Regulatory Violations Clause Samples
Regulatory Violations. (a) SAFC represents and warrants that it does not and will not, and its Affiliates do not and will not, knowingly use in any capacity the services of any person or entity debarred under Section 306 of the Federal Food, Drug, and Cosmetic Act named on the FDA Debarment List (Drug Product Applications) (▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/ora/compliance_ref/debar/), or otherwise debarred under the corresponding Laws of another jurisdiction. Where permissible by local Laws, notably regulation on personal data protection, SAFC will as soon as practically possible disclose in writing to Company any information which comes to its attention and indicates that the statement in the preceding sentence is or may be incorrect. SAFC shall notify Company in writing as soon as practically possible if any Violation (as defined below) occurs or comes to its attention at any time during the Term. If a Violation exists with respect to any of SAFC’s officers, directors, Key Employees, or Subcontractors, SAFC shall promptly remove such individual(s) or entities from performing any service, function or capacity related to this Agreement. Company shall also have the right, in its sole discretion, to terminate this Agreement immediately in the event of any such Violation, if such Violation (i) is not cured by SAFC within [***] after receipt of a notification of such Violation from Company or (ii) cannot be cured by SAFC.
(b) SAFC represents and warrants that SAFC, its Affiliates and their respective officers and directors, and employees in the Manufacture of API, have not been, and will not be, in Violation. SAFC shall notify Company in writing as soon as practically possible if any such Violation occurs or comes to its attention. Company shall have the right, in its sole discretion, to terminate this Agreement and/or any purchase order immediately in the event of any such Violation. The term “Violation” shall mean that either SAFC or its Affiliates or, to SAFC’s knowledge any of their respective officers, directors, or employees Manufacturing API has been: (1) convicted of any of the felonies identified among the exclusion authorities listed on the U.S. Department of Health and Human Services, Office of Inspector General (OIG) website, including 42 U.S.C. 1320a-7(a) (▇▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/exclusions/authorities.asp ); (2) identified in the OIG List of Excluded Individuals/Entities (LEIE) database (▇▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/exclusions/authorities.asp ) or the U.S. General Services Administration's list o...
Regulatory Violations. AMAG represents and warrants that is has not been debarred under Article 306 of the FDCA, 21 U.S.C. §335a(a) or (b), or any equivalent foreign or local law, rule or regulation. In the event that AMAG becomes debarred, AMAG agrees to notify Ypsomed thereof immediately, and Ypsomed shall have the right to terminate this Agreement pursuant to Section 21.2. AMAG further represents and warrants that it has not and shall not knowingly use or employ in any capacity related to any activities under this Agreement any individual, corporation, partnership, or association which has been debarred under Article 306 of the FDCA, 21 U.S.C. §335a(a) or (b), or any equivalent foreign or local law, rule or regulation. In the event that Ypsomed becomes aware of or receives notice of the debarment of any such individual, corporation, partnership, or association providing services to it which relate to any activities under this Agreement, AMAG agrees to notify the Ypsomed immediately thereof, and Ypsomed shall have the right to terminate this Agreement pursuant to Section 21.2.
Regulatory Violations. Ypsomed represents and warrants that it and its employees, agents, officers and directors have not been debarred, disqualified or convicted of a crime for which one can be debarred under Article 306 of the FDCA, 21 U.S.C. §335a(a) or (b), or any equivalent foreign or local law, rule or regulation. In the event that Ypsomed or any of its employees, agents, officers and directors becomes so debarred, disqualified or convicted, Ypsomed agrees to notify AMAG thereof immediately, and AMAG shall have the right to terminate this Agreement pursuant to Section 21.2. Ypsomed further represents and warrants that it has not and shall not knowingly use or employ in any capacity related to any activities under this Agreement any individual, corporation, partnership, or association which has been debarred, disqualified or convicted of a crime for which one can be debarred under Article 306 of the FDCA, 21 U.S.C. §335a(a) or (b), or any equivalent foreign or local law, rule or regulation. In the event that Ypsomed becomes aware of or receives notice of the debarment, disqualification or conviction of any such individual, corporation, partnership, or association providing services to it which relate to any activities under this Agreement, Ypsomed agrees to notify AMAG immediately thereof, and AMAG shall have the right to terminate this Agreement pursuant to Section 21.2.
Regulatory Violations. (A) The Company is not currently being charged with nor is it operating its Business in violation of the federal Occupational Safety and Health Act of 1970, or the regulations promulgated thereunder, the Environmental Quality Improvement Act of 1970, or the regulations promulgated thereunder, or any other applicable law or regulation relating to the environment or occupational health and safety.
(B) Except as disclosed in Exhibit 5.12(B), (i) the Company has not received written notice of any violation by the Company of any Environmental Law, and no condition or event has occurred which, with notice or passage of time or both, would constitute a violation of any Environmental Law; (ii) no pollutants, contaminants or hazardous or toxic wastes, substances or materials, as defined by the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended, the Resource Conservation and Recovery Act of 1976, as amended, the Toxic Substances Control Act, or any other similar Federal, state or local statute, have been manufactured, generated, stored, handled, disposed, buried, dumped or used on, at or in connection with the Business; (iii) no asbestos, asbestos-containing materials, polychlorinated biphenyls (PCB's) PCB compounds, or other pollutants, contaminants, hazardous or toxic wastes, substances or materials have been placed on the real property of Seller, or to Seller's knowledge, by any other occupant of the real property, nor have they been used in the construction, repair, or alteration of any portion of the real property by the Seller, or to the Seller's knowledge, by any other occupant of the real property; and (iv) there are no above-ground or underground storage tanks, ▇▇▇▇▇, pools, settling ponds, traps, drains or other similar above-ground or subsurface structures present on or under the real property.
Regulatory Violations. The Company shall use its commercially reasonable efforts (which shall not include the hiring of any additional personnel or additional outside professionals and/or the payment of any additional material expense), prior to Closing, to (i) ensure material compliance with Regulation Z promulgated by the Board of Governors of the Federal Reserve, and (ii) ensure compliance with Article 24.14 of the Texas Insurance Code related to the payment of fees to Texas insurance agents or brokers.
Regulatory Violations. First Ozaukee shall have provided documentation to the satisfaction of Buyer's counsel evidencing resolution of any and all violations of all applicable Regulations, including the payment of all sums due and owing as a result of such violations and any penalties, fines and assessments related thereto.
Regulatory Violations. The Company is not currently being charged with nor, to the best knowledge of Seller, is it operating its Business in violation of the federal Occupational Safety and Health Act of 1970, or the regulations promulgated thereunder, the Environmental Quality Improvement Act of 1970, or the regulations promulgated thereunder, or any other applicable law or regulation relating to the import or export of goods or the environment or occupational health and safety, including laws or regulations relating to emission, discharges, releases or threatened releases of pollutants, contaminants, or hazardous materials. To the best knowledge of Seller, there are no physical conditions existing on any portion of the Assets or the site(s) at which the Business of the Company is being conducted that constitute a violation of any such law or regulation and no expenditures will be required in order for the Company to comply with any such existing law or regulation in connection with the operation of the Business after Buyer acquires the Assets from Seller, including, without limitation, expenditures relating to the clean-up or removal of any such pollutants, contaminants or hazardous materials which may have been discharged prior to the Closing Date at the site at which the Company is conducting the Business or any other discharge site. To the best knowledge of Seller, the Company is not operating the Business in violation of any applicable laws, regulations or ordinances, nor is the Company relying on any exemption from or deferral of any such applicable law or regulation that would not be available to it after Buyer acquires the Assets from Seller.