Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 34

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 34
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 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
promotion of the product that we are developing. Noncompliance with applicable requirements can result in various adverse consequences,
including approval delays or refusals to approve drug licenses or other applications, suspension or termination of clinical investigations,
revocation of approvals previously granted, warning letters, fines, criminal prosecution, recalls or seizures of products, injunctions
against shipping drugs and total or partial suspension of production and/or refusal to allow a company to enter into governmental supply
contracts.

The process of obtaining FDA approval is costly
and time consuming. Current FDA requirements for a new human drug or biological product to be marketed in the United States include, among
other things: (a) the successful conclusion of pre-clinical laboratory and animal tests, if appropriate, to gain preliminary information
on the product’s safety; (b) filing with the FDA of an IND application to conduct human clinical trials for drugs or biologics;
(c)