Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 100

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 100
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In order to compensate the patentee for delays
in obtaining a marketing authorization for a patented product, a supplementary certificate (“SPC”), may be granted extending
the exclusivity period for that specific product by up to five years. Applications for SPCs must be made to the relevant patent office
in each EU Member State and the granted certificates are valid only in the granting Member State. An application must be made by the patent
owner within six months of the first marketing authorization being granted in the European Union (assuming the patent in question has
not expired, lapsed or been revoked) or within six months of the grant of the patent (if the marketing authorization is granted first).
In the context of SPCs, the term “product” means the active ingredient or combination of active ingredients for a medicinal
product, and the term “patent” means a patent protecting such a product or a new manufacturing process or application for
it. The duration of an SPC is calculated as the difference between the patent’s filing date and the date of the first marketing
authorization, minus five years, subject to a maximum term of five years.

30

A six-month pediatric extension of an SPC may be
obtained where the patentee has carried out an agreed pediatric investigation plan, the authorized product information includes information
on the results of the studies and the product is authorized in all EU Member States.

Controlled Drugs Classification

The position in the member states of the European
Union is not harmonized. Member states have implemented the relevant United Nations Conventions (the Single Convention on Narcotic Drugs
1961 and the Convention on Psychotropic Substances 1971) into their national legislation, which has led to differences in how controlled
substances are regulated in different countries of the European Union. It is therefore important to determine at a national level whether
a substance is controlled and to comply with the applicable legal requirements.

Regulatory Requirements After Marketing Authorization

Following approval, the holder of the marketing
authorization is required to comply with a range of requirements applicable to the manufacturing, marketing, promotion and sale of the
medicinal product.

These include compliance with the European Union’s
stringent pharmacovigilance or safety reporting rules, pursuant to which post-authorization studies and additional monitoring obligations
can be imposed. The holder of a marketing authorization must establish and maintain a pharmacovigilance system and appoint an individual
qualified person for pharmacovigilance, who is responsible for oversight of that system.