Gilead’s Voluntary Licensing Agreements for Remdesivir with 5 generic companies

Gilead has signed non-exclusive voluntary licensing agreements with five generic pharmaceutical manufacturers based in India and Pakistan to further expand supply of remdesivir. The agreements allow the companies – Cipla Ltd., Ferozsons Laboratories, Hetero Labs Ltd., Jubilant Lifesciences and Mylan – to manufacture remdesivir for distribution in 127 countries. The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access.

Under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for remdesivir to enable them to scale up production more quickly. The licensees also set their own prices for the generic product they produce. The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.

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The agreements permit distribution in the following countries:

• Afghanistan
• Algeria
• Angola
• Anguilla
• Antigua & Barbuda
• Armenia
• Aruba
• Azerbaijan
• Bahamas, The
• Bangladesh
• Barbados
• Belarus
• Belize
• Benin
• Bermuda
• Bhutan
• Botswana
• British Virgin Islands
• Burkina Faso
• Burundi
• Cambodia
• Cameroon
• Cape Verde
• Cayman Island
• Central Af R.
• Chad
• Comoros
• Congo Rep.
• Cook Islands
• Costa Rica
• Cote d’Ivoire
• Cuba
• Curacao
• Djibouti
• Dominica
• Dominican Republic
• Egypt
• El Salvador
• Equatorial Guinea
• Eritrea
• Eswatini (Swaziland)
• Ethiopia
• Fiji
• Gabon
• Gambia, The
• Georgia
• Ghana
• Grenada
• Guatemala
• Guinea
• Guinea Bis
• Guyana
• Haiti
• Honduras
• India
• Indonesia
• Jamaica
• Kazakhstan
• Kenya
• Kiribati
• Korea, Dem. People’s Rep. (North Korea)
• Kyrgyzstan
• Lao DR (Laos)
• Lesotho
• Liberia
• Libya
• Madagascar
• Malawi
• Maldives
• Mali
• Marshall Islands
• Mauritania
• Mauritius
• Micronesia, Fed. Sts.
• Moldova
• Mongolia
• Montserrat
• Morocco
• Mozambique
• Myanmar
• Namibia
• Nauru
• Nepal
• Nicaragua
• Niger
• Nigeria
• Pakistan
• Palau
• Panama
• Papua New Guinea
• Philippines
• Rwanda
• Samoa
• Sao Tome and Principe
• Senegal
• Seychelles
• Sierra Leone
• Sint Maarten (Dutch part)
• Solomon Islands
• Somalia
• South Africa
• South Sudan
• Sri Lanka
• St. Kitts and Nevis
• St. Lucia
• St. Vincent and the Grenadines
• Sudan
• Suriname
• Tajikistan
• Tanzania
• Thailand
• Timor-Leste
• Togo
• Tonga
• Trinidad & Tobago
• Tunisia
• Turkmenistan
• Turks & Caicos
• Tuvalu
• Uganda
• Ukraine
• Uzbekistan
• Vanuatu
• Vietnam
• Zambia
• Zimbabwe

Gilead’s Voluntary Licensing Agreements for Remdesivir

• Nature of License: Non exclusive.
• Production of the remdesivir will be challenging as it requires scarce raw materials, with their own lengthy production time, and specialized manufacturing capabilities with limited global capacity. Any disruption to the supply chain impacting these scarce raw materials and other manufacturing inputs could reduce the amount of Remdesivir produced and increase the time it takes to do so
• Large and developed markets like the US, China, the UK, the European Union, Australia and Japan are not included in the list of countries. Certainly there may be different agreement or licensing deal in coming days for those countries.
• The US Food and Drug Administration had granted remdesivir, an investigational antiviral therapy developed by Gilead, the Emergency Use Authorization (EUA) to treat Covid-19, helping facilitate broader use of the intravenous injection to treat hospitalized patients with severe Covid-19 disease. The EUA was based on available data from two global clinical trials, including Gilead’s own global Phase 3 study evaluating remdesivir in patients with severe disease.