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 one of either the WHO or the Paul-Ehrlich- Institute (PEI) in Germany or, if agreed by the Parties, another independent standards development agency.
9.2 Assay Development. A Work Package may include the development of assays (including immunogenicity and potency/release assays), as will be described in the IPDP.
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 (in whole or in part) or with the use of samples or biological material facilitated by CEPI. Transfer capacity and technology relating to such assays to a designated, independent third party laboratory if required by CEPI for the assay to be validated for Phase 3 clinical trials. If and to the extent any SOPs incorporate Trade Secret Information or Confidential Information within Awardee Background IP, CEPI will maintain the confidentiality of such information in accordance with Clause 22.4 and Awardee and the designated third party laboratory shall first enter into a customary confidentiality agreement with Awardee governing the use and non-disclosure of such information, provided that Awardee and such third party laboratory shall not delay the execution of such agreement.
10. Project Results and their Ownership
10.3 The Awardee will:
a. record Project Results accurately, completely and reliably in Awardee’s IPDP Records; and
b. identify Project Results in the IPDP Reports provided to the JMAG [Joint Monitoring & Advisory Group].
11. Dissemination and Publication of Project Data
11.1 Reporting of Project Data. Subject to the confidentiality provisions contained in Clause 22.4, Awardee shall provide CEPI with access to all data and information, including all pre-clinical and clinical study data, produced or arising as a result of the Project (“Project Data”), and will report Project Data regularly to the JMAG. Notwithstanding the foregoing, with respect to Project Data produced or arising as a result of the Awardee- Funded Study, Awardee shall provide summaries of such Project Data to the JMAG and, at CEPI’s request (including through CEPI’s members of the JMAG), Awardee shall provide additional information and details relating to such Project Data as reasonably requested by CEPI.
11.7 The Awardee will:
a. notify the JMAG on an ongoing basis as Project Data is produced and disseminated in accordance with Clause 11.1;
b. disseminate Project Data consistent with the requirements set out above in this Clause 11; and
c. cooperate in regard to data analysis, to the extent relevant under a given Work Package, by CEPI’s Assessors, subject to Clause 22.4, by: i. providing data or other information generated under this Agreement to CEPI’s designated Assessor as CEPI may reasonably request, including data regarding 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 of Project Materials
12.1 Dissemination and Sharing of Project Materials. Awardee will share with CEPI Project Materials produced under the Project. CEPI undertakes to keep the Project Materials confidential in accordance with the terms of Clause 22.4. For purposes of this Agreement, “Project Materials” means the drug product and the clinical trial materials described in Clause 12.3 (c) (ii). [***].
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 as specified under Clause 12.3c, at CEPI’s expense, in order to provide CEPI with directly comparable evaluations of similar materials produced under CEPI’s portfolio of awarded projects. All such Assessors shall be bound by confidentiality obligations at least as stringent as those contained in Clause 22.4. CEPI shall inform Awardee through the JMAG about potential Assessors prior to their engagement by CEPI. CEPI may not engage Awardee Competitors as Assessors without Awardee’s consent, such consent not to be unreasonably withheld, delayed or conditioned. [***]. 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 (“Results”) will be subject to the confidentiality obligations under this Agreement. CEPI will provide to the Awardee the Results as are relevant to Awardee’s activities under the Project. In no event will CEPI publish or otherwise disclose any Results without Awardee’s consent, such consent not to be unreasonably withheld, delayed or conditioned.
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 in this Clause 12; and
c. cooperate with CEPI’s Assessor, to the extent relevant under a given Work Package, subject to Clause 22.4, by: i. providing CEPI’s designated Assessor a reasonable number of doses of a candidate vaccine (Product) 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 (excluding the Awardee-Funded Study) 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 (excluding subjects vaccinated in Awardee’s Phase 1 clinical trial completed prior to the Effective Date or in the Awardee- Funded Study) 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 (containing, among other terms, confidentiality and use restrictions) to be entered into between Awardee and the Assessor in addition to any other applicable laws and regulations.