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 ...
Function and Powers of the JSC. The JSC’s responsibilities shall be limited to matters regarding the Programs: (a) coordinating the activities of the Parties, including facilitating communications between the Parties with respect to the Development, Manufacture and Commercialization of Program DARTS and Licensed Products; (b) providing a forum for discussion of the Development, Manufacture, and Commercialization of Licensed Products; (c) reviewing and approving each Research Plan and Global Development Plan and associated Development Budget and any annual or interim updates and proposed amendments thereto; (d) reviewing and discussing Servier’s Commercialization Plan and related activities with respect to Licensed Products throughout the Servier Territory and (if applicable) the MacroGenics Territory, including pre-launch and go-to-market strategies; (e) directing and overseeing the JRDC and any operating subcommittee established by the JSC, on all significant issues that fall within the purview of such committees; (f) attempting to resolve issues presented to it by, and disputes within, the other committees, including the JRDC and any of its subcommittees, in accordance with Section 2.9; and (g) considering and acting upon such other matters as specified in this Agreement.
Function and Powers of the JSC. The JSC shall, consistent with the terms and conditions set forth in this Agreement, and subject to Section 2.1.5:
(i) coordinate the Parties’ activities under this Agreement;
(ii) discuss the overall strategy for the development and regulatory approval of the Products in the Field throughout the Territory;
(iii) facilitate communications and discussion between the Parties with respect to the development, manufacture and commercialization of Products;
(iv) discuss and approve each Development Plan and any proposed amendments or revisions thereto, including timeframes for the Development activities to be carried out thereunder, on an annual basis or as otherwise agreed upon by the Parties;
(v) oversee the implementation of each Development Plan for each Product and review and serve as an information-sharing forum for Development and Commercialization for each Product, including discussion of the results of the activities being carried out thereunder;
(vi) define and coordinate regulatory strategy for each Product;
(vii) establish subcommittees, as appropriate, as described more fully in Section 2.1.3(d) below;
(viii) direct and oversee any subcommittee;
(ix) discuss estimated sales forecasts for Products;
(x) establishing a process for reviewing and commenting on Promotional Materials and training materials and programs for each Product for the Territory;
(xi) designate policies for the Parties’ reporting and recording of Development Costs and other financial terms set forth in this Agreement;
(xii) resolve disputed matters that may arise at the subcommittees; and
(xiii) perform any and all tasks and responsibilities that are expressly attributed to the JSC under this Agreement or that are otherwise agreed by the Parties in writing.
Function and Powers of the JSC. The JSC shall: (a) review and approve the Development Plan and the associated budget and any annual or interim updates and proposed amendments thereto; (b) direct and oversee the JRDC on all significant issues (c) review and approve the recommendations of the JRDC; (d) with respect to each Program, to validate the criteria of success of each Milestone proposed by the JRDC (the “Criteria of Success”) and the achievement of each Milestone, provided that such validation shall be deemed reached if the corresponding Milestone Data meet the corresponding Criteria of Success(e) shall have overall responsibility for the oversight of the performance of the Clinical activities for each Program (f) direct and oversee any operating subcommittee on all significant issues; (g) validate and back-up the intellectual property strategy; (h) resolve disputed matters that may arise at the JRDC and the subcommittees, in accordance with Section 2.10, and (i) assume a general role of leadership in the partnership.
Function and Powers of the JSC. The JSC’s responsibilities shall include:
(i) approving the Research Plan for each Research Program Year;
(ii) approving any changes to the Parties’ Project Leaders;
(iii) facilitating ongoing cooperation and communication between the Parties with respect to the Research Program;
(iv) providing a forum for discussion of the Research Plans, the status of the Research Program, and relevant data;
(v) considering and advising on technical issues and issues of priority that arise in the conduct of the Research Program;
(vi) review and track the exchange and use of Materials (as defined below) pursuant to Section 2.5;
(vii) reviewing and advising on any budgetary and economic matters relating to the Research Program, including establishing a budget for significant out of pocket expenses (e.g. sequencing, microarray analyses, etc.);
(viii) determining if additional validation work is warranted with respect to any Nominated Target Package, and overseeing any such additional validation work;
(ix) developing the Candidate Target List, and adding and removing Targets to or from the Candidate Target List;
(x) prioritizing Candidate Targets;
(xi) designating Nominated Targets and establishing the number of Candidate Targets to be designated as Nominated Targets;
(xii) on a Nominated Target-by-Nominated Target basis, establishing the requirements for each Nominated Target Package;
(xiii) establishing a list of Final Nominated Targets as of the expiration of the Candidate Target Exclusivity Period pursuant to Section 3.7(c)(iii);
(xiv) the allocation of resources (FTEs) pursuant to the Research Plans;
(xv) serving as a forum for informal resolution of disagreements that may arise in the relation to the Parties activities under the Research Program;
(xvi) determining and approving the overall strategy for publications and presentations pursuant to Sections 5.3 and 5.4;
(xvii) determining which Additional Tumor Models are created pursuant to the Research Plan;
(xviii) determining which Tumor Archives are created and the timing of such creation under the Research Plan;
(xix) determining which cell lines are created in support of (a) the development of new DC tumor models, (b) the development of chimeric mouse tumor models and (c) drug discovery efforts on Collaboration Targets;
(xx) reviewing requests regarding the use of the AVEO bioinformatics platform pursuant to the Research Plan, and overseeing the training of OSI team members on using the AVEO bioinformatics platform ...
Function and Powers of the JSC. During the Research Term, the JSC’s responsibilities shall include: (i) approving each Research Plan, RTP and any amendments thereto; (ii) approving the *** Candidate Criteria; (iii) providing a forum for discussion of the Research Plan, RTP, the status of the Programs, and relevant data; (iv) reallocating resources within and/or among the Programs and the prioritization of Programs; (v) serving as a forum for informal resolution of disagreements that may arise in the relation to the Parties activities under the Programs; (vi) determining and approving the overall strategy for publications and presentations pursuant to Sections 8.3 and 8.4; and (vii) considering and acting upon such other matters as specified in this Agreement.
Function and Powers of the JSC. The JSC shall, in line with the terms and conditions set forth in the Agreement:
(i) define the scope of the research and development activities to be conducted under this Agreement, including by reviewing and approving the initial Development Plan, and each update to the Development Plan and associated Budget, and review progress against the goals in such Development Plan;
(ii) discuss and agree upon the allocation of the Budget to activities under the Development Plan;
(iii) discuss and comment on updates provided by Institute in relation to the Autologous Programs;
(iv) review and discuss proposals for new Indications for Licensed Products to be included within the activities under the Development Plan;
(v) review and discuss potential Targets for consideration as potential New Research Programs;
(vi) consider, discuss and make recommendations with respect to proposals for New Research Programs; [*]= Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
(vii) discuss Atara’s regulatory strategy for IND filing for CTL Products;
(viii) validate and back up the intellectual property strategy;
(ix) review and track publications and proposed publications, and coordinate review and comments on proposed publications by each Party;
(x) establish subcommittees, as appropriate, and support the operation of such subcommittees, including by seeking to resolve disputed matters that may arise at the subcommittees;
(xi) assume a general role of leadership in the collaboration; and
(xii) perform any and all tasks and responsibilities that are expressly attributed to the JSC under this Agreement. Notwithstanding the foregoing roles and responsibilities, unless expressly set forth in this Agreement or the License Agreement, the JSC shall serve solely as a forum for information exchange with respect to any matters that relate to (i) regulatory matters, including the 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 License Agreement, intellectual property strategy, including prosecution, maintenance and enforcement activities.
Function and Powers of the JSC. The JSC will:
(a) prepare, discuss, and approve initial Research Plans for each Program (including the applicable Research Budget set forth therein) and prepare, review, discuss, and approve any amendments or updates that may be necessary or desired to the Research Plans and applicable Research Budget;
(b) oversee the implementation of the Research Plans, including the activities, timing and deliverables thereunder, and coordination of such activities and timing across Programs;
(c) discuss the progress of the Research, Development, and the Programs generally, the Declaration of the Development Candidates and the selection, validation and development of the Licensed Products;
(d) address issues arising in the performance of the Research Plans;
(e) direct and oversee any operating Working Groups on all significant issues, and resolve disputed matters that may arise at the Working Groups;
(f) facilitate the exchange of Know-How or materials (pursuant to Section 4.10, Section 4.11 or Section 5.1, as applicable) as required hereunder; and
(g) perform any and all tasks and responsibilities that are expressly attributed to the JSC under this Agreement or as otherwise agreed by the Parties in writing.
Function and Powers of the JSC. The JSC shall, in accordance with the terms and conditions set forth in the Agreement: 7 Confidential treatment requested 8 Confidential treatment requested
(i) Review, approve, and approve changes to, the Research Plan, Research Budget, Formulation Plan, Formulation Budget, Statement of Work, Manufacturing Plan, Product Plan and Product Budget;
(ii) review progress of the Joint Venture against its goals;
(iii) establish, direct and oversee any subcommittees, as appropriate;
(iv) discuss and attempt to address scientific or technical issues arising in the course of Research Program and Formulation Program activities; and
(v) perform any and all tasks and responsibilities that are expressly delegated to the JSC under the Agreement. Each Party shall be responsible for ensuring that, at all times, its JSC representatives act reasonably and in good faith in carrying out their respective responsibilities hereunder.
Function and Powers of the JSC. The JSC shall, in line with the terms and conditions set forth in the Agreement:
(a) prepare, review and approve the Research Work Plan;
(b) review the Protocol (and any amendments thereto), including standards for the quality and criteria for the selection of patients to provide Collaboration Samples and the processing and use of such Collaboration Samples;
(c) oversee the implementation of the Research Work Plan, and review progress against the goals in such plans, as well as prepare, review and approve any amendments thereto, provided that the approval of any Critical Matter shall require the unanimous consent of the JSC members; Amgen Contract No. [***]
(d) assume a general role of leadership and management of the Program under this Agreement, including serving as a forum for exchanging information and facilitating discussions regarding the conduct of the Program;
(e) alter or add any responsibilities or obligations in or to the Research Work Plan;
(f) establish subcommittees or teams, as appropriate, as described more fully in Section 2.2.4 below;
(g) direct and oversee any operating subcommittee or team;
(h) address and resolve any disputes of any subcommittee; and
(i) perform such other functions as appropriate to further the purposes of this Agreement as allocated to it in writing by the Parties or as otherwise expressly attributed to the JSC under the Agreement.
