Provision Language
2. Project Organization and Management
2.1 IPDP and Work Packages. The Awardee’s Project activities, which are intended to further develop a Chikungunya Vaccine are set out in the Integrated Product Development Plan (IPDP), which may be found in Annex C. Awardee will use commercially reasonable endeavours to achieve the associated deliverables, milestones and timelines of each Work Package and achieve agreed upon Technical Review criteria by the agreed deadline (the “Technical Review Point“) set forth in Annex C. In accordance with Clause 4.6 below, additional Work Package(s) may be agreed in writing by the Parties after the Effective Date, which, upon execution by both Parties, shall be annexed to and become a part of this Agreement. Work Packages may also be modified or extended with the mutual written consent of both Parties in accordance with Clause 24.14.
2.2 Technical Reviews. Awardee will notify the JMAG when it is reasonably assured that a Technical Review Point will be achieved in the near term, and promptly provide the JMAG with relevant information and agreed upon data. [***]
4. Project Funding and Work Package Streams
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4.9 The Awardee will:
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b. provide a financial report to CEPI within [***] of the end of each six (6) month period during the Term of the Project, regarding its expenditures pursuant to the Project Budget, using the template provided in Annex F. In the first Financial Report Awardee willinclude details of its expenditures incurred in the period from the Pre-Activities Start Date until the date of the first Financial Report;
c. provide a separate final financial report for a work package within [***] after the completion of any Work Package;
5. Financial Management and Oversight
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5.2 Financial Oversight. Subject to the confidentiality provisions contained in Clause 24.4, CEPI, or its designee, will have on-site access to Awardee’s Financial Records annually, 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 annually 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. from the Pre-Activities Start Date, keep accurate, complete and reliable records of revenues and expenditures for the period between the Pre-Activities Start Date and 30 June 2024 as set forth in the relevant section of Annex E;
b. from the effective date, keep accurate, complete and reliable records of revenues and expenditures under the Project Budget (“Financial Records“) against an individual project code;
c. retain all financial records and details of the pre-activities start date expenditure 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;
d. provide [***] written notice to CEPI before destroying financial records;
e. 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;
f. if requested by CEPI, awardee will permit awardee’s external auditors or an independent audit firm appointed by CEPI to conduct a Project audit (on and off site). The audit will be conducted at CEPI’s reasonable cost and expense;
g. procure a project audit as identified above from sub-awardees at CEPI’s request and at CEPI’s reasonable cost and in accordance with relevant audit and assurance standards, including but not limited to, ISA800 or ISRS4400; and
h. provide information required by the European communities court of auditors and anti-fraud office.
6. Compliance with Applicable Laws and CEPI Policies and Procedures
6.2 CEPI’s Third Party Code. The third party Code is a statement of CEPI’s values and of the policies, practices and principles applicable to recipients of CEPI funding. Awardee:
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d. will cooperate as may be reasonably requested by CEPI in the submission of information related to Project activities and expenditures in accordance with the International Aid Transparency Initiative (Section 12 of the Code); and […]
10. Standards and Assays
10.1 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.
13. Dissemination and Publication of Project Data
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13.1 Reporting of Project Data. Subject to the confidentiality provisions contained in clause 24.4, 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 any 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.
14. Dissemination of Project Materials
14.1 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 24.4. For purposes of this Agreement, “Project Materials” means the drug product and the clinical trial materials described in Clause 14.4 (c) (ii). For clarity, “Project Materials” shall not include any intermediates or assays relating to the manufacturing process.
14.2 Comparator Samples. The awardee will use commercially reasonable endeavours to make a limited amount of samples of marketed Product and/or Product in use under emergency use license available as comparator for other research in the Field, if reasonably justified by requestor under terms and conditions (including but not limited to the scope of research, protocol and reporting) agreed between the Parties, with the spirit to advance research in the Field.
14.3 Comparative Evaluation of Samples. CEPI may engage one or more independent third party laboratories or collaborators (“Assessors“) (which may include but is not limited to the Task Force for Global Health and its Safety Platform for Emergency vACcines (SPEAC Project)) to perform additional testing on Project Materials as specified under Clause 14.4c, 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 24.4. 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. Awardee shall have the right to veto the engagement of an Awardee Competitor that CEPI seeks to appoint as an Assessor. CEPI may appoint any other third party as an Assessor provided that, if Awardee raises reasonable objections to the appointment of an Assessor (other than an Awardee Competitor), the matter shall be submitted to the JMAG for decision. If the JMAG is unable to decide, then the escalation process according to Clause 23.1 shall apply. 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.
14.4 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 14; and
c. cooperate with CEPI’s assessor, to the extent relevant under a given work package, subject to Clause 24.4, 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 biological samples from clinical studies under the Project funded by CEPI and provided such clinical studies collects biological specimen as samples, (excluding 1) the Awardee-Funded Study and 2) the completed Phase 3 clinical study VLA1553-301) 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 participants 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.
15. Intellectual Property
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15.3 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 trademark, as part of its regular IPDP reports;
16. Equitable Access
16.5 Information about Production, Supply, Pricing and Sales.
16.5.1 Upon written request by CEPI, Awardee will provide, and will procure that its Sub-Awardees, LMIC Manufacturers and Trusted Collaborator provides, reasonable information about its production, supply, pricing and sales of Product, including its audited financial statements sufficient to enable CEPI to evaluate whether such activities are consistent with Awardee’s obligations under this Agreement.
16.5.2 Awardee shall ensure that its Sub-Awardee Instituto Butantan provides CEPI with updates on Sub-Awardee’s pricing discussions with relevant pricing authorities within Brazil and the other Non-Traveler’s Market Countries awarded to Butantan, including public sector procurement agencies such as AVAT, GAVI, PAHO, and various Ministries of Health, as applicable. Further, Sub-Awardee shall share with CEPI any official pricing data submitted to CMED and CONITEC in Brazil and to other relevant pricing authorities outside of Brazil.
