Provision Language
Definitions
“Eligible Countries” means all GAVI Eligible Countries and GAVI Transitioned Countries plus other Low and Low–Middle Income Countries as identified by the World Bank and any other counties eligible for financial support by the GAVI COVAX AMC. As of the date of the last signature below, Eligible Countries consist of those countries listed in Exhibit A. Based on the definition of Eligible Countries as set forth in this Section 2, countries may be removed from or added to Exhibit A. “GAVI Eligible Countries” means all countries which are deemed GAVI–eligible countries by GAVI, including those in preparatory or accelerated transition, as such GAVI–eligible countries may be added or deleted by the GAVI from time to time. “GAVI Transitioned Countries” means all countries which were at one time deemed GAVI–eligible countries by GAVI.
“Total Annual Doses” means the total number of doses of Covid Vaccine produced by Icosavax and/or its manufacturing and/or commercial partner(s) in a given 12–month period commencing on the date that Icosavax and/or its manufacturing and/or commercial partner(s) commenced supplying Covid Vaccine to a Public Sector Purchaser.
3. Global Access Commitments
In furtherance of the Charitable Purpose, Icosavax agrees to the following “Global Access Commitments”:
(b) Continued Development. In the event of successful completion of the Phase 1 study of the Covid Vaccine as described in the Project, and the Foundation has made all payments to Icosavax in accordance with the terms of the Grant Agreement, Icosavax will take reasonable steps to obtain additional funding for completing the activities necessary to further develop the Covid Vaccine beyond the Phase 1 study. Within [***] of the [***], Icosavax will have received or will have a [***] to further develop, manufacture, and/or distribute the Covid Vaccine. If Icosavax [***] and continues the development and commercialization of the Covid Vaccine, the following terms apply: […]
(i) Regulatory Commitment. Icosavax will ensure that the Essential Background Technology and Funded Developments it owns or controls now or in the future are managed in a manner to support the relevant regulatory approvals and WHO Prequalification of the Covid Vaccine.
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(iii) Annual Volume Commitment. Upon obtaining applicable regulatory approvals and in accordance with applicable laws, Icosavax will use reasonable efforts to ensure that it or its manufacturing and/or commercial partner(s) will manufacture, package, label, store and ship the quantities of Covid Vaccine necessary to fulfill all purchase orders awarded and bound to Icosavax and/or its manufacturing and/or commercial partner(s) from Public Sector Purchasers to purchase Covid Vaccine for use in the Eligible Countries for the Charitable Purpose in the following quantity: a. an annual capacity available to Eligible Countries that is at least [***] of Icosavax’s Total Annual Doses (the “Annual Volume Commitment”).
(iv) Annual Volume Commitment Term. Icosavax and/or its manufacturing and/or commercial partner(s) will provide the Annual Volume Commitment for a [***] period commencing on the date of first supplying the Covid Vaccine to a Public Sector Purchaser and ending on the [***] anniversary thereof (the “Annual Volume Commitment Term”).
(v) Manufacturing and Supply. Before finalizing a partnership with its manufacturing and/or commercial partner(s), Icosavax will ensure that its agreement(s) with these manufacturing and/or commercial partner(s) have appropriate provisions to support the furtherance of Global Access for the Charitable Purpose, including assurances that the Covid Vaccine will be provided at the Price Commitment and Annual Volume Commitment outlined above consistent with this Agreement.
(vi) Termination of Price and Volume Commitments. If, for [***], Icosavax and/or its manufacturing and/or commercial partner(s) fulfill all of their obligations pursuant to Section 3(b)(i)-(v) and through no fault of Icosavax and/or its manufacturing and/or commercial partner(s) there are insufficient purchase orders to enable Icosavax and/or its manufacturing and/or commercial partner(s) to sell at least [***] of Icosavax’s Total Annual Doses of Covid Vaccine, for each Annual Period, then the applicable Price Commitment and Annual Volume Commitment set forth in Section 3(b)(ii) and Section 3(b)(iii) shall terminate beginning with the next Annual Period, and the Foundation and Icosavax will meet and discuss in good faith the applicable Price Commitment and Annual Volume Commitment for the remaining Annual Periods.
(vii) Insufficient Supply to Meet Global Demand. If global demand for the Covid Vaccine by Public Sector Purchasers exceeds Icosavax’s and/or its manufacturing and/or commercial partner(s)’ Annual Volume Commitment, the Parties shall discuss in good faith the solution to meet such global demand, including without limitation additional funding to increase Icosavax’s and/or its manufacturing and/or commercial partner(s)’ annual capacity. If the Parties fail to reach an agreement, Icosavax will in good faith cooperate with the Foundation in making available the Funded Developments and Essential Background Technology relating to the Project available to the Foundation (or any other Person designated by the Foundation) and provide adequate tech transfer (under non–exclusive licenses with terms to be negotiated in good faith), to continue to develop the Covid Vaccine and to enable the use, design, research, development, production, manufacture, sale, distribution, import, or export of the Covid Vaccine solely for use in the Eligible Countries for the Charitable Purpose.
(viii) ACT–A Coordination. At the Foundation’s request, the Parties agree to negotiate in good faith to modify and amend this Agreement, including the Global Access Commitments, to align with any applicable allocation, procurement and/or coordination mechanism established under the Access to Covid–19 Tools Accelerator, a WHO–led Global Collaboration to accelerate the development, production and equitable access to new Covid–19 diagnostics, therapeutics and vaccines.