Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 57

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 57
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 in the conduct and
timing of these trials and subsequent collection and analysis of data. Though we expect to carefully manage our relationships with such
CROs, investigators and other third parties, there can be no assurance that we will not encounter challenges or delays in the future,
or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects. Further,
while we have and will have agreements governing the activities of our third-party contractors, we have limited influence over their
actual performance. Nevertheless, we maintain responsibility for ensuring that each of our clinical trials and preclinical studies is
conducted in accordance with the applicable protocol, legal, regulatory, and scientific standards and our reliance on these third parties
does not relieve us of our regulatory responsibilities. We and our CROs and other vendors are required to comply with requirements for
cGMP, or similar foreign requirements, GCP, and good laboratory practice (GLP), which are a collection of laws and regulations enforced
by the FDA, the EMA and comparable foreign authorities for all of our product candidates in clinical development. Regulatory authorities
enforce these regulations through periodic inspections of preclinical study and clinical trial sponsors, principal investigators, preclinical
study and clinical trial sites, and other contractors. If we or any of our CROs or vendors fail to comply with applicable regulations,
the data generated in our preclinical studies and clinical trials may be deemed unreliable, and the FDA, the EMA or comparable foreign
authorities may require us to perform additional preclinical studies and clinical trials before approving our marketing applications.
We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical
trials comply with GCP regulations. In addition, our clinical trials must be conducted with products produced consistent with cGMP regulations,
or similar foreign requirements. Our failure to comply with these regulations may require it to repeat clinical trials, which would delay
the development and regulatory approval processes.

We
may not be able to enter into arrangements with CROs on commercially reasonable terms, or at all. In addition, our CROs will not be our
employees, and except for remedies available to us under our agreements with such CROs, we will not be able to control whether or not
they devote sufficient time and resources to our ongoing preclinical and clinical programs. If CROs do not successfully carry out their
contractual duties or obligations or meet expected deadlines, if they need to be