definiens: shall mean that certain [COMPANY] - sponsored study of the PET Ligand described inProtocol No . PP21352 ( and subsequent amendments to same ), entitled “ A Single - Center, Open Label, Non - Randomized, Single or Repeat Dose Study to Investigate the Biokinetics, Radiation Dosimetry, and Safety of [ 11C]-RO5041184 as an Imaging Agent for Quantifying Brain 5HT6 Receptors with Positron Emission Tomography ( PET)Following Intravenous Administration of the Radioligand in Healthy Volunteers . ”1.22 means an Investigational New Drug Application filed with the FDA pursuant to 21 CFR 312.20, or thecorresponding filing in any country or regulatory jurisdiction other than the United States required for the clinicaltesting in humans of a pharmaceutical product