Company: PETVW
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001641172-25-018617
Chunk: 28

Company: PetVivo Holdings, Inc.
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 28
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 management.

We
must respect prevailing third-party intellectual property, and the procedures and steps we take to prevent our misappropriation, infringement,
or other violation of the intellectual property of others may not be successful. If third parties assert infringement claims against
us, our suppliers, or veterinarians using our products and technology, we could be required to expend substantial financial and personnel
resources to respond to and litigate or settle any such third-party claims. Although we believe our patents, manufacturing processes
and products do not infringe in any material respect on the intellectual property rights of other parties, we could be found to infringe
on such proprietary rights of others. Any claims that our products, processes, or technology infringe on third-party rights, regardless
of their merit or resolution could be very costly to us and also materially divert the efforts and attention of our management and technical
personnel. Any adverse outcome to us from one or more such claims against us could, among other things, require us to pay substantial
damages, to cease the sale of our products, to discontinue our use of any infringing processes or technology, to expend substantial resources
to develop non-infringing products or technology, or to license technology from the infringed party. If one or more of such adverse outcomes
occur, our ability to compete could be affected significantly and our business, financial condition and results of operations could be
harmed substantially.

Risks
related to Regulation

We
may be unable to obtain required regulatory approvals for future products timely or at all, and the denial or substantial delay of any
such approval could delay materially or even prevent our efforts to commercialize new products, which could adversely impact our ability
to generate future revenues.

Based
on our determination that our Spryng® products is a device for the treatment of animals rather than being a pharmaceutical
product, we believe we are not required to obtain regulatory approval to produce and market them for their current intended uses. However,
we have not received confirmation from any regulatory authority that our determination is correct. The production, marketing, and sale
of any future products for the treatment of animals based on our proprietary technology may require us to obtain regulatory approval
from the Center for Veterinarian Medicine (“CVM”), a branch of the FDA, and/or the USDA, and also certain state regulatory
authorities. Any substantial delay or inability to obtain required regulatory approvals for any new products developed by us could substantially
delay or even prevent their commercialization, which would materially