Regulatory Permits definition

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

Regulatory Permits means all licenses, waivers, permits, enrollments, certifications, authorizations, approvals, franchises, registrations, accreditations, letters of non-reviewability, certificates of need, consents, supplier or provider numbers, qualifications, operating authority, and other such Permits granted by any such Governmental Entity to any Group Company.

Regulatory Permits means all Permits granted by FDA or any comparable Governmental Entity to any Group Company, 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.

Examples of Regulatory Permits in a sentence

• Except as could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, hold and operate in material compliance with, Regulatory Permits issued by the FDA or other Governmental Authority required for the conduct of its business as currently conducted.

More Definitions of Regulatory Permits

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

Regulatory Permits means governmental licenses, franchises, permits, certificates, consents, approvals, clearances, exemptions, registrations, listing, concessions or other authorizations required to have been obtained from, or filings required to have been made with, Governmental Authorities pursuant to a Health Law in order to allow the conduct of a regulated activity.

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