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 Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.
Latent Defects means such defects caused by faulty designs, material or work-man- ship which cannot be detected during inspection, testing etc, based on the technology available for carrying out such tests.
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.
API means American Petroleum Institute.
Nonconformance as used in this clause means a condition of any hardware, software, material, or service/workmanship in which one or more characteristics do not conform to requirements.
Investigational Medicinal Product means the study drug or control material as defined in the Protocol.
Manufacturing Process means any process for—
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;
Latent Defect means a defect, inherently lying within the material or arising out of design deficiency, which do not manifest themselves and/or was not reasonably discoverable during Defect Liability period.
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.
Product Specification means a product specification for a Medical Device set out in Schedule 2;
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.
Product Warranty has the meaning set forth in Section 9.3.
Defective Product has the meaning set forth in Section 5.2.
cGMPs means current good manufacturing practices as described in Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations, together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;
Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;
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.
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;
Manufacturing Site means a location where a manufacturing
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.
Manufacturer’s Warranty means the warranty supplied from time to time by the manufacturer of the Goods as at the date of the acceptance of the Statement of Work; “PPSA” means the Personal Property Securities Xxx 0000; “Price” means the amount specified within each Statement of Work (subject to any Variation) or as otherwise specified from the Company to the Customer representing the cost for the Works; “Related Work” means any additional building, carpentry, painting, plastering, plumbing or other work or other trades that the Customer requires, which are not to be carried out by the Company; “Services” means the services provided by the Company to the Customer as part of the Works, which may include without limitation the installation of Goods; “Services Delay Charge” means the services delay charge (if any) set out in the Statement of Work; “Services Interruption Event” means any interruption to a Works caused by; a Force Majeure Event, the Customer’s failure to carry out or perform any obligation required of it under this agreement which in the sole opinion of the Company does or may cause a delay in the Works and any other matter which in the reasonable opinion of the Company will cause an interruption or delay in the performance of the Works; “Statement of Work” means the details outlining the provision of the Works, which statement can be delivered verbally or in writing (including email) and may include (where applicable) an estimate or quotation (as specifically expressed as the case) of costs; “Variation” means a change in the Statement of Work including the specifications, scope, time of supply, price or scale of the Works and such variation shall form part of this agreement; “Workmanship” means a good and high quality and standard of delivery in connection with the Services performed; “Works” means the supply of Goods and the provision of Services to the Customer as per each Statement of Work;
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.
Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.
Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.
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.