ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT
On November 1, 2022, Affimed GmbH, a subsidiary of Affimed N.V. (together with Affimed GmbH, “Affimed” or the
“Company”) entered into a collaboration agreement (the “Agreement”) with Artiva Biotherapeutics, Inc. (“Artiva”) for the clinical development and commercialization of a combination therapy, for any uses in humans or
animals, comprising Affimed’s product consisting of an innate cell engager referred to as “AFM13” (the “Affimed Product”) and Artiva’s product containing an NK cell referred to as
“AB-101” (the “Artiva Product”). As of the effective date of the Agreement, the following indications are included in the joint development plan: CD30+ Hodgkin Lymphoma and Peripheral T-Cell Lymphoma. While the collaboration is initially limited to the United States, the parties will, upon Affimed’s request, in good faith discuss an expansion to certain other territories.
Artiva has granted Affimed, with respect to the clinical development of the combination therapy an exclusive, and with respect to the
promotion of the combination therapy under the Agreement a non-exclusive, non-transferable (except to affiliates and successors in interest), royalty-free and non-sublicensable (with certain exceptions) license under Artiva patents and know-how. Affimed has granted Artiva a non-exclusive, non-transferable (except to affiliates and successors in interest), royalty-free license and non-sublicensable (with certain exceptions) license under Affimed patents and know-how for use in the clinical development of the combination therapy under the Agreement.
Under the
terms of the Agreement and the development plan agreed between the parties, Affimed will be primarily responsible for the development of the combination therapy, the conduct of the relevant clinical trials and the preparation and filing of
regulatory materials during the clinical development. Artiva will support Affimed in the development, in particular through the supply of the Artiva Product and certain other products to be used in the clinical trials. Affimed will have the sole
right and responsibility to promote the combination therapy according to a jointly aligned promotion plan.
Each party must use
commercially reasonable efforts to perform the tasks assigned to it under the Agreement and the development plan. Affimed must also use commercially reasonable efforts to file an IND for the combination therapy and dose first patients within certain
timeframes. In addition, each party must use commercially reasonable efforts to obtain and maintain regulatory approvals required to commercialize its product as part of the combination therapy. Each party must also use commercially reasonable
efforts to supply its respective product in the quantities required for the clinical trials according to a jointly agreed clinical demand plan (which forms part of the development plan) as well as for commercialization according to jointly agreed
commercial demand projections (which will be updated on a rolling quarterly basis during the commercial phase).
During the term of the
Agreement, and subject to certain exceptions, neither party nor its affiliates is allowed to clinically develop or commercialize any product or therapy comprising its product in the territory for any indication which is included in the development
plan under the Agreement. In addition, during the term of the Agreement, and subject to certain exceptions, Affimed may not combine the Affimed Product with other NK cells, and Artiva may not clinically develop or commercialize the any product that
directly and specifically binds to CD30.
The financial terms of the Agreement foresee that Affimed shall be responsible for all costs
associated with the development of the combination therapy (including all clinical trial costs), except that Affimed and Artiva shall each bear 50% of the costs and expenses incurred in connection with the performance of any confirmatory clinical
trial required by the FDA. Artiva shall be solely responsible for all costs incurred by Artiva for the supply of AB-101 and certain other products used in the clinical trials. In addition, under the Agreement,
the parties agree to make payments to each other to achieve a proportion of 67%/33% (Affimed/Artiva) of revenues generated by both parties from commercial sales of each party’s product as part of the combination therapy (such payment
obligations to expire country-by-country upon expiry of collaboration patents and data exclusivity or upon biosimilar market entry).
Each party will own intellectual property that solely constitutes an improvement or enhancement to its respective background intellectual
property. Other inventions generated in the performance of the development under the Agreement will be jointly owned by Affimed and Artiva. The clinical data generated in connection with the clinical trials under the Agreement shall be jointly
owned, provided that prior to publication of such data, both parties are subject to certain usage restrictions of such data outside the collaboration.