definiens: means all pre - clinical, non - clinical or clinical r esearch or other activities performed by or on behalf of either Party with respect to a License d Product in the Field in the Territory in an indic ation, or for the purpose of obtaining Regulatory Approval with r espect to such indication, from the Effective Date until Regulatory Approval of such Licensed Product is obt ained for the indication being studied including : ( a ) early pre - clinical testing of a Licensed Product and rese arch regarding the Licensed Adjuvant ; ( b ) toxicolog y, regulatory affairs, pre- clinical studies and clini cal trials in accordance with the GLPs, GCPs and GM Ps or other designated quality standards and Applicable Laws ; a nd ( c ) all Manufacturing activities ( until such tim e as Manufacturing of Commercial Supplies commences ) rel ating to developing the ability to Manufacture Lice nsed Product, including process and formulation developm ent, process validation, manufacturing scale - up, manufacturing and analytical development, and quali ty assurance and quality control . When used as a ve rb, means to engage in Development