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

Business model | Governance

Structural Questions

Do the parties govern the project through a joint steering committee (“JSC”)? If so, what are the parties expressly designated roles and responsibilities with respect to the JSC?
Are there other committees, important governance bodies, or designated individual positions? What are the parties’ roles and responsibilities with respect to them?
Are the parties required to meet in accordance with a defined schedule for decision-making and progress reporting activities?
What are the resolution mechanisms for disputes related to the agreement?
Are there any requirements for policies or procedures to manage potential conflicts of interest?

Summary of Approaches

Are the parties required to meet in accordance with a defined schedule for decision-making and progress reporting activities?
- The parties are required to meet regularly to discuss stock and production levels and expiry/shelf-life management of vaccines to avoid waste of doses due to expiration, including appropriate allocation and delivery.
- The parties must meet regularly to discuss past and expected allocations to COVAX participants.
What are the resolution mechanisms for disputes arising under this Agreement?
- The parties first must give notice of a dispute and refer it to the parties’ CEOs to resolve. If the CEOs fail to resolve the issue, then the parties must submit the matter for binding arbitration. The parties waive any rights to a judicial proceeding.
- A single expert, rather than arbitration, decides the following issues which may be cause for termination: (i) whether Novavax has made sufficient efforts to secure regulatory approval; and (ii) whether an adverse safety signal creates a material risk that the Novavax vaccine will not receive regulatory approval due to safety concerns.

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

Definitionsb>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>
“Novavax Dosesb>” means three hundred and fifty (350) million doses of CFN Vaccine as adjusted pursuant to Clause 2.2 (as applicable).p>
“span>NVSN Cumulative Volumeb>” means the cumulative volume of one billion and ninety–two million (1,092,000,000) doses of Novavax Doses and Covovax Vaccine to be supplied by Novavax and SII respectively.span>p>
“span>Stop Criterionb>” means the occurrence of an adverse safety signal in any population in which the Vaccine is being or has been tested that a Party, in good faith and in accordance with such Party’s medical safety evaluation, believes gives rise to a material risk that the safety profile of Vaccine is not suitable for <a href=”#kt“>Regulatory Approvala>.span>p>
4. strong>span>Novavax Supplyb>span>p>
4.7 b>In order to avoid expiration of CFN Vaccine before it can otherwise be delivered and effectively administered, Gavi and Novavax agree to discuss, on a [***] basis (or such other frequency as the Parties may agree), stock and production levels and expiry/shelf–life management of the CFN Vaccine. Provided always that Novavax is meeting its obligations under Clause 7, Gavi and Novavax further agree:span>p>
4.7.1 prior to <a href=”#kt“>Emergency Use Listing a> being granted by the WHO, to discuss in good faith appropriate allocation and delivery of any CFN Vaccines with an expiry date/shelf life of [***] or less; andspan>p>
4.7.2 subsequent to Emergency Use Listing being granted by the WHO:span>p>
(i) to discuss in good faith appropriate allocation and delivery of any CFN Vaccines with an expiry date/shelf life of [***] or less; andspan>p>
(ii) upon reasonable prior written notice to Gavi and in the absence of a contrary Gavi written request received within [***] of Gavi’s receipt of such notice, Novavax shall be permitted to deliver Expiring CFN Vaccine to a Novavax Buyer or other third party.span>p>
5. Allocation of COVAX Dosesb>span>p>
[…]p>
5.3strong> The Parties shall meet once every [***] (or such other frequency as agreed by the Parties) to review past allocations and expected allocations by Gavi of COVAX Doses to any COVAX Participant.span>p>
14. Disputes, Arbitration, Expert Determinationb>span>p>
14.1 b>Subject to Clause 14.2, all disputes arising out of or in connection with this Agreement, including disputes as to its conclusion, validity, existence, binding effect, amendment and termination, including a dispute as to the validity and existence of this Clause 14.1, which cannot be resolved by the CEOs of the Parties within [***] after notice of such dispute is first given by a Party to the other Party, shall be resolved by arbitration, in accordance with the [***] (the [***]) (the [***]). The number of arbitrators shall be [***], [***] appointed by or on behalf of each Party and the [***] arbitrator, who shall act as president of the tribunal, shall be appointed by the [***] arbitrators appointed by or on behalf of the Parties. If the [***] arbitrator is not chosen and nominated to the [***] for appointment within [***] of the date of confirmation of the later of the [***] party–appointed arbitrators to be confirmed by the [***], he/she shall be chosen by the [***]. No arbitrator shall be of the same nationality as any Party. The tribunal shall draw up, and submit to the Parties for signature, the terms of reference within [***] of receiving the file. The terms of reference shall not include a list of issues to be determined. The seat (or legal place) shall be in [***]. The language of the arbitration shall be English. The Parties agree to be bound by any award made by the tribunal. The Parties further agree to comply with any orders (including interim orders) in accordance with the terms of such orders. The Parties waive their right to any form of appeal, review or recourse to any state court or other legal authority, insofar as such waiver shall not be prohibited under any applicable law. For the avoidance of doubt, the Parties do not agree to opt out of the [***] (as defined in the [***]). The Parties undertake to fully comply with any order rendered by the emergency arbitrator in accordance with the terms of such order, to the extent that such order is not terminated or annulled by the emergency arbitrator or by the tribunal.span>p>
14.2 b>Where this Agreement refers to a <a href=”https://ghiaa.org/provision_document/gavi–alliance–novavax–covid–19–vaccine–advance–purchase–agreement–10/” target=”_blank” rel=”noopener“>determination by an Experta>span>, the Parties shall, within [***] of either Party serving details of a suggested expert on the other, agree the identity of the Expert and the proposed terms of his or her appointment.span>p>
14.2.1 If the Parties are unable to agree the identity and/or terms of his or her appointment within that period, either Party shall be entitled to request the [***] to appoint a suitable Expert and for the [***] to agree with the Expert the terms of his or her appointment.span>p>
14.2.2 The Parties shall be entitled to make submissions to the Expert. The Parties shall promptly provide to the Expert (imposing appropriate obligations of confidence with regard to third parties) all information reasonably requested by the Expert relating to the particular dispute.span>p>
14.2.3 The Parties shall require the Expert to prepare a written decision and to give notice (including a copy) of the decision to the Parties within a [***] of the matter being referred to the Expert (or such shorter time as the Parties may agree), and the Parties shall provide all reasonable co–operation to the Expert to achieve this objective.span>p>
14.2.4 The Expert will act as an Expert and not as an arbitrator and his or her decision will, except in the case of fraud, be final and binding on the Parties. Each Party will bear its own costs, [***]. All matters concerning the process and results of the determination by the Expert shall be kept confidential among the Parties and the Expert and shall be deemed <a href=”https://ghiaa.org/provision_document/gavi–alliance–novavax–covid–19–vaccine–advance–purchase–agreement–4/” target=”_blank” rel=”noopener“>Confidential Informationa>span> hereunder.span>p>

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

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