“Increased Outbreak Preparation Need” means when, having considered all reasonably accessible and relevant information including epidemiological data, travel and migration patterns and the likely availability of other products or product candidates, CEPI determines, in its sole discretion, that there is a heightened need for a Product.
“Outbreak” means a Public Health Emergency of International Concern declared by WHO or a public health emergency on a national or regional scale declared by one or more national governments, in each case as a result of a material increase in the number of cases of people infected with CHIK or RVF including any regional out–break, an epidemic or a pandemic.
7. Clinical Studies
[Some Projects may involve clinical studies, and this Clause 7 describes relevant compliance obligations in addition to the conditions given under Clause 6. Some of the “consent” requirements described here are necessary for enabling some of the data and sample access procedures described in Clauses 11 and 12.]
7.3 Priority for Clinical Studies. Awardee acknowledges that the pool of subjects available in areas of Outbreak to participate in a clinical study to test products such as the Product may be limited. Accordingly, if CEPI determines that a product other than the Awardee’s Product has substantially greater potential and should be used for a particular clinical study, the Awardee agrees that it shall abide by such decision and will not proceed with a clinical study of the Product unless agreed with CEPI.
16. Preparation for Outbreaks
[This Clause 16 explains that Awardee may be requested to undertake additional Product–related work at CEPI’s expense, consistent with the provisions of Equitable Access. If Awardee is unable or unavailable to do so, CEPI would prefer that Awardee designate a trusted collaborator to complete this work. The definition of “Outbreak” reflects the WHO definition and may be triggered by WHO or declarations by governments in an affected area.]
16.1 Outbreak. CEPI will notify Awardee in writing in the event of an Outbreak (“Outbreak Notice”) or if there is an Increased Outbreak Preparation Need (defined as, “when, having considered all reasonably accessible and relevant information including epidemiological data, travel and migration patterns and the likely availability of other products or product candidates, CEPI determines, in its sole discretion, that there is a heightened need for a Product”). In consultation with relevant public health authorities, CEPI may request that Awardee discuss in good faith whether and how the Project Results could be utilized in response to the Outbreak Notice. Once an Outbreak Notice has been provided, CEPI shall have the right to direct how any Product manufactured pursuant to Clause 16.3 may be used and to whom it may be provided.
16.2 Additional Product Development. Pursuant to an Outbreak Notice, CEPI may request that Awardee undertake additional Product development at CEPI’s expense or other activities, including the pursuit of regulatory approvals and licensure. An additional Work Package covering these activities will be negotiated expeditiously and in good faith by the Parties.
16.3 Investigational Product Stockpiles. Following the successful completion of a Phase 2 clinical study supported under the Project, CEPI may request that Awardee undertake, at CEPI’s expense, the manufacturing of a stockpile of Investigational Product. Such Product may be used for further clinical trials in Outbreak conditions to advance vaccine development, or pursuant to an emergency use authorization, in each case in emergency situations based on national or international guidance (such as WHO). An additional Work Package covering this activity will be negotiated expeditiously and in good faith by the Parties.
16.4 Trusted Collaborator. At the time that Awardee submits a Phase 2 study report to CEPI (or at any earlier time), Awardee will propose a third party, for example, a Sub–Awardee, as a preferred alternative to itself (“Trusted Collaborator”), that is capable of performing the work and would be prepared to undertake activities pursuant to Clauses 16.2 or 16.3 in the event that Awardee declines CEPI’s request to do so, or if Awardee and CEPI do not reach agreement on a new Work Package. Alternatively, CEPI may propose a Trusted Collaborator to Awardee. Neither Party may unreasonably decline to accept the designation of a proposed Trusted Collaborator.
16.5 Technology Transfer. As described in the IPDP, or otherwise upon designation of a Trusted Collaborator pursuant to Clause 16.4, Awardee will promptly and diligently provide all necessary guidance, information, materials and assistance reasonably required by the Trusted Collaborator to accomplish the activities that may be requested by CEPI under Clauses 16.2 or 16.3 (“Technology Transfer”) at CEPI’s reasonable cost.
16.6 The Awardee will: cooperate with CEPI in developing a response to an Outbreak or Increased Outbreak Preparation Need which may include opportunities for Awardee and its Sub–Awardees to receive additional Work Packages and funding from CEPI.