EX-10.1 5 d587760dex101.htm EX-10.1 EXECUTION VERSION LICENSE AGREEMENT by and between MERCK SHARP & DOHME CORP. and UROVANT SCIENCES GMBH [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange...
Exhibit 10.1
EXECUTION VERSION
by and between
MERCK SHARP & DOHME CORP.
and
UROVANT SCIENCES GMBH
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
THIS LICENSE AGREEMENT (this “Agreement”) is made and entered into this February 3, 2017 (the “Effective Date”), by and between Merck Sharp & Dohme Corp. a corporation organized and existing under the laws of the State of New Jersey (“Merck”), and Urovant Sciences GmbH (“Urovant”), a company organized and existing pursuant to the laws of Switzerland, [***]. Merck and Urovant are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
WHEREAS, Merck desires to grant to Urovant such a license,
For purposes of this Agreement, the following terms and variations on them shall have the following meanings, it being understood that words denoting the singular include the plural and vice versa:
1.2. | Applicable Laws shall mean and include all laws, regulations, rules, decrees, judicial and administrative orders, and governmental actions, policies and requirements having the force of law in the applicable country or jurisdiction. |
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[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
1.3. | Breaching Party shall have the meaning as defined in Section 14.5. |
1.4. | Business Day shall mean a day other than a Saturday, Sunday, or a bank or other public holiday in the United States or Switzerland. |
1.5. | Calendar Quarter shall mean the respective periods of three (3) consecutive calendar months commencing on January 1st, April 1st, July 1st, and October 1st. |
1.6. | Calendar Year shall mean the period of time beginning on January 1st and ending on December 31st. |
1.7. | Change of Control shall mean, with respect to a Party, the occurrence of either of the following transactions (or series of related transactions) involving such Party: |
(a) | merger, consolidation, stock sale or sale or transfer of all or substantially all of the Party’s assets or business pertaining to this Agreement, or other similar transaction or series of transactions (except a sublicense, which is governed by Section 2.6), with another Person, except where, following such transaction (or series of transactions): (i) the Persons who were the beneficial owners of the outstanding voting securities (if any) of such Party immediately prior to such transaction beneficially own, directly or indirectly, at least fifty percent (50%) of the combined voting power of the then-outstanding voting securities entitled to vote generally in the election of directors or similar governing persons of the corporation or other entity (the “Successor”) resulting from such transaction(s), or (ii) at least fifty percent (50%) of the members of the Board of Directors or similar governing body of the Successor were members of the Board of Directors of such Party at the time of the execution of the initial agreement(s) providing for such transaction(s); or |
(b) | any transaction or series of related transactions in which any Person or group of related Persons acquires beneficial ownership of securities of the Party representing more than fifty percent (50%) of the combined voting power of the then-outstanding securities of such Party, it being understood that any sale of such beneficial ownership of securities of such Party to more than one Third Party as part of a financing transaction of such Party shall not constitute a Change of Control transaction; provided, that such sale or beneficial ownership of securities is in connection with the sale of securities (public offering or private placement) under the Securities Act of 1933, as amended and/or the Securities and Exchange Act of 1934, as amended. |
1.8. | Claims shall have the meaning as defined in Section 13.1. |
1.9. | Clinical Product shall mean any and all pharmaceutical products with any kinds of strength, dosage form, and formulations containing the Compound as an active pharmaceutical ingredient, either alone or in combination with one or more other active pharmaceutical ingredient(s), for use only in Clinical Trials. |
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[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
1.10. | Clinical Trial shall mean a Phase I Clinical Trial, Phase II Clinical Trial, Phase III Clinical Trial, Phase IIIb Clinical Trial and/or a “Phase IV” post-approval clinical trial. |
1.11. | [***] |
1.12. | Combination Product shall mean a Licensed Product which includes one or more active ingredient(s) other than the Licensed Compound, in combination with the Licensed Compound. All references to Licensed Product in this Agreement shall be deemed to include Combination Product, including a fixed-dose combination product. All references to Licensed Product in this Agreement shall be deemed to include Combination Product, except as provided in the definition of Net Sales. |
1.13. | Commercialize or Commercialization shall mean all activities carried out in the commercialization of a Licensed Product, including distributing (including, without limitation, importing, exporting, transporting, customs clearance, warehousing, invoicing, handling and delivering the Licensed Product to customers), advertising, promoting, marketing, using and selling the Licensed Product, and booking sales, as applicable. |
1.14. | Commercially Reasonable Efforts shall mean, with respect to the efforts to be expended by a Party and its Affiliates with respect to any objective, reasonable, good faith efforts to accomplish such objective as such Party would normally use to accomplish a similar objective under similar circumstances, with respect to a product at a similar stage in its development or product life and of similar market potential taking into account [***]. Commercially Reasonable Efforts shall be determined on a market-by-market and indication-by-indication basis for a particular product, and it is anticipated that the level of effort will change over time, reflecting changes in the status of the product and the market(s) involved. Notwithstanding the foregoing, Urovant shall not be (i) obligated to continue the Development of, seek the Regulatory Approval of, or Commercialize the Licensed Product if, in its reasonable opinion, it is unsafe for administration to humans, or otherwise inconsistent with Applicable Laws; and (ii) entitled to reduce the effort it expends relating to the Licensed Product in the Field to a level that does not meet the foregoing requirements because it is researching, Developing, or Marketing a product other than the Licensed Product for use in the Initial Field. |
1.15. | Competing Product shall mean [***]. |
1.16. | Compound shall mean the chemical compound identified as [***] as represented by the chemical structure as shown in Schedule 1.16. |
1.17. | Confidential Information shall mean (i) information not in the public domain that is disclosed by one Party or its Affiliates to the other Party or its Affiliates, including all Merck Know-How, Urovant Know-How, unpublished information relating to the Merck Patent Rights and the Urovant Patent Rights, and all other data and information, not in the public domain, relating to the Licensed Compound, the Clinical Product, the Licensed Product, or the business, marketing, promotion, affairs, research and development activities, results of clinical studies, national and multinational regulatory proceedings |
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[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
and affairs, finances, Manufacturing, plans, contractual relationships and operations of either Party or their Affiliates which is disclosed or provided by or on behalf of one Party to the other Party in connection with this Agreement and (ii) the terms and conditions contained in this Agreement that are not in the public domain. |
1.18. | Control shall mean, with respect to any item of the Patent Rights, Know-How, information, data or other intellectual property rights, the possession by a Party, or, where applicable, its Affiliates, its licensee or its Sublicensee, of the power and authority, whether by ownership, license, or other authorization, to grant and authorize access to, or a license or a sublicense of such item, without violating the terms of any agreement or other arrangement with any Third Party existing at the time such Party, its Affiliate, its licensee or its Sublicensee would be required hereunder to grant the other Party such access, license or sublicense. |
1.19. | Develop or Development shall mean the conduct of any and all non-clinical and clinical research and development, including, among other things: drug discovery, toxicology studies, DMPK studies and other non-clinical efforts, statistical analysis, the design and conduct of any Clinical Trials, formulation, regulatory activities including applying for and obtaining Marketing Authorization, with respect to the Licensed Compound and/or the Licensed Product in the Field, that are reasonably required or useful to obtain or maintain any Regulatory Approvals of the Licensed Compound and/or the Licensed Product in the Field in the Territory. |
1.20. | Development Plan shall have the meaning as defined in Section 4.1. |
1.21. | Development Report shall have the meaning as defined in Section 4.1. |
1.22. | Effective Date shall mean the date set forth in the first paragraph of this Agreement. |
1.23. | EMA shall mean the European Medicines Agency or any successor agency with responsibility for regulating the development, manufacture and sale of human pharmaceutical products in the European Union. |
1.24. | Enforceable Claim shall mean a claim of an issued and unexpired patent within the Merck Patent Rights (i) which, absent the rights and licenses granted by Merck to Urovant under this Agreement, would be infringed by the Development, Manufacture, filing and obtaining Regulatory Approvals, or Commercialization of the Licensed Compound and/or the Licensed Product by Urovant, its Affiliates or Sublicensees, such infringement to include, where applicable, contributory infringement and infringement by inducement and (ii) which has not been permanently revoked or held unenforceable or invalid by a decision of a court or other Governmental Agency of competent jurisdiction, unappealable or from which an appeal was not filed within the time allowed for appeal, and which has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise. |
1.25. | [***]. |
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[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
1.26. | European Union shall mean the member states existing as of the relevant point in time. For purposes of this Agreement, the United Kingdom shall be considered part of the European Union, irrespective of whether the United Kingdom is a member of the European Union. |
1.27. | Excluded Claim shall have the meaning as defined in Section 17.6(b). |
1.28. | FDA shall mean the United States Food and Drug Administration or any successor agency thereto. |
1.29. | Field shall mean the treatment, prevention, cure, or control of any human disease, disorder, illness, or condition, including without limitation, the Initial Field. |
1.30. | [***]. |
1.31. | [***]. |
1.32. | First Commercial Sale shall mean, with respect to a given Licensed Product in a given country in the Territory, the first sale of commercial quantities of a Licensed Product in such country to a Third Party on arm’s length terms by Urovant, its Affiliate or Sublicensee for use in the Field after the receipt of Marketing Authorization in such country. Sales for test marketing, sampling and promotional uses, Clinical Trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale. |
1.33. | [***]. |
1.34. | Fiscal Year shall mean the period of time beginning on April 1 and ending on March 31. |
1.35. | Follow-up Period shall have the meaning as defined in Section 3.1(d). |
1.36. | [***]. |
1.37. | Generic Product shall mean, with respect to a Licensed Product, any product(s) containing the Licensed Compound for which marketing approval is obtained by abbreviated New Drug Application (ANDA) or other abbreviated process not requiring the filing of a complete NDA in the United States or a corresponding application in any other country, other than (i) a Licensed Product introduced in such country by Urovant, its Affiliates or its Sublicensees; or (ii) a Licensed Product introduced by a Third Party through a contractual relationship with Urovant, its Affiliates or its Sublicensees. |
1.38. | Governmental Agency shall mean any national, regional, municipal, country, or other governmental, quasi-governmental, administrative or regulatory agency, body or other similar entity in a given jurisdiction, including the FDA and EMA, in the Territory that is responsible for granting any Regulatory Approvals. |
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[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
1.39. | IND shall mean an investigational new drug application with respect to the Licensed Product filed with the FDA for beginning Clinical Trials in humans, or any comparable application filed with the Regulatory Authorities of a country other than the United States prior to beginning Clinical Trials in humans in that country, as well as all supplements or amendments to such filings. |
1.40. | Initial Field shall mean the treatment in humans of overactive bladder and/or incontinence. |
1.41. | Initial Payment shall have the meaning as defined in Section 6.1. |
1.42. | Inventions shall mean intellectual property which is novel, non-obvious and useful as defined by the US patent law or the equivalent legal concepts as defined in any other patent-granting jurisdiction. |
1.43. | Know-How Product shall have the meaning as defined in Section 6.3(b). |
1.44. | LIBOR shall mean the London Inter-Bank Offering Rate. |
1.45. | Licensee shall mean Kyorin Pharmaceutical Co., Ltd. and its Affiliates and sublicensees. |
1.46. | Licensee Territory means those countries and territories, as set forth on Schedule 1.46, for which Merck has granted Licensee an exclusive license to Commercialize the Licensed Compound. |
1.47. | Licensed Compound shall mean (a) the Compound; (b) that certain back-up compound to the Compound referred to internally by Merck as [***], as represented by the chemical structure as shown in Schedule 1.47 and covered by one or more claims of the Merck Patent Rights set forth on Schedule 1.55 (Merck Patent Rights); (c) any and all biologically active metabolites of any of the compounds described in the foregoing clauses (a) and (b); or (d) any and all prodrugs of any of the compounds described in clauses (a), (b), or (c); and/or (e) any and all salts, esters, acid forms, base forms, stereoisomers, racemates, tautomers, polymorphs, solvates, anhydrides, hydrates and crystalline forms of any of the compounds described in the foregoing clauses (a), (b), (c) or (d). |
1.48. | Licensed Product shall mean any and all pharmaceutical products with any kinds of strength, dosage form, and formulations containing the Licensed Compound as an active pharmaceutical ingredient, either alone or in combination with one or more other active pharmaceutical ingredient(s), for final sale in the Field in the Territory. |
1.49. | Licensed Product Trademarks shall have the meaning as defined in Article 10. |
1.50. | Losses shall have the meaning as defined in Section 13.1. |
1.51. | Manufacture shall mean all activities by or on behalf of a Party related to the manufacturing of a pharmaceutical product, or any ingredient thereof, including but not |
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[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
limited to test method development and stability testing, formulation, process development, manufacturing for use in non-clinical or clinical studies, manufacturing scale-up, manufacturing Licensed Compound or Licensed Product for Development or Commercialization, labeling, filling, processing, quality assurance/quality control development, quality control testing (including in-process release and stability testing), packaging, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, and regulatory activities related to all of the foregoing. |
1.52. | Marketing Authorization shall mean, with respect to each country in the Territory, the receipt of all approvals from the relevant Regulatory Authority necessary to market and sell a Licensed Product in any country (including without limitation all applicable price approvals even if not legally required to sell Licensed Product in a country). |
1.53. | Merck Indemnitees shall have the meaning as defined in Section 13.2. |
1.54. | Merck Intellectual Property shall mean Merck Patent Rights, Merck Know-How and any trademarks, copyrights, and trade names relating to the Licensed Compound and/or the Licensed Product that Merck and/or any of its Affiliates Controls as of the Effective Date, and/or will Control during the Term. |
1.55. | Merck Patent Rights shall mean any and all Patent Rights which are Controlled by Merck or any of its Affiliates as of the Effective Date or at any time during the Term and which (a) claim or cover any Licensed Compound and/or Licensed Product, or the development, manufacture, commercialization, use or sale thereof, or (b) claim or cover any Merck Know-How. The Merck Patent Rights existing and enforceable in the Territory as of the Effective Date shall be listed in Schedule 1.55 hereto, which shall be, from time to time during the Term, updated to reflect the most current status of the Merck Patent Rights. |
1.57. | Milestone Payments shall have the meaning as defined in Section 6.2. |
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[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
1.58. | NDA shall mean a New Drug Application, Biologics License Application, Worldwide Marketing Application, Marketing Application Authorization, filing pursuant to Section 510(k) of the United States Food & Drug Act, or similar application or submission for Marketing Authorization of a product filed with a Governmental Agency to obtain marketing approval for a biological, pharmaceutical or diagnostic product in that country or in that group of countries. |
1.59. | Net Sales shall mean the gross invoice price (not including value added taxes, sales taxes, or similar taxes) of end-market sales of Licensed Product sold by Urovant or its Affiliates to the first Third Party less deductions in accordance with US Generally Accepted Accounting Principles and/or International Financial Reporting Standards accounting standards (to the extent not otherwise taken into account) for: |
(a) | [***] |
Net Sales shall not include any payments among Urovant, its Affiliates and Sublicensees.
With respect to sales of Combination Products, Net Sales for any such Combination Product in a particular country in the applicable Calendar Quarter shall be calculated as follows:
(w) | [***] |
1.60. | Non-breaching Party shall have the meaning as defined in Section 14.5. |
1.61. | Other Claim shall have the meaning as defined in Section 13.3. |
1.62. | Party shall mean each of Merck or Urovant, as applicable and “Parties” shall mean both of Merck and Urovant. |
1.63. | Patent Rights shall mean any and all (a) patents or patent applications in the Territory (which for the purposes of this Agreement shall be deemed to include certificates of invention and applications for certificates of invention); (b) any and all divisionals and continuations, continuations-in-part, reissues, renewals, substitutions, registrations, re-examinations, revalidations, extensions, supplementary protection certificates, pediatric exclusivity periods, and the like of any such patents and patent applications and foreign equivalents thereof. |
1.64. | Phase III Clinical Trial shall mean a clinical trial of a Licensed Product in human patients, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use, (b) to define warnings, precautions and adverse reactions that are associated with such Licensed Product in the dosage range to be prescribed, (c) to be, either by itself or together with one or more other Clinical Trials having a comparable design and size, the final human Clinical Trial in support of Regulatory Approval of a Marketing Authorization of such Licensed Product, and (d) consistent with 21 U.S. CFR § 312.21(c). |
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[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
1.65. | Regulatory Approvals shall mean any United States federal, state, or local government, or any foreign government, or political subdivision thereof, or any multinational organization, authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof), or any governmental arbitrator or arbitral body with responsibility for granting licenses or approvals, including Marketing Authorizations, necessary for the marketing and sale of the Licensed Compound and/or the Licensed Product in the Field in the Territory. |
1.66. | Regulatory Documentation shall mean all regulatory applications, registrations, licenses, authorizations and approvals (including all Marketing Authorizations), all correspondence submitted to or received from Governmental Agencies (including minutes and official contact reports relating to any communications with any Governmental Agency), and all reports and documentation in connection with clinical studies and tests (including study reports and study protocols, and copies of all interim study analysis), and all data contained in any of the foregoing, including all INDs, manufacturing data, drug master files, clinical data, adverse event files and complaint files, in each case related to any Licensed Compound or Licensed Product. In all cases, such documentation as provided for in this Section 1.66, shall be provided “as is”, Merck shall be under no obligation to finalize or complete any study reports, study analysis or other interim reports. |
1.67. | Required Third Party Agreement shall have the meaning as defined in Section 6.5. |
1.68. | [***] |
1.69. | Royalty Term shall mean, with respect to a given Licensed Product in a given country in the Territory, the later of (a) the expiration of the last to expire Enforceable Claim of a Merck Patent Right covering such Licensed Product (or the Licensed Compound contained in, or comprising, such Licensed Product) in such country; (b) expiration of any data or market exclusivity conveyed by a Governmental Agency and associated with the Marketing Authorization or equivalent of the Licensed Product in such country; or (c) fifteen (15) years from First Commercial Sale of such Licensed Product in such country. |
1.70. | Safety Termination shall have the meaning as defined in Section 14.3. |
1.71. | SEC shall mean the U.S. Securities and Exchange Commission. |
1.72. | [***]. |
1.73. | Specifications shall mean the specifications and quality control procedures as developed by Merck for the Clinical Product. |
1.74. | Sublicensee shall mean any Third Party to whom Urovant has granted a sublicense of any of the rights granted to it under Sections 2.1 and 2.2 pursuant to Section 2.6. |
1.75. | Sublicense Agreement shall have the meaning as defined in Section 2.6. |
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[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
1.76. | Taxes shall have the meaning as defined in Section 6.10. |
1.77. | Term shall have the meaning as defined in Section 14.1. |
1.78. | Territory shall mean worldwide excluding the Licensee Territory. |
1.79. | Third Party shall mean a person or entity other than Merck or Urovant, or any of their Affiliates. |
1.80. | Third Party Patent Rights shall have the meaning as defined in Section 9.8(a). |
1.81. | [***]. |
1.82. | Transfer Completion Notice shall have the meaning as defined in Section 3.1(c). |
1.83. | Transfer Completion Notice Date shall have the meaning as defined in Section 3.1(c). |
1.84. | Transfer Confirmation Notice shall have the meaning as defined in Section 3.1(c). |
1.85. | Urovant Indemnitees shall have the meaning as defined in Section 13.1. |
1.86. | Urovant Intellectual Property shall mean Urovant Patent Rights and Urovant Know-How relating to the Licensed Compound and/or the Licensed Product that Urovant and/or any of its Affiliates Controls during the Term. |
1.87. | Urovant Inventions shall mean the Inventions pertaining to the Licensed Compound and the Licensed Product which are conceived and/or reduced to practice solely by Urovant and/or any of its Affiliates (excluding any Inventions conceived and/or reduced to practice by an Affiliate that becomes an Affiliate through a Change of Control of Urovant, and existing as of the date of the closing of such Change of Control) as of the effective date of any license to Merck as provided under Section 15.1, as defined by the U.S. Patent Law, and which Urovant and/or any of such Affiliate Controls during the Term. |
1.88. | Urovant Know-How shall mean know-how, information and data necessary or reasonably useful for (a) the Development and/or Manufacture of the Licensed Compound and/or the Licensed Product in the Field, in the form in which such Licensed Compound or Licensed Products exist as of the effective date of any license thereto to Merck as provided under Section 15.1; (b) obtaining the Regulatory Approvals of the Licensed Compound and/or the Licensed Product in the Field, or (c) the Commercialization of the Licensed Product in the Field, that Urovant and/or any of its Affiliates Controls during the Term. The Urovant Know-How shall include the Urovant Inventions. |
1.89. | Urovant Patent Rights shall mean the Patent Rights claiming the Urovant Inventions. |
1.90. | [***]. |
1.91. | Withholding Party shall have the meaning as defined in Section 6.10. |
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[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
Article 2 License Grants; Scope of Licenses
2.1 | Licensed Grants to Urovant. Subject to the terms and conditions of this Agreement, Merck hereby grants to Urovant, and Urovant hereby accepts during the Term under the Merck Intellectual Property |
(a) | an exclusive (even as to Merck and its Affiliates), royalty-bearing right and license, with a right to grant sublicenses (subject to the restrictions set forth in Section 2.6), to Develop, Manufacture, have Manufactured, offer to sell, sell and otherwise Commercialize the Licensed Compound and/or the Licensed Product in the Field in the Territory, including the right to obtain and maintain the Regulatory Approvals in the Territory. |
(b) | a non-exclusive, sublicensable right and license to: (i) Develop the Licensed Compound and Licensed Product in the Licensee Territory solely for the purpose of Developing, Manufacturing, and Commercializing such Licensed Products in the Field in the Territory, and (ii) Manufacture the Licensed Compound and Licensed Product in the Licensee Territory solely for use in the Development or Commercialization of the Licensed Product in the Territory. |
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[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
2.5 | Urovant’s Responsibilities. Urovant shall be responsible at its own expense for, and shall control, all aspects of, the Development, registration, Manufacture and Commercialization of the Licensed Compound and the Licensed Product in the Field in the Territory. Urovant shall be responsible at its own expense for, and shall control, all aspects of, the Development and Manufacture of the Licensed Compound and the Licensed Product in the Field in the Licensee Territory as permitted under this Agreement. |
2.6 | Sublicenses. Urovant may grant a sublicense of any of the rights and licenses granted to it by Merck under Sections 2.1 and 2.2 to its Affiliates or any Third Party without obtaining Merck’s prior written consent; [***]. Each agreement under which Urovant grants a sublicense under the license set forth in Sections 2.1 and 2.2 (“Sublicense Agreement”) shall be consistent with the terms and conditions of this Agreement. Urovant shall use commercially reasonable efforts to (a) procure the performance by any Sublicensee of the terms of each applicable Sublicense Agreement, and (b) ensure that any Sublicensee will comply with the applicable terms and conditions of this Agreement, including compliance with all Applicable Laws and ethical business practices. Urovant hereby guarantees the performance of its Sublicensees that are party to a Sublicense Agreement as permitted herein, and the grant of any such sublicense will not relieve Urovant of its obligations under this Agreement, except to the extent such obligations are satisfactorily performed by such Sublicensee. |
Article 3 Transfer of Merck Know-How and Compound, and Licensee Data
3.1 | Merck Know-How and Compound. As soon as practicably possible after the Effective Date but in no event later than ninety (90) days after the Effective Date, Merck will (i) provide Urovant with Merck Know-How listed in Schedule 1.56; and (ii) deliver to Urovant the Compound as set forth on Schedule 3.1. |
(a) | Transfer of Materials. Merck shall make available for a one-time transfer to Urovant, at no cost, in a mutually agreed manner, the quantities of Compound and available working standards for the Compound, as set forth on Schedule 3.1. Such inventory shall only be used in preclinical and clinical work in accordance with the license grant in Section 2.1 and shall not be used for commercial purposes. For avoidance of doubt, any amounts of Compound transferred by Merck to Urovant under this Section 3.1 shall not be used by Urovant to Manufacture Licensed Product other than for use in preclinical and clinical work. Merck shall have no further obligation to make any further Compound inventory available to Urovant. Urovant acknowledges and agrees that, prior to use of the transferred Compound for preclinical and clinical work, Urovant shall conduct stability testing and testing to determine whether such Compound meets the Specifications, at Urovant’s own expense. Merck shall provide to Urovant the current certificate of analysis for the Compound that |
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exists as of the Effective Date, but shall not be obligated to re-test any batches of expired Compound. For the avoidance of doubt, Merck makes no representation or warranty that such Compound meets any of the Specifications, and any use of such Compound by Urovant shall not be subject to any claim for indemnification by Urovant under Section 13.1. |
(b) | Shipping. Urovant shall be responsible for shipping cost from current warehousing location(s) where the Compound resides, and any applicable customs/duties. Applicable customs and duties will be determined based on a valuation of the quantity of the Compound performed by Merck and agreed by Urovant prior to shipping. The risk of loss from any casualty to the Compound, regardless of the cause, shall be transferred to Urovant upon delivery of the Compound to the shipper. In addition, Urovant shall cause the shipper to ensure that the Compound is stored and shipped in conditions that do not adversely effect the Compound’s stability and integrity. |
(c) | Transfer Completion Notice. Merck shall issue to Urovant, in writing, a Transfer Completion Notice upon completion of Merck’s obligations under Section 3.1(a) above (the “Transfer Completion Notice”). Such Transfer Completion Notice shall be issued no later than [***] following the Effective Date (the “Transfer Completion Notice Date”). Urovant shall have [***] Business Days from Transfer Completion Notice Date to send confirmation in writing to Merck that Merck has effectively completed its obligations under Section 3.1(a) (the “Transfer Confirmation Notice”). |
(d) | Technical Support. For a period not to exceed [***] from the receipt by Merck of Urovant’s Transfer Confirmation Notice (the “Follow-up Period”), Merck will provide Urovant with [***] Such technical support may, at Urovant’s request, include, without limitation, the following activities: |
(i) | [***] |
Merck will also make reasonable efforts to provide responses to written questions Urovant may reasonably raise as Urovant initiates process development, and completes and releases registration batches, to the extent that internal resources are available to answer any such written questions. For clarity, however, nothing herein requires Merck to provide assistance beyond the [***] period specified in this Section 3.1(d) (Technical Support).
(e) | Complete Transfer. The Parties acknowledge that Merck shall have completed its contractual obligations under this Agreement with respect to technical support upon the completion of the activities described in this Section 3.1. |
(f) | Transfer of Merck Know-How. Merck shall provide Merck Know-How as described in Schedule 1.56 and the Regulatory Documentation in a single copy |
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[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
in electronic format only. Merck shall be responsible for all costs associated with transfer of Merck Know-How and Regulatory Documentation. For the avoidance of doubt, Merck shall have no obligation to provide the source documentation or any additional data, in any form, other than that provided within the Merck Know-How as listed in Schedule 1.56. |
3.2 | Licensee Data. Merck agrees to use reasonable efforts with Licensee to either (a) seek consent to disclose to Urovant, (b) enter into an agreement, either a three-way agreement between Merck, Licensee and Urovant, or a direct agreement between Licensee and Urovant; in each case of (a) or (b) to allow for Merck to provide to Urovant any data or reports received in final form provided by Licensee after the Effective Date to Merck related to Licensed Compounds, the Clinical Product, Licensed Products in connection with clinical studies, formulation work, manufacturing work, other testing work and regulatory activity; provided, however, in the event that any data or reports of Licensee are required by Urovant to either gain or maintain a Regulatory Approval, Merck shall provide such data or reports to Urovant. Failure of Merck to either obtain consent as described in subsection (a) above or enter into a definitive agreement as described in (b) above shall not be deemed to be a material breach under this Agreement. |
Article 4 Development; Regulatory Approvals and Compliance with Applicable Laws
4.3 |
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applicable Governmental Agency for the Licensed Product in the Field in the Territory. Subject to Section 2.6, Urovant shall be the holder of all Regulatory Approvals for the Licensed Product in the Field in the Territory. For clarity, Merck (and its Affiliates) shall have no right to, and shall not, make any regulatory filings related to any Licensed Compound or Licensed Product or otherwise communicate or interact with any Government Agencies with respect to the Licensed Compounds or Licensed Products. |
5.1 |
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(at its sole cost and expense) use Commercially Reasonable Efforts to Commercialize the Licensed Product, and maximize the value of the Licensed Product in the Field in the Territory during the Term. |
5.5 | Commercialization. Urovant shall give Merck prior written notice of at least [***] days of its intent to file a Marketing Authorization in a specific country or region for the Licensed Product and, at that time, shall further provide Merck with the anticipated date of First Commercial Sale for the Licensed Product in the country of filing. Urovant shall promptly provide Merck with notice of the granting of any Marketing Authorization of Licensed Product. |
5.6 | Section 365(n) of the Bankruptcy Code. All rights and licenses granted under or pursuant to any section of this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code. Each Party shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code or equivalent legislation in any other jurisdiction. Upon the bankruptcy of either Party, the other Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property, which, if not already in its possession, shall be promptly delivered to such other Party, unless the Party in bankruptcy elects to continue, and continues, to perform all of its obligations under this Agreement. |
Article 6 Consideration and Reporting
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(a) | [***] |
(b) | Urovant shall notify Merck in writing within [***] days after the achievement of each such milestone event by Urovant, its Affiliates or a Sublicensee giving rise to a payment obligation under this Section 6.2 and Urovant shall pay Merck the indicated amount no later than [***] days after receipt of an invoice from Merck. For clarity, each of the milestone payments set forth in this Section 6.2 shall be made only once and upon the first occurrence of such event, regardless of the number of Licensed Products that achieve the applicable milestone event. Notwithstanding the foregoing, in the event that the approval of the Marketing Authorization which would otherwise trigger [***] |
(i) | [***] |
6.4 | [***] |
6.5 |
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Licensed Product would infringe such Third Party Patent Rights in such country (each, a “Required Third Party Agreement”) and (b) makes royalty payments under such Required Third Party Agreement, then the royalties due to Merck pursuant to Section 6.3(a) or (b), as the case may be, above for such affected Licensed Product in such country may be reduced by [***] of the amount of the royalty payments required under such Required Third Party Agreements with respect to such country; provided, that any such reductions shall in no event reduce the royalty for any such Licensed Product in any such country payable pursuant to Section 6.3 by more than [***] of the amount otherwise owed at such time under Section 6.3(a) or (b), as the case may be. |
6.7 | Reports; Payment of Royalty; Payment Exchange Rate and Currency Conversion |
(a) | Royalties Paid Quarterly. Within sixty (60) calendar days following the end of each Calendar Quarter, following the First Commercial Sale of a Licensed Product, Licensee shall furnish to Merck a written report for the Calendar Quarter showing the Net Sales of each Licensed Product sold by Licensee, its Affiliates and its Sublicensees in the Territory during such Calendar Quarter and the royalties payable under this Agreement for such Calendar Quarter. Such written report shall include (and in the case of Sublicensees, where obtainable from them) the gross sales of each Licensed Product in the territory, an itemized calculation of any deductions taken from such gross sales to arrive at Net Sales for the applicable Calendar Quarter, and the calculation of the amount of royalty payment due on such Net Sales. Simultaneously with the submission of the written report, Licensee shall pay to Merck the royalty due for such Calendar Quarter calculated in accordance with this Agreement. |
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6.8 | Maintenance of Records; Audits |
(b) | Underpayments/Overpayments. If such independent certified public accounting firm correctly concludes that additional royalties were owed during such period, Urovant shall pay such additional royalties within thirty (30) days of the date Merck delivers to Urovant such accounting firm’s written report. If such underpayment exceeds both [***], then the reasonable fees charged by such independent certified public accounting firm for the work associated with such underpayment audit shall be paid by Urovant. For clarity, in all other circumstances the fees charged by such independent certified public accounting firm for the work associated with such underpayment audit shall be paid by Merck. Any overpayments by Urovant will be credited against future royalty obligations owed under Section 6.3. |
(d) | Confidentiality. Merck shall treat all financial information subject to review under this Section 6.8, or under any Sublicense Agreement, in accordance with the confidentiality provisions of Article 11 of this Agreement, and shall cause its independent certified public accounting firm to enter into an acceptable confidentiality agreement with Urovant obligating such independent certified public accounting firm to retain all such financial information in confidence pursuant to such confidentiality agreement. |
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6.9 | Late Payments. Any amount owed by Urovant to Merck under this Agreement that is not paid within the applicable time period set forth herein shall accrue interest at the rate of [***]. |
Urovant shall maintain, or cause its Sublicensees to maintain, an effective system for the collection, review, assessment, tracking and regulatory submission of the product quality
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complaint and recall of the Licensed Product in the Territory during the Term. In the event that any Governmental Agency requests Urovant, its Affiliates or Sublicensees to recall the Licensed Product in the Territory, or Urovant believes any event may require the necessity of initiating a recall of the Licensed Product in the Territory, Urovant shall notify Merck of such request or event within one (1) business day after Urovant becomes aware of the request or the event. The Parties shall consult prior to initiating a recall or withdrawal of the Licensed Product in the Territory; provided, however, that the final decision as to whether to recall or withdraw the Licensed Product in the Territory shall be made by Urovant. Urovant shall be responsible for conducting such recalls or taking such other necessary remedial actions at its sole expense.
Article 9 Intellectual Property
9.1 | Ownership of Urovant Intellectual Property. Merck and Urovant hereby acknowledge that, as between Merck and Urovant, |
(a) | All rights, title and interest in or to the Merck Intellectual Property shall remain in the possession or Control of Merck, and Urovant shall acquire no rights, title or interest whatsoever in or to the Merck Intellectual Property, except as specifically provided in this Agreement, including the licenses granted herein. Without limiting the generality of this Section 9.1(a), Urovant shall not utilize any Merck Intellectual Property for any purpose whatsoever, except as specifically authorized in this Agreement. |
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(b) | All rights, title and interest in or to the Urovant Intellectual Property shall remain in the possession or Control of Urovant, and Merck shall acquire no rights, title or interest whatsoever in or to the Urovant Intellectual Property. Without limiting the generality of this Section 9.1(b), Merck shall not utilize any Urovant Intellectual Property for any purpose whatsoever, except as specifically authorized in this Agreement. |
9.6 | Interference, Derivation, Opposition, Reissue, Reexamination and Post Grant Review Proceedings. Any Party shall, within [***] business days of learning of any |
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request for, or filing or declaration of, any interference, derivation, opposition, reexamination, or post grant review (or similar administrative proceedings) or notice from a Third Party indicating the possibility of any such action relating to any Merck Patent Right, inform the other Party of such event. Urovant shall have the first right to control the defense of such action at its own expense, and shall permit Merck to participate in the proceeding to the extent permissible under Applicable Laws, and to be represented by its own counsel in such proceeding, at Merck’s expense. If Urovant decides that it does not wish to defend against such action, then Merck will have a backup right to assume defense of such action at Merck’s expense. Urovant shall not initiate any interference, derivation, reissue, or reexamination proceeding (or similar administrative proceedings) relating to any Merck Patent Right, or seek correction of a patent within the Merck Patent Rights, without the prior written consent of Merck, which consent shall not be unreasonably withheld, delayed or conditioned. In connection with any interference, derivation, opposition, reissue, reexamination, or post grant review proceeding (or similar administrative proceedings) or correction relating to Merck Patent Rights, Merck and Urovant will cooperate fully and will provide each other with any information or assistance that either may reasonably request. Urovant shall keep Merck reasonably informed of developments in any such action or proceeding, including, to the extent permissible by law, the status of any settlement negotiations and the terms of any offer related thereto. Urovant agrees to consult with Merck, and will obtain Merck’s consent prior to entering in any settlement agreement, such consent not be unreasonably withheld, conditioned or delayed. |
9.7 | Infringement by Third Party |
(a) | Each Party shall promptly furnish the other Party with written notice of any and all existing, alleged, or threatened infringements and other unauthorized uses by any Third Party of any of the Merck Intellectual Property that come to the attention of such Party during the Term, and will provide all information in such Party’s possession related to such infringement. |
Urovant shall have the first right to take all actions in the courts, administrative agencies or otherwise to prevent or enjoin any and all such infringements and other unauthorized uses of the Merck Intellectual Property, and may retain any settlement payment, award, damage or other remuneration obtained through such actions (it being understood that any such award, after deduction of expenses, shall be deemed Net Sales in the period in which received), and Merck shall take no action with respect to any such infringement or other unauthorized use of the Merck Intellectual Property outside the scope of this Section 9.7(a); provided, however, that Urovant shall first consult with and seek Merck’s consent prior to entering into any settlement agreement in connection with Merck’s Intellectual Property, such consent not be unreasonably withheld, conditioned or delayed.
Merck shall provide Urovant, at Urovant’s expense, with such assistance and access to information as Urovant shall reasonably request in connection with any actions to prevent or enjoin any such infringement or other unauthorized use of any of the Merck Intellectual Property or the Urovant Intellectual Property, as the case may be.
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(b) | If Urovant does not take action in order to prevent or enjoin any and all such infringements and other unauthorized uses of the Merck Intellectual Property within thirty (30) days after receipt of the information concerning the infringement or other unauthorized use, Merck shall, at its own expense, have the right, but not obligation, to take all actions to prevent or enjoin such infringement and other unauthorized uses and may retain any settlement payment, award, damage or other remuneration obtained by such actions. |
9.8 | Infringement of Third Party Patent Rights |
(a) | In the event that a Third Party institutes an action, suit or proceeding against Merck, Urovant, or their respective Affiliates, alleging that (i) the Development and/or Commercialization of the Licensed Product in the Field infringes one (1) or more Patent Rights or other intellectual property rights held by such Third Party or (ii) the Manufacturing of the Licensed Product infringes one (1) or more Patent Rights or other intellectual property rights held by such Third Party (in each case of (i) and (ii) “Third Party Patent Rights”), then Urovant shall have the right to assume direction and control of the defense of such action, suit or proceeding, including the right to settle any such action, suit or proceeding at its sole cost and expense. Urovant shall not settle any such action, suit or proceeding in a manner that would impose any restrictions on its ability to Develop and Commercialize the Licensed Product in the Field in the Territory without the prior written consent of Merck, which consent shall not be unreasonably withheld, conditioned or delayed. |
(b) | If Urovant fails to assume such direction and control within the earlier of (i) [***] calendar days after service of the complaint in such action, suit or proceeding or (ii) [***] calendar days prior to any date any answer or other response is due in connection with any such action, suit, or proceeding (after any permitted extensions) or fails to diligently continue such direction and control thereafter, Merck shall have the right to assume direction and control thereto, at its cost and expense. [***]. |
(c) | If Urovant assumes direction and control of the defense of such Third Party Patent Rights claim, if Merck is a named defendant in such action, Merck shall have the right to participate fully in all aspects of the litigation, to the extent permissible by law, at its own cost and expense. |
9.9 |
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Merck’s own expense, take such actions to attempt to reinstate such Merck Patent Rights; provided, however, that in the event such abandonment or lapse of such Merck Patent Rights was a result of Urovant’s failure to provide proper notice to Merck pursuant to Section 9.3, and Merck wishes to reinstate such Merck Patent Rights, then Urovant shall bear the cost of the reinstatement. |
9.10 | No Challenge of Validity of Patent. Urovant hereby agrees that in the event that it, or any of its Affiliates, challenges the validity of any patent application or patent within the Merck Patent Rights, Merck may, in its sole discretion, terminate Urovant’s license under this Agreement to such patent application or patent. Urovant also agrees that it shall include in any sublicense agreement a provision that requires that, upon challenge of the Merck Patent Rights by such Sublicensee, Urovant shall have the right to terminate such sublicense. |
Article 10 Licensed Product Trademark
Trademark Choice. Urovant shall have the right to market the Licensed Products in the Field in the Territory under the trademarks of its choice (any such trademarks, the “Licensed Product Trademarks”), and all goodwill associated therewith will inure to the benefit of Urovant. Upon termination of this Agreement, upon the request of Merck, Urovant shall assign, transfer and convey all of its rights in the Licensed Product Trademarks, domain names containing such Licensed Product Trademarks, to Merck or its designated assignee; provided, however, that this provision shall not apply to any trademarks including the name of Urovant or any of its Affiliates.
Article 11 Confidentiality and Publication
(a) | is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by the receiving Party’s business records; |
(b) | is properly in the public domain by use and/or publication before its receipt from the disclosing Party, or thereafter enters the public domain through no fault of the receiving Party; |
(c) | is subsequently disclosed to the receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or |
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(d) | is developed by the receiving Party independently of the Confidential Information received from the disclosing Party, as documented by the receiving Party’s business records. |
(a) | to be disclosed by Urovant to its Affiliates, Sublicensees, agents, consultants, and/or other Third Parties in the ordinary course of business in accordance with this Agreement (including the exercise of licenses granted to Merck hereunder), either inside or outside the Territory for the Development or Manufacture of the Licensed Compounds and/or the Licensed Products inside and outside the Territory, and/or the Commercialization of the Licensed Products in the Territory (or for such persons to determine their interest in performing such activities) in accordance with this Agreement, on the condition that such Affiliates and/or Third Parties agree to be bound by the confidentiality and non-use obligations contained in this Agreement; provided, that the term of confidentiality for such Affiliates and/or Third Parties shall be no less than [***]. |
(b) | to be disclosed by Merck or its Affiliates to the Licensee, or Licensee’s agents, consultants, and/or sublicensees for the Development of the Licensed Compound and/or the Licensed Product inside and outside the Territory, Manufacturing of the Licensed Compound and/or the Licensed Product inside and outside the Licensee Territory and/or the Commercialization of the Licensed Product outside the Licensee Territory (or for such persons to determine their interest in performing such activities) in accordance with this Agreement, on the condition that Licensee and/or such Third Parties agree to be bound by the confidentiality and non-use obligations contained in this Agreement; provided, that that the term of confidentiality for Licensee, such Affiliates and/or Third Parties shall be no less than [***]; and |
(c) | to be disclosed to governmental or other regulatory agencies in order to obtain patents or to gain or maintain approval to conduct clinical studies or to market the Licensed Products, but such disclosure may be only to the extent reasonably necessary to obtain such patents or authorizations, and all reasonable steps shall be taken to protect the confidentiality of such Confidential Information. |
11.3 |
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administrative process or Applicable Laws shall, except where impracticable or legally impossible, take all steps reasonably necessary, including without limitation obtaining an order of confidentiality, to ensure the continued confidential treatment of such Confidential Information. Both Parties shall require their respective directors, officers and employees to whom the Confidential Information is disclosed to undertake confidentiality and non-use obligations consistent with the terms of this provision. |
11.7 |
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information related to the existence of this Agreement or the terms or conditions herein, except (a) on the advice of its counsel as required by law (e.g., any SEC filings and disclosures); provided, that the disclosing Party has consulted with the other Party to the extent feasible prior to such disclosure with respect to the substance of the disclosure; or (b) as consented to in advance by the other Party in writing. The Parties shall agree on a form of initial press release that may be used by either Party on an ongoing basis to describe this Agreement. Licensee shall provide Merck with reasonable advance written notice of any press release or other public disclosure of the results of any of its work on Licensed Compounds or Licensed Products under this Agreement, to the extent practical. Disclosure of Confidential Information either for which consent has previously been obtained (including the contents of any press release set forth in this Section 11.7) or which has previously been disclosed publicly will not require additional advance approval. |
Article 12 Representations, Warranties and Liabilities
12.1 | Merck hereby represents and warrants to Urovant that: |
(a) | it has the full right, power and authority to enter into this Agreement, to grant the rights and licenses granted under Article 2, and the execution and delivery by Merck of this Agreement and the performance by Merck of the transactions contemplated hereby have been duly authorized by all necessary corporate actions of Merck; |
(b) | this Agreement constitutes legal, valid and binding obligations of Merck, enforceable against Merck in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally; |
(c) | the execution, delivery and performance of this Agreement do not and will not conflict with or result in a breach of or constitute a default under any indenture, instrument, agreement or documents to which Merck or its Affiliates is a party or by which any of its assets or properties are bound; |
(d) | the Merck Patent Rights set forth on Schedule 1.55 constitute all intellectual property owned or otherwise controlled (through license or otherwise) by Merck (or any of its Affiliates) that is necessary to Develop, Manufacture, sell or use the Compound, the Merck Intellectual Property exists, and to the best of its knowledge as of the Effective Date, the Merck Patent Rights are not invalid or unenforceable in the Territory, in whole or in part; |
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(e) | it has not licensed, assigned, transferred, conveyed or otherwise encumbered to any Third Party its right, title and interest in the Merck Intellectual Property in any manner inconsistent with the rights and licenses granted to Urovant under this Agreement, and will not license, assign, transfer, convey or otherwise encumber to any Third Party its right, title and interest in the Merck Intellectual Property in any manner inconsistent with the rights and licenses granted to Urovant under this Agreement; |
(f) | it, or its Affiliates, has the right to grant exclusive rights and licenses under the Merck Patent Rights in the Territory in the manner set forth in Section 2.1; |
(g) | it is the sole and exclusive owner of the Merck Intellectual Property, and to the best of its knowledge as of the Effective Date, the Merck Intellectual Property in the Territory is free and clear of any liens, charges and encumbrances, and no other person, corporate or other private entity, or governmental entity or subdivision thereof, has or shall have any claim of ownership or other rights whatsoever with respect to the Merck Intellectual Property in the Territory; |
(h) | to the best of its knowledge as of the Effective Date, there are no claims, judgments or settlements against or owed by Merck, or pending or threatened claims or litigation, relating to the Merck Intellectual Property in the Territory; |
(i) | to the best of Merck’s knowledge, there is no unauthorized use, infringement or misappropriation of any Merck Intellectual Property; |
(j) | to the best of its knowledge as of the Effective Date, there are no Patent Rights, trademark rights, trade secrets or other intellectual property rights owned or controlled by a Third Party that would be infringed or misappropriated by the Manufacture, promotion, marketing, sale, offer for sale, import, export or use of the Licensed Compound and/or the Licensed Product in the Territory, and neither Merck nor any of its Affiliates has received any written claim relating to any such infringement or misappropriation or of any need for a license; |
(k) | it has the right to disclose to Urovant the Merck Intellectual Property; and |
(l) | the license agreement with Licensee is in full force and effect. |
12.2 | Urovant hereby represents and warrants to Merck that: |
(a) | it has the full right, power and authority to enter into this Agreement, to grant the rights and licenses granted under Article 2, and execution and delivery by Urovant of this Agreement and the performance by Urovant of the transactions contemplated hereby have been duly authorized by all necessary corporate actions of Urovant; |
(b) | this Agreement constitutes legal, valid and binding obligations of Urovant, enforceable against Urovant in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally; and |
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(c) | the execution, delivery and performance of this Agreement do not and will not conflict with or result in a breach of or constitute a default under any indenture, instrument, agreement or documents to which Urovant or its Affiliates is a party or by which any of its assets or properties are bound. |
12.3 | WITHOUT PREJUDICE TO THIS ARTICLE 12, NEITHER PARTY MAKES ANY OTHER REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. |
12.4 | EXCEPT FOR EACH PARTY’S LIABILITY FOR BREACH OF THE OBLIGATIONS WITH RESPECT TO THE OTHER PARTY’S CONFIDENTIAL INFORMATION AS PROVIDED IN ARTICLE 11, EACH PARTY’S INDEMNIFICATION OBLIGATIONS AS PROVIDED IN ARTICLE 13, AND EACH PARTY’S LIABILITY ARISING FROM ITS GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY HERETO FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, INCIDENTAL OR PUNITIVE DAMAGES, INCLUDING, BUT NOT LIMITED TO, LOST PROFITS, LOST SALES OR LOSS OF GOODWILL, EVEN IF THAT PARTY HAS BEEN PLACED ON NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. |
Article 13 Indemnification and Insurance
13.1 | Indemnification by Merck. Merck shall defend, indemnify and hold Urovant, its Affiliates and Sublicensees, and their respective officers, directors, shareholders, employees, agents and representatives (“Urovant Indemnitees”) harmless against any and all losses, damages, liabilities, expenses and costs, including reasonable attorneys’ fees (“Losses”) which the Urovant Indemnitees may become subject to as a result of any and all claims, suits, actions or proceedings, by any Third Party (“Claims”) arising from, related to, or attributable to (a) the breach of any of Merck’s representations, warranties and covenants contained in Section 12.1 of this Agreement, or the breach of any other agreements or undertakings of Merck in this Agreement and other related agreements, (b) the negligence or willful misconduct on the part of Merck (or any of its Affiliates or Licensees), or any officer, director, employee, agent or representative of Merck (or its Affiliates or Licensees) to the extent that any Losses are not the result of the negligence or willful misconduct of Urovant Indemnitees. In the event that Urovant is subject to any Claims that are within the scope of Merck’s indemnification obligation under this Section 13.1: (x) Urovant shall furnish Merck with written notice of any such Claim [***] days of the date on which Urovant receives notice thereof; (yi) Merck shall be solely responsible for the investigation, defense, settlement and discharge of such Claim; and (z) Urovant shall furnish Merck with all assistance reasonably requested by Merck in connection with the investigation, defense, settlement and discharge of such Claim. Urovant’s failure to |
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perform any of its obligations under this Section 13.1 shall not be deemed to constitute a breach by Urovant of this Agreement, and shall not relieve Merck of its indemnification obligation hereunder, unless Merck does not receive timely notice of such Claim, or Merck’s ability to defend and/or settle such Claim is otherwise materially impaired by Urovant’s failure hereunder, in which case Merck shall not be required to indemnify Urovant Indemnitees hereunder. |
13.2 | Indemnification by Urovant. Urovant shall defend, indemnify and hold Merck, its Affiliates and Licensees and their respective officers, directors, shareholders, employees, agents and representatives (“Merck Indemnitees”) harmless against any and all Losses which the Merck Indemnitees may become subject to as a result of the Claims arising from, related to, or attributable to (a) the breach of any of Urovant’s representations, warranties and covenants contained in Section 12.2 of this Agreement, or the breach of any other agreements or undertakings of Urovant in this Agreement and other related agreements, (b) the Development and Commercialization or other disposition of the Licensed Compound or Licensed Product by Urovant, and (c) the negligence or willful misconduct on the part of Urovant (or any of its Affiliates or Sublicensees), or any officer, director, employee, agent or representative of Urovant (or any of its Affiliates or Sublicensees) to the extent that any Losses are not the result of the negligence or willful misconduct of Merck Indemnitees. In the event that Merck is subject to any Claims that are within the scope of Urovant’s indemnification obligation under this Section 13.2: (x) Merck shall provide Urovant with written notice of any such Claim within [***] days after Merck receives notice of such Claim; (y) Urovant shall be solely responsible for the investigation, defense, settlement and discharge of such Claim; and (z) Merck shall provide Urovant with such assistance as Urovant shall reasonably request in connection with the investigation, defense, settlement and discharge of such Claim. Merck’s failure to perform any of its obligations under this Section 13.2 shall not be deemed to constitute a breach by Merck of this Agreement, and shall not relieve Urovant of its indemnification obligation hereunder, unless Urovant does not receive timely notice of such Claim, or Urovant’s ability to defend and/or settle such Claim is otherwise materially impaired by Merck’s failure hereunder, in which case Urovant shall not be required to indemnify Merck Indemnitees hereunder. |
13.3 | Other Claims. In the event that any Losses arise as a result of any claim, suit, action or proceeding by any Third Party relating to this Agreement that is not attributable to either Merck’s indemnity contained in Section 13.1 or Urovant’s indemnity contained in Section 13.2 (“Other Claim”), then to the extent (and only to the extent) that such Other Claim is not covered in full by Urovant’s insurance or Merck’s insurance pursuant to Section 13.4, or if responsibility is not otherwise allocated pursuant to the terms of this Agreement, then Losses for such Other Claim shall be equally shared by the Parties. The Parties expressly agree that in the event that an Other Claim is covered in full by either Party’s insurance, then the insurance proceeds received as a result of such Other Claim shall be shared by the Parties in proportion to the Losses incurred by each Party. |
13.4 | Insurance. Each Party shall, at its sole cost and expense, obtain no later than the First Commercial Sale, and shall maintain in full force and effect during the Term and |
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thereafter in accordance with Section 13.5, commercial general liability insurance, which shall provide product liability coverage which complies with all Applicable Laws of the Territory of such First Commercial Sale, and provides for minimum loss coverage of at least equal to the insurance coverage maintained by each Party with respect to its proprietary pharmaceutical products. Each Party hereby specifically acknowledges and agrees that this Section 13.4 shall not be construed to create any limit on its liability hereunder and/or indemnification obligation under Section 13.1 or 13.2. |
13.5 | Survival. Each Party’s insurance obligation set forth in Section 13.4 shall survive the expiration or termination of this Agreement for a period of three (3) years after the date of such expiration or termination. |
Article 14 Term and Termination
14.4 |
33
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
under the bankruptcy provisions of the Applicable Laws, is declared insolvent, undergoes voluntary or involuntary dissolution, makes an assignment for the benefit of creditors, fails or is unable to pay its debts as they come due, or suffers the appointment of a receiver or trustee over all, or substantially all, of its assets or properties; provided, however, that in the case of any involuntary bankruptcy proceeding, such right to terminate shall only become effective if the proceeding is not dismissed within sixty (60) days after the filing thereof. |
14.6 | Effect of Expiration of Term. Upon the expiration of the Term (which for the avoidance of doubt, excludes early termination of this Agreement): |
(a) | Urovant shall have fully paid-up, royalty-free, perpetual, irrevocable and exclusive rights and licenses, with a right to grant sublicense, to the Licensed Compounds and/or the Licensed Products in the Field in the Territory; |
(b) | Urovant shall have fully paid-up, royalty-free, perpetual, irrevocable and non-exclusive rights and licenses, with a right to grant sublicense, to use the Merck Intellectual Property and the Merck Know-How for the Manufacture, Development and Commercialization of the Licensed Compounds and/or the Licensed Products in the Field in the Territory; and |
(c) | Urovant shall have fully paid-up, royalty-free, perpetual, irrevocable and non-exclusive rights and licenses, with a right to grant sublicense, to use the Merck Intellectual Property and the Merck Know-How for the Manufacture and the Development of Licensed Compounds and/or Licensed Products in the Field outside the Territory, solely for the purposes of obtaining Regulatory Approvals in the Territory and Commercializing Licensed Products in the Field in the Territory. |
Article 15 Consequences of Early Termination
34
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
(a) | Urovant shall immediately cease the Development and Commercialization in connection with the Licensed Product in the Field in the Territory; |
(b) | All rights and licenses granted to Urovant by Merck hereunder shall automatically terminate and revert to Merck at no cost to Merck; |
(c) | Urovant shall furnish Merck, or Merck’s designee, with all assistance reasonably requested by Merck, or its designee, in order to assure the transition of all then-ongoing Clinical Trials and all Regulatory Approvals in the Territory held by Urovant, if any, from Urovant to Merck, or its designee, in accordance with all Applicable Laws and applicable ethical standards; |
(d) | Urovant shall, at no cost to Merck, assign to Merck or its designee any Regulatory Approvals, drug dossiers and regulatory documentation with respect to the Licensed Product that Urovant and/or its Affiliates Controls at the time of such termination to the extent that such Regulatory Approvals, drug dossiers and regulatory documentation are necessary for Merck or its designee to continue Development and/or Commercialization of the Licensed Product in the Field in the Territory; |
(e) | Urovant shall pay to Merck the sum of (i) all amounts payable hereunder to Merck which have accrued but which remain outstanding as of the date of termination and (ii) the unpaid Milestone Payments (if the milestone events set forth in Section 6.2 have been achieved on or before the effective date of termination), minus any amounts payable hereunder by Merck to Urovant which have accrued but which remain outstanding as of the date of termination; |
(f) | Urovant shall have no further rights under the Regulatory Approvals in the Territory, except as required by Applicable Laws, until the effective date of assignment of such Regulatory Approval. Urovant shall execute and transfer to Merck or its designee all Regulatory Approvals in the Territory, and all notifications, consents and other documents and instruments as may be reasonably required to confirm the termination of all of Urovant’s rights hereunder; and |
(g) | Merck shall have fully paid-up, royalty-free, non-exclusive, perpetual and irrevocable rights and licenses, with a right to grant sublicense, to use the Urovant Intellectual Property and the Urovant Know-How for the Development and Commercialization of the Merck Licensed Product in the Field in the Territory and outside the Territory. |
15.2 | Termination by Urovant for Breach or Bankruptcy. In the event that this Agreement is terminated by Urovant in accordance with Section 14.4 (to the maximum extent legally permissible) or 14.5: |
35
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
(a) | Urovant shall have fully paid-up, royalty-free, perpetual, irrevocable and exclusive rights and licenses, with a right to grant sublicense, to use the Merck Intellectual Property in connection with Development and Commercialization of Licensed Compounds and/or Licensed Products in the Field in the Territory; |
(b) | Urovant shall have fully paid-up, royalty-free, perpetual, irrevocable and non-exclusive rights and licenses, with a right to grant sublicense, to use the Merck Intellectual Property for the Development of Licensed Compounds and/or Licensed Products in the Field outside the Territory, solely for the purposes of obtaining Regulatory Approvals in the Territory and Commercializing Licensed Products in the Field in the Territory; |
(c) | All rights and licenses granted to Merck by Urovant hereunder shall automatically terminate and revert to Urovant at no cost to Urovant; |
(d) | Merck shall immediately disclose or make available to Urovant all the Merck Intellectual Property and the Merck Know-How in Merck’s possession which have not been disclosed to Urovant and shall assign to Urovant, at no cost to Urovant, any Regulatory Approvals, drug dossiers and Regulatory Documentation with respect to Licensed Compounds and Licensed Products that Merck and/or its Affiliates Controls at the time of such termination and has not already assigned to Urovant pursuant to the terms of this Agreement. |
Article 16 Ethics / Conflict of Interest
Ethical Business Clause
In performing its obligations hereunder, the Parties acknowledge that the corporate policy of each Party and its Affiliates require that each Party’s business be conducted within the letter and spirit of the law. By signing this Agreement, the Parties agree to conduct the business contemplated herein in a manner which is consistent with the Applicable Laws, including the U.S. Foreign Corrupt Practices Act, good business ethics, and the Ethical Business Practices Policy of Merck as communicated to Urovant by Merck or one of its Affiliates from time to time. Specifically, the Parties warrant that in connection with this Agreement and the business relating thereto, they, their directors, employees, officers, and anyone acting on the behalf of any of the foregoing shall not offer, make or promise any payment, either directly or indirectly, of money or other assets (hereinafter collectively referred to as “Payment”), to any government (including a Governmental
36
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
Agency), political party or international organization, official, candidate or persons acting on behalf of any of the foregoing or directly associated with them, including their staff, business partners, close associates and family (hereinafter collectively referred to as “Officials”) where such Payment would constitute a violation of any Applicable Laws. In addition, regardless of legality, the Parties shall make no Payment, either directly or indirectly, to Officials if such Payment is for the purpose of influencing decisions or actions with respect to the subject matter of this Agreement or the business activities related thereto.
Each Party represents and warrants that, to the best of its knowledge, it has provided complete and accurate information and documentation to the other Party, its Affiliates, and its personnel in the course of any due diligence that was conducted, including disclosure of any officers, employees, owners, or persons directly or indirectly retained by such Party who are in a capacity that may reasonably provide an opportunity to influence decisions or actions with respect to the subject matter of this Agreement or the business activities related thereto. Each Party also acknowledges and agrees that, in the event that it engages an Affiliate, subcontractor or agent, it will conduct due diligence on such Affiliate, subcontractor or agent consistent with the requirements set forth in this Article 16 and will maintain adequate records of such due diligence and notify the other Party if any risk of violation of the requirements as set forth in this Article 16 is identified. Each Party shall make all further disclosures necessary to ensure the information provided remains complete and accurate for the duration of the engagement. Each Party further covenants that any future information and documentation submitted as part of further due diligence, or any certification, shall be complete and accurate to the best of its knowledge.
Each Party represents, warrants, and covenants that all books, records, invoices, and other documents relating to payments and expenses under this Agreement are and shall be complete and accurate and reflect in reasonable detail the character and amount of transactions and expenditures.
Each Party further represents, warrants and agrees that no “off the books” or other similar funds will be maintained or used in connection with this Agreement. Except as expressly provided for in this Agreement, without obtaining the prior written consent of the other Party, which shall not be unreasonably withheld, each Party shall not hire or retain subcontractors or agents who such Party knows or reasonably believes will be interacting with Officials on behalf of or at the request of such Party, who may have an opportunity to influence decisions or actions with respect to the subject matter of this Agreement or the business activities related thereto.
Each Party agrees to ensure that all of its employees, agents and subcontractors involved in performing the obligations under this Agreement are made specifically aware of the compliance requirements under this Article 16 by appropriate means, including without limitation, providing training regarding such requirements prior to performing any obligations under this Agreement. Each Party further agrees to certify its employees’, agent’s or subcontractors’ continuing compliance with the requirements under this Article
37
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
16 at any time requested by the other Party during the Term. Each Party agrees to implement and/or sustain a compliance program, to comply with the requirements of this Article 16 and to maintain adequate records of such compliance program.
Each Party shall have the right to audit the books and records of the other Party to ensure compliance with this Article 16 for the period of [***] following expiration or termination of this Agreement.
Each Party shall have the right to terminate the Agreement immediately upon any violation of this Article 16 or any breach of a representation or warranty contained under this Article 16.
17.3 |
38
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
in the event that an event of force majeure prevents either Party from making any payment to the other Party in a timely manner, as provided in Article 6, interest on such unpaid amount shall nonetheless accrue in accordance with the provisions of Section 6.9. For purposes of this Section 17.3, an event of force majeure shall mean and include, war, civil war, insurrection, rebellion, civil unrest, fire, flood, earthquake, adverse weather conditions, pandemic flu, strike, lockout, labor unrest, unavailability of supplies, materials or transportation, acts of the public enemy, acts of government authorities (including but not limited to the refusal of the competent Government Agencies to issue required Regulatory Approvals), and, in general, any other cause or condition beyond the reasonable control of the Party whose performance is affected thereby. In the event that the Party’s performance is affected by the occurrence of any event of force majeure, that Party shall furnish immediate written notice thereof to the other Party hereto. |
To Merck: | Merck Sharp & Dohme Corp. | |
0000 Xxxxxxxxx Xxxx Xxxx | ||
Xxxxxxxxxx, XX 00000 | ||
Attention: Office of Secretary | ||
Facsimile No.: [***] | ||
With copy to: | Merck Sharp & Dohme Corp. | |
0000 Xxxxxxxxx Xxxx Xxxx | ||
[***] | ||
Xxxxxxxxxx, XX 00000 | ||
Attention: Vice President, Transactions Business Development & Licensing, MRL | ||
[***] | ||
Facsimile No.: [***] | ||
To Urovant: | Urovant Sciences GmbH | |
x/x Xxxxxxx XX | ||
Xxxxxxxxxxxxxxx 0 | ||
XX-0000 Xxxxx | ||
Xxxxxxxxxxx | ||
With copy to: | Urovant Sciences, Inc. | |
000 Xxxx 00xx Xxxxxx | ||
0xx Xxxxx | ||
Xxx Xxxx, XX 00000 | ||
Attention: Legal Department |
39
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
All notices, reports and other communications given in accordance with this Section 17.4 shall be deemed received: (a) if sent by registered air mail, seven (7) calendar days after the date of mailing; (b) if sent by international air courier, two (2) calendar days after the date of dispatch; or (c) if sent by email, twenty-four (24) hours after the time of transmission.
17.5 | Governing Law. This Agreement shall be governed by and construed exclusively in accordance with the laws of State of New York and, with respect to the Patent Rights and related matters, the patent laws of the relevant patent granting jurisdiction (except that as between the Parties, inventorship shall be determined under US patent law), without reference to any rules of conflicts of law or renvoi. It is expressly agreed that the United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement. |
17.6 | Dispute Resolution |
(b) |
40
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
their resolution of the dispute that shall set forth in reasonable detail the facts of the dispute and the reasons for their decision. The decision of the arbitrators shall be final and non-appealable and binding on the Parties. As used in this Section 17.6(b), the phrase “Excluded Claim” shall mean a dispute, controversy or claim that concerns (a) the validity or infringement of a patent, trademark or copyright; or (b) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory. |
(c) | The arbitration proceeding shall be conducted under the Commercial Arbitration Rules of the American Arbitration Association with such proceedings to be held in New York, New York, United States. The arbitrators will apply the substantive law specified in Section 17.5. In all cases, the arbitration proceedings shall be conducted in the English language, and all documents that are submitted in the proceeding shall be in the English language. Judgment upon the award rendered by arbitration may be issued and enforced by any court having competent jurisdiction. The arbitrator’s fees and expenses shall be shared equally by the Parties. Each Party shall bear and pay its own expenses incurred in connection with any dispute resolution under this Section 17.6. The arbitration proceedings and the outcome thereof shall be confidential. Notwithstanding the foregoing, either Party shall have the right, without waiving any right or remedy available to such Party under this Agreement or otherwise, to seek and obtain from any court of competent jurisdiction any interim or provisional relief that is necessary or desirable to protect the rights or property of such Party, pending the selection of the arbitrator hereunder or pending the arbitrator’s decision of the dispute subject to arbitration. |
17.9 |
41
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
by the Applicable Laws, to such invalid or unenforceable provision. The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of the other provisions of this Agreement. |
17.11 | Headings. The subject headings of this Agreement are included for purposes of convenience only, and shall not affect the construction or interpretation of any provision of this Agreement. |
17.15 | [***] |
[Signature page follows]
42
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
EXECUTION VERSION
Merck Sharp & Dohme Corp. | Urovant Sciences GmbH | |||||||
By: | /s/ Xxxx X. XxXxxxxxx | By: | /s/ Xxxxxxxx Xxxxx Xxxxxxxx | |||||
Name: Xxxx X. XxXxxxxxx | Name: Xxxxxxxx Xxxxx Xxxxxxxx | |||||||
Title: SVP and Treasurer | Title: Managing Director |
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
Schedule 1.16
[***]
1
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
Schedule 1.46
Licensee Territory
Japan
[***] the following countries may be added to the Licensee Territory no later [***] following execution of this Agreement: Brunei, Cambodia, Hong Kong, Indonesia, Korea, Laos, Malaysia, Myanmar, Philippines, Singapore, Taiwan, Thailand, and Vietnam.
2
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
Schedule 1.47
[***]
3
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
Schedule 1.55
[***]
4
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
Schedule 1.56
[***]
5
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
Schedule 3.1
[***]
6
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
FIRST AMENDMENT to
LICENSE AGREEMENT by and between
MERCK SHARP & DOHME CORP.
and
UROVANT SCIENCES GMBH
THIS AMENDMENT is made and entered into this April 27, 2017, by and between Merck Sharp & Dohme Corp. (“Merck”) and Urovant Sciences GmbH (“Urovant”) to amend the terms of that LICENSE AGREEMENT entered into between Merck and Urovant dated February 3, 2017.
Section 11.2 of the LICENSE AGREEMENT (Disclosure of Confidential Information) is hereby amended to add the following subsection (d):
(d) to be disclosed by Urovant or its Affiliates to actual or potential investment bankers, investors or lenders, or their respective representatives; provided that such actual or potential investment bankers, investors or lenders, or their respective representatives, shall be bound by a confidentiality and non-disclosure agreement for a period of no less than two (2) years.
The final clause of Section l l.2(a) of the LICENSE AGREEMENT is hereby amended to read as follows:
provided, that the term of confidentiality for such Affiliates and/or Third Parties shall be no less than [***].
MERCK SHARP & DOHME CORP. | UROVANT SCIENCES GMBH | |||||||
By: | /s/ Xxxxx Xxxxxxxxxx | By: | /s/ Xxxxxxxx Xxxxx Xxxxxxxx | |||||
Name: Xxxxx Xxxxxxxxxx | Name: | Xxxxxxxx Xxxxx Xxxxxxxx | ||||||
Title: Head - Strategy, Transactions & Operations, Business Development & Licensing, Merck Research Laboratories | Title: | Managing Director |
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
SECOND AMENDMENT to LICENSE AGREEMENT by and between
MERCK XXXXXX & DOHME CORP. and UROVANT SCIENCES GMBH
THIS SECOND AMENDMENT (“Amendment”) is made and entered into this March 19th 2018 (the “Effective Date”), by and between Merck Sharp & Dohme Corp. (“Merck”) and Urovant Sciences GmbH (“Urovant”), to amend the terms of that LICENSE AGREEMENT between Merck and Urovant dated February 3, 2017.
Section 2.6 entitled “Sublicenses” is hereby amended and replaced with the following language:
Urovant may grant a sublicense of any of the rights and licenses granted to it by Merck under Sections 2.1 and 2.2 to its Affiliates or any Third Party without obtaining Merck’s prior written consent; provided, however, that if Urovant determines at any time to seek a Third Party to take over all Commercialization of all Licensed Products in the Territory, Urovant shall, prior to completing negotiations with any prospective Third Party, notify Merck in writing of its decision. Following receipt of such notice, Merck shall have thirty (30) days to provide Urovant with proposed terms pursuant to which Merck would acquire from Urovant the right to market the Licensed Product in the Territory. Urovant shall consider such proposal from Merck, if any, in good faith, provided that Urovant shall have no obligation to negotiate or enter into any agreement with Merck with respect to such Licensed Products, or to suspend or delay discussions with any prospective Third Party. For the avoidance of doubt, any Sublicensee may grant further sublicenses consistent with the terms set forth in this Agreement, including this Section 2.6. Each such agreement under which a sublicense is granted under the license as set forth in Sections 2.1 and 2.2 (“Sublicense Agreement”) shall be consistent with the terms and conditions of this Agreement. Urovant shall use commercially reasonable efforts to (a) procure the performance by any Sublicensee of the terms of each applicable Sublicense Agreement, and (b) ensure that any Sublicensee will comply with the applicable terms and conditions of this Agreement, including compliance with all Applicable Laws and ethical business practices. Urovant hereby guarantees the performance of its Sublicensees that are party to a Sublicense Agreement as permitted herein, and the grant of any such sublicense will not relieve Urovant of its obligations under this Agreement, except to the extent such obligations are satisfactorily performed by such Sublicensee.
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
[Signature page follows]
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
MERCK SHARP & DOHME CORP. | UROVANT SCIENCES GMBH | |||||||
By: | /s/ Xxxxx Xxxxxxxxxx | By: | /s/ Xxxxxxxx Xxxxx Xxxxxxxx | |||||
Name: | Xxxxx Xxxxxxxxxx | Name: | Xxxxxxxx Xxxxx Xxxxxxxx | |||||
Title: Head - Strategy, Transactions & Operations, Business Development & Licensing, Merck Research Laboratories | Title: | Managing Director |
[***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.