Common use of Compliance with Laws; Environmental Matters Clause in Contracts

Compliance with Laws; Environmental Matters. (i) Except for failures to be in compliance and failures to have such Permits that individually or in the aggregate have not had and would not reasonably be expected to have a Material Adverse Effect: (A) each of the Company and its Subsidiaries is in compliance with all, and has not violated any, Laws and Orders, including the Federal Food, Drug and Cosmetic Act of 1938, as amended (including the rules and regulations promulgated thereunder, the “FDCA”), the Good Manufacturing Practices and other standards of the Food and Drug Administration, federal Medicare and Medicaid statutes or related state or local statutes or regulations, and the Occupational Safety and Health Act (and the regulations promulgated thereunder), the Fair Labor Standards Act and any other applicable child labor Laws, all applicable import/export Laws, the International Traffic in Arms Regulations (22 C.F.R. §§120-130), and any comparable foreign Laws of any of the foregoing, applicable to it, its properties or other assets or its business or operations, including the Medical Devices Directive of the European Union (the “MDD”) and (B) the Company and each of its Subsidiaries has in effect all approvals, authorizations, certificates, filings, franchises, licenses, notices and permits of or with all Governmental Entities, including all Permits under the FDCA and the MDD, and third persons (collectively, “Permits”) necessary for it to own, lease or operate its properties and other assets and to carry on its business and operations as currently conducted. Neither the Company nor any of its Subsidiaries is 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 is convicted of a criminal offense related to health care. Since January 1, 2004, there has occurred no default under, or violation of, any such Permit, except for any such default or violation that individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. The consummation of the Offer or 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.

Compliance with Laws; Environmental Matters. (i) Except with respect to Environmental Laws, the Employee Retirement Income Security Act of 1974, as amended ("ERISA") and taxes, which are the subjects of Sections 3.01(j)(ii), 3.01(l) and 3.01(n), respectively, and except as set forth in the Filed Company SEC Documents, each of the Company and its Subsidiaries is in compliance with all statutes, laws, ordinances, rules, regulations, judgments, orders and decrees of any Governmental Entity applicable to it, its properties or other assets or its business or operations (collectively, "Legal Provisions"), except for failures to be in compliance and failures to have such Permits that individually or in the aggregate have not had and would not reasonably be expected to have a Material Adverse Effect: (A) each . Each of the Company and its Subsidiaries is in compliance with all, and has not violated any, Laws and Orders, including the Federal Food, Drug and Cosmetic Act of 1938, as amended (including the rules and regulations promulgated thereunder, the “FDCA”), the Good Manufacturing Practices and other standards of the Food and Drug Administration, federal Medicare and Medicaid statutes or related state or local statutes or regulations, and the Occupational Safety and Health Act (and the regulations promulgated thereunder), the Fair Labor Standards Act and any other applicable child labor Laws, all applicable import/export Laws, the International Traffic in Arms Regulations (22 C.F.R. §§120-130), and any comparable foreign Laws of any of the foregoing, applicable to it, its properties or other assets or its business or operations, including the Medical Devices Directive of the European Union (the “MDD”) and (B) the Company and each of its Subsidiaries has in effect all approvals, authorizations, certificates, filings, franchises, licenses, notices and permits of or with all Governmental EntitiesEntities (collectively, "Permits"), including all Permits under the FDCA Federal Food, Drug and Cosmetic Act of 1938, as amended (including the rules and regulations promulgated thereunder, the "FDCA"), and the MDDregulations of the Federal Food and Drug Administration (the "FDA") promulgated thereunder, and third persons (collectively, “Permits”) necessary for it to own, lease or operate its properties and other assets and to carry on its business and operations as presently conducted and as currently proposed by its management to be conducted, except where the failure to have such Permits individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries is 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 is convicted of a criminal offense related to health care. Since January 1, 2004, there There has occurred no default under, or violation of, any such Permit, except for any such default or violation that individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. The consummation of the Offer or the Merger, in and of itself, would not cause the revocation, modification revocation or cancellation of any such Permit that individually or in the aggregate would reasonably be expected to have a Material Adverse Effect. To the Knowledge of the Company, no material action, demand, requirement or investigation by any Governmental Entity and no material suit, action or proceeding by any other person, in each case with respect to the Company or any of its Subsidiaries or any of their respective properties or other assets under any Legal Provision, is pending or threatened.

Compliance with Laws; Environmental Matters. (i) Except with respect to Environmental Laws, the Employee Retirement Income Security Act of 1974, as amended (“ERISA”) and taxes, which are the subjects of Sections 3.01(j)(ii), 3.01(l) and 3.01(n), respectively, and except as set forth in the Filed Company SEC Documents, each of the Company and its Subsidiaries is in compliance with all statutes, laws, ordinances, rules, regulations, judgments, orders and decrees of any Governmental Entity applicable to it, its properties or other assets or its business or operations (collectively, “Legal Provisions”), except for failures to be in compliance and failures to have such Permits that individually or in the aggregate have not had and would not reasonably be expected to have a Material Adverse Effect: (A) each . Each of the Company and its Subsidiaries is has in compliance effect all approvals, authorizations, certificates, filings, franchises, licenses, notices and permits of or with allall Governmental Entities (collectively, and has not violated any, Laws and Orders“Permits”), including all Permits under the Federal Food, Drug and Cosmetic Act of 1938, as amended (including the rules and regulations promulgated thereunder, the “FDCA”), and the Good Manufacturing Practices and other standards regulations of the Federal Food and Drug Administration, federal Medicare and Medicaid statutes or related state or local statutes or regulations, and the Occupational Safety and Health Act (and the regulations promulgated thereunder), the Fair Labor Standards Act and any other applicable child labor Laws, all applicable import/export Laws, the International Traffic in Arms Regulations (22 C.F.R. §§120-130), and any comparable foreign Laws of any of the foregoing, applicable to it, its properties or other assets or its business or operations, including the Medical Devices Directive of the European Union Administration (the “MDDFDA”) and (B) the Company and each of its Subsidiaries has in effect all approvalspromulgated thereunder, authorizations, certificates, filings, franchises, licenses, notices and permits of or with all Governmental Entities, including all Permits under the FDCA and the MDD, and third persons (collectively, “Permits”) necessary for it to own, lease or operate its properties and other assets and to carry on its business and operations as presently conducted and as currently proposed by its management to be conducted, except where the failure to have such Permits individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries is 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 is convicted of a criminal offense related to health care. Since January 1, 2004, there There has occurred no default under, or violation of, any such Permit, except for any such default or violation that individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. The consummation of the Offer or the Merger, in and of itself, would not cause the revocation, modification revocation or cancellation of any such Permit that individually or in the aggregate would reasonably be expected to have a Material Adverse Effect. To the Knowledge of the Company, no material action, demand, requirement or investigation by any Governmental Entity and no material suit, action or proceeding by any other person, in each case with respect to the Company or any of its Subsidiaries or any of their respective properties or other assets under any Legal Provision, is pending or threatened.

Compliance with Laws; Environmental Matters. (i) Except with respect to Environmental Laws, the Employee Retirement Income Security Act of 1974, as amended (“ERISA”) and taxes, which are the subjects of Sections 3.01(j)(ii), 3.01(l) and 3.01(n), respectively, and except as set forth in the Filed Company SEC Documents, each of the Company and its Subsidiaries is in compliance with all statutes, laws, ordinances, rules, regulations, judgments, orders and decrees of any Governmental Entity applicable to it, its properties or other assets or its business or operations (collectively, “Legal Provisions”), except for failures to be in compliance and failures to have such Permits that individually or in the aggregate have not had and would not reasonably be expected to have a Material Adverse Effect: (A) each . Each of the Company and its Subsidiaries is has in compliance effect all approvals, authorizations, certificates, filings, franchises, licenses, notices and permits of or with allall Governmental Entities (collectively, and has not violated any, Laws and Orders“Permits”), including all Permits under the Federal Food, Drug and Cosmetic Act of 1938, as amended (including the rules and regulations promulgated thereunder, the “FDCA”), and the Good Manufacturing Practices and other standards regulations of the Federal Food and Drug Administration, federal Medicare and Medicaid statutes or related state or local statutes or regulations, and the Occupational Safety and Health Act (and the regulations promulgated thereunder), the Fair Labor Standards Act and any other applicable child labor Laws, all applicable import/export Laws, the International Traffic in Arms Regulations (22 C.F.R. §§120-130), and any comparable foreign Laws of any of the foregoing, applicable to it, its properties or other assets or its business or operations, including the Medical Devices Directive of the European Union Administration (the “MDDFDA”) and (B) the Company and each of its Subsidiaries has in effect all approvalspromulgated thereunder, authorizations, certificates, filings, franchises, licenses, notices and permits of or with all Governmental Entities, including all Permits under the FDCA and the MDD, and third persons (collectively, “Permits”) necessary for it to own, lease or operate its properties and other assets and to carry on its business and operations as presently conducted and as currently proposed by its management to be conducted, except where the failure to have such Permits individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. Neither the Company nor any of its Subsidiaries is 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 is convicted of a criminal offense related to health care. Since January 1, 2004, there There has occurred no default under, or violation of, any such Permit, except for any such default or violation that individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. The consummation of the Offer or the Merger, in and of itself, would not cause the revocation, modification revocation or cancellation of any such Permit that individually or in the aggregate would reasonably be expected to have a Material Adverse Effect. No action, demand, requirement or investigation by any Governmental Entity and no suit, action or proceeding by any other person, in each case with respect to the Company or any of its Subsidiaries or any of their respective properties or other assets under any Legal Provision, is pending, or to the Knowledge of the Company, is threatened, except, in each case, as individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect.