Provision Language
“Annual Period” means each 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. The first Annual Period is referred to as Annual Period 1 and so forth.
“Cost of Goods Sold” or “COGS” means the total cost of production, manufacturing, packaging, temperature monitoring devices as required by WHO guidelines on the international packaging and shipping of vaccines (WHO/IVB/05.23) or any later revision, vaccine vial monitors, and delivery in accordance with INCOTERM FCA to the designated airport as determined in accordance with the Foundation’s COGS Principles and Assessment Methodology Handbook available at: https://docs.gatesfoundation.org/Documents/Production_Economics_Vaccines_2016.pdf, which may be modified from time to time.
“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”:
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(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: […]
(ii) Price Commitment. Icosavax will ensure that it or its manufacturing and/or commercial partner(s) sell the Covid Vaccine to Public Sector Purchasers for use in Eligible Countries for the Charitable Purpose at no more than [***] above the combined COGS for Covid Vaccine [***] (the “Price Commitment”).
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(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.