Common use of Material Compliance With Laws Clause in Contracts

Material Compliance With Laws. The business of Parent and its Subsidiaries is being conducted in material compliance with the pertinent Laws of Governmental Entities, including without limitation, the laws enforced and regulations issued by the FDA, the DEA, the HHS, the CMS and OIG, including without limitation the anti-kickback law (Social Security Act § 1128B(b)) and analogous laws of the various states, the drug price reporting requirements of titles XVIII and XIX of the Social Security Act, and the laws precluding off-label marketing of drugs, except for violations and alleged violations that are described in the Parent Reports or would not be reasonably expected to have, either individually or in the aggregate, a Parent Material Adverse Effect or prevent or materially impair the ability of Parent to consummate the transactions contemplated by this Agreement. Neither Parent nor any of its Subsidiaries is debarred under the Generic Drug Enforcement Act of 1992 or employs or uses the services of any individual who is debarred or, to the best of Parent’s knowledge, has engaged in any activity that would reasonably be expected to lead to debarment. Except as described in the Parent Reports or for ongoing inspections of Parent’s and its Subsidiaries’ manufacturing facilities and product applications, which would not be reasonably expected, individually or in the aggregate, to have a Material Adverse Effect, no investigation or review, other than routine inspections by the FDA, by any Governmental Entity with respect to Parent or any of its Subsidiaries is pending or, to the knowledge of Parent, threatened, nor has any Governmental Entity indicated an intention to conduct the same, except for those the outcome of which would not be reasonably expected to have, either individually or in the aggregate, a Parent Material Adverse Effect or prevent or materially impair the ability of Parent to consummate the transactions contemplated by this Agreement. Parent and each of its Subsidiaries has all permits, licenses, franchises, variances, exemptions, orders and other governmental authorizations, consents and approvals from Governmental Entities necessary to conduct its business as currently conducted, except for those the absence of which would not be reasonably expected to have, either individually or in the aggregate, a Parent Material Adverse Effect or prevent or materially impair the ability of Parent to consummate the transactions contemplated by this Agreement. Neither Parent, any of its Subsidiaries nor, to the knowledge of Parent, any of the vendors or suppliers of Parent or any of its Subsidiaries have been excluded from participation in any federal health care program, as defined under 42 U.S.C. §1320a-7b(f), for the provision of items or services for which payment may be made under such federal health care program, nor been debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded by any state or federal department or agency. To the extent matters relating to Parent’s and its Subsidiaries’ compliance with any Laws, including with respect to Environmental Laws, are more specifically covered elsewhere in this Section 5.2, the provisions of this Section 5.2(k) shall not apply.

Material Compliance With Laws. The business of Parent the Company and its Subsidiaries is being conducted in material compliance with the pertinent Laws of Governmental Entities, including without limitation, limitation the laws enforced and regulations issued by the FDAUnited States Drug Enforcement Administration (“DEA”), the DEADepartment of Health and Human Services (“HHS”) and its constituent agencies, the HHSUnited States Food and Drug Administration (the “FDA”), the CMS Centers for Medicare & Medicaid Services (“CMS”), and Office of Inspector General (“OIG”), including without limitation the anti-kickback law (Social Security Act § 1128B(b)) and analogous laws of the various states, the drug price reporting requirements of titles XVIII and XIX of the Social Security Act, and the laws precluding off-label marketing of drugs, except for violations and alleged violations that are described in the Parent Company Reports or that would not be reasonably expected to have, either individually or in the aggregate, a Parent Company Material Adverse Effect or prevent or materially impair the ability of Parent the Company to consummate the transactions contemplated by this Agreement. Neither Parent the Company nor any of its Subsidiaries is debarred under the Generic Drug Enforcement Act of 1992 or employs or uses the services of any individual who is debarred or, to the best of ParentCompany’s knowledge, has engaged in any activity that would reasonably be expected to lead to debarment. Except as described in the Parent Company Reports or as set forth on Section 5.1(k) of the Company Disclosure Schedules, and except for ongoing inspections of Parentthe Company’s and its Subsidiaries’ manufacturing facilities and product applications, which would not be reasonably expected, individually or in the aggregate, to have a Material Adverse Effect, no investigation or review, other than routine inspections by the FDA, by any Governmental Entity with respect to Parent the Company or any of its Subsidiaries is pending or, to the knowledge of Parentthe Company, threatened, nor has any Governmental Entity indicated an intention to conduct the same, except for those the outcome of which would not be reasonably expected to have, either individually or in the aggregate, a Parent Company Material Adverse Effect or prevent or materially impair the ability of Parent the Company to consummate the transactions contemplated by this Agreement. Parent The Company and each of its Subsidiaries has, or has applied for, all permits, licenses, franchises, variances, exemptions, orders and other governmental authorizations, consents and approvals from Governmental Entities necessary to conduct its business as currently conducted, except for those the absence of which would not be reasonably expected to have, either individually or in the aggregate, a Parent Company Material Adverse Effect or prevent or materially impair the ability of Parent the Company to consummate the transactions contemplated by this Agreement. Neither Parentthe Company, any of its Subsidiaries nor, to the knowledge of Parentthe Company, any of the vendors or suppliers of Parent the Company or any of its Subsidiaries have been excluded from participation in any federal health care program, as defined under 42 U.S.C. §1320a-7b(f), for the provision of items or services for which payment may be made under such federal health care program, nor been debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded by any state or federal department or agency. To the extent matters relating to Parentthe Company’s and its Subsidiaries’ compliance with any United States or foreign, federal, state or local law, statute, ordinance, rule, regulation, judgment, order, injunction, decree, arbitration award, agency requirement, license or permit of any Governmental Entity, each as in effect as of the date hereof regardless of any retroactive effect of any subsequent amendment thereof (collectively, “Laws”), including with respect to Environmental Laws, are more specifically covered elsewhere in this Section 5.25.1, the provisions of this Section 5.2(k5.1(k) shall not apply.

Material Compliance With Laws. The business of Parent the Borrower and its Subsidiaries is being conducted in material compliance with the pertinent Laws of Governmental Entities, including without limitation, limitation the laws enforced and regulations issued by the DEA, the Department of Health and Human Services and its constituent agencies, the FDA, the DEACenters for Medicare & Medicaid Services, the HHS, the CMS and OIGOffice of Inspector General, including without limitation the anti-kickback law (Social Security Act § §1128B(b)) and analogous laws of the various states, the drug price reporting requirements of titles XVIII and XIX of the Social Security Act, and the laws precluding off-label marketing of drugs, except for violations and alleged violations that are described in the Parent Company Reports or that would not be reasonably expected to have, either individually or in the aggregate, a Parent Material Adverse Effect or prevent or materially impair the ability of Parent any Loan Party to consummate the transactions contemplated by this the Loan Documents or the Merger Agreement. Neither Parent the Borrower nor any of its Subsidiaries is debarred under the Generic Drug Enforcement Act of 1992 or employs or uses the services of any individual who is debarred or, to the best of ParentBorrower’s knowledge, has engaged in any activity that would reasonably be expected to lead to debarment. Except as described in the Parent Company Reports or as set forth on Section 5.1(k) of the Company Disclosure Schedules, and except for ongoing inspections of Parentthe Borrower’s and its Subsidiaries’ manufacturing facilities and product applications, which would not be reasonably expected, individually or in the aggregate, to have a Material Adverse Effect, no investigation or review, other than routine inspections by the FDA, by any Governmental Entity with respect to Parent the Borrower or any of its Subsidiaries is pending or, to the knowledge of Parentthe Borrower, threatened, nor has any Governmental Entity indicated an intention to conduct the same, except for those the outcome of which would not be reasonably expected to have, either individually or in the aggregate, a Parent Material Adverse Effect or prevent or materially impair the ability of Parent any Loan Party to consummate the transactions contemplated by this the Loan Documents or the Merger Agreement. Parent The Borrower and each of its Subsidiaries has, or has applied for, all permits, licenses, franchises, variances, exemptions, orders and other governmental authorizations, consents and approvals from Governmental Entities necessary to conduct its business as currently conducted, except for those the absence of which would not be reasonably expected to have, either individually or in the aggregate, a Parent Material Adverse Effect or prevent or materially impair the ability of Parent any Loan Party to consummate the transactions contemplated by this the Loan Documents or the Merger Agreement. Neither Parentthe Borrower, any of its Subsidiaries nor, to the knowledge of Parentthe Borrower, any of the vendors or suppliers of Parent the Borrower or any of its Subsidiaries have been excluded from participation in any federal health care program, as defined under 42 U.S.C. §1320a-7b(f), for the provision of items or services for which payment may be made under such federal health care program, nor been debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded by any state or federal department or agency. To the extent matters relating to Parentthe Borrower’s and its Subsidiaries’ compliance with any United States or foreign, federal, state or local law, statute, ordinance, rule, regulation, judgment, order, injunction, decree, arbitration award, agency requirement, license or 44 permit of any Governmental Entity, each as in effect as of the date hereof regardless of any retroactive effect of any subsequent amendment thereof (collectively, “Laws”), including with respect to Environmental Laws, are more specifically covered elsewhere in this Section 5.2Article V, the provisions of this Section 5.2(k) 5.09 shall not apply.