definiens: or means with respect to any ( a ) material, item of i nformation, method, data or other know - how, or ( b ) intellectual property right, in ea ch case the possession of which ( whether by ownersh ip or license, or other contractual right other than purs uant to this Agreement ) by a Party or its Affiliate s allows a Party the ability to grant to the other Party acces s to and/or a license as provided herein under such item or right without violating the terms of any agreement or oth er arrangement with any Third Party existing before or after the Date of Agreement or shall mean, pre - clinical and clinical drug develo pment activities, including, among other things, pharmacology, pharmaceutical de velopment, toxicology, statistical analysis and rep ort writing, Phase I Studies, Phase HA Studies, Phase J IB Studies, Phase HIA Studies, Phase MB Studies, FD A - required Phase IV Studies, Independent pre - clinical and clinical Quality Assurance and Audit activitie s, product approval and registration and regulatory affairs ac tivities, related to the foregoing . When used as a verb, ‘ Develop ” means to engage in Development