expected to have a Material Adverse Effect. For purposes of this Agreement, Health Care Laws shall mean, to the extent applicable to the operations of the Company and its
subsidiaries, all local, state, federal and foreign health care laws including but not limited to: (i) the FDCA; (ii) all applicable federal, state and local health care fraud and abuse laws, including, without limitation, the
Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal False Claims Act and False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286, 287, 1347 and 1349, the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (42 U.S.C.
Section 1320d et seq.), the Stark Law (42 U.S.C. Section 1395nn), the Civil Monetary Penalties Law (42 U.S.C. Sections 1320a-7a), the Exclusions Law (42 U.S.C.
Section 1320a-7), and the transparency reporting requirements under 42 U.S.C. Section 1320a-7h; (iii) HIPAA, as amended by the Health Information
Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.) and all other applicable laws related to health information or medical records; (iv) the Medicare (Title XVIII of the Social Security Act) and Medicaid
(Title XIX of the Social Security Act) statutes and applicable laws governing government funded or sponsored health care programs; (v) licensure, quality, safety and accreditation requirements under applicable federal, state, local or foreign
laws or healthcare-related regulatory bodies; (vi) any rules and regulations promulgated pursuant to the statutes listed herein, and any other applicable federal, state or local health care laws; and (vii) the applicable directives
promulgated pursuant to such Health Care Laws and any applicable state or foreign counterpart thereof, each as amended from time to time. Neither the Company nor its subsidiaries nor, to the knowledge of the Company, any agent has received written
notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority or third party alleging that any product, service, operation or
activity is in material violation of any Health Care Laws, and the Company has no knowledge that any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened. Neither the Company nor its
subsidiaries nor, to the knowledge of the Company, any agent is a party to or has any ongoing reporting obligations pursuant to any corporate integrity agreements, monitoring agreements, deferred or
non-prosecution agreements, consent decrees, settlement orders, plan of correction or similar agreements with or imposed by any governmental or regulatory authority. Additionally, neither the Company nor its
subsidiaries nor their employees, officers, directors, or, to the Companys knowledge, agents, has been excluded, suspended, debarred or disqualified from participation in any governmental health care 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 could reasonably be expected to result in any such exclusion, suspension, debarment or disqualification.
(aa) Regulatory Filings. The Company and its subsidiaries and, to the knowledge of the Company, its agents, have filed,
maintained or submitted all material reports, documents, declarations, forms, notices, applications, records, claims, submissions and supplements or amendments as required by the Applicable Laws, Authorizations or Health Care Laws, as applicable,
and all such material reports, documents, declarations, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material respects (or were corrected or supplemented
by a subsequent submission).
(bb) No Undisclosed Relationships. No relationship, direct or indirect, exists between
or among the Company or any of its subsidiaries, on the one hand, and the directors, officers, stockholders, customers, suppliers or other affiliates of the Company or any of its subsidiaries, on the other, that is required by the Securities Act to
be described in each of the Registration Statement and the Prospectus and that is not so described in such documents and in the Pricing Disclosure Package.