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...
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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.
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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.
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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.
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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.
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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.
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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.
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Related to Regulatory Violations

  • Regulatory Permits The Company and the Subsidiaries possess all certificates, authorizations and permits issued by the appropriate federal, state, local or foreign regulatory authorities necessary to conduct their respective businesses as described in the SEC Reports, except where the failure to possess such permits could not reasonably be expected to result in a Material Adverse Effect (“Material Permits”), and neither the Company nor any Subsidiary has received any notice of proceedings relating to the revocation or modification of any Material Permit.

  • Regulatory Approvals; No Defaults (i) No consents or approvals of, or filings or registrations with, any Governmental Authority or with any third party are required to be made or obtained by Sky or any of its Subsidiaries in connection with the execution, delivery or performance by Sky of this Agreement or to consummate the Parent Merger or the other transactions contemplated hereby except for (A) the filing of applications and notices, as applicable, with the Regulatory Authorities; (B) the filing and declaration of effectiveness of the Registration Statement; (C) the filing of the Certificates of Merger with the OSS pursuant to the OGCL; (D) such filings as are required to be made or approvals as are required to be obtained under the securities or “Blue Sky” Laws of various states in connection with the issuance of Sky Common Shares in the Parent Merger; and (E) receipt of the approvals set forth in Section 7.01(b). As of the date hereof, Sky is not aware of any reason why the Requisite Regulatory Approvals (as defined in Section 7.01(b)) will not be received without the imposition of a condition, restriction or requirement of the type described in Section 7.01(b). (ii) Subject to the satisfaction of the requirements referred to in the preceding paragraph and expiration of the related waiting periods, and required filings under federal and state securities Laws, the execution, delivery and performance of this Agreement and the consummation of the transactions contemplated hereby do not and will not (A) constitute a breach or violation of, or a default under, or give rise to any Lien, any acceleration of remedies or any right of termination under, any Law, governmental permit or license, or Contract of Sky or of any of its Subsidiaries or to which Sky or any of its Subsidiaries or properties is subject or bound, (B) constitute a breach or violation of, or a default under, the Governing Documents of Sky or any of its Subsidiaries, or (C) require any consent or approval under any such Law, governmental permit or license, or governmental Contract.

  • Regulatory Examinations The Sub-Advisor will cooperate promptly and fully with the Advisor and/or the Trust in responding to any regulatory or compliance examinations or inspections (including information requests) relating to the Trust, the Fund or the Advisor brought by any governmental or regulatory authorities having appropriate jurisdiction (including, but not limited to, the SEC).

  • Regulatory Compliance Neither Borrower nor any of its Subsidiaries is an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended. Neither Borrower nor any of its Subsidiaries is engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors). Borrower and each of its Subsidiaries has complied in all material respects with the Federal Fair Labor Standards Act. Neither Borrower nor any of its Subsidiaries is a “holding company” or an “affiliate” of a “holding company” or a “subsidiary company” of a “holding company” as each term is defined and used in the Public Utility Holding Company Act of 2005. Neither Borrower nor any of its Subsidiaries has violated any laws, ordinances or rules, the violation of which could reasonably be expected to have a Material Adverse Change. Neither Borrower’s nor any of its Subsidiaries’ properties or assets has been used by Borrower or such Subsidiary or, to Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than in material compliance with applicable laws. Borrower and each of its Subsidiaries has obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted. None of Borrower, any of its Subsidiaries, or any of Borrower’s or its Subsidiaries’ Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engaging in or conspiring to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person. None of Borrower, any of its Subsidiaries, or to the knowledge of Borrower and any of their Affiliates or agents, acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law.

  • Regulatory Activities a) As between the Parties, Xynomic shall have the sole responsibility and discretion for preparing, obtaining, and maintaining Drug Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals and other submissions, and for conducting communications with the Regulatory Authorities, for Licensed Compounds or Licensed Products in the Territory (which shall include filings of or with respect to INDs and other filings or communications with the Regulatory Authorities). All Regulatory Approvals relating to the Licensed Compounds or Licensed Products with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, Xynomic or its designated Affiliate. Pharmacyclics hereby assigns to Xynomic all of Pharmacyclics’ (or its Affiliates’) right, title, and interest in and to all Regulatory Documentation owned by Pharmacyclics (or its Affiliates) and held in Pharmacyclics’ name (or its Affiliates) as of the Effective Date or generated in the “winding up” activities after the Effective Date and shall deliver all Regulatory Documentation as well as embodiments of all Regulatory Documentation to Xynomic within sixty (60) days after the Effective Date. b) Xynomic shall notify the Pharmacyclics Alliance Manager promptly (but in no event later than forty-eight (48) hours) following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Licensed Compound or Licensed Product in the Territory, and shall include in such notice the reasoning behind such determination, and any supporting facts. Xynomic (or its Sublicensee) shall have the right to make the final determination whether to voluntarily implement any such recall, market suspension, or market withdrawal in the Territory; provided that prior to any implementation of such a recall, market suspension, or market withdrawal, Xynomic shall consult with Pharmacyclics and shall consider Pharmacyclics’ comments in good faith. If a recall, market suspension, or market withdrawal is mandated by a Regulatory Authority in the Territory, Xynomic (or its Sublicensee) shall initiate such a recall, market suspension, or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions, or market withdrawals undertaken pursuant to this Section 2.2.1.b), Xynomic (or its Sublicensee) shall be solely responsible for the execution and all costs thereof.