6. Clinical Trials
6.1 Clinical Trials. Awardee shall undertake the clinical trials as described in the clinical development plan in the iPDP (the “Project Clinical Trials”), in compliance with all applicable laws and regulations, including requirements related to use of clinical data outside of the country in which a given Project Clinical Trial is conducted. Awardee shall ensure that all Project Clinical Trials comply with CEPI’s Clinical Trial Policy referred to in Clause 11.2.
6.2 Clinical Trial Protocols: Preparation. Awardee shall be responsible for the preparation of clinical trial protocols for the Project Clinical Trials. Awardee shall provide CEPI and/or CEPI’s designee with a draft of each clinical trial protocol for the Project Clinical Trials and shall consult with and consider any reasonable suggestions made by CEPI and/or its designee regarding the clinical trial protocols reasonably in advance of finalising the relevant clinical trial protocol and submitting it to the institutional review boards, ethics committees, and/or regulatory authorities.
6.3 Clinical Trial Protocols: Reporting of Submitted Versions. Awardee shall provide to CEPI a copy of all clinical trial protocols as submitted to institutional review boards, ethics committees and regulatory authorities in respect of the Project Clinical Trials.
6.4 Clinical Data. Informed consent shall be obtained from each clinical trial subject to allow, to the extent permitted by law: (a) the transfer of anonymised or pseudonymised data to CEPI and/or CEPI’s designee; and (b) the collection and use of biological samples and the use of data (duly anonymised or pseudonymised (at CEPI’s discretion) and, at CEPI’s request, blinded) derived from such samples by CEPI or its designated Assessors (as defined herein) for the purposes of this Agreement.
6.5 Sponsorship and Management of Clinical Trials.
(a) 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 and ethical committee approvals necessary or reasonably useful for the conduct of the Project Clinical Trials.
(b) In respect of each Project Clinical Trial, Awardee shall establish an internal Trial Steering Committee (“TSC”) and either a Safety Monitoring Committee or Data Safety Monitoring Board, as applicable (each, a “DSMB”). CEPI shall be entitled to appoint, and Awardee shall permit, a CEPI representative or designee to attend all meetings of each Project Clinical Trial’s TSC and/or DSMB as an observer (either in person or by telephone, video or other electronic means). Subject to Clause 6.5(c) below, Awardee shall provide a copy to CEPI of all papers that a member of the TSC and/or DSMB would be entitled to receive at the same time as any such papers are provided to the members of the TSC and/or DSMB (as applicable).
(c) In the event that CEPI’s attendance at a meeting of the TSC and/or DSMB or receipt of papers would, in the Awardee’s reasonable discretion acting in good faith, jeopardise the integrity/blinded nature of an ongoing Project Clinical Trial, the Awardee shall promptly notify CEPI of such fact and CEPI shall not be entitled to, and Awardee shall not be required to permit CEPI to, attend such meeting or receive such papers at that time. During an ongoing Project Clinical Trial, Awardee will continue to provide CEPI with all open session DSMB documents, DSMB recommendation forms and other “open” documents identified by both Parties in the iPDP and/or protocol for such Project Clinical Trial. After a Project Clinical Trial l is unblinded, Awardee shall provide a copy of all papers that were provided to the members of the TSC and/or DSMB and/or that a member of the TSC and/or DSMB would be entitled to receive.
6.6 Safety Notifications. Awardee shall notify the JMAG in writing promptly 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 within 48 hours from the time when such event or series of events becomes known to Awardee.
6.7 Records and Reporting. Awardee shall ensure that all data in relation to the Project Clinical Trials and any other clinical trials undertaken by or on behalf of Awardee or Subawardee with respect to the Project Vaccine are appropriately recorded and that all such records are kept up to date and maintained in accordance with applicable laws and regulations. Awardee will ensure that CEPI is able to review and verify all anonymised or pseudonymised data at the end of the relevant Project Clinical Trial or other clinical trial and will promptly following the end of such Project Clinical Trial or such other clinical trial provide a copy of, or access to, such anonymised or pseudonymised data to CEPI in such form as CEPI may reasonably require.
6.8 Priority for Clinical Trials. Awardee acknowledges that the pool of subjects available in areas of Outbreak to participate in a clinical trial to test the Project Vaccine 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 prioritised instead for a particular clinical trial, Awardee shall not unreasonably proceed with a clinical trial of such Project Vaccine unless required to do so by a relevant regulatory authority or a Pre–existing Agreement. Awardee shall be reimbursed for its reasonable, non–cancellable costs incurred resulting from such determination to not proceed.
6.9 Potential WHO Clinical Trials.
(a) Awardee shall not unreasonably decline to participate in a Phase IIb or III clinical trial as requested and funded by WHO and/or CEPI to compare the Project Vaccine with other COVID–19 vaccine candidates.
(b) In the event of such participation by Awardee, Awardee will, promptly following the end of such clinical trial, provide a copy of the final study report to CEPI.
7 Regulatory Activities
7.1 Regulatory Activities. Awardee shall pursue the regulatory activities described in the iPDP.
7.2 Meetings with Regulatory Authorities. Awardee shall notify CEPI in writing of any material meetings with regulatory authorities at least five (5) Business Days in advance of such meetings, or if Awardee itself receives less than five (5) Business Days notice of such a meeting, as soon as practicable. CEPI or its designee may, at CEPI’s option, observe all material interactions between Awardee and regulatory authorities relating to the Project Vaccine. At CEPI’s reasonable request, Awardee shall request a meeting with regulatory authorities to address 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 material regulatory submissions for review and comment by CEPI no later than ninety–six (96) hours prior to their contemplated submission to a regulatory authority. If a final version is not available by ninety–six (96) hours prior to submission, then a mature draft version may be electronically delivered to CEPI for review at that time. Additionally, Awardee shall upload copies of the following to 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 or routine 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 including official meeting minutes.