definiens: or means, with respect to a Collaboration Compound, Ca ndidate Drug or Product for a Primary Indication, Schizophr enia or a Small Market Indication, all non - clinical and clinical activities required to obtain Commercializ ation Regulatory Approval of such Product ( includin g any Product that contains such Collaboration Compound o r Candidate Drug ) in accordance with this Agreement up to and including the obtaining of Commercialization Regulatory Approval of such Product for such Prima ry Indication, Schizophrenia or Small Market Indicatio n. For purposes of clarity, these activities : ( a ) i nclude test method development and stability testing, regulator y toxicology studies, formulation, process developm ent, manufacturing, manufacturing scale - up, development- stage manufacturing, quality assurance / quality cont rol development, statistical analysis and report writin g, Clinical Trial design and operations, preparing and filing Drug Approval Applications, and all regulatory affa irs related to the foregoing ; ( b ) do not include no n - clinical studies in animals conducted, at whatever stage, wi th Basket Compounds after the Amendment No . 5 Date that are not regulatory toxicology studies . When used as a verb, means to engage in Developmen t and has a corresponding meaning . ” 8 . Section 1.116 of the Agreement is hereby amended by deleting the reference to therein and replacing it with a reference to 9 . Section 1.208 of the Agreement is hereby deleted in its entirety and replaced with the following : means the period commencing on the Effective Date and ending on the Amendment No . 5 Date . ” 10 . The Agreement is hereby amended by adding the f ollowing new Section 1.219A : means each of ( a ) [ * * * ] having the diagnostic crit eria identified in ICD-9 [ * * * ] as in effect in the United States as of the Amendment No . 5 Date, as such ICD-9 criteria m ay be updated or superseded thereafter, and ( b ) [ * * * ] . ” Portions of this Exhibit, indicated by the mark were omitted and have been filed separately w ith the Securities and Exchange Commission pursuant to the Registrant ’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended