Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3450

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3450
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 persons qualified to prescribe or supply them, no gifts, pecuniary advantages or
benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine
or pharmacy. This provision has been transposed into the Human Medicines Regulations 2012 and so remains applicable in the UK despite
its departure from the EU.

Payments
made to physicians in certain European Union Member States must be publicly disclosed. Moreover, agreements with physicians often must
be the subject of prior notification and approval by the physician’s employer, his or her competent professional organization and/or
the regulatory authorities of the individual EU Member States. These requirements are provided in the national laws, industry codes or
professional codes of conduct, applicable in the EU Member States. Failure to comply with these requirements could result in reputational
risk, public reprimands, administrative penalties, fines or imprisonment.

European
Drug Review and Approval

In
the European Economic Area, or EEA, which is comprised of the Member States of the European Union plus Norway, Iceland and Liechtenstein,
medicinal products can only be commercialized after obtaining a marketing authorization, or MA. There are two main types of marketing
authorizations.

61

    ●
    The
    centralized MA is issued by the European Commission through the centralized procedure, based on the opinion of the Committee for
    Medicinal Products for Human Use, or CHMP, of the EMA, and is valid throughout the entire territory of the EEA. The centralized procedure
    is mandatory for certain types of products, such as biotechnology medicinal products, orphan medicinal products, advanced-therapy
    medicinal products (gene-therapy, somatic cell-therapy or tissue-engineered medicines) and medicinal products containing a new active
    substance indicated for the treatment of HIV, AIDS, cancer, neurodegenerative disorders, diabetes, auto-immune and other immune dysfunctions
    and viral diseases. The centralized procedure is optional for products containing a new active substance not yet authorized in the
    EEA, or for products that constitute a significant therapeutic, scientific or technical innovation or which are in the interest of
    public health in the European Union. Under the centralized procedure the maximum timeframe for the evaluation of a MA application
    by the EMA 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. Clock stops may extend the timeframe