Exhibit 10.14
CERTAIN INFORMATION HAS BEEN EXCLUDED FROM THIS AGREEMENT (INDICATED BY “[***]”) BECAUSE SLATE MEDICINES, INC. HAS DETERMINED SUCH INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
LICENSE AGREEMENT
BETWEEN
DARTSBIO PHARMACEUTICALS LTD.
AND
SLATE MEDICINES, INC.
February 16, 2026
TABLE OF CONTENTS
| Page | ||||
| ARTICLE 1 DEFINITIONS |
1 | |||
| ARTICLE 2 LICENSE |
14 | |||
| ARTICLE 3 GOVERNANCE |
16 | |||
| ARTICLE 4 DEVELOPMENT |
18 | |||
| ARTICLE 5 REGULATORY MATTERS |
21 | |||
| ARTICLE 6 COMMERCIALIZATION |
24 | |||
| ARTICLE 7 MANUFACTURE AND SUPPLY |
25 | |||
| ARTICLE 8 COMPENSATION |
26 | |||
| ARTICLE 9 INTELLECTUAL PROPERTY MATTERS |
32 | |||
| ARTICLE 10 REPRESENTATIONS AND WARRANTIES; COVENANTS |
38 | |||
| ARTICLE 11 INDEMNIFICATION |
41 | |||
| ARTICLE 12 CONFIDENTIALITY |
43 | |||
| ARTICLE 13 TERM AND TERMINATION |
46 | |||
| ARTICLE 14 DISPUTE RESOLUTION |
49 | |||
| ARTICLE 15 MISCELLANEOUS |
50 | |||
| List of Schedules | ||
| Schedule 1.22 |
Dartsbio Licensed Patents, Dartsbio Product-Specific Licensed Patents | |
| Schedule 1.48 |
Licensed Compounds | |
| Schedule 2.4 |
Initial Technology Transfer Plan | |
| Schedule 4.7 |
Pre-Clinical Development Activities | |
| Schedule 7.2 |
Supply Terms | |
| Schedule 7.3 |
Manufacturing Technology Transfer | |
| Schedule 10.2(k) |
Existing Agreements | |
| Schedule 12.3(b) |
Press Release | |
| Schedule 13.7 |
Baseball Arbitration | |
LICENSE AGREEMENT
This LICENSE AGREEMENT (this “Agreement”) is entered into as of February 16, 2026 (the “Effective Date”) by and between DARTSBIO PHARMACEUTICALS LTD., a corporation organized and existing under the laws of People’s Republic of China and having a place of business at Third Floor, East Sanwei GMP Building 3, Cuihai Ave, Cuiheng New District Zongshan City, Guangdong Province, China (“Dartsbio”), and SLATE MEDICINES, INC., a corporation organized and existing under the laws of Delaware and having a place of business at c/o RA Capital Management, L.P., 200 Berkeley Street, 18th Floor, Boston, MA 02116 USA (“Slate Medicines”). Dartsbio and Slate Medicines are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Dartsbio is currently conducting research and development of an antibody program known as DS009;
WHEREAS, Slate Medicines is a biopharmaceutical company with experience in developing pharmaceutical products; and
WHEREAS, Slate Medicines desires to obtain from Dartsbio an exclusive license to Exploit the Licensed Products in the Slate Medicines Territory (with each capitalized term as respectively defined below), and Dartsbio is willing to grant such license to Slate Medicines, all under the terms and conditions hereof.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
1.1 “Acceptance” means (a) with respect to an IND for a Licensed Product filed with the FDA, the first to occur of either (i) a “may proceed” letter or similar communication from the FDA in writing in response to a dossier submitted to the FDA; or (ii) expiration of the thirty (30) day period (or any different time period pursuant to a change in applicable Laws after the Effective Date during which period the FDA may object to the IND for such Licensed Product) following the date of submission of an IND without receipt of notice from the FDA within such time period that the IND is subject to a clinical hold, or (b) with respect to a CTA for a Licensed Product filed with any Regulatory Authority outside the United States, (i) authorization to proceed equivalent to clause (a)(i) above or (ii) expiration of an objection period without receipt of notice of a hold or objection equivalent to clause (a)(ii) above, in each case by such Regulatory Authority outside the United States.
1.2 “Accounting Standards” means U.S. generally accepted accounting principles (“GAAP”) or, to the extent that Slate Medicines, its Affiliates or their respective Sublicensees adopts International Financial Reporting Standards (“IFRS”), then “Accounting Standards” means IFRS, in either case consistently applied.
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1.3 “Act” shall mean, as applicable, the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§301 et seq., and/or the Public Health Service Act, 42 U.S.C. §§262 et seq., as such may be amended from time to time.
1.4 “Adverse Risk” means any risk of [***] on the Development, procurement or maintenance of Regulatory Approval, Manufacture or Commercialization of Licensed Products.
1.5 “Affiliate” means, with respect to a particular Party, a Person that controls, is controlled by or is under common control with such Party at any time for so long as such Person controls, is controlled by or is under common control with such Party. For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such entity, whether by the ownership of fifty percent (50%) or more of the voting stock of such entity, or by contract or otherwise; provided, that, with respect to Slate Medicines, RA Capital Management, L.P. and any general partner, managing member, officer, director or trustee of any venture capital fund or investment fund now or hereafter existing that is controlled by RA Capital Management, L.P. or one or more general partners, managing members or investment advisers of, or shares the same management company or investment adviser with RA Capital Management, L.P. shall not be considered an Affiliate of Slate Medicines. For clarity, once a Person ceases to be an Affiliate of a Party, then, without any further action, such Person shall cease to have any rights, including license and sublicense rights, under this Agreement by reason of being an Affiliate of such Party.
1.6 “Anti-Corruption Laws” means laws, regulations, or orders prohibiting the provision of a financial or other advantage for a corrupt purpose or otherwise in connection with the improper performance of a relevant function, including without limitation, to the extent applicable, the Corruption of Foreign Public Officials Act (CFPOA), the US Foreign Corrupt Practices Act (FCPA), the UK Bribery Act 2010, and similar laws governing corruption and bribery, whether public, commercial or both, to the extent applicable.
1.7 “Biosimilar Product” means, with respect to a given Licensed Product in a given country, any product (including a “generic product,” “biogeneric,” “follow-on biologic,” “follow-on biological product,” “follow-on protein product,” “similar biological medicinal product,” or “biosimilar product”) that has been approved in such country through an application or submission for Regulatory Approval filed with the applicable Regulatory Authority where the application for such product claimed to be biosimilar or interchangeable to such Licensed Product, and that is sold in such country by any Third Party that (a) is not a Sublicensee of Slate Medicines or its Affiliates and (b) did not purchase such product in a chain of distribution that included any of Slate Medicines, its Affiliates or Sublicensees.
1.8 “Business Day” means a day other than Saturday, Sunday or any day that banks in Zhongshan, China; or New York City, New York, are required or permitted to be closed.
1.9 “Calendar Quarter” means each successive period of three (3) consecutive calendar months ending on March 31, June 30, September 30, or December 31, except the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day
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immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date, and the last Calendar Quarter shall end on the last day of the Term.
1.10 “Change of Control” means with respect to either Party: (a) the sale of all or substantially all of such Party’s assets or business relating to this Agreement (other than to an Affiliate of such Party); (b) a merger, reorganization or consolidation involving such Party in which the voting securities of such Party outstanding immediately prior thereto cease to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization or consolidation; or (c) a Person, or group of Persons, acting in concert acquire more than fifty percent (50%) of the voting equity securities or management control of such Party; provided that a Change of Control shall not include any transaction or series of transactions principally for bona fide equity financing purposes in which cash is received by a Party or any successor, indebtedness of a Party is cancelled or converted, or a combination thereof.
1.11 “Clinical Trial” means a Phase 1 Clinical Trial, a Phase 2 Clinical Trial, a Phase 3 Clinical Trial or a Phase 4 Clinical Trial.
1.12 “CMC Information” means Information related to the chemistry, manufacturing and controls of the Licensed Products, as specified by the FDA, EMA and other applicable Regulatory Authorities.
1.13 “Combination Product” means a product in which one or more therapeutically or prophylactically active ingredients that are not Licensed Products that are sold in combination with, in addition to, or in a bundle with, a Licensed Product. Such other active ingredient(s) are referred to as the “Other Product(s)”.
1.14 “Commercialization” means all activities undertaken before and after obtaining Regulatory Approvals relating specifically to the pre-launch, launch, promotion, detailing, medical education and medical liaison activities, marketing, pricing, reimbursement, sale, and distribution of Licensed Products, including strategic marketing, sales force detailing, advertising, market Licensed Product support, all customer support, Licensed Product distribution and invoicing and sales activities; provided, however, “Commercialization” shall exclude any activities relating to the Manufacture of Licensed Products. “Commercialize” and “Commercializing” shall have the correlative meanings.
1.15 “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by Slate Medicines to Exploit a Licensed Product, reasonable, good faith efforts to accomplish such objective as [***] would normally use to accomplish a similar objective under similar circumstances, for a similar biological or pharmaceutical product owned by it or to which it has rights, which product is at a similar stage in its development or product life and is of similar market potential, taking into account all relevant factors, including efficacy, safety, approved labeling, product profile, the competitiveness of alternative products in the marketplace, the patent and other proprietary position of the product, profitability (including pricing and reimbursement), and the likelihood of Regulatory Approval given the regulatory structure involved. Commercially Reasonable Efforts shall be determined on [***].
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1.16 “Confidential Information” of a Party means any and all Information of such Party or its Affiliates that is disclosed to the other Party or its Affiliates under this Agreement, whether in oral, written, graphic, or electronic form. In addition, all Information disclosed by a Party or its Affiliates pursuant to the Mutual Confidentiality Agreement by and between Slate Medicines and Dartsbio dated as of January 14, 2025 (the “Confidentiality Agreement”) shall be deemed to be Confidential Information of such Party disclosed hereunder; provided, however, that any use or disclosure of any such Information that is authorized under Article 12 shall not be restricted by, or be deemed a violation of, the Confidentiality Agreement. For clarity, during the Term, Dartsbio Licensed Know-How that is specifically related to a Licensed Compound shall be deemed Confidential Information of both Parties.
1.17 “Control” means, with respect to any material, Information, Patent or other intellectual property right, possession of the right, whether directly or indirectly, and whether by ownership, license, or otherwise, to grant a license, sublicense, or other right to or under, such material, Information, Patent, or intellectual property right without violating the terms of any existing agreement or other arrangement with any Third Party. Notwithstanding the foregoing, (a) in the event of a Change of Control of a Party, any material, Information, Patent or other intellectual property right Controlled by any Affiliate of such Party that was not an Affiliate of such Party immediately prior to such Change of Control transaction will not be Dartsbio Technology or Slate Medicines Technology except, in each case, to the extent any such material, Information, Patent or other intellectual property right (i) is also Controlled by such Party or its Affiliate existing immediately prior to such Change of Control transaction, or (ii) is generated or used by the applicable Party or such Affiliate in the conduct of activities in the Development, Manufacture and Commercialization of any Licensed Product after such Change of Control transaction; and (b) subject to Section 8.4(e), a Party and its Affiliates will not be deemed to “Control” any material, Information, Patent or other intellectual property right that is obtained by a Party from a Third Party after the Effective Date, unless such Party possesses the right to grant such license, sublicense, or other right to such material, Information, Patent or other intellectual property right to the other Party on the terms set forth herein without being obligated to pay any royalties or other consideration therefor, or the other Party agrees in advance of any grant of rights thereto to pay such royalties or other consideration arising as a result such Party’s or its Affiliate’s or Sublicensee’s use or practice of such material, Information, Patent or other intellectual property right under this Agreement.
1.18 “Cover” means, with respect to a Patent and a Licensed Product, that the Manufacture, use, offer for sale, sale or import of such Licensed Product by an unlicensed Third Party would fall within the scope of a Valid Claim in such Patent. “Covered” and “Covering” shall have the correlative meanings.
1.19 “CTA” means a Clinical Trial Application which provides comprehensive information about the investigational medicinal product(s) and planned trial, enabling Regulatory Authorities to assess the acceptability of conducting the applicable study.
1.20 “Dartsbio CGRP Bi/multi-specific Antibodies” means a bi/multi-specific antibody generated during the Term by or on behalf of Dartsbio directed to the Targets and calcitonin gene-related peptide (CGRP) or CGRP receptor.
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1.21 “Dartsbio Licensed Know-How” means any and all Information (including Data and Regulatory Materials) that (a)(i) is Controlled by Dartsbio or its Affiliates as of the Effective Date or (ii) becomes Controlled by Dartsbio or its Affiliates during the Term, and (b) is necessary or reasonably useful for the Exploitation of the Licensed Compounds or any Licensed Products in the Field in the Slate Medicines Territory, including Dartsbio’s interest in Joint Inventions satisfying the foregoing criteria. Notwithstanding anything to the contrary, Dartsbio Licensed Know-How does not include Information Controlled by Dartsbio or its Affiliates that is linker or payload for antibody-drug conjugates (ADCs), antibody-peptide conjugates (APCs), or the amino acid sequence of another binding domain other than those directed to the Targets for a multi-specific antibody, unless such Information has been provided by Dartsbio or its Affiliates to Slate Medicines or its Affiliates or incorporated into a Licensed Compound prior to the Effective Date.
1.22 “Dartsbio Licensed Patents” means any and all Patents that (a)(i) are Controlled by Dartsbio or its Affiliates as of the Effective Date or (ii) become Controlled by Dartsbio or its Affiliates during the Term, and (b) with the exception of Slate Medicines Patents and Slate Medicines’ interest in any Joint Patents, Cover the Licensed Compounds or any Licensed Products in the Field in the Slate Medicines Territory. Dartsbio Licensed Patents include the Patents listed in Schedule 1.22. Dartsbio shall update Schedule 1.22 from time to time to include additional patents, including patents issued from any listed application or claiming priority thereto or otherwise continuing therefrom. Notwithstanding anything to the contrary, Dartsbio Licensed Patents do not include Patents Controlled by Dartsbio or its Affiliates that claim a linker or payload for ADCs, APCs, or the amino acid sequence of another binding domain other than those directed to the Targets for a multi-specific antibody, unless such Patents claim Information that has been provided by Dartsbio or its Affiliates to Slate Medicines or its Affiliates or incorporated into a Licensed Compound prior to the Effective Date.
1.23 “Dartsbio Product-Specific Licensed Patents” means any Dartsbio Licensed Patents claiming the composition of matter of a Licensed Compound and/or any Licensed Product, formulations of a Licensed Compound and/or any Licensed Product, or the method of making or using, a Licensed Compound and/or any Licensed Product in the Field. The Parties acknowledge and agree that the Patents identified as Dartsbio Product-Specific Licensed Patents in Schedule 1.22 are the Dartsbio Product-Specific Licensed Patents as of the Effective Date.
1.24 “Dartsbio Technology” means the Dartsbio Licensed Know-How and Dartsbio Licensed Patents.
1.25 “Dartsbio Territory” means, collectively, mainland China, Taiwan, the Hong Kong Special Administrative Region, and the Macau Special Administrative Region.
1.26 “Data” means all data, including CMC Information, non-clinical data, preclinical data and clinical data, generated by or on behalf of a Party or its Affiliates or their respective Sublicensees (in the case of Slate Medicines) or licensees (in the case of Dartsbio) pursuant to activities conducted under this Agreement. For clarity, Data does not include any patentable Inventions.
1.27 “Development” means all activities conducted after the Effective Date relating to preclinical and clinical trials, toxicology testing, statistical analysis, publication and presentation
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of study results with respect to Licensed Products, and the reporting, preparation and submission of regulatory applications (including any CMC Information) for obtaining, registering and maintaining Regulatory Approval of Licensed Products; provided, however, “Development” shall exclude any activities relating to the Manufacture of Licensed Product. “Develop” and “Developing” shall have the correlative meanings.
1.28 “Drug Substance” means bulk drug substance that is represented for use in a drug that, when used in the Manufacturing of a drug, becomes an active pharmaceutical ingredient.
1.29 “EMA” means the European Medicines Agency or any successor entity.
1.30 “Exploit” or “Exploitation” means the making, having made, using, having used, selling, having sold, offering for sale or otherwise disposing of, the Licensed Products, including all discovery, research, Development (including the conduct of Clinical Trials), Manufacturing, registration, modification, enhancement, improvement, labeling, storage, formulation, exportation, importation, optimization, transportation, distribution, promotion, marketing and Commercialization activities related thereto.
1.31 “Europe” the United Kingdom, Switzerland, and members of the European Union.
1.32 “FDA” means the U.S. Food and Drug Administration or any successor entity.
1.33 “Field” means any and all uses.
1.34 “First Commercial Sale” means with respect to a country, the first sale of a Licensed Product in such country to a Third Party by or on behalf of Slate Medicines, its Affiliates or Sublicensees after Regulatory Approval (including any necessary pricing approval) has been obtained in such country.
1.35 “Fiscal Year” means Slate Medicines’ fiscal year that starts on January 1 and ends on December 31, save that the first Fiscal Year shall commence on the Effective Date and end on 31 December and the last Fiscal Year shall end on the date of termination or expiry of this Agreement.
1.36 “GCP” or “Good Clinical Practices” means the then-current standards, practices and procedures promulgated or endorsed by the FDA as set forth in the guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA and comparable regulatory standards, practices and procedures promulgated by the EMA or other Regulatory Authority applicable to the Slate Medicines Territory, as they may be updated from time to time, including applicable quality guidelines promulgated under the ICH.
1.37 “GLP” or “Good Laboratory Practices” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable regulatory standards promulgated by EMA or other Regulatory Authority applicable to the Slate Medicines Territory, as may be updated from time to time, including applicable quality guidelines promulgated under the ICH.
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1.38 “GMP” means (a) the good manufacturing practices required by the FDA and set forth in the FDCA or FDA regulations (including without limitation 21 CFR 210 and 211), policies, guidances or guidelines, or any applicable equivalent within a regulatory jurisdiction, including, without limitation, any applicable current good manufacturing practices requirements and pharmaceutical industry standards for the manufacture and testing of investigational pharmaceutical materials in force from time-to-time in the European Union (including, without limitation, Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice), the relevant national implementations of these rules and any relevant national and European Commission and Committee on Proprietary Medicinal Products guidance and, in particular, Annex 13 of the Guide to Good Manufacturing Practice entitled “Manufacture of investigational medicinal products”, as updated and amended from time-to-time, in each case in effect at any time during the term of this Agreement, for the manufacture, handling and testing of investigational pharmaceutical products; (b) the corresponding requirements of each applicable Regulatory Authority or other Governmental Authority; and (c) any other guidances, procedures, practices, arrangements, additions or clarifications, as the Parties may agree in writing from time-to-time.
1.39 “Governmental Authority” means any multi-national, national, federal, state, local, municipal, provincial or other governmental authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).
1.40 “ICH” means International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.
1.41 “IND” means an investigational new drug application submitted to the FDA pursuant to 21 C.F.R. Part 312, including any amendments or supplements thereto. References herein to IND will include, to the extent applicable, any foreign counterpart of the foregoing filed with a Regulatory Authority outside the U.S. for the investigation of a medicinal product in any other country or group of countries in conformance with the requirements of such Regulatory Authority.
1.42 “Indication” means a class of human disease or condition for which a separate MAA (including any extensions or supplements) is required to be filed with a Regulatory Authority. For clarity, if an MAA is approved for a Licensed Product in a particular Indication and patient population, a label expansion for such Licensed Product to include such Indication in a different patient population shall not be considered a separate Indication.
1.43 “Inflation Reduction Act” means the US, H.R. 5376 - 117th Congress (2021-2022): Inflation Reduction Act of 2022.
1.44 “Information” means any Data, results, technology, business or financial information or information of any type whatsoever, in any tangible or intangible form, including know-how, copyrights, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulae, software, algorithms, marketing reports, expertise, technology, test data (including pharmacological, biological, chemical, biochemical, clinical test data and data resulting from non-clinical studies), CMC Information, stability data and other study data and procedures.
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1.45 “Initiation” means, with respect to a Clinical Trial, [***] in such Clinical Trial. “Initiate” and “Initiating” shall have the correlative meanings.
1.46 “Inventions” means any inventions and/or discoveries, including processes, manufacture, composition of matter, Information, methods, assays, designs, protocols, and formulas, and improvements or modifications thereof, patentable or otherwise, that are generated, developed, conceived or reduced to practice (constructively or actually) by or on behalf of a Party or its Affiliates or their respective Sublicensees (in the case of Slate Medicines) or licensees (in the case of Dartsbio (but excluding Slate Medicines)) pursuant to or in connection with activities conducted under this Agreement, including all rights, title and interest in and to the intellectual property rights therein and thereto; provided, however, that Inventions shall exclude Data.
1.47 “Laws” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, municipal, city or other political subdivision, domestic or foreign.
1.48 “Licensed Compound” means an antibody generated by or on behalf of Dartsbio directed to the Targets before and during Term, including anti-idiotype antibodies, antibodies with incorporated half-life extended mutations, bispecific or multi-specific antibodies (but excluding Dartsbio CGRP Bi/multi-Specific Antibodies) that are directed to the Targets (and any other target), as well as any antibody directed to the Targets generated by or on behalf of Slate Medicines, its Affiliates or their respective Sublicensees during Term in accordance with this Agreement that is Covered by a Dartsbio Licensed Patent (including any Slate Medicines CGRP Bi/multi-Specific Antibodies). For clarity, “Licensed Compounds” include the lead antibody set forth on Schedule 1.48.
1.49 “Licensed Product” means any product in any form that contains a Licensed Compound.
1.50 “Manufacture” and “Manufacturing” mean activities directed to manufacturing, processing, filling, finishing, packaging, labeling, quality control, quality assurance testing and release, post-marketing validation testing, inventory control and management, storing and transporting any Licensed Product, including oversight and management of vendors therefor.
1.51 “Manufacturing Cost” means, with respect to a particular Drug Substance or drug product supplied by Dartsbio pursuant to Section 7.1 or Section 7.2: (a) if Dartsbio or its Affiliate Manufactures the applicable Drug Substance or drug product, the actual manufacturing cost of such Drug Substance or drug product (as determined in accordance with applicable Accounting Standards consistently applied with its other products); or (b) if a Third Party Manufactures such Drug Substance or drug product, the actual cost incurred by Dartsbio or its Affiliate for the Manufacture of such Drug Substance or drug product with such Third Party (as determined in accordance with applicable Accounting Standards consistently applied with its other products) without any additional mark-up; in each case of (a) and (b), excluding the external costs of insurance and transportation, import and export taxes and fees, and similar charges, for such Drug Substance or drug product.
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1.52 “Marketing Authorization Application” or “MAA” means a New Drug Application (“NDA”) or any other application to the appropriate Regulatory Authority for approval to market a pharmaceutical or biologic product (Biologics License Application, “BLA”, for the application in FDA), but excluding pricing approvals.
1.53 “Maximum Fair Price” means with respect to a given Licensed Product in a given year while such Licensed Product is a Selected Drug, the price negotiated pursuant to Section 1194 (and updated pursuant to Section 1195(b), as applicable) under the Inflation Reduction Act for such Licensed Product and such year.
1.54 “Medicare Net Price” means the final price of a drug after all discounts and rebates are applied, representing the total amount paid by Medicare.
1.55 “MHLW” means Japan’s Ministry of Health, Labour and Welfare, or any successor agency thereto.
1.56 “Net Sales” means [***].
1.57 “Patents” means (a) pending patent applications, issued patents, utility models and designs; (b) reissues, substitutions, confirmations, registrations, validations, re-examinations, additions, continuations, continued prosecution applications, continuations-in-part, or divisions of or to any of the foregoing; and (c) extensions, renewals or restorations of any of the foregoing by existing or future extension, renewal or restoration mechanisms, including supplementary protection certificate, patent term additions, patent term extensions or the equivalent thereof, and all foreign Patents issuing from any of the foregoing to the extent that are necessary and reasonably useful for practicing the licenses according to this Agreement.
1.58 “Person” means an individual, corporation, partnership, limited liability company, limited partnership, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, Governmental Authority or any other form of entity not specifically listed herein.
1.59 “Phase 1 Clinical Trial” means any human clinical trial of a Licensed Compound or Licensed Product conducted mainly to evaluate the safety of chemical or biologic agents or other types of interventions that would satisfy the requirements of 21 C.F.R. § 312.21(a) or its non-United States equivalents.
1.60 “Phase 2 Clinical Trial” means any human clinical trial of a Licensed Compound or Licensed Product conducted mainly to test the effectiveness of chemical or biologic agents or other types of interventions for purposes of identifying the appropriate dose for a Phase 3 Clinical Trial for a particular Indication or Indications that would satisfy the requirements of 21 CFR § 312.21(b) or its non-United States equivalents. A “Phase 2/3 Clinical Trial” shall be deemed to be a Phase 2 Clinical Trial with respect to the portion of that clinical trial that is regarded as its Phase 2 component, in accordance with the applicable protocol.
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1.61 “Phase 3 Clinical Trial” means any human clinical trial of a Licensed Compound or Licensed Product designed to: (i) establish that such Licensed Product is safe and efficacious for its intended use; (ii) define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (iii) support Regulatory Approval of such Licensed Compound or Licensed Product, that would satisfy the requirements of 21 CFR § 312.21(c) or its non-United States equivalents. A “Phase 2/3 Clinical Trial” shall be deemed to be a Phase 3 Clinical Trial with respect to the portion of that clinical trial that is regarded as its Phase 3 component, in accordance with the applicable protocol.
1.62 “Phase 4 Clinical Trial” means a human clinical trial of a Licensed Compound or Licensed Product that is (a) designed to satisfy a requirement of a Regulatory Authority in order to maintain a Regulatory Approval for such Licensed Compound or Licensed Product or (b) conducted after the first Regulatory Approval of such product in the same disease state for which the Licensed Compound or Licensed Product received Regulatory Approval.
1.63 “Product Specific Joint Patents” means any Patents that claim Joint Inventions that are specifically related to a Licensed Product.
1.64 “Profit Share” means any distribution of net profits from the sale of Licensed Products received by Slate Medicines or its Affiliates pursuant to a sublicense agreement under which Slate Medicines or its Affiliates funds a share of Development or Commercialization costs of Licensed Product(s) and receives a percentage of net profits with respect to the sales of Licensed Product(s) in one or more country(ies), such distribution being (a) agreed upon between the Slate Medicines and Sublicensee as consideration in lieu of or in addition to receiving earned royalties from the Sublicensee on Net Sales of such Licensed Product(s) in such country(ies) and (b) structured such that the percentage of such net profit share to Slate Medicines or its Affiliate does not exceed Slate Medicines’ or its Affiliate’s percentage share contribution of the Development or Commercialization costs of Licensed Products.
1.65 [***].
1.66 “Regulatory Approval” means any and all approvals (including marketing authorization approvals, supplements, amendments, pre- and post-approvals, and pricing and reimbursement approvals), licenses, registrations or authorizations of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, that are necessary for the Manufacture, distribution, marketing, importation, exportation, use or commercial sale of a Licensed Product in a given country or regulatory jurisdiction.
1.67 “Regulatory Authority” means, in a particular country or jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or jurisdiction.
1.68 “Regulatory Materials” means regulatory applications (including MAA), submissions, notifications, communications, correspondence, registrations, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, market, sell or otherwise Commercialize Licensed Products in a particular country or jurisdiction.
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1.69 “Representatives” means, as to any Person, such Person’s Affiliates and its and their successors, controlling Persons, directors, officers and employees.
1.70 “Selected Drug” means a drug that was selected for Medicare price negotiation and published by the Secretary of the US Department of Health and Human Services, in each case, under the Inflation Reduction Act.
1.71 “Selected Drug Publication Date” means, with respect to a Selected Drug, the date when the Secretary of the US Department of Health and Human Services, publishes that such Selected Drug is selected for price negotiation.
1.72 “Slate Medicines CGRP Bi/multi-specific Antibodies” means a bi/multi-specific antibody generated during the Term by or on behalf of Slate Medicines directed to the Targets and calcitonin gene-related peptide (CGRP) or CGRP receptor.
1.73 “Slate Medicines Patents” means any Patents that claim Slate Medicines Inventions.
1.74 “Slate Medicines Technology” means any Patents or Information Controlled by Slate Medicines or its Affiliates as of the Effective Date or during the Term that are necessary or useful for the Exploitation of a Licensed Product.
1.75 “Slate Medicines Territory” means worldwide, excluding the Dartsbio Territory.
1.76 [***].
1.77 “Sublicense” means any agreement under which Slate Medicines sublicenses to a Third Party any of the rights to Dartsbio Technology granted to Slate Medicines under Section 2.1(a), including, without limitation, any option for such rights, but excluding rights granted to subcontractors or Affiliates.
1.78 “Sublicensee” means a Third Party that has received a license or other right under the Dartsbio Technology in accordance with Section 2.1(c), but shall not include (i) any Third Party wholesaler or distributor engaged for the sale of Licensed Product (even if such wholesaler or distributor is granted a right or license to sell Licensed Product) provided that such wholesaler or distributor does not make any royalty, milestone, profit share or other payment to Slate Medicines or its Affiliate based on such wholesaler’s or distributor’s sale of Licensed Product; or (ii) any Third Party contract research organization or manufacturer providing services to Slate Medicines or its Affiliate (even if such contract research organization or manufacturer is granted a right or license to make Licensed Compound or Licensed Product). For clarity, the gross invoiced price for sale of Licensed Product to any wholesaler, distributor, contract research organization or manufacturer described above shall be included in Net Sales.
1.79 “Sublicensing Revenue” means any cash or equity consideration received by Slate Medicines or its Affiliate from a Sublicensee in consideration of the grant of a Sublicense
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or assignment or other conveyance of any of its rights to a Third Party (other than to a subcontractor) under the Dartsbio Technology, but excluding (a) royalties paid by a Sublicensee, (b) equity or debt investments in, or loan proceeds to, Slate Medicines (provided, that amounts paid by a Sublicensee in excess of fair market value for such investment shall be treated as Sublicensing Revenue), (c) payments by Sublicensees for payment or reimbursement of patent prosecution, defense, enforcement and maintenance and other related expenses, (d) payments by Sublicensees for bona fide research, development, manufacturing or commercialization activities (including, without limitation, payments for Slate Medicines’ internal employee costs) that occur after the effective date of the applicable sublicense agreement, (e) any Profit Share for any Licensed Product, and (f) payment received in connection with a transaction that constitutes a Change of Control, or an option to consummate a Change of Control.
1.80 “Target” means [***].
1.81 “Tax” means any form of tax or taxation, levy, duty, charge, social security charge, contribution or withholding of whatever nature, together with any related fine, penalty, surcharge or interest thereon imposed by, or payable to, a Governmental Authority.
1.82 “Third Party” means any Person other than a Party or an Affiliate of a Party.
1.83 “U.S. Dollar” means a U.S. dollar, and “US$” shall be interpreted accordingly.
1.84 “U.S.” or “USA” means the United States of America, including all possessions and territories thereof.
1.85 “Valid Claim” means a claim (including a process, product-by-process, method, use, or composition of matter claim) of (a) an issued and unexpired patent that has not (i) irretrievably lapsed or been revoked, dedicated to the public or disclaimed or (ii) been held invalid, unenforceable or not patentable by a court, governmental agency, national or regional patent office or other appropriate body that has competent jurisdiction, which holding, finding or decision is final and unappealable or unappealed within the time allowed for appeal, or (b) a pending patent application that has been prosecuted in good faith pending for no more than [***] since its priority date and has not been abandoned or finally disallowed without the possibility of appeal.
1.86 Additional Definitions: The following table identifies the location of definitions set forth in various Sections of this Agreement:
| Defined Terms |
Section | |
| Accused Party |
9.5 | |
| Agreement |
Preamble | |
| Alliance Manager |
3.1 | |
| BLA |
1.52 | |
| CGRP Collaboration |
2.5(c) | |
| Claims |
11.1 | |
| Confidentiality Agreement |
1.16 | |
| Dartsbio |
Preamble |
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| Defined Terms |
Section | |
| Dartsbio CGRP License |
2.5(b) | |
| Dartsbio Indemnitees |
11.2 | |
| Dartsbio Inventions |
9.1(b)(ii) | |
| Dartsbio VIP Antibody |
2.6 | |
| Development Milestone Event |
8.2 | |
| Development Milestone Payment |
8.2 | |
| Effective Date |
Preamble | |
| Enforcing Party |
9.4(c) | |
| Exclusive Negotiation Period |
2.5(c) | |
| Executive Officer |
14.1 | |
| Existing Agreements |
10.2(k) | |
| GAAP |
1.2 | |
| Headache Disorder |
2.6 | |
| IFRS |
1.2 | |
| Indemnified Party |
11.3 | |
| Indemnifying Party |
11.3 | |
| Infringement |
9.4(a) | |
| Infringement Action |
9.5 | |
| Joint Inventions |
9.1(b)(iv) | |
| Joint Steering Committee |
3.2(a) | |
| Losses |
11.1 | |
| Manufacturing Technology Transfer Agreement |
7.3 | |
| NDA |
1.52 | |
| Offer |
2.5(c) | |
| Option Period |
2.5(b) | |
| Party |
Preamble | |
| Pharmacovigilance Agreement |
5.5 | |
| Pre-Clinical Development Activities |
4.7 | |
| Product Materials |
4.5 | |
| Publication |
12.4(a) | |
| Remedial Action |
5.6 | |
| Reversion License |
13.7(g) | |
| ROFN |
2.6 | |
| ROFN Exercise Notice |
2.6(a) | |
| ROFN Exercise Notice Period |
2.6(b) | |
| ROFN Negotiation Period |
2.6(a) | |
| ROFN Notice |
2.6(a) | |
| ROFN Period |
2.6 | |
| Royalty Term |
8.4(b) |
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| Defined Terms |
Section | |
| Sales Milestone Event |
8.3 | |
| Sales Milestone Payment |
8.3 | |
| SEC |
12.3(c) | |
| SIAC |
14.2 | |
| Slate Medicines |
Preamble | |
| Slate Medicines Indemnitees |
11.1 | |
| Slate Medicines Inventions |
9.1(b)(iii) | |
| Step-In Rights |
9.2(e) | |
| Subject Change of Control |
8.1(c) | |
| Term |
13.1 | |
| Third Party License |
8.4(e) | |
| VAT |
8.10(c) | |
| Working Group |
3.5 |
ARTICLE 2
LICENSE
2.1 License to Slate Medicines.
(a) License Grant. Subject to the terms and conditions of this Agreement, Dartsbio hereby grants Slate Medicines an exclusive (even as to Dartsbio except as provided in Section 2.1(b) below) license, with the right to sublicense (solely as provided in Section 2.1(c)), under the Dartsbio Technology, to Exploit Licensed Products in the Field in the Slate Medicines Territory. Additionally, Dartsbio hereby grants Slate Medicines a non-exclusive license, with the right to sublicense (solely as provided in Section 2.1(c)), under the Dartsbio Technology, to conduct pre-clinical Development, Manufacture and have Manufactured, Licensed Products in the Field in the Dartsbio Territory for sale and use in the Slate Medicines Territory.
(b) Dartsbio Retained Rights. Notwithstanding the exclusive rights granted to Slate Medicines in Section 2.1(a), Dartsbio and its Affiliates shall retain the following:
(i) the right to practice the Dartsbio Technology within the scope of the license granted to Slate Medicines under Section 2.1(a) in order to perform, or have performed by a Third Party contractor, Dartsbio’s obligations under this Agreement, including the Pre-Clinical Development Activities;
(ii) the right to Manufacture or have Manufactured Licensed Products anywhere in the world for sale and use in the Dartsbio Territory; and
(iii) the right to practice and license the Dartsbio Technology outside the scope of the license granted to Slate Medicines under Section 2.1(a).
(c) Sublicense Rights. Slate Medicines shall have the right to grant sublicenses of the license granted in Section 2.1(a) without Dartsbio’s express prior written
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consent to its Affiliates and Third Parties (including subcontractors), but, in the case of a Sublicense to a Third Party (excluding subcontractors), upon prior written notice to Dartsbio. Slate Medicines shall be solely responsible for all of its sublicensees’ activities and any and all failures by its sublicensees to comply with the applicable terms of this Agreement, and no such sublicense shall relieve Slate Medicines of its obligations under this Agreement, except to the extent they are satisfactorily performed by any such Sublicensee. Each sublicense granted by Slate Medicines pursuant to this Section 2.1(c) will be subject and subordinate to this Agreement and will contain provisions consistent with the terms and conditions of this Agreement. Upon the execution of a sublicense agreement with a Third Party, Slate Medicines shall provide a copy of such sublicense agreement to Dartsbio within [***] after execution, which copy may be redacted to remove any confidential or commercially sensitive information not required for Dartsbio to confirm compliance with the terms of this Agreement. Additionally, Slate Medicines shall not grant a Sublicense to a Third Party under the Dartsbio Technology to Develop, Manufacture or Commercialize any Licensed Compound or Licensed Product in the Slate Medicines Territory unless Slate Medicines obtains a royalty-free, fully paid-up, non-exclusive license from such Third Party under any Information or Patents generated by such Third Party in connection with its Development, Manufacture or Commercialization of any Licensed Compound or Licensed Product in the Slate Medicines Territory such that Slate Medicines may grant a sublicense with respect thereto to Dartsbio for use in the Development, Manufacture and Commercialization of the Licensed Compound or Licensed Products in the Field in the Dartsbio Territory. Similarly, Dartsbio shall not grant a license to a Third Party (excluding rights granted to subcontractors or Affiliates) under the DartsBio Technology to Exploit any Licensed Compound or Licensed Product in the Dartsbio Territory unless Dartsbio obtains a royalty-free, fully paid-up, non-exclusive license from such Third Party under any Information or Patents generated by such Third Party in connection with its Exploitation of any Licensed Compound or Licensed Product in the Dartsbio Territory such that Dartsbio may grant a sublicense with respect thereto to Slate Medicines for use in the Development, Manufacture and Commercialization of the Licensed Compound or Licensed Products in the Field in the Slate Medicines Territory.
2.2 Grant-back License. Subject to the terms and conditions of this Agreement, Slate Medicines hereby grants Dartsbio (i) an exclusive, transferrable, royalty-free and fully paid-up license, with the right to sublicense through multiple tiers, under Slate Medicines Technology to Exploit Licensed Products in the Field in the Dartsbio Territory (provided, that Slate Medicines retains the right to Manufacture or have Manufactured Licensed Products in the Dartsbio Territory for sale and use in the Slate Medicines Territory); and (ii) a non-exclusive, transferrable, royalty-free and fully paid-up license, with the right to sublicense through multiple tiers, under the Slate Medicines Technology, to Manufacture and have Manufactured Licensed Products in the Slate Medicines Territory for sale and use in the Dartsbio Territory.
2.3 No Implied Licenses. Except as explicitly set forth in this Agreement, neither Party shall be deemed by estoppel or implication to have granted the other Party any license or other right to any intellectual property of such Party.
2.4 Transfer of Dartsbio Licensed Know-How. Dartsbio shall provide Slate Medicines with complete and accurate copies of the Dartsbio Licensed Know-How to the extent provided for in Schedule 2.4 and in accordance with the timeline specified therein. The JSC shall establish a reasonable process and schedule for the transfer of additional Dartsbio Licensed Know-
15
How as required for the filing of any regulatory filing in the Slate Medicines Territory and any other Dartsbio Licensed Know-How that subsequently comes into existence and becomes Controlled by Dartsbio or its Affiliates during the Term. Dartsbio shall reasonably cooperate with Slate Medicines in providing Slate Medicines with copies of such Dartsbio Licensed Know-How in accordance with the process and schedule agreed upon through the JSC.
2.5 [***]
ARTICLE 3
GOVERNANCE
3.1 Alliance Managers. Within [***] after the Effective Date, each Party shall appoint and notify the other Party of the identity of a representative having the appropriate qualifications, including a general understanding of pharmaceutical development, manufacturing, and commercialization issues, to act as its alliance manager under this Agreement (the “Alliance Manager”). The Alliance Managers shall serve as the primary contact points between the Parties for the purpose of providing each Party with information on the progress and results of each Party’s Development, Manufacturing, and Commercialization of Licensed Products. The Alliance Managers shall also be primarily responsible for facilitating the flow of information and otherwise promoting communication, coordination and collaboration between the Parties with respect to Licensed Products. Each Party may replace its Alliance Manager at any time upon written notice to the other Party.
3.2 Joint Steering Committees.
(a) Formation; Purpose. Within [***] after the Effective Date, the Parties shall establish a joint steering committee (the “Joint Steering Committee” or “JSC”) for the overall coordination and oversight of the Parties’ activities under this Agreement. The role of the JSC shall be:
(i) to review and discuss (but not approve (except as otherwise expressly provided for in Section 3.2(d))) each Party’s Development, Manufacture and Commercialization of Licensed Products in the Field in the Slate Medicines Territory and the Dartsbio Territory;
(ii) to coordinate the Commercialization of Licensed Products in the Slate Medicines Territory and Dartsbio Territory to ensure consistent global marketing of Licensed Products in the Field;
(iii) to review, discuss, and resolve any Adverse Risk brought to the JSC pursuant to Section 5.3;
(iv) to coordinate the overall Patent strategy for Licensed Products;
(v) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing.
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(b) Members. The JSC shall be comprised of an equal number of representatives from each Party. Each Party’s representatives shall be an officer, employee, consultant or agent of such Party or its Affiliate (provided, that any such consultant or agent is subject to obligations of confidentiality substantially similar to the provisions set forth in Section 12.1) having sufficient seniority within the applicable Party to make decisions arising within the scope of the JSC’s responsibilities. Each Party shall initially appoint [***] representatives to the JSC. The JSC may change its size from time to time by unanimous consent of its representatives, and each Party may replace its representatives at any time upon written notice to the other Party. Each Party shall appoint one (1) of its representatives on the JSC to act as the co-chairperson. The role of the co-chairpersons shall be to convene and preside at the JSC meetings and to ensure the circulation of meeting agendas at least [***] in advance of JSC meetings and the preparation of meeting minutes and any pre-read materials in accordance with Section 3.2(c), but the co-chairpersons shall have no additional powers or rights beyond those held by other JSC representatives. Employees or consultants of either Party that are not representatives of the Parties on the JSC may attend meetings of the JSC, provided that such attendees shall not vote or otherwise participate in the decision-making process of the JSC and are subject to obligations of confidentiality substantially similar to the provisions set forth in Section 12.1.
(c) Meetings. The JSC shall meet at least [***] per Fiscal Year during the Term, unless the Parties mutually agree in writing to a different frequency for such meetings. Either Party may also call a special JSC meeting (by videoconference or teleconference) by at least [***] prior written notice to the other Party in the event such Party reasonably believes that a significant matter must be addressed prior to the next regularly scheduled meeting, and such Party shall provide the JSC no later than [***] prior to the special meeting with materials reasonably adequate to enable an informed decision. The JSC may meet in person, by videoconference or by teleconference. All JSC meetings shall be conducted in English, and all communications, reports and records by and between the Parties under this Agreement shall be in English. The co-chairpersons shall alternate responsibility for preparing reasonably detailed written minutes of the JSC meetings that reflect, without limitation, all material decisions made at such meetings. The co-chairpersons (or their designees) shall send draft meeting minutes to each representative of the JSC for review and approval within [***] after the JSC meeting. Such minutes shall be deemed approved unless one or more JSC representatives object to the accuracy of such minutes within [***] of receipt.
(d) Decision Making. The JSC shall strive to seek consensus in its actions and decision making process and all decisions by the JSC shall be made by consensus, with each Party having collectively one (1) vote in all decisions. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC, the representatives of the Parties cannot reach an agreement as to such matter (to the extent that such matter requires the agreement of the Parties hereunder) within [***] after such matter was brought to the JSC for resolution or after such matter has been referred to the JSC, then, [***].
3.3 Limitation of JSC Authority. The JSC shall only have the powers expressly assigned to it in this Article 3 and elsewhere in this Agreement and shall not have the authority to: (a) modify or amend the terms and conditions of this Agreement; (b) waive or determine either Party’s compliance with the terms and conditions of under this Agreement; or (c) decide any issue in a manner that would conflict with the express terms and conditions of this Agreement.
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3.4 Discontinuation of the JSC. The activities to be performed by the JSC shall solely relate to governance under this Agreement, and are not intended to be or involve the delivery of services. The JSC shall continue to exist unless the Parties mutually agree to disband the JSC. Thereafter, the JSC shall have no further obligations under this Agreement and each Party shall designate a contact person for the exchange of information relevant to activities that would have been performed by the JSC under this Agreement and decisions of the JSC shall be decisions as between the Parties, subject to the other terms and conditions of this Agreement.
3.5 Working Groups. From time to time, the JSC may establish and delegate duties of the JSC to sub-committees or directed teams (each, a “Working Group”) on an “as-needed” basis to oversee particular projects or activities; provided that in any case neither Party shall be required by the Working Group to assume any responsibility, financial or otherwise, beyond those agreed to in writing by such Party, in particular pursuant to each Party’s respective obligations under this Agreement. Each such Working Group shall be constituted and shall operate as the JSC determines; provided that each Working Group shall have equal representation from each Party, unless otherwise mutually agreed. Working Groups may be established on an ad hoc basis for purposes of a specific project or on such other basis as the JSC may determine. Each Working Group and its activities shall be subject to the oversight, review and approval of, and shall report to, the JSC. In no event shall the authority of the Working Group exceed that of the JSC. All decisions of a Working Group shall be by consensus. Any disagreement between the members of a Working Group shall be referred to the JSC for resolution.
ARTICLE 4
DEVELOPMENT
4.1 Overview; Diligence. Subject to the terms and conditions of this Agreement (including the diligence obligations set forth below), Slate Medicines shall be solely responsible for the Development of Licensed Products in the Field in the Slate Medicines Territory, at its own cost and expense (except as otherwise expressly set forth herein), including all non-clinical and clinical studies and collection of CMC Information, as necessary to obtain Regulatory Approval for Licensed Products in any country in the Slate Medicines Territory. Slate Medicines shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for at least one (1) Licensed Product in the Field in the United States, provided that Slate Medicines shall not be liable for any delays in any Development activities that are caused by any force majeure event as specified in Section 15.2 or Dartsbio’s failure to provide to Slate Medicines Product Materials that are necessary for the performance of such Development activities. For clarity, Slate Medicines shall have sole discretion whether to Develop Licensed Products in the Field in all other jurisdictions in the Slate Medicines Territory (including Germany, France, Italy, Spain, the United Kingdom, and Japan). Slate Medicines shall be solely responsible for all decisions regarding the day-to-day conduct of Development in the Field within the Slate Medicines Territory. Activities by Slate Medicines’ Affiliates and Sublicensees will be considered as Slate Medicines’ activities under this Agreement for purposes of determining whether Slate Medicines has complied with any obligation to use Commercially Reasonable Efforts. Dartsbio shall provide, through the JSC, regular, written updates on its planned development of Licensed Compounds and Licensed Products in the Dartsbio Territory, including by providing an annual development plan at the final JSC meeting for a given Calendar Year which sets forth all of Dartsbio’s development activities for the following Calendar Year.
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4.2 Cooperation. Dartsbio shall provide such technical assistance and cooperation to Slate Medicines as Slate Medicines may reasonably request as necessary or reasonably useful for Slate Medicines to Develop or Commercialize Licensed Products in the Field in the Slate Medicines Territory; provided, that Slate Medicines shall reimburse Dartsbio for any internal employee costs at the rate of [***] per hour and out-of-pocket costs incurred by Dartsbio in connection with such assistance; provided, further, that all activities for the purpose of enabling IND or CTA Acceptance and technology transfer under Schedule 2.4 will be provided at no cost to Slate Medicines, and a total of [***] internal employee hours incurred by Dartsbio in connection with the assistance under this Section 4.2 to the extent unrelated to IND or CTA Acceptance and the technology transfer under Schedule 2.4, and Section 7.3, will be free of charge.
4.3 Development Records. Each Party shall maintain complete, current and accurate records of all activities (and all Data and other Information resulting from such activities) conducted with respect to Licensed Products by such Party, its Affiliates and their respective Sublicensees (in the case of Slate Medicines) and licensees (in the case of Dartsbio). Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory and patent purposes. Each Party shall document all non-clinical studies and Clinical Trials for Licensed Products in formal written study records according to applicable Laws, including applicable national and international guidelines such as ICH, GCP and GLP, and shall provide the other Party English translations thereof (to the extent prepared and originated in a language other than English), provided that the cost of providing such records in languages other than required in the party’s own territory is compensated. Each Party shall have the right to review and copy such records at reasonable times and to obtain access to the original to the extent necessary or useful for regulatory or patent purposes in accordance with this Agreement.
4.4 Development Reports. Each Party shall keep the other Party reasonably informed as to the progress of such Party’s, its Affiliates’ and their respective (Sub)licensees’ Development activities (including, in the case of Dartsbio, prompt reporting of available clinical Data (in English, provided that the cost of providing such records in languages other than required in the party’s own territory is compensated). Without limiting the foregoing, at each regularly scheduled JSC meeting, each Party shall provide the other Party with a reasonably detailed written report summarizing its Development activities performed since the last JSC meeting. In addition, within [***] after the end of each Fiscal Year, each Party shall provide the other Party with a detailed written annual report regarding the progress of its Development activities.
4.5 Data Exchange. In addition to Dartsbio’s obligation with respect to the transfer of Dartsbio Licensed Know-How set forth under Section 2.4 and each Party’s adverse event and safety Data reporting obligations pursuant to Section 5.5, but subject to any applicable Laws and the remainder of this Section 4.5, each Party shall, at its sole cost and expense, promptly provide the other Party with copies of any Data and Regulatory Materials related to the Licensed Compound or Licensed Products generated by or on behalf of by such Party, its Affiliates and their respective Sublicensees (in the case of Slate Medicines) and licensees (in the case of Dartsbio) in the performance of Development activities hereunder that would be reasonably necessary for the
19
Exploitation of Licensed Compound or Licensed Products in the Field (the “Product Materials”). To the extent any such Product Materials are in a language other than English, Dartsbio shall provide Slate Medicines with an English translation thereof. The JSC may establish reasonable policies to effectuate the exchange of additional Product Materials between the Parties. Notwithstanding this Section 4.5, a disclosing Party shall have no obligation to provide any Product Materials to the other Party to the extent that any applicable Law prohibits the disclosing Party from providing such Product Materials to receiving Party, provided that the disclosing Party shall use commercially reasonable efforts to obtain all necessary consents, approvals, licenses or exceptions and complete any necessary actions (including entering into any additional documents or agreements where required by applicable Law) to allow the receiving Party’s access to and use of such Product Materials and each Party shall provide all reasonably necessary assistance to the other Party to enable such disclosure. To the extent applicable, each Party will, and will cause its Affiliates, licensees, sublicensees or subcontractors to, to the extent required by applicable Law, fulfill the conditions necessary or required for cross-border transfer of such Product Materials (including personal data) from such Party to the other Party (including executing applicable standard contractual clauses and completion of any necessary filing or review with the competent Governmental Authority) stipulated under applicable Law (including the Personal Information Protection Law of the People’s Republic of China), which shall specify and be designed to permit the additional collection and data uses by the other Party as reasonably contemplated under this Agreement. During the Term, each Party shall obtain all necessary consents from participants or individuals involved in any Clinical Trial conducted by such Party, its Affiliates, licensees, sublicensees or subcontractors for the transfer of any Product Materials arising from such Clinical Trials to the other Party or its designee in compliance with applicable Law, and will take all other reasonable steps to ensure that such Product Materials collected by it can be transferred to and further used by the other Party as contemplated by this Agreement.
4.6 Subcontractors. Slate Medicines shall have the right to engage subcontractors to conduct any activities necessary for Development or Manufacturing of Licensed Products, including but not limited to non-clinical studies, Clinical Trials, CMC activities, and regulatory services for Licensed Products, under this Agreement. Slate Medicines shall remain responsible for any obligations that have been subcontracted to its subcontractors and shall be responsible for the performance thereof.
4.7 Pre-Clinical Development Activities. Notwithstanding Section 4.1, Dartsbio shall, either by itself or through its Affiliate or subcontractors, conduct certain specified pre-clinical development activities set forth in Schedule 4.7 (the “Pre-Clinical Development Activities”) at its own expense. The Pre-Clinical Development Activities shall be conducted in accordance with industry standards, written instructions from Slate Medicines, and applicable Laws, including applicable national and international guidelines such as ICH, GCP and GLP. Dartsbio shall promptly provide the JSC with an update of such activities and will provide Data and Information generated in connection with such Pre-Clinical Development Activities in accordance with Sections 4.4 and 4.5.
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ARTICLE 5
REGULATORY MATTERS
5.1 Regulatory Responsibilities.
(a) Subject to the terms and conditions of this Agreement, Slate Medicines will be responsible, at its sole cost and expense, for the conduct of all regulatory activities required to obtain and maintain Regulatory Approval of Licensed Products in the Field in the Slate Medicines Territory, including the preparation and submission of all Regulatory Materials and all communications and interactions with Regulatory Authorities, as necessary to obtain Regulatory Approval for Licensed Products in the Field in any country in the Slate Medicines Territory. Slate Medicines shall be responsible for filing each CTA and MAA in the Field in the Slate Medicines Territory for each Licensed Product.
(b) Slate Medicines shall prepare and submit all Regulatory Materials for the Licensed Product in the Field in the Slate Medicines Territory. Slate Medicines shall timely notify Dartsbio of all material regulatory communications that are related to the Licensed Product in the U.S. and give Dartsbio a reasonable opportunity to review and comment. Dartsbio shall prepare and submit all Regulatory Materials for the Licensed Product in the Field in the Dartsbio Territory. Dartsbio shall timely notify Slate Medicines of all material regulatory communications that are related to the Licensed Product in the Dartsbio Territory and give Slate Medicines a reasonable opportunity to review and comment. Each Party shall provide to the other Party copies of the final submitted version of each material Regulatory Material and each granted Regulatory Approval in its respective territory.
(c) Each Party shall provide all reasonable assistance and cooperation to the other Party as the other Party may reasonably request, at the other Party’s sole cost and expense, during the Term of this Agreement, with respect to the satisfaction of its obligations under Section 5.1(a) or preparation of Regulatory Materials for the Licensed Product in the Dartsbio Territory, including (i) in connection with the preparation of Regulatory Materials, (ii) (A) making available competent personnel to attend regulatory meetings or join such meetings by teleconference and (B) providing documentation within its possession and control, in each case as requested by Regulatory Authorities at the requesting Party’s cost, and (iii) providing the requesting Party with additional Regulatory Materials as requested by Regulatory Authorities in the requesting Party’s territory within a reasonable timeframe commensurate with the volume of the requesting Party’s reasonable request. Dartsbio shall keep Slate Medicines informed of regulatory developments related to the Licensed Product(s) in the Dartsbio Territory via the JSC. Slate Medicines shall keep Dartsbio informed of regulatory developments related to the Licensed Product(s) in the Slate Medicines Territory via the JSC.
5.2 Right of Reference to Regulatory Materials. Each Party (including its licensee(s), if any) hereby grants to the other party the right to utilize all data generated during the research, Development and Commercialization of the Licensed Product in the Party’s Territory and (ii) the right to use any dossiers prepared, and reference any applications for Regulatory Approvals filed, in the Party’s Territory, in each case of (i) and (ii), to the extent necessary or reasonably useful for the other Party’s filings for regulatory approvals in relation to the Licensed Product in the other Party’s Territory in the Field and for the Manufacture, Development and Commercialization thereof. Each Party shall support the other Party, as reasonably requested by the other Party and at the other Party’s expense, in obtaining Regulatory Approvals in the other Party’s territory, including providing necessary documents or other materials required by applicable Laws to obtain Regulatory Approval in such territory, all in accordance with the terms and conditions of this Agreement.
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5.3 No Harmful Actions. If either Party believes that the other Party is taking or intends to take any action with respect to any Licensed Product that could reasonably be expected to have an Adverse Risk, whether in the Dartsbio Territory or in the Slate Medicines Territory, such Party may bring the matter to the attention of the JSC and the Parties shall discuss in good faith to promptly resolve such concern.
5.4 Notification of Threatened Action. Each Party shall immediately (but in any event no later than [***]) notify the other Party (including by providing notice to the other Party’s Alliance Manager) of any information it receives regarding any threatened or pending action, inspection or communication by or from any Third Party, including without limitation a Regulatory Authority, which may affect the Development, Manufacture, Commercialization or regulatory status of any Licensed Product in the other Party’s territory. Upon receipt of such information, the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action.
5.5 Adverse Event Reporting and Safety Data Exchange. During the Term, the Parties agree to comply with any and all applicable Laws then applicable to the Licensed Product safety data collection and reporting. No later than [***] before the Initiation of the first Clinical Trial with respect to the Development of any Licensed Product in the Slate Medicines Territory, the Parties shall define and finalize the actions that the Parties shall employ with respect to such Licensed Product to protect patients and promote their well-being in a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”) for the Development of the Licensed Product globally. Further, no later than [***] before the anticipated launch date of any Licensed Product in the Slate Medicines Territory, the Parties shall enter into a separate Pharmacovigilance Agreement for the Commercialization of the Licensed Product. Each of the Pharmacovigilance Agreements shall include mutually acceptable guidelines and procedures for the receipt, investigation, recording, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of the Licensed Product, and other routine pharmacovigilance reporting requirements. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under applicable Laws. Furthermore, such agreed procedure shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory reporting requirements, in which case the local reporting requirements shall prevail. The Pharmacovigilance Agreement shall provide for an adverse event database for the Licensed Products in the Field in the Dartsbio Territory to be maintained by Dartsbio at Dartsbio’s expense, and a global safety database for the Licensed Products to be maintained by Slate Medicines at Slate Medicines’ expense. As between the Parties, Dartsbio shall be responsible for preparing all adverse event reports and responses to safety issues and requests of Regulatory Authorities relating to Licensed Products in the Field in the Dartsbio Territory, and Slate Medicines shall be responsible for filing such reports and responses with Regulatory Authorities in the Field in the Slate Medicines Territory. As between the Parties, Dartsbio shall also be responsible for reporting any quality complaints, adverse events and safety data related to Licensed Products in the Field in the Dartsbio Territory to Slate Medicines for inclusion in the global safety database. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement and to cause its Affiliates and Sublicensees and licensees to comply with such obligations.
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5.6 Remedial Actions. Each Party will notify the other Party immediately (but in any event no later than [***]), and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product may be subject to any recall, corrective action or other similar regulatory action taken by virtue of applicable Laws (a “Remedial Action”). The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. Each Party shall, and shall ensure that its Affiliates and Sublicensees and licensees will, maintain adequate records to permit the Parties to trace the packaging, labeling, distribution, sale and use (to the extent possible) of the Licensed Product in the Slate Medicines Territory and the Dartsbio Territory. Slate Medicines shall have sole discretion with respect to any matters relating to any Remedial Action in the Slate Medicines Territory in the Field, including the decision to commence such Remedial Action and the control over such Remedial Action in its territory, at its cost and expense. Dartsbio shall have sole discretion with respect to any matters relating to any Remedial Action in the Dartsbio Territory, including the decision to commence such Remedial Action and the control over such Remedial Action in its territory, at its cost and expense; provided, however, if either Party determines in good faith that any Remedial Action with respect to any Licensed Product in the other Party’s territory should be commenced or is required by applicable Laws or Regulatory Authority, such other Party shall discuss such Remedial Action with such Party.
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ARTICLE 6
COMMERCIALIZATION
6.1 Overview; Diligence. Subject to the terms and conditions of this Agreement (including the diligence obligations set forth below), Slate Medicines shall have the sole right and responsibility for and have operational control over all aspects of the Commercialization of Licensed Products in the Field in the Slate Medicines Territory, including: (a) developing and executing a commercial launch and pre-launch plan, (b) negotiating with applicable Governmental Authorities regarding the price and reimbursement status of Licensed Products; (c) marketing, advertising and promotion; (d) booking sales and distribution and performance of related services; (e) handling all aspects of order processing, invoicing and collection, inventory and receivables; (f) providing customer support, including handling medical queries, and performing other related functions; and (g) conforming its practices and procedures to applicable Laws relating to the marketing, detailing and promotion of Licensed Products in the Field in the Slate Medicines Territory. Slate Medicines shall bear all of the costs and expenses incurred in connection with such Commercialization activities. Slate Medicines shall use Commercially Reasonable Efforts to Commercialize each Licensed Product in the United States.
6.2 Commercialization Reporting. Slate Medicines shall, on each anniversary of the first commercial launch of the Licensed Product, provide Dartsbio with a written report summarizing in reasonable detail its major Commercialization activities conducted during the prior Fiscal Year. All information and reports provided to Dartsbio pursuant to this Section 6.2 shall be treated as Confidential Information of Slate Medicines hereunder.
6.3 No Diversion. Each Party hereby covenants and agrees that it shall not, and shall ensure that its Affiliates and Sublicensees or licensees, will not, directly or indirectly, promote, market, distribute, import, sell or have sold the Licensed Products, including via internet or mail order, in the other Party’s territory. With respect to any country in the other Party’s territory, a Party shall not, and shall ensure that its Affiliates and their respective Sublicensees (in the case of Slate Medicines) or licensees, will not: (a) establish or maintain any branch, warehouse or distribution facility for Licensed Products in such countries for distribution of Licensed Products in such countries, (b) knowingly engage in any advertising or promotional activities relating to Licensed Products that are directed primarily to customers or other purchaser or users of Licensed Products located in such countries, (c) actively solicit orders for Licensed Products from any prospective purchaser located in such countries, or (d) knowingly sell or distribute Licensed Products to any person in such Party’s territory who intends to sell or has in the past sold Licensed Products in such countries. If either Party receives any order for any Licensed Product from a prospective purchaser reasonably believed to be located in a country in the other Party’s territory, such Party shall promptly refer that order to the other Party and such Party shall not accept any such orders. Each Party shall not deliver or tender (or cause to be delivered or tendered) Licensed Products into a country in the other Party’s territory. Each Party shall not, and shall ensure that its Affiliates and their respective Sublicensees (in the case of Slate Medicines) or licensees, will not, knowingly restrict or impede in any manner the other Party’s exercise of its retained exclusive rights in the other Party’s territory.
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ARTICLE 7
MANUFACTURE AND SUPPLY
7.1 Drug Substance Supply. Slate Medicines will be solely responsible for the Manufacture of Drug Substance of Licensed Compounds and Licensed Products in the Field for use in the Slate Medicines Territory. Notwithstanding the foregoing, Dartsbio shall, until Slate Medicines’ assumption of Manufacturing of Drug Substance of Licensed Compounds and Licensed Products pursuant to Section 7.3, supply to Slate Medicines its requirements of Drug Substance of Licensed Compound and Licensed Product for use in pre-clinical Development and up to Phase I Clinical Trials. Slate Medicines shall pay to Dartsbio for such supply at Dartsbio’s Manufacturing Cost, plus [***]; provided, that a mutually agreed amount (up to the first [***]) of Drug Substance shall be supplied free of charge.
7.2 Drug Product Supply. Slate Medicines will be solely responsible for the Manufacture of drug product of Licensed Compounds and Licensed Products in the Field for use in the Slate Medicines Territory. Notwithstanding the foregoing, Dartsbio shall, until Slate Medicines’ assumption of Manufacturing of drug product of Licensed Compounds and Licensed Products pursuant to Section 7.3, supply to Slate Medicines its requirements of drug product of Licensed Compound and Licensed Product for use in pre-clinical Development and up to Phase I Clinical Trials. Slate Medicines shall pay to Dartsbio for such supply at Dartsbio’s Manufacturing Cost, plus [***]; provided, that a mutually agreed amount (up to the first [***]) of drug product shall be supplied free of charge. The supply by Dartsbio of Drug Substance and drug product for such Licensed Compounds and Licensed Products shall be governed by the terms and conditions set forth in Schedule 7.2; which Schedule 7.2 shall be finalized within [***] after the Effective Date.
7.3 Manufacturing Technology Transfer. Within [***] after the written request of Slate Medicines, Dartsbio will transfer to Slate Medicines at no additional mark-up (for clarity, Slate Medicines shall bear the relevant transfer costs, including freight costs, customs (if any), etc.) the quantities of Licensed Product (both in Drug Substance and drug product), cell lines, cell banks, cell culture medium formulation, reagents, placebos, Clinical Trial samples and other samples and raw materials, in each case as set forth on Schedule 7.3. Additionally, within [***] after written request of Slate Medicines, the Parties shall negotiate in good faith and enter into a manufacturing technology transfer agreement for Drug Substance and drug product (the “Manufacturing Technology Transfer Agreement”). For clarity, such request may be for a manufacturing transfer of Drug Substance, drug product or both. Under such Manufacturing Technology Transfer Agreement, Dartsbio shall transfer or have transferred to Slate Medicines such documents and information, and provide such technical assistance and support, necessary or reasonably useful for Slate Medicines to Manufacture, or have Manufactured by a Third Party contractor engaged by Slate Medicines, the Drug Substance or drug product, as applicable, of the Licensed Product. Subject to the last sentence of Section 4.2, Slate Medicines shall pay any reasonable external costs incurred by Dartsbio and any internal employee costs at the rate of [***] per hour in connection with providing such information or assistance pursuant to this Section 7.3, to the extent such activities are not set forth in the Schedule 7.3. Upon Slate Medicines’ reasonable request, Dartsbio shall facilitate, cooperate with and assist Slate Medicines in entering into its own agreement with respect to the cell line to be used in the Manufacture of Licensed Product by or on behaf of Slate Medicines, its Affiliates or Sublicensees, and, as between the Partis, Slate Medicines shall be solely responsible for the payments and obligations thereunder, and such agreement shall not be deemed a Third Party License.
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7.4 Distribution. Slate Medicines will be solely responsible for the distribution of Licensed Products in the Field in the Slate Medicines Territory.
ARTICLE 8
COMPENSATION
8.1 Upfront Payment; Technology Transfer Milestone; Change of Control Payment.
(a) Upfront Payment. Within twenty (20) Business Days after the Effective Date, Slate Medicines shall pay to Dartsbio by wire transfer to a bank account designated in writing by Dartsbio a one-time, non-refundable, non-creditable upfront payment of [***] as partial consideration for the rights granted by Dartsbio to Slate Medicines under this Agreement. Additionally, within (60) Business Days after the Effective Date, Slate Medicines shall pay to Dartsbio by wire transfer to a bank account designated in writing by Dartsbio an additional one-time, non-refundable, non-creditable upfront payment of [***] as partial consideration for the rights granted by Dartsbio to Slate Medicines under this Agreement.
(b) Service Fee. Within [***] after the completion of the technology transfer set forth in Schedule 2.4 and IND/CTA Acceptance, Slate Medicines shall pay Dartsbio a one-time, non-refundable, non-creditable payment of Five Million U.S. Dollars (US$5,000,000) by wire transfer to a bank account designated in writing by Dartsbio. Such payment shall constitute partial consideration for the rights granted by Dartsbio to Slate Medicines under this Agreement, as a reimubursement for Dartsbio’s services of the manufacture of Drug Substance and drug product, establishing and completing the assays required for Slate Medicines to initiate a Phase 1 Clinical Trial in the Slate Medicines Territory, and conducting additional safety and PK studies proposed by Slate Medicines. Dartsbio shall not request or claim any additional compensation or consideration in respect of the R&D activities set forth in Schedule 2.4 and Schedule 7.3. Notwithstanding anything to the contrary, for the purpose of this Section 8.1(b), approval by the Human Research Ethics Committee shall constitute IND/CTA Acceptance in Australia.
(c) [***]
8.2 Development Milestone Payments. On or before [***] after Slate Medicines or any of its Affiliates or Sublicensees first achieves each milestone event specified below (each, a “Development Milestone Event”), Slate Medicines shall notify Dartsbio in writing of that fact. Dartsbio shall submit an invoice to Slate Medicines for each payment after the corresponding Development Milestone Event is achieved by the first Licensed Product by Slate Medicines or any of its Affiliates or Sublicensees (each, a “Development Milestone Payment”). Slate Medicines will pay any Development Milestone Payments that are payable within [***] after receipt of such invoice.
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| Development Milestone Event | Development Milestone Payment | |||
| [***] | [***] | [***] | ||
| [***] | [***] | [***] | ||
| [***] | [***] | [***] | ||
| [***] | [***] | [***] | ||
| [***] | [***] | [***] | ||
| [***] | [***] | [***] | ||
| [***] | [***] | [***] | ||
| [***] | [***] |
| | As evidenced by [***]. |
Each Development Milestone Payment set forth above shall be payable only once with respect to a Licensed Product, regardless of the number of times the applicable Development Milestone Event is achieved by one or more Licensed Products. Under no circumstances shall Slate Medicines be obligated to pay Dartsbio more than Fifty-Four Million Five Hundred Thousand U.S. Dollars (US$54,500,000) pursuant to this Section 8.2. [***].
For the purpose of this Section 8.2, references to the BLA Approval or MAA Approval shall include [***].
8.3 Commercial Milestone Payments. Slate Medicines shall make the following milestone payments (each, a “Sales Milestone Payment”) to Dartsbio within [***] after the end of the Fiscal Year in which the annual Net Sales of all Licensed Products in the Field in the Slate Medicines Territory by Slate Medicines and its Affiliates and Sublicensees for such Licensed Products first reach each of the amounts specified below in a Fiscal Year (each, a “Sales Milestone Event”); provided, that the Sales Milestone Payments for Sales Milestone Events #1, #2, and #3 shall be payable within [***] after the occurrence of the applicable Sales Milestone Event. Each such Sales Milestone Payment shall be payable one time only. For clarity, the Sales Milestone Payments shall be additive such that if more than one of the Sales Milestone Events are met for the first time in the same Fiscal Year, Slate Medicines shall pay all Sales Milestone Payments corresponding to such achieved Sales Milestone Events to Dartsbio for that Fiscal Year. For clarity, each of the following Sales Milestone Payments shall be payable only once regardless of the number of times such Sales Milestone Event is achieved with respect to Licensed Products. Under no circumstances shall Slate Medicines be obligated to pay Dartsbio more than Nine Hundred Eighty-Eight Million Dollars ($988,000,000) pursuant to this Section 8.3 for Licensed Products.
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| Commercial Milestone Event | Sales Milestone Payment | |||
| [***] | [***] | [***] | ||
| [***] | [***] | [***] | ||
| [***] | [***] | [***] | ||
| [***] | [***] | [***] | ||
| [***] | [***] | [***] | ||
| [***] | [***] | [***] | ||
| [***] | [***] | [***] |
8.4 Royalties on Net Sales.
(a) Royalty Rates. Subject to the terms and conditions of this Section 8.4, Slate Medicines shall pay to Dartsbio royalties on aggregate annual Net Sales of all Licensed Products in the Slate Medicines Territory during the applicable Royalty Term, as calculated by multiplying the applicable royalty rate below by the corresponding amount of incremental Net Sales of all Licensed Products in the Slate Medicines Territory in each Fiscal Year.
| Annual Net Sales of Licensed Products
in the Slate Medicines |
Royalty Rate | |
| [***] |
[***] | |
| [***] |
[***] | |
| [***] |
[***] |
(b) Royalty Term. Royalties payable under Section 8.4(a) shall be paid by Slate Medicines (on a Licensed Product-by-Licensed Product and country-by-country basis) from the period beginning on the date of the First Commercial Sale of each Licensed Product in a country in the Slate Medicines Territory and continuing until the later of: (i) ten (10) years from the date of First Commercial Sale of such Licensed Product in such country, and (ii) expiration of the last Valid Claim of a Dartsbio Product-Specific Licensed Patent Covering such Licensed Product in such country (the “Royalty Term”). Upon expiration of the applicable Royalty Term for a Licensed Product in a country, sales of such Licensed Product in such country shall no longer be included in the calculation of Net Sales for the purposes of determining the applicable royalty rate for Net Sales of Licensed Products.
(c) Know-How Reduction. On a Licensed Product-by-Licensed Product, country-by-country and Calendar Quarter-by-Calendar Quarter basis, if during any Calendar Quarter in the Royalty Term for a given Licensed Product in a given country, there is no Valid Claim of a Dartsbio Product-Specific Licensed Patent Covering such Licensed Product in such country, then the applicable royalty rates set forth in Section 8.4(a) shall be reduced by [***], for such Licensed Product in such country in such Calendar Quarter.
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(d) Biosimilar Product Reduction. On a Licensed Product-by-Licensed Product, country-by-country and Calendar Quarter-by-Calendar Quarter basis, if during any Calendar Quarter in the Royalty Term for a given Licensed Product in a given country, one or more Biosimilar Product is launched in such country with respect to a Licensed Product, and (x) the unit volume of all Biosimilar Products to such Licensed Product that are sold by Third Parties in such country is equal to or exceeds [***] of the combined unit volume of such Licensed Product and such Biosimilar Products sold in such country during such Calendar Quarter but less than [***], then, the royalties due for the Net Sales of such Licensed Product in such country for such Calendar Quarter hereunder shall be reduced by [***] for such Calendar Quarter; and (y) the unit volume of all Biosimilar Products to such Licensed Product that are sold by Third Parties in such country is equal to or exceeds [***] of the combined unit volume of such Licensed Product and such Biosimilar Products sold in such country during such Calendar Quarter, then, the royalties due for the Net Sales of such Licensed Product in such country for such Calendar Quarter hereunder shall be reduced by [***] for such Calendar Quarter.
(e) Third Party Intellectual Property. If Slate Medicines in its good faith judgment believes that it is [***] to obtain a license (except a license for commercial host CHO cell line) from any Third Party (“Third Party License”) under any Patent in order to Develop, manufacture or Commercialize any Licensed Product(s) in any country, Slate Medicines may deduct from any royalties payable to Dartsbio under this Section 8.4 [***] of all consideration paid by Slate Medicines or its Affiliates or Sublicensees for such Third Party Licenses. [***]. Notwithstanding the foregoing, a Third Party License shall exclude licenses to the composition of matter of any antibody sequence that is included within a Licensed Product that is not directed to the Targets.
(f) Inflation Reduction Act. With respect to the calculation of royalties in the United States, if a Licensed Product is selected as a Selected Drug by the Secretary of the US Department of Health and Human Services and is subject to a Maximum Fair Price under the Inflation Reduction Act, then, subject to Section 8.4(g), the applicable royalty rates for the Net Sales of such Licensed Product in the United States shall be reduced by [***].
(g) Royalty Floor; Carry Over. The payment reductions set forth in Sections 8.4(c), 8.4(d), 8.4(e) and 8.4(f) shall be applied on a cumulative basis; provided, that in no event shall any royalties payable to Dartsbio under this Agreement for any Licensed Product in a given Calendar Quarter in a country be reduced pursuant to Section 8.4 hereunder to less than [***] of the royalty amount that would otherwise have been payable to Dartsbio for such Licensed Product in such Calendar Quarter in such country. To the extent a reduction set forth in Sections 8.4(c), 8.4(d), 8.4(e) or 8.4(f) is not used to reduce such amounts payable by Slate Medicines during a Calendar Quarter, such reduction (or the applicable portion) may be carried forward to the following Calendar Quarters (as if applied during such following Calendar Quarters for purposes of Sections 8.4(c), 8.4(d), 8.4(e) and 8.4(f)).
8.5 Sublicensing Revenue Sharing. Slate Medicines shall pay to Dartsbio a portion of all Sublicensing Revenue as follows:
[***].
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8.6 Royalty Payments; Reports. Royalties under Section 8.4 shall be calculated and reported for each Calendar Quarter during the Royalty Term and shall be paid within [***] after the end of the applicable Calendar Quarter, commencing with the Calendar Quarter in which the First Commercial Sale of a Licensed Product occurs. Each payment of royalties shall be accompanied by a report of Net Sales of Licensed Products by Slate Medicines, its Affiliates and their respective Sublicensees in sufficient detail to permit confirmation of the accuracy of the royalty payment made, including: (a) the amount of [***] of Licensed Products in the Slate Medicines Territory [***], (b) [***], and (c) a calculation of the amount of royalties due to Dartsbio in U.S. Dollars, including the application of any exchange rate used. Additionally, within [***] after the end of each Calendar Quarter during the Term, Slate Medicines shall deliver to Dartsbio a statement of Sublicensing Revenue received during the applicable Calendar Quarter and a calculation of the amount of Sublicensing Revenue sharing due for such Calendar Quarter. Along with such reports, Slate Medicines shall pay Dartsbio the Sublicensing Revenue sharing payment due for such Calendar Quarter.
8.7 Payment Method; Foreign Exchange. All payments owed by Slate Medicines under this Agreement shall be made by wire transfer in immediately available funds to a bank and account designated in writing by Dartsbio. For clarity, all payments by Slate Medicines to Dartsbio pursuant to Sections 8.1, 8.2, 8.3, 8.4, and 8.5 shall be in U.S. Dollars. The rate of exchange to be used in computing the amount of currency equivalent in U.S. Dollars of any amounts payable in U.S. Dollars by Slate Medicines to Dartsbio under this Agreement shall be determined and calculated using the average rate of exchange based on OANDA Corporation rates (or the rates listed by any similar entity in the event that OANDA Corporation no longer provides such rates) for the Calendar Quarter in which the applicable payment is due.
8.8 Interest on Late Payments. If Dartsbio does not receive payment of any sum due to it on or before the due date, interest shall thereafter accrue on the sum due to Dartsbio until the date of payment at the per annum rate of [***] or the maximum rate allowable by applicable Laws, whichever is lower.
8.9 Records; Audits. Slate Medicines shall, and shall cause its Affiliates and their respective Sublicensees to, maintain in accordance with Accounting Standards, reasonably complete and accurate records in sufficient detail to permit Dartsbio to confirm the accuracy of the calculation of royalty payments, Sublicensing Revenue sharing payments and the achievement of the milestone events. All payments and other relevant amounts under this Agreement shall be accounted for in accordance with Accounting Standards. Upon reasonable prior written notice, in any event no less than [***] prior written notice, such records shall be available for examination during regular business hours and in a manner that does not interfere with Slate Medicines’ business activities for a period of [***] from the end of the Fiscal Year to which they pertain, and not more often than once each Fiscal Year, by an internationally-recognized independent certified public accountant selected by Dartsbio and reasonably acceptable to Slate Medicines, for the sole purpose of verifying the accuracy of the financial reports furnished by Slate Medicines pursuant to this Agreement and any payments with respect thereto. Any such auditor shall not disclose Slate Medicines’ Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by Slate Medicines or the amount of payments due under this Agreement. Any amounts shown to be owed but unpaid shall be paid within [***] from the accountant’s report, plus interest (as set forth in Section 8.8) from the original due date.
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Dartsbio shall bear the full cost of such audit unless such audit discloses an underpayment by Slate Medicines of more than [***] of the amount due for the audited period, in which case Slate Medicines shall bear the full cost of such audit.
8.10 Taxes.
(a) Taxes on Income. Except as set forth in this Section 8.10, each Party shall be solely responsible for the payment of all taxes imposed on its share of income arising directly or indirectly from the efforts of the Parties under this Agreement. Neither Party shall have any obligation towards the other Party in case that the other Party fails to fully comply with its Tax obligations.
(b) Withholding Income Taxes. To the extent any payments made by Slate Medicines pursuant to this Agreement become subject to withholding income Taxes under applicable Laws, Slate Medicines shall deduct and withhold the amount of such Taxes for the account of Dartsbio to the extent required by applicable Laws; such amounts payable to Dartsbio shall be reduced by the amount of withholding income Taxes deducted and withheld; and Slate Medicines shall pay the amounts of such Taxes to the proper Governmental Authority in a timely manner and transmit to Dartsbio an official tax certificate or other evidence of such Tax obligations together with proof of payment from the relevant Governmental Authority of all amounts deducted and withheld sufficient to enable Dartsbio to claim such payment of Taxes. Any such withholding income Taxes required under applicable Laws to be paid or withheld shall be an expense of, and borne solely by, Dartsbio. If Dartsbio is entitled (whether under any applicable tax treaty or otherwise under applicable Laws) to a reduction in the rate of, or the elimination of, withholding income Tax, it may deliver to Slate Medicines or the appropriate Governmental Authority (with the assistance of Slate Medicines to the extent that this is reasonably required and is expressly requested in writing) the prescribed forms necessary to reduce the applicable rate of withholding or to relieve Slate Medicines of its obligation to withhold Tax, and Slate Medicines shall apply the reduced rate of withholding, or dispense with withholding, as the case may be. Slate Medicines agrees to take reasonable and lawful efforts to minimize such withholding income Taxes that would otherwise be borne by Dartsbio. Slate Medicines shall cooperate with Dartsbio as reasonably requested in any claim for refund or application to any Governmental Authority.Additionally, to the extent that any payment is agreed by the Parties not to be subject to withholding tax, Dartsbio shall indemnify and hold harmless Slate Medicines from and against any withholding Taxes imposed by any Governmental Authority on such payments made or required to be made to Dartsbio under this Agreement, together with any interest and penalties, regardless of whether such Taxes are assessed as a result of an audit, recharacterization, or subsequent determination by a Governmental Authority, except to the extent such Taxes arise from Slate Medicines’s failure to withhold after a final determination that withholding was required. Slate Medicines may offset any amounts owed by Dartsbio under this Section 8.10(b) against any amounts otherwise payable to Dartsbio under this Agreement.
(c) VAT. All payments due to Dartsbio from Slate Medicines pursuant to this Agreement shall be paid exclusive of, and without reduction for, any value-added tax (including, for greater certainty, any goods and services tax, harmonized sales tax and any similar taxes) (“VAT”) (which, if applicable, shall be payable by Slate Medicines). Slate Medicines shall be responsible for the payment of all VAT applicable to the payments made by Slate Medicines to
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Dartsbio under this Agreement and shall file all applicable VAT tax returns. Dartsbio shall cooperate, to the extent reasonably required, with the filing of any such VAT tax returns. Slate Medicines shall indemnify Dartsbio for any VAT imposed on Dartsbio with respect to the payments made to it by Slate Medicines under this Agreement and if Dartsbio directly pays any VAT, Slate Medicines shall promptly reimburse Dartsbio for such VAT including all reasonable related costs. If Dartsbio determines that it is required to report any such tax, Slate Medicines shall promptly provide Dartsbio with applicable receipts and other documentation necessary or appropriate for such report. For clarity, this Section 8.10(c) is not intended to limit Slate Medicines’ right to deduct VAT in determining Net Sales.
ARTICLE 9
INTELLECTUAL PROPERTY MATTERS
9.1 Ownership; License Grants.
(a) Data. Dartsbio shall solely own all Data generated by Dartsbio. For clarity, all Data Controlled by Dartsbio as of the Effective Date and during the Term satisfying the criteria of Dartsbio Licensed Know-How are licensed to Slate Medicines under Section 2.1(a). Slate Medicines shall solely own all Data generated by Slate Medicines in the Development of Licensed Products in the Field in the Slate Medicines Territory. For clarity, all Data satisfying the criteria of Slate Medicines Technology are licensed to Dartsbio under Section 2.2.
(b) Inventions. Inventorship of any Invention will be determined in accordance with the standards of inventorship and conception under U.S. patent laws.
(i) Background IP. Other than the Dartsbio Technology, neither Party nor its Affiliates will acquire any interest in all intellectual property (including without limitation all data regardless whether it is protectable under the patent, trademark, copyright, database or other Applicable Laws) that is either (i) owned or controlled by the other Party or any of its Affiliates prior to the Effective Date or (ii) developed or acquired by the other Party independently from the performance of the activities under this Agreement.
(ii) Dartsbio Inventions. As between the Parties, any Invention generated, developed, conceived or reduced to practice (constructively or actually) solely by or on behalf of Dartsbio, its Affiliates and their respective licensees (other than Slate Medicines), including their employees, agents and contractors (“Dartsbio Inventions”) shall be solely and exclusively owned by Dartsbio. For clarity, any and all Dartsbio Inventions that are Controlled by Dartsbio as of the Effective Date and during the Term satisfying the definition of Dartsbio Technology shall be licensed to Slate Medicines under Section 2.1(a), including any Patent rights therein.
(iii) Slate Medicines Inventions. As between the Parties, any Inventions generated, developed, conceived or reduced to practice (constructively or actually) solely by or on behalf of Slate Medicines, its Affiliates and their respective Sublicensees, including their employees, agents and contractors (“Slate Medicines Inventions”) shall be solely and exclusively owned by Slate Medicines. For clarity, any and all Slate Medicines Inventions satisfying the definition of Slate Medicines Technology shall be licensed to Dartsbio under Section 2.2, including any Patent rights therein.
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(iv) Joint Inventions. Any Invention generated, developed, conceived or reduced to practice (constructively or actually) jointly by or on behalf of Slate Medicines and Dartsbio, their Affiliates and respective Sublicensees, including their employees, agents and contractors (“Joint Inventions”) shall be jointly owned by the Parties, and, subject to the licenses set forth in this Agreement, each Party may freely exploit such Joint Inventions without any duty to account to the other Party. For clarity, any and all Joint Inventions satisfying the definition of Dartsbio Technology or Slate Medicines Technology, shall be licensed to Slate Medicines under Section 2.1(a) or to Dartsbio under Section 2.2, as applicable, including any Patent rights therein.
9.2 Patent Prosecution.
(a) Definition. For the purpose of this Article 9, “prosecution” of Patents shall include, without limitation, all communication and other interaction with any patent office or patent authority having jurisdiction over a Patent application throughout the world in connection with any pre-grant proceedings and post-grant proceeding, including opposition proceedings.
(b) Dartsbio Product-Specific Licensed Patents. Except as set forth in Section 9.2(e), as between the Parties, Slate Medicines shall have the first right, at its sole expense and in Dartsbio’s name, to prepare and file all Dartsbio Product-Specific Licensed Patents worldwide and prosecute, maintain or abandon all Dartsbio Product-Specific Licensed Patents in the Slate Medicines Territory; provided, however, that Slate Medicines does not represent or warrant that any patent will issue or be granted based on patent applications contained in the Dartsbio Product-Specific Licensed Patents in the Slate Medicines Territory. Slate Medicines’ and Dartsbio’s patent counsel (and other personnel, as necessary) will meet, in-person or telephonically at a mutually agreeable time and location, to discuss the status and strategy regarding the filing of the Dartsbio Product-Specific Licensed Patents. Additionally, after the initial filing of any Dartsbio Product-Specific Licensed Patent in the Dartsbio Territory, Slate Medicines will transfer to Dartsbio further responsibility for prosecution and maintenance of such Dartsbio Product-Specific Licensed Patent. Slate Medicines shall provide Dartsbio with a copy of the draft prepared for the filing of a Dartsbio Product-Specific Licensed Patent before the filing of such Dartsbio Product-Specific Licensed Patent and will incorporate comments thereto provided by Dartsbio in good faith in connection with the filing thereof. Slate Medicines shall provide Dartsbio with regular updates on the prosecution of the Dartsbio Product-Specific Licensed Patents in the Slate Medicines Territory. As between the Parties, upon transition of prosecution and maintenance by Slate Medicines to Dartsbio, Dartsbio shall have the sole right, at its sole expense, to prosecute and maintain or abandon all Dartsbio Product-Specific Licensed Patents in the Dartsbio Territory; provided, however, that Dartsbio does not represent or warrant that any patent will issue or be granted based on patent applications contained in the Dartsbio Product-Specific Licensed Patents in the Dartsbio Territory.
(c) Slate Medicines Patents. Slate Medicines shall have the sole right to prepare, file, prosecute and maintain or abandon the Slate Medicines Patents on a worldwide basis. For clarity, Dartsbio shall not have any rights pursuant to this Agreement with respect to any Slate Medicines Patents (including any Step-In Rights relating thereto).
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(d) Joint Patents.
(i) Except as set forth in Section 9.2(e), as between the Parties, Slate Medicines shall have the first right to prepare and file the Product Specific Joint Patents worldwide, and prosecute and maintain or abandon the Product Specific Joint Patents in the Slate Medicines Territory; provided, however, that Slate Medicines does not represent or warrant that any patent will issue or be granted based on patent applications contained in the Product Specific Joint Patents in the Slate Medicines Territory. Additionally, after the initial filing of any Product Specific Joint Patents in the Dartsbio Territory, Slate Medicines will transfer to Dartsbio further responsibility for prosecution and maintenance of such Product Specific Joint Patent. Slate Medicines shall provide Dartsbio with a copy of the draft prepared for the filing of a Product Specific Joint Patent before the filing of such Product Specific Joint Patent and will consider in good faith comments thereto provided by Dartsbio in connection with the filing thereof. Slate Medicines shall provide Dartsbio with regular updates on the prosecution of the Product Specific Joint Patents.
(ii) Except as set forth in Section 9.2(e), as between the Parties, upon transition of prosecution and maintenance by Slate Medicines to Dartsbio, Dartsbio shall have the first right to prosecute and maintain or abandon the Product Specific Joint Patents in the Dartsbio Territory; provided, however, that Dartsbio does not represent or warrant that any patent will issue or be granted based on patent applications contained in the Product Specific Joint Patents in the Dartsbio Territory. Dartsbio shall provide Slate Medicines with regular updates on the prosecution of the Product Specific Joint Patents.
(e) Step-In Rights. Either Party may cease prosecution and/or maintenance of any Patent that such Party is responsible for prosecuting and maintain pursuant to this Section 9.2 on a country-by-country basis by providing the other Party written notice reasonably in advance of such due date. If the responsible Party elects to cease prosecution or maintenance of the relevant Patent or does not file the relevant Patent in a country, the other Party, shall have the right, but not the obligation, at its sole discretion and cost, to continue prosecution or maintenance or filing of such Patent and in such country (“Step-In Rights”), provided that Dartsbio may only exercise its Step-In Rights with respect to Product Specific Joint Patents and Dartsbio Product-Specific Licensed Patents; provided, further that Slate Medicines shall not exercise a Step-In Right with respect to Dartsbio Product-Specific Licensed Patents in the Dartsbio Territory. If the other Party elects to continue prosecution or maintenance or elects to file additional applications following the responsible Party’s election to cease prosecution or maintenance pursuant to this Section 9.2(e), the responsible Party shall transfer the applicable patent files to such other Party or its designee and execute such documents and perform such acts at the responsible Party’s expense as may be reasonably necessary to allow the other Party to initiate or continue such filing, prosecution or maintenance at the other Party’s sole expense.
(f) Cooperation. Each Party shall provide the other Party with all reasonable assistance and cooperation in the patent prosecution efforts set forth in this Section 9.2, including providing any necessary powers of attorney and executing any other required documents or instruments for such prosecution.
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9.3 Patent Term Extensions in the Slate Medicines Territory. The JSC will discuss and recommend for which, if any, of the Patents within the Dartsbio Product-Specific Licensed Patents, Slate Medicines Patents and Joint Patents in the Slate Medicines Territory the Parties should seek patent term extensions. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC, the representatives of the Parties cannot reach an agreement as to which Patents such extensions should be sought for, Slate Medicines shall have the final decision-making authority with respect to applying for any such patent term extension in the Slate Medicines Territory. Each Party will cooperate fully with the other Party in making such filings or actions, for example and without limitation, making available all required regulatory Data and Information and executing any required authorizations to apply for such patent term extension. All expenses incurred in connection with activities of each Party with respect to the Patent(s) for which such Slate Medicines seeks patent term extensions pursuant to this Section 9.3 shall be borne by Slate Medicines.
9.4 Patent Enforcement.
(a) Notification; Information Sharing. If either Party becomes aware of any existing or threatened infringement of any Dartsbio Product-Specific Licensed Patent, Slate Medicines Patent or Joint Patent by a Third Party product that is (i) a product directed to the Targets or a product directed to the Targets and any other targets prior to Dartsbio entering into a Dartsbio CGRP License (including pursuant to a CGRP Collaboration) with a party other than Slate Medicines or its Affiliate, or (ii) a product directed to the Targets and any other targets other than CGRP, following Dartsbio entering into a Dartsbio CGRP License (including pursuant to a CGRP Collaboration) with a party other than Slate Medicines or its Affiliate (collectively, “Infringement”), it shall promptly notify the other Party in writing to that effect and the Parties will consult with each other regarding any actions to be taken with respect to such Infringement. Each Party shall share with the other Party all information available to it regarding such alleged Infringement, pursuant to a mutually agreeable “common interest agreement” executed by the Parties under which the Parties agree to their shared, mutual interest in the outcome of any suit or other action to enforce the Dartsbio Licensed Patents, Slate Medicines Patent and Joint Patent against such Infringement.
(b) Enforcement Rights.
(i) Dartsbio Product-Specific Licensed Patents.
(1) Slate Medicines shall have the first right, but not the obligation, to bring an appropriate suit or other action against any Person engaged in the Infringement of any Dartsbio Product-Specific Licensed Patent in the Slate Medicines Territory in the Field, at Slate Medicines’ cost and expense. If Slate Medicines elects to commence a suit or other action to enforce the applicable Dartsbio Product-Specific Licensed Patent against such Infringement, then Dartsbio shall have the right to join such enforcement action upon written notice to Slate Medicines, and the Parties shall share the cost and expense of such enforcement action equally. If Slate Medicines notifies Dartsbio in writing that it does not intend to commence a suit or other action to enforce the applicable Dartsbio Product-Specific Licensed Patent against such Infringement or to take other action to secure the abatement of such Infringement, or fails to take any such action after a period of [***] following either Party’s receipt of the notice of Infringement pursuant to Section 9.4(a), then, Dartsbio shall have the right, but not the obligation, to commence such a suit or take such action, at Dartsbio’s cost and expense. In such case, Slate
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Medicines shall take appropriate actions in order to enable Dartsbio to commence a suit or take the actions set forth in the preceding sentence. Notwithstanding the foregoing, if Slate Medicines decides, after prior consultation with Dartsbio, not to take action or defend against such Infringement because Slate Medicines believes in good faith that such action or defense would be reasonably likely to have an adverse impact on the Exploitation of Licensed Products or the prosecution and maintenance of Dartsbio Product-Specific Licensed Patent or Joint Patents, then Dartsbio shall not have the right to exercise such step-in enforcement rights.
(2) Neither Party shall settle any such suit or action under 9.4(b)(i)(1) in any manner that would negatively impact the Dartsbio Product-Specific Licensed Patents or that would limit or that would limit or restrict the ability of Dartsbio or Slate Medicines to sell the Licensed Products in the Dartsbio Territory or Slate Medicines Territory, respectively, without the prior written consent of the other Party. For clarity, Dartsbio shall have the sole right to enforce Dartsbio Product-Specific Licensed Patent for any infringement that is not an Infringement.
(ii) Slate Medicines Patents. Slate Medicines shall have the sole right, but not the obligation, to bring an appropriate suit or other action against any Person engaged in the Infringement of any Slate Medicines Patent, at Slate Medicines’ cost and expense.
(iii) Product Specific Joint Patents.
(1) Slate Medicines shall have the first right, but not the obligation, to bring an appropriate suit or other action against any Person engaged in the Infringement of any Product Specific Joint Patent in Slate Medicines Territory, at Slate Medicines’ cost and expense. If Slate Medicines elects to commence a suit or other action to enforce the applicable Product Specific Joint Patent against such Infringement, then Dartsbio shall have the right to join such enforcement action upon written notice to Slate Medicines, and the Parties shall share the cost and expense of such enforcement action equally. If Slate Medicines notifies Dartsbio in writing that it does not intend to commence a suit or other action to enforce the applicable Product Specific Joint Patent against such Infringement or to take other action to secure the abatement of such Infringement, or fails to take any such action after a period of [***] following either Party’s receipt of the notice of Infringement pursuant to Section 9.4(a), then, Dartsbio shall have the right, but not the obligation, to commence such a suit or take such action, at Dartsbio’s cost and expense. In such case, Slate Medicines shall take appropriate actions in order to enable Dartsbio to commence a suit or take the actions set forth in the preceding sentence. Notwithstanding the foregoing, if Slate Medicines decides, after prior consultation with Dartsbio, not to take action or defend against such Infringement because Slate Medicines believes in good faith that such action or defense would be reasonably likely to have an adverse impact on the Exploitation of Licensed Products or the prosecution and maintenance of Dartsbio Product-Specific Licensed Patent or Product Specific Joint Patents, then Dartsbio shall not have the right to exercise such step-in enforcement rights.
(2) Dartsbio shall have the first right, but not the obligation, to bring an appropriate suit or other action against any Person engaged in the Infringement of any Product Specific Joint Patent in Dartsbio Territory, at Dartsbio’s cost and expense. If Dartsbio elects to commence a suit or other action to enforce the applicable Product Specific Joint Patent
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against such Infringement, then Slate Medicines shall have the right to join such enforcement action upon written notice to Dartsbio, and the Parties shall share the cost and expense of such enforcement action equally. If Dartsbio notifies Slate Medicines in writing that it does not intend to commence a suit or other action to enforce the applicable Product Specific Joint Patent against such Infringement or to take other action to secure the abatement of such Infringement, or fails to take any such action after a period of [***] following either Party’s receipt of the notice of Infringement pursuant to Section 9.4(a), then, Slate Medicines shall have the right, but not the obligation, to commence such a suit or take such action, at Slate Medicines’ cost and expense. In such case, Dartsbio shall take appropriate actions in order to enable Slate Medicines to commence a suit or take the actions set forth in the preceding sentence.
(3) Neither Party shall settle any such suit or action under 9.4(b)(iii)(1) in any manner that would negatively impact the Product Specific Joint Patents or that would limit or restrict the ability of Dartsbio or Slate Medicines to sell the Licensed Products in the Dartsbio Territory or Slate Medicines Territory, respectively, without the prior written consent of the other Party.
(iv) Other Joint Inventions. Slate Medicines and Dartsbio shall share responsibilities and decision-making with regard to patent matters relating to all other Joint Invention and shall share costs with respect thereto, unless otherwise agreed between the Parties.
(c) Collaboration. Each Party shall provide to the Party bringing a claim, suit or action under Section 9.4 (the “Enforcing Party”) with reasonable assistance in such enforcement, including joining such action as a party plaintiff if required by applicable Laws to pursue such action. The Enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts, and shall reasonably consider the other Party’s comments on any such efforts. The non-enforcing Party shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully with the Enforcing Party.
(d) Expenses and Recoveries. The Enforcing Party shall be solely responsible for any expenses it incurs as a result of such enforcement action, except that the Parties shall share equally the cost and expense of the enforcement action when one Party is the Enforcing Party and the other Party elects to join the enforcement action. If the Enforcing Party recovers monetary damages in such claim, suit or action brought under Section 9.4, such recovery shall be allocated [***].
(e) Survival. Sections 9.4(c) and 9.4(d) shall survive the termination of this Agreement solely with respect to any pending enforcement action initiated during the Term under this Section 9.4.
9.5 Third Party Infringement Claims. If the Manufacture, use or sale of the Licensed Products in the Field in the Slate Medicines Territory pursuant to this Agreement results in a claim, suit or proceeding alleging patent infringement against Dartsbio or Slate Medicines (or their respective Affiliates, licensees or Sublicensees) (collectively, “Infringement Actions”), such Party shall promptly notify the other Party hereto in writing. Subject to Article 11, the Party for which the Infringement Action is brought against (the “Accused Party”) shall have the right to
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direct and control the defense of such Infringement Action, at its own expense with counsel of its choice; provided, however, that the other Party may participate in the defense and/or settlement thereof, at its own expense with counsel of its choice. In any event, the Accused Party agrees to keep the other Party reasonably informed of all material developments in connection with any such Infringement Action for which the Accused Party exercises its right to direct and control the defense. The Accused Party agrees not to settle such Infringement Action, or make any admissions or assert any position in such Infringement Action, in a manner that would adversely affect the rights or interests of the other Party, without the prior written consent of the other Party, which shall not be unreasonably withheld or delayed. Subject to Article 11, if the Accused Party does not exercise its right to direct and control the defense of an Infringement Action that is brought against the other Party, then the other Party shall have such right and it shall agree to keep the Accused Party reasonably informed of all material developments in connection with such Infringement Action and it shall not settle such Infringement Action, or make any admissions or assert any position in such Infringement Action, in a manner that would materially adversely affect the rights or interests of the Accused Party, without the prior written consent of the Accused Party, which shall not be unreasonably withheld or delayed.
ARTICLE 10
REPRESENTATIONS AND WARRANTIES; COVENANTS
10.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party, as follows:
(a) Corporate Existence. As of the Effective Date, it is a company or corporation duly organized, validly existing, and in good standing under the Laws of the jurisdiction in which it is incorporated;
(b) Corporate Power, Authority and Binding Agreement. As of the Effective Date, (i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (iii) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium and similar Laws affecting creditors’ rights and remedies generally;
(c) No Conflict. The execution and delivery of this Agreement, the performance of such Party’s obligations in the conduct of the Development Plan and the license to be granted pursuant to this Agreement (i) do not and will not conflict with or violate any requirement of applicable Law existing as of the Effective Date; (ii) do not and will not conflict with or violate the certificate of incorporation or by-laws (or other constating documents) of such Party; and (iii) do not and will not conflict with, violate, breach or constitute a material default under any contractual obligations of such Party or any of its Affiliates existing as of the Effective Date;
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(d) No Violation. Neither such Party nor any of its Affiliates is under any obligation to any Person, contractual or otherwise, that is in violation of the terms of this Agreement or that would impede the fulfillment of such Party’s obligations hereunder;
(e) No Debarment. Neither such Party nor any of its Affiliates is debarred or disqualified under the Act or comparable applicable Laws outside the U.S.; and
(f) No Consents. No authorization, consent, approval, whether internal or of a Third Party, nor to such Party’s knowledge, any license, permit, exemption of or filing or registration with or notification to any court or Governmental Authority is or will be necessary for the (i) valid execution and delivery of this Agreement by such Party; or (ii) the consummation by such Party of the transactions contemplated hereby that has not already been obtained prior to or by the Effective Date.
10.2 Additional Representations and Warranties of Dartsbio. Dartsbio represents and warrants to Slate Medicines, as of the Effective Date, as follows:
(a) Title; Encumbrances. (i) It solely owns the Dartsbio Licensed Patents and has sufficient legal and/or beneficial title or ownership with respect to the Dartsbio Technology, as necessary to grant the licenses to Slate Medicines as purported to be granted pursuant to this Agreement, free and clear from any mortgages, pledges, liens, security interests, conditional and installment sale agreement, encumbrances, charges or claim of any kind, and (ii) to Dartsbio’s knowledge, no Third Party has taken any action before the United States Patent and Trademark Office, or any counterpart thereof outside the U.S., claiming legal and/or beneficial title or ownership or license of any Dartsbio Technology;
(b) Third Party Technology. To Dartsbio’s knowledge, the Exploitation of Licensed Compounds or Licensed Products will not infringe or misappropriate any Patent or Information of a Third Party;
(c) Notice of Infringement or Misappropriation. It has not received any written notice from any Third Party asserting or alleging that (i) any Exploitation of a Licensed Product by Dartsbio prior to the Effective Date infringed or misappropriated the intellectual property rights of such Third Party, or (ii) the Exploitation of the Licensed Products in the Slate Medicines Territory would infringe or misappropriate the intellectual property rights of such Third Party;
(d) Non-Infringement of Rights by Third Parties. To Dartsbio’s knowledge, no Third Party is infringing or misappropriating or has infringed or misappropriated the Dartsbio Technology as of the Effective Date;
(e) Non-Assertion by Third Parties. To Dartsbio’s knowledge, no Third Party has asserted in writing that the issued patents within the Dartsbio Licensed Patents set forth in Schedule 1.22 are invalid or unenforceable;
(f) No Proceeding. There is no pending, and to Dartsbio’s knowledge, no threatened, adverse action, suit or proceeding against Dartsbio involving any of the Dartsbio Technology or the safety (including any product liability claim) of a Licensed Product;
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(g) Prosecution of Dartsbio Licensed Patents. All maintenance fees, annuity payments, and similar payments relating to the Dartsbio Product-Specific Licensed Patents in the Slate Medicines Territory, if any, have been made in a timely manner. To Dartsbio’s knowledge, prior to the Effective Date, Dartsbio has not taken action or failed to undertake an action, in connection with filing, prosecuting and maintaining the Dartsbio Product-Specific Licensed Patents set forth in Schedule 1.22 in the Slate Medicines Territory in violation of any applicable Law;
(h) Compliance with Laws. To Dartsbio’s knowledge, Dartsbio has complied with all applicable Laws in connection with the prosecution of the Dartsbio Product-Specific Licensed Patents, including the duty of candor owed to any patent office pursuant to such Laws;
(i) Dartsbio Licensed Patents. Dartsbio does not have knowledge of any Information which leads it to believe that any issued patents included in the Dartsbio Licensed Patents set forth in Schedule 1.22 are invalid or unenforceable;
(j) No Conflicts. Dartsbio has not entered, and shall not enter, into any agreement with any Third Party that is in conflict with the rights granted to Slate Medicines under this Agreement, and has not taken and shall not take any action that would in any way prevent it from granting the rights granted to Slate Medicines under this Agreement, or that would otherwise materially conflict with or adversely affect Slate Medicines’ rights under this Agreement; and
(k) Existing Agreements. Schedule 10.2(k) sets forth a true, complete and correct list of all agreements, whether written or oral, by and between Dartsbio and any of its Affiliates, on the one hand, and one (1) or more Third Parties, on the other hand, that solely relate to the Exploitation of any Licensed Compound or Licensed Product in the Slate Medicines Territory, including the conduct of pre-clinical Development activities or Clinical Trials (such agreements the “Existing Agreements”), excluding confidentiality and non-disclosure agreements entered into in the normal course. Each Existing Agreement is enforceable against each party to such Existing Agreement, and all such Existing Agreements are in full force and effect. There are no in-license or other agreements under which Dartsbio or any of its Affiliates obtains any rights to any intellectual property rights licensed to Slate Medicines hereunder. The rights and obligations of the Parties hereunder are fully consistent with, and are not limited in any material respect by, the Existing Agreements. Dartsbio shall promptly provide Slate Medicines with notice of any alleged, threatened or actual breach of any Existing Agreement. None of Dartsbio, its Affiliates and, to the Knowledge of Dartsbio, any Third Party is in breach of any Existing Agreement.
10.3 Compliance with Laws. Each Party shall, and shall ensure that its Affiliates and their respective Sublicensees and licensees will with all applicable Laws (including Anti-Corruption Laws) in the Exploitation of Licensed Products and performance of its obligations under this Agreement, including the ICH, GCP, GLP and any Regulatory Authority and Governmental Authority health care programs having jurisdiction in such Party’s respective territory, each as may be amended from time to time.
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10.4 Full Disclosure. As of the Effective Date, (a) the representations and warranties of Dartsbio in this Agreement, and (b) to Dartsbio’s knowledge, the information, documents and materials furnished to Slate Medicines in the digital data room established for purposes of this transaction hosted at Intralinks in connection with its period of diligence prior to the Effective Date, do not, taken as a whole, (i) contain any untrue statement of a material fact or (ii) omit to state any material fact necessary to make the statements or facts contained therein, in light of the circumstances under which they were made, not misleading.
10.5 Additional Dartsbio Covenants.
(a) Existing Agreements. Dartsbio shall not, and shall cause its Affiliates not to, enter into any subsequent agreement or understanding with any Third Party to an Existing Agreement that modifies, amends or terminates any such Existing Agreement, or waives any right or obligation thereunder, in each case, in any manner that would materially and adversely affect in any respect Slate Medicines’ rights or interests under this Agreement or would impose any obligation on Slate Medicines, in each case, without Slate Medicines’ prior written consent. Dartsbio shall not, and shall cause its Affiliates not to, commit any acts or permit the occurrence of any omissions that would cause breach or termination of any of its Existing Agreements where such breach or termination would materially and adversely affect in any respect Slate Medicines’ rights or interests under this Agreement or impose any obligation on Slate Medicines.
10.6 No Other Representations or Warranties. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY OR ITS AFFILIATES, AND ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED. FOR CLARITY AND WITHOUT LIMITING THE FOREGOING, DARTSBIO MAKES NO REPRESENTATION OR WARRANTY CONCERNING THE LICENSED PRODUCTS OR DARTSBIO TECHNOLOGY EXCEPT AS EXPRESSLY SET FORTH IN THIS ARTICLE 10.
ARTICLE 11
INDEMNIFICATION
11.1 Indemnification by Dartsbio. Dartsbio shall defend, indemnify, and hold Slate Medicines and its Affiliates and their respective officers, directors, employees, agents, successors and assigns (the “Slate Medicines Indemnitees”) harmless from and against any and all losses, damages, liabilities, actually incurred expenses and costs, including reasonable legal expense and attorneys’ fees (“Losses”) to which any Slate Medicines Indemnitee may become subject as a result of any claim, demand, action or other proceeding by any Third Party (collectively, “Claims”) arising out of, based on, or resulting from (a) the Exploitation of Licensed Products in the Slate Medicines Territory by or on behalf of Dartsbio or its Affiliates prior to the Effective Date, (b) the Exploitation of Licensed Products by or on behalf of Dartsbio or its Affiliates in the Dartsbio Territory, (c) the breach of any of Dartsbio’s obligations under this Agreement, including Dartsbio’s representations, warranties or covenants set forth herein, (d) the conduct of any pharmacovigilance-related activities set forth in Section 5.5 by or on behalf of Dartsbio (except to the extent that such Claim arises from Slate Medicines’ provision of false, misleading, inaccurate
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or incomplete information to Dartsbio under Section 5.5 or Slate Medicines’ breach of its obligations under the Pharmacovigilance Agreement), or (e) the willful misconduct or negligent acts of any Dartsbio Indemnitee. The foregoing indemnity obligation shall not apply to the extent that (i) the Slate Medicines Indemnitees fail to comply with the indemnification procedures set forth in Section 11.3 and Dartsbio’s defense of the relevant Claim is materially prejudiced by such failure, or (ii) any Claim arises from, is based on, or results from any activity or occurrence for which Slate Medicines is obligated to indemnify the Dartsbio Indemnitees under Section 11.2.
11.2 Indemnification by Slate Medicines. Slate Medicines shall defend, indemnify, and hold Dartsbio and its Affiliates and their respective officers, directors, employees, agents, successors and assigns (the “Dartsbio Indemnitees”) harmless from and against any and all Losses to which any Dartsbio Indemnitee may become subject as a result of any Claims arising out of, based on, or resulting from (a) the Exploitation of Licensed Products by or on behalf of Slate Medicines or its Affiliates or Sublicensees on or after the Effective Date in the Slate Medicines Territory, (b) the conduct of pre-clinical Development and Manufacture of Licensed Products in the Field in the Dartsbio Territory for sale and use in the Slate Medicines Territory, (c) the breach of any of Slate Medicines’ obligations under this Agreement, including Slate Medicines’ representations, warranties, or covenants set forth herein, (d) the conduct of any pharmacovigilance-related activities set forth in Section 5.5 by or on behalf of Slate Medicines (except to the extent that such Claim arises from Dartsbio’s provision of false, misleading, inaccurate or incomplete information to Slate Medicines under Section 5.5 or Dartsbio’s breach of its obligations under the Pharmacovigilance Agreement) or (e) the willful misconduct or negligent acts of any Slate Medicines Indemnitee. The foregoing indemnity obligation shall not apply to the extent that (i) the Dartsbio Indemnitees fail to comply with the indemnification procedures set forth in Section 11.3 and Slate Medicines’ defense of the relevant Claim is materially prejudiced by such failure, or (ii) any Claim arises from, is based on, or results from any activity or occurrence for which Dartsbio is obligated to indemnify the Slate Medicines Indemnitees under Section 11.1
11.3 Indemnification Procedures. The Party claiming indemnity under this Article 11 (the “Indemnified Party”) shall give written notice to the Party from whom indemnity is being sought (the “Indemnifying Party”) promptly after learning of such Claim and shall offer control of the defense of such Claim to the Indemnifying Party. The Indemnified Party shall provide the Indemnifying Party with reasonable assistance, at the Indemnifying Party’s expense, in connection with the defense of the Claim for which indemnity is being sought. The Indemnified Party may participate in and monitor such defense with counsel of its own choosing at its sole expense; provided, however, the Indemnifying Party shall have the right to assume and conduct the defense of the Claim with counsel of its choice. The Indemnifying Party shall not settle any Claim without the prior written consent of the Indemnified Party, not to be unreasonably withheld, unless the settlement involves only the payment of money. So long as the Indemnifying Party is actively defending the Claim in good faith, the Indemnified Party shall not settle or compromise any such Claim without the prior written consent of the Indemnifying Party. If the Indemnifying Party does not assume and conduct the defense of the Claim as provided above, (a) the Indemnified Party may defend against, consent to the entry of any judgment, or enter into any settlement with respect to such Claim in any manner the Indemnified Party may deem reasonably appropriate (and the Indemnified Party need not consult with, or obtain any consent from, the Indemnifying Party in connection therewith), and (b) the Indemnifying Party shall remain responsible to indemnify the Indemnified Party as provided in this Article 11. Notwithstanding anything contained in this Section 11.3, the provisions of Section 9.5 shall govern the defense of any Infringement Actions.
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11.4 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.4 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 11.1 OR 11.2, OR DAMAGES AVAILABLE FOR A PARTY’S GROSS NEGLIGENCE, WILLFUL MISCONDUCT, FRAUD, BREACH OF ITS CONFIDENTIALITY OBLIGATIONS IN ARTICLE 12.
11.5 Insurance. Slate Medicines shall procure and maintain insurance adequate to cover its obligations hereunder and consistent with normal business practices of prudent companies similarly situated. It is understood that such insurance shall not be construed to create a limit of Slate Medicines’ liability with respect to its indemnification obligations under this Article 11. Slate Medicines shall provide Dartsbio with written evidence of such insurance upon request. Slate Medicines shall provide Dartsbio with written notice at least thirty (30) days prior to the cancellation, non-renewal or material change in such insurance.
ARTICLE 12
CONFIDENTIALITY
12.1 Confidentiality. Each Party agrees that, during the Term and for a period of [***] thereafter, it shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement (which includes the exercise of any rights or the performance of any obligations hereunder or thereunder) any Confidential Information of the other Party, except to the extent expressly agreed in writing by the Parties. The foregoing confidentiality and non-use obligations shall not apply to any portion of the other Party’s Confidential Information that the receiving Party can demonstrate by competent written proof:
(a) was already known to the receiving Party or its Affiliate, other than under an obligation of confidentiality, at the time of disclosure by the other Party;
(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;
(c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party or its Affiliate in breach of this Agreement;
(d) was disclosed to the receiving Party or its Affiliate without any confidentiality obligations by a Third Party who, to the Party’s knowledge, had a legal right to make such disclosure and who did not obtain such information directly or indirectly from the other Party; or
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(e) was independently discovered or developed by the receiving Party or its Affiliate without use of or reference to the other Party’s Confidential Information, as evidenced by a contemporaneous writing.
For clarity, clauses (a), (d) and (e) above shall not limit Dartsbio’s confidentiality obligations with respect to Dartsbio Licensed Know-How that is specifically related to the Licensed Compound.
12.2 Authorized Disclosure. Notwithstanding the obligations set forth in Section 12.1, a Party may disclose the other Party’s Confidential Information and the terms of this Agreement to the extent:
(a) such disclosure is reasonably necessary (i) for the filing or prosecuting of Patent rights as contemplated herein; (ii) to comply with the requirements of Regulatory Authorities with respect to obtaining and maintaining Regulatory Approval of Licensed Product; (iii) for the prosecuting or defending litigation as contemplated herein; or (iv) for the Development of a Licensed Compound or Licensed Product in a Party’s respective territory;
(b) such disclosure is reasonably necessary to its or its Affiliate’s employees, agents, consultants, contractors, licensees or Sublicensees, on a need-to-know basis for the sole purpose of performing its obligations or exercising its rights hereunder; provided that in each case, the disclosees are bound by written obligations of confidentiality consistent with those contained in this Agreement; or
(c) such disclosure is reasonably necessary to comply with applicable Laws, including regulations or rules promulgated by applicable securities commissions (or other securities regulatory authorities), security exchanges, court order, administrative subpoena or order;
(d) such disclosure is reasonably necessary to such Party’s directors, attorneys, independent accountants or financial advisors for the sole purpose of enabling such directors, attorneys, independent accountants, or financial advisors to provide advice to the receiving Party, provided that in each such case on the condition that such directors, attorneys, independent accountants, and financial advisors are bound by confidentiality and non-use obligations consistent with those contained in this Agreement; and
(e) solely with respect to the terms of this Agreement and excluding disclosure of any other Confidential Information, such disclosure is reasonably necessary to any bona fide potential or actual investor, acquiror, merger partner, or other financial or commercial partner for the sole purpose of evaluating or carrying out an actual or potential investment, financing, acquisition or other business relationship; provided that in connection with such disclosure, such Party shall inform each disclosee of the confidential nature of such Confidential Information and require each disclosee to treat such Confidential Information as confidential.
Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Section 12.2(a) or 12.2(c), such Party shall promptly notify the other Party of such required disclosure, to the extent that it is legally authorized or permitted to so, and shall use reasonable efforts to obtain, or to assist the other Party in obtaining, where necessary, a protective order preventing or limiting the required disclosure.
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12.3 Publicity; Terms of Agreement.
(a) The Parties agree that the terms of this Agreement are the Confidential Information of both Parties, subject to the special authorized disclosure provisions set forth in this Section 12.3.
(b) Except as set forth on Schedule 12.3(b), neither Party shall issue any press release, trade announcement or make any other public announcement or statement with regard to the transactions contemplated by this Agreement without the other Party’s prior written consent. If either Party desires to make any additional public disclosure concerning the terms of this Agreement, such Party shall give the proposed text of such disclosure to the other Party reasonably in advance (but in any case no less than three (3) Business Days prior to the disclosure) for its prior review and approval (except as otherwise provided herein), which approval shall not be unreasonably withheld or delayed. A Party commenting on such a proposed disclosure shall provide its comments, if any, within three (3) Business Days after receiving the proposed disclosure for review (or such shorter period of time as necessitated by regulatory requirements). In relation to the other Party’s review of such an announcement, such other Party may make specific, reasonable comments on such proposed press release within the prescribed time for commentary. Neither Party shall be required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement that has already been publicly disclosed by such Party, or by the other Party, in accordance with this Section 12.3.
(c) The Parties acknowledge that either or both Parties or their Affiliates may be obligated to file under applicable Laws a copy of this Agreement with Governmental Authorities, including, without limitation, the U.S. Securities and Exchange Commission (the “SEC”). Each Party and its Affiliates shall be entitled to make such a required filing, provided that it requests confidential treatment of the commercial terms and sensitive technical terms hereof to the extent such confidential treatment is reasonably available. In the event of any such filing, each Party will provide the other Party with a copy of this Agreement marked to show provisions for which such Party or its Affiliate intends to seek confidential treatment and shall reasonably consider and incorporate the other Party’s timely comments thereon to the extent consistent with the legal requirements, with respect to the filing Party or Affiliate, governing disclosure of material agreements and material information that must be publicly filed.
12.4 Technical Publication.
(a) Each Party may publish peer reviewed manuscripts, or give other forms of public disclosure such as abstracts and presentations (each such presentation or publication a “Publication”), of results of studies carried out under this Agreement or otherwise pertaining to the Development of the Licensed Compound or Licensed Products in the Field.
(b) In the event that either Party intends to publish a Publication, such Party shall provide the other Party the opportunity to review and comment on any such proposed publication at least [***] for abstracts or [***] for manuscripts prior to its intended submission for publication. The publishing Party shall incorporate any comments thereto provided by the other Party and shall comply with the other Party’s request to remove any and all of such Party’s Confidential Information from the proposed publication. In addition, the publishing Party shall
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delay the submission for a period up to [***] in the event that the other Party can demonstrate reasonable need for such delay for the preparation and filing of a patent application. The publishing Party shall provide the other Party with a copy of the manuscript at the time of the submission. The publishing Party agrees to acknowledge the contributions of the other Party and its employees in all publications in accordance with scientific practices.
12.5 Equitable Relief. Each Party acknowledges that its breach of this Article 12 will cause irreparable harm to the other Party, which cannot be reasonably or adequately compensated in damages in an action at law. By reasons thereof, each Party agrees that the other Party shall be entitled, in addition to any other remedies it may have under this Agreement or otherwise, to preliminary and permanent injunctive and other equitable relief to prevent or curtail any actual or threatened breach of the obligations relating to Confidential Information set forth in this Article 12 by the other Party.
ARTICLE 13
TERM AND TERMINATION
13.1 Term. The term of this Agreement (the “Term”) shall commence upon the Effective Date and, unless earlier terminated pursuant to this Article 13, shall remain in effect until the expiration of the Royalty Term on a Licensed Product-by-Licensed Product and country-by-country basis. Upon the expiration (but not early termination) of this Agreement, on a Licensed Product-by-Licensed Product and country-by-country basis, the licenses granted hereunder by Dartsbio to Slate Medicines shall become fully paid-up, royalty free, irrevocable and perpetual.
13.2 Termination by Slate Medicines. Slate Medicines may terminate this Agreement either on a Licensed Product-by-Licensed Product basis or in its entirety for convenience upon (i) [***] prior written notice to Dartsbio (if such notice is provided before the First Commercial Sale of any Licensed Product in any country) or (ii) [***] prior written notice to Dartsbio (if such notice is provided following the First Commercial Sale of any Licensed Product in any country); provided, however, that in each case under (i) and (ii) Dartsbio may, in its discretion, upon prior written notice to Slate Medicines accelerate the effectiveness of such termination to the extent permitted by Law in the Slate Medicines Territory.
13.3 Patent Challenge. Dartsbio may terminate this Agreement in its entirety upon [***] prior written notice to Slate Medicines, if Slate Medicines or its Affiliates or their respective Sublicensees (directly or indirectly, individually or in association with any other Person) challenges the validity, enforceability or scope of any Dartsbio Licensed Patent, unless during such [***] period the subject challenge is permanently dismissed or withdrawn and is not thereafter reinstituted or continued; provided that in the event a Sublicensee of Slate Medicines initiates such challenge, Dartsbio may not terminate this Agreement if (i) Slate Medicines successfully causes such Sublicensee to abort such challenge within such [***] period, or (ii) Slate Medicines (A) provides Dartsbio a written notice of its intent to terminate its sublicense with such Sublicensee within such [***] period, and (B) successfully terminates such sublicense within such [***] period.
13.4 Termination for Breach. Each Party shall have the right to terminate this Agreement in its entirety immediately upon written notice to the other Party if the other Party materially breaches this Agreement and, after receiving written notice identifying such material
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breach in reasonable detail, fails to cure such material breach within [***] from the date of such notice; provided that, if either Party disputes (a) whether such material breach has occurred, or (b) whether the defaulting Party has cured such material breach, the Parties agree to resolve the dispute as expeditiously as possible under Article 14. It is understood and acknowledged that during the pendency of such a dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder.
13.5 Termination for Cessation of Development. Dartsbio may terminate this Agreement upon [***] prior written notice to Slate Medicines if, prior to [***], Slate Medicines, its Affiliates or Sublicensees fail to [***]. It is understood and acknowledged that during the pendency of such a dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder.
13.6 Termination Due to Bankruptcy. Either Party may terminate this Agreement if, at any time, the other Party files in any court or agency pursuant to any statute or regulation of any state, country or jurisdiction, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of that Party or of its assets, or if the other Party proposes a written agreement of composition or extension of its debts, or if the other Party is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition is not dismissed within [***] after the filing thereof, or if the other Party proposes or becomes a Party to any dissolution or liquidation, or if the other Party makes an assignment for the benefit of its creditors.
13.7 Effect of Termination. Upon any termination of this Agreement, the following shall apply (in addition to any other rights and obligations under this Agreement with respect to such termination):
(a) Licenses. All licenses and other rights granted by Dartsbio to Slate Medicines under this Agreement shall terminate. Dartsbio shall have a reversion of all rights previously licensed to Slate Medicines hereunder for which the relevant licenses have terminated on a fully paid-up and royalty-free basis.
(b) Wind-Down. Slate Medicines will responsibly wind-down, in accordance with accepted pharmaceutical industry norms and ethical practices, any on-going Clinical Trials for which it has responsibility hereunder. For clarity, Slate Medicines may wind-down any ongoing Clinical Trials prior to the date of termination in accordance with accepted pharmaceutical industry norms and ethical practices and Slate Medicines will be responsible for any costs associated with such wind-down.
(c) Regulatory Materials; Data. Slate Medicines shall (i) provide and assign to Dartsbio or its designee all Regulatory Materials, including Regulatory Approvals, for the Licensed Products to the extent possible under applicable Law in the Slate Medicines Territory, and (ii) promptly provide to Dartsbio all Data (to the extent not already provided to Dartsbio), including pharmacovigilance data, generated by or on behalf of Slate Medicines; provided that in each case of (i) and (ii), in the event of termination by Slate Medicines pursuant to Sections 13.4 due to breach by Dartsbio, such assignment and provision shall be subject to the financial terms as agreed by the Parties (provided, that if the Parties cannot agree on such financial terms within [***]
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after the effective date of such termination, Dartsbio will have the right to have such dispute resolved by binding baseball arbitration as set forth in Schedule 13.7). Additionally, Slate Medicines shall promptly return or destroy, at Dartsbio’s election, all Confidential Information of Dartsbio.
(d) Transition Assistance. Upon Dartsbio’s reasonable request, (i) Slate Medicines shall provide such assistance as may be reasonably necessary for Dartsbio to continue the Development and Commercialization of Licensed Products in the Slate Medicines Territory, to the extent Slate Medicines or its Affiliate is then performing or having performed such activities, including upon the reasonable request of Dartsbio, assigning (to the extent Slate Medicines has rights to assign) any agreements or arrangements Slate Medicines or its Affiliate have with any Third Party that are solely for the Development, distribution, sale or otherwise Commercialization of Licensed Products; and (ii) Slate Medicines shall provide Dartsbio with copies of any promotional and marketing materials generated by or on behalf of Slate Medicines with respect to Licensed Products prior to the effective date of termination. If this Agreement is terminated by Slate Medicines pursuant to Sections 13.4 due to breach by Dartsbio, Dartsbio shall bear all costs arising out of any of the transition assistance activities set forth in clause (i) or (ii) performed by Slate Medicines. If this Agreement is terminated by Slate Medicines pursuant to Section 13.2 or by Dartsbio pursuant to Sections 13.3 or 13.4, Slate Medicines shall bear all costs arising out of any of the transition assistance activities set forth in clause (i) or (ii) performed by Slate Medicines.
(e) Inventory. In the event that this Agreement is terminated in its entirety, Dartsbio shall have the right, but not the obligation, to purchase any and all of the inventory of Licensed Products held by Slate Medicines or its Affiliates as of the date of termination, at (i) no price if terminated pursuant to Sections 13.4 due to breach by Slate Medicines, or (ii) a price equal to the transfer price paid by Slate Medicines to Dartsbio or its acquisition cost for such inventory for other terminations. Slate Medicines shall also have the right to continue to be permitted to sell such inventory for up to at least [***] after the effective date of termination of this Agreement; provided that Slate Medicines continues to comply with all of its payment, reporting and audit obligations hereunder with respect to such Licensed Products.
(f) Terminated Product. In the event this Agreement is not terminated in its entirety, but rather is terminated on a Licensed Product-by-Licensed Product basis pursuant to Section 13.2, then, notwithstanding anything to the contrary in this Section 13.7, the consequences of termination described herein shall only apply to such terminated Licensed Product, and this Agreement shall remain in full force and effect with respect to all Licensed Products other than such terminated Licensed Product.
(g) Reversion License. Slate Medicines automatically grants Dartsbio, an exclusive, worldwide, right and license under all Slate Medicines Technology Controlled by Slate Medicines as of the effective date of termination that is reasonably necessary for the Development, Manufacture or Commercialization of the Licensed Products to research, Develop, Manufacture and Commercialize the Licensed Products (the “Reversion License”), provided that the Reversion License would not include any rights to any Combination Product or diagnostic product. In the event of termination by Slate Medicines pursuant to Sections 13.4 due to breach by Dartsbio, the Reversion License shall be subject to the financial terms as agreed by the Parties (provided, that if the Parties cannot agree on such financial terms within [***] after the effective date of such termination, Dartsbio will have the right to have such dispute resolved by binding baseball arbitration as set forth in Schedule 13.7).
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13.8 Survival. Any expiration or termination of this Agreement shall not affect rights or obligations of the Parties under this Agreement that have accrued prior to the date of expiration or termination. Notwithstanding anything to the contrary, the following provisions shall survive any expiration or termination of this Agreement: Section 9.4(e), Section 10.6, Section 13.7, this Section 13.8, Section 13.9, Article 8 (to the extent, and with respect to, any payment obligations that have accrued prior to the date of expiration or termination), Article 11, Article 12, Article 14, Article 15 and Article 1 (to the extent defined terms therein are referenced in any of the foregoing Sections or Article).
13.9 Termination Not Sole Remedy. Termination is not the sole remedy under this Agreement and, whether or not termination is effected and notwithstanding anything contained in this Agreement to the contrary, all other remedies shall remain available except as agreed to otherwise herein.
13.10 Slate Medicines Special Remedy. In the event that Slate Medicines would have the right to terminate this Agreement pursuant to Section 13.4, then, in lieu of exercising such termination right and effective as of the date on which such termination would have taken place: the amount of any future Development Milestone Payments, Sales Milestone Payments and royalties applicable to Net Sales of Licensed Products shall be reduced by a percentage [***].
ARTICLE 14
DISPUTE RESOLUTION
14.1 Disputes; Internal Resolution. The Parties recognize that disputes as to certain matters may from time to time arise that relate to either Party’s rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation. To accomplish this objective, the Parties agree that, except as otherwise provided in Section 3.2(d), if a dispute arises under or relates to this Agreement, including, without limitation, any alleged breach under this Agreement or any issue relating to the interpretation or application of this Agreement, and the Parties are unable to resolve such dispute within [***] after such dispute is first identified by either Party in writing to the other, the Parties shall refer such dispute to a senior executive of each of Dartsbio (or one of its Affiliates) and Slate Medicines (the “Executive Officers”) for attempted resolution by good faith negotiations within [***] after notice referring to the dispute is received. If the dispute is not resolved within such [***], then the dispute shall be resolved by arbitration in accordance with Section 14.2 and thereafter neither Party shall have any further obligation under this Section 14.1. Notwithstanding the foregoing, and without waiting for the expiration of any such [***] periods, each Party shall each have the right to apply to any court of competent jurisdiction for appropriate interim or provisional relief, as necessary to protect the rights or property of such Party.
14.2 Arbitration. All disputes arising out of or in connection with this Agreement, including any questions regarding its formation, existence, validity or termination, or the scope or
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applicability of this agreement to arbitrate, shall be finally settled by Singapore International Arbitration Centre (“SIAC”) in accordance with its arbitration rules of SIAC then in force in Singapore, by a tribunal comprised of three arbitrators. Each Party shall nominate one arbitrator and the two Party-nominated arbitrators shall nominate the third arbitrator, who shall serve as the presiding arbitrator, within [***] after the second arbitrator’s appointment.
(a) The seat, or legal place, of arbitration shall be Singapore. The language of the arbitration shall be English. The arbitral award shall be final and binding on the Parties, and the Parties undertake to carry out any award without delay. Judgment on the award may be entered in any court of competent jurisdiction.
(b) Each Party retains the right to apply to any court of competent jurisdiction for interim and/or conservatory measures, including pre-arbitral attachments or preliminary injunctions, and any such request shall not be deemed incompatible with, or a waiver of, this agreement to arbitrate.
(c) The existence and content of the arbitral proceedings and any rulings or awards shall be kept confidential by the Parties and members of the arbitral tribunal except (i) to the extent that disclosure may be required of a Party to fulfill a legal duty, protect or pursue a legal right, or enforce or challenge an award in bona fide legal proceedings before a state court or other judicial authority, (ii) with the consent of all Parties, (iii) where needed for the preparation or presentation of a claim or defense in this arbitration, (iv) where such information is already in the public domain other than as a result of a breach of this clause, or (v) by order of the arbitral tribunal upon application of a Party.
14.3 Governing Law. This Agreement shall be governed by and construed under, and all disputes arising under or in connection with this Agreement shall be resolved in accordance with, the laws of Singapore, without giving effect to any choice of law rules or principles. The United Nations Convention on International Contracts on the Sale of Goods does not apply to this Agreement and is expressly and entirely excluded.
ARTICLE 15
MISCELLANEOUS
15.1 Entire Agreement; Amendment. This Agreement, including the Schedules hereto, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to the subject matter hereof and supersedes, as of the Effective Date, all prior and contemporaneous agreements and understandings between the Parties with respect to the subject matter hereof, including the Confidentiality Agreement. The foregoing shall not be interpreted as a waiver of any remedies available to either Party as a result of any breach, prior to the Effective Date, by the other Party of its obligations under the Confidentiality Agreement. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth in this Agreement. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.
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15.2 Force Majeure. Both Parties shall be excused from the performance of their obligations under this Agreement to the extent that such performance is prevented by force majeure and the nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse shall be continued only for so long as (a) the condition constituting force majeure continues and (b) the nonperforming Party takes all reasonable efforts to remove the condition. For purposes of this Agreement, force majeure shall include conditions beyond the reasonable control of the applicable Party, which may include an act of God, war, civil commotion, terrorist act, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe, action or inaction of any Governmental Authority (including export controls), and failure of plant or machinery. Notwithstanding the foregoing, a Party shall not be excused from making payments owed hereunder because of a force majeure affecting such Party. If a force majeure persists for more than ninety (90) days, then the Parties will discuss in good faith the modification of the Parties’ obligations under this Agreement in order to mitigate the delays caused by such force majeure.
15.3 Export Control. Dartsbio agrees not to export, directly or indirectly, any technical data it acquires from or provides to Slate Medicines in violation of United States export laws or regulations before, upon or after the Effective Date. Each Party agrees that its performance hereunder shall at all times comply with all applicable Laws, rules, regulations and ordinances of the United States and all other applicable jurisdictions. Slate Medicines shall have the right to terminate this Agreement without any obligation to Dartsbio if the license Dartsbio grants hereunder is prohibited or delayed for more than one hundred twenty (120) days due to a violation of United States export laws and regulations.
15.4 Notices. Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement, and shall be addressed to the appropriate Party at the address specified below or such other address as may be specified by such Party in writing in accordance with this Section 15.4, and shall be deemed to have been given for all purposes (a) when received, if hand-delivered or sent by a reputable courier service, or (b) five (5) Business Days after mailing, if mailed by first class certified or registered airmail, postage prepaid, return receipt requested.
If to Dartsbio: [***]
If to Slate Medicines: [***]
with copies to (which shall not constitute notice):
[***]
15.5 No Strict Construction; Headings. This Agreement has been prepared jointly by the Parties and shall not be strictly construed against either Party. Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision. The headings of each Article and Section in this
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Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section. Except where the context otherwise requires, the use of any gender shall be applicable to all genders, and the word “or” is used in the inclusive sense (and/or). The term “including” as used herein means including, without limiting the generality of any description preceding such term.
15.6 Assignment; Change of Control.
(a) Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other Party which shall not be unreasonably withheld, except that either Party may make such an assignment or a transfer without the other Party’s consent but with prior written notice to an Affiliate of such Party.
(b) Notwithstanding Section 15.6(a), either Party may without such consent but with prior written notice to the other Party, assign this Agreement and its rights and obligations hereunder in connection with a Change of Control (other than pursuant to an assignment for the benefit of creditors).
(c) Any permitted assignee shall assume all obligations of its assignor under this Agreement. Any assignment or attempted assignment by either Party in violation of the terms of this Sections 15.6(a) and 15.6(b) shall be null, void and of no legal effect.
15.7 Performance by Affiliates. Each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.
15.8 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
15.9 Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable in any forum, such provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.
15.10 No Waiver. Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time.
15.11 Independent Contractors. Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to give either Party the power or
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authority to act for, bind, or commit the other Party in any way. Nothing herein shall be construed to create the relationship of partners, principal and agent, or joint-venture partners between the Parties.
15.12 English Language. This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Agreement.
15.13 Counterparts. This Agreement may be executed in one (1) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
15.14 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by one Party to the other Party are, and otherwise will be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or comparable provision of applicable bankruptcy or insolvency laws, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code or comparable provision of applicable bankruptcy or insolvency laws. The Parties agree that a Party that is a licensee of such rights under this Agreement will retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code or comparable provision of applicable bankruptcy or insolvency laws. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party to this Agreement under the U.S. Bankruptcy Code or comparable provision of applicable bankruptcy or insolvency laws, the other Party will be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, and same, if not already in its possession, will be promptly delivered to it (i) upon any such commencement of a bankruptcy or insolvency proceeding upon its written request therefor, unless the bankrupt Party elects to continue to perform all of its obligations under this Agreement, or (ii) if not delivered under (i) above, following the rejection of this Agreement by or on behalf of the bankrupt Party upon written request therefor by the other Party.
{Signature Page Follows}
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IN WITNESS WHEREOF, the Parties have executed this License Agreement in duplicate originals by their duly authorized officers as of the Effective Date.
| DARTSBIO PHARMACEUTICALS LTD. | SLATE MEDICINES, INC. | |||||||||
| By: | /s/ Chunhe Wang |
By: | /s/ Neil Buckley |
|||||||
| Name: | Chunhe Wang | Name: | Neil Buckley | |||||||
| Title: | President and CEO | Title: | CEO | |||||||
[Signature Page to License Agreement]
Schedule 1.22
[***]
Schedule 1.48
Licensed Compounds
[***]
Schedule 2.4
Initial Technology Transfer Plan
| [***] |
[***] |
[***] | ||||
| [***] |
[***] |
[***] |
Schedule 4.7
Pre-Clinical Development Activities
[***]
Schedule 7.2
Supply Terms
[***]
Schedule 7.3
Manufacturing Technology Transfer
[***]
Schedule 10.2(k)
Existing Agreements
[***]
Schedule 12.3(b)
Press Release
[***]
Schedule 13.7
Baseball Arbitration
Baseball Arbitration Procedure. In the event that the Parties are unable to agree on the consideration payable with respect to the Reversion License, Dartsbio will have the right to submit such matter to a third party expert (a “Third Party Expert”) acceptable to the Parties having relevant expertise with respect to the dispute and who has not had any material business relationship with either Party in the [***] prior to appointment. The Parties will use reasonable efforts to agree on the Third Party Expert within [***] after Dartsbio designates the dispute for arbitration. If the Parties cannot agree on a Third Party Expert within [***], each Party will nominate one third party expert within such [***] period, and the two third party experts selected will nominate the Third Party Expert within [***] after their nomination, and such third party expert will be the Third Party Expert for purpose of this Schedule 13.6.
Proposal of Terms. Within [***] of selection of the Third Party Expert, each Party will deliver to both the Third Party Expert and the other Party a draft of the final, definitive financial consideration proposed by such Party (the “Proposed Terms”) and a memorandum (the “Support Memorandum”) in support thereof, such Support Memorandum not exceeding [***] pages in length. The Parties will also provide the Third Party Expert with a copy of the Agreement. Within [***] after receipt of the other Party’s Proposed Terms and Support Memorandum, each Party may submit to the Third Party Expert (with a copy to the other Party) a response to the other Party’s Proposed Terms and Support Memorandum, such response not exceeding [***] pages in length. Neither Party may have any other communications (either written or oral) with the Third Party Expert; provided that the Third Party Expert may, in its discretion, convene a hearing to ask questions of the Parties and hear oral argument and discussion regarding each Party’s Proposed Terms and Support Memorandum, at which time each Party will have an agreed upon time to argue and present witnesses in support of its Proposed Terms.
Selection of Proposed Terms. Within [***] after the Third Party Expert is appointed, the Third Party Expert will select one of the two Proposed Terms (without modification) provided by the Parties which most closely reflects commercially reasonable financial consideration. In making its selection, (a) the Third Party Expert will not modify the terms or conditions of either Party’s Proposed Terms nor will the Third Party Expert combine provisions from both Proposed Terms and (b) the Third Party Expert will consider the relative merits of the Proposed Terms, the Support Memorandums and, if applicable, the oral arguments of the Parties. The Third Party Expert will make its decision known to both Parties as promptly as possible by delivering written notice to both Parties. The decision of the Third Party Expert will be final and binding on Slate Medicines, and specific performance may be ordered by any court of competent jurisdiction. Dartsbio may elect to reject such decision of the Third Party Expert, in which case, the Reversion License shall be null and void.