CEPI – VBI, COVID-19 Vaccine Development Funding Agreement

Business model | Benefit sharing

Summary of Approaches

How will the parties share any commercial benefits related to the project?
- During the pandemic period, CEPI agrees to forgo any share of potential Commercial Benefits as consideration for VBI’s acceptance and compliance with equitable access provisions.
- In the post-pandemic period, VBI is required to negotiate an agreement on sharing commercial benefit derived from sales of Project Vaccine that CEPI funded through phase 2 clinical trials. Exceptions are sales during a period of regional outbreak and those that occur in the 92 low- and middle-income countries eligible to participate in the COVAX Advance Market Commtment (AMC) program.

Annotations

This COVID-19 Outbreak Response Agreement is between the Coalition for Epidemic Preparedness Innovations (“CEPI”) and Variation Biotechnologies Inc. (“VBI”), a multinational biopharmaceutical company that develops infectious disease and oncology products. The Agreement is effective as of March 2021 and provides for funding of up to $33 million for development of VBI’s ‘VBI-2905’ enveloped virus like particle (“eVLP”) vaccine candidate through Phase 1 clinical trials. The scope of the funding also includes preclinical work for additional multivalent vaccine candidates intended to develop capacity to address emerging COVID-19 variants. VBI’s activities are further described in a redacted Integrated Product Development Plan (“IPDP”) which is divided into discrete Work Packages separated by Stage Gates.

VBI makes a number of equitable access commitments under the agreement including registration of the product in priority countries, making sales to COVAX, minimum supply volumes, and affordable and sustainable pricing. VBI also grants CEPI a Public Health License which is triggered under certain circumstances.

The agreement sets out a requirement for a Project Continuity Plan which includes the identification of a Trusted Collaborator who would be capable of performing the project activities if VBI is not able to do so, and the selection of a Trusted Manufacturer with geographically dispersed manufacturing sites located in LMICs who will be contracted to produce the project vaccine for use in the Field (the public health response to the COVID-19 pandemic).

In December 2022, the parties announced an expansion of their partnership to fund the broader development and optimization of VBI’s coronavirus vaccine program, including manufacturing scale-up.

Provision Language

Definitionsstrong>em>p>
“AMC Countriesb>” means those countries which are eligible to participate in the COVAX AMC from time to time (listed in Annex E as at the Effective Date).p>
16. Commercial Benefitsstrong>span>p>
16.1 Commercial Benefits.strong> CEPI is required by its own funders to obtain a share of any Awardee’s <a href=”#kt“>Commercial Benefitsa> as a contribution to support CEPI’s programme activities. For clarity, examples of Commercial Benefits include the sales of a Project Vaccine at market prices, commercial licensing of <a href=”#kt“>Project IP a>, receipt of government–granted incentives such as Priority Review Vouchers and revenue from the commercialisation of combination, derivative or follow–on products (including antibody products, assays and vaccines) or application of production technology resulting in whole or part from CEPI funding.p>
16.2 Waiver of Commercial Benefits.strong> In consideration for Awardee’s acceptance and compliance with the provisions of <a href=”https://ghiaa.org/provision_document/cepi–vbi–covid–19–vaccine–development –funding–agreement/” target=”_blank” rel=”noopener“>Clause 15a>span>, CEPI agrees to forgo any share of potential Commercial Benefits otherwise applicable under Sub–Clause 16.1 during the <a href=”#kt“>Pandemic Perioda>. Following the Pandemic Period and except during a period of regional <a href=”#kt“>Outbreaka> pursuant to Section 15.5.(c), the Awardee shall promptly notify CEPI of any Commercial Benefits in respect of any sales of a Project Vaccine for which CEPI provides funding through Phase 2 clinical studies (or any Project Vaccine if (i) this Agreement is terminated by CEPI pursuant to <a href=”https://ghiaa.org/provision_document/cepi–vbi–covid–19–vaccine–development –funding–agreement–17/” target=”_blank” rel=”noopener“>Clause 20.2 or Clause 20.3(c) – (e)a>span>; or (ii) Awardee does not accept further funding from CEPI offered on similar terms to those set out in this Agreement) in any country other than an AMC Country. Following receipt by CEPI of any such notice, Awardee and CEPI shall discuss the sharing of such Commercial Benefits in the Field, commensurate with CEPI’s funding contributions and stage of investment, through an appropriate mechanism agreed in good faith by the Parties within ninety (90) days.p>

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