Company: PTHS
Filing Date: 2025-08-28
Form Type: S-3
Source: 0001753926-25-001403
Chunk: 54

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-28
Form: S-3
Chunk 54
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 for, among other things, the offering or transfer or remuneration     
 to a Medicare or state healthcare program beneficiary, if the person knows or should know it is likely to influence the beneficiary’s 
 selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state health care program,    
 unless an exception applies;                                                                                                          |

| ● | the                                                                                                                                 
 federal HIPAA imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program, including      
 private third-party payors, or for knowingly and willfully falsifying, concealing or covering up a material fact or making any      
 materially false, fictitious or fraudulent statement or representation, or making or using any false writing or document knowing    
 the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment 
 for healthcare benefits, items or services. Similar to the federal healthcare Anti-Kickback Statute, a person or entity does not    
 need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;                        |

| ● | the                                                                                                                                  
 federal Physician Payments Sunshine Act, implemented as the Open Payments Program, requires certain manufacturers of drugs, devices, 
 biologics and medical supplies to report payments and other transfers of value to physicians for which payment is available under    
 Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to CMS information        
 related 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, as well as ownership and investment interests held by physicians    
 and their immediate family members. Manufacturers must submit reports on or before the 90th day of each calendar year disclosing     
 reportable payments made in the previous calendar year;                                                                              |

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| ● | analogous                                                                                                                               
 state laws and regulations, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed          
 under Medicaid and other state programs or, in several states, regardless of the payer, including private insurers. Some state          
 laws require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products and         
 to report gifts and payments to individual health care providers in those states. Some of these states