Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 146

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 146
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 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.

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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