5. Financial Management and Oversight
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. Subject to the confidentiality provisions contained in Clause 22.4, CEPI, or its designee, will have on–site access to Awardee’s Financial Records [***], at such times as CEPI may request, provided CEPI has given not less than [***] notice, in order that CEPI may monitor Awardee’s expenditure of Project funds. CEPI or its designee will have such on–site access to Awardee’s Financial Records more than [***] in the following circumstances:
i. where CEPI has reasonable grounds indicating that the Awardee is in material breach of this Agreement or has misapplied CEPI Funding; and
ii. where required in the context of an audit of CEPI by one or more of its funders.
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 [***] 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;
c. provide [***] written notice to CEPI before destroying Financial Records;
d. provide up–to–date audited financial statements, as requested by CEPI, and relevant extracts from the auditors’ report for such financial statement as well as the management letter to the auditors;
e. if requested by CEPI, Awardee will procure Awardee’s external auditors to conduct a Project audit (on and off site) and provide CEPI with audited statements regarding the Project Budget (in accordance with ISA800) at CEPI’s reasonable cost and expense;
f. procure a Project audit as identified above from Sub–Awardees at CEPI’s request and at CEPI’s reasonable cost and expense; and
g. provide information required by the European Communities Court of Auditors and Anti–Fraud Office.
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.
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.
13. Intellectual Property
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; […]
15.5 Awardee shall keep, and cause its Affiliates and sublicensees to keep, complete and accurate records relating to all Net Sales and by [***] in each year following launch of the Product, shall provide CEPI with a report setting out the amount of Net Sales made in the previous calendar year. CEPI shall, upon reasonable notice to Awardee, be entitled to send an independent auditor at CEPI`s cost, who shall be under obligations of confidentiality no less onerous than those set out in this Agreement, to access and review all documents, information, data and materials in the possession of Awardee directly relating to the calculation of Net Sales. If the review of such records reveals that Awardee has failed to accurately report information pursuant to this Clause 15.5 or to make any payment (or portion thereof) required under this Clause 15.5, then Awardee shall pay, within [***] after receipt of a written request, any underpaid amounts due under this Clause 15.5 together with interest thereon applied to the period from the date the amount should have been paid to the date it is actually paid at an interest rate equal to [***]. In the event the review reveals an underpayment of [***] or more of the amounts due under this Clause 15.5, Awardee shall pay all reasonable costs incurred in conducting such review. In the event the review reveals an underpayment of less than [***], then all costs incurred in conducting such review shall be borne by CEPI.