Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3454

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3454
---
 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 of product candidates
in the UK, as UK legislation now has the potential to diverge from EU legislation. It remains to be seen how Brexit will impact regulatory
requirements for product candidates and products in the UK in the long-term. The MHRA, the UK medicines and medical devices regulator,
has recently published detailed guidance for industry and organizations to follow from January 1, 2021 now the transition period is over,
which will be updated as the UK’s regulatory position on medicinal products evolves over time.

63

European
Data Collection

The
collection and use of personal health data in the European Economic Area, or the EEA, is governed by the GDPR, which became effective
May 25, 2018. The GDPR applies to any company established in the EEA and to