Company: AEMD
Filing Date: 2025-09-05
Form Type: 424B4
Source: 0001683168-25-006701
Chunk: 27

Company: AETHLON MEDICAL INC
Filing Date: 2025-09-05
Form: 424B4
Chunk 27
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defined to include doctors,
dentists, optometrists, podiatrists and chiropractors) and other healthcare professionals (such as physicians assistants and nurse practitioners)
and teaching hospitals. Many states have similar laws and regulations that may differ from each other and federal law in significant
ways, thus complicating compliance efforts. For example, states have anti-kickback and false claims laws that may be broader in scope
than analogous federal laws and may apply regardless of payor. In addition, state data privacy laws that protect the security of health
information may differ from each other and may not be preempted by federal law. Moreover, several states have enacted legislation requiring
pharmaceutical manufacturers to, among other things, establish marketing compliance programs, file periodic reports with the state, make
periodic public disclosures on sales and marketing activities, report information related to drug pricing, require the registration of
sales representatives, and prohibit certain other sales and marketing practices. These laws may adversely affect our sales, marketing
and other activities with respect to any product candidate for which we receive approval to market in the United States by imposing administrative
and compliance burdens on us.

Because of the breadth of these
laws and the narrowness of available statutory exceptions and regulatory safe harbors, it is possible that some of our business activities,
particularly any sales and marketing activities after a product candidate has been approved for marketing in the United States, could
be subject to legal challenge and enforcement actions. If our operations are found to be in violation of any of the federal and state
laws described above or any other governmental regulations that apply to us, we may be subject to significant civil, criminal, and administrative
penalties, including, without limitation, damages, fines, imprisonment, exclusion from participation in government healthcare programs,
additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve
allegations of non-compliance with these laws, and the curtailment or restructuring of our operations, any of which could adversely affect
our ability to operate our business and our results of operations.

From time to time, legislation
is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture
and marketing of regulated products or the reimbursement thereof. For example, in the United States, the Patient Protection and Affordable
Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively, ACA, among other things, reduced and/or
limited Medicare reimbursement to certain providers and imposed