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). (ii) To the Knowledge of the Company (which, for purposes of this Section 3.01(j)(ii), shall include the actual Knowledge of the individuals listed on Section 3.01(j)(ii) of the Company Disclosure Letter), neither the Company nor any of its Subsidiaries is subject to any enforcement action by the FDA or any other Governmental Entity which has jurisdiction over the operations of the Company and its Subsidiaries except where such action would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. All material reports, documents, claims and notices required to be filed, maintained, or furnished to the FDA or any Governmental Entity by the Company and its Subsidiaries have been so filed, maintained or furnished. All such reports, documents, claims, and notices were complete and correct 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. (iii) Neither the Company nor any of its Subsidiaries has received any FDA Form 483s, notice of adverse findings, Warning Letters, untitled letters or other correspondence or notices from the FDA, or other Governmental Entity alleging or asserting noncompliance with any applicable Laws or Permit. (iv) All studies, tests, preclinical and clinical trials being conducted by the Company or any of its Subsidiaries are being conducted in material compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable Law. (v) Since August 31, 2004, the Company and its Subsidiaries have not, either voluntarily or involuntarily, initiated, conducted, or issued, or caused to be initiated, conducted or issued, any material recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice or other notice or action relating to an alleged lack of safety or efficacy of any product or product candidate, and, since August 31, 2004, to the Knowledge of the Company (which, for purposes of this Section 3.01(j)(v), shall include the actual Knowledge of the individuals listed on Section 3.01(j)(v) of the Company Disclosure Letter) there has been no manufacturing or design defect arising from the manufacturing of products by the Company or any of its Subsidiaries which would be reasonably likely to result in any of the foregoing and that, individually or in the aggregate, would be reasonably expected to have a Material Adverse Effect. The Company and its Subsidiaries are not aware of any facts which are reasonably likely to cause (1) the recall, market withdrawal or replacement of any product sold or intended to be sold by the Company or its Subsidiaries; (2) a change in the marketing classification or a material change in labeling of any such products; or (3) a termination or suspension of marketing of any such products.

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). (ii) To the Knowledge of the Company (which, for purposes of this Section 3.01(j)(ii), shall include the actual Knowledge of the individuals listed on Section 3.01(j)(ii) of the Company Disclosure Letter), neither the Company nor any of its Subsidiaries is subject to any enforcement action by the FDA or any other Governmental Entity which has jurisdiction over the operations of the Company and its Subsidiaries except where such action would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse Effect. All material reports, documents, claims and notices required to be filed, maintained, or furnished to the FDA or any Governmental Entity by the Company and its Subsidiaries have been so filed, maintained or furnished. All such reports, documents, claims, and notices were complete and correct 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. (iii) Neither the Company nor any of its Subsidiaries has received any FDA Form 483s, notice of adverse findings, Warning Letters, untitled letters or other correspondence or notices from the FDA, or other Governmental Entity alleging or asserting noncompliance with any applicable Laws or Permit. (iv) All studies, tests, preclinical and clinical trials being conducted by the Company or any of its Subsidiaries are being conducted in material compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable Law. (v) Since August 31, 2004, the Company and its Subsidiaries have not, either voluntarily or involuntarily, initiated, conducted, or issued, or caused to be initiated, conducted or issued, any material recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice or other notice or action relating to an alleged lack of safety or efficacy of any product or product candidate, and, since August 31, 2004, to the Knowledge of the Company (which, for purposes of this Section 3.01(j)(v), shall include the actual Knowledge of the individuals listed on Section 3.01(j)(v) of the Company Disclosure Letter) there has been no manufacturing or design defect arising from the manufacturing of products by the Company or any of its Subsidiaries which would be reasonably likely to result in any of the foregoing and that, individually or in the aggregate, would be reasonably expected to have a Material Adverse Effect. The Company and its Subsidiaries are not aware of any facts which are reasonably likely to cause (1) the recall, market withdrawal or replacement of any product sold or intended to be sold by the Company or its Subsidiaries; (2) a change in the marketing classification or a material change in labeling of any such products; or (3) a termination or suspension of marketing of any such products.

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). (ii) To the Knowledge of the Company (which, for purposes of this Section 3.01(j)(ii), shall include the actual Knowledge of the individuals listed on Section 3.01(j)(ii) of the Company Disclosure Letter)Company, neither the Company nor any of its Subsidiaries is subject to any material enforcement action by the FDA or any other Governmental Entity which has jurisdiction over the operations of the Company and its Subsidiaries except where such action would not, individually or in the aggregate, reasonably be expected to have a Company Material Adverse EffectSubsidiaries. All material reports, documents, claims and notices required to be filed, maintained, or furnished to the FDA or any Governmental Entity by the Company and its Subsidiaries have been so filed, maintained or furnished. All such reports, documents, claims, and notices were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filingfiling prior to the date hereof) such that no liability exists with respect to such filing. (iii) Neither . Since December 31, 2005, neither the Company nor any of its Subsidiaries has received engaged in any FDA Form 483s, notice of adverse findings, Warning Letters, untitled letters or other correspondence or notices from activity subject to the FDA, or other Governmental Entity alleging or asserting noncompliance with any applicable pharmaceutical regulatory Laws or Permit. (iv) All studies, tests, preclinical and clinical trials being conducted by the Company or any of its Subsidiaries are being conducted in material compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable Law. (v) Since August 31, 2004, the Company and its Subsidiaries have not, either voluntarily or involuntarily, initiated, conducted, or issued, or caused to be initiated, conducted or issued, any material recall, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice or other notice or action relating to an alleged lack of safety or efficacy of any product country other than the United States and China, including, but not limited to, laboratory testing, clinical research or product candidate, and, since August 31, 2004, to the Knowledge of the Company (which, for purposes of this Section 3.01(j)(v), shall include the actual Knowledge of the individuals listed on Section 3.01(j)(v) of the Company Disclosure Letter) there has been no manufacturing or design defect arising from the manufacturing of products by the Company or any of its Subsidiaries which would be reasonably likely to result in any of the foregoing and that, individually or in the aggregate, would be reasonably expected to have a Material Adverse Effect. The Company and its Subsidiaries are not aware of any facts which are reasonably likely to cause (1) the recall, market withdrawal or replacement of any product sold or intended to be sold by the Company or its Subsidiaries; (2) a change in the marketing classification or a material change in labeling of any such products; or (3) a termination or suspension of marketing of any such productsmanufacturing.