Compliance with Laws and Regulatory Matters Sample Clauses

Compliance with Laws and Regulatory Matters. (a) Seller (solely with respect to the Acquired Assets) is in compliance with all applicable Laws of any Governmental Entity currently in effect with respect to the Acquired Assets, including the FDCA and applicable implementing regulations and guidance issued by the FDA thereunder, except in each case where the failure to comply therewith would not reasonably be expected to be material to the ownership and use of the Acquired Assets. As of the date of this Agreement, Seller has not received written notice of any pending action, suit, proceeding, hearing, investigation, claim, demand or notice relating to the Acquired Assets alleging any failure to so comply, other than those that would not reasonably be expected to be material to the ownership and use of the Acquired Assets.
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Compliance with Laws and Regulatory Matters. (a) Seller is conducting the Business in compliance in all material respects with all Laws applicable to the Business or the Acquired Assets, including all Laws applicable to the nonclinical and clinical testing, manufacturing, ownership, operation, storage, import, export, distribution, marketing, pricing, sale, promotion, warehousing, packaging, Labeling, handling and/or testing of the Product (all such applicable Laws, collectively, the “Health Care Laws”). Since January 1, 2015, Seller has not received any written notice, including any warning letter, notice of adverse finding, or notice of deficiency, or similar communication from the FDA or any other Governmental Entity, (i) contesting the Transferred Regulatory Approvals, (ii) alleging that the Product or the ownership, manufacturing, operation, storage, import, export, distribution, marketing, pricing, sale, promotion, warehousing, packaging, Labeling, handling and/or testing thereof is in violation in any material respect of any applicable Health Care Law, Transferred Regulatory Approval or other Permit, or (iii) otherwise alleging any material violation of any Health Care Laws by Seller or any of its subsidiaries with respect to the Business and/or Product.
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Compliance with Laws and Regulatory Matters. (a) Each Acquired Company, each Business Subsidiary and (with respect to the Products or, otherwise, solely with respect to the Businesses) Parent is, and since January 1, 2013, has been, in material compliance with all applicable laws of any Governmental Entity currently in effect with respect to the Products or the Businesses, including the FDCA and applicable implementing regulations and final guidance issued by the FDA thereunder. As of the date of this Agreement, neither Parent nor any Acquired Company or Business Subsidiary has received any written notice or communication of any pending action, suit, proceeding, hearing, investigation, claim, demand or notice relating to the Products or the Businesses alleging any failure to so comply. Neither Parent nor any Acquired Company or Business Subsidiary has, since January 1, 2013 conducted an internal investigation resulting in a finding of an actual violation in any material respect of any law of any Governmental Entity by any officer or employee of Parent, any Acquired Company or any Business Subsidiary with respect to the Products or the Businesses.
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Compliance with Laws and Regulatory Matters. AVRA has complied, in all material respects, with all Laws and guidance (including, without limitation, current governmental regulations concerning good laboratory practices, good clinical practices and good manufacturing practices) applicable to the development activities for Company.
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Compliance with Laws and Regulatory Matters. (a) Except with respect to Legal Requirements related to Taxes or Intellectual Property, which will be governed solely by Sections 4.4 (Taxes) (with respect to Taxes) and 4.7 (Intellectual Property) (with respect to Intellectual Property), with respect to the Early Discovery Business, Purchased Assets, or Assumed Liabilities, Seller is in compliance with and, in the past two years has complied with, in all material respects, each Legal Requirement that is applicable to it in connection with any of its properties, assets, operations or business. As of the date hereof, with respect to the Early Discovery Business, Seller has not received any written notice from any third party that Seller is in violation of any Legal Requirement in any material respect.
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Compliance with Laws and Regulatory Matters 
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Related to Compliance with Laws and Regulatory Matters

  • Compliance with Laws and Policies Employee agrees that he will at all times comply with all applicable laws and all current and future lawful policies of the Company, not inconsistent with the intent of this agreement.

  • 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 Laws and Regulations (a) The exercise of this option and the issuance of the Option Shares upon such exercise shall be subject to compliance by the Corporation and Optionee with all applicable requirements of law relating thereto and with all applicable regulations of any stock exchange (or the Nasdaq National Market, if applicable) on which the Common Stock may be listed for trading at the time of such exercise and issuance.

  • Compliance with Laws; Licenses (i) The businesses of each of the Company and its Subsidiaries since the Applicable Date have not been, and are not being, conducted in violation of any applicable federal, state, local, foreign or transnational law, statute or ordinance, common law, or any rule or regulation (collectively, “Laws”) or any order, judgment, injunction, ruling, writ, award or decree of any Governmental Entity (collectively, “Order”), except for such violations that would not, individually or in the aggregate, reasonably be likely to have a Company Material Adverse Effect. No investigation or review by any Governmental Entity with respect to the Company or any of its Subsidiaries is pending or, to the Knowledge of the Company, threatened, nor has any Governmental Entity indicated an intention to conduct the same, except for such investigations or reviews the outcome of which would not, individually or in the aggregate, reasonably be likely to have a Company Material Adverse Effect. Except as would not, individually or in the aggregate, reasonably be likely to have a Company Material Adverse Effect, the Company and its Subsidiaries possess each permit, license, certification, approval, registration, consent, authorization, franchise, concession, variance, exemption and order issued or granted by a Governmental Entity (collectively, “Licenses”) necessary to conduct their respective businesses, since the Applicable Date have been in compliance with all terms and conditions of such Licenses, no such Licenses are subject to any actual or possible revocation, withdrawal, suspension, cancellation, termination or modification, and since the Applicable Date have not received written notice from any Governmental Entity alleging a conflict with or breach of any License. Notwithstanding the foregoing, this Section 5.1(j) shall not apply with respect to Taxes, which shall be covered exclusively by Section 5.1(n) or Environmental Laws, which shall be covered exclusively by Section 5.1(m).

  • Compliance With Laws and Approvals Observe and remain in compliance with all Applicable Laws and maintain in full force and effect all Governmental Approvals, in each case applicable to the conduct of its business except where the failure to do so could not reasonably be expected to have a Material Adverse Effect.

  • Compliance with Laws and Documents No Company shall (a) violate the provisions of any Laws or rulings of any Governmental Authority applicable to it or of any Material Agreement to which it is a party if that violation alone, or when aggregated with all other violations, would be a Material Adverse Event, (b) violate the provisions of its organizational documents if such violation would cause a Material Adverse Event, or (c) repeal, replace, or amend any provision of its organizational documents if that action would be a Material Adverse Event.

  • Litigation; Compliance with Laws (a) There are no actions, suits or proceedings at law or in equity by or before any Governmental Authority now pending or, to the knowledge of any Company, threatened against or affecting any Company or any business, Property or rights of any such Person (i) that involve any Loan Document or the Transactions or (ii) 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.

  • Litigation and Compliance with Laws (a) Except as disclosed in the Borrower’s Annual Report on Form 10-K for 2019 or any subsequent report filed by the Borrower on Form 10-Q or Form 8-K with the SEC since December 31, 2019, there are no actions, suits, proceedings or investigations pending or, to the knowledge of the Borrower or the Guarantors, threatened against the Borrower or the Guarantors or any of their respective properties (including any properties or assets that constitute Collateral under the terms of the Loan Documents), before any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, that (i) are likely to have a Material Adverse Effect or (ii) would reasonably be expected to affect the legality, validity, binding effect or enforceability of the Loan Documents or, in any material respect, the rights and remedies of the Administrative Agent or the Lenders thereunder or in connection with the Transactions.

  • Use and Compliance With Laws 8 6. TENANT IMPROVEMENTS & ALTERATIONS.................................. 11 7.

  • Compliance with Laws; Environmental Matters (i) Except with respect to Environmental Laws, the Employee Retirement Income Security Act of 1974, as amended (“ERISA”), taxes and regulatory compliance, which are the subjects of Sections 3.01(j)(ii), 3.01(l), 3.01(n) and 3.01(u), respectively, each of the Company and its Subsidiaries is in compliance with all Laws and Orders (collectively, “Legal Provisions”) applicable to it, its properties or other assets or its business or operations, except for failures to be in compliance that individually or in the aggregate have not had and would not reasonably be expected to have a Material Adverse Effect. Each of the Company and its Subsidiaries has in effect all approvals, authorizations, certificates, filings, franchises, licenses, notices and permits of or with all Governmental Entities (collectively, “Permits”), including all Permits under the Federal Food, Drug and Cosmetic Act of 1938, as amended (including the rules and regulations promulgated thereunder, the “FDCA”), necessary for it to own, lease or operate its properties and other assets and to carry on its business and operations as currently conducted, except where the failure to have such Permits individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. Since January 1, 2000, there has occurred no default under, or violation of, any such Permit, except for any such default or violation that individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. The consummation of the Merger, in and of itself, would not cause the revocation or cancelation of any such Permit that individually or in the aggregate would reasonably be expected to have a Material Adverse Effect.

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