Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 147

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 147
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 products and shutting down of production. We and
any of these third-party suppliers may also be subject to inspections by the FDA or comparable foreign regulatory authorities. If any
of our third-party suppliers fails to comply with cGMP or other applicable manufacturing regulations, our ability to develop and commercialize
our product candidates could suffer significant interruptions.

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Our failure,
or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us,
including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures
or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect
supplies of our products.

Any disruption,
such as a fire, natural hazards or vandalism at our CMOs, or any impacts on our CMOs due to the COVID-19 pandemic, could significantly
interrupt our manufacturing capability. If this occurs, we will be unable to satisfy manufacturing needs on a timely basis, if at all.
If changes to CMOs occur, then there also may be changes to manufacturing processes inherent in the setup of new operations for our product
candidates and any products that may obtain approval in the future. Any such changes could require the conduct of bridging studies before
we can use any materials produced at new facilities or under new processes in clinical trials or, for any products reaching approval,
in our commercial supply. Further, business interruption insurance may not adequately compensate us for any losses that may occur and
we would have to bear the additional cost of any disruption. For these reasons, a significant disruptive event of any CMOs could have
drastic consequences, including placing our financial stability at risk.

Our product candidates
and any products that we may develop may compete with other product candidates for access to manufacturing facilities. There are no assurances
we would be able to enter into similar commercial arrangements with other manufacturers that operate in accordance with cGMP and/or other
applicable requirements and that might be capable of manufacturing for us. Any performance failure on the part of our existing or future
manufacturers could delay clinical development or marketing approval.

If we were to
experience an unexpected loss of supply of or if any supplier were unable to meet our clinical or commercial demand for any of our product
candidates, we could experience delays in our planned clinical studies or commercialization. For example, the COVID-19 pandemic may impact
our ability to procure sufficient supplies for the development of our current and