Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1349

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1349
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 pending applications or supplements to approved applications submitted by us or suspension or revocation of
    approvals;

    ●
    product
    seizure or detention, or refusal to permit the import or export of our products; and

    ●
    injunctions
    or the imposition of civil or criminal penalties.

The
occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenue
and could require us to expend significant time and resources in response and could generate negative publicity.

The
FDA’s and other regulatory authorities’ policies may change and additional government regulations may be promulgated that
could prevent, limit or delay marketing authorization of any product candidates we develop. We also cannot predict the likelihood, nature
or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad.
If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not
able to maintain regulatory compliance, we may be subject to enforcement action and we may not achieve or sustain profitability.

The
FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

The
FDA strictly regulates marketing, labeling, advertising and promotion of prescription drugs. These regulations include standards and
restrictions for direct-to-consumer advertising, industry-sponsored scientific and educational activities, promotional activities involving
the internet and off-label promotion. Any regulatory approval that the FDA grants is limited to those specific diseases and indications
for which a product is deemed to be safe and effective by FDA. While physicians in the United States may choose, and are generally permitted,
to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical
trials and approved by the regulatory authorities, our ability to promote any products will be narrowly limited to those indications
that are specifically approved by the FDA.

38

If
we are found to have promoted such off-label uses, we may become subject to significant liability. The U.S. federal government has levied
large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from
engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under
which specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion of any product candidates,
if approved, we could become subject to significant liability, which would