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.

  • For the avoidance of doubt, nothing in this Section 7.10 with respect to Medivation’s obligation to transfer manufacturing know-how to Astellas shall limit Medivation’s right to use any Manufacturing know-how pursuant to the sublicense granted to Medivation in Section 8.2 in order to fulfill Medivation’s obligations in accordance with the Joint Manufacturing Plan.

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

  • 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.

  • The Manufacturing Coordinators of each Party shall provide updates to JSC regarding such Party’s activities under the Joint Manufacturing Plan.

  • 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.

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

  • The Parties shall use Diligent Efforts to carry out the tasks assigned to them under the Joint Manufacturing Plan in a timely manner.

  • The Parties shall work together to effectuate the contemplated transfer as expeditiously and efficiently as reasonably possible and in a manner to meet the Development and Commercialization timelines in the Joint Manufacturing Plan.

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 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 Agreement has the meaning set forth in Section 4.3.

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

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, 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 has the meaning set forth in Section 4.3(a).

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • 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 means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Manufacturing and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.

  • 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;

  • Good Manufacturing Practices means current good manufacturing practices, as set forth in 21 C.F.R. Parts 210 and 211.