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
Samples: Collaborative Research and License Agreement (Archemix Corp.), Collaborative Research and License Agreement (Nitromed Inc)
Research Plan. The initial Annual JRC shall create a Research Plan and budget, which describes describing activities for each Holding Target that is reasonably designed to achieve the research activities to be carried out by each Party during the first Contract Year objectives 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 is consistent with the other terms of this Agreement. Without limiting the generality of the foregoing, the objectives of each Annual A Research Plan summary is attached hereto as Schedule C, which summary serves as baseline guidance on a per Program Target basis. Deviations from the summary attached hereto as Schedule C shall include, be made on a Program Target-by-Program Target basis 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 determined by the JPT pursuant to Section 2.2.4 or by the JSC pursuant to 2.1.4JRC. Each amendment, modification and update to of 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 Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. by, or at the direction of, the JPT JRC and approved by the JSCJRC, and 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 JRC at which such amendment, modification or update was approved by the JSCJRC. Without limiting the nature or frequency of any other amendments, modifications or updates to of the Research Plan that may be approved by the JSCJRC, the Annual Research Plan shall be updated at least once prior to the end of each Contract Year Calendar Quarter to describe the research activities to be carried out by each Party during the applicable Contract Year next two (2) Calendar Quarters during the Research Program Term in conducting the Research Program pursuant Program. Anything contained in this Agreement to this Agreementthe contrary notwithstanding, (i) ImmunoGen shall invoice Novartis for, and Novartis shall fund and ImmunoGen shall provide, a [***] per Calendar Year (appropriately pro-rated for the first and last Calendar Years during the Term) during the Term; and (ii) the Research Plan, as the same may be amended, modified or updated, shall not require (A) ImmunoGen to devote [***] (on an annualized basis) at any given time during the Term to the conjugation of Cytotoxic Compounds to Antibodies selected by Novartis and blinded to ImmunoGen, and (B) ImmunoGen to devote [***] (on an annualized basis) at any given time during the Term to the conduct of the ImmunoGen Activities, in each case without ImmunoGen’s prior written consent, which consent [***]. Prior to the end of each Calendar Quarter during the Term, the JRC shall determine the number of FTEs to be devoted to the conduct of the ImmunoGen Activities in each of the next two (2) following Calendar Quarters (each a “Rolling Forecast”). ImmunoGen shall not be required to devote [***] (on an annualized basis) during the second Calendar Quarter of each Rolling Forecast over the [***] set forth for the second Calendar Quarter of the immediately preceding Rolling Forecast (or, if less, the [***] (on an annualized basis) devoted to the ImmunoGen Activities during the Calendar Quarter immediately preceding the Calendar Quarter in question) without ImmunoGen’s prior written consent, which consent [***]. Notwithstanding the foregoing, ImmunoGen shall not be required to devote [***] (x) [***] (on an annualized basis) during each of the [***] during the Term (appropriately pro-rated for the first Calendar Quarter during the Term), and (y) [***] (on an annualized basis) during the [***] during the Term, in each case without ImmunoGen’s prior written consent, which consent [***].
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
Samples: Strategic Collaboration and License Agreement (Alnylam Pharmaceuticals, Inc.)
Research Plan. The initial Annual JRC shall create a Research Plan describing activities for each Holding Option Target and budget, which describes Research Option Target that is reasonably designed to achieve the research activities to be carried out by each Party during the first Contract Year objectives 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 is consistent with the other terms of this Agreement. Without limiting the generality of the foregoing, the objectives of each Annual An initial Research Plan shall includetemplate is attached hereto as Schedule B, which summary template serves as appropriate baseline guidance on a per Program Target basis. Deviations from time to time during the Research Plan summary attached hereto as Schedule B shall be made on a Program Term, conducting the necessary research activities to identify Lead Compounds or to determine whether Lead Compounds should be nominated to the JSC Target-by-Program Target basis as Optimized Lead Compounds. Any Annual Research Plan may be amended from time to time determined by the JPT pursuant to JRC in accordance with Section 2.2.4 or by the JSC pursuant to 2.1.44.2(c) hereof. Each amendment, modification and update to of 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 JRC and approved by the JSCJRC, and 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 JRC at which such amendment, modification or update was approved by the JSCJRC. Without limiting the nature or frequency of any other Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. amendments, modifications or updates to of the Research Plan that may be approved by the JSCJRC, the Annual Research Plan shall be updated at least once prior to the end of each Contract Year Calendar Quarter to describe the research activities to be carried out by each Party during the applicable Contract Year next two (2) Calendar Quarters during the Research Program Term in conducting the Research Program pursuant Program. Anything contained in this Agreement to this Agreementthe contrary notwithstanding, the Research Plan, as the same may be amended, modified or updated, shall not require ImmunoGen to devote [***] FTEs (on an annualized basis) at any given time during the Term to the conduct of the ImmunoGen Activities, without ImmunoGen’s prior written consent, which consent ImmunoGen may withhold in its sole discretion. Prior to the end of each Calendar Quarter during the Term, the JRC shall determine the number of FTEs to be devoted to the conduct of the ImmunoGen Activities in each of the next two (2) following Calendar Quarters (each a “Rolling Forecast”). ImmunoGen shall not be required to devote more than [***] FTE (on an annualized basis) during the second Calendar Quarter of each Rolling Forecast over the maximum number of FTEs set forth for the second Calendar Quarter of the immediately preceding Rolling Forecast (or, [***], the [***] of FTEs (on an annualized basis) [***] during the [***] the [***] in question) without ImmunoGen’s prior written consent, which consent ImmunoGen may withhold in its sole discretion. Notwithstanding the foregoing, ImmunoGen shall not be required to devote more than (x) [***] FTEs (on an annualized basis) during each of the [***] during the Term (appropriately pro-rated for the first Calendar Quarter during the Term), and (y) [***] FTEs (on an annualized basis) during the [***] during the Term, in each case without ImmunoGen’s prior written consent, which consent ImmunoGen may withhold in its sole discretion.
Appears in 1 contract
Samples: License Agreement (Immunogen Inc)
Research Plan. The initial Annual All 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, under this Agreement shall be prepared by the JPT and submitted to, and approved by, the JSC within [***] days of the Effective Date. For each Contract Year conducted pursuant to a comprehensive written Research plan for Astellas’ fiscal year during the Research Program Term commencing (the “Research Plan”). The Research Plan shall allocate Research responsibilities between the Parties and shall set forth the objectives, activities and criteria for evaluation for such Research, as well as the timeline related thereto. The Research Plan shall also set forth the detailed budget [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the second Contract Year, an Annual Research Plan Securities and budget shall be prepared by or at the direction Exchange Commission pursuant to Rule 406 of the JPT and submitted to the JSC Securities Act of 1933, as amended. for its approval. The JPT shall manage the preparation such Research activities, including a minimum of each Annual Research Plan in a manner designed to obtain JSC approval no later than [**] Cytokinetics FTEs that Astellas shall support annually [*] days prior to (the end of the then-current Contract Year. Each Annual “Cytokinetics 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 ARCHEMIXFTEs”), and (vi) with respect to ARCHEMIX Research Activities, the number of Astellas FTEs estimated to be required to perform such activities; committed by Astellas during the Research Term and outsourced costs (b) shall be consistent with the other terms of this Agreement“Research Budget”). Without limiting the generality of the foregoing, the objectives of each Annual Research Plan shall include, as appropriate from 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 JRC shall prepare updates and amendments, as appropriate, to the JSC as Optimized Lead Compounds. Any Annual then-current Research Plan may be amended from time to time by (including the JPT pursuant to Section 2.2.4 or by Research Budget). In any event, the JSC pursuant to 2.1.4. Each amendment, modification and update to the Annual Research Plan shall include for the resulting changes to the budget, including the number of FTEs to be utilized by ARCHEMIX, forthcoming Astellas’ fiscal year shall be set forth in a written document prepared byapproved by [*] of the preceding year, or at the direction ofprovided that by [*] of each calendar year, the JPT JRC shall agree upon a proposed budget for the following Astellas fiscal year with respect to costs other than for the Cytokinetics Research FTEs, and approved Astellas shall use good faith efforts to obtain internal approval for such proposed budget to become effective by [*]. The JRC shall have the JSC, shall specifically state that it is an amendment, modification or update right to the Annual Research Plan approve updates 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 amendments to the Research Plan (including the Research Budget), provided that may be no amendment to the Research Plan (including the Research Budget) shall decrease the number of Cytokinetics Research FTEs supported by Astellas without Cytokinetics’ consent. Once approved by the JSCJRC, the Annual such revised Research Plan shall be updated at least once replace the prior to Research Plan. If the end terms 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 Plan contradict, or create inconsistencies or ambiguities with, the Research Program pursuant to terms of this Agreement, then the terms of this Agreement shall govern.
Appears in 1 contract
Samples: License and Collaboration Agreement (Cytokinetics Inc)
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 with respect to Research Antigens (other criteria than CuraGen Exclusive Antigens), other than those specified in Exhibit C as being the responsibility 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 Portions of this Exhibit were omitted and have been filed separately with the JPT will utilize Secretary of the Commission pursuant to the Company's application requesting confidential Investment under Rule 406 of the Securities Act. therefor are approved by the JMC prior to incurring any such expense. Notwithstanding anything to the contrary in this Agreement, all activities with respect to Research Antigens that are CuraGen Exclusive Antigens, other than the generation and biochemical characterization of Antibodies as described and allocated to ABX in Exhibit C, shall be the sole and exclusive responsibility of CuraGen, at its sole cost and 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, the preceding right shall not apply to ABX in the case of Research Antigens that are CuraGen Exclusive Antigens, and provided further that prior to commencing such additional preclinical research with respect to Research Antigens that are not CuraGen Exclusive Antigens, 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; provided, however, that CuraGen shall transfer to ABX all information and materials available to CuraGen that are useful in the conduct of all assays conducted by or on behalf of CuraGen in connection with the Research Program. ABX shall reimburse CuraGen for all reasonable out-of-pocket expenses incurred in effecting such transfer. CuraGen grants to ABX the nonexclusive, worldwide license (without the right to grant sublicenses) to practice and use all such assays both (a) for use in the Research Program, and (b) for research purposes (unrelated to the Research Program or CuraGen) related to the research and development of antigens and/or antibodies. ABX shall make the antibody generation/isolation technologies of Immgenics, Inc. available for use by ABX in the performance of its obligations under Exhibit C. 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. All Research activities under this Agreement shall be conducted pursuant to a comprehensive written Research plan for Astellas’ fiscal year during the Research Term (the “Research Plan”). The initial Annual Research Plan shall allocate Research responsibilities between the Parties and budgetshall set forth the objectives, which describes activities and criteria for evaluation for such Research, as well as the research activities to be carried out by each Party timeline related thereto. The Research Plan shall also set forth the detailed budget for such Research activities, including [*] Cytokinetics FTEs that Astellas shall support annually during the first Contract Year initial [*] of the Research Program Term, shall be prepared by Term (the JPT and submitted to, and approved by“Cytokinetics Research FTEs”), the JSC within [***] days number of Astellas FTEs committed by Astellas during the Research Term and outsourced costs (the “Research Budget”). As of the Effective Date. For each Contract Year during , the Parties have agreed upon an initial Research Plan (including 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 Budget) pertaining 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 conducted by the Annual Research Plan with reasonable specificityParties during the first [*] after the Effective Date, (ii) the research plans and protocols attached to be employed to complete each stage of the Research Programthis Agreement as Exhibit G, (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 which plan and budget for such activities (including Third Party expenses will be deemed to be incurred for outsourced studies managed have been approved by ARCHEMIX)the JRC. Thereafter, 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 JRC shall prepare updates and amendments, as appropriate, to the JSC as Optimized Lead Compounds. Any Annual then-current Research Plan may be amended from time to time by (including the JPT pursuant to Section 2.2.4 or by Research Budget). In any event, the JSC pursuant to 2.1.4. Each amendment, modification and update to the Annual Research Plan shall include for the resulting changes to the budget, including the number of FTEs to be utilized by ARCHEMIX, forthcoming Astellas’ fiscal year shall be set forth in a written document prepared byapproved by [*] of the preceding year, or at the direction ofprovided that by [*] of each calendar year, the JPT JRC shall agree upon a proposed budget for the following Astellas fiscal year with respect to costs other than for the Cytokinetics Research FTEs, and approved Astellas shall use good faith efforts to obtain internal approval for such proposed budget to become effective by [*]. The JRC shall have the JSC, shall specifically state that it is an amendment, modification or update right to the Annual Research Plan approve updates 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 amendments to the Research Plan (including the Research Budget), provided that may be no amendment to the Research Plan (including the Research Budget) shall decrease the number of Cytokinetics Research FTEs supported by Astellas without Cytokinetics’ consent. Once approved by the JSCJRC, the Annual such revised Research Plan shall be updated at least once replace the prior to Research Plan. If the end terms 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 Plan contradict, or create inconsistencies or ambiguities with, the Research Program pursuant to terms of this Agreement, then the terms of this Agreement shall govern.
Appears in 1 contract
Samples: License and Collaboration Agreement (Cytokinetics Inc)
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.
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Research Plan. The initial Annual JRC shall create a Research Plan and budget, which describes describing activities for each Holding Target that is reasonably designed to achieve the research activities to be carried out by each Party during the first Contract Year objectives 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 is consistent with the other terms of this Agreement. Without limiting the generality of the foregoing, the objectives of each Annual A Research Plan summary is attached hereto as Schedule C, which summary serves as baseline guidance on a per Program Target basis. Deviations from the summary attached hereto as Schedule C shall include, be made on a Program Target-by-Program Target basis 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 determined by the JPT pursuant to Section 2.2.4 or by the JSC pursuant to 2.1.4JRC. Each amendment, modification and update to of 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 JRC and approved by the JSCJRC, and 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 JRC at which such amendment, modification or update was approved by the JSCJRC. Without limiting the nature or frequency of any other amendments, modifications or Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. updates to of the Research Plan that may be approved by the JSCJRC, the Annual Research Plan shall be updated at least once prior to the end of each Contract Year Calendar Quarter to describe the research activities to be carried out by each Party during the applicable Contract Year next two (2) Calendar Quarters during the Research Program Term in conducting the Research Program pursuant Program. Anything contained in this Agreement to this Agreementthe contrary notwithstanding, (i) ImmunoGen shall invoice Novartis for, and Novartis shall fund and ImmunoGen shall provide, a [***] FTEs per Calendar Year (appropriately pro-rated for the first and last Calendar Years during the Term) during the Term; and (ii) the Research Plan, as the same may be amended, modified or updated, shall not require (A) ImmunoGen to devote [***] FTEs (on an annualized basis) at any given time during the Term to the conjugation of Cytotoxic Compounds to Antibodies selected by Novartis and blinded to ImmunoGen, and (B) ImmunoGen to devote [***] FTEs (on an annualized basis) at any given time during the Term to the conduct of the ImmunoGen Activities, in each case without ImmunoGen’s prior written consent, which consent [***]. Prior to the end of each Calendar Quarter during the Term, the JRC shall determine the number of FTEs to be devoted to the conduct of the ImmunoGen Activities in each of the next two (2) following Calendar Quarters (each a “Rolling Forecast”). ImmunoGen shall not be required to devote [***] FTEs (on an annualized basis) during the second Calendar Quarter of each Rolling Forecast over the [***] FTEs set forth for the second Calendar Quarter of the immediately preceding Rolling Forecast (or, if less, the [***] FTEs (on an annualized basis) devoted to the ImmunoGen Activities during the Calendar Quarter immediately preceding the Calendar Quarter in question) without ImmunoGen’s prior written consent, which consent [***]. Notwithstanding the foregoing, ImmunoGen shall not be required to devote [***] (x) [***] FTEs (on an annualized basis) during each of the [***] Calendar Quarters during the Term (appropriately pro-rated for the first Calendar Quarter during the Term), and (y) [***] FTEs (on an annualized basis) during the [***] Calendar Quarter during the Term, in each case without ImmunoGen’s prior written consent, which consent [***].
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Research Plan. The initial Annual JRC shall create a Research Plan describing activities for each Holding Option Target and budget, which describes Research Option Target that is reasonably designed to achieve the research activities to be carried out by each Party during the first Contract Year objectives 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 is consistent with the other terms of this Agreement. Without limiting the generality of the foregoing, the objectives of each Annual An initial Research Plan shall includetemplate is attached hereto as Schedule B, which summary template serves as appropriate baseline guidance on a per Program Target basis. Deviations from time to time during the Research Plan summary attached hereto as Schedule B shall be made on a Program Term, conducting the necessary research activities to identify Lead Compounds or to determine whether Lead Compounds should be nominated to the JSC Target-by-Program Target basis as Optimized Lead Compounds. Any Annual Research Plan may be amended from time to time determined by the JPT pursuant to JRC in accordance with Section 2.2.4 or by the JSC pursuant to 2.1.44.2(c) hereof. Each amendment, modification and update to of 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 JRC and approved by the JSCJRC, and 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 JRC at which such amendment, modification or update was approved by the JSCJRC. Without limiting the nature or frequency of any other amendments, modifications or updates to of the Research Plan that may be approved by the JSCJRC, the Annual Research Plan shall be updated at least once prior to the end of each Contract Year Calendar Quarter to describe the research activities to be carried out by each Party during the applicable Contract Year next two (2) Calendar Quarters during the Research Program Term in conducting the Research Program Program. Anything contained in this Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to this Agreementthe Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Agreement to the contrary notwithstanding, the Research Plan, as the same may be amended, modified or updated, shall not require ImmunoGen to devote [***] (on an annualized basis) at any given time during the Term to the conduct of the ImmunoGen Activities, without ImmunoGen’s prior written consent, which consent ImmunoGen may withhold in its sole discretion. Prior to the end of each Calendar Quarter during the Term, the JRC shall determine the number of FTEs to be devoted to the conduct of the ImmunoGen Activities in each of the next two (2) following Calendar Quarters (each a “Rolling Forecast”). ImmunoGen shall not be required to devote more than [***] (on an annualized basis) during the second Calendar Quarter of each Rolling Forecast over the maximum number of FTEs set forth for the second Calendar Quarter of the immediately preceding Rolling Forecast [***] without ImmunoGen’s prior written consent, which consent ImmunoGen may withhold in its sole discretion. Notwithstanding the foregoing, ImmunoGen shall not be required to devote more than (x) [***] FTEs (on an annualized basis) during each of the [***] during the Term (appropriately pro-rated for the first Calendar Quarter during the Term), and (y) [***] FTEs (on an annualized basis) during the [***] during the Term, in each case without ImmunoGen’s prior written consent, which consent ImmunoGen may withhold in its sole discretion.
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