Exclusivity. The Company may not, itself or with a third party, commercialize any molecule that inhibits, degrades or modulates menin or the interaction of menin and another protein in the Field other than ziftomenib in accordance with the Agreement. Kyowa Kirin may not, itself or with a third party, commercialize any molecule that inhibits, degrades or modulates menin or the interaction of menin and another protein other than ziftomenib in accordance with the Agreement. During the term of the Agreement, Kyowa Kirin may not, and may not grant a license or enable a third party, directly or indirectly, to, promote, sell or otherwise commercialize ziftomenib outside of the Field. In addition, during the term, the Company may not, and may not grant a license or enable a third party, directly or indirectly, to, clinically develop or commercialize ziftomenib outside of the Field in a manner that would reasonably be expected to result in off-label use in the Field, except that the foregoing restriction on Company will not apply to solid tumor indications if Kyowa Kirin does not exercise the Field Expansion Option.
Supply. The Company will be responsible for the manufacture and supply of ziftomenib for development and commercialization globally, pursuant to the terms of a supply agreement to be negotiated by the parties. Kyowa Kirin has the right to request the Company to conduct a manufacturing technology transfer and to take over the responsibility of commercial supply of ziftomenib outside the United States.
Financial Terms. The Company will receive an upfront payment of $330 million and is eligible to receive up to $420 million in near-term milestone payments, including a payment upon the launch of ziftomenib in the monotherapy relapsed/refractory (R/R) setting. In addition, the Company is eligible to receive additional development, regulatory and commercial milestone payments of $513 million for the existing Field (i.e., hematologic malignancies), and if Kyowa Kirin exercises the Field Expansion Option, the Company is eligible for upfront and milestone payments totaling $228 million for the expanded Field, totaling up to $1.491 billion in upfront and milestone payments in the aggregate. The Company is also eligible to receive tiered double-digit royalties on sales of ziftomenib outside of the United States on a country-by-country basis until the latest of expiration of the last-to-expire valid claim of the Company’s patent rights licensed to Kyowa Kirin in such country, expiration of the last-to-expire regulatory exclusivity in such country and ten years after first commercial sale in such country.
Termination. The Agreement will remain in effect in the United States until the latest of expiration of all valid claims of the Company’s patent rights licensed to Kyowa Kirin, expiration of the last-to-expire regulatory exclusivity or ten years after first commercial sale. The Agreement will remain in effect outside the United States until the expiration of the last-to-expire royalty term. Either party may terminate the Agreement for uncured material breach by or insolvency of the other party. Kyowa Kirin may terminate the Agreement for convenience upon twelve months’ prior written notice. In addition, Kyowa Kirin has the right to terminate the Agreement with a shorter specified notice period upon the occurrence of a material adverse regulatory event or certain other specified events. The Company may terminate the Agreement if Kyowa Kirin or any of its affiliates or sublicensees challenges the validity or enforceability of any of the patent rights licensed to Kyowa Kirin by the Company.
The foregoing description of the material terms of the Agreement is qualified in its entirety by reference to the full text of the Agreement, a copy of which will be filed as an exhibit to the Company’s annual report on Form 10-K for the year ending December 31, 2024 with the Securities and Exchange Commission (the “SEC”).
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the Company’s receipt of an upfront payment and potential receipt of an additional upfront payment, milestone payments and tiered double-digit royalties under the Agreement, Kyowa Kirin’s option under the Agreement and potential exercise thereof, the development plan under the Agreement and potential regulatory approval of ziftomenib in the United States. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “target,” “should,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including risks relating to the success of the collaboration and development of ziftomenib under the collaboration, Kyowa Kirin’s willingness to exercise its option, risks and uncertainties associated with the Company’s business and finances in general, and risks described under the caption “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024, which is on file with the SEC; and risks described in other filings that the Company makes with the SEC in the future. Any forward-looking statements contained in this Current Report on Form 8-K speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise.
