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:
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 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 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. 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’s role with respect to [***].
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. The JSC shall be responsible for (i) the overall management of the Research Program and Development Plan, (ii) approval of each Research Plan and changes and updates to any Research Plan, (iii) the monitoring, reviewing and recording of the progress of the Research Program, [***], (vii) review and discuss the status of transfer of the RAPT Manufacturing Technology for the Product and the manufacture of the Product in the Territory, (viii) review all proposed and active [***], and (ix) review each Product prior to launch and during Commercialization in the Territory, [***]. As needed, the JSC shall establish subcommittees and working groups, such as a joint development committee, that will report to the JSC to further the objectives of the Development of the Product in the Field in the Territory.
Role of JSC. The JSC will be responsible for:
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...
