Common use of Joint Commercialization Committee Clause in Contracts

Joint Commercialization Committee. Within [**] after the Effective Date, the Parties shall establish a joint commercialization committee (the “Joint Commercialization Committee” or “JCC”), which shall include appropriate representation of each Party (which such representation need not be equal), and each representative shall possess the requisite experience and seniority to enable such person to make decisions on behalf of the applicable Party with respect to the issues falling within the jurisdiction of the JCC. From time to time, each Party may substitute one or more of its representatives to the JCC on written notice to the other Party. Sanofi shall select from its representatives the chairperson for the JCC, which chairperson may be changed from time to time, on written notice to Lexicon. The JCC shall: 5.4.1. periodically serve as a forum for discussing Commercialization of the Licensed Products in the Territory and Medical Affairs Activities in the Territory hereunder or the (Co-)Promotion Agreement, including the coordination of strategies for Commercialization activities and Medical Affairs Activities across the T1DM and T2DM indications; 5.4.2. coordinate the activities of the Parties under the Commercialization Plans and oversee the implementation of the Commercialization Plans; 5.4.3. review and discuss the Commercialization Plans and amendments thereto in accordance with Section 4.3; 5.4.4. facilitate the flow of information with respect to Commercialization activities and Medical Affairs Activities with respect to the Licensed Product in the Territory; 5.4.5. review reports related to Commercialization Costs and Medical Affairs Costs as provided in Section 7.7 and identify any concerns to the JSC; and 5.4.6. perform such other functions as are set forth herein, or in any Ancillary Agreement, or if and as applicable, as the Parties may mutually agree in writing or as directed by the JSC, except where in conflict with any provision of this Agreement or any Ancillary Agreements.

Joint Commercialization Committee. Within [****] after the Effective Date, the Parties shall establish a joint commercialization committee (the “Joint Commercialization Committee” or “JCC”), which shall include appropriate representation consist of [****] representatives from each Party (which such representation need not be equal)of the Parties, and each representative shall possess with the requisite experience and seniority to enable such person to make decisions on behalf of the applicable Party Parties with respect to the issues falling within the jurisdiction of the JCC. From time to time, each Party may substitute one or more [****] of its representatives to the JCC on upon written notice to the other Party. Sanofi [****] shall select from appoint [****] of its representatives the to serve as a co-chairperson for of the JCC, which and [****] may change its appointed co-chairperson may be changed from time to time, on time upon written notice to Lexicon[****]. The JCC shall: 5.4.1. periodically 7.2.1 discuss the Global Commercialization Strategy prepared by PARTNER and submitted in accordance with Section 4.2.1; 7.2.2 serve as a forum for discussing and coordinating the Commercialization of the Licensed Products in the Territory Licensed Field in the United States as set forth in Section 4.3; 7.2.3 discuss, together with the JMC, the timing for commencement of Manufacturing and Medical Affairs Activities supply of Commercial Supply and commercial Process Development in the Territory hereunder or and serve as a forum for discussing and coordinating the (Co-)Promotion Agreement, including the coordination of strategies for Commercialization activities Manufacturing and Medical Affairs Activities across the T1DM and T2DM indicationssupply as set forth in Section 5.2.1; 5.4.2. coordinate the activities of the Parties under 7.2.4 develop the Commercialization Plans and oversee the implementation of Budgets therefor for Licensed Products for use in the Licensed Field in the United States and any amendments thereto as set forth in Section 4.2.2 or, if applicable, 4.5.2; 7.2.5 discuss and determine Commercialization activities under the Commercialization PlansPlan for which REGENX is responsible; 5.4.3. 7.2.6 [****]; 7.2.7 [****]; 7.2.8 with respect to the Commercialization of Licensed Products for use in the Licensed Field in the United States, review and discuss the Commercialization Plans costs and amendments thereto expenses incurred by the Parties in accordance connection with Section 4.3; 5.4.4. facilitate the flow of information with respect to such Commercialization, including against Budgets set forth in Commercialization activities and Medical Affairs Activities with respect to the Licensed Product in the Territory; 5.4.5. review reports related to Commercialization Costs and Medical Affairs Costs as provided in Section 7.7 and identify any concerns to the JSCPlans; and 5.4.6. 7.2.9 perform such other functions as are set forth herein, herein or in any Ancillary Agreement, or if and as applicable, as the Parties may mutually agree in writing or as directed by the JSCwriting, except where in conflict with any provision of this Agreement or any Ancillary AgreementsAgreement.

Joint Commercialization Committee. Within [**] after the Effective Date, the The Parties shall establish a joint commercialization committee Joint Commercialization Committee (the “Joint Commercialization Committee” or “JCC”), which shall include appropriate representation of each Party ) to (which such representation need not be equal), a) develop and each representative shall possess the requisite experience and seniority to enable such person to make decisions oversee strategies on behalf of the applicable Party with respect to the issues falling within the jurisdiction of the JCC. From time to time, each Party may substitute one or more of its representatives to the JCC on written notice to the other Party. Sanofi shall select from its representatives the chairperson a global level for the JCC, which chairperson may be changed from time to time, on written notice to Lexicon. The JCC shall: 5.4.1. periodically serve as a forum for discussing Commercialization of the Licensed Products Product in the Territory and Medical Affairs Activities in the Territory hereunder or the (Co-)Promotion AgreementTerritory, including the coordination of reviewing and overseeing Packaging and Labeling and establishing global pricing guidelines, and marketing and patient access programs and strategies for Commercialization activities and Medical Affairs Activities across the T1DM and T2DM indications; 5.4.2. coordinate the activities of the Parties under the Commercialization Plans Product, (b) establish and oversee the implementation of a Global Commercialization Plan and, if the Commercialization Plans; 5.4.3. JCC so elects, review and discuss the oversee any Annual Regional Commercialization Plans and amendments thereto in accordance with Section 4.3; 5.4.4. facilitate 9.1.1, and oversee the flow of information with respect to Commercialization activities Activities under the collaboration, in each case ((a) and Medical Affairs Activities with respect to the Licensed Product in the Territory; 5.4.5. review reports related to Commercialization Costs and Medical Affairs Costs as provided in Section 7.7 and identify any concerns to the JSC; (b)), on a global and 5.4.6. perform such other functions as are set forth herein, or in any Ancillary Agreement, or if and as applicable, as on a Commercialization Region basis, and (c) establish and, if appropriate, amend guidance for the appropriate Packaging Configuration that may be used by either Commercialization Party, provided that the Parties acknowledge and agree that [***]. The JCC shall be composed of [***] senior executives of each Party; provided that the total number of representatives may mutually be changed upon mutual agreement of the Parties (so long as each Party has an equal number of representatives). One representative of each party on the JCC shall be designated by such Party to be a co-chairperson of the JCC. As part of its responsibilities, but subject to the decision making processes at Section 6.5.4 in the event agreement cannot be reached, the JCC shall also perform the following: 6.4.1.1 Within each annual planning cycle, the JCC shall discuss and seek to agree on the forward-looking Gross Profit budget for the following year to be set forth in writing the applicable Global Commercialization Plan by reference to the following year’s profit and loss forecast [***]. Relevant items for such review and discussion shall include: [***]. Each Party shall promptly notify the JCC if it becomes aware that there is a deviation in the immediately preceding Pfizer Quarter of more than [***] of the actual Gross Profit as compared against the budget for the Gross Profit in the profit and loss forecasts pursuant to the above (a “Budget Deviation”) and specify the reason for such Budget Deviation. Following such Budget Deviation notice, the JCC shall discuss the reasons for such deviation on a Relevant Line Item by Relevant Line Item basis and seek to agree on any potential measures to be taken to address and improve the situation. In addition, from [***] onwards, the Parties shall review, each Pfizer Quarter, the profit and loss statement compared to the Gross Profit level pursuant to (i) and (ii) above for such Pfizer Quarter and such year-to-date against the equivalent Pfizer Quarter in the previous year and the equivalent year-to-date period in the previous year. 6.4.1.2 The JCC shall review, discuss and agree by mutual consent all aspects relating to Product Components in any market or as directed by the JSCregion, except where in conflict with any provision of this Agreement or any Ancillary Agreementsincluding [***].

Joint Commercialization Committee. Within [**] after The Parties recognize that it is in both of their interests to (i) maximize the Effective Datesales of the Licensed Product in the Territory; (ii) maximize the marketing of the Licensed Product in the Territory during the term of the Agreement; and (iii) to coordinate the activities of both Parties with respect to the promotion of the Licensed Product in the Territory. 4.2.1 Accordingly, the Parties shall hereby establish a joint commercialization committee made up of an equal number of representatives of each Party set forth in Schedule B hereto (the “Joint Commercialization Committee” or “JCC”). Both Parties shall have the right from time to time to substitute individuals, which shall include appropriate representation on a permanent or temporary basis, for any of its previously designated members of the JCC. The members appointed by each Party shall be vested with appropriate decision-making authority and power by such Party. Either Party shall have the right to engage Third Parties to assist as members of the JDC, provided, however, (which such representation need not be equal), i) said Third Party agrees to protect the confidential information of both Parties consistent with the terms and each representative shall possess the requisite experience provisions of Section 10; and seniority to enable such person to make decisions on behalf of (ii) the applicable Party obtains the prior written approval of the other Party of said Third Party, such approval not to be unreasonably withheld or delayed. 4.2.2 The JCC shall meet: (i) once every six months after filing of the NDA by Licensee, or more often as needed, on a date and at a location to be agreed to by the JCC, and (ii) upon written notice by either Party to the other that a meeting is required or requested, in which case a meeting will be held within fourteen (14) calendar days of such notice on a date and at a location to be agreed to by the Parties. Notice requesting a meeting shall include adequate information describing the activity to be reviewed. Any meetings of the JCC may be held in person at a location to be agreed to by the Parties, or by videoconference or teleconference. Other representatives of the Parties may attend JCC meetings as participants. The Parties shall agree, at the first meeting of the JCC, upon procedures for maintaining meeting minutes. 4.2.3 The purpose of the JCC is to serve as an advisory committee to make recommendations and to coordinate the marketing and promotional efforts of the Parties with respect to the issues falling within the jurisdiction promotional effort of the JCC. From time to time, each Party may substitute one or more of its representatives to the JCC on written notice to the other Party. Sanofi shall select from its representatives the chairperson for the JCC, which chairperson may be changed from time to time, on written notice to Lexicon. The JCC shall: 5.4.1. periodically serve as a forum for discussing Commercialization of the Licensed Products in the Territory and Medical Affairs Activities in the Territory hereunder or the (Co-)Promotion Agreement, including the coordination of strategies for Commercialization activities and Medical Affairs Activities across the T1DM and T2DM indications; 5.4.2. coordinate the activities of the Parties under the Commercialization Plans and oversee the implementation of the Commercialization Plans; 5.4.3. review and discuss the Commercialization Plans and amendments thereto in accordance with Section 4.3; 5.4.4. facilitate the flow of information with respect to Commercialization activities and Medical Affairs Activities with respect to the Licensed Product in the TerritoryTerritory and to maximize the sales thereof. Accordingly, the JCC shall discuss and resolve, to the extent possible, any issues that arise under this Agreement including, without limitation, the following: (a) Review of the Licensee’s annual detailed marketing plan for the Licensed Product, including product and appropriate sales force training; 5.4.5. review reports related (b) Determining the reasonable quantities of Licensed Product samples to Commercialization Costs and Medical Affairs Costs as be provided by Licensee for use in Section 7.7 and identify any concerns to the JSCTerritory; and 5.4.6(c) Determining the schedule of delivery of Licensed Product samples and promotional sales, marketing, and educational materials for the Licensed Product to Licensee’s sales representatives and to physicians called upon by Licensee’s sales force. 4.2.4 In the event of a JCC dispute that cannot be otherwise resolved, Licensee’s President shall have final authority. perform such other functions as are set forth hereinThat authority may be exercised in Licensee’s President’s discretion, or in any Ancillary Agreement, or if and as applicable, as provided it is consistent with the Parties may mutually agree in writing or as directed by the JSC, except where in conflict with any provision terms of this Agreement or any Ancillary Agreements.Agreement