Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 143

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 143
---
, withdraw approvals, or take other regulatory or legal action, including
recall or seizure, total or partial suspension of production, suspension of on-going clinical trials, refusal to approval pending applications

or supplemental applications, detention
of product, refusal to permit the import or export of products, injunction, imposing administrative or civil penalties or pursuing criminal
prosecution.

We may in the future bring
certain cGMP product release testing, stability testing and cGMP pharmaceutical manufacturing capabilities in-house, and we may not be
able to do so successfully or in compliance with FDA regulations.

We may bring
certain manufacturing activities in-house in the future. To the extent we do bring these functions in-house, we will be directly subject
to FDA and other requirements with respect to these activities, such as the FDA’s good laboratory practice (GLP) requirements, cGMP
regulations and similar foreign requirements. We cannot provide assurance that we will be able to perform these functions effectively
or comply with applicable regulations if we bring these functions in-house.

| 60 |

We may expend our limited
resources to pursue a particular product or indication and fail to capitalize on products or indications that may be more profitable or
for which there is a greater likelihood of success.

Because we have
limited financial and managerial resources, we focus on specific products and product candidates, indications and discovery programs.
As a result, we may forgo or delay pursuit of other opportunities with others that could have had greater commercial potential. Our resource
allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending
on current and future research and development programs for specific indications may not yield any commercially viable products. If we
do not accurately anticipate physician and patient needs, as well as evaluate the commercial potential or target market for a particular
potential product, we may miss valuable product development opportunities or we may relinquish valuable rights to that potential product
through future collaborations, licenses and other similar arrangements in cases in which it would have been more advantageous for us to
further advance development or to retain sole development and commercialization rights to such potential product.

Negative public opinion
and increased regulatory scrutiny of our operations may adversely impact the development or commercial success of our current and future
product candidates.

The clinical
and commercial success of our operations will depend in part on public acceptance of some of our technologies and product candidates.
Any adverse public attitudes about the use of our technologies may adversely impact our ability to enroll clinical trials. Moreover, our