Company: BIVIW
Filing Date: 2025-08-04
Form Type: S-1/A
Source: 0001520138-25-000235
Chunk: 35

Company: BIOVIE INC.
Filing Date: 2025-08-04
Form: S-1/A
Chunk 35
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you to lose all of your investment.

In addition, the FDA and other regulatory authorities
require that product candidates and drug products be manufactured according to cGMP. Any failure by our third-party manufacturers to comply
with cGMP could lead to a shortage of BIV201 and NE3107. In addition, such failure could be the basis for action by the FDA to withdraw
approval, if granted to us, and for other regulatory enforcement action, including Warning Letters, product seizure, injunction or other
civil or criminal penalties.

BIV201 and bezisterim (NE3107) and any other product
candidates that we develop may have to compete with other products and product candidates for access to manufacturing facilities. There
are a limited number of manufacturers that operate under cGMP regulations and that are both capable of manufacturing for us and willing
to do so. If we need to find another source of drug substance or drug product manufacturing for BIV201 and bezisterim (NE3107), we may
not be able to identify, or reach agreement with, commercial-scale manufacturers on commercially reasonably terms, or at all. If we are
unable to do so, we will need to develop our own commercial-scale manufacturing capabilities, which would: impact commercialization of
BIV201 and bezisterim (NE3107) in the U.S. and other countries where it may be approved; require a capital investment by us that could
be quite costly; and increase our operating expenses.

If our existing third-party manufacturers, or
the third parties that we engage in the future to manufacture a product for commercial sale or for our clinical trials, should cease to
continue to do so for any reason, we likely would experience significant delays in obtaining sufficient quantities of product for us to
meet commercial demand or to advance our clinical trials while we identify and qualify replacement suppliers. If for any reason we are
unable to obtain adequate supplies of BIV201 or any other product candidate that we develop, or the drug substances used to manufacture
it, it will be more difficult for us to compete effectively, generate revenue, and further develop our products. In addition, if we are
unable to assure a sufficient quantity of the drug for patients with rare diseases or conditions, we may lose any Orphan Drug exclusivity
to which the product otherwise would be entitled.

We do not currently have the sales and marketing personnel necessary to sell products, and the failure to hire and retain such staff could have a materially adverse effect on our business.

We