Annual Development Plans Sample Clauses
Annual Development Plans. Subject to Section 4.11.1(c), within [***] days after the designation pursuant to Section 3.7 of a Clinical Candidate eligible for designation as a Co-Developed Product, ELAN shall prepare an Annual Development Plan and budget for Development of such Clinical Candidate for the balance of the Contract Year during which the recommendation of such Clinical Candidate is approved. Thereafter, for each Contract Year during the Term 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. budget for each Clinical Candidate and/or Co-Developed Product. Each Annual Development Plan shall: (a) set forth (i) the Development objectives, activities, priorities, timelines, budget and resources for the Contract Year covered by the Annual Development Plan with reasonable specificity, (ii) which activities are ARCHEMIX Development 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. The initial Annual Development Plan shall be prepared by ELAN and submitted to 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 ELAN 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 amend...
Annual Development Plans. (a) Plan and Content of the Aveo Annual Development Plan. Each calendar year, Aveo shall conduct Licensed Product development activities for the Aveo Territory in accordance with the Aveo Annual Development Plan for the year that Aveo shares with Kirin in advance, as such plan may be modified during the course of the year. Aveo’s 2007 Aveo Annual Development Plan has previously been provided to Kirin. Aveo shall annually present an updated Aveo Annual Development Plan to the Development Committee for discussion and feedback beginning in 2008. No later than thirty (30) days prior to the annual Development Committee meeting, Aveo shall deliver the Aveo Annual Development Plan to Kirin. Aveo shall include in each Aveo Annual Development Plan: (1) a summary of its activities in the prior year (including all Aveo Product Inventions from that year; clinical trials from which final reports are available; and Licensed Product Biomarkers discovered); and (2) its detailed plan for Licensed Product development in the next years (including clinical trials that will be commenced (including their proposed protocols if already prepared); clinical trials that are expected in the next year to be completed; material meetings with Regulatory Agencies; and Marketing Approval Applications planned for filing.
Annual Development Plans. Within thirty (30) days following its formation, the JSC shall prepare and approve an annual development plan and budget (the "Annual Development Plan and Budget") addressing the collaborative Screening, Research and Development activities to be carried out by the Parties during the remainder of calendar year 1999 pursuant to this Agreement and the Global Research and Development Plan. Thereafter, on or before October 31 of each year, the JSC shall prepare and approve an Annual Development Plan and Budget addressing the collaborative Screening, Research and Development activities to be undertaken by the Parties during the following calendar year pursuant to this Agreement and the then current Global Research and Development Plan. Each Annual Development Plan and Budget shall include, without limitation, detailed plans for the characterization and validation of Targets that may become Collaboration Targets, the discovery and validation of Compounds which are directed against Active Collaboration Targets for use in the Field, the collaborative research and development of Compounds and Products which are directed against Active Collaboration Targets for use in the Field, designation of which Party is responsible for each task, staffing levels required to carry out such activities, and a budget setting forth the estimated expenditures required to carry out such
Annual Development Plans. Within thirty (30) days following its formation, the JSC shall prepare and approve an annual development plan and budget (the "Annual Development Plan and Budget") addressing the collaborative Screening, Research and Development activities to be carried out by the Parties during the remainder of calendar year 1999 pursuant to this Agreement and the Global Research and Development Plan. Thereafter, on or before October 31 of each year, the JSC shall prepare and approve an Annual Development Plan and Budget addressing the collaborative Screening, Research and Development activities to be undertaken by the Parties during the following calendar year pursuant to this Agreement and the then current Global Research and Development Plan. Each Annual Development Plan and Budget shall include, without limitation, detailed plans for the characterization and validation of Targets, the discovery and validation of Compounds for use in the Field, the collaborative research and development of Compounds and Products for use in the Field, designation of which Party is responsible for each task, staffing levels required to carry out such activities, and a budget setting forth the estimated expenditures required to carry out such activities. The Annual Development Plan and Budget may only be modified or amended upon written approval of the JSC.
Annual Development Plans