The FDA’s CDER/DARS intends to award a sole-source, firm-fixed-price purchase order to OrganoTherapeutics SARL for human iPSC-derived hindbrain organoid functional assay services. The work includes providing organoids and materials for in vitro research on drug-induced effects on respiratory-relevant neural circuits, plus 3D MEA functional characterization of electrophysiological responses to drugs affecting respiratory function. The contractor will test FDA-identified drug and reversal-agent combinations, evaluate batch-to-batch reproducibility, collect exposed drug solutions for FDA verification, analyze data, and deliver raw/analyzed data, analysis files, and study reports. The requirement includes twelve scheduled deliveries of human hindbrain organoids to the FDA White Oak Campus—first 96 organoids, then 48 per delivery—with functional characterization performed at the contractor’s laboratory. The anticipated period of performance is eighteen months from award.