Provision Language
5. Financial Management and Oversight
[This Clause 5 explains financial management and oversight practices. As an ethical organization and as the recipient of funds from several governments, CEPI follows good management practices including transparent and well–controlled procurement and prudent anti–corruption principles and observes international sanctions. Accordingly, for example, CEPI will reimburse only travel expenses in line with CEPI’s travel policy.]
5.1 Financial Practices. Awardee’s financial management of the Project will be governed by controls, good management practices, procedures and standards at least as rigorous as its local Generally Accepted Accounting Principles (GAAP), or International Financial Reporting Standards (IFRS) if adopted by the Awardee, as confirmed in Awardee’s annual audited financial statement.
5.2 Financial Oversight. CEPI, or its designee, will have on–site access to Awardee’s Financial Records at least annually, including at such times as CEPI may request provided CEPI has given not less than five (5) Business Days’ notice, in order that CEPI may monitor Awardee’s expenditure of Project funds.
5.3 The Awardee will:
a. keep accurate, complete and reliable records of revenues and expenditures under the Project Budget (“Financial Records”) against an individual project code;
b. retain all Financial Records for seven (7) years after termination or expiry of the Project or for any longer period as required by law or Awardee’s own policies and allow CEPI access to such records as set out in Clause 5.2 for such retention period;
9. Standards and Assays
[Some Projects may involve the sourcing of samples or other materials and the development of assays and biological standards, and this Clause 9 describes relevant obligations. Additional provisions for such Project activities will be included. This clause may not be relevant to all Project awards.]
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.
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.
10. Project Results and their Ownership
[This Clause 10 confirms that Awardee owns its Project Results. Several Clauses that follow explain how Project Results will be published and shared.]
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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.
11. Dissemination and Publication of Project Data
[This Clause 11 describes how Project Data, including clinical study data, should be disseminated. CEPI’s Scientific Integrity Policy and Clinical Trials Policy are pertinent.]
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.
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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
[This Clause 12 describes how Project Materials, including biological samples, should be disseminated.]
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.
13. Intellectual Property
[This Clause 13 describes the treatment of IP rights that arise under the Project or that are owned by third parties and may affect the Project. Generally, CEPI’s interest in IP is knowing what IP has been developed with CEPI funding and having rights under that IP sufficient to utilize the Public Health License described in Clause 17.]
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13.3 The Awardee will:
a. notify the JMAG as Project IP is created, discovered or made; any applications for any rights to Project IP are submitted or are otherwise prosecuted; any application regarding the registration of any Project IP is granted, including the granting of any patent or trade mark, as part of its regular IPDP reports; and
b. ensure that it has enforceable policies or written agreements with all of its employees, agents and subcontractors which assign to the Awardee ownership of all Project IP.