Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 99

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 99
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 marketing authorization
and an additional two years of market exclusivity pursuant to Regulation (EC) No. 726/2004, as amended, and Directive 2001/83/EC, as amended.
Data exclusivity prevents generic and biosimilar applicants from referencing the innovator’s preclinical and clinical trial data
contained in the dossier of the reference product when applying for a marketing authorization for a period of eight years from the date
on which the reference product was first authorized in the EEA. During the additional two-year period of market exclusivity, a generic
or biosimilar marketing authorization application can be submitted, and the innovator’s data may be referenced, but no generic or
biosimilar medicinal product can be marketed until the expiration of the market exclusivity period. The overall 10-year period will be
extended to a maximum of 11 years if, during the first eight years of those 10 years, the marketing authorization holder obtains an authorization
for one or more new therapeutic indications which, during the scientific evaluation prior to authorization, is held to bring a significant
clinical benefit in comparison with existing therapies. Even if a compound is considered to be an innovative medicinal product so that
the innovator gains the prescribed period of data exclusivity, another company may market another version of the product if such company
obtained marketing authorization based on a MAA with a completely independent data package of pharmaceutical tests, preclinical tests
and clinical trials.

Periods of Authorization and Renewals

A marketing authorization is valid for five years,
in principle, and it may be renewed after five years on the basis of a re-evaluation of the risk benefit balance by the EMA or by the
competent authority of the authorizing Member State. To that end, the marketing authorization holder must provide the EMA or the competent
authority with a consolidated version of the file in respect of quality, safety and efficacy, including all variations introduced since
the marketing authorization was granted, at least nine months before the marketing authorization ceases to be valid. Once renewed, the
marketing authorization is valid for an unlimited period, unless the European Commission or the competent authority decides on justified
grounds relating to pharmacovigilance, to proceed with one additional five-year renewal period. Any authorization that is not followed
by the placement of the product on the EEA market (in the case of the centralized procedure) or on the market of the authorizing member
state within three years after authorization ceases to be valid.

Patent Term Extension