Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2548

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2548
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 transfers
of value to physicians and other healthcare providers or marketing expenditures.

57

In
order to distribute products commercially, we must comply with state laws that require the registration or licensure of manufacturers
and wholesale distributors of drug and biological products in a state, including, in certain states, manufacturers and distributors who
ship products into the state even if such manufacturers or distributors have no place of business within the state. Several states have
enacted legislation requiring pharmaceutical and biotechnology companies to establish marketing compliance programs, file periodic reports
with the state, make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities, and/or register
their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing
data to pharmaceutical and biotechnology companies for use in sales and marketing, and to prohibit certain other sales and marketing
practices. All of our activities are potentially subject to federal and state consumer protection and unfair competition laws.

The
scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform,
especially in light of the lack of applicable precedent and regulations. Federal and state enforcement bodies have recently increased
their scrutiny of interactions between healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions,
convictions and settlements in the healthcare industry. It is possible that governmental authorities will conclude that our business
practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare
laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that
may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, contractual
damages, reputational harm, diminished profits and future earnings, individual imprisonment, exclusion of drugs from government funded
healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations, any of which could adversely
affect our ability to operate our business and our financial results. If any of the physicians or other healthcare providers or entities
with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative
sanctions, including exclusions from government funded healthcare programs. Ensuring business arrangements comply with applicable healthcare
laws, as well as responding to possible investigations by government authorities, can be time- and resource-consuming and can divert
a company