Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 54

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 54
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aindications, and may include burdensome post-approval study or risk management
requirements. For example, the FDA may require a REMS in order to approve our product candidates, which could entail requirements for
a medication guide, physician training and communication plans or additional elements to ensure safe use, such as restricted distribution
methods, patient registries and other risk minimization tools. In addition, if the FDA or foreign regulatory authorities approve our
product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion,
import, export and recordkeeping for our product candidates will be subject to extensive and ongoing regulatory requirements. These requirements
include submissions of safety and other post-marketing information and reports, registration, as well as on-going compliance with cGMPs
and GCP for any clinical trials that we may conduct. In addition, manufacturers of drug products and their facilities are subject to
continual review and periodic, unannounced inspections by the FDA and other regulatory authorities for compliance with cGMP regulations
and standards. If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated
severity or frequency, or problems with the facilities where the product is manufactured, a regulatory agency may impose restrictions
on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension
of manufacturing. In addition, failure to comply with FDA and other comparable foreign regulatory requirements may subject our company
to administrative or judicially imposed sanctions, including:

    ●
    restrictions
    on the marketing or manufacturing of our products, withdrawal of the product from the market or voluntary or mandatory product recalls;

    ●
    restrictions
    on product distribution or use, or requirements to conduct post-marketing studies or clinical trials;

    ●
    fines,
    restitutions, disgorgement of profits or revenues, warning letters, untitled letters or holds on clinical trials;

    ●
    refusal
    by the FDA to approve 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