Regulatory Acts definition

Regulatory Acts means, as applicable, the United States Federal Food, Drug and Cosmetic Act, as amended, the rules and regulations thereunder, and any other laws and regulations governing the approval, manufacture, sale or licensing of pharmaceutical products or ingredients for inclusion applicable to the Products.

Regulatory Acts means any rules, regulations, directives, decisions, ordinances, guidelines and other pronouncements of any Regulatory Authority.

Regulatory Acts means (a) the Texas Pawnshop Act, (b) the Consumer Credit Act 1974 enacted in the United Kingdom and (c) all other forxxxx, Xxderal or state laws (statutory, administrative, judicial or otherwise) relating to pawnshops and activities incidental thereto.

Examples of Regulatory Acts in a sentence

• To produce Products under this Agreement, GSK will obtain Materials and API raw materials and intermediates (identified on Schedule 4.6(c)) only from suppliers named in the Specifications, where applicable, and shall store, maintain, test and release, as applicable, all Materials, and API raw materials and intermediates (identified on Schedule 4.6(c)) in accordance with the applicable Specifications, the Quality Agreement, and as otherwise required by cGMPs, Applicable Laws and Regulatory Acts.

• Upon receipt of Consents by Prometheus or its Third Party Supplier, the manufacture, packaging, processing, storage, disposal, transportation and other handling of Products by Prometheus or its Third Party Supplier shall be in accordance with and conform to the Specifications, cGMPs, Applicable Laws, the Quality Agreement and Regulatory Acts.

• The manufacture, packaging, processing, storage, disposal and other handling of the Products and the API by GSK until Delivery to Prometheus' designated carrier or freight forwarder at the Facility shall be in accordance with and conform to the Specifications, cGMPs, Applicable Laws, Regulatory Acts and the Quality Agreement.

• Prior to release of Product to finished goods inventory or release for Delivery to Prometheus, GSK shall test the Products for Nonconformities (as defined below), in accordance with the testing procedures described in the Specifications and the Quality Agreement and as otherwise required by cGMPs, Applicable Laws and Regulatory Acts.

• During the Term of this Agreement, Prometheus shall have the right to audit and inspect those portions of the Facility used in the manufacture, packaging, storage, testing, holding, distribution or other handling, receiving or invoicing of the Products and Materials for the sole purposes of ensuring compliance with the Specifications and the Quality Agreement, and, as related to the Products and Materials, each of cGMPs, Applicable Laws, and Regulatory Acts.

More Definitions of Regulatory Acts

Regulatory Acts means, subject to paragraph (3), any:

Regulatory Acts means the Federal Power Act, Holding Company Act, Chapters 1 through 4A of Title 46 of the Official Code of Georgia, and all other Federal or state laws relating to public utilities or the generation, transmission, production or sale of electric power or steam energy.

Regulatory Acts means acts of general applicability2: for the EU:

Regulatory Acts means all applicable laws and regulations of any of the countries in the Licensed Territory that govern the approval, manufacture, sale or licensing of pharmaceutical products, or ingredients for inclusion therein, including, without limitation, the United States Federal Food, Drug and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder.

Regulatory Acts means, as applicable, the FDCA, the rules and regulations thereunder, and any Applicable Laws and regulations governing the approval, manufacture, sale or licensing of pharmaceutical products or ingredients for inclusion therein of any other jurisdiction for which Grifols is then producing products.

Regulatory Acts means, as applicable, the United States Federal Food, Drug and Cosmetic Act, as amended, the rules and regulations thereunder, and any applicable laws and regulations governing the approval, manufacture, sale or licensing of sipuleucel-T or ingredients for inclusion therein of any other jurisdiction in the Territory for which GSK is then producing Product.

Regulatory Acts means, as applicable, the Canadian Food and Drug Act, as amended, the rules and regulations thereunder, and any applicable laws and regulations governing the approval, manufacture, sale or licensing of pharmaceutical products or ingredients for inclusion therein of any other jurisdiction named on Schedule 2.1 to the applicable Specific Product Supplement, as each such Schedule is amended from time to time, for which Draxis is then producing Products.