Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 109

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 109
---
 developers
need samples to conduct certain comparative testing required by the FDA, some have attributed the inability to timely obtain samples as
a cause of delay in the entry of generic and biosimilar products. To remedy this concern, the CREATES Act establishes a private cause
of action that permits a generic or biosimilar product developer to sue the brand manufacturer to compel it to furnish the necessary samples
on “commercially reasonable, market-based terms.” Although lawsuits have been filed under the CREATES Act since its enactment,
those lawsuits have settled privately; therefore, to date no federal court has reviewed or opined on the statutory language and there
continues to be uncertainty regarding the scope and application of the law.

35

More recently, in August 2022, President Biden
signed into the law the Inflation Reduction Act of 2022 (“IRA”). Among other things, the IRA has multiple provisions that
may impact the prices of drug products that are both sold into the Medicare program and throughout the United States. For example, a manufacturer
of a drug or biological product covered by Medicare Parts B or D must pay a rebate to the federal government if the drug product’s
price increases faster than the rate of inflation. This calculation is made on a drug product by drug product basis and the amount of
the rebate owed to the federal government is directly dependent on the volume of a drug product that is paid for by Medicare Parts B or
D. Additionally, starting in payment year 2026, CMS will negotiate drug prices annually for a select number of single source Part D drugs
without generic or biosimilar competition. CMS will also negotiate drug prices for a select number of Part B drugs starting for payment
year 2028. If a drug product is selected by CMS for negotiation, it is expected that the revenue generated from such drug will decrease.
CMS has begun to implement these new authorities and entered into the first set of agreements with pharmaceutical manufacturers to conduct
price negotiations in October 2023. However, the IRA’s impact on the pharmaceutical industry in the United States remains uncertain,
in part because multiple large pharmaceutical companies and other stakeholders (e.g., the U.S. Chamber of Commerce) have initiated federal
lawsuits against CMS arguing the program is unconstitutional for a variety of reasons, among other complaints. The outcome of such ongoing
lawsuits, as well as potential legislative changes enacted by Congress or programmatic changes implemented at CMS by the Trump administration,
may impact the IRA drug price negotiation program. For example, the One Big Beautiful Bill Act