6. Clinical Studies
6.4 Sponsorship and Management of Clinical Trials. Awardee shall be the sponsor of any clinical trial (unless CEPI and Awardee otherwise agree in writing), and shall be responsible for obtaining and maintaining all regulatory approvals (including ethical committee approvals) necessary or reasonably useful for the conduct of the clinical trial. In addition, Awardee shall establish an internal Trial Steering Committee (TSC) and a Safety Monitoring Committee or Data Safety Monitoring Board, as applicable (either, a DSMB). Awardee shall, consistent with DSMB charter documents, permit a CEPI representative or designee to: (i) attend meetings of DSMB for the clinical trial as an observer (either in person or by electronic means); and (ii) receive all papers that a member of the DSMB would be entitled to receive. The foregoing obligation shall not apply to the extent CEPI’s attendance at a meeting or receipt of papers would jeopardize the integrity/blinded nature of an ongoing clinical trial; during an ongoing clinical trial, Awardee will provide CEPI open session DSMB documents, DSMB recommendation forms and other “open” documents and after a clinical trial is unblinded, CEPI may receive papers that a member of DSMB would be entitled to receive.
6.5. Safety Notifications. Awardee shall notify the JMAG in writing [***] following any single safety event of concern or a series of safety events considered by the DSMB as relevant in relation to the Project Vaccine and at least within [***] after such event or series of events becomes known to Awardee.
7. Regulatory Activities
7.1 Regulatory Activities. Awardee shall pursue the regulatory activities described in the iPDP and associated Work Package(s).
7.2 Meetings with Regulatory Authorities. Awardee shall invite a CEPI or its designee to observe all material interactions between Awardee and regulatory authorities relating to a Project Vaccine. At CEPI’s reasonable request, Awardee shall request a meeting with regulatory authorities to deal with any significant unresolved issues.
7.3 Regulatory Filings. Awardee shall consult regularly with CEPI regarding regulatory strategy for a Project Vaccine and shall provide advance copies of all regulatory submissions for review and comment by CEPI no later than [***] prior to their contemplated submission to a regulatory authority. If a final version is not available by [***] prior to submission, then a mature draft version can be submitted to CEPI for review at that time. Additionally, Awardee shall put copies of the following on a confidential electronic archiving service designated by CEPI:
(a) all submissions to regulatory authorities and regulatory filings in respect of a Project Vaccine together with all data included or referenced therein (other than ministerial submissions that do not involve safety or efficacy issues); and
(b) material documents and information exchanged between any regulatory authority and the Awardee relating to a Project Vaccine.
7.4 Product Development Standards. To the extent applicable to the Project, Awardee shall comply with Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices.
7.5 Other Access and Cross References. Awardee shall provide access to other regulatory files and records in good faith and as appropriate to achieve the objectives of this Agreement. For clarity, this may include permission to cross reference master files related to the platform on which the Project Vaccine is produced.