Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2257

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2257
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 the U.K. Bribery Act 2010. 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, 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 supplier, offered or promised to such persons unless they are inexpensive and
relevant to the practice of medicine or pharmacy. Breach of this provision is an offence under the Human Medicines Regulations 2012,
which is the national implementing legislation of Directive 2001/83/EC in the U.K.

Payments
made to physicians in certain EU 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.

In
addition, in most foreign countries, including those in the European Economic Area, or EEA, the proposed pricing for a drug must be approved
before it may be lawfully marketed. The requirements governing drug pricing and reimbursement vary widely from country to country. For
example, the EU provides options for its member states to restrict the range of medicinal products for which their national health insurance
systems provide reimbursement and to control the prices of medicinal products for human use. Reference pricing used by various EU member
states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices. A member
state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability
of the company placing the medicinal product on the market. In some countries, we may be required to conduct a clinical trial or other
studies that compare the cost-effectiveness of any of our product candidates to other available therapies in order to obtain or maintain
reimbursement or pricing approval. There can be no assurance that any country that has price controls or reimbursement limitations for
biopharmaceutical products will allow favorable reimbursement and pricing arrangements for any of our products. Historically, products
launched in the EU do not follow price