Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1353

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1353
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 not encounter similar challenges or delays in
the future or that these delays or challenges will not have a material adverse effect on our business, financial condition or results
of operations.

40

We
currently rely on third parties for the manufacture of our product candidates during clinical development, and expect to continue to
rely on third parties for the foreseeable future. This reliance on third parties increases the risk that we will not have sufficient
quantities of our product candidates, or such quantities at an acceptable cost, which could delay, prevent or impair our development
or potential commercialization efforts.

We
do not own or operate manufacturing facilities and have no current plans to develop our own clinical or commercial-scale manufacturing
capabilities. We rely, and expect to continue to rely, on third parties for the manufacture of our product candidates, and related raw
materials for clinical development, as well as for commercial manufacture if any of our product candidates receives regulatory approval.
The facilities used by our third-party manufacturers must be approved for the manufacture of our product candidates by the FDA, EMA,
or any comparable foreign regulatory authority, pursuant to inspections that will be conducted after we submit an NDA or BLA to the FDA,
or submit a comparable marketing application to a foreign regulatory authority. We do not control the manufacturing process of, and are
completely dependent on, third-party manufacturers for compliance with cGMP requirements for manufacture of our product candidates. If
these third-party manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory
requirements of the FDA or any comparable foreign regulatory authority, they will not be able to secure and/or maintain regulatory approval
for the use of their manufacturing facilities.

In
addition, we have no control over the ability of third-party manufacturers to maintain adequate quality control, quality assurance and
qualified personnel. If the FDA, EMA or any comparable foreign regulatory authority does not approve these facilities for the manufacture
our product candidates, or if such authorities withdraw any such approval in the future, we may be required to find alternative manufacturing
facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates,
if approved. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions
being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures
or recalls, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect our financial position.

Our
or