Common use of JOC Responsibilities Clause in Contracts

JOC Responsibilities. The responsibilities of the JOC shall also include, but shall not be limited to: (a) making recommendations to the JSC with respect to target profiles for IL-1 Products (including key labeling claims required for commercial success of IL-1 Products given the competitive environment and any other key IL-1 Product features and benefits that would be used to develop or support a promotional message for IL-1 Products); (b) preparing, or overseeing the preparation of, Strategic Plans for IL-1 Products for the Co-Commercialization Countries for final approval by the JSC, and updating each such Plan not less frequently than once per Contract Year; (c) preparing, or overseeing the preparation of, Consolidated Co-Commercialization Plans (and related Consolidated Co-Commercialization Budgets) for the Co-Commercialization Countries in accordance with applicable Strategic Plans for final approval by the JSC, and updating each such Plan not less frequently than once per Contract Year; (d) preparing, or overseeing the preparation of, Consolidated Co-Development Plans (and related Consolidated Co-Development Budgets) for the Co-Commercialization Countries in accordance with applicable Strategic Plans for final approval by the JSC, and updating each such Plan not less frequently than once per Contract Year; (e) monitoring compliance with the Consolidated Co-Commercialization Plans and the Consolidated Co-Development Plans and, in connection therewith, reviewing and approving any material change in a Consolidated Co-Commercialization Plan or Consolidated Co-Development Plan, including, without limitation, specifically approving any change(s) in any line item or category of expenses in any Consolidated Co-Commercialization Budget or Consolidated Co-Development Budget which individually, or together with such previously approved changes in such line item or category, would result in a greater than five percent (5%) increase or decrease in the amount budgeted in such line item or category under either such Consolidated Co-Commercialization Budget or Consolidated Co-Development Budget, it being understood and agreed that expenditures by the Parties with respect to any matter included in a Consolidated Co-Commercialization Budget or Consolidated Co-Development Budget which individually or together with such prior expenditures, exceed by less than 5% the amount budgeted in any line item or category of expenses in such Consolidated Co-Commercialization Budget or Consolidated Co-Development Budget with respect to such matter shall not require approval by the JOC and for all purposes of this Agreement shall be deemed an expenditure in accordance with such Consolidated Co-Commercialization Budget or Consolidated Co-Development Budget, as applicable. (f) approving protocols for Clinical Trials of IL-1 Products in the applicable Territory, and monitoring and making modifications to such Clinical Trials; (g) reviewing and approving material regulatory correspondence, final study reports and submissions to Regulatory Authorities with respect to IL-1 Products; (h) facilitating an exchange between the Parties of data, information, material and results relating to the Development of IL-1 Products in the applicable Territory; (i) establishing and implementing procedures regarding the collection, sharing and reporting of adverse event information related to IL-1 Products in each country in the applicable Territory; (j) preparing and maintaining the overall plan for Commercialization of IL-1 Products in the Co-Commercialization Countries, defining joint planning and executing items, including, without limitation, timelines, IL-1 Product branding, positioning, core messages, tactical plans, staffing, Detailing, Alternate Marketing Channels, budgets and amendments thereto; (k) defining target groups to be covered by overall marketing efforts in the Co-Commercialization Countries, including, without limitation, key opinion leaders, physician groups, hospitals and regional buying groups, managed care organizations and governmental and government-affiliate buyers; (l) reviewing the Parties' respective marketing and promotional activities for consistency with the Consolidated Co-Commercialization Plan; (m) considering and selecting Product Trademarks for IL-1 Products for approval by the JSC; (n) establishing the contents, design and layout of packaging for each IL-1 Product, on a country-by-country basis where applicable; (o) developing and implementing plans and policies regarding journal and other publications with respect to IL-1 Products; (p) developing concepts for potential Phase IIIB and Phase IV Clinical Trials for IL-1 Products; (q) establishing as sub-committees of the JOC (collectively, the "Joint Sub-Committees"), a U.S. Joint Commercialization Sub-Committee, a Finance Sub-Committee and an Intellectual Property Sub-Committee, each of which: (i) shall be composed of an equal number of representatives of each Party, with the right to appoint the chairperson rotating between the Parties, and otherwise organized in such a manner as the JOC deems appropriate; (ii) shall be delegated such responsibilities as the JOC deems appropriate; and (iii) shall report to the JOC; (r) establishing, as and when necessary and/or appropriate, additional Joint Sub-Committees of the JOC such as a Joint Development Sub-Committee, a Joint Regulatory Sub-Committee, a Joint Commercialization Sub-Committee and/or Joint Country Commercialization Sub-Committees, which additional Joint Sub-Committees: (i) shall be composed of an equal number of representatives of each Party, with the right to appoint the chairperson rotating between the Parties, and otherwise organized in such a manner as the JOC deems appropriate; (ii) shall be delegated such responsibilities as the JOC deems appropriate; and (iii) shall report to the JOC; and (s) considering and acting upon such other matters as are specified in this Agreement or by the Joint Steering Committee.

JOC Responsibilities. The responsibilities of the JOC shall also include, but shall not be limited to: : (a) making recommendations to the JSC with respect to target profiles for IL-1 Products (including key labeling claims required for commercial success of IL-1 Products given the competitive environment and any other key IL-1 Product features and benefits that would be used to develop or support a promotional message for IL-1 Products); ; -23- <PAGE> (b) preparing, or overseeing the preparation of, Strategic Plans for IL-1 Products for the Co-Commercialization Countries for final approval by the JSC, and updating each such Plan not less frequently than once per Contract Year; ; (c) preparing, or overseeing the preparation of, Consolidated Co-Commercialization Plans (and related Consolidated Co-Commercialization Budgets) for the Co-Commercialization Countries in accordance with applicable Strategic Plans for final approval by the JSC, and updating each such Plan not less frequently than once per Contract Year; ; (d) preparing, or overseeing the preparation of, Consolidated Co-Development Plans (and related Consolidated Co-Development Budgets) for the Co-Commercialization Countries in accordance with applicable Strategic Plans for final approval by the JSC, and updating each such Plan not less frequently than once per Contract Year; ; (e) monitoring compliance with the Consolidated Co-Commercialization Plans and the Consolidated Co-Development Plans and, in connection therewith, reviewing and approving any material change in a Consolidated Co-Commercialization Plan or Consolidated Co-Development Plan, including, without limitation, specifically approving any change(s) in any line item or category of expenses in any Consolidated Co-Commercialization Budget or Consolidated Co-Development Budget which individually, or together with such previously approved changes in such line item or category, would result in a greater than five percent (5%) increase or decrease in the amount budgeted in such line item or category under either such Consolidated Co-Commercialization Budget or Consolidated Co-Development Budget, it being understood and agreed that expenditures by the Parties with respect to any matter included in a Consolidated Co-Commercialization Budget or Consolidated Co-Development Budget which individually or together with such prior expenditures, exceed by less than 5% the amount budgeted in any line item or category of expenses in such Consolidated Co-Commercialization Budget or Consolidated Co-Development Budget with respect to such matter shall not require approval by the JOC and for all purposes of this Agreement shall be deemed an expenditure in accordance with such Consolidated Co-Commercialization Budget or Consolidated Co-Development Budget, as applicable. . (f) approving protocols for Clinical Trials of IL-1 Products in the applicable Territory, and monitoring and making modifications to such Clinical Trials; ; (g) reviewing and approving material regulatory correspondence, final study reports and submissions to Regulatory Authorities with respect to IL-1 Products; ; (h) facilitating an exchange between the Parties of data, information, material and results relating to the Development of IL-1 Products in the applicable Territory; ; (i) establishing and implementing procedures regarding the collection, sharing and reporting of adverse event information related to IL-1 Products in each country in the applicable Territory; ; (j) preparing and maintaining the overall plan for Commercialization of IL-1 Products in the Co-Commercialization Countries, defining joint planning and executing items, including, without limitation, timelines, IL-1 Product branding, positioning, core -24- <PAGE> messages, tactical plans, staffing, Detailing, Alternate Marketing Channels, budgets and amendments thereto; ; (k) defining target groups to be covered by overall marketing efforts in the Co-Commercialization Countries, including, without limitation, key opinion leaders, physician groups, hospitals and regional buying groups, managed care organizations and governmental and government-affiliate buyers; ; (l) reviewing the Parties' respective marketing and promotional activities for consistency with the Consolidated Co-Commercialization Plan; ; (m) considering and selecting Product Trademarks for IL-1 Products for approval by the JSC; ; (n) establishing the contents, design and layout of packaging for each IL-1 Product, on a country-by-country basis where applicable; ; (o) developing and implementing plans and policies regarding journal and other publications with respect to IL-1 Products; ; (p) developing concepts for potential Phase IIIB and Phase IV Clinical Trials for IL-1 Products; ; (q) establishing as sub-committees of the JOC (collectively, the "Joint Sub-Committees"), a U.S. Joint Commercialization Sub-Committee, a Finance Sub-Committee and an Intellectual Property Sub-Committee, each of which: (i) shall be composed of an equal number of representatives of each Party, with the right to appoint the chairperson rotating between the Parties, and otherwise organized in such a manner as the JOC deems appropriate; (ii) shall be delegated such responsibilities as the JOC deems appropriate; and (iii) shall report to the JOC; ; (r) establishing, as and when necessary and/or appropriate, additional Joint Sub-Committees of the JOC such as a Joint Development Sub-Committee, a Joint Regulatory Sub-Committee, a Joint Commercialization Sub-Committee and/or Joint Country Commercialization Sub-Committees, which additional Joint Sub-Committees: (i) shall be composed of an equal number of representatives of each Party, with the right to appoint the chairperson rotating between the Parties, and otherwise organized in such a manner as the JOC deems appropriate; (ii) shall be delegated such responsibilities as the JOC deems appropriate; and (iii) shall report to the JOC; and and (s) considering and acting upon such other matters as are specified in this Agreement or by the Joint Steering Committee.. -25- <PAGE> 3.6