Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 410

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 410
---
 the federal Anti-Kickback Statute are punishable by imprisonment for up to ten years and         
 statutory fines of up to $100,000. Additional criminal fines can be imposed under federal U.S. criminal procedure laws. Civil penalties       
 include statutory amounts of up to $100,000 (adjusted for inflation) per violation, assessments of up to three times the total payments       
 between the parties to the arrangement, and exclusion from participation in the federal healthcare programs or suspension from future         
 participation in Medicare and Medicaid. Further, violation of the federal Anti-Kickback Statute can also form the basis for False Claims      
 Act liability (discussed below). Although there are a number of statutory exceptions and regulatory safe harbors to the federal Anti-Kickback 
 Statute protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exceptions and           
 safe harbors are drawn narrowly, and practices that involve remuneration to those who prescribe, purchase, or recommend pharmaceutical        
 and biological products, may be subject to scrutiny if they do not fit squarely within an exception or safe harbor;                           |

| 222 |

| ● | the                                                                                                                                         
 federal civil False Claims Act, which may be enforced through civil whistleblower or qui tam actions and imposes significant                
 civil penalties, treble damages and potential exclusion from federal healthcare programs against individuals or entities for, among         
 other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent  
 or for making a false record or statement material to an obligation to pay the federal government or for knowingly and improperly avoiding, 
 decreasing or concealing an obligation to pay money to the federal government. Further, a violation of the federal Anti-Kickback Statute    
 can serve as a basis for liability under the federal civil False Claims Act. Manufacturers can be held liable under the FCA even though,    
 in most cases, they do not submit claims directly to government payors if they are deemed to “cause” the submission of                      
 false or fraudulent claims. FCA liability is potentially significant in the healthcare industry because the statute provides for treble     
 damages and significant mandatory penalties per false or fraudulent claim or statement for violations. Such per-claim penalties are         
 currently set at $13,508 to $27,018 per false claim or statement for penalties assessed after January 30, 2023, with respect to violations  
 occurring after November 2, 2015. Criminal penalties, including imprisonment and criminal fines, are also possible for making or presenting 
 a false