Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3553

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3553
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not yet known.

At
the state level, legislatures are increasingly passing legislation and implementing regulations designed to control biopharmaceutical
and biologic product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access
and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and
bulk purchasing.

These
laws, and future state and federal healthcare reform measures may be adopted in the future, any of which may result in additional reductions
in Medicare and other healthcare funding and otherwise affect the prices we may obtain for any of our product candidates for which we
may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used. Additionally, we expect
to experience pricing pressures in connection with the sale of any future approved product candidates due to the trend toward managed
healthcare, the increasing influence of health maintenance organizations, cost containment initiatives and additional legislative changes.

Inadequate
funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel,
prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from
performing normal business functions on which the operation of our business may rely, which could negatively impact our business.

The
ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding
levels, passage of federal FDA user fee legislation every five years, ability to hire and retain key personnel and accept the payment
of user fees, public health emergencies, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated
in recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations may rely,
including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.

Disruptions
at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies,
which would adversely affect our business. For example, over the last several years, the U.S. government has shut down several times,
and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical employees and stop critical activities. If
a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory
submissions, which could have a material adverse effect on our