Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 66

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 66
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 include the
establishment of a drug price negotiation program within the U.S. Department of Health and Human Services, or HHS (beginning in 2026)
that requires manufacturers to charge a negotiated “maximum fair price” for certain selected drugs or pay an excise tax for
noncompliance, the establishment of rebate payment requirements on manufacturers under Medicare Parts B and D to penalize price increases
that outpace inflation (first due in 2023), and a redesign of the Part D benefit, as part of which manufacturers are required to provide
discounts on Part D drugs (beginning in 2025). The IRA permits the HHS Secretary to implement many of these provisions through guidance,
as opposed to regulation, for the initial years. On August 29, 2023, HHS announced the list of the first ten drug that will be subject
to price negotiations, although the drug price negotiation program is currently subject to legal challenges. For that and other reasons,
it is currently unclear how the IRA will be effectuated. Additional drug pricing proposals could appear in future legislation.

At
the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and
biological product pricing, including price or reimbursement constraints, discounts, restrictions on certain product access and marketing
cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, results of operations,
financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding
procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare
programs. This could reduce the ultimate demand for Decoy20 and any future product candidates, if approved, or put pressure on our product
pricing, which could negatively affect our business, results of operations, financial condition and prospects.

We
expect that these new laws and other healthcare reform measures that may be adopted in the future may result in additional reductions
in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure
on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may
result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms
may prevent us from being able to generate revenue, attain profitability or commercialize Decoy20 and any future product