Healthcare Matters. (a) The Company and its Subsidiaries are, and have been since December 31, 2018, in material compliance with applicable Healthcare Laws. Since December 31, 2018, there is and has been no Actions by or before any Governmental Entity pending or to the Knowledge of the Company, threatened by any other Person against the Company or its Subsidiaries with respect to any alleged violation of, or non-compliance with, any Healthcare Laws.
(b) Neither the Company nor its Subsidiaries nor any of their respective owners, directors, officers, managers, managing employees (as such term is defined in 42 U.S.C. § 1320a-5(b)), other personnel (whether employees or independent contractors), vendors, representatives, subcontractors, or agents has been, or is currently: (i) suspended, excluded or debarred from any Governmental Health Program or, threatened with or currently subject to an investigation or proceeding that could result in suspension, exclusion or debarment from any Governmental Health Program; (ii) subject to a civil monetary penalty or civil investigative demand, sanctioned or convicted of a crime, or pled nolo contendere or to sufficient facts, in connection with any allegation of violation of any Governmental Health Program requirement or Healthcare Law; (iii) listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; or (iv) party to any corporate integrity agreement or subjected to reporting obligations pursuant to any deferred prosecution agreement, consent decree, settlement, integrity agreement, corrective action plan or other similar obligation, Order, or agreement with any Governmental Entity.
(c) Neither the Company nor any of its Subsidiaries has engaged in an activity that involves the coding of medical claims, the submission of medical claims, the receipt or sharing of professional medical collections, or clinical decision support.
(d) Since December 31, 2018, neither the Company nor any of its Subsidiaries has been, and presently is not, subject to HIPAA as a “covered entity” or “business associate” (each as defined in HIPAA), and neither the Company, any of its Subsidiaries, nor to the Knowledge of the Company, any of their directors, officers, employees or independent contractors acting on behalf of the Company or any of its Subsidiaries, has ever used, disclosed, created, received, maintained, accessed, or transmitted “protected health information” (as defined...
Healthcare Matters. Except where the failure to comply with any applicable Health Care Law could not reasonably be expected to have a Material Adverse Effect, Parent and each of its Subsidiaries is, and at all times since the Closing Date has been, in compliance with all Health Care Laws applicable to it, its assets, business or operations. No circumstance exists or event has occurred with respect to a violation of any Health Care Law that could reasonably be expected to have a Material Adverse Effect. Neither Parent nor any Subsidiary thereof has received any notice of communication from any Governmental Authority alleging noncompliance with any applicable Health Care Law that could reasonably be expected to have a Material Adverse Effect. For the avoidance of doubt, no notice or any information provided by any Governmental Authority pursuant to this Section 7.01(cc) shall need to be provided to the Administrative Agent or any of the Lenders if such action would be prohibited by Applicable Law.
Healthcare Matters. (a) Except in each case as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect: (i) each Loan Party has all Permits from the FDA or other Governmental Authority, and each such Permit is valid and subsisting in full force and effect; (ii) to the knowledge of Borrower, (x) all applications, notifications, submissions and reports provided by Borrower with respect to such Permits, including any such Permits required in connection with a Specified Product were true, complete, and correct in as of the date of submission to FDA or other Governmental Authority, or were corrected by subsequent submission and (y) all Health Care Activities related to the Specified Products are, and since May 1, 2020 (or, in the case, of Apraglutide, the closing dating of the Designated Acquistion), have been in compliance with all applicable Health Care Laws; (iii) since May 1, 2020 (or, in the case, of Apraglutide, the closing dating of the Designated Acquistion) there have been no recalls, field alerts, “dear doctor” letters, investigator notices, safety alerts or other notices of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Specified Products; and (iv) since May 1, 2020 (or, in the case, of Apraglutide, the closing dating of the Designated Acquistion), the Borrower has not received any written notices from the FDA or other Governmental Authority or from any institutional review board or ethics committee or comparable authority requesting or requiring the termination, suspension, or clinical hold of any ongoing or proposed clinical studies with respect to the Specified Products.
(b) Since May 1, 2020 (or, in the case, of Apraglutide, the closing dating of the Designated Acquistion) neither the Borrower nor, to its knowledge, any of its Affiliates, has been debarred, suspended or excluded, or has been convicted of any crime that would reasonably be expected to result in a debarment, suspension or exclusion by FDA or from any federal or state government health care program.
(c) Since May 1, 2020 (or, in the case, of Apraglutide, the closing dating of the Designated Acquistion), no Loan Party has received written notice that the FDA or any other Governmental Authority is threatening the limitation, suspension or revocation of any Permits required under any applicable Health Care Law or changing the labeling of any Specified Products under such Permits, where such limitation, suspension, revoc...
Healthcare Matters. Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect:
(a) no written notice, notification, demand, request for information, citation, summons, complaint or order has been issued, no complaint has been filed, no penalty has been assessed and no investigation, review or proceeding is pending, or to any Loan Party’s knowledge, threatened to, against or affecting any Loan Party by or before any Governmental Authority or other Person with respect to any (i) alleged violation by any Loan Party of any Healthcare Law; or (ii) alleged failure by any Loan Party to have any Healthcare Permits required in connection with the conduct of its business or to comply with the terms and conditions thereof, except in the case of clauses (i) and (ii), arising as a result of the commencement of the Chapter 11 Cases and except as otherwise stayed by Section 362 of the Bankruptcy Code;
(b) the Borrower and its Subsidiaries have: (i) obtained and currently have all Healthcare Permits necessary to conduct their operations in the ordinary course of business; and (ii) maintained in all material respects all records required to be maintained under Healthcare Laws;
(c) the Borrower and its Subsidiaries have obtained from or have timely filed with (i) the Medicare program, approval to receive the provider numbers which will permit Borrower and its applicable Subsidiaries to bill the Medicare program with respect to covered services rendered by them to patients insured under the Medicare program, if any, and (ii) the applicable Medicaid programs’ approval to receive the provider numbers which will permit Borrower and its applicable Subsidiaries to bill the Medicaid program with respect to covered services rendered by them to patients insured under the Medicaid programs, if any. To the knowledge of any Loan Party, the Borrower and its Subsidiaries are in material compliance with the conditions of participation in the Medicare, Medicaid and other federal or state healthcare programs to the extent necessary for their material operations in the ordinary course of business;
(d) there is no pending nor to the knowledge of any Loan Party, threatened, proceeding or investigation of Borrower or its Subsidiaries by any Governmental Authority with respect to the Medicare, Medicaid or any federal or state healthcare programs with respect to the operations of Borrower or its Subsidiaries. Without limiting or being limited by any other pr...
Healthcare Matters. Within five (5) Business Days after any Credit Party obtaining knowledge thereof:
(i) notice of any material investigation or audit, or pending or threatened proceedings relating to any violation by any Credit Party, any of their Subsidiaries, or any health care facility to which any Credit Party or any their Subsidiaries provides services, of any Health Care Laws (including, without limitation, any investigation or audit or proceeding involving violation of any of the Medicare and/or Medicaid fraud and abuse provisions);
(ii) copies of any written recommendation from any Governmental Authority or other regulatory body that any Credit Party or any of their Subsidiaries, or any obligor to which any Credit Party or any their Subsidiaries provides services should have its licensure, provider or supplier number, or accreditation suspended, revoked, or limited in any way, or have its eligibility to participate in TRICARE, Medicare or Medicaid or to accept assignments or rights to reimbursement under TRICARE, Medicaid or Medicare regulations suspended, revoked, or limited in any way;
(iii) notice of any claim to recover any alleged material overpayments with respect to any receivables including, without limitation, payments received from TRICARE, Medicare, Medicaid or from any private insurance carrier;
(iv) notice of termination of eligibility of any Credit Party, any Subsidiary of any Credit Party, or any health care facility to which any Credit Party provides services to participate in any reimbursement program of any private insurance carrier, managed care or similar organization, or other obligor applicable to it;
(v) notice of any material reduction in the level of reimbursement expected to be received with respect to any Receivables;
(vi) notice of any reimbursement payment contract or process that results or is reasonably expected to result in any claim against a Credit Party or any Subsidiary of such Credit Party (including on account of overpayments, settlement payments, appeals, repayment plan requests);
(vii) copies of any report or communication from any Governmental Authority in connection with any inspection of any facility of a Credit Party or any Subsidiary of such Credit Party other than those which are routine and non-material; and
(viii) notice of any healthcare provider's fees being contested or disputed.
Healthcare Matters. Within five (5) Business Days, notify Agent in writing upon the occurrence of: (i) a voluntary disclosure by any Borrower or any Subsidiary of any Borrower to the Office of the Inspector General of the United States Department of Health and Human Services, any Government Reimbursement Program (including to any intermediary, carrier or contractor of such program), of an actual or potential overpayment matter involving the submission of claims to a Government Reimbursement Program in an amount greater than $1,000,000; (ii) any Borrower or any Subsidiary of any Borrower, an owner, officer, manager, employee or Person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. §420.201) in any Borrower or any Subsidiary of any Borrower: (a) has had a civil monetary penalty assessed against him or her pursuant to 42 U.S.C. §1320a-7a or is the subject of a proceeding seeking to assess such penalty; (b) has been excluded from participation in a Federal Health Care Program (as that term is defined in 42 U.S.C. §1320a-7b) or is the subject of a proceeding seeking to assess such penalty; (c) has been convicted (as that term is defined in 42 C.F.R. §1001.2) of any of those offenses described in 42 U.S.C. §1320a-7b or 18 U.S.C. §§669, 1035, 1347, 1518 or is the subject of a proceeding seeking to assess such penalty; or (d) has been involved or named in a U.S. Attorney complaint made or any other action taken pursuant to the False Claims Act under 31 U.S.C. §§3729-3731 or in any qui tam action brought pursuant to 31 U.S.C. §3729 et seq.; (iii) receipt by any Borrower or any Subsidiary of any Borrower of any written notice or communication from an accrediting organization that such Person is in danger of losing its accreditation due to a failure to comply with a plan of correction; (iv) any validation review, program integrity review or material reimbursement audits related to any Borrower or any Subsidiary of any Borrower in connection with any Third Party Payor reimbursement program; (v) any claim to recover any alleged overpayments with respect to any Receivables, or any notice of any fees of any Borrower or any Subsidiary of any Borrower being contested or disputed, in each case, in excess of $1,000,000; (vi) notice of any material reduction in the level of reimbursement expected to be received with respect to Receivables; (vii) any allegations of material licensure violations or fraudulent acts or omissions involving any Borrower or any S...
Healthcare Matters. The Borrower will, and will cause each of its Subsidiaries to (and, to the extent permitted by applicable law, cause the Associated Practices to), (i) comply in all material respects with all applicable Healthcare Laws relating to the operation of its business, (ii) obtain, maintain and timely renew all material Healthcare Permits required in the proper conduct of its business, (iii) keep and maintain all records required to be maintained by any Governmental Authority or under any Healthcare Law, and (iv) maintain a corporate and health care regulatory compliance program that addresses the requirements of Healthcare Laws, except where the failure to comply, obtain, keep and maintain could not reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect.
Healthcare Matters. Each Healthcare Borrower will not permit to occur any of the following:
(a) any transfer of a Healthcare Authorization or rights thereunder to any Person (other than any Borrower);
(b) any pledge or hypothecation of any Healthcare Authorization as collateral security for any Indebtedness other than Indebtedness to Agent;
(c) any rescission, withdrawal or revocation of any material Healthcare Authorization necessary for the conduct of such Xxxxxxxx’s business without Agent’s prior written consent (which consent shall not be unreasonably withheld, delayed or conditioned), including, without limitation, any amendment or modification of such Healthcare Authorization.
Healthcare Matters. (a) Without limiting or qualifying Section 5.4, or any other provision of this Agreement, the REIT Guarantor and the Borrower will, and will cause their respective Subsidiaries to, be in compliance with all applicable Health Care Laws relating to the operation of such Person’s business, except where the failure to do so, either individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect.
(b) Except where the failure to do so or noncompliance could not reasonably be expected to result in a Material Adverse Effect, the REIT Guarantor and the Borrower will, and will cause each of their respective Subsidiaries to:
(i) obtain, maintain and preserve, and take all necessary action to timely renew, all Health Care Permits (including, as applicable, Health Care Permits necessary for it to be eligible to receive payment and compensation from and to participate in Medicare, Medicaid or any other third party payors), if any, which are necessary or useful for any Loan Party or Subsidiary thereof to obtain or maintain in the proper conduct of its business;
(ii) solely to the extent applicable to the Loan Parties and their Subsidiaries, be and remain in compliance with all requirements for participation in, and for licensure required to provide the goods or services that are reimbursable under, Medicare, Medicaid and other third party payor programs;
(iii) cause all licensed personnel of the Loan Parties, if any, to be in compliance with all applicable Health Care Laws in the performance of their duties to or for the Loan Parties, and to maintain in full force and effect all professional licenses and other Health Care Permits required to perform such duties; and
(iv) keep and maintain all records required to be maintained by any Governmental Authority or otherwise under any Health Care Law applicable to the Loan Parties.
Healthcare Matters. Without limiting the generality of any other covenant contained in this Agreement, and except as would not reasonably be expected to have a Material Adverse Effect, the Borrower will, and will cause each of its Subsidiaries to (i) conduct its operations in compliance with all applicable Healthcare Laws, (ii) maintain and comply with all Governmental Payor Arrangements, Third Party Payor Arrangements, Licenses, Company Accreditations and Company Reimbursement Approvals, (iii) timely file, or cause to be filed, all Company Regulatory Filings in accordance with all Requirements of Law, (iv) timely pay all amounts, Taxes, fees and assessments, if any, due and payable in connection with Company Regulatory Filings, (v) timely submit and implement all corrective action plans required to be prepared and submitted in response to any Health Care Audits, (vi) timely refund all overpayments (other than those appealed through the ordinary administrative processes of any applicable Governmental Authority) determined to exist by any Governmental Authority under any Healthcare Law or pursuant to any Governmental Payor Arrangement, (vii) timely repay any overpayment amounts owing under any finally resolved audit or investigation by any Third Party Payor, and (viii) process credit balances received from Third Party Payors in a manner consistent with the Borrower’s internal policies. The Borrower will, and will cause each of its Subsidiaries to, notify the Administrative Agent promptly after the Borrower or any of its Subsidiaries becomes aware of any violation of Healthcare Laws by the Borrower or any of its Subsidiaries that would reasonably be expected to have a Material Adverse Effect.