Common use of Overview; Development Plan Clause in Contracts

Overview; Development Plan. (a) From and after the Effective Date, MERRIMACK shall, except as provided in Section 4.2, be responsible for Development of the Licensed Compound and the Licensed Product, including all costs and expenses relating thereto. (b) Subject to and in accordance with the terms and conditions of this Agreement, including Section 4.2, the Parties shall collaborate on the Development of the Licensed Compound and the Licensed Product in accordance with the Development Plan. The initial Development Plan agreed to by the Parties is attached to this Agreement as Exhibit D and updates and amendments to such initial Development Plan, shall be prepared by MERRIMACK, in consultation with PEI, shall be reviewed and approved by the JDC and JSC, shall be consistent with the terms and conditions of this Agreement and shall specify, among other things: (i) Development objectives; (ii) activities to be performed, including all Clinical Trials and Regulatory Approvals required for Commercializing the Licensed Product in the MERRIMACK Territory and PEI Territory; (iii) the Party responsible for performance of an activity (provided that, except with respect to the Ongoing Clinical Studies, PEI shall only be assigned Development activities with the mutual agreement of the Parties); (iv) associated budgets for the Development activities to be conducted by MERRIMACK and PEI; (v) timelines for performance; and (vi) specific deliverables. (c) Each Party shall use Commercially Reasonable Efforts to perform its respective obligations under the Development Plan in accordance with the Development Plan and all applicable Laws. (d) MERRIMACK shall be responsible for all costs of conducting the Development Program after the Effective Date (other than any activities conducted by PEI in accordance with Section 4.2(b)(iii)), including Manufacturing Costs, and shall pay PEI in accordance with Section 9.9 for Development Costs incurred by PEI in performing activities assigned to PEI under the Development Plan; provided the amounts involved are within the budget in the Development Plan for such activities.

Overview; Development Plan. (a) From and after the Effective Date, MERRIMACK shall, except as provided in Section 4.2, be responsible for Development of the Licensed Compound and the Licensed Product, including all costs and expenses relating thereto. (b) Subject to and in accordance with the terms and conditions of this Agreement, including Section 4.23.2, the Parties shall collaborate on the Development research and development of the Collaboration Compound(s) and Licensed Compound and the Licensed Product Product(s) in accordance with the Global Development Plan. The initial Global Development Plan agreed to by the Parties is attached to this Agreement as Exhibit D Plan, and updates and amendments to such initial each successive Global Development Plan, shall be prepared by MERRIMACK, SANOFI-AVENTIS in consultation with PEIMERRIMACK, shall be reviewed and approved by the JDC and JSC, shall be consistent with the terms and conditions of this the Agreement and shall specify, with a breakdown by Major Territory and the rest of the Territory, if relevant, among other things: (i) Development research and development objectives;, (ii) activities to be performed, including all Clinical Trials clinical trials and Regulatory Approvals required for Commercializing the manufacturing, marketing and selling Licensed Product in the MERRIMACK Territory and PEI Territory;Products, (iii) the Party responsible for performance of an activity (provided that, except with respect to the Ongoing Clinical Studies, PEI shall only be assigned Development activities with the mutual agreement of the Parties);activity, (iv) associated budgets for the Development next [**] years, regarding development activities to be conducted by MERRIMACK and PEI;hereunder, (v) timelines for performance; , and (vi) specific deliverables. (cb) Each Party shall use Commercially Reasonable Efforts to perform its respective obligations under the Global Development Plan in accordance with the Global Development Plan and all applicable Laws. (dc) MERRIMACK SANOFI-AVENTIS shall be responsible for all costs of conducting the Development Program after the Effective Date (other than any activities conducted by PEI in accordance with Section 4.2(b)(iii))Program, including Manufacturing Costs, and shall pay PEI in accordance with Section 9.9 MERRIMACK, within [**] days following MERRIMACK’s invoice, for Development Costs (i) all internal costs of MERRIMACK personnel at the FTE Rate, plus (ii) all out-of-pocket costs and expenses incurred by PEI MERRIMACK, including costs and expenses of any Third Party contract research and manufacturing organizations, with respect to each of clause (i) and (ii) to the extent incurred in performing activities assigned to PEI MERRIMACK under the Global Development Plan; Plan and provided (x) the applicable activities relating to conducting the Development Program have been previously approved by the JSC prior to their start and (y) the amounts involved are within the approved budget, (it being understood that the approved budget shall include an allowance of [**] percent ([**]%) for cost overruns), provided such overruns, upon their occurrence, are appropriately documented and justified. It is further understood that MERRIMACK’s obligations to perform any given Development Program activities shall be subject to prior approval by the JSC of a budget therefor. For purposes of this Agreement, an overrun shall be justified if it is incurred by Merrimack in activities that are pursuant to the Global Development Plan for such activitiesapproved by the JSC and the objectives thereof. All budgets established by the JSC relating to the conduct of activities by MERRIMACK pursuant to Section 3.2(c), Section 3.4(a), Section 4.1(a) and Section 4.1(b) shall be consistent with, but in any case not superior than, a budget of SANOFI-AVENTIS covering the conduct of comparable activities by and/or on behalf of SANOFI-AVENTIS.