definiens: or means all activities relating to obtainingRegulatory Approval of a Licensed Product and all man ufacturing activities undertaken prior tocommencement of supply for Commercialization, including without limitation ( a ) non - clinicaltesting in support of the applicable Licensed Product, toxicology, formulation, Clinical Trials, andregulatory affairs, including without limitation pre paration of Regulatory Filings, and ( b)manufacturing process development for the applicable Lice nsed Compound and/or LicensedProduct, production of clinical supply of the applicable Licensed Compound and/or LicensedProduct, and manufacturing and quality assurance techni cal support activities prior to thecommencement of Commercialization, including without limitation those activities reasonablyrequired for the scale up of manufacturing processes or equipment in preparation for commercialsupply of the applicable Licensed Compound and/or Lice nsed Product . For clarity, does not include research activities inten ded to identify and optimize Antibodiesthat target Alpha - Synuclein