Joint Manufacturing Plan definition

Joint Manufacturing Plan has the meaning set forth in Section 6.7.
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Joint Manufacturing Plan has the meaning set forth in Section 8.02 (Joint Manufacturing Plan) hereof.
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Examples of Joint Manufacturing Plan in a sentence

  • Each Party shall maintain complete and accurate records (in the form of technical notebooks and/or electronic files where appropriate) of all work conducted by it under the Joint Manufacturing Plan and all Information resulting from such work.

  • On an annual basis (no later than [*]), or more often as the Parties deem appropriate, the Parties shall prepare amendments to the then-current Joint Manufacturing Plan and submit such draft amendments to the JMC for review and approval.

  • The reasonable costs and expenses incurred by Medivation in accordance with the Joint Manufacturing Plan, including without limitation any internal personnel costs, in carrying out such transfer shall be shared as a Joint Development Cost.

  • The Parties agree to share responsibilities with respect to the manufacture and supply of Products as provided in this Article 7 under the direction of the JMC, and, to the extent applicable, pursuant to the Joint Manufacturing Plan.

  • Once approved by the JMC, the amended Joint Manufacturing Plan (including the corresponding budget) shall become effective and supersede the previous Joint Manufacturing Plan.

  • Each amended Joint Manufacturing Plan shall also contain a corresponding budget, which budget shall appropriately itemize the costs separately for each Product.

  • The initial Joint Manufacturing Plan for the first year of the Collaboration is attached hereto as Exhibit 7.2(b).

  • The Joint Manufacturing Plan may be updated or amended more often as the Parties deem appropriate.

  • In the event of any inconsistency between any plan hereunder (including the Joint Development Plan, Joint Commercialization Plan or Joint Manufacturing Plan) and this Agreement, the terms of this Agreement shall prevail.

  • Unless otherwise determined by the JMC or set forth in a Joint Manufacturing Plan, Astellas shall have primary operational responsibility under each Joint Manufacturing Plan for all Manufacturing activities, if any, with respect to Products not covered in clauses (a) and (b) above, including CMC Activities designed to support receipt of Regulatory Approvals therefor and formulation activities.

Related to Joint Manufacturing Plan

  • Manufacturing Process means any process for—

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

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

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

  • 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;

  • 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 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 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.

  • Marketing Plan means a plan or system concerning a material aspect of conducting business. Indicia of a marketing plan include any of the following:

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

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

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

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

  • Development Program means the implementation of the development plan.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

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

  • 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.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;