Global Commercialization Budget(s). At such times as the JCC will deem appropriate, but in no event later than [***] prior to the anticipated date of first filing for Regulatory Approval for a Collaboration Product, and concurrently with the preparation of the initial Global Commercialization Plan, on a Collaboration Product-by-Collaboration Product basis, Merck will prepare an initial budget for the Global Commercialization Plan for such Collaboration Product, that outlines the financial resources and expenses to be incurred by or on behalf of the Parties (or their Affiliates) in execution of the Global Commercialization Plan, with input from Moderna on costs associated with activities assigned to Moderna in the associated Global Commercialization Plan (each a “Global Commercialization Budget”). The JCC will review and comment on and the JSC will approve such Global Commercialization Budget; provided that the Global Commercialization Budget may not be increased by more than [***] of the anticipated Allowable Commercialization Costs in such Global Commercialization Budget within a Calendar Year without submitting an amended Global Commercialization Budget for review and comment by the JCC and approval by the JSC; provided that, Merck shall have the right to incur Commercialization costs in excess of [***] of the anticipated Allowable Commercialization Costs in such Global Commercialization Budget within a Calendar Year to the extent that such Commercialization costs that are not previously approved by the JSC shall be solely borne by Merck for the purposes of calculating each Party’s share of the Cash Profits or Losses for such Calendar Year. Thereafter, Merck, with input from Moderna, will update the Global Commercialization Budget at least [***] per Calendar Year (and in any event at any time the Global Commercialization Plan is updated or amended with respect to any Commercialization Activities), and the JCC will review and comment on and the JSC shall approve any such update or any other amendment to the Global Commercialization Budget. The JCC will set the required form and contents of the Global Commercialization Budget, but at a minimum the contents shall include [***].
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Sources: Mrna Cancer Vaccine Collaboration and License Agreement, Mrna Cancer Vaccine Collaboration and License Agreement