Company: INDP
Filing Date: 2025-03-13
Form Type: 10-K
Source: 0001493152-25-010136
Chunk: 27

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-03-13
Form: 10-K
Item: Item 1
Chunk 27
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biological product can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted, adds six months
to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of existing exclusivity protection
or patent term, may be granted based on the voluntary completion of a pediatric study in accordance with an FDA-issued “Written
Request” for such a study.

Other
Healthcare Laws

Pharmaceutical
companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states
and foreign jurisdictions in which they conduct their business and may constrain the financial arrangements and relationships through
which we research as well as sell, market and distribute any products for which we obtain marketing approval. Such laws include, without
limitation, federal and state anti-kickback, fraud and abuse, false claims, data privacy and security and physician and other healthcare
provider transparency laws and regulations. If our operations are found to be in violation of any of such laws or any other governmental
regulations that apply, they may be subject to penalties, including, without limitation, administrative, civil and criminal penalties,
damages, fines, disgorgement, the curtailment or restructuring of operations, integrity oversight and reporting obligations, exclusion
from participation in federal and state healthcare programs and imprisonment.

Coverage
and Reimbursement

Sales
of any product depend, in part, on the extent to which such product will be covered by third-party payors, such as federal, state, and
foreign government healthcare programs, commercial insurance and managed healthcare organizations, and the level of reimbursement for
such product by third-party payors. Decisions regarding the extent of coverage and amount of reimbursement to be provided are made on
a plan-by-plan basis. 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 obtained. These third-party payors are increasingly reducing reimbursements for medical products, drugs and services. In addition,
the U.S. government, state legislatures and foreign governments have continued implementing cost-containment programs, including price
controls, restrictions on coverage and reimbursement and requirements for substitution of generic products. Adoption of price controls
and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could
further limit sales of any product. Decreases in