4. Project, Standards And Records Management
4.5 Project Records. The Partner shall ensure that all staff and Sub-Contractors working on the Project keep full, detailed and accurate records of all of their activities and results obtained in connection with each Work Package of the Project; including scientific records of all research, development and other work carried out in respect of each Work Package of the Project and the results of such research, development and other work is performed in accordance with GLP, GCP and GMP as applicable and in a way which is appropriate for patenting and regulatory purposes.
4.6 Access to records. Upon CEPI’s request, the Partner shall make available (and shall procure that its Sub-Contractors make available) to CEPI all records generated in connection with any Work Package of the Project (except for any records which at the time of the request should remain blinded to CEPI in the interests of the integrity of a clinical trial).
4.7 Accuracy of data. The Partner shall use Reasonable Effort to ensure that the Data it maintains and reports to CEPI and the JMAG [Joint Monitoring and Advisory Group], are complete, reliable, accurate and not misleading. The provisions in this Clause 4 shall apply mutatis mutandis to Additional Work Packages and Additional Work Package Statements.
9. Clinical Trials
9.4 Data. CEPI may engage one or more Assessors to perform certain assessments and/or meta-analyses of data (at CEPI’s cost) to provide CEPI with directly comparable assessments of equivalent vaccines produced by CEPI’s portfolio of vaccine platforms. The results of the data analysis or other assessments will be subject to the confidentiality and data protection obligations and the limitations of the Public Health License under this Agreement. Upon request, CEPI will provide the results of such data analysis as regards their own data to the Partner. To enable CEPI or its Assessors to conduct such analyses, subject to specific Work Packages, the Partner agrees to take Reasonable Efforts as follows:
9.4.1. to provide data or other information generated by Partner under this Agreement to CEPI’s designated Assessor as CEPI shall request, including without limitation, data regarding CMC, formulation or the results of any of its pre-clinical or clinical trials (duly anonymized and, upon CEPI’s request, blinded);
9.4.2. to provide CEPI’s designated Assessor with other data (duly de-identified and, upon CEPI’s request, blinded) from the Development as CEPI may reasonably request in order to conduct comparative assessments and meta-analyses thereof;
9.4.3. to include language in the informed consent forms used in connection with the use of data or the collection of samples from which such data is derived, granting permissions for such data (duly de-identified) to be used for the purposes indicated in this Clause 9, and also that all such informed consent forms have been approved by any and all appropriate ethical committees or institutional review boards; and
9.4.4. to obtain informed consent from the human subjects vaccinated with the Project Vaccines in clinical trials that gives permission for the use of data (duly de-identified and, at CEPI’s request, blinded) and for the collection of samples from which data is derived (ensure that all requisite informed consent documentation allowing the provision, transportation, use and analysis of data by CEPI or its designated Assessors as indicated in this Clause 9; and also that all such informed consents satisfy the requirements of any and all appropriate ethical committees or institutional review boards.
The provisions in this Clause 9 shall apply mutatis mutandis to Additional Work Packages and Additional Work Package Statements.