Common use of Certain FDA Matters Clause in Contracts

Certain FDA Matters. (a) Neither the Company nor Stockholder has made any untrue statement of a material fact or fraudulent statement to the FDA, failed to disclose a fact required to be disclosed to FDA, or committed any act, made any statement, or failed to make any statement that could provide a basis for 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). (b) Stockholder has provided to Parent for review, all correspondence to or from FDA, the U.S. Drug Enforcement Agency ("DEA") and any other state agency regulating the affairs of the Company (the "LOCAL AGENCIES"), minutes of meetings with FDA, the DEA and any Local Agency, any existing written reports of phone conversations, visits or other contracts with FDA, the DEA, and any Local Agency, notices of inspectional observations, establishment inspection reports, and all other documents in its possession concerning communications to or from FDA, the DEA and any Local Agency, (including without limitation any Form 482's issued by the FDA), or prepared by FDA, the DEA and any Local Agency which bear in any way on the Company's compliance with FDA, DEA and state regulatory requirements. (c) Stockholder has provided to Parent for review all documents reflecting conclusions, opinions, or suggestions of Company or Stockholder officers, employees, or agents, in-house or outside attorneys, or outside consultants, which bear in any way on the Company's compliance with FDA, DEA and state regulatory requirements. (d) Stockholder is not aware of any information, whether or not in written form, that it has not provided in the course of the review, which bears in any way on the Company's compliance with FDA, DEA and state regulatory requirements.

Certain FDA Matters. (a) Neither the The Company nor Stockholder has not made any untrue statement of a material fact or fraudulent statement to the FDA, failed to disclose a fact required to be disclosed to FDA, or committed any act, made any statement, or failed to make any statement that could provide a basis for FDA to invoke its policy respecting "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities," set forth in 56 Fed. Reg. Reg 46191 (September 10, 1991). (b) Stockholder The Company has provided to Parent for review, all correspondence to or from FDA, the U.S. Drug Enforcement Agency ("DEA") and any other state agency regulating the affairs of the Company (the "LOCAL AGENCIES"), minutes of meetings with FDA, the DEA and any Local Agency, any existing written reports of phone conversations, visits or other contracts with FDA, the DEA, and any Local Agency, notices of inspectional observations, establishment inspection reports, and all other documents in its possession concerning communications to or from FDA, the DEA and any Local Agency, (including without limitation any Form 482's issued by the FDA), or prepared by FDA, the DEA and any Local Agency which bear in any way on the Company's compliance with FDA, DEA and state regulatory requirements. (c) Stockholder The Company has provided to Parent for review of all documents reflecting conclusions, opinions, or suggestions of Company or Stockholder officers, employees, or agents, in-house or outside attorneys, or outside consultants, which bear in any way on the Company's compliance with FDA, DEA and state regulatory requirements. (d) Stockholder The Company is not aware of any information, whether or not in written form, that it has not provided in the course of the review, which bears in any way on the Company's compliance with FDA, DEA and state regulatory requirements.

Certain FDA Matters. (a) Neither the Company nor Stockholder has The Sellers have not made any untrue statement of a material fact or fraudulent statement to the FDA, failed to disclose a fact required to be disclosed to the FDA, or committed any act, made any statement, or failed to make any statement that could 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. Reg 46191 (September 10, 1991). (b) Stockholder The Business has provided to Parent for review, all correspondence to or from the FDA, the U.S. Drug Enforcement Agency ("DEA") DEA and any other state agency regulating the affairs of the Company Business (the "LOCAL AGENCIES"), minutes of meetings with the FDA, the DEA and any Local Agency, any existing written reports of phone conversations, visits or other contracts with FDA, the DEA, and any Local Agency, notices of inspectional observations, establishment inspection reports, and all other documents in its possession concerning communications to or from the FDA, the DEA and any Local Agency, (including without limitation any Form 482's issued by the FDA), or prepared by the FDA, the DEA and any Local Agency which bear in any way on the Company's compliance of the Business with FDA, DEA and state regulatory requirements. (c) Stockholder The Business has provided to Parent for review all documents reflecting conclusions, opinions, or suggestions of Company or Stockholder officersany Limited Partners, General Partners, employees, or agents, in-house or outside attorneys, or outside consultants, which bear in any way on the Company's compliance of the Business with FDA, DEA and state regulatory requirements. (d) Stockholder The Business is not aware of any information, whether or not in written form, that it has not provided in the course of the review, which bears in any way on the Company's compliance of the Business with FDA, DEA and state regulatory requirements.