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...
JCC Responsibilities. In particular, the JCC shall be responsible for:
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.
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.
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.
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);
JCC Responsibilities. The JCC shall be limited to the following responsibilities in connection with this Agreement:
(a) discussing, reviewing and approving the Development Plans and amendments or modifications to the Development Plans for Licensed Products other than TC Products;
(b) discussing, reviewing and approving the Development of new formulations of Licensed Products other than TC Products;
(c) discussing and reviewing the implementation of the Development Plans for Licensed Products other than TC Products, and reviewing the status and results of such Development Plans;
(d) discussing, reviewing and approving Clinical Studies, including post-marketing studies proposed to be sponsored or supported (through supply of Licensed Products other than TC Products) by DS or Esperion (in respect of the Development Pre-Approval Clinical Studies in South Korea and Taiwan), as detailed in Section 2.1.3 (Development in South Korea and Taiwan)), of Licensed Products other than TC Products in the DS Territory, including the approval of the relevant study design or summary of the relevant protocol and related documentation;
(e) discussing and reviewing the status of Licensed Products other than TC Products, including material Development matters in the Esperion Territory and the DS Territory;
(f) discussing and reviewing the Global Branding Strategy;
(g) discussing and reviewing the DS Territory Commercialization Plans and amendment or modifications to the DS Territory Commercialization Plans;
(h) reviewing representative samples of DS Territory Promotional Materials developed for use in the DS Territory as provided in Section 4.3.2 (DS Advertising & Promotional Materials);
(i) discussing, reviewing and approving Trademarks for the DS Territory pursuant to Section 4.3.4 (Product Trademarks);
(j) reviewing a publication strategy pursuant to which the Parties may publish certain key results achieved in connection with this Agreement as provided in Section 7.2.1 (Publication);
(k) overseeing the JCC's subcommittees and ensuring effective participation in each such committee's operations by any of its members;
(l) 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
(m) 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:
JCC Responsibilities. The JCC shall be limited to the following responsibilities in connection with this Agreement:
(a) reviewing the status of Licensed Products, including material Development and Manufacturing matters;
(b) approval of any request by DSE to conduct a Selected Clinical Activity 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 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.
JCC Responsibilities. The JCC shall have the following responsibilities with respect to the Development, Manufacturing and Commercialization of Licensed Products pursuant to this Agreement: a. discussing, reviewing and approving the Development Plans and amendments or modifications to the Development Plans;
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:
