Common use of Healthcare Regulatory Matters Clause in Contracts

Healthcare Regulatory Matters. Except as (i) otherwise disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus or (ii) would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company and each subsidiary is in compliance with all Healthcare Laws (as defined below) applicable to the business of the Company, relating to the compounding, development, manufacturing, labeling, advertising, promotion, storage and distribution of drug products and medical devices, or the operation or management of home and outpatient infusion centers, pharmacy, patient healthcare information, patient abuse, and the quality and adequacy of infusion or other medical care, including without limitation: (a) federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the Sxxxx Law (42 U.S.C. §1395nn), the Civil False Claims Act (31 U.X.X. §0000 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the civil monetary penalty laws (42 U.S.C. § 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), and any similar state laws or regulations, (b) 42 U.S.C. §§ 1395-1395lll (the Medicare Act), (c) Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 (the Medicaid Act), (d) the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and all regulations promulgated thereto, (e) the Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), (f) the Public Health Service Act (42 U.S.C. § 201 et. seq.), (g) the Controlled Substances Act (21 U.S.C. § 801 et seq.), and any comparable healthcare laws, regulations each of (a) through (g) as may be amended from time to time, and the regulations promulgated thereto (collectively, “Healthcare Laws”). Neither the Company nor any subsidiary is subject to material civil penalties, or mandatory or permissive exclusion from any state or federal healthcare program, including Medicare, Medicaid, TRICARE, CHAMPVA, any state health plan adopted pursuant to Title XIX of the Social Security Act (collectively, “Governmental Program”). Without limiting the generality of the foregoing, neither the Company or any subsidiary has received written notice by a Governmental Authority of any material violation (or of any action, litigation, arbitration, claim, demand, investigation, audit, charge, or formal inquiry (“Proceeding”) involving allegations of any material violation) of any applicable Healthcare Laws, and no such Proceeding involving such allegations of any such material violation is, to the knowledge of the Company, threatened in writing or contemplated, except where such Proceeding would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For the past three (3) years the Company, its subsidiaries, its respective officers, directors, and employees, and, to the knowledge of the Company, its Licensed Providers, are not and have not been, excluded, debarred, suspended or otherwise ineligible to participate in any Governmental Program, and no such action is pending or, to the knowledge of the Company, threatened in writing. Neither the Company or any of its subsidiaries: (i) is a party to or has any reporting obligations under a corporate integrity agreement, deferred or non-prosecution agreement, monitoring agreement, consent decree, settlement order, or any similar agreement with any Governmental Authority; or (ii) has made any submissions pursuant to the Office of Inspector General’s Self Disclosure Protocol or Centers for Medicare and Medicaid Services’ Self-Reporting Disclosure Protocol.

Healthcare Regulatory Matters. Except as (i) otherwise disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus or (ii) would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company and each subsidiary is in compliance with all Healthcare Laws (as defined below) applicable to the business of the Company, relating to the compounding, development, manufacturing, labeling, advertising, promotion, storage and distribution of drug products and medical devices, or the operation or management of home and outpatient infusion centers, pharmacy, patient healthcare information, patient abuse, and the quality and adequacy of infusion or other medical care, including without limitation: (a) federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the Sxxxx Law (42 U.S.C. §1395nn), the Civil False Claims Act (31 U.X.X. §0000 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the civil monetary penalty laws (42 U.S.C. § 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), and any similar state laws or regulations, (b) 42 U.S.C. §§ 1395-1395lll (the Medicare Act), (c) Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396- 1396w-5 (the Medicaid Act), (d) the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and all regulations promulgated thereto, (e) the Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), (f) the Public Health Service Act (42 U.S.C. § 201 et. seq.), (g) the Controlled Substances Act (21 U.S.C. § 801 et seq.), and any comparable healthcare laws, regulations each of (a) through (g) as may be amended from time to time, and the regulations promulgated thereto (collectively, “Healthcare Laws”). Neither the Company nor any subsidiary is subject to material civil penalties, or mandatory or permissive exclusion from any state or federal healthcare program, including Medicare, Medicaid, TRICARE, CHAMPVA, any state health plan adopted pursuant to Title XIX of the Social Security Act (collectively, “Governmental Program”). Without limiting the generality of the foregoing, neither the Company or any subsidiary has received written notice by a Governmental Authority of any material violation (or of any action, litigation, arbitration, claim, demand, investigation, audit, charge, or formal inquiry (“Proceeding”) involving allegations of any material violation) of any applicable Healthcare Laws, and no such Proceeding involving such allegations of any such material violation is, to the knowledge of the Company, threatened in writing or contemplated, except where such Proceeding would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For the past three (3) years the Company, its subsidiaries, its respective officers, directors, and employees, and, to the knowledge of the Company, its Licensed Providers, are not and have not been, excluded, debarred, suspended or otherwise ineligible to participate in any Governmental Program, and no such action is pending or, to the knowledge of the Company, threatened in writing. Neither the Company or any of its subsidiaries: (i) is a party to or has any reporting obligations under a corporate integrity agreement, deferred or non-prosecution agreement, monitoring agreement, consent decree, settlement order, or any similar agreement with any Governmental Authority; or (ii) has made any submissions pursuant to the Office of Inspector General’s Self Disclosure Protocol or Centers for Medicare and Medicaid Services’ Self-Reporting Disclosure Protocol.

Healthcare Regulatory Matters. Except as (i) otherwise disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus or (ii) would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company and each subsidiary is in compliance with all Healthcare Laws (as defined below) applicable to the business of the Company, relating to the compounding, development, manufacturing, labeling, advertising, promotion, storage and distribution of drug products and medical devices, or the operation or management of home and outpatient infusion centers, pharmacy, patient healthcare information, patient abuse, and the quality and adequacy of infusion or other medical care, including without limitation: (a) federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the Sxxxx Xxxxx Law (42 U.S.C. §1395nn), the Civil False Claims Act (31 U.X.X. X.X.X. §0000 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the civil monetary penalty laws (42 U.S.C. § 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), and any similar state laws or regulations, (b) 42 U.S.C. §§ 1395-1395lll (the Medicare Act), (c) Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 (the Medicaid Act), (d) the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and all regulations promulgated thereto, (e) the Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), (f) the Public Health Service Act (42 U.S.C. § 201 et. seq.), (g) the Controlled Substances Act (21 U.S.C. § 801 et seq.), and any comparable healthcare laws, regulations each of (a) through (g) as may be amended from time to time, and the regulations promulgated thereto (collectively, “Healthcare Laws”). Neither the Company nor any subsidiary is subject to material civil penalties, or mandatory or permissive exclusion from any state or federal healthcare program, including Medicare, Medicaid, TRICARE, CHAMPVA, any state health plan adopted pursuant to Title XIX of the Social Security Act (collectively, “Governmental Program”). Without limiting the generality of the foregoing, neither the Company or any subsidiary has received written notice by a Governmental Authority of any material violation (or of any action, litigation, arbitration, claim, demand, investigation, audit, charge, or formal inquiry (“Proceeding”) involving allegations of any material violation) of any applicable Healthcare Laws, and no such Proceeding involving such allegations of any such material violation is, to the knowledge of the Company, threatened in writing or contemplated, except where such Proceeding would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For the past three (3) years the Company, its subsidiaries, its respective officers, directors, and employees, and, to the knowledge of the Company, its Licensed Providers, are not and have not been, excluded, debarred, suspended or otherwise ineligible to participate in any Governmental Program, and no such action is pending or, to the knowledge of the Company, threatened in writing. Neither the Company or any of its subsidiaries: (i) is a party to or has any reporting obligations under a corporate integrity agreement, deferred or non-prosecution agreement, monitoring agreement, consent decree, settlement order, or any similar agreement with any Governmental Authority; or (ii) has made any submissions pursuant to the Office of Inspector General’s Self Disclosure Protocol or Centers for Medicare and Medicaid Services’ Self-Reporting Disclosure Protocol.

Healthcare Regulatory Matters. Except as (i) otherwise disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus Offering Memorandum or (ii) would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company and each subsidiary is in compliance with all Healthcare Laws (as defined below) applicable to the business of the Company, relating to the compounding, development, manufacturing, labeling, advertising, promotion, storage and distribution of drug products and medical devices, or the operation or management of home and outpatient infusion centers, pharmacy, patient healthcare information, patient abuse, and the quality and adequacy of infusion or other medical care, including without limitation: (a) federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the Sxxxx Xxxxx Law (42 U.S.C. §1395nn), the Civil False Claims Act (31 U.X.X. §0000 et xt seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the civil monetary penalty laws (42 U.S.C. § 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), and any similar state laws or regulations, (b) 42 U.S.C. §§ 1395-1395lll (the Medicare Act), (c) Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 (the Medicaid Act), (d) the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and all regulations promulgated thereto, (e) the Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), (f) the Public Health Service Act (42 U.S.C. § 201 et. seq.), (g) the Controlled Substances Act (21 U.S.C. § 801 et seq.), and any comparable healthcare laws, regulations each of (a) through (g) as may be amended from time to time, and the regulations promulgated thereto (collectively, “Healthcare Laws”). Neither the Company nor any subsidiary is subject to material civil penalties, or mandatory or permissive exclusion from any state or federal healthcare program, including Medicare, Medicaid, TRICARE, CHAMPVA, any state health plan adopted pursuant to Title XIX of the Social Security Act (collectively, “Governmental Program”). Without limiting the generality of the foregoing, neither the Company or any subsidiary has received written notice by a Governmental Authority of any material violation (or of any action, litigation, arbitration, claim, demand, investigation, audit, charge, or formal inquiry (“Proceeding”) involving allegations of any material violation) of any applicable Healthcare Laws, and no such Proceeding involving such allegations of any such material violation is, to the knowledge of the CompanyCompany and the Guarantors, threatened in writing or contemplated, except where such Proceeding would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For the past three (3) years the Company, its subsidiaries, its respective officers, directors, and employees, and, to the knowledge of the CompanyCompany and the Guarantors, its Licensed Providers, are not and have not been, excluded, debarred, suspended or otherwise ineligible to participate in any Governmental Program, and no such action is pending or, to the knowledge of the CompanyCompany and the Guarantors, threatened in writing. Neither the Company or any of its subsidiaries: (i) is a party to or has any reporting obligations under a corporate integrity agreement, deferred or non-prosecution agreement, monitoring agreement, consent decree, settlement order, or any similar agreement with any Governmental Authority; or (ii) has made any submissions pursuant to the Office of Inspector General’s Self Disclosure Protocol or Centers for Medicare and Medicaid Services’ Self-Reporting Disclosure Protocol.

Healthcare Regulatory Matters. Except as Without limiting the generality of Section 2.17 or Section 2.21: (ia) otherwise disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus or (ii) would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the The Company and each subsidiary is its Subsidiaries and their respective directors, officers, employees, and agents are, and at all times have been, in compliance with all Healthcare relevant health care Laws (as defined below) applicable to the business of the Company, relating to the compounding, development, manufacturing, labeling, advertising, promotion, storage and distribution of drug products and medical devices, or the operation or management of home and outpatient infusion centers, pharmacy, patient healthcare information, patient abuse, and the quality and adequacy of infusion or other medical care, including without limitation: (a) federal and state fraud and abuse lawsthem, including, without limitationbut not limited to, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Public Health Service Act (42 U.S.C. §§ 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. § 263a et seq.), the federal Anti-Kickback Anti- kickback Statute (42 U.S.C. §§ 1320a-7b(b)), the Sxxxx Law (42 U.S.C. §1395nn), the Civil civil False Claims Act (31 U.X.X. U.S.C. §0000 § 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the civil monetary penalty laws Anti-Inducement Law 29 NY\7370590.17 (42 U.S.C. § 1320a-7a1320a-7a(a)(5)), the exclusion laws (42 U.S.C. § 1320a-7), and any similar state laws or regulations, (b) 42 U.S.C. §§ 1395-1395lll (the Medicare Act), (c) Title XIX administrative simplification provisions of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 (the Medicaid Act), (d) the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and all regulations promulgated thereto, (e) the Food, Drug and Cosmetic Act (21 42 U.S.C. § 301 1320d et seq.), (f) the Public Health Service Act Xxxxx Law (42 U.S.C. § 201 et. seq.1395nn), the exclusion laws, SSA § 1128 (g) 42 U.S.C. 1320a-7), Medicare (Title XVIII of the Controlled Substances Act (21 U.S.C. § 801 et seq.Social Security Act), and any comparable healthcare laws, regulations each of Medicaid (a) through (g) as may be amended from time to time, and the regulations promulgated thereto (collectively, “Healthcare Laws”). Neither the Company nor any subsidiary is subject to material civil penalties, or mandatory or permissive exclusion from any state or federal healthcare program, including Medicare, Medicaid, TRICARE, CHAMPVA, any state health plan adopted pursuant to Title XIX of the Social Security Act Act), and the regulations promulgated pursuant to such Laws, and comparable state Laws, manual provisions, policies and administrative guidance and all other local, state, federal, national, supranational and foreign Laws relating to the regulation of the Company and its Subsidiaries (collectively, “Governmental ProgramHealth Care Laws”). Without limiting the generality None of the foregoing, neither the Company or any subsidiary its Subsidiaries has received written notice by a any notification, correspondence or any other communication from any Governmental Authority Entity of potential or actual non-compliance or liability under any Health Care Laws, or has knowledge of any material circumstances reasonably likely to constitute a violation (or of any actionHealth Care Law. (b) Each of the Company and its Subsidiaries meets all the requirements of participation and payment of any governmental health care program (collectively, litigation, arbitration, claim, demand, investigation, audit, charge, or formal inquiry (“ProceedingGovernment Health Care Programs”) involving allegations of any material violation) of any applicable Healthcare Lawsand third party payment program in which it participates (collectively, “Health Care Programs”), and is a party to valid participation agreements for payment by such Government Health Care Programs if the Company or its Subsidiaries, as applicable, bills a particular Government Health Care Program for services or procedures or is otherwise required to meet such requirements. There is no such Proceeding involving such allegations of any such material violation isLitigation pending, received or, to the knowledge of the Company, threatened against the Company or its Subsidiaries which relates in writing any way to a violation of any Health Care Law or contemplated, except where such Proceeding would not, individually other Law pertaining to the Government Health Care Programs or overpayments which could result in the aggregateimposition of penalties against or the exclusion of either or both of the Company or its Subsidiaries from participation in any Government Health Care Program or termination for cause of any managed care Contract under any Health Care Program. None of the Company nor any of its Subsidiaries or any of their respective officers or directors, reasonably be expected or, to have a Material Adverse Effect. For the past three (3) years knowledge of the Company, any of their respective employees or agents has engaged in any activity which is cause for civil penalties or mandatory or permissive exclusion from any Government Health Care Program. (c) Except as set forth in Section 2.27(c) of the Company Disclosure Schedule, none of the Company nor any Subsidiary is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. (d) The Company and its subsidiaries, its respective officers, directorsSubsidiaries have obtained and maintained each Permit, and employeesall supplements and amendments thereto filed with or issued or granted by, any Governmental Entity (including the FDA and any other Governmental Entity engaged in the regulation of the Business or the products sold or the tests offered by the Business (such products and tests, collectively, the “Products”)), required for the operation of the Business as currently conducted, the holding of any interest in any of its properties and assets, and the operation of its facilities (collectively, “Regulatory Permits”), and all of such Regulatory Permits are in full force and effect. Except as set forth in Section 2.27(d) of the Company Disclosure Schedule, none of the Company or any Subsidiary has received any communication from any Governmental Entity regarding, and, to the knowledge of the Company, there are no facts or circumstances that are likely to give rise to, (i) any material adverse change in any Regulatory Permit, or any failure to materially comply with any applicable Laws or any term or requirement of any Regulatory 30 NY\7370590.17 Permit or (ii) any revocation, withdrawal, suspension, cancellation, limitation, termination or material modification of any Regulatory Permit. (e) All applications, notifications, submissions, information, 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 Regulatory Permit from a Governmental Entity relating to the Company or its Licensed ProvidersSubsidiaries, the Business and the Products (if any), when submitted to such Governmental Entity were true, complete and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modification to such applications, submissions, information and data have been submitted to such Governmental Entity. No Permit from the FDA is required for the sale of Products and the Products and the packaging and labelling of the Products do not violate any FDA requirement. The claims made by the Company and its Subsidiaries with respect to the Products are not valid and supported by proper research, design, testing, analysis and disclosure (to the extent required by applicable Laws and Regulations) and such claims have not beenbeen disapproved or challenged by any Government Entity. (f) Except as set forth in Section 2.27(f) of the Company Disclosure Schedule, excludedduring the past five (5) years, debarredthe Company and its Subsidiaries have not had any manufacturing or laboratory site subject to a Governmental Entity shutdown or import or export prohibition, suspended or otherwise ineligible to participate in nor received any Governmental ProgramEntity notice of inspectional observations, “warning letters,” “untitled letters” or similar correspondence or notice from a Governmental Entity in respect of the business and no such action is pending oralleging or asserting noncompliance with any applicable Laws, Regulatory Permits, and, to the knowledge of the Company, no Governmental Entity is considering such action. (g) No pre-clinical studies or clinical trials in respect of the Products have been or are being conducted by or on behalf of the Company or its Subsidiaries. (h) None of the Company, its Subsidiaries, nor any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar Law. As of the date of this Agreement, no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the Company’s knowledge, threatened against the Company, its Subsidiaries, or any of their officers, employees or agents. (i) Except as set forth in writingSection 2.27(i) of the Company Disclosure Schedule, there have been no (i) recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Products (“Safety Notices”) since January 1, 2011. Neither Section 2.27(i) of the Company Disclosure Schedule lists (i) all such Safety Notices, (ii) the dates such Safety Notices, if any, were resolved or closed, and (iii) to the Company’s knowledge, any material complaints with respect to the products that are currently unresolved. To the Company’s knowledge, there have been no material product complaints with respect to the products, and there are no facts that would be reasonably likely to result in (i) a material Safety Notice with respect to the products, (ii) a change in the marketing 31 NY\7370590.17 classification or a material change in labeling of any of the products or (iii) a termination or suspension of marketing or testing of any of the products. (j) Since January 1, 2011, neither the Company nor any of its Subsidiaries has entered into any arrangement, and to the Company’s knowledge, no representative of the Company nor any of its Subsidiaries, acting on behalf of or at the direction of the Company or any of its subsidiaries: Subsidiaries, has entered into any arrangement relating to the Business involving the offering or paying of any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to any Person that is not reasonably believed by the Company to be subject to an applicable safe harbor or exception or that did or would violate the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b) (the “Anti-Kickback Statute”). There are no arrangements relating to the Business providing for any rebates, kickbacks or other forms of compensation that are not reasonably believed by the Company to be subject to an applicable safe harbor or exception or that would reasonably be expected to be determined to be unlawful to be paid to any Person in return for the referral or generation of business for the Company or the Subsidiaries or for the arrangement for recommendation of such referrals or business. (k) Except as set forth in Section 2.27(k) of the Company Disclosure Schedule, since January 1, 2011, all xxxxxxxx by the Company and its Subsidiaries for services of the Business and marketing practices in connection therewith, including xxxxxxxx to all federal and state healthcare programs (e.g., Medicare, Medicaid, Medicaid-waiver, TRICARE etc.), private individuals or patients, private or commercial third-party payors and third-party payors, have been true and correct and in compliance with all applicable Laws and Regulations, in each case, in all material respects, other than billing and payment reconciliations occurring in the ordinary course of business. Section 2.27(k) of the Company Disclosure Schedule sets forth all notices, subpoenas and material correspondence related to utilization, reimbursement or other government or third party audits or investigations targeted at the Company or any of its Subsidiaries or related to the Business, conducted since January 1, 2011, that are in the possession or control of the Company or any of its Subsidiaries. Except as permitted by Law or a third-party payor, none of the Company or any of its Subsidiaries has waived or discounted patient responsibility for any services. (l) Since January 1, 2011, to the knowledge of the Company, (i) is no physician or referring physician, as those terms are defined in the regulations promulgated pursuant to Section 1877 of the Social Security Act (42 U.S.C. Section 1395nn) (the “Xxxxx Law”), who has a party to “financial relationship,” as defined in the Xxxxx Law, whether direct or indirect investment or ownership interest or direct or indirect compensation arrangement (a “Financial Relationship”) with the Company or any of its Subsidiaries, who practices any medical specialty other than pathology and also makes (or has any reporting obligations under a corporate integrity agreementmade) referrals, deferred as that term is defined in the Xxxxx Law, of patients or non-prosecution agreement, monitoring agreement, consent decree, settlement order, or any similar agreement with any Governmental Authority; or specimen(s) to the Business and (ii) no physician or referring physician, as those terms are defined in the Xxxxx Law, having a Financial Relationship with the Company or any of its Subsidiaries, directly or indirectly, makes (or has made any submissions pursuant made) referrals, as that term is defined in the Xxxxx Law, of patients or services to the Office Business other than referrals which comply with, or are exempt from, the requirements of Inspector Generalthe Xxxxx Law, including because the Financial Relationship qualifies for an exception under the Xxxxx Law. The foregoing representation and warranty shall similarly be true and correct as it relates to any prohibition under any applicable state Laws and Regulations that are substantially similar to the Xxxxx Law. There are no financial 32 NY\7370590.17 relationships between the Company or any of its Subsidiaries or any of their respective directors, employees or Affiliates on behalf of the Company or any of its Subsidiaries, on the one hand, and any of the Company’s Self Disclosure Protocol or Centers any of its Subsidiaries’ clients and customers who make referrals for Medicare laboratory services to the Business relating to the Business, on the other hand, which are not in compliance with the Xxxxx Law, the Anti-Kickback Statute or other applicable Laws and Medicaid Services’ Self-Reporting Disclosure ProtocolRegulations.

Healthcare Regulatory Matters. Except as Without limiting the generality of Section 2.17 or Section 2.21: (ia) otherwise disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus or (ii) would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the The Company and each subsidiary is its Subsidiaries and their respective directors, officers, employees, and agents are, and at all times have been, in compliance with all Healthcare relevant health care Laws (as defined below) applicable to the business of the Company, relating to the compounding, development, manufacturing, labeling, advertising, promotion, storage and distribution of drug products and medical devices, or the operation or management of home and outpatient infusion centers, pharmacy, patient healthcare information, patient abuse, and the quality and adequacy of infusion or other medical care, including without limitation: (a) federal and state fraud and abuse lawsthem, including, without limitationbut not limited to, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Public Health Service Act (42 U.S.C. §§ 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. § 263a et seq.), the federal Anti-Kickback Anti- kickback Statute (42 U.S.C. §§ 1320a-7b(b)), the Sxxxx Law (42 U.S.C. §1395nn), the Civil civil False Claims Act (31 U.X.X. U.S.C. §0000 § 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the civil monetary penalty laws Anti-Inducement Law 29 NY\7370590.17 (42 U.S.C. § 1320a-7a1320a-7a(a)(5)), the exclusion laws (42 U.S.C. § 1320a-7), and any similar state laws or regulations, (b) 42 U.S.C. §§ 1395-1395lll (the Medicare Act), (c) Title XIX administrative simplification provisions of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 (the Medicaid Act), (d) the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and all regulations promulgated thereto, (e) the Food, Drug and Cosmetic Act (21 42 U.S.C. § 301 1320d et seq.), (f) the Public Health Service Act Xxxxx Law (42 U.S.C. § 201 et. seq.1395nn), the exclusion laws, SSA § 1128 (g) 42 U.S.C. 1320a-7), Medicare (Title XVIII of the Controlled Substances Act (21 U.S.C. § 801 et seq.Social Security Act), and any comparable healthcare laws, regulations each of Medicaid (a) through (g) as may be amended from time to time, and the regulations promulgated thereto (collectively, “Healthcare Laws”). Neither the Company nor any subsidiary is subject to material civil penalties, or mandatory or permissive exclusion from any state or federal healthcare program, including Medicare, Medicaid, TRICARE, CHAMPVA, any state health plan adopted pursuant to Title XIX of the Social Security Act Act), and the regulations promulgated pursuant to such Laws, and comparable state Laws, manual provisions, policies and administrative guidance and all other local, state, federal, national, supranational and foreign Laws relating to the regulation of the Company and its Subsidiaries (collectively, “Governmental ProgramHealth Care Laws”). Without limiting the generality None of the foregoing, neither the Company or any subsidiary its Subsidiaries has received written notice by a any notification, correspondence or any other communication from any Governmental Authority Entity of potential or actual non-compliance or liability under any Health Care Laws, or has knowledge of any material circumstances reasonably likely to constitute a violation (or of any actionHealth Care Law. (b) Each of the Company and its Subsidiaries meets all the requirements of participation and payment of any governmental health care program (collectively, litigation, arbitration, claim, demand, investigation, audit, charge, or formal inquiry (“ProceedingGovernment Health Care Programs”) involving allegations of any material violation) of any applicable Healthcare Lawsand third party payment program in which it participates (collectively, “Health Care Programs”), and is a party to valid participation agreements for payment by such Government Health Care Programs if the Company or its Subsidiaries, as applicable, bills a particular Government Health Care Program for services or procedures or is otherwise required to meet such requirements. There is no such Proceeding involving such allegations of any such material violation isLitigation pending, received or, to the knowledge of the Company, threatened against the Company or its Subsidiaries which relates in writing any way to a violation of any Health Care Law or contemplated, except where such Proceeding would not, individually other Law pertaining to the Government Health Care Programs or overpayments which could result in the aggregateimposition of penalties against or the exclusion of either or both of the Company or its Subsidiaries from participation in any Government Health Care Program or termination for cause of any managed care Contract under any Health Care Program. None of the Company nor any of its Subsidiaries or any of their respective officers or directors, reasonably be expected or, to have a Material Adverse Effect. For the past three (3) years knowledge of the Company, any of their respective employees or agents has engaged in any activity which is cause for civil penalties or mandatory or permissive exclusion from any Government Health Care Program. (c) Except as set forth in Section 2.27(c) of the Company Disclosure Schedule, none of the Company nor any Subsidiary is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. (d) The Company and its subsidiaries, its respective officers, directorsSubsidiaries have obtained and maintained each Permit, and employeesall supplements and amendments thereto filed with or issued or granted by, any Governmental Entity (including the FDA and any other Governmental Entity engaged in the regulation of the Business or the products sold or the tests offered by the Business (such products and tests, collectively, the “Products”)), required for the operation of the Business as currently conducted, the holding of any interest in any of its properties and assets, and the operation of its facilities (collectively, “Regulatory Permits”), and all of such Regulatory Permits are in full force and effect. Except as set forth in Section 2.27(d) of the Company Disclosure Schedule, none of the Company or any Subsidiary has received any communication from any Governmental Entity regarding, and, to the knowledge of the Company, there are no facts or circumstances that are likely to give rise to, (i) any material adverse change in any Regulatory Permit, or any failure to materially comply with any applicable Laws or any term or requirement of any Regulatory 30 NY\7370590.17 Permit or (ii) any revocation, withdrawal, suspension, cancellation, limitation, termination or material modification of any Regulatory Permit. (e) All applications, notifications, submissions, information, 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 Regulatory Permit from a Governmental Entity relating to the Company or its Licensed ProvidersSubsidiaries, the Business and the Products (if any), when submitted to such Governmental Entity were true, complete and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modification to such applications, submissions, information and data have been submitted to such Governmental Entity. No Permit from the FDA is required for the sale of Products and the Products and the packaging and labelling of the Products do not violate any FDA requirement. The claims made by the Company and its Subsidiaries with respect to the Products are not valid and supported by proper research, design, testing, analysis and disclosure (to the extent required by applicable Laws and Regulations) and such claims have not beenbeen disapproved or challenged by any Government Entity. (f) Except as set forth in Section 2.27(f) of the Company Disclosure Schedule, excludedduring the past five (5) years, debarredthe Company and its Subsidiaries have not had any manufacturing or laboratory site subject to a Governmental Entity shutdown or import or export prohibition, suspended or otherwise ineligible to participate in nor received any Governmental ProgramEntity notice of inspectional observations, “warning letters,” “untitled letters” or similar correspondence or notice from a Governmental Entity in respect of the business and no such action is pending oralleging or asserting noncompliance with any applicable Laws, Regulatory Permits, and, to the knowledge of the Company, no Governmental Entity is considering such action. (g) No pre-clinical studies or clinical trials in respect of the Products have been or are being conducted by or on behalf of the Company or its Subsidiaries. (h) None of the Company, its Subsidiaries, nor any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar Law. As of the date of this Agreement, no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the Company’s knowledge, threatened against the Company, its Subsidiaries, or any of their officers, employees or agents. (i) Except as set forth in writingSection 2.27(i) of the Company Disclosure Schedule, there have been no (i) recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Products (“Safety Notices”) since January 1, 2011. Neither Section 2.27(i) of the Company Disclosure Schedule lists (i) all such Safety Notices, (ii) the dates such Safety Notices, if any, were resolved or closed, and (iii) to the Company’s knowledge, any material complaints with respect to the products that are currently unresolved. To the Company’s knowledge, there have been no material product complaints with respect to the products, and there are no facts that would be reasonably likely to result in (i) a material Safety Notice with respect to the products, (ii) a change in the marketing 31 NY\7370590.17 classification or a material change in labeling of any of the products or (iii) a termination or suspension of marketing or testing of any of the products. (j) Since January 1, 2011, neither the Company nor any of its Subsidiaries has entered into any arrangement, and to the Company’s knowledge, no representative of the Company nor any of its Subsidiaries, acting on behalf of or at the direction of the Company or any of its subsidiaries: Subsidiaries, has entered into any arrangement relating to the Business involving the offering or paying of any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to any Person that is not reasonably believed by the Company to be subject to an applicable safe harbor or exception or that did or would violate the Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x) (the “Anti-Kickback Statute”). There are no arrangements relating to the Business providing for any rebates, kickbacks or other forms of compensation that are not reasonably believed by the Company to be subject to an applicable safe harbor or exception or that would reasonably be expected to be determined to be unlawful to be paid to any Person in return for the referral or generation of business for the Company or the Subsidiaries or for the arrangement for recommendation of such referrals or business. (k) Except as set forth in Section 2.27(k) of the Company Disclosure Schedule, since January 1, 2011, all xxxxxxxx by the Company and its Subsidiaries for services of the Business and marketing practices in connection therewith, including xxxxxxxx to all federal and state healthcare programs (e.g., Medicare, Medicaid, Medicaid-waiver, TRICARE etc.), private individuals or patients, private or commercial third-party payors and third-party payors, have been true and correct and in compliance with all applicable Laws and Regulations, in each case, in all material respects, other than billing and payment reconciliations occurring in the ordinary course of business. Section 2.27(k) of the Company Disclosure Schedule sets forth all notices, subpoenas and material correspondence related to utilization, reimbursement or other government or third party audits or investigations targeted at the Company or any of its Subsidiaries or related to the Business, conducted since January 1, 2011, that are in the possession or control of the Company or any of its Subsidiaries. Except as permitted by Law or a third-party payor, none of the Company or any of its Subsidiaries has waived or discounted patient responsibility for any services. (l) Since January 1, 2011, to the knowledge of the Company, (i) is no physician or referring physician, as those terms are defined in the regulations promulgated pursuant to Section 1877 of the Social Security Act (42 U.S.C. Section 1395nn) (the “Xxxxx Law”), who has a party to “financial relationship,” as defined in the Xxxxx Law, whether direct or indirect investment or ownership interest or direct or indirect compensation arrangement (a “Financial Relationship”) with the Company or any of its Subsidiaries, who practices any medical specialty other than pathology and also makes (or has any reporting obligations under a corporate integrity agreementmade) referrals, deferred as that term is defined in the Xxxxx Law, of patients or non-prosecution agreement, monitoring agreement, consent decree, settlement order, or any similar agreement with any Governmental Authority; or specimen(s) to the Business and (ii) no physician or referring physician, as those terms are defined in the Xxxxx Law, having a Financial Relationship with the Company or any of its Subsidiaries, directly or indirectly, makes (or has made any submissions pursuant made) referrals, as that term is defined in the Xxxxx Law, of patients or services to the Office Business other than referrals which comply with, or are exempt from, the requirements of Inspector Generalthe Xxxxx Law, including because the Financial Relationship qualifies for an exception under the Xxxxx Law. The foregoing representation and warranty shall similarly be true and correct as it relates to any prohibition under any applicable state Laws and Regulations that are substantially similar to the Xxxxx Law. There are no financial 32 NY\7370590.17 relationships between the Company or any of its Subsidiaries or any of their respective directors, employees or Affiliates on behalf of the Company or any of its Subsidiaries, on the one hand, and any of the Company’s Self Disclosure Protocol or Centers any of its Subsidiaries’ clients and customers who make referrals for Medicare laboratory services to the Business relating to the Business, on the other hand, which are not in compliance with the Xxxxx Law, the Anti-Kickback Statute or other applicable Laws and Medicaid Services’ Self-Reporting Disclosure ProtocolRegulations.