Regulatory Authority(ies) definition

Regulatory Authority(ies) means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory agencies, departments, bureaus, commissions, councils, or other government entities (e.g., the FDA and EMA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Development of a Licensed Compound in the Territory.

Regulatory Authority(ies) means any governmental authority in a country or region that regulates the manufacture or sale of Company’s products, including, but not limited to, the United States Food and Drug Administration.

Regulatory Authority(ies) means any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in each country of the world involved in the reviewing, granting or revoking of Regulatory Approvals for the Diagnostic Test.

Examples of Regulatory Authority(ies) in a sentence

• Are There Any Differences Between the Powers of the National Regulatory Authority(ies) and Courts in Relation to Cases Dealt with under Article 101 and/or Article 102 of the TFEU, and Those Dealt with Only under National Law.

• Before implementation, the amendment should be submitted and approved by applicable IRBs/ECs and, if required by the Regulatory Authority(ies).

• Celltech shall, as soon as practical after receipt of Product into Consignment Inventory or from other than Consignment Inventory, examine the Product for any apparent non-conformance and carry out or have carried out, routine laboratory testing and other chemical analysis of the Product as required by the relevant Marketing Authorizations and/or Regulatory Authority(ies).

• Licensee shall permit the Regulatory Authority(ies) in the Exelixis Territory to conduct inspections of Licensee, its Affiliates, and acting reasonably and in good faith of Sublicensees or subcontractors (including Clinical Trial sites) relating to the Development of the Product under the GDP, and shall ensure that such Affiliates, and acting reasonably and on good faith, such Sublicensees and subcontractors permit such inspections.

• Exelixis shall permit the Regulatory Authority(ies) in the Licensee Territory to conduct inspections of Exelixis, its Affiliates, and acting reasonably and in good faith of Sublicensees or subcontractors (including Clinical Trial sites) relating to the Development of the Product under the GDP for the Licensee Territory, and shall ensure that such Affiliates, and acting reasonably and on good faith, such Sublicensees and subcontractors permit such inspections.

More Definitions of Regulatory Authority(ies)

Regulatory Authority(ies) means any government authority of any type that has any direct or indirect control of any regulation or government rule, law, regulation, or the ability to grant, deny, or exert any control over Regulatory Approvals or implementation thereof in any jurisdiction.

Regulatory Authority(ies) means the FDA in the U.S., and any health regulatory authority(ies) in any country in the Territory that is a counterpart to the FDA and holds responsibility for granting regulatory marketing approval for the Product in such country, and any successor(s) thereto as well as any state or local health regulatory authorities having jurisdiction for any activities contemplated by the Parties.

Regulatory Authority(ies) means the PUCT, the Electric Reliability Council of Texas, the Texas Regional Entity, any governmental agency having jurisdiction over the Company or its assets (including a System) and any self-regulatory organization, including, without limitation, a national securities exchange registered with the Securities and Exchange Commission.

Regulatory Authority(ies) means the FDA (for the USA), EMA (for the EU), ANVISA (for Brazil), MHRA (for the UK), and/or all other applicable, national, multi-national, state, regional or local regulatory agency, department, bureau, body or other governmental entity involved in or responsible for regulation of the relevant subject, as the context requires in this Agreement. Notwithstanding the foregoing, Regulatory Authorities shall include the relevant health, environmental, and safety agency pertaining to the country in which Manufacturing Services are performed.

Regulatory Authority(ies) means any regulatory authority, agency, department, bureau, or other governmental entity, including the FDA and corresponding foreign authorities, which is responsible for issuing approvals, licenses, registrations, clearances, or authorizations necessary for the Development, registration, Manufacture, testing, formulation, assembly, packaging, labelling, use, receipt, shipment, storage, import, export, transport, Commercialization, Promotion, marketing, distribution or sale of the Product in a country.

Regulatory Authority(ies) means any Governmental Authority or other authority responsible for granting Regulatory Approvals for the Product, including the FDA and any corresponding national or regional regulatory authorities.

Regulatory Authority(ies) means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of Product thereto in the Territory, including the FDA.