Common use of Health Care Laws Clause in Contracts

Health Care Laws. The Company (i) is and at all times has been in compliance in all material respects with all applicable Health Care Laws, rules and regulations in the United States and Australia or any other jurisdiction, including, without limitation the Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et seq.), all applicable federal, state, local and all foreign civil and criminal laws relating to health care fraud and abuse, including but not limited to the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), criminal false statements (42 U.S.C. §1320a-7b(a)), the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§ 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil monetary penalties law (42 U.S.C. §1320a-7a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. §§ 17921 et seq.), the Patient Protection and Affordable Care Act (Pub. Law 111-148), as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (Pub. Law 111-152), the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices, and all other local, state, federal, national, supranational and foreign laws applicable to the regulation of the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company (collectively, the “Health Care Laws”); (ii) has not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting material noncompliance with any Health Care Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Health Care Laws (“Authorizations ”); (iii) possesses all necessary Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (iv) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws or Authorizations nor to the knowledge of the Company, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) has not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has not, nor have any of its officers or directors, nor, to the knowledge of the Company, have any of its employees, been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or subject to a governmental inquiry, investigation, proceeding, or other any other Action that could reasonably be expected to result in debarment, suspension, or exclusion; and (viii) is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Health Care Laws. The Company (i) is and at all times has been in compliance in all material respects with all applicable Health Care Laws, rules and regulations in the United States and Australia Canada or any other jurisdiction, including, without limitation the Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et seq.), all applicable federal, state, local and all foreign civil and criminal laws relating to health care fraud and abuse, including but not limited to the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), criminal false statements (42 U.S.C. §1320a-7b(a)), the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§ 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil monetary penalties law (42 U.S.C. §1320a-7a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. §§ 17921 et seq.), the Patient Protection and Affordable Care Act (Pub. Law 111-148), as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (Pub. Law 111-152), the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices, and all other local, state, federal, national, supranational and foreign laws applicable to the regulation of the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company (collectively, the “Health Care Laws”); (ii) has not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting material noncompliance with any Health Care Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Health Care Laws (“Authorizations Authorizations”); (iii) possesses all necessary Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (iv) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws or Authorizations nor to the knowledge of the Company, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) has not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has not, nor have any of its officers or directors, nor, to the knowledge of the Company, have any of its employees, been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or subject to a governmental inquiry, investigation, proceeding, or other any other Action that could reasonably be expected to result in debarment, suspension, or exclusion; and (viii) is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Health Care Laws. The Company and, to the Knowledge of the Company, its directors, officers, employees, and agents (iwhile acting in such capacity) is are, and at all times has been since January 1, 2003 were, in material compliance in with, all material respects with all health care laws applicable Health Care Laws, rules and regulations in to the United States and Australia Company or any other jurisdictionof its activities, including, without limitation the Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et seq.), all applicable federal, state, local and all foreign civil and criminal laws relating to health care fraud and abuse, including but not limited to to, the federal Anti-Kickback Statute (42 U.S.C. §Section 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.), criminal false statements the administrative False Claims Law (42 U.S.C. §Section 1320a-7b(a)), the health care fraud criminal provisions under Xxxxx law (42 U.S.C. Section 1395nn), the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”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. §§ 1320d Section 17921 et seq.), the exclusion laws (42 U.S.C. § Section 1320a-7), the U.S. Physician Payments Sunshine 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. § 1320a-7h), the civil monetary penalties law (42 U.S.C. §1320a-7aSection 201 et seq.), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. §§ 17921 et seq.), the Patient Protection and Affordable Care Act (Pub. Law 111-148), as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (Pub. Law 111-152), the regulations promulgated pursuant to such laws, and any successor government programs and comparable similar or related state laws, regulations relating to Good Clinical Practices and Good Laboratory Practicesrules, and all other local, state, federal, national, supranational and foreign laws applicable to the regulation of the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company regulations (collectively, the “Health Care Laws”); (ii) . The Company has not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting material noncompliance with any Health Care Laws notification, correspondence or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements other written or amendments thereto required by any such Health Care Laws (“Authorizations ”); (iii) possesses all necessary Authorizations and such Authorizations are valid and in full force and effect and are not in material violation oral communication of any term of any such Authorizations; (iv) has not received written notice of any material pending or threatened claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws or Authorizations nor to the knowledge of the Company, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) has not received from any written notice that any court or arbitrator or governmental or regulatory authority has takenauthority, is taking or intends to takeincluding, action to limit, suspend, materially modify or revoke any Authorizations nor is any such without limitation, suspensionthe FDA, modification the United States Federal Trade Commission, the United States Drug Enforcement Administration, CMS, HHS’s Office of Inspector General, the United States Department of Justice and state Attorneys General or revocation threatened; (vi) has filedsimilar agencies of potential or actual non-compliance by, obtainedor liability of, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the Company under any Health Care Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has not, nor have any of its officers or directors, nor, to the knowledge of the Company, have any of its employees, been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or subject to a governmental inquiry, investigation, proceeding, or other any other Action that could reasonably be expected to result in debarment, suspension, or exclusion; and (viii) is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityLaws.

Health Care Laws. The Company (i) is and at all times has been its subsidiaries are in compliance in with applicable Health Care Laws (defined herein), including, but not limited to, the rules and regulations of the FDA, and all material respects with all applicable Health Care Laws, except for such noncompliance that would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect. For purposes of this Agreement, “Health Care Laws” shall mean all applicable statutes, rules and regulations in applicable to the United States and Australia or any other jurisdiction, including, without limitation conduct of the Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et seq.), all applicable federal, state, local and all foreign civil and criminal laws relating to health care fraud and abuseCompany’s business, including but not limited to the testing, development, registration, licensure, application approval, manufacture, packaging, labeling, processing, use, distribution, marketing, advertising, promotion, sale, offer for sale, recordkeeping, filing of reports, storage, import, export or disposal of any product or product candidate under development by the Company, including, without limitation, Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395hhh (the Medicare statute); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396v (the Medicaid statute); the federal Anti-Kickback kickback Statute (42 U.S.C. §§ 1320a-7b(b)), the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), all state drug transparency and pricing reporting laws, the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the criminal false statements False Claims Act (42 U.S.C. §§ 1320a-7b(a)), the applicable criminal laws relating to health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§ 1320d et seq.)abuse, the exclusion laws (42 U.S.C. § 1320a-7), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil monetary penalties law (42 U.S.C. §§ 1320a-7a), Medicare the exclusion law, (Title XVIII of the Social Security Act42 U.S.C. § 1320a-7), Medicaid the Health Insurance Portability and Accountability Act of 1996 (Title XIX of the Social Security Act42 U.S.C. §§ 1320d et seq.), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. §§ 17921 et seq.) (“HIPAA”), the Patient Protection Federal Food, Drug, and Affordable Care Cosmetic Act (Pub. Law 111-14821 U.S.C. §§ 301 et seq.), as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (Pub. Law 111-152), the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices, and all other local, state, similar federal, national, supranational state and foreign local laws and regulations of any governmental authority including the regulatory agencies applicable to the regulation of the ownership, testing, development, registration, licensure, application approval, manufacture, packaging, labeling, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, recordkeeping, filing of reports, storage, import, export or disposal of any product manufactured or distributed product candidate under development by or for the Company. Neither the Company (collectivelynor any of its subsidiaries is a party to or 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 imposed by any governmental authority. Neither the “Health Care Laws”); (ii) Company nor any of its subsidiaries has not received any written notification, correspondence or any other written communication, including, without limitation, any Form FDA 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting material noncompliance with any Health Care Laws the FDA or any licensessimilar regulatory authority, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Health Care Laws (“Authorizations ”); (iii) possesses all necessary Authorizations and such Authorizations are valid and in full force and effect and are not in material violation written notification of any term of any such Authorizations; (iv) has not received written notice of any claimpending or, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws or Authorizations nor to the knowledge of the Company’s knowledge, is any such threatened claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) has not received action, from any written notice that any court governmental authority of potential or arbitrator actual material non-compliance by, or governmental material liability of, the Company or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by its subsidiaries under any Health Care Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has not, nor have any of its officers or directors, nor, to the knowledge of the Company, have any of its employees, been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or subject to a governmental inquiry, investigation, proceeding, or other any other Action that could reasonably be expected to result in debarment, suspension, or exclusion; and (viii) is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityLaws.

Health Care Laws. The Neither the Company nor any of its subsidiaries, nor any of their respective business operations, is in violation of any Health Care Laws (as defined below), except as would not reasonably be expected to result in a Material Adverse Effect. “Health Care Laws” means (i) is all federal and at all times has been in compliance in all material respects with all applicable Health Care Laws, rules state fraud and regulations in the United States and Australia or any other jurisdictionabuse laws, including, without limitation the Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et seq.), all applicable federal, state, local and all foreign civil and criminal laws relating to health care fraud and abuse, including but not limited to to, the federal Anti-Kickback Statute (as codified in 42 U.S.C. §1320a-7b(b)), the Xxxxx Law (as codified in 42 U.S.C. §1395nn), the Anti-Inducement Law (as codified in 42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (as codified in 31 U.S.C. §§ 3729 et seq.), criminal false statements the administrative False Claims Law (as codified in 42 U.S.C. §§ 1320a-7b(a)), the health care fraud criminal provisions under exclusion laws (as codified in 42 U.S.C. § 1320a-7), the civil monetary penalty laws (as codified in 42 U.S.C. § 1320a-7a) and the regulations promulgated pursuant to such laws; (ii) the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (as codified in 42 U.S.C. §§ 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil monetary penalties law (42 U.S.C. §1320a-7a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), HIPAA, ) as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (as codified in 42 U.S.C. §§ 17921 et seq.), the Patient Protection regulations promulgated thereunder and Affordable Care comparable state privacy and security laws, (iii) Medicare (Title XVIII of the Social Security Act) and the regulations promulgated thereunder; (iv) Medicaid (Title XIX of the Social Security Act) and the regulations promulgated thereunder; (v) the Federal Food, Drug, and Cosmetic Act (Pub. Law 111-148), as amended by the Health Care codified in 21 U.S.C. § 301 et seq.) and Education Affordability Reconciliation Act of 2010 (Pub. Law 111-152), the regulations promulgated pursuant to such laws, thereto (the “FDCA”); (vi) the Clinical Laboratory Improvement Amendments of 1988 (as codified in 42 U.S.C. § 263a) and the regulations promulgated pursuant thereto; and (vii) any successor government programs and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices, and all other local, state, federal, nationalor foreign laws, supranational regulations, accreditation standards, manual provisions, policies and foreign laws administrative guidance of any Governmental Entity that impose legally binding requirements (including, without limitation, requirements relating to quality and safety) applicable to the regulation any products, products under development, operations and activities of the ownershipCompany or any of its subsidiaries. Except as described in the Registration Statement, testingthe General Disclosure Package and the Prospectus, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by or for neither the Company (collectively, the “Health Care Laws”); (ii) nor any of its subsidiaries has not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting material noncompliance with any Health Care Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Health Care Laws (“Authorizations ”); (iii) possesses all necessary Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (iv) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration investigation, arbitration, adverse finding, warning letter, untitled letter, correspondence, or other similar action from any court or arbitrator or governmental or regulatory authority or third party Governmental Entity alleging that any product, product under development, operation or activity of the Company or any of its subsidiaries is in material violation of any applicable Health Care Laws or Authorizations nor Law and to the knowledge of the Company, is no Governmental Entity has threatened or intends to make or take any such claim, litigation, arbitration, action, suit, investigation or proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) has not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has not, nor have any of its officers or directors, nor, to the knowledge of the Company, have any of its employees, been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or subject to a governmental inquiry, investigation, proceeding, or other any other Action that could reasonably be expected to result in debarment, suspension, or exclusion; and (viii) is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Health Care Laws. The Company (i) has operated and currently is and at all times has been in compliance in all material respects with all applicable Health Care Lawshealth care laws, rules and regulations to the extent they apply to the Company and its current activities (except where such failure to operate or non-compliance would not, singly or in the United States and Australia or any other jurisdictionaggregate, result in a Material Adverse Effect), including, without limitation limitation, (i) the Federal Federal, Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.), ; (ii) all applicable federal, state, local and all applicable foreign civil and criminal laws relating to health care healthcare related fraud and abuseabuse laws, including but not limited to including, without limitation, the federal Anti-Kickback kickback Statute (42 U.S.C. §§ 1320a-7b(b)), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the criminal false statements False Claims Law (42 U.S.C. §§ 1320a-7b(a)), all criminal laws relating to healthcare fraud and abuse, including but not limited to 18 U.S.C. Sections 286 and 287, the health care healthcare fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§ Section 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), and the civil monetary penalties law (42 U.S.C. §§ 1320a-7a), Medicare ; (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. §§ Section 17921 et seq.), the Patient Protection and Affordable Care Act ; (Pub. Law 111-148), as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (Pub. Law 111-152), iv) the regulations promulgated pursuant to such laws, ; and (v) any successor government programs and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices, and all other similar local, state, federal, national, supranational and or foreign laws applicable to the regulation of the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company (collectively, the “Health Care Laws”); (ii) has not received . Neither the Company, nor to the Company’s knowledge, any notice of its officers, directors, employees or agents have engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting material noncompliance with any Health Care Laws Medicare, Medicaid, or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements other state or amendments thereto required by any such Health Care Laws (“Authorizations ”); (iii) possesses all necessary Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (iv) federal healthcare program. The Company has not received written notice or other correspondence of any claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation investigation, arbitration or other action (“Action”) from any court or arbitrator or governmental or regulatory authority Governmental Entity or third party alleging that any product operation or activity is in material violation of any Health Care Laws or Authorizations nor Laws, and, to the knowledge of the Company’s knowledge, is any no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened; (v) has . The Company is not received a party to and does not have any written notice that ongoing reporting obligations pursuant to any court corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required similar agreement imposed by any Health Care Laws or Authorizations and that all such reportsGovernmental Entity. Additionally, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has not, nor have any of its officers or directors, nor, to the knowledge of neither the Company, have nor to the Company’s knowledge, any of its employees, officers or directors, has been excluded, suspended suspended, disqualified, or debarred from participation in any U.S. state or federal health care program or human clinical research or or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other any other Action similar action that could reasonably be expected to result in debarment, suspension, disqualification, or exclusion; and (viii) is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.

Health Care Laws. The Except as described in the Registration Statement, the General Disclosure Package and the Prospectus, neither the Company (i) nor any of its business operations is and at all times has been in compliance in all material respects with all applicable violation of any Health Care Laws, rules and regulations except where the failure to be in compliance would not, individually or in the United States and Australia or any other jurisdictionaggregate, includingresult in a Material Adverse Effect. For purposes of this Agreement, without limitation “Health Care Laws” means (A) the Federal Food, Drug Drug, and Cosmetic Act Act, and the regulations promulgated thereunder, (21 U.S.C. §301 et seq.), all applicable federal, state, local B) federal and all foreign civil and criminal laws relating to health care state fraud and abuseabuse laws, including but not limited to including, the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the Sxxxx Law (42 U.S.C. §1395nn), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), criminal false statements Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code and the regulations promulgated pursuant to such statutes, (42 U.S.C. §1320a-7b(a)), C) the health care fraud criminal administrative simplification provisions under of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”18 U.S.C. §§669, 1035, 1347 and 1518; 42 U.S.C. §1320d et seq.) and the regulations promulgated thereunder, (D) Titles XVII (42 U.S.C. §§ 1320d 1395 et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil monetary penalties law ) and XIX (42 U.S.C. §1320a-7a), Medicare (Title XVIII 1396 et seq.) of the Social Security Act)Act and the regulations promulgated thereunder, Medicaid (Title XIX of E) the Social Security Act)Medicare Prescription Drug, HIPAAImprovement, as amended by the Health Information Technology for Economic and Clinical Health Modernization Act of 2009 2003 (42 U.S.C. §§ 17921 1395w-101 et seq.)) and the regulations promulgated thereunder, (F) the Patient Protection and Affordable Care Act Act, (Pub. Law 111-148)G) all statutes, as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (Pub. Law 111-152), the rules or regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices, and all other local, state, federal, national, supranational and foreign laws applicable to the regulation of the ownership, testing, development, manufacture, quality, safety, accreditation, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company and (collectivelyH) any and all other health care laws and regulations applicable to the business of the Company as currently conducted by it as described in the Registration Statement, the “Health Care Laws”); General Disclosure Package and the Prospectus, each of (iiA) has not received any notice through (H) as may be amended from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting material noncompliance with any Health Care Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Health Care Laws (“Authorizations ”); (iii) possesses all necessary Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (iv) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws or Authorizations nor time to the knowledge of the Company, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) has not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has not, nor have any of its officers or directors, nor, to the knowledge of the Company, have any of its employees, been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or subject to a governmental inquiry, investigation, proceeding, or other any other Action that could reasonably be expected to result in debarment, suspension, or exclusion; and (viii) is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authoritytime.

Health Care Laws. The Company Except as described in the Registration Statement and the Prospectus, and except as would not, individually or in the aggregate, have a Material Adverse Effect: (i) is neither the Company nor any of the Subsidiaries has received any unresolved FDA Form 483, notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the U.S. Food and at all times has been in compliance in all material respects with all applicable Health Care LawsDrug Administration (“FDA”), rules and regulations in the United States and Australia or any other jurisdictioncourt or arbitrator or federal, includingstate, without limitation local or foreign governmental or regulatory authority, alleging or asserting noncompliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.) (the “FFDCA”), all ; (ii) the Company and each of the Subsidiaries is and has been in compliance with applicable federal, state, local and all foreign civil and criminal laws relating to health care fraud and abuselaws, including but not limited to without limitation, the FFDCA, the federal Anti-Kickback Statute (42 U.S.C. §§ 1320a-7b(b)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), criminal false statements the administrative False Claims Law (42 U.S.C. §§ 1320a-7b(a)), the health care fraud criminal provisions under Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§ 1320d et seq.), the exclusion laws laws, Social Security Act § 1128 (42 U.S.C. § 1320a-7), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil monetary penalties law (42 U.S.C. §1320a-7a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. §§ 17921 et seq.), the Patient Protection and Affordable Care Act of 2010 (Pub. Public Law 111-148), as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (Pub. Public Law 111-152), and the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices, and all other local, state, federal, national, supranational and foreign laws applicable laws, manual provisions, policies and administrative guidance relating to the regulation of the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company (collectively, the “Health Care Laws”); (iiiii) has not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting material noncompliance with any Health Care Laws or any the Company and each of the Subsidiaries possesses all licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations permits and supplements or amendments thereto required by any such Health Care Laws and/or to carry on its businesses as now or proposed to be conducted (“Authorizations Authorizations”); (iii) possesses all necessary Authorizations and such Authorizations are valid and in full force and effect and are the Company is not in material violation of any term of any such Authorizations; (iv) neither the Company nor any of the Subsidiaries has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws or Authorizations nor to the knowledge of the Company, is any such ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatenedfrom any U.S. or non-U.S. federal, state, local or other governmental or regulatory authority, governmental or regulatory agency or body, court, arbitrator or self-regulatory organization (each, a “Governmental Authority”) or third party alleging that any product operation or activity is in violation of any Health Care Laws or Authorizations or has any knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) neither the Company nor any of the Subsidiaries has not received any written notice that any court or arbitrator or governmental or regulatory authority Governmental Authority has taken, is taking or intends to take, take action to limit, suspend, materially modify or revoke any Authorizations nor is or has any knowledge that any such limitation, suspension, modification or revocation threatenedGovernmental Authority is considering such action; (vi) the Company and each of the Subsidiaries has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete complete, correct and accurate in all material respects not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has not, neither the Company nor have any of its officers the Subsidiaries has, either voluntarily or directorsinvoluntarily, norinitiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the knowledge of the Company’s knowledge, have no third party has initiated or conducted any of its employees, been excluded, suspended such notice or debarred from participation in any U.S. state or federal health care program or human clinical research or subject to a governmental inquiry, investigation, proceeding, or other any other Action that could reasonably be expected to result in debarment, suspension, or exclusion; and (viii) is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authorityaction.

Health Care Laws. The Company (i) is and at all times has been in compliance in all material respects with all applicable Health Care Laws, rules and regulations in the United States and Australia Canada or any other jurisdiction, including, without limitation the Federal Food, Drug and Cosmetic Act (21 U.S.C. §301 et seq.), all applicable federal, state, local and all foreign civil and criminal laws relating to health care fraud and abuse, including but not limited to the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), criminal false statements (42 U.S.C. §1320a-7b(a)), the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§ 1320d et seq.), the exclusion laws (42 U.S.C. § 1320a-7), the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), the civil monetary penalties law (42 U.S.C. §1320a-7a), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. §§ 17921 et seq.), the Patient Protection and Affordable Care Act (Pub. Law 111-148), as amended by the Health Care and Education Affordability Reconciliation Act of 2010 (Pub. Law 111-152), the regulations promulgated pursuant to such laws, and any successor government programs and comparable state laws, regulations relating to Good Clinical Practices and Good Laboratory Practices, and all other local, state, federal, national, supranational and foreign laws applicable to the regulation of the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, advertising, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by or for the Company (collectively, the “Health Care Laws”); (ii) has not received any notice from any court or arbitrator or governmental or regulatory authority or third party alleging or asserting material noncompliance with any Health Care Laws or any licenses, exemptions, certificates, approvals, clearances, authorizations, permits, registrations and supplements or amendments thereto required by any such Health Care Laws (“Authorizations Authorizations”); (iii) possesses all necessary Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any such Authorizations; (iv) has not received written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws or Authorizations nor to the knowledge of the Company, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened; (v) has not received any written notice that any court or arbitrator or governmental or regulatory authority has taken, is taking or intends to take, action to limit, suspend, materially modify or revoke any Authorizations nor is any such limitation, suspension, modification or revocation threatened; (vi) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate in all material respects on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) has not, nor have any of its officers or directors, nor, to the knowledge of the Company, have any of its employees, been excluded, suspended or debarred from participation in any U.S. state or federal health care program or human clinical research or subject to a governmental inquiry, investigation, proceeding, or other any other Action that could reasonably be expected to result in debarment, suspension, or exclusion; and (viii) is not a party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.