|Eligibility for sublicences
||Sublicences can be issued to any qualified entity worldwide.
||Allows manufacturing of the active pharmaceutical ingredient and the finished formulation of LPV/r and RTV anywhere in the world.
|Geographical scope for sale
||Allows for sale of LPV/r and RTV in at least 102 countries (see “Sales outside the licensed territory”).
|Sales outside the licensed territory
||Sales outside the 102 countries are permitted if no granted patent is being infringed. This includes cases in which a compulsory licence is issued. It is estimated that licensees can thus sell the product in 125 countries where 98.8% of children living with HIV reside.
||The license is royalty free.
||Licensees must obtain approval from WHO Pre-qualification, or a Stringent Regulatory Authority. Where such approval is not yet available, temporary approval from a WHO Expert Review Panel may be obtained.
||Sublicensees have the right to combine LPV or RTV with other ARVs and to develop suitable new fixed-dose combinations.
||Data exclusivity is waived in countries with such form of protection, thus facilitating regulatory approval of generics.
||The licence discloses the list of pending and granted patents on LPV/r and RTV worldwide at the time of licence signing.
|Additional flexibilities for licensees:
||Licensees have the right to challenge any of the licensed patents.
Afghanistan, Algeria, Angola, Armenia, Azerbaijan, Bangladesh, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Côte d’Ivoire, Democratic Republic of the Congo, Djibouti, Dominican Republic, Egypt, El Salvador, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Georgia, Ghana, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, Indonesia, Kenya, Kiribati, Korea Dem. Republic, Kyrgyzstan, Laos, Lesotho, Liberia, Libya, Madagascar, Malawi, Malaysia, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia, Moldova, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Republic of the Congo, Rwanda, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Sudan, Swaziland, Syrian Arab Republic, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tunisia, Turkmenistan, Tuvalu, Uganda, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Yemen, Zambia, Zimbabwe