Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 97

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 97
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 parties for the
production of our product candidates. Manufacturers of our product candidates are required to comply with applicable FDA manufacturing
requirements contained in the FDA’s cGMP regulations. cGMP regulations require among other things, quality control and quality assurance
as well as the corresponding maintenance of comprehensive records and documentation. Drug and biologic manufacturers and other entities
involved in the manufacture and distribution of approved drugs and biologics are also required to register their establishments and list
any products made there with the FDA and comply with related requirements in certain states, and are subject to periodic unannounced inspections
by the FDA and certain state agencies for compliance with cGMP and other laws. Accordingly, manufacturers must continue to expend time,
money and effort in the area of production and quality control to maintain cGMP compliance. Discovery of problems with a product after
approval may result in serious and extensive restrictions on a product, manufacturer, or holder of an approved NDA or BLA, including suspension
of a product until the FDA is assured that quality standards can be met, continuing oversight of manufacturing by the FDA under a “consent
decree,” which frequently includes the imposition of costs and continuing inspections over a period of many years, and possible
withdrawal of the product from the market. In addition, changes to the manufacturing process generally require prior FDA approval before
being implemented and other types of changes to the approved product, such as adding new indications and additional labeling claims, are
also subject to further FDA review and approval.

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The FDA also may require post-marketing testing,
known as Phase 4 testing, risk minimization action plans and surveillance to monitor the effects of an approved product or place conditions
on an approval that could otherwise restrict the distribution or use of the product.

Employees

Our business is managed by our officers who consist of Mr. Cuong Do,
Chief Executive Officer & President; Dr. Joseph M Columbo, Executive Vice President -Chief Medical Officer; and Wendy Kim, our Chief
Financial Officer and Corporate Secretary. These individuals devote their full-time efforts to the Company activities. The Company has
13 employees which are all full time. We also rely on a team of highly experienced scientific, medical, and regulatory consultants to
conduct product development activities.

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS</div>

The following discussion of the Company’s financial condition and the results of operations should