Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 177

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 177
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, but the life of a patent and, correspondingly, the protection it affords
is limited. Even if we or our licensors obtain patents covering our products, when the terms of all patents covering a product expire,
our business may become subject to competition from products identical or similar to ours which can be sold without infringing our patents.
As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing
products similar or identical to ours.

We may be unable to acquire
patent term extension in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation.

In the United
States, a patent that covers a medical device or biological or pharmaceutical product approved by the FDA may be eligible for a term extension
designed to restore the period of the patent term that is lost during the pre-market regulatory review process conducted by the FDA. Depending
upon the timing, duration and conditions of FDA marketing approval of our products, one or more of our U.S. patents may be eligible for
limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”),
which permits a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent
term lost during product development and the FDA regulatory review process. A patent term extension cannot extend the remaining term of
a patent beyond a total of 14 years from the date of product approval, and only claims covering such approved drug product, a method for
using it or a method for manufacturing it may be extended. In the EU, our product candidates may be eligible for term extensions based
on similar legislation. In either jurisdiction, however, we may not receive an extension if we fail to apply within applicable deadlines,
fail to apply prior to expiration of relevant patents or otherwise fail to satisfy applicable requirements. Even if we are granted such
extension, the duration of such extension may be less than our request. If we are unable to obtain a patent term extension, or if the
term of any such extension is less than our request, the period during which we can enforce our patent rights for that product will be
in effect shortened and our competitors may obtain approval to market competing products sooner. The resulting reduction of years of revenue
from applicable products could be substantial.

We may need to obtain intellectual
property rights from third parties, and may not be successful in obtaining necessary rights to develop any future product through acquisitions