Company: CERO
Filing Date: 2025-02-07
Form Type: 424B3
Source: 0001213900-25-011071
Chunk: 197

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-02-07
Form: 424B3
Chunk 197
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 be called upon
for this purpose), they are sent to the CHMP, whose comments or objections are communicated to the applicant. The rapporteur is therefore
the privileged interlocutor of the applicant and continues to play this role, even after the MA has been granted.

The rapporteur and co-rapporteur
then assess the applicant’s replies, submit them for discussion to the CHMP, and taking into account the conclusions of this debate,
prepare a final assessment report. Once the evaluation is completed, the CHMP gives a favorable or unfavorable opinion as to whether
to grant the authorization. When the opinion is favorable, it shall include the draft summary of product characteristics (“SmPC”),
the package leaflet, and the texts proposed for the various packaging materials. The time limit for the evaluation procedure is 210 days
(excluding clock stops, when additional written or oral information is to be provided by the applicant in response to questions asked
by the CHMP). The EMA then has fifteen days to forward its opinion to the European Commission, which will make a binding decision
on the grant of an MA within 67 days of the receipt of the CHMP opinion.

National marketing authorizations,
which are issued by the competent authorities of the Member States of the European Union and only cover their respective territory, are
available for products not falling within the mandatory scope of the centralized procedure. Where a product has already been authorized
for marketing in a Member State of the European Union, this national authorization can be recognized in other Member States through the
mutual recognition procedure. If the product has not received a national authorization in any Member State at the time of application,
it can be approved simultaneously in various Member States through the decentralized procedure.

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In the European Union, new
chemical entities (including both small molecules and biological medicinal products) approved on the basis of a complete and independent
data package qualify for eight years of data exclusivity upon marketing authorization and an additional two years of market exclusivity.
Data exclusivity, if granted, prevents generic or biosimilar applicants from referencing the innovator’s pre-clinical and clinical
trial data contained in the dossier of the reference product when applying for a generic or biosimilar MA, for a period of eight years
from the date on which the reference product was first authorized in the European Union. During the additional two-year period of market
exclusivity, a generic or biosimilar MAA can be submitted, and the innovator’s data