Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 94

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 94
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 protecting the privacy of health and personal information and federal and state consumer protections laws
that regulate the collection, use, disclosure and transmission of personal information. These laws overlap and often conflict and each
of these laws is subject to varying interpretations by courts and government agencies, creating complex compliance issues. If we fail
to comply with applicable laws and regulations, we could be subject to penalties or sanctions, including criminal penalties. Our customers
and research partners must comply with laws governing the privacy and security of health information, including HIPAA and state health
information privacy laws. If we knowingly obtain health information that is protected under HIPAA, called “protected health information,”
our customers or research collaborators may be subject to enforcement, and we may have direct liability for the unlawful receipt of protected
health information or for aiding and abetting a HIPAA violation.

State laws protecting
health and personal information are becoming increasingly stringent. For example, the California Confidentiality of Medical Information
Act imposes restrictive requirements regulating the use and disclosure of health information and other personally identifiable information.
The California Consumer Privacy Act (“CCPA”) mirrors a number of the key provisions of the General Data Protection Regulation
(“GDPR”) described below. The CCPA establishes a new privacy framework for covered businesses by creating an expanded definition
of personal information, establishing new data privacy rights for consumers in the State of California, imposing special rules on the
collection of consumer data from minors, and creating a new and potentially severe statutory damages framework for violations of the CCPA
and for businesses that fail to implement reasonable security procedures and practices to prevent data breaches. The California Consumer
Rights Act (“CPRA”) became effective on January 1, 2023, strengthening elements of the CCPA. Since passage of the CCPA, several
other states (e.g., Connecticut, Colorado, Virginia, Delaware, Florida, Iowa, Montana, Oregon, Tennessee, Texas and Utah) have also enacted
comprehensive consumer privacy laws that include key differences from California’s law, further complicating compliance by industry
and other stakeholders. Other states in the United States are considering privacy laws similar to the CCPA.

International Regulation

In addition to regulations in the United States,
we are subject to a variety of international regulations governing clinical trials and the commercial sales and distribution of our drug
candidates. Whether or not we obtain FDA approval for a drug product, we must obtain approval of such product by the comparable regulatory
authorities of international countries before we can commence clinical trials or marketing of the product in those