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

Business model | Regulatory strategy

Structural Questions

Which party is responsible for obtaining and maintaining regulatory approvals?
In which jurisdiction(s) should the responsible party seek regulatory approvals?
Will the parties seek regulatory exclusivity in any jurisdictions?
How will the parties cooperate and share information in relation to the regulatory approvals process? Do the parties grant each other rights of reference to their regulatory materials?
What are the parties’ obligations in relation to pharmacovigilance activities?

Summary of Approaches

Which party is responsible for obtaining and maintaining regulatory approvals?
- Novavax will be the sponsor for all applications and approvals.
In which jurisdiction(s) should the responsible party seek regulatory approvals?
- Novavax must seek Emergency Use Listing and Prequalification from WHO and emergency authorization and regulatory approval from a stringent regulatory authority, such as the FDA or UK Medicines & Healthcare Products Regulatory Agency.
- Novavax must seek the regulatory approvals required for its vaccines to be used in COVAX countries that receive Novavax vaccines, taking into account cost, regulatory complexity, and the benefits of approval.
How will the parties cooperate and share information in relation to the regulatory approvals process? Do the parties grant each other rights of reference to their regulatory materials?
- Gavi will promote use of the Emergency Use Listing or WHO Prequalification by COVAX participant countries, in recognition of the significant resource requirement of obtaining regulatory approvals in multiple countries.
What are the parties’ obligations in relation to pharmacovigilance activities?
- The parties are required to share information about adverse events when they constitute serious “Stop Criterion.”

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

Definitions

“Stop Criterion” 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 Regulatory Approval;

7. Novavax Commitments

7.1 Regulatory Approval

7.1.1 Novavax shall deliver to Gavi the Regulatory Submission Plan on or before [***], which shall include a timeline for submission for approval of the Vaccine by the WHO for Emergency Use Listing, and for Regulatory Approval.

7.1.2 Novavax shall:

(i) use best endeavours to obtain Emergency Use Authorisation and Emergency Use Listing for the Vaccine by no later than [***] after the expected date set out in the Regulatory Submission Plan, and in any event by no later than [***] after submission for WHO assessment through the Emergency Use Listing or WHO Prequalification procedure; and shall ensure WHO submission is no later than the time of submission to the Stringent Regulatory Authority which is appointed to be the National Regulatory Authority of Record; and

(ii) use Commercially Reasonable Endeavours to obtain Regulatory Approval for the Vaccine, by no later than [***] after the expected date set out in the Regulatory Submission Plan.

7.1.3 Novavax shall use Commercially Reasonable Endeavours to obtain such regulatory approvals as are required to enable the Vaccine to be used in each COVAX Participant country where allocated COVAX Doses are intended to be sold pursuant to this Agreement, taking into account cost, complexity of obtaining approval in such COVAX Participant country and the benefit of such regulatory approval.

7.1.4 Where Novavax receives Emergency Use Authorisation for the Vaccine, but the Vaccine has not yet been granted Regulatory Approval, Novavax shall meet any requirements attached to the Emergency Use Authorisation.

7.1.5 Gavi recognizes the resource requirements for potentially complex regulatory processes and will [***], through outreach within the COVAX Facility and its partnerships in efforts to promote the use by COVAX Participant countries of either Emergency Use Listing and/or WHO Prequalification (including to the COVAX Partners). However, Novavax recognizes that Gavi cannot compel any regulatory authority to take any particular actions.

13. Term and Termination

[…]

13.2.3 If a Party, in good faith, considers the conditions of a Stop Criterion to be met, it shall notify the other Party thereof (the “Safety Notice”).

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

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