Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2137

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2137
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 patents to add patent
life beyond its current expiration date, depending on the expected length of the clinical trials and other factors involved in the filing
of the relevant NDA or BLA.

Marketing
exclusivity provisions under the FD&C Act also can delay the submission or the approval of certain applications. The FD&C Act
provides a five-year period of non-patent marketing exclusivity within the United States to the first applicant to gain approval of an
NDA for a new chemical entity. A drug is a new chemical entity if the FDA has not previously approved any other new drug containing the
same active moiety, which is the molecule or ion responsible for the action of the drug substance. During the exclusivity period, the
FDA may not accept for review an ANDA, or a 505(b)(2) NDA submitted by another company for another version of such drug where the applicant
does not own or have a legal right of reference to all the data required for approval. However, an application may be submitted after
four years if it contains a certification of patent invalidity or non-infringement. The FD&C Act also provides three years of marketing
exclusivity for an NDA, 505(b)(2) NDA or supplement to an existing NDA if new clinical investigations, other than bioavailability studies,
that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval of the application, for example,
new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only the conditions of use associated with
the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs containing the original active agent. Five-year
and three-year exclusivity will not delay the submission or approval of a full NDA. However, an applicant submitting a full NDA would
be required to conduct or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials
necessary to demonstrate safety and effectiveness.

Biosimilars
and Exclusivity

Certain
of our product candidates will be regulated as biologics. An abbreviated approval pathway for biological products shown to be similar
to, or interchangeable with, an FDA-licensed reference biological product was created by the Biologics Price Competition and Innovation
Act of 2009, or BPCI Act, as part of the Affordable Care Act, or ACA. This amendment to the PHSA, in part, attempts to minimize duplicative