Global Commercialization Budget definition

Global Commercialization Budget has the meaning set forth in Section 8.4(b).
Global Commercialization Budget means the budget(s) for a particular Contract Year approved by the JCC for the applicable Global Commercialization Plan.
Global Commercialization Budget means the budget(s) for a particular Contract Year developed by the Lead Party, reviewed by the JCC and JSC, and approved by the JSC for the applicable Global Commercialization Plan.

Examples of Global Commercialization Budget in a sentence

  • The JCC will set the required form and contents of the Global Commercialization Budget, but at a minimum the contents shall include [***].

  • The Lead Commercialization Party with respect to a jurisdiction will have sole responsibility for the conduct of Commercialization activities with respect to each Shared Product in such jurisdiction in its sole discretion, subject to compliance with the approved Global Commercialization Plan, Global Commercialization Budget and Regional Commercialization Plan(s) for such Shared Product, and the provisions of this ARTICLE 5.

  • 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.

  • Each such Regional Commercialization Plan must be consistent at all times with the then-current Global Commercialization Plan (including the Global Commercialization Budget) for the applicable Shared Product.

  • Territory Commercialization Budgets shall form part of, and be incorporated into, the Global Commercialization Budget and shall be reviewed, approved and updated as described in clauses 7.2.1, 7.2.2 and 9.2. In reviewing and approving the Territory Commercialization Budgets as part of the GCP and any Substantive Amendment thereto, the JSC (or the Executive Officers if applicable) shall refer to and consider each Party’s Commercialization Projection in accordance with clause 7.2.2(B).

  • The Global Commercialization Plans shall also include: (i) the applicable Global Commercialization Budget; (ii) the Territory Commercialization Plans for the applicable Licensed Product; (iii) the Territory Commercialization Budgets for the applicable Licensed Product; (iv) the Commercial Manufacturing and Supply Plan for the applicable Licensed Product in respect of activities after Regulatory Approval of that Licensed Product; and (v) the Global Pricing Strategy for each Licensed Product.

  • Such [*] shall also include a comparison of such estimated Net Sales to that Party’s Commercialization Projection and the applicable Global Commercialization Budget for the same period, with accompanying commentary.

  • If the Joint Commercialization Committee determines that such overrun is appropriate, the Joint Commercialization Committee shall submit to the Collaboration Committee for approval a revised Global Commercialization Budget so that no overrun is expected.

  • The 2021 Global Commercialization Budget and Country/Region Commercialization Budgets for Dupilumab, which implement the terms of this Fourth Amendment for 2021, are attached as Schedule A to the side letter dated as of the date hereof and by and among the same Parties (the “Side Letter”) (collectively, the “2021 Budgets”).


More Definitions of Global Commercialization Budget

Global Commercialization Budget means the budget(s) for a particular Contract Year approved by the JCC for the applicable Global Commercialization Plan. 1.51 "Global Commercialization Plan" shall mean, with respect to a Licensed Product, the three (3) year rolling plan approved by the JSC for Commercializing such Licensed Product throughout the world, including the related Global Commercialization Budget and a non-binding budget forecast for the next two (2) Contract Years, as the same may be amended from time-to-time in accordance with the terms of this Agreement. Each Global Commercialization Plan shall set forth (if not otherwise set forth in the applicable Country/Region Commercialization Plan(s)) for a Licensed Product, the information, plans and forecasts set forth in Section 6.2. 1.52 "Global Development Budget" shall mean the budget(s) for a particular Contract Year approved by the JSC for the applicable Global Development Plan. 1.53 "Global Development Plan" shall mean, with respect to a Licensed Product, the Initial Development Plan and the three (3) year rolling plan approved by the JSC for the worldwide Development of such Licensed Product, including the related Global Development Budget and a non-binding budget forecast for the next two (2) Contract Years, as the same may be amended from time-to-time in accordance with the terms of this Agreement. For the avoidance of doubt, a Global Development Plan will not include Non-Approval Trials. 1.54 "Good Practices" shall mean compliance with the applicable standards contained in then-current "Good Laboratory Practices," "Good Manufacturing Practices" and/or "Good Clinical Practices," as promulgated by the FDA and all analogous guidelines promulgated by the EMEA or the ICH, as applicable. 1.55 "Governmental Authority" shall mean any court, agency, authority, department, regulatory body or other instrumentality of any government or country or of any national, federal, state, provincial, regional, county, city or other political subdivision of any such government or any supranational organization of which any such country is a member. 1.56 "IAS/IFRS" shall mean International Accounting Standards/International Financial Reporting Standards of the International Accounting Standards Board. 1.57 "ICH" shall mean the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1.58 "IND" shall mean, with respect to each Licensed Product in the Field, an Investigational New Drug App...
Global Commercialization Budget has the meaning set forth in Section 3.3.2.