Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 41

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 41
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 and is therefore unenforceable.

Risks Relating to Our Intellectual Property

We may be unable to obtain or protect intellectual property rights relating to our product candidates, which could have a materially adverse effect on our business.

Our ability to compete effectively will depend
on our ability to maintain the proprietary nature of our technologies. We cannot assure investors that we will continue to innovate and
file new patent applications, or that if filed any future patent applications will result in granted patents with respect to the technology
owned by us or licensed to us. Further, we cannot predict how long it will take for such patents to issue, if at all. The patent position
of pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves complex legal and 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