|Eligibility for sublicences
||Sublicences can be issued to entities based in China, India and South Africa.
||Allows manufacturing of active pharmaceutical ingredient and finished formulations in India, China and South Africa.
|Geographical scope for sale
||Allows for sale of TDF in 117 countries home to 90.5% of people living with HIV in low- and middle-income countries (See “Termination or unbundling” below).
|Sales outside the licensed territory
||Sublicensees may supply outside the licensed territory if a country issues a compulsory licence.
||The royalty rate is 3-5% of net sales of finished product. There are no royalties for the sale of the active pharmaceutical ingredient or paediatric formulations.
||Licensees must obtain approval from WHO Pre-qualification, the US FDA or the European Medicines Agency.
||Sublicensees have the right to combine TDF 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 all pending and granted patents in the 112 licensed countries.
||All Indian and South African sub-licensees benefit from a one-time technology transfer.
|Termination (or unbundling)
||Licensees have the right to terminate the agreement at any time on a product-by-product basis. Four companies have taken the MPP-Gilead licence and terminated the TDF part of the licence to supply additional countries in which TDF is not patented (see “Sublicensees” section).
See related licence
Afghanistan, Angola, Anguilla, Antigua and Barbuda, Armenia, Aruba, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belize, Benin, Bhutan, Bolivia, Botswana, British Virgin Islands, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Côte d’Ivoire, Cuba, Democratic Republic of the Congo, Djibouti, Dominica, Dominican Republic, Ecuador, El Salvador, Equatorial Guinea, Eritrea, Eswatini, Ethiopia, Fiji, Gabon, Gambia, Georgia, Ghana, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Jamaica, Kazakhstan, Kenya, Kiribati, Kyrgyzstan, Laos, Lesotho, Liberia, Madagascar, Malawi, Malaysia, Maldives, Mali, Mauritania, Mauritius, Moldova, Mongolia, Montserrat, Mozambique, Myanmar, Namibia, Nauru, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Palau, Papua New Guinea, Philippines, Republic of the Congo, Rwanda, Saint Kitts and Nevis, Saint Lucia, Saint Vincent & the Grenadines, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Sudan, Suriname, Syrian Arab Republic, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tonga, Trinidad and Tobago, Turkmenistan, Turks and Caicos Islands, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Vietnam, Yemen, Zambia, Zimbabwe
Update on progress of MPP sublicensees
Update on progress of MPP licensees: take a look at our table updated every quarter
Aurobindo termination letter for TDF
Cipla termination letter for TDF
Desano termination letter for TDF, EVG, COBI
Emcure termination letter for TDF
Hetero termination letter for TDF
Langhua Pharmaceutical termination letter for TDF, EVG, COBI, BIC
Laurus Labs termination letter for TDF, COBI, EVG
Lupin termination letter for TDF, EVG
Micro Labs termination letter for TDF
Dr. Reddy’s termination letter for TDF, COBI, EVG
Macleod termination letter for TDF
Natco termination letter for TDF