Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2542

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2542
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 using
it or a method for manufacturing it may be extended. The patent-term restoration period is generally one-half the time between the effective
date of an IND and the submission date of an NDA or BLA plus the time between the submission date of an NDA or BLA and the approval of
that application, except that the review period is reduced by any time during which the applicant failed to exercise due diligence. Only
one patent applicable to an approved drug is eligible for the extension and the application for the extension must be submitted prior
to the expiration of the patent. The USPTO, in consultation with the FDA, reviews and approves the application for any patent term extension
or restoration. In the future, we may apply for restoration of patent term for our currently owned or licensed 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