Company: RGNT
Filing Date: 2025-03-11
Form Type: F-1
Source: 0001213900-25-022350
Chunk: 145

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-03-11
Form: F-1
Chunk 145
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 Iceland. Non-compliance with
the above requirements would also prevent us from selling our products in these three countries.

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Federal, State and Foreign Fraud and Abuse and Physician Payment Transparency Laws

In addition to FDA restrictions
on marketing and promotion of drugs and devices, other federal and state laws restrict our business practices. These laws include, without
limitation, foreign, federal, and state anti-kickback and false claims laws, as well as transparency laws regarding payments or other
items of value provided to health care providers.

The federal Anti-Kickback
Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving any remuneration (including
any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind to induce or in return for purchasing,
leasing, ordering or arranging for or recommending the purchase, lease or order of any good, facility, item or service reimbursable,
in whole or in part, under Medicare, Medicaid or other federal health care programs. Although there are a number of statutory exceptions
and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly. Failure
to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per
se illegal under the federal Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis
based on a cumulative review of all its facts and circumstances. Several courts have interpreted the statute’s intent requirement
to mean that if any one purpose of an arrangement involving remuneration is to induce referrals of federal health care covered business,
the federal Anti-Kickback Statute has been violated. In addition, a person or entity does not need to have actual knowledge of the statute
or specific intent to violate it in order to have committed a violation. The majority of states also have anti-kickback laws which establish
similar prohibitions and in some cases may apply more broadly to items or services covered by any third-party payor, including commercial
insurers and self-pay patients.

The federal civil False Claims
Act prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, a false or fraudulent
claim for payment or approval to the federal government or knowingly making, using or causing to be made or used a false record or statement
material to a false or fraudulent