Summary
Gilead Sciences, Inc. (GILD) filed an 8-K on November 14, 2005, to report the entry into a material definitive agreement. Specifically, on November 10, 2005, the company entered into a Restated and Amended Toll Manufacturing Agreement with Altana Pharma Oranienburg GmbH. This agreement, effective November 7, 2005, amends and restates a prior agreement from August 1, 2003. The primary purpose of this amended agreement is to have Altana Pharma Oranienburg GmbH manufacture and supply key Gilead products, including Viread® (tenofovir disoproxil fumarate) and Truvada® (emtricitabine and tenofovir disoproxil fumarate), in bulk or packaged form. This manufacturing arrangement is crucial for Gilead's supply chain and the consistent availability of these important HIV treatments. The agreement is contingent on the regulatory approval of Altana's manufacturing facility in Germany.
Key Highlights
- 1Gilead Sciences entered into a Restated and Amended Toll Manufacturing Agreement with Altana Pharma Oranienburg GmbH, effective November 7, 2005.
- 2The agreement amends and restates a prior toll manufacturing agreement from August 1, 2003.
- 3Altana Pharma Oranienburg GmbH will manufacture and supply Viread® (tenofovir disoproxil fumarate) and Truvada® (emtricitabine and tenofovir disoproxil fumarate) for Gilead.
- 4The agreement covers both bulk and packaged forms of the specified finished products.
- 5Gilead or its affiliates/contract manufacturers will supply the active pharmaceutical ingredients (APIs) to Altana.
- 6The effectiveness of the agreement is conditioned upon the acceptance of Altana's manufacturing facility in Oranienburg, Germany, by regulatory authorities.