Role of JSC Sample Clauses

Role of JSC. The conduct of the R&D Research Plan will be coordinated by the Joint Steering Committee. If a consensus is not reached among the members of the Joint Steering Committee with respect to the conduct of activities under the R&D Research Plan, ALNYLAM’s representatives on the JSC will have the deciding vote on that matter, provided that such decision is otherwise made in a manner consistent with this Agreement.

Role of JSC. The conduct of the PLK Research Plan will be coordinated by the Joint Steering Committee. The JSC will attempt to act by consensus in respect of all matters arising under or in connection with the PLK Research Plan. If such a consensus is not obtainable with respect to a matter, PROTIVA’s representatives on the JSC will, prior to an exercise by ALNYLAM of the Opt-In Right, have the deciding vote on that matter so long as they exercise such right in a manner that is consistent with this Agreement.

Role of JSC. The JSC will be responsible for (i) the overall management of the Research Program, including serving as a forum for exchanging information and facilitating discussions regarding the conduct of the Research Program, (ii) approving the adoption of the LO Criteria and the LO Timeline for each Designated Target, (iii) reviewing, revising and approving (A) each Research Plan prepared by Schrödinger in consultation with BMS for any Substitute Target that is selected as a Designated Target in accordance with Section 3.4(c) (including the Primary Activity, LO Criteria, the LO Timeline and DC Criteria with respect thereto) and recording the date of approval of the Research Plan for each new Substitute Target in the JSC minutes in accordance with Section 3.4(c) and (B) any changes, modifications, amendments and updates to any established Research Plan for a Designated Target, (iv) the monitoring, reviewing and recording of the progress of the Research Program, including all activities performed by the Working Groups, (v) on a Designated Target-by-Designated Target basis, confirming whether a Licensed Collaboration Compound has achieved the LO Criteria or DC Criteria (as applicable) for such Designated Target in accordance with Section 3.5(b) or Section 3.6(c) (as applicable), (vi) reviewing and discussing progress in any research and Development and other activities that the Parties perform in relation to Licensed Collaboration Compounds and Licensed Collaboration Products in the Field, including the use of any Third Party contractors by Schrödinger in the performance of Schrödinger’s obligations in connection with the Research Program, subject to Section 3.12, (vii) reviewing and discussing any Permitted Reserved Target Activities, including the nature and scope of activities to be performed and the results thereof, (viii) reviewing and discussing proposed modifications to the Reserved Target List, (ix) facilitating the prosecution of the Product Specific Patents in accordance with Article 9 below, (x) reviewing, revising and approving a charter prepared by the Alliance Managers in accordance with Section 2.1(d) for each Working Group, (xi) [***] and (xii) performing such other responsibilities as expressly delegated to the JSC as set forth in this Agreement or as may be mutually agreed by the Parties in writing from time to time. As needed, the JSC shall establish subcommittees and working groups that will report to the JSC to further the objectives of the Resear...

Role of JSC. The JSC shall approve the overall strategy and positioning of all material meetings, submissions and filings for Products with FDA, EMEA and Regulatory Authorities of other Major Market countries prior to their conduct, submission or filing, based upon reasonably detailed reports and summaries of such meetings, submissions and filings presented to the JSC by the Party with primary responsibility for such meeting, submission or filing (as described in Sections 5.1(a), (b) and (c) above), and all such meetings, submissions and filings shall conform with the strategy approved by the JSC. In connection with such review, such Party shall promptly provide to the JSC such additional information regarding a proposed meeting, submission or filing as the other Party may reasonably request.

Role of JSC. The JSC will (i) be a forum for the exchange and discussion of, and the Parties agree that through the JSC (or its designees) they shall exchange and discuss, information related to the progress under and plans for the conduct of each Party’s activities under this Agreement, including which Anti-Exhaustion Components within the Lyell Anti-Exhaustion Technology will be generated in connection with each Lyell Development Program and transparency into the innovations and data resulting from Clinical Trials and other scientific testing related to any Lyell Anti-Exhaustion Technology or other related intellectual property rights developed by or on behalf of a Party or its Affiliates under this Agreement or licensed under any of the Lyell License Agreements, (ii) decide the Success Criteria for Additional Constructs for Additional Development Activities and decide whether such Success Criteria have been met as described in Section 3.9, (iii) decide whether an actual or potential Collaboration Program is or would be an Active GSK Program as described in Section 3.3(e), (iv) regularly review and discuss (including concerns a Party may have about) Targets to potentially be added as Collaboration Targets, (v) be a forum for the Parties to discuss, and the Parties agree that through the JSC (or its designees) they shall discuss, opportunities for the Parties to collaborate with respect to CAR T-Cell Therapies beyond the activities under this Agreement, including, during the [*] (or such longer term during which Lyell is conducting: (x) Additional Development Activities with respect to any Collaboration Program, or (y) any Lyell Development Program), with respect to the current progress of development and application of Lyell Technology and technology Controlled by GSK (or its Affiliates) related to [*] that may benefit the Collaboration Programs and the Parties’ activities [*], (vi) evaluate, and the Parties agree that through the JSC (or its designees) they shall disclose, any general progress of Lyell Anti-Exhaustion Technology and, insofar as it is related to a Collaboration Program, GSK’s or its Affiliates’ TCR and CAR technology and improvements of either of the foregoing, (vii) agree on any changes to Exhibit 1.2 for the information to be provided in an Academic PoC Data Package for a particular Lyell PoC Development Program (which shall not be subject to resolution pursuant to Section 16.3), and (viii) make such other decisions and perform such other duties as...

Role of JSC. In addition to its overall responsibility for monitoring and providing a forum to discuss and oversee the Parties’ activities under this Agreement, the JSC will be responsible for: (a) [***] (b) [***] (c) [***] (d) [***] (e) [***] (f) [***] (g) [***] (h) [***] (i) [***] (j) [***] (k) [***] (l) [***] (m) [***] As needed, the JSC will establish Working Groups in accordance with Section 3.2 that will report to the JSC to further the objectives and intent of this Agreement.

Role of JSC. The JSC will be responsible for (i) oversight for all aspects of the collaboration of uniQure and BMS under this Agreement, (ii) oversight for and the overall management (through the Joint Discovery Working Group) of the Research Program, and for approving changes and updates to the Research Plan and the Budget, (iii) oversight for and the overall management (through the Joint Early Development Working Group) of the Early Development activities for Therapeutics and Products, (iv) seeking input from uniQure on the Development by BMS of Therapeutics and Products and monitoring the Development progress of each Therapeutic and Product by BMS, (v) oversight for and the overall management (through the Joint CMC Working Group) of CMC activities in connection with the Development of Therapeutics and Products, (vi) monitoring, reviewing and recording of the progress of the Research Program, (vii) setting and monitoring the spending against the Budget for Research Program Costs, as set forth in the Research Plan, (viii) facilitating the prosecution of the Product Specific Patents in accordance with Article 9 below (and for the avoidance of doubt the JSC will have no authority to determine whether a Patent is a Product Specific Patent), (ix) documenting the designation by BMS of Collaboration Targets (including the replacement of a Collaboration Target with a Replacement Target), (x) providing Gene Therapy regulatory guidance regarding the nature and frequency of interactions with Regulatory Authorities and issues to be raised and addressed with Regulatory Authorities in connection with the Development of Therapeutics and Products, (xi) providing assistance in the review of Regulatory Materials, and monitoring the submission of Regulatory Materials for each Therapeutic and Product (in particular each ECN) through the First Commercial Sale of each such Therapeutic and Product, and (xii) reviewing the Commercialization activities of each Therapeutic and Product (in particular each ECN) by BMS and other Related Parties. The JSC shall also serve as an information sharing forum for keeping uniQure informed of Development activities being conducted by BMS and other Related Parties for Therapeutics and Products. As needed, the JSC shall establish subcommittees and working groups (which in each case shall include representation by each Party but it shall be within the discretion of the JSC whether an equal number of representatives from each Party should be on a particular s...

Role of JSC. In addition to its overall responsibility for monitoring and providing a forum to discuss and oversee the Parties’ activities under this Agreement with respect to the Opt-In Licensed Target Program, the JSC will be responsible for: (i) facilitating the flow of information between the Parties with respect to the Opt-In Compounds and the Opt-In Products, (ii) reviewing and discussing reports from the JDC and JCC and providing guidance thereto and directing activities of the JDC and JCC, (iii) during the Opt-In Term, reviewing, discussing and approving the initial Opt-In Global Development Plan (including the initial Opt-In Global Development Budget) submitted by Blueprint in accordance with Section 6.3(a)(i), (iv) reviewing, discussing and approving amendments to the Opt-In Global Development Plan (including the Opt-In Global Development Budget) submitted by the JDC in accordance with Section 9.5(c)(ii), (v) reviewing, discussing and approving the initial Opt-In Commercialization Plan and Operating Budget and any amendments thereto submitted by the JCC in accordance with Section 9.6(c), (vi) monitoring and serving as a forum for discussing strategies for obtaining Regulatory Approvals for Opt-In Compounds and the Opt-In Products in the Field and in the Opt-In Territory, (vii) attempting to resolve issues presented to it by, and disputes within the JDC or the JCC, as applicable, and (viii) carrying out such other responsibilities as expressly delegated to the JSC as set forth in this Agreement or as may be mutually agreed by the Parties from time to time. As needed, the JSC will establish Working Groups in accordance with Section 9.7 that will report to the JSC to further the objectives and intent of this Agreement.

Role of JSC. The JSC will be responsible for: (i) overseeing the Research Program, and for approving changes and updates to the Research Plan; (ii) monitoring, reviewing and recording the progress of the Research Program; (iii) facilitating the prosecution of the Product Specific Patents in accordance with Article 9 below; (iv) reviewing the Reserved Target List regularly and, in any event, at least once every six (6) months until the date that is three (3) calendar years after the Effective Date; (v) approving a Target as an Additional Target and a Reserved Target as a Replacement Target; (vi) if necessary, further refining the Lead Optimization Criteria for each Collaboration Target; (vii) reviewing whether a given Licensed Compound has successfully achieved the Lead Optimization Criteria; (viii) in respect of a Collaboration Target where no Licensed Compound has achieved the Lead Optimization Criteria, discussing whether any of those Licensed Compounds are likely to achieve the Lead Optimization Criteria and whether Exscientia should cease development of those Licensed Compounds; Certain confidential information contained in this document, marked by [****], has been omitted because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential. (ix) reviewing each Lead Optimization Data Package and discussing whether any further information is required for that Lead Optimization Data Package to be complete; (x) agreeing upon the Development Candidate Criteria for a Licensed Compound, which must include the minimum criteria set forth on Exhibit C and thereafter further refining the Development Candidate Criteria as needed; (xi) reviewing whether a given Licensed Compound has successfully achieved the Development Candidate Criteria; (xii) reviewing each Development Candidate Data Package and discussing whether any further information is required for that Development Candidate Data Package to be complete; (xiii) sharing of results under the Research Program; (xiv) establishing a procedure for the Parties’ publication of results of the Research Program; (xv) reviewing (through the Patent Contacts) patent applications claiming Licensed Compounds or Licensed Products prior to filing; (xvi) establishing subcommittees with an equal number of members from each Party that will report to the JSC to further the objectives of the Research Program (each a “Subcommittee”); and (xvii) resolving disputes that arise in any Subcommittee establis...

Role of JSC. The JSC shall oversee and review VivaCell’s activities with respect to any Project Plan, and determine any necessary amendments or modifications to, or the termination of, any Project Plan from time to time. The JSC shall not have power to amend or modify this Agreement or to impose additional economic burdens on either party beyond those specifically contemplated by this Agreement without the prior written consent of the party on which such burden is imposed.