Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1375

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1375
---
, using or causing to be made or used, a false record or statement material to a false
    or fraudulent claim, or from knowingly making or causing to be made a false statement to avoid, decrease or conceal an obligation
    to pay money to the federal government. In addition, the government may assert that 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 civil False Claims
    Act;

    ●
    the
    federal Health Insurance Portability and Accountability Act of 1996 (HIPAA), which imposes criminal and civil liability for, among
    other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or
    knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection
    with the delivery of, or payment for, healthcare 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;

53

    ●
    the
    federal Physician Payments Sunshine Act, which requires certain manufacturers of drugs, devices, biologics and medical supplies for
    which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to
    report annually to the Centers for Medicare & Medicaid Services (CMS), information related to payments and other “transfers
    of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician
    practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiology
    assistants and certified nurse-midwives), and teaching hospitals and other healthcare providers, as well as ownership and investment
    interests held by such healthcare professionals and their immediate family members; and

    ●
    analogous
    state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing
    arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private
    insurers; some state laws require biotechnology companies to comply with the biotechnology industry’s voluntary compliance
    guidelines and the relevant compliance guidance promulgated by the federal