Master Alliance Provisions Guide (MAPGuide)

CEPI – Novavax, COVID-19 Vaccine Funding Agreement

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<p class=”p2“><span style=”textdecoration: underline;”><b>3. b><b>Use of Funds; Procurement; Project Recordsb>span>p>
<p><strong>3.7 Financial Reports.strong> Awardee shall provide reports of its expenditures under the Budget with supporting documentation and using a template provided by CEPI (“<em><strong>Financial Reportsstrong>em>”) within [***] of a Projects [***], 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.p>
<p><strong>3.8 Project Records.strong> Awardee shall keep accurate records of its Project activities and expenditures under each Work Package and retain them for [***] after termination of this Agreement.p>
<p><strong>3.9 Access to Financial Records.strong> 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 CEPIs reasonable cost, shall have onsite access to inspect Awardees Projectrelated 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 Awardees business. For clarity, access to such records also shall be provided to records related to Cost of Goods as described in <span style=”textdecoration: underline;”><a href=”” target=”_blankrel=”noopener“>Clause 14a>span>.p>
<p><strong>3.10 Project Financial Audits.strong> During the term and for a period of [***] after expiration or termination of this Agreement, if requested by CEPI, and at CEPIs reasonable cost, [***] notice, Awardees 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 Awardees business.p>
<p><span style=”textdecoration: underline;”><strong>10. Independent Assessorsstrong>span>p>
<p><strong>10.1 Independent Assessors.strong> As described in a Work Package or as otherwise reasonably required by CEPI, CEPI may engage one or more independent thirdparty laboratories or collaborators (“<em><strong>Assessorsstrong>em>”), in confidence and at CEPIs expense, to evaluate Project Results, including the Project Vaccine, in order to provide CEPI with directly comparable evaluations of similar materials produced under CEPIs portfolio of awarded projects. The results of the testing, analysis, metaanalysis 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 Awardees 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 CEPIs assessors is the Task Force for Global Health and its SPEAC team of vaccine safety experts.p>
<p><strong>10.2 Awardee Cooperation.strong> Awardee shall provide reasonable assistance to CEPI and any designated Assessor, including:p>
<p style=”paddingleft: 25px;”>(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 tobeagreedupon material transfer agreement to be entered into between Awardee and the Assessor in addition to any other applicable laws and regulations.p>
<p style=”paddingleft: 25px;”>(b) cooperate in regard to data analysis, to the extent relevant under a given Work Package, by CEPIs Assessor by:p>
<p style=”paddingleft: 50px;”>(i) providing data or other information generated under this Agreement to CEPIs designated Assessor as CEPI shall request, including data regarding CMC, formulation or the results of any of its preclinical or clinical trials (duly anonymized and, upon CEPIs 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;p>
<p style=”paddingleft: 50px;”>(ii) providing CEPIs designated Assessor with other data (duly anonymised and, upon CEPIs request, blinded) as CEPI may reasonably request in order to conduct comparative assessments; andp>
<p style=”paddingleft: 50px;”>(iii) providing CEPIs designated Assessor with clinical trial data (duly deidentified and, at CEPIs request, blinded) for the purposes of signal detection or metaanalyses of safety data (including across product candidates).p>
<p><span style=”textdecoration: underline;”><strong>14. Equitable Accessstrong>span>p>
<p><strong>14.4 strong><span style=”fontweight: 400;”><strong>Pandemic Period Production and Supply.strong> During the Pandemic Period, Awardee shall:span>p>
<p style=”paddingleft: 25px;”>[&#8230;]p>
<p style=”paddingleft: 25px;”>(b) provide the <a href=”#kt“>JMAGawith a regularly updated [***] statement of its actual capacity and a forecast of its planned capacity for manufacturing of Project Vaccine;p>
<p style=”paddingleft: 25px;”><span style=”fontweight: 400;”>(c) span><span style=”fontweight: 400;”>provide the JMAG with [***] advance written notice of each manufacturing run for the Project Vaccine;<br />
<p style=”paddingleft: 25px;”>[&#8230;]p>
<p style=”paddingleft: 25px;”>(e) discuss in good faith with JMAG how to achieve its requirements for doses of Project Vaccine, including any potential increase in Awardees manufacturing capacity.p>
<p><strong>14.7 strong><strong>Costs and Sales.strongConsistent with the commitments in Clauses 14.4 to 14.6, Awardee shall:p>
<p style=”paddingleft: 40px;”>(aprovide written [***] updates to the JMAG regarding its COGs for Project Vaccines and discuss relevant product development decisions that could affect COGs; andp>
<p style=”paddingleft: 40px;”>[&#8230;]p>
<p><strong>14.8strong><strong>Information about Production, Supply, Pricing and Sales.strongUpon 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.p>
<p><strong>14.9strong><strong>Audit of Cost of Goods.strongNo more than [***] and at CEPIs 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 Awardees 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 Awardees 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 SubGrant Awardees and <a href=”#kt“>Trusted Collaboratorsa>.p>