Commercial Manufacturing definition

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
Sample 1
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 [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
Sample 1

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.

  • When required, fences shall be erected around swimming pools according to the adopted Building Codes of the City.C. Fence Regulations for all Commercial, Manufacturing, and Redevelopment Districts.

  • 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 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.

  • These include traffic incidents such as crashes and vehicle breakdowns; work zones; bad weather; special events; and poorly timed traffic signals.

  • Tenth: Each share of stock shall be entitled to one vote on each matter submitted to vote at a meeting of shareholders.

  • Commercial Manufacturing Process809810 Applicants should provide — in Modules 3.2.P.2, 3.2.P.3, and 3.2.R — both details of the811 commercial manufacturing process and information to support the use of that particular process.

  • Ensuring that the spaces currently used for RSCA are of adequate quality should be a high priority.Improvements to research space will be a clear and tangible message to the faculty that research is important. The quality of collaborative research space must be improved.

  • 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).

  • Discussion and Action: (Reconsideration) An Ordinance amending Title 20 (Zoning) of the El Paso Municipal Code, by amending Chapter 20.02 (General Provisions and Definitions) to add 20.02.722 (Secondary Advertising Signs), and also by amending Chapter 20.66 (Signs), Sections 20.66.100 (Sign Permit Fee Formula), 20.66.130 (Prohibited Signs) and 20.66.300 (Commercial, Manufacturing, and Industrial Uses-C-1, C-2, C-3, C-4, M-1, M-2, {P-C, M-3 and Q Districts).


More Definitions of Commercial Manufacturing

Commercial Manufacturing means Manufacture of a Licensed Product (including the cost of API) or acquisition of such Licensed Product, in each case, for Commercialization of such Licensed Product in the Profit-Sharing Territory.
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Related to Commercial Manufacturing

  • 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.

  • 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, 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.

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

  • Distillery manufacturing license means a license issued in accordance with

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

  • 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 (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.

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

  • 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 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.