Joint Commercialization Committee. As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:
(a) review and recommend the Commercialization Plans and related activities with respect to the Commercialization of Products in the Collaborator Territory, and report to the JEC on all significant Commercialization activities in the Collaborator Territory;
(b) provide a forum for and facilitate communications and coordination between the Parties with respect to the Commercialization of Products in the Collaborator Territory and the Exelixis Territory;
(c) on an annual basis, discuss and establish Collaborator’s Minimum Commercial Performance thresholds pursuant to Section 6.3(b) and propose recommendation to JEC; [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(d) review the status of material Product manufacturing and supply activities and strategies associated with Commercialization;
(e) review and discuss the major findings of Collaborator’s market research with respect to any Product in the Collaborator Territory, if any;
(f) review and oversee the branding and product positioning strategy for Products in the Collaborator Territory and evaluate Collaborator’s brand strategy for the Product in the Collaborator Territory for consistency with the then-current global brand strategy for the Product;
(g) discuss Product list price and status of reimbursement in the Collaborator Territory; and
(h) perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Commercialization of Products, including endeavoring to resolve any disputes between the Parties arising from the deliberations of the JCC, or as otherwise directed by the JEC.
Joint Commercialization Committee. Upon a decision by the JSC to activate the joint Commercialization committee, but in no case later than eighteen (18) months prior to the projected First Commercial Sale (the “Joint Commercialization Committee” or “JCC”), the Parties shall establish the JCC. The JCC shall hold its initial meeting within thirty (30) days of its establishment. Following its initial meeting, the JCC will meet in person, by teleconference or by video-teleconference at least [***] per [***] to review and discuss material decisions and key activities that relate to the matters set forth below. The JCC will be responsible for the communication, review and discussion of the Commercialization Plan and other Commercialization matters, including marketing strategy and planning, pricing, commercial manufacture, and [***], in each case in the Territory. Without limiting the foregoing, the JCC shall be responsible for: (a) reviewing and consulting with Coherus on the Commercialization Plan prior to adoption of the Commercialization Plan or changes by Licensee; (b) recommending the Commercialization Plan for approval by the JSC prior to adoption of the Commercialization Plan; (c) communicating with the JDC regarding the interrelationship between Development activities and potential Commercialization activities; (d) reviewing and monitoring the activities and progress against the Commercialization Plan; (e) monitoring and reporting on the competitive landscape for the Product in the Territory; (f) establishing appropriate processes for coordinating review of promotional materials for the Territory to ensure compliance with Applicable Laws and industry best practices; (g) overseeing the trademark and publication strategies for the Territory; and (h) communicating with the Parties regarding all of the foregoing.
Joint Commercialization Committee. Promptly after the Effective Date, the Parties shall establish a Joint Commercialization Committee (the “Joint Commercialization Committee” or “JCC”). The JCC shall be led by co-chairs, one of which shall be selected by Vertex and one of which shall be selected by Xxxxxxx.
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. (a) In the event that Intellikine exercises its Oncology Product Option in accordance with Section 7.1, the Parties will establish a Joint Commercialization Committee for Shared Product(s) within thirty (30) days following the first exercise by Intellikine of its Oncology Product Option. The JCC shall be composed of three (3) representatives from Intellikine and three (3) representatives from Infinity. The JCC members shall be appropriately qualified and experienced in order to make a meaningful contribution to committee meetings. Each Party may replace its representatives on the JCC on written notice to the other Party.
(b) The JCC shall have responsibility for (i) the general oversight and coordination of all commercialization activities with respect to such Shared Product in the United States, including pre-Launch, Launch and sales and marketing activities under the Commercial Plan, and (ii) following Intellikine’s exercise of the Oncology Product Option with respect to a Shared Product, approval (subject to Section 1.4 of Exhibit 5) of the Commercial Plan (including budgets) and any amendment thereto for such Shared Product. Each Party may from time to time invite a reasonable number of participants, in addition to its representatives on the XXX, xx xxxxxx XXX meetings in a non-voting capacity, provided that such participants are subject to the confidentiality provisions set forth in Article 12. The JCC will be chaired by a representative from Infinity. The chairperson shall set agendas for JCC meetings in advance, provided that the agendas will include any matter requested by either Party. The chairperson shall be responsible for recording, preparing and, within a reasonable time, issuing draft minutes of each JCC meeting.
(c) The JCC will meet at least quarterly and at such other times as requested by the chairperson or as the Parties may otherwise agree. Meetings shall be held at such place or places as are mutually agreed or by teleconference or videoconference; provided, however, that there shall be at least two (2) face-to-face meetings per calendar year.
(d) Decisions of the JCC shall be made by unanimous vote, with Infinity’s representatives to the JCC collectively having one (1) vote and Intellikine’s representatives to the JCC collectively having one (1) vote. If the JCC fails to reach unanimous agreement on a matter before it for decision for a period in excess of thirty (30) days, such matter shall be resolved in accordance with Section 4.7...
Joint Commercialization Committee. Promptly following the Effective Date, a joint commercialization committee (the “Committee”) will be formed consisting of an equal number of representatives, such number to be mutually agreed by the parties, from each of Client, CHS, and Cardinal Health. Each party may replace any of its representatives at any time, and from time to time, by giving written notice to the other party. The Committee will be chaired by a Client representative, and the Committee will meet at such locations as reasonably determined by the chair to discuss and coordinate the overall marketing and sales strategy for the Product, relevant Workplans and Budgets therein associated with the Product, and any other relevant topics relating to the commercialization of the Product. The Committee will convene at least four (4) times annually or more frequently as the parties deem necessary and meetings may be held by audio or video teleconference, with the consent of each party; provided that at least one (1) meeting per calendar year shall be held in person. The parties agree that the purpose of the Committee is solely to provide a forum for the parties to discuss, monitor and coordinate activities and communications relating to the performance of the Services and provide recommendations relating thereto to the parties. The Committee does not have the authority to approve or modify Workplans or Budgets, or to amend this Agreement.
Joint Commercialization Committee. The JCC shall be established by the parties and shall be comprised of eight members, four of whom shall be appointed by Depomed and four of whom shall be appointed by King. Each party’s respective initial appointments to the JCC are set forth on Schedule 3.2 hereto. A party may change any of its representatives at any time if a new person is appointed to any of the foregoing positions by giving written notice to the other party. The total number of JCC members may be changed by unanimous vote of the JCC from time to time as appropriate; provided, that the JCC shall in all cases be comprised of an equal number of members from each of Depomed and King. King and Depomed each will designate one representative of such party to serve as co-chairs of the JCC (the “Co-Chairs”). The members appointed to the JCC by each party shall be employees of such party and shall be vested with appropriate decision-making authority and power by such party. The Chief Executive Officers of King and Depomed, the Chief Operating Officer of Depomed, and the Chief Commercial Officer of King shall not be members of the JCC.
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.
Joint Commercialization Committee. (a) Within thirty (30) days of the Original Effective Date, the Parties will establish the Joint Commercialization Committee. When established, the JCC shall be composed of two representatives appointed by each of IDEC and Genentech. Either Party may replace any or all of its representatives at any time upon prior written notice to the other Party. The JCC will be an operational committee made up of individuals with expertise and responsibilities in the areas of product development and marketing, sales management or market research. The JCC will meet on a quarterly basis, except that from submission of a BLA for a Franchise Product in the Co-Promotion Territory until the end of the second year of sales for such Franchise Product in the Co-Promotion Territory, the JCC shall meet more frequently in order to prepare for and oversee the launch of such Franchise Product. The JCC will operate by consensus, except as expressly set forth herein. Each representative will have one vote. If the JCC is unable to resolve a dispute regarding any issue presented to it, such dispute shall be resolved in accordance with Section 17.1.
(b) The purposes of the JCC shall be to (i) monitor, review and approve commercialization plans with regard to the commercialization of Franchise Products in the Co-Promotion Territory, including, in accordance with Section 5.4, top-line annual marketing and sales budgets (as described in Section A.1(a) of Exhibit A), annual forecasts of sales and production requirements, the annual marketing plan, broad product positioning, initial product pricing, and Phase IV clinical strategy (e.g. overall plans for investigator sponsored trials and publication studies) as well as (ii) select trademarks for Franchise Products.
(c) The JCC shall have no involvement in the commercialization of Licensed Products in the Licensed Territory, which shall be solely the responsibility of Genentech at its expense.
(d) The term of the JCC will be determined by the Management Committee.
Joint Commercialization Committee. The Parties shall establish a Joint Commercialization Committee (“JCC”) promptly following the Closing. The JCC shall oversee (i) commercialization of Licensed Products in the Territory during the License Term and (ii) operation of the JDC and its subcommittees. Each Party’s designated co-chair of the JDC shall be a member of the JCC by virtue of such position on the JDC. Each Party shall appoint two (2) additional members to the JCC, with each Party designating one of its representatives as a co-chair of the JCC. The JDC and its sales and marketing subcommittee shall report directly to the JCC.
