Licence to Manufacture definition

Licence to Manufacture means the conditional rights to manufacture granted to Bayer under Clause 2.4 of the Licence and Distribution Agreement and more particularly described in Clause 8.2 of this Agreement.
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Examples of Licence to Manufacture in a sentence

  • Every application for a Licence to Manufacture Explosives shall be made to the Chief Inspector and the applicant shall supply all information that the Minister or the Chief Inspector may require in respect to the location of the proposed factory, its buildings and magazines, and the processes or operations proposed to be used and employed.

  • Licence to Manufacture a Blasting Agent (1) Any person intending to mix and use a blasting agent shall first apply to the Chief Inspector for a Licence to Manufacture a Blasting Agent and shall pay the prescribed fee specified in the Second Schedule.

  • Licence to Manufacture a Blasting Agent(1) Any person intending to mix and use a blasting agent shall first apply to the Chief Inspector for a Licence to Manufacture a Blasting Agent and shall pay the prescribed fee specified in the Second Schedule.[(2) repealed][Regulation 30 amended in Gazette 23 Oct 1969 p.

  • Licence conditions and limitations In granting a Licence to Manufacture Explosives in respect of a factory the Minister shall specify the maximum quantities of explosive ingredients or finished explosives that may be kept in any building within the factory and the distances that such buildings are to be from each other and from other buildings or works, and such quantities shall not then be exceeded at any time without approval given in writing by the Minister.21.

  • Application of licence A Licence to Manufacture a Blasting Agent shall be granted for one year only but may be renewed at the discretion of the Chief Inspector, and such licence shall apply only to the type of blasting agent named therein, and to the place or places specified for mixing and use of the blasting agent.34.

  • Licence holder to make handling rules for employeesThe holder of a Licence to Manufacture Explosives shall make special rules for regulating the conduct and work of persons employed by him in the manufacture of explosives so that proper discipline and safety of those persons is ensured, and, if required by the Chief Inspector, shall make new rules or alter or repeal any rules for regulating processes or persons employed in the factory.24.

  • Guideline for a Licence to Manufacture, Import, Export or Distribute Medical Devices and IVDs. Pretoria: MCC, 2016:1-10.www.mccza.com/Publications/DownloadDoc/5483 (accessed 23 January 2018).

  • Licence holder to make handling rules for employees The holder of a Licence to Manufacture Explosives shall make special rules for regulating the conduct and work of persons employed by him in the manufacture of explosives so that proper discipline and safety of those persons is ensured, and, if required by the Chief Inspector, shall make new rules or alter or repeal any rules for regulating processes or persons employed in the factory.24.

  • An application for a Licence to Manufacture Tobacco provides details of the information required during the licence application process.

  • Licence conditions and limitationsIn granting a Licence to Manufacture Explosives in respect of a factory the Minister shall specify the maximum quantities of explosive ingredients or finished explosives that may be kept in any building within the factory and the distances that such buildings are to be from each other and from other buildings or works, and such quantities shall not then be exceeded at any time without approval given in writing by the Minister.21.

Related to Licence to Manufacture

  • Supply Licence means the licence granted to us under section 6(1)(d) of the Act;

  • Distillery manufacturing license means a license issued in accordance with

  • 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.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • 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.

  • Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.

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

  • 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;

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • 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.

  • Third Party Manufacturer means (i) a Third Party whose primary business is contract manufacturing, or (ii) a Third Party who has a contractual arrangement with Licensee or with a sublicensee of Licensee that includes manufacturing of Client Product and/or Drug Product by such Third Party for Licensee or such sublicensee.

  • Anti-Static Product means a product that is labeled to eliminate, prevent, or inhibit the accumulation of static electricity. “Anti-Static Product” does not include “Electronic Cleaner,” “Floor Polish or Wax,” “Floor Coating,” and products that meet the definition of “Aerosol Coating Product” or “Architectural Coating.”

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • Product Know-How means Know-How

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

  • Licence Term means the Initial Term plus any Further Term; Licensee means You and/or the Permitted Users;

  • Generation Licence means an electricity generation licence granted or treated as granted pursuant to section 6(1)(a) of the EA 1989 that authorises a person to generate electricity;

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • 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.

  • Modular building manufacturer means a person or corporation who owns or operates a

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Good Manufacturing Practices or “GMP” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant Governmental Authority having jurisdiction over the development, manufacture or sale of the Product in the Territory pursuant to its regulations, guidelines or otherwise.

  • 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.