Product Development Committee. The parties hereto ----------------------------- shall establish a committee (the "Product Development Committee") having three (3) representatives named by Cheminor and three (3) representatives named by Schein, with a mandate to (i) select Product for development, (ii) rationalize current Finished Dosage Form Product and Bulk Substance development pipelines, (iii) establish a Finished Dosage Form Product and Bulk Pharmaceutical Substance development process to optimize the use of both Schein's and Cheminor's development infrastructure, (iv) provide each party hereto with access to product and process development infrastructures to maximize the overall scope of the parties' combined Product development pipeline and (v) establish a working group to identify and prioritize future custom synthesized and Product development projects. Without limiting the generality of the foregoing, the Product Development Committee shall, among other matters, promptly ascertain from Schein and Cheminor and review all Products currently produced or under development, thereafter evaluate all Products under development or proposed for development by any party hereto at any time prior to the Termination Date, review and approve a development program to support an application for Regulatory Approval for each Product that is subject to either the Schein Distribution Right or the Cheminor Distribution Right, and monitor the progress thereof, which development program shall include without limitation the following phases: initiation; preformulation development; formulation development; scale-up work; submission batch; validation batch; bio-equivalence; and submission of application for Regulatory Approval (ANDA or non-U.S. equivalent). The Product Development Committee shall consider all factors relevant to developing a non-infringing Product (in compliance with Applicable Law) that is bio-equivalent to the related Reference Drug and obtaining Regulatory Approval as expeditiously as possible. The Product Development Committee may consult with outside experts in making decisions, including without limitation statisticians and patent advisors. The Product Development Committee shall meet at least once each calendar quarter and otherwise at the call of either party at a mutually acceptable location or by telephone if mutually acceptable to the parties. If Cheminor and Schein cannot agree on a mutually acceptable location, the meetings shall take place at locations selected alternately ...
Product Development Committee. The Parties shall also form a Product Development Committee which shall be responsible for developing worldwide strategies for Marketing Studies that build value for the Products and shall act in an advisory capacity with respect to (i) the clinical development and Product Approval of the Products in the Territories and (ii) potential combination therapies using the Products, the products to be co-promoted by the Parties under the Co-Promotion Agreement, and/or one or more other pharmaceutical products. The Product Development Committee shall include an equal number of representatives from Xxxxxx and Triangle and shall be chaired by a Triangle representative. It shall generally follow the rules established by Section 4.2(a)(i) through (vi) for the U.S. Marketing Board, except that final decisions with respect to Marketing Studies shall be made by Triangle with respect to Marketing Studies proposed or requested by the U.S. Marketing Board and by Xxxxxx with respect to Marketing Studies proposed or requested by the International Marketing Board, irrespective of the country or countries in which such Marketing Studies are conducted.
Product Development Committee. The Product Development Committee will be responsible to ensure the integration of the product development processes of each Party, and that both Parties follow a clearly defined product development process to address new products and services, and time to market requirements. This Committee is committed to continued process improvement and is responsible for business case development of new products and service. SBC will be the party responsible for delivering the products and services requested by both Parties with joint development of the core infrastructure by Willxxxx. Xxy components of this agreed upon process are: marketing service descriptions, technical service description and intercompany teams. This Committee will agree upon required resources and timelines around each stage of the development process. This Committee will ensure that SBC receives Alliance Pricing on all products and services from Willxxxx xxxre Willxxxx xx the Supplying Party, and that Willxxxx xxxeives Alliance Pricing on products and services from SBC where SBC is the Supplying Party.
Product Development Committee. (a) The Parties hereby establish a product development committee (the "Product Development Committee" or "PDC"), which shall consist of representatives from each of SkyePharma and Endo, with up to four members from each Party on such Committee unless otherwise agreed to by the Parties in writing. Each of SkyePharma and Endo may replace any or all of its representatives on the PDC at any time upon written notice to the other in accordance with Section 13.5 of this Agreement. Such representatives shall be employees of each such Party, and those representatives of each such Party shall, individually or collectively, have expertise in pharmaceutical drug development, regulatory matters, marketing, clinical studies, and/or other expertise to the extent relevant. Any member of the PDC may designate a substitute with due authority to temporarily attend and perform the functions of that member at any meeting of the PDC. SkyePharma and Endo each may, in its sole discretion but subject to the written objection of the other Party (with demonstrable reason for objection), invite to attend meetings of the PDC a reasonable number of non-member representatives of such Party (including, without limitation, its employees or non-employee professional advisors), who have a reasonable purpose for attending such meeting. The PDC shall be chaired by a representative of SkyePharma. The secretary of the PDC shall be a representative of SkyePharma.
Product Development Committee. 13 2.4 JOINT COMMERCIALIZATION COMMITTEE...............................14 2.5 JOINT MANUFACTURING COMMITTEE...................................16 2.6 MINUTES OF COMMITTEE MEETINGS...................................17 2.7 TERM............................................................18 2.8 EXPENSES........................................................18 2.9 ALLIANCE MANAGERS...............................................18 3.
Product Development Committee. The Parties hereby establish the PDC to facilitate the Development Program as follows:
Product Development Committee. The Parties shall establish a Product Development Committee which shall (a) develop, approve and amend the development plan with respect to Connetics' duties in the Territory, and (b) provide overall direction, monitor progress, manage information exchange between the Parties, decide key strategies and solve problems with respect to the development of the Technology and of the Products in the Territory. At the first meeting of the Product Development Committee, the members shall establish a regular meeting time (which shall be, at a minimum, quarterly) and structure. Each Party shall appoint a key individual, who shall be responsible for coordinating timing and agenda of meetings, and for ensuring that the Party is represented by the appropriate persons at each meeting (based on the proposed agenda for that meeting).
Product Development Committee. Company agrees to use commercially reasonable efforts to commercialize the Technology in the Field. AVI and Company acknowledge that the development process for new technologies is uncertain and that unforeseen issues may arise. In order to ensure that Company is pursuing the Technology and to accommodate the uncertainty of product development, the parties agree to the following:
Product Development Committee. The Parties shall establish and maintain a joint product steering committee (the “Joint Product Steering Committee”), made up of at least one (1) representative of each Party, to identify prospective joint development opportunities and coordinate efforts between the Parties therefor. The Parties shall enter into an agreement (the “Joint Product Agreement”) to address, among other things, exclusivity and ownership rights with respect to any joint product development that the Parties may mutually agree to pursue.
Product Development Committee. 13 2.4 Joint Commercialization Committee.............................14 2.5 Joint Manufacturing Committee.................................16 2.6 Minutes of Committee Meetings.................................17 2.7 Term..........................................................18 2.8 Expenses......................................................18 2.9
