Common use of Annual Research Plans Clause in Contracts

Annual Research Plans. The initial Annual Research Plan and budget, which describes the research activities to be carried out by each Party during the first Fiscal Year of the Research Program Term for the initial Program Targets shall be prepared by the JPT and submitted to, and approved by, the JSC within [***] days of the Effective Date. For each subsequent Fiscal Year during the Research Program Term commencing with the second Fiscal Year, an Annual Research Plan and budget shall be prepared by or at the direction of the JPT and submitted to the JSC for its approval. The JPT shall manage the preparation of each Annual Research Plan in a manner designed to obtain JSC approval no later than [***] days prior to the end of the then-current Fiscal Year. Each Annual Research Plan shall: (a) set forth (i) the research objectives and activities to be performed for the Fiscal Year covered by the Annual Research Plan with reasonable specificity, (ii) the research plans and protocols to be employed to complete each stage of the Research Program, (iii) changes to the OLSC for each Program Target and any other criteria that the JPT utilizes to evaluate the results of the Research Program in order to nominate Optimized Lead Compounds for Program Targets, (iv) the Party that shall be responsible for performing such activities, (v) a timeline and budget for such activities (including any Third Party Costs), and (vi) with respect to ARCHEMIX Research Activities, the number of FTEs estimated to be required to perform such activities, and (b) shall be consistent with the other terms of this Agreement. Without limiting the generality of the foregoing, the objectives of each Annual Research Plan shall include, as appropriate from time to time during the Research Program Term, conducting the necessary research activities to identify Program Aptamers or to determine whether Program Aptamers should be nominated to the JSC as Optimized Lead Compounds. Any Annual Research Plan may be amended from time to time by the JSC pursuant to Section 2.1.4. Each amendment, modification and update to the Annual Research Plan shall include the resulting changes to the budget, including the number of FTEs to be utilized by ARCHEMIX, and shall be set forth in a written document prepared by, or at the direction of, the JPT and approved by the JSC, shall specifically state that it is an amendment, modification or update to the Annual Research Plan and shall be attached to the minutes of the meeting of the JSC at which such amendment, modification or update was approved by the JSC. Without limiting the nature or frequency of any other amendments, modifications or updates to the Annual Research Plan that may be approved by the JSC, the Annual Research Plan shall be updated at least once prior to the end of each Fiscal Year to describe the research activities to be carried out by each Party during the upcoming Fiscal Year during the Research Program Term in conducting the Research Program pursuant to this Agreement.

Appears in 2 contracts

Samples: Collaborative Research and License Agreement (Archemix Corp.), Collaborative Research and License Agreement (Nitromed Inc)

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Annual Research Plans. The initial Annual Research Plan Plans and budget, which describes the research activities to be carried out by each Party during the first Fiscal Year of the Research Program Term budgets for the initial Program Targets MERCK Funded Research Projects and, if applicable, the MERCK Internal Research Projects shall be prepared developed by the JPT and submitted toJPT, and approved by, by the JSC within [***] days and attached as exhibits to the minutes of the Effective Date. For each subsequent Fiscal Year during JSC meeting at which such JSC approval is obtained as soon as practicable after the Research Program Term commencing with the second Fiscal Year, an Annual Research Plan and budget shall be prepared acceptance by or at the direction ARCHEMIX of the JPT applicable Target proposed by MERCK for inclusion on the Target Exclusivity List as provided in Sections 3.8.1 and submitted to the JSC for its approval3.8.2. The JPT shall manage the preparation of each the subsequent Annual Research Plan Plans in a manner designed to obtain JSC approval no later than [***] days prior to the end of the then-current Fiscal Contract Year. Each Annual Research Plan shall: (a) set forth (i) the research objectives and activities to be performed for the Fiscal Research Project and Contract Year covered by the Annual Research Plan with reasonable specificity, (ii) the research plans and protocols to be employed to complete each stage of the applicable Research ProgramProject, (iii) changes to the OLSC for each Program Target and any other criteria that the JPT utilizes will utilize to evaluate the results of the Research Program in order Project to nominate Optimized Lead Compounds for Program TargetsCompounds, (iv) the Party that shall be responsible for performing such activities, (v) a timeline and budget for such activities (including any Third Party CostsCosts to be incurred for outsourced studies managed by ARCHEMIX or MERCK), and (vi) with respect to ARCHEMIX Research Activities, the number of FTEs estimated to be required to perform such activities, ; and (b) shall be consistent with the other terms of this Agreement. Without limiting the generality of the foregoing, the objectives of each Annual Research Plan shall include, as appropriate from time to time during the Research Program Term, conducting the necessary research activities to identify Program Aptamers Lead Compounds or to determine whether Program Aptamers Lead Compounds should be nominated to the JSC as Optimized Lead Compounds. Any Annual Research Plan may be amended from time to time by the JPT pursuant to Section 2.2.4 or by the JSC pursuant to Section 2.1.4. Each amendment, modification and update to the Annual Research Plan shall include the resulting changes to the budget, including the number of FTEs to be utilized by ARCHEMIX, and shall be set forth in a written document prepared by, or at the direction of, the JPT and approved by the JSC, shall specifically state that it is an amendment, modification or update to the Annual Research Plan and shall be attached to the minutes of the meeting of the JSC at which such amendment, modification or update was approved by the JSC. Without limiting the nature or frequency of any other amendments, modifications or updates to the Annual Research Plan that may be approved by the JSC, the Annual Research Plan shall be updated at least once prior to the end of 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. 37 each Fiscal Contract Year to describe the research activities to be carried out by each Party during the upcoming Fiscal applicable Contract Year during the Research Program Term in conducting the Research Program pursuant to this Agreement. Notwithstanding anything to the contrary in this Agreement, ARCHEMIX shall have sole responsibility for all research activities associated with ARCHEMIX Internal Program Targets and neither MERCK nor the JSC shall have any right to prepare, review or approve any research plans covering any Optimized Lead Compound researched and/or developed under an ARCHEMIX Internal Research Project, until such time as MERCK pays the Option Exercise Fee applicable to the designation of such Optimized Lead Compound as a Development Candidate pursuant to Section 6.3, subject to MERCK’s right to provide an Additional Research Request pursuant to Section 3.9.2.

Appears in 2 contracts

Samples: Collaborative Research and License Agreement (Archemix Corp.), Collaborative Research and License Agreement (Nitromed Inc)

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Annual Research Plans. The initial Annual Research Plan and budget, which describes the research activities to be carried out by each Party during for the first Fiscal Contract Year of the Research Program Term for the initial Program Targets shall be prepared has been agreed upon in writing by the JPT and submitted to, and approved by, the JSC within [***] days of the Effective DateParties. For each subsequent Fiscal Year during the Research Program Term commencing with the second Fiscal Year, an An Annual Research Plan and budget for each subsequent Contract Year for each DS Target shall be prepared by or at the direction of the JPT and submitted to JRC, approved by the JSC for its approval. The JPT shall manage the preparation of each Annual Research Plan in a manner designed to obtain JSC approval JEC no later than [***] days prior to the end of the then-current Fiscal Yearthird quarter of the preceding Contract Year and attached as an exhibit to the minutes of the JEC meeting at which such JEC approval is obtained. As soon as practicable after the designation of any additional DS Target the JRC shall prepare an update to the Annual Research Plan as provided in Section 3.5.2(d). Each Annual Research Plan shall: (a) set forth (i) the research objectives and activities to be performed for each Research Stage of the Fiscal Research Program for the Contract Year covered by the Annual Research Plan with reasonable specificity, ; (ii) the research plans and protocols to be employed to complete each stage such Research Stage, including without limitation a description of the Research Programtypes of assays (in silico, in vitro or in vivo) to be developed and used by the Parties; (iii) changes to the OLSC for each Program Target and any other criteria Advancement Criteria that the JPT utilizes JRC will utilize to evaluate the results of each Research Stage and to determine whether to Advance Collaboration Compounds to the next Research Program in order to nominate Optimized Lead Compounds for Program Targets, Stage; (iv) the Party that shall be responsible for performing such activities, the activities described for each Research Stage; (v) a timeline and budget for such activities (including any Third Party CostsCosts to be incurred for outsourced Research activities managed by ARQULE or DS), ; and (vi) with respect to ARCHEMIX ARQULE Research Activities, the number of FTEs estimated to be required to perform such activities, applicable FTE Funding Commitment; and (b) shall be consistent with the other terms of this Agreement. Without limiting the generality of the foregoing, the objectives of each Annual Research Plan shall include, as appropriate from time to time during the Research Program Term, conducting the necessary research activities to identify Program Aptamers or to determine whether Program Aptamers should be nominated Subject to the JSC as Optimized Lead Compounds. Any FTE Funding Commitment, any Annual Research Plan may be amended from time to time by the JSC JRC and approved by the JEC pursuant to Section 2.1.4. Each amendment, modification and update to the Annual Research Plan shall include the resulting changes to the budget, including the number of FTEs to be utilized by ARCHEMIX, and shall be set forth in a written document prepared by, or at the direction of, the JPT and approved by the JSCJEC, shall specifically state that it is an amendment, modification or update to the Annual Research Plan and shall be attached to the minutes of the meeting of the JSC JEC at which such amendment, modification or update was approved by the JSC. Without limiting the nature or frequency of any other amendments, modifications or updates to the Annual Research Plan that may be approved by the JSC, the Annual Research Plan shall be updated at least once prior to the end of each Fiscal Year to describe the research activities to be carried out by each Party during the upcoming Fiscal Year during the Research Program Term in conducting the Research Program pursuant to this Agreementapproved.

Appears in 1 contract

Samples: And License Agreement (Arqule Inc)

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