Global Manufacturing Plan definition

Global Manufacturing Plan has the meaning set forth in Section 6.1.
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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

  • Such plan shall: (i) be included in the Global Development Plan or the Global Manufacturing Plan for such Licensed Product; (ii) include an allocation of responsibility between IGM and Sanofi with respect to the conduct of the manufacturing process Development activities outlined in such plan; and (iii) be subject to review and approval by the JDC and JMC to the same extent as such Global Development Plan or Global Manufacturing Plan, as applicable.

  • In the event of any inconsistency between a Global Manufacturing Plan, on one hand, and this Agreement or the applicable Clinical Manufacturing and Supply Agreement, on the other hand, the terms of this Agreement or such Clinical Manufacturing and Supply Agreement, as the case may be, will prevail.

  • IGM will use Commercially Reasonable Efforts to conduct and to timely complete the Manufacturing activities for which IGM is responsible under each Global Development Plan or Global Manufacturing Plan, or the applicable Clinical Manufacturing and Supply Agreement or Clinical Quality Agreement, in each case, pursuant to the timelines set forth therein (as such timelines may be amended from time to time by the JMC) and under the oversight of the JMC.

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

  • Each amended Global Manufacturing Plan will become effective and supersede the previous Global Manufacturing Plan as of the date of approval by the JSC.

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

  • 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”).

  • No update or amendment to the Global Manufacturing Plan will be effective unless and until approved by the JMC in accordance with Section 8.6.2(b) (JMC Specific Responsibilities).

  • RCMP • Notify evacuees;• Enforce the evacuation order where empowered by legislation;• Identify evacuation routes; and• Manage the movement of evacuees out of the threatened area.

  • Each Party will promptly provide any such proposed amendment to the Global Manufacturing Plan to the JMC for review and discussion.

Related to Global Manufacturing Plan

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

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

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

  • 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.

  • Distillery manufacturing license means a license issued in accordance with

  • 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, 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.

  • 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, 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 (cGMP) and all applicable governmental rules and regulations as applied at the site(s) of manufacture and control, as amended from time to time and in effect during the term of this License Agreement.

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