(dd) There are no legal or governmental proceedings or contracts or other documents of a
character required to be described in the Registration Statement or the most recent Preliminary Prospectus or, in the case of documents, to be filed as exhibits to the Registration Statement that are not described and filed as required. Neither the
Company nor any of its subsidiaries has knowledge that any other party to any such contract, agreement or arrangement has any intention not to render full performance as contemplated by the terms thereof.
(ee) No relationship, direct or indirect, or related-party transaction exists between or among the Company or any of its subsidiaries, on the
one hand, and the directors, officers, stockholders, customers or suppliers of the Company, on the other hand, that is required to be described in the most recent Preliminary Prospectus which is not so described.
(ff) There is and has been no failure on the part of the Company or any of the Companys directors or officers, in their capacities as
such, to comply in any material respect with any applicable provision of the Sarbanes-Oxley Act, including Section 402 related to loans and Sections 302 and 906 related to certifications.
(gg) Except as described in the most recent Preliminary Prospectus, no labor disturbance by the employees of the Company or its subsidiaries
exists or, to the knowledge of the Company, is imminent that could reasonably be expected to have a Material Adverse Effect.
(hh) Except
as described in the most recent Preliminary Prospectus, the Company and each of its subsidiaries and its and their respective directors and officers and, to the Companys knowledge, its employees and agents (while acting in such capacity) are,
and for the past six years 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 Food, Drug, and Cosmetic
Act (21 U.S.C. §§ 301 et seq.), the Controlled Substances Act (21 U.S.C. §§ 801, et seq.), the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Kickback Enforcement
Act of 1986 (Pub. L. 99-634), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the
administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Physician Self-Referral Law, a/k/a the Stark Law (42 U.S.C. § 1395nn), the exclusion law (42 U.S.C. § 1320a-7), the Program Fraud Civil Remedies Act (31 U.S.C. §§ 3801, et seq.), all criminal laws relating to healthcare fraud and abuse, including, but not limited to, 18 U.S.C. sections 286, 287, 1035, and
1347, 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.), HIPAA, as amended by the Health Information Technology for
Economic and Clinical Health Act (Pub. L. 104-191, Title XIII of the American Recovery and Reinvestment Act of 2009) and any similar state privacy and security laws, the U.S. Food and Drug
Administrations current good manufacturing practice regulations (Title 21 of the Code of Federal Regulations), the FDAs good guidance practices, all laws relating to Federal health care programs (as defined at 42 U.S.C. § 1320a-7b(f)), including, but not limited to, Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), Tricare (10 U.S.C. §§ 1071, et seq.), Veterans Affairs
(38 U.S.C. §§ 101, et seq.), and any State health care program (as defined at 42 U.S.C. 1320a-7(h), the Federal Employees Health Benefits Program (5 U.S.C. §§ 8901, et seq.), the Public
Health Service Act (42 U.S.C. §§ 201, et seq.), each as amended, the regulations promulgated pursuant to such laws, state fee splitting, corporate practice of medicine, and self-referral 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, prescription, dispensing, handling, or distribution of products,
recordkeeping, quality, safety, privacy, security, licensure, accreditation or any other aspect of producing products (collectively, Healthcare Laws). The Company has not received any notification, correspondence, or any
other written or oral communication, including notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, audit, evaluation, arbitration or
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