Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 147

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 147
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 the CE mark to the device, which allows the device to be placed on
the market throughout the EU. If we fail to comply with applicable EU laws and regulations, and corresponding EU member state laws, we
would be unable to affix the CE mark to our products, which would prevent us from selling them within the EU.

The aforementioned EU rules
are generally applicable in the EEA, which consists of the 27 EU member states plus Norway, Liechtenstein and Iceland. Non-compliance with
the above requirements would also prevent us from selling our products in these three countries.

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