Function and Powers of the JSC Sample Clauses
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 will:
(a) prepare, discuss, and approve initial Research Plans for each Program and prepare, review, discuss, and approve any amendments that may be necessary or desired to the Research Plans;
(b) oversee the implementation of the Research Plans, including the activities, timing and deliverables thereunder, and coordination of such activities and timing across Research Programs;
(c) discuss the progress of the Research, Pre-Clinical Development, and the Programs generally, the validation and development of the Collaboration Targets and the selection, validation and development of the Licensed Products;
(d) provide a forum for the Parties to share and discuss information relating to the (i) Research and validation of the Collaboration Targets (including Replacement Targets), (ii) Research and Pre-Clinical Development of the Licensed Products, including the results of the activities being carried out under the Research Plans, (iii) manufacturing and CMC development activities being carried out under the Supply Agreements, and (iv) Clinical Development of any Co-Funded Product under this Agreement pursuant to 5.3;
(e) address issues arising in the performance of the Research Plans;
(f) direct and oversee any operating Working Groups on all significant issues, and resolve disputed matters that may arise at the Working Groups; WEIL:\97737446\1\59474.0121 EXECUTION VERSION
(g) 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;
(h) following Precision’s delivery of a Co-Funding Option Interest Notice in accordance with Section 5.3.1, facilitate Lilly’s provision of information to Precision in response to questions from Precision relating to the Lilly Clinical Development Plan and facilitate Lilly’s provision to Precision of written copies of any updates or amendments to the Lilly Clinical Development Plan; and
(i) 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: (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:
(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.
Function and Powers of the JSC. The JSC shall, in line with the terms and conditions set forth in the 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 2.2.5 (Decisions):
(i) coordinate the Parties’ activities under this Agreement;
(ii) [***];
(iii) [***];
(iv) oversee the implementation of each Work Plan and review and serve as a forum for discussion of the results of the activities being carried out thereunder;
(v) serve as an information-sharing forum for Preclinical Research for each Collaboration Product;
(vi) review and comment on any material strategy changes with respect to any Work Plan;
(vii) establish subcommittees, as appropriate, as described more fully in Section 2.2.3(d) (Subcommittees) below;
(viii) direct and oversee any subcommittee;
(ix) resolve disputed matters that may arise at the subcommittees; and
(x) perform any and all tasks and responsibilities that are expressly attributed to the JSC under this Agreement.
Function and Powers of the JSC. The JSC shall, consistent with the terms and conditions set forth in this Agreement:
(i) coordinate the Parties’ activities under this Agreement;
(ii) define the Collaboration EGFR Budget as soon as practicable after the Effective Date for inclusion in the Preclinical Development Plan and EGFR Initial Development Plan;
(iii) define each Program, and prepare and approve (x) the Preclinical Development Plan for the Programs and any amendments thereto and, with respect to EGFR Products, create the EGFR Initial Development Plan and Collaboration EGFR Budget, and update each on an annual basis or as otherwise agreed upon by the Parties and (y) the EGFR Global Development Plan, or any amendments thereto, and review progress against the goals in such plans;
(iv) oversee the implementation of the Preclinical Development Plan, the EGFR Initial Development Plan and the EGFR Global Development Plan and review and serve as a forum for discussion of the results of the activities being carried out thereunder including, without limitation, the activities related to the Exploitation of each EGFR Product;
(v) discuss the Formats for the Products;
(vi) define and coordinate regulatory strategy for IND filing for the EGFR Product;
(vii) establish subcommittees or teams, as appropriate, as described more fully in Section 2.1.3(d) below;
(viii) direct and oversee any operating subcommittee or team;
(ix) resolve disputed matters that may arise at the subcommittees or teams;
(x) perform any and all tasks and responsibilities that are expressly attributed to the JSC under the Agreement; and
(xi) discuss activities to support CytomX’s diligence efforts relating to the selection of the CytomX Target.