3. Use of Funds; Procurement; Project Records
3.7 Financial Reports. Awardee shall provide reports of its expenditures under the Budget with supporting documentation and using a template provided by CEPI (“Financial Reports”) within [***] of a Project’s [***], such other date(s) as may be identified in the Budget. Awardee shall submit a final Financial Report within [***] after the completion of any Work Package.
3.8 Project Records. Awardee shall keep accurate records of its Project activities and expenditures under each Work Package and retain them for [***] after termination of this Agreement.
3.9 Access to Financial Records. During the term and for a period of [***] after expiration or termination of this Agreement, CEPI, or its designee (which shall be a internationally recognized certified public accounting firm, not engaged on a contingent basis), and at CEPI’s reasonable cost, shall have on-site access to inspect Awardee’s Project- related financial records once annually upon at least [***] advance notice. Such inspections shall be conducted during normal operating hours in a manner to minimize disruption to Awardee’s business. For clarity, access to such records also shall be provided to records related to Cost of Goods as described in Clause 14.
3.10. Project Financial Audits. During the term and for a period of [***] after expiration or termination of this Agreement, if requested by CEPI, and at CEPI’s reasonable cost, [***] notice, Awardee’s external auditors shall conduct a Project audit in accordance with ISA800 and/or ISA805 and like standards and provide CEPI with audited statements. Such requests shall not occur more frequently than [***] and will be conducted during normal operating hours in a manner to minimize disruption to Awardee’s business.
10. Independent Assessors
10.1. Independent Assessors. As described in a Work Package or as otherwise reasonably required by CEPI, CEPI may engage one or more independent third-party laboratories or collaborators (“Assessors”), in confidence and at CEPI’s expense, to evaluate Project Results, including the Project Vaccine, in order to provide CEPI with directly comparable evaluations of similar materials produced under CEPI’s portfolio of awarded projects. The results of the testing, analysis, meta-analysis or other assessments shall be subject to the confidentiality obligations under this Agreement. CEPI shall provide to the Awardee access to the results of such analysis or assessment relevant to Awardee’s activities under the Project, including information regarding the methodology of the overall analysis or assessment and rationale for conclusions reached under such analysis or assessment sufficient to give context to such results, as well as reasonable access to discuss the same with any such Assessors. For clarity, one of CEPI’s assessors is the Task Force for Global Health and its SPEAC team of vaccine safety experts.
10.2. Awardee Cooperation. Awardee shall provide reasonable assistance to CEPI and any designated Assessor, including:
(a) 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.
(b) cooperate in regard to data analysis, to the extent relevant under a given Work Package, by CEPI’s Assessor 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) and other documents and information such as study protocols, case report forms needed to develop standardized approaches and tools for safety data management;
(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 trial data (duly de- identified and, at CEPI’s request, blinded) for the purposes of signal detection or meta-analyses of safety data (including across product candidates).
14. Equitable Access
14.4. Pandemic Period Production and Supply. During the Pandemic Period, Awardee shall:
(b) provide the JMAG with a regularly updated [***] statement of its actual capacity and a forecast of its planned capacity for manufacturing of Project Vaccine;
(c) provide the JMAG with [***] advance written notice of each manufacturing run for the Project Vaccine;
(e) discuss in good faith with JMAG how to achieve its requirements for doses of Project Vaccine, including any potential increase in Awardee’s manufacturing capacity.
14.7. Costs and Sales. Consistent with the commitments in Clauses 14.4 to 14.6, Awardee shall:
(a) provide written [***] updates to the JMAG regarding its COGs for Project Vaccines and discuss relevant product development decisions that could affect COGs; and
14.8. Information about Production, Supply, Pricing and Sales. Upon written request by CEPI, Awardee shall provide reasonable information about its COGs, production, supply, pricing and sales of Project Vaccine sufficient to evaluate whether such activities meet the Equitable Access Policy.
14.9. Audit of Cost of Goods. No more than [***] and at CEPI’s reasonable cost, CEPI shall have the right to review or to designate an external auditor (which shall be an internationally recognized certified public accounting firm, not engaged on a contingent basis) to review Awardee’s financial records relevant to the information provided in Clause 14.8. Such audits will be conducted during normal operating hours in a manner to minimize disruption to Awardee’s business. In event that the audit concludes that the COGs and production, allocation, supply or pricing of Project Vaccine doses are not substantially in accordance with the achievement of Equitable Access as described in Clause 14.1, then Awardee shall: [***]. The provisions of this Clause 14.9 shall apply to any Sub-Grant Awardees and Trusted Collaborators.