JCC Responsibilities Sample Clauses

JCC Responsibilities. Except as otherwise set forth herein, the JCC shall provide strategic oversight of all Promotional activities for the Products hereunder, it being understood that Santarus shall be responsible for directing such Promotional and marketing activities. The responsibilities of the JCC shall be exercised consistent with this Agreement and shall include, but shall not be limited to: (a) reviewing the Annual Plan as contemplated by Section 4.5(a); (b) reviewing material modifications by Santarus to the Annual Plan or the Launch Plan; (c) reviewing Santarus’ Product Promotion strategies and objectives, including Product positioning, messaging and branding; (d) if applicable, monitoring the Depomed Sales Force call plan for coordination with the Santarus Sales Force; (e) monitoring advertising placement and market responses, including any post-implementation reviews; (f) reviewing and approving any Volume Forecasts and reviewing any Sample forecasts, consistent with Section 6.3; (g) establishing pricing for commercial sale of Products by or on behalf of Depomed, including the timing of any pricing changes; (h) reviewing sales incentive compensation plans for the Santarus Sales Force related to the Products; (i) establishing contracting guidelines for the distribution of the Products (or if no such guidelines have been established, approving any new or amended contracts); (j) establishing contracting guidelines for the managed care and government markets (or if no such guidelines have been established, approving any new or amended contracts); (k) proposing any new packaging design for the Products (subject to Depomed’s approval, and followed by and subject to applicable FDA and other Legal Requirements); (l) establishing the Net Sales forecast for 2009 for purposes of calculating the minimum Advertising/Marketing/Educational Expenses for that year in accordance with Section 4.1(d); (m) reviewing and approving any Product voucher, coupon, loyalty card or other co-pay assistance programs; (n) reviewing and approving any proposed material capital expenditures relating to the manufacture of the Products; and (o) such other functions as may be mutually agreed upon by the parties from time to time. For the avoidance of doubt, (i) the JCC shall not have any review or approval rights with respect to any matters relating to the development of the Products, (ii) any decisions of the JCC with respect to matters which relate to Regulatory Approval for a Product shall require De...
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JCC Responsibilities. In particular, the JCC shall be responsible for:
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JCC Responsibilities. The JCC will oversee the Commercialization strategy of the Licensed Product(s) in the Partner Territory, review and approve the China Commercialization Plan and any amendment thereof, and oversee the implementation of the China Commercialization Plan, in addition to performing other responsibilities explicitly assigned to it in this Agreement, including establishing FTE Rate.
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JCC Responsibilities. The responsibilities of the JCC shall also include, but shall not be limited to: (a) preparing, or overseeing the preparation of, the Global Co-Commercialization Plan (and the related Global Co-Commercialization Budget) for the Commercialization activities to be done centrally, and updating each such Plan not less frequently than once per Contract Year; (b) preparing the overall global strategy for Commercialization of VEGF Products in the Territory, including, without limitation, VEGF Product branding, positioning, core messages, and other tactical plans as well as the overall pricing strategy; (c) considering and selecting global Product Trademarks for VEGF Products and giving guidance to the Joint Country Commercialization Sub-Committee on trade dress; (d) establishing as sub-committees of the JCC the Joint Country Commercialization Sub-Committees; (e) developing and implementing plans and policies regarding journal and other publications with respect to VEGF Products; (f) making recommendations to the JSC with respect to target profiles for the VEGF Products; and (g) considering and acting upon such other matters as are specified in this Agreement or by the JSC.
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JCC Responsibilities. In addition to its overall responsibility for developing and agreeing the Commercialization Plan, the JCC shall, in particular: (a) prepare and agree the Commercialization Plan and associated budget and review and approve any annual updates (or any other updates) thereto submitted by the JPT to the JCC; (b) establish a commercialisation strategy for the Companion Diagnostics; (c) following the First Commercial Sale of Licensed Product, develop, approve and coordinate a publication strategy relating to the Licensed Products, and the plan for scientific presentations and publications, in accordance with Article 17, which strategy shall indicate any such publications that require prior approval of the JCC and a process for approval of such publications, save that publication strategy relating to Research Programs shall be reviewed and coordinated by the JRC; and (d) performing such other duties as are expressly agreed by the Parties or otherwise assigned to the JCC in this Agreement.
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JCC Responsibilities. The JCC shall be responsible for the following items as they relate to the Licensed Products in the Field in the Territory: (i) reviewing the Commercialization Plans and evaluating the progress of the Commercialization activities for each Licensed Product under such Commercialization Plans; (ii) reviewing and approving the compliant promotional materials; (iii) performing such other functions as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement; and (iv) setting up a distribution committee under the JCC, which will be the governance body to review key performance indicators (KPIs), resolve disputes, make decisions and agree on matters related to distribution activities under this Agreement, including without limitation the selection of distributors.
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JCC Responsibilities. In addition to its overall responsibility for monitoring the activities of the Parties under this Agreement with respect to Joint Selected Candidates following completion of Phase III Clinical Trials thereof and during the supply, manufacture and commercialization of Joint Selected Candidates resulting from such Phase III Clinical Trials, the JCC shall, in particular, with respect to each Joint Selected Candidate (and Products containing such Joint Selected Candidates): (a) review and approve a worldwide commercialization plan; (b) review and approve changes to the worldwide commercialization plan; (c) provide consultation to the JDC regarding the Co-Development Plan, and amendments thereto, pertaining to Joint Selected Candidates (and Products containing such Joint Selected Candidate); (d) receive reports regarding material submissions to Regulatory Authorities pertaining to Joint Selected Candidates (and Products containing such Joint Selected Candidate), as needed; 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. (e) review manufacturing and commercial supply plans pertaining to Joint Selected Candidates (and Products containing such Joint Selected Candidate);
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JCC Responsibilities. In addition to its overall responsibility for monitoring the *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. activities of the Parties under this Agreement with respect to Therapies containing a Joint Selected Candidate, following initiation of Phase III Clinical Trials thereof and during the supply, manufacture and commercialisation of any Therapy utilising a Joint Selected Candidate resulting from such Phase III Clinical Trials, the JCC shall, in particular, with respect to each such Therapy utilising such Joint Selected Candidates): (a) review and approve an initial worldwide commercialisation plan; (b) review and approve changes to the then-current worldwide commercialisation plan; (c) receive reports regarding material submissions to Regulatory Authorities pertaining to any Therapy utilising a Joint Selected Candidate, as needed; (d) review manufacturing and commercial supply plans pertaining to any Therapy utilising a Joint Selected Candidate; (e) review and, to the extent permitted by Applicable Laws, approve any applicable policies with respect to pricing reimbursement required for sale and supply of any Therapy utilising a Joint Selected Candidate; (f) subject to the Co-Commercialisation Agreement, discuss and agree to mechanisms for co-promotion of any Therapy utilising a Joint Selected Candidate in those specific countries where co-promotion will occur in accordance with the Co-Commercialisation Agreement; (g) discuss pre-marketing and marketing activities pertaining to any Therapy utilising such Joint Selected Candidate; (h) discuss launch of any Therapy utilising such Joint Selected Candidate; (i) receive from each Party reports on Net Sales of any Therapy utilising such Joint Selected Candidate; and (j) perform such other responsibilities as are assigned to the JCC in this Agreement or in the Co-Commercialisation Agreement.
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JCC Responsibilities. The JCC shall be limited to the following responsibilities in connection with this Agreement: (a) reviewing the status of Licensed Products other than TC Products, including material Development and Manufacturing matters; (b) approval of any request by DSE to conduct a Selected Clinical Activity for a Licensed Product other than a TC Product by or under the oversight of DSE in the DSE Territory, including the approval of the relevant protocol and related documentation; (c) addressing any other matters regarding the Development or Manufacturing of Licensed Products other than TC Products referred to the JCC by the terms of this Agreement; and (d) performing such other activities as the Parties agree in writing shall be the responsibility of the JCC. Section 6.1 7(c) (Tie-Breaking) is hereby deleted in its entirety and replaced with the following:
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JCC Responsibilities. In addition to its overall responsibility for monitoring the activities of the Parties under this Agreement with respect to Therapies containing a Joint Selected Candidate, following initiation of Phase III Clinical Trials thereof and during the supply, manufacture and commercialisation of any Therapy utilising a Joint Selected Candidate resulting from such Phase III Clinical Trials, the JCC shall, in particular, with respect to each such Therapy utilising such Joint Selected Candidates): (a) review and approve an initial worldwide commercialisation plan; (b) review and approve changes to the then-current worldwide commercialisation plan; (c) receive reports regarding material submissions to Regulatory Authorities pertaining to any Therapy utilising a Joint Selected Candidate, as needed; (d) review manufacturing and commercial supply plans pertaining to any Therapy utilising a Joint Selected Candidate; (e) review and, to the extent permitted by Applicable Laws, approve any applicable policies with respect to pricing reimbursement required for sale and supply of any Therapy utilising a Joint Selected Candidate; (f) subject to the Co-Commercialisation Agreement, discuss and agree to mechanisms for co-promotion of any Therapy utilising a Joint Selected Candidate in those specific countries where co-promotion will occur in accordance with the Co-Commercialisation Agreement; (g) discuss pre-marketing and marketing activities pertaining to any Therapy utilising such Joint Selected Candidate; (h) discuss launch of any Therapy utilising such Joint Selected Candidate; (i) receive from each Party reports on Net Sales of any Therapy utilising such Joint Selected Candidate; and (j) perform such other responsibilities as are assigned to the JCC in this Agreement or in the Co-Commercialisation Agreement.
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