Provision Language
Definitions
“AMC Countries” means those countries which are eligible to participate in the COVAX AMC from time to time (listed in Annex E as at the Effective Date).
“Canada Agreement” means the agreements between the Strategic Innovation Fund of Canada and Variation Biotechnologies Inc. executed Sept 16th 2020 including any extensions or amendments thereto, provided that any such amendment is consistent with CEPI’s rights hereunder.
“Pandemic Period” means the period of time beginning on 30 January 2020, when the World Health Organization (or “WHO”) declared COVID-19 to be a Public Health Emergency of International Concern (or “PHEIC”), and ending on the earlier of (1) the date on which WHO declares that the COVID-19 PHEIC is over or (2) the date determined by CEPI, in its reasonable discretion in consultation with the Awardee and based on epidemiological data published by WHO, including.
“Pre-existing Agreements” means the agreements entered into by the Awardee prior to the Effective Date details of which are set out in Exhibit H.
“Volume Commitment Percentage” means the relevant percentage of the Awardee’s capacity to produce Project Vaccine together with Trusted Manufacturer, where the relevant percentage shall be calculated as follows: **% for any Project Vaccine for which CEPI provides preclinical funding, **% for any Project Vaccine for which CEPI funds through Phase 1 clinical study, **% for any Project Vaccine for which CEPI funds through Phase 2 clinical study, **% for any Project Vaccine for which CEPI funds through Phase 3 clinical study, and **% for any Project Vaccine for which CEPI funds through to (i) approval and registration as set out in the iPDP; (ii) WHO pre–qualification or emergency use listing; and (ii) reasonably sufficient commercial manufacturing capabilities as required to meet Awardee’s obligations hereunder. In the event that CEPI co–funds with a third party organization, VBI, CEPI and the third party organization will negotiate an appropriate Volume Commitment Percentage commensurate with the respective interests of the party, funding contributions and stage of investment (provided always that such Volume Commitment Percentage shall be no lower than the Volume Commitment Percentage applicable to the funding stage immediately prior to the latest stage to which CEPI has provided funding).
13. Project Continuity
13.1 Awardee Contingency Plan. Awardee shall prepare and maintain a contingency plan to minimise any potential disruption to the Project, and provide a copy of the plan to CEPI in confidence as it relates to the Project as required under the iPDP.
13.2 Project Continuity Plan. Because of the exigent nature of the Outbreak, the iPDP shall include a Project Continuity Plan that, at a minimum, shall address the following items: […]
(c) identification of a proposed third party, within a timeframe to be established in the iPDP, such as a Subawardee, under contract to Awardee, which is capable of performing the activities in agreed Work Packages, any additional Work Packages or a Project expansion (“Trusted Collaborator”), in the event that Awardee is unable to continue its activities under this Agreement or declines CEPI’s request to undertake additional Work Packages or a Project expansion. Awardee’s Subawardee agreement(s) with Trusted Collaborator shall expressly permit Awardee to assign the agreement to CEPI if so requested by CEPI pursuant to Clause 13.6; and
(d) requirement for the Awardee to use its reasonable endeavours to sign Subawardee agreement(s) with one or more operational manufacturing facilities at one or more geographically dispersed manufacturing sites located in LMICs, within a timeframe to be established in the iPDP, or within such other time period as may be set out in the iPDP from time to time, which Awardee will contract with as described in the iPDP to produce Project Vaccine for use in the Field (“Trusted Manufacturer”). Awardee’s Subawardee agreement(s) with Trusted Manufacturer(s) shall (i) comply with the relevant requirements of this Agreement; (ii) enable Awardee to use theTrusted Manufacturers to produce the Project Vaccine for supply in accordance with Clause 15.5 (Volume Commitment); (iii) shall include a right for CEPI to reserve manufacturing capacity with the Trusted Manufacturer; and (iv) shall expressly permit Awardee to assign the agreement to CEPI if so requested by CEPI pursuant to Clause 13.6. The terms of such Subawardee agreement shall be subject to CEPI’s prior written consent. Awardee shall notify CEPI of the identity of the Trusted Manufacturer(s) and provide a copy of the relevant final Subawardee agreement(s) to CEPI without undue delay after the entry into the Subawardee agreement(s).
13.3 Alternative Designations by CEPI. If Awardee does not designate a Trusted Collaborator and/or Trusted Manufacturer, or a designated Trusted Collaborator and/or Trusted Manufacturer notifies Awardee that they are no longer available, then CEPI may propose a Trusted Collaborator or Trusted Manufacturer to Awardee. Neither Party may unreasonably decline to accept the designation of a proposed Trusted Collaborator under Clause 13.2 or this Clause 13.3. Once designated and under contract to pursue Project activities, a Trusted Collaborator and Trusted Manufacturer shall be a Subawardee for the purposes of this Agreement.
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13.5 Public Health Licence Triggers. Consistent with Clause 13.4, CEPI shall have the right to exercise the Public Health Licence in the event that any one or more of the following events occurs: […]
(c) Awardee is in material breach of this Agreement or the Equitable Access Plan and has not cured such breach within thirty (30) Business Days of notification of such breach by CEPI, unless otherwise mutually agreed in writing; or
15. Equitable Access
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15.2 Project Vaccine Registration. Awardee shall cooperate with CEPI or CEPI’s designee to take such actions as are reasonably agreed and funded as agreed between the Parties in the Budget to register Project Vaccines in countries identified as priorities which are set out in the iPDP or as may be mutually agreed by the Parties in an advanced purchase agreement or otherwise. If Awardee is not the licence holder for the purposes of registration in a given country, then Awardee shall be responsible for ensuring that any applicable Subawardee facilitates such registrations as instructed by and funded as agreed between the Parties in the Budget. As soon as practicable, Awardee shall liaise with WHO to apply for WHO pre–qualification or a similar registration system to the extent available and shall implement such systems as soon as they have been approved by WHO.
15.3 Global Allocation and Purchase. It is the Parties’ expectation that Gavi, pursuant to COVAX (or a similar purchasing entity as otherwise reasonably directed by CEPI), shall provide funding to purchase the Project Vaccine and be responsible for its allocation. Awardee shall respond promptly to any Gavi or UNICEF or CEPI identified Request for Proposal for a COVID–19 vaccine. Awardee shall negotiate in good faith with Gavi (or as otherwise reasonably directed by CEPI) to sign a purchase commitment or purchase order to supply Project Vaccine as maybe required by Gavi, CEPI or any designee of Gavi or CEPI whether during or after a Pandemic Period, in accordance with and subject to the provisions of Clauses 15.5 and 15.7. As part of the good faith negotiation, the Parties shall negotiate and settle the costs, expenses and other factors to be used in the calculation of COGs, such negotiation and settlement to, at all times, be guided by and reflect the principle that Awardee shall not suffer financial losses when supplying Project Vaccine to any market and take into account the amount of funding provided by CEPI and any other grants or public funding received by Awardee or Subawardee from third parties.
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15.5 Volume Commitment. Awardee shall:
(a) during the Pandemic Period, produce Project Vaccine in quantities which shall be at least equal to the quantities described in the Work Package(s);
(b) during the Pandemic Period, subject only to the Awardee’s supply obligations under the Pre–existing Agreements (including Section 6.3.1 of the Canada Agreement) which have been communicated to CEPI as required under the iPDP, offer the Volume Commitment Percentage of the Project Vaccine produced pursuant to Clause 15.5(a) for purchase by Gavi, CEPI or their respective designees pursuant to Clause 15.3 during the Pandemic Period. For clarity, Awardee may not allocate or agree to supply such Project Vaccine doses to other third parties, other than as required pursuant to the Pre–existing Agreements, during the Pandemic Period without the express written permission of Gavi, CEPI or their respective designee;
(c) After the Pandemic Period, for a period lasting until the later of (i) five years from the end of the Pandemic Period; or (ii) ten years from the Effective Date; subject to the same limitations as Section 15.5(b), if CEPI determines in its reasonable discretion in consultation with the Awardee that a regional but not a global Outbreak exists, then Awardee shall offer a percent of the total quantity of the Project Vaccine produced for purchase by Gavi, CEPI or their respective designees pursuant to Clause 15.3 equal to the Volume Commitment Percentage multiplied by the percentage of the world population that resides in the region in which the Outbreak exists; save that where a regional Outbreak exists in a relatively small population (as reasonably determined by CEPI), the Parties shall discuss in good faith an increase in the Volume Commitment Percentage in order to adequately address such an Outbreak. For example, if the Volume Commitment Percentage was ** and there was an Outbreak in Africa, then, based on 2020 census data, approximately ** of Project Vaccine would be offered for purchase by Gavi;
(d) supply Project Vaccine doses to COVAX in a timely manner that enables COVAX represented economies to receive Project Vaccine in a similar timeframe to other third party customers;
(e) consistent with the commitments in Clauses 15.4 to 15.6, subject only to the Awardee’s supply obligations under the Pre–existing Agreements (including Section 6.3.1 of the Canada Agreement) which have been communicated to CEPI as required under the iPDP, sell the Project Vaccine doses to Gavi, CEPI or their respective designees during and after the Pandemic Period pursuant to Clause 15.3; and
(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;
(g) subject only to the Awardee’s supply obligations under the Pre–existing Agreements (including Section 6.3.1 of the Canada Agreement) which have been communicated to CEPI as required under the iPDP, use its Commercially Reasonable Efforts to provide an amount of doses to be reasonably determined by CEPI based on the Awardee’s worldwide supply capacity and the level and timing of CEPI’s funding contribution to the global initiative “Access to COVID–19 Tools (act) Accelerator” so as to ensure availability for all, subject to the inclusion of satisfactory liability protection (which may include participation in the Gavi no fault compensation programme) and regulatory conditions. This Agreement does not cover specific details with regard to the provision of doses to the COVID–19 Tools (act) Accelerator to be concluded and agreed separately with the relevant parties involved.
15.6 Commercially Reasonable Efforts. With regard to its obligations under this Agreement, Awardee shall use its Commercially Reasonable Efforts to address the urgent medical need created by the COVID–19 pandemic by fulfilling such obligations, including achieving the objectives and timelines of each Work Package (including each Stage Gate in a Work Package) within the agreed timeframe, it being agreed that Awardee does not represent or warrant any particular outcome for any Work Package or any activity described in a Work Package or this Agreement.
15.7 Post–Pandemic Period Production and Supply. After the Pandemic Period, for a period lasting until the later of (i) five years from the end of the Pandemic Period; or (ii) ten years from the Effective Date, Awardee shall continue to produce and supply the Project Vaccine for purchase by Gavi, CEPI or their respective designees pursuant to Clause 15.3, as is required by Gavi, CEPI or their respective designees to meet the needs of AMC Countries for so long as there is demand for such supply, which quantity shall be set out in an advanced purchase agreement between the Awardee and Gavi, CEPI or their respective designees. Awardee shall negotiate and agree on the terms of any such advanced purchase agreement with Gavi, CEPI or their respective designees expeditiously and in good faith but Awardee shall not, for greater certainty, be subject to any commitments regarding volume save as otherwise set forth in Clause 15.5(c). Awardee undertakes to continue to sell Project Vaccine after the Pandemic Period for a period lasting until the later of (i) five years from the end of the Pandemic Period; or (ii) ten years from the Effective Date, to AMC Countries and to public sector entities that procure the Project Vaccine for use in AMC Countries (if there is a demand for such supply), at a reasonable price to achieve Equitable Access for populations in need of a Project Vaccine as well as an appropriate return on investment for vaccine manufacturers, and ensuring that on–going supply is commercially sustainable.
17. Representations and Warranties
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17.2 Awardee Representations. During the Term of this Agreement, Awardee shall: […]
(e) notify CEPI promptly if it becomes aware that any actions are likely or have already been taken by the government of any country in which Awardee shall conduct Project activities that may adversely affect Awardee’s commitments in this Agreement, including Equitable Access. For clarity, such government actions may relate, for example, to the exercise of eminent domain or sovereign rights over Project Vaccine doses.