THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR A PROPOSAL. A SOLICITATION DOCUMENT WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Heart, Lung, and Blood Institute (NHLBI) Office of Acquisition (OA) on behalf of the National Human Genome Research Institute, NHGRI), intends to negotiate and award a purchase order on a noncompetitive sole source basis to CreaGen Biosciences, Inc., 23 Rainin Road, Woburn, Massachusetts 01801 for the synthesis of 10 grams of Cmpd 11e. The National Institute of Health (NIH) is the nation’s medical research agency and the primary Federal agency conducting and supporting making medical discoveries that improve people’s health and save lives. The NIH Chemical Genomics Center (NCGC) and the Therapeutics for Rare and Neglected Disease program (TRND) of the National Human Genome Research Institute (NHGRI) in collaboration with Dietz Laboratory at John Hopkins Medical School are working on a collaborative study in advance understanding of the MEK/ERK pathway in Marfan pathology. The collaboration with NCGC/TRND and Dietz Laboratory has been able to show that the clinically used MEK inhibitor RDEA-119 is capable of altering disease progression in mouse models of Marfans syndrome and it is critical for NCGC/TRND to expand the studies with RDEA-119 to judge the ability of the agent to enter clinical trials. Additionally, the synthesis of 10 grams of Cmpd 11e is required to extend testing of the MEK/ERK pathway via the synthesis and exploration of the recently ERK inhibitor described by Vertex Pharmaceuticals. The sole source determination is based on the fact that CreaGen Biosciences has previous knowledge of the synthesis of substituted pyrimidines that are structurally related to Cmpd 11e. CreaGen’s previous experience of the synthetics provides a unique understanding of the challenges of this chemotype. The NCGC chemistry core has worked with CreaGen previously and found this organization to be both effective and efficient. CreaGen will synthesize 10 grams of Cmpd 11e and the Dietz group at John Hopkins Medical School will test within numerous assays and models in order to establish enough data for an IND package utilizing this agent in a clinical setting. Only one responsible source and no other supplies or services will satisfy agency requirements. The delivery point is the National Institutes of Health (NIH), National Human Genome Research Institute, NHGRI), 9800 Medical Center Drive, Building B, Room 2B-2, Rockville, Maryland 20850. Statement of Work • The contractor shall conduct an assessment of the purified material. No material will be sent without purity and characterization requirements that meet the accepted standards for publication (H1 NMR, C13 NMR, HRMS). • The contractor shall identify the synthetic techniques that are not previously recorded in the published literature and forward such methods. • The contractor shall address alterations to the procedure of synthesis as well as abnormalities in the characterization of the material. • The primary task is the synthesis and timely delivery of the material. • The project timeline is variable based upon unforeseen issues with the synthesis. The project will be initiated within four weeks of receipt of purchase order and weekly updates will be required during the duration of the project. Government Furnished Information • The final report of the project shall include consistent NMR and mass spectral data, and shall have an elemental analysis within 0.4% for C, H, and N. The product will be shipped together with a Data Sheet and copies of all spectra taken. Deliverables • The contractor shall provide bi-weekly updates by phone, fax, or email. • The contractor shall provide the synthesized material as a homogenous sample. • The contractor shall provide a print ready master final report included with the above deliverables. Industry Classification (NAICS) Code is 541711, Research and Development in Biotechnology, with size standard of 500 employees, this is a small business set-aside. The acquisition is being conducted under FAR Part 13, simplified acquisition procedures, therefore the requirements of FAR Part 6 B Competitive Requirements are not applicable (FAR Part 6.001).and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-42 (June 16, 2010). This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this synopsis, by July 7, 2010, 7:30 a.m. Eastern Standard Time. The determination by the Government not to compete the proposed contract based upon responses 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 future competitive procurement. Inquires to this announcement, referencing synopsis number NHLBI-PB-(HG)-2010-211-DLM, may be submitted to the National Heart, Lung and Blood Institute, Office of Acquisition, Procurement Branch, 6701 Rockledge Drive, Suite 6149, Bethesda, Maryland 20892-7902, Attention: Dorothy Maxwell. Response may be submitted electronically to [email protected]. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative.

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