Company: INDP
Filing Date: 2025-02-12
Form Type: S-1
Source: 0001493152-25-006068
Chunk: 102

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-02-12
Form: S-1
Chunk 102
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 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 third-party reimbursement for any product or a decision by a third-party payor not to cover a product could reduce physician usage and patient demand for the product and also have a material adverse effect on sales.

| 73 |

Healthcare Reform

In March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, each as amended, collectively known as the ACA, was enacted, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly affected the pharmaceutical industry. The ACA contains a number of provisions, including those governing enrollment in federal healthcare programs, reimbursement adjustments and changes to fraud and abuse laws. By way of example, the ACA:

| ● | increased                                                                                                                          
 the minimum level of Medicaid rebates payable by manufacturers of brand name drugs from 15.1% to 23.1% of the average manufacturer 
 price;                                                                                                                             |

| ● | required                                                                                                                                 
 collection of rebates for drugs paid by Medicaid managed care organizations;                                                             |
| ● | required                                                                                                                                 
 manufacturers to participate in a coverage gap discount program, under which they must agree to offer 70 percent point-of-sale discounts 
 off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the       
 manufacturers’ outpatient drugs to be covered under Medicare Part D; and                                                                 |
| ● | imposed                                                                                                                                  
 a non-deductible annual fee on pharmaceutical manufacturers or importers who sell “branded prescription drugs” to specified