Other Regulatory Compliance. Borrower is not subject to regulation as an "investment company" or a company "controlled" by an "investment company" within the meaning of the Investment Company Act of 1940. Borrower is not engaged principally, or as one of the important activities, in the business of extending credit for the purpose of purchasing or carrying margin stock (within the meaning of Regulations T and U of the Board of Governors of the Federal Reserve System). Borrower has complied with all the provisions of the Federal Fair Labor Standards Act.
Other Regulatory Compliance. None of the transactions contemplated by the Transaction Documents will violate or result in a violation of Section 7 of the Exchange Act, or any regulation promulgated thereunder, including Regulations T, U and X of the Board of Governors of the Federal Reserve System.
Other Regulatory Compliance. (a) To the extent applicable to the Company Products, the Company Group is conducting and have conducted its business and operations in material compliance with the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), 21 U.S.C. §301 et. seq., and all applicable regulations promulgated by the FDA, including good clinical practices regulations and good laboratory practices regulations (collectively, “FDA Laws and Regulations”).
(b) The Company Group has not received any written notice or communication from the FDA alleging noncompliance with any applicable FDA Law and Regulation. The Company Group is not subject to any enforcement, regulatory, or administrative proceedings by the FDA and, to the Company’s Knowledge, no such proceedings have been threatened. There is no civil, criminal, or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, proceeding, or request for information pending against the Company Group, and, to the Company’s Knowledge, the Company Group has no liability (whether actual or contingent) for failure to comply with any FDA Laws and Regulations. To the Company’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or lead to any such action, suit, demand, claim, complaint, hearing, investigation, notice, demand letter, warning letter, proceeding, or request for information or any such liability pertaining to noncompliance with any FDA Laws and Regulations. There has not been any violation of any FDA Laws and Regulations by the Company Group in its product development efforts, submissions, record keeping, and reports to the FDA that could reasonably be expected to require or lead to investigation, corrective action, or enforcement, regulatory, or administrative action. To the Company’s Knowledge, there are no civil or criminal proceedings relating to the Company Group or any of the Company Group’s employees which involve a matter within or related to the FDA’s jurisdiction.
(c) No officer, employee, or agent of the Company Group has (i) made any untrue statement of material fact or fraudulent statement to the FDA or any other Governmental Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or (iii) committed an act, made a statement, or failed to make a statement that would reasonably be expected to provide the basis for the FDA to invoke its policy res...
Other Regulatory Compliance. (a) To the extent the Company’s Business as currently conducted, is directly subject to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301 et. seq.) or the United States Public Health Service Act (42 U.S.C. §201 et seq.) or the regulations promulgated thereunder, including without limitation good clinical practices, good laboratory practices and good manufacturing practices regulations and any similar foreign laws and regulations (collectively, “FDA Laws and Regulations”), the Company and its Affiliates have complied with FDA Laws and Regulations in all material respects. The Company and its Affiliates have made available complete and correct copies of all material reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other regulatory authority by the Company or its Affiliates which have been so filed, maintained or furnished. All such reports, documents, claims, permits and notices were complete and accurate on the date filed (or were corrected or supplemented by a subsequent filing). The Company and its Affiliates have not committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991), or similar policies set forth in any Laws or by any other Governmental Authority.
(b) The Company and its Affiliates have not received any written notice or written communication alleging noncompliance with any applicable FDA Laws and Regulations. The Company is not subject to any enforcement, regulatory, or administrative proceedings involving any FDA Laws and Regulations and, to the Company’s Knowledge, no such proceedings have been threatened. There is no civil, criminal, or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, Form FDA 483s, proceeding, or request for information pending against the Company and its Affiliates alleging violation of FDA Laws and Regulations.
(c) Except as provided in Section 3.14, there are no material permits, licenses, registrations, authorizations, clearances, approvals that are pending or have not been issued under FDA Laws and Regulations (“FD&C Permits”) that are required for the Company and its Affiliates to conduct its busin...
Other Regulatory Compliance. Neither Purchaser nor any Guarantor is an "investment company" or a company "controlled" by an "investment company" within the meaning of the Investment Company Act of 1940, as amended. Purchaser and Guarantor are not engaged principally, or as one of the important activities, in the business of extending credit for the purpose of purchasing or carrying margin stock (within the meaning of Regulations T and U of the Board of Governors of the Federal Reserve System). Purchaser and Guarantor have complied with all the provisions of the Federal Fair Labor Standards Act and the Labor Code of the Republic of Chile. Purchaser and Guarantor have not violated any statutes, laws, ordinances or rules applicable to them, violation of which would be reasonably likely to have a Material Adverse Effect.
Other Regulatory Compliance. (a) To the extent the Company’s Business as currently conducted, is directly subject to the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §301 et. seq., or the United States Public Health Service Act or the regulations promulgated thereunder, including without limitation good clinical practices, good laboratory practices and good manufacturing practices regulations and any similar foreign laws and regulations (collectively, “FDA Laws and Regulations”), the Company has complied with FDA Laws and Regulations in all material respects.
(b) The Company has not received any written notice or communication alleging noncompliance with any applicable FDA Laws and Regulations. The Company is not subject to any enforcement, regulatory, or administrative proceedings involving any FDA Laws and Regulations and, to the Company’s Knowledge, no such proceedings have been threatened. There is no civil, criminal, or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, proceeding, or request for information pending against the Company alleging violation of FDA Laws and Regulations.
(c) There are no material permits, licenses, registrations, clearances, approvals that are pending or have been issued under FDA Laws and Regulations (“FD&C Permits”) required for the Company to conduct its business operations in or outside the United States as presently conducted.
(d) The Company has neither sponsored nor conducted any nonclinical, preclinical or clinical studies, tests or trials subject to FDA Good Laboratory Practices or Good Clinical Practices.
Other Regulatory Compliance. No Loan Party has violated in any material respect any laws, ordinances or governmental rules. Except as otherwise set forth on Schedule 4.8, each Loan Party has timely filed all required material federal, state and local tax returns and paid, or made adequate provision to pay, all material taxes, assessments, deposits and contributions owed by such Loan Party. Each Loan Party has obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all government authorities that are necessary to continue its business as currently conducted.
Other Regulatory Compliance. Except as set forth in Section 4.15:
(a) The business of each of the Company and its Subsidiary are being conducted in compliance with all Laws, including (i) federal Medicare and Medicaid statutes and related state or local statutes and regulations; (ii) any comparable foreign Laws for any of the foregoing; (iii) federal or state criminal or civil Laws; and (iv) state licensing, disclosure and reporting requirements. Since December 31, 2006, the manufacture of products by the Company and its Subsidiary has been conducted in material compliance with all applicable Laws.
(b) Neither the Company nor its Subsidiary has Knowledge of any pending or threatened enforcement action by any Governmental Entity that has jurisdiction over the operations of the Company or its Subsidiary.
(c) All material reports, documents, claims, permits and notices required to be filed, maintained or furnished to any Governmental Entity by the Company and its Subsidiary have been so filed, maintained or furnished. All such reports, documents, claims and notices were complete and accurate in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing) such that no liability exists with respect to such filing.
(d) No Permit issued to the Company or its Subsidiary by any Governmental Entity has, since December 31, 2006, been limited, suspended, modified or revoked.
(e) The Company and its Subsidiary have not received any written notices, correspondence or other communication from any Governmental Entity since December 31, 2006 requiring termination, suspension or material modification of any manufacturing process by, or on behalf of, the Company or its Subsidiary, or in which the Company or its Subsidiary have participated.
(f) Since December 31, 2006, the Company and its Subsidiary have not either voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, warning or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of any product. The Company and its Subsidiary are not aware of any facts which are reasonably likely to cause (i) the recall, market withdrawal or replacement of any product sold or intended to be sold by the Company or its Subsidiary, (ii) a change in the marketing classification or a material change in the labeling of any such products, or (iii) a termination or suspension of th...
Other Regulatory Compliance. The Grantee will ensure that all permits, licenses, and certifications necessary to implement the project have been secured prior to construction, improvement, or acquisition of a capital asset. As may be necessary, the Grantee shall be responsible for obtaining the services of appropriately licensed professionals to comply with the applicable requirements of the Business and Professions Code including but not limited to section 6700 et seq. (Professional Engineers Act) or section 7800 et seq. (Geologists and Geophysicists Act). The Grantee is solely responsible for ensuring that the project meets all legal requirements. The Grantor will not issue construction, improvement, or acquisition funds until all permits are approved.
Other Regulatory Compliance. For matters not covered by Section 4.8(a), to the knowledge of Methodist, except as set forth in Schedule 4.8(b), the Facilities are in compliance in all material respects with all applicable statutes, rules, regulations and requirements of all Governmental Entities having jurisdiction over the Facilities and their operations, including, but not limited to, the Mississippi State Department of Health and JCAHO, and Methodist has timely filed all reports, data and other information required to be filed with such Governmental Entities where a failure to file timely would have a material adverse effect on the Facilities. Except as set forth in Schedule 4.8(b), neither Methodist nor the Hospitals have received written notice of a violation of any applicable ordinance or other law, order, regulation or requirement, or notice of condemnation, lien, assessment relating to any part of the Assets or the operation of the Facilities. To Methodist's knowledge, after reasonable inquiry, in order to consummate the transactions contemplated by this Agreement and the Lease Assignment, no certificate of need or other compliance with the Mississippi Health Care Certificate of Need Law of 1979, Mississippi Code Annotated Section 41-7-171 et seq, is required, with the sole exception of a thirty (30) day notice of change of ownership to the Mississippi State Department of Health.
