Common use of Joint Commercialization Committee Clause in Contracts

Joint Commercialization Committee. (a) Within thirty (30) days after the Effective Date, the parties shall form a Joint Commercialization Committee (“JCC”) to focus on and manage the Commercialization of the Products for the Initial Indications and, if applicable, Additional Indications and/or New Formulations agreed upon in the Commercialization Plan in the Initial Territory. The JCC shall be composed of two (2) management representatives appointed by each Party (Such representatives may be management representatives of each Party’s Affiliates.), with the chairman from Takeda. All decisions of the JCC shall be unanimous. (b) The JCC shall meet, at a minimum, on a quarterly basis, at a location(s) agreed upon by the JCC or by telephone or video conference, provided that any decision made during a meeting is evidenced in a writing signed by one of the members of the JCC from each of the Parties. Each Party shall bear the travel and living expenses of its own personnel to attend any such meetings. The JCC will keep minutes reflecting actions taken at meetings. (c) The JCC responsibilities will include (i) developing, managing and overseeing the Commercialization Plan and strategy for the Products for the Initial Indications and, if applicable, Additional Indications and/or New Formulations, agreed upon in the Commercialization Plan, in the Initial Territory, (ii) approving Phase IV Studies for marketing purposes for the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory, (iii) managing and overseeing Commercialization budgets for the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory, (iv) checking the status of planned activities, (v) determining go/no-go of Labeling Change(s), Additional Indication(s) and New Formulation(s) of the Products in the Initial Territory and (vi) discussing and coordinating the arrangement of and facilitating the collaboration and coordination between the parties during the co-promotion period. In addition, the JCC shall set the number of sales representatives and product positioning for the Products for the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory.

Appears in 2 contracts

Samples: Collaboration and License Agreement (Sucampo Pharmaceuticals, Inc.), Collaboration and License Agreement (Sucampo Pharmaceuticals, Inc.)

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Joint Commercialization Committee. 3.1.1 Within sixty (a) Within thirty (3060) days after the Effective Date, Date the parties Parties shall form establish a Joint Commercialization Committee (“JCC”) ), which shall provide a forum for open communication between the Parties regarding Product Commercialization activities, and which shall be responsible for such matters related to focus on and manage the Commercialization of the Products for the Initial Indications and, if applicable, Additional Indications and/or New Formulations agreed upon in the Commercialization Plan in the Initial TerritoryTerritory as may be described below. The JCC shall be composed consist of two (2) management representatives appointed by each Party (Such representatives may be management representatives of each Party’s Affiliates.), with the chairman from Takeda. All decisions of the JCC shall be unanimous. (b) The JCC shall meet, at a minimum, on a quarterly basis, at a location(s) agreed upon by the JCC or by telephone or video conference, provided that any decision made during a meeting is evidenced in a writing signed by one of the members of the JCC individuals from each of the Parties. Each Party shall bear have the travel right at any time and living expenses from time to time to designate a replacement, on a permanent or temporary basis, for any or all of its own personnel previously-designated members of the JCC. CPI shall appoint one of its designees to attend any such meetingsserve as the Chair of the JCC. The JCC will keep shall meet at least once per Calendar Quarter, and more frequently as mutually agreed by the Parties, on such dates and at such places and times as the Parties shall agree. The Party hosting any JCC meeting shall appoint one person (who need not be a member of the JCC) to attend the meeting and record the minutes reflecting actions taken at meetingsof the meeting in writing. Such minutes shall be circulated to the members of the JCC in a time frame to be agreed upon by the JCC after the meeting and the members agree to review and comment on such minutes in a time frame to be agreed upon by the JCC. The Parties agree to use Commercially Reasonable Efforts to promptly finalize any dispute regarding minutes of any meeting. 3.1.2 CPI agrees to keep the JCC reasonably informed in respect of its Commercialization of the Product in the Territory pursuant to its authority and responsibility set forth in Section 5.1, and in particular CPI shall: (a) provide the JCC with copies of CPI’s annual Product marketing plans on a quarterly basis, information regarding CPI’s Commercialization strategy, and updates regarding the foregoing and the progress of CPI’s Commercialization activities; (b) promptly advise the JCC of any unforeseen material problems or delays encountered since the date of its last report in connection with the Commercialization activities; and (c) provide GEL as soon as reasonably practicable with such other documentation and information as GEL’s JCC members may reasonably request in writing from time to time with respect to the status of the Commercialization activities and progress. CPI will reasonably and in good faith consider any comments and recommendations provided pursuant to this Section that the JCC may have with respect to the Commercialization of the Product. 3.1.3 The JCC responsibilities will include shall: (ia) developingreview and make recommendations (or decline to make recommendations), managing and overseeing regarding the overall progress of the Commercialization Plan of the Product, managed care strategy and strategy for managed care access regarding the Products for Product; and (b) perform such other activities and discharge such other responsibilities as may be assigned to the Initial Indications and, if applicable, Additional Indications and/or New Formulations, JCC by the Parties pursuant to this Agreement or as may be mutually agreed upon in writing by the Parties from time to time. CPI will reasonably and in good faith consider any comments and recommendations that the JCC may have pursuant to this Section with respect to the Commercialization Plan, of the Product. 3.1.4 The JCC shall establish the initial WAC and AWP for the Product based on information provided by CPI. CPI shall not make changes to the WAC or the AWP without consulting with and receiving approval of the JCC. CPI shall have the discretion to apply discounts to AWP in the Initial Territory, (ii) approving Phase IV Studies for marketing purposes for ordinary course of business; provided that these discounts will be reviewed periodically by the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory, (iii) managing and overseeing Commercialization budgets for the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory, (iv) checking the status JCC. 3.1.5 The JCC has no decision-making authority except as expressly set forth herein. All decisions of planned activities, (v) determining go/no-go of Labeling Change(s), Additional Indication(s) and New Formulation(s) of the Products in the Initial Territory and (vi) discussing and coordinating the arrangement of and facilitating the collaboration and coordination between the parties during the co-promotion period. In addition, the JCC shall set be made by unanimous vote or unanimous written consent of both Parties, with each Party having, collectively among its respective designees, one vote in all decisions. The members of the number JCC shall use Commercially Reasonable Efforts to decide all matters assigned to the JCC under this Agreement or otherwise referred to it by mutual written agreement of sales representatives the Parties; provided, however, that if the members of the JCC are unable to make a decision by unanimous vote or unanimous written consent within ten (10) days after commencing discussions regarding such decision, then, any JCC member may submit it to the Executive Officers of the Parties for resolution. Each Party shall designate an “Executive Officer” of its company as the designee in the event of any dispute that has not been resolved by the JCC in accordance with this Section. The Executive Officer must be at least at the level of an officer of the respective Party. The Executive Officers of the Parties shall discuss in good faith the issue to be resolved and product positioning make a decision based on an assessment of the objectives for the Products for Commercialization of the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial TerritoryProduct.

Appears in 1 contract

Samples: License and Supply Agreement (Cumberland Pharmaceuticals Inc)

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Joint Commercialization Committee. (ai) Within The JCC shall oversee Commercialization of JAK Licensed Products in the Field worldwide. As soon as practicable following the Effective Date (but in no event more than thirty (30) days after following the Effective Date), each Party shall designate its initial three (3) representatives on the parties shall form a Joint Commercialization Committee (“JCC”) to focus on and manage the Commercialization of the Products for the Initial Indications and, if applicable, Additional Indications and/or New Formulations agreed upon in the Commercialization Plan in the Initial Territory. The JCC shall be composed of two appropriate and key executives of Novartis together with an equal number of appropriate and key executives from Incyte. Novartis and Incyte shall each appoint a person from among its representatives on the JCC to serve as the co-chairperson of the JCC. The co-chairpersons shall not have any greater authority than any other representative on the JCC and shall conduct the following activities of the JCC: (2A) management representatives appointed by each Party calling meetings of the JCC; (Such representatives may be management representatives B) preparing and issuing minutes of each Party’s Affiliates.), with such meeting within thirty (30) days thereafter; (C) preparing and circulating an agenda for the chairman from Takeda. All decisions of upcoming meeting; and (D) ensuring that any decision-making delegated to the JCC shall be unanimousis carried out in accordance with Section 3.5. (bii) The JCC shall meetbe responsible for: (A) overseeing, at reviewing and coordinating the Commercialization of JAK Licensed Products in the Field worldwide; (B) developing and overseeing the Global Branding Strategy; (C) setting overall strategic objectives and plans related to Commercialization of JAK Licensed Products in the Field worldwide; (D) reviewing, commenting on and approving the Promotional Plan; (E) reviewing Commercialization issues for JAK Licensed Products in the Field in the Novartis Territory that will have an impact on Commercialization of JAK Licensed Products in the Field in the Incyte Territory; (F) reviewing Commercialization issues for JAK Licensed Products in the Field in the Incyte Territory that will have an impact on Commercialization of JAK Licensed Products in the Field in the Novartis Territory; (G) providing a minimum, on a quarterly basis, at a location(sforum for the Parties to discuss the Commercialization of JAK Licensed Products in the Field worldwide; and (H) such other responsibilities as may be assigned to the JCC pursuant to this Agreement or as may be mutually agreed upon by the JCC or by telephone or video conference, provided that any decision made during a meeting is evidenced in a writing signed by one of the members of the JCC Parties from each of the Parties. Each Party shall bear the travel and living expenses of its own personnel time to attend any such meetings. The JCC will keep minutes reflecting actions taken at meetingstime. (c) The JCC responsibilities will include (i) developing, managing and overseeing the Commercialization Plan and strategy for the Products for the Initial Indications and, if applicable, Additional Indications and/or New Formulations, agreed upon in the Commercialization Plan, in the Initial Territory, (ii) approving Phase IV Studies for marketing purposes for the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory, (iii) managing and overseeing Commercialization budgets for the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory, (iv) checking the status of planned activities, (v) determining go/no-go of Labeling Change(s), Additional Indication(s) and New Formulation(s) of the Products in the Initial Territory and (vi) discussing and coordinating the arrangement of and facilitating the collaboration and coordination between the parties during the co-promotion period. In addition, the JCC shall set the number of sales representatives and product positioning for the Products for the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory.

Appears in 1 contract

Samples: Collaboration and License Agreement (Incyte Corp)

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