FDA Permits definition

FDA Permits has the meaning set forth in Section 5.21(a).

FDA Permits shall have the meaning set forth in Section 3.05(b).

FDA Permits is defined in Section 4.24(a).

Examples of FDA Permits in a sentence

• The Company and its subsidiaries hold, and are operating in material compliance with, such Permits of the FDA and any other Regulatory Agency required for the conduct of their business as currently conducted (collectively, the “FDA Permits”), and all such FDA Permits are in full force and effect.

• The Company and its subsidiaries have fulfilled and performed all of their material obligations with respect to the FDA Permits, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any FDA Permit.

• The Company has fulfilled and performed all of its material obligations with respect to the FDA Permits, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any FDA Permit.

• The Company holds, and is operating in material compliance with, such Permits of the FDA and any other Regulatory Agency required for the conduct of its business as currently conducted (collectively, the “FDA Permits”), and all such FDA Permits are in full force and effect.

• In addi-tion, we assume that A pre-computes and stores the following values: K1 = eˆ(QB, sP ), K1′ = eˆ(Q′B, sP ).

More Definitions of FDA Permits

FDA Permits has the meaning given to such term in Section 5.12(b).

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 (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 all permits, licenses and approvals that are required under the FDA Laws for the operation of the Loan Parties’ business.

FDA Permits means all applicable certificates, authorizations, permits, registrations, clearances, approvals, and licenses issued, and exemptions (including 510(k) premarket notification and investigational device exemptions) authorized by the FDA and comparable state or foreign Governmental Bodies having equivalent authority over medical devices necessary to conduct its business and to research, develop, manufacture, process, produce, sell, market, distribute, transport, import and export its products.

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.