Common use of Governmental Authorizations and Regulations Clause in Contracts

Governmental Authorizations and Regulations. (a) Except as set forth in Schedule 4.13, the Company and each Subsidiary has complied and are currently in compliance with each law, ordinance or governmental or regulatory rule or regulation, whether federal, state, local or foreign to which such entity's business, operations, assets or properties is subject ("Regulations"), except for items of non-compliance (i) which were identified on a survey report with respect to such Provider, are being cured by the applicable Provider pursuant to a plan of correction accepted by the applicable governmental authority, and will not result in the loss or suspension of, or other action affecting, any Authorization (as defined below) of the applicable Provider, (ii) are not reasonably likely to materially and adversely affect the business of any Provider, and (iii) which would not, individually or in the aggregate, have a Material Adverse Effect. Except as set forth in Schedule 4.13, each of the Company and the Subsidiaries (or, where required under applicable law, to the knowledge of the Company, the Managed Providers) owns, holds, possesses or lawfully uses in the operation of its business all applicable Authorizations, other than Authorizations which (i) are not necessary to continue the operation of the business of such Provider in substantially the same manner as it currently operates and has operated heretofore, or (ii) if not owned, held, possessed or lawfully used by the Company or such Subsidiary (or by the applicable Managed Provider), would not, individually or in the aggregate, have a Material Adverse Effect. As used herein, "Authorizations" means all licenses, permits, certificates of need, qualifications, registrations, certifications, provider agreements and other authorizations of any governmental authority which are required under applicable Regulations for a Provider to conduct its business and obtain payment for services and goods provided by it under the Federal Medicare program, the state Medicaid program for each state in which such Provider operates (the "Applicable Medicaid Programs"), and any other governmental programs for payment of health care services or goods in which such Provider purports to participate, other than any of the foregoing which are not material to the business and operations of the relevant Provider, the Company or any Subsidiary. Except as set forth in Schedule 4.13, all of the Authorizations owned, held, possessed or lawfully used by the Company or its Subsidiaries (or, where required under applicable law, to the knowledge of the Company, the Managed Providers) are valid and in good standing, non-probationary, non-provisional and in full force and effect. Except as set forth in Schedule 4.13, none of the Providers is subject to any governmental restrictions on its operations (e.g., due to prior survey deficiencies) which adversely affects the conduct of its business, other than restrictions which apply to all providers of the services or goods furnished by such Provider in the relevant jurisdiction. Except as set forth in Schedule 4.13, there are no actions or proceedings to revoke, withdraw, terminate or suspend any Authorization, neither the Company nor any of its Subsidiaries has received any notice or other communication threatening any of the foregoing (other than notices and communications which have been withdrawn or otherwise resolved), nor does the Company have any knowledge of any reason why any Authorization is likely not to be renewed by the applicable governmental authority in the ordinary course.

Governmental Authorizations and Regulations. (a) Except To the knowledge of the Company, and except as set forth in Schedule 4.13Section 3.15 of the Disclosure Schedule, the Company and each Subsidiary has complied and are is currently in compliance with each each, and is not in violation of any, law, ordinance ordinance, or governmental or regulatory xxxxxx xxxx rule or regulation, whether federal, state, local or foreign foreign, to which such entity's business, operations, assets or properties is subject ("Regulations"), except for items of non-compliance (i) which were identified on a survey report with respect to where such Provider, are being cured by the applicable Provider pursuant to a plan of correction accepted by the applicable governmental authority, and will not result in the loss or suspension of, or other action affecting, any Authorization (as defined below) of the applicable Provider, (ii) are noncompliance could not reasonably likely be expected to materially and adversely affect the business of any Provider, and (iii) which would not, individually or in the aggregate, have a Material Adverse Effect. Except as set forth in Schedule 4.13Section 3.15 of the Disclosure Schedule, each of the Company and the Subsidiaries (or, where required under applicable law, to the knowledge of the Company, the Managed Providers) each Subsidiary owns, holds, possesses or lawfully uses in the operation of its business all material franchises, licenses, permits, certificates of need ("CON"), provider agreements and certifications under Subchapters XVIII and XIX of the Social Security Act (the "Social Security Act"; the reimbursement programs promulgated under such Subchapters are hereinafter referred to as the "Medicare and Medicaid Programs") and any other applicable laws for reimbursement for long-term, skilled and intermedi ate nursing care, or other type of care provided at each Facility, easements, rights, applications, filings, registrations and other authorizations ("Authorizations") which are in any manner necessary for it to conduct its business as now or previously conducted or for the ownership and use of the assets owned or used by the Company and such Subsidiary or any Professional in the conduct of the Business, free and clear of all liens, claims, charges, restrictions and encumbrances and in substantial compliance with all Regulations, other than any such Authorizations which (i) are not necessary to continue the operation of the business of such Provider in substantially the same manner as it currently operates and has operated heretoforewhich, or (ii) if not owned, held, possessed or lawfully used by the Company or such Subsidiary (or by the applicable Managed Provider)and each Subsidiary, would not, not individually or in the aggregate, aggregate have a Material Adverse Effect. As used hereinNeither the Company nor any Subsidiary is in default, "Authorizations" means all licenses, permits, certificates of need, qualifications, registrations, certifications, provider agreements and other authorizations of any governmental authority which are required under applicable Regulations for a Provider to conduct its business and obtain payment for services and goods provided by it under the Federal Medicare program, the state Medicaid program for each state in which such Provider operates (the "Applicable Medicaid Programs"), and any other governmental programs for payment of health care services or goods in which such Provider purports to participate, other than any of the foregoing which are not material to the business and operations of the relevant Provider, nor has the Company or any SubsidiarySubsidiary received any notice of any claim of default, with respect to any such Authorization. Except as set forth in Schedule 4.13, all Section 3.15 of the Authorizations ownedDisclosure Schedule, held, possessed or lawfully used by neither the Company nor any Subsidiary has been informed in writing that any action currently is pending by any governmental or its Subsidiaries (orregulatory official, where required under applicable lawbody or authority, either to revoke, withdraw or suspend any CON or any license to operate any of the Facilities, or to terminate or decertify any participation of any of the Facilities or Professionals in the Medicare and Medicaid Programs, nor, to the knowledge of the Company, the Managed Providers) are valid and in good standing, non-probationary, non-provisional and in full force and effect. Except as set forth in Schedule 4.13, none of the Providers is subject there any decision not to renew any provider agreement related to any governmental restrictions on its operations (e.g.Facility. As used herein, due to prior survey deficiencies) which adversely affects the conduct of its business, other than restrictions which apply to all providers of the services term "Professional" means any individual who is employed by or goods furnished by such Provider in the relevant jurisdiction. Except as set forth in Schedule 4.13, there are no actions or proceedings to revoke, withdraw, terminate or suspend any Authorization, neither under contract with the Company nor or any of its Subsidiaries has received Subsidiary to provide health care services for which a license or permit is required by any notice federal, state or other communication threatening any of the foregoing (other than notices and communications which have been withdrawn or otherwise resolved), nor does the Company have any knowledge of any reason why any Authorization is likely not to be renewed by the applicable governmental authority in the ordinary courselocal law.

Governmental Authorizations and Regulations. ‌ (a) Except as set forth in on Schedule 4.133.13(a) of the Company Disclosure Schedule, the Company and each the Subsidiary have all applications, licenses, permits, approvals, authorizations, clearances, registrations, certificates, filings, consents or orders, and supplements or amendments thereto, filed with or issued or granted by, any Governmental Entity (including permits issued under the FDA Act) (collectively, the “Permits”) required for the operation of the Business as currently conducted, the holding of any interest in any of its properties and assets, and the operation of its facilities. The operation of the Business is in substantial compliance with all such Permits, and all of such Permits are in full force and effect. (b) All Existing Products manufactured, marketed, sold or distributed by the Seller Parties in the United States have been granted 510(k) clearance by the FDA or do not require separate 510(k) clearance and documentation of such has been internally maintained. No Existing Product is or was, at the time of any introduction, an article that is or was prohibited from introduction into interstate commerce under the FDA Act, including Sections 301, 501, 502, 510, 515 or 801 thereof. The Company or the Subsidiary has complied obtained in all countries where the Company or the Subsidiary is marketing or has marketed Existing Products, all applicable Permits regulating the safety, effectiveness, and market clearance of the Existing Products that are currently marketed by the Company or the Subsidiary. Schedule 3.13(b) of the Company Disclosure Schedule sets forth a list of all of the Company’s and the Subsidiary’s Permits regarding testing, market clearance, safety and effectiveness of the Existing Products. (c) The Company and the Subsidiary are in compliance in all material respects with the FDA’s registration and listing requirements to the extent required by applicable Law, and the Existing Products, if so required, have been manufactured in all material respects in accordance with the Good Manufacturing Practice requirements in the FDA Act and the Quality System Regulations promulgated by the FDA, and are currently in conformance in all material respects with all applicable CE Marking certifications. The Existing Products have been manufactured in all material respects in accordance with the Company’s specifications. The Existing Products have not been adulterated or misbranded within the meaning of the FDA Act, or within the meaning of any applicable Law. The Company and the Subsidiary are in compliance in all material respects with each lawthe Laws, ordinance or governmental or regulatory rule or regulation, whether federal, state, local or foreign procedures and specifications applicable to which such entity's business, operations, assets or properties is subject ("Regulations"), except for items of non-compliance (i) which were identified on a survey report them with respect to such Providerthe development, are being cured design, manufacture, processing, storage, import, export, distribution, packaging, labeling, testing, inspection, marketing and sales of the Existing Products promulgated by any Governmental Entity that has jurisdiction over the Company in a state, country or territory where the Company manufactures, sells or markets the Existing Products. The Company and the Subsidiary have not received any written notice, or to the Knowledge of the Seller Parties, any non-written notice, from any Governmental Entity alleging or asserting noncompliance with any applicable Provider pursuant to a plan of correction accepted by the applicable governmental authorityLaws or Permits, and will not result in the loss Seller Parties have no Knowledge or suspension of, or other action affecting, reason to believe that any Authorization Governmental Entity is considering such action. (as defined belowd) of the applicable Provider, (ii) are not reasonably likely to materially and adversely affect the business of any Provider, and (iii) which would not, individually or in the aggregate, have a Material Adverse Effect. Except as set forth in Schedule 4.133.13(d) of the Company Disclosure Schedule, each the Company and the Subsidiary have never conducted any voluntary or mandatory recalls, field notifications, field corrections, market withdrawals, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of any Existing Products (collectively, “Recall”) and to the Seller Parties’ Knowledge, there is not pending any investigation or other action of any Governmental Entity, or any other information, that is reasonably likely to result in a Recall action. (e) All studies, tests and preclinical and clinical trials being conducted by or on behalf of the Company and the Subsidiaries Subsidiary are being conducted in compliance in all material respects with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable Laws (orincluding the applicable requirements of Good Laboratory Practices or Good Clinical Practices and the FDA Act and its implementing regulations, where required under applicable lawincluding 21 CFR Parts 50, to 54, 56, 58 and 812). Neither Seller Party has received any written notices, written correspondence or other written communication from the knowledge FDA, an institutional review board or any Governmental Entity requiring the termination, suspension or material modification of the Company, the Managed Providers) owns, holds, possesses or lawfully uses in the operation of its business all applicable Authorizations, other than Authorizations which (i) are not necessary to continue the operation of the business of such Provider in substantially the same manner as it currently operates and has operated heretoforeany clinical trials conducted by, or (ii) if not ownedon behalf of, heldsuch Seller Party, possessed or lawfully used by the Company or such Subsidiary (or by the applicable Managed Provider), would not, individually or in the aggregate, have a Material Adverse Effect. As used herein, "Authorizations" means all licenses, permits, certificates of need, qualifications, registrations, certifications, provider agreements and other authorizations of any governmental authority which are required under applicable Regulations for a Provider to conduct its business and obtain payment for services and goods provided by it under the Federal Medicare program, the state Medicaid program for each state in which such Provider operates (the "Applicable Medicaid Programs")Seller Party has participated, and any other governmental programs for payment of health care services or goods in which such Provider purports to participatethe Seller Parties have no Knowledge that the FDA, other than any of the foregoing which are not material to the business and operations of the relevant Provider, the Company an institutional review board or any Subsidiary. Except as set forth in Schedule 4.13, all of the Authorizations owned, held, possessed or lawfully used by the Company or its Subsidiaries (or, where required under applicable law, to the knowledge of the Company, the Managed Providers) are valid and in good standing, non-probationary, non-provisional and in full force and effect. Except as set forth in Schedule 4.13, none of the Providers Governmental Entity is subject to any governmental restrictions on its operations (e.g., due to prior survey deficiencies) which adversely affects the conduct of its business, other than restrictions which apply to all providers of the services or goods furnished by considering such Provider in the relevant jurisdiction. Except as set forth in Schedule 4.13, there are no actions or proceedings to revoke, withdraw, terminate or suspend any Authorization, neither the Company nor any of its Subsidiaries has received any notice or other communication threatening any of the foregoing (other than notices and communications which have been withdrawn or otherwise resolved), nor does the Company have any knowledge of any reason why any Authorization is likely not to be renewed by the applicable governmental authority in the ordinary courseaction.