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. [“Work Package(s)” means a discrete set of activities in an iPDP as identified in Annex C. Additional Work Package(s) may be agreed to by the Parties after the Effective Date, which, upon execution by both Parties, shall be annexed to and become a part of this Agreement.]
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 [Integrated Product Development Plan].
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.
13.3 Alternative Designations by CEPI. If Awardee does not designate a Trusted Collaborator and/or Trusted Manufacturer, or they notify 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.