Manufacturing and Supply Committee definition

Manufacturing and Supply Committee or “MSC” has the meaning set forth in Section 5.3. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions.
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Manufacturing and Supply Committee means the joint manufacturing and supply committee, comprising representatives of ABX and AZ, described in Section 7.7.
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Manufacturing and Supply Committee or “MSC” 3.9 “Manufacturing Certificate of Analysis” 7.9.2(a) “Milestone Notification Notice” 8.2 “Minimum Delivery Amount” 7.11.1 “Minimum Delivery Cure Period” 7.11.1 “New Indication” 2.6 “Notice of Non-Conformance” 7.9.2(a) “OOS” 7.9.3 “Packaging and Labeling” 7.5 EXECUTION VERSION Term Section
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Examples of Manufacturing and Supply Committee in a sentence

  • The Development Management Committee shall be responsible for supervising and directing the Development Programs, in each case during the applicable Development Program Terms and, in consultation with the Manufacturing and Supply Committee, overseeing the Process Development Programs.

  • Any disputes or disagreements arising in the Manufacturing and Supply Committee that cannot be resolved by the members of the Manufacturing and Supply Committee shall be referred to the Chief Executive Officer of ABX and the Executive Vice President of Operations of AZ (or one of his or her direct reports) for resolution.

  • The Development Management Committee shall have oversight over the Manufacturing and Supply Committee and each Process Development Program.

  • The Development Management Committee, in consultation with the Manufacturing and Supply Committee, shall be responsible for overseeing the performance of each Process Development Program.

  • The Parties shall establish a Joint Manufacturing and Supply Committee ("JMSC") promptly following the date hereof to review and make recommendations to the Parties with respect to manufacturing and supply matters relating to Product.

  • In order to fulfill the objectives of this Agreement, the Parties agree to establish a Steering Committee, Joint Operating Committee ("JOC"), a Clinical Development/Regulatory Committee ("CDRC"), a Global Commercialization Committee ("GCC"), a Manufacturing and Supply Committee ("MSC"), Country Commercialization Committees, and such other committees and subcommittees as may be established by mutual consent of Organon and Pfizer.

  • Within thirty (30) days after the Effective Date, Auxilium and Asahi agree to establish the Manufacturing and Supply Committee (the “MSC”) as a Committee.

  • The initial subcommittees of the JEC will be the Joint Development Committee (“JDC”), the Joint Medical Committee (“JMC”), the Joint Commercialization Committee (“JCC”), and the Joint Manufacturing and Supply Committee (“JMSC”).

  • Promptly, but not later than [**] after the Parties establish the JEC, the JEC shall establish a JMSC, which will be a subcommittee of the JEC and will have the responsibilities set forth in this Section 3.5 (Joint Manufacturing and Supply Committee).


More Definitions of Manufacturing and Supply Committee

Manufacturing and Supply Committee. The Manufacturing and Supply Committee as defined in Section 4.03(a).
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Related to Manufacturing and Supply Committee

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Joint Commercialization Committee or “JCC” has the meaning set forth in Section 2.1(a).

  • Manufacturing Agreement has the meaning set forth in Section 2.6.

  • Manufacturing Process means any process for—

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Development Plan has the meaning set forth in Section 3.2.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • Technical Committee means the body established in accordance with article VII;

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Development Program means the implementation of the development plan.

  • JCC has the meaning set forth in Section 2.1.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Supply Plan has the meaning set forth in the CAISO Tariff.

  • Quality Assurance Program means the overall quality program and associated activities including the Department’s Quality Assurance, Design-Builder Quality Control, the Contract’s quality requirements for design and construction to assure compliance with Department Specifications and procedures.

  • Technical Advisory Committee means a committee established under section 12;