Company: SHPH
Filing Date: 2025-02-13
Form Type: S-1
Source: 0001493152-25-006202
Chunk: 54

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-13
Form: S-1
Chunk 54
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 false or fraudulent, and           
 which may apply to us by virtue of statements and representations made to customers or third parties;                                      |
| ● | the                                                                                                                                        
 U.S. federal Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical       
 Health (HITECH) Act, which prohibit executing a scheme to defraud healthcare programs, impose requirements relating to the privacy,        
 security, and transmission of individually identifiable health information, and require notification to affected individuals and           
 regulatory authorities of certain breaches of security of individually identifiable health information;                                    |
| ● | the                                                                                                                                        
 federal Open Payments regulations under the National Physician Payment Transparency Program have been issued under the Patient Protection  
 and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, and will require that manufacturers 
 of pharmaceutical and biological drugs covered by Medicare, Medicaid, and Children’s Health Insurance Programs report all consulting       
 fees, travel reimbursements, research grants, and other payments or gifts with values over $10 made to physicians and teaching hospitals;  
 and                                                                                                                                        |
| ● | state                                                                                                                                      
 laws comparable to each of the above federal laws, such as, for example, anti-kickback and false claims laws applicable to commercial      
 insurers and other non-federal payors, requirements for mandatory corporate regulatory compliance programs, and laws relating to           
 patient data privacy and security.                                                                                                         |

| 33 |

If our operations are found to be in violation of any such requirements, we may be subject to penalties, including civil or criminal penalties, monetary damages, the curtailment or restructuring of our operations, loss of eligibility to obtain approvals from the FDA, or exclusion from participation in government contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid, any of which could adversely our financial results. Although effective compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, these risks cannot be entirely eliminated. Any action against us for an alleged or suspected violation could cause us to incur significant legal expenses and could divert our management’s attention from the operation of our business, even if our defense is successful. In addition, achieving and sustaining compliance with applicable laws and regulations may be costly to us in terms of money, time, and resources.

If we or our collaborators, manufacturers or service providers fail to comply with applicable federal, state, or foreign laws or regulations, we could be subject to enforcement actions, which could affect our ability to develop, market and sell our products successfully and could harm our reputation and lead to