Master Alliance Provisions Guide (MAPGuide)

Novavax – Serum Institute of India, COVID-19 Vaccine Supply and License Agreement

  • Intellectual Property | License Grants

Definitions

Licensed Patents” means the Patent Rights of Novavax in relation to the Vaccine Components, which are licensed to SIIPL under this Agreement, and which are annexed herein as Appendix C [appendix redacted].

Licensed Know-How” means all Know-How that is Controlled by Novavax or its Affiliates as of the Effective Date in relation to the Vaccine Components and which is necessary for the Development, Manufacture or Commercialization of Product.

Novavax Exclusive Territory” shall mean a) during the Pandemic Period (as determined by the WHO) the countries of [***] and b) immediately following the Pandemic Period, any other country designated as a high income country (including sub-designations of high income countries (e.g., a “low high income country”) according to the then most recent published Word Bank classification of world countries as of the first day of the end of the Pandemic Period or included within the Novavax Territory in accordance with Section 6.1.b. (Non-Exclusive License).

Novavax Improvements“shall mean and include all Know-How related to the Vaccine Components invented or developed solely by either Party or jointly by both Parties during the Term in the performance of this Agreement.

Novavax Proprietary Rights” means all proprietary rights, including any and all Intellectual Property Rights, in the Licensed Patents and Novavax Improvements.

Pandemic Period” shall mean worldwide situation/period which the World Health Organization declares as Public Health Emergency of International Concern in relation to the SARS-CoV-2 virus.

SIIPL Exclusive Territory” shall mean India.

SIIPL Non-Exclusive Territory” shall mean a) during the Pandemic Period all the other countries EXCEPT SIIPL Exclusive Territory and Novavax Exclusive Territory and b) immediately following the Pandemic Period only those countries designated as low or middle income countries (including any sub-designations of low or middle income countries (e.g., a “high middle income country”) according to the then most recent published Word Bank classification of countries as of the first day of the end of the Pandemic Period (“LMIC”), subject to and may be modified in accordance with Section 6.1.b. (Non-Exclusive License).

SIIPL Territory” shall mean SIIPL Exclusive Territory and SIIPL Non-Exclusive Territory together.

2. Supply and Other Responsibilities

[…]

2.6 Restrictions on Use. SIIPL may use the Vaccine Components supplied by Novavax and the Licensed Know How under this Agreement solely to (i) Manufacture the Product the Field for the SIIPL Territory, (ii) conduct analytical and process development activities, and (iii) Commercialize the Product in the SIIPL Territory. SIIPL will not, and will cause its Affiliates and other Permitted Recipients not to, (a) attempt to reverse engineer the Vaccine Components or otherwise analyze, circumvent, or design around the Vaccine Components, or (b) sell the Vaccine Components to any third party. Notwithstanding the foregoing. Upon [***] notice to Novavax, SIIPL may transfer Vaccine Components to Affiliates. Further, SIIPL may transfer the Vaccine Components to third party manufacturers engaged to Manufacture of the Product (Permitted Recipients) upon [***], provided that Permitted Recipients are bound by written restrictions on use and confidentiality no less stringent than those specified in this Agreement, and SIIPL remains liable to Novavax for such Permitted Recipients use of Vaccine Components. Nothing set forth in this Agreement will limit Novavaxability to Manufacture or supply Vaccine Components to any third party or to use the Vaccine Components for any other purposes.

6. License Grants

6.1 License Grants to SIIPL. [amended]

a. Exclusive License. Subject to the terms and conditions of this Agreement, Novavax hereby grants to SIIPL an exclusive but royalty bearing license under the Novavax Proprietary Rights to the extent necessary to use Vaccine Components and Licensed Know-How to Develop, formulate, Manufacture, make, have made, import, export, use, have used, offer for sale, sell, and have sold or otherwise and Commercialize the Product within the SIIPL Exclusive Territory in the Field during the Term (the “SIIPL Exclusive License”). For the purpose of clarity, the SIIPL Exclusive License does not and will not be deemed to allow SIIPL to make or have made the Vaccine Components in whole or part under this Agreement. This SIIPL Exclusive License shall continue during and after the Pandemic Period until expiration or termination of this Agreement.

b. Non–Exclusive License. Subject to the terms and conditions of this Agreement, Novavax hereby grants to SIIPL a non–exclusive but royalty bearing license under the Novavax Proprietary Rights to the extent necessary to use Vaccine Components and Licensed Know-How to Develop, formulate, Manufacture, make, have made, import, export, use, have used, offer for sale, sell, and have sold or otherwise and Commercialize the Product within the SIIPL Non–Exclusive Territory in the Field during the Pandemic Period. For the purpose of clarity, this non–exclusive license does not and will not be deemed to allow SIIPL to make or have made the Vaccine Components in whole or part under this Agreement. After the Pandemic Period, Novavax may, during the Term, notify in writing to SIIPL of any bona fide opportunity to license to a third party one or more countries in the SIIPL Non–Exclusive Territory. Upon any such written notice, SIIPL shall have [***] from receipt of the written notice to match or improve such bona fide terms with Novavax or, failing that, Novavax has the sole discretion to remove such country or countries from the SIIPL Non–Exclusive Territory with due written notice to SIIPL.

c. Manufacturing License. Subject to the terms and conditions of this Agreement, as amended, Novavax hereby grants to SIIPL a non–exclusive, sublicensable (subject to Novavax’ prior written consent) license under the Licensed Know–How and Licensed Patents to Manufacture the Drug Substance solely for use in the Manufacture of the Product in the Territory during the Term in the performance of this Agreement.

d. Sub–License. SIIPL may sub-license to a third party in the SIIPL Exclusive Territory, the Vaccine Components and Licensed Know-How with [***].

6.2 Covenant Not to Sue. SIIPL, on behalf of itself and its Affiliates, hereby covenants not to assert or cause to be asserted, and will cause its Affiliates not to assert or cause to be asserted, against any Covenant Beneficiary [***]. Each Covenant Beneficiary that is not party to this Agreement is a third party beneficiary solely of this Section 6.2 (Covenant Not to Sue). If SIIPL or any of its Affiliates sells, assigns, exclusively licenses, transfers, or otherwise grants any right under any SIIPL Improvement to a third party, then SIIPL or such Affiliate, as applicable, will require such purchaser, assignee, licensee, or transferee to agree in writing to be bound by the same covenant to the same extent as made by SIIPL and its Affiliates in this Section 6.2 (Covenant Not to Sue).

6.3 No Implied Licenses. Neither Party is granted any rights to any Patent Rights, Know-How, or other intellectual property rights owned or Controlled by the other Party, other than as explicitly identified herein. Nothing herein will affect the Parties’ respective ownership of any Patent Rights, Know-How, or other intellectual property rights owned by such Party.