Company: SXTPW
Filing Date: 2025-02-14
Form Type: S-1
Source: 0001213900-25-014334
Chunk: 72

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-02-14
Form: S-1
Chunk 72
---
’ facilities could result in cancellation of shipments, loss of components in the process of being manufactured or a shortfall in availability of a product candidate or products. A number of factors could cause interruptions, including, but not limited to:

| ● | the                                               
 inability of a supplier to provide raw materials; |

| ● | equipment                                                                     
 malfunctions or failures at the facilities of our collaborators or suppliers; |

40

| ● | high                   
 process failure rates; |

| ● | damage                                              
 to facilities due to natural or man-made disasters; |

| ● | changes                                                                                                                      
 in regulatory requirements or standards that require modifications to our or our collaborators’ and suppliers’ manufacturing 
 processes;                                                                                                                   |

| ● | action                                                                                                                                       
 by regulatory authorities or by us that results in the halting or slowdown of production of components or finished product at our facilities 
 or the facilities of our collaborators or suppliers;                                                                                         |

| ● | problems                                                                                                                                 
 that delay or prevent manufacturing technology transfer to another facility, contract manufacturer or collaborator with subsequent delay 
 or inability to start up a commercial facility;                                                                                          |

| ● | a                                                                                                                                                 
 contract manufacturer or supplier going out of business, undergoing a capacity shortfall or otherwise failing to produce product as contractually 
 required;                                                                                                                                         |

| ● | employee                                    
 or contractor misconduct or negligence; and |

| ● | shipping                                                    
 delays, losses or interruptions; and other similar factors. |

Because manufacturing processes are complex and are subject to a lengthy regulatory approval process, alternative qualified production capacity and sufficiently trained or qualified personnel may not be available on a timely or cost-effective basis or at all. Difficulties or delays in our contract manufacturers’ production of drug substances could delay our clinical trials, increase our costs, damage our reputation and cause us to lose revenue and market share if we are unable to timely meet market demand for any products that are approved for sale. The manufacturing process for our product candidates has several components that are sourced from a single manufacturer. If we utilize an alternative manufacturer or alternative component, we may be required to demonstrate comparability of the drug product before releasing the product for clinical use and we may not be able to find an alternative supplier. Further, if our contract manufacturers are not in compliance with regulatory requirements at any stage, including post-marketing approval, we may be fined, forced to remove a product from the market and/or experience other adverse consequences, including delays, which could materially harm our business. Even if one of our product candidates receives marketing approval, it may fail to achieve the degree