cGTPs definition

cGTPs means current Good Tissue Practices as described in Part 1271 of Title 21 of the U.S. Code of Federal Regulations.
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cGTPs means current good tissue practices as specified in the Regulatory Laws of the applicable Regulatory Authority, as such Regulatory Laws are in effect at the time of manufacturing, including without limitation, Section 361 of the Public Health Services (PHS) Act (42 U.S.C. §264), as amended from time to time, and FDA tissue regulations, including 21 C.F.R. Part 1271, Subparts C and D, as revised from time to time.
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cGTPs means Current Good Tissue Practice regulations, as set forth in the United States Code of Federal Regulations Title 21 (21 CFR as may be amended from time to time, and any and all systems required to meet compliance therewith. If additional standards are intended to apply to this Agreement, they will be incorporated into the Specifications, the Quality Agreement or any other written agreement mutually agreed to by the Parties. The Parties agree that in the event that any Regulatory Authority having jurisdiction over the subject matter of cGTP standards, imposed standards applicable to Good Tissue Practices above the applicable standards that are established on the Effective Date (as defined below), which materially raise the cost of producing the Batches (the “New cGTP Standards”), ARC shall notify MacroCure of such cost increase and should MacroCure agree in writing to the implementation of the New cGCP Standards, ARC shall have the right to pass such costs along to MacroCure, at the cost including directly applicable G&A Expenses, but with no markup. If the changes are required by or for MacroCure in accordance with the foregoing and by or for any other clients of the ARC, the actual cost to ARC of the implementation of the New cGTP Standards (with no markup) shall be allocated between all such clients (including MacroCure) in an equitable manner. The G&A Expenses, in any event, shall not exceed ***** of the actual increase in the cost of production (excluding any applicable administrative and overhead costs).
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Related to cGTPs

  • Quality Management System means a set of interrelated or interacting elements that organisations use to direct and control how quality policies are implemented and quality objectives are achieved;

  • cGLP means the current good laboratory practice regulations promulgated by the FDA, published at 21 C.F.R. § 58, and all applicable FDA rules, regulations, orders and guidances and equivalent or comparable non-United States regulations, rules, orders, guidances and standards in the Territory, as applicable, as such current laboratory practices, rules, regulations, orders, guidances and standards may be amended from time to time.

  • GXP means any Point of Connection on the Grid:

  • PDMA means the Prescription Drug Marketing Act of 1987, as amended from time to time, together with any rules or regulations promulgated thereunder.

  • NRC means the United States Nuclear Regulatory Commission.

  • BPSS means the recognised standard for HMG for staff vetting which comprises verification of (1) identity, (2) employment history, (3) nationality and immigration status (including the right to work), and Criminal Records Bureau check (including a five (5) year address history check).

  • Quality system means documented organizational procedures and policies: internal audits of those policies and procedures: management review and recommendation for quality improvement.”

  • MPCA means the Minnesota Pollution Control Agency or Minnesota Pollution Control Agency staff as delegated by the Minnesota Pollution Control Agency.

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • WGS means the Whole Game System and the procedures for the operation thereof as determined by The FA from time to time.

  • IAEA means the International Atomic Energy Agency;

  • GCP means good clinical practices, which are the then-current standards for Clinical Trials for pharmaceuticals, as set forth in the FD&C Act or other Applicable Law, and such standards of good clinical practice as are required by the Regulatory Authorities of Europe and other organizations and governmental authorities in countries for which the applicable Licensed Agent or Product is intended to be Developed, to the extent such standards are not less stringent than United States standards.

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • Mobile crisis outreach team means a crisis intervention service for minors or families of minors experiencing behavioral health or psychiatric emergencies.

  • Quality Standards means the quality standards published by BSI British Standards, the National Standards Body of the United Kingdom, the International Organisation for Standardisation or other reputable or equivalent body, (and their successor bodies) that a skilled and experienced operator in the same type of industry or business sector as the Contractor would reasonably and ordinarily be expected to comply with, and as may be further detailed in the Specification.

  • NPS means nominal pipe size.

  • 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.

  • COVID-19 means SARS-CoV-2 or COVID-19, and any evolutions or mutations thereof or related or associated epidemics, pandemic or disease outbreaks.

  • MEPS means the New MAS Electronic Payment and Book-Entry System, as described in the Payment and Settlement Systems (Finality and Netting) (Designated System) (New MAS Electronic Payment and Book-Entry System) Order 2006;

  • CEMS means continuous emissions monitoring system.

  • Technology startup company means a for profit business that

  • Collaborative pharmacy practice means a practice of pharmacy whereby one or

  • Safety Management System has the meaning given to it in the ISM Code.

  • 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;

  • cGCP means the then current Good Clinical Practices that establish the national and international ethical and scientific quality standards for designing, conducting, recording and reporting clinical trials that are promulgated or endorsed for the United States by the FDA (including through ICH E6 and 21 CFR Parts 50, 54, 56 and 312) and for outside the United States by comparable Governmental Authorities.

  • Biodiesel blend means a fuel comprised of a blend of biodiesel fuel with petroleum-based diesel fuel, suitable for use as a fuel in a compression-ignition internal combustion diesel engine.