CEPI – University of Oxford – Barinthus Biotherapeutics, ChAdOx1 MERS Vaccine R&D Funding Agreement

Intellectual property | Ownership of IP
Intellectual property | Protection of IP

Structural Questions

Ownership of IP

Is the ownership of background intellectual property impacted by this agreement?
What is the scope of background intellectual property?
How will sideground intellectual property be treated?
Who will own new intellectual property arising from the project?

Protection of IP

Who has the decision-making authority and responsibility for patent prosecution, maintenance and enforcement?
Is there a mechanism for information sharing and cooperation between the parties in relation to patent prosecution, maintenance and enforcement activities?
Can the IP owner abandon the prosecution or maintenance of a patent?
How should IP protection expenses be allocated between the parties?

Summary of Approaches

Ownership of IP

Is the ownership of background intellectual property impacted by this agreement?
- Each Partner retains ownership of its own background IP.
What is the scope of background intellectual property? How will sideground intellectual property be treated?
- Background Intellectual Property includes IP that is either in existence as of the Effective Date, or later developed, acquired or in licensed independently of the Project, and is:
  - Necessary to complete the project.
  - For the specific purpose of the Public Health License, any intellectual property that Barinthus Bio or its affiliates have used or incorporated in developing or commercializing the Project Vaccine when the Public Health License is activated.
- Background IP specifically includes commercial freedom-to-operate licenses.
Who will own new intellectual property arising from the project?
- Each party will own any intellectual property that it creates during the performance of the project, as well as other Project Results.

Protection of IP

Who has the decision-making authority and responsibility for patent prosecution, maintenance and enforcement? How should IP protection expenses be allocated between the parties?
- Each Partner has the right, but not the obligation, to seek patent or other intellectual property protection for Project Intellectual Property at its own cost
Is there a mechanism for information sharing and cooperation between the parties in relation to patent prosecution, maintenance and enforcement activities?
- The Partners must provide written updates to CEPI regarding the status of any patent within the Project Intellectual Property upon reasonable request.

Annotations

This Funding Agreement (“Agreement“) between the Coalition for Epidemic Preparedness Innovations (“CEPI“), The Chancellor, Masters and Scholars of the University of Oxford (“Oxford“), and Barinthus Biotherapeutics (UK) Limited (“Barinthus Bio“) was signed in December 2023. The Agreement provides funding of up to $34.8 million to Barinthus Bio, in addition to funds previously committed to the University of Oxford, for the development of a MERS ChAdOx1 MERS vaccine candidate (“Project Vaccine”). The project will take the Project Vaccine from early development through Phase II clinical trials and potentially development of a ready reserve of investigational vaccines for deployment in a clinical trial setting in the event of disease outbreak.

Under the Agreement, CEPI will provide funding to the Partners (Oxford and Barinthus Bio) to undertake activities described in Work Packages. The funding is provided on a stage-gated basis, linked to the achievement of milestones. The Partners make commitments to equitable access principles including development and periodic update of an Equitable Access Plan (initially outlined in Annex E), affordable pricing in low- and middle-income countries, and technology transfer to selected manufacturers if needed to address outbreaks. The Agreement also includes the grant of a Public Health License to CEPI which may be exercised only under certain conditions for the purpose of achieving equitable access to the Project Vaccine.

Provision Language

Definitions

“Background Intellectual Property” (or “Background IP”) means any and all Intellectual Property: (a) necessary for completion of the Project, or (b) for the purposes of the Public Health Licence only, that has been used or incorporated, or is used or incorporated by Barinthus Bio or its Affiliates at the time that the Public Health Licence is triggered pursuant to Clause 14.6, in the development or commercialisation of the Project Vaccine, in each case ((a) and (b)) that is owned or controlled by either Partner during the Term of this Agreement that is: (i) in existence as of the Effective Date, or (ii) later developed, acquired or in licensed independently of the Project. For clarity, Background IP includes commercial freedom-to-operate licenses obtained by either Partner.

“Project Intellectual Property” (or “Project IP”) means the Intellectual Property conceived, invented or made by or on behalf of any Partner (whether solely or jointly) and/or any Subawardee in the performance of the Project.

“Project Results” means the Project Materials, Project Data and Technical Reports that are generated by or on behalf of a Partner and/or any Subawardee under the Project, including with respect to results of assays necessary for Project Clinical Trial Material manufacturing in support of such manufacturing by or on behalf of a Partner and/or any Subawardee under the Project, whether in whole or in components or serum samples collected. For clarity, Project Results does not include Project Clinical Trial Materials.

5. OWNERSHIP OF PROJECT RESULTS; INTELLECTUAL PROPERTY

5.1 Partners’ Background IP. Each Partner shall retain ownership of its Background IP. Other than pursuant to Clause 14.6, nothing in this Agreement shall be deemed to assign any ownership interest in or grant any license or other right to or under such Background IP to CEPI or any other person.

[…]

5.3 Ownership of Project Intellectual Property. Each Partner shall own all right, title and interest in and to the Project Intellectual Property created by or on behalf of such Partner. Each Partner shall have the right, but not the obligation, to seek patent or other intellectual property protection in respect of any Project Intellectual Property at its own cost. Upon reasonable written request, each Partner shall provide a written update to CEPI regarding the status of any patent within the Project Intellectual Property that is filed by or on behalf of a Partner.

5.4 Ownership of Project Results. Each Partner shall own all right, title and interest in and to the Project Results created by or on behalf of such Partner. For clarity CEPI shall have the right to use Project Results solely as expressly set out in this Agreement.

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