Formation; Purposes. Within thirty (30) days after the Effective Date, Aerpio and Licensee will establish a joint development committee (the “JDC”) composed of no more than three (3) representatives of each Party. The JDC will have responsibility for (i) reviewing and overseeing the overall progress of development and manufacturing activities under this Agreement with respect to Licensed Products for use in the Territory and in the Field, including oversight of the various budgets and activities, (ii) overseeing the implementation of all development operational aspects of the arrangements established by this Agreement, and (iii) forming various working group(s) (each, a “Working Group”) to oversee particular projects or activities from time to time and delegating to such Working Group(s) such operational responsibilities as the JDC may determine necessary or desirable. In conducting its activities, including in the allocation of activities to the Parties under each Development Plan, the JDC will operate and make its decisions consistent with the terms of this Agreement.
Formation; Purposes. Within ten (10) days after the Effective Date, the relevant Members shall establish the Boards contemplated by this Agreement and the Related Agreements which shall have overall responsibility for the management of the Companies. Without limiting the generality of the foregoing, the responsibilities of each respective Board shall include: approval of business plans, long range plans, annual sales and profit targets, and capital forecasts for each combination. The Boards shall carry out their responsibilities as set forth in this Agreement and the Related Agreements, as applicable, and shall have the authority to approve or disapprove any recommendation of the General Manager or any Committee under this Agreement and the Related Agreements, as applicable. With respect to matters not the subject of recommendation by any Committee or the General Manager under this Agreement or the Related Agreements, as applicable, no business may be transacted on behalf of a Company without the prior written consent or written authorization of the applicable Board. Without limiting the generality of the foregoing, only the applicable Board may authorize the expenditure of funds by or on behalf of a Company (unless specifically delegated to a Committee or the General Manager or pursuant to any plan approved by the Board of such Company or as otherwise set forth in Section 3.7). The Boards shall operate independently of the Members and all lawful determinations, decisions and actions made or taken by the applicable Board shall be conclusive and absolutely binding upon the applicable Company. Prior to establishment of the Boards, the Companies will be managed by the Members.
Formation; Purposes. Within forty-five (45) days after the Effective Date, M and S-P shall establish a worldwide oversight committee (the "WWOC"), which shall advise and provide guidance with respect to the Worldwide Cholesterol Business. The WWOC shall review and advise with respect to all worldwide strategic matters, including long range plans, long range sales and profit targets, supply shortage allocations and research matters that have an impact on the Worldwide Cholesterol Business.
Formation; Purposes. Within 45 days after the Effective Date, M and S-P shall establish an operating board (the "EMEA Operating Board"), which shall have overall responsibility for the management of the Cholesterol Products in the Field in the EMEA. Without limiting the generality of the foregoing, the responsibilities of the EMEA Operating Board shall be approving annual Marketing and Educational Plans and Five-Year Strategic Business Plans (each in the manner described in Section 3.2.4), capital forecasts and budgets (including costs of Phase V studies), as well as registration strategy and pricing/reimbursement strategy as proposed by the EMEA General Manager. The EMEA Operating Board shall carry out its responsibilities as set forth in this Agreement and the Related Agreements, as applicable, and shall have the authority to approve or disapprove any recommendation of the EMEA General Manager under this Agreement and the Related Agreements, as applicable. With respect to matters not the subject of recommendation by the EMEA General Manager under this Agreement or the Related Agreements, as applicable, no business may be transacted in the EMEA as contemplated by this Agreement and the Related Agreements without the prior written consent or written authorization of the EMEA Operating Board. The EMEA Operating Board shall operate with the intent of maximizing the commercialization of the Cholesterol Products in the Field in the EMEA. The Parties will seek to avoid unnecessary bureaucracy regarding the EMEA Operating Board and will seek to utilize the existing expertise within M and S-P. The EMEA Operating Board shall operate independently of M or S-P or their Affiliates and all lawful determinations, decisions and actions made or taken by the EMEA Operating Board shall be conclusive and absolutely binding with respect to the ECLAFE Cholesterol Business in the EMEA.
Formation; Purposes. Within [***] calendar days after the Effective Date, Arcellx and Kite shall establish a development working group (the “DWG”), which shall report to the JSC and have responsibility for (i) monitoring and facilitating the overall progress of Development activities under this Agreement with respect to Licensed Products in the Field, including oversight of the various budgets and activities, (ii) overseeing the implementation of all Development operational aspects of the collaboration established by this Agreement, (iii) forming Sub Group(s) from time to time and delegating to such Sub Group(s) such operational responsibilities as the DWG may determine necessary or desirable, and (iv) coordinating and providing oversight to any Sub Groups that report to the DWG. Accordingly, the DWG shall include equal member representation from both Arcellx and Kite that have sufficient development, regulatory, and technical operations experience. In conducting its activities, including in the allocation of activities to the Parties under the GDP for each Licensed Product, the DWG shall operate and make its decisions consistent with the terms of this Agreement.
Formation; Purposes. Within [***] calendar days after the Effective Date, Arcellx and Kite shall establish a commercialization working group (the “CWG”), which shall report to the JSC and have responsibility for (i) overseeing the Commercialization of Licensed Products in the U.S., (ii) providing a forum for discussing and exchanging information regarding the Commercialization of Licensed Products in the ExUS Territory, and (iii) forming Sub Group(s) from time to time and delegating to such Sub Group(s) such operational responsibilities as the CWG may from time to time determine necessary or desirable. The CWG shall include one (1) representative each of U.S. Marketing, Global Marketing, market access, analytics and commercial operations, Medical Affairs from each Arcellx and Kite. In conducting its activities, the CWG shall operate and make its decisions consistent with the terms of this Agreement.
Formation; Purposes. DURATION -----------------------------
Formation; Purposes. Within ninety (90) days after the Implementation Date, Nogra and Licensee will establish a joint commercialization committee (the “JCC”), which will report to the JSC and have responsibility for (i) overseeing the implementation of all Commercialization operational aspects of the collaboration established by this Agreement and (ii) forming Working Group(s) from time to time and delegating to such Working Group(s) such operational responsibilities as the JCC may from time to time determine necessary or desirable. The JCC will include an equal number of designated compliance officers from both Nogra and Licensee to advise the JCC on compliance with relevant Laws and policies. In conducting its activities, including the allocation of activities to the Parties under the Commercialization Plan, the JCC will operate and make its decisions consistent with the terms of this Agreement.
Formation; Purposes. Quintiles Commercial and Alimera shall establish a Joint Steering Committee (“JSC”). The JSC shall have overall strategic responsibility for managing the relationship established by this Agreement. In overseeing the operational aspects of commercialisation, the JSC shall, without limitation and in addition to other specific obligations set forth in this Agreement and the Project Orders: (i) discuss and agree upon the mission and vision for the relationship between the Parties and ensure that such mutually agreed upon mission and vision are carried out, (ii) maintain senior level focus, (iii) review business performance, including, without limitation, ****, (iv) **** **** CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. ****, (v) ensure that Alimera has access to Quintiles Commercial knowledge and experience with respect to ****, as appropriate, (vi) coordinate training activities for the Quintiles Commercial personnel deployed in each Territory, (vii) ****, (viii) facilitate the flow of information between the Parties for the betterment of the Services to be provided under each Project Order, and (ix) act as an escalation forum for unresolved operational issues. In addition to ensuring the effective implementation of this Agreement and the Project Orders entered into hereunder, the JSC shall have initial responsibility for resolving disputes between the Parties. Other key issues to be discussed by and within each quarterly meeting of the JSC (referred to at Clause 1.4.3 below) shall include, without limitation: ****
Formation; Purposes. Within [*****] after the Effective Date, Cxxxxxxx and Taiho shall establish a joint development committee (the “JDC”), which shall report to the JSC and have responsibility for (i) monitoring and facilitating the overall progress of Development activities under this Agreement with respect to the Collaboration Products in the Field in support of the Core Dossier, including oversight of the various budgets (including the Development Budget) and activities, (ii) providing a forum for Taiho to keep Cxxxxxxx reasonably informed as to other Development activities with respect the Collaboration Products, and (iii) forming and overseeing additional Working Group(s) from time to time and delegating to such Working Group(s) such operational responsibilities as the JDC may determine necessary or desirable. In conducting its activities, including in the allocation of activities to the Parties under the GDP, the JDC shall operate and make its decisions consistent with the terms of this Agreement.
