Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 155

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 155
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 and state fraud and abuse and other healthcare laws and regulations that may constrain the
business or financial arrangements and relationships through which we market, sell and distribute any products for which we obtain marketing
approval. Restrictions under applicable healthcare laws and regulations include the following:

The Anti-Kickback Statute prohibits, among other
things, persons from knowingly and willfully soliciting, offering, receiving or providing any remuneration, directly or indirectly, in
cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation
of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid;

The False Claims Act imposes criminal and civil
penalties against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for
payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the Federal
governments; and

HIPAA imposes criminal and civil liability for
executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. HIPAA, as amended
by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also imposes obligations,
including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable
health information.

The Physician Payments Sunshine Act requires applicable
manufacturers of covered drugs to report payments and other transfers of value to physicians, certain advanced non-physician healthcare
practitioners, and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family, which
includes data collection and reporting obligations. Such information reported to CMS is made publicly available on a searchable website.

Analogous state and international laws and regulations,
such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items
or services reimbursed by non-governmental third-party payors, including private insurers. Some state laws require pharmaceutical companies
to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by
the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians
and other healthcare providers or marketing expenditures. State and international laws also govern the privacy and security of health
information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIP