Company: CERO
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001213900-25-032134
Chunk: 145

Company: CERO THERAPEUTICS HOLDINGS, INC.
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1
Chunk 145
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 profitable not to justify maintenance of market exclusivity.
Additionally, an MA may be granted to a similar medicinal product for the same indication as an authorized orphan product at any time
if:

●the second applicant can establish that its product, although similar to the authorized orphan product,
is safer, more effective or otherwise clinically superior;

●the MA holder of the authorized orphan product consents to a second medicinal product application; or

●the MA holder of the authorized product cannot supply enough orphan medicinal product.

A pediatric investigation
plan (“PIP”) in the European Union is aimed at ensuring that the necessary data are obtained to support the authorization
of a medicine for children, through studies in children. All applications for MAs for new medicines have to include the results of studies
as described in an agreed PIP, unless the medicine is exempt because of a deferral or waiver. This requirement also applies when an MA
holder wants to add a new indication, pharmaceutical form, or route of administration for a medicine that is already authorized and covered
by intellectual property rights. Several rewards and incentives for the development of pediatric medicines for children are available
in the European Union. Medicines authorized across the European Union with the results of studies from a PIP included in the product information
are eligible for an extension of their supplementary protection certificate (“SPC”) by six months (provided an application
for such extension is made at the same time as filing the SPC application for the product, or at any point up to two years before the
SPC expires). This is the case even when the studies’ results are negative. For orphan medicinal products, the incentive is an additional
two years of market exclusivity. Scientific advice and protocol assistance at the EMA are free of charge for questions relating to the
development of pediatric medicines. Medicines developed specifically for children that are already authorized but are not protected by
a patent or supplementary protection certificate are eligible for a pediatric-use MA (“PUMA”). If a PUMA is granted, the product
will benefit from ten years of market protection as an incentive.

31

In March 2016, the EMA launched
an initiative, the PRIority MEdicines (“PRIME”) scheme, to facilitate development of product candidates in indications, often
rare, for which few or no therapies currently exist. The PRIME scheme is intended to encourage development of products in areas of unmet
medical need and provides accelerated assessment of products representing substantial innovation reviewed under the centralized procedure.
Products from