Company: AEMD
Filing Date: 2025-06-26
Form Type: 10-K
Source: 0001683168-25-004780
Chunk: 216

Company: AETHLON MEDICAL INC
Filing Date: 2025-06-26
Form: 10-K
Item: Item 1A
Chunk 216
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 event of such an accident, we could be held liable for significant damages or fines.

We currently carry a limited
amount of insurance to protect us from bodily injury or property damages arising from hazardous materials. Our product liability policy
has a $5,000,000 limit of liability. For our facilities, our property policy provides $25,000 in coverage for contaminant clean-up or
removal and $100,000 in coverage for damages to the premises resulting from contamination. Should we violate any regulations concerning
the handling or use of hazardous materials, or should any injuries or death result from our use or handling of hazardous materials, we
could be the subject of substantial lawsuits by governmental agencies or individuals. We may not have adequate insurance to cover all
or any of such claims, if any. If we were responsible to pay significant damages for violations or injuries, if any, we might be forced
to cease operations since such payments could deplete our available resources.

Our products may in the future be subject
to product recalls. A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, including
a third-country authority, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.

The FDA and similar foreign
governmental authorities have the authority to require the recall of commercialized products in the event of material deficiencies or
defects in design or manufacture. For the FDA, the authority to require a recall must be based on a finding that there is reasonable probability
that the device would cause serious injury or death. In addition, foreign governmental bodies have the authority to require the recall
of our products in the event of material deficiencies or defects in design or manufacture. Manufacturers may, under their own initiative,
recall a product if any material deficiency in a device is found. The FDA requires that certain classifications of recalls be reported
to the FDA within ten working days after the recall is initiated. A government-mandated or voluntary recall by us or one of our international
distributors could occur as a result of an unacceptable risk to health, component failures, malfunctions, manufacturing errors, design
or labeling defects or other deficiencies and issues. Recalls of any of our products would divert managerial and financial resources and
have an adverse effect on our reputation, results of operations and financial condition, which could impair our ability to produce our
products in a cost-effective and timely manner in order to meet our customers’ demands. We may also be subject to liability