Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 111

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 111
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 or member state level may result in significant additional requirements or obstacles that may increase our operating costs. The
delivery of healthcare in the European Union, including the establishment and operation of health services and the pricing and reimbursement
of medicines, is almost exclusively a matter for national, rather than European Union, law and policy. National governments and health
service providers have different priorities and approaches to the delivery of healthcare and the pricing and reimbursement of products
in that context. In general, however, the healthcare budgetary constraints in most member states and the United Kingdom have resulted
in restrictions on the pricing and reimbursement of medicines by relevant health service providers. Coupled with increasing regulatory
burdens on those wishing to develop and market products, this could prevent or delay marketing approval of our drug candidates, restrict
or regulate post-approval activities and affect our ability to commercialize any products for which we obtain marketing approval. In international
markets, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings
on specific products and therapies.

36

We
cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or
executive action, either in the United States or abroad. We expect that additional state and federal healthcare reform measures will
be adopted in the future, any of which could limit the amounts that federal and state governments will pay for healthcare products and
services, including prescription pharmaceuticals.

Environmental, Health and Safety Regulation

We are subject to numerous
federal, state and local environmental, health and safety (“EHS”) laws and regulations relating to, among other matters, safe
working conditions, product stewardship, environmental protection, and handling or disposition of products, including those governing
the generation, storage, handling, use, transportation, release, and disposal of hazardous or potentially hazardous materials, medical
waste, and infectious materials that may be handled by our partner research laboratories. Some of these laws and regulations also require
us to obtain licenses or permits to conduct our operations. If we fail to comply with such laws or obtain and comply with the applicable
permits, we could face substantial fines or possible revocation of our permits or limitations on our ability to conduct our operations.
Certain of our development and manufacturing activities may involve, from time to time, use of hazardous materials, and we believe we
are in compliance with the applicable environmental laws, regulations, permits, and licenses. However, we cannot ensure that EHS liabilities
will not develop in the future. E