9. Standards and Assays
9.1 Standards Development. If any Work Package relates to the development of biological reference materials, Awardee will provide relevant materials and data and shall grant rights to their use for International Standards development, to an independent standards development agency, such as the National Institute for Biological Standards and Control (NIBSC) in the United Kingdom, as CEPI may direct.
9.2 Assay Development. A Work Package may include the development of assays (including immunogenicity and potency/release assays) intended for use by CEPI’s awardees in the CfP3 Programme, as will be described in the IPDP [Integrated Product Development Plan].
9.3 The Awardee will: a. as described in the IPDP, participate in collaborative interlaboratory studies for evaluation of a candidate reference material. Such studies ultimately will be included in reports to the WHO Expert Committee on Biological Standardization; and b. provide written Standard Operating Procedures (“SOPs”) for any assays developed and qualified with CEPI funding or with the use of samples or biological material facilitated by CEPI. Transfer assay capacity and technology to a designated third party laboratory if required by CEPI for the assay to be validated for Phase 3 clinical trials.
11. Dissemination and Publication of Project Data
11.1 Reporting of Project Data. Awardee shall provide CEPI with access to all data and information, including all clinical study data, produced or arising as a result of the Project (“Project Data”), and will report Project Data regularly to the JMAG.
11.7 The Awardee will: (a) notify the JMAG on an ongoing basis as Project Data is produced and disseminated; (b) disseminate Project Data consistent with the requirements set out above; and (c) cooperate in regard to data analysis, to the extent relevant under a given Work Package, by CEPI’s Assessors by: (i) providing data or other information generated under this Agreement to CEPI’s designated Assessor as CEPI shall request, including data regarding CMC, formulation or the results of any of its pre-clinical or clinical trials (duly anonymized and, upon CEPI’s request, blinded); (ii) providing CEPI’s designated Assessor with other data (duly anonymised and, upon CEPI’s request, blinded) as CEPI may reasonably request in order to conduct comparative assessments; and (iii) providing CEPI’s designated Assessor with clinical study data (duly de-identified and, at CEPI’s request, blinded) for the purposes of signal detection or meta-analyses of safety data (including across candidate vaccines).
12. Dissemination and Publication of Project Materials
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.