Manufacturing Agreement has the meaning set forth in Section 2.6.
U.S. Special Resolution Regimes has the meaning specified in Section 11.21.
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.
Certificate of Catholic Practice means a certificate issued by the family’s parish priest (or the priest in charge of the church where the family attends Mass) in the form laid down by the Bishops’ Conference of England and Wales. It will be issued if the priest is satisfied that at least one Catholic parent or carer (along with the child, if he or she is over seven years old) have (except when it was impossible to do so) attended Mass on Sundays and holy days of obligation for at least five years (or, in the case of the child, since the age of seven, if shorter). It will also be issued when the practice has been continuous since being received into the Church if that occurred less than five years ago. It is expected that most Certificates will be issued on the basis of attendance. A Certificate may also be issued by the priest when attendance is interrupted by exceptional circumstances which excuse from the obligation to attend on that occasion or occasions. Further details of these circumstances can be found in the guidance issued to priests http://rcdow.org.uk/education/governors/admissions/
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 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.
Quality Agreement has the meaning set forth in Section 9.6.
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.
Model Articles means the model articles for private companies limited by guarantee contained in Schedule 2 of the Companies (Model Articles) Regulations 2008 (SI 2008/3229) as amended prior to the date of adoption of these Articles;
Distillery manufacturing license means a license issued in accordance with
Practice of medicine or osteopathic medicine means the prevention, diagnosis and treatment of
Commercial Supply Agreement has the meaning set forth in Section 4.1 (Supply Agreement).
Commercial sex act means any sex act on account of which anything of value is given to or received by any person.
Clinical Supply Agreement shall have the meaning set forth in Section 7.2.
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.
U.S. Special Resolution Regime means each of (i) the Federal Deposit Insurance Act and the regulations promulgated thereunder and (ii) Title II of the Xxxx-Xxxxx Xxxx Street Reform and Consumer Protection Act and the regulations promulgated thereunder.
Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture.
Development order means any order granting, denying, or granting with conditions an application for a development permit.
Commercial Development Plan means the written commercialization plan attached as Appendix E.
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.
Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.
Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.
service delivery and budget implementation plan means a detailed plan approved by the executive mayor of a municipality in terms of section 53(l)(c)(ii) of the MFMA for implementing the municipality's delivery of municipal services and its annual budget, and which must indicate
WTO GPA country construction material means a construction material that—
Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.
SOPs has the meaning set forth in Section 3.7.