Company: INDP
Filing Date: 2025-02-12
Form Type: S-1
Source: 0001493152-25-006068
Chunk: 49

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-02-12
Form: S-1
Chunk 49
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 medical supplies for      
 which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to              
 report annually to the Centers for Medicare & Medicaid Services (CMS), information related to payments and other “transfers              
 of value” made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician  
 practitioners (physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiology       
 assistants and certified nurse-midwives), and teaching hospitals and other healthcare providers, as well as ownership and investment     
 interests held by such healthcare professionals and their immediate family members; and                                                  |
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 state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing         
 arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private      
 insurers; some state laws require biotechnology companies to comply with the biotechnology industry’s voluntary compliance               
 guidelines and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report       
 information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures;     
 some state laws that require biotechnology companies to report information on the pricing of certain drug products; and some state       
 and local laws that require the registration or pharmaceutical sales representatives.                                                    |

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Efforts to ensure that our current and future business arrangements with third parties will comply with applicable healthcare and privacy laws and regulations will involve ongoing substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government-funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings and the curtailment or restructuring of our operations. Defending against any such actions can be costly and time-consuming and may require significant financial and personnel resources.

Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. Further, if