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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 10-Q

(MARK ONE)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2016

o 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 000-50797

Momenta Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Its Charter)

Delaware		04-3561634
(State or Other Jurisdiction of		(I.R.S. Employer Identification No.)
Incorporation or Organization)

675 West Kendall Street, Cambridge, MA		02142
(Address of Principal Executive Offices)		(Zip Code)

(617) 491-9700

(Registrant’s Telephone Number, Including Area Code)

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 x 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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No o

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 Exchange Act. (Check one):

Large accelerated filer x		Accelerated filer o

Non-accelerated filer o		Smaller reporting company o
(Do not check if a smaller reporting company)

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

As of April 12, 2016, there were 69,496,190 shares of the registrant’s common stock, par value $0.0001 per share, outstanding.

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MOMENTA PHARMACEUTICALS, INC.

		Page

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS		3

PART I. FINANCIAL INFORMATION		4

Item 1.	Financial Statements (unaudited)	4

	Condensed Consolidated Balance Sheets as of March 31, 2016 and December 31, 2015	4

	Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three Months Ended March 31, 2016 and 2015	5

	Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2016 and 2015	6

	Notes to Unaudited, Condensed Consolidated Financial Statements	7

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	23

Item 3.	Quantitative and Qualitative Disclosures about Market Risk	30

Item 4.	Controls and Procedures	31

PART II. OTHER INFORMATION		32

Item 1.	Legal Proceedings	32

Item 1A.	Risk Factors	34

Item 6.	Exhibits	55

SIGNATURES		56

Our logo, trademarks and service marks are the property of Momenta Pharmaceuticals, Inc. Other trademarks or service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective holders.

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CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Statements contained in this Quarterly Report on Form 10-Q that are about future events or future results, or are otherwise not statements of historical fact, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based on current expectations, estimates, forecasts, projections, intentions, goals, strategies, plans, prospects and the beliefs and assumptions of our management. In some cases, these statements can be identified by words such as “anticipate,” “believe,” “continue,” “could,” “contemplate,” “target,” “likely,” “goal,” “objective,” “plan,” “potential,” “predict,” “might,” “estimate,” “expect,” “intend,” “may,” “seek”, “should,” “will,” “would,” “can,” “pursue” and other similar words or expressions, or the negative of these words or similar words or expressions. These statements include, but are not limited to, statements regarding our expectations regarding the development and utility of our products; product candidates and novel therapeutic programs; efforts to seek collaboration partners, including without limitation for our biosimilar programs; the timing of clinical trials and the availability of results; the significance and meaning of results of clinical trials, including without limitation, results from our necuparanib clinical trial; the timing of launch of products and product candidates; GLATOPA® (glatiramer acetate injection) product revenues and market potential; the timing and outcome of litigation and legal proceedings; collaboration revenues and research and development revenues; manufacturing, including our intent to rely on contract manufacturers; regulatory filings, reviews and approvals; the sufficiency of our cash for future operations; our expectations regarding our potential future profitability; our intended uses of proceeds from financing activities; Enoxaparin Sodium Injection product revenues and market potential; our expectations regarding product candidate development costs; our expectations regarding receipt of contingent milestone payments from Mylan Ireland Limited in 2016; accounting policies; our estimates regarding the fair value of our investment portfolio; and our market risk exposure with respect to derivative, foreign currency and other financial instruments.

Any forward-looking statements in this Quarterly Report on Form 10-Q involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Important factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Part II, Item 1A. “Risk Factors” and discussed elsewhere in this Quarterly Report on Form 10-Q. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

MOMENTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except per share amounts)

(unaudited)

	March 31, 2016			December 31, 2015
Assets
Current assets:
Cash and cash equivalents	$	89,431		$	61,461
Marketable securities	256,359			288,583
Collaboration receivable	21,742			21,185
Prepaid expenses and other current assets	4,405			3,479
Total current assets	371,937			374,708
Marketable securities	17,038			—
Property and equipment, net	21,547			21,896
Restricted cash	20,660			20,660
Intangible assets, net	3,263			3,528
Other long-term assets	978			248

Total assets	$	435,423		$	421,040

Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	3,388		$	4,053
Accrued expenses	16,231			24,499
Deferred revenue	17,144			9,770
Other current liabilities	110			460
Total current liabilities	36,873			38,782
Deferred revenue, net of current portion	46,475			12,213
Other long-term liabilities	592			69

Total liabilities	83,940			51,064
Commitments and contingencies (Note 8)
Stockholders’ Equity:
Preferred stock, $0.01 par value per share; 5,000 shares authorized, 100 shares of Series A Junior Participating Preferred Stock, $0.01 par value per share designated and no shares issued and outstanding	—			—
Common stock, $0.0001 par value per share; 100,000 shares authorized, 69,495 shares issued and 69,376 shares outstanding at March 31, 2016 and 69,077 shares issued and 68,958 outstanding at December 31, 2015	7			7
Additional paid-in capital	829,771			824,385
Accumulated other comprehensive income	137			4
Accumulated deficit	(476,384		)	(452,372		)
Treasury stock, at cost, 119 shares	(2,048		)	(2,048		)

Total stockholders’ equity	351,483			369,976

Total liabilities and stockholders’ equity	$	435,423		$	421,040

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

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MOMENTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except per share amounts)

(unaudited)

	Three Months Ended March 31,
	2016			2015
Collaboration revenues:
Product revenue	$	14,800		$	2,722
Research and development revenue	5,050			5,840
Total collaboration revenue	19,850			8,562

Operating expenses:
Research and development*	28,757			22,749
General and administrative*	15,647			7,890
Total operating expenses	44,404			30,639

Operating loss	(24,554		)	(22,077		)

Other income:
Interest income	480			112
Other income	62			88
Total other income	542			200

Net loss	$	(24,012	)	$	(21,877	)

Basic and diluted net loss per share	$	(0.35	)	$	(0.40	)

Weighted average shares used in computing basic and diluted net loss per share	68,285			54,492

Comprehensive loss:
Net loss	$	(24,012	)	$	(21,877	)
Net unrealized holding gains on available-for-sale marketable securities	133			18
Comprehensive loss	$	(23,879	)	$	(21,859	)

* Non-cash share-based compensation expense (income) included in operating expenses is as follows:

Research and development		$	2,065		$	(2,215	)
General and administrative		$	2,763		$	(2,170	)

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

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MOMENTA PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

	Three Months Ended March 31,
	2016			2015
Cash Flows from Operating Activities:
Net loss	$	(24,012	)	$	(21,877	)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Non-cash items:
Depreciation and amortization	1,889			2,089
Share-based compensation expense (income)	4,828			(4,385		)
Amortization of premium on investments	290			304
Amortization of intangibles	265			265
Changes in operating assets and liabilities:
Collaboration receivable	(557		)	1,665
Prepaid expenses and other current assets	(926		)	157
Other long-term assets	(730		)	—
Accounts payable	(665		)	(1,939		)
Accrued expenses	(8,268		)	(3,037		)
Deferred revenue	41,636			(1,687		)
Other current liabilities	(350		)	20
Other long-term liabilities	523			(151		)

Net cash provided by (used in) operating activities	13,923			(28,576		)

Cash Flows from Investing Activities:
Purchases of property and equipment	(1,540		)	(539		)
Purchases of marketable securities	(119,368		)	(15,694		)
Proceeds from maturities of marketable securities	134,397			44,492

Net cash provided by investing activities	13,489			28,259

Cash Flows from Financing Activities:
Net proceeds from issuance of common stock under ATM facilities	—			33,665
Proceeds from issuance of common stock under stock plans	558			2,911

Net cash provided by financing activities	558			36,576

Increase in cash and cash equivalents	27,970			36,259
Cash and cash equivalents, beginning of period	61,461			61,349

Cash and cash equivalents, end of period	$	89,431		$	97,608

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

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MOMENTA PHARMACEUTICALS, INC.

NOTES TO UNAUDITED, CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

1. The Company

Business

Momenta Pharmaceuticals, Inc., or the Company or Momenta, was incorporated in the state of Delaware in May 2001 and began operations in early 2002. Its facilities are located in Cambridge, Massachusetts. Momenta is a biotechnology company focused on developing generic versions of complex drugs, biosimilars and novel therapeutics for oncology and autoimmune disease. The Company presently derives all of its revenue from its collaborations.

2. Summary of Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

The Company’s accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, applicable to interim periods and, in the opinion of management, include all normal and recurring adjustments that are necessary to state fairly the results of operations for the reported periods. The Company’s condensed consolidated financial statements have also been prepared on a basis substantially consistent with, and should be read in conjunction with, the Company’s audited consolidated financial statements for the year ended December 31, 2015, which were included in the Company’s Annual Report on Form 10-K that was filed with the Securities and Exchange Commission, or SEC, on February 26, 2016. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. The results of the Company’s operations for any interim period are not necessarily indicative of the results of the Company’s operations for any other interim period or for a full fiscal year.

The accompanying condensed consolidated financial statements reflect the operations of the Company and the Company’s wholly-owned subsidiary Momenta Pharmaceuticals Securities Corporation. All significant intercompany accounts and transactions have been eliminated.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates and judgments, including those related to revenue recognition, accrued expenses, and share-based payments. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates.

Revenue Recognition

The Company recognizes revenue when persuasive evidence of an arrangement exists; services have been performed or products have been delivered; the fee is fixed or determinable; and collection is reasonably assured.

The Company has entered into collaboration and license agreements with pharmaceutical companies for the development and commercialization of certain of its product candidates. The Company’s performance obligations under the terms of these agreements may include (i) transfer of intellectual property rights (licenses), (ii) providing research and development services, and (iii) participation on joint steering committees with the collaborators. Non-refundable payments to the Company under these agreements may include up-front license fees, payments for research and development activities, payments based upon the achievement of defined collaboration objectives and profit share or royalties on product sales.

At March 31, 2016, the Company had collaboration and license agreements with Sandoz AG (formerly Sandoz N.V. and Biochemie West Indies, N.V.), an affiliate of Novartis Pharma AG, and Sandoz Inc. (formerly Geneva Pharmaceuticals, Inc.), collectively referred to as Sandoz, Sandoz AG, Baxalta U.S. Inc., Baxalta GmbH and Baxalta Incorporated, collectively referred to as Baxalta, and Mylan Ireland Limited, a wholly-owned, indirect subsidiary of Mylan N.V., or Mylan.

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arrangements under ASU 2009-13, the Company identifies the deliverables included within the agreement and determines whether the deliverables under the arrangement represent separate units of accounting. Deliverables under the arrangement are a separate unit of accounting if (i) the delivered item has value to the customer on a standalone basis and (ii) if the arrangement includes a general right of return relative to the delivered item and delivery or performance of the undelivered items are considered probable and substantially within the Company’s control. This evaluation requires subjective determinations and requires management to make judgments about the individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship. In determining the units of accounting, management evaluates certain criteria, including whether the deliverables have standalone value, based on the consideration of the relevant facts and circumstances for each arrangement. The Company considers whether the collaborator can use the license or other deliverables for their intended purpose without the receipt of the remaining elements, and whether the value of the deliverable is dependent on the undelivered items and whether there are other vendors that can provide the undelivered items.

Arrangement consideration generally includes up-front license fees and non-substantive options to purchase additional products or services. The Company determines how to allocate arrangement consideration to identified units of accounting based on the selling price hierarchy provided under the relevant guidance. The Company determines the estimated selling price for deliverables using vendor-specific objective evidence, or VSOE, of selling price, if available, third-party evidence, or TPE, of selling price if VSOE is not available, or best estimate of selling price, or BESP, if neither VSOE nor TPE is available. Determining the BESP for a deliverable requires significant judgment. The Company uses BESP to estimate the selling price for licenses to the Company’s proprietary technology, since the Company often does not have VSOE or TPE of selling price for these deliverables. In those circumstances where the Company utilizes BESP to determine the estimated selling price of a license to the Company’s proprietary technology, the Company considers entity specific factors, including those factors contemplated in negotiating the agreements as well as the license fees negotiated in similar license arrangements. Management may be required to exercise considerable judgment in estimating the selling prices of identified units of accounting under its agreements. In validating the Company’s BESP, the Company evaluates whether changes in the key assumptions used to determine the BESP will have a significant effect on the allocation of arrangement consideration between multiple deliverables.

Up-Front License Fees

Up-front payments received in connection with licenses of the Company’s technology rights are deferred if facts and circumstances dictate that the license does not have stand-alone value. When management believes the license to its intellectual property does not have stand-alone value from the other deliverables to be provided in the arrangement, it is combined with other deliverables and the revenue of the combined unit of accounting is recorded based on the method appropriate for the last delivered item. The Company recognizes revenue from non-refundable, up-front license fees on a straight-line basis over the contracted or estimated period of performance, which is typically the period over which the research and development services are expected to occur. Accordingly, the Company is required to make estimates regarding the development timelines for product candidates being developed pursuant to any applicable agreement. The determination of the length of the period over which to recognize the revenue is subject to judgment and estimation and can have an impact on the amount of revenue recognized in a given period. Quarterly, the Company reassesses its period of substantial involvement over which the Company amortizes its up-front license fees and makes adjustments as appropriate. The Company’s estimates regarding the period of performance under its collaborative research and development and licensing agreements have changed in the past and may change in the future. Any change in the Company’s estimates could result in changes to the Company’s results for the period over which the revenues from an up-front license fee are recognized.

Milestones

At the inception of each arrangement that includes milestone payments, the Company evaluates whether each milestone is substantive, in accordance with ASU No. 2010-17, Revenue Recognition—Milestone Method. A milestone is defined as an event that can only be achieved based on the Company’s performance, and there is substantive uncertainty about whether the event will be achieved at the inception of the arrangement. Events that are contingent only on the passage of time or only on counterparty performance are not considered milestones under accounting guidance. This evaluation includes an assessment of whether (a) the consideration is commensurate with either (1) the Company’s performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the Company’s performance to achieve the milestone, (b) the consideration relates solely to past performance (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement and (d) the milestone fee is refundable or adjusts based on future performance or non-performance. The Company evaluates factors such as the scientific, clinical, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. 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, assuming all other revenue recognition criteria are met. At March 31, 2016, the Company had no milestones under its collaborative arrangements that were deemed substantive.

The regulatory milestones under the collaboration with Baxalta are considered to be contingent fees that will be recorded if earned in future periods.

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Sales-based and commercial milestones are accounted for as royalties and are recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met.

Profit Share and Royalties on Sandoz’ Sales of Enoxaparin Sodium Injection® and GLATOPA®

Profit share and royalty revenue is reported as product revenue and is recognized based upon net sales or contractual profit of licensed products in licensed territories in the period the sales occur as provided by the collaboration agreement. The amount of net sales or contractual profit is determined based on amounts provided by the collaborator and involve the use of estimates and judgments, such as product sales allowances and accruals related to prompt payment discounts, chargebacks, governmental and other rebates, distributor, wholesaler and group purchasing organizations fees, product returns, and co-payment assistance costs, which could be adjusted based on actual results in the future. The Company is highly dependent on its collaborators for timely and accurate information regarding any net revenues realized from sales of Enoxaparin Sodium Injection and GLATOPA in order to accurately report its results of operations.

Research and Development Revenue under Collaborations with Sandoz and Baxalta

Under its collaborations with Sandoz and Baxalta, the Company is reimbursed at a contractual full-time equivalent, or FTE, rate for any FTE employee expenses as well as any external costs incurred for commercial and related activities. The Company recognizes research and development revenue from FTE services and external costs upon completion of the performance requirements (i.e., as the services are performed and the reimbursable costs are incurred). Revenues are recorded on a gross basis as the Company contracts directly with, manages the work of and is responsible for payments to third-party vendors for such commercial and related services.

Collaboration Receivable

Collaboration receivable represents:

· Amounts due to the Company for profit share on Sandoz’ sales of Enoxaparin Sodium Injection and GLATOPA;

· Amounts due to the Company for reimbursement of research and development services and external costs under the collaborations with Sandoz and Baxalta; and

· The net amount due from Mylan for its 50% share of collaboration expenses under the cost-sharing arrangement.

The Company has not recorded any allowance for uncollectible accounts or bad debt write-offs and it monitors its receivables to facilitate timely payment.

Deferred Revenue

Deferred revenue represents consideration received from collaborators in advance of achieving certain criteria that must be met for revenue to be recognized in conformity with GAAP.

Net Loss Per Common Share

The Company computes basic net loss per common share by dividing net loss by the weighted average number of common shares outstanding, which includes common stock issued and outstanding and excludes unvested shares of restricted common stock. The Company computes diluted net loss per common share by dividing net loss by the weighted average number of common shares and potential shares from outstanding stock options and unvested restricted stock determined by applying the treasury stock method.

The following table presents anti-dilutive shares for the three months ended March 31, 2016 and 2015 (in thousands):

	Three Months Ended March 31,
	2016	2015
Weighted-average anti-dilutive shares related to:
Outstanding stock options	6,659	6,519
Restricted stock awards	335	685

Since the Company had a net loss for all periods presented, the effect of all potentially dilutive securities is anti-dilutive. Accordingly, basic and diluted net loss per share is the same for the three months ended March 31, 2016 and 2015. Anti-dilutive shares comprise the impact of the number of shares that would have been dilutive had the Company had net income plus the number of common stock equivalents that would be anti-dilutive had the Company had net income. Furthermore, 308,095 performance-based restricted common stock awards vested on April 18, 2016, the one year anniversary of the U.S. Food and Drug Administration, or FDA, approval for GLATOPA in the United States,

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were excluded from diluted shares outstanding as the vesting condition for the amended awards, discussed further in Note 6 “Share-Based Payments,” had not been met as of March 31, 2016.

Fair Value Measurements

The tables below present information about the Company’s assets that are regularly measured and carried at fair value as of March 31, 2016 and December 31, 2015, and indicate the level within the fair value hierarchy of the valuation techniques utilized to determine such fair value (in thousands):

Description	Balance as of March 31, 2016		Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Other Unobservable Inputs (Level 3)
Assets:
Cash equivalents:
Money market funds and overnight repurchase agreements	$	86,685	$	62,685	$	24,000	$	—
Marketable securities:
U.S. government-sponsored enterprise securities	4,999		—		4,999		—
Corporate debt securities	74,479		—		74,479		—
Commercial paper obligations	111,578		—		111,578		—
Asset-backed securities	82,341		—		82,341		—

Total	$	360,082	$	62,685	$	297,397	$	—

Description	Balance as of December 31, 2015		Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Other Unobservable Inputs (Level 3)
Assets:
Cash equivalents:
Money market funds and overnight repurchase agreements	$	54,077	$	30,077	$	24,000	$	—
Marketable securities:
U.S. government-sponsored enterprise securities	24,290		—		24,290		—
Corporate debt securities	73,651		—		73,651		—
Commercial paper obligations	125,805		—		125,805		—
Asset-backed securities	64,837		—		64,837		—

Total	$	342,660	$	30,077	$	312,583	$	—

There have been no impairments of the Company’s assets measured and carried at fair value during the three months ended March 31, 2016 and 2015. In addition, there were no changes in valuation techniques or transfers between the fair value measurement levels during the three months ended March 31, 2016. The fair value of Level 2 instruments classified as marketable securities were determined through third party pricing services. For a description of the Company’s validation procedures related to prices provided by third party pricing services, refer to Note 2 “ Summary of Significant Accounting Policies: Fair Value Measurements “ to the Company’s consolidated financial statements in its Annual Report on Form 10-K for the year ended December 31, 2015. The carrying amounts reflected in the Company’s accompanying condensed consolidated balance sheets for cash, accounts receivable, unbilled receivables, other current assets, accounts payable and accrued expenses approximate fair value due to their short-term maturities.

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Cash, Cash Equivalents and Marketable Securities

The Company’s cash equivalents are primarily composed of money market funds carried at fair value, which approximates cost at March 31, 2016 and December 31, 2015. The Company classifies corporate debt securities, commercial paper, asset-backed securities and U.S. government-sponsored enterprise securities as short-term and long-term marketable securities in its consolidated financial statements. See Note 2 “Summary of Significant Accounting Policies: Cash, Cash Equivalents and Marketable Securities” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 for a discussion of the Company’s accounting policies.

The following tables summarize the Company’s cash, cash equivalents and marketable securities as of March 31, 2016 and December 31, 2015 (in thousands):

As of March 31, 2016	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
Cash, money market funds and overnight repurchase agreements	$	89,431	$	—	$	—		$	89,431
U.S. government-sponsored enterprise securities due in one year or less	4,998		1		—			4,999
Corporate debt securities due in one year or less	74,473		8		(2		)	74,479
Commercial paper obligations due in one year or less	111,449		129		—			111,578
Asset-backed securities due in one year or less	65,302		15		(14		)	65,303
Asset-backed securities due in two years or less	17,038		4		(4		)	17,038

Total	$	362,691	$	157	$	(20	)	$	362,828

Reported as:
Cash and cash equivalents	$	89,431	$	—	$	—		$	89,431
Marketable securities	273,260		157		(20		)	273,397

Total	$	362,691	$	157	$	(20	)	$	362,828

As of December 31, 2015	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
Cash, money market funds and overnight repurchase agreements	$	61,461	$	—	$	—		$	61,461
U.S. government-sponsored enterprise securities due in one year or less	24,285		5		—			24,290
Corporate debt securities due in one year or less	73,735		1		(84		)	73,652
Commercial paper obligations due in one year or less	125,693		120		(8		)	125,805
Asset-backed securities due in one year or less	64,866		—		(30		)	64,836

Total	$	350,040	$	126	$	(122	)	$	350,044

Reported as:
Cash and cash equivalents	$	61,461	$	—	$	—		$	61,461
Marketable securities	288,579		126		(122		)	288,583

Total	$	350,040	$	126	$	(122	)	$	350,044

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At March 31, 2016 and December 31, 2015, the Company held 11 and 66 marketable securities, respectively, that were in a continuous unrealized loss position for less than one year. At March 31, 2016 and December 31, 2015, there were no securities in a continuous unrealized loss position for greater than one year. The Company believes the unrealized losses were caused by fluctuations in interest rates.

The following table summarizes the aggregate fair value of these securities as of March 31, 2016 and December 31, 2015 (in thousands):

	As of March 31, 2016					As of December 31, 2015
	Aggregate Fair Value		Unrealized Losses			Aggregate Fair Value		Unrealized Losses
Corporate debt securities due in one year or less	$	20,024	$	(2	)	$	70,657	$	(84	)
Commercial paper obligations due in one year or less	$	—	$	—		$	33,734	$	(8	)
Asset-backed securities due in one year or less	$	22,944	$	(14	)	$	61,337	$	(30	)
Asset-backed securities due in two years or less	$	8,015	$	(4	)	$	—	$	—

Treasury Stock

Treasury stock represents common stock currently owned by the Company as a result of shares withheld from the vesting of performance-based restricted common stock to satisfy minimum tax withholding requirements.

Comprehensive Income (Loss)

Comprehensive income (loss) is the change in equity of a company during a period from transactions and other events and circumstances, excluding transactions resulting from investments by owners and distributions to owners. Comprehensive income (loss) includes net (loss) income and the change in accumulated other comprehensive income (loss) for the period. Accumulated other comprehensive income (loss) consists entirely of unrealized gains and losses on available-for-sale marketable securities for all periods presented.

New Accounting Pronouncements

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes all existing revenue recognition requirements, including most industry-specific guidance. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the company expects to receive for those goods or services. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, which delayed the effective date of the new standard from January 1, 2017 to January 1, 2018. The FASB also agreed to allow entities to choose to adopt the standard as of the original effective date. The Company is currently evaluating the method of adoption and the potential impact that Topic 606 may have on its financial position and results of operations.

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periods after December 15, 2016, and will not have a material impact on the consolidated financial statements, but may impact the Company’s footnote disclosures regarding liquidity.

In November 2015, the FASB issued ASU No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes. The new standard requires that deferred tax assets and liabilities be classified as noncurrent in a classified statement of financial position. The adoption of this standard in the first quarter of 2016 did not have a material impact on the Company’s financial position or results of operations as its net deferred tax assets have been fully offset by a valuation allowance.

In March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations (Reporting Revenue Gross versus Net). This new standard relates to when another party, along with the entity, is involved in providing a good or a service to a customer. In those circumstances, Topic 606 requires the entity to determine whether the nature of its promise is to provide that good or service to the customer (that is, the entity is a principal) or to arrange for the good or service to be provided to the customer by the other party (that is, the entity is an agent). This determination is based upon whether the entity controls the good or the service before it is transferred to the customer. The Company will adopt this new standard concurrently with adoption of ASU No. 2014-09.

In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. Under the new standard all excess tax benefits and tax deficiencies should be recognized as income tax expense or benefit in the income statement. The tax effects of exercised or vested awards should be treated as discrete items in the reporting period in which they occur. An entity also should recognize excess tax benefits regardless of whether the benefit reduces taxes payable in the current period. The new standard also provides for companies to make an entity-wide accounting policy election on how to account for award forfeitures. Entities can either estimate the number of awards that are expected to vest (current GAAP) or account for forfeitures when they occur. The accounting standard is effective for interim and annual periods after December 15, 2016. Early adoption is permitted for any entity in any interim or annual period. The Company is currently evaluating the impact of adopting this new accounting standard on its financial position and results of operations.

3. Intangible Assets

Intangible assets consist solely of core developed technology acquired as part of a 2007 asset purchase agreement with Parivid LLC. See Part I, Item 1 “Business—Collaborations, Licenses and Asset Purchases—Parivid” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 for relevant disclosures. The developed technology intangible assets are being amortized over the estimated useful life of the Enoxaparin Sodium Injection and GLATOPA developed technologies of approximately 10 years. As of March 31, 2016 and December 31, 2015, intangible assets, net of accumulated amortization, were as follows (in thousands):

	March 31, 2016							December 31, 2015
	Gross Carrying Amount		Accumulated Amortization			Net Carrying Value		Gross Carrying Amount		Accumulated Amortization			Net Carrying Value
Total intangible assets for core and developed technology and non-compete agreement	$	10,427	$	(7,164	)	$	3,263	$	10,427	$	(6,899	)	$	3,528

The weighted-average amortization period for the Company’s intangible assets is 10 years. Amortization is computed using the straight-line method over the useful lives of the respective intangible assets as there is no other pattern of use that is reasonably estimable. Amortization expense was approximately $0.3 million for each of the three months ended March 31, 2016 and 2015.

The Company expects to incur amortization expense of approximately $1.1 million per year for each of the next three years and $0.1 million in the fourth year.

4. Restricted Cash

The Company designated $17.5 million as collateral for a security bond posted in the litigation against Amphastar, International Medical Systems, Ltd., a wholly owned subsidiary of Amphastar Pharmaceuticals, Inc. and Actavis, Inc. (formerly Watson Pharmaceuticals, Inc.), or Actavis, as discussed within Note 8, “Commitments and Contingencies”. Amphastar, International Medical Systems, Ltd. and Amphastar Pharmaceuticals, Inc. are collectively referred to as Amphastar. The $17.5 million is held in an escrow account by Hanover Insurance. The Company classified this restricted cash as long-term as the timing of a final decision in the Enoxaparin Sodium Injection patent litigation is not known.

The Company designated $2.4 million as collateral for a letter of credit related to the lease of office and laboratory space located at 675 West Kendall Street in Cambridge, Massachusetts. This balance will remain restricted through April 2018 and therefore is classified as non-current in the Company’s consolidated balance sheet. The Company will earn interest on the balance.

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The Company designated $0.7 million as collateral for a letter of credit related to the lease of office and laboratory space located at 320 Bent Street in Cambridge, Massachusetts. This balance will remain restricted through the lease term and during any lease term extensions. The Company will earn interest on the balance.

5. Collaboration and License Agreements

At March 31, 2016, the Company had collaboration and license agreements with Sandoz, Sandoz AG, Baxalta and Mylan.

The Company records product revenue based on Sandoz’ sales of Enoxaparin Sodium Injection and GLATOPA.

Research and development revenue generally consists of amounts earned by us under our collaborations for technical development, regulatory and commercial milestones; reimbursement of research and development services and reimbursement of development costs under our collaborative arrangements with Sandoz and Baxalta; and recognition of the arrangement consideration under the collaborations with Baxalta and Mylan.

The collaboration with Mylan is a cost-sharing arrangement pursuant to which reimbursement for Mylan’s 50% share of collaboration expenses is recorded as a reduction to research and development expense and general and administrative expense depending on the nature of the activities.

The following tables provide amounts by year and by line item included in the Company’s accompanying condensed consolidated statements of operations and comprehensive loss attributable to transactions arising from its significant collaborative arrangements and all other arrangements, as defined in the Financial Accounting Standards Board’s Accounting Standards Codification Topic 808, Collaborative Arrangements. The dollar amounts in the tables below are in thousands.

	For the Three Months Ended March 31, 2016
	2003 Sandoz Collaboration Agreement		2006 Sandoz Collaboration Agreement		Baxalta Collaboration Agreement		Mylan Collaboration Agreement (1)		Total Collaborations
Collaboration revenues:
Product revenue	$	—	$	14,800	$	—	$	—	$	14,800
Research and development revenue:
Recognition of upfront payments and license payments	—		—		2,442		922		3,364
Research and development services and external costs under Sandoz and Baxalta collaborations	77		645		964		—		1,686
Total research and development revenue	$	77	$	645	$	3,406	$	922	$	5,050
Total collaboration revenues	$	77	$	15,445	$	3,406	$	922	$	19,850
Operating expenses:
Research and development expense(2)(3)	$	—	$	293	$	314	$	3,680	$	4,287
General and administrative expense(2)(3)	$	1,064	$	95	$	282	$	112	$	1,553
Total operating expenses	$	1,064	$	388	$	596	$	3,792	$	5,840

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	For the Three Months Ended March 31, 2015
	2003 Sandoz Collaboration Agreement		2006 Sandoz Collaboration Agreement		Baxalta Collaboration Agreement		Total Collaborations
Collaboration revenues:
Product revenue	$	2,722	$	—	$	—	$	2,722
Research and development revenue:
Milestone payments	—		—		—		—
Recognition of upfront payments and license payments	—		—		1,686		1,686
Research and development services and external costs	251		684		3,219		4,154
Total research and development revenue	$	251	$	684	$	4,905	$	5,840
Total collaboration revenues	$	2,973	$	684	$	4,905	$	8,562
Operating expenses:
Research and development expense(2)	$	31	$	148	$	608	$	787
General and administrative expense(2)	$	110	$	77	$	406	$	593
Total operating expenses	$	141	$	225	$	1,014	$	1,380

(1) The Mylan Collaboration Agreement, as defined below, became effective on February 9, 2016.

(2) The amounts represent external expenditures, including amortization of an intangible asset, and exclude salaries and benefits, share-based compensation, facilities, depreciation and laboratory supplies, as the majority of such costs are not directly charged to programs.

(3) As a result of the cost-sharing provisions of the Mylan Collaboration Agreement, the Company offset approximately $3.7 million against research and development costs and $0.1 million against general and administrative costs during the three months ended March 31, 2016.

2003 Sandoz Collaboration Agreement

In 2003, the Company entered into a collaboration and license agreement, or the 2003 Sandoz Collaboration Agreement, with Sandoz to jointly develop, manufacture and commercialize Enoxaparin Sodium Injection, a generic version of LOVENOX®, in the United States. Under the terms of the 2003 Sandoz Collaboration Agreement, the Company and Sandoz agreed to exclusively work with each other to develop and commercialize Enoxaparin Sodium Injection for any and all medical indications within the United States. In addition, the Company granted Sandoz an exclusive license under its intellectual property rights to develop and commercialize injectable enoxaparin for all medical indications within the United States.

Sandoz began selling Enoxaparin Sodium Injection in July 2010. For the three months ended March 2015, the Company received a 10% royalty on net sales. In June 2015, the Company and Sandoz amended the 2003 Sandoz Collaboration Agreement, effective April 1, 2015, to provide that Sandoz would pay the Company 50% of contractually-defined profits on sales. Sandoz did not record any profit on sales of Enoxaparin Sodium Injection in the three months ended March 31, 2016, and therefore the Company did not record product revenue for Enoxaparin Sodium Injection in the period. See “Product revenue” in the table above for product revenue earned by the Company in the three months ended March 31, 2015 on Sandoz’ sales of Enoxaparin Sodium Injection.

A portion of Enoxaparin Sodium Injection development expenses and certain legal expenses, which in the aggregate have exceeded a specified amount, are offset against profit-sharing amounts, royalties and milestone payments. The Company’s contractual share of such development and legal expenses is subject to an annual claw-back adjustment at the end of each of the first five product years, with the product year beginning on July 1 and ending on June 30. The annual adjustment can only reduce the Company’s profits, royalties and milestones by up to 50% in a given calendar quarter and any excess amount due will be carried forward into future quarters and reduce any profits in those future periods until it is paid in full. Annual adjustments, including amounts carried forward into future periods, are recorded as a reduction in product revenue.

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2006 Sandoz Collaboration Agreement

In 2006 and 2007, the Company entered into a series of agreements, including a collaboration and license agreement, as amended, or the 2006 Sandoz Collaboration Agreement, with Sandoz AG; and a stock purchase agreement and an investor rights agreement, with Novartis. Under the 2006 Sandoz Collaboration Agreement, the Company and Sandoz AG agreed to exclusively collaborate on the development and commercialization of GLATOPA and M356, among other products. Costs, including development costs and the costs of clinical studies, will be borne by the parties in varying proportions depending on the type of expense. For GLATOPA and M356, the Company is generally responsible for all of the development costs in the United States. For GLATOPA and M356 outside of the United States, the Company shares development costs in proportion to its profit sharing interest. The Company is reimbursed at a contractual FTE rate for any FTE employee expenses as well as any external costs incurred in the development of products to the extent development costs are born by Sandoz. All commercialization costs are borne by Sandoz.

Sandoz commenced sales of GLATOPA in the United States on June 18, 2015. Under the 2006 Sandoz Collaboration Agreement, the Company earns 50% of contractually-defined profits on Sandoz’ worldwide net sales of GLATOPA. The Company is entitled to earn 50% of contractually-defined profits on Sandoz’ worldwide net sales of M356, if and when M356 is commercialized. Profits on net sales of GLATOPA and M356 are calculated by deducting from net sales the costs of goods sold and an allowance for selling, general and administrative costs, which is a contractual percentage of net sales. Sandoz is responsible for funding all of the legal expenses incurred under the 2006 Sandoz Collaboration Agreement; however a portion of certain legal expenses, including any patent infringement damages, can be offset against the profit-sharing amounts in proportion to the Company’s 50% profit sharing interest.

For the three months ended March 31, 2016, the Company recorded $14.8 million in product revenues from Sandoz’ sales of GLATOPA. The Company is eligible to receive in the aggregate up to $120.0 million in additional milestone payments upon the achievement of certain commercial and sales-based milestones for GLATOPA and M356 in the United States. None of these payments, once received, is refundable and there are no general rights of return in the arrangement. Sandoz AG has agreed to indemnify the Company for various claims, and a certain portion of such costs may be offset against certain future payments received by the Company.

The term of the 2006 Sandoz Collaboration Agreement extends throughout the development and commercialization of the products until the last sale of the products, unless earlier terminated by either party pursuant to the provisions of the 2006 Sandoz Collaboration Agreement. The 2006 Sandoz Collaboration Agreement may be terminated if either party breaches the 2006 Sandoz Collaboration Agreement or files for bankruptcy. In addition, either the Company or Sandoz AG may terminate the 2006 Sandoz Collaboration Agreement with respect to M356, if clinical trials are required for regulatory approval of M356.

Baxalta Collaboration Agreement

The Company and Baxter International Inc., Baxter Healthcare Corporation and Baxter Healthcare SA, collectively referred to as Baxter, entered into a global collaboration and license agreement effective February 2012, or the Baxter Collaboration Agreement, to develop and commercialize biosimilars, including M923. In connection with Baxter’s internal corporate restructuring in July 2015, Baxter assigned all of its rights and obligations under the Baxter Collaboration Agreement to Baxalta. In light of the assignment, all references to Baxter and the Baxter Collaboration Agreement have been replaced with references to Baxalta and the Baxalta Collaboration Agreement, respectively.

Under the Baxalta Collaboration Agreement, the Company and Baxalta agreed to collaborate, on a world-wide basis, on the development and commercialization of M923, the Company’s biosimilar HUMIRA® (adalimumab) candidate, and M834, the Company’s biosimilar ORENCIA® (abatacept) candidate, and Baxalta had the right to select four additional reference products to target for biosimilar development under the collaboration. In July 2012, Baxalta selected an additional product: M511, the Company’s biosimilar AVASTIN® (bevacizumab) candidate. In December 2013, Baxalta terminated its option to license M511 under the Baxalta Collaboration Agreement following an internal portfolio review. In February 2015, Baxalta’s right to select additional programs expired without being exercised. Also in February 2015, Baxalta terminated in part the Baxalta Collaboration Agreement as it relates specifically to M834 and all worldwide development and commercialization rights for M834 reverted to the Company. The Baxalta Collaboration Agreement remains in effect and unchanged with respect to M923.

Under the Baxalta Collaboration Agreement, each party has granted the other an exclusive license under its intellectual property rights to develop and commercialize M923 for all therapeutic indications. The Company has agreed to provide development and related services on a commercially reasonable basis through the filing of an Investigational New Drug application, or IND, or equivalent application in the European Union for M923. Development and related services include high-resolution analytics, characterization, and product and process development. Baxalta is responsible for clinical development, manufacturing and commercialization activities and will exclusively distribute and market M923. The Company has the right to participate in a joint steering committee, consisting of an equal number of members from the Company and Baxalta, to oversee and manage the development and commercialization of M923 under the collaboration. Costs, including development costs, payments to third parties for intellectual property licenses, and expenses for legal proceedings, including the patent exchange process pursuant to the Biologics Price Competition and Innovation Act of 2009, will be borne by the parties in varying proportions, depending on the type of expense and the stage of development. The Company is reimbursed at a contractual FTE rate for any FTE employee expenses and external development costs for reimbursable activities related to M923.

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Baxalta has a right of first negotiation with respect to collaborating with the Company on the development of any biosimilar product candidate that could compete with M923 based on the same mechanism of action. This right is effective until December 2017, subject to certain restrictions as outlined in the Baxalta Collaboration Agreement. Under the terms of the Baxter Agreement, the Company received an initial cash payment of $33.0 million, a $7.0 million license payment for achieving pre-defined “minimum development criteria” for M834, and $12.0 million in technical and development milestone payments in connection with the UK Medicines and Healthcare Products Regulatory Agency’s acceptance of Baxalta’s clinical trial application to initiate a pharmacokinetic clinical trial for M923. The Company is eligible to receive from Baxalta, in aggregate, up to $50.0 million in regulatory milestone payments for M923, on a sliding scale, where, based on the product’s regulatory application, there is a significant reduction in the scope of the clinical trial program required for regulatory approval.

In addition, if M923 is successfully developed and launched, Baxalta will be required to pay to the Company royalties on net sales of licensed products worldwide, with a base royalty rate in the high single digits with the potential for significant tiered increases based on the number of competitors, the interchangeability of the product, and the sales tier for the product. The maximum royalty with all potential increases would be slightly more than double the base royalty.

The term of the collaboration shall continue throughout the development and commercialization of M923 on a country-by-country basis until there is no remaining payment obligation with respect to the product in the relevant territory, unless earlier terminated by either party pursuant to the terms of the Baxalta Collaboration Agreement.

The Baxalta Collaboration Agreement may be terminated by:

· either party for breach by or bankruptcy of the other party;

· Baxalta for its convenience; or

· the Company in the event Baxalta does not exercise commercially reasonable efforts to commercialize M923 in the United States or other specified countries, provided that the Company also has certain rights to directly commercialize M923, as opposed to terminating the Baxalta Collaboration Agreement, in event of such a breach by Baxalta.

In accordance with FASB’s ASU No. 2009-13: Multiple-Deliverable Revenue Arrangements (Topic 615), the Company identified the deliverables at the inception of the Baxalta Collaboration Agreement. The deliverables were determined to include (i) six development and product licenses, for each of M923, M834 and the four additional collaboration products, (ii) research and development services related to each of M923, M834 and the four additional collaboration products and (iii) the Company’s participation in a joint steering committee. The Company determined that each of the license deliverables does not have stand-alone value apart from the related research and development services deliverables because (1) there are no other vendors selling similar, competing products on a stand-alone basis, (2) Baxalta does not have the contractual right to resell the license, and (3) Baxalta is unable to use the license for its intended purpose without the Company’s performance of research and development services. As such, the Company determined that with respect to this arrangement separate units of accounting exist for each of the six licenses together with the related research and development services, as well as the one unit of accounting for the joint steering committee. The estimated selling price for these units of accounting was determined based on similar license arrangements and the nature of the research and development services to be performed for Baxalta and market rates for similar services. At the inception of the Baxalta Collaboration Agreement, arrangement consideration of $61.0 million, which included the $33.0 million upfront payment and aggregate option payments for the four additional collaboration products of $28.0 million, was allocated to the units of accounting based on the relative selling price method. Of the $61.0 million, $10.3 million was allocated to the M923 product license together with the related research and development services, $10.3 million to each of the four additional collaboration product licenses with the related research and development services, $9.4 million was allocated to the M834 product license together with the related research and development services due to that product’s stage of development at the time the license was delivered, and $114,000 was allocated to the joint steering committee unit of accounting.

At the inception of the Baxalta Collaboration Agreement, the Company delivered development and product licenses for M923 and M834 and commenced revenue recognition of the arrangement consideration allocated to those products. In addition, the Company began revenue recognition for the arrangement consideration allocated to the joint steering committee unit of accounting. Baxalta’s termination of its option to license M511 in December 2013 as well as its termination of M834 and the lapsing of its right to select additional products in February 2015 reduced the number of deliverables from seven to two and decreased the total consideration from $61.0 million to $40.0 million. The Company determined that the change in total consideration received and total deliverables under the arrangement represented a change in estimate and, as a result, the Company reallocated the revised total consideration of $40.0 million to the remaining deliverables under the agreement using the original best estimate of selling price. The remaining deliverables are the combined unit of account for the M923 license and the related research and development services and the Company’s participation on the joint steering committee. Of the $40.0 million, $39.6 million was allocated to the M923 product license together with the related research and development services and $0.4 million was allocated to the joint steering committee unit of accounting. The Company recognized the resulting change in revenue as a result of the decrease in deliverables and expected consideration on a prospective basis beginning in the first quarter of 2015. The Company records this revenue on a straight-line basis over the applicable performance period, which begins upon delivery of the development and product license and ends upon FDA approval of the product. The Company currently estimates that the performance period for M923 and for the joint steering committee is approximately six

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years. As of March 31, 2016, $19.5 million of revenue was deferred under this agreement, of which $9.8 million was included in current liabilities and $9.7 million was included in non-current liabilities in the consolidated balance sheet.

The regulatory milestones, along with any associated royalty or profit sharing payments, will be considered contingent fees that will be recorded as earned in future periods.

Mylan Collaboration Agreement

On January 8, 2016, the Company and Mylan entered into a collaboration agreement, or the Mylan Collaboration Agreement, which became effective on February 9, 2016, pursuant to which the Company and Mylan agreed to collaborate exclusively, on a world-wide basis, to develop, manufacture and commercialize six of the Company’s biosimilar candidates, including M834.

Under the terms of the Mylan Collaboration Agreement, Mylan agreed to pay the Company a non-refundable upfront payment of $45 million. In addition, the Company and Mylan share equally costs (including development, manufacturing, commercialization and certain legal expenses) and profits (losses) with respect to such product candidates, with Mylan funding its share of collaboration expenses incurred by the Company, in part, through up to six contingent milestone payments, totaling up to $200 million across the six product candidates.

For each product candidate other than M834, at a specified stage of early development, the Company and Mylan will each decide, based on the product candidate’s development progress and commercial considerations, whether to continue the development, manufacture and commercialization of such product candidate under the collaboration or to terminate the collaboration with respect to such product candidate.

Under the Mylan Collaboration Agreement, the Company granted Mylan an exclusive license under the Company’s intellectual property rights to develop, manufacture and commercialize the product candidates for all therapeutic indications, and Mylan granted the Company a co-exclusive license under Mylan’s intellectual property rights for the Company to perform its development and manufacturing activities under the product work plans agreed by the parties, and to perform certain commercialization activities to be agreed by the joint steering committee for such product candidates if the Company exercises its co-commercialization option described below. The Company and Mylan established a joint steering committee consisting of an equal number of members from the Company and Mylan to oversee and manage the development, manufacture and commercialization of product candidates under the collaboration. Unless otherwise determined by the joint steering committee, it is anticipated that, in collaboration with the other party, (a) the Company will be primarily responsible for nonclinical development activities and initial clinical development activities for product candidates; additional (pivotal or Phase 3 equivalent) clinical development activities for M834; and regulatory activities for product candidates in the United States through regulatory approval; and (b) Mylan will be primarily responsible for additional (pivotal or Phase 3 equivalent) clinical development activities for product candidates other than M834; regulatory activities for the product candidates outside the United States; and regulatory activities for products in the United States after regulatory approval, when all marketing authorizations for the products in the United States will be transferred to Mylan. Mylan will commercialize any approved products, with the Company having an option to co-commercialize, in a supporting commercial role, any approved products in the United States. The joint steering committee is responsible for allocating responsibilities for other activities under the collaboration.

The term of the collaboration will continue throughout the development and commercialization of the product candidates, on a product-by-product and country-by-country basis, until development and commercialization by or on behalf of the Company and Mylan pursuant to the Mylan Collaboration Agreement has ceased for a continuous period of two years for a given product candidate in a given country, unless earlier terminated by either party pursuant to the terms of the Mylan Collaboration Agreement.

The Mylan Collaboration Agreement may be terminated by either party for breach by, or bankruptcy of, the other party; for its convenience; or for certain activities involving competing products or the challenge of certain patents. Other than in the case of a termination for convenience, the terminating party will have the right to continue the development, manufacture and commercialization of the terminated products in the terminated countries. In the case of a termination for convenience, the other party will have the right to continue. If a termination occurs, the licenses granted to the non-continuing party for the applicable product will terminate for the terminated country. Subject to certain terms and conditions, the party that has the right to continue the development or commercialization of a given product candidate may retain royalty-bearing licenses to certain intellectual property rights, and rights to certain data, for the continued development and sale of the applicable product in the country or countries for which termination applies.

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separate unit of accounting for participation in the joint steering committee. VSOE and TPE were not available for the combined units of accounting. As such, the Company determined BESP for the combined units of accounting based on an analysis of its existing license arrangements and other available data and the nature and extent of the research and development services to be performed. BESP for the joint steering committee unit of accounting was based on market rates for similar services. At the inception of the Mylan Collaboration Agreement, total arrangement consideration of $45 million was allocated to each of the units of accounting based on the relative selling price method. Of the $45 million, $8.2 million was allocated to the M834 combined unit of accounting, between $5.7 million and $9.0 million to the five additional combined units of accounting, considering the products’ stage of development at the time the licenses were delivered. $51,000 was allocated to the joint steering committee unit of accounting. Changes in the key assumptions used to determine BESP for the units of accounting would not have a significant effect on the allocation of arrangement consideration.

At the inception of the Mylan Collaboration Agreement, the Company delivered development and product licenses for all six collaboration products and commenced revenue recognition of the arrangement consideration allocated the respective units of accounting. In addition, the Company began revenue recognition for the arrangement consideration allocated to the joint steering committee unit of accounting. The Company is recording revenue on a straight-line basis over the applicable performance period during which the research and development services are expected to be delivered, which begins upon delivery of the development and product license and ends upon FDA approval of the product. The Company currently estimates that the performance period for the M834 unit of accounting is approximately four years, an average of approximately seven years for the additional five combined units of accounting and approximately eight years for the joint steering committee unit of accounting. As of March 31, 2016, of the $45 million in total arrangement consideration, $0.9 million was recognized as research and development revenue and $7.4 million was included in current liabilities and $36.7 million was included in non-current liabilities in the consolidated balance sheet.

As discussed above, the Mylan Collaboration Agreement became effective on February 9, 2016. Beginning on February 9, 2016, the Company shares collaboration expenses with Mylan and, as such, the net amount due from Mylan for its 50% share of collaboration expenses is recorded as a collaboration receivable in the consolidated balance sheet and a reduction in research and development and/or general and administrative expenses in the consolidated statement of operations and comprehensive loss, in accordance with the Company’s policy, which is consistent with the nature of the cost reimbursement. Collaboration costs incurred by the Company are recorded as research and development expense and/or general and administrative expense, depending on the nature of the activities, as incurred.

As discussed above, Mylan will fund a portion of its 50% share of collaboration expenses through up to $200 million in contingent milestone payments across the six product candidates. The contingent payments will reduce the collaboration receivable balance and any unused portion of the contingent payment will be available to offset Mylan’s 50% share of collaboration costs in future periods. If in a given year a contingent payment is not expected to be made by Mylan in a collaboration year and there is no balance available from a prior contingent payment balance as of the beginning of the collaboration year, the parties will reconcile total collaboration expenses on a semi-annual basis and Mylan will make a payment to the Company. For the quarter ended March 31, 2016, the Company reduced research and development expenses by $3.7 million and general and administrative expenses by $0.1 million, representing Mylan’s 50% share of collaboration expenses.

6. Share-Based Payments

Share-Based Compensation

The following table summarizes share-based compensation expense (income) recorded in the three months ended March 31, 2016 and 2015 (in thousands):

Share-based compensation expense (income)	For the Three Months Ended March 31, 2016		For the Three Months Ended March 31, 2015
Outstanding employee and non-employee stock option grants	$	2,758	$	2,370
Outstanding restricted stock awards	1,958		(6,850		)
Employee stock purchase plan	112		95
Total compensation expense (income)	$	4,828	$	(4,385	)

During the three months ended March 31, 2016, the Company granted 975,152 stock options, of which 774,302 were granted in connection with annual merit awards, 140,850 were granted to new hires and 60,000 were granted to members of our board of directors. The average grant date fair value of options granted was calculated using the Black-Scholes-Merton option-pricing model and the weighted average assumptions are noted in the table below. The weighted average grant date fair value of option awards granted during the three months ended March 31, 2016 and 2015 was $5.81 per option and $7.49 per option, respectively.

The following table summarizes the weighted average assumptions the Company used in its fair value calculations at the date of grant:

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	Weighted Average Assumptions
	Stock Options				Employee Stock Purchase Plan
	For the Three Months Ended March 31, 2016		For the Three Months Ended March 31, 2015		For the Three Months Ended March 31, 2016		For the Three Months Ended March 31, 2015
Expected volatility	57	%	61	%	56	%	61	%
Expected dividends	—		—		—		—
Expected life (years)	6.1		6.2		0.5		0.5
Risk-free interest rate	1.6	%	1.8	%	0.4	%	0.1	%

At March 31, 2016, the total remaining unrecognized compensation cost related to nonvested stock option awards amounted to $18.3 million, net of estimated forfeitures, which will be recognized over the weighted average remaining requisite service period of 2.68 years.

During the three months ended March 31, 2016, the Company issued 52,116 shares of common stock to employees under the employee stock purchase plan, or ESPP, resulting in proceeds of approximately $0.6 million.

Restricted Stock Awards

The Company has also made awards of time-based and performance-based restricted common stock to its employees and officers. In the three months ended March 31, 2016, the Company awarded 387,321 shares of time-based restricted common stock to its employees and officers in connection with its annual merit grant. The time-based restricted common stock vest as to 25% on the one year anniversary of the grant date and as to 6.25% quarterly over three years that follow the grant date. The time-based awards are generally forfeited if the employment relationship terminates with the Company prior to vesting.

Between 2011 and early 2013, the Company awarded 949,620 shares of performance-based restricted common stock to its employees and officers. The performance-based restricted common stock was scheduled to vest upon FDA approval of the GLATOPA Abbreviated New Drug Application, or ANDA, on or before the performance deadline date of March 28, 2015 according to the following schedule: 50% of the shares vest upon FDA approval and 50% vest upon the one-year anniversary of FDA approval. The Company had historically determined that the performance condition was probable of being achieved by March 28, 2015 and, as a result, had recognized approximately $10.5 million of stock compensation costs related to the awards. On March 11, 2015, the Board of Directors approved an amendment to the awards that extended the performance deadline date to September 1, 2015 and provided for the forfeiture of 15% of the number of shares originally subject to each award on the 29th of each month, beginning March 29, 2015 until the shares vested or were forfeited in full. On March 29, 2015, 117,898 shares of performance-based restricted common stock were forfeited pursuant to the modified awards. The Company evaluated the modification and determined it was a Type III modification or “Improbable to Probable” pursuant to ASC 718 as the awards, on the date of modification, were no longer deemed to be probable of being earned by March 28, 2015. As a result, the Company reversed the cumulative compensation cost related to the original awards of $10.5 million in the first quarter of 2015. Also, in accordance with ASC 718, the Company re-measured the modified awards with a measurement date of March 11, 2015, and determined the aggregate compensation was $9.8 million. The FDA approved GLATOPA on April 16, 2015. The Company is recognizing the compensation cost attributed to the modified awards as follows: the first 50% of the awards was expensed over the period beginning on March 11, 2015 and ending on April 16, 2015, the date of FDA approval, and the remaining 50% of the awards expected to vest will be expensed over the period beginning on March 11, 2015 and ending on April 16, 2016, the one year anniversary of FDA approval. Accordingly, approximately $9.1 million of stock compensation cost was recognized in the period between March 11, 2015 and March 31, 2016. As of March 31, 2016, the total remaining unrecognized compensation cost related to the nonvested portion of the modified awards amounted to $0.2 million, which will be recognized in the second quarter of 2016 as the performance condition was achieved in April 2016.

As of March 31, 2016, the total remaining unrecognized compensation cost related to all nonvested time-based and performance-based restricted stock awards amounted to $8.8 million, which is expected to be recognized over the weighted average remaining requisite service period of 2.23 years.

A summary of the status of nonvested shares of restricted stock as of March 31, 2016 and the changes during the three months then ended are presented below (in thousands, except fair values):

	Number of Shares		Weighted Average Grant Date Fair Value
Nonvested at January 1, 2016	761		$	14.61
Granted	387		10.83
Vested	(104	)	14.11
Forfeited	(22	)	14.07

Nonvested at March 31, 2016	1,022		$	13.24

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Nonvested shares of restricted stock that have time-based or both performance-based and time-based vesting conditions as of March 31, 2016 are summarized below (in thousands):

Vesting Schedule		Nonvested Shares
Time-based		714
Performance-based and time-based		308

Nonvested at March 31, 2016		1,022

7. Equity Financings

In May 2014, the Company entered into an At-the-Market Equity Offering Sales Agreement, or the 2014 ATM Agreement, with Stifel, Nicolaus & Company, Incorporated, or Stifel, under which the Company was authorized to issue and sell shares of its common stock having aggregate sales proceeds of up to $75 million from time to time through Stifel, acting as sales agent and/or principal. The Company paid Stifel a commission of 2.0% of the gross proceeds from the sale of shares of its common stock under this facility. The offering was conducted by the Company pursuant to an effective shelf registration statement previously filed with the Securities and Exchange Commission (Reg. No. 333-188227) and a related prospectus supplement. The Company intends to use the net proceeds from this facility to advance its development pipeline and for general corporate purposes, including working capital. In the three months ended March 31, 2015, the Company sold approximately 2.6 million shares of common stock under the 2014 ATM Agreement, raising aggregate net proceeds of approximately $33.7 million. The Company concluded sales under the 2014 ATM Agreement in April 2015. Between October 2014 and April 2015, the Company sold approximately 5.4 million shares of common stock under the 2014 ATM Agreement, raising aggregate net proceeds of approximately $73.5 million.

In April 2015, the Company entered into a new ATM Agreement, or the 2015 ATM Agreement, with Stifel, under which the Company is authorized to issue and sell shares of its common stock having aggregate sales proceeds of up to $75 million from time to time through Stifel, acting as sales agent and/or principal. The Company is required to pay Stifel a commission of 2.0% of the gross proceeds from the sale of shares of its common stock under the 2015 ATM Agreement. Sales of common stock under this facility have been made pursuant to an effective shelf registration statement previously filed with the Securities and Exchange Commission (Reg. No. 333-188227) and a related prospectus supplement. Between April 2015 and December 2015, the Company sold approximately 0.5 million shares of common stock under the 2015 ATM Agreement, raising aggregate net proceeds of approximately $9.3 million. No shares were sold under the 2015 ATM Agreement in the three months ended March 31, 2016.

8. Commitments and Contingencies

The disclosures relating to the Company’s operating lease obligations are included in its Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission on February 26, 2016.

Legal Contingencies

The Company is involved in various litigation matters that arise from time to time in the ordinary course of business. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters will adversely affect the Company, its results of operations, financial condition and cash flows. The Company’s general practice is to expense legal fees as services are rendered in connection with legal matters, and to accrue for liabilities when losses are probable and reasonably estimable. The Company evaluates, on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of any accrual on its consolidated balance sheets.

M356-Related Litigation

On September 10, 2014, Teva Pharmaceuticals Industries Ltd. and related entities, or Teva, and Yeda Research and Development Co., Ltd., or Yeda, filed suit against the Company and Sandoz Inc. in the United States Federal District Court in the District of Delaware in response to the filing by Sandoz Inc. of the ANDA with a Paragraph IV certification for M356. The suit initially alleged infringement related to two Orange Book-listed patents for COPAXONE 40 mg/mL, each expiring in 2030, and seeks declaratory and injunctive relief prohibiting the launch of the Company’s product until the last to expire of these patents. In April 2015, Teva and Yeda filed an additional suit against the Company and Sandoz Inc. in the United States District Court for the District of Delaware alleging infringement related to a third Orange Book-listed patent for COPAXONE 40 mg/mL, which issued in March 2015 and expires in 2030. In May 2015, this suit was consolidated with the initial suit filed in September 2014. In November 2015, Teva and Yeda filed a suit against the Company and Sandoz Inc. in the United States

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District Court for the District of Delaware alleging infringement related to a fourth Orange Book-listed patent for COPAXONE 40 mg/mL, which issued in October 2015 and expires in 2030. Teva and Yeda seek declaratory and injunctive relief prohibiting the launch of M356 until the expiration of this patent. In December 2015, this suit was consolidated with the initial suit filed in September 2014. The Company and Sandoz Inc. have asserted various defenses and filed counterclaims for declaratory judgments of non-infringement, invalidity and unenforceability of the COPAXONE 40 mg/mL patents. A pre-trial claim construction hearing was held in February 2016 and the trial is scheduled to begin in September 2016.

Enoxaparin Sodium Injection-related Litigation

On September 21, 2011, the Company and Sandoz Inc. sued Amphastar and Actavis, in the United States District Court for the District of Massachusetts for infringement of two of the Company’s patents. Also in September, 2011, the Company filed a request for a temporary restraining order and preliminary injunction to prevent Amphastar and Actavis from selling their enoxaparin product in the United States. In October 2011, the District Court granted the Company’s motion for a preliminary injunction and entered an order enjoining Amphastar and Actavis from advertising, offering for sale or selling their enoxaparin product in the United States until the conclusion of a trial on the merits and required the Company and Sandoz Inc. to post a security bond of $100 million in connection with the litigation. Amphastar and Actavis appealed the decision to the Court of Appeals for the Federal Circuit, or CAFC, and in January 2012, the CAFC stayed the preliminary injunction. In August 2012, the CAFC vacated the preliminary injunction and remanded the case to the District Court. In September 2012, the Company filed a petition with the CAFC for a rehearing by the full court en banc, which was denied. In February 2013, the Company filed a petition for a writ of certiorari for review of the CAFC decision by the United States Supreme Court and in June 2013 the Supreme Court denied the petition.

In July 2013, the District Court granted a motion by Amphastar and Actavis for summary judgment. The Company filed a notice of appeal of that decision to the CAFC. In February 2014, Amphastar filed a motion to the CAFC for summary affirmance of the District Court ruling, which the CAFC denied in May 2014. On November 10, 2015, the CAFC affirmed the District Court summary judgment decision with respect to Actavis, reversed the District Court summary judgment decision with respect to Amphastar, and remanded the case against Amphastar to the District Court. On January 11, 2016, Amphastar filed a petition for rehearing by the CAFC, which was denied on February 17, 2016. The collateral for the security bond posted in the litigation remains outstanding. In the event that the Company is not successful in further prosecution or settlement of this action against Amphastar, and Amphastar is able to prove they suffered damages as a result of the preliminary injunction, the Company could be liable for damages for up to $35 million of the security bond. Amphastar has filed motions to increase the amount of the security bond, which the Company and Sandoz Inc. have opposed.

On September 17, 2015, Amphastar filed a complaint against the Company and Sandoz Inc. in the United States District Court for the Central District of California. The complaint alleges that, in connection with filing the September 2011 patent infringement suit against Amphastar and Actavis, the Company and Sandoz Inc. sought to prevent Amphastar from selling generic enoxaparin sodium injection and thereby exclude competition for generic enoxaparin sodium injection in violation of federal and California anti-trust laws and California unfair business laws. Amphastar is seeking unspecified damages and fees. In December 2015, the Company and Sandoz Inc. filed a motion to dismiss and a motion to transfer the case. In January 2016, the case was transferred to the United States District Court for the District of Massachusetts. In February 2016, Amphastar filed a writ of mandamus with the United States Court of Appeals for the Ninth Circuit requesting the court to reverse and review the District Court’s grant of transfer. While the outcome of litigation is inherently uncertain, the Company believes this suit is without merit, and the Company intends to vigorously defend itself in this litigation.

On October 14, 2015, The Hospital Authority of Metropolitan Government of Nashville and Davidson County, Tennessee, d/b/a Nashville General Hospital, or NGH, filed a class action suit against the Company and Sandoz Inc. in the United States District Court for the Middle District of Tennessee on behalf of certain purchasers of LOVENOX or generic enoxaparin sodium injection. The complaint alleges that, in connection with filing the September 2011 patent infringement suit against Amphastar and Actavis, the Company and Sandoz Inc. sought to prevent Amphastar from selling generic enoxaparin sodium injection and thereby exclude competition for generic enoxaparin sodium injection in violation of federal anti-trust laws. NGH is seeking injunctive relief, disgorgement of profits and unspecified damages and fees. In December 2015, the Company and Sandoz Inc. filed a motion to dismiss and a motion to transfer the case to the United States District Court for the District of Massachusetts. Hearings on the motions were held in February 2016 on the motion to transfer and in April 2016 on the motion to dismiss, before a United States magistrate. These motions are pending before the magistrate and subject to review by the court. While the outcome of litigation is inherently uncertain, the Company believes this suit is without merit, and it intends to vigorously defend itself in this litigation.

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Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2015.

This discussion contains forward-looking statements that involve significant risks and uncertainties. As a result of many important factors, such as those set forth under “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements.

Overview

We are a biotechnology company focused on developing generic versions of complex drugs, biosimilars and novel therapeutics for oncology and autoimmune disease.

To date, we have devoted substantially all of our capital resource expenditures to the research and development of our product candidates. Although we were profitable in fiscal years 2010 and 2011, since that time we have been incurring operating losses, and we expect to incur annual operating losses over the next several years as we advance our drug development portfolio. As of March 31, 2016, we had an accumulated deficit of approximately $476 million. We will need to generate significant revenue to return to profitability. We expect that our return to profitability, if at all, will most likely come from the commercialization of the products in our drug development portfolio.

Complex Generics

GLATOPA®—Generic COPAXONE® (glatiramer acetate injection) 20 mg/mL

On April 16, 2015, the FDA approved the ANDA for once-daily GLATOPA (glatiramer acetate injection) 20 mg/mL, a generic equivalent of once-daily COPAXONE® 20 mg/mL. GLATOPA is the first “AP” rated, substitutable generic equivalent of once-daily COPAXONE. Sandoz commenced sales of GLATOPA on June 18, 2015. Under our collaboration agreement with Sandoz AG, we earn 50% of contractually-defined profits on GLATOPA sales. For the three months ended March 31, 2016, we recorded $14.8 million in product revenues from Sandoz’ sales of GLATOPA.

GLATOPA was formerly referred to as M356. M356 now refers to our generic product candidate for three-times-weekly COPAXONE 40 mg/mL.

M356—Generic Three-times-weekly COPAXONE® (glatiramer acetate injection) 40 mg/mL

An ANDA with a Paragraph IV certification for our generic version of three-times-weekly COPAXONE 40 mg/mL, which was filed in February 2014, remains under review by the FDA. Our M356 formulation contains the same drug substance as GLATOPA, which we believe should help streamline the FDA review of the ANDA. To date, we are the only ANDA applicant for the three-times-weekly COPAXONE 40 mg/mL with an approved active pharmaceutical ingredient. If we are successful in our challenge of the patents related to 40 mg/mL COPAXONE, and based on the scheduled September 2016 trial start date and assuming customary patent litigation timelines, we believe M356 could be approved, following expiration regulatory exclusivity and of any 30-month stay, if applicable, and be on the market as early as the first quarter of 2017. In August 2015, the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office, or PTAB, instituted an Inter Partes Review, or IPR, filed by a third party challenging the validity of several of the same patents relating to 40 mg/mL COPAXONE that are the subject of our patent litigation. Although the IPR decision, which is expected in August 2016, is not binding on the court, we believe the outcome of this IPR could indirectly impact our M356 litigation and launch timelines.

Enoxaparin Sodium Injection—Generic LOVENOX®

In June 2015, we and Sandoz amended our collaboration agreement relating to Enoxaparin Sodium Injection, replacing Sandoz’ obligation to pay us a royalty on net sales with an obligation to pay us 50% of contractually-defined profits on sales. The amendment, which was effective April 1, 2015, better aligned our interests in an evolving market that has seen continued pricing pressure.

Sandoz did not record any profit on sales of Enoxaparin Sodium Injection in the three months ended March 31, 2016, and therefore we recorded no revenue for Enoxaparin Sodium Injection in the period.

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Biosimilars

M923—Biosimilar HUMIRA® (adalimumab) Candidate

In connection with Baxter’s internal corporate restructuring in July 2015, Baxter assigned all of its rights and obligations under the Baxter Collaboration Agreement to Baxalta. In light of the assignment, all references to Baxter and the Baxter Collaboration Agreement have been replaced with references to Baxalta and the Baxalta Collaboration Agreement, respectively. In January 2016, Baxalta and Shire plc announced an agreement under which Shire will combine with Baxalta, subject to shareholder and regulatory approvals.

In February 2015, Baxalta commenced a randomized, double-blind, single-dose study in healthy volunteers to compare the pharmacokinetics, safety, tolerability and immunogenicity of M923 versus EU-sourced and US-sourced HUMIRA. A total of 324 healthy volunteers were enrolled in the study. The volunteers were randomized 1:1:1 to receive a single 40 mg injection of M923, US-sourced HUMIRA, or EU-sourced HUMIRA. The volunteers were followed for 71 days. In December 2015, we announced that M923 met its primary endpoint in the study as the data demonstrated pharmacokinetic bioequivalence to the reference products. In October 2015, Baxalta initiated a pivotal clinical trial of M923 in patients with chronic plaque psoriasis. The trial is a randomized, double-blind, active control, multi-center, global study in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with HUMIRA. In April 2016, we and Baxalta completed enrollment in the pivotal clinical trial for M923, and we expect to report data from this trial in the second half of 2016 or early 2017. Baxalta is planning to submit the first regulatory submission for marketing approval for M923 in 2017 and, subject to marketing approval and patent considerations, we expect first commercial launch to be as early as 2018.

M834—Biosimilar ORENCIA® (abatacept) Candidate

On January 8, 2016, we and Mylan entered into the Mylan Collaboration Agreement, which became effective on February 9, 2016, pursuant to which we and Mylan agreed to collaborate exclusively, on a world-wide basis, to develop, manufacture and commercialize six of our biosimilar candidates, including M834. Under the terms of the Mylan Collaboration Agreement, Mylan paid us a non-refundable upfront payment of $45 million in March 2016. In addition, we and Mylan will share equally costs, including development, manufacturing, commercialization and certain legal expenses, and profits (losses) across the six product candidates. We are in the final stages of preclinical and process development work and plan to initiate a clinical trial of M834 in the second half of 2016. We believe there is currently limited biosimilar competition for M834. Subject to development, marketing approval and patent considerations, we expect to be able to launch M834 in the 2020 timeframe to be able to be among the first biosimilars on the market for ORENCIA.

Other Biosimilar Candidates

Under our Mylan collaboration, we and Mylan are also developing five other biosimilar candidates from our portfolio, in addition to M834. We and Mylan will share equally costs and profits (losses) related to these earlier stage product candidates. We and Mylan will share development responsibilities across product candidates, and Mylan will lead commercialization of the products.

As of March 31, 2016, we had over 100 employees working on our biosimilars programs. We maintain a state-of-the-art development facility for bioprocess manufacturing development and scale-up.

Novel Therapeutics

Necuparanib

In 2012, we initiated a Phase 1/2 clinical trial evaluating necuparanib in combination with ABRAXANE® (nab-paclitaxel) plus gemcitabine in patients with advanced metastatic pancreatic cancer. In October 2014, we successfully completed and reported top-line data from Part A, or Phase 1, of the trial, including determining a maximum tolerated dose of 5 mg/kg. In June 2015 at the American Society of Clinical Oncology, or ASCO, annual meeting, we reported more mature data from Phase 1, which continued to show acceptable safety and tolerability and encouraging signals of activity, including the following:

· Adding necuparanib to ABRAXANE and gemcitabine did not appear to increase the toxicity profile associated with ABRAXANE and gemcitabine alone.

· Of the 24 patients who received at least one dose of necuparanib in combination with ABRAXANE plus gemcitabine, the median overall survival was 14.2 months. Also, within a subset of 16 patients who completed one cycle and had at least one scan on treatment, the median overall survival was 15.3 months.

· Of the 15 patients treated with necuparanib in combination with ABRAXANE plus gemcitabine that completed Cycle 1 and had at least one follow-up measurement for CA19.9 (a biomarker predictive of long-term outcome and treatment response in pancreatic cancer), 93% had a greater than 50% decrease from baseline, and 100% had a greater than 20% decrease from baseline.

We believe the safety data and early signals of activity are encouraging and that the 5 mg/kg dose has the potential to provide significantly higher levels of activity against multiple cancer targets than traditional anticoagulant heparins have achieved. We believe these results, combined with nonclinical data in other cancer models, and necuparanib’s differentiated, multi-targeted mechanism of action, suggest the possibility of combining necuparanib with other chemotherapy and targeted therapy standards of care in a variety of other tumor types. We continue to collect data from Phase 1 of the trial and plan to present final results at ASCO in June 2016.

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We continue to enroll patients in Part B, or Phase 2, of the trial, to evaluate the antitumor activity of necuparanib in combination with ABRAXANE plus gemcitabine, versus ABRAXANE plus gemcitabine alone. We expect data from this randomized trial to be available in the second half of 2017. Subject to successfully completing clinical trials and obtaining marketing approval, we believe necuparanib could be on the market in the 2020-2021 timeframe, or potentially earlier under Fast-Track Designation.

In June 2014, necuparanib received Orphan Drug Designation from the U.S. FDA for the treatment of pancreatic cancer. In December 2014, we received Fast-Track Designation by the FDA for necuparanib as a first-line treatment in combination with ABRAXANE and gemcitabine in patients with metastatic pancreatic cancer.

Other Novel Therapeutic Programs

We are continuing to advance M281, our Anti-FcRn program, and M230, our SIF3 program. We have received regulatory clearance for M281 and plan to initiate a Phase 1 dosing study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of M281 in healthy volunteers in the second quarter of 2016. We expect to initiate a clinical trial for M230 in 2017. We are currently identifying and pursuing potential collaboration opportunities to further develop and commercialize our hsIVIg program.

We believe these early stage programs could have the potential to produce product candidates capable of treating a large number of immunological disorders driven by antibodies, immune complexes, and Fc receptor biology. Such disorders include rheumatoid arthritis, autoimmune neurologic diseases such as Guillain-Barre syndrome, chronic inflammatory demyelinating neuropathy and myasthenia gravis, autoimmune blood disorders such as immune thrombocytopenic purpura, systemic autoimmune diseases such as dermatomyositis, lupus nephritis, and catastrophic antiphospholipid syndrome, antibody-mediated transplant rejection, and autoimmune blistering diseases, several of which have few treatment options.

Equity Financings

In May 2014, we entered into an At-the-Market Equity Offering Sales Agreement, or the 2014 ATM Agreement, with Stifel, Nicolaus & Company, Incorporated, or Stifel, under which we were authorized to issue and sell shares of our common stock having aggregate sales proceeds of up to $75 million from time to time through Stifel, acting as sales agent and/or principal. We paid Stifel a commission of 2.0% of the gross proceeds from the sale of shares of our common stock under this facility. The offering was conducted by us pursuant to an effective shelf registration statement previously filed with the Securities and Exchange Commission (Reg. No. 333-188227) and a related prospectus supplement. We intend to use the net proceeds from this facility to advance our development pipeline and for general corporate purposes, including working capital. In the three months ended March 31, 2015, we sold approximately 2.6 million shares of common stock under the 2014 ATM Agreement, raising aggregate net proceeds of approximately $33.7 million. We concluded sales under the 2014 ATM Agreement in April 2015.

In April 2015, we entered into a new ATM Agreement, or the 2015 ATM Agreement, with Stifel, under which we are authorized to issue and sell shares of our common stock having aggregate sales proceeds of up to $75 million from time to time through Stifel, acting as sales agent and/or principal. We are required to pay Stifel a commission of 2.0% of the gross proceeds from the sale of shares of our common stock under the 2015 ATM Agreement. Sales of common stock under this facility are made pursuant to an effective shelf registration statement previously filed with the Securities and Exchange Commission (Reg. No. 333-188227) and a related prospectus supplement. From April 2015 through December 2015, we sold approximately 0.5 million shares of common stock under the 2015 ATM Agreement, raising aggregate net proceeds of approximately $9.3 million. We did not sell any shares of common stock under the 2015 ATM Agreement in the three months ended March 31, 2016.

Results of Operations

Comparison of Three Months Ended March 31, 2016 and 2015

Collaboration Revenue

Collaboration revenue includes both product revenue and research and development revenue earned under our collaborative arrangements. Product revenue includes our contractually-defined profits and/or royalties earned on Sandoz’ sales of Enoxaparin Sodium Injection and GLATOPA.

GLATOPA®—Generic COPAXONE® (glatiramer acetate injection) 20 mg/mL

Sandoz commenced sales of GLATOPA in the United States on June 18, 2015. We earn 50% of contractually-defined profits on Sandoz’ sales of GLATOPA. A portion of certain GLATOPA legal expenses, including any patent infringement damages, is deducted from our profits in proportion to our 50% profit sharing interest.

For the three months ended March 31, 2016, we recorded $14.8 million in product revenues from Sandoz’ sales of GLATOPA. We estimate that the number of prescriptions for GLATOPA represents nearly 35% of the once-daily 20 mg/mL U.S. glatiramer acetate market.

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We believe there is a meaningful market opportunity for GLATOPA. The price for COPAXONE 20 mg/mL has increased over 165% since 2009 and there is no other generic for multiple sclerosis currently available in the United States. However, Teva received marketing approval of its three-times-weekly COPAXONE 40 mg/mL in January 2014. Teva’s three-times-weekly COPAXONE 40 mg/mL accounts for more than 70% of the overall U.S. glatiramer acetate market (20 mg/mL and 40mg/mL). Because GLATOPA is only a substitutable generic version of the 20 mg/mL formulation of COPAXONE, the market potential of GLATOPA is negatively impacted by the conversion of patients from once-daily COPAXONE to three-times-weekly COPAXONE. Teva reported $4.0 billion in worldwide sales of COPAXONE (20 mg/mL and 40 mg/mL) in 2015, $3.2 billion of which was from the United States.

Enoxaparin Sodium Injection—Generic LOVENOX®

Effective April 1, 2015, we began to earn 50% of contractually-defined profits on Sandoz’ sales of Enoxaparin Sodium Injection.

Sandoz did not record any profit on sales of Enoxaparin Sodium Injection in the three months ended March 31, 2016, and therefore we recorded no revenue for Enoxaparin Sodium Injection in the period. For the three months ended March 31, 2015, we earned $2.7 million in royalties on Sandoz’s reported net sales of Enoxaparin Sodium Injection of $25.9 million. The decrease in our product revenue was $2.7 million, or 100%, from the 2015 period to the 2016 period and was attributed to the change in our collaboration economics and lower unit sales driven by lower market share and lower prices in response to competitor pricing reductions on enoxaparin.

Due to increased generic competition and resulting decreased market pricing for generic enoxaparin sodium injection products, we do not anticipate significant Enoxaparin Sodium Injection product revenue in the near future.

Research and Development Revenue

Research and development revenue generally consists of amounts earned by us under our collaborations for:

· Technical development, regulatory and commercial milestones under the Sandoz and Baxalta collaborations;

· Reimbursement of research and development services and reimbursement of development costs under our Sandoz and Baxalta collaborations; and

· Recognition of the arrangement consideration under our Baxalta and Mylan collaborations.

Research and development revenue was $5.1 million and $5.8 million for the three months ended March 31, 2016 and 2015, respectively. The decrease in research and development revenue of $0.7 million, or 12%, from the 2015 period to the 2016 period is due to lower reimbursable FTEs and external costs for M923 as Baxalta has clinical development responsibilities for that program by $1.6 million, partially offset by recognition of arrangement consideration of $0.9 million under our collaboration with Mylan.

We expect collaborative research and development revenue earned by us related to FTE and external expense reimbursement from Baxalta and Sandoz will fluctuate from quarter to quarter in 2016 depending on our research and development activities. We expect to recognize the arrangement consideration under our collaborations with Baxalta and Mylan ratably as revenue over our performance period with 2016 quarterly revenue amounts of approximately $2.4 million and $1.8 million, respectively.

Research and Development Expense

Research and development expenses consist of costs incurred to conduct research, such as the discovery and development of our product candidates. We recognize all research and development costs as they are incurred. We track the external research and development costs incurred for each of our product candidates. Our external research and development expenses consist primarily of:

· expenses incurred under agreements with consultants, third-party contract research organizations, or CROs, and investigative sites where all of our nonclinical studies and clinical trials are conducted;

· costs of acquiring reference comparator materials and manufacturing nonclinical study and clinical trial supplies and other materials from contract manufacturing organizations, or CMOs, and related costs associated with release and stability testing; and

· costs associated with process development activities.

Internal research and development costs are associated with activities performed by our research and development organization and consist primarily of:

· personnel-related expenses, which include salaries, benefits and share-based compensation; and

· facilities and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation and amortization of leasehold improvements and equipment and laboratory and other supplies.

Beginning on February 9, 2016, under the Mylan Collaboration Agreement, we share collaboration expenses with Mylan. A portion of the net amount due from Mylan for its 50% share of collaboration expenses is recorded as a reduction in research and development expenses based on the nature of the cost reimbursement. Collaboration costs for development of the six biosimilar candidates under the collaboration incurred by us are recorded as research and development expense as incurred.

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Research and development expense for the three months ended March 31, 2016 was $28.8 million, compared with $22.7 million for the three months ended March 31, 2015. The increase of $6.1 million, or 27%, from the 2015 period to the 2016 period primarily resulted from increases of: $5.0 million in personnel-related expenses, primarily attributed to the reversal of prior period share-based compensation expense in the first quarter of 2015 associated with performance-based stock awards; $3.3 million in third-party research and process development costs primarily attributable to advance our biosimilar and novel therapeutic programs; $0.6 million in allocated expenses for rent and maintenance of facilities, depreciation and amortization of leasehold improvements and equipment; $0.6 million in clinical trial expenses as the necuparanib Phase 2 clinical trial continued to accrue patients; and $0.3 million in professional fees, driven mainly by temporary labor and regulatory filing fees. These increases were partially offset by a decrease of $3.7 million for Mylan’s 50% share of collaboration costs under our cost-sharing collaboration agreement. In March 2015, we amended performance stock awards related to the GLATOPA ANDA approval to reduce the number of shares subject to the awards and to extend the performance period. Upon the amendment, stock compensation previously recognized was reversed and new stock compensation was recognized ratably based on the GLATOPA ANDA approval, which occurred in April 2015. In the first quarter of 2015 research and development expense included a stock compensation credit of $5.1 million and expense of $1.5 million relating to these performance grants. In the first quarter of 2016 research and development expense relating to the performance grants was $0.5 million.

The lengthy process of securing FDA approval for generics and new drugs requires the expenditure of substantial resources. Any failure by us to obtain, or any delay in obtaining, regulatory approvals would materially adversely affect our product development efforts and our business overall. Accordingly, we cannot currently estimate with any degree of certainty the amount of time or money that we will be required to expend in the future on our product candidates prior to their regulatory approval, if such approval is ever granted. As a result of these uncertainties surrounding the timing and outcome of any approvals, we are currently unable to estimate when, if ever, our product candidates will generate revenues and cash flows.

The following table sets forth the primary components of our research and development external expenditures, including the amortization of our intangible asset, for each of our principal development programs for the three months ended March 31, 2016 and 2015. The figures in the table include project expenditures incurred by us and reimbursed by our collaborators, but exclude project expenditures incurred by our collaborators. Although we track and accumulate personnel effort by percentage of time spent on our programs, a significant portion of our internal research and development costs, including salaries and benefits, share-based compensation, facilities, depreciation and laboratory supplies are not directly charged to programs. Therefore, our methods for accounting for internal research and development costs preclude us from reporting these costs on a project-by-project basis.

	Phase of Development as of	Three Months Ended March 31,				Project Inception to
	March 31, 2016	2016		2015		March 31, 2016
External Costs Incurred by Product Candidate:
GLATOPA and M356—Generic COPAXONE® (20 mg/mL and 40 mg/mL)	ANDAs filed(1)	$	293	$	147	$	49,156
Necuparanib—Oncology Product Candidate	Phase 2	3,056		2,100		39,931
Biosimilars	Various(2)(3)	4,450		3,896		81,633
Other novel therapeutic programs	Discovery/Nonclinical	2,599		2,147
Internal Costs		18,359		14,459
Total Research and Development Expenses(3)		$	28,757	$	22,749

(1) On April 16, 2015, the FDA approved the ANDA for once-daily Glatopa. Sandoz launched Glatopa on June 18, 2015. The ANDA for M356 is under FDA review.

(2) Biosimilars include M923, a biosimilar candidate of HUMIRA® (adalimumab), M834, a biosimilar candidate of ORENCIA® (abatacept), as well as seven other biosimilar candidates. Enrollment in a Baxalta-initiated pivotal clinical trial of M923 in patients with chronic plaque psoriasis is complete. We are in the final stages of preclinical and process development work and plan to initiate a clinical trial of M834 in the second half of 2016. We expect to initiate a Phase 1 dosing study for M281 in the second quarter of 2016. Our other biosimilar candidates are in discovery and process development.

(3) As a result of the cost-sharing provisions of the Mylan Collaboration Agreement, we offset approximately $3.7 million against research and development costs during the three months ended March 31, 2016.

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The increase in our necuparanib external expenditures of $1.0 million, or 46%, from the 2015 period to the 2016 period as we accrue more clinical sites and patients in our Phase 2 clinical trial. Our process development and contract research costs for the programs being developed under our collaboration with Mylan increased by $0.9 million from the 2015 period to the 2016 period. Our external expenditures for M923, in collaboration with Baxalta, decreased by $0.3 million from the 2015 period to the 2016 period as Baxalta has clinical development responsibility for that program. The increase of $0.5 million, 21%, in other novel therapeutics program external expenditures from the 2015 period to the 2016 period was due to increased nonclinical and process development to advance M281 and M230.

Our total operating expenses will be increasing in 2016 due to increased development costs in both our biosimilar and novel therapeutic development programs. The necuparanib Phase 2 study is accruing patients, and our two preclinical programs, M281 and M230, are advancing toward the clinic, with M281 targeted to enter the clinic in the second quarter of 2016 and M230 in 2017. Under the Mylan Collaboration Agreement, we have the operating responsibility for M834 through clinical development, which we expect to initiate in the second half of 2016.

Due to the variability in the length of time necessary to develop a product, the uncertainties related to the estimated cost of the projects and ultimate ability to obtain governmental approval for commercialization, accurate and meaningful estimates of the ultimate cost to bring our product candidates to market are not available.

General and Administrative Expense

General and administrative expenses consist primarily of salaries and other related costs for personnel in general and administrative functions, professional fees for legal and accounting services, royalty and license fees, insurance costs, and allocated rent, facility and lab supplies, and depreciation expense.

Beginning on February 9, 2016, under our collaboration agreement with Mylan we share collaboration expenses. A portion of the net amount due from Mylan for its 50% share of collaboration expenses under the cost-sharing arrangement is recorded as a reduction in general and administrative expenses based on the nature of the cost reimbursement. Collaboration costs for certain legal expenses for the six biosimilar candidates under the collaboration incurred by us are recorded as general and administrative expense as incurred.

General and administrative expense for the three months ended March 31, 2016 was $15.6 million, compared with $7.9 million for the three months ended March 31, 2015. The increase of $7.7 million, or 97%, from the 2015 period to the 2016 period was due to increases of: $6.3 million in personnel-related expenses primarily due to the reversal of prior period share-based compensation expense in the first quarter of 2015 associated with performance-based stock awards discussed under “Research and Development Expense” and $1.4 million in professional fees, driven mainly by increased legal and consulting fees. In the first quarter of 2015 general and administrative expense included a stock compensation credit of $5.4 million and expense of $1.5 million relating to the performance grants.

We expect our general and administrative expenses, including internal and external legal and business development costs that support our various product development efforts, to vary from period to period in relation to our commercial and development activities.

Interest Income

Interest income was $0.5 million and $0.1 million for the three months ended March 31, 2016 and 2015, respectively. The increase of $0.4 million from the 2015 period to the 2016 period was caused by higher average investment balances due to 2015 fundraising activities.

Other Income

Other income was $0.1 million for each of the three months ended March 31, 2016 and 2015 and represents other income related to a job creation tax award that was granted to us in the fourth quarter of 2012.

Liquidity and Capital Resources

At March 31, 2016, we had $362.8 million in cash, cash equivalents and marketable securities and $21.7 million in collaboration receivable, including $14.8 million for our profit share from GLATOPA sales in the first quarter of 2016. In addition, we also held $20.7 million in restricted cash, of which $17.5 million serves as collateral for a security bond posted in the litigation against Amphastar. Our funds at March 31, 2016 were primarily invested in senior debt of government-sponsored enterprises, commercial paper, overnight repurchase agreements, asset-backed securities, corporate debt securities and United States money market funds, directly or through managed funds, with remaining maturities of 24 months or less. Our cash is deposited in and invested through highly rated financial institutions in North America. The composition and mix of cash, cash equivalents and marketable securities may change frequently as a result of our evaluation of conditions in the financial markets, the maturity of specific investments, and our near term liquidity needs. We do not believe that our cash equivalents and marketable securities were subject to significant market risk at March 31, 2016.

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We have funded our operations primarily through the sale of equity securities and payments received under our collaboration and license agreements, including product revenue from Sandoz’ sales of Enoxaparin Sodium Injection and GLATOPA. Since our inception through March 31, 2016, we have received $638 million through private and public issuances of equity securities, including approximately $148 million in net proceeds from our May 2015 public offering of common stock and approximately $83 million under our At-the-Market Equity Offering Sales Agreements, or the ATM Agreements, with Stifel, Nicolaus & Company, Incorporated entered into in May 2014 and April 2015, respectively. As of March 31, 2016, we had received a cumulative total of $677 million under our collaborations with Sandoz, including $469 million in revenues on sales of Enoxaparin Sodium Injection and regulatory and commercial milestones related to that product and $78 million in revenues on sales of GLATOPA and regulatory and commercial milestones related to that product. In addition, we received $84 million under our collaboration with Baxalta, including a $33 million upfront payment, $32 million in reimbursement of research and development services and costs and $19 million in license and milestone payments. In March 2016, we received a $45 million upfront payment from Mylan under the Mylan Collaboration Agreement. We expect to receive $60 million of the total $200 million in contingent milestone payments from Mylan in 2016.

We expect to finance and manage our planned operating and expenditure requirements principally through our current cash, cash equivalents and marketable securities; capital raised through equity financings, including under our ATM Agreements; and future product revenues. We believe that these funds will be sufficient to meet our operating requirements through at least the end of 2018.

	Three Months Ended March 31,
	2016		2015
	(in thousands)
Net cash provided by (used in) operating activities	$	13,923	$	(28,576	)
Net cash provided by investing activities	$	13,489	$	28,259
Net cash provided by financing activities	$	558	$	36,576
Net increase in cash and cash equivalents	$	27,970	$	36,259

Cash provided by (used in) operating activities

The cash provided by or used for operating activities generally approximates our net loss adjusted for non-cash items and changes in operating assets and liabilities.

Cash provided by operating activities was $13.9 million for the three months ended March 31, 2016 reflecting a net loss of $24 million, which was partially offset by non-cash charges of $2.2 million for depreciation and amortization of property, equipment and intangible assets, $4.8 million in shared-based compensation and $0.3 million for amortization of purchased premiums on our marketable securities. The net change in our operating assets and liabilities provided cash of $30.7 million and resulted from: an increase in collaboration receivable of $0.6 million, driven by the collection of $17.8 million from Sandoz for fourth quarter 2015 GLATOPA and Enoxaparin Sodium Injection profit share, partially offset by the addition of a $14.8 million receivable from Sandoz for first quarter 2016 GLATOPA profit share, and a receivable of $3.8 million representing the net amount due from Mylan for its 50% share of collaboration expenses under the cost-sharing arrangement. Additional changes include: an increase in prepaid expenses and other current assets of $0.9 million due to the timing of advance payments to vendors for nonclinical studies and other services and the amortization of those payments; an increase in other long-term assets of $0.7 million for advance payments to vendors for agreements with service periods that extend beyond 12 months; a decrease in accounts payable of $0.7 million due to timing of vendor payments; a decrease in accrued expenses of $8.3 million primarily due to the timing of costs for process development services for our biosimilars and novel therapeutics programs; an increase in deferred revenue of $41.6 million, primarily due to receipt of a $45 million upfront payment from Mylan offset by revenue recognized under the Baxalta and Mylan collaborations; a decrease in other current liabilities of $0.4 million primarily due to adjustments made to the short-term portions of the deferred rent and tenant improvement liabilities to reflect the extension of our 320 Bent Street lease agreement; and an increase in other long-term liabilities of $0.5 million to adjust the long-term portions of the deferred rent and tenant improvement liabilities for the extension of our 320 Bent Street lease agreement.

Cash used in operating activities was $28.6 million for the three months ended March 31, 2015 reflecting a net loss of $21.9 million. The net loss for the period includes $4.4 million of non-cash income, net, in stock compensation for the reversal of prior period stock compensation expense associated with performance-based stock awards. The net loss plus the net change in stock compensation was partially offset by non-cash charges of $2.4 million for depreciation and amortization of property, equipment and intangible assets and $0.3 million for amortization of purchased premiums on our marketable securities. In addition, the net change in our operating assets and liabilities used cash of $5.0 million and resulted from: decreases in accounts receivable and unbilled revenue totaling $1.7 million due to lower Enoxaparin Sodium Injection product revenue resulting from lower units sold and lower pricing due to a new market entrant; a decrease in accounts payable of $1.9 million due to timing of vendor payments; a decrease in accrued expenses of $3.0 million primarily due to the payout of employee bonuses for their performance in 2014; a decrease in deferred revenue of $1.7 million, due to higher quarterly amortization of arrangement consideration under the Baxalta collaboration; and a decrease in other long-term liabilities of $0.2 million, of which $0.1 million represents the amortization of a

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job creation tax award and $0.1 million is the amortization of the tenant improvement allowance over the term of our 320 Bent Street facility lease.

Cash provided by investing activities

Cash provided by investing activities of $13.5 million for the three months ended March 31, 2016 includes cash inflows of $134.4 million from maturities of marketable securities offset by cash outflows of $119.4 million for purchases of marketable securities and $1.5 million for capital equipment and leasehold improvements.

Cash provided by investing activities of $28.3 million for the three months ended March 31, 2015 includes cash inflows of $44.5 million from maturities of marketable securities partially offset by cash outflows of $15.7 million for purchases of marketable securities and $0.5 million for capital equipment and leasehold improvements.

Cash provided by financing activities

Cash provided by financing activities of $0.6 million for the three months ended March 31, 2016 consist solely of proceeds from stock option exercises and purchases of shares of our common stock through our employee stock purchase plan.

Cash provided by financing activities of $36.6 million for the three months ended March 31, 2015 includes $33.7 million of net proceeds from the sale of 2.6 million shares of our common stock under the 2014 ATM Agreement and $2.9 million from stock option exercises and purchases of shares of our common stock through our employee stock purchase plan.

Contractual Obligations

Our major outstanding contractual obligations relate to license maintenance obligations including royalties payable to third parties, purchase commitments to various contractual research and manufacturing organizations and operating lease obligations. The disclosures relating to our contractual obligations in our Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission on February 26, 2016 have not materially changed since we filed that report.

Critical Accounting Policies and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles, or GAAP. The preparation of these consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

Please refer to the significant accounting policies described in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Annual Report on Form 10-K for the year ended December 31, 2015 filed with the SEC on February 26, 2016.

Please refer to Revenue Recognition within Note 2 “Summary of Significant Accounting Policies” to the accompanying condensed consolidated financial statements for our discussion of our revenue recognition policy for our multiple element arrangements. The notes to our consolidated financial statements are contained in Part I, Item I of this Quarterly Report on Form 10-Q.

New Accounting Standards

Please refer to Note 2 “Summary of Significant Accounting Policies” to the accompanying condensed consolidated financial statements for a discussion of new accounting standards. The notes to our consolidated financial statements are contained in Part I, Item I of this Quarterly Report on Form 10-Q.

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

We are exposed to market risk related to changes in interest rates. Our current investment policy is to maintain an investment portfolio consisting mainly of United States money market, government-secured, and high-grade corporate securities, directly or through managed funds, with maturities of twenty-four months or less. Our cash is deposited in and invested through highly rated financial institutions in North America. Our marketable securities are subject to interest rate risk and will fall in value if market interest rates increase. However, due to the

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conservative nature of our investments, low prevailing market rates and relatively short effective maturities of debt instruments, interest rate risk is mitigated. If market interest rates were to increase immediately and uniformly by 10% from levels at March 31, 2016, we estimate that the fair value of our investment portfolio would decline by an immaterial amount. We do not own derivative financial instruments in our investment portfolio. Accordingly, we do not believe that there is any material market risk exposure with respect to derivative, foreign currency or other financial instruments that would require disclosure under this item.

Item 4. CONTROLS AND PROCEDURES

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, as of March 31, 2016. Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of March 31, 2016, our disclosure controls and procedures were effective at the reasonable assurance level.

There was no change in our internal control over financial reporting during the quarter ended March 31, 2016 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II. OTHER INFORMATION

Item 1. LEGAL PROCEEDINGS

M356-Related Proceedings

On September 10, 2014, Teva and Yeda filed suit against us and Sandoz Inc. in the United States Federal District Court in the District of Delaware in response to the filing by Sandoz Inc. of the ANDA with a Paragraph IV certification for M356. The suit initially alleged infringement related to two Orange Book-listed patents for COPAXONE 40 mg/mL, each expiring in 2030, and seeks declaratory and injunctive relief prohibiting the launch of our product until the last to expire of these patents. In April 2015, Teva and Yeda filed an additional suit against us and Sandoz Inc. in the United States District Court for the District of Delaware alleging infringement related to a third Orange Book-listed patent for COPAXONE 40 mg/mL, which issued in March 2015 and expires in 2030. In May 2015, this suit was consolidated with the initial suit filed in September 2014. In November 2015, Teva and Yeda filed a suit against us and Sandoz Inc. in the United States District Court for the District of Delaware alleging infringement related to a fourth Orange Book-listed patent for COPAXONE 40 mg/mL, which issued in October 2015 and expires in 2030. Teva and Yeda seek declaratory and injunctive relief prohibiting the launch of M356 until the expiration of this patent. In December 2015, this suit was consolidated with the initial suit filed in September 2014. We and Sandoz Inc. have asserted various defenses and filed counterclaims for declaratory judgments of non-infringement, invalidity and unenforceability of the COPAXONE 40 mg/mL patents. A pre-trial claim construction hearing was held in February 2016 and the trial is scheduled to begin in September 2016.

M834-Related Proceedings

On July 2, 2015, we filed a petition for Inter Partes Review, or IPR, with the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office, or PTAB, to challenge the validity of U.S. Patent No 8,476,239, a patent for ORENCIA owned by Bristol Myers Squibb (BMS). The PTAB issued a decision instituting the IPR proceedings in January 2016, and BMS filed for a rehearing by the full PTAB. Briefings by the parties will take place in 2016, with oral arguments scheduled for September 2016. A final opinion from the PTAB is expected in January 2017.

Enoxaparin Sodium Injection-Related Proceedings

On September 21, 2011, we and Sandoz Inc. sued Amphastar and Actavis in the United States District Court for the District of Massachusetts for infringement of two of our patents. Also in September, 2011, we filed a request for a temporary restraining order and preliminary injunction to prevent Amphastar and Actavis from selling their enoxaparin product in the United States. In October 2011, the District Court granted our motion for a preliminary injunction and entered an order enjoining Amphastar and Actavis from advertising, offering for sale or selling their enoxaparin product in the United States until the conclusion of a trial on the merits and required us and Sandoz to post a security bond of $100 million in connection with the litigation. Amphastar and Actavis appealed the decision to the Court of Appeals for the Federal Circuit, or CAFC, and in January 2012, the CAFC stayed the preliminary injunction. In August 2012, the CAFC vacated the preliminary injunction and remanded the case to the District Court. In September 2012, we filed a petition with the CAFC for rehearing by the full court en banc, which was denied. In February 2013, we filed a petition for a writ of certiorari for review of the CAFC decision by the United States Supreme Court and in June 2013 the Supreme Court denied the petition.

In July 2013, the District Court granted a motion by Amphastar and Actavis for summary judgment. We filed a notice of appeal of that decision to the CAFC. In February 2014, Amphastar filed a motion to the CAFC for summary affirmance of the District Court ruling, which the CAFC denied in May 2014. On November 10, 2015, the CAFC affirmed the District Court summary judgment decision with respect to Actavis, reversed the District Court summary judgment decision with respect to Amphastar, and remanded the case against Amphastar to the District Court. On January 11, 2016, Amphastar filed a petition for rehearing by the CAFC, which was denied on February 17, 2016.

In the event that we are not successful in further prosecution or settlement of this action against Amphastar, and Amphastar is able to prove it suffered damages as a result of the preliminary injunction, we could be liable for damages for up to $35 million of the security bond. Amphastar has filed motions to increase the amount of the security bond, which we and Sandoz Inc. have opposed. Litigation involves many risks and uncertainties, and there is no assurance that we or Sandoz Inc. will prevail in this patent enforcement suit.

On September 17, 2015, Amphastar filed a complaint against us and Sandoz Inc. in the United States District Court for the Central District of California. The complaint alleges that, in connection with filing the September 2011 patent infringement suit against Amphastar and Actavis, we and Sandoz Inc. sought to prevent Amphastar from selling generic enoxaparin sodium injection and thereby exclude competition for generic enoxaparin sodium injection in violation of federal and California anti-trust laws and California unfair business laws. Amphastar is seeking unspecified damages and fees. In December 2015, we and Sandoz Inc. filed a motion to dismiss and a motion to transfer the case. In January 2016, the case was transferred to the United States District Court for the District of Massachusetts. In February 2016, Amphastar filed

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a writ of mandamus with the United States Court of Appeals for the Ninth Circuit requesting that court to reverse and review the District Court’s grant of transfer. While the outcome of litigation is inherently uncertain, we believe this suit is without merit, and we intend to vigorously defend ourself in this litigation.

On October 14, 2015, The Hospital Authority of Metropolitan Government of Nashville and Davidson County, Tennessee, d/b/a Nashville General Hospital (“NGH”) filed a class action suit against us and Sandoz Inc. in the United States District Court for the Middle District of Tennessee on behalf of certain purchasers of LOVENOX or generic enoxaparin sodium injection. The complaint alleges that, in connection with filing the September 2011 patent infringement suit against Amphastar and Actavis, we and Sandoz Inc. sought to prevent Amphastar from selling generic enoxaparin sodium injection and thereby exclude competition for generic enoxaparin sodium injection in violation of federal anti-trust laws. NGH is seeking injunctive relief, disgorgement of profits and unspecified damages and fees. In December 2015, we and Sandoz Inc. filed a motion to dismiss and a motion to transfer the case to the United States District Court for the District of Massachusetts. Hearings on the motions were held in February 2016 and April 2016, respectively. These motions are pending before the court. While the outcome of litigation is inherently uncertain, we believe this suit is without merit, and we intend to vigorously defend ourself in this litigation.

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Item 1A. RISK FACTORS

Investing in our stock involves a high degree of risk. You should carefully consider the risks and uncertainties and other important factors described below in addition to other information included or incorporated by reference in this Quarterly Report on Form 10-Q before purchasing our stock. If any of the following risks actually occur, our business, financial condition or results of operations would likely suffer.

Risks Relating to Our Business

We have incurred a cumulative loss since inception. If we do not generate significant revenue, we may not return to profitability.

We have incurred significant losses since our inception in May 2001. At March 31, 2016, our accumulated deficit was $476.4 million. We may incur annual operating losses over the next several years as we expand our drug development, commercialization and discovery efforts. In addition, we must successfully develop and obtain regulatory approval for our drug candidates, and effectively manufacture, market and sell any drugs we successfully develop. Accordingly, we may not generate significant revenue in the longer term and, even if we do generate significant revenue, we may never achieve long-term profitability.

To be profitable, we and our collaborative partners must succeed in developing and commercializing drugs with significant market potential. This will require us and our collaborative partners to be successful in a range of challenging activities: developing product candidates; obtaining regulatory approval for product candidates through either existing or new regulatory approval pathways; clearing allegedly infringing patent rights; enforcing our patent rights; and manufacturing, distributing, marketing and selling products. Our potential profitability will also be adversely impacted by the entry of competitive products and, if so, the degree of the impact could be affected by whether the entry is before or after the launch of our products. We may never succeed in these activities and may never generate revenues that are significant.

Even if M356 (our generic product candidate for three-times-weekly COPAXONE 40 mg/mL) is approved by the FDA, if Teva is successful in the current M356 ANDA-related patent infringement litigation, we and Sandoz may not launch M356 until the relevant COPAXONE patents expire, or we may have to pay significant damages if we launch before those patents expire and they are ultimately determined to be enforceable, valid and infringed. In addition, Teva may allege that we and Sandoz, in manufacturing and selling GLATOPA and/or M356, are infringing COPAXONE patents other than those at issue in our current M356 patent litigation. If this occurs we may expend substantial resources in resulting litigation, the outcome of which would be uncertain. Any unfavorable outcome in such litigation could decrease or halt GLATOPA sales or future M356 sales, if any, prior to a successful defense of such litigation or expiration of any such patents, and we and Sandoz may incur significant damages, reducing our profits and having a material adverse effect on our business.

Should Teva succeed in the current M356 ANDA-related patent infringement litigation, the launch of M356, if approved, may not occur until the patents expire, which would impair our ability to commercialize M356 and would harm our business and financial condition. If M356 is approved by the FDA prior to a decision in the patent infringement litigation, and we and Sandoz launch prior to such decision, we may not be able to utilize M356 product revenue until the conclusion of the litigation, and if Teva is ultimately successful, we and Sandoz may be liable for significant damages, including damages in excess of M356 product revenue, and our business and financial condition would be materially harmed. The possibility of incurring liability for such damages may reduce the scope of, or may delay, any launch of M356 prior to a favorable outcome of the patent infringement litigation. In addition, if we are unsuccessful in litigation, or pending the outcome of litigation or while litigation is pending, a court could issue a temporary injunction or a permanent injunction preventing us from manufacturing and selling M356 and prohibiting the use of previously manufactured product for commercial sale until a favorable outcome of the litigation or the expiration of the patents.

Teva may also assert that our manufacturing and sale of M356 and/or GLATOPA infringes COPAXONE-related patents other than those at issue in the current M356 ANDA-related patent infringement litigation, including patents that may issue in the future. If so, we would expect to incur significant expenses under the terms of our collaboration with Sandoz to respond to and litigate these claims. Furthermore, we may be ordered to pay damages from the sale of M356 and/or GLATOPA if we are found to have infringed Teva’s patents. Litigation concerning intellectual property and proprietary technologies can be protracted and expensive, and can distract management and other key personnel from running our business.

If other generic versions of the brand name drugs, or other biosimilars of the reference products, for which we have products or product candidates, including GLATOPA, M356, M923 and M834, are approved and successfully commercialized, our business would suffer.

Generic versions of our products can contribute most significantly to revenues at the time of their launch, especially with limited competition. As such, the timing of competition can have a significant impact on our financial results. We expect that certain of our product candidates may face intense and increasing competition from other manufacturers of generic and/or branded products. For example, Mylan

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announced that the FDA had accepted for filing its ANDAs for generic versions of COPAXONE and Synthon announced that it submitted ANDAs to the FDA for generic versions of COPAXONE. A launch of an additional generic version of COPAXONE could significantly reduce anticipated revenue from GLATOPA.

Furthermore, as patents for branded products and related exclusivity periods expire, manufacturers of generic products may receive regulatory approval for generic equivalents and may be able to achieve significant market share. As this happens, and as branded manufacturers launch authorized generic versions of such products, market share, revenues and gross profit typically decline, in some cases, dramatically. If any of our current or potential future generic or biosimilar product offerings, including GLATOPA, M356, M923 and M834 enter markets with a number of competitors, we may not achieve significant market share, revenues or gross profit. In addition, as other generic products are introduced to the markets in which we participate, the market share, revenues and gross profit of our generic products would likely decline significantly. In addition, the first biosimilar determined to be interchangeable with a particular reference product for any condition of use is eligible for a period of market exclusivity that delays an FDA determination that a second or subsequent biosimilar product is interchangeable with that reference product for any condition of use until the earlier of: (1) one year after the first commercial marketing of the first interchangeable product; (2) 18 months after resolution of a patent infringement suit instituted under 42 U.S.C. § 262(l)(6) against the applicant that submitted the application for the first interchangeable product, based on a final court decision regarding all of the patents in the litigation or dismissal of the litigation with or without prejudice; (3) 42 months after approval of the first interchangeable product, if a patent infringement suit instituted under 42 U.S.C. § 262(l)(6) against the applicant that submitted the application for the first interchangeable product is still ongoing; or (4) 18 months after approval of the first interchangeable product if the applicant that submitted the application for the first interchangeable product has not been sued under 42 U.S.C. § 262(l)(6). A determination that another company’s product is interchangeable with HUMIRA or another of the reference brand products for which we have a product candidate prior to approval of M923 or other applicable product candidate may therefore delay the potential determination that our product is interchangeable with the reference product, which may materially adversely affect our results of operations and delay, prevent or limit our ability to generate revenue.

If an alternative version of a name brand drug or reference product, such as COPAXONE or HUMIRA, is developed that has a new product profile and labeling, the alternative version of the product could significantly reduce the market share of the original name brand drug or reference product, and may cause a significant decline in sales or potential sales of our corresponding generic or biosimilar product.

Brand companies may develop alternative versions of a reference brand product as part of a life cycle extension strategy, and may obtain approval of the alternative version under a supplemental new drug application, for a drug, or biologics license application for a biologic. The alternative version may offer patients added benefits such as a more convenient form of administration or dosing regimen. Should the brand company succeed in obtaining an approval of an alternative product, it may capture a significant share of the collective reference brand product market and significantly reduce the market for the original reference brand product and thereby the potential size of the market for our generic or biosimilar products. For example, Teva’s three-times-weekly COPAXONE 40 mg/mL, which launched in early 2014, accounts for more than 70% of the overall U.S. glatiramer acetate market (20 mg/mL and 40mg/mL). As a result, the market potential for GLATOPA has decreased, and may decrease further as additional patients are converted from once-daily COPAXONE to three-times-weekly COPAXONE. In addition, the alternative product may be protected by additional patent rights as well as have the benefit, in the case of drugs, of an additional three years of FDA marketing approval exclusivity, which would prohibit a generic version of the alternative product for some period of time. As a result, our business, including our financial results and our ability to fund future discovery and development programs, would suffer.

If the market for a name brand drug or reference product, such as COPAXONE, HUMIRA or ORENCIA, significantly declines, sales or potential sales of our corresponding generic and biosimilars product and product candidates may suffer and our business would be materially impacted.

Competition in the biotechnology industry is intense. Brand name products face competition on numerous fronts as technological advances are made or new products are introduced that may offer patients a more convenient form of administration, increased efficacy or improved safety profile. As new products are approved that compete with the reference brand product to our generic product and generic or biosimilar product candidates, such as COPAXONE, sales of the reference brand products may be significantly and adversely impacted and may render the reference brand product obsolete.

Current injectable treatments commonly used to treat multiple sclerosis, including COPAXONE, are competing with novel therapeutic products, including oral therapies. These oral therapies may offer patients a more convenient form of administration than COPAXONE and may provide increased efficacy.

If the market for the reference brand product is impacted, we in turn may lose significant market share or market potential for our generic or biosimilar products and product candidates, and the value for our generic or biosimilar pipeline could be negatively impacted. As a result, our business, including our financial results and our ability to fund future discovery and development programs, would suffer.

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We will require substantial funds and may require additional capital to execute our business plan and, if additional capital is not available, we may need to delay, limit or cease our product development efforts or other operations. If we are unable to fund our obligations under our collaboration agreements, we may breach those agreements and our collaboration partners could terminate those agreements.

As of March 31, 2016, we had cash, cash equivalents and marketable securities totaling approximately $362.8 million. For the three months ended March 31, 2016, we had a net loss of $24 million and our operations provided cash of $13.9 million. We will continue to require substantial funds to conduct research and development, process development, manufacturing, nonclinical testing and clinical trials of our product candidates, as well as funds necessary to manufacture and market products that are approved for commercial sale. Because successful development and commercialization of our drug candidates is uncertain, we are unable to estimate the actual funds we will require to complete research and development and commercialize our products under development.

Our future capital requirements will depend on many factors, including but not limited to:

· the level of sales of GLATOPA;

· the successful commercialization of M356 and our other product candidates;

· the cost of advancing our product candidates and funding our development programs, including the costs of nonclinical and clinical studies and obtaining regulatory approvals;

· the receipt of milestone payments under our Baxalta Collaboration Agreement and continuation payments under our Mylan Collaboration Agreement;

· the continuation of activities under our Baxalta Collaboration Agreement without disruption following the combination of Baxalta and Shire plc;

· the timing of FDA approval of the products of our competitors;

· the cost of litigation, including with Amphastar relating to enoxaparin, that is not otherwise covered by our collaboration agreement, or potential patent litigation with others, as well as any damages, including possibly treble damages, that may be owed to third parties should we be unsuccessful in such litigation;

· the ability to enter into additional collaborations for our non-partnered programs, as well as the terms and timing of any milestone, royalty or profit share payments thereunder;

· the continued progress in our research and development programs, including completion of our nonclinical studies and clinical trials;

· the cost of acquiring and/or in-licensing other technologies, products or assets; and

· the cost of manufacturing, marketing and sales activities, if any.

We expect to finance and manage our planned operating and capital expenditure requirements principally through our current cash, cash equivalents and marketable securities, capital raised through our collaboration agreements and equity financings, including utilization of our At-the-Market financing facility. We believe that these funds will be sufficient to meet our operating requirements through at least the end of 2018. We may seek additional funding in the future through third-party collaborations and licensing arrangements, public or private debt financings or from other sources. Any additional capital raised through the sale of equity may dilute existing investors’ percentage ownership of our common stock. Capital raised through debt financing would require us to make periodic interest payments and may impose potentially restrictive covenants on the conduct of our business. Additional funds may not be available to us on acceptable terms or at all. In addition, the terms of any financing may adversely affect the holdings or the rights of our stockholders. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail one or more of our research or development programs. We also may not be able to fund our obligations under one or more of our collaboration agreements, which could enable one or more of our collaborators to terminate their agreements with us, and therefore harm our business, financial condition and results of operations.

We may need to enter into collaborations, joint ventures or other alliances with other companies that can provide capabilities and funds for the development and commercialization of our product candidates. If we are unsuccessful in forming or maintaining these arrangements on favorable terms, our business could be adversely affected.

Because we have limited or no internal capabilities for late-stage product development, manufacturing, sales, marketing and distribution, we may need to enter into strategic alliances with other companies. For example, we have entered into collaboration agreements to develop and commercialize our complex generics programs and our biosimilar programs. In the future, we may also find it necessary to form similar

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strategic alliances with major pharmaceutical companies to jointly develop and/or commercialize other product candidates across our product areas. In such alliances, we would expect our collaboration partners to provide substantial capabilities in clinical development, manufacturing, regulatory affairs, sales and marketing. We may not be successful in entering into any such alliances. Even if we do succeed in securing such alliances, we may not be able to maintain them if, for example, development or approval of a product candidate is delayed or sales of an approved product are disappointing. If we are unable to secure or maintain such alliances we may not have the capabilities necessary to continue or complete development of our product candidates and bring them to market, which may have an adverse effect on our business.

In addition to product development and commercialization capabilities, we may depend on our alliances with other companies to provide substantial additional funding for development and potential commercialization of our product candidates. These arrangements may require us to relinquish rights to some of our technologies, product candidates or products which we would otherwise pursue on our own. These alliances may also involve the other company purchasing a significant number of shares of our common stock. Future alliances may involve similar or greater sales of equity, debt financing or other funding arrangements. We may not be able to obtain funding on favorable terms from these alliances, and if we are not successful in doing so, we may not have sufficient funds to develop a particular product candidate internally or to bring product candidates to market. Failure to bring our product candidates to market will prevent us from generating sales revenue, and this may substantially harm our business. Furthermore, any delay in entering into these alliances could delay the development and commercialization of our product candidates and reduce their competitiveness even if they reach the market. As a result, our business and operating results may be adversely affected.

Our future GLATOPA product revenue is dependent on the continued successful commercialization of GLATOPA.

Our near-term ability to generate GLATOPA product revenue depends, in large part, on Sandoz’ continued ability to manufacture and commercialize GLATOPA, maintain pricing levels and market share and compete with Teva’s three-times-weekly COPAXONE 40 mg/mL, which currently accounts for more than 70% of the overall U.S. glatiramer acetate market (20 mg/mL and 40mg/mL). Because GLATOPA is only a substitutable generic version of the once-daily 20 mg/mL formulation of COPAXONE, the market potential of GLATOPA is negatively impacted by the conversion of patients from once-daily COPAXONE to three-times-weekly COPAXONE. In addition, other competitors may in the future receive approval to market generic versions of the 20 mg/mL formulation of COPAXONE which would further impact our product revenue, which is based on a fifty-percent contractual profit share and, as a result, our business, including our near-term financial results and our ability to utilize GLATOPA revenue to fund future discovery and development programs, may suffer.

Any future Enoxaparin product revenue is dependent on the continued successful manufacture and commercialization of Enoxaparin Sodium Injection.

Our near-term ability to generate Enoxaparin product revenue depends, in large part, on Sandoz’ continued ability to manufacture and commercialize Enoxaparin Sodium Injection, maintain pricing levels and market share and compete with LOVENOX brand competition as well as authorized and other generic competition.

Sandoz is facing increasing competition and pricing pressure from brand, authorized generic and other currently-approved generic competitors, which has and will continue to impact Sandoz’ net sales and profits from Enoxaparin Sodium Injection, and therefore our product revenue. Furthermore, other competitors may in the future receive approval to market generic enoxaparin products which would further impact our product revenue, which is based on a fifty-percent contractual profit share.

Due to these circumstances, the resulting market price for our Enoxaparin Sodium Injection product has substantially decreased and may decrease further. In the year ended December 31, 2015, we received $5.1 million in product revenue from Sandoz’ sales of Enoxaparin Sodium Injection, and we do not anticipate significant enoxaparin revenue in the near term. As a result, our business, including our near-term financial results, may suffer.

If our patent litigation against Amphastar related to Enoxaparin Sodium Injection is not successful or Amphastar or others are successful in anti-trust lawsuits against us relating to Enoxparin Sodium Injection, we may be liable for damages and our business may be materially harmed.

In the event that we are not successful in our continued prosecution of our suit against Amphastar and Amphastar is able to prove it suffered damages as a result of the preliminary injunction preventing it from selling its enoxaparin product in the United States having been in effect, we could be liable for up to $35 million of the security bond for such damages. This amount may be increased if Amphastar is successful in their motion to increase the amount of the security bond. Moreover, if Amphastar or others are successful in the anti-trust lawsuits against us for asserting our enoxaparin patent rights, they may be able to recover damages incurred as a result of enforcement of our patent rights, thereby negatively affecting our financial condition and results of operations.

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If efforts by manufacturers of brand name drugs and reference products to delay or limit the use of generics or biosimilars are successful, our sales of generic and biosimilar products may suffer.

Many manufacturers of branded products have increasingly used legislative, regulatory and other means to delay regulatory approval and to seek to restrict competition from manufacturers of generic drugs and could be expected to use similar tactics to delay competition from biosimilars. These efforts have included:

· settling patent lawsuits with generic or biosimilar companies, resulting in such patents remaining an obstacle for generic or biosimilar approval by others;

· seeking to restrict biosimilar commercialization options by making mandatory the optional right to adjudicate patent rights under Section 351(l) of the Biologics Price, Competition and Innovation Act or restricting access by biosimilar and generic applicants to the use of inter partes patent review proceedings at the U.S. Patent Office to challenge invalid biologic patent rights;

· settling paragraph IV patent litigation with generic companies to prevent the expiration of the 180-day generic marketing exclusivity period or to delay the triggering of such exclusivity period;

· submitting Citizen Petitions to request the FDA Commissioner to take administrative action with respect to prospective and submitted generic drug or biosimilar applications or to influence the adoption of policy with regard to the submission of biosimilar applications;

· appealing denials of Citizen Petitions in United States federal district courts and seeking injunctive relief to reverse approval of generic drug or biosimilar applications;

· restricting access to reference brand products for equivalence and biosimilarity testing that interfere with timely generic and biosimilar development plans, respectively;

· conducting medical education with physicians, payers and regulators that claim that generic or biosimilar products are too complex for generic or biosimilar approval and influence potential market share;

· seeking state law restrictions on the substitution of generic and biosimilar products at the pharmacy without the intervention of a physician or through other restrictive means such as excessive recordkeeping requirements or patient and physician notification;

· seeking federal or state regulatory restrictions on the use of the same non-proprietary name as the reference brand product for a biosimilar or interchangeable biologic;

· seeking federal reimbursement policies that do not promote adoption of biosimilars and interchangeable biologics;

· seeking changes to the United States Pharmacopeia, an industry recognized compilation of drug and biologic standards;

· pursuing new patents for existing products or processes which could extend patent protection for a number of years or otherwise delay the launch of generic drugs or biosimilars; and

· influencing legislatures so that they attach special regulatory exclusivity or patent extension amendments to unrelated federal legislation.

The FDA’s practice is to rule within 150 days on Citizen Petitions that seek to prevent approval of an ANDA if the petition was filed after the Medicare Prescription Drug Improvement and Modernization Act of 2003, or MMA. If, at the end of the 150-day period, the ANDA is not ready for approval or rejection, then the FDA has typically denied and dismissed the petition without acting on the petition. For example, Teva Neuroscience, Inc. filed eight Citizen Petitions regarding GLATOPA, all of which have been denied, dismissed or withdrawn. Teva also sought reversal of the denial of a Citizen Petition in federal court. Other third parties may also file Citizen Petitions requesting that the FDA adopt specific approval standards for generic or biosimilar products. Teva may seek to file additional Citizen Petitions pertaining to the 40mg M356 ANDA, and seek to delay or prevent the FDA approval of the 40mg M356 ANDA, which could materially harm our business.

If these efforts to delay or block competition are successful, we may be unable to sell our generic products, which could have a material adverse effect on our sales and profitability.

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If we or our collaborative partners and other third parties are unable to satisfy FDA quality standards and related regulatory requirements, experience manufacturing difficulties or are unable to manufacture sufficient quantities of our products or product candidates, our development and commercialization efforts may be materially harmed.

We have limited personnel with experience in, and we do not own facilities for, manufacturing any products. We depend upon our collaborative partners and other third parties to provide raw materials meeting FDA quality standards and related regulatory requirements, manufacture the drug substance, produce the final drug product and provide certain analytical services with respect to our products and product candidates. We, our collaborative partners or our third-party contractors may have difficulty meeting FDA manufacturing requirements, including, but not limited to, reproducibility, validation and scale-up, and continued compliance with current good manufacturing practices requirements. If we, our collaborative partners or our third-party manufacturers or suppliers are unable to satisfy the FDA manufacturing requirements for our products and product candidates, or are unable to produce our products in sufficient quantities to meet the requirements for the launch of the product or to meet market demand, our revenue and gross margins could be adversely affected, which could have a material adverse impact on our business.

Competition in the biotechnology and pharmaceutical industries is intense, and if we are unable to compete effectively, our financial results will suffer.

The markets in which we intend to compete are undergoing, and are expected to continue to undergo, rapid and significant technological change. We expect competition to intensify as technological advances are made or new biotechnology products are introduced. New developments by competitors may render our current or future product candidates and/or technologies non-competitive, obsolete or not economical. Our competitors’ products may be more efficacious or marketed and sold more effectively than any of our products.

Many of our competitors have:

· significantly greater financial, technical and human resources than we have at every stage of the discovery, development, manufacturing and commercialization process;

· more extensive experience in commercializing generic drugs, conducting nonclinical studies, conducting clinical trials, obtaining regulatory approvals, challenging patents and manufacturing and marketing pharmaceutical products;

· products that have been approved or are in late stages of development; and

· collaborative arrangements in our target markets with leading companies and/or research institutions.

If we successfully develop and obtain approval for our drug candidates, we will face competition based on many different factors, including:

· the safety and effectiveness of our products;

· with regard to our generic or biosimilar product candidates, the differential availability of clinical data and experience and willingness of physicians, payers and formularies to rely on biosimilarity data;

· the timing and scope of regulatory approvals for these products and regulatory opposition to any product approvals;

· the availability and cost of manufacturing, marketing, distribution and sales capabilities;

· the effectiveness of our marketing, distribution and sales capabilities;

· the price of our products;

· the availability and amount of third-party reimbursement for our products; and

· the strength of our patent positions.

Our competitors may develop or commercialize products with significant advantages in regard to any of these factors. Our competitors may therefore be more successful in commercializing their products than we are, which could adversely affect our competitive position and business.

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If we or our collaborators are unable to establish and maintain key customer distribution arrangements, sales of our products, and therefore revenue, would decline.

Generic pharmaceutical biosimilars products are sold through various channels, including retail, mail order, and to hospitals through group purchasing organizations, or GPOs. The distribution of such products is also managed by pharmacy benefit management firms such as Express Scripts or CVS. These purchasers and pharmacy benefit management firms rely on competitive bidding, discounts and rebates across their purchasing arrangements. We also believe that we, in collaboration with commercial collaboration partners, will need to maintain adequate drug supplies, remain price competitive, comply with FDA regulations and provide high-quality products to establish and maintain these relationships. The GPOs, pharmacy benefit management firms and other customers with whom we or our collaborators have established contracts may also have relationships with our competitors and may decide to contract for or otherwise prefer products other than ours, limiting access of products to certain market segments. Our sales could also be negatively affected by any rebates, discounts or fees that are required by GPOs, pharmacy benefit management firms, and customers, including wholesalers, distributors, retail chains or mail order services, to gain and retain market acceptance for our products. If we or our collaborators are unable to establish and maintain distribution arrangements with all of these customers, sales of our products, our revenue and our profits would suffer.

Even if we receive approval to market our product candidates, the market may not be receptive to our product candidates upon their commercial introduction, which could adversely affect our ability to generate sufficient revenue from product sales to maintain or grow our business.

Even if our product candidates are successfully developed and approved for marketing, our success and growth will also depend upon the acceptance of our products by patients, physicians and third-party payers. Acceptance of our products will be a function of our products being clinically useful, being cost effective and demonstrating superior or biosimilar therapeutic effect with an acceptable side effect profile as compared to existing or future treatments. In addition, even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time.

Factors that we believe will materially affect market acceptance of our product candidates under development include:

· the timing of our receipt of any marketing approvals, the terms of any approval and the countries in which approvals are obtained;

· the safety, efficacy and ease of administration of our products;

· the competitive pricing of our products;

· physician confidence in the safety and efficacy of complex generic products or biosimilars;

· the absence of, or limited clinical data available from sameness, biosimilarity or interchangeability testing of our complex generic or biosimilar products;

· the success and extent of our physician education and marketing programs;

· the clinical, medical affairs, sales, distribution and marketing efforts of competitors; and

· the availability and amount of government and third-party payer reimbursement.

If our products do not achieve market acceptance, we will not be able to generate sufficient revenue from product sales to maintain or grow our business.

If we are not able to retain our current management team or attract and retain qualified scientific, technical and business personnel, our business will suffer.

We are dependent on the members of our management team for our business success. Our employment arrangements with our executive officers are terminable by either party on short notice or no notice. We do not carry key person life insurance on the lives of any of our personnel. The loss of any of our executive officers would result in a significant loss in the knowledge and experience that we, as an organization, possess and could cause significant delays, or outright failure, in the development and approval of our product candidates. In addition, there is intense competition from numerous pharmaceutical and biotechnology companies, universities, governmental entities and other research institutions, for human resources, including management, in the technical fields in which we operate, and we may not be able to attract and retain qualified personnel necessary for the successful development and commercialization of our product candidates. Another component of retention is the intrinsic value of equity awards, including stock options. Many stock options granted to our executives and employees are now under pressure given our recent stock performance. If we lose key members of our management team, or are unable to attract and retain qualified personnel, our business could be negatively affected.

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There is a substantial risk of product liability claims in our business. If our existing product liability insurance is insufficient, a product liability claim against us that exceeds the amount of our insurance coverage could adversely affect our business.

Our business exposes us to significant potential product liability risks that are inherent in the development, manufacturing and marketing of human therapeutic products. Product liability claims could delay or prevent completion of our development programs. If we succeed in marketing products, such claims could result in a recall of our products or a change in the approved indications for which they may be used. We cannot be sure that the product liability insurance coverage we maintain will be adequate to cover any incident or all incidents. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable to maintain sufficient insurance at a reasonable cost to protect us against losses that could have a material adverse effect on our business. These liabilities could prevent or interfere with our product development and commercialization efforts.

Our business and operations would suffer in the event of system failures or security breaches.

Our internal computer systems are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Any system failure or security breach by employees or others may pose a risk that sensitive data, including clinical trial data, intellectual property, trade secrets or personal information belonging to us, our patients or our collaborators may be exposed to unauthorized persons or to the public. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Likewise, we rely on third parties to manufacture and commercialize our products and conduct clinical trials, and similar events relating to their computer systems could also have a material adverse effect on our business. To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability, the further development and commercialization of our products and product candidates could be delayed, and the trading price of our common stock could be adversely affected.

As we evolve from a company primarily involved in drug discovery and development into one that is also involved in the development and commercialization of multiple pharmaceutical products, we may have difficulty managing our growth and expanding our operations successfully.

As we advance an increasing number of product candidates through the development process, we will need to expand our development, regulatory, manufacturing, quality, distribution, sales and marketing capabilities or contract with other organizations to provide these capabilities for us. As our operations expand, we expect that we will need to lease additional or alternative facilities and manage additional relationships with various collaborative partners, suppliers and other organizations. The market for laboratory and office facilities is highly competitive near our current location. If we are not successful in leasing additional or alternative space in our current area and have to move our facilities, the timing of our development programs could be disrupted.

In addition, our ability to manage our operations and growth requires us to continue to improve our operational, financial and management controls, reporting systems and procedures. For example, some jurisdictions, such as the District of Columbia, have imposed licensing requirements for sales representatives. In addition, the District of Columbia and the Commonwealth of Massachusetts, as well as the federal government by way of the Sunshine Act provisions of the Patient Protection and Affordable Care Act of 2010, have established reporting requirements that would require public reporting of consulting and research fees to health care professionals. Because the reporting requirements vary in each jurisdiction, compliance will be complex and expensive and may create barriers to entering the commercialization phase. The need to build new systems as part of our growth could place a strain on our administrative and operational infrastructure. We may not be able to make improvements to our management information and control systems in an efficient or timely manner and may discover deficiencies in existing systems and controls. Such requirements may also impact our opportunities to collaborate with physicians at academic research centers as new restrictions on academic-industry relationships are put in place. In the past, collaborations between academia and industry have led to important new innovations, but the new laws may have an effect on these activities. While we cannot predict whether any legislative or regulatory changes will have negative or positive effects, they could have a material adverse effect on our business, financial condition and potential profitability.

We may incur costs and allocate resources to identify and develop additional product candidates or acquire or make investments in companies or technologies without realizing any benefit, which could have an adverse effect on our business, results of operations and financial condition or cash flows.

Along with continuing to progress our current product candidates, the long-term success of our business also depends on our ability to successfully identify, develop and commercialize additional product candidates. Research programs to identify new product candidates require substantial technical, financial and human resources. We may focus our efforts and resources on potential programs and product candidates that ultimately prove to be unsuccessful.

In addition, we may acquire or invest in companies, products and technologies. Such transactions involve a number of risks, including:

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· we may find that the acquired company or assets does not further our business strategy, or that we overpaid for the company or assets, or that economic conditions change, all of which may generate a future impairment charge;

· difficulty integrating the operations and personnel of the acquired business, and difficulty retaining the key personnel of the acquired business;

· difficulty incorporating the acquired technologies;

· difficulties or failures with the performance of the acquired technologies or drug products;

· we may face product liability risks associated with the sale of the acquired company’s products;

· disruption or diversion of management’s attention by transition or integration issues and the complexity of managing diverse locations;

· difficulty maintaining uniform standards, internal controls, procedures and policies;

· the acquisition may result in litigation from terminated employees or third parties; and

· we may experience significant problems or liabilities associated with product quality, technology and legal contingencies.

These factors could have a material adverse effect on our business, results of operations and financial condition or cash flows, particularly in the case of a larger acquisition or multiple acquisitions in a short period of time. From time to time, we may enter into negotiations for acquisitions that are not ultimately consummated. Such negotiations could result in significant diversion of management time, as well as out-of-pocket costs.

The consideration paid in connection with an acquisition also affects our financial results. If we were to proceed with one or more significant acquisitions in which the consideration included cash, we could be required to use a substantial portion of our available cash to consummate any acquisition. To the extent we issue shares of stock or other rights to purchase stock, including options or other rights, existing stockholders may be diluted and earnings per share may decrease. In addition, acquisitions may result in the incurrence of debt, large one-time write-offs and restructuring charges. They may also result in goodwill and other intangible assets that are subject to impairment tests, which could result in future impairment charges.

If we fail to maintain appropriate internal controls in the future, we may not be able to report our financial results accurately, which may adversely affect our stock price and our business.

Our efforts to comply with Section 404 of the Sarbanes-Oxley Act of 2002 and the related regulations regarding our required assessment of our internal controls over financial reporting and our external auditors’ audit of that assessment requires the commitment of significant financial and managerial resources.

Internal control over financial reporting has inherent limitations, including human error, the possibility that controls could be circumvented or become inadequate because of changed conditions, and fraud. If we are unable to maintain effective internal controls, we may not have adequate, accurate or timely financial information, and we may be unable to meet our reporting obligations as a publicly traded company or comply with the requirements of the SEC or the Sarbanes-Oxley Act of 2002. This could result in a restatement of our financial statements, the imposition of sanctions, including the inability of registered broker dealers to make a market in our stock, or investigation by regulatory authorities. Any such action or other negative results caused by our inability to meet our reporting requirements or comply with legal and regulatory requirements or by disclosure of an accounting, reporting or control issue could adversely affect the trading price of our stock and our business.

Risks Relating to Development and Regulatory Approval

The future success of our business is significantly dependent on the success of our M356 product candidate. If we are not able to obtain regulatory approval for the commercial sale of our M356 product candidate, our future results of operations will be adversely affected.

Our future results of operations depend to a significant degree on our ability to obtain regulatory approval for and commercialize M356. Our application for M356 has been under review with the FDA since February 2014. To receive approval, we will be required to demonstrate to the satisfaction of the FDA, among other things, that M356:

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· contains the same active ingredients as COPAXONE 40 mg/mL;

· is of the same dosage form, strength and route of administration as COPAXONE 40 mg/mL, and has the same labeling as the approved labeling for COPAXONE 40 mg/mL, with certain exceptions; and

· meets compendia or other applicable standards for strength, quality, purity and identity, including potency.

In addition, approval of a generic product generally requires demonstrating that the generic drug is bioequivalent to the reference listed drug upon which it is based, meaning that there are no significant differences with respect to the rate and extent to which the active ingredients are absorbed and become available at the site of drug action. However, the FDA may or may not waive the requirements for certain bioequivalence data (including clinical data) for certain drug products, including injectable solutions that have been shown to contain the same active and inactive ingredients in the same concentration as the reference listed drug.

Determination of therapeutic equivalence of M356 to COPAXONE 40 mg/mL will be based, in part, on our demonstration of the chemical equivalence of our versions to their respective reference listed drugs. The FDA may not agree that we have adequately characterized M356 or that M356 and COPAXONE 40 mg/mL are chemical equivalents. In that case, the FDA may require additional information, including nonclinical or clinical trial results, to determine therapeutic equivalence or to confirm that any inactive ingredients or impurities do not compromise the product’s safety and efficacy. Provision of sufficient information for approval may be difficult, expensive and lengthy. We cannot predict whether M356 will receive FDA approval as therapeutically equivalent to COPAXONE 40 mg/mL.

In the event that the FDA modifies its current standards for therapeutic equivalence with respect to generic versions of COPAXONE 40 mg/mL, or requires us to conduct clinical trials or complete other lengthy procedures, the commercialization of M356 could be delayed or prevented or become more expensive. Delays in any part of the process or our inability to obtain regulatory approval for M356 could adversely affect our operating results by restricting or significantly delaying our introduction of M356.

Although health care reform legislation that establishes a regulatory pathway for the approval by the FDA of biosimilars has been enacted, the standards for determining biosimilarity and interchangeability for biosimilars are only just being implemented by the FDA. Therefore, substantial uncertainty remains about the potential value of our scientific approach and regulatory strategy for biosimilar development.

The regulatory climate in the United States for follow-on versions of biologic and complex protein products remains uncertain, even following the recent enactment of legislation establishing a regulatory pathway for the approval of biosimilars under the Biologics Price Competition and Innovation Act, or BPCI Act. For example, the FDA only recently issued guidance on certain matters concerning approval of biosimilars, including quality considerations and scientific considerations and to date, only one biosimilar product has been approved, and, to our knowledge, only a limited number of biosimilar applications have been accepted for review by the FDA, and one application has been approved for a biosimilar under the 351(k) pathway. The pathway contemplates approval of two categories of follow-on biologic products: (1) biosimilar products, which are highly similar to the existing brand product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences from the brand product and (2) interchangeable biologic products, which in addition to being biosimilar can be expected to produce the same clinical result in any given patient without an increase in risk due to switching from the brand product. Only interchangeable biosimilar products would be considered substitutable at the retail pharmacy level without the intervention of a physician. The legislation authorizes but does not require the FDA to establish standards or criteria for determining biosimilarity and interchangeability, and also authorizes the FDA to use its discretion to determine the nature and extent of product characterization, nonclinical testing and clinical testing on a product-by-product basis.

Our competitive advantage in this area will depend on our success in demonstrating to the FDA that our analytics, biocharacterization and protein engineering platform technology provides a level of scientific assurance that facilitates determinations of biosimilarity and/or interchangeability, reduces the need for large scale clinical trials or other testing, and raises the scientific quality requirements for our competitors to demonstrate that their products are highly similar to a reference brand product. Our ability to succeed will depend in part on our ability to invest in new programs and develop data in a timeframe that enables the FDA to consider our approach within the context of the biosimilar meeting and application review process. In addition, the FDA will likely require significant new resources and expertise to review biosimilar applications, and the timeliness of the review and approval of our future applications could be adversely affected if there were a decline or even limited growth in FDA funding. Our strategy to reduce and target clinical requirements by relying on analytical and functional nonclinical data may not be successful or may take longer than strategies that rely more heavily on clinical trial data.

The regulatory pathway also creates a number of additional obstacles to the approval and launch of biosimilar and interchangeable products, including:

· a requirement for the applicant, as a condition to using the pre-approval patent exchange and clearance process, to share, in confidence, the information in its abbreviated pathway application with the brand company’s and patent owner’s counsel;

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· the inclusion of multiple potential patent rights in the patent clearance process; and

· a grant to each brand company of 12 years of marketing exclusivity following the brand approval.

Furthermore, the regulatory pathway creates the risk that the brand company, during its 12-year marketing exclusivity period, will develop and replace its product with a non-substitutable or modified product that may also qualify for an additional 12-year marketing exclusivity period, reducing the opportunity for substitution at the retail pharmacy level for interchangeable biosimilars. Finally, the legislation also creates the risk that, as brand and biosimilar companies gain experience with the regulatory pathway, subsequent FDA determinations or court rulings could create additional areas for potential disputes and resulting delays in biosimilars approval.

In addition, there is reconsideration and legislative debate that could lead to the repeal or amendment of the healthcare legislation. If the legislation is significantly amended or is repealed with respect to the biosimilar approval pathway, our opportunity to develop biosimilars (including interchangeable biologics) could be materially impaired and our business could be materially and adversely affected. Similarly, the legislative debate at the federal level regarding the federal government budget in 2013 restricted federal agency funding for the biosimilar pathway, including biosimilar user fee funding for fiscal year 2014, and has resulted in delays in the conduct of meetings with biosimilar applicants and the review of biosimilar meeting and application information. The scheduling and conduct of biosimilar meeting and applications review was also suspended during the U.S. Government shutdown in October 2013, and could be subject to future suspensions as a result of future deadlocks in passage of federal appropriations bills in 2016 or future years. Depending on the timing and the extent of these funding, meeting and review disruptions, our development of biosimilar products could be delayed.

Our opportunity to realize value from the potential of the biosimilars market is difficult and challenging due to the significant scientific and development expertise required to develop and consistently manufacture complex protein biologics.

The market potential of biosimilars may be difficult to realize, in large part due to the challenges of successfully developing and manufacturing biosimilars. Biologics are therapeutic proteins and are much more complex and much more difficult to characterize and replicate than small-molecule, chemically synthesized drugs. Proteins tend to be 100 to 1000 times larger than conventional drugs, and are more susceptible to physical factors such as light, heat and agitation. They also have greater structural complexity. Protein molecules differ from one another primarily in their sequence of amino acids, which results in folding of the protein into a specific three-dimensional structure that determines its activity. Although the sequence of amino acids in a protein is consistently replicated, there are a number of changes that can occur following synthesis that create inherent variability. Chief among these is the glycosylation, or the attachment of sugars at certain amino acids. Glycosylation is critical to protein structure and function, and thoroughly characterizing and matching the glycosylation profile of a targeted biologic is essential and poses significant scientific and technical challenges. Furthermore, it is often challenging to consistently manufacture proteins with complex glycosylation profiles, especially on a commercial scale. Protein-based therapeutics are inherently heterogeneous and their structure is highly dependent on the production process and conditions. Products from one production facility can differ within an acceptable range from those produced in another facility. Similarly, physicochemical differences can also exist among different lots of the same product produced at the same facility. The physicochemical complexity and size of biologics creates significant technical and scientific challenges in their replication as biosimilar products. Accordingly, the technical complexity involved and expertise and technical skill required to successfully develop and manufacture biosimilars poses significant barriers to entry. Any difficulties encountered in developing and producing, or any inability to develop and produce, biosimilars could adversely affect our business, financial condition and results of operations.

Even if we are able to obtain regulatory approval for our generic and biosimilar product candidates as therapeutically equivalent or interchangeable, state pharmacy boards or agencies may conclude that our products are not substitutable at the pharmacy level for the corresponding name brand drug or reference product. If our generic or biosimilar products are not substitutable at the pharmacy level for their corresponding name brand drug or reference product, this could materially reduce sales of our products and our business would suffer.

Although the FDA may determine that a generic product is therapeutically equivalent to a brand product and provide it with an “A” rating in the FDA’s Orange Book, this designation is not binding on state pharmacy boards or agencies for generic drugs. As a result, in states that do not deem our generic drug candidates therapeutically equivalent, physicians will be required to specifically prescribe a generic product alternative rather than have a routine substitution at the pharmacy level for the prescribed brand product. Should this occur with respect to one of our generic product candidates, it could materially reduce sales in those states which would substantially harm our business.

While a designation of interchangeability is a finding by the FDA that a biosimilar can be substituted at the pharmacy without physician intervention or prescription, brand pharmaceutical companies are lobbying state legislatures to enact physician prescription requirements, or in the absence of a prescription, physician and patient notification requirements, special labeling requirements and alternative naming requirements which if enacted could create barriers to substitution and adoption rates of interchangeable biologics as well as biosimilars. Should this occur with respect to one of our biosimilars or interchangeable biologic product candidates, it could materially reduce sales in those states which would substantially harm our business.

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If our nonclinical studies and clinical trials for our novel product candidates, including necuparanib, are not successful, we will not be able to obtain regulatory approval for commercial sale of those product candidates.

To obtain regulatory approval for the commercial sale of our novel product candidates, we are required to demonstrate through nonclinical studies and clinical trials that our drug development candidates are safe and effective. Nonclinical studies and clinical trials of new development candidates are lengthy and expensive and the historical failure rate for development candidates is high.

A failure of one or more of our nonclinical studies or clinical trials can occur at any stage of testing. We may experience numerous unforeseen events during, or as a result of, nonclinical studies and clinical trials that could delay or prevent our ability to receive regulatory approval or commercialize necuparanib or our other drug candidates, including:

· regulators or institutional review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site;

· our nonclinical studies or clinical trials may produce negative or inconclusive results, and we may be required to conduct additional nonclinical studies or clinical trials or we may abandon projects that we previously expected to be promising;

· enrollment in our clinical trials may be slower than we anticipate, resulting in significant delays, and participants may drop out of our clinical trials at a higher rate than we anticipate;

· we might have to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks;

· regulators or institutional review boards may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or if, in their opinion, participants are being exposed to unacceptable health risks;

· the cost of our clinical trials may be greater than we anticipate;

· the effects of our drug candidates may not be the desired effects or may include undesirable side effects or our product candidates may have other unexpected characteristics; and

· we may decide to modify or expand the clinical trials we are undertaking if new agents are introduced that influence current standard of care and medical practice, warranting a revision to our clinical development plan.

The results from nonclinical studies of a development candidate and in initial human clinical studies of a development candidate may not predict the results that will be obtained in subsequent human clinical trials. If we are required by regulatory authorities to conduct additional clinical trials or other testing of necuparanib or our other product candidates that we did not anticipate, if we are unable to successfully complete our clinical trials or other tests, or if the results of these trials are not positive or are only modestly positive, we may be delayed in obtaining marketing approval for our drug candidates or we may not be able to obtain marketing approval at all. Our product development costs will also increase if we experience delays in testing or approvals. Significant clinical trial delays could allow our competitors to bring products to market before we do and impair our ability to commercialize our products or potential products. If any of these events occur, our business will be materially harmed.

Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our products abroad.

We intend in the future to market our products, if approved, outside of the United States, either directly or through collaborative partners. In order to market our products in the European Union and many other foreign jurisdictions, we must obtain separate regulatory approvals and comply with the numerous and varying regulatory requirements of each jurisdiction. The approval procedure and requirements vary among countries, and can require, among other things, conducting additional testing in each jurisdiction. The time required to obtain approval abroad may differ from that required to obtain FDA approval. The foreign regulatory approval process may include all of the risks associated with obtaining FDA approval, and we may not obtain foreign regulatory approvals on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in any other foreign country or by the FDA. We and our collaborators may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our products in any market outside of the United States. The failure to obtain these approvals could materially adversely affect our business, financial condition, and results of operations.

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Even if we obtain regulatory approvals, our marketed products will be subject to ongoing regulatory review. If we fail to comply with continuing United States and foreign regulations, we could lose our approvals to market products and our business would be seriously harmed.

Even after approval, any drugs or biological products we develop will be subject to ongoing regulatory review, including the review of clinical results which are reported after our products are made commercially available. Any regulatory approvals that we obtain for our product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product candidate. In addition, the manufacturer and manufacturing facilities we use to produce any of our product candidates will be subject to periodic review and inspection by the FDA, or foreign equivalent, and other regulatory agencies. We will be required to report any serious and unexpected adverse experiences and certain quality problems with our products and make other periodic reports to the FDA. The discovery of any new or previously unknown problems with the product, manufacturer or facility may result in restrictions on the product or manufacturer or facility, including withdrawal of the product from the market. Certain changes to an approved product, including in the way it is manufactured or promoted, often require prior FDA approval before the product as modified may be marketed. If we fail to comply with applicable FDA regulatory requirements, we may be subject to fines, warning letters, civil penalties, refusal by the FDA to approve pending applications or supplements, suspension or withdrawal of regulatory approvals, product recalls and seizures, injunctions, operating restrictions, refusal to permit the import or export of products, and/or criminal prosecutions and penalties.

Similarly, our commercial activities will be subject to comprehensive compliance obligations under state and federal reimbursement, Sunshine Act, anti-kickback and government pricing regulations. If we make false price reports, fail to implement adequate compliance controls or our employees violate the laws and regulations governing relationships with health care providers, we could also be subject to substantial fines and penalties, criminal prosecution and debarment from participation in the Medicare, Medicaid, or other government reimbursement programs.

In addition, the FDA’s policies may change and additional government regulations may be enacted that could prevent, limit, or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability, which would adversely affect our business.

If third-party payers do not adequately reimburse customers for any of our approved products, they might not be purchased or used, and our revenue and profits will not develop or increase.

Our revenue and profits will depend heavily upon the availability of adequate reimbursement for the use of our approved product candidates from governmental and other third-party payers, both in the United States and in foreign markets. Reimbursement by a third-party payer may depend upon a number of factors, including the third-party payer’s determination that use of a product is:

· a covered benefit under its health plan;

· safe, effective and medically necessary;

· appropriate for the specific patient;

· cost-effective; and

· neither experimental nor investigational.

Obtaining coverage and reimbursement approval for a product from each government or other third-party payer is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products to each payer. We may not be able to provide data sufficient to gain acceptance with respect to coverage and reimbursement. There is substantial uncertainty whether any particular payer will reimburse the use of any drug product incorporating new technology. Even when a payer determines that a product is eligible for reimbursement, the payer may impose coverage limitations that preclude payment for some uses that are approved by the FDA or comparable authority. Moreover, eligibility for coverage does not imply that any product will be reimbursed in all cases or at a rate that allows us to make a profit or even cover our costs. Interim payments for new products, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement rates may vary according to the use of the product and the clinical setting in which it is used, may be based on payments allowed for lower-cost products that are already reimbursed, may be incorporated into existing payments for other products or services, and may reflect budgetary constraints and/or imperfections in Medicare, Medicaid or other data used to calculate these rates. Net prices for products may be reduced by mandatory discounts or rebates required by government health care programs or by any future relaxation of laws that restrict imports of certain medical products from countries where they may be sold at lower prices than in the United States.

There have been, and we expect that there will continue to be, federal and state proposals to constrain expenditures for medical products and services, which may affect payments for our products. The Centers for Medicare and Medicaid Services, or CMS, frequently change

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product descriptors, coverage policies, product and service codes, payment methodologies and reimbursement values. Third-party payers often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, and both CMS and other third-party payers may have sufficient market power to demand significant price reductions. Due in part to actions by third-party payers, the health care industry is experiencing a trend toward containing or reducing costs through various means, including lowering reimbursement rates, limiting therapeutic class coverage and negotiating reduced payment schedules with service providers for drug products.

We also anticipate that application of the existing and evolving reimbursement regimes to biosimilar products will be somewhat uncertain as CMS and private payers determine whether or not to apply generic drug reimbursement approaches to reimbursement or to develop alternative approaches under Medicare, Medicaid and private insurance coverage. For example, under Medicare Part B, the assignment of reimbursement codes to a reference drug product and its generic equivalent creates a strong incentive for generic conversion. CMS has proposed to group all non-interchangeable biosimilars of a reference biologic under a single, separate reimbursement code from the code for the reference biologic. CMS has not determined that interchangeable biologic products should be under the same reimbursement code as their reference biologics. If separate codes are instituted, the value of interchangeability could be reduced or significantly impaired. Reimbursement uncertainty could adversely impact market acceptance of biosimilar products.

Our inability to promptly obtain coverage and profitable reimbursement rates from government-funded and private payers for our products could have a material adverse effect on our operating results and our overall financial condition.

Federal legislation will increase the pressure to reduce prices of pharmaceutical products paid for by Medicare or may otherwise seek to limit healthcare costs, either of which could adversely affect our revenue, if any.

The Medicare Modernization Act of 2003, or MMA, changed the way Medicare covers and reimburses for pharmaceutical products. The legislation introduced a new reimbursement methodology based on average sales prices for drugs that are used in hospital settings or under the direct supervision of a physician and, starting in 2006, expanded Medicare coverage for drug purchases by the elderly. In addition, the MMA requires the creation of formularies for self-administered drugs, and provides authority for limiting the number of drugs that will be covered in any therapeutic class and provides for plan sponsors to negotiate prices with manufacturers and suppliers of covered drugs. As a result of the MMA and the expansion of federal coverage of drug products, we expect continuing pressure to contain and reduce costs of pharmaceutical products. Cost reduction initiatives and other provisions of this legislation could decrease the coverage and price that we receive for our products and could materially adversely affect our operating results and overall financial condition. While the MMA generally applies only to drug benefits for Medicare beneficiaries, private payers often follow Medicare coverage policy and payment limitations in setting their own reimbursement policies and any reduction in coverage or payment that results from the MMA may result in a similar reduction in coverage or payments from private payers.

Furthermore, health care reform legislation that was enacted in 2010 and is now being implemented could significantly change the United States health care system and the reimbursement of products. A primary goal of the law is to reduce or limit the growth of health care costs, which could change the market for pharmaceuticals and biological products.

The law contains provisions that will affect companies in the pharmaceutical industry and other healthcare-related industries by imposing additional costs and changes to business practices. Provisions affecting pharmaceutical companies include an increase to the mandatory rebates for drugs sold into the Medicaid program, an extension of the rebate requirement to drugs used in risk-based Medicaid managed care plans, an extension of mandatory discounts for drug products sold to certain critical access hospitals, cancer hospitals and other covered entities, and discounts and fees applicable to brand-name drugs. Although many of these provisions may not apply directly to us, they may change business practices in our industry and, assuming our products are approved for commercial sale, such changes could adversely impact our profitability.

Additionally, the BPCI Act establishes an abbreviated regulatory pathway for the approval of biosimilars and provides that brand biologic products may receive 12 years of market exclusivity, with a possible six-month extension for pediatric products. By creating a new approval pathway for biosimilars and adjusting reimbursement for biosimilars, the new law could promote the development and commercialization of biosimilars. However, given the uncertainty of how the law will be interpreted and implemented, the impact of the law on our strategy for biosimilars as well as novel biologics remains uncertain. Other provisions in the law, such as the comparative effectiveness provisions, may ultimately impact positively or negatively both brand and biosimilars products alike depending on an applicant’s clinical data, effectiveness and cost profile. If a brand product cannot be shown to provide a benefit over other therapies, then it might receive reduced coverage and reimbursement. While this might increase market share for biosimilars based on cost savings, it could also have the effect of reducing biosimilars’ market share.

The financial impact of this United States health care reform legislation over the next few years will depend on a number of factors, including but not limited to the issuance of implementation regulations and guidance and changes in sales volumes for products eligible for the new system of rebates, discounts and fees.

The full effects of the United States health care reform legislation cannot be known until the new law is implemented through regulations or guidance issued by the CMS and other federal and state health care agencies. While we cannot predict whether any legislative or regulatory changes will have negative or positive effects, they could have a material adverse effect on our business, financial condition and potential

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profitability. In addition, litigation may prevent some or all of the legislation from taking effect. Consequently, there is uncertainty regarding implementation of the new legislation.

Foreign governments tend to impose strict price or reimbursement controls, which may adversely affect our revenue, if any.

In some foreign countries, particularly the countries of the European Union, the pricing and/or reimbursement of prescription pharmaceuticals are subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be adversely affected.

If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.

Our research and development involves, and may in the future involve, the use of hazardous materials and chemicals and certain radioactive materials and related equipment. If an accident occurs, we could be held liable for resulting damages, which could be substantial. We are also subject to numerous environmental, health and workplace safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and the handling of biohazardous materials. Insurance may not provide adequate coverage against potential liabilities and we do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us. Additional federal, state and local laws and regulations affecting our operations may be adopted in the future. We may incur substantial costs to comply with, and substantial fines or penalties if we violate, any of these laws or regulations.

The FDA has reported that it has a substantial backlog of ANDA filings that have resulted in significant delays in review and approval of applications. As a result, the review and potential approval of our applications for M356 may be significantly delayed.

The FDA has reported that it has a substantial backlog of ANDA filings that have resulted in significant delays in the review and approval of ANDAs and amendments or supplements due to insufficient staffing and resources. Resource constraints have also resulted in significant delays in conducting ANDA-related pre-approval inspections. Until the backlog of ANDA filings is reduced, our applications and supplements may be subject to significant delays during their review cycles.

Risks Relating to Patents and Licenses

If we are not able to obtain and enforce patent protection for our discoveries, our ability to successfully commercialize our product candidates will be harmed and we may not be able to operate our business profitably.

Our success depends, in part, on our ability to protect proprietary methods and technologies that we develop under the patent and other intellectual property laws of the United States and other countries, so that we can prevent others from using our inventions and proprietary information. Because patent applications in the United States and many foreign jurisdictions are typically not published until 18 months after filing, or in some cases not at all, and because publications of discoveries in scientific literature lag behind actual discoveries, we cannot be certain that we were the first to make the inventions claimed in issued patents or pending patent applications, or that we were the first to file for protection of the inventions set forth in our patent applications. As a result, we may be required to obtain licenses under third-party patents to market our proposed products. If licenses are not available to us on acceptable terms, or at all, we will not be able to market the affected products.

Assuming the other requirements for patentability are met, the first inventor to file a patent application is entitled to the patent. We may be subject to a third-party preissuance submission of prior art to the U.S. Patent and Trademark Office, or become involved in opposition, derivation, reexamination, inter partes review or interference proceedings challenging our patent rights or the patent rights of others. For example, two of our European patents are being challenged in opposition proceedings before the European Patent Office. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights.

Our strategy depends on our ability to rapidly identify and seek patent protection for our discoveries. This process is expensive and time consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.

Despite our efforts to protect our proprietary rights, unauthorized parties may be able to obtain and use information that we regard as proprietary. The issuance of a patent does not guarantee that it is valid or enforceable, so even if we obtain patents, they may not be valid or enforceable against third parties.

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Our pending patent applications may not result in issued patents. The patent position of pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves complex legal and factual considerations. The standards which the U.S. Patent and Trademark Office and its foreign counterparts use to grant patents are not always applied predictably or uniformly and can change. There is also no uniform, worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents. The laws of some foreign countries do not protect proprietary information to the same extent as the laws of the United States, and many companies have encountered significant problems and costs in protecting their proprietary information in these foreign countries.

While the United States Court of Appeals for the Federal Circuit ruled that the practice of our patented commercial manufacturing test by Amphaster did not fall within the scope of the safe harbor from patent infringement under federal patent law, 35 USC section 271(e)(1), Amphastar may challenge the ruling and there may remain uncertainty in the future regarding enforcement of our patents protecting manufacturing test methods. Additional information about this litigation is set forth under Part II, Item 3 “Legal Proceedings” in this Quarterly Report on Form 10-Q. The uncertainty regarding the scope of the safe harbor may impair our ability to enforce certain of our patent rights and reduce the likelihood of enforcing certain of our patent rights to protect our innovations and our products. Accordingly, we do not know the degree of future enforceability for some of our proprietary rights.

The breadth of patent claims allowed in any patents issued to us or to others may be unclear. The allowance of broader claims may increase the incidence and cost of patent interference proceedings and/or opposition proceedings, and the risk of infringement litigation. On the other hand, the allowance of narrower claims may limit the value of our proprietary rights. Our issued patents may not contain claims sufficiently broad to protect us against third parties with similar technologies or products, or provide us with any competitive advantage. Moreover, once they have issued, our patents and any patent for which we have licensed or may license rights may be challenged, narrowed, invalidated or circumvented. If our patents are invalidated or otherwise limited, other companies will be better able to develop products that compete with ours, which could adversely affect our competitive business position, business prospects and financial condition.

We also rely on trade secrets, know-how and technology, which are not protected by patents, to maintain our competitive position. If any trade secret, know-how or other technology not protected by a patent were to be disclosed to or independently developed by a competitor, our business and financial condition could be materially adversely affected.

Third parties may allege that we are infringing their intellectual property rights, forcing us to expend substantial resources in resulting litigation, the outcome of which would be uncertain. Any unfavorable outcome of such litigation could have a material adverse effect on our business, financial position and results of operations.

The issuance of our own patents does not guarantee that we have the right to practice the patented inventions. Third parties may have blocking patents that could be used to prevent us from marketing our own patented product and practicing our own patented technology.

If any party asserts that we are infringing its intellectual property rights or that our creation or use of proprietary technology infringes upon its intellectual property rights, we might be forced to incur expenses to respond to and litigate the claims. Furthermore, we may be ordered to pay damages, potentially including treble damages, if we are found to have willfully infringed a party’s patent rights. In addition, if we are unsuccessful in litigation, or pending the outcome of litigation, a court could issue a temporary injunction or a permanent injunction preventing us from marketing and selling the patented drug or other technology for the life of the patent that we have been alleged or deemed to have infringed. Litigation concerning intellectual property and proprietary technologies is widespread and can be protracted and expensive, and can distract management and other key personnel from performing their duties for us.

Any legal action against us or our collaborators claiming damages and seeking to enjoin any activities, including commercial activities relating to the affected products, and processes could, in addition to subjecting us to potential liability for damages, require us or our collaborators to obtain a license in order to continue to manufacture or market the affected products and processes. Any license required under any patent may not be made available on commercially acceptable terms, if at all. In addition, some licenses may be non-exclusive, and therefore, our competitors may have access to the same technology licensed to us.

If we fail to obtain a required license or are unable to design around a patent, we may be unable to effectively market some of our technology and products, which could limit our ability to generate revenue or achieve profitability and possibly prevent us from generating revenue sufficient to sustain our operations.

If we remain involved in patent litigation or other proceedings to determine or enforce our intellectual property rights, we could incur substantial costs which could adversely affect our business.

We may need to continue to resort to litigation to enforce a patent issued to us or to determine the scope and validity of a third-party patent or other proprietary rights such as trade secrets in jurisdictions where we intend to market our products, including the United States, the European Union, and many other foreign jurisdictions. The cost to us of any litigation or other proceeding relating to determining the validity of intellectual property rights, even if resolved in our favor, could be substantial and could divert our management’s efforts. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they may have substantially greater resources. Moreover, the failure to obtain a favorable outcome in any litigation in a jurisdiction where there is a claim of patent

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infringement could significantly delay the marketing of our products in that particular jurisdiction. Counterclaims for damages and other relief may be triggered by such enforcement actions. The costs, uncertainties and counterclaims resulting from the initiation and continuation of any litigation could limit our ability to continue our operations.

We in-license a portion of our proprietary technologies and if we fail to comply with our obligations under any of the related agreements, we could lose license rights that are necessary to develop our product candidates.

We are a party to and rely on a number of in-license agreements with third parties, such as those with the Massachusetts Institute of Technology and Rockefeller University, which give us rights to intellectual property that may be necessary for certain parts of our business. In addition, we expect to enter into additional licenses in the future. Our current in-license arrangements impose various diligence, development, royalty and other obligations on us. If we breach our obligations with regard to our exclusive in-licenses, they could be converted to non-exclusive licenses or the agreements could be terminated, which would result in our being unable to develop, manufacture and sell products that are covered by the licensed technology.

Risks Relating to Our Dependence on Third Parties

The 2006 Sandoz Collaboration Agreement is important to our business. If Sandoz AG fails to adequately perform under this collaboration, or if we or Sandoz AG terminate all or a portion of this collaboration, the development and commercialization of some of our products and product candidates, including GLATOPA and M356, would be impacted, delayed or terminated and our business would be adversely affected.

Either we or Sandoz AG may terminate the 2006 Sandoz Collaboration Agreement for material uncured breaches or certain events of bankruptcy or insolvency by the other party. For some of the products, for any termination of the 2006 Sandoz Collaboration Agreement other than a termination by Sandoz AG due to our uncured breach or bankruptcy, or a termination by us alone due to the need for clinical trials, we will be granted an exclusive license under certain intellectual property of Sandoz AG to develop and commercialize the particular product. In that event, we would need to expand our internal capabilities or enter into another collaboration, which could cause significant delays that could prevent us from completing the development and commercialization of such product. For some products, if Sandoz AG terminates the 2006 Sandoz Collaboration Agreement due to our uncured breach or bankruptcy, or if there is a termination by us alone due to the need for clinical trials, Sandoz AG would retain the exclusive right to develop and commercialize the applicable product. In that event, we would no longer have any influence over the development or commercialization strategy of such product. In addition, for other products, if Sandoz AG terminates due to our uncured breach or bankruptcy, Sandoz AG retains a right to license certain of our intellectual property without the obligation to make any additional payments for such licenses. For certain products, if the 2006 Sandoz Collaboration Agreement is terminated other than due to our uncured breach or bankruptcy, neither party will have a license to the other party’s intellectual property. In that event, we would need to expand our internal capabilities or enter into another collaboration, which, if we were able to do so, could cause significant delays that could prevent us from completing the development and commercialization of such product. Any alternative collaboration could also be on less favorable terms to us. Accordingly, if the 2006 Sandoz Collaboration Agreement is terminated, our introduction of certain products may be significantly delayed, or our revenue may be significantly reduced, either of which could have a material adverse effect on our business.

Under our collaboration agreement, we are dependent upon Sandoz AG to successfully continue to commercialize GLATOPA and are significantly dependent on Sandoz AG to successfully commercialize M356. We do not fully control Sandoz AG’s commercialization activities or the resources it allocates to our products. While the 2006 Sandoz Collaboration Agreement contemplates joint decision making and alignment, our interests and Sandoz AG’s interests may differ or conflict from time-to-time or we may disagree with Sandoz AG’s level of effort or resource allocation. Sandoz AG may internally prioritize our products differently than we do or it may fail to allocate sufficient resources to effectively or optimally commercialize our products and alignment may only be achieved through dispute resolution. If these events were to occur, our business would be adversely affected.

The Baxalta Collaboration Agreement is important to our business. If we or Baxalta fail to adequately perform under the Agreement, or if we or Baxalta terminate the Agreement, the development and commercialization of our lead biosimilar, M923, would be delayed or terminated and our business would be adversely affected.

The Baxalta Collaboration Agreement may be terminated:

· by either party for breach by or bankruptcy of the other party;

· by Baxalta for its convenience;

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· by us in the event Baxalta does not exercise commercially reasonable efforts to commercialize M923 in the United States or other specified countries, provided, that we also have certain rights to directly commercialize M923, as opposed to terminating the Baxalta Collaboration Agreement, in event of such a breach by Baxalta; or

· by either party in the event there is a condition constituting force majeure for more than a certain consecutive number of days.

If the Baxalta Collaboration Agreement were terminated by Baxalta for convenience or if Baxalta elects to terminate the Baxalta Collaboration Agreement with respect to M923 in the specified time frame or if we terminate the Baxalta Collaboration Agreement for breach by Baxalta, while we would have the right to research, develop, manufacture or commercialize the terminated products or license a third party to do so, we would need to expand our internal capabilities or enter into another collaboration, which, if we were able to do so, could cause significant delays that could prevent us from commercializing M923. Any alternative collaboration could be on less favorable terms to us. In addition, we may need to seek additional financing to support the research, development and commercialization of any terminated products, or alternatively we may decide to discontinue any terminated products, which could have a material adverse effect on our business. If Baxalta terminates the Baxalta Collaboration Agreement due to our uncured breach, Baxalta would retain the exclusive right to commercialize M923 on a world-wide basis, subject to certain payment obligations to us as outlined in the Agreement. In addition, depending upon the timing of the termination, we would no longer have any influence over or input into the clinical development strategy or/and the commercialization strategy or/and the legal strategy of M923.

Under the Baxalta Collaboration Agreement, we are dependent upon Baxalta to successfully conduct clinical trials for, and if approved, commercialize M923. We do not control Baxalta’s administration of the clinical trials, commercialization activities or the resources it allocates to M923. Our interests and Baxalta’s interests may differ or conflict from time to time, or we may disagree with Baxalta’s level of effort or resource allocation. Baxalta may internally prioritize M923 differently than we do or it may not allocate sufficient resources to effectively or optimally administer clinical trials for, or commercialize, M923. If these events were to occur, our business would be adversely affected.

The Mylan Collaboration Agreement is important to our business. If we or Mylan fail to adequately perform under the Agreement, or if we or Mylan terminate the Agreement, the development and commercialization of one or more of our biosimilar candidates, including M834, could be delayed or terminated and our business would be adversely affected.

The Mylan Collaboration Agreement may be terminated by either party for breach by, or bankruptcy of, the other party; for its convenience; or for certain activities involving competing products or the challenge of certain patents. Other than in the case of a termination for convenience, the terminating party shall have the right to continue the development, manufacture and commercialization of the terminated products in the terminated countries. In the case of a termination for convenience, the other party shall have the right to continue. If a termination occurs, the licenses granted to the non-continuing party for the applicable product will terminate for the terminated country. Subject to certain terms and conditions, the party that has the right to continue the development or commercialization of a given product candidate may retain royalty-bearing licenses to certain intellectual property rights, and rights to certain data, for the continued development and sale of the applicable product in the country or countries for which termination applies.

If the Mylan Collaboration Agreement was terminated and we had the right to continue the development and commercialization of one or more terminated products, to fully exercise that right, we would need to expand our internal capabilities or enter into another collaboration, which, if we were able to do so, could cause significant delays that could prevent us from commercializing those products. Any alternative collaboration could be on less favorable terms to us. In addition, we may need to seek additional financing to support the development and commercialization of any terminated products, or alternatively we may decide to discontinue one or more terminated products, which could have a material adverse effect on our business. If the Mylan Collaboration Agreement was terminated and Mylan had the right to continue the development and commercialization of one or more terminated products, we would have no influence or input into those activities.

Under the Mylan Collaboration Agreement, we are dependent upon Mylan to successfully perform its responsibilities and activities, including conducting clinical trials for certain products and leading the commercialization of products. We do not control Mylan’s execution of its responsibilities, including commercialization activities, or the resources it allocates to our products. Our interests and Mylan’s interests may differ or conflict from time to time, or we may disagree with Mylan’s level of effort or resource allocation. Mylan may internally prioritize our products differently than we do or it may not allocate sufficient resources to effectively or optimally execute its responsibilities or activities. If these events were to occur, our business would be adversely affected.

We and our collaborative partners depend on third parties for the manufacture of products. If we encounter difficulties in our supply or manufacturing arrangements, our business may be materially adversely affected.

We have a limited number of personnel with experience in, and we do not own facilities for, manufacturing products. In addition, we do not have, and do not intend to develop, the ability to manufacture material for our clinical trials or at commercial scale. To develop our product candidates, apply for regulatory approvals and commercialize any products, we or our collaborative partners need to contract for or otherwise arrange for the necessary manufacturing facilities and capabilities. In order to generate revenue from the sales of Enoxaparin Sodium Injection and GLATOPA, sufficient quantities of such product must also be produced in order to satisfy demand. If these contract manufacturers are

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unable to manufacture sufficient quantities of product, comply with regulatory requirements, or breach or terminate their manufacturing arrangements with us, the development and commercialization of the affected products or drug candidates could be delayed, which could have a material adverse effect on our business. In addition, any change in these manufacturers could be costly because the commercial terms of any new arrangement could be less favorable and the expenses relating to the transfer of necessary technology and processes could be significant.

We have relied upon third parties to produce material for nonclinical and clinical studies and may continue to do so in the future. We cannot be certain that we will be able to obtain and/or maintain long-term supply and supply arrangements of those materials on acceptable terms, if at all. If we are unable to arrange for third-party manufacturing, or to do so on commercially reasonable terms, we may not be able to complete development of our products or market them.

In addition, the FDA and other regulatory authorities require that our products be manufactured according to current good manufacturing practices, or cGMP, regulations and that proper procedures are implemented to assure the quality of our sourcing of raw materials and the manufacture of our products. Any failure by us, our collaborative partners or our third-party manufacturers to comply with cGMP, and/or our failure to scale-up our manufacturing processes could lead to a delay in, or failure to obtain, regulatory approval. In addition, such failure could be the basis for action by the FDA to withdraw approvals for drug candidates previously granted to us and for other regulatory action, including product recall or seizure, fines, imposition of operating restrictions, total or partial suspension of production or injunctions. To the extent we rely on a third-party manufacturer, the risk of non-compliance with cGMPs may be greater and the ability to effect corrective actions for any such noncompliance may be compromised or delayed.

If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate product revenue.

We do not have a sales organization and have no experience as a company in the sale, marketing or distribution of pharmaceutical products. There are risks involved with establishing our own sales and marketing capabilities, as well as entering into arrangements with third parties to perform these services. For example, developing a sales force is expensive and time consuming and could delay any product launch. In addition, to the extent that we enter into arrangements with third parties to perform sales, marketing or distribution services, we will have less control over sales of our products and our future revenue would depend heavily on the success of the efforts of these third parties.

A significant change in the business operations of, a change in senior executive management within, or a change in control of Sandoz, Baxalta or Mylan, or any future collaboration partners or third party manufacturers could have a negative impact on our business operations.

Since many of our product candidates are developed under collaborations with third parties, we do not have sole decision making authority with respect to commercialization or development of those product candidates. We have built relationships and work collaboratively with our third party collaborators and manufacturers to ensure the success of our development and commercialization efforts. A significant change in the senior management team, or business operations, including, a change in control or internal corporate restructuring, of any of our collaboration partners or third party manufacturers could result in delayed timelines on our products. In addition, we may have to re-establish working relationships and familiarize new counterparts with our products and business. Any such change may result in the collaboration partner or third party manufacturer internally re-prioritizing our programs or decreasing resources allocated to support our programs. For example, in January 2016, Baxalta and Shire plc announced an agreement under which Shire will combine with Baxalta, subject to shareholder and regulatory approvals. Following such combination, we will become dependent on Shire plc to allocate resources for future development and commercialization of M923, and there could be changes or delays in the timing of the M923 program in connection with the integration of Baxalta and Shire plc. Similar changes with respect to any of our other collaborators may negatively impact our business operations.

General Company Related Risks

Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.

Provisions in our certificate of incorporation and our by-laws may delay or prevent an acquisition of us or a change in our management. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Because our board of directors is responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team. These provisions include:

· a classified board of directors;

· a prohibition on actions by our stockholders by written consent; and

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· limitations on the removal of directors.

Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner. Finally, these provisions establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon at stockholder meetings. These provisions would apply even if the offer may be considered beneficial by some stockholders.

Our stock price may be volatile, and purchasers of our common stock could incur substantial losses.

The stock market in general and the market prices for securities of biotechnology companies in particular have experienced extreme volatility that often has been unrelated or disproportionate to the operating performance of these companies. The trading price of our common stock has been, and is likely to continue to be, volatile. Furthermore, our stock price could be subject to wide fluctuations in response to a variety of factors, including the following:

· delays in achievement of, or failure to achieve, program milestones that are associated with the valuation of our company or significant milestone revenue;

· failure of GLATOPA to sustain profitable sales or market share that meet expectations of securities analysts;

· other adverse FDA decisions relating to our GLATOPA or M356 programs, including an FDA decision to require additional data, including requiring clinical trials, as a condition to M356 ANDA approval;

· litigation involving our company or our general industry or both, including litigation pertaining to the launch of our, our collaborative partners’ or our competitors’ products;

· a decision in favor of, or against, Amphastar in our patent litigation suits, a settlement related to any case; or a decision in favor of Amphastar or others in the anti-trust suits filed against us;

· announcements by other companies regarding the status of their ANDAs for generic versions of COPAXONE;

· FDA approval of other companies’ ANDAs for generic versions of COPAXONE;

· marketing and/or launch of other companies’ generic versions of COPAXONE;

· adverse FDA decisions regarding the development requirements for one of our biosimilar development candidates or failure of our other product applications to meet the requirements for regulatory review and/or approval;

· results or delays in our or our competitors’ clinical trials or regulatory filings;

· enactment of legislation that repeals the law enacting the biosimilar regulatory approval pathway or amends the law in a manner that is adverse to our biosimilar development strategy;

· failure to demonstrate therapeutic equivalence, biosimilarity or interchangeability with respect to our technology-enabled generic product candidates such as M356 or biosimilars such as M923 or M834;

· demonstration of or failure to demonstrate the safety and efficacy for our novel product candidates;

· our inability to manufacture any products in conformance with cGMP or in sufficient quantities to meet the requirements for the commercial sale of the product or to meet market demand;

· failure of any of our product candidates, if approved, to achieve commercial success;

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· the discovery of unexpected or increased incidence in patients’ adverse reactions to the use of our products or product candidates or indications of other safety concerns;

· developments or disputes concerning our patents or other proprietary rights;

· changes in estimates of our financial results or recommendations by securities analysts;

· termination of any of our product development and commercialization collaborations;

· significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

· investors’ general perception of our company, our products, the economy and general market conditions;

· rapid or disorderly sales of stock by holders of significant amounts of our stock; or

· significant fluctuations in the price of securities generally or biotech company securities specifically.

If any of these factors causes an adverse effect on our business, results of operations or financial condition, the price of our common stock could fall and investors may not be able to sell their common stock at or above their respective purchase prices.

We could be subject to class action litigation due to stock price volatility, which, if it occurs, will distract our management and could result in substantial costs or large judgments against us.

The stock market in general has recently experienced extreme price and volume fluctuations. In addition, the market prices of securities of companies in the biotechnology industry have been extremely volatile and have experienced fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. These fluctuations could adversely affect the market price of our common stock. In the past, securities class action litigation has often been brought against companies following periods of volatility in the market prices of their securities. We may be the target of similar litigation in the future. Securities litigation could result in substantial costs and divert our management’s attention and resources, which could cause serious harm to our business, operating results and financial condition.

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Item 6. EXHIBITS

			Incorporated by Reference to
Exhibit Number	Description	Form or Schedule	Exhibit No.	Filing Date with SEC	SEC File Number
*10.1	Non-Employee Director Compensation Summary
*+10.2	Collaboration Agreement, by and between Momenta Pharmaceuticals, Inc. and Mylan Ireland Limited, executed as of January 8, 2016.
*31.1	Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
*31.2	Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
**32.1	Certifications of Chief Executive Officer and Chief Financial Officer 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 Calculation Linkbase Document.
*101.LAB	XBRL Taxonomy Label Linkbase Document.
*101.PRE	XBRL Taxonomy Presentation Linkbase Document.
*101.DEF	XBRL Taxonomy Extension Definition Linkbase Document.
*101.REF	XBRL Taxonomy Reference Linkbase Document.

* Filed herewith.

** Furnished herewith.

+ Confidential treatment has been requested as to certain portions, which portions have been omitted and filed separately with the Securities and Exchange Commission.

The following materials from the Registrant’s Quarterly Report on Form 10-Q for the period ended March 31, 2016, formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Balance Sheets at March 31, 2016 and December 31, 2015, (ii) the Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 2016 and 2015, (iii) the Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2016 and 2015, and (iv) Notes to Unaudited, Condensed Consolidated Financial Statements.

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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.

	Momenta Pharmaceuticals, Inc.
Date: May 6, 2016
	By:	/s/ Craig A. Wheeler
		Craig A. Wheeler, President and Chief Executive Officer
		(Principal Executive Officer)
Date: May 6, 2016

	By:	/s/ Richard P. Shea
		Richard P. Shea, Senior Vice President and Chief Financial Officer
		(Principal Financial and Accounting Officer)

Exhibit 10.1

Non-Employee Director Compensation Summary

The following is a summary of the compensation program for non-employee directors of Momenta Pharmaceuticals, Inc. (the “Company”):

Stock Option Grant Upon Initial Appointment or Election

Each new non-employee director receives an option to purchase up to 33,000 shares of the Company’s common stock upon his or her initial election or appointment to the Board of Directors (the “Board”), with 1/3 of such option to vest on the first anniversary of the date of grant and an additional 8 1/3% to vest at the end of every three-month period thereafter, subject to the director’s continued service to the Company. Each option is granted pursuant to, and subject to the terms of, the Company’s incentive award plan and a stock option award agreement in substantially the form of the Company’s standard stock option agreement approved by the Board.

Annual Option and Restricted Stock Grant

Each non-employee director who served as a director in the previous year receives an option to purchase up to 11,000 shares of the Company’s common stock on the date of the scheduled meeting of the Board coinciding with each annual meeting of the Company’s stockholders, with such option to vest in full on the first anniversary of the date of grant, subject to the director’s continued service to the Company. Each option is granted pursuant to, and subject to the terms of, the Company’s incentive award plan and a stock option award agreement in substantially the form of the Company’s standard stock option agreement approved by the Board.

Each non-employee director who served as a director in the previous year receives 5,500 restricted shares of common stock of the Company on the date of the scheduled meeting of the Board coinciding with each annual meeting of the Company’s stockholders, with 100% of the shares to vest and become free from forfeiture and transfer restrictions on the first anniversary of date of grant, subject to the director’s continued service to the Company. The shares of restricted common stock are granted pursuant to, and subject to the terms of, the Company’s incentive award plan and a restricted stock award agreement in substantially the form of the Company’s standard restricted stock award agreement approved by the Board.

Payment of Retainer Fee; Reimbursement of Travel and Other Expenses

Each non-employee director is entitled to receive an annual retainer for his or her service on the Board, as well as additional fees for committee service, as follows:

Position		Fees
Annual Retainer		$40,000
Non-Employee Chairman of the Board		$30,000
Audit Committee Chair		$20,000
Audit Committee Members (other than the Chair)		$10,000
Compensation Committee Chair		$15,000
Compensation Committee Members (other than the Chair)		$7,500
Nominating and Corporate Governance Committee Chair		$12,000
Nominating and Corporate Governance Committee Members (other than the Chair)		$6,000
Science Committee Chair		$10,000
Science Committee Members		$7,500
Additional Payments to Science Committee Chair and Members		$3,000 for each all day session attended (up to a maximum of $15,000 per year) that is in addition to the standard quarterly meetings of the Scientific Committee

All retainer amounts are paid quarterly in arrears during the fiscal year. Non-employee directors also receive reimbursement for reasonable travel and other expenses in connection with attending Board meetings.

Exhibit 10.2

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Execution Copy

COLLABORATION AGREEMENT

BY AND BETWEEN

MOMENTA PHARMACEUTICALS, INC.

AND

MYLAN IRELAND LIMITED,

DATED AS

OF JANUARY 8, 2016

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Article 1. DEFINITIONS	3

Article 2. DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION OF THE PRODUCTS	18

Article 3. GOVERNANCE	24

Article 4. FINANCIAL TERMS	31

Article 5. INTELLECTUAL PROPERTY AND LITIGATION	38

Article 6. LICENSES AND EXCLUSIVITY	43

Article 7. CONFIDENTIAL INFORMATION	46

Article 8. INDEMNIFICATION AND LIMITATION OF LIABILITY	48

Article 9. EXPORT	50

Article 10. TERM AND TERMINATION	51

Article 11. REPRESENTATIONS, WARRANTIES AND COVENANTS	58

Article 12. MISCELLANEOUS	62

COLLABORATION AGREEMENT

This Collaboration Agreement (the “Agreement”), executed as of January 8, 2016 (the “Execution Date”), is made by and between Momenta Pharmaceuticals, Inc., a Delaware corporation (“Momenta”), with a principal place of business at 675 West Kendall Street, Cambridge, Massachusetts 02142, and Mylan Ireland Limited, a limited company organized under the laws of Ireland (“Mylan”), with a principal place of business at South Bank House, Barrow Street, 6th Floor, Dublin 4, Ireland. Momenta and Mylan may each be referred to individually as a “Party” or, collectively, the “Parties”.

RECITALS

The Parties desire to collaborate with respect to the development, manufacture and commercialization of a portfolio of biosimilar versions of certain reference brand biologic products, as described below.

In consideration of the premises set forth above and the mutual covenants contained herein, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Momenta and Mylan agree as follows:

ARTICLE 1.
DEFINITIONS

The capitalized terms used in this Agreement (other than the headings of the Sections or Articles) have the following meanings set forth in this Article 1, or, if not listed in this Article 1, the meanings as designated in the text of this Agreement.

1.1 “Abatacept Innovator” means Bristol-Myers Squibb Company and [***].

1.2 “Accounting Standards” means GAAP, consistently applied by the applicable Party.

1.3 “Additional Clinical Trial” means a controlled clinical trial of a Product in human patients to generate safety, efficacy or clinical immunogenicity data to demonstrate that such Product is highly similar to its Reference Product and to demonstrate safety, purity, and potency of such Product, in the proposed therapeutic indication, which information is sufficient to support the filing for Regulatory Approval under Section 351(k) of the PHS Act, or corresponding laws or their implementing regulations in other countries within the Territory. For clarity, an Additional Clinical Trial may be conducted using a single dose or regimen or multiple doses or regimens, as appropriate, and such Additional Clinical Trial may be conducted at multiple centers. The Additional Clinical Trial shall be designed to be a pivotal study or, when appropriate outside the United States, a Phase 3 clinical trial, for such Product.

1.4 “Additional Development Activity” has the meaning set forth in Section 2.2(b).

1.5 “Affiliate” means, with respect to a Person any Person that controls, is controlled by, or is under common control with such Person, for so long as such control exists. For purposes of the foregoing sentence, “control” means: (a) to possess, directly or indirectly, the

power to direct affirmatively the management and policies of such Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance; (b) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors; or (c) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such non-corporate entities, or in each case (a) and (b) such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction.

1.6 “[***] Innovator” means [***] and [***] with respect to [***], and [***].

1.7 “Allocable Legal Expense Share” means with respect to each Product, fifty percent (50%) for Momenta and fifty percent (50%) for Mylan.

1.8 “Applicable Law” means all applicable provisions of any and all federal, national, state, provincial, and local statutes, laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, injunctions, awards, judgments, permits and licenses of or from any governmental authorities (including Regulatory Authorities) relating to or governing a Party’s obligations and rights under this Agreement.

1.9 “Approval Batch” means any validation, confirmation or scale-up batch of Product manufactured in support of Regulatory Approval.

1.10 “Biosimilar” means, with respect to a reference brand biologic product, a [***] that is: (a) [***]; and (b) [***]; and (c) [***].

1.11 “Biological Entity” means each of: (a) the fusion protein abatacept; (b) the [***]; (c) the [***]; (d) the [***]; (e) the [***]; and (f) the [***], in each case [***], along with [***].

1.12 “BLA” means a Biologics License Application filed pursuant to the requirements of the FDA under Section 351(k) of the PHS Act and 12 C.F.R., Section 601.2, to obtain Regulatory Approval for a Product in the United States, or the equivalent application or filing in another country (as applicable).

1.13 “BPCI Act” means the Biologics Price Competition and Innovation Act of 2009 within the Patient Protection and Affordable Care Act, signed into law in March 2010, and as may be subsequently amended.

1.14 “Business Day” means any day other than a: (a) Saturday or Sunday; (b) day that is a recognized national holiday in the U.S.; or (c) day that commercial banks are authorized to close under the Applicable Laws of, or are in fact closed in, the Commonwealth of Massachusetts or State of New York.

1.15 “Calendar Quarter” means each of the three (3) month periods ending March 31, June 30, September 30 and December 31; provided, however, that: (a) the first Calendar Quarter of the Term shall extend from the Effective Date to the end of the first complete Calendar Quarter thereafter; and (b) the last Calendar Quarter shall extend from the beginning of the Calendar Quarter in which this Agreement expires or terminates until the effective date of such expiration or termination.

1.16 “Calendar Year” means: (a) for the first Calendar Year of the Term, the period beginning on the Effective Date and ending on December 31, 2016; (b) for each Calendar Year of the Term thereafter, each successive period beginning on January 1 and ending twelve (12) consecutive calendar months later on December 31; and (c) for the last Calendar Year of the Term, the period beginning on January 1 of the Calendar Year in which the Agreement expires or terminates and ending on the effective date of expiration or termination of this Agreement.

1.17 “Claims” means, collectively, any and all Third Party demands, claims, actions and proceedings (whether criminal or civil, in contract, tort or otherwise).

1.18 “Clinical Development” means any and all Development activities to be conducted in humans related to or in furtherance of Regulatory Approval, including all clinical trials and any such post-approval regulatory commitments, or Post-Approval Clinical Trials. The Clinical Development activities to be performed as part of the Collaboration shall be as described in the applicable Product Work Plan.

1.19 “Collaboration” means the Development, Manufacturing and Commercialization of, and the conduct of the relevant Legal Activities with respect to, the Products in the relevant countries in the Territory, under this Agreement as described herein and the applicable Product Work Plans.

1.20 “Collaboration Intellectual Property” means all Collaboration Know-How and Collaboration Patent Rights. Collaboration Intellectual Property shall exclude Momenta Intellectual Property and Mylan Intellectual Property.

1.21 “Collaboration Know-How” means Know-How [***]. Collaboration Know-How shall exclude [***].

1.22 “Collaboration Patent Rights” means Patent Rights [***]. Collaboration Patent Rights shall exclude [***].

1.23 “Commercialize” “Commercialization” and “Commercialization Activities” means all activities of using, marketing, promoting, distributing, importing, offering for sale or selling a Product related to the Launch and commercialization of such Product in the respective countries of the Territory. Such Commercialization Activities may include activities with respect to a Product that are directed to: [***]. For avoidance of doubt, [***] above sets forth examples of activities that may constitute “Commercialization Activities” rather than a list of activities required to be performed by a Party or limiting the activities that would constitute Commercialization. The Commercialization Activities to be performed as part of the Collaboration for any specific Product shall be as described in the applicable Commercialization Plan.

1.24 “Commercialization Expenses” means, with respect to a Product, the [***] costs [***] related to Commercialization and [***], in connection with Commercialization of such Product [***], as determined [***]. For clarity, a Product’s Commercialization Expenses excludes the [***] for such Product and includes the [***] costs [***], and the [***]. Commercialization Expenses also include [***] associated with [***] and other [***].

1.25 “Commercialization Plan” shall be a component of each Product Work Plan as further described at Section 2.1(c) herein.

1.26 “Commercial Scale” means the scale of a chemical or biological process for the Manufacture of a Product in sufficient quantities to support the projected supply requirements for the marketed Product as of the First Commercial Sale of such Product. Commercial Scale, as it relates to a Product, shall, as appropriate, be further defined in the applicable Product Work Plan.

1.27 “Commercially Reasonable Efforts” means, with respect to the performing Party, the carrying out of obligations of such Party in a diligent and expeditious manner as is commonly practiced in the pharmaceutical industry, including the allocation of a commercially reasonable level of personnel and financial resources, consistent with (and not materially less than) such level of resources and efforts that an established pharmaceutical company typically devotes to products of similar market potential at a similar stage of development or commercialization in its product lifecycle, [***].

1.28 “Competing Product” means, with respect to any Product: (a) [***]; (b) [***]. For example, a Competing Product [***] M834 would be [***] Orencia®, [***] Orencia®, [***] protein [***] abatacept.

1.29 [***] means [***], which may include: (a) [***]; (b) [***]; (c) [***]; or (d) [***].

1.30 “Confidential Information” means: (a) all proprietary information and materials, patentable or otherwise, of a Party which is disclosed by or on behalf of such Party to the other Party or its representatives pursuant to and in contemplation of this Agreement, including, without limitation, biological or chemical substances, formulations, techniques, methodology, equipment, data, reports, Know-How, sources of supply, patent positioning, business plans and financial information; and (b) any other information designated by the disclosing Party to the other Party in writing as confidential or proprietary, whether or not related to making, using or selling a Product. Notwithstanding the foregoing, the term ‘Confidential Information’ shall not include information: (w) which is or becomes generally available to the public other than as a result of disclosure thereof by the receiving Party; (x) which is lawfully received by the receiving Party on a non-confidential basis from a Third Party that is not, to the receiving Party’s knowledge, itself under any obligation of confidentiality or nondisclosure to the disclosing Party or any other Person with respect to such information; (y) which is already known to the receiving Party at the time of disclosure by the disclosing Party; or (z) which can be shown by the receiving Party to have been independently developed by the receiving Party without use of or reference to the disclosing Party’s Confidential Information.

1.31 “Control” means, with respect to any Patent Rights or any item of Know-How, the possession, whether by ownership or license (other than licensed by one Party to the other Party pursuant to this Agreement), by a Party or any of its Affiliates of the ability to grant access, a license or a sublicense as provided in this Agreement under such item or right without: (a) violating the terms of any agreement or other arrangement with, or any legal rights of, any Third Party; (b) violating the terms of any agreement to which such Party or its Affiliate is a party; or (c) requiring the consent of any Third Party. For clarity, any such Patent Rights or item of Know-How [***].

1.32 “Cost of Goods Sold” or “COGS” means: (a) with respect to Product that is Manufactured by a Party or its Affiliates, the Manufacturing Cost of such Product; and (b) with respect to Product purchased by a Party or its Affiliates from a Third Party, such Party or its Affiliate’s [***] cost of acquisition [***], together in the case of (a) and (b) with: (i) [***] (ii) [***], and together in the case of (b) [***], including [***]. For clarity, COGS shall include [***]. If [***].

1.33 “Covers” means: (a) with respect to Know-How, that the making, using, selling or offering for sale of a given molecule, product, or item would require the use of such Know-How; and (b) with respect to Patent Rights, that the making, using, selling, offering for sale, or importation of a given molecule, product, or item would infringe a Valid Claim of such Patent Rights (in the absence of ownership of, or a license under, such Patent Rights).

1.34 “[***] Innovator” means [***] and [***] or [***].

1.35 “Develop”, “Development” and “Development Activities” means with respect to a Product, all activities either related to or in furtherance of the creation or scientific or technical improvement of such Product, or that are necessary or useful to obtain Regulatory Approval of such Product, whether such activities are conducted prior to the filing of an application for Regulatory Approval of such Product in any country in the Territory or thereafter. Development Activities may include: [***]. For avoidance of doubt, [***] above set forth examples of activities that would constitute “Development Activities” rather than a list of activities required to be performed by a Party or limiting activities to be performed by a Party. The Development Activities to be performed as part of the Collaboration for any specific Product shall be as described in the applicable Product Work Plan.

1.36 “Development Expenses” means, with respect to a Product, the costs [***], including [***] in connection with the Development of such Product in accordance with the relevant Product Work Plan, as determined [***]. For clarity, Development Expenses shall include all [***] as well as [***].

1.37 “Divest” or “Divestiture” means, with respect to any Competing Product: (a) the sale, exclusive license or other transfer of all of the right, title and interest in and to such Competing Product in the applicable country(ies) in the Territory, including all technology, intellectual property and other assets relating solely thereto, to an independent Third Party, without the retention or reservation of any rights, license or interest (other than solely an economic interest and, in the event of a termination, customary residual rights) in such Competing Product with respect to the applicable country(ies) in the Territory; or (b) the shutdown of activities related to the Competing Product in the applicable country(ies) in the Territory such that no technology, intellectual property or other asset relating thereto is used by the applicable Party or its Affiliates and delivery of written confirmation from such Party to the other Party that the Divesting Party and its Affiliates covenant not to use any technology, intellectual property and assets solely relating to such Competing Product in the applicable country(ies) in the Territory during the Term.

1.38 “Dollars” or “$” means the legal tender of the United States.

1.39 “[***] Innovator” means [***] and [***] and [***].

1.40 “Effective Date” means the HSR Clearance Date, as defined in Section 12.12.

1.41 “EMA” or “European Medicines Agency” means the European Union agency for the evaluation of medicinal products, or any successor entity thereto.

1.42 “Enforcement Litigation” shall have the meaning set forth at Section 5.4(b).

1.43 “EU” means the European Union.

1.44 “Fault” means, with respect to a Party: (a) the breach of this Agreement by such Party, including a breach of a Party’s representations or warranties under Article 11; (b) the violation of Applicable Law in the performance of the Collaboration; or (c) the (i) negligence or gross negligence; (ii) willful misconduct; (iii) intentional misrepresentation; (iv) recklessness; or (v) fraud of or by such Party, in each case ((i) - (v)) in the Development or Manufacture for, or Commercialization in, the Territory of a Product or otherwise in the performance of any other rights or obligations under this Agreement.

1.45 “FDA” or “Food and Drug Administration” means the U.S. Food and Drug Administration, or any successor entity thereto.

1.46 “Field” means use for all therapeutic indications in humans.

1.47 “Final Legal Clearance” means with respect to [***]: (a) [***] (b) [***] or (c) [***] provided however that [***].

1.48 “First Commercial Sale” means, with respect to any Product, the first sale of such Product by a Party, its Sublicensee or any of their respective Affiliates to a Third Party following receipt of Regulatory Approval of such Product in the country of sale.

1.49 “FTE” means the equivalent of the work of one (1) employee full-time for one (1) year (consisting of a total of [***] per year, or such other number as may be agreed by the JSC) on or directly related to the Collaboration. Any individual who devotes less than [***] per year (or such other number as may be agreed by the JSC) shall be treated as an FTE on a pro-rata basis upon the actual number of hours worked divided by [***] (or such other number as may be agreed by the JSC). Unless modified by the JSC, the [***].

1.50 “FTE Costs” means the actual fully burdened cost per FTE on an annual basis [***].

1.51 “GAAP” means U.S. Generally Accepted Accounting Principles.

1.52 “GMP” or “Good Manufacturing Practice” means the current good manufacturing practice regulations of the FDA, including as described in the U.S. Code of Federal Regulations, Parts 210, 211, 601, and 606, or any applicable corresponding foreign regulations or their respective successor regulations.

1.53 “Hold Separate Transaction” means any “hold separate” transaction (whether through the establishment of a trust or otherwise) involving the proposed sale of a Competing

Product in the applicable country(ies) in the Territory pursuant to an agreement with any governmental authority responsible for antitrust laws.

1.54 “IND” means: (a) an Investigational New Drug Application as defined in the United States Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder by the FDA, including 21 C.F.R., part 312; or (b) a Clinical Trial Application or equivalent application in the EU, the filing of which is necessary to commence clinical testing of a pharmaceutical product in humans in a particular jurisdiction.

1.55 “IND Acceptance” means, with respect to a Product, the earlier to occur of the date that: (a) written notice of a waiver of, or exemption from, the need to file an IND is received by a Party from the applicable Regulatory Authority and such waiver or exemption becomes effective, in each case either in the U.S. or the EU; or (b) authorization is obtained from the applicable Regulatory Authority in the U.S. or the EU to initiate dosing in humans, based on such Regulatory Authority’s review of analytical data comparing such Product to the Reference Product, which in the U.S. means: (i) thirty (30) days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold; or (ii) on written notification by FDA that the clinical investigations in the IND may begin. For avoidance of doubt, the written notice referred to in subsection (a) above may be in the form of a letter from the relevant Regulatory Authority approving the development plan of the Parties that does not require human clinical trials as adequate to support Regulatory Approval of the applicable Product or an actual written waiver of an IND.

1.56 “Initial Clinical Trial” means a human clinical trial of a Product (as required by the applicable Regulatory Authority) conducted to generate pharmacokinetic and pharmacodynamic (if relevant pharmacodynamic measures exist) data that is comparative to the applicable Reference Product, for purposes of supporting an application for Regulatory Approval under Section 351(k) of the PHS Act, or equivalent in other countries within the Territory. The Initial Clinical Trial shall be designed to be a Phase 1 clinical trial for such Product but may also include additional features that could facilitate a waiver or targeting of the Additional Clinical Trial.

1.57 “Initial Press Releases” shall have the meaning set forth at Section 7.2 herein.

1.58 “Innovator” means the Abatacept Innovator, the [***] Innovator, the [***] Innovator, the [***] Innovator, the [***] Innovator, or the [***] Innovator, as applicable.

1.59 “[***] Innovator” means [***] and [***].

1.60 “Joint Steering Committee” or “JSC” shall have the meaning set forth in Section 3.1.

1.61 “Know-How” means information and materials, including, without limitation, ideas, concepts, discoveries, inventions, developments, improvements, know-how, expertise, trade secrets, designs, devices, equipment, process conditions, physical materials (including chemical or biological materials), production processes and designs, specifications, computer programs, formulas, techniques, methods, procedures, assay systems and applications, experimental results, data (including, without limitation, analytical, toxicological,

pharmacological, clinical, bioequivalence, and stability data), documentation, and reports, whether patentable or otherwise. For clarity, Know-How excludes Patent Rights.

1.62 “Launch” means, with respect to any Product, to make (or the making of, as context requires) the First Commercial Sale of such Product.

1.63 “Legal Activities” means legal work and advice relating to the Collaboration including: (a) [***]; (b) [***]; (c) [***]; (d) [***]; (e) [***]; and (f) [***].

1.64 “Legal Expenses” means, with respect to a Product, the costs [***], including [***], in connection with Legal Activities for such Product conducted pursuant to this Agreement. For avoidance of doubt, Legal Expenses includes the costs of [***].

1.65 “Losses” means any and all liabilities, penalties, damages costs, fines, and expenses [***].

1.66 “Major Country” means each of the [***].

1.67 “Manufacture,” “Manufacturing” and “Manufacturing Activities” means, with respect to a Product, all activities involved in the production, storing, handling, packaging, labeling and distribution of Product to be Developed or Commercialized under this Agreement. Such Manufacturing Activities may include: (a) creation and design of the Product packaging; (b) the creation and implementation of a commercial inventory and Product supply chain distribution strategy; (c) the manufacture of clinical and commercial inventory for the Product; (d) the manufacture of a delivery device for the Product; (e) the manufacture of the packaging for the Product; (f) quality control and quality assurance of the Product; (g) release of the Product; and (h) the distribution, delivery and storage of the Product. For avoidance of doubt, (a) through (h) above sets forth examples of activities that would constitute “Manufacturing Activities” rather than a list of activities required to be performed by a Party. The Manufacturing Activities to be performed as part of the Collaboration for any specific Product shall be as described in the applicable Product Work Plan.

1.68 “Manufacturing Cost” means, with respect to a Product, the [***], for the Manufacture of such Product [***], which costs may include:

[***].

For clarity, Manufacturing Cost shall exclude [***].

1.69 “Momenta Improvement(s)” means any Patent Rights or Know-How [***]. For clarity, any such Patent Rights or Know-How [***].

1.70 “Momenta Intellectual Property” means all Momenta Know-How, Momenta Patent Rights and Momenta Improvements.

1.71 “Momenta Know-How” means all Know-How that is [***]: (a) [***]; or (b) is [***].

1.72 “Momenta Patent Rights” means all Patent Rights that are [***]: (a) [***]; or (b) [***].

1.73 “Mylan Improvement(s)” means any Patent Rights or Know-How [***]. For clarity, any such Patent Rights or Know-How [***].

1.74 “Mylan Intellectual Property” means all Mylan Know-How, Mylan Patent Rights, and Mylan Improvements.

1.75 “Mylan Know-How” means all Know-How that is [***]: (a) [***]; or (b) [***].

1.76 “Mylan Patent Rights” means all Patent Rights that are [***]: (a) [***] (b) [***].

[***] “Net Sales” means, with respect to a Product, the gross amount invoiced for the sale of such Product by a Party or its Affiliates (or, solely in the case of determining Net Sales when a royalty is owed on Net Sales of such Product pursuant to Section 10.6(a), 10.6(b) or 12.3(c), its Sublicensee) (“Selling Party”) to a Third Party (whether an end user, distributor, Sublicensee or otherwise), less the following calculated in accordance with Accounting Standards: [***].

1.78 “Other Collaboration Litigation” means all: (a) [***] and litigation process contemplated by Section 5.5(a) and corresponding laws of other countries; (b) [***]; (c) [***]; and (d) patent infringement litigation filed by Third Parties against Mylan or Momenta relating to the Products and other litigation matters contemplated by Section 5.5(b), including [***].

1.79 “Patent Activities” means all activities of the Parties with respect to [***].

1.80 “Patent Rights” means all: (a) U.S. patents (including all reissues, substitutions, confirmations, re-registrations, re-examinations, validations, extensions, renewals or restorations); (b) U.S. patent applications (including all provisional applications, non-provisional application, continuations, continuations-in-part, divisional, continued prosecution applications, reissue applications or re-examination applications); and (c) all non-U.S. or international counterparts of any of the foregoing, or as applicable portions thereof or individual claims therein.

1.81 “Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, or any other entity not specifically listed herein.

1.82 “PHS Act” means the Public Health Services Act (Title 42, U.S.C., Chapter 6A). As used herein the PHS Act shall refer, more specifically, to 42 USC § 262, which governs the regulation of biological products.

1.83 “Post-Approval Clinical Trial” means a clinical trial of a Product that is completed after receipt of Regulatory Approval of such Product and that is not required by the applicable Regulatory Authority as a condition to receiving such Regulatory Approval. A Post-Approval Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic

studies, and investigator-sponsored clinical trials studying Product that are approved by the JSC and that otherwise fit the foregoing definition.

1.84 “Product(s)” means any and all biological products [***] incorporating a Biological Entity [***], including each of the following Biosimilars: (a) Momenta’s development compound referred to as “M834”, a fusion protein for which abatacept (the product known as Orencia®) is the reference brand biologic; (b) Momenta’s development compound referred to as [***], a [***] for which [***] (the product known as [***] is the reference brand biologic; (c) Momenta’s development compound referred to as [***], a [***] for which [***] (the product known as [***] is the reference brand biologic; (d) Momenta’s development compound referred to as [***], a [***] for which [***] (the product known as [***] is the reference brand biologic; (e) Momenta’s development compound referred to as [***], a [***] for which [***] (the product known as [***] is the reference brand biologic; and (f) Momenta’s development compound referred to as [***], a [***] for which [***] (the product known as [***] or [***] is the reference brand biologic. At any time prior to the applicable Continuation Decision, each Product shall be eligible for substitution in accordance with Section 2.6(b).

1.85 “Product Work Plan” means, with respect to a Product, the Product-specific plan, developed by the applicable Sub-Committee and approved by the JSC, outlining the Development, Manufacturing and Commercialization (including the pursuit of Regulatory Approval) of such Product in the Territory, including a Commercialization Plan developed by Mylan and reviewed (but not approved, except for the [***]) by the JSC and other information as provided in Section 2.1(b).

1.86 “Profits (Losses)” means, with respect to a Product and a Calendar Quarter, the Net Sales for such Product: (a) less Shared Other Expenses; and (b) plus Sublicense Revenue.

1.87 “Profit Share” means Profits (Losses) multiplied by the Profit Share Percentage.

1.88 “Profit Share Percentage” means, with respect to each Party, fifty percent (50%), [***].

1.89 “Reference Product” means the reference brand biologic product for each Product, which as of the Effective Date are: (a) with respect to Momenta’s development compound referred to as “M834”, the fusion protein abatacept, as marketed and manufactured by or on behalf of Abatacept Innovator as Orencia®; (b) with respect to Momenta’s development compound referred to as [***], the [***] as marketed and manufactured by or on behalf of [***] Innovator as [***]; (c) with respect to Momenta’s development compound referred to as [***], the [***] as marketed and manufactured by or on behalf of [***] Innovator as [***]; (d) with respect to Momenta’s development compound referred to as [***], the [***] as marketed and manufactured by or on behalf of [***] Innovator as [***]; (e) with respect to Momenta’s development compound referred to as [***], the [***] as marketed and manufactured by or on behalf of [***] Innovator as [***]; and (f) with respect to Momenta’s development compound referred to as [***], the [***] manufactured and marketed by or on behalf of [***] Innovator as [***] or [***].

1.90 “Regulatory Approval” means, with respect to a country, all approvals, licenses, registrations, and regulatory authorizations required to make, store, import, transport, market and

sell a Product in such country as granted by the relevant Regulatory Authority, including any such pricing, labeling or reimbursement approvals.

1.91 “Regulatory Authority” means the FDA or any other counterpart or applicable government authority, court, tribunal, arbitrator, agency, legislative body, commission or other instrumentality of: (a) any national government of any country or territory or (b) any supranational body, in each case in the Territory that is responsible for granting applicable Regulatory Approvals.

1.92 “Regulatory Submission” means any application to a Regulatory Authority seeking (a) approval to administer an investigational Product to humans, including INDs, or (b) Regulatory Approval.

1.93 “Shared Other Expenses” means, for each Product, the Commercialization Expenses, Excess Further Expenses, COGS, Legal Expenses (subject to Article 5), Sublicense Expenses, and Third Party Intellectual Property Payment associated with such Product.

1.94 “Sublicense Expenses” all [***] pursuant to an agreement [***].

1.95 “Sublicense Revenue” means all consideration received by a Party or its Affiliates with respect to a sublicense granted to a Third Party(ies) to Develop, Manufacture or Commercialize any Product in the relevant country in the Territory (such a grant, a “Sublicense” and such Third Party, a “Sublicensee”), but excluding: [***].

1.96 “Territory” means with respect to the Products, the world.

1.97 “Third Party” means any Person other than Momenta or Mylan or any Affiliate of either Party.

1.98 “Third Party Intellectual Property Payments” means, with respect to a Product [***], any [***].

1.99 “United States” or “U.S.” means the United States of America, and its territories, districts and possessions.

1.100 “[***] Innovator” means [***] and [***].

1.101 “Valid Claim” means: [***] a claim in issued Patent Rights that has not: (i) expired or been canceled; (ii) been declared invalid by an unreversed and unappealable (or unappealed) decision of a court or other appropriate body of competent jurisdiction; (iii) been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise; or (iv) been abandoned by mutual written agreement of the Parties[***].

Definition		Section
AAA		12.11(c)(ii)
Active EL Party		5.4(d)

Acquiring Entity		12.3(c)(iii)
Acquiring Party		6.5[***]
Additional Development Activities		2.2(b)
Additional []* Activities		6.5(d)
[]*		[]*
[***]		[***]
[***]		[***]
Alliance Manager		3.7(a)
Annual Development Expense		4.2(a)(i)(5)(A)
Anti-Corruption Laws		11.7(a)
Anticipated Launch Date		2.4(f)(ii)
[]*		[]*
[]*		[]*
Assigning Party		12.3(b)
Bankruptcy Code		6.7
Breached Country		10.4(c)
Change of Control		12.3(c)(iii)
Co-Commercialization Agreement		2.7(a)
Co-Commercialization Notice		2.7(b)
Co-Commercialization Option		2.7(a)
Collaboration IP Plan		5.5(a)
[***]		[***]
Commercialization Plan		2.1(c)
Continuation Decision		2.6(a)

Continuation Payment		4.1(b)
CPM Amounts Used		4.2(a)(i)(6)
CPM Balance		4.2(a)(i)(6)
[]*		[]*
Defending Party		8.4
Development Milestone		4.1(c)
Development Reconciliation Amount		4.2(a)(i)(6)(i)
Disputed Matter		12.11(a)
Enforcement Litigation		5.4(b)
[***]		[***]
Excess Further Expenses		4.2(a)(iii)
Excess CPM Remaining Amount		4.2(a)(i)(6)(l)
[***]		[***]
FCPA		11.7(a)
Finalization of the CPM Balance		4.2(a)(i)(4)
HSR Act		12.12
HSR Clearance Date		12.12
[]*		[]*
Indirect Taxes		4.4(a)
Initial Development Activities		2.1(a)
JCC		3.14(a)
JDRC		3.11(a)
JFC		3.13(a)
JLC		3.15(a)

JMC		3.12(a)
Lead EL Party		5.4(c)(i)
Lead OCL Party		5.5(c)(i)
Legal Clearance Activities		5.5(a)
Momenta Annual Development Expenses		4.2(a)(i)(6)(a)
Momenta Annual Shortfall		4.2(a)(i)(6)(e)
Momenta COC Closing Date		12.3(c)(i)
[]*		[]*
Momenta COC Notice		12.3(c)(i)
[***]		[***]
[***]		[***]
[***]		[***]
Momenta Development Reconciliation Payment		4.2(a)(i)(6)(g)
Momenta Quarterly Shortfall		4.2(a)(i)(6)(f)
Mylan Annual Development Expenses		4.2(a)(i)(6)(b)
Mylan Annual Shortfall		4.2(a)(i)(6)(c)
[]*		[]*
Mylan COC Election Notice		12.3(c)(i)(1)
[]*		[]*
[***]		[***]
Mylan Development Reconciliation Payment		4.2(a)(i)(6)(h)
Mylan Indemnitees		8.2
Mylan Quarterly Shortfall		4.2(a)(i)(6)(d)
Non-Defending Party		8.4

Non-Lead OCL Party		5.5(c)(i)
Non-EL Lead Party		5.4(c)(i)
Passive EL Party		5.4(d)
Patent Matters		12.11(d)
Payee Party		4.4(a)
Paying Party		4.4(a)
Prior Confidentiality Agreement		7.7
Proposing Party		2.2(b)
Publications Policy		7.6
Quarterly Development Expenses		4.2(a)(i)(5)(B)
[]*		[]*
[***]		[***]
Replacement Product		2.6(b)
Rules		12.11(c)(ii)
Summary Statement		4.2(b)
Sub-Committee		3.5
Sublicense		1.95
Sublicensee		1.95
Substituted Product		2.6(b)
Term		10.1
Termination Date		10.1
Trade Control Laws		11.8(a)
Transferee		12.3(b)
UKBA		11.7(a)

ARTICLE 2.
DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION OF THE PRODUCTS

From and after the Effective Date, the Parties intend and agree [***] to Develop, Manufacture and Commercialize the Products as described in this Agreement and in accordance with the applicable Product Work Plan.

2.1 Product Work Plans.

(a) The initial Product Work Plan for each Product shall be prepared and approved by the JSC within [***] of the Effective Date of this Agreement. These initial Product Work Plans shall incorporate any remaining Initial Development Activities. Thereafter, the JSC shall review, update as appropriate and (other than with respect to the Commercialization Plan included therein except for the [***]) approve Product Work Plans on at least an [***] basis and may modify Product Work Plans more frequently as may be deemed necessary by the Parties from time-to-time. Each revised Product Work Plan for a Product shall contain substantially the level of detail and cover at least the same matters (as described in Section 2.1(b) below, to the extent applicable based on the then-current stage of Development or Commercialization) as the initial Product Work Plan for such Product. Momenta is authorized to perform the Development Activities (“Initial Development Activities”) and incur the Development Expenses associated therewith, in each case as set forth in Exhibit 2.1(a)(1) hereto, following the Effective Date and prior to the time the initial Product Work Plan is approved. For clarity, the Product Work Plan for a Product will not include Commercialization Activities until the first Commercialization Plan for such Product is provided pursuant to Section 2.1(c) below.

(b) The Product Work Plan for each Product shall include, as appropriate: (i) [***]; (ii) [***]; (iii) [***]; (iv) [***]; (v) [***] (vi) a [***].

(c) The initial Commercialization plan (the “Commercialization Plan”) for each Product will be prepared [***] and provided to the JSC no later than [***] as part of the Product Work Plan: (i) [***]; and (ii) [***]; and (iii) [***]. The Commercialization Plan shall: (A) [***]; and (B) [***]: (1) [***]; and (2) [***]; and (3) [***].

2.2 Development Responsibilities and Diligence.

(a) Diligence. Each Party will [***] conduct the Development Activities (including all regulatory activities) assigned to it in the applicable Product Work Plan. All such Development Activities shall be conducted in accordance with this Agreement, the applicable Product Work Plan and Applicable Law. Momenta will be primarily responsible, in collaboration with Mylan, for managing execution, and contracting with Third Parties (other than Third Parties for supply of Product) for the conduct, of pre-clinical Development Activities, Initial Clinical Trials and Additional Clinical Trial(s) for M834 and for pre-clinical Development Activities and Initial Clinical Trials for the other Products. Mylan will be primarily responsible, in collaboration with Momenta, for managing execution, and contracting with Third Parties (other than Third Parties for supply of Product) for the conduct, of Additional Clinical Trial(s) of the Products (other than M834). Notwithstanding the preceding allocations of responsibility, the

Parties may, as appropriate and as mutually agreed, assign specific Development Activities to either Party. Notwithstanding the foregoing allocation of responsibility for contracting with Third Parties, the Parties will cooperate with respect to [***].

(b) Additional Development Activities. If a Party (the “Proposing Party”) wishes to conduct Development Activities that are not covered by an approved Product Work Plan (“Additional Development Activities”), then the Proposing Party shall provide the JSC with a proposal for such Additional Development Activities, including a description of, and rationale for, the activities, timelines for the activities and a projected budget for such activities, for review and approval, and shall incorporate reasonable comments from the JSC. If the JSC approves such Additional Development Activities, then such Additional Development Activities shall be incorporated into the existing Product Work Plan (thereby becoming Development Activities), and the costs of such Additional Development Activities [***].

(c) Regulatory. Unless otherwise determined by the JSC or as set forth in the applicable Product Work Plan: (i) Mylan shall be responsible for preparing and filing the initial IND for each Product outside the United States, [***]; (ii) Momenta shall be responsible for preparing and filing the initial IND for each Product in the United States, [***]; (iii) the Parties shall cooperate in the [***]; (iv) all applications for Regulatory Approvals and other Regulatory Submissions outside the U.S. for the Product shall be filed in Mylan or its Affiliate’s name; and (v) all applications for Regulatory Approvals and other Regulatory Submissions in the U.S. for the Product shall be filed in Momenta or its Affiliate’s name; except that, [***]: (A) Mylan shall be primarily responsible for correspondence and interactions with Regulatory Authorities with respect to the Products in the Territory outside the United States; and (B) Momenta shall be primarily responsible for correspondence and interactions with Regulatory Authorities with respect to the Products in the United States until [***]. All Regulatory Submissions shall be subject to review and approval by both Parties. Each Party shall provide the other Party with copies of all material correspondence with Regulatory Authorities with respect to the Products. Appropriate individuals from each Party will be invited as meeting participants and have the right to attend and participate in any meetings with Regulatory Authorities in the Territory with respect to the Products. The foregoing activities shall be described in more detail in the [***].

(d) Clinical Trial Protocols. All protocols for Clinical Development of the Products to be conducted pursuant to the Collaboration shall be subject to review and approval by the JSC. Upon the request of either Party, the Parties shall [***].

(e) Development Activity Reports. Each Party will report on Development Activities undertaken by it in performance of the Product Work Plan. Such reports shall be provided in connection with meetings of the JSC and as otherwise reasonably requested by the other Party.

(f) Data Access. Without limiting the reporting obligations set forth in Section 2.2(e) above, each Party shall provide the other Party with access to [***] data, including but not limited to [***], including but not limited to [***]. After receipt of a Party’s written request, the other Party shall [***]. For clarity, all such data, [***].

2.3 Manufacturing Responsibilities and Diligence

(a) Diligence. Each Party shall [***] conduct the Manufacturing Activities assigned to it under the applicable Product Work Plan. All such Manufacturing Activities shall be conducted in accordance with this Agreement, the applicable Product Work Plan and Applicable Law. Momenta will be primarily responsible for entering into contracts with Third Parties for clinical supply of the Products and Mylan will be primarily responsible for entering into contracts with Third Parties for Commercial Supply of the Products (except M834). Notwithstanding the preceding allocations of responsibility, the Parties may, as appropriate and as mutually agreed, assign specific Manufacturing responsibilities to either Party. Notwithstanding the foregoing allocation of responsibility for contracting with Third Parties, the Parties [***].

(b) The Party that bears primary responsibility for Manufacturing Activities for a Product, as set forth in the Product Work Plan, shall [***] ensure adequate supply of pre-clinical and clinical supply of Product (including the bulk process intermediate and finished Product) to Develop such Product as contemplated by the Product Work Plan, and [***] to ensure adequate Manufacturing capacity to meet forecasted commercial demand for such Product.

(c) Third Party Manufacturers. If a Party uses any Third Party to fulfill its Manufacturing obligations under this Agreement, the Third Party and the terms of the agreement with such Third Party [***]. Each Party shall have the right to conduct quality inspection(s) of each Third Party manufacturer of the Products or any component of the Products for use in the clinical trials included in the Product Work Plans or with respect to commercial supply, and a Party may withhold or withdraw its approval of such Third Party manufacturers in the event any such inspection reveals material quality issues. The Parties shall [***].

(d) Manufacturing Activity Reports. Each Party will report on Manufacturing Activities undertaken by or on behalf of it in performance of the Product Work Plan. Such reports shall be provided in connection with each meeting of the JSC and as otherwise reasonably requested by the other Party. The reports provided by each Party pursuant to this Section 2.3(d) shall include, [***].

(e) Transfer of Manufacturing Process. Upon a Party’s request, and otherwise in accordance with the applicable Product Work Plan, the other Party shall cooperate with such request to transfer any manufacturing processes for the Products (including cell lines and drug substance) developed by or on behalf of the transferring Party to the other Party or its designee for purposes of Developing and Commercializing the Products in accordance with this Agreement.

2.4 Commercialization Responsibilities and Diligence

(a) Diligence. The Commercialization Plan shall consist of [***] Commercialization Activities [***]. Each Party shall [***] conduct the Commercialization Activities assigned to it in the applicable Product Work Plan. All such Commercialization Activities shall be conducted in accordance with this Agreement, the applicable Product Work Plan and Applicable Law. Mylan will lead the global Commercialization efforts with respect to the Products in the Territory. Mylan shall [***] Launch each Product within each Major Country promptly after: (i) [***]; (ii) [***]; and (iii) [***].

(b) Mylan Responsibilities. Except as specifically provided otherwise in the applicable Product Work Plan, Mylan shall, with respect to each Product, [***] to [***], except that [***].

(c) Commercial Information Reports. Within [***] and updated regularly, as appropriate, the Parties shall share with each other material market information collected or prepared by or on behalf of such Party relating to each Product, including: (i) [***]; (ii) [***]; and (iii) [***].

(d) Commercialization Activity Reports. Each Party will report on the Commercialization activities undertaken by it in performance of the applicable Product Work Plan in connection with each meeting of the JSC, including [***]. In addition, commencing no later than the First Commercial Sale of a Product, each Party will, on a Product-by-Product and a country-by-country basis, no more frequently than [***] (unless otherwise agreed by the Parties), provide to the other Party upon request, [***].

(e) Product Recalls. Each Party shall promptly notify the other Party of any information received by it that could reasonably form the basis for a recall, market withdrawal or other corrective action of a Product, in sufficient detail to allow the Parties to comply with any and all Applicable Law to the extent such level of detail is available to the reporting Party. Each Party shall promptly notify the other Party of any material actions to be taken with respect to any recall or market withdrawal or other corrective action related to a Product prior to such action to permit each Party a reasonable opportunity to consult with the other Party with respect thereto. [***]. All final decisions with respect to any recall, market withdrawals or any other corrective action related to the Product in the Territory shall be made by [***], except that [***]. Each Party will keep the other Party reasonably informed with respect to any recalls, market withdrawals or other corrective action with respect to the Products in the Territory and will consider any comments from such other Party with respect thereto [***].

(f) Legal Clearance and Launch.

(i) The Parties agree that Mylan may, [***], Launch (on a country-by-country basis) any Product [***], Mylan may, [***], Launch such Product in such country [***].

(ii) Relevant Patents.

(1) At least [***] prior to the anticipated Launch of a Product in a country as indicated in the most recent Commercialization Plan (“Anticipated Launch Date”), [***].

(2) Any such [***], to Mylan by written notice at least [***] prior to the Anticipated Launch Date [***] shall be [***].

(3) Momenta may update the [***], by providing written notice of such update to Mylan, at any time that is at least [***] prior to the Anticipated Launch Date [***] (A) on or after [***] prior to the Anticipated Launch Date and before such [***] notice date, or (B) prior to such [***] (any such [***] added pursuant to this Section 2.4(f)(ii)(3) may also be referred to herein as, [***]).

(iii) Beginning no earlier than [***] prior to the Anticipated Launch Date, on a country-by-country basis, if Mylan desires to Launch a Product in such country [***], then Mylan shall so notify Momenta in writing, and, along with such notice, Mylan shall provide Momenta with [***]. Within [***] of receipt of such notice and [***].

(iv) [***].

(v) [***], then notwithstanding anything to the contrary herein, the following shall apply:

(1) The [***] will automatically and immediately [***], and the [***], subject to paragraph 5 below.

(2) In consideration for the [***].

(3) [***].

(4) Mylan agrees to [***] means all [***]. If any [***] arises, Momenta shall [***]. Notwithstanding the foregoing, [***]. Momenta shall [***]. Mylan shall [***].

(5) [***], Momenta shall [***]. Such [***] shall be [***] through a [***]. An example [***].

2.5 Limitations on Final Decision Authority. Notwithstanding the provisions of Section 2.4(b), but without limiting Mylan’s rights described in Section 2.4(f), [***].

2.6 Continuation Decisions and Product Substitutions.

(a) Continuation Decisions. For each Product (other than M834), each Party shall make a continuation decision as to whether to continue the Development, Manufacture and Commercialization of such Product pursuant to this Agreement as set forth in this Section 2.6 (each a “Continuation Decision”) following: (i) [***], (ii) [***], (iii) [***]; (iv) [***]; and (v) [***]. The applicable Sub-Committees shall provide the JSC with the following information for such Product (other than M834) to enable the JSC to make its recommendation regarding the Continuation Decision: an updated Product Work Plan, including [***]. After receipt of [***], the JSC will meet and make a recommendation with respect to each such Continuation Decision. Each Party shall notify the other Party in writing within [***] after such JSC meeting of the notifying Party’s decision to either continue or not to continue the Development, Manufacture and Commercialization of the applicable Product (other than M834) under the Collaboration. Notwithstanding anything to the contrary herein, unless otherwise agreed by the Parties in advance in writing, each Party shall notify the other of its Continuation Decision prior to either Party [***].

(1) If Mylan and Momenta each decide to continue with the Development, Manufacture and Commercialization of a given Product (other than M834) under the Collaboration, then Mylan shall make the applicable Continuation Payment for such Product to Momenta pursuant to Section 4.1(b), and the applicable Product Work Plan shall be updated by the JSC as appropriate to reflect such decision.

(2) If Mylan decides to continue with the Development, Manufacture and Commercialization of a given Product (other than M834) under the Collaboration, but Momenta decides not to continue with the Development, Manufacture and Commercialization of such Product (other than M834) under the Collaboration, then [***].

(3) If Mylan decides not to continue with the Development, Manufacture and Commercialization of a given Product (other than M834) under the Collaboration, but Momenta decides to continue with the Development, Manufacture and Commercialization of such Product under the Collaboration, then [***].

(4) If Mylan and Momenta each decide not to continue with the Development, Manufacture and Commercialization of a given Product (other than M834) under the Collaboration, the [***].

(b) Product Substitutions. Prior to the Continuation Decision with respect to each Product (“Substituted Product”), either Party may propose to the other Party that a [***] (“Replacement Product”) be substituted for such Product, and a meeting of the Parties shall be held within [***] of such request to determine whether to make such substitution. If the Parties [***] agree in writing to such substitution, then [***].

2.7 Momenta’s Co-Commercialization Option.

(a) In General. On a Product-by-Product basis, Mylan hereby grants to Momenta an option (each, a “Co-Commercialization Option”) to play a supporting commercial role for such Product in the United States, by performing such activities in support of Mylan’s Commercialization of the Product as determined by the JSC, in accordance with this Agreement, the applicable Commercialization Plan and a separate co-Commercialization agreement (the “Co-Commercialization Agreement”) to be negotiated [***] by the Parties within [***] subsequent to Momenta’s exercise of the Co-Commercialization Option with respect to a particular Product. If any inconsistency arises between the terms of this Agreement and the terms of a Co-Commercialization Agreement, the terms of this Agreement shall prevail.

(b) Exercise. Mylan shall give Momenta written notice (the “Co-Commercialization Notice”) at least [***] before [***] as set forth in the then-current Product Work Plan, and shall provide with such notice: (i) [***] U.S.; and (ii) [***]. Momenta may exercise its Co-Commercialization Option with respect to such Product by written notice to Mylan no later than [***] after Momenta receives a Co-Commercialization Notice. The Parties shall continue to share Profits (Losses) in accordance with Section 4.2 with respect to each Product, regardless of whether Momenta exercises or does not exercise its Co-Commercialization Option with respect to any Product. Momenta shall not have the right to Commercialize any Product, unless and until a Co-Commercialization Agreement, which permits the Commercialization of such Product in the U.S., is entered into by the Parties. For clarity, Momenta’s role under a Co-Commercialization Agreement may include [***].

ARTICLE 3.
GOVERNANCE

From and after the Effective Date, the Parties intend that the Development, Manufacturing and Commercialization Activities and associated Legal Activities and decisions for each Product be conducted and managed using [***] and subject to the oversight of the Joint Steering Committee, and any relevant Sub-Committees or working groups.

3.1 Generally. The Parties hereby establish a joint steering committee (“Joint Steering Committee” or “JSC”) composed of senior members from each Party, including one (1) Alliance Manager (as defined in Section 3.7(a)), to oversee the Development, Manufacturing and Commercialization of all Products under this Agreement. The structure, scope of responsibility and authority of the JSC shall be as set forth in this Article 3.

3.2 Structure. The JSC shall initially consist of four (4) representatives, one of which shall be an Alliance Manager as provided in Section 3.7 below, from each of Mylan and Momenta. Each of the representatives shall be of the seniority and experience appropriate for service on the JSC in light of the functions, responsibilities and authority of the JSC and the status of the Development, Manufacture and Commercialization of the Products subject to the Agreement from time to time. The JSC shall appoint a chairperson from among its members, which shall initially be a representative from [***], and then alternate annually between the Parties. The chairperson shall be responsible for notifying the Parties’ representatives of JSC meetings and for leading the meetings. The initial JSC representatives of each Party (other than the Alliance Managers) are set forth on Exhibit 3.2. Each Party may replace its representatives by providing written notice to the other Party. Employees and other representatives of each Party that are not members of the JSC may attend meetings of the JSC and any Sub-Committees (as defined below) as requested by members of the JSC, and subject to the approval of the other Party with respect to non-employee representatives, to further the activities contemplated by this Agreement.

3.3 Time and Location of Meetings. The JSC shall meet at such times and places, in person or by telephone conferencing, web-conferencing, video conferencing or other electronic communication, as the JSC shall determine to carry out its responsibilities; provided, however, that the initial meeting of the JSC shall be held in person at such location as mutually agreed upon by the Parties no later than [***] after the Effective Date. Thereafter, the JSC shall meet in person at least two (2) times each Calendar Year and shall hold regular teleconferences between meetings not less frequently than once during each Calendar Quarter in which no in person meeting of the JSC is held. A Party may also call a special meeting of the JSC by providing at least [***] prior written notice to the other Party if such Party reasonably believes that a matter within the JSC’s authority must be addressed prior to the next scheduled meeting, in which event such Party shall provide the other Party a proposed agenda, together with such meeting request. The location of the in-person meetings shall alternate between the sites of the two (2) Parties. If a representative of a Party cannot attend a meeting, such Party may designate an alternate employee of such Party to attend such meeting in place of the absent representative.

3.4 Minutes. The JSC shall designate for each meeting one (1) Alliance Manager who shall be responsible for drafting and issuing minutes of each JSC meeting reflecting all material items discussed and any agreements of the JSC, which minutes shall be distributed to all

JSC members for review and approval. Such minutes shall provide a description in reasonable detail of the discussions held at the meeting and a list of any actions, decisions or determinations approved by the JSC. The Parties shall endeavor to finalize and approve the minutes of each JSC meeting within [***] after each such meeting. Approval of minutes shall be indicated by signature by one (1) JSC member from each Party. Final minutes of each meeting shall be distributed to the members of the JSC by the chairperson.

3.5 Sub-Committees. The JSC shall agree upon the formation of certain sub-committees (each a “Sub-Committee”), each with an equal number of representatives from Mylan and Momenta, to address specific issues in greater detail, including (as described below) a Development and regulatory Sub-Committee, a Manufacturing Sub-Committee, a finance Sub-Committee, a Commercialization Sub-Committee, and a Sub-Committee for Legal Activities and intellectual property.

3.6 Scope of Authority; Responsibilities.

(a) The JSC shall perform the functions and assume the responsibilities and have such authority as set forth in this Agreement. The JSC has the right to establish a joint project team to implement cross-functional aspects of the Product Work Plan, or other team that the JSC deems necessary, and the JSC shall have such other responsibilities as the Parties may agree in writing from time to time.

(b) The JSC’s responsibilities shall be: (i) overseeing the Collaboration; (ii) [***] the Product Work Plan for each Product no less than once per Calendar Year, as well as any amendments thereto, [***]: (A) [***] and (B) [***]; (iii) [***] for each Product (which shall be subject to approval by the Parties); (iv) reviewing all publications described in Section 7.6, and review and approve a publications policy for such publications regarding the Products; (v) [***] for each Product to the extent included in the Commercialization Plan; (vi) [***] and related information for each Product; (vii) [***]; (viii) [***] for each Product as part of the Product Work Plan and [***]; (ix) [***]; (x) [***] for each Product, and [***] for each Product; (xi) [***] for each Product; (xii) [***] for each Product; (xiii) [***]; (xiv) [***] for each Product, including the [***]; (xv) [***]; and (xvi) other matters expressly assigned to the JSC in this Agreement.

(c) For the avoidance of doubt, the JSC shall have no authority to: (i) amend any of the terms of this Agreement, including by means of JSC minutes, Product Work Plans or otherwise; (ii) waive any rights that either Party may otherwise have pursuant to this Agreement or otherwise; (iii) allocate the ownership of any Patent Rights or rights to any Know-How or the Parties’ rights to apply for Patent Rights; (iv) interpret this Agreement, or determine whether or not a Party has met its diligence or other obligations under the Agreement or whether or not a breach of this Agreement has occurred; or (v) require a Party to allocate resources to the Development, Manufacture or Commercialization of the Products other than as set forth in the agreed upon Product Work Plan, or otherwise agreed by such Party in writing. Notwithstanding the foregoing, the JSC may make recommendations to the Parties for amendment of this Agreement.

3.7 Alliance Managers.

(a) Appointment. Each of the Parties shall appoint a single individual to act as a single point of contact between the Parties to assure a successful Collaboration (each, an “Alliance Manager”). Each Party may change its designated Alliance Manager from time to time upon written notice to the other Party. Any Alliance Manager may designate a substitute to temporarily perform the functions of that Alliance Manager by written notice to the other Party.

(b) Responsibilities. The Alliance Managers shall be non-voting members of the JSC and each Sub-Committee and shall attend all JSC and Sub-Committee meetings and support the chairpersons of JSC and Sub-Committees in the discharge of their responsibilities, including by (i) preparing and circulating meeting agendas, (ii) keeping written minutes that reflect all decisions made and action items identified at such meetings, (iii) circulating such minutes to JSC members and integrating comments from the JSC members, and (iv) facilitating communications between the Parties.

3.8 Decisions; Disputes.

(a) Except as expressly set forth in Section 2.4(b), with respect to matters for which the JSC has decision-making authority, the decisions of the JSC (including any Sub-Committee thereof) must be unanimous, with the representatives of Mylan having, collectively, one (1) vote and representatives of Momenta having, collectively, one (1) vote.

(b) If, [***], a dispute arises regarding matters within the scope of the decision-making authority of the JSC (other than any JSC disputes under Section 5.3(a)(iii), Section 5.4 or Section 5.5), a subsequent meeting of the JSC shall be held to attempt to resolve such dispute. If the JSC fails to reach a unanimous decision on its resolution within [***] after the date when the dispute was presented to the JSC at such subsequent meeting, then, except as otherwise set forth in this Agreement, the matter shall be resolved pursuant to Section 12.11(a) and, as necessary, Section 12.11(c). If a dispute arises regarding matters within the scope of responsibilities of the JSC under Section 5.3(a)(iii), Section 5.4 or Section 5.5, then such disputes will not be resolved pursuant to Section 12.11 and will instead be addressed under Section 5.3(a)(iii), Section 5.4 or Section 5.5 (as applicable).

3.9 Costs and Expenses. [***] incurred by its respective representatives in connection with attending the meetings and otherwise being part of the JSC and of the Sub-Committees. For the avoidance of doubt, [***].

3.10 Term of the JSC and Sub-Committees. The JSC and each Sub-Committee, as applicable, shall, unless otherwise mutually agreed by the Parties, continue with respect to each Product through the Term of the Agreement.

3.11 Development and Regulatory Sub-Committee

(a) Membership. The Parties shall, as soon as practicable and, in any event, no later than [***], form a Development and regulatory Sub-Committee to develop and oversee execution of the plans for Development and regulatory affairs with respect to the Products (the “JDRC”). The JDRC shall consist of three (3) representatives of Mylan and three (3) representatives of Momenta, or such other equal number of representatives from each Party as the Parties may agree in writing. Each member of the JDRC will have knowledge and expertise

in the Development of or regulatory requirements for products similar to the Products, and will have appropriate seniority within the applicable Party. Subject to the foregoing, each Party may replace its representatives to the JDRC at any time upon written notice to the other Party (subject, however, to such replacement complying with the requirements of this Section 3.11(a)).

(b) Responsibilities of JDRC. Subject to the terms of this Agreement, the JDRC shall have the following responsibilities:

(i) to develop the portions of the Product Work Plans covering Development Activities and regulatory activities for each Product;

(ii) to oversee the execution of the Development Activities and regulatory activities set forth in each [***] Product Work Plan;

(iii) to coordinate and oversee regulatory matters with respect to the Development and Manufacture of Products, [***];

(iv) to provide a forum to discuss the Development Activities and regulatory activities hereunder, including any issues related thereto and potential remediation plans for such issues; and

(v) to provide a forum to discuss Third Parties engaged or proposed to be engaged to perform Development Activities and regulatory activities on behalf of a Party and the activities to be performed by such Third Parties.

(c) Meetings. The JDRC shall meet at least four (4) times per year (or as otherwise agreed to by the Parties), and such meetings may be conducted in person, by videoconference or by teleconference. [***] in connection with its participation on the JDRC. In addition, either Party may call a meeting of the JDRC at any time upon [***] notice. Meetings of the JDRC will be effective only if at least one (1) representative of each Party is present at or participating in such meeting.

(d) JDRC Authority. Subject to Section 2.2(a), the JDRC shall have decision-making authority with respect to how the day-to-day Development Activities and regulatory activities are being carried out pursuant to the Product Work Plans.

3.12 Manufacturing Sub-Committee.

(a) Membership. The Parties shall, as soon as practicable and, in any event, no later than [***], form a Manufacturing Sub-Committee to develop and oversee execution of the plans for the Manufacture of the Products (the “JMC”). The JMC shall consist of three (3) representatives of Mylan and three (3) representatives of Momenta, or such other equal number of representatives from each Party as the Parties may agree in writing. Each member of the JMC will have knowledge and expertise in the Manufacturing requirements for products similar to the Products, and will have appropriate seniority within the applicable Party. Subject to the foregoing, each Party may replace its representatives to the JMC at any time upon written notice to the other Party (subject, however, to such replacement complying with the requirements of this Section 3.12(a)).

(b) Responsibilities of JMC. Subject to the terms of this Agreement, the JMC shall have the following responsibilities:

(i) to develop the portions of the Product Work Plans covering Manufacturing Activities for each Product;

(ii) to oversee the execution of the Manufacturing Activities set forth in each [***] Product Work Plan;

(iii) to provide a forum to discuss the Manufacturing Activities hereunder, [***];

(iv) to provide a forum to discuss any issues relating to the Manufacturing Activities hereunder and propose remediation plans to resolve such issues; and

(v) to provide a forum to discuss Third Parties engaged or proposed to be engaged to perform Manufacturing Activities on behalf of a Party and the activities to be performed by such Third Parties.

(c) Meetings. The JMC shall meet at least four (4) times per year (or as otherwise agreed to by the Parties), and such meetings may be conducted in person, by videoconference or by teleconference. [***] in connection with its participation on the JMC. In addition, either Party may call a meeting of the JMC at any time upon [***] notice. Meetings of the JMC will be effective only if at least one (1) representative of each Party is present at or participating in such meeting.

(d) JMC Authority. Subject to Section 2.3(a), the JMC shall have decision-making authority with respect to how the day-to-day Manufacturing Activities are being carried out pursuant to the Product Work Plans.

3.13 Finance Sub-Committee.

(a) Membership. The Parties shall, as soon as practicable and, in any event, no later than [***], form a finance Sub-Committee to oversee expenses and Profits (Losses) associated with the Development, Manufacture and Commercialization of the Products, and the sharing thereof (the “JFC”). The JFC shall consist of two (2) representatives of Mylan and two (2) representatives of Momenta, or such other equal number of representatives from each Party as the Parties may agree in writing. Each member of the JFC will have knowledge and expertise in financial matters for products similar to the Products, and will have appropriate seniority within the applicable Party. Subject to the foregoing, each Party may replace its representatives to the JFC at any time upon written notice to the other Party (subject, however, to such replacement complying with the requirements of this Section 3.13(a)).

(b) Responsibilities of JFC. Subject to the terms of this Agreement, the JFC shall have the following responsibilities:

(i) to develop, and oversee the Parties execution of the Product Work Plans against the budgets included in the Product Work Plans;

(ii) to coordinate and oversee the reporting and reconciliation of costs and Profits (Losses) with respect to the Products pursuant to Section 4.2;

(iii) to provide a forum to discuss financial and accounting matters with respect to the Development, Manufacturing and Commercialization activities conducted hereunder, including cost overruns and expenses associated with Additional Development Activities;

(iv) to review quarterly financial statements and forecasts to ensure consistency with any applicable budgets; and

(v) to work with the other Sub-Committees and the JSC to ensure that their respective activities are in accordance with the budgets set forth in the Product Work Plans.

(c) Meetings. The JFC shall meet at least [***] in connection with the reporting and reconciliation to be conducted pursuant to Section 4.2 (or as otherwise agreed to by the Parties), and such meetings may be conducted in person, by videoconference or by teleconference. [***] in connection with its participation on the JFC. In addition, either Party may call a meeting of the JFC at any time upon [***] notice. Meetings of the JFC will be effective only if at least one (1) representative of each Party is present at or participating in such meeting.

(d) JFC Authority. The JFC shall have decision-making authority with respect to accounting matters related to the reporting done pursuant to Section 4.2.

3.14 Joint Commercialization Sub-Committee.

(a) Membership. The Parties shall, as soon as practicable and, in any event, no later than [***], form a Commercialization Sub-Committee to oversee execution of the Commercialization Plans (the “JCC”). The JCC shall consist of four (4) representatives of Mylan and four (4) representatives of Momenta, or such other equal number of representatives from each Party as the Parties may agree in writing. Each member of the JCC will have knowledge and expertise in the commercialization of products similar to the Products, and will have appropriate seniority within the applicable Party. Without limiting the foregoing, each Party shall have at least one (1) representative to the JCC with expertise in regulatory and medical affairs matters. Subject to the foregoing, each Party may replace its representatives to the JCC at any time upon written notice to the other Party (subject, however, to such replacement complying with the requirements of this Section 3.14(a)).

(b) Responsibilities of JCC. Subject to the terms of this Agreement, the JCC shall have the following responsibilities:

(i) to [***];

(ii) to [***];

(iii) to [***];

(iv) to [***]; and

(v) to [***].

(c) Meetings. The JCC shall meet at least four (4) times per year (or as otherwise agreed to by the Parties), and such meetings may be conducted in person, by videoconference or by teleconference. [***] in connection with its participation on the JCC. In addition, either Party may call a meeting of the JCC at any time upon [***] notice. Meetings of the JCC will be effective only if at least one (1) representative of each Party is present at or participating in such meeting.

(d) JCC Authority. Subject to Section 2.4(a) and (b), the JCC shall have decision-making authority with respect to [***].

3.15 Legal Activities and Intellectual Property Sub-Committee.

(a) Membership. The Parties shall, as soon as practicable and, in any event, no later than [***], form a Sub-Committee to develop and oversee the execution of the Collaboration IP Plan for freedom to operate regarding the Products and other Legal Activities with respect to the Products (the “JLC”). The JLC shall consist of three (3) representatives of Mylan and three (3) representatives of Momenta, or such other equal number of representatives from each Party as the Parties may agree in writing. One of each of the Parties’ representatives to the JLC shall also be a member of the JDRC or JCC. Each Party shall bear its own expenses in connection with its participation on the JLC.

(b) Responsibilities of JLC. Subject to the terms of this Agreement, the JLC shall have the following responsibilities:

(i) to [***] with respect to the Products;

(ii) to [***];

(iii) to [***];

(iv) to [***]; and

(v) to [***].

(c) Meetings. The JLC shall meet at least four (4) times per year (or as otherwise agreed to by the Parties), and such meetings may be conducted in person, by videoconference or by teleconference. [***] in connection with its participation on the JLC. In addition, either Party may call a meeting of the JLC at any time upon [***] notice. Meetings of the JLC will be effective only if at least one (1) representative of each Party is present at or participating in such meeting.

(d) JLC Authority. Except as expressly set forth in Article 5, the JLC shall have decision-making authority with respect to how the day-to-day Legal Activities are being carried out pursuant to the Collaboration IP Plan.

3.16 Limits on Sub-Committees’ Power. Notwithstanding the foregoing: (a) any decision that this Agreement provides is to be made by the Parties shall not be within the

authority of any Sub-Committee; and (b) no Sub-Committee shall have the authority to: (i) directly impose any financial obligation on either Party or its Affiliates, (ii) impose a resolution on the Parties with respect to any dispute regarding the existence or amount of any payment to be made under this Agreement, (iii) directly impose on either Party, an obligation to allocate such Party’s or its Affiliate’s tangible or intangible resources and assets in a certain manner, or (iv) amend, interpret, modify or waive compliance with this Agreement.

ARTICLE 4.
FINANCIAL TERMS

4.1 Consideration.

(a) Up-Front Payment. Within [***], Mylan shall make a non-creditable, non-refundable upfront payment to Momenta of Forty-Five Million U.S. Dollars ($45,000,000).

(b) Continuation Payments. For each Product (other than M834) with respect to which both Parties decide to continue the Development, Manufacture and Commercialization pursuant to Section 2.6(a), Mylan shall make a continuation payment to Momenta of [***] within [***] after each such decision by the Parties (each, a “Continuation Payment”). For clarity, the total amount of Continuation Payments made to Momenta under this Agreement shall not exceed an aggregate of [***].

(c) Development Milestone. For M834, Mylan shall pay to Momenta [***] within [***] after the first achievement by or on behalf of Momenta of [***] (the “Development Milestone”). Such Development Milestone payment shall be payable [***]. For clarity, if such Development Milestone event is not achieved, Mylan shall not owe the corresponding milestone payment.

4.2 Cost Share and Profit Share. The Parties shall share all Development Expenses and Shared Other Expenses for each Product, incurred after the Effective Date, as set forth below in this Section 4.2. The Parties shall share all Profits (Losses) for each Product according to the Profit Share Percentage. All such Shared Other Expenses and Profits (Losses) for each Product shall be subject to reconciliation, reimbursement and payment pursuant to the Profit Share calculation set forth in Sections 4.2(b) — (d) below. For clarity, each Shared Other Expense shall be accounted for only once when calculating the Profit Share, even if the activity with respect to which such expense is incurred is described in more than one (1) subcategory of Shared Other Expenses.

(a) Development Expenses and Shared Other Expenses.

(i) Development Expenses.

(1) Incurring Development Expenses. Subject to Section 4.2(a)(i)[***]-(6), each Party shall initially bear all Development Expenses it incurs as set forth in each Product Work Plan (or as set forth in Exhibit 2.1(a)(1) prior to approval of such Product Work Plan) for each Product. Without limiting the foregoing, [***].

[***].

(4) Finalization of the CPM Balance. In the first Calendar Quarter in which (A) the CPM Balance [***] or (B) the [***] the “Finalization of the CPM Balance”), then the Parties shall initiate reconciliation of Development Expenses in such Calendar Quarter (and thereafter) [***] and share Development Expenses in a Calendar Quarter as follows:

(A) If the [***] is [***], then the Mylan Development Reconciliation Payment in such Calendar Quarter shall [***].

(B) If the [***] is [***], then the Momenta Development Reconciliation Payment in such Calendar Quarter shall [***].

(5) Reconciliation of Development Expenses.

(A) [***]: Without limiting the reporting obligations in Sections 4.2(b) and (c) below, [***], within [***] after the expiration of the applicable Calendar Year [***], each Party shall provide the other Party with a report of its Development Expenses for all Products for such Calendar Year [***] (individually, a Party’s “Annual Development Expenses”). If there is a Development Reconciliation Amount owed by a Party for a Calendar Year [***], then it shall be paid to the other Party within [***] after delivery of both Parties’ reports of Annual Development Expenses for such Calendar Year [***].

(B) [***]: Without limiting the reporting obligations in Sections 4.2(b) and (c) below, [***], within [***] after the expiration of the applicable Calendar Quarter, each Party shall provide the other Party with a report of its Development Expenses for all Products for such Calendar Quarter (individually, a Party’s “Quarterly Development Expenses”). If there is a Development Reconciliation Amount owed by a Party for a Calendar Quarter, then it shall be paid to the other Party within [***] after delivery of both Parties’ reports of Quarterly Development Expenses for such Calendar Quarter. In addition, [***].

(6) Example and Definitions.

An example calculation of this reconciliation process is set forth in Exhibit 4.2(a)(i). For purposes of the foregoing,

a. “Momenta Annual Development Expenses” means for a Calendar Year [***] incurred by Momenta in such Calendar Year [***].

b. “Mylan Annual Development Expenses” means for a Calendar Year [***] incurred by Mylan in such Calendar Year [***].

c. “Mylan Annual Shortfall” means [***] the Momenta Annual Development Expenses [***] for any Calendar Year [***].

d. “Mylan Quarterly Shortfall” means [***] the Momenta Quarterly Development Expenses [***] in a Calendar Quarter.

e. “Momenta Annual Shortfall” means [***] the Mylan Annual Development Expenses [***] in a Calendar Year [***].

f. “Momenta Quarterly Shortfall” means [***] the Mylan Quarterly Development Expenses [***] in a Calendar Quarter.

g. “Momenta Development Reconciliation Payment” is the amount determined under [***] and Section 4.2(a)(i)(4)(B) .

h. “Mylan Development Reconciliation Payment” is the amount determined under [***] and Section 4.2(a)(i)(4)(A).

i. The Momenta Development Reconciliation Payment and the Mylan Development Reconciliation Payment may each be referred to herein as a “Development Reconciliation Amount.”

j. “CPM Balance” for a Calendar Year [***] means the [***] paid [***] under this Agreement as of the end of such Calendar Year [***], reduced by the [***] during [***].

k. “CPM Amount Used” for a Calendar Year [***] means the amount of the CPM Balance in each Calendar Year [***] that is [***].

l. “Excess CPM Remaining Amount” shall mean any CPM Balance that [***].

(ii) Commercialization Expenses. The Parties shall share all Commercialization Expenses for Commercialization Activities that are incurred by the Parties in accordance with each Product Work Plan, according to the Profit Share Percentage.

(iii) Development and Commercialization Expense Overages. Each Party shall promptly notify the other Party if the notifying Party reasonably determines that it is likely to otherwise exceed its allocated Development Expenses or Commercialization Expenses under an applicable Product Work Plan, and such excess expenses shall be treated as follows. If a Party’s anticipated Development Expenses or Commercialization Expenses in any Calendar Quarter exceed those included in the development or [***] for all of such Party’s activities under the Product Work Plan in such Calendar Quarter by [***] (“Excess Further Expenses”), such Party shall provide the other Party an explanation and reasonable documentation of such Excess Further Expenses, and such Excess Further Expenses [***] by such Party shall be borne [***] by Momenta and [***] by Mylan; provided that such Excess Further Expenses [***], such Party [***] for such Calendar Year. If such Excess Further Expenses exceed those included in the Development or [***] for all of such Party’s activities under the applicable Product Work Plan for a Calendar Quarter by [***], the Parties shall [***]. The Excess Further Expenses mechanism is implemented as a tool to monitor and effectively manage quarterly variations in Development Expenses and Commercialization Expenses for timing differences. It does not [***]. If a Party determines or

anticipates that its projected Development Expenses or Commercialization Expenses will exceed those included in the Development or [***] for all of such Party’s activities under the applicable Product Work Plan for such Calendar Year, then such Party would need to [***], and the allocation of Development Expenses or Commercialization Expenses in excess of the previously approved budget in the Product Work Plan will be [***].

(iv) [***]. The Parties agree and intend that [***] shall not be included in Shared Other Expenses, except as expressly agreed by the Parties pursuant to the applicable Product Work Plan or otherwise by the Parties in writing. However, the Parties agree and intend that [***], shall be included in Shared Other Expenses. Subject to the foregoing, Each Party shall have the right to [***] for the Products as it deems necessary or appropriate.

(v) COGS. The Parties shall share all COGS incurred in connection with the Commercialization of the Product in accordance with each Product Work Plan, according to the Profit Share Percentage.

(vi) Legal Expenses. The Parties’ rights and responsibilities with respect to the Legal Activities, including the financial rights and obligations of the Parties, are described in Article 5 and Section 8.4.

(vii) Third Party Intellectual Property Payment Expenses. Neither Party shall, after the Effective Date, [***], without: (A) [***], and (B) [***]. Upon [***], the Parties [***], the Third Party Intellectual Property Payments (including, without limitation [***] payable to the licensor or seller of such Patent Rights and Know-How based on the Development, Manufacture or Commercialization of the Products by or on behalf of the Parties hereunder.

(viii) FTEs and FTE Costs. Each Party shall record and account for its FTE effort for the Development and Commercialization of Products to the extent that such FTE effort is included in Development Expenses or Commercialization Expenses that are, or may in the future be, shared under this Agreement. Each Party shall report such FTE effort to the JSC on a quarterly basis. Except to the extent provided herein, each Party shall calculate and maintain records of FTE effort incurred by it [***]. The JSC shall review the FTE Costs and any adjustments thereto annually as part of its review, update and approval of the Product Work Plans.

(b) Incurring and Reporting of Shared Other Expenses and Development Expenses; Summary Statements. Except as expressly provided otherwise in this Agreement and subject to [***] will be responsible for and pay for all such Shared Other Expenses so incurred. Each Party will maintain the books and records referred to in Section 4.3 and will accrue all Shared Other Expenses, Development Expenses and Net Sales in accordance [***] and [***]. Within ten (10) Business Days after the end of each calendar month, each Party will submit to the other Party a [***] of the Shared Other Expenses accrued, Development Expenses, and, if applicable, Net Sales during the just-ended calendar month. Within [***] after the end of each Calendar Quarter [***], each Party will submit to the other Party a written report reflecting the accrual of Shared Other Expenses, Development Expenses and Net Sales during the just-ended Calendar Quarter, as well as any Sublicense Revenue, on a Product-by-Product basis (each a “Summary Statement”). To the extent Momenta makes Net Sales pursuant to a Co-

Commercialization Agreement, it shall include the information described in Section 4.2(c)(i) - (ii) below in its Summary Statement for each applicable Calendar Quarter. Such Summary Statements shall [***] all expenses included in such Shared Other Expenses and Development Expenses during such Calendar Quarter and, upon the reasonable request of the other Party, shall be [***]. Each Party shall report the Shared Other Expenses and Development Expenses incurred by it in comparison to the Product Work Plan. The Parties shall seek to resolve any questions related to such Summary Statements within [***] following receipt by each Party of the other Party’s report hereunder. The JSC shall facilitate the resolution of any questions concerning such Summary Statements, as appropriate. Each Party shall have the right at reasonable times and upon reasonable prior notice to audit the other Party’s records as provided in Section 4.5 to confirm the accuracy of the other Party’s costs and reports with respect to Shared Other Expenses and Development Expenses that are shared under this Agreement. Upon the request of either Party [***], the JFC will discuss any questions or issues arising from the Summary Statements, including the basis for the accrual of specific Shared Other Expenses or Development Expenses.

(c) [***]. [***] after the end of the Calendar Quarter, but in any event within [***] after receipt by the Preparing Party (as defined below) of the other Party’s Summary Statement [***], the Preparing Party will prepare a [***] report [***] shall be [***] that [***] each Party’s Summary Statement and the Profits (Losses) and Legal Expenses [***] on a Product-by-Product basis in accordance with Section 4.2(a) (the “[***]”). Prior to [***] shall be the Preparing Party for [***] for such Product. Following [***] shall be the Preparing Party for [***] for such Product. Without limited the foregoing, following [***], the [***] shall include:

(i) [***];

(ii) [***];

(iii) [***];

(iv) [***]; and

(v) [***]. For clarity, to the extent [***].

(d) Payments of Cost Share and Profit Share.

(i) Based on the [***] for the applicable Calendar Quarter or Calendar Year, the applicable Party [***] will invoice the other Party after such [***] is complete, and the receiving Party will pay such invoice within [***] of receipt of invoice. For clarity, prior to [***], the sharing of expenses will be calculated in accordance with this Section 4.2 [***], and [***]. The Parties may, upon mutual agreement, net out payment of a Development Reconciliation Amount owed to one Party under Section 4.2(a)(i) with any payment owed to the other Party under this Section 4.2(d)(i).

(ii) Overdue Payments. If any payment owed to a Party under this Agreement is not made when due, such outstanding payment shall accrue interest (from the date such payment is due through and including the date upon which full payment is made) [***], from the due date until paid in full, provided that in no event shall said annual rate exceed the maximum interest rate permitted by law in regard to such payments. Such payment, when made,

shall be accompanied by all interest so accrued. Said interest and the payment and acceptance thereof shall not negate nor waive the right of a Party to any other remedy, legal or equitable, to which it is entitled because of the delinquency of the payment.

(e) Efforts to Streamline Reporting. The Parties will cooperate [***], through the JFC, to develop processes and align the reporting timelines set forth in Section 4.2(a), (b) and (c) with each Party’s internal close calendars and internal and external reporting timelines, processes and obligations.

4.3 Books and Records. During the Term of this Agreement, each Party shall keep, and shall ensure that its respective Affiliates and Sublicensees shall keep, [***], complete and accurate records in sufficient detail to make the reports required hereunder, to confirm compliance with the provisions of this Agreement, to properly reflect all amounts billed, owed or reported and to verify the amounts payable hereunder for a period of [***] after such payments are made.

4.4 Taxes.

(a) Tax Withholding. Each Party shall be entitled to deduct and withhold from any amounts payable under this Agreement such taxes as are required to be deducted or withheld therefrom under any provision of Applicable Law. The Party that is required to make such withholding (the “Paying Party”) will: (i) deduct those taxes from such payment, (ii) timely remit the taxes to the proper taxing authority, and (iii) send evidence of the obligation together with proof of tax payment to the recipient Party (the “Payee Party”) on a timely basis following that tax payment; provided, however, that before making any such deduction or withholding, the Paying Party shall give the Payee Party notice of the intention to make such deduction or withholding (such notice, which shall include the authority, basis and method of calculation for the proposed deduction or withholding, shall be given at least a reasonable period of time before such deduction or withholding is required, in order for such Payee Party to obtain reduction of or relief from such deduction or withholding). Each Party agrees to cooperate with the other Parties in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect to ensure that any amounts required to be withheld pursuant to this Section 4.4(a) are reduced in amount to the fullest extent permitted by Applicable Laws. In addition, the Parties shall cooperate in accordance with Applicable Laws to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes (“Indirect Taxes”)) in connection with this Agreement, as applicable.

(b) Tax [***]. Notwithstanding the foregoing, if: (i) any Party [***], (ii) as a result of such [***], such Party (or its assignee) is required by Applicable Law to [***], and (iii) such [***], then any such [***]. The obligation to [***] pursuant to the preceding sentence shall not apply, however, to the extent such [***]. Solely for purposes of this Section 4.4, a Party’s [***] shall include [***].

(c) Tax Documentation. Each Party has provided a properly completed and duly executed IRS Form W-9 or applicable Form W-8 to the other Party. Each Party and any other recipient of payments under this Agreement shall provide to the other Party, at the time or times reasonably requested by such other Parties or as required by Applicable Law, such properly completed and duly executed documentation (for example, IRS Forms W-8 or W-9) as

will permit payments made under this Agreement to be made without, or at a reduced rate of, withholding for taxes.

(d) [***].

(e) U.S. Tax Considerations. Mylan shall indemnify, defend and hold Momenta harmless from any and all liabilities, claims and losses with respect of U.S. federal, state or local income or withholding taxes attributable to any amounts payable to (or allocable to) Mylan under this Agreement.

(f) Cooperation. Mylan and Momenta shall [***] cooperate with each other to minimize any adverse tax consequences that may arise with regard to the transactions contemplated by this Agreement and related agreements.

4.5 Audits and Inspection. From and after the Effective Date, upon [***] from a Party, the other Party shall permit, and shall ensure that its Affiliates shall permit, an independent certified public accounting firm of recognized national standing, selected by the requesting Party [***], to have access to such Party’s (or their Affiliates) records maintained pursuant to Section 4.3, as may be reasonably necessary to verify the accuracy of any amounts reported, actually paid or payable under this Agreement for any year ending not more than [***] prior to the date of such request; provided that a Party’s records related to any given year shall not be subject to audit pursuant to this Section 4.5 [***]. The audited Party may require such accounting firm to be subject to reasonable and customary confidentiality obligations as a condition to conducting such audit. Such audits may be made no more than [***], during normal business hours at reasonable times mutually agreed by the Parties; [***]. If such accounting firm concludes that additional amounts were owed to the requesting Party during such period with respect to such country of the Territory as applicable, or if the requesting Party overpaid based on a calculation of the Profit Share, the Development Reconciliation Amount or Legal Expenses not included in the calculation of the Profit Share during the audited period, the other Party shall pay such additional amounts or refund such overpayment (including interest on such additional sums with respect to such country of the Territory in accordance with Section 4.2(d)(ii)) within [***] after the date the requesting Party delivers to the other Party such accounting firm’s written report so concluding. If such accounting firm concludes that additional amounts were owed to the audited Party during such period with respect to such country of the Territory as applicable, or if the audited Party overpaid based on a calculation of the Profit Share, the Development Reconciliation Amount or Legal Expenses not included in the calculation of the Profit Share during the audited period, the auditing Party shall pay such additional amounts or refund such overpayment (including interest on such additional sums with respect to such country of the Territory in accordance with Section 4.2(d)(ii)) within [***] after the date the requesting Party delivers to the other Party such accounting firm’s written report so concluding. The fees charged by such accounting firm shall be paid by the requesting Party; provided, however, that if the audit discloses that the amounts payable to such Party for the audited period are more than [***] of the amounts actually paid for such period in such country of the Territory as applicable, or if the audit discloses that the other Party has overcharged the requesting Party for rates or fees for products or services for such period in such country of the Territory as applicable, by over [***], then the other Party shall pay the reasonable fees and expenses charged by such accounting firm.

ARTICLE 5.

INTELLECTUAL PROPERTY AND LITIGATION

5.1 Ownership of Intellectual Property. Mylan shall own and retain all right, title, interest and ownership in Mylan Intellectual Property, including Mylan Intellectual Property that was conceived, derived, acquired or made prior to the Effective Date or independently outside the course of the Collaboration, except as expressly licensed to Momenta under this Agreement. Momenta shall own and retain all right, title, interest and ownership in the Momenta Intellectual Property, including Momenta Intellectual Property that was conceived, derived, acquired or made prior to the Effective Date or independently outside the course of the Collaboration, except as expressly licensed to Mylan under this Agreement. The Parties shall jointly own all Collaboration Intellectual Property developed in the course of performing their activities under the Product Work Plan under the Collaboration. Subject [***], each Party [***].

5.2 Improvements. Mylan shall own all right, title, interest and ownership in and to Mylan Improvements created in the course of the Collaboration. Momenta shall own all right, title, interest and ownership in and to the Momenta Improvements created in the course of the Collaboration.

5.3 Prosecution and Maintenance of Patent Rights.

(a) Generally. From and after the Effective Date:

(i) [***] shall have the right and responsibility, [***], to prepare, file, prosecute (including the handling of inter partes review, post grant review, ex parte reexamination, supplemental examination, opposition and similar proceedings [***] and maintain patent protection [***]. If [***] decides to abandon, or otherwise fails to prosecute or maintain, any Patent Rights within the [***] in any country in the Territory, [***] shall provide [***] with written notice of such decision at least [***] prior to any applicable filing deadline, and of any such failure promptly after it occurs. In such case, [***] shall have the right, but not the obligation, to prepare, file, prosecute and maintain patent protection with respect to such [***] in such country [***]. Furthermore, subject to the terms and conditions of this Agreement, [***].

(ii) [***] shall have the right and responsibility, [***], to prepare, file, prosecute (including the handling of inter partes review, post grant review, ex parte reexamination, supplemental examination, opposition and similar proceedings with respect to the [***]) and maintain patent protection with respect to the [***] shall keep [***]. If Momenta decides to abandon, or otherwise fails to prosecute or maintain, any Patent Rights within the [***] in any country in the Territory, [***] shall provide [***] with written notice of such decision at least [***] prior to any applicable filing deadline, and of any such failure promptly after it occurs. In such case, [***] shall have the right, but not the obligation, to prepare, file, prosecute and maintain patent protection with respect to such [***] in such country [***]. Furthermore, subject to the terms and conditions of this Agreement, [***].

(iii) [***] shall have the responsibility to prepare, file, prosecute (including the handling of inter partes review, post grant review, ex parte reexamination, supplemental examination, opposition and similar proceedings with respect to the Collaboration

Patent Rights) and maintain patent protection with respect to Collaboration Patent Rights in the names of both Parties. [***] for the Collaboration Patent Rights, [***] with respect to the preparation, filing, prosecution (including the handling of inter partes review, post grant review, ex parte reexamination, supplemental examination, opposition and similar proceedings with respect to the Collaboration Patent Rights) and maintenance of the Collaboration Patent Rights. [***] for the Collaboration Patent Rights, [***] with respect to the preparation, filing, prosecution (including the handling of inter partes review, post grant review, ex parte reexamination, supplemental examination, opposition and similar proceedings with respect to the Collaboration Patent Rights) and maintenance of the Collaboration Patent Rights. The non-controlling Party shall cooperate as reasonably requested by Party assuming control to facilitate control of such filing, prosecution and maintenance of such Collaboration Patent Right by the Party assuming control.

(b) Cooperation. From and after the Effective Date, each Party shall make available to the Party filing, prosecuting or maintaining any Collaboration Patent Rights, or such Party’s authorized attorneys, agents or representatives, its employees whom such controlling Party [***] deems necessary in order to assist it in obtaining patent protection for such Collaboration Patent Rights.

(c) Responsibility for Legal Expenses. From and after the Effective Date, responsibility for Legal Expenses associated with patent prosecution (including the handling of inter partes review, post grant review, ex parte reexamination, supplemental examination, opposition and similar proceedings) and maintenance shall be as follows:

(i) Momenta Patent Rights/Mylan Patent Rights. Each Party shall be responsible for [***] of the Legal Expenses associated with the preparation, filing, prosecution and maintenance of the Patent Rights [***], in each case that cover or claim Products during the Term; provided that in the event that: (A) Momenta [***], Mylan’s responsibility with respect to Legal Expenses associated with such Patent Rights shall [***]; and (B) Mylan [***], Momenta’s responsibility with respect to Legal Expenses associated with such Patent Rights shall [***].

(ii) Collaboration Patent Rights. Each Party shall be responsible for [***] of the Legal Expenses associated with the preparation, filing, prosecution and maintenance of Collaboration Patent Rights during the Term.

5.4 Patent Enforcement/Third Party Infringement.

(a) Notice. Each Party shall promptly report to the other Party during the Term after the Effective Date any known or suspected infringement or unauthorized use of any of the Mylan Intellectual Property, the Momenta Intellectual Property or the Collaboration Intellectual Property, as the case may be, of which such Party becomes aware, and, upon request, shall provide the other Party with all evidence within its possession or control supporting such known or suspected infringement or unauthorized use.

(b) [***]. Promptly following notification to the other Party of any known or suspected infringement or unauthorized use of any of the Mylan Intellectual Property, the Momenta Intellectual Property or Collaboration Intellectual Property based on the Development,

Manufacture, or Commercialization of a Product or a Competing Product, [***] with respect to enforcement proceedings or Third Party infringement litigation matter [***] with respect to such infringement or unauthorized use (“Enforcement Litigation”); and (ii) [***].

(i) If the Parties, [***], agree to proceed with an Enforcement Litigation, [***] should take the lead in managing such Enforcement Litigation (such lead Party, the “Lead EL Party” and the other Party the “Non-EL Lead Party”) unless the Parties [***] determine that the JLC should manage such Enforcement Litigation.

(ii) The Parties will engage counsel [***]. The Lead EL Party, or the JLC when selected to manage the Enforcement Litigation, shall have the right to control the Enforcement Litigation, and the Non-EL Lead Party shall [***]. When a Lead EL Party is controlling a matter, [***].

(iii) The Parties and their counsel shall [***]. Counsel to the Parties shall [***]. When a Lead EL Party is controlling a matter, it shall [***] with regard to claims, arguments and strategy in the Enforcement Litigation; provided, however, that [***], then the Lead EL Party shall [***].

(iv) All Legal Expenses related to an Enforcement Litigation matter [***] with respect to a Product [***] and any recoveries obtained as a result of such Enforcement Litigation shall be allocated between the Parties in accordance with their respective Allocable Legal Expense Shares. Further, for the avoidance of doubt, [***].

(d) [***] Enforcement Litigation.

(i) [***], shall have the right to determine whether or not to proceed with any Enforcement Litigation. If such party determines to proceed with the Enforcement Litigation, such Party (hereinafter the “Active EL Party”) shall have the sole and exclusive right to select counsel for the Enforcement Litigation initiated by it pursuant to this Section 5.4(d). The Party that is not the Active EL Party shall be referred to under this Section 5.4(d) as the “Passive EL Party”.

(ii) In any Enforcement Litigation brought by the Active EL Party pursuant to this Section 5.4(d), the Passive EL Party [***]; but control of such Enforcement Litigation shall remain with the Active EL Party.

(iii) All Legal Expenses related to an Enforcement Litigation matter [***] with respect to a Product [***] and any recoveries obtained as a result of such Enforcement Litigation shall be allocated between the Parties as follows:

(1) The Active EL Party shall be responsible for and shall pay [***] of all Legal Expenses (other than [***]) associated with such Enforcement Litigation, subject to the following.

(2) If the Enforcement Litigation pursued by the Active EL Party [***], based on [***], any recoveries obtained as a result of such Enforcement Litigation

shall be allocated to the Parties in accordance with their respective Allocable Legal Expense Share; provided that the Active EL Party [***]. If such Enforcement Litigation matter [***] following the final, unappealable (or unappealed) court order or decision, or final settlement of the Enforcement Litigation for such Product in such country. [***].

5.5 [***]; Third Party Suits.

(a) [***]. Within [***] after the creation of the JLC, the JLC [***] taking into consideration [***] (the “Collaboration IP Plan”). The Collaboration IP Plan shall [***] (“Legal Clearance Activities”). The Collaboration IP Plan shall [***]. The JSC shall meet and seek to agree at least [***] prior to the filing of a BLA for Regulatory Approval of a Product as to the appropriate course of action with respect to Legal Clearance Activities with respect to each Product. Decisions regarding the appropriate course of action with respect to Legal Clearance Activities [***].

(b) Third Party Suits; Other Collaboration Litigation.

(i) In addition, from and after the Effective Date, in the event that a Third Party shall otherwise make any claim or bring any suit or other proceeding (including a declaratory judgment) against a Party, or any of its Affiliates, Sublicensees, or customers, for infringement or misappropriation of any intellectual property rights based on the research, development, making, using selling, offering for sale, import or export of any Product in the Territory, [***].

(ii) [***]. In connection therewith, [***].

(i) If, after the Effective Date, the Parties: (A) pursuant to the Collaboration IP Plan, or otherwise [***]; (B) [***]; or (C) [***], in each case unless the Parties [***] determine that [***] (such lead Party, the “Lead OCL Party” and the other Party, the “Non-Lead OCL Party”).

(ii) [***].

(iii) The Parties and their counsel shall [***]. Counsel to the Parties shall also [***]. Each Party shall [***]; however, if [***]. All Legal Expenses related to an Other Collaboration Litigation matter described in Section 5.5(c)(i) with respect to a Product and any recoveries obtained as a result of such Other Collaboration Litigation shall be allocated between the Parties in accordance with their respective Allocable Legal Expense Shares.

(d) [***] Other Collaboration Litigation. Other than as permitted under Section 2.4(f), if, after the Effective Date, [***]; or (B) [***], in each case within [***] following notification to the other Party of [***], the Parties shall [***].

5.6 Settlement. After the Effective Date, [***] may settle or consent to an adverse judgment with respect to an Enforcement Litigation or Other Collaboration Litigation which [***]. However, [***].

5.7 [***] Litigation. [***] on the appropriate course of action with respect to [***] proceedings and litigation related to the Products. All Legal Expenses associated with actions with respect to [***] proceedings that are included in the Collaboration IP Plan [***] shall be allocated according to the Parties’ respective Allocable Legal Expense Shares.

5.8 Patent Marking. Mylan shall be responsible for complying with patent marking statutes in the applicable country in the Territory in which a Product is sold by Mylan, its Affiliates or its Sublicensees pursuant to this Agreement.

5.9 Participation of Other Persons in the Collaboration. Except as the Parties may otherwise agree in writing, each of Mylan and Momenta shall be responsible for executing an appropriate agreement with each employee, individual contractor, consultant or agent (including, for purposes of clarity, individuals who regularly work for Affiliates of Mylan or Momenta), as well as Third Parties working on their respective behalves on the Collaboration, including a provision requiring such employee, individual contractor, consultant, agent, or Third Party to assign or exclusively license to Mylan or Momenta, respectively, all Know-How and Patent Rights which he or she develops or conceives or reduces to practice in the course of his or her Development work on the Collaboration that Cover the Products, so that such Know-How and Patent Rights are Controlled by Mylan or Momenta, respectively. Each Party shall [***] to enforce the terms of their respective agreements described in this Section 5.9. Upon written request, each Party shall make available to the other Party copies of any material agreements with contractors or other Third Parties with respect to Third Party Intellectual Property Payments authorized by the JSC under Section 4.2(a)(vii), to the extent permitted by such agreements and subject to appropriate confidentiality obligations.

5.10 Common Interest Disclosures. With regard to any privileged or confidential information or opinions disclosed pursuant to this Agreement by a Party to the other Party regarding Patent Rights or other intellectual property or technology owned by the disclosing Party or a Third Party, the Parties agree that they may have a common legal interest in determining whether, and to what extent, such Patent Rights and other intellectual property rights may affect any Product, and a further common legal interest in defending against any actual or prospective Third Party claims based on allegations of misuse or infringement of Patent Rights or other intellectual property rights relating to any Product. Accordingly, the Parties agree that all such information and materials obtained by Mylan and Momenta from each other in which they have such a common legal interest may be subject to a separate common interest agreement mutually acceptable to the Parties that they may enter into with respect to such information and materials, upon the request of either Party. Such separate agreement would provide that: (a) all such information and materials [***]; (b) [***]; and (c) [***].

5.11 Identification of the Parties as a Co-Developer of each Product.

(a) During the Term after the Effective Date, Mylan shall ensure that the primary packaging artwork and label (but not marketing materials) that are used for Commercializing each Product in each country in the Territory clearly [***].

(b) Subject to the terms and conditions of this Agreement, Momenta hereby grants Mylan, during the Term after the Effective Date, a non-exclusive and royalty-free license in the Territory to use [***] solely in connection with the Products

for the purpose of packaging, labeling, marketing, distribution and sale of the Products. Mylan acknowledges and agrees that: (i) the [***] are and shall remain the sole property of Momenta; (ii) its utilization of the [***] will not create in it, nor will it represent it has, any right, title or interest in or to such [***] other than the license expressly granted herein; and (iii) all goodwill attached to or arising out of such use of the [***] by Mylan will accrue to the benefit of Momenta. Mylan agrees that it will take no action adverse to or inconsistent with Momenta’s ownership of the [***], including without limitation seeking to register any of the [***] in the Territory, or opposing, disputing, or assisting others in opposing or disputing Momenta’s ownership of the [***] in any way.

(c) Mylan acknowledges the importance to Momenta of maintaining the reputation and goodwill associated with the [***] and high standards of quality for any products and services provided in connection with the [***]. Mylan agrees that its use of the [***] shall conform to Applicable Law and to reasonable and customary usage guidelines and quality standards communicated in writing by Momenta to Mylan. Mylan shall use the [***] upon or in relation to the Products only in such manner where the distinctiveness, reputation, and validity of the [***] shall not be impaired and the public shall not be misled. If Mylan fails to comply with the terms of this Section 5.11(c), then [***].

(d) Mylan shall provide representative packaging artwork and labels or marketing material that Mylan wishes to use for the Commercialization of a Product for Momenta’s review. Momenta shall notify Mylan in writing of any change to any packaging or labeling used for a Product necessary to reflect any changes to Momenta’s trademark, trade name, logo or other features thereof, and Mylan shall promptly incorporate such change in the next revision of such packaging or labeling. Except as set forth above, after the Effective Date, Mylan shall have the sole right to select the trademarks and trade dress for use with the Products in the Territory, and, as between the Parties, Mylan shall own all such trademarks and trade dress, and all good will associated therewith.

ARTICLE 6.
LICENSES AND EXCLUSIVITY

6.1 Licenses to Mylan.

(a) Product Specific Licenses. Subject to the terms and conditions of this Agreement, Momenta hereby grants to Mylan, effective as of the Effective Date, an exclusive (even as to Momenta, except as expressly set forth below in this Section 6.1(a)) right and license, with the right to grant and authorize sublicenses [***], under the Momenta Intellectual Property and Momenta’s interest in the Collaboration Intellectual Property to: (i) Develop, Manufacture (and have made), use, and import the Products; and (ii) sell, offer for sale, have sold and otherwise Commercialize the Products, in each case (i) and (ii) in the Field in the Territory; provided that Momenta shall retain any rights under the Momenta Intellectual Property and Collaboration Intellectual Property necessary to perform any Development Activities or

Commercialization Activities assigned to it with respect to a Product in a Product Work Plan or Co-Commercialization Agreement, as applicable.

(b) Covenant. Mylan shall use such Momenta Intellectual Property solely for the purposes of exercising its rights and performing its obligations under this Agreement and solely as otherwise permitted under Applicable Law.

6.2 Licenses to Momenta.

(a) Collaboration License. Subject to the terms and conditions of this Agreement, Mylan hereby grants to Momenta, effective as of the Effective Date, a co-exclusive (with Mylan), non-transferable, right and license, in the Field in the Territory, with the right to grant sublicenses solely as agreed to by the Parties [***], under the Mylan Intellectual Property solely to: (i) perform its activities under the applicable Product Work Plan(s) to Develop and Manufacture the Products; and (ii) to the extent Momenta has rights to Commercialize the Products pursuant to Section 2.7 to perform its activities under the applicable Commercialization Plan and Co-Commercialization Agreement.

(b) Covenant. Momenta shall use such Mylan Intellectual Property solely for the purposes of exercising its rights and performing its obligations under this Agreement and solely as otherwise permitted under Applicable Law.

6.3 In-Licensed Technology. After the Effective Date, if either Party, its Affiliates, or Sublicensees identify the need for, or are otherwise offered, a license, covenant not to sue or similar rights to Third Party Patent Rights or Know-How that such Party or its Affiliates [***] believes are (a) [***] or (b) [***].

6.4 Retained Rights. Any rights of Momenta not expressly granted to Mylan under the provisions of this Agreement shall be retained by Momenta and any rights of Mylan not expressly granted to Momenta under the provisions of this Agreement shall be retained by Mylan.

6.5 Exclusive Collaboration.

(a) Competing Products. During the Term after the Effective Date, with respect to each Product, Momenta and Mylan each agree, respectively, that they shall not, and shall ensure that their respective Affiliates shall not develop (except to the extent permitted by Section 6.5(b)), manufacture or commercialize, or enable any Third Party to develop, manufacture or commercialize, in the Territory a Competing Product that is not a Product that is Developed, Manufactured or Commercialized by the Parties pursuant to this Agreement. Should a Party fail to comply with this Section 6.5, the other Party may terminate the Agreement on a Product-by-Product and country-by-country basis pursuant to Section 10.3(a), in addition to any other remedies available to it under this Agreement, in law or in equity.

(b) Acquisition of Competing Product Pursuant to Merger or Acquisition. Neither Party will be deemed to be in breach of the restrictions set forth in this Section 6.5 if such Party or any of its Affiliates acquires a Competing Product, or the right to develop, manufacture or commercialize a Competing Product in a country(ies) in the Territory, through an acquisition of or a merger with the whole or substantially the whole of the business or assets of

another Person, so long as such Party (or its Affiliate) notifies the other Party in writing within [***] after the closing of such acquisition or merger and:

(i) enters into a definitive agreement with a Third Party to Divest such Competing Product in the applicable country(ies) in the Territory (including as part of any Hold Separate Transaction) within [***] (or such longer period that is required under Applicable Law) after the closing of such acquisition or merger, [***]; or

(ii) discontinues the development and commercialization of the Competing Product in the Territory no later than [***] (or such longer period that is required under Applicable Law) after the closing of such acquisition or merger, [***].

[***] Acquisition of Competing Product other than Pursuant to Section 6.5(b). In the event that, after the Effective Date, a Party (the “Acquiring Party”) acquires a Competing Product or in-licenses the right to develop, manufacture and commercialize a Competing Product in a country(ies) in the Territory, other than pursuant to an acquisition described in Section 6.5(b), the Acquiring Party shall notify the other Party within [***] after the closing of such acquisition as to whether it intends to: (1) [***]; (2) [***]; (3) terminate [***]; or (4) [***]. In the event that the Acquiring Party fails to provide such notice within the applicable [***] period, the Acquiring Party shall be deemed to have provided notice of a decision to [***]. For clarity, the effective date of a termination under item (3) shall be [***]. For further clarity, until such effective date of termination, the [***]. Termination of this Agreement pursuant to item (3) under this [***] shall [***].

(d) Additional [***] Activities.

(i) If, after the Effective Date, a Party wishes to conduct [***] with respect to a Product that [***] (“Additional [***] Activities”), then such proposing Party shall provide the JSC (or applicable Sub-Committee) with [***]. If the JSC approves such Additional [***] Activities, then such Additional [***] Activities shall be incorporated into the existing Product Work Plan, and the costs of such Additional [***] Activities shall be shared by the Parties as Development Expenses pursuant to Sections 4.2(a)(i). If the JSC does not approve such Additional [***] Activities, then [***].

(ii) Additional [***] Intellectual Property. Any Know-How or Patent Rights arising in the performance of any such Additional [***] Activities proposed to but not approved by the JSC and conducted independently by a Party shall not be included within such Party’s Intellectual Property (i.e., Momenta Intellectual Property or Mylan Intellectual Property, as applicable) for purposes of licenses granted to the other Party under this Agreement, and shall not be used for the Development, Manufacture or Commercialization of any Products under this Collaboration (unless the Parties agrees in writing to the use of such Know-How or Patent Rights). In connection with such agreement, the Parties will negotiate terms for such Know-How or Patent Rights to be included within such Party’s Intellectual Property (i.e., Momenta Intellectual Property or Mylan Intellectual Property, as applicable) for purposes of licenses granted to the other Party under this Agreement. For clarity, exploitation of such Know-How and Patent Rights shall remain subject to the restrictions set forth in Section 6.5(a).

6.6 No Additional Licenses. Except as expressly provided in this Agreement, nothing in this Agreement grants either Party any right, license, title or interest in and to the intellectual property rights of the other Party (either expressly, by implication or by estoppel).

6.7 Bankruptcy. All rights and licenses granted under or pursuant to any Section of this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11, United States Code (the “Bankruptcy Code”), licenses of rights to “intellectual property” as defined under Section 101(35A) of the U.S. Bankruptcy Code. The Parties shall retain and may fully exercise all of their respective rights and elections under the U.S. Bankruptcy Code. Upon the bankruptcy of a Party, the non-bankrupt Party shall further be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property necessary to exercise such rights and licenses, and such, if not already in its possession, shall be promptly delivered to the non-bankrupt Party, unless the bankrupt Party elects to continue, and continues, to perform all of its obligations under this Agreement.

ARTICLE 7.

CONFIDENTIAL INFORMATION

7.1 Confidentiality. Except as expressly contemplated by this Agreement or any agreement between the Parties that is ancillary hereto, each Party shall hold in confidence and shall not publish or otherwise disclose and shall not use for any purpose (except for the purposes of carrying out its obligations or exercising its rights under this Agreement): (a) any Confidential Information of the other Party disclosed to it pursuant to this Agreement and (b) the terms of this Agreement (subject to Section 7.4), until [***] after the expiration or termination of this Agreement. The members of the JSC and any Sub-Committees shall use pricing and other competitive commercial information provided by the other Party solely for purposes of the Collaboration and Commercializing the Products in accordance with this Agreement. All Confidential Information of a Party, including all copies and derivations thereof, is and shall remain the sole and exclusive property of the disclosing Party and subject to the restrictions provided for herein. Subject to Section 7.2, Section 7.3, Section 7.4 and Section 7.5, neither Party shall disclose any Confidential Information of the other Party other than to those of its directors, officers, Affiliates, employees, independent contractors, [***], agents, and external advisors directly involved in or concerned with the carrying out of this Agreement, on a strictly applied “need to know” basis [***]; provided, however, that such persons and entities are subject to confidentiality and non-use obligations at least as stringent as the confidentiality and non-use obligations provided for in this Article 7, [***].

7.2 Public Disclosure. The Parties have attached hereto as Exhibit 7.2, mutually acceptable press releases by each Party announcing the Collaboration (the “Initial Press Releases”), which each Party will release at a time to be mutually agreed by the Parties. The JSC shall review and approve, from time to time, proposed disclosures of the Parties relating to this Collaboration (or related activities, results or events) [***]. Except: (a) as determined by a Party [***] to comply with Applicable Law (including applicable securities laws and the rules and regulations of exchanges upon which a Party’s securities are traded), subject to this Section 7.2; (b) with respect to JSC approved disclosures; and (c) with respect to the Initial Press Releases as agreed upon between the Parties, neither Party shall issue a press release or make any other public disclosure regarding the terms or existence of this Agreement or the Collaboration without the prior approval of such press release or public disclosure by the other

Party. Each Party shall submit any such press release or public disclosure to the other Party, and the receiving Party shall have [***] from receipt to review and approve any such press release or public disclosure, [***]. Notwithstanding the preceding requirements related to a press release or other public disclosure, if a public disclosure is required by Applicable Law, including without limitation in a filing with the U.S. Securities and Exchange Commission, the disclosing Party shall provide copies of the disclosure reasonably in advance [***] of such filing or other disclosure for the non-disclosing Party’s prior review and comment. The first approval of the contents of a press release or public disclosure shall constitute permission to use such contents subsequently without submission of the press release or public disclosure to the other Party for approval.

7.3 Legally Required Disclosures. If the receiving Party or any of its representatives is required by Applicable Law or by order of a court of law, administrative agency, or other governmental body to disclose any of the Confidential Information of the other Party, the receiving Party will (a) promptly provide the disclosing Party with reasonable advance written notice to enable the disclosing Party the opportunity to seek, where appropriate, a protective order or to otherwise prevent or limit such legally required disclosure, (b) [***] cooperate with the disclosing Party to obtain such protection, and (c) disclose only the legally required portion of the Confidential Information. Any such legally required disclosure will not relieve the receiving Party from its obligations under this Agreement to otherwise limit the disclosure and use of such information as Confidential Information.

7.4 Confidential Terms. Except as expressly provided herein, each Party agrees not to disclose the existence or any terms of this Agreement to any Third Party without the consent of the other Party; provided, however, that disclosures may be made on a strict need to know basis to actual or prospective investors, acquirers, financing sources or licensees, or to a Party’s accountants, attorneys and other professional advisors, [***] of confidentiality. If this Agreement must be publicly filed to comply with Applicable Laws or regulations or rules of a securities exchange, including as required in connection with a public offering of a Party’s stock or to comply with regulations imposed by the United States Securities and Exchange Commission, NASDAQ or stock exchange disclosure requirements, then the Party filing the Agreement shall use reasonable efforts to seek confidential treatment of the Agreement and shall seek the review and comment of the other Party with respect to proposed redactions.

7.5 [***]. With respect to a Product, each of the Parties agrees to share, upon request, [***] with the other Party and its Affiliates and Sublicensees [***], provided, however, that [***] shall be used by the receiving Party and its Affiliates and Sublicensees solely for [***]. Except as set forth in the preceding sentence, if an Affiliate or Sublicensee of a Party shall fail to agree to [***] to the extent such Affiliate or Sublicensee’s [***], such Affiliate or Sublicensee, as the case may be, shall not be entitled to receive [***]. Each Party agrees [***] with regard to a Product or any [***] with regard to a Product as the other Party believes may be useful or necessary for it to [***], in accordance with the terms of this Agreement.

7.6 Publications. Each Party shall submit to the JSC for review and approval all proposed academic, scientific and medical publications and public presentations relating to a Product or any Development Activities under this Agreement for review in connection with preservation of related patent rights, and trade secrets to determine whether Confidential Information should be modified or deleted from the proposed publication or public presentation

and to ensure compliance with the publications policy adopted by the JSC (the “Publications Policy”). Written copies of such proposed publications and presentations shall be submitted to the JSC no later than [***] before submission for publication or presentation and the JSC shall provide its comments with respect to such publications and presentations within [***] of its receipt of such written copy. The review period may be extended for an additional [***] if a representative of the non-publishing Party on the JSC can demonstrate a reasonable need for such extension including, but not limited to, the preparation and filing of patent applications. By mutual agreement of the Parties, this period may be further extended. The first approval of the contents of a proposed academic, scientific or medical publication or public presentation relating to a Product or any Development Activities under this Agreement shall, in each case, constitute permission to use such contents subsequently without submission to the other Party for approval.

7.7 Prior Confidentiality Agreements. The Parties are parties to a [***] (the “Prior Confidentiality Agreement”). This Agreement, including this Article 7, shall supersede the Prior Confidentiality Agreement. All Confidential Information (as that term is defined in the Prior Confidentiality Agreement) disclosed pursuant to the Prior Confidentiality Agreement shall be considered Confidential Information under this Agreement, subject to the exceptions in Section 1.30.

7.8 Destruction of Confidential Information. Each Party shall destroy, at the other Party’s instruction, all Confidential Information of the other Party in its possession upon termination or expiration of this Agreement, or at the disclosing Party’s election and written request. The receiving Party shall provide a written confirmation of such destruction within [***] after such destruction; provided that the foregoing shall not apply to any Confidential Information that is necessary to allow such Party to perform its obligations or exercise any of its rights that expressly survive the termination or expiration of this Agreement, and each Party shall be permitted to retain one copy of all Confidential Information for purposes of determining its obligations under this Agreement.

ARTICLE 8.

INDEMNIFICATION AND LIMITATION OF LIABILITY

8.1 Mylan Indemnification. Mylan agrees to defend the [***], at Mylan’s cost and expense, and will indemnify and hold harmless the [***] from and against Losses arising or resulting from any Claims against a [***] arising or resulting from the Fault of Mylan or its Affiliates. Mylan’s obligation to indemnify the [***] pursuant to this Section 8.1 for the Fault of Mylan shall be subject to apportionment in accordance with Section 8.3. As used herein, for the avoidance of doubt, Mylan’s obligation to indemnify the [***] pursuant to this Section 8.1 shall not apply to any Enforcement Litigation or Other Collaboration Litigation, and the Parties’ respective rights and obligations with respect to any such Enforcement Litigation or Other Collaboration Litigation shall be governed exclusively by Article 5. If any such Claim against any [***] arises, Momenta shall promptly notify Mylan in writing of the Claim and Mylan shall manage and control, at its sole expense, the defense of the Claim and its settlement. Notwithstanding the foregoing, no settlements shall be finalized with respect to such Claim without obtaining Momenta’s prior written consent, [***], except that in the case of a settlement that does not require an admission or action on the part of Momenta, and does not harm Momenta or its ability to comply with its obligations hereunder, Momenta’s consent shall

not be required so long as Momenta is unconditionally released from all liability in such settlement. Momenta shall cooperate with Mylan and may, [***], be represented in any such action or proceeding. Mylan shall not be liable for any settlements, litigation costs or expenses incurred, or admissions made, by [***] without Mylan’s written authorization.

8.2 Momenta Indemnification. Momenta agrees to defend Mylan and its Affiliates, and their respective agents, directors, officers and employees (the “Mylan Indemnitees”), at Momenta’s cost and expense, and will indemnify and hold harmless the Mylan Indemnitees from and against Losses arising or resulting from any Claims against a Mylan Indemnitee arising or resulting from the Fault of Momenta or its Affiliates. Momenta’s obligation to indemnify the Mylan Indemnitees pursuant to this Section 8.2 for the Fault of Momenta shall be subject to apportionment in accordance with Section 8.3. For the avoidance of doubt, Momenta’s obligation to indemnify the Mylan Indemnitees pursuant to this Section 8.2 shall not apply to any Enforcement Litigation or other Collaboration Litigation, and the Parties’ respective rights and obligations with respect to any such Enforcement Litigation or other Collaboration Litigation shall be governed exclusively by Article 5. If any such Claim against any Mylan Indemnitee arises, Mylan shall promptly notify Momenta in writing of the Claim, and Momenta shall manage and control, at its sole expense, the defense of the Claim and its settlement. Notwithstanding the foregoing, no settlements shall be finalized with respect to such Claim without obtaining Mylan’s prior written consent, [***], except that in the case of a settlement that does not require an admission or action on the part of Mylan, and does not harm Mylan or its ability to comply with its obligations hereunder, Mylan’s consent shall not be required so long as Mylan is unconditionally released from all liability in such settlement. Mylan shall cooperate with Momenta and may, [***], be represented in any such action or proceeding. Momenta shall not be liable for any settlements, litigation costs or expenses incurred, or admissions made, by Mylan Indemnitees without Momenta’s written authorization.

8.3 Apportionment. If any Losses are indemnifiable pursuant to both Section 8.1 and Section 8.2 by reason of or result from the joint Fault of Mylan and Momenta for such Losses, then such Losses shall be [***].

8.4 Other Claims. In the event of any Claims that result in Losses being incurred by any Mylan Indemnitee or any [***], where such Claims and associated Losses: (a) are not within the indemnification obligations described in Section 2.4(f)(v)(4), Section 8.1 or Section 8.2; (b) do not arise or result from the Fault of a Party or its Affiliates; and (c) arise as a result of the Development, Manufacture or Commercialization activities conducted by either Party on or after the Effective Date with respect to any Product in the Territory, each Party shall be responsible for its Allocable Legal Expense Share of such Losses, regardless of which Party’s indemnitees initially bear such Losses. Appropriate indemnification or reimbursement shall be made by the Party bearing less than its Allocable Legal Expense Share to the other Party to effect the foregoing allocation of applicable Losses. If any such Claim arises, the Party against which (or against whose indemnitees) such Claim is brought shall promptly notify the other Party in writing of the Claim, [***] shall manage and control the defense of such Claim and its settlement (the “Defending Party”). [***]. Notwithstanding the foregoing, no settlements shall be finalized without obtaining the other Party’s (the “Non-Defending Party”) prior written consent, [***], except that in the case of a settlement that does not require an admission or action on the part of the Non-Defending Party, and does not harm the Non-Defending Party or its ability to comply with its obligations hereunder, the Non-Defending Party’s consent shall not be required

so long as it is unconditionally released from all liability in such settlement. The Non-Defending Party shall cooperate with Defending Party and may, [***], be represented in any such action or proceeding.

8.5 Insurance. Each Party shall maintain insurance [***], including product liability insurance, with respect to its activities under this Agreement. Such insurance [***] shall be in such amounts and subject to such deductibles as are prevailing in the industry from time to time; provided that, each Party shall maintain a minimum of an aggregate of [***] in general comprehensive liability insurance and an aggregate of: (a) [***] in product liability insurance [***] and (b) [***] in product liability insurance no later than [***]. Each Party shall provide written proof of the existence of such insurance to the other Party upon request. For clarity, [***]. Further, each Party sponsoring any clinical trials of the Products shall maintain clinical trial insurance that is in compliance with the local laws of each country in which such clinical trials are being completed.

8.6 No Consequential Damages. UNLESS RESULTING FROM A PARTY’S FRAUD OR FROM A PARTY’S BREACH OF SECTION 6.5 OR ARTICLE 7, NO PARTY WILL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, PUNITIVE, MULTIPLE OR OTHER INDIRECT DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, OR FOR LOSS OF PROFITS, LOSS OF DATA OR LOSS OF USE DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT WHETHER BASED UPON WARRANTY, CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 8.6 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER THIS AGREEMENT.

ARTICLE 9.

EXPORT

9.1 General. The Parties acknowledge that the exportation from the U.S. of materials, products and related technical data (and the re-export from elsewhere of U.S. origin items) may be subject to compliance with U.S. export laws, including without limitation the U.S. Bureau of Export Administration’s Export Administration Regulations, the Federal Food, Drug and Cosmetic Act and regulations of the FDA issued thereunder, and the U.S. Department of State’s International Traffic and Arms Regulations which restrict export, re-export, and release of materials, products and their related technical data, and the direct products of such technical data. The Parties agree to comply with all exports laws and to commit no act that, directly or indirectly, would violate any U.S. law, regulation, or treaty, or any other international treaty or agreement, relating to the export, re-export, or release of any materials, products or their related technical data to which the U.S. adheres or with which the U.S. complies.

9.2 Delays. The Parties acknowledge that they are not responsible for any delays attributable to export controls that are beyond the reasonable control of either Party.

9.3 Assistance. The Parties agree to provide assistance to one another in connection with each Party’s efforts to fulfill its obligations under this Article 9, at the reasonable request and expense of the Party receiving such assistance.

9.4 Other. The Parties agree not to export, re-export, or release any item that may be used in the design, development, production, stockpiling or use of chemical or biological weapons in or by a country listed in Country Group D:3 of Part 370 to Title 15 of the U.S. Code of Federal Regulations as it may be updated from time to time.

ARTICLE 10.

TERM AND TERMINATION

10.1 Term. The term of this Agreement (the “Term”) shall commence on the Execution Date, unless earlier terminated as provided in this Article 10 or in Section 12.12 (the date of any such termination, the “Termination Date”), shall continue in full force and effect, on a Product-by-Product basis, until such time as both Momenta and Mylan have ceased, for a continuous period of two (2) years, Developing and Commercializing such Product pursuant to this Agreement, themselves or through their respective Affiliates or Sublicensees, at which time this Agreement shall expire in its entirety with respect to such Product.

10.2 Termination for Convenience. Either Party has the right to terminate this Agreement in whole or on a Product-by-Product or country-by-country basis at will at any time during the time periods described below by providing written notice to the other Party.

(a) [***].

(b) Termination following IND Acceptance. If a Party elects to terminate the Agreement with respect to a Product prior to [***] after IND Acceptance of such Product (other than in connection with termination pursuant to Section [***], the terminating Party shall provide [***] prior written notice to the other Party.

(c) Termination Prior to Additional Clinical Trial or FDA Determination that Additional Clinical Trial is Not Required. If a Party elects to terminate the Agreement with respect to a Product more than [***] following IND Acceptance of such Product but before there is the first dosing in humans in an Additional Clinical Trial for such Product or an FDA determination that an Additional Clinical Trial is not required, such Party shall provide [***] prior written notice to the other Party.

(d) Termination After Additional Clinical Trial Initiation. If a Party elects to terminate the Agreement with respect to a Product at any time following the first dosing in humans in an Additional Clinical Trial for such Product, such Party shall provide [***] prior written notice to the other Party.

(e) Partial Termination. If a Party elects to terminate the Agreement with respect to one or more Products under this Section 10.2, the Parties’ rights and obligations with respect to such Product will be as set forth in Section 10.6.

10.3 Termination for Competitive Product.

(a) Competing Product Termination. Either Party may terminate this Agreement with respect to a Product on a country-by-country basis on [***] prior written notice to the other Party, if the non-terminating Party or its Affiliates are in breach of Section 6.5 with respect to such country and do not cure such breach within such [***] period.

(b) Patent Challenge. Each Party may terminate this Agreement (solely on a Product-by-Product basis) on [***] notice, with the termination being effective on the delivery of a second notice by the terminating Party to the non-terminating Party, if the non-terminating Party or its Affiliates or Sublicensees (directly or indirectly, individually or in association with any other Person) challenges the validity, enforceability or scope of any Patent Rights of the terminating Party (i.e., Momenta Patent Rights or Mylan Patent Rights, as applicable) or any of the Collaboration Patent Rights that, in either case, Cover a Product solely for the purpose of performing Legal Clearance Activities for such Product, and does not withdraw such challenge within the [***] notice period, or in the event that a Sublicensee is challenging, terminate the Sublicense to such Sublicensee with respect to such Product. Notwithstanding anything to the contrary in this Agreement, neither Party may use (and each Party shall ensure that none of its Affiliates or Sublicensees use) any of the other Party’s Confidential Information acquired in the course of the Collaboration in any proceeding that challenges the validity, enforceability or scope of any of the other Party’s Patent Rights or any Collaboration Patent Rights.

10.4 Termination of Agreement for Breach of Material Obligation. Each Party shall have the rights to terminate the Agreement in whole or on a Product-by-Product basis, as well on a country-by-country basis, for breach of material obligations hereunder by the other Party, as follows:

(a) Subject to Section 10.4(c), if a Party has breached any of its material obligations under this Agreement, the other Party shall have the right, but not the obligation, to terminate this Agreement if such breach continues for a period of [***] after written notice of such breach and the intent to terminate is provided to the breaching Party by the terminating Party. Notwithstanding the foregoing, if a Party disputes a breach alleged pursuant to this Section 10.4(a), the period to cure such breach shall be tolled until such dispute is resolved in accordance with Section 12.11.

(b) If an alleged breach pertains to a failure to exercise Commercially Reasonable Efforts, the [***] notice period in paragraph (a) above shall be extended to allow the Parties to undertake the following additional resolution process:

[***].

(c) If: (i) the U.S. is a Breached Country with respect to a Product; or (ii) there are two (2) or more Breached Countries with respect to the applicable Product, then Momenta shall have the right to terminate this Agreement, solely with respect to such Product, in the entire Territory pursuant to Section 10.4(b). A “Breached Country” means any Major Country in which Mylan fails to meet any of its material Commercialization diligence obligations described in Section 2.4(a) or in the first sentence of Article 2. Other than as set forth above in this paragraph (c), in the event that Momenta provides notice pursuant to

paragraph (a) or paragraph (b) above and the breach that is the subject of such notice is specific to one (1) or more Products or one (1) or more countries in the Territory, Momenta shall have the right to terminate in accordance with paragraph (a) solely with respect to such Product(s) or country(ies) with respect to which such breach occurred, and not in its entirety.

10.5 Termination for Bankruptcy. To the extent permitted under Applicable Law, either Party may terminate this Agreement immediately upon written notice to the other Party, if, at any time: (a) the other Party files in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of the Party or of substantially all of its assets; (b) the other Party is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed within [***] after the filing thereof; (c) the other Party shall propose or be a party to any dissolution or liquidation; or (d) the other Party shall make an assignment of substantially all of its assets for the benefit of creditors. The Parties shall retain and may fully exercise all of their respective rights and elections under the Bankruptcy Code.

10.6 Consequences of Termination.

(a) Without limiting any other legal or equitable remedies that either Party may have, if, after the Effective Date, this Agreement or a Product under the Agreement is terminated by Mylan under Section 10.2, is terminated by Momenta under Section 10.3, is terminated by Momenta for Mylan’s material breach under Section 10.4, is terminated by Momenta for Mylan’s bankruptcy or insolvency under Section 10.5, the following provisions will take effect as of the effective date of such termination with respect to those Products and countries for which the Agreement has terminated:

(i) Mylan will, [***] if requested by Momenta in writing, promptly transfer to Momenta or its designee: [***];

(ii) Mylan will, as requested by Momenta in writing: [***] to allow for an orderly transition of the Regulatory Submission or Regulatory Approval being transferred to Momenta. Momenta agrees to use Commercially Reasonable Efforts to limit this obligation to the extent practicable under the circumstances;

(iii) If, at the time of termination, Mylan is then-currently performing process development or Manufacturing Activities for the terminated Products, Mylan shall upon Momenta’s written request for a reasonable period of time (not to exceed [***] following receipt of written termination notice) and subject to Momenta’s agreement to reimburse Mylan for [***] associated therewith: (A) continue to perform such process development activities or Manufacturing Activities for the terminated Product(s); and (B) [***] to effect a transfer of such activities to Momenta or a Third Party on or before expiration of such [***] transition period. If Momenta so requests, Mylan will assign to Momenta any agreements with Third Parties reasonably necessary for and primarily relating to the Development, Manufacture or Commercialization of the terminated Product(s) to which Mylan is a party to the extent permitted by the terms of such agreements; provided, however, that Mylan shall not be obligated to pay any amounts to the counterparty or to any Third Party in connection with such assignment;

(iv) The licenses granted to Mylan and Momenta pursuant to Article 6 will terminate (except to the extent necessary to enable Mylan to perform its obligations under this Section 10.6 with respect to the terminated Products), and Mylan shall (and hereby does) grant Momenta [***], in each case to make, have made, use, import, offer for sale, sell and have sold the terminated Products in the Field in the terminated countries, subject to the following payment obligations with respect to a given Product. Mylan shall not use, or authorize any other Person to use, the [***] generated pursuant to this Agreement and existing as of the date of termination to Develop, Manufacture or Commercialize the terminated Products in the terminated countries.

(1) If the Agreement is terminated prior to or in connection with [***] for the applicable Product, Momenta shall pay to Mylan a royalty of [***] of Net Sales of such Product.

(2) If the Agreement is terminated after [***], but prior to [***], Momenta shall pay to Mylan a royalty of [***] of Net Sales of such Product.

(3) If the Agreement is terminated after [***], but prior to [***] of such Product, Momenta shall pay to Mylan a royalty of [***] of Net Sales of such Product.

(4) If the Agreement is terminated after [***] of such Product, but prior to [***] such Product, Momenta shall pay to Mylan a royalty of [***] of Net Sales of such Product.

(5) If the Agreement is terminated after [***] such Product, Momenta shall pay to Mylan a royalty of [***] of Net Sales of such Product.

The royalties due under Section 10.6(a)(iv)(1) — (5) shall be determined on a country-by-country and Product-by-Product basis beginning from the First Commercial Sale of such Product in such country until [***].

(v) Mylan will, upon Momenta’s written request, assign to Momenta all right, title and interest in the trademark(s) specific to the terminated Products in the terminated country(ies) and all goodwill associated therewith; provided that such assignment shall not include any Mylan corporate trademark or logo, or any derivative mark or variation thereof;

(vi) Mylan will, as requested by Momenta in writing and at Momenta’s sole cost and expense, reasonably cooperate with Momenta, (1) either to transition all Clinical Development activities initiated prior to the Termination Date with respect to the terminated Products or to wind-down and end such Clinical Development activities; or (2) transition the Manufacturing process for the terminated Products to Momenta or its designee;

(vii) A Party owing an amount pursuant to Section 10.6(c) shall submit payment to the other Party pursuant to Section 10.6(c), if applicable;

(viii) Mylan will, at Momenta’s request and [***] pursuant to a separate agreement to be negotiated by the Parties at the time of termination, transfer to Momenta all

inventory of terminated Product in its possession as of the date of termination intended for Commercialization in the terminated country(ies).

In addition, Momenta shall reimburse Mylan for [***] associated with the performance of the activities under subsections (i), (ii), (iii) and (vi), above; and

(ix) Mylan shall ensure that its Affiliates and permitted Sublicensees shall perform the obligations of Mylan under subsections (i) — (viii) where the power to perform such obligation is possessed or controlled by Mylan’s Affiliates and permitted Sublicensees and not otherwise by Mylan.

(b) Without limiting any other legal or equitable remedies that either Party may have, if, after the Effective Date, this Agreement or a Product under the Agreement is terminated by Momenta under Section 10.2, is terminated by Mylan under Section 10.3, is terminated by Mylan as a result of a material breach by Momenta under Section 10.4, is terminated by Mylan for Momenta’s bankruptcy or insolvency under Section 10.5, the following provisions will take effect as of the effective date of such termination with respect to those Products and those countries for which the Agreement has terminated:

(i) Momenta will, [***], promptly transfer to Mylan or its designee: [***];

(ii) Momenta will, as requested by Mylan in writing: [***] to allow for an orderly transition of the Regulatory Submission or Regulatory Approval being transferred to Mylan. Mylan agrees to use Commercially Reasonable Efforts to limit this obligation to the extent practicable under the circumstances;

(iii) If, at the time of termination, Momenta is then-currently performing process development or Manufacturing Activities for the terminated Products, Momenta shall upon Mylan’s written request for a reasonable period of time (not to exceed [***] following receipt of written termination notice) and subject to Mylan’s agreement to reimburse Momenta for [***] associated therewith: (A) continue to perform such process development activities or Manufacturing Activities for the terminated Product(s); and (B) [***] to effect a transfer of such activities to Mylan or a Third Party on or before expiration of such [***] transition period. If Mylan so requests, Momenta will assign to Mylan any agreements with Third Parties reasonably necessary for and primarily relating to the Development, Manufacture or Commercialization of the terminated Product(s) to which Momenta is a party to the extent permitted by the terms of such agreements; provided, however, that Momenta shall not be obligated to pay any amounts to the counterparty or to any Third Party in connection with such assignment;

(iv) Momenta will, as requested by Mylan in writing and [***], reasonably cooperate with Mylan, (1) either to transition all Clinical Development activities initiated prior to the Termination Date with respect to the terminated Products or to wind-down and end such Clinical Development activities or (2) transition the Manufacturing process for the terminated Products to Mylan or its designee;

(v) A Party owing an amount pursuant to Section 10.6(c) shall submit payment to the other Party pursuant to Section 10.6(c), if applicable; and

(vi) The licenses granted to Mylan and Momenta pursuant to Article 6 will terminate (except to the extent necessary to enable Mylan to perform its obligations under this Section 10.6 with respect to the terminated Products), and Momenta shall (and hereby does) grant Mylan [***], in each case to make, have made, use, import, offer for sale, sell and have sold the terminated Products in the Field in the terminated countries, subject to the following payment obligations with respect to a given Product. Momenta shall not use, or authorize any other Person to use, the [***] generated pursuant to this Agreement and existing as of the date of termination to Develop, Manufacture or Commercialize the terminated Products in the terminated countries.

(1) If the Agreement is terminated prior to or in connection with [***] for the applicable Product, Mylan shall pay to Momenta a royalty of [***] of Net Sales of such Product.

(2) If the Agreement is terminated after [***], but prior to [***], Mylan shall pay to Momenta a royalty of [***] of Net Sales of such Product.

(3) If the Agreement is terminated after [***], but prior to [***] of such Product, Mylan shall pay to Momenta a royalty of [***] of Net Sales of such Product.

(4) If the Agreement is terminated after [***] of such Product, but prior to [***] of such Product, Mylan shall pay to Momenta a royalty of [***] of Net Sales of such Product.

(5) If the Agreement is terminated after [***] of such Product, Mylan shall pay to Momenta a royalty of [***] of Net Sales of such Product.

The royalties due under Section 10.6(b)(vi)(1) — (5) shall be determined on a country-by-country and Product-by-Product basis beginning from the First Commercial Sale of such Product in such country until [***].

(vii) Momenta will, upon Mylan’s written request, assign to Mylan all right, title and interest in the trademark(s) specific to the terminated Products in the terminated country(ies) and all goodwill associated therewith; provided that such assignment shall not include any Momenta corporate trademark or logo, or any derivative mark or variation thereof;

(viii) Momenta will, at Mylan’s request and [***] pursuant to a separate agreement to be negotiated by the Parties at the time of termination, transfer to Mylan all inventory of terminated Product in its possession as of the date of termination intended for Commercialization in the terminated country(ies).

In addition, Mylan shall reimburse Momenta for [***] associated with the performance of the activities under subsections (i), (ii), (iii) and (iv), above.

(ix) Momenta shall ensure that its Affiliates and permitted Sublicensees shall perform the obligations of Momenta under subsections (i) — (viii) where the power to perform such obligation is possessed or controlled by Momenta’s Affiliates and permitted Sublicensees and not otherwise by Momenta.

(x) If either Party becomes aware of any known or suspected infringement or unauthorized use of any of the Momenta Intellectual Property or the Collaboration Intellectual Property, then such Party shall notify the other Party promptly and shall provide the other Party with all available evidence supporting such known or suspected infringement or unauthorized use, and following such notification, the Parties shall confer. [***], but will not be obligated, to bring an infringement action against such Third Party at its own expense and by counsel of its own choice, and [***] will have the right to participate in such action, at its own expense and by counsel of its own choice. If [***] fails to bring such an action prior to the earlier of: (A) [***] following [***] receipt of notice of the alleged infringement or misappropriation; or (B) [***] before the time limit, if any, set forth in the Applicable Law for the filing of such action, then [***] will have the right to bring and control any such action, at its own expense and by counsel of its own choice, and [***] will have the right to be represented in any such action, at its own expense and by counsel of its own choice. If a Party brings an infringement action pursuant to this Section 10.6(b)(x), the other Party shall reasonably assist the enforcing Party (at [***]) in such action if so requested, and such other Party will join as a named party to such action if necessary under Applicable Law for the enforcing Party to bring such action. Neither Party will have the right to settle any patent infringement litigation under this Section 10.6(b)(x) in a manner that diminishes the rights or interests of the other Party without the prior written consent of such other Party, [***]. Except as otherwise agreed in writing by the Parties, any recovery realized as a result of such litigation, after pro rata reimbursement of any litigation expenses of Mylan and Momenta, [***].

(c) Upon the termination of this Agreement in its entirety (including termination of the Agreement with respect to all Products) for any reason, the Parties shall promptly true-up any Development Expenses incurred by either Party pursuant to the reconciliation described in Section 4.2(a)(i) and thereafter Momenta shall promptly reimburse Mylan any remaining CPM Balance after such reconciliation.

10.7 Non-Exclusive Remedy. Termination of this Agreement shall be in addition to, and shall not prejudice, the Parties’ remedies at law or in equity, including, without limitation, the Parties’ ability to receive legal damages or equitable relief with respect to any breach of this Agreement, regardless of whether or not such breach was the reason for the termination.

10.8 Survival of Liability. Expiration or termination of this Agreement for any reason shall not release either Party from any liability that, at the time of such expiration or termination, has already accrued or that is attributable to a period prior to such expiration or termination, nor preclude either Party from pursuing any right or remedy it may have hereunder or at law or in equity with respect to any breach of this Agreement.

10.9 Survival of Articles and Sections. Upon termination of the Agreement as allowed for in this Article 10, the following Articles and Sections of this Agreement shall survive: Article 1; Article 6 (solely to the extent expressly provided for in Section 10.6); Article 7; Article 8; Article 9 (solely with respect to Products being Developed, Manufactured or

Commercialized pursuant to any surviving licenses under this Agreement); and Article 12 (excluding Section 12.8, Section 12.12, and Section 12.3(c), provided that if [***] shall survive); Section 2.6(a)(4); Section 4.1 (to the extent payments are earned prior to termination but have not been paid prior to termination of the applicable Product, [***]); Section 4.3; Section 4.4; Section 4.5; Section 5.1; Section 5.2; the last sentence of Section 5.3(a)(i); the last sentence of Section 5.3(a)(ii); Section 5.4 (with respect to Enforcement Litigation initiated prior to termination); Section 5.5 (with respect to Other Collaboration Litigation initiated prior to termination); Section 5.6 (with respect to Enforcement Litigation and Other Collaboration Litigation initiated prior to termination); Section 5.7 (with respect to [***]); Section 5.11(b) and (c) (with respect to any inventory of Product, packaging or labeling that includes a [***] existing as of the date of termination); Section 6.4; Section 6.5 [***] (solely to the extent termination is pursuant to Section 6.5 [***]); Section 6.6; Section 6.7; Section 10.6; Section 10.7; Section 10.8; Section 10.9; and Section 11.8(g).

ARTICLE 11.
REPRESENTATIONS, WARRANTIES AND COVENANTS

11.1 Momenta. Momenta represents and warrants to Mylan that, as of the Execution Date and the Effective Date: (a) it has the full right, power and authority to enter into this Agreement and to grant the rights and licenses granted by it hereunder; (b) to the knowledge of Momenta, there are no existing or threatened actions, suits or claims pending with respect to the subject matter hereof or the right of Momenta to enter into and perform its obligations under this Agreement; (c) it has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; (d) this Agreement has been duly executed and delivered on behalf of it, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof; (e) the execution and delivery of this Agreement do not conflict with or violate any requirement of Applicable Law or regulations and do not conflict with, or constitute a default under, any contractual obligation of Momenta; and (f) it is not researching, developing or commercializing any Competing Products (directly by Momenta or indirectly by any of its Affiliates or Third Party collaborators, licensees or sublicensees).

11.2 Mylan. Mylan represents and warrants to Momenta that as of the Execution Date and the Effective Date: (a) it has the full right, power and authority to enter into this Agreement and to grant the licenses granted by it hereunder; (b) to the knowledge of Mylan, there are no existing or threatened actions, suits or claims pending with respect to the subject matter hereof or the right of Mylan to enter into and perform its obligations under this Agreement; (c) it has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; (d) this Agreement has been duly executed and delivered on behalf of it, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof; (e) the execution and delivery of this Agreement do not conflict with or violate any requirement of Applicable Law or regulations and do not conflict with, or constitute a default under, any contractual obligation of Mylan; and (f) it is not researching, developing or commercializing any Competing Products (directly by Mylan or indirectly by any of its Affiliates or Third Party collaborators, licensees or sublicensees).

11.3 No Debarment. Each Party represents and warrants to the other Party that such Party, and such Party’s employees, officers, independent contractors, consultants, or agents who

will render services relating to the Products: (a) have not been debarred and are not subject to debarment or convicted of a crime for which an entity or person could be debarred under 21 U.S.C. Section 335a (or its equivalent under Applicable Law); and (b) have never been under indictment for a crime for which a person or entity could be debarred under said Section 335a (or its equivalent under Applicable Law). If during the Term, a Party has reason to believe that it or any of its employees, officers, independent contractors, consultants, or agents rendering services relating to the Products: (x) is or will be debarred or convicted of a crime under 21 U.S.C. Section 335a (or its equivalent under Applicable Law); or (y) is or will be under indictment under said Section 335a (or its equivalent under Applicable Law), then such Party shall immediately so notify the other Party in writing.

11.4 Additional Momenta Representations and Warranties. Momenta, on behalf of itself and all of its Affiliates, further represents and warrants to Mylan as of the Execution Date and the Effective Date that:

(a) based on Momenta’s knowledge [***];

(b) it is the [***];

(d) any and all [***];

(e) there are [***];

(f) [***];

(g) [***];

(h) there are [***]. In particular, [***];

(i) (i) [***], and (ii) all [***];

(j) all [***];

(k) Momenta has [***];

(l) Momenta is [***]; and

(m) (i) the [***]; and (ii) there have been [***].

11.5 Additional Mylan Representations and Warranties. Mylan, on behalf of itself and all of its Affiliates, further represents and warrants to Momenta as of the Execution Date and the Effective Date that:

(a) based on Mylan’s knowledge [***];

(b) it is [***];

(d) any and all [***];

(e) there are [***];

(f) there is [***];

(g) there are [***];

(h) there are [***]. In particular, to its knowledge, [***];

(i) (i) [***], and (ii) [***];

(j) [***];

(k) Mylan has [***];

(l) Mylan is [***]; and

(m) there has been [***].

11.6 Compliance with Applicable Law. Each Party shall carry out all work assigned to such Party in the applicable Product Work Plan(s) and its other obligations under this Agreement in material compliance with all Applicable Law, including: (a) the Food, Drug, and Cosmetic Act and any applicable implementing regulations, and relevant foreign equivalents thereof; (b) GMPs; (c) all other applicable FDA guidelines and relevant guidelines of applicable regulatory authorities; (d) all other applicable laws and regulations, including all applicable federal, national, multinational, state, provincial and local environmental, health and safety laws and regulations in effect at the time and place of Manufacture of a Product; (e) all applicable export and import control laws and regulations; and (f) all applicable anti-bribery and anti-corruption laws and regulations.

11.7 Anti-Corruption Laws.

(a) Each Party understands that the other Party is required to and does abide by the United States Foreign Corrupt Practices Act (“FCPA”), the United Kingdom Bribery Act (“UKBA”) and any other applicable anti-corruption laws (collectively, the “Anti-Corruption Laws”). Each Party represents and warrants that no one acting on its behalf will give, offer, agree or promise to give, or authorize the giving directly or indirectly, of any money or other thing of value to anyone as an inducement or reward for favorable action or forbearance from action or the exercise of influence (a) to any governmental official or employee (including employees of government-owned and government-controlled corporations or agencies), (b) to any political party, official of a political party, or candidate, (c) to an intermediary for payment to any of the foregoing, or (d) to any other Person or entity in a corrupt or improper effort to obtain or retain business or any commercial advantage, such as receiving a permit or license.

(b) Each Party understands that the other Party may immediately suspend payment, [***], if the actions or inactions of the first Party become subject to an investigation of potential violations of the FCPA. Moreover, each Party understands that if it fails to comply

with the provisions of any Applicable Law, including the FCPA, the other Party may terminate this Agreement, and any payments due thereunder, pursuant to Section 10.4.

(c) Each Party warrants that all Persons acting on its behalf will comply with all Applicable Laws in connection with all work performed hereunder, including the Anti-Corruption Laws if any, prevailing in the country(ies) in which each Party has its principal places of business or performs such work.

(d) Each Party further warrants and represents that should it learn or have reason to suspect any breach of the covenants in this Section 11.7, it will immediately notify the other Party.

(e) Each Party may appoint a certified public accounting firm to perform a financial audit to determine whether the other Party is in compliance with the terms of this Section 11.7. Each Party hereby agrees to grant the certified public accounting firm [***] access to its books, records, systems and accounts to the extent they pertain to transactions covered by this Agreement and are necessary for such purpose.

11.8 Trade Control Laws.

(a) Each Party will fully comply with all applicable export control, economic sanctions laws and anti-boycott regulations of the United States of America and other governments, including the U.S. Export Administration Regulations (Title 15 of the U.S. Code of Federal Regulations Part 730 et seq.) and the economic sanctions rules and regulations implemented under statutory authority or President’s Executive Orders and administered by the U.S. Treasury Department’s Office of Foreign Assets Control (Title 31 of the U.S. Code of Federal Regulations Part 500 et seq.) (collectively, “Trade Control Laws”).

(b) Each Party acknowledges and confirms that Trade Control Laws apply to its activities, its employees and Affiliates under this Agreement.

(c) No Product will be directly or indirectly shipped by the other Party to any country subject to U.S. or U.N. economic sanctions without the necessary licenses, even for transfer to non-sanctioned countries, and only after the express written consent of Mylan, [***].

(d) Neither Party shall be required by the terms of this Agreement to be directly or indirectly involved in the provision of goods, services or technical data that may be prohibited by applicable Trade Control Laws if performed by such Party. It shall be [***] to refrain from being directly or indirectly involved in the provision of goods, services or technical data that may be prohibited by applicable Trade Control Laws.

(e) Each Party hereby represents and warrants that it is not included on any of the restricted party lists maintained by the U.S. Government, including the Specially Designated Nationals List administered by the U.S. Treasury Department’s Office of Foreign Assets Control; the Denied Persons List, Unverified List or Entity List maintained by the U.S. Commerce Department’s Bureau of Industry and Security; or the List of Statutorily Debarred Parties maintained by the U.S. State Department’s Directorate of Defense Trade Controls.

(f) Each Party shall commit to maintaining awareness of the importance of Trade Control Laws throughout its organization. Each Party shall take such actions as are necessary and reasonable to prevent Product from being exported or re-exported to any country, entity or individual subject to U.S. trade sanctions, unless prior approval of the other Party, and relevant permission or license from the U.S. government has been obtained.

(g) Each Party will keep accurate and consistent records of all transactions covered by the Trade Control Laws for a minimum of [***] from the date of export or re-export; the date of expiration of any applicable license; or, other approval or reliance on any application of license exception or exemption.

11.9 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, OR VALIDITY OF TECHNOLOGY OR PATENT CLAIMS, WHETHER ISSUED OR PENDING.

ARTICLE 12.
MISCELLANEOUS

12.1 Governing Law. This Agreement shall be governed by, interpreted and construed in accordance with the substantive laws of the State of New York, without regard to conflicts of law principles.

12.2 Amendment; Waiver. This Agreement may only be amended or waived in a document that expressly states the Article or Section that is being modified or waived and that is signed by the Parties. The failure of a Party to insist upon strict performance of any provision of this Agreement or to exercise any right arising out of this Agreement shall neither impair that provision or right nor constitute a waiver of that provision or right, in whole or in part, in that instance or in any other instance.

12.3 Assignments.

(a) Neither this Agreement nor any right or obligation hereunder may be assigned or delegated, in whole or part, by either Party without the prior written consent of the other, except pursuant to sublicensing arrangements expressly contemplated herein; provided, however, that either Party may, without the written consent of the other, assign this Agreement and its rights and delegate its obligations hereunder to an Affiliate or to a successor-in-interest in connection with the transfer or sale of all or substantially all of its business and assets [***] or in connection with its merger, consolidation, change in control or similar transaction. Any permitted assignee shall assume all applicable obligations of its assignor under this Agreement, and shall provide the other Party with written notice of such assignment. Any purported assignment in violation of this Section 12.3 shall be null and void.

(b) Notwithstanding anything to the contrary set forth herein, if a Party (the “Assigning Party”) assigns or transfers this Agreement to a Third Party in accordance with

Section 12.3(a) (any such Third Party, a “Transferee”), whether by merger, assignment, transfer of assets, or operation of law, then the intellectual property rights that were held or developed by such Transferee prior to such assignment or transfer, or developed by such Transferee after such assignment or transfer outside of conducting the Assigning Party’s activities under this Agreement and without use of or reference to the Momenta Intellectual Property or Mylan Intellectual Property, as applicable, or the Collaboration Intellectual Property, in each case existing prior to such assignment or transfer, shall not be deemed to be Patent Rights, Know-How, improvements or other intellectual property owned or Controlled by such Assigning Party, and shall also not be affected or otherwise encumbered in any manner by this Agreement, including without limitation, by being subject to any rights of or licenses under this Agreement.

(i) Momenta Change of Control. Notwithstanding anything to the contrary in Section 12.3(a), in the event that Momenta is subject to a Change of Control (whether or not this Agreement is assigned in connection with such Change of Control), Momenta shall, within [***] after the date that such Change of Control closes (the “Momenta COC Closing Date”), provide Mylan with notice of such Change of Control (“Momenta COC Notice”). In the event of a Change of Control of Momenta, then:

(1) Upon Mylan’s written election after receipt of such Momenta COC Notice (which election shall be made by providing notice thereof (“Mylan COC Election Notice”) no later than [***] after receipt of the Momenta COC Notice), and effective as of the Momenta COC Closing Date (or the Effective Date, if later) solely if Mylan provides such Mylan COC Election Notice, subject to Section 12.3(c)(i)(2):

(A) Mylan shall [***].

(B) Momenta shall [***].

(D) Mylan shall [***];

(E) Except as provided in (F) below, Momenta shall [***];

(F) Mylan shall [***];

(G) Mylan shall [***];

(H) Each Party shall [***].

(I) After the Momenta COC Closing Date, Mylan shall [***]; and

(J) Mylan shall [***].

(2) The Acquiring Entity may elect to terminate its rights on a Product-by-Product basis by providing written notice to Mylan within [***] after receipt of the Mylan COC Election Notice. Upon Mylan’s receipt of such notice of such election from the Acquiring Entity with respect to one or more Products, such terminated Products shall be deemed to have been terminated pursuant to Section 10.2 by Momenta in all countries, provided that the royalties owed by Mylan pursuant to Section 10.6(b)(vi) shall be replaced by the royalties set forth below which [***].

(A) If the Product is terminated prior to [***], Mylan shall pay to Momenta a royalty of [***] of Net Sales of such Product.

(B) If the Product is terminated after [***], but prior to [***] of such Product, Mylan shall pay to Momenta a royalty of [***] of Net Sales of such Product.

(C) If the Agreement is terminated after [***] of such Product, but prior to [***] of such Product in a Major Country, Mylan shall pay to Momenta a royalty of [***] of Net Sales of such Product.

(D) If the Agreement is terminated after [***] of such Product in a Major Country, Mylan shall pay to Momenta a royalty of [***] of Net Sales of such Product.

[***]

(iii) Change of Control Definition. For purposes of the foregoing, a “Change of Control” shall mean, with respect to a Party, the occurrence of any of the following events: (1) the sale, transfer, conveyance or other disposition of all or a majority of the assets of the Party and its Affiliates to a Third Party; or (2)(A) the acquisition of beneficial ownership, directly or indirectly, by any person or group (within the meaning of the Securities Exchange Act of 1934 and the rules of the U.S. Securities and Exchange Commission thereunder as in effect on the Effective Date), of common shares or other equity interest representing more than fifty percent (50%) of the aggregate ordinary voting power represented by the issued and outstanding common shares or other equity interests of such Party; or (B) a merger, reorganization or consolidation involving such Party in which the stockholders of the Party, immediately prior to the merger, reorganization or consolidation, would not, immediately after the merger, reorganization or consolidation, beneficially own, directly or indirectly, shares representing in the aggregate more than fifty percent (50%) of the combined ordinary voting power of the resulting ultimate parent company; provided that in the case of clause (2) above, a Change of Control shall not be deemed to have occurred if: (X) atleast [***] or (Y) at least fifty percent (50%) of seats on the board of directors of the resulting ultimate parent company are occupied by members of the board of directors of the ultimate parent company of such Party prior to such transaction. The “Acquiring Entity” means the acquiring or resulting entity in such transaction.

(iv) For clarity, except as set forth in this Section 12.3, the Parties’ rights and obligations under this Agreement shall remain in effect in the event of a Change of Control or an assignment of this Agreement.

12.4 Independent Contractors. The relationship of the Parties hereto is that of independent contractors. The Parties intend not to be treated as agents, partners or joint venturers of each other for any purpose as a result of this Agreement or the transactions contemplated thereby.

12.5 Notices. Any notice required or permitted to be given under or in connection with this Agreement shall be deemed to have been sufficiently given if in writing and sent by certified or registered mail, return receipt requested, postage prepaid, or sent by a globally recognized overnight courier service, or sent by hand delivery, to the representative for such Party at the address set forth below for such Party. If a Party changes its representative or address, written notice shall be given promptly to the other Party of the new representative or address. Notice shall be deemed given on the [***] after being sent in the case of delivery by mail, on the [***] after being sent in the case of delivery by overnight courier, and [***] in the case of delivery by hand. The addresses of the Parties and representatives are as follows:

If to Momenta:		Momenta Pharmaceuticals, Inc.
		675 West Kendall Street
		Cambridge, MA 02142
		Attn: President and CEO

With a copy to:		Momenta Pharmaceuticals, Inc.
		675 West Kendall Street
		Cambridge, MA 02142
		Attn: General Counsel

If to Mylan:		Mylan Ireland Limited
		6th Floor, South Bank House
		Barrow Street
		Dublin 4
		Ireland
		Attention: []*, Director

With a copy to:		Mylan Inc.
		1000 Mylan Boulevard
		Canonsburg, PA 15317
		Attention: Global General Counsel

12.6 Force Majeure. Neither Party shall be held liable or responsible to the other nor be deemed to have defaulted under or breached the Agreement for failure or delay in fulfilling or performing any term of the Agreement (excluding payment obligations) to the extent, and for so long as, such failure or delay is caused by or results from causes beyond the reasonable control of such Party including but not limited to fires, earthquakes, floods, embargoes, wars, acts of war (whether war is declared or not), terrorist acts, insurrections, riots, civil commotion, and other similar causes. Performance shall be excused only to the extent of and during the reasonable continuance of such disability. Any deadline or time for performance specified in a Product Work Plan that falls due during or subsequent to the occurrence of any of the disabilities referred

to herein shall be automatically extended for a period of time equal to the period of such disability. Each Party shall immediately notify the other if, by reason of any of the disabilities referred to herein, it cannot meet any deadline or time for performance specified in any Exhibit to this Agreement. The Parties shall meet to discuss and negotiate in good faith what modifications to this Agreement or whether termination of this Agreement (and commercially reasonable terms associated with any such termination) should result from this force majeure.

12.7 Complete Agreement. This Agreement, including the Exhibits hereto, constitute the entire agreement, both written and oral, between the Parties with respect to the subject matter hereof, and that all prior agreements respecting the subject matter hereof, whether written or oral, expressed or implied, shall be of no force or effect, including the Prior Confidentiality Agreement (subject to Section 7.7).

12.8 Quality Agreement. No later than [***] prior to Mylan, Momenta or a Third Party engaged by Mylan or Momenta engaging in GMP activities, the Parties shall enter into a quality agreement relating to any GMP Product to be manufactured under the Product Work Plan; provided that the foregoing obligation shall apply solely to the extent that one Party is supplying Product to the other Party for purposes of Development or Commercialization of such Product hereunder.

12.9 Severability. If any provisions of this Agreement are determined to be invalid or unenforceable by a court of competent jurisdiction, the remainder of the Agreement shall remain in full force and effect without such provision. In such event, the parties shall in good faith negotiate a substitute clause for any provision declared invalid or unenforceable, which shall most nearly approximate the intent of the Parties in entering this Agreement.

12.10 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed to be an original and both together shall be deemed to be one and the same agreement. Counterparts may be signed and delivered by facsimile, or electronically in PDF format, each of which will be binding when sent.

12.11 Dispute Resolution.

(a) Executive Resolution. The Parties recognize that bona fide disputes may arise which relate to the Parties’ rights and obligations under this Agreement (“Disputed Matter”). In attempting to resolve any such Disputed Matters, the Disputed Matter shall first be elevated through each Party’s respective senior management representatives (in the case of Mylan, to its president or chief executive officer, and, in the case of Momenta, to its chief executive officer) for resolution. If the Disputed Matter remains unresolved [***] after referral to such senior management representatives, the Disputed Matter shall be resolved by binding dispute resolution proceedings in accordance with the procedure set forth in Section 12.11(b), except that, if the Disputed Matter is within the scope of the JSC pursuant to Section 3.6(b), the Disputed Matter shall be resolved pursuant to Section 12.11(c).

(b) Court. Subject to Section 12.11(c) and Section 12.11(d), if the Parties do not resolve a Disputed Matter using the process described in Section 12.11(a), then such Disputed Matter shall be subject to the exclusive jurisdiction of the state and federal courts in New York City, New York, U.S. and each Party hereby submits to such jurisdiction.

(i) If the Parties’ respective senior management representatives are unable to resolve a Disputed Matter that is within the scope of the JSC decision-making authority pursuant to Section 3.6(b), then, within [***] after such senior management representatives are unable to resolve such Disputed Matter, an arbitration panel will be selected pursuant to Section 12.11(c)(ii). Such arbitration panel will have the sole responsibility of resolving such Disputed Matter from a proposal submitted by each Party under this Section 12.11(c), and no other disputed matters, claims or counterclaims will be permitted by the Parties in such arbitration. Within [***] after selection of such arbitration panel, each Party shall submit to the arbitration panel, and exchange with the other Party in accordance with a procedure to be established by the arbitration panel, its proposal for resolving such Disputed Matter. Within [***] after receiving each Party’s proposal, [***]. The JSC shall promptly implement the proposal that is selected by the arbitration panel pursuant to this Section 12.11(c).

(ii) A Party seeking further resolution of the Disputed Matter pursuant to paragraph (i) above shall submit the Disputed Matter to resolution by final and binding arbitration in accordance with the American Arbitration Association (“AAA”) in accordance with its Commercial Arbitration Rules and applying the substantive law specified in Section 12.1. For the purposes of this Section 12.11(c), these rules and supplementary procedures shall be called the “Rules”. Whenever a Party decides to institute arbitration proceedings, it shall give written notice to that effect to the other Party, and the place of arbitration will be in New York, New York. The arbitration will be conducted by a panel of three (3) arbitrators, who will be appointed as follows: each Party will appoint a single arbitrator, and the two (2) arbitrators will agree on a third (3rd) arbitrator who will act as the chair of the arbitral tribunal, within [***] after their appointment. If the two (2) arbitrators do not agree on the third (3rd) arbitrator within such [***], then the third (3rd) arbitrator will be appointed by AAA in accordance with the Rules. Each arbitrator must have business or legal experience in the biosimilar or pharmaceutical industry. Decisions of the arbitrators that conform to the terms of this Section 12.11(c) shall be final and binding on the Parties, and judgment on the award so rendered may be entered in any court of competent jurisdiction. The Parties shall [***]. Notwithstanding the foregoing, [***]. Except as may be required by Applicable Law, no Party (or its representative, witnesses or arbitrators) may disclose the existence, content or result of any arbitration under this Agreement without the prior written consent of both Parties, except that no such consent shall be required to enter and enforce the judgment in court.

(d) Patent Disputes. Notwithstanding anything in this Agreement to the contrary, as between the Parties, any and all issues regarding the validity and enforceability of any patent in a country within the Territory (“Patent Matters”) shall be determined in a court or other tribunal, as the case may be, of competent jurisdiction under the applicable patent laws of such country. If such Disputed Matter involves both Patent Matters and other matters, the arbitrators will have the right to stay the arbitration until determination of Patent Matters material to the resolution of the Disputed Matters is resolved.

(e) Equitable Relief. Notwithstanding anything in this Agreement to the contrary, nothing in this Agreement shall prevent either Party from seeking equitable relief from any court of competent jurisdiction to prevent immediate and irreparable injury, loss, or damage on a provisional basis, pending the decision of the arbitrators on the ultimate merits of any

Disputed Matter. Any such request shall not be deemed incompatible with the agreement to arbitrate or a waiver of the right to arbitrate.

12.12 HSR Act. The Parties shall use Commercially Reasonable Efforts to promptly obtain any clearance required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (15 U.S.C. § 18a) (the “HSR Act”) for the consummation of this Agreement and the transactions contemplated hereby. Each Party shall furnish to the other Party reasonably necessary information and reasonable assistance as the other Party may request in connection with its compliance with the HSR Act, and any inquiries or requests for additional information in connection therewith. The Party’s shall share equally all of the filing fees pursuant to the HSR Act in connection with this Agreement; however, each Party shall bear all of the other costs and expenses (including attorneys’ fees) related to any filing by such Party pursuant to the HSR Act in connection with this Agreement. From the Execution Date until the Effective Date (or earlier termination of this Agreement), Momenta covenants to conduct its business with respect to the Product only in, and shall not take any action except in, the ordinary course of business and in a manner consistent in nature, scope and magnitude with past practices. If the expiration or early termination of the applicable waiting period under the HSR Act (such date, the “HSR Clearance Date”) has not occurred within [***] after the Execution Date, either Party may terminate this Agreement by written notice to the other Party. Except for Article 7, none of the provisions of this Agreement (for clarity, including Section 10.6 and Section 10.9), shall remain in effect after such termination.

12.13 Third Party Beneficiaries. None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party, including without limitation any creditor of either Party hereto. No such Third Party shall obtain any right under any provision of this Agreement or shall by reasons of any such provision make any claim in respect of any debt, liability or obligation (or otherwise) against either Party hereto.

12.14 Captions; Certain Conventions; Construction. All captions herein are for convenience only and shall not be interpreted as having any substantive meaning. The Exhibits to this Agreement are incorporated herein by reference and shall be deemed a part of this Agreement. Unless otherwise expressly provided herein or the context of this Agreement otherwise requires: (a) words of any gender include each other gender; (b) words such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear; (c) words using the singular shall include the plural, and vice versa; (d) the words “include,” “includes” and “including” shall be deemed to be followed by the phrase “but not limited to”, “without limitation”, “inter alia” or words of similar import; (e) references to “Article,” “Section,” “subsection”, “clause”, or other subdivision, or Exhibit, without reference to a document are to the specified provision or Exhibit of this Agreement; (f) the word “or” shall have the inclusive meaning associated with “and/or”; (g) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement law, rule of regulation thereof; (h) neither Party or its Affiliates shall be deemed to be acting “on behalf of” the other Party hereunder; and (i) the headings contained in this Agreement are used only as a matter of convenience, and in no way define, limit, construe or describe the scope or intent of any section of this Agreement. If the terms of this Agreement conflict with the terms of any Exhibit, the terms of this Agreement shall prevail. References to either Party include the successors and permitted assigns of that Party. The Exhibits are incorporated by reference into

this Agreement. The Parties have each consulted counsel of their choice regarding this Agreement, and, accordingly, no provisions of this Agreement will be construed against either Party on the basis that the Party drafted this Agreement or any provision thereof. The official text of this Agreement and any Exhibit, any notice given or accounts or statements required by this Agreement, and any dispute proceeding related to or arising hereunder, will be in English. If any dispute concerning the construction or meaning of this Agreement arises, then reference will be made only to this Agreement as written in English and not to any translation into any other language.

[Signature Page to Collaboration Agreement]

IN WITNESS WHEREOF, the Parties hereto have set their hand as of the Execution Date.

		MOMENTA PHARMACEUTICALS, INC.

		By:	/s/ Craig A. Wheeler
		Name:	Craig A. Wheeler
		Title:	President & CEO


		MYLAN IRELAND LIMITED

		By:	/s/ Peter McCormick
		Name:	Peter McCormick
		Title:	Global Head Supply Chain & Operations Services

Exhibit 1.11

[***]

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions

Exhibit 2.1(a)

[***]

Exhibit 2.4(f)

[***]

Exhibit 3.2

[***]

Exhibit 4.2(a)(i)

[***]

Exhibit 7.2

Initial Press Releases

Mylan’s Initial Press Release:

Mylan Announces Worldwide Collaboration with Momenta to Jointly Develop and Commercialize Six Biosimilar Products

Partnership Builds on Successful Existing Collaboration with Biocon and Positions Mylan as a World Leader in Biosimilars

HERTFORDSHIRE, England, and PITTSBURGH — Jan. 8, 2016 — Mylan N.V. (NASDAQ, TASE: MYL) today announced that it has entered into an exclusive global collaboration agreement with Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) to develop, manufacture and commercialize six of Momenta’s current biosimilar candidates, including Momenta’s biosimilar candidate, ORENCIA® (abatacept).

Mylan CEO Heather Bresch commented, “Mylan’s long-stated strategy has been to strategically invest in the long-term drivers of our future growth, both through our strong internal focus on R&D and through external collaboration with industry-leading partners. Biosimilars have long been one of these areas of important future growth, both for our company and our industry, given the rapidly growing market for biologic products, the undeniable patient need for more affordable versions of these life-saving medicines, and the attractive competitive landscape for the companies that are able to successfully bring these complex products at scale to the global market. This collaboration with Momenta, which is highly complementary to our partnership with Biocon, will position us as a definitive world leader in biosimilars, with a broad portfolio of 15 biosimilar/insulin analog generic products in development and the scale required to maximize investment in this area. Looking forward, Mylan will continue to expand and diversify its portfolio into such complex products, further differentiating us from other leading generics companies and establishing us at the forefront of the biologics space, while also ensuring we maintain one of the broadest, highest quality portfolios in our industry.

“This exciting collaboration with Momenta is focused on the next wave of biosimilar products and represents an important next step for Mylan, leveraging Momenta’s unique technology capabilities and Mylan’s strong science, biosimilar-development experience, operational excellence and expansive global commercial footprint. Importantly, this collaboration builds upon Mylan’s existing successful biologics and insulins collaboration with Biocon, which is focused on more near-term biosimilar opportunities. Through these partnerships, as well as the strong internal capabilities we have cultivated, Mylan is further expanding what is already one of the industry’s most robust and diverse biosimilar portfolios and helping to ensure we can deliver enhanced access to these critical products to patients around the world,” continued Ms. Bresch.

Craig A. Wheeler, president and chief executive officer of Momenta Pharmaceuticals, said, “We are thrilled to welcome Mylan as our new collaboration partner for biosimilars. Our two companies have a common focus on building an industry-leading biosimilar portfolio that offers safe, effective and affordable products to the patients that need them. By combining Momenta’s proven capabilities in complex-product development and Mylan’s world-class global R&D, supply chain and commercial infrastructure, we are well positioned to become a strong competitor in this developing field. Our joint vision is to bring high quality, cost-effective

biosimilar products to markets worldwide, and we believe our success will deliver a strong return to our companies’ stakeholders.”

Under the agreement with Momenta, Mylan will make an up-front cash payment of $45 million and up to $200 million in contingent milestone-related payments to Momenta, with each company sharing equally in the costs and profits with respect to the products. The companies will be jointly responsible for product development, and Mylan will lead worldwide commercialization efforts. All other financial terms and product details remain confidential.

Mylan’s collaboration with Momenta builds upon Mylan’s existing biologics and insulin analog partnership with Biocon. The Biocon partnership includes six biosimilar programs (trastuzumab, pegfilgrastim, adalimumab, bevacizumab, etanercept and filgrastim) and three insulin analogs (glargine, lispro and aspart). Five of these biosimilar programs have successfully completed Phase I clinical trials, and four of the programs are in active Phase III testing. Mylan and Biocon plan on submitting three biosimilar applications and one insulin application in the U.S. and Europe in 2016. Mylan already has successfully launched its trastuzumab biosimilar product in India and other emerging markets.

Mylan President Rajiv Malik commented, “Mylan has been fully engaged in the development of biosimilars with our partner Biocon for the last six years. During that time, Mylan has cultivated strong experience and expertise in the development of biosimilar products, and is executing on our programs with the scientific and analytical rigor required to fulfill health-authority expectations. Based upon our proactive and informative interactions with global health authorities on our nine active programs, we are extremely optimistic about the strength of our current development programs with Biocon, and we look forward to deploying our expertise in our collaboration with Momenta.”

Momenta also is providing information regarding the collaboration on its website.

Forward Looking Statement for Mylan

This press release includes statements that constitute “forward-looking statements,” including with regard to statements that biosimilars has long been an area of important future growth, both for Mylan and its industry, given the rapidly growing market for biologic products, the undeniable patient need for more affordable versions of these medicines, and the attractive competitive landscape for the companies that are able to successfully bring these complex products at scale to the global market; that the collaboration with Momenta, which is highly complementary to Mylan’s partnership with Biocon, will position Mylan as a definitive world leader in biosimilars with a broad portfolio of 15 biosimilar/insulin analog generic products in development and the scale required to maximize investment in this area; that Mylan will continue to expand and diversify its portfolio into such complex products, further differentiating it from other leading generics companies and establishing us at the forefront of the biologics space, while also ensuring it maintains one of the broadest, highest quality portfolios in its industry; that the collaboration with Momenta is focused on the next wave of biosimilar products and represents an important next step for Mylan, leveraging Momenta’s unique technology capabilities and Mylan’s strong science, biosimilar development experience, operational excellence and expansive global commercial footprint; that through Mylan’s partnerships, as well as the strong internal capabilities it has cultivated, Mylan is further expanding what is already one of the industry’s most robust and diverse biosimilar portfolios and helping to ensure we can deliver enhanced access to these critical products to patients around the world; that Mylan and Momenta have a common focus on building an industry leading biosimilar portfolio that offers safe, effective and affordable products to the patients that need them; that Mylan and

Momenta’s joint vision is to bring high quality, cost effective biosimilar products to markets worldwide and they believe their success will deliver a strong return to their respective stakeholders; that Mylan and Biocon plan on submitting three biosimilar applications and one insulin application in the U.S. and Europe in 2016; that Mylan is executing on its programs with the scientific and analytical rigor required to fulfill health authority expectations; and that Mylan is extremely optimistic about the strength of its current development programs with Biocon and looks forward to deploying its expertise in our collaboration with Momenta. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any changes in or difficulties with Mylan’s or its partners’ ability to develop, manufacture, and commercialize biosimilar candidates; any regulatory, legal, or other impediments to Mylan’s or its partners’ ability to bring biosimilar candidates to market; Mylan’s and its partners’ ability to protect intellectual property and preserve intellectual property rights, including with respect to biosimilar candidates; the effect of any changes in Mylan’s or its partners’ customer and supplier relationships and customer purchasing patterns; other changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan or its partners; the scope, timing, and outcome of any ongoing legal proceedings and the impact of any such proceedings on Mylan’s or its partners’ business; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in the United States and abroad; risks associated with international operations; clearance under the Hart-Scott-Rodino Antitrust Improvements Act; other uncertainties and matters beyond the control of management; and the other risks detailed in Mylan’s filings with the Securities and Exchange Commission. Mylan undertakes no obligation to update these statements for revisions or changes after the date of this release.

Forward Looking Statement for Momenta Pharmaceuticals

Momenta’s Initial Press Release:

Momenta Pharmaceuticals Announces Worldwide Collaboration with Mylan to Jointly Develop and Commercialize Six Biosimilar Products

— Momenta to Host a Conference Call for Investors Today at 10 AM ET—

CAMBRIDGE, MA — January 8, 2016 —Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) today announced that it has entered into an exclusive global collaboration agreement with Mylan N.V. (Nasdaq, TASE: MYL) to develop, manufacture and commercialize six of Momenta’s current biosimilar candidates, including Momenta’s biosimilar candidate ORENCIA® (abatacept).

“We are thrilled to welcome Mylan as our new collaboration partner for biosimilars. Our two companies have a common focus on building an industry leading biosimilar portfolio that offers safe, effective and affordable products to the patients that need them,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “By combining Momenta’s proven capabilities in complex product development and Mylan’s world class global R&D, supply chain and commercial infrastructure, we are well positioned to become a strong competitor in this developing field. Our joint vision is to bring high quality, cost effective biosimilar products to markets worldwide and we believe our success will deliver a strong return to our companies’ stakeholders.”

Mylan CEO Heather Bresch commented, “This exciting collaboration with Momenta is focused on the next wave of biosimilar products and represents an important next step for Mylan in this area of significant future growth, leveraging Momenta’s unique technology capabilities and Mylan’s strong science, biosimilar development experience, operational excellence and expansive global commercial footprint. Through this collaboration, as well as other partnerships and the strong internal capabilities we have cultivated, Mylan is further expanding what is already one of the industry’s most robust and diverse biosimilar portfolios and helping to ensure we can deliver enhanced access to these critical products to patients around the world.”

Under the agreement, Mylan will make an upfront cash payment of $45 million and up to $200 million in contingent milestone payments to Momenta, with each company sharing equally in the costs and profits with respect to the products. The companies will be jointly responsible for product development and Mylan will lead worldwide commercialization efforts, with Momenta having an option to co-commercialize in a supporting commercial role, any approved products in the United States.

Conference Call Information

Momenta will host a conference call for investors today at 10 am ET to discuss this important biosimilars collaboration with Mylan. The conference call will be webcast live and a link to the webcast may be accessed on the “Investors” section of the company’s website, www.momentapharma.com. Please go to the site at least 15 minutes prior to the call to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.

To access the call you may also dial (877) 224-9084 (domestic) or (720) 545-0022 (international) prior to the scheduled conference call time and provide the access code 21610391. A replay of the call will be available approximately two hours after the conclusion of the call. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 21610391.

About Momenta

Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex drugs and is headquartered in Cambridge, MA. Momenta is applying its technology to the development of generic versions of complex drugs, biosimilar and potentially interchangeable biologics, and to the discovery and development of novel therapeutics for oncology and autoimmune indications.

To receive additional information about Momenta, please visit the website at www.momentapharma.com, which does not form a part of this press release.

Our logo, trademarks, and service marks are the property of Momenta Pharmaceuticals, Inc. All other trade names, trademarks, or service marks are property of their respective owners.

Forward Looking Statement For Momenta Pharmaceuticals

Statements in this press release regarding management’s future expectations, beliefs, intentions, goals, strategies, plans or prospects, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements concerning the collaboration agreement between Mylan N.V. and Momenta Pharmaceuticals, Inc., including anticipated payments, as well as future development, manufacture, and commercialization of biosimilars under the agreement; and our and Mylan’s ability to successfully develop and commercialize high quality, cost-effective biosimilar products, compete successfully in biosimilars, and increase shareholder value. Forward-looking statements may be identified by words such as “anticipate,” “believe,” “continue,” “could,” “hope,” “target,” “project,” “goal,” “objective,” “guidance,” “plan,” “potential,” “predict,” “might,” “estimate,” “expect,” “intend,” “may,” “seek”, “should,” “will,” “would,” “look forward” and other similar words or expressions, or the negative of these words or similar words or expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, including receiving clearance under the Hart-Scott-Rodino Antitrust Improvements Act and those referred to under the section “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 filed with the Securities and Exchange Commission, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, or the risks and factors noted below by Mylan N.V., the Company’s actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein. The Company is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Forward Looking Statement for Mylan N.V.

This press release includes statements that constitute “forward-looking statements,” including with regard to statements that the collaboration is focused on the next wave of biosimilar products and represents an important next step for Mylan in this area of significant future growth, leveraging Momenta’s unique technology capabilities and Mylan’s strong science, biosimilar development experience, operational excellence and expansive global commercial footprint and that Mylan is further expanding what is already one of the industry’s most robust and diverse biosimilar portfolios and helping to ensure it can deliver enhanced access to these critical products to patients around the world. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any changes in or difficulties with Mylan’s or its partners’ ability to develop, manufacture, and commercialize biosimilar candidates; any regulatory, legal, or other impediments to Mylan’s or its partners’ ability to bring biosimilar candidates to market; Mylan’s and its partners’ ability to protect intellectual property and preserve intellectual property rights, including with respect to biosimilar candidates; the effect of any changes in Mylan’s or its partners’ customer and supplier relationships and customer purchasing patterns; other changes in third-party relationships; the impact of competition; changes in the economic and financial conditions of the businesses of Mylan or its partners; the scope, timing, and outcome of any ongoing legal proceedings and the impact of any such proceedings on Mylan’s or its partners’ business; actions and decisions of healthcare and pharmaceutical regulators, and changes in healthcare and pharmaceutical laws and regulations, in the United States and abroad; risks associated with international operations; clearance under the Hart-Scott-Rodino Antitrust Improvements Act; other uncertainties and matters beyond the control of management; and the other risks detailed in Mylan’s filings with the Securities and Exchange Commission. Mylan undertakes no obligation to update these statements for revisions or changes after the date of this release.

###

MOMENTA INVESTOR CONTACT:	MOMENTA MEDIA CONTACT:
Sarah Carmody	Karen Sharma
Momenta Pharmaceuticals	MacDougall Biomedical Communications
1-617-395-5189	1-781-235-3060
IR@momentapharma.com	Momenta@macbiocom.com

Exhibit 11.4(a)

[***]

Exhibit 11.4(b)

[***]

Exhibit 11.4(c)

[***]

Exhibit 11.4(f)

[***]

Exhibit 11.4(g)

[***]

Exhibit 11.4(k)

[***]

Exhibit 11.5(a) — (l)

[***]

Exhibit 31.1

CERTIFICATION

I, Craig A. Wheeler certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Momenta 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 officer 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 officer 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 the 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.

Dated: May 6, 2016	/s/ Craig A. Wheeler
	Craig A. Wheeler
	President and Chief Executive Officer

Exhibit 31.2

CERTIFICATION

I, Richard P. Shea certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Momenta Pharmaceuticals, Inc.;

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.

Dated: May 6, 2016	/s/ Richard P. Shea
	Richard P. Shea
	Senior Vice President and Chief Financial Officer

Exhibit 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of Momenta Pharmaceuticals, Inc. (the “Company”) for the period ended March 31, 2016 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Craig A. Wheeler, President and Chief Executive Officer of the Company, and Richard P. Shea, Senior Vice President and Chief Financial Officer of the Company, each hereby certifies, pursuant to 18 U.S.C. Section 1350, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: May 6, 2016	/s/ Craig A. Wheeler
	Craig A. Wheeler
	President and Chief Executive Officer

Dated: May 6, 2016	/s/ Richard P. Shea
	Richard P. Shea
	Senior Vice President and Chief Financial Officer

mnta-20160331.xml
Attachment: XBRL INSTANCE DOCUMENT

mnta-20160331.xsd
Attachment: XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT

mnta-20160331_cal.xml
Attachment: XBRL TAXONOMY EXTENSION CALCULATION LINKBASE DOCUMENT

mnta-20160331_lab.xml
Attachment: XBRL TAXONOMY EXTENSION LABELS LINKBASE DOCUMENT

mnta-20160331_pre.xml
Attachment: XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT

mnta-20160331_def.xml
Attachment: XBRL TAXONOMY EXTENSION DEFINITION LINKBASE DOCUMENT

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2016	Apr. 12, 2016
Document and Entity Information
Entity Registrant Name	MOMENTA PHARMACEUTICALS INC
Entity Central Index Key	0001235010
Document Type	10-Q
Document Period End Date	Mar. 31, 2016
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Well-known Seasoned Issuer	Yes
Entity Filer Category	Large Accelerated Filer
Entity Common Stock, Shares Outstanding		69,496,190
Document Fiscal Year Focus	2016
Document Fiscal Period Focus	Q1

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015
Current assets:
Cash and cash equivalents	$ 89,431	$ 61,461
Marketable securities	256,359	288,583
Collaboration receivable	21,742	21,185
Prepaid expenses and other current assets	4,405	3,479
Total current assets	371,937	374,708
Marketable securities	17,038
Property and equipment, net	21,547	21,896
Restricted cash	20,660	20,660
Intangible assets, net	3,263	3,528
Other long-term assets	978	248
Total assets	435,423	421,040
Current liabilities:
Accounts payable	3,388	4,053
Accrued expenses	16,231	24,499
Deferred revenue	17,144	9,770
Other current liabilities	110	460
Total current liabilities	36,873	38,782
Deferred revenue, net of current portion	46,475	12,213
Other long-term liabilities	592	69
Total liabilities	$ 83,940	$ 51,064
Commitments and contingencies (Note 8)
Stockholders' Equity:
Preferred stock, $0.01 par value per share; 5,000 shares authorized, 100 shares of Series A Junior Participating Preferred Stock, $0.01 par value per share designated and no shares issued and outstanding
Common stock, $0.0001 par value per share; 100,000 shares authorized , 69,495 shares issued and 69,376 shares outstanding at March 31, 2016 and 69,077 shares issued and 68,958 outstanding at December 31, 2015	$ 7	$ 7
Additional paid-in capital	829,771	824,385
Accumulated other comprehensive income	137	4
Accumulated deficit	(476,384)	(452,372)
Treasury stock, at cost, 119 shares	(2,048)	(2,048)
Total stockholders' equity	351,483	369,976
Total liabilities and stockholders' equity	$ 435,423	$ 421,040

CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares shares in Thousands	Mar. 31, 2016	Dec. 31, 2015
Common stock, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common stock, shares authorized	100,000	100,000
Common stock, shares issued	69,495	69,077
Common stock, shares outstanding	69,376	68,958
Treasury stock, at cost	119	119
Preferred Stock
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01
Preferred stock, shares authorized	5,000	5,000
Series A Junior Participating Preferred Stock.
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01
Preferred stock, shares authorized	100	100

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Collaboration revenues:
Product revenue	$ 14,800	$ 2,722
Research and development revenue	5,050	5,840
Total collaboration revenue	19,850	8,562
Operating expenses:
Research and development	28,757	22,749
General and administrative	15,647	7,890
Total operating expenses	44,404	30,639
Operating loss	(24,554)	(22,077)
Other income:
Interest income	480	112
Other income	62	88
Total other income	542	200
Net loss	$ (24,012)	$ (21,877)
Basic and diluted net loss per share (in dollars per share)	$ (0.35)	$ (0.40)
Weighted average shares used in computing basic and diluted net loss per share (in shares)	68,285	54,492
Comprehensive loss:
Net loss	$ (24,012)	$ (21,877)
Net unrealized holding gains on available-for-sale marketable securities	133	18
Comprehensive loss	$ (23,879)	$ (21,859)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Parenthetical) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Non-cash share-based compensation expense	$ 4,828	$ (4,385)
Research and development expense
Non-cash share-based compensation expense	2,065	(2,215)
General and administrative expense
Non-cash share-based compensation expense	$ 2,763	$ (2,170)

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Cash Flows from Operating Activities:
Net loss	$ (24,012)	$ (21,877)
Non-cash items:
Depreciation and amortization	1,889	2,089
Share-based compensation expense (income)	4,828	(4,385)
Amortization of premium on investments	290	304
Amortization of intangibles	265	265
Changes in operating assets and liabilities:
Collaboration receivable	(557)	1,665
Prepaid expenses and other current assets	(926)	157
Other long-term assets	(730)
Accounts payable	(665)	(1,939)
Accrued expenses	(8,268)	(3,037)
Deferred revenue	41,636	(1,687)
Other current liabilities	(350)	20
Other long-term liabilities	523	(151)
Net cash provided by (used in) operating activities	13,923	(28,576)
Cash Flows from Investing Activities:
Purchases of property and equipment	(1,540)	(539)
Purchases of marketable securities	(119,368)	(15,694)
Proceeds from maturities of marketable securities	134,397	44,492
Net cash provided by investing activities	13,489	28,259
Cash Flows from Financing activities:
Net proceeds from issuance of common stock under ATM facilities		33,665
Proceeds from issuance of common stock under stock plans	558	2,911
Net cash provided by financing activities	558	36,576
Increase in cash and cash equivalents	27,970	36,259
Cash and cash equivalents, beginning of period	61,461	61,349
Cash and cash equivalents, end of period	$ 89,431	$ 97,608

The Company	3 Months Ended
The Company	Mar. 31, 2016
The Company
The Company	1. The Company Business Momenta Pharmaceuticals, Inc., or the Company or Momenta, was incorporated in the state of Delaware in May 2001 and began operations in early 2002. Its facilities are located in Cambridge, Massachusetts. Momenta is a biotechnology company focused on developing generic versions of complex drugs, biosimilars and novel therapeutics for oncology and autoimmune disease. The Company presently derives all of its revenue from its collaborations.

Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2016

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

Use of Estimates

Revenue Recognition

The Company evaluates multiple element agreements under the Financial Accounting Standards Board’s, or FASB, Accounting Standards Update, or ASU, No. 2009-13, Multiple-Deliverable Revenue Arrangements, or ASU 2009-13. When evaluating multiple element arrangements under ASU 2009-13, the Company identifies the deliverables included within the agreement and determines whether the deliverables under the arrangement represent separate units of accounting. Deliverables under the arrangement are a separate unit of accounting if (i) the delivered item has value to the customer on a standalone basis and (ii) if the arrangement includes a general right of return relative to the delivered item and delivery or performance of the undelivered items are considered probable and substantially within the Company’s control. This evaluation requires subjective determinations and requires management to make judgments about the individual deliverables and whether such deliverables are separable from the other aspects of the contractual relationship. In determining the units of accounting, management evaluates certain criteria, including whether the deliverables have standalone value, based on the consideration of the relevant facts and circumstances for each arrangement. The Company considers whether the collaborator can use the license or other deliverables for their intended purpose without the receipt of the remaining elements, and whether the value of the deliverable is dependent on the undelivered items and whether there are other vendors that can provide the undelivered items.

Up-Front License Fees

Milestones

The regulatory milestones under the collaboration with Baxalta are considered to be contingent fees that will be recorded if earned in future periods.

Sales-based and commercial milestones are accounted for as royalties and are recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met.

Profit Share and Royalties on Sandoz’ Sales of Enoxaparin Sodium Injection® and GLATOPA®

Research and Development Revenue under Collaborations with Sandoz and Baxalta

Collaboration Receivable

Collaboration receivable represents:

Amounts due to the Company for profit share on Sandoz’ sales of Enoxaparin Sodium Injection and GLATOPA;

Amounts due to the Company for reimbursement of research and development services and external costs under the collaborations with Sandoz and Baxalta; and

The net amount due from Mylan for its 50% share of collaboration expenses under the cost-sharing arrangement.

The Company has not recorded any allowance for uncollectible accounts or bad debt write-offs and it monitors its receivables to facilitate timely payment.

Deferred Revenue

Deferred revenue represents consideration received from collaborators in advance of achieving certain criteria that must be met for revenue to be recognized in conformity with GAAP.

Net Loss Per Common Share

The following table presents anti-dilutive shares for the three months ended March 31, 2016 and 2015 (in thousands):

	Three Months Ended March 31,
	2016	2015
Weighted-average anti-dilutive shares related to:
Outstanding stock options	6,659	6,519
Restricted stock awards	335	685

Fair Value Measurements

Description	Balance as of March 31, 2016		Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Other Unobservable Inputs (Level 3)
Assets:
Cash equivalents:
Money market funds and overnight repurchase agreements	$	86,685	$	62,685	$	24,000	$	—
Marketable securities:
U.S. government-sponsored enterprise securities	4,999		—		4,999		—
Corporate debt securities	74,479		—		74,479		—
Commercial paper obligations	111,578		—		111,578		—
Asset-backed securities	82,341		—		82,341		—


Total	$	360,082	$	62,685	$	297,397	$	—

Description	Balance as of December 31, 2015		Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Other Unobservable Inputs (Level 3)
Assets:
Cash equivalents:
Money market funds and overnight repurchase agreements	$	54,077	$	30,077	$	24,000	$	—
Marketable securities:
U.S. government-sponsored enterprise securities	24,290		—		24,290		—
Corporate debt securities	73,651		—		73,651		—
Commercial paper obligations	125,805		—		125,805		—
Asset-backed securities	64,837		—		64,837		—


Total	$	342,660	$	30,077	$	312,583	$	—

There have been no impairments of the Company’s assets measured and carried at fair value during the three months ended March 31, 2016 and 2015. In addition, there were no changes in valuation techniques or transfers between the fair value measurement levels during the three months ended March 31, 2016. The fair value of Level 2 instruments classified as marketable securities were determined through third party pricing services. For a description of the Company’s validation procedures related to prices provided by third party pricing services, refer to Note 2 “ Summary of Significant Accounting Policies: Fair Value Measurements “ to the Company’s consolidated financial statements in its Annual Report on Form 10-K for the year ended December 31, 2015. The carrying amounts reflected in the Company’s accompanying condensed consolidated balance sheets for cash, accounts receivable, unbilled receivables, other current assets, accounts payable and accrued expenses approximate fair value due to their short-term maturities.

Cash, Cash Equivalents and Marketable Securities

The Company’s cash equivalents are primarily composed of money market funds carried at fair value, which approximates cost at March 31, 2016 and December 31, 2015. The Company classifies corporate debt securities, commercial paper, asset-backed securities and U.S. government-sponsored enterprise securities as short-term and long-term marketable securities in its consolidated financial statements. See Note 2 “Summary of Significant Accounting Policies: Cash, Cash Equivalents and Marketable Securities” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 for a discussion of the Company’s accounting policies.

The following tables summarize the Company’s cash, cash equivalents and marketable securities as of March 31, 2016 and December 31, 2015 (in thousands):

As of March 31, 2016	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
Cash, money market funds and overnight repurchase agreements	$	89,431	$	—	$	—		$	89,431
U.S. government-sponsored enterprise securities due in one year or less	4,998		1		—			4,999
Corporate debt securities due in one year or less	74,473		8		(2		)	74,479
Commercial paper obligations due in one year or less	111,449		129		—			111,578
Asset-backed securities due in one year or less	65,302		15		(14		)	65,303
Asset-backed securities due in two years or less	17,038		4		(4		)	17,038


Total	$	362,691	$	157	$	(20	)	$	362,828


Reported as:
Cash and cash equivalents	$	89,431	$	—	$	—		$	89,431
Marketable securities	273,260		157		(20		)	273,397


Total	$	362,691	$	157	$	(20	)	$	362,828

As of December 31, 2015	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
Cash, money market funds and overnight repurchase agreements	$	61,461	$	—	$	—		$	61,461
U.S. government-sponsored enterprise securities due in one year or less	24,285		5		—			24,290
Corporate debt securities due in one year or less	73,735		1		(84		)	73,652
Commercial paper obligations due in one year or less	125,693		120		(8		)	125,805
Asset-backed securities due in one year or less	64,866		—		(30		)	64,836


Total	$	350,040	$	126	$	(122	)	$	350,044


Reported as:
Cash and cash equivalents	$	61,461	$	—	$	—		$	61,461
Marketable securities	288,579		126		(122		)	288,583


Total	$	350,040	$	126	$	(122	)	$	350,044

The following table summarizes the aggregate fair value of these securities as of March 31, 2016 and December 31, 2015 (in thousands):

	As of March 31, 2016					As of December 31, 2015
	Aggregate Fair Value		Unrealized Losses			Aggregate Fair Value		Unrealized Losses
Corporate debt securities due in one year or less	$	20,024	$	(2	)	$	70,657	$	(84	)
Commercial paper obligations due in one year or less	$	—	$	—		$	33,734	$	(8	)
Asset-backed securities due in one year or less	$	22,944	$	(14	)	$	61,337	$	(30	)
Asset-backed securities due in two years or less	$	8,015	$	(4	)	$	—	$	—

Treasury Stock

Comprehensive Income (Loss)

New Accounting Pronouncements

In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40). The ASU requires all entities to evaluate for the existence of conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the issuance date of its financial statements. The accounting standard is effective for interim and annual periods after December 15, 2016, and will not have a material impact on the consolidated financial statements, but may impact the Company’s footnote disclosures regarding liquidity.

Intangible Assets

3 Months Ended

Mar. 31, 2016

Intangible Assets

Intangible Assets

3. Intangible Assets

Intangible assets consist solely of core developed technology acquired as part of a 2007 asset purchase agreement with Parivid LLC. See Part I, Item 1 “Business—Collaborations, Licenses and Asset Purchases—Parivid” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 for relevant disclosures. The developed technology intangible assets are being amortized over the estimated useful life of the Enoxaparin Sodium Injection and GLATOPA developed technologies of approximately 10 years. As of March 31, 2016 and December 31, 2015, intangible assets, net of accumulated amortization, were as follows (in thousands):

	March 31, 2016							December 31, 2015
	Gross Carrying Amount		Accumulated Amortization			Net Carrying Value		Gross Carrying Amount		Accumulated Amortization			Net Carrying Value
Total intangible assets for core and developed technology and non-compete agreement	$	10,427	$	(7,164	)	$	3,263	$	10,427	$	(6,899	)	$	3,528

The Company expects to incur amortization expense of approximately $1.1 million per year for each of the next three years and $0.1 million in the fourth year.

Restricted Cash	3 Months Ended
Restricted Cash	Mar. 31, 2016
Restricted Cash
Restricted Cash	4. Restricted Cash The Company designated $17.5 million as collateral for a security bond posted in the litigation against Amphastar, International Medical Systems, Ltd., a wholly owned subsidiary of Amphastar Pharmaceuticals, Inc. and Actavis, Inc. (formerly Watson Pharmaceuticals, Inc.), or Actavis, as discussed within Note 8, “Commitments and Contingencies”. Amphastar, International Medical Systems, Ltd. and Amphastar Pharmaceuticals, Inc. are collectively referred to as Amphastar. The $17.5 million is held in an escrow account by Hanover Insurance. The Company classified this restricted cash as long-term as the timing of a final decision in the Enoxaparin Sodium Injection patent litigation is not known. The Company designated $2.4 million as collateral for a letter of credit related to the lease of office and laboratory space located at 675 West Kendall Street in Cambridge, Massachusetts. This balance will remain restricted through April 2018 and therefore is classified as non-current in the Company’s consolidated balance sheet. The Company will earn interest on the balance. The Company designated $0.7 million as collateral for a letter of credit related to the lease of office and laboratory space located at 320 Bent Street in Cambridge, Massachusetts. This balance will remain restricted through the lease term and during any lease term extensions. The Company will earn interest on the balance.

Collaboration and License Agreements

3 Months Ended

Mar. 31, 2016

Collaborations and License Agreements

Collaborations and License Agreements

5. Collaboration and License Agreements

At March 31, 2016, the Company had collaboration and license agreements with Sandoz, Sandoz AG, Baxalta and Mylan.

The Company records product revenue based on Sandoz’ sales of Enoxaparin Sodium Injection and GLATOPA.

The following tables provide amounts by year and by line item included in the Company’s accompanying condensed consolidated statements of operations and comprehensive loss attributable to transactions arising from its significant collaborative arrangements and all other arrangements, as defined in the Financial Accounting Standards Board’s Accounting Standards Codification Topic 808, Collaborative Arrangements. The dollar amounts in the tables below are in thousands.

	For the Three Months Ended March 31, 2016
	2003 Sandoz Collaboration Agreement		2006 Sandoz Collaboration Agreement		Baxalta Collaboration Agreement		Mylan Collaboration Agreement (1)		Total Collaborations
Collaboration revenues:
Product revenue	$	—	$	14,800	$	—	$	—	$	14,800

Research and development revenue:
Recognition of upfront payments and license payments	—		—		2,442		922		3,364
Research and development services and external costs under Sandoz and Baxalta collaborations	77		645		964		—		1,686

Total research and development revenue	$	77	$	645	$	3,406	$	922	$	5,050

Total collaboration revenues	$	77	$	15,445	$	3,406	$	922	$	19,850

Operating expenses:
Research and development expense(2)(3)	$	—	$	293	$	314	$	3,680	$	4,287
General and administrative expense(2)(3)	$	1,064	$	95	$	282	$	112	$	1,553

Total operating expenses	$	1,064	$	388	$	596	$	3,792	$	5,840

	For the Three Months Ended March 31, 2015
	2003 Sandoz Collaboration Agreement		2006 Sandoz Collaboration Agreement		Baxalta Collaboration Agreement		Total Collaborations
Collaboration revenues:
Product revenue	$	2,722	$	—	$	—	$	2,722

Research and development revenue:
Milestone payments	—		—		—		—
Recognition of upfront payments and license payments	—		—		1,686		1,686
Research and development services and external costs	251		684		3,219		4,154

Total research and development revenue	$	251	$	684	$	4,905	$	5,840

Total collaboration revenues	$	2,973	$	684	$	4,905	$	8,562

Operating expenses:
Research and development expense(2)	$	31	$	148	$	608	$	787
General and administrative expense(2)	$	110	$	77	$	406	$	593

Total operating expenses	$	141	$	225	$	1,014	$	1,380

(1)

The Mylan Collaboration Agreement, as defined below, became effective on February 9, 2016.

(2)

The amounts represent external expenditures, including amortization of an intangible asset, and exclude salaries and benefits, share-based compensation, facilities, depreciation and laboratory supplies, as the majority of such costs are not directly charged to programs.

(3)

As a result of the cost-sharing provisions of the Mylan Collaboration Agreement, the Company offset approximately $3.7 million against research and development costs and $0.1 million against general and administrative costs during the three months ended March 31, 2016.

2003 Sandoz Collaboration Agreement

2006 Sandoz Collaboration Agreement

Baxalta Collaboration Agreement

The Baxalta Collaboration Agreement may be terminated by:

either party for breach by or bankruptcy of the other party;

Baxalta for its convenience; or

the Company in the event Baxalta does not exercise commercially reasonable efforts to commercialize M923 in the United States or other specified countries, provided that the Company also has certain rights to directly commercialize M923, as opposed to terminating the Baxalta Collaboration Agreement, in event of such a breach by Baxalta.

The regulatory milestones, along with any associated royalty or profit sharing payments, will be considered contingent fees that will be recorded as earned in future periods.

Mylan Collaboration Agreement

In accordance with FASB’s ASU No. 2009-13: Multiple-Deliverable Revenue Arrangements (Topic 615), the Company identified the deliverables at the inception of the Mylan Collaboration Agreement. The deliverables were determined to include (i) six development and product licenses, for each of M834 and the five additional collaboration products, (ii) research and development services related to each of M834 and the five additional collaboration products and (iii) the Company’s participation in the joint steering committee. The Company has determined that each of the license deliverables does not have stand-alone value apart from the related research and development services deliverables because (1) there are no other vendors selling similar, competing products on a stand-alone basis, (2) Mylan does not have the contractual right to resell the license, and (3) Mylan is unable to use the license for its intended purpose without the Company’s performance of research and development services. As such, the Company determined that with respect to this arrangement separate units of accounting exist for each of the six licenses together with the related research and development services, or the combined units of accounting, as well as a separate unit of accounting for participation in the joint steering committee. VSOE and TPE were not available for the combined units of accounting. As such, the Company determined BESP for the combined units of accounting based on an analysis of its existing license arrangements and other available data and the nature and extent of the research and development services to be performed. BESP for the joint steering committee unit of accounting was based on market rates for similar services. At the inception of the Mylan Collaboration Agreement, total arrangement consideration of $45 million was allocated to each of the units of accounting based on the relative selling price method. Of the $45 million, $8.2 million was allocated to the M834 combined unit of accounting, between $5.7 million and $9.0 million to the five additional combined units of accounting, considering the products’ stage of development at the time the licenses were delivered. $51,000 was allocated to the joint steering committee unit of accounting. Changes in the key assumptions used to determine BESP for the units of accounting would not have a significant effect on the allocation of arrangement consideration.

Share-Based Payments

3 Months Ended

Mar. 31, 2016

Share-Based Payments

Share-Based Payments

6. Share-Based Payments

Share-Based Compensation

The following table summarizes share-based compensation expense (income) recorded in the three months ended March 31, 2016 and 2015 (in thousands):

Share-based compensation expense (income)	For the Three Months Ended March 31, 2016		For the Three Months Ended March 31, 2015
Outstanding employee and non-employee stock option grants	$	2,758	$	2,370
Outstanding restricted stock awards	1,958		(6,850		)
Employee stock purchase plan	112		95

Total compensation expense (income)	$	4,828	$	(4,385	)

The following table summarizes the weighted average assumptions the Company used in its fair value calculations at the date of grant:

	Weighted Average Assumptions
	Stock Options				Employee Stock Purchase Plan
	For the Three Months Ended March 31, 2016		For the Three Months Ended March 31, 2015		For the Three Months Ended March 31, 2016		For the Three Months Ended March 31, 2015
Expected volatility	57	%	61	%	56	%	61	%
Expected dividends	—		—		—		—
Expected life (years)	6.1		6.2		0.5		0.5
Risk-free interest rate	1.6	%	1.8	%	0.4	%	0.1	%

Restricted Stock Awards

A summary of the status of nonvested shares of restricted stock as of March 31, 2016 and the changes during the three months then ended are presented below (in thousands, except fair values):

	Number of Shares		Weighted Average Grant Date Fair Value
Nonvested at January 1, 2016	761		$	14.61
Granted	387		10.83
Vested	(104	)	14.11
Forfeited	(22	)	14.07


Nonvested at March 31, 2016	1,022		$	13.24

Nonvested shares of restricted stock that have time-based or both performance-based and time-based vesting conditions as of March 31, 2016 are summarized below (in thousands):

Vesting Schedule		Nonvested Shares
Time-based		714
Performance-based and time-based		308


Nonvested at March 31, 2016		1,022

Equity Financings	3 Months Ended
Equity Financings	Mar. 31, 2016
Equity Financings
Equity Financings	7. Equity Financings In May 2014, the Company entered into an At-the-Market Equity Offering Sales Agreement, or the 2014 ATM Agreement, with Stifel, Nicolaus & Company, Incorporated, or Stifel, under which the Company was authorized to issue and sell shares of its common stock having aggregate sales proceeds of up to $75 million from time to time through Stifel, acting as sales agent and/or principal. The Company paid Stifel a commission of 2.0% of the gross proceeds from the sale of shares of its common stock under this facility. The offering was conducted by the Company pursuant to an effective shelf registration statement previously filed with the Securities and Exchange Commission (Reg. No. 333-188227) and a related prospectus supplement. The Company intends to use the net proceeds from this facility to advance its development pipeline and for general corporate purposes, including working capital. In the three months ended March 31, 2015, the Company sold approximately 2.6 million shares of common stock under the 2014 ATM Agreement, raising aggregate net proceeds of approximately $33.7 million. The Company concluded sales under the 2014 ATM Agreement in April 2015. Between October 2014 and April 2015, the Company sold approximately 5.4 million shares of common stock under the 2014 ATM Agreement, raising aggregate net proceeds of approximately $73.5 million. In April 2015, the Company entered into a new ATM Agreement, or the 2015 ATM Agreement, with Stifel, under which the Company is authorized to issue and sell shares of its common stock having aggregate sales proceeds of up to $75 million from time to time through Stifel, acting as sales agent and/or principal. The Company is required to pay Stifel a commission of 2.0% of the gross proceeds from the sale of shares of its common stock under the 2015 ATM Agreement. Sales of common stock under this facility have been made pursuant to an effective shelf registration statement previously filed with the Securities and Exchange Commission (Reg. No. 333-188227) and a related prospectus supplement. Between April 2015 and December 2015, the Company sold approximately 0.5 million shares of common stock under the 2015 ATM Agreement, raising aggregate net proceeds of approximately $9.3 million. No shares were sold under the 2015 ATM Agreement in the three months ended March 31, 2016.

Commitments and Contingencies	3 Months Ended
Commitments and Contingencies	Mar. 31, 2016
Commitments and Contingencies
Commitments and Contingencies	8. Commitments and Contingencies The disclosures relating to the Company’s operating lease obligations are included in its Annual Report on Form 10-K for the year ended December 31, 2015, filed with the Securities and Exchange Commission on February 26, 2016. Legal Contingencies The Company is involved in various litigation matters that arise from time to time in the ordinary course of business. The process of resolving matters through litigation or other means is inherently uncertain and it is possible that an unfavorable resolution of these matters will adversely affect the Company, its results of operations, financial condition and cash flows. The Company’s general practice is to expense legal fees as services are rendered in connection with legal matters, and to accrue for liabilities when losses are probable and reasonably estimable. The Company evaluates, on a quarterly basis, developments in legal proceedings and other matters that could cause an increase or decrease in the amount of any accrual on its consolidated balance sheets. M356-Related Litigation On September 10, 2014, Teva Pharmaceuticals Industries Ltd. and related entities, or Teva, and Yeda Research and Development Co., Ltd., or Yeda, filed suit against the Company and Sandoz Inc. in the United States Federal District Court in the District of Delaware in response to the filing by Sandoz Inc. of the ANDA with a Paragraph IV certification for M356. The suit initially alleged infringement related to two Orange Book-listed patents for COPAXONE 40 mg/mL, each expiring in 2030, and seeks declaratory and injunctive relief prohibiting the launch of the Company’s product until the last to expire of these patents. In April 2015, Teva and Yeda filed an additional suit against the Company and Sandoz Inc. in the United States District Court for the District of Delaware alleging infringement related to a third Orange Book-listed patent for COPAXONE 40 mg/mL, which issued in March 2015 and expires in 2030. In May 2015, this suit was consolidated with the initial suit filed in September 2014. In November 2015, Teva and Yeda filed a suit against the Company and Sandoz Inc. in the United States District Court for the District of Delaware alleging infringement related to a fourth Orange Book-listed patent for COPAXONE 40 mg/mL, which issued in October 2015 and expires in 2030. Teva and Yeda seek declaratory and injunctive relief prohibiting the launch of M356 until the expiration of this patent. In December 2015, this suit was consolidated with the initial suit filed in September 2014. The Company and Sandoz Inc. have asserted various defenses and filed counterclaims for declaratory judgments of non-infringement, invalidity and unenforceability of the COPAXONE 40 mg/mL patents. A pre-trial claim construction hearing was held in February 2016 and the trial is scheduled to begin in September 2016. Enoxaparin Sodium Injection-related Litigation On September 21, 2011, the Company and Sandoz Inc. sued Amphastar and Actavis, in the United States District Court for the District of Massachusetts for infringement of two of the Company’s patents. Also in September, 2011, the Company filed a request for a temporary restraining order and preliminary injunction to prevent Amphastar and Actavis from selling their enoxaparin product in the United States. In October 2011, the District Court granted the Company’s motion for a preliminary injunction and entered an order enjoining Amphastar and Actavis from advertising, offering for sale or selling their enoxaparin product in the United States until the conclusion of a trial on the merits and required the Company and Sandoz Inc. to post a security bond of $100 million in connection with the litigation. Amphastar and Actavis appealed the decision to the Court of Appeals for the Federal Circuit, or CAFC, and in January 2012, the CAFC stayed the preliminary injunction. In August 2012, the CAFC vacated the preliminary injunction and remanded the case to the District Court. In September 2012, the Company filed a petition with the CAFC for a rehearing by the full court en banc, which was denied. In February 2013, the Company filed a petition for a writ of certiorari for review of the CAFC decision by the United States Supreme Court and in June 2013 the Supreme Court denied the petition. In July 2013, the District Court granted a motion by Amphastar and Actavis for summary judgment. The Company filed a notice of appeal of that decision to the CAFC. In February 2014, Amphastar filed a motion to the CAFC for summary affirmance of the District Court ruling, which the CAFC denied in May 2014. On November 10, 2015, the CAFC affirmed the District Court summary judgment decision with respect to Actavis, reversed the District Court summary judgment decision with respect to Amphastar, and remanded the case against Amphastar to the District Court. On January 11, 2016, Amphastar filed a petition for rehearing by the CAFC, which was denied on February 17, 2016. The collateral for the security bond posted in the litigation remains outstanding. In the event that the Company is not successful in further prosecution or settlement of this action against Amphastar, and Amphastar is able to prove they suffered damages as a result of the preliminary injunction, the Company could be liable for damages for up to $35 million of the security bond. Amphastar has filed motions to increase the amount of the security bond, which the Company and Sandoz Inc. have opposed. On September 17, 2015, Amphastar filed a complaint against the Company and Sandoz Inc. in the United States District Court for the Central District of California. The complaint alleges that, in connection with filing the September 2011 patent infringement suit against Amphastar and Actavis, the Company and Sandoz Inc. sought to prevent Amphastar from selling generic enoxaparin sodium injection and thereby exclude competition for generic enoxaparin sodium injection in violation of federal and California anti-trust laws and California unfair business laws. Amphastar is seeking unspecified damages and fees. In December 2015, the Company and Sandoz Inc. filed a motion to dismiss and a motion to transfer the case. In January 2016, the case was transferred to the United States District Court for the District of Massachusetts. In February 2016, Amphastar filed a writ of mandamus with the United States Court of Appeals for the Ninth Circuit requesting the court to reverse and review the District Court’s grant of transfer. While the outcome of litigation is inherently uncertain, the Company believes this suit is without merit, and the Company intends to vigorously defend itself in this litigation. On October 14, 2015, The Hospital Authority of Metropolitan Government of Nashville and Davidson County, Tennessee, d/b/a Nashville General Hospital, or NGH, filed a class action suit against the Company and Sandoz Inc. in the United States District Court for the Middle District of Tennessee on behalf of certain purchasers of LOVENOX or generic enoxaparin sodium injection. The complaint alleges that, in connection with filing the September 2011 patent infringement suit against Amphastar and Actavis, the Company and Sandoz Inc. sought to prevent Amphastar from selling generic enoxaparin sodium injection and thereby exclude competition for generic enoxaparin sodium injection in violation of federal anti-trust laws. NGH is seeking injunctive relief, disgorgement of profits and unspecified damages and fees. In December 2015, the Company and Sandoz Inc. filed a motion to dismiss and a motion to transfer the case to the United States District Court for the District of Massachusetts. Hearings on the motions were held in February 2016 on the motion to transfer and in April 2016 on the motion to dismiss, before a United States magistrate. These motions are pending before the magistrate and subject to review by the court. While the outcome of litigation is inherently uncertain, the Company believes this suit is without merit, and it intends to vigorously defend itself in this litigation.

Summary of Significant Accounting Policies (Policies)

3 Months Ended

Mar. 31, 2016

Summary of Significant Accounting Policies

Basis of Presentation and Principles of Consolidation

Use of Estimates

Revenue Recognition

Up-Front License Fees

Milestones

The regulatory milestones under the collaboration with Baxalta are considered to be contingent fees that will be recorded if earned in future periods.

Sales-based and commercial milestones are accounted for as royalties and are recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met.

Profit Share and Royalties on Sandoz’ Sales of Enoxaparin Sodium Injection® and GLATOPA®

Research and Development Revenue under Collaborations with Sandoz and Baxalta

Collaboration Receivable

Collaboration receivable represents:

Amounts due to the Company for profit share on Sandoz’ sales of Enoxaparin Sodium Injection and GLATOPA;

Amounts due to the Company for reimbursement of research and development services and external costs under the collaborations with Sandoz and Baxalta; and

The net amount due from Mylan for its 50% share of collaboration expenses under the cost-sharing arrangement.

The Company has not recorded any allowance for uncollectible accounts or bad debt write-offs and it monitors its receivables to facilitate timely payment.

Deferred Revenue

Deferred revenue represents consideration received from collaborators in advance of achieving certain criteria that must be met for revenue to be recognized in conformity with GAAP.

Net Loss Per Common Share

The following table presents anti-dilutive shares for the three months ended March 31, 2016 and 2015 (in thousands):

	Three Months Ended March 31,
	2016	2015
Weighted-average anti-dilutive shares related to:
Outstanding stock options	6,659	6,519
Restricted stock awards	335	685

Fair Value Measurements

Description	Balance as of March 31, 2016		Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Other Unobservable Inputs (Level 3)
Assets:
Cash equivalents:
Money market funds and overnight repurchase agreements	$	86,685	$	62,685	$	24,000	$	—
Marketable securities:
U.S. government-sponsored enterprise securities	4,999		—		4,999		—
Corporate debt securities	74,479		—		74,479		—
Commercial paper obligations	111,578		—		111,578		—
Asset-backed securities	82,341		—		82,341		—


Total	$	360,082	$	62,685	$	297,397	$	—

Description	Balance as of December 31, 2015		Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Other Unobservable Inputs (Level 3)
Assets:
Cash equivalents:
Money market funds and overnight repurchase agreements	$	54,077	$	30,077	$	24,000	$	—
Marketable securities:
U.S. government-sponsored enterprise securities	24,290		—		24,290		—
Corporate debt securities	73,651		—		73,651		—
Commercial paper obligations	125,805		—		125,805		—
Asset-backed securities	64,837		—		64,837		—


Total	$	342,660	$	30,077	$	312,583	$	—

There have been no impairments of the Company’s assets measured and carried at fair value during the three months ended March 31, 2016 and 2015. In addition, there were no changes in valuation techniques or transfers between the fair value measurement levels during the three months ended March 31, 2016. The fair value of Level 2 instruments classified as marketable securities were determined through third party pricing services. For a description of the Company’s validation procedures related to prices provided by third party pricing services, refer to Note 2 “ Summary of Significant Accounting Policies: Fair Value Measurements “ to the Company’s consolidated financial statements in its Annual Report on Form 10-K for the year ended December 31, 2015. The carrying amounts reflected in the Company’s accompanying condensed consolidated balance sheets for cash, accounts receivable, unbilled receivables, other current assets, accounts payable and accrued expenses approximate fair value due to their short-term maturities.

Cash, Cash Equivalents and Marketable Securities

The Company’s cash equivalents are primarily composed of money market funds carried at fair value, which approximates cost at March 31, 2016 and December 31, 2015. The Company classifies corporate debt securities, commercial paper, asset-backed securities and U.S. government-sponsored enterprise securities as short-term and long-term marketable securities in its consolidated financial statements. See Note 2 “Summary of Significant Accounting Policies: Cash, Cash Equivalents and Marketable Securities” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 for a discussion of the Company’s accounting policies.

The following tables summarize the Company’s cash, cash equivalents and marketable securities as of March 31, 2016 and December 31, 2015 (in thousands):

As of March 31, 2016	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
Cash, money market funds and overnight repurchase agreements	$	89,431	$	—	$	—		$	89,431
U.S. government-sponsored enterprise securities due in one year or less	4,998		1		—			4,999
Corporate debt securities due in one year or less	74,473		8		(2		)	74,479
Commercial paper obligations due in one year or less	111,449		129		—			111,578
Asset-backed securities due in one year or less	65,302		15		(14		)	65,303
Asset-backed securities due in two years or less	17,038		4		(4		)	17,038


Total	$	362,691	$	157	$	(20	)	$	362,828


Reported as:
Cash and cash equivalents	$	89,431	$	—	$	—		$	89,431
Marketable securities	273,260		157		(20		)	273,397


Total	$	362,691	$	157	$	(20	)	$	362,828

As of December 31, 2015	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
Cash, money market funds and overnight repurchase agreements	$	61,461	$	—	$	—		$	61,461
U.S. government-sponsored enterprise securities due in one year or less	24,285		5		—			24,290
Corporate debt securities due in one year or less	73,735		1		(84		)	73,652
Commercial paper obligations due in one year or less	125,693		120		(8		)	125,805
Asset-backed securities due in one year or less	64,866		—		(30		)	64,836


Total	$	350,040	$	126	$	(122	)	$	350,044


Reported as:
Cash and cash equivalents	$	61,461	$	—	$	—		$	61,461
Marketable securities	288,579		126		(122		)	288,583


Total	$	350,040	$	126	$	(122	)	$	350,044

The following table summarizes the aggregate fair value of these securities as of March 31, 2016 and December 31, 2015 (in thousands):

	As of March 31, 2016					As of December 31, 2015
	Aggregate Fair Value		Unrealized Losses			Aggregate Fair Value		Unrealized Losses
Corporate debt securities due in one year or less	$	20,024	$	(2	)	$	70,657	$	(84	)
Commercial paper obligations due in one year or less	$	—	$	—		$	33,734	$	(8	)
Asset-backed securities due in one year or less	$	22,944	$	(14	)	$	61,337	$	(30	)
Asset-backed securities due in two years or less	$	8,015	$	(4	)	$	—	$	—

Treasury Stock

Comprehensive Income (Loss)

New Accounting Pronouncements

Summary of Significant Accounting Policies (Tables)

3 Months Ended

Mar. 31, 2016

Summary of Significant Accounting Policies

Schedule of anti-dilutive shares

The following table presents anti-dilutive shares for the three months ended March 31, 2016 and 2015 (in thousands):

	Three Months Ended March 31,
	2016	2015
Weighted-average anti-dilutive shares related to:
Outstanding stock options	6,659	6,519
Restricted stock awards	335	685

Schedule of assets measured at fair value on a recurring basis

Description	Balance as of March 31, 2016		Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Other Unobservable Inputs (Level 3)
Assets:
Cash equivalents:
Money market funds and overnight repurchase agreements	$	86,685	$	62,685	$	24,000	$	—
Marketable securities:
U.S. government-sponsored enterprise securities	4,999		—		4,999		—
Corporate debt securities	74,479		—		74,479		—
Commercial paper obligations	111,578		—		111,578		—
Asset-backed securities	82,341		—		82,341		—


Total	$	360,082	$	62,685	$	297,397	$	—

Description	Balance as of December 31, 2015		Quoted Prices in Active Markets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Other Unobservable Inputs (Level 3)
Assets:
Cash equivalents:
Money market funds and overnight repurchase agreements	$	54,077	$	30,077	$	24,000	$	—
Marketable securities:
U.S. government-sponsored enterprise securities	24,290		—		24,290		—
Corporate debt securities	73,651		—		73,651		—
Commercial paper obligations	125,805		—		125,805		—
Asset-backed securities	64,837		—		64,837		—


Total	$	342,660	$	30,077	$	312,583	$	—

Schedule of reconciliation of cash, cash equivalents and marketable securities from amortized cost to fair value

The following tables summarize the Company’s cash, cash equivalents and marketable securities as of March 31, 2016 and December 31, 2015 (in thousands):

As of March 31, 2016	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
Cash, money market funds and overnight repurchase agreements	$	89,431	$	—	$	—		$	89,431
U.S. government-sponsored enterprise securities due in one year or less	4,998		1		—			4,999
Corporate debt securities due in one year or less	74,473		8		(2		)	74,479
Commercial paper obligations due in one year or less	111,449		129		—			111,578
Asset-backed securities due in one year or less	65,302		15		(14		)	65,303
Asset-backed securities due in two years or less	17,038		4		(4		)	17,038


Total	$	362,691	$	157	$	(20	)	$	362,828


Reported as:
Cash and cash equivalents	$	89,431	$	—	$	—		$	89,431
Marketable securities	273,260		157		(20		)	273,397


Total	$	362,691	$	157	$	(20	)	$	362,828

As of December 31, 2015	Amortized Cost		Gross Unrealized Gains		Gross Unrealized Losses			Fair Value
Cash, money market funds and overnight repurchase agreements	$	61,461	$	—	$	—		$	61,461
U.S. government-sponsored enterprise securities due in one year or less	24,285		5		—			24,290
Corporate debt securities due in one year or less	73,735		1		(84		)	73,652
Commercial paper obligations due in one year or less	125,693		120		(8		)	125,805
Asset-backed securities due in one year or less	64,866		—		(30		)	64,836


Total	$	350,040	$	126	$	(122	)	$	350,044


Reported as:
Cash and cash equivalents	$	61,461	$	—	$	—		$	61,461
Marketable securities	288,579		126		(122		)	288,583


Total	$	350,040	$	126	$	(122	)	$	350,044

Schedule of aggregate fair value and unrealized losses on marketable securities

The following table summarizes the aggregate fair value of these securities as of March 31, 2016 and December 31, 2015 (in thousands):

	As of March 31, 2016					As of December 31, 2015
	Aggregate Fair Value		Unrealized Losses			Aggregate Fair Value		Unrealized Losses
Corporate debt securities due in one year or less	$	20,024	$	(2	)	$	70,657	$	(84	)
Commercial paper obligations due in one year or less	$	—	$	—		$	33,734	$	(8	)
Asset-backed securities due in one year or less	$	22,944	$	(14	)	$	61,337	$	(30	)
Asset-backed securities due in two years or less	$	8,015	$	(4	)	$	—	$	—

Intangible Assets (Tables)

3 Months Ended

Mar. 31, 2016

Intangible Assets

Schedule of intangible assets, net of accumulated amortization

As of March 31, 2016 and December 31, 2015, intangible assets, net of accumulated amortization, were as follows (in thousands):

	March 31, 2016							December 31, 2015
	Gross Carrying Amount		Accumulated Amortization			Net Carrying Value		Gross Carrying Amount		Accumulated Amortization			Net Carrying Value
Total intangible assets for core and developed technology and non-compete agreement	$	10,427	$	(7,164	)	$	3,263	$	10,427	$	(6,899	)	$	3,528

Collaboration and License Agreements (Tables)

3 Months Ended

Mar. 31, 2016

Collaborations and License Agreements

Schedules of tables providing amounts included in the company's condensed consolidated statements of operations and comprehensive loss attributable to transactions arising from its collaborative arrangements

The following tables provide amounts by year and by line item included in the Company’s accompanying condensed consolidated statements of operations and comprehensive loss attributable to transactions arising from its significant collaborative arrangements and all other arrangements, as defined in the Financial Accounting Standards Board’s Accounting Standards Codification Topic 808, Collaborative Arrangements.The dollar amounts in the tables below are in thousands.

	For the Three Months Ended March 31, 2016
	2003 Sandoz Collaboration Agreement		2006 Sandoz Collaboration Agreement		Baxalta Collaboration Agreement		Mylan Collaboration Agreement (1)		Total Collaborations
Collaboration revenues:
Product revenue	$	—	$	14,800	$	—	$	—	$	14,800

Research and development revenue:
Recognition of upfront payments and license payments	—		—		2,442		922		3,364
Research and development services and external costs under Sandoz and Baxalta collaborations	77		645		964		—		1,686

Total research and development revenue	$	77	$	645	$	3,406	$	922	$	5,050

Total collaboration revenues	$	77	$	15,445	$	3,406	$	922	$	19,850

Operating expenses:
Research and development expense(2)(3)	$	—	$	293	$	314	$	3,680	$	4,287
General and administrative expense(2)(3)	$	1,064	$	95	$	282	$	112	$	1,553

Total operating expenses	$	1,064	$	388	$	596	$	3,792	$	5,840

	For the Three Months Ended March 31, 2015
	2003 Sandoz Collaboration Agreement		2006 Sandoz Collaboration Agreement		Baxalta Collaboration Agreement		Total Collaborations
Collaboration revenues:
Product revenue	$	2,722	$	—	$	—	$	2,722

Research and development revenue:
Milestone payments	—		—		—		—
Recognition of upfront payments and license payments	—		—		1,686		1,686
Research and development services and external costs	251		684		3,219		4,154

Total research and development revenue	$	251	$	684	$	4,905	$	5,840

Total collaboration revenues	$	2,973	$	684	$	4,905	$	8,562

Operating expenses:
Research and development expense(2)	$	31	$	148	$	608	$	787
General and administrative expense(2)	$	110	$	77	$	406	$	593

Total operating expenses	$	141	$	225	$	1,014	$	1,380

(1)

The Mylan Collaboration Agreement, as defined below, became effective on February 9, 2016.

(2)

(3)

Share-Based Payments (Tables)

3 Months Ended

Mar. 31, 2016

Share-Based Payments

Summary of share-based compensation expense (income)

The following table summarizes share-based compensation expense (income) recorded in the three months ended March 31, 2016 and 2015 (in thousands):

Share-based compensation expense (income)	For the Three Months Ended March 31, 2016		For the Three Months Ended March 31, 2015
Outstanding employee and non-employee stock option grants	$	2,758	$	2,370
Outstanding restricted stock awards	1,958		(6,850		)
Employee stock purchase plan	112		95

Total compensation expense (income)	$	4,828	$	(4,385	)

Schedule of weighted average assumptions

	Weighted Average Assumptions
	Stock Options				Employee Stock Purchase Plan
	For the Three Months Ended March 31, 2016		For the Three Months Ended March 31, 2015		For the Three Months Ended March 31, 2016		For the Three Months Ended March 31, 2015
Expected volatility	57	%	61	%	56	%	61	%
Expected dividends	—		—		—		—
Expected life (years)	6.1		6.2		0.5		0.5
Risk-free interest rate	1.6	%	1.8	%	0.4	%	0.1	%

Schedule of nonvested shares of restricted stock

A summary of the status of nonvested shares of restricted stock as of March 31, 2016 and the changes during the three months then ended are presented below (in thousands, except fair values):

	Number of Shares		Weighted Average Grant Date Fair Value
Nonvested at January 1, 2016	761		$	14.61
Granted	387		10.83
Vested	(104	)	14.11
Forfeited	(22	)	14.07


Nonvested at March 31, 2016	1,022		$	13.24

Summarized information about time-based or performance-based vesting schedules

Nonvested shares of restricted stock that have time-based or both performance-based and time-based vesting conditions as of March 31, 2016 are summarized below (in thousands):

Vesting Schedule		Nonvested Shares
Time-based		714
Performance-based and time-based		308


Nonvested at March 31, 2016		1,022

Summary of Significant Accounting Policies - Collaboration Receivable (Details)	3 Months Ended
	Mar. 31, 2016
Mylan Agreement
Collaboration Receivable
Percentage of cost sharing arrangement under collaborative and license agreements	50.00%

Summary of Significant Accounting Policies - Net loss per common share (Details) - shares	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Outstanding Stock options
Weighted-average anti-dilutive shares related to:
Antidilutive securities excluded from computation of earnings per share (in shares)	6,659,000	6,519,000
Restricted stock awards
Weighted-average anti-dilutive shares related to:
Antidilutive securities excluded from computation of earnings per share (in shares)	335,000	685,000
Performance-based restricted stock awards, M356
Weighted-average anti-dilutive shares related to:
Antidilutive securities excluded from computation of earnings per share (in shares)	308,095
Performance-based restricted stock awards, M356 \| Awards vesting on the one-year anniversary of approval from FDA
Weighted-average anti-dilutive shares related to:
Award vesting period	1 year

Summary of Significant Accounting Policies - Fair Value Measurement - (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015	Dec. 31, 2015
Fair Value Measurements
Transfer from Level 1 to Level 2, assets	$ 0
Transfer from Level 2 to Level 1, assets	0
Other-than-temporary impairment	0	$ 0
Recurring \| Fair value
Fair Value Measurements
Assets fair value	360,082		$ 342,660
Recurring \| Fair value \| Money market funds and overnight repurchase agreements
Fair Value Measurements
Assets fair value	86,685		54,077
Recurring \| Fair value \| U.S. government-sponsored enterprise securities:
Fair Value Measurements
Assets fair value	4,999		24,290
Recurring \| Fair value \| Corporate debt securities
Fair Value Measurements
Assets fair value	74,479		73,651
Recurring \| Fair value \| Commercial paper obligations
Fair Value Measurements
Assets fair value	111,578		125,805
Recurring \| Fair value \| Asset-backed securities
Fair Value Measurements
Assets fair value	82,341		64,837
Recurring \| Quoted Prices in Active Markets (Level 1)
Fair Value Measurements
Assets fair value	62,685		30,077
Recurring \| Quoted Prices in Active Markets (Level 1) \| Money market funds and overnight repurchase agreements
Fair Value Measurements
Assets fair value	62,685		30,077
Recurring \| Significant Other Observable Inputs (Level 2)
Fair Value Measurements
Assets fair value	297,397		312,583
Recurring \| Significant Other Observable Inputs (Level 2) \| Money market funds and overnight repurchase agreements
Fair Value Measurements
Assets fair value	24,000		24,000
Recurring \| Significant Other Observable Inputs (Level 2) \| U.S. government-sponsored enterprise securities:
Fair Value Measurements
Assets fair value	4,999		24,290
Recurring \| Significant Other Observable Inputs (Level 2) \| Corporate debt securities
Fair Value Measurements
Assets fair value	74,479		73,651
Recurring \| Significant Other Observable Inputs (Level 2) \| Commercial paper obligations
Fair Value Measurements
Assets fair value	111,578		125,805
Recurring \| Significant Other Observable Inputs (Level 2) \| Asset-backed securities
Fair Value Measurements
Assets fair value	$ 82,341		$ 64,837

Summary of Significant Accounting Policies - Cash, Cash Equivalents (Details) - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015	Mar. 31, 2015	Dec. 31, 2014
Cash, Cash Equivalents and Marketable Securities:
Cash and cash equivalents/money market funds	$ 89,431	$ 61,461
Cash and cash equivalents/money market funds, Fair Value	89,431	61,461	$ 97,608	$ 61,349
Cash, cash equivalents and marketable securities, Amortized Cost	362,691	350,040
Cash, cash equivalents and marketable securities, gross unrealized gains	157	126
Cash, cash equivalents and marketable securities, gross unrealized losses	(20)	(122)
Cash, cash equivalents and marketable securities, Fair Value	362,828	350,044
Marketable securities, Amortized Cost	273,260	288,579
Marketable securities, Gross Unrealized Gains	157	126
Marketable securities, Gross Unrealized Losses	(20)	(122)
Marketable securities, Fair Value	273,397	288,583
Cash, money market funds and overnight repurchase agreements
Cash, Cash Equivalents and Marketable Securities:
Cash and cash equivalents/money market funds	89,431	61,461
Cash and cash equivalents/money market funds, Fair Value	89,431	61,461
U.S. government-sponsored enterprise securities:
Cash, Cash Equivalents and Marketable Securities:
Available for sale securities, Due in one year or less, Amortized Cost	4,998	24,285
Available for sale securities, Due in one year or less, Gross Unrealized Gains	1	5
Available for sale securities, Due in one year or less, Fair Value	4,999	24,290
Corporate debt securities
Cash, Cash Equivalents and Marketable Securities:
Available for sale securities, Due in one year or less, Amortized Cost	74,473	73,735
Available for sale securities, Due in one year or less, Gross Unrealized Gains	8	1
Available for sale securities, Due in one year or less, Gross Unrealized Losses	(2)	(84)
Available for sale securities, Due in one year or less, Fair Value	74,479	73,652
Commercial paper obligations
Cash, Cash Equivalents and Marketable Securities:
Available for sale securities, Due in one year or less, Amortized Cost	111,449	125,693
Available for sale securities, Due in one year or less, Gross Unrealized Gains	129	120
Available for sale securities, Due in one year or less, Gross Unrealized Losses		(8)
Available for sale securities, Due in one year or less, Fair Value	111,578	125,805
Asset-backed securities
Cash, Cash Equivalents and Marketable Securities:
Available for sale securities, Due in one year or less, Amortized Cost	65,302	64,866
Available for sale securities, Due in two years or less, Amortized Cost	17,038
Available for sale securities, Due in one year or less, Gross Unrealized Gains	15
Available for sale securities, Due in two years or less, Gross Unrealized Gains	4
Available for sale securities, Due in one year or less, Gross Unrealized Losses	(14)	(30)
Available for sale securities, Due in two years or less, Gross Unrealized Losses	(4)
Available for sale securities, Due in one year or less, Fair Value	65,303	$ 64,836
Available for sale securities, Due in two years or less, Fair Value	$ 17,038

Summary of Significant Accounting Policies- Unrealized loss (Details) $ in Thousands	Mar. 31, 2016 USD ($) item	Dec. 31, 2015 USD ($) item
Unrealized loss position for less than one year
Number of marketable securities in an unrealized loss position for less than one year \| item	11	66
Number of marketable securities in an unrealized loss position for greater than one year \| item	0	0
Corporate debt securities \| Due in one year or less
Unrealized loss position for less than one year
Aggregate Fair Value	$ 20,024	$ 70,657
Unrealized Losses	(2)	(84)
Commercial paper obligations \| Due in one year or less
Unrealized loss position for less than one year
Aggregate Fair Value		33,734
Unrealized Losses		(8)
Asset-backed securities \| Due in one year or less
Unrealized loss position for less than one year
Aggregate Fair Value	22,944	61,337
Unrealized Losses	(14)	$ (30)
Asset-backed securities \| Due in two years or less
Unrealized loss position for less than one year
Aggregate Fair Value	8,015
Unrealized Losses	$ (4)

Intangible Assets (Details) $ in Thousands	3 Months Ended
Intangible Assets (Details) $ in Thousands	Mar. 31, 2016 USD ($) item	Mar. 31, 2015 USD ($)	Dec. 31, 2015 USD ($)
Intangible Assets
Weighted-Average Amortization Period	10 years
Gross Carrying Amount	$ 10,427		$ 10,427
Accumulated Amortization	(7,164)		(6,899)
Net Carrying Value	$ 3,263		$ 3,528
Number of other patterns \| item	0
Amortization expense	$ 265	$ 265
Expected amortization expense for year one	1,100
Expected amortization expense for year two	1,100
Expected amortization expense for year three	1,100
Expected amortization expense for year four	$ 100

Restricted Cash (Details) - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015
Restricted cash
Restricted cash	$ 20,660	$ 20,660
Security Bond Collateral
Restricted cash
Restricted cash	17,500
Lease Collateral \| 675 West Kendall Street
Restricted cash
Restricted cash	2,400
Lease Collateral \| 320 Bent Street
Restricted cash
Restricted cash	$ 700

Collaboration and License Agreements (Details)	1 Months Ended	3 Months Ended		9 Months Ended
Collaboration and License Agreements (Details)	Feb. 28, 2015 USD ($)	Mar. 31, 2016 USD ($) item	Mar. 31, 2015 USD ($)	Sep. 30, 2015 USD ($)
Collaboration revenues:
Product revenue		$ 14,800,000	$ 2,722,000
Research and development revenue
Recognition of upfront payments and license payments		3,364,000	1,686,000
Research and development services (FTEs) and external costs		1,686,000	4,154,000
Total research and development revenue		5,050,000	5,840,000
Total collaboration revenue		19,850,000	8,562,000
Operating expenses:
Research and Development Expense		4,287,000	787,000
General and Administrative Expense		1,553,000	593,000
Total Operating expenses		5,840,000	1,380,000
2003 Sandoz Collaboration
Collaboration revenues:
Product revenue			2,722,000
Research and development revenue
Research and development services (FTEs) and external costs		77,000	251,000
Total research and development revenue		77,000	251,000
Total collaboration revenue		77,000	2,973,000
Operating expenses:
Research and Development Expense			31,000
General and Administrative Expense		1,064,000	110,000
Total Operating expenses		$ 1,064,000	$ 141,000
Percentage of royalty for net sales up to pre-defined sales threshold			10.00%
Percentage of royalty based on contractually defined profits on sales			50.00%
Maximum percentage of reduction of profit-share, royalty and milestone payments from Sandoz at each quarter		50.00%
Second Sandoz Collaboration Agreement
Collaboration revenues:
Product revenue		$ 14,800,000
Research and development revenue
Research and development services (FTEs) and external costs		645,000	$ 684,000
Total research and development revenue		645,000	684,000
Total collaboration revenue		15,445,000	684,000
Operating expenses:
Research and Development Expense		293,000	148,000
General and Administrative Expense		95,000	77,000
Total Operating expenses		$ 388,000	225,000
Percentage of royalty based on contractually defined profits on sales		50.00%
Second Sandoz Collaboration Agreement \| Maximum
Operating expenses:
Milestone payments possible per agreement		$ 120,000,000
Second Sandoz Collaboration Agreement \| Novartis Pharma AG
Operating expenses:
Percentage of contractual profits earned under collaborative arrangement		50.00%
Baxalta Agreement
Research and development revenue
Recognition of upfront payments and license payments		$ 2,442,000	1,686,000
Research and development services (FTEs) and external costs		964,000	3,219,000
Total research and development revenue		3,406,000	4,905,000
Total collaboration revenue		3,406,000	4,905,000
Operating expenses:
Research and Development Expense		314,000	608,000
General and Administrative Expense		282,000	406,000
Total Operating expenses		$ 596,000	$ 1,014,000
Number of additional biosimilars under the agreement \| item		4
Upfront payment paid by Baxter to the company		$ 33,000,000
Option payments agreed to be paid by Baxter with respect to additional product candidates		12,000,000
Option payment which the entity is no longer eligible to receive		7,000,000
Remaining payment obligation		$ 0
Number of additional follow-on biologic products for research and development services \| item		4
Baxalta Agreement \| Accounting Standards Update 2009 to 2013 Member
Operating expenses:
Number of significant deliverables identified in arrangement \| item		7
Total arrangement consideration	$ 61,000,000	$ 61,000,000		$ 61,000,000
Portion of revised arrangement consideration reallocated to the remaining deliverables	40,000,000	61,000,000
Portion of revised arrangement consideration allocated to the first initial product license as a result of termination of product	39,600,000	10,300,000
Portion of revised arrangement consideration allocated to each of the three additional product licenses as a result of termination of product	400,000	10,300,000
Portion of revised arrangement consideration allocated to the second initial product license as a result of termination of product		9,400,000
Portion of revised arrangement consideration allocated to the joint steering committee unit of accounting as a result of termination of product		114,000,000
Decrease in portion of revised arrangement consideration reallocated to the remaining deliverables	$ 40,000,000
Upfront payment paid by Baxter to the company		$ 33,000,000
Estimate performance period for the joint steering committee		6 years
Number of additional follow-on biologic products for development and product licenses \| item		4
Deferred revenue		$ 19,500,000
Deferred revenue included in current liabilities		9,800,000
Deferred revenue included in non-current liabilities		9,700,000
Baxalta Agreement \| Maximum
Operating expenses:
Aggregate regulatory milestone to be paid by Baxter		(50,000,000)
Mylan Agreement
Research and development revenue
Recognition of upfront payments and license payments		922,000
Total research and development revenue		922,000
Total collaboration revenue		922,000
Operating expenses:
Research and Development Expense		3,680,000
General and Administrative Expense		112,000
Total Operating expenses		$ 3,792,000
Percentage of cost sharing arrangement under collaborative and license agreements		50.00%
Amount of offset against research and development costs		$ 3,700,000
Amount of offset against general and administrative costs		100,000
Decrease in research and development expenses under cost sharing arrangement		3,700,000
Decrease in general and administrative expenses under cost sharing arrangement		$ 100,000
Number of years for ceasing agreement		2 years
Non-refundable upfront payment		$ 45,000,000
Milestone payment on collaboration agreement		200,000,000
Mylan Agreement \| Accounting Standards Update 2009 to 2013 Member
Operating expenses:
Total arrangement consideration		45,000,000
Portion of revised arrangement consideration reallocated to the remaining deliverables		45,000,000
Portion of revised arrangement consideration allocated to the first initial product license as a result of termination of product		8,200,000
Portion of revised arrangement consideration allocated to the joint steering committee unit of accounting as a result of termination of product		$ 51,000
Estimate performance period for the first initial product		4 years
Estimate performance period for the additional five product		7 years
Estimate performance period for the joint steering committee		8 years
Number of additional follow-on biologic products for development and product licenses \| item		5
Number of additional follow-on biologic products for research and development services \| item		5
Deferred revenue amortized to research and development revenue		$ 900,000
Deferred revenue included in current liabilities		7,400,000
Deferred revenue included in non-current liabilities		36,700,000
Mylan Agreement \| Minimum \| Accounting Standards Update 2009 to 2013 Member
Operating expenses:
Portion of revised arrangement consideration allocated to each of the three additional product licenses as a result of termination of product		5,700,000
Mylan Agreement \| Maximum \| Accounting Standards Update 2009 to 2013 Member
Operating expenses:
Portion of revised arrangement consideration allocated to each of the three additional product licenses as a result of termination of product		$ 9,000,000

Share-Based Payments - Incentive Award Plans (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Share-Based Payments
Allocated share-based compensation expense	$ 4,828
Allocated share-based compensation (income)		$ (4,385)
Members of the Board of Directors
Share-Based Payments
Granted (in shares)	60,000
Outstanding Stock options
Share-Based Payments
Allocated share-based compensation expense	$ 2,758	2,370
Restricted stock awards
Share-Based Payments
Allocated share-based compensation expense	$ 1,958
Allocated share-based compensation (income)		$ (6,850)
Stock options
Share-Based Payments
Granted (in shares)	975,152
Weighted average grant date fair value of options granted (in dollars per share)	$ 5.81	$ 7.49
Annual Merit Awards
Share-Based Payments
Granted (in shares)	774,302
New Hire Awards
Share-Based Payments
Granted (in shares)	140,850
Employee Stock Purchase Plan
Share-Based Payments
Allocated share-based compensation expense	$ 112	$ 95

Share-Based Payments - Weighted Average Assumptions (Details) - USD ($) $ / shares in Units, $ in Thousands				3 Months Ended		13 Months Ended
	Mar. 29, 2015	Mar. 28, 2015	Mar. 11, 2015	Mar. 31, 2016	Mar. 31, 2015	Mar. 31, 2016
Share-Based Payments
Allocated share-based compensation expense				$ 4,828
Additional disclosures
Proceeds from issuance of common stock under stock plans				$ 558	$ 2,911
Stock options
Weighted average assumptions used in fair value calculations
Expected volatility (as a percent)				57.00%	61.00%
Expected life (years)				6 years 1 month 6 days	6 years 2 months 12 days
Risk-free interest rate (as a percent)				1.60%	1.80%
Additional disclosures
Remaining unrecognized compensation cost related to nonvested awards				$ 18,300		$ 18,300
Weighted average remaining requisite service period				2 years 8 months 5 days
Employee Stock Purchase Plan
Share-Based Payments
Allocated share-based compensation expense				$ 112	$ 95
Weighted average assumptions used in fair value calculations
Expected volatility (as a percent)				56.00%	61.00%
Expected life (years)				6 months	6 months
Risk-free interest rate (as a percent)				0.40%	0.10%
Additional disclosures
Shares issued during period				52,116
Proceeds from issuance of common stock under stock plans				$ 600
Restricted stock awards
Share-Based Payments
Allocated share-based compensation expense				1,958
Cumulative share-based compensation					$ 10,500
Additional disclosures
Remaining unrecognized compensation cost related to nonvested awards				$ 200		$ 200
Non-vested shares of restricted stock, Number of Shares
Nonvested at the beginning of the period (in shares)				761,000
Granted (in shares)				387,000
Vested (in shares)				(104,000)
Forfeited (in shares)				(22,000)
Nonvested at the end of the period (in shares)				1,022,000		1,022,000
Non-vested shares of restricted stock, Weighted Average Grant Date Fair Value
Nonvested at the beginning of the period (in dollars per share)				$ 14.61
Granted (in dollars per share)				10.83
Vested (in dollars per share)				14.11
Forfeited (in dollars per share)				14.07
Nonvested at the end of the period (in dollars per share)				$ 13.24		$ 13.24
Time-based restricted stock awards
Additional disclosures
Remaining unrecognized compensation cost related to nonvested awards				$ 8,800		$ 8,800
Weighted average remaining requisite service period				2 years 2 months 23 days
Non-vested shares of restricted stock, Number of Shares
Nonvested at the end of the period (in shares)				714,000		714,000
Time-based restricted stock awards \| Awards vesting on the one-year anniversary
Share-Based Payments
Award vesting period				1 year
Additional disclosures
Vesting percentage				25.00%
Time-based restricted stock awards \| Awards vesting on the quarterly basis
Share-Based Payments
Award vesting period				3 years
Additional disclosures
Vesting percentage				6.25%
Time-based restricted stock awards \| Officers
Non-vested shares of restricted stock, Number of Shares
Granted (in shares)				387,321
Performance-based restricted stock awards
Share-Based Payments
Allocated share-based compensation expense		$ 10,500	$ 9,800			$ 9,100
Non-vested shares of restricted stock, Number of Shares
Forfeited (in shares)	(117,898)
Nonvested at the end of the period (in shares)				308,000		308,000
Performance-based restricted stock awards \| Shares vesting upon FDA approval
Additional disclosures
Vesting percentage			50.00%
Performance-based restricted stock awards \| Awards vesting on the one-year anniversary of approval from FDA
Share-Based Payments
Award vesting period				1 year
Percentage of forfeiture of original number of shares			15.00%
Additional disclosures
Vesting percentage		50.00%	50.00%
Performance-based restricted stock awards, M356
Non-vested shares of restricted stock, Number of Shares
Granted (in shares)				949,620
Performance-based restricted stock awards, M356 \| Shares vesting upon FDA approval
Additional disclosures
Vesting percentage		50.00%

Equity Financings (Details) - USD ($) $ in Thousands, shares in Millions	1 Months Ended		3 Months Ended		7 Months Ended	9 Months Ended
	Apr. 30, 2015	May. 31, 2014	Mar. 31, 2016	Mar. 31, 2015	Apr. 30, 2015	Dec. 31, 2015
Equity Financings
Aggregate sales proceeds from issue and sell of shares of common stock under sales agreement with Stifel				$ 33,665
Commission percentage paid	2.00%	2.00%
Aggregate stock sold pursuant to the sales agreement (in shares)				2.6	5.4
Aggregate receivable from sale of common stock under sales agreement with Stifel				$ 33,700	$ 73,500
ATM 2015
Equity Financings
Aggregate stock sold pursuant to the sales agreement (in shares)			0.0			0.5
Aggregate receivable from sale of common stock under sales agreement with Stifel						$ 9,300
Maximum
Equity Financings
Aggregate sales proceeds from issue and sell of shares of common stock under sales agreement with Stifel	$ 75,000	$ 75,000

Commitments and Contingencies (Details) $ in Millions		1 Months Ended		3 Months Ended
Commitments and Contingencies (Details) $ in Millions	Sep. 10, 2014 patent	Oct. 31, 2011 USD ($)	Sep. 30, 2011 item	Mar. 31, 2016 USD ($)
Legal Contingencies
Number of patents certifications that generic manufacturer's ANDA must include \| item			2
Orange Book-listed patents for 40 mg/ml Copaxone \| patent	2
Amount of security bond required to be posted by company and Sandoz in connection with the litigation		$ 100
Maximum amount of security bond for which the entity shall be responsible in the event of loss of case				$ 35

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