Provision Language
Definitions
“Affected Territory” means any country, or any geographic area within a country, in which there is an Outbreak or for which there is anIncreased Outbreak Preparation Need. For clarity, the Affected Territory includes any country in Awardee’s Traveler’s Market and any Non-Traveler’s Market Countries, in each case in which there is an Outbreak or for which there is an Increased Outbreak Preparation Need.
“Awardee Background IP” means discoveries, inventions, know-how, patents and patent applications, trademarks and trademark applications, copyrights and copyrightable materials and other intellectual property rights that are owned or controlled by Awardee at the Effective Date or that Awardee develops, acquires or otherwise comes to own or control after the Effective Date outside the scope of the Project and without any CEPI funding.
“Enabling Rights” 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 Project Results and Product existing at the date that CEPI is first entitled to utilize the Public Health License pursuant to Clause 19 , 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.
“Project Results” – outcomes and results of the project, may comprise biological samples, data, intellectual property, materials, any Product and Investigational Product, publications, reference standards, technology and other results and shall include all Project IP, Project Data and Project Materials [cl. 12.1].
“Public Health License” means a non-exclusive, fully paid-up, royalty free, irrevocable, sublicensable license under the Project Results and Enabling Rights that is necessary or reasonably useful 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 the purpose of achieving Equitable Access during the Term and for twenty (20) years thereafter. For the purposes of this definition, the term ‘Product’ shall mean the Chikungunya Vaccine in any form or dosage of pharmaceutical composition or preparation for use in humans.
4. Project Funding and Work Package Streams
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4.6 Funding of Additional Work Packages
a. CEPI shall have the first right subject to section 4.6 c., in its sole discretion, to provide further funding and other support for the further development, manufacture and deployment of the Product in Non-Traveler’s Market countries. Such activities would be negotiated in good faith and set out in an additional Work Package(s) with associated project budget for such additional Work Packages amending Annex C. Nothing in this Clause 4.6 confers any obligation on CEPI to fund additional Work Packages.
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c. in the event that (a) awardee reasonably requires any third party funding for the development, manufacture or deployment of the Product in Non-Traveler’s Market countries; or (b) Awardee receives any offer or indication of interest from a third party, or identifies a call for proposal from a third party, to provide funding support for such development, manufacture or deployment, Awardee shall provide prompt written notice to CEPI, including a summary of the amount of funding required or offered and the terms (if any) offered by any potential third party funder (each a “Further Funding Notice”). CEPI shall provide written notice to Awardee that it does, or does not wish to provide such further funding within [***] of receipt by CEPI of a Further Funding Notice. After this period Awardee shall have the right to accept any third party funding support for the development, manufacture and deployment of the Product in Non Traveler’s Market countries provided CEPI (i) notifies Awardee that it does not wish to provide additional funding, or (ii) fails to provide Awardee with such notice within the [***] time period.
18. Preparation for Outbreaks
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18.8 Outbreak in Awardee’s Traveler’s Market. Notwithstanding anything to the contrary herein, in the event any country in the Awardee’s Traveler’s Market is included in the Affected Territory, Clauses 18 and 19 shall not apply to such country in the Awardee’s Traveler’s Market on the condition that Awardee shall, at the request of public health agencies in such country in the Awardee’s Traveler’s Market, supply the Product to all such public health agencies that request the Product in a quantity and at a price as agreed with the relevant public health agencies. The price agreed with the relevant public health agency shall not exceed the lowest supply price of the Product for similar volumes of Product agreed by Awardee with any customer in the Affected Territory in the [***] preceding the receipt of the Outbreak Notice by Awardee. For purposes of this Clause 18.8, “similar volume” shall mean a volume within the range of [***]. For clarity, if Awardee fails to comply with the foregoing supply obligation with respect to any country in the Awardee’s Traveler’s Market that is included in the Affected Territory, the terms of Clauses 18 and 19 shall apply to such country in the Awardee’s Traveler’s Market that is included in the Affected Territory. However, if the reason why Awardee cannot comply with the supply obligation is that (i) the quantity of Product requested by the relevant public health agency is impossible to fulfil due to Awardee’s capacities or (ii) the price proposed by the public health agency would be unsustainable to Awardee, Clauses 18 and 19 shall not apply in such case. In any case, “sustainable price” shall never be below Awardee’s manufacturing costs.
19. Public Health License
19.1 Grant of a Public Health License. Awardee hereby grants the public health license to CEPI (subject to Clause 18.8), on the condition that CEPI may only exercise the rights granted under the Public Health License in the following circumstances:
a. awardee’s activities supported by CEPI under the project have meaningfully advanced the Product; and
b. the awardee has not notified CEPI that it wishes to terminate the agreement pursuant to clause 22.2; and
c. one or more of the triggers set out in clause 19.2 has occurred.
19.2 Public Health License Triggers. Consistent with clause 19.1, CEPI’s right to exercise the public Health License will be triggered when:
a. awardee or trusted collaborator declines to participate in activities requested by CEPI under Clause 18.1 or 18.2;
b. CEPI determines, in good faith and having taken expert advice (for example from a sub-group or subcommittee of CEPI’s Scientific Advisory Committee that CEPI determines has appropriate expertise), that Awardee or Trusted Collaborator will not be able to perform the activities under Clause 18.1 or 18.2 if requested by CEPI;
c. awardee is in material breach of this agreement or the equitable access plan;
d. [***] have passed since an outbreak notice in accordance with clause 18.1 and the Parties including Trusted Collaborator have not signed an agreement or new Work Package for the activities contemplated under Clause 18.1 or Clause, as applicable, despite CEPI’s request; or
e. the agreement is terminated by CEPI pursuant to clause 22.2, 22.3a or 22.3d.
19.3 Agreement with Trusted Collaborator. In the event that the public health license becomes exercisable in accordance with Clause 19.1, CEPI may endeavour in good faith to reach agreement with a Trusted Collaborator to perform such activities as CEPI may deem necessary. If despite CEPI’s 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.
19.4 The awardee will:
a. identify enabling rights to CEPI as of the signature date of this agreement and provide updates to the JMAG regarding the Enabling Rights during the course of the Project;
b. promptly provide to CEPI an updated list of enabling rights and project results in the event that the Public Health License becomes exercisable;
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;
d. upon exercise of the public health license by CEPI, promptly and diligently make available to CEPI all guidance, information, Project IP, Enabling Rights, materials and assistance reasonably required to accomplish the Project activities identified by CEPI.