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

Intellectual Property | Ownership of IP

Summary of Approaches

Is the ownership of background IP impacted by this agreement What is the scope of background IP? How will sideground IP be treated?
- The parties retain respective ownership of any IP or Know-How that was: (i) existing and controlled by that Party on the Effective Date of the Agreement; or (ii) developed or obtained by or on behalf of the Party independently from the Agreement (sideground IP).
- All IP in relation to the Vaccine Components and the Licensed Know-How remains the exclusive property of Novavax.
Who will own new intellectual property arising from the project?
- Subject to certain carve outs that are redacted, SIIPL exclusively owns the Intellectual Property Rights in the Product.
- Ownership of SIIPL Improvements related to the Drug Substance will follow inventorship.

Annotations

This COVID-19 vaccine Supply and License Agreement between Serum Institute of India Private Limited (“SIIPL”) and Novavax, Inc. (“Novavax”) is effective from July 30, 2020 and amended on September 11, 2020. Amended terms are noted where applicable.

The agreement is heavily redacted, particularly terms related to intellectual property, indemnification, limitation of liability and dispute resolution. Based on the information disclosed in the agreement, Novavax: (a) supplies to SIIPL certain Vaccine Components exclusively owned by Novavax (i.e., NVX-CoV2373 as Drug Substance and Matrix-M™ as Adjuvant); (b) grants to SIIPL an exclusive royalty bearing license in the SIIPL Exclusive Territory to use the Vaccine Components to manufacture and commercialize a vaccine product developed from the coformulation of Vaccine Components (“Product”) for human prophylactic uses in SARS-CoV-2 disease (“Field”); (c) grants to SIIPL a nonexclusive royalty bearing license in the SIIPL Non–Exclusive Territory to use the Vaccine Components to manufacture and commercialize the Product; and (d) provides to SIIPL that Licensed Know–How Controlled by Novavax or its Affiliates in accordance with the terms and conditions of the Agreement. SIIPL agrees to pay Novavax a royalty equaling 50% of the revenue from the sale of Product and certain undisclosed prices for the Vaccine Components.

The definition of “territory” under the agreement differs during and after the Pandemic Period (i.e., the period during which the World Health Organization declares a Public Health Emergency of International Concern in relation to the SARS-CoV-2 virus). The SIIPL Exclusive Territory under the agreement is India. The SIIPL Non-Exclusive Territory during the Pandemic Period is any country except India and a redacted list of countries forming the Novavax Exclusive Territory. After the Pandemic Period, the SIIPL Non-Exclusive Territory is the countries designated as low and middle income countries according to the Word Bank classification as of the first day of the end of the Pandemic Period.

The agreement also makes reference to a separate funding agreement between CEPI and Novavax under which Novavax is required to make COVID-19 vaccines available to the COVAX Facility.

This agreement is also referenced in a separate advance purchase agreement for COVID-19 vaccines between Gavi and Novavax.

Provision Language

Definitionsstrong>em>p>
“Licensed Know-How strong>” means all Know–How that is Controlled by Novavax or its Affiliates as of the Effective Date in relation to the (a) Vaccine Components and (b) <a href=”#kt“>Manufacturea> of the Drug Substance, including any biological materials to be mutually agreed by the Parties , and which is necessary for the <a href=”#kt“>Developmenta>, Manufacture or <a href=”#kt“>Commercialization a> of Product.p>
“span>Novavax Improvements b>” span>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.p>
“span>SIIPL Improvements strong>” span>shall mean and include all Know-How , invented or developed during the Term (a) by SIIPL during the formulation, Manufacture, Development and further Commercialization of the Product or (b) solely by SIPPL during the Manufacture of the Drug Substance; provided in no case shall SIIPL Improvements include Novavax Improvements . ”span>p>
Recitalsb>span>p>
Novavax has developed and is the exclusive owner of NVX–CoV2373 (“span>Drug Substancei>b>”) and Matrix–MTM (“span>Adjuvanti>b>”) which are collectively referred to as the (“span>Vaccine Componentsi>b>”)span>p>
9. Intellectual Propertyb>span>p>
9.1 Ownership of Intellectual Property Rights [amended]b>p>
a. Subject to Sections 9.1(c) and 9.1(d), all proprietary rights, including any and all <a href=”#kt“>Intellectual Property Rights a>span> in the Product shall be exclusively owned and Controlled by and, shall remain exclusive property of SIIPL.span>p>
b. All proprietary rights, including any Intellectual Property Rights , in the [***] shall be span>exclusively owned and Controlled by [***].span>p>
c. All proprietary rights, including any Intellectual Property Rights , in the [***] shall be span>exclusively owned and Controlled by [***].span>p>
d. Nothing herein will affect the Parties’ respective ownership of any Intellectual Property Rights or <a href=”#kt“>Know-How a>span> (i) existing and Controlled by such Party as on the Effective Date of the Agreement or (ii) was developed or obtained by or on behalf of such Party independent of this Agreement, and without reliance upon the Confidential Information of the other Party (“span>Background IP i>b>”). For the sake of clarity all Intellectual Property Rights in relation to the Vaccine Components and the Licensed Know-How , shall be the exclusive proprietary concern of Novavax.span>p>
e. Inventorship of SIIPL Improvements pertaining to Drug Substance shall be determined in accordance with U.S. patent laws, and ownership shall follow inventorship. Novavax shall [***] disclose in writing to SIIPL of any Novavax Improvements to the Vaccine span>Components conceived, developed or reduced to practice during the Term. SIIPL shall span>[***] disclose in writing to Novavax of any SIIPL Improvements conceived, developed or reduced to practice during the Term.span>p>
 p>

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