Company: CSCIF
Filing Date: 2025-04-09
Form Type: 20-F
Source: 0001641172-25-003456
Chunk: 56

Company: COSCIENS Biopharma Inc.
Filing Date: 2025-04-09
Form: 20-F
Item: Item 5
Chunk 56
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  National procedure. If approval is sought independently in only one                                                                        

Similar to the U. S., the EMA provides incentivesfor the development of orphan drugs or for pediatrics. Orphan designation is granted for diseases affecting less than 5 in 10,000
people in the EU. With the designation, the sponsor benefits from prolonged market exclusivity (10 years) and fee reductions.

The pediatric regulation grants pediatric development
with a six-month extension of the supplementary protection certificate.

The EU marketing authorization is valid for five
years and is renewable upon application by the MAH. After the renewal the approval is permanently valid.

Regulation of Commercial Operations

The marketing, promotional, and pricing practices
of human pharmaceutical manufacturers, as well as the manner in which manufacturers interact with purchasers and prescribers, are subject
to various U. S. federal and state laws, including the federal anti-kickback statute and the False Claims Act, and state laws governing
kickbacks, false claims, unfair trade practices, and consumer protection, and to similar laws in other countries. In the U. S., these
laws are administered by, among others, the Department of Justice (“DOJ”), the Office of Inspector General of the
Department of Health and Human Services, the Federal Trade Commission, the Office of Personnel Management, and state attorneys general.
Over the past several years, the FDA, the DOJ and many other agencies have increased their enforcement activities with respect to pharmaceutical
companies and increased the inter-agency coordination of enforcement activities.

  39  

In the U. S., biopharmaceutical and medical device
manufacturers are required to record any transfers of value made to licensed physicians and teaching hospitals and to disclose such data
to the Department of Health and Human Services (“HHS”). In addition to civil penalties for failure to report transfers
of value to physicians or teaching hospitals, there will be criminal penalties if a manufacturer intentionally makes false statements
or excludes information in such reports. The payment data across biopharmaceutical and medical device companies is posted by the HHS
on a publicly available website. Increased access to such data by fraud and abuse investigators, industry critics and media will draw
attention to our collaborations with reported entities and will importantly provide opportunities to underscore the critical nature of
our collaborations for developing new medicines and exchanging scientific information. This national payment transparency effort coupled
with industry commitment to uphold voluntary codes of conduct (such as the PhR