“Practical Application” means to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and in each case, under such conditions as to establish that the invention is being utilized and that its benefits are to the extent permitted by law or Government regulations available to the public on reasonable terms.
10.1 The Licensee shall use its reasonable commercial efforts to bring the Licensed Products and Licensed Processes to Practical Application. “Reasonable commercial efforts” for the purposes of this provision shall include adherence to the Commercial Development Plan in Appendix E and performance of the Benchmarks in Appendix D.
10.2 Upon the First Commercial Sale, until the expiration or termination of this Agreement, the Licensee shall use its reasonable commercial efforts to make Licensed Products and Licensed Processes reasonably accessible to the United States public.
10.3 Licensee agrees, after its First Commercial Sale, to make reasonable quantities of Licensed Products or materials produced through the use of Licensed Processes available to patient assistance programs at cost. Patient assistance programs are programs run by pharmaceutical companies to provide free medications to people who cannot afford to buy their medicine. For each indication in each calendar year, the quantity of Licensed Products to be made available under this provision available to patient assistance programs at cost shall be defined as the higher of: (i) the maximum quantity of Licensed Products for such indication that was available in the previous calendar year (whether or not such Licensed Products were actually supplied); and (ii) five (5) percent of the total number of Licensed Products for such indication prescribed within the United States and its dependant territories in the previous calendar year.