Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 54

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 54
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 prosecution of patent applications and the enforcement or defense of issued patents.
Any of the foregoing could harm our business, financial condition, results of operations and prospects.

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We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and issued patents directed towards our technology and drug candidates could be found invalid or unenforceable if challenged.

We are not aware that our patents directed to
either BIV201 or bezisterim (NE3107), the product candidates we are currently developing, are infringed by third parties. However, there
can be no assurance that our patents will not be found in the future to be infringed by others. Any patents we do obtain may be challenged
by reexamination or otherwise invalidated or eventually found unenforceable. Both the patent application process and the process of managing
patent disputes can be time-consuming and expensive.

Significantly, our pending patent applications
cannot be enforced against third parties practicing the technology claimed in such applications unless and until a patent issues from
such applications. Our ability to enforce patent rights also depends on our ability to identify infringement. It may be difficult to identify
infringers who do not advertise the components or methods that are used in connection with their products and services. Moreover, it may
be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product or service.
Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe
their patents or that our patents are invalid or unenforceable. In a patent infringement proceeding, a court may decide that a patent
of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party
from using the technology at issue on the grounds that our patents do not cover the technology. An adverse result in any litigation proceeding
could put one or more of our owned or licensed patents at risk of being invalidated, held unenforceable or interpreted narrowly. We may
find it impractical or undesirable to enforce our intellectual property against some third parties.

If we were to initiate legal proceedings against
a third party to enforce a patent directed to our drug candidates, or one of our future drug candidates, the defendant could counterclaim
that our patent is invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging