Company: CSCIF
Filing Date: 2025-04-09
Form Type: 20-F
Source: 0001641172-25-003456
Chunk: 59

Company: COSCIENS Biopharma Inc.
Filing Date: 2025-04-09
Form: 20-F
Item: Item 5
Chunk 59
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 regulations provide incentives to pharmaceutical
and biotechnology companies to develop and manufacture drugs for the treatment of rare diseases, currently defined as diseases that exist
in fewer than 200,000 individuals in the U. S., or diseases that affect more than 200,000 individuals in the U. S. but that the sponsor
does not realistically anticipate will generate a net profit. Under these provisions, a manufacturer of a designated orphan drug can
seek tax benefits, and the holder of the first FDA approval of a designated orphan product will be granted a seven-year period of marketing
exclusivity for such FDA-approved orphan product. In the U. S., the FDA has the authority to grant additional data protection for approved
drugs where the sponsor conducts specified testing in pediatric or adolescent populations. If granted, this pediatric exclusivity provides
an additional six months which are added to the term of data protection as well as to the term of any relevant patents, to the extent
these protections have not already expired. We may also seek to utilize market exclusivities in other territories, such as in the EU.
There can be no assurance that any of our drug candidates will obtain such orphan drug designation, pediatric exclusivity, a NCE exclusivity
or any other market exclusivity in the U. S., the EU or any other territory, or that we will be the first to receive the regulatory approval
in a given country or territory for such drugs so as to be eligible for any market exclusivity protection.

Macrilen™ (macimorelin):

We hold the worldwide rights to macimorelin pursuant
to an exclusive license agreement with the French Centre National de la Recherche Scientifique (CNRS), as licensor, and AEZS Germany,
as licensee. The obligation to pay royalties on net sales to CNRS expired in 2022. Macrilen™ is the approved trademark for macimorelin
as licensed under the License Agreement for commercialization in the U. S. and Canada.

The following patents and patent applications relate
to macimorelin:

  U. S. patent 8,192,719 covers a method of assessing pituitary-related                                                                   
  European patent EP3729100 covers the use of macimorelin to detect GHD                                                                   

  41  

  Japanese patent 4,852,728 covers a method of assessing pituitary-related                                                                  
  Based on the European patent 1,289,951 a request for supplementary                                                                        

An invention has been made by inventors of AEZ