Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 39

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 39
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 factual considerations
and, therefore, validity and enforceability cannot be predicted with certainty. Patents may be challenged, deemed unenforceable, invalidated
or circumvented.

We have five granted and seven pending patent
applications for our liquid formulations of terlipressen that claim priority to PCT/US2020/034269 filed on May 22, 2020 and published
as WO2020/237170. We also have thirteen (13) issued U.S. patents, five (5) pending U.S. applications, three (3) pending Patent Cooperation
Treaty applications four (4) issued foreign patents and eight (8) pending foreign patent applications directed to protecting bezisterm
(NE3107) and related compounds and methods of making and using thereof. However, there can be no assurance that our pending patent applications
will result in issued patents, or that any issued patent claims from pending or future patent applications will be sufficiently broad
to protect BIV201, bezisterim (NE3107), or any other product candidates or to provide us with competitive advantages.

We can provide no assurance that any issued patents
will provide us with any competitive advantage. We cannot be certain that there is no invalidating prior art of which we and the patent
examiner are unaware or that our interpretation of the relevance of prior art is correct. If a third-party patent or patent application
is determined to have an earlier priority date, it may prevent our patent applications from issuing at all or issuing in a form that provides
any competitive advantage for our drug candidates. Failure to obtain additional issued patents could have a material adverse effect on
our ability to develop and commercialize our drug candidates. Even if our patent applications do issue as patents, third parties may be
able to challenge the validity and enforceability of our patents on a variety of grounds, including that such third party’s patents
and patent applications have an earlier priority date, and if such challenges are successful, we may be required to obtain one or more
licenses from such third parties, if available on commercially reasonable terms, or be prohibited from commercializing our drug candidates.

We seek to protect our proprietary positions by,
among other things, filing patent applications in the United States and abroad related to our current drug candidates and other drug candidates
that we may identify. Obtaining, maintaining, defending and enforcing pharmaceutical patents is costly, time-consuming and complex, and
we may not be able to file and prosecute all necessary or desirable patent applications, or