Company: BIVIW
Filing Date: 2025-05-12
Form Type: 10-Q
Source: 0001520138-25-000144
Chunk: 88

Company: BIOVIE INC.
Filing Date: 2025-05-12
Form: 10-Q
Item: Part I, Item 8
Chunk 88
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 ended September 30, 2024 (the “Q1 2025 10-Q”) and our quarterly report for
the period ended December 31, 2024 (the “Q2 2025 10-Q”). The risks described in our 2024 Form 10-K, our Q1 2025 10-Q, our
Q2 2025 10-Q and below are not the only risks facing our Company. Additional risks and uncertainties not currently known to the Company
or that we currently deem to be immaterial also may materially adversely affect our business, financial condition, and/or operating results.

Risks Relating to Our Business and Industry

We rely and will continue to rely on third parties
to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines
or do not successfully perform and comply with regulatory requirements, we may not be able to obtain regulatory approval of or commercialize
our product candidates.

We depend, and will continue to depend, on third parties,
including, but not limited to, contract research organizations (“CROs”), clinical trial sites and clinical trial principal
investigators, contract laboratories, IRBs, manufacturers, suppliers, and other third parties to conduct our clinical trials, including
those for our drug candidates bezisterim (NE3107) and BIV201. We rely heavily on these third parties over the course of our clinical trials,
and we control only certain aspects of their activities. Nevertheless, we retain ultimate responsibility for ensuring that each of our
studies is conducted in accordance with the protocol and applicable legal, regulatory, and scientific standards and regulations, and our
reliance on third parties does not relieve the Company of our regulatory responsibilities. We and these third parties are required to
comply with cGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for the conduct
of clinical trials on product candidates in clinical development. Regulatory authorities enforce cGCPs through periodic inspections and
for-cause inspections of clinical trial principal investigators and trial sites. If, due to the failure of either the Company or a third
party, a clinical trial fails to comply with applicable cGCPs, FDA’s IND requirements, other applicable regulatory requirements,
or requirements set forth in the applicable IRB-approved protocol, the Company may be required to conduct additional clinical trials to
support our marketing applications, which would delay the regulatory approval process.

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Although we design the