12.1 Dissemination and Sharing of Project Materials. Awardee will share biological samples, vaccines (including Product), animal models and other tangible materials produced under the Project (together “Project Materials”) as described in the IPDP and this Agreement.
12.2 Comparative Evaluation of Samples. CEPI may engage one or more independent third party laboratories or collaborators (“Assessors”) to perform additional testing on Project Materials, at CEPI’s expense, in order to provide CEPI with directly comparable evaluations of similar materials produced under CEPI’s portfolio of awarded projects. CEPI may, in its sole discretion and at its own expense, also engage certain independent third party entities to transport the samples from Awardee to the Assessor, address import/export issues, or provide any documentation CEPI may determine is required for such samples. The results of the testing, analysis, meta-analysis or other assessments will be subject to the confidentiality obligations under this Agreement. CEPI will provide to the Awardee the results of such data analysis relevant to Awardee’s activities under the Project.
12.3 The Awardee will: (a) notify the JMAG on an ongoing basis as Project Materials are produced under the IPDP; (b) disseminate and share Project Materials consistent with the requirements set out above; and (c) cooperate with CEPI’s Assessor, to the extent relevant under a given Work Package, by: (i) providing CEPI’s designated Assessor a reasonable number of doses of a candidate vaccine, as specified in the IPDP, representative of the final Product, for animal immunogenicity studies; (ii) providing CEPI’s designated Assessors with an agreed number of samples from clinical studies under the Project for use in future research carried out by or on behalf of CEPI including agreed volumes of biological samples (for example, serum, and peripheral blood mononuclear cells (PBMCs)) from human subjects vaccinated with the Project vaccines in Phase 1 clinical trials at specified timepoints agreed with CEPI for immunology testing; and (iii) ensuring that any samples to be transferred or exported by or on behalf of Awardee from a clinical trial site or sample storage site are transferred and/or exported pursuant to the terms and conditions of a suitable to-be-agreed-upon material transfer agreement to be entered into between Awardee and the Assessor in addition to any other applicable laws and regulations.