Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 47

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 47
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quired or licensed or may acquire or license in the future may have been generated through the use of U.S. government funding and may
therefore be subject to certain federal regulations. These U.S. government rights include a non-exclusive, non-transferable, irrevocable
worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right, under certain limited
circumstances, to require us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third
party if it determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is necessary
to meet public health or safety needs; or (iii) government action is necessary to meet requirements for public use under federal regulations
(also referred to as “march-in rights”). The U.S. government also has the right to take title to these inventions if the grant
recipient fails to disclose the invention to the government or fails to file an application to register the intellectual property within
specified time limits. Intellectual property generated under a government funded program is also subject to certain reporting requirements,
compliance with which may require us to expend substantial resources. In addition, the U.S. government requires that any products embodying
any of these inventions or produced through the use of any of these inventions be manufactured substantially in the United States. This
preference for U.S. industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual
property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that
would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially
feasible. 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