definiens: shall mean such non - patented and unpublished non - cl inical, pre - clinical and clinical documentation, information, and data relat ing to the Orion Product that is owned or controlle d by, and disclosable by and available to, Orion and its Affi liates as of the Effective Date or at any time duri ng the Term which is necessary for the development by GTX of Pr oduct for use in the Field ( including without limit ation filing an application for Regulatory Approval for t he Product for use in the Field ), including informa tion and data in U.S. NDA [ * ] relating to the Orion Product, registration materia ls for the Orion Product, documentation, information and data relating to the formulation an d / or quality control of the Orion Product . Except a s otherwise provided in Sections 7.6, 13.9, 15.1, 16.3.2, 16.4 and 20.2, Orion Know - How shall exclude information relating to Orion ’s manufacture of Toremifene ( as defined be low ) and Orion Product ( as defined below )