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. 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 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 shall be responsible for general management of the Collaboration. Its responsibilities shall include, without limitation, the following:
(a) Reviewing and approving the Five-Year Requirement Schedules, as further described in Section 4.2(a) below;
(b) Reviewing and approving the Five-Year Capacity Projections, as further described in Section 4.2(b) below;
(c) Establishing, maintaining, and updating the Five-Year Plan, as further described in Section 4.2(c) below;
(d) Overseeing the management of the Parties' joint relationship with BIP, with other contractors performing services related to the Product with regard to the Subject Capacity, and with suppliers of raw materials and other supplies for the Product with regard to the Subject Capacity;
(e) Serving as the initial forum for resolution of disputes between the Parties related to matters within the scope of the Collaboration, as set forth in Section 3.4 below;
(f) Establishing the quantities of safety inventories of Product to be maintained by the Parties, except as set forth in Section 5.5 below;
(g) Establishing the operating guidelines pursuant to which the Parties will allocate tasks to accomplish the effective functioning of the Collaboration;
(h) Creating a quality review board and such other subcommittees as the JSC deems necessary or appropriate for the effective functioning of the Collaboration;
(i) Enforcing the responsibilities of and resolving disputes between the finance representatives designated by the Parties as set forth in Section 9.5(b);
(j) Making decisions regarding process improvements as set forth in Section 7.4(a)(i); and
(k) Performing the other tasks specifically set forth herein, as well as any other tasks that the JSC deems necessary or appropriate for the effective functioning of the Collaboration. Except as expressly set forth herein, or as determined by the JSC, the Parties shall be bound by the decisions made by the JSC hereunder. Each Party shall cause its members of the JSC to act in accordance with, and perform the functions of the JSC required by, this Agreement.
Role of JSC. The JSC shall be responsible for oversight, strategic planning, and overall management and coordination of the activities to be undertaken by the Parties with respect to Development of the Collaboration Products. This will include responsibility for:
(a) strategic oversight of the Development of Collaboration Products for the Field, including approval of a global regulatory strategy for Collaboration Products in the Field;
(b) approval of all Development Plans (and the related Development Budgets) for Collaboration Products, and any material amendments to such plans, including agreeing at the appropriate time on the respective target product profiles for the various Collaboration Products as part of the Global Development Plan;
(c) monitoring and coordinating the Parties’ performance of Development Plans;
(d) approval of any proposed increase of a previously agreed Development Budget by an amount greater than [***]; and
(e) monitoring the status of and coordinating Manufacturing of Collaboration Products for Development and Commercialization purposes;
(f) review and approval of protocols for all pre-clinical studies and Clinical Trials and any post-marketing clinical studies, risk evaluation and mitigation strategies (“REMS”) or other post-marketing commitments or requirements imposed by Regulatory Authorities involving Collaboration Products in the Field to be undertaken by or on behalf of the Parties;
(g) periodic review of the results arising from Development of Collaboration Products in the Field;
(h) monitoring and coordinating the performance by each Party of the regulatory activities in respect of the Collaboration Products in the Field for which it is responsible;
(i) establishment of the contents of the Global Registration Dossier to be used by the Parties to prepare BLAs for the Collaboration Products in the Field in the Territory and the Retained Territory, and allocation of responsibility between the Parties for completing each section of such Global Registration Dossier;
(j) review of Regulatory Filings for Collaboration Products in the Field prior to their submission to Regulatory Authorities; and
(k) facilitating the exchange between the Parties of data and information regarding Development and regulatory activities for Collaboration Products.
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 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 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.
