CET Brand Name Only Award Notice

SOLE SOURCE STATEMENT RCP/PR Number: N3946717RC00094 1. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING ACTIVITY: This is a Sole Source Statement. The Naval Medical Logistics Command is the contracting activity, acting on behalf of behalf of the Naval Medical Research Unit, San Antonio (NAMRU-SA). 2. NATURE/DESCRIPTION OF CONTRACT ACTION: The proposed acquisition is for a commercial, indefinite delivery indefinite quantity (IDIQ) contract with Firm Fixed Price (FFP) delivery orders to supply amniotic membrane mesenchymal stromal cells. The proposed source is Cellular Engineering Technologies Inc. located at 2500 Crosspark Road, Suite E110, Coralville, IA 52241. 3. DESCRIPTION OF REQUIRED SUPPLIES/SERVICES: The proposed IDIQ contract will provide amniotic membrane mesenchymal stromal cells to continue ongoing studies at NAMRU-SA. The cells must be extracted from their respective tissues using the exact same process and are frozen down at passage one (1), as done in earlier studies. The estimated IDIQ minimum would be two (2) vials of human amniotic mesenchymal stromal cells. The estimated minimum per 12 month period and the IDIQ will not have a guaranteed minimum ordering quantity past the base period. The estimated IDIQ maximum per 12 month period will be 30 vials of human amniotic mesenchymal stromal cells. The IDIQ will not have a guaranteed minimum ordering quantity past the base period. The cells must be extracted from their respective tissues using the exact same process as the stromal cells utilized in earlier studies. Stromal cells are capable of differentiating up to passage four (4). Beyond passage four (4), the cells lose their differentiation ability. Due to the need to expand out the cells to passage three (3) in order to obtain a sufficient number of cells that will differentiate at passage four (4), the cells must be delivered having been frozen down at passage one(1) or earlier. The stromal cells for this requirement must be frozen down at passage one (1) or earlier and aliquoted into a 1mL volume of 500,000 cells per vial. The ordering period for this IDIQ contract is divided into a base and four option periods, each consisting of 12 months, for a total of 60 months (if all options are exercised). Funding will be provided on the firm fixed price delivery orders and are expected to be FY 2017 RDT&E funds. 4. IDENTIFICATION OF THE JUSTIFICATION RATIONALE AND/OR DEMONSTRATION OF CONTRACTOR'S UNIQUE QUALIFICATIONS: The authority for this sole source is FAR 13.106-1(b); Brand Name. Only one manufacturer will satisfy agency requirements. The manufacturer has a distributor. Market research was conducted by the SMEs at NAMRU-SA. The SMEs at NAMRU-SA are CDR Sheppard and Dr. Alexander Burdette. Upon completion of this research, it was determined that amniotic membrane mesenchymal stromal cells are available from multiple sources. However, each company extracts them from their respective tissue in different ways which significantly alters the cell's ability to grow and differentiate into osteoblasts. Therefore, it is not possible to directly compare, for example, human amniotic membrane mesenchymal stromal cells from company A to human amniotic membrane mesenchymal stromal cells from company B. Upon completion of this research, it was determined that although stromal cells are available from multiple suppliers, only CET manufactures the cell type that is required for this project, which were extracted from their respective tissues using the exact same process and are frozen down at passage one (1), as done with the stromal cells used in the earlier studies. CET was the sole manufacturer of stromal cells to the earlier studies. No stromal cells except those manufactured by the same company (CET), that provided the cells for the previous research, will meet the Governments requirement. The stromal cells to be purchased under this IDIQ will be used to build upon and advance the research conducted in previous studies. CET is the only company that can manufacture cells compatible with the previous body of historical research and subsequent data in which future research will build on. Any other company's stromal cells are incompatible with the historical data and would require all of the previous research to be re-conducted in order to establish a body of historical data compatible with a non-CET stromal cell. This is impossible due to funding and time constraints. All experiments would require a complete start-over and the resources thus far utilized for the project would be wasted. NAMRU-SA has already verified that the cell type from CET differentiates into osteoblasts. Therefore, this cell type must be obtained from CET, or a distributor of CET cells, in order to enable completion of the project with consistency and continuity of the currently collected data. The cells must be frozen down at passage one (1) or earlier. The reason for this is that stromal cells are capable of differentiating up to passage four (4). Beyond passage four (4), the cells lose their differentiation ability. Because there is a need to expand out the cells to passage three (3) to obtain a sufficient number of cells to differentiate at passage four (4), the cells must be delivered frozen down at passage 1 or earlier. On 02 August 2017, the Contracting Specialist contracted CET to identify if CET has distributors. CET stated that they have one (1) authorized distributor: Mayflower Bioscience. Mayflower is the only known distributor of the CET brand stromal cells that are necessary to meet the Government's needs. Based on the information attained during market research, this sole source statement is being executed to limit offers to those of the manufacturer of the sole product (brand name) that will meet the Government's requirement (CET) and their sole distributor (Mayflower Bioscience). 5. SYNOPSIS OF INTENT TO SOLE SOURCE: NMLC will synopsize this requirement on the FedBizOpps website (FBO.gov) with a combined synopsis / solicitation. In accordance with FAR 5.102(a)(6), because this solicitation will restrict proposals to those of the manufacturer (CET) and their sole distributor (Mayflower Bioscience), NMLC will post a redacted copy of this sole source statement with the combined synopsis / solicitation.