definiens: means all pre - clinical and clinical activities performed by or on behalf ofeither Party with respect to Licensed Compounds or Licensed Products in the Field in theTerritory in an indication, or for the purpose of obtaining Regulatory Approval with respect to suchindication, from the Effective Date until Regulatory Approval of such Licensed Compounds orLicensed Products is obtained for the indication being studied, including : ( a ) identification andearly pre - clinical testing of Licensed Compounds ; ( b ) toxicology, regulatory affairs, pre - clinicalstudies and clinical trials in accordance with the GLPs, GCPs and GMPs or other designatedquality standards and Applicable Laws ; and ( c ) all Manufacturing activities ( until such time asManufacturing of Commercial Supplies commences ) relating to developing the ability to- 8 -THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIALTREATMENT REQUEST