ITEM 1.01 |
Entry into a Material Definitive Agreement. |
On October 18, 2022, the Company, a subsidiary of Zymeworks, entered into a License and Collaboration Agreement (the “License and Collaboration Agreement”) with Jazz, granting Jazz exclusive rights to develop and commercialize the Company’s proprietary bispecific HER2 antibody product candidate known as zanidatamab throughout the world, but excluding the People’s Republic of China, Australia, New Zealand, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Uzbekistan, Hong Kong, Taiwan, Macau, Mongolia, South Korea, Brunei Darussalam, Cambodia, Indonesia, Papua New Guinea, Lao People’s Democratic Republic, Malaysia, Myanmar, Philippines, Singapore, Thailand, Timor-Leste, and Vietnam (the “Territory”). BeiGene, Ltd. has exclusive rights, pursuant to an agreement with the Company dated November 26, 2018, as amended (the “BeiGene Agreement”), to commercialize zanidatamab in those countries that are excluded from the Territory.
Licenses. Under the terms of the License and Collaboration Agreement, the Company granted to Jazz an exclusive, royalty-bearing license, with the right to grant sublicenses, under certain of the Company’s intellectual property, to research, develop, manufacture, and commercialize in the Territory pharmaceutical products containing or incorporating zanidatamab or certain related antibodies (such antibodies, collectively, “Licensed Antibodies” such pharmaceutical products, “Licensed Products”). Licensed Antibodies and Licensed Products expressly exclude all antibody-drug conjugates, including the Company’s proprietary antibody-drug conjugate, zanidatamab zovodotin (also known as ZW49). The Company also granted to Jazz a non-exclusive license, with the right to grant sublicenses, under certain of the Company’s intellectual property, to research, preclinically develop and manufacture Licensed Products outside the Territory for the sole purpose of furthering the development and commercialization of Licensed Products in the Territory.
Jazz granted the Company certain licenses, under certain of Jazz’s intellectual property, to develop and commercialize Licensed Antibodies and Licensed Products outside the Territory, to conduct certain development and manufacturing activities with respect to the Licensed Products in the Territory, and to make and have made Licensed Antibodies for incorporation into zanidatamab zovodotin, for development and commercialization both in and outside the Territory. If the BeiGene Agreement is terminated, in whole or in part, Jazz has a right of first negotiation to develop or commercialize any Licensed Product in such countries. The licenses granted by the Company and Jazz are effective upon receipt of clearance relating to the United States Hart-Scott Rodino Antitrust Improvements Act of 1976 (such clearance, the “HSR Clearance”).
Exclusivity. During the Term (as defined below), Jazz and its affiliates are prohibited from performing any clinical development of, or commercialization of, any pharmaceutical product containing a bispecific antibody directed to the ECD2 and ECD4 domains of HER2 in the Territory, other than Licensed Products. During the Term, the Company and its affiliates are prohibited from performing any pre-clinical development (except for certain independent, internal pre-clinical development by the Company or its affiliates) or clinical development of, or commercializing, any pharmaceutical product that is directed to HER2 in the Territory (each, a “Zymeworks Competing Product”), other than Licensed Products; provided that zanidatamab zovodotin is excluded from this restriction. The Company retains the right to grant third parties rights to apply any of the Company’s platforms to derive or generate, without any assistance from the Company, antibodies directed to any biological target where the Company is not aware of the identity of any such target, and the Company retains the right to fulfill its obligations under agreements with its existing platform partners; provided, however, that the Company cannot generate, or grant development or commercialization licenses to, Zymeworks Competing Products in new platform-based agreements entered into after the effective date of the License and Collaboration Agreement.
Development, Regulatory, Manufacturing, and Commercialization. As between Jazz and the Company, Jazz will be solely responsible for all development and commercial activities with respect to Licensed Products in the Territory, and all such development and commercial activities in the Territory shall be at Jazz’s sole cost and expense, except that the Company shall be responsible for the continued conduct of clinical trials for zanidatamab initiated by the Company prior to the execution of the License and Collaboration Agreement (collectively, the “Zymeworks Ongoing Studies”), including those clinical trials initiated by the Company in South Korea, and filing of the first Biologics License Application for the Licensed Product (the “First BLA”), at Jazz’s cost and expense subject to the terms and conditions under the License and Collaboration Agreement. Following regulatory approval of the First BLA or earlier upon Jazz’s written request, the Company will promptly transfer the First BLA to Jazz.
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