N02RC62575-76_HHSN261201600006A-REDACTED--J_A-REDACTED.pdf

Justification and Approval for Sole Source Acquisition Under the Test Program for Commercial Items

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS, NIH

b. Sponsoring organization. National Cancer Institute (NCI),Center for Cancer Research (CCR), Surgery Branch (SB)

c. Project Officer information.

Project Officer name.

Mailing address.

Bethesda MD 20892-1201

E-mail address.

Telephone number.

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

a. Acquisition purpose and objectives. XFe96 Extracellular Flux Analyzer simultaneously measures the two major energy producing pathways of the cell (mitochondrial respiration and glycolysis) in a 96 wells microplate, in real-time. The XFe96 Analyzer determine in vitro oxygen consumption rate and extracellular acidification rate in order to assess cellular functions such as oxidative phosphorylation, glycolysis, and fatty acid oxidation. The XFe96 measures live cells bioenergetics, which enables time-resolved analysis and testing of multiple conditions per assay. The XF technology provides the tools to: Simultaneously measure oxygen consumption rate and extracellular acidification rate in 96 assay wells, rapidly detect cellular responses to substrates, inhibitors, and other inhibitors, and test more conditions with the same amount of sample, maximizing the value of each experiment. The Surgery Branch requires the Seahorse XF analyzer to perform real time metabolic analysis of T-cells. The data thus obtained is essential for ongoing and future projects listed in section 2.b.

b. Project background. Adoptive T-cell therapies using tumor infiltrating lymphocytes (TIL) has shown to induce cancer regression in ~50% of the patients. Recent studies from the Surgery Branch show that the use of younger, less differentiated cells can vastly improve the treatment efficacy in patients. T-cells have different metabolic programming during their resting and activated functional states and the Surgery Branch’s experiments indicate that the function and differentiation state of the T-cells can be regulated by restricting or altering their energy metabolites.

The Seahorse XF analyzer will provide the Surgery Branch with a scientifically significant tool to measure as well as to study the steady state metabolic profiles of cells under different treatment conditions.

Identification of the metabolic characteristics of the cells as well as the metabolic behavior of the cells under various drug treatment conditions will enable the Surgery Branch to rapidly translate our findings to the clinic wherein it can help improve T-cell based immunotherapies in cancer patients.

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

a. Project title. Seahorse XF Metabolic analyzer

b. Project description. The Surgery Branch plans to purchase the seahorse XF analyzer to monitor changes in metabolic pathways, specifically glycolysis or oxidative phosphorylation, in T-cells. The Seahorse XF analyzer’s ability to measure the real time metabolic changes will enable the Surgery Branch to interrogate the functions of several genes through either gene overexpression/down regulation in T-cells followed by real time metabolic measurements. This data will then be used to test the functional efficacy of T-cells in animals models. Genes thus identified to be important can then be eventually translated to the clinic. (As described in background section). See the Statement of Work for additional information.

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on Other (specify): ______________________

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________

Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number. N02RC62575-76

c. Total estimated dollar value and performance/delivery period.

Delivery will be within

90 days of award.

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

This acquisition is conducted under the authority of 41 United

States Code (U.S.C.) 253(c)(__) as set forth in Federal Acquisition Regulation (FAR) 6.302- __.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996, as set forth in FAR Statute:

13.106-1(b)(2) and FAR 13.501(a)(1).

This acquisition is conducted under the authority of the Services

Acquisition Reform Act of 2003 (41 U.S.C. 428a).

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

a. Name and address of the proposed contractor(s).

Seahorse Biosciences, A part of Agilent Technologies 16 Esquire Road North Billerica, MA 01862 +1.978.671.1600

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Seahorse Bioscience, Inc. is currently the only manufacturer that makes an instrument that analyze live cell bioenergetics that requires low cell number and measures 96 samples on a single read/assay.

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

A pre-solicitation notice was posted on FedBizOpps.gov on May 23, 2016 with a response date of June 1, 2016; 11:00 AM EDT. No responses were received in response to the pre-solicitation notice.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The NCI Contract Specialist will consider the Independent Government Estimate and previous purchase order prices as a determining factor for reasonableness.

Based on the aforementioned, there is no reason to believe that price will not be fair and reasonable to the Government. A final determination will be conducted prior to the award of this contract.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

The Surgery Branch has conducted extensive literature research and experiments. As a result, it has concluded that the Seahorse XF analyzer is the only commercially available system/solution for its purpose. The instrument manufactured by Seahorse Bioscience is the only instrument with the capability for live cell measurement, low cell number, simultaneously measures two major energetic pathways, and handles 96 samples in a single read.

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

No additional information.

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

No other sources have expressed an interest, in writing, in the proposed acquisition.

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

In the event that additional service is required, the NCI program office and the Contracting Officer will conduct market research to determine if the current state of technology has advanced and to determine if there are other sources available that can provide the supplies required.