ANTIVIRAL PRODUCTS Clause Samples

ANTIVIRAL PRODUCTS. We hire third parties to manufacture our antiviral drugs for clinical and commercial purposes, including VISTIDE, adefovir dipivoxil tablets and tenofovir DF tablets. ▇▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ manufactures Tamiflu. We have no commercial-scale manufacturing facilities for our antiviral products that are qualified under the FDA's current Good Manufacturing Practices, and we have no current plans to establish these facilities. In using third parties, we cannot be certain that they will perform their obligations effectively and on a timely basis. If these third parties do not perform effectively and timely, our clinical trials or regulatory filings could be delayed or we could be unable to deliver our products to customers on a timely basis, and this would adversely affect our operating results. We have one supplier that has been approved by the FDA and EMEA to manufacture the cidofovir used in VISTIDE and a single FDA approved supplier for the final drug product, and we have submitted information on a second cidofovir supplier to assure our supplies. We manufacture the active ingredient in tenofovir DF in small quantities at our own facilities and in larger quantities through two contract manufacturers. The final tenofovir DF and adefovir tablets used in our clinical trials are manufactured at two contract manufacturing sites. If manufacturing at any of these sites we use were interrupted for any reason, our ability to complete our clinical trials or ship our products would be impaired, and this would adversely affect us. For our antiviral products in particular, we will need to develop additional manufacturing capabilities and establish additional third party suppliers in order to manufacture sufficient quantities of our product candidates to complete clinical trials and to manufacture sufficient quantities of any candidates that are approved for commercial sale. If we are unable to develop manufacturing capabilities internally or contract for large scale manufacturing with third parties on acceptable terms for our antiviral products, our ability to conduct large-scale clinical trials and meet customer demand for commercial products would be adversely affected. We believe that the technology we use to manufacture our products and compounds is proprietary. For our antiviral products, we have disclosed all necessary aspects of this technology to contract manufacturers to enable them to manufacture the products and compounds for us. We have agreements with these manufa...