Common use of No False Statements Clause in Contracts

No False Statements. Neither the Seller nor any Seller Predecessor, and no officer, employee or agent of the Seller or any Seller Predecessor, has (i) made any false statement or failed to disclose a material fact in the applications, approvals, reports or other submissions to the FDA or other Regulatory Authority in the United States, Canada or the European Union or in any other records and documentation prepared or maintained to comply with the requirements of the FDA or other Regulatory Authorities relating to Aeroquin, or (ii) committed an act, made a statement or failed to make a statement that (in any such case) would reasonably be expected to establish a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the EMA or any similar state or non-United States Regulatory Authority in the United States, Canada or the European Union to invoke any similar policy. The Seller has not, and, to the Knowledge of the Seller, no Seller Predecessor, no Representative of the Seller and no principal investigator or sub-investigator of any clinical investigation sponsored by the Seller or any Seller Predecessor has, on account of actions taken for or on behalf of the Seller or any Seller Predecessor, been convicted of any crime under 21 U.S.C. Section 335a(a) or any similar state or non-United States Legal Requirement or under 21 U.S.C. Section 335a(b) or any similar state or non-United States Legal Requirement.