Common use of Compliance; Regulatory Compliance Clause in Contracts

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. (a) Each of SpectraSite ATC and the SpectraSite ATC Subsidiaries (i) has been operated at all times in compliance with all Laws applicable to SpectraSite ATC or any of the SpectraSite ATC Subsidiaries or by which any property, business or asset of SpectraSite ATC or any of the SpectraSite ATC Subsidiaries is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which SpectraSite ATC or any of the SpectraSite ATC Subsidiaries is a party or by which SpectraSite ATC or any of the SpectraSite ATC Subsidiaries or any property or asset of SpectraSite ATC or any of the SpectraSite ATC 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 ATC and the SpectraSite ATC 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 ATC nor any SpectraSite ATC 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 4.6 does not relate to tax matters, employee benefits matters, labor relations matters, or environmental matters which are the subjects of Sections 3.94.9, 3.144.14, 3.15 4.15 and 3.164.16, respectively.

Compliance; Regulatory Compliance. (a) Each of SpectraSite Global and the SpectraSite Global Subsidiaries (i) has been operated at all times in compliance with all Laws applicable to SpectraSite Global or any of the SpectraSite Global Subsidiaries or by which any property, business or asset of SpectraSite Global or any of the SpectraSite Global Subsidiaries is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which SpectraSite Global or any of the SpectraSite Global Subsidiaries is a party or by which SpectraSite Global or any of the SpectraSite Global Subsidiaries or any property or asset of SpectraSite Global or any of the SpectraSite 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 would are not reasonably be 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. (b) Each of SpectraSite Global and the SpectraSite Global 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 is not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect; and neither SpectraSite Global nor any SpectraSite Global 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 is reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. (c) This Section 3.6 does not relate to tax Tax matters, employee benefits matters, labor relations matters, environmental matters, intellectual property matters or environmental matters related to the Foreign Corrupt Practices Act and international trade sanctions, which are the subjects of Sections 3.9, 3.14, 3.15 3.15, 3.16, 3.17 and 3.163.21, respectively.

Compliance; Regulatory Compliance. (a) Each of SpectraSite Crown and the SpectraSite Crown Subsidiaries (i) has been operated at all times in compliance with all Laws applicable to SpectraSite Crown or any of the SpectraSite Crown Subsidiaries or by which any property, business or asset of SpectraSite Crown or any of the SpectraSite Crown Subsidiaries is bound or affected and (ii) is not in default or violation of any governmental licenses, permits or franchises to which SpectraSite Crown or any of the SpectraSite Crown Subsidiaries is a party or by which SpectraSite Crown or any of the SpectraSite Crown Subsidiaries or any property or asset of SpectraSite Crown or any of the SpectraSite 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 would are not reasonably be 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. (b) Each of SpectraSite Crown and the SpectraSite Crown 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 is not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect; and neither SpectraSite Crown nor any SpectraSite Crown 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 is reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. (c) This Section 3.6 4.6 does not relate to tax Tax matters, employee benefits matters, labor relations matters, or environmental matters or matters related to the Foreign Corrupt Practices Act and international trade sanctions, which are the subjects of Sections 3.94.9, 3.14, 3.15 4.13 and 3.164.16, respectively.

Compliance; Regulatory Compliance. (a) Each of SpectraSite the Company and the SpectraSite Subsidiaries (i) is and has been operated at all times in material compliance with all Laws applicable to SpectraSite the Company or any of the SpectraSite Subsidiaries or by which any property, business or asset Asset of SpectraSite the Company or any of the SpectraSite Subsidiaries is bound or affected to which it is subject and (ii) is not in material default or violation of any federal or state governmental licenses, registrations, approvals, authorizations, exemptions filings, permits or franchises (collectively, “Permits”) to which SpectraSite the Company 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 Effectparty. (b) Each of SpectraSite the Company and the SpectraSite Subsidiaries has in effect all required governmental licenses, permits, certificates, approvals and authorizations material Permits necessary for the conduct of their business and the use of their properties and assets, Business as presently conducted and usedconducted. Except as set forth in Section 4.24(b) of the Company Disclosure Letter, except where such failure has not had, or would not reasonably be expected to have, individually or in neither the aggregate, a Material Adverse Effect; and neither SpectraSite Company nor any SpectraSite Subsidiary has received any written notice or communication from any Governmental Entity Authority asserting or alleging that it has failed to comply with applicable Law or the requirements of any such licensePermit, permitor, certificateto the Company’s Knowledge, approval threatening or authorization is subject to asserting any adverse action which has hadactual or possible revocation, withdrawal, cancellation, suspension, termination or modification of any Permit, and there are no facts or circumstances that would reasonably be expected to havegive rise to any such notice or communication. Except as set forth on Section 4.24(b) of the Company Disclosure Letter, individually to the Company’s Knowledge, no such Permit will be terminated or impaired, or will become terminable, in whole or in part, as a result of the aggregate, a Material Adverse Effectconsummation of the transaction contemplated by this Agreement. (c) This Except as set forth in Section 3.6 does 4.24(c) of the Company Disclosure Letter, (i) the Company meets, in all material respects, all of the requirements of participation and payment of Medicare, Medicaid, any other state or federal government health care programs, and any other public or private third party payor programs (collectively, “Programs”) that the Company participates in or receives payment from, (ii) the Company is not relate to tax mattersor has not been excluded from participation in any Programs, employee benefits matters(iii) there is no audit, labor relations mattersclaim review, or environmental matters other Action pending or, to the Company’s Knowledge, threatened which could result in the imposition of penalties or the exclusion of the Company from any Program and the Company has not received notice of any such audit, claim review or other Action, and (iv) all reports, documents, claims, and notices required to be filed, maintained or furnished to any U.S. Governmental Authority by the Company under any Programs have been so filed, maintained or furnished and all such reports, documents, claims and notices were complete and correct on the date filed (or were corrected or supplemented by a subsequent filing). None of the Subsidiaries of the Company participate in or receive payment from any Program. (d) To the Company’s Knowledge, the Company and the Subsidiaries’ manufacturers, suppliers, distributors and third party contractors, currently and at all times have manufactured, marketed, imported, exported, tested, developed, processed, packaged, labeled, stored, and distributed their products in compliance with all applicable Laws, including federal statutes, and rules and regulations promulgated by the United states Food and Drug Administration (“FDA”). All of the products currently marketed by the Company and the Subsidiaries in the United States have been approved for sale by the FDA. In addition, the Company and the Subsidiaries and, to the Company’s Knowledge, any third party manufacturer of Company products are in material compliance with all FDA requirements applicable to the subjects Business, including the registration and listing requirements set forth in 21 C.F.R. part 207. Neither the Company nor the Subsidiaries, nor, to the Company’s Knowledge any third party manufacturers have received any notice from, or otherwise have knowledge of, the FDA or any other U.S. Governmental Authority, questioning or alleging violations with respect to its manufacturing practices, or threatening to limit, suspend, or revoke any product approval, change the marketing classification or labeling of, or otherwise require market removal or withdrawal of Sections 3.9any of the Company’s products. Except as set forth on Section 4.24(d) of the Company Disclosure Letter, 3.14neither the Company nor the Subsidiaries have received, 3.15 and 3.16to the Company’s Knowledge, respectivelythere are no facts that furnish any basis for, any Form FDA-483 notice of inspectional observations, warning letters, untitled letters or other correspondence or notice from the FDA, or any applicable U.S. Governmental Authority alleging or asserting noncompliance with any applicable Laws or Permits; and there have been no voluntary or involuntary recalls, corrective actions, removals, field notifications, import alerts, product detentions, product seizures, governmental investigations, or civil or criminal enforcement action initiated relating to the products or the Company or the Subsidiaries. There has been no false information or material omission in any product application to the FDA by the Company or any Subsidiary. All United States regulatory approvals for the products currently marketed by the Company and the Subsidiaries are exclusively owned by and registered in the name of the Company or one of the Subsidiaries and are in full force and effect. (e) To the Company’s Knowledge, all studies, tests, pre-clinical and clinical trials conducted by or on behalf of the Company and the Subsidiaries have been, and are being conducted in all material respects in compliance with applicable Laws, protocols, procedures, controls, rules, regulations and guidelines, including, if applicable, those promulgated by the FDA relating thereto, including the federal Food, Drug and Cosmetic Act (21 U.S.C. § 321 et seq.) and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312. (f) Except as set forth in Section 4.24(f) of the Company Disclosure Letter, neither the Company, nor any Subsidiary nor any current manager, officer or employee of the Company or any Subsidiary has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under 21 U.S.C. Section 335a or any similar state Law.