Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2662

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2662
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 take considerable time after obtaining marketing approval of a product candidate. In addition, market acceptance and
sales of our product candidates will depend significantly on the availability of adequate coverage and reimbursement from third-party
payors for our product candidates and may be affected by existing and future health care reform measures.

Much
like the federal Anti-Kickback Statute 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 EU. The provision of benefits or advantages to induce or reward improper performance generally is governed by the national anti-bribery
laws of EU Member States, and in respect of the U.K. (which is longer a member of the EU), 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