Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 142

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 142
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 | The development of manufacturing capabilities to produce clinical supply may require third-party manufacturers                         
 to invest substantial additional funds and to hire and retain technical personnel who have the necessary manufacturing experience. The 
 third-party manufacturers may fail to devote sufficient time and resources to develop the capabilities to manufacture our product.     |

| ● | The third-party manufacturer, or other third parties we relies on, may encounter difficulties in achieving                                 
 the volume of production needed to satisfy demands, may not be able to achieve such volume at an acceptable cost, may experience technical 
 issues that impact comparability, quality, or compliance with applicable regulations governing the manufacture of the regulated products,  
 and may experience shortages of qualified personnel to adequately staff production operations.                                             |

| ● | Third-party manufacturers could default on their agreements to meet the product requirements, or they                                   
 may terminate or decide not to renew their agreements based on their own business priorities, at a time that is costly or damaging to   
 us. If our third-party manufacturers were to terminate its arrangements or fail to meet its manufacturing demands, we may be delayed in 
 the ability to obtain and maintain product regulatory approvals.                                                                        |

| ● | If any third-party manufacturer makes improvements in the manufacturing process, we may not own, or may 
 have to share, the intellectual property rights to such improvements.                                   |

| ● | A third-party manufacturer may gain knowledge from working with us that could be used to supply one of 
 its competitors with a product that competes with our product.                                         |

Our reliance
on third-party manufacturers reduces the control over production but does not relieve our responsibility to ensure compliance with applicable
legal and regulatory standards. The FDA and other non-U.S. regulatory authorities require that product candidates and any products that
we may eventually commercialize be manufactured according to cGMP and similar non-U.S. standards. Methods of manufacture as well as validation
of manufacturing procedures and quality control systems are reviewed by regulatory authorities. All such manufacturing procedures, validation
programs and quality assessment activities must be properly documented in accordance with regulatory requirements. Any failure by the
third-party manufacturers to comply with cGMP or similar non-U.S. standards, including any failure to deliver sufficient quantities of
product in a timely manner, could lead to a delay in or failure to obtain regulatory approval.

In addition,
a failure by third-party manufacturers to comply with cGMP or similar non-U.S. standards could be the basis for the FDA or any other non-U.S.
regulatory authorities to issue a warning or untitled letter