Compliance; Regulatory Compliance. Other than tax matters, employee benefits matters, labor and employment matters, environmental matters or intellectual property matters, which are the subjects of Sections 4.10, 4.14, 4.15, 4.16, and 4.17 respectively:
Compliance; Regulatory Compliance. Parent (a) 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 (b) 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 (a) and (b) 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) 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.
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.
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.
Compliance; Regulatory Compliance. Other than tax matters, employee benefits matters, environmental matters or intellectual property matters, which are the subjects of Sections 4.10, 4.13, 4.14 and 4.15, respectively:
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.
Compliance; Regulatory Compliance. (a) Each of Global and the Global Subsidiaries (i) has been operated at all times in compliance with all Laws applicable to Global or any of the Global Subsidiaries or by which any property, business or asset of Global or any of the Global Subsidiaries is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which Global or any of the Global Subsidiaries is a party or by which Global or any of the Global Subsidiaries or any property or asset of Global or any of the Global 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 Material Adverse Effect. Neither Global nor any Global Subsidiary has received any written communication during the past two years from a Governmental Entity that alleges that Global or a Global Subsidiary is not in compliance with any applicable Law, except for failures to be in compliance that, individually or in the aggregate, have not had and are not reasonably expected to have a Material Adverse Effect.
Compliance; Regulatory Compliance. (a) Each of Crown and the Crown Subsidiaries (i) has been operated at all times in compliance with all Laws applicable to Crown or any of the Crown Subsidiaries or by which any property, business or asset of Crown or any of the Crown Subsidiaries is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which Crown or any of the Crown Subsidiaries is a party or by which Crown or any of the Crown Subsidiaries or any property or asset of Crown or any of the Crown 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 Material Adverse Effect. Neither Crown nor any Crown Subsidiary has received any written communication during the past two years from a Governmental Entity that alleges that Crown or a Crown Subsidiary is not in compliance with any applicable Law, except for failures to be in compliance that, individually or in the aggregate, have not had and are not reasonably expected to have a Material Adverse Effect.
