Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 23

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 23
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 clinical superiority to the product with orphan exclusivity or inability to manufacture the product in sufficient quantities. The
designation of such drug or biologic also entitles a party to financial incentives such as opportunities for grant funding towards clinical
trial costs, tax advantages and user-fee waivers. However, competitors, may receive approval of different products for the disease or
condition for which the orphan product has exclusivity or obtain approval for the same product but for a different disease or condition
for which the orphan product has exclusivity. Orphan exclusivity also could block the approval of a competing product for seven years
if a competitor obtains approval of the “same drug,” as defined by the FDA, or if the active ingredient of the product candidate
is determined to be contained within the competitor’s product for the same disease or condition. In addition, if an orphan designated
product receives marketing approval for a disease or condition broader than what is designated, it may not be entitled to orphan exclusivity.

19

Post-Approval
Requirements

Any
products manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including,
among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and
distribution, and advertising and promotion of the product. After approval, most changes to the approved product, such as adding new
indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing user fee requirements,
under which the FDA assesses an annual program fee for each product identified in an approved NDA or BLA. Drug and biologic manufacturers
and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic
unannounced inspections by the FDA and certain state agencies for compliance with cGMPs, which impose certain procedural and documentation
requirements upon us and our third-party manufacturers. Changes to the manufacturing process are strictly regulated, and, depending on
the significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and
correction of any deviations from cGMPs and impose reporting requirements upon us and any third-party manufacturers that we may decide
to use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to maintain
compliance with cGMPs and other aspects of regulatory compliance.

The
FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after