definiens: shall mean such non - patented and unpublished non - clinical, pre - clinical and clinical documentation, information, and data including information and data in U.S. ! NO [ # 59,302J, U.S. lND [ # 63,763.1, and all resulting marketing applications worldwide relating to the use of Toremifene or any SERM in the Field, that is owned or controlled by, and disclosable by and available to, GTX and its Affiliates as of the Effective Date or at any time during the Term, including but not limited to all registration materials for the Product developed, acquired or compiled by GTX and/or its Affiliates as of the Effective Date or at any time during the Term, and all non - patented and unpublished documentation, information and data relating to the formulation, manufacture and/or quality control of the Product that is owned or controlled by GTX and/or its Affiliates as of the Effective Date or at any time during the Term