revised_J&A.pdf

Market research conducted by retrieving estimates from other vendors whose average price was within a 14% variance of the average cost, proving that this requirement is fair and reasonable.

8. Description of the market survey conducted and the results, or a statement of the reasons a market survey was not conducted.

I. Mabtech, Inc - POC: Fredrik Lyon, email: Fredrik.lvon(i�mabtech.com.

Phone: 1866-354-7768.Contacted by email and provided a quote for pre-coated Human IFNg/GranzymeB FluoroSpot kits

2. Cellular Technology Limited (CTL)- POC: Zsuzsanna Simon-Benedek, email:

zsuzsa.simon-bcnedek(@immunospot.com Phone: 216-791-5084 xl32. Contacted by email and provided a quote for pre-coated Human IFNg/GranzymeB FluoroSpot kits

I. Mabtech, Inc Quality Control assays performed met our specifications and we have chosen MABTECH as our preferred Vendor.

Item previously purchased in Feb 2019 HJF Order# 18816,Sep 2018 HJF Order# 17722, Aug 2016 HJF Order# 13410, F eh 2016 HJF Order# 1222, etc.

Human IFN-g/Granzyme B kits from MABTECH were used to conduct FluoroSpot immunoassays using cells from research subjects enrolled in a malaria vaccine clinical trial conducted by the NMRC in 2018. The assays conducted during the active phase of the clinical trial used fresh cells isolated from research subjects.

We plan to conduct additional assays in 2019 using cryopreserved cells obtained from the same research subjects. To reduce variability between experiments, we must use the same type (manufacturer, catalog number) of human IFN-g/Granzyme B kit and the same type of plate reader (AID reader) for the cryopreserved cells as were used for the fresh cells. Switching to another kit type/manufacturer and plate reader in the middle of a research study would require additional time and cost (added to the cost of the kits and plate reader maintenance) to conduct bridging studies with a very limited quantity of cells (from research subjects) and reagents (peptides). In addition, if we had to get a new plate reader with new computer and plate reading software we would have to restart our lengthy Defense Health Agency information technology accreditation/authorization process. Delays would result in our inability to meet research milestones. MABTECH pre-coated plates can be stored at room temperature and this is very convenient since there is very limited storage space at 4C. Plates from other manufacturers require storage at 4C.

2. Cellular Technology Limited (CTL) The pre-coated plates have to be stored at 4C along with other reagents. May require a different plate reader and software. If we had to get a new plate reader with new computer and plate reading software we would have to restart our lengthy Navy Medicine information assurance approval process. Delays would result in our inability to meet research milestones.

9. Other facts supporting the use of other than full and open competition.

(i) Explanation of why technical data packages, specifications, engineering descriptions, statements of work, or purchase descriptions suitable for full and open competition have not been developed or are not available.

(ii) When 6.302-1 is cited for follow-on acquisitions as described in 6.302-l(a)(2)(ii), an estimate of the cost to the Government that would be duplicated an,d how the estimate was derived.

(iii) When 6.302-2 is cited, data, estimated cost, or other rationale as to tire extent and nature of the harm to tire Government.

This should include previous contracts for the same supplies or services detailing tire contract number, date awarded, contract awarded amount, and whether it was procured full and open or through a sole source procurement. Any duplication of costs should be addressed.

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

For the reasons set forth in Paragraph 5, NMRC has no plans at this time to compete future contracts for the types of supplies/services covered by this document. If another potential source emerges, NMRC will assess whether competition for future requirements is feasible. If another potential source is identified, the NMRC Malaria Department would have to seek funding to conduct a bridging study.

12. Point of Contact.