Provision Language
13. Project Continuity
13.1 Awardee Contingency Plan. [***] Awardee shall create and maintain a contingency plan, reasonably approved by CEPI, to address the possible impacts of the COVID–19 pandemic on its own organization as relates to the Project, as described in 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, for example, a Subawardee, under contract to Awardee that is capable of performing the activities in agreed Work Packages, Additional Work 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; and
(d) at least a preliminary identification of one or more geographically dispersed manufacturing sites, under contract with Awardee, to produce Project Vaccine for use in the Field (“Trusted Manufacturer”). Awardee shall make a final designation of one or more Trusted Manufacturers, in consultation with CEPI, and prior to the start of a Phase II clinical trial.
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13.5 Public Health License Triggers. Consistent with Clause 13.4, CEPI’s right to exercise the Public Health License shall be satisfied when: […]
(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;
14. Equitable Access
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14.3. Global Allocation. It is the Parties’ expectation that a global allocation and purchasing entity (the “Global Allocation Body”) shall be constituted within six (6) months after the Effective Date of this Agreement to purchase, allocate, and direct the distribution of COVID–19 vaccines including Project Vaccine. Awardee, will negotiate, in good faith a separate agreement or purchase order to supply Project Vaccine as may be required by the Global Allocation Body in such agreement or purchase order to the Global Allocation Body during the Pandemic Period and after the Pandemic Period for LMICs. For the purposes of this paragraph “Pandemic Period” means the period of time between the date that WHO declared COVID–19 to be a PHEIC [Public Health Emergency of International Concern] (that is, 30 January 2020) and the date that WHO declares the PHEIC to have ended including any period of a COVID–19 pandemic re–emergence as declared by the WHO.
14.4. Pandemic Period Production and Supply. During the Pandemic Period, Awardee shall:
(a) produce Project Vaccine as described in the Work Package(s), if not greater;
(b) provide the JMAG with a regularly updated [***] statement of its actual capacity and a forecast of its planned capacity for manufacturing of Project Vaccine;
(c) provide the JMAG with [***] advance written notice of each manufacturing run for the Project Vaccine;
(d) supply up to [***] of the quantity of the Project Vaccine produced for purchase by the Global Allocation Body pursuant to Clause 14.3 during the Pandemic Period. For clarity, Awardee may not allocate or obligate Project Vaccine doses to other third parties during the Pandemic Period that conflicts with its obligations under this Clause 14; and
(e) discuss in good faith with JMAG how to achieve its requirements for doses of Project Vaccine, including any potential increase in Awardee’s manufacturing capacity.
14.5. Post–Pandemic Period Production and Supply. After the Pandemic Period, Awardee shall continue to produce and supply Project Vaccine for purchase as required by the Global Allocation Body pursuant to Clause 14.3.
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14.10. Manufacturing in Multiple Countries. Awardee shall use [***] to establish operational manufacturing facilities in one or more geographically dispersed manufacturing sites as described in the Work Packages.
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14.12. Alternative to the Global Allocation Body. In the event that a Global Allocation Body is not constituted as expected by the Parties in Clause 14.3, then CEPI or its designated purchasing agent(s) shall have the rights attributed in this Clause 14 to the Global Allocation Body.
16. Representations and Warranties
16.2. Awardee Representation. 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.