cGTPs definition
cGTPs means current Good Tissue Practices as described in Part 1271 of Title 21 of the U.S. Code of Federal Regulations.
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.
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).