Atch_SOW_NEC.pdf

Contract No. FA5209-14-C-0018 Solicitation No. FA5209-14-R-0025

Attachment

STATEMENT OF WORK

FOR

DEPARTMENT OF THE ARMY

RESEARCH, DEVELOPMENT AND ENGINEERING COMMAND

INTERNATIONAL TECHNOLOGY CENTER-PACIFIC

(ITC-PAC)

NEC Rapid DNA System Enhancement and Validation Studies

(Document No. W90GQZ-40150016)

1. PROGRAM SCOPE/OBJECTIVES.

Rapid, portable DNA profiling is required by the United States Special Operations Command (USSOCOM) Sensitive Site Exploitation (SSE) Program to support identity intelligence operations that identify persons of interest for evidentiary, prosecution, and intelligence purposes. Recently, a rapid DNA technology developed by NEC Corporation (NEC) has matured to the point that it may be able to meet USSOCOM and other agency requirements.

NEC's rapid DNA device is one of the most recent and promising developments in this area.

Multiple organizations are coordinating to evaluate the device's capabilities. The SSE Program has partnered with the Rapid Capabilities Insertion (RCI) Program Management Office (PMO), Defense Forensic Science Center (DFSC, US Army) and the US Army International Technology Center-Pacific (ITC-PAC) to test and further NEC's portable DNA technology.

This program consists of three phases that combine foreign comparative test (FCT) and research and development (R&D) funds. Phase I evaluates the current NEC rapid DNA device. Phase II develops and incorporates front-end automation appropriate for a field environment. Phase III will evaluate the modified device in an appropriate environment.

NEC shall provide rapid DNA System Enhancement and Validation Studies and equipment design and modification activities as defined in this Statement of Work.

1.1. Requirements.

This three-phased effort shall test NEC's rapid DNA device capability, include a developmental effort to incorporate an automated cell lysis and lysate injection mechanism into the NEC portable DNA device, and finally validate modified rapid DNA configuration.

1.1.1. Phase I - Evaluate NEC's rapid DNA device in the current configuration.

The evaluation shall be conducted under the guidance and supervision of the Defense Forensic Science Center (DFSC, US Army).

1.1.2. Phase II - Develop and incorporate appropriate automation to eliminate the manual step associated with the cell lysis and lysate injection. At the end of this phase, the Contractor shall make a fully functional, modified NEC portable DNA device available for government evaluation at a To Be Determined site and facility.

1.1.3. Phase III- Evaluate the modified device in an appropriate environment. To include testing and validating the performance of the modified NEC portable DNA device with the incorporation of the automated cell lysis and lysate injection steps.

NEC rapid DNA System Enhancement Effort POC for NEC:

Mr. Yukinobu Kimoto Manager NEC Corporation 7-1, Shiba 5-chome, Minato-Ku, Tokyo 108-8001, Japan Tel+81 3 3798 2893 Email: y-kimoto@cp.jp.nec.com

1.2. Tasks.

Phase I, the Contractor shall conduct field evaluation of the NEC DNA portable device in Forest Park, GA. Phase II, shall conduct research, development, integration, and test activities to eliminate the manual step associated with the cell lysis and lysate injection steps. Phase III, shall conduct field evaluation and validation testing of the modified NEC DNA portable device in Forest Park, GA.

1.2.1. Phase I Task: Field evaluation at the DFSC in Forest Park Georgia - 15 day trip.

Thirty days (30) after the contract is signed and based on DFSC staff availability, testing of the currently developed NEC portable device in its current configuration shall occur. Activities related to a successful Phase I test include, but are not limited to, the following: reagents, supplies and equipment for the processing of 20 reference swabs, preparing and shipping device (including all logistics and fees), conducting field evaluation in Forest Park, GA, and the travel and personnel costs associated with this phase.

DFSC will provide the 20 reference swabs for testing in Forest Park, GA. During Phase I testing, the device must demonstrate a minimum of 80% of loci called correctly for the 20 samples processed, with the objective success rate being 90%. The success rate will be calculated as the number of loci with fully correct allele calls out of the total possible number of loci. The processing time for each sample must be less than 60 minutes.

DFSC will evaluate the data, along with NEC, and DFSC will calculate the success rate when compared to profiles generated by conventional laboratory DNA profiling methods.

1.2.2. Phase II Task: Research, development, integration, and test efforts to incorporate automation into the NEC DNA portable device to eliminate the manual step associated with the cell lysis and lysate injection steps. Phase II effort shall include developing and producing prototype chips for the new process.

At the conclusion of Phase II, the Contractor must demonstrate to the US Government at NEC facilities three (3) successful runs incorporating the automated cell lysis and lysate injection steps. Phase II effort shall be completed and demonstrated six (6) months after the contract is signed.

1.2.3. Phase III Task: Field evaluation and test evaluation at the DFSC in Forest Park Georgia – 15-day trip.

Testing of the enhanced NEC portable device (configuration with the automated cell lysis and lysate injection steps) shall occur approximately 50 days after the Phase II demonstration. Phase III dates are dependent on DFSC staff availability. The Contractor shall prepare and ship the enhanced device, ensure the device is set-up, calibrated, etc., prior to the start of the evaluation, and have the appropriate technical representatives on-site at Forest Park, GA, to support the conduct of this evaluation to include processing and assessment of no less than 20 reference swabs.

DFSC will provide the 20 reference swabs for testing in Forest Park, GA. During Phase III testing, the device must demonstrate a minimum of 80% of loci called correctly for the 20 samples processed, with the objective success rate being 90%. The success rate will be calculated as the number of loci with fully correct allele calls out of the total possible number of loci. The processing time for each sample must be less than 60 minutes.

DFSC will evaluate the data, along with NEC, and DFSC will calculate the success rate when compared to profiles generated by conventional laboratory DNA profiling methods.

1.3. Deliverables.

The Contractor shall submit five (5) deliverables associated with this contract.

1.3.1. First Deliverable (Phase I) – Project proposal

The Contractor shall submit a Project Proposal to ITC-PAC prior to the start of the project.

Project Proposal shall include, at a minimum, the following information:

• Description of the project

• Stages of work in the project

• Estimated expenses required for the project

1.3.2. Second Deliverable (Phase I) - Interim Report

The Contractor shall submit the Interim Report to SSE Program Office and ITC- PAC with all the results, problems and/or discoveries within 30 days after testing and evaluation (Phase I) in Forest Park, GA.

The Interim Report shall include, at a minimum, the following information:

• Project title

• Investigators

- Name

- Position title

- Organization name

- Address

- Telephone number

- Fax number

- Email address

• Detailed description of the testing and evaluation effort at DFSC.

• DNA profile data and time-to-result for the 20 reference swabs processed at the DFSC.

1.3.3. Third Deliverable (Phase II) - Interim Report

The Contractor shall submit the Interim Report to SSE Program Office and ITC- PAC with all the results, problems and/or discoveries within 30 days after the research and development effort (Phase II) at NEC facilities.

The Interim Report shall include, at a minimum, the following information:

• Project title

• Investigators

- Name

- Position title

- Organization name

- Address

- Telephone number

- Fax number

- Email address

• Summary (or abstract) of the R&D effort

• Technical details and data associated with the automated cell lysis and lysate injection steps.

• Conclusions

1.3.4. Fourth Deliverable (Phase III) - Interim Report

The Contractor shall submit the Interim Report to SSE Program Office and ITC-PAC with all the results, problems and/or discoveries within 30 days after testing and evaluation (Phase III) in Forest Park, GA.

The Interim Report shall include, at a minimum, the following information:

• Project title

• Investigators

- Name

- Position title

- Organization name

- Address

- Telephone number

- Fax number

- Email address

• Detailed description of the testing and evaluation effort at DFSC.

• DNA profile data and time-to-result for the 20 reference swabs processed at the DFSC.

1.3.5. Fifth Deliverable - Final Technical Report

The Contractor shall submit a Final Report to SSE Program Office and ITC-PAC with all the results, problems and/or discoveries encountered during the project phases within 3 months after the completion of the Phase III testing effort at DFSC.

The Final Report shall include, at a minimum, the following information:

• Project title

• Investigators

- Name

- Position title

- Organization name

- Address

- Telephone number

- Fax number

- Email address

• Summary (or abstract) of the project

• Technical details and data associated with Phase I, II, and III efforts.

• Conclusions

1.4. Financial Report

Together with the Final Report, the Contractor shall deliver the Financial Report of the Project to

ITC-PAC.

The Financial Report shall include the cost spent for the Project in the following category:

Labor Cost, Overhead, and direct Cost (Equipment, Travel, Material & Supply, Publication & Report, Computer Service).

1.5. PAYMENTS.

1.5.1. 1st Payment.

After ITC-PAC’s acceptance of a Project Proposal mentioned above (First Deliverable), the Contractor shall submit the first invoice to ITC-PAC. The first payment will be made upon ITC- PAC’s certification of the invoice. The amount of this 1st payment shall be $20,000.

1.5.2. 2nd Payment.

After ITC-PAC’s acceptance of the Second Deliverable mentioned above, the Contractor shall submit the invoice to ITC-PAC. The 2nd payment will be made upon ITC-PAC’s certification of the invoice. The amount of this 2nd payment shall be $30,000.

1.5.3. 3rd Payment.

After ITC-PAC’s acceptance of the Third Deliverable mentioned above, the Contractor shall submit the invoice to ITC-PAC. The 3rd payment will be made upon ITC-PAC’s certification of the invoice. The amount of this 3rd payment shall be $60,000.

1.5.4. 4th Payment.

After ITC-PAC’s acceptance of the Fourth Deliverable mentioned above, the Contractor shall submit the invoice to ITC-PAC. The 4th payment will be made upon ITC-PAC’s certification of the invoice. The amount of this 4th payment shall be $46,000.

1.5.5. Final Payment.

After ITC-PAC’s acceptance of the Fifth Deliverable mentioned above, the Contractor shall submit the invoice to ITC-PAC. The 5th payment (Final payment) will be made upon ITC- PAC’s certification of the invoice. The amount of this 5th payment shall be $20,000.

2. PROGAM MANAGEMENT.

NEC shall designate a single program management point of contact. The Contractor shall develop management plans to ensure that all elements of this effort are successfully executed within the program budgets and schedules.

2.1. REVIEW/MEETINGS.

NEC shall arrange a kick-off meeting, via teleconference with the SSE Program Office, DFSC, and, ITC-PAC. At the completion of Phase II, NEC shall also arrange for a demonstration of the enhanced prototype at NEC facilities.

2.2. PROGRAM TRACKING

NEC shall maintain a record of the program schedule, action items, problem areas, and problem resolutions. NEC shall also ensure that complete financial accountability is maintained.

2.3. REPORTING REQUIREMENTS.

NEC shall notify the US Government of program issues that may impact the execution of this SOW. The Contractor shall provide monthly performance reports to the SSE Program Office and ITC-PAC to include scheduled/accomplished milestones, status of ongoing efforts, project execution costs and any program issues which could impact program cost, schedule, or performance. Technical reports and test reports as listed in paragraph 1.4. will be provided to the US Government for each phase. NEC shall provide a funding schedule to meet report requirements.

2.4. SAFETY REQUIREMENTS.

N/A.

2.5. TRAINING REQUIREMENTS.

No training will be provided to NEC by US Special Operations Command, DFSC, and/or ITC-

PAC.

2.6. GOVERNMENT FURNISHED ITEMS.

Twenty (20) reference swabs for processing and analysis during Phases I ~ III at DFSC in Forest Park, GA.

2.7. FACILITIES.

DFSC will provide the facility in Forest Park, GA (United States) for Phases I and III test and evaluation efforts.

2.8. DATA/SAMPLES

NEC shall provide all consumables and equipment associated with the effort. NEC shall provide test data as listed in paragraph 1.4. DNA samples and test data produced during Phase I and Phase Ill testing is the property of the US government. Data produced during Phase I and Phase III testing cannot be used by NEC for advertising/marketing purposes and the data cannot be disseminated outside the deliverables detailed in paragraph 1.4.

3. SCHEDULE.

3.1. Phase I testing shall occur approximately 30 days after contract is signed.

3.2. 30 days after Phase I is completed an interim report is due to SSE Program Office and ITC-

PAC.

3.3. Phase II shall occur approximately 180 days after contract is signed: Final design of automated lysate step will be demonstrated to US government personnel at NEC facilities in Tokyo.

3.4. 30 days after US government demonstration of Phase II enhancements an interim report is due to SSE Program Office and ITC-PAC.

3.5. Phase III testing shall occur approximately 50 days after the Phase II demonstration.

3.6. 30 days after Phase III is completed an interim report is due to SSE Program Office and

ITC-PAC.

3.7. Approximately three (3) months after the completion of Phase III testing, a final report is due to the SSE Program Office and ITC-PAC.

4. GOVERNEMNT POCS.

- DPM-SSE: Jessica Fritz, Deputy Program Manager, 813-826-7487, Jessica.Fritz@socom.mil

- DFSC: Brigid O'Brien, Research Scientist, 404-469-7237, brigid.f.obrien.civ@mail.mil and Karen Olson, 404-469-7237, karen.e.olson7.ctr@mail.mil

- ITC-PAC: Tommy Wong, Director, Biotechnology and Nanotechnology, +81-(0)3-6385- 3335, tommy.k.wong.civ@mail.mil

5. GOVERNMENT FURNISHED PROPERTY.

No.

6. GENERAL INFORMATION.

6.1. Contractor Employees. Personnel shall meet or exceed the following requirement:

6.1.1. The Contractor shall not hire employees of the United States Government and/or employees otherwise under contract for service to the United States Government if employing such persons would create a conflict of interest, or appearance of a conflict of interest as determined by the Contractor. The Contractor shall not employ any person who is an employee of DoD, unless such person seeks and receives approval according to DODR 5500.7, Standards of Conduct.