Gavi Alliance – Novavax, COVID-19 Vaccine Advance Purchase Agreement

Protecting & sharing information | Information sharing

Summary of Approaches

What financial and project progress information must be shared between the parties? What is the required timeline for sharing information?
- Novavax has a number of information-sharing obligations, most of which are redacted. Unredacted information sharing obligations include:
  - Novavax must provide information to Gavi necessary to operate the WHO no-fault compensation scheme. Gavi may share the information with WHO for this purpose. (See this WHO press release for information about the scheme.)
  - Novavax must provide information to UNICEF or, in the future, other entities appointed to coordinate between vaccine manufacturers and COVAX participants. The information required to be disclosed is redacted.
  - Novavax must inform Gavi of any credible suspicions of improper or wrongful conduct, including the improper use of Gavi funds and the use of coercive of collusive practices.
  - Novavax must inform Gavi of any government activities that may adversely affect Novavax’s ability to satisfy its commitments, such as an exercise of sovereign rights over vaccines.
  - Novavax is required, periodically, to submit a report detailing its vaccine manufacturing, including the amount delivered to all COVAX and non-COVAX participants.
  - Novavax must provide regular updates about its efforts to secure supply contracts with COVAX buyers.
Do the parties have the right to verify the information reported?
- Gavi may inform Novavax of suspected misuse of funds when permitted by law. This disclosure triggers a dispute resolution procedure, which requires Novavax to negotiate a solution in good faith and may permit Gavi to conduct an independent investigation and suspend further payments.

Annotations

This Advance Purchase Agreement governs the supply of about 350 million doses of developer Novavax’s COVID-19 vaccine to participants in the Global COVID-19 Vaccine Facility (“COVAX Facility”), which was established to equitably distribute such vaccines worldwide. The parties to the Agreement are Novavax, which agrees to supply the doses, and the Gavi Alliance, a global health nonprofit organization, which agrees to make an advance payment and facilitate the sale of doses to COVAX buyers. The Agreement is effective as of May 5, 2021. The Parties intend that Novavax will deliver all doses to COVAX participants by the end of Q2 2022.

The Agreement facilitates Novavax’s fulfilment of its obligation in a funding agreement with the Coalition for Epidemic Preparedness Innovations (“CEPI”) to supply its vaccine to a then-unnamed “Global Allocation Body” for distribution to Lower- and Middle-income Countries (LMICs) and other nations. The purpose of Gavi’s advance payment is to “provide demand certainty” for Novavax and secure doses on behalf of COVAX participants with whom Novavax will enter into separate supply agreements. Gavi’s advance payment reduces the price they must pay on delivery. Gavi allocates Novavax doses between COVAX participants.

The Agreement contemplates that the Novavax licensee Serum Institute of India (“SII”) will be the primary source of Novavax vaccine to low- and middle-income countries, under the SII brand name “Covovax.” SII has a separate advance purchase agreement with Gavi for this purpose. The parties expect that Novavax and SII, collectively, will supply 1,092,000,000 vaccine doses under a tiered pricing framework. If SII is unable to meet its supply obligations, then Novavax must provide a ‘backstop supply’ to make up the shortfall.

Many key provisions and details have been redacted from this publicly available copy of the agreement.

Provision Language

Definitionsstrong>em>p>
“CFNb>” 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: [***].p>
“CFN Drug Substanceb>” means any drug substance manufactured using the CFN.p>
“CFN Vaccineb>” means any Vaccine that contains CFN Drug Substance.p>
4. Novavax Supplyb>span>p>
4.8 b>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 [***].span>p>
9. Provision of Informationb>span>p>
9.1 b>Novavax shall provide Gavi on an on–going basis as reasonably requested by Gavi with information in relation to [***].span>p>
9.2 b>Novavax shall notify Gavi promptly when [***].span>p>
9.3 b>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.span>p>
9.4 b>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.span>p>
9.5 b>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 “span>Prohibited Practiceb>em>”). Further, if Gavi has reason to suspect that any payments made under this Agreement or any agreements contemplated as part of this Agreement (the “span>Fundsb>em>”) 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 “span>Misuse of Fundsb>em>”), 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 requestspan>p>
11. Representations, Warranties and Undertakingsb>span>p>
11.2 Novavax Undertakings. b>During the Term of this Agreement, Novavax undertakes to:span>p>
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.span>p>

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