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. 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 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. 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. “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. 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. “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 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. Ista, and/or its Approved Third Party Contractor, shall manufacture the Product in accordance with cGMP and the Marketing Approval Application. Ista shall advise Allergan of any proposed process changes outside the Marketing Approval Application prior to implementing such changes.
cGMP. The term “cGMP” means all applicable standards relating to manufacturing practices for fine chemicals, intermediates, bulk products or finished pharmaceutical products including (i) ICH Q7a, U.S. cGMP 21CFR Parts 210 & 211, The Rules Governing Medicinal Products in the European Community, Volume IV Good Manufacturing Practice for Medicinal Products, and the principles detailed in the Japanese Pharmaceutical Affairs Law and Japanese Ministerial Ordinance 136, as each may be amended from time to time and (ii) statutes, rules, regulations or guidance documents (including but not limited to advisory opinions, compliance policy guides and guidelines) promulgated by any Regulatory Authority having jurisdiction over the manufacture of the Licensed Compound and the Products.
