Manufacturing Working Group definition

Manufacturing Working Group has the meaning set forth in Section 6.1.
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Manufacturing Working Group or "MWG" has the meaning set forth in Section 4.3 herein.
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Manufacturing Working Group has the meaning set forth in Section 2.4.2.
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Examples of Manufacturing Working Group in a sentence

  • The Manufacturing Working Group will report to the JDC for Development-related Manufacturing matters and will report to the JCC for Commercialization-related Manufacturing matters.

  • The Parties, in accordance with the allocation of responsibilities determined by the JMC, shall be responsible for Manufacturing or having Manufactured all pre-clinical, clinical and commercial supplies of the Products in accordance with the Global Manufacturing Plan and subject to the Manufacturing Budget, subject to the oversight of the Manufacturing Working Group and the JMC in consultation with the JDC or JCC, as applicable.

  • The Parties, acting through the Manufacturing Working Group, will ensure the process for Manufacturing a Shared Product [***].

  • Upon the request of the Party conducting an additional Clinical Trial as permitted under this Section 3.3.4, the Manufacturing Working Group shall use Commercially Reasonable Efforts to Manufacture or have Manufactured, at the requesting Party’s expense, clinical supplies for the additional Clinical Trial, but in any event, the Manufacturing Working Group shall not be required to supply clinical supplies for any Clinical Trial being conducted pursuant to this Section 3.3.4 [***].

  • The Parties will share responsibility for Manufacturing clinical supplies of Shared Product as determined by the Manufacturing Working Group.

  • The Party responsible for conducting activities under the Global Manufacturing Plan will be responsible for determining how to carry out the day-to-day operations with respect to such activities; provided such activities are conducted in accordance with the Global Manufacturing Plan, Manufacturing Working Group guidance and strategy and all Applicable Laws.

  • The Manufacturing Working Group will report to the JMC, and will collaborate with the other functions on the Project Team.

  • 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.


More Definitions of Manufacturing Working Group

Manufacturing Working Group or “MWG” has the meaning given in Section 3.3(b), hereto.
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Manufacturing Working Group means the Working Group formed under Section 3.6(b) to plan and implement the transfer contemplated by Section 6.1(c).
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Related to Manufacturing Working Group

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • 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;

  • Working Group means representatives of the Applicable Registry Operators and other members of the community that the Registry Stakeholders Group appoints, from time to time, to serve as a working group to consult on amendments to the Applicable Registry Agreements (excluding bilateral amendments pursuant to Section 7.6(i)).

  • 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.

  • 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.

  • Manufacturing Process means any process for—

  • 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.

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Development Program means the implementation of the development plan.

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

  • Manufacturing Site means a location where a manufacturing

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Development Works means the external development works and internal development works on immovable property;

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

  • Research Program has the meaning set forth in Section 2.1.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Manufacturing Costs means the costs of Processing that generate Manufacturing Proceeds received by Grantor.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Manufacturing Cost means [***].

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

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

  • Research Program Term has the meaning set forth in Section 2.2.

  • Project Plan means the document to be developed by the Contractor and approved by Webel Technology Ltd., based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by Webel Technology Ltd. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Development Work means the conduct of preclinical and clinical trials, the compilation of the regulatory dossier concerning Licensed Products and the conduct of other work necessary or useful for obtaining Regulatory Approval of Licensed Products.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.