On October 16, 2020, Precision BioSciences, Inc. (the "Company"), Les Laboratoires Servier and Institut de Recherches Internationales Servier reported that it entered into Amendment No. 6, dated October 2, 2020 ("Amendment No. 6"), to the Development and Commercial License Agreement by and between Les Laboratoires Servier, Institut de Recherches Internationales Servier and Precision BioSciences, Inc., dated February 24, 2016, as amended (the "Servier Agreement") (Filing, 8-K, Precision Biosciences, OCT 16, 2020, View Source [SID1234568835]).
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Amendment No. 6 amends certain terms of the Servier Agreement solely as applicable to PBCAR0191, the Company’s allogeneic chimeric antigen receptor ("CAR T") cell therapy candidate targeting the well-validated tumor target CD19 developed for the treatment of adult patients with relapsed or refractory ("R/R") non-Hodgkin lymphoma ("NHL") or R/R B-cell precursor acute lymphoblastic leukemia ("B-ALL").
Under Amendment No. 6, the Company is required to complete the ongoing Phase 1/2a clinical trial of PBCAR0191 in adult patients with R/R NHL and R/R B-ALL (the "Clinical Trial") for a specified number of patients in the Phase 1 portion of the Clinical Trial and a number of patients to be determined by the Company in the Phase 2a portion of the Clinical Trial. The Company will be solely responsible for all costs and expenses it incurs to complete the Clinical Trial, including the production and release of all required clinical trial material.
The results of the Clinical Trial will used to determine whether specified development milestones have been achieved with respect to PBCAR0191, in which case, specified corresponding development milestone payments are payable by Servier to the Company. The results of the Clinical Trial will also be used to determine whether Phase 2 readiness has been achieved for PBCAR0191 and Servier may determine whether, subject to payment of a commercial option exercise fee, to exercise its commercial option and proceed with development and commercialization of PBCAR0191. Following completion of the Clinical Trial, the Company is not obligated to conduct any further development activities under the Servier Agreement with respect to PBCAR0191 unless the Company otherwise agrees to conduct such further development activities.
The foregoing description of Amendment No. 6 does not purport to be complete and is qualified in its entirety by reference to Amendment No. 6, a copy of which will be filed with the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020.