National Cancer Institute, Research Contracts Branch, PSAS, 6120 Executive Blvd, EPS/Room 638, Bethesda, MD 20892-7227

68 -- PROVIDE RECOMBINANT HUMAN PAPILLOMAVIORUS TYPE 16 L1 SOL NCI-RFQ-00169-NR DUE 080300 POC Marsha Gorham, Purchasing Agent & Todd Cole, Contracting Officer (301)402-4509 The National Cancer Institutes (NCI) proposes to contract with Novavax, Inc. (formerly Dyncorp), 8320 Guilford Road, Suite C. Columbia, MD 21046 to provide recombinant human papillomavirus type 16 L1 (HPV-16) virus-like particles (VLP) bulk and final container products and the corresponding placebo for phase III clinical trials. The supplies and services herein are commercial as defined in FAR Part 2, and this acquisition is being made in accordance with the test program for using simplified procedures for certain commercial items as authorized in FAR 13.5. To date, Novavax, formerly Dyncorp, has manufactured all HPV virus-like recombinant for the HPV Phase I and Phase II vaccine trials. The clinical grade HPV-16 has been used in these ongoing trials to determine whether, in a double-blind, placebo-controlled setting, intramuscular vaccination with the virus-like particles (VLPs) can protect women against the acquisition of genital infection with HPV-16. If the expected outcome occurs, development of an HPV vaccine that can prevent cervical cancer is a possibility. NCI has been collaborating with the National Institute of Allergy and Infectious Diseases (NIAID) throughout the clinical trails. NIAID successfully used these reagents from Dyncorp in their Phase I clinical trails (Protocol # CB-09052-06). NCI purchased (Purchase Order 263-MQ-918990) the same reagents and utilized them in the Phase II trials which will soon be completed. Novavax is the only source that has produced these particular, virus-like particles via good manufacturing practices and with FDA approval for use in clinical trials. While similar virus-like particles are also made via a commercial process, production by any other source may result in the introduction of new and unknown variables that could inhibit study results, as well as the comparability of study data. In addition, delays in the clinical trials could result since no other firms are believed to have the requisite approval from FDA to produce this particular recombinant. Based on the above, the Government believes that Novavax is the only source that can provide the necessary HPV-16 virus-like particles (VLP) bulk, final container products, and the corresponding placebo This contract is being solicited on a fixed priced basis for 27,000 vials (0.75 ml each) of both human papillomavirus type 16 L1 (HPV-16) final container products and placebo using commercial item procedures and under the authority of 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1 and HHSAR 306-302-1. Only one responsible source and no other supplies will satisfy agency requirements. Interested parties may identify their interest and capability to respond to this requirement. This notice of intent is not a request for competitive quotations. However, all capability statements received within 20 days after publication of this synopsis will be considered by the government. A determination by the Government not to compete this proposed requirement based upon response to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. If you have questions, please contact Todd Cole, Contracting Officer on (301)402-4511. Posted 07/14/00 (W-SN474926). (0196)

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