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, council, or other government entity involved in regulating development of and granting regulatory approval for a pharmaceutical product, including the FDA and EMA.

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.

Examples of Regulatory Authority in a sentence

• Additionally, upon ▇▇▇▇▇▇’s request and at ▇▇▇▇▇▇’s expense, Evommune shall attend any meeting with any Regulatory Authority in the Territory regarding any Product in the Field, provided that Maruho provides Evommune with adequate advance written notice of such meeting.

• Additionally, ▇▇▇▇▇▇ shall keep the JSC reasonably and regularly informed in connection with the preparation of all Regulatory Materials, Regulatory Authority review of Regulatory Materials, Regulatory Approvals, and Pricing Approvals, in each case with respect to each Product in the Field in the Territory.

• Without limiting the foregoing, Maruho shall promptly (and, in any event, within [***] Business Days of receipt) provide to Evommune copies of any material documents or correspondence received from any Regulatory Authority related to Development Activities [***].

• Without limiting the generality of the foregoing, ▇▇▇▇▇▇ shall promptly inform Evommune of any inspections, proposed regulatory actions, investigations, or requests for information or a meeting by any Regulatory Authority with respect to the Products in the Field in the Territory.

• Without limiting the foregoing, upon request by Licensee shall promptly, but in any event within [***] Business Days after receipt of request, provide to copies of any material documents or correspondence received from any Regulatory Authority related to Development Activities.

More Definitions of Regulatory Authority

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 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 any applicable Government Authority responsible for granting Regulatory Approvals for Products, including the FDA, the EMA and any corresponding national or regional regulatory authorities.

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.

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

Regulatory Authority means any federal or state banking, other regulatory, self-regulatory or enforcement authority or any court, administrative agency or commission or other governmental authority or instrumentality.