JSC Responsibilities. The JSC shall be responsible for overseeing and managing the collaboration with respect to Cell Therapy Products and Collaboration Products, including, without limitation the following functions:
(A) The JSC shall meet at least twice per Calendar Year. Such meetings shall alternate between Amgen and ViaCell locations and be held at such times as are agreed upon by the JSC. At least one JSC meeting per year shall be conducted in person, whereas other JSC meetings may be held in person or by video conference or teleconference. The first meeting shall be held at Amgen's facilities within [**] of the Effective Date, and the agenda for such meeting shall include a review of a program plan for 2004 including a budget for Direct Development Costs for CB001 and any other Cell Therapy Products. If a Party's representative is unable to attend a meeting, such Party may designate an alternate representative to attend such meeting. In addition, each Party may, at its discretion (and with the consent of the other Party, not to be unreasonably withheld), invite additional employees, consultants or scientific advisors to attend any JSC meetings.
(B) The JSC shall review and discuss the progress of ViaCell's Development and manufacturing of Cell Therapy Products and, if applicable, Amgen's Development and Commercialization and ViaCell's manufacturing of Collaboration Products, including review of plans, budgets, clinical trial designs, data, results and other information in appropriate detail to enable the JSC members to meaningfully monitor the progress of the Development, manufacturing and Commercialization efforts of the Parties and to provide advice and feedback relating thereto.
(C) The JSC shall consider the applicability and usefulness of any Materials that a Third Party or Amgen may (in its sole discretion) choose to make available to ViaCell for use in producing or using the Cell Therapy Products and/or the Collaboration Products.
(D) Each year at the first JSC Meeting after the beginning of ViaCell's fiscal year the JSC shall review an annual budget for projected Direct Development Costs for each Cell Therapy Product for the following year prepared by ViaCell in conjunction with ViaCell's annual budget process. At the first JSC meeting after the end of ViaCell's fiscal year, the JSC shall review and reconcile the actual Direct Development Costs for each Cell Therapy Product to the budget previously reviewed. Upon approval by the JSC of the budget and the reconcil...
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 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 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.
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. Except as provided in Sections 5.10, 6.1 and 6.2.1, the JSC shall be responsible for: (a) overseeing the Development and Commercialization activities and Legal Activities under the Collaborative Program (including, without limitation, (i) determining the strategy to achieve Legal Clearance, such as the decision regarding which Locked Manufacturing Process to employ, (ii) determining the enforcement strategy with respect to the Joint Collaboration IP, and (iii) determining the patent prosecution and enforcement strategy with respect to those Product-Specific Patent Rights relevant to the exercise by Sandoz of the licenses granted in Section 2.1); (b) providing overall guidance to the JPT; (c) approving the Annual Collaboration Plan or any changes thereto, including without limitation, the budget contained therein pursuant to Section 5.8 and any changes thereto; (d) reviewing progress toward milestones in the Annual Collaboration Plan; (e) attempting to resolve disputes; and (f) performing such other tasks and undertaking such other responsibilities as are set forth in this Agreement. The JSC shall only act unanimously and each of Momenta and Sandoz, acting through its representatives, shall have one vote on the JSC. The JSC shall meet within thirty (30) days after the Effective Date and, thereafter, at least quarterly during the course of the Collaborative Program. Within thirty (30) days after each meeting, the persons appointed by the JSC will provide Sandoz (on behalf of Sandoz and BCWI) and Momenta with a written report describing, in reasonable detail, the status of the Collaborative Program and the Development and Commercialization of, and Legal Activities with respect to, the Product, a summary of the EXECUTION COPY results and progress to date, any issues requiring resolution, and the agreed resolution of previously reported issues. Disputes shall be resolved pursuant to Article 13.
JSC Responsibilities. The JSC will be responsible during the Research Term for monitoring and coordinating the performance of the Research Collaboration in accordance with the Research Operating Plans. Specific JSC responsibilities will include the following:
(i) Periodic review of the parties’ efforts and progress under the Research Operating Plans;
(ii) Prioritization of specific activities to be performed under the Research Operating Plans;
(iii) Review and approval of any proposed modifications or amendments to the Research Operating Plans;
(iv) Recommending changes to the Hit Class of Interest Criteria and Progressable Lead Class Criteria for the parties’ consideration;
(v) Review and identification of Hit Classes of Interest and Progressable Lead Classes for which pre-clinical Development work should be performed as part of the Research Collaboration;
(vi) Recommendation of possible Hit Classes of Interest and Progressable Lead Classes; and
(vii) Serving as a forum for the parties to discuss any issues arising with respect to the conduct or results of the Research Collaboration.
