Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 47

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 47
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  the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempt...  

  the federal civil monetary penalties laws, which impose civil fines for, among other things, the offering or transfer or remuneration to a Medicare or state healthcare program beneficiary if th...  

  the federal Physician Payments Sunshine Act, created under the Affordable Care Act, or the ACA, and its implementing regulations, which require manufacturers of drugs, devices, biologicals and ...  
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  federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;  

  federal price reporting laws, which require manufacturers to calculate and report complex pricing metrics to government programs, where such reported prices may be used in the calculation of re...  
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  analogous state and foreign laws and regulations, such as state and foreign anti-kickback, false claims, consumer protection and unfair competition laws which may apply to pharmaceutical busine...  
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Because of the breadth of these laws and the narrowness
of the statutory exceptions and regulatory safe harbors available, it is possible that some of our business activities could, despite
efforts to comply, be subject to challenge under one or more of such laws. Additionally, the FDA or foreign regulators may not agree that
we have mitigated any risk of bias in our clinical trials due to payments provided to investigators or institutions which could limit
a regulator’s acceptance of those clinical trial data in support of a marketing application. Moreover, efforts to ensure that our
business arrangements will comply with applicable healthcare laws may involve substantial costs.

It is possible that governmental and enforcement
authorities will conclude that such business practices may not comply with current or future statutes, regulations or case law interpreting
applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us and we are not successful
in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including