Sole_Source_J&A_REDACTED.pdf

ADVFY19RD100045 Log Number: 19-10023

Form 02.4G.AB 18 Apr 2016

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a

“Justification for other than full and open competition.”

This Justification and Approval (J&A) is executed by the Naval Medical Logistics Command (NMLC), Maryland, on behalf of the requesting activity, Naval Medical Research Unit-San Antonio (NAMRU-SA, located in San Antonio, TX).

2. Nature and/or description of the action being approved.

Award of an Indefinite Delivery-Indefinite Quantity (IDIQ) contract, on a sole source basis, for the delivery of up to 625 healthy male Yucatan swine and 620 healthy male/female Hanford swine during a 60 month ordering period. The proposed source is Sinclair BioResources, 562 State Road DD, Auxvasse, MO 65231-1012.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

NAMRU-SA has a requirement for an Indefinite Delivery, Indefinite Quantity (IDIQ) contract that provides for the delivery of up to 625 healthy male Yucatan swine varying in age and weight (20-80 kgs) and 620 healthy male/female Hanford swine also varying in age and weight (12-56 kgs). NAMRU-SA is currently conducting research in support of various protocols using Yucatan and Hanford swine. Due to the continued research efforts, the continued use of the same species of swine used in current studies is required. The swine shall be healthy, disease free, raised in environmentally controlled facilities, Swine Leukocyte Antigen (SLA) tested (used in matching donor and recipient during research efforts) and shipped within one (1) SLA mismatch. A closer SLA match and similarity in immunological profiles between donor and recipient will lead to a dampened immune system response, thereby decreasing the risk of immunological rejection. (An equivalency to human transplantation requires the donor and recipient to be within one SLA mismatch.) The swine shall be at the required weight in 100% of the ordered quantities in each delivery. If any shipment does not comply with these specifications, the entire shipment shall be replaced at no cost to the Government. The animal facility shall possess a valid United States Department of Agriculture (USDA) approved Class A animal breeder license. Shipments of animals should be transported in closed climate-controlled vehicles to prevent exposure to outside air and extreme temperatures that may have an adverse effect on the animals.

The requirement shall conform to standards of environment, care and handling of animals as developed by the current supplier to avoid the skewing of data in ongoing research efforts. NAMRU-SA requires the ability to order from a range of weights or either sex of the swine. The ordering period for this IDIQ contract is anticipated to be a total of 60 months. Delivery locations will be specified at the delivery order level.

4. An identification of the statutory authority permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 41 U.S.C. 1901 (see also FAR 13.501(a)).

5. A Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

This is not a new requirement. Market research indicates that Sinclair BioResources is the only source capable of providing both the Yucatan and Hanford species of swine at the specified age and weight ranges, respectively. It is necessary to continue the use of the same species of swine to provide consistency of data. Use of other species will void the previous body of research as a means of historical data. Further, Sinclair BioResources is the only source with the capability to perform SLA testing and provide swine with the same genetic makeup that is required to provide consistency in the data to ensure that historical controls and data can be utilized and analyzed from previous projects.

The delivery of these swine will enable NAMRU-SA to continue research efforts performed under contract N62645- 15-D-5041 (awarded to Sinclair BioResources, LLC on 30 July 2015). NAMRU-SA has been utililzing Sinclair BioResources as a source for the required swine in support of ongoing scientific research efforts to increase the rate of successful transplantation of materials. Swine animal models have been be tested for SLA, which is an important method in matching donor and recipient. A closer SLA match and similarity in immunological profiles between donor and recipient will lead to a dampened immune system response, thereby decreasing the risk of immunological rejection. (An equivalency to human transplantation requires the donor and recipient to be within one SLA mismatch.)

The goal of this research is to find ways to alter the immunological response of the of the animal model after transplantation. If the animal model immunological response is to not recognize the transplanted material as foreign, the results would be favorable as the material may not be rejected. The acceptance of the transplanted material would reduce the requirement for toxic immunosuppressant medications (which are otherwise required to damp down the inevitable rejection). These findings will be translated into humans and will have profound benefits by reducing the risks associated with transplantation. Utilizing an alternate source for the required swine will result in inconsistent data analysis when comparisons are made to the prior body of research. It is imperative that the utilization and comparison of data remain consistent throughout ongoing research efforts. This is critital to the integrity of the study in its entirety.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

This requirement will be synopsized via a Notice of Intent (NOI) to Sole Source on the Federal Business Opportunities (FedBizOpps) website for 15 days. If another company submits a written interest in this requirement as a result of the announcement, the companys information will be evaluated to determine whether to conduct a competitive procurement or to proceed with a sole source contract.

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

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. A description of the market research conducted (see Part 10) and the results, or a statement of the reason market survey was not conducted.

Market research was conducted to ascertain if the required swine could be obtained as commercial items and the number of vendors in the marketplace that could meet the Government’s requirement. Market research determined that the swine could be obtained on the commercial marketplace. This is not a new requirement and the resulting contract award is intended to support ongoing research efforts performed under contract N62645-15-D-5041 (award to Sinclair BioResources, LLC on 30 July 2015).

As part of market research, three vendors were contacted (through their website and/or by email) to determine if they could provide delivery for 625 healthy male Yucatan swine varying in age and weight (20-80 kgs) and 620 healthy male/female Hanford swine also varying in age and weight (12-56 kgs) over a 60 month ordering period.

The first source contacted was Stein and Stewart Genetics. Stein and Stewart Genetics were not able to meet the requirements of the Government because they cannot provide the Yucatan or Hanford species of swine. Additionally, they cannot perform the required SLA testing. Lastly, they cannot provide swine with the same genetic makeup that is required to provide consistency in the data to ensure that historical controls and data can be utilized and analyzed from previous research conducted under contract N62645-15-D-5041. Therefore, Stein and Stewart Genetics cannot be considered as a source for this requirement.

The second source that was contacted was Marshall BioResources. Marshall BioResources was not able to meet the requirements of the Government because they cannot provide the Yucatan or Hanford species of swine. Additionally, they cannot perform the required SLA testing. Lastly, they cannot provide swine with the same genetic makeup that is required to provide consistency in the data to ensure that historical controls and data can be utilized and analyzed from previous research conducted under contract N62645-15-D-5041. Therefore, Marshall BioResources cannot be considered as a source for this requirement.

The third source contacted was Sinclair BioResources. Sinclair BioResources does have the capability to meet the requirements of the Government. They are capable of providing both the Yucatan and Hanford species of swine at the specified age and weight ranges, respectively. Additionally, they have the capability to perform SLA testing as well has provide swine with the same genetic makeup that is required to provide consistency in the data to ensure that historical controls and data can be utilized and analyzed from previous projects and research conducted under contract N62645-15-D-5041.

Market research concluded that only one source was located that could meet the requirements of the Government (Sinclair BioResources).

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

None.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. Any sources expressing interest in response to the synopsis will receive consideration

11. A statement of the 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.

Future requirements will be synopsized in accordance with FAR 5.203. For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the types of supplies covered by this document. If another potential source emerges, NMLC will assess whether competition for future reuqirements is feasible.