Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3447

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3447
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HS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers
to plan sponsors under Medicare Part D, either directly or through pharmacy benefit managers, unless the price reduction is required
by law. The implementation of the rule has been delayed by the Infrastructure Investment and Jobs Act to January 2026. The rule also
creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a new safe harbor for certain fixed fee arrangements
between pharmacy benefit managers and manufacturers, the implementation of which have also been delayed. On November 20, 2020, CMS issued
an interim final rule implementing a new payment model, the Most Favored Nation Model, which would have tied Medicare Part B payments
for certain physician-administered drugs to the lowest price paid in other economically advanced countries, effective January 1, 2021.
On December 28, 2020, the United States District Court in Northern California issued a nationwide preliminary injunction against implementation
of the interim final rule. CMS withdrew the rule on December 27, 2021.

Packaging
and Distribution in the United States

If
our products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional
laws and requirements apply. Further, products must meet applicable child-resistant packaging requirements under the United States Poison
Prevention Packaging Act. Manufacturing, sales, promotion and other activities also are potentially subject to federal and state consumer
protection and unfair competition laws.

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

The
failure to comply with any of these laws or regulatory requirements subjects firms to possible legal or regulatory action. Depending
on the circumstances, failure to meet applicable regulatory requirements can result in significant penalties, including criminal prosecution,
fines, injunctions, exclusion from federal healthcare programs, requests for recall, seizure of products, total or partial suspension
of production, denial or withdrawal of product approvals, or refusal to allow a firm to enter into supply contracts, including government
contracts. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant
legal expenses and divert our management’s attention from the operation of our business. Prohibitions or restrictions on sales
or withdrawal of future products marketed by us could materially affect our business in an adverse way.

Changes
in regulations, statutes or