Function and Powers of the JSC. The Joint Steering Committee shall be responsible for overseeing and managing the Research Program and the conduct of activities under the Research Plan. SpinCo shall, through the JSC, update the Company on its progress under the Research Plan on at least a monthly basis during the Research Term. Without limiting the generality of the foregoing, the JSC shall be responsible for the following: (i) reviewing and serving as a forum for discussing the Research Plan and the Budgeted Amounts, reviewing, revising (as applicable), and recommending for adoption by the Parties the complete Research Plan, and preparing, reviewing and recommending for adoption by the Parties updates and amendments to the Research Plan and the Budgeted Amounts; (ii) reviewing, revising (as applicable), and recommending for adoption by the Parties the final version of Schedule 1 and Schedule 5; (iii) reviewing, revising (as applicable), and approving [***]; (iv) monitoring compliance with the Research Plan, including the accomplishment of key objectives and reviewing actual monthly spending versus the Budgeted Amounts; CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. (v) providing a forum for SpinCo to present to and discuss with the Company the Collaboration Compounds, including Collaboration Compounds that show promise for the Field, and for the Parties to coordinate the Company’s access to Collaboration Compounds and related Information; (vi) selecting and prioritizing Collaboration Compounds for further research and evaluation under the Research Plan, including adopting and amending from time to time the criteria to be used by the JSC for selecting and prioritizing Collaboration Compounds that will be evaluated under the Initial Screening Process; (vii) discussing and determining which Collaboration Compounds constitute Eligible Compounds in accordance with Section 2.2(c), including adopting and amending from time to time the criteria to be used by the JSC in determining whether to select particular Collaboration Compounds as Eligible Compounds; (viii) reviewing and discussing (but not selecting) each Company Selected Compound under consideration by the Company for selection as an Acquired Compound in accordance with Section 3.1; (ix) reviewing and coordinating with respect to members of the Research Team, including reviewing such members’ qualifications; (x) issuing promptly such notices as the JSC is required to provide to one or both Parties pursuant to this Agreement, including notices with respect to the selection of Eligible Compounds for the Eligible Compound Pool, the other Party’s exercise of Picks by each Party and the achievement of Eligible Compound Pool Satisfaction from time to time hereunder; and (xi) taking such other actions or making such other decisions as may be delegated to the JSC pursuant to this Agreement or by mutual written agreement of the Parties after the Effective Date. For clarity, with respect to the adoption of the complete Research Plan, or updates or amendments to the Research Plan, or final Schedule 1 or Schedule 5, such Research Plan (or update or amendment) and schedules shall not be effective unless and until executed by an authorized representative of each Party.
Appears in 2 contracts
Samples: Research Collaboration Agreement (Aptinyx Inc.), Research Collaboration Agreement (Aptinyx Inc.)
Function and Powers of the JSC. The Joint Steering Committee shall be responsible for overseeing and managing the Research Program and the conduct of activities under the Research Plan. SpinCo JSC shall, through in line with the JSC, update terms and conditions set forth in the Company on its progress under the Research Plan on at least a monthly basis during the Research Term. Without limiting the generality of the foregoing, the JSC shall be responsible for the followingAgreement:
(i) define the scope of the research and development activities to be conducted under this Agreement, including by reviewing and serving as a forum for discussing approving the Research Plan and the Budgeted Amounts, reviewing, revising (as applicable), and recommending for adoption by the Parties the complete Research initial Development Plan, and preparing, reviewing and recommending for adoption by the Parties updates and amendments each update to the Research Development Plan and associated Budget, and review progress against the Budgeted Amountsgoals in such Development Plan;
(ii) reviewing, revising (as applicable), discuss and recommending for adoption by agree upon the Parties allocation of the final version of Schedule 1 and Schedule 5Budget to activities under the Development Plan;
(iii) reviewing, revising (as applicable), discuss and approving [***]comment on updates provided by Institute in relation to the Autologous Programs;
(iv) monitoring compliance with review and discuss proposals for new Indications for Licensed Products to be included within the Research activities under the Development Plan, including the accomplishment of key objectives and reviewing actual monthly spending versus the Budgeted Amounts; CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.;
(v) providing a forum for SpinCo to present to review and discuss with the Company the Collaboration Compounds, including Collaboration Compounds that show promise potential Targets for the Field, and for the Parties to coordinate the Company’s access to Collaboration Compounds and related Informationconsideration as potential New Research Programs;
(vi) selecting consider, discuss and prioritizing Collaboration Compounds make recommendations with respect to proposals for further research and evaluation under the New Research Plan, including adopting and amending from time to time the criteria to be used by the JSC for selecting and prioritizing Collaboration Compounds that will be evaluated under the Initial Screening ProcessPrograms;
(vii) discussing and determining which Collaboration Compounds constitute Eligible Compounds in accordance with Section 2.2(c), including adopting and amending from time to time the criteria to be used by the JSC in determining whether to select particular Collaboration Compounds as Eligible Compounds;discuss Atara’s regulatory strategy for IND filing for CTL Products; 9746176_1.docx
(viii) reviewing validate and discussing (but not selecting) each Company Selected Compound under consideration by back up the Company for selection as an Acquired Compound in accordance with Section 3.1intellectual property strategy;
(ix) reviewing review and coordinating with respect to members of the Research Teamtrack publications and proposed publications, including reviewing such members’ qualificationsand coordinate review and comments on proposed publications by each Party;
(x) issuing promptly establish subcommittees, as appropriate, and support the operation of such notices as the JSC is required to provide to one or both Parties pursuant to this Agreementsubcommittees, including notices with respect by seeking to resolve disputed matters that may arise at the selection subcommittees;
(xi) assume a general role of Eligible Compounds for leadership in the Eligible Compound Pool, the other Party’s exercise of Picks by each Party and the achievement of Eligible Compound Pool Satisfaction from time to time hereundercollaboration; and
(xixii) taking such other actions or making such other decisions as may be delegated perform any and all tasks and responsibilities that are expressly attributed to the JSC pursuant to under this Agreement. Notwithstanding the foregoing roles and responsibilities, unless expressly set forth in this Agreement or by mutual written agreement of the Parties after License Agreement, the Effective Date. For clarity, JSC shall serve solely as a forum for information exchange with respect to any matters that relate to (i) regulatory matters, including the adoption regulatory strategy and filings for Regulatory Approvals in the Territory, (ii) commercialization of CTL Products (whether or not arising out of this Agreement), (iii) changes to the Budget for activities under the Development Plan with respect to Allogeneic CTL Programs or New Research Programs, and (iv) subject to Article 13 of the complete Research PlanLicense Agreement, or updates or amendments to the Research Planintellectual property strategy, or final Schedule 1 or Schedule 5including prosecution, such Research Plan (or update or amendment) maintenance and schedules shall not be effective unless and until executed by an authorized representative of each Partyenforcement activities.
Appears in 1 contract
Samples: Research and Development Collaboration Agreement (Atara Biotherapeutics, Inc.)
Function and Powers of the JSC. The Joint Steering Committee shall be responsible for overseeing and managing the Research Program and the conduct of activities under the Research Plan. SpinCo JSC shall, through in line with the JSC, update terms and conditions set forth in the Company on its progress under the Research Plan on at least a monthly basis during the Research Term. Without limiting the generality of the foregoing, the JSC shall be responsible for the followingAgreement:
(i) define the scope of the research and development activities to be conducted under this Agreement, including by reviewing and serving as a forum for discussing approving the Research Plan and the Budgeted Amounts, reviewing, revising (as applicable), and recommending for adoption by the Parties the complete Research initial Development Plan, and preparing, reviewing and recommending for adoption by the Parties updates and amendments each update to the Research Development Plan and associated Budget, and review progress against the Budgeted Amounts;goals in such Development Plan;
(ii) reviewingdiscuss and agree upon the allocation of the Budget, revising (as applicable)including the Minimum Research Contribution, and recommending for adoption by to activities under the Parties the final version of Schedule 1 and Schedule 5Development Plan;
(iii) reviewing, revising (as applicable), discuss and approving [***]comment on updates provided by Institute in relation to the Autologous Programs;
(iv) monitoring compliance with review and discuss proposals for new Indications for Licensed Products to be included within the Research activities under the Development Plan, including the accomplishment of key objectives and reviewing actual monthly spending versus the Budgeted Amounts; CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.;
(v) providing a forum for SpinCo to present to review and discuss with the Company the Collaboration Compounds, including Collaboration Compounds that show promise potential Targets for the Field, and for the Parties to coordinate the Company’s access to Collaboration Compounds and related Informationconsideration as potential New Research Programs;
(vi) selecting consider, discuss and prioritizing Collaboration Compounds make recommendations with respect to proposals for further research and evaluation under the New Research Plan, including adopting and amending from time to time the criteria to be used by the JSC for selecting and prioritizing Collaboration Compounds that will be evaluated under the Initial Screening ProcessPrograms;
(vii) discussing and determining which Collaboration Compounds constitute Eligible Compounds in accordance with Section 2.2(c), including adopting and amending from time to time the criteria to be used by the JSC in determining whether to select particular Collaboration Compounds as Eligible Compounds;discuss Atara’s regulatory strategy for IND filing for CTL Products ;
(viii) reviewing validate and discussing (but not selecting) each Company Selected Compound under consideration by back up the Company for selection as an Acquired Compound in accordance with Section 3.1;intellectual property strategy;
(ix) reviewing review and coordinating with respect to members of the Research Teamtrack publications and proposed publications, including reviewing such members’ qualificationsand coordinate review and comments on proposed publications by each Party;
(x) issuing promptly establish subcommittees, as appropriate, and support the operation of such notices as the JSC is required to provide to one or both Parties pursuant to this Agreementsubcommittees, including notices with respect by seeking to resolve disputed matters that may arise at the selection of Eligible Compounds for the Eligible Compound Pool, the other Party’s exercise of Picks by each Party and the achievement of Eligible Compound Pool Satisfaction from time to time hereunder; andsubcommittees;
(xi) taking such other actions or making such other decisions as may be delegated assume a general role of leadership in the collaboration;
(xii) perform any and all tasks and responsibilities that are expressly attributed to the JSC pursuant to under this Agreement. Notwithstanding the foregoing roles and responsibilities, unless expressly set forth in this Agreement or by mutual written agreement of the Parties after License Agreement, the Effective Date. For clarity, JSC shall serve solely as a forum for information exchange with respect to any matters that relate to (i) regulatory matters, including the adoption regulatory strategy and filings for Regulatory Approvals in the Territory, (ii) commercialization of CTL Products (whether or not arising out of this Agreement), (iii) changes to the Minimum Research Contribution or the Budget for activities under the Development Plan with respect to Allogeneic CTL Programs or New Research Programs, and (iv) subject to Article 13 of the complete Research PlanLicense Agreement, or updates or amendments to the Research Planintellectual property strategy, or final Schedule 1 or Schedule 5including prosecution, such Research Plan (or update or amendment) maintenance and schedules shall not be effective unless and until executed by an authorized representative of each Partyenforcement activities.
Appears in 1 contract
Samples: Research and Development Collaboration Agreement (Atara Biotherapeutics, Inc.)
Function and Powers of the JSC. The Joint Steering Committee shall be responsible for overseeing and managing the Research Program and the conduct of activities under the Research Plan. SpinCo JSC shall, through in line with the JSC, update terms and conditions set forth in the Company on its progress under the Research Plan on at least a monthly basis during the Research Term. Without limiting the generality of the foregoing, the JSC shall be responsible for the followingAgreement:
(i) define the scope of the research and development activities to be conducted under this Agreement, including by reviewing and serving as a forum for discussing approving the Research Plan and the Budgeted Amounts, reviewing, revising (as applicable), and recommending for adoption by the Parties the complete Research initial Development Plan, and preparing, reviewing and recommending for adoption by the Parties updates and amendments each update to the Research Development Plan and associated Budget, and review progress against the Budgeted Amountsgoals in such Development Plan;
(ii) reviewing, revising (as applicable), discuss and recommending for adoption by agree upon the Parties allocation of the final version of Schedule 1 and Schedule 5Budget to activities under the Development Plan;
(iii) reviewing, revising (as applicable), discuss and approving [***]comment on updates provided by Institute in relation to the Autologous Programs;
(iv) monitoring compliance with review and discuss proposals for new Indications for Licensed Products to be included within the Research activities under the Development Plan, including the accomplishment of key objectives and reviewing actual monthly spending versus the Budgeted Amounts; CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.;
(v) providing a forum for SpinCo to present to review and discuss with the Company the Collaboration Compounds, including Collaboration Compounds that show promise potential Targets for the Field, and for the Parties to coordinate the Company’s access to Collaboration Compounds and related Informationconsideration as potential New Research Programs;
(vi) selecting consider, discuss and prioritizing Collaboration Compounds make recommendations with respect to proposals for further research and evaluation under the New Research Plan, including adopting and amending from time to time the criteria to be used by the JSC for selecting and prioritizing Collaboration Compounds that will be evaluated under the Initial Screening ProcessPrograms;
(vii) discussing and determining which Collaboration Compounds constitute Eligible Compounds in accordance with Section 2.2(c), including adopting and amending from time to time the criteria to be used by the JSC in determining whether to select particular Collaboration Compounds as Eligible Compoundsdiscuss Atara’s regulatory strategy for IND filing for CTL Products;
(viii) reviewing validate and discussing (but not selecting) each Company Selected Compound under consideration by back up the Company for selection as an Acquired Compound in accordance with Section 3.1intellectual property strategy;
(ix) reviewing review and coordinating with respect to members of the Research Teamtrack publications and proposed publications, including reviewing such members’ qualificationsand coordinate review and comments on proposed publications by each Party;
(x) issuing promptly establish subcommittees, as appropriate, and support the operation of such notices as the JSC is required to provide to one or both Parties pursuant to this Agreementsubcommittees, including notices with respect by seeking to resolve disputed matters that may arise at the selection subcommittees;
(xi) assume a general role of Eligible Compounds for leadership in the Eligible Compound Pool, the other Party’s exercise of Picks by each Party and the achievement of Eligible Compound Pool Satisfaction from time to time hereundercollaboration; and
(xixii) taking such other actions or making such other decisions as may be delegated perform any and all tasks and responsibilities that are expressly attributed to the JSC pursuant to under this Agreement. Notwithstanding the foregoing roles and responsibilities, unless expressly set forth in this Agreement or by mutual written agreement of the Parties after License Agreement, the Effective Date. For clarity, JSC shall serve solely as a forum for information exchange with respect to any matters that relate to (i) regulatory matters, including the adoption regulatory strategy and filings for Regulatory Approvals in the Territory, (ii) commercialization of CTL Products (whether or not arising out of this Agreement), (iii) changes to the Budget for activities under the Development Plan with respect to Allogeneic CTL Programs or New Research Programs, and (iv) subject to Article 13 of the complete Research PlanLicense Agreement, or updates or amendments to the Research Planintellectual property strategy, or final Schedule 1 or Schedule 5including prosecution, such Research Plan (or update or amendment) maintenance and schedules shall not be effective unless and until executed by an authorized representative of each Partyenforcement activities.
Appears in 1 contract
Samples: Research and Development Collaboration Agreement (Atara Biotherapeutics, Inc.)
Function and Powers of the JSC. The Joint Steering Committee shall be responsible for overseeing and managing the Research Program and the conduct of activities under the Research Plan. SpinCo JSC shall, through consistent with the JSCterms and conditions set forth in this Agreement, update the Company on its progress under the Research Plan on at least a monthly basis during the Research Term. Without limiting the generality of the foregoing, the JSC shall be responsible for the followingand subject to Section 2.1.5:
(i) reviewing and serving as a forum for discussing coordinate the Research Plan and the Budgeted Amounts, reviewing, revising (as applicable), and recommending for adoption by the Parties the complete Research Plan, and preparing, reviewing and recommending for adoption by the Parties updates and amendments to the Research Plan and the Budgeted AmountsParties’ activities under this Agreement;
(ii) reviewing, revising (as applicable), and recommending decide whether to include any particular Available Target for adoption by the Parties the final version of Schedule 1 and Schedule 5Preclinical Research under this Agreement;
(iii) reviewing, revising (select a Product Directed Against a Collaboration Target as applicable), and approving [***]a clinical candidate for further Development;
(iv) monitoring compliance define each Collaboration Target in accordance with the Section 3.1, and approve (A) each Preclinical Research Plan and Preclinical Research Budget for each Collaboration Target and any amendments thereto, (B) each Development Plan, Development Budget, Commercialization Plan and Commercialization Budget for each Cost Share Product and any amendments thereto, and (C) updates to each such Preclinical Research Plan, including Preclinical Research Budget, Development Plan, Development Budget, Commercialization Plan and Commercialization Budget (in each case other than for the accomplishment of key objectives Preclinical Research Plan and reviewing actual monthly spending versus the Budgeted Amounts; CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “Preclinical Research Budget, only for Cost Share Products) on [***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933] basis or as otherwise agreed upon by the Parties, AS AMENDED.and review progress against the goals in such plans and budgets;
(v) providing oversee the implementation of each Preclinical Research Plan for each Collaboration Target and Product and review and serve as a forum for SpinCo to present to and discuss with discussion of the Company results of the Collaboration Compounds, including Collaboration Compounds that show promise for the Field, and for the Parties to coordinate the Company’s access to Collaboration Compounds and related Informationactivities being carried out thereunder;
(vi) selecting serve as an information-sharing forum for Preclinical Research, Development (including regulatory strategy for IND filing) and prioritizing Collaboration Compounds Commercialization for further research and evaluation under the Research Plan, including adopting and amending from time to time the criteria to be used by the JSC for selecting and prioritizing Collaboration Compounds that will be evaluated under the Initial Screening Processeach Product;
(vii) discussing with respect to any Product that is not a Cost Share Product, review and determining which Collaboration Compounds constitute Eligible Compounds in accordance comment on any material strategy changes with Section 2.2(c), including adopting and amending from time respect to time the criteria to be used by the JSC in determining whether to select particular Collaboration Compounds as Eligible Compoundsany Development Plan or Commercialization Plan;
(viii) reviewing and discussing (but not selectingestablish subcommittees, as appropriate, as described more fully in Section 2.1.3(d) each Company Selected Compound under consideration by the Company for selection as an Acquired Compound in accordance with Section 3.1below;
(ix) reviewing direct and coordinating with respect to members of the Research Team, including reviewing such members’ qualificationsoversee any subcommittee;
(x) issuing promptly such notices as the JSC is required to provide to one or both Parties pursuant to this Agreement, including notices with respect discuss estimated sales forecasts for Cost Share Products to the selection of Eligible Compounds extent Astellas has generated any such estimated forecasts for internal use;
(xi) resolve disputed matters that may arise at the Eligible Compound Pool, the other Party’s exercise of Picks by each Party and the achievement of Eligible Compound Pool Satisfaction from time to time hereundersubcommittees; and
(xixii) taking such other actions or making such other decisions as may be delegated perform any and all tasks and responsibilities that are expressly attributed to the JSC pursuant to under this Agreement or by mutual written agreement of the Parties after the Effective Date. For clarity, with respect to the adoption of the complete Research Plan, or updates or amendments to the Research Plan, or final Schedule 1 or Schedule 5, such Research Plan (or update or amendment) and schedules shall not be effective unless and until executed by an authorized representative of each PartyAgreement.
Appears in 1 contract
Samples: Collaboration and License Agreement (CytomX Therapeutics, Inc.)