definiens: shall mean, engaging in research, or pre - clinical, non - clinical or clinical drug developmentactivities, including, but not limited to, test method development, stability testing, toxicology, manufacturing ofsupplies for Development purposes, manufacturing scale - up, analytical method validation, manufacturing processvalidation, cleaning validation, post - approval changes, quality assurance / quality control, statistical analysis, reportwriting, clinical studies, regulatory filing submission and approval and regulatory affairs, but expressly excludingmanufacturing of commercial supplies, provided that, as such term applies to TAIHO, does not includeengaging in any pre - clinical drug development activities, including, without limitation, any discovery, formulation, process development or preclinical studies or modifying any Licensed Products, except only to the extent reasonablynecessary or useful in connection with efforts to obtain Marketing Approval or develop Licensed Products inaccordance with the terms of this Agreement, and in such event, TAIHO shall keep Arcus informed of such activitiesand, at Arcus ’s request, consult with Arcus, in good faith, with respect thereto and how best to proceed . For theavoidance of doubt, any such modified versions of Licensed Products shall be deemed to be Licensed Products underthis Agreement . In addition, TAIHO may only conduct clinical studies of the Licensed Products in the Territory, or(subject to Section 4.12 below ), outside the Territory for the purpose of Developing and Commercializing the LicensedProducts in the Territory . and shall have correlative meanings