“CFN” means, for the purposes of this Agreement, the following manufacturing facilities funded in whole or part by CEPI under the CEPI Funding Agreement in which CFN Drug Substance is made: [***].
“CFN Drug Substance” means any drug substance manufactured using the CFN.
“CFN Vaccine” means any Vaccine that contains CFN Drug Substance.
4. Novavax Supply
4.8 Within [***] of the first day of each [***], Novavax shall provide Gavi with a [***] report detailing its [***] CFN Vaccine production and the total amount of CFN Vaccine it has delivered or otherwise made available to COVAX Buyers and Novavax Buyers in the previous [***].
9. Provision of Information
9.1 Novavax shall provide Gavi on an on–going basis as reasonably requested by Gavi with information in relation to [***].
9.2 Novavax shall notify Gavi promptly when [***].
9.3 Novavax shall promptly provide to Gavi all information reasonably required for the effective operation of the WHO no–fault compensation scheme. Novavax acknowledges that Gavi may share such information with the WHO for the purposes of the operation of the WHO no–fault compensation scheme.
9.4 Novavax shall provide to the COVAX Procurement Coordinator all of the information set out in Schedule 5 in accordance with the terms of that Schedule.
9.5 Novavax shall inform Gavi upon becoming aware of any credible suspicions of any Misappropriation, Fraudulent Practice, Corrupt Practice, Coercive Practice, Collusive Practice or Obstructive Practice (each, a “Prohibited Practice”). Further, if Gavi has reason to suspect that any payments made under this Agreement or any agreements contemplated as part of this Agreement (the “Funds”) have been used for purposes other than the development, manufacture and making available of the Vaccine, whether due to (i) non–compliance with the terms and conditions of the relevant agreement or (ii)Novavax’s engagement in a Prohibited Practice (each a “Misuse of Funds”), Gavi may, where permitted by law, inform Novavax. In the event of a Misuse of Funds or Novavax’s engagement in a Prohibited Practice, the Parties will consult in good faith with a view to agreeing upon a satisfactory resolution of the matter. If, following such consultation, no resolution is agreed by the Parties, Gavi may undertake an investigation (on its own behalf, or in conjunction with a third party), appoint an independent third party to investigate, or refer the matter to the appropriate authorities. If, following the completion of any investigation, Gavi determines that Novavax has engaged in the Misuse of Funds or a Prohibited Practice, Gavi may suspend all or part of its Funds. If Gavi notifies Novavax of its concern that Novavax has engaged in the Misuse of Funds or a Prohibited Practice, Novavax shall cooperate in good faith with Gavi and its representatives in determining whether such a violation has occurred and shall respond promptly and in reasonable detail to any such notice from Gavi and shall furnish documentary support for such response upon Gavi’s request
10.1 Upon advance written notice and during normal business hours, Novavax shall permit Gavi, and/or its designated representatives, which shall be an internationally recognised accounting firm or an international financial institution (an “Auditor”), to audit Novavax and its Affiliates:
10.1.1 from time to time (but in any case no more than [***]) to confirm Novavax’s compliance with this Agreement; and
10.2 Novavax shall ensure it provides all reasonable assistance to, and co-operates with, audits pursuant to Clause 10.1. Novavax shall, and shall procure its Affiliates shall, provide any Auditor with access to its premises, personnel, books, and records of any other relevant information. An Auditor shall not be entitled to access information over which Novavax can assert legal professional privilege. Any Confidential Information an Auditor obtains as a result of the audit shall be subject to Clause 16.1.
11. Representations, Warranties and Undertakings
11.2 Novavax Undertakings. During the Term of this Agreement, Novavax undertakes to:
11.2.1 notify Gavi [***] if it becomes aware that any actions are likely or have already been taken by the government of any country in which Novavax shall perform activities to procure COVAX Doses that may adversely affect Novavax’s commitments under this Agreement. For clarity, such government actions may relate, for example, to the exercise of eminent domain or sovereign rights over Vaccine doses contemplated to be procured as COVAX Doses under this Agreement;
11.2.3 inform Gavi of any [***];
11.2.5 inform Gavi of any [***]; and
11.2.6 keep Gavi informed of the supply of CFN Vaccine pursuant to its supply agreements with third parties pursuant to Clause 4.8.