Company: SXTPW
Filing Date: 2025-03-27
Form Type: S-1/A
Source: 0001013762-25-003353
Chunk: 168

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: S-1/A
Chunk 168
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, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross-border imports from low-priced markets exert competitive pressure that may reduce pricing within a country. Any country that has price controls or reimbursement limitations for drug products may not allow favorable reimbursement and pricing arrangements. Healthcare Law and Regulation Healthcare providers and third-party payors play a primary role in the recommendation and prescription of drug products that are granted regulatory approval. Arrangements with providers, consultants, third-party payors and customers are subject to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain our business and/or financial arrangements. Such restrictions under applicable federal and state healthcare laws and regulations, include the following:

| ● | the federal Anti-Kickback                                                                                                          
 Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or 
 providing remuneration (including any kickback, bribe or rebate), directly or indirectly, in cash or in kind, to induce or reward  
 either the referral of an individual for, or the purchase, lease or order of, any good or service, for which payment may be made,  
 in whole or in part, under a federal healthcare program such as Medicare and Medicaid;                                             |

| ● | the federal civil and criminal                                                                                                      
 false claims laws, including the civil False Claims Act, and civil monetary penalties laws, which prohibit individuals or entities  
 from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are  
 false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; |

| ● | the federal Health Insurance                                                                                                            
 Portability and Accountability Act of 1996, which created additional federal criminal laws that prohibit, among other things, knowingly 
 and willingly executing, or attempting to execute, a scheme or making false statements in connection with the delivery of or payment    
 for health care benefits, items, or services;                                                                                           |

| ● | HIPAA, as amended by the                                                                                                                
 Health Information Technology for Economic and Clinical Health Act and its implementing regulations, which also imposes obligations,    
 including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable 
 health information on covered entities and their business associates that associates that perform certain functions or activities       
 that involve the use or disclosure of protected health information on their behalf;                                                     |

105

| ● | the federal transparency