Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 63

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 63
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 may be decreased or eliminated in the future.

Third-party
payors increasingly are challenging prices charged for biopharmaceutical products and services, and many third-party payors may refuse
to provide coverage and reimbursement for particular drugs when an equivalent generic drug or a less expensive therapy is available.
It is possible that a third-party payor may consider our products as substitutable and only offer to reimburse patients for the less
expensive product. Even if we are successful in demonstrating improved efficacy or improved convenience of administration with our products,
pricing of existing drugs may limit the amount we will be able to charge for our products. These payors may deny or revoke the reimbursement
status of a given product or establish prices for new or existing marketed products at levels that are too low to enable us to realize
an appropriate return on our investment in product development. If reimbursement is not available or is available only at limited levels,
we may not be able to successfully commercialize our products and may not be able to obtain a satisfactory financial return on products
that we may develop.

There
is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products. In the United States,
third-party payors, including private and governmental payors, such as the Medicare and Medicaid programs, play an important role in
determining the extent to which new drugs will be covered. Some third-party payors may require pre-approval of coverage for new or innovative
devices or drug therapies before they will reimburse healthcare providers who use such therapies. It is difficult to predict at this
time what third-party payors will decide with respect to the coverage and reimbursement for Decoy20 and any future product candidates.

Obtaining
and maintaining reimbursement status is time-consuming, costly and uncertain. The Medicare and Medicaid programs increasingly are used
as models for how private payors and other governmental payors develop their coverage and reimbursement policies for drugs. However,
no uniform policy for coverage and reimbursement for products exists among third-party payors in the United States. Therefore, coverage
and reimbursement for products can differ significantly from payor to payor. As a result, the coverage determination process is often
a time consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each
payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.
Furthermore, rules and regulations regarding reimbursement change frequently and, in some cases, at short notice, and we believe that
changes in