Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 1376

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1A
Chunk 1376
---
 government and may require drug manufacturers to report
    information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures;
    some state laws that require biotechnology companies to report information on the pricing of certain drug products; and some state
    and local laws that require the registration or pharmaceutical sales representatives.

Efforts
to ensure that our current and future business arrangements with third parties will comply with applicable healthcare and privacy laws
and regulations will involve ongoing substantial costs. It is possible that governmental authorities will conclude that our business
practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare
laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that
may apply to us, we may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines,
disgorgement, imprisonment, exclusion from participation in government-funded healthcare programs, such as Medicare and Medicaid, integrity
oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings and the curtailment
or restructuring of our operations. Defending against any such actions can be costly and time-consuming and may require significant financial
and personnel resources.

Therefore,
even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. Further,
if any of the physicians or other healthcare providers or entities with whom we expect to do business are found not to be in compliance
with applicable laws or regulations, they may be subject to significant criminal, civil or administrative sanctions, including exclusions
from government-funded healthcare programs.

Actual
or perceived failures to comply with applicable data protection, privacy and security laws, regulations, standards and other requirements
could adversely affect our business, results of operations, and financial condition.

The
global data protection landscape is rapidly evolving, and we are or may become subject to numerous state, federal and foreign laws, requirements
and regulations governing the collection, use, disclosure, retention, and security of personal information. Implementation standards
and enforcement practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact future laws,
regulations, standards, or perception of their requirements may have on our business. This evolution may create uncertainty in our business,
affect our ability to operate in certain jurisdictions or to collect, store, transfer use and share personal information, necessitate
the acceptance of more onerous obligations in