Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 50

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 50
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ible. This preference for U.S. industry may limit our ability to contract with non-U.S. product manufacturers for products relating
to such intellectual property. To the extent any of our future intellectual property is also generated through the use of U.S. government
funding, the provisions of the Bayh-Dole Act may similarly apply.

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Patent terms may be inadequate to establish our competitive position on our drug candidates for an adequate amount of time.

Patents have a limited lifespan. In the United
States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional
filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents
directed to our drug candidates are obtained, once the patent life has expired for a drug candidate, we may be open to competition from
competitive medications, including generic versions. Given the amount of time required for the development, testing and regulatory review
of new drug candidates, patents directed towards such drug candidates might expire before or shortly after such drug candidates are commercialized.
As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing
drug candidates similar or identical to ours for a meaningful amount of time, or at all.

Depending upon the timing, duration and conditions
of any FDA marketing approval of our drug candidates, one or more of our owned or licensed U.S. patents may be eligible for limited patent
term extension under the Hatch-Waxman Act, and similar legislation in the EU and certain other countries. The Hatch-Waxman Act permits
a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during
product development and the FDA regulatory review process. However, we may not receive an extension if we fail to exercise due diligence
during the testing phase or regulatory review process, fail to apply within applicable deadlines, fail to apply prior to expiration of
relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request.
Only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years from approval
and only those claims for the approved drug, a method for using it or a method for manufacturing it may be extended. If we are unable
to obtain patent term