JSC Responsibilities Sample Clauses

JSC Responsibilities. The JSC shall perform the following functions: (1) without prejudice to Clause 5.1(C)(3), at least [***] throughout the Term of this Agreement, review and discuss strategies and detailed plans (and progress against such plans) for the Development and Manufacture of Licensed Product in the Field and any Substantive Amendments (as defined below) to any such plans, as well as a more high-level review and discussion of the Commercialisation Plan; (2) review and discuss the high-level budgeted costs for Development and Manufacturing and actual spendings against such budgeted costs for each Calendar Quarter; (3) approve [***] the Development Plan, Manufacturing Plan and Technology Transfer Plan and (to the extent provided in this Agreement) any Commercialisation Plan for the subsequent Calendar Year, including budget and timelines, and subsequently during such Calendar Year approve any proposed Substantive Amendments to such plans; (4) discuss and approve any extension of any of the Development Diligence Milestone deadlines provided for in Clauses 4.3(A)(1) and 4.3(A)(2), or any suspension of any Development Diligence Milestone as provided for in Clause 4.3(A)(4); (5) discuss and approve any proposal to Develop the [***] and the Development Plan for such [***]; (6) discuss and determine the need for any Third Party IPR licences, as provided for in Clause 6.8; (7) discuss and approve the need to use any platform technologies Controlled by Genmab, as set out in Clause 1.64, for the Development or Commercialisation of Licensed Product as contemplated in this Agreement; (8) discuss and approve [***]; (9) discuss and approve [***] (10) appoint sub-committees as appropriate to facilitate coordination and cooperation between the Parties or otherwise to further the purposes of this Agreement [***]; (11) discuss any dispute between the Parties as to whether a milestone payment has been triggered; (12) serve as the first forum for the settlement of disputes or disagreements that are unresolved by the Development Committee, unless otherwise indicated in this Agreement; (13) discuss and approve any proposed extension of the Development Committee Term; (14) review and approve any Development Costs in excess of [***] percent [***]%) prior to payment in accordance with Clause 5.4(A); and (15) perform such other functions as appropriate to further the purposes of this Agreement as determined by the Parties. For the purposes of the foregoing: (i) the term “Substantive Amendment”...

JSC Responsibilities. The JSC’s activities shall include the following responsibilities with regard to the Diagnostic Test: (a) review, confirmation, modification and/or update of the Development Plan, the Regulatory Plan and the Commercialization Plan, subject to final approval by the Parties; (b) monitoring of the development, regulatory and commercialization activities under the Development Plan, the Regulatory Plan and Commercialization Plan, respectively; (c) resolution of issues raised by the Alliance Leads; (d) exchange of development and commercialization information; and (e) alignment of the regulatory submissions and Regulatory Approvals between any Epizyme Product and the Diagnostic Test. The JSC shall keep accurate and complete confidential minutes of its meetings. The Alliance Leads shall be responsible for taking such minutes and distributing them to the JSC members for their review and comment within [**] business days after the date of each meeting, and within [**] business days after the receipt thereof, the JSC members shall remit such minutes back to the Alliance Leads with their comments, if any. The JSC members shall in good faith attempt as quickly as is reasonably possible to resolve any disputes as to the content of such minutes so as to have a final agreed version as quickly as is reasonably possible. Each Party shall be responsible for all expenses incurred by its representatives on the JSC in connection with performing their duties hereunder, including all costs of travel, lodging and meals. For the avoidance of doubt, the JSC shall not have the authority to amend this Agreement, and shall have authority to amend the Development Plan, the Regulatory Plan and/or the Commercialization Plan only as expressly set forth herein, with the written consent of the Parties.

JSC Responsibilities. The JSC will have oversight and information sharing responsibilities and functions with respect to the worldwide Development, Manufacture, Commercialization, and other Exploitation of the Products. The JSC will, amongst other duties and responsibilities: i) [***]; ii) [***]; iii) [***]; and iv) [***].

JSC Responsibilities. The JSC shall serve as a forum for the Parties to share information regarding the Development, Manufacture, and Commercialization of the Compound and/or Products in the Field in the Territory and to facilitate coordination between the Parties, but shall not have any decision-making authority with respect to the Parties’ activities under this Agreement. Additionally, Evommune shall share information relating to the Development and Commercialization of the Product outside of the Territory to the extent necessary or useful for Maruho to Develop, Manufacture, and/or Commercialization the Compound and any Product in the Field in the Territory.

JSC Responsibilities. The JSC shall oversee the Development, and Commercialization of the Licensed Products in the Licensed Territory. In particular, the JSC shall: (i) serve as a forum for sharing information, including receiving Development Reports and any additional reports, including any serious adverse event report, for Licensed Drug Substance and Licensed Product in the Licensed Field in the Licensed Territory; (ii) review and serve as a forum for discussing plans and budgets, including the Joint Development Plan and Commercialization Plan and review amendments thereto; (iii) coordinate and review any material safety and quality issues regarding the Licensed Drug Substance and Licensed Product in the Licensed Territory; (iv) create and oversee any subcommittees or working groups as the JSC may deem appropriate; and (v) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

JSC Responsibilities. The JSC shall have the following responsibilities with respect to the Technology Collaboration: 1. oversight of all activities relating to the Technology Collaboration;

JSC Responsibilities. The JSC shall be responsible for: (a) coordinating the activities of the Parties under this Agreement and providing a forum to facilitate communications between the Parties under this Agreement; (b) reviewing and discussing the Development, Manufacture and Commercialization of the Licensed Compound and Licensed Products in the Field in the Territory, including the activities of Qilu and its Sublicensees to (i) Develop the Licensed Compound and Licensed Products in the Field in the Territory in accordance with the Development Plan, (ii) Manufacture quantities of the Licensed Compound and Licensed Products for use in the Field in the Territory, (iii) following Regulatory Approval, launch, market, distribute and sell Licensed Products in the Field in the Territory, and (iv) subject to Section 2.2 and any consent required by Sesen for a sublicense of the License, Qilu’s selection of Third Party service providers to support Qilu’s efforts to Develop, Manufacture and Commercialize the Licensed Compound and Licensed Products in the Field in the Territory; (c) reviewing, discussing and approving changes to the Development Plan, overseeing the implementation of the Development Plan, and reviewing and discussing the Data and results of the Development activities under the Development Plan, in each case, subject to the provisions of Section 3.5, below; (d) discussing at a high-level and exchanging relevant information relating to the Development, Manufacture and Commercialization activities for the Licensed Compound and Licensed Products undertaken by Sesen and its Affiliates and sublicensees outside of the Field and outside of the Territory (i) to the extent relevant to the Development, Manufacture and Commercialization of the Licensed Compound and Licensed Products in the Field in the Territory, and (ii) to the extent that Sesen has the right to disclose such information to Qilu; and (e) performing such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or allocated to it by the Parties in writing by mutual agreement.

JSC Responsibilities. The JSC shall be responsible for: (i) reviewing each Party’s Business Plan; (ii) reviewing progress of LifeCell MR marketing activities and Novadaq research and development activities; (iii) reviewing all Device specifications and clinical study plans and schedules; (iv) attempting to resolve disputes, if any; and (v) performing such other tasks and undertaking such other responsibilities to which the Parties may jointly agree. The JSC shall only act unanimously and each of LifeCell MR and Novadaq, acting through its representatives, shall have one vote on the JSC. If the JSC is unable to agree on any issue, the JSC may escalate such issue to the President (or its equivalent) of LifeCell MR and CEO of Novadaq respectively for resolution. If the issue remains unresolved sixty (60) days after the Parties agree to escalate to the President of LifeCell MR (or its equivalent) and CEO of Novadaq, or their respective designee, then the dispute shall be settled by the Section 22.12 herein (Dispute Resolution).

JSC Responsibilities. The JSC shall be responsible for: (a) coordinating the activities of the Parties under this Agreement and providing a forum for and facilitate communications between the Parties under this Agreement; (b) reviewing, discussing and approving changes to the Development Plan, overseeing the implementation of the Development Plan, and reviewing and discussing the data and results of the Development activities under the Development Plan, in each case, subject to the provisions of Section 3.5, below, (c) reviewing and discussing the Commercialization Plan and Commercialization of the Licensed Products in the ZAI Territory; (d) reviewing, discussing and coordinating scientific presentations and publication plans with respect to the Licensed Compound, Licensed Product and any results arising therefrom during the course of the Development Plan in the ZAI Territory, and (e) performing such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or allocated to it by the Parties in writing by mutual agreement.