|Eligibility for sublicences
||Sublicences can be issued to any qualified entity worldwide.
||Allows manufacturing of the active pharmaceutical ingredient and the finished formulations of RAL anywhere in the world.
|Geographical scope for sale
||Allows for sale of paediatric RAL in at least 92 countries where 98.1% of children living with HIV in the developing world reside (see “Sales outside the licensed territory”).
|Sales outside the licensed territory
||Sales to countries outside the 92 countries are permitted if no granted patent is being infringed. This includes cases in which a compulsory licence has been issued.
||The license is royalty free.
||Licensees must obtain approval from WHO Pre-qualification, or a Stringent Regulatory Authority.
||Sublicensees have the right to combine RAL 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 RAL in the 92 countries at the time of licence signing.
|Additional flexibilities for licensees
||Licensees have the right to challenge any of the licensed patents.
Afghanistan, Angola, Armenia, 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, Egypt, El Salvador, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Georgia, Ghana, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Kenya, Kiribati, Korea Dem. Republic, Kyrgyzstan, Lao PDR, Lesotho, Liberia, Madagascar, Malawi, Maldives, Mali, Mauritania, Mauritius, Micronesia, Moldova, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Papua New Guinea, Paraguay, Philippines, Republic of the Congo, Rwanda, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Swaziland, Syrian Arab Republic, Tajikistan, Tanzania, Timor-Leste, Togo, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Yemen, Zambia, Zimbabwe