Common use of Compliance with Laws, Regulations Clause in Contracts

Compliance with Laws, Regulations. (i) Each of the Company and its Subsidiaries is in compliance with all Laws applicable to its business or operations (including the Federal Food, Drug, and Cosmetics Act of 1938, as amended and applicable regulations promulgated thereunder by the United States Food and Drug Administration (the “FDA”), the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), Xxxxx Law (42 U.S.C. §1395nn), False Claims Act (31 X.X.X. §0000 et seq.) and the Foreign Corrupt Practices Act of 1977 (15 U.S.C. §§ 78dd-1 et seq.) except for instances of possible noncompliance that, individually or in the aggregate, would not have a Material Adverse Effect. Each of the Company and its Subsidiaries has in effect all approvals, authorizations, certificates, franchises, licenses, permits and consents of Governmental Entities (collectively, “Permits”) necessary for it to conduct its business as presently conducted, and all such Permits are in full force and effect, except for such Permits the absence of which, or the failure of which to be in full force and effect, individually or in the aggregate, would not have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries is currently excluded from participation, or is otherwise ineligible to participate, in a “federal health care program” as defined in 42 U.S.C. §1320a-7b(f) or since August 31, 2006 has been convicted of a criminal offense related to health care. Since August 31, 2006, there has occurred no default under, or violation of, any Permit, except for any such default or violation that individually or in the aggregate 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, modification or cancellation of any such Permit that individually or in the aggregate would reasonably be expected to have a Material Adverse Effect. This Section 3.01(j)(i) does not relate to matters relating to the Xxxxxxxx-Xxxxx Act, which are the subject of Section 3.01(e)(ii), environmental matters, which are the subject of Section 3.01(k), employee benefit matters, which are the subject of Section 3.01(m), and Taxes, which are the subject of Section 3.01(n).

Compliance with Laws, Regulations. (i) Each of the Company and its Subsidiaries is in compliance with all Laws applicable to its business or operations (including the Federal Food, Drug, and Cosmetics Act of 1938, as amended and applicable regulations promulgated thereunder by the United States Food and Drug Administration (the “FDA”), the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), Xxxxx Sxxxx Law (42 U.S.C. §1395nn), False Claims Act (31 X.X.X. U.X.X. §0000 et seq.) and the Foreign Corrupt Practices Act of 1977 (15 U.S.C. §§ 78dd-1 et seq.) except for instances of possible noncompliance that, individually or in the aggregate, would not have a Material Adverse Effect. Each of the Company and its Subsidiaries has in effect all approvals, authorizations, certificates, franchises, licenses, permits and consents of Governmental Entities (collectively, “Permits”) necessary for it to conduct its business as presently conducted, and all such Permits are in full force and effect, except for such Permits the absence of which, or the failure of which to be in full force and effect, individually or in the aggregate, would not have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries is currently excluded from participation, or is otherwise ineligible to participate, in a “federal health care program” as defined in 42 U.S.C. §1320a-7b(f) or since August 31, 2006 has been convicted of a criminal offense related to health care. Since August 31, 2006, there has occurred no default under, or violation of, any Permit, except for any such default or violation that individually or in the aggregate 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, modification or cancellation of any such Permit that individually or in the aggregate would reasonably be expected to have a Material Adverse Effect. This Section 3.01(j)(i) does not relate to matters relating to the XxxxxxxxSxxxxxxx-Xxxxx Act, which are the subject of Section 3.01(e)(ii), environmental matters, which are the subject of Section 3.01(k), employee benefit matters, which are the subject of Section 3.01(m), and Taxes, which are the subject of Section 3.01(n).

Compliance with Laws, Regulations. (i) Each of the Company and its Subsidiaries is is, and since December 31, 2008 has been, in compliance with all Laws applicable to its business or operations (including the Federal Food, Drug, and Cosmetics Act of 1938, as amended and applicable regulations promulgated thereunder by the United States Food and Drug Administration (the “FDA”), the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), Xxxxx Law (42 U.S.C. §1395nn), False Claims Act (31 X.X.X. §0000 et seq.) and the Foreign Corrupt Practices Act of 1977 (15 U.S.C. §§ 78dd-1 et seq.) except for instances of possible noncompliance that, individually or in the aggregate, have not had, and would not have reasonably be expected to have, a Company Material Adverse Effect. Each Except with respect to Regulatory Authorizations, which are the subject of Section 4.01(w), each of the Company and its Subsidiaries has in effect all approvals, authorizations, certificates, franchises, licenses, permits and consents of Governmental Entities (collectively, “Permits”) necessary for it material to the Company or any of its Subsidiaries in connection with the conduct of its business as presently conducted, and all such Permits are in full force and effect, except for such Permits the absence of which, or the failure of which to be in full force and effect, individually or in the aggregate, would not have a Company Material Adverse Effect. Neither The Company and each of its Subsidiaries is in compliance in all material respects with the terms of such Permits, no such Permit shall cease to be effective as a result of the transactions contemplated by this Agreement, including the Offer and the Merger, and neither the Company nor any of its Subsidiaries has received any written communication since January 1, 2009 from any Governmental Entity or employee, licensee, licensor, vendor or supplier of the Company or any of its Subsidiaries that alleges that the Company or any of its Subsidiaries is currently excluded from participationnot in compliance in all material respects with, or is otherwise ineligible subject to participate, in a “federal health care program” as defined in 42 U.S.C. §1320a-7b(f) or since August 31, 2006 has been convicted of a criminal offense related to health care. Since August 31, 2006, there has occurred no default any liability under, or violation of, any material Permit, except for any such default Law or violation that individually Judgment or in relating to the aggregate 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, revocation or modification or cancellation of any such Permit that individually or in the aggregate would reasonably be expected to have a Material Adverse Effectmaterial Permit. This Section 3.01(j)(i4.01(k) does not relate to matters relating to the Xxxxxxxx-Xxxxx Act, which are the subject of Section 3.01(e)(ii), environmental matters, which are the subject of Section 3.01(k4.01(l), employee benefit matters, which are the subject of Section 3.01(m4.01(m), and Taxes, which are the subject of Section 3.01(n4.01(n), and regulatory compliance matters, which are the subject of Section 4.01(w).