6505--VISN IDIQ LENALIDOMIDE Sole Source Justification

This is a notice of intent to award a Sole-Source only contract and is not a request for quotes. Name of Proposed Contractor Exelan Pharmaceuticals Street Address: 370 W. Camino Gardens, Suite 204 City, State, Zip: Boca Raton, FL 334432 The objective of this action is the procurement for: The purpose of this contract is to establish a reliable and continuous supply of Lenalidomide, an immunomodulatory drug used primarily to treat multiple myeloma, anemia in myelodysplastic syndromes (MDS) in adults, and certain types of lymphoma. Lenalidomide works by enhancing the immune system s ability to fight cancer cells. It inhibits the growth of new blood vessels in tumors and alters the immune response to target and destroy malignant cells. It comes with serious risks that require careful management and monitoring. Contractor shall provide all materials, labor, and equipment necessary to supply Lenalidomide in accordance with all applicable federal regulations, Good Manufacturing Practices (cGMP) and the Food and Drug Administration (FDA) requirements. This is an emergent need to ensure continuous supply, to meet regulatory obligations (Risk Evaluation and Mitigation Strategy REMS) program, and to support patient access.