net loss before taxes
(4,682
)
 
(100,364
)
 
(104,126
)
Income tax benefit

 
70

 

Consolidated net loss
$
(4,682
)
 
$
(100,294
)
 
$
(104,126
)
Consolidated net loss per common share, basic and diluted
$
(0.05
)
 
$
(1.31
)
 
$
(1.42
)
Shares used in computing consolidated net loss per common share, basic and diluted
103,591

 
76,347

 
73,302

 
 
 
 
 
 
Other comprehensive loss:
 
 
 
 
 
Unrealized loss on investments
(156
)
 
(65
)
 
(21
)
Comprehensive loss
$
(4,838
)
 
$
(100,359
)
 
$
(104,147
)

The accompanying notes are an integral part of these consolidated financial statements.


F-4

Table of Contents

Lexicon Pharmaceuticals, Inc.
 
Consolidated Statements of Stockholders’ Equity
(In thousands)
 
 
 
 
 
 
 
 
 
 
Accumulated
 
 
 
 
 
 
 
 
 
Additional
 
 
 
Other
 
 
 
 
 
Common Stock
 
Paid-In
 
Accumulated
 
Comprehensive
 
Treasury
 
 
 
Shares
 
Par Value
 
Capital
 
Deficit
 
Gain (Loss)
 
Stock
 
Total
Balance at December 31, 2012
73,196

 
$
73

 
$
1,167,044

 
$
(899,832
)
 
$
23

 
$
(630
)
 
$
266,678

Stock-based compensation

 

 
7,421

 

 

 

 
7,421

Issuance of common stock under Equity Incentive Plans
282

 

 
1,084

 

 

 

 
1,084

Repurchase of common stock

 

 

 

 

 
(873
)
 
(873
)
Net loss

 

 

 
(104,126
)
 

 

 
(104,126
)
Unrealized loss on investments

 

 

 

 
(21
)
 

 
(21
)
Balance at December 31, 2013
73,478

 
73

 
1,175,549

 
(1,003,958
)
 
2

 
(1,503
)
 
170,163

Stock-based compensation

 

 
7,081

 

 

 

 
7,081

Issuance of common stock to designees of Symphony Icon Holdings LLC
666

 
1

 
5,749

 

 

 

 
5,750

Issuance of common stock under Equity Incentive Plans
252

 
1

 
322

 

 

 

 
323

Issuance of common stock, net of fees
29,267

 
29

 
201,918

 

 

 

 
201,947

Repurchase of common stock

 

 

 

 

 
(887
)
 
(887
)
Net loss

 

 

 
(100,294
)
 

 

 
(100,294
)
Unrealized loss on investments

 

 

 

 
(65
)
 

 
(65
)
Balance at December 31, 2014
103,663

 
104

 
1,390,619

 
(1,104,252
)
 
(63
)
 
(2,390
)
 
284,018

Stock-based compensation

 

 
6,843

 

 

 

 
6,843

Issuance of common stock under Equity Incentive Plans
197

 

 
114

 

 

 

 
114

Repurchase of common stock

 

 

 

 

 
(357
)
 
(357
)
Net loss

 

 

 
(4,682
)
 

 

 
(4,682
)
Unrealized loss on investments

 

 

 

 
(156
)
 

 
(156
)
Other

 

 
70

 

 

 

 
70

Balance at December 31, 2015
103,860

 
$
104

 
$
1,397,646

 
$
(1,108,934
)
 
$
(219
)
 
$
(2,747
)
 
$
285,850

 
The accompanying notes are an integral part of these consolidated financial statements.
 

F-5

Table of Contents

Lexicon Pharmaceuticals, Inc.
 
Consolidated Statements of Cash Flows
(In thousands)
 
 
Year Ended December 31,
 
2015
 
2014
 
2013
Cash flows from operating activities:
 
 
 
 
 
Consolidated net loss
$
(4,682
)
 
$
(100,294
)
 
$
(104,126
)
Adjustments to reconcile consolidated net loss to net cash provided by (used in) operating activities:
 
 
 

 
 

Depreciation and amortization
727

 
1,928

 
2,863

Impairment of assets
3,597

 
13,544

 

Increase (decrease) in fair value of Symphony Icon, Inc. purchase liability
5,927

 
1,428

 
(2,210
)
Stock-based compensation
6,843

 
7,081

 
7,421

Gain on disposal of property and equipment
(47
)
 
(1,631
)
 

Amortization of debt issuance costs
520

 
100

 

Deferred tax benefit

 
(70
)
 

Changes in operating assets and liabilities:
 
 
 

 
 

Decrease in accounts receivable
124

 
457

 
588

(Increase) decrease in prepaid expenses and other current assets
(5,373
)
 
(128
)
 
1,713

Increase in other assets
(416
)
 

 
(9
)
Increase in accounts payable and other liabilities
6,203

 
1,266

 
3,119

Increase (decrease) in deferred revenue                                                                                
171,353

 
697

 
(438
)
Net cash provided by (used in) operating activities
184,776

 
(75,622
)
 
(91,079
)
Cash flows from investing activities:
 
 
 

 
 

Purchases of property and equipment
(910
)
 
(80
)
 
(1,721
)
Proceeds from disposal of property and equipment
335

 
2,170

 
130

Purchases of investments
(326,446
)
 
(221,953
)
 
(111,490
)
Maturities of investments                                                                                       
210,000

 
111,444

 
212,625

Net cash provided by (used in) investing activities
(117,021
)
 
(108,419
)
 
99,544

Cash flows from financing activities:
 
 
 

 
 

Proceeds from issuance of common stock, net of fees
114

 
202,270

 
1,084

Repurchase of common stock
(357
)
 
(887
)
 
(873
)
Proceeds from debt borrowings, net of fees

 
84,135

 

Repayment of debt borrowings
(1,859
)
 
(1,710
)
 
(1,574
)
Other financing activities
70

 

 
(26
)
Net cash provided by (used in) financing activities
(2,032
)
 
283,808

 
(1,389
)
Net increase in cash and cash equivalents
65,723

 
99,767

 
7,076

Cash and cash equivalents at beginning of year                                                                                           
137,266

 
37,499

 
30,423

Cash and cash equivalents at end of year                                                                                           
$
202,989

 
$
137,266

 
$
37,499

 
 
 
 
 
 
Supplemental disclosure of cash flow information:
 
 
 

 
 

Cash paid for interest
$
6,270

 
$
1,761

 
$
1,897

 
 
 
 
 
 
Supplemental disclosure of noncash investing and financing activities:
 
 
 

 
 

Unrealized loss on investments
$
(156
)
 
$
(65
)
 
$
(21
)
Common stock issued in satisfaction of Symphony Icon payment obligation
$

 
$
5,750

 
$


The accompanying notes are an integral part of these consolidated financial statements.

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Lexicon Pharmaceuticals, Inc.
 
Notes to Consolidated Financial Statements
 
December 31, 2015
 
1. Organization and Operations
 
Lexicon Pharmaceuticals, Inc. (“Lexicon” or the “Company”) is a Delaware corporation incorporated on July 7, 1995. Lexicon was organized to discover the functions and pharmaceutical utility of genes and use those gene function discoveries in the discovery and development of pharmaceutical products for the treatment of human disease.
 
Lexicon has financed its operations from inception primarily through sales of common and preferred stock, contract and milestone payments to it under strategic collaborations and other research and development collaborations, target validation, database subscription and technology license agreements, government grants and contracts and financing under debt and lease arrangements. The Company’s future success is dependent upon many factors, including, but not limited to, its ability to develop and obtain regulatory approval for its products, successfully commercialize its products which gain regulatory approval, achieve milestones under its collaboration agreements, establish new collaboration and license agreements, obtain and enforce patents and other proprietary rights in its discoveries, comply with federal and state regulations, and maintain sufficient capital to fund its activities.  As a result of the aforementioned factors and the related uncertainties, there can be no assurance of the Company’s future success.
 
2. Summary of Significant Accounting Policies
 
Basis of Presentation: The accompanying consolidated financial statements include the accounts of Lexicon and its wholly-owned subsidiaries. Intercompany transactions and balances are eliminated in consolidation.
 
Use of Estimates: The preparation of financial statements in conformity with U. S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates.
 
Cash, Cash Equivalents and Short-Term Investments: Lexicon considers all highly-liquid investments with original maturities of three months or less to be cash equivalents.  As of December 31, 2015, short-term investments consist of U.S. treasury bills and corporate debt securities. As of December 31, 2014, short-term investments consist of U.S. treasury bills and certificates of deposit. The Company’s short-term investments are classified as available-for-sale securities and are carried at fair value, based on quoted market prices of the securities.  The Company views its available-for-sale securities as available for use in current operations regardless of the stated maturity date of the security.  Unrealized gains and losses on such securities are reported as a separate component of stockholders’ equity.  Net realized gains and losses, interest and dividends are included in interest income.  The cost of securities sold is based on the specific identification method.
 
Restricted Cash and Investments:  Lexicon was required to maintain restricted cash or investments to collateralize standby letters of credit for the lease on its office and laboratory facilities in Hopewell, New Jersey that terminated in June 2015.  As of December 31, 2015 and 2014, restricted cash and investments were zero and $0.4 million, respectively.
 
Accounts Receivable:  Lexicon records trade accounts receivable in the normal course of business related to the sale of products or services.   The allowance for doubtful accounts takes into consideration such factors as historical write-offs, the economic climate and other factors that could affect collectibility.  Write-offs are evaluated on a case by case basis.
 
Concentration of Credit Risk: Lexicon’s cash equivalents, investments and accounts receivable represent potential concentrations of credit risk. The Company attempts to minimize potential concentrations of risk in cash equivalents and investments by placing investments in high-quality financial instruments. The Company’s accounts receivable are unsecured and are concentrated in pharmaceutical and biotechnology companies located in the United States.  The Company has not experienced any significant credit losses to date.  In 2015, customers in France and the United States represented 99% and 1% of revenue, respectively. In 2014, customers in France and the United States represented 94% and 6%, respectively. In 2013, customers in the United States represented 100% of revenue.  At December 31, 2015, management believes that the Company has no significant concentrations of credit risk.
 

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Segment Information and Significant Customers: Lexicon operates in one business segment, which primarily focuses on the discovery of the functions and pharmaceutical utility of genes and the use of those gene function discoveries in the discovery and development of pharmaceutical products for the treatment of human disease. Substantially all of the Company’s revenues have been derived from drug discovery alliances, target validation collaborations for the development and, in some cases, analysis of the physiological effects of genes altered in knockout mice, technology licenses, subscriptions to its databases, government grants and contracts and compound library sales. In 2015, Sanofi represented 98% of revenues. In 2014, Ipsen Pharma SAS represented 94% of revenues. In 2013, McNair Medical Institute, LLC and Taconic Farms, Inc. represented 57% and 33% of revenues, respectively.    
 
Property and Equipment: Property and equipment that is held and used is carried at cost and depreciated using the straight-line method over the estimated useful life of the assets which ranges from three to 40 years.  Maintenance, repairs and minor replacements are charged to expense as incurred.  Leasehold improvements are amortized over the shorter of the estimated useful life or the remaining lease term.  Significant renewals and betterments are capitalized.
 
Impairment of Long-Lived Assets:  Long-lived assets and certain identifiable intangible assets to be held and used are reviewed for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by comparison of the carrying amount of an asset to future net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount that the carrying amount of the assets exceeds the fair value of the assets. Assets to be disposed of are reported at the lower of the carrying amount or fair value less costs to sell. In 2014, Lexicon reclassified its buildings and land as assets held for sale, as it intended to sell these assets, and recorded an impairment loss of $13.1 million in the year ended December 31, 2014. In the fourth quarter of 2015, Lexicon made a change to its plan of sale and reclassified its buildings and land as assets held and used in accordance with the accounting guidance regarding selling assets with a leaseback requirement, and recorded an additional impairment loss of $3.6 million in the year ended December 31, 2015 (see Note 6, Buildings and Land for Sale).

Indefinite lived intangible assets are also tested annually for impairment and whenever indicators of impairment are present. When performing the impairment assessment, the Company first assesses qualitative factors to determine whether it is necessary to recalculate the fair value of its intangible assets. If management believes, as a result of the qualitative assessment, that it is more likely than not that the fair value of the intangible assets is less than its carrying amount, the Company calculates the asset’s fair value. If the carrying value of the asset exceeds its fair value, then the intangible asset is written down to its fair value.

Goodwill Impairment:  Goodwill is not amortized, but is tested at least annually for impairment at the reporting unit level.  The Company has determined that the reporting unit is the single operating segment disclosed in its current financial statements. Impairment is the condition that exists when the carrying amount of goodwill exceeds its implied fair value.  The first step in the impairment process is to determine the fair value of the reporting unit and then compare it to the carrying value, including goodwill.  If the fair value exceeds the carrying value, no further action is required and no impairment loss is recognized.  Additional impairment assessments may be performed on an interim basis if the Company encounters events or changes in circumstances that would indicate that, more likely than not, the carrying value of goodwill has been impaired.  There was no impairment of goodwill in 2015, 2014 or 2013.
 
Revenue Recognition: Revenues are recognized when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectibility is reasonably assured.  

Collaborative agreements revenues include both license revenue and contract research revenue. Activities under collaborative agreements are evaluated to determine if they represent a multiple element revenue agreement. The Company identifies the deliverables included within the agreement and evaluates which deliverables represent separate units of accounting. The Company accounts for those components as separate units of accounting if the following two criteria are met:

The delivered item or items have value to the customer on a stand-alone basis.
If there is a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and within the Company’s control.

Factors considered in this determination include, among other things, whether any other vendors sell the items separately and if the licensee could use the delivered item for its intended purpose without the receipt of the remaining deliverables. If multiple deliverables included in an arrangement are separable into different units of accounting, the Company allocates the arrangement consideration to those units of accounting. The amount of allocable arrangement consideration is limited to amounts that are fixed or determinable. Arrangement consideration is allocated at the inception of the arrangement

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to the identified units of accounting based on their relative estimated selling price. Revenue is recognized for each unit of accounting when the appropriate revenue recognition criteria are met.

Future milestone payments that are contingent upon the achievement of a substantive milestone are recognized in their entirety in the period in which the milestone is achieved. A milestone is substantive if:

It can only be achieved based in whole or in part on either the Company’s performance or on the occurrence of a specific outcome resulting from the Company’s performance;
There is substantive uncertainty at the date an arrangement is entered into that the event will be achieved; and
It would result in additional payments being due to the Company.

Subscription and license fees are recognized as revenue upon the grant of the technology license when performance is complete and there is no continuing involvement. Royalty revenues are recognized as earned in accordance with the contract terms at the time the royalty amount is fixed and determinable based on information received from the sublicensees and at the time collectibility is reasonably assured.

Research and Development Expenses: Research and development expenses consist of costs incurred for company-sponsored as well as collaborative research and development activities. These costs include direct and research-related overhead expenses and are expensed as incurred.  Technology license fees for technologies that are utilized in research and development and have no alternative future use are expensed when incurred. Substantial portions of the Company’s preclinical and clinical trials are performed by third-party laboratories, medical centers, contract research organizations and other vendors. For preclinical studies, the Company accrues expenses based upon estimated percentage of work completed and the contract milestones remaining. For clinical studies, expenses are accrued based upon the number of patients enrolled and the duration of the study. The Company monitors patient enrollment, the progress of clinical studies and related activities to the extent possible through internal reviews of data reported to the Company by the vendors and clinical site visits. The Company’s estimates depend on the timeliness and accuracy of the data provided by the vendors regarding the status of each program and total program spending. The Company periodically evaluates the estimates to determine if adjustments are necessary or appropriate based on information it receives.
 
Stock-Based Compensation:  The Company recognizes compensation expense in its statements of comprehensive loss for share-based payments, including stock options and restricted stock units issued to employees, based on their fair values on the date of the grant, with the compensation expense recognized over the period in which an employee is required to provide service in exchange for the stock award.  Stock-based compensation expense for awards without performance conditions is recognized on a straight-line basis. Stock-based compensation expense for awards with performance conditions is recognized over the period from the date the performance condition is determined to be probable of occurring through the time the applicable condition is met.  As of December 31, 2015, stock-based compensation cost for all outstanding unvested options and restricted stock units was $10.5 million, which is expected to be recognized over a weighted-average period of 1.3 years.
 
The fair value of stock options is estimated at the date of grant using the Black-Scholes method.  The Black-Scholes option-pricing model requires the input of subjective assumptions.  Because the Company’s employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in management’s opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its employee stock options.  For purposes of determining the fair value of stock options, the Company segregates its options into two homogeneous groups, based on exercise and post-vesting employment termination behaviors, resulting in a change in the assumptions used for expected option lives and forfeitures.  Expected volatility is based on the historical volatility in the Company’s stock price.  The following weighted-average assumptions were used for options granted in the years ended December 31, 2015, 2014 and 2013, respectively:

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Expected Volatility
 
Risk-free Interest Rate
 
Expected Term
 
Dividend
Rate
December 31, 2015:
 
 
 
 
 
 
 
Employees
64%
 
1.2%
 
4
 
0
%
Officers and non-employee directors
81%
 
1.8%
 
8
 
0
%
December 31, 2014:

 

 

 

Employees
66%
 
1.2%
 
4
 
0
%
Officers and non-employee directors
80%
 
2.3%
 
8
 
0
%
December 31, 2013:

 

 

 

Employees
85%
 
0.9%
 
5
 
0
%
Officers and non-employee directors
81%
 
1.6%
 
8
 
0
%
 
Net Loss per Common Share: Net loss per common share is computed using the weighted average number of shares of common stock outstanding. Shares associated with convertible debt, stock options and restricted stock units are not included because they are antidilutive.
 
3. Recent Accounting Pronouncements
 
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers”, which amends FASB ASC Topic 606. ASU 2014-09 provides a single, comprehensive revenue recognition model for all contracts with customers. This standard contains principles for the determination of the measurement of revenue and the timing of when such revenue is recognized. Revenue recognition will reflect the transfer of goods or services to customers at an amount that is expected to be earned in exchange for those goods or services. ASU 2014-09 was scheduled to be effective for annual reporting periods beginning after December 15, 2016, and early adoption was not permitted. In August 2015, the FASB issued ASU No. 2015-14, “Revenue from Contracts with Customers: Deferral of Effective Date”, which defers the effective date of ASU 2014-09 by one year. ASU 2014-19 is now effective for annual periods after December 15, 2017 including interim periods within that reporting period. Early application is permitted only for annual periods beginning after December 15, 2016, including interim periods within that reporting period. Management is currently evaluating the impact of this pronouncement on Lexicon’s consolidated financial statements.

In August 2014, the FASB issued ASU No. 2014-15, “Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern.” ASU 2014-15 will explicitly require management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosure in certain circumstances. This pronouncement is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016, and early adoption is permitted. Management does not expect the adoption of this pronouncement to have a material impact on Lexicon’s consolidated financial statements.

In April 2015, the FASB issued ASU No. 2015-03, “Simplifying the Presentation of Debt Issuance Costs.” ASU
2015-03 requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct
deduction from the carrying amount of that debt liability, consistent with debt discounts. This pronouncement is effective for
fiscal years, and interim periods within those years, beginning after December 15, 2015, and early adoption is permitted. Management does not expect the adoption of this pronouncement to have a material impact on Lexicon’s consolidated financial statements.

In January 2016, the FASB issued ASU No. 2016-01, “Recognition and Measurement of Financial Assets and Financial Liabilities.” ASU 2016-01 requires that most equity investments be measured at fair value, with subsequent changes in fair value recognized in net income. The pronouncement also impacts financial liabilities under the fair value option and the presentation and disclosure requirements for financial instruments. This pronouncement is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017, and early adoption is not permitted. Management does not expect the adoption of this pronouncement to have a material impact on Lexicon’s consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, “Leases.” ASU 2016-01 requires companies that lease assets to recognize a right-of-use asset and a lease liability, initially measured at the present value of the lease payments, in its balance sheet. The pronouncement will also require additional disclosures about the amount, timing and uncertainty of cash flows arising from leases. This pronouncement is effective for fiscal years, and interim periods within those years, beginning after

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December 15, 2018, and early adoption is permitted. Management is currently evaluating the impact of this pronouncement on Lexicon’s consolidated financial statements.

4. Cash and Cash Equivalents and Investments
 
The fair value of cash and cash equivalents and investments held at December 31, 2015 and 2014 are as follows:
 
As of December 31, 2015
 
Amortized Cost
 
Gross Unrealized Gains
 
Gross Unrealized Losses
 
Estimated Fair Value
 
 
 
(in thousands)
 
 
Cash and cash equivalents
$
202,989

 
$

 
$

 
$
202,989

Securities maturing within one year:
 
 
 
 
 
 
 
U.S. treasury securities
313,105

 
2

 
(219
)
 
312,888

Corporate debt securities
5,477

 

 
(2
)
 
5,475

Total short-term investments
$
318,582

 
$
2

 
$
(221
)
 
$
318,363

Total cash and cash equivalents and investments
$
521,571

 
$
2

 
$
(221
)
 
$
521,352

 
 
As of December 31, 2014
 
Amortized Cost
 
Gross Unrealized Gains
 
Gross Unrealized Losses
 
Estimated Fair Value
 
 
 
(in thousands)
 
 
Cash and cash equivalents
$
137,266

 
$

 
$

 
$
137,266

Securities maturing within one year:
 
 
 
 
 
 
 
Certificates of deposit
552

 

 

 
552

U.S. treasury securities
201,584

 
3

 
(66
)
 
201,521

Total short-term investments
$
202,136

 
$
3

 
$
(66
)
 
$
202,073

Total cash and cash equivalents and investments
$
339,402

 
$
3

 
$
(66
)
 
$
339,339


There were no realized gains or losses for the year ended December 31, 2015, no realized gains or losses for the year ended December 31, 2014, and no realized gains or losses for the year ended December 31, 2013.  

5. Fair Value Measurements
 
The Company uses various inputs in determining the fair value of its investments and measures these assets on a recurring basis.  Assets and liabilities recorded at fair value in the consolidated balance sheets are categorized by the level of objectivity associated with the inputs used to measure their fair value.  The following levels are directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities:
 
Level 1 – quoted prices in active markets for identical assets, which include U.S. treasury securities
 
Level 2 – other significant observable inputs (including quoted prices for similar investments, market corroborated inputs, etc.), which include corporate debt securities
 
Level 3 – significant unobservable inputs (including the Company’s own assumptions in determining the fair value of the Symphony Icon purchase consideration liability)
 
The inputs or methodology used for valuing securities are not necessarily an indication of the credit risk associated with investing in those securities.  The following tables provide the fair value measurements of applicable Company assets and liabilities that are measured at fair value on a recurring basis according to the fair value levels defined above as of December 31, 2015 and 2014.
 

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Table of Contents

 
Assets and Liabilities at Fair Value
 
As of December 31, 2015
 
Level 1
 
Level 2
 
Level 3
 
Total
 
(in thousands)
Assets
 
 
 
 
 
 
 
Cash and cash equivalents
$
200,526

 
$
2,463

 
$

 
$
202,989

Short-term investments
312,888

 
5,475

 

 
318,363

Total cash and cash equivalents and investments
$
513,414

 
$
7,938

 
$

 
$
521,352

Liabilities
 
 
 
 
 
 
 
Accrued liabilities
$

 
$

 
$
12,453

 
$
12,453

Other long-term liabilities

 

 
10,362

 
10,362

Total liabilities
$

 
$

 
$
22,815

 
$
22,815



 
Assets and Liabilities at Fair Value
 
As of December 31, 2014
 
Level 1
 
Level 2
 
Level 3
 
Total
 
(in thousands)
Assets
 
 
 
 
 
 
 
Cash and cash equivalents
$
137,266

 
$

 
$

 
$
137,266

Short-term investments
201,521

 
552

 

 
202,073

Total cash and cash equivalents and investments
$
338,787

 
$
552

 
$

 
$
339,339

Liabilities
 
 
 
 
 
 
 
Other long-term liabilities
$

 
$

 
$
17,638

 
$
17,638

Total liabilities
$

 
$

 
$
17,638

 
$
17,638


The Company did not have any Level 3 assets during the years ended December 31, 2015, 2014 and 2013. Transfers between levels are recognized at the actual date of circumstance that caused the transfer. The Company’s Level 3 liabilities represent the contingent purchase consideration payable to Symphony Icon, and are estimated using a probability-based income approach utilizing an appropriate discount rate. Subsequent changes in the fair value of the Symphony Icon (“Symphony Icon”) purchase consideration liability are recorded as an increase or decrease in Symphony Icon purchase liability in the accompanying consolidated statements of comprehensive loss. The fair value of the Symphony Icon purchase consideration liability increased by $5.9 million during the year ended December 31, 2015, increased by $1.4 million during the year ended December 31, 2014, and decreased by $2.2 million during the year ended December 31, 2013. The following table summarizes the change in consolidated balance sheet carrying value associated with Level 3 liabilities for the years ended December 31, 2013, 2014 and 2015.

 
Other Long-term Liabilities
 
(in thousands)
Balance at December 31, 2012
$
29,920

Change in valuation of purchase consideration payable to former Symphony Icon stockholders
(2,210
)
Balance at December 31, 2013
27,710

Change in valuation of purchase consideration payable to former Symphony Icon stockholders
1,428

Payment of base payment obligation with common stock and cash
(11,500
)
Balance at December 31, 2014
17,638

Change in valuation of purchase consideration payable to former Symphony Icon stockholders
5,927

Payment of contingent payment obligation with cash
(750
)
Balance at December 31, 2015
$
22,815


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Table of Contents


The Company also has assets that under certain conditions are subject to measurement at fair value on a non-recurring basis.  These assets include goodwill associated with the acquisitions of Coelacanth Corporation in 2001 and Symphony Icon in 2010 and intangible assets associated with the acquisition of Symphony Icon in 2010.  For these assets, measurement at fair value in periods subsequent to their initial recognition is applicable if one or more is determined to be impaired.
 
6. Buildings and Land for Sale
 
In 2014, Lexicon reclassified its buildings and land to assets held for sale on the consolidated balance sheet, as it intended to sell these assets. In the fourth quarter of 2015, Lexicon made a change to its plan of sale and reclassified its buildings and land as assets held and used in accordance with the accounting guidance regarding selling assets with a leaseback requirement. The Company estimated the fair value of the net assets to be sold at approximately $20.3 million and $23.8 million as of December 31, 2015 and 2014, respectively, which represents estimated selling price less costs to sell. This resulted in an impairment loss on the buildings of $3.6 million and $13.1 million in the years ended December 31, 2015 and 2014, respectively, which were recorded in impairment loss on buildings in the accompanying consolidated statements of comprehensive loss. The fair value of the net assets to be sold was determined using Level 2 inputs using sales prices in similar real estate sales and offers received from potential purchasers of the building.

In January 2016, Lexicon entered into a Real Estate Purchase and Sale Agreement (“Real Estate Agreement”) with TC Houston Office Development, Inc. (“Purchaser).” Under the Real Estate Agreement, Lexicon agreed to sell its facilities in The Woodlands, Texas to Purchaser for a purchase price of $21.2 million. Such sale is subject to normal and customary closing conditions, including a study period, which extends until March 21, 2016, subject to extension, during which Purchaser may conduct inspections, analyses and other studies of the property and may terminate the Real Estate Agreement in its discretion. Such sale is also subject to the negotiation and execution by the parties of a leaseback agreement with respect to a portion of the property concurrently with closing.

7. Property and Equipment
 
Property and equipment at December 31, 2015 and 2014 are as follows:
 
Estimated Useful Lives
 
As of December 31,
 
In Years
 
2015
 
2014
 
 
 
 
 
(in thousands)
Computers and software
3-5
 
$
8,457

 
$
9,468

Furniture and fixtures
5-7
 
6,269

 
7,032

Laboratory equipment
3-7
 
3,908

 
12,737

Leasehold improvements
7-10
 
240

 
8,117

Buildings
15-40
 
59,117

 

Land
 

 
 
2,664

 

Total property and equipment
 
 
 
 
80,655

 
37,354

Less: Accumulated depreciation and amortization
 
 
 
 
(59,428
)
 
(36,274
)
Net property and equipment
 
 
 
 
$
21,227

 
$
1,080

 
Buildings of $59.1 million and land of $2.7 million, as well as $38.0 million of related accumulated depreciation, have been reclassified to assets held for sale as of December 31, 2014. In 2015, these assets were reclassified to assets held and used, and are therefore disclosed as property and equipment as of December 31, 2015 (see Note 6, Buildings and Land for Sale).

8. Income Taxes
 
Lexicon recognizes deferred tax liabilities and assets for the expected future tax consequences of events that have been recognized differently in the financial statements and tax returns. Under this method, deferred tax liabilities and assets are determined based on the difference between the financial statement carrying amounts and tax bases of liabilities and assets using enacted tax rates and laws in effect in the years in which the differences are expected to reverse. Deferred tax assets are evaluated for realization based on a more-likely-than-not criteria in determining if a valuation allowance should be provided.

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Table of Contents

 
The components of Lexicon’s deferred tax assets (liabilities) at December 31, 2015 and 2014 are as follows:
 
 
As of December 31,
 
2015
 
2014
 
(in thousands)
Deferred tax assets:
 
 
 
Net operating loss carryforwards
$
263,138

 
$
255,518

Research and development tax credits
43,728

 
40,173

Capitalized research and development
85,385

 
95,946

Stock-based compensation
8,160

 
7,648

Deferred revenue
4,363

 
4,457

Other
8,831

 
8,681

Total deferred tax assets
413,605

 
412,423

Deferred tax liabilities:
 
 
 
Deferred tax liability related to acquisition of Symphony Icon
(18,675
)

(18,675
)
Total deferred tax liabilities
(18,675
)
 
(18,675
)
Less: valuation allowance
(413,605
)
 
(412,423
)
Net deferred tax liabilities
$
(18,675
)
 
$
(18,675
)

The $18.7 million deferred tax liability relates to the tax impact of future amortization or possible impairments associated with intangible assets acquired with Symphony Icon, which are not deductible for tax purposes. Lexicon does not believe it can estimate the reversal of the temporary difference related to the assets acquired with sufficient certainty such that the related deferred tax liability could be considered as a source of taxable income in assessing the Company’s need for a valuation allowance.

At December 31, 2015, Lexicon had both federal and state NOL carryforwards of approximately $738.0 million and $455.1 million, respectively.  The federal and state NOL carryforwards began to expire in 2011 and continued to expire in 2012.  The Company’s R&D tax credit carryforwards of approximately $43.7 million began to expire in 2012.  Utilization of the NOL and R&D credit carryforwards may be subject to a significant annual limitation due to ownership changes that have occurred previously or could occur in the future provided by Section 382 of the Internal Revenue Code.  Based on the federal tax law limits and the Company’s cumulative loss position, Lexicon concluded it was appropriate to establish a full valuation allowance for its net deferred tax assets until an appropriate level of profitability is sustained.  During the year ended December 31, 2015, the valuation allowance increased $1.2 million, primarily due to the Company’s current year net loss.  Lexicon recorded income tax benefits of $0, $70,000 and $0 in the years ended December 31, 2015, 2014 and 2013, respectively. As of December 31, 2015 and 2014, the Company did not have any unrecognized tax benefits.
 
The Company is primarily subject to U.S. federal and New Jersey and Texas state income taxes.  The tax years 1995 to current remain open to examination by U.S. federal authorities and 2004 to current remain open to examination by state authorities.  The Company’s policy is to recognize interest and penalties related to income tax matters in income tax expense.  As of December 31, 2015 and 2014, the Company had no accruals for interest or penalties related to income tax matters.
 
9. Goodwill
 
On July 12, 2001, Lexicon completed the acquisition of Coelacanth Corporation in a merger. Coelacanth, now Lexicon Pharmaceuticals (New Jersey), Inc., formed the core of the Company’s division responsible for small molecule compound discovery.  The results of Lexicon Pharmaceuticals (New Jersey), Inc. are included in the Company’s results of operations for the period subsequent to the acquisition. Goodwill associated with the acquisition of $25.8 million, which represents the excess of the $36.0 million purchase price over the fair value of the underlying net identifiable assets, was assigned to the consolidated entity, Lexicon.  

On July 30, 2010, Lexicon exercised its Purchase Option (as defined in Note 11) and completed the acquisition of Symphony Icon. Goodwill associated with the acquisition of $18.7 million, which represents the assets recognized in

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connection with the deferred tax liability acquired and did not result from excess purchase price, was assigned to the consolidated entity, Lexicon.

Goodwill is not subject to amortization, but is tested at least annually for impairment at the reporting unit level, which is the Company’s single operating segment.  The Company performed an impairment test of goodwill on its annual impairment assessment date.  This test did not result in an impairment of goodwill.

10. Debt Obligations
 
Convertible Debt. In November 2014, Lexicon completed an offering of $87.5 million in aggregate principal amount of its 5.25% Convertible Senior Notes due 2021 (the “Notes”). The conversion feature did not meet the criteria for bifurcation as required by generally accepted accounting principles and the entire principal amount was recorded as long-term debt on the Company’s consolidated balance sheets.

The Notes are governed by an indenture (the “Indenture”), dated as of November 26, 2014, between the Company and Wells Fargo Bank, N.A., as trustee. The Notes bear interest at a rate of 5.25% per year, payable semiannually in arrears on June 1 and December 1 of each year, beginning on June 1, 2015. The Notes mature on December 1, 2021. The Company may not redeem the Notes prior to the maturity date, and no sinking fund is provided for the Notes.

Holders of the Notes may convert their Notes at their option at any time prior to the close of business on the business day immediately preceding the maturity date. Upon conversion, the Company will deliver for each $1,000 principal amount of converted Notes a number of shares of its common stock equal to the conversion rate, as described in the Indenture. The conversion rate is initially 118.4553 shares of common stock per $1,000 principal amount of Notes (equivalent to an initial conversion price of $8.442 per share of common stock). The conversion rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date, the Company will increase the conversion rate for a holder who elects to convert its Notes in connection with such a corporate event in certain circumstances.

If the Company undergoes a fundamental change, holders may require the Company to repurchase for cash all or any portion of their Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

In connection with the issuance of the Notes, the Company incurred $3.4 million of debt issuance costs, which is included in other assets on the consolidated balance sheets. The debt issuance costs are amortized as interest expense over the expected life of the Notes using the effective interest method. The Company determined the expected life of the debt was equal to the seven-year term of the Notes. As of December 31, 2015, the balance of unamortized debt issuance costs was $2.8 million.

The fair value of the Notes was $154.2 million as of December 31, 2015 and was determined using Level 2 inputs based on the indicative pricing published by certain investment banks or trading levels of the Notes, which are not listed on any securities exchange or quoted on an inter-dealer automated quotation system.

Mortgage Loan. In April 2004, Lexicon purchased its existing laboratory and office buildings and animal facilities in The Woodlands, Texas with proceeds from a $34.0 million third-party mortgage financing and $20.8 million in cash.  The mortgage loan originally had a ten-year term with a 20-year amortization and a fixed interest rate of 8.23%. The mortgage was amended in September 2013 to extend the maturity date from April 2014 to April 2017, with the mortgage loan’s monthly payment amount and fixed interest rate each remaining unchanged. The mortgage had a principal balance of $18.3 million as of December 31, 2015. This entire balance was classified as current liabilities on the accompanying consolidated balance sheet as of December 31, 2014 as management intended to repay the mortgage when the assets that serve as collateral for the mortgage loan were sold, and those assets were classified as held for sale as of December 31, 2014. In 2015, these assets were reclassified to assets held and used, and are therefore disclosed as property and equipment as of December 31, 2015, and the related mortgage was reclassified to long-term liabilities, to the extent it is scheduled to be paid after one year, assuming the purchase and sale agreement is not completed (see Note 6, Buildings and Land for Sale). If the purchase and sale agreement that is discussed in Note 6 is completed, the mortgage will be repaid immediately. The buildings and land that serve as collateral for the mortgage loan are included in assets held for sale at $59.1 million and $2.7 million, respectively, before accumulated depreciation, as of December 31, 2015. The fair value of Lexicon’s mortgage loan approximates its carrying value.  The fair value of Lexicon’s mortgage loan was determined using Level 2 inputs using discounted cash flow analysis, based on the Company’s estimated current incremental borrowing rate.


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The following table includes the aggregate scheduled future principal payments of the Company’s long-term debt as of December 31, 2015:
 
 
For the Year Ending
December 31
 
(in thousands)
2016
$
2,015

2017
16,293

2018

2019

2020

Thereafter
87,500

Total debt
105,808

Less current portion
(2,015
)
Total long-term debt
$
103,793


11. Arrangements with Symphony Icon, Inc.
 
On June 15, 2007, Lexicon entered into a series of related agreements providing for the financing of the clinical development of certain of its drug candidates, including telotristat etiprate (LX1032) and LX1033, along with any other pharmaceutical compositions modulating the same targets as those drug candidates (the “Programs”). The agreements included a Novated and Restated Technology License Agreement pursuant to which the Company licensed to Symphony Icon, a then wholly-owned subsidiary of Symphony Icon Holdings LLC (“Holdings”), the Company’s intellectual property rights related to the Programs. Holdings contributed $45 million to Symphony Icon in order to fund the clinical development of the Programs.
Under a Share Purchase Agreement, dated June 15, 2007, between the Company and Holdings, the Company issued and sold to Holdings 1,092,946 shares of its common stock on June 15, 2007 in exchange for $15 million and an exclusive purchase option (the “Purchase Option”) that gave the Company the right to acquire all of the equity of Symphony Icon, thereby allowing the Company to reacquire all of the Programs. On July 30, 2010, Lexicon entered into an Amended and Restated Purchase Option Agreement with Symphony Icon and Holdings and simultaneously exercised the Purchase Option, thereby reacquiring the Programs. Pursuant to the amended terms of the Purchase Option, Lexicon paid Holdings $10 million on July 30, 2010 and issued 1,891,074 shares of common stock to designees of Holdings on July 30, 2012 in satisfaction of an additional $35.0 million base payment obligation.
Lexicon also agreed to make up to $45 million in additional contingent payments, which will consist of 50% of any consideration Lexicon receives pursuant to any licensing transaction (a “Licensing Transaction”) under which Lexicon grants a third party rights to commercialize telotristat etiprate, LX1033 or other pharmaceutical compositions modulating the same target as those drug candidates (the “LG103 Programs”), subject to certain exceptions. The contingent payments will be due if and when Lexicon receives such consideration from a Licensing Transaction. In the event Lexicon receives regulatory approval in the United States for the marketing and sale of any product resulting from the LG103 Programs prior to entering into a Licensing Transaction for the commercialization of such product in the United States, in lieu of any contingent payment from such a Licensing Transaction, Lexicon will pay Holdings the sum of $15 million and the amount of certain expenses Lexicon incurred after its exercise of the Purchase Option which are attributable to the development of such product, reduced by up to 50% of such sum on account of any contingent payments paid prior to such United States regulatory approval attributable to any such Licensing Transaction outside of the United States with respect to such product. In the event Lexicon makes any such payment upon United States regulatory approval, Lexicon will have no obligation to make subsequent contingent payments attributable to any such Licensing Transactions for the commercialization of such product outside the United States until the proceeds of such Licensing Transactions exceed 50% of the payment made as a result of such United States regulatory approval. The contingent payments may be paid in cash or a combination of cash and common stock, in Lexicon’s discretion, provided that no more than 50% of any contingent payment will be paid in common stock. On December 4, 2014, Lexicon paid $5.8 million in cash and issued 666,111 shares of common stock to designees of Holdings in satisfaction of a $11.5 million contingent payment obligation as a result of receiving an upfront payment pursuant to Lexicon’s license and collaboration agreement with Ipsen Pharma SAS. On April 24, 2015, Lexicon paid $0.75 million in cash to Holdings in satisfaction of its contingent payment obligation as a result of receiving an additional upfront payment from Ipsen in March 2015 (see Note 16, Collaboration and License Agreements).


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Lexicon accounted for the exercise of the Purchase Option and acquisition of Symphony Icon as a business combination. In connection with its acquisition of Symphony Icon, Lexicon paid $10.0 million in cash, and has also agreed to pay Holdings additional base and contingent payments as discussed above. The fair value of the base and contingent consideration payments was $45.6 million and was estimated by applying a probability-based income approach utilizing an appropriate discount rate. This estimation was based on significant inputs that are not observable in the market, referred to as Level 3 inputs. Key assumptions include: (1) a discount rate of 14% for the base payments; (2) a discount rate of 18% for the contingent payments; and (3) a probability adjusted contingency. The discount rate assumptions have not changed through December 31, 2015, and as programs progress, the probability adjusted contingency is adjusted as necessary. Subsequent changes in the fair value of the Symphony Icon purchase consideration liability are recorded as increase or decrease in fair value of Symphony Icon purchase liability expense in the accompanying consolidated statements of comprehensive loss. The fair value of the Symphony Icon purchase consideration liability increased by $5.9 million during the year ended December 31, 2015, increased by $1.4 million during the year ended December 31, 2014, and decreased by $2.2 million during the year ended December 31, 2013. In August 2015, Lexicon announced that the pivotal TELESTAR Phase 3 clinical trial met its primary endpoint, showing the benefit of oral telotristat etiprate in treating cancer patients with carcinoid syndrome that is not adequately controlled by the current standard of care. The increase in the contingent purchase liability during the year ended December 31, 2015 reflects a greater likelihood following the top-line results from the TELESTAR trial that the Company will achieve certain milestones with telotristat etiprate, such as regulatory approval, that would trigger payments under the contingent liability.

12. Commitments and Contingencies
 
Operating Lease Obligations:  A Lexicon subsidiary leases office space in Basking Ridge, New Jersey under a lease agreement, the term of which began in June 2015 and terminates in December 2022. Rent expense is recognized on a straight-line basis over the lease term.  Lexicon is the guarantor of the obligations of its subsidiary under this lease agreement.  Under a lease that expired in June 2015, the Company was required to maintain restricted investments to collateralize a standby letter of credit for this lease.  The Company had $0.0 million and $0.4 million in restricted investments as collateral as of December 31, 2015 and 2014, respectively.  Additionally, Lexicon leases certain equipment under operating leases.
 
Rent expense for all operating leases was approximately $0.1 million, $1.0 million and $0.9 million for the years ended December 31, 2015, 2014 and 2013, respectively.  The following table includes non-cancelable, escalating future lease payments for the facility in New Jersey:
 
 
For the Year Ending
December 31
 
(in thousands)
2016
$
512

2017
582

2018
595

2019
607

2020
620

Thereafter
1,277

Total
$
4,193


Employment Arrangements: Lexicon has entered into employment arrangements with certain of its corporate officers. Under the arrangements, each officer receives a base salary, subject to adjustment, with an annual discretionary bonus based upon specific objectives to be determined by the compensation committee. The employment arrangements are at-will and some contain non-competition agreements. Some of the arrangements also provide for certain severance payments for either six or 12 months and, in some cases, payment of a specified portion of the officer’s bonus target for such year, in the event of a specified termination of the officer’s employment.
 
Legal Proceedings:  Lexicon is from time to time party to claims and legal proceedings that arise in the normal course of its business and that it believes will not have, individually or in the aggregate, a material adverse effect on its results of operations, financial condition or liquidity.
 

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13. Other Capital Stock Agreements
 
Common Stock: In November 2014, Lexicon sold 7,944,133 shares of its common stock at a price of $7.035 per share in a public offering, and sold 21,321,961 shares of its common stock at a price of $7.035 per share in a private placement to Artal International S.C.A, an affiliate of Invus, L.P., Lexicon’s largest stockholder, resulting in net proceeds of $201.9 million, after deducting underwriting discounts and commissions of $3.4 million and offering expenses of $0.6 million. All of the net proceeds of these offerings are reflected as issuance of common stock in the accompanying financial statements.

Reverse Stock Split: Effective May 20, 2015, Lexicon completed a one-for-seven reverse split of its common stock. All references to shares of common stock and per-share data for all periods presented in this report have been adjusted to give effect to this reverse stock split. Proportional adjustments were also made to all shares of common stock issuable under Lexicon’s equity incentive plans and upon conversion of Lexicon’s Notes. Concurrent with the reverse stock split, the authorized shares of common stock were reduced from 900 million (prior to the reverse stock split) to 225 million. As no change was made to the par value of the common shares, common stock and additional paid-in capital were adjusted on a retroactive basis to give effect to the reverse stock split. No fractional shares were issued in connection with the reverse stock split. Any fractional share of common stock that would otherwise have resulted from the reverse stock split were converted into cash payments equal to such fraction multiplied by the closing sales price of the common stock as last reported on the last trading day immediately preceding the effective date of the reverse stock split.
 
14. Equity Incentive Awards
 
Equity Incentive Plans
 
Equity Incentive Plan:  In September 1995, Lexicon adopted the 1995 Stock Option Plan, which was subsequently amended and restated in February 2000, April 2009, April 2012 and April 2015 and renamed the Equity Incentive Plan (the “Equity Incentive Plan”).
 
The Equity Incentive Plan provides for the grant of incentive stock options to employees and nonstatutory stock options to employees, directors and consultants of the Company. The plan also permits the grant of stock bonus awards, restricted stock awards, restricted stock unit (phantom stock) awards and stock appreciation rights. Incentive and nonstatutory stock options have an exercise price of 100% or more of the fair market value of our common stock on the date of grant.  The purchase price of restricted stock awards may not be less than 85% of fair market value.  However, the plan administrator may award stock bonus awards in consideration of past services or phantom stock awards without a purchase payment. Shares may be subject to a repurchase option in the discretion of the plan administrator.  Most options granted under the Equity Incentive Plan become vested and exercisable over a period of four years; however some have been granted with different vesting schedules.  Options granted under the Equity Incentive Plan have a term of ten years from the date of grant.
 
The total number of shares of common stock that may be issued pursuant to stock awards under the Equity Incentive Plan shall not exceed in the aggregate 10,000,000 shares.  No more than 3,571,428 shares may be issued pursuant to awards other than stock options and stock appreciation rights.  As of December 31, 2015, an aggregate of 10,000,000 shares of common stock had been reserved for issuance, options to purchase 4,046,758 shares and 636,906 restricted stock units were outstanding, 858,875 shares had been issued upon the exercise of stock options, 626,839 shares had been issued pursuant to restricted stock units and 113,940 shares had been issued pursuant to stock bonus awards or restricted stock awards granted under the Equity Incentive Plan.

Non-Employee Directors’ Equity Incentive Plan:  In February 2000, Lexicon adopted the 2000 Non-Employee Directors’ Stock Option Plan, which was subsequently amended and restated in April 2009, April 2012 and April 2015 and renamed the Non-Employee Directors’ Equity Incentive Plan (the “Directors’ Plan”).  Under the Directors’ Plan, non-employee directors receive an initial option to purchase 4,285 shares of common stock.  In addition, on the day following each of the Company’s annual meetings of stockholders, each non-employee director who has been a director for at least six months is automatically granted an option to purchase 2,857 shares of common stock and a restricted stock award of the number of shares of common stock having a fair market value on the date of grant of $20,000, rounded down to the nearest whole share number.  Initial option grants become vested and exercisable over a period of five years and annual option grants become vested over a period of 12 months from the date of grant.  Options granted under the Directors’ Plan have an exercise price equal to the fair market value of the Company’s common stock on the date of grant and a term of ten years from the date of grant.
 
The total number of shares of common stock that may be issued pursuant to stock awards under the Directors’ Plan shall not exceed in the aggregate 357,142 shares.  As of December 31, 2015, an aggregate of 357,142 shares of common stock

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had been reserved for issuance, options to purchase 169,971 shares were outstanding, none had been issued upon the exercise of stock options and 60,992 shares had been issued pursuant to restricted stock awards granted under the Directors’ Plan.

Stock Option Activity:  The following is a summary of option activity under Lexicon’s equity incentive plans:
 
 
2015
 
2014
 
2013
(in thousands, except exercise price data)
 
Options
 
Weighted Average Exercise Price
 
Options
 
Weighted Average Exercise Price
 
Options
 
Weighted Average Exercise Price
Outstanding at beginning of year
 
3,371

 
$
14.98

 
3,329

 
$
16.94

 
3,075

 
$
17.57

Granted
 
1,207

 
6.83

 
643

 
11.76

 
499

 
14.91

Exercised
 
(19
)
 
11.14

 
(32
)
 
10.22

 
(82
)
 
12.25

Expired
 
(187
)
 
27.29

 
(476
)
 
24.78

 
(136
)
 
27.86

Forfeited
 
(155
)
 
8.51

 
(93
)
 
13.79

 
(27
)
 
13.58

Outstanding at end of year
 
4,217

 
12.35

 
3,371

 
14.98

 
3,329

 
16.94

Exercisable at end of year
 
2,686

 
$
14.53

 
2,417

 
$
15.89

 
2,483

 
$
17.92


The weighted average estimated grant date fair value of options granted during the years ended December 31, 2015, 2014 and 2013 were $4.58, $8.61 and $11.13, respectively.  The total intrinsic value of options exercised during the years ended December 31, 2015, 2014 and 2013 were $35,000, $43,000 and $325,000, respectively.  The weighted average remaining contractual term of options outstanding and exercisable was 6.1 and 4.5 years, respectively, as of December 31, 2015.  At December 31, 2015, the aggregate intrinsic value of the outstanding options and the exercisable options was $10.0 million and $2.4 million, respectively.

Stock Bonus and Restricted Stock Unit Activity:
     
During the years ended December 31, 2015, 2014 and 2013, Lexicon granted its non-employee directors 21,360, 14,651 and 11,544 shares, respectively, of restricted stock awards. The restricted stock awards had weighed average grant date fair values of $7.49, $10.92 and $13.86 per share, respectively, and vested immediately. During the year ended December 31, 2014, Lexicon granted a consultant 8,200 shares of restricted stock awards. The restricted stock awards had a weighted average grant date fair value of $11.20 per share and vested immediately.

During the years ended December 31, 2015, 2014 and 2013, Lexicon granted its employees restricted stock units in lieu of or in addition to annual stock option awards. These restricted stock units vest in four annual installments. The following is a summary of restricted stock units activity under Lexicon’s stock-based compensation plans for the year ended December 31, 2015:
 
 
Shares
 
Weighted Average Grant Date Fair Value
 
 
(in thousands)
 
 
Outstanding at December 31, 2014
 
447

 
$
12.88

Granted
 
452

 
6.23

Vested
 
(166
)
 
12.91

Forfeited
 
(96
)
 
8.98

Nonvested at December 31, 2015
 
637

 
$
8.74


Aggregate Shares Reserved for Issuance
 
As of December 31, 2015, an aggregate of 4,853,635 shares of common stock were reserved for issuance upon exercise of outstanding stock options and vesting of outstanding restricted stock units and 3,842,861 additional shares were available for future grants under Lexicon’s equity incentive plans.  The Company has a policy of using either authorized and unissued shares or treasury shares, including shares acquired by purchase in the open market or in private transactions, to satisfy equity award exercises.
 

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15. Benefit Plan
  
Lexicon maintains a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code.  The plan covers substantially all full-time employees.  Participating employees may defer a portion of their pretax earnings, up to the Internal Revenue Service annual contribution limit.  Beginning in 2000, the Company was required to match employee contributions according to a specified formula.  The matching contributions totaled $332,000, $376,000 and $511,000 in the years ended December 31, 2015, 2014 and 2013, respectively.  Company contributions are vested based on the employee’s years of service, with full vesting after four years of service.

16. Collaboration and License Agreements
 
Lexicon has derived substantially all of its revenues from drug discovery and development alliances, target validation collaborations for the development and, in some cases, analysis of the physiological effects of genes altered in knockout mice, government grants and contracts, technology licenses, subscriptions to its databases and compound library sales.

Sanofi. In November 2015, Lexicon entered into a Collaboration and License Agreement (the “Sanofi Agreement”) with Sanofi for the worldwide development of Lexicon’s drug candidate sotagliflozin (LX4211).

Under the Sanofi Agreement, Lexicon granted Sanofi an exclusive, worldwide, royalty-bearing right and license under its patent rights and know-how to develop, manufacture and commercialize sotagliflozin. Subject to specified exceptions, neither party may (a) perform clinical development activities relating to any other compound which inhibits sodium-glucose cotransporters type 1 or type 2 or (b) commercialize any such compounds in the United States, countries of the European Union and certain other specified countries, in each case during the royalty terms applicable in such countries. Among the specified exceptions is a right Lexicon retained to pursue the development of its LX2761 drug candidate, with respect to which Lexicon granted Sanofi certain rights of first negotiation specified in the Sanofi Agreement.

Under the Sanofi Agreement, Sanofi paid Lexicon an upfront payment of $300 million. In addition, Lexicon is eligible to receive from Sanofi (a) up to an aggregate of $430 million upon the achievement of specified development and regulatory milestones and (b) up to an aggregate of $990 million upon the achievement of specified sales milestones. Due to the uncertainty surrounding the achievement of the future development, regulatory and sales milestones, these payments will not be recognized as revenue unless and until they are earned as the Company is not able to reasonably predict if and when the milestones will be achieved. Lexicon is also entitled to tiered, escalating royalties ranging from low double digit percentages to forty percent of net sales of sotagliflozin, based on indication and territory, with royalties for the higher band of such range attributable to net sales for type 1 diabetes in the United States, and subject in each case to customary royalty reduction provisions. Royalties payable with respect to net sales of sotagliflozin for type 1 diabetes in the United States will also be reduced in the event Lexicon does not exercise its co-promotion option described below.

Lexicon will continue to be responsible for all clinical development activities relating to type 1 diabetes and will retain an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the United States. If Lexicon exercises its co-promotion option, Lexicon will fund forty percent of the commercialization costs relating to such co-promotion activities. Sanofi will be responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide and will be solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the United States. Lexicon will share in the funding of a portion of the planned type 2 diabetes development costs over the next three years, up to an aggregate of $100 million. Sanofi will book sales worldwide in all indications.

The parties are responsible for using commercially reasonable efforts to perform their development and commercialization obligations pursuant to mutually approved development and commercialization plans.

The parties’ activities under the Sanofi Agreement are governed by a joint steering committee and certain other governance committees which reflect equal or other appropriate representation from both parties. If the applicable governance committee is not able to make a decision by consensus and the parties are not able to resolve the issue through escalation to specified senior executive officers of the parties, then Sanofi will have final decision-making authority, subject to limitations specified in the Sanofi Agreement.

The Sanofi Agreement will expire upon the expiration of all applicable royalty terms for all licensed products in all countries. The royalty term for each licensed product in each country is the period commencing on the effective date of the Sanofi Agreement and ending on the latest of expiration of specified patent coverage, expiration of specified regulatory exclusivity and 10 years following the first commercial sale in the applicable country. Either party may terminate the Sanofi

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Agreement in the event of an uncured material breach by the other party. Prior to completion of the core development activities for type 2 diabetes specified in the development plan, Sanofi may terminate the Sanofi Agreement on a country-by-country and licensed product-by-licensed product basis, in the event of (a) notification of a material safety issue relating to the licensed product or the class of sodium-glucose cotransporters type 1 or type 2 inhibitors resulting in a recommendation or requirement that Lexicon or Sanofi cease development, (b) failure to achieve positive results with respect to certain clinical trial results, (c) the occurrence of specified fundamental adverse events or (d) the exploitation of the licensed product infringing third party intellectual property rights in specified major markets and Sanofi is unable to obtain a license to such third party intellectual property rights.

The Company considered the following deliverables with respect to the revenue recognition of the $300 million upfront payment:

The exclusive worldwide license granted to Sanofi to develop and commercialize sotagliflozin;
The development services Lexicon is performing for sotagliflozin relating to type 1 diabetes; and
The funding Lexicon will provide for development relating to type 2 diabetes.

The Company determined that the license had stand-alone value because it is an exclusive license that gives Sanofi the right to develop and commercialize sotagliflozin or to sublicense its rights. In addition, sotagliflozin is currently in development and it is possible that Sanofi or another third party could conduct clinical trials without assistance from Lexicon. As a result, the Company considers the license and the development services under the Sanofi Agreement to be separate units of accounting. The Company recognized the portion of the consideration allocated to the license immediately because Lexicon delivered the license and earned the revenue at the inception of the arrangement. The Company is recognizing as revenue the amount allocated to the development services for type 1 diabetes and the obligation to provide funding for development services for type 2 diabetes over the period of time Lexicon performs services or provides funding, currently expected to be through 2020.

The Company determined that the initial allocable arrangement consideration was the $300 million upfront payment because it was the only payment that was fixed and determinable at the inception of the arrangement. There was considerable uncertainty at the date of the agreement as to whether Lexicon would earn milestone payments or royalty payments. As such, the Company did not include those payments in the allocable consideration. The Company allocated the allocable consideration based on the relative best estimate of selling price of each unit of accounting. The Company estimated the selling price of the license deliverable by applying a probability-based income approach utilizing an appropriate discount rate. The significant inputs the Company used to determine the projected income of the license included: exercising the option to co-promote, estimated future product sales, estimated cost of goods sold, estimated operating expenses, income taxes, and an appropriate discount rate. The Company estimated the selling price of the development services for type 1 diabetes by using internal estimates of the cost to hire third parties to perform the services over the expected period to perform the development. The Company estimated the obligation to provide funding for type 2 diabetes by using internal estimates of the expected cash flows and timing for $100 million in funding.

As a result of the allocation, the Company recognized $126.8 million of the $300 million upfront payment for the license in the year ended December 31, 2015. The Company is recognizing the $113.8 million allocated to the development services deliverable and the $59.4 million allocated to the funding deliverable over the estimated period of performance as the development and funding occurs. Revenue recognized under the Sanofi Agreement was $126.8 million for the year ended December 31, 2015.
 
Ipsen Pharma SAS. In October 2014, Lexicon entered into a License and Collaboration Agreement, which was subsequently amended in March 2015 (collectively, the “Ipsen Agreement”), with Ipsen Pharma SAS (“Ipsen”) for the development and commercialization of Lexicon’s drug candidate telotristat etiprate (LX1032) outside of the United States and Japan (the “Licensed Territory”).

Under the Ipsen Agreement, Lexicon granted Ipsen an exclusive, royalty-bearing right and license under its patent rights and know-how to commercialize telotristat etiprate in the Licensed Territory. Ipsen is responsible for using diligent efforts to commercialize telotristat etiprate in the Licensed Territory pursuant to a mutually approved commercialization plan. Subject to certain exceptions, Lexicon will be responsible for conducting clinical trials required to obtain regulatory approval for telotristat etiprate for carcinoid syndrome in the European Union, including those contemplated by a mutually approved initial development plan, and will have the first right to conduct most other clinical trials of telotristat etiprate. Lexicon is responsible for the costs of all clinical trials contemplated by the initial development plan. The costs of additional clinical trials will be allocated between the parties based on the nature of such clinical trials. Under the Ipsen Agreement, Ipsen has paid Lexicon an aggregate of $24.5 million through December 31, 2015. In addition, Lexicon is eligible to receive from Ipsen (a)

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up to an aggregate of approximately $34 million upon the achievement of specified regulatory and commercial launch milestones and (b) up to an aggregate of €72 million upon the achievement of specified sales milestones. Due to the uncertainty surrounding the achievement of the future regulatory and sales milestones, these payments will not be recognized as revenue unless and until they are earned as the Company is not able to reasonably predict if and when the milestones will be achieved. Lexicon is also entitled to tiered, escalating royalties ranging from low twenties to mid-thirties percentages of net sales of telotristat etiprate in the Licensed Territory, subject to a credit for amounts previously paid to Lexicon by Ipsen for the manufacture and supply of such units of telotristat etiprate. Lexicon’s receipt of these payments under the Ipsen Agreement triggers its obligation to make certain contingent payments to Holdings (see Note 11, Arrangements with Symphony Icon, Inc.). Lexicon and Ipsen will enter into a commercial supply agreement pursuant to which Lexicon will supply Ipsen’s commercial requirements of telotristat etiprate, and Ipsen will pay an agreed upon transfer price for such commercial supply.

The Company considered the following deliverables with respect to the revenue recognition of the $24.5 million upfront payment:

The exclusive license granted to Ipsen to develop and commercialize telotristat etiprate in the Licensed
Territory;
The development services Lexicon is performing for telotristat etiprate;
The obligation to participate in committees which govern the development of telotristat
etiprate until commercialization; and
The obligation to supply commercial supply of telotristat etiprate, under a commercial supply agreement.

The Company determined that the license had stand-alone value because it is an exclusive license that gives Ipsen the right to develop and commercialize telotristat etiprate or to sublicense its rights. In addition, telotristat etiprate is currently in development and it is possible that Ipsen or another third party could conduct clinical trials without assistance from Lexicon. As a result, the Company considers the license and the development services under the Agreement to be separate units of accounting. The Company recognized the portion of the consideration allocated to the license immediately because Lexicon delivered the license and earned the revenue at the inception of the arrangement. The Company is recognizing as revenue the amount allocated to the development services and the obligation to participate in committees over the period of time Lexicon performs services, currently expected to be through mid-2017.

Due to the inherent uncertainty in obtaining regulatory approval, the applicability of the commercial supply agreement is outside the control of Lexicon and Ipsen. Accordingly, the Company has determined the commercial supply agreement is a contingent deliverable at the onset of the Agreement. As a result, the Company has determined the commercial supply agreement does not meet the definition of a deliverable that needs to be accounted for at the inception of the arrangement. The Company has also determined that there is no significant and incremental discount related to the commercial supply agreement that should be accounted for at the inception of the arrangement.

The Company determined that the initial allocable arrangement consideration was the $24.5 million upfront payments because they were the only payments that were fixed and determinable at the inception of the arrangement. There was considerable uncertainty at the date of the agreement as to whether Lexicon would earn milestone payments, royalty payments or payments for finished drug product. As such, the Company did not include those payments in the allocable consideration. The Company allocated the allocable consideration based on the relative best estimate of selling price of each unit of accounting. The Company estimated the selling price of the license deliverable by applying a probability-based income approach utilizing an appropriate discount rate. The significant inputs the Company used to determine the projected income of the license included: estimated future product sales, estimated cost of goods sold, estimated operating expenses, income taxes, and an appropriate discount rate. The Company estimated the selling price of the development services by using internal estimates of the cost to hire third parties to perform the services over the expected period to perform the development. The Company estimated the selling price of the obligation to participate in committees by using internal estimates of the number of internal hours and salary and benefits costs to perform these services.

As a result of the allocation, the Company recognized $21.2 million of the $24.5 million upfront payment for the license in 2014, and an additional $1.4 million in 2015 upon entering into the amendment. The Company is recognizing the $1.7 million allocated to the development services deliverable over the estimated period of performance as development occurs, and is recognizing the $0.1 million allocated to the committee participation deliverable ratably over the estimated period of performance. Revenue recognized under the Agreement was $2.3 million and $21.4 million for the years ended December 31, 2015 and 2014, respectively.
 
Texas Institute for Genomic Medicine.   In July 2005, Lexicon received a $35.0 million award from the Texas Enterprise Fund for the creation of a knockout mouse embryonic stem cell library containing 350,000 cell lines for the Texas

F-22

Table of Contents

Institute for Genomic Medicine (“TIGM”) using Lexicon’s proprietary gene trapping technology, which Lexicon completed in 2007.  Lexicon also equipped TIGM with the bioinformatics software required for the management and analysis of data relating to the library.  The Texas Enterprise Fund also awarded $15.0 million to the Texas A&M University System for the creation of facilities and infrastructure to house the library.  
 
Under the terms of the award, Lexicon is responsible for the creation of a specified number of jobs beginning in 2012, reaching an aggregate of 1,616 new jobs in Texas by December 31, 2016.  Lexicon will obtain credits based on funding received by TIGM and certain related parties from sources other than the State of Texas that it may offset against its potential liability for any job creation shortfalls.  Lexicon will also obtain credits against future jobs commitment liabilities for any surplus jobs it creates.  Subject to these credits, if Lexicon fails to create the specified number of jobs, the state may require Lexicon to repay $2,415 for each job Lexicon falls short beginning in 2013.  Lexicon’s maximum aggregate exposure for such payments, if Lexicon fails to create any new jobs, is approximately $14.2 million, including $6.4 million through 2016, without giving effect to any credits to which Lexicon may be entitled.  Lexicon has recorded this obligation as deferred revenue and accounts payable in the accompanying consolidated balance sheets.  The Texas A&M University System, together with TIGM, has independent job creation obligations and is obligated for an additional period to maintain an aggregate of 5,000 jobs, inclusive of those Lexicon creates.
 
17. Selected Quarterly Financial Data (Unaudited)
 
The table below sets forth certain unaudited statements of comprehensive loss data, and net loss per common share data, for each quarter of 2015 and 2014:
 
(in thousands, except per share data)
 
Quarter Ended
 
March 31
 
June 30
 
September 30
 
December 31
 
 
 
(Unaudited)
 
 
2015
 

 
 

 
 

 
 

Revenues
$
1,792

 
$
376

 
$
566

 
$
127,280

Income (loss) from operations
$
(26,527
)
 
$
(26,688
)
 
$
(33,677
)
 
$
88,360

Consolidated net income (loss)
$
(28,076
)
 
$
(26,074
)
 
$
(35,282
)
 
$
86,750

Consolidated net income (loss) per common share, basic
$
(0.27
)
 
$
(0.27
)
 
$
(0.34
)
 
$
0.84

Consolidated net income (loss) per common share, diluted
(0.27
)
 
(0.27
)
 
(0.34
)
 
0.76

Shares used in computing consolidated net income (loss) per common share, basic
103,516

 
103,608

 
103,616

 
103,623

Shares used in computing consolidated net income (loss) per common share, diluted
103,516

 
103,608

 
103,616

 
115,764

2014
 
 
 
 
 
 
 
Revenues
$
277

 
$
676

 
$
419

 
$
21,482

Loss from operations
$
(30,472
)
 
$
(26,111
)
 
$
(40,336
)
 
$
(3,447
)
Consolidated net loss
$
(30,835
)
 
$
(26,028
)
 
$
(40,498
)
 
$
(2,933
)
Consolidated net loss per common share, basic and diluted
$
(0.42
)
 
$
(0.35
)
 
$
(0.55
)
 
$
(0.03
)
Shares used in computing consolidated net loss per common share, basic and diluted
73,422

 
73,518

 
73,542

 
84,813


For all periods presented other than the quarter ended December 31, 2015, the weighted average number of shares outstanding are the same for both basic and diluted consolidated net loss per common share. For these periods, shares associated with convertible debt, stock options and restricted stock units are not included in the weighted average number of shares of common stock outstanding because they are antidilutive. A reconciliation of the numerator and denominator of basic and diluted earnings per share for the quarter ended December 31, 2015 is presented below (in thousands, expect per share amounts):


F-23

Table of Contents

Consolidated net income, basic
$
86,750

Interest on convertible debt
1,277

Consolidated net income, diluted
$
88,027

 
 
Shares used in computing consolidated net income per common share, basic
103,623

Share-based compensation awards
1,776

Convertible debt
10,365

Shares used in computing consolidated net income per common share, diluted
115,764

 
 
Consolidated net income per common share, basic
$
0.84

Consolidated net income per common share, diluted
$
0.76



F-24

Exhibit


Exhibit 10.8

Summary of Non-Employee Director Compensation

Each non-employee member of our Board of Directors currently receives the following cash compensation:

an annual retainer of $15,000 for service on the Board of Directors ($30,000 for service as non-executive Chairman of the Board of Directors), prorated for any partial year of service;

an annual retainer of $2,500 for service on each committee of the Board of Directors of which he or she is a member ($5,000 for service as chairman of any such committee), prorated for any partial year of service;

a fee of $2,500 for each meeting of the Board of Directors that he or she attends in person ($500 for each telephonic meeting of the Board of Directors in which he or she participates); and

a fee of $1,000 for each committee meeting that he or she attends in person other than in connection with a meeting of the full Board of Directors ($500 for each telephonic committee meeting in which he or she participates).

All directors are reimbursed for expenses in connection with attendance at Board of Directors and committee meetings.

Our Non-Employee Directors’ Equity Incentive Plan provides for the grant of stock options and restricted stock awards to our non-employee directors. Non-employee directors elected for the first time receive an initial option to purchase 4,285 shares of common stock. In addition, all non-employee directors who have served in such capacity for six months receive (a) an annual option to purchase 2,857 shares of common stock and (b) an annual restricted stock award of the number of shares of our common stock having a fair market value on the date of grant of $20,000, rounded down to the nearest whole share number. All stock options granted under the non-employee directors’ plan have an exercise price equal to the fair market value of our common stock on the date of grant.





Exhibit


Exhibit 10.9

LEXICON PHARMACEUTICALS, INC.
EQUITY INCENTIVE PLAN
This Plan initially was established as the Lexicon Genetics Incorporated 1995 Stock Option Plan (the “1995 Stock Option Plan”), which was adopted by the Board and approved by the Company’s stockholders on September 13, 1995. The 1995 Stock Option Plan was subsequently amended and restated in its entirety and renamed the Lexicon Genetics Incorporated 2000 Equity Incentive Plan (the “2000 Equity Incentive Plan”), which was adopted by the Board on February 3, 2000 and approved by the Company’s stockholders on March 15, 2000 and May 19, 2004. The 2000 Equity Incentive Plan was subsequently amended and restated in its entirety and renamed the Equity Incentive Plan (the “Equity Incentive Plan”), which was adopted by the Board on February 27, 2009 and approved by the Company’s stockholders on April 23, 2009. Subsequent amendments to the Equity Incentive Plan were adopted by the Board on February 16, 2012 and February 5, 2015 and approved by the Company’s stockholders on April 26, 2012 and April 23, 2015, respectively. The terms of this Equity Incentive Plan, as amended, shall supersede the terms of the 1995 Stock Option Plan and the 2000 Equity Incentive Plan in their entirety; provided, however, that nothing herein shall operate or be construed as modifying the terms of an Incentive Stock Option granted under the 1995 Stock Option Plan or the 2000 Equity Incentive Plan in a manner that would treat the option as being a new grant for purpose of Section 424(h) of the Code.
1.
PURPOSES.

(a)ELIGIBLE STOCK AWARD RECIPIENTS. The persons eligible to receive Stock Awards are the Employees, Directors and Consultants of the Company and its Affiliates.

(b)AVAILABLE STOCK AWARDS. The purpose of the Plan is to provide a means by which eligible recipients of Stock Awards may be given an opportunity to benefit from increases in value of the Common Stock through the granting of the following Stock Awards: (i) Incentive Stock Options, (ii) Nonstatutory Stock Options, (iii) Stock Bonus Awards, (iv) Restricted Stock Awards, (v) Phantom Stock Awards and (vi) Stock Appreciation Rights.

(c)GENERAL PURPOSE. The Company, by means of the Plan, seeks to retain the services of the group of persons eligible to receive Stock Awards, to secure and retain the services of new members of this group and to provide incentives for such persons to exert maximum efforts for the success of the Company and its Affiliates.

2.
DEFINITIONS.

(a)“AFFILIATE” means any parent corporation or subsidiary corporation of the Company, whether now or hereafter existing, as those terms are defined in Sections 424(e) and (f), respectively, of the Code.

(b)“BOARD” means the Board of Directors of the Company.

(c)“CODE” means the Internal Revenue Code of 1986, as amended.

(d)“COMMITTEE” means a committee of one or more members of the Board appointed by the Board in accordance with subsection 3(c).

(e)“COMMON STOCK” means the common stock, par value $.001 per share, of the Company.

(f)“COMPANY” means Lexicon Pharmaceuticals, Inc. a Delaware corporation.

(g)“CONSULTANT” means any person other than a Director or Employee who is engaged by the Company or an Affiliate to render consulting or advisory services and who is compensated for such services.

(h)“CONTINUOUS SERVICE” means that the Participant’s service with the Company or an Affiliate, whether as an Employee, Director or Consultant, is not interrupted or terminated. The Participant’s Continuous Service shall not be deemed to have terminated merely because of a change in the capacity in which the Participant renders service to the Company or an Affiliate as an Employee, Consultant or Director or a change in the entity for which the Participant renders such service, provided that there is no interruption or termination of the Participant’s Continuous Service. For example, a change in status from an Employee of the Company to a Consultant of an Affiliate or a Director will not constitute an interruption of Continuous Service. The Board or the chief executive officer of the Company, in that party’s sole discretion, may determine whether Continuous Service





shall be considered interrupted in the case of any leave of absence approved by that party, including sick leave, military leave or any other personal leave.

(i)“COVERED EMPLOYEE” means the chief executive officer and the four (4) other highest compensated officers of the Company for whom total compensation is required to be reported to stockholders under the Exchange Act, as determined for purposes of Section 162(m) of the Code.

(j)“DIRECTOR” means a member of the Board of Directors of the Company.

(k)“DISABILITY” means the permanent and total disability of a person within the meaning of Section 22(e)(3) of the Code.

(l)“EMPLOYEE” means any person (which may include a Director) who is employed by the Company or an Affiliate.

(m)“EXCHANGE ACT” means the Securities Exchange Act of 1934, as amended.

(n)“FAIR MARKET VALUE” means, as of any date, the value of the Common Stock determined as follows:

(i)If the Common Stock is listed on any established stock exchange or traded on the Nasdaq Stock Market, the Fair Market Value of a share of Common Stock shall be the closing sales price for such stock (or the closing bid, if no sales were reported) as quoted on such exchange or market (or the exchange or market with the greatest volume of trading in the Common Stock) on the last market trading day prior to the day of determination, as reported in The Wall Street Journal or such other source as the Board deems reliable.

(ii)In the absence of such markets for the Common Stock, the Fair Market Value shall be determined in good faith by the Board in such manner as it deems appropriate and as is consistent with the requirements of section 409A of the Code.

(o)“INCENTIVE STOCK OPTION” means an option to purchase Common Stock that is intended to qualify as an incentive stock option within the meaning of Section 422 of the Code and the regulations promulgated thereunder.

(p)“NON-EMPLOYEE DIRECTOR” means a Director who either (i) is not a current Employee or Officer of the Company or its parent or a subsidiary, does not receive compensation (directly or indirectly) from the Company or its parent for a subsidiary for services rendered as a consultant or in any capacity other than as a Director (except for an amount as to which disclosure would not be required under Item 404(a) of Regulation S-K promulgated pursuant to the Securities Act (“Regulation S-K”)), does not possess an interest in any other transaction as to which disclosure would be required under Item 404(a) of Regulation S-K and is not engaged in a business relationship as to which disclosure would be required under Item 404(b) of Regulation S-K; or (ii) is otherwise considered a “non-employee director” for purposes of Rule 16b-3.

(q)“NONSTATUTORY STOCK OPTION” means an option to purchase Common Stock other than an Incentive Stock Option.

(r)“OFFICER” means a person who is an officer of the Company within the meaning of Section 16 of the Exchange Act and the rules and regulations promulgated thereunder.

(s)“OPTION” means an Incentive Stock Option or a Nonstatutory Stock Option granted pursuant to Section 6 of the Plan.

(t)“OPTION AGREEMENT” means a written agreement between the Company and an Optionholder evidencing the terms and conditions of an individual Option grant. Each Option Agreement shall be subject to the terms and conditions of the Plan.

(u)“OPTIONHOLDER” means a person to whom an Option is granted pursuant to the Plan or, if applicable, such other person who holds an outstanding Option.

(v)“OUTSIDE DIRECTOR” means a Director who either (i) is not a current employee of the Company or an “affiliated corporation” (within the meaning of Treasury Regulations promulgated under Section 162(m) of the Code), is not a former employee of the Company or an “affiliated corporation” receiving compensation for prior services (other than benefits





under a tax qualified pension plan), was not an officer of the Company or an “affiliated corporation” at any time and is not currently receiving direct or indirect remuneration from the Company or an “affiliated corporation” for services in any capacity other than as a Director or (ii) is otherwise considered an “outside director” for purposes of Section 162(m) of the Code.

(w)“PARTICIPANT” means a person to whom a Stock Award is granted pursuant to the Plan or, if applicable, such other person who holds an outstanding Stock Award.

(x)“PHANTOM STOCK AWARD” means a right to receive shares of Common Stock (or the Fair Market Value thereof) granted pursuant to Section 7(c) of the Plan.

(y)“PLAN” means this Lexicon Pharmaceuticals, Inc. Equity Incentive Plan.

(z)“RESTRICTED STOCK AWARD” means a right to purchase restricted Common Stock granted pursuant to Section 7(b) of the Plan.

(aa)“RULE 16B-3” means Rule 16b-3 promulgated under the Exchange Act or any successor to Rule 16b‑3, as in effect from time to time.

(bb)    “SECURITIES ACT” means the Securities Act of 1933, as amended.

(cc)    “STOCK APPRECIATION RIGHT” means a right to receive an amount equal to any appreciation or increase in the Fair Market Value of Common Stock over a specified period of time granted pursuant to Section 7(d) of the Plan.

(dd)    “STOCK AWARD” means any right granted under the Plan, including an Option, a Stock Bonus Award, a Restricted Stock Award, a Phantom Stock Award, or a Stock Appreciation Right.

(ee)    “STOCK AWARD AGREEMENT” means a written agreement between the Company and a holder of a Stock Award evidencing the terms and conditions of an individual Stock Award grant. Each Stock Award Agreement shall be subject to the terms and conditions of the Plan.

(ff)    “STOCK BONUS AWARD” means an award of Common Stock granted pursuant to Section 7(a) of the Plan.

(gg)    “TEN PERCENT STOCKHOLDER” means a person who owns (or is deemed to own pursuant to Section 424(d) of the Code) stock possessing more than ten percent (10%) of the total combined voting power of all classes of stock of the Company or of any of its Affiliates.

3.
ADMINISTRATION.

(a)ADMINISTRATION BY BOARD. The Board shall administer the Plan unless and until the Board delegates administration to a Committee, as provided in subsection 3(c).

(b)POWERS OF BOARD. The Board shall have the power, subject to, and within the limitations of, the express provisions of the Plan:

(i)To determine from time to time which of the persons eligible under the Plan shall be granted Stock Awards; when and how each Stock Award shall be granted; what type or combination of types of Stock Award shall be granted; the provisions of each Stock Award granted (which need not be identical), including the time or times when a person shall be permitted to receive Common Stock pursuant to a Stock Award; and the number of shares of Common Stock with respect to which a Stock Award shall be granted to each such person.

(ii)To construe and interpret the Plan and Stock Awards granted under it, and to establish, amend and revoke rules and regulations for its administration. The Board, in the exercise of this power, may correct any defect, omission or inconsistency in the Plan or in any Stock Award Agreement, in a manner and to the extent it shall deem necessary or expedient to make the Plan fully effective.

(iii)To amend the Plan or a Stock Award as provided in Section 12.

(iv)To terminate or suspend the Plan as provided in Section 13.






(v)Generally, to exercise such powers and to perform such acts as the Board deems necessary or expedient to promote the best interests of the Company that are not in conflict with the provisions of the Plan.

(c)DELEGATION TO COMMITTEE.

(i)GENERAL. The Board may delegate administration of the Plan to a Committee or Committees of one (1) or more members of the Board, and the term “Committee” shall apply to any person or persons to whom such authority has been delegated. If administration is delegated to a Committee, the Committee shall have, in connection with the administration of the Plan, the powers theretofore possessed by the Board, including the power to delegate to a subcommittee any of the administrative powers the Committee is authorized to exercise (and references in this Plan to the Board shall thereafter be to the Committee or subcommittee), subject, however, to such resolutions, not inconsistent with the provisions of the Plan, as may be adopted from time to time by the Board. The Board may abolish the Committee at any time and revest in the Board the administration of the Plan.

(ii)COMMITTEE COMPOSITION WHEN COMMON STOCK IS PUBLICLY TRADED. At such time as the Common Stock is publicly traded, in the discretion of the Board, a Committee may consist solely of two or more Outside Directors, in accordance with Section 162(m) of the Code, and/or solely of two or more Non-Employee Directors, in accordance with Rule 16b-3. Within the scope of such authority, the Board or the Committee may (A) delegate to a committee of one or more members of the Board who are not Outside Directors the authority to grant Stock Awards to eligible persons who are either (1) not then Covered Employees and are not expected to be Covered Employees at the time of recognition of income resulting from such Stock Award or (2) not persons with respect to whom the Company wishes to comply with Section 162(m) of the Code, and/or (B) delegate to a committee of one or more members of the Board who are not Non-Employee Directors the authority to grant Stock Awards to eligible persons who are not then subject to Section 16 of the Exchange Act.

(d)EFFECT OF BOARD’S DECISION. All determinations, interpretations and constructions made by the Board in good faith shall not be subject to review by any person and shall be final, binding and conclusive on all persons.

4.
SHARES SUBJECT TO THE PLAN.

(a)SHARE RESERVE. Subject to the provisions of Section 11 relating to adjustments upon changes in Common Stock, the Common Stock that may be issued pursuant to Stock Awards shall not exceed in the aggregate ten million (10,000,000) shares.

(b)REVERSION OF SHARES TO THE SHARE RESERVE. If any Stock Award shall for any reason expire or otherwise terminate, in whole or in part, without having been exercised in full or shares of Common Stock issued to a Participant pursuant to a Stock Award are forfeited to or repurchased by the Company, including any repurchase or forfeiture caused by the failure to meet a contingency or condition required for the vesting of such shares, the shares of Common Stock not issued under such Stock Award or forfeited to or repurchased by the Company shall revert to and again become available for issuance under the Plan; provided, however, that shares subject to a Stock Award that are not delivered to a Participant because (i) such Participant’s right to purchase such shares subject to an Option are surrendered in payment of the exercise price for other shares subject to such Option in a “net exercise,” or (ii) such shares are withheld in satisfaction of the withholding of taxes incurred in connection with the exercise of an Option or Stock Appreciation Right, or the issuance of shares under a Stock Bonus Award, Restricted Stock Award or Phantom Stock Award, the shares so surrendered or withheld shall not remain available for subsequent issuance under the Plan.

(c)SOURCE OF SHARES. The shares of Common Stock subject to the Plan may be unissued shares or reacquired shares, bought on the market or otherwise.

(d)SHARES AVAILABLE FOR SPECIFIC STOCK AWARDS. Subject to the provisions of Section 11 relating to adjustments upon changes in the shares of Common Stock, the Common Stock that may be issued pursuant to Stock Awards other than Options and Stock Appreciation Rights shall not exceed in the aggregate three million five hundred seventy one thousand four hundred twenty eight (3,571,428) shares.

5.
ELIGIBILITY.

(a)ELIGIBILITY FOR SPECIFIC STOCK AWARDS. Incentive Stock Options may be granted only to Employees. Stock Awards other than Incentive Stock Options may be granted to Employees, Directors and Consultants.






(b)TEN PERCENT STOCKHOLDERS. A Ten Percent Stockholder shall not be granted an Incentive Stock Option unless the exercise price of such Option is at least one hundred ten percent (110%) of the Fair Market Value of the Common Stock at the date of grant and the Option is not exercisable after the expiration of five (5) years from the date of grant.

(c)SECTION 162(m) LIMITATION. Subject to the provisions of Section 11 relating to adjustments upon changes in the shares of Common Stock, no Employee shall be eligible to be granted Options covering more than four hundred twenty eight thousand five hundred seventy one (428,571) shares during any calendar year.

6.
OPTION PROVISIONS.

Each Option shall be in such form and shall contain such terms and conditions as the Board shall deem appropriate. All Options shall be separately designated Incentive Stock Options or Nonstatutory Stock Options at the time of grant, and, if certificates are issued, a separate certificate or certificates will be issued for shares of Common Stock purchased on exercise of each type of Option. The provisions of separate Options need not be identical, but each Option shall include (through incorporation of provisions hereof by reference in the Option or otherwise) the substance of each of the following provisions:
(a)TERM. Subject to the provisions of subsection 5(b) regarding Ten Percent Stockholders, no Option shall be exercisable after the expiration of ten (10) years from the date it was granted.

(b)EXERCISE PRICE. Subject to the provisions of subsection 5(b) regarding Ten Percent Stockholders, the exercise price of each Option shall be not less than one hundred percent (100%) of the Fair Market Value of the Common Stock subject to the Option on the date the Option is granted. Notwithstanding the foregoing, an Option may be granted with an exercise price lower than that set forth in the preceding sentence if such Option is granted pursuant to an assumption or substitution for another option in a manner satisfying the provisions of Section 424(a) of the Code.

(c)CONSIDERATION. The purchase price of Common Stock acquired pursuant to an Option shall be paid, to the extent permitted by applicable statutes and regulations, either (i) in cash at the time the Option is exercised or (ii) at the discretion of the Board (1) by delivery to the Company of other Common Stock, (2) according to a deferred payment or other similar arrangement with the Optionholder, (3) by surrender of Optionholder’s right to purchase shares subject to an Option (valued, for such purposes, as the Fair Market Value of such surrendered shares on the date of exercise less the exercise price for such surrendered shares) in payment of the exercise price for other shares subject to such Option in a “net exercise” of such Option, or (4) in any other form of legal consideration that may be acceptable to the Board. At any time that the Company is incorporated in Delaware, payment of the Common Stock’s “par value,” as defined in the Delaware General Corporation Law, shall not be made by deferred payment. In the case of any deferred payment arrangement, interest shall be compounded at least annually and shall be charged at the minimum rate of interest necessary to avoid the treatment as interest, under any applicable provisions of the Code, of any amounts other than amounts stated to be interest under the deferred payment arrangement.

(d)TRANSFERABILITY. An Incentive Stock Option shall not be transferable except by will or by the laws of descent and distribution and shall be exercisable during the lifetime of the Optionholder only by the Optionholder. A Nonstatutory Stock Option shall be transferable to the extent provided in the Option Agreement; provided that, if the Nonstatutory Stock Option does not provide for transferability, then the Nonstatutory Stock Option shall not be transferable except by will or by the laws of descent and distribution and shall be exercisable during the lifetime of the Optionholder only by the Optionholder. Notwithstanding the foregoing, the Optionholder may, by delivering written notice to the Company, in a form satisfactory to the Company, designate a third party who, in the event of the death of the Optionholder, shall thereafter be entitled to exercise the Option.

(e)VESTING GENERALLY. The total number of shares of Common Stock subject to an Option may, but need not, vest and therefore become exercisable in periodic installments that may, but need not, be equal. The Option may be subject to such other terms and conditions on the time or times when it may be exercised (which may be based on performance or other criteria) as the Board may deem appropriate. The vesting provisions of individual Options may vary.

(f)TERMINATION OF CONTINUOUS SERVICE. In the event an Optionholder’s Continuous Service terminates (other than upon the Optionholder’s death or Disability), the Optionholder may exercise his or her Option (to the extent that the Optionholder was entitled to exercise such Option as of the date of termination) but only within such period of time ending on the earlier of (i) the date three (3) months following the termination of the Optionholder’s Continuous Service (or such longer or shorter period specified in the Option Agreement), or (ii) the expiration of the term of the Option as set forth in the Option Agreement. If, after termination, the Optionholder does not exercise his or her Option within the time specified in the Option Agreement, the Option shall terminate.






(g)EXTENSION OF TERMINATION DATE. An Optionholder’s Option Agreement may also provide that if the exercise of the Option following the termination of the Optionholder’s Continuous Service (other than upon the Optionholder’s death or Disability) would be prohibited at any time solely because the issuance of shares of Common Stock would violate the registration requirements under the Securities Act, then the Option shall terminate on the earlier of (i) the expiration of the term of the Option set forth in subsection 6(a) or (ii) the expiration of a period of three (3) months after the termination of the Optionholder’s Continuous Service during which the exercise of the Option would not be in violation of such registration requirements.

(h)DISABILITY OF OPTIONHOLDER. In the event that an Optionholder’s Continuous Service terminates as a result of the Optionholder’s Disability, the Optionholder may exercise his or her Option (to the extent that the Optionholder was entitled to exercise such Option as of the date of termination), but only within such period of time ending on the earlier of (i) the date twelve (12) months following such termination (or such longer or shorter period specified in the Option Agreement,) or (ii) the expiration of the term of the Option as set forth in the Option Agreement. If, after termination, the Optionholder does not exercise his or her Option within the time specified herein, the Option shall terminate.

(i)DEATH OF OPTIONHOLDER. In the event (i) an Optionholder’s Continuous Service terminates as a result of the Optionholder’s death or (ii) the Optionholder dies within the period (if any) specified in the Option Agreement after the termination of the Optionholder’s Continuous Service for a reason other than death, then the Option may be exercised (to the extent the Optionholder was entitled to exercise such Option as of the date of death) by the Optionholder’s estate, by a person who acquired the right to exercise the Option by bequest or inheritance or by a person designated to exercise the Option upon the Optionholder’s death pursuant to subsection 6(d), but only within the period ending on the earlier of (1) the date eighteen (18) months following the date of death (or such longer or shorter period specified in the Option Agreement) or (2) the expiration of the term of such Option as set forth in the Option Agreement. If, after death, the Option is not exercised within the time specified herein, the Option shall terminate.

7.
PROVISIONS OF STOCK AWARDS OTHER THAN OPTIONS.

(a)STOCK BONUS AWARDS. Each Stock Bonus Award agreement shall be in such form and shall contain such terms and conditions as the Board shall deem appropriate. The terms and conditions of Stock Bonus Award agreements may change from time to time, and the terms and conditions of separate Stock Bonus Award agreements need not be identical, but each Stock Bonus Award agreement shall include (through incorporation of provisions hereof by reference in the agreement or otherwise) the substance of each of the following provisions:

(i)CONSIDERATION. A Stock Bonus Award may be granted in consideration for past services actually rendered to the Company or an Affiliate for its benefit.

(ii)VESTING. Shares of Common Stock awarded under the Stock Bonus Award agreement may, but need not, be subject to a share repurchase option or forfeiture restrictions in favor of the Company in accordance with a vesting schedule to be determined by the Board.

(iii)TERMINATION OF PARTICIPANT’S CONTINUOUS SERVICE. In the event a Participant’s Continuous Service terminates, the Company may reacquire any or all of the shares of Common Stock held by the Participant which have not vested as of the date of termination under the terms of the Stock Bonus Award agreement.

(iv)TRANSFERABILITY. Rights to acquire shares of Common Stock under the Stock Bonus Award agreement shall be transferable by the Participant only upon such terms and conditions as are set forth in the Stock Bonus Award agreement, as the Board shall determine in its discretion, so long as Common Stock awarded under the Stock Bonus Award agreement remains subject to the terms of the Stock Bonus Award agreement.

(b)RESTRICTED STOCK AWARDS. Each Restricted Stock Award agreement shall be in such form and shall contain such terms and conditions as the Board shall deem appropriate. The terms and conditions of the Restricted Stock Award agreement may change from time to time, and the terms and conditions of separate Restricted Stock Award agreements need not be identical, but each Restricted Stock Award agreement shall include (through incorporation of provisions hereof by reference in the agreement or otherwise) the substance of each of the following provisions:

(i)PURCHASE PRICE. The purchase price under each Restricted Stock Award agreement shall be such amount as the Board shall determine and designate in such Restricted Stock Award agreement. Such purchase price shall not be less than eighty-five percent (85%) of the Common Stock’s Fair Market Value on the date such award is made or at the time the purchase is consummated.






(ii)CONSIDERATION. The purchase price of Common Stock acquired pursuant to the Restricted Stock Award agreement shall be paid either: (A) in cash at the time of purchase; (B) at the discretion of the Board, according to a deferred payment or other similar arrangement with the Participant; or (C) in any other form of legal consideration that may be acceptable to the Board in its discretion; provided, however, that at any time that the Company is incorporated in Delaware, then payment of the Common Stock’s “par value,” as defined in the Delaware General Corporation Law, shall not be made by deferred payment.

(iii)VESTING. Shares of Common Stock acquired under the Restricted Stock Award agreement may, but need not, be subject to a share repurchase option in favor of the Company in accordance with a vesting schedule to be determined by the Board.

(iv)TERMINATION OF PARTICIPANT’S CONTINUOUS SERVICE. In the event a Participant’s Continuous Service terminates, the Company may repurchase or otherwise reacquire any or all of the shares of Common Stock held by the Participant which have not vested as of the date of termination under the terms of the Restricted Stock Award agreement.

(v)TRANSFERABILITY. Rights to acquire shares of Common Stock under the Restricted Stock Award agreement shall be transferable by the Participant only upon such terms and conditions as are set forth in the Restricted Stock Award agreement, as the Board shall determine in its discretion, so long as Common Stock awarded under the Restricted Stock Award agreement remains subject to the terms of the Restricted Stock Award agreement.

(c)PHANTOM STOCK AWARDS. Each Phantom Stock Award agreement shall be in such form and shall contain such terms and conditions as the Board shall deem appropriate. The terms and conditions of Phantom Stock Award agreements may change from time to time, and the terms and conditions of separate Phantom Stock Award agreements need not be identical, provided, however, that each Phantom Stock Award agreement shall include (through incorporation of the provisions hereof by reference in the agreement or otherwise) the substance of each of the following provisions:

(i)CONSIDERATION. At the time of grant of a Phantom Stock Award, the Board will determine the consideration, if any, to be paid by the Participant upon delivery of each share of Common Stock subject to the Phantom Stock Award. The consideration to be paid (if any) by the Participant for each share of Common Stock subject to a Phantom Stock Award may be paid in any form of legal consideration that may be acceptable to the Board in its sole discretion and permissible under applicable law.

(ii)VESTING. At the time of the grant of a Phantom Stock Award, the Board may impose such restrictions or conditions to the vesting of the Phantom Stock Award as it, in its sole discretion, deems appropriate.

(iii)PAYMENT. A Phantom Stock Award may be settled by the delivery of shares of Common Stock, their cash equivalent, any combination thereof or in any other form of consideration, as determined by the Board and contained in the Phantom Stock Award agreement.

(iv)DIVIDEND EQUIVALENTS. Dividend equivalents may be credited in respect of shares of Common Stock covered by a Phantom Stock Award, as determined by the Board and contained in the Phantom Stock Award agreement. At the sole discretion of the Board, such dividend equivalents may be converted into additional shares of Common Stock covered by the Phantom Stock Award in such manner as determined by the Board. Any additional shares covered by the Phantom Stock Award credited by reason of such dividend equivalents will be subject to all the terms and conditions of the underlying Phantom Stock Award agreement to which they relate.

(v)TERMINATION OF PARTICIPANT’S CONTINUOUS SERVICE. Except as otherwise provided in the applicable Phantom Stock Award agreement, such portion of the Phantom Stock Award that has not vested will be forfeited upon the Participant’s termination of Continuous Service.

(vi)TRANSFERABILITY. Rights under the Phantom Stock Award agreement shall be transferable by the Participant only upon such terms and conditions as are set forth in the Phantom Stock Award agreement, as the Board shall determine in its discretion.

(d)STOCK APPRECIATION RIGHTS. Each Stock Appreciation Right agreement shall be in such form and shall contain such terms and conditions as the Board shall deem appropriate. The terms and conditions of the Stock Appreciation Right agreements may change from time to time, and the terms and conditions of separate Stock Appreciation Right agreements need





not be identical, but each Stock Appreciation Right agreement shall include (through incorporation of provisions hereof by reference in the agreement or otherwise) the substance of each of the following provisions:

(i)CALCULATION OF APPRECIATION. Each Stock Appreciation Right will be denominated in shares of Common Stock equivalents. The appreciation distribution payable on the exercise of a Stock Appreciation Right will be not greater than an amount equal to the excess of (i) the aggregate Fair Market Value (on the date of the exercise of the Stock Appreciation Right) of a number of shares of Common Stock equal to the number of shares of Common Stock equivalents in which the Participant is vested under such Stock Appreciation Right, and with respect to which the Participant is exercising the Stock Appreciation Right on such date, over (ii) an amount (the strike price) that will be determined by the Board at the time of grant of the Stock Appreciation Right for such number of shares of Common Stock, provided that the strike price of a Stock Appreciation Right shall be not less than one hundred percent (100%) of the Fair Market Value of the Common Stock equal to the number of shares of Common Stock equivalents subject to the Stock Appreciation Right on the date the Stock Appreciation Right is granted.

(ii)VESTING. At the time of the grant of a Stock Appreciation Right, the Board may impose such restrictions or conditions to the vesting of such Stock Appreciation Right as it, in its sole discretion, deems appropriate.

(iii)EXERCISE. To exercise any outstanding Stock Appreciation Right, the Participant must provide written notice of exercise to the Company in compliance with the provisions of the Stock Appreciation Right agreement evidencing such Stock Appreciation Right.

(iv)PAYMENT. The appreciation distribution in respect to a Stock Appreciation Right may be paid in cash, shares of Common Stock, a combination of cash and shares of Common Stock or in any other form of consideration, as determined by the Board and contained in the Stock Appreciation Right agreement evidencing such Stock Appreciation Right.

(v)TERMINATION OF PARTICIPANT’S CONTINUOUS SERVICE. In the event that a Participant’s Continuous Service terminates, the Participant may exercise his or her Stock Appreciation Right (to the extent that the Participant was entitled to exercise such Stock Appreciation Right as of the date of termination) but only within such period of time ending on the earlier of (i) the date three (3) months following the termination of the Participant’s Continuous Service (or such longer or shorter period specified in the Stock Appreciation Right agreement), or (ii) the expiration of the term of the Stock Appreciation Right as set forth in the Stock Appreciation Right agreement. If, after termination, the Participant does not exercise his or her Stock Appreciation Right within the time specified herein or in the Stock Appreciation Right agreement (as applicable), the Stock Appreciation Right shall terminate.

(vi)TRANSFERABILITY. Rights under the Stock Appreciation Right agreement shall be transferable by the Participant only upon such terms and conditions as are set forth in the Stock Appreciation Right agreement, as the Board shall determine in its discretion.

8.
COVENANTS OF THE COMPANY.

(a)AVAILABILITY OF SHARES. During the terms of the Stock Awards, the Company shall keep available at all times the number of shares of Common Stock required to satisfy such Stock Awards.

(b)SECURITIES LAW COMPLIANCE. The Company shall seek to obtain from each regulatory commission or agency having jurisdiction over the Plan such authority as may be required to grant Stock Awards and to issue and sell shares of Common Stock upon exercise of the Stock Awards; provided, however, that this undertaking shall not require the Company to register under the Securities Act the Plan, any Stock Award or any Common Stock issued or issuable pursuant to any such Stock Award. If, after reasonable efforts, the Company is unable to obtain from any such regulatory commission or agency the authority which counsel for the Company deems necessary for the lawful issuance and sale of Common Stock under the Plan, the Company shall be relieved from any liability for failure to issue and sell Common Stock upon exercise of such Stock Awards unless and until such authority is obtained.

9.
USE OF PROCEEDS FROM STOCK.

Proceeds from the sale of Common Stock pursuant to Stock Awards shall constitute general funds of the Company.






10.
MISCELLANEOUS.

(a)ACCELERATION OF EXERCISABILITY AND VESTING. The Board shall have the power to accelerate the time at which a Stock Award may first be exercised or the time during which a Stock Award or any part thereof will vest in accordance with the Plan, notwithstanding the provisions in the Stock Award stating the time at which it may first be exercised or the time during which it will vest.

(b)STOCKHOLDER RIGHTS. No Participant shall be deemed to be the holder of, or to have any of the rights of a holder with respect to, any shares of Common Stock subject to such Stock Award unless and until such Participant has satisfied all requirements for exercise of the Stock Award pursuant to its terms.

(c)NO EMPLOYMENT OR OTHER SERVICE RIGHTS. Nothing in the Plan or any instrument executed or Stock Award granted pursuant thereto shall confer upon any Participant any right to continue to serve the Company or an Affiliate in the capacity in effect at the time the Stock Award was granted or shall affect the right of the Company or an Affiliate to terminate (i) the employment of an Employee with or without notice and with or without cause, (ii) the service of a Consultant pursuant to the terms of such Consultant’s agreement with the Company or an Affiliate or (iii) the service of a Director pursuant to the Bylaws of the Company or an Affiliate, and any applicable provisions of the corporate law of the state in which the Company or the Affiliate is incorporated, as the case may be.

(d)INCENTIVE STOCK OPTION $100,000 LIMITATION. To the extent that the aggregate Fair Market Value (determined at the time of grant) of Common Stock with respect to which Incentive Stock Options are exercisable for the first time by any Optionholder during any calendar year (under all plans of the Company and its Affiliates) exceeds one hundred thousand dollars ($100,000), the Options or portions thereof which exceed such limit (according to the order in which they were granted) shall be treated as Nonstatutory Stock Options.

(e)INVESTMENT ASSURANCES. The Company may require a Participant, as a condition of exercising or acquiring Common Stock under any Stock Award, (i) to give written assurances satisfactory to the Company as to the Participant’s knowledge and experience in financial and business matters and/or to employ a purchaser representative reasonably satisfactory to the Company who is knowledgeable and experienced in financial and business matters and that he or she is capable of evaluating, alone or together with the purchaser representative, the merits and risks of exercising the Stock Award; and (ii) to give written assurances satisfactory to the Company stating that the Participant is acquiring Common Stock subject to the Stock Award for the Participant’s own account and not with any present intention of selling or otherwise distributing the Common Stock. The foregoing requirements, and any assurances given pursuant to such requirements, shall be inoperative if (1) the issuance of the shares of Common Stock upon the exercise or acquisition of Common Stock under the Stock Award has been registered under a then currently effective registration statement under the Securities Act or (2) as to any particular requirement, a determination is made by counsel for the Company that such requirement need not be met in the circumstances under the then applicable securities laws. The Company may, upon advice of counsel to the Company, place legends on stock certificates issued under the Plan as such counsel deems necessary or appropriate in order to comply with applicable securities laws, including, but not limited to, legends restricting the transfer of the Common Stock.

(f)WITHHOLDING OBLIGATIONS. To the extent provided by the terms of a Stock Award Agreement, the Participant may satisfy any federal, state or local tax withholding obligation relating to the exercise or acquisition of Common Stock under a Stock Award by any of the following means (in addition to the Company’s right to withhold from any compensation paid to the Participant by the Company) or by a combination of such means: (i) tendering a cash payment; (ii) authorizing the Company to withhold shares of Common Stock from the shares of Common Stock otherwise issuable to the Participant as a result of the exercise or acquisition of Common Stock under the Stock Award, provided, however, that no shares of Common Stock are withheld with a value exceeding the minimum amount of tax required to be withheld by law; or (iii) delivering to the Company owned and unencumbered shares of Common Stock.

11.
ADJUSTMENTS UPON CHANGES IN STOCK.

(a)CAPITALIZATION ADJUSTMENTS. If any change is made in the Common Stock subject to the Plan, or subject to any Stock Award, without the receipt of consideration by the Company (through merger, consolidation, reorganization, recapitalization, reincorporation, stock dividend, dividend in property other than cash, stock split, liquidating dividend, combination of shares, exchange of shares, change in corporate structure or other transaction not involving the receipt of consideration by the Company), the Plan will be appropriately adjusted in the class(es) and the number of securities subject to the Plan pursuant to subsection 4(a), the maximum number of securities subject to Stock Awards other than Options and Stock Appreciation Rights pursuant to subsection 4(d), the maximum number of securities subject to award to any person pursuant to subsection 5(c), and the outstanding Stock Awards will be appropriately adjusted in the class(es) and number of securities and price per share of Common





Stock subject to such outstanding Stock Awards. The Board shall make such adjustments, and its determination shall be final, binding and conclusive. For clarity, the conversion of any convertible securities of the Company shall not be treated as a transaction “without receipt of consideration” by the Company.

(b)DISSOLUTION OR LIQUIDATION. In the event of a dissolution or liquidation of the Company, then all outstanding Stock Awards shall terminate immediately prior to such event.

(c)ASSET SALE, MERGER, CONSOLIDATION OR REVERSE MERGER. In the event of (i) a sale, lease or other disposition of all or substantially all of the assets of the Company, (ii) a merger or consolidation in which the Company is not the surviving corporation or (iii) a reverse merger in which the Company is the surviving corporation but the shares of Common Stock outstanding immediately preceding the merger are converted by virtue of the merger into other property, whether in the form of securities, cash or otherwise, then any surviving corporation or acquiring corporation shall assume any Stock Awards outstanding under the Plan or shall substitute similar stock awards (including an award to acquire the same consideration paid to the stockholders in the transaction described in this subsection 11(c) for those outstanding under the Plan). In the event any surviving corporation or acquiring corporation fails to assume such Stock Awards or to substitute similar stock awards for those outstanding under the Plan, then with respect to Stock Awards held by Participants whose Continuous Service has not terminated, the vesting of such Stock Awards (and, if applicable, the time during which such Stock Awards may be exercised) shall be accelerated in full, and the Stock Awards shall terminate if not exercised (if applicable) at or prior to such event. With respect to any other Stock Awards outstanding under the Plan, such Stock Awards shall terminate if not exercised (if applicable) prior to such event.

12.
AMENDMENT OF THE PLAN AND STOCK AWARDS.

(a)AMENDMENT OF PLAN. The Board at any time, and from time to time, may amend the Plan. However, except as provided in Section 11 relating to adjustments upon changes in Common Stock, no amendment shall be effective unless approved by the stockholders of the Company to the extent stockholder approval is necessary to satisfy the requirements of Section 422 of the Code, Rule 16b-3 or any Nasdaq or securities exchange listing requirements.

(b)STOCKHOLDER APPROVAL. The Board may, in its sole discretion, submit any other amendment to the Plan for stockholder approval, including, but not limited to, amendments to the Plan intended to satisfy the requirements of Section 162(m) of the Code and the regulations thereunder regarding the exclusion of performance-based compensation from the limit on corporate deductibility of compensation paid to certain executive officers.

(c)CONTEMPLATED AMENDMENTS. It is expressly contemplated that the Board may amend the Plan in any respect the Board deems necessary or advisable to provide eligible Employees with the maximum benefits provided or to be provided under the provisions of the Code and the regulations promulgated thereunder relating to Incentive Stock Options and/or to bring the Plan and/or Incentive Stock Options granted under it into compliance therewith.

(d)NO IMPAIRMENT OF RIGHTS. Rights under any Stock Award granted before amendment of the Plan shall not be impaired by any amendment of the Plan unless (i) the Company requests the consent of the Participant and (ii) the Participant consents in writing.

(e)AMENDMENT OF STOCK AWARDS. The Board at any time, and from time to time, may amend the terms of any one or more Stock Awards; provided, however, that the rights under any Stock Award shall not be impaired by any such amendment unless (i) the Company requests the consent of the Participant and (ii) the Participant consents in writing.

13.
TERMINATION OR SUSPENSION OF THE PLAN.

(a)PLAN TERM. The Board may suspend or terminate the Plan at any time. Unless sooner terminated, the Plan shall terminate on the day before the tenth (10th) anniversary of the date the Plan is adopted by the Board or approved by the stockholders of the Company, whichever is earlier. No Stock Awards may be granted under the Plan while the Plan is suspended or after it is terminated.

(b)NO IMPAIRMENT OF RIGHTS. Suspension or termination of the Plan shall not impair rights and obligations under any Stock Award granted while the Plan is in effect except with the written consent of the Participant.






14.
EFFECTIVE DATE OF PLAN.

The Plan shall become effective upon its adoption by the Board, but no Stock Award shall be exercised (or, in the case of a stock bonus, shall be granted) unless and until the Plan has been approved by the stockholders of the Company, which approval shall be within twelve (12) months before or after the date the Plan is adopted by the Board.
15.
CHOICE OF LAW.

The law of the State of Delaware shall govern all questions concerning the construction, validity and interpretation of this Plan, without regard to such state’s conflict of laws rules.




Exhibit


Exhibit 10.10

LEXICON PHARMACEUTICALS, INC.
NON-EMPLOYEE DIRECTORS’ EQUITY INCENTIVE PLAN

This Plan initially was established as the 2000 Non-Employee Directors’ Stock Option Plan, effective as of April 12, 2000 (the “2000 Non-Employee Directors’ Stock Option Plan”) which was adopted by the Board on February 3, 2000 and approved by the Company’s stockholders on March 15, 2000. A subsequent amendment to the 2000 Non-Employee Directors’ Stock Option Plan was approved by the Board on February 2, 2005 and approved by the Company’s stockholders on April 27, 2005. The 2000 Non-Employee Directors’ Stock Option Plan was subsequently amended and restated in its entirety and renamed the Non-Employee Directors’ Stock Option Plan (the “Non-Employee Directors’ Stock Option Plan”), which was adopted by the Board on February 27, 2009 and approved by the Company’s stockholders on April 23, 2009. A subsequent amendment to the Non-Employee Directors’ Stock Option Plan pursuant to which it was renamed the Non-Employee Directors’ Equity Incentive Plan (the “Non-Employee Directors’ Equity Incentive Plan”) was adopted by the Board on February 16, 2012 and approved by the Company’s stockholders on April 26, 2012. A subsequent amendment to the Non-Employee Directors’ Equity Incentive Plan was adopted by the Board on February 5, 2015 and approved by the Company’s stockholders on April 23, 2015. The terms of this Non-Employee Directors’ Equity Incentive Plan, as amended, shall supersede the terms of the 2000 Non-Employee Directors’ Stock Option Plan and Non-Employee Directors’ Stock Option Plan in their entirety.

1.    PURPOSES.

(a)    ELIGIBLE STOCK AWARD RECIPIENTS. The persons eligible to receive Stock Awards are the Non-Employee Directors of the Company.

(b)    AVAILABLE STOCK AWARDS. The purpose of the Plan is to provide a means by which Non-Employee Directors may be given an opportunity to benefit from increases in value of the Common Stock through the granting of the following Stock Awards: (i) Nonstatutory Stock Options and (ii) Restricted Stock Awards.

(c)    GENERAL PURPOSE. The Company, by means of the Plan, seeks to retain the services of its Non-Employee Directors, to secure and retain the services of new Non-Employee Directors and to provide incentives for such persons to exert maximum efforts for the success of the Company and its Affiliates.

2.    DEFINITIONS.

(a)    “AFFILIATE” means any parent corporation or subsidiary corporation of the Company, whether now or hereafter existing, as those terms are defined in Sections 424(e) and (f), respectively, of the Code.

(b)    “ANNUAL GRANT” means an Option and Restricted Stock Award granted annually to all Non-Employee Directors who meet the specified criteria pursuant to subsection 6(b) of the Plan.

(c)    “ANNUAL MEETING” means the annual meeting of the stockholders of the Company.

(d)    “BOARD” means the Board of Directors of the Company.

(e)    “CODE” means the Internal Revenue Code of 1986, as amended.

(f)    “COMMON STOCK” means the common stock, par value $.001 per share, of the Company.

(g)    “COMPANY” means Lexicon Pharmaceuticals, Inc., a Delaware corporation.

(h)    “CONSULTANT” means any person other than a Director or Employee who is engaged by the Company or an Affiliate to render consulting or advisory services and who is compensated for such services.

(i)    “CONTINUOUS SERVICE” means that the Participant’s service with the Company or an Affiliate, whether as an Employee, Director or Consultant, is not interrupted or terminated. The Participant’s Continuous Service shall not be deemed to have terminated merely because of a change in the capacity in which the Participant renders service to the Company or an Affiliate as an Employee, Consultant or Director or a change in the entity for which the Participant renders such service, provided that there is no interruption or termination of the Participant’s Continuous Service. For example, a change in status from a Non-Employee Director of the Company to a Consultant of an Affiliate or an Employee of the Company will not constitute an interruption





of Continuous Service. The Board or the chief executive officer of the Company, in that party’s sole discretion, may determine whether Continuous Service shall be considered interrupted in the case of any leave of absence approved by that party, including sick leave, military leave or any other personal leave.

(j)    “DIRECTOR” means a member of the Board of Directors of the Company.

(k)    “DISABILITY” means the permanent and total disability of a person within the meaning of Section 22(e)(3) of the Code.

(l)    “EMPLOYEE” means any person employed by the Company or an Affiliate. Mere service as a Director or payment of a director’s fee by the Company or an Affiliate shall not be sufficient to constitute “employment” by the Company or an Affiliate.

(m)    “EXCHANGE ACT” means the Securities Exchange Act of 1934, as amended.

(n)    “FAIR MARKET VALUE” means, as of any date, the value of the Common Stock determined as follows:

(i)    If the Common Stock is listed on any established stock exchange or traded on the Nasdaq Stock Market, the Fair Market Value of a share of Common Stock shall be the closing sales price for such stock (or the closing bid, if no sales were reported) as quoted on such exchange or market (or the exchange or market with the greatest volume of trading in the Common Stock) on the last market trading day prior to the day of determination, as reported in The Wall Street Journal or such other source as the Board deems reliable.

(ii)    In the absence of such markets for the Common Stock, the Fair Market Value shall be determined in good faith by the Board in such manner as it deems appropriate and as is consistent with the requirements of section 409A of the Code.

(o)    “INITIAL GRANT” means an Option granted to a Non-Employee Director who meets the specified criteria pursuant to subsection 6(a) of the Plan.

(p)    “NON-EMPLOYEE DIRECTOR” means a Director who is not an Employee.

(q)    “NONSTATUTORY STOCK OPTION” means an option to purchase Common Stock that is not intended to qualify as an incentive stock option within the meaning of Section 422 of the Code and the regulations promulgated thereunder.

(r)    “OPTION” means a Nonstatutory Stock Option to purchase Common Stock granted pursuant to the Plan.

(s)    “PARTICIPANT” means any Non-Employee Director to whom a Stock Award is granted pursuant to the Plan.

(t)    “PLAN” means this Lexicon Pharmaceuticals, Inc. Non-Employee Directors’ Equity Incentive Plan.

(u)    “RESTRICTED STOCK AWARD” means a right to receive restricted Common Stock granted pursuant to the Plan.

(v)    “RULE 16B-3” means Rule 16b-3 promulgated under the Exchange Act or any successor to Rule 16b-3, as in effect from time to time.

(w)    “SECURITIES ACT” means the Securities Act of 1933, as amended.

(x)    “STOCK AWARD” means any Option or Restricted Stock Award granted under the Plan.

(y)    “STOCK AWARD AGREEMENT” means a written agreement between the Company and a holder of a Stock Award evidencing the terms and conditions of an individual Stock Award grant. Each Stock Award Agreement shall be subject to the terms and conditions of the Plan.

3.    ADMINISTRATION.

(a)    ADMINISTRATION BY BOARD. The Board shall administer the Plan. The Board may not delegate administration of the Plan to a committee.






(b)    POWERS OF BOARD. The Board shall have the power, subject to, and within the limitations of, the express provisions of the Plan:

(i)    To determine the provisions of each Stock Award to the extent not specified in the Plan.

(ii)    To construe and interpret the Plan and Stock Awards granted under it, and to establish, amend and revoke rules and regulations for its administration. The Board, in the exercise of this power, may correct any defect, omission or inconsistency in the Plan or in any Stock Award Agreement, in a manner and to the extent it shall deem necessary or expedient to make the Plan fully effective.

(iii)    To amend the Plan or a Stock Award as provided in Section 13.

(iv)    Generally, to exercise such powers and to perform such acts as the Board deems necessary or expedient to promote the best interests of the Company that are not in conflict with the provisions of the Plan.

(c)    EFFECT OF BOARD’S DECISION. All determinations, interpretations and constructions made by the Board in good faith shall not be subject to review by any person and shall be final, binding and conclusive on all persons.

4.    SHARES SUBJECT TO THE PLAN.

(a)    SHARE RESERVE. Subject to the provisions of Section 12 relating to adjustments upon changes in the Common Stock, the Common Stock that may be issued pursuant to Stock Awards shall not exceed in the aggregate three hundred fifty seven thousand one hundred forty two (357,142) shares of Common Stock.

(b)    REVERSION OF SHARES TO THE SHARE RESERVE. If any Stock Award shall for any reason expire or otherwise terminate, in whole or in part, without the shares of Common Stock issuable thereunder being issued in full, the shares of Common Stock not issued under such Stock Award shall revert to and again become available for issuance under the Plan. For clarity, shares subject to an Option that are not delivered to a Participant because (i) such Participant’s right to purchase such shares are surrendered in payment of the exercise price for other shares subject to such Option in a “net exercise,” or (ii) such shares are withheld in satisfaction of the withholding of taxes incurred in connection with the exercise of such Option, the shares so surrendered or withheld shall not remain available for subsequent issuance under the Plan.

(c)    SOURCE OF SHARES. The shares of Common Stock subject to the Plan may be unissued shares or reacquired shares, bought on the market or otherwise.

5.    ELIGIBILITY.

The Stock Awards as set forth in section 6 automatically shall be granted under the Plan to all Non-Employee Directors.

6.     NON-DISCRETIONARY GRANTS.

(a)    INITIAL GRANTS. Without any further action of the Board, each person who is elected or appointed for the first time to be a Non-Employee Director automatically shall, upon the date of his or her initial election or appointment to be a Non-Employee Director, be granted an Option to purchase four thousand two hundred eighty five (4,285) shares of Common Stock on the terms and conditions set forth herein.

(b)    ANNUAL GRANTS. Without any further action of the Board, on the day following each Annual Meeting, each person who is then a Non-Employee Director, and has been a Non-Employee Director for at least six (6) months, automatically shall be granted (i) an Option to purchase two thousand eight hundred fifty seven (2,857) shares of Common Stock and (ii) a Restricted Stock Award to receive the number of shares of Common Stock determined by dividing $20,000 by the Fair Market Value of the Common Stock on the date the Restricted Stock Award is granted, rounded down to the nearest whole share number, each such Option and Restricted Stock Award to be granted on the terms and conditions set forth herein.

7.    OPTION PROVISIONS.

Each Option shall be in such form and shall contain such terms and conditions as required by the Plan. Each Option shall contain such additional terms and conditions, not inconsistent with the Plan, as the Board shall deem appropriate. Each Option





shall include (through incorporation of provisions hereof by reference in the Option or otherwise) the substance of each of the following provisions:

(a)    TERM. No Option shall be exercisable after the expiration of ten (10) years from the date it was granted.

(b)    EXERCISE PRICE. The exercise price of each Option shall be one hundred percent (100%) of the Fair Market Value of the stock subject to the Option on the date the Option is granted. Notwithstanding the foregoing, an Option may be granted with an exercise price lower than that set forth in the preceding sentence if such Option is granted pursuant to an assumption or substitution for another option in a manner satisfying the provisions of Section 424(a) of the Code.

(c)    CONSIDERATION. The purchase price of stock acquired pursuant to an Option may be paid, to the extent permitted by applicable statutes and regulations, in any combination of (i) cash or check, (ii) delivery to the Company of other Common Stock, or (iii) surrender of Participant’s right to purchase shares subject to such Option (valued, for such purposes, as the Fair Market Value of such surrendered shares on the date of exercise less the exercise price for such surrendered shares) in payment of the exercise price for other shares subject to such Option in a “net exercise” of such Option.

(d)    TRANSFERABILITY. An Option is not transferable, except (i) by will or by the laws of descent and distribution, (ii) by instrument to an inter vivos or testamentary trust, in a form accepted by the Company, in which the Option is to be passed to beneficiaries upon the death of the trustor (settlor) and (iii) by gift, in a form accepted by the Company, to a member of the “immediate family” of the Participant as that term is defined in 17 C.F.R. 240.16a-1(e). In addition, the Participant may, by delivering written notice to the Company, in a form satisfactory to the Company, designate a third party who, in the event of the death of the Participant, shall thereafter be entitled to exercise the Option.

(e)    VESTING. Options shall vest as follows:

(i)    Initial Grants of Options shall provide for vesting of 1/60th of the shares subject to the Option each month after grant for five (5) years after the date of the grant.

(ii)    Annual Grants of Options shall provide for vesting of 1/12th of the shares subject to the Option each month after grant for twelve (12) months after the date of the grant.

(f)    TERMINATION OF CONTINUOUS SERVICE. In the event an Participant’s Continuous Service terminates (other than upon the Participant’s death or Disability), the Participant may exercise his or her Option (to the extent that the Participant was entitled to exercise it as of the date of termination) but only within such period of time ending on the earlier of (i) the date six (6) months following the termination of the Participant’s Continuous Service, or (ii) the expiration of the term of the Option as set forth in the Stock Award Agreement. If, after termination, the Participant does not exercise his or her Option within the time specified in the Stock Award Agreement, the Option shall terminate.

(g)    EXTENSION OF TERMINATION DATE. If the exercise of the Option following the termination of the Participant’s Continuous Service (other than upon the Participant’s death or Disability) would be prohibited at any time solely because the issuance of shares would violate the registration requirements under the Securities Act, then the Option shall terminate on the earlier of (i) the expiration of the term of the Option set forth in subsection 7(a) or (ii) the expiration of a period of three (3) months after the termination of the Participant’s Continuous Service during which the exercise of the Option would not be in violation of such registration requirements.

(h)    DISABILITY OF PARTICIPANT. In the event an Participant’s Continuous Service terminates as a result of the Participant’s Disability, the Participant may exercise his or her Option (to the extent that the Participant was entitled to exercise it as of the date of termination), but only within such period of time ending on the earlier of (i) the date twelve (12) months following such termination or (ii) the expiration of the term of the Option as set forth in the Stock Award Agreement. If, after termination, the Participant does not exercise his or her Option within the time specified herein, the Option shall terminate.

(i)    DEATH OF PARTICIPANT. In the event (i) an Participant’s Continuous Service terminates as a result of the Participant’s death or (ii) the Participant dies within the three-month period after the termination of the Participant’s Continuous Service for a reason other than death, then the Option may be exercised (to the extent the Participant was entitled to exercise the Option as of the date of death) by the Participant’s estate, by a person who acquired the right to exercise the Option by bequest or inheritance or by a person designated to exercise the Option upon the Participant’s death, but only within the period ending on the earlier of (A) the date eighteen (18) months following the date of death or (B) the expiration of the term of such Option as set forth in the Stock Award Agreement. If, after death, the Option is not exercised within the time specified herein, the Option shall terminate.






8.     RESTRICTED STOCK AWARD PROVISIONS.

Each Restricted Stock Award shall be in such form and shall contain such terms and conditions as required by the Plan. Each Restricted Stock Award shall contain such additional terms and conditions, not inconsistent with the Plan, as the Board shall deem appropriate. Each Restricted Stock Award shall include (through incorporation of provisions hereof by reference in the Restricted Stock Award or otherwise) the substance of each of the following provisions:

(a)    CONSIDERATION. The shares of Common Stock underlying Restricted Stock Awards shall be issued to the Participant for no further consideration.

(b)    TRANSFERABILITY. A Restricted Stock Award is not transferable, except (i) by will or by the laws of descent and distribution, (ii) by instrument to an inter vivos or testamentary trust, in a form accepted by the Company, in which the Restricted Stock Award is to be passed to beneficiaries upon the death of the trustor (settlor) and (iii) by gift, in a form accepted by the Company, to a member of the “immediate family” of the Participant as that term is defined in 17 C.F.R. 240.16a-1(e).

(c)    VESTING. Unless otherwise determined by the Board, the shares of Common Stock underlying Restricted Stock Awards shall not be subject to any vesting or share repurchase option in favor of the Company.

9.    COVENANTS OF THE COMPANY.

(a)    AVAILABILITY OF SHARES. During the terms of the Stock Awards, the Company shall keep available at all times the number of shares of Common Stock required to satisfy such Stock Awards.

(b)    SECURITIES LAW COMPLIANCE. The Company shall seek to obtain from each regulatory commission or agency having jurisdiction over the Plan such authority as may be required to grant Stock Awards and to issue and sell shares of Common Stock upon exercise or grant of the Stock Awards; provided, however, that this undertaking shall not require the Company to register under the Securities Act the Plan, any Stock Award or any stock issued or issuable pursuant to any such Stock Award. If, after reasonable efforts, the Company is unable to obtain from any such regulatory commission or agency the authority which counsel for the Company deems necessary for the lawful issuance and sale of Common Stock under the Plan, the Company shall be relieved from any liability for failure to issue and sell Common Stock upon exercise or grant of such Stock Awards unless and until such authority is obtained.

10.    USE OF PROCEEDS FROM STOCK.

Proceeds from the sale of Common Stock pursuant to Options shall constitute general funds of the Company.

11.     MISCELLANEOUS.

(a)    STOCKHOLDER RIGHTS. No Participant shall be deemed to be the holder of, or to have any of the rights of a holder with respect to, any shares subject to such Stock Award unless and until such Participant has satisfied all requirements for the acquisition of shares of Common Stock underlying the Stock Award pursuant to its terms.

(b)    NO SERVICE RIGHTS. Nothing in the Plan or any instrument executed or Stock Award granted pursuant thereto shall confer upon any Participant any right to continue to serve the Company as a Non-Employee Director or shall affect the right of the Company or an Affiliate to terminate (i) the employment of an Employee with or without notice and with or without cause, (ii) the service of a Consultant pursuant to the terms of such Consultant’s agreement with the Company or an Affiliate or (iii) the service of a Director pursuant to the Bylaws of the Company or an Affiliate, and any applicable provisions of the corporate law of the state in which the Company or the Affiliate is incorporated, as the case may be.

(c)    INVESTMENT ASSURANCES. The Company may require a Participant, as a condition of exercising or acquiring Common Stock under any Stock Award, (i) to give written assurances satisfactory to the Company as to the Participant’s knowledge and experience in financial and business matters and/or to employ a purchaser representative reasonably satisfactory to the Company who is knowledgeable and experienced in financial and business matters and that he or she is capable of evaluating, alone or together with the purchaser representative, the merits and risks of the Stock Award; and (ii) to give written assurances satisfactory to the Company stating that the Participant is acquiring the Common Stock subject to the Stock Award for the Participant’s own account and not with any present intention of selling or otherwise distributing the Common Stock. The foregoing requirements, and any assurances given pursuant to such requirements, shall be inoperative if (iii) the issuance of the shares upon the exercise or acquisition of Common Stock under the Stock Award has been registered under a then currently effective registration





statement under the Securities Act or (iv) as to any particular requirement, a determination is made by counsel for the Company that such requirement need not be met in the circumstances under the then applicable securities laws. The Company may, upon advice of counsel to the Company, place legends on stock certificates issued under the Plan as such counsel deems necessary or appropriate in order to comply with applicable securities laws, including, but not limited to, legends restricting the transfer of the Common Stock.

(d)    WITHHOLDING OBLIGATIONS. The Participant may satisfy any federal, state or local tax withholding obligation relating to the exercise or acquisition of Common Stock under a Stock Award by any of the following means (in addition to the Company’s right to withhold from any compensation paid to the Participant by the Company) or by a combination of such means: (i) tendering a cash payment; (ii) authorizing the Company to withhold shares from the shares of the Common Stock otherwise issuable to the Participant as a result of the exercise or acquisition of stock under the Stock Award, provided, however, that no shares of Common Stock are withheld with a value exceeding the minimum amount of tax required to be withheld by law; or (iii) delivering to the Company owned and unencumbered shares of the Common Stock.

12.    ADJUSTMENTS UPON CHANGES IN STOCK.

(a)    CAPITALIZATION ADJUSTMENTS. If any change is made in the stock subject to the Plan, or subject to any Stock Award, without the receipt of consideration by the Company (through merger, consolidation, reorganization, recapitalization, reincorporation, stock dividend, dividend in property other than cash, stock split, liquidating dividend, combination of shares, exchange of shares, change in corporate structure or other transaction not involving the receipt of consideration by the Company), the Plan will be appropriately adjusted in the class(es) and number of securities subject to the Plan pursuant to subsection 4(a) and to be granted as nondiscretionary Options and Restricted Stock Awards specified in Section 5, and the outstanding Stock Awards will be appropriately adjusted in the class(es) and number of securities and price per share of stock subject to such outstanding Stock Awards. The Board shall make such adjustments, and its determination shall be final, binding and conclusive. For clarity, the conversion of any convertible securities of the Company shall not be treated as a transaction “without receipt of consideration” by the Company.

(b)    DISSOLUTION OR LIQUIDATION. In the event of a dissolution or liquidation of the Company, then all outstanding Stock Awards shall terminate immediately prior to such event.

(c)    ASSET SALE, MERGER, CONSOLIDATION OR REVERSE MERGER.

(i)    In the event of (i) a sale, lease or other disposition of all or substantially all of the assets of the Company, (ii) a merger or consolidation in which the Company is not the surviving corporation or (iii) a reverse merger in which the Company is the surviving corporation but the shares of Common Stock outstanding immediately preceding the merger are converted by virtue of the merger into other property, whether in the form of securities, cash or otherwise, then any surviving corporation or acquiring corporation shall assume any Stock Awards outstanding under the Plan or shall substitute similar stock awards (including an award to acquire the same consideration paid to the stockholders in the transaction described in this subsection 12(c) for those outstanding under the Plan).

(ii)    In the event any surviving corporation or acquiring corporation refuses to assume such Stock Awards or to substitute similar stock awards for those outstanding under the Plan, then the vesting of such Stock Awards shall be accelerated in full, and the Stock Awards shall terminate if not exercised (if applicable) at or prior to such event.

(iii)    In the event any surviving corporation or acquiring corporation assumes such Stock Awards or substitutes similar stock awards for those outstanding under the Plan but the Participant is not elected or appointed to the board of directors of the surviving corporation or acquiring corporation at the first meeting of such board of directors after such change in control event, then the vesting of such Stock Awards shall be accelerated by eighteen (18) months on the day after the first meeting of the board of directors of the surviving corporation or acquiring corporation.

(iv)    In the event any surviving corporation or acquiring corporation assumes such Stock Awards or substitutes similar stock awards for those outstanding under the Plan and the Participant is elected or appointed to the board of directors of the surviving corporation or acquiring corporation at the first meeting of such board of directors after such change in control event, then the vesting of such Stock Awards shall not be accelerated.

13.    AMENDMENT OF THE PLAN AND STOCK AWARDS.

(a)    AMENDMENT OF PLAN. The Board at any time, and from time to time, may amend the Plan. However, except as provided in Section 12 relating to adjustments upon changes in stock, no amendment shall be effective unless approved by the





stockholders of the Company to the extent stockholder approval is necessary to satisfy the requirements of Rule 16b-3 or any Nasdaq or other securities exchange listing requirements.

(b)    STOCKHOLDER APPROVAL. The Board may, in its sole discretion, submit any other amendment to the Plan for stockholder approval.

(c)    NO IMPAIRMENT OF RIGHTS. Rights under any Option granted before amendment of the Plan shall not be impaired by any amendment of the Plan unless (i) the Company requests the consent of the Participant and (ii) the Participant consents in writing.

(d)    AMENDMENT OF STOCK AWARDS. The Board at any time, and from time to time, may amend the terms of any one or more Stock Awards; provided, however, that the rights under any Stock Award shall not be impaired by any such amendment unless (i) the Company requests the consent of the Participant and (ii) the Participant consents in writing.

14.    TERMINATION OR SUSPENSION OF THE PLAN.

(a)    PLAN TERM. The Board may suspend or terminate the Plan at any time. Unless sooner terminated, the Plan shall terminate on the day before the tenth (10th) anniversary of the date the Plan is adopted by the Board or approved by the stockholders of the Company, whichever is earlier. No Stock Awards may be granted under the Plan while the Plan is suspended or after it is terminated.

(b)    NO IMPAIRMENT OF RIGHTS. Suspension or termination of the Plan shall not impair rights and obligations under any Stock Award granted while the Plan is in effect except with the written consent of the Participant.

15.    EFFECTIVE DATE OF PLAN.

The Plan shall become effective as determined by the Board, but no Option shall be exercised and no Restricted Stock Award shall be granted unless and until the Plan has been approved by the stockholders of the Company, which approval shall be within twelve (12) months before or after the date the Plan is adopted by the Board.

16.    CHOICE OF LAW.

All questions concerning the construction, validity and interpretation of this Plan shall be governed by the law of the State of Delaware, without regard to such state’s conflict of laws rules.






Exhibit


Exhibit 10.13

NOTICE OF STOCK OPTION GRANT

(Non-Employee Director Stock Option)

To carry out the purposes of the Lexicon Pharmaceuticals, Inc. Non-Employee Directors’ Equity Incentive Plan (the “Plan”), by providing ____________ (“Director”) the opportunity to purchase shares of Common Stock, par value $0.001 per share (“Stock”), of Lexicon Pharmaceuticals, Inc. (the “Company”) in accordance with the Plan, the Company hereby provides notice to Director as follows:

1.    Grant of Option. Effective as of ____________ (the “Grant Date”), the Company has granted Director the right and option (the “Option”) to purchase all or any part of an aggregate of [2,857 (for annual grant)] [4,285 (for initial grant)] shares of Stock, on the terms and conditions set forth in this Notice and in the Plan. The Option shall be treated as a non-statutory stock option and not as an “incentive stock option” within the meaning of section 422(b) of the Internal Revenue Code of 1986, as amended (the “Code”).

2.Exercise Price. The price at which Director may purchase Stock upon exercise of the Option (the “Exercise Price”) shall be $_______ per share, which has been determined to be the Fair Market Value (as defined in the Plan) of the Stock on the Grant Date. The Exercise Price is subject to adjustment under certain circumstances as provided in the Plan.

3.Term. The Option shall expire on the 10th anniversary of the Grant Date, subject to earlier termination under the circumstances specified in Section 8 of this Notice.

4.Exercisability and Vesting. Subject to the terms and conditions set forth in this Notice and the Plan, the Option may be exercised, in whole or in part, at any time and from time to time during the term of the Option, to purchase the number of shares of Stock that have vested and become exercisable in accordance with this Notice. The Option shall vest and become exercisable with respect to [1/12 of the total number of shares of Stock subject to the Option each month after grant for 12 months after the Grant Date (Use with annual grants)] [1/60 of the total number of shares of Stock subject to the Option each month after grant for five years after the Grant Date (Use with initial grants)]; provided that, such vesting schedule may be accelerated upon a change in control of the Company pursuant to the provisions of the Plan and; provided further, that, upon the termination of Director’s Continuous Service (as defined in the Plan), the Option shall cease to vest and shall terminate with respect to all shares of Stock that have not vested and become exercisable prior to such time.

5.Procedures for Exercise. Subject to the terms and conditions set forth in this Notice and the Plan, the Option may be exercised by delivery to the Company at its principal executive office of (i) written notice addressed to the Secretary of the Company specifying the number of shares of Stock as to which the Option is being exercised and (ii) payment in full of the Exercise Price for such shares. The Exercise Price shall be paid in cash or in such other manner as may be authorized by the administrator of the Plan in accordance with the terms of the Plan. If the offering, sale and delivery of the shares of Stock issuable upon exercise of the Option have not been registered under the Securities Act of 1933 (the “Securities Act”), the Company may require Director, as a condition to Director’s exercise of the Option, to enter into a stock purchase agreement containing such representations and warranties as the Company may deem necessary to permit the issuance of the Stock purchased upon exercise of the Option in compliance with the Securities Act and applicable state securities laws.

6.No Rights of Ownership in Stock Before Issuance. No person shall be entitled to the rights and privileges of stock ownership with respect to any shares of Stock issuable upon exercise of the Option until such shares have been issued in accordance with the terms of this Notice and the Plan.

7.Non-Transferability. The Option may not be transferred by Director otherwise than (i) by will or the laws of descent and distribution, by instrument to an inter vivos or testamentary trust or by gift to a member of Director’s immediate family, in each case in accordance with the terms of the Plan, or (ii) pursuant to a qualified domestic relations





order (as defined in Title I of the Employee Retirement Income Security Act of 1974, as amended, or the rules thereunder).

8.Termination of Option. If Director’s Continuous Service is terminated for any reason other than the Disability (as defined in the Plan) or death of Director, the Option shall remain exercisable, with respect to the shares of Stock that had vested under the terms of this Notice before the date of such termination, for a period of six months after the date of such termination (subject to extension as provided in the Plan, but in no event later than the expiration date of the Option specified in Section 3 of this Notice), following which six-month period this Notice and Director’s right to exercise the Option shall terminate. If Director’s Continuous Service is terminated because of Disability of Director, the Option shall remain exercisable, with respect to the shares of Stock that had vested under the terms of this Notice before the date of such termination, for a period of 12 months after the date of such termination (but in no event later than the expiration date of the Option specified in Section 3 of this Notice), following which 12-month period this Notice and Director’s right to exercise the Option shall terminate. If (i) Director’s Continuous Service is terminated because of death of Director or (ii) Director dies within the three-month period after the termination of Director’s Continuous Service for a reason other than death, the Option shall remain exercisable, with respect to the shares of Stock that had vested under the terms of this Notice before the date of death, for a period of 18 months after the date of such termination (but in no event later than the expiration date of the Option specified in Section 3 of this Notice), following which 18-month period this Notice and the right to exercise the Option shall terminate. Notwithstanding the foregoing, if the Director is removed from the Company’s Board of Directors for cause in accordance with the Company’s Bylaws, this Notice and Director’s right to exercise any portion of the Option, whether or not vested, shall terminate at the commencement of business on the date of such removal.

9.Withholding of Tax. To the extent that the Company is required under applicable federal or state income tax laws to withhold any amount on account of any present or future tax imposed as a result of the exercise of the Option, Director shall pay the Company, at the time of such exercise, funds in an amount sufficient to permit the Company to satisfy such withholding obligations in full. If Director fails to pay such amount, the Company shall be authorized (i) to withhold from any cash remuneration then or thereafter payable to Director any tax required to be withheld or (ii) to refuse to issue or transfer any shares otherwise required to be issued pursuant to the terms of this Notice.

10.Status of Stock. (a) Unless the offering, sale and delivery of the shares of Stock issuable upon exercise of the Option have been registered under the Securities Act, Director agrees that any shares of Stock purchased upon exercise of the Option shall be acquired for investment without a view to distribution, within the meaning of the Securities Act, and shall not be sold, transferred, assigned, pledged or hypothecated in the absence of an effective registration statement under the Securities Act and applicable state securities laws or an applicable exemption from the registration requirements of the Act and any applicable state securities laws. Director further agrees that the shares of Stock which Director may acquire by exercising the Option will not be sold or disposed of in any manner which would constitute a violation of any other applicable federal or state securities laws. In addition, Director agrees (i) that the certificates representing the shares of Stock issued under this Notice may bear such legend or legends as the administrator of the Plan deems appropriate in order to assure compliance with applicable securities laws, and (ii) that the Company may give instruction to its transfer agent, if any, to stop transfer of the shares of Stock issued under this Notice on the stock transfer records of the Company, if such proposed transfer would, in the opinion of counsel to the Company, constitute a violation of any applicable securities law or any such agreements.

(b)    Director further agrees that the Option granted herein shall be subject to the requirement that if at any time the administrator of the Plan shall determine, in its discretion, that the listing, registration or qualification of the shares of Stock subject to such Option upon any securities exchange or market or under any state or federal law, or the consent or approval of any governmental regulatory body, is necessary or desirable as a condition of, or in connection with, the purchase or issuance of shares of Stock hereunder, such Option may not be exercised in whole or in part unless such listing, registration, qualification, consent or approval shall have been effected or obtained free of any conditions not reasonably acceptable to the administrator of the Plan.

11.Non-Employee Directors’ Equity Incentive Plan. The Plan, a copy of which is available for inspection by Director or other persons entitled to exercise this Option at the Company’s principal executive office during business





hours, is incorporated by reference in this Notice. The Option is subject to, and the Company and Director agree to be bound by, all of the terms and conditions of the Plan. In the event of a conflict between this Notice and the Plan, the terms of the Plan shall control. Subject to the terms of the Plan, the administrator of the Plan shall have authority to construe the terms of this Notice, and the determinations of the administrator of the Plan shall be final and binding on Director and the Company. This Notice shall constitute a Stock Award Agreement (as defined in the Plan) evidencing the terms and conditions of the Option grant for all purposes under the Plan.




Exhibit
Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

Exhibit 10.14

COLLABORATION AND LICENSE AGREEMENT
between
LEXICON PHARMACEUTICALS, INC.
and
SANOFI
Dated as of November 5, 2015





Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

TABLE OF CONTENTS

ARTICLE 1
DEFINITIONS
1
ARTICLE 2
GRANT OF RIGHTS
24
2.1
Grants to Sanofi
24
2.2
Grants to Lexicon
24
2.3
Sublicenses
25
2.4
Disclosure of Know-How and Regulatory Documentation
25
2.5
Confirmatory Patent License
26
2.6
Exclusivity
26
2.7
LX2761 Rights
27
ARTICLE 3
DEVELOPMENT AND REGULATORY ACTIVITIES
31
3.1
Development
31
3.2
Regulatory Activities
35
ARTICLE 4
COMMERCIALIZATION
39
4.1
In General
39
4.2
Diligence
39
4.3
Commercialization Plan
39
4.4
Booking of Sales; Distribution
40
4.5
Statements and Compliance with Applicable Law
40
4.6
Subcontracting; Distributors
40
4.7
Leadership of T1DM Commercialization and Medical Affairs Activities in the (Co-)Promotion Territory
40
4.8
(Co-)Promotion Agreement
41
4.9
Product Label, Packaging and Promotional Materials
42
4.10
Commercialization Reports
42
ARTICLE 5
COLLABORATION MANAGEMENT
42
5.1
Joint Steering Committee
42
5.2
Development and Regulatory Committee
43
5.3
Manufacturing and Supply Committee
44
5.4
Joint Commercialization Committee
45
5.5
General Provisions Applicable to Committees
45
ARTICLE 6
SUPPLY
48
6.1
Supply of Licensed Products
48
6.2
Manufacturing Technology Transfer
49
6.3
Subsequent Manufacturing Technology Transfer
50
6.4
Technology Transfer Agreement
50
ARTICLE 7
PAYMENTS AND RECORDS
50
7.1
Upfront Payment
50
7.2
Milestones
50
7.3
Royalties
53
7.4
Estimated Sales Levels
57
7.5
Royalty Payments and Reports
57
7.6
Development Costs
57
7.7
Commercialization Costs and Medical Affairs Costs
59

i

Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

7.8
Calculation of T1DM Sales
61
7.9
Mode of Payment
61
7.10
Failure to Achieve Positive Results
61
7.11
Taxes
61
7.12
Interest on Late Payments
62
7.13
Financial Records
62
7.14
Audit Procedures
62
7.15
Right to Offset
63
ARTICLE 8
INTELLECTUAL PROPERTY
64
8.1
Ownership of Intellectual Property
64
8.2
Trademarks and Domain Names
65
8.3
Maintenance and Prosecution of Patents
66
8.4
Post Grant Proceedings
68
8.5
Enforcement of Patents
71
8.6
Invalidity or Unenforceability Defenses or Actions
73
8.7
Infringement Claims by Third Parties
73
8.8
Third Party Rights
74
8.9
Product Trademarks
74
ARTICLE 9
CONFIDENTIALITY AND NON-DISCLOSURE
75
9.1
Confidentiality Obligations
75
9.2
Permitted Disclosures
76
9.3
Additional Permitted Disclosures by Sanofi
77
9.4
Use of Name
77
9.5
Public Announcements
77
9.6
Publications
78
9.7
Return of Confidential Information
78
9.8
Privileged Communications
78
9.9
Form 8-K
79
ARTICLE 10
REPRESENTATIONS AND WARRANTIES
79
10.1
Mutual Representations and Warranties
79
10.2
Additional Representations and Warranties of Lexicon
80
10.3
Additional Covenants of Lexicon
84
10.4
Additional Covenants of Sanofi
85
10.5
DISCLAIMER OF WARRANTIES
86
10.6
Anti-Bribery and Anti-Corruption Compliance
87
10.7
Knowledge
87
ARTICLE 11
INDEMNITY
87
11.1
Indemnification of Lexicon
87
11.2
Indemnification of Sanofi
88
11.3
Indemnification Procedures
88
11.4
Special, Indirect and Other Lossess
90
11.5
Insurance
90
ARTICLE 12
TERM AND TERMINATION
90
12.1
HSR Filings
91
12.2
Term and Expiration
91

ii

Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

12.3
Termination
91
12.4
Rights in Bankruptcy
94
12.5
Consequences of Termination
94
12.6
Remedies
96
12.7
Accrued Rights; Surviving Obligations
96
ARTICLE 13
MISCELLANEOUS
98
13.1
Force Majeure
98
13.2
Export Control
99
13.3
Assignment and Change of Control
99
13.4
Severability
101
13.5
Dispute Resolution
101
13.6
Governing Law, Jurisdiction, Venue and Service
103
13.7
Notices
103
13.8
Entire Agreement; Amendments
105
13.9
English Language
105
13.10
Equitable Relief
105
13.11
Waiver and Non-Exclusion of Remedies
106
13.12
No Benefit to Third Parties
106
13.13
Further Assurance
106
13.14
Performance by Affiliates
106
13.15
Relationship of the Parties
106
13.16
References
107
13.17
Construction
107
13.18
Counterparts
107
13.19
Non-Solicit
107

SCHEDULES

Schedule 1.40        Corporate Names
Schedule 1.68        FTE Rates
Schedule 1.106    LX2761 Description
Schedule 1.111    LX4211 Description
Schedule 2.4        Transferred Materials
Schedule 3.1.2    Development Plan
Schedule 3.1.7    Development Reporting
Schedule 4.8.2    (Co-)Promotion Agreement Key Terms
Schedule 9.5        Press Release
Schedule 9.9        Form 8-K
Schedule 10.2.2    Existing Patents


iii

Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement (the “Agreement”) is made and entered into effective as of November 5, 2015 (the “Execution Date”) by and between Lexicon Pharmaceuticals, Inc., a Delaware corporation (“Lexicon”), and Sanofi, a société anonyme under the laws of France (“Sanofi”). Lexicon and Sanofi are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Lexicon owns and controls certain intellectual property rights with respect to the Licensed Compound (as defined herein) and Licensed Products (as defined herein) in the Territory (as defined herein); and
WHEREAS, Lexicon wishes to grant to Sanofi, and Sanofi wishes to take, an exclusive license under such intellectual property rights to develop, manufacture and commercialize Licensed Products in the Territory in the Field, in each case in accordance with the terms and conditions set forth below.
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
ARTICLE 1
DEFINITIONS

Unless otherwise specifically provided herein, the following terms shall have the following meanings:
1.1.    306 Study” means that certain study described as the 306 study in the Development Plan.
1.2.    “311 Study” means that certain study described as the 311 study in the Development Plan.
1.3.    “Accounting Standards” means, with respect to a Party or its Affiliates or its or their (sub)licensees, GAAP, International Financial Reporting Standards or such other similar national standards as such Party, Affiliate or its or their (sub)licensee uses for its financial reporting obligations, in each case, consistently applied.
1.4.    “Acquiring Party” has the meaning set forth in Section 2.6.2.
1.5.    “Adverse Event” means any untoward medical occurrence in a patient or clinical study subject administered any Licensed Products (or, in the case of a clinical study with respect to the Licensed Product, any placebo or other comparator administered in such clinical study to the extent required to be reported as an adverse event under Applicable Law), including any such occurrence (with respect to a Licensed Product, placebo or comparator, as applicable, in such circumstance) even if it does not necessarily have a causal relationship with any Licensed Product (or, in the case of any placebo or

1

Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
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comparator in any such clinical study, to the extent such occurrence is required to be reported as an adverse event under Applicable Law.
1.6.    Affiliate means, with respect to a Party or other Person, any Person that, as of any applicable time(s), directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party or other Person. For purposes of this definition, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” means: (i) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance or otherwise; or (ii) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity). Notwithstanding the foregoing, Invus, L.P., a Bermuda limited partnership, and any of its Affiliates that would not otherwise be Affiliates of Lexicon but for its and their ownership of Lexicon’s capital stock, shall not be Affiliates of Lexicon, but, for clarity, shall be Third Parties.
1.7.    “Agreement has the meaning set forth in the preamble hereto.
1.8.    “Ancillary Agreements” means the (Co-)Promotion Agreement, the Quality Agreement(s), the Technology Transfer Agreement, the Supply Agreement(s) and the SDEA.
1.9.    “Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act, as amended, the UK Bribery Act 2010, as amended and any other applicable anti-corruption laws and laws for the prevention of fraud, racketeering, money laundering or terrorism.
1.10.    Applicable Law means applicable laws, rules and regulations, including any rules, regulations, guidelines or other requirements of the Regulatory Authorities, that may be in effect from time to time, including any applicable regulations and guidances of the FDA and European Union (and national implementations thereof) that constitute good laboratory practices, good manufacturing practices, good pharmacovigilance practices and good clinical practices.
1.11.    Approval Holder” has the meaning set forth in Section 3.2.1(v).
1.12.    “Arbitration Notice” has the meaning set forth in Section 13.5.1.
1.13.    Arbitrators” has the meaning set forth in Section 13.5.2.
1.14.    “Assigned Regulatory Documentation” has the meaning set forth in Section 3.2.1(iii).
1.15.    “At-fault Party” has the meaning set forth in Section 7.6.1.
1.16.    “Benefit Data” means the Study Data from the T2DM CVOT regarding cardiovascular risk/benefit.
1.17.    “Board of Directors has the meaning set forth in the definition of “Change of Control.”
1.18.    “Breaching Party” has the meaning set forth in Section 12.3.1.

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1.19.    “Business Day” means a day other than a Saturday or Sunday or a day on which banking institutions in New York, New York or in Paris (France) are permitted or required to be closed.
1.20.    “Calendar Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date and the last Calendar Quarter shall end on the last day of the Term.
1.21.    “Calendar Year” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.
1.22.    Carry-Over Amount” has the meaning set forth in Section 7.7.1.
1.23.    Change of Control,” with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Effective Date:
1.23.1.    as a result of any transaction or series of related transactions any “person” or “group” (as such terms are defined below) (i) becomes the “beneficial owner” (as defined below, except that a “person” or “group” shall be deemed to have “beneficial ownership” of all shares of capital stock or other equity interests if such person or group has the right to acquire, whether such right is exercisable immediately or only after the passage of time), directly or indirectly, of shares of capital stock or other interests (including partnership interests) of such Party then outstanding and normally entitled (without regard to the occurrence of any contingency) to vote in the election of the directors, managers or similar supervisory positions (“Voting Stock”) of such Party representing fifty percent (50%) or more of the total voting power of all outstanding classes of Voting Stock of such Party, or (ii) acquires the power, directly or indirectly, to elect a majority of the members of the Party’s board of directors or similar governing body (“Board of Directors”);
1.23.2.    such Party enters into a merger, consolidation or similar transaction with another Person (whether or not such Party is the surviving entity) and as a result of such merger, consolidation or similar transaction (i) the members of the Board of Directors of such Party immediately prior to such transaction constitute less than a majority of the members of the Board of Directors of such Party or such surviving Person immediately following such transaction, or (ii) the Persons that beneficially owned, directly or indirectly, the shares of Voting Stock of such Party immediately prior to such transaction cease to beneficially own, directly or indirectly, shares of Voting Stock of the surviving Person representing at least a majority of the total voting power of all outstanding classes of Voting Stock of the surviving Person;
1.23.3.    such Party sells or transfers to any Third Party, in one or more related transactions, properties or assets representing all or substantially all of such Party’s consolidated total assets to which this Agreement relates; or
1.23.4.     the holders of capital stock of such Party approve a plan or proposal for the liquidation or dissolution of such Party.

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For the purpose of this definition of Change of Control: (i) “person” and “group” have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934 and the term “group” includes any group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d-5(b)(1) under the aforesaid Act; (ii) a “beneficial owner” shall be determined in accordance with Rule 13d-3 under the aforesaid Act; and (iii) the terms “beneficially owned” and “beneficially own” shall have meanings correlative to that of “beneficial owner.”
1.24.    [**] has the meaning set forth in Section 7.3.3(v).
1.25.    Combination Product” means any pharmaceutical preparation in final form containing a Licensed Compound in combination with one (1) or more additional active ingredients, sold either as a fixed dose/unit or as separate doses/units in a single package.
1.26.    Commercialization means any and all activities directed to the preparation for sale of, offering for sale of or sale of a Licensed Product, including activities related to marketing, promoting, distributing and importing such Licensed Product, and Phase 4 Studies, except Required Phase 4 Studies, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization and “Commercialized” has a corresponding meaning.
1.27.    Commercialization Costs” means, subject to Section 7.7, the FTE Costs (charged in accordance with Section 7.7) and the direct out-of-pocket costs, including all external costs for advertising and promotion (e.g., agencies, print material, congress costs (booth, symposia)), costs for post-marketing surveillance activities, costs for independent contractors engaged as permitted under this Agreement, in each case, recorded as an expense, in accordance with applicable Accounting Standards, and incurred by or on behalf of the applicable Party or any of its Affiliates after the Effective Date during the Term that are specifically identified in the Commercialization Plan or reasonably allocable to the Commercialization of a Licensed Product in accordance with this Agreement and the Commercialization Plan. For clarity, Commercialization Costs shall not include costs for general overhead, postage, communications, photocopying, printing or internet expense, professional dues, operating supplies, laboratory supplies, printers, photocopiers, fax machines or other office equipment, laboratory equipment, computers or computer service charges or any costs that were included in the calculation of or intended to be covered by the FTE Rate.
1.28.    Commercialization Plan” and “Commercialization Plans” has the meaning set forth in Section 4.3.
1.29.    Commercially Reasonable Efforts means (a) with respect to the performance of Development or Commercialization activities with respect to the Licensed Compound or a Licensed Product by Sanofi, the use of efforts and resources, not less than commercially reasonable, good faith efforts and resources, consistent with the efforts and resources generally applied by Sanofi to its owned and in-licensed compounds and products of a similar value, stage of development, life cycle, and commercial potential, taking into account all relevant factors, including issues of safety and efficacy, product profile, difficulty in developing or manufacturing the applicable Licensed Product, competitiveness of alternative Third Party products in the marketplace (including generic products), the patent or other proprietary position of the applicable Licensed Product (including patent coverage and regulatory exclusivity), the regulatory requirements involved and the potential profitability of the applicable Licensed Product and (b) with respect to the performance of Development or

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Commercialization activities with respect to the Licensed Compound or a Licensed Product by Lexicon, the use of efforts and resources, not less than commercially reasonable, good faith efforts and resources, consistent with the efforts and resources generally applied by Lexicon to its owned compounds and products of a similar value, stage of development, life cycle, and commercial potential, taking into account all relevant factors. “Commercially Reasonable” shall have a corresponding meaning.
1.30.    Competing Product” has the meaning set forth in Section 2.6.1.
1.31.    Confidential Information has the meaning set forth in Section 9.1.
1.32.    Control means, with respect to any Information and Inventions, Regulatory Documentation, material, Patent or other intellectual property right, and subject to Section 13.3.3, possession of the right, whether directly or indirectly and whether by ownership, license or otherwise (other than by operation of the license and other grants in Section 2.1 or 2.2), to grant a license, sublicense or other right (including the right to reference Regulatory Documentation) to or under such Information and Inventions, Regulatory Documentation, material, Patent or other intellectual property right as provided for herein without violating the terms of any agreement with any Third Party.
1.33.    (Co-)Promote” or “(Co-)Promotion” means the Detailing of the (Co-)Promotion Product(s) for T1DM and T2DM by Lexicon or its Affiliates under the relevant Regulatory Approval and the Product Trademarks.
1.34.    (Co-)Promotion Agreement” has the meaning set forth in Section 4.8.2.
1.35.    (Co-)Promotion Product(s)” has the meaning set forth in Section 4.8.1.
1.36.    (Co-)Promotion Right” has the meaning set forth in Section 4.8.1.
1.37.    (Co-)Promotion Term” means that period commencing on the effective date of the (Co-)Promotion Agreement and ending on the first date on which Lexicon’s (Co-)Promotion Right with respect to the (Co-)Promotion Product(s) terminate pursuant to this Agreement or the (Co-)Promotion Agreement.
1.38.    (Co-)Promotion Territory” means the United States.
1.39.    Core Development Plan” means those activities under the Development Plan sufficient for [**] in the United States and [**] in the European Union [**].
1.40.    Corporate Names” means the Trademarks and logos identified on Schedule 1.40 and such other names and logos as Lexicon may designate in writing from time to time.
1.41.    Cost Sharing Trigger Point” has the meaning set forth in Section 7.6.1(i).
1.42.    Cover” means, with respect to a Patent and a compound, product, invention or other technology, that the making, using, selling, offering for sale or importing of such compound, product, invention or other technology would, but for ownership or a license to such Patent, infringe such Patent (or, in the case such Patent is a patent application, a patent that issues on such patent application). “Covered” has a corresponding meaning.
1.43.    Decision Point” has the meaning set forth in Section 3.1.3.

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1.44.    Detail” means, with respect to a (Co-)Promotion Product in the (Co-)Promotion Territory, a sales presentation or interaction by a professional sales representative to or with a target physician or other medical professional with prescribing authority involved in prescribing a (Co-)Promotion Product or to other individuals influencing prescription activity with respect to a (Co-)Promotion Product, in any case, in which the primary purpose is to discuss the benefits and features of the (Co-)Promotion Product. The term Detail may be further defined in the (Co-)Promotion Agreement. When used as a verb, “Detail” or “Detailing” means to perform a Detail.
1.45.    Development” means all activities related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, clinical studies, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval (including any Required Phase 4 Studies). When used as a verb, “Develop” means to engage in Development.
1.46.    Development and Regulatory Committee” or “DRC” has the meaning set forth in Section 5.2.
1.47.    Development Costs” means, subject to Section 7.6, the FTE Costs (charged in accordance with Section 7.6.1) and the direct out-of-pocket costs recorded as an expense, in accordance with applicable Accounting Standards, in each case, incurred by or on behalf of the applicable Party or any of its Affiliates after the Effective Date during the Term that are specifically identified in the Development Plan or reasonably allocable to the Development of a Licensed Product in accordance with this Agreement and the Development Plan. For clarity, Development Costs shall not include costs for general overhead, postage, communications, photocopying, printing or internet expense, professional dues, operating supplies, laboratory supplies, printers, photocopiers, fax machines or other office equipment, laboratory equipment, computers or computer service charges or any costs that were included in the calculation of or intended to be covered by the FTE Rate. For clarity, Development Costs for clinical quantities of Licensed Product and placebo or comparator supplied hereunder or under any Supply Agreement shall be based on the Manufacturing Costs therefor as set forth in Section 6.1 and, if applicable, shared in accordance with Section 7.6.
1.48.    Development Plan” has the meaning set forth in Section 3.1.2(i).
1.49.    Dispute has the meaning set forth in Section 13.5.1.
1.50.    Distributor” means any Third Party appointed by Sanofi or any of its Affiliates or its or their Sublicensees to distribute, market and sell Licensed Product(s), with or without packaging rights, in one or more countries in the Territory, in circumstances where (i) the Third Party purchases its requirements of Licensed Product(s) from Sanofi or its Affiliates or its or their Sublicensees but does not otherwise make any upfront, royalty or other payment (separate from a payment for supply of Licensed Product) to Sanofi or its Affiliates or its or their Sublicensees with respect to Licensed Product(s) and (ii) the Third Party does not engage in any material promotional activity with respect to Licensed Product(s).
1.51.    Dollars” or “$” means United States Dollars.

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1.52.    Domain Names” has the meaning set forth in Section 8.2.3.
1.53.    Drug Approval Application” means a New Drug Application or Supplemental New Drug Application as defined in the FFDCA or any corresponding foreign application in the Territory, including, with respect to the European Union, a Marketing Authorization Application filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval.
1.54.    Effective Date has the meaning set forth in Section 12.1.
1.55.    EMA means the European Medicines Agency and any successor agency thereto.
1.56.    European Union” means the economic, scientific and political organization of member states as it may be constituted from time to time, which as of the Execution Date consists of Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom of Great Britain and Northern Ireland and that certain portion of Cyprus included in such organization.
1.57.    Execution Date” has the meaning set forth in the preamble hereto.
1.58.    Existing Clinical Trial Applications” means those clinical trial applications listed on Schedule 1.58.
1.59.    Existing Patents” has the meaning set forth in Section 10.2.2.
1.60.    Existing Regulatory Documentation” means the Regulatory Documentation Controlled by Lexicon or any of its Affiliates as of the Effective Date, including that certain IND number 102191 and the Existing Clinical Trial Applications.
1.61.    Exploit” means to make, have made, import, use, sell or offer for sale, including to research, Develop, Commercialize, register, Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market or have sold or otherwise dispose of a compound, product or process, including to make Licensed Compound for use in Licensed Products. “Exploitation means the act of Exploiting a compound, product or process.
1.62.    FDA means the United States Food and Drug Administration and any successor agency thereto.
1.63.    FFDCA means the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).
1.64.    Field” means any and all uses in humans or animals, including therapeutic, diagnostic and prophylactic uses.
1.65.    First Commercial Sale” means, with respect to a Licensed Product or the (Co-)Promotion Product, as applicable, and a country, the first sale for monetary value for use or consumption by the end user of such Licensed Product or the (Co-)Promotion Product, as applicable, in such country

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after Regulatory Approval for such Licensed Product or the (Co-)Promotion Product, as applicable, has been obtained in such country. Sales prior to receipt of Regulatory Approval for such Licensed Product or the (Co-)Promotion Product, as applicable, such as so-called “treatment IND sales,” “named patient sales,” and “compassionate use sales,” shall not be construed as a First Commercial Sale.
1.66.    FTE” means the equivalent of the work of one (1) employee full time for one (1) Calendar Year (consisting of at least a total of [**] hours per Calendar Year) of work directly related to the applicable Development activities with respect to a Licensed Product or the applicable Commercialization activities or Medical Affairs Activities with respect to a Licensed Product, as applicable. No additional payment shall be made with respect to any person who works more than [**] hours per Calendar Year and any person who devotes less than [**] hours per Calendar Year (or such other number as may be agreed by the JSC) shall be treated as an FTE on a pro rata basis based upon the actual number of hours worked divided by [**]. For purposes of the T1DM Commercialization Plan for the United States (and thus determination of Commercialization Costs and Medical Affairs Costs subject to sharing by the Parties), FTEs shall include only such personnel as are specifically devoted to (i) sales and sales management devoted to Specialist Efforts that are directed, principally or at least in substantial part, to T1DM, (ii) marketing, market analytics or market access for T1DM or (iii) Medical Affairs Activities for T1DM, and in each case ((i), (ii) and (iii)) not for other personnel or functions involved in Commercialization or Medical Affairs Activities more generally.
1.67.    FTE Costs” means, for any period, the applicable FTE Rate multiplied by the applicable number of FTEs of the Party performing Development activities during such period in accordance with the Development Plan or Commercialization activities or Medical Affairs Activities during such period in accordance with the Commercialization Plan. Schedule 1.68 or the (Co-)Promotion Agreement shall set forth the costs and expenses which are included in each FTE Rate.
1.68.    FTE Rate” means, as of the Effective Date, for the applicable category of activity, the rate as set forth in Schedule 1.68; provided that such rates shall be adjusted annually, with each annual adjustment effective as of January 1 of each Calendar Year, with the first such annual adjustment to be made as of [**], to correspond with the total percentage change in the Producer Price Index (PPI) for Pharmaceutical and Medicine Manufacturing (NAICS 325400) for the twelve (12)-month period preceding each such January 1; provided further, the (Co-)Promotion Agreement shall set forth the initial FTE Rates for any other category of Commercialization activities or Medical Affairs Activities not described in Schedule 1.68, which FTE Rates shall be adjusted pursuant to the preceding proviso in this Section 1.68.
1.69.    Fundamental Event” means [**]; provided, however, that none of the following shall constitute, or shall be considered in determining whether there has occurred, a Fundamental Event: (i) any change arising out of or resulting from actions contemplated by the Parties in connection with this Agreement; (ii) any action taken pursuant to or in accordance with this Agreement or at the request of or with the consent of Sanofi; (iii) any fees or expenses anticipated as of the Execution Date to be incurred in connection with the transactions contemplated by this Agreement; or (iv) any change of circumstances with respect to any product or product candidate of Sanofi other than the Licensed Product.
1.70.    GAAP means United States generally accepted accounting principles.
1.71.    Generic Product means, with respect to a Licensed Product, any pharmaceutical or biological product that (i) is distributed by a Person other than Sanofi or its Affiliates under a Drug

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Approval Application approved by a Regulatory Authority in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Licensed Product, including any product authorized for sale (a) in the U.S. pursuant to Section 505(b)(2) or Section 505(j) of the FFDCA (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively), (b) in the European Union pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision) or (c) in any other country or jurisdiction pursuant to all equivalents of such provisions or (ii) is otherwise substitutable under Applicable Law for such Licensed Product when dispensed without the intervention of a physician or other health care provider with prescribing authority.
1.72.    Generic Version” means, with respect to a Competing Product, any pharmaceutical or biological product that (i) is distributed by a Person under a Drug Approval Application approved by a Regulatory Authority in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Competing Product, including any product authorized for sale (a) in the U.S. pursuant to Section 505(b)(2) or Section 505(j) of the FFDCA (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively), (b) in the European Union pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision) or (c) in any other country or jurisdiction pursuant to all equivalents of such provisions or (ii) is otherwise substitutable under Applicable Law for such Competing Product when dispensed without the intervention of a physician or other health care provider with prescribing authority.
1.73.    Government Official” means (i) any Person employed by or acting on behalf of a government, government-controlled agency or entity or public international organization, (ii) any political party, party official or candidate, (iii) any Person who holds or performs the duties of an appointment, office or position created by custom or convention or (iv) any Person who holds himself out to be the authorized intermediary of any of the foregoing.
1.74.    Hatch-Waxman Act” means the U.S. “Drug Price Competition and Patent Term Restoration Act” of 1984, as set forth at 21 U.S.C. §355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV).
1.75.    HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (15 U.S.C. §18a) and the rules and regulations promulgated thereunder.
1.76.    HSR Filing” has the meaning set forth in Section 12.1.
1.77.    “IFRS” shall mean International Financial Reporting Standards as issued by the International Accounting Standards Board (IASB) and as adopted by the European Union.
1.78.    IND” means (i) an investigational new drug application filed with the FDA for authorization to commence clinical studies or its equivalent in other countries or regulatory jurisdictions and (ii) all supplements and amendments that may be filed with respect to the foregoing, together with all non-United States equivalents for (i) or (ii) (in each case ((i) and (ii)), including any clinical trial applications filed with the EMA or other jurisdictions.
1.79.    Indemnification Claim Notice has the meaning set forth in Section 11.3.1.

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1.80.    Indemnified Party has the meaning set forth in Section 11.3.1.
1.81.    Information and Inventions” means all inventions, discoveries, technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including: biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, assays and biological methodology, in each case (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed.
1.82.    Infringement has the meaning set forth in Section 8.5.1.
1.83.    Initial Data” means the analysis of the T2DM CVOT Study Data for the first filing for Regulatory Approval in the United States.
1.84.    In-License Agreements” has the meaning set forth in Section 10.2.4.
1.85.    Inventor Personnel” means officers, employees, agents and consultants of a Party or any of its Affiliates who are inventors of or have otherwise contributed in a material manner to the creation or development of any Lexicon Patent, Lexicon Know-How, Sanofi Patent, Sanofi Know-How, Joint Patent, Joint Know-How or who are or will be performing Development activities hereunder or who otherwise have access to any Confidential Information or Information and Inventions of either Party.
1.86.    Invoiced Sales has the meaning set forth in the definition of “Net Sales.”
1.87.    Japan Decision Date” has the meaning set forth in Section 12.3.3.
1.88.    Joint Commercialization Committee” or “JCC” has the meaning set forth in Section 5.4.
1.89.    Joint Intellectual Property Rights has the meaning set forth in Section 8.1.2.
1.90.    Joint Know-How has the meaning set forth in Section 8.1.2.
1.91.    Joint Patents has the meaning set forth in Section 8.1.2.
1.92.    Joint Steering Committee or JSC” has the meaning set forth in Section 5.1.
1.93.    JSC Dispute” has the meaning set forth in Section 13.5.1.
1.94.    Know-How Transfer Plan” has the meaning set forth in Section 2.4.4.
1.95.    Legal Dispute” has the meaning set forth in Section 5.5.4.
1.96.    Lexicon” has the meaning set forth in the preamble hereto.

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1.97.    Lexicon CMOs” means contract manufacturing organizations, including [**], currently subcontracting manufacturing activities related to any Licensed Compound or Licensed Product in the name and on behalf of Lexicon.
1.98.    Lexicon CROs” means contract research organizations, including [**], currently subcontracting clinical development activities related to any Licensed Compound or Licensed Product in the name and on behalf of Lexicon.
1.99.    Lexicon Consent Right” means, with respect to a decision or dispute as to the following matters, Lexicon or its JSC representatives have a right of consent: (i) if Lexicon exercises the (Co-)Promotion Right, the adoption of or any amendment to the T1DM Commercialization Plan, (ii) any amendment of the Development Plan that would [**], (iii) an amendment to the Development Plan that would [**], (iv) any material amendment to the Development Plan other than to the extent such amendment is [**], (v) any amendment of the Development Plan with respect to the Development of Licensed Products for T1DM (including any modification of the activities to be performed by Lexicon), including any agreement with a Regulatory Authority to undertake Required Phase 4 Studies in connection with obtaining a Regulatory Approval of a Licensed Product for T1DM, or (vi) any matter that expressly requires consent of Lexicon hereunder.
1.100.    Lexicon Know-How” means, subject to Section 13.3.3, all Information and Inventions that are Controlled by Lexicon or any of its Affiliates as of the Execution Date or at any time prior to the end of the Term and that are either (i) (a) generated in the course of the research or Development of Licensed Compound(s) or Licensed Product(s), and (b) related to any Licensed Compounds or Licensed Product or the Exploitation of any of the foregoing and that are useful for such Exploitation, or (ii) otherwise generated or acquired and necessary for or used by or on behalf of Lexicon to manufacture, or incorporated by or on behalf of Lexicon into, the LX4211 Product; provided that Lexicon Know-How excludes Joint Know-How.
1.101.    Lexicon Maximum Amount” means, for a given Calendar Year, the amount equal to [**].
1.102.    Lexicon Patents” means, subject to Section 13.3.3, all of the Patents Controlled by Lexicon or any of its Affiliates as of the Execution Date or at any time prior to the end of the Term that Cover any Licensed Compounds or Licensed Products or the Exploitation of any of the foregoing and that are useful for such Exploitation; provided that Lexicon Patents exclude Joint Patents. The Lexicon Patents include the Existing Patents.
1.103.    Licensed Compound means (i) LX4211, (ii) any other compounds (other than LX2761) Covered by the Existing Patents, and (iii) any metabolite, salt, ester, hydrate, solvate, isomer, enantiomer, free acid form, free base form, crystalline form, co-crystalline form, amorphous form, pro-drug (including ester pro-drug) form, racemate, polymorph, chelate, stereoisomer, tautomer or optically active form of any of the foregoing, in each case of clauses (i) through (iii), that are, as of the Execution Date, or thereafter become Controlled by Lexicon or, subject to Section 13.3.3, any of its Affiliates.
1.104.    Licensed Product means any pharmaceutical preparation in final form that is comprised of or contains a Licensed Compound, alone or in combination with one (1) or more additional active ingredients in any and all forms, presentations, delivery systems, dosages and formulations, for sale by prescription, over-the-counter or any other method.

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Asterisks denote omissions.

1.105.    Losses” has the meaning set forth in Section 11.1.
1.106.    LX2761” means the pharmaceutical compound known as LX2761 described in Schedule 1.106.
1.107.    LX2761 Development Costs” means FTE Costs and the direct out-of-pocket costs, in each case recorded as an expense, in accordance with applicable Accounting Standards, and incurred by or on behalf of Lexicon or any of its Affiliates that are reasonably allocable to the Development of LX2761. For clarity, LX2761 Development Costs shall not include costs for general overhead, postage, communications, photocopying, printing or internet expense, professional dues, operating supplies, laboratory supplies, printers, photocopiers, fax machines or other office equipment, laboratory equipment, computers or computer service charges. For clarity, LX2761 Development Costs include manufacturing costs for clinical quantities of LX2761 and placebo calculated consistent with the definition of “Manufacturing Cost” as if LX2761 were a Licensed Compound.
1.108.    LX2761 Phase 3 T2DM Study” means a pivotal human clinical trial, the results of which could be used to establish safety and efficacy of a product comprised of or containing LX2761 in T2DM as a basis for a Drug Approval Application in accordance with or otherwise in satisfaction of the requirements of 21 CFR 312.21(c) or analogous requirements of the European Union.
1.109.    LX2761 POC Study” means a human clinical trial that is intended to initially evaluate the dosing and effectiveness of LX2761 for T1DM or T2DM in patients with T1DM or T2DM, as applicable, in accordance with or otherwise in satisfaction of the requirements of 21 CFR 312.21(b) or analogous requirements of the European Union.
1.110.    LX2761 Study Data” has the meaning set forth in Section 2.7.2(ii).
1.111.    LX4211” means the pharmaceutical compound known as LX4211 described in Schedule 1.111.
1.112.    LX4211 Product” means a Licensed Product that includes LX4211.
1.113    Major Market” means, subject to Section 12.3.3, each of the United States, France, Germany, Italy, the United Kingdom and Spain.
1.114.    Major Pharmaceutical Company” means a pharmaceutical company that, together with its Affiliates, on a worldwide basis, was one of the [**] largest global pharmaceutical companies, as measured by [**], during the most recently ended Calendar Year as of the relevant time.
1.115.    Manufacture” and “Manufacturing” means all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and holding of any Licensed Compound, any Licensed Product or any intermediate thereof, including process development, process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control, and chemistry, manufacturing and controls.
1.116.    Manufacturing and Supply Committee” or “MSC” has the meaning set forth in Section 5.3.

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1.117.    Manufacturing Cost” means, with respect to any Licensed Product, Licensed Compound, placebo or comparator Manufactured directly by a Party, its Affiliates or its or their Sublicensees hereunder, the standard unit cost of Manufacture of such Licensed Product, Licensed Compound, placebo or comparator consisting of direct material and added value attributable to such Licensed Product, Licensed Compound, placebo or comparator all calculated in accordance with internal cost accounting policy and procedures, consistently applied. Standard unit cost may be adjusted on an exceptional basis for any significant attributable variances as agreed by the Parties. Direct material costs will consist of the costs incurred in Manufacturing or purchasing materials for use in Manufacturing such Licensed Product, Licensed Compound, placebo or comparator including Third Party purchase price, taxes, transportation costs, freight, customs duty and charges levied by governmental authorities and all costs of packaging components. Added value will consist of (i) direct labor costs representing the costs of employees engaged in direct Manufacturing activities, (ii) direct labor costs representing the costs of employees engaged in direct or indirect quality control and quality assurance activities which are involved in the Manufacturing and packaging of such Licensed Product, Licensed Compound, placebo or comparator and (iii) such manufacturing site’s (sites’) overhead and depreciation that are attributable to the Manufacturing and packaging such Licensed Product, Licensed Compound, placebo or comparator based on calculations and allocations consistent with the industrial cost accounting method used by such Party (provided that such overhead and depreciation shall exclude any costs that such Party does not customarily include in the determination of cost of goods sold under its Accounting Standards). For clarity, overhead will not include any corporate or non-manufacturing site specific administrative overhead costs, plant start-up costs or costs associated with excess or idle capacity. Such Manufacturing Costs are updated periodically according to the policy of such Party and promptly notified to the other Party. Alternatively, if such Licensed Product, Licensed Compound, placebo or comparator is Manufactured by a Third Party manufacturer, the Manufacturing Cost means the actual price paid by such Party or its Affiliates to the Third Party for the Manufacture, supply and packaging of such Licensed Product, Licensed Compound, placebo or comparator transportation costs, freight, customs duty and charges levied by governmental authorities, all taxes and shipping costs related thereto, depreciation (on any equipment used in such Manufacture that is owned by the Party or any of its Affiliates and allocated as described above, depreciation shall be included to the extent provided and calculated as above), the cost of any materials supplied and paid for by such Party, reasonable and necessary costs (including salaries and benefits, supplies and equipment and other disposable goods to the extent required for the performance of the applicable activities) of such Party’s or its Affiliates’ employees engaged in activities relating to the selection and management of such Third Party manufacturer and the management of such supply (including quality control, quality assurance, procurement and supply chain activities) and the enforcement of agreements with Third Party manufacturers. Manufacturing Costs include any amounts paid to a Third Party supplier for intellectual property rights relating to Licensed Product or Licensed Compound supplied by such supplier, whether through a higher transfer price or separate payment of milestones, royalties or other financial consideration.
1.118.    [**] has the meaning set forth in Section 7.3.3(v).
1.119.    Manufacturing Process” has the meaning set forth in Section 6.2.
1.120.    Material Breach Notice” has the meaning set forth in Section 12.3.1.
1.121.    Medical Affairs Activities” means the coordination of medical information requests and field based medical scientific liaisons with respect to the Licensed Product, including

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activities of medical scientific liaisons and the provision of medical information services with respect to the Licensed Product.
1.122.    Medical Affairs Costs” means, subject to Section 7.7, the FTE Costs (charged in accordance with Section 7.7) and the direct out-of-pocket costs, including costs for independent contractors engaged as permitted under this Agreement, in each case, recorded as an expense, in accordance with applicable Accounting Standards, and incurred by or on behalf of the applicable Party or any of its Affiliates after the Effective Date during the Term that are specifically identified in the Commercialization Plan or reasonably allocable to the Medical Affairs Activities in accordance with this Agreement and the Commercialization Plan. For clarity, Medical Affairs Costs shall not include costs for general overhead, postage, communications, photocopying, printing or internet expense, professional dues, operating supplies, laboratory supplies, printers, photocopiers, fax machines or other office equipment, laboratory equipment, computers or computer service charges or any costs that were included in the calculation of or intended to be covered by the FTE Rate.
1.123.    Net Sales” means, with respect to a Licensed Product for any period, the gross amount billed or invoiced by Sanofi, its Affiliates or its or their Sublicensees for the sale of such Licensed Product in the Territory during the Royalty Term for the applicable Licensed Product in the applicable country to Third Parties (including Distributors, but excluding distributors other than Distributors (which non-Distributor distributors shall, for purposes of this definition, be deemed to be Sublicensees)) (the “Invoiced Sales”), less deductions for:
1.123.1. normal and customary trade, quantity and prompt settlement discounts (including chargebacks and allowances) actually allowed, incurred or accrued;
1.123.2. amounts repaid or credited by reason of rejection, return or recall of goods, rebates or bona fide price reductions;
1.123.3. freight, postage, shipping and insurance expenses to the extent that such items are included in the gross amount invoiced;
1.123.4. customs and excise duties and other taxes or duties related to the sales to the extent that such items are included in the gross amount invoiced;
1.123.5. rebates and similar payments made with respect to sales paid to any governmental or regulatory authority such as, by way of illustration and not in limitation of the Parties’ rights hereunder, Federal or state Medicaid, Medicare or similar state program or equivalent foreign governmental program;
1.123.6. the portion of normal and customary administrative fees paid during the relevant time period to group purchasing organizations or pharmaceutical benefit managers relating to such Licensed Product; and
1.123.7. any invoiced amounts that are not collected by Sanofi, its Affiliates or its or their Sublicensees, including bad debts; and
1.123.8. that portion of the [**] that Sanofi, its Affiliate or its or their Sublicensee, as applicable, allocates to sales of the Licensed Products in accordance with Sanofi’s, its Affiliate’s or its

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or their Sublicensee’s standard policies and procedures consistently applied across its products, as applicable, and [**];
Any of the deductions listed above that involves a payment by Sanofi, its Affiliates or its or their Sublicensees shall be taken as a deduction in the Calendar Quarter in which the payment is accrued by such entity. For purposes of determining Net Sales, a Licensed Product shall be deemed to be sold when invoiced and a “sale” shall not include transfers or dispositions of such Licensed Product for pre-clinical or clinical purposes or as samples, in each case, without charge. Sanofi’s, its Affiliates’ or its or their Sublicensees’ transfer of any Licensed Product to an Affiliate or Sublicensee shall not result in any Net Sales, unless such Licensed Product is consumed by such Affiliate or Sublicensee in the course of its commercial activities.
(a) In the event that a Licensed Product is sold in any country in the form of a Combination Product, and there is a valid and unexpired Patent in such country that Covers the active ingredient(s) in such Combination Product other than the Licensed Compound(s) included in the Combination Product and such active ingredient(s) have not become available as a generic product(s) in such country, Net Sales of such Combination Product shall be adjusted by multiplying actual Net Sales of such Combination Product in such country calculated pursuant to the foregoing definition of “Net Sales” by the fraction A/(A+B), where A is the average invoice price in such country of any Licensed Product that contains the same Licensed Compound(s) as such Combination Product as its sole active ingredient(s), if sold separately in such country, and B is the average invoice price in such country of each product that contains active ingredient(s) other than the Licensed Compound(s) contained in such Combination Product as its sole active ingredient(s) if sold separately in such country; provided that the invoice price in a country for each Licensed Product that contains only the Licensed Compound(s) and each product that contains solely active ingredient(s) other than the Licensed Compound(s) included in the Combination Product shall be for a dosage quantity comparable to that used in such Combination Product and of substantially the same class, purity and potency or functionality, as applicable.
(b) In the event that a Licensed Product is sold in any country in the form of a Combination Product, and either there is no valid and unexpired Patent in such country that Covers the active ingredient(s) in such Combination Product other than the Licensed Compound(s) included in the Combination Product or all such active ingredient(s) have become available as a generic product(s) in such country, Net Sales of such Combination Product shall be adjusted by multiplying actual Net Sales of such Combination Product in such country calculated pursuant to the foregoing definition of “Net Sales” by the fraction X/Y, where X is the average invoice price in such country of any Licensed Product that contains the same Licensed Compound(s) as such Combination Product as its sole active ingredient(s), if sold separately in such country in significant quantities, and Y is the average invoice price in such country of such Combination Product; provided that the invoice price in a country for each Licensed Product that contains only the Licensed Compound(s) shall be for a dosage quantity comparable to that used in such Combination Product and of substantially the same class, purity and potency or functionality, as applicable; provided, further that if such Licensed Product is not sold in significant quantities in such country, then Net Sales of such Combination Product shall be calculated in accordance with the immediately following paragraph.
In the case of paragraphs (a) above, if either such Licensed Product that contains the Licensed Compound(s) as its sole active ingredient or a product that contains the active ingredient(s) (other than the Licensed Product) in the Combination Product as its sole active ingredient(s) is not sold separately in a particular country, or in the case of paragraph (b) above, if such Licensed Product having the Licensed Compound(s) as its sole active ingredient is not sold separately in the particular country in significant quantities, such

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that the applicable invoice price(s) needed for the calculations in such paragraphs are not available or representative, the Parties shall negotiate in good faith a reasonable adjustment to Net Sales in such country that takes into account the commercial value contribution to the Combination Product of and all other factors reasonably relevant to the relative commercial value of, the Licensed Compound(s), on the one hand and all of the other active ingredient(s), collectively, on the other hand. If the Parties are unable to reach agreement on any such adjustment, such matter shall be resolved through binding arbitration in accordance with Section 13.5.
In the case of pharmacy incentive programs, hospital performance incentive programs, chargebacks, disease management programs, similar programs or discounts on portfolio product offerings, all rebates, discounts and other forms of reimbursements shall be allocated among products on the basis on which such rebates, discounts and other forms of reimbursements were actually granted or, if such basis cannot be determined, in accordance with Sanofi’s, its Affiliates’ or its or their Sublicensees’ existing allocation method consistently applied across their products, as applicable; provided that any such allocation shall be done in accordance with Applicable Law, including any price reporting laws, rules and regulations.
Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of Sanofi, its Affiliates or its or their Sublicensees, which must be in accordance with applicable Accounting Standards.
1.124.     Non-Breaching Party” has the meaning set forth in Section 12.3.1.
1.125.    Non-Competitive Acquirer” means a Third Party Acquirer that is not a Sanofi Competitor and does not have any Affiliates that are Sanofi Competitors.
1.126.    Notice Period” has the meaning set forth in Section 12.3.1.
1.127.    Opt-In” means the withdrawal under Article 83(4) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01) of the Opt-Out of a Patent.
1.128.    Opt-Out” means the opt-out of a Patent from the exclusive competence of the Unified Patent Court under Article 83(3) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01).
1.129.    Party and Parties have the meaning set forth in the preamble hereto.
1.130.    Patents” means: (i) all national, regional and international patents and patent applications, including provisional patent applications; (ii) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications; (iii) any and all patents that have issued or in the future issue from the foregoing patent applications ((i) and (ii)), including utility models, petty patents, innovation patents and design patents and certificates of invention; (iv) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((i), (ii) and (iii)); and (v) any similar rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents.

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1.131.    Payment has the meaning set forth in Section 7.11.1.
1.132.    Person means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.
1.133.    Phase 4 Study” means a study or data collection effort with respect to any Licensed Product that are performed after the receipt of Regulatory Approval in the country where such trial is conducted, regardless of when such study or data collection effort has commenced.
1.134.    PoC Successful Completion” means achievement of the primary endpoint in any LX2761 PoC Study based on top line data [**].
1.135.    Positive Results” has the meaning set forth in Section 3.1.3.
1.136.    Positive Results Failure” has the meaning set forth in Section 12.3.2(i).
1.137.    Post Grant Proceeding” means any proceedings before any national Patent authority involving the review, examination, analysis or any combination thereof, of any issued Patent. Examples of Post Grant Proceedings include post grant review proceedings, inter partes review proceedings, supplemental examination, patent interference proceedings, opposition proceedings initiated on and after issuance of the applicable Patent, reissue and reexamination.
1.138.    Pre-Generic Launch Net Sales” has the meaning set forth in Section 7.3.3(i).
1.139.    Product Trademarks” means the Trademark(s) used or to be used by Sanofi or its Affiliates or its or their Sublicensees for the Commercialization of any Licensed Product in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding, in any event, any trademarks, service marks, names or logos that include any corporate name or logo of the Parties or their Affiliates or its or their Sublicensees).
1.140.    P3 Successful Completion” means the completion of the first two (2) LX2761 Phase 3 T2DM Studies, in each case, in which the primary endpoint is achieved based on top line data [**].
1.141.    Quality Agreement(s)” means the quality agreement(s) entered into between the Parties or their Affiliates relating to (i) the conduct of clinical studies of Licensed Products pursuant to Section 3.1.2(v) or (ii) the supply of Licensed Products pursuant to Section 6.1.
1.142.    Regulatory Approval” means, with respect to a country in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations or authorizations of any Regulatory Authority necessary to commercially distribute, sell or market a Licensed Product in such country, including, where applicable, (i) [**], (ii) pre- and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto) and (iii) labeling approval.
1.143.    Regulatory Authority” means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or

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other government entities regulating or otherwise exercising authority with respect to the Exploitation of Licensed Compound or Licensed Products in the Territory, including the FDA in the United States and the EMA in the European Union.
1.144.    Regulatory Documentation” means all (i) applications (including all INDs and Drug Approval Applications), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (ii) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all Adverse Event files and complaint files; and (iii) clinical and other data, including Study Data, agreements and correspondence with investigators, Lexicon CROs or Lexicon CMOs, contained or relied upon in any of the foregoing; in each case ((i), (ii) and (iii)) relating to the Licensed Compound or a Licensed Product.
1.145.    Regulatory Exclusivity Period” means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that confers exclusive marketing rights with respect to such Licensed Product in such country or that confers data exclusivity or similar exclusivity such that Third Parties or the applicable Regulatory Authority(-ies) in such country are restricted from relying on data used to obtain Regulatory Approval for the Licensed Product in applying for or granting Regulatory Approval to Third Party products.
1.146.    Required Phase 4 Studies” means any Phase 4 Studies that are required by the applicable Regulatory Authority to be performed after Regulatory Approval as a condition for Regulatory Approval, regardless of when commenced.
1.147.    Restricted Rights” has the meaning set forth in Section 2.6.2.
1.148.    Retained Regulatory Documentation” has the meaning set forth in Section 3.2.1(ii).
1.149.    Reversion Products” means any LX4211 Product and any other Licensed Product for which pre-clinical animal studies or human clinical Development or Commercialization has been conducted prior to the applicable termination of this Agreement.
1.150.    ROFN1 Development Costs” has the meaning set forth in Section 2.7.2(ii).
1.151.    ROFN2 Development Costs” has the meaning set forth in Section 2.7.3(ii).
1.152.    ROW” or “Rest of World” has the meaning set forth in Section 7.3.1(iv).
1.153.    Royalty Term” means, with respect to each Licensed Product and each country in the Territory, the period beginning on the Effective Date and ending on the latest to occur of: (i) the expiration of the last-to-expire issued (A) Sanofi Patent that meets the criteria set forth in clause (i) of Section 1.158, (B) Lexicon Patent or (C) Joint Patent in such country, in each case ((A), (B) and (C)), that contains a Valid Claim that Covers the applicable Licensed Product [**]; (ii) the expiration of the Regulatory Exclusivity Period in such country for such Licensed Product; and (iii) the tenth (10th) anniversary of the First Commercial Sale of the first Licensed Product in such country.
1.154.    Rules” has the meaning set forth in Section 13.5.2.

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1.155.    Sanofi has the meaning set forth in the preamble hereto.
1.156.    Sanofi Competitor” means a Third Party that (i) is a Major Pharmaceutical Company or is an Affiliate of a Major Pharmaceutical Company and (ii) actively commercializes in the United States one or more approved pharmaceutical product(s) for [**], which commercialization generated more than [**] in annual sales revenue in the most recently completed Calendar Year as of the closing of the applicable Change of Control transaction, or an Affiliate of any such Third Party.
1.157.    Sanofi Know-How means all Information and Inventions Controlled by Sanofi or any of its Affiliates during the Term that are (i) developed by Sanofi or any of its Affiliates or its or their Sublicensees under this Agreement or (ii) Information and Inventions other than those described in the foregoing clause (i) that are used by Sanofi or any of its Affiliates or its or their Sublicensees for the Exploitation of Licensed Product(s) after the Effective Date and during the Term, but in the case of clause (ii) shall exclude Know-How specifically related to any device, device technology or active pharmaceutical ingredients other than the Licensed Compounds; provided that Sanofi Know-How excludes Joint Know-How.
1.158.    Sanofi Patents means all of the Patents Controlled by Sanofi or any of its Affiliates during the Term, that (i) Cover inventions that are made or conceived by Sanofi or any of its Affiliates or its or their Sublicensees under this Agreement after the Effective Date and during the Term or (ii) are Patents other than those described in the foregoing clause (i) that Cover technologies applied to or incorporated by Sanofi, its Affiliates or its or their Sublicensees into Licensed Products, but this clause (ii) shall exclude Patents specifically related to any device, device technology or active pharmaceutical ingredients other than the Licensed Compounds; provided that Sanofi Patents exclude Joint Patents.
1.159.    Sanofi Product Data” has the meaning set forth in Section 12.5.1(iii).
1.160.    SDEA” has the meaning set forth in Section 3.2.4.
1.161.    Senior Officer” means, with respect to Lexicon, its Chief Executive Officer and with respect to Sanofi, its Executive Vice President, Global Divisions & Strategic Development (or such other member of Sanofi’s Executive Committee as may be the successor to such responsibilities).
1.162.    SGLT1” or “SGLT2” means the applicable member of the sodium-glucose linked transporter family.
1.163.    Specialist Efforts” has the meaning set forth in Section 4.8.1.
1.164.    Specialists” has the meaning set forth in Section 4.8.1.
1.165.    Study Data” means any and all data (together with the results of analysis thereof) generated as a result of any clinical trial of any Licensed Product.
1.166.    Sublicensee means a Person, other than an Affiliate or a Distributor, that is granted a sublicense by Sanofi or its Affiliate under the grants in Section 2.1, as provided in Section 2.3.
1.167.    Supply Agreement” means any agreement entered into between the Parties with respect to supply of Licensed Compound, Licensed Product, placebo or comparator including pursuant to Section 6.1.1.

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1.168.    T1DM” means type 1 diabetes.
1.169.    T1DM Commercialization Plan” has the meaning set forth in Section 4.3.
1.170.    T1DM Funding Agreements” means (a) the Clinical Development Funding Agreement, dated May 2, 2012, by and between Lexicon and McNair Medical Institute, LLC and (b) the Development Agreement, dated June 27, 2014, by and between Lexicon and JDRF International.
1.171.    T1DM Net Sales” means Net Sales attributable to sales of Licensed Products for the treatment of T1DM patients in the (Co-)Promotion Territory as determined pursuant to Section 7.8.
1.172.    T2DM” means type 2 diabetes.
1.173.    T2DM Commercialization Plan” has the meaning set forth in Section 4.3.
1.174.    T2DM CVOT” means that certain cardiovascular outcomes trial for the LX4211 Product in T2DM set forth in the Development Plan.
1.175.    T2DM Net Sales” means all Net Sales in the Territory other than T1DM Net Sales. For clarity, T2DM Net Sales shall not be restricted to Net Sales in T2DM, but shall include Net Sales in all indications other than T1DM.
1.176.    Technology Transfer” has the meaning set forth in Section 6.2.
1.177.    Technology Transfer Agreement” has the meaning set forth in Section 6.4.
1.178.    Term” has the meaning set forth in Section 12.1.
1.179.    Terminated Product” means a Licensed Product with respect to which this Agreement is terminated in its entirety or in one or more Terminated Territory(-ies) pursuant to ARTICLE 12. In the case of termination of this Agreement with respect to a Licensed Product in less than the entire Territory, such Licensed Product shall be considered a Terminated Product only in the Terminated Territory(-ies). In the case of a termination of this Agreement in its entirety, all Licensed Products shall be considered Terminated Products.
1.180.    Terminated Territory” means the country(ies) with respect to which this Agreement is terminated pursuant to ARTICLE 12 or, if this Agreement is terminated in its entirety, the entire Territory.
1.181.    Territory means the entire world, other than the Terminated Territory.
1.182.    Third Party means any Person other than Lexicon, Sanofi and their respective Affiliates.
1.183.    Third Party Acquirer” has the meaning set forth in Section 13.3.2.
1.184.    Third Party Acquirer Family” has the meaning set forth in Section 13.3.2(i).
1.185.    Third Party Claims has the meaning set forth in Section 11.1.

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1.186.    Third Party Infringement Claim has the meaning set forth in Section 8.7.
1.187.    Third Party Payments has the meaning set forth in Section 7.3.3(ii).
1.188.    Third Party Right has the meaning set forth in Section 8.8.
1.189.    Tier 2 Countries” means all current and future member countries of the European Union, the European Free Trade Association, or the Commonwealth of Independent States, Brazil, Russia, India, China, South Korea, Australia, New Zealand, Canada, Mexico, Chile, Argentina, Turkey, Taiwan, Singapore, Saudi Arabia, Kuwait, United Arab Emirates, Qatar, and Israel.
1.190.    Trademark means any word, name, symbol, color, shape, designation or any combination thereof, including any trademark, service mark, trade name, brand name, sub-brand name, trade dress, product configuration, program name, delivery form name, certification mark, collective mark, logo, tagline, slogan, design or business symbol, that functions as an identifier of source or origin, whether or not registered and all statutory and common law rights therein and all registrations and applications therefor, together with all goodwill associated with, or symbolized by, any of the foregoing.
1.191.    Transferred Materials” has the meaning set forth in Section 2.4.1.
1.192.    United States” or “U.S.” means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico).
1.193.    Valid Claim” means a claim of any issued and unexpired (i) Sanofi Patent that meets the criteria set forth in clause(i) of Section 1.158, (ii) Lexicon Patent or (iii) Joint Patent, in each case ((i) through (iii)) existing in the country in the Territory in which the Licensed Product is sold to a Third Party at the time of such sale, which Sanofi Patent, Lexicon Patent or Joint Patent Covers the applicable Licensed Product, in each case the validity, enforceability or patentability of which has not been revoked, found or held unenforceable, invalid or unpatentable by a court, governmental agency, national or regional patent office or other appropriate body having competent jurisdiction in a decision for which no appeal can or has been taken, and which has not been affected or rendered unenforceable through disclaimer, irretrievable lapse, abandonment or dedication to the public.
1.194.    VAT has the meaning set forth in Section 7.11.2.
1.195.    Voting Stock has the meaning set forth in Section 1.23.


ARTICLE 2
GRANT OF RIGHTS

2.1.    Grants to Sanofi. Lexicon hereby grants to Sanofi:
2.1.1.    an exclusive (including with regard to Lexicon and its Affiliates, but subject to a retained right by Lexicon and its Affiliates to exercise their rights and perform their obligations with respect to Licensed Products under this Agreement) license (or sublicense), with the right to grant sublicenses in accordance with Section 2.3, under the Lexicon Patents, the Lexicon Know-How and Lexicon’s interests in the Joint Intellectual Property Rights, to Exploit Licensed Products (and, for clarity,

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the Licensed Compounds contained therein) for any and all uses in the Field in the Territory and, in the case of any Terminated Territory, to Develop and Manufacture Licensed Products (including the Licensed Compounds contained therein) in any country in the Terminated Territory in support of Development and Commercialization in the Field in the Territory; and
2.1.2.    an exclusive (including with regard to Lexicon and its Affiliates, but subject to a retained right by Lexicon and its Affiliates to exercise their rights and perform their obligations with respect to Licensed Products under this Agreement) license (or sublicense) and right of reference, with the right to grant sublicenses and further rights of reference in accordance with Section 2.3, under the Retained Regulatory Documentation to Exploit Licensed Products in the Field in the Territory and, in the case of any Terminated Territory, to Develop and Manufacture Licensed Products in any country in the Terminated Territory in support of Development and Commercialization in the Field in the Territory.
Lexicon agrees, pursuant to a separate trademark license agreement to be negotiated by the Parties, but for no additional financial consideration, to grant to Sanofi a royalty-free, non-exclusive license to use Lexicon’s Corporate Names solely as required by this Agreement or Applicable Law in order to Manufacture the Licensed Products (including the Licensed Compounds contained therein) in the Field in the Territory and for no other purpose.
2.2.    Grants to Lexicon. Sanofi hereby grants to Lexicon a non-exclusive, royalty-free (sub)license and right of reference, without the right to grant sublicenses or further rights of reference (except to permitted subcontractors as provided in Section 3.1.5), under the Sanofi Patents, the Sanofi Know-How and the Assigned Regulatory Documentation and Sanofi’s interests in the Joint Intellectual Property Rights, to perform Lexicon’s obligations as set forth herein or in the Ancillary Agreements. Except as expressly provided herein, Sanofi grants no other right or license, including any rights or licenses to the Sanofi Patents, the Sanofi Know-How, Sanofi’s interest in the Joint Intellectual Property, Assigned Regulatory Documentation or any other Patent or intellectual property rights not otherwise expressly granted herein.
2.3.    Sublicenses. Sanofi shall have the right to grant sublicenses (or further rights of reference) to its Affiliates throughout the Territory. In the Major Markets (except with respect to Manufacturing of the Licensed Product or Licensed Compounds in the Major Markets), for so long as the applicable Major Market remains part of the Territory, Sanofi shall have the right to grant sublicenses (or further rights of reference) to Third Parties (other than to service providers) only with Lexicon’s prior written consent, such consent not to be unreasonably withheld, conditioned or delayed. In all other cases, including service providers and Manufacturing worldwide, Sanofi shall have the right to grant sublicenses (or further rights of reference) to Third Parties, through multiple tiers of (sub)licensees, under the licenses and rights of reference granted in Section 2.1; provided however, that Sanofi shall provide Lexicon with prompt written notice of any such sublicense (or further right of reference). Notwithstanding any sublicenses granted by Sanofi, Sanofi shall remain responsible and primarily liable for the performance of its obligations and the performance of its (sub)licensees hereunder.
2.4.    Disclosure of Know-How and Regulatory Documentation
2.4.1.    Lexicon shall and shall cause its Affiliates and Lexicon CMOs to disclose and make available to Sanofi, the Regulatory Documentation, Lexicon Know-How and other Information and Inventions, in each case, as set forth on Schedule 2.4 and existing as of the Effective Date (the materials required to be disclosed under this sentence, “Transferred Materials”) within [**] after the

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Effective Date. During the Term, each Party shall provide to the other Party all material Sanofi Know-How and Lexicon Know-How, as the case may be, that is reasonably necessary or useful for the other Party to perform its activities under this Agreement or any Ancillary Agreement and that comes into existence after the Effective Date, promptly after the earlier of the development, making, conception or reduction to practice of such Know-How. During the Term, each Party shall provide to the other Party Joint Know-How that comes into existence after the Effective Date, promptly after the earlier of the development, making, conception or reduction to practice of such Joint Know-How by or on behalf of such disclosing Party.  
2.4.2.    Lexicon shall provide Sanofi with reasonable assistance required in order to transfer to Sanofi the Transferred Materials in a timely manner for Sanofi to Exploit the Licensed Products (including for clarity any adjustment to Lexicon’s existing Regulatory Documentation reasonably required by Sanofi). Without limiting the foregoing, Lexicon shall make available to Sanofi, at Lexicon’s facilities, those of Lexicon’s representatives as Sanofi may reasonably request for purposes of transferring the Transferred Materials to Sanofi or for purposes of Sanofi acquiring expertise on the practical application of such Transferred Materials or assisting on issues arising during such Exploitation.
2.4.3.    All costs and expenses of Lexicon’s internal personnel and other resources and any out‑of‑pocket expenditures incurred by Lexicon in performing its obligations pursuant to this Section 2.4 shall be the responsibility of Lexicon; provided, however, that Sanofi shall be responsible for any payments required to be made to Third Parties in connection with such transfers to the extent incurred by Lexicon after the Effective Date.
2.4.4.    Within [**] following the Effective Date, the Parties shall create a mutually acceptable transfer plan, detailing the timeline and responsibilities of both Parties in connection with the transfer of the Transferred Materials from Lexicon to Sanofi (the “Know-How Transfer Plan”); provided, however, that the failure to create a Know-How Transfer Plan shall not relieve Lexicon of its obligations to conduct the disclosures and transfers contemplated by this Section 2.4.
2.5.    Confirmatory Patent License. Lexicon shall, if requested to do so by Sanofi, immediately enter into confirmatory license agreements in such form as may be reasonably requested by Sanofi for purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as Sanofi considers appropriate. Until the execution of any such confirmatory licenses, so far as may be legally possible, Lexicon and Sanofi shall have the same rights in respect of the Lexicon Patents and be under the same obligations to each other in all respects as if the said confirmatory licenses had been executed.
2.6.    Exclusivity
2.6.1.    Neither Party nor any of its Affiliates shall, itself or through, with or on behalf of any Third Party, undertake in the Territory during the Royalty Term in the applicable country (i) any clinical Development of any SGLT1, SGLT2 or dual SGLT1/SGLT2 inhibitors that are not Licensed Products (a “Competing Product”), except clinical Development of a Competing Product (including the manufacture of validation batches thereof) conducted prior to the expiration of the Royalty Term in the applicable country reasonably in advance of the expiration of the Royalty Term in order to launch such Competing Product promptly following expiration of the Royalty Term or (ii) in the case of the Major Markets and the Tier 2 Countries, commercialization of any Competing Product, other than (a) pursuant to this Agreement, (b) in the case of Sanofi, Development and commercialization of a Generic Version of a

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Competing Product in a country after the date on which there is no valid and unexpired Patent in such country that Covers (i) [**] or (ii) [**], (c) in the case of Sanofi, fee-for-service manufacturing of Competing Product(s) for Third Parties, or (d) in the case of Lexicon, and subject to Section 2.7, Development and commercialization of LX2761.
2.6.2.    Notwithstanding Section 2.6.1, if a Party or any of its Affiliates (the “Acquiring Party”) signs a definitive agreement with respect to a merger, acquisition or other transaction by which such Acquiring Party would acquire rights (other than residual financial rights) or an entity that has rights in a Competing Product, or would be acquired by an entity that has or has Affiliates that have rights in a Competing Product, as a result of which transaction Section 2.6.1, would (but for this Section 2.6.2) be violated, then the Acquiring Party (or other acquiring or surviving entity), as the case may be, shall have [**] from the closing of such transaction to either (i) divest itself of the rights with respect to the applicable restricted activities as described in 2.6.1 (the “Restricted Rights”) or (ii) terminate all of such restricted activities with respect to such Competing Product, unless the other Party (i.e., the non-Acquiring Party) agrees in writing that such divestiture is not required. In such event, during such period (or in the case of such a writing from the other Party), the activities described in Section 2.6.1, with respect to such Competing Product shall not constitute a violation of Section 2.6.1. Any divestiture under this Section 2.6.2 may occur by either (x) an outright sale of the Restricted Rights to a Third Party, or (y) an out-license of the Restricted Rights (exclusive as to the Acquiring Party (or other acquiring or surviving entity) and its Affiliates, except that in each case ((x) and (y)) (A) the Acquiring Party (or other acquiring or surviving entity) and its Affiliates may continue manufacturing or supplying the applicable Competing Product to the licensee or acquirer for a reasonable period of time, and conduct customary transitional services for the licensee or acquirer, as applicable, but may not otherwise continue to participate in Development or commercialization of the Competing Product, and (B) the Acquiring Party (or other acquiring or surviving entity) and its Affiliates may retain residual financial rights to such Competing Product and reversion rights in the case of a termination of the out-license agreement (provided that upon such a reversion, the Acquiring Party would again be subject to the divestiture/termination requirements of this Section 2.6.2 if Section 2.6.1 were to apply upon such reversion).
2.7.    LX2761 Rights
2.7.1.    Development and Commercialization by Lexicon. Except for the promotional restrictions set forth in the (Co-)Promotion Terms, nothing in Section 2.6 or elsewhere in this Agreement shall restrict Lexicon from Developing and commercializing, at Lexicon’s sole discretion, LX2761 and products that include LX2761, subject to Lexicon’s obligations and Sanofi’s rights as set forth in this Section 2.7. Lexicon agrees that its Development activities under this Agreement with respect to LX4211 shall have priority over the Development of LX2761, and that Lexicon shall not prioritize LX2761 in any manner detrimental to its Development obligations with respect to LX4211 or divert material resources from its Development of LX4211 under the T1DM Development Plan without the consent of Sanofi. Except as otherwise agreed by the Parties in a definitive agreement entered into by the Parties pursuant to Section 2.7.2 or Section 2.7.3, and notwithstanding anything to the contrary elsewhere in this Agreement, all LX2761 Study Data (as defined below) shall be solely owned by Lexicon. Lexicon shall provide Sanofi a development plan describing Lexicon’s Development activities with respect to LX2761 prior to commencing clinical development for LX2761 and thereafter shall provide Sanofi with any material amendments to such development plan until Sanofi has no further option or rights hereunder with respect to the Development and commercialization of LX2761. Lexicon shall not enter into any agreements with any Third Parties that would deprive Sanofi of its rights under this Section 2.7.

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2.7.2.    Sanofi Initial Right of First Negotiation after PoC. Sanofi shall have an initial right of first negotiation to opt-in to the further Development and commercialization of LX2761 if Lexicon Develops LX2761 in T1DM or T2DM through PoC Successful Completion, in accordance with the following:
(i)    Lexicon shall provide Sanofi with prompt written notice following PoC Successful Completion. Within [**] after such notice, Sanofi shall provide Lexicon with written notice as to whether or not Sanofi is exercising its initial right of first negotiation with respect to LX2761 as provided in this Section 2.7.2.
(ii)    If Sanofi exercises such right of first negotiation, Lexicon shall promptly provide Sanofi with access, to the extent reasonably required to permit fulsome due diligence, to data (together with the results of analysis thereof) generated in Lexicon’s pre-clinical and clinical studies of LX2761, including study reports and, if requested by Sanofi, raw data (the “LX2761 Study Data”) which is then available to Lexicon, a statement of LX2761 Development Costs incurred between the Effective Date and PoC Successful Completion (the “ROFN1 Development Costs”), and Lexicon’s then-current plan for the further Development of LX2761. Lexicon shall also make its personnel and additional material information relating to the LX2761 program reasonably available to Sanofi upon Sanofi’s request to assist Sanofi with its due diligence of the LX2761 program. Sanofi shall have a right to audit the ROFN1 Development Costs pursuant to Section 7.14.
(iii)    Upon written notice from Sanofi that Sanofi desires to negotiate terms for further Development and commercialization of LX2761, which notice must be provided by Sanofi to Lexicon within [**] after Lexicon first makes the LX2761 Study Data available to Sanofi pursuant to paragraph (ii) above, the Parties shall commence good faith negotiations for a definitive agreement under which Lexicon would grant Sanofi an exclusive license for the further Development and commercialization of LX2761 on a worldwide basis with such exceptions as may be agreed by the Parties in writing. Such agreement shall include an upfront payment from Sanofi to Lexicon equal to [**]. Except to the extent otherwise agreed by the Parties, such agreement shall also provide for the following:
(1)    If the Parties agree on a development plan designed to achieve regulatory approval for both T1DM and T2DM, then Lexicon would [**] and Sanofi would [**];
(2)    If the Parties agree on a development plan designed to achieve regulatory approval in T1DM but not T2DM, then Lexicon and Sanofi would [**];
(3)    If the Parties agree on a development plan designed to achieve regulatory approval in T2DM but not T1DM, then Lexicon would [**] and Sanofi would [**].
Additional terms of such definitive agreement, including milestones and royalties to be paid to Lexicon and Lexicon’s participation in the promotion of resulting products comprised of or containing LX2761, shall be subject to good faith negotiations between the Parties.
(iv)    If Sanofi does not exercise its right of first negotiation pursuant to paragraph (i), does not notify Lexicon that it desires to proceed with the negotiation of a definitive agreement providing for the further Development and commercialization of LX2761 pursuant to paragraph (iii), or fails to provide timely notice pursuant to paragraph (i) or (iii) of this Section 2.7.2, or if the Parties agree to cease negotiations or do not enter into a definitive license agreement under paragraph (iii) of this Section 2.7.2 within [**] after such negotiations commence (unless such period is extended by the mutual agreement of

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the Parties in writing), then Lexicon shall have the right to further Develop and commercialize LX2761 in T1DM or T2DM, subject (if applicable) to Sanofi’s second right of first negotiation pursuant to Section 2.7.3 (but free of any and all other obligations to Sanofi with respect to LX2761 other than as described in Section 2.7.1), at Lexicon’s option in its sole discretion.
2.7.3.    Sanofi Second Right of First Negotiation. If the Parties do not enter into a definitive agreement providing for the further Development and commercialization of LX2761 pursuant to Section 2.7.2 and Lexicon further Develops LX2761 in T2DM following PoC Successful Completion pursuant to Section 2.7.2(iv), then, following P3 Successful Completion, and in the event (and only in the event) Lexicon achieves P3 Successful Completion within [**] after the Effective Date, Sanofi shall have a second right of first negotiation to opt-in to the further Development and commercialization of LX2761, in accordance with the following:
(i)    Lexicon shall provide Sanofi with prompt written notice of the achievement of P3 Successful Completion. Within [**] after such notice, Sanofi shall provide Lexicon with written notice as to whether or not Sanofi is exercising its second right of first negotiation with respect to LX2761 as provided herein.
(ii)    If Sanofi exercises such right of first negotiation, Lexicon shall promptly provide Sanofi with access, to the extent reasonably required to permit fulsome due diligence, to LX2761 Study Data that has been generated by Lexicon (including study reports and, if requested by Sanofi, raw data), a statement of LX2761 Development Costs incurred with respect to T2DM between the Effective Date and P3 Successful Completion (the “ROFN2 Development Costs”), and Lexicon’s then-current plan for the further Development of LX2761. Lexicon shall also make its personnel and additional material information relating to the LX2761 program reasonably available to Sanofi upon Sanofi’s request to assist Sanofi with its due diligence of the LX2761 program. Sanofi shall have a right to audit the ROFN2 Development Costs pursuant to Section 7.14.
(iii)    Upon written notice from Sanofi that Sanofi desires to negotiate terms for further Development and commercialization of LX2761 in T2DM (and, if applicable, in T1DM outside the United States), which notice must be provided by Sanofi to Lexicon within [**] after Lexicon first makes the LX2761 Study Data available to Sanofi pursuant to paragraph (ii) above, the Parties shall commence good faith negotiations for a definitive agreement under which Lexicon would grant Sanofi an exclusive license for the further Development and commercialization of LX2761 in T2DM (and, if applicable, in T1DM outside the United States). Such agreement shall include an upfront payment from Sanofi to Lexicon equal to [**]. Except to the extent otherwise agreed by the Parties, such agreement shall also provide that Sanofi would assume [**]. Additional terms of such definitive agreement, including milestones and royalties to be paid to Lexicon, Lexicon’s participation in the promotion of resulting products comprised of or containing LX2761 for T2DM, and an additional upfront payment if such agreement includes rights to LX2761 in T1DM outside the United States, shall be subject to good faith negotiations between the Parties.
(iv)    If Sanofi does not exercise its second right of first negotiation pursuant to paragraph (i), does not notify Lexicon that it desires to proceed with the negotiation of a definitive agreement providing for the further Development and commercialization of LX2761 in T2DM pursuant to paragraph (iii), or fails to provide timely notice pursuant to paragraph (i) or (iii) of this Section 2.7.3, or if the Parties agree to cease negotiations or do not enter into a definitive license agreement under paragraph (iii) of this Section 2.7.3 within [**] after such negotiations commence (unless such period is extended by the mutual

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agreement of the Parties in writing), then Lexicon shall have the right to further Develop and commercialize LX2761 in T2DM and T1DM worldwide except as provided in the second sentence of Section 2.7.1 and the promotional restrictions set forth in the (Co-)Promotion Terms, and Sanofi shall have no further option or rights hereunder with respect to the Development and commercialization of LX2761.
(v)    If Sanofi exercises its second right of first negotiation pursuant to Section 2.7.3(i), elects to obtain rights to LX2761 in T1DM outside the United States, and the Parties enter into a definitive agreement with respect thereto, any subsequent Development or commercialization of LX2761 in T1DM by Lexicon outside the United States shall be subject to the terms of such agreement.
ARTICLE 3
DEVELOPMENT AND REGULATORY ACTIVITIES

3.1.    Development
3.1.1.    In General. Except as otherwise provided in this Agreement, Lexicon shall have the sole right and responsibility for all aspects of the Development of Licensed Products for T1DM at its expense (other than regulatory matters, which are governed by Section 3.2) which shall be conducted in accordance with and pursuant to the Development Plan. Otherwise, subject to the Lexicon Consent Right and the other terms of this Agreement, Sanofi shall have the sole right and responsibility for all aspects of the Development of Licensed Products (other than regulatory matters, which are governed by Section 3.2), with Development Costs shared as set forth in Section 7.6, which shall be conducted in accordance with and pursuant to the Development Plan. The Parties shall cooperate in performing such Development activities as provided in this ARTICLE 3.
3.1.2.    Development.
(i)    Attached hereto as Schedule 3.1.2 is the initial plan for the Development of the Licensed Products for T1DM and T2DM in the Major Markets in the Territory as of the Execution Date (such plan, as amended from time to time in accordance with this Agreement, the “Development Plan”), which plan shall describe the Development activities and, with respect to Development activities for T2DM, the budget therefor, including the internal personnel and other resources and out‑of‑pocket expenditures required for Sanofi to perform such activities; provided that upon the earlier of (a) the Cost-Sharing Trigger Point and (b) the date upon which Lexicon has paid one hundred million Dollars ($100,000,000) of Development Costs in connection with T2DM Development under and in accordance with the Development Plan, the Development Plan shall not contain such budget.
(ii)    The JSC shall review the Development Plan at least [**] for the purpose of considering appropriate amendments thereto. In addition, each Party, through its representatives on the JSC, may propose amendments to the Development Plan for Development activities at any time. As part of the process of amending the Development Plan, the JSC shall determine the internal personnel and other resources and out‑of‑pocket expenditures required for Sanofi with respect to Development activities for T2DM for the applicable Calendar Year and for each Calendar Quarter within such Calendar Year. All internal personnel and resources shall be expressed in terms of FTEs and the budgeted cost shall be calculated using the relevant FTE Rates.
(iii)    Under the direction and supervision of the DRC and the JSC as set forth in ARTICLE 5, each Party shall use Commercially Reasonable Efforts to perform the responsibilities

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assigned to it under the Development Plan and shall use Commercially Reasonable Efforts to do so in accordance with the timelines set forth in the Development Plan, in good scientific manner and in compliance with all Applicable Law by allocating sufficient time, effort, equipment, and skilled personnel to complete such Development activities; provided that, (a) with respect to Lexicon, such obligation shall be subject to Sanofi’s and its Affiliates’ performing their respective obligations hereunder and under the Ancillary Agreements on which Lexicon’s performance depends, and (b) with respect to Sanofi, Sanofi shall not be in breach of this Section 3.1.2(iii), to the extent that its failure to perform its obligations under this Section 3.1.2(iii) arises from Lexicon’s and its Affiliates’ failure to perform their respective obligations hereunder and under the Ancillary Agreements on which Sanofi’s performance depends.
(iv)    If Lexicon elects to permanently cease all Development in T1DM before completion of the Development activities set forth in the Development Plan, Lexicon shall promptly notify Sanofi thereof, and Sanofi shall have the right, at Sanofi’s sole election, to assume and complete any such Development activities. If Sanofi exercises such right, such exercise shall be Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability for any such cessation by Lexicon (but this sentence shall not limit any liability of Lexicon for a material breach of this Agreement other than its diligence obligations under Sections 3.1.2(iii) and 3.1.4). If Sanofi so elects to assume and complete any of the Development activities under the Development Plan with respect to T1DM, the actions set forth in the remainder of this Section 3.1.2(iv) shall be Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability for any such cessation by Lexicon (but this sentence shall not limit any liability of Lexicon for a material breach of this Agreement other than its diligence obligations under Sections 3.1.2(iii) and 3.1.4) and, to the extent reasonably requested by Sanofi in writing, Lexicon shall cooperate in facilitating the orderly transfer of such Development activities and ensure that Sanofi obtains the material benefits of any or all Third Party agreements relating to such Development activities, in conformity with any Applicable Law. If Sanofi does not elect to assume any such Development activities, Lexicon shall wind down such Development activities in accordance with Applicable Law at its sole cost and expense. In the event of Lexicon’s cessation of Development in T1DM in accordance with this Section 3.1.2(iv), the licenses granted by Sanofi to Lexicon under Section 2.2, the Parties’ obligations under Section 2.6.1 with respect to T1DM, the Quality Agreements under Section 3.1.2(v), the JCC, Lexicon’s rights under Section 3.2.2 to participate in meetings with Regulatory Authorities, and Lexicon’s (Co-)Promotion Rights under Section 4.8 and any (Co-)Promotion Agreement shall terminate, effective upon Lexicon’s notice with respect thereto; Sanofi shall be responsible for any and all additional T1DM Development Costs (if it exercises its right to assume and continue Development in T1DM) and all T1DM Commercialization Costs and Medical Affairs Costs; Lexicon shall not be entitled to the milestone payments contemplated by Section 7.2.1(b)(i) and Section 7.2.1(b)(ii), to the extent subsequently achieved based on Development activities subsequently conducted by Sanofi under its right to assume and continue such Development; and the royalty rates described in Section 7.3.1(ii) shall apply to all Net Sales in the United States, regardless of whether such Net Sales would otherwise constitute T1DM Net Sales or T2DM Net Sales.
(v)    Quality.
(1)    Within [**] after the Effective Date, but in any event prior to shipment of clinical quantities of Licensed Product or placebo pursuant to Section 6.1.1, Lexicon and Sanofi shall enter into a reasonable and customary Quality Agreement that shall set forth the terms and conditions with respect to quality regarding the conduct of the Parties’ Development activities under the Development Plan, including supply of such clinical material by Lexicon to Sanofi, which agreement shall include (a) coordination regarding inspections by Regulatory Authorities and (b) the exchange of information between the Parties regarding the foregoing and quality issues in general.

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(2)    The Quality Agreements shall provide for each Party’s right to conduct quality audits of the other Party and its subcontractors prior to the Technology Transfer and thereafter with respect to T1DM and T2DM clinical studies, as deemed necessary by the auditing Party to secure the regulatory status of the Licensed Product in the Territory.
(3)    Each Party shall be notified reasonably in advance of any audit or inspection intended to be conducted by a Regulatory Authority at any of the other Party’s or any of its subcontractor’s facilities or operations related to the Development or Manufacture of the Licensed Products. The Parties shall reasonably cooperate with each other with respect to such audits or inspections.
(4)    Promptly following the Effective Date, the Parties shall appoint quality contact persons within their respective organization, with the mission to oversee the negotiation and implementation of the Quality Agreement. The Parties shall maintain scientific records, in sufficient detail and in sound scientific manner appropriate for patent and regulatory purposes and in compliance with Applicable Law with respect to activities intended to be submitted in the context of any Regulatory Approval hereunder. The Quality Agreement shall describe in sufficient detail how the Parties intend to manage any quality-related issues likely to impact the activities to be performed under this Agreement.
3.1.3.    Decision Points and Positive Results for Development Activities. The Development Plan sets forth certain decision points associated with the completion of certain clinical studies (the “Decision Points”). At each Decision Point, within [**] after the earlier of (i) [**] and (ii) [**], the JSC shall determine whether or not Positive Results have been achieved. With respect to a given Decision Point, “Positive Results” means that, based on review of [**] (in the case of clause (i)) or [**] (in the case of clause (ii)), the primary endpoint of the study was achieved (or, in the case of the Initial Data, as applicable, the cardiovascular safety results supporting the filing of a New Drug Application for Regulatory Approval consistent with applicable FDA guidance for cardiovascular safety of diabetes drugs) with overall safety and efficacy supporting continued Development or application for Regulatory Approval. If Positive Results have not been achieved, then (a) Sanofi may elect to terminate this Agreement as set forth in Section 12.3.2(i)(b) or (b) the JSC may elect to immediately discontinue or cancel all or part of any Development activities under the Development Plan that are conditioned on the achievement of Positive Results with respect to the applicable Decision Point, including any ongoing or planned clinical studies or regulatory filings, or to modify the Development Plan as it deems appropriate in good faith, in the interest of securing Regulatory Approval for a Licensed Product in the Field in the Major Markets in the Territory.
3.1.4.    Diligence. Sanofi shall use Commercially Reasonable Efforts to Develop at least one LX4211 Product in the Major Markets in the Territory for T2DM as set forth in the Development Plan, but Sanofi shall not be in breach of this Section 3.1.4 to the extent that a failure to do so arises from Lexicon’s and its Affiliates’ failure to perform their respective obligations hereunder and under the Ancillary Agreements on which Sanofi’s performance depends. Lexicon shall use Commercially Reasonable Efforts to Develop at least one LX4211 Product for T1DM as set forth in the Development Plan, and, subject to the Parties’ incorporating such requirements in the Development Plan, to conduct any Required Phase 4 Studies relating to the United States and European Union Regulatory Approvals, subject to Sanofi’s and its Affiliates’ performing their respective obligations hereunder and under the Ancillary Agreements and subject to Lexicon’s right to cease such Development under Section 3.1.2(v). Each Party acknowledges and agrees that nothing in this Section 3.1.4 is intended, or shall be construed, to require the other Party to Develop more than one Licensed Product at any given time or to Develop any other Licensed Product other than the LX4211 Product.

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3.1.5.    Subcontracting. Each Party shall have the right to subcontract material portions of its Development activities to a Third Party (e.g., engagement of a CRO or clinical manufacturer prior to commencement of clinical activities or commercial Manufacture) (i) to the extent expressly provided for in the Development Plan or Quality Agreements, which shall set forth certain Development activities for which corresponding subcontractors have been pre-approved, or (ii) in the case that such subcontracting has not been pre-approved in the Development Plan, with the approval of the JSC, which approval shall not be unreasonably withheld, conditioned or delayed. Either Party shall have the right to subcontract to a Third Party without approval any of its Development activities to which the foregoing sentence does not apply, and for the avoidance of doubt, the foregoing sentence does not apply to general services not specific to the Licensed Products (e.g., copying and shipping).
3.1.6.    Development Records. Each Party shall maintain, in good scientific manner, complete and accurate books and records pertaining to its Development activities, in sufficient detail to verify compliance with its obligations under this Agreement and which shall be appropriate for patent and regulatory purposes, in compliance with Applicable Law, including good laboratory practices, good manufacturing practices, good pharmacovigilance practices and good clinical practices, and properly reflect all work done and results achieved in the performance of its Development activities. Such books and records shall be retained by Lexicon or Sanofi, as the case maybe, for at least [**] after the expiration or termination of this Agreement in its entirety or for such longer period as may be required by Applicable Law. Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all records of the other Party maintained pursuant to this Section 3.1.6; provided that the inspecting Party shall maintain such records and the information disclosed therein in confidence in accordance with ARTICLE 9.
3.1.7.    Development Reports. Without limiting Section 3.1.6, on a semi-annual basis within [**] after January 1 and July 1 of each Calendar Year during the Term, each Party shall provide to the JSC or DRC, as applicable, a written report of such Development activities conducted by such Party during such Calendar Quarter. Such report shall contain reasonable detail sufficient to enable the JSC or DRC, as applicable, to assess such Party’s performance of activities pursuant to and compliance with the Development Plan, including: (i) the Party’s, or its Affiliates’ or its or their Sublicensees’ activities with respect to achieving Regulatory Approvals of such Licensed Product in the Major Markets in the Territory, (ii) clinical study results and results of other Development activities and (iii) other Development matters listed on Schedule 3.1.7. In addition, each Party shall provide the other Party with prompt notification of material developments arising in the course of Development activities conducted by such Party.
3.2.    Regulatory Activities.
3.2.1.    Regulatory Approvals.
(i)    The Parties shall coordinate in good faith to transfer those INDs owned by Lexicon or its Affiliates relating to the Licensed Compounds or Licensed Products. To effect the foregoing, within [**] after the Effective Date, the DRC shall finalize a plan for the transfer to Sanofi or withdrawal of such INDs, which transfer shall be coordinated with the transfer of required safety and other information hereunder. Once adopted, the Parties shall use their reasonable efforts to effect the plan on the agreed upon timeline.

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(ii)    Except to the extent prohibited by Applicable Law or as otherwise specified herein or agreed by the DRC, all Regulatory Documentation (including all Regulatory Approvals) relating to the Licensed Compounds or Licensed Products with respect to the Territory, other than the Retained Regulatory Documentation, including any retained INDs, shall be owned by and shall be the sole property and held in the name of Sanofi or its Affiliate, Sublicensee or designee.
(iii)    Effective as of the date of transfer of the applicable Regulatory Documentation (including INDs) pursuant to the agreed plan under Section 3.2.1(i), Lexicon hereby assigns to Sanofi all of its right, title and interest to such Regulatory Documentation, including all Existing Regulatory Documentation. Any Regulatory Documentation unless and until assigned pursuant to this Section shall be the “Retained Regulatory Documentation.” Once assigned to Sanofi, such Regulatory Documentation shall be deemed the “Assigned Regulatory Documentation.” Promptly following any such assignment of Regulatory Documentation, Sanofi shall grant to Lexicon such authorizations under the Assigned Regulatory Documentation necessary or desirable to enable Lexicon to perform the Development activities for which Lexicon is responsible under the Development Plan.
(iv)    With regard to any assignments made or required under this Section 3.2.1, Lexicon shall duly execute and deliver or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary under or as Sanofi may reasonably request in connection with or to carry out more effectively the purpose of or to better assure and confirm unto Sanofi its rights under this Section 3.2.1. In addition, concurrent with the assignments described in this Section 3.2.1, with respect to any IND to be transferred to Sanofi, Lexicon shall deliver to Sanofi a letter to the applicable Regulatory Authority transferring to Sanofi the applicable IND, which letters shall be mutually agreed upon by the Parties in advance of the transfer of the applicable IND.
(v)    The holder of any IND or Drug Approval Application shall be considered the “Approval Holder”. The Approval Holder or its designee shall own such IND or Drug Approval Application and shall have the sole right and responsibility, at its sole expense, to make all other submissions with the Regulatory Authorities relating thereto. In the case in which Lexicon is the Approval Holder, it shall take direction from Sanofi with regard to T2DM and otherwise comply with this Agreement. Unless otherwise agreed, the Approval Holder shall have the right to conduct all meetings (subject to Section 3.2.2) and correspondence and communications with Regulatory Authorities regarding matters relating to such Drug Approval Applications as to which it is the Approval Holder. The Approval Holder shall report all Adverse Events to Regulatory Authorities if and to the extent required by Applicable Law under such Drug Approval Applications as to which it is the Approval Holder.
(vi)    Lexicon shall only use any Retained Regulatory Documentation in a manner consistent with this Agreement to perform its obligations hereunder and agrees to comply with Applicable Law with respect thereto and act at the reasonable direction of Sanofi and otherwise reasonably cooperate with Sanofi in order to afford to Sanofi the benefits of such Retained Regulatory Documentation as if it were held in the name of Sanofi, including making any filings as reasonably requested by Sanofi to enable Sanofi to commence Development Activities as contemplated in the Development Plan under any Retained Regulatory Documentation.
(vii)    Following, and subject to, the successful completion by the Parties of the Development activities in accordance with the Development Plan with respect to T2DM or T1DM, as the case may be, for the LX4211 Product, Sanofi shall use Commercially Reasonable Efforts to obtain

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Regulatory Approval for the LX4211 Product in the Major Markets in the Territory (in the case of the European Major Markets, such Regulatory Approval may be a centralized Regulatory Approval from the European Commission) for such indication, but shall be excused from such obligation to the extent Lexicon has failed to perform its obligations hereunder and under the Ancillary Agreements upon which Sanofi is expecting to rely in connection with the applicable Sanofi activity.
(viii)    Lexicon shall cooperate and support Sanofi, as may be reasonably necessary, in obtaining Regulatory Approvals for the Licensed Products and in the activities in support thereof, including providing all documents or other materials in the possession or control or Lexicon or any of its Affiliates, Lexicon CMOs or Lexicon CROs and participating in regulatory meetings at the request of Sanofi, in each case, as may be necessary or useful for Sanofi or any of its Affiliates or its or their Sublicensees to obtain Regulatory Approvals for the Licensed Products. Lexicon shall invoice Sanofi for, and Sanofi shall pay to Lexicon within [**] following any such invoice, the out-of-pocket costs and expenses incurred by Lexicon and payable to Third Parties in connection with providing any such cooperation, support or participation requested by Sanofi. For clarity, such reimbursement applies only to out-of-pocket costs incurred in connection with providing cooperation pursuant to the foregoing and not in connection with the exercise of any rights under this Agreement by Lexicon. Any such costs shall be considered Development Costs incurred by Sanofi for purposes of Section 7.6.
(ix)    The Approval Holder shall provide the Party that is not the Approval Holder with a reasonable opportunity to review and comment on all major regulatory submissions and documents (i.e., INDs, Drug Approval Applications, material labeling supplements, Regulatory Authority meeting requests and core data sheets) submitted to the Regulatory Authorities in the Major Markets in the Territory (including the EMA).
(x)    The Approval Holder shall consider in good faith any such comments of the other Party and otherwise act in a manner consistent with this Agreement.
(xi)    Sanofi shall notify Lexicon of the filing and approval of any Drug Approval Application for a Licensed Product or major supplements or amendments thereto with or by a Regulatory Authority in a Major Market in the Territory (or the European Commission or EMA, as applicable), promptly after the filing or approval thereof.
3.2.2.    Meetings with Regulatory Authorities. The Approval Holder has the right and responsibility to prepare for and lead all meetings with Regulatory Authorities regarding the Licensed Compounds and Licensed Products under the Regulatory Approvals as to which it is the Approval Holder; provided that, subject to Applicable Law, the other Party shall have the right to participate fully in all such meetings until completion of the Core Development Plan, unless such activities have been abandoned by the Parties hereunder, and, at the reasonable request of the Approval Holder, shall participate fully in all such meetings led by the Approval Holder. Except to the extent prohibited by Applicable Law, until completion of the Core Development Plan, unless such activities have been abandoned by the Parties hereunder, the Approval Holder shall afford the other Party a reasonable period of time to review and comment on all substantive communications with Regulatory Authorities by or on behalf of the Approval Holder and its Affiliates (including at such meetings and in anticipation of such meetings). Until completion of the Core Development Plan, unless such activities have been abandoned by the Parties hereunder, each Party shall notify the other Party at least [**] (or shorter if such notice period is not practicable) in advance of any meeting with Regulatory Authorities to which it becomes aware regarding the Licensed Compounds, Licensed Products or Development activities.

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3.2.3.    Recalls, Suspensions or Withdrawals. In the event that any government agency or authority issues or requests a recall or takes similar action in connection with the Licensed Compounds or the Licensed Products, or in the event either Party determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal, the Party notified of or desiring such recall or market withdrawal shall as promptly as reasonably practical under the circumstances advise the other Party thereof. As between the Parties, Sanofi shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension or market withdrawal in the Territory. If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as between the Parties, Sanofi shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or market withdrawals undertaken pursuant to this Section 3.2.3, as between the Parties, Sanofi shall be solely responsible for the execution and Lexicon shall reasonably cooperate in all such efforts. Subject to ARTICLE 11, Sanofi shall be responsible for all costs of any such recall, market suspension or market withdrawal, except to the extent that a recall, market suspension or market withdrawal resulted from Lexicon’s or its Affiliate’s breach of its obligations hereunder or under any Ancillary Agreement or from Lexicon’s or its Affiliate’s or subcontractor’s breach of this Agreement or its negligence or willful misconduct, in which case, Lexicon shall bear the expense of such recall, market suspension or market withdrawal.
3.2.4.     Global Safety Database. Promptly after the Effective Date, in accordance with a plan to be established by the DRC in coordination with the transfer of Regulatory Documentation contemplated by Section 3.2.1, Lexicon shall transfer the global safety database for Licensed Products to Sanofi. Prior to such transfer, Lexicon shall bear the costs and expenses of holding and maintaining such global safety database. Following such transfer, Sanofi shall hold and maintain such global safety database (at Sanofi’s expense, except to the extent included in the Development Plan). Each Party shall provide the other Party with all information necessary or desirable for such other Party to comply with its pharmacovigilance responsibilities in the Territory, including, as applicable, any Adverse Events or other adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. sections 312.32 or 314.80 or to other Regulatory Authorities under corresponding Applicable Law outside the United States), from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical studies and commercial experiences with a Licensed Product, in each case in the form reasonably requested by such other Party. The Parties shall promptly negotiate, and no later than the first dosing of the first human subject in clinical studies commenced after the Execution Date for a Licensed Product for T2DM or as otherwise required by Applicable Law, enter into a reasonable and customary safety data exchange agreement (the “SDEA”), which shall describe the responsibilities and detailed procedures to be followed by the Parties with regard to all pharmacovigilance obligations to ensure safety surveillance for the Licensed Products under this Agreement.
ARTICLE 4
COMMERCIALIZATION

4.1.    In General. As between the Parties, Sanofi (itself or through its Affiliates or its or their Sublicensees) shall have the sole right to Commercialize Licensed Products in the Territory at its sole cost and expense, subject to Lexicon’s (Co-)Promotion Right pursuant to the (Co-)Promotion Agreement.
4.2.    Diligence. Sanofi shall use Commercially Reasonable Efforts to Commercialize the LX4211 Product in the Major Markets in the Territory for T1DM and T2DM, following receipt of Regulatory Approval for the applicable indication in the applicable country; provided that if Lexicon

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exercises the (Co-)Promotion Right, Sanofi’s obligation to use Commercially Reasonable Efforts shall not extend to the responsibilities allocated to Lexicon under the (Co-)Promotion Agreement and applicable T1DM Commercialization Plan; provided further Sanofi shall be excused from such obligation to the extent Lexicon fails to perform its obligations on which Sanofi’s performance depends. If Lexicon exercises the (Co-)Promotion Right, Lexicon shall use Commercially Reasonable Efforts to perform its obligations in the United States under the T1DM Commercialization Plan. Without limiting Sanofi’s obligations hereunder, Sanofi shall promptly notify Lexicon of any decision to cease using Commercially Reasonable Efforts to Commercialize any Licensed Product in any Major Market in the Territory. Lexicon acknowledges and agrees that nothing in this Section 4.2 is intended, or shall be construed, to require Sanofi to Commercialize more than one Licensed Product at any given time or to Commercialize any other Licensed Product other than the LX4211 Product. If Sanofi implements and uses Commercially Reasonable Efforts to carry out its responsibilities under the T1DM Commercialization Plan pursuant to Section 4.3, Sanofi shall be deemed to have satisfied its obligation to use Commercially Reasonable Efforts under this Section 4.2 and shall have no liability resulting from any failure of the activities described in the T1DM Commercialization Plan.
4.3.    Commercialization Plan No later than [**] prior to the anticipated First Commercial Sale of a Licensed Product for T1DM, (i) if Lexicon has exercised the (Co-)Promotion Right, (a) Lexicon shall prepare and provide to the JCC for review and discussion a proposed written plan for the Commercialization of the Licensed Product for T1DM in the (Co-)Promotion Territory, which shall include a reasonably detailed description of the Parties’ anticipated Commercialization activities and Medical Affairs Activities relating to T1DM in the (Co-)Promotion Territory, and the anticipated timeline and budget therefor and (b) Sanofi shall prepare and provide to the JCC for review and discussion a proposed written plan for the Commercialization of the Licensed Product for T1DM in the Territory outside of the (Co-)Promotion Territory, which shall include global branding strategy and a launch plan, or (ii) if Lexicon has not exercised the (Co-)Promotion Right, Sanofi shall prepare and provide to the JCC for review and discussion a proposed written plan for the Commercialization of the Licensed Product for T1DM in the Territory, which shall include a global branding strategy and a launch plan (in either case, ((i) or (ii)) the “T1DM Commercialization Plan”). No later than [**] prior to the anticipated First Commercial Sale of a Licensed Product for T2DM, Sanofi shall prepare and provide to the JCC for review and discussion a written plan for the Commercialization of the Licensed Product for T2DM in the Territory, which shall include global branding strategy and a launch plan and, if Lexicon has exercised the (Co-)Promotion Right, a reasonably detailed description of Sanofi’s anticipated Commercialization activities and Medical Affairs Activities relating to T2DM in the (Co-)Promotion Territory (the “T2DM Commercialization Plan”). The T1DM Commercialization Plan and the T2DM Commercialization Plan are sometimes referred to herein individually as a “Commercialization Plan” and collectively as the “Commercialization Plans”. The Party that initially prepared the applicable Commercialization Plan pursuant to this Section 4.3 above shall periodically (at least on an [**] basis) prepare updates and amendments to such Commercialization Plan to reflect changes in its plans, including in response to changes in the marketplace, relative success of the Licensed Product for T1DM or T2DM, as applicable, and other relevant factors influencing such plans and activities, and shall submit such updates and amendments to the JCC for review and discussion (which shall include the coordination of strategies for Commercialization activities and Medical Affairs Activities across the T1DM and T2DM indications pursuant to Section 5.4.1) before adopting such updates and amendments.
4.4.    Booking of Sales; Distribution As between the Parties, Sanofi shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehouse and distribute the Licensed Products in the Territory and perform or cause to be performed all related

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services. As between the Parties, Sanofi shall handle all returns, recalls or withdrawals, order processing, invoicing, collection, distribution and inventory management with respect to the Licensed Products in the Territory.
4.5.    Statements and Compliance with Applicable Law. Each Party shall and shall cause its Affiliates to, comply with all Applicable Law with respect to its Commercialization of Licensed Products hereunder.
4.6.    Subcontracting; Distributors. Subject to Section 2.3 and Lexicon’s (Co-)Promotion Right pursuant to the (Co-)Promotion Agreement, each Party shall have the right to subcontract any of its Commercialization activities to a Third Party (including by appointing one or more contract sales forces or, in the case of Sanofi, co-promotion partners or Distributors); provided, however, neither Party may subcontract more than [**] of its Detailing efforts with respect to Licensed Products under this Agreement or the (Co-)Promotion Agreement to a Third Party, without the prior written consent of the other Party.
4.7.    Leadership of T1DM Commercialization and Medical Affairs Activities in the (Co-)Promotion Territory. In the event Lexicon exercises its (Co-)Promotion Right, from and after such exercise until the expiration or earlier termination of the (Co-)Promotion Agreement, unless otherwise agreed by the Parties and subject to oversight by the JCC and the JSC and subject to the dispute resolution procedures in Section 13.5, Lexicon shall be assigned a lead role in the oversight, execution and management of (i) Commercialization activities under the T1DM Commercialization Plan other than (a) the sales and sales management efforts and (b) pricing and market access encompassed by the (Co-)Promotion Agreement and (ii) Medical Affairs Activities under the T1DM Commercialization Plan.
4.8.    (Co-)Promotion Agreement.
4.8.1.    (Co-)Promotion Right. Subject to Section 13.3.2(iii), this Section 4.8.1 and the terms of the (Co-)Promotion Agreement, following the first Regulatory Approval of a Licensed Product for T1DM by FDA, Lexicon shall have the right to elect to perform a portion (to be set forth in the T1DM Commercialization Plan) of the (Co-)Promotion efforts to diabetes specialist physicians (e.g., endocrinologists, diabetologists and selected internal medicine or general physicians) (such physicians, “Specialists” and such efforts, “Specialist Efforts”) for Licensed Products for T1DM (the “(Co-)Promotion Product(s)”) in the (Co-)Promotion Territory (the “(Co-)Promotion Right”) in accordance with the terms of the (Co-)Promotion Agreement; provided that, for clarity, Sanofi or its applicable Affiliate or Sublicensee will continue to book one hundred percent (100%) of sales of the Licensed Products. No later than [**] prior to the anticipated First Commercial Sale of the (Co-)Promotion Product(s) for T1DM, Lexicon shall provide to Sanofi in writing details regarding the Lexicon promotional structure, such as the number of Lexicon sales representatives, management structure, regional coverage and activity monitoring system, which details may be included in the T1DM Commercialization Plan.
4.8.2.    Terms of (Co-)Promotion Agreement. In order to exercise the (Co-)Promotion Right, Lexicon shall provide Sanofi of its decision thereof at least [**] prior to the anticipated First Commercial Sale of the (Co-)Promotion Product(s) in the (Co-)Promotion Territory. If Lexicon exercises the (Co-)Promotion Right prior to such date, the Parties shall enter into the (Co-)Promotion Agreement with respect to (Co-)Promotion Products in the (Co-)Promotion Territory (the “(Co-)Promotion Agreement”), the terms of which (Co-)Promotion Agreement shall conform in all material respects with the terms and conditions set forth in Schedule 4.8.2. The Parties will use Commercially

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Reasonable Efforts to negotiate and execute the (Co-)Promotion Agreement no later than [**] before the anticipated First Commercial Sale of the (Co-)Promotion Product in the (Co-)Promotion Territory; provided Sanofi shall be excused from such obligation to the extent Lexicon has failed to perform its obligations hereunder and under the Ancillary Agreements upon which Sanofi’s performance depends.
4.8.3.    Termination of (Co-)Promotion Agreement. Lexicon may terminate the (Co-)Promotion Agreement for Lexicon’s convenience upon [**] prior notice to Sanofi. Sanofi may terminate the (Co-)Promotion Agreement (i) immediately, as of [**] prior to the anticipated First Commercial Sale of the LX4211 Product in the United States for T1DM, in the event of a material failure by Lexicon to implement the promotional structure communicated to Sanofi pursuant to Section 4.8.1 on the required timeline prior to anticipated First Commercial Sale or on the schedule set forth in the (Co-)Promotion Agreement or (ii) as a result of a Change of Control as provided in Section 13.3.2(iii) of this Agreement. The (Co-)Promotion Agreement may also include other customary termination rights.
4.9.    Product Label, Packaging and Promotional Materials. The two names “Sanofi” and “Lexicon” shall be displayed on all Licensed Product label, packaging and promotional materials in the Territory for use in the Field, to the extent permitted by Applicable Law, and shall be displayed in equal prominence on such materials in the United States.
4.10.    Commercialization Reports. With respect to each Licensed Product Developed pursuant to this Agreement, commencing with the Calendar Year in which a Drug Approval Application is first filed with respect to such Licensed Product in any Major Market in the Territory, and for each subsequent Calendar Year thereafter, each Party (in the case of Lexicon, only if Lexicon has exercised the (Co-)Promotion Right) shall provide to the other Party (through the JSC, if the JSC is in place) for such other Party’s review and comment, within [**] following January 1 and July 1 of each Calendar Year during the Term, a written report setting forth in reasonable detail the providing Party’s and its Affiliates’ and Sublicensees’ (a) activities and progress during such preceding [**] period related to the Commercialization of and Medical Affairs activities relating to Licensed Products, including information in such Party’s possession concerning First Commercial Sale of the Licensed Products, achievement of sales milestones, and the territories (by each Major Market in the Territory and the rest of the world) in which the foregoing activities are conducted, such information to be provided separately for each Licensed Product, and (b) any planned Commercialization activities in the next [**] period, including expected timelines.
ARTICLE 5
COLLABORATION MANAGEMENT

5.1.    Joint Steering Committee. Within [**] after the Effective Date, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or “JSC”), which shall consist of three (3) representatives of each Party, each with the requisite experience and seniority to enable such person to make decisions on behalf of the applicable Party with respect to the issues falling within the jurisdiction of the JSC. From time to time, each Party may substitute one or more of its representatives to the JSC on written notice to the other Party. Sanofi shall select from its representatives the chairperson for the JSC, which chairperson may be changed from time to time, on written notice to Lexicon. The JSC shall, with respect to the Licensed Products:

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5.1.1.    periodically serve as a forum for discussing the Development activities, including by reviewing the Development Plan and overseeing the conduct of the Development activities as provided in Section 3.1.2 and reviewing Development reports as provided pursuant to Section 3.1.7;
5.1.2.    review and approve amendments and modifications to the Development Plan;
5.1.3.    review and discuss regulatory matters;
5.1.4.    review and discuss Manufacturing and supply matters;
5.1.5.    periodically serve as a forum for discussing the overall strategy for Licensed Products in the Territory with respect to Commercialization activities and Medical Affairs Activities, including by coordinating such strategy between T1DM and T2DM indications, reviewing Commercialization activities and Medical Affairs Activities, reviewing Commercialization reports as provided pursuant to Section 4.8 and overseeing (Co-)Promotion of the (Co-)Promotion Product(s) in the (Co-)Promotion Territory;
5.1.6.    review and approve amendments and modifications to the Commercialization Plans;
5.1.7.    periodically serve as a forum for discussing the overall strategy for obtaining, maintaining and enforcing Patents and market and data exclusivity for Licensed Products in the Field in the Territory;
5.1.8.    determine at each Decision Point in the Development Plan whether Positive Results have been achieved and advise the Parties in writing of such findings no later than [**] following the applicable Decision Point;
5.1.9.    delegate any of its responsibilities to the DRC, MSC and JCC and oversee and review the DRC, MSC and JCC in the performance of their respective activities;
5.1.10.    subject to Sections 5.5.3 and 5.5.4, resolve disputes that may arise in the DRC, MSC and JCC; and
5.1.11.    perform such other functions as are set forth herein or in any Ancillary Agreement, or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
5.2.    Development and Regulatory Committee. Within [**] after the Effective Date, the Parties shall establish a joint development and regulatory committee (the “Development and Regulatory Committee” or “DRC”), which shall consist of three (3) representatives of each Party, each with the requisite experience and seniority to enable such person to make decisions on behalf of the applicable Party with respect to the issues falling within the jurisdiction of the DRC. From time to time, each Party may substitute one or more of its representatives to the DRC on written notice to the other Party. Sanofi shall select from its representatives the chairperson for the DRC, which chairperson may be changed from time to time, on written notice to Lexicon. The DRC shall:

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5.2.1.    periodically serve as a forum for discussing Development activities, including by reviewing the Development Plan and overseeing the conduct of the Development activities as provided in Section 3.1.2 and reviewing Development reports as provided in Section 3.1.7;
5.2.2.    review amendments to the Development Plan and provide recommendations to the JSC;
5.2.3.    facilitate the flow of information with respect to Development activities;
5.2.4.    oversee pharmacovigilance operations and discuss and recommend risk mitigation plans;
5.2.5.    recommend to the JSC, at each Decision Point in the Development Plan, whether Positive Results have been achieved;
5.2.6.    review reports related to Development Costs as provided in Section 7.6 and identify any concerns to the JSC; and
5.2.7.    perform such other functions as are set forth herein, in any Ancillary Agreement, or as the Parties may mutually agree in writing or as directed by the JSC, except where in conflict with any provision of this Agreement.
5.3.    Manufacturing and Supply Committee. Within [**] after the Effective Date, the Parties shall establish a joint manufacturing and supply committee (the “Manufacturing and Supply Committee” or “MSC”), which shall include appropriate representation of each Party (which such representation need not be equal), and each representative shall possess the requisite experience and seniority to enable such person to make decisions on behalf of the applicable Party with respect to the issues falling within the jurisdiction of the MSC. From time to time, each Party may substitute one or more of its representatives to the MSC on written notice to the other Party. Sanofi shall select from its representatives the chairperson for the MSC, which chairperson may be changed from time to time, on written notice to Lexicon. On the MSC, Lexicon shall have an advisory role only, and for clarity, any Dispute arising within the MSC shall not be resolved through the dispute resolution procedures in Section 13.5.2, but instead shall be decided by Sanofi’s MSC representatives. The MSC shall:
5.3.1.    periodically serve as a forum for discussing Manufacturing and supply of Licensed Products in the Territory hereunder or under any Supply Agreement;
5.3.2    oversee and ensure an efficient Technology Transfer to Sanofi or its designee from Lexicon, its Affiliates, Lexicon CMOs or other Third Parties, as set forth in Section 6.2 or any Technology Transfer Agreement;
5.3.3.    facilitate the flow of information with respect to Manufacturing activities; and
5.3.4.    perform such other functions as are set forth herein, or in any Ancillary Agreement, or if and as applicable, as the Parties may mutually agree in writing or as directed by the JSC, except where in conflict with any provision of this Agreement or any Ancillary Agreements.

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5.4.    Joint Commercialization Committee. Within [**] after the Effective Date, the Parties shall establish a joint commercialization committee (the “Joint Commercialization Committee” or “JCC”), which shall include appropriate representation of each Party (which such representation need not be equal), and each representative shall possess the requisite experience and seniority to enable such person to make decisions on behalf of the applicable Party with respect to the issues falling within the jurisdiction of the JCC. From time to time, each Party may substitute one or more of its representatives to the JCC on written notice to the other Party. Sanofi shall select from its representatives the chairperson for the JCC, which chairperson may be changed from time to time, on written notice to Lexicon. The JCC shall:
5.4.1.    periodically serve as a forum for discussing Commercialization of the Licensed Products in the Territory and Medical Affairs Activities in the Territory hereunder or the (Co-)Promotion Agreement, including the coordination of strategies for Commercialization activities and Medical Affairs Activities across the T1DM and T2DM indications;
5.4.2.    coordinate the activities of the Parties under the Commercialization Plans and oversee the implementation of the Commercialization Plans;
5.4.3.    review and discuss the Commercialization Plans and amendments thereto in accordance with Section 4.3;
5.4.4.    facilitate the flow of information with respect to Commercialization activities and Medical Affairs Activities with respect to the Licensed Product in the Territory;
5.4.5.    review reports related to Commercialization Costs and Medical Affairs Costs as provided in Section 7.7 and identify any concerns to the JSC; and
5.4.6.    perform such other functions as are set forth herein, or in any Ancillary Agreement, or if and as applicable, as the Parties may mutually agree in writing or as directed by the JSC, except where in conflict with any provision of this Agreement or any Ancillary Agreements.
5.5.     General Provisions Applicable to Committees.
5.5.1.    Meetings and Minutes. The JSC, DRC, MSC and JCC shall each meet at locations to be mutually agreed upon by the Parties from time to time or otherwise in accordance with Section 5.5.2, and at the frequencies provided for below, unless otherwise agreed to by the Parties:
(i)    the JSC shall meet at least [**] per Calendar Year;
(ii)    the DRC shall meet at least [**] per Calendar Year prior to[**], and at least [**] per Calendar Year thereafter;
(iii)    the MSC shall meet at least [**]per Calendar Year; and
(iv)    the JCC shall meet at least [**] per Calendar Year.
The chairperson of the respective committee shall be responsible for calling meetings on no less than [**] notice unless exigent circumstances require shorter notice. Each Party shall make all proposals for agenda items at least [**] in advance of the applicable meeting and shall provide all

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appropriate information with respect to such proposed items at least [**] in advance of the applicable meeting; provided that under exigent circumstances requiring input by the respective committee, a Party may provide its agenda items to the other Party within a shorter period of time in advance of the meeting or may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents to such later addition of such agenda items or the absence of a specific agenda for such meeting (which consent shall not be unreasonably withheld, conditioned or delayed). The chairperson of the respective committee shall prepare and circulate for review and approval of the Parties minutes of each meeting within [**] after the meeting. The Parties shall agree on the minutes of each meeting promptly, but in no event later than the next meeting of the respective committee.
5.5.2.    Procedural Rules. Each committee shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of each committee shall exist whenever there is present at a meeting at least one (1) representative appointed by each Party. Representatives of the Parties on each committee may attend a meeting either in person or by telephone, video conference or similar means in which each participant can hear what is said by and be heard by, the other participants. Representation by proxy shall be allowed. Subject to Section 5.5.3 (solely with respect to decisions of the JSC), each committee shall take action by unanimous decision of the representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance or by a written resolution signed by at least one (1) representative appointed by each Party. Alliance Managers or other employees or consultants of a Party who are not representatives of the Parties on the committee may attend meetings; provided, however, that such attendees (i) shall not vote or otherwise participate in the decision-making process of the committee and (ii) are bound by obligations of confidentiality and non-disclosure at least as protective of the other Party as those set forth in ARTICLE 9. If a committee (other than the JSC) cannot, or does not, reach a unanimous decision on an issue within [**], then the dispute shall be referred to the JSC for resolution and a special meeting of the JSC may be called for such purpose.
5.5.3.    Decision-Making. If the JSC does not reach a unanimous decision on an issue within the jurisdiction and authority of the JSC within [**], then either Party may refer such matter to the Senior Officers for resolution pursuant to Section 13.5.
5.5.4.    Limitations on Authority. Without limitation to the foregoing, the Parties hereby agree that the following matters are outside the jurisdiction and authority of the JSC and any other committee: (i) amendment, modification or waiver of compliance with this Agreement, (which may only be amended or modified as provided in Section 13.8 or compliance with which may only be waived as provided in Section 13.11), (ii) matters explicitly reserved to the consent, approval, agreement or other decision-making authority of either or both Parties in this Agreement and (iii) Disputes with respect to the validity (including any claim of inducement of this Agreement or any Ancillary Agreement by fraud or otherwise), application, breach, termination, interpretation or construction of this Agreement or the Ancillary Agreements (a “Legal Dispute”).
5.5.5.    Alliance Managers. Promptly after the Effective Date, by notice to the other Party, each Party shall appoint a person(s) who shall oversee contact between the Parties and facilitate the effective exchange of information between the Parties for all matters hereunder and shall have such other responsibilities as the Parties may agree in writing after the Effective Date, which person(s) may be replaced at any time by notice in writing to the other Party. The Alliance Managers shall work together to manage and facilitate the effective communication between the Parties under this Agreement,

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including the resolution (in accordance with the terms of this Agreement) of issues between the Parties that arise in connection with this Agreement.
5.5.6.    Discontinuation; Disbandment; Withdrawal; Annual Reports. The JSC, DRC, MSC or JCC, as applicable, shall continue to exist until the first to occur of: (i) the Parties’ mutually agreeing to disband such committee or as otherwise set forth in this Section 5.5.6; and (ii) Lexicon providing to Sanofi written notice of its intention to withdraw from such committee (provided that Lexicon shall not have the right to withdraw prior to [**]). Upon the occurrence of any of the foregoing, (a) the applicable committee shall disband, have no further responsibilities or authority under this Agreement and will be considered dissolved by the Parties and (b) any requirement of a Party to provide Information and Inventions or other materials to such committee shall be deemed a requirement to provide such Information and Inventions or other materials to the other Party, or the JSC (in the case that the DRC, MSC or JCC is disbanded and the JSC is still in existence) and, solely in the case where the JSC has been disbanded, Sanofi shall, subject to Sections 5.5.4 and 13.5, have the right to solely decide, without consultation with Lexicon, all matters that are subject to the review or approval by the JSC hereunder other than determinations as to whether or not Positive Results have been achieved as set forth in Section 3.1.3 and Section 5.1.8, which determinations pursuant to Section 3.1.3 and Section 5.1.8 shall be resolved by binding arbitration pursuant to Section 13.5.2 if not otherwise agreed by the Parties. The MSC, DRC and JCC shall each continue to exist only for so long as the JSC is in existence; provided, however, that without limiting the foregoing, the DRC, MSC or JCC may be disbanded or discontinued at any time pursuant to a written unanimous decision of the JSC or as set forth in clauses (i) and (ii) of this Section 5.5.6. Upon disbandment of the DRC, MSC or JCC, or at any time in the JSC’s discretion, the JSC may assume from the DRC, MSC or JCC any and all of those committees respective responsibilities, and with respect to any MSC matters, any Dispute arising within the JSC shall not be resolved through the dispute resolution procedures in Section 13.5.2, but instead shall be decided by Sanofi’s JSC representatives. If not already disbanded, then the MSC shall be disbanded upon the completion of both the Technology Transfer pursuant to Section 6.2 and the full assumption of Manufacturing of Licensed Products by Sanofi.
ARTICLE 6
SUPPLY

6.1.    Supply of Licensed Products.
6.1.1.    Clinical Supply. In connection with the Technology Transfer, Lexicon shall transfer to Sanofi any usable inventory of Licensed Compound or Licensed Product, subject to Lexicon’s retention of reasonable requirements of such Licensed Compound or Licensed Product for its T1DM Development activities no later than [**] (or such other date as is agreed by the Parties), and Lexicon’s Manufacturing Cost paid to Lexicon CMOs for such transferred quantities of inventory shall be treated as Development Costs and borne by the Parties in accordance with Section 7.6. Prior to the completion of the Technology Transfer in accordance with Section 6.2, Lexicon shall, to the extent requested by Sanofi and as mutually agreed by the Parties, supply clinical quantities of the Licensed Products and placebo for use by Sanofi in the Development of Licensed Products for T2DM in accordance with the Development Plan, and Lexicon’s Manufacturing Cost incurred in connection therewith shall be treated as Development Costs. After the Technology Transfer, Sanofi shall supply clinical quantities of the Licensed Products and placebo reasonably required by Lexicon for Lexicon’s use in the Development of Licensed Products for T1DM in accordance with the Development Plan and for its own use in the Development of Licensed Products. Lexicon shall Manufacture (or have Manufactured) all such Licensed Product in accordance

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with Applicable Law and the applicable specifications therefor, including, to the extent required by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound or Licensed Product within reasonable timelines to be mutually agreed by the Parties in writing, but nothing in this Section 6.1.1 shall limit Lexicon’s liability for Third Party Claims under ARTICLE 11. At either Party’s option, Lexicon and Sanofi shall enter into a clinical supply agreement and a reasonable and customary Quality Agreement that shall set forth the terms and conditions upon which Lexicon and any of its Affiliates will conduct their quality activities in connection with such supply, including (i) a right of Sanofi to audit Lexicon and the Lexicon CMOs, (ii) coordination regarding inspections by Regulatory Authorities and (iii) the exchange of information between the Parties regarding the foregoing and quality issues in general. Such agreements shall be negotiated and agreed by the Parties in good faith.
6.1.2.    Validation Campaign and Commercial Supply. Except as otherwise set forth in this Section 6.1, Sanofi shall have the sole right and responsibility, at its sole discretion and at its expense, to Manufacture (or have Manufactured) and supply the Licensed Products (including the Licensed Compounds contained therein) for Exploitation in or for the Territory by Sanofi and its Affiliates and its or their Sublicensees.
6.2.    Manufacturing Technology Transfer. Without limiting the generality of the obligations in Section 2.4, Lexicon shall commence, as and when reasonably requested by Sanofi, the transfer to Sanofi or its designee (which designee may be an Affiliate, Sublicensee, Lexicon CMO or other Third Party manufacturer) of the Lexicon Know-How necessary or useful to perform the then-current process for the Manufacture of the Licensed Compound and Licensed Products, as well as any improvements or enhancements to such processes via a cGMP-compliant technology transfer (the “Manufacturing Process”) and provide such support as may be necessary or reasonably useful to Sanofi or its designee to use and practice the Manufacturing Process, including by (i) if permitted under the terms and conditions thereof, assigning to Sanofi, at its request, any agreements (including any open purchase orders) with Lexicon CMOs that are necessary or useful to perform Manufacturing activities related to the Licensed Compound or the Licensed Products or (ii) if such assignment is prohibited by the terms thereof or Applicable Law and if requested by Sanofi, by reasonably assisting Sanofi or its designee to enter into agreements with such Lexicon CMOs (the “Technology Transfer”). The Technology Transfer shall be conducted in accordance with reasonable timelines as mutually agreed by the Parties with the goal of completing the Technology Transfer within a reasonable time. Lexicon shall or shall cause its CMOs to allocate the necessary resources to ensure the Technology Transfer occurs in a timely and efficient manner in accordance with such deadlines. All costs and expenses of Lexicon’s internal personnel incurred by Lexicon pursuant to such Technology Transfer or any subsequent technology transfer, as provided in Section 6.3, shall be the responsibility of Lexicon, and all out-of-pocket expenses paid to Lexicon CMOs shall be the responsibility of Sanofi.
6.3.    Subsequent Manufacturing Technology Transfer. Without limiting the foregoing, in the event that Lexicon or any of its Affiliates generates any material additional Lexicon Know-How relating to, or that is otherwise necessary or useful for, the Manufacture of the Licensed Compound or a Licensed Product during the Term, Lexicon shall promptly disclose such Lexicon Know-

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How to Sanofi and shall, at Sanofi’s request, perform technology transfer with respect to such Lexicon Know-How in the same manner as provided in Section 6.2.
6.4.    Technology Transfer Agreement. At Sanofi’s request, the Parties shall enter into a mutually acceptable Technology Transfer agreement consistent with Sections 6.2 and 6.3, which details the timeline and responsibilities of both Parties in connection with the Technology Transfer and any subsequent technology transfers from Lexicon to Sanofi during the Term (the “Technology Transfer Agreement”); provided, however, that the failure to enter into the Technology Transfer Agreement shall not relieve Lexicon of its obligations to conduct the Technology Transfers and disclosures contemplated by Sections 6.2 and 6.3.
ARTICLE 7
PAYMENTS AND RECORDS
1.
7.1.    Upfront Payment. In partial consideration of the rights granted by Lexicon to Sanofi hereunder and subject to the terms and conditions of this Agreement, no later than [**] after the later of (i) the Effective Date and (ii) receipt of an invoice therefor from Lexicon, Sanofi shall pay Lexicon a noncreditable upfront payment amount of three hundred million Dollars ($300,000,000). For clarity, Sanofi shall not pay such amount prior to receipt of such an invoice and the prescribed forms relating to tax withholding set forth in Section 7.11.1.
7.2    Milestones.
7.2.1.    Development and Regulatory Milestone Payments. In partial consideration of the rights granted by Lexicon to Sanofi hereunder and subject to the terms and conditions of this Agreement, Sanofi shall pay to Lexicon a milestone payment, after the achievement of each of the following milestones in accordance with this Section 7.2.1, as follows:
(a)    Development Milestones.
(i)    [**];
(ii)    [**]; provided that, if [**], this milestone payment shall become payable concurrently with [**]; and
(iii)    [**].
(b)    Regulatory Milestones.
(i)    [**]; and
(ii)    [**];
(iii)    [**]; and
(iv)    [**]
Sanofi shall provide prompt written notice to Lexicon of the achievement of each applicable milestone. Upon receipt of such notice, Lexicon shall provide an invoice to Sanofi, and payment shall be due within [**] after receipt by Sanofi of such invoice. Each milestone payment in this Section 7.2.1 shall be payable

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only upon the first achievement of such milestone and no amounts shall be due for subsequent or repeated achievements of such milestone, whether for the same or a different Licensed Product.
7.2.2.    Sales Milestones. In partial consideration of the license rights granted by Lexicon to Sanofi hereunder and subject to the terms and conditions of this Agreement, Sanofi shall pay to Lexicon milestone payments, after the achievement of each of the following milestones in accordance with this Section 7.2.2; provided that if more than one such milestone is first achieved in the same Calendar Year, there shall be [**] and, in such event, the payment for [**] and the payment(s) for [**].
(a)    In the event that the aggregate of all Net Sales of all Licensed Products made by Sanofi or any of its Affiliates or its or their Sublicensees in [**] exceeds [**] for such [**], Sanofi shall pay to Lexicon [**].
(b)    In the event that the aggregate of all Net Sales of all Licensed Products made by Sanofi or any of its Affiliates or its or their Sublicensees in [**] exceeds [**] for such [**], Sanofi shall pay to Lexicon [**].
(c)    In the event that the aggregate of all Net Sales of all Licensed Products made by Sanofi or any of its Affiliates or its or their Sublicensees in [**] exceeds [**] for such [**], Sanofi shall pay to Lexicon [**].
(d)    In the event that the aggregate of all Net Sales of all Licensed Products made by Sanofi or any of its Affiliates or its or their Sublicensees in [**] exceeds [**] for such [**], Sanofi shall pay to Lexicon [**].
(e)    In the event that the aggregate of all Net Sales of all Licensed Products made by Sanofi or any of its Affiliates or its or their Sublicensees in [**] exceeds [**] for such [**], Sanofi shall pay to Lexicon [**].
(f)    In the event that the aggregate of all Net Sales of all Licensed Products made by Sanofi or any of its Affiliates or its or their Sublicensees in [**] exceeds [**] for such [**], Sanofi shall pay to Lexicon [**].
Within [**] after the end of each Calendar Quarter and in connection with the royalty reports provided to Lexicon pursuant to Section 7.5, Sanofi shall provide written notice to Lexicon of each milestone set forth in this Section 7.2.2 that was achieved in such Calendar Quarter. Upon receipt of such notice, Lexicon shall provide an invoice to Sanofi, and payment shall be due within [**] after receipt by Sanofi of such invoice; provided that, if a higher milestone set forth in this Section 7.2.2 is first achieved in a subsequent Calendar Quarter during the same [**], Lexicon shall provide an invoice to Sanofi for, and Sanofi shall pay, [**], such that [**] under this Section 7.2.2 for such [**] equals [**]. Each milestone payment in this Section 7.2.2 shall be payable only once and no amounts shall be due for subsequent or repeated achievements of the applicable milestone in subsequent [**].
7.2.3.    Milestones and Termination. If either Party provides a notice of termination of this Agreement pursuant to Section 12.3 (or termination of country(ies) or region(s) or any Licensed Products with respect to which a milestone is due), then in no event shall Lexicon accrue any rights to, and Sanofi shall have no obligation to make, any milestone payment under Section 7.2.1 with respect to such Terminated Territory or Terminated Product from and after the date of such notice (even if such milestone was achieved before the date of such notice); provided, that, if this Agreement is not

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actually terminated following such notice, then any milestone payments associated with the achievement of a milestone with respect to such country or jurisdiction after such date of notice shall be due within [**] after the date on which it was determined by the Parties in writing that this Agreement would not terminate.
7.3.    Royalties.
7.3.1.    Royalty Rates. As additional consideration for the rights granted to Sanofi hereunder and subject to the terms and conditions of this Agreement, during the applicable Royalty Term in each country of the Territory as specified below, Sanofi shall pay to Lexicon a royalty on Net Sales to Third Parties (including Distributors) of each Licensed Product in such region of the Territory during each Calendar Year within [**] after the end of each Calendar Quarter, subject to this Section 7.3, at the following rates:
(i)    For T1DM in the United States:
(a)    for that portion of aggregate T1DM Net Sales in the United States during a Calendar Year less than or equal to [**], a royalty rate of [**];
(b)    for that portion of aggregate T1DM Net Sales in the United States during a Calendar Year greater than [**], but less than or equal to [**], a royalty rate of [**]; and
(c)    for that portion of aggregate T1DM Net Sales in the United States during a Calendar Year greater than [**], but less than or equal to [**], a royalty rate of [**]; and
(d)    for that portion of aggregate T1DM Net Sales in the United States during a Calendar Year greater than [**], a royalty rate of forty percent (40%).
Notwithstanding the foregoing, if Lexicon does not exercise the (Co-)Promotion Right in accordance with Section 4.8, enter into the (Co-)Promotion Agreement or terminates the (Co-)Promotion Agreement for convenience, the royalty rate under clause (a) of this Section 7.3.1(i) shall be [**] instead of [**].
(ii)    For T2DM in the United States:
(a)    for that portion of aggregate T2DM Net Sales in the United States during a Calendar Year less than or equal to [**], a royalty rate of [**];
(b)    for that portion of aggregate T2DM Net Sales in the United States during a Calendar Year greater than [**], but less than or equal to [**], a royalty rate of [**];
(c)    for that portion of aggregate T2DM Net Sales in the United States during a Calendar Year greater than [**], but less than or equal to [**], a royalty rate of [**]; and
(d)    for that portion of aggregate T2DM Net Sales in the United States during a Calendar Year greater than [**], a royalty rate of [**].
(iii)    For the European Union:
(a)    for that portion of aggregate Net Sales of all Licensed Products in the European Union during a Calendar Year less than or equal to [**], a royalty rate of [**];

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(b)    for that portion of aggregate Net Sales of all Licensed Products in the European Union during a Calendar Year greater than [**], but less than or equal to [**], a royalty rate of [**]; and
(c)    for that portion of aggregate Net Sales of all Licensed Products in the European Union during a Calendar Year greater than [**], a royalty rate of [**].
(iv)    For all countries in the Territory, other than the United States and those countries in the European Union (such countries, “ROW”), the royalty rate shall be [**] of aggregate Net Sales of all Licensed Products in ROW.
With respect to each Licensed Product in each country in the Territory, from and after the expiration of the Royalty Term for such Licensed Product in such country, Net Sales of such Licensed Product in such country shall be excluded for purposes of calculating the Net Sales thresholds and ceilings set forth in this Section 7.3.1.
7.3.2.    Royalty Term. Sanofi shall have no obligation to pay any royalty with respect to Net Sales of any Licensed Product in any country after the Royalty Term for such Licensed Product in such country has expired.
7.3.3.    Reductions. Notwithstanding the foregoing, in the event that:
(i)    in any country in the Territory during the Royalty Term for a Licensed Product, one or more Generic Products of a Licensed Product is launched in such country, and Net Sales of such Licensed Product in such country decline by the percentages described below relative to the average Net Sales of such Licensed Product in such country for the [**] immediately preceding the Calendar Quarter in which the Generic Product is launched in such country (the “Pre-Generic Launch Net Sales”), the royalty rates provided in Section 7.3.1 shall be reduced in such country by the applicable percentage described below for each Calendar Quarter ending after the Generic Product was launched in which such Net Sales remain below the applicable percentage of the Pre-Generic Launch Net Sales. For clarity, the foregoing sentence shall not preclude the applicability of this Section 7.3.3(i) to future Calendar Quarters if such Generic Product or any other Generic Product is re-launched or launched, as applicable, in such country and Net Sales again fall below the applicable percentage of the Pre-Generic Launch Net Sales. For a decline of:
(a)    greater than or equal to [**], but less than [**], of Net Sales of the applicable Licensed Product in such country, a royalty rate reduction of [**]; or
(b)    greater than or equal to [**] of Net Sales of the applicable Licensed Product in such country, a royalty rate reduction of [**].
(ii)    If Sanofi enters into an agreement with a Third Party in order to obtain a license or other right under a Third Party Patent that is reasonably necessary to avoid infringement of such Third Party Patent by the use, offer for sale, sale or importation of a Licensed Product (or the Licensed Compound contained therein) in a country pursuant to Section 8.8, Sanofi shall be entitled to deduct from any [**] royalties (under this Section 7.3) payable hereunder with respect to such Licensed Product in such country [**] of all upfront payments, milestone payments, royalties, and other amounts paid to such Third Party in respect of such agreement, in each case, to the extent reasonably allocable to such Third Party Right (“Third Party Payments”); provided that, Sanofi may not include in Third Party Payments

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any amounts paid to Third Party suppliers or contract manufacturers of Licensed Products, Licensed Compounds or raw materials therefor.
(iii)    If a court or a governmental agency of competent jurisdiction requires Sanofi or any of its Affiliates or its or their Sublicensees to grant a compulsory license to a Third Party permitting such Third Party to make and sell a Licensed Product in a country in the Territory, the royalties otherwise due to Lexicon pursuant to this Section 7.3 for Net Sales by compulsory licensees shall, in lieu of the royalties that would otherwise apply, be the lesser of [**] of the amount received by Sanofi from such licensee and the applicable royalties that would otherwise be payable hereunder, and the Licensed Products sold by such Third Party in such country shall be deemed to be Generic Products for purposes of Section 7.3.3(i).
(iv)    As to royalties payable on Net Sales in [**], during any period within the applicable Royalty Term when there is no Lexicon Patent or Joint Patent in such country that contains a Valid Claim that Covers the applicable Licensed Product or its Manufacture, use, offer for sale, sale or importation in such country and the Regulatory Exclusivity Period has expired with respect to the applicable Licensed Product in such country, the otherwise applicable royalty rate percentage with respect to such Licensed Product in such country shall be reduced by [**].
(v)    On a country-by-country basis with respect to each country in [**] during each period in which there is a [**], Sanofi shall be entitled to deduct from the royalty rate payable on Net Sales in such country [**] of the [**]; provided that such deduction shall not exceed [**]. The [**] is, with respect to a given period and country outside [**], the percentage equal to (x) [**], divided by (y) [**] in such country for such period. The [**] is, with respect to a given period, the percentage equal to [**]. For example, if the [**] for a given period and country equals [**] and the royalty rate for a given country would without application of this clause (v) equal [**], the royalty rate for such country would equal [**]. For clarity, [**] are not required to be calculated on a country-by-country basis, but may be calculated using a standard cost basis across multiple countries in accordance with Sanofi’s general internal practices.
Any reductions set forth in this Section 7.3.3 shall be applied to the royalty rate payable to Lexicon in the following order: clause (i) (in which case no further reductions shall be applied under the subsequent clauses of this Section 7.3.3), clause (ii), clause (iii), clause (iv) and clause (v).
7.3.4.    Maximum Amount of Royalty Reduction. In no event shall the royalty rate payable to Lexicon under this Section 7.3 be reduced below [**] of the royalty rates set forth in Section 7.3.1 in any Calendar Year as a result of the reductions set forth in Sections 7.3.3(ii) and 7.3.3(iv), collectively.
7.4.    Estimated Sales Levels. Lexicon acknowledges and agrees that the sales levels set forth in Section 7.2.2 and Section 7.3 shall not be construed as representing an estimate or projection of anticipated sales of the Licensed Products or implying any level of diligence or Commercially Reasonable Efforts, in the Territory and that the sales levels set forth in those Sections are merely intended to define Sanofi’s royalty and other payment obligations, as applicable, in the event such sales levels are achieved.
7.5.    Royalty Payments and Reports. Sanofi shall calculate all amounts payable to Lexicon pursuant to Section 7.2.2 and Section 7.3 at the end of each Calendar Quarter, where Net Sales shall be converted to Dollars, in accordance with Section 7.9, and Sanofi shall provide written notice of

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such amounts to Lexicon within [**] after the end of each Calendar Quarter, which report shall include a statement of (i) Net Sales, and (ii) [**] Invoiced Sales, and the applicable deductions used to convert Invoiced Sales to Net Sales, of Licensed Product in each country during the applicable Calendar Quarter. Each report shall be accompanied by the applicable payment of royalties due to Lexicon for such Calendar Quarter pursuant to Section 7.3.
7.6.    Development Costs.
7.6.1.    Subject to this Section 7.6, each Party shall be responsible for and shall reimburse the other Party, as applicable, for Development Costs reasonably incurred after the Effective Date in connection with the performance of Development activities in accordance with the cost-sharing principles set forth below and the Development Plan, unless otherwise agreed by the Parties and set forth in the Development Plan. To the extent FTE efforts are included in Development Costs and reimbursable by the other Party pursuant hereto, each Party shall record and account for such FTE efforts with respect to each Licensed Product, and each Party shall report such FTE efforts to the DRC on a quarterly basis. Each Party shall calculate and maintain records of FTE effort incurred by it consistent with past practice and in the same manner as used for other products developed by such Party, unless agreed by the Parties in writing. The Parties shall share Development Costs according to the following principles:
(i)    Sanofi shall be responsible for [**], and Lexicon shall be responsible for [**] of Development Costs in connection with T2DM Development under and in accordance with the Development Plan, which Development Costs are incurred prior to the date that is the third (3rd) anniversary of the Effective Date, (the “Cost Sharing Trigger Point”); provided Development Costs corresponding to Development activities for T2DM Development which were, due to any action or inaction by Lexicon, incurred on and after instead of prior to the Cost-Sharing Trigger Point shall be allocated between the Parties in accordance with the allocation for Development Costs for T2DM Development in effect prior to the Cost-Sharing Trigger Point; provided further, that Lexicon’s share of Development Costs under this Section 7.6.1(i) shall not exceed one hundred million Dollars ($100,000,000) in the aggregate, and Sanofi shall be responsible for any Development Costs covered by this clause (i) in excess of such amount;
(ii)    Sanofi shall be responsible for one hundred percent (100%) of Development Costs in connection with T2DM Development under and in accordance with the Development Plan, which Development Costs are incurred after the Cost Sharing Trigger Point under the Development Plan;
(iii)    Sanofi shall be responsible for [**] of Development Costs incurred under and in accordance with the Development Plan that are not specifically attributable to T2DM Development or T1DM Development;
(iv)    Lexicon shall be responsible for one hundred percent (100%) of Development Costs incurred under and in accordance with the Development Plan in connection with T1DM Development (where for clarity, Development Costs incurred for any activity specified in the Development Plan as T1DM Development shall be borne by Lexicon); and
(v)    For clarity, any payments due under the T1DM Funding Agreements shall not be included in Development Costs or Commercialization Costs and shall be solely borne by Lexicon.
provided, that, in each case of clauses (i) through (iv) above, a Party shall not be responsible for Development Costs incurred by either Party due to a breach of this Agreement by, or the negligence or

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willful misconduct of, the other Party or any of its Affiliates (the “At-fault Party”), including, for example, delay in shipping a bulk batch of Licensed Compound or Licensed Product, which such Development Costs shall be borne by the At-fault Party.
7.6.2.    Any Development Costs in excess of the Development Costs for a given activity budgeted in the Development Plan shall be borne by the incurring Party and shall be excluded from Development Costs hereunder unless such excess was due to breach of this Agreement by, or the negligence or willful misconduct of, the other Party or any of its Affiliates, in which case, such excess Development Costs shall be borne by the At-fault Party.
7.6.3.    For so long as Development Costs are reimbursable by a Party pursuant hereto, the other Party shall report to the reimbursing Party, within [**] after the end of each Calendar Quarter (and within [**] after receipt of each such report, the Parties shall reimburse one another, as needed, for) its respective Development Costs in order to achieve the cost sharing allocation contemplated by this Section 7.6. Each such report shall (a) allocate the Development Costs to the extent possible to a specific Development activity under the Development Plan, (b) specify in reasonable detail all amounts included in Development Costs during such Calendar Quarter (broken down by activity), (c) if requested by the other Party, include copies of any invoices or other supporting documentation for any payments to a Third Party that individually exceed [**] (or such other amount approved by the JSC or DRC, as applicable) and (d) enable the other Party to compare the reported costs against the Development Plan on both a quarterly basis and a cumulative basis for each activity. The Parties shall seek to resolve any questions related to such reports within [**] following receipt by the other Party of the reporting Party’s report hereunder.
7.7.    Commercialization Costs and Medical Affairs Costs. Subject to this Section 7.7, each Party shall be responsible for and shall reimburse the other Party, as applicable, for Commercialization Costs and Medical Affairs Costs reasonably incurred after the Effective Date in connection with the performance of Commercialization activities in accordance with the cost-sharing principles set forth below and the Commercialization Plan, unless otherwise agreed by the Parties and set forth in the Commercialization Plan. To the extent FTE efforts are included in Commercialization Costs and reimbursable by the other Party pursuant hereto, each Party shall record and account for such FTE efforts with respect to each Licensed Product, and each Party shall report such FTE efforts to the JCC on a quarterly basis. Each Party shall calculate and maintain records of FTE effort incurred by it consistent with past practice and in the same manner as used for other products developed by such Party, unless agreed by the Parties in writing. The Parties shall share Commercialization Costs and Medical Affairs Costs according to the following principles:
7.7.1.    If Lexicon exercises the (Co-)Promotion Right, then for each Calendar Year during the Term, Lexicon shall be responsible for forty percent (40%) of the Commercialization Costs and Medical Affairs Costs, in each case incurred in accordance with the T1DM Commercialization Plan during such Calendar Year with respect to the Licensed Product for T1DM in the (Co-)Promotion Territory, but in no event more than the Lexicon Maximum Amount for such Calendar Year. Sanofi shall be responsible for the remainder of the Commercialization Costs and Medical Affairs Costs, whether incurred by Lexicon or Sanofi, except as otherwise agreed by the Parties in the (Co-)Promotion Agreement; except that in the event that pursuant to the immediately preceding sentence, Lexicon bears less than forty percent (40%) of such Commercialization Costs and Medical Affairs Costs due to the application of the Lexicon Maximum Amount for any Calendar Year, then the difference between what Lexicon would have borne in the absence of the application of the Lexicon Maximum Amount and the amount borne by Lexicon for the

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applicable Calendar Year shall be considered the “Carry-Over Amount”). Then, in the event that there is a Calendar Year in which Lexicon bears less than the Lexicon Maximum Amount, Sanofi may also charge Lexicon under this Section 7.7.1 for any Carry-Over Amount, up to the point at which Lexicon has paid, in Commercialization Costs, Medical Affairs Costs and Carry-Over Amount in aggregate under this Section 7.7.1, the Lexicon Maximum Amount for that Calendar Year, until any and all Carry-Over Amounts have been exhausted. If Lexicon does not exercise the (Co-)Promotion Right, then Sanofi shall be responsible for one hundred percent (100%) of Commercialization Costs and Medical Affairs Costs incurred after the Effective Date with respect to the Licensed Product for T1DM. Notwithstanding the foregoing in this Section 7.7.1, a Party shall not be responsible for Commercialization Costs or Medical Affairs Costs incurred by either Party due to a breach of this Agreement by, or the negligence or willful misconduct of, the At-fault Party (which in the case in which Lexicon is the At-fault Party shall not count towards the Lexicon Maximum Amount).
7.7.2.    Sanofi shall be responsible for one hundred percent (100%) of Commercialization Costs and Medical Affairs Costs incurred after the Effective Date with respect to the Licensed Product for T2DM. Notwithstanding the foregoing in this Section 7.7.2, a Party shall not be responsible for Commercialization Costs or Medical Affairs Costs incurred by either Party due to a breach of this Agreement by, or the negligence or willful misconduct of, the At-fault Party.
7.7.3.    Any Commercialization Costs or Medical Affairs Costs in excess of the Commercialization Costs or Medical Affairs Costs, as applicable, for a given activity budgeted in the Commercialization Plan shall be borne by the incurring Party and shall be excluded from Commercialization Costs or Medical Affairs Costs, as applicable, hereunder unless such excess was due to breach of this Agreement by, or the negligence or willful misconduct of, the other Party or any of its Affiliates, in which case, such excess Commercialization Costs or Medical Affairs Costs, as applicable, shall be borne by the At-fault Party.
7.7.4.    With respect to any Commercialization Costs or Medical Affairs Costs that are reimbursable by a Party pursuant hereto, the other Party shall report to the reimbursing Party, within [**] after the end of each Calendar Quarter (and within [**] after receipt of each such report, the Parties shall reimburse one another, as needed, for) its respective shared Commercialization Costs and Medical Affairs Costs in order to achieve the cost sharing allocation of such shared costs contemplated by this Section 7.7. Each such report with respect to such shared costs shall (a) allocate the Commercialization Costs and Medical Affairs Costs to the extent possible to a specific Commercialization activity or Medical Affairs Activity, as applicable, under the Commercialization Plan, (b) specify in reasonable detail all amounts included in Commercialization Costs and Medical Affairs Costs during such Calendar Quarter (broken down by activity), (c) if requested by the other Party, include copies of any invoices or other supporting documentation for any payments to a Third Party that individually exceed [**] (or such other amount approved by the JSC or JCC, as applicable) and (d) enable the other Party to compare the reported costs against the Commercialization Plan on both a quarterly basis and a cumulative basis for each activity. The Parties shall seek to resolve any questions related to such reports within [**] following receipt by the other Party of the reporting Party’s report hereunder.
7.8.    Calculation of T1DM Net Sales. The Parties shall agree upon a methodology for determining quarterly T1DM Net Sales based on data from a mutually agreed Third Party data source, such as IMS Health and allocation of costs as appropriate. If the Parties are unable to reach agreement on such methodology or Third Party data source and such allocation as appropriate, the Parties shall submit such matter for resolution pursuant to Section 13.5. T1DM Net Sales shall be determined using the

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methodology and data established pursuant to this Section 7.8, based on the Net Sales in the United States for the applicable Calendar Quarter pursuant to Section 7.5, subject to Lexicon’s audit rights under Section 7.14.
7.9.    Mode of Payment. All payments to either Party under this Agreement shall be made by deposit of Dollars in the requisite amount to such bank account as the receiving Party may from time to time designate by notice to the paying Party. For the purpose of calculating any sums due under, or otherwise reimbursable pursuant to, this Agreement (including the calculation of Net Sales expressed in currencies other than Dollars), a Party shall convert any amount expressed in a foreign currency into Dollar equivalents using its, its Affiliate’s or Sublicensee’s standard conversion methodology consistent with applicable Accounting Standards.
7.10.    Failure to Achieve Positive Results. If Positive Results are not achieved with respect to a given Decision Point, as determined in accordance with Section 3.1.3,and if elected by Sanofi, then the Parties shall promptly meet to negotiate in good faith to alter the financial terms provided for under this ARTICLE 7 to address such failure to achieve Positive Results, and if an agreement is reached among the Parties, the Agreement shall be amended to give effect to such agreement. Otherwise, for clarity, Sanofi shall have the right to terminate for a Positive Results Failure pursuant to Section 12.3.2(i).
7.11.    Taxes.
7.11.1.    General. The milestones, royalties and other amounts payable by Sanofi to Lexicon pursuant to this Agreement (each, a “Payment”) shall be paid free and clear of any and all taxes, except for any withholding taxes required by Applicable Law. Notwithstanding the foregoing or anything to the contrary in this Section 7.11.1, Sanofi shall not withhold any tax from the Payments made to Lexicon for so long as Lexicon remains a tax resident of the United States and the applicable tax treaty between the United States and France provides for a withholding rate of zero on the applicable Payment, provided that Lexicon shall provide the prescribed forms necessary to reduce the applicable rate of withholding or to relieve Sanofi of its obligation to withhold such tax pursuant to such applicable tax treaty between the United States and France with any invoice supporting a Payment request hereunder. Except as provided in this Section 7.11.1, Lexicon shall be solely responsible for paying any and all taxes (other than withholding taxes deducted from Payments and remitted by Sanofi as described above) levied on account of, or measured in whole or in part by reference to, any Payments it receives. Sanofi and Lexicon shall cooperate with one another to communicate in advance regarding the satisfaction of any requirements necessary to reduce the applicable rate of withholding or to relieve Sanofi of its obligation to withhold any such tax. If, in accordance with the foregoing, Sanofi withholds any amount, it shall pay to Lexicon the balance when due, make timely payment to the proper taxing authority of the withheld amount and send to Lexicon proof of such payment within [**] following such payment.
7.11.2.    Value Added Tax. Notwithstanding anything contained in Section 7.11.1, this Section 7.11.2 shall apply with respect to value added tax (“VAT”). All Payments are exclusive of VAT. If any VAT is chargeable in respect of any Payments, Sanofi shall pay VAT at the applicable rate in respect of any such Payments following the receipt of a VAT invoice in the appropriate form issued by Lexicon in respect of those Payments, such VAT to be payable on the later of the due date of the payment of the Payments to which such VAT relates and [**] after the receipt by Sanofi of the applicable invoice relating to that VAT payment.

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7.12.    Interest on Late Payments. If any payment due to either Party under this Agreement is not paid when due, then such paying Party shall pay interest thereon (before and after any judgment) at an annual rate (but with interest accruing on a daily basis) of [**] basis points above the London Interbank Offered Rate for deposits in United States Dollars having a maturity of one (1) month published by the British Bankers’ Association, as adjusted from time to time on the first London business day of each month, such interest to run from the date on which payment of such sum became due until payment thereof in full together with such interest.
7.13.    Financial Records. Each Party shall, and shall cause its Affiliates and its and their (sub)licensees (including distributors deemed to be Sublicensees under the definition of Net Sales) to, keep complete and accurate financial books and records pertaining to (i) any Development Costs, Commercialization Costs and Medical Affairs Costs, in each case that are reimbursable (in whole or in part) by the other Party hereunder (ii) only with respect to Sanofi, Net Sales of Licensed Products, and (iii) only with respect to Lexicon, ROFN1 Development Costs and ROFN2 Development Costs, in each case ((i), (ii) and (iii)), to the extent required to calculate and verify all amounts payable hereunder. Each Party shall, and shall cause its Affiliates and its and their (sub)licensees (including distributors deemed to be Sublicensees under the definition of Net Sales) to, retain such books and records until the later of (x) [**] after the end of the period to which such books and records pertain and (y) the expiration of the applicable tax statute of limitations (or any extensions thereof) or for such longer period as may be required by Applicable Law.
7.14.    Audit Procedures.
7.14.1.    At the request of the other Party, each Party shall, and shall cause its Affiliates and its and their Sublicensees (including distributors deemed to be Sublicensees under the definition of Net Sales) to, permit an independent auditor designated by the other Party and reasonably acceptable to the audited Party, at reasonable times and upon reasonable notice, to audit the books and records maintained pursuant to Section 7.13 to ensure the accuracy of all reports and payments made hereunder.
7.14.2    Such examinations may not (i) be conducted for any Calendar Quarter more than [**] after the end of such Calendar Quarter, (ii) be conducted more than [**] in any [**] (unless a previous audit during such [**] revealed an underpayment (or with respect to any reimbursement, an overpayment) with respect to such period) or (iii) be repeated for any Calendar Quarter; provided that Sanofi shall be permitted to audit Lexicon after Sanofi’s exercise of the applicable right of first negotiation pursuant to Section 2.7.1 or Section 2.7.2, as applicable, once (a) with respect to the ROFN1 Development Costs, such audit to be conducted after PoC Successful Completion, or (b) with respect to the ROFN2 Development Costs, such audit to be conducted after P3 Successful Completion.
7.14.3.    Upon completion of the audit, the auditor shall provide a report to both Parties, which report shall be limited to a description of any failure to comply with the terms of this Agreement and the amount of the financial discrepancy (whether relating to the royalty calculations, calculations of milestones under Section 7.2.2, Development Cost reporting or Net Sales calculations).
7.14.4.    The cost of this audit shall be borne by the auditing Party, unless the audit reveals an underpayment by or over-reporting of applicable costs or an under-reporting of applicable revenues by the audited Party, in either case of more than [**] from the reported amounts for the period under audit, in which case the audited Party shall bear the cost of the audit. Subject to the dispute

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resolution provisions set forth in Section 13.5, if such audit concludes that (a) Sanofi underpaid royalties or sales milestones, then Sanofi shall pay the additional amounts due, with interest from the date originally due as provided in Section 7.12, (b) Sanofi overpaid royalties or sales milestones, then Lexicon shall refund such amounts, or (c) the audited Party over-reported Development Costs, then the audited Party shall make a reconciling payment to the other Party, as required to achieve the allocation of Development Costs set forth in Section 7.6, with interest from the date originally due as provided in Section 7.12. In each case of a payment due under this Section 7.14, such payment shall be made within [**] after the date on which the audit report is delivered to the Parties.
7.14.5.    The receiving Party shall treat all information subject to review under this ARTICLE 7 in accordance with the confidentiality provisions of ARTICLE 9 and the Parties shall cause the auditor to enter into a reasonably acceptable confidentiality agreement with the audited Party obligating such firm to retain all such financial information in confidence pursuant to such confidentiality agreement.
7.15.    Right to Offset. Each Party shall have the right to offset any amount owed by the other Party to such first Party under or in connection with this Agreement, including pursuant to ARTICLE 11 or in connection with any breach, against any payments owed by such first Party to such other Party under this Agreement; provided that no such offset shall be applied based on breach damages unless and until such damages have been reduced to a final arbitration award pursuant to Section 13.5 or such other Party has agreed to such damages through settlement. Such offsets shall be in addition to any other rights or remedies available under this Agreement and Applicable Law.

ARTICLE 8
INTELLECTUAL PROPERTY

8.1    Ownership of Intellectual Property.
8.1.1.    Ownership of Technology. Subject to the licenses and other rights granted herein, as between the Parties, except for Study Data, each Party shall own all right, title and interest in and to any and all: (i) Information and Inventions that are conceived, discovered, developed or otherwise made by or on behalf of such Party or its Affiliates under this Agreement, whether or not patented or patentable and (ii) Patents and other intellectual property rights with respect thereto, other than Joint Know-How and Joint Patents. Subject to the licenses and other rights granted herein, as between the Parties, Sanofi shall be the sole owner of, with all rights, title and interest in, all Study Data for clinical studies that are conducted by or on behalf of Sanofi. Subject to the licenses and other rights granted herein, as between the Parties, Lexicon shall be the sole owner of, with all rights, title and interest in, all Study Data for clinical studies that are conducted by or on behalf of Lexicon.
8.1.2.    Ownership of Joint Patents and Joint Know-How. Subject to the licenses and other rights granted herein and the last sentence of Section 8.1.1, as between the Parties, the Parties shall each own an equal, undivided interest in any and all: (i) Information and Inventions that are conceived, discovered, developed or otherwise made jointly by or on behalf of Lexicon or its Affiliates, on the one hand and Sanofi or its Affiliates, on the other hand, under this Agreement, whether or not patented or patentable (the “Joint Know-How”); and (ii) Patents (the “Joint Patents”) and other intellectual property rights with respect to the Information and Inventions described in clause (i) (together with Joint Know-How and Joint Patents, the “Joint Intellectual Property Rights”). Each Party shall promptly

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disclose to the other Party in writing and shall cause its Affiliates, and its and their licensees and (sub)licensees to so disclose, the development, making, conception or reduction to practice of any Joint Intellectual Property Rights. Subject to the licenses and other rights granted hereunder, except as otherwise prohibited hereunder, each Party shall have the right to practice or license the Joint Intellectual Property Rights without the consent of the other Party or a duty of accounting to the other Party (but for clarity, assignment of a Party’s interest in the Joint Intellectual Property Rights would require consent of the other Party).
8.1.3.    United States Law; Assignment. The determination of whether any Information and Inventions are conceived, discovered, developed or otherwise made by a Party for the purpose of allocating proprietary rights (including Patent, copyright or other intellectual property rights) as set forth in this ARTICLE 8, shall, for purposes of this Agreement, be made in accordance with Applicable Law in the United States irrespective of where or when such conception, discovery, reduction to practice, development or making occurs. To the extent necessary to give effect to Sections 8.1.1 and 8.1.2, each Party shall, and does hereby, assign, and shall cause its Affiliates to so assign, to the other Party, without additional compensation, such right, title and interest in and to any Information and Inventions (including Study Data), as well as any intellectual property rights with respect thereto, as is necessary to fully effect the allocation of ownership set forth in such Sections.
8.1.4.    Assignment Obligation. Each Party shall cause all Persons who perform Development or Manufacturing activities for such Party under or in connection with this Agreement or who conceive, discover, reduce to practice, develop or otherwise make any Information and Inventions by or on behalf of either Party or its Affiliates under or in connection with this Agreement to be under an obligation to assign (or, if such Party is unable to cause such Person to agree to such assignment obligation despite such Party’s using commercially reasonable efforts to negotiate such assignment obligation, provide a license under) their rights in any Information and Inventions resulting therefrom to such Party, except where Applicable Law requires otherwise and except in the case of governmental, not-for-profit and public institutions that have standard policies against such an assignment (in which case a suitable license, or right to obtain such a license, shall be obtained).
8.2.    Trademarks and Domain Names.
8.2.1.    Ownership of Product Trademarks. As between the Parties, Sanofi shall have the sole right to select and shall own all right, title and interest in and to the Product Trademarks on a worldwide basis. Lexicon shall not and shall not permit its Affiliates to (i) use in their respective businesses, any Trademark that is confusingly similar to, misleading or deceptive with respect to or that dilutes any (or any part) of the Product Trademarks and (ii) do any act that endangers, destroys, or similarly affects, in any material respect, the value of the goodwill pertaining to the Product Trademarks. Lexicon shall not and shall not permit its Affiliates to, attack, dispute or contest the validity of or ownership of any Product Trademark anywhere in the Territory or any registrations issued or issuing with respect thereto.
8.2.2.    Ownership of Corporate Names. As between the Parties, Lexicon shall retain all right, title and interest in and to its Corporate Names.
8.2.3.    Domain Names. Sanofi may, in exercising its rights under the licenses granted to it hereunder, register and use domain names used or intended for use in connection with the Commercialization of the Licensed Compounds and Licensed Products in the Field in the Territory (the

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Domain Names”). As between the Parties, the Domain Names shall be exclusively owned and operated by Sanofi, and Sanofi shall have the sole right to protect, maintain, enforce and defend the Domain Names, except as otherwise agreed by Sanofi in writing.
8.3.    Maintenance and Prosecution of Patents.
8.3.1.    Patent Prosecution and Maintenance of Lexicon Patents. As between the Parties, Lexicon shall have the first right, but not the obligation, using counsel of its own choice, to prepare, file, prosecute and maintain the Lexicon Patents worldwide including making decisions regarding any Opt-Out or Opt-In and to be responsible for any related interference, re-issuance, re-examination and, prior to the issuance of such Patent, opposition proceedings. Lexicon shall be responsible for all reasonable out-of-pocket costs and expenses incurred in connection with such prosecution and maintenance of Lexicon Patents. Lexicon shall periodically inform Sanofi of all material steps with regard to the preparation, filing, prosecution and maintenance of Lexicon Patents in the Major Markets in the Territory, including by providing Sanofi with a copy of material communications to and from any patent authority in the Major Markets in the Territory regarding such Lexicon Patents and by providing Sanofi drafts of any material filings or responses to be made to such patent authorities in the Major Markets in the Territory sufficiently in advance of submitting such filings or responses so as to allow for a reasonable opportunity for Sanofi to review and comment thereon. Lexicon shall consider in good faith the requests and suggestions of Sanofi with respect to such drafts and with respect to strategies for filing and prosecuting the Lexicon Patents in the Major Markets in the Territory. If, as between the Parties, Lexicon decides not to prepare, file, prosecute or maintain a Lexicon Patent in a country in the Territory entirely or with respect to the Licensed Products, Lexicon shall provide reasonable prior written notice to Sanofi of such intention and Sanofi shall thereupon have the option to assume the control and direction of the preparation, filing, prosecution and maintenance of such Lexicon Patent at its sole cost and expense in such country, unless Lexicon’s decision not to prepare, file, prosecute or maintain was based on a good faith desire to preserve the applicable invention as a trade secret or for good faith patent strategy reasons in each case relating to the Licensed Products.
8.3.2.    Patent Prosecution and Maintenance of Sanofi Patents. As between the Parties, Sanofi shall have the sole right, but not the obligation, to prepare, file, prosecute and maintain the Sanofi Patents worldwide including making decisions regarding any Opt-Out or Opt-In, and to be responsible for any related interference, re-issuance, re-examination and opposition proceedings, in each case, at its sole cost and expense and using counsel of its own choice.
8.3.3.    Patent Prosecution and Maintenance of Joint Patents. As between the Parties, Sanofi shall have the first right, but not the obligation, using counsel of its own choice, to prepare, file, prosecute and maintain the Joint Patents worldwide including making decisions regarding any Opt-Out or Opt-In and to be responsible for any related interference, re-issuance, re-examination and, prior to the issuance of such Patent, opposition proceedings. Sanofi shall be responsible for all reasonable out-of-pocket costs and expenses incurred in connection with such prosecution and maintenance of Joint Patents. Sanofi shall periodically inform Lexicon of all material steps with regard to the preparation, filing, prosecution and maintenance of Joint Patents in the Major Markets, including by providing Lexicon with a copy of material communications to and from any patent authority in the Major Markets regarding such Joint Patents and by providing Lexicon drafts of any material filings or responses to be made to such patent authorities in the Major Markets sufficiently in advance of submitting such filings or responses so as to allow for a reasonable opportunity for Lexicon to review and comment thereon. Sanofi shall consider in good faith the requests and suggestions of Lexicon with respect to such drafts and with respect

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to strategies for filing and prosecuting the Joint Patents in the Major Markets. If, as between the Parties, Sanofi decides not to prepare, file, prosecute or maintain a Joint Patent in a country, Sanofi shall provide reasonable prior written notice to Lexicon of such intention and Lexicon shall thereupon have the option to assume the control and direction of the preparation, filing, prosecution and maintenance of such Joint Patent at its sole cost and expense in such country, unless Sanofi’s decision not to prepare, file, prosecute or maintain was based on a good faith desire to preserve the applicable invention as a trade secret or for good faith patent strategy reasons. The prosecuting Party shall, at its sole discretion, determine the order in which the applicants’ names are listed in filings for Joint Patents.
8.3.4.    Cooperation. The non-prosecuting Party shall, and shall cause its Affiliates to, assist and cooperate with the prosecuting Party, as the prosecuting Party may reasonably request from time to time, in the preparation, filing, prosecution and maintenance of the Lexicon Patents, Sanofi Patents and Joint Patents in the Territory under this Agreement, including that the non-prosecuting Party shall, and shall ensure that its Affiliates, (i) offer its comments, if any, promptly, (ii) provide access to relevant documents and other evidence and make its employees available at reasonable business hours and (iii) provide the prosecuting Party, upon its request, with copies of any patentability search reports generated by its patent counsel with respect to the Lexicon Patents, Sanofi Patents or Joint Patents, including relevant Third Party patents and patent applications located; provided that neither Party shall be required to provide legally privileged information with respect to such intellectual property unless and until procedures reasonably acceptable to such Party are in place to protect such privilege.
8.3.5.    Patent Term Extension and Supplementary Protection Certificate. As between the Parties, Sanofi shall have the sole right to make decisions regarding, and to apply for, patent term extensions worldwide, including the United States with respect to extensions pursuant to 35 U.S.C. §156 et. seq. and in other jurisdictions pursuant to supplementary protection certificates, and in all jurisdictions with respect to any other extensions that are now or become available in the future, wherever applicable, for the Sanofi Patents, Lexicon Patents and any Joint Patents and with respect to the Licensed Compound and the Licensed Products, in each case including whether or not to do so; provided that with regard to the Lexicon Patents and any Joint Patents, the Parties shall engage in good faith consultations with respect to such decisions prior to such decisions. Lexicon shall provide prompt and reasonable assistance, as requested by Sanofi, including by taking such action as patent holder as is required under any Applicable Law to obtain such extension or supplementary protection certificate or Opt-Out or Opt-In in relation to any such supplementary protection certificate.
8.3.6.    Common Ownership Under Joint Research Agreements. Notwithstanding anything to the contrary in this ARTICLE 8, each Party shall have the right to invoke 35 U.S.C. 102(c) when exercising its rights under this ARTICLE 8 without the prior written consent of the other Party. A Party intending to invoke 35 U.S.C. 102(c) shall so notify the other Party, and the Parties shall coordinate their activities with respect to any submissions, filings or other activities in support thereof. The Parties acknowledge and agree that this Agreement is a “joint research agreement” as defined in 35 U.S.C. 100(h).
8.3.7.    Patent Listings. As between the Parties, Sanofi shall have the sole right to make all filings with Regulatory Authorities in the Territory with respect to the Sanofi Patents, Lexicon Patents and Joint Patents, including as required or allowed (i) in the United States, in the FDA’s Orange Book and (ii) in the European Union, under the national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83 or other international equivalents.

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8.3.8.    UPC Opt-Out and Opt-In. Sanofi (with respect to Sanofi Patents), Lexicon (with respect to Lexicon Patents), or Sanofi and Lexicon (with respect to Joint Patents), as applicable, shall, at Sanofi’s (with respect to Sanofi Patents and Joint Patents) and Lexicon’s (with respect to Lexicon Patents), as applicable, sole cost and expense, as soon as reasonably practicable on request by the prosecuting Party (i.e., pursuant to Section 8.3.1, Section 8.3.2 or Section 8.3.3, as applicable) (i) lodge an application with the Registry of the Unified Patent Court in the manner specified by Rule 5 of the Rules of Procedure of the Unitary Patent Court requesting the Opt-Out or Opt-In, as specified by the prosecuting Party, of any Lexicon Patent or Joint Patent specified by the prosecuting Party, (ii) pay the prescribed fee and make such submissions, and (iii) take such other actions as may be necessary or useful to secure the Opt Out or Opt-In, as applicable, of such Patent including making any declarations required by Rule 5(3)(e) of the Rules of Procedure of the Unitary Patent Court.
8.4.    Post Grant Proceedings.
8.4.1.    Challenges by Third Parties.
(i)    Lexicon Patents. If Lexicon learns that a Third Party has filed a Post Grant Proceeding regarding any Lexicon Patent, Lexicon shall notify Sanofi in writing of such Post Grant Proceeding no later than [**] after Lexicon learns of the filing. Once such Post Grant Proceeding has commenced, Lexicon shall provide to Sanofi:
(1)    a copy of any action, communication, letter, or other correspondence issued by the relevant Patent authority or the Third Party within [**] of receipt thereof;
(2)    a copy of any proposed response, amendment, paper, or other correspondence to be filed with the relevant Patent authority no less than [**] prior to making such filing. Sanofi may provide suggestions and recommendations regarding the content of the response, amendment, paper, or other correspondence at least [**] prior to its filing, which Lexicon shall consider in good faith; and
(3)    a copy of any response, amendment, paper, or other correspondence as filed with the relevant Patent authority no more than [**] after Lexicon receives confirmation from the relevant Patent authority that the response, amendment, paper, or other correspondence has been filed.
Lexicon agrees not to settle any Post Grant Proceeding filed by a Third Party regarding a Lexicon Patent without the prior written approval of Sanofi, not to be unreasonably withheld, conditioned or delayed.
(ii)    Joint Patents. If either Party learns that a Third Party has filed a Post Grant Proceeding regarding any Joint Patent, the Party who first learns of such Post Grant Proceeding shall notify the other Party in writing no later than [**] after the Party learns of the filing. Once such a Post Grant Proceeding has commenced, the prosecuting Party (i.e., pursuant to Section 8.3.1) shall provide to the other Party:
(1)    a copy of any proposed response, amendment, paper, or other correspondence to be filed with the relevant Patent authority no less than [**] prior to making such filing, unless otherwise agreed by counsel for both Parties. The non-prosecuting Party may provide suggestions and recommendations regarding the content of the response, amendment, paper, or other correspondence to the prosecuting Party at least [**] prior to its filing, which the prosecuting Party must consider in good

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faith. Unless otherwise agreed by the Parties, any response submitted to the United States Patent and Trademark Office shall be a joint response; and
(2)    a copy of any response, amendment, paper, or other correspondence as filed on behalf of Sanofi and Lexicon jointly with the relevant Patent authority no more than [**] after the prosecuting Party receives confirmation from the relevant Patent authority that the response, amendment, paper, or other correspondence has been filed.
The prosecuting Party agrees not to settle any Post Grant Proceeding filed by a Third Party regarding Joint Patent without the prior written approval of the non-prosecuting Party, which shall not be unreasonably withheld, conditioned or delayed.
8.4.2.    Challenge by a Party.
(i)    Should either Party wish to file a Post Grant Proceeding regarding a Lexicon Patent, such Party shall promptly notify the other Party in writing. Upon receipt of such notice, the Parties shall engage in good faith consultations about the merits of such a Post Grant Proceeding and whether it should be filed; provided, however, that Lexicon shall have final decision authority with respect to whether such a proceeding is filed. If such a Post Grant Proceeding is filed, Lexicon shall provide to Sanofi:
(1)    a copy of any action, communication, letter, or other correspondence issued by the relevant Patent authority within [**] of receipt thereof;
(2)    a copy of any response, amendment, paper, or other correspondence to be filed with the relevant Patent authority no less than [**] prior to making such filing, unless otherwise agreed by counsel for both Parties. Sanofi may provide suggestions and recommendations regarding the content of the response, amendment, paper, or other correspondence by no later than [**] prior to its filing, which Lexicon shall consider in good faith; and
(3)    a copy of any response, amendment, paper, or other correspondence as filed with the relevant Patent authority no more than [**] after Lexicon receives confirmation from the relevant Patent authority that the response, amendment, paper, or other correspondence has been filed.
Lexicon shall not settle such a Post Grant Proceeding without the prior written approval of Sanofi, not to be unreasonably withheld, conditioned or delayed.
(ii)    Joint Patents. Should either Party wish to file a Post Grant Proceeding regarding a Joint Patent, such Party shall promptly notify the other Party in writing. Upon receipt of such notice, the Parties shall engage in good faith consultations about the merits of such a Post Grant Proceeding and whether it should be filed; provided, however, that the prosecuting Party (i.e., pursuant to Section 8.3.1) shall have final decision authority with respect to whether such a proceeding should be filed. If such a Post Grant Proceeding is filed, the non-prosecuting Party shall refrain from filing any substantive response, amendment, paper or other correspondence with the relevant Patent authority, and the prosecuting Party shall provide to the non-prosecuting Party:
(1)    a copy of any action, communication, letter, or other correspondence issued by the relevant Patent authority within at least [**] of receipt thereof;

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(2)    a copy of any response, amendment, paper, or other correspondence to be filed with the relevant Patent authority no less than [**] prior to making such filing, unless otherwise agreed by counsel for both Parties. The non-prosecuting Party may provide suggestions and recommendations regarding the content of the response, amendment, paper, or other correspondence by no later than [**] prior to its filing. The prosecuting Party shall consider any suggestions or recommendations the non-prosecuting Party provides in good faith; and
(3)    a copy of any response, amendment, paper, or other correspondence as filed with the relevant Patent authority no more than [**] after the prosecuting Party receives confirmation from the relevant Patent authority that the response, amendment, paper, or other correspondence has been filed.
The prosecuting Party shall not settle such a Post Grant Proceeding without the prior written approval of the non-prosecuting Party, not to be unreasonably withheld, conditioned or delayed.
8.5.    Enforcement of Patents.
8.5.1.    Notice. Each Party shall promptly notify the other Party in writing and shall provide the other Party with a copy within [**] of receipt of (i) any alleged or threatened infringement of the Lexicon Patents, Sanofi Patents or Joint Patents in any jurisdiction in the Territory or (ii) any certification filed under the Hatch-Waxman Act claiming that any Lexicon Patents, Sanofi Patents or Joint Patents are invalid or unenforceable or claiming that any Lexicon Patents, Sanofi Patents or Joint Patents would not be infringed by the making, use, offer for sale, sale or import of a product for which an application under the Hatch-Waxman Act is filed or any equivalent or similar certification or notice in any other jurisdiction in the Territory, in each case ((i) and (ii)) of which such Party becomes aware. The foregoing requirements shall apply to the Sanofi Patents solely to the extent relating to Generic Products or other products that compete with Licensed Products. Any such infringement with respect to the Lexicon Patents, Joint Patents or Sanofi Patents shall constitute an “Infringement”.
8.5.2.    Enforcement of Lexicon Patents and Joint Patents. As between the Parties, Sanofi shall have the first right, but not the obligation, to prosecute any Infringement with respect to the Lexicon Patents and Joint Patents, including as a defense or counterclaim in connection with any Third Party Infringement Claim or action brought by a Third Party seeking a declaration of non-infringement of a Lexicon Patent or Joint Patent, at Sanofi’s sole cost and expense, using counsel of its own choice. In the event Sanofi prosecutes any such Infringement, Lexicon shall have the right to join as a party to such claim, suit or proceeding in the Territory and participate with its own counsel at its sole cost and expense; provided that Sanofi shall retain control of the prosecution of such claim, suit or proceeding, including the response to any defense or defense of any counterclaim raised in connection therewith. If Sanofi or its designee does not take commercially reasonable steps to prosecute an Infringement (i) within [**] following the first notice provided above with respect to such Infringement or (ii) provided such date occurs after the first such notice of such Infringement is provided, [**] before the time limit, if any, set forth in appropriate laws and regulations for filing of such actions, whichever comes first, then (x) Sanofi shall so notify Lexicon and (y) Lexicon may prosecute such alleged or threatened Infringement at its sole cost and expense.
8.5.3.    Enforcement of Sanofi Patents. As between the Parties, Sanofi shall have the sole right, but not the obligation, to prosecute Infringement with respect to the Sanofi Patents, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at Sanofi’s

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sole cost and expense, using counsel of its own choice, and Sanofi shall retain control of the prosecution of such suit.
8.5.4.    Cooperation. The Parties agree to cooperate fully in any Infringement action pursuant to this Section 8.5, including by making the inventors, applicable records and documents (including laboratory notebooks) of the relevant Patents available to the controlling Party upon the controlling Party’s request. Where a Party controls such an action, the other Party shall, and shall cause its Affiliates to, assist and cooperate with the controlling Party, as such controlling Party may reasonably request from time to time, in connection with its activities set forth in this Section 8.5, including where necessary, furnishing a power of attorney solely for such purpose or joining in, or being named as a necessary party to, such action, providing access to relevant documents and other evidence and making its employees available at reasonable business hours; provided that, except with respect to Joint Patents, the controlling Party shall reimburse such other Party for its reasonable and verifiable out-of-pocket costs and expenses incurred in connection therewith. Unless otherwise set forth herein, the Party entitled to bring any patent infringement litigation in accordance with this Section 8.5 shall have the right to settle such claim; provided that neither Party shall have the right to settle any Infringement litigation under this Section 8.5 in a manner that has a material adverse effect on the rights or interest of the other Party or in a manner that imposes any costs or liability on, or involves any admission by, the other Party, without the express written consent of the other Party (which consent shall not be unreasonably withheld, conditioned or delayed). In connection with any activities with respect to an Infringement action prosecuted by a Party pursuant to this Section 8.5 involving Patents Controlled by the other Party or licensed under Section 2.1 to the other Party, the Party controlling such action shall (i) consult with the other Party as to the strategy for the prosecution of such claim, suit or proceeding, (ii) consider in good faith any comments from the other Party with respect thereto and (iii) keep the other Party reasonably informed of any material steps taken and provide copies of all material documents filed, in connection with such action.
8.5.5.    Recovery. Except as otherwise agreed by the Parties in connection with a separate written cost sharing arrangement, any recovery realized as a result of such litigation described above in this Section 8.5 (whether by way of settlement or otherwise) shall be first allocated to reimburse the Parties for their costs and expenses in making such recovery (which amounts shall be allocated pro rata if insufficient to cover the totality of such expenses). [**] of any remainder after such reimbursement is made shall be retained by the Party that has exercised its right to bring the enforcement action and [**] of any such remainder shall be paid to the other Party.
8.6.    Invalidity or Unenforceability Defenses or Actions. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity or unenforceability of any of the Lexicon Patents, Sanofi Patents or Joint Patents by a Third Party of which such Party becomes aware. In the event that such allegation or threatened assertion arises in connection with a proceeding covered by Section 8.5, the allocation of rights and responsibilities, including with respect to costs and recoveries, shall be governed by Section 8.5. For all other allegations or threatened assertions, the provisions of Section 8.4 shall govern the Parties’ rights and obligations with respect to such action, as if such action were a Post Grant Proceeding.
8.7.    Infringement Claims by Third Parties. If the Exploitation of a Licensed Product in the Territory pursuant to this Agreement results in, or is reasonably expected to result in, any claim, suit or proceeding by a Third Party alleging infringement by Sanofi or any of its Affiliates or its or their Sublicensees, Distributors or customers (a “Third Party Infringement Claim”), including any defense or counterclaim in connection with an Infringement action initiated pursuant to Section 8.5 the Party first

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becoming aware of such alleged infringement shall promptly notify the other Party thereof in writing. As between the Parties, Sanofi shall have the first right, but not the obligation, to defend and control the defense of any such claim, suit or proceeding at its sole cost and expense, using counsel of its own choice. Lexicon may participate in any such claim, suit or proceeding with counsel of its choice at its sole cost and expense. If Sanofi or its designee elects (in a written communication submitted to Lexicon within a reasonable amount of time after notice of the alleged patent infringement) not to defend or control the defense of, or otherwise fails to initiate and maintain the defense of, any such claim, suit or proceeding, within such time period so that Lexicon is not prejudiced by any delays, Lexicon may conduct and control the defense of any such claim, suit or proceeding at its sole cost and expense. Where a Party controls such an action, the other Party shall, and shall cause its Affiliates to, assist and cooperate with the controlling Party, as such controlling Party may reasonably request from time to time, in connection with its activities set forth in this Section 8.7, including where necessary, furnishing a power of attorney solely for such purpose or joining in, or being named as a necessary party to, such action, providing access to relevant documents and other evidence and making its employees available at reasonable business hours; provided that the controlling Party shall reimburse such other Party for its reasonable and verifiable out-of-pocket costs and expenses incurred in connection therewith. Each Party shall keep the other Party reasonably informed of all material developments in connection with any such claim, suit or proceeding.
8.8.    Third Party Rights. Sanofi may, at its election, acquire from a Third Party any license to any Patent or other intellectual property right that it views as necessary or useful to the Exploitation of the Licensed Compound or Licensed Product by Sanofi or any of its Affiliates or any of its or their Sublicensees, Distributors or customers in order to avoid infringement or misappropriation of any Patent, trade secret or other intellectual property right of a Third Party in any country in the Territory (such right, a “Third Party Right”). In the event that Sanofi negotiates and obtains any such license that meets the criteria in Section 7.3.3(ii), then Section 7.3.3(ii) shall apply.
8.9.    Product Trademarks.
8.9.1.    Prosecution of Product Trademarks. Sanofi shall have the sole right to register, prosecute and maintain the Product Trademarks using counsel of its own choice. All costs and expenses of registering, prosecuting and maintaining the Product Trademarks shall be borne solely by Sanofi.
8.9.2.    Enforcement of Product Trademarks. Sanofi shall have the sole right to take such action as Sanofi deems necessary against a Third Party based on any alleged, threatened or actual infringement, dilution, misappropriation or other violation of or unfair trade practices or any other like offense relating to, the Product Trademarks by a Third Party in the Territory at its sole cost and expense and using counsel of its own choice. Sanofi shall retain any damages or other amounts collected in connection therewith.
8.9.3.    Third Party Claims. Sanofi shall have the sole right to defend against and settle any alleged, threatened or actual claim by a Third Party that the use or registration of the Product Trademarks in the Territory infringes, dilutes, misappropriates or otherwise violates any Trademark or other right of that Third Party or constitutes unfair trade practices or any other like offense or any other claims as may be brought by a Third Party against a Party in connection with the use of the Product Trademarks with respect to a Licensed Product in the Territory at its sole cost and expense and using counsel of its own choice. Sanofi shall retain any damages or other amounts collected in connection therewith.

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8.9.4.    Cooperation. Lexicon shall, and shall cause its Affiliates to, assist and cooperate with Sanofi, as Sanofi may reasonably request from time to time, in connection with its activities set forth in this Section 8.9, including where necessary, furnishing a power of attorney solely for such purpose or joining in, or being named as a necessary party to, such action, providing access to relevant documents and other evidence and making its employees available at reasonable business hours; provided that Sanofi shall reimburse Lexicon for its reasonable and verifiable out-of-pocket costs and expenses incurred in connection therewith.

ARTICLE 9
CONFIDENTIALITY AND NON-DISCLOSURE

9.1.    Confidentiality Obligations. At all times during the Term and for a period of [**] following termination or expiration of this Agreement in its entirety, each Party shall and shall cause its officers, directors, employees and agents to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement. “Confidential Information” means any technical, business or other information provided by or on behalf of one Party to the other Party in connection with this Agreement, whether prior to, on or after the Effective Date, including the terms of this Agreement, information relating to the Licensed Compound or any Licensed Product (including the Regulatory Documentation), any Exploitation of the Licensed Compound or any Licensed Product, any Know-How with respect thereto developed by or on behalf of the disclosing Party or its Affiliates or, in the case of Sanofi, its or their Sublicensees (including Sanofi Know-How and Lexicon Know-How, as applicable) or the scientific, regulatory or business affairs or other activities of either Party. Notwithstanding the foregoing, Confidential Information constituting (i) Regulatory Documentation owned by Sanofi pursuant to Section 3.2 shall be deemed the Confidential Information of Sanofi (and Sanofi shall be deemed to the disclosing Party and Lexicon shall be deemed the receiving Party with respect thereto) and (ii) any Joint Know-How and the terms of this Agreement shall be deemed to be the Confidential Information of both Parties (and both Parties shall be deemed to be the receiving Party and the disclosing Party with respect thereto). Notwithstanding the foregoing, the confidentiality and non-use obligations under this Section 9.1 with respect to any Confidential Information shall not include any information that:
9.1.1.    is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no breach of this Agreement by the receiving Party;
9.1.2.    can be demonstrated by documentation or other competent proof to have been in the receiving Party’s possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; provided that the foregoing exception shall not apply with respect to Confidential Information constituting Joint Know-How or otherwise described in clauses (i) or (ii) of Section 9.1;
9.1.3.    is subsequently received by the receiving Party from a Third Party who is not bound by any obligation of confidentiality with respect to such information;
9.1.4.    has been published by a Third Party or otherwise enters the public domain through no fault of the receiving Party in breach of this Agreement; or

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9.1.5.    can be demonstrated by documentation or other competent evidence to have been independently developed by or for the receiving Party without reference to the disclosing Party’s Confidential Information.
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the combination and its principles are in the public domain or in the possession of the receiving Party.
9.2.    Permitted Disclosures.
9.2.1.    Either Party may disclose to bona fide potential investors, lenders and acquirors, and to such Party’s consultants and advisors, the existence and terms of this Agreement to the extent necessary in connection with a proposed equity or debt financing of such Party, or a proposed acquisition or business combination, and Lexicon may make such disclosures as are necessary for Lexicon to comply with its reporting obligations under the T1DM Funding Agreements, in each case, so long as such recipients are bound in writing to maintain the confidentiality of such information to the extent the Party making such disclosure remains subject to a confidentiality obligation as to such information under this Agreement.
9.2.2.    Each Party may disclose Confidential Information to the extent that such disclosure is made in response to a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial or local governmental or regulatory body of competent jurisdiction or if such disclosure is otherwise required by law, including in order to comply with applicable securities laws or regulations or the rules or regulations of any stock exchange on which securities of the Party making such disclosure are traded; provided, however, that the receiving Party shall, if practicable, first have notified the disclosing Party of such requirement so that the disclosing Party may seek to quash such order or to obtain a protective order for confidential treatment with respect to such disclosure; provided, further, that the Confidential Information disclosed in response to such court or governmental order or other legal requirement shall be limited to that information which is legally required to be disclosed in response to such court or governmental order.
9.2.3.    Either Party may disclose Confidential Information to the extent such disclosure if (i) reasonably necessary for the filing or prosecuting Patents as contemplated by ARTICLE 8; or (ii) is reasonably necessary in connection with regulatory filings for the Licensed Products in the Field consistent with this Agreement.
9.3.    Additional Permitted Disclosures by Sanofi. Sanofi and its Affiliates and its and their Sublicensees may disclose Confidential Information of Lexicon as may be necessary or useful in connection with the Exploitation of the Licensed Products (including the Licensed Compounds therein) (including in connection with any filing, application or request for Regulatory Approval by or on behalf of Sanofi or any of its Affiliates or its or their Sublicensees) or otherwise in connection with the performance of its obligations or exercise of Sanofi’s rights as contemplated by this Agreement, including to existing or potential Distributors, Sublicensees, collaboration partners or acquirers.

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9.4.    Use of Name. Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo or Trademark of the other Party or any of its Affiliates or any of its or their Sublicensees (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material or other form of publicity without the prior written approval of such other Party in each instance. The restrictions imposed by this Section 9.5 shall not prohibit (i) Sanofi from making any disclosure identifying Lexicon to the extent required in connection with its exercise of its rights or obligations under this Agreement, (ii) either Party from making any disclosure identifying the other Party that is required by Applicable Law or the rules of a stock exchange on which the securities of the disclosing Party are listed (or to which an application for listing has been submitted) or (iii) either Party from making any disclosure identifying the other Party that has then previously been made in accordance with the terms of this Agreement provided that such disclosure remains accurate as of such time and provided the frequency and form of such disclosure are reasonable.
9.5.    Public Announcements. The Parties have agreed upon the content of one (1) or more press releases which shall be issued in the form(s) attached hereto as Schedule 9.5, the release of which the Parties shall coordinate in order to accomplish such release promptly following the Execution Date. Neither Party shall issue any other public announcement, press release or other public disclosure regarding this Agreement or its subject matter without the other Party’s prior written consent (which consent shall not be unreasonably withheld, delayed or conditioned), except for any such disclosure that is required by Applicable Law or the rules of a stock exchange on which the securities of the disclosing Party are listed (or to which an application for listing has been submitted). In the event a Party is required by Applicable Law or the rules of a stock exchange on which its securities are listed (or to which an application for listing has been submitted) to make such a public disclosure, such Party shall submit the proposed disclosure in writing to the other Party as far in advance as reasonably practicable (and in no event less than [**] prior to the anticipated date of disclosure except as may be required by Applicable Law or the rules of an applicable stock exchange) so as to provide a reasonable opportunity to comment thereon. Neither Party shall be required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement or any amendment hereto that has already been publicly disclosed by such Party or by the other Party, in accordance with this Section 9.5 or Section 9.9, provided that such information remains accurate as of such time and provided the frequency and form of such disclosure are reasonable.
9.6.    Publications. The Parties recognize the desirability of publishing and publicly disclosing the results of and information regarding, activities under this Agreement. Accordingly, each Party shall be free to publicly disclose the results of and information regarding, its activities under this Agreement, subject to prior review by the other Party of any disclosure of the other Party’s Confidential Information for issues of patentability and protection of such Confidential Information, in a manner consistent with Applicable Law and industry practices, as provided in this Section 9.7. Accordingly, prior to publishing or disclosing any of the other Party’s Confidential Information, the publishing Party shall provide the other Party with drafts of proposed abstracts, manuscripts or summaries of presentations that cover such Confidential Information. The non-publishing Party shall respond promptly through its designated representative and in any event no later than [**] after receipt of such proposed publication or presentation or such shorter period as may be required by the publication or presentation. The publishing Party agrees to allow a reasonable period (not to exceed [**]) to permit filings for patent protection and to otherwise address issues of Confidential Information or related competitive harm to the reasonable satisfaction of the other Party.

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9.7.    Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, either Party may request in writing and the non-requesting Party shall either (at the non-requesting Party’s election), with respect to Confidential Information to which such non-requesting Party does not retain rights under the surviving provisions of this Agreement: (i) promptly destroy all copies of such Confidential Information in the possession or control of the non-requesting Party and confirm such destruction in writing to the requesting Party; or (ii) promptly deliver to the requesting Party all copies of such Confidential Information in the possession or control of the non-requesting Party. Notwithstanding the foregoing, the non-requesting Party shall be permitted to retain such Confidential Information (x) to the extent necessary or useful for purposes of performing any continuing obligations or exercising any ongoing rights hereunder and, in any event, a single copy of such Confidential Information for archival purposes and (y) any computer records or files containing such Confidential Information that have been created solely by such non-requesting Party’s automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such non-requesting Party’s standard archiving and back-up procedures, but not for any other uses or purposes. All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in Section 9.1.
9.8.    Privileged Communications. In furtherance of this Agreement, it is expected that the Parties will, from time to time, disclose to one another privileged communications with counsel, including opinions, memoranda, letters and other written, electronic and verbal communications. Such disclosures are made with the understanding that they shall remain confidential in accordance with this ARTICLE 9, that they will not be deemed to waive any applicable attorney-client or attorney work product or other privilege and that they are made in connection with the shared community of legal interests existing between Sanofi and Lexicon, including the community of legal interests in avoiding infringement of any valid, enforceable patents of Third Parties and maintaining the validity of the Sanofi Patents, Lexicon Patents and Joint Patents. In the event of any litigation (or potential litigation) with a Third Party related to this Agreement or the subject matter hereof, the Parties shall, upon either Party’s request, enter into a reasonable and customary joint defense agreement. In any event, each Party shall consult in a timely manner with the other Party before engaging in any conduct (e.g., producing information or documents) in connection with litigation or other proceedings that could conceivably implicate privileges maintained by the other Party. Notwithstanding anything contained in this Section 9.8, nothing in this Agreement shall prejudice a Party’s ability to take discovery of the other Party in disputes between them relating to the Agreement and no information otherwise admissible or discoverable by a Party shall become inadmissible or immune from discovery solely by this Section 9.8.
9.9.    Form 8-K. The Parties have agreed upon the content of Lexicon’s Form 8-K containing the press release in Schedule 9.5, which shall be issued in the form(s) attached hereto as Schedule 9.9.
ARTICLE 10
REPRESENTATIONS AND WARRANTIES

10.1    Mutual Representations and Warranties. Lexicon and Sanofi each represents and warrants to the other, as of the Execution Date and as of the Effective Date, that:
10.1.1    It is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization and has all requisite power and authority, corporate or otherwise, to execute, deliver and perform this Agreement;

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10.1.2.    The execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action and do not violate: (i) such Party’s charter documents, bylaws or other organizational documents; (ii) in any material respect, any agreement, instrument or contractual obligation to which such Party is bound; (iii) any requirement of any Applicable Law; or (iv) any order, writ, judgment, injunction, decree, determination or award of any court or governmental agency presently in effect applicable to such Party;
10.1.3    This Agreement is a legal, valid and binding obligation of such Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance and general principles of equity (whether enforceability is considered a proceeding at law or equity); and
10.1.4.    It is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement or that would impede the diligent and complete fulfillment of its obligations hereunder.
10.2.    Additional Representations and Warranties of Lexicon. Lexicon further represents and warrants to Sanofi, as of the Execution Date, as follows:
10.2.1.    Lexicon is entitled to grant the rights and licenses specified herein, including the rights and licenses granted pursuant to this Agreement under all Regulatory Documentation, Information and Inventions and Patents to Exploit the Licensed Compound and Licensed Products as contemplated under this Agreement;
10.2.2.    All Lexicon Patents existing as of the Execution Date (the “Existing Patents”) are listed on Schedule 10.2.2 and all Existing Patents existing as of the Execution Date are (i) to the extent issued, to Lexicon’s knowledge (unless otherwise indicated on Schedule 10.2.2), subsisting and not invalid or unenforceable, in whole or in part, (ii) solely and exclusively owned or exclusively licensed by Lexicon (unless otherwise indicated on Schedule 10.2.2), free of any encumbrance, lien or claim of ownership by any Third Party, (iii) to the extent pending, being diligently prosecuted in the respective patent offices in which such applications have been filed in accordance with Applicable Law and Lexicon and its Affiliates have presented such relevant references, documents and information as required in order to comply with its duty of disclosure to the applicable patent office and (iv) filed and maintained properly and correctly and all applicable fees applicable thereto have been paid on or before the due date for payment;
10.2.3.    True, complete and correct copies of (i) the file wrappers relating to the Existing Patents and (ii) all T1DM Funding Agreements, in each case ((i) and (ii)) have been made available to Sanofi prior to the Execution Date;
10.2.4.    As of the Execution Date, there are no license or other agreements with Third Parties regarding any intellectual property rights licensed hereunder, including the Existing Patents, to which Lexicon is a party (“In-License Agreements”);
10.2.5.    The Existing Patents represent all Patents that Lexicon or its Affiliates own, Control or otherwise have rights to relating to the Licensed Compound or the Licensed Products or the Exploitation thereof, as of the Execution Date. To Lexicon’s knowledge, there is no Information and Inventions owned by or otherwise in the possession or control of Lexicon or any of its Affiliates as of the

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Execution Date that relates to the Licensed Compound or the Licensed Products that is not within the Lexicon Know-How. To Lexicon’s knowledge, no rights or licenses are required under the Existing Patents or Lexicon Know-How for Sanofi to Exploit the Licensed Compound and the Licensed Products as contemplated herein other than those granted under Section 2.1;
10.2.6.    Neither Lexicon nor any of its Affiliates has previously entered into any agreement, whether written or oral, assigning, transferring, licensing, conveying or otherwise encumbering its right, title or interest in or to the Existing Patents, Lexicon Know-How, Regulatory Documentation, the Licensed Compound or the Licensed Products (including by granting any covenant not to sue with respect thereto) or any Patent or other intellectual property or proprietary right or Information and Inventions that would be Existing Patents, Lexicon Know-How or Regulatory Documentation but for such assignment, transfer, license, conveyance or encumbrance and has not entered into any agreement agreeing to do any of the foregoing, in each case other than non-exclusive licenses granted to Third Party services providers to enable such services providers to perform the services for which they were contracted by Lexicon or its Affiliates;
10.2.7.    To Lexicon’s knowledge, no claim or litigation has been brought or asserted by any Person alleging that (i) the Existing Patents are invalid or unenforceable or (ii) the conception, development, reduction to practice, disclosing, copying, making, assigning or licensing of the Existing Regulatory Documentation, the Existing Patents or the Lexicon Know-How existing as of the Execution Date or the Exploitation of the Licensed Compound or Licensed Products as contemplated herein, violates, infringes, constitutes misappropriation or otherwise conflicts or interferes with or would violate, infringe or otherwise conflict or interfere with, any intellectual property or proprietary right of any Person;
10.2.8.    Lexicon has obtained from its Affiliates the licenses and other rights necessary for Lexicon to grant to Sanofi the rights and licenses provided herein and for Sanofi to perform its obligations hereunder;
10.2.9.    The Exploitation of the Licensed Compound or the Licensed Products as contemplated herein will not be subject to any other license or agreement to which Lexicon or any of its Affiliates is a party as of the Execution Date, other than the T1DM Funding Agreements;
10.2.10. There are no amounts that will be required to be paid to a Third Party as a result of the Exploitation of the Licensed Products that arise out of any agreement to which Lexicon or any of its Affiliates is a party, other than the T1DM Funding Agreements;
10.2.11.    To Lexicon’s knowledge, no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Existing Patents, the Lexicon Know-How or the Regulatory Documentation;
10.2.12. To Lexicon’s knowledge, each of the Existing Patents properly identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Existing Patent is issued or such application is pending;
10.2.13. Each Person who has or has had any rights in or to any Existing Patents or any Lexicon Know-How, has assigned and has executed an agreement assigning its entire right, title and interest in and to such Existing Patents and Lexicon Know-How to Lexicon. All Inventor Personnel of Lexicon have executed and delivered to Lexicon or such Affiliate an assignment or other agreement regarding the protection of proprietary information and the assignment to Lexicon or such Affiliate of any

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Lexicon Patents, Lexicon Know-How and any and all other Information and Inventions that relate to the Licensed Compound or Licensed Products, the current form of which has been made available for review by Sanofi. To Lexicon’s knowledge, no current officer, employee, agent or consultant of Lexicon or any of its Affiliates is in violation of any term of any assignment or other agreement regarding the protection of Patents or other intellectual property or proprietary information of Lexicon or such Affiliate or of any employment contract or any other contractual obligation relating to the relationship of any such Person with Lexicon;
10.2.14. All material works of authorship and all other material materials subject to copyright protection included in Lexicon Know-How are original and were either created by employees of Lexicon or its Affiliates within the scope of their employment or are otherwise works made for hire and all right, title and interest in and to such materials have been legally and fully assigned and transferred to Lexicon or such Affiliate;
10.2.15. Lexicon has obtained the right (including under any Patents and other intellectual property rights) to use all Information and Inventions and all other materials (including any formulations and manufacturing processes and procedures) developed or delivered by any Third Party under any agreements between Lexicon and any such Third Party with respect to the Licensed Compound and the Licensed Product and Lexicon has the rights under each such agreement to transfer such rights, Information and Inventions or other materials to Sanofi and its designees and to grant Sanofi the right to use such rights, Information and Inventions or other materials in the Exploitation of the Licensed Compound or the Licensed Products as contemplated hereunder without restriction;
10.2.16. The inventions Covered by the Existing Patents (i) were not conceived, discovered, developed or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof and (ii) are not a “subject invention” as that term is described in 35 U.S.C. Section 201(e) and (iii) are not otherwise subject to the provisions of the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 U.S.C. §§ 200-212, as amended, as well as any regulations promulgated pursuant thereto, including in 37 C.F.R. Part 401;
10.2.17. Lexicon has made available to Sanofi all material Regulatory Documentation, Lexicon Know-How and other Information and Inventions in its possession or Control related to the Licensed Compound or the Licensed Products and all such Regulatory Documentation, Lexicon Know-How and other Information and Inventions are, to Lexicon’s knowledge, true, complete and correct in all material respects;
10.2.18. The Lexicon Know-How that Lexicon has determined, in the exercise of reasonable business discretion, to maintain as confidential, has been kept confidential or has been disclosed to Third Parties only under terms of confidentiality. To the knowledge of Lexicon and its Affiliates no breach of such confidentiality has been committed by any Third Party;
10.2.19. Lexicon and its Affiliates have generated, prepared, maintained and retained all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law and all such information is true, complete and correct and what it purports to be;

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10.2.20. Neither Lexicon nor any of its Affiliates, nor any of its or their respective officers, employees or agents has (i) committed an act, (ii) made a statement or (iii) failed to act or make a statement that, in any case ((i), (ii) (iii)), that (x) would be or create an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the Exploitation of the Licensed Compound or the Licensed Products or (y) could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any analogous laws or policies in the Territory, with respect the Exploitation of the Licensed Compound or the Licensed Products;
10.2.21. Lexicon and its Affiliates have conducted, and to Lexicon’s knowledge, their respective contractors and consultants have conducted, all Development of the Licensed Compound and the Licensed Products in accordance with in all material respects, to the extent applicable, good laboratory, pharmacovigilance and clinical practice and Applicable Law. Lexicon and its Affiliates have, to Lexicon’s knowledge, employed Persons with appropriate education, knowledge and experience to conduct and to oversee the conduct of the pre-clinical and clinical studies with respect to the Licensed Compound and Licensed Products;
10.2.22. True, complete and correct copies (as of the Execution Date) of all material adverse information with respect to the safety and efficacy of the Licensed Compound and the Licensed Products known to Lexicon have been provided to Sanofi prior to the Execution Date;
10.2.23. Neither Lexicon nor any of its Affiliates has been debarred or is subject to debarment and neither it nor any of its Affiliates will use in any capacity, in connection with the services to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA or who is the subject of a conviction described in such section; and
10.2.24. With respect to any Licensed Compound or Licensed Product Manufactured and supplied by or on behalf of Lexicon, (i) all such Licensed Compound and Licensed Product has been Manufactured in conformity with the applicable specifications for such Licensed Compound and Licensed Product, (ii) such Licensed Compound and Licensed Product has been Manufactured in conformance with cGMP and all other Applicable Law, (iii) such Licensed Compound and Licensed Product has been Manufactured in facilities that are in compliance with Applicable Law at the time of such Manufacture, and (iv) such Licensed Compound and Licensed Product is not and has not been adulterated or misbranded under the FFDCA and similar provisions of the laws of the other Major Markets.
10.3.    Additional Covenants of Lexicon. Lexicon hereby covenants, as of the Execution Date, as follows:
10.3.1.    During the period from the Execution Date through the end of the Term of this Agreement, Lexicon shall obtain from each of its Affiliates, (sub)licensees (other than Sublicensees), employees and agents, and from the employees and agents of its Affiliates, (sub)licensees (other than Sublicensees) and agents, who are or will be involved in the Manufacture of Licensed Products or are otherwise participating in the Exploitation of the Licensed Compounds or Licensed Products or who otherwise have access to any Confidential Information of Sanofi, rights to any and all Information and Inventions that relate to the Licensed Compound or Licensed Products and are generated pursuant to and during the time of such Person’s relationship with Lexicon or its Affiliate, such that Sanofi shall, by virtue

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of this Agreement, receive from Lexicon, without payments beyond those required by this Agreement, the licenses and other rights granted to Sanofi hereunder (and such that the scope of such licenses and other rights are not limited in scope or exclusivity by a failure to so obtain such rights from such Persons);
10.3.2.    During the period from the Execution Date until the Effective Date, Lexicon and its Affiliates shall conduct Exploitation with respect to the Licensed Products in the ordinary course and shall not initiate any Phase 3 clinical studies for any of the Licensed Products for T2DM prior to the Effective Date;
10.3.3.    Neither Lexicon nor any of its Affiliates will enter into any agreements, grant any right, title or interest to any Person that conflicts with or violates the rights and licenses granted to Sanofi under this Agreement;
10.3.4.    Future Inventor Personnel of Lexicon will execute and deliver to Lexicon or its applicable Affiliate an assignment or other agreement regarding the protection of proprietary information and the assignment to Lexicon or such Affiliate of any Lexicon Patents, Lexicon Know-How, Joint Patents, Joint Know-How and any and all other Information and Inventions that relate to the Licensed Compound or Licensed Products, the current form of which has been made available for review by Sanofi;
10.3.5.    Lexicon will make available to Sanofi all material Regulatory Documentation, Lexicon Know-How, Joint Know-How and other Information and Inventions in its possession or Control related to the Licensed Compound or the Licensed Products;
10.3.6.    Neither Lexicon nor any of its Affiliates, nor any of its or their respective officers, employees or agents shall (i) commit an act, (ii) make a statement or (iii) fail to act or make a statement that, in any case ((i), (ii) (iii)), that (x) would be or create an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the Exploitation of the Licensed Compound or the Licensed Products or (y) could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any analogous laws or policies in the Territory, with respect the Exploitation of the Licensed Compound or the Licensed Products;
10.3.7.    Lexicon and its Affiliates shall, and shall cause their respective contractors and consultants to conduct, all Development of the Licensed Compound and the Licensed Products in accordance with in all material respects, to the extent applicable, good laboratory, pharmacovigilance and clinical practice and Applicable Law. Lexicon and its Affiliates shall employ Persons with appropriate education, knowledge and experience to conduct and to oversee the conduct of the pre-clinical and clinical studies with respect to the Licensed Compound and Licensed Products;
10.3.8.    In the event that any Patents or Information and Inventions Controlled by Lexicon or its Affiliates as of the Execution Date would be Lexicon Patents or Lexicon Know-How, as applicable, if such Patent or Know-How were Controlled by Lexicon or its Affiliates as of the Effective Date, then Lexicon agrees that during the period from the Execution Date until the Effective Date, it shall not and shall cause its Affiliates not to (i) incur, create, assume or permit the incurrence, creation or assumption of any encumbrance, lien or claim of ownership by any Third Party with respect to such Patents or Information and Inventions, (ii) dispose of any of such Patents or Information and Inventions,

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or (iii) waive, release, grant, license or transfer any right, title or interest in or to any such Patents or Information and Inventions in any manner that would limit the scope of the Intellectual Property Rights included in, or the exclusivity of the license rights granted in Section 2.1; and
10.3.9.    Lexicon agrees to inform Sanofi in writing promptly if it or any Person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 of the FFDCA or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of its or its Affiliates’ knowledge, is threatened, relating to the debarment or conviction of it or any such Person performing services hereunder.
10.4.    Additional Covenants of Sanofi. Sanofi hereby covenants, as of the Execution Date, as follows:
10.4.1.    During the period from the Execution Date through the end of the Term of this Agreement, Sanofi shall obtain from each of its Affiliates, (sub)licensees (other than Sublicensees), employees and agents, and from the employees and agents of its Affiliates, (sub)licensees (other than Sublicensees) and agents, who are or will be involved in the Manufacture of Licensed Products or are otherwise participating in the Exploitation of the Licensed Compounds or Licensed Products or who otherwise have access to any Confidential Information of Lexicon, rights to any and all Information and Inventions that relate to the Licensed Compound or Licensed Products and are generated pursuant to and during the time of such Person’s relationship with Sanofi or its Affiliate, such that Lexicon shall, by virtue of this Agreement, receive from Sanofi, without payments beyond those required by this Agreement, the licenses and other rights granted to Lexicon hereunder (and such that the scope of such licenses and other rights are not limited in scope or exclusivity by a failure to so obtain such rights from such Persons);
10.4.2.    Neither Sanofi nor any of its Affiliates will enter into any agreements, grant any right, title or interest to any Person that violates the rights and licenses granted to Lexicon under this Agreement;
10.4.3.    Future Inventor Personnel of Sanofi will be subject to an assignment or other agreement regarding the protection of proprietary information and the assignment to Sanofi or such Affiliate of any Sanofi Patents, Sanofi Know-How, Joint Patents, Joint Know-How and any and all other Information and Inventions that relate to the Licensed Compound or Licensed Products;
10.4.4.    Sanofi will make available to Lexicon all material Regulatory Documentation, Joint Know-How and other Information and Inventions in its possession or Control related to the Licensed Compound or the Licensed Products;
10.4.5.    Neither Sanofi nor any of its Affiliates, nor any of its or their respective officers, employees or agents shall (i) commit an act, (ii) make a statement or (iii) fail to act or make a statement that, in any case ((i), (ii) (iii)), that (x) would be or create an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the Exploitation of the Licensed Compound or the Licensed Products or (y) could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any analogous laws or policies in the Territory, with respect the Exploitation of the Licensed Compound or the Licensed Products;

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10.4.6.    Sanofi and its Affiliates shall, and shall cause their respective contractors and consultants to conduct, all Development of the Licensed Compound and the Licensed Products in accordance with in all material respects, to the extent applicable, good laboratory, pharmacovigilance and clinical practice and Applicable Law. Sanofi and its Affiliates shall employ Persons with appropriate education, knowledge and experience to conduct and to oversee the conduct of the pre-clinical and clinical studies with respect to the Licensed Compound and Licensed Products; and
10.4.7.    Sanofi agrees to inform Lexicon in writing promptly if it or any Person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306 of the FFDCA or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of its or its Affiliates’ knowledge, is threatened, relating to the debarment or conviction of it or any such Person performing services hereunder.
10.5.    DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
10.6.    Anti-Bribery and Anti-Corruption Compliance. With respect to the Exploitation of Licensed Products, each Party further represents and warrants to the other Party, as of the Execution Date, and covenants, as follows:
10.6.1.    It is licensed, registered, or qualified under Applicable Law to do business, and, except for the HSR Filings and clearances under the HSR Act, has obtained such licenses, consents or authorizations or completed such registrations or made such notifications as may be necessary or required by Applicable Law;
10.6.2.    It has not taken and will not, as of the Execution Date or at any time during the Term, take any action directly or indirectly to offer, promise or pay, or authorize the offer or payment of, any money or anything of value in order to improperly or corruptly seek to influence any Government Official or any other person in order to gain an improper advantage, and has not accepted, and will not accept in the future such payment;
10.6.3    It complies with Applicable Law where it operates, including Anti-Corruption Laws, accounting and record keeping laws, and laws relating to interactions with healthcare professionals or healthcare providers and Government Officials; and
10.6.4.    It is, as between the Parties, solely responsible to ensure it and its Affiliates compliance, in all material respects, with all Applicable Laws.
10.7.    Knowledge. As used in this Article 10, “knowledge” shall mean actual knowledge.



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ARTICLE 11
INDEMNITY

11.1.    Indemnification of Lexicon. Sanofi shall indemnify Lexicon, its Affiliates and its and their respective directors, officers, employees and agents and defend and save each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) (collectively, “Losses”) in connection with any and all suits, investigations, claims or demands of Third Parties (collectively, “Third Party Claims”) arising from or occurring as a result of: (i) the breach by Sanofi of this Agreement or any Ancillary Agreement; (ii) the gross negligence or willful misconduct on the part of Sanofi or its Affiliates or its or their respective directors, officers, employees or agents in performing its or their obligations under this Agreement or any Ancillary Agreement; or (iii) the Exploitation by Sanofi or any of its Affiliates or Sublicensees of any Licensed Product or the Licensed Compound in the Territory, including Third Party Claims asserting product liability or intellectual property infringement. In the event that any Losses arise from (A) on the one hand, acts or omissions described in clauses (i) or (ii) of this Section 11.1 and (B) on the other hand, acts or omissions described in clauses (i) or (ii) of Section 11.2, each Party shall indemnify the other on a comparative fault basis to the extent its acts or omissions gave rise to such liability.
11.2.    Indemnification of Sanofi. Lexicon shall indemnify Sanofi, its Affiliates and its and their respective directors, officers, employees and agents and defend and save each of them harmless, from and against any and all Losses in connection with any and all Third Party Claims arising from or occurring as a result of: (i) the breach by Lexicon of this Agreement or any Ancillary Agreement; (ii) the gross negligence or willful misconduct on the part of Lexicon or its Affiliates or its or their respective directors, officers, employees or agents in performing its obligations under this Agreement or any Ancillary Agreement; or (iii) the Exploitation by Lexicon or any of its Affiliates of the Licensed Compound, Licensed Products or Terminated Products (a) anywhere in the world prior to the Effective Date or after the Term, or (b) in the Terminated Territory. In the event that any Losses arise from (A) on the one hand, acts or omissions described in clauses (i) or (ii) of this Section 11.2 and (B) on the other hand, acts or omissions described in clauses (i) or (ii) of Section 11.1, each Party shall indemnify the other on a comparative fault basis to the extent its acts or omissions gave rise to such liability.
11.3.    Indemnification Procedures.
11.3.1.    Notice of Claim. All indemnification claims in respect of a Party, its Affiliates or its or their respective directors, officers, employees and agents shall be made solely by such Party to this Agreement (the “Indemnified Party”). The Indemnified Party shall give the indemnifying Party prompt written notice (an “Indemnification Claim Notice”) of any Losses or discovery of fact upon which such indemnified Party intends to base a request for indemnification under this ARTICLE 11, but in no event shall the indemnifying Party be liable for any Losses that result from any delay in providing such notice. Each Indemnification Claim Notice must contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss is known at such time). The Indemnified Party shall furnish promptly to the indemnifying Party copies of all papers and official documents received in respect of any Losses and Third Party Claims.
11.3.2. Control of Defense. At its option, the indemnifying Party may assume the defense of any Third Party Claim by giving written notice to the Indemnified Party within [**] after the indemnifying Party’s receipt of an Indemnification Claim Notice. The assumption of the defense of a Third Party Claim by the indemnifying Party shall not be construed as an acknowledgment that the

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indemnifying Party is liable to indemnify the Indemnified Party in respect of the Third Party Claim, nor shall it constitute a waiver by the indemnifying Party of any defenses it may assert against the Indemnified Party’s claim for indemnification. Upon assuming the defense of a Third Party Claim, the indemnifying Party may appoint as lead counsel in the defense of the Third Party Claim any legal counsel selected by the indemnifying Party. In the event the indemnifying Party assumes the defense of a Third Party Claim, the Indemnified Party shall immediately deliver to the indemnifying Party all original notices and documents (including court papers) received by the Indemnified Party in connection with the Third Party Claim. Should the indemnifying Party assume the defense of a Third Party Claim, except as provided in Section 11.3.3, the indemnifying Party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party in connection with the analysis, defense or settlement of the Third Party Claim unless specifically requested in writing by the indemnifying Party. In the event that it is ultimately determined that the indemnifying Party is not obligated to indemnify, defend or hold harmless the Indemnified Party from and against the Third Party Claim, the Indemnified Party shall reimburse the indemnifying Party for any and all costs and expenses (including attorneys’ fees and costs of suit) and any Losses incurred by the indemnifying Party in its defense of the Third Party Claim.
11.3.3.    Right to Participate in Defense. Any Indemnified Party shall be entitled to participate in, but not control, the defense of such Third Party Claim and to employ counsel of its choice for such purpose; provided, however, that such employment shall be at the Indemnified Party’s sole cost and expense unless (i) the employment thereof has been specifically authorized in writing by the indemnifying Party in writing, (ii) the indemnifying Party has failed to assume the defense and employ counsel in accordance with Section 11.3.2 (in which case the Indemnified Party shall control the defense) or (iii) the interests of the Indemnified Party and the indemnifying Party with respect to such Third Party Claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under Applicable Law, ethical rules or equitable principles.
11.3.4.    Settlement. With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim and that shall not result in any indemnitee’s becoming subject to injunctive or other relief and as to which the indemnifying Party shall have acknowledged in writing the obligation to indemnify the indemnitees hereunder, the indemnifying Party shall have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such terms as the indemnifying Party, in its sole discretion, shall deem appropriate. With respect to all other Losses in connection with Third Party Claims, where the indemnifying Party has assumed the defense of the Third Party Claim in accordance with Section 11.3.2, the indemnifying Party shall have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss; provided it obtains the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld, conditioned or delayed). If the indemnifying Party does not assume and conduct the defense of a Third Party Claim as provided above, the Indemnified Party may defend against such Third Party Claim; provided that the Indemnified Party shall not settle any Third Party Claim without the prior written consent of the indemnifying Party (which consent shall not be unreasonably withheld, conditioned or delayed).
11.3.5.    Cooperation. Regardless of whether the indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall and shall cause each indemnitee to, cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours afforded to the indemnifying Party to, and reasonable retention by the

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Indemnified Party of, records and information that are reasonably relevant to such Third Party Claim and making Indemnified Parties and other employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder and the indemnifying Party shall reimburse the Indemnified Party for all its reasonable and verifiable out-of-pocket expenses in connection therewith.
11.3.6.    Expenses. Except as provided above, the costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any claim shall be reimbursed on a Calendar Quarter basis by the indemnifying Party, without prejudice to the indemnifying Party’s right to contest the Indemnified Party’s right to indemnification and subject to refund in the event the indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party.
11.4.    Special, Indirect and Other Losses. EXCEPT (I) IN THE EVENT OF THE WILLFUL MISCONDUCT OR FRAUD OF A PARTY OR A PARTY’S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 9 AND (II) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE 11, NEITHER PARTY NOR ANY OF ITS AFFILIATES OR SUBLICENSEES SHALL BE LIABLE IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL OR PUNITIVE DAMAGES OR FOR LOSS OF PROFITS SUFFERED BY THE OTHER PARTY.
11.5.    Insurance. Each Party shall have and maintain such types and amounts of insurance covering its Exploitation of the Licensed Compound and Licensed Products as is (i) normal and customary in the pharmaceutical industry generally for parties similarly situated (it being recognized that Lexicon will not be selling Licensed Products under this Agreement and, accordingly, will not carry the level of insurance that is normal and customary for commercializing parties) and (ii) otherwise required by Applicable Law. Upon request by the other Party, each Party shall provide to the other Party evidence of its insurance coverage. The insurance policies shall be under an occurrence form, but if only a claims-made form is available to a Party, then such Party shall continue to maintain such insurance after the expiration or termination of this Agreement in its entirety for a period of [**]. Notwithstanding the foregoing, Sanofi may self-insure in whole or in party the insurance requirements described above.
ARTICLE 12
HSR FILINGS; TERM AND TERMINATION

12.1.    HSR Filings The Parties shall each, as promptly as practicable after the Execution Date, file or cause to be filed with the U.S. Federal Trade Commission and the U.S. Department of Justice any notifications required to be filed under the HSR Act (the “HSR Filings”) with respect to the transactions contemplated hereby; provided that the Parties shall each make the HSR Filing within [**] after the Execution Date. The Parties shall use their reasonable best efforts to respond promptly to any requests for additional information made by such agencies, and to cause the waiting period (and any extension thereof) under the HSR Act to terminate or expire at the earliest possible date after the date of filing, including by requesting early termination of the waiting period. Each Party is responsible for the costs and expenses of its own legal and other advice in preparing its HSR Filing; and Sanofi shall be responsible for paying the filing fee required under the HSR Act. Notwithstanding anything in this Agreement to the contrary, this Agreement (other than this Article 12 and Section 10.3, which are binding and effective as of the Execution Date) shall become effective (unless terminated prior to such date) [**]

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after the expiration or earlier termination of the waiting period (or any extension thereof) under the HSR (the date that is [**] after such expiration or earlier termination, the “Effective Date”). Subject to the foregoing sentence, upon the Effective Date the full Agreement and all its terms and provisions shall be automatically effective and binding on both Parties. If, on the [**] after the date of filing under the HSR Act the waiting period (and any extension thereof) required thereunder has not expired or been terminated, either Party shall have the right, on written notice to the other Party, to terminate this Agreement, and upon receipt of such notice by such other Party, this Agreement shall be null and void and have no further force and effect.
12.2.    Term and Expiration. The term of this Agreement shall become effective as of the Effective Date and, unless earlier terminated in accordance herewith, shall continue in force and effect until the date of expiration of the last Royalty Term for the last Licensed Product (such period, the “Term”). Following the expiration of the Royalty Term for a Licensed Product in a country or region (but not on any earlier termination thereof), the grants in Section 2.1 shall become exclusive, fully-paid, royalty-free, perpetual and irrevocable for such Licensed Product in such country or region. For clarity, upon the expiration of the Term (but not on any earlier termination thereof), the grants in Section 2.1 shall become fully-paid, royalty-free, perpetual and irrevocable in their entirety.
12.3.    Termination.
12.3.1.    Material Breach. In the event that either Party (the “Breaching Party”) shall be in material breach of this Agreement, in addition to any other right and remedy the other Party (the “Non-Breaching Party”) may have, the Non-Breaching Party may terminate this Agreement in its entirety or on a country-by-country basis with respect to the country affected by such breach by providing [**] ([**] in the case of a breach of a payment obligation) (the “Notice Period”) prior written notice (the “Material Breach Notice”) to the Breaching Party and specifying the breach and its claim of right to terminate; provided that (i) the termination shall not become effective at the end of the Notice Period if the Breaching Party cures the breach specified in the Material Breach Notice during the Notice Period (or, if such default is not a breach of a payment obligation and cannot be cured within the Notice Period, if the Breaching Party commences actions to cure such breach within the Notice Period and thereafter diligently continues such actions), (ii) with respect to any alleged breach by a Party of its diligence obligations set forth herein (with respect to Sanofi, in any of Sections 3.1.2(iii), 3.1.4, 3.2.1(vii) and 4.2, and with respect to Lexicon, in any of Sections 3.1.2(iii), 3.1.4 and 4.2), the Non-Breaching Party shall first provide written notice thereof to the Breaching Party and the Parties shall meet within [**] after delivery of such notice to the Breaching Party to discuss in good faith such alleged breach and the Breaching Party’s Development or Commercialization plans, as applicable, with respect to the applicable Licensed Product, which discussions shall be concluded before the Non-Breaching Party may issue any Material Breach Notice with respect to such alleged breach (for clarity, the Notice Period shall not commence prior to the conclusion of such good faith discussions and the subsequent issuance of a Material Breach Notice by the Non-Breaching Party) and (iii) if either Party initiates a dispute resolution procedure under Section 13.5.1 as permitted under this Agreement within [**] following the end of the Notice Period to resolve the dispute for which termination is being sought and is diligently pursuing such procedure, the cure period set forth in this Section 12.3.1 shall be tolled and the termination shall become effective only if such breach remains uncured for [**] after the final resolution of the dispute through such dispute resolution procedure.
12.3.2.    Additional Termination Rights.

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(i)    Prior to completion of the Core Development Plan for T2DM, Sanofi may terminate this Agreement on a country-by-country basis with respect to the affected country or region or on a Licensed Product-by-Licensed Product basis with respect to the affected Licensed Products upon [**] written notice if (a) [**] notifies Sanofi or Lexicon that there is a material safety issue regarding a given Licensed Product, the Licensed Products generally, or the entire class of SGLT1 or SGLT2 inhibitors, and recommends or requires that Sanofi or Lexicon cease the Development of the Licensed Product based on applicable risk-benefit profiles, (b) with respect to any Decision Point, Positive Results are not achieved in all material respects, as determined in accordance with Section 3.1.3 (a “Positive Results Failure”), (c) Sanofi’s Commercially Reasonable Efforts obligations hereunder do not require the completion of the Core Development Plan due to the occurrence of a Fundamental Event, or (d) the Exploitation of the LX4211 Product by Sanofi, its Affiliates or any of their Sublicensees infringes any Patent or any other intellectual property right of a Third Party in any Major Market in the Territory, such that Sanofi or any of its Affiliates or Sublicensees cannot Exploit the LX4211 Product in such country as contemplated hereunder without infringing the Patent of such Third Party, and Sanofi is not able to obtain a license to such Third Party Patent on commercially reasonable terms; provided that, termination pursuant to this clause (d) shall be limited to the country(-ies) in which such Third Party Patent would be infringed. If Sanofi is entitled to terminate this Agreement, either in its entirety or on a country-by-country basis or with respect to any Licensed Products, Sanofi shall have the right to cease conducting any further activities under this Agreement in connection with Development with respect to any Terminated Product or Terminated Territory (subject only to compliance with Applicable Laws and ethical obligations).
(ii)    At any time after completion of the Core Development Plan for T2DM, Sanofi may terminate this Agreement in its entirety or on a country-by-country or Licensed Product-by-Licensed Product basis, for any or no reason, upon (a) [**] prior written notice to Lexicon, with respect to any country in which the Parties are neither Developing nor Commercializing any Licensed Product, or (b) [**] prior written notice to Lexicon, with respect to all other countries.
(iii)    If Sanofi terminates this Agreement for any or no reason, whether under this Section 12.3.2 or under any other Section(s), or if Lexicon terminates this Agreement under Section 12.3.1, as to two or more Major Markets in the European Union, such termination shall constitute termination of this Agreement as to the entire European Union and thereupon the entire European Union shall become a Terminated Territory.
(iv)    If Sanofi terminates this Agreement for any or no reason, whether under this Section 12.3.2 or under any other Section(s), or if Lexicon terminates this Agreement under Section 12.3.1, as to the United States and the European Union, this Agreement shall also terminate as to all other countries and thereupon such other countries shall become Terminated Territories.
12.3.3.    Without limitation of the termination rights set forth above, within [**] after the Effective Date (the “Japan Decision Date”), Sanofi may terminate this Agreement with respect to Japan upon written notice to Lexicon. In the event that such notice is not delivered by such date, then Japan shall automatically be deemed to be a Major Market hereunder effective as of the Japan Decision Date.
12.3.4.    Termination for Insolvency. In the event that either Party (i) files for protection under bankruptcy or insolvency laws, (ii) makes an assignment for the benefit of creditors, (iii) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is not discharged within [**] after such filing, (iv) proposes a written agreement of composition or extension of

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its debts, (v) proposes or is a party to any dissolution or liquidation, (vi) files a petition under any bankruptcy or insolvency act or has any such petition filed against that is not discharged within [**] of the filing thereof or (vii) admits in writing its inability generally to meet its obligations as they fall due in the general course, then the other Party may terminate this Agreement in its entirety effective immediately upon written notice to such Party.
12.3.5.    Termination for Cessation of Development. If Sanofi ceases all actual Development and Commercialization of Licensed Products, whether or not such cessation is consistent with the exercise by Sanofi of Commercially Reasonable Efforts by Sanofi to Develop and Commercialize Licensed Products hereunder, Lexicon may terminate this Agreement upon [**] written notice to Sanofi, unless (a) Sanofi initiates a dispute resolution procedure under Section 13.5 to resolve any dispute as to whether Lexicon has the right to seek termination pursuant to this Section 12.3.5 and Sanofi is diligently pursuing such procedure, (b) the cessation of such activities results from a force majeure, Sanofi is using commercially reasonable efforts to remedy its inability to perform in accordance with Section 13.1, and such force majeure has not continued for longer than [**] or (c) the cessation of such activities constitutes a material breach under Section 12.3.1 and Sanofi is diligently pursuing an action to cure such breach for the cure period, and is otherwise following the process, set forth in Section 12.3.1.
12.3.6.    Termination for Failure to Obtain HSR Clearance. This Agreement may be terminated by either Party as provided in Section 12.1.
12.4.    Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by Sanofi or Lexicon are and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that the Parties, as licensees of such rights under this Agreement, shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against either Party under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, the Party hereto that is not a Party to such proceeding shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, which, if not already in the non-subject Party’s possession, shall be promptly delivered to it (i) upon any such commencement of a bankruptcy proceeding upon the non-subject Party’s written request therefor, unless the Party subject to such proceeding elects to continue to perform all of its obligations under this Agreement or (ii) if not delivered under clause (i) above, following the rejection of this Agreement by or on behalf of the Party subject to such proceeding upon written request therefor by the non-subject Party.
12.5.    Consequences of Termination.
12.5.1.    In the case of a termination of this Agreement in its entirety or with respect to one or more countries or Licensed Products for any reason other than Section 12.3.6 (Termination for Failure to Obtain HSR Clearance), the remainder of this Section 12.5.1 shall apply, but solely with respect to the Terminated Territory or the Terminated Product(s), as applicable:
(i)    all rights and licenses granted by either Party hereunder shall immediately terminate with respect to the Terminated Territory or Terminated Product(s), as applicable;

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(ii)    Sanofi shall, and hereby does, grant to Lexicon a [**] nonexclusive license under any Sanofi Patents, Sanofi Know-How conceived, reduced to practice or otherwise made under the Development Plan or in connection with the Development or Manufacture of the Licensed Products by Sanofi or any of its Affiliates or its or their Sublicensees, or incorporated by Sanofi or any of its Affiliates or its or their Sublicensees into the Reversion Product as of the effective date of termination of this Agreement for the Exploitation of Licensed Products hereunder to the extent necessary or useful in order to Exploit the Reversion Products in the Field in the Terminated Territory; provided, however, that, (a) such license grant shall not include any rights with respect to the composition-of-matter of active ingredients in Combination Products that are not Licensed Compounds and (b) in the case of intellectual property in-licensed from Third Parties, the foregoing license grant shall apply to such Third Party intellectual property solely to the extent Sanofi is permitted to grant such license and any financial obligations with respect thereto are passed-through to Lexicon;
(iii)    if Sanofi [**], then Lexicon shall [**]; at Lexicon’s written request and cost, Sanofi shall (a) provide to Lexicon a copy of any and all material documentation and data (including Study Data not in the possession of Lexicon) Controlled by Sanofi in tangible form at the time of termination of the Agreement that has been generated with respect to the Reversion Products and is necessary or useful to enable Lexicon to continue Development and Commercialization of the Reversion Products (collectively, the “Sanofi Product Data”), and Lexicon may use such Sanofi Product Data at its discretion on a non-exclusive basis, but only to the extent necessary to enable Lexicon to continue Development of and to Commercialize Reversion Products, and (b) promptly assign and transfer to Lexicon any and all Product Trademarks and Regulatory Approvals obtained for the Reversion Products as well as any and all Regulatory Documentation for the Reversion Products; provided that [**]. In the event [**], Lexicon shall [**] within [**] after the end of each calendar quarter in a manner [**].
(iv)    at Lexicon’s request, Lexicon shall assume control of all clinical studies involving Licensed Products being conducted by Sanofi as of the effective date of termination; provided that, at Lexicon’s request, except in the cases of terminations by Sanofi pursuant to Section 12.3.1 (i.e., for Lexicon’s material breach) or 12.3.4 (i.e., for Lexicon’s insolvency), Sanofi shall remain obligated to continue to fund, to the extent of Sanofi’s funding obligations under this Agreement, the costs of such clinical studies then being conducted by Sanofi for Development Costs incurred [**] after the effective date of termination;
(v)    at Lexicon’s request, Sanofi shall sell and transfer to Lexicon any or all of Sanofi’s then remaining inventory of Terminated Products at Sanofi’s Manufacturing Cost therefor;
(vi)    at Lexicon’s request, to the extent Sanofi (or an Affiliate of Sanofi) is Manufacturing (on its own or through any Third Party contract manufacturer) any Terminated Product, continue to manufacture and supply such Terminated Product to Lexicon under a supply agreement mutually agreed upon by the Parties, for a period up to [**], until Manufacturing has been transitioned to Lexicon hereunder. In such case, Sanofi shall be obligated to supply quantities of such Terminated Products sufficient to satisfy Lexicon's requirements under a manufacturing transfer and transition plan to be negotiated by the Parties in good faith so that Lexicon can assume all Development and Commercialization activities with regard to such Terminated Products. Sanofi will supply such quantities of Terminated Products at Sanofi's Manufacturing Cost [**];
(vii)    at Lexicon’ request, assign or cause the assignment to Lexicon of any and all applicable Third Party manufacturing and supply agreements specifically relating to Terminated Products,

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to the extent Sanofi or its Affiliate is permitted to assign such agreement thereunder, or, if requested by Lexicon, facilitate discussions between Lexicon and the applicable Third Party manufacturer with respect to a transition of the applicable manufacturing and supply relationship to Lexicon; and
(viii)    at Lexicon’s request as to any Joint Patent, (A) Lexicon shall become the prosecuting Party with respect to such Joint Patent under Section 8.3.3, in which event Sanofi shall have the rights allocated to Lexicon thereunder, (B) Lexicon shall be entitled to take the actions set forth in Section 8.3.8 with respect to such Joint Patent, and (C) Lexicon shall have the first right to prosecute any Infringement of such Joint Patent under Section 8.5.2, in which event Sanofi shall have the rights allocated to Lexicon thereunder.
12.6.    Remedies. Except as otherwise expressly provided herein, termination of this Agreement (either in its entirety or with respect to one (1) or more country(ies)) in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity.
12.7.    Accrued Rights; Surviving Obligations.
12.7.1.    Termination or expiration of this Agreement (either in its entirety or with respect to one (1) or more country(ies)) for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration, subject to Section 7.2.3. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement.
12.7.2.    Without limiting the foregoing, Section 2.1 (Grants to Sanofi) (for clarity, subject to Section 12.2 and with a right to sublicense for all purposes without consent of Lexicon), Section 3.1.2(v)(4) (Quality) (second sentence only) (to the extent and for so long as required by Applicable Law), Section 3.1.6 (Development Records), Section 3.2.1(ii) (Regulatory Approvals), Section 3.2.3 (Recalls, Suspensions or Withdrawals), Section 3.2.4 (Global Safety Database) (third sentence only), Section 4.1 (In General) (but deleting the last clause of such section regarding (co-)promotion), Section 4.4 (Booking of Sales; Distribution), Section 7.5 (Royalty Payments and Reports) (with respect to any final payment for royalties on Net Sales occurring during the Royalty Term for the applicable country, as calculated under Section 7.3), Section 7.7 (Commercialization Costs and Medical Affairs Costs) (as applied to a final accounting of Commercialization Costs and Medical Affairs Costs incurred during the Term that are required to be shared by the Parties), Section 7.9 (Mode of Payment) (with respect to any payment due after the Term), Section 7.11 (Taxes) (with respect to any payment due after the Term), Section 7.12 (Interest on Late Payments), Section 7.13 (Financial Records) (for the period of time set forth herein, including with respect to any payment due after the Term), Section 7.14 (Audit Procedures) (with respect to any books and records maintained pursuant to Section 7.13), Section 7.14 (Audit Procedures), Section 8.1 (Ownership of Intellectual Property) (except Section 8.1.4 (Assignment Obligation)), Section 8.2 (Trademarks and Domain Names), Section 8.9 (Product Trademarks), Section 10.5 (Disclaimer of Warranties), Section 12.2 (Term and Expiration) (second sentence and third sentence only), Section 12.4 (Rights in Bankruptcy), Section 12.6 (Remedies), this Section 12.7 (Accrued Rights; Surviving Obligations), Section 13.1 (Force Majeure) (with respect to post-expiration obligations), Section 13.2 (Export Control), Section 13.3.1 (Assignment) (with respect to surviving rights and obligations), Section 13.4 (Severability), Section 13.5 (Dispute Resolution), Section 13.6 (Governing Law, Jurisdiction, Venue and Service), Section 13.7 (Notices), Section 13.8 (Entire Agreement; Amendments) (the first sentence, the second sentence, and only with respect to surviving provisions, the third sentence), Section 13.9 (English Language), Section 13.10 (Equitable Relief), Section 13.11 (Waiver and Non-Exclusion of

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Remedies), Section 13.12 (No Benefit to Third Parties), Section 13.13 (Further Assurances) (with respect to surviving rights and obligations), Section 13.14 (Performance by Affiliates), Section 13.15 (Relationship of the Parties), Section 13.16 (References), and Section 13.17 (Construction), and Article 1 (Definitions), Article 9 (Confidentiality), and Article 11 (Indemnity) of this Agreement shall survive the expiration of this Agreement for any reason.
12.7.3.    Without limiting Section 12.7.1, Section 3.1.2(v)(4) (Quality) (second sentence only) (to the extent and for so long as required by Applicable Law), Section 3.1.6 (Development Records), Section 7.5 (Royalty Payments and Reports) (with respect to any payment of royalties due after the Term), Section 7.6 (Development Costs) (as applied to a final accounting for Development Costs incurred during the Term that are required to be shared by the Parties), Section 7.7 (Commercialization Costs and Medical Affairs Costs) (as applied to a final accounting of Commercialization Costs and Medical Affairs Costs incurred during the Term that are required to be shared by the Parties), Section 7.8 (Calculation of T1DM Net Sales) (with respect to any royalties due after the Term), Section 7.9 (Mode of Payment) (with respect to any payment due after the Term), Section 7.11 (Taxes) (with respect to any payment due after the Term), Section 7.12 (Interest on Late Payments), Section 7.13 (Financial Records) (for the period of time set forth herein, including with respect to any payment due after the Term), Section 7.14 (Audit Procedures) (with respect to any books and records maintained pursuant to Section 7.13), Section 8.1 (Ownership of Intellectual Property) (except Section 8.1.4 (Assignment Obligation)), Section 8.3.3 (Patent Prosecution and Maintenance of the Joint Patents) (subject to Section 12.5.1(viii)), Section 8.3.4 (Cooperation) (solely as relating to the Joint Patents), Section 8.3.6 (Common Ownership Under Joint Research Agreements) (solely with respect to the Joint Patents), Section 8.3.8 (UPC Opt-Out and Opt-In) (solely as relating to the Joint Patents) (subject to Section 12.5.1(viii)), Section 8.4.1(ii) (Challenges by Third Parties, Joint Patents), Section 8.4.2(ii) (Challenges by a Party, Joint Patents), Section 8.5 (Enforcement of Patents) (solely with respect to the Joint Patents) (subject to Section 12.5.1(viii)), Section 8.6 (Invalidity or Unenforceability Defenses or Actions) (solely with respect to the Joint Patents), Section 10.5 (Disclaimer of Warranties), Section 12.4 (Rights in Bankruptcy), Section 12.5 (Consequences of Termination), Section 12.6 (Remedies), this Section 12.7 (Accrued Rights; Surviving Obligations), Section 13.1 (Force Majeure) (with respect to post-termination obligations), Section 13.2 (Export Control), Section 13.3.1 (Assignment) (with respect to surviving rights and obligations), Section 13.4 (Severability), Section 13.5 (Dispute Resolution), Section 13.6 (Governing Law, Jurisdiction, Venue and Service), Section 13.7 (Notices), Section 13.8 (Entire Agreement; Amendments) (the first sentence, the second sentence, and only with respect to surviving provisions, the third sentence), Section 13.9 (English Language), Section 13.10 (Equitable Relief), Section 13.11 (Waiver and Non-Exclusion of Remedies), Section 13.12 (No Benefit to Third Parties), Section 13.13 (Further Assurances) (with respect to surviving rights and obligations), Section 13.14 (Performance by Affiliates), Section 13.15 (Relationship of the Parties), Section 13.16 (References), and Section 13.17 (Construction), and Article 1 (Definitions), Article 9 (Confidentiality), and Article 11 (Indemnity) of this Agreement shall survive the termination of this Agreement for any reason. If this Agreement is terminated with respect to the Terminated Territory or a Licensed Product but not in its entirety, then following such termination the foregoing provisions of this Agreement shall remain in effect with respect to the Terminated Territory or the Terminated Product(s) (to the extent they would survive and apply in the event the Agreement expires or is terminated in its entirety) and all provisions not surviving in accordance with the foregoing shall terminate upon termination of this Agreement with respect to the Terminated Territory or Terminated Product and be of no further force and effect (and for the avoidance of doubt all provisions of this Agreement shall remain in effect with respect to all countries in the Territory and all Licensed Products other than the Terminated Territory and Terminated Products).

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ARTICLE 13
MISCELLANEOUS

13.1.    Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement (other than an obligation to make payments) when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes, lockouts or other labor disturbances (whether involving the workforce of the non-performing Party or of any other Person), acts of God or acts, omissions or delays in acting by any governmental authority (except to the extent such omission or delay results from the breach by the non-performing Party or any of its Affiliates of its or their Development, Manufacturing or Commercialization obligations or any other term or condition of this Agreement). The non-performing Party shall notify the other Party of such force majeure within [**] after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration and any action being taken to avoid or minimize its effect. The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use commercially reasonable efforts to remedy its inability to perform. In the event that the force majeure continues for more than [**], the Party not affected by such force majeure shall have the right, at its sole election and expense, and without limitation to any other right or remedy available to such Party, to assume and complete some or all of the activities that the non-performing Party is not performing as a result of such force majeure.
13.2.    Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other governmental entity in accordance with Applicable Law.
13.3.    Assignment and Change of Control.
13.3.1.    Neither Party may assign its rights or, except as expressly permitted hereunder, delegate its obligations under this Agreement, whether by operation of law or otherwise, in whole or in part, without the prior written consent of the other Party, except that each Party shall have the right, without such consent, to assign any or all of its rights and delegate any or all of its obligations hereunder to any of its Affiliates or its or their Sublicensees or to any successor in interest (whether by merger, acquisition, asset purchase or otherwise) to all or substantially all of its diabetes business; provided that the assigning or delegating Party shall provide written notice to the other Party within [**] after such assignment or delegation and shall remain primarily liable for the performance of its assignee or delegate. Any permitted successor of a Party or any permitted assignee of all of a Party’s rights under this Agreement that has also assumed all of such Party’s obligations hereunder in writing shall, upon any such succession or assignment and assumption, be deemed to be a party to this Agreement as though named herein in substitution for the assigning Party, whereupon the assigning Party shall cease to be a party to this Agreement and shall cease to have any rights or obligations under this Agreement. All validly assigned rights of a Party shall inure to the benefit of and be enforceable by, and all validly delegated obligations of such Party shall be binding on and be enforceable against, the permitted successors and

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assigns of such Party. Any attempted assignment or delegation in violation of this Section 13.3.1 shall be void and of no effect.
13.3.2.    No later than [**] following the earlier of the first public announcement of the execution of any transaction with respect to a Change of Control of Lexicon or the closing date of such a transaction, Lexicon shall notify Sanofi in writing and identify the counterparty to the transaction (the “Third Party Acquirer”). In such a case, effective as of the later of (a) a notice from Sanofi pursuant to this Section 13.3.2 and (b) the closing of such a transaction, Sanofi shall have the following rights, except in the case of a Change of Control transaction in which the Third Party Acquirer is a Non-Competitive Acquirer:
(i)    Sanofi may, in its sole discretion and by written notice to Lexicon, require Lexicon and the Third Party Acquirer and its Affiliates (“Third Party Acquirer Family”) to adopt reasonable procedures, including firewalls, to prevent disclosure of Confidential Information of Sanofi and its Affiliates (including the Sanofi Know-How) to the Third Party Acquirer Family (other than Lexicon and its Affiliates) and to prevent the Third Party Acquirer Family (other than Lexicon and its Affiliates) from involvement in the Development, Commercialization and Manufacture of the Licensed Products;
(ii)    Sanofi may, in its sole discretion, assume and complete any Development activities with respect to T1DM on the Licensed Compounds. If Sanofi so elects to assume and complete any of the Development activities under the Development Plan with respect to such Licensed Compound, to the extent reasonably requested by Sanofi in writing, Lexicon shall cooperate in facilitating the orderly transfer of such Development activities and ensure that Sanofi obtains the material benefits of any or all Third Party agreements relating to such Development activities, in conformity with any Applicable Law.
(iii)    Sanofi may, in its sole discretion and by written notice to Lexicon, disband the JSC (in which case the DRC and MSC shall also be disbanded) and, for clarity, Section 5.5.6 shall apply. In such a case, neither Lexicon nor any of its Affiliates shall have the right to receive Information and Inventions from Sanofi (except for reports provided pursuant to Sections 3.1.7, 4.10 and 7.5) or provide input with respect to the Exploitation of any Licensed Products from and after the date of such Change in Control (except where such input is required by Applicable Law). Notwithstanding the foregoing, this clause (iii) shall not deprive Lexicon of (A) its right to participate in discussions with Sanofi regarding the Development activities conducted pursuant to the Development Plan, Manufacturing and (Co-)Promotion, in each case, to the extent reasonably necessary in order for Lexicon to perform its obligations hereunder or under the applicable Ancillary Agreement or (B) its right to exercise a Lexicon Consent Right; or
(iv)    Sanofi may, upon [**] prior written notice to Lexicon given by Sanofi not later than [**] following the Change of Control transaction, terminate the (Co-)Promotion Agreement. If Sanofi exercises its termination right under this Section 13.3.2(iii) after the commencement of (Co-)Promotion activities under the (Co-)Promotion Agreement, then Sanofi agrees to reimburse Lexicon for its reasonable wind-down costs as set forth in the (Co-)Promotion Agreement.
13.3.3.    In the case in which Lexicon is acquired by a Third Party Acquirer, the rights to Information and Inventions controlled by the Third Party Acquirer Family shall, subject to Section 13.3.2(i), be automatically excluded from the rights licensed or granted to the other Party under this Agreement unless and to the extent that Lexicon uses any such Information and Inventions in the

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conduct of the Development Plan or incorporates any such Information and Inventions into any Licensed Product.
13.4.    Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future law and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (i) such provision shall be fully severable, (ii) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (iii) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (iv) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties. To the fullest extent permitted by Applicable Law, each Party hereby waives any provision of law that would render any provision hereof illegal, invalid or unenforceable in any respect.
13.5.    Dispute Resolution.
13.5.1.    Subject to Section 13.10, if a dispute arises (i) within the JSC with respect to any decision under the jurisdiction of the JSC that remains unresolved pursuant to Section 5.5.3 (a “JSC Dispute”) or (ii) between the Parties in connection with or relating to this Agreement or any Ancillary Agreement (collectively, (i) and (ii), a “Dispute”), then either Party shall have the right, upon notice to the other Party, to refer such Dispute to the Senior Officers for attempted resolution by good faith negotiations during the period of [**] following the date of such referral. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If such Senior Officers are unable to resolve any such JSC Dispute within such [**] period, Sanofi shall have the right to finally and definitively resolve any Dispute in good faith in a manner consistent with this Agreement unless (a) there is a Lexicon Consent Right with respect to the matter (in the case of clause (a), such Disputes shall be resolved only by the mutual written consent of the Parties), (b) the matter is outside the jurisdiction and authority of the JSC (including as set forth in Section 5.5.4), (c) the Dispute is a Legal Dispute, or (d) the subject matter of the Dispute is whether Positive Results have been achieved in all material respects with respect to any Decision Point (in the case of clause (d), such Dispute shall be resolved, if not resolved by negotiations by the Senior Officers in accordance with this Section 13.5.1 above, by binding arbitration pursuant to Section 13.5.2). With respect to any unresolved dispute as to a matter outside the jurisdiction and authority of the JSC or Legal Dispute, either Party shall be free to institute binding arbitration in accordance with Section 13.5.2 upon written notice to the other Party (an “Arbitration Notice”) and seek such remedies as may be available. Notwithstanding anything in this Agreement to the contrary, either Party shall be entitled to institute litigation in accordance with Section 13.6 immediately with respect to any dispute as to a matter outside the jurisdiction and authority of the JSC or Legal Dispute if litigation is necessary to prevent irreparable harm to that Party.
13.5.2.    Upon receipt of an Arbitration Notice by a Party, the applicable Dispute shall be resolved by final and binding arbitration before a panel of three (3) arbitrators with relevant biopharmaceutical industry experience (the “Arbitrators”), who shall be selected in accordance with the Comprehensive Arbitration Rules and Procedures then in effect and the Expedited Procedures contained therein, as modified in this paragraph (the “Rules”). Such arbitration shall be administered by JAMS (or any successor entity thereto) and in accordance with the Rules, except (i) to the extent such rules are inconsistent with this Section 13.5.2, in which case, this Section 13.5.2 shall control (including with regard to any limitations of liability or forms of relief), and (ii) three (3) discovery depositions may be

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conducted per side. The JAMS Expedited Procedures shall be modified to delete paragraphs 16.2(b) (Limitation on Document Requests) and 16.2(e) (Limitation on Expert Depositions) of such procedures as in effect on the Effective Date, and the timelines shall be modified to provide that (x) the discovery cutoff for percipient discovery shall not exceed [**] after the preliminary conference, (y) the discovery cutoff for expert discovery shall not exceed [**] after the preliminary conference, and (z) the hearing shall commence within [**] after the cutoff for expert discovery. The proceedings and decisions of the arbitrators shall be confidential, final and binding on the Parties, and judgment upon the award of such arbitrator may be entered in any court having jurisdiction thereof. The arbitration shall be conducted in English and held in New York, New York. The Arbitrator shall, within [**] after the conclusion of the arbitration hearing, issue a written award and statement of decision describing the essential findings and conclusions on which the award is based, including the calculation of any damages awarded. The decision or award rendered by the Arbitrator shall be final and non-appealable, and judgment may be entered upon it in accordance with Applicable Law in the State of New York or any other court of competent jurisdiction. The Arbitrator shall be authorized to award compensatory damages, but shall not be authorized to reform, modify or materially change this Agreement or any Ancillary Agreement. Each Party shall bear its own counsel fees, costs, and disbursements arising out of the arbitration described in this Section 13.5.2, and shall pay an equal share of the fees and costs of the Arbitrator and all other general fees related to the arbitration; provided, however, the Arbitrator shall be authorized to determine whether a Party is the prevailing Party, and if so, to award to that prevailing Party reimbursement for its reasonable counsel fees, costs and disbursements (including expert witness fees and expenses, photocopy charges, or travel expenses), or the fees and costs of the Arbitrator. Unless the Parties otherwise agree in writing, during the period of time that any arbitration proceeding is pending under this Agreement, the Parties shall continue to comply with all those terms and provisions of this Agreement that are not the subject of the pending arbitration proceeding. Nothing contained in this Agreement shall deny any Party the right to seek injunctive or other equitable relief from a court of competent jurisdiction in the context of a bona fide emergency or prospective irreparable harm, and such an action may be filed and maintained notwithstanding any ongoing arbitration proceeding. All arbitration proceedings and decisions of the Arbitrator under this Section 13.5.2 shall be deemed Confidential Information of both Parties under Article 9. The Parties intend that each award rendered by an Arbitrator hereunder shall be entitled to recognition and enforcement under the United Nations Convention on the Recognition and Enforcement of Arbitral Awards (New York, 1958).
13.6.    Governing Law, Jurisdiction, Venue and Service.
13.6.1.    Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction. The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.
13.6.2.    Jurisdiction. Subject to Section 13.5 and Section 13.10, the Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of the State of New York for any action arising out of or relating to this Agreement and agree not to commence any action, suit or proceeding (other than appeals and enforcements of awards therefrom) related thereto except in such courts. The Parties irrevocably and unconditionally waive their right to a jury trial in any such action.
13.6.3.    Venue. Subject to Section 13.5 and Section 13.10, the Parties further hereby irrevocably and unconditionally waive any objection to the laying of venue of any action arising out of or

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relating to this Agreement in the courts of the State of New York and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action brought in any such court has been brought in an inconvenient forum.
13.6.4.    Service. Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 13.7.2 shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any such court.
13.7.    Notices.
13.7.1.    Notice Requirements. Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 13.7.2 or to such other address as the Party to whom notice is to be given may have provided to the other Party in accordance with this Section 13.7.1. Such notice shall be deemed to have been given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed) or on the second Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. Any notice delivered by facsimile shall be confirmed by a hard copy delivered as soon as practicable thereafter. This Section 13.7.1 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement.
13.7.2.    Address for Notice.
If to Sanofi, to:
54 Rue La Boétie, 75008
Paris, France
Attention: Pascale Witz
with copies (which shall not constitute notice) to:

54 Rue La Boétie, 75008
Paris, France
Tel. +331 5377 4664
Attention: VP, Legal Operations
Facsimile: +331 5377 4453
Covington & Burling LLP
One Front Street
San Francisco, California 94111
USA
Attention: Amy Toro
Facsimile: +1 (415) 955-6586

86

Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

If to Lexicon, to:
Lexicon Pharmaceuticals, Inc.
8800 Technology Forest Place
The Woodlands, Texas 77381
USA
Attention: President
with copies (which shall not constitute notice) to:
Lexicon Pharmaceuticals, Inc.
8800 Technology Forest Place
The Woodlands, Texas 77381
USA
Attention: General Counsel
and
WilmerHale LLP
60 State Street
Boston, Massachusetts 02109
USA
Attention: Steven D. Barrett, Esq.
Facsimile: +1 (617) 526-5000
13.8.    Entire Agreement; Amendments. This Agreement, together with the Schedules attached hereto and any Ancillary Agreements, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises and representations, whether written or oral, with respect thereto, including that certain Confidentiality Agreement, dated as of October 12, 2015, are superseded hereby. Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement. No amendment, modification, release or discharge shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties. In the event of any inconsistencies between this Agreement and any schedules or other attachments hereto, the terms of this Agreement shall control.
13.9.    English Language. This Agreement shall be written and executed in and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.
13.10.    Equitable Relief. Each Party acknowledges and agrees that the restrictions set forth in Section 2.6 and ARTICLE 9 and the requirements of ARTICLE 8 are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into this Agreement in the absence of such restrictions and that any breach or threatened breach of any provision of such Sections and Articles may result in irreparable injury to such other Party for which there will be no adequate remedy at law. In the event of a breach or threatened breach of any provision of such Sections and Articles, the non-breaching Party shall be authorized and entitled to seek from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, specific performance and an equitable accounting of all earnings, profits and other benefits arising from such breach, which rights shall be cumulative and in addition to any other rights or remedies to which such non-breaching Party may be

87

Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

entitled in law or equity. Both Parties agree to waive any requirement that the other (i) post a bond or other security as a condition for obtaining any such relief, or (ii) show irreparable harm, balancing of harms, consideration of the public interest or inadequacy of monetary damages as a remedy. Nothing in this Section 13.10 is intended or should be construed, to limit either Party’s right to equitable relief or any other remedy for a breach of any other provision of this Agreement.
13.11.    Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein.
13.12.    No Benefit to Third Parties. Except as provided in ARTICLE 11, the covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns and they shall not be construed as conferring any rights on any other Persons.
13.13.    Further Assurance. Each Party shall duly execute and deliver or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof or to better assure and confirm unto such other Party its rights and remedies under this Agreement.
13.14.    Performance by Affiliates. To the extent that this Agreement imposes obligations on Affiliates of a Party, such Party agrees to cause its Affiliates to perform such obligations.
13.15.    Relationship of the Parties. It is expressly agreed that Lexicon, on the one hand, and Sanofi, on the other hand, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Lexicon, on the one hand, nor Sanofi, on the other hand, shall have the authority to make any statements, representations or commitments of any kind, or to take any action that will be binding on the other, without the prior written consent of the other Party to do so. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such first Party.
13.16.    References. Unless otherwise specified, (i) references in this Agreement to any Article, Section or Schedule shall mean references to such Article, Section or Schedule of this Agreement, (ii) references in any Section to any clause are references to such clause of such Section and (iii) references to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently amended, replaced or supplemented from time to time, as so amended, replaced or supplemented and in effect at the relevant time of reference thereto.

88

Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

13.17.    Construction. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is used in the inclusive sense (and/or). Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The term “including,” “include,” or “includes” as used herein shall mean including, without limiting the generality of any description preceding such term. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against either Party hereto.
13.18.    Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may be executed by facsimile, PDF format via email or other electronically transmitted signatures and such signatures shall be deemed to bind each Party hereto as if they were original signatures.
13.19.    Non-Solicit. Commencing on the Effective Date and for as long as either Party is promoting any Licensed Product in the (Co-)Promotion Territory, neither Party shall, directly or indirectly, actively recruit or solicit any employee of the other Party with whom such Party has come into contact or interacted for the purposes of performing this Agreement, without the prior consent of the other Party. For purposes of this Section, “solicit” shall be deemed not to include: (i) circumstances where an employee of one Party or any of its Affiliates initially contacts the other Party or any of such Party’s Affiliates seeking employment; or (ii) general solicitations of employment not specifically targeted at such employees.
[SIGNATURE PAGE FOLLOWS.]



89

Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the date first written above.
SANOFI
 
 
 
 
 
 
 
By:
 
Name:
 
Title:
 
 
 
 
 
LEXICON PHARMACEUTICALS, INC.
 
 
 
 
 
 
 
By:
 
Name:
 
Title:
 


90

Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

Schedule 1.40
Corporate Names

Lexicon Pharmaceuticals, Inc.







Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

Schedule 1.68
FTE Rates

Development
Development - [**]
Discovery - [**]
The Development and Discovery FTE Rates are intended to include the following costs: The fully burdened cost of the professionals performing the activities, including allocated costs, but for clarity, not including clinical study materials.

Sales Force
Sales Force (Specialist) - [**]
For an employee sales representative in the Specialist sales force who carries only a Licensed Product, then the full FTE Rate for such employee may be included in Commercialization Costs.
For an employee sales representative in the Specialist sales force who is conducting primary details of the Licensed Product but the Licensed Product is not the only Licensed Product, then [**] of the full FTE Rate for such employee may be included in Commercialization Costs.
The Sales Force FTE Rate is intended to include the following costs: The fully burdened cost of sales representatives, including an allocation of regional and country sales force management cost, inclusive of out-of-pocket costs and other expenses for the employee providing the services, including travel costs, information systems and allocated costs, such as, for example, allocated overhead costs. Promotional materials (i.e., detail aids), including agency costs for development, are not included in these costs. Further detail will be included in the (Co-)Promotion Agreement.

MSL and Medical Affairs
MSL - [**]
Medical Affairs - [**]
The MSL and Medical Affairs FTE Rates are intended to include the following costs: The fully burdened cost of the MSLs and medical affairs professionals, inclusive of out-of-pocket costs and other expenses for the employee providing the activities, including travel costs and allocated costs, such as, for example, allocated overhead costs. Further detail will be included in the (Co-)Promotion Agreement.




Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

Schedule 1.106
LX2761 Description


[**]




Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

Schedule 1.111
LX4211 Description


Product Identification: LX4211

Chemical Name: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol

CAS Number: 1018899-04-1

Synonym(s): LP-802034

Formula Weight: 424.94

Molecular Weight: 424.94




Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.


Schedule 2.4

Transferred Materials

Documents in the dataroom as of the Execution Date

Material Lexicon Know-How newly available between the Execution Date and the Effective Date that satisfies the criteria set forth in sentence 2 of Section 2.4.1.




Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.


Schedule 3.1.2
Initial Development Plan

T1DM
List of On-going LX4211 Type 1 Studies -- Conducted by Lexicon
Study Number
Protocol Title
Pt Population
Study Design
# of Subjects Planned
Study Status
[**]
[**]
[**]
[**]
[**]
[**]

T2DM

Initial Phase 3 Development Plan for T2DM - conducted by Sanofi
 
Study Design
Background Therapy
(Rescue)
N
Total/
arm
Arms
Core Treatment period
Double-bl.
eGFR
mL/min/ 1.73 m2
Long-term Extension:
Double-blind
Comments
Related Decision Points
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]






Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

The Positive Results of studies [**] shall constitute Decision Points according to section 3.1.3 of the Agreement.

Costs in k$
 
2016
2017
2018
2019
2020
2021
2022
2023
Total
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
TOTAL Phase 3 T2DM Program
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]

Permitted Subcontracts for T2DM: [**]





Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

Schedule 3.1.7
Development Reporting
(i)
Filings and acceptance of filings for Regulatory Approval of the Licensed Products in any Major Market in the Territory
(ii)
Regulatory Approvals in the Major Markets in the Territory
(iii)
Initiation and completion of patient enrollment for clinical studies of Licensed Products
(iv)
Completion of clinical studies of Licensed Products and top line results thereof
(v)
Development milestone achievements
(vi)
Announcements of publications






Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.


Schedule 4.8.2
(Co-)Promotion Agreement Key Terms

-Promotional activities by both parties:
Target audience definition and quantification
Minimum sales force size [**]
Maximum Lexicon sales force size
Minimum and target number of calls per year per target
Commercialization plan definition
Lexicon may not [**]without the prior written consent of Sanofi.
Either party could decide to promote or engage in Commercialization activities outside of the T1DM Commercialization Plan subject to proper training, alignment with Commercialization Plan and compliance with Applicable Law. Those activities would be at such party's own expense and not subject to cost sharing.
Both parties' Specialist Efforts included in the T1D Commercialization Plan would be subject to the same ground rules (e.g., [**]).

-Medical affairs: Unless otherwise agreed, Lexicon employees will constitute a reasonable portion of Medical Affairs FTEs.
-Obligations of Lexicon:
Lexicon would provide no less than [**] FTEs and would have the option to provide up to [**] of Specialist Efforts included in the T1DM Commercialization Plan (and thus subject to cost sharing).
Lexicon would have the option to provide up to [**] of Medical Affairs FTEs included in the T1DM Commercialization Plan (and thus subject to cost sharing).
Delivery of [**]
Maximum number of products to be detailed during a call is [**]
Sales Force Training
Governance/Committees:
Coordination mechanism between Sanofi and Lexicon teams
Compliance, including compliance as required by any applicable corporate integrity agreement of Sanofi then in effect that is applicable to Lexicon as a result of its activities hereunder

-Other:
Specialty sales force on a non-exclusive basis (i.e., Sanofi may also promote to specialists, including mirroring).




Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.


Schedule 9.6
Press Release

[Attached]



Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

PRESS RELEASE


                        
Sanofi and Lexicon Pharmaceuticals to Collaborate on Sotagliflozin, an Investigational New Oral Medicine for People with Diabetes


Paris and The Woodlands, TX - November 6, 2015 - Sanofi (EURONEXT: SAN and NYSE: SNY) and Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) announced today that they have entered into a collaboration and license agreement for the development and commercialization of sotagliflozin, an investigational new oral dual inhibitor of sodium-glucose cotransporters 1 and 2 (SGLT-1 and SGLT-2), which could be a potential treatment option for people with diabetes.

“This agreement with Lexicon reinforces our commitment to helping people living with diabetes,” said Pascale Witz, Executive Vice President, Sanofi, who will lead the Global Diabetes and Cardiovascular Care Business Unit in the company's new organizational structure. “Adding sotagliflozin to our portfolio, which includes medicines at virtually every stage of the treatment pathway, highlights our focus on providing a large and diverse set of therapeutic options for people with this disease.”

The developmental medicine sotagliflozin (LX4211) is currently being studied in two pivotal Phase 3 trials in type 1 diabetes, which are expected to report top-line results during the second half of 2016. Phase 3 trials in type 2 diabetes are expected to begin in 2016. Sotagliflozin has previously shown encouraging results in exploratory (Phase 2) studies, including reduction of blood sugar (HbA1c), improvement in glycemic variability and reduced meal-time insulin dose compared with placebo in type 1 diabetics. Phase 2 studies exploring treatment in people with type 2 diabetes, including those with renal impairment, showed lowering of blood sugar (HbA1c), weight loss and blood pressure improvements. No increase in hypoglycemic events was seen with sotagliflozin compared to background therapy in the Phase 2 program. The adverse event profile in the Phase 2 program was similar to other products in this class and reflective of the urinary glucose excretion associated with sotagliflozin’s inhibition of SGLT-2.

These results indicate that sotagliflozin could have the potential to become an important option among oral anti-diabetic medicines and provide a strong rationale for the further investigation of this compound as a treatment for people with diabetes.

“Lexicon firmly believes in the potential of sotagliflozin for patients living with diabetes. It has been our strategy to focus our resources on the development of sotagliflozin for type 1 diabetes and to pursue a strategic partnership with respect to type 2 diabetes only if it would strengthen stakeholder value under a fully integrated diabetes program. We believe this arrangement with Sanofi achieves that objective,” said Lexicon President and Chief Executive Officer Lonnel Coats. “Sanofi's patient-centric focus in diabetes, and its rich history of innovation in diabetes, make it an exceedingly attractive partner which is well positioned to unlock the full potential of sotagliflozin for patients living with diabetes. Also consistent with our strategy, Lexicon will continue to lead the development of sotagliflozin for type 1 diabetes and have rights to participate in the commercialization of sotagliflozin for type 1 diabetes in the United States.”



Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.


Under the terms of the agreement, Lexicon will receive an upfront payment of $300 million and is eligible to receive development, regulatory and sales milestone payments of up to $1.4 billion. Lexicon is also entitled to tiered, escalating double digit percentage royalties on net sales of sotagliflozin.

Sanofi obtains an exclusive worldwide license to develop, manufacture and commercialize sotagliflozin. Lexicon will continue to be responsible for all clinical development activities relating to type 1 diabetes and will retain an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the United States. Sanofi will be responsible for all clinical development and commercialization activities of sotagliflozin for the treatment of type 2 diabetes worldwide and will be solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the United States. Lexicon will share in the funding of a portion of the planned type 2 diabetes development costs over the next three years, up to an aggregate of $100 million.
The agreement is subject to customary filing and review under the Hart-Scott-Rodino Antitrust Improvements Act.
The investigational agent described above is currently under clinical development and its safety and efficacy have not been evaluated by any regulatory authority.

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

About Lexicon
Lexicon is a fully integrated biopharmaceutical company that is applying a unique approach to gene science, based on Nobel Prize-winning technology, to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in oncology, diabetes and metabolism. For additional information please visit www.lexpharma.com.

Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's and Lexicon’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi and Lexicon, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, including the timing of clinical trials, the uncertain predictive nature of clinical trials with respect to subsequent clinical trials, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s and Lexicon’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, as well as those risks and uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi and with the SEC made by Lexicon, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F and in Lexicon’s annual report on Form 10-K for



Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

the year ended December 31, 2014. Other than as required by applicable law, Sanofi and Lexicon do not undertake any obligation to update or revise any forward-looking information or statements.





Contacts:
Sanofi
 
Media Relations 
Jack Cox
Tel.: + (33) 1 53 77 45 02
jack.cox@sanofi.com
Investor Relations 
Sébastien Martel
Tel.: + (33) 1 53 77 45 45
ir@sanofi.com
Global Diabetes Communications
U.S. Diabetes Communications
Philip McNamara
Tel.: +1 908 981 5497
philip.mcnamara@sanofi.com
Susan Brooks
Tel.: +1 908 981 6566
susan.brooks@sanofi.com
 
 
Lexicon Pharmaceuticals, Inc.
 
Media Relations 
Mariann Caprino
Tel.: +1 917 242 1087
m.caprino@togorun.com

Investor Relations 
Chas Schultz
Tel.: + 1 281 863 3421
cschultz@lexpharma.com






Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

Schedule 9.9
Form 8-K

[Attached]





Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.



UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

__________________

FORM 8-K
__________________

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):    November ___, 2015


Lexicon Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)


Delaware
000-30111
76-0474169
(State or other jurisdiction of
incorporation or organization)
(Commission File Number)
(I.R.S. Employer
Identification Number)


8800 Technology Forest Place
The Woodlands, Texas 77381
(Address of principal executive
offices and Zip Code)


(281) 863-3000
(Registrant’s telephone number,
including area code)


Check the appropriate box below if the Form 8‑K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
¨    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨    Soliciting material pursuant to Rule 14a‑12 under the Exchange Act (17 CFR 240.14a‑12)
¨    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d‑2(b))
¨    Pre-commencement communications pursuant to Rule 13e‑4(c) under the Exchange Act
(17 CFR 240.13e‑4(c))




Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.


Item 1.01
Entry into a Material Definitive Agreement.

On November ___, 2015, we entered into a Collaboration and License Agreement (the “Agreement”) with Sanofi for the worldwide development and commercialization of our diabetes drug candidate sotagliflozin.
Under the Agreement, we granted Sanofi an exclusive, worldwide, royalty-bearing right and license under our patent rights and know-how to develop, manufacture and commercialize sotagliflozin. Subject to specified exceptions, neither party may (a) perform clinical development activities relating to any other compound which inhibits sodium-glucose cotransporters type 1 or type 2 or (b) commercialize any such compounds in the United States, countries of the European Union and certain other specified countries, in each case during the royalty terms applicable in such countries. Among the specified exceptions is a right we retained to pursue the development of our LX2761 drug candidate, with respect to which we granted Sanofi certain rights of first negotiation specified in the Agreement.
Under the Agreement, Sanofi will pay us an upfront payment of $300 million. In addition, we are eligible to receive from Sanofi (a) up to an aggregate of $430 million upon the achievement of specified development and regulatory milestones and (b) up to an aggregate of $990 million upon the achievement of specified sales milestones. We are also entitled to tiered, escalating royalties ranging from low double digit percentages to forty percent of net sales of sotagliflozin, based on indication and territory, with royalties for the higher band of such range attributable to net sales for type 1 diabetes in the United States, and subject in each case to customary royalty reduction provisions. Royalties payable with respect to net sales of sotagliflozin for type 1 diabetes in the United States will also be reduced in the event we do not exercise our co-promotion option described below.
We will continue to be responsible for all clinical development activities relating to type 1 diabetes and will retain an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the United States. If we exercise our co-promotion option, we will fund forty percent of the commercialization costs relating to such co-promotion activities. Sanofi will be responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide and will be solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the United States. We will share in the funding of a portion of the planned type 2 diabetes development costs over the next three years, up to an aggregate of $100 million. Sanofi will book sales worldwide in all indications.
The parties are responsible for using commercially reasonable efforts to perform their development and commercialization obligations pursuant to mutually approved development and commercialization plans.
The parties’ activities under the Agreement are governed by a joint steering committee and certain other governance committees which reflect equal or other appropriate representation from both parties. If the applicable governance committee is not able to make a decision by consensus and the parties are not able to resolve the issue through escalation to specified senior executive officers of the parties, then Sanofi will have final decision-making authority, subject to limitations specified in the Agreement.
The Agreement will expire upon the expiration of all applicable royalty terms for all licensed products in all countries. The royalty term for each licensed product in each country is the period commencing on the effective date of the Agreement and ending on the latest of expiration of specified patent coverage, expiration of specified regulatory exclusivity and 10 years following the first commercial sale in the applicable country. Either party may terminate the Agreement in the event of an uncured material breach by the other party. Prior to completion of the core development activities for type 2 diabetes specified in the development plan, Sanofi may terminate the Agreement on a country-by-country and licensed product-by-licensed product basis, in the event of (a) notification of a material safety issue relating to the licensed product or the class of sodium-glucose cotransporters type 1 or type 2 inhibitors resulting in a recommendation or requirement that we or Sanofi cease development, (b) failure to achieve positive results with respect to certain clinical trial results, (c) the occurrence of specified fundamental adverse events or (d) the exploitation of the



Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

licensed product infringing third party intellectual property rights in specified major markets and Sanofi is unable to obtain a license to such third party intellectual property rights.
The effectiveness of the Agreement is contingent upon satisfaction of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
We issued a press release announcing the Agreement on November 6, 2015, a copy of which is attached to this current report on Form 8-K as Exhibit 99.1.
The foregoing description of the Agreement does not purport to be complete and is qualified in its entirety by reference to the Agreement, which we expect to file as an exhibit to our annual report on Form 10-K for the year ending December 31, 2015.

Item 9.01
Financial Statements and Exhibits

(d)    Exhibits

Exhibit No.
Description
99.1
-
Press Release of Lexicon Pharmaceuticals, Inc. dated November 6, 2015





Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

Signatures

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


 
Lexicon Pharmaceuticals, Inc.
 
 
 
 
 
 
 
 
Date: November 6, 2015
By:
 
 
 
Brian T. Crum
 
 
Vice President and General Counsel





Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

Index to Exhibits

Exhibit No.
Description
99.1
-
Press Release of Lexicon Pharmaceuticals, Inc. dated November 6, 2015








Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

Schedule 10.2.2
Existing Patents
Case Reference
Country
Internal Title
Current Status
Filing
Publication Number
Grant Number
LEX-1000-AR-NP
Argentina
SGLT2 Inhibitors
Publication of application
28 Sep 2007
AR063047A1
 
LEX-1000-AT-EPT
Austria
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-AT-ETD
Austria
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-AU-PCT
Australia
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2007304971
LEX-1000-BE-EPT
Belgium
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-BE-ETD
Belgium
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-BR-PCT
Brazil
SGLT2 Inhibitors
Publication of application
27 Sep 2007
2232
 
LEX-1000-CA-PCT
Canada
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2,664,688
LEX-1000-CH-EPT
Switzerland
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-CH-ETD
Switzerland
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-CN-DIV
China
SGLT2 Inhibitors
Publication of application
14 Mar 2013
CN 103254119A
 
LEX-1000-CN-NP
China
SGLT2 Inhibitors
Grant
02 Apr 2008
CN101343296A
ZL200810090073.9
LEX-1000-CZ-EPT
Czech Republic
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-CZ-ETD
Czech Republic
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-DE-EPT
Germany
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
602007012292.9
LEX-1000-DE-ETD
Germany
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-DK-EPT
Denmark
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-DK-ETD
Denmark
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-EA-EAT
Eurasian Procedure
SGLT2 Inhibitors
Grant
27 Sep 2007
 
016511
LEX-1000-EP-EPT
European Procedure (Patents)
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-EP-ETD
European Procedure (Patents)
SGLT2 Inhibitors
Grant
27 Sep 2007
2308841
2308841
LEX-1000-ES-EPT
Spain
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-ES-ETD
Spain
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-FR-EPT
France
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-FR-ETD
France
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-GB-EPT
United Kingdom
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-GB-ETD
United Kingdom
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-GR-EPT
Greece
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
3074740
LEX-1000-GR-ETD
Greece
SGLT2 Inhibitors
Grant
27 Sep 2007
 
3083670
LEX-1000-HK-FPD
Hong Kong
SGLT2 Inhibitors
Publication of application
04 Sep 2013
1183020A
 
LEX-1000-HK-FPR
Hong Kong
SGLT2 Inhibitors
Grant
19 Mar 2009
1124863A
HK1124863
LEX-1000-HU-EPT
Hungary
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-HU-ETD
Hungary
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-IE-EPT
Ireland
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361



Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

LEX-1000-IE-ETD
Ireland
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-IL-PCT
Israel
SGLT2 Inhibitors
Grant
27 Sep 2007
 
197836
LEX-1000-IN-PCT
India
SGLT2 Inhibitors
Grant
27 Sep 2007
 
258913
LEX-1000-IT-EPT
Italy
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-IT-ETD
Italy
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-JP-PCD
Japan
SGLT2 Inhibitors
Grant
20 Nov 2012
2013-079243
5701845
LEX-1000-JP-PCD[2]
Japan
SGLT2 Inhibitors
Publication of application
17 Feb 2015
2015-120736
 
LEX-1000-JP-PCT
Japan
SGLT2 Inhibitors
Grant
27 Sep 2007
2010-504998
5283625
LEX-1000-KR-PCT
South Korea / Republic of Korea
SGLT2 Inhibitors
Grant
27 Sep 2007
 
10-1492277
LEX-1000-MX-PCT
Mexico
SGLT2 Inhibitors
Grant
27 Sep 2007
 
287903
LEX-1000-NL-EPT
Netherlands
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-NL-ETD
Netherlands
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-NO-PCT
Norway
SGLT2 Inhibitors
Local filing
27 Sep 2007
 
 
LEX-1000-NZ-PCT
New Zealand
SGLT2 Inhibitors
Grant
27 Sep 2007
575811
575811
LEX-1000-PL-EPT
Poland
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-PL-ETD
Poland
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-PT-EPT
Portugal
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-PT-ETD
Portugal
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-RO-EPT
Romania
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-RO-ETD
Romania
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-RU-EAT
Russian Federation
SGLT2 Inhibitors
Grant
27 Sep 2007
 
016511
LEX-1000-SE-EPT
Sweden
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
2089361
LEX-1000-SE-ETD
Sweden
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2308841
LEX-1000-SG-PCT
Singapore
SGLT2 Inhibitors
Grant
27 Sep 2007
 
151038
LEX-1000-TR-EPT
Turkey
SGLT2 Inhibitors
Grant
27 Sep 2007
2089361
TR 2011 02757 T4
LEX-1000-TR-ETD
Turkey
SGLT2 Inhibitors
Grant
27 Sep 2007
 
TR 2014 05126 T4
LEX-1000-TW-NP
Taiwan
SGLT2 Inhibitors
Grant
19 Sep 2007
200826929
I499414
LEX-1000-UA-PCT
Ukraine
SGLT2 Inhibitors
Grant
27 Sep 2007
 
98123
LEX-1000-US-CNT
United States Of America
SGLT2 Inhibitors
Grant
18 Aug 2010
US 2010/0311673 A1
8,476,413
LEX-1000-US-CNT[2]
United States Of America
SGLT2 Inhibitors
Publication of application
25 Jun 2013
US 2014/0135277 A1
 
LEX-1000-US-NP
United States Of America
SGLT2 Inhibitors
Grant
27 Sep 2007
US-2008-0113922-A1
7,781,577
LEX-1000-US-NP[2]
United States Of America
SGLT2 Inhibitors
Grant
04 Mar 2008
US-2008-0221164-A1
7,846,945
LEX-1000-ZA-PCT
South Africa
SGLT2 Inhibitors
Grant
27 Sep 2007
 
2009/02231
LEX-1017-AR-NP
Argentina
Large Scale Process for LX4211
Publication of application
25 Jul 2008
AR067701 A1
 
LEX-1017-AT-EPT
Austria
Large Scale Process for LX4211
Grant
17 Jul 2008
E530558
2183263
LEX-1017-AU-PCD
Australia
Large Scale Process for LX4211
Filing
12 Jun 2013
 
 
LEX-1017-AU-PCT
Australia
Large Scale Process for LX4211
Grant
17 Jul 2008
 
2008279424



Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

LEX-1017-BE-EPT
Belgium
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-BR-PCT
Brazil
Large Scale Process for LX4211
Local filing
17 Jul 2008
 
 
LEX-1017-CA-PCT
Canada
Large Scale Process for LX4211
Local filing
17 Jul 2008
 
 
LEX-1017-CH-EPT
Switzerland
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-CN-PCT
China
Large Scale Process for LX4211
Publication of application
17 Jul 2008
CN 101801989A
 
LEX-1017-CZ-EPT
Czech Republic
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-DE-EPT
Germany
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
602008010937.2
LEX-1017-DK-EPT
Denmark
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-EA-EAT
Eurasian Procedure
Large Scale Process for LX4211
Grant
17 Jul 2008
 
017411
LEX-1017-EP-EPT
European Procedure (Patents)
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-ES-EPT
Spain
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-FR-EPT
France
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-GB-EPT
United Kingdom
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-GR-EPT
Greece
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
3076926
LEX-1017-HK-FPR
Hong Kong
Large Scale Process for LX4211
Filing
12 Nov 2010
 
 
LEX-1017-HU-EPT
Hungary
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-IE-EPT
Ireland
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-IL-PCT
Israel
Large Scale Process for LX4211
Grant
17 Jul 2008
 
203209
LEX-1017-IN-PCT
India
Large Scale Process for LX4211
Publication of application
17 Jul 2008
30/2010
 
LEX-1017-IT-EPT
Italy
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-JP-PCD
Japan
Large Scale Process for LX4211
Grant
28 Aug 2013
2014-001230
5764174
LEX-1017-JP-PCT
Japan
Large Scale Process for LX4211
Grant
17 Jul 2008
2010-534661
5653213
LEX-1017-KR-PCT
South Korea / Republic of Korea
Large Scale Process for LX4211
Local filing
17 Jul 2008
 
 
LEX-1017-MX-PCT
Mexico
Large Scale Process for LX4211
Grant
17 Jul 2008
 
296552
LEX-1017-NL-EPT
Netherlands
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263



Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

LEX-1017-NZ-PCT
New Zealand
Large Scale Process for LX4211
Grant
17 Jul 2008
 
582536
LEX-1017-PL-EPT
Poland
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-PT-EPT
Portugal
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-RO-EPT
Romania
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-RU-EAT
Russian Federation
Large Scale Process for LX4211
Grant
17 Jul 2008
 
017411
LEX-1017-SE-EPT
Sweden
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
2183263
LEX-1017-SG-PCT
Singapore
Large Scale Process for LX4211
Grant
17 Jul 2008
 
158399
LEX-1017-TR-EPT
Turkey
Large Scale Process for LX4211
Grant
17 Jul 2008
2183263
TR 2011 12632 T4
LEX-1017-TW-DIV
Taiwan
Large Scale Process for LX4211
Publication of application
16 Aug 2013
201350473
 
LEX-1017-TW-NP
Taiwan
Large Scale Process for LX4211
Grant
21 Jul 2008
200914434
I419886
LEX-1017-UA-PCT
Ukraine
Large Scale Process for LX4211
Grant
17 Jul 2008
 
107175
LEX-1017-US-CNT
United States Of America
Large Scale Process for LX4211
Grant
11 Aug 2011
US-2012-0095198-A1
8,293,878
LEX-1017-US-NP
United States Of America
Large Scale Process for LX4211
Grant
17 Jul 2008
US-2009-0030198-A1
8,026,347
LEX-1017-WO-PCT
International Procedure
Large Scale Process for LX4211
Expiry date
17 Jul 2008
WO2009/014970
 
LEX-1017-ZA-PCT
South Africa
Large Scale Process for LX4211
Grant
17 Jul 2008
 
2010/00219
LEX-1287-AR-NP
Argentina
Solid Anhydrous Forms of LX4211
Publication of application
15 Jul 2009
AR072807 A1
 
LEX-1287-AU-PCT
Australia
Solid Anhydrous Forms of LX4211
Grant
15 Jul 2009
 
2009270973
LEX-1287-BR-PCT
Brazil
Solid Anhydrous Forms of LX4211
Local filing
15 Jul 2009
 
 
LEX-1287-CA-PCT
Canada
Solid Anhydrous Forms of LX4211
Local filing
15 Jul 2009
 
 
LEX-1287-CN-PCT
China
Solid Anhydrous Forms of LX4211
Publication of application
15 Jul 2009
CN 102112483A
 
LEX-1287-EP-ETD
European Procedure (Patents)
Solid Anhydrous Forms of LX4211
Publication of application
18 Feb 2011
2332947
 
LEX-1287-HK-FPR
Hong Kong
Solid Anhydrous Forms of LX4211
Publication of application
22 Jul 2011
1153480A
 
LEX-1287-IL-PCT
Israel
Solid Anhydrous Forms of LX4211
Publication of application
15 Jul 2009
 
 
LEX-1287-IN-PCT
India
Solid Anhydrous Forms of LX4211
Publication of application
15 Jul 2009
2264
 
LEX-1287-JP-PCD
Japan
Solid Anhydrous Forms of LX4211
Filing
30 Sep 2015
 
 



Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

LEX-1287-KR-PCT
South Korea / Republic of Korea
Solid Anhydrous Forms of LX4211
Local Filing
15 Jul 2009
 
 
LEX-1287-MX-PCT
Mexico
Solid Anhydrous Forms of LX4211
Grant
15 Jul 2009
 
329600
LEX-1287-NZ-PCT
New Zealand
Solid Anhydrous Forms of LX4211
Grant
15 Jul 2009
 
590184
LEX-1287-RU-PCT
Russian Federation
Solid Anhydrous Forms of LX4211
Grant
15 Jul 2009
 
2505543
LEX-1287-SG-PCD
Singapore
Solid Anhydrous Forms of LX4211
Publication of application
18 Oct 2012
185317
 
LEX-1287-TH-NP
Thailand
Solid Anhydrous Forms of LX4211
Publication of application
09 Jul 2009
122363
 
LEX-1287-TW-NP
Taiwan
Solid Anhydrous Forms of LX4211
Grant
01 Jul 2009
201006808
I472521
LEX-1287-UA-PCT
Ukraine
Solid Anhydrous Forms of LX4211
Grant
15 Jul 2009
 
106048
LEX-1287-US-CNT
United States Of America
Solid Anhydrous Forms of LX4211
Grant
22 Jun 2012
US 2013/0165395 A1
9,067,962
LEX-1287-US-NP
United States Of America
Solid Anhydrous Forms of LX4211
Grant
15 Jul 2009
US-2010-0016422-A1
8,217,156
LEX-1287-ZA-PCT
South Africa
Solid Anhydrous Forms of LX4211
Grant
15 Jul 2009
 
2011/00175
LEX-1309-AR-NP
Argentina
Methods of Using Dual SGLT1/2 Inhibitors
Publication of application
02 Mar 2011
AR 080444 A1
 
LEX-1309-AU-PCT
Australia
Methods of Using Dual SGLT1/2 Inhibitors
Local filing
01 Mar 2011
 
 
LEX-1309-BR-PCT
Brazil
Methods of Using Dual SGLT1/2 Inhibitors
Local filing
01 Mar 2011
 
 
LEX-1309-CA-PCT
Canada
Methods of Using Dual SGLT1/2 Inhibitors
Local filing
01 Mar 2011
 
 
LEX-1309-EP-EPT
European Procedure (Patents)
Methods of Using Dual SGLT1/2 Inhibitors
Publication of application
01 Mar 2011
2542236
 
LEX-1309-IN-PCT
India
Methods of Using Dual SGLT1/2 Inhibitors
Local filing
01 Mar 2011
 
 
LEX-1309-JP-PCT
Japan
Methods of Using Dual SGLT1/2 Inhibitors
Publication of application
01 Mar 2011
2013-521293
 
LEX-1309-KR-PCT
South Korea / Republic of Korea
Methods of Using Dual SGLT1/2 Inhibitors
Local filing
01 Mar 2011
 
 
LEX-1309-MX-PCT
Mexico
Methods of Using Dual SGLT1/2 Inhibitors
Local filing
01 Mar 2011
 
 
LEX-1309-TW-NP
Taiwan
Methods of Using Dual SGLT1/2 Inhibitors
Publication of application
14 Feb 2011
201130486
 
LEX-1309-US-CNT
United States Of America
Methods of Using Dual SGLT1/2 Inhibitors
Publication of application
10 Jun 2013
US 2014/0018308 A1
 
LEX-1309-US-CNT[2]
United States Of America
Methods of Using Dual SGLT1/2 Inhibitors
Filing
06 Oct 2015
 
 
LEX-1321-AR-NP
Argentina
Solid Dosage Forms of LX4211
Publication of application
04 Jan 2012
AR084781 A1
 
LEX-1321-AU-PCT
Australia
Solid Dosage Forms of LX4211
Local filing
03 Jan 2012
 
 



Confidential materials omitted and filed separately
with the Securities and Exchange Commission.
Asterisks denote omissions.

LEX-1321-BR-PCT
Brazil
Solid Dosage Forms of LX4211
Local filing
03 Jan 2012
 
 
LEX-1321-CA-PCT
Canada
Solid Dosage Forms of LX4211
Local filing
03 Jan 2012
 
 
LEX-1321-EP-EPT
European Procedure (Patents)
Solid Dosage Forms of LX4211
Publication of application
03 Jan 2012
2661256
 
LEX-1321-IL-PCT
Israel
Solid Dosage Forms of LX4211
Local filing
03 Jan 2012
 
 
LEX-1321-IN-PCT
India
Solid Dosage Forms of LX4211
Local filing
03 Jan 2012
 
 
LEX-1321-JP-PCT
Japan
Solid Dosage Forms of LX4211
Publication of application
03 Jan 2012
2014-501780
 
LEX-1321-KR-PCT
South Korea / Republic of Korea
Solid Dosage Forms of LX4211
Local filing
03 Jan 2012
 
 
LEX-1321-MX-PCT
Mexico
Solid Dosage Forms of LX4211
Local filing
03 Jan 2012
 
 
LEX-1321-NZ-PCT
New Zealand
Solid Dosage Forms of LX4211
Local filing
03 Jan 2012
 
 
LEX-1321-RU-PCT
Russian Federation
Solid Dosage Forms of LX4211
Publication of application
03 Jan 2012
 
 
LEX-1321-SG-PCT
Singapore
Solid Dosage Forms of LX4211
Local filing
03 Jan 2012
 
 
LEX-1321-TH-PCT
Thailand
Solid Dosage Forms of LX4211
Local filing
03 Jan 2012
 
 
LEX-1321-TW-NP
Taiwan
Solid Dosage Forms of LX4211
Publication of application
02 Jan 2012
201309345
 
LEX-1321-US-CNT
United States Of America
Solid Dosage Forms of LX4211
Publication of application
30 May 2014
US 2015/0111840 A1
 
LEX-1321-WO-PCT
International Procedure
Solid Dosage Forms of LX4211
Publication of application
03 Jan 2012
WO 2012/094293
 
LEX-1321-ZA-PCT
South Africa
Solid Dosage Forms of LX4211
Grant
03 Jan 2012
 
2013/04694




Exhibit


Exhibit 23.1

Consent of Independent Registered Public Accounting Firm


We consent to the incorporation by reference in the following Registration Statements:

(1)
Registration Statements (Form S-8 Nos. 333-41532, 333-168678 and 333-183020) pertaining to the Equity Incentive Plan and to the Non-Employee Directors' Equity Incentive Plan of Lexicon Pharmaceuticals, Inc., and
(2)
Registration Statements (Form S-3 Nos. 333-182859, 333-198493 and 333-200699) of Lexicon Pharmaceuticals, Inc.
of our reports dated March 11, 2016, with respect to the consolidated financial statements of Lexicon Pharmaceuticals, Inc. and the effectiveness of internal control over financial reporting of Lexicon Pharmaceuticals, Inc., included in this annual report (Form 10-K) of Lexicon Pharmaceuticals, Inc. for the year ended December 31, 2015.


/s/ Ernst & Young LLP


Houston, Texas
March 11, 2016



Exhibit


 
Exhibit 31.1
CERTIFICATIONS
 
I, Lonnel Coats, certify that:
 
1.
I have reviewed this Annual Report on Form 10-K of Lexicon Pharmaceuticals, Inc.;
 
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.
The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
 
a)
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
 
b)
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
 
c)
evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
 
d)
disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
 
5.
The registrant's other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent functions)
 
 
a)
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
 
 
b)
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Date: March 11, 2016

 
/s/ Lonnel Coats
 
Lonnel Coats
President and Chief Executive Officer



Exhibit


Exhibit 31.2
CERTIFICATIONS
 
I, Jeffrey L. Wade, certify that:
 
1.
I have reviewed this Annual Report on Form 10-K of Lexicon Pharmaceuticals, Inc.;
 
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
 
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.
The registrant's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
 
 
a)
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
 
 
b)
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
 
 
c)
evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
 
 
d)
disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
 
5.
The registrant's other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent functions):
 
 
a)
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
 
 
b)
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

Date: March 11, 2016

 
/s/ Jeffrey L. Wade
 
Jeffrey L. Wade
Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer





Exhibit


 
Exhibit 32.1
 
CERTIFICATION
 
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C. 1350, as adopted), Lonnel Coats, Principal Executive Officer of Lexicon Pharmaceuticals, Inc. (“Lexicon”), and Jeffrey L. Wade, Principal Financial Officer of Lexicon, each hereby certify that:
 
1.
Lexicon's Annual Report on Form 10-K for the year ended December 31, 2015, and to which this Certification is attached as Exhibit 32.1 (the “Periodic Report”), fully complies with the requirements of section 13(a) or section 15(d) of the Securities Exchange Act of 1934, and
 
2.
The information contained in the Periodic Report fairly presents, in all material respects, the financial condition and results of operations of Lexicon.

IN WITNESS WHEREOF, the undersigned have set their hands hereto as of the 11th day of March, 2016.
 
 
By:
/s/ Lonnel Coats
 
 
Lonnel Coats
President and Chief Executive Officer

 
 
By:
/s/ Jeffrey L. Wade
 
 
Jeffrey L. Wade
Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer




lxrx-20151231.xml
Attachment: XBRL INSTANCE DOCUMENT


lxrx-20151231.xsd
Attachment: XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT


lxrx-20151231_cal.xml
Attachment: XBRL TAXONOMY EXTENSION CALCULATION LINKBASE DOCUMENT


lxrx-20151231_def.xml
Attachment: XBRL TAXONOMY EXTENSION DEFINITION LINKBASE DOCUMENT


lxrx-20151231_lab.xml
Attachment: XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT


lxrx-20151231_pre.xml
Attachment: XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT


v3.3.1.900
Document and Entity Information Document - USD ($)
12 Months Ended
Dec. 31, 2015
Mar. 07, 2016
Jun. 30, 2015
Document Information      
Entity Registrant Name LEXICON PHARMACEUTICALS, INC./DE    
Entity Central Index Key 0001062822    
Current Fiscal Year End Date --12-31    
Entity Filer Category Accelerated Filer    
Document Type 10-K    
Document Period End Date Dec. 31, 2015    
Document Fiscal Year Focus 2015    
Document Fiscal Period Focus FY    
Amendment Flag false    
Entity Common Stock, Shares Outstanding   103,769,656  
Entity Well-known Seasoned Issuer No    
Entity Voluntary Filers No    
Entity Current Reporting Status Yes    
Entity Public Float     $ 335,000,000

v3.3.1.900
Consolidated Balance Sheets - USD ($)
$ in Thousands
Dec. 31, 2015
Dec. 31, 2014
Current assets:    
Cash and cash equivalents $ 202,989 $ 137,266
Short-term investments, including restricted investments of $0 and $430, respectively 318,363 202,073
Accounts receivable, net of allowances of $4 and $35, respectively 911 1,035
Assets held for sale 0 23,849
Prepaid expenses and other current assets 10,137 4,764
Total current assets 532,400 368,987
Property and equipment, net of accumulated depreciation and amortization of $59,428 and $36,274, respectively 21,227 1,080
Goodwill 44,543 44,543
Other intangible assets 53,357 53,357
Other assets 3,305 3,409
Total assets 654,832 471,376
Current liabilities:    
Accounts payable 19,725 13,064
Accrued liabilities 24,757 10,120
Current portion of deferred revenue 76,499 1,618
Current portion of long-term debt 2,015 20,167
Total current liabilities 122,996 44,969
Deferred revenue, net of current portion 109,151 12,679
Long-term debt 103,793 87,500
Deferred tax liabilities 18,675 18,675
Other long-term liabilities 14,367 23,535
Total liabilities $ 368,982 $ 187,358
Commitments and contingencies
Equity:    
Preferred stock, $.01 par value; 5,000 shares authorized; no shares issued and outstanding $ 0 $ 0
Common stock, $.001 par value; 225,000 and 128,571 shares authorized; 103,860 and 103,663 shares issued, respectively 104 104
Additional paid-in capital 1,397,646 1,390,619
Accumulated deficit (1,108,934) (1,104,252)
Accumulated other comprehensive loss (219) (63)
Treasury stock, at cost, 237 and 183 shares, respectively (2,747) (2,390)
Total equity 285,850 284,018
Total liabilities and equity $ 654,832 $ 471,376

v3.3.1.900
Balance Sheet Parentheticals - USD ($)
shares in Thousands, $ in Thousands
Dec. 31, 2015
Dec. 31, 2014
Restricted investments $ 0 $ 430
Allowance for doubtful accounts receivable 4 35
Accumulated depreciation and amortization, property and equipment $ 59,428 $ 36,274
Preferred stock, par value per share $ 0.01 $ 0.01
Preferred stock, shares authorized 5,000 5,000
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
Common stock, par value per share $ 0.001 $ 0.001
Common stock, shares authorized 225,000 128,571
Treasury stock, shares 237 183
Common Stock    
Common stock, shares issued 103,860 103,663

v3.3.1.900
Consolidated Statements of Comprehensive Loss - USD ($)
shares in Thousands, $ in Thousands
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Revenues:      
Collaborative agreements $ 129,728 $ 22,593 $ 2,109
Subscription and license fees 286 261 113
Total revenues 130,014 22,854 2,222
Operating expenses:      
Research and development, including stock-based compensation of $3,693, $4,020 and $4,376, respectively 95,187 89,279 89,682
Increase (decrease) in fair value of Symphony Icon, Inc. purchase liability 5,927 1,428 (2,210)
General and administrative, including stock-based compensation of $3,150, $3,061 and $3,045, respectively 23,835 19,411 17,121
Impairment loss on buildings 3,597 13,102 0
Total operating expenses 128,546 123,220 104,593
Income (loss) from operations 1,468 (100,366) (102,371)
Interest expense (6,722) (2,253) (1,971)
Interest and other income, net 572 2,255 216
Consolidated net loss before taxes (4,682) (100,364) (104,126)
Income tax benefit 0 70 0
Consolidated net loss $ (4,682) $ (100,294) $ (104,126)
Consolidated net loss per common share, basic and diluted $ (0.05) $ (1.31) $ (1.42)
Shares used in computing consolidated net loss per common share, basic and diluted 103,591 76,347 73,302
Other comprehensive loss:      
Unrealized loss on investments $ (156) $ (65) $ (21)
Comprehensive loss $ (4,838) $ (100,359) $ (104,147)

v3.3.1.900
Statements of Comprehensive Loss Parentheticals (Parentheticals) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Stock-based compensation expense associated with research and development expense $ 3,693 $ 4,020 $ 4,376
Stock-based compensation expense associated with general and administrative expense $ 3,150 $ 3,061 $ 3,045

v3.3.1.900
Consolidated Statements of Stockholders' Equity - USD ($)
shares in Thousands, $ in Thousands
Total
Common Stock
Additional Paid-In Capital
Accumulated Deficit
Accumulated Other Comprehensive Gain (Loss)
Treasury Stock
Balance, shares at Dec. 31, 2012   73,196        
Balance, value at Dec. 31, 2012 $ 266,678 $ 73 $ 1,167,044 $ (899,832) $ 23 $ (630)
Stock-based compensation 7,421 $ 0 7,421 0 0 0
Issuance of common stock to designees of Symphony Icon Holdings LLC, value 0          
Issuance of common stock under Equity Incentive Plans, shares   282        
Issuance of common stock under Equity Incentive Plans, value 1,084 $ 0 1,084 0 0 0
Repurchase of common stock (873) 0 0 0 0 (873)
Net loss (104,126) 0 0 (104,126) 0 0
Unrealized loss on investments (21) $ 0 0 0 (21) 0
Balance, shares at Dec. 31, 2013   73,478        
Balance, value at Dec. 31, 2013 170,163 $ 73 1,175,549 (1,003,958) 2 (1,503)
Stock-based compensation 7,081 $ 0 7,081 0 0 0
Issuance of common stock to designees of Symphony Icon Holdings LLC, shares   666        
Issuance of common stock to designees of Symphony Icon Holdings LLC, value 5,750 $ 1 5,749 0 0 0
Issuance of common stock under Equity Incentive Plans, shares   252        
Issuance of common stock under Equity Incentive Plans, value 323 $ 1 322 0 0 0
Issuance of common stock, net of fees, shares   29,267        
Issuance of common stock, net of fees, value 201,947 $ 29 201,918 0 0 0
Repurchase of common stock (887) 0 0 0 0 (887)
Net loss (100,294) 0 0 (100,294) 0 0
Unrealized loss on investments (65) $ 0 0 0 (65) 0
Balance, shares at Dec. 31, 2014   103,663        
Balance, value at Dec. 31, 2014 284,018 $ 104 1,390,619 (1,104,252) (63) (2,390)
Stock-based compensation 6,843 $ 0 6,843 0 0 0
Issuance of common stock to designees of Symphony Icon Holdings LLC, value 0          
Issuance of common stock under Equity Incentive Plans, shares   197        
Issuance of common stock under Equity Incentive Plans, value 114 $ 0 114 0 0 0
Repurchase of common stock (357) 0 0 0 0 (357)
Net loss (4,682) 0 0 (4,682) 0 0
Unrealized loss on investments (156) 0 0 0 (156) 0
Other 70 $ 0 70 0 0 0
Balance, shares at Dec. 31, 2015   103,860        
Balance, value at Dec. 31, 2015 $ 285,850 $ 104 $ 1,397,646 $ (1,108,934) $ (219) $ (2,747)

v3.3.1.900
Consolidated Statements of Cash Flows - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Cash flows from operating activities:      
Consolidated net loss $ (4,682) $ (100,294) $ (104,126)
Adjustments to reconcile consolidated net loss to net cash provided by (used in) operating activities:      
Depreciation and amortization 727 1,928 2,863
Impairment of assets 3,597 13,544 0
Increase (decrease) in fair value of Symphony Icon, Inc. purchase liability 5,927 1,428 (2,210)
Stock-based compensation 6,843 7,081 7,421
Gain on disposal of property and equipment (47) (1,631) 0
Amortization of debt issuance costs 520 100 0
Deferred tax benefit 0 (70) 0
Changes in operating assets and liabilities:      
Decrease in accounts receivable 124 457 588
(Increase) decrease in prepaid expenses and other current assets (5,373) (128) 1,713
Increase in other assets (416) 0 (9)
Increase in accounts payable and other liabilities 6,203 1,266 3,119
Increase (decrease) in deferred revenue 171,353 697 (438)
Net cash provided by (used in) operating activities 184,776 (75,622) (91,079)
Cash flows from investing activities:      
Purchases of property and equipment (910) (80) (1,721)
Proceeds from disposal of property and equipment 335 2,170 130
Purchases of investments (326,446) (221,953) (111,490)
Maturities of investments 210,000 111,444 212,625
Net cash provided by (used in) investing activities (117,021) (108,419) 99,544
Cash flows from financing activities:      
Proceeds from issuance of common stock, net of fees 114 202,270 1,084
Repurchase of common stock (357) (887) (873)
Proceeds from debt borrowings, net of fees 0 84,135 0
Repayment of debt borrowings (1,859) (1,710) (1,574)
Other financing activities 70 0 (26)
Net cash provided by (used in) financing activities (2,032) 283,808 (1,389)
Net increase in cash and cash equivalents 65,723 99,767 7,076
Cash and cash equivalents at beginning of year 137,266 37,499 30,423
Cash and cash equivalents at end of year 202,989 137,266 37,499
Supplemental disclosure of cash flow information:      
Cash paid for interest 6,270 1,761 1,897
Supplemental disclosure of noncash investing and financing activities:      
Unrealized loss on investments (156) (65) (21)
Common stock issued in satisfaction of Symphony Icon base payment obligation $ 0 $ 5,750 $ 0

v3.3.1.900
Organization and Operations
12 Months Ended
Dec. 31, 2015
Organization and Operations [Abstract]  
Organization and Operations
Organization and Operations
 
Lexicon Pharmaceuticals, Inc. (“Lexicon” or the “Company”) is a Delaware corporation incorporated on July 7, 1995. Lexicon was organized to discover the functions and pharmaceutical utility of genes and use those gene function discoveries in the discovery and development of pharmaceutical products for the treatment of human disease.
 
Lexicon has financed its operations from inception primarily through sales of common and preferred stock, contract and milestone payments to it under strategic collaborations and other research and development collaborations, target validation, database subscription and technology license agreements, government grants and contracts and financing under debt and lease arrangements. The Company’s future success is dependent upon many factors, including, but not limited to, its ability to develop and obtain regulatory approval for its products, successfully commercialize its products which gain regulatory approval, achieve milestones under its collaboration agreements, establish new collaboration and license agreements, obtain and enforce patents and other proprietary rights in its discoveries, comply with federal and state regulations, and maintain sufficient capital to fund its activities.  As a result of the aforementioned factors and the related uncertainties, there can be no assurance of the Company’s future success.

v3.3.1.900
Summary of Significant Accounting Policies
12 Months Ended
Dec. 31, 2015
Summary of Significant Accounting Policies [Abstract]  
Summary of Significant Accounting Policies
Summary of Significant Accounting Policies
 
Basis of Presentation: The accompanying consolidated financial statements include the accounts of Lexicon and its wholly-owned subsidiaries. Intercompany transactions and balances are eliminated in consolidation.
 
Use of Estimates: The preparation of financial statements in conformity with U. S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates.
 
Cash, Cash Equivalents and Short-Term Investments: Lexicon considers all highly-liquid investments with original maturities of three months or less to be cash equivalents.  As of December 31, 2015, short-term investments consist of U.S. treasury bills and corporate debt securities. As of December 31, 2014, short-term investments consist of U.S. treasury bills and certificates of deposit. The Company’s short-term investments are classified as available-for-sale securities and are carried at fair value, based on quoted market prices of the securities.  The Company views its available-for-sale securities as available for use in current operations regardless of the stated maturity date of the security.  Unrealized gains and losses on such securities are reported as a separate component of stockholders’ equity.  Net realized gains and losses, interest and dividends are included in interest income.  The cost of securities sold is based on the specific identification method.
 
Restricted Cash and Investments:  Lexicon was required to maintain restricted cash or investments to collateralize standby letters of credit for the lease on its office and laboratory facilities in Hopewell, New Jersey that terminated in June 2015.  As of December 31, 2015 and 2014, restricted cash and investments were zero and $0.4 million, respectively.
 
Accounts Receivable:  Lexicon records trade accounts receivable in the normal course of business related to the sale of products or services.   The allowance for doubtful accounts takes into consideration such factors as historical write-offs, the economic climate and other factors that could affect collectibility.  Write-offs are evaluated on a case by case basis.
 
Concentration of Credit Risk: Lexicon’s cash equivalents, investments and accounts receivable represent potential concentrations of credit risk. The Company attempts to minimize potential concentrations of risk in cash equivalents and investments by placing investments in high-quality financial instruments. The Company’s accounts receivable are unsecured and are concentrated in pharmaceutical and biotechnology companies located in the United States.  The Company has not experienced any significant credit losses to date.  In 2015, customers in France and the United States represented 99% and 1% of revenue, respectively. In 2014, customers in France and the United States represented 94% and 6%, respectively. In 2013, customers in the United States represented 100% of revenue.  At December 31, 2015, management believes that the Company has no significant concentrations of credit risk.
 
Segment Information and Significant Customers: Lexicon operates in one business segment, which primarily focuses on the discovery of the functions and pharmaceutical utility of genes and the use of those gene function discoveries in the discovery and development of pharmaceutical products for the treatment of human disease. Substantially all of the Company’s revenues have been derived from drug discovery alliances, target validation collaborations for the development and, in some cases, analysis of the physiological effects of genes altered in knockout mice, technology licenses, subscriptions to its databases, government grants and contracts and compound library sales. In 2015, Sanofi represented 98% of revenues. In 2014, Ipsen Pharma SAS represented 94% of revenues. In 2013, McNair Medical Institute, LLC and Taconic Farms, Inc. represented 57% and 33% of revenues, respectively.    
 
Property and Equipment: Property and equipment that is held and used is carried at cost and depreciated using the straight-line method over the estimated useful life of the assets which ranges from three to 40 years.  Maintenance, repairs and minor replacements are charged to expense as incurred.  Leasehold improvements are amortized over the shorter of the estimated useful life or the remaining lease term.  Significant renewals and betterments are capitalized.
 
Impairment of Long-Lived Assets:  Long-lived assets and certain identifiable intangible assets to be held and used are reviewed for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by comparison of the carrying amount of an asset to future net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount that the carrying amount of the assets exceeds the fair value of the assets. Assets to be disposed of are reported at the lower of the carrying amount or fair value less costs to sell. In 2014, Lexicon reclassified its buildings and land as assets held for sale, as it intended to sell these assets, and recorded an impairment loss of $13.1 million in the year ended December 31, 2014. In the fourth quarter of 2015, Lexicon made a change to its plan of sale and reclassified its buildings and land as assets held and used in accordance with the accounting guidance regarding selling assets with a leaseback requirement, and recorded an additional impairment loss of $3.6 million in the year ended December 31, 2015 (see Note 6, Buildings and Land for Sale).

Indefinite lived intangible assets are also tested annually for impairment and whenever indicators of impairment are present. When performing the impairment assessment, the Company first assesses qualitative factors to determine whether it is necessary to recalculate the fair value of its intangible assets. If management believes, as a result of the qualitative assessment, that it is more likely than not that the fair value of the intangible assets is less than its carrying amount, the Company calculates the asset’s fair value. If the carrying value of the asset exceeds its fair value, then the intangible asset is written down to its fair value.

Goodwill Impairment:  Goodwill is not amortized, but is tested at least annually for impairment at the reporting unit level.  The Company has determined that the reporting unit is the single operating segment disclosed in its current financial statements. Impairment is the condition that exists when the carrying amount of goodwill exceeds its implied fair value.  The first step in the impairment process is to determine the fair value of the reporting unit and then compare it to the carrying value, including goodwill.  If the fair value exceeds the carrying value, no further action is required and no impairment loss is recognized.  Additional impairment assessments may be performed on an interim basis if the Company encounters events or changes in circumstances that would indicate that, more likely than not, the carrying value of goodwill has been impaired.  There was no impairment of goodwill in 2015, 2014 or 2013.
 
Revenue Recognition: Revenues are recognized when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectibility is reasonably assured.  

Collaborative agreements revenues include both license revenue and contract research revenue. Activities under collaborative agreements are evaluated to determine if they represent a multiple element revenue agreement. The Company identifies the deliverables included within the agreement and evaluates which deliverables represent separate units of accounting. The Company accounts for those components as separate units of accounting if the following two criteria are met:

The delivered item or items have value to the customer on a stand-alone basis.
If there is a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and within the Company’s control.

Factors considered in this determination include, among other things, whether any other vendors sell the items separately and if the licensee could use the delivered item for its intended purpose without the receipt of the remaining deliverables. If multiple deliverables included in an arrangement are separable into different units of accounting, the Company allocates the arrangement consideration to those units of accounting. The amount of allocable arrangement consideration is limited to amounts that are fixed or determinable. Arrangement consideration is allocated at the inception of the arrangement to the identified units of accounting based on their relative estimated selling price. Revenue is recognized for each unit of accounting when the appropriate revenue recognition criteria are met.

Future milestone payments that are contingent upon the achievement of a substantive milestone are recognized in their entirety in the period in which the milestone is achieved. A milestone is substantive if:

It can only be achieved based in whole or in part on either the Company’s performance or on the occurrence of a specific outcome resulting from the Company’s performance;
There is substantive uncertainty at the date an arrangement is entered into that the event will be achieved; and
It would result in additional payments being due to the Company.

Subscription and license fees are recognized as revenue upon the grant of the technology license when performance is complete and there is no continuing involvement. Royalty revenues are recognized as earned in accordance with the contract terms at the time the royalty amount is fixed and determinable based on information received from the sublicensees and at the time collectibility is reasonably assured.

Research and Development Expenses: Research and development expenses consist of costs incurred for company-sponsored as well as collaborative research and development activities. These costs include direct and research-related overhead expenses and are expensed as incurred.  Technology license fees for technologies that are utilized in research and development and have no alternative future use are expensed when incurred. Substantial portions of the Company’s preclinical and clinical trials are performed by third-party laboratories, medical centers, contract research organizations and other vendors. For preclinical studies, the Company accrues expenses based upon estimated percentage of work completed and the contract milestones remaining. For clinical studies, expenses are accrued based upon the number of patients enrolled and the duration of the study. The Company monitors patient enrollment, the progress of clinical studies and related activities to the extent possible through internal reviews of data reported to the Company by the vendors and clinical site visits. The Company’s estimates depend on the timeliness and accuracy of the data provided by the vendors regarding the status of each program and total program spending. The Company periodically evaluates the estimates to determine if adjustments are necessary or appropriate based on information it receives.
 
Stock-Based Compensation:  The Company recognizes compensation expense in its statements of comprehensive loss for share-based payments, including stock options and restricted stock units issued to employees, based on their fair values on the date of the grant, with the compensation expense recognized over the period in which an employee is required to provide service in exchange for the stock award.  Stock-based compensation expense for awards without performance conditions is recognized on a straight-line basis. Stock-based compensation expense for awards with performance conditions is recognized over the period from the date the performance condition is determined to be probable of occurring through the time the applicable condition is met.  As of December 31, 2015, stock-based compensation cost for all outstanding unvested options and restricted stock units was $10.5 million, which is expected to be recognized over a weighted-average period of 1.3 years.
 
The fair value of stock options is estimated at the date of grant using the Black-Scholes method.  The Black-Scholes option-pricing model requires the input of subjective assumptions.  Because the Company’s employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in management’s opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its employee stock options.  For purposes of determining the fair value of stock options, the Company segregates its options into two homogeneous groups, based on exercise and post-vesting employment termination behaviors, resulting in a change in the assumptions used for expected option lives and forfeitures.  Expected volatility is based on the historical volatility in the Company’s stock price.  The following weighted-average assumptions were used for options granted in the years ended December 31, 2015, 2014 and 2013, respectively:
 
Expected Volatility
 
Risk-free Interest Rate
 
Expected Term
 
Dividend
Rate
December 31, 2015:
 
 
 
 
 
 
 
Employees
64%
 
1.2%
 
4
 
0
%
Officers and non-employee directors
81%
 
1.8%
 
8
 
0
%
December 31, 2014:

 

 

 

Employees
66%
 
1.2%
 
4
 
0
%
Officers and non-employee directors
80%
 
2.3%
 
8
 
0
%
December 31, 2013:

 

 

 

Employees
85%
 
0.9%
 
5
 
0
%
Officers and non-employee directors
81%
 
1.6%
 
8
 
0
%

 
Net Loss per Common Share: Net loss per common share is computed using the weighted average number of shares of common stock outstanding. Shares associated with convertible debt, stock options and restricted stock units are not included because they are antidilutive.

v3.3.1.900
Recent Accounting Pronouncements
12 Months Ended
Dec. 31, 2015
Recent Accounting Pronouncements [Abstract]  
New Accounting Pronouncements and Changes in Accounting Principles [Text Block]
Recent Accounting Pronouncements
 
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers”, which amends FASB ASC Topic 606. ASU 2014-09 provides a single, comprehensive revenue recognition model for all contracts with customers. This standard contains principles for the determination of the measurement of revenue and the timing of when such revenue is recognized. Revenue recognition will reflect the transfer of goods or services to customers at an amount that is expected to be earned in exchange for those goods or services. ASU 2014-09 was scheduled to be effective for annual reporting periods beginning after December 15, 2016, and early adoption was not permitted. In August 2015, the FASB issued ASU No. 2015-14, “Revenue from Contracts with Customers: Deferral of Effective Date”, which defers the effective date of ASU 2014-09 by one year. ASU 2014-19 is now effective for annual periods after December 15, 2017 including interim periods within that reporting period. Early application is permitted only for annual periods beginning after December 15, 2016, including interim periods within that reporting period. Management is currently evaluating the impact of this pronouncement on Lexicon’s consolidated financial statements.

In August 2014, the FASB issued ASU No. 2014-15, “Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern.” ASU 2014-15 will explicitly require management to assess an entity’s ability to continue as a going concern, and to provide related footnote disclosure in certain circumstances. This pronouncement is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016, and early adoption is permitted. Management does not expect the adoption of this pronouncement to have a material impact on Lexicon’s consolidated financial statements.

In April 2015, the FASB issued ASU No. 2015-03, “Simplifying the Presentation of Debt Issuance Costs.” ASU
2015-03 requires that debt issuance costs related to a recognized debt liability be presented in the balance sheet as a direct
deduction from the carrying amount of that debt liability, consistent with debt discounts. This pronouncement is effective for
fiscal years, and interim periods within those years, beginning after December 15, 2015, and early adoption is permitted. Management does not expect the adoption of this pronouncement to have a material impact on Lexicon’s consolidated financial statements.

In January 2016, the FASB issued ASU No. 2016-01, “Recognition and Measurement of Financial Assets and Financial Liabilities.” ASU 2016-01 requires that most equity investments be measured at fair value, with subsequent changes in fair value recognized in net income. The pronouncement also impacts financial liabilities under the fair value option and the presentation and disclosure requirements for financial instruments. This pronouncement is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017, and early adoption is not permitted. Management does not expect the adoption of this pronouncement to have a material impact on Lexicon’s consolidated financial statements.

In February 2016, the FASB issued ASU No. 2016-02, “Leases.” ASU 2016-01 requires companies that lease assets to recognize a right-of-use asset and a lease liability, initially measured at the present value of the lease payments, in its balance sheet. The pronouncement will also require additional disclosures about the amount, timing and uncertainty of cash flows arising from leases. This pronouncement is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018, and early adoption is permitted. Management is currently evaluating the impact of this pronouncement on Lexicon’s consolidated financial statements.

v3.3.1.900
Cash and Cash Equivalents and Investments
12 Months Ended
Dec. 31, 2015
Cash and Cash Equivalents and Investments [Abstract]  
Cash and Cash Equivalents and Investments
Cash and Cash Equivalents and Investments
 
The fair value of cash and cash equivalents and investments held at December 31, 2015 and 2014 are as follows:
 
As of December 31, 2015
 
Amortized Cost
 
Gross Unrealized Gains
 
Gross Unrealized Losses
 
Estimated Fair Value
 
 
 
(in thousands)
 
 
Cash and cash equivalents
$
202,989

 
$

 
$

 
$
202,989

Securities maturing within one year:
 
 
 
 
 
 
 
U.S. treasury securities
313,105

 
2

 
(219
)
 
312,888

Corporate debt securities
5,477

 

 
(2
)
 
5,475

Total short-term investments
$
318,582

 
$
2

 
$
(221
)
 
$
318,363

Total cash and cash equivalents and investments
$
521,571

 
$
2

 
$
(221
)
 
$
521,352

 
 
As of December 31, 2014
 
Amortized Cost
 
Gross Unrealized Gains
 
Gross Unrealized Losses
 
Estimated Fair Value
 
 
 
(in thousands)
 
 
Cash and cash equivalents
$
137,266

 
$

 
$

 
$
137,266

Securities maturing within one year:
 
 
 
 
 
 
 
Certificates of deposit
552

 

 

 
552

U.S. treasury securities
201,584

 
3

 
(66
)
 
201,521

Total short-term investments
$
202,136

 
$
3

 
$
(66
)
 
$
202,073

Total cash and cash equivalents and investments
$
339,402

 
$
3

 
$
(66
)
 
$
339,339



There were no realized gains or losses for the year ended December 31, 2015, no realized gains or losses for the year ended December 31, 2014, and no realized gains or losses for the year ended December 31, 2013.

v3.3.1.900
Fair Value Measurements
12 Months Ended
Dec. 31, 2015
Fair Value Measurements [Abstract]  
Fair Value Measurements
Fair Value Measurements
 
The Company uses various inputs in determining the fair value of its investments and measures these assets on a recurring basis.  Assets and liabilities recorded at fair value in the consolidated balance sheets are categorized by the level of objectivity associated with the inputs used to measure their fair value.  The following levels are directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities:
 
Level 1 – quoted prices in active markets for identical assets, which include U.S. treasury securities
 
Level 2 – other significant observable inputs (including quoted prices for similar investments, market corroborated inputs, etc.), which include corporate debt securities
 
Level 3 – significant unobservable inputs (including the Company’s own assumptions in determining the fair value of the Symphony Icon purchase consideration liability)
 
The inputs or methodology used for valuing securities are not necessarily an indication of the credit risk associated with investing in those securities.  The following tables provide the fair value measurements of applicable Company assets and liabilities that are measured at fair value on a recurring basis according to the fair value levels defined above as of December 31, 2015 and 2014.
 
 
Assets and Liabilities at Fair Value
 
As of December 31, 2015
 
Level 1
 
Level 2
 
Level 3
 
Total
 
(in thousands)
Assets
 
 
 
 
 
 
 
Cash and cash equivalents
$
200,526

 
$
2,463

 
$

 
$
202,989

Short-term investments
312,888

 
5,475

 

 
318,363

Total cash and cash equivalents and investments
$
513,414

 
$
7,938

 
$

 
$
521,352

Liabilities
 
 
 
 
 
 
 
Accrued liabilities
$

 
$

 
$
12,453

 
$
12,453

Other long-term liabilities

 

 
10,362

 
10,362

Total liabilities
$

 
$

 
$
22,815

 
$
22,815



 
Assets and Liabilities at Fair Value
 
As of December 31, 2014
 
Level 1
 
Level 2
 
Level 3
 
Total
 
(in thousands)
Assets
 
 
 
 
 
 
 
Cash and cash equivalents
$
137,266

 
$

 
$

 
$
137,266

Short-term investments
201,521

 
552

 

 
202,073

Total cash and cash equivalents and investments
$
338,787

 
$
552

 
$

 
$
339,339

Liabilities
 
 
 
 
 
 
 
Other long-term liabilities
$

 
$

 
$
17,638

 
$
17,638

Total liabilities
$

 
$

 
$
17,638

 
$
17,638



The Company did not have any Level 3 assets during the years ended December 31, 2015, 2014 and 2013. Transfers between levels are recognized at the actual date of circumstance that caused the transfer. The Company’s Level 3 liabilities represent the contingent purchase consideration payable to Symphony Icon, and are estimated using a probability-based income approach utilizing an appropriate discount rate. Subsequent changes in the fair value of the Symphony Icon (“Symphony Icon”) purchase consideration liability are recorded as an increase or decrease in Symphony Icon purchase liability in the accompanying consolidated statements of comprehensive loss. The fair value of the Symphony Icon purchase consideration liability increased by $5.9 million during the year ended December 31, 2015, increased by $1.4 million during the year ended December 31, 2014, and decreased by $2.2 million during the year ended December 31, 2013. The following table summarizes the change in consolidated balance sheet carrying value associated with Level 3 liabilities for the years ended December 31, 2013, 2014 and 2015.

 
Other Long-term Liabilities
 
(in thousands)
Balance at December 31, 2012
$
29,920

Change in valuation of purchase consideration payable to former Symphony Icon stockholders
(2,210
)
Balance at December 31, 2013
27,710

Change in valuation of purchase consideration payable to former Symphony Icon stockholders
1,428

Payment of base payment obligation with common stock and cash
(11,500
)
Balance at December 31, 2014
17,638

Change in valuation of purchase consideration payable to former Symphony Icon stockholders
5,927

Payment of contingent payment obligation with cash
(750
)
Balance at December 31, 2015
$
22,815



The Company also has assets that under certain conditions are subject to measurement at fair value on a non-recurring basis.  These assets include goodwill associated with the acquisitions of Coelacanth Corporation in 2001 and Symphony Icon in 2010 and intangible assets associated with the acquisition of Symphony Icon in 2010.  For these assets, measurement at fair value in periods subsequent to their initial recognition is applicable if one or more is determined to be impaired.

v3.3.1.900
Buildings and Land for Sale
12 Months Ended
Dec. 31, 2015
Property, Plant and Equipment Impairment or Disposal [Abstract]  
Real Estate Disclosure [Text Block]
Buildings and Land for Sale
 
In 2014, Lexicon reclassified its buildings and land to assets held for sale on the consolidated balance sheet, as it intended to sell these assets. In the fourth quarter of 2015, Lexicon made a change to its plan of sale and reclassified its buildings and land as assets held and used in accordance with the accounting guidance regarding selling assets with a leaseback requirement. The Company estimated the fair value of the net assets to be sold at approximately $20.3 million and $23.8 million as of December 31, 2015 and 2014, respectively, which represents estimated selling price less costs to sell. This resulted in an impairment loss on the buildings of $3.6 million and $13.1 million in the years ended December 31, 2015 and 2014, respectively, which were recorded in impairment loss on buildings in the accompanying consolidated statements of comprehensive loss. The fair value of the net assets to be sold was determined using Level 2 inputs using sales prices in similar real estate sales and offers received from potential purchasers of the building.

In January 2016, Lexicon entered into a Real Estate Purchase and Sale Agreement (“Real Estate Agreement”) with TC Houston Office Development, Inc. (“Purchaser).” Under the Real Estate Agreement, Lexicon agreed to sell its facilities in The Woodlands, Texas to Purchaser for a purchase price of $21.2 million. Such sale is subject to normal and customary closing conditions, including a study period, which extends until March 21, 2016, subject to extension, during which Purchaser may conduct inspections, analyses and other studies of the property and may terminate the Real Estate Agreement in its discretion. Such sale is also subject to the negotiation and execution by the parties of a leaseback agreement with respect to a portion of the property concurrently with closing.

v3.3.1.900
Property and Equipment
12 Months Ended
Dec. 31, 2015
Property and Equipment [Abstract]  
Property and Equipment
Property and Equipment
 
Property and equipment at December 31, 2015 and 2014 are as follows:
 
Estimated Useful Lives
 
As of December 31,
 
In Years
 
2015
 
2014
 
 
 
 
 
(in thousands)
Computers and software
3-5
 
$
8,457

 
$
9,468

Furniture and fixtures
5-7
 
6,269

 
7,032

Laboratory equipment
3-7
 
3,908

 
12,737

Leasehold improvements
7-10
 
240

 
8,117

Buildings
15-40
 
59,117

 

Land
 

 
 
2,664

 

Total property and equipment
 
 
 
 
80,655

 
37,354

Less: Accumulated depreciation and amortization
 
 
 
 
(59,428
)
 
(36,274
)
Net property and equipment
 
 
 
 
$
21,227

 
$
1,080


 
Buildings of $59.1 million and land of $2.7 million, as well as $38.0 million of related accumulated depreciation, have been reclassified to assets held for sale as of December 31, 2014. In 2015, these assets were reclassified to assets held and used, and are therefore disclosed as property and equipment as of December 31, 2015 (see Note 6, Buildings and Land for Sale).

v3.3.1.900
Income Taxes
12 Months Ended
Dec. 31, 2015
Income Taxes [Abstract]  
Income Taxes
Income Taxes
 
Lexicon recognizes deferred tax liabilities and assets for the expected future tax consequences of events that have been recognized differently in the financial statements and tax returns. Under this method, deferred tax liabilities and assets are determined based on the difference between the financial statement carrying amounts and tax bases of liabilities and assets using enacted tax rates and laws in effect in the years in which the differences are expected to reverse. Deferred tax assets are evaluated for realization based on a more-likely-than-not criteria in determining if a valuation allowance should be provided.
 
The components of Lexicon’s deferred tax assets (liabilities) at December 31, 2015 and 2014 are as follows:
 
 
As of December 31,
 
2015
 
2014
 
(in thousands)
Deferred tax assets:
 
 
 
Net operating loss carryforwards
$
263,138

 
$
255,518

Research and development tax credits
43,728

 
40,173

Capitalized research and development
85,385

 
95,946

Stock-based compensation
8,160

 
7,648

Deferred revenue
4,363

 
4,457

Other
8,831

 
8,681

Total deferred tax assets
413,605

 
412,423

Deferred tax liabilities:
 
 
 
Deferred tax liability related to acquisition of Symphony Icon
(18,675
)

(18,675
)
Total deferred tax liabilities
(18,675
)
 
(18,675
)
Less: valuation allowance
(413,605
)
 
(412,423
)
Net deferred tax liabilities
$
(18,675
)
 
$
(18,675
)


The $18.7 million deferred tax liability relates to the tax impact of future amortization or possible impairments associated with intangible assets acquired with Symphony Icon, which are not deductible for tax purposes. Lexicon does not believe it can estimate the reversal of the temporary difference related to the assets acquired with sufficient certainty such that the related deferred tax liability could be considered as a source of taxable income in assessing the Company’s need for a valuation allowance.

At December 31, 2015, Lexicon had both federal and state NOL carryforwards of approximately $738.0 million and $455.1 million, respectively.  The federal and state NOL carryforwards began to expire in 2011 and continued to expire in 2012.  The Company’s R&D tax credit carryforwards of approximately $43.7 million began to expire in 2012.  Utilization of the NOL and R&D credit carryforwards may be subject to a significant annual limitation due to ownership changes that have occurred previously or could occur in the future provided by Section 382 of the Internal Revenue Code.  Based on the federal tax law limits and the Company’s cumulative loss position, Lexicon concluded it was appropriate to establish a full valuation allowance for its net deferred tax assets until an appropriate level of profitability is sustained.  During the year ended December 31, 2015, the valuation allowance increased $1.2 million, primarily due to the Company’s current year net loss.  Lexicon recorded income tax benefits of $0, $70,000 and $0 in the years ended December 31, 2015, 2014 and 2013, respectively. As of December 31, 2015 and 2014, the Company did not have any unrecognized tax benefits.
 
The Company is primarily subject to U.S. federal and New Jersey and Texas state income taxes.  The tax years 1995 to current remain open to examination by U.S. federal authorities and 2004 to current remain open to examination by state authorities.  The Company’s policy is to recognize interest and penalties related to income tax matters in income tax expense.  As of December 31, 2015 and 2014, the Company had no accruals for interest or penalties related to income tax matters.

v3.3.1.900
Goodwill
12 Months Ended
Dec. 31, 2015
Goodwill [Abstract]  
Goodwill
Goodwill
 
On July 12, 2001, Lexicon completed the acquisition of Coelacanth Corporation in a merger. Coelacanth, now Lexicon Pharmaceuticals (New Jersey), Inc., formed the core of the Company’s division responsible for small molecule compound discovery.  The results of Lexicon Pharmaceuticals (New Jersey), Inc. are included in the Company’s results of operations for the period subsequent to the acquisition. Goodwill associated with the acquisition of $25.8 million, which represents the excess of the $36.0 million purchase price over the fair value of the underlying net identifiable assets, was assigned to the consolidated entity, Lexicon.  

On July 30, 2010, Lexicon exercised its Purchase Option (as defined in Note 11) and completed the acquisition of Symphony Icon. Goodwill associated with the acquisition of $18.7 million, which represents the assets recognized in connection with the deferred tax liability acquired and did not result from excess purchase price, was assigned to the consolidated entity, Lexicon.

Goodwill is not subject to amortization, but is tested at least annually for impairment at the reporting unit level, which is the Company’s single operating segment.  The Company performed an impairment test of goodwill on its annual impairment assessment date.  This test did not result in an impairment of goodwill.

v3.3.1.900
Debt Obligations
12 Months Ended
Dec. 31, 2015
Debt Obligations [Abstract]  
Debt Obligations
Debt Obligations
 
Convertible Debt. In November 2014, Lexicon completed an offering of $87.5 million in aggregate principal amount of its 5.25% Convertible Senior Notes due 2021 (the “Notes”). The conversion feature did not meet the criteria for bifurcation as required by generally accepted accounting principles and the entire principal amount was recorded as long-term debt on the Company’s consolidated balance sheets.

The Notes are governed by an indenture (the “Indenture”), dated as of November 26, 2014, between the Company and Wells Fargo Bank, N.A., as trustee. The Notes bear interest at a rate of 5.25% per year, payable semiannually in arrears on June 1 and December 1 of each year, beginning on June 1, 2015. The Notes mature on December 1, 2021. The Company may not redeem the Notes prior to the maturity date, and no sinking fund is provided for the Notes.

Holders of the Notes may convert their Notes at their option at any time prior to the close of business on the business day immediately preceding the maturity date. Upon conversion, the Company will deliver for each $1,000 principal amount of converted Notes a number of shares of its common stock equal to the conversion rate, as described in the Indenture. The conversion rate is initially 118.4553 shares of common stock per $1,000 principal amount of Notes (equivalent to an initial conversion price of $8.442 per share of common stock). The conversion rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date, the Company will increase the conversion rate for a holder who elects to convert its Notes in connection with such a corporate event in certain circumstances.

If the Company undergoes a fundamental change, holders may require the Company to repurchase for cash all or any portion of their Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.

In connection with the issuance of the Notes, the Company incurred $3.4 million of debt issuance costs, which is included in other assets on the consolidated balance sheets. The debt issuance costs are amortized as interest expense over the expected life of the Notes using the effective interest method. The Company determined the expected life of the debt was equal to the seven-year term of the Notes. As of December 31, 2015, the balance of unamortized debt issuance costs was $2.8 million.

The fair value of the Notes was $154.2 million as of December 31, 2015 and was determined using Level 2 inputs based on the indicative pricing published by certain investment banks or trading levels of the Notes, which are not listed on any securities exchange or quoted on an inter-dealer automated quotation system.

Mortgage Loan. In April 2004, Lexicon purchased its existing laboratory and office buildings and animal facilities in The Woodlands, Texas with proceeds from a $34.0 million third-party mortgage financing and $20.8 million in cash.  The mortgage loan originally had a ten-year term with a 20-year amortization and a fixed interest rate of 8.23%. The mortgage was amended in September 2013 to extend the maturity date from April 2014 to April 2017, with the mortgage loan’s monthly payment amount and fixed interest rate each remaining unchanged. The mortgage had a principal balance of $18.3 million as of December 31, 2015. This entire balance was classified as current liabilities on the accompanying consolidated balance sheet as of December 31, 2014 as management intended to repay the mortgage when the assets that serve as collateral for the mortgage loan were sold, and those assets were classified as held for sale as of December 31, 2014. In 2015, these assets were reclassified to assets held and used, and are therefore disclosed as property and equipment as of December 31, 2015, and the related mortgage was reclassified to long-term liabilities, to the extent it is scheduled to be paid after one year, assuming the purchase and sale agreement is not completed (see Note 6, Buildings and Land for Sale). If the purchase and sale agreement that is discussed in Note 6 is completed, the mortgage will be repaid immediately. The buildings and land that serve as collateral for the mortgage loan are included in assets held for sale at $59.1 million and $2.7 million, respectively, before accumulated depreciation, as of December 31, 2015. The fair value of Lexicon’s mortgage loan approximates its carrying value.  The fair value of Lexicon’s mortgage loan was determined using Level 2 inputs using discounted cash flow analysis, based on the Company’s estimated current incremental borrowing rate.

The following table includes the aggregate scheduled future principal payments of the Company’s long-term debt as of December 31, 2015:
 
 
For the Year Ending
December 31
 
(in thousands)
2016
$
2,015

2017
16,293

2018

2019

2020

Thereafter
87,500

Total debt
105,808

Less current portion
(2,015
)
Total long-term debt
$
103,793


v3.3.1.900
Arrangements with Symphony Icon, Inc.
12 Months Ended
Dec. 31, 2015
Arrangements with Symphony Icon Inc [Abstract]  
Arrangements with Symphony Icon, Inc.
Arrangements with Symphony Icon, Inc.
 
On June 15, 2007, Lexicon entered into a series of related agreements providing for the financing of the clinical development of certain of its drug candidates, including telotristat etiprate (LX1032) and LX1033, along with any other pharmaceutical compositions modulating the same targets as those drug candidates (the “Programs”). The agreements included a Novated and Restated Technology License Agreement pursuant to which the Company licensed to Symphony Icon, a then wholly-owned subsidiary of Symphony Icon Holdings LLC (“Holdings”), the Company’s intellectual property rights related to the Programs. Holdings contributed $45 million to Symphony Icon in order to fund the clinical development of the Programs.
Under a Share Purchase Agreement, dated June 15, 2007, between the Company and Holdings, the Company issued and sold to Holdings 1,092,946 shares of its common stock on June 15, 2007 in exchange for $15 million and an exclusive purchase option (the “Purchase Option”) that gave the Company the right to acquire all of the equity of Symphony Icon, thereby allowing the Company to reacquire all of the Programs. On July 30, 2010, Lexicon entered into an Amended and Restated Purchase Option Agreement with Symphony Icon and Holdings and simultaneously exercised the Purchase Option, thereby reacquiring the Programs. Pursuant to the amended terms of the Purchase Option, Lexicon paid Holdings $10 million on July 30, 2010 and issued 1,891,074 shares of common stock to designees of Holdings on July 30, 2012 in satisfaction of an additional $35.0 million base payment obligation.
Lexicon also agreed to make up to $45 million in additional contingent payments, which will consist of 50% of any consideration Lexicon receives pursuant to any licensing transaction (a “Licensing Transaction”) under which Lexicon grants a third party rights to commercialize telotristat etiprate, LX1033 or other pharmaceutical compositions modulating the same target as those drug candidates (the “LG103 Programs”), subject to certain exceptions. The contingent payments will be due if and when Lexicon receives such consideration from a Licensing Transaction. In the event Lexicon receives regulatory approval in the United States for the marketing and sale of any product resulting from the LG103 Programs prior to entering into a Licensing Transaction for the commercialization of such product in the United States, in lieu of any contingent payment from such a Licensing Transaction, Lexicon will pay Holdings the sum of $15 million and the amount of certain expenses Lexicon incurred after its exercise of the Purchase Option which are attributable to the development of such product, reduced by up to 50% of such sum on account of any contingent payments paid prior to such United States regulatory approval attributable to any such Licensing Transaction outside of the United States with respect to such product. In the event Lexicon makes any such payment upon United States regulatory approval, Lexicon will have no obligation to make subsequent contingent payments attributable to any such Licensing Transactions for the commercialization of such product outside the United States until the proceeds of such Licensing Transactions exceed 50% of the payment made as a result of such United States regulatory approval. The contingent payments may be paid in cash or a combination of cash and common stock, in Lexicon’s discretion, provided that no more than 50% of any contingent payment will be paid in common stock. On December 4, 2014, Lexicon paid $5.8 million in cash and issued 666,111 shares of common stock to designees of Holdings in satisfaction of a $11.5 million contingent payment obligation as a result of receiving an upfront payment pursuant to Lexicon’s license and collaboration agreement with Ipsen Pharma SAS. On April 24, 2015, Lexicon paid $0.75 million in cash to Holdings in satisfaction of its contingent payment obligation as a result of receiving an additional upfront payment from Ipsen in March 2015 (see Note 16, Collaboration and License Agreements).

Lexicon accounted for the exercise of the Purchase Option and acquisition of Symphony Icon as a business combination. In connection with its acquisition of Symphony Icon, Lexicon paid $10.0 million in cash, and has also agreed to pay Holdings additional base and contingent payments as discussed above. The fair value of the base and contingent consideration payments was $45.6 million and was estimated by applying a probability-based income approach utilizing an appropriate discount rate. This estimation was based on significant inputs that are not observable in the market, referred to as Level 3 inputs. Key assumptions include: (1) a discount rate of 14% for the base payments; (2) a discount rate of 18% for the contingent payments; and (3) a probability adjusted contingency. The discount rate assumptions have not changed through December 31, 2015, and as programs progress, the probability adjusted contingency is adjusted as necessary. Subsequent changes in the fair value of the Symphony Icon purchase consideration liability are recorded as increase or decrease in fair value of Symphony Icon purchase liability expense in the accompanying consolidated statements of comprehensive loss. The fair value of the Symphony Icon purchase consideration liability increased by $5.9 million during the year ended December 31, 2015, increased by $1.4 million during the year ended December 31, 2014, and decreased by $2.2 million during the year ended December 31, 2013. In August 2015, Lexicon announced that the pivotal TELESTAR Phase 3 clinical trial met its primary endpoint, showing the benefit of oral telotristat etiprate in treating cancer patients with carcinoid syndrome that is not adequately controlled by the current standard of care. The increase in the contingent purchase liability during the year ended December 31, 2015 reflects a greater likelihood following the top-line results from the TELESTAR trial that the Company will achieve certain milestones with telotristat etiprate, such as regulatory approval, that would trigger payments under the contingent liability.

v3.3.1.900
Commitments and Contingencies
12 Months Ended
Dec. 31, 2015
Commitments and Contingencies [Abstract]  
Commitments and Contingencies
Commitments and Contingencies
 
Operating Lease Obligations:  A Lexicon subsidiary leases office space in Basking Ridge, New Jersey under a lease agreement, the term of which began in June 2015 and terminates in December 2022. Rent expense is recognized on a straight-line basis over the lease term.  Lexicon is the guarantor of the obligations of its subsidiary under this lease agreement.  Under a lease that expired in June 2015, the Company was required to maintain restricted investments to collateralize a standby letter of credit for this lease.  The Company had $0.0 million and $0.4 million in restricted investments as collateral as of December 31, 2015 and 2014, respectively.  Additionally, Lexicon leases certain equipment under operating leases.
 
Rent expense for all operating leases was approximately $0.1 million, $1.0 million and $0.9 million for the years ended December 31, 2015, 2014 and 2013, respectively.  The following table includes non-cancelable, escalating future lease payments for the facility in New Jersey:
 
 
For the Year Ending
December 31
 
(in thousands)
2016
$
512

2017
582

2018
595

2019
607

2020
620

Thereafter
1,277

Total
$
4,193



Employment Arrangements: Lexicon has entered into employment arrangements with certain of its corporate officers. Under the arrangements, each officer receives a base salary, subject to adjustment, with an annual discretionary bonus based upon specific objectives to be determined by the compensation committee. The employment arrangements are at-will and some contain non-competition agreements. Some of the arrangements also provide for certain severance payments for either six or 12 months and, in some cases, payment of a specified portion of the officer’s bonus target for such year, in the event of a specified termination of the officer’s employment.
 
Legal Proceedings:  Lexicon is from time to time party to claims and legal proceedings that arise in the normal course of its business and that it believes will not have, individually or in the aggregate, a material adverse effect on its results of operations, financial condition or liquidity.

v3.3.1.900
Other Capital Stock Agreements
12 Months Ended
Dec. 31, 2015
Other Capital Stock Agreements [Abstract]  
Other Capital Stock Agreements
Other Capital Stock Agreements
 
Common Stock: In November 2014, Lexicon sold 7,944,133 shares of its common stock at a price of $7.035 per share in a public offering, and sold 21,321,961 shares of its common stock at a price of $7.035 per share in a private placement to Artal International S.C.A, an affiliate of Invus, L.P., Lexicon’s largest stockholder, resulting in net proceeds of $201.9 million, after deducting underwriting discounts and commissions of $3.4 million and offering expenses of $0.6 million. All of the net proceeds of these offerings are reflected as issuance of common stock in the accompanying financial statements.

Reverse Stock Split: Effective May 20, 2015, Lexicon completed a one-for-seven reverse split of its common stock. All references to shares of common stock and per-share data for all periods presented in this report have been adjusted to give effect to this reverse stock split. Proportional adjustments were also made to all shares of common stock issuable under Lexicon’s equity incentive plans and upon conversion of Lexicon’s Notes. Concurrent with the reverse stock split, the authorized shares of common stock were reduced from 900 million (prior to the reverse stock split) to 225 million. As no change was made to the par value of the common shares, common stock and additional paid-in capital were adjusted on a retroactive basis to give effect to the reverse stock split. No fractional shares were issued in connection with the reverse stock split. Any fractional share of common stock that would otherwise have resulted from the reverse stock split were converted into cash payments equal to such fraction multiplied by the closing sales price of the common stock as last reported on the last trading day immediately preceding the effective date of the reverse stock split.

v3.3.1.900
Equity Incentive Awards
12 Months Ended
Dec. 31, 2015
Equity Incentive Awards [Abstract]  
Equity Incentive Awards
Equity Incentive Awards
 
Equity Incentive Plans
 
Equity Incentive Plan:  In September 1995, Lexicon adopted the 1995 Stock Option Plan, which was subsequently amended and restated in February 2000, April 2009, April 2012 and April 2015 and renamed the Equity Incentive Plan (the “Equity Incentive Plan”).
 
The Equity Incentive Plan provides for the grant of incentive stock options to employees and nonstatutory stock options to employees, directors and consultants of the Company. The plan also permits the grant of stock bonus awards, restricted stock awards, restricted stock unit (phantom stock) awards and stock appreciation rights. Incentive and nonstatutory stock options have an exercise price of 100% or more of the fair market value of our common stock on the date of grant.  The purchase price of restricted stock awards may not be less than 85% of fair market value.  However, the plan administrator may award stock bonus awards in consideration of past services or phantom stock awards without a purchase payment. Shares may be subject to a repurchase option in the discretion of the plan administrator.  Most options granted under the Equity Incentive Plan become vested and exercisable over a period of four years; however some have been granted with different vesting schedules.  Options granted under the Equity Incentive Plan have a term of ten years from the date of grant.
 
The total number of shares of common stock that may be issued pursuant to stock awards under the Equity Incentive Plan shall not exceed in the aggregate 10,000,000 shares.  No more than 3,571,428 shares may be issued pursuant to awards other than stock options and stock appreciation rights.  As of December 31, 2015, an aggregate of 10,000,000 shares of common stock had been reserved for issuance, options to purchase 4,046,758 shares and 636,906 restricted stock units were outstanding, 858,875 shares had been issued upon the exercise of stock options, 626,839 shares had been issued pursuant to restricted stock units and 113,940 shares had been issued pursuant to stock bonus awards or restricted stock awards granted under the Equity Incentive Plan.

Non-Employee Directors’ Equity Incentive Plan:  In February 2000, Lexicon adopted the 2000 Non-Employee Directors’ Stock Option Plan, which was subsequently amended and restated in April 2009, April 2012 and April 2015 and renamed the Non-Employee Directors’ Equity Incentive Plan (the “Directors’ Plan”).  Under the Directors’ Plan, non-employee directors receive an initial option to purchase 4,285 shares of common stock.  In addition, on the day following each of the Company’s annual meetings of stockholders, each non-employee director who has been a director for at least six months is automatically granted an option to purchase 2,857 shares of common stock and a restricted stock award of the number of shares of common stock having a fair market value on the date of grant of $20,000, rounded down to the nearest whole share number.  Initial option grants become vested and exercisable over a period of five years and annual option grants become vested over a period of 12 months from the date of grant.  Options granted under the Directors’ Plan have an exercise price equal to the fair market value of the Company’s common stock on the date of grant and a term of ten years from the date of grant.
 
The total number of shares of common stock that may be issued pursuant to stock awards under the Directors’ Plan shall not exceed in the aggregate 357,142 shares.  As of December 31, 2015, an aggregate of 357,142 shares of common stock had been reserved for issuance, options to purchase 169,971 shares were outstanding, none had been issued upon the exercise of stock options and 60,992 shares had been issued pursuant to restricted stock awards granted under the Directors’ Plan.

Stock Option Activity:  The following is a summary of option activity under Lexicon’s equity incentive plans:
 
 
2015
 
2014
 
2013
(in thousands, except exercise price data)
 
Options
 
Weighted Average Exercise Price
 
Options
 
Weighted Average Exercise Price
 
Options
 
Weighted Average Exercise Price
Outstanding at beginning of year
 
3,371

 
$
14.98

 
3,329

 
$
16.94

 
3,075

 
$
17.57

Granted
 
1,207

 
6.83

 
643

 
11.76

 
499

 
14.91

Exercised
 
(19
)
 
11.14

 
(32
)
 
10.22

 
(82
)
 
12.25

Expired
 
(187
)
 
27.29

 
(476
)
 
24.78

 
(136
)
 
27.86

Forfeited
 
(155
)
 
8.51

 
(93
)
 
13.79

 
(27
)
 
13.58

Outstanding at end of year
 
4,217

 
12.35

 
3,371

 
14.98

 
3,329

 
16.94

Exercisable at end of year
 
2,686

 
$
14.53

 
2,417

 
$
15.89

 
2,483

 
$
17.92



The weighted average estimated grant date fair value of options granted during the years ended December 31, 2015, 2014 and 2013 were $4.58, $8.61 and $11.13, respectively.  The total intrinsic value of options exercised during the years ended December 31, 2015, 2014 and 2013 were $35,000, $43,000 and $325,000, respectively.  The weighted average remaining contractual term of options outstanding and exercisable was 6.1 and 4.5 years, respectively, as of December 31, 2015.  At December 31, 2015, the aggregate intrinsic value of the outstanding options and the exercisable options was $10.0 million and $2.4 million, respectively.

Stock Bonus and Restricted Stock Unit Activity:
     
During the years ended December 31, 2015, 2014 and 2013, Lexicon granted its non-employee directors 21,360, 14,651 and 11,544 shares, respectively, of restricted stock awards. The restricted stock awards had weighed average grant date fair values of $7.49, $10.92 and $13.86 per share, respectively, and vested immediately. During the year ended December 31, 2014, Lexicon granted a consultant 8,200 shares of restricted stock awards. The restricted stock awards had a weighted average grant date fair value of $11.20 per share and vested immediately.

During the years ended December 31, 2015, 2014 and 2013, Lexicon granted its employees restricted stock units in lieu of or in addition to annual stock option awards. These restricted stock units vest in four annual installments. The following is a summary of restricted stock units activity under Lexicon’s stock-based compensation plans for the year ended December 31, 2015:
 
 
Shares
 
Weighted Average Grant Date Fair Value
 
 
(in thousands)
 
 
Outstanding at December 31, 2014
 
447

 
$
12.88

Granted
 
452

 
6.23

Vested
 
(166
)
 
12.91

Forfeited
 
(96
)
 
8.98

Nonvested at December 31, 2015
 
637

 
$
8.74



Aggregate Shares Reserved for Issuance
 
As of December 31, 2015, an aggregate of 4,853,635 shares of common stock were reserved for issuance upon exercise of outstanding stock options and vesting of outstanding restricted stock units and 3,842,861 additional shares were available for future grants under Lexicon’s equity incentive plans.  The Company has a policy of using either authorized and unissued shares or treasury shares, including shares acquired by purchase in the open market or in private transactions, to satisfy equity award exercises.

v3.3.1.900
Benefit Plan
12 Months Ended
Dec. 31, 2015
Benefit Plan [Abstract]  
Benefit Plan
Benefit Plan
  
Lexicon maintains a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code.  The plan covers substantially all full-time employees.  Participating employees may defer a portion of their pretax earnings, up to the Internal Revenue Service annual contribution limit.  Beginning in 2000, the Company was required to match employee contributions according to a specified formula.  The matching contributions totaled $332,000, $376,000 and $511,000 in the years ended December 31, 2015, 2014 and 2013, respectively.  Company contributions are vested based on the employee’s years of service, with full vesting after four years of service.

v3.3.1.900
Collaboration and License Agreements
12 Months Ended
Dec. 31, 2015
Collaboration and License Agreements [Abstract]  
Collaboration and License Agreements
Collaboration and License Agreements
 
Lexicon has derived substantially all of its revenues from drug discovery and development alliances, target validation collaborations for the development and, in some cases, analysis of the physiological effects of genes altered in knockout mice, government grants and contracts, technology licenses, subscriptions to its databases and compound library sales.

Sanofi. In November 2015, Lexicon entered into a Collaboration and License Agreement (the “Sanofi Agreement”) with Sanofi for the worldwide development of Lexicon’s drug candidate sotagliflozin (LX4211).

Under the Sanofi Agreement, Lexicon granted Sanofi an exclusive, worldwide, royalty-bearing right and license under its patent rights and know-how to develop, manufacture and commercialize sotagliflozin. Subject to specified exceptions, neither party may (a) perform clinical development activities relating to any other compound which inhibits sodium-glucose cotransporters type 1 or type 2 or (b) commercialize any such compounds in the United States, countries of the European Union and certain other specified countries, in each case during the royalty terms applicable in such countries. Among the specified exceptions is a right Lexicon retained to pursue the development of its LX2761 drug candidate, with respect to which Lexicon granted Sanofi certain rights of first negotiation specified in the Sanofi Agreement.

Under the Sanofi Agreement, Sanofi paid Lexicon an upfront payment of $300 million. In addition, Lexicon is eligible to receive from Sanofi (a) up to an aggregate of $430 million upon the achievement of specified development and regulatory milestones and (b) up to an aggregate of $990 million upon the achievement of specified sales milestones. Due to the uncertainty surrounding the achievement of the future development, regulatory and sales milestones, these payments will not be recognized as revenue unless and until they are earned as the Company is not able to reasonably predict if and when the milestones will be achieved. Lexicon is also entitled to tiered, escalating royalties ranging from low double digit percentages to forty percent of net sales of sotagliflozin, based on indication and territory, with royalties for the higher band of such range attributable to net sales for type 1 diabetes in the United States, and subject in each case to customary royalty reduction provisions. Royalties payable with respect to net sales of sotagliflozin for type 1 diabetes in the United States will also be reduced in the event Lexicon does not exercise its co-promotion option described below.

Lexicon will continue to be responsible for all clinical development activities relating to type 1 diabetes and will retain an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the United States. If Lexicon exercises its co-promotion option, Lexicon will fund forty percent of the commercialization costs relating to such co-promotion activities. Sanofi will be responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide and will be solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the United States. Lexicon will share in the funding of a portion of the planned type 2 diabetes development costs over the next three years, up to an aggregate of $100 million. Sanofi will book sales worldwide in all indications.

The parties are responsible for using commercially reasonable efforts to perform their development and commercialization obligations pursuant to mutually approved development and commercialization plans.

The parties’ activities under the Sanofi Agreement are governed by a joint steering committee and certain other governance committees which reflect equal or other appropriate representation from both parties. If the applicable governance committee is not able to make a decision by consensus and the parties are not able to resolve the issue through escalation to specified senior executive officers of the parties, then Sanofi will have final decision-making authority, subject to limitations specified in the Sanofi Agreement.

The Sanofi Agreement will expire upon the expiration of all applicable royalty terms for all licensed products in all countries. The royalty term for each licensed product in each country is the period commencing on the effective date of the Sanofi Agreement and ending on the latest of expiration of specified patent coverage, expiration of specified regulatory exclusivity and 10 years following the first commercial sale in the applicable country. Either party may terminate the Sanofi Agreement in the event of an uncured material breach by the other party. Prior to completion of the core development activities for type 2 diabetes specified in the development plan, Sanofi may terminate the Sanofi Agreement on a country-by-country and licensed product-by-licensed product basis, in the event of (a) notification of a material safety issue relating to the licensed product or the class of sodium-glucose cotransporters type 1 or type 2 inhibitors resulting in a recommendation or requirement that Lexicon or Sanofi cease development, (b) failure to achieve positive results with respect to certain clinical trial results, (c) the occurrence of specified fundamental adverse events or (d) the exploitation of the licensed product infringing third party intellectual property rights in specified major markets and Sanofi is unable to obtain a license to such third party intellectual property rights.

The Company considered the following deliverables with respect to the revenue recognition of the $300 million upfront payment:

The exclusive worldwide license granted to Sanofi to develop and commercialize sotagliflozin;
The development services Lexicon is performing for sotagliflozin relating to type 1 diabetes; and
The funding Lexicon will provide for development relating to type 2 diabetes.

The Company determined that the license had stand-alone value because it is an exclusive license that gives Sanofi the right to develop and commercialize sotagliflozin or to sublicense its rights. In addition, sotagliflozin is currently in development and it is possible that Sanofi or another third party could conduct clinical trials without assistance from Lexicon. As a result, the Company considers the license and the development services under the Sanofi Agreement to be separate units of accounting. The Company recognized the portion of the consideration allocated to the license immediately because Lexicon delivered the license and earned the revenue at the inception of the arrangement. The Company is recognizing as revenue the amount allocated to the development services for type 1 diabetes and the obligation to provide funding for development services for type 2 diabetes over the period of time Lexicon performs services or provides funding, currently expected to be through 2020.

The Company determined that the initial allocable arrangement consideration was the $300 million upfront payment because it was the only payment that was fixed and determinable at the inception of the arrangement. There was considerable uncertainty at the date of the agreement as to whether Lexicon would earn milestone payments or royalty payments. As such, the Company did not include those payments in the allocable consideration. The Company allocated the allocable consideration based on the relative best estimate of selling price of each unit of accounting. The Company estimated the selling price of the license deliverable by applying a probability-based income approach utilizing an appropriate discount rate. The significant inputs the Company used to determine the projected income of the license included: exercising the option to co-promote, estimated future product sales, estimated cost of goods sold, estimated operating expenses, income taxes, and an appropriate discount rate. The Company estimated the selling price of the development services for type 1 diabetes by using internal estimates of the cost to hire third parties to perform the services over the expected period to perform the development. The Company estimated the obligation to provide funding for type 2 diabetes by using internal estimates of the expected cash flows and timing for $100 million in funding.

As a result of the allocation, the Company recognized $126.8 million of the $300 million upfront payment for the license in the year ended December 31, 2015. The Company is recognizing the $113.8 million allocated to the development services deliverable and the $59.4 million allocated to the funding deliverable over the estimated period of performance as the development and funding occurs. Revenue recognized under the Sanofi Agreement was $126.8 million for the year ended December 31, 2015.
 
Ipsen Pharma SAS. In October 2014, Lexicon entered into a License and Collaboration Agreement, which was subsequently amended in March 2015 (collectively, the “Ipsen Agreement”), with Ipsen Pharma SAS (“Ipsen”) for the development and commercialization of Lexicon’s drug candidate telotristat etiprate (LX1032) outside of the United States and Japan (the “Licensed Territory”).

Under the Ipsen Agreement, Lexicon granted Ipsen an exclusive, royalty-bearing right and license under its patent rights and know-how to commercialize telotristat etiprate in the Licensed Territory. Ipsen is responsible for using diligent efforts to commercialize telotristat etiprate in the Licensed Territory pursuant to a mutually approved commercialization plan. Subject to certain exceptions, Lexicon will be responsible for conducting clinical trials required to obtain regulatory approval for telotristat etiprate for carcinoid syndrome in the European Union, including those contemplated by a mutually approved initial development plan, and will have the first right to conduct most other clinical trials of telotristat etiprate. Lexicon is responsible for the costs of all clinical trials contemplated by the initial development plan. The costs of additional clinical trials will be allocated between the parties based on the nature of such clinical trials. Under the Ipsen Agreement, Ipsen has paid Lexicon an aggregate of $24.5 million through December 31, 2015. In addition, Lexicon is eligible to receive from Ipsen (a) up to an aggregate of approximately $34 million upon the achievement of specified regulatory and commercial launch milestones and (b) up to an aggregate of €72 million upon the achievement of specified sales milestones. Due to the uncertainty surrounding the achievement of the future regulatory and sales milestones, these payments will not be recognized as revenue unless and until they are earned as the Company is not able to reasonably predict if and when the milestones will be achieved. Lexicon is also entitled to tiered, escalating royalties ranging from low twenties to mid-thirties percentages of net sales of telotristat etiprate in the Licensed Territory, subject to a credit for amounts previously paid to Lexicon by Ipsen for the manufacture and supply of such units of telotristat etiprate. Lexicon’s receipt of these payments under the Ipsen Agreement triggers its obligation to make certain contingent payments to Holdings (see Note 11, Arrangements with Symphony Icon, Inc.). Lexicon and Ipsen will enter into a commercial supply agreement pursuant to which Lexicon will supply Ipsen’s commercial requirements of telotristat etiprate, and Ipsen will pay an agreed upon transfer price for such commercial supply.

The Company considered the following deliverables with respect to the revenue recognition of the $24.5 million upfront payment:

The exclusive license granted to Ipsen to develop and commercialize telotristat etiprate in the Licensed
Territory;
The development services Lexicon is performing for telotristat etiprate;
The obligation to participate in committees which govern the development of telotristat
etiprate until commercialization; and
The obligation to supply commercial supply of telotristat etiprate, under a commercial supply agreement.

The Company determined that the license had stand-alone value because it is an exclusive license that gives Ipsen the right to develop and commercialize telotristat etiprate or to sublicense its rights. In addition, telotristat etiprate is currently in development and it is possible that Ipsen or another third party could conduct clinical trials without assistance from Lexicon. As a result, the Company considers the license and the development services under the Agreement to be separate units of accounting. The Company recognized the portion of the consideration allocated to the license immediately because Lexicon delivered the license and earned the revenue at the inception of the arrangement. The Company is recognizing as revenue the amount allocated to the development services and the obligation to participate in committees over the period of time Lexicon performs services, currently expected to be through mid-2017.

Due to the inherent uncertainty in obtaining regulatory approval, the applicability of the commercial supply agreement is outside the control of Lexicon and Ipsen. Accordingly, the Company has determined the commercial supply agreement is a contingent deliverable at the onset of the Agreement. As a result, the Company has determined the commercial supply agreement does not meet the definition of a deliverable that needs to be accounted for at the inception of the arrangement. The Company has also determined that there is no significant and incremental discount related to the commercial supply agreement that should be accounted for at the inception of the arrangement.

The Company determined that the initial allocable arrangement consideration was the $24.5 million upfront payments because they were the only payments that were fixed and determinable at the inception of the arrangement. There was considerable uncertainty at the date of the agreement as to whether Lexicon would earn milestone payments, royalty payments or payments for finished drug product. As such, the Company did not include those payments in the allocable consideration. The Company allocated the allocable consideration based on the relative best estimate of selling price of each unit of accounting. The Company estimated the selling price of the license deliverable by applying a probability-based income approach utilizing an appropriate discount rate. The significant inputs the Company used to determine the projected income of the license included: estimated future product sales, estimated cost of goods sold, estimated operating expenses, income taxes, and an appropriate discount rate. The Company estimated the selling price of the development services by using internal estimates of the cost to hire third parties to perform the services over the expected period to perform the development. The Company estimated the selling price of the obligation to participate in committees by using internal estimates of the number of internal hours and salary and benefits costs to perform these services.

As a result of the allocation, the Company recognized $21.2 million of the $24.5 million upfront payment for the license in 2014, and an additional $1.4 million in 2015 upon entering into the amendment. The Company is recognizing the $1.7 million allocated to the development services deliverable over the estimated period of performance as development occurs, and is recognizing the $0.1 million allocated to the committee participation deliverable ratably over the estimated period of performance. Revenue recognized under the Agreement was $2.3 million and $21.4 million for the years ended December 31, 2015 and 2014, respectively.
 
Texas Institute for Genomic Medicine.   In July 2005, Lexicon received a $35.0 million award from the Texas Enterprise Fund for the creation of a knockout mouse embryonic stem cell library containing 350,000 cell lines for the Texas Institute for Genomic Medicine (“TIGM”) using Lexicon’s proprietary gene trapping technology, which Lexicon completed in 2007.  Lexicon also equipped TIGM with the bioinformatics software required for the management and analysis of data relating to the library.  The Texas Enterprise Fund also awarded $15.0 million to the Texas A&M University System for the creation of facilities and infrastructure to house the library.  
 
Under the terms of the award, Lexicon is responsible for the creation of a specified number of jobs beginning in 2012, reaching an aggregate of 1,616 new jobs in Texas by December 31, 2016.  Lexicon will obtain credits based on funding received by TIGM and certain related parties from sources other than the State of Texas that it may offset against its potential liability for any job creation shortfalls.  Lexicon will also obtain credits against future jobs commitment liabilities for any surplus jobs it creates.  Subject to these credits, if Lexicon fails to create the specified number of jobs, the state may require Lexicon to repay $2,415 for each job Lexicon falls short beginning in 2013.  Lexicon’s maximum aggregate exposure for such payments, if Lexicon fails to create any new jobs, is approximately $14.2 million, including $6.4 million through 2016, without giving effect to any credits to which Lexicon may be entitled.  Lexicon has recorded this obligation as deferred revenue and accounts payable in the accompanying consolidated balance sheets.  The Texas A&M University System, together with TIGM, has independent job creation obligations and is obligated for an additional period to maintain an aggregate of 5,000 jobs, inclusive of those Lexicon creates.

v3.3.1.900
Selected Quarterly Financial Data
12 Months Ended
Dec. 31, 2015
Selected Quarterly Financial Data [Abstract]  
Selected Quarterly Financial Data
Selected Quarterly Financial Data (Unaudited)
 
The table below sets forth certain unaudited statements of comprehensive loss data, and net loss per common share data, for each quarter of 2015 and 2014:
 
(in thousands, except per share data)
 
Quarter Ended
 
March 31
 
June 30
 
September 30
 
December 31
 
 
 
(Unaudited)
 
 
2015
 

 
 

 
 

 
 

Revenues
$
1,792

 
$
376

 
$
566

 
$
127,280

Income (loss) from operations
$
(26,527
)
 
$
(26,688
)
 
$
(33,677
)
 
$
88,360

Consolidated net income (loss)
$
(28,076
)
 
$
(26,074
)
 
$
(35,282
)
 
$
86,750

Consolidated net income (loss) per common share, basic
$
(0.27
)
 
$
(0.27
)
 
$
(0.34
)
 
$
0.84

Consolidated net income (loss) per common share, diluted
(0.27
)
 
(0.27
)
 
(0.34
)
 
0.76

Shares used in computing consolidated net income (loss) per common share, basic
103,516

 
103,608

 
103,616

 
103,623

Shares used in computing consolidated net income (loss) per common share, diluted
103,516

 
103,608

 
103,616

 
115,764

2014
 
 
 
 
 
 
 
Revenues
$
277

 
$
676

 
$
419

 
$
21,482

Loss from operations
$
(30,472
)
 
$
(26,111
)
 
$
(40,336
)
 
$
(3,447
)
Consolidated net loss
$
(30,835
)
 
$
(26,028
)
 
$
(40,498
)
 
$
(2,933
)
Consolidated net loss per common share, basic and diluted
$
(0.42
)
 
$
(0.35
)
 
$
(0.55
)
 
$
(0.03
)
Shares used in computing consolidated net loss per common share, basic and diluted
73,422

 
73,518

 
73,542

 
84,813


For all periods presented other than the quarter ended December 31, 2015, the weighted average number of shares outstanding are the same for both basic and diluted consolidated net loss per common share. For these periods, shares associated with convertible debt, stock options and restricted stock units are not included in the weighted average number of shares of common stock outstanding because they are antidilutive. A reconciliation of the numerator and denominator of basic and diluted earnings per share for the quarter ended December 31, 2015 is presented below (in thousands, expect per share amounts):

Consolidated net income, basic
$
86,750

Interest on convertible debt
1,277

Consolidated net income, diluted
$
88,027

 
 
Shares used in computing consolidated net income per common share, basic
103,623

Share-based compensation awards
1,776

Convertible debt
10,365

Shares used in computing consolidated net income per common share, diluted
115,764

 
 
Consolidated net income per common share, basic
$
0.84

Consolidated net income per common share, diluted
$
0.76


v3.3.1.900
Summary of Significant Accounting Policies (Policies)
12 Months Ended
Dec. 31, 2015
Basis of Presentation [Abstract]  
Consolidation, Policy
Basis of Presentation: The accompanying consolidated financial statements include the accounts of Lexicon and its wholly-owned subsidiaries. Intercompany transactions and balances are eliminated in consolidation.
Use of Estimates, Policy
Use of Estimates: The preparation of financial statements in conformity with U. S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates.
Cash and Cash Equivalents, Policy
Cash, Cash Equivalents and Short-Term Investments: Lexicon considers all highly-liquid investments with original maturities of three months or less to be cash equivalents.  As of December 31, 2015, short-term investments consist of U.S. treasury bills and corporate debt securities. As of December 31, 2014, short-term investments consist of U.S. treasury bills and certificates of deposit. The Company’s short-term investments are classified as available-for-sale securities and are carried at fair value, based on quoted market prices of the securities.  The Company views its available-for-sale securities as available for use in current operations regardless of the stated maturity date of the security.  Unrealized gains and losses on such securities are reported as a separate component of stockholders’ equity.  Net realized gains and losses, interest and dividends are included in interest income.  The cost of securities sold is based on the specific identification method.
Cash and Cash Equivalents, Restricted Cash and Cash Equivalents, Policy
Restricted Cash and Investments:  Lexicon was required to maintain restricted cash or investments to collateralize standby letters of credit for the lease on its office and laboratory facilities in Hopewell, New Jersey that terminated in June 2015.
Trade and Other Accounts Receivable, Policy
Accounts Receivable:  Lexicon records trade accounts receivable in the normal course of business related to the sale of products or services.   The allowance for doubtful accounts takes into consideration such factors as historical write-offs, the economic climate and other factors that could affect collectibility.  Write-offs are evaluated on a case by case basis.
Concentration Risk Disclosure
Concentration of Credit Risk: Lexicon’s cash equivalents, investments and accounts receivable represent potential concentrations of credit risk. The Company attempts to minimize potential concentrations of risk in cash equivalents and investments by placing investments in high-quality financial instruments. The Company’s accounts receivable are unsecured and are concentrated in pharmaceutical and biotechnology companies located in the United States.  The Company has not experienced any significant credit losses to date.
Segment Reporting Disclosure
Segment Information and Significant Customers: Lexicon operates in one business segment, which primarily focuses on the discovery of the functions and pharmaceutical utility of genes and the use of those gene function discoveries in the discovery and development of pharmaceutical products for the treatment of human disease. Substantially all of the Company’s revenues have been derived from drug discovery alliances, target validation collaborations for the development and, in some cases, analysis of the physiological effects of genes altered in knockout mice, technology licenses, subscriptions to its databases, government grants and contracts and compound library sales.
Property, Plant and Equipment, Policy
Property and Equipment: Property and equipment that is held and used is carried at cost and depreciated using the straight-line method over the estimated useful life of the assets which ranges from three to 40 years.  Maintenance, repairs and minor replacements are charged to expense as incurred.  Leasehold improvements are amortized over the shorter of the estimated useful life or the remaining lease term.  Significant renewals and betterments are capitalized.
Impairment or Disposal of Long-Lived Assets, Policy
Impairment of Long-Lived Assets:  Long-lived assets and certain identifiable intangible assets to be held and used are reviewed for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by comparison of the carrying amount of an asset to future net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount that the carrying amount of the assets exceeds the fair value of the assets. Assets to be disposed of are reported at the lower of the carrying amount or fair value less costs to sell.
Goodwill and Intangible Assets, Policy
Indefinite lived intangible assets are also tested annually for impairment and whenever indicators of impairment are present. When performing the impairment assessment, the Company first assesses qualitative factors to determine whether it is necessary to recalculate the fair value of its intangible assets. If management believes, as a result of the qualitative assessment, that it is more likely than not that the fair value of the intangible assets is less than its carrying amount, the Company calculates the asset’s fair value. If the carrying value of the asset exceeds its fair value, then the intangible asset is written down to its fair value.

Goodwill Impairment:  Goodwill is not amortized, but is tested at least annually for impairment at the reporting unit level.  The Company has determined that the reporting unit is the single operating segment disclosed in its current financial statements. Impairment is the condition that exists when the carrying amount of goodwill exceeds its implied fair value.  The first step in the impairment process is to determine the fair value of the reporting unit and then compare it to the carrying value, including goodwill.  If the fair value exceeds the carrying value, no further action is required and no impairment loss is recognized.  Additional impairment assessments may be performed on an interim basis if the Company encounters events or changes in circumstances that would indicate that, more likely than not, the carrying value of goodwill has been impaired.
Revenue Recognition, Policy
Revenue Recognition: Revenues are recognized when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectibility is reasonably assured.  

Collaborative agreements revenues include both license revenue and contract research revenue. Activities under collaborative agreements are evaluated to determine if they represent a multiple element revenue agreement. The Company identifies the deliverables included within the agreement and evaluates which deliverables represent separate units of accounting. The Company accounts for those components as separate units of accounting if the following two criteria are met:

The delivered item or items have value to the customer on a stand-alone basis.
If there is a general right of return relative to the delivered items, delivery or performance of the undelivered items is considered probable and within the Company’s control.

Factors considered in this determination include, among other things, whether any other vendors sell the items separately and if the licensee could use the delivered item for its intended purpose without the receipt of the remaining deliverables. If multiple deliverables included in an arrangement are separable into different units of accounting, the Company allocates the arrangement consideration to those units of accounting. The amount of allocable arrangement consideration is limited to amounts that are fixed or determinable. Arrangement consideration is allocated at the inception of the arrangement to the identified units of accounting based on their relative estimated selling price. Revenue is recognized for each unit of accounting when the appropriate revenue recognition criteria are met.

Future milestone payments that are contingent upon the achievement of a substantive milestone are recognized in their entirety in the period in which the milestone is achieved. A milestone is substantive if:

It can only be achieved based in whole or in part on either the Company’s performance or on the occurrence of a specific outcome resulting from the Company’s performance;
There is substantive uncertainty at the date an arrangement is entered into that the event will be achieved; and
It would result in additional payments being due to the Company.

Subscription and license fees are recognized as revenue upon the grant of the technology license when performance is complete and there is no continuing involvement. Royalty revenues are recognized as earned in accordance with the contract terms at the time the royalty amount is fixed and determinable based on information received from the sublicensees and at the time collectibility is reasonably assured.
Research and Development Expense, Policy
Research and Development Expenses: Research and development expenses consist of costs incurred for company-sponsored as well as collaborative research and development activities. These costs include direct and research-related overhead expenses and are expensed as incurred.  Technology license fees for technologies that are utilized in research and development and have no alternative future use are expensed when incurred. Substantial portions of the Company’s preclinical and clinical trials are performed by third-party laboratories, medical centers, contract research organizations and other vendors. For preclinical studies, the Company accrues expenses based upon estimated percentage of work completed and the contract milestones remaining. For clinical studies, expenses are accrued based upon the number of patients enrolled and the duration of the study. The Company monitors patient enrollment, the progress of clinical studies and related activities to the extent possible through internal reviews of data reported to the Company by the vendors and clinical site visits. The Company’s estimates depend on the timeliness and accuracy of the data provided by the vendors regarding the status of each program and total program spending. The Company periodically evaluates the estimates to determine if adjustments are necessary or appropriate based on information it receives.
Share-based Compensation, Option and Incentive Plans Policy
Stock-Based Compensation:  The Company recognizes compensation expense in its statements of comprehensive loss for share-based payments, including stock options and restricted stock units issued to employees, based on their fair values on the date of the grant, with the compensation expense recognized over the period in which an employee is required to provide service in exchange for the stock award.  Stock-based compensation expense for awards without performance conditions is recognized on a straight-line basis. Stock-based compensation expense for awards with performance conditions is recognized over the period from the date the performance condition is determined to be probable of occurring through the time the applicable condition is met.  As of December 31, 2015, stock-based compensation cost for all outstanding unvested options and restricted stock units was $10.5 million, which is expected to be recognized over a weighted-average period of 1.3 years.
 
The fair value of stock options is estimated at the date of grant using the Black-Scholes method.  The Black-Scholes option-pricing model requires the input of subjective assumptions.  Because the Company’s employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in management’s opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its employee stock options.  For purposes of determining the fair value of stock options, the Company segregates its options into two homogeneous groups, based on exercise and post-vesting employment termination behaviors, resulting in a change in the assumptions used for expected option lives and forfeitures.  Expected volatility is based on the historical volatility in the Company’s stock price.
Earnings Per Share, Policy
Net Loss per Common Share: Net loss per common share is computed using the weighted average number of shares of common stock outstanding. Shares associated with convertible debt, stock options and restricted stock units are not included because they are antidilutive.

v3.3.1.900
Summary of Significant Accounting Policies (Tables)
12 Months Ended
Dec. 31, 2015
Share-based Compensation [Abstract]  
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions
 
Expected Volatility
 
Risk-free Interest Rate
 
Expected Term
 
Dividend
Rate
December 31, 2015:
 
 
 
 
 
 
 
Employees
64%
 
1.2%
 
4
 
0
%
Officers and non-employee directors
81%
 
1.8%
 
8
 
0
%
December 31, 2014:

 

 

 

Employees
66%
 
1.2%
 
4
 
0
%
Officers and non-employee directors
80%
 
2.3%
 
8
 
0
%
December 31, 2013:

 

 

 

Employees
85%
 
0.9%
 
5
 
0
%
Officers and non-employee directors
81%
 
1.6%
 
8
 
0
%

v3.3.1.900
Cash and Cash Equivalents and Investments (Tables)
12 Months Ended
Dec. 31, 2015
Cash and Cash Equivalents and Investments [Abstract]  
Schedule of Cash, Cash Equivalents and Short-term Investments
 
As of December 31, 2015
 
Amortized Cost
 
Gross Unrealized Gains
 
Gross Unrealized Losses
 
Estimated Fair Value
 
 
 
(in thousands)
 
 
Cash and cash equivalents
$
202,989

 
$

 
$

 
$
202,989

Securities maturing within one year:
 
 
 
 
 
 
 
U.S. treasury securities
313,105

 
2

 
(219
)
 
312,888

Corporate debt securities
5,477

 

 
(2
)
 
5,475

Total short-term investments
$
318,582

 
$
2

 
$
(221
)
 
$
318,363

Total cash and cash equivalents and investments
$
521,571

 
$
2

 
$
(221
)
 
$
521,352

 
 
As of December 31, 2014
 
Amortized Cost
 
Gross Unrealized Gains
 
Gross Unrealized Losses
 
Estimated Fair Value
 
 
 
(in thousands)
 
 
Cash and cash equivalents
$
137,266

 
$

 
$

 
$
137,266

Securities maturing within one year:
 
 
 
 
 
 
 
Certificates of deposit
552

 

 

 
552

U.S. treasury securities
201,584

 
3

 
(66
)
 
201,521

Total short-term investments
$
202,136

 
$
3

 
$
(66
)
 
$
202,073

Total cash and cash equivalents and investments
$
339,402

 
$
3

 
$
(66
)
 
$
339,339


v3.3.1.900
Fair Value Measurements (Tables)
12 Months Ended
Dec. 31, 2015
Fair Value Measurements [Abstract]  
Fair Value, by Balance Sheet Grouping
 
Assets and Liabilities at Fair Value
 
As of December 31, 2015
 
Level 1
 
Level 2
 
Level 3
 
Total
 
(in thousands)
Assets
 
 
 
 
 
 
 
Cash and cash equivalents
$
200,526

 
$
2,463

 
$

 
$
202,989

Short-term investments
312,888

 
5,475

 

 
318,363

Total cash and cash equivalents and investments
$
513,414

 
$
7,938

 
$

 
$
521,352

Liabilities
 
 
 
 
 
 
 
Accrued liabilities
$

 
$

 
$
12,453

 
$
12,453

Other long-term liabilities

 

 
10,362

 
10,362

Total liabilities
$

 
$

 
$
22,815

 
$
22,815



 
Assets and Liabilities at Fair Value
 
As of December 31, 2014
 
Level 1
 
Level 2
 
Level 3
 
Total
 
(in thousands)
Assets
 
 
 
 
 
 
 
Cash and cash equivalents
$
137,266

 
$

 
$

 
$
137,266

Short-term investments
201,521

 
552

 

 
202,073

Total cash and cash equivalents and investments
$
338,787

 
$
552

 
$

 
$
339,339

Liabilities
 
 
 
 
 
 
 
Other long-term liabilities
$

 
$

 
$
17,638

 
$
17,638

Total liabilities
$

 
$

 
$
17,638

 
$
17,638

Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation
 
Other Long-term Liabilities
 
(in thousands)
Balance at December 31, 2012
$
29,920

Change in valuation of purchase consideration payable to former Symphony Icon stockholders
(2,210
)
Balance at December 31, 2013
27,710

Change in valuation of purchase consideration payable to former Symphony Icon stockholders
1,428

Payment of base payment obligation with common stock and cash
(11,500
)
Balance at December 31, 2014
17,638

Change in valuation of purchase consideration payable to former Symphony Icon stockholders
5,927

Payment of contingent payment obligation with cash
(750
)
Balance at December 31, 2015
$
22,815


v3.3.1.900
Property and Equipment (Tables)
12 Months Ended
Dec. 31, 2015
Property and Equipment [Abstract]  
Property, Plant and Equipment
 
Estimated Useful Lives
 
As of December 31,
 
In Years
 
2015
 
2014
 
 
 
 
 
(in thousands)
Computers and software
3-5
 
$
8,457

 
$
9,468

Furniture and fixtures
5-7
 
6,269

 
7,032

Laboratory equipment
3-7
 
3,908

 
12,737

Leasehold improvements
7-10
 
240

 
8,117

Buildings
15-40
 
59,117

 

Land
 

 
 
2,664

 

Total property and equipment
 
 
 
 
80,655

 
37,354

Less: Accumulated depreciation and amortization
 
 
 
 
(59,428
)
 
(36,274
)
Net property and equipment
 
 
 
 
$
21,227

 
$
1,080


v3.3.1.900
Income Taxes (Tables)
12 Months Ended
Dec. 31, 2015
Income Taxes [Abstract]  
Schedule of Deferred Tax Assets and Liabilities
 
As of December 31,
 
2015
 
2014
 
(in thousands)
Deferred tax assets:
 
 
 
Net operating loss carryforwards
$
263,138

 
$
255,518

Research and development tax credits
43,728

 
40,173

Capitalized research and development
85,385

 
95,946

Stock-based compensation
8,160

 
7,648

Deferred revenue
4,363

 
4,457

Other
8,831

 
8,681

Total deferred tax assets
413,605

 
412,423

Deferred tax liabilities:
 
 
 
Deferred tax liability related to acquisition of Symphony Icon
(18,675
)

(18,675
)
Total deferred tax liabilities
(18,675
)
 
(18,675
)
Less: valuation allowance
(413,605
)
 
(412,423
)
Net deferred tax liabilities
$
(18,675
)
 
$
(18,675
)

v3.3.1.900
Debt Obligations (Tables)
12 Months Ended
Dec. 31, 2015
Debt Instrument  
Schedule of Maturities of Long-term Debt
 
For the Year Ending
December 31
 
(in thousands)
2016
$
2,015

2017
16,293

2018

2019

2020

Thereafter
87,500

Total debt
105,808

Less current portion
(2,015
)
Total long-term debt
$
103,793




v3.3.1.900
Commitments and Contingencies (Tables)
12 Months Ended
Dec. 31, 2015
Commitments and Contingencies [Abstract]  
Schedule of Future Minimum Rental Payments for Operating Leases
 
For the Year Ending
December 31
 
(in thousands)
2016
$
512

2017
582

2018
595

2019
607

2020
620

Thereafter
1,277

Total
$
4,193


v3.3.1.900
Equity Incentive Awards (Tables)
12 Months Ended
Dec. 31, 2015
Equity Incentive Awards [Abstract]  
Schedule of Share-based Compensation, Stock Options, Activity
 
 
2015
 
2014
 
2013
(in thousands, except exercise price data)
 
Options
 
Weighted Average Exercise Price
 
Options
 
Weighted Average Exercise Price
 
Options
 
Weighted Average Exercise Price
Outstanding at beginning of year
 
3,371

 
$
14.98

 
3,329

 
$
16.94

 
3,075

 
$
17.57

Granted
 
1,207

 
6.83

 
643

 
11.76

 
499

 
14.91

Exercised
 
(19
)
 
11.14

 
(32
)
 
10.22

 
(82
)
 
12.25

Expired
 
(187
)
 
27.29

 
(476
)
 
24.78

 
(136
)
 
27.86

Forfeited
 
(155
)
 
8.51

 
(93
)
 
13.79

 
(27
)
 
13.58

Outstanding at end of year
 
4,217

 
12.35

 
3,371

 
14.98

 
3,329

 
16.94

Exercisable at end of year
 
2,686

 
$
14.53

 
2,417

 
$
15.89

 
2,483

 
$
17.92

Schedule of Nonvested Restricted Stock Units Activity
 
 
Shares
 
Weighted Average Grant Date Fair Value
 
 
(in thousands)
 
 
Outstanding at December 31, 2014
 
447

 
$
12.88

Granted
 
452

 
6.23

Vested
 
(166
)
 
12.91

Forfeited
 
(96
)
 
8.98

Nonvested at December 31, 2015
 
637

 
$
8.74


v3.3.1.900
Selected Quarterly Financial Data (Tables)
12 Months Ended
Dec. 31, 2015
Selected Quarterly Financial Data [Abstract]  
Selected Quarterly Financial Data
Selected Quarterly Financial Data (Unaudited)
 
The table below sets forth certain unaudited statements of comprehensive loss data, and net loss per common share data, for each quarter of 2015 and 2014:
 
(in thousands, except per share data)
 
Quarter Ended
 
March 31
 
June 30
 
September 30
 
December 31
 
 
 
(Unaudited)
 
 
2015
 

 
 

 
 

 
 

Revenues
$
1,792

 
$
376

 
$
566

 
$
127,280

Income (loss) from operations
$
(26,527
)
 
$
(26,688
)
 
$
(33,677
)
 
$
88,360

Consolidated net income (loss)
$
(28,076
)
 
$
(26,074
)
 
$
(35,282
)
 
$
86,750

Consolidated net income (loss) per common share, basic
$
(0.27
)
 
$
(0.27
)
 
$
(0.34
)
 
$
0.84

Consolidated net income (loss) per common share, diluted
(0.27
)
 
(0.27
)
 
(0.34
)
 
0.76

Shares used in computing consolidated net income (loss) per common share, basic
103,516

 
103,608

 
103,616

 
103,623

Shares used in computing consolidated net income (loss) per common share, diluted
103,516

 
103,608

 
103,616

 
115,764

2014
 
 
 
 
 
 
 
Revenues
$
277

 
$
676

 
$
419

 
$
21,482

Loss from operations
$
(30,472
)
 
$
(26,111
)
 
$
(40,336
)
 
$
(3,447
)
Consolidated net loss
$
(30,835
)
 
$
(26,028
)
 
$
(40,498
)
 
$
(2,933
)
Consolidated net loss per common share, basic and diluted
$
(0.42
)
 
$
(0.35
)
 
$
(0.55
)
 
$
(0.03
)
Shares used in computing consolidated net loss per common share, basic and diluted
73,422

 
73,518

 
73,542

 
84,813


For all periods presented other than the quarter ended December 31, 2015, the weighted average number of shares outstanding are the same for both basic and diluted consolidated net loss per common share. For these periods, shares associated with convertible debt, stock options and restricted stock units are not included in the weighted average number of shares of common stock outstanding because they are antidilutive. A reconciliation of the numerator and denominator of basic and diluted earnings per share for the quarter ended December 31, 2015 is presented below (in thousands, expect per share amounts):

Consolidated net income, basic
$
86,750

Interest on convertible debt
1,277

Consolidated net income, diluted
$
88,027

 
 
Shares used in computing consolidated net income per common share, basic
103,623

Share-based compensation awards
1,776

Convertible debt
10,365

Shares used in computing consolidated net income per common share, diluted
115,764

 
 
Consolidated net income per common share, basic
$
0.84

Consolidated net income per common share, diluted
$
0.76

Schedule of Earnings Per Share, Basic and Diluted [Table Text Block]
Consolidated net income, basic
$
86,750

Interest on convertible debt
1,277

Consolidated net income, diluted
$
88,027

 
 
Shares used in computing consolidated net income per common share, basic
103,623

Share-based compensation awards
1,776

Convertible debt
10,365

Shares used in computing consolidated net income per common share, diluted
115,764

 
 
Consolidated net income per common share, basic
$
0.84

Consolidated net income per common share, diluted
$
0.76


v3.3.1.900
Summary of Significant Accounting Policies Restricted Cash and Investments (Details) - USD ($)
$ in Thousands
Dec. 31, 2015
Dec. 31, 2014
Restricted Cash and Cash Equivalents Items    
Restricted investments $ 0 $ 430

v3.3.1.900
Summary of Significant Accounting Policies Concentration of Credit Risk (Details)
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Concentration Risk      
Disclosure On Geographic Areas Revenue From External Customers Attributed to France 99.00% 94.00%  
Disclosure on Geographic Areas, Revenue from External Customers Attributed to Entity's Country of Domicile, Percent 1.00% 6.00% 100.00%

v3.3.1.900
Summary of Significant Accounting Policies Segment Information and Signficant Customers (Details)
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Revenue, Major Customer      
Entity Wide Revenue Sanofi Percentage 98.00%    
Entity Wide Revenue Ipsen Percentage   94.00%  
Entity-Wide Revenue, McNair Medical Institute, Percentage     57.00%
Entity-Wide Revenue, Taconic Farms, Percentage     33.00%

v3.3.1.900
Summary of Significant Accounting Policies Impairment of Long-Lived Assets (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Accounting Policies [Abstract]      
Asset Impairment Charges $ 3,597 $ 13,102 $ 0

v3.3.1.900
Summary of Significant Accounting Policies Stock-Based Compensation (Details 1) - Stock Option
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Share-based Compensation Arrangement by Share-based Payment Award      
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected VolatilityRate, Employees 64.00% 66.00% 85.00%
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Employee 1.20% 1.20% 0.90%
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term, Employees 4 years 4 years 5 years
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate, Employees 0.00% 0.00% 0.00%
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate, Officers and Non-employee Directors 81.00% 80.00% 81.00%
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate, Officers and Non-employee Directors 1.80% 2.30% 1.60%
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term, Officers and Non-employee Directors 8 years 8 years 8 years
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate, Officers and Non-employee Directors 0.00% 0.00% 0.00%

v3.3.1.900
Summary of Significant Accounting Policies Stock-based Compensation (Details 2)
$ in Millions
12 Months Ended
Dec. 31, 2015
USD ($)
Employee Service Share-based Compensation, Allocation of Recognized Period Costs  
Employee Service Share-based Compensation, Nonvested Awards, Total Compensation Cost Not yet Recognized $ 10.5
Employee Service Share-based Compensation, Outstanding, Weighted Average Remaining Vesting Period 1 year 4 months

v3.3.1.900
Cash and Cash Equivalents and Investments (Details) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Cash and Cash Equivalents      
Realized Investment Gains (Losses) $ 0 $ 0 $ 0
Cash      
Cash and Cash Equivalents      
Available-for-sale Securities, Amortized Cost Basis 202,989 137,266  
Available-for-sale Securities, Gross Unrealized Gain Accumulated in Investments 0 0  
Available-for-sale Securities, Gross Unrealized Losses 0 0  
Available-for-sale Securities, Current 202,989 137,266  
Certificates of Deposit      
Cash and Cash Equivalents      
Available-for-sale Securities, Amortized Cost Basis   552  
Available-for-sale Securities, Gross Unrealized Gain Accumulated in Investments   0  
Available-for-sale Securities, Gross Unrealized Losses   0  
Available-for-sale Securities, Current   552  
US Treasury Securities      
Cash and Cash Equivalents      
Available-for-sale Securities, Amortized Cost Basis 313,105 201,584  
Available-for-sale Securities, Gross Unrealized Gain Accumulated in Investments 2 3  
Available-for-sale Securities, Gross Unrealized Losses (219) (66)  
Available-for-sale Securities, Current 312,888 201,521  
Corporate Debt Securities [Member]      
Cash and Cash Equivalents      
Available-for-sale Securities, Amortized Cost Basis 5,477    
Available-for-sale Securities, Gross Unrealized Gain Accumulated in Investments 0    
Available-for-sale Securities, Gross Unrealized Losses (2)    
Available-for-sale Securities, Current 5,475    
Short-term Investments      
Cash and Cash Equivalents      
Available-for-sale Securities, Amortized Cost Basis 318,582 202,136  
Available-for-sale Securities, Gross Unrealized Gain Accumulated in Investments 2 3  
Available-for-sale Securities, Gross Unrealized Losses (221) (66)  
Available-for-sale Securities, Current 318,363 202,073  
Cash and Cash Equivalents and Investments      
Cash and Cash Equivalents      
Available-for-sale Securities, Amortized Cost Basis 521,571 339,402  
Available-for-sale Securities, Gross Unrealized Gain Accumulated in Investments 2 3  
Available-for-sale Securities, Gross Unrealized Losses (221) (66)  
Available-for-sale Securities, Current $ 521,352 $ 339,339  

v3.3.1.900
Fair Value Measurements (Details 1) - USD ($)
$ in Thousands
Dec. 31, 2015
Dec. 31, 2014
Fair Value, Level 1    
Fair Value, Balance Sheet Grouping, Financial Statement Captions    
Cash and Cash Equivalents, Fair Value Disclosure $ 200,526 $ 137,266
Available-for-sale Securities, Fair Value Disclosure 312,888 201,521
Investments, Fair Value Disclosure 513,414 338,787
Accrued Liabilities, Fair Value Disclosure 0  
Other Liabilities, Fair Value Disclosure 0 0
Liabilities, Fair Value Disclosure 0 0
Fair Value, Level 2    
Fair Value, Balance Sheet Grouping, Financial Statement Captions    
Cash and Cash Equivalents, Fair Value Disclosure 2,463 0
Available-for-sale Securities, Fair Value Disclosure 5,475 552
Investments, Fair Value Disclosure 7,938 552
Accrued Liabilities, Fair Value Disclosure 0  
Other Liabilities, Fair Value Disclosure 0 0
Liabilities, Fair Value Disclosure 0 0
Fair Value, Level 3    
Fair Value, Balance Sheet Grouping, Financial Statement Captions    
Cash and Cash Equivalents, Fair Value Disclosure 0 0
Available-for-sale Securities, Fair Value Disclosure 0 0
Investments, Fair Value Disclosure 0 0
Accrued Liabilities, Fair Value Disclosure 12,453  
Other Liabilities, Fair Value Disclosure 10,362 17,638
Liabilities, Fair Value Disclosure 22,815 17,638
Fair Value, Total    
Fair Value, Balance Sheet Grouping, Financial Statement Captions    
Cash and Cash Equivalents, Fair Value Disclosure 202,989 137,266
Available-for-sale Securities, Fair Value Disclosure 318,363 202,073
Investments, Fair Value Disclosure 521,352 339,339
Accrued Liabilities, Fair Value Disclosure 12,453  
Other Liabilities, Fair Value Disclosure 10,362 17,638
Liabilities, Fair Value Disclosure $ 22,815 $ 17,638

v3.3.1.900
Fair Value Measurements (Details 2) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Dec. 31, 2012
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation        
Increase (decrease) in fair value of Symphony Icon, Inc. purchase liability $ 5,927 $ 1,428 $ (2,210)  
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Gain (Loss) Included in Earnings 5,927 1,428 (2,210)  
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Liability, Settlements (750) (11,500)    
Fair Value, Measurement with Unobservable Inputs Reconciliations, Recurring Basis, Liability Value $ 22,815 $ 17,638 $ 27,710 $ 29,920

v3.3.1.900
Buildings and Land for Sale (Details) - USD ($)
$ in Thousands
1 Months Ended 12 Months Ended
Jan. 31, 2016
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Property, Plant and Equipment Impairment or Disposal [Abstract]        
Fair Value of Assets to be Sold   $ 20,300 $ 23,800  
Asset Impairment Charges   $ 3,597 $ 13,102 $ 0
Real Estate Selling Price $ 21,200      

v3.3.1.900
Property and Equipment (Details 1) - USD ($)
$ in Thousands
Dec. 31, 2015
Dec. 31, 2014
Property, Plant and Equipment    
Property, Plant and Equipment, Gross $ 80,655 $ 37,354
Accumulated Depreciation, Depletion and Amortization, Property, Plant, and Equipment (59,428) (36,274)
Property, Plant and Equipment, Net 21,227 1,080
Computers and Software    
Property, Plant and Equipment    
Property, Plant and Equipment, Gross 8,457 9,468
Furniture and Fixtures    
Property, Plant and Equipment    
Property, Plant and Equipment, Gross 6,269 7,032
Laboratory Equipment    
Property, Plant and Equipment    
Property, Plant and Equipment, Gross 3,908 12,737
Leasehold Improvements    
Property, Plant and Equipment    
Property, Plant and Equipment, Gross 240 8,117
Buildings    
Property, Plant and Equipment    
Property, Plant and Equipment, Gross 59,117 0
Land    
Property, Plant and Equipment    
Property, Plant and Equipment, Gross $ 2,664 $ 0

v3.3.1.900
Property and Equipment (Details 2)
$ in Millions
Dec. 31, 2014
USD ($)
Long Lived Assets Held-for-sale [Line Items]  
Buildings Reclassified To Held For Sale $ 59.1
Land Reclassified To Held For Sale 2.7
Accumulated Depreciation Reclassified To Held For Sale $ 38.0

v3.3.1.900
Income Taxes (Details 1) - USD ($)
$ in Thousands
Dec. 31, 2015
Dec. 31, 2014
Deferred Tax Assets and Liabilities    
Deferred Tax Assets, Operating Loss Carryforwards $ 263,138 $ 255,518
Deferred Tax Assets, Tax Credit Carryforwards, Research 43,728 40,173
Deferred Tax Assets, In Process Research and Development 85,385 95,946
Deferred Tax Assets, Tax Deferred Expense, Compensation and Benefits, Share-based Compensation Cost 8,160 7,648
Deferred Tax Assets, Deferred Income 4,363 4,457
Deferred Tax Assets, Other 8,831 8,681
Deferred Tax Assets, Gross 413,605 412,423
Deferred Tax Liability Related to Acquisition of Symphony Icon (18,675) (18,675)
Deferred Tax Liabilities, Gross (18,675) (18,675)
Deferred Tax Assets, Valuation Allowance (413,605) (412,423)
Deferred Tax Liabilities, Net $ (18,675) $ (18,675)

v3.3.1.900
Income Taxes (Details 2) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Other Tax Information      
Valuation Allowance, Deferred Tax Asset, Change in Amount $ 1,200    
Operating Loss Carryforwards, Federal 738,000    
Operating Loss Carryforwards, State 455,100    
Income Tax Expense (Benefit) $ 0 $ (70) $ 0

v3.3.1.900
Goodwill (Details) - USD ($)
$ in Millions
Jul. 30, 2010
Jul. 12, 2001
Goodwill    
Coelacanth Goodwill   $ 25.8
Coelacanth Purchase Price   $ 36.0
Symphony Icon Goodwill $ 18.7  

v3.3.1.900
Debt Obligations (Details 1) - USD ($)
$ in Thousands
Dec. 31, 2015
Dec. 31, 2014
Debt Instrument    
Long-term Debt, Maturities, Repayments of Principal in Next Twelve Months $ 2,015  
Long-term Debt, Maturities, Repayments of Principal in Year Two 16,293  
Long-term Debt, Maturities, Repayments of Principal in Year Three 0  
Long-term Debt, Maturities, Repayments of Principal in Year Four 0  
Long-term Debt, Maturities, Repayments of Principal in Year Five 0  
Long-term Debt, Maturities, Repayments of Principal after Year Five 87,500  
Long-term Debt, Gross 105,808  
Long-term Debt, Current Maturities 2,015 $ 20,167
Long-term Debt, Excluding Current Maturities $ 103,793 $ 87,500

v3.3.1.900
Debt Obligations (Details 2)
$ / shares in Units, $ in Millions
1 Months Ended
Nov. 30, 2014
USD ($)
Apr. 30, 2004
USD ($)
Dec. 31, 2015
USD ($)
$ / shares
Debt Instrument      
Proceeds from Convertible Debt $ 87.5    
Convertible Debt Instrument Interest Rate Stated Percentage     5.25%
Debt Instrument, Convertible, Conversion Ratio 118.4553    
Debt Instrument, Convertible, Conversion Price | $ / shares     $ 8.442
Debt Issuance Cost $ 3.4    
Unamortized Debt Issuance Expense     $ 2.8
Debt Instrument, Fair Value Disclosure     $ 154.2
Woodlands Mortgage   $ 34.0  
Woodlands Cash Paid   $ 20.8  
Debt Instrument, Interest Rate, Stated Percentage     8.23%
Mortgage Loans on Real Estate, Carrying Amount of Mortgages     $ 18.3
Buildings Collateral     59.1
Land Collateral     $ 2.7

v3.3.1.900
Arrangements with Symphony Icon, Inc. (Details) - USD ($)
$ in Thousands
12 Months Ended
Apr. 24, 2015
Dec. 04, 2014
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Jul. 30, 2012
Jul. 30, 2010
Jun. 15, 2007
Loss Contingencies                
Holdings Contribution To Icon               $ 45,000
Lexicon Sold Shares To Holdings               1,092,946
Lexicon Received Cash From Holdings               $ 15,000
Lexicon Paid Holdings Cash             $ 10,000  
Symphony Fair Value Of Base And Contingent Payments             $ 45,600  
Symphony Base Payment Discount Rate             14.00%  
Symphony Contingent Payment Discount Rate             18.00%  
Symphony Base Payment In Shares           1,891,074    
Symphony Base Payment Obligation           $ 35,000    
Symphony Contingent Payment Maximum             $ 45,000  
Symphony Contingent Payment Percentage             50.00%  
Symphony Regulatory Approval Payment             $ 15,000  
Symphony Regulatory Approval Reduction Percentage             50.00%  
Symphony Regulatory Approval Percentage Limit             50.00%  
Symphony Payment In Stock Limitation             50.00%  
Symphony Contingent Payment In Cash $ 750 $ 5,800            
Symphony Contingent Payment in Shares   666,111            
Symphony Contingent Payment Total   $ 11,500            
Increase (decrease) in fair value of Symphony Icon, Inc. purchase liability     $ 5,927 $ 1,428 $ (2,210)      

v3.3.1.900
Commitments and Contingencies (Details 1) - USD ($)
$ in Thousands
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Operating Leased Assets      
Restricted Investments $ 0 $ 430  
Operating Leases, Rent Expense $ 100 $ 1,000 $ 900

v3.3.1.900
Commitments and Contingencies (Details 2)
$ in Thousands
Dec. 31, 2015
USD ($)
Operating Leased Assets  
Operating Leases, Future Minimum Payments Due, Next Twelve Months $ 512
Operating Leases, Future Minimum Payments, Due in Two Years 582
Operating Leases, Future Minimum Payments, Due in Three Years 595
Operating Leases, Future Minimum Payments, Due in Four Years 607
Operating Leases, Future Minimum Payments, Due in Five Years 620
Operating Leases, Future Minimum Payments, Due Thereafter 1,277
Operating Leases, Future Minimum Payments Due $ 4,193

v3.3.1.900
Other Capital Stock Agreements (Details) - USD ($)
$ / shares in Units, $ in Millions
1 Months Ended
Nov. 30, 2014
May. 20, 2015
Schedule of Capitalization, Equity    
Stock Issued During Period, Shares, New Issues 7,944,133  
Offering Price Per Share $ 7.035  
Net Proceeds From Stock Offering $ 201.9  
Payments of Underwriting Discounts and Commissions 3.4  
Payments of Stock Issuance Costs $ 0.6  
Stock Issued During Period to Invus, Shares 21,321,961  
Common Stock, Shares Authorized Before Reverse Stock Split   900,000,000
Common Stock, Shares Authorized After Reverse Stock Split   225,000,000

v3.3.1.900
Equity Incentive Awards (Details 1)
12 Months Ended
Dec. 31, 2015
USD ($)
shares
Share-based Compensation Arrangement by Share-based Payment Award  
Stock Option Exercise Price as Percent of Value of Common Stock 100.00%
Restricted Stock Purchase Price as Percent of Value of Common Stock 85.00%
Total Shares That May be Issued, Equity Incentive Plan 10,000,000
Limit On Shares That May Be Issued Other Than Stock Options or SARs, Equity Incentive Plan 3,571,428
Options Outstanding, Equity Incentive Plan 4,046,758
Restricted Stock Units Outstanding, Equity Incentive Plan 636,906
Stock Options Exercised, Equity Incentive Plan 858,875
Shares Issued Pursuant to Restricted Stock Units, Equity Incentive Plan 626,839
Shares Issued Pursuant to Stock Bonus Awards, Equity Incentive Plan 113,940
Directors Intial Option Grant 4,285
Directors Annual Option Grant 2,857
Directors Annual Restricted Stock Award Value | $ $ 20,000
Total Shares That May Be Issued, Non-Employee Directors Equity Incentive Plan 357,142
Options Outstanding, Non-Employee Directors Equity Incentive Plan 169,971
Stock Options Exercised, Non-Employee Directors Equity Incentive Plan 0
Shares Issued Pursuant to Restricted Stock Awards, Non-Employee Directors Equity Incentive Plan 60,992
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized 4,853,635
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant 3,842,861

v3.3.1.900
Equity Incentive Awards (Details 2) - USD ($)
$ / shares in Units, shares in Thousands
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Dec. 31, 2012
Share-based Compensation Arrangement by Share-based Payment Award        
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value $ 4.58 $ 8.61 $ 11.13  
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Total Intrinsic Value $ 35,000 $ 43,000 $ 325,000  
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Remaining Contractual Term 6 years 1 month      
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Remaining Contractual Term 4 years 6 months      
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Intrinsic Value $ 10,000,000      
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Intrinsic Value $ 2,400,000      
Employee Stock Option [Member]        
Share-based Compensation Arrangement by Share-based Payment Award        
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number 4,217 3,371 3,329 3,075
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price $ 12.35 $ 14.98 $ 16.94 $ 17.57
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross 1,207 643 499  
Share-based Compensation Arrangements by Share-based Payment Award, Options, Grants in Period, Weighted Average Exercise Price $ 6.83 $ 11.76 $ 14.91  
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period (19) (32) (82)  
Share-based Compensation Arrangements by Share-based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price $ 11.14 $ 10.22 $ 12.25  
Share-based Compensation Arrangement by Share-based Payment Award, Options, Expirations in Period (187) (476) (136)  
Share-based Compensation Arrangements by Share-based Payment Award, Options, Expirations in Period, Weighted Average Exercise Price $ 27.29 $ 24.78 $ 27.86  
Share-based Compensation Arrangement by Share-based Payment Award, Options, Forfeitures in Period (155) (93) (27)  
Share-based Compensation Arrangements by Share-based Payment Award, Options, Forfeitures in Period, Weighted Average Exercise Price $ 8.51 $ 13.79 $ 13.58  
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Number 2,686 2,417 2,483  
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercisable, Weighted Average Exercise Price $ 14.53 $ 15.89 $ 17.92  

v3.3.1.900
Equity Incentive Awards (Details 3) - $ / shares
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Share-based Compensation Arrangement by Share-based Payment Award      
Share-based Compensation Arrangement by Share-based Payment Award, Stock Bonus and Restricted Stock, Grants in Period 21,360 14,651 11,544
Share-based Compensation Arrangement by Share-based Payment Award, Stock Bonus and Restricted Stock, Grants in Period, Weighted Average Grant Date Fair Value $ 7.49 $ 10.92 $ 13.86
Share-based Compensation Arrangement by Share-based Payment Award, Stock Bonus and Restricted Stock to Consultants, Grants in Period   8,200  
Share-based Compensation Arrangement by Share-based Payment Award, Stock Bonus and Restricted Stock to Consultants, Grants in Period, Weighted Average Grant Date Fair Value   $ 11.20  

v3.3.1.900
Equity Incentive Awards (Details 4) - Restricted Stock Units (RSUs) - $ / shares
shares in Thousands
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Share-based Compensation Arrangement by Share-based Payment Award    
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number 637 447
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value $ 8.74 $ 12.88
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period 452  
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value $ 6.23  
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period (166)  
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Vested in Period, Weighted Average Grant Date Fair Value $ 12.91  
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Forfeited in Period (96)  
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Forfeited in Period, Weighted Average Fair Value $ 8.98  

v3.3.1.900
Benefit Plan (Details) - USD ($)
12 Months Ended
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Defined Benefit Plans and Other Postretirement Benefit Plans      
Defined Contribution Plan, Cost Recognized $ 332,000 $ 376,000 $ 511,000

v3.3.1.900
Collaboration and License Agreements (Details)
€ in Millions
1 Months Ended 12 Months Ended
Nov. 30, 2015
USD ($)
Oct. 31, 2014
USD ($)
Oct. 31, 2014
EUR (€)
Jul. 31, 2005
USD ($)
Dec. 31, 2015
USD ($)
Collaborative Arrangements and Non-collaborative Arrangement Transactions          
Sanofi Upfront Payment $ 300,000,000        
Sanofi Development and Regulatory Milestone Payments 430,000,000        
Sanofi Sales Milestone Payments 990,000,000        
Sanofi Development Costs Funded by Lexicon Maximum Amount 100,000,000        
Sanofi Revenue Allocated to License Deliverable 126,800,000        
Sanofi Revenue Allocated to Development Deliverable 113,800,000        
Sanofi Revenue Allocated to Funding Deliverable $ 59,400,000        
Sanofi Revenue Recognized         $ 126,800,000
Ipsen Total Upfront Payments   $ 24,500,000      
Ipsen Revenue Allocated to License Deliverable   21,200,000      
Ipsen Maximum Regulatory And Commercial Milestones   34,000,000      
Ipsen Revenue Allocated to Development Deliverable   1,700,000      
Ipsen Revenue Allocated to Committee Deliverable   $ 100,000      
Ipsen Revenue Recognized         21,400,000
Ipsen Maximum Sales Milestones | €     € 72    
TX Enterprise Fund Award       $ 35,000,000  
TX Enterprise Fund Award to Texas AM University System       $ 15,000,000  
TIGM Per Job Payment Amount         2,415
TIGM Maximum Exposure         14,200,000
TIGM Maximum Exposure Through Reporting Date         $ 6,400,000

v3.3.1.900
Selected Quarterly Financial Data (Details) - USD ($)
$ / shares in Units, shares in Thousands, $ in Thousands
3 Months Ended 12 Months Ended
Dec. 31, 2015
Sep. 30, 2015
Jun. 30, 2015
Mar. 31, 2015
Dec. 31, 2014
Sep. 30, 2014
Jun. 30, 2014
Mar. 31, 2014
Dec. 31, 2015
Dec. 31, 2014
Dec. 31, 2013
Condensed Financial Statements, Captions                      
Revenues $ 127,280 $ 566 $ 376 $ 1,792 $ 21,482 $ 419 $ 676 $ 277 $ 130,014 $ 22,854 $ 2,222
Income (Loss) From Operations 88,360 (33,677) (26,688) (26,527) (3,447) (40,336) (26,111) (30,472) $ 1,468 $ (100,366) $ (102,371)
Net Income (Loss) Available to Common Stockholders, Basic 86,750 $ (35,282) $ (26,074) $ (28,076) $ (2,933) $ (40,498) $ (26,028) $ (30,835)      
Net Income (Loss) Available to Common Stockholders, Diluted $ 88,027                    
Earnings Per Share, Basic $ 0.84 $ (0.34) $ (0.27) $ (0.27)              
Earnings Per Share, Diluted $ 0.76 $ (0.34) $ (0.27) $ (0.27)              
Weighted Average Number of Shares Outstanding, Basic 103,623 103,616 103,608 103,516              
Incremental Common Shares Attributable to Dilutive Effect of Conversion of Debt Securities 10,365                    
Weighted Average Number of Shares Outstanding, Diluted 115,764 103,616 103,608 103,516              
Consolidated Net Loss Per Common Share, Basic and Diluted         $ (0.03) $ (0.55) $ (0.35) $ (0.42) $ (0.05) $ (1.31) $ (1.42)
Shares Used In Computing Consolidated Net Loss Per Common Share Basic And Diluted         84,813 73,542 73,518 73,422 103,591 76,347 73,302
Interest on Convertible Debt, Net of Tax $ 1,277                    
Incremental Common Shares Attributable to Dilutive Effect of Share-based Payment Arrangements 1,776                    

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