Common use of Healthcare Regulatory Matters Clause in Contracts

Healthcare Regulatory Matters. The Company and each of its Subsidiaries have implemented procedures and programs reasonably designed to assure that each of its managed independent or assisted living facilities are operated in compliance in all material respects with all applicable Laws. For the two (2) years preceding the Effective Date, none of the Company or any of its Subsidiaries nor, to the Knowledge of the Company, any employee of the Company or any of its Subsidiaries (acting in their capacity as such) has given, received, offered to pay or solicited any remuneration from, in cash or kind, directly or indirectly, any past or present resident, physician, other healthcare provider, supplier, contractor or other Person in connection with the operation of the business of the Company in violation of applicable Laws, except in each case as would not individually or in the aggregate reasonably be expected to be material to the Company and its Subsidiaries take as whole. For the two (2) years preceding the Effective Date, none of the Company or any of its Subsidiaries: (i) is or has been a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlements, orders, or similar agreements with or imposed by any Governmental Entity with respect to its managed independent or assisted living facilities, (ii) has been assessed a material civil monetary penalty under Section 1128A of the Social Security Act or any regulations promulgated thereunder or any other fine or penalty by any other Governmental Entity with respect to its managed independent or assisted living facilities, (iii) has been charged with, convicted of or entered a plea of guilty or nolo contendere to any criminal or civil offense relating to the delivery of any item or service or any other violation of Laws or (iv) is or has been debarred, excluded or suspended from participating in any federal health care program, except in each case as would not individually or in the aggregate reasonably be expected to be material to the Company and its Subsidiaries take as whole.

Appears in 2 contracts

Samples: Securities Purchase Agreement (Sonida Senior Living, Inc.), Securities Purchase Agreement (Levinson Sam)

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Healthcare Regulatory Matters. The Company (collectively with its Subsidiaries) (a) has operated and each of currently operates its Subsidiaries have implemented procedures and programs reasonably designed to assure that each of its managed independent or assisted living facilities are operated business in compliance in all material respects with all applicable Laws. For the two (2) years preceding the Effective Date, none provisions of the Company Health Care Laws of the Food and Drug Administration (“FDA”), the Department of Health and Human Services and any comparable foreign or any of its Subsidiaries norother regulatory authority to which they are subject (collectively, the “Applicable Regulatory Authorities”) applicable to the Knowledge ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of any of the Company, any employee of the Company ’s or its Subsidiaries’ product candidates or any of its Subsidiaries product manufactured or distributed by the Company, (acting in their capacity as suchb) has givennot received any FDA Form 483, receivedwritten notice of adverse finding, offered to pay or solicited any remuneration fromwarning letter, in cash or kind, directly or indirectly, any past or present resident, physician, other healthcare provider, supplier, contractor untitled letter or other Person in connection correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting non-compliance with the operation of the (i) any Health Care Laws or (ii) any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”), (c) possesses all Regulatory Authorizations required to conduct its business of the Company in violation of applicable Lawsas currently conducted, except in each case as where the failure to possess the same would not not, individually or in the aggregate reasonably be expected to be material to aggregate, have a Material Adverse Effect, and such Regulatory Authorizations are valid and in full force and effect and the Company and its Subsidiaries take as whole. For is not in violation, in any material respect, of any term of any such Regulatory Authorizations, (d) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the two (2) years preceding the Effective Date, none Applicable Regulatory Authorities or any other third party alleging that any product of the Company is in material violation of any Health Care Laws or Regulatory Authorizations and has no knowledge that the Applicable Regulatory Authorities or any other third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding, (e) has not received written notice that any of its Subsidiaries: the Applicable Regulatory Authorities has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Regulatory Authorizations and has no knowledge that any of the Applicable Regulatory Authorities is considering such action, (if) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Regulatory Authorizations and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission), (g) is or has been not a party to and does not have any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlements, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity Applicable Regulatory Authority and (h) along with respect to its managed independent employees, officers and directors, has not been excluded, suspended or assisted living facilitiesdebarred from participation in any government health care program or human clinical research and, (ii) has been assessed a material civil monetary penalty under Section 1128A of the Social Security Act or any regulations promulgated thereunder or any other fine or penalty by any other Governmental Entity with respect to its managed independent or assisted living facilities, (iii) has been charged with, convicted of or entered a plea of guilty or nolo contendere to any criminal or civil offense relating to the delivery of any item Company’s Knowledge, is not subject to a governmental inquiry, investigation, proceeding or service or any other violation of Laws or (iv) is or has been debarred, excluded or suspended from participating in any federal health care program, except in each case as similar action that would not individually or in the aggregate reasonably be expected to be material to the Company and its Subsidiaries take as wholeresult in debarment, suspension or exclusion.

Appears in 1 contract

Samples: Securities Purchase Agreement (Immatics N.V.)

Healthcare Regulatory Matters. The Company and each of its Subsidiaries have implemented procedures and programs reasonably designed to assure that each of its managed independent or assisted living facilities are operated in compliance in all material respects with all applicable Laws. For the past two (2) years preceding the Effective Dateyears, none of the Company or any of its Subsidiaries nor, to the Knowledge of the Company, any employee of the Company or any of its Subsidiaries (acting in their capacity as such) has given, received, offered to pay or solicited any remuneration from, in cash or kind, directly or indirectly, any past or present resident, physician, other healthcare provider, supplier, contractor or other Person in connection with the operation of the business of the Company in violation of applicable Laws, except in each case as would not individually or in the aggregate reasonably be expected to be material to the Company and its Subsidiaries take as whole. For the past two (2) years preceding the Effective Dateyears, none of the Company or any of its Subsidiaries: (i) is or has been a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlements, orders, or similar agreements with or imposed by any Governmental Entity with respect to its managed independent or assisted living facilities, (ii) has been assessed a material civil monetary penalty under Section 1128A of the Social Security Act or any regulations promulgated thereunder or any other fine or penalty by any other Governmental Entity with respect to its managed independent or assisted living facilities, (iii) has been charged with, convicted of or entered a plea of guilty or nolo contendere to any criminal or civil offense relating to the delivery of any item or service or any other violation of Laws or (iv) is or has been debarred, excluded or suspended from participating in any federal health care program, except in each case as would not individually or in the aggregate reasonably be expected to be material to the Company and its Subsidiaries take as whole.

Appears in 1 contract

Samples: Investment Agreement (Capital Senior Living Corp)

Healthcare Regulatory Matters. The Company and each of its Subsidiaries have implemented procedures and programs reasonably designed to assure that each of its managed independent or assisted living facilities are operated in compliance in all material respects with all applicable Lawslaws. For the two (2) years preceding the Effective Date, none None of the Company or any of its Subsidiaries nor, to the Knowledge knowledge of the Company, any employee of the Company or any of its Subsidiaries (acting in their capacity as such) has given, received, offered to pay or solicited any remuneration from, in cash or kind, directly or indirectly, any past or present resident, physician, other healthcare provider, supplier, contractor or other Person in connection with the operation of the business of the Company in violation of applicable Lawslaws, except in each case as would not individually or in the aggregate reasonably be expected to be material to the Company and its Subsidiaries take as wholeresult in a Material Adverse Effect. For the two (2) years preceding the Effective Date, none None of the Company or any of its Subsidiaries: (i) is or has been a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlements, orders, or similar agreements with or imposed by any Governmental Entity applicable governmental entity with respect to its managed independent or assisted living facilities, (ii) has been assessed a material civil monetary penalty under Section 1128A of the Social Security Act or any regulations promulgated thereunder or any other fine or penalty by any other Governmental Entity applicable governmental entity with respect to its managed independent or assisted living facilities, (iii) has been charged with, convicted of or entered a plea of guilty or nolo contendere to any criminal or civil offense relating to the delivery of any item or service or any other violation of Laws applicable laws or (iv) is or has been debarred, excluded or suspended from participating in any federal health care program, except in each case as would not individually or in the aggregate reasonably be expected to be material to the Company and its Subsidiaries take as wholeresult in a Material Adverse Effect.

Appears in 1 contract

Samples: Sales Agreement (Sonida Senior Living, Inc.)

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Healthcare Regulatory Matters. The Company and each of its Subsidiaries have implemented procedures and programs reasonably designed to assure that each of its managed independent or assisted living facilities are operated in compliance in all material respects with all applicable Laws. For the two (2) years preceding the Effective Initial Signing Date, none of the Company or any of its Subsidiaries nor, to the Knowledge of the Company, any employee of the Company or any of its Subsidiaries (acting in their capacity as such) has given, received, offered to pay or solicited any remuneration from, in cash or kind, directly or indirectly, any past or present resident, physician, other healthcare provider, supplier, contractor or other Person in connection with the operation of the business of the Company in violation of applicable Laws, except in each case as would not individually or in the aggregate reasonably be expected to be material to the Company and its Subsidiaries take as whole. For the two (2) years preceding the Effective Initial Signing Date, none of the Company or any of its Subsidiaries: (i) is or has been a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlements, orders, or similar agreements with or imposed by any Governmental Entity with respect to its managed independent or assisted living facilities, (ii) has been assessed a material civil monetary penalty under Section 1128A of the Social Security Act or any regulations promulgated thereunder or any other fine or penalty by any other Governmental Entity with respect to its managed independent or assisted living facilities, (iii) has been charged with, convicted of or entered a plea of guilty or nolo contendere to any criminal or civil offense relating to the delivery of any item or service or any other violation of Laws or (iv) is or has been debarred, excluded or suspended from participating in any federal health care program, except in each case as would not individually or in the aggregate reasonably be expected to be material to the Company and its Subsidiaries take as whole.

Appears in 1 contract

Samples: Investment Agreement (Capital Senior Living Corp)

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