Common use of Health Care Regulatory Matters Clause in Contracts

Health Care Regulatory Matters. (a) As of the Effective Date, each Loan Party is in compliance with, and is conducting and, for the six years preceding the Effective Date, has conducted its respective business and operations in compliance with, the requirements of all Health Care Laws and Public Health Laws, except for such non-compliance which, individually or in the aggregate, is not reasonably likely to result in a Material Adverse Effect. (b) The Borrower and its Subsidiaries have all Registrations issued or supervised by any Public Health Regulatory Agency or other Governmental Authority required to conduct their respective businesses as currently conducted, except where the failure to have all such Registrations could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. Each of such Registrations is valid and subsisting in full force and effect, except where the failure to be so could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. To the knowledge of the Borrower and its Subsidiaries, none of any Public Health Regulatory Agency or any other Governmental Authority is considering limiting, suspending, or revoking such party’s submission to any Public Health Regulatory Agency or any other Governmental Authority; provided, that, in each case of the foregoing clauses, where such false or misleading information or omissions could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities and excluding any material limitations or omissions that were clearly disclosed to the recipient of a listed item. The Borrower and its Subsidiaries have not failed to fulfill and perform their obligations which are due under each Registration held by or licensed to them, and no event has occurred or condition or state of facts exists which would constitute a breach or default under any such Registration, in each case that would reasonably be expected to cause Material Regulatory Liabilities. To the knowledge of the Borrower and its Subsidiaries, any third party that is a manufacturer or contractor for the Borrower and its Subsidiaries is in compliance with all Registrations from any Public Health Regulatory Agency and any other Governmental Authority insofar as they pertain to the manufacture of product components or products or the analysis or generation of data for the Borrower and its Subsidiaries, except where the failure to so be in compliance would not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (c) All products developed, manufactured, tested, distributed, marketed, or sold by or on behalf of the Borrower and its Subsidiaries that are subject to the jurisdiction of any Public Health Regulatory Agency or any other Governmental Authority (x) have been and are being developed, tested, manufactured, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Law, including, without limitation and to the extent applicable, in material compliance with any pre-market notification or pre-market approval requirements, good manufacturing practices, quality system requirements, labeling requirements, advertising requirements, record keeping requirements and adverse event reporting requirements, and (y) have been and are being tested, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Law, except, in each case of clauses (x) and (y), where such noncompliance would not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (d) The Borrower and its Subsidiaries have not received and are not subject to any administrative or regulatory action, warning letter, notice of violation letter, or other similar written notice, complaint or inquiry made by any Public Health Regulatory Agency or any other Governmental Authority asserting that the development, testing, investigation, manufacture, distribution, marketing or sale of the products of any Borrower or any of its Subsidiaries is not in compliance with any applicable law, except those noncompliance that could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. To the extent applicable, (x) the Borrower and its Subsidiaries have made all notifications, submissions, and reports required by any such Governmental Authority, and (y) all such notifications, submissions and reports provided by the Borrower and its Subsidiaries were, to their knowledge, true, complete, and correct in all material respects as of the date of submission to any Public Health Regulatory Agency or any other Governmental Authority, except, where such failure to comply with (x) or (y) could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (e) No product of the Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, and, to the knowledge of the Borrower, there are no facts or circumstances reasonably likely to cause (x) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; (y) a material adverse change in the labeling of any such product; or (z) a termination, seizure or suspension of marketing of any such product, except, in each case, where such events could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any such product are pending or, to the knowledge the Borrower or its Subsidiaries, threatened against the Borrower and its Subsidiaries, except where such proceeding could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liability.

Health Care Regulatory Matters. (a) As of the Effective Date, each Loan Party is in compliance with, and is conducting and, for the six years preceding the Effective Date, has conducted its respective business and operations in compliance with, the requirements of all Health Care Laws and Public Health Laws, except for such non-compliance noncompliance which, individually or in the aggregate, is not reasonably likely to result in a Material Adverse Effect. (b) The Borrower and its Subsidiaries have all Registrations issued or supervised by any Public Health Regulatory Agency or other Governmental Authority required to conduct their respective businesses as currently conducted, except where the failure to have all such Registrations could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. Each of such Registrations is valid and subsisting in full force and effect, except where the failure to be so could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. To the knowledge of the Borrower and its Subsidiaries, none of any Public Health Regulatory Agency or any other Governmental Authority is considering limiting, suspending, or revoking such party’s submission to any Public Health Regulatory Agency or any other Governmental Authority; provided, that, in each case of the foregoing clauses, where such false or misleading information or omissions could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities and excluding any material limitations or omissions that were clearly disclosed to the recipient of a listed item. The Borrower and its Subsidiaries have not failed to fulfill and perform their obligations which are due under each Registration held by or licensed to them, and no event has occurred or condition or state of facts exists which would constitute a breach or default under any such Registration, in each case that would reasonably be expected to cause Material Regulatory Liabilities. To the knowledge of the Borrower and its Subsidiaries, any third party that is a manufacturer or contractor for the Borrower and its Subsidiaries is in compliance with all Registrations from any Public Health Regulatory Agency and any other Governmental Authority insofar as they pertain to the manufacture of product components or products or the analysis or generation of data for the Borrower and its Subsidiaries, except where the failure to so be in compliance would not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (c) All products developed, manufactured, tested, distributed, marketed, or sold by or on behalf of the Borrower and its Subsidiaries that are subject to the jurisdiction of any Public Health Regulatory Agency or any other Governmental Authority (x) have been and are being developed, tested, manufactured, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Law, including, without limitation and to the extent applicable, in material compliance with any pre-market notification or pre-market approval requirements, good manufacturing practices, quality system requirements, labeling requirements, advertising requirements, record keeping requirements and adverse event reporting requirements, and (y) have been and are being tested, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Law, except, in each case of clauses (x) and (y), where such noncompliance would not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (d) The Borrower and its Subsidiaries have not received and are not subject to any administrative or regulatory action, warning letter, notice of violation letter, or other similar written notice, complaint or inquiry made by any Public Health Regulatory Agency or any other Governmental Authority asserting that the development, testing, investigation, manufacture, distribution, marketing or sale of the products of any Borrower or any of its Subsidiaries is not in compliance with any applicable law, except those noncompliance that could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. To the extent applicable, (x) the Borrower and its Subsidiaries have made all notifications, submissions, and reports required by any such Governmental Authority, and (y) all such notifications, submissions and reports provided by the Borrower and its Subsidiaries were, to their knowledge, true, complete, and correct in all material respects as of the date of submission to any Public Health Regulatory Agency or any other Governmental Authority, except, where such failure to comply with (x) or (y) could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (e) No product of the Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, and, to the knowledge of the Borrower, there are no facts or circumstances reasonably likely to cause (x) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; (y) a material adverse change in the labeling of any such product; or (z) a termination, seizure or suspension of marketing of any such product, except, in each case, where such events could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any such product are pending or, to the knowledge the Borrower or its Subsidiaries, threatened against the Borrower and its Subsidiaries, except where such proceeding could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liability.

Health Care Regulatory Matters. (a) As Section 3.16(a) of the Effective Date, Fund II Disclosure Schedule sets forth a true and correct list of each Loan Party Health Care Facility. (b) Each Health Care Facility is being operated in compliance with, and is conducting and, for the six years preceding the Effective Date, has conducted its respective business and operations in compliance with, the requirements of all respects with all Health Care Laws and Public Health LawsLegal Requirements applicable thereto, except for such non-compliance which, individually or in the aggregate, is as would not reasonably likely be expected to result have a Company Material Adverse Effect. Neither Mayfair Village nor Mayfair Nursing Care has received written notice from a Governmental Authority that it is subject to any action, proceeding, suit, investigation or sanction by or on behalf of any Governmental Authority or any other Person brought pursuant to any Health Care Legal Requirement, nor, to the Knowledge of Fund II, has any such action, proceeding, suit, investigation or sanction been threatened. (c) Each of Mayfair Village and Mayfair Nursing Care is operating so as to comply in all respects with all applicable contractual obligations, billing policies, procedures, limitations and restrictions of any Health Care Program, except for such non-compliance as would not reasonably be expected to have a Company Material Adverse Effect. Each of Mayfair Village and Mayfair Nursing Care holds all the Health Care Permits necessary for the lawful conduct of its business, except where the failure to hold the same would not reasonably be expected to have a Company Material Adverse Effect. Each of Mayfair Village and Mayfair Nursing Care is in compliance with the terms of the Provider Agreements under which it is presently receiving payments, except for such non-compliance as would not reasonably be expected to have a Company Material Adverse Effect. (bd) The Borrower No Health Care Facility had any material deficiencies at level G or above on its most recent survey (standard or complaint) or has been cited with any Immediate Jeopardy or substandard quality of care deficiencies (as that term is defined in Part 488 of 42 C.F.R. and its Subsidiaries have all Registrations issued implementing policies and procedures), nor has any Health Care Facility been cited for any deficiency that would result in a denial of payment for new admissions, civil monetary penalty, termination, loss of Health Care Permits or supervised by any Public Health Regulatory Agency Provider Agreements, decertification or other Governmental Authority required debarment, with no opportunity to conduct their respective businesses as currently conductedcorrect prior to termination, for which an acceptable plan of correction has not been timely submitted, except where the failure to have all for such Registrations could not reasonably be expected todeficiencies, individually quality of care deficiencies, denials of payments for new admissions, civil monetary penalties, loss of Health Care Permits, Provider Agreements decertification or in the aggregate, result in Material Regulatory Liabilities. Each of such Registrations is valid and subsisting in full force and effect, except where the failure to be so could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. To the knowledge of the Borrower and its Subsidiaries, none of any Public Health Regulatory Agency or any other Governmental Authority is considering limiting, suspending, or revoking such party’s submission to any Public Health Regulatory Agency or any other Governmental Authority; provided, that, in each case of the foregoing clauses, where such false or misleading information or omissions could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities and excluding any material limitations or omissions that were clearly disclosed to the recipient of a listed item. The Borrower and its Subsidiaries have not failed to fulfill and perform their obligations which are due under each Registration held by or licensed to them, and no event has occurred or condition or state of facts exists which would constitute a breach or default under any such Registration, in each case that would reasonably be expected to cause Material Regulatory Liabilities. To the knowledge of the Borrower and its Subsidiaries, any third party that is a manufacturer or contractor for the Borrower and its Subsidiaries is in compliance with all Registrations from any Public Health Regulatory Agency and any other Governmental Authority insofar debarment as they pertain to the manufacture of product components or products or the analysis or generation of data for the Borrower and its Subsidiaries, except where the failure to so be in compliance would not reasonably be expected to, individually or in the aggregate, result in to have a Company Material Regulatory LiabilitiesAdverse Effect. (c) All products developed, manufactured, tested, distributed, marketed, or sold by or on behalf of the Borrower and its Subsidiaries that are subject to the jurisdiction of any Public Health Regulatory Agency or any other Governmental Authority (x) have been and are being developed, tested, manufactured, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Law, including, without limitation and to the extent applicable, in material compliance with any pre-market notification or pre-market approval requirements, good manufacturing practices, quality system requirements, labeling requirements, advertising requirements, record keeping requirements and adverse event reporting requirements, and (y) have been and are being tested, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Law, except, in each case of clauses (x) and (y), where such noncompliance would not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (d) The Borrower and its Subsidiaries have not received and are not subject to any administrative or regulatory action, warning letter, notice of violation letter, or other similar written notice, complaint or inquiry made by any Public Health Regulatory Agency or any other Governmental Authority asserting that the development, testing, investigation, manufacture, distribution, marketing or sale of the products of any Borrower or any of its Subsidiaries is not in compliance with any applicable law, except those noncompliance that could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. To the extent applicable, (x) the Borrower and its Subsidiaries have made all notifications, submissions, and reports required by any such Governmental Authority, and (y) all such notifications, submissions and reports provided by the Borrower and its Subsidiaries were, to their knowledge, true, complete, and correct in all material respects as of the date of submission to any Public Health Regulatory Agency or any other Governmental Authority, except, where such failure to comply with (x) or (y) could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (e) No product of the Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, and, to the knowledge of the Borrower, there are no facts or circumstances reasonably likely to cause (x) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; (y) a material adverse change in the labeling of any such product; or (z) a termination, seizure or suspension of marketing of any such product, except, in each case, where such events could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any such product are pending or, to the knowledge the Borrower or its Subsidiaries, threatened against the Borrower and its Subsidiaries, except where such proceeding could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liability.

Health Care Regulatory Matters. (a) As Except as disclosed on Schedule 5.19 and except where noncompliance does not and would not reasonably be expected to have a Material Adverse Effect on the condition (financial or otherwise), operations, assets, business, properties or prospects of the Company and its Subsidiaries on a consolidated basis, each Subsidiary, including any Person who becomes a Subsidiary pursuant to any Permitted Acquisition or Permitted Development, has: (i) where required by applicable law, obtained all required CONs for the operation of any Permitted Business created by such Subsidiary or investment in such Subsidiary; (ii) obtained and maintains in good standing all Health Facility Licenses necessary to operate such Subsidiary as a Permitted Business; (iii) obtained and maintains, where appropriate, Medicaid Certification and Medicare Certification with respect to such Subsidiary to the extent required for reimbursement under the Medicaid Regulations or the Medicare Regulations, as the case may be; and (iv) entered into and maintains in good standing, where appropriate, its Medicaid Provider Agreement and its Medicare Provider Agreement with respect to such Subsidiary to the extent required for reimbursement under the Medicaid Regulations or the Medicare Regulations, as the case may be. (b) The Company and its Subsidiaries, including any Person who becomes a Subsidiary, will use their best efforts to maintain any certifications received from the JCAHO or the AAAHC or any such other applicable accrediting body to the extent required, and to obtain such certifications from the JCAHO or the AAAHC or any such other applicable accrediting body not obtained as at the Effective Date, each Loan Party is in compliance with, and is conducting and, for the six years preceding the Effective Date, has conducted its respective business and operations in compliance with, the requirements of all Health Care Laws and Public Health Laws, except for if failure to maintain or obtain such non-compliance which, individually or in the aggregate, is not certifications would reasonably likely be expected to result in constitute a Material Adverse Effect. (bc) The Borrower and its Subsidiaries Except as disclosed on Schedule 5.19, all necessary steps have all Registrations issued been or supervised by any Public Health Regulatory Agency or other Governmental Authority required are being taken to conduct their respective businesses as currently conducted, except where secure the failure to have all such Registrations could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. Each of such Registrations is valid and subsisting in full force and effect, except where the failure to be so could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. To the knowledge of the Borrower and its Subsidiaries, none renewal of any Public Health Regulatory Agency Facility License, Medicaid Provider Agreement or any other Governmental Authority is considering limiting, suspending, or revoking such party’s submission Medicare Provider Agreement issued with respect to any Public Health Regulatory Agency or any other Governmental Authority; providedSubsidiary that is to expire within 60 days after the date of execution and delivery of this Agreement by the Banks, that, in each case of the foregoing clauses, where such false or misleading information or omissions could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities and excluding any material limitations or omissions that were clearly disclosed there is no reasonable basis known to the recipient of a listed item. The Borrower and its Subsidiaries have not failed to fulfill and perform their obligations which are due under each Registration held by Company or licensed to them, and no event has occurred or condition or state of facts exists which would constitute a breach or default under any such Registration, in each case that would reasonably be expected to cause Material Regulatory Liabilities. To the knowledge of the Borrower and its Subsidiaries, any third party that is a manufacturer or contractor for the Borrower and its Subsidiaries is in compliance with all Registrations from any Public Health Regulatory Agency and any other Governmental Authority insofar as they pertain to the manufacture of product components or products or the analysis or generation of data for the Borrower and its Subsidiaries, except where the failure to so be in compliance would not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (c) All products developed, manufactured, tested, distributed, marketed, or sold by or on behalf of the Borrower and its Subsidiaries that are subject to the jurisdiction of any Public Health Regulatory Agency or any other Governmental Authority (x) have been and are being developed, tested, manufactured, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Law, including, without limitation and to the extent applicable, in material compliance with any pre-market notification or pre-market approval requirements, good manufacturing practices, quality system requirements, labeling requirements, advertising requirements, record keeping requirements and adverse event reporting requirements, and (y) have been and are being tested, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Law, except, in each case of clauses (x) and (y), where such noncompliance would renewal will not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilitiesobtained. (d) The Borrower and its Subsidiaries have not received and Except as disclosed on Schedule 5.19, there are not subject no proceedings pending, or, to the best knowledge of the Company or any Subsidiary after due inquiry, threatened by any Governmental Authority seeking to modify, revoke or suspend any Health Facility License, or, to the extent required for reimbursement, Medicaid Provider Agreement, Medicare Provider Agreement, Medicare Certification or Medicaid Certification with respect to any administrative or regulatory actionSubsidiary, warning letter, notice of violation letter, or other similar written notice, complaint nor is there pending any governmental investigation or inquiry made by which might result in fines or penalties which could materially adversely affect any Public Health Regulatory Agency or any other Governmental Authority asserting that Subsidiary. Since the development, testing, investigation, manufacture, distribution, marketing or sale date of the products most recent Medicare Certification and Medicaid Certification with respect to each Subsidiary (where applicable), to the best knowledge of any Borrower the Company or any of its Subsidiaries is not in compliance after due inquiry, neither the Company nor any Subsidiary has taken any action that would materially adversely affect the Certification or the Medicare Provider Agreement or Medicaid Provider Agreement with any applicable law, except those noncompliance that could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. To the extent applicable, (x) the Borrower and its Subsidiaries have made all notifications, submissions, and reports required by any respect to such Governmental Authority, and (y) all such notifications, submissions and reports provided by the Borrower and its Subsidiaries were, to their knowledge, true, complete, and correct in all material respects as of the date of submission to any Public Health Regulatory Agency or any other Governmental Authority, except, where such failure to comply with (x) or (y) could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory LiabilitiesSubsidiary. (e) No product Neither the Company, any Subsidiary, any Affiliate nor any officer or director of the Borrower foregoing has engaged in any of the following: (i) knowingly and wilfully making or causing to be made a false statement or representation of a material fact in any application for any benefit or payment under Medicare or Medicaid; (ii) knowingly and wilfully making or causing to be made any false statement or representation of a material fact for use in determining rights to any benefit or payment under Medicare or Medicaid; (iii) failing to disclose knowledge by a claimant of the occurrence of any event affecting the initial or continued right to any benefit or payment under Medicare or Medicaid on its Subsidiaries has been seizedown behalf or on behalf of another, withdrawnwith intent to secure such benefit or payment fraudulently; (iv) knowingly and wilfully soliciting or receiving any remuneration (including any kickback, recalledbribe or rebate), detaineddirectly or indirectly, overtly or subject covertly, in cash or in kind or offering to pay such remuneration (1) in return for referring an individual to a suspension Person for the furnishing or arranging for the furnishing of manufacturingany item or service for which payment may be made in whole or in part by Medicare or Medicaid or (2) in return for purchasing, andleasing or ordering or arranging for or recommending the purchasing, leasing or ordering of any good, facility, service or item for which payment may be made in whole or in part by Medicare or Medicaid. With respect to this subsection 5.19(e), knowledge by a Responsible Officer of the Company or of a Subsidiary of any events described in this subsection 5.19(e) shall not be imputed to the Company or such Subsidiary unless such knowledge was obtained or learned by such Responsible Officer in his or her official capacity as a Responsible Officer of the BorrowerCompany or such Subsidiary. No activity of the Company, there are no facts any Subsidiary, any Affiliate or circumstances reasonably likely any director or officer of the foregoing shall be considered to cause (xbe a breach of this subsection 5.19(e) unless the seizureCompany, denial, withdrawal, recall, detention, field a Subsidiary or an Affiliate of the foregoing has received notification, field correctionwritten or oral, safety alert or suspension by a Governmental Authority of manufacturing relating competent jurisdiction as to any such product; (y) a material adverse change in the labeling of any such product; or (z) a termination, seizure or suspension of marketing of any such product, except, in each case, where such events could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any such product are pending or, to the knowledge the Borrower or its Subsidiaries, threatened against the Borrower and its Subsidiaries, except where such proceeding could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilityviolation.

Health Care Regulatory Matters. (a) As of the Effective Date, each Loan Party is Except as set forth in compliance with, and is conducting and, for the six years preceding the Effective Date, has conducted its respective business and operations in compliance with, the requirements of all Health Care Laws and Public Health Laws, except for such non-compliance whichSchedule 3.23 or as would not, individually or in the aggregate, is reasonably be expected to have a Material Adverse Effect, and since January 1, 2017: (a) The Company and its Subsidiaries, and to the Knowledge of Sellers, each of their directors, officers, management employees, agents (while acting in such capacity), contract manufacturers, suppliers, and distributors are, and at all times after January 1, 2017 were, in compliance with all Health Care Laws to the extent applicable to the Company or any of its products or activities, except, with respect to such agents, contractors, manufacturers, suppliers and distributors, as would not reasonably likely be expected to result prevent the Company and its Subsidiaries from being in such compliance themselves. To the Knowledge of Sellers, there are no facts or circumstances that reasonably would be expected to give rise to any failure by the Company and its Subsidiaries to be in such compliance under any Health Care Laws that would reasonably be expected to give rise to a Material Adverse Effect. (b) The Borrower All material Governmental Authorizations required by the Health Care Laws are in full force and effect. Neither the Company nor any of its Subsidiaries have knowledge of any facts or circumstances that would be reasonably likely to lead the revocation, suspension, limitation, or cancellation of a Governmental Authorization required under Health Care Laws or of any application for a Governmental Authorization required under Health Care Laws currently pending before the FDA, DEA, or such other Governmental Body. (c) All reports, documents, claims, notices, or Governmental Authorizations required under Health Care Laws to be filed, maintained or furnished to the FDA, DEA, or any Governmental Body by the Company and its Subsidiaries have all Registrations issued been so filed, maintained or supervised by any Public Health Regulatory Agency or other Governmental Authority required to conduct their respective businesses as currently conductedfurnished, except where the failure to file, maintain or furnish such reports, documents, claims, notices, or Governmental Authorizations have all such Registrations could not had and would not reasonably be expected toto have, individually or in the aggregate, result in a Material Regulatory Liabilities. Each of such Registrations is valid and subsisting in full force and effect, except where the failure to be so could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory LiabilitiesAdverse Effect. To the knowledge Knowledge of Sellers all such reports, documents, claims, notices, and other Governmental Authorizations were true and complete in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). (d) All preclinical and clinical trials conducted by or, to the Knowledge of Sellers, on behalf of the Borrower and Company or any of its Subsidiaries, none of any Public Health Regulatory Agency or any other Governmental Authority is considering limiting, suspending, or revoking such party’s submission to any Public Health Regulatory Agency or any other Governmental Authority; provided, that, in each case of the foregoing clauses, where such false or misleading information or omissions could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities and excluding any material limitations or omissions that were clearly disclosed to the recipient of a listed item. The Borrower and its Subsidiaries have not failed to fulfill and perform their obligations which are due under each Registration held by or licensed to thembeen, and no event has occurred or condition or state of facts exists which would constitute a breach or default under any such Registrationif still pending are being, in each case that would reasonably be expected to cause Material Regulatory Liabilities. To the knowledge of the Borrower and its Subsidiaries, any third party that is a manufacturer or contractor for the Borrower and its Subsidiaries is conducted in compliance with research protocols and all Registrations from any Public applicable Health Regulatory Agency and any other Governmental Authority insofar as they pertain to Care Laws, including the manufacture of product components or products or the analysis or generation of data for the Borrower FDCA and its Subsidiariesapplicable implementing regulations at 21 C.F.R. Parts 50, except where the failure to so be in compliance would not reasonably be expected to54, individually or in the aggregate56, result in Material Regulatory Liabilities. (c) All products developed58, manufactured312, tested314, distributed320, marketed511, or sold and 814. No clinical trial conducted by or on behalf of the Borrower and Company or its Subsidiaries has been terminated or suspended prior to completion, and no clinical investigator that are subject has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Company or its Subsidiaries has placed a clinical hold order on, or otherwise terminated, delayed or suspended, such a clinical trial at a clinical research site based on an actual or alleged lack of safety or efficacy of any Product or a failure to conduct such clinical trial in compliance with applicable Health Care Laws. (e) All manufacturing operations conducted by or, to the jurisdiction Knowledge of any Public Health Regulatory Agency Sellers, for the benefit of the Company or any other Governmental Authority (x) its Subsidiaries have been and are being developed, tested, manufactured, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Law, including, without limitation and to the extent applicable, conducted in material compliance with any preall Governmental Authorizations issued by a Governmental Body under Health Care Laws and in material compliance with all applicable Health Care Laws, including the FDA’s current Good Manufacturing Practice (cGMP) regulations at 21 C.F.R. Parts 210-market notification or pre-market approval requirements211, good manufacturing practicesQuality System (QS) regulations at 21 C.F.R. Part 820, quality system requirements, labeling requirements, advertising requirements, record keeping requirements and adverse event reporting requirementsanimal drug cGMP regulations at 21 C.F.R. Part 507, and all comparable foreign regulatory requirements of any Governmental Body. (yf) Neither the Company nor any of its Subsidiaries have received any written communication or, to the Knowledge of Sellers, any oral communication from an applicable Governmental Body that relates to an alleged violation or non-compliance with any Health Care Laws, including any notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration, import detention or refusal, subpoena, civil investigative demand, FDA Warning Letter or Untitled Letter, or any action by a Governmental Body relating to any Health Care Laws, in each case, that has not been resolved to the satisfaction of the applicable Governmental Body. (g) Neither the Company nor any of its Subsidiaries are party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Body. (h) There have been and are being testedno seizures, investigatedwithdrawals, distributedrecalls, marketeddetentions, and sold in or suspensions of manufacturing or distribution relating to the Products required or requested by a Governmental Body, or voluntary recalls, field notifications, field corrections, product removals, market withdrawals or replacements, “dear doctor” letters, safety alerts, or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance with of the applicable Public Health Laws or any other applicable Law, exceptProducts (“Safety Notices”), in each case of clauses (x) and (y), where such noncompliance would that has not reasonably be expected to, individually or in been resolved to the aggregate, result in Material Regulatory Liabilities. (d) The Borrower and its Subsidiaries have not received and are not subject to any administrative or regulatory action, warning letter, notice of violation letter, or other similar written notice, complaint or inquiry made by any Public Health Regulatory Agency or any other Governmental Authority asserting that the development, testing, investigation, manufacture, distribution, marketing or sale satisfaction of the products of any Borrower or any of its Subsidiaries is not in compliance with any applicable law, except those noncompliance that could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory LiabilitiesGovernmental Body. To the extent applicable, (x) the Borrower and its Subsidiaries have made all notifications, submissions, and reports required by any such Governmental Authority, and (y) all such notifications, submissions and reports provided by the Borrower and its Subsidiaries were, to their knowledge, true, complete, and correct in all material respects as Knowledge of the date of submission to any Public Health Regulatory Agency or any other Governmental Authority, except, where such failure to comply with (x) or (y) could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (e) No product of the Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, and, to the knowledge of the BorrowerSellers, there are no facts or circumstances that reasonably likely would be expected to cause give rise to a Safety Notice. (xi) Neither the seizureCompany, denialnor its Subsidiaries, withdrawalnor, recallto the Knowledge of Sellers, detentionany officer, field notificationemployee, field correctionagent, safety alert or suspension distributor of manufacturing relating to the Company or any such product; (y) of its Subsidiaries has made an untrue statement of a material adverse change in the labeling of any such product; fact or (z) fraudulent or misleading statement to a terminationGovernmental Body, seizure failed to disclose a material fact required to be disclosed to a Governmental Body, or suspension of marketing of any such productcommitted an act, exceptmade a statement, in each case, where such events could not or failed to make a statement that would reasonably be expected toto provide a basis for the FDA to invoke its policy respecting “Fraud, individually 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 (the “FDA Ethics Policy”). None of the aforementioned is or has been under investigation resulting from any allegedly untrue, fraudulent, misleading, or false statement or omission, including data fraud, or had any action pending or threatened relating to the FDA Ethics Policy. (j) Neither the Company, nor its Subsidiaries, nor, to the Knowledge of Sellers, any officer, employee, agent, or distributor acting on behalf of the Company or any of its Subsidiaries has committed any act, made any statement or failed to make any statement in connection with the business and operations of the Company and its Subsidiaries that violates the federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x, the federal False Claims Act, 31 U.S.C. § 3729 et seq., or other Health Care Laws applicable in the aggregatejurisdictions in which the Products are sold or intended to be sold. (k) Neither the Company nor its Subsidiaries, result nor, to the Knowledge of Sellers, any officer, employee, agent, or distributor of the Company or its Subsidiaries has been convicted of any crime or engaged in Material Regulatory Liabilities. No proceedings any conduct that has resulted, or would reasonably be expected to result, in the United States debarment under 21 U.S.C. § 335a, exclusion under 42 U.S.C. § 1320a-7, or any other jurisdiction seeking Health Care Law applicable in other jurisdictions in which the withdrawalProducts are sold or intended to be sold. (l) The Company and each of its Subsidiaries (i) are and have been in compliance with all applicable statutes, recallregulations, suspensionrules, import detentionand regulatory guidance relating to Product pricing, or seizure price reporting, discounts, and rebates, including those relating to the Medicaid Drug Rebate Program, the 340B Drug Pricing Program, the Medicare Part B Program, the Veterans Health Care Act Drug Pricing Program, and applicable state price reporting laws, and (ii) have calculated and reported the applicable pricing metrics under the foregoing programs (including Average Manufacturer Price, Best Price, 340B Ceiling Price, Average Sales Price, and Non-Federal Average Manufacturer Price) consistent with the applicable Health Care Laws associated with the foregoing programs. (m) Neither the Company nor any of any such product are pending orits Subsidiaries, nor, to the knowledge Knowledge of Sellers, any officer, employee, agent or distributor of the Borrower Company or any of its Subsidiaries, threatened against has been excluded from participation in any federal health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Borrower and its SubsidiariesSocial Security Act of 1935, except where such proceeding could not reasonably be expected toas amended, individually or in the aggregate, result in Material Regulatory Liabilityunder any other Health Care Law.

Health Care Regulatory Matters. Except as disclosed on Schedule ------------------------------ 1 hereto: (ai) As of the Effective DateExcept as, each Loan Party is in compliance with, and is conducting and, for the six years preceding the Effective Date, has conducted its respective business and operations in compliance with, the requirements of all Health Care Laws and Public Health Laws, except for such non-compliance which, individually or in the aggregate, is not reasonably likely to result in a Material Adverse Effect. (b) The Borrower and its Subsidiaries have all Registrations issued or supervised by any Public Health Regulatory Agency or other Governmental Authority required to conduct their respective businesses as currently conducted, except where the failure to have all such Registrations could not reasonably be expected toto have a Material Adverse Effect, individually or (A) the Lessee now has (after giving effect to the Recapitalization), and has no reason to believe it will not be able to maintain in the aggregate, result in Material Regulatory Liabilities. Each of such Registrations is valid and subsisting in full force and effect, except where all Health Care Permits necessary for the failure lawful conduct of its business or operations wherever now conducted and as planned to be so conducted (other than those Health Care Permits the lack of which could not reasonably be expected toto have a Material Adverse Effect), individually or including, without limitation, the ownership and operation of its Health Care Facilities pursuant to all Requirements of Law, (B) all such Health Care Permits are in the aggregate, result in Material Regulatory Liabilities. To the knowledge of the Borrower full force and its Subsidiaries, none of any Public Health Regulatory Agency or any other Governmental Authority is considering limiting, suspending, or revoking such party’s submission to any Public Health Regulatory Agency or any other Governmental Authority; provided, that, in each case of the foregoing clauses, where such false or misleading information or omissions could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities effect and excluding any material limitations or omissions that were clearly disclosed to the recipient of a listed item. The Borrower and its Subsidiaries have not failed to fulfill and perform their obligations which are due under been amended or otherwise modified, rescinded, revoked or assigned, (C) the Lessee is substantially complying with the requirements of each Registration held by or licensed to themsuch Health Care Permit, and no event has occurred occurred, and no condition exists, which, with the giving of notice, the passage of time, or condition or state of facts exists which both, would constitute a breach or default under violation thereof, (D) the Lessee has not received any such Registration, in each case that would reasonably be expected to cause Material Regulatory Liabilities. To the knowledge of the Borrower and its Subsidiaries, any third party that is a manufacturer or contractor for the Borrower and its Subsidiaries is in compliance with all Registrations from any Public Health Regulatory Agency and any other Governmental Authority insofar as they pertain to the manufacture of product components or products or the analysis or generation of data for the Borrower and its Subsidiaries, except where the failure to so be in compliance would not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (c) All products developed, manufactured, tested, distributed, marketed, or sold by or on behalf of the Borrower and its Subsidiaries that are subject to the jurisdiction written notice of any Public Health Regulatory Agency or violation of any other Governmental Authority (x) have been and are being developed, tested, manufactured, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Requirement of Law, including, without limitation and to the extent applicable, in material compliance with any pre-market notification or pre-market approval requirements, good manufacturing practices, quality system requirements, labeling requirements, advertising requirements, record keeping requirements and adverse event reporting requirements, and (yE) have been and are being tested, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Law, except, in each case of clauses (x) and (y), where such noncompliance would not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (d) The Borrower and its Subsidiaries have not received and are not subject to any administrative or regulatory action, warning letter, notice of violation letter, or other similar written notice, complaint or inquiry made by any Public Health Regulatory Agency or any other Governmental Authority asserting that the development, testing, investigation, manufacture, distribution, marketing or sale of the products of any Borrower or any of its Subsidiaries is not in compliance with any applicable law, except those noncompliance that could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. To the extent applicable, (x) the Borrower and its Subsidiaries have made all notifications, submissions, and reports required by any such Governmental Authority, and (y) all such notifications, submissions and reports provided by the Borrower and its Subsidiaries were, to their knowledge, true, complete, and correct in all material respects as of the date of submission to any Public Health Regulatory Agency or any other Governmental Authority, except, where such failure to comply with (x) or (y) could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (e) No product of the Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, and, to the knowledge of Lessee, no condition exists or event has occurred which in itself or with the Borrowergiving of notice or the lapse of time, there are no facts or circumstances reasonably likely to cause (x) the seizureboth, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; (y) a material adverse change would result in the labeling suspension, revocation, impairment, forfeiture or non-renewal of any such product; or Health Care Permit, (zF) a termination, seizure or suspension there is no claim filed with any Governmental Authority of marketing which Lessee has been notified challenging the validity of any such productHealth Care Permit and (G) the continuation, except, in each case, where validity and effectiveness of all such events could Health Care Permits will not reasonably be expected to, individually adversely affected by the Recapitalization or in the aggregate, result in Material Regulatory Liabilities. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure execution and performance of any of the Loan Documents or Operative Agreements. (ii) All Health Care Facilities owned, leased, managed or operated by Lessee are entitled to participate in, and receive payment under, the appropriate Medicare, Medicaid and related reimbursement programs, and any similar state or local government-sponsored program, to the extent that Lessee has decided to participate in any such product program, and to receive reimbursement from private and commercial payers and health maintenance organizations to the extent applicable thereto. There are no proceedings pending or, to the knowledge of Lessee, any proceedings threatened or investigations pending or threatened, by any Governmental Authority with respect to the Borrower Lessee's participation in the Medicare, Medicaid or its Subsidiaries, threatened against the Borrower related reimbursement programs and its Subsidiaries, except where such proceeding which could not reasonably be expected to, individually or in the aggregate, result in to have a Material Regulatory LiabilityAdverse Effect.

Health Care Regulatory Matters. (a) As of the Effective Date, each Loan Party is in compliance with, and is conducting and, for the six years preceding the Effective Date, has conducted its respective business and operations in compliance with, the requirements of all Health Care Laws and Public Health Laws, except for such non-compliance which, individually or in the aggregate, is Except as would not be reasonably likely to result in have a Company Material Adverse Effect.: (bi) The Borrower and its Subsidiaries have all Registrations issued since April 1, 2010, no investigation or supervised review by any Public Health Care Regulatory Agency or other Governmental Authority required to conduct their respective businesses as currently conducted, except where the failure to have all such Registrations could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. Each of such Registrations is valid and subsisting in full force and effect, except where the failure to be so could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. To the knowledge of the Borrower and its Subsidiaries, none of any Public Health Regulatory Agency or any other Governmental Authority is considering limiting, suspending, or revoking such party’s submission to any Public Health Regulatory Agency or any other Governmental Authority; provided, that, in each case of the foregoing clauses, where such false or misleading information or omissions could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities and excluding any material limitations or omissions that were clearly disclosed with respect to the recipient of a listed item. The Borrower and its Subsidiaries have not failed to fulfill and perform their obligations which are due under each Registration held by or licensed to them, and no event has occurred or condition or state of facts exists which would constitute a breach or default under any such Registration, in each case that would reasonably be expected to cause Material Regulatory Liabilities. To the knowledge of the Borrower and its Subsidiaries, any third party that is a manufacturer or contractor for the Borrower and its Subsidiaries is in compliance with all Registrations from any Public Health Regulatory Agency and any other Governmental Authority insofar as they pertain to the manufacture of product components or products or the analysis or generation of data for the Borrower and its Subsidiaries, except where the failure to so be in compliance would not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (c) All products developed, manufactured, tested, distributed, marketed, or sold by or on behalf of the Borrower and its Subsidiaries that are subject to the jurisdiction of any Public Health Regulatory Agency or any other Governmental Authority (x) have been and are being developed, tested, manufactured, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Law, including, without limitation and to the extent applicable, in material compliance with any pre-market notification or pre-market approval requirements, good manufacturing practices, quality system requirements, labeling requirements, advertising requirements, record keeping requirements and adverse event reporting requirements, and (y) have been and are being tested, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Law, except, in each case of clauses (x) and (y), where such noncompliance would not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (d) The Borrower and its Subsidiaries have not received and are not subject to any administrative or regulatory action, warning letter, notice of violation letter, or other similar written notice, complaint or inquiry made by any Public Health Regulatory Agency or any other Governmental Authority asserting that the development, testing, investigation, manufacture, distribution, marketing or sale of the products of any Borrower Company or any of its Subsidiaries is not pending or, to the Knowledge of the Company, threatened in compliance with writing, nor, to the Knowledge of the Company, has any Health Care Regulatory Authority indicated in writing an intention to conduct the same; (ii) all material applications and other material documents submitted by the Company or the Company’s Subsidiaries to any applicable lawHealth Care Regulatory Authorities since April 1, except those noncompliance that could not reasonably be expected to, individually or 2010 in the aggregate, result in Material connection with a Health Care Regulatory Liabilities. To the extent applicable, (x) the Borrower and its Subsidiaries have made all notifications, submissions, and reports required by any such Governmental Authority, and (y) all such notifications, submissions and reports provided by the Borrower and its Subsidiaries were, to their knowledge, true, complete, Permit were true and correct in all material respects as of the date of submission in all material respects, and any material updates, changes, corrections or modification to such applications and other documents to the extent required under applicable Health Care Regulatory Laws have been submitted or are in the process of being timely submitted; (iii) Section 5.1(v)(iii) of the Company Disclosure Letter sets forth a true and complete list of all material Health Care Regulatory Permits of the Company and its subsidiaries from applicable Health Care Regulatory Authorities relating to the ability of the Company and its Subsidiaries to research, manufacture, package or market each of their Products, including Abbreviated New Drug Applications. All such Health Care Regulatory Permits are, in all material respects, (i) validly registered and on file with applicable Health Care Regulatory Authorities and (ii) in compliance with all material formal filing and maintenance requirements; and (iii) in good standing, valid, and enforceable. Since April 1, 2010, the Company and its Subsidiaries have filed or are in the process of timely filing all required notices and responses to notices, supplemental applications, reports (including adverse experience reports) and other material information required by applicable Health Care Regulatory Authorities. The Company and its Subsidiaries possess all Health Care Regulatory Permits required for the conduct of their businesses as currently conducted; (iv) there are no, and have not been since April 1, 2010 any, inspection observations, warning or untitled letters, notices pursuant to 21 U.S.C. Section 305 or similar documents issued to the Company or its Subsidiaries that assert a lack of compliance with any Public applicable Health Care Regulatory Agency Laws that, to the Company’s Knowledge, have not been fully resolved to the satisfaction of any applicable Health Care Regulatory Authorities. There is no pending regulatory action, or, to the Knowledge of the Company, inquiry of any sort against any of the Company or its Subsidiaries initiated by any Health Care Regulatory Authority. Without limiting the foregoing, (A) except as set forth in Section 5.1(v)(iv) of the Company Disclosure Letter, there have been no Product warnings, notifications or safety alerts conducted or issued by the Company or its Subsidiaries, or any other Governmental AuthorityHealth Care Regulatory Authorities or otherwise with respect to the Products since April 1, except2010, where such failure and to comply with (x) or (y) could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. (e) No product Knowledge of the Borrower Company, none of the foregoing has been requested or demanded in writing by any Health Care Regulatory Authority; and (B) neither the Company or its Subsidiaries has been seizedconvicted of, withdrawncharged with, recalled, detained, or subject to a suspension of manufacturing, and, to the knowledge of the Borrower, there are no facts or circumstances reasonably likely to cause (x) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; (y) a material adverse change in the labeling of any such product; or (z) a termination, seizure or suspension of marketing of any such product, except, in each case, where such events could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any such product are pending or, to the knowledge Knowledge of the Borrower Company, investigated for any crime or engaged in any conduct which would reasonably be likely to result in criminal liability, civil fraud charges by a Governmental Entity, debarment or disqualification by any Health Care Regulatory Authority, no criminal, injunctive, seizure or civil penalty actions have at any time been commenced or, to the Knowledge of the Company, threatened in writing by any Health Care Regulatory Authority against the Company or any Subsidiary of the Company, and there are no consent decrees or similar actions to which the Company or any Subsidiary of the Company is bound or which relate to any of their Products. To the Knowledge of the Company, neither the Company nor any Subsidiary of the Company is employing or utilizing the services of any individual who has been debarred, excluded, temporarily denied approval or suspended under any Health Care Regulatory Law to which any of their Products are subject or which the Company or any Subsidiary of the Company is barred from employing or utilizing. Neither the Company nor any Subsidiary of the Company has made any untrue statement of fact or fraudulent statement to any such Health Care Regulatory Authority, nor have they failed to disclose any fact required to be disclosed to any Health Care Regulatory Authority; (v) the Company and its Subsidiaries have made available to Parent a summary of all adverse event reports regarding loss of smell and/or loss of taste for the periods from January 1, 2009 through November 30, 2010 and periodic adverse event reports and other pharmacovigilance reports and data as requested by Parent; (vi) to the Knowledge of the Company, all studies conducted or being conducted with respect to any of the Products of the Company or its Subsidiaries by the Company or any Subsidiary of the Company have been, and are being, conducted in all material respects in compliance with the applicable requirements of all Health Care Regulatory Laws that relate to the conduct of clinical studies issued by any applicable Health Care Regulatory Authority; and (vii) since April 1, 2010, to the Knowledge of the Company, any third-party manufacturing operations performed on behalf of the Company or any Subsidiary of the Company are being conducted in all material respects in compliance with the applicable requirements of current U.S. Food and Drug Administration (“FDA”) regulations governing good manufacturing practices, including the FDA’s current Good Manufacturing Practice Regulations at 21 C.F.R. Parts 111, 210 and 211. In addition, the Company and each Subsidiary of the Company, and to the Knowledge of the Company, any third-party manufacturer of the Company or any of its Subsidiaries, threatened against is, in all material respects, in compliance with all applicable material registration and listing requirements, including, for example, those set forth in 21 U.S.C. Section 360 and 21 C.F.R. Part 207 and all similar applicable Health Care Regulatory Laws to the Borrower and extent such compliance is required with respect to the activities being performed on behalf of the Company or any of its Subsidiaries. To the Knowledge of the Company, except where such proceeding could not reasonably be expected tono Product of the Company or any of its Subsidiaries in inventory is adulterated or misbranded, individually or if already sold since April 1, 2010, was adulterated or misbranded at the time of the sale. All Product labeling is in all material respects in compliance with FDA and other applicable Health Care Regulatory Authority requirements, and all advertising and promotional materials of the aggregateCompany and each Subsidiary of the Company are in all material respects in compliance with the FDA and other applicable Health Care Regulatory Authorities. (viii) As used in this agreement, result in Material Regulatory Liability.the term

Health Care Regulatory Matters. (a) As Except as disclosed in Item 5.19 ("Regulatory Matters") of the Effective Date, each Loan Party is in compliance with, Disclosure Schedule and is conducting and, for except to the six years preceding the Effective Date, has conducted its respective business and operations in compliance with, the requirements of all Health Care Laws and Public Health Laws, except for such non-compliance which, individually or in the aggregate, is not reasonably likely to result in a Material Adverse Effect. (b) The Borrower and its Subsidiaries have all Registrations issued or supervised by any Public Health Regulatory Agency or other Governmental Authority required to conduct their respective businesses as currently conducted, except where extent that the failure to have all such Registrations could not reasonably be expected to, individually obtain or in the aggregate, result in Material Regulatory Liabilities. Each of such Registrations is valid and subsisting in full force and effect, except where the failure to be so could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. To the knowledge maintain any of the Borrower and its Subsidiaries, none of any Public Health Regulatory Agency or any other Governmental Authority is considering limiting, suspending, or revoking such party’s submission items in clauses (i) through (iv) below would not be material to any Public Health Regulatory Agency or any other Governmental Authority; provided, that, in each case the conduct of the foregoing clausesBorrower's business, each Facility or the appropriate Subsidiary, as the case may be, has: (i) where such false or misleading information or omissions could not reasonably be expected torequired by Applicable Law, individually or in the aggregate, result in Material Regulatory Liabilities and excluding any material limitations or omissions that were clearly disclosed to the recipient of a listed item. The Borrower and its Subsidiaries have not failed to fulfill and perform their obligations which are due under each Registration held by or licensed to them, and no event has occurred or condition or state of facts exists which would constitute a breach or default under any such Registration, in each case that would reasonably be expected to cause Material Regulatory Liabilities. To the knowledge of the Borrower and its Subsidiaries, any third party that is a manufacturer or contractor obtained all required CONs for the Borrower and its Subsidiaries is construction or expansion of or investment in compliance with all Registrations from any Public Health Regulatory Agency and any other Governmental Authority insofar as they pertain to the manufacture of product components or products or the analysis or generation of data for the Borrower and its Subsidiaries, except where the failure to so be in compliance would not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities.such Facility; (cii) All products developedobtained and maintains all Health Facility Licenses necessary to operate such Facility as a long-term care facility, manufacturedwhether skilled nursing, testedintermediate nursing, distributedassisted living, marketed, Alzheimer units or sold by or on behalf of the Borrower other services; (iii) obtained and its Subsidiaries that are subject maintains Medicaid Certification and Medicare Certification with respect to the jurisdiction of any Public Health Regulatory Agency or any other Governmental Authority (x) have been and are being developed, tested, manufactured, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Law, including, without limitation and such Facility to the extent applicable, in material compliance with any pre-market notification or pre-market approval requirements, good manufacturing practices, quality system requirements, labeling requirements, advertising requirements, record keeping requirements and adverse event reporting requirements, and (y) have been and are being tested, investigated, distributed, marketed, and sold in compliance with the applicable Public Health Laws or any other applicable Law, except, in each case of clauses (x) and (y), where such noncompliance would not reasonably be expected to, individually or Facility participates in the aggregateMedicaid or Medicare program, result in Material Regulatory Liabilities.as the case may be; (div) The Borrower entered into and maintains its Medicaid Provider Agreement and its Subsidiaries have not received and are not subject Medicare Provider Agreement with respect to any administrative or regulatory action, warning letter, notice of violation letter, or other similar written notice, complaint or inquiry made by any Public Health Regulatory Agency or any other Governmental Authority asserting that the development, testing, investigation, manufacture, distribution, marketing or sale of the products of any Borrower or any of its Subsidiaries is not in compliance with any applicable law, except those noncompliance that could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. To the extent applicable, (x) the Borrower and its Subsidiaries have made all notifications, submissions, and reports required by any such Governmental Authority, and (y) all such notifications, submissions and reports provided by the Borrower and its Subsidiaries were, to their knowledge, true, complete, and correct in all material respects as of the date of submission to any Public Health Regulatory Agency or any other Governmental Authority, except, where such failure to comply with (x) or (y) could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities.Facility; and (ev) No product of the Borrower or its Subsidiaries has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, andnot received, to the knowledge of the Borrower, any Hill-Burton Act funds nor has any obligations with respect to Xxxx-Xxxxxn Act charity care. (b) Except as disclosed in Itex 0.00 ("Xxgulatory Matters") of the Disclosure Schedule, all necessary steps have been or are being taken to secure the renewal of any Health Facility License, Medicaid Provider Agreement or Medicare Provider Agreement issued with respect to any Facility that is to expire within 60 days after the Effective Date and that is material to the conduct of the Borrower's business, and there is no reasonable basis known to the Borrower or its Subsidiaries that any such renewal will not be obtained. (c) Except as disclosed in Item 5.19 ("Regulatory Matters") of the Disclosure Schedule, there are no facts or circumstances reasonably likely to cause (x) the seizureproceedings pending, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; (y) a material adverse change in the labeling of any such product; or (z) a termination, seizure or suspension of marketing of any such product, except, in each case, where such events could not reasonably be expected to, individually or in the aggregate, result in Material Regulatory Liabilities. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention, or seizure of any such product are pending or, to the knowledge best of the Borrower's knowledge, threatened by any Governmental Authority against the Borrower, any Subsidiary or any Affiliate, and/or seeking to modify, revoke or suspend any Health Facility License, Medicaid Provider Agreement, Medicare Provider Agreement, Medicare Certification or Medicaid Certification with respect to any Facility, which would be reasonably likely to have a Material Adverse Effect. Since the date of the most recent Medicare Certification and Medicaid Certification with respect to each Facility, none of the Borrower or its Subsidiaries, threatened against any Subsidiary has taken any action that would materially adversely affect such certification or the Borrower and its Subsidiaries, except where Medicare Provider Agreement or Medicaid Provider Agreement with respect to such proceeding could not reasonably Facility that would be expected to, individually or in material to the aggregate, result in Material Regulatory Liabilityconduct of the Borrower's business.