Amgen Costs. Within forty-five (45) days after the end of each calendar quarter Amgen will provide to Partner a detailed, itemized report of its Development Costs and General Costs, on a Product-by-Product basis, incurred by Amgen or its Affiliates in accordance with this Agreement (collectively, “Amgen Costs”) in such quarter in the format set forth in the Invoice Schedule attached hereto. In addition to the annual JSC approval of the relevant budgets for each Product, prior to the end of each calendar year, Amgen will provide Partner with a non- binding estimate of its Development Costs and General Costs for each Product for the [*] period (detailed on a calendar year basis) following the [*] covered by such approved budget; provided, that the Parties will review and discuss such estimated costs at the JSC. For clarity, any costs incurred by or on behalf of Amgen in connection with the research and development of AMG557 for the sole benefit of Japan or the research and development of AMG827 for the sole benefit of the applicable Excluded Territory will not be included in Amgen Costs.
Amgen Costs. Within [*] after the end of each calendar quarter, Amgen will provide to BeiGene a final report of its Commercialization and Related Costs, on a Product-by-Product basis, incurred by Amgen or its Affiliates in accordance with this Agreement (collectively, “Amgen Costs”) in such quarter. Amgen will initially incur the Manufacturing Actual Costs and the portion of the Commercialization and Related Costs attributed to its activities hereunder. In addition to the annual Commercialization Budget approved hereunder, prior to the end of each calendar year, Amgen will provide BeiGene with a nonbinding estimate of its Commercialization and Related Costs for the [*] period (detailed on a calendar year basis) following the year covered by such approved budgets; provided that the Parties will review and discuss such estimated costs at the JSC. Within [*] after the end of each calendar quarter, Amgen will provide BeiGene with a report of any Recoveries for such calendar quarter.
Amgen Costs. Within forty-five (45) days of the end of each calendar quarter Amgen will provide GSK a detailed, itemized report of the costs described in Sections 6.1.2.1 through 6.
Amgen Costs. Within forty-five (45) days of the end of each calendar quarter Amgen will provide GSK a detailed, itemized report of the costs described in Sections 6.1.2.1 through 6.1.2.13 (collectively “Amgen Costs”) incurred in such format as designated by the JSC. Within five (5) days prior to the end of each calendar quarter Amgen will provide GSK an estimate of Amgen Costs incurred and to be incurred in such quarter, and an estimate of Amgen Costs to be incurred in the remaining quarters of such calendar year, in each case in such format as designated by the JSC. All Amgen Costs incurred on or after [*] will be included in the profit/expense sharing provisions of this Article 6 (Profit/Expense Sharing).
6.1.2.1. Costs incurred by Amgen or its Affiliates in performing activities allocated to Amgen pursuant to Section 3.4 (Designated Amgen Activities) or 3.1 (Allocation of Operational Responsibility) and not otherwise included in this Section 6.1.2 (Amgen Costs);
6.1.2.2. Any amounts paid by Amgen to Third Parties for rights to manufacture, use or sell Ivory in or for the Collaboration Scope to the extent not already included in COGS [*];
6.1.2.3. Costs associated with obtaining, maintaining and renewing Regulatory Filings and Regulatory Approvals pertaining to Ivory;
6.1.2.4. Training costs incurred in accordance with Section 3.8 (Training);
6.1.2.5. Amgen Sales Force Costs incurred in accordance with the Brand Plan and calculated in accordance with Section 6.1.10 (Calculation of Sales Force Costs);
6.1.2.6. COGS associated with Ivory Net Revenues;
6.1.2.7. [*] of Qualified Amgen R&D Costs;
6.1.2.8. Collaboration Territory R&D Costs;
6.1.2.9. Standard Cost of any Samples of Ivory provided in the Collaboration Scope;
6.1.2.10. Costs associated with any recalls, returns and withdrawals of Ivory in the Collaboration Scope that are not attributable to Amgen’s or its Affiliates’ negligence or willful misconduct or Amgen’s breach of this Agreement;
6.1.2.11. Defense costs incurred within or materially related to the Collaboration Scope in accordance with Section 9.7 (Defense and Settlement of Third Party Claims) or 13.5 (Defense of Third Party Claims) (but, in each case, not including defense costs incurred by Amgen in fulfilling its obligations pursuant to Section 13.2 (Indemnity by Amgen)) and enforcement (and cooperation) costs incurred in accordance with Section 9.8 (Enforcement) within or materially related to the Collaboration Scope;
6.1.2.12. Amgen’s costs incurred...
Amgen Costs. Within [***] days after the end of each calendar quarter, Amgen will provide to KKUS a final report of its Global Development Costs incurred by Amgen in accordance with this Agreement (collectively, “Amgen Development Costs”) in such quarter in the Amgen Territory. Amgen will initially bear the Global Development Costs attributed to its activities hereunder prior to any rebalancing payments therefor pursuant to Section 8.2.3 (Global Development Cost Share) In addition to the annual Global Development Budget approved hereunder, prior to the end of each calendar year, Amgen will provide KKUS with a nonbinding good faith estimate of the anticipated Global Development Costs expected to be incurred by Amgen in the Amgen Territory for the [***]year period (detailed on a calendar year basis) following the year covered by such approved budgets; provided that the Parties will review and discuss such estimated Costs at the JDS.
Amgen Costs. Within [***] days after the end of each calendar quarter, Amgen will provide to KKUS a final report of its Commercialization and Related Costs incurred by Amgen or its Affiliates in accordance with this Agreement (collectively, “Amgen Commercialization Costs”) in such quarter in connection with the Commercialization of Products in the U.S. Amgen will initially bear such Commercialization and Related Costs attributed to its activities hereunder prior to any balancing repayments therefor pursuant to Section 8.3.4 (Balancing Payment for Commercialization and Related Costs). In addition to the annual Commercialization Budget approved hereunder, prior to the end of each calendar year, Amgen will provide KKUS with a nonbinding estimate of its Commercialization and Related Costs for the [***]year period (detailed on a calendar year basis) following the year covered by such approved budgets; provided that the Parties will review and discuss such estimated costs at the JCS.
