J A_Memory_Scaffold_Redacted.pdf

Template 05.5G.4B 18 May 2015

J&A Number: (16-10253)

JUSTIFICATION AND APPROVAL

FOR USE OF OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity.

This Justification and Approval (J&A) is executed by the Naval Medical Logistics Command (NMLC), 693 Neiman Street, Fort Detrick, MD 21702, on behalf of the requesting agency, Naval Medical Research Unit San Antonio (NAMRU-SA), 3650 Chambers Pass, Building 3610, JBSA Fort Sam Houston, TX 78234.

2. Description of the Action Being Approved.

Award of a contract on a sole source basis will be made to provide an indefinite-delivery indefinite-quantity contract to Texas A & M University for shape memory scaffolds for a base period of 12 months, followed by two 12-month option periods for a total of 36 months;

deliveries to be scheduled at designated locations on an “as needed” basis. The proposed source is Texas A & M University (Rudder Complex, 401 Joe Routt Blvd, College Station, TX 77843)

3. Description of Supplies/Services.

The requirement is for a maximum 900 shape memory scaffolds. The scaffold must be a poly (ε-caprolactone) based scaffold which is capable of shape memory behavior (e.g. can be molded to any size with the application of warm saline) and has a porosity of ~85-90% with an elastic modulus of ~4.4MPa. Further, the shape memory scaffold must also be coated with polydopamine to enhance bioactivity and cellular binding. If necessary, upon request by NAMRU-SA, the porosity and/or elastic modulus of the shape memory scaffold will be adjusted to fit the needs of NAMRU-SA for bone regeneration. The scaffolds will be trimmed to a cylindrical disc shape with a diameter of 8mm and a thickness of 1mm and shipped in sealed 12-well plate.

The IDIQ contract will be for a base ordering period of 12 months with two 12 month options for a total ordering period (if the Government exercises all options) of 36 months. The maximum order threshold is estimated to be $124,950.00 for the base year, $117,600.00 for option year one, and $21,756.00 for option year two. The maximum ordering threshold for the 36 month period is $264,306.00.

4. Statutory Authority Permitting Other Than Full and Open Competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 USC 2304(c)(1) and FAR 13.501(a), sole source acquisitions.

5. Rationale Justifying Use of Cited Statutory Authority.

The reason for justification of use of the cited statutory authority is ongoing studies that will performed at NAMRU-SA to conduct research to test and evaluate the growth and osteogenic differentiation ability of primary stromal cells on a novel proprietary shape memory scaffold for bone regeneration. The critical aspects of the shape memory scaffold are that the scaffold can be molded to fit any defect shape or size and is highly bioactive, allowing efficient cell binding and proliferation which greatly improves osseo-integration compared to commercially available scaffolds. Subsequent studies will then be performed in large animals with the stromal cell-seeded shape memory scaffold. Market research revealed that Texas A&M University was the only vendor able to provide the poly (ε-caprolactone) based shape memory scaffold to meet the government’s specifications.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

Market research was conducted in July 2016. The market research conducted included research conducted by review of product literature, and email communication with potential vendors.

Four vendors were contacted (Texas A&M, Medtronic, Zimmerdental, and Ace Surgical Company, Inc.). Medtronic, Zimmerdental, and Ace Surgical Company, Inc.provided responses that stated that not sell and/or cannot purchase any scaffolds that fit the government’s specifications. Texas A&M University was the only vendor able to provide the poly (ε-caprolactone) based shape memory scaffold to meet the government’s specifications.

A sources sought notice was posted on 05 August 2016. No responses were received in response to this notice.

A notice of intent was posted on 27 August 2016. No responses were received in response to this notice.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer shall determine that the anticipated cost to the Government of the supplies covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined 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 contracts 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 Amanda E. Aung, Code 05, at DSN 343-3969, commercial (301) 619-3969 or by e-mail at Amanda.E.Aung.civ@mail.mil.

See Approvals on Next Page

J&A Number: 16-01150

CERTIFICATIONS AND APPROVAL

TECHNICAL/REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein, are complete and accurate to the best of my knowledge and belief.

Technical Cognizance

Requirements Cognizance

LEGAL SUFFICIENCY REVIEW

I have determined this Justification is legally sufficient.

CONTRACTING OFFICER CERTIFICATION

I certify that this Justification is accurate and complete to the best of my knowledge and belief.

APPROVAL