Company: APM
Filing Date: 2025-04-30
Form Type: 20-F
Source: 0001213900-25-037669
Chunk: 139

Company: Aptorum Group Ltd
Filing Date: 2025-04-30
Form: 20-F
Item: Item 4
Chunk 139
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 state laws targeting fraud and abuse in the healthcare industry. These laws
may impact, among other things, our proposed sales, marketing and education programs. In addition, we may be subject to patient privacy
regulation by both the federal government and the states in which we conduct our business.

Patient Protection and the Affordable Care
Act

The Affordable Care Act, enacted
in March 2010, includes measures that have or will significantly change the way health care is financed in the United States by both governmental
and private insurers. Among the provisions of the Affordable Care Act of greatest importance to the pharmaceutical industry are the following:

  The Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into and have in effect a national rebate agreement with the Secretary of the Department of Health and Human Serv...  

  In order for a pharmaceutical product to receive federal reimbursement under the Medicare Part B and Medicaid programs or to be sold directly to U. S. government agencies, the manufacturer must...  

  The Affordable Care Act imposed a requirement on manufacturers of branded drugs to provide a 50% discount off the negotiated price of branded drugs dispensed to Medicare Part D patients in the ...  

  The Affordable Care Act imposed an annual, non-deductible fee on any entity that manufactures or imports certain branded prescription drugs, apportioned among these entities according to their ...  

In addition to these provisions,
the Affordable Care Act established a number of bodies whose work may have a future impact on the market for certain pharmaceutical products.
These include the Patient-Centered Outcomes Research Institute, established to oversee, identify priorities in, and conduct comparative
clinical effectiveness research, the Independent Payment Advisory Board, which has authority to recommend certain changes to the Medicare
program to reduce expenditures by the program, and the Center for Medicare and Medicaid Innovation within the Centers for Medicare and
Medicaid Services, to test innovative payment and service delivery models to lower Medicare and Medicaid spending.

These and other laws may result
in additional reductions in healthcare funding, which could have a material adverse effect on customers for our product candidates, if
we gain approval for any of them. Although we cannot predict the full effect on our business of the implementation of existing legislation
or the enactment of additional legislation pursuant to healthcare and other legislative reform, we believe that legislation or regulations
that would reduce reimbursement for, or restrict coverage of, our products could adversely affect how much or under what circumstances
healthcare providers will use our product candidates if we gain approval for any of them.

Canadian Regulation

In Canada, our pharmaceutical