No False Statements. The Grantee warrants that the internal financial statements provided to NMED by the Grantee for approval do not contain false material statements, representations, certifications, or omissions of material fact.
No False Statements. Neither the Company, nor any officer, employee, or agent of the Company, has committed an act, made a statement or failed to make a statement, that (in any such case) that is prohibited under the FDA’s policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991).
No False Statements. The Company represents and warrants, as of the Effective Date, the Company has not knowingly made any false statements to the City regarding, or failed to provide any information required by Ohio Revised Code Section 9.66(B) concerning, an application for economic development assistance in connection with this Agreement.
No False Statements. The Grantee warrants that the internal financial statements provided to NMED by the Grantee for approval do not contain false material statements, representations, certifications, or omissions of material fact.
I. NEPA For any phase of the Project which requires National Environmental Policy Act (NEPA) review, NMED shall not disburse any funds for that phase until the appropriate NEPA review is completed.
No False Statements. As of the date hereof, neither any Borrower Financing Document nor any other document, certificate or statement furnished to the Issuer or the Bank by or on behalf of the Borrower contains any untrue statement of a material fact with respect to the Borrower or omits to state a material fact with respect to the Borrower necessary in order to make the statements contained herein and therein not misleading. It is specifically understood by the Borrower that all such statements, representations and warranties shall be deemed to have been relied upon by the Issuer as an inducement to make the Loan and issue the Bond and by the Bank to purchase the Bond.
No False Statements. Except as set forth in Schedule 3.1(r), the Company has not made any material false statement in, or material omission from, the applications, approvals, reports, or other submissions to the FDA or other Governmental Authorities or in or from any other records and documentation prepared or maintained to comply with the requirements of the FDA or other Governmental Authorities relating to any Product, including any CE Marking certifications, 510(k)s, PMAs, IDEs, Consents from Ethics Committees, vigilance reports, line extension letters, documentation of safety and efficacy, studies or documentation of equivalency, Product labeling, device history records, certificates of export, or MDRs.
No False Statements. Neither the Company nor any officer, employee or agent of the Company has made an untrue statement of a material fact or fraudulent statement to the FDA or any other governmental entity, failed to disclose a material fact required to be disclosed to the FDA or any other governmental entity, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, in each case, relating to Company’s business, could reasonably be expected to provide a basis for the FDA or any other governmental entity to invoke any policies respecting Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities, including but not limited to the FDA policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. The Company has not been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar law for which debarment is authorized by 21 U.S.C. § 335a(b) or any similar law.
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.
No False Statements. No exhibit, report, document or certificate furnished or to be furnished by the Corporation to PPD in connection with this Agreement contains or will contain any false or misleading statement or representation of a material fact or figure or omit or will omit any material fact or statement.
No False Statements. Neither Party will, with respect to any activities conducted under this Agreement, (a) commit an act, (b) make a statement, or (c) fail to act or make a statement, in any case ((a), (b), or (c)), that (i) would be or create an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the exercise of the rights granted to Licensee under the Licensor Technology or the Exploitation of any Licensed Compound or Licensed Product, or (ii) could reasonably be expected to provide 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) and any amendments thereto or any analogous laws or policies in any country in the Territory, with respect to the exercise of the rights granted to Licensee under the Licensor Technology or the Exploitation of any Licensed Compound or Licensed Product. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
