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 viola...
Compliance; Regulatory Compliance. (a) Each of SpectraSite and the SpectraSite Subsidiaries (i) has been operated at all times in compliance with all Laws applicable to SpectraSite or any of the SpectraSite Subsidiaries or by which any property, business or asset of SpectraSite or any of the SpectraSite Subsidiaries is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which SpectraSite or any of the SpectraSite Subsidiaries is a party or by which SpectraSite or any of the SpectraSite Subsidiaries or any property or asset of SpectraSite or any of the SpectraSite 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 would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(b) Each of SpectraSite and the SpectraSite Subsidiaries has in effect all required governmental licenses, permits, certificates, approvals and authorizations necessary for the conduct of their business and the use of their properties and assets, as presently conducted and used, except where such failure has not had, or would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect; and neither SpectraSite nor any SpectraSite Subsidiary has received notice from any Governmental Entity that any such license, permit, certificate, approval or authorization is subject to any adverse action which has had, or would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(c) This Section 3.6 does not relate to tax matters, employee benefits matters, labor relations matters, or environmental matters which are the subjects of Sections 3.9, 3.14, 3.15 and 3.16, respectively.
Compliance; Regulatory Compliance. Parent (i) has been operated at all times in compliance with all Laws and Orders applicable to Parent or by which any property, business or asset of Parent is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which Parent is a party or by which Parent or any property or asset of Parent 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 Parent Material Adverse Effect. Parent has not received any written communication during the past two years from a Governmental Entity that alleges that Parent is not in compliance in any material respect with any applicable Law or Order other than any noncompliance that has not had and is not reasonably expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
Compliance; Regulatory Compliance. Other than FDA matters, Tax matters, employee benefits matters, labor and employment matters, environmental matters or intellectual property matters, which are the subjects of Sections 4.7, 4.10, 4.14, 4.15, 4.16 and 4.17, respectively, 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 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 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 (2) years from a Governmental Entity that alleges that Company is not in compliance in any material respect with any applicable Law and Order.
Compliance; Regulatory Compliance. (a) During the past three (3) years, Menlo (i) has been operated at all times in compliance with all Laws and Orders applicable to Menlo, including, without limitation, all Health Care Laws applicable to Menlo, or by which any property, business or asset of Menlo is bound or affected, (ii) is not in default or violation of any governmental licenses, permits or franchises to which Menlo is a party or by which Menlo or any property or asset of Menlo is bound or affected, and (iii) has not engaged in any activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other governmental healthcare program under any Health Care Law applicable to Menlo other than, in the case of clauses (i), (ii) and (iii) above, failures to comply, defaults or violations which do not have and are not reasonably expected to have, individually or in the aggregate, a Menlo Material Adverse Effect. Menlo has not received any written communication during the past three (3) years from a Governmental Entity that alleges that Menlo is not in compliance in any material respect with any applicable Law or Order, including any Health Care Laws. Menlo is not a party to nor has any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement imposed by any governmental authority.
(b) Neither Menlo nor any of its respective officers, employees, directors, agents or clinical investigators, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of Menlo, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in exclusion or debarment under 42 U.S.C. § 1320a-7 or 21 U.S.C. § 335a.
(c) Each of Menlo, Menlo Merger Sub, 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 FDCA, and the regulations of the FDA promulgated thereunder and any of the foregoing required by any other Regul...
Compliance; Regulatory Compliance. (a) Each of Parent and the Parent Subsidiaries (i) is and has been operated at all times in compliance with all Laws applicable to Parent or any Parent Subsidiary or by which any property, business or asset of Parent or any Parent Subsidiary is bound or affected, including, but not limited to, the federal Food, Drug and Cosmetic Act (“FDCA”) (21 U.S.C § 321 et seq.), the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the Xxxxx Law (42 U.S.C. § 1395nn), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), the exclusion laws, SSA § 1128 (42 U.S.C. § 1320a-7), or the regulations promulgated pursuant to such laws, and comparable state laws, accreditation standards and all other state and federal laws, regulations, manual provisions, policies and administrative guidance relating to the regulation of the business of Parent and the Parent Subsidiaries, and (ii) is not in default or violation of any federal or state governmental licenses, registrations, approvals, authorizations, clearances, exemptions, filings, permits or franchises (collectively, “Permits”) to which Parent or any Parent Subsidiary is a party or by which Parent or any Parent Subsidiary or any property or asset of Parent or any Parent Subsidiary is bound or affected, except, in the case of clauses (a)(i) and (ii) above, for any such failures to comply, defaults, violations or other occurrences which have not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(b) Each of Parent and the Parent Subsidiaries has in effect all material Permits necessary for the conduct of their business and the use of their properties and assets, as presently conducted and used; and except as set forth on Section 4.6 of the Parent Disclosure Letter, neither Parent nor any Parent Subsidiary has received any notice or communication from any Governmental Entity regarding (i) any actual or possible violation of applicable law or any Permit or any failure to comply with any applicable law or the requirements of any Permit, or (ii) any actual or possible revocation, withdrawal, suspension, cancellation, limitation, termination or modification of any Permit; except for any such violation, revocation, withdrawal, suspension, cancellation, limitation, termination or modification which has not had and wo...
Compliance; Regulatory Compliance. (a) Except as set forth in Section 3.6(a) of the Disclosure Schedules, each of Company and Company Subsidiaries (i) has been operated at all times in compliance in all material respects with all Laws applicable to Company or any Company Subsidiary or by which any property, business or asset of Company or any Company Subsidiary is bound or affected and (ii) is not in material default or violation of any material governmental licenses, registrations, permits or franchises to which Company or any Company Subsidiaries is a party or by which Company or any Company Subsidiary or any property or asset of Company or any Company Subsidiaries is bound or affected.
(b) Except as set forth in Section 3.6(b) of the Disclosure Schedules, each of Company and Company Subsidiaries has in effect all required material governmental licenses, registrations, permits, certificates, approvals and authorizations necessary for the conduct of their business and the use of their properties and assets, as presently conducted and used; and neither Company nor any Company Subsidiary has received written notice or, to the Knowledge of Seller, verbal notice from any Governmental Entity that any such material license, permit, certificate, approval or authorization is subject to any adverse action or investigation.
(c) This Section 3.6 does not relate to Tax matters, employee benefits matters, labor relations matters, or environmental matters which are the subjects of Sections 3.9, 3.12, 3.13 and 3.14, respectively.
Compliance; Regulatory Compliance. (a) During the past three (3) years, each of Foamix and the Foamix Subsidiary (i) has been operated at all times in compliance with all Laws and Orders applicable to Foamix or the Foamix Subsidiary, including, without limitation, all Health Care Laws applicable to Foamix or Foamix Subsidiary, or by which any property, business or asset of Foamix or the Foamix Subsidiary is bound or affected, (ii) is not in default or violation of any governmental licenses, permits or franchises to which Foamix or the Foamix Subsidiary is a party or by which Foamix or the Foamix Subsidiary or any property or asset of Foamix or the Foamix Subsidiary is bound or affected, and (iii) has not engaged in any activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other governmental healthcare program under any Health Care Law applicable to Foamix or the Foamix Subsidiary, other than, in the case of clauses (i), (ii) and (iii) above, failures to comply, defaults or violations which do not have and are not reasonably expected to have, individually or in the aggregate, a Foamix Material Adverse Effect. Neither Foamix nor the Foamix Subsidiary has received any written communication during the past three (3) years from a Governmental Entity that alleges that Foamix or the Foamix Subsidiary is not in compliance in any material respect with any applicable Law or Order, including any Health Care Laws. Foamix is not a party to nor has any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement imposed by any governmental authority.
(b) None of Foamix, the Foamix Subsidiary or any of its respective officers, employees, directors, agents or clinical investigators, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the Knowledge of Foamix, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in exclusion or debarment under 42 U.S.C. § 1320a-7 or 21 U.S.C. § 335a.
(c) Each of Foamix and the Foamix Subsidiary has in effect all required filings, licenses, ...
Compliance; Regulatory Compliance. SEC Filings; Financial Statements
Compliance; Regulatory Compliance. 13 SECTION 3.7. SEC FILINGS; FINANCIAL STATEMENTS................................14 SECTION 3.8. ABSENCE OF CERTAIN CHANGES OR EVENTS.............................16 SECTION 3.9. TAXES............................................................16 SECTION 3.10. CHANGE OF CONTROL AGREEMENT; NO EXCESS PARACHUTE PAYMENT........17 SECTION 3.11. LITIGATION......................................................17 SECTION 3.12.
