Provision Language
11. Compliance
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11.2. Compliance with CEPI’s Policies and Procedures. Awardee shall comply with those CEPI policies and procedures communicated to Awardee as they apply to the activities performed under the Project and the use of CEPI funds. As of the Effective Date of this Agreement, these policies and procedures consist of the Third Party Code and Cost Guidance . For clarity, the Third Party Code is a periodically updated, consolidated statement of CEPI’s mission and vision, which further describes and incorporates various CEPI policies, procedures and requirements applicable to recipients of CEPI funds. The Third Party Code also describes requirements for procurements and sub–grants. For avoidance of doubt, Awardee shall be considered to have satisfied the Procurement Requirements of Article 14 of the Third Party Code in regard to those procurements/activities in the Budget or a Work Package for which Awardee has specifically identified a Subawardee. The Cost Guidance describes CEPI’s principles regarding eligible direct and indirect costs, non–eligible costs, and valuing in–kind contributions. CEPI shall advise Awardee from time–to–time of material changes to such policies and procedures.
14. Equitable Access
14.1. Commitment to Equitable Access. CEPI is committed to achieving equitable access to the results of all CEPI–supported programmes pursuant to the “Equitable Access Policy” referenced in CEPI’s Third Party Code. Equitable Access means that a Project Vaccine is available first to populations at risk when and where they are needed at affordable prices. For clarity, it is CEPI’s intention that the price of a Project Vaccine shall be commercially sustainable to the manufacturer.
14.2. Project Vaccine Registration. Awardee shall cooperate with CEPI, and at CEPI’s cost, take such actions as are mutually agreed to register Project Vaccines in countries identified as priorities. If Awardee is not the license holder for purposes of registration in a given country, then Awardee shall be responsible for ensuring that its Subawardee facilitate such registrations as requested by CEPI. Awardee shall utilize WHO pre–qualification or similar registrations systems to the extent available.
14.3. Global Allocation. It is the Parties’ expectation that a global allocation and purchasing entity (the “Global Allocation Body”) shall be constituted within six (6) months after the Effective Date of this Agreement to purchase, allocate, and direct the distribution of COVID–19 vaccines including Project Vaccine. Awardee, will negotiate, in good faith a separate agreement or purchase order to supply Project Vaccine as may be required by the Global Allocation Body in such agreement or purchase order to the Global Allocation Body during the Pandemic Period and after the Pandemic Period for LMICs. For the purposes of this paragraph “Pandemic Period” means the period of time between the date that WHO declared COVID–19 to be a PHEIC [Public Health Emergency of International Concern] (that is, 30 January 2020) and the date that WHO declares the PHEIC to have ended including any period of a COVID–19 pandemic re–emergence as declared by the WHO.
14.4. Pandemic Period Production and Supply. During the Pandemic Period, Awardee shall:
(a) produce Project Vaccine as described in the Work Package(s), if not greater;
(b) provide the JMAG with a regularly updated [***] statement of its actual capacity and a forecast of its planned capacity for manufacturing of Project Vaccine;
(c) provide the JMAG with [***] advance written notice of each manufacturing run for the Project Vaccine;
(d) supply up to [***] of the quantity of the Project Vaccine produced for purchase by the Global Allocation Body pursuant to Clause 14.3 during the Pandemic Period. For clarity, Awardee may not allocate or obligate Project Vaccine doses to other third parties during the Pandemic Period that conflicts with its obligations under this Clause 14; and
(e) discuss in good faith with JMAG how to achieve its requirements for doses of Project Vaccine, including any potential increase in Awardee’s manufacturing capacity.
14.5. Post–Pandemic Period Production and Supply. After the Pandemic Period, Awardee shall continue to produce and supply Project Vaccine for purchase as required by the Global Allocation Body pursuant to Clause 14.3.
14.6. Pricing Objectives. The Parties acknowledge that the price of the Project Vaccine is critical to achieving Equitable Access during the Pandemic Period. Accordingly, Awardee agrees that its pricing shall be reasonable to achieve Equitable Access for populations in need of a Project Vaccine as well as an appropriate return on investment for vaccine manufacturers that make on–going supply commercially sustainable. The Parties acknowledge that the availability of pandemic insurance as described in Clause 17.7 shall be a relevant cost factor in Equitable Access. For clarity, the purchase of Project Vaccine by the Global Allocation Body or by any other purchasing agent(s) designated by CEPI shall be considered to have satisfied the pricing requirements for Equitable Access.
14.7. Costs and Sales. Consistent with the commitments in Clauses 14.4 to 14.6, Awardee shall:
(a) provide written [***] updates to the JMAG regarding its COGs for Project Vaccines and discuss relevant product development decisions that could affect COGs; and
(b) sell the Project Vaccine doses to the Global Allocation Body during and after the Pandemic Period pursuant to Clause 14.3.
14.8. Information about Production, Supply, Pricing and Sales. Upon 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.
14.9. Audit of Cost of Goods. No more than [***] and at CEPI’s 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 Awardee’s 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 Awardee’s 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 Sub–Grant Awardees and Trusted Collaborators.
14.10. Manufacturing in Multiple Countries. Awardee shall use [***] to establish operational manufacturing facilities in one or more geographically dispersed manufacturing sites as described in the Work Packages.
14.11. Equitable Access Plan. The foregoing commitments regarding Equitable Access shall constitute the “Equitable Access Plan.” This Equitable Access Plan shall be reviewed by JMAG no less than annually and shall take into account changes in COGs over time, production yield and volume and production economics. The Equitable Access Plan shall be regularly updated during the term of this Agreement.
14.12. Alternative to the Global Allocation Body. In the event that a Global Allocation Body is not constituted as expected by the Parties in Clause 14.3, then CEPI or its designated purchasing agent(s) shall have the rights attributed in this Clause 14 to the Global Allocation Body.