Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 59

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 59
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cannot extend the remaining term of a patent beyond a total of 14 years from the date of diagnostic test or therapeutic product approval,
and only claims covering such approved diagnostic test or drug product, a method for using it, or a method for manufacturing it may be
extended. In Europe, our diagnostic test or therapeutic 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 an 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 diagnostic tests or products sooner. The resulting reduction of years of revenue
from applicable diagnostic tests or products could be substantial.

We enjoy only limited geographical protection with respect to certain patents, and we may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting, and defending patents covering
our diagnostic tests and therapeutic product candidates in all countries throughout the world would be prohibitively expensive, and even
in countries where we have sought protection for our intellectual property, such protection can be less extensive than it is in the U.S.
The requirements for patentability may differ in certain countries, particularly developing countries, and the breadth of patent claims
allowed can be inconsistent. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent
as federal and state laws in the U.S. In-licensing patents covering our diagnostic tests and therapeutic product candidates in all countries
throughout the world may similarly be prohibitively expensive, if such opportunities are available at all. And in-licensing or filing,
prosecuting, and defending patents even in only those jurisdictions in which we develop or commercialize our diagnostic tests and therapeutic
product candidates may be prohibitively expensive or impractical. Competitors may use our and our licensors’ technologies in jurisdictions
where we have not obtained patent protection or licensed patents to develop their own diagnostic tests and therapeutic products and further
may export otherwise infringing products to territories where we and our licensors have patent protection, but where enforcement is not
as strong as that in the U.S. or Europe. These diagnostic tests