Compliance With Laws Regulatory Affairs Recalls Sample Clauses

Compliance With Laws Regulatory Affairs Recalls 
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  • Compliance with Regulatory Requirements Upon demand by Lender, Borrower shall reimburse Lender for Lender’s additional costs and/or reductions in the amount of principal or interest received or receivable by Lender if at any time after the date of this Agreement any law, treaty or regulation or any change in any law, treaty or regulation or the interpretation thereof by any Governmental Authority charged with the administration thereof or any other authority having jurisdiction over Lender or the Loans, whether or not having the force of law, shall impose, modify or deem applicable any reserve and/or special deposit requirement against or in respect of assets held by or deposits in or for the account of the Loans by Lender or impose on Lender any other condition with respect to this Agreement or the Loans, the result of which is to either increase the cost to Lender of making or maintaining the Loans or to reduce the amount of principal or interest received or receivable by Lender with respect to such Loans. Said additional costs and/or reductions will be those which directly result from the imposition of such requirement or condition on the making or maintaining of such Loans.

  • Reports; Regulatory Matters (a) Each of the Companies and their Subsidiaries have timely filed or furnished, as applicable, all reports, registrations, statements and certifications, together with any amendments required to be made with respect thereto, that they were required to file or furnish, as applicable, since January 1, 2006 with (i) any state regulatory authority, (ii) the SEC, (iii) any foreign regulatory authority, and (iv) any self-regulatory authority, (collectively, “Regulatory Agencies”) and with each other applicable Governmental Entity, and all other reports and statements required to be filed or furnished by them since January 1, 2006, including any report or statement required to be filed pursuant to the laws, rules or regulations of the United States, any state, any foreign entity, or any Regulatory Agency or other Governmental Entity, and have paid all fees and assessments due and payable in connection therewith. Except as set forth in Section 3.5 of the Company Disclosure Schedule, no Regulatory Agency or other Governmental Entity has initiated since January 1, 2006 or has pending any proceeding, enforcement action or, to the knowledge of Seller, investigation into the business, disclosures or operations of any of the Companies or any of its Subsidiaries. Since January 1, 2006, no Regulatory Agency or other Governmental Entity has resolved any proceeding, enforcement action or, to the knowledge of Seller, investigation into the business, disclosures or operations of any of the Companies or any of its Subsidiaries. There is no unresolved, or, to Seller’s knowledge, threatened criticism, comment, exception or stop order by any Regulatory Agency or other Governmental Entity with respect to any report or statement relating to any examinations or inspections of any of the Companies or any of its Subsidiaries. Since January 1, 2006, there have been no formal or informal inquiries by, or disagreements or disputes with, any Regulatory Agency or other Governmental Entity with respect to the business, operations, policies or procedures of any of the Companies or any of its Subsidiaries (other than normal inquiries made by a Regulatory Agency or other Governmental Entity in the Companies’ ordinary course of business). (b) No Company nor any of its Subsidiaries is subject to any cease-and-desist or other order or enforcement action issued by, or is a party to any written agreement, consent agreement or memorandum of understanding with, or is a party to any commitment letter or similar undertaking to, or is subject to any order or directive by, or has been ordered to pay any civil money penalty by, or has been since January 1, 2006 a recipient of any supervisory letter from, or since January 1, 2006 has adopted any policies, procedures or board resolutions at the request or suggestion of, any Regulatory Agency or other Governmental Entity that currently restricts or affects in any material respect the conduct of its business (or to Seller’s knowledge that, upon consummation of the transactions contemplated hereby, would restrict in any material respect the conduct of the business of either Buyer or any of its Subsidiaries), or that in any material manner relates to its capital adequacy, its ability to pay dividends, its credit, risk management or compliance policies, its internal controls, its management or its business, other than those of general application that apply to similarly situated companies or their Subsidiaries (each item in this sentence, a “Company Regulatory Agreement”), nor has any of the Companies or any of their Subsidiaries been advised since January 1, 2006 by any Regulatory Agency or other Governmental Entity that it is considering issuing, initiating, ordering, or requesting any such Company Regulatory Agreement. (c) Seller has previously made available to Buyers an accurate and complete copy of each (i) final registration statement, prospectus, report, schedule and definitive proxy statement filed with the SEC by Seller pursuant to the Securities Act or the Securities Exchange Act of 1934, as amended (the “Exchange Act”) since January 1, 2006 (the “Seller SEC Reports”) and prior to the date of this Agreement and (ii) communication mailed by Seller to its shareholders since January 1, 2006 and prior to the date of this Agreement. No such Seller SEC Report or communication, at the time filed or communicated (or, if amended prior to the date hereof, as of the date of such amendment), with respect to the Companies and their Subsidiaries only, contained any untrue statement of a material fact or omitted to state any material fact required to be stated therein or necessary in order to make the statements made therein, in light of the circumstances in which they were made, not misleading. To the knowledge of Seller, other than as set forth in Section 3.5 of the Company Disclosure Schedule, none of the Seller SEC Reports is the subject of any ongoing review or investigation by the SEC or any other Governmental Entity and there are no unresolved SEC comments with respect to any of such documents.

  • Compliance with Laws, Regulations, Etc (a) Each Borrower and Guarantor shall, and shall cause any Subsidiary to, at all times, comply in all material respects with all laws, rules, regulations, licenses, approvals, orders and other Permits applicable to it and duly observe in all material respects all requirements of any foreign, Federal, State or local Governmental Authority. (b) Borrowers and Guarantors shall give written notice to Agent promptly upon any Borrower’s or Guarantor’s receipt of any written notice of, or any Borrower’s or Guarantor’s otherwise obtaining knowledge of, (i) the occurrence of any event involving the material release, spill or discharge, threatened or actual, of any Hazardous Material in violation of Environmental Laws or (ii) any investigation, proceeding, complaint, order, directive, claims, citation or notice with respect to: (A) any non-compliance with or violation of any Environmental Law by any Borrower or Guarantor or (B) the release, spill or discharge, threatened or actual, of any Hazardous Material other than in the ordinary course of business and other than as permitted under any applicable Environmental Law. Copies of all environmental surveys, audits, assessments, feasibility studies and results of remedial investigations relating to any Real Property shall be furnished, or caused to be furnished, by such Borrower or Guarantor to Agent promptly upon such Borrower’s or Guarantor’s receipt thereof. Each Borrower and Guarantor shall take prompt action to respond to any material non-compliance with any of the Environmental Laws and shall regularly report to Agent on such response. (c) Without limiting the generality of the foregoing, whenever Agent reasonably determines that there is material non-compliance, or any condition which requires any action by or on behalf of any Borrower or Guarantor in order to avoid any material non-compliance, with any Environmental Law, Borrowers shall, at Agent’s request and Borrowers’ expense: (i) cause an independent environmental engineer reasonably acceptable to Agent to conduct such tests of the site where material non-compliance or alleged material non-compliance with such Environmental Laws has occurred as to such material non-compliance and prepare and deliver to Agent a report as to such material non-compliance setting forth the results of such tests, a proposed plan for responding to any environmental problems described therein, and an estimate of the costs thereof and (ii) provide to Agent a supplemental report of such engineer whenever the scope of such material non-compliance, or such Borrower’s or Guarantor’s response thereto or the estimated costs thereof, shall change in any material respect. (d) Each Borrower and Guarantor shall indemnify and hold harmless Agent and Lenders and their respective directors, officers, employees, agents, invitees, representa­tives, successors and assigns, from and against any and all losses, claims, damages, liabilities, costs, and expenses (including reasonable attorneys’ fees and expenses) directly or indirectly arising out of or attributable to the use, generation, manufacture, reproduction, storage, release, threatened release, spill, discharge, disposal or presence of a Hazardous Material, including the costs of any required or necessary repair, cleanup or other remedial work with respect to any property of any Borrower or Guarantor and the preparation and implementation of any closure, remedial or other required plans; provided, that, Borrowers and Guarantors shall not be required to indemnify for any such losses, claims, damages, liabilities, costs or expenses directly resulting from acts of Agent or any Lender with respect to a parcel of Real Property while Agent or such Lender is the owner or operator of such parcel of Real Property. All representations, warranties, covenants and indemnifications in this Section 9.3 shall survive the payment of the Obligations and the termination of this Agreement.

  • Compliance with Laws and Policies In carrying out the terms of this Agreement, both Parties shall comply with all applicable federal, state and local laws, regulations and rules, DSRIP Requirements, and the CNYCC Compliance Program.

  • Compliance with Laws, Etc Comply, and cause each of its Subsidiaries to comply with all applicable laws, rules, regulations and orders, such compliance to include, without limitation, compliance with ERISA and Environmental Laws, except where the failure to do so, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect.

  • Certain Regulatory Matters Except as set forth on Section 2.24 of the Disclosure Schedules: (a) No member of the Seller Group is in receipt of notice of, or is subject to any investigation, adverse inspection observation, finding of deficiency, fine, reprimand, sanction, assessment, finding of non-compliance, regulatory, untitled or warning letter, FDA form 483, safety alert, mandatory or voluntary recall, other reportable corrective or remedial action, or other compliance or enforcement action (“Regulatory Actions”), in each case relating to the Business Products or to the facilities in which the Business Products are prepared, assembled, tested, packaged, labeled, stored or handled, issued by any applicable Governmental Authority, and/or commercialization activities conducted by or on behalf of any member of the Seller Group, or alleging that any member of the Seller Group was or is the subject of any pending, threatened or anticipated Action or Regulatory Action by any Governmental Authority, or that there are circumstances currently existing which might reasonably be expected to lead to any loss of or refusal to renew any of the Regulatory Licenses held by any member of the Seller Group. To Sellers’ Knowledge, there is no act, omission, event, or circumstance that could reasonably be expected to give rise to any such Regulatory Action against any member of the Seller Group. No member of the Seller Group has received any written notification from the FDA or any other applicable Governmental Authority indicating that any of the Business Products or components thereof is misbranded or adulterated. (b) No member of the Seller Group has made any false statements on, or material omissions from, any applications, certifications, reports or other submissions to any applicable Governmental Authority or in or from any other records and documentation prepared or maintained to comply with the requirements of any Governmental Authority relating to the Business Products. There has not been any violation of any laws by any member of the Seller Group in prior product development efforts, submissions or reports to any Governmental Authority that could reasonably be expected to require investigation, corrective action or enforcement action by any member of the Seller Group with respect to the Business Products. (c) No member of the Seller Group: (i) has made an untrue statement of material fact or fraudulent statement to the FDA, United States Department of Agriculture (“USDA”) or any other Governmental Authority with respect to any product produced sold by any member of the Seller Group, or (ii) has failed to disclose a material fact required to be disclosed to the FDA, USDA or any other Governmental Authority. (d) No member of the Seller Group: (i) has made or offered any payment, gratuity or other thing of value that is prohibited by any Law to personnel of the FDA, USDA or any other Governmental Authority or any other Person; (ii) has been convicted of any crime under any applicable Laws; (iii) while acting in such capacity, is considered a restricted individual under the Perishable Agricultural Commodities Act (“PACA”), has been required to post a surety bond in connection with a bankruptcy proceeding, or is under PACA employment restrictions; (iv) is involved in a business dispute, including informal or formal complaint, mediation, or is aware of any threatened complaints or disputes by any applicable Governmental Authority or other third parties under PACA; (v) used any funds to make, any unlawful contribution, gift, bribe, payoff, kickback or other unlawful payment to any Government Official or has violated any provision of the U.S. Foreign Corrupt Practices Act (the “FCPA”); (vi) discovered any potential or actual violation of the FCPA or any other applicable anti-corruption Law; (vii) received any written communication from any Governmental Authority alleging that any member of the Seller Group, or any director, officer, agent or employee acting on behalf of any member of the Seller Group was in violation of the FCPA or any other applicable anti-corruption Law; (viii) not been in compliance with the FCPA or any other applicable anti-corruption Law. (e) During the 24 months immediately preceding the date of this Agreement, no Business Product has been recalled, whether voluntary or otherwise and no member of the Seller Group has received notice, either completed or pending, of any proceeding seeking a recall, removal, or corrective action of any Business Product. No member of the Seller Group has filed a report under the FDA’s Reportable Food Registry or been restrained in its ability to produce, market, test, or other corrective action, sell, distribute, or promote any Business Product. To the Sellers’ Knowledge, there are no facts, including product quality complaints that would be reasonably likely to result in a voluntary or mandatory product recall or expansion of recall. (f) No member of the Seller Group is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Authority.

  • Compliance with Laws and Orders Buyer is not in violation of or in default under any Law or order applicable to Buyer or its Assets the effect of which, in the aggregate, would reasonably be expected to hinder, prevent or delay Buyer from performing its obligations hereunder.

  • Compliance with Federal and State Work Authorization and Immigration Laws The Contractor and all subcontractors, suppliers and consultants must comply with all federal and state work authorization and immigration laws, and must certify compliance using the form set forth in Section 7 (“Georgia Security and Immigration Compliance Act Affidavits”). The required certificates must be filed with the Owner and copied maintained by the Contractor as of the beginning date of this contract and each subcontract, supplier contract, or consultant contract, and upon final payment to the subcontractor or consultant. State officials, including officials of the Georgia Department of Audits and Accounts, officials of the Owner, retain the right to inspect and audit the Project Site and employment records of the Contractor, subcontractors and consultants without notice during normal working hours until Final Completion, and as otherwise specified by law and by Rules and Regulations of the Georgia Department of Audits and Accounts.

  • COMPLIANCE WITH LAWS, STATUTES, REGULATIONS a) During the term of this Master Contract the CONTRACTOR and the LEA shall comply with all applicable federal and state laws and regulations relating to the provision of special education and related services, and facilities for individuals with exceptional needs. b) CONTRACTOR shall also comply with all applicable policies pursuant to the Local Plan, unless, taking into consideration all of the surrounding facts and circumstances, a policy or policies or a portion of a policy does not reasonably apply to CONTRACTOR. c) CONTRACTOR hereby acknowledges and agrees that it accepts all risks and responsibilities for its failure to comply with applicable LEA policies and shall indemnify LEA under the provisions of section 16 of this Master Contract for all liability, loss, damage and expense (including reasonable attorneys’ fees) resulting from or arising out of CONTRACTOR’s failure to comply with LEA policies. d) The CONTRACTOR shall comply with those policies, relating to among other things, the provision of special education and/or related services, facilities for individuals with exceptional needs, LEA pupil enrollment and transfer, LEA student inactive status, corporal punishment, student discipline, and positive behavior interventions.

  • Compliance with Labor Laws Except as would not, individually or in the aggregate, result in a Material Adverse Change, (i) there is (A) no unfair labor practice complaint pending or, to the best of the Company’s knowledge, threatened against the Company or any of its subsidiaries before the National Labor Relations Board, and no grievance or arbitration proceeding arising out of or under collective bargaining agreements pending, or to the best of the Company’s knowledge, threatened, against the Company or any of its subsidiaries, (B) no strike, labor dispute, slowdown or stoppage pending or, to the best of the Company’s knowledge, threatened against the Company or any of its subsidiaries and (C) no union representation question existing with respect to the employees of the Company or any of its subsidiaries and, to the best of the Company’s knowledge, no union organizing activities taking place and (ii) there has been no violation of any federal, state or local law relating to discrimination in hiring, promotion or pay of employees or of any applicable wage or hour laws.

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