Master Alliance Provisions Guide (MAPGuide)

CEPI – VBI, COVID-19 Vaccine Development Funding Agreement

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2. Project Organisation and Management

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2.4 Technical Reports and Access to Project Results. Awardee shall disclose all Project Results to CEPI’s Project Lead, at meetings of the JMAG and shall provide written reports of progress made under the iPDP using a template provided by CEPI (“Technical Reports”), within twenty (20) Business Days of the end of each calendar quarter during the term of the Project as set out in the iPDP. In addition, the Awardee shall make Project Results available to CEPI as described in the iPDP or otherwise as may reasonably be requested from time to time by CEPI.

3. Use of Funds; Procurement; Project Records

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3.8 Financial Reports. Awardee shall provide reports of its expenditure under the Budget with supporting documentation and using a template provided by CEPI (“Financial Reports”) within thirty (30) Business Days of the end of each calendar quarter during the term of the Project or such other date(s) as may be identified in the Budget. Awardee shall submit a final Financial Report for a Work Package within sixty (60) days after the completion of any Work Package.

3.9 Project Records. Awardee shall keep accurate records of its Project activities and expenditure under each Work Package and retain them for a period of five (5) years from the end of the term of the applicable Project.

3.10 Access to Financial Records. During the Term and for a period of five (5) years after expiration or termination of this Agreement, CEPI, or its designee (which shall be an internationally recognised 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 fifteen (15) Business Days’ advance written notice. Such inspections shall be conducted during normal operating hours in a manner to minimise disruption to Awardee’s and/or Sub-Grantee’s business. For clarity, access to such records also shall be provided to records related to Cost of Goods as described in Clause 15.

3.11 Project Financial Audits. During the Term and for a period of five (5) years after expiration or termination of this Agreement, if requested by CEPI, and at CEPI’s reasonable cost, once annually upon at least fifteen (15) Business Days’ 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 inspections shall be conducted during normal operating hours in a manner to minimise disruption to Awardee’s business.

5. Ownership of Project Results; Intellectual Property

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5.2 Ownership of Project Intellectual Property. Awardee shall own any Intellectual Property invented by either Party and arising under the Project, subject to the rights of CEPI to use Project Intellectual Property expressly set out in this Agreement. Awardee shall have the right, but not the obligation, to seek IP protection in respect of any Project Intellectual Property at its own cost. Upon request, but no less than annually, Awardee shall provide a written update to CEPI regarding the status of Project Intellectual Property rights sought and obtained.

10. Independent Assessors

10.1 Independent Assessors. As required in a Work Package or as otherwise reasonably requested by CEPI, Awardee shall cooperate with and provide reasonable assistance to independent third-party laboratories or consultants (“Assessors”) (which may include but is not limited to the Task Force for Global Health and its Safety Platform for Emergency vACcines (SPEAC) Project), retained in confidence and at CEPI’s expense, to consult on development of clinical trial protocols, explore development strategies, and evaluate Project Results, including the Project Vaccine. Awardee acknowledges that such Assessors may provide CEPI with directly comparable evaluations of similar materials developed under CEPI’s portfolio of awarded projects. The results of the testing, analysis, meta-analysis or other assessments by such Assessor(s) shall be subject to the confidentiality obligations of this Agreement. At Awardee’s reasonable request, CEPI shall provide Awardee with access to the results of any evaluation of Project Results by an Assessor solely to the extent such assessment directly relates to the Project Results and Project Vacine. For clarity, CEPI shall not be required to grant access to any information regarding CEPI’s portfolio of other awarded projects.

10.2 Awardee and the Assessor(s) may, at their own discretion, enter directly into an appropriate agreement between themselves to the extent necessary to facilitate any Assessor’s activities under Clause 10.1, such as a non-disclosure agreement or material transfer agreement. CEPI shall, through the JMAG or otherwise, discuss with Awardee protocols and data management related to any Assessor’s activities under Clause 10.1.

10.3 Awardee Cooperation. Awardee shall provide reasonable assistance to CEPI and any designated Assessor to facilitate any Assessor’s activities under Clause 10.1, 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 material transfer agreement to be entered into between Awardee and the Assessor in a form reasonably acceptable to CEPI, the Awardee and the Assessor, in addition to any other applicable laws and regulations.

(b) cooperating with regard to any data analysis, to the extent relevant under a given Work Package or otherwise reasonably requested by CEPI by:

(i) providing data or other information generated under this Agreement to CEPI’s designated Assessor as CEPI may instruct, including data regarding CMC, formulation or the results of any of its pre-clinical or clinical trials (duly anonymised and, upon CEPI’s request, blinded) and other documents and information such as study protocols, case report forms needed to develop standardised 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 anonymised and, at CEPI’s request, blinded) for the purposes of signal detection or meta-analyses of safety data (including across product candidates).

11. Compliance

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11.2 CEPI’s Third Party Code and Cost Guidance. The Third Party Code is a statement of CEPI’s values and of the policies, practices and principles applicable to recipients of CEPI funding. CEPI shall notify Awardee of material changes to the Code without undue delay. CEPI’s Cost Guidance provides additional information regarding the treatment of costs. […]

(e) Awardee shall cooperate as may be 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).

15. Equitable Access

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15.4 Pandemic Period Production Reporting. During the Pandemic Period, Awardee shall:

(a) provide the JMAG with a regularly updated quarterly statement of its actual capacity and a forecast of its planned capacity for the following four (4) calendar quarters for the manufacturing of Project Vaccine under this Agreement and otherwise;

(b) provide the JMAG with advance notice in writing of all manufacturing runs for the Project Vaccine in accordance with agreed forecasting;

(c) discuss in good faith with the JMAG how to achieve its requirements for doses of Project Vaccine, including any potential increase in Awardee’s manufacturing capacity.

15.5 Volume Commitment. Awardee shall: […]

(f) upon receipt of written request from CEPI, provide reasonable information to CEPI about its production, supply, pricing and sales of Project Vaccine which is sufficient for CEPI to evaluate whether such activities are in accordance with Awardee’s obligations under this Agreement;

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15.11 Information about Production, Supply, Pricing and Sales. At any time during the Term, and during any period after expiry of the Term that Awardee is making sales of Project Vaccine pursuant to Section 15.3, upon written request by CEPI, Awardee shall provide reasonable information about its COGs, production, supply, pricing and sales of Project Vaccine sufficient to enable CEPI to evaluate whether such activities meet the Equitable Access Policy.

15.12 Audit of Cost of Goods. At any time during the Term, and during any period after expiry of the Term until the date that is five (5) years after the expiry of any pricing obligations pursuant to Clause 15.9, no more than once per twelve (12) month period and at CEPI’s reasonable cost, CEPI shall have the right to review or to designate an external auditor (which shall be an internationally recognised certified public accounting firm, not engaged on a contingent basis) to review Awardee’s financial records relevant to the information provided in Clause 15.9. Such audits will be conducted during normal operating hours in a manner which minimises disruption to Awardee’s business. In the 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 pricing obligations in Clause 15, then Awardee shall: (i) reimburse the reasonable costs of the audit; and (ii) take immediate steps, as advised by the auditors, to comply with the requirements of this Clause 5. The provisions of this Clause 15.12 shall also apply to any Subawardees and Trusted Collaborators.