Company: SXTPW
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-014334
Chunk: 65

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-02-14
Form: S-1
Chunk 65
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 health care programs. Many states have similar laws applicable to items or services reimbursed by commercial insurers. Violations of these laws are punishable by criminal and civil sanctions, including, in some instances, imprisonment and exclusion from participation in federal and state health care programs, including the Medicare, Medicaid and Veterans Affairs healthcare programs. Because of the far-reaching nature of these laws, we may be required to discontinue one or more of our practices to be in compliance with these laws. Healthcare fraud and abuse regulations are complex, and even minor irregularities can potentially give rise to claims that a statute or prohibition has been violated. Any violations of these laws, or any action against us for violations of these laws, even if we successfully defend against it, could have a material adverse effect on our business, financial condition and results of operations. If we, our collaborators or our third-party manufacturers fail to comply with applicable continuing regulatory requirements, our business could be seriously harmed because a regulatory agency may:

| ● | issue                        
 untitled or warning letters; |

| ● | suspend                                                    
 or withdraw our regulatory approval for approved products; |

| ● | seize                                                                                                                          
 or detain products or recommend a product recall of a drug or medical device, or issue a mandatory recall of a medical device; |

| ● | refuse                                        
 import or export of any of our drug products; |

| ● | refuse                                                                               
 to approve pending applications or supplements to approved applications filed by us; |

| ● | suspend                      
 our ongoing clinical trials; |

| ● | restrict                                                                                                                              
 our operations, including costly new manufacturing requirements, or restrict the sale, marketing and/or distribution of our products; |

| ● | seek           
 an injunction; |

| ● | pursue                 
 criminal prosecutions; |

| ● | close                                            
 the facilities of our contract manufacturers; or |

| ● | impose                       
 civil or criminal penalties. |

36 We could become subject to false claims litigation under federal statutes, which can lead to civil money penalties, restitution, criminal fines and imprisonment, and exclusion from participation in Medicare, Medicaid and other federal and state health care programs. False claims statutes include the False Claims Act, which allows any person to bring a suit on behalf of the federal government alleging submission of false or fraudulent claims, or causing to present such false or fraudulent claims, under federal programs or contracts claims or other violations of the statute and to share in any amounts paid by the entity to the government in fines or settlement. These suits against pharmaceutical companies have increased significantly in volume and breadth in recent years. Some of these suits