cGCPs definition
cGCPs means current Good Clinical Practice regulations, as set forth in the United States Code of Federal Regulations Title 21 (21 C.F.R) 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 cGCP standards, imposed standards applicable to Good Clinical 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 cGCP 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 to the ARC, 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 cGCP 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).
cGCPs means current Good Clinical Practices, which is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
cGCPs means current good clinical practices as specified by the FDA.
More Definitions of cGCPs
cGCPs means the then-current standards, practices and procedures promulgated or endorsed by (i) the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the EU, (ii) the FDA as set forth in the guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA and (iii) the equivalent Laws in any relevant country, in each case, including all applicable rules, regulations, orders and guidance applicable thereto, and as each may be amended from time to time, and any successor thereto.