Certain FDA Matters Sample Clauses

Certain FDA Matters. Neither the Company nor any of the Subsidiaries, nor, to the knowledge of the Company, any of its or any of the Subsidiaries’ officers, directors or managing employees (as defined in 42 U.S.C. § 1320a-5(b)), is or has been excluded, suspended or debarred from participation in any Federal Health Care Program, (as defined at 42 U.S.C. §1320a-7(b)(f)), debarred by FDA or comparable authorities pursuant to 21 U.S.C. § 335a or similar laws, or made subject to any pending or, to the knowledge of the Company, threatened action which could reasonably be expected to result in such exclusion, suspension or debarment.
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Certain FDA Matters. (a) 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 46191 (September 10, 1991).
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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.
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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.
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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.
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Certain FDA Matters. 15 2.24 Completeness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 ARTICLE III Representations and Warranties of the Purchaser
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Certain FDA Matters. 19 SECTION 3.27.
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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).
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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.
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Related to Certain FDA Matters

  • Certain Matters Any provision herein to the contrary notwithstanding, the Company shall not be obligated pursuant to the terms of this Agreement to indemnify Indemnitee on account of any proceeding with respect to (i) remuneration paid to Indemnitee if it is determined by final judgment or other final adjudication that such remuneration was in violation of law (and, in this respect, both the Company and Indemnitee have been advised that the Securities and Exchange Commission believes that indemnification for liabilities arising under the federal securities laws is against public policy and is, therefore, unenforceable and that claims for indemnification should be submitted to appropriate courts for adjudication, as indicated in Section 10(d) below); (ii) a final judgment rendered against Indemnitee for an accounting, disgorgement or repayment of profits made from the purchase or sale by Indemnitee of securities of the Company against Indemnitee or in connection with a settlement by or on behalf of Indemnitee to the extent it is acknowledged by Indemnitee and the Company that such amount paid in settlement resulted from Indemnitee’s conduct from which Indemnitee received monetary personal profit, pursuant to the provisions of Section 16(b) of the Securities Exchange Act of 1934, as amended, or other provisions of any federal, state or local statute or rules and regulations thereunder; (iii) a final judgment or other final adjudication that Indemnitee’s conduct was in bad faith, knowingly fraudulent or deliberately dishonest or constituted willful misconduct (but only to the extent of such specific determination); or (iv) on account of conduct that is established by a final judgment as constituting a breach of Indemnitee’s duty of loyalty to the Company or resulting in any personal profit or advantage to which Indemnitee is not legally entitled. For purposes of the foregoing sentence, a final judgment or other adjudication may be reached in either the underlying proceeding or action in connection with which indemnification is sought or a separate proceeding or action to establish rights and liabilities under this Agreement.

  • FDA Matters (a) The Corporation has (i) complied in all material respects with all applicable laws, regulations and specifications with respect to the manufacture, design, sale, storing, labeling, testing, distribution, inspection, promotion and marketing of all of the Corporation’s products and product candidates and the operation of manufacturing facilities promulgated by the U.S. Food and Drug Administration (the “FDA”) or any corollary entity in any other jurisdiction and (ii) conducted, and in the case of any clinical trials conducted on its behalf, caused to be conducted, all of its clinical trials with reasonable care and in compliance in all material respects with all applicable laws and the stated protocols for such clinical trials.

  • Certain Environmental Matters (i) The Company and its subsidiaries (x) are in compliance with all, and have not violated any, applicable federal, state, local and foreign laws (including common law), rules, regulations, requirements, decisions, judgments, decrees, orders and other legally enforceable requirements relating to pollution or the protection of human health or safety, the environment, natural resources, hazardous or toxic substances or wastes, pollutants or contaminants (collectively, “Environmental Laws”); (y) have received and are in compliance with all, and have not violated any, permits, licenses, certificates or other authorizations or approvals required of them under any Environmental Laws to conduct their respective businesses; and (z) have not received notice of any actual or potential liability or obligation under or relating to, or any actual or potential violation of, any Environmental Laws, including for the investigation or remediation of any disposal or release of hazardous or toxic substances or wastes, pollutants or contaminants, and have no knowledge of any event or condition that would reasonably be expected to result in any such notice, and (ii) there are no costs or liabilities associated with Environmental Laws of or relating to the Company or its subsidiaries, except in the case of each of (i) and (ii) above, for any such matter as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; and (iii) except as described in each of the Pricing Disclosure Package and the Prospectus, (x) there is no proceeding that is pending, or that is known to be contemplated, against the Company or any of its subsidiaries under any Environmental Laws in which a governmental entity is also a party, other than such proceeding regarding which it is reasonably believed no monetary sanctions of $100,000 or more will be imposed, (y) the Company and its subsidiaries are not aware of any facts or issues regarding compliance with Environmental Laws, or liabilities or other obligations under Environmental Laws or concerning hazardous or toxic substances or wastes, pollutants or contaminants, that could reasonably be expected to have a material effect on the capital expenditures, earnings or competitive position of the Company and its subsidiaries, and (z) none of the Company or its subsidiaries anticipates material capital expenditures relating to any Environmental Laws.

  • Certain ERISA Matters (a) Each Lender (x) represents and warrants, as of the date such Person became a Lender party hereto, to, and (y) covenants, from the date such Person became a Lender party hereto to the date such Person ceases being a Lender party hereto, for the benefit of, the Administrative Agent and not, for the avoidance of doubt, to or for the benefit of the Borrower or any other Loan Party, that at least one of the following is and will be true:

  • Certain Additional Matters (a) Any arbitration award shall be a bare award limited to a holding for or against a party and shall be without findings as to facts, issues or conclusions of law (including with respect to any matters relating to the validity or infringement of patents or patent applications) and shall be without a statement of the reasoning on which the award rests, but must be in adequate form so that a judgment of a court may be entered thereupon. Judgment upon any arbitration award hereunder may be entered in any court having jurisdiction thereof.

  • Certain Legal Matters The choice of laws of the State of New York as the governing law of this Agreement and the Deposit Agreement is a valid choice of law under the laws of Canada and may be honored by courts located in Canada. The Company has the power to submit, and pursuant to Section 9.7 of this Agreement, has legally, validly, effectively and irrevocably submitted, to the non-exclusive jurisdiction of the courts provided for in Section 9.7 hereof, and service of process effected in the manner provided for in Section 9.7 will be effective to confer valid personal jurisdiction over the Company as provided therein. Except as disclosed in the Disclosure Package and the Prospectus, any final judgment for a fixed sum of money rendered by a New York Court having jurisdiction under its own domestic laws in respect of any suit, action or proceeding against the Company based upon this Agreement or the Deposit Agreement may be recognized and enforced by courts located in Canada. There is no bilateral arrangement between Canada and the United States for the recognition of foreign judgments, however the laws of Canada permit an action to be brought in a court of competent jurisdiction in Canada to recognize and declare enforceable a final and conclusive judgment of a New York Court of a sum certain against and respecting the obligations of the Company under this Agreement or the Deposit Agreement that is not impeachable as void or voidable under the internal laws of the State of New York, provided that such Canadian court is satisfied that (i) the parties to the proceeding enforcing the judgment of the New York Court are identical to those in the original New York Court proceedings; (ii) the New York Court issuing the judgment exercised jurisdiction which Canadian courts recognize had jurisdiction in the matter, and the Company either submitted to such jurisdiction or was resident or carrying on business within such jurisdiction and was duly served with process; (iii) the judgment given by the New York Court was not in respect of penalties, taxes, fines or similar fiscal or revenue obligations of the Company; (iv) in obtaining judgment there was no fraud on the part of the person in whose favor judgment was given or on the part of the New York Court; (v) recognition or enforcement of the judgment in Canada would not be contrary to public policy; and (vi) the proceedings pursuant to which judgment was obtained were not contrary to natural justice.

  • Certain Corporate Matters VSCO is duly licensed or qualified to do business and is in good standing as a foreign corporation in every jurisdiction in which the character of VSCO’s properties or nature of VSCO’s business requires it to be so licensed or qualified other than such jurisdictions in which the failure to be so licensed or qualified does not, or insofar as can reasonably be foreseen, in the future will not, have a material adverse effect on its financial condition, results of operations or business. VSCO has full corporate power and authority and all authorizations, licenses and permits necessary to carry on the business in which it is engaged or in which it proposes presently to engage and to own and use the properties owned and used by it. VSCO has delivered to Tianyin true, accurate and complete copies of its certificate or articles of incorporation and bylaws, which reflect all restatements of and amendments made thereto at any time prior to the date of this Agreement. The records of meetings of the Shareholders and Board of Directors of VSCO are complete and correct in all material respects. The stock records of VSCO and the Shareholder lists of VSCO that VSCO has previously furnished to Tianyin are complete and correct in all material respects and accurately reflect the record ownership and the beneficial ownership of all the outstanding shares of VSCO’s capital stock and any other outstanding securities issued by VSCO. VSCO is not in default under or in violation of any provision of its certificate or articles of incorporation or bylaws in any material respect. VSCO is not in any material default or in violation of any restriction, lien, encumbrance, indenture, contract, lease, sublease, loan agreement, note or other obligation or liability by which it is bound or to which any of its assets is subject.

  • Certain Filings Seller and Buyer shall cooperate with one another (i) in determining whether any action by or in respect of, or filing with, any Governmental Authority is required, or any actions, consents, approvals or waivers are required to be obtained from parties to any material contracts, in connection with the consummation of the transactions contemplated by this Agreement and (ii) in taking such actions or making any such filings, furnishing information required in connection therewith and seeking timely to obtain any such actions, consents, approvals or waivers.

  • Litigation and Environmental Matters (a) There are no actions, suits or proceedings by or before any arbitrator or Governmental Authority pending against or, to the knowledge of the Borrower, threatened against or affecting the Borrower or any of its Subsidiaries (i) as to which there is a reasonable possibility of an adverse determination and that, if adversely determined, could reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect (other than the Disclosed Matters) or (ii) that involve this Agreement or the Transactions.

  • Certain Litigation Matters The Owner Trustee shall provide prompt written notice to the Depositor, the Seller and the Servicer of any action, proceeding or investigation known to the Owner Trustee that could reasonably be expected to adversely affect the Trust or the Owner Trust Estate.

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