Partnerships are a critical element of increasing access, and Gilead has implemented several collaborative initiatives to help improve care and treatment for those individuals living with HIV/AIDS in the developing world.

Manufacturing

In 2005, Gilead established a facility in The Bahamas to manufacture tenofovir DF, the active drug substance in Viread, for resource-limited countries through a cooperative effort with PharmaChem Technologies and the Grand Bahama Port Authority. That same year, Gilead entered into a non-exclusive partnership with South Africa-based Aspen Pharmacare, under which Aspen manufactures finished product for low pricing tier countries and distributes Gilead therapies throughout Africa. In late 2007, Aspen was extended the option to manufacture and distribute generic versions of Gilead's products in Africa, while Gilead receives a 5 percent royalty on sales. Aspen is also sourcing active pharmaceutical ingredient (API) from our Indian Generic partners.

Generics

Gilead has also entered into non-exclusive license agreements with 13 generic manufacturers in India - Alkem Laboratories Ltd., Aptuit Laurus Private Ltd., Aurobindo Pharma Ltd., Cadila Healthcare Ltd., Emcure Pharmaceuticals Ltd., FDC Ltd., Hetero Drugs Ltd., Matrix Laboratories Ltd., Medchem International, Ranbaxy Laboratories, SeQuent Scientific Ltd., Shasun Chemicals & Drugs Ltd. and Strides Arcolab Ltd. Under these license agreements, our partners will produce active pharmaceutical ingredient and tablets and distribute high-quality generic versions of Gilead's HIV medications in 95 resource-limited settings.

These agreements have been established based on these companies' expertise in achieving efficiencies in manufacturing, breaking down in-country barriers, navigating healthcare systems and distributing HIV products in countries most affected by the HIV/AIDS epidemic. These arrangements include a full technology transfer to enable faster ramp-up of production of high-quality product, and allow for the manufacture of commercial quantities of both active pharmaceutical ingredient (API) and finished product. The generic companies are free to establish pricing for their products and Gilead receives a 5 percent royalty on sales of finished product. Gilead expects that multiple manufacturers will ensure competitive pricing, thus helping to achieve broader access for patients with HIV/AIDS. Several partners have already received tentative U.S. Food and Drug Administration approval through the U.S. President's Plan for AIDS Relief (PEPFAR) program for generic Viread and Truvada, thus significantly increasing patient access to high-quality, low-cost HIV treatment.

Distribution

Gilead has established a network of distributors to assist with forecasting, registration, importation and distribution of our products. Our distribution partners are chosen based on their ability to accelerate the regulatory process by leveraging their knowledge of local systems, to manage outreach and on-the-ground logistics, and to provide medical education and to secure distribution of Gilead's HIV drugs where and when they are needed most.

We provide comprehensive, regional-specific training for our distribution partners. This training helps to effectively ensure safe use of Gilead's products by helping our distributors gain a solid understanding of our products in order to provide clinical and community-based education, address medical information requests and set up standard reporting systems within their respective regions.

Gilead and our distribution partners share a common commitment to provide sustainable access for patients suffering from HIV, and have worked with us to keep distribution costs low.