Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2650

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2650
---
 payors, including private insurers, and
    may be broader in scope than their federal equivalents; state and foreign laws that require biopharmaceutical companies to comply
    with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the
    federal government or otherwise restrict payments that may be made to healthcare providers and other potential referral sources;
    state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to
    physicians and other healthcare providers, marketing expenditures or drug pricing; state and local laws that require the registration
    of biopharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in
    certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating
    compliance efforts.

112

The
distribution of biopharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping,
licensing, storage and security requirements intended to prevent the unauthorized sale of biopharmaceutical products.

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. 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.

It
is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future
statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions
are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant
impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, fines, disgorgement,
imprisonment, reputational harm, possible exclusion from participation in federal and state funded healthcare programs, contractual damages
and the curtailment or restricting of our operations, as well as additional reporting obligations and oversight if we become subject
to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Further, if any of the
physicians or other healthcare providers or entities with whom we expect to do business are found to not be in compliance with applicable
laws, they may be subject to significant criminal, civil or administrative sanctions, including