Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 64

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 64
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 these rules and regulations are likely.

43

Outside
the United States, international operations are generally subject to extensive governmental price controls and other market regulations,
and we believe the increasing emphasis on cost-containment initiatives in Europe and other countries has and will continue to put pressure
on the pricing and usage of our products candidates, if approved in these jurisdictions. In many countries, the prices of medical products
are subject to varying price control mechanisms as part of national health systems. Other countries allow companies to fix their own
prices for medical products but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation
could restrict the amount that we are able to charge for our products. Accordingly, in markets outside the United States, if any, the
reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable
revenue and profits.

Moreover,
increasing efforts by governmental and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause
such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover
or provide adequate payment for our products. We expect to experience pricing pressures in connection with the sale of any of our products
due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes.
The downward pressure on healthcare costs in general, and prescription drugs, surgical procedures and other treatments in particular,
has become very intense. As a result, increasingly high barriers are being erected to the entry of new products.

Recently
enacted legislation, future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing
approval for and commercialize Decoy20 and any future product candidates and may affect the prices we may set.

In
the United States and some foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative and
regulatory changes to the healthcare system, including cost-containment measures that may reduce or limit coverage and reimbursement
for newly approved drugs and affect our ability to profitably sell any product candidates for which we obtain marketing approval. In
particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare
costs and improve the quality of healthcare.

By
way of example, in March 2010, the ACA was enacted in the United States. The ACA established an annual, nondeductible fee