Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 42

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 42
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 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 maintain, enforce and license any patents
that may issue from such patent applications, at a reasonable cost or in a timely manner. It is also possible that we will fail to identify
patentable aspects of our research and development output before it is too late to obtain patent protection. Moreover, under certain of
our license or collaboration agreements, we may not have the right to control the preparation, filing, prosecution and maintenance of
patent applications, or to maintain the rights to patents licensed to or from third parties.

We currently are the assignee of a number of U.S.
provisional patent applications. U.S. provisional patent applications are not eligible to become issued patents until, among other things,
we file a non-provisional patent application within 12 months of filing one or more of our related provisional patent applications. With
regard to such U.S. provisional patent applications, if we do not timely file any non-provisional patent applications, we may lose our
priority dates with respect to our provisional patent applications and any patent protection on the inventions disclosed in our provisional
patent applications. Further, in the event that we do timely file non-provisional patent applications relating to our provisional patent
applications, we cannot predict whether any such patent applications will result in the issuance of patents or if such issued patents
will provide us with any competitive advantage.

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As to our material inventions, trade secrets,
and intellectual property, our employees, consultants, and advisors execute confidentiality agreements and agree to disclose and assign
to us all inventions conceived during the workday