Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 58

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 58
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 review, inter partes review or derivation proceedings before the USPTO or an equivalent foreign body.
Numerous U.S.- and foreign-issued patents and pending patent applications owned by third parties exist in the fields in which we are developing
our drug candidates. Third parties may assert infringement claims against us based on existing patents or patents that may be granted
in the future, regardless of their merit.

We do not believe that either BIV201 or bezisterim
(NE3107), the product candidates we are currently developing, infringe the patents of any third parties. However, there can be no assurance
that our technology will not be found in the future to infringe the patents of others. Moreover, patent applications are in some cases
maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patent literature frequently occurs
substantially later than the date on which the underlying discoveries were made and patent applications were filed. Because patents can
take many years to issue, there may be currently pending applications of which we are unaware that may later result in issued patents
that our products or product candidates infringe. For example, pending applications may exist that provide support or can be amended to
provide support for a claim that results in an issued patent that our product infringes.

Even if we believe third-party intellectual property
claims are without merit, there is no assurance that a court would find in our favor on questions of claim scope, infringement, validity,
enforceability or priority. A court of competent jurisdiction could hold that third-party patents asserted against us are valid, enforceable
and infringed, which could materially and adversely affect our ability to commercialize any drug candidates we may develop and any other
drug candidates or technologies covered by the asserted third-party patents. In order to successfully challenge the validity of any such
U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present
clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction
would invalidate the claims of any such U.S. patent.

If we are found to infringe, misappropriate or
otherwise violate a third party’s intellectual property rights, and we are unsuccessful in demonstrating that such rights are invalid
or unenforceable, we could be required to obtain a license from such a third party in order to continue developing and marketing our products
and technology. However,