Master Alliance Provisions Guide (MAPGuide)

CEPI – Valneva, Chikungunya Vaccine Funding Agreement

  • Equitable Access | Ensuring continuity
  • Intellectual Property | License Grants

<p><em><strong>Definitionsstrong>em>p>
<p>“<strong>Enabling Rightsstrong>” means any and all rights owned or controlled by the Awardee at the Effective Date, together with those which arise on or after the Effective Date, which in each case, relate to the development, manufacture, supply or marketing of the Product, including improvements to the <a href=”#kt“>Project Resultsa> and Product existing at the date that CEPI is first entitled to utilize the Public Health License pursuant to Clause 17, whether or not arising under the Project. Enabling Rights include applicable Awardee Background IP but do not include any rights that Awardee is contractually precluded from granting to CEPI.p>
<p>“<strong>Public Health Licensestrong>” means a nonexclusive, fully paidup, sublicensable license under the Project Results and Enabling Rights to develop, manufacture, market and/or supply the Product worldwide, provided that all end users of the Product are located in the Affected Territory; in each case for use in preparation for or response to an <span style=”textdecoration: underline;”><a href=”https://ghiaa.org/provision_document/cepivalnevachikungunyavaccinefundingagreement3/” target=”_blankrel=”noopener“>Outbreak or Increased Outbreak Preparation Needa>span>. For the purposes of this definition, the termProductshall mean the Chikungunya Investigational Vaccine in any form or dosage of pharmaceutical composition or preparation for use in humans.p>
<p><span style=”textdecoration: underline;”><strong>17. Public Health Licensestrong>span>p>
<p><strong>17.1 Grant of a Public Health License.strong> Awardee hereby grants the Public Health License to CEPI (subject to <span style=”textdecoration: underline;”><a href=”https://ghiaa.org/provision_document/cepivalnevachikungunyavaccinefundingagreement3/” target=”_blankrel=”noopener“>Clause 16.7a>span>), on the condition that CEPI may only exercise the rights granted under the Public Health License in the following circumstances:p>
<p style=”paddingleft: 40px;”>a. Awardees activities supported by CEPI under the Project have meaningfully advanced the Product; andp>
<p style=”paddingleft: 40px;”>b. the Awardee has not notified CEPI that it wishes to terminate the Agreement pursuant to <span style=”textdecoration: underline;”><a href=”https://ghiaa.org/provision_document/cepivalnevachikungunyavaccinefundingagreement15/” target=”_blankrel=”noopener“>Clause 20.2a>span>; andp>
<p style=”paddingleft: 40px;”>c. one or more of the triggers set out in Clause 17.2 has occurred.p>
<p><strong>17.2 Public Health License Triggers.strong> Consistent with Clause 17.1, CEPIs right to exercise the Public Health License will be triggered when:p>
<p style=”paddingleft: 40px;”>a. Awardee declines to participate in activities requested by CEPI under <span style=”textdecoration: underline;”><a href=”https://ghiaa.org/provision_document/cepivalnevachikungunyavaccinefundingagreement3/” target=”_blankrel=”noopener“>Clause 16.1 or 16.2a>span>,p>
<p style=”paddingleft: 40px;”>b. CEPI determines, in good faith and having taken expert advice (for example from a subgroup or subcommittee of CEPIs Scientific Advisory Committee that CEPI determines has appropriate expertise), that Awardee will not be able to perform the activities under Clause 16.1 or 16.2 if requested by CEPI,p>
<p style=”paddingleft: 40px;”>c. [***] have passed since an Outbreak Notice in accordance with Clause 16.1 and the Parties have not signed an agreement or new Work Package for the activities contemplated under Clause 16.1 or Clause, as applicable, despite CEPIs request; orp>
<p style=”paddingleft: 40px;”>d. the Agreement is terminated by CEPI pursuant to <span style=”textdecoration: underline;”><a href=”https://ghiaa.org/provision_document/cepivalnevachikungunyavaccinefundingagreement15/” target=”_blankrel=”noopener“>Clause 20.2, 20.3a) or 20.3c)a>span>.p>
<p><strong>17.3 Agreement with Trusted Collaborator.strong> In the event that the Public Health License becomes exercisable in accordance with Clause 17.1, CEPI may endeavor in good faith to reach agreement with a <a href=”#kt“>Trusted Collaboratora> to perform such activities as CEPI may deem necessary. If despite CEPIs good faith efforts those negotiations do not result, or CEPI reasonably deems that such negotiations are unlikely to result, in an agreement on a timely basis, then CEPI may grant rights under its Public Health License to a third party unilaterally designated as a Trusted Collaborator by CEPI.p>
<p><strong>17.4 The Awardee will:strong>p>
<p style=”paddingleft: 40px;”>a. identify Enabling Rights to CEPI as of the signature date of this Agreement and provide updates to the <a href=”#kt“>JMAGa> regarding the Enabling Rights during the course of the Project;p>
<p style=”paddingleft: 40px;”>b. provide an updated list of Enabling Rights to CEPI in the event that the Public Health License becomes exercisable.p>
<p style=”paddingleft: 40px;”>c. make no encumbrances regarding ownership or access to Project Results or Enabling Rights that would conflict or interfere with the Public Health License without the express written permission of CEPI, such permission not to be unreasonably withheld, conditioned or delayed.p>