Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 80

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 80
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 in defending
against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

Risks
Related to Healthcare Laws and Other Legal Compliance Matters

We
are subject to various U.S. federal, state and foreign healthcare laws and regulations, which could increase compliance costs, and our
failure to comply with these laws and regulations could harm our results of operations and financial condition.

Our
business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors,
patient organizations and customers expose us to broadly applicable foreign, federal and state fraud and abuse and other healthcare laws
and regulations. These laws may constrain the business or financial arrangements and relationships through which we conduct our operations,
including how we research, market, sell and distribute any products for which we obtain marketing approval. Such laws include:

    ●
    the
    federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting,
    offering, receiving or providing any remuneration (including any kickback, bribe or certain rebates), directly or indirectly, overtly
    or covertly, in cash or in kind, in return for, either the referral of an individual or the purchase, lease, or order, or arranging
    for or recommending the purchase, lease, or order of any good, facility, item or service, for which payment may be made, in whole
    or in part, under a federal healthcare program such as Medicare and Medicaid. A person or entity does not need to have actual knowledge
    of the federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation;

    ●
    the
    federal false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit, among other things,
    individuals or entities from knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval
    that are false or fraudulent, knowingly making, 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