Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2559

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2559
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 in, or shorten the duration of, the regulatory review and approval process.

European
Pediatric Investigation Plan

In
the EEA, companies developing a new medicinal product must agree upon a pediatric investigation plan, or PIP, with the EMA’s Pediatric
Committee, or PDCO, and must conduct pediatric clinical trials in accordance with that PIP, unless a waiver applies. The PIP sets out
the timing and measures proposed to generate data to support a pediatric indication of the drug for which marketing authorization is
being sought. The PDCO can grant a deferral of the obligation to implement some or all of the measures of the PIP until there are sufficient
data to demonstrate the efficacy and safety of the product in adults. Further, the obligation to provide pediatric clinical trial data
can be waived by the PDCO when this data is not needed or appropriate because the product is likely to be ineffective or unsafe in children,
the disease or condition for which the product is intended occurs only in adult populations, or when the product does not represent a
significant therapeutic benefit over existing treatments for pediatric patients. Products that are granted a marketing authorization
with the results of the pediatric clinical trials conducted in accordance with the PIP (even where such results are negative) are eligible
for six months’ supplementary protection certificate extension (if any is in effect at the time of approval). In the case of orphan
medicinal products, a two year extension of the orphan market exclusivity may be available. This pediatric reward is subject to specific
conditions and is not automatically available when data in compliance with the PIP are developed and submitted.

Brexit
and the Regulatory Framework in the United Kingdom

In
June 2016, the electorate in the UK voted in favor of leaving the EU (commonly referred to as Brexit). Thereafter, in March 2017, the
country formally notified the EU of its intention to withdraw pursuant to Article 50 of the Lisbon Treaty and the UK formally left the
EU on January 31, 2020. A transition period began on February 1, 2020, during which EU pharmaceutical law remained applicable to the
UK, which ended on December 31, 2020. Since the regulatory framework in the UK covering the quality, safety and efficacy of medicinal
products, clinical trials, marketing authorization, commercial sales and distribution of medicinal products is derived from EU Directives
and Regulations, Brexit could materially impact the future regulatory regime which applies to products and the approval