Development and Commercialization Committees Clause Samples

The "Development and Commercialization Committees" clause establishes formal committees responsible for overseeing and coordinating the development and commercialization activities related to a product or project under the agreement. These committees typically consist of representatives from each party and are tasked with making joint decisions on key matters such as project milestones, budgets, timelines, and marketing strategies. By providing a structured forum for collaboration and decision-making, this clause ensures that both parties remain aligned and can efficiently address issues, thereby reducing misunderstandings and facilitating the successful advancement and commercialization of the product.
Development and Commercialization Committees. 2.1. DEVELOPMENT COMMITTEE Within ten (10) days after the Effective Date, ELITE and IPC shall establish a Development Committee (the "D-Committee") comprised of not less than two, and not more than three, persons ("Representatives") selected by each Party. ELITE and IPC shall each designate an equal number of Representatives to the D-Committee, with each Party having the right to increase the number of Representatives at any time to the maximum of three upon written notice to the other Party; provided, however, in any event, IPC and ELITE shall retain an equal number of Representatives on the Committee and equal voting rights. The D-Committee shall carry out the duties set forth below in Section 2.4. 2.2. The first meeting of the D-Committee shall be held within fifteen (15) days from the Effective Date, at which time the procedures of the D-Committee may be established. Thereafter, the D-Committee shall meet on such schedule as deemed appropriate by the Representatives, but not less frequently than each calendar quarter, with any one Representative being empowered to call a meeting of the D-Committee upon at least five (5) days' notice (which notice shall include a detailed description of all matters to come before the D-Committee at such meeting for consideration or action). 2.3. At meetings, each Party shall have the right to provide information for consideration and the D-Committee shall consider all such input. All decisions by the D-Committee shall be made by unanimous vote of its Representatives. For greater certainty, a vote is unanimous if, and only if, all of the Parties' Representatives in actual attendance at any such meeting, irrespective of the Party they represent, vote for the same outcome of any decision to be taken. A quorum required for any action by the D-Committee shall consist of at least one ELITE Representative and one IPC Representative. Participation at a meeting may be in person, by telephone conference call or by video conference, so long as all participants can hear and be heard by one another at all times throughout the meeting. If the meeting is in person, it shall be held alternately at ELITE's and IPC's offices, unless otherwise agreed by the Representatives. All Representatives serving on the D-Committee not in attendance shall be notified in writing immediately of any action taken or approved by the D-Committee. 2.4. The duties of the D-Committee shall be to: (1) keep the Parties apprised of any development issues with re...
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  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • 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.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Development Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones) B. Estimated total development time