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 Effective Date, but in any event within The OLP Development Plan will contain a [...***...] days thereafterrolling budget covering the anticipated Development activities to be performed during the then-current Calendar Year (broken down by Calendar Quarter) and the next Calendar Year (broken down by Calendar Quarter), and concurrently with the preparation a forecast of the budgets for each subsequent Calendar Year thereafter through completion of all Development activities set forth in any such OLP Development Plan, provided that the initial OLP Development Plan pursuant to will also include such a budget for the partial Calendar Year commencing as of the date of such OLP Development Plan and ending December 31 of such Calendar Year (each such one year budget plus any such partial Calendar Year is a “OLP Development Budget”). Each OLP Development Budget will be updated [...***...] by the JDC in accordance with Section 3.1(a), the Parties shall cooperate to prepare the initial 5.3. 2.1. The OLP Development Budget, which shall and each update thereto, will be reviewed and approved prepared by the JSC. The Lead US Party shall be responsible for JDC, based on (a) the preparation Parties’ good faith estimation of the applicable portion of anticipated OLP Development Activities to be conducted during the budget relevant [...***...] period and (b) information prepared by the Parties in good faith for the their own internal planning processes relating to anticipated Development activities, including all Clinical Trials, to a summary of which will 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 provided 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 JDC 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 incorporation into the OLP Development Budget. The OLP Development Budget reasonably in advance will include an itemized list of the applicable Development Costs or Manufacturing Costs or other Allowable Expenses being incurred (with activities to be performed during the intent being to obtain such approval at least [...***...] months in advance of covered by such costs being incurred, where practicable). Thereafter, the JSC will update and provide the JDC with a copy of the OLP Development Budget, including with detailed line item entries for each Development activity setting forth 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 costs directly related to such Additional Development activity (broken out to show Out-of-Pocket Costs and FTE Costs for FTEs directly engaged to perform such Development activity) and specifying what Party or Third Party is responsible for performing the applicable Development activity, which itemized list may include: (a) Any material preclinical, non-Clinical Studies or GLP toxicology studies, itemized by study, and (b) Clinical Studies, including (A) the following costs itemized by Clinical 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)if applicable: itemized cost of study drug (if available), after which time any changes to per- patient costs (if available), study initiation costs, per-protocol costs, investigator payments, monthly study fixed costs, statistical analysis costs, study report development costs and study close-out expenses and (B) 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 Planfollowing information itemized by Clinical Study: number of study sites and number of patients.

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.