Health Care Laws means (i) the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. §§ 301 et Seq.), and the regulations promulgated thereunder, (ii) the Public Health Service Act (42 U.S.C. §§ 201 et seq.) and the regulations promulgated thereunder, (iii) all federal and state fraud and
abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. §1320a7b(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)), Sections 1320a-7 and 1320a-7a of Title 42 of the United States Code, all criminal laws relating to health care
fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 and 1349, the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), and the regulations promulgated pursuant to such
statutes, (iv) the Health Insurance Portability and Accountability Act of 1996 (18 U.S.C. §§669, 1035, 1347 and 1518; 42 U.S.C. §1320d et seq.) and the regulations promulgated thereunder, (v) Titles XVIII (42 U.S.C.
§1395 et seq.) and XIX (42 U.S.C. §1396 et seq.) of the Social Security Act and the regulations promulgated thereunder, (vi) the Patient Protection and Affordable Care Act, (vii) all applicable statutes, rules or regulations
relating to the ownership, testing, development, manufacture, quality, safety, accreditation, packaging, use, distribution, labeling, promotion, sale, offer for sale, import, export or disposal of any product manufactured or distributed by the
Company, each of (i) through (vi) as may be amended from time to time.
Intellectual Property shall have the
meaning ascribed to such term in Section 3.1(p).
Investor has the meaning set forth in the Recitals.
Investor Party shall have the meaning ascribed to such term in Section 4.6.
Liens means a lien, charge, pledge, security interest, encumbrance, right of first refusal, preemptive right or other
restriction.
Lock-Up Agreement means the
Lock-Up Agreement, dated as of the date hereof, by and among the Company and the directors and officers of the Company, in the form reasonably acceptable to the Placement Agent.
Major Stockholders means Investors who (i) are (a) an accredited investor (as defined in Rule 501 of
Regulation D under the Securities Act) or (b) a qualified institutional buyer (as defined in Rule 144A under the Securities Act), (ii) hold a Prior Warrant and (iii) pursuant to this Agreement, invest in an amount equal to at
least 40% of such Investors prior investment pursuant to that certain Securities Purchase Agreement, dated December 11, 2023, by and among the Company and the investors identified therein.
Material Adverse Effect shall have the meaning ascribed to such term in Section 3.1(b).
Material Contract means any contract, instrument or other agreement to which the Company is a party or by which it is bound
which is material to the business of the Company, including those that have been filed as an exhibit to the SEC Reports pursuant to Item 601(b)(10) of Regulation S-K.
4