Master Alliance Provisions Guide (MAPGuide)

Novavax– CEPI Outbreak Response to Novel Coronavirus (COVID-19) Funding Agreement

  • Access to medicines | Public health licenses
  • IP ownership & licensing | Access to results

13.4. Public Health License. Subject to the terms of this Agreement, Awardee hereby grants a worldwide and royalty free Public Health License to CEPI, on the condition that CEPI may only exercise the rights granted under the Public Health License in the event that:

  • (a) CEPI is not in material breach of its obligations under this Agreement;
  • (b) the Project Vaccine has achieved licensure with at least one regulatory body (including but not limited to emergency licensure); and
  • (c) one or more of the triggers set out in Clause 13.5 has occurred.

CEPI shall be entitled to sublicense Project Results, Enabling IP and Background IP included in the Public Health License in accordance with this Clause 13. Each sublicense shall be in writing and CEPI shall require that each sublicensee complies with the terms of the Public Health License, and if receiving a sublicense to Third Party Background IP, also complies with the terms of the Third Party Background IP license agreement. If a license to Third Party Background IP does not permit further sublicensing by CEPI, Awardee agrees to directly grant CEPI’s designee a sublicense consistent with the Public Health License, provided such third party designee agrees to comply with the terms of the Third Party Background IP license agreement, including, without limitation, any payment of sublicense fees attributable to such sublicense grant. CEPI will remain responsible and liable for the performance of sublicenses under such sublicensed rights to the same extent as if such activities were conducted by CEPI.

13.5. Public Health License Triggers. Consistent with Clause 13.4, CEPI’s right to exercise the Public Health License shall be satisfied when:

  • (a) Awardee declines to participate in an Additional Work Package or Project Expansion as requested by CEPI, either directly or indirectly through a Subawardee; [“Work Package(s)” means a discrete set of activities in an iPDP as identified in Annex C. Additional Work Package(s) may be agreed to by the Parties after the Effective Date, which, upon execution by both Parties, shall be annexed to and become a part of this Agreement.]
  • (b) CEPI and Awardee agree, in good faith, that Awardee shall not be able to perform the activities under an agreed Work Package, either directly or indirectly through a Sub awardee; 
  • (c) Awardee is in material breach of this Agreement or the Equitable Access Plan and has not cured such breach within [***] days of notification of such breach by CEPI unless otherwise mutually agreed; or
  • (d) the Agreement is terminated by CEPI pursuant to Clause 19.2(a)-(b) (default or insolvency) or 19.3(c) – (e) (unavailability to perform Project activities, failure to satisfy payment criteria or fraud).

13.6. Agreement between CEPI and the Trusted Collaborator or Trusted Manufacturer. In the event that the Public Health License is exercised, CEPI may request assignment of the relevant Trusted Collaborator or Trusted Manufacturer contracts from Awardee or, at CEPI’s option, endeavour to reach agreement directly with the Trusted Collaborator and/or Trusted Manufacturer, as the case may be, to perform such activities as CEPI may deem necessary. At CEPI’s request, Awardee shall use [***] to facilitate the conclusion of a direct contractual relationship between the Trusted Collaborator or Trusted Manufacturer, as the case may be, and CEPI. If those negotiations do not result in an agreement in [***], then CEPI may grant rights under its Public Health License to a third party unilaterally designated by CEPI as a Trusted Collaborator or Trusted Manufacturer, without approval from Awardee.

13.7. Effects of Exercise of the Public Health License. Upon exercise of the Public Health License and written notice to Awardee, Awardee [***] shall:

  • (a) provide CEPI with an updated list of Enabling Rights and applicable Background IP, along with an invoice for any payments due under any license agreement for Third Party Background IP attributable to the grant of the Public Health License to CEPI or a sublicensee;
  • (b) provide CEPI with a good faith schedule of key technology transfer activities and estimated costs for the technology transfer in Clause 13.6;
  • (c) [***] transfer to the Trusted Collaborator and/or Trusted Manufacturer, as the case may be, and at CEPI’s reasonable cost, all Project Results, Project Materials described in Clause 13.2(b), all guidance, information, materials and assistance reasonably required to accomplish the Project activities identified by CEPI; and
  • (d) shall be deemed to have covenanted not to sue CEPI or designee for the exercise of the Public Health License

[“Enabling Rights” means rights to Intellectual Property and Project Results that could be asserted by Awardee to block CEPI from exercising its rights under Clause 13 of this Agreement. For purposes of this Agreement, Enabling Rights also includes the contractual rights under contracts executed for the Project that control the use of such items, for example, in material transfer agreements.]