PREPARE-BAA-Attachment_3_SOW.docx

Statement of Work Template Guide Proposers are required to submit a Statement of Work (SOW) that provides a clear, concise outline of the work performed during the proposed effort, the milestones, and the deliverables to be agreed upon between DARPA and the proposer. Proposers are strongly encouraged to use this template as it highlights the technical areas and requirements described in the BAA, aligns to the budget template, and is organized to include the appropriate level of detail over three hierarchical levels: Categories, Tasks, and Subtasks.

Categories should consist of Technical Areas (TA), Platform Integration, Capability Demonstrations, Informatics and Data Sharing, and Regulatory Engagement. Each of these Categories will be comprised of high-level Tasks that are required to accomplish Category goals. Each Task will be comprised of Subtasks that describe the specific, technical work performed to accomplish Task goals. It is the proposers’ responsibility to identify the appropriate number of Tasks and Subtasks that are necessary to meet the goals of the program.

All Tasks and Subtasks must include start and end months in relation to the beginning of the program. For example, a task or subtask with a six-month duration beginning the first day of the effort should be labeled “Start: Month 1, End: Month 6.”

Instructions for Section C Section C should be written in a concise manner and must not exceed 10 pages (Times New Roman, 12-pt font, single-spaced, normal margins). Do NOT use any pronouns. Refer to your institution and subs collectively as “the contractor.” Identify all tasking containing human or animal subject research with “This task contains Human subject research” or “This task contains animal subject research.” Colors should be removed from final submission, as well as these instructions.

STATEMENT OF WORK

<<insert Proposer Organization>> <<insert PI name>> <<insert BAA control number>>

STATEMENT OF WORK

Title – <<Insert Proposal Title>>

A. SCOPE

Provide draft language with the expectation that it will be finalized by DARPA and proposer during contract negotiations. This section should:

1. Describe the overarching goal of the project (1-2 sentences)

2. Outline the approach for each technical area (2-3 sentences each)

3. Describe the major outcomes or deliverables expected at the end of the period of performance (1-2 sentences each)

4. Address the path to regulatory approval (1-2 sentences) Unique aspects of the Capability Demonstrations may be described succinctly to indicate the anticipated threat challenges and animal models (2-3 sentences each).

A.1. BACKGROUND

Provide draft language with the expectation that it will be finalized by DARPA and proposer during contract negotiations. This section should resemble the introduction section of a research manuscript. It should (a) provide scientific and technical context that supports both the technical merit and the DoD relevance of the proposal, and (b) summarize the information included in the proposal, but not duplicate it. Figures, graphs, tables, and datasets should not be included in this section. Section A.1 may not exceed 1 page (Times New Roman, 12-pt font, single-spaced, standard margins).

B. APPLICABLE DOCUMENTS

(a) HR001117SXXXX-PREPARE

(b) <<Organization>> Proposal Titled “<<Proposal Title>>” dated <<submission date>>.

C. PROJECT WORK DESCRIPTION AND REQUIREMENTS

The Contractor shall provide the facilities and equipment necessary to develop the effort as described herein.

Provide draft language with the expectation that it will be finalized by DARPA and proposer during contract negotiations. This section should address expectations of the proposer to meet DARPA and BAA requirements.

Animal use is anticipated in this effort. The contractor shall obtain all necessary Institutional Animal Care and Utilization Committee (IACUC) approval and demonstrate this approval to the Government prior to beginning experimentation with animals. If animal use is no longer anticipated, or changes significantly from the approved IACUC then the Principal Investigator (PI) must submit a letter stating the discontinuation of animal use for this effort and/or receive appropriate authorization for IACUC changes of previously specified protocols. Unless prior approval by DARPA is given, IACUC documentation must be provided prior to award.

Activities to address Ethical, Legal, and Social Issues (ELSI) are anticipated in this effort. The Recipient shall support ELSI activities with DARPA including semi-annual teleconference calls with the ELSI Panel and regular feedback from the Panel regarding the performer’s activities. ELSI activities will be reported regularly to DARPA.

BASE PERIOD (PHASE I)

CATEGORY 1

Task 1: [Title]; [Start: Month X, End Month: Z] Describe the goal of the Task (2-4 sentences). Each task or subtask should begin with “The contractor shall...”

Subtask 1.1: [Title]; [Performing institution(s)]; [Start: Month X, End: Month Y] Describe specific efforts (e.g., experiments) required to achieve Task goal (1-2 sentences).

Milestone 1.1: [End: Month Y] Describe how success will be measured in this Subtask (1 sentence).

Metrics/Completion Criteria 1.1:

Outline specific, quantitative metric(s) to demonstrate successful Milestone completion (1-2 sentences).

Deliverables 1.1:

Describe the final technical achievement(s), product(s), etc. that are generated during this Task (1-2 sentences).

CATEGORY 2 [Insert additional categories as needed.]

OPTION PERIOD (PHASE II)

CATEGORY 1

Task 1: [Title]; [Start: Month X, End Month: Z] Describe the goal of the Task (2-4 sentences). Each task or subtask should begin with “The contractor shall...”

Subtask 1.1: [Title]; [Performing institution(s)]; [Start: Month X, End: Month Y] Describe specific efforts (e.g., experiments) required to achieve Task goal (1-2 sentences).

Milestone 1.1: [End: Month Y] Describe how success will be measured in this Subtask (1 sentence).

Metrics/Completion Criteria 1.1:

Outline specific, quantitative metric(s) to demonstrate successful Milestone completion (1-2 sentences).

Deliverables 1.1:

Describe the final technical achievement(s), product(s), etc. that are generated during this Task (1-2 sentences).

CATEGORY 2 [Insert additional categories as needed.]

D. PROGRAM MANAGEMENT AND REVIEW

Provide draft language with the expectation that it will be finalized by DARPA and proposer during contract negotiations. This section should address expectation of the proposer to meet DARPA and BAA requirements.

The Government will actively monitor, review, and approve the Contractor's performance to ensure the performers are in sync and matched with the Government's requirements. At the Government PI meeting, all performers shall demonstrate their technical capabilities and engage or challenge each other in a cooperative and challenge environment. Along these lines, the Government will ensure that the performers each share technical information with each other, as appropriate, to enable the testing/challenging of each other's capabilities. The Government will further oversee the program and will review, approve, and participate in the demonstrations, as well as determine which performers will advance to the Option Period (Phase II).

Academic contractors considered to be conducting fundamental research on this program may publish papers describing scientific or engineering advances that are general in nature and adhere to the above guidance. Should the character of the research change during award performance so that the research is no longer considered fundamental, the award will be modified to impose the restrictions on public release and dissemination of information that apply to those research efforts that are not considered fundamental research. Non-academic performers shall submit any publications to DARPA’s Public Release Center (DARPA/PRC) to process for pre-publication review.

To prevent the release of sensitive technical information certain aspects of proposals may be considered Controlled Unclassified Information (CUI) and may require safeguarding or dissemination controls, pursuant to and consistent with applicable law, regulations, and government-wide policies. Performers must partition potentially sensitive tasks from non-sensitive research efforts. All performers (prime contractor and subcontractor) desiring public release of project information that may contain CUI as defined above must submit a request for public release from DARPA/PRC in accordance with contractual requirements.

D.1. Informatics and Data Sharing Sharing of data and methods for information processing is a material requirement of the agreement. The Contractor shall support data sharing including sharing of raw and processed experimental data, processing methods used, algorithms used to process the data, artifact information, research reports, and software including source code and executables. The Contractor shall deliver to DARPA in a form agreed upon by the PM, all the experimental data collected in this effort within four months of completion of data collection (or at a date agreed upon in the statement of work). Experimental data should be accompanied with sufficient meta-data to capture laboratory conditions, equipment, supplies/reagents, procedures and methodologies. Data sharing will be included in the project milestones and reported regularly to DARPA.

D.2. Regulatory Strategy Performers must present a detailed plan for early and continued engagement with regulators (e.g., FDA) throughout the program to discuss developing technologies and challenges in order to meet the program regulatory milestones (IND/EUA processes described above), to inform and improve the design of CDs during the program, and to facilitate the eventual translation of the tools generated for clinical use. Ideally, performers will identify the applicant for the IND/EUA submission at the time of proposal submission. In addition, although pre-EUA activities may be pursued, they should not replace efforts to develop PGM-MCM products for FDA approval through IND pathways and, where possible, IND and EUA activities should proceed in parallel. It is anticipated that some of the biologics developed under this program may qualify for the FDA Animal Rule. IND/EUA submission must be for a threat-relevant indication.

D.3. Kick-off Meeting The Contractor shall attend a kick-off meeting at a location selected by DARPA. In this meeting, the Contractor shall introduce the leads on the team, present their scope of work as well as a program management plan and financial tracking plan.

D.4. Monthly Financial Reports The Contractor shall provide monthly financial progress reports to US Department of the Interior, Interior Business Center (DOINBC), Space and Naval Warfare Systems Command (SPAWAR), and DARPA. The purpose of these reports is to provide a brief project progress and inform DARPA Program Manager of any potential issues. A template will be provided for monthly reports.

D.5. Quarterly Financial Reports The Contractor shall provide quarterly financial progress reports to the DOINBC, SPAWAR, and DARPA. The purpose of these reports is to provide a brief project progress and inform the DOINBC, SPAWAR, and DARPA of any potential issues.

D.6. Monthly Technical Reporting The Contractor shall provide monthly progress reports to DOINBC, SPAWAR and DARPA. The purpose of these reports is to present a summary of work completed by SOW tasking and milestones met, discuss any problems encountered, update the program schedule, present the program financial status, and discuss remaining work. A template will be provided for monthly reports.

D.7. Quarterly Technical Reporting The Contractor shall provide detailed technical quarterly progress reports to DOINBC, SPAWAR and DARPA. The purpose of these reports is to present a summary of work completed and milestones met; discuss any problems encountered; update the program schedule; present the program financial status; and discuss remaining work regarding technical tasks, data sharing, and ELSI activities. Quarterly reports shall also include all technical data items generated under this agreement but not limited to experimental data; processed data, along with methods of processing used; research reports and publications; and software (source code and executables). A template will be provided for quarterly reports.

D.8. PI Meetings DARPA will actively engage with and manage the performer teams throughout the project, to include program level meetings and site visits held every 6 months for the program duration.

All PREPARE performer teams will participate in the program review meetings by sharing their accomplishments to date as well as the planned work for the next six-month period. Program review meetings may be attended by other performer teams or U.S. Government stakeholders at the discretion of the DARPA Program Manager.

The Contractor shall host annual site visits of DOINBC, SPAWAR and DARPA. The purpose of this visit is to present a summary report of all work completed and milestones accomplished and to discuss ongoing or future technical tasks, data sharing, and ELSI activities.

D.9. Final Contract/Cooperative Agreement Review The Recipient shall prepare and deliver a final contract report that completely and clearly describes all work completed, the results obtained and the implications of those results. The contractor shall discuss milestones accomplished and relevant and/or related future efforts which may be pursued. The Recipient shall provide a copy of the final report to DOINBC, SPAWAR, and DARPA.

E. GOVERNMENT FURNISHED EQUIPMENT (GFE) / CONTRACTOR ACQUIRED PROPERTY (CAP)

Leave blank - Will be finalized by DARPA and proposer during negotiations.

F. TRAVEL

Travel is anticipated for meetings between collaborators, meetings with DARPA, and to professional conferences to include annual PI meetings, ELSI activities, and annual site visits.

G. PLACE OF PERFORMANCE

<<Insert prime institution name and address>>

<<Insert subcontractor institution name and address>>

H. SECURITY

This work is unclassified.