Permits; Regulatory Compliance Sample Clauses

Permits; Regulatory Compliance. The Company and its subsidiaries have all authorizations, approvals, clearances, licenses, permits, certificates or exemptions (including manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals, registration notifications or their foreign equivalent) issued by any regulatory authority or governmental agency (collectively, “Permits”) required to conduct their respective businesses as currently conducted except to the extent that the failure to have such Permits would not have a Material Adverse Effect. The conduct of business by the Company complies, and at all times has substantially complied, in all material respects, with the Food, Drug, and Cosmetic Act of 7 1938, as amended, and other federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each of the Company’s products, in whatever stage of development or commercialization, except to the extent that the failure to so comply would not have a Material Adverse Effect. To the knowledge of the Company, as of the date hereof, neither the U.S. Food and Drug Administration (the “FDA”) nor any comparable regulatory authority or governmental agency is considering limiting, suspending or revoking any such Permit or changing the marketing classification or labeling of the products of the Company or any of its subsidiaries. To the knowledge of the Company, there is no false or misleading information or material omission in any product application or other submission by the Company or any of its subsidiaries to the FDA or any comparable regulatory authority or governmental agency. The Company or its subsidiaries have fulfilled and performed in all material respects their obligations under each Permit, and, as of the date hereof, to the knowledge of the Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Permit except to the extent that such breach, default, revocation or termination would not have a Material Adverse Effect. To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company or any of its subsidiaries is in compliance in all material respects with all Permits insofar as they pertain to the manufacture of product components or products for the Company. The Company and its subsidiaries have not received any notice of adverse finding, warning ...
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Permits; Regulatory Compliance. (a) Each of Company, its Subsidiaries other than Flotation and to the Company’s knowledge Flotation, possesses all certificates, authorizations and permits issued by the appropriate federal, state, local or foreign regulatory authorities necessary to conduct their respective businesses as such businesses are described in the SEC Filings (as defined in Section 4.15) and the Private Placement Memorandum, except where the failure to possess such permits would not reasonably be expected to result in a Material Adverse Effect, and neither the Company, any Subsidiary other than Flotation, nor to the Company’s knowledge Flotation, has received any notice of proceedings relating to the revocation or modification of any material permit. (b) The Company and its Subsidiaries, the operation of their respective businesses and any real property that the Company or any of its Subsidiaries owns, leases or otherwise occupies or uses (the “Premises”) are to the Company’s knowledge with respect to the Company and each Subsidiary in material compliance with all applicable laws, rules and regulations of the jurisdictions in which it is conducting its business and orders or directives of any governmental authorities having jurisdiction. Neither the Company, any of its Subsidiaries other than Flotation nor to the Company’s knowledge Flotation, has been advised, or has reason to believe, that it is not conducting business in compliance with all applicable laws, rules and regulations of the jurisdictions in which it is conducting its business; in each case, except where failure to be in compliance would not have a Material Adverse Effect.
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Permits; Regulatory Compliance. (a) The Company is, and has at all times been, acting or operated in material compliance with any Law or Order applicable to the Company and its assets and properties. The Company, or any Person acting on its behalf, has not (i) received any written notice, notification or communication from any Governmental Authority or other Person regarding any actual or possible violation of, or failure to comply with any provision of, any Law or Order applicable to the Company or its assets or properties, or (ii) filed or otherwise provided any written notice, notification or communication to any Governmental Authority or other Person regarding any actual or possible violation of, or failure to comply with any provision of any Law or Order applicable to the Company or its assets or properties. For the avoidance of doubt, this Section 4.07 does not include any representations related to Intellectual Property. (b) Without limiting the generality of Section 4.07(a), the Company (including any of its officers, directors, agents, employees or other Persons associated with or acting on its behalf) has not, directly or indirectly, taken any action that would cause it to be in violation of the U.S. Foreign Corrupt Practices Act, the UK Anti-Bribery Act, each as amended, any other similar anti-bribery or anti-corruption Law, or any rule or regulation promulgated under any of the foregoing, including by offering or conveying, directly or indirectly (such as through an agent), anything of value to obtain or retain business or to obtain any improper advantage, including any bribe, rebate, payoff, influence payment, kickback or other similar unlawful payment to a foreign government official, candidate for office, or political party or official of a political party. (c) The Company is and has at all times been in possession of all Permits necessary for it to own, lease and operate its properties or to carry on its business as it is now being conducted, as it has been conducted, and as conducted as of the Effective Time, in each case, in all material respects. A true and complete list of all such Permits, including state distributor licenses, is set forth on Section 4.07(c) of the Company Disclosure Schedule, and each such Permit is valid and in full force and effect, and accurate and complete copies of such Permits have been delivered to Parent. The Company, or to the Company’s Knowledge, any Person acting on its behalf, is not and has not been in material conflict with, or in mate...
Sample 1
Permits; Regulatory Compliance. Supplier will be responsible for obtaining and maintaining at its expense, any licenses or permits, and any regulatory or governmental approvals necessary for Supplier’s manufacture of API at its manufacturing site. Customer will be responsible for maintaining full compliance with regulatory requirements as it relates to the API or its testing after Delivery. Each Party agrees to provide the other with reasonable assistance and take all reasonable actions requested by the other that are necessary or desirable to enable the other Party to comply with any law or regulation applicable to the API, or any ingredient of the API, or to the testing of the API.
Sample 1
Permits; Regulatory Compliance. (a) The Company as a whole owns, holds or possesses all material Permits that are necessary to entitle the Company to own or lease, operate and use their assets, and to carry on and conduct the business of the Company in all material respects as conducted immediately prior to the date hereof, and a list of all such Permits as of the date hereof is set forth on Schedule 3.19(a). The Company has complied in all material respects with the terms and conditions of such Permits. (b) The Company and, to the Knowledge of the Sellers, each of the Company’s officers and employees are not, and have not been, required to be registered, licensed or qualified as (i) an investment adviser, (ii) an investment adviser representative, or (iii) a broker-dealer, in the case of clauses (i), (ii) and (iii), with the SEC or any other Governmental Authority.
Sample 1
Permits; Regulatory Compliance. (a) Neither the Company nor, to the knowledge of the Company, any person acting on behalf of the Company, is in default or violation of any Law or any order, judgment, decision, determination, ruling, subpoena, verdict, writ, stipulation, award, injunction, decree, settlement agreement or similar agreement, arbitration award or finding entered by or with any Governmental Authority (including those of the Food and Drug Administration (the “FDA”) or any nongovernmental self-regulatory agency). The Company has timely filed or otherwise provided, or holds, all registrations, reports, data, documents, and other information and applications with respect to all products that are subject to federal, state or local regulatory requirements (the “Regulated Products”), if any, required to be filed with or otherwise provided to the FDA or any Governmental Authority with jurisdiction over the manufacture, distribution, labeling, advertising, promotion, use or sale of the Regulated Products, and all regulatory licenses or approvals in respect thereof are in full force and effect. The Regulated Products are not misbranded or adulterated or otherwise in violation of the Federal Food, Drug, and Cosmetic Act or other applicable federal, state or local Laws. (b) The Company is in possession of all franchises, grants, authorizations, licenses, permits, easements, variances, exceptions, consents, certificates, approvals and orders of any Governmental Authority (including the FDA or any nongovernmental self-regulatory agency) necessary for the Company to lease, use, occupy and operate its Leased Real Property and to carry on its business as it is now being conducted and as it is anticipated to be conducted after the Closing (the “Permits”). No suspension or cancellation of any Permits is pending or, to the knowledge of the Company, threatened. The Company is not in conflict with, or in default, breach or violation of (i) any Law applicable to the Company or by which any property or asset of the Company is bound or affected or (ii) any note, bond, mortgage, indenture, contract, agreement, lease, license, Permit, franchise or other instrument or obligation to which the Company is a party or by which the Company or any property or asset of the Company is bound, except, in each case, where such conflict, default, breach or violation would not, individually or in the aggregate, prevent or materially delay the Company from performing its obligations under this Agreement, or would not ...
Sample 1
Permits; Regulatory Compliance. (a) Purchaser will use commercially reasonable efforts to obtain all approvals, authorizations, consents, registrations, franchises, licenses, permits, U.S. Treasury listing as an insurer and reinsurer, or certificates by any Governmental Entity ("Permits") necessary to enable them to write the insurance policies or bonds and reinsurance contracts contemplated by this Agreement as soon as practicable after the date hereof. (b) Purchaser will comply in all material respects with all Applicable Laws relating to its conduct in performing its obligations and exercising its Renewal Rights under this Agreement.
Sample 1
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Related to Permits; Regulatory Compliance

  • 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.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Statutory and Regulatory Compliance Contractor shall comply with all laws and regulations applicable to the Community Development Block Grant-Disaster Recovery funds appropriated by the Disaster Relief Appropriations Act, 2013 (Pub. L. 113-2), including but not limited to the applicable Office of Management and Budget Circulars, which may impact the administration of funds and/or set forth certain cost principles, including the allowability of certain expenses.

  • Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities.

  • Financial Viability and Regulatory Compliance 2.6.1 Contractor warrants and represents that its corporate entity is in good standing with all applicable federal, state, and local licensing authorities and that it possesses all requisite licenses to perform the services required by this contract. Contractor further warrants and represents that it owes no outstanding delinquent federal, state or local taxes or business assessments. 2.6.2 Contractor agrees to promptly disclose to the MPHA any IRS liens or licensure suspension or revocation that may adversely affect its capacity to perform the services outlined within this contract. The failure by Contractor to disclose such issue to the MPHA in writing within 5 days of such notification received will constitute a material breach of this contract. 2.6.3 Contractor further agrees to promptly disclose to the MPHA any change of more than 50% of its ownership and/or any declaration of bankruptcy that Contractor may undergo during the term(s) of this contract. The failure of Contractor to disclose any change of more than 50% of its ownership and/or its declaration of bankruptcy within 5 days of said actions shall constitute a material breach of this contract. 2.6.4 All disclosures made pursuant to this section of the contract shall be made in writing and submitted to MPHA within the time periods required herein.

  • Legal and Regulatory Compliance ‌ 4.22.1 During the term of this Contract, Contractor must comply with all local, state, and federal licensing, accreditation and registration requirements/standards, necessary for the performance of this Contract and all other applicable federal, state and local laws, rules, and regulations. 4.22.2 While on the HCA premises, Contractor must comply with HCA operations and process standards and policies (e.g., ethics, Internet / email usage, data, network and building security, harassment, as applicable). HCA will make an electronic copy of all such policies available to Contractor. 4.22.3 Failure to comply with any provisions of this section may result in Contract termination.

  • Statutory Compliance ‌ The Union and the Employer agree to cooperate fully in matters pertaining to the prevention of accidents and occupational disease and in the promotion of the health and safety of all employees. There shall be full compliance with all applicable statutes and regulations pertaining to the working environment.

  • FERPA Compliance In connection with all FERPA Records that Contractor may create, receive or maintain on behalf of University pursuant to the Underlying Agreement, Contractor is designated as a University Official with a legitimate educational interest in and with respect to such FERPA Records, only to the extent to which Contractor (a) is required to create, receive or maintain FERPA Records to carry out the Underlying Agreement, and (b) understands and agrees to all of the following terms and conditions without reservation:

  • Safety Compliance Comply with Site safety programs, as they apply to RPR, and if required to do so by such safety programs, receive safety training specifically related to RPR’s own personal safety while at the Site.

  • FDA Compliance The Company: (A) is and at all times has been in material compliance with all statutes, rules or regulations of the FDA and other comparable governmental entities applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company (“Applicable Laws”); (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA or any governmental entity alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws (“Authorizations”); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and the Company is not in material violation of any term of any such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge that the FDA or any governmental entity or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (E) has not received notice that the FDA or any governmental entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and has no knowledge that the FDA or any governmental entity is considering such action; and (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission).

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