“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.
10.02 Upon the First Commercial Sale, until the expiration of this Agreement, Licensee shall use commercially reasonable efforts to make Licensed Products and Licensed Processes reasonably accessible to the United States public. For the 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:
a) To provide a written report to PHS , within six months of a Licensed Product being approved for marketing in the U.S. or Europe detailing the potential Public Sector requirement for Licensed Product(s) to fulfill the public health need in Developing Countries, said report shall include the effect of any approved competing products being offered to the Public Sector. The report shall describe how Licensee intends to fulfill said Public Sector requirement for Licensed Product(s). A similar report shall be required within six months of marketing approval of the [*] of Licensed Product(s). Licensee shall amend the Commercial Development Plan and this Benchmarks and Performance Appendix as appropriate.
c) A Licensed Product shall be sold to the Public Sector within two years of marketing approval of said Licensed Product in the U.S. or Europe, and thereafter Licensee agrees to use commercially reasonable efforts to meet any delivery date and in the quantities required in any order placed for Licensed Product(s) placed by the Public Sector.