| Item 2.01 | Completion of Acquisition or Disposition of Assets. |
Effectiveness of License Agreement
As previously disclosed, on August 8, 2021, Seagen Inc. (the “Company”) entered into a License Agreement (the “Agreement”) with RemeGen Co., Ltd. (“RemeGen”). The effectiveness of the Agreement was subject to all relevant antitrust clearances or non-actions being granted and the expiration or termination of all applicable waiting periods under any antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. On September 15, 2021 (the “Effective Date”), the Agreement became effective.
Pursuant to the Agreement, the Company was granted an exclusive license to research, develop and commercialize the HER2-targeted antibody-drug conjugate (ADC) product known as disitamab vedotin (RC48) in all countries of the world other than the countries retained as the RemeGen Territory (as defined below) (the “Company Territory”). RemeGen retained the right to research, develop and commercialize disitamab vedotin in Asia, excluding Japan & Singapore (the “RemeGen Territory”). RemeGen also granted the Company the right to research, develop and commercialize new licensed products that are ADCs containing disitamab and the Company’s proprietary drug-linkers, subject to RemeGen’s right to opt-in and obtain the right to develop and commercialize such new licensed products in the RemeGen Territory. The parties may collaborate on global trials for disitamab vedotin and new licensed products for which RemeGen has exercised its opt-in right.
Pursuant to the Agreement, in consideration of the rights it received, the Company will pay RemeGen an upfront, non-refundable cash payment of $200 million within 30 days of the Effective Date. RemeGen is eligible to receive up to $2.4 billion in potential total milestone payments based upon the achievement of specified development, regulatory and commercialization goals across multiple indications and products. RemeGen is eligible to receive tiered royalties at percentages ranging from the high single digits to mid-teens on future cumulative net sales by the Company of disitamab vedotin in the Company Territory. Royalties payable under the Agreement are subject to standard royalty reductions.
The Agreement will remain in effect, unless earlier terminated, until the expiration, on a country-by-country and product-by-product basis, of the applicable royalty term, at which point the license for such product shall become fully paid-up, royalty-free, perpetual, irrevocable and non-exclusive in such country.
The Agreement also contains customary provisions for termination including by the Company for convenience, by either party in the event of breach of the Agreement, subject to cure, upon a challenge of a party’s licensed patents or upon the other party’s bankruptcy. RemeGen has standard reversion rights in connection with certain early termination events.
The foregoing is only a brief description of the Agreement, does not purport to be complete and is qualified in its entirety by reference to the full text of such Agreement, a copy of which is filed as Exhibit 2.1 hereto and incorporated herein by reference.
Forward-Looking Statements
Certain of the statements made in this report are forward looking, such as those, among others, relating to the expected benefits to the Company of the Agreement; the payment of milestones and royalties in connection with the Agreement; the anticipated activities of the parties under the Agreement, including the development of potential new licensed products; and any other statements that are not historical fact. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include, without limitation: risks related to licensing transactions, such as the risks that disitamab vedotin and/or any new licensed products will not be integrated into the Company’s pipeline successfully or will not perform in clinical testing as expected, in which case, the Company may not recover its investment in disitamab vedotin or in any such new licensed products; risks relating to the future opportunities and plans for disitamab vedotin or any new licensed products, such as risks related to delays, setbacks or failures in clinical development activities and the risks that the parties may not be successful in their development efforts under the Agreement and that, even if successful, the parties may be unable to successfully launch and commercialize disitamab vedotin outside of China and/or
