Common use of Annual Development Plans Clause in Contracts

Annual Development Plans. The initial Annual Development Plan shall be prepared by MERCK and submitted to the JSC for its review within [***] days of the date on which the JSC approves the selection of an Optimized Lead Compound and in any event, on or prior to the initiation of Development activities with respect thereto, which shall describe the Development activities to be conducted for the balance of the Contract Year. Thereafter, for each Contract Year during the Term, an Annual Development Plan for each Optimized Lead Compound and Development Candidate shall be prepared by MERCK and provided to the JSC for its review and MERCK shall consult with the JSC with respect to all significant Development decisions to be made with respect to such Annual Development Plan. Each Annual Development Plan shall: (a) set forth (i) the Development objectives, activities, and timelines for the Contract Year covered by the Annual Development Plan with reasonable specificity, (ii) which activities, if any, are ARCHEMIX Development Activities; provided, that, ARCHEMIX has agreed to perform such activities, (iii) with respect to such ARCHEMIX Development Activities, the number of FTEs estimated to be required to perform such activities and the corresponding FTE Cost and (iv) the expected Regulatory Filings and Drug Approval Applications to be prepared and filed and the expected timetable of completing such Development activities; and (b) be consistent with the other terms of this Agreement. Any Annual Development Plan may be amended from time to time by MERCK. Without limiting the nature or frequency of any other amendments, modifications or updates to the Annual Development Plan, the Annual Development Plan shall be updated at least once prior to the end of each Contract Year to describe the Development activities to be carried out by each Party during the applicable Contract Year in conducting the Development Program pursuant to this Agreement. Notwithstanding the above, the preparation and management of the Annual Development Plan by the JPT and JSC approval is only required for any Annual Development Plan or amendment thereto under which ARCHEMIX is responsible for performing any Development activities.

Annual Development Plans. The initial Annual Development Plan shall be prepared by MERCK and submitted Subject to the JSC for its review Section 4.11.1(c), within [***] days after the designation pursuant to Section 3.7 of the date on which the JSC approves the selection a Clinical Candidate eligible for designation as a Co-Developed Product, ELAN shall prepare an Annual Development Plan and budget for Development of an Optimized Lead Compound and in any event, on or prior to the initiation of Development activities with respect thereto, which shall describe the Development activities to be conducted such Clinical Candidate for the balance of the Contract YearYear during which the recommendation of such Clinical Candidate is approved. Thereafter, for each Contract Year during the TermTerm in which such Clinical Candidate is so eligible, and for each Co-Developed Product in the applicable Co-Development Territory, Indication and formulation, ELAN shall prepare and submit to the JMC for its review, an Annual Development Plan and Development Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 406 of the Securities Act. 50 budget for each Optimized Lead Compound and Development Clinical Candidate shall be prepared by MERCK and provided to the JSC for its review and MERCK shall consult with the JSC with respect to all significant Development decisions to be made with respect to such Annual Development Planand/or Co-Developed Product. Each Annual Development Plan shall: (a) set forth (i) the Development objectives, activities, priorities, timelines, budget and timelines resources for the Contract Year covered by the Annual Development Plan with reasonable specificity, (ii) which activities, if any, activities are ARCHEMIX Development Activities; provided, that, ARCHEMIX has agreed to perform such activities, (iii) with respect to such ARCHEMIX Development Activities, the number of FTEs estimated to be required to perform such activities and the corresponding FTE Cost Cost, and (iv) the expected Regulatory Filings and Drug Approval Applications to be prepared and filed and the expected timetable of completing such Development activities; and (b) be consistent with the other terms of this Agreement. Any The initial Annual Development Plan may shall be amended from time prepared by ELAN and submitted to time the JMC for its review within [***] days of the day on which the JMC approves the selection of a Clinical Candidate based on a Lead Compound and in any event, on or prior to the initiation of Development activities with respect to the initial Clinical Candidate. Each amendment, modification and update to any such Annual Development Plan shall include the resulting changes to the budget and shall be set forth in a written document prepared by MERCKELAN and submitted to the JMC, shall specifically state that it is an amendment, modification or update to that Annual Development Plan and shall be attached to the minutes of the meeting of the JMC at which such amendment, modification or update was reviewed by the JMC. Without limiting the nature or frequency of any other amendments, modifications or updates to the Annual Development Plan, the such Annual Development Plan shall be updated at least once prior to the end of each Contract Year in which an Annual Development Plan has been approved to describe the Development activities to be carried out by each Party during the applicable following Contract Year in conducting the applicable Development Program pursuant to this Agreement. Notwithstanding the above, the preparation and management of the Annual Development Plan by the JPT and JSC approval is only required for any Annual Development Plan or amendment thereto under which ARCHEMIX is responsible for performing any Development activities.