definiens: shall mean, with respect to each Licensed Product, the use of the Licensed Product for the treatment, diagnosis or prevention of a specific disease or medical condition in humans where, with respect solely to such specific disease or medical condition, there is a valid technical rationale for use of Licensed Product in such indication and the peak sales of Licensed Product alone or as part of a Combination Product ( using a Combination Product Amount -type adjustment ), as evidenced by appropriate market research, are expected to be equal to or greater than * * * per annum in the United States . * * * APPROXIMATELY 8 LINES OMITTED * * * 1.24 shall mean supplies of Licensed Product in suitable final packaged form, as specified under any manufacturing agreement between the Parties, manufactured in compliance with GMP, and ready to be offered for commercial sale for use in the Field in the Territory by [COMPANY] and/or [COMPANY], and/or their Affiliates, or permitted licensees or sublicensees