Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 146

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 146
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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 physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain
other health care providers beginning in 2022, and teaching hospitals, as well as ownership and investment interests held by physicians
and their immediate family members. Beginning in 2022, such obligations will include payments and other transfers of value provided in
the previous year to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiologist
assistants and certified nurse midwives. Certain foreign countries and U.S. states also mandate implementation of commercial compliance
programs, impose restrictions on device manufacturer marketing practices and require tracking and reporting of gifts, compensation and
other remuneration to health care professionals and entities.

Penalties for violation of
any of the health care laws described above or any other governmental regulations that apply to us include, without limitation, civil,
criminal and/or administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government programs,
such as Medicare and Medicaid, injunctions, refusal to allow us to enter into government