Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 98

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 98
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 stimulate innovation, optimize development and enable accelerated assessment
of PRIority MEdicines (“PRIME”). It is intended to build upon the scientific advice scheme and accelerated assessment procedure
offered by EMA. The program is voluntary and eligibility criteria must be met for a medicine to qualify for PRIME.

The PRIME scheme is open to medicines under development
and for which the applicant intends to apply for an initial marketing authorization application through the centralized procedure. Eligible
products must target conditions for which there is an unmet medical need (there is no satisfactory method of diagnosis, prevention or
treatment in the European Union or, if there is, the new medicine will bring a major therapeutic advantage) and they must demonstrate
the potential to address the unmet medical need by introducing new methods or therapy or improving existing ones. Applicants will typically
be at the exploratory clinical trial phase of development and will have preliminary clinical evidence in patients to demonstrate the promising
activity of the medicine and its potential to address to a significant extent an unmet medical need. In exceptional cases, applicants
from the academic sector or small and medium sized enterprises may submit an eligibility request at an earlier stage of development if
compelling nonclinical data in a relevant model provide early evidence of promising activity, and first in man studies indicate adequate
exposure for the desired pharmacotherapeutic effects and tolerability.

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If a medicine is selected for the PRIME scheme,
EMA:

●appoints a rapporteur from the CHMP or from the Committee for Advanced Therapies to provide continuous support and to build up knowledge
of the medicine in advance of the filing of a marketing authorization application;

●issues guidance on the applicant’s overall development plan and regulatory strategy;

●organizes a kick-off meeting with the rapporteur and experts from relevant EMA committees and working groups;

●provides a dedicated EMA contact person; and

●provides scientific advice at key development milestones, involving additional stakeholders, such as health technology assessment
bodies and patients, as needed.

Medicines that are selected for PRIME designation
are also expected to benefit from EMA’s accelerated assessment procedure at the time of application for marketing authorization.
Where, during the course of development, a medicine no longer meets the eligibility criteria, support under the PRIME scheme may be withdrawn.

Regulatory Data Protection in the European Union

In the EEA, innovative medicinal products approved
on the basis of a complete independent data package qualify for eight years of data exclusivity upon grant of a