Master Alliance Provisions Guide (MAPGuide)

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

  • Liability | Representations & Warranties

10. Warranties, Representations and Covenants

10.1 Novavax Representations and Warranties. Novavax represents and warrants to SIIPL that:

a. the Vaccine Components supplied to SIIPL hereunder has been Manufactured according to all Applicable Laws and cGMPs; and

b. to its knowledge as of the Effective Date, Novavax Controls all rights, title, and interests in and to Intellectual Property Rights in the Vaccine Components and the Licensed Know-How[1] necessary for it to grant the licenses under Section 6.1 (License Grant);

10.2 SIIPL Representation and Warranty. [amended] SIIPL represents and warrants to Novavax that:

a. all Product shall be manufactured and commercialized by SIIPL according to all Applicable Laws and cGMPs.

b. SIIPL Controls all rights, title, and interests in and to its Background Intellectual Property it will use for the performance of this Agreement; including, without limitation, the Development, Manufacture, Commercialization or Exploitation, as applicable, of the Product and Drug Substance, and such use shall not violate or infringe, to the best of its knowledge, any Intellectual Property Rights of any third party.

10.3 Mutual. Each Party represents, warrants and covenants to the other Party:

a. Organization; Good Standing; Authority. It is duly organized, validly existing, and in good standing under the laws of its country of organization. It has the full right, power, and authority to enter into and perform this Agreement. This Agreement has been duly executed and delivered by an authorized signatory of each Party and constitutes a legal, valid, and binding obligation of such Party, enforceable in accordance with its terms.

b. No Conflicts. The execution, delivery, and performance of this Agreement by such Party does not conflict with such Party’s charter documents, bylaws, or other organizational documents, any material agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate Applicable Law or any order, writ, decree, judgment, injunction, determination, or award of any Governmental Authority having jurisdiction over it.

c. Compliance with Law. It will, and will ensure that its Affiliates, comply with all Applicable Laws and, to the extent applicable, professional certification or licensing requirements, with respect to the performance of its obligations under this Agreement.

d. No Litigation. There is no action or proceeding pending or, to the knowledge of such Party, threatened that could reasonably be expected to impair or delay the ability of such Party to perform its obligations under this Agreement.

e. No Debarment. Neither Party nor any of its Affiliates, or any of their employees, contractors or agents performing any activities under this Agreement, has been debarred or is subject to debarment pursuant to the relevant sections of the U.S. Food Drug & Cosmetic Act, as amended, or any foreign equivalent or that is the subject of a conviction described in such statutes and regulations. Authorization. Each Party’s representative signing below has the authority to bind its respective Party. Each Party hereto has the power and authority to execute and deliver the Agreement and to perform the obligations hereunder.

f. Anti-Corruption. The Parties agree that, at all times in connection with and throughout the term of this Agreement, they and their Affiliates will comply with and that they will take commercially reasonable measures to ensure that their subcontractors, agents or other third parties will comply with all applicable anti- corruption legislation including the United States Foreign Corrupt Practices Act 1977, as amended, and their foreigne quivalents under Applicable Law.

g. Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, TO THE OTHER PARTY WITH RESPECT TO ANY TECHNOLOGY OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, WITH RESPECT TO ANY AND ALL OF THE FOREGOING.

[1]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.