Company: PTHS
Filing Date: 2025-08-28
Form Type: S-3
Source: 0001753926-25-001403
Chunk: 53

Company: Pelthos Therapeutics Inc.
Filing Date: 2025-08-28
Form: S-3
Chunk 53
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, physicians and others will play a primary role in the recommendation and prescription of ZELSUVMI, and other product candidates, if approved. Our arrangements and interactions with healthcare professionals, third-party payors, patients and others will expose us to broadly applicable fraud and abuse, antikickback, false claims and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell, and distribute ZELSUVMI and other product candidates, if we obtain regulatory approval. The U.S. federal healthcare laws and regulations that may affect our ability to operate include, but are not limited to:

| ● | the                                                                                                                                      
 federal healthcare Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully         
 soliciting, offering, paying, or receiving remuneration, (anything of value), directly or indirectly, in cash or in kind, to induce      
 or reward either the referral of an individual for, or the purchase, lease order or arranging for or recommending the purchase,          
 lease or order of any good or service for which payment may be made, in whole or in part, by federal healthcare programs such            
 as Medicare and Medicaid. This statute has been interpreted to apply to arrangements between pharmaceutical companies on one hand        
 and prescribers, purchasers, formulary managers, and patients on the other. Liability under the Anti-Kickback Statute may be established 
 without proving actual knowledge of the statute or specific intent to violate it;                                                        |

| ● | the                                                                                                                                   
 federal civil FCA, which prohibits individuals or entities from, among other things, knowingly presenting, or causing to be presented 
 a false or fraudulent claim for payment of government funds, or knowingly making, using or causing to made or used a false record     
 or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding,   
 decreasing or concealing an obligation to pay money to the federal government. Actions under the FCA may be brought by the Attorney   
 General or as a qui tam action by a private individual in the name of the government. Such private individuals may share in amounts   
 paid by the entity to the government in recovery or settlement. The government may assert that a claim including items or services    
 resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal   
 civil FCA;                                                                                                                            |

| ● | the                                                                                                                                   
 federal civil monetary penalties laws, which impose civil fines