Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 36

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 36
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 are an early stage development company with
limited resources. Even if we had products available for sale, which we currently do not, we have not secured sales and marketing staff
at this early stage of operations to sell products. We cannot generate sales without sales or marketing staff and must rely on others
to provide any sales or marketing services until such personnel are secured, if ever. If we fail to hire and retain the requisite expertise
in order to market and sell our products or fail to raise sufficient capital in order to afford to pay such sales or marketing staff,
then we could be forced to cease operations and you could lose all of your investment.

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Even if we were to successfully develop approvable drugs, we will not be able to sell these drugs if we or our third-party manufacturers fail to comply with manufacturing regulations, which could have a materially adverse effect on our business.

If we were to successfully develop approvable
drugs, before we can begin selling these drugs, we must obtain regulatory approval of our manufacturing facility and process or the manufacturing
facility and process of the third party or parties with whom we may outsource our manufacturing activities. In addition, the manufacture
of our products must comply with the FDA’s current Good Manufacturing Practices regulations, commonly known as GMP regulations.
The GMP regulations govern quality control and documentation policies and procedures. Our manufacturing facilities, if any in the future,
and the manufacturing facilities of our third-party manufacturers will be continually subject to inspection by the FDA and other state,
local and foreign regulatory authorities, before and after product approval. We cannot guarantee that we, or any potential third-party
manufacturer of our products, will be able to comply with the GMP regulations or other applicable manufacturing regulations. The failure
to comply with all necessary regulations would have a materially adverse effect on our business and could force us to cease operations
and you could lose all of your investment.

We must comply with significant and complex government regulations, compliance with which may delay or prevent the commercialization of our product candidates, which could have a materially adverse effect on our business.

The R&D, manufacture and marketing of drug
product candidates are subject to regulation, primarily by the FDA in the United States and by comparable authorities in other countries.
These national agencies and other federal, state, local and foreign entities regulate, among other things, R&D activities (including
testing in animals and in humans) and the testing, manufacturing, handling, labeling, storage, record keeping, approval, advertising and