(ii) all applicable federal, state, local and foreign health care laws, including,
without limitation, the U.S. Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. Section 3729 et seq.), all applicable federal,
state, local and foreign criminal laws relating to health care fraud and abuse, including but not limited to the U.S. False Statements Law (42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, and the health care 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, the statutes, regulations and directives of applicable government
funded or sponsored healthcare programs, and the regulations promulgated pursuant to such statutes;
(iii) the Standards for Privacy
of Individually Identifiable Health Information, the Security Standards, and the Standards for Electronic Transactions and Code Sets promulgated under HIPAA, the Health Information Technology for Economic and Clinical Health Act (42 U.S.C.
Section 17921 et seq.), and the regulations promulgated thereunder and any applicable state or non-U.S. counterpart thereof or any other applicable law or regulation the purpose of which is to protect the privacy of individuals or prescribers;
(iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of
2010, and the regulations promulgated thereunder;
(v) licensure, quality, safety and accreditation requirements under applicable
federal, state, local or foreign laws or regulatory bodies; and
(vi) all other local, state, federal, national, supranational and
foreign laws, relating to the regulation of the Company and the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any
product under development, manufactured or distributed by the Company; (clauses (i) through (viii), collectively, Health Care Laws).
(t) Intellectual Property. (i) To its knowledge, the Company and its Subsidiaries own, have a license to use, or otherwise
possess sufficient rights to all patents, inventions, copyrights, know how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information, systems or procedures), trademarks, service marks and trade names
and all other worldwide intellectual property and proprietary rights (including all registrations and applications for registration of, and all goodwill associated with, any of the foregoing) (collectively, Intellectual Property
Rights) used in or that would reasonably be expected to be material to the conduct of their respective businesses as now conducted by them, and as currently proposed to be conducted in the Registration Statement or the Prospectus;
(ii) other than as would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect on the Company and its Subsidiaries, taken as a whole, or as described in the Registration Statement or the Prospectus,
(A) the Intellectual Property Rights owned, and to the Companys knowledge, licensed by the Company and its Subsidiaries are valid, subsisting and enforceable, and (B) there is no pending or, to the Companys knowledge,
threatened action, suit, proceeding or claim by others challenging the validity, scope or enforceability of or any rights of the Company or any of its Subsidiaries in, any such Intellectual Property Rights; (iii) other than as described in the
Registration Statement or the Prospectus, neither the Company nor any of its Subsidiaries has received any notice alleging any infringement, misappropriation or other violation of Intellectual Property Rights of any third party which, singly or in
the aggregate, if the subject of an unfavorable decision, ruling or finding, would have a Material Adverse Effect on the Company and its Subsidiaries, taken as a whole; (iv) to the Companys knowledge, no Person (as defined in
Section 6(ww)) is infringing, misappropriating or otherwise violating, or has infringed, misappropriated or otherwise violated, any Intellectual Property Rights owned or licensed by the Company or any of its Subsidiaries; (v) other than as
would not, singly or in the aggregate, reasonably be expected to have a Material Adverse Effect on the Company and its Subsidiaries, taken as a whole, or as described in the Registration Statement or the Prospectus, to the Companys knowledge,
neither the Company nor any of its Subsidiaries infringes, misappropriates or otherwise violates, or has infringed, misappropriated or otherwise violated, any Intellectual Property Rights of any Person, and the conduct of each of the respective
businesses of, the Company and its Subsidiaries as described in the Registration Statement or the Prospectus does not infringe, misappropriate, or otherwise violate any Intellectual Property Rights of any Person; (vi) to the Companys
knowledge, the Company and its Subsidiaries have taken reasonable steps necessary to secure its respective interests in Intellectual Property Rights, by the execution of appropriate confidentiality agreements and invention assignment agreements,
from the Companys and its Subsidiaries employees or contractors engaged in the development of Intellectual Property Rights on behalf of the Company or any of its Subsidiaries and to the Companys knowledge no such agreement has been
breached or violated; and (vii) the Company and its Subsidiaries use, and have used, commercially reasonable efforts to appropriately maintain the confidentiality of all information intended to be maintained as a trade secret.