Company: SXTPW
Filing Date: 2025-03-27
Form Type: S-1/A
Source: 0001013762-25-003353
Chunk: 64

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: S-1/A
Chunk 64
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 for sale, audit the manufacturing facilities of our third-party contractors or raw material suppliers. If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our product specifications or applicable regulations occurs independent of such an inspection or audit, the relevant regulatory authority may require remedial measures that may be costly and time-consuming to implement and that may include the temporary or permanent suspension of a clinical trial or commercial sales or the temporary or permanent closure of a facility. Our third-party contractors or raw material suppliers may refuse to implement remedial measures required by regulatory authorities. Any failure to comply with applicable manufacturing regulations or failure to implement required remedial measures imposed upon third parties with whom we contract could materially harm our business. We rely on relationships with third-party contract manufacturers and raw material suppliers, which limits our ability to control the availability of, and manufacturing costs for, our product candidates. Problems with any of our contract manufacturers’ or raw material suppliers’ facilities or processes, could prevent or delay the production of adequate supplies of finished products. This could delay clinical trials or delay and reduce commercial sales and materially harm our business. Any prolonged delay or interruption in the operations of our collaborators’ facilities or contract manufacturers’ 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; |

37

| ● | 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