Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1354

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1354
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 a third party’s failure to execute on our manufacturing requirements on commercially reasonable terms and in compliance with
cGMP or other regulatory requirements could adversely affect our business in a number of ways, including:

    ●
    an
    inability to initiate or complete clinical trials of our product candidates in a timely manner;

    ●
    delay
    in submitting regulatory applications, or receiving regulatory approvals, for our product candidates;

    ●
    subjecting
    third-party manufacturing facilities to additional inspections by regulatory authorities;

    ●
    requirements
    to cease development or to recall batches of our product candidates; and

    ●
    in
    the event of approval to market and commercialize any product candidate, an inability to meet commercial demands.

In
addition, we do not have any long-term commitments or supply agreements with any third-party manufacturers. We may be unable to establish
any long-term supply agreements with third-party manufacturers or to do so on acceptable terms, which increases the risk of failing to
timely obtain sufficient quantities of our product candidates or such quantities at an acceptable cost. Even if we are able to establish
agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

    ●
    failure
    of third-party manufacturers to comply with regulatory requirements and maintain quality assurance;

    ●
    breach
    of the manufacturing agreement by the third party;

    ●
    failure
    to manufacture our product candidates according to our specifications;

    ●
    failure
    to manufacture our product according to our schedule or at all;

    ●
    misappropriation
    of our proprietary information, including our trade secrets and know-how; and

    ●
    termination
    or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.

41

Any
performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval, and any
related remedial measures may be costly or time consuming to implement. We do not currently have arrangements in place for redundant
supply or a second source for all required raw materials used in the manufacture of our product candidates. If our existing or future
third-party manufacturers cannot perform as agreed, we may be required to replace such manufacturers and we may be unable to replace
them on a timely basis or at all, which would have a material adverse impact on our financial position.

Any
clinical supply or collaboration arrangement that we may enter into in the future may