Common use of Compliance with Healthcare Laws Clause in Contracts

Compliance with Healthcare Laws. The Company and each of its subsidiaries and, to the Company’s knowledge, its directors, officers, employees, and agents (while acting in such capacity) are, and at all times since January 1, 2011 have been, in material compliance with, all healthcare laws applicable to the Company and each of its subsidiaries or any of its products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the 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), the Federal Food, Drug, and Cosmetic 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, memorandum, opinion letter, or other issuance which 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, “Healthcare Laws”), and have not engaged in activities which are, as applicable, prohibited or cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. 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 United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company or any of its subsidiaries under any Health Care 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 or any of its subsidiaries under any Healthcare Laws.

Compliance with Healthcare Laws. The Company and each of its subsidiaries andSubsidiaries have been in compliance in all material respects with all applicable healthcare laws, rules and regulations, to the Company’s knowledge, its directors, officers, employees, and agents (while acting in such capacity) are, and at all times since January 1, 2011 have been, in material compliance with, all healthcare laws applicable extent they apply to the Company and each of its subsidiaries or any of its products or current activities, including, but not limited towithout limitation, (i) the FDCA (21 U.S.C. §§ 301 et seq.); (ii) all applicable foreign, federal, state and local healthcare related fraud and abuse laws, including, without limitation, the federal Anti-Kickback kickback Statute (42 U.S.C. § 1320a-7b(b)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the 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 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 (42 U.S.C. §§ §17921 et seq, the exclusion laws .); (42 U.S.C. § 1320a-7), the Federal Food, Drug, iv) comparable state and Cosmetic Act, the Controlled Substances Act, the Public Health Service Act, Medicare local laws; and (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), v) the regulations promulgated pursuant to such laws, and any other state or federal law, accreditation standards, regulation, memorandum, opinion letter, or other issuance which 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 laws (collectively, the “Healthcare Laws”). Neither the Company nor any of its Subsidiaries, and nor to the Company’s knowledge, their officers, directors, employees, agents, have not engaged in activities which are, as applicable, prohibited or cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid Medicaid, or any other state or federal health care healthcare program. The Neither the Company nor any of its Subsidiaries has not received any notification, written notice or other correspondence or any other written or oral communication, including notification of any pending or threatened claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“Action”) from any governmental authoritycourt, includingarbitrator or Governmental Entity or third party alleging that any product, without limitationoperation or activity is in violation of any Healthcare Laws, the United States Food and Drug Administration (“FDA”)and, the Drug Enforcement Administration (“DEA”), the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company or any of its subsidiaries under any Health Care Laws. To to the Company’s knowledge, there are no facts such Action is threatened. Neither the Company nor any of its Subsidiaries is a party to or circumstances has any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement with or imposed by any Governmental Entity. Additionally, neither the Company nor any of its Subsidiaries, nor any of their employees, officers or directors, or to the Company’s knowledge, agents, is or has been excluded, suspended or debarred from participation in any U.S. state or federal healthcare program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that would could reasonably be expected to give rise to liability of the Company result in debarment, suspension, or any of its subsidiaries under any Healthcare Lawsexclusion.

Compliance with Healthcare Laws. The Each of the Company and each of its subsidiaries Subsidiaries and, to the knowledge of the Company’s knowledge, its their directors, officers, employees, employees and agents (while acting in such capacity) areis, and at all times since January 1, 2011 have has been, in material compliance with, with all applicable healthcare laws applicable to the Company and each of its subsidiaries or any of its products or activitiesregulations, including, but not limited towithout limitation, 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 criminal administrative 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 Federal Food, Drug, Food Drug and Cosmetic Act, the Controlled Substances Act, the Public Health Service ActAct (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 imposes requirements on the manufacturing, development, testing, labeling, marketing or distribution of pharmaceutical products, 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 “Healthcare Health Care Laws”); (ii) neither the Company nor any of its Subsidiaries nor, and to the knowledge of the Company, any director, officer, employee, agent, employee or affiliate of the Company or any of its Subsidiaries, have not engaged in activities which arecommitted any act, as applicable, prohibited made any statement or cause failed to make any statement that would reasonably be expected to provide a basis for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid the FDA or any other state governmental or federal health care program. The 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 not 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, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action communication from any governmental authority, or regulatory entity (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 Laws. To 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 knowledge, there are no facts and its Subsidiaries products by or circumstances that would reasonably be expected to give rise to liability on behalf of the Company or any of and/or its subsidiaries under any Healthcare 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. The Company and each of its subsidiaries and, to the Company’s knowledge, its directors, officers, employees, and agents (while acting in such capacity) are, and at all times since January 1, 2011 have been, in material compliance with, all healthcare laws applicable to the Company and each of its subsidiaries or any of its products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the 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), the Federal Food, Drug, and Cosmetic 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, memorandum, opinion letter, or other issuance law which imposes legal 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, “Healthcare Laws”), and have not engaged in activities which are, as applicable, prohibited or cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. 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 United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company or any of its subsidiaries under any Health Care 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 or any of its subsidiaries under any Healthcare Laws.

Compliance with Healthcare Laws. The Company and each of its subsidiaries and, to the Company’s knowledge, its directors, officers, employees, and agents (while acting in such capacity) are, and at all times since January 1, 2011 2010 have been, in material compliance with, all healthcare laws applicable to the Company and each of its subsidiaries or any of its products or activities, including, but not limited to, 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 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), the Federal Food, Drug, and Cosmetic 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, memorandum, opinion letter, or other issuance which 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, “Healthcare Laws”), except with respect to potential non-compliance with the 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 potential liability is not reasonably expected to exceed $100,000 in the aggregate, and have not engaged in activities which are, as applicable, prohibited or cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. 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 United States Food and Drug Administration (“FDA”), the Drug Enforcement Agency Administration (“DEA”), the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company or any of its subsidiaries under any Health Care 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 or any of its subsidiaries under any Healthcare Laws.

Compliance with Healthcare Laws. The Company and each of its subsidiaries and, to the Company’s knowledge, its directors, officers, employees, employees and agents (while acting in such capacity) are, are and at all times since January 1, 2011 have been, been in material compliance with, all healthcare health care laws applicable to the Company and each of its subsidiaries Company, or any of its products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(bSection 1320a 7b(b)), the Anti-Inducement Law (42 U.S.C. Section 1320a 7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal administrative False Claims Law (42 U.S.C. § 1320a-7b(aSection 1320a 7b(a)), the federal Physician Payment Sunshine Act Xxxxx law (42 U.S.C. Section 1320a-7h), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a1395nn), 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), the Federal Food, Drug, and Cosmetic ActAct (21 U.S.C. Section 301 et seq.), the Controlled Substances ActAct (21 U.S.C. Section 801 et seq.), the Public Health Service ActAct (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, memorandum, opinion letter, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, marketing or distribution of pharmaceutical productsadvertising, 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, “Healthcare Health Care Laws”), and have not engaged in activities which are, as applicable, prohibited or cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. 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 United States U.S. Food and Drug Administration (“FDA”)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 (“DEA”)Administration, the U.S. Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or 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 non-compliance by, or liability of, the Company or any of its subsidiaries under any Health Care Laws, except, with respect to any of the foregoing, such as would not, individually or in the aggregate, result in a Material Adverse Change. To the Company’s knowledge, there are no facts or circumstances that would reasonably be expected to give rise to material liability of the Company or any of its subsidiaries under any Healthcare Health Care Laws. The statements with respect to Health Care Laws and the Company’s compliance therewith included in the Company’s Annual Report on Form 10-K filed with the Commission on March 5, 2024, fairly summarize the matters therein described.

Compliance with Healthcare Laws. The Company (i) Each of the Company, its Subsidiaries, their directors and each of its subsidiaries officers and, to the knowledge of the Company’s knowledge, its directors, officers, employees, their employees and agents (while acting in such capacity) areis, and at all times since January 1, 2011 have has been, in material compliance with, with all applicable healthcare laws applicable to the Company and each of its subsidiaries or any of its products or activitiesregulations, including, but not limited towithout limitation, 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 criminal administrative 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 Federal Food, Drug, Food Drug and Cosmetic Act, the Controlled Substances Act, the Public Health Service ActAct (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 imposes requirements on the manufacturing, development, testing, labeling, marketing or distribution of pharmaceutical products, 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 “Healthcare Health Care Laws”); (ii) neither the Company, any of its Subsidiaries, their directors and officers nor, to the knowledge of the Company, any employee, agent or affiliate of the Company or any of its Subsidiaries, have not engaged in activities which arecommitted any act, as applicable, prohibited made any statement or cause failed to make any statement that would reasonably be expected to provide a basis for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid the FDA or any other state governmental or federal health care program. The 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, any of its Subsidiaries, their directors and officers nor, to the knowledge of the Company, any employee, agent or affiliate of the Company or any of its Subsidiaries has not 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 debarment or exclusion are pending or, to the knowledge of the Company, threatened, against the Company, its Subsidiaries, their directors and officers or, to the knowledge of the Company, any 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, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action communication from any governmental authority, or regulatory entity (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 non-compliance by, or liability of, the Company or any of its subsidiaries Subsidiaries under any Health Care Laws. To 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 knowledge, there are no facts and its Subsidiaries products by or circumstances that would reasonably be expected to give rise to liability on behalf of the Company and/or its Subsidiaries is being conducted in compliance in all 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 any of its subsidiaries under any Healthcare Lawsin part, individually or in the aggregate, to result in a Material Adverse Effect.

Compliance with Healthcare Laws. The Company and each of its subsidiaries and, to the Company’s knowledge, its directors, officers, employees, and agents (while acting in such capacity) are, and at all times since January 1, 2011 2017 have been, in material compliance with, with all healthcare laws to the extent applicable to the Company and each of its subsidiaries or any of its products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the 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 seqAct, the exclusion laws (42 U.S.C. § 1320a-7), the Federal Food, Drug, and Cosmetic 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, memorandum, opinion letter, or other issuance law which imposes legal requirements on the manufacturing, development, testing, labeling, marketing marketing, import, export 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, health data privacy and security, licensure, accreditation or any other aspect of providing health care or pharmaceutical services (collectively, “Healthcare Laws”), and have not engaged in activities which are, as applicable, prohibited or cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. 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 United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company or any of its subsidiaries under any Health Care 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 or any of its subsidiaries under any Healthcare Laws.

Compliance with Healthcare Laws. The Company and each of its subsidiaries and, to the Company’s knowledge, its directors, officers, employees, and agents (while acting in such capacity) are, and at all times since January 1, 2011 2015 have been, in material compliance with, all healthcare laws applicable to the Company and each of its subsidiaries or any of its products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the 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), the Federal Food, Drug, and Cosmetic 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, memorandum, opinion letter, or other issuance which 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, “Healthcare Laws”), and have not engaged in activities which are, as applicable, prohibited or cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. 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 United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company or any of its subsidiaries under any Health Care 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 or any of its subsidiaries under any Healthcare Laws.

Compliance with Healthcare Laws. The Company and each of its subsidiaries andsubsidiaries: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of all applicable health care laws, to including Title XVIII of the Company’s knowledgeSocial Security Act, its directors, officers, employees, and agents (while acting in such capacity) are, and at all times since January 1, 2011 have been, in material compliance with, all healthcare laws applicable to the Company and each of its subsidiaries or any of its products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. §§ 1320a-7b(b1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); the civil False Claims Act (Act, 31 U.S.C. §§ 3729 et seq.), ; the criminal False Claims Law (Act 42 U.S.C. § 1320a-7b(a)); the criminal laws relating to health care fraud and abuse, including 18 U.S.C. Sections 286 and 287 and the federal Physician Payment Sunshine Act (42 U.S.C. Section 1320a-7h), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (1996, 42 U.S.C. §§ 1320d et seq., (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; the Physician Payments Xxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (Act, 42 U.S.C. §§ 17921 et seq, the exclusion laws (42 U.S.C. § 1320a-7), .; the Federal Food, Drug, and Cosmetic Act, the Controlled Substances Act, 21 U.S.C. §§ 301 et seq.; the Public Health Service Act, Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws, ; and any other state similar applicable federal, state, local or federal lawforeign laws and regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on the manufacturingtesting, development, testingmanufacture, labelingpackaging, marketing processing, use, sale, distribution, storage, import, export or distribution disposal of pharmaceutical products, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, any of 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 Company’s product candidates (collectively, the “Healthcare Health Care Laws”), and have not engaged in activities which are, as applicable, prohibited or cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. The Company ; (ii) has not received any notificationUnited States Food and Drug Administration 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 non-compliance with (A) any Health Care Laws or (B) any licenses, approvals, clearances, exemptions, permits, registrations, authorizations, and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and the Company is not in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) has fulfilled and performed all of its material obligations with respect to the Regulatory Authorizations required to conduct its business as currently conducted and, to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other written or oral communication, including notification material impairment of the rights of the holder of any pending or threatened such Regulatory Authorization; (v) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any governmental authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company authority including any Regulatory Agency or any other third party alleging a material violation of its subsidiaries under any Health Care Laws. To Laws or Regulatory Authorizations or limiting, suspending, modifying, or revoking any material Regulatory Authorizations, and has no knowledge that any governmental authority including any Regulatory Agencies or any other third party is considering any Proceeding; (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 Regulatory Authorizations (“Reports”) required to conduct its business as currently conducted and that all such Reports were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (vii) along with its employees, officers and directors, and to the Company’s knowledge, there are no facts independent contractors and agents, is not a party to or circumstances that would reasonably be expected has any ongoing reporting obligations pursuant to give rise 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 authority including any Regulatory Agencies; and (viii) along with its employees, officers and directors, and to liability of the Company Company’s knowledge, independent contractors and agents, has not been excluded, suspended or debarred from, or otherwise rendered ineligible for participation in any of its subsidiaries under any Healthcare Lawsgovernment health care program or human clinical research.

Compliance with Healthcare Laws. The Company and each of its subsidiaries and, to the Company’s knowledge, its directors, officers, employees, employees and agents (while acting in such capacity) are, are and at all times since January 1, 2011 have been, been in material compliance with, all healthcare health care laws applicable to the Company and each of its subsidiaries Company, or any of its products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(bSection 1320a 7b(b)), the Anti-Inducement Law (42 U.S.C. Section 1320a 7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal administrative False Claims Law (42 U.S.C. § 1320a-7b(aSection 1320a 7b(a)), the federal Physician Payment Sunshine Act Xxxxx law (42 U.S.C. Section 1320a-7h), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a1395nn), 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), the Federal Food, Drug, and Cosmetic ActAct (21 U.S.C. Section 301 et seq.), the Controlled Substances ActAct (21 U.S.C. Section 801 et seq.), the Public Health Service ActAct (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, memorandum, opinion letter, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, marketing or distribution of pharmaceutical productsadvertising, 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, “Healthcare Health Care Laws”), and have not engaged in activities which are, as applicable, prohibited or cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. 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 United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the U.S. Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or 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 non-compliance by, or liability of, the Company or any of its subsidiaries under any Health Care Laws, except, with respect to any of the foregoing, such as would not, individually or in the aggregate, result in a Material Adverse Change. To the Company’s knowledge, there are no facts or circumstances that would reasonably be expected to give rise to material liability of the Company or any of its subsidiaries under any Healthcare Health Care Laws. The statements with respect to Health Care Laws and the Company’s compliance therewith included in the Company’s Annual Report on Form 10-K filed with the Commission on March 26, 2024, fairly summarize the matters therein described.

Compliance with Healthcare Laws. The Company and each of its subsidiaries andsubsidiaries: (i) has operated and currently operates its business in compliance in all material respects with applicable provisions of all applicable health care laws, to including Title XVIII of the Company’s knowledgeSocial Security Act, its directors, officers, employees, and agents (while acting in such capacity) are, and at all times since January 1, 2011 have been, in material compliance with, all healthcare laws applicable to the Company and each of its subsidiaries or any of its products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. §§ 1320a-7b(b1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the Federal Axxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x); the civil False Claims Act (Act, 31 U.S.C. §§ 3729 et seq.), ; the criminal False Claims Law (Act 42 U.S.C. § 1320a-7b(a)); the criminal laws relating to health care fraud and abuse, including 18 U.S.C. Sections 286 and 287 and the federal Physician Payment Sunshine Act (42 U.S.C. Section 1320a-7h), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (1996, 42 U.S.C. §§ 1320d et seq., (“HIPAA”); the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; the Physician Payments Sxxxxxxx Xxx, 00 X.X.X. § 0000x-0x; the exclusion law, 42 U.S.C. § 1320a-7; HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (Act, 42 U.S.C. §§ 17921 et seq, the exclusion laws (42 U.S.C. § 1320a-7), .; the Federal Food, Drug, and Cosmetic Act, the Controlled Substances Act, 21 U.S.C. §§ 301 et seq.; the Public Health Service Act, Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), 42 U.S.C. §§ 201 et seq.; the regulations promulgated pursuant to such laws, ; and any other state similar applicable federal, state, local or federal lawforeign laws and regulations of any governmental authority including the Regulatory Agencies applicable to the ownership, accreditation standards, regulation, memorandum, opinion letter, or other issuance which imposes requirements on the manufacturingtesting, development, testingmanufacture, labelingpackaging, marketing processing, use, sale, distribution, storage, import, export or distribution disposal of pharmaceutical products, kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, any of 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 Company’s product candidates (collectively, the “Healthcare Health Care Laws”), and have not engaged in activities which are, as applicable, prohibited or cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. The Company ; (ii) has not received any notificationUnited States Food and Drug Administration 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 non-compliance with (A) any Health Care Laws or (B) any licenses, approvals, clearances, exemptions, permits, registrations, authorizations, and supplements or amendments thereto required by any such Health Care Laws (“Regulatory Authorizations”); (iii) possesses all Regulatory Authorizations required to conduct its business as currently conducted and such Regulatory Authorizations are valid and in full force and effect and the Company is not in violation, in any material respect, of any term of any such Regulatory Authorizations; (iv) has fulfilled and performed all of its material obligations with respect to the Regulatory Authorizations required to conduct its business as currently conducted and, to the Company’s knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other written or oral communication, including notification material impairment of the rights of the holder of any pending or threatened such Regulatory Authorization; (v) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action (“Proceeding”) from any governmental authority, including, without limitation, the United States Food and Drug Administration (“FDA”), the Drug Enforcement Administration (“DEA”), the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company authority including any Regulatory Agency or any other third party alleging a material violation of its subsidiaries under any Health Care Laws. To Laws or Regulatory Authorizations or limiting, suspending, modifying, or revoking any material Regulatory Authorizations, and has no knowledge that any governmental authority including any Regulatory Agencies or any other third party is considering any Proceeding; (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 Regulatory Authorizations (“Reports”) required to conduct its business as currently conducted and that all such Reports were materially complete and correct on the date filed (or were materially corrected or supplemented by a subsequent submission); (vii) along with its employees, officers and directors, and to the Company’s knowledge, there are no facts independent contractors and agents, is not a party to or circumstances that would reasonably be expected has any ongoing reporting obligations pursuant to give rise 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 authority including any Regulatory Agencies; and (viii) along with its employees, officers and directors, and to liability of the Company Company’s knowledge, independent contractors and agents, has not been excluded, suspended or debarred from, or otherwise rendered ineligible for participation in any of its subsidiaries under any Healthcare Lawsgovernment health care program or human clinical research.

Compliance with Healthcare Laws. The Company and each of its subsidiaries and, to the Company’s knowledge, its directors, officers, employees, and agents (while acting in such capacity) are, and at all times since January 1, 2011 2010 have been, in material compliance with, all healthcare laws applicable to the Company and each of its subsidiaries or any of its products or activities, including, but not limited to, 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 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), the Federal Food, Drug, and Cosmetic 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, memorandum, opinion letter, or other issuance which 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, “Healthcare Laws”), and have not engaged in activities which are, as applicable, prohibited or cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. 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 United States Food and Drug Administration (“FDA”), the Drug Enforcement Agency Administration (“DEA”), the Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or the U.S. Department of Health and Human Services Office of Inspector General, of potential or actual non-compliance by, or liability of, the Company or any of its subsidiaries under any Health Care 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 or any of its subsidiaries under any Healthcare Laws.

Compliance with Healthcare Laws. The Company and each of its subsidiaries and, to the Company’s knowledge, its directors, officers, employees, employees and agents (while acting in such capacity) are, are and at all times since January 1, 2011 have been, been in material compliance with, all healthcare health care laws applicable to the Company and each of its subsidiaries Company, or any of its products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(bSection 1320a 7b(b)), the Anti-Inducement Law (42 U.S.C. Section 1320a 7a(a)(5)), the civil False Claims Act (31 U.S.C. §§ Section 3729 et seq.), the criminal administrative False Claims Law (42 U.S.C. § 1320a-7b(aSection 1320a 7b(a)), the federal Physician Payment Sunshine Act Xxxxx law (42 U.S.C. Section 1320a-7h), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a1395nn), 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), the Federal Food, Drug, and Cosmetic ActAct (21 U.S.C. Section 301 et seq.), the Controlled Substances ActAct (21 U.S.C. Section 801 et seq.), the Public Health Service ActAct (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, memorandum, opinion letter, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, marketing or distribution of pharmaceutical productsadvertising, 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, “Healthcare Health Care Laws”), and have not engaged in activities which are, as applicable, prohibited or cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid or any other state or federal health care program. 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 United States U.S. Food and Drug Administration (“FDA”)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 (“DEA”)Administration, the U.S. Centers for Medicare & Medicaid Services, the U.S. Department of Justice, or 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 non-compliance by, or liability of, the Company or any of its subsidiaries under any Health Care Laws, except, with respect to any of the foregoing, such as would not, individually or in the aggregate, result in a Material Adverse Change. To the Company’s knowledge, there are no facts or circumstances that would reasonably be expected to give rise to material liability of the Company or any of its subsidiaries under any Healthcare Health Care Laws. The statements with respect to Health Care Laws and the Company’s compliance therewith included in the Company’s Annual Report on Form 10-K filed with the Commission on October 14, 2022, fairly summarize the matters therein described.