API means American Petroleum Institute.
Manufacturing Site means a location where a manufacturing
Manufacturing Process means any process for—
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 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 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.
Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:
SOPs has the meaning set forth in Section 3.7.
Study Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.
Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.
Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):
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.
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.
Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.
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 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.
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.
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.
Samples mean representative physical examples of materials, equipment or workmanship, used to confirm compliance with requirements and/or to establish standards for use in execution of the Work.
SAP Materials means any software, programs, tools, systems, data, or other materials made available by SAP or any other member of the SAP Group to Partner or to an End User (either directly or indirectly via Partner) prior to or in the course of the performance under any part of this Agreement including, but not limited to, the other SAP Products.
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.
Manufacturing Agreement has the meaning set forth in Section 2.6.
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.
Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.
Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;
Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.