Research Plan. The initial Annual Research Plan and budget, which describes the research activities to be carried out by each Party during the first Contract Year of the Research Program Term, shall be prepared by the JPT and submitted to, and approved by, the JSC within [***] days of the Effective Date. For each Contract Year during the Research Program Term commencing with the second Contract 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 Contract Year. Each Annual Research Plan shall: (a) set forth (i) the research objectives and activities to be performed 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 of the Research Program, (iii) changes to the OLSC and any other criteria that the JPT will utilize to evaluate the results of the Research Program to nominate Optimized Lead Compounds, (iv) the Party that shall be responsible for performing such activities, (v) a timeline and budget for such activities (including Third Party expenses to be incurred for outsourced studies managed by ARCHEMIX), 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 Lead Compounds or to determine whether 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 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, 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 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 Contract Year to describe the research activities to be carried out by each Party during the applicable Contract Year during the Research Program Term in conducting the Research Program pursuant to this Agreement.
Appears in 2 contracts
Sources: Collaborative Research and License Agreement (Nitromed Inc), Collaborative Research and License Agreement (Archemix Corp.)
Research Plan. In the event that research activities are to be undertaken within the scope of Section 4.1, the JPT shall prepare and the JRC shall agree a comprehensive research plan for the proposed research activities setting out the research program of activities the Parties shall conduct within the budget agreed in Section 4.1 (“Research Plan”). The initial Annual Research Plan and budgetshall include, which describes among other things, (i) a detailed description of the research activities to be carried out undertaken, estimated timelines, decision points and relevant decision criteria; (ii) allocation of responsibilities between the Parties for the various activities to be undertaken under the Research Plan taking into consideration all relevant factors (including the strategic objectives and capabilities of each Party), including estimated timelines; (iii) identification of the lead party with responsibility for the Research Plan; (iv) a budget for the Costs and expenses relating to the activities in the Research Plan (“Research Budget”); and (v) the allocation of each Party’s funding obligations within the Research Budget for all such activities; all based on what can reasonably be foreseen and planned at the time of preparation of the Research Plan.
4.2.1 Any matters under a Research Plan which the Parties through the JRC agree to undertake and which are not explicitly covered by this Agreement shall be overseen by the JRC.
4.2.2 Each Party shall use Diligent Efforts to undertake activities allocated to it under a Research Plan. Each Party shall comply with Applicable Laws applicable to the conduct and documentation of its activities under a Research Plan. Each Party shall, in performing such activities assign responsibilities to those portions of its organization that have the appropriate resources, expertise and responsibility for such obligations.
4.2.3 Each Party shall maintain records of research activities undertaken in accordance with this Article 4 in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party thereunder. All laboratory notebooks shall be maintained for no less than the term of any Patent issuing therefrom. All other records shall be maintained by each Party during the first Contract Year course of the Research Program Term, shall be prepared by the JPT such research activities and submitted to, and approved by, the JSC within for [***] days thereafter. All such records of a Party shall be considered such Party’s Confidential Information. Each Party shall keep the Effective DateJRC fully informed regarding the progress and results of research activities conducted under this Article 4, and shall provide to the other Party’s representatives on the JRC regular written summary update reports at each JRC meeting. For each Contract Year during Each Party will promptly respond to the Research Program Term commencing other Party’s reasonable questions regarding any such reports, and shall provide updates on research activities from time-to-time as such other Party may reasonably request. Neither Party is required to generate additional data or prepare additional reports to comply with the second Contract Yearforegoing obligations.. All such reports, an Annual Research Plan information and budget data provided by a Party shall be prepared by or considered the providing Party’s Confidential Information.
4.2.4 In the event that a Party elects in writing not to participate in a particular research program jointly, and the other Party elects to conduct such research at its sole discretion and expense, the direction of the JPT and submitted Party conducting such research shall provide to the JSC for its approval. The JPT shall manage the preparation of each Annual Research Plan in JRC a manner designed to obtain JSC approval no later than [***] days prior to the end of the then-current Contract Year. Each Annual Research Plan shall: (a) set forth (i) the research objectives and activities to be performed 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 copy of the Research ProgramPlan describing such research that such Party intends to conduct and such Party shall keep the other Party informed of its progress, (iii) changes including an examination of experimental results against such Research Plan through the JRC.
4.2.5 In the event that a Party, or the Parties jointly, wish to carry out research in relation to a variant, derivative or otherwise modified anti-CD3 Effector, the OLSC and any other criteria that the JPT will utilize to evaluate the results of the Parties shall discuss in good faith a Research Program to nominate Optimized Lead Compounds, (iv) the Party that shall be responsible for performing such activities, (v) a timeline and budget Plan for such activities (including Third Party expenses to be incurred for outsourced studies managed by ARCHEMIX), 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 Lead Compounds or to determine whether 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 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, 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 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 Contract Year to describe the research activities to be carried out by each Party during the applicable Contract Year during the Research Program Term in conducting the Research Program pursuant to this Agreementproposed research.
Appears in 2 contracts
Sources: License and Collaboration Agreement (Immunocore LTD), License and Collaboration Agreement (Immunocore LTD)
Research Plan. The initial Annual Research Plan and budget, which describes During the research activities to be carried out by each Party during the first Contract Year of the Research Program Term, shall be prepared by the JPT and submitted to, and approved by, the JSC within [***] days of the Effective Date. For each Contract Year during the Research Program Term commencing with the second Contract 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 Contract Year. Each Annual Research Plan shall: (a) set forth (i) the research objectives and activities to be performed 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 term of the Research Program, (iii) each party shall use its commercially reasonable efforts to perform its obligations set forth in Exhibit C within the time schedules contemplated therein. The JMC may recommend changes to the OLSC allocation of responsibilities set forth in Exhibit C, from time to time; provided, however, that such changes shall only be effective if in a written amendment duly executed by both parties. Other than the activities specified in Exhibit C as being the responsibility of one party or another, the JMC shall allocate the responsibility for each such activity between the parties, taking into account the skills of each party, in an effort to divide the resources and internal costs reasonably required to be dedicated by each party to the conduct of such activities [___________________]. In the event that any activities other criteria than those specified in Exhibit C as being the responsibility 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 Investment under Rule 406 of the Securities Act. of one party or another require any payments to a Third Party for goods or services (e.g., specific animal models), such payments shall be shared [_________________________], provided that all such goods and services and payments therefor are approved by the JPT will utilize JMC prior to incurring any such expense. With respect to each Research Antigen, during the term of the Research Program, each party may conduct, in its sole discretion, such additional preclinical research in the Research Field as such party reasonably desires to evaluate its interest in such Research Antigen, provided that, prior to commencing such additional preclinical research, such party shall give prior written notice to the other party of the nature and scope of such additional preclinical research regarding such Research Antigen and shall provide the other party with all results of such research, which research shall be deemed to have been part of the Research Program. Each party shall provide the personnel, materials, equipment and other resources required to conduct its obligations hereunder. Each party shall perform its obligations hereunder in accordance with high scientific and professional standards, and in compliance in all material respects with the requirements of applicable laws and regulations. Each party shall provide reasonable assistance required by the other party in connection with the performance of the Research Program. Each party shall have the right, at reasonable times during normal business hours and upon reasonable notice, to visit the facilities of the other party where the other party is conducting its obligations under the Research Program to nominate Optimized Lead Compounds, (iv) the Party that shall be responsible for performing observe such activities, (v) a timeline and budget for such activities (including Third Party expenses to be incurred for outsourced studies managed by ARCHEMIX), 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 Lead Compounds or to determine whether 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 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, 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 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 Contract Year to describe the research activities to be carried out by each Party during the applicable Contract Year during the Research Program Term in conducting the Research Program pursuant to this Agreement.
Appears in 1 contract
Research Plan. The initial Annual Research Plan and budget, which describes the research activities to Program will be carried out in accordance with a written research plan, including without limitation the Budget (as defined below), which research plan shall be mutually agreed upon by each Party during the first Contract Year Parties (the “Research Plan”). The initial outline of the Research Program Term, shall be prepared Plan agreed to by the JPT Parties as of the Restatement Date is hereby incorporated into this Agreement by reference and submitted tois made a part of this Agreement; provided, and approved by, the JSC within [***] days of the Effective Restatement Date, the Parties will complete and agree in writing on an initial Research Plan, including without limitation an initial Budget, which is hereby incorporated into this Agreement by reference and is made a part of this Agreement. For each Contract Year during The purpose of the Research Program Term commencing Plan is to detail the responsibilities and activities of Isis and Alnylam with respect to carrying out the second Contract Year, an Annual Research Program. The Research Plan and budget shall be prepared by or at the direction will include a description 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 Contract Year. Each Annual Research Plan shall: (a) set forth (i) the research objectives and specific activities to be performed 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 Parties in support of the Research Program, (iii) changes to the OLSC allocation of Isis FTEs and any other criteria that the JPT will utilize to evaluate the results of the Research Program to nominate Optimized Lead Compounds, (iv) the Party that shall be responsible for performing such activities, (v) a timeline and budget for such activities (including Third Party expenses to be incurred for outsourced studies managed by ARCHEMIX), and (vi) with respect to ARCHEMIX Research Activities, the number of Alnylam FTEs estimated to be required to perform such activities; , projected timelines for completion of such activities, and an applicable budget (b) shall the “Budget”). The Budget for the Research Program must be consistent with mutually agreed by the other terms Parties and will be at least $3,000,000 per year during the Research Term, including without limitation budgeted costs of this AgreementIsis FTEs and Alnylam FTEs, and external costs. Without limiting the generality Beginning in 2010, at least once during September of each year of the foregoingResearch Term, the objectives of each Annual RMC will review the Research Plan shall includeand will amend the Research Plan, as appropriate may be necessary, from time to time during time. In addition, each Calendar Quarter the RMC will review the progress of the work under the Research Program TermPlan, conducting including spending against the necessary research activities to identify Lead Compounds or to determine whether Lead Compounds should be nominated Budget, and recommend adjustments to the JSC Budget as Optimized Lead Compoundsnecessary to support the Research Plan. Any Annual The Research Plan, including without limitation any Budget, may only be amended with the written approval of the RMC. If the activities contemplated by the Research Plan may be amended from at any time to time by the JPT pursuant to Section 2.2.4 or by the JSC pursuant to 2.1.4. Each amendment, modification and update to the Annual Research Plan shall include the resulting changes to the budget, including do not justify the number of Isis FTEs to be utilized by ARCHEMIX, 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 allocated to the Research Plan that may be approved by the JSCProgram, the Annual Parties will work in good faith to mutually agree to modify the scope of the Research Plan or adjust the number of Alnylam funded FTEs and related Budget; provided that the minimum Budget for the Research Plan shall be updated at least once prior as set forth in this Section 4.2(a). For clarity, Alnylam shall not be required to the end of each Contract Year agree to describe the research activities to be carried out by each Party during the applicable Contract Year during the Research Program Term in conducting the Research Program pursuant to this Agreementany Budget which exceeds $3,000,000 per year.
Appears in 1 contract
Sources: Strategic Collaboration and License Agreement (Alnylam Pharmaceuticals, Inc.)