Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 236

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 236
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 divisions of the U. S. Department of Health and Human Services (e. g., the Office of
Inspector General), the U. S. Department of Justice, state Attorneys General, and other state and local government agencies. For
example, sales, marketing and scientific/educational grant programs must comply with the fraud and abuse provisions applicable to pharmaceutical
manufacturers, including the federal “ Anti-Kickback Statute”, the Civil Monetary Penalty Statute, the Stark Law, the federal
False Claims Act, as amended, state and federal “ Physician Payment Sunshine Act” laws and regulations, the privacy regulations
promulgated under the Health Insurance Portability and Accountability Act, or HIPAA, and similar state laws. Pricing and rebate programs
must comply with the Medicaid Drug Rebate Program requirements of the Omnibus Budget Reconciliation Act of 1990, as amended,
and the Veterans Health Care Act of 1992, as amended. If products are made available to authorized users of the Federal Supply
Schedule of the General Services Administration, additional laws and requirements apply. All of these activities are also potentially
subject to federal and state consumer protection and unfair competition laws. Some of these health care laws include:

The Anti- Kickback
Statute makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its behalf) to knowingly and
willfully solicit, receive, offer, or pay any remuneration that is intended to induce the referral of business, including the purchase,
order, or prescription of a particular drug, for which payment may be made under a federal healthcare program, such as Medicare or Medicaid.

The federal False
Claims Act prohibits anyone from knowingly presenting, conspiring to present, making a false statement in order to present, or causing
to be presented, for payment to federal programs (including Medicare and Medicaid) claims for items or services, including drugs, that
are false or fraudulent, claims for items or services not provided as claimed, or claims for medically unnecessary items or services.
This law also prohibits anyone from knowingly underpaying an obligation owed to a federal program. Increasingly, U. S. federal agencies
are requiring nonmonetary remedial measures, such as corporate integrity agreements in False Claims Act settlements. The U. S. Department
of Justice announced in 2016 its intent to follow the “ Yates Memo,” taking a far more aggressive approach in pursuing individuals
as False Claims Act defendants in addition to the corporations.

The Physician Payment
Sunshine Act