Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 411

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 411
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 U.S. teaching      
 hospitals, as well as track and report certain ownership and investment interests held in the manufacturer by physicians and their         
 immediate families;                                                                                                                        |

| ● | analogous                                                                                                                                     
 state laws and regulations, such as state anti-kickback and false claims laws, that impose similar restrictions as their federal counterparts 
 and may apply to our business practices, including sales or marketing arrangements and claims involving healthcare items or services          
 reimbursed by non-governmental third-party payors, including private insurers;                                                                |

| 223 |

| ● | state                                                                                                                                        
 laws that require pharmaceutical companies to implement compliance programs, comply with the pharmaceutical industry’s voluntary             
 compliance guidelines and the relevant compliance guidance promulgated by the federal government, or to track and report gifts, compensation 
 and other remuneration provided to physicians and other health care providers;                                                               |

| ● | state                                                                                                                                    
 laws that require disclosures related to state agencies and/or commercial purchasers with respect to certain price increases that exceed 
 a certain level as identified in the relevant statutes;                                                                                  |

| ● | state                                                                              
 and local laws requiring the registration of pharmaceutical sales representatives; |

| ● | state                                                                                                                                       
 health information privacy and data breach notification laws, which govern the collection, use, disclosure and protection of health-related 
 and other personal information, many of which differ from each other in significant ways and often are not pre-empted by HIPAA, thus        
 complicating compliance efforts; and                                                                                                        |

| ● | state                                                                                                                                            
 unfair and deceptive trade practices statutes, pursuant to which significant statutory fines and penalties can be imposed against pharmaceutical 
 companies alleged to have engaged in consumer fraud.                                                                                             |

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial resources and costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that

may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion of product candidates from government-funded healthcare programs, such as Medicare and Medicaid, disgorgement, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations. If any physicians or other healthcare providers or entities with whom we expect to do business are found not to be in compliance with applicable