Common use of Development Budgets Clause in Contracts

Development Budgets. Promptly after the Effective Date, but in any event within [***] days thereafter, and concurrently with the preparation of the Development Plan pursuant to Section 3.1(a), the Parties shall cooperate to prepare the initial Development Budget, which shall be reviewed and approved by the JSC. The Lead US Party shall be responsible for the preparation of the applicable portion of the budget for the Development activities, including all Clinical Trials, to be conducted solely to support Regulatory Approval of Shared Products in the US Territory, and Celgene shall be responsible for the preparation of the portion of the budget for the Development activities, including all Clinical Trials, to be conducted solely to support Regulatory Approval of Shared Products in the ROW Territory. All reasonable Direct Costs incurred by either Party or its Affiliates in conducting (i) Development activities pursuant to the Development Plan, or (ii) Additional Studies that the Parties agree to conduct pursuant to Section 3.3 following the Agreement Effective Date shall be considered Development Costs or Manufacturing Costs or other Allowable Expenses, as applicable, and shall be included in Allowable Expenses for the purposes of calculating the Profit & Loss Share. For Development Costs and related Manufacturing Costs and other Allowable Expenses to be incurred from and after the Effective Date, the JSC will review and approve the Development Budget reasonably in advance of the applicable Development Costs or Manufacturing Costs or other Allowable Expenses being incurred (with the intent being to obtain such approval at least [***] months in advance of such costs being incurred, where practicable). Thereafter, the JSC will update and provide the JDC with a copy of the Development Budget, including the budgeted Development Costs and related Manufacturing Costs and other Allowable Expenses, each Calendar Year at a meeting of the JDC sufficiently in advance of the next Calendar Year so as to provide the Parties with an opportunity to budget accordingly, but in any event no later than November 1st of each Calendar Year during the Term. The JSC will review and approve any such update or any other amendment to the Development Budget. In addition, either Party may request at any time that the JDC consider, and the JSC approve, other updates to the Development Budget. The Parties understand and agree that, if the Non-Proposing Party does not elect to participate in an Additional Study as set forth in Section 3.3, the Proposing Party shall have the sole right to amend the Development Budget to account for the Direct Costs of such Additional Study (but, for clarity, shall not have the right to impose any additional payment obligations on the Non-Proposing Party for expenses related to such Additional Study, unless and until a Co-Co Buy-In occurs as set forth in Section 3.4, or a Deemed Buy-In occurs pursuant to Section 3.3(c)), after which time any changes to the Development Budget shall be run through the procedures described in this Section 3.1(b). Each Party shall use Commercially Reasonable Efforts to perform the activities assigned to it in the Development Plan.

Development Budgets. Promptly after the Effective Date, but in any event within [***] days thereafter, and concurrently with the preparation of the Development Plan pursuant to Section 3.1(a3.2(a), Celgene shall prepare and submit to the Parties shall cooperate to prepare JDC for review the initial Development Budget, which shall be reviewed and approved by the JSC. The Lead US Party Celgene shall be solely responsible for the preparation of the applicable portion of the budget for the Development activities, including all Clinical Trials, to be conducted solely to support Regulatory Approval of Shared Products in the US Territory, and Celgene shall be responsible for the preparation of the portion of the budget for the Development activities, including all Clinical Trials, to be conducted solely to support Regulatory Approval of Shared Products in the ROW TerritoryAdministration. All reasonable Direct Costs incurred by either Party or its Affiliates in conducting (i) Development activities pursuant to the Development Plan, or (ii) Additional Studies that the Parties agree to conduct pursuant to Section 3.3 following the Agreement Effective Date shall be considered For Worldwide Development Costs or Manufacturing Costs or other Allowable Expenses, as applicable, and shall be included in Allowable Expenses for the purposes of calculating the Profit & Loss Share. For Development Costs and related Manufacturing Costs and other Allowable Expenses to be incurred from and after the Effective Date, the JSC will review and approve the Development Budget reasonably in advance of the applicable Worldwide Development Costs or Manufacturing Costs or other Allowable Expenses being incurred (with the intent being to obtain such approval at least [***] months in advance of such costs being incurred, where practicable). Thereafter, the JSC JDC will update and provide the JDC JSC with a copy of the Development Budget, including the budgeted Worldwide Development Costs and related Manufacturing Costs and other Allowable ExpensesCosts, each Calendar Year at a meeting of the JDC JSC sufficiently in advance of the next Calendar Year so as to provide the Parties with an opportunity to budget accordingly, but in any event no later than November 1st of each Calendar Year during the Term. The JSC will review and approve any such update or any other amendment to the Development Budget. In addition, either Party may request at any time that the JDC consider, and the JSC approve, other updates to the Development Budget. The Parties understand and agree that, if the Non-Proposing Party Vividion does not elect to participate in an Additional Study as set forth in Section 3.33.4, the Proposing Party Celgene shall have the sole right to amend the Development Budget to account for the Direct Costs of such Additional Study (but, for clarity, shall not have the right to impose any additional payment obligations on the Non-Proposing Party Vividion for expenses related to such Additional Study, unless and until a Co-Co Buy-In occurs as set forth in Section 3.43.5, or a Deemed Buy-In occurs pursuant to Section 3.3(c3.4(c)), after which time any changes to the Development Budget shall be run through the procedures described in this Section 3.1(b3.2(b). Subject to this Section 3.2(b) and Sections 3.4 and 3.5, all reasonable Direct Costs (including Out-of-Pocket Costs) arising from either Party’s conduct of Development with respect to the Shared Program in accordance with the Development Plan and the Development Budget that qualify as Worldwide Development Costs shall be subject to the Development Cost Share. Each Party shall use Commercially Reasonable Efforts to perform the activities assigned to it in the Development Plan.

Development Budgets. Promptly after The Territory Development Plan shall include the Effective DateTerritory Development Budget and the Global Development Plan shall include the Global Development Budget (each individually, but in any event within [***] days thereaftera “Development Budget” and both collectively, the “Development Budgets”) and concurrently with the preparation Development Budgets shall be prepared, updated, reviewed and approved as part of the preparation, update and approval of the Development Plan pursuant Plans in accordance with this Agreement. Amendments and updates to Section 3.1(aany Development Budgets shall not be effective without the approval of the JSC. In the event that, during any Contract Year (the “First Year”), any Development activity expressly provided for in the Parties shall cooperate approved Development Budget to prepare be completed during such First Year is not completed during such First Year (to the initial Development Budgetextent incomplete, which an “Incomplete Activity”) and the full expense budgeted for such activity for such First Year is not incurred (to the extent not incurred, a “Non-Incurred Amount”), then such Incomplete Activity shall be reviewed completed during Contract Years following such First Year (the “Succeeding Year(s)”) and the Non-Incurred Amount shall be included in the Development Budget for such Succeeding Year(s) as set forth in the following sentence. If the Development Budget for such Succeeding Year(s) has not yet been approved by the JSC. The Lead US Party , then the Non-Incurred Amount shall be responsible for the preparation of the applicable portion of the budget for the Development activities, including all Clinical Trials, to be conducted solely to support Regulatory Approval of Shared Products included in the US Territory, and Celgene shall be responsible proposed Development Budget for the preparation of the portion of the budget for the Development activities, including all Clinical Trials, to be conducted solely to support Regulatory Approval of Shared Products in the ROW Territory. All reasonable Direct Costs incurred by either Party or its Affiliates in conducting (isuch Succeeding Year(s) without otherwise limiting any other Development activities or any amounts related thereto, unrelated to the Incomplete Activity, which, pursuant to the Development Plan, or (ii) Additional Studies that the Parties agree to conduct pursuant to Section 3.3 following the Agreement Effective Date shall be considered Development Costs or Manufacturing Costs or other Allowable Expenses, as applicablewould have been performed during such Succeeding Year, and shall be included in Allowable Expenses for the purposes of calculating the Profit & Loss Share. For Development Costs and related Manufacturing Costs and other Allowable Expenses to be incurred from and after the Effective Date, the JSC will review and approve if the Development Budget reasonably in advance of for the applicable Development Costs or Manufacturing Costs or other Allowable Expenses being incurred (with Succeeding Year(s) has been approved by the intent being to obtain such approval at least [***] months in advance of such costs being incurredJSC, where practicable). Thereafter, the JSC will update and provide the JDC with a copy of then the Development Budget, including the budgeted Development Costs and related Manufacturing Costs and other Allowable Expenses, each Calendar Year at a meeting of the JDC sufficiently in advance of the next Calendar Year so as Budget for such Succeeding Year(s) shall be revised automatically to provide the Parties with an opportunity to budget accordingly, but in any event no later than November 1st of each Calendar Year during the Term. The JSC will review and approve any such update or any other amendment to the Development Budget. In addition, either Party may request at any time that the JDC consider, and the JSC approve, other updates to the Development Budget. The Parties understand and agree that, if include the Non-Proposing Party does not elect to participate in an Additional Study as set forth in Section 3.3, the Proposing Party shall have the sole right to amend the Development Budget to account for the Direct Costs of such Additional Study (but, for clarity, shall not have the right to impose any additional payment obligations on the Non-Proposing Party for expenses related to such Additional Study, unless and until a Co-Co Buy-In occurs as set forth in Section 3.4, or a Deemed Buy-In occurs pursuant to Section 3.3(c)), after which time any changes to the Development Budget shall be run through the procedures described in this Section 3.1(b). Each Party shall use Commercially Reasonable Efforts to perform the activities assigned to it in the Development PlanIncurred Amount.

Development Budgets. Promptly after the Effective Date, but in any event within [***] days thereafter, and concurrently with the preparation of the Development Plan pursuant to Section 3.1(a), the Parties shall cooperate to prepare the initial Development Budget, which shall be reviewed and approved by the JSCJDC (provided that, in the event that the JDC is unable to agree upon and approve the initial Development Budget proposal, the applicable Lead Party shall be entitled to approve such proposed Development Budget for its respective portion of the Territory). The Lead US Party shall be responsible for the preparation of the applicable portion of the budget for the Development activitiesactivities for, including all Clinical Trials, to be conducted solely Trials to support Regulatory Approval of Shared Licensed Products in in, the US TerritoryUnited States, and Celgene shall be responsible for the preparation of the portion of the budget for the Development activities, including all Clinical Trials, to be conducted solely Trials to support Regulatory Approval of Shared Licensed Products in in, the ROW Territory. All reasonable Direct Costs incurred by either Party or its Affiliates in conducting (i) Development activities pursuant to the Development Plan, or (ii) Additional Studies that the Parties agree to conduct pursuant to Section 3.3 following the Agreement Effective Date shall be considered Development Costs or Manufacturing Costs or other Allowable Expenses, as applicable, and shall be included in Allowable Expenses for the purposes of calculating the Profit & Loss Share. For Development Costs and related Manufacturing Costs and other Allowable Expenses to be incurred from and after the Effective Date, the JSC JDC will review and approve the Development Budget reasonably in advance of the applicable Development Costs or Manufacturing Costs or other Allowable Expenses being incurred (with the intent being to obtain such approval at least [***] months in advance of such costs being incurred, where practicable). Thereafter, the JSC JDC will update and provide the JDC JSC with a copy of the Development Budget, including the budgeted Development Costs and related Manufacturing Costs and other Allowable ExpensesCosts, each Calendar Year at a meeting of the JDC JSC sufficiently in advance of the next Calendar Year so as to provide the Parties with an opportunity to budget accordingly, but in any event no later than November 1st [**] of each Calendar Year during the Term. The JSC will review and approve any such update or any other amendment to the Development Budget. In addition, either Party may request at any time that the JDC consider, and the JSC approve, other updates to the Development Budget. The Development Budget may be amended from time to time either by agreement between the Parties through the JSC or by the Lead Party in the event that the JSC is unable to agree upon and approve any such amendment or updates for its respective portion of the Territory, provided that, subject to the terms and conditions of this Agreement, the Parties agree that each Party shall consider any reasonable comments made by either Party in relation to the Development of Licensed Products either within or outside the territory for which such Party is the Lead Party. The Parties understand and agree that, if the Non-Proposing Party does not elect to participate in an Additional Study as set forth in Section 3.3, the Proposing Party shall have the sole right to amend the Development Budget to account for the Direct Costs costs of such Additional Study (but, for clarity, shall not have the right to impose any additional payment obligations on the Non-Proposing Party for expenses related to such Additional Study, unless and until a Co-Co Buy-In occurs as set forth in Section 3.4, or a Deemed Buy-In occurs pursuant to Section 3.3(c)), after which time any changes to the Development Budget shall be run through the procedures described in this Section 3.1(b). Each Party shall use Commercially Reasonable Efforts to perform the activities assigned to it in the Development Plan.