Provision Language
Definitions
“Enabling Rights” means rights to Background Intellectual Property, Project Intellectual Property and Project Results that could be asserted by Awardee or a Subawardee to block CEPI from exercising the Public Health Licence to make, have made, use, have used, import, sell or otherwise exploit the Project Vaccine. For purposes of this Agreement, Enabling Rights also includes the contractual rights that control the use of such items as, for example, rights to use biological materials covered in material transfer agreements entered into between Awardee and third parties.
“Project Materials” – biological samples, Project Vaccines, and other tangible materials produced under the Project.
“Project Results” means all of the tangible materials and other results that are made or developed by or on behalf of Awardee and/or any Subawardee under the Project, including the Project Vaccine and assays developed by or on behalf of the Awardee or any Subawardee that are necessary for Project Vaccine production, whether in whole or in components, serum samples collected, protocols used in clinical or non–clinical evaluation of the Project Vaccine, Project Data, and Project Materials.
4. Further Funding
4.1 First Right to Fund. Where practicable CEPI likes to continue to participate in its programmes throughout their life cycle. In the event that (a) Awardee reasonably requires any funding for the development, manufacture and/or deployment of a Project Vaccine in addition to the funding to be provided by CEPI pursuant to the Budget; or (b) Awardee receives any offer or indication of interest from a third party to provide funding support for the development, manufacture and/or deployment of a Project Vaccine; 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 have the first right (but not the obligation), at CEPI’s sole discretion, to provide such further funding support to the Awardee for the development, manufacture and deployment of the Project Vaccine and shall provide written notice to the Awardee of any such election within thirty (30) days of receipt by CEPI of a Further Funding Notice. The Awardee shall not accept any third party funding support in respect of the development, manufacture and/or deployment of a Project Vaccine unless and until the earlier of (i) CEPI has provided written notice that it does not wish to provide such further funding; or (ii) Awardee has not received an election from CEPI to provide such further funding within thirty (30) days of receipt by CEPI of a Further Funding Notice.
4.2 Participation By Other Funders. Each Party acknowledges that additional third party funding support for the Project may become available to either Party. For example, other funders may offer to fund certain activities under a Work Package or the scale–up and scale–out of Project Vaccine production. Subject to Clause 4.1 and Awardee’s representations in Clause 17.2, the Parties shall, in good faith, use reasonable endeavours to facilitate such participation and make appropriate revisions to relevant Work Packages and the Budget, as well as managing any potentially conflicting commitments.
3. Project Continuity
13.1 Awardee Contingency Plan. Awardee shall prepare and maintain a contingency plan to minimise any potential disruption to the Project, and provide a copy of the plan to CEPI in confidence as it relates to the Project as required under the iPDP.
13.2 Project Continuity Plan. Because of the exigent nature of the Outbreak, the iPDP shall include a Project Continuity Plan that, at a minimum, shall address the following items:
(a) responsibilities and level of access on the part of other collaborators, Subawardees and consortium members, if any, to Project Results and Enabling Rights;
(b) management of key Project Materials through participants in the Project and other entities such as the BioEscrow® deposit service of the American Type Culture Collection;
(c) identification of a proposed third party, within a timeframe to be established in the iPDP, such as a Subawardee, under contract to Awardee, which is capable of performing the activities in agreed Work Packages, any additionalWork Packages or a Project expansion (“Trusted Collaborator”), in the event that Awardee is unable to continue its activities under this Agreement or declines CEPI’s request to undertake additional Work Packages or a Project expansion. Awardee’s Subawardee agreement(s) with Trusted Collaborator shall expressly permit Awardee to assign the agreement to CEPI if so requested by CEPI pursuant to Clause 13.6; and
(d) requirement for the Awardee to use its reasonable endeavours to sign Subawardee agreement(s) with one or more operational manufacturing facilities at one or more geographically dispersed manufacturing sites located inLMICs, within a timeframe to be established in the iPDP, or within such other time period as may be set out in the iPDP from time to time, whichAwardee will contract with as described in the iPDP to produce Project Vaccine for use in the Field (“Trusted Manufacturer”). Awardee’s Subawardee agreement(s) with Trusted Manufacturer(s) shall (i) comply with the relevant requirements of this Agreement; (ii) enable Awardee to use theTrusted Manufacturers to produce the Project Vaccine for supply in accordance with Clause 15.5 (Volume Commitment); (iii) shall include a right for CEPI to reserve manufacturing capacity with the Trusted Manufacturer; and (iv) shall expressly permit Awardee to assign the agreement to CEPI if so requested by CEPI pursuant to Clause 13.6. The terms of such Subawardee agreement shall be subject to CEPI’s prior written consent. Awardee shall notify CEPI of the identity of the Trusted Manufacturer(s) and provide a copy of the relevant final Subawardee agreement(s) to CEPI without undue delay after the entry into the Subawardee agreement(s).
13.3 Alternative Designations by CEPI. If Awardee does not designate a Trusted Collaborator and/or Trusted Manufacturer, or a designated Trusted Collaborator and/or Trusted Manufacturer notifies Awardee that they are no longer available, then CEPI may propose a Trusted Collaborator or Trusted Manufacturer to Awardee. Neither Party may unreasonably decline to accept the designation of a proposed Trusted Collaborator under Clause 13.2 or this Clause 13.3. Once designated and under contract to pursue Project activities, a Trusted Collaborator and Trusted Manufacturer shall be a Subawardee for the purposes of this Agreement.
13.4 Public Health Licence. Subject to the terms of this Agreement, Awardee hereby grants (and shall ensure that each Subawardee grants) a worldwide, non–exclusive, irrevocable, fully paid up, royalty free Public Health Licence to CEPI, on the condition that CEPI may only exercise the rights granted under the Public Health Licence in the event that:
(a) CEPI is not in material breach of its obligations under this Agreement; and
(b) one or more of the triggers set out in Clause 13.5 has occurred.
CEPI shall be entitled to sublicense Project Results and Enabling Rights included in the Public Health Licence in accordance with this Clause 13. Each sublicence shall be in writing and CEPI shall require that each sublicensee complies with the terms of the Public Health Licence.
13.5 Public Health Licence Triggers. Consistent with Clause 13.4, CEPI shall have the right to exercise the Public Health Licence in the event that any one or more of the following events occurs:
(a) Awardee declines to participate in an additional Work Package or Project expansion that CEPI has offered to fund, either directly or indirectly through a Subawardee;
(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 Subawardee;
(c) Awardee is in material breach of this Agreement or the Equitable Access Plan and has not cured such breach within thirty (30) Business Days of notification of such breach by CEPI, unless otherwise mutually agreed in writing; or
(d) the Agreement is terminated by CEPI pursuant to Clause 20.2(a)-(b) (default or insolvency) or 20.3(c) – (e) (unavailability to perform Project activities, failure to satisfy payment criteria or fraud).
For clarity, CEPI shall only have the right to exercise the Public Health Licence in the events set out in Clauses 13.5(a) and (b) during the Term.
In the event that CEPI exercises the Public Health Licence, CEPI shall provide prompt written notice of such exercise to VBI and shall use its reasonable endeavours to exploit the rights granted to it under such Public Health Licence. On expiry of the later of (i) the Term; (ii) the date that is five years from the end of the Pandemic Period; or (ii) ten years from the Effective Date; and provided that CEPI has not exercised its rights under the Public Health License in accordance with this Clause 13.5, the Public Health License granted pursuant to Clause 13.4 shall lapse and be of no further force and effect.
13.6 Agreement between CEPI and the Trusted Collaborator or Trusted Manufacturer. In the event that the Public Health Licence is exercised, CEPI may request assignment of the relevant Trusted Collaborator or Trusted Manufacturer contracts from Awardee to CEPI or, at CEPI’s discretion, CEPI may 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 all reasonable endeavours 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 within twenty (20) Business Days from the initiation of negotiations, then CEPI may grant rights under its Public Health Licence 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 Licence. Upon exercise of the Public Health Licence by CEPI and provision of written notice to Awardee, Awardee shall promptly:
(a) provide CEPI with an up–to–date list of Enabling Rights and applicable Background IP, along with an invoice for any payments due under any licence agreement for Third Party Background IP attributable to the grant of the Public Health Licence to CEPI or a sublicensee;
(b) provide CEPI with a good faith schedule of key technology transfer activities and estimated direct costs for the technology transfer in Clause 13.6;
(c) promptly and diligently transfer to the Trusted Collaborator and/or Trusted Manufacturer , as the case may be , 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. Such transfer shall be (i) in the event the Public Health Licence is exercised by CEPI pursuant to Clause 13.5(a) or (b), at CEPI’s reasonable cost; or (ii) in the event the Public Health Licence is exercised by CEPI pursuant to Clause 13.5(c) or (d), at Awardee’s cost; and
(d) and Awardee hereby does undertake not to sue CEPI or its designee for the exercise of the Public Health Licence.
17. Representations and Warranties
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17.2 Awardee Representations. During the Term of this Agreement, Awardee shall: […]
(e) notify CEPI promptly if it becomes aware that any actions are likely or have already been taken by the government of any country in which Awardee shall conduct Project activities that may adversely affect Awardee’s commitments in this Agreement, including Equitable Access. For clarity, such government actions may relate, for example, to the exercise of eminent domain or sovereign rights over Project Vaccine doses.
17.3 Additional Awardee Representation. In the event that the Public Health Licence becomes exercisable and irrespective of whether the Agreement has expired or been terminated, Awardee shall make no encumbrances over, dispose of, or otherwise deal with the Project Results, Project Intellectual Property and/or Enabling Rights, in any way that may be inconsistent with the Public Health Licence, without the express written permission of CEPI.