Common use of Healthcare Compliance Matters Clause in Contracts

Healthcare Compliance Matters. (i) Holdings and each of its Subsidiaries are in compliance with and since January 1, 2013 have not violated any Health Care Law applicable to Holdings or any of its Subsidiaries or any items or services provided by or assets owned or used by any of them (except for such past noncompliance as has been remedied and imposes no continuing obligations or costs on Holdings or its Subsidiaries), and (ii) neither Holdings nor any of its Subsidiaries has received any written communication since January 1, 2013 from a Governmental Entity alleging that Holdings or any of its Subsidiaries is or was not, or may not be, in compliance with any Health Care Law, except in the case of clauses (i) and (ii) where any actual or alleged non-compliance, individually or in the aggregate, has not had and would not reasonably be expected to have, a Holdings Material Adverse Effect. Neither Holdings nor, to the Knowledge of Holdings, any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity. Additionally, none of Holdings, its Subsidiaries or any of its respective employees, officers or directors or any Holdings Healthcare Professional has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or, to the Knowledge of Holdings, has been convicted of any crime or is subject to a governmental inquiry, investigation, Proceeding, or other similar action, or has engaged in any conduct, that could reasonably be expected to result in debarment, suspension, or exclusion. (b) Except as would not have, individually or in the aggregate, a Holdings Material Adverse Effect, neither Holdings nor its current or former Subsidiaries nor, to the Knowledge of Holdings, any of the owners, managers, officers, directors, employees or contractors of Holdings or any of its Subsidiaries or any Holdings Healthcare Professional have been since January 1, 2013 through the date hereof: (i) convicted of, charged with or, to the Knowledge of Holdings, investigated by a Governmental Entity for any violation of any Laws or other misconduct related to any Governmental Program, (ii) convicted of, charged with or, to the Knowledge of Holdings, investigated by a Governmental Entity for a violation of any Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances related to the business or operations of Holdings or any of its Subsidiaries, (iii) excluded, suspended or debarred from, or otherwise ineligible to participate in, any Governmental Program, nor, to the Knowledge of Holdings, is any such exclusion, suspension or bar pending or threatened, or (iv) subject to any Order with respect to the business or operations of Holdings or any of its Subsidiaries. (c) To the Knowledge of Holdings and except where such noncompliance, individually or in the aggregate, has not had and would not reasonably be expected to have, a Holdings Material Adverse Effect, each of the Persons performing clinical or professional healthcare services, including without limitation all physicians, mid-level providers (e.g., nurse practitioners, physician assistants, certified-registered nurse anesthetists), nurses paramedics, emergency medical technicians, or any other clinical staff on behalf of Holdings or its Subsidiaries, whether as an employee or independent contractor (each, a “Holdings Healthcare Professional” and collectively, the “Holdings Healthcare Professionals”): (i) has maintained and currently holds, in good standing, all Permits required by any applicable Law or Governmental Entity to perform the services in the states that such Holdings Healthcare Professional is practicing or performing professional services on behalf of Holdings or any of its Subsidiaries; and (ii) to the extent required, has been granted and continues to hold requisite staff privileges at, and is currently, and since January 1, 2013 has been, in good standing with, each of the hospitals and other healthcare facilities at or for which such Holdings Healthcare Professional performs medical services on behalf of Holdings or its Subsidiaries. To the Knowledge of Holdings, each Holdings Healthcare Professional has been and is in compliance with the terms and conditions of such Permits, except where such noncompliance would not, individually or in the aggregate, have a Holdings Material Adverse Effect. To the Knowledge of Holdings, as of the date hereof, neither Holdings nor any of its Subsidiaries has received written notice that any Holdings Healthcare Professional is under investigation by, the subject of a self-disclosure to, or is not in good standing with, any Governmental Program or Governmental Entity, except where an unfavorable decision, ruling or finding of any such investigation or disclosure would not, individually or in the aggregate, have a Holdings Material Adverse Effect. With respect to Holdings Healthcare Professionals engaged on an independent contractor basis, Holdings or its Subsidiary has insured and insures, and maintains a certificate of insurance from each Holdings Healthcare Professional evidencing, that such Holdings Healthcare Professionals have in place malpractice insurance, except where such failure to maintain such insurance would not, individually or in the aggregate, have a Holdings Material Adverse Effect. (d) Except as would not have, individually or in the aggregate, a Holdings Material Adverse Effect, (i) Holdings and its Subsidiaries are each qualified for participation with, or currently participates with, all Governmental Programs and Private Programs from which such entity seeks or receives reimbursement for items or services, (ii) the billing practices of Holdings and its Subsidiaries to all customers, private individuals or patients, Governmental Programs and Private Programs have been and are in material compliance with applicable Health Care Laws, the HCPCS code set, and rules of applicable Governmental Programs, and (iii) neither Holdings nor any of its Subsidiaries has (a) billed, received or failed, whether on its behalf or on behalf of another Person, to timely return any material payment or reimbursement in excess of amounts allowed by applicable Health Care Laws, or (b) any material outstanding overpayments, refunds or Liability due to any Governmental Program or Governmental Entity. Except to the extent qualifying as ordinary course and except as would not have, individually or in the aggregate, a Holdings Material Adverse Effect, there are no pending appeals, adjustments, investigations, inquires, challenges, Actions or notices of intent to audit or investigate by any Governmental Program or Governmental Entity with respect to enrollment eligibility, compliance with conditions of participation or payment, or claims, reports or other submissions by Holdings or any of its Subsidiaries. (e) Neither Holdings, nor any of its Subsidiaries has made since January 1, 2013, or is in the process of making, any voluntary self-disclosure to any Governmental Program or Governmental Entity, including without limitation any voluntary self-disclosures to the Centers for Medicare & Medicaid Services pursuant to the Medicare self-referral disclosure protocol or to the Office of the Inspector General pursuant to its self-disclosure protocol, or to any United States Attorney. To the Knowledge of Holdings, none of Holdings, its Subsidiaries or any of its Holdings Healthcare Professionals are mentioned in any voluntary self-disclosure made to any Governmental Entity by any healthcare facility or any other Person. (f) None of Holdings, its Subsidiaries or, to the Knowledge of Holdings, any Holdings Healthcare Professional is a party to, or bound by, any Order, corporate integrity agreement, deferred prosecution agreement, settlement agreement or other written agreement with any Governmental Entity concerning compliance with Health Care Laws that, individually or in the aggregate, have a Holdings Material Adverse Effect. (g) Holdings and its Subsidiaries have instituted and operate in accordance with a compliance plan which is consistent with guidance of the Office of Inspector General of the United States Department of Health & Human Services. (h) None of Holdings and its Subsidiaries has received notice of and, to the Knowledge of Holdings, there is and has been no individual complaint, pending or threatened litigation, legal proceeding (in law or in equity) or governmental or administrative investigation, settlement or penalty with respect to Holdings or any of its Subsidiaries or their respective Workforces (as defined under HIPAA) uses or disclosures of, or security practices regarding, individually identifiable health information, uses or disclosures of, or security practices regarding, individually identifiable health information, in each case that would be material to Holdings and its Subsidiaries, taken as a whole. To the Knowledge of Holdings, no Breach (as defined at 45 C.F.R. § 164.402) has occurred with respect to any unsecured PHI maintained by or for Holdings or any of its Subsidiaries that is subject to the notification requirements of 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b). To the Knowledge of Holdings, any Security Incidents (as defined at 45 C.F.R. § 164.304) involving unsecured PHI maintained by or for Holdings or any of its Subsidiaries have been Unsuccessful Security Incidents or non-material Security Incidents. None of Holdings and its Subsidiaries has notified the media or any Governmental Authority of any Breach as required by 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b), and none of Holdings and its Subsidiaries is currently planning to conduct any such notification or is investigating whether any such notification to the media or any Governmental Authority is required. Each of Holdings and its Subsidiaries has in place, and has complied and is in compliance with, written policies to protect the security and privacy of PHI. Each of Holdings and its Subsidiaries has the right pursuant to its contracts and its privacy and security policies to use and disclose PHI for the purposes for which such information is and has been used and disclosed. Neither the execution, delivery or performance of this Agreement, nor the consummation of any of the transactions contemplated by this Agreement, including any transfer of PHI resulting from such transactions, will violate any policies of Holdings or its Subsidiaries or any privacy agreements to which Holdings or its Subsidiaries are a party as such policies or privacy agreements currently exist or as existed at any time during which any of such PHI was collected or obtained.

Healthcare Compliance Matters. (a) (i) Holdings Sirona and each of its Subsidiaries are in compliance with and since January 1June 30, 2013 2012 have not violated any been in compliance with all Health Care Law Laws applicable to Holdings Sirona or any of its Subsidiaries or any items or services provided by or assets owned or used by any of them (except for such past noncompliance as has been remedied and imposes no continuing obligations or costs on Holdings Sirona or its Subsidiaries), and (ii) neither Holdings Sirona nor any of its Subsidiaries has received any written communication since January 1June 30, 2013 2012 from a Governmental Entity alleging that Holdings remains uncured or unresolved and that alleges that Sirona or any of its Subsidiaries is or was not, or may not be, in compliance with any Health Care Law, except in the case of clauses (i) and (ii) where any actual or alleged non-compliance, individually or in the aggregate, has not had and would not reasonably be expected to have, a Holdings Sirona Material Adverse Effect. Neither Holdings Sirona nor, to the Knowledge of HoldingsSirona, any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity. Additionally, none of HoldingsSirona, its Subsidiaries or any of its respective employees, officers or directors or any Holdings Healthcare Professional has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or, to the Knowledge of HoldingsSirona, has been convicted of any crime or is subject to a governmental inquiry, investigation, Proceeding, or other similar action, or has engaged in any conduct, that could reasonably be expected to result in debarment, suspension, or exclusion. (b) Except Sirona and each of its Subsidiaries have, maintain and are operating in material compliance with all Permits of the United States Food and Drug Administration (“FDA”) and comparable Governmental Entities which are required for the conduct of their business as currently conducted (collectively, the “FDA Permits”), and all such FDA Permits are valid, subsisting, and in full force and effect, except where the failure to have, maintain or operate in material compliance with the FDA Permits has not had, and would not reasonably be expected to have, individually or in the aggregate, a Holdings Sirona Material Adverse Effect, neither Holdings nor . Sirona and each of its current or former Subsidiaries nor, have fulfilled and performed all of their material obligations with respect to the Knowledge FDA Permits, and no event has occurred which allows, or with notice or lapse of Holdingstime or both, would allow revocation or termination thereof or results in any other material impairment of the rights of the holder of any FDA Permit, except where the failure to so fulfill or perform, or the occurrence of such event, would not result in a Sirona Material Adverse Effect. Sirona and each of its Subsidiaries have operated and currently are in compliance in all material respects with applicable Laws administered or enforced by the FDA and comparable Governmental Entities, except where the failure to so comply would not result in a Sirona Material Adverse Effect. Sirona and each of its Subsidiaries have not received, since June 30, 2012, written notice of any pending or threatened Proceeding (other than FDA audits) from the FDA, any Governmental Entity, any qui-tam relator or applicable foreign Governmental Entity alleging that any operation or activity of the owners, managers, officers, directors, employees or contractors of Holdings Sirona or any of its Subsidiaries or any Holdings Healthcare Professional have been since January 1, 2013 through the date hereof: (i) convicted of, charged with or, to the Knowledge of Holdings, investigated by a Governmental Entity for any is in material violation of any Laws or other misconduct related applicable Health Care Law which violation would reasonably be expected to any Governmental Program, (ii) convicted of, charged with or, to the Knowledge of Holdings, investigated by have a Governmental Entity for a violation of any Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances related to the business or operations of Holdings or any of material and adverse impact on Sirona and its Subsidiaries, (iii) excluded, suspended or debarred from, or otherwise ineligible to participate in, any Governmental Program, nor, to the Knowledge of Holdings, is any such exclusion, suspension or bar pending or threatened, or (iv) subject to any Order with respect to the business or operations of Holdings or any of its Subsidiariestaken as a whole. (c) To the Knowledge of Holdings and except where such noncompliance, individually or in the aggregate, Except as has not had and would not reasonably be expected to have, a Holdings Material Adverse Effect, each of the Persons performing clinical or professional healthcare services, including without limitation all physicians, mid-level providers (e.g., nurse practitioners, physician assistants, certified-registered nurse anesthetists), nurses paramedics, emergency medical technicians, or any other clinical staff on behalf of Holdings or its Subsidiaries, whether as an employee or independent contractor (each, a “Holdings Healthcare Professional” and collectively, the “Holdings Healthcare Professionals”): (i) has maintained and currently holds, in good standing, all Permits required by any applicable Law or Governmental Entity to perform the services in the states that such Holdings Healthcare Professional is practicing or performing professional services on behalf of Holdings or any of its Subsidiaries; and (ii) to the extent required, has been granted and continues to hold requisite staff privileges at, and is currently, and since January 1, 2013 has been, in good standing with, each of the hospitals and other healthcare facilities at or for which such Holdings Healthcare Professional performs medical services on behalf of Holdings or its Subsidiaries. To the Knowledge of Holdings, each Holdings Healthcare Professional has been and is in compliance with the terms and conditions of such Permits, except where such noncompliance would not, individually or in the aggregate, have a Holdings Sirona Material Adverse Effect. To , all applications, notifications, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the Knowledge basis for or submitted in connection with any and all requests for a FDA Permit from the FDA or other Governmental Entity relating to Sirona and each of Holdingsits Subsidiaries, their business and products, when submitted to the FDA or other Governmental Entity were true, complete and correct as of the date hereofof submission and any necessary or required updates, neither Holdings nor any of its Subsidiaries has received written notice that any Holdings Healthcare Professional is under investigation bychanges, corrections or modification to such applications, submissions, information and data have been submitted to the subject of a self-disclosure to, FDA or is not in good standing with, any Governmental Program or other Governmental Entity, except where an unfavorable decision, ruling or finding of any such investigation or disclosure would not, individually or in the aggregate, have a Holdings Material Adverse Effect. With respect to Holdings Healthcare Professionals engaged on an independent contractor basis, Holdings or its Subsidiary has insured and insures, and maintains a certificate of insurance from each Holdings Healthcare Professional evidencing, that such Holdings Healthcare Professionals have in place malpractice insurance, except where such failure to maintain such insurance would not, individually or in the aggregate, have a Holdings Material Adverse Effect. (d) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Holdings Sirona Material Adverse Effect, (i) Holdings since June 30, 2012, Sirona and its Subsidiaries are each qualified for participation with, or currently participates with, all Governmental Programs and Private Programs from which such entity seeks or receives reimbursement for items or services, (ii) the billing practices of Holdings and its Subsidiaries to all customers, private individuals or patients, Governmental Programs and Private Programs have been and are in material compliance with applicable Health Care Laws, the HCPCS code set, and rules of applicable Governmental Programs, and (iii) neither Holdings nor any of its Subsidiaries has have not had any product or manufacturing site (a) billed, received whether owned by Sirona or failed, whether on its behalf or on behalf of another Person, to timely return any material payment or reimbursement in excess of amounts allowed by applicable Health Care LawsSubsidiary(s), or a contract manufacturer for their products) subject to a Governmental Entity (bincluding FDA) shutdown or import or export prohibition, nor received any material outstanding overpaymentsFDA Form 483 or other Governmental Entity notice of inspectional observations, refunds “warning letters,” “untitled letters” or Liability due requests or requirements to make changes to the products, or similar correspondence or notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any Governmental Program applicable Law, Permit or such requests or requirements of a Governmental Entity. . (e) Except to the extent qualifying as ordinary course has not had and except as would not reasonably be expected to have, individually or in the aggregate, a Holdings Sirona Material Adverse Effect, (i) since June 30, 2012, there have been no (A) recalls, field notifications, field corrections, market withdrawals or replacements, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance (“Safety Notices”) with respect to the products of Sirona and its Subsidiaries or (B) to the Knowledge of Sirona, complaints with respect to such products that are currently unresolved and (ii) to the Knowledge of Sirona, there are no pending appeals, adjustments, investigations, inquires, challenges, Actions or notices of intent facts that would be reasonably likely to audit or investigate by any Governmental Program or Governmental Entity result in (A) a Safety Notice with respect to enrollment eligibilitysuch products, compliance with conditions (B) a change in labeling of participation or paymentany such products, or claims, reports (C) a termination or other submissions by Holdings suspension of marketing or testing of any of its Subsidiaries. (e) Neither Holdings, nor any of its Subsidiaries has made since January 1, 2013, or is in the process of making, any voluntary self-disclosure to any Governmental Program or Governmental Entity, including without limitation any voluntary self-disclosures to the Centers for Medicare & Medicaid Services pursuant to the Medicare self-referral disclosure protocol or to the Office of the Inspector General pursuant to its self-disclosure protocol, or to any United States Attorney. To the Knowledge of Holdings, none of Holdings, its Subsidiaries or any of its Holdings Healthcare Professionals are mentioned in any voluntary self-disclosure made to any Governmental Entity by any healthcare facility or any other Personsuch products. (f) None of Holdings, its Subsidiaries or, Except as has not had and would not reasonably be expected to the Knowledge of Holdings, any Holdings Healthcare Professional is a party to, or bound by, any Order, corporate integrity agreement, deferred prosecution agreement, settlement agreement or other written agreement with any Governmental Entity concerning compliance with Health Care Laws thathave, individually or in the aggregate, have a Holdings Sirona Material Adverse Effect, (i) the clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by Sirona or its Subsidiaries or in which Sirona or its Subsidiaries, or any of their products or product candidates have participated were, and if still pending are, being conducted in accordance with standard medical and scientific research procedures and all applicable Laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 812 and (ii) no investigational device exemption filed by or on behalf of Sirona or its Subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Governmental Entity has commenced, or, to the Knowledge of Sirona, threatened to commence, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Sirona and its Subsidiaries. (g) Holdings and Neither Sirona nor any of its Subsidiaries have instituted and operate in accordance with a compliance plan which is consistent with guidance the subject of the Office of Inspector General of the United States Department of Health & Human Services. (h) None of Holdings and its Subsidiaries has received notice of andany pending or, to the Knowledge of HoldingsSirona, there is and has been no individual complaintthreatened investigation in respect of Sirona, pending or threatened litigation, legal proceeding (in law or in equity) or governmental or administrative investigation, settlement or penalty with respect to Holdings or any of its Subsidiaries or their respective Workforces products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (as defined September 10, 1991) and any amendments thereto. Since June 30, 2012, neither Sirona nor, to the Knowledge of Sirona, any of their officers, employees or agents (within the meaning of the applicable Law) has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under HIPAA(i) uses 21 U.S.C. Section 335a or disclosures of(ii) any similar Law. As of the date hereof, or security practices regarding, individually identifiable health information, uses or disclosures of, or security practices regarding, individually identifiable health information, in each case no Proceedings that would reasonably be material expected to Holdings and result in such a debarment or exclusion are pending or, to the Knowledge of Sirona, threatened against Sirona, its Subsidiaries, taken as a whole. To the Knowledge of Holdings, no Breach (as defined at 45 C.F.R. § 164.402) has occurred with respect to any unsecured PHI maintained by or for Holdings or any of its Subsidiaries that is subject to the notification requirements of 45 C.F.R. Part 164their officers, Subpart D § 164.406 employees or 164.408(b). To the Knowledge of Holdings, any Security Incidents (as defined at 45 C.F.R. § 164.304) involving unsecured PHI maintained by or for Holdings or any of its Subsidiaries have been Unsuccessful Security Incidents or non-material Security Incidents. None of Holdings and its Subsidiaries has notified the media or any Governmental Authority of any Breach as required by 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b), and none of Holdings and its Subsidiaries is currently planning to conduct any such notification or is investigating whether any such notification to the media or any Governmental Authority is required. Each of Holdings and its Subsidiaries has in place, and has complied and is in compliance with, written policies to protect the security and privacy of PHI. Each of Holdings and its Subsidiaries has the right pursuant to its contracts and its privacy and security policies to use and disclose PHI for the purposes for which such information is and has been used and disclosed. Neither the execution, delivery or performance of this Agreement, nor the consummation of any of the transactions contemplated by this Agreement, including any transfer of PHI resulting from such transactions, will violate any policies of Holdings or its Subsidiaries or any privacy agreements to which Holdings or its Subsidiaries are a party as such policies or privacy agreements currently exist or as existed at any time during which any of such PHI was collected or obtainedagents.

Healthcare Compliance Matters. (a) Except as set forth on Section 5.21 of the Plan Investor Disclosure Schedule (i) Holdings and each of its Subsidiaries are Plan Investor Group Member is in compliance with and since January 1, 2013 have not violated any 2017 has been in compliance with all Health Care Law Laws applicable to Holdings such Plan Investor Group Member or any of its Subsidiaries or any items or services provided by or assets owned or used by any of them (except for such past noncompliance as has been remedied and imposes no continuing obligations or costs on Holdings or its Subsidiaries), it and (ii) neither Holdings nor any of its Subsidiaries no Plan Investor Group Member has received any written communication or has been subject to any Proceeding (other than routine FDA inspections) since January 1, 2013 2017 from a Governmental Entity alleging that Holdings or any of its Subsidiaries alleges that such Plan Investor Group Member is or was not, or may not be, in compliance with any Health Care Law, except in the case of the immediately foregoing clauses (i) and (ii) where any actual or alleged non-compliance, individually or in the aggregate, compliance has not had and would not reasonably be expected to have, individually or in the aggregate, a Holdings Plan Investor Material Adverse Effect. Neither Holdings norExcept as set forth on Section 5.21 of the Plan Investor Disclosure Schedule, to the Knowledge of Holdings, any of its Subsidiaries (i) no Plan Investor Group Member is a party to or and has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity. Additionally, none of Holdings, its Subsidiaries and (ii) no Plan Investor Group Member or any of its respective employees, officers or directors or any Holdings Healthcare Professional has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or, to the Knowledge of Holdingsthe Plan Investor, has been convicted of any crime or is subject to a governmental inquiry, investigation, Proceeding, any Proceeding by any Governmental Entity or other similar action, or has engaged in any conduct, that could reasonably be expected to result in debarment, suspension, or exclusion. (b) Except as Each Plan Investor Group Member has, maintains and is operating in material compliance with all Health Care Permits, and all such Health Care Permits are valid, subsisting, and in full force and effect, except where the failure to have, maintain or operate in compliance with the Health Care Permits has not had and would not reasonably be expected to have, individually or in the aggregate, a Holdings Plan Investor Material Adverse Effect, neither Holdings nor its current or former Subsidiaries nor, to the Knowledge of Holdings, any of the owners, managers, officers, directors, employees or contractors of Holdings or any . Each Plan Investor Group Member has fulfilled and performed all of its Subsidiaries or any Holdings Healthcare Professional have been since January 1, 2013 through the date hereof: (i) convicted of, charged with or, to the Knowledge of Holdings, investigated by a Governmental Entity for any violation of any Laws or other misconduct related to any Governmental Program, (ii) convicted of, charged with or, to the Knowledge of Holdings, investigated by a Governmental Entity for a violation of any Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances related to the business or operations of Holdings or any of its Subsidiaries, (iii) excluded, suspended or debarred from, or otherwise ineligible to participate in, any Governmental Program, nor, to the Knowledge of Holdings, is any such exclusion, suspension or bar pending or threatened, or (iv) subject to any Order obligations with respect to the business Health Care Permits, and no event has occurred which allows, or operations with notice or lapse of Holdings time or both, would allow revocation or termination thereof or results in any other material impairment of its Subsidiaries. (c) To the Knowledge rights of Holdings and the holder of any Health Care Permit, except where the failure to so fulfill or perform, or the occurrence of such noncompliance, individually or in the aggregateevent, has not had and would not reasonably be expected to have, a Holdings Material Adverse Effect, each of the Persons performing clinical or professional healthcare services, including without limitation all physicians, mid-level providers (e.g., nurse practitioners, physician assistants, certified-registered nurse anesthetists), nurses paramedics, emergency medical technicians, or any other clinical staff on behalf of Holdings or its Subsidiaries, whether as an employee or independent contractor (each, a “Holdings Healthcare Professional” and collectively, the “Holdings Healthcare Professionals”): (i) has maintained and currently holds, in good standing, all Permits required by any applicable Law or Governmental Entity to perform the services in the states that such Holdings Healthcare Professional is practicing or performing professional services on behalf of Holdings or any of its Subsidiaries; and (ii) to the extent required, has been granted and continues to hold requisite staff privileges at, and is currently, and since January 1, 2013 has been, in good standing with, each of the hospitals and other healthcare facilities at or for which such Holdings Healthcare Professional performs medical services on behalf of Holdings or its Subsidiaries. To the Knowledge of Holdings, each Holdings Healthcare Professional has been and is in compliance with the terms and conditions of such Permits, except where such noncompliance would not, individually or in the aggregate, have a Holdings Plan Investor Material Adverse Effect. To There is no Proceeding pending or, to the Knowledge of Holdingsthe Plan Investor, as of threatened in writing that could result in the date hereofsuspension, neither Holdings nor any of its Subsidiaries has received written notice that any Holdings Healthcare Professional is under investigation bytermination, the subject of a self-disclosure torevocation, cancellation, limitation or is not in good standing with, any Governmental Program or Governmental Entity, except where an unfavorable decision, ruling or finding impairment of any such investigation or disclosure would not, individually or in the aggregate, Health Care Permit other than those that have a Holdings Material Adverse Effect. With respect to Holdings Healthcare Professionals engaged on an independent contractor basis, Holdings or its Subsidiary has insured not had and insures, and maintains a certificate of insurance from each Holdings Healthcare Professional evidencing, that such Holdings Healthcare Professionals have in place malpractice insurance, except where such failure to maintain such insurance would not, individually or in the aggregate, have a Holdings Material Adverse Effect. (d) Except as would not reasonably be expected to have, individually or in the aggregate, a Holdings Plan Investor Material Adverse Effect, . (ic) Holdings Except as has not had and its Subsidiaries are each qualified for participation with, or currently participates with, all Governmental Programs and Private Programs from which such entity seeks or receives reimbursement for items or services, (ii) the billing practices of Holdings and its Subsidiaries to all customers, private individuals or patients, Governmental Programs and Private Programs have been and are in material compliance with applicable Health Care Laws, the HCPCS code set, and rules of applicable Governmental Programs, and (iii) neither Holdings nor any of its Subsidiaries has (a) billed, received or failed, whether on its behalf or on behalf of another Person, to timely return any material payment or reimbursement in excess of amounts allowed by applicable Health Care Laws, or (b) any material outstanding overpayments, refunds or Liability due to any Governmental Program or Governmental Entity. Except to the extent qualifying as ordinary course and except as would not reasonably be expected to have, individually or in the aggregate, a Holdings Plan Investor Material Adverse Effect, there are no pending appealsall applications, adjustmentsnotifications, investigationssubmissions, inquiresinformation, challenges, Actions or notices of intent to audit or investigate by any Governmental Program or Governmental Entity with respect to enrollment eligibility, compliance with conditions of participation or payment, or claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Health Care Permit relating to any Plan Investor Group Member, its business and product candidates, when submitted to the FDA, DEA or other submissions by Holdings Governmental Entity were true, complete and correct as of the date of submission and any necessary or any of its Subsidiariesrequired updates, changes, corrections or modification to such applications, submissions, information and data have been submitted to the FDA, DEA or other Governmental Entity. (ed) Neither Holdings, nor any of its Subsidiaries Except as has made since January 1, 2013, or is in the process of making, any voluntary self-disclosure not had and would not reasonably be expected to any Governmental Program or Governmental Entity, including without limitation any voluntary self-disclosures to the Centers for Medicare & Medicaid Services pursuant to the Medicare self-referral disclosure protocol or to the Office of the Inspector General pursuant to its self-disclosure protocol, or to any United States Attorney. To the Knowledge of Holdings, none of Holdings, its Subsidiaries or any of its Holdings Healthcare Professionals are mentioned in any voluntary self-disclosure made to any Governmental Entity by any healthcare facility or any other Person. (f) None of Holdings, its Subsidiaries or, to the Knowledge of Holdings, any Holdings Healthcare Professional is a party to, or bound by, any Order, corporate integrity agreement, deferred prosecution agreement, settlement agreement or other written agreement with any Governmental Entity concerning compliance with Health Care Laws thathave, individually or in the aggregate, have a Holdings Plan Investor Material Adverse Effect, since January 1, 2017, no Plan Investor Group Member had any product, product candidate or manufacturing site subject to a Governmental Entity (including FDA or DEA) shutdown or import or export prohibition, and has not received any FDA Form 483 or other Governmental Entity notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make changes to a product candidate, or similar correspondence or written notice from the FDA, DEA or other Governmental Entity alleging or asserting noncompliance with any applicable Health Care Law, Health Care Permit or such requests or requirements of a Governmental Entity. (ge) Holdings Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Plan Investor Material Adverse Effect, (i) the clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by any Plan Investor Group Member or in which any Plan Investor Group Member, or any of its Subsidiaries product candidates have instituted participated were, and operate if still pending are, being conducted in accordance with a compliance plan which is consistent with guidance of standard medical and scientific research procedures and all applicable Laws, including, but not limited to, the Office of Inspector General of the United States Department of Health & Human Services. (h) None of Holdings Federal Food, Drug and Cosmetic Act and its Subsidiaries applicable implementing regulations and (ii) no investigational new drug application filed by or on behalf of any Plan Investor Group Member with the FDA has received notice of andbeen terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Governmental Entity has commenced, or, to the Knowledge of Holdingsthe Plan Investor, there is and has been no individual complaintthreatened to commence, pending or threatened litigation, legal proceeding (in law or in equity) or governmental or administrative investigation, settlement or penalty with respect any action to Holdings or any of its Subsidiaries or their respective Workforces (as defined under HIPAA) uses or disclosures ofplace a clinical hold order on, or security practices regardingotherwise terminate, individually identifiable health informationdelay or suspend, uses any proposed or disclosures ofongoing clinical investigation conducted or proposed to be conducted by or on behalf of any Plan Investor Group Member. (f) No Plan Investor Group Member is the subject of any pending or, or security practices regarding, individually identifiable health information, in each case that would be material to Holdings and its Subsidiaries, taken as a whole. To the Knowledge of Holdingsthe Plan Investor, no Breach (as defined at 45 C.F.R. § 164.402) has occurred with threatened investigation in respect to any unsecured PHI maintained of such Plan Investor Group Member or its product candidates, by or for Holdings or any of its Subsidiaries that is subject to the notification requirements of 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b). To the Knowledge of Holdings, any Security Incidents (as defined at 45 C.F.R. § 164.304) involving unsecured PHI maintained by or for Holdings or any of its Subsidiaries have been Unsuccessful Security Incidents or non-material Security Incidents. None of Holdings and its Subsidiaries has notified the media or any Governmental Authority of any Breach as required by 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b), and none of Holdings and its Subsidiaries is currently planning to conduct any such notification or is investigating whether any such notification to the media or any Governmental Authority is required. Each of Holdings and its Subsidiaries has in place, and has complied and is in compliance with, written policies to protect the security and privacy of PHI. Each of Holdings and its Subsidiaries has the right FDA pursuant to its contracts “Fraud, Untrue Statements of Material Facts, Bribery, and its privacy Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and security policies any amendments thereto. The Plan Investor has provided the Company with accurate and complete copies of all Health Care Permits and correspondence with any Governmental Entity related to use and disclose PHI for the purposes for which such information is and has been used and disclosed. Neither the execution, delivery or performance of this Agreement, nor the consummation all product candidates of any of the transactions contemplated by this Agreement, including any transfer of PHI resulting from such transactions, will violate any policies of Holdings or its Subsidiaries or any privacy agreements to which Holdings or its Subsidiaries are a party as such policies or privacy agreements currently exist or as existed at any time during which any of such PHI was collected or obtainedPlan Investor Group Member.

Healthcare Compliance Matters. (i) Holdings DENTSPLY and each of its Subsidiaries are in compliance with and since January 1June 30, 2013 2012 have not violated any been in compliance with all Health Care Law Laws applicable to Holdings DENTSPLY or any of its Subsidiaries or any items or services provided by or assets owned or used by any of them (except for such past noncompliance as has been remedied and imposes no continuing obligations or costs on Holdings DENTSPLY or its Subsidiaries), and (ii) neither Holdings DENTSPLY nor any of its Subsidiaries has received any written communication since January 1June 30, 2013 2012 from a Governmental Entity alleging that Holdings remains uncured or unresolved and that alleges that DENTSPLY or any of its Subsidiaries is or was not, or may not be, in compliance with any Health Care Law, except in the case of clauses (i) and (ii) where any actual or alleged non-compliance, individually or in the aggregate, has not had and would not reasonably be expected to have, a Holdings DENTSPLY Material Adverse Effect. Neither Holdings DENTSPLY nor, to the Knowledge of HoldingsDENTSPLY, any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity. Additionally, none of HoldingsDENTSPLY, its Subsidiaries or any of its respective employees, officers or directors or any Holdings Healthcare Professional has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or, to the Knowledge of HoldingsDENTSPLY, has been convicted of any crime or is subject to a governmental inquiry, investigation, Proceeding, or other similar action, or has engaged in any conduct, that could reasonably be expected to result in debarment, suspension, or exclusion. (b) Except as DENTSPLY and each of its Subsidiaries have, maintain and are operating in material compliance with all FDA Permits, and all such FDA Permits are valid, subsisting, and in full force and effect, except where the failure to have, maintain or operate in material compliance with the FDA Permits has not had, and would not reasonably be expected to have, individually or in the aggregate, a Holdings DENTSPLY Material Adverse Effect, neither Holdings nor . DENTSPLY and each of its current or former Subsidiaries nor, have fulfilled and performed all of their material obligations with respect to the Knowledge FDA Permits, and no event has occurred which allows, or with notice or lapse of Holdingstime or both, would allow revocation or termination thereof or results in any other material impairment of the rights of the holder of any FDA Permit, except where the failure to so fulfill or perform, or the occurrence of such event, would not result in a DENTSPLY Material Adverse Effect. DENTSPLY and each of its Subsidiaries have operated and currently are in compliance in all material respects with applicable Laws administered or enforced by the FDA and comparable Governmental Entities, except where the failure to so comply would not result in a DENTSPLY Material Adverse Effect. DENTSPLY and each of its Subsidiaries have not received, since June 30, 2012, written notice of any pending or threatened Proceeding (other than FDA audits) from the FDA, any Governmental Entity, any qui-tam relator or applicable foreign Governmental Entity alleging that any operation or activity of the owners, managers, officers, directors, employees or contractors of Holdings DENTSPLY or any of its Subsidiaries or any Holdings Healthcare Professional have been since January 1, 2013 through the date hereof: (i) convicted of, charged with or, to the Knowledge of Holdings, investigated by a Governmental Entity for any is in material violation of any Laws or other misconduct related applicable Health Care Law which violation would reasonably be expected to any Governmental Program, (ii) convicted of, charged with or, to the Knowledge of Holdings, investigated by have a Governmental Entity for a violation of any Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances related to the business or operations of Holdings or any of material and adverse impact on DENTSPLY and its Subsidiaries, (iii) excluded, suspended or debarred from, or otherwise ineligible to participate in, any Governmental Program, nor, to the Knowledge of Holdings, is any such exclusion, suspension or bar pending or threatened, or (iv) subject to any Order with respect to the business or operations of Holdings or any of its Subsidiariestaken as a whole. (c) To the Knowledge of Holdings and except where such noncompliance, individually or in the aggregate, Except as has not had and would not reasonably be expected to have, a Holdings Material Adverse Effect, each of the Persons performing clinical or professional healthcare services, including without limitation all physicians, mid-level providers (e.g., nurse practitioners, physician assistants, certified-registered nurse anesthetists), nurses paramedics, emergency medical technicians, or any other clinical staff on behalf of Holdings or its Subsidiaries, whether as an employee or independent contractor (each, a “Holdings Healthcare Professional” and collectively, the “Holdings Healthcare Professionals”): (i) has maintained and currently holds, in good standing, all Permits required by any applicable Law or Governmental Entity to perform the services in the states that such Holdings Healthcare Professional is practicing or performing professional services on behalf of Holdings or any of its Subsidiaries; and (ii) to the extent required, has been granted and continues to hold requisite staff privileges at, and is currently, and since January 1, 2013 has been, in good standing with, each of the hospitals and other healthcare facilities at or for which such Holdings Healthcare Professional performs medical services on behalf of Holdings or its Subsidiaries. To the Knowledge of Holdings, each Holdings Healthcare Professional has been and is in compliance with the terms and conditions of such Permits, except where such noncompliance would not, individually or in the aggregate, have a Holdings DENTSPLY Material Adverse Effect. To , all applications, notifications, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the Knowledge basis for or submitted in connection with any and all requests for a FDA Permit from the FDA or other Governmental Entity relating to DENTSPLY and each of Holdingsits Subsidiaries, their business and products, when submitted to the FDA or other Governmental Entity were true, complete and correct as of the date hereofof submission and any necessary or required updates, neither Holdings nor any of its Subsidiaries has received written notice that any Holdings Healthcare Professional is under investigation bychanges, corrections or modification to such applications, submissions, information and data have been submitted to the subject of a self-disclosure to, FDA or is not in good standing with, any Governmental Program or other Governmental Entity, except where an unfavorable decision, ruling or finding of any such investigation or disclosure would not, individually or in the aggregate, have a Holdings Material Adverse Effect. With respect to Holdings Healthcare Professionals engaged on an independent contractor basis, Holdings or its Subsidiary has insured and insures, and maintains a certificate of insurance from each Holdings Healthcare Professional evidencing, that such Holdings Healthcare Professionals have in place malpractice insurance, except where such failure to maintain such insurance would not, individually or in the aggregate, have a Holdings Material Adverse Effect. (d) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Holdings DENTSPLY Material Adverse Effect, (i) Holdings since June 30, 2012, DENTSPLY and its Subsidiaries are each qualified for participation with, or currently participates with, all Governmental Programs and Private Programs from which such entity seeks or receives reimbursement for items or services, (ii) the billing practices of Holdings and its Subsidiaries to all customers, private individuals or patients, Governmental Programs and Private Programs have been and are in material compliance with applicable Health Care Laws, the HCPCS code set, and rules of applicable Governmental Programs, and (iii) neither Holdings nor any of its Subsidiaries has have not had any product or manufacturing site (a) billed, received whether owned by DENTSPLY or failed, whether on its behalf or on behalf of another Person, to timely return any material payment or reimbursement in excess of amounts allowed by applicable Health Care LawsSubsidiary(s), or a contract manufacturer for their products) subject to a Governmental Entity (bincluding FDA) shutdown or import or export prohibition, nor received any material outstanding overpaymentsFDA Form 483 or other Governmental Entity notice of inspectional observations, refunds “warning letters,” “untitled letters” or Liability due requests or requirements to make changes to the products, or similar correspondence or notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any Governmental Program applicable Law, Permit or such requests or requirements of a Governmental Entity. . (e) Except to the extent qualifying as ordinary course has not had and except as would not reasonably be expected to have, individually or in the aggregate, a Holdings DENTSPLY Material Adverse Effect, (i) since June 30, 2012, there have been no (A) Safety Notices with respect to the products of DENTSPLY and its Subsidiaries or (B) to the Knowledge of DENTSPLY, complaints with respect to such products that are currently unresolved and (ii) to the Knowledge of DENTSPLY, there are no pending appeals, adjustments, investigations, inquires, challenges, Actions or notices of intent facts that would be reasonably likely to audit or investigate by any Governmental Program or Governmental Entity result in (A) a Safety Notice with respect to enrollment eligibilitysuch products, compliance with conditions (B) a change in labeling of participation or paymentany such products, or claims, reports (C) a termination or other submissions by Holdings suspension of marketing or testing of any of its Subsidiaries. (e) Neither Holdings, nor any of its Subsidiaries has made since January 1, 2013, or is in the process of making, any voluntary self-disclosure to any Governmental Program or Governmental Entity, including without limitation any voluntary self-disclosures to the Centers for Medicare & Medicaid Services pursuant to the Medicare self-referral disclosure protocol or to the Office of the Inspector General pursuant to its self-disclosure protocol, or to any United States Attorney. To the Knowledge of Holdings, none of Holdings, its Subsidiaries or any of its Holdings Healthcare Professionals are mentioned in any voluntary self-disclosure made to any Governmental Entity by any healthcare facility or any other Personsuch products. (f) None of Holdings, its Subsidiaries or, Except as has not had and would not reasonably be expected to the Knowledge of Holdings, any Holdings Healthcare Professional is a party to, or bound by, any Order, corporate integrity agreement, deferred prosecution agreement, settlement agreement or other written agreement with any Governmental Entity concerning compliance with Health Care Laws thathave, individually or in the aggregate, have a Holdings DENTSPLY Material Adverse Effect, (i) the clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by DENTSPLY or its Subsidiaries or in which DENTSPLY or its Subsidiaries, or any of their products or product candidates have participated were, and if still pending are, being conducted in accordance with standard medical and scientific research procedures and all applicable Laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 812 and (ii) no investigational device exemption filed by or on behalf of DENTSPLY or its Subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Governmental Entity has commenced, or, to the Knowledge of DENTSPLY, threatened to commence, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of DENTSPLY and its Subsidiaries. (g) Holdings and Neither DENTSPLY nor any of its Subsidiaries have instituted and operate in accordance with a compliance plan which is consistent with guidance the subject of the Office of Inspector General of the United States Department of Health & Human Services. (h) None of Holdings and its Subsidiaries has received notice of andany pending or, to the Knowledge of HoldingsDENTSPLY, there is and has been no individual complaintthreatened investigation in respect of DENTSPLY, pending or threatened litigation, legal proceeding (in law or in equity) or governmental or administrative investigation, settlement or penalty with respect to Holdings or any of its Subsidiaries or their respective Workforces products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (as defined September 10, 1991) and any amendments thereto. Since June 30, 2012, neither DENTSPLY nor, to the Knowledge of DENTSPLY, any of their officers, employees or agents (within the meaning of the applicable Law) has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion under HIPAA(i) uses 21 U.S.C. Section 335a or disclosures of(ii) any similar Law. As of the date hereof, or security practices regarding, individually identifiable health information, uses or disclosures of, or security practices regarding, individually identifiable health information, in each case no Proceedings that would reasonably be material expected to Holdings and result in such a debarment or exclusion are pending or, to the Knowledge of DENTSPLY, threatened against DENTSPLY, its Subsidiaries, taken as a whole. To the Knowledge of Holdings, no Breach (as defined at 45 C.F.R. § 164.402) has occurred with respect to any unsecured PHI maintained by or for Holdings or any of its Subsidiaries that is subject to the notification requirements of 45 C.F.R. Part 164their officers, Subpart D § 164.406 employees or 164.408(b). To the Knowledge of Holdings, any Security Incidents (as defined at 45 C.F.R. § 164.304) involving unsecured PHI maintained by or for Holdings or any of its Subsidiaries have been Unsuccessful Security Incidents or non-material Security Incidents. None of Holdings and its Subsidiaries has notified the media or any Governmental Authority of any Breach as required by 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b), and none of Holdings and its Subsidiaries is currently planning to conduct any such notification or is investigating whether any such notification to the media or any Governmental Authority is required. Each of Holdings and its Subsidiaries has in place, and has complied and is in compliance with, written policies to protect the security and privacy of PHI. Each of Holdings and its Subsidiaries has the right pursuant to its contracts and its privacy and security policies to use and disclose PHI for the purposes for which such information is and has been used and disclosed. Neither the execution, delivery or performance of this Agreement, nor the consummation of any of the transactions contemplated by this Agreement, including any transfer of PHI resulting from such transactions, will violate any policies of Holdings or its Subsidiaries or any privacy agreements to which Holdings or its Subsidiaries are a party as such policies or privacy agreements currently exist or as existed at any time during which any of such PHI was collected or obtainedagents.

Healthcare Compliance Matters. (a) Except as set forth on Section 4.21(a) of the Company Disclosure Schedule (i) Holdings and each of its Subsidiaries are Company Group Member is in compliance with and since January 1, 2013 have not violated any 2017 has been in compliance with all Health Care Law Laws applicable to Holdings such Company Group Member or any of its Subsidiaries or any items or services provided by or assets owned or used by any of them (except for such past noncompliance as has been remedied and imposes no continuing obligations or costs on Holdings or its Subsidiaries), it and (ii) neither Holdings nor any of its Subsidiaries no Company Group Member has received any written communication or has been subject to any Proceeding (other than routine FDA inspections) since January 1, 2013 2017 from a Governmental Entity alleging that Holdings or any of its Subsidiaries alleges that such Company Group Member is or was not, or may not be, in compliance with any Health Care Law, except in the case of the immediately foregoing clauses (i) and (ii) where any actual or alleged non-compliance, individually or in the aggregate, compliance has not had and would not reasonably be expected to have, individually or in the aggregate, a Holdings Company Material Adverse Effect. Neither Holdings norExcept as set forth on Section 4.21(a) of the Company Disclosure Schedule, to the Knowledge of Holdings, any of its Subsidiaries (i) no Company Group Member is a party to or and has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity. Additionally, none of Holdings, its Subsidiaries and (ii) no Company Group Member or any of its respective employees, officers or directors or any Holdings Healthcare Professional has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or, to the Knowledge of Holdingsthe Company, has been convicted of any crime or is subject to a governmental inquiry, investigation, Proceeding, any Proceeding by any Governmental Entity or other similar action, or has engaged in any conduct, that could reasonably be expected to result in debarment, suspension, or exclusion. (b) Except as Each Company Group Member has, maintains and is operating in material compliance with all Permits of the United States Food and Drug Administration (“FDA”), Drug Enforcement Administration (“DEA”), and comparable Governmental Entities which are required for the conduct of the Company Business (collectively, the “Health Care Permits”), and all such Health Care Permits are valid, subsisting, and in full force and effect, except where the failure to have, maintain or operate in compliance with the Health Care Permits has not had and would not reasonably be expected to have, individually or in the aggregate, a Holdings Company Material Adverse Effect, neither Holdings nor its current or former Subsidiaries nor, to the Knowledge of Holdings, any of the owners, managers, officers, directors, employees or contractors of Holdings or any . Each Company Group Member has fulfilled and performed all of its Subsidiaries or any Holdings Healthcare Professional have been since January 1, 2013 through the date hereof: (i) convicted of, charged with or, to the Knowledge of Holdings, investigated by a Governmental Entity for any violation of any Laws or other misconduct related to any Governmental Program, (ii) convicted of, charged with or, to the Knowledge of Holdings, investigated by a Governmental Entity for a violation of any Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances related to the business or operations of Holdings or any of its Subsidiaries, (iii) excluded, suspended or debarred from, or otherwise ineligible to participate in, any Governmental Program, nor, to the Knowledge of Holdings, is any such exclusion, suspension or bar pending or threatened, or (iv) subject to any Order obligations with respect to the business Health Care Permits, and no event has occurred which allows, or operations with notice or lapse of Holdings time or both, would allow revocation or termination thereof or results in any other material impairment of its Subsidiaries. (c) To the Knowledge rights of Holdings and the holder of any Health Care Permit, except where the failure to so fulfill or perform, or the occurrence of such noncompliance, individually or in the aggregateevent, has not had and would not reasonably be expected to have, a Holdings Material Adverse Effect, each of the Persons performing clinical or professional healthcare services, including without limitation all physicians, mid-level providers (e.g., nurse practitioners, physician assistants, certified-registered nurse anesthetists), nurses paramedics, emergency medical technicians, or any other clinical staff on behalf of Holdings or its Subsidiaries, whether as an employee or independent contractor (each, a “Holdings Healthcare Professional” and collectively, the “Holdings Healthcare Professionals”): (i) has maintained and currently holds, in good standing, all Permits required by any applicable Law or Governmental Entity to perform the services in the states that such Holdings Healthcare Professional is practicing or performing professional services on behalf of Holdings or any of its Subsidiaries; and (ii) to the extent required, has been granted and continues to hold requisite staff privileges at, and is currently, and since January 1, 2013 has been, in good standing with, each of the hospitals and other healthcare facilities at or for which such Holdings Healthcare Professional performs medical services on behalf of Holdings or its Subsidiaries. To the Knowledge of Holdings, each Holdings Healthcare Professional has been and is in compliance with the terms and conditions of such Permits, except where such noncompliance would not, individually or in the aggregate, have a Holdings Company Material Adverse Effect. To There is no Proceeding pending or, to the Knowledge of Holdingsthe Company, as of threatened in writing that could result in the date hereofsuspension, neither Holdings nor any of its Subsidiaries has received written notice that any Holdings Healthcare Professional is under investigation bytermination, the subject of a self-disclosure torevocation, cancellation, limitation or is not in good standing with, any Governmental Program or Governmental Entity, except where an unfavorable decision, ruling or finding impairment of any such investigation or disclosure would not, individually or in the aggregate, Health Care Permit other than those that have a Holdings Material Adverse Effect. With respect to Holdings Healthcare Professionals engaged on an independent contractor basis, Holdings or its Subsidiary has insured not had and insures, and maintains a certificate of insurance from each Holdings Healthcare Professional evidencing, that such Holdings Healthcare Professionals have in place malpractice insurance, except where such failure to maintain such insurance would not, individually or in the aggregate, have a Holdings Material Adverse Effect. (d) Except as would not reasonably be expected to have, individually or in the aggregate, a Holdings Company Material Adverse Effect, . (ic) Holdings Except as has not had and its Subsidiaries are each qualified for participation with, or currently participates with, all Governmental Programs and Private Programs from which such entity seeks or receives reimbursement for items or services, (ii) the billing practices of Holdings and its Subsidiaries to all customers, private individuals or patients, Governmental Programs and Private Programs have been and are in material compliance with applicable Health Care Laws, the HCPCS code set, and rules of applicable Governmental Programs, and (iii) neither Holdings nor any of its Subsidiaries has (a) billed, received or failed, whether on its behalf or on behalf of another Person, to timely return any material payment or reimbursement in excess of amounts allowed by applicable Health Care Laws, or (b) any material outstanding overpayments, refunds or Liability due to any Governmental Program or Governmental Entity. Except to the extent qualifying as ordinary course and except as would not reasonably be expected to have, individually or in the aggregate, a Holdings Company Material Adverse Effect, there are no pending appealsall applications, adjustmentsnotifications, investigationssubmissions, inquiresinformation, challenges, Actions or notices of intent to audit or investigate by any Governmental Program or Governmental Entity with respect to enrollment eligibility, compliance with conditions of participation or payment, or claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Health Care Permit relating to any Company Group Member, its business and product candidates, when submitted to the FDA, DEA or other submissions by Holdings Governmental Entity were true, complete and correct as of the date of submission and any necessary or any of its Subsidiariesrequired updates, changes, corrections or modification to such applications, submissions, information and data have been submitted to the FDA, DEA or other Governmental Entity. (ed) Neither Holdings, nor any of its Subsidiaries Except as has made since January 1, 2013, or is in the process of making, any voluntary self-disclosure not had and would not reasonably be expected to any Governmental Program or Governmental Entity, including without limitation any voluntary self-disclosures to the Centers for Medicare & Medicaid Services pursuant to the Medicare self-referral disclosure protocol or to the Office of the Inspector General pursuant to its self-disclosure protocol, or to any United States Attorney. To the Knowledge of Holdings, none of Holdings, its Subsidiaries or any of its Holdings Healthcare Professionals are mentioned in any voluntary self-disclosure made to any Governmental Entity by any healthcare facility or any other Person. (f) None of Holdings, its Subsidiaries or, to the Knowledge of Holdings, any Holdings Healthcare Professional is a party to, or bound by, any Order, corporate integrity agreement, deferred prosecution agreement, settlement agreement or other written agreement with any Governmental Entity concerning compliance with Health Care Laws thathave, individually or in the aggregate, have a Holdings Company Material Adverse Effect, January 1, 2017, no Company Group Member had any product, product candidate or manufacturing site subject to a Governmental Entity (including FDA or DEA) shutdown or import or export prohibition, and has not received any FDA Form 483 or other Governmental Entity notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make changes to a product candidate, or similar correspondence or written notice from the FDA, DEA or other Governmental Entity alleging or asserting noncompliance with any applicable Health Care Law, Health Care Permit or such requests or requirements of a Governmental Entity. (ge) Holdings Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, (i) the clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by any Company Group Member or in which any Company Group Member, or any of its Subsidiaries product candidates have instituted participated were, and operate if still pending are, being conducted in accordance with a compliance plan which is consistent with guidance of standard medical and scientific research procedures and all applicable Laws, including, but not limited to, the Office of Inspector General of the United States Department of Health & Human Services. (h) None of Holdings Federal Food, Drug and Cosmetic Act and its Subsidiaries applicable implementing regulations and (ii) no investigational new drug application filed by or on behalf of any Company Group Member with the FDA has received notice of andbeen terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Governmental Entity has commenced, or, to the Knowledge of Holdingsthe Company, there is and has been no individual complaintthreatened to commence, pending or threatened litigation, legal proceeding (in law or in equity) or governmental or administrative investigation, settlement or penalty with respect any action to Holdings or any of its Subsidiaries or their respective Workforces (as defined under HIPAA) uses or disclosures ofplace a clinical hold order on, or security practices regardingotherwise terminate, individually identifiable health informationdelay or suspend, uses any proposed or disclosures ofongoing clinical investigation conducted or proposed to be conducted by or on behalf of any Company Group Member. (f) No Company Group Member is the subject of any pending or, or security practices regarding, individually identifiable health information, in each case that would be material to Holdings and its Subsidiaries, taken as a whole. To the Knowledge of Holdingsthe Company, no Breach (as defined at 45 C.F.R. § 164.402) has occurred with threatened investigation in respect to any unsecured PHI maintained of such Company Group Member or its product candidates, by or for Holdings or any of its Subsidiaries that is subject to the notification requirements of 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b). To the Knowledge of Holdings, any Security Incidents (as defined at 45 C.F.R. § 164.304) involving unsecured PHI maintained by or for Holdings or any of its Subsidiaries have been Unsuccessful Security Incidents or non-material Security Incidents. None of Holdings and its Subsidiaries has notified the media or any Governmental Authority of any Breach as required by 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b), and none of Holdings and its Subsidiaries is currently planning to conduct any such notification or is investigating whether any such notification to the media or any Governmental Authority is required. Each of Holdings and its Subsidiaries has in place, and has complied and is in compliance with, written policies to protect the security and privacy of PHI. Each of Holdings and its Subsidiaries has the right FDA pursuant to its contracts “Fraud, Untrue Statements of Material Facts, Bribery, and its privacy Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and security policies any amendments thereto. The Company has provided the Plan Investor with accurate and complete copies of all Health Care Permits and correspondence with any Governmental Entity related to use and disclose PHI for the purposes for which such information is and has been used and disclosed. Neither the execution, delivery or performance of this Agreement, nor the consummation all product candidates of any of the transactions contemplated by this Agreement, including any transfer of PHI resulting from such transactions, will violate any policies of Holdings or its Subsidiaries or any privacy agreements to which Holdings or its Subsidiaries are a party as such policies or privacy agreements currently exist or as existed at any time during which any of such PHI was collected or obtainedCompany Group Member.

Healthcare Compliance Matters. (i) Holdings AmSurg and each of its Subsidiaries are in compliance with and since January 1, 2013 have not violated any Health Care Law applicable to Holdings AmSurg or any of its Subsidiaries or any items or services provided by or assets owned or used by any of them (except for such past noncompliance as has been remedied and imposes no continuing obligations or costs on Holdings AmSurg or its Subsidiaries), and (ii) neither Holdings AmSurg nor any of its Subsidiaries has received any written communication since January 1, 2013 from a Governmental Entity alleging that Holdings AmSurg or any of its Subsidiaries is or was not, or may not be, in compliance with any Health Care Law, except in the case of clauses (i) and (ii) where any actual or alleged non-compliance, individually or in the aggregate, has not had and would not reasonably be expected to have, a Holdings an AmSurg Material Adverse Effect. Neither Holdings AmSurg nor, to the Knowledge of HoldingsAmSurg, any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity. Additionally, none of HoldingsAmSurg, its Subsidiaries or any of its respective employees, officers or directors or any Holdings AmSurg Healthcare Professional has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or, to the Knowledge of HoldingsAmSurg, has been convicted of any crime or is subject to a governmental inquiry, investigation, Proceeding, or other similar action, or has engaged in any conduct, that could reasonably be expected to result in debarment, suspension, or exclusion. (b) Except as would not have, individually or in the aggregate, a Holdings an AmSurg Material Adverse Effect, neither Holdings AmSurg nor its current or former Subsidiaries nor, to the Knowledge of HoldingsAmSurg, any of the owners, managers, officers, directors, employees or contractors of Holdings AmSurg or any of its Subsidiaries or any Holdings AmSurg Healthcare Professional have been since January 1, 2013 through the date hereof: (i) convicted of, charged with or, to the Knowledge of HoldingsAmSurg, investigated by a Governmental Entity for any violation of any Laws or other misconduct related to any Governmental Program, (ii) convicted of, charged with or, to the Knowledge of HoldingsAmSurg, investigated by a Governmental Entity for a violation of any Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances related to the business or operations of Holdings AmSurg or any of its Subsidiaries, (iii) excluded, suspended or debarred from, or otherwise ineligible to participate in, any Governmental Program, nor, to the Knowledge of HoldingsAmSurg, is any such exclusion, suspension or bar pending or threatened, or (iv) subject to any Order with respect to the business or operations of Holdings AmSurg or any of its Subsidiaries. (c) To the Knowledge of Holdings AmSurg and except where such noncompliance, individually or in the aggregate, has not had and would not reasonably be expected to have, a Holdings an AmSurg Material Adverse Effect, each of the Persons performing clinical or professional healthcare services, including without limitation all physicians, mid-level providers (e.g., nurse practitioners, physician assistants, certified-registered nurse anesthetists), nurses nurses, paramedics, emergency medical technicians, or any other clinical staff on behalf of Holdings AmSurg or its Subsidiaries, whether as an employee or independent contractor (each, a an “Holdings AmSurg Healthcare Professional” and collectively, the “Holdings AmSurg Healthcare Professionals”): (i) has maintained and currently holds, in good standing, all Permits required by any applicable Law or Governmental Entity to perform the services in the states that such Holdings AmSurg Healthcare Professional is practicing or performing professional services on behalf of Holdings AmSurg or any of its Subsidiaries; and (ii) to the extent required, has been granted and continues to hold requisite staff privileges at, and is currently, and since January 1, 2013 has been, in good standing with, each of the hospitals and other healthcare facilities at or for which such Holdings AmSurg Healthcare Professional performs medical services on behalf of Holdings AmSurg or its Subsidiaries. To the Knowledge of HoldingsAmSurg, each Holdings AmSurg Healthcare Professional has been and is in compliance with the terms and conditions of such Permits, except where such noncompliance would not, individually or in the aggregate, have a Holdings an AmSurg Material Adverse Effect. To the Knowledge of HoldingsAmSurg, as of the date hereof, neither Holdings AmSurg nor any of its Subsidiaries has received written notice that any Holdings AmSurg Healthcare Professional is under investigation by, the subject of a self-disclosure to, or is not in good standing with, any Governmental Program or Governmental Entity, except where an unfavorable decision, ruling or finding of any such investigation or disclosure would not, individually or in the aggregate, have a Holdings an AmSurg Material Adverse Effect. With respect to Holdings AmSurg Healthcare Professionals engaged on an independent contractor basis, Holdings AmSurg or its Subsidiary has insured and insures, and maintains a certificate of insurance from each Holdings AmSurg Healthcare Professional evidencing, that such Holdings AmSurg Healthcare Professionals have in place malpractice insurance, except where such failure to maintain such insurance would not, individually or in the aggregate, have a Holdings an AmSurg Material Adverse Effect. (d) Except as would not have, individually or in the aggregate, a Holdings an AmSurg Material Adverse Effect, (i) Holdings AmSurg and its Subsidiaries are each qualified for participation with, or currently participates with, all Governmental Programs and Private Programs from which such entity seeks or receives reimbursement for items or services, (ii) the billing practices of Holdings AmSurg and its Subsidiaries to all customers, private individuals or patients, Governmental Programs and Private Programs have been and are in material compliance with applicable Health Care Laws, the HCPCS Health Care Common Procedure Coding System (“HCPCS”) code set, and rules of applicable Governmental Programs, and (iii) neither Holdings AmSurg nor any of its Subsidiaries has (a) billed, received or failed, whether on its behalf or on behalf of another Person, to timely return any material payment or reimbursement in excess of amounts allowed by applicable Health Care Laws, or (b) any material outstanding overpayments, refunds or Liability due to any Governmental Program or Governmental Entity. Except to the extent qualifying as ordinary course and except as would not have, individually or in the aggregate, a Holdings an AmSurg Material Adverse Effect, there are no pending appeals, adjustments, investigations, inquires, challenges, Actions or notices of intent to audit or investigate by any Governmental Program or Governmental Entity with respect to enrollment eligibility, compliance with conditions of participation or payment, or claims, reports or other submissions by Holdings AmSurg or any of its Subsidiaries. (e) Neither HoldingsAmSurg, nor any of its Subsidiaries has made since January 1, 2013, or is in the process of making, any voluntary self-disclosure to any Governmental Program or Governmental Entity, including without limitation any voluntary self-disclosures to the Centers for Medicare & Medicaid Services pursuant to the Medicare self-referral disclosure protocol or to the Office of the Inspector General pursuant to its self-disclosure protocol, or to any United States Attorney. To the Knowledge of HoldingsAmSurg, none of HoldingsAmSurg, its Subsidiaries or any of its Holdings AmSurg Healthcare Professionals are mentioned in any voluntary self-disclosure made to any Governmental Entity by any healthcare facility or any other Person. (f) None of HoldingsAmSurg, its Subsidiaries or, to the Knowledge of HoldingsAmSurg, any Holdings AmSurg Healthcare Professional is a party to, or bound by, any Order, corporate integrity agreement, deferred prosecution agreement, settlement agreement or other written agreement with any Governmental Entity concerning compliance with Health Care Laws that, individually or in the aggregate, have a Holdings an AmSurg Material Adverse Effect. (g) Holdings AmSurg and its Subsidiaries have instituted and operate in accordance with a compliance plan which is consistent with guidance of the Office of Inspector General of the United States Department of Health & Human Services. (h) None of Holdings AmSurg and its Subsidiaries has received notice of and, to the Knowledge of HoldingsAmSurg, there is and has been no individual complaint, pending or threatened litigation, legal proceeding (in law or in equity) or governmental or administrative investigation, settlement or penalty with respect to Holdings AmSurg or any of its Subsidiaries or their respective Workforces (as defined under HIPAA) uses or disclosures of, or security practices regarding, individually identifiable health information, uses or disclosures of, or security practices regarding, individually identifiable health information, in each case that would be material to Holdings AmSurg and its Subsidiaries, taken as a whole. To the Knowledge of HoldingsAmSurg, no Breach (as defined at 45 C.F.R. § 164.402) has occurred with respect to any unsecured PHI Protected Health Information (as defined in 45 C.F.R. § 160.103) (“PHI”) maintained by or for Holdings AmSurg or any of its Subsidiaries that is subject to the notification requirements of 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b). To the Knowledge of HoldingsAmSurg, any Security Incidents (as defined at 45 C.F.R. § 164.304) involving unsecured PHI maintained by or for Holdings AmSurg or any of its Subsidiaries have been Unsuccessful Security Incidents or non-material Security Incidents. For purposes of this Agreement, “Unsuccessful Security Incidents” include, but are not limited to, pings and other broadcast attacks on AmSurg’s firewall, port scans, unsuccessful log-on attempts, denials of service and any combination of the above, so long as no such incident results in unauthorized access, use or disclosure of PHI. None of Holdings AmSurg and its Subsidiaries has notified the media or any Governmental Authority of any Breach as required by 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b), and none of Holdings AmSurg and its Subsidiaries is currently planning to conduct any such notification or is investigating whether any such notification to the media or any Governmental Authority is required. Each of Holdings AmSurg and its Subsidiaries has in place, and has complied and is in compliance with, written policies to protect the security and privacy of PHI. Each of Holdings AmSurg and its Subsidiaries has the right pursuant to its contracts and its privacy and security policies to use and disclose PHI for the purposes for which such information is and has been used and disclosed. Neither the execution, delivery or performance of this Agreement, nor the consummation of any of the transactions contemplated by this Agreement, including any transfer of PHI resulting from such transactions, will violate any policies of Holdings AmSurg or its Subsidiaries or any privacy agreements to which Holdings AmSurg or its Subsidiaries are a party as such policies or privacy agreements currently exist or as existed at any time during which any of such PHI was collected or obtained.

Healthcare Compliance Matters. (i) Holdings and each of its Subsidiaries are Each Company Entity is in compliance and, for the past three (3) years has been in material compliance with and since January 1, 2013 have not violated any Health Care Law all Healthcare Laws applicable to Holdings it or any of its Subsidiaries or any items or services provided by or assets owned or used by any of them Company Entity (except other than for such past noncompliance as has been remedied and imposes no continuing obligations or costs on Holdings or its Subsidiaries), any Company Entity) and (ii) neither Holdings nor any none of its Subsidiaries the Company Entities has received any written communication since January 1, 2013 in the past three (3) years from a Governmental Authority that remains uncured or unresolved and that alleges that any Company Entity alleging that Holdings or any of its Subsidiaries is or was not, or may not be, in compliance with any Health Care Healthcare Law, except in the case of clauses (i) and (ii) where any actual or alleged non-compliance, individually or in the aggregate, has not had and would not reasonably be expected to have, a Holdings Material Adverse Effect. Neither Holdings nor, to the Knowledge of Holdings, any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity. Additionally, none of Holdings, its Subsidiaries or any of its respective employees, officers or directors or any Holdings Healthcare Professional has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or, to the Knowledge of Holdings, has been convicted of any crime or is subject to a governmental inquiry, investigation, Proceeding, or other similar action, or has engaged in any conduct, that could reasonably be expected to result in debarment, suspension, or exclusion. (b) Except as Each of the Company Entities have, maintain and are operating in material compliance with all FDA License, and all such FDA Licenses are valid, subsisting, and in full force and effect, except where the failure to have, maintain or operate in material compliance with the FDA Licenses has not had, and would not reasonably be expected to have, individually or in the aggregate, a Holdings Material Adverse Effect, neither Holdings nor its current or former Subsidiaries nor, to the Knowledge of Holdings, any . Each of the owners, managers, officers, directors, employees or contractors Company Entities have fulfilled and performed all of Holdings or any of its Subsidiaries or any Holdings Healthcare Professional have been since January 1, 2013 through the date hereof: (i) convicted of, charged with or, to the Knowledge of Holdings, investigated by a Governmental Entity for any violation of any Laws or other misconduct related to any Governmental Program, (ii) convicted of, charged with or, to the Knowledge of Holdings, investigated by a Governmental Entity for a violation of any Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances related to the business or operations of Holdings or any of its Subsidiaries, (iii) excluded, suspended or debarred from, or otherwise ineligible to participate in, any Governmental Program, nor, to the Knowledge of Holdings, is any such exclusion, suspension or bar pending or threatened, or (iv) subject to any Order their material obligations with respect to the business FDA Licenses, and no event has occurred which allows, or operations with notice or lapse of Holdings time or both, would allow revocation or termination thereof or results in any other material impairment of its Subsidiariesthe rights of the holder of any FDA License, except where the failure to so fulfill or perform, or the occurrence of such event, would not result in a Material Adverse Effect. Each of the Company Entities have operated and currently are in compliance in all material respects with applicable Laws administered or enforced by the FDA and comparable Governmental Authorities, except where the failure to so comply would not result in a Material Adverse Effect. No Company Entity has received, in the past three (3) years, written notice of any pending or threatened Action (other than FDA or other Governmental Authority audits) from the FDA, any Governmental Authority, any qui-tam relator or applicable foreign Governmental Authority alleging that any operation or activity of a Company Entity is in material violation of any applicable Healthcare Law which violation would reasonably be expected to have a material and adverse impact on the Company Entities, taken as a whole. (c) To the Knowledge of Holdings and except where such noncompliance, individually or in the aggregate, Except as has not had and would not reasonably be expected to have, a Holdings Material Adverse Effect, each of the Persons performing clinical or professional healthcare services, including without limitation all physicians, mid-level providers (e.g., nurse practitioners, physician assistants, certified-registered nurse anesthetists), nurses paramedics, emergency medical technicians, or any other clinical staff on behalf of Holdings or its Subsidiaries, whether as an employee or independent contractor (each, a “Holdings Healthcare Professional” and collectively, the “Holdings Healthcare Professionals”): (i) has maintained and currently holds, in good standing, all Permits required by any applicable Law or Governmental Entity to perform the services in the states that such Holdings Healthcare Professional is practicing or performing professional services on behalf of Holdings or any of its Subsidiaries; and (ii) to the extent required, has been granted and continues to hold requisite staff privileges at, and is currently, and since January 1, 2013 has been, in good standing with, each of the hospitals and other healthcare facilities at or for which such Holdings Healthcare Professional performs medical services on behalf of Holdings or its Subsidiaries. To the Knowledge of Holdings, each Holdings Healthcare Professional has been and is in compliance with the terms and conditions of such Permits, except where such noncompliance would not, individually or in the aggregate, have a Holdings Material Adverse Effect. To , all applications, notifications, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the Knowledge of Holdingsbasis for or submitted in connection with any and all requests for a FDA License from the FDA or other Governmental Authority relating to the Company Entities, their business and products, when submitted to the FDA or other Governmental Authority were true, complete and correct as of the date hereofof submission and any necessary or required updates, neither Holdings nor any of its Subsidiaries has received written notice that any Holdings Healthcare Professional is under investigation bychanges, corrections or modification to such applications, submissions, information and data have been submitted to the subject of a self-disclosure to, FDA or is not in good standing with, any other Governmental Program or Governmental Entity, except where an unfavorable decision, ruling or finding of any such investigation or disclosure would not, individually or in the aggregate, have a Holdings Material Adverse Effect. With respect to Holdings Healthcare Professionals engaged on an independent contractor basis, Holdings or its Subsidiary has insured and insures, and maintains a certificate of insurance from each Holdings Healthcare Professional evidencing, that such Holdings Healthcare Professionals have in place malpractice insurance, except where such failure to maintain such insurance would not, individually or in the aggregate, have a Holdings Material Adverse EffectAuthority. (d) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Holdings Material Adverse Effect, during the past three (i3) Holdings and its Subsidiaries are each qualified for participation withyears, no Company Entity has had any product or manufacturing site (whether owned by a Company Entity, or currently participates witha contract manufacturer) for their products subject to a Governmental Authority (including FDA) shutdown or import or export prohibition, all nor received any FDA Form 483 or other Governmental Programs and Private Programs from which such entity seeks Authority notice of inspectional observations, “warning letters,” “untitled letters” or receives reimbursement for items requests or services, (ii) requirements to make changes to the billing practices of Holdings and its Subsidiaries to all customers, private individuals or patients, Governmental Programs and Private Programs have been and are in material compliance with applicable Health Care Laws, the HCPCS code set, and rules of applicable Governmental Programs, and (iii) neither Holdings nor any of its Subsidiaries has (a) billed, received or failed, whether on its behalf or on behalf of another Person, to timely return any material payment or reimbursement in excess of amounts allowed by applicable Health Care Lawsproducts, or similar correspondence or notice from the FDA or other Governmental Authority alleging or asserting noncompliance with any applicable Law, License or such requests or requirements of a Governmental Authority. (be) any material outstanding overpayments, refunds or Liability due to any Governmental Program or Governmental Entity. Except to the extent qualifying as ordinary course has not had and except as would not reasonably be expected to have, individually or in the aggregate, a Holdings Material Adverse Effect, (i) during the past three (3) years, there have been no (A) Safety Notices with respect to the products of any Company Entity or (B) complaints from a Governmental Authority with respect to such products that are currently unresolved and (ii) there are no pending appeals, adjustments, investigations, inquires, challenges, Actions or notices of intent facts that would be reasonably likely to audit or investigate by any Governmental Program or Governmental Entity result in (A) a Safety Notice with respect to enrollment eligibilitysuch products, compliance with conditions (B) a change in labeling of participation or paymentany such products, or claims, reports (C) a termination or other submissions by Holdings suspension of marketing or testing of any of its Subsidiaries. (e) Neither Holdings, nor any of its Subsidiaries has made since January 1, 2013, or is in the process of making, any voluntary self-disclosure to any Governmental Program or Governmental Entity, including without limitation any voluntary self-disclosures to the Centers for Medicare & Medicaid Services pursuant to the Medicare self-referral disclosure protocol or to the Office of the Inspector General pursuant to its self-disclosure protocol, or to any United States Attorney. To the Knowledge of Holdings, none of Holdings, its Subsidiaries or any of its Holdings Healthcare Professionals are mentioned in any voluntary self-disclosure made to any Governmental Entity by any healthcare facility or any other Personsuch products. (f) None of Holdings, its Subsidiaries or, Except as has not had and would not reasonably be expected to the Knowledge of Holdings, any Holdings Healthcare Professional is a party to, or bound by, any Order, corporate integrity agreement, deferred prosecution agreement, settlement agreement or other written agreement with any Governmental Entity concerning compliance with Health Care Laws thathave, individually or in the aggregate, have a Holdings Material Adverse Effect, (i) the clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by a Company Entity or in which any Company Entity, or any of their products or product candidates have participated were, and if still pending are, being conducted in accordance with standard medical and scientific research procedures and all applicable Laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 812 and (ii) no investigational device exemption filed by or on behalf of a Company Entity with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Governmental Authority has commenced, or, to the Company’s Knowledge threatened to commence, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of a Company Entity. (g) Holdings No Company Entity is the subject of any pending or, to the Company’s Knowledge, threatened investigation in respect of any Company Entity or their products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and its Subsidiaries have instituted Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and operate in accordance with a compliance plan which is consistent with guidance any amendments thereto (the “FDA Application Integrity Policy”). During the past three (3) years, no Company Entity nor any of their officers, employees or agents (within the meaning of the Office applicable Law) has been convicted of Inspector General any crime or engaged in any conduct that could reasonably be expected to result in a debarment, suspension or exclusion under (i) 21 U.S.C. Section 335a or (ii) any similar Law. As of the United States Department date hereof, no Actions that would reasonably be expected to result in such a debarment or exclusion are pending or, to the Company’s knowledge, threatened against any Company Entity, or any of Health & Human Servicestheir officers, employees or agents. No Company Entity nor, to the Company’s knowledge, any of its officers, employees, contractors, or agents has as (i) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority; (ii) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Authority; or (iii) committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for FDA to invoke the FDA Application Integrity Policy or for any similar Governmental Authority to invoke a similar policy. (h) None As of Holdings and its Subsidiaries has received notice of and, to the Knowledge of Holdings, there is and has been no individual complaint, pending or threatened litigation, legal proceeding (in law or in equity) or governmental or administrative investigation, settlement or penalty with respect to Holdings or any of its Subsidiaries or their respective Workforces (as defined under HIPAA) uses or disclosures of, or security practices regarding, individually identifiable health information, uses or disclosures of, or security practices regarding, individually identifiable health information, in each case that would be material to Holdings and its Subsidiaries, taken as a whole. To the Knowledge of Holdingsdate hereof, no Breach (as defined at 45 C.F.R. § 164.402) has occurred with respect to Company product or service is reimbursable by any unsecured PHI maintained by or for Holdings or any of its Subsidiaries that is subject to the notification requirements of 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b). To the Knowledge of Holdings, any Security Incidents (as defined at 45 C.F.R. § 164.304) involving unsecured PHI maintained by or for Holdings or any of its Subsidiaries have been Unsuccessful Security Incidents or non-material Security Incidents. None of Holdings and its Subsidiaries has notified the media or any Governmental Authority of any Breach as required by 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b), and none of Holdings and its Subsidiaries is currently planning to conduct any such notification or is investigating whether any such notification to the media or any Governmental Authority is required. Each of Holdings and its Subsidiaries has in place, and has complied and is in compliance with, written policies to protect the security and privacy of PHI. Each of Holdings and its Subsidiaries has the right pursuant to its contracts and its privacy and security policies to use and disclose PHI for the purposes for which such information is and has been used and disclosed. Neither the execution, delivery or performance of this Agreement, nor the consummation of any of the transactions contemplated by this Agreementfederal health care program, including any transfer of PHI resulting from such transactionsbut not limited to, will violate any policies of Holdings Medicare, Medicaid or its Subsidiaries or any privacy agreements to which Holdings or its Subsidiaries are a party as such policies or privacy agreements currently exist or as existed at any time during which any of such PHI was collected or obtainedthe Children’s Health Insurance Program.

Healthcare Compliance Matters. (i) Holdings Boat and each of its Subsidiaries are in compliance with and since January 1, 2013 2015 have not violated any been in compliance with all Health Care Law Laws applicable to Holdings Boat or any of its Subsidiaries or any items or services provided by or assets owned or used by any of them (except for such past noncompliance as has been remedied and imposes no continuing obligations or costs on Holdings or its Subsidiaries), and (ii) neither Holdings Boat nor any of its Subsidiaries has received any written communication or has been subject to any Proceeding (other than routine FDA inspections) since January 1, 2013 2015 from a Governmental Entity alleging that Holdings alleges that Boat or any of its Subsidiaries is or was not, or may not be, in compliance with any Health Care Law, except in the case of clauses (i) and (ii) where any actual or alleged non-compliance, individually or in the aggregate, has not had and would not reasonably be expected to have, a Holdings Boat Material Adverse Effect. Neither Holdings nor, to the Knowledge of Holdings, Boat nor any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity. Additionally, none of HoldingsBoat, its Subsidiaries or any of its respective employees, officers or directors or any Holdings Healthcare Professional has been excluded, suspended or debarred from participation in any U.S. state or federal health care program or, to the Knowledge of HoldingsBoat, has been convicted of any crime or is subject to a governmental inquiry, investigation, Proceeding, or other similar action, or has engaged in any conduct, that could reasonably be expected to result in debarment, suspension, or exclusion. (b) Except as Boat and each of its Subsidiaries have, maintain and are operating in material compliance with all Health Care Permits, and all such Health Care Permits are valid, subsisting, and in full force and effect, except where the failure to have, maintain or operate in compliance with the Health Care Permits has not had, and would not reasonably be expected to have, individually or in the aggregate, a Holdings Boat Material Adverse Effect, neither Holdings nor its current or former Subsidiaries nor, to the Knowledge of Holdings, any of the owners, managers, officers, directors, employees or contractors of Holdings or any . Boat and each of its Subsidiaries have fulfilled and performed all of their obligations with respect to the Health Care Permits, and no event has occurred which allows, or with notice or lapse of time or both, would allow revocation or termination thereof or results in any Holdings Healthcare Professional have been since January 1other material impairment of the rights of the holder of any Health Care Permit, 2013 through except where the date hereof: (i) convicted offailure to so fulfill or perform, charged with or the occurrence of such event, would not result in a Boat Material Adverse Effect. There is no Proceeding pending or, to the Knowledge of HoldingsBoat, investigated by a Governmental Entity for any violation threatened in writing that could result in the suspension, termination, revocation, cancellation, limitation or impairment of any Laws or such Health Care Permit other misconduct related than those that have not had and would not reasonably expected to any Governmental Program, (ii) convicted of, charged with or, to the Knowledge of Holdings, investigated by a Governmental Entity for a violation of any Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances related to the business or operations of Holdings or any of its Subsidiaries, (iii) excluded, suspended or debarred from, or otherwise ineligible to participate in, any Governmental Program, nor, to the Knowledge of Holdings, is any such exclusion, suspension or bar pending or threatened, or (iv) subject to any Order with respect to the business or operations of Holdings or any of its Subsidiaries. (c) To the Knowledge of Holdings and except where such noncompliancehave, individually or in the aggregate, a Boat Material Adverse Effect. (c) Except as has not had and would not reasonably be expected to have, a Holdings Material Adverse Effect, each of the Persons performing clinical or professional healthcare services, including without limitation all physicians, mid-level providers (e.g., nurse practitioners, physician assistants, certified-registered nurse anesthetists), nurses paramedics, emergency medical technicians, or any other clinical staff on behalf of Holdings or its Subsidiaries, whether as an employee or independent contractor (each, a “Holdings Healthcare Professional” and collectively, the “Holdings Healthcare Professionals”): (i) has maintained and currently holds, in good standing, all Permits required by any applicable Law or Governmental Entity to perform the services in the states that such Holdings Healthcare Professional is practicing or performing professional services on behalf of Holdings or any of its Subsidiaries; and (ii) to the extent required, has been granted and continues to hold requisite staff privileges at, and is currently, and since January 1, 2013 has been, in good standing with, each of the hospitals and other healthcare facilities at or for which such Holdings Healthcare Professional performs medical services on behalf of Holdings or its Subsidiaries. To the Knowledge of Holdings, each Holdings Healthcare Professional has been and is in compliance with the terms and conditions of such Permits, except where such noncompliance would not, individually or in the aggregate, have a Holdings Boat Material Adverse Effect. To , all applications, notifications, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the Knowledge basis for or submitted in connection with any and all requests for a Health Care Permit relating to Boat and each of Holdingsits Subsidiaries, their business and products and product candidates, when submitted to the FDA, DEA or other Governmental Entity were true, complete and correct as of the date hereofof submission and any necessary or required updates, neither Holdings nor any of its Subsidiaries has received written notice that any Holdings Healthcare Professional is under investigation bychanges, corrections or modification to such applications, submissions, information and data have been submitted to the subject of a self-disclosure toFDA, DEA or is not in good standing with, any Governmental Program or other Governmental Entity, except where an unfavorable decision, ruling or finding of any such investigation or disclosure would not, individually or in the aggregate, have a Holdings Material Adverse Effect. With respect to Holdings Healthcare Professionals engaged on an independent contractor basis, Holdings or its Subsidiary has insured and insures, and maintains a certificate of insurance from each Holdings Healthcare Professional evidencing, that such Holdings Healthcare Professionals have in place malpractice insurance, except where such failure to maintain such insurance would not, individually or in the aggregate, have a Holdings Material Adverse Effect. (d) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Holdings Boat Material Adverse Effect, (i) Holdings since January 1, 2015, Boat and each of its Subsidiaries are each qualified for participation withhave not had any product, product candidate or manufacturing site (whether owned by Boat or its Subsidiary(ies), or currently participates witha contract manufacturer for their products and product candidates) subject to a Governmental Entity (including FDA or DEA) shutdown or import or export prohibition, all nor received any FDA Form 483 or other Governmental Programs and Private Programs Entity notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make changes to a product or product candidate, or similar correspondence or written notice from which such entity seeks the FDA, DEA or receives reimbursement for items other Governmental Entity alleging or services, (ii) the billing practices of Holdings and its Subsidiaries to all customers, private individuals or patients, Governmental Programs and Private Programs have been and are in material compliance asserting noncompliance with any applicable Health Care LawsLaw, the HCPCS code set, and rules of applicable Governmental Programs, and (iii) neither Holdings nor any of its Subsidiaries has (a) billed, received or failed, whether on its behalf or on behalf of another Person, to timely return any material payment or reimbursement in excess of amounts allowed by applicable Health Care LawsPermit or such requests or requirements of a Governmental Entity. (e) To the Knowledge of Boat, there are no facts or circumstances that would be reasonably likely to result in (A) a change in the marketing classification or a material change in the labeling of any product or product candidate or (bB) a termination or suspension of any material outstanding overpayments, refunds Health Care Permits for such products or Liability due to any Governmental Program or Governmental Entity. product candidates. (f) Except to the extent qualifying as ordinary course has not had and except as would not reasonably be expected to have, individually or in the aggregate, a Holdings Boat Material Adverse Effect, there are no pending appeals(i) the clinical, adjustmentspre-clinical and other studies and tests conducted by or on behalf of or sponsored by Boat or its Subsidiaries or in which Boat or its Subsidiaries, investigations, inquires, challenges, Actions or notices of intent to audit or investigate by any Governmental Program or Governmental Entity with respect to enrollment eligibility, compliance with conditions of participation or payment, or claims, reports or other submissions by Holdings or any of their products and product candidates have participated were, and if still pending are, being conducted in accordance with standard medical and scientific research procedures and all applicable Laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its Subsidiaries. applicable implementing regulations and (eii) Neither Holdingsno investigational new drug application filed by or on behalf of Boat or its Subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any of its Subsidiaries has made since January 1, 2013, or is in the process of making, any voluntary self-disclosure to any Governmental Program or Governmental Entity, including without limitation any voluntary self-disclosures to the Centers for Medicare & Medicaid Services pursuant to the Medicare self-referral disclosure protocol or to the Office of the Inspector General pursuant to its self-disclosure protocol, or to any United States Attorney. To the Knowledge of Holdings, none of Holdings, its Subsidiaries or any of its Holdings Healthcare Professionals are mentioned in any voluntary self-disclosure made to any applicable foreign Governmental Entity by any healthcare facility or any other Person. (f) None of Holdingshas commenced, its Subsidiaries or, to the Knowledge of HoldingsBoat, threatened to commence, any Holdings Healthcare Professional is action to place a party toclinical hold order on, or bound byotherwise terminate, delay or suspend, any Order, corporate integrity agreement, deferred prosecution agreement, settlement agreement proposed or other written agreement with any Governmental Entity concerning compliance with Health Care Laws that, individually ongoing clinical investigation conducted or in the aggregate, have a Holdings Material Adverse Effectproposed to be conducted by or on behalf of Boat and its Subsidiaries. (g) Holdings and Neither Boat nor any of its Subsidiaries have instituted and operate in accordance with a compliance plan which is consistent with guidance the subject of the Office of Inspector General of the United States Department of Health & Human Services. (h) None of Holdings and its Subsidiaries has received notice of andany pending or, to the Knowledge of HoldingsBoat, there is and has been no individual complaintthreatened investigation in respect of Boat, pending or threatened litigation, legal proceeding (in law or in equity) or governmental or administrative investigation, settlement or penalty with respect to Holdings or any of its Subsidiaries or their respective Workforces products and product candidates, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (as defined under HIPAASeptember 10, 1991) uses or disclosures of, or security practices regarding, individually identifiable health information, uses or disclosures of, or security practices regarding, individually identifiable health information, in each case that would be material and any amendments thereto. Boat has provided Island accurate and complete copies of all Health Care Permits and correspondence with any Governmental Entity related to Holdings all products and product candidates of Boat and its Subsidiaries, taken as a whole. To the Knowledge of Holdings, no Breach (as defined at 45 C.F.R. § 164.402) has occurred with respect to any unsecured PHI maintained by or for Holdings or any of its Subsidiaries that is subject to the notification requirements of 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b). To the Knowledge of Holdings, any Security Incidents (as defined at 45 C.F.R. § 164.304) involving unsecured PHI maintained by or for Holdings or any of its Subsidiaries have been Unsuccessful Security Incidents or non-material Security Incidents. None of Holdings and its Subsidiaries has notified the media or any Governmental Authority of any Breach as required by 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b), and none of Holdings and its Subsidiaries is currently planning to conduct any such notification or is investigating whether any such notification to the media or any Governmental Authority is required. Each of Holdings and its Subsidiaries has in place, and has complied and is in compliance with, written policies to protect the security and privacy of PHI. Each of Holdings and its Subsidiaries has the right pursuant to its contracts and its privacy and security policies to use and disclose PHI for the purposes for which such information is and has been used and disclosed. Neither the execution, delivery or performance of this Agreement, nor the consummation of any of the transactions contemplated by this Agreement, including any transfer of PHI resulting from such transactions, will violate any policies of Holdings or its Subsidiaries or any privacy agreements to which Holdings or its Subsidiaries are a party as such policies or privacy agreements currently exist or as existed at any time during which any of such PHI was collected or obtained.

Healthcare Compliance Matters. (ia) Holdings Each of Laguna and Orca, as applicable, and each of its Subsidiaries are Subsidiaries, (i) is in compliance with and since January 1, 2013 have not violated any 2019 has been in compliance with all Health Care Law Laws applicable to Holdings it or any of its Subsidiaries or any items or services provided by or assets owned or used by any of them (except for such past noncompliance as has been remedied and imposes no continuing obligations or costs on Holdings or its Subsidiaries)it, and (ii) neither Holdings Laguna nor Orca, as applicable, nor any of its Subsidiaries has received any written communication since January 1, 2013 2019 from a Governmental Entity alleging that Holdings remains uncured or unresolved and that alleges that such party or any of its Subsidiaries is or was not, or may not be, in compliance with any Health Care Law, except in the case of clauses (i) and (ii) where any actual or alleged non-compliance, individually or in the aggregate, has not had and would not reasonably be expected to have, a Holdings Material Adverse Effect. Neither Holdings Laguna nor Orca, as applicable, nor, to the Knowledge knowledge of Holdingssuch party, any of its Subsidiaries is a party to or has any ongoing reporting obligations pursuant to or under any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity. Additionally, since January 1, 2019, none of HoldingsLaguna or Orca, as applicable, or any of its Subsidiaries or any of its respective employees, officers or officers, directors or any Holdings Healthcare Professional or, to the knowledge of such party, agents (A) has been excluded, suspended or debarred from participation in any U.S. state or federal health care program orprogram, (B) to the Knowledge knowledge of Holdingssuch party, has been convicted of any crime or is subject to a governmental inquiry, investigation, Proceeding, or other similar action, or (C) to the knowledge of such party, has engaged in any conduct, that could reasonably be expected to result in debarment, suspension, or exclusion, except for any exclusion, suspension, debarment, conviction or conduct that, individually or in the aggregate has not had and would not reasonably be expected to have a Material Adverse Effect. (b) Except Each of Laguna and Orca, as applicable, and each of its Subsidiaries has, maintains and is operating in material compliance with, and all of its products are designed, manufactured, imported, exported, processed, developed, labeled, stored, tested and marketed in compliance with, all Permits of the United States Food and Drug Administration (“FDA”) and comparable Governmental Entities which are required for the conduct of its business as currently conducted (collectively, the “FDA Permits”), and all such FDA Permits are valid, subsisting, and in full force and effect, except where the failure to have, maintain or operate in material compliance with the FDA Permits has not had, and would not reasonably be expected to have, individually or in the aggregate, a Holdings Material Adverse Effect. Since January 1, neither Holdings nor 2019, each of Laguna and Orca, as applicable, and each of its current or former Subsidiaries nor, have fulfilled and performed all of their material obligations with respect to the Knowledge FDA Permits, and no event has occurred which allows, or with notice or lapse of Holdingstime or both, would allow revocation or termination thereof or results in any other material impairment of the rights of the holder of any FDA Permit, except where the failure to so fulfill or perform, or the occurrence of such event, would not result in a Material Adverse Effect. Each of Laguna and Orca, as applicable, and each of its Subsidiaries have operated and currently are in compliance in all material respects with applicable Laws administered or enforced by the FDA and comparable Governmental Entities, except where the failure to so comply would not result in a Material Adverse Effect. Each of Laguna and Orca, as applicable, and each of its Subsidiaries has not received, since January 1, 2019, written notice of any pending or threatened Proceeding (other than FDA audits) from the FDA, any Governmental Entity, any qui-tam relator or applicable foreign Governmental Entity alleging that any operation or activity of the owners, managers, officers, directors, employees or contractors of Holdings such party or any of its Subsidiaries or any Holdings Healthcare Professional have been since January 1, 2013 through the date hereof: (i) convicted of, charged with or, to the Knowledge of Holdings, investigated by a Governmental Entity for any is in material violation of any Laws or other misconduct related applicable Health Care Law which violation would reasonably be expected to any Governmental Program, (ii) convicted of, charged with or, to the Knowledge of Holdings, investigated by have a Governmental Entity for a violation of any Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances related to the business or operations of Holdings or any of material and adverse impact on such party and its Subsidiaries, (iii) excluded, suspended or debarred from, or otherwise ineligible to participate in, any Governmental Program, nor, to the Knowledge of Holdings, is any such exclusion, suspension or bar pending or threatened, or (iv) subject to any Order with respect to the business or operations of Holdings or any of its Subsidiariestaken as a whole. (c) To the Knowledge of Holdings and except where such noncompliance, individually or in the aggregate, Except as has not had and would not reasonably be expected to have, a Holdings Material Adverse Effect, each of the Persons performing clinical or professional healthcare services, including without limitation all physicians, mid-level providers (e.g., nurse practitioners, physician assistants, certified-registered nurse anesthetists), nurses paramedics, emergency medical technicians, or any other clinical staff on behalf of Holdings or its Subsidiaries, whether as an employee or independent contractor (each, a “Holdings Healthcare Professional” and collectively, the “Holdings Healthcare Professionals”): (i) has maintained and currently holds, in good standing, all Permits required by any applicable Law or Governmental Entity to perform the services in the states that such Holdings Healthcare Professional is practicing or performing professional services on behalf of Holdings or any of its Subsidiaries; and (ii) to the extent required, has been granted and continues to hold requisite staff privileges at, and is currently, and since January 1, 2013 has been, in good standing with, each of the hospitals and other healthcare facilities at or for which such Holdings Healthcare Professional performs medical services on behalf of Holdings or its Subsidiaries. To the Knowledge of Holdings, each Holdings Healthcare Professional has been and is in compliance with the terms and conditions of such Permits, except where such noncompliance would not, individually or in the aggregate, have a Holdings Material Adverse Effect. To , since January 1, 2019, all applications, notifications, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the Knowledge basis for or submitted in connection with any and all requests for a FDA Permit from the FDA or other Governmental Entity relating to Laguna or Orca, as applicable, and each of Holdingsits Subsidiaries, businesses and products, when submitted to the FDA or other Governmental Entity were true, complete and correct as of the date hereofof submission and any necessary or required updates, neither Holdings nor any of its Subsidiaries has received written notice that any Holdings Healthcare Professional is under investigation bychanges, corrections or modification to such applications, submissions, information and data have been submitted to the subject of a self-disclosure to, FDA or is not in good standing with, any Governmental Program or other Governmental Entity, except where an unfavorable decision, ruling or finding of any such investigation or disclosure would not, individually or in the aggregate, have a Holdings Material Adverse Effect. With respect to Holdings Healthcare Professionals engaged on an independent contractor basis, Holdings or its Subsidiary has insured and insures, and maintains a certificate of insurance from each Holdings Healthcare Professional evidencing, that such Holdings Healthcare Professionals have in place malpractice insurance, except where such failure to maintain such insurance would not, individually or in the aggregate, have a Holdings Material Adverse Effect. (d) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Holdings Material Adverse Effect, (i) Holdings since January 1, 2019, each of Laguna and its Subsidiaries are each qualified for participation withOrca, or currently participates with, all Governmental Programs and Private Programs from which such entity seeks or receives reimbursement for items or services, (ii) the billing practices of Holdings and its Subsidiaries to all customers, private individuals or patients, Governmental Programs and Private Programs have been and are in material compliance with applicable Health Care Laws, the HCPCS code setas applicable, and rules of applicable Governmental Programs, and (iii) neither Holdings nor any each of its Subsidiaries has not had any product or manufacturing site (a) billed, received whether owned by such party or failed, whether on its behalf or on behalf of another Person, to timely return any material payment or reimbursement in excess of amounts allowed by applicable Health Care LawsSubsidiary(s), or a contract manufacturer for its products) subject to a Governmental Entity (bincluding FDA) shutdown or import or export prohibition, nor received any material outstanding overpaymentsFDA Form 483 or other Governmental Entity notice of inspectional observations, refunds “warning letters,” “untitled letters” or Liability due requests or requirements to make changes to the products, or similar correspondence or notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any Governmental Program applicable Law, Permit or such requests or requirements of a Governmental Entity. Except to the extent qualifying as ordinary course and except as would not have, individually or in the aggregate, a Holdings Material Adverse Effect, there are no pending appeals, adjustments, investigations, inquires, challenges, Actions or notices of intent to audit or investigate by any Governmental Program or Governmental Entity with respect to enrollment eligibility, compliance with conditions of participation or payment, or claims, reports or other submissions by Holdings or any of its Subsidiaries. (e) Section 4.25(e) of the Laguna Disclosure Letter or Orca Disclosure Letter, as applicable, sets forth a list of (i) all material recalls, removals, field notifications, field corrections, market withdrawals or replacements, corrective actions, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance (collectively, “Safety Notices”) with respect to the products of Laguna or Orca, as applicable, and its respective Subsidiaries, respectively, since January 1, 2019 and (ii) the date on which any such Safety Notice was resolved or closed (as applicable). To the knowledge of Laguna or Orca, as applicable, (A) since January 1, 2019, there have been no material complaints with respect to its products that are currently unresolved, (B) there are no facts that would be reasonably likely to result in (x) a material Safety Notice with respect to its products or offerings, (y) a material change in marketing classification or labeling of any such products, or (z) a termination or suspension of marketing or testing of any of its products or offerings. (f) Neither HoldingsLaguna nor Orca, as applicable, nor any of its Subsidiaries has made since January 1is the subject of any pending or, 2013, or is in the process of making, any voluntary self-disclosure to any Governmental Program or Governmental Entity, including without limitation any voluntary self-disclosures to the Centers for Medicare & Medicaid Services pursuant to the Medicare self-referral disclosure protocol knowledge of Laguna or to the Office Orca, as applicable, threatened investigation in respect of the Inspector General pursuant to its self-disclosure protocol, or to any United States Attorney. To the Knowledge of Holdings, none of Holdingssuch party, its Subsidiaries or its products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Since January 1, 2019, neither Laguna nor Orca, as applicable, nor, to the knowledge of such party, any of its Holdings Healthcare Professionals are mentioned officers, employees or agents (within the meaning of the applicable Law) has been convicted of any crime or engaged in any voluntary self-disclosure made conduct that could result in a material debarment or exclusion under (i) 21 U.S.C. Section 335a or (ii) any similar Law. As of the date hereof, no Proceedings that would reasonably be expected to any Governmental Entity by any healthcare facility result in such a debarment or any other Person. (f) None of Holdings, its Subsidiaries exclusion are pending or, to the Knowledge knowledge of HoldingsLaguna or Orca, any Holdings Healthcare Professional is a party toas applicable, threatened against such party, its Subsidiaries, or bound byany of their respective officers, any Order, corporate integrity agreement, deferred prosecution agreement, settlement agreement employees or other written agreement with any Governmental Entity concerning compliance with Health Care Laws that, individually or in the aggregate, have a Holdings Material Adverse Effectagents. (g) Holdings Since January 1, 2019, all studies, tests and preclinical and clinical studies being conducted by or on behalf of or sponsored by Laguna or Orca, as applicable, or its Subsidiaries, or in which Laguna or Orca, as applicable, or its Subsidiaries has participated, were and, if still pending, are being conducted in material compliance with applicable Laws, including, without limitation, the Health Care Laws including 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812. Laguna and Orca have made all such filings and obtained all such approvals, authorizations or exemptions as may be required by the FDA or any other Healthcare Regulatory Authority for the conduct of such tests or studies. Since January 1, 2019, each of Laguna or Orca, as applicable, and its Subsidiaries, has not received any written notices, correspondence or other communication from any institutional review board or ethics committee, the FDA or any other Governmental Entity, recommending or requiring the termination, suspension, or material modification of any ongoing studies or tests conducted or proposed to be conduct by, or on behalf of, or supervised by, such party or its Subsidiaries, or in which the products or investigational products of such party or its Subsidiaries have instituted and operate in accordance with a compliance plan which is consistent with guidance of the Office of Inspector General of the United States Department of Health & Human Servicesparticipated. (h) None As used in this Agreement, “Health Care Laws” means all applicable federal, state, local and foreign healthcare Laws, including, without limitation, (i) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.); (ii) the Controlled Substances Act (21 U.S.C. § 801 et seq.); (iii) the Public Health Service Act (42 U.S.C. § 201 et seq.); (iv) all applicable federal, state, local and all applicable foreign health care related fraud and abuse, false claims, and anti-kickback laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the U.S. Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h) and similar gift and disclosure Laws, the U.S. Civil False Claims Act (31 U.S.C. § 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. §§ 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of Holdings 1996 (“HIPAA”) (42 U.S.C. § 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and its Subsidiaries has received notice of andClinical Health Act (42 U.S.C. § 17921 et seq.), Laws pertaining to privacy, data protection and information security, and the regulations promulgated pursuant to such statutes; (v) state Laws relating to the Knowledge manufacture, sale and distribution of Holdings, there is medical products; (vi) Medicare (Title XVIII of the Social Security Act) and has been no individual complaint, pending or threatened litigation, legal proceeding (in law or in equityvii) or governmental or administrative investigation, settlement or penalty with respect to Holdings or Medicaid (Title XIX of the Social Security Act); (viii) any of its Subsidiaries or their respective Workforces (as defined under HIPAA) uses or disclosures of, or security practices regarding, individually identifiable health information, uses or disclosures of, or security practices regarding, individually identifiable health information, in each case that would be material to Holdings and its Subsidiaries, taken as a whole. To the Knowledge of Holdings, no Breach (as defined at 45 C.F.R. § 164.402) has occurred with respect to any unsecured PHI maintained by or for Holdings or any of its Subsidiaries that is subject to the notification requirements of 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b). To the Knowledge of Holdings, any Security Incidents (as defined at 45 C.F.R. § 164.304) involving unsecured PHI maintained by or for Holdings or any of its Subsidiaries have been Unsuccessful Security Incidents state or non-material Security Incidents. None of Holdings U.S. counterpart thereof; and its Subsidiaries has notified (ix) the media or any Governmental Authority of any Breach as required by 45 C.F.R. Part 164, Subpart D § 164.406 or 164.408(b), and none of Holdings and its Subsidiaries is currently planning to conduct any such notification or is investigating whether any such notification to the media or any Governmental Authority is required. Each of Holdings and its Subsidiaries has in place, and has complied and is in compliance with, written policies to protect the security and privacy of PHI. Each of Holdings and its Subsidiaries has the right regulations promulgated pursuant to its contracts and its privacy and security policies such laws identified in subparts (i) to use and disclose PHI for the purposes for which such information is and has been used and disclosed. Neither the execution, delivery or performance of this Agreement, nor the consummation of any of the transactions contemplated by this Agreement, including any transfer of PHI resulting from such transactions, will violate any policies of Holdings or its Subsidiaries or any privacy agreements to which Holdings or its Subsidiaries are a party as such policies or privacy agreements currently exist or as existed at any time during which any of such PHI was collected or obtained(viii).