Common use of Compliance with Healthcare Laws Clause in Contracts

Compliance with Healthcare Laws. Each of the Company and its Subsidiaries and, to the knowledge of the Company, their directors, officers, employees and agents is, and at all times has been, in material compliance with all applicable healthcare laws and regulations, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.), the exclusion laws (42 U.S.C. § 1320a-7), and the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the regulations promulgated pursuant to such laws, and any other state or federal law, accreditation standards, regulation, guidance document, manual provision, program memorandum, opinion letter, or other issuance which regulates 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 programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care or pharmaceutical services (collectively, the “Health Care Laws”); (ii) neither the Company nor any of its Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries, have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other governmental or regulatory authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or similar policies, set forth in any Health Care Law; (iii) neither the Company nor any of its Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under any Health Care Law, including, without limitation, 21 U.S.C. Section 335a; (iv) no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened, against the Company, its Subsidiaries or, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries; (v) neither the Company nor any of its Subsidiaries has received any notification, correspondence or any other written or oral communication from any governmental or regulatory entity (including, without limitation, the FDA, DEA, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services Office of Inspector General) of potential or actual material non-compliance by, or liability of, the Company or any of its Subsidiaries under any Health Care Law; (vi) 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 entity; and (vii) the manufacture of Company’s and its Subsidiaries products by or on behalf of the Company and/or its Subsidiaries is being conducted in compliance in all material respects with all applicable Laws, including, without limitation, the FDA’s current good manufacturing practice regulations for products in the United States, and the respective counterparts thereof promulgated by governmental and regulatory authorities in countries outside the United States.

Compliance with Healthcare Laws. (i) Each of the Company Company, its Subsidiaries, their directors and its Subsidiaries officers and, to the knowledge of the Company, their directors, officers, employees and agents is, and at all times has been, in material compliance with all applicable healthcare laws and regulations, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.), the exclusion laws (42 U.S.C. § 1320a-7), and the Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the regulations promulgated pursuant to such laws, and any other state or federal law, accreditation standards, regulation, guidance document, manual provision, program memorandum, opinion letter, or other issuance which regulates 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 programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care or pharmaceutical services (collectively, the “Health Care Laws”); (ii) neither the Company nor Company, any of its Subsidiaries Subsidiaries, their directors and officers nor, to the knowledge of the Company, any director, officer, employee, agent, employee agent or affiliate of the Company or any of its Subsidiaries, have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other governmental or regulatory authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or similar policies, set forth in any Health Care Law; (iii) neither the Company nor Company, any of its Subsidiaries Subsidiaries, their directors and officers nor, to the knowledge of the Company, any director, officer, employee, agent, employee agent or affiliate of the Company or any of its Subsidiaries has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under any Health Care Law, including, without limitation, 21 U.S.C. Section 335a; (iv) no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened, against the Company, its Subsidiaries Subsidiaries, their directors and officers or, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries; (v) neither the Company nor any of its Subsidiaries has received any notification, correspondence or any other written or oral communication from any governmental or regulatory entity (including, without limitation, the FDA, DEA, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services Office of Inspector General) of potential or actual material non-compliance by, or liability of, the Company or any of its Subsidiaries under any Health Care Law; (vi) 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 entity; and (vii) the manufacture of Company’s and its Subsidiaries products by or on behalf of the Company and/or its Subsidiaries is being conducted in compliance in all material respects with all applicable Laws, including, without limitation, the FDA’s current good manufacturing practice regulations for products in the United States, and the respective counterparts thereof promulgated by governmental and regulatory authorities in countries outside the United States, except, in each of (i)–(vii) above, as would not reasonably be expected, in whole or in part, individually or in the aggregate, to result in a Material Adverse Effect.

Compliance with Healthcare Laws. Each of the The Company and each of its Subsidiaries subsidiaries and, to the knowledge of the Company’s knowledge, their its directors, officers, employees employees, and agents is(while acting in such capacity) are, and at all times has since January 1, 2011 have been, in material compliance with with, all applicable healthcare laws applicable to the Company and regulationseach of its subsidiaries or any of its products or activities, including, without limitationbut not limited to, the federal Anti-kickback Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), the federal Physician Payment Sunshine Act (42 U.S.C. Section 1320a-7h), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.), the exclusion laws (42 U.S.C. § 1320a-7), and the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)Act, the Controlled Substances Act, the Public Health Service Act, Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the regulations promulgated pursuant to such laws, and any other state or federal lawlaw which imposes legal requirements on the manufacturing, accreditation standardsdevelopment, regulationtesting, guidance documentlabeling, manual provisionmarketing or distribution of pharmaceutical products, program memorandum, opinion letter, or other issuance which regulates 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 programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care or pharmaceutical services (collectively, the “Health Care Healthcare Laws”); (ii) neither the Company nor any of its Subsidiaries nor, to the knowledge of the Companyand have not engaged in activities which are, any directoras applicable, officerprohibited or cause for false claims liability, employeecivil penalties, agentor mandatory or permissive exclusion from Medicare, employee or affiliate of the Company or any of its Subsidiaries, have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA Medicaid or any other governmental state or regulatory authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or similar policies, set forth in any Health Care Law; (iii) neither the federal health care program. The Company nor any of its Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under any Health Care Law, including, without limitation, 21 U.S.C. Section 335a; (iv) no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened, against the Company, its Subsidiaries or, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries; (v) neither the Company nor any of its Subsidiaries has not received any notification, correspondence or any other written or oral communication communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental or regulatory entity (authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Centers for Medicare and & Medicaid Services, and the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General) , of potential or actual material non-compliance by, or liability of, the Company or any of its Subsidiaries subsidiaries under any Health Care Law; (vi) neither Laws. To the Company’s knowledge, there are no facts or circumstances that would reasonably be expected to give rise to liability of the Company nor or any of its Subsidiaries is a party to subsidiaries under any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory entity; and (vii) the manufacture of Company’s and its Subsidiaries products by or on behalf of the Company and/or its Subsidiaries is being conducted in compliance in all material respects with all applicable Healthcare Laws, including, without limitation, the FDA’s current good manufacturing practice regulations for products in the United States, and the respective counterparts thereof promulgated by governmental and regulatory authorities in countries outside the United States.

Compliance with Healthcare Laws. Each of the The Company and each of its Subsidiaries subsidiaries and, to the knowledge of the Company’s knowledge, their its directors, officers, employees employees, and agents is(while acting in such capacity) are, and at all times has since January 1, 2017 have been, in material compliance with all applicable healthcare laws to the extent applicable to the Company and regulationseach of its subsidiaries or any of its products or activities, including, without limitationbut not limited to, the federal Anti-kickback Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), the federal Physician Payment Sunshine Act (42 U.S.C. Section 1320a-7h), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.)Act, the exclusion laws (42 U.S.C. § 1320a-7), and the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)Act, the Public Health Service Act, Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the regulations promulgated pursuant to such laws, and any other state or federal lawlaw which imposes legal requirements on the manufacturing, accreditation standardsdevelopment, regulationtesting, guidance documentlabeling, manual provisionmarketing, program memorandumimport, opinion letter, export or other issuance which regulates kickbacks, patient or program chargesdistribution of pharmaceutical products, 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 programs, quality, safety, privacy, health data privacy and security, licensure, accreditation or any other aspect of providing health care or pharmaceutical services (collectively, the “Health Care Healthcare Laws”); (ii) neither the Company nor any of its Subsidiaries nor, to the knowledge of the Companyand have not engaged in activities which are, any directoras applicable, officerprohibited or cause for false claims liability, employeecivil penalties, agentor mandatory or permissive exclusion from Medicare, employee or affiliate of the Company or any of its Subsidiaries, have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA Medicaid or any other governmental state or regulatory authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or similar policies, set forth in any Health Care Law; (iii) neither the federal health care program. The Company nor any of its Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under any Health Care Law, including, without limitation, 21 U.S.C. Section 335a; (iv) no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened, against the Company, its Subsidiaries or, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries; (v) neither the Company nor any of its Subsidiaries has not received any notification, correspondence or any other written or oral communication communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental or regulatory entity (authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Centers for Medicare and & Medicaid Services, and the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General) , of potential or actual material non-compliance by, or liability of, the Company or any of its Subsidiaries subsidiaries under any Health Care Law; (vi) neither Laws. To the Company’s knowledge, there are no facts or circumstances that would reasonably be expected to give rise to liability of the Company nor or any of its Subsidiaries is a party to subsidiaries under any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory entity; and (vii) the manufacture of Company’s and its Subsidiaries products by or on behalf of the Company and/or its Subsidiaries is being conducted in compliance in all material respects with all applicable Healthcare Laws, including, without limitation, the FDA’s current good manufacturing practice regulations for products in the United States, and the respective counterparts thereof promulgated by governmental and regulatory authorities in countries outside the United States.

Compliance with Healthcare Laws. Each of The Company and its subsidiaries have been in compliance in all material respects with all applicable healthcare laws, rules and regulations, to the extent they apply to the Company and its Subsidiaries andcurrent activities, to including, without limitation, (i) the knowledge of the Company, their directors, officers, employees and agents is, and at all times has been, in material compliance with FDCA (21 U.S.C. §§ 301 et seq.); (ii) all applicable foreign, federal, state and local healthcare laws related fraud and regulationsabuse laws, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), the civil monetary penalties law (42 U.S.C. § 1320a-7a), the exclusion laws (42 U.S.C. § 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 and 1349, the healthcare fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. § §§1320d et seq.), the Medicare statute (Title XVIII of the Social Security Act), and the Medicaid statute (Title XIX of the Social Security Act); (iii) the patient privacy, data security and beach notification provisions under HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (the “HITECH Act”) (42 U.S.C. §§ §17921 et seq.), the exclusion laws ; (42 U.S.C. § 1320a-7), iv) comparable state and the Food Drug local laws; and Cosmetic Act (21 U.S.C. §§ 301 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), v) the regulations promulgated pursuant to such lawslaws (collectively, and the “Healthcare Laws”). Neither the Company nor any of its subsidiaries, nor to the Company’s knowledge, their officers, directors, employees, agents, have 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 law, accreditation standards, regulation, guidance document, manual provision, program memorandum, opinion letter, healthcare program. Neither the Company nor any of its subsidiaries has received written notice or other issuance which regulates kickbackscorrespondence of any claim, patient action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or program chargesother action (“Action”) from any court, recordkeepingarbitrator or Governmental Entity or third party alleging that any product, claims processoperation or activity is in violation of any Healthcare Laws, documentation requirementsand, medical necessityto the Company’s knowledge, referralsno such Action is threatened. Neither the Company nor any of its subsidiaries is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreement, the hiring deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of employees correction or acquisition of services similar agreement with or supplies from those who have been excluded from government health care programsimposed by any Governmental Entity. Additionally, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care or pharmaceutical services (collectively, the “Health Care Laws”); (ii) neither the Company nor any of its Subsidiaries norsubsidiaries, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries, have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other governmental or regulatory authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or similar policies, set forth in any Health Care Law; (iii) neither the Company nor any of its Subsidiaries northeir employees, officers or directors, or to the knowledge of the Company’s knowledge, any directoragents, officer, employee, agent, employee is or affiliate of the Company or any of its Subsidiaries has been convicted of any crime excluded, suspended or engaged debarred from participation in any conduct that has resulted, U.S. state or would reasonably be expected to result, in debarment under any Health Care Law, including, without limitation, 21 U.S.C. Section 335a; (iv) no claims, actions, proceedings federal healthcare program or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending human clinical research or, to the knowledge of the Company, threatenedis subject to a governmental inquiry, against the Companyinvestigation, its Subsidiaries or, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries; (v) neither the Company nor any of its Subsidiaries has received any notification, correspondence or any other written or oral communication from any governmental or regulatory entity (including, without limitation, the FDA, DEA, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services Office of Inspector General) of potential or actual material non-compliance byproceeding, or liability ofother similar action that could reasonably be expected to result in debarment, the Company or any of its Subsidiaries under any Health Care Law; (vi) neither the Company nor any of its Subsidiaries is a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orderssuspension, or similar agreements with or imposed by any governmental or regulatory entity; and (vii) the manufacture of Company’s and its Subsidiaries products by or on behalf of the Company and/or its Subsidiaries is being conducted in compliance in all material respects with all applicable Laws, including, without limitation, the FDA’s current good manufacturing practice regulations for products in the United States, and the respective counterparts thereof promulgated by governmental and regulatory authorities in countries outside the United Statesexclusion.

Compliance with Healthcare Laws. Each of the The Company and each of its Subsidiaries subsidiaries and, to the knowledge of the Company’s knowledge, their its directors, officers, employees employees, and agents is(while acting in such capacity) are, and at all times has since January 1, 2015 have been, in material compliance with with, all applicable healthcare laws applicable to the Company and regulationseach of its subsidiaries or any of its products or activities, including, without limitationbut not limited to, the federal Anti-kickback Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), the federal Physician Payment Sunshine Act (42 U.S.C. Section 1320a-7h), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.), the exclusion laws (42 U.S.C. § 1320a-7), and the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)Act, the Controlled Substances Act, the Public Health Service Act, Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the regulations promulgated pursuant to such laws, and any other state or federal law, accreditation standards, regulation, guidance document, manual provision, program memorandum, opinion letter, or other issuance which regulates imposes requirements on the manufacturing, development, testing, labeling, marketing or distribution of pharmaceutical 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 programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care or pharmaceutical services (collectively, the “Health Care Healthcare Laws”); (ii) neither the Company nor any of its Subsidiaries nor, to the knowledge of the Companyand have not engaged in activities which are, any directoras applicable, officerprohibited or cause for false claims liability, employeecivil penalties, agentor mandatory or permissive exclusion from Medicare, employee or affiliate of the Company or any of its Subsidiaries, have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA Medicaid or any other governmental state or regulatory authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or similar policies, set forth in any Health Care Law; (iii) neither the federal health care program. The Company nor any of its Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under any Health Care Law, including, without limitation, 21 U.S.C. Section 335a; (iv) no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened, against the Company, its Subsidiaries or, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries; (v) neither the Company nor any of its Subsidiaries has not received any notification, correspondence or any other written or oral communication communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental or regulatory entity (authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Centers for Medicare and & Medicaid Services, and the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General) , of potential or actual material non-compliance by, or liability of, the Company or any of its Subsidiaries subsidiaries under any Health Care Law; (vi) neither Laws. To the Company’s knowledge, there are no facts or circumstances that would reasonably be expected to give rise to liability of the Company nor or any of its Subsidiaries is a party to subsidiaries under any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory entity; and (vii) the manufacture of Company’s and its Subsidiaries products by or on behalf of the Company and/or its Subsidiaries is being conducted in compliance in all material respects with all applicable Healthcare Laws, including, without limitation, the FDA’s current good manufacturing practice regulations for products in the United States, and the respective counterparts thereof promulgated by governmental and regulatory authorities in countries outside the United States.

Compliance with Healthcare Laws. Each of the The Company and its Subsidiaries and, to the knowledge of the Company’s knowledge, their its directors, officers, employees and agents is, (while acting in such capacity) are and at all times has been, have been in material compliance with with, all health care laws applicable healthcare laws and regulationsto the Company, or any of its products or activities, including, without limitationbut not limited to, the federal Anti-kickback Kickback Statute (42 U.S.C. § 1320a-7b(bSection 1320a 7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5Section 1320a 7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(aSection 1320a 7b(a)), the 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.), ) 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. § 1320a-7Section 1320a 7), and the Food Drug 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 pursuant to such laws, and any other state state, federal or federal foreign law, accreditation standards, regulation, guidance document, manual provision, program memorandum, opinion letter, or other issuance which regulates 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 programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care care, clinical laboratory or pharmaceutical diagnostics products or services (collectively, the “Health Care Laws”); (ii) neither the . The Company nor any of its Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries, have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other governmental or regulatory authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or similar policies, set forth in any Health Care Law; (iii) neither the Company nor any of its Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under any Health Care Law, including, without limitation, 21 U.S.C. Section 335a; (iv) no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened, against the Company, its Subsidiaries or, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries; (v) neither the Company nor any of its Subsidiaries has not received any notification, correspondence or any other written or oral communication communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental or regulatory entity (authority, including, without limitation, the FDA, DEAU.S. Food and Drug Administration, the European Medicines Agency, the Australian Department of Health Therapeutic Goods Administration, Health Canada, the U.S. Federal Trade Commission, the U.S. Drug Enforcement Administration, U.S. Centers for Medicare and & Medicaid Services, and the U.S. Department of Health and Human Services Services’ Office of Inspector General) , the U.S. Department of Justice and state Attorneys General or similar agencies of potential or actual material non-compliance by, or liability of, the Company or any of its Subsidiaries under any Health Care Law; (vi) neither the Company nor Laws, except, with respect to any of its Subsidiaries is the foregoing, such as would not, individually or in the aggregate, result in a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory entity; and (vii) Material Adverse Change. To the manufacture of Company’s and its Subsidiaries products by knowledge, there are no facts or on behalf circumstances that would reasonably be expected to give rise to material liability of the Company and/or its Subsidiaries is being conducted in under any Health Care Laws. The statements with respect to Health Care Laws and the Company’s compliance in all material respects with all applicable Laws, including, without limitation, the FDA’s current good manufacturing practice regulations for products therewith included in the United StatesCompany’s Annual Report on Form 10-K filed with the Commission on October 14, and 2022, fairly summarize the respective counterparts thereof promulgated by governmental and regulatory authorities in countries outside the United Statesmatters therein described.

Compliance with Healthcare Laws. Each of the The Company and its Subsidiaries and, to the knowledge of the Company’s knowledge, their its directors, officers, employees and agents is, (while acting in such capacity) are and at all times has been, have been in material compliance with with, all health care laws applicable healthcare laws and regulationsto the Company, or any of its products or activities, including, without limitationbut not limited to, the federal Anti-kickback Kickback Statute (42 U.S.C. § 1320a-7b(bSection 1320a 7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5Section 1320a 7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(aSection 1320a 7b(a)), the 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.), ) 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. § 1320a-7Section 1320a 7), and the Food Drug 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 pursuant to such laws, and any other state state, federal or federal foreign law, accreditation standards, regulation, guidance document, manual provision, program memorandum, opinion letter, or other issuance which regulates 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 programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care care, clinical laboratory or pharmaceutical diagnostics products or services (collectively, the “Health Care Laws”); (ii) neither the . The Company nor any of its Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries, have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other governmental or regulatory authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or similar policies, set forth in any Health Care Law; (iii) neither the Company nor any of its Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under any Health Care Law, including, without limitation, 21 U.S.C. Section 335a; (iv) no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened, against the Company, its Subsidiaries or, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries; (v) neither the Company nor any of its Subsidiaries has not received any notification, correspondence or any other written or oral communication communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental or regulatory entity (authority, including, without limitation, the FDA, DEA, the U.S. Centers for Medicare and & Medicaid Services, and the U.S. Department of Health and Human Services Services’ Office of Inspector General) , the U.S. Department of Justice and state Attorneys General or similar agencies of potential or actual material non-compliance by, or liability of, the Company or any of its Subsidiaries under any Health Care Law; (vi) neither the Company nor Laws, except, with respect to any of its Subsidiaries is the foregoing, such as would not, individually or in the aggregate, result in a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory entity; and (vii) Material Adverse Change. To the manufacture of Company’s and its Subsidiaries products by knowledge, there are no facts or on behalf circumstances that would reasonably be expected to give rise to material liability of the Company and/or its Subsidiaries is being conducted in under any Health Care Laws. The statements with respect to Health Care Laws and the Company’s compliance in all material respects with all applicable Laws, including, without limitation, the FDA’s current good manufacturing practice regulations for products therewith included in the United StatesCompany’s Annual Report on Form 10-K filed with the Commission on March 26, and 2024, fairly summarize the respective counterparts thereof promulgated by governmental and regulatory authorities in countries outside the United Statesmatters therein described.

Compliance with Healthcare Laws. Each of the The Company and its Subsidiaries and, to the knowledge of the Company’s knowledge, their its directors, officers, employees employees, and agents is(while acting in such capacity) are, and at all times has since January 1, 2010 have been, in material compliance with with, all applicable healthcare laws and regulationsapplicable to the Company or any of its products or activities, including, without limitationbut not limited to, the federal Anti-kickback Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), the federal Physician Payment Sunshine Act (42 U.S.C. Section 1320a-7h), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.), the exclusion laws (42 U.S.C. § 1320a-7), and the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)Act, the Controlled Substances Act, Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the regulations promulgated pursuant to such laws, and any other state or federal law, accreditation standards, regulation, guidance document, manual provision, program memorandum, opinion letter, or other issuance which regulates imposes requirements on the manufacturing, development, testing, labeling, marketing or distribution of pharmaceutical 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 programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care or pharmaceutical services (collectively, the “Health Care Healthcare Laws”); (ii) neither the Company nor any of its Subsidiaries nor, to the knowledge of the Companyand have not engaged in activities which are, any directoras applicable, officerprohibited or cause for civil penalties, employeeor mandatory or permissive exclusion from Medicare, agent, employee or affiliate of the Company or any of its Subsidiaries, have committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA Medicaid or any other governmental state or regulatory authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or similar policies, set forth in any Health Care Law; (iii) neither the federal health care program. The Company nor any of its Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under any Health Care Law, including, without limitation, 21 U.S.C. Section 335a; (iv) no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened, against the Company, its Subsidiaries or, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries; (v) neither the Company nor any of its Subsidiaries has not received any notification, correspondence or any other written or oral communication communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental or regulatory entity (authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Agency Administration (“DEA”), the Centers for Medicare and & Medicaid Services, and or the U.S. Department of Health and Human Services Office of Inspector General) , of potential or actual material non-compliance by, or liability of, the Company or any of its Subsidiaries under any Health Care Law; (vi) neither Laws. To 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 entity; and (vii) the manufacture of Company’s and its Subsidiaries products by knowledge, there are no facts or on behalf circumstances that would reasonably be expected to give rise to liability of the Company and/or its Subsidiaries is being conducted in compliance in all material respects with all applicable under any Healthcare Laws, including, without limitation, the FDA’s current good manufacturing practice regulations for products in the United States, and the respective counterparts thereof promulgated by governmental and regulatory authorities in countries outside the United States.

Compliance with Healthcare Laws. Each of the The Company and its Subsidiaries and, to the knowledge of the Company’s knowledge, their its directors, officers, employees employees, and agents is(while acting in such capacity) are, and at all times has since January 1, 2010 have been, in material compliance with with, all applicable healthcare laws and regulationsapplicable to the Company or any of its products or activities, including, without limitationbut not limited to, the federal Anti-kickback Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), the federal Physician Payment Sunshine Act (42 U.S.C. Section 1320a-7h), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.), the exclusion laws (42 U.S.C. § 1320a-7), and the Food Drug Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.)Act, the Controlled Substances Act, Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the regulations promulgated pursuant to such laws, and any other state or federal law, accreditation standards, regulation, guidance document, manual provision, program memorandum, opinion letter, or other issuance which regulates imposes requirements on the manufacturing, development, testing, labeling, marketing or distribution of pharmaceutical 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 programs, quality, safety, privacy, security, licensure, accreditation or any other aspect of providing health care or pharmaceutical services (collectively, the “Health Care Healthcare Laws”); (ii) neither , except with respect to potential non-compliance with the Company nor federal Physician Payment Sunshine Act and similar applicable healthcare compliance certification, marketing and payment transparency laws occurring after January 1, 2012 in the states of Massachusetts, California, Nevada and Vermont and the District of Columbia, for which any of its Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries, have committed any act, made any statement or failed to make any statement that would potential liability is not reasonably be expected to provide a basis exceed $100,000 in the aggregate, and have not engaged in activities which are, as applicable, prohibited or cause for the FDA civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other governmental state or regulatory authority to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” or similar policies, set forth in any Health Care Law; (iii) neither the federal health care program. The Company nor any of its Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries has been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under any Health Care Law, including, without limitation, 21 U.S.C. Section 335a; (iv) no claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to the knowledge of the Company, threatened, against the Company, its Subsidiaries or, to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries; (v) neither the Company nor any of its Subsidiaries has not received any notification, correspondence or any other written or oral communication communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental or regulatory entity (authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Agency Administration (“DEA”), the Centers for Medicare and & Medicaid Services, and or the U.S. Department of Health and Human Services Office of Inspector General) , of potential or actual material non-compliance by, or liability of, the Company or any of its Subsidiaries under any Health Care Law; (vi) neither Laws. To 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 entity; and (vii) the manufacture of Company’s and its Subsidiaries products by knowledge, there are no facts or on behalf circumstances that would reasonably be expected to give rise to liability of the Company and/or its Subsidiaries is being conducted in compliance in all material respects with all applicable under any Healthcare Laws, including, without limitation, the FDA’s current good manufacturing practice regulations for products in the United States, and the respective counterparts thereof promulgated by governmental and regulatory authorities in countries outside the United States.