Common use of Healthcare Matters Clause in Contracts

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, revocation, or change would reasonably be expected to have a Material Adverse Effect.

Healthcare Matters. Without limiting the generality of Section 5.10 or Section 5.19: (a) Except in each case as would notSince January 1, individually or in 2019, the aggregate, reasonably be expected to have a Material Adverse Effect: (i) each Loan Party has all Permits from the FDA or other Governmental AuthorityCompany is, and each such Permit is valid at all times has been, in compliance in all material respects with all applicable Healthcare Laws. (b) There are no, and subsisting in full force and effect; (ii) since January 1, 2019, there have not been any Actions pending or, to the knowledge of Borrowerthe Company, threatened against the Company alleging a violation of Healthcare Law. (xc) all applicationsNeither the Company nor any of its directors, notificationsmanaging employees or executive officers, submissions and reports provided by Borrower is currently, or has ever been suspended, excluded or debarred from any Government Program or threatened with respect or currently subject to such Permitsan investigation or proceeding that could result in suspension, including exclusion or debarment from any such Permits required Government Program or any other debarment, exclusion or sanction list or database, in connection with a Specified Product were true, complete, and correct in each case that remains unresolved as of the date of submission this Agreement. (d) Since January 1, 2019, to FDA the Company’s knowledge, the Company has not made an untrue statement of fact or other fraudulent statement to any Governmental Authority, failed to disclose a fact required to be disclosed to any Governmental Authority, or were corrected committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would be in violation of any Healthcare Law. The Company does not bxxx nor is the Company reimbursed by subsequent submission and any Payor. (ye) all Health Care Activities related The Company (i) is not a party to a corporate Integrity Agreement with the Specified Products are, and since May 1, 2020 (or, in the case, Office of Apraglutide, the closing dating Inspector General of the Designated Acquistion)Department of Health and Human Services, (ii) does not have been in compliance any reporting obligation pursuant to any settlement agreement entered into with all applicable Health Care Laws; any governmental entity, (iii) since May 1is not the subject of any Government Program investigation conducted by any federal or state enforcement agency, 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 1is not a defendant in any qui tam/False Claims Act litigation, 2020 and (or, in the case, of Apraglutide, the closing dating of the Designated Acquistion), the Borrower v) has not been served with or 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 terminationsearch warrant, suspensionsubpoena, civil investigative demand, contact letter, or clinical hold of any ongoing personal 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 telephone contact by FDA or from any federal or state government health care programenforcement agency, in each case other than routine contacts and notifications not relating to an investigation or an actual or potential violation of Law, in each case (i) though (v) which remains unresolved. (cf) Since May January 1, 2020 2019, (ori) the Company has been in compliance in all material respects with HIPAA and has had privacy and security policies, in notices, procedures and safeguards that materially comply with HIPAA; (ii) the case, of Apraglutide, the closing dating of the Designated Acquistion), no Loan Party Company has not received written notice of, and there is no Action at law or in equity or, inquiry or investigation pending or threatened with respect to any alleged “breach” as defined in 45 C.F.R. § 164.402 (a “Breach”) by the Company or its “workforce” (as defined in 45 C.F.R. § 160.103); (iii) no Breach by the Company or its “workforce” or successful “security incident” (as defined in 45 C.F.R. § 164.304) has occurred with respect to “protected health information” or “PHI” (as defined in 45 C.F.R. § 160.103) in the possession or under the control of the Company or any business associate of the Company; and (iv) the Company has undertaken all surveys, audits, inventories, reviews, analyses and/or assessments (including any necessary risk assessments) of all areas of the business of the Company required by HIPAA and have implemented appropriate corrective action to address all material vulnerabilities in their HIPAA safeguards and controls identified through such necessary assessments. The Company has entered into written, signed, and HIPAA-compliant business associate agreements with each Person who is a “covered entity” or “business associate” (each as defined in 45 C.F.R. § 160.103) of the Company. The Company does not undertake the de-identification of “protected health information” or “PHI” as defined under HIPAA. To the extent that the FDA Company aggregates the PHI of its clients, the Company has obtained all rights necessary to aggregate such PHI, except as would not be material to the Company. (g) All products or services marketed by or on behalf of the Company that are subject to the jurisdiction of Healthcare Laws are marketed in compliance in all material respects, with all applicable Healthcare Laws. (h) None of the Company’s employees nor any other Governmental Authority independent contractor of the Company 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, revocation, or change would reasonably be expected to have a Material Adverse EffectLicensed Personnel.

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 AuthorityThe Company and its Subsidiaries are, and each such Permit have been since December 31, 2018, in material compliance with applicable Healthcare Laws. Since December 31, 2018, there is valid and subsisting in full force and effect; (ii) has been no Actions by or before any Governmental Entity pending or to the knowledge Knowledge of Borrowerthe Company, (x) all applications, notifications, submissions and reports provided threatened by Borrower any other Person against the Company or its Subsidiaries 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 Authorityalleged violation of, or were corrected by subsequent submission and (y) all Health Care Activities related to the Specified Products arenon-compliance with, 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 any Healthcare 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 1Neither the Company nor its Subsidiaries nor any of their respective owners, 2020 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 the casesuspension, exclusion or debarment from any Governmental Health Program; (ii) subject to a civil monetary penalty or civil investigative demand, sanctioned or convicted 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 excludeda crime, or has been convicted pled nolo contendere or to sufficient facts, in connection with any allegation of violation of any crime that would reasonably be expected 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 result in a debarmentany corporate integrity agreement or subjected to reporting obligations pursuant to any deferred prosecution agreement, suspension consent decree, settlement, integrity agreement, corrective action plan or exclusion by FDA other similar obligation, Order, or from agreement with any federal or state government health care programGovernmental Entity. (c) Since May 1, 2020 (or, Neither the Company nor any of its Subsidiaries has engaged in an activity that involves the case, coding of Apraglutidemedical claims, the closing dating 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 Designated Acquistion)Company, no Loan Party has received written notice that any of their directors, officers, employees or independent contractors acting on behalf of the FDA Company or any other Governmental Authority is threatening the limitationof its Subsidiaries, suspension or revocation of any Permits required under any applicable Health Care Law or changing the labeling of any Specified Products under such Permitshas ever used, where such limitationdisclosed, suspensioncreated, revocationreceived, maintained, accessed, or change would reasonably be expected transmitted “protected health information” (as defined in HIPAA) to have a Material Adverse Effectconduct its business, except for incidental receipt or viewing of PHI in which no PHI was retained by the Company or any of its Subsidiaries.

Healthcare Matters. (a) Except as disclosed in the Commission Documents, since the Business Combination Closing Date, the Company and each of its Subsidiaries are, and at all times have been, in compliance with all applicable Healthcare Laws, except where the failure to be in compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. Except as disclosed in the Commission Documents, there are no, and since the Business Combination Closing Date, there have not been any Actions pending or, to the Knowledge of the Company, threatened against the Company or any of its Subsidiaries alleging a violation of Healthcare Law. Except as disclosed in the Commission Documents, none of the Company, any of its Subsidiaries or any of their respective directors, managing employees or executive officers, is currently, or has ever been suspended, excluded or debarred from any Government Program or threatened with or currently subject to an investigation or proceeding that could result in suspension, exclusion or debarment from any Government Program or any other debarment, exclusion or sanction list or database, in each case that remains unresolved as of the Closing Date. Since the Business Combination Closing Date, to the Company’s Knowledge, neither the Company nor any of its Subsidiaries has made an untrue statement of fact or fraudulent statement to any Governmental Authority, failed to disclose a fact required to be disclosed to any Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would be in material violation of any Healthcare Law. Except as disclosed in the Commission Documents, neither the Company nor any of its Subsidiaries (i) is a party to a corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services, (ii) has any reporting obligation pursuant to any settlement agreement entered into with any Governmental Authority, (iii) is the subject of any Government Program investigation conducted by any federal or state enforcement agency, (iv) is a defendant in any qui tam/False Claims Act litigation, or (v) has been served with or received any search warrant, subpoena, civil investigative demand, contact letter, or personal or telephone contact by or from any federal or state enforcement agency, in each case other than routine contacts and notifications not relating to an investigation or an actual or potential violation of Law, or in any case as would, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. Except as disclosed in the Commission Documents or as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect: , since the Business Combination Closing Date, (i) each Loan Party of the Company and its Subsidiaries has been in compliance in all Permits from the FDA or other Governmental Authoritymaterial respects with HIPAA and has had privacy and security policies, notices, procedures and each such Permit is valid and subsisting in full force and effectsafeguards that materially comply with HIPAA; (ii) to neither the knowledge Company nor any of Borrowerits Subsidiaries has received written notice of, (x) all applicationsand there is no Action at law or in equity or, notifications, submissions and reports provided by Borrower inquiry or investigation pending or threatened with respect to such Permitsany alleged “breach” as defined in 45 C.F.R. § 164.402 (a “Breach”) by the Company, any of its Subsidiaries or their “workforce” (as defined in 45 C.F.R. § 160.103); (iii) no Breach by the Company, any of its Subsidiaries or their “workforce” or successful “security incident” (as defined in 45 C.F.R. § 164.304) has occurred with respect to “protected health information” or “PHI” (as defined in 45 C.F.R. § 160.103) in the possession or under the control of the Company, any of its Subsidiaries or any of their business associates; and (iv) the Company and its Subsidiaries have undertaken all surveys, audits, inventories, reviews, analyses and/or assessments (including any such Permits required in connection with a Specified Product were true, complete, and correct in as necessary risk assessments) of all areas of the date business of submission the Company and its Subsidiaries required by HIPAA and have implemented appropriate corrective action to FDA address all material vulnerabilities in their HIPAA safeguards and controls identified through such necessary assessments. Except as set forth in the Commission Documents, all products or other Governmental Authority, services marketed by or were corrected by subsequent submission on behalf of the Company and (y) all Health Care Activities related its Subsidiaries that are subject to the Specified Products are, and since May 1, 2020 (or, in the case, jurisdiction of Apraglutide, the closing dating of the Designated Acquistion), have been Healthcare Laws are marketed in compliance with all applicable Health Care Healthcare Laws; (iii) since May 1, 2020 (orexcept where the failure to be in compliance would not, individually or in the caseaggregate, 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, revocation, or change would reasonably be expected to have a Material Adverse Effect.

Healthcare Matters. (a) Except The Company and its Subsidiaries are, and at all times since January 1, 2018, have been, in each case as compliance in all material respects with all applicable Healthcare Laws, except for such non-compliance which would not, individually or in the aggregate, reasonably be expected to have not constitute 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 1Without limiting the generality of Section 5.24(a), 2020 (there is no Action, or proceeding pending or, in to the case, of Apraglutide, the closing dating knowledge of the Designated Acquistion) neither Company, threatened in writing against the Borrower nor, to its knowledge, any Company alleging a violation of its Affiliates, has been debarred, suspended or excluded, or has been convicted of any crime Healthcare Laws that would reasonably be expected to result in any current or prospective exclusion from any Government Program or that would constitute a debarmentMaterial Adverse Effect. (c) Neither the Company nor its Subsidiaries, suspension or exclusion to the knowledge of the Company, any director, manager or executive officer of the Company or its Subsidiaries, (i) has been assessed a civil monetary penalty under Section 1128A of the Social Security Act, (ii) has been excluded from participation in any Government Program, or (iii) has been convicted of a felony relating to the delivery of any item or service under a Government Program. (d) Neither the Company nor any of its Subsidiaries (i) is a party to a Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services, (ii) has any reporting obligation pursuant to any settlement agreement entered into with any Governmental Authority, (iii) is, to the knowledge of the Company, the subject of any Government Program investigation conducted by FDA any federal or state enforcement agency, (iv) is, to the knowledge of the Company, a defendant in any qui tam/False Claims Act litigation, or (v) has been served with or received any search warrant, subpoena, civil investigative demand, contact letter, or personal or telephone contact by or from any federal or state government health care programenforcement agency, in each case other than routine contacts and notifications not relating to an investigation or an actual or potential violation of law, in each case (i) though (v) which remains unresolved as of the date hereof. (ce) Since May January 1, 2020 2018 and through and including the date of this Agreement, each of the Company and its Subsidiaries are in compliance in all material respects with HIPAA and to the knowledge of the Company, no “security incident” or “breach” has occurred with respect to “protected health information,” (oras such terms are defined under HIPAA), in the case, possession or under the control of Apraglutidethe Company that would require the Company to provide notice. As of the date hereof, the closing dating Company and its Subsidiaries have entered into appropriate contractual arrangements with their customers and subcontractors as required by HIPAA and have implemented appropriate policies and procedures to ensure compliance with HIPAA and the protection of protected health information. Since January 1, 2018, neither the Designated Acquistion), no Loan Party Company nor its Subsidiaries has received any written notice that inquiry from the FDA United States Department of Health and Human Services or any other Governmental Authority is threatening alleging material violations of HIPAA by the limitationCompany, 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, revocationits Subsidiaries, or change would reasonably be expected any of their subcontractors. Since January 1, 2018, to have a Material Adverse Effectthe Company’s knowledge, no complaint has been filed with the United States Department of Health and Human Services or any other Governmental Authority regarding material non-compliance with HIPAA by the Company, its Subsidiaries, or any of their subcontractors.

Healthcare Matters. (a) Except as disclosed in the Commission Documents, since October 28, 2022, the Company and each of its Subsidiaries are, and at all times have been, in compliance with all applicable Healthcare Laws, except where the failure to be in compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. Except as disclosed in the Commission Documents, there are no, and since October 28, 2022, there have not been any Actions pending or, to the Knowledge of the Company, threatened against the Company or any of its Subsidiaries alleging a violation of Healthcare Law. Except as disclosed in the Commission Documents, none of the Company, any of its Subsidiaries or any of their respective directors, managing employees or executive officers, is currently, or has ever been suspended, excluded or debarred from any Government Program or threatened with or currently subject to an investigation or proceeding that could result in suspension, exclusion or debarment from any Government Program or any other debarment, exclusion or sanction list or database, in each case that remains unresolved as of the applicable Closing Date. Since October 28, 2022, to the Company’s Knowledge, neither the Company nor any of its Subsidiaries has made an untrue statement of fact or fraudulent statement to any Governmental Authority, failed to disclose a fact required to be disclosed to any Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would be in material violation of any Healthcare Law. Except as disclosed in the Commission Documents, neither the Company nor any of its Subsidiaries (i) is a party to a corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services, (ii) has any reporting obligation pursuant to any settlement agreement entered into with any Governmental Authority, (iii) is the subject of any Government Program investigation conducted by any federal or state enforcement agency, (iv) is a defendant in any qui tam/False Claims Act litigation, or (v) has been served with or received any search warrant, subpoena, civil investigative demand, contact letter, or personal or telephone contact by or from any federal or state enforcement agency, in each case other than routine contacts and notifications not relating to an investigation or an actual or potential violation of Law, or in any case as would, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. Except as disclosed in the Commission Documents or as would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect: , since October 28, 2022, (i) each Loan Party of the Company and its Subsidiaries has been in compliance in all Permits from the FDA or other Governmental Authoritymaterial respects with HIPAA and has had privacy and security policies, notices, procedures and each such Permit is valid and subsisting in full force and effectsafeguards that materially comply with HIPAA; (ii) to neither the knowledge Company nor any of Borrowerits Subsidiaries has received written notice of, (x) all applicationsand there is no Action at law or in equity or, notifications, submissions and reports provided by Borrower inquiry or investigation pending or threatened with respect to such Permitsany alleged “breach” as defined in 45 C.F.R. § 164.402 (a “Breach”) by the Company, any of its Subsidiaries or their “workforce” (as defined in 45 C.F.R. § 160.103); (iii) no Breach by the Company, any of its Subsidiaries or their “workforce” or successful “security incident” (as defined in 45 C.F.R. § 164.304) has occurred with respect to “protected health information” or “PHI” (as defined in 45 C.F.R. § 160.103) in the possession or under the control of the Company, any of its Subsidiaries or any of their business associates; and (iv) the Company and its Subsidiaries have undertaken all surveys, audits, inventories, reviews, analyses and/or assessments (including any such Permits required in connection with a Specified Product were true, complete, and correct in as necessary risk assessments) of all areas of the date business of submission the Company and its Subsidiaries required by HIPAA and have implemented appropriate corrective action to FDA address all material vulnerabilities in their HIPAA safeguards and controls identified through such necessary assessments. Except as set forth in the Commission Documents, all products or other Governmental Authority, services marketed by or were corrected by subsequent submission on behalf of the Company and (y) all Health Care Activities related its Subsidiaries that are subject to the Specified Products are, and since May 1, 2020 (or, in the case, jurisdiction of Apraglutide, the closing dating of the Designated Acquistion), have been Healthcare Laws are marketed in compliance with all applicable Health Care Healthcare Laws; (iii) since May 1, 2020 (orexcept where the failure to be in compliance would not, individually or in the caseaggregate, 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, revocation, or change would reasonably be expected to have a Material Adverse Effect.