Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 146

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 146
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on our own. Negative results in investigator-initiated clinical trials could have a material adverse effect on our efforts to obtain regulatory
approval for our product candidates and the public perception of our product candidates. As a result, our lack of control over the conduct
and timing of and communications with the FDA and other regulatory authorities regarding investigator-sponsored trials may expose us to
additional risks and uncertainties, many of which are outside our control, and the occurrence of which could adversely affect the commercial
prospects for our product candidates.

We rely on third parties
to manufacture our product candidates, and we expect to continue to rely on third parties for the clinical as well as any future commercial
supply of our product candidates and other future product candidates. The development of our current and future product candidates, and
the commercialization of any approved products, could be stopped, delayed or made less profitable if any such third party fails to provide
us with sufficient clinical or commercial quantities of such product candidates or products, fails to do so at acceptable quality levels
or prices or fails to achieve or maintain satisfactory regulatory compliance.

We do not currently
have, and we do not have immediate plans to build, the infrastructure or capability internally to manufacture current product candidates
or any future product candidates for use in the conduct of our clinical trials or, if approved, for commercial supply. We are in the process
of developing our supply chain for each of our current product candidates and intend to put in place framework agreements under which
third-party CMOs will generally provide us with necessary quantities of parts, API and drug product on a project-by-project basis based
on our development needs. Reliance on third-party providers may expose us to more risk than if we were to manufacture our product candidates
ourselves. We do not control the manufacturing processes of the CMOs we may contract with and are dependent on those third parties for
the production of our product candidates in accordance with relevant applicable regulations such as cGMP and QSR, which includes, among
other things, quality control, quality assurance and the maintenance of records and documentation.

In complying
with the manufacturing regulations of the FDA and other comparable foreign regulatory authorities, we and our third-party suppliers will
need to spend significant time, money and effort in the areas of design and development, testing, production, record-keeping and quality
control to assure that the products meet applicable specifications and other regulatory requirements. The failure to comply with these
requirements could result in an enforcement action against us, including the seizure of