Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 145

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 145
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 any parts which relate to sterility, metrology or reuse aspects), a conformity assessment procedure
requires the intervention of an organization accredited or designated by a member state of the EU to conduct conformity assessments,
or a notified body. Depending on the relevant conformity assessment procedure, the notified body would typically audit and examine the
technical file and the quality system for the manufacture, design and final inspection of our devices. If satisfied that the relevant
product conforms to the relevant essential requirements, the notified body issues a certificate of conformity, which the manufacturer
uses as a basis for its own declaration of conformity. The manufacturer may then apply 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