Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2555

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2555
---

assessment of clinical trial applications.

European
Drug Marketing

Much
like the Anti-Kickback Statue prohibition in the United States, the provision of benefits or advantages to physicians to induce or encourage
the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is also prohibited in the European
Union. The provision of benefits or advantages to induce or reward improper performance generally is usually governed by the national
anti-bribery laws of European Union Member States, and the Bribery Act 2010 in the UK. Infringement of these laws could result in substantial
fines and imprisonment. EU Directive 2001/83/EC, which is the EU Directive governing medicinal products for human use, further provides
that, where medicinal products are being promoted to 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