Commercial Manufacturing definition

Commercial Manufacturing or “Commercial Manufacture” means Manufacture of a Licensed Product (including the cost of Manufacturing Licensed Antibody contained in Licensed Product) or acquisition of such Licensed Antibody and Licensed Product from a CMO, in each case, for Commercialization of such Licensed Product in the Territory.
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Commercial Manufacturing means the Manufacture of any Compound or any Product (including the Manufacturing of any Compound contained in any Product) or acquisition of any Compound or any Product from a CMO, in each case, for Commercialization of such Product in the applicable Territory. “Commercial Manufacture” shall have a correlative meaning.
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Commercial Manufacturing means the Manufacture of the Compound or any Product (including the cost of Manufacturing the Compound contained in any Product) or acquisition of the Compound or any Product from a CMO, in each case, for Commercialization of such
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Examples of Commercial Manufacturing in a sentence

  • It is understood and agreed by the parties to the National Standard Agreement for a Commercial Manufacturing and Pipe Fabrication Shop that the nature of this agreement is that of a Manufacturing Agreement, not a Construction Industry Agreement.

  • The Employer agrees not to subcontract out any of the pipe fabrication work covered by this Agreement unless the work to be subcontracted is subcontracted to an Employer who is signatory to the Canadian National Standard Agreement for a Commercial Manufacturing and Pipe Fabrication Shop.

  • It is understood and agreed by the parties to the Canadian National Standard Agreement for a Commercial Manufacturing and Pipe Fabrication Shop under the clause IX (I) Overtime, the practice in this industry is that the rate of pay for all of the regular scheduled hours of a shift is the rate in effect at the commencement of the shift, irrespective of a change of day.

  • The Parties will negotiate the terms and conditions of such Commercial Manufacturing and Supply Agreement in good faith for a period of [***] days (as may be extended upon agreement of the Parties, but in any event such agreement will be entered into prior to the first submission of a NDA for the first TAK-385 Licensed Product).

  • In the event the Parties desire to enter into a Commercial Manufacturing Agreement with each other, such Commercial Manufacturing Agreement shall be on separate terms and conditions from this Agreement.

  • While PRE and its service providers have endeavored to create a secure and reliable website, please be advised that the confidentiality of any communication or material transmitted to/from the Digital Media over the Internet cannot be guaranteed.

  • With respect to Regional Licensed Products (including any Component of a Regional Licensed Product that is a Combination) purchased by Surface from Novartis for use in the Surface Territory, Surface shall pay Novartis an amount equal to Commercial Manufacturing Cost for such Regional Licensed Products.

  • In addition, Dermavant and Thermo Fisher Scientific (“TFS”) entered into a Commercial Manufacturing and Supply Agreement for which TFS will provide a supply of tapinarof to Dermavant at an agreed upon price.

  • Such active Uses may consist of Commercial, Manufacturing- Enabled Retail and/ or Art Gallery.

  • Patheon shall conduct stability studies on the Finished Products according to the Specifications therefor, as required by the FDA or Foreign Regulatory Authorities as advised by Santarus or as requested by Santarus, and in any case on at least one batch of Finished Product from the Facility at least once per calendar year following Commencement of Commercial Manufacturing or more frequently as may be specified in the Quality Agreement.

Related to Commercial Manufacturing

  • Manufacturing means all activities directed to sourcing of necessary raw materials, producing, processing, packaging, labeling, quality assurance testing, release of a Licensed Product or Licensed Product candidate, whether for Development or Commercialization. When used as a verb, “Manufacture” means to engage in Manufacturing.

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

  • Manufacturing Process means any process for—

  • 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.

  • 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:

  • 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.

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

  • 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.

  • 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.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • 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 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, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • 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.

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • 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.

  • Commercial Product means any such product as defined in FAR 2.101.

  • 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.

  • 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;

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

  • Good Manufacturing Practices or “GMP” means, with respect to the United States, the minimum then-current good manufacturing practices for methods, facilities, and controls to be used for the manufacture, processing, packing, or holding of a drug to assure that it meets the requirements of the Federal Food, Drug, and Cosmetic Act for safety and has the identity and strength and meets the quality and purity characteristics, specified in 21 C.F.R. Parts 210 and 211, as may be amended, and, with respect to any other country or jurisdiction, the equivalent regulations in such other country or jurisdiction.

  • 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.

  • API means 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.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following: