FDA Application Integrity Policy definition

FDA Application Integrity Policy has the meaning set forth in Section 3.28(d).

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FDA Application Integrity Policy means the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy as stated at 56 Fed. Reg. 46191 (September 10, 1991);

FDA Application Integrity Policy is defined in Section 4.1(g)(ii).

Examples of FDA Application Integrity Policy in a sentence

Neither the Company nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.
Neither the Company nor any of its officers, employees, or, to the Company’s knowledge, any of its contractors or agents is the subject of any pending or threatened investigation by FDA pursuant to the FDA Application Integrity Policy and any amendments thereto, or by any other similar governmental entity pursuant to any similar policy.
Neither the Company nor its Subsidiaries, nor to the Knowledge of the Company, any of their respective officers, employees, contractors or agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke the FDA Application Integrity Policy or for any similar Governmental Authority to invoke a similar policy with respect to the Company or any Company Product.
Neither the Company nor any of its officers or employees, or, to the Company’s knowledge, any of the Company’s independent contractors or Agents or any its manufacturing or clinical service providers, has committed any act, made any statement, or failed to make any statement, in each case with respect to the Company, that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.
Neither the Corporation nor any of its officers, employees, contractors, and agents has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar governmental entity to invoke a similar policy.

More Definitions of FDA Application Integrity Policy

FDA Application Integrity Policy shall have the meaning ascribed to such term in Section 3.1(u).

FDA Application Integrity Policy is defined in Section ‎‎‎3.15.2.

FDA Application Integrity Policy is defined in Section 2.5.5.

FDA Application Integrity Policy is defined in Section 4.1(g)(ii). “First Commercial Sale” means the first sale by the Seller or any of its Affiliates or Licensees to an end user or prescriber for use, consumption, or resale of the Product in the Territory following receipt of Marketing Approval for the Product in the Territory. Dispositions of the Product in clinical trials or other scientific testing, as free samples, or prior to receipt of such Marketing Approval under named patient use, compassionate use, patient assistance, charitable purposes, or other similar programs or studies shall not be considered a First Commercial Sale to the extent such dispositions are made at or below cost. “GAAP” means generally accepted accounting principles in the United States in effect from time to time. “Governmental Entity” means any: (a) nation, principality, republic, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) U.S. federal, state, local, municipal, foreign or other government; (c) governmental or quasi-governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or other entity and any court, arbitrator or other tribunal); (d) multi-national organization or body; or (e) individual, body or other entity exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature. “Gross Sales” is defined in the definition of “Net Sales”. “Hard Cap” is defined in the definition of “Cap”. “Improvements” means any improvement, invention or discovery relating to the Product (other than with respect to a new composition of matter), including the formulation, or the method of manufacture of the Product. “In-License” means any license, settlement agreement or other agreement or arrangement between the Seller or any of its Affiliates and any Third Party pursuant to which the Seller or any of its Affiliates obtains a license or a covenant not to sue or similar grant of rights to any Patents or other intellectual property rights of such Third Party that is necessary for or used in the research, development, manufacture, use or Commercialization of the Product. “Indebtedness” of any Person means any indebtedness for borrowed money, any

FDA Application Integrity Policy has the meaning set forth in Section 1.1(a).

FDA Application Integrity Policy has the meaning specified in Section 5.31.

FDA Application Integrity Policy has the meaning set forth in Section 4.12(b) of this Agreement.