Related to JPC
Research Committee Warner and LeukoSite will each appoint up to 4 representatives to a research committee (the "Research Committee"), which will oversee the pre-clinical aspects of the Collaboration; except that such responsibilities will pass to the Development Committee in the case of a Warner-LeukoSite Product, to Warner in the case of a Warner Product and to LeukoSite in the case of a LeukoSite Product. The Warner representatives on such committee will together have only one vote and the LeukoSite members on such committee will together have only one vote. The Research Committee will meet quarterly, or more frequently if mutually agreed, and will report to the Management Committee. Warner's and LeukoSite's initial representatives to the Research Committee will be appointed by each of them promptly after the Effective Date. The Research Committee will be responsible for recommending compounds to be designated Development Candidates. All actions taken and decisions made by the Research Committee will be by unanimous agreement. The Management Committee will resolve disputes among the members of the Research Committee. A party may change any of its appointments to the Research Committee at any time upon giving written notice to the other party.
Joint Research Committee The Parties hereby establish a committee to facilitate the Research Program as follows:
Joint Patent Committee (a) The Parties will establish a “
Steering Committee Within a reasonable period of time after the Effective Date, Orphan Medical and Celltech shall form a Steering Committee made up of commercial and technical employees from both companies that shall have certain decision-making authority, and provide oversight for the administration of this Agreement. Each party shall maintain two (2) members on the Steering Committee with other members added as needed. The parties shall each select one of its representatives to serve as a co-chairperson of the Steering Committee. The Steering Committee shall have the authority to conduct the following activities and such other activities as may be agreed to in writing by the parties: (a) review ongoing regulatory issues, (b) review the medical aspects of standards of care in the Territory, (c) review clinical developments across territories, (d) review marketing campaigns and new marketing plans, (e) review sales activities and results, (f) review aspects of Product manufacturing campaigns and Product forecasts, consignment and non-consignment inventory stocks and ordering, and (g) review the arrangement for distributing Product on a Named Patient Basis. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the development or manufacture of the Product or the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product outside the Territory, the views of the Orphan Medical Steering Committee members shall prevail. In the event and to the extent that the Steering Committee is unable to come to a consensus on any matter relating to the Registration, packaging, labeling, promoting, marketing, sale or distribution of the Product within the Territory, the views of the Celltech Steering Committee members shall prevail. Notwithstanding the foregoing, in the event a particular matter for which there is no consensus of the Steering Committee could, in the good faith judgment of the party who does not have the ultimate decision making authority as to such matter (as provided in the previous two sentences), materially affect the rights or obligations under this Agreement of such party, Orphan Medical and Celltech agree to use Commercially Reasonable Efforts to resolve the matter in a manner which will minimize the impact on such rights or obligations of such party. During each Contract Year, the parties shall hold at least four (4) regular meetings of the Steering Committee. Members of the Steering Committee may participate in meetings of the Steering Committee in person or by conference telephone call. At least one (1) of the four (4) Steering Committee meetings shall be conducted in-person. Employees of each party who are not members of the Steering Committee may attend meetings of the Steering Committee as required. In-person Steering Committee meetings shall alternate between Orphan Medical's designated facility and a facility designated by Celltech. The co-chairpersons of the Steering Committee shall alternate responsibility for the preparation of minutes setting forth discussions made at each committee meeting, with the Orphan Medical Chairperson preparing minutes for the first Steering Committee meeting; provided, however, that such minutes shall not become official until agreed upon by both co-chairpersons.
Development Committee The PARTIES agree to work together in good faith in the collaboration under this Agreement and to keep each other reasonably informed of its activities hereunder. Additionally, and in support of the foregoing, promptly after the Effective Date, the PARTIES will form a four-member committee (the “Development Committee”), equally represented by EAGLE and SCIDOSE, for the management of the development of the PRODUCTS, which will consist of the Chief Executive Officer and Chief Scientific Officer of each of EAGLE and SCIDOSE. Each Party shall have the right, from time to time, to substitute new members, on a permanent or temporary basis, for any of its previously designated members of the Development Committee. Each Party shall bear its own costs associated with participation in the Development Committee.
Joint Steering Committee Within [***] after the Effective Date, the Parties shall establish the Joint Steering Committee (“JSC”), which shall consist of two (2) members, with each Party designating one (1) of its employees as a member. Each Party may replace its representative on the JSC at any time, upon written notice to the other Party. A Party may designate a substitute employee to temporarily attend and perform the functions of such Party’s designee at any meeting of the JSC. The JSC will meet annually and perform the following functions: serve as a forum for discussion and communication regarding the overall strategy for Development and Commercialization of Products under this Agreement; review and monitor Development and Commercialization activities, including the then-current version of the Development Plan, and results for the period since the last meeting of the JSC; and make any strategic recommendations.
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.
Negotiating Committee The Hospital agrees to recognize a Negotiating Committee comprised of representatives of the Union for the purpose of negotiating a renewal agreement. The number of nurses on the Negotiating Committee is set out in the Appendix of Local Provisions. The Hospital agrees to pay members of the Negotiating Committee for time spent during regular working hours in negotiations with the Hospital for a renewal agreement up to, but not including, arbitration.
Research Collaboration Upon FibroGen’s request, the Parties will discuss conducting a research program funded by AstraZeneca and directed toward franchise enhancement and lifecycle management for HIF Compounds or other topics that the Parties determine relevant to the Products and the Field. Upon agreement on the terms of such research program, the Parties will enter into a separate agreement or amend this Agreement accordingly.
Joint Development Committee Promptly after the Effective Date, the Parties shall form a Joint Development Committee (the “JDC”). The JDC shall (a) oversee Neuromed’s Development of the Product under the Development Plan, (b) act as the forum for Mallinckrodt to provide its input into Development and to keep informed about its progress, and (c) offer its advice to expedite or aid the progress of Development work. The JDC shall be comprised of a total of six (6) appropriately qualified members (or such other even number of members as is agreed to in writing by the Parties), with each of Neuromed and Mallinckrodt designating one half of the total number of members as its representatives. Either Party may replace any of its respective JDC representatives with an appropriately qualified representative at any time with reasonable prior written notice to the other Party. The JDC will meet at least once each month so long as Product is being developed by Neuromed under this Agreement, provided that the JDC may agree from time-to-time to meet at a greater or lesser frequency if appropriate under the circumstances. JDC meetings may be conducted by videoconference, teleconference or in person, as requested by a Party, except that at least one of the meetings per year will be conducted in person. The JDC will agree upon the time and location of the meetings. A Neuromed representative of the JDC will act as the chair, and such chair (or a designee) shall coordinate, prepare and circulate an agenda for each JDC meeting reasonably in advance of the meeting. A reasonable number of additional representatives of a Party may attend meetings of the JDC in a non-voting capacity. The JDC shall seek to reach consensus on matters coming before it, but will not have any authority to decide development matters that are Neuromed’s responsibility under this Agreement. Notwithstanding the preceding provisions of this Section 2.2, Mallinckrodt shall have the right to give its prior written approval for those Development activities or actions set forth and described on Appendix C attached hereto, such approval not to be unreasonably withheld.