Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 28

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 28
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 drugs intended to treat, diagnose or prevent a life-threatening or chronically
debilitating disease having a prevalence of no more than five in 10,000 people in the EU, and which meet other specified criteria. The
company that first obtains FDA approval for a designated Orphan Drug for the associated rare disease may receive a seven-year period of
marketing exclusivity during which time FDA may not approve another application for the same drug for the same orphan disease or condition.
Orphan Drug Exclusivity does not prevent FDA approval of another application for the same drug for a different disease or condition, or
of an application for a different drug for the same rare disease or condition. Orphan Drug exclusive marketing rights may be lost under
several circumstances, including a later determination by the FDA that the request for designation was materially defective or if the
manufacturer is unable to assure sufficient quantity of the drug. Similar regulations are available in the EU with a ten-year period of
market exclusivity.

Even though BioVie has obtained two Orphan Drug
Designations for its lead product candidate, terlipressin, for treatment of ascites and for treatment of hepatorenal syndrome, and may
seek other Orphan Drug Designations for BIV201, and Orphan Drug Designation for other product candidates, there is no assurance that BioVie
will be the first to obtain marketing approval for any particular rare indication. Further, even though BioVie has obtained Orphan Drug
Designations for its lead product candidate, or even if BioVie obtains Orphan Drug Designation for other potential product candidates,
such designation may not effectively protect BioVie from competition because different drugs can be approved for the same condition and
the same drug can be approved for different conditions and potentially used off-label in the Orphan indication. Even after an Orphan Drug
is approved, the FDA can subsequently approve another competing drug with the same active ingredient for the same condition for several
reasons, including, if the FDA concludes that the later drug is clinically superior due to being safer or more effective or because it
makes a major contribution to patient care. Orphan Drug Designation neither shortens the development time or regulatory review time of
a drug, nor gives the drug any advantage in the regulatory review or approval process.

In addition, other companies have received Orphan
Drug designations for terlipressin. Mallinckrodt Hospital Products IP Limited received Orphan Drug designation in 2004 for terlipressin
for