Company: WHWK
Filing Date: 2025-01-31
Form Type: DEFM14A
Source: 0001193125-25-018470
Chunk: 290

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-31
Form: DEFM14A
Chunk 290
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 31, 2024, we
licensed seven (7) issued U.S. patents with composition of matter and method of use claims covering FYARRO. The first issued U.S. patent is set to expire in 2029, subject to patent term extension, and the other four are expected to expire in
2030, 2036, 2036, 2036, 2036 and 2040, respectively. In addition, we licensed related patents and patent applications in Europe, Australia, North America, South America, and Asia that are expected to expire between 2026 and 2040. We also own or
licensed many pending U.S. applications and related pending applications in Europe, Australia, North America, South America, Africa, and Asia.

The term
of individual patents depends upon the legal term of the patents in the countries in which they are obtained. In most countries in which we file, the patent term is 20 years from the earliest date of filing a
non-provisional patent application.

In the United States, the term of a patent covering an FDA approved drug may,
in certain cases, be eligible for a patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the Hatch-Waxman Act, as compensation for the loss of patent term during FDA regulatory
review process. The period of extension may be up to five years but cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval. Only one patent among those eligible for an extension and only those
claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended. Similar provisions are available in Europe and in certain other jurisdictions to extend the term of a patent that covers an approved drug. In
January 2022, we filed an application for patent term extension based on the approval of FYARRO. We also intend to seek patent term extensions in any jurisdictions where they are available, however, there is no guarantee that the applicable
authorities, including the FDA, will agree with our assessment of whether such extensions should be granted, and even if granted, the length of such extensions.

In addition to patent protection, we also rely on trade secret protection for our proprietary information that is not amenable to, or that we do not consider
appropriate for, patent protection, including, for example, certain aspects

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of our manufacturing processes for the nanoparticle compositions