Company: SXTPW
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-014334
Chunk: 187

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-02-14
Form: S-1
Chunk 187
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 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;                                                     |

111

| ● | the federal transparency                                                                                                            
 requirements known as the federal Physician Payments Sunshine Act, under the Patient Protection and Affordable Care Act, as amended 
 by the Health Care Education Reconciliation Act (collectively the “ACA”), which requires certain manufacturers of drugs,            
 devices, biologics and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance 
 Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services (“CMS”),                      
 within the U.S. Department of Health and Human Services, information related to payments and other transfers of value to physicians 
 and teaching hospitals and information regarding ownership and investment interests held by physicians and their immediate family   
 members; and                                                                                                                        |

| ● | analogous state and foreign                                                                                                       
 laws and regulations, such as state anti-kickback and false claims laws, which may apply to healthcare items or services that are 
 reimbursed by non-governmental third-party payors, including private insurers.                                                    |

Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other health care providers or marketing expenditures. State and foreign laws also govern the privacy and security of health information in some circumstances, many of