Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 27

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 27
---
DA. Specifically, in cases where such exclusivity has been granted, an ANDA
may not be submitted to the FDA until the expiration of five years unless the submission is accompanied by a Paragraph IV certification
that a patent covering the reference listed drug is either invalid or will not be infringed by the generic product, in which case the
applicant may submit its application four years following approval of the reference listed drug. If an ANDA is submitted to FDA with a
Paragraph IV Certification, the generic applicant must also provide a “Paragraph IV Notification” to the holder of the NDA
for the RLD and to the owner of the listed patent(s) being challenged by the ANDA applicant, providing a detailed written statement of
the basis for the ANDA applicant’s position that the relevant patent(s) is invalid or would not be infringed. If the patent owner
brings a patent infringement lawsuit against the ANDA applicant within 45 days of the Paragraph IV Notification, FDA approval of the ANDA
will be automatically stayed for 30 months, or until 7-1/2 years after the NDA approval if the generic application was filed between 4
years and 5 years after the NDA approval. Any such stay will be terminated earlier if the court rules that the patent is invalid or would
not be infringed.

Competition that our products may face from generic
versions of our products could materially and adversely impact our future revenue, profitability and cash flows and substantially limit
our ability to obtain a return on the investments we have made in those product candidates.

If we fail to obtain or maintain Orphan Drug exclusivity for BIV201, we will have to rely on other potential marketing exclusivity, and on our intellectual property rights, which may reduce the length of time that we can prevent competitors from selling generic versions of BIV201.

We have obtained Orphan Drug Designation for BIV201
(terlipressin) in the U.S. for the treatment of hepatorenal syndrome on November 21, 2018 and treatment of ascites due to all etiologies
except cancer on September 8, 2016. Under the Orphan Drug Act, the FDA may designate a product as an Orphan Drug if it is a drug intended
to treat a rare disease or condition, defined, in part, as a patient population of fewer than 200,000 in the U.S. In the European Union
(“EU”), Orphan Drug designation may be granted to