Regulatory Authority definition

Regulatory Authority means, with respect to any national, supra-national, regional, state or local regulatory jurisdiction, any agency, department, bureau, commission, council or other governmental entity involved in the granting of a Regulatory Approval for such jurisdiction.

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Regulatory Authority means any applicable supranational, national, regional, state or local regulatory agency, department, bureau, commission, counsel, or other government entity involved in granting of Regulatory Approval for a Licensed Product in a regulatory jurisdiction within the Territory, including the FDA and the EMEA.

Regulatory Authority means any applicable government regulatory authority involved in granting approvals for the marketing and/or pricing of a pharmaceutical product in a country or regulatory jurisdiction, including the FDA and foreign equivalents thereof.

Examples of Regulatory Authority in a sentence

• Notwithstanding such assignments, the Parties have not fully recorded such assignments with the applicable Regulatory Authority as of the date hereof.

• If requested by Sponsor, Company shall provide copies to Sponsor of any material report issued by the Regulatory Authority that is directly related to the Study to the extent permitted, including any FDA Form 483, warning letters, or other reports.

• Company shall promptly notify Sponsor of any material findings from any inspections or investigations by any Regulatory Authority regarding any facilities or procedures directly related to Services performed under this Agreement.

• Sponsor may, upon reasonable notice to Company, and on mutually agreed dates during normal business hours, inspect and review the facilities and procedures of Company and all books, records and other data directly related to the performance of any Services no more than once per twelve (12)-month period, unless (a) cause exists based on a material compliance concern, or (b) required by a Regulatory Authority.

More Definitions of Regulatory Authority

Regulatory Authority 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 Licensed Compound or Licensed Products in the Territory, including the FDA in the United States and the EMA in the European Union.

Regulatory Authority means, in a particular country or jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or jurisdiction.

Regulatory Authority means any governmental regulatory authority within a Territory involved in regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of the Product.

Regulatory Authority means, with respect to a country in the Territory, any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the EMA), regional, state or local regulatory agency, department, bureau, commission, council or other Governmental Authority involved in the granting of Regulatory Approvals or Price Approvals for pharmaceutical products in such country or countries.

Regulatory Authority means (a) the FDA, (b) the EMA or the European Commission, or (c) any regulatory body with similar regulatory authority over pharmaceutical or biotechnology products in any other jurisdiction anywhere in the world.

Regulatory Authority means any multinational, federal, national, state, provincial or local regulatory agency, department, bureau or other Governmental Authority with authority over the Development, Manufacture, or Commercialization of the Licensed Product in a country.

Regulatory Authority means the FDA or any counterpart of the FDA outside the United States, or other national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity with authority over the distribution, importation, exportation, manufacture, production, use, storage, transport, clinical testing or sale of a pharmaceutical product (including a Product), which may include the authority to grant the required reimbursement and pricing approvals for such sale.