Manufacturing Committee. (a) The parties and the Sublicensee shall form a committee as of the Effective Date to address Manufacturing issues relating to the Product (the "Manufacturing Committee"). Gilead, Eyetech and the Sublicensee shall each designate two (2) representatives with appropriate expertise to serve as members of the Manufacturing Committee and shall list those initial representatives Attachment 3. Either party or the Sublicensee may replace its representatives serving on the Manufacturing Committee from time to time by written notice to the other party(-ies) and/or the Sublicensee specifying the prior representative(s) to be replaced and the replacement(s) therefor. Gilead and Eyetech shall select one (1) such person each to serve as joint chairpersons of the Manufacturing Committee. The joint chairpersons of the Manufacturing Committee shall be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting, and preparing and issuing minutes of each such meeting within thirty (30) days thereafter.
(b) The Manufacturing Committee shall hold meetings at such times and places as it elects to do so, but in no event shall it hold meetings less frequently than once every calendar quarter. Meetings may be held by audio or video teleconference with the consent of each party, provided that at least one (1) meeting per year shall be held in person unless agreed otherwise between the parties. Each party shall be responsible for all of its own expenses of participating in the Manufacturing Committee. Meetings shall be effective only if at least one (1) representative of each party is present or participating.
(c) Except as otherwise expressly provided, the role of the Manufacturing Committee shall be advisory, with the goal of serving as a forum for the sharing of information and for the purpose of preventing, or informally resolving (if they are able to facilitate mutual agreement between the parties), disputes between the parties. The Manufacturing Committee shall not have any power to amend, modify or waive compliance with this Agreement. The Manufacturing Committee shall operate as to matters within its jurisdiction by consensus.
(d) The Manufacturing Committee shall:
(i) evaluate factors such as Manufacturing risk and Eyetech's needs for supply of Product from Gilead based on Eyetech's Planning Forecast;
(ii) plan and implement appropriate and mutually agreeable changes to Gilead's Manufacturing capacity as determined pursuant to Section 2...
Manufacturing Committee. The Parties shall form a committee on the Effective Date to address Manufacturing issues as set out in Clause 10.4 relating to Product Supplies to Gilead. Gilead and APO shall designate an equal number of representatives with appropriate expertise to serve as members of the Manufacturing Committee. A Party may replace its representatives serving on the Manufacturing Committee from time to time by written notice to the other Party specifying the prior representative(s) to be replaced and the replacement(s) therefor. Gilead and APO shall select one (1) such person each to serve as joint chairpersons of the Manufacturing Committee. The joint chairpersons of the Manufacturing Committee shall be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting, and preparing and issuing minutes of each such meeting within thirty (30) days thereafter.
Manufacturing Committee. (i) The JV Parties have jointly established a manufacturing committee (the “Manufacturing Committee”), [***]. The members of the Manufacturing Committee shall serve at the pleasure of the JV Party appointing them and may be removed from the Manufacturing Committee and replaced by such JV Party at any time with or without cause.
(ii) NTC’s members of the Manufacturing Committee shall be employees of NTC, and MNL’s members of the Manufacturing Committee shall be employees of Micron, in each case who are responsible for product loading and planning decisions and who can coordinate the loading of product at the Joint Venture Company level.
(iii) The JV Parties shall use best efforts to cause the Manufacturing Committee to be responsible for [***]. In reaching such decisions, the Manufacturing Committee may take advice and input from such sources as it deems appropriate.
(iv) In the event that the members of the Manufacturing Committee cannot agree on product loading decisions, then the Manufacturing Committee will permit, with respect to each Process Node, [***].
(v) The allocation of Trench DRAM Manufacturing Capacity shall be based on [***] (“Baseline Flow”). On a quarterly basis, or as otherwise determined by the Manufacturing Committee, the Manufacturing Committee shall determine the Baseline Flow. If, during any quarter, the Manufacturing Committee cannot agree on a Baseline Flow, [***].
(vi) Requests of Micron and NTC for products or product mixes different from the pre-planned Baseline Flow with respect to a fab shall be honored, except to the extent honoring such request would lead to wafer starts for the non-Baseline Flow products at such fab resulting in Micron or NTC receiving more than the Trench DRAM Manufacturing Capacity and or Stack DRAM Manufacturing Capacity allocated to such Person under the current Baseline Flow for such fab. To the extent that both Micron and NTC request changes in products or product mixes at a given fab that result in [***], the Manufacturing Committee shall re-determine the allocation of Trench DRAM Manufacturing Capacity and Stack DRAM Manufacturing Capacity based on [***], which shall then be the basis for its loading plans with respect to such fab.
(vii) The JV Parties shall use best efforts to cause the Joint Venture Company to ensure that Trench DRAM Manufacturing Capacity and Stack DRAM Manufacturing Capacity at each fab is allocated as provided for in this Section 7.2.
(viii) The Manufacturing Committee shall mee...
Manufacturing Committee. At the first JSC meeting, the JSC shall establish a joint manufacturing subcommittee (the “JMC”), with subject matter experts from each Party, to oversee decisions and facilitate communications between the Parties with respect to the supply of Product to VIT. The JMC shall be responsible for determining the strategy and timing for supply of Drug Substance and Bulk Drug Product for the U.S. and VIT Territory (which may include supply by VIT or its Affiliate or by a Third Party CMO through ChemoCentryx, and may include commencing qualification of such supplier prior to Regulatory Approval of the Product in the VIT Territory), selecting and overseeing the qualification of Third Party CMOs (including secondary suppliers) for supplying Compound as bulk drug substance (“Drug Substance”) and Bulk Drug Product to VIT for Commercial use in the VIT Territory; provided that ChemoCentryx shall retain all control over the strategy and implementation of supply of Drug Substance and Bulk Drug Product for outside the VIT Territory. Unless agreed otherwise by the Parties, ChemoCentryx shall directly engage such CMOs for such supply. Decisions of the JMC will be made by consensus of the JMC, without escalation to the JSC or the Executive Officers.
Manufacturing Committee. (i) The Shareholders shall jointly establish a manufacturing committee (the “Manufacturing Committee”) of the Joint Venture Company, [***]. The members of the Manufacturing Committee shall serve at the pleasure of the Shareholder appointing them and may be removed from the Manufacturing Committee and replaced by such Shareholder at any time with or without cause.
Manufacturing Committee. Promptly after the execution of this Agreement, the Parties shall form a manufacturing committee consisting of two (2) designees from each Party (the "Manufacturing Committee") for the purpose of (a) overseeing the supply of Cytotoxic Compound and AB-Cytotoxic Product under this Agreement and the separate supply agreements entered into pursuant to Section 5.2 of this Agreement, (b) overseeing the establishment of systems for forecasting, ordering and delivering Cytotoxic Compound and AB-Cytotoxic Products under this Agreement and the separate supply agreements entered into pursuant to Section 5.2 of this Agreement, (c) overseeing the transfer of the [ * ] to Millennium for the purpose of Millennium's exploiting its [ * ] under this Agreement, (d) overseeing the transfer of [ * ] by Millennium to ImmunoGen for the purpose of ImmunoGen's [ * ] in accordance with the terms of this Agreement, (e) determining the need to purchase dedicated equipment on behalf of Millennium for the purpose of supply under this Agreement and the separate supply agreements entered into pursuant to Section 5.2 of this Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company's application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act. Agreement, (f) discussing the expertise, capacity and selection of existing and prospective contract manufacturers, and (g) such other matters as the Parties shall mutually agree to delegate to the Manufacturing Committee. The Manufacturing Committee shall meet at such times and places as are mutually agreed to by the Parties. The Manufacturing Committee shall act as a facilitator of the Parties with the understanding that all required approvals and consents for actions under this Agreement, and the separate supply agreements entered into pursuant to Section 5.2 of this Agreement, shall require the approval or consent of the Parties.
Manufacturing Committee. (A) Micron and Intel hereby establish a manufacturing committee (the “Manufacturing Committee”) to, among other things, consult with the Members of each of the Applicable Joint Ventures regarding its output of Joint Venture Products. The membership, functions, objectives and procedures of the Manufacturing Committee are more fully set forth in Appendix B to this Agreement.
(B) The Manufacturing Committee shall have a planning subcommittee (the “Planning Subcommittee”). Micron and Intel shall, and shall cause their respective Relatives that are Members under any Applicable Joint Venture Agreement to, submit the reports and analysis produced by the manufacturing planning personnel of the Applicable Joint Ventures to the Planning Subcommittee. The Planning Subcommittee will formulate recommendations to be submitted to the Manufacturing Committee for approval and action. The membership, functions, objectives and procedures of the Planning Subcommittee are more fully set forth in Appendix B to this Agreement.
Manufacturing Committee. At the request of Amgen, the Parties shall establish a Manufacturing Committee to regularly coordinate and discuss matters related to manufacturing and supply of Drug Product hereunder. The Manufacturing Committee shall be a forum for the Parties to discuss supply matters, but shall not have binding authority or authority to amend, modify or waive compliance with this Agreement. The Manufacturing Committee shall be formed promptly following request by Amgen. Unless otherwise agreed by the Parties, the Manufacturing Committee shall be comprised of three members appointed by Amgen and three members appointed by Purchaser. The Manufacturing Committee shall be led by two co-chairs, one appointed by each of the Parties. The Manufacturing Committee shall have the right to delegate any of its responsibilities to one or more subcommittees as it determines appropriate. Each Party shall have the right to replace its committee members or co-chairs by written notice to the other Party. The Manufacturing Committee shall meet quarterly in person, via teleconference or videoconference or otherwise, or as otherwise agreed by the Parties. Each Party shall be responsible for its own expenses relating to such meetings. As appropriate, other employee representatives of the Parties may attend Manufacturing Committee meetings as nonvoting participants, but no Third Party personnel may attend unless otherwise agreed by the Parties. Each Party may also call for special meetings as reasonably required to resolve particular matters requested by such Party by at least five business days written notice to the co-chair appointed by the other Party. All committee meetings must have at least one member appointed by each Party in attendance. Amgen shall have the right to terminate its participation in the Manufacturing Committee by [*] days prior written notice to Purchaser. Unless and until a Manufacturing Committee is established hereunder, or in the event the Manufacturing Committee is terminated hereunder, matters subject to the Manufacturing Committee shall be dealt with directly between Amgen and Purchaser.
Manufacturing Committee. 6.1 Within thirty (30) days of the Effective Date, the Parties shall establish a manufacturing committee (“Manufacturing Committee”) to assist in the overseeing of and making of recommendations and decisions relating to Manufacturing and regulatory matters relating to Manufacturing in the Territory. The Manufacturing Committee shall be comprised of two voting members from each respective Party (each a “Member”), one representing the CMC function and the other representing the regulatory function. Each Party may replace its Members at any time upon prior written notice to the other Party.
6.2 Each Party shall designate one of its Members as a co-chair of the Manufacturing Committee, and such co-chairs shall serve as the primary points of contact between the Parties with respect to matters relating to this Agreement and to resolve issues or disagreements between the Parties, as needed.
6.3 The Manufacturing Committee shall meet no less frequently than once per calendar quarter during the period of Development of the Products (until the obtaining of Regulatory Approval for the Products in each country of the Key European Territory) and thereafter at least once per year. At least one (1) meeting per year shall be in person, and the remaining meetings may be conducted by telephone or by videoconference. Minutes of the meetings shall be issued, with the responsibility for taking and issuing minutes alternating between the Parties. In person meetings shall alternate between Nicox’s facilities and Insite’s facilities, or such other location mutually agreed by the Manufacturing Committee, on such date and at such time as agreed to by the Manufacturing Committee.
6.4 All Members from each Party or their permitted designees must be present (including presence by telephone or video conference) at any meeting of the Manufacturing Committee for such meeting to proceed. In-person meetings shall require the physical attendance of all four (4) Members or their designees unless otherwise agreed.
6.5 Each Member shall be permitted to send a suitable designee in his or her place to a Manufacturing Committee meeting. Each Party may permit experts or specialists or other appropriate visitors to attend meetings of the Manufacturing Committee on notice to the other, provided that they shall not have a vote. Each Party shall be responsible for its own expenses for participating in the Manufacturing Committee and any subcommittee thereof.
6.6 The co-chairs of the Manufacturing Comm...
Manufacturing Committee. The Parties will establish a manufacturing committee (the “Manufacturing Committee”) to oversee all activities relating to Manufacturing of the Product Deliverable. The Manufacturing Committee shall be composed of representatives from each Party in the following areas of expertise: (i) alliance management/project management, (ii) quality control/analytical development, (iii) Manufacturing / bioprocess development and (iv) quality assurance. The Manufacturing Committee will meet and manage the project schedule set forth in Schedule A.
