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Brand Name Only for PromoCell Cells - Justification and Approval #17-10167

General Information

Document Type:AWARD
Posted Date:Oct 11, 2017
Category: Research and Development
Set Aside:N/A

Contracting Office Address

Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States

Description

Contract Award Date:         DTD 092917

Contract Award Number:    CNT N6264517D5040

Contract Award Amount:     AMT $52,809.00

Contract Line Item Number: 

Contractor:     TO PromoCell BioScience Alive GMBH BioMedIz, Sickingenstr. 63-65, Heidelberg, 69126, GermanyJUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN COMPETITION 1. Contracting Activity. The Naval Medical Logistics Command (NMLC), Fort Detrick, MD is the contracting activity. The requiring activity is the Naval Medical Research Unit San Antonio (NAMRU-SA), located at 3650 Chambers Pass, Building 3610, JBSA Fort Sam Houston, TX 78234 2. Description of the Action Being Approved. NAMRU-SA has a requirement for an Indefinite Delivery Indefinite Quantity (IDIQ) contract for human bone marrow derived mesenchymal stromal cells, human adipose derived mesenchymal stromal cells and human umbilical mesenchymal stromal cells. The proposed source is PromoCell GmbH, located at Sickingenstr. 63/65, 69126 Heidelberg, Germany. 3. Description of Supplies/Services. The proposed IDIQ contract will provide human bone marrow derived mesenchymal stromal cells, human adipose derived mesenchymal stromal cells and human umbilical 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 the stromal cells used in the earlier studies were. The estimated IDIQ minimum would be two (2) vials of human bone marrow-derived mesenchymal stromal cells, two (2) vials of human adipose derived mesenchymal stromal cells and two (2) vials of human umbilical mesenchymal stromal cells for a combined minimum of six (6) vials. The estimated minimum is 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 would be 30 vials of human bone marrow-derived mesenchymal stromal cells, 30 vials of human adipose derived mesenchymal stromal cells and 30 vials of human umbilical mesenchymal stromal cells for a combined maximum of 90 vials. 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 used in the earlier studies were. The cells must be frozen down at passage one (1) or earlier and aliquoted into a 1mL volume of 500,000 cells per vial because stromal cells are capable of differentiating up to passage 4. Beyond passage 4, the cells lose their differentiation ability. Because there is a need to expand out the cells to passage 3 to obtain a sufficient number of cells to differentiate at passage 4, the cells must be delivered having been frozen down at passage 1 or earlier. The cells must 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 Research Development Testing and Evaluation (RDT&E) funds. 4. Estimated Dollar Value. The estimated value of each of the base and option ordering periods is up to $56,390.00. This estimated price includes shipping costs for up to 5 shipments. The total estimated contract value is $281,950.00. The flat rate price for packaging and delivery per shipment is $52. 5. Statutory Authority Permitting Other Than Full and Open Competition. 41 U.S.C. 1901, (as implemented by FAR 13.501); Brand Name Only 6. Rationale Justifying Use of Cited Statutory Authority. Market research was conducted by the Subject Matter Experts (SME, CDR Sheppard and Dr. Alexander Burdette) at NAMRU-SA. 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 cells 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 PromoCell 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. PromoCell was the sole supplier of stromal cells to the earlier studies. No stromal cells except those provided by the same company (PromoCell) 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. PromoCell 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 companys 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 PromoCell 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 these 3 cell types from PromoCell differentiate into osteoblasts. Therefore, all 3 cell types being compared in this project must be obtained from PromoCell in order to complete the project with consistency and continuity with the previously collected data. Market research determined that Promocell has two authorized distributors: VWR International, LLC and Fisher Inc. Based on the information attained during market research, this J&A is being executed to limit offers to those of the manufacturer and authorized distributors that can provide the brand name product that is the sole product that will meet the Governments requirement. 7. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable. NMLC will synopsize this requirement on the FedBizOpps website (FBO.gov) with a combined synopsis / solicitation. In accordance with FAR 13.501(a)(1)(iv) and FAR 5.102(a)(6), because this solicitation will restrict proposals to those of the manufacturer (Promocell) and their authorized distributors (VWR International, LLC and Fisher Inc), NMLC will post a redacted copy of this J&A with the combined synopsis / solicitation. 8. Determination of Fair and Reasonable Cost. The Contracting Officer will perform a price analysis in order to determine that the anticipated cost to the Government of the services covered by this J&A will be fair and reasonable. 9. Actions to Remove Barriers to Future Competition. For the reasons set forth in Paragraph 6, (NMLC) has no plans at this time to solicit for future contracts for the type of supplies covered by this document using full and open competition. If another potential source emerges, (NMLC) will assess whether competition for future requirements is feasible. If future requirements exist that do not involve the same research efforts, the government will solicit through full and open competition to remove barriers. 10. Contracting Point of Contact. The point of contact at Naval Medical Logistics Command is Jennifer M. Reed, Code 05, (301) 619-1200 or by e-mail at Jennifer.m.reed20.civ@mail.mil.|**|TO PromoCell BioScience Alive GMBH BioMedIz, Sickingenstr. 63-65, Heidelberg, 69126, GermanyJUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN COMPETITION 1. Contracting Activity. The Naval Medical Logistics Command (NMLC), Fort Detrick, MD is the contracting activity. The requiring activity is the Naval Medical Research Unit San Antonio (NAMRU-SA), located at 3650 Chambers Pass, Building 3610, JBSA Fort Sam Houston, TX 78234 2. Description of the Action Being Approved. NAMRU-SA has a requirement for an Indefinite Delivery Indefinite Quantity (IDIQ) contract for human bone marrow derived mesenchymal stromal cells, human adipose derived mesenchymal stromal cells and human umbilical mesenchymal stromal cells. The proposed source is PromoCell GmbH, located at Sickingenstr. 63/65, 69126 Heidelberg, Germany. 3. Description of Supplies/Services. The proposed IDIQ contract will provide human bone marrow derived mesenchymal stromal cells, human adipose derived mesenchymal stromal cells and human umbilical 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 the stromal cells used in the earlier studies were. The estimated IDIQ minimum would be two (2) vials of human bone marrow-derived mesenchymal stromal cells, two (2) vials of human adipose derived mesenchymal stromal cells and two (2) vials of human umbilical mesenchymal stromal cells for a combined minimum of six (6) vials. The estimated minimum is 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 would be 30 vials of human bone marrow-derived mesenchymal stromal cells, 30 vials of human adipose derived mesenchymal stromal cells and 30 vials of human umbilical mesenchymal stromal cells for a combined maximum of 90 vials. 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 used in the earlier studies were. The cells must be frozen down at passage one (1) or earlier and aliquoted into a 1mL volume of 500,000 cells per vial because stromal cells are capable of differentiating up to passage 4. Beyond passage 4, the cells lose their differentiation ability. Because there is a need to expand out the cells to passage 3 to obtain a sufficient number of cells to differentiate at passage 4, the cells must be delivered having been frozen down at passage 1 or earlier. The cells must 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 Research Development Testing and Evaluation (RDT&E) funds. 4. Estimated Dollar Value. The estimated value of each of the base and option ordering periods is up to $56,390.00. This estimated price includes shipping costs for up to 5 shipments. The total estimated contract value is $281,950.00. The flat rate price for packaging and delivery per shipment is $52. 5. Statutory Authority Permitting Other Than Full and Open Competition. 41 U.S.C. 1901, (as implemented by FAR 13.501); Brand Name Only 6. Rationale Justifying Use of Cited Statutory Authority. Market research was conducted by the Subject Matter Experts (SME, CDR Sheppard and Dr. Alexander Burdette) at NAMRU-SA. 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 cells 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 PromoCell 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. PromoCell was the sole supplier of stromal cells to the earlier studies. No stromal cells except those provided by the same company (PromoCell) 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. PromoCell 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 companys 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 PromoCell 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 these 3 cell types from PromoCell differentiate into osteoblasts. Therefore, all 3 cell types being compared in this project must be obtained from PromoCell in order to complete the project with consistency and continuity with the previously collected data. Market research determined that Promocell has two authorized distributors: VWR International, LLC and Fisher Inc. Based on the information attained during market research, this J&A is being executed to limit offers to those of the manufacturer and authorized distributors that can provide the brand name product that is the sole product that will meet the Governments requirement. 7. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable. NMLC will synopsize this requirement on the FedBizOpps website (FBO.gov) with a combined synopsis / solicitation. In accordance with FAR 13.501(a)(1)(iv) and FAR 5.102(a)(6), because this solicitation will restrict proposals to those of the manufacturer (Promocell) and their authorized distributors (VWR International, LLC and Fisher Inc), NMLC will post a redacted copy of this J&A with the combined synopsis / solicitation. 8. Determination of Fair and Reasonable Cost. The Contracting Officer will perform a price analysis in order to determine that the anticipated cost to the Government of the services covered by this J&A will be fair and reasonable. 9. Actions to Remove Barriers to Future Competition. For the reasons set forth in Paragraph 6, (NMLC) has no plans at this time to solicit for future contracts for the type of supplies covered by this document using full and open competition. If another potential source emerges, (NMLC) will assess whether competition for future requirements is feasible. If future requirements exist that do not involve the same research efforts, the government will solicit through full and open competition to remove barriers. 10. Contracting Point of Contact. The point of contact at Naval Medical Logistics Command is Jennifer M. Reed, Code 05, (301) 619-1200 or by e-mail at Jennifer.m.reed20.civ@mail.mil.|**|TO PromoCell BioScience Alive GMBH BioMedIz, Sickingenstr. 63-65, Heidelberg, 69126, GermanyJUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN COMPETITION 1. Contracting Activity. The Naval Medical Logistics Command (NMLC), Fort Detrick, MD is the contracting activity. The requiring activity is the Naval Medical Research Unit San Antonio (NAMRU-SA), located at 3650 Chambers Pass, Building 3610, JBSA Fort Sam Houston, TX 78234 2. Description of the Action Being Approved. NAMRU-SA has a requirement for an Indefinite Delivery Indefinite Quantity (IDIQ) contract for human bone marrow derived mesenchymal stromal cells, human adipose derived mesenchymal stromal cells and human umbilical mesenchymal stromal cells. The proposed source is PromoCell GmbH, located at Sickingenstr. 63/65, 69126 Heidelberg, Germany. 3. Description of Supplies/Services. The proposed IDIQ contract will provide human bone marrow derived mesenchymal stromal cells, human adipose derived mesenchymal stromal cells and human umbilical 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 the stromal cells used in the earlier studies were. The estimated IDIQ minimum would be two (2) vials of human bone marrow-derived mesenchymal stromal cells, two (2) vials of human adipose derived mesenchymal stromal cells and two (2) vials of human umbilical mesenchymal stromal cells for a combined minimum of six (6) vials. The estimated minimum is 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 would be 30 vials of human bone marrow-derived mesenchymal stromal cells, 30 vials of human adipose derived mesenchymal stromal cells and 30 vials of human umbilical mesenchymal stromal cells for a combined maximum of 90 vials. 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 used in the earlier studies were. The cells must be frozen down at passage one (1) or earlier and aliquoted into a 1mL volume of 500,000 cells per vial because stromal cells are capable of differentiating up to passage 4. Beyond passage 4, the cells lose their differentiation ability. Because there is a need to expand out the cells to passage 3 to obtain a sufficient number of cells to differentiate at passage 4, the cells must be delivered having been frozen down at passage 1 or earlier. The cells must 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 Research Development Testing and Evaluation (RDT&E) funds. 4. Estimated Dollar Value. The estimated value of each of the base and option ordering periods is up to $56,390.00. This estimated price includes shipping costs for up to 5 shipments. The total estimated contract value is $281,950.00. The flat rate price for packaging and delivery per shipment is $52. 5. Statutory Authority Permitting Other Than Full and Open Competition. 41 U.S.C. 1901, (as implemented by FAR 13.501); Brand Name Only 6. Rationale Justifying Use of Cited Statutory Authority. Market research was conducted by the Subject Matter Experts (SME, CDR Sheppard and Dr. Alexander Burdette) at NAMRU-SA. 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 cells 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 PromoCell 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. PromoCell was the sole supplier of stromal cells to the earlier studies. No stromal cells except those provided by the same company (PromoCell) 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. PromoCell 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 companys 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 PromoCell 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 these 3 cell types from PromoCell differentiate into osteoblasts. Therefore, all 3 cell types being compared in this project must be obtained from PromoCell in order to complete the project with consistency and continuity with the previously collected data. Market research determined that Promocell has two authorized distributors: VWR International, LLC and Fisher Inc. Based on the information attained during market research, this J&A is being executed to limit offers to those of the manufacturer and authorized distributors that can provide the brand name product that is the sole product that will meet the Governments requirement. 7. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable. NMLC will synopsize this requirement on the FedBizOpps website (FBO.gov) with a combined synopsis / solicitation. In accordance with FAR 13.501(a)(1)(iv) and FAR 5.102(a)(6), because this solicitation will restrict proposals to those of the manufacturer (Promocell) and their authorized distributors (VWR International, LLC and Fisher Inc), NMLC will post a redacted copy of this J&A with the combined synopsis / solicitation. 8. Determination of Fair and Reasonable Cost. The Contracting Officer will perform a price analysis in order to determine that the anticipated cost to the Government of the services covered by this J&A will be fair and reasonable. 9. Actions to Remove Barriers to Future Competition. For the reasons set forth in Paragraph 6, (NMLC) has no plans at this time to solicit for future contracts for the type of supplies covered by this document using full and open competition. If another potential source emerges, (NMLC) will assess whether competition for future requirements is feasible. If future requirements exist that do not involve the same research efforts, the government will solicit through full and open competition to remove barriers. 10. Contracting Point of Contact. The point of contact at Naval Medical Logistics Command is Jennifer M. Reed, Code 05, (301) 619-1200 or by e-mail at Jennifer.m.reed20.civ@mail.mil.

Original Point of Contact

POC Jennifer M. Reed, Phone: 3016191200, Thomas L. Hood, Phone: 3016198894

Place of Performance

Link: FBO.gov Permalink
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