Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 157

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 157
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 generic or biosimilar applicants from
relying on the preclinical and clinical trial data contained in the dossier of the reference product when applying for a generic or biosimilar
marketing authorization in the European Union during a period of eight years from the date on which the reference product was first authorized
in the European Union. The market exclusivity period prevents a successful generic or biosimilar applicant from commercializing its product
in the European Union until 10 years have elapsed from the initial authorization of the reference product in the European Union. The 10-year
market exclusivity period can be extended to a maximum of eleven 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 their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.

Orphan drug designation. In the EEA, a medicinal
product can be designated as an orphan drug if its sponsor can establish that the product is intended for the diagnosis, prevention or
treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10,000 persons in the European Union
when the application is made, or that the product is intended for the diagnosis, prevention or treatment of a life-threatening, seriously
debilitating or serious and chronic condition in the European Community and that without incentives it is unlikely that the marketing
of the drug in the European Union would generate sufficient return to justify the necessary investment. For either of these conditions,
the applicant must demonstrate that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question
that has been authorized in the European Union or, if such method exists, the drug will be of significant benefit to those affected by
that condition.

In the EEA, an application for designation as an
orphan product can be made any time prior to the filing of an application for approval to market the product. Marketing authorization
for an orphan drug leads to a ten-year period of market exclusivity. During this market exclusivity period, the EMA or the competent authorities
of the Member States, cannot accept another application for a marketing authorization, or grant a marketing authorization, for a similar
medicinal product for the same indication. The period of market exclusivity is extended by two years for orphan medicinal products that
have also complied with an agreed pediatric investigation plan.

This period of orphan market exclusivity may, however,
be reduced to six years if, at the