Manufacturing Working Group. After the Effective Date, the JMC will establish a manufacturing working group (the “Manufacturing Working Group”) to operationalize the Manufacture of the Products in accordance with a global manufacturing plan (the “Global Manufacturing Plan”), including the corresponding budget (the “Manufacturing Budget”), to be prepared by the Manufacturing Working Group within [***] days after the Effective Date and shall be approved by the JMC thereafter. The JMC will select the members of the Manufacturing Working Group as provided in Section 2.5.2(a) and in this Section 6.2. Unless otherwise mutually approved by the Parties in writing: (x) [***] will be the lead party on Manufacturing matters; provided that at all times at least [***]% of the members of the Manufacturing Working Group will be [***] representatives; (y) the leader of the Manufacturing Working Group will act as the Manufacturing Lead on the Project Team; and (z) a majority of the members of the Manufacturing Working Group shall be dedicated to the Manufacture of the Products under this Agreement on a full-time basis, unless otherwise mutually agreed by the Parties in writing; provided, however, that any member of the Manufacturing Working Group who is not dedicated to the Manufacture of the Products under this Agreement on a full-time basis must be sufficiently dedicated to such Manufacture to permit such person to be reasonably and consistently available to participate in the activities of the Manufacturing Working Group. The Manufacturing Working Group will report to the JMC, and will collaborate with the other functions on the Project Team. The Manufacturing Working Group’s responsibilities will include: (a) on an [***] basis (or more frequently as needed), preparing updates to the Global Manufacturing Plan, including the Manufacturing Budget, and submitting such updates to the JMC for review, discussion and approval in accordance with Section 2.5.2(i); (b) developing plans to transfer Manufacturing-related Know-How between the Parties as needed to facilitate the Manufacture of the Products; (c) establishing standards applicable to each Party’s Manufacturing activities and reviewing each Party’s performance against such standards; (d) conducting technical reviews; (e) making recommendations to the JMC regarding capacity planning, supply plans and supply continuity planning for the Products; (f) making recommendations to the JMC regarding the Manufacturing process for each Shared Product and any c...
Manufacturing Working Group. Within [***] calendar days after the Effective Date, Arcellx and Kite shall establish a manufacturing working group (the “MWG”), which shall report to the JSC and shall have responsibility for overseeing the implementation of all Manufacturing aspects of the collaboration established by this Agreement, including global manufacturing process, formulation, and Manufacturing Transfer between Arcellx, Kite and Arcellx’s Third Party manufacturers, including the review and approval of any amendment to the Manufacturing Transfer Plan, and review of Supply Costs. The MWG shall also contribute to and review the Core Development Plan and Core Development Budget. Until formal establishment of the MWG, appropriate representatives from the Parties’ (or their Affiliates’) manufacturing and quality functions shall perform the functions of the MWG. In conducting its activities, the MWG shall operate and make its decisions consistent with the terms of this Agreement.
Manufacturing Working Group. The MWG consists of 3 members from LILLY and 3 members from ISIS. The members must be individuals who are capable of responding to the technical, financial, quality, and other issues that could arise under this Agreement. The MWG can consult with, and receive assistance from, LILLY and ISIS employees who are not MWG members. The additional objectives of the MWG are (i) with the parties' quality units, to adopt the initial Quality Agreement and MRD and subsequent amendments (if any) to each; (ii) to agree on specific Delivery dates for each Firm Order and discuss and agree upon any current forecasting issues; (iii) monitor the parties' performance under this Agreement, including reviewing, on a periodic basis, forecast accuracy, on-time delivery and API Supply Price elements; and (vi) monitor and review the parties' performance under the Loan Agreement, including disbursements and the use of the loan proceeds. The MWG shall report to the parties at least once each calendar quarter and more frequently as requested. LILLY will designate one of its representatives as chairman of the MWG. In the event of a tied vote, the MWG chairman will refer the matter to the LILLY Product Team Leader, who will have final decision-making authority; however, ISIS will not be required to make any financial investment pursuant to such a decision without its agreement, unless such investment is required under the terms of this Agreement. In the event ISIS disagrees with a decision made by the LILLY Product Team Leader, the issue can be brought to the Oversight Committee (see Section 15.6).
Manufacturing Working Group. The Parties shall establish a manufacturing and supply chain working group (the “MWG”) in accordance with the terms of the Supply Agreement to oversee manufacturing of the Compound and Product in accordance with the Parties’ respective responsibilities under Section 4.7.
Manufacturing Working Group. The Manufacturing Working Group shall have responsibility for monitoring and facilitating the overall progress of Manufacturing activities under this Agreement with respect to Products in the Field, including oversight of the various budgets and activities. In particular, the Manufacturing Working Group shall:
6.2.1. develop the transition plan to transfer to AbbVie any Know-How related to the Manufacture of Products and to transition the Manufacture of Products to AbbVie in accordance with Section 6.1.1;
6.2.2. establish standards applicable to the Parties’ performance of Manufacturing activities in accordance with the GDP, each Commercialization Plan and this Agreement, and review each Parties’ performance against such standards;
6.2.3. meet at least quarterly for technical reviews to ensure timely exchange of CMC Development plan technical progress, communication and technical consultations;
6.2.4. share planning and budgeting information with the JDC and JCC and coordinate with the JDC and JCC in preparing comprehensive planning and budgeting proposals with respect to the Manufacturing activities for the Development and Commercialization of Products in the Field; and
6.2.5. perform such other functions as are assigned to it in this Agreement or as are appropriate to further the purposes of this Agreement as agreed in writing by the Parties.
Manufacturing Working Group. Notwithstanding Arrowhead’s responsibility for the Arrowhead Manufacturing Activities, within [***] after the Effective Date, the JSC will establish a manufacturing working group (“MWG”) that will (a) facilitate and monitor the Arrowhead Manufacturing Activities; (b) evaluate and select a replacement CMO for drug product; (c) prepare a plan for the conduct of the Manufacturing Technology Transfer described in Section 6.4 (Manufacturing Technology Transfer); and (d) ensure such other plans and processes are developed to enable uninterrupted supply of Clinical Trial Materials under and in accordance with this Agreement and the CTM Supply Agreement. The MWG will include representatives from each Party’s pharmaceutical science, manufacturing and supply, and quality groups.
Manufacturing Working Group. The Parties shall establish a manufacturing and supply chain working group (“MWG”) to oversee manufacturing of the Compound and Product in accordance with the Parties’ respective responsibilities under Section 4.7 of the License Agreement. The Parties shall collaborate through such MWG to oversee manufacturing of Compound and Product for clinical supplies and for commercial distribution and sale. The MWG will act by consensus with the objective of achieving reliable supply on a cost effective basis, provided however that in the event that the members of the MWG are unable to agree on a particular issue, then the decision making process described in Section 3.1(c) of the License Agreement shall apply and Xxxxxx Xxxxx shall have final decision making authority with respect to manufacturing of Compound and Forest shall have final decision making authority with respect to manufacturing of Product, provided that in each case, such party’s decision is consistent with the Compound Specifications, cGMPs and other Applicable Laws.
Manufacturing Working Group. Within [****] after the Effective Date, the Parties shall establish a manufacturing Working Group (the “Manufacturing Working Group”). The Manufacturing Working Group is deemed established by the JSC. Subject to the oversight of the JSC, the Manufacturing Working Group shall perform the following functions:
(a) serve as a forum for discussing the Manufacturing activities, including manufacturing process or Development, design and optimization, change control, quality matters, and commercial supply of the Licensed Compounds and Licensed Products;
(b) discuss and manage the operative aspects of Manufacturing, including Regulatory Approval-related matters and whether to establish any [****] supply arrangements, which may include establishing a [****] source of Licensed Compounds or Licensed Products, which [****] source may be a Party or a Third Party;
(c) determining when to transfer the Drug Product Manufacturing Process and the Drug Substance Manufacturing Process to AbbVie or its designee pursuant to Section 4.1.2 and coordinate the activities with respect to any such transfer; and
(d) perform such other functions as are expressly assigned to the Manufacturing Working Group under this Agreement or by the JSC or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.
Manufacturing Working Group. Upon agreement of the JDC or direction by the JSC, Pharmacyclics and JBI shall establish a joint Manufacturing Working Group (the “Manufacturing Working Group”), which shall report to the JDC and shall have responsibility for overseeing the implementation of all Manufacturing aspects of the collaboration established by this Agreement, including global manufacturing process, formulation, technology transfer between Pharmacyclics, JBI and their Third Party manufacturers. Until formal establishment of the Manufacturing Working Group, appropriate representatives from the Parties’ (or their Affiliates’) manufacturing and quality functions shall perform the functions of the Manufacturing Working Group. In conducting its activities, the Manufacturing Working Group shall operate and make its decisions consistent with the terms of this Agreement. [**] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Manufacturing Working Group. The Parties shall establish a Joint Manufacturing Working Group (the “Manufacturing Working Group”) under the JSC for the purpose of ensuring excellence in the execution of all manufacturing aspects of the Product(s) through the close collaboration of the representatives of the Parties as members of the Manufacturing Working Group. The Manufacturing Working Group shall have equal membership from each Party, with there being at least one (1) member from each Party. The Manufacturing Working Group shall have the authority to review and discuss all the manufacturing plans and any other relevant documents and oversee all the manufacturing activities, to the extent such plans, documents and activities are directly related to the Products to be delivered to Innovent, provided that Innovent shall have the right to provide comments to such plans, documents and activities to AnHeart, if AnHeart unreasonably refuses the comments, Xxxxxxxx may submit the relevant matters to JSC for its decision.
