Certain FDA Matters Clause Samples

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. Except as disclosed in Schedule 2.23, there have been no product recalls or market withdrawals by the Company or any Subsidiary since December 31, 1995.

Certain FDA Matters. Pursuant to FDA’s existing PMA transfer procedure, Novoste shall (a) file with FDA an original and a copy of a letter (on Novoste’s letterhead and signed by a duly authorized Person) notifying FDA that all rights in the PMA Approval have been transferred to Purchaser and take such other appropriate actions consistent with its obligations pursuant to Section 11.8, and (b) provide Purchaser with a complete copy of the PMA Approval. Purchaser shall be responsible for all other steps necessary to perfect the transfer of the PMA Approval under FDA’s rules and procedures, including but not limited to, providing FDA with a written commitment to comply with conditions of approval applicable to the PMA Approval.

Certain FDA Matters. 15 2.24 Completeness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 ARTICLE III Representations and Warranties of the Purchaser

Certain FDA Matters. (i) As of the date hereof and as of the Effective Date, the Products are not and have not been adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act. As of the date hereof and as of the Effective Date, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged lack of safety or efficacy, or noncompliance, of any Product. As of the date hereof and as of the Effective Date, to BMS’ knowledge, there have been no warning or untitled letters, subpoenas, investigative demands, written inquiries, or seizures requested or threatened relating to the Products. As of the date hereof and as of the Effective Date, to BMS’ knowledge, there are no regulatory actions threatened in writing against any party that manufactures any component, ingredient, or material used in manufacturing any Product pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with BMS or any Selling Affiliates by the FDA or any Governmental or Regulatory Authority. (ii) As of the date hereof and as of the Effective Date, the manufacture of the Products by or on behalf of BMS or its Affiliates has been and is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA, including, as applicable, the FDA’s current Good Manufacturing Practices set forth in 21 C.F.R. Parts 210, 211 and 600. (iii) As of the date hereof and as of the Effective Date, each of BMS and its Affiliates subject to the King Settlement Agreement is and has been in compliance in all material respects with the terms thereof. (iv) As of the date hereof and as of the Effective Date, BMS and its Selling Affiliates have been and are in compliance in all material respects with all applicable Laws, regulations, orders, guidance, and policies administered or issued by FDA requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental or Regulatory Authority in each case to the extent related to the Products, including any post-approval commitments, and for the avoidance of doubt, the terms and conditions set forth in the January 17, 2008 approval letter for BL 125248, or any amendments thereto. (v) As of the date hereof and as of the Effective Date, none of BMS, its Selli...

Certain FDA Matters. (a) From and after the Closing Date, Buyers will store, ship, and otherwise handle all inventory transferred by Sellers to Buyers, pursuant to this Agreement, in compliance in all material respects with all applicable federal and state law, rules and regulations (including, without limitation those promulgated by the FDA where noncompliance could have a Material Adverse Effect on the Business acquired), provided, however, that the Buyers' representation and warranty under this Section 3.10(a) shall not apply to, and specifically excludes, any failure on the part of Buyers to so comply in any material respect with such applicable federal and state law, rules and regulations, which arises out of, or results from, any materially noncompliant condition that existed as of the Closing Date, and which noncompliance constitutes a breach of Sellers' representations and warranties. (b) The Buyers are 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 noncompliance in any material respect of the Parent and Superior with FDA, DEA and state regulatory requirements.

Certain FDA Matters. 19 SECTION 3.27.

Certain FDA Matters. Borrower certifies that its products, ------------------- operations and facilities, which are subject to regulation by the FDA, are in compliance with all relevant FDA requirements. Specifically, with respect to Borrower's products which require premarket notification (510(k)) clearance for legal commercial distribution in the United States, Borrower certifies that it holds its own 510(k) clearances for all of these products which it repackages, relabels or otherwise modifies. For those products requiring 510(k) clearance for which Borrower only acts as a distributor (private label or otherwise), Borrower certifies that the device manufacturer holds the necessary 510(k) clearances for the products and that Borrower does not engage in any activities relative to products, including, but not limited to, repackaging, relabeling, or other modification, that would cause it to need to hold its own 510(k) clearances for the products. As used herein, "repackaging" means packaging finished devices from bulk or repackaging an original manufacturer's devices into different containers (excluding shipping containers). As used herein, "relabeling" means changing the content of the labeling from that supplied by the original manufacturer (excluding merely adding Borrower's name).