Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 24

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 24
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 the product
reaches the market. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity
or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved
labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition
of distribution restrictions or other restrictions under a REMS program. Other potential consequences include, among other things:

    ●
    restrictions on the marketing
    or manufacturing of a product, complete withdrawal of the product from the market or product recalls;

    ●
    fines, warning letters
    or holds on post-approval clinical studies;

    ●
    refusal of the FDA to approve
    pending applications or supplements to approved applications, or suspension or revocation of existing product approvals;

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

    ●
    consent decrees, corporate
    integrity agreements, debarment or exclusion from federal healthcare programs;

    ●
    mandated modification of
    promotional materials and labeling and the issuance of corrective information;

    ●
    the issuance of safety
    alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information
    about the product; or

    ●
    injunctions or the imposition
    of civil or criminal penalties.

The
FDA closely regulates the marketing, labeling, advertising and promotion of drug products and biologics. A company can make only those
claims relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the
approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. Failure
to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential
civil and criminal penalties. Physicians may prescribe legally available products for uses that are not described in the product’s
labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties.
Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate
the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the
subject of off-label use of their products.

20

Drug
Product Marketing Exclusivity

Market