Global Manufacturing Plan definition

Global Manufacturing Plan has the meaning set forth in Section 6.2.
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Global Manufacturing Plan is defined in Section 6.3.1 (Global Manufacturing Plan—Generally).
Sample 1

Examples of Global Manufacturing Plan in a sentence

  • Each Party shall conduct the Manufacturing activities assigned to it in the Global Manufacturing Plan and Budget.

  • No Party shall be required to expand capacity or incur any capital expenditures except as set forth in the Global Manufacturing Plan and Budget.

  • 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.

  • Indeed, all firms use relationships to access new knowledge (Lechner and Dowling 2003).

  • Within […***…] days after the Effective Date, the JSC shall approve the initial Global Manufacturing Plan and Budget for the Autotaxin Program.

  • Either Party may propose amendments the Global Manufacturing Plan and Budget from time to time through its members on the JDC.

  • The Global Manufacturing Plan and Budget may include agreed capital improvements and capital costs; provided, however, that in such case, at the request of either Party, the Parties shall enter into a separate written agreement with respect to such capital improvements and capital costs, including with respect to (i) cost sharing and financing associated therewith and (ii) ownership of such capital improvements.

  • If (a) the applicable Global Development Plan or Global Manufacturing Plan [***] prior to completion of the [***] pursuant to Section 6.5.2 or (b) [***], then, in each case, at [***], the Parties will enter into one or more manufacturing and supply agreements (each, a “Clinical Manufacturing and Supply Agreement”), and associated quality agreements based on the applicable template of the quality agreement attached hereto as Exhibit A (each, a “Clinical Quality Agreement”).

  • The Parties will further work together and reasonably take into account the internal and external reporting requirements and timelines of the other Party (i) when preparing reports pursuant to this ARTICLE IX to the other Party, (ii) when aligning the respective R&D Plan and Budget, Global Commercialization Plan and Budget and Global Manufacturing Plan and Budget for each Optioned Program and Third Party License Payments and (iii) during any other planning-related exercise.

  • So long as the conditions set forth in Section 7.1 for permitting independent Manufacturing activities are met, each Party shall have the right to develop capacity or capabilities beyond those set forth in the Global Manufacturing Plan and Budget but the costs and expenses associated therewith shall be at such Party’s sole expense and such Party shall have no obligation to make such capacity available to the other Party.

Related to Global Manufacturing Plan

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

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

  • Manufacturing Process means any process for—

  • Global Development Plan has the meaning set forth in Section 3.1.

  • Marketing Plan has the meaning set forth in Section 4.3(a).

  • 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, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

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

  • Manufacturing Agreement has the meaning set forth in Section 4.3.

  • 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;

  • 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.

  • 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 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.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • 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.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • API means the American Petroleum Institute.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • 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.

  • 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.

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

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

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