Company: PETVW
Filing Date: 2025-08-14
Form Type: 10-Q
Source: 0001493152-25-011967
Chunk: 52

Company: PetVivo Holdings, Inc.
Filing Date: 2025-08-14
Form: 10-Q
Item: Part I, Item 2
Chunk 52
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 to distribute, advertise, promote, market, supply, and sell the Company’s lead product, Spryng®
on an exclusive basis for two (2) years within the United States (the “Territory”), transitioning to a non-exclusive basis
thereafter; provided however that the Company shall extend the exclusivity for an additional one (1) year if MWI achieves certain performance
targets agreed upon by the parties. The Company can continue to sell Spryng® within the Territory to established accounts,
which include: (a) customers who have purchased Spryng® from the Company prior to the date of the Agreement, (b) customers
who require that they deal directly with the Company, (c) governmental agencies, and (d) customers that order via the internet who are
not directly solicited by MWI to purchase Spryng®. All customers must be licensed veterinary practices.

Spryng®
is classified as a veterinary medical device under the United States Food and Drug Administration (“FDA”) rules and pre-market
approval is not required by the FDA. Spryng® completed a safety and efficacy study in rabbits in 2007. Since that time,
more than 2,000 horses and dogs have been treated with Spryng®. We entered into a clinical trial services agreement with
Colorado State University on November 5, 2020. We expect this university clinical study to be completed in March 2024. Additionally,
the Company successfully completed an equine tolerance study in March 2022 and began two canine clinical studies with Ethos Veterinary
Health, the first beginning in May of 2022 with anticipated completion in October 2023, and the second beginning in June of 2023 with
an expected completion in October 2024. We anticipate these and other studies that we plan to initiate will be primarily used to expand
our distribution outlets since the large international and national distributors generally require a third-party university study and
other third-party studies prior to including a product in their catalogue of products.

We
manufacture our products in an ISO 7 certified clean room manufacturing facility in Minneapolis using our patented and scalable self-assembly
production process, which minimizes the infrastructure requirements and manufacturing risks to deliver a consistent, high-quality product
while being responsive to volume requirements. A second ISO cleanroom facility is expected to be operational later this year. We believe
that having two manufacturing facilities will help us minimize supply risks, allow for continued scaling of our production capacity,
and expand