Development Stage. a. Goal: to prepare an analytically validated, Investigational Use Only Assay using the […***…] antibody, the Benchmark ULTRA platform and OptiView detection and verified to the United States’ FDA specifications that may be used to select patients in registrational trial(s) of BLU-554 in hepatocellular carcinoma (“HCC”). b. Anticipated Timeline […***…] for HCC (the “Intended Use”). Ventana will use commercially reasonable efforts to have Ventana IUO ready for BLU-554 pivotal Clinical Trials. In the event the Ventana IUO will not be ready, a Joint Project Team will identify contingencies to select patients for such trials such as incorporating the Ventana CAP CLIA Lab. c. Estimated Fees to Blueprint for the Intended Use: […***…] (excluding passed through1 and optional costs as described further, and assuming Blueprint has elected to […***…])
Appears in 2 contracts
Sources: Master Collaboration Agreement (Blueprint Medicines Corp), Master Collaboration Agreement (Blueprint Medicines Corp)