Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2143

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2143
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 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’s attention from the business.

Current
and Future Legislation

In
the United States and some foreign jurisdictions, there have been, and likely will continue to be, a number of legislative and regulatory
changes and proposed changes regarding the healthcare system directed at broadening the availability of healthcare, improving the quality
of healthcare, and containing or lowering the cost of healthcare.

For
example, in March 2010, the ACA was enacted in the United States. The ACA includes measures that have significantly changed, and are
expected to continue to significantly change, the way healthcare is financed by both governmental and private insurers. Among the provisions
of the ACA of greatest importance to the pharmaceutical industry are that the ACA:

    ●
    made
    several changes to the Medicaid Drug Rebate Program, including