cGMP Sample Clauses

cGMP. Seller and its Affiliates shall Manufacture and supply the Products to Buyer at all times in full compliance with the Act, cGMP and any other applicable Regulatory Requirements. Seller and its Affiliates shall maintain during the Term of this Agreement and for a period thereafter consistent with Seller’s policies and standard cGMP requirements, all records as are necessary or appropriate to demonstrate compliance with the Act, cGMP and any other applicable quality control standards of any Regulatory Authority in the Territory. If Seller fails to comply with cGMPs in a manner, as demonstrated by an observation of a Regulatory Authority, Seller shall diligently proceed to remedy such deviation in accordance with Seller’s response to the observation.

cGMP. “cGMP” means those practices in the manufacture of pharmaceutical products that are recognized as the current good manufacturing practices by the FDA in accordance with FDA regulations, guidelines, other administrative interpretations, and rulings in connection therewith, including but not limited to those regulations cited in 21 C.F.R. parts 210 and 211, all as they may be amended from time to time.

cGMP. The term “cGMP” means current Good Manufacturing Practices as established by the FDA as the same may be amended from time to time.

cGMP. The manufacture of Product and/or Finished Devices shall be performed in accordance with cGMP and will meet the Specifications at the date of delivery.

cGMP. “CGMP” means those practices in the manufacture of pharmaceutical products that are recognized as the current good manufacturing practices by the FDA in accordance with FDA regulations, guidelines, other administrative interpretations, and rulings in connection therewith, including but not limited to those regulations cited in 21 C.F.R. parts 210 and 211, all as they may be amended from time to time.

cGMP. The Parties anticipate that there may be some phases of Construction that are ready for commencement before the GMP Amendment Date. In addition to the Advanced Packages set forth in Exhibit “B”, the DESIGN BUILD CONTRACTOR may recommend such phases or elements of the Construction (“Advance Packages”) to the Director, as appropriate, during performance of the Preconstruction Services. The Director shall have the sole discretion to authorize an Advance Package pursuant to this Section and Exhibit “B” but has no obligation to enter into any CGMP Amendment. Prior to any such authorization, the DESIGN BUILD CONTRACTOR shall provide the Director with a CGMP Submittal in accordance with Section 4.4 and Exhibit “F”.

cGMP. Sanofi-aventis shall manufacture the Products in accordance with cGMP. Each Party shall promptly notify the other of knowledge of any new instructions or specifications required in order to comply with cGMP, and shall cooperate in agreeing on the best means to comply with any new requirements.

cGMP. All Occam Items provided hereunder will meet all applicable regulatory requirements (including applicable cGMP regulations) imposed by applicable regulatory agencies with respect to any Approval;

cGMP. Supplier shall manufacture the API at the Facility in accordance with cGMP, the Specifications, the Quality Agreement and all laws, regulations and other legal requirements of Regulatory Authorities applicable to the manufacture of the API at the Facility. The initial Facility shall be located at 0000 X. Xxxxxxx Street, Springfield, Missouri 65807. Supplier shall be free, at any time, to change the Facility in which the API is manufactured to any other U.S-located facility that is owned or operated by Supplier and/or its Affiliates; provided, however, that Supplier will notify Customer at least [***] prior to such change. In the event Supplier changes the Facility pursuant to this Section 2.2, Customer shall have the right to revise the currently outstanding Forecast, including Firm Period, in order to reflect increased quantities of API and issue additional or revise currently outstanding Purchase Orders in order to reflect such increased quantities of API in order to obtain safety stock; provided that Supplier shall use commercially reasonable efforts to satisfy, but shall have no obligation to fulfill, any quantities in excess of [***] of the amount of API forecasted in the original Forecast.

cGMP. “CGMP” shall mean those practices in the manufacture of pharmaceutical products that are recognized as the current good manufacturing practices anywhere in the Territory, including but not limited to by the FDA in accordance with the FD&C Act and all applicable FDA regulations, guidelines, guidance documents, other administrative interpretations, and rulings in connection therewith, including but not limited to those regulations cited in 21 C.F.R. parts 210 and 211, all as they may be amended from time to time, as well as all applicable ICH guidelines and other regulatory documents relating to the manufacture of pharmaceutical products, in each case as any of the foregoing may be amended from time to time.