Supply Manufacturing Definition definition

Supply Manufacturing Definition means the dimensional, mechanical and physical properties of the Stock Shape, as set forth in Exhibit C. Such Supply Manufacturing Definition may be changed or modified, amended or supplemented from time to time by Supplier upon giving not less than three months notice to Buyer;
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Supply Manufacturing Definition means the dimensional, mechanical and physical properties of the Stock Shape, as set out in Schedule 1, Part II;
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Supply Manufacturing Definition means the dimensional, mechanical and physical properties of the Stock Shape, as set forth in Exhibit C. Such Supply Manufacturing Definition may be changed, modified, amended or supplemented from time to time by Supplier upon giving not less than three months written notice to the Buyer. The Buyer shall be entitled, during that notice period, to place one final order for delivery at the earliest reasonably practicable date for a quantity of the Stock Shape manufactured to the Supply Manufacturing Definition then in force which shall be no greater than the total quantity of Stock Shape ordered by Buyer in the twelve (12) month period immediately prior to the notification date. ***Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.
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Examples of Supply Manufacturing Definition in a sentence

  • The batch shall meet the requirements of this Supply Manufacturing Definition when the results of these tests agree with the values shown below.

  • Buyer may reject all or any part of any consignment of Materials only on the grounds that it, or part of it does not conform to the Specification or Supply Manufacturing Definition (as the case may be) applicable on the date of manufacture and only by giving Supplier written notice of such rejection immediately on discovery of such lack of conformity, including full details of the reason for such rejection and in any event no later than [***] (“Warranty Notification Period”).

  • Buyer shall provide, within thirty (30) calendar days, a written confirmation that the Biomaterials of each shipment conform with the Specifications, or if applicable, that the Stock Shape of each shipment conforms with the Supply Manufacturing Definition.

  • If no such notice of rejection is given within thirty (30) calendar days of receipt of the shipment, Buyer shall be deemed to have accepted such delivery of Biomaterials or Stock Shape and acknowledged such Biomaterial’s conformance with the Specification or such Stock Shape’s conformance with the Supply Manufacturing Definition.

  • Supplier warrants to Buyer that Materials when manufactured shall conform in all material respects to the Specification or Supply Manufacturing Definition (as the case may be) as then in effect.

  • Buyer may reject all or any portion of any shipment of Biomaterials and/or Stock Shape if, and only if: (a) the Buyer reasonably believes such shipment is non–conforming in any material respect with (i) in the case of the Biomaterials, the Specification or (ii) in the case of the Stock Shape, the Supply Manufacturing Definition, and (b) the provisions of this Section 2.4 are satisfied.

  • The Buyer shall be entitled, during that notice period, to [***] for delivery at the earliest reasonably practicable date for a quantity of the Stock Shape manufactured to the Supply Manufacturing Definition then in force which shall be no greater than [***] meters.

Related to Supply Manufacturing Definition

  • 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.

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

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

  • Manufacturing Process means any process for—

  • 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 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.

  • 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 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.

  • 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 pharmacy practice agreement means a written and signed

  • 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.

  • 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;

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

  • 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.

  • Supply Plan has the meaning set forth in the CAISO Tariff.

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

  • health and safety specification means a site, activity or project specific document prepared by the client pertaining to all health and safety requirements related to construction work;

  • National Ambient Air Quality Standards or “NAAQS” means national ambient air quality standards that are promulgated pursuant to Section 109 of the Act, 42 U.S.C. § 7409.

  • 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.

  • Active Pharmaceutical Ingredient or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir alafenamide (“TAF”), tenofovir disoproxil fumarate (“TDF”), elvitegravir (“EVG”), and cobicistat (“COBI”).

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

  • 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.

  • Clinical Supply Agreement has the meaning set forth in Section 4.2.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Short-Term Resource Procurement Target means, for Delivery Years through May 31, 2018, as to the PJM Region, for purposes of the Base Residual Auction, 2.5% of the PJM Region Reliability Requirement determined for such Base Residual Auction, for purposes of the First Incremental Auction, 2% of the of the PJM Region Reliability Requirement as calculated at the time of the Base Residual Auction; and, for purposes of the Second Incremental Auction, 1.5% of the of the PJM Region Reliability Requirement as calculated at the time of the Base Residual Auction; and, as to any Zone, an allocation of the PJM Region Short-Term Resource Procurement Target based on the Preliminary Zonal Forecast Peak Load, reduced by the amount of load served under the FRR Alternative. For any LDA, the LDA Short-Term Resource Procurement Target shall be the sum of the Short-Term Resource Procurement Targets of all Zones in the LDA.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.