Company: APM
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001213900-25-111548
Chunk: 228

Company: Aptorum Group Ltd
Filing Date: 2025-11-17
Form: F-1
Chunk 228
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 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 Services as a condition 
 for states to receive federal matching funds for the manufacturer’s outpatient drugs furnished to Medicaid patients. The Affordable           
 Care Act increased pharmaceutical manufacturers’ rebate liability on most branded prescription drugs from 15.1% of the average                
 manufacturer price to 23.1% of the average manufacturer price, added a new rebate calculation for line extensions of solid oral dosage        
 forms of branded products, and modified the statutory definition of average manufacturer price. The Affordable Care Act also expanded         
 the universe of Medicaid utilization subject to drug rebates by requiring pharmaceutical manufacturers to pay rebates on Medicaid managed     
 care utilization and expanding the population potentially eligible for Medicaid drug benefits.                                                |

| ● | 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 extend       
 discounts to entities eligible to participate in the 340B drug pricing program. The Affordable Care Act expanded the types of entities 
 eligible to receive discounted 340B pricing.                                                                                           |

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 coverage gap (i.e., the “donut hole”).

| ● | 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     
 market share in certain government healthcare programs, although this fee does not apply to sales of certain products approved exclusively 
 for orphan indications.                                                                                                                    |

134 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