|Eligibility for sublicences
||Non exclusive sublicences can be issued to any qualified entity in the Territory and in India.
||Allows for the manufacturing of the fixed-dose combination of G/P anywhere in the territory and in India.
|Geographical scope for sale
||Allows sale in 95 countries accounting for 47.5% of the HCV burden worldwide.
|Sales outside the licensed territory
||Sales outside the Territory are permitted if no granted patent is being infringed. This includes cases in which a compulsory licence is issued.
||NGOs, UN-related orgs, other not-for-profits, and funding mechanisms such as PEPFAR, Unitaid, USAID, Global Fund, and others based outside the Territory are eligible to procure generic G/P for use in countries within the Territory.
||The licence is royalty-free.
||Sublicensees must meet WHO pre-qualification standards or the standards of any stringent regulatory authority as defined by the WHO, or, where such approvals are not yet available, must gain temporary approval by WHO Expert Review Panel.
||AbbVie agrees to provide waivers of data exclusivity in countries with such form of protection, thus facilitating regulatory approval of generics. Sublicensees agree not to seek further regulatory exclusivity.
||The licence discloses the list of pending and granted patents in the Territory and in India at the time of licence execution.
||AbbVie will provide, upon MPP request, a copy of clinical data and all non-commercial and non-manufacturing documents to facilitate product registration.
||No restrictions on sublicensee patent challenges.
See related licence
Afghanistan, Angola, Antigua and Barbuda, Bangladesh, Belize, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Cook Island, Côte d’Ivoire, Democratic Republic of the Congo, Djibouti, Dominica, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Fiji, Gabon, Gambia, Georgia, Ghana, Grenada, Guinea, Guinea-Bissau, Guyana, Haiti, Indonesia, Jordan, Kenya, Kiribati, Laos, Lesotho, Liberia, Libya, Madagascar, Malawi, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Niger, Nigeria, Niue, Pakistan, Palau, Papua New Guinea, Philippines, Rep., 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, Swaziland, Tanzania, Timor-Leste, Togo, Tunisia, Turkmenistan, Tuvalu, Uganda, Vanuatu, Vietnam, West Bank & Gaza, Yemen, Zambia, Zimbabwe