Master Alliance Provisions Guide (MAPGuide)

Gavi Alliance – Novavax, COVID-19 Vaccine Advance Purchase Agreement

  • Protecting & sharing information | Information sharing

<p class=”p1“>“<b>CFNb>” means, for the purposes of this Agreement, the following manufacturing facilities funded in whole or part by CEPI under the CEPI Funding Agreement in which CFN Drug Substance is made: [***].p>
<p class=”p1“>“<b>CFN Drug Substanceb>” means any drug substance manufactured using the CFN.p>
<p class=”p1“>“<b>CFN Vaccineb>” means any Vaccine that contains CFN Drug Substance.p>
<p><span style=”textdecoration: underline;”><b>4. Novavax Supplyb>span>p>
<p><b>4.8 b><span style=”fontweight: 400;”>Within [***] of the first day of each [***], Novavax shall provide Gavi with a [***] report detailing its [***] CFN Vaccine production and the total amount of CFN Vaccine it has delivered or otherwise made available to COVAX Buyers and Novavax Buyers in the previous [***].span>p>
<p><span style=”textdecoration: underline;”><b>9. Provision of Informationb>span>p>
<p><b>9.1 b><span style=”fontweight: 400;”>Novavax shall provide Gavi on an ongoing basis as reasonably requested by Gavi with information in relation to [***].span>p>
<p><b>9.2 b><span style=”fontweight: 400;”>Novavax shall notify Gavi promptly when [***].span>p>
<p><b>9.3 b><span style=”fontweight: 400;”>Novavax shall promptly provide to Gavi all information reasonably required for the effective operation of the WHO nofault compensation scheme. Novavax acknowledges that Gavi may share such information with the WHO for the purposes of the operation of the WHO nofault compensation scheme.span>p>
<p><b>9.4 b><span style=”fontweight: 400;”>Novavax shall provide to the COVAX Procurement Coordinator all of the information set out in Schedule 5 in accordance with the terms of that Schedule.span>p>
<p><b>9.5 b><span style=”fontweight: 400;”>Novavax shall inform Gavi upon becoming aware of any credible suspicions of any Misappropriation, Fraudulent Practice, Corrupt Practice, Coercive Practice, Collusive Practice or Obstructive Practice (each, aspan><em><b>Prohibited Practiceb>em><span style=”fontweight: 400;”>”). Further, if Gavi has reason to suspect that any payments made under this Agreement or any agreements contemplated as part of this Agreement (thespan><em><b>Fundsb>em><span style=”fontweight: 400;”>”) have been used for purposes other than the development, manufacture and making available of the Vaccine, whether due to (i) noncompliance with the terms and conditions of the relevant agreement or (ii)Novavaxs engagement in a Prohibited Practice (each aspan><em><b>Misuse of Fundsb>em><span style=”fontweight: 400;”>”), Gavi may, where permitted by law, inform Novavax. In the event of a Misuse of Funds or Novavaxs engagement in a Prohibited Practice, the Parties will consult in good faith with a view to agreeing upon a satisfactory resolution of the matter. If, following such consultation, no resolution is agreed by the Parties, Gavi may undertake an investigation (on its own behalf, or in conjunction with a third party), appoint an independent third party to investigate, or refer the matter to the appropriate authorities. If, following the completion of any investigation, Gavi determines that Novavax has engaged in the Misuse of Funds or a Prohibited Practice, Gavi may suspend all or part of its Funds. If Gavi notifies Novavax of its concern that Novavax has engaged in the Misuse of Funds or a Prohibited Practice, Novavax shall cooperate in good faith with Gavi and its representatives in determining whether such a violation has occurred and shall respond promptly and in reasonable detail to any such notice from Gavi and shall furnish documentary support for such response upon Gavis requestspan>p>
<p><span style=”textdecoration: underline;”><b>11. Representations, Warranties and Undertakingsb>span>p>
<p><b>11.2 Novavax Undertakings. b><span style=”fontweight: 400;”>During the Term of this Agreement, Novavax undertakes to:span>p>
<p style=”paddingleft: 25px;”>11.2.1 <span style=”fontweight: 400;”>notify Gavi [***] if it becomes aware that any actions are likely or have already been taken by the government of any country in which Novavax shall perform activities to procure COVAX Doses that may adversely affect Novavaxs commitments under this Agreement. For clarity, such government actions may relate, for example, to the exercise of eminent domain or sovereign rights over Vaccine doses contemplated to be procured as COVAX Doses under this Agreement;<br />
[…]<br />
11.2.3 inform Gavi of any [***];<br />
[…]<br />
11.2.5 inform Gavi of any [***]; and<br />
11.2.6 keep Gavi informed of the supply of CFN Vaccine pursuant to its supply agreements with third parties pursuant to Clause 4.8.span>p>