FDA Permits has the meaning set forth in Section 5.21(a).
FDA Permits has the meaning set forth in Section 3.17(a).
FDA Permits as defined in Section 4.30(a).
Examples of FDA Permits in a sentence
This Section 4.12 does not cover FDA Permits, which are covered solely by Section 4.13.
The Company and the Company Subsidiaries have fulfilled and performed in all material respects all of their obligations with respect to the FDA Permits.
More Definitions of FDA Permits
FDA Permits means all Permits (including, for the avoidance of doubt, all establishment registrations, device listings and 510(k) clearances) required by the FDA (or any other Health Authority).
FDA Permits means (i) all Premarket Approval Applications submitted to the FDA, (ii) Premarket Notifications submitted under Section 510(k) to the FDA, (iii) all Investigational Device Exemptions or Clinical Trial Applications submitted to the FDA or to any other Governmental Authority, (iv) all Marketing Authorization Applications submitted to the EMA and its respective counterparts in the European Union, and (v) all foreign counterparts to any of the foregoing.
FDA Permits means all permits, licenses and approvals that are required under the FDA Laws for the operation of the Loan Parties’ business.
FDA Permits means any permits, licenses, approvals, clearances, registrations, certifications, or other investigational or marketing authorizations issued or obtained pursuant to an FDA Law, including FDA-approved biologics license applications (“BLA”), new drug applications (“NDA”), abbreviated new drug applications (“ANDA”), medical device premarket clearances (“510(k)”), medical device premarket approvals (“PMA”), investigational new drug (“IND”) and investigational device exemption (“IDE”) applications, National Drug Codes (“NDC”), FDA establishment registrations, controlled substance licenses, and local, state, federal, and foreign manufacturing, wholesale and distribution-related permits.
FDA Permits means Permits required by the FDA for the conduct of the Business as currently conducted and continuing until the Closing Date, including registrations under sections 351 or 361 of the Public Health Service Act, pre-market notifications under section 510(k) of the U.S. Federal Food, Drug and Cosmetic Act (21 U.S.C. § 360(k)) (“510(k)s”), as well as all supplements and amendments that may be filed with respect to the foregoing.
FDA Permits shall have the meaning set forth in Section 4.01(n)(7).
FDA Permits has the meaning ascribed to such term in Section 8(i) of this Agreement;