Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 44

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 44
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 validity or enforceability, and our patents may be challenged in the courts or patent offices in the United
States and abroad. We may be subject to a third-party preissuance submission of prior art to the USPTO, or become involved in opposition,
derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging our patent rights or
the patent rights of others, or other proceedings in the USPTO or applicable foreign offices that challenge priority of invention or other
features of patentability. An adverse determination in any such submission, proceeding or litigation could result in loss of exclusivity
or ability to sell our products free from infringing the patents of third parties, patent claims being narrowed, invalidated or held unenforceable,
in whole or in part, and limitation of the scope or duration of the patents directed to our drug candidates, all of which could limit
our ability to stop others from using or commercializing similar or identical drug candidates or technology to compete directly with us,
without payment to us, or result in our inability to manufacture or commercialize drug candidates or approved products (if any) without
infringing third-party patent rights. In addition, if the breadth or strength of the claims of our patents and patent applications is
threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop or commercialize current
or future drug candidates, or could have a material adverse effect on our ability to raise funds necessary to continue our research programs
or clinical trials. Such proceedings also may result in substantial cost and require significant time from our scientists and management,
even if the eventual outcome is favorable to us.

In addition, given the amount of time required
for the development, testing and regulatory review of new drug candidates, patents protecting such candidates might expire before or shortly
after such candidates are commercialized. As a result, our patent portfolio may not provide us with sufficient rights to exclude others
from commercializing products or technology similar or identical to ours for a meaningful amount of time, or at all. Moreover, some of
our licensed patents and owned or licensed patent applications may in the future be co-owned with third parties. If we are unable to obtain
exclusive licenses to any such co-owners’ interest in such patents or patent applications, such co-owners may be able to license
their rights to other third parties, including our competitors, and our competitors could market competing products and technology. In
addition, we may need