Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 89

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 89
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 |     | 14/886,738         |     |        |  9,994,608 |   |     | 6/5/2029             |
| Treatment Methods Using Pharmaceutical Solid State Forms                    |     | 14/459,493         |     |        |  9,877,972 |   |     | 4/3/2029             |
| Compositions for Treatment of Neurodegenerative Conditions                  |     | 18/511,027         |     |        |    pending |   |     | —                    |
| Methods For the Treatment of Biological Aging                               |     | 19/190210          |     |        |    pending |   |     | —                    |
| Methods For the Treatment of Mild Cognitive Impairment                      |     | 19/055380          |     |        |    pending |   |     | —                    |
| Neurosteroid Compounds and Uses of the Same                                 |     | 63/717,574         |     |        |    pending |   |     | —                    |

| * | Foreign counterparts issued in Australia, Canada, Europe and South 
 Korea projected to expire 4/3/2029.                                |

Government Regulation

Government authorities in the United States, at
the federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing,
manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval
monitoring and reporting, marketing and export and import of products such as those we are developing. Any pharmaceutical candidate that
we develop must be approved by the FDA before it may be legally marketed in the United States and by the appropriate foreign regulatory
agency before it may be legally marketed in foreign countries.

United States Drug Development Process

In the United States, the FDA regulates drugs
under the Federal Food, Drug and Cosmetic Act (“FDCA”), and implements regulations. Drugs are also subject to other federal,
state and local statutes and regulations. Biologics are subject to regulation by the FDA under the FDCA, the Public Health Service Act
(the “PHSA”), and related regulations, and other federal, state and local statutes and regulations. Biological products include,
among other things, viruses, therapeutic serums, vaccines and most protein products. The process of obtaining regulatory approvals and
the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require