Company: CSCIF
Filing Date: 2025-04-09
Form Type: 20-F
Source: 0001641172-25-003456
Chunk: 54

Company: COSCIENS Biopharma Inc.
Filing Date: 2025-04-09
Form: 20-F
Item: Item 5
Chunk 54
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 the drug is
the first of its type approved for the specified indication, or if it demonstrates superior safety, efficacy, or a major contribution
to patient care versus another drug of its type that was previously granted the designation for the same indication. We have been granted
orphan drug designations for Macrilen™ (macimorelin) for the evaluation of GHD.

Under the Drug Price Competition and Patent Term
Restoration Act of 1984 (the “Hatch-Waxman Act”), newly approved drugs and indications may benefit from a statutory
period of non-patent data exclusivity. The Hatch-Waxman Act provides five-year data exclusivity to the first applicant to gain approval
of an NDA for a new chemical entity (“NCE”), meaning that the FDA has not previously approved any other drug containing
the same active pharmaceutical ingredient, or active moiety. Although protection under the Hatch-Waxman Act will not prevent the submission
or approval of another full NDA, such an NDA applicant would be required to conduct its own preclinical and adequate, well-controlled
clinical trials to demonstrate safety and effectiveness.

The Hatch-Waxman Act also provides three years of
data exclusivity for the approval of new and supplemental NDAs, including Section 505(b)(2) applications, for, among other things, new
indications, dosage forms, routes of administration, or strengths of an existing drug, or for a new use, if new clinical investigations
that were conducted or sponsored by the sponsor are determined by the FDA to be essential to the approval of the application. This exclusivity,
which is sometimes referred to as clinical investigation exclusivity, would not prevent the approval of another application if the sponsor
has conducted its own adequate, well-controlled clinical trials demonstrating safety and efficacy, nor would it prevent approval of a
generic product that did not incorporate the exclusivity-protected changes of the approved drug product.

The labeling, advertising, promotion, marketing,
and distribution of a drug or biologic product must be in compliance with FDA regulatory requirements. Failure to comply with applicable
requirements can lead to the FDA demanding that production and shipment cease and, in some cases, that the manufacturer recall products,
or to enforcement actions that can include seizures, injunctions, and criminal prosecution. These failures can also lead to FDA withdrawal
of approval to market a product. As long as the requirements are fulfilled and the fees are paid to FDA the product can stay on the market,
there is no renewal procedure.

Canada.