Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 163

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 163
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 scrutiny over the manner in which manufacturers
set prices for their marketed products, which has resulted in several Congressional inquiries, proposed and enacted legislation designed
to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs,
and reform government program reimbursement methodologies for drug products. The likelihood of implementation of any of these reform initiatives
is uncertain, particularly in light of the new presidential administration. Individual states in the United States have also become increasingly
active in implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints,
discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed
to encourage importation from other countries and bulk purchasing.

Environmental, Health and Safety

We are also subject to numerous environmental,
health and safety laws and regulations, including those governing laboratory procedures, the generation, handling, use, storage, treatment,
release and disposal of, and exposure to, hazardous materials and wastes and worker health and safety. Our operations involve the use
of hazardous and flammable materials, including chemicals and biological materials, and produce hazardous waste products and the risk
of injury, contamination or non-compliance with environmental, health and safety laws and regulations cannot be eliminated. Environmental,
health and safety laws and regulations are complex, change frequently and have tended to become more stringent, and we may incur substantial
costs in order to comply with such current or future laws and regulations.

Data Privacy and Security Laws

Numerous state, federal and foreign laws, including
consumer protection laws and regulations, govern the collection, dissemination, use, access to, confidentiality and security of personal
information, including health-related information. In the United States, federal and state laws and regulations, including data breach
notification laws, health information privacy laws, and federal and state consumer protection laws and regulations (e. g., Section 5 of
the Federal Trade Commission Act, or the FTC Act), that govern the collection, use, disclosure, and protection of health-related and other
personal information could apply to our operations or the operations of our partners. For example, HIPAA, as amended by HITECH imposes
privacy, security and breach notification obligations on certain health care providers, health plans, and health care clearinghouses,
known as covered entities, as well as their business associates that perform certain services that involve creating, receiving, maintaining
or transmitting individually identifiable health information for or on behalf of such covered entities. Entities that are found to be
in violation