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 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 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.
API means the 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.
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 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.
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, as applicable, current good manufacturing practices as described in:
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 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.
SAP Materials means any materials (including statistical reports) provided, developed or made available by SAP (independently or with Customer’s cooperation) in the course of performance under the Agreement, including in the delivery of any support or Professional Services to Customer. SAP Materials do not include the Customer Data, Customer Confidential Information or the Cloud Service. SAP Materials may also be referred to in the Agreement as “Cloud Materials”.
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.
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.