Company: SXTPW
Filing Date: 2025-03-27
Form Type: S-1/A
Source: 0001013762-25-003353
Chunk: 140

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: S-1/A
Chunk 140
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 and export of pharmaceutical products. The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and financial resources.

| 67 | Novitt-Moreno                 
 et al. TMAID 2022; 45:102211. |

| 68 | See                                                              
 Industry Research and Development Act 1986 (legislation.gov.au). |

| 69 | See                                                                        
 Australian Government R&D Tax Incentive – Overseas R&D: Information Sheet. |

87 Review and Approval of Drugs in the United States In the United States, the FDA regulates, among other things, the research, development, testing, manufacturing, approval, labeling, storage, recordkeeping, advertising, promotion and marketing, distribution, post approval monitoring and reporting and import and export of drugs in the U.S. to assure the safety and effectiveness of medical products for their intended use under the Federal Food, Drug, and Cosmetic Act (“FDCA”), and implementing regulations. The failure to comply with applicable U.S. requirements at any time during the product development process, approval process or after approval may subject an applicant and/or sponsor to a variety of administrative or judicial sanctions, including refusal by the FDA to approve pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of warning letters and other types of letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, denial of the ability to import and export certain products, restitution, disgorgement of profits, or civil or criminal investigations and penalties brought by the FDA and the Department of Justice or other governmental entities. An applicant seeking approval to market and distribute a new drug product in the United States must typically undertake the following:

| ● | completion                                                                                                                    
 of preclinical laboratory tests, animal studies and formulation studies in compliance with the FDA’s good laboratory practice 
 regulations;                                                                                                                  |

| ● | submission to the FDA of                                               
 an IND, which must take effect before human clinical trials may begin; |

| ● | approval by an independent                                                                              
 institutional review board representing each clinical site before each clinical trial may be initiated; |

| ● | performance of adequate                                                                                                          
 and well-controlled human clinical trials in accordance with good clinical practices to establish the safety and efficacy of the 
 proposed drug product for each indication;                                                                                       |

| ● | preparation and submission            
 to the FDA of a