Provision Language
<p><em><strong>Definitionsstrong>em>p>
<p>“<strong>Increased Outbreak Preparation Needstrong>” means when, having considered all reasonably accessible and relevant information including epidemiological data, travel and migration patterns and the likely availability of other products or product candidates, CEPI determines, in its sole discretion in consultation with experts (for example a sub–group or subcommittee of CEPI’s Scientific Advisory Committee that CEPI determines has appropriate expertise), that there is a heightened need for the Product to address potential <a href=”#kt“>Outbreaksa>.p>
<p><span style=”text–decoration: underline;”><strong>3. strong><b>Sub–Awardee Participation in the Project b>span>p>
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<p class=”p2“><strong>3.4strong> The Awardee will: […]p>
<p style=”padding–left: 40px;”>b. in addition to, and without in any way diminishing or otherwise altering, Awardee’s obligations under this Agreement (including Clause 14.3) and under the IPDP with respect to use of Sub–Awardees in <a href=”#kt“>LMICsa>, cooperate with CEPI in good faith and to the extent reasonably possible to preferentially use Sub–Awardees operating in LMICs where Outbreaks are likely to occur in order to build infrastructure and develop experienced personnel in the relevant territory; andp>
<p><span style=”text–decoration: underline;”><strong>14. Equitable Accessstrong>span>p>
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<p><strong>14.3 LMIC Manufacturer.strong> To facilitate achievement of the conditions set out in <span style=”text–decoration: underline;”><a href=”https://ghiaa.org/provision_document/cepi–valneva–chikungunya–vaccine–funding–agreement–13/” target=”_blank” rel=”noopener“>Clauses 14.1 and 14.2a>span>, Awardee has agreed to transfer its technology to an LMIC manufacturer as outlined in the <a href=”#kt“>IPDPa>. Without limiting Awardee’s obligations under the IPDP, Awardee will, within [***] of the signature date of this Agreement, or within such other time period as may be set out in the IPDP if the IPDP is amended in accordance with Clause 2.4, sign a Sub–Awardee agreement with an LMIC manufacturer, which Sub–Awardee agreement shall meet the requirements of Clause 3.3 and shall obligate such LMIC manufacturer to manufacture the Product for regular supply in all Non–Traveler’s Market Countries that have a demand for Product and to supply the Product to Non–Traveler’s Market Countries under the conditions of Clause 14.2. Prior to signing such Sub–Awardee agreement with an LMIC manufacturer and prior to completion of technology transfer to enable such LMIC manufacturer to manufacture and supply the Product to Non–Traveler’s Market Countries, Awardee shall fulfill manufacturing and supply obligations for Non–Traveler’s Market Countries as set out in the IPDP.p>
<p><strong>14.4 Regulatory Approvals in LMICs.strong> Awardee will, or will obligate its Sub–Awardee(s) to, use reasonable endeavours to obtain regulatory approvals and licensure for the Product in Non–Traveler’s Market Countries where there is a demand for the Product. The Parties, through the <a href=”#kt“>JMAGa>, may discuss and agree on a list of such Non–Traveler’s Market Countries in which to seek such approvals and licensure and on a schedule for seeking such approvals and licensure, and Awardee will, or will obligate its Sub–Awardee(s) to, use reasonable endeavours to meet such schedule in such countries.p>
<p><span style=”text–decoration: underline;”><strong>16. Preparation for Outbreaksstrong>span>p>
<p><strong>16.1 Outbreak.strong> CEPI will notify Awardee in writing in the event of an Outbreak or if there is an Increased Outbreak Preparation Need, in each case identifying the Affected Territory (“<em><strong>Outbreak Noticestrong>em>”). Once an Outbreak Notice has been provided by CEPI, CEPI shall have the right to direct how the Safety Stock referred to in <span style=”text–decoration: underline;”><a href=”https://ghiaa.org/provision_document/cepi–valneva–chikungunya–vaccine–funding–agreement–3/” target=”_blank” rel=”noopener“>Clause 15.2 aa>span>. or any Product manufactured pursuant to Clause 16.3 may be used and to whom it may be provided in the Affected Territory. In consultation with relevant public health authorities in the Affected Territory, CEPI may request that Awardee discuss in good faith whether and how the Project Results could be utilized in response to the Outbreak Notice. Awardee is committed to use commercially reasonable best efforts to address Outbreaks and Increased Outbreak Preparation Need wherever they occur in the world. Following receipt of an Outbreak Notice, Awardee will use its commercially reasonable best efforts to increase the supply of Product available for use by CEPI or its nominees to an amount which equals at least [***] of the production forecast for the Products prepared by Awardee immediately prior to service of the Outbreak Notice and Awardee will use its commercially reasonable best efforts to ensure that such increased capacity is available for delivery to CEPI within [***] of the date of service of the Outbreak Notice. For clarity, Awardee will use commercially reasonable best efforts to keep such deadline of [***] (including discussing with Awardee’s contract manufacturers how they can meet the proposed deadlines), however, Awardee’s ability to meet deadlines will be subject to the lead times of Awardee’s contract manufacturers and the time required for the release testing of the Product. In the event that CEPI’s request for Product to meet the increased demand during an Outbreak or Increased Outbreak Preparation Need is in excess of the quantities that Awardee is able to supply to CEPI based on Awardee’s commercially reasonable best efforts, Awardee shall not be obliged to supply Product to CEPI under this Clause 16.1 to the extent that the supply of such quantities of Product to CEPI would result in Awardee being in breach of any binding contracts in existence on the date of service of the Outbreak Notice (which for the avoidance of doubt may include the supply of Products to customers for Awardee’s Traveler’s Market or in connection with any clinical trials). In such event, provided that Awardee has supplied Product in accordance with this Clause 16.1, Awardee shall not be considered to be in default, and Clauses <span style=”text–decoration: underline;”><a href=”https://ghiaa.org/provision_document/cepi–valneva–chikungunya–vaccine–funding–agreement–3/” target=”_blank” rel=”noopener“>16a>span> and <span style=”text–decoration: underline;”><a href=”https://ghiaa.org/provision_document/cepi–valneva–chikungunya–vaccine–funding–agreement–10/” target=”_blank” rel=”noopener“>17a>span> shall not apply.p>
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<p><strong>16.4 Trusted Collaborator.strong> Promptly after receipt of a written request from CEPI (or at any earlier time), Awardee will propose a third party, for example, a Sub–Awardee, as a preferred alternative to itself (“<em><strong>Trusted Collaboratorstrong>em>”), that is capable of performing the work and would be prepared to undertake activities pursuant to Clause 16.2 or 16.3 in the event that Awardee declines CEPI’s request to do so, or if Awardee and CEPI do not reach agreement on a new Work Package. CEPI may also propose a Trusted Collaborator to Awardee. Neither Party may unreasonably decline to accept the designation of a proposed Trusted Collaborator.p>
<p><strong>16.5 Technology Transfer.strong> As described in the <a href=”#kt“>IPDPa>, Awardee will be transferring technology to two Sub–Awardees (IDT and an LMIC manufacturer) and the costs of such technology transfers are included in the Project Budget. Awardee will promptly and diligently provide all necessary guidance, information, materials and assistance reasonably required to transfer Awardee’s technology to each such Sub–Awardee as outlined in the IPDP. Pursuant to an Outbreak Notice, CEPI may request to accelerate the timelines for transfer of Awardee’s technology to one or both of such Sub–Awardees and/or CEPI may request an expansion of the transfer to another Trusted Collaborator (other than such Sub–Awardees) if that would achieve the transfer more quickly. If CEPI requests transfer of Awardee’s technology to another Trusted Collaborator, Awardee will promptly and diligently provide all necessary guidance, information, materials and assistance reasonably required by such Trusted Collaborator to accomplish the activities that may be requested by CEPI under Clause 16.2 or 16.3 (“<em><strong>Technology Transferstrong>em>”) at CEPI’s cost. Awardee shall carry out the Technology Transfer to such other Trusted Collaborator pursuant to the terms and conditions of a to–be–agreed–upon confidentiality agreement in accordance with this Agreement to be entered into between Awardee and the Trusted Collaborator governing the Trusted Collaborator’s use and non–disclosure of information and materials provided in connection with the Technology Transfer, provided that Awardee and the Trusted Collaborator shall not delay the execution of such agreement.p>
