Regulatory Permits definition

Regulatory Permits means all Permits granted by the FDA or any comparable Governmental Entity to the Company or any of its Subsidiaries, including investigational new drug applications, Biologics License Applications, manufacturing approvals and authorizations, clinical trial authorizations and ethical reviews, or their national or foreign equivalents.

Regulatory Permits means all licenses, permits, certificates, franchises, ordinances, registrations, qualifications, and other rights, privileges, applications or authorizations filed with, granted or issued by the Securities Exchange Commission, any state securities or blue sky regulatory authority in which the Company maintains offices, FINRA or any self-regulatory organization.

Regulatory Permits has the meaning assigned to it in Section 4.27 hereof.

Examples of Regulatory Permits in a sentence

• To the knowledge of the Company, (i) no Governmental Entity is considering limiting, suspending or revoking any Regulatory Permit held by the Company or any of its Subsidiaries, if any, and (ii) each third party that is a manufacturer, contractor or agent for the Company or any of its Subsidiaries is in compliance in all material respects with all Regulatory Permits, if any, and all applicable Healthcare Laws insofar as they pertain to the Company Products.

• The Company and the Subsidiaries are in compliance in all material respects with the requirements of the Permits and the Regulatory Permits, and all of such Regulatory Permits are valid and in full force and effect.

• Each of the Group Companies has all material Permits (including Regulatory Permits) that are required to own, lease or operate its properties and assets and to conduct its business as currently conducted (the “Material Permits”), except where the failure to hold the same would not have a Company Material Adverse Effect.

More Definitions of Regulatory Permits

Regulatory Permits has the meaning set forth in Section 3.1(k)(i).

Regulatory Permits all Permits granted by FDA or any comparable Governmental Authority to the Company or its Subsidiaries, including investigational new drug applications, new drug applications, abbreviated new drug applications, medical device or in vitro diagnostic premarket approval applications, medical device or in vitro diagnostic premarket clearances (e.g., 510(k) clearances), investigational device exemptions, and other comparable national or foreign manufacturing approvals and authorizations.

Regulatory Permits has the meaning set forth in Section 3.1.40(b).

Regulatory Permits means all Permits issued or required under applicable Health Care Laws.

Regulatory Permits means authorization (i) under the FDCA or the Public Health Service Act and (ii) of any applicable Regulatory Agency, in each case, as necessary for the lawful operation of the business of the Company or any of its Subsidiaries.

Regulatory Permits shall have the meaning ascribed to such term in Section 3.1(gg)(ii).

Regulatory Permits means all Permits granted by any Healthcare Regulatory Authority or comparable Governmental Entity and/or notified bodies, including biomarker qualification determinations, drug development tool qualifications, investigational new drug applications, new drug applications, abbreviated new drug applications, device premarket approval applications, device premarket notifications, EC certificates, EC declarations of conformity, investigational device exemptions, and other comparable national or foreign manufacturing approvals and authorizations.