Company: BIVIW
Filing Date: 2025-11-10
Form Type: 10-Q
Source: 0001520138-25-000343
Chunk: 82

Company: BIOVIE INC.
Filing Date: 2025-11-10
Form: 10-Q
Item: Part I, Item 2
Chunk 82
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 securities class action, and related claims for unjust enrichment, waste
of corporate assets, gross mismanagement, and abuse of control. On September 29, 2025, at the request of the parties, the court consolidated
all three Related Derivative Lawsuits under the caption In re BioVie Inc. Derivative Litigation, Case No. 3:24-cv-0602-CSD.

The Company believes that the claims are without
merit and intends to defend vigorously against them, but there can be no assurances as to the outcome.

Item 1A. Risk Factors 

Except as described below, there have been no
material changes to the Risk Factors previously disclosed in our 2025 Form 10-K. The risks described in our 2025 Form 10-K and below are
not the only risks facing our company. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial
also may materially adversely affect our business, financial condition, and/or operating results.

27

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 us 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