Common use of Compliance with Health Care Laws Clause in Contracts

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, and the regulations promulgated pursuant to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where the Company or any of its subsidiaries conducts business. Additionally, neither the Company, nor, to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) all health care laws applicable to the United States Company, including, but not limited to: the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section §§ 301 et seq), the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Physician Payment Sunshine Act (42 U.S.C. § 1320a-7h), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.) ), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the regulations promulgated thereunder; (ii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.) ), the exclusion laws (“42 U.S.C. § 1320a-7), HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other similar state, local, federal or foreign health care laws and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) federal, state, local and foreign health care related fraud and abuse pursuant to such laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA’s current good manufacturing practice regulations at 21 CFR Part 820 and all other laws and regulations applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of the Company’s products, each as amended from time to time. Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the U.S. Civil False Claims Act Company (31 U.S.C. Section 3729 et seq.)i) is and at all times has been in compliance with all Health Care Laws and has not engaged in activities which are, the as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnfrom Medicare, and the regulations promulgated pursuant to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunderMedicaid, or any other state or federal health care program; and (viiii) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice from any court or arbitrator or governmental or regulatory authority alleging or asserting noncompliance with (x) any Health Care Laws or (y) any Governmental Licenses required by any such Health Care Laws. Except as would not, singly or in the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Governmental Licenses and all other applicable health care laws such reports, documents, forms, notices, applications, records, claims, submissions and regulationssupplements or amendments were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission). Except as would not, singly or in any jurisdiction where the aggregate, reasonably be expected to result in a Material Adverse Effect, the Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging a violation of its subsidiaries conducts businessany Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company is not a party to and has no ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Entity. Additionally, neither the CompanyCompany nor any of its employees, norofficers, directors, or, to the knowledge of the Company, any of its employeesagents, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical trial or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companyreasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable compliance in all material respects with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws criminal False Statements Law (42 U.S.C. Section 1320a-7 1320a-7b(a)), 18 U.S.C. Sections 286, 287, 1035, 1347, and 1349 the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1395nn1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and the regulations promulgated pursuant to such statutesClinical Health Act (42 U.S.C. Section 17921 et seq.); (iv) the U.S. Controlled Substances ActPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) Titles XVIII licensure, quality, safety and XIX of the U.S. Social Security Act accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and the regulations promulgated thereunder; (vi) all other local, state, federal, national, supranational and foreign laws, relating to the Clinical Laboratory Improvement Amendments and regulation of the regulations promulgated thereunder; Company or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes and any and all other applicable health care laws and regulationsstate or non-U.S. counterpart thereof. Neither the Company, any of its subsidiaries, nor any of their respective officers, directors, employees or agents have engaged in any jurisdiction where activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company, and to the Company’s knowledge, its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company, any of its subsidiaries, nor, to the Company’s knowledge, any of their respective employees, officers, directors, or agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any compliance in all material respects with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a et seq.), the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws criminal False Statements Law (42 U.S.C. Section 1320a-7 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion laws, laws governing government funded or sponsored healthcare programs, and the directives and regulations promulgated pursuant to such statutesstatutes and any state or non-U.S. counterpart thereof; (iii) HIPAA, as amended by the HITECH Act (42 U.S.C. Section 17921 et seq.); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII Patient Protection and XIX Affordable Care Act of 2010, as amended by the U.S. Social Security Health Care and Education Affordability Reconciliation Act and of 2010, the regulations promulgated thereunder; (viv) the Clinical Laboratory Improvement Amendments licensure, quality, safety and the regulations promulgated thereunderaccreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (viivi) any and all other applicable health care laws local, state, federal, national, supranational and regulationsforeign laws, in any jurisdiction where relating to the regulation of the Company or its subsidiaries. Neither the Company, any of its subsidiaries, nor to the Company’s knowledge, any of its officers, directors, employees or agents have engaged in activities which are, as applicable, cause for material liability under a Health Care Law. Neither the Company nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging a material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any material compliance with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Health Insurance Portability and Accountability Act of 1996 Anti-Kickback Statute (42 U.S.C. Section 1320d 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under HIPAA, the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320 7h), and applicable laws governing government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, thereunder and any comparable applicable state privacy and security laws ; (iii) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the or non-U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, and the regulations promulgated pursuant to such statutes)counterpart thereof; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII Patient Protection and XIX Affordable Care Act of 2010, as amended by the U.S. Social Security Health Care and Education Reconciliation Act of 2010, and the regulations promulgated thereunder; (viv) the Clinical Laboratory Improvement Amendments licensure, quality, safety and the regulations promulgated thereunder; and (vii) any and all other accreditation requirements under applicable health care federal, state, local or foreign laws and regulations, in any jurisdiction where or regulatory bodies. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companyreasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expectedWithout limiting the generality of Section 2(n), individually or in neither the aggregate, to have a Material Adverse Effect, the Company, Company nor any of its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directorsemployees, officers, employees or other third parties acting on behalf directors and agents, nor any of or at the direction of the Company are not their respective business operations, is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder, including the U.S. Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section Sections 1320a-7 and 1320a-7a of Title 42 U.S.C. Section 1395nn, of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII any laws or regulations that govern participation in or coverage or reimbursement from any U.S. or state health care program, including but not limited to the federal TRICARE statute (10 U.S.C. §1071 et seq.), the Veterans Administration drug pricing program (38 U.S.C. Section 8126), and XIX of the U.S. Social Security Act and the any regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments quality, safety and the regulations promulgated thereunderaccreditation standards and requirements of any applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable health care laws and regulations, regulations in any jurisdiction where the Company or any of its subsidiaries conducts businessjurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company, nor, to the knowledge of the Company, Company nor any of its employees, officers, directors directors, agents or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws contractors has been excluded, suspended or debarred from participation in any federal health care program or or, to the knowledge of Company, is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would could subject the Company, Company or any of its employees, officers, directors directors, agents or other third parties acting on behalf of or at the direction of the Company, contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as Neither the Company nor any of its subsidiaries is in violation of any Health Care Laws, except where the failure to be in compliance would not reasonably be expectednot, individually or in the aggregate, to reasonably be expected have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, ) and the regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances ActAct (21 U.S.C. Section 801 et seq.); and (v) Titles XVIII quality, safety and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other accreditation requirements under applicable health care federal, state, local or foreign laws and regulations, in any jurisdiction where the Company or any of its subsidiaries conducts businessregulatory bodies. Additionally, neither the CompanyCompany nor any of its subsidiaries, nor, to the knowledge of the Company, any of its their respective employees, officers, officers or directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company and its subsidiaries, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject reasonably be expected to result in debarment, suspension, or exclusion. Any certificate signed by any officer of the Company, Company or any of its employeessubsidiaries and delivered to the Underwriter or to counsel for the Underwriter in connection with the offering, officersor the purchase and sale, directors or other third parties acting on behalf of or at the direction of the CompanyOffered Shares shall be deemed a representation and warranty by the Company to the Underwriter as to the matters covered thereby. The Company has a reasonable basis for making each of the representations set forth in this Section 1A. The Company acknowledges that the Underwriter and, for purposes of the opinions to exclusionbe delivered pursuant to Section 6 hereof, suspension or debarmentcounsel to the Company and counsel to the Underwriter, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. Except as Neither the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected, individually or expected to result in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, Food Drug and Cosmetic Act (21 U.S.C. Section §§ 301 et seq.) and the regulations promulgated thereunder); (ii) the U.S. federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes; (iii) the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”Pub. L. No. 104-191), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.)Health, and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, Medicare (Title XVIII of the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, Social Security Act) and the regulations promulgated pursuant to such statutes); (iv) the U.S. Controlled Substances Actthereunder; (v) Titles XVIII and Medicaid (Title XIX of the U.S. Social Security Act Act) and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations promulgated thereunderrelating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federal, state, or foreign health care laws and or regulations, in any jurisdiction where including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or any of its subsidiaries conducts business. Additionally, neither warranties regarding compliance by the Company, nor, to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication ’s physician customers with an inquiry, investigation, proceeding, or other similar matter that would subject the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarmentapplicable laws.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, The Company and its subsidiaries, subsidiaries and, to the knowledge of the Company, the Company’s knowledge, their respective directors, employees and agents (while acting in such capacity) are in material compliance with, all health care laws applicable to the Company and its subsidiaries’ directors, officersor any of its products or activities, employees or other third parties acting on behalf of or at including, but not limited to, the direction of federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Company are not in violation of any applicable Health Care Laws. For purposes of this AgreementAnti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Xxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, advertising, marketing or distribution of drugs and foreign medical devices (including diagnostic products), kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). Neither the Company nor its subsidiaries has received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute FDA, the EMEA, Health Canada, the United States Federal Trade Commission, the United States Drug Enforcement Administration (42 U.S.C. Section 1320a-7b(b)“DEA”), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.)CMS, HHS’s Office of Inspector General, the exclusion laws (42 U.S.C. Section 1320a-7 United States Department of Justice and 42 U.S.C. Section 1395nnstate Attorneys General or similar agencies of potential or actual non-compliance by, and or liability of, the regulations promulgated pursuant Company under any Health Care Laws, except, with respect to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, in any jurisdiction where the Company or any of its subsidiaries conducts businessreasonably be expected to have a Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating and its subsidiaries under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company’s and its subsidiaries’ compliance therewith included in the Preliminary Prospectus, or any in the Time of its employees, officers, directors or other third parties acting on behalf of or at Sale Disclosure Package and in the direction of Prospectus fairly summarize the Company, to exclusion, suspension or debarmentmatters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expectedThe Company is, individually or and at all times has been, in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any material compliance with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. Section 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), all applicable federal, state, local and all foreign criminal laws relating to health care fraud and abuse, including but not limited to the U.S. False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iii) to the extent applicable, the Standards for Privacy of Individually Identifiable Health Information (the “HIPAAPrivacy Rule”), as amended by the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, thereunder and any comparable state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy and security laws ; (iii) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, and the regulations promulgated pursuant to such statutes)of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII Patient Protection and XIX Affordable Care Act of 2010, as amended by the U.S. Social Security Health Care and Education Reconciliation Act and of 2010, the regulations promulgated thereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) the Clinical Laboratory Improvement Amendments licensure, quality, safety and the regulations promulgated thereunderaccreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other material action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all other applicable health care laws such reports, documents, forms, notices, applications, records, claims, submissions and regulationssupplements or amendments were in all material respects timely, in complete, accurate and not misleading on the date filed (or were corrected or supplemented by a subsequent submission). The Company is not a party to any jurisdiction where the Company corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any of its subsidiaries conducts businessgovernmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, Company nor any of its employees, officers, officers or directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as described in the Registration Statement and the Prospectus, the Company and its subsidiaries are, and at all times have been, in compliance with all applicable Health Care Laws, except to the extent that any non-compliance would not reasonably be expectednot, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care LawsChange. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national, supranational and foreign health care related fraud and abuse laws, including, without limitation, relating to the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), regulation of the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCompany or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Change. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor, to the knowledge of the Company, any of its their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject could reasonably be expected to result in debarment, suspension, or exclusion. Any certificate signed by any officer or representative of the Company, Company or any of its employeessubsidiaries and delivered to the Agent or counsel for the Agent in connection with an issuance of Shares shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby on the date of such certificate. The Company acknowledges that the Agent and, officers, directors or other third parties acting on behalf of or at the direction for purposes of the Companyopinions to be delivered pursuant to Section 4(o) hereof, counsel to exclusionthe Company and counsel to the Agent, suspension or debarmentwill rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any compliance in all material respects with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a et seq.), the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn1320a-7), laws governing government funded or sponsored healthcare programs, and the directives and regulations promulgated pursuant to such statutesstatutes and any state or non-U.S. counterpart thereof; (iii) HIPAA, as amended by the HITECH Act (42 U.S.C. Section 17921 et seq.); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII Patient Protection and XIX Affordable Care Act of 2010, as amended by the U.S. Social Security Health Care and Education Affordability Reconciliation Act and of 2010, the regulations promulgated thereunder; (viv) the Clinical Laboratory Improvement Amendments licensure, quality, safety and the regulations promulgated thereunderaccreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (viivi) any and all other applicable health care laws local, state, federal, national, supranational and regulationsforeign laws, in any jurisdiction where relating to the regulation of the Company or its subsidiaries. Neither the Company, any of its subsidiaries, nor to the Company’s knowledge, any of its officers, directors, employees or agents have engaged in activities which are, as applicable, cause for material liability under a Health Care Law. Neither the Company nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging a material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company, any of its subsidiaries, nor any of their respective employees, officers, directors, or, to the Company’s knowledge, agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would The Company and its subsidiaries are in material compliance with all applicable Health Care Laws, except where such failure or violation could not reasonably be expected, individually or in the aggregate, to have result in a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care LawsChange. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Health Insurance Portability Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and Accountability Act of 1996 287, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local and or foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute laws or regulatory bodies; (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, vi) and the directives and regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any applicable Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national, supranational and foreign health care related fraud and abuse laws, including, without limitation, relating to the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), regulation of the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCompany or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as Neither the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected, individually or expected to result in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Foodfederal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, Drugincluding, and Cosmetic but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the Xxxxx Law (42 U.S.C. § 1395nn), the civil False Claims Act (21 31 U.S.C. Section 301 § 3729 et seq.) ), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated thereunderpursuant to such statutes; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.Pub. L. No. 104-191) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, Medicare (Title XVIII of the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, Social Security Act) and the regulations promulgated pursuant to such statutes)thereunder; (iv) Medicaid (Title XIX of the U.S. Controlled Substances Social Security Act) and the regulations promulgated thereunder; (v) Titles XVIII the Medicare Prescription Drug, Improvement, and XIX Modernization Act of the U.S. Social Security Act 2003 (Pub. L. No. 108-173) and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments quality, safety and the regulations promulgated thereunderaccreditation requirements of all applicable state laws or regulatory bodies; and (vii) any and all other applicable federal, state, or foreign health care laws and or regulations, in any jurisdiction where each of (i) through (vii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or any of its subsidiaries conducts business. Additionally, neither warranties regarding compliance by the Company, nor, to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication ’s physician customers with an inquiry, investigation, proceeding, or other similar matter that would subject the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarmentapplicable laws.

Compliance with Health Care Laws. Except as The Company is, and at all times has been, in compliance with all Health Care Laws, except for any noncompliance that would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), all applicable federal, state, local and all foreign criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the exclusion laws health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320a-7 1320d et seq.), the exclusion laws, the statutes, regulations and 42 U.S.C. Section 1395nndirectives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII Patient Protection and XIX Affordable Care Act of 2010, as amended by the U.S. Social Security Health Care and Education Affordability Reconciliation Act and of 2010, the regulations promulgated thereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) the Clinical Laboratory Improvement Amendments quality, safety and the regulations promulgated thereunderaccreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Event, the Company has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all other applicable health care laws such reports, documents, forms, notices, applications, records, claims, submissions and regulationssupplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). The Company is not a party to any corporate integrity agreements, in monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any jurisdiction where the Company governmental or any of its subsidiaries conducts businessregulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, Company nor any of its employees, officers, officers or directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or disclosed in the aggregate, to have a Material Adverse EffectRegistration Statement, the CompanyPricing Disclosure Package or the Prospectus, the Company and its subsidiariessubsidiaries are, andand at all times have been, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable material compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), all applicable federal, state, local and all foreign criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the exclusion laws health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320a-7 1320d et seq.), the exclusion laws, the statutes, regulations and 42 U.S.C. Section 1395nndirectives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII Patient Protection and XIX Affordable Care Act of 2010, as amended by the U.S. Social Security Health Care and Education Affordability Reconciliation Act and of 2010, the regulations promulgated thereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) the Clinical Laboratory Improvement Amendments quality, safety and the regulations promulgated thereunderaccreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable health care laws local, state, federal, national, supranational and regulationsforeign laws, in any jurisdiction where relating to the regulation of the Company or any of its subsidiaries. Neither the Company nor its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, neither the Company, its subsidiaries nor any of its their respective employees, officers, officers or directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Sxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, advertising, marketing or distribution of drugs and foreign medical devices (including diagnostic products), kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute FDA, the EMEA, Health Canada, the United States Federal Trade Commission, the United States Drug Enforcement Administration (42 U.S.C. Section 1320a-7b(b)“DEA”), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.)CMS, HHS’s Office of Inspector General, the exclusion laws (42 U.S.C. Section 1320a-7 United States Department of Justice and 42 U.S.C. Section 1395nnstate Attorneys General or similar agencies of potential or actual non-compliance by, and or liability of, the regulations promulgated pursuant Company under any Health Care Laws, except, with respect to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, in any jurisdiction where the Company or any of its subsidiaries conducts businessreasonably be expected to have a Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at ’s compliance therewith included in the direction of Preliminary Prospectus and in the Company, to exclusion, suspension or debarmentProspectus fairly summarize the matters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expectedThe Company and its subsidiaries are, individually or and at all times have been, in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, compliance in all material respects with all Health Care Laws to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of extent applicable to the Company are not in violation or any of any applicable Health Care Lawsits subsidiaries or their respective businesses. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the Public Health Service Act, and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws criminal False Statements Law (42 U.S.C. Section 1320a-7 1320a-7b(a)), 18 U.S.C. Sections 286, 287, 1035, and 1349, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1395nn1320d et seq.), and the regulations promulgated pursuant to such statutescivil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the HITECH Act, (42 U.S.C. Section 17921 et seq.); (iv) the U.S. Controlled Substances ActPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) Titles XVIII licensure, quality, safety and XIX of the U.S. Social Security Act and the regulations promulgated thereunderaccreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws local, state, federal, national, supranational and regulationsforeign laws, in any jurisdiction where relating to the regulation of the Company or any of its subsidiaries conducts businesssubsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Additionally, neither Neither the Company, norany of its subsidiaries, nor any of their respective officers, directors, employees and, to the knowledge of the CompanyCompany and each of its subsidiaries, any of their respective agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s or any of its subsidiaries’ knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. None of the Company nor any of its subsidiaries nor their respective employees, officers, directors directors, or, to the knowledge of the Company or other third parties acting any of its subsidiaries, their respective agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority related to activities conducted by or on behalf of the Company or at the direction any of its subsidiaries. Additionally, none of the Company in matters relating nor any of its subsidiaries nor their respective employees, officers, directors, or, to the Health Care Laws knowledge of the Company or any of its subsidiaries, their respective agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company or any of its subsidiaries, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national, supranational and foreign health care related fraud and abuse laws, relating to the regulation of the Company or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and each of the subsidiaries possess all licenses, certificates, authorizations and permits issued by, and have made all declarations and filings with, the appropriate local, state, federal or foreign regulatory agencies or bodies (including, without limitation, those administered by the U.S. Anti-Kickback Statute FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) which are necessary for the ownership of their respective properties or the conduct of their respective businesses (42 U.S.C. Section 1320a-7b(b))collectively, the U.S. Civil False Claims Act “Governmental Authorizations”). The Company and the subsidiaries are in material compliance with all such Governmental Authorizations and all such Governmental Authorizations are valid and in full force. Neither the Company nor any Subsidiary has received written notification of any revocation, modification, suspension, termination or invalidation (31 U.S.C. Section 3729 et seq.)or proceedings related thereto) of any such Governmental Authorizations and to the knowledge of the Company, no event has occurred that allows or results in, or after notice or lapse of time or both would allow or result in, revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Authorization and the exclusion laws (42 U.S.C. Section 1320a-7 Company has no reason to believe that any such Governmental Authorization will not be renewed. The Company and 42 U.S.C. Section 1395nnits subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws and Governmental Authorizations, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the regulations promulgated pursuant to such statutesdate filed in all material respects (or were corrected or supplemented by a subsequent submission); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where . Neither the Company or nor any of its subsidiaries conducts businessis a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as The Company is, and at all times has been, in compliance with all Health Care Laws, except for any noncompliance that would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), all applicable federal, state, local and all foreign criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the exclusion laws health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320a-7 1320d et seq.), the exclusion laws, the statutes, regulations and 42 U.S.C. Section 1395nndirectives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII Patient Protection and XIX Affordable Care Act of 2010, as amended by the U.S. Social Security Health Care and Education Affordability Reconciliation Act and of 2010, the regulations promulgated thereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) the Clinical Laboratory Improvement Amendments quality, safety and the regulations promulgated thereunderaccreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company. The Company has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect, the Company has filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all other applicable health care laws such reports, documents, forms, notices, applications, records, claims, submissions and regulationssupplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). The Company is not a party to any corporate integrity agreements, in monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any jurisdiction where the Company governmental or any of its subsidiaries conducts businessregulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, Company nor any of its employees, officers, officers or directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable material compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vi) the collection and foreign health care related fraud reporting requirements, and abuse lawsthe processing of any applicable rebate, includingchargeback or adjustment, without limitation, under applicable rules and regulations relating to the U.S. Anti-Kickback Statute Medicaid Drug Rebate Program (42 U.S.C. Section 1320a-7b(b)§ 1396r-8) and any state supplemental rebate program, state drug price transparency law , Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the U.S. Civil False Claims Public Health Service Act (31 42 U.S.C. Section 3729 § 256b), the federal TRICARE program (10 U.S.C. §§ 1071 et seq.), the exclusion laws VA Federal Supply Schedule (42 38 U.S.C. Section 1320a-7 § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, (vii) all other local, state, federal, national, supranational and 42 U.S.C. Section 1395nnforeign laws, relating to the regulation of the Company or its subsidiaries, and (viii) the directives and regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expectedWithout limiting the generality of subsection 1(a)(47) above, individually or in neither the aggregate, to have a Material Adverse Effect, the Company, Company nor any of its subsidiaries, andnor any of their respective officers, nor, to the knowledge of the Company, any of their respective employees, directors, agents, contractors or licensees (if any), nor, to the Company’s and its subsidiaries’ directorsknowledge, officersany of their respective business operations, employees or other third parties acting on behalf of or at the direction of the Company are not is in violation of any applicable Health Care Laws, except where the failure to be in compliance would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all federal, state, local and all foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Xxxxx Law (42 U.S.C. Section 1395nn), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section Sections 1320a-7 and 1320a-7a of Title 42 U.S.C. Section 1395nn, of the United States Code and the regulations promulgated pursuant to such statutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, the Standards for Electronic Transactions and Code Sets promulgated under HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (vvii) Titles XVIII quality, safety and XIX accreditation standards and requirements of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunderany applicable federal, state, local or foreign laws or regulatory bodies; and (viiviii) any and all other applicable health care laws and laws, regulations, manual provisions, policies and administrative guidance in any jurisdiction where the Company or any of its subsidiaries conducts businessjurisdiction, as well as contractual agreements mandated by such laws. Additionally, neither the Company, nor, to the knowledge of the Company, Company nor any of its subsidiaries, nor any of their respective employees, officers, directors directors, agents or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws contractors has been excluded, suspended or debarred from participation in any federal health care program or or, to the knowledge of the Company and its subsidiaries, is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would could subject the Company, any of its subsidiaries, or any of its their respective employees, officers, directors directors, agents or other third parties acting on behalf of or at the direction of the Company, contractors to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Sxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, advertising, marketing or distribution of drugs and foreign medical devices (including diagnostic products), kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute FDA, the EMEA, Health Canada, the United States Federal Trade Commission, the United States Drug Enforcement Administration (42 U.S.C. Section 1320a-7b(b)“DEA”), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.)CMS, HHS’s Office of Inspector General, the exclusion laws (42 U.S.C. Section 1320a-7 United States Department of Justice and 42 U.S.C. Section 1395nnstate Attorneys General or similar agencies of potential or actual non-compliance by, and or liability of, the regulations promulgated pursuant Company under any Health Care Laws, except, with respect to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, in any jurisdiction where the Company or any of its subsidiaries conducts businessreasonably be expected to have a Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at ’s compliance therewith included in the direction of SEC Filings fairly summarize the Company, to exclusion, suspension or debarmentmatters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have been in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a 7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a 7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a 7b(a)), the U.S. Xxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a 7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the EMA, the TGA, Health Canada, the U.S. Civil False Claims Act Federal Trade Commission, the U.S. Drug Enforcement Administration (31 U.S.C. Section 3729 et seq.“DEA”), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCMS, and the regulations promulgated pursuant to such statutes); (iv) HHS’s Office of Inspector General, the U.S. Controlled Substances Act; (v) Titles XVIII Department of Justice and XIX state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, result in any jurisdiction where the Company or any of its subsidiaries conducts businessa Material Adverse Change. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at ’s compliance therewith included in the direction of Registration Statement and the Company, to exclusion, suspension or debarmentProspectus fairly summarize the matters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Sxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, advertising, marketing or distribution of drugs and foreign medical devices (including diagnostic products), kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute FDA, the EMEA, Health Canada, the United States Federal Trade Commission, the United States Drug Enforcement Administration (42 U.S.C. Section 1320a-7b(b)“DEA”), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.)CMS, HHS’s Office of Inspector General, the exclusion laws (42 U.S.C. Section 1320a-7 United States Department of Justice and 42 U.S.C. Section 1395nnstate Attorneys General or similar agencies of potential or actual non-compliance by, and or liability of, the regulations promulgated pursuant Company under any Health Care Laws, except, with respect to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, in any jurisdiction where the Company or any of its subsidiaries conducts businesshave a Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company’s compliance therewith included in the Preliminary Prospectus, or any in the Time of its employees, officers, directors or other third parties acting on behalf of or at Sale Disclosure Package and in the direction of Prospectus fairly summarize the Company, to exclusion, suspension or debarmentmatters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have been in compliance in all material respects with all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Sxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the EMA, Health Canada, the U.S. Civil False Claims Act Federal Trade Commission, the U.S. Drug Enforcement Administration (31 U.S.C. Section 3729 et seq.“DEA”), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCMS, and the regulations promulgated pursuant to such statutes); (iv) HHS’s Office of Inspector General, the U.S. Controlled Substances Act; (v) Titles XVIII Department of Justice and XIX state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, result in any jurisdiction where the Company or any of its subsidiaries conducts businessa Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company’s compliance therewith included in the Preliminary Prospectus, or any in the Time of its employees, officers, directors or other third parties acting on behalf of or at Sale Disclosure Package and in the direction of Prospectus fairly summarize in all material respects the Company, to exclusion, suspension or debarmentmatters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or The Company and its subsidiaries are in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, material compliance with all Health Care Laws to the knowledge of the Company, extent applicable to the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Lawsoperations. For purposes of this Agreement, “Health Care Laws” means means, to the extent applicable to the Company’s operations: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies and foreign health care related fraud (vi) the directive and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, and the regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, Company nor, to the knowledge of the Company’s knowledge, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as The Company and its subsidiaries are, and at all times have been, in compliance with all Health Care Laws, except where failure to be so in compliance would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Laws (42 U.S.C. Section 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), all applicable federal, state, local and foreign criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 1320a-7), the statutes, regulations and 42 U.S.C. Section 1395nndirectives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iii) the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h); (iv) HIPAA, as amended by the U.S. Controlled Substances ActHealth Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the data privacy and security regulations promulgated thereunder; (v) Titles XVIII the Patient Protection and XIX Affordable Care Act of 2010 (Pub. Law 111-148), as amended by the U.S. Social Security Health Care and Education Affordability Reconciliation Act and of 2010 (Pub. Law 111-152), the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vii) quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies, including, but not limited to, all laws applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the regulations promulgated thereunderCompany; and (viiviii) any and all other applicable health care laws local, state, federal, national, supranational and regulationsforeign laws, in any jurisdiction where relating to the regulation of the Company or any of its subsidiaries. Neither the Company nor its subsidiaries conducts businesshave received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect, the Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor its subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, its subsidiaries nor any of its their respective employees, officers, officers or directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companyreasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have been in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Xxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes legally binding requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the EMA, Health Canada, the U.S. Civil False Claims Act Federal Trade Commission, the U.S. Drug Enforcement Administration (31 U.S.C. Section 3729 et seq.“DEA”), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCMS, and the regulations promulgated pursuant to such statutes); (iv) HHS’s Office of Inspector General, the U.S. Controlled Substances Act; (v) Titles XVIII Department of Justice and XIX state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, result in any jurisdiction where the Company or any of its subsidiaries conducts businessa Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at ’s compliance therewith included in the direction of Registration Statement and in the Company, to exclusion, suspension or debarmentProspectus fairly summarize the matters therein described.

Compliance with Health Care Laws. Except as The Company and its subsidiaries are and at all times have been, in compliance with all applicable Health Care Laws, except where failure to be in compliance would not be expected reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the Public Health Service Act and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 § 1320a-7), the statutes, regulations and 42 U.S.C. Section 1395nndirectives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII Patient Protection and XIX Affordable Care Act of 2010, as amended by the U.S. Social Security Health Care and Education Affordability Reconciliation Act and of 2010, the regulations promulgated thereunder; (viv) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunderU.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); and (viivi) any and all other applicable health care laws and regulations, in any jurisdiction where the . The Company or any of and its subsidiaries conducts businesshave not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. The Company and its subsidiaries are not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, Company nor any of its subsidiaries nor any of their employees, officers, officers or directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as The Company and its subsidiaries are, and at all times have been, in compliance with all Health Care Laws applicable to the Company, its subsidiaries or their respective product candidates or activities, except where failure to be so in compliance have not, and would not reasonably be expectedexpected to have, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (collectively, “HIPAA”) (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national, supranational and foreign health care related fraud and abuse laws, including, without limitation, relating to the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), regulation of the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCompany or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or, to the Company’s knowledge, any other third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened, except in each case as would not, individually or in the aggregate, have a Material Adverse Effect. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor, to the knowledge of the Company, any of its their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companyreasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Public Health Information Technology for Economic and Clinical Health Service Act (42 U.S.C. Section 17921 201 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiii) all applicable federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws criminal false statements law (42 U.S.C. Section 1320a-7 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the regulations promulgated pursuant to such statutesHealth Information Technology for Economic and Clinical Health Act, HITECH (42 U.S.C. Section 17921 et seq.); (iv) the U.S. Controlled Substances ActPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) Titles XVIII licensure, quality, safety and XIX of the U.S. Social Security Act and the regulations promulgated thereunderaccreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vi) all other local, state, federal, national, supranational and foreign laws, relating to the Clinical Laboratory Improvement Amendments and regulation of the regulations promulgated thereunder; Company or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes and any and all other applicable health care laws and regulations, in any jurisdiction where state or non-U.S. counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any federal and/or state court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries, nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as Neither the Company nor any of its subsidiaries is in violation of any Health Care Laws, except where the failure to be in compliance would not reasonably be expectednot, individually or in the aggregate, to reasonably be expected have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, ) and the regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances ActAct (21 U.S.C. Section 801 et seq.); and (v) Titles XVIII quality, safety and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other accreditation requirements under applicable health care federal, state, local or foreign laws and regulations, in any jurisdiction where the Company or any of its subsidiaries conducts businessregulatory bodies. Additionally, neither the CompanyCompany nor any of its subsidiaries, nor, to the knowledge of the Company, any of its their respective employees, officers, officers or directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company and its subsidiaries, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject reasonably be expected to result in debarment, suspension, or exclusion. Any certificate signed by any officer of the Company, Company or any of its employeessubsidiaries and delivered to any Underwriter or to counsel for the Underwriters in connection with the offering, officersor the purchase and sale, directors or other third parties acting on behalf of or at the direction of the CompanyOffered Shares shall be deemed a representation and warranty by the Company to each Underwriter as to the matters covered thereby. The Company has a reasonable basis for making each of the representations set forth in this Section 1A. The Company acknowledges that the Underwriters and, for purposes of the opinions to exclusionbe delivered pursuant to Section 6 hereof, suspension or debarmentcounsel to the Company and counsel to the Underwriters, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. Except as would not reasonably be expectednot, individually or in the aggregate, to have result in a Material Adverse Effect, the Company, its subsidiaries, Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have operated in compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Sxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law or regulation, which imposes requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any written notification, correspondence or any other written or oral communication of any pending or threatened claim, suit, proceeding, hearing, enforcement action, investigation, arbitration or other action from any regulatory authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the EMA, Health Canada, the U.S. Civil False Claims Act Federal Trade Commission, the U.S. Drug Enforcement Administration (31 U.S.C. Section 3729 et seq.“DEA”), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCMS, and the regulations promulgated pursuant to such statutes); (iv) HHS’s Office of Inspector General, the U.S. Controlled Substances Act; (v) Titles XVIII Department of Justice and XIX state Attorneys General or similar agencies of any alleged non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, result in any jurisdiction where the Company or any of its subsidiaries conducts businessa Material Adverse Effect. Additionally, neither the Company, nor, The statements with respect to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company’s compliance therewith included in the Preliminary Prospectus, or any in the Time of its employees, officers, directors or other third parties acting on behalf of or at Sale Disclosure Package and in the direction of Prospectus fairly summarize the Company, to exclusion, suspension or debarmentmatters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the Sxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national, supranational and foreign health care related fraud and abuse laws, including, without limitation, relating to the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), regulation of the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCompany or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject could reasonably be expected to result in debarment, suspension, or exclusion. Any certificate signed by any officer or representative of the Company, Company or any of its employeessubsidiaries and delivered to the Agent or counsel for the Agent in connection with an issuance of Shares shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby on the date of such certificate. The Company acknowledges that the Agent and, officers, directors or other third parties acting on behalf of or at the direction for purposes of the Companyopinions to be delivered pursuant to ‎Section 4(o) hereof, counsel to exclusionthe Company and counsel to the Agent, suspension or debarmentwill rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. Except as Neither the Company or the Subsidiary, nor their respective officers, directors, employees, agents and contractors (exercising their respective duties on behalf of the Company or the Subsidiary), nor the Company’s or the Subsidiary’s business operations, is, or at any time has been, in violation of any Health Care Laws, except where such violation would not reasonably be expected, individually or expected to result in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means shall mean (iA) the United States Federal federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section 301 §321 et seq.) ), and the regulations promulgated thereunder; , (iiB) all federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the Xxxxx Law (42 U.S.C. §1395nn), the Civil False Claims Act (31 X.X.X. §0000 et seq.), the Administrative False Claims Law (42 U.S.C. §1320a-7b(a)), the Anti-Inducement Law (42 U.S.C. §1320a-7a(a)(5)), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes, (C) the U.S. administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”§§1320d-1320d-8), as amended by the Health Information Technology for Economic regulations promulgated thereunder and Clinical Health comparable state laws, (D) the Controlled Substances Act (42 21 U.S.C. Section 17921 §801 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiE) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute Titles XVIII (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 §1395 et seq.), the exclusion laws ) and XIX (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, and the regulations promulgated pursuant to such statutes); (ivX.X.X. §0000 et seq.) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; , (viF) the Clinical Laboratory Improvement Amendments quality, safety and the regulations promulgated thereunder; accreditation standards and requirements of all applicable foreign or state laws or regulatory bodies, and (viiG) any and all other applicable health care laws and laws, regulations, in any jurisdiction where the Company or any manual provisions, policies and administrative guidance, each of its subsidiaries conducts business. Additionally, neither the Company, nor, (A) through (F) as may be amended from time to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarmenttime.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the Sxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national, supranational and foreign health care related fraud and abuse laws, including, without limitation, relating to the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), regulation of the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCompany or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any material compliance with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Public Health Information Technology for Economic and Clinical Health Service Act (42 U.S.C. Section 17921 201 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiii) all applicable federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws criminal false statements law (42 U.S.C. Section 1320a-7 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (iv) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (v) all other local, state, federal, national, supranational and foreign health care laws relating to the regulation of the Company or its subsidiaries, in each case excluding Privacy Laws; and (vi) the directives and regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating directors, or, to the Health Care Laws Company’s knowledge, any agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject reasonably be expected to result in debarment, suspension, or exclusion. Any certificate signed by any officer or representative of the Company, Company or any of its employeessubsidiaries and delivered to the Agent or counsel for the Agent in connection with an issuance of Shares shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby on the date of such certificate. The Company acknowledges that the Agent and, officers, directors or other third parties acting on behalf of or at the direction for purposes of the Companyopinions to be delivered pursuant to Section 4(p) hereof, counsel to exclusionthe Company and counsel to the Agent, suspension or debarmentwill rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. Except as The Company and its subsidiaries are, and at all times have been, in compliance with all Health Care Laws, except where failure to be so in compliance would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Laws (42 U.S.C. Section 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), all applicable federal, state, local and foreign criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 1320a-7), the statutes, regulations and 42 U.S.C. Section 1395nndirectives of applicable government funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the data privacy and security regulations promulgated thereunder; (iv) the U.S. Controlled Substances Act; Patient Protection and Affordable Care Act of 2010 (v) Titles XVIII Pub. Law 111-148), as amended by the Health Care and XIX Education Affordability Reconciliation Act of the U.S. Social Security Act and 2010 (Pub. Law 111-152), the regulations promulgated thereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies, including, but not limited to, all laws applicable to ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunderCompany; and (vii) any and all other applicable health care laws local, state, federal, national, supranational and regulationsforeign laws, in any jurisdiction where relating to the regulation of the Company or any of its subsidiaries. Neither the Company nor its subsidiaries conducts businesshave received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Except as would not reasonably be expected, individually or in the aggregate, to result in a Material Adverse Effect, the Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor its subsidiaries are a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, its subsidiaries nor any of its their respective employees, officers, officers or directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companyreasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expectedThe Company and its subsidiaries are, individually or and at all times have been, in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, compliance in all material respects with all Health Care Laws to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of extent applicable to the Company are not in violation or any of any applicable Health Care Lawsits subsidiaries or their respective businesses. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the Public Health Service Act, and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws criminal False Statements Law (42 U.S.C. Section 1320a-7 1320a-7b(a)), 18 U.S.C. Sections 286, 287, 1035, 1347, and 1349 the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1395nn1320d et seq.), and the regulations promulgated pursuant to such statutescivil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusions law (42 U.S.C. Section 1320a-7), laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the HITECH Act, (42 U.S.C. Section 17921 et seq.); (iv) the U.S. Controlled Substances ActPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) Titles XVIII licensure, quality, safety and XIX of the U.S. Social Security Act and the regulations promulgated thereunderaccreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws local, state, federal, national, supranational and regulationsforeign laws, in any jurisdiction where relating to the regulation of the Company or any of its subsidiaries conducts businesssubsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. Additionally, neither Neither the Company, norany of its subsidiaries, nor any of their respective officers, directors, employees and, to the knowledge of the CompanyCompany and each of its subsidiaries, any of their respective agents have engaged in activities which are, as applicable, cause for liability under a Health Care Law. Neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s or any of its subsidiaries’ knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. None of the Company nor any of its subsidiaries nor their respective employees, officers, directors directors, or, to the knowledge of the Company or other third parties acting any of its subsidiaries, their respective agents is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority related to activities conducted by or on behalf of the Company or at the direction any of its subsidiaries. Additionally, none of the Company in matters relating nor any of its subsidiaries nor their respective employees, officers, directors, or, to the Health Care Laws knowledge of the Company or any of its subsidiaries, their respective agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company or any of its subsidiaries, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable compliance with all Health Care LawsLaws in all material respects. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Public Health Information Technology for Economic and Clinical Health Service Act (42 U.S.C. Section 17921 201 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiii) all applicable federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws criminal false statements law (42 U.S.C. Section 1320a-7 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1395nn1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act; (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national, supranational and foreign laws, relating to the regulation of the Company or its subsidiaries, and (vii) the regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, expected to have a Material Adverse Effect, the CompanyCompany and each of its subsidiaries is conducting its business in compliance with all applicable health care laws, rules, and regulations of each jurisdiction in which it conducts its subsidiaries, and, to the knowledge of the Companybusiness (collectively, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means ”), including, without limitation, (iA) the United States Federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section §§ 301 et seq.), and the rules and regulations promulgated thereunder (as amended, collectively, the “FFDCA”), (B) all applicable federal and state fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated thereunder; pursuant to such statutes, (iiC) the U.S. Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. §§669, 1035, 1347 and 1518; 42 U.S.C. Section §1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 and the regulations promulgated thereunder, (D) the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (42 U.S.C. Section 17921 §1395w-101 et seq.)) and the regulations promulgated thereunder, (E) the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, (F) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiG) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute Medicaid (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, and the regulations promulgated pursuant to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and Title XIX of the U.S. Social Security Act Act) and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments , each of such applicable laws, rules and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where the Company or any of its subsidiaries conducts business. Additionally, neither the Company, nor, as may be amended from time to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarmenttime.

Compliance with Health Care Laws. Except as would not reasonably be expectednot, individually or in the aggregate, reasonably be expected to have result in a Material Adverse EffectChange, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s Company and its subsidiaries’ directorssubsidiaries are, officersand at all times since January 1, employees or other third parties acting on behalf of or at the direction of the Company are not 2017, have been, in violation of any applicable compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Health Insurance Portability Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and Accountability Act of 1996 287, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1320d et seq.), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and foreign health care related fraud (v) the directives and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, and the regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationscounterpart thereof. Since January 1, in any jurisdiction where 2017, neither the Company or nor any of its subsidiaries conducts business. Additionallyhas received written notice of any claim, neither the Companyaction, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the knowledge Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Since January 1, 2017, the Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, none of the Company, any of its subsidiaries or any of their respective employees, officers, directors directors, or other third parties acting on behalf of agents has, since January 1, 2017, been or at the direction of the Company in matters relating to the Health Care Laws has been is currently excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable material compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Health Insurance Portability and Accountability Act of 1996 Anti-Kickback Statute (42 U.S.C. Section 1320d 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the HIPAA, the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national, supranational and foreign health care related fraud and abuse laws, including, without limitation, relating to the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), regulation of the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCompany or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof to which the Company or its subsidiaries are subject. Neither the Company nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, norany of its subsidiaries, nor any of their respective employees, officers, directors, or to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expectednot, individually singly or in the aggregate, reasonably be expected to have result in a Material Adverse EffectEffect or except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, neither the Company, its subsidiaries, and, to the knowledge of the Company, nor the Company’s and its subsidiaries’ directorsbusiness operations, officers, employees or other third parties acting on behalf of or at the direction of the Company are not is in violation of any applicable Health Care Laws. For purposes of this Agreement, “"Health Care Laws” " means (iA) all federal and state fraud and abuse laws, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn and §1395(q)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 X.X.X. §0000 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalty laws (42 U.S.C. § 1320a-7a) and the regulations promulgated pursuant to such statutes, (B) the United States Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191) and the Health Information Technology for Economic and Clinical Health Act of 2009, and the regulations promulgated thereunder and comparable state privacy and security laws, (C) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder, (D) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder, (E) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section § 301 et seq.) and the regulations promulgated thereunder; pursuant thereto, (iiF) the U.S. Health Insurance Portability quality, safety and Accountability Act accreditation standards and requirements of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable all applicable state privacy and security laws ; (iii) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, and the regulations promulgated pursuant to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; or regulatory bodies and (viiG) any and all other applicable health care laws and laws, regulations, manual provisions, policies and administrative guidance, each of (A) through (G) as may be amended from time to time. Except as would not, singly or in any jurisdiction where the aggregate, reasonably be expected to result in a Material Adverse Effect or except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company or has not received notice of any of its subsidiaries conducts business. Additionallyclaim, neither the Companyaction, norsuit, to the knowledge of the Companyproceeding, any of its employeeshearing, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiryenforcement, investigation, proceeding, arbitration or other similar matter action from any Governmental Entity alleging that any product, operation or activity is in violation of any applicable Health Care Law or permit and has no knowledge that any such Governmental Entity is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and the Company has not received notice, either verbally or in writing, that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any permits and has no knowledge that any such Governmental Entity is considering such action, except for any of the foregoing that would subject the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, not reasonably be expected to exclusion, suspension or debarmentresult in a Material Adverse Effect.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, The Company and its subsidiaries, Subsidiary and, to the knowledge of the CompanySeller’s Knowledge, the Company’s and its subsidiaries’ their respective directors, officers, employees and agents (while acting in such capacity) are, and at all relevant times have been, in material compliance with all health care Laws and Guidelines applicable to the Company or its Subsidiary or by which any of their respective properties, Business, Products or other third parties acting on behalf of Assets is bound or at affected, including the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Civil Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), the exclusion laws administrative False Claims Law (42 U.S.C. Section 1320a-7 and § 1320a-7b(a)), the Exclusion Laws (42 U.S.C. Section 1395nn§ 1320a-7), and the FD&C Act, the Medicare Program (Title XVIII of the Social Security Act), the Medicaid Program (Title XIX of the Social Security Act), the regulations and Guidelines promulgated pursuant to such statutesLaws and any other similar Law (including any foreign Law); (iv) , including, to the U.S. Controlled Substances Act; (v) Titles XVIII extent applicable, the collection and XIX of the U.S. Social Security Act reporting requirements and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations promulgated thereunder; relating to the Medicaid Drug Rebate Program (vi42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Clinical Laboratory Improvement Amendments Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs (collectively, “Health Care Laws”). Neither Seller, the Company nor its Subsidiary has received any notification, correspondence or any other written or oral communication from any Governmental Authority, including the FDA, the Centers for Medicare and Medicaid Services and the regulations promulgated thereunder; Department of Health and (vii) any and all other applicable health care laws and regulationsHuman Services Office of Inspector General, in any jurisdiction where of potential or actual non-compliance by, or liability of, the Company or its Subsidiary, under any of its subsidiaries conducts business. Additionally, neither the Company, nor, to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarmentLaws.

Compliance with Health Care Laws. (a) Except as would not reasonably be expected, individually or disclosed in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction Section 3.23(a) of the Company are not Disclosure Letter, Company and its Subsidiaries are, and since January 1, 2008 have been, in violation material compliance with the Medicare statute (Title XVIII of any applicable Health Care Laws. For purposes the Social Security Act), the Medicaid statute (Title XIX of this Agreementthe Social Security Act), “Health Care Laws” means (i) the United States Federal federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section §§ 301 et seq.) the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), any applicable state fraud and abuse prohibitions, including those that apply to all payors (governmental, commercial insurance and self-payors), the regulations promulgated thereunder; Anti-Inducement Law (ii) 42 U.S.C. § 1320a-7a(a)(5)), the U.S. civil False Claims Act (31 U.S.C. §§ 3729 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 Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section §§ 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. Section 17921 et seq.)collectively, and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.“HIPAA”), the exclusion laws (42 U.S.C. Section 1320a-7 § 1320a-7), and 42 U.S.C. Section 1395nnany comparable state or local laws, and the regulations promulgated pursuant to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII laws, each as amended from time to time, and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsstate or federal law, in any jurisdiction where the Company or any of its subsidiaries conducts business. Additionallyregulation, neither the Companyguidance document, normanual provision, to the knowledge of the Companyprogram memorandum, any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceedingopinion letter, or other similar matter that would subject public issuance which regulates kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the Companyhiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of its employeesproviding health care services (each, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarmenta “Health Care Law”).

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Health Insurance Portability Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and Accountability Act of 1996 287, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1320d et seq.), the Sxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national, supranational and foreign health care related fraud and abuse laws, including, without limitation, relating to the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), regulation of the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCompany or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except Without limiting the generality of clause (xvii) above and except as described in the Registration Statement, the U.S. Prospectus and the Canadian Prospectus, neither the Company or its subsidiary, nor the Company’s or its subsidiary’s business operations is in violation of any Health Care Laws, except where the failure to be in compliance would not reasonably be expected, individually or expected to result in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal U.S. federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section 301 et seq.) Act, and the regulations promulgated thereunder; (ii) the all U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) Canadian federal, state, local state and foreign health care related provincial fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b§1320a7b(b)), the U.S. Civil Xxxxx Law (42 U.S.C. §1395nn), the U.S. civil False Claims Act (31 U.S.C. Section 3729 X.X.X. §0000 et seq.), the exclusion laws (42 U.S.C. Section Sections 1320a-7 and 1320a-7a of Title 42 U.S.C. Section 1395nn, of the United States Code and the regulations promulgated pursuant to such statutes); (iii) the U.S. Health Insurance Portability and Accountability Act of 1996 and the regulations promulgated thereunder; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments U.S. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the regulations promulgated thereunder; (vii) quality, safety and accreditation standards and requirements of all applicable state and provincial laws or regulatory bodies; and (viiviii) any and all other applicable health care laws and laws, regulations, in any jurisdiction where the Company or any manual provisions, policies and administrative guidance, each of its subsidiaries conducts business. Additionally, neither the Company, nor, (i) through (viii) as may be amended from time to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarmenttime.

Compliance with Health Care Laws. Except as In the past three years, the Company, XXXX XX and the Company’s subsidiaries have operated at all times and are currently in compliance with all Health Care Laws except where failure to be in compliance would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and foreign health care related fraud and abuse laws, includingsuch as, without limitationto the extent applicable, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws criminal False Statements Law (42 U.S.C. Section 1320a-7 1320a-7b(a)), 18 U.S.C. Sections 286, and 287, the health care fraud criminal provisions under HIPAA, the Civil Monetary Penalties Law (42 U.S.C. Section 1395nn1320a-7a), and the regulations promulgated pursuant to such statutesexclusion law (42 U.S.C. Section 1320a-7); (ivii) to the U.S. Controlled Substances extent applicable, HIPAA, as amended by the HITECH Act; (viii) Titles XVIII licensure, quality, safety and XIX of the U.S. Social Security Act accreditation requirements under applicable federal, state, local and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments foreign laws and the regulations promulgated thereunderregulatory bodies; and (viiiv) any and all other applicable health care laws local, state, federal, national, supranational and regulationsforeign laws, in relating to the regulation of the Company, XXXX XX and the Company’s subsidiaries and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any jurisdiction where product under development, manufactured or distributed by the Company Company, XXXX XX or any of its subsidiaries conducts businessthe Company’s subsidiaries. AdditionallyIn the past three years, neither the Company, XXXX XX nor the Company’s subsidiaries has received written notice of any action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product, operation or activity is in material violation of any Health Care Laws nor, to the knowledge Company’s or ATAI AG’s knowledge, is any such Action threatened, except where such action would not, individually or in the aggregate, have a Material Adverse Effect. In the past three years, except as would not, individually or in the aggregate, have a Material Adverse Effect, the Company, XXXX XX and the Company’s subsidiaries have filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims submissions and supplements or amendments as required by any applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company, XXXX XX nor the Company’s subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, in the past three years, none of the Company, XXXX XX, the Company’s subsidiaries or any of its their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws Company’s or ATAI AG’s knowledge, their agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company or XXXX XX, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as Neither the Company nor any of its subsidiaries is in violation of any Health Care Laws, except where the failure to be in compliance would not reasonably be expectednot, individually or in the aggregate, to reasonably be expected have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, ) and the regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances ActAct (21 U.S.C. Section 801 et seq.); and (v) Titles XVIII quality, safety and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other accreditation requirements under applicable health care federal, state, local or foreign laws and regulations, in any jurisdiction where the Company or any of its subsidiaries conducts businessregulatory bodies. Additionally, neither the CompanyCompany nor any of its subsidiaries, nor, to the knowledge of the Company, any of its their respective employees, officers, officers or directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company and its subsidiaries, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companyreasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Sxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, advertising, marketing or distribution of drugs and foreign medical devices (including diagnostic products), kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute FDA, the EMEA, Health Canada, the United States Federal Trade Commission, the United States Drug Enforcement Administration (42 U.S.C. Section 1320a-7b(b)“DEA”), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.)CMS, HHS’s Office of Inspector General, the exclusion laws (42 U.S.C. Section 1320a-7 United States Department of Justice and 42 U.S.C. Section 1395nnstate Attorneys General or similar agencies of potential or actual non-compliance by, and or liability of, the regulations promulgated pursuant Company under any Health Care Laws, except, with respect to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, in any jurisdiction where the Company or any of its subsidiaries conducts businessreasonably be expected to have a Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at ’s compliance therewith included in the direction of Prospectus fairly summarize the Company, to exclusion, suspension or debarmentmatters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or The Company and each of its Subsidiaries (i) is and at all times has been in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not compliance in violation of any all material respects with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) rules and regulations in the United States or any other jurisdiction, including, without limitation the Federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section §301 et seq.) ), all applicable federal, state, local and all foreign civil and criminal laws relating to health care fraud and abuse, including but not limited to the regulations promulgated thereunder; federal Anti-Kickback Statute (ii) 42 U.S.C. §1320a-7b(b)), the U.S. civil False Claims Act (31 U.S.C. §§ 3729 et seq.), criminal false statements (42 U.S.C. §1320a-7b(a)), the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section §§ 1320d et seq.) ), the exclusions law (“42 U.S.C. § 1320a-7), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil monetary penalties law (42 U.S.C. §1320a-7a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) (42 U.S.C. Section §§ 17921 et seq.), the Patient Protection and the regulations promulgated thereunder, and any comparable state privacy and security laws ; Affordable Care Act (iii) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. AntiPub. Law 111-Kickback Statute (42 U.S.C. Section 1320a-7b(b)148), as amended by the U.S. Civil False Claims Health Care and Education Affordability Reconciliation Act of 2010 (31 U.S.C. Section 3729 et seq.Pub. Law 111-152), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, and the regulations promulgated pursuant to such statuteslaws, and any successor government programs and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices, and all other local, state, federal, national, supranational and foreign laws applicable to the regulation of the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by or for the Company (collectively, the “Health Care Laws”); (ii) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter, or other correspondence or notice from the FDA or any other correspondence or notice from any other Regulatory Authority or Governmental Entity or third party alleging or asserting noncompliance with any Health Care Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any such applicable laws (“Authorizations”); (iii) possesses all material Authorizations and such Authorizations are valid and in full force and effect and are not in violation of any term of any such Authorizations; (iv) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the U.S. Controlled Substances ActFDA or any Governmental Entity or third party alleging that any product operation or activity is in violation of any Health Care Laws or Authorizations and has no knowledge that the FDA or any Governmental Entity or third party is considering any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action; (v) Titles XVIII has not received any notice that the FDA or any Governmental Entity or third party has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations and XIX of has no knowledge that the U.S. Social Security Act and the regulations promulgated thereunderFDA or any Governmental Entity or third party is considering any such limitation, suspension, modification or revocation; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunderdate filed (or were corrected or supplemented by a subsequent submission); and (vii) any and all other applicable health care laws and regulationshas not, in any jurisdiction where the Company or nor have any of its subsidiaries conducts business. Additionally, neither the Company, nor, to the knowledge of the Company, any of its employeesshareholders with more than five (5) percent interest, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has employees been excluded, suspended or debarred from participation in any U.S. state or federal health care program or is human clinical research or subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter any other action that would subject the Companyreasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable material compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Health Insurance Portability Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and Accountability Act of 1996 287, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national, supranational and foreign health care related fraud and abuse laws, including, without limitation, relating to the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), regulation of the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCompany or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, except where the failure to make any such submission would not be reasonably expected to have a Material Adverse Effect, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, any of its subsidiaries nor, to the knowledge of the Company’s knowledge, any of its their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject could reasonably be expected to result in debarment, suspension, or exclusion. Any certificate signed by any officer or representative of the Company, Company or any of its employeessubsidiaries and delivered to the Agent or counsel for the Agent in connection with an issuance of Shares shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby on the date of such certificate. The Company acknowledges that the Agent and, officers, directors or other third parties acting on behalf of or at the direction for purposes of the Companyopinions to be delivered pursuant to Section 4(o) hereof, counsel to exclusionthe Company and counsel to the Agent, suspension or debarmentwill rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in To the aggregate, to have a Material Adverse Effectbest of its knowledge, the Company, Company has operated and currently operates its subsidiaries, and, business in substantial compliance with all health care laws and regulations applicable to the knowledge Company or any of the Companyits clinical laboratory tests or activities, which may include, but are not limited to, the Company’s and its subsidiaries’ directorsClinical Laboratory Improvement Amendments of 1988, officersthe federal health care program Anti-Kickback Statute (42 USC Section 1320a-7b(b)), employees or other third parties acting on behalf of or at the direction of Anti-Inducement Law (42 USC Section 1320a-7a(a)(5)), the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 U.S.C. 31 USC Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 USC Section 1320a-7b(a)), the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. USC Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. USC Section 17921 et seq.), the federal health care program exclusion laws (42 USC Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 USC Section 301 et seq.), the Patient Protection and Affordable Care Act of 2010, Medicare (Title XVIII of the Social Security Act), any applicable equivalent foreign laws, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federalother applicable local, state, local and federal or foreign laws, rules, or regulations, which impose requirements on the manufacturing, development, testing, labeling, advertising, marketing or distribution of clinical laboratory or diagnostic products or services, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud programs, quality, safety, health information privacy, and abuse lawshealth information security (collectively, “Health Care Laws”), except where the failure to so operate or be in compliance would not have a Material Adverse Effect. The Company has not received any notification, correspondence or any other (i) written communication or (ii) formal oral communication on behalf of a Governmental Entity directed at an officer of the Company, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute Food and Drug Administration (42 U.S.C. Section 1320a-7b(b)the “FDA”), the U.S. Civil False Claims Act United States Drug Enforcement Administration, the United States Centers for Medicare and Medicaid Services (31 U.S.C. Section 3729 et seq.“CMS”), the exclusion laws United States Department of Health and Human Services’ (42 U.S.C. Section 1320a-7 “HHS”) Office of Inspector General, the United States Department of Justice and 42 U.S.C. Section 1395nnstate Attorneys General or similar agencies, or any health care facility Institutional Review Board, of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the foregoing, such as would not, in the aggregate, reasonably be expected to have a Material Adverse Effect. Except as set forth in the Registration Statement, the General Disclosure Package and the regulations promulgated pursuant to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where the Company or any of its subsidiaries conducts business. Additionally, neither the Company, norProspectus, to the knowledge of the Company’s knowledge, any of its employees, officers, directors there are no facts or other third parties acting on behalf of or at the direction circumstances that would reasonably be expected to give rise to material liability of the Company in matters relating to the under any Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarmentLaws.

Compliance with Health Care Laws. Except as Neither the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected, individually or expected to result in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Foodfederal and state fraud and abuse laws referred to generally or specifically in the Prospectus, Drugincluding, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the Xxxxx Law (42 U.S.C. § 1395nn and Cosmetic § 1395(q)), the civil False Claims Act (21 31 U.S.C. Section 301 § 3729 et seq.) ), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated thereunderpursuant to such statutes; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.Pub. L. No. 104-191) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, Medicare (Title XVIII of the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, Social Security Act) and the regulations promulgated pursuant to such statutes)thereunder; (iv) Medicaid (Title XIX of the U.S. Controlled Substances Social Security Act) and the regulations promulgated thereunder; (v) Titles XVIII the Medicare Prescription Drug, Improvement, and XIX Modernization Act of the U.S. Social Security Act 2003 (Pub. L. No. 108-173) and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments quality, safety and the regulations promulgated thereunderaccreditation requirements of all applicable state laws or regulatory bodies; and (vii) any and all other applicable federal, state, or foreign health care laws and or regulations, in any jurisdiction where each of (i) through (vii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or any of its subsidiaries conducts business. Additionally, neither warranties regarding compliance by the Company, nor, to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication ’s physician customers with an inquiry, investigation, proceeding, or other similar matter that would subject the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarmentapplicable laws.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have been in compliance in all material respects with all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Xxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the EMA, Health Canada, the U.S. Civil False Claims Act Federal Trade Commission, the U.S. Drug Enforcement Administration (31 U.S.C. Section 3729 et seq.“DEA”), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCMS, and the regulations promulgated pursuant to such statutes); (iv) HHS’s Office of Inspector General, the U.S. Controlled Substances Act; (v) Titles XVIII Department of Justice and XIX state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, result in any jurisdiction where the Company or any of its subsidiaries conducts businessa Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at ’s compliance therewith included in the direction of Registration Statement and in the Company, to exclusion, suspension or debarmentProspectus fairly summarize in all material respects the matters therein described.

Compliance with Health Care Laws. Except as The Company and its subsidiaries, if any, are and have been in compliance with all applicable Health Care Laws, except where the failure to do so would not reasonably be expectedexpected to have, individually singly or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the Public Health Service Act and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the U.S. civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false claims Law (42 U.S.C. § 1320a-7b(a)), 18 U.S.C. Sections 286, 287, 1347 and 1349, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 § 1320a-7) and the civil monetary penalties law (42 U.S.C. § 1320a-7a); (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 1395nn17921 et seq.), and the regulations promulgated pursuant to such statutes); (iv) Medicare (Title XVIII of the U.S. Controlled Substances Social Security Act); (v) Titles XVIII and Medicaid (Title XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunderAct); and (viivi) any and all other applicable similar or comparable health care laws and regulations, in any jurisdiction where . Neither the Company or nor any of its subsidiaries conducts business. Additionallysubsidiaries, neither the Companyif any, norhave received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator, Governmental Entity or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the knowledge of the Company’s knowledge, any of its employeesno such claim, officersaction, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excludedsuit, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiryproceeding, hearing, enforcement, investigation, proceeding, arbitration or other similar matter that would subject the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarmentaction is threatened.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have been in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Xxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the EMA, the TGA, Health Canada, the U.S. Civil False Claims Act Federal Trade Commission, the U.S. Drug Enforcement Administration (31 U.S.C. Section 3729 et seq.“DEA”), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCMS, and the regulations promulgated pursuant to such statutes); (iv) HHS’s Office of Inspector General, the U.S. Controlled Substances Act; (v) Titles XVIII Department of Justice and XIX state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, result in any jurisdiction where the Company or any of its subsidiaries conducts businessa Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company’s compliance therewith included in the Preliminary Prospectus, or any in the Time of its employees, officers, directors or other third parties acting on behalf of or at Sale Disclosure Package and in the direction of Prospectus fairly summarize the Company, to exclusion, suspension or debarmentmatters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have been in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Xxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.)EMA, Health Canada, the exclusion laws (42 U.S.C. Section 1320a-7 United States Federal Trade Commission, the United States Drug Enforcement Administration, CMS, HHS’s Office of Inspector General, the United States Department of Justice and 42 U.S.C. Section 1395nnstate Attorneys General or similar agencies of potential or actual non-compliance by, and or liability of, the regulations promulgated pursuant Company under any Health Care Laws, except, with respect to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, result in any jurisdiction where the Company or any of its subsidiaries conducts businessa Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company’s compliance therewith included in the Preliminary Prospectuses, or any in the Time of its employees, officers, directors or other third parties acting on behalf of or at Sale Disclosure Package and in the direction of Prospectuses fairly summarize the Company, to exclusion, suspension or debarmentmatters therein described.

Compliance with Health Care Laws. Except as The Company and its subsidiaries are, and during the last three years have been, in compliance, and have taken any required and necessary actions to comply, with all Health Care Laws, except where noncompliance would not reasonably be expected, individually singly or in the aggregate, aggregate reasonably be expected to have result in a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) all health care laws applicable to the United States Company or any of its subsidiaries, including, but not limited to: the Federal Food, Drug, and Cosmetic Act, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. Sec. 1320a-7a), the U.S. Physician Payment Sunshine Act (21 42 U.S.C. Sec. 1320a-7h), the U.S. Civil False Claims Act (31 U.S.C. Section 301 3729 et seq.) ), the criminal False Claims Act (42 U.S.C. Sec. 1320a-7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the regulations promulgated thereunder; (ii) health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.) ), the exclusion laws (“42 U.S.C. Sec. 1320a-7), HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and any and all other similar state, local, federal or foreign (including Israeli) health care laws and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) federal, state, local and foreign health care related fraud and abuse pursuant to such laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, and the FDA’s current good manufacturing practice regulations promulgated pursuant to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any at 21 CFR Part 820 and all other applicable health care laws and regulationsregulations applicable to ownership, in testing, development, manufacture, packaging, processing, use, distribution, storage, import, export or disposal of the Company’s or any jurisdiction where of its subsidiaries’ products, each as amended from time to time. Neither the Company nor any of its subsidiaries has received any Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the FDA, or written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority alleging a material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor any of its subsidiaries is a party to or has ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, none the Company or any of its subsidiaries conducts business. Additionallysubsidiaries, neither the Company, noror, to the knowledge of the Company, any of its or its subsidiaries’ employees, officers, officers or directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any U.S. federal health care program or human research study or clinical trial or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter action by any governmental authority that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have been in compliance in all material respects with all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Xxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the EMA, Health Canada, the U.S. Civil False Claims Act Federal Trade Commission, the U.S. Drug Enforcement Administration (31 U.S.C. Section 3729 et seq.“DEA”), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCMS, and the regulations promulgated pursuant to such statutes); (iv) HHS’s Office of Inspector General, the U.S. Controlled Substances Act; (v) Titles XVIII Department of Justice and XIX state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, result in any jurisdiction where the Company or any of its subsidiaries conducts businessa Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company’s compliance therewith included in the Preliminary Prospectus, or any in the Time of its employees, officers, directors or other third parties acting on behalf of or at Sale Disclosure Package and in the direction of Prospectus fairly summarize in all material respects the Company, to exclusion, suspension or debarmentmatters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have been in material compliance with, all health care laws applicable to the Company or any of the Companyits products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Xxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the EMA, Health Canada, the U.S. Civil False Claims Act Federal Trade Commission, the U.S. Drug Enforcement Administration (31 U.S.C. Section 3729 et seq.“DEA”), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCMS, and the regulations promulgated pursuant to such statutes); (iv) HHS’s Office of Inspector General, the U.S. Controlled Substances Act; (v) Titles XVIII Department of Justice and XIX state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, in any jurisdiction where the Company or any of its subsidiaries conducts businessreasonably be expected to have a Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at ’s compliance therewith included in the direction of Registration Statement and in the Company, to exclusion, suspension or debarmentProspectus fairly summarize the matters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Sxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, advertising, marketing or distribution of drugs and foreign medical devices (including diagnostic products), kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or, to the Company’s knowledge, oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute FDA, the EMEA, Health Canada, the United States Federal Trade Commission, the United States Drug Enforcement Administration (42 U.S.C. Section 1320a-7b(b)“DEA”), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.)CMS, HHS’s Office of Inspector General, the exclusion laws (42 U.S.C. Section 1320a-7 United States Department of Justice and 42 U.S.C. Section 1395nnstate Attorneys General or similar agencies of potential or actual non-compliance by, and or liability of, the regulations promulgated pursuant Company under any Health Care Laws, except, with respect to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, in any jurisdiction where the Company or any of its subsidiaries conducts businesshave a Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company’s compliance therewith included in the Registration Statement, or any the Time of its employees, officers, directors or other third parties acting on behalf of or at Sale Disclosure Package and the direction of Prospectus fairly summarize the Company, to exclusion, suspension or debarmentmatters therein described.

Compliance with Health Care Laws. Except None of the Company, its subsidiaries, nor, to Company’s knowledge, any director, officer, employee or agent of the Company is in violation of any Health Care Laws (as defined below), except where the failure to be in compliance would not reasonably be expectednot, individually or in the aggregate, to reasonably be expected have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement and any Terms Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and foreign health health-care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and of Title 42 U.S.C. Section 1395nn, of the United States Code and the regulations promulgated pursuant to such statutesstatutes; (iii) any criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); (iv) the Administrative Simplification provisions of HIPAA (42 U.S.C. Section 1320d et seq.), the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder including the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, and any state or non-U.S. counterpart thereof, and any other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (v) the U.S. Controlled Substances Act; Act (v21 U.S.C. Section 801 et seq.); (vi) Titles XVIII and XIX of the U.S. Social Security Prescription Drug Marketing Act of 1987, as amended, and the rules and regulations promulgated thereunder; (viviii) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunderAct; and (viiix) quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (x) any and all other applicable health care laws and regulationsregulations related to clinical research, testing, and medical product development activities, in any jurisdiction where that the Company or any of its subsidiaries conducts businessis subject to. Additionally, neither the Company, nor, to the knowledge none of the Company, its subsidiaries, any of its employeesdirector, officersofficer, directors employee or other third parties acting on behalf of or at the direction agent of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program program. To the Company’s knowledge, no director, officer, employee or agent of the Company has been disqualified by FDA as a clinical investigator. Neither the Company, its subsidiaries, nor, to the Company’s knowledge, any director, officer, employee or agent of the Company is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companyreasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Public Health Information Technology for Economic and Clinical Health Service Act (42 U.S.C. Section 17921 201 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiii) all applicable federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws criminal false statements law (42 U.S.C. Section 1320a-7 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the regulations promulgated pursuant to such statutesHealth Information Technology for Economic and Clinical Health Act, HITECH (42 U.S.C. Section 17921 et seq.); (iv) the U.S. Controlled Substances ActPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) Titles XVIII licensure, quality, safety and XIX of the U.S. Social Security Act accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and the regulations promulgated thereunder; (vi) all other local, state, federal, national, supranational and foreign laws, relating to the Clinical Laboratory Improvement Amendments and regulation of the regulations promulgated thereunder; Company or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes and any and all other applicable health care laws and regulations, in any jurisdiction where state or non-U.S. counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any federal and/or state court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries, nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expectedThe Company and the Subsidiaries are, individually or and at all times have been, in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Health Insurance Portability Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and Accountability Act of 1996 287, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national, supranational and foreign health care related fraud and abuse laws, including, without limitation, relating to the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), regulation of the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), Company or the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnSubsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes); (iv) statutes and any state or non-U.S. counterpart thereof. Neither the U.S. Controlled Substances Act; (v) Titles XVIII and XIX Company nor any of the U.S. Social Security Act Subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments Subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and the regulations promulgated thereunder; and (vii) supplements or amendments as required by any Health Care Laws, and all other applicable health care laws such reports, documents, forms, notices, applications, records, claims, submissions and regulations, supplements or amendments were complete and accurate on the date filed in any jurisdiction where all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company or nor any of its subsidiaries conducts businessthe Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge any of the Company, Subsidiaries nor any of its their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject could reasonably be expected to result in debarment, suspension, or exclusion. Any certificate signed by any officer or representative of the Company, Company or any of its employeesthe Subsidiaries and delivered to the Agent or counsel for the Agent in connection with an issuance of Shares shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby on the date of such certificate. The Company acknowledges that the Agent and, officers, directors or other third parties acting on behalf of or at the direction for purposes of the Companyopinions to be delivered pursuant to Section 4(o) hereof, counsel to exclusionthe Company and counsel to the Agent, suspension or debarmentwill rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have been in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Xxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the EMA, Health Canada, the U.S. Civil False Claims Act Federal Trade Commission, the U.S. Drug Enforcement Administration (31 U.S.C. Section 3729 et seq.“DEA”), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCMS, and the regulations promulgated pursuant to such statutes); (iv) HHS’s Office of Inspector General, the U.S. Controlled Substances Act; (v) Titles XVIII Department of Justice and XIX state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, in any jurisdiction where the Company or any of its subsidiaries conducts businessreasonably be expected to have a Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at ’s compliance therewith included in the direction of Registration Statement and in the Company, to exclusion, suspension or debarmentProspectus fairly summarize the matters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Xxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, regulation, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, advertising, marketing or distribution of medical devices, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, exclusion of individuals or companies from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure or any other aspect of providing health care or medical products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.)United States Federal Trade Commission, the exclusion laws (42 U.S.C. Section 1320a-7 United States Department of Health and 42 U.S.C. Section 1395nnHuman Services Office of Inspector General, the United States Department of Justice and state Attorneys General or similar agencies of non-compliance by, or liability of, the regulations promulgated pursuant Company under any Health Care Laws, except, with respect to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, in any jurisdiction where the Company or any of its subsidiaries conducts businesshave a Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company’s material compliance therewith included in the Registration Statement, or any in the Time of its employees, officers, directors or other third parties acting on behalf of or at Sale Disclosure Package and in the direction of Prospectus fairly summarize the Company, to exclusion, suspension or debarmentmatters therein described.

Compliance with Health Care Laws. Except Each Bioventus Party and its subsidiaries are and have been in material compliance with the Health Care Laws (as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, defined below) since three years prior to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Lawsdate hereof. For purposes of this Agreement, the “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the all applicable U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), 18 U.S.C. Sections 286 and 287, the federal health care program false statement law (42 U.S.C. § 1320a-7b(a)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§ 1320d et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 § 1320a-7), applicable Medicare (Title XVIII of the Social Security Act) and 42 U.S.C. Section 1395nnMedicaid (Title XIX of the Social Security Act) laws, and the statutes of applicable government funded or sponsored health care programs, and the regulations promulgated pursuant to such statutes; (iii) the Administrative Simplification provisions of HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.), and the regulations promulgated thereunder and any applicable state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the data and/or privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX applicable provisions of the U.S. Social Security Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, and the regulations promulgated thereunder; (viv) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunderPhysician Payment Sunshine Act (42 U.S.C. § 1320a-7h); and (vii) quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies, each as applicable to each Bioventus Party and its subsidiaries. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, or that, individually or in the aggregate, if determined adversely to any and all other applicable health care laws and regulations, in any jurisdiction where the Company Bioventus Party or any of its subsidiaries, would not reasonably be expected to have a Material Adverse Effect, none of the Bioventus Parties or any of their respective subsidiaries conducts business. Additionallyhas, neither since three years prior to the Companydate hereof, received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority (including any unresolved Form 483 from the U.S. Food and Drug Administration) alleging that any product, operation or activity is in violation of any Health Care Laws (other than any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action which has been resolved without the payment of any fine or penalty on the part of any Bioventus Party or its subsidiaries) nor, to the knowledge of the CompanyBioventus Parties, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, (x) the Bioventus Parties and their subsidiaries have filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and (y) all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission). None of the Bioventus Parties or any of their respective subsidiaries is a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by any governmental or regulatory authority, or has any reporting obligations, plan of correction or other remedial measures entered into pursuant to any such agreement entered into with, or such decree or order issued by, any such governmental or regulatory authority. Additionally, none of its the Bioventus Parties or any of their respective subsidiaries nor any of their respective employees, officers, officers or directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been is listed as excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Bioventus Parties, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as Neither the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected, individually or expected to result in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section § 301 et seq.) and the regulations promulgated thereunder); (ii) the foreign, federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes, all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the healthcare fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section § 1320d et seq.); (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. Section § 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, Medicare (Title XVIII of the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, Social Security Act) and the regulations promulgated pursuant to such statutes); (iv) the U.S. Controlled Substances Actthereunder; (v) Titles XVIII and Medicaid (Title XIX of the U.S. Social Security Act Act) and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations promulgated thereunderrelating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federal, state, or foreign health care laws and or regulations, in any jurisdiction where including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable laws. Neither the Company nor any subsidiary has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator, governmental or regulatory authority, or third-party alleging that any product, operation or activity is in violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened, except, in each case, as would not reasonably be expected to result in a Material Adverse Effect. To the Company’s knowledge, neither the Company nor any subsidiary has engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal health care program. Neither the Company nor any subsidiary is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of its subsidiaries conducts businesscorrection or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nornor any subsidiary, to the knowledge of the Company, nor any of its employees, their respective officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws employees has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Sxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, advertising, marketing or distribution of drugs and foreign medical devices (including diagnostic products), kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute FDA, the EMEA, Health Canada, the United States Federal Trade Commission, the United States Drug Enforcement Administration (42 U.S.C. Section 1320a-7b(b)“DEA”), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.)CMS, HHS’s Office of Inspector General, the exclusion laws (42 U.S.C. Section 1320a-7 United States Department of Justice and 42 U.S.C. Section 1395nnstate Attorneys General or similar agencies of potential or actual non-compliance by, and or liability of, the regulations promulgated pursuant Company under any Health Care Laws, except, with respect to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, in any jurisdiction where the Company or any of its subsidiaries conducts businesshave a Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at ’s compliance therewith included in the direction of Registration Statement and the Company, to exclusion, suspension or debarmentProspectus fairly summarize the matters therein described.

Compliance with Health Care Laws. Except Each Bioventus Party and its subsidiaries are and have been in material compliance with the Health Care Laws (as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, defined below) since three years prior to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Lawsdate hereof. For purposes of this Agreement, the “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the all applicable U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section § 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section §§ 3729 et seq.), 18 U.S.C. Sections 286 and 287, the federal health care program false statement law (42 U.S.C. § 1320a-7b(a)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§ 1320d et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 § 1320a-7), applicable Medicare (Title XVIII of the Social Security Act) and 42 U.S.C. Section 1395nnMedicaid (Title XIX of the Social Security Act) laws, and the statutes of applicable government funded or sponsored health care programs, and the regulations promulgated pursuant to such statutes; (iii) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.), and the regulations promulgated thereunder and any applicable state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the data and/or privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX applicable provisions of the U.S. Social Security Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, and the regulations promulgated thereunder; (viv) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunderPhysician Payment Sunshine Act (42 U.S.C. § 1320a-7h); and (vii) quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies, each as applicable to each Bioventus Party and its subsidiaries. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, or that, individually or in the aggregate, if determined adversely to any and all other applicable health care laws and regulations, in any jurisdiction where the Company Bioventus Party or any of its subsidiaries, would not reasonably be expected to have a Material Adverse Effect, none of the Bioventus Parties or any of their respective subsidiaries conducts business. Additionallyhas, neither since three years prior to the Companydate hereof, received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority (including any unresolved Form 483 from the U.S. Food and Drug Administration) alleging that any product, operation or activity is in violation of any Health Care Laws (other than any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action which has been resolved without the payment of any fine or penalty on the part of any Bioventus Party or its subsidiaries) nor, to the knowledge of the CompanyBioventus Parties, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, (x) the Bioventus Parties and their subsidiaries have filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and (y) all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission). None of the Bioventus Parties or any of their respective subsidiaries is a party to any material corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by any governmental or regulatory authority, or has any reporting obligations, plan of correction or other remedial measures entered into pursuant to any such agreement entered into with, or such decree or order issued by, any such governmental or regulatory authority. Additionally, none of its the Bioventus Parties or any of their respective subsidiaries nor any of their respective employees, officers, officers or directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been is listed as excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Bioventus Parties, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have been in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Xxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the EMA, Health Canada, the U.S. Civil False Claims Act Federal Trade Commission, the U.S. Drug Enforcement Administration (31 U.S.C. Section 3729 et seq.“DEA”), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCMS, and the regulations promulgated pursuant to such statutes); (iv) HHS’s Office of Inspector General, the U.S. Controlled Substances Act; (v) Titles XVIII Department of Justice and XIX state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, result in any jurisdiction where the Company or any of its subsidiaries conducts businessa Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at ’s compliance therewith included in the direction of Registration Statement and in the Company, to exclusion, suspension or debarmentProspectus fairly summarize the matters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any material compliance with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) all applicable federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. Section 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), all applicable federal, state, local and all foreign criminal laws relating to health care fraud and abuse, including but not limited to the U.S. False Statements Law (42 U.S.C. Section 1320a- 7b(a)), 18 U.S.C. Sections 286, 287, 1035, 1347, 1349 and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 1320a-7), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, including the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. Section 1395nn§ 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs, and the regulations promulgated pursuant to such statutes; (iii) to the extent applicable, the Standards for Privacy of Individually Identifiable Health Information (the “Privacy Rule”), the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII Patient Protection and XIX Affordable Care Act of 2010, as amended by the U.S. Social Security Health Care and Education Reconciliation Act and of 2010, the regulations promulgated thereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) the Clinical Laboratory Improvement Amendments licensure, quality, safety and the regulations promulgated thereunderaccreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable health care laws local, state, federal, national, supranational and regulationsforeign laws, in any jurisdiction where relating to the regulation of the Company or its subsidiaries. Neither the Company nor any of its subsidiaries conducts businesshas received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other material action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product, operation, or activity is in violation of any Health Care Laws nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were in all material respects timely, complete, accurate and not misleading on the date filed (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating or, to the Health Care Laws Company’s knowledge, agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any material compliance with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. Section 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), all applicable federal, state, local and all foreign criminal laws relating to health care fraud and abuse, including but not limited to the U.S. False Statements Law (42 U.S.C. Section 1320a- 7b(a)), 18 U.S.C. Sections 286, 287, 1035, 1347, 1349 and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the statutes, regulations and directives of applicable government funded or sponsored healthcare programs, including the collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (“42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs, and the regulations promulgated pursuant to such statutes; (iii) to the extent applicable, the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, thereunder and any comparable state or non-U.S. counterpart thereof or other law or regulation the purpose of which is to protect the privacy and security laws ; (iii) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, and the regulations promulgated pursuant to such statutes)of individuals or prescribers; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII Patient Protection and XIX Affordable Care Act of 2010, as amended by the U.S. Social Security Health Care and Education Reconciliation Act and of 2010, the regulations promulgated thereunder; (v) the U.S. Controlled Substances Act (21 U.S.C. Section 801 et seq.); (vi) the Clinical Laboratory Improvement Amendments licensure, quality, safety and the regulations promulgated thereunderaccreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other applicable health care laws local, state, federal, national, supranational and regulationsforeign laws, in any jurisdiction where relating to the regulation of the Company or its subsidiaries. Neither the Company nor any of its subsidiaries conducts businesshas received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other correspondence or written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other material action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product, operation, or activity is in violation of any Health Care Laws nor is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were in all material respects timely, complete, accurate and not misleading on the date filed (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, deferred or non- prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating or, to the Health Care Laws Company’s knowledge, agents, has been excluded, suspended or debarred from participation in any U.S. federal health care program (as defined in 42 USC § 1320a-7b(f)) or human clinical research or is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Health Insurance Portability Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and Accountability Act of 1996 287, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national, supranational and foreign health care related fraud and abuse laws, including, without limitation, relating to the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), regulation of the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCompany or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expectednot, individually singly or in the aggregate, reasonably be expected to have result in a Material Adverse EffectEffect or except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, neither the Company, its subsidiaries, and, to the knowledge of the Company, nor the Company’s and its subsidiaries’ directorsbusiness operations, officers, employees or other third parties acting on behalf of or at the direction of the Company are not is in violation of any applicable Health Care Laws. For purposes of this Agreement, “"Health Care Laws” " means (iA) all federal and state fraud and abuse laws, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7(b)), the Xxxxx Law (42 U.S.C. §1395nn and §1395(q)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 X.X.X. §0000 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the exclusion laws (42 U.S.C. § 1320a-7), the civil monetary penalty laws (42 U.S.C. § 1320a-7a) and the regulations promulgated pursuant to such statutes, (B) the United States Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191) and the Health Information Technology for Economic and Clinical Health Act of 2009, and the regulations promulgated thereunder and comparable state privacy and security laws, (C) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder, (D) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder, (E) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section § 301 et seq.) and the regulations promulgated thereunder; pursuant thereto, (iiF) the U.S. Health Insurance Portability quality, safety and Accountability Act accreditation standards and requirements of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable all applicable state privacy and security laws ; (iii) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, and the regulations promulgated pursuant to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; or regulatory bodies and (viiG) any and all other applicable health care laws and laws, regulations, manual 763344-4-33-v0.24 - 10 - 80-40671377 provisions, policies and administrative guidance, each of (A) through (G) as may be amended from time to time. Except as would not, singly or in any jurisdiction where the aggregate, reasonably be expected to result in a Material Adverse Effect or except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company or has not received notice of any of its subsidiaries conducts business. Additionallyclaim, neither the Companyaction, norsuit, to the knowledge of the Companyproceeding, any of its employeeshearing, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiryenforcement, investigation, proceeding, arbitration or other similar matter action from any Governmental Entity alleging that any product, operation or activity is in violation of any applicable Health Care Law or permit and has no knowledge that any such Governmental Entity is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; and the Company has not received notice, either verbally or in writing, that any Governmental Entity has taken, is taking or intends to take action to limit, suspend, modify or revoke any permits and has no knowledge that any such Governmental Entity is considering such action, except for any of the foregoing that would subject the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, not reasonably be expected to exclusion, suspension or debarmentresult in a Material Adverse Effect.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have been in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Sxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes legally binding requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the EMA, Health Canada, the U.S. Civil False Claims Act Federal Trade Commission, the U.S. Drug Enforcement Administration (31 U.S.C. Section 3729 et seq.“DEA”), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCMS, and the regulations promulgated pursuant to such statutes); (iv) HHS’s Office of Inspector General, the U.S. Controlled Substances Act; (v) Titles XVIII Department of Justice and XIX state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, result in any jurisdiction where the Company or any of its subsidiaries conducts businessa Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at ’s compliance therewith included in the direction of Registration Statement and in the Company, to exclusion, suspension or debarmentProspectus fairly summarize the matters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any compliance with all applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) ), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder; (ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the U.S. Health Insurance Portability Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and Accountability Act of 1996 287, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vi) all other local, state, federal, national, supranational and foreign health care related fraud and abuse laws, including, without limitation, relating to the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), regulation of the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCompany or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes); (iv) the statutes and any state or non-U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulations, in any jurisdiction where counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject could reasonably be expected to result in debarment, suspension, or exclusion. Any certificate signed by any officer or representative of the Company, Company or any of its employeessubsidiaries and delivered to the Agent or counsel for the Agent in connection with an issuance of Shares shall be deemed a representation and warranty by the Company to the Agent as to the matters covered thereby on the date of such certificate. The Company acknowledges that the Agent and, officers, directors or other third parties acting on behalf of or at the direction for purposes of the Companyopinions to be delivered pursuant to Section 4(o) hereof, counsel to exclusionthe Company and counsel to the Agent, suspension or debarmentwill rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Sxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, advertising, marketing or distribution of drugs and foreign medical devices (including diagnostic products), kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any written notification, correspondence or other communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute FDA, the EMEA, Health Canada, the United States Federal Trade Commission, the United States Drug Enforcement Administration (42 U.S.C. Section 1320a-7b(b)“DEA”), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.)CMS, HHS’s Office of Inspector General, the exclusion laws (42 U.S.C. Section 1320a-7 United States Department of Justice and 42 U.S.C. Section 1395nnstate Attorneys General or similar agencies of potential or actual non-compliance by, and or liability of, the regulations promulgated pursuant Company under any Health Care Laws, except, with respect to such statutes); (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, result in any jurisdiction where the Company or any of its subsidiaries conducts businessa Material Adverse Change. Additionally, neither the Company, nor, The statements with respect to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at ’s compliance therewith included in the direction of Registration Statement and the Company, to exclusion, suspension or debarmentProspectus fairly summarize the matters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have been in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Sxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the EMA, Health Canada, the U.S. Civil False Claims Act Federal Trade Commission, the U.S. Drug Enforcement Administration (31 U.S.C. Section 3729 et seq.“DEA”), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCMS, and the regulations promulgated pursuant to such statutes); (iv) HHS’s Office of Inspector General, the U.S. Controlled Substances Act; (v) Titles XVIII Department of Justice and XIX state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, in any jurisdiction where the Company or any of its subsidiaries conducts businessreasonably be expected to have a Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at ’s compliance therewith included in the direction of Registration Statement and in the Company, to exclusion, suspension or debarmentProspectus fairly summarize in all material respects the matters therein described.

Compliance with Health Care Laws. Except Without limiting the generality of clause (xvii) above and except as described in the Registration Statement, the U.S. Prospectus and the Canadian Prospectus, neither the Company or any subsidiary, nor the Company's or any subsidiary's business operations is in violation of any Health Care Laws, except where the failure to be in compliance would not reasonably be expected, individually or expected to result in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “"Health Care Laws” means " means: (i) the United States Federal U.S. federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section 301 et seq.) Act, and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability all U.S and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iii) Canadian federal, state, local state and foreign health care related provincial fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil Stark Law (42 U.S.C. Section 1395nn), the U.S. civil False Claims Clxxxx Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section Sections 1320a-7 and 1320a-7a of Title 42 U.S.C. Section 1395nn, of the United States Code and the regulations promulgated pursuant to such statutes); (iii) the U.S. Health Insurance Portability and Accountability Act of 1996 and the regulations promulgated thereunder; (iv) the U.S. Controlled Substances Act; (v) Titles XVIII and XIX of the U.S. Social Security Act and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments U.S. Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the regulations promulgated thereunder; (vii) quality, safety and accreditation standards and requirements of all applicable state and provincial laws or regulatory bodies; and (viiviii) any and all other applicable health care laws and laws, regulations, in any jurisdiction where the Company or any manual provisions, policies and administrative guidance, each of its subsidiaries conducts business. Additionally, neither the Company, nor, (i) through (viii) as may be amended from time to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarmenttime.

Compliance with Health Care Laws. Except as Neither the Company or any subsidiary, nor the Company’s or any subsidiary’s business operations is in violation of any Health Care Laws, except where such violation would not reasonably be expected, individually or expected to result in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, Drug and Cosmetic Act (21 U.S.C. Section § 301 et seq.) and the regulations promulgated thereunder); (ii) the foreign, federal and state fraud and abuse laws referred to generally or specifically in the Preliminary Prospectus and the Prospectus, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes, all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the healthcare fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section § 1320d et seq.); (iii) (“HIPAA”)HIPAA , as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. Section § 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiiv) federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, Medicare (Title XVIII of the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nn, Social Security Act) and the regulations promulgated pursuant to such statutes); (iv) the U.S. Controlled Substances Actthereunder; (v) Titles XVIII and Medicaid (Title XIX of the U.S. Social Security Act Act) and the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments collection and reporting requirements, and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations promulgated thereunderrelating to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8) and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs; and (vii) quality, safety and accreditation requirements of all applicable state laws or regulatory bodies; (viii) any and all other applicable federal, state, or foreign health care laws and or regulations, in any jurisdiction where including for each of (i) through (viii) as may be amended from time to time. Notwithstanding the foregoing or anything herein to the contrary, the Company makes no representations or warranties regarding compliance by the Company’s physician customers with applicable laws. Neither the Company nor any subsidiary has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court, arbitrator, governmental or regulatory authority, or third-party alleging that any product, operation or activity is in violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened, except, in each case, as would not reasonably be expected to result in a Material Adverse Effect. To the Company’s knowledge, neither the Company nor any subsidiary has engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal health care program. Neither the Company nor any subsidiary is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of its subsidiaries conducts businesscorrection or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nornor any subsidiary, to the knowledge of the Company, nor any of its employees, their respective officers, directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws employees has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directorssubsidiaries are, officersand at all times have been, employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable compliance with all Health Care Laws. For purposes of this Agreement, “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Public Health Information Technology for Economic and Clinical Health Service Act (42 U.S.C. Section 17921 201 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws ; (iiiii) all applicable federal, state, local and foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the exclusion laws criminal false statements law (42 U.S.C. Section 1320a-7 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320d et seq.), the Xxxxx Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government funded or sponsored healthcare programs; (iii) HIPAA, as amended by the regulations promulgated pursuant to such statutesHealth Information Technology for Economic and Clinical Health Act, HITECH (42 U.S.C. Section 17921 et seq.); (iv) the U.S. Controlled Substances ActPatient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010; (v) Titles XVIII licensure, quality, safety and XIX of the U.S. Social Security Act accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and the regulations promulgated thereunder; (vi) all other local, state, federal, national, supranational and foreign laws, relating to the Clinical Laboratory Improvement Amendments and regulation of the regulations promulgated thereunder; Company or its subsidiaries, and (vii) the directives and regulations promulgated pursuant to such statutes and any and all other applicable health care laws and regulations, in any jurisdiction where state or non-U.S. counterpart thereof. Neither the Company or nor any of its subsidiaries conducts businesshas received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any federal and/or state court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. The Company and its subsidiaries have filed, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, any of its subsidiaries nor any of their respective employees, officers, directors directors, or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge of Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have been in material compliance with, all health care laws applicable to the Company, or any of its products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Sxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the EMA, Health Canada, the U.S. Civil False Claims Act Federal Trade Commission, the U.S. Drug Enforcement Administration (31 U.S.C. Section 3729 et seq.“DEA”), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCMS, and the regulations promulgated pursuant to such statutes); (iv) HHS’s Office of Inspector General, the U.S. Controlled Substances Act; (v) Titles XVIII Department of Justice and XIX state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, result in any jurisdiction where the Company or any of its subsidiaries conducts businessa Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company, or any of its employees, officers, directors or other third parties acting on behalf of or at ’s compliance therewith included in the direction of Registration Statement and in the Company, to exclusion, suspension or debarmentProspectus fairly summarize the matters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, The Company and, to the knowledge Company’s knowledge, its directors, employees and agents (while acting in such capacity) are and at all times have been in material compliance with, all health care laws applicable to the Company or any of the Companyits products or activities, including, but not limited to, the Company’s and its subsidiaries’ directorsfederal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), officersthe Anti-Inducement Law (42 U.S.C. Section 1320a-7a(a)(5)), employees or other third parties acting on behalf of or at the direction of the Company are not in violation of any applicable Health Care Laws. For purposes of this Agreement, “Health Care Laws” means (i) the United States Federal Food, Drug, and Cosmetic civil False Claims Act (21 31 U.S.C. Section 301 3729 et seq.) and ), the regulations promulgated thereunder; administrative False Claims Law (ii) 42 U.S.C. Section 1320a-7b(a)), the U.S. Xxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), the exclusion laws (42 U.S.C. Section 1320a-7), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.), the Controlled Substances Act (21 U.S.C. Section 801 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Section 263a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, the regulations promulgated thereunderpursuant to such laws, and any comparable state privacy and security laws ; (iii) federal, other state, local and federal or foreign law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on manufacturing, development, testing, labeling, advertising, marketing, promotion, distribution, reporting, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care related fraud and abuse lawsprograms, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care, clinical laboratory or diagnostics products or services (collectively, “Health Care Laws”). The Company has not received any notification, correspondence or any other written communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b))FDA, the EMA, Health Canada, the U.S. Civil False Claims Act Federal Trade Commission, the U.S. Drug Enforcement Administration (31 U.S.C. Section 3729 et seq.“DEA”), the exclusion laws (42 U.S.C. Section 1320a-7 and 42 U.S.C. Section 1395nnCMS, and the regulations promulgated pursuant to such statutes); (iv) HHS’s Office of Inspector General, the U.S. Controlled Substances Act; (v) Titles XVIII Department of Justice and XIX state Attorneys General or similar agencies of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws, except, with respect to any of the U.S. Social Security Act and foregoing, such as would not, individually or in the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments and the regulations promulgated thereunder; and (vii) any and all other applicable health care laws and regulationsaggregate, result in any jurisdiction where the Company or any of its subsidiaries conducts businessa Material Adverse Effect. Additionally, neither To the Company’s knowledge, nor, there are no facts or circumstances that would reasonably be expected to the knowledge of the Company, any of its employees, officers, directors or other third parties acting on behalf of or at the direction give rise to material liability of the Company in matters relating under any Health Care Laws. The statements with respect to the Health Care Laws has been excluded, suspended or debarred from participation in any federal health care program or is subject to or has been threatened in writing or via another official communication with an inquiry, investigation, proceeding, or other similar matter that would subject and the Company’s compliance therewith included in the Preliminary Prospectus, or any in the Time of its employees, officers, directors or other third parties acting on behalf of or at Sale Information and in the direction of Prospectus fairly summarize the Company, to exclusion, suspension or debarmentmatters therein described.

Compliance with Health Care Laws. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company, its subsidiaries, and, to the knowledge of the Company, the Company’s The Company and its subsidiaries’ directors, officers, employees or other third parties acting on behalf of or at subsidiaries are and have been in material compliance with the direction of the Company are not in violation of any applicable Health Care LawsLaws (as defined below) since January 1, 2010. For purposes of this Agreement, the “Health Care Laws” means means: (i) the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) and the regulations promulgated thereunder; (ii) the U.S. Health Insurance Portability and Accountability Act Clinical Laboratory Improvement Amendments of 1996 (42 U.S.C. Section 1320d et seq.) (“HIPAA”)1988, as amended applicable to the ownership, testing, development, use, marketing, labeling, promotion, offer for sale, or performance of any product manufactured or test offered by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder, and any comparable state privacy and security laws Company; (iii) all applicable U.S. federal, state, local and all applicable foreign health care related fraud and abuse laws, including, without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), all applicable federal, state, local and all foreign criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, and the exclusion laws health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. Section 1320a-7 1320d et seq.), the exclusion laws and 42 U.S.C. Section 1395nnthe statutes of applicable government funded or sponsored health care programs, and the regulations promulgated pursuant to such statutes); (iv) the Standards for Privacy of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any applicable state or non-U.S. Controlled Substances Actcounterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (v) Titles XVIII and XIX applicable provisions of the U.S. Social Security Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, the regulations promulgated thereunder; (vi) the Clinical Laboratory Improvement Amendments quality, safety and the regulations promulgated thereunderaccreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) any and all other local, state, federal, national, supranational and foreign laws, applicable health care laws to the Company and regulationsits subsidiaries. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor any of its subsidiaries has received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in violation of any jurisdiction where Health Care Laws (other than any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action which has been resolved without the payment of any fine or penalty on the part of the Company or any of its subsidiaries) nor, to the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Except as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect, the Company and its subsidiaries conducts businesshave filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed (or were corrected or supplemented by a subsequent submission). Neither the Company nor any of its subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company, nor, to the knowledge of the Company, its subsidiaries nor any of its their respective employees, officers, officers or directors or other third parties acting on behalf of or at the direction of the Company in matters relating to the Health Care Laws has been listed as excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to or has been threatened in writing or via another official communication with an a governmental inquiry, investigation, proceeding, or other similar matter action that would subject the Companycould result or reasonably be expected to result in debarment, suspension, or any of its employees, officers, directors or other third parties acting on behalf of or at the direction of the Company, to exclusion, suspension or debarment.