Company: RGNT
Filing Date: 2025-05-19
Form Type: F-1/A
Source: 0001213900-25-045479
Chunk: 148

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-19
Form: F-1/A
Chunk 148
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 may apply more broadly to items or services covered by any third-party payor, including commercial insurers
and self-pay patients.

<div align='center'>86</div>

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 claim to the federal government. As a result of a modification made by the Fraud Enforcement and Recovery
Act of 2009, a claim includes “any request or demand” for money or property presented to the U.S. government. In addition,
a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent
claim for purposes of the federal civil False Claims Act. Private parties may initiate “qui tam” whistleblower lawsuits against
any person or entity under the federal civil False Claims Act in the name of the government and share in the proceeds of the lawsuit.

HIPAA also created additional
federal criminal statutes that prohibit among other actions, knowingly and willfully executing, or attempting to execute, a scheme to
defraud any health care benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a health
care benefit program, willfully obstructing a criminal investigation of a health care offense, and knowingly and willfully falsifying,
concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery
of or payment for health care benefits, items or services. Similar to the federal Anti-Kickback Statute, 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. Also, many states have
similar fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and other state programs, or,
in several states, apply regardless of the payor.

Additionally, there has been
a recent trend of increased foreign, federal, and state regulation of payments and transfers of value provided to health care professionals
or entities. The federal Physician Payments Sunshine Act imposes annual reporting requirements on certain drug, biologics, medical supplies
and device manufacturers for which payment is available under Medicare, Medicaid or CHIP for payments and other transfers of value provided
by them, directly or indirectly, to