“Developing Country” means countries eligible for support from the Global Alliance for Vaccine Initiatives (GAVI) or successor organization, or which at the effective date of this Agreement are those countries with a Gross National Product of less than US $1,000 per capita per year, and at the effective date of this Agreement include those listed in Appendix G.
“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.
“Public Sector” means the U.S. government and/or the government of a Developing Country, or any nonprofit entity empowered by the U.S. government and/or the government of a Developing Country to act for said government in matters applicable to this Agreement, organizations within the United Nations system including the World Health Organization and UNICEF, and other non-profit organizations when they purchase drugs or vaccines for delivery, manufacture and/or sale in the U.S. and Developing Countries.
10.01 Licensee shall use commercially reasonable efforts to bring the Licensed Products and Licensed Processes to Practical Application. “Commercially reasonable efforts” for the purposes of this provision shall include adherence by Licensee to the Commercial Development Plan at Appendix F and performance of the Benchmarks at Appendix E. For purposes of this Article 10, Licensee’s efforts shall be deemed to include the efforts of its sublicensees.
APPENDIX E—Benchmarks and Performance
6. Developing World Access
It is Licensee’s intent to provide Licensed Product(s) to the Public Sector in the quantity desired by the Public Sector and at the price described below. License therefore agrees:
b) The price at which each Licensed Product is sold to the Public Sector shall be i) preferential to the lowest Private Sector price, and ii) set at the lowest possible level permitting a commercially reasonable return on worldwide sales of each said Licensed Product.