Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 55

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 55
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 invalidity or
unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements,
including lack of novelty, obviousness, non-enablement or insufficient written description. Grounds for a presentability assertion could
be an allegation that someone connected with prosecution of the patent withheld material information from the USPTO or made a misleading
statement during prosecution. Third parties may also raise similar claims before the USPTO or an equivalent foreign body, even outside
the context of litigation. Potential proceedings include reexamination, post-grant review, inter partes review, interference proceedings,
derivation proceedings and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result
in the revocation of, cancellation of, or amendment to our patents in such a way that they no longer cover our technology or any drug
candidates that we may develop. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect
to the validity question, for example, we cannot be certain that there is no invalidating prior art of which we and the patent examiner
were unaware during prosecution. These assertions may also be based on information known to us or the USPTO. If a defendant were to prevail
on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent rights directed towards
the applicable drug candidates or technology related to the patent rendered invalid or unenforceable. Such a loss of patent rights would
materially harm our business, financial condition, results of operations and prospects.

Interference proceedings provoked by third parties
or brought by us or declared by the USPTO may be necessary to determine the priority of inventions with respect to our patents or patent
applications. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from
the prevailing party. Our business could be materially harmed if the prevailing party does not offer us a license on commercially reasonable
terms or at all.

Furthermore, because of the substantial amount
of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could
be compromised by disclosure during this type of litigation.

The pharmaceutical industry is characterized by
extensive litigation regarding patents and other intellectual property rights. Moreover, the cost to us of any litigation or other proceeding
relating to our patents and other intellectual property rights, even if resolved in our favor, could be