Compliance; Regulatory Compliance. Other than FDA and related matters, tax matters, employee benefits matters, labor and employment matters, environmental matters or intellectual property matters, which are the subjects of Sections 4.9, 4.10, 4.14, 4.15, 4.16 and 4.17 respectively: (a) The Company (i) has been operated at all times in compliance with all Laws and Orders applicable to the Company or by which any property, business or asset of the Company is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which the Company is a party or by which the Company or any property or asset of the Company is bound or affected other than, in the case of clauses (i) and (ii) above, failures to comply, defaults or violations which do not have and are not reasonably expected to have, individually or in the aggregate, a Company Material Adverse Effect. The Company has not received any written communication during the past two years from a Governmental Entity that alleges that the Company is not in compliance in any material respect with any applicable Law and Order. (b) Each of the Company and its employees and, to the knowledge of the Company, business partners, as applicable, has in effect all required filings, licenses, permits, certificates, exemptions, orders, consents, clearances, registrations, approvals and authorizations of all Governmental Entities (including all authorizations under the regulations of the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the FDA promulgated thereunder and any of the foregoing required by any other Regulatory Authority, including the EMEA and Health Canada) and third Persons necessary for the conduct of the Company’s business and the use of its properties and assets (including the marketing and sale of the Products), as presently conducted and used (the “Company Permits”), and all Company Permits are valid and in full force and effect, except where such failure has not had, or is not reasonably expected to have, individually or in the aggregate, a Company Material Adverse Effect; and the Company has not received written notice from any Governmental Entity or third Person that any such Company Permit is subject to any adverse action which has had, or is reasonably expected to have, individually or in the aggregate, a Company Material Adverse Effect. (c) Neither the Company nor any director, officer, other employee or agent of the Company has materially violated any provision of the Foreign Corrupt Practice Act of 1977, as amended, or any similar foreign Law. (d) Since October 1, 2010, the Company has not made any disclosure (voluntary or otherwise) to any Governmental Entity with respect to any alleged irregularity, misstatement or omission or other potential violation or liability arising under or relating to the Foreign Corrupt Practice Act of 1977, as amended, or any similar Law.
Appears in 3 contracts
Samples: Merger Agreement (Teva Pharmaceutical Industries LTD), Merger Agreement (Nupathe Inc.), Merger Agreement (Nupathe Inc.)
Compliance; Regulatory Compliance. Other than health care regulatory matters, Medicare, Medicaid and legal and billing compliance matters, FDA and related matters, tax matters, employee benefits matters, labor and employment matters, environmental matters or intellectual property matters, which are the subjects of Sections Section 4.7, Section 4.8, Section 4.9, 4.10Section 4.12, 4.14Section 4.17, 4.15Section 4.18, 4.16 Section 4.20 and 4.17 Section 4.21, respectively:
(a) The Each of the Company and the Company Entities (i) has been operated at all times in compliance with all Laws and Orders applicable to the Company or any of the Company Entities or by which any property, business or asset of the Company or any of the Company Entities is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which the Company or any of the Company Entities is a party or by which the Company or any of the Company Entities or any property or asset of the Company or any of the Company Entities is bound or affected other than, in the case of clauses (i) and (ii) above, failures to comply, defaults or violations which do have not have had and are would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. The Neither the Company nor any Company Entity has not received any written communication during the past two (2) years from a Governmental Entity that alleges that the Company or any Company Entity is not in compliance in any material respect with any applicable Law and Order.
(b) Neither the Company nor any Company Entity, nor any of its or their Representatives, acting on their behalf, has, in connection with the operation of their respective businesses, (i) used or promised any funds for unlawful contributions, payments, gifts or entertainment, or made any unlawful expenditures relating to political activity to government officials, candidates or members of political parties or organizations, or established or maintained any unlawful or unrecorded funds in violation of the Foreign Corrupt Practices Act of 1977, as amended, as if it were applicable at that time, or any other similar applicable Law, (ii) paid, promised, accepted or received any unlawful contributions, payments, expenditures, gifts or anything else of value or (iii) violated or operated in noncompliance with any export restrictions, anti-boycott regulations, embargo regulations or other applicable Laws of any Governmental Entity.
(c) Each of the Company, the Company Entities and its their respective employees and, to the knowledge of the Company, business partners, as applicable, has in effect all required filings, licenses, permits, certificates, exemptions, orders, consents, clearances, registrations, approvals and authorizations of all Governmental Entities (including all authorizations under the Social Security Act, as amended, and the regulations of HHS and CMS promulgated thereunder, all authorizations under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the FDA promulgated thereunder thereunder, all authorizations required by any State health care Regulatory Authority, and any of the foregoing required by any other Regulatory Authority, including the EMEA and Health Canada) and third Persons necessary for the conduct of the Company’s and the Company Entities’ business and the use of its their properties and assets (including the marketing and sale of the Products)assets, as presently conducted and used (the “Company Permits”), ) and all Company Permits are valid and in full force and effect, except where such failure has not had, or is and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect; and neither the Company nor any Company Entity has not received oral or written notice from any Governmental Entity or third Person that any such Company Permit is subject to any adverse action which has had, or is would reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(cd) Neither The Company Entities participate in and have not been excluded from the Company nor any directorfederal and state health care programs (individually, officera “Program” and collectively, other employee or agent the “Programs”) listed in Section 4.6(d)(i) of the Company has materially violated any provision Disclosure Letter. A list of all of the Foreign Corrupt Practice Act Company Entities’ existing Medicare and Medicaid Program provider agreements and numbers, and all other federal and state Program provider agreements and numbers, excluding TRICARE and CHAMPUS, pertaining to the business of 1977each Company Entity or, if such agreements do not exist, other documentation evidencing such participation, are set forth in Section 4.6(d)(ii) of the Company Disclosure Letter, current, true and complete copies of which have been delivered or made available to the Parent. The Company Entities’ existing Medicare and Medicaid Program provider agreements and numbers, and all other federal and state Program provider agreements and numbers, including TRICARE and CHAMPUS shall be referred to herein as amended“Program Agreements.”
(e) Section 4.6(e) of the Company Disclosure Letter sets forth a list of each of contractual arrangement between a third party payor, including, but not limited to, private insurance, managed care plans and HMOs (the “Third Party Payors”) and any Company Entity that is reasonably expected to provide for payment of $500,000 or more in calendar year 2010 (the “Third Party Payor Contracts”, and together with the Program Agreements, the “Reimbursement Approvals”). Current, true and complete copies of all Third Party Payor Contracts have been delivered or made available to the Parent. The Program Agreements and Third Party Payor Contracts constitute legal, valid, binding and enforceable obligations of the Company Entity that is a party thereto and the other parties thereto and, to the knowledge of the Company, are in full force and effect. No Company Entity is in default under any similar foreign LawProgram Agreement or under any Third Party Payor Contract to which it is a party and, to the knowledge of the Company, the other parties thereto are not in material default thereunder.
(df) Since October 1The Company and each Company Entity are in material compliance with the rules and policies relating to each Program Agreement and Third Party Payor Contract, 2010including all certification, the Company billing, reimbursement and documentation requirements. No action has not made any disclosure (voluntary or otherwise) to been taken by any Governmental Entity with respect or, to the knowledge of the Company, recommended by any alleged irregularityGovernmental Entity, misstatement either to revoke, withdraw or omission suspend any Program Agreement or to terminate or decertify any participation of any Company Entity in any “Federal Health Care Program” (as that term is defined in 42 U.S.C. § 1320a-7b(f)) in which it participates (including, but not limited to Medicare, Medicaid, TRICARE and CHAMPUS), nor has the Company decided not to renew any Program Agreement. To the knowledge of the Company, no party to a Program Agreement or Third Party Payor Contract or other potential violation Governmental Entity has threatened revocation, suspension, termination, probation, restriction, limitation or liability arising under nonrenewal affecting any Program Agreement or relating to the Foreign Corrupt Practice Act of 1977, as amended, or any similar LawThird Party Payor Contract.
Appears in 2 contracts
Samples: Merger Agreement (Endo Pharmaceuticals Holdings Inc), Merger Agreement (Healthtronics, Inc.)
Compliance; Regulatory Compliance. Other than FDA and related matters, tax matters, employee benefits matters, labor and employment matters, environmental matters or intellectual property matters, which are the subjects of Sections 4.9, 4.10, 4.14, 4.15, 4.16 4.16, and 4.17 respectively:
(a) The Each of the Company and the Company Subsidiaries (i) has been operated at all times in compliance with all Laws and Orders applicable to the Company or any of the Company Subsidiaries or by which any property, business or asset of the Company or any of the Company Subsidiaries is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which the Company or any of the Company Subsidiaries is a party or by which the Company or any of the Company Subsidiaries or any property or asset of the Company or any of the Company Subsidiaries is bound or affected other than, in the case of clauses (i) and (ii) above, failures to comply, defaults or violations which do not have and are not reasonably expected to have, individually or in the aggregate, a Company Material Adverse Effect. The Neither the Company nor any Company Subsidiary has not received any written communication during the past two years from a Governmental Entity that alleges that the Company or a Company Subsidiary is not in compliance in any material respect with any applicable Law and Order.
(b) Each of the Company, the Company Subsidiaries and its their respective employees and, to the knowledge of the Company, business partners, as applicable, has in effect all required filings, licenses, permits, certificates, exemptions, orders, consents, clearances, registrations, approvals and authorizations of all Governmental Entities (including all authorizations under the regulations of the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the FDA promulgated thereunder and any of the foregoing required by any other Regulatory Authority, including the EMEA and Health Canada) and third Persons necessary for the conduct of the Company’s and the Company Subsidiaries’ business and the use of its their properties and assets (including the marketing and sale of the Products), as presently conducted and used (the “Company Permits”), and all Company Permits are valid and in full force and effect, except where such failure has not had, or is not reasonably expected to have, individually or in the aggregate, a Company Material Adverse Effect; and neither the Company nor any Company Subsidiary has not received written notice from any Governmental Entity or third Person that any such Company Permit is subject to any adverse action which has had, or is reasonably expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) Neither the Company nor any director, officer, other employee or agent of the Company has materially violated any provision of the Foreign Corrupt Practice Act of 1977, as amended, or any similar foreign Law.
(d) Since October 1, 2010, the Company has not made any disclosure (voluntary or otherwise) to any Governmental Entity with respect to any alleged irregularity, misstatement or omission or other potential violation or liability arising under or relating to the Foreign Corrupt Practice Act of 1977, as amended, or any similar Law.
Appears in 2 contracts
Samples: Merger Agreement (Indevus Pharmaceuticals Inc), Merger Agreement (Endo Pharmaceuticals Holdings Inc)
Compliance; Regulatory Compliance. Other than FDA and related matters, tax matters, employee benefits healthcare regulatory compliance matters, labor and employment matters, employee benefits matters, tax matters, hazardous materials and environmental matters or intellectual property matters, which are the subjects of Sections 4.9Section 4.01(j), 4.10Section 4.01(k), 4.14Section 4.01(l), 4.15Section 4.01(n), 4.16 and 4.17 Section 4.01(o), Section 4.01(p), Section 4.01(t), respectively:
(ai) The Each of the Company and the Company’s Subsidiaries (i) has been operated at all times in compliance with all Laws and Orders Judgments applicable to the Company or any of the Company’s Subsidiaries or by which any property, business or asset of the Company or any of the Company’s Subsidiaries is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which the Company or any of the Company’s Subsidiaries is a party or by which the Company or any of the Company’s Subsidiaries or any property or asset of the Company or any of the Company’s Subsidiaries is bound or affected other than, in the case of clauses (i) and (ii) above, failures to comply, defaults or violations which do have not have had and are would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. The Neither the Company nor any of the Company’s Subsidiaries has not received any written communication during notice or Claim nor has any Claim been commenced or, to the past two years from a Governmental Entity Company’s Knowledge, brought, initiated, or threatened against the Company or any Subsidiary of the Company, that alleges that the Company or any of its Subsidiaries is not in compliance in any material respect with any applicable Law and Orderor Judgment.
(bii) Neither the Company nor any of the Company’s Subsidiaries, nor any of its or their Representatives, acting on their behalf, has, in connection with the operation of their respective businesses, (i) used or promised any funds for unlawful contributions, payments, gifts or entertainment, or made any unlawful expenditures relating to political activity to government officials, candidates or members of political parties or organizations, or established or maintained any unlawful or unrecorded funds in violation of the Foreign Corrupt Practices Act of 1977, as amended, as if it were applicable at that time, or any other similar applicable Law, (ii) paid, promised, accepted or received any unlawful contributions, payments, expenditures, gifts or anything else of value, or (iii) violated or operated in noncompliance with any export restrictions, anti-boycott regulations, embargo regulations or other applicable Laws of any Governmental Entity. During the last three years, neither the Company nor any Subsidiary of the Company has received any written communication that alleges that the Company or any Subsidiary of the Company, or any director, officer, agent, employee or other Person action on behalf of the Company or any Subsidiary of the Company, is in violation of, or has any material Liability under, the Foreign Corrupt Practices Act of 1977, as amended.
(iii) Each of the Company and its employees and, to the knowledge of the Company, business partners, as applicable, ’s Subsidiaries has in effect all required filings, licenses, permits, certificates, exemptions, orders, consents, clearances, registrations, approvals and authorizations of all Governmental Entities (including all authorizations under the regulations of the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the FDA promulgated thereunder and any of the foregoing required by any other Regulatory Authority, including the EMEA and Health Canada) and third Persons necessary for the conduct of the Company’s and the Company’s Subsidiaries’ business and the use of its their properties and assets (including the marketing and sale of the Products)assets, as presently conducted and used (the “Company Permits”), and all Company Permits are valid and in full force and effect, except where such failure has not had, or is not reasonably expected to have, individually or effect in the aggregate, a Company Material Adverse Effect; and all material respects. Neither the Company nor any of the Company’s Subsidiaries has not received written notice from any Governmental Entity or third Person that any such Company Permit is subject to any adverse action which has had, or is reasonably expected to have, individually or in the aggregate, a Company Material Adverse Effectaction.
(c) Neither the Company nor any director, officer, other employee or agent of the Company has materially violated any provision of the Foreign Corrupt Practice Act of 1977, as amended, or any similar foreign Law.
(d) Since October 1, 2010, the Company has not made any disclosure (voluntary or otherwise) to any Governmental Entity with respect to any alleged irregularity, misstatement or omission or other potential violation or liability arising under or relating to the Foreign Corrupt Practice Act of 1977, as amended, or any similar Law.
Appears in 2 contracts
Samples: Merger Agreement (Stryker Corp), Merger Agreement (Orthovita Inc)
Compliance; Regulatory Compliance. Other than FDA and related matters, tax matters, employee benefits matters, labor and employment matters, environmental matters or intellectual property matters, which are the subjects of Sections 4.9, 4.10, 4.14, 4.15, 4.16 4.16, and 4.17 respectively:
(a) The Each of the Company and the Company Subsidiaries (i) has been operated at all times in compliance with all Laws and Orders applicable to the Company or any of the Company Subsidiaries or by which any property, business or asset of the Company or any of the Company Subsidiaries is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which the Company or any of the Company Subsidiaries is a party or by which the Company or any of the Company Subsidiaries or any property or asset of the Company or any of the Company Subsidiaries is bound or affected other than, in the case of clauses (i) and (ii) above, failures to comply, defaults or violations which do not have and are not reasonably expected to have, individually or in the aggregate, a Company Material Adverse Effect. The Neither the Company nor any Company Subsidiary has not received any written communication during the past two years from a Governmental Entity that alleges that the Company or a Company Subsidiary is not in compliance in any material respect with any applicable Law and Order.
(b) Each of the Company, the Company Subsidiaries and its their respective employees and, to the knowledge of the Company, business partners, as applicable, has in effect all required filings, licenses, permits, certificates, exemptions, orders, consents, clearances, registrations, approvals and authorizations of all Governmental Entities (including all authorizations under the regulations of the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “"FDCA”"), and the regulations of the FDA promulgated thereunder and any of the foregoing required by any other Regulatory Authority, including the EMEA and Health Canada) and third Persons necessary for the conduct of the Company’s 's and the Company Subsidiaries' business and the use of its their properties and assets (including the marketing and sale of the Products), as presently conducted and used (the “"Company Permits”"), and all Company Permits are valid and in full force and effect, except where such failure has not had, or is not reasonably expected to have, individually or in the aggregate, a Company Material Adverse Effect; and neither the Company nor any Company Subsidiary has not received written notice from any Governmental Entity or third Person that any such Company Permit is subject to any adverse action which has had, or is reasonably expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) Neither the Company nor any director, officer, other employee or agent of the Company has materially violated any provision of the Foreign Corrupt Practice Act of 1977, as amended, or any similar foreign Law.
(d) Since October 1, 2010, the Company has not made any disclosure (voluntary or otherwise) to any Governmental Entity with respect to any alleged irregularity, misstatement or omission or other potential violation or liability arising under or relating to the Foreign Corrupt Practice Act of 1977, as amended, or any similar Law.
Appears in 1 contract
Samples: Merger Agreement (Endo Pharmaceuticals Holdings Inc)
Compliance; Regulatory Compliance. Other than FDA and related matters, tax matters, employee benefits matters, labor and employment matters, environmental matters or intellectual property matters, which are the subjects of Sections 4.9, 4.10, 4.144.13, 4.14 and 4.15, 4.16 and 4.17 respectively:
(a) The Company Each of Parent and the Parent Subsidiaries (i) has been operated at all times in compliance with all Laws and Orders applicable to Parent or any of the Company Parent Subsidiaries or by which any property, business or asset of Parent or any of the Company Parent Subsidiaries is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which Parent or any of the Company Parent Subsidiaries is a party or by which Parent or any of the Company Parent Subsidiaries or any property or asset of Parent or any of the Company Parent Subsidiaries is bound or affected other than, in the case of clauses (i) and (ii) above, failures to comply, defaults or violations which do not have and are not reasonably expected to have, individually or in the aggregate, a Company Parent Material Adverse Effect. The Company Neither Parent nor any Parent Subsidiary has not received any written communication during the past two years from a Governmental Entity that alleges that the Company Parent or a Parent Subsidiary is not in compliance in any material respect with any applicable Law and or Order.
(b) Each of Parent and the Company Parent Subsidiaries and its their respective employees and, to the knowledge of the CompanyParent’s knowledge, business partnersParent Partners (as defined below), as applicable, has in effect all required filings, licenses, permits, certificates, exemptions, orders, consents, clearances, registrations, approvals and authorizations of all Governmental Entities (including all authorizations under the regulations of the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the FDA promulgated thereunder and any of the foregoing required by any other Regulatory Authority, including the EMEA and Health Canada) and third Persons necessary for the conduct of the Company’s their business and the use of its their properties and assets (including the marketing and sale of the Products)assets, as presently conducted and used (the “Company Permits”), and all Company Permits are valid and in full force and effectused, except where such failure has not had, or is not reasonably expected to have, individually or in the aggregate, a Company Parent Material Adverse Effect; and the Company neither Parent nor any Parent Subsidiary has not received written notice from any Governmental Entity or third Person that any such Company Permit license, permit, certificate, approval or authorization is subject to any adverse action which has had, or is reasonably expected to have, individually or in the aggregate, a Company Parent Material Adverse Effect.
(c) Neither the Company nor any director, officer, other employee or agent of the Company has materially violated any provision of the Foreign Corrupt Practice Act of 1977, as amended, or any similar foreign Law.
(d) Since October 1, 2010, the Company has not made any disclosure (voluntary or otherwise) to any Governmental Entity with respect to any alleged irregularity, misstatement or omission or other potential violation or liability arising under or relating to the Foreign Corrupt Practice Act of 1977, as amended, or any similar Law.
Appears in 1 contract
Compliance; Regulatory Compliance. Other than FDA and related matters, tax matters, employee benefits matters, labor and employment relations matters, environmental matters or intellectual property matters, which are the subjects of Sections 4.93.10, 4.103.14, 4.143.15, 4.153.16, 4.16 and 4.17 3.17 respectively:
(a) The Each of the Company and the Company Subsidiaries (i) has been operated at all times in compliance with all Laws and Orders applicable to the Company or any of the Company Subsidiaries or by which any property, business or asset of the Company or any of the Company Subsidiaries is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which the Company or any of the Company Subsidiaries is a party or by which the Company or any of the Company Subsidiaries or any property or asset of the Company or any of the Company Subsidiaries is bound or affected other than, in the case of clauses (i) and (ii) above, failures to comply, defaults or violations which do not have and are not reasonably expected to have, individually or in the aggregate, a Company Material Adverse Effect. The Neither the Company nor any Company Subsidiary has not received any written communication during the past two years from a Governmental Entity that alleges that the Company or a Company Subsidiary is not in compliance in any material respect with any applicable Law and Order.
(b) Each of the Company, the Company Subsidiaries and its their respective employees and, to the knowledge of the Company’s knowledge, business partners, as applicable, has in effect all required filings, licenses, permits, certificates, exemptions, orders, consents, clearances, registrations, approvals and authorizations of all Governmental Entities (including all authorizations under the regulations of the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the FDA promulgated thereunder and any of the foregoing required by any other Regulatory Authority, including the EMEA and Health Canada) and third Persons necessary for the conduct of the Company’s and the Company Subsidiaries’ business and the use of its their properties and assets (including the marketing and sale of the Products), as presently conducted and used (the “Company Permits”), and all Company Permits are valid and in full force and effect, except where such failure has not had, or is not reasonably expected to have, individually or in the aggregate, a Company Material Adverse Effect; and neither the Company nor any Company Subsidiary has not received written notice from any Governmental Entity or third Person that any such Company Permit is subject to any adverse action which has had, or is reasonably expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) Neither the Company nor any director, officer, other employee or agent of the Company has materially violated any provision of the Foreign Corrupt Practice Act of 1977, as amended, or any similar foreign Law.
(d) Since October 1, 2010, the Company has not made any disclosure (voluntary or otherwise) to any Governmental Entity with respect to any alleged irregularity, misstatement or omission or other potential violation or liability arising under or relating to the Foreign Corrupt Practice Act of 1977, as amended, or any similar Law.
Appears in 1 contract
Compliance; Regulatory Compliance. Other than FDA labor and related matters, tax employment matters, employee benefits matters, labor and employment tax matters, environmental matters or intellectual property matters, which are the subjects of Sections 4.9Section 4.01(j), 4.10Section 4.01(l), 4.14Section 4.01(m), 4.15Section 4.01(n) and Section 4.01(r), 4.16 and 4.17 respectively:
(ai) The Each of the Company and the Company’s Subsidiaries (i) has been operated at all times in compliance with all Laws and Orders Judgments applicable to the Company or any of the Company’s Subsidiaries or by which any property, business or asset of the Company or any of the Company’s Subsidiaries is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which the Company or any of the Company’s Subsidiaries is a party or by which the Company or any of the Company’s Subsidiaries or any property or asset of the Company or any of the Company’s Subsidiaries is bound or affected other than, in the case of clauses (i) and (ii) above, failures to comply, defaults or violations which do have not have had and are would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. The Neither the Company nor any of the Company’s Subsidiaries has not received any written communication during the past two years year from a Governmental Entity that alleges that the Company or any of its Subsidiaries is not in compliance in any material respect with any applicable Law and Orderor Judgment.
(bii) To the Company’s Knowledge, neither the Company nor any of the Company’s Subsidiaries, nor any of its or their Representatives, acting on their behalf, has, in connection with the operation of their respective businesses, (i) used or promised any funds for unlawful contributions, payments, gifts or entertainment, or made any unlawful expenditures relating to political activity to government officials, candidates or members of political parties or organizations, or established or maintained any unlawful or unrecorded funds in violation of the Foreign Corrupt Practices Act of 1977, as amended, as if it were applicable at that time, or any other similar applicable Law, (ii) paid, promised, accepted or received any unlawful contributions, payments, expenditures, gifts or anything else of value, or (iii) violated or operated in noncompliance with any export restrictions, anti-boycott regulations, embargo regulations or other applicable Laws of any Governmental Entity.
(iii) Each of the Company and its employees and, to the knowledge of the Company, business partners, as applicable, ’s Subsidiaries has in effect all required filings, licenses, permits, certificates, exemptions, orders, consents, clearances, registrations, approvals and authorizations of all Governmental Entities (including all authorizations under the regulations of the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the FDA promulgated thereunder and any of the foregoing required by any other Regulatory Authority, including the EMEA and Health Canada) and third Persons necessary for the conduct of the Company’s and the Company’s Subsidiaries’ business and the use of its their properties and assets (including the marketing and sale of the Products)assets, as presently conducted and used (the “Company Permits”), ) and all Company Permits are valid and in full force and effect, except where such failure has not had, or is and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect; and . Neither the Company nor any of the Company’s Subsidiaries has not received written notice from any Governmental Entity or third Person that any such Company Permit is subject to any adverse action which has had, or is would reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) Neither the Company nor any director, officer, other employee or agent of the Company has materially violated any provision of the Foreign Corrupt Practice Act of 1977, as amended, or any similar foreign Law.
(d) Since October 1, 2010, the Company has not made any disclosure (voluntary or otherwise) to any Governmental Entity with respect to any alleged irregularity, misstatement or omission or other potential violation or liability arising under or relating to the Foreign Corrupt Practice Act of 1977, as amended, or any similar Law.
Appears in 1 contract