“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.
“Project Materials” means biological samples, Project Vaccines, and other tangible materials produced under the Project.
4. Changing Project Scope, Timelines or Funding as Outbreak Develops
4.1 Changing Project Scope. The Parties acknowledge the possibility that, as the Outbreak develops in ways not foreseen in the initial Work Package(s), a Project Expansion may become essential. For example, the extent or severity of the Outbreak may increase, the Project Vaccine may be prioritized by public health authorities for clinical studies and/or manufacture or advances in vaccine technology may permit acceleration of the Project. Alternatively, it may become necessary for CEPI to limit Project scope or defer certain activities. For example, the WHO may determine that the Outbreak is no longer a Public Health Emergency of International Concern (“PHEIC”), third party products may be prioritized for development or deployment by an international decision–making process, CEPI may need to focus its resources on other product in its portfolio, or the Project Vaccine may not appear to meet Outbreak response needs.
4.2 Implementing Changes in Project Scope or Timing. At the request of either Party, and as a matter of urgency, the Parties shall discuss in good faith: (i) whether a Project Expansion may be undertaken at CEPI’s cost through modification of an existing Work Package, approval of an additional Work Package or utilization of the Project Continuity Plan in Clause 13; or (ii) how best to limit Project scope or defer certain activities in a Work Package. For clarity, during the Outbreak, CEPI reserves the right to terminate a Work Package if this is necessary in its sole discretion, provided CEPI pays Awardee all costs incurred or obligated to date and including any non–cancellable costs under such Work Package, and also provided that, if requested by CEPI, Awardee shall reasonably demonstrate the incurred, obligated or non–cancellable nature of such costs.
4.3. Participation By Other Funders. Other funders may offer to fund certain parts of a Work Package or a Project Expansion. Additional funding mechanisms may become available to either Party. The Parties shall, in good faith, facilitate such participation and appropriate revisions to relevant Work Packages and the Budget, as well as managing any potentially conflicting commitments.
6. Clinical Studies
6.7 Priority for Clinical Trials. Awardee acknowledges that the pool of subjects available in areas of Outbreak to participate in a clinical trial to test products may be limited. Accordingly, if WHO, CEPI or a regulatory authority in the area where the clinical trial is to be conducted determines that a product other than a Project Vaccine has substantially greater potential and should be prioritized instead for a particular clinical trial, Awardee shall abide by such determination and shall not proceed with a clinical trial of such Project Vaccine unless required to do so by a relevant regulatory authority and Awardee shall be reimbursed for its costs, including non–cancellable costs, incurred resulting from such determination to not proceed.
6.8 Potential WHO Clinical Trials. Awardee shall not unreasonably decline a request to participate in a Phase IIb or III clinical trial as requested by WHO and/or CEPI to compare the Project Vaccine with other COVID–19 vaccine candidates, under a Project Expansion
12. Ready Reserve of Clinical Trial Material
12.1 Ready Reserve. Unless already addressed by a Work Package, CEPI may request that Awardee undertake the manufacturing and maintenance of a Ready Reserve of Clinical Trial Material through an additional Work Package or Project Expansion, which may include doses from consistency batches. For purposes of this Agreement, a “Ready Reserve of Clinical Trial Material” means a quantity of doses for potential use in a clinical trial of the Project Vaccine, which has not yet received a marketing approval. Such Ready Reserve of Clinical Trial Material may be used for further clinical trials, to advance product development and for emergency use subject to the necessary regulatory approvals or consents, in each case in emergency situations based on national or international guidance (such as by the WHO) or in such other manner as CEPI may reasonably determine. An additional Work Package covering such activities shall be negotiated [***] and in good faith by the Parties.
12.2 Management of Ready Reserve. The Parties agree that CEPI may delegate the management of the Ready Reserve of Clinical Trial Material to WHO or other CEPI designee.
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.
14. Equitable Access
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 (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.