Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 46

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 3
Chunk 46
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 product candidates. We may be required to obtain coverage and reimbursement for these tests separate and apart
from the coverage and reimbursement we seek for our product candidates, once approved. Even if we obtain regulatory approval for such
companion diagnostics, there is significant uncertainty regarding our ability to obtain coverage and adequate reimbursement for the same
reasons applicable to our product candidates. Medicare reimbursement methodologies, whether under Part A, Part B, or clinical laboratory
fee schedule may be amended from time to time, and we cannot predict what effect any change to these methodologies would have on any product
candidate or companion diagnostic for which we receive approval.

If we fail to comply with healthcare laws, we could face substantial
penalties and our business, financial condition and results of operations could be adversely affected.

Healthcare providers, physicians and third-party
payors in the United States and elsewhere play a primary role in the recommendation and prescription of pharmaceutical products. Arrangements
with healthcare providers, third-party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse
and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which such
companies sell, market and distribute pharmaceutical products. In particular, the promotion, sales and marketing of healthcare items and
services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud,
kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of ownership, pricing,
discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements
generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment
for clinical trials. The applicable federal and state healthcare laws and regulations laws that may affect our ability to operate include,
but are not limited to:

  the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, ...  
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  federal civil and criminal false claims laws, including the False Claims Act, or FCA, which impose criminal and civil penalties, including through civil “qui tam” or “whistleblower” actions, ag...  
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