Sole Source Statement

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 chorionic membrane mesenchymal stromal cells. The proposed source is ScienCell Research Laboratories, Inc. located at 6076 Corte Del Cedro, Carlsbad, CA, 92011-1514. 3. DESCRIPTION OF REQUIRED SUPPLIES/SERVICES: The requirement is for an IDIQ contract with FFP delivery orders to supply chorionic membrane mesenchymal stromal cells. The vials are required to be frozen down at passage one (1) or earlier and to be aliquoted into a 1mL volume of 500,000 cells per vial. The contractor will provide between delivery of up to 30 vials of cells during the 12 month base period and each of the four 12 month option periods (for a total ordering period of 60 months if all options are exercised). The delivery dates will be delineated at the task order level. The total estimated value of this IDIQ contract is $100,275.00 for the base and four option periods. The total proposed contract value includes shipping costs for up to 5 shipments at a price of $75 per shipment. 4. STATUTORY AUTHORITY PERMITTING OTHER THAN FULL AND OPEN COMPETITION. The authority for this sole source is FAR 13.106-1(b); only one responsible source and no other supplies or services will satisfy agency requirements. 5. RATIONALE JUSTIFYING USE OF CITED STATUTORY AUTHORITY. 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 chorionic 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 chorionic membrane mesenchymal stromal cells from company A to human chorionic membrane mesenchymal stromal cells from company 8. Upon completion of this research, it was determined that although stromal cells are available from multiple suppliers, only ScienCell, sells 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 the stromal cells used in the earlier studies were. ScienCell was the sole supplier of stromal cells to the earlier studies, No stromal cells except those provided by the same company (ScienCell) 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. ScienCell is the only company that can provide cells compatible with the previous body of historical research and subsequent data that future research will build off of. Any other company's stromal cells are incompatible with the historical data and would require all of the previous research to be re-conducted to establish a body of historical data compatible with a non ScienCell 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. 6. DESCRIPTION OF EFFORTS MADE TO SOLICIT OFFERS FROM AS MANY OFFERORS AS PRACTICABLE. NMLC synopsized the Notice of Intent to Sole Source to the FedBizOpps website (FBO.gov) on August 16, 2017. No responses were received and as such no potential offers responded with a capability statement or other material that would lead the Government to believe that more than one capable source exists that can meet the Governments requirement. Market research was conducted and documented in section 5 and that market research concluded that no sources exist that can meet the Governments requirement except for ScienCell. 7. DETERMINATION OF FAIR AND REASONABLE COST. The contracting officer has determined the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable. 8. ACTIONS TO REMOVE BARRIERS TO FUTURE COMPETITION. For the reasons set forth in Paragraph 5, the Naval Medical Logistics Command has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, the Naval Medical Logistics Command will assess whether competition for future requirements is feasible. 9. CONTRACTING POINT OF CONTACT. The point of contact at Naval Medical Logistics Command is Jennifer Reed, Code 05, at DSN 343-1200, commercial (301) 619-1200 or by e-mail at jennifer.m.reed20.civ@mail.mil. See Approvals on Next Page