Document:

EX-10.4

 Exhibit 10.4 

[***]= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 
 

 

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 Section B - Supplies or Services and Prices 

 

																	
	ITEM NO	  	SUPPLIES/SERVICES	  	QUANTITY	 	  	UNIT	 	  	UNIT PRICE	  	AMOUNT	 
	0001	  		  	 	1	  	  	 	Job	  	  		  	$	5,506,165.00	  
		  	 Proposal Log No. JW140042 6.3 Funding

CPFF
 The contractor shall furnish the necessary equipment,
personnel, facilities and supplies to conduct the research objectives in accordance with the contract schedule and the Proposal No. JW140042, requirements entitled “Advanced Development of Entolimod (CBLB502) To Mitigate and Treat the Acute
Effects of Ionizing Radiation.” which is incorporated by reference. Both SOW, dated 12 August 2015, and CDRLS A001, A002, A003 and A004 are incorporated by reference, see Section “J” for details. See Section “G” for payment
instructions. Period of Performance for research: 01 September 2015 - 31 August 2017. Final report due 90 days after research ends, 01 September 2017- 30 November 2017. This CLIN provides 6.3 Funding for research activities as specified in the SOW
dated 25 August 2015 under Specific Aim 1, Task 2, Specific Aim 2 and Specific Aim 3.
 FOB: Destination

PURCHASE REQUEST NUMBER: 0010624278-0002
	  			
		  	 ESTIMATED COST
	  	$	4,922,759.20	  
		  	 FIXED FEE
	  	$	583,405.80	  
		  		  				  				  		  	  
	  
	 
	 TOTAL EST COST + FEE
	  	$	5,506,165.00	  
		  	 ACRN AA
 CIN:
GFEBS001062427800003
	  	$	5,506,165.00	  

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	ITEM NO	  	SUPPLIES/SERVICES	  	QUANTITY	 	  	UNIT	 	  	UNIT PRICE	  	AMOUNT	 
	0002	  		  	 	1	  	  	 	Job	  	  		  	$	3,720,289.64	  
		  	 Proposal Log No. JW140042 6.4 Funding

COST
 The contractor shall furnish the necessary equipment,
personnel, facilities and supplies to conduct the research objectives in accordance with the contract schedule and the Proposal No. JW140042, requirements entitled “Advanced Development of Entolimod (CBLB502) To Mitigate and Treat the Acute
Effects of Ionizing Radiation.” which is incorporated by reference. Both SOW, dated 27 January 2015, and CDRLS A001, A002, A003 and A004 are incorporated by reference, see Section “J” for details. See Section “G” for payment
instructions. Period of Performance for research: 01 September 2015 - 30 August 2017. Final report due 90 days after research ends, 01 September 2017- 30 November 2017. This CLIN provides 6.4 Funding for the definitive non-human primate animal study
as specified in the SOW dated 12 August 2015 under Specific Aim 1 Task 1. Fee is included in CLIN 0001 as this cost is aligned with 6.3 Funding.
 FOB:
Destination
 PURCHASE REQUEST NUMBER: 0010624278-0002
	  			
		  	ESTIMATED COST	  	$	3,720,289.64	  
		  	 ACRN AB
 CIN:
GFEBS001062427800004
	  	$	3,720,289.64	  

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 [***]= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 
 Section C
- Descriptions and Specifications 
 DESCRIPTION OF RESEARCH 

Cleveland BioLabs, Inc. (CBLI) research involves the continued preclinical development of entolimod (CBLB502) as a medical radiation countermeasure (MRC) for
reducing the risk of death following total body irradiation, a cause of Acute Radiation Syndrome (ARS). There is currently no US Food and Drug Administration (FDA)-approved medical countermeasure to treat ARS. Entolimod is a novel clinical stage
drug candidate moving towards FDA approval as a safe and effective treatment for ARS. The work under the Joint Warfighter Medical Research Program will include: [***]. CBLI is the overarching sponsor for regulatory applications including FDA
applications to include Investigational New Drug (IND), Biologics License Application (BLA), and/or Emergency Use Authorization (EUA). CBLI has obtained FDA IND for entolimod under IND 100,480. The proposed studies under this SOW will provide
additional data for FDA review, and as part of CBLI’s path toward submitting a BLA for FDA approval of entolimod for ARS (for both the frozen liquid formulation and lyophilized formulation). The SOW is incorporated herein and attached at
Section J. 
 USAMRAA LOCAL INSTRUCTIONS 
 Contractor
Manpower Reporting (CMR) (USAMRAA) (May 2015) 
 “The contractor shall report ALL contractor labor hours (including subcontractor labor hours)
required for performance of services provided under this contract for “The Advanced Development of Entolimod (CBLB502) To Mitigate and Treat the Acute Effects of Ionizing Radiation” via a secure data collection site. The contractor is
required to completely fill in all required data fields using the following web address: https://cmra.army.mil/Login.aspx. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal
year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the help
desk at help desk at: 
 ARMY: https://cmra.army.mil/Login.aspx. 

All Others: https://www.ecmra.mil/. 
 CONTRACTOR
IDENTIFICATION (June 2015) (USAMRAA) 
 When contractor personnel perform the services required in this contract on a Government installation they are
required to possess and wear an identification badge that displays his or her name and the name of the Company. The contractor shall ensure that contractor personnel identify themselves as contractors when attending meetings, answering Government
telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts. 

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 While performing in a contractor capacity, contractor personnel shall refrain from using their retired or
reserve component military rank or title in all written or verbal communications. 
 KEY PERSONNEL (June 2015) (USAMRAA) 

a. The Contractor agrees to utilize the following Key Personnel on this contract: 
  

	 	1.	Dr. Andrei Gudkov, Co-PI 

	 	2.	Dr. Vadim Krivokrysenko, Co-PI 

 b. The above Key Personnel shall be utilized to fulfill the requirements
of this contract. 
 c. The contractor must provide thorough and detailed documentation of the experience, abilities, and background for Key Personnel under
this contract in the form of resumes or equivalent statements of qualifications. Such documentation shall include but not be limited to: name, curriculum vitae, type and description of experience. 

d. The contractor agrees that during the contract performance period, substitution for Key Personnel shall not be permitted unless such substitution is
necessitated by sudden illness, death, or termination of employment. In any of these events, the contractor shall promptly notify the Contracting Officer and provide the information required by paragraph (e) below. 

e. All requests for substitutions must provide a detailed explanation of the circumstances necessitating the proposed substitution(s), a complete resume for
the proposed substitute(s), and any other information requested by the Contracting Officer needed to approve or disapprove the proposed substitution(s). All proposed substitutes shall have qualifications that are equal to or higher than the
qualifications of the person to be replaced. The Contracting Officer or his authorized representative will evaluate such requests and promptly notify the contractor of his approval or disapproval thereof. 

f. If any of the listed Key Personnel are subcontractor personnel, the contractor shall include the substance of this clause in any subcontract which he awards
under this contract. 

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 Section D - Packaging and Marking 
  

	 	a.	Packing shall be standard commercial to ensure acceptance by common carriers for safest delivery to destination unless otherwise specified in the specifications of description of this items. 

 

	 	b.	All shipping or mailing containers shall be marked showing “Contract No. W81XWH-15-C-0101” and the destination address shown in Section “F.” 

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 Section E - Inspection and Acceptance 

INSPECTION AND ACCEPTANCE TERMS 
 Supplies/services will be
inspected/accepted at: 
  

									
	CLIN	  	INSPECT AT	  	INSPECT BY	  	ACCEPT AT	  	ACCEPT BY
	0001	  	Destination	  	Government	  	Destination	  	Government
	0002	  	Destination	  	Government	  	Destination	  	Government

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 Section F - Deliveries or Performance 

DELIVERIES OR PERFORMANCE 
 REPORTS, MANUSCRIPTS AND
PUBLIC RELEASES (June 2015) (USAMRAA) 
 a. Contractors are encouraged to publish results of research supported by the US Army Medical Research and
Materiel Command (USAMRMC) in appropriate media forum. Any publication, report or public release, which may create a statutory bar to the issuance of a patent on any subject invention, shall be coordinated with appropriate patent counsel. 

b. Manuscripts intended for publication in any media shall be submitted to the Contracting Officer and Contracting Officer’s Representative (COR),
simultaneously with submission for publication. Review of such manuscripts is for comment to the Principal Investigator, not for approval or disapproval. Courtesy copies of the reprint shall be forwarded to the Contracting Officer and COR, even
though publication may be subsequent to the expiration of the contract. 
 c. The Contractor shall notify the Contracting Officer of planned news releases,
planned publicity, advertising material concerning contract work, and planned presentations to scientific meetings, prior to public release. This is not intended to restrict dissemination of research information but to allow USAMRMC advance notice
in order to adequately respond to inquiries. 
 d. Manuscripts, reports, public releases and abstracts, which appear in professional journals, media and
programs, shall include the following statements: 
 (1) “This work is supported by the US Army Medical Research and Materiel Command under Contract No.
W81XWH-15-C-0101” 
 (2) “The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an
official Department of the Army position, policy or decision unless so designated by other documentation.” 
 (3) As applicable, if the research
involves the use of animals, the Contractor must include the following statement: “In conducting research using animals, the investigator(s) adhered to the Animal Welfare Act Regulations and other Federal statutes relating to animals and
experiments involving animals and the principles set forth in the current version of the Guide for Care and Use of Laboratory Animals, National Research Council.” 

(4) As applicable, if the research involves human use, the Contractor must include the following statement: “In the conduct of research where humans are
the subjects, the investigator(s) adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50
(Protection of Human Subjects).” 
 (5) As applicable, if the research involves the use of recombinant DNA, the Contractor must include the following
statement: “In conducting work involving the use of recombinant DNA the investigator(s) adhered to the current version of the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules.” 

DELIVERABLES 
 Delivery Schedule Abbreviations 

The Contractor shall provide monthly, annual and final technical reports that describe the progress made within the period, summarize projected versus actual
progress, report costs incurred, report monthly planned costs (spend plan) as well as a forecasted contract spend plan by government fiscal year (beginning OCT 1), and inform the Government of existing or potential problem areas. 

The following abbreviations are used in the delivery/deliverable schedule: 
  

			
	 Abbreviation
	  	 Definition

	ACA	  	After Contract Award
	CS	  	Contract Specialist
	COR	  	Contracting Officer’s Representative
	N/A	  	Not Applicable
	NLT	  	No Later Than
	POP	  	Period of Performance
	P/S	  	Page or Section

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 Deliverable/Delivery Schedule 

A summary of deliverables follows. The list of deliverables serves as a minimum set of contractor deliverables required to meet the intent of Section C and
other contract management deliverables. Copies are to be provided to the Government officials indicated under distribution (Dist) and in electronic file or digital medium. 
  

											
	 Item
	  	 Title
	  	 Dist
	  	 Contract Secion
	  	 Initial
	  	 Subsequent

	Deliverable 1	  	Monthly Technical Progress Reports and Teleconferences	  	 COR
 CS

CDMRP
	  	Section F	  	On the 10th day of the month ACA	  	On the 10th day of each subsequent month
	Deliverable 2	  	Quarterly Quad Charts	  	 COR
 CS

CDMRP
	  	Section F	  	On the 15th day after 1st quarter ends	  	On the 15th day after each quarter ends
	Deliverable 3	  	Annual Technical Reports	  	 COR
 CS

CDMRP
	  	Section F	  	30 days after end of Year 1	  	N/A, unless there is an award modification to the POP
	Deliverable 4	  	Final Technical Report	  	 COR
 CS

CDMRP
	  	Section F	  	90 days after research POP ends	  	N/A
	Deliverable 5	  	Report, Production, or Delivery Problems (CDRL A001)	  	 COR
 CS

CDMRP
	  	Section J	  	Within 5 day of incident by email and written summary report within 10 business days of incident	  	Within 5 day of incident by email and written summary report within 10 business days of incident
	Deliverable 6	  	FDA Communications, Study Reports, and Meetings (CDRL A002)	  	 COR
 CS

CDMRP
	  	Section J	  	Same day for outgoing correspondences to FDA; within 3 business days for receipt of FDA correspondences	  	Same day for outgoing correspondences to FDA; within 3 business days for receipt of FDA correspondences
	Deliverable 7	  	Technical Data and Study Reports(CDRL A003)	  	 COR
 CS

CDMRP
	  	Section J	  	Within 30 days upon each study completion	  	As Required
	Deliverable 8	  	Briefing Material (CDRL A004) and Teleconferences	  	 COR
 CS

CDMRP
	  	Section J	  	Within 30 days after each quarter ends and also within 60 days following completion of study	  	Within 30 days after each quarter ends and also within 60 days following completion of study
	Deliverable 9	  	DOD Review Meetings (e.g. In Progress Review, Interim Program Review, etc.)	  	 COR
 CS

CDMRP
	  	Section F	  	Upon request/invitation	  	Upon request/invitation

 MONTHLY REPORTING REQUIREMENTS 

DELIVERABLE 1: REPORTING REQUIREMENTS (OCT 2009) (USAMRAA) 

Monthly technical progress reporting requirements applicable to this award are annotated below: 

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            XX            MONTHLY
TECHNICAL PROGRESS REPORTS 
 a. The contractor shall submit a Monthly Technical Progress Report covering work accomplished during
each month of contract performance. It shall be brief, factual, and informal, and shall be prepared in accordance with the following: 
 (l)
Cover containing: 
 (a) Contract number and title 

(b) Type of report, sequence number of report, and period of performance being reported 

(c) Contractor’s name, address, and telephone number 

(d) Principal Investigator 
 (e)
Date of publication 
 (f) Contracting Officer’s Representative 

(2) Section I – Introduction and Project Summary (Purpose and Scope of Research Effort). A brief introduction covering the purpose and
scope of the research effort (one paragraph summary). 
 (3) Section II – Progress 

(a) Overall Progress Summary. A brief description of overall progress to date for the reporting period (one-two paragraphs summary). 

(b) Individual Task Progress. A separate description for each task or other logical segment of work on which effort was expended during the
report period, briefly describing the work that has been performed. Description shall include pertinent data and graphs in sufficient detail to explain any significant results achieved. List all tasks associated with the approved Statement of Work
(SOW) including those with no activity performed for the period and status stating as such (i.e. have not started, no work conducted this period, started, delayed, % completed, etc.). 

(4) Section III - Problems and Changes 

(a) Problems Encountered. A description of current problems that may impede performance, including impact on expenditures, along with proposed
corrective action. Report any changes (e.g. staff addition/removal/FTE reduction/increase, approaches, etc.) that happened and why. Note some changes require Contracting Officer’s review and expressed written approval through a formal award
modification before implementation. 
 (b) Problems Anticipated. A description of anticipated problems that have a potential to impede
progress and/or impact expenditures, and what corrective action is planned should the problem materialize. Report any changes (e.g. staff, approaches, etc.) planned and why. Note some changes require Contracting Officer’s review and expressed
written approval through a formal award modification before implementation. 
 (5) Section IV - Next Month Actions. A brief description of
work to be performed during the next reporting period for each task. If no work is planned for a task then state so and why if appropriate. 

(6) Section V - Administrative Comments - Description of proposed site visits and participation in technical meetings, journal manuscripts in
preparation, coordination with other organizations conducting related work, etc. 

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 (7) Section VI – Research Protocols and Regulatory Status 

(a) Protocol Status. List each protocol planned for the project including title, protocol identifiers (i.e. IACUC number, ACURO number, name of
regulatory review board, etc.), type of animals, number of animals, protocol PI, protocol site, etc., and note status of each (e.g. in development, submitted to regulatory agency such as IACUC, ACURO, FDA for review, approval date with name of
regulatory authority, date of continuing review or rewrite review, amendments with brief statement of the changes and its status such as submitted and/or approved by which regulatory authority, etc.) 

(b) Adverse Events. Describe any adverse events and actions taken. 

(8) Section VII - A Gantt Chart showing actual progress versus scheduled progress. 

b. Monthly Technical Progress Reports shall be prepared by the seventh day following the month being reported, and shall be received within 10
days of the report month. Filename shall include the contract award number followed by report number and year of submission (e.g. W81XWH-15-C-0101 Monthly Report#01 2015). The Monthly Technical Progress Report shall be submitted to the following
addresses: 
  

			
	One Copy:	  	 U.S. Army Medical Research Acquisition Activity (USAMRAA)

ATTN: MCMR-AAA-SB
 820 Chandler Street

Fort Detrick, MD 21702-5014
 Email:
jesse.m.hoffman2.civ@mail.mil
  

	One e-Copy:	  	 Contracting Officer’s Representative (COR)

Congressionally Directed Medical Research Programs (CDMRP)
 Email:
Eva.Lai.civ@mail.mil
  
 and

 
 Congressionally Directed Medical Research Programs (CDMRP)

Email: Usarmy.detrick.medcom-cdmrp.mbx.cdmrp-reporting@mail.mil

 DELIVERABLE 2: QUARTERLY QUAD CHART REPORTING REQUIREMENTS 

The Quarterly Quad Chart shall be prepared using the template available on USAMRAA webpage at https://www.usamraa.army.mil) and shall be received within
15 days after each quarter period ending ACA. File shall be saved as Microsoft PowerPoint. Filename shall include the contract award number followed by report type, year and quarter of submission (e.g. W81XWH-15-C-0101 Quad Chart Year 1 Quarter 1).
Electronic or digital copies shall be submitted to the same addresses as noted above. 
 ANNUAL/FINAL REPORTING 

DELIVERABLES 3 AND 4: ANNUAL/FINAL TECHNICAL REPORTING REQUIREMENTS 

Format Requirements: 
 a. Annual reports shall be
prepared in accordance with the Research Performance Progress Report (RPPR). The RPPR is the uniform format for reporting performance progress on Federally-funded research projects and research-related activities. Annual reports shall provide a
complete summary of the research results (positive or 

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negative) to date in direct alignment to the approved Statement of Work (SOW). The importance of the report to decisions relating to continued support of the research cannot be over-emphasized.
An annual report shall be submitted within 30 calendar days of the anniversary date of the award for the preceding 12 month period. If the award period of performance is extended by the USAMRAA Contracts Officer, then an annual report shall still be
submitted within 30 days of the anniversary date of the award. A final report will be due upon completion of the extended performance date that describes the entire research effort. 

b. A final report shall also be prepared in accordance with the RPPR and shall be submitted within 90 calendar days of the award performance
end date. The report shall summarize the entire research effort, citing data in the annual reports and appended publications. 
 Although there is no page
limitation for the reports, each report shall be of sufficient length to provide a thorough description of the accomplishments with respect to the approved SOW. Reports, in electronic format (PDF or Word file only), shall be submitted to
https://ers.amedd.army.mil. 
 All reports shall have the following elements, in this order: 

FRONT COVER: 
 Sample
front cover is provided at 
 http://mrmc.amedd.army.mil/index.cfm?pageid=researcher_resources.technical_reporting. The Accession Document (AD) Number
should remain blank. 
 Distribution: Reports must include one of two distribution statements: 

(1) Unlimited Distribution: If the distribution will be unlimited (i.e., approved for public release), choose the form entitled
“Award/Contract Front Cover – Unlimited Distribution A.” Results of fundamental research should be public distribution except in rare and exceptional circumstances. 

(2) Limited Distribution: If the distribution is to be limited, choose the form entitled “Award/Contract Cover – Limited Distribution
B.” After report submission, the COR will review the appropriateness of using this distribution statement. The COR has the right to challenge the validity of any restrictive markings. Reports that may be eligible for limited distribution may be
ones that contain proprietary data that is not to be released to the public. If so, mark the cover page as “Proprietary”. DO NOT USE THE WORD “CONFIDENTIAL” WHEN MARKING DOCUMENTS. The contractor shall maintain records sufficient
to justify the validity of any restrictive markings. REPORTS NOT PROPERLY MARKED WILL BE DISTRIBUTED AS APPROVED FOR PUBLIC RELEASE. 
 For additional
information regarding distribution statements, see DOD Instruction 5230.24 (available at http://www.dtic.mil/whs/directives). 
 For general
information regarding report preparation, access the Research Resources, Technical Reporting, website at https://mrmc.amedd.army.mil/index.cfm?pageid=researcher_resources.technical_reporting. 

STANDARD FORM 298: Sample SF 298 is provided at 

http://mrmc.amedd.army.mil/index.cfm?pageid=researcher_resources.technical_reporting. The abstract shall be provided in Block 14 and shall state the
purpose, scope, and major findings and be an up-to-date report of the progress in terms of results and significance. Abstracts will be submitted to the Defense Technical Information Center (DTIC) and shall not contain proprietary information.
Subject terms are keywords that may have been previously assigned to the proposal abstract or are keywords that may be significant to the research. 
 Pages
shall be numbered. The number of pages shall include all pages that have printed data (including the front cover, SF 298, table of contents, and all appendices). Page numbers must match the numbering shown on the Table of Contents. 

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 TABLE OF CONTENTS: Sample table of contents is provided at 

http://mrmc.amedd.army.mil/index.cfm?pageid=researcher_resources.technical_reporting. 

Example Table of Contents 

Page No. 
  

	1.	Introduction 

	2.	Keywords 

	3.	Accomplishments 

	4.	Impact 

	5.	Changes/Problems 

	6.	Products 

	7.	Participants & Other Collaborating Organizations 

	8.	Special Reporting Requirements 

	9.	Appendices 

  

	1.	INTRODUCTION: Narrative that briefly (one paragraph) describes the subject, purpose and scope of the research. 

  

	2.	KEYWORDS: Provide a brief list of keywords (limit to 20 words). 

 3. ACCOMPLISHMENTS: The PI is
reminded that the contract organization is required to obtain prior written approval from the USAMRAA Contract s Officer whenever there are significant changes in the project or its direction. 

 

	 	•	 	What were the major goals and objectives of the project? 

  

	 	•	 	What was accomplished under these goals? 

  

	 	•	 	What opportunities for training and professional development did the project provide? 

  

	 	•	 	How were the results disseminated to communities of interest? 

  

	 	•	 	What do you plan to do during the next reporting period to accomplish the goals and objectives? 

 What were
the major goals of the project? 
 List the major goals of the project as stated in the approved SOW. If the application listed milestones/target dates
for important activities or phases of the project, identify these dates and show actual completion dates or the percentage of completion. 
 Generally, the
goals will not change from one reporting period to the next and are unlikely to change during the final reporting period. However, if the awarding agency approved changes to the goals during the reporting period, list the revised goals and
objectives. Also explain any significant changes in approach or methods from the agency approved application or plan. 
 What was accomplished under
these goals? 
 For this reporting period describe: 1) major activities; 2) specific objectives; 3) significant results or key outcomes, including major
findings, developments, or conclusions (both positive and negative); and/or 4) other achievements. Include a discussion of stated goals not met. Description shall include pertinent data and graphs in sufficient detail to explain any significant
results achieved. A succinct description of the methodology used shall be provided. As the project progresses to completion, the emphasis in reporting in this section should shift from reporting activities to reporting accomplishments. 

What opportunities for training and professional development has the project provided? 

If the project was not intended to provide training and professional development opportunities or there is nothing significant to report during this reporting
period, state “Nothing to Report.” 

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 Describe opportunities for training and professional development provided to anyone who worked on the project
or anyone who was involved in the activities supported by the project. “Training” activities are those in which individuals with advanced professional skills and experience assist others in attaining greater proficiency. Training
activities may include, for example, courses or one-on-one work with a mentor. “Professional development” activities result in increased knowledge or skill in one’s area of expertise and may include workshops, conferences, seminars,
study groups, and individual study. Include participation in conferences, workshops, and seminars not listed under major activities. 
 How were the
results disseminated to communities of interest? 
 If there is nothing significant to report during this reporting period, state “Nothing to
Report.” 
 Describe how the results were disseminated to communities of interest. Include any outreach activities that were undertaken to reach
members of communities who are not usually aware of these project activities, for the purpose of enhancing public understanding and increasing interest in learning and careers in science, technology, and the humanities. 

What do you plan to do during the next reporting period to accomplish the goals? 

If this is the final report, state “Nothing to Report.” 

Describe briefly what you plan to do during the next reporting period to accomplish the goals and objectives. 

4. IMPACT: This component is used to describe ways in which the work, findings, and specific products of the project have had an impact during this
reporting period. Describe distinctive contributions, major accomplishments, innovations, successes, or any change in practice or behavior that has come about as a result of the project relative to: 

 

	 	•	 	the development of the principal discipline(s) of the project; 

  

	 	•	 	other disciplines; 

  

	 	•	 	technology transfer; or 

  

	 	•	 	society beyond science and technology. 

 What was the impact on the development of the principal
discipline(s) of the project? 
 If there is nothing significant to report during this reporting period, state “Nothing to Report.” 

Describe how findings, results, techniques that were developed or extended, or other products from the project made an impact or are likely to make an impact
on the base of knowledge, theory, and research in the principal disciplinary field(s) of the project. Summarize using language that an intelligent lay audience can understand (Scientific American style). 

How the field or discipline is defined is not as important as covering the impact the work has had on knowledge and technique. Make the best distinction
possible, for example, by using a “field” or “discipline,” if appropriate, that corresponds with a single academic department (i.e., physics rather than nuclear physics). 

What was the impact on other disciplines? 
 If there is
nothing significant to report during this reporting period, state “Nothing to Report.” 
 Describe how the findings, results, or techniques that
were developed or improved, or other products from the project made an impact or are likely to make an impact on other disciplines. 

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 What was the impact on technology transfer? 

If there is nothing significant to report during this reporting period, state “Nothing to Report.” 

Describe ways in which the project made an impact, or is likely to make an impact, on commercial technology or public use, including: 

 

	 	•	 	transfer of results to entities in government or industry; 

  

	 	•	 	instances where the research has led to the initiation of a start-up company; or 

  

	 	•	 	adoption of new practices. 

 What was the impact on society beyond science and technology? 

If there is nothing significant to report during this reporting period, state “Nothing to Report.” 

Describe how results from the project made an impact, or are likely to make an impact, beyond the bounds of science, engineering, and the academic world on
areas such as: 
  

	 	•	 	improving public knowledge, attitudes, skills, and abilities; 

  

	 	•	 	changing behavior, practices, decision making, policies (including regulatory policies), or social actions; or 

  

	 	•	 	improving social, economic, civic, or environmental conditions. 

 5. CHANGES/PROBLEMS: The Project
Director/Principal Investigator (PD/PI) is reminded that the contract organization is required to obtain prior written approval from the awarding agency Contracts Officer whenever there are significant changes in the project or its direction. If not
previously reported in writing, provide the following additional information or state, “Nothing to Report,” if applicable: 
  

	 	•	 	Changes in approach and reasons for change. 

  

	 	•	 	Actual or anticipated problems or delays and actions or plans to resolve them. 

  

	 	•	 	Changes that have a significant impact on expenditures. 

  

	 	•	 	Significant changes in use or care of human subjects, vertebrate animals, biohazards, and/or select agents. 

Changes in approach and reasons for change 
 Describe any
changes in approach during the reporting period and reasons for these changes. Remember that significant changes in objectives and scope require prior approval of the agency. 

Actual or anticipated problems or delays and actions or plans to resolve them 

Describe problems or delays encountered during the reporting period and actions or plans to resolve them. 

Changes that had a significant impact on expenditures 

Describe changes during the reporting period that may have had a significant impact on expenditures, for example, delays in hiring staff or favorable
developments that enable meeting objectives at less cost than anticipated. 
 Significant changes in use or care of human subjects, vertebrate animals,
biohazards, and/or select agents 
 Describe significant deviations, unexpected outcomes, or changes in approved protocols for the use or care of human
subjects, vertebrate animals, biohazards, and/or select agents during the reporting period. If required, were these changes approved by the applicable institution committee (or equivalent) and reported to the agency? Also specify the applicable
Institutional Review Board/Institutional Animal Care and Use Committee approval dates. 
 6. PRODUCTS: List any products resulting from the project
during the reporting period. Examples of products include: 
  

	 	•	 	publications, conference papers, and presentations; 

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	 	•	 	website(s) or other Internet site(s); 

  

	 	•	 	technologies or techniques; 

  

	 	•	 	inventions, patent applications, and/or licenses; and 

  

	 	•	 	other products. 

 If there is nothing to report under a particular item, state “Nothing to Report.”

  

	 	•	 	Publications, conference papers, and presentations 

 Report only the major publication(s) resulting from
the work under this award. There is no restriction on the number. However, agencies are interested in only those publications that most reflect the work under this award in the following categories: 

Journal publications. List peer-reviewed articles or papers appearing in scientific, technical, or professional journals. Include any
peer-reviewed publication in the periodically published proceedings of a scientific society, a conference, or the like. A publication in the proceedings of a one-time conference, not part of a series, should be reported under “Books or other
non-periodical, one-time publications.” 
 Identify for each publication: Author(s); title; journal; volume: year; page numbers; status
of publication (published; accepted, awaiting publication; submitted, under review; other); acknowledgement of federal support (yes/no). 

Books or other non-periodical, one-time publications. Report any book, monograph, dissertation, abstract, or the like published as or in
a separate publication, rather than a periodical or series. Include any significant publication in the proceedings of a one-time conference or in the report of a one-time study, commission, or the like. 

Identify for each one-time publication: Author(s); title; editor; title of collection, if applicable; bibliographic information; year; type of
publication (e.g., book, thesis or dissertation); status of publication (published; accepted, awaiting publication; submitted, under review; other); acknowledgement of federal support (yes/no). 

Other publications, conference papers, and presentations. Identify any other publications, conference papers and/or presentations not
reported above. Specify the status of the publication as noted above. List presentations made during the last year (international, national, local societies, military meetings, etc.). Use an asterisk (*) if presentation produced a manuscript.

  

	 	•	 	Website(s) or other Internet site(s) 

 List the URL for any Internet site(s) that disseminates the
results of the research activities. A short description of each site should be provided. It is not necessary to include the publications already specified above in this section. 

 

	 	•	 	Technologies or techniques 

 Identify technologies or techniques that resulted from the research
activities. In addition to a description of the technologies or techniques, describe how they will be shared. 
  

	 	•	 	Inventions, patent applications, and/or licenses 

 Identify inventions, patent applications with date,
and/or licenses that have resulted from the research. State whether an application is provisional or non-provisional and indicate the application number. Submission of this information as part of an interim research performance progress report is
not a substitute for any other invention reporting required under the terms and conditions of an award. 

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	 	•	 	Other Products 

 Identify any other reportable outcomes that were developed under this project.
Reportable outcomes are defined as a research result that is or relates to a product, scientific advance, or research tool that makes a meaningful contribution toward the understanding, prevention, diagnosis, prognosis, treatment, and/or
rehabilitation of a disease, injury or condition, or to improve the quality of life. Examples include: 
  

	 	•	 	data or databases; 

  

	 	•	 	biospecimen collections; 

  

	 	•	 	audio or video products; 

  

	 	•	 	software; 

  

	 	•	 	models; 

  

	 	•	 	educational aids or curricula; 

  

	 	•	 	instruments or equipment; 

  

	 	•	 	research material (e.g., Germplasm; cell lines, DNA probes, animal models); 

  

	 	•	 	clinical interventions; 

  

	 	•	 	new business creation; and 

  

	 	•	 	other. 

 7. PARTICIPANTS & OTHER COLLABORATING ORGANIZATIONS 

Provide the following information on participants: 
  

	 	•	 	what individuals have worked on the project? 

  

	 	•	 	has there been a change in the other active support of the PD/PI(s) or senior/key personnel since the last reporting period? 

  

	 	•	 	what other organizations have been involved as partners? 

 What individuals have worked on the project?

 Provide the following information for: (1) PDs/PIs; and (2) each person who has worked at least one person month per year on the project
during the reporting period, regardless of the source of compensation (a person month equals approximately 160 hours of effort). 
  

	 	•	 	Provide the name and identify the role the person played in the project. Indicate the nearest whole person month (Calendar, Academic, Summer) that the individual worked on the project. Show the most senior role
in which the person worked on the project for any significant length of time. For example, if an undergraduate student graduated, entered graduate school, and continued to work on the project, show that person as a graduate student, preferably
explaining the change in involvement. 

 Describe how this person contributed to the project and with what funding
support. If information is unchanged from a previous submission, provide the name only and indicate “no change”. 
  

			
	            Example:	  	
	            Name:	  	Mary Smith
	            Project Role:	  	Graduate Student
	            Researcher Identifier (e.g., ORCID ID):	  	1234567
	            Nearest person month worked:	  	5
	            Contribution to Project:	  	Ms. Smith has performed work in the area of
		  	combined error-control and constrained coding
	            Funding Support:	  	The XYZ Foundation (Complete only if the
		  	funding support is provided from other than this award.)

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 Has there been a change in the active other support of the PD/PI(s) or senior/key personnel since the last
reporting period? 
 If there is nothing significant to report during this reporting period, state “Nothing to Report.” 

If the active support has changed for the PD/PI(s) or senior/key personnel, then describe what the change has been. Changes may occur, for example, if a
previously active contract has closed and/or if a previously pending contract is now active. Annotate this information so it is clear what has changed from the previous submission. 

Submission of other support information is not necessary for pending changes or for changes in the level of effort for active support reported previously. The
awarding agency may require prior written approval if a change in active other support significantly impacts the effort on the project that is the subject of the project report. 

What other organizations were involved as partners? 
 If
there is nothing significant to report during this reporting period, state “Nothing to Report.” 
 Describe partner organizations – academic
institutions, other nonprofits, industrial or commercial firms, state or local governments, schools or school systems, or other organizations (foreign or domestic) – that were involved with the project. Partner organizations may have provided
financial or in-kind support, supplied facilities or equipment, collaborated in the research, exchanged personnel, or otherwise contributed. 
 Provide the
following information for each partnership: 
 Organization Name: 

Location of Organization: (if foreign location list country) 

Partner’s contribution to the project (identify one or more) 
  

	 	•	 	Financial support; 

  

	 	•	 	In-kind support (e.g., partner makes software, computers, equipment, etc., available to project staff); 

  

	 	•	 	Facilities (e.g., project staff use the partner’s facilities for project activities); 

  

	 	•	 	Collaboration (e.g., partner’s staff work with project staff on the project); 

  

	 	•	 	Personnel exchanges (e.g., project staff and/or partner’s staff use each other’s facilities, work at each other’s site); and 

 

	 	•	 	Other. 

 8. SPECIAL REPORTING REQUIREMENTS: 

QUAD CHARTS: The Quad Chart (available on https://www.usamraa.army.mil) shall be updated and submitted as an appendix. 

9. APPENDICES: Attach all appendices that contain information that supplements, clarifies or supports the text. Examples include original copies of
journal articles, reprints of manuscripts and abstracts, a curriculum vitae, patent applications, study questionnaires, and surveys, etc. 
 DELIVERABLE
9: DOD REVIEW MEETING 
 In addition to technical progress reports, the PI shall prepare for and participate in at least one DOD Review Meeting such as
an Interim Progress Review (IPR) for each year of the project’s term of award. Generally, the IPR will last no longer than two days and require no more than two overnight stays. It most likely will be held at Fort Detrick. 

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 DELIVERY INFORMATION 
  

									
	CLIN	  	DELIVERY DATE	  	QUANTITY	  	SHIP TO ADDRESS	  	DODAAC
	0001	  	 POP 01-SEP-2015 TO
 30-NOV-2017
	  	N/A	  	 FORT DETRICK - CDMRP
 FORT DETRICK - CDMRP

1120 FORT DETRICK
 FREDERICK MD 21702

FOB: Destination
  
	  	W91ZSQ
	0002	  	 POP 01-SEP-2015 TO
 30-NOV-2017
	  	N/A	  	 (SAME AS PREVIOUS LOCATION)
 FOB:
Destination
	  	W91ZSQ

 CLAUSES INCORPORATED BY FULL TEXT 

252.235-7011 FINAL SCIENTIFIC OR TECHNICAL REPORT (JAN 2015) 

The Contractor shall— 
 (a) Submit an electronic copy of the
approved final scientific or technical report, not a summary, delivered under this contract to the Defense Technical Information Center (DTIC) through the web-based input system at http://www.dtic.mil/dtic/submit/ as required by DoD
Instruction 3200.12, DoD Scientific and Technical Information Program (STIP). Include a completed Standard Form (SF) 298, Report Documentation Page, in the document, or complete the web-based SF 298. 

(b) For instructions on submitting multi-media reports, follow the instructions at http://www.dtic.mil/dtic/submit. 

(c) Email classified reports (up to Secret) to TR@DTIC.SMIL.MIL. If a SIPRNET email capability is not available, follow the classified submission
instructions at http://www.dtic.mil/dtic/submit/. 
 (End of clause) 

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 Section G - Contract Administration Data 

CPARS 
 Contractor Performance Assessment Reporting
System (CPARS) (USAMRAA) (May 2015) 
 A CPAR assesses a contractor’s performance and provides a record, both positive and negative, on a given
contractor during a specific period of time. Each assessment is based on objective facts and supported by program and contract management data, such as cost performance reports, customer comments, quality reviews, technical interchange meetings,
financial solvency assessments, construction/production management reviews, contractor operations reviews, functional performance evaluations, and earned contract incentives. Performance evaluations are transmitted into the Past Performance
Information Retrieval System (PPIRS) which is used by government agencies to assess contractor past performance for future acquisitions. The contractor shall appoint a Contractor Representative (CR) and provide this information to the Contracting
Officer (KO) within 10 calendar days of award. The contractor POC shall have the authority to comment on the CPAR assessment on behalf of their company and within the timeframes established. 

A CPARS assessment must be completed within 120 calendar days after the evaluation. Evaluations are sent to PPIRS within 14 calendar days after the government
Assessing Official (AO) has submitted the rating. If the CR has not concurred/non-concurred with the rating; PPIRS will show the government evaluation as “Contractor Comment Pending Review”. The CR has a total of 60 calendar days to
concur/non-concur with the assessment. After 60 days is the contractor, the CR can either concur/non-concur The CR has the authority to: access the Government evaluation; review/comment/concur or non-concur with the assessment. The CR has 60
calendar days after notification of the government’s assessment to review/comment/concur or non-concur. The CR has the right to schedule a meeting (in writing) with the government within 7 calendar days of notification of an assessment. Once
the government and the CR complete the evaluation; an automatic update will be sent to PPIRS and visible for Source Selection. If the CR fails to respond within 60 days, the assessment will be finalized. Training for CPARS can be found on the CPARS
website: https://www.cpars.gov/index.htm. 
 To access CPARS, the contractor must have a Public Key Infrastructure (PKI). It is suggested an ECA
certificate of Medium Assurance should be purchased. This should be a Department of Defense identity certificate, not an e-mail certificate. 
 PAYMENT
INFORMATION 
 INVOICING INSTRUCTIONS 

INVOICES SHALL be entered into Wide Area Work Flow (WAWF) website at https://wawf.eb.mil/. For “training” instructions on using WAWF
click on “About WAWF”, then click on “Training.” Please reference the “Electronic Submission of Payment Requests and Receiving Reports (June 2012)” for specific invoicing instructions in WAWF. 

 

	 	•	 	Contractor invoices shall be prepared and submitted according to DFARS 252.232-7003, entitled “Electronic Submission of Payment Request.” (see Section “G” of this contract) 

 

	 	•	 	Each voucher submitted must state the period of performance (POP) of the contract. (i.e. 15 May 2015 – 14 May 2020) 

  

	 	•	 	Each voucher should be submitted monthly and must request payment for amount stated in the appropriate Contract Line Item (CLIN). (i.e. CLIN 0001) 

 

	 	•	 	Contractor shall request payment in the format of the Contract Line Item (CLIN). In accordance with FAR 52.232-12 Advance Payments are not allowable. Payments will only be made for the amount of work completed.

 RECEIVING REPORTS shall be entered into Wide Area Work Flow (WAWF) website at https://wawf.eb.mil/. For specific instructions
on using WAWF, click on “About WAWF”, and then click on “Training.” 

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 PAYMENT PROCESSING: 

Defense Finance and Accounting Service (DFAS) is responsible for payment once invoice(s) and receiving report(s) have been entered into Wide Area Work Flow
(WAWF) website. 
 RATES 
 CBLI currently does not have
a DCAA forward pricing rate agreement, therefore Fringe, Overhead, and G&A will be capped at the rate requested in the budget and outlined below: 

Fringe: 33.8% 
 Overhead: 22.75% 

G&A: 2% 
 If DCAA issues a Forward Pricing Rate Agreement for
CBLI that covers the timeframe of this period of performance, the rates will be adjusted downward in accordance with the approved Forward Pricing Rate Agreement if applicable. If not the rates will be capped as outlined above. 

ACCOUNTING SYSTEM 
 CBLI has not had a DCAA accounting
system review to determine adequacy. A pre-award accounting system survey was requested from DCAA and is pending. A full post award accounting system audit will be requested if the results of the pre-award survey finds any significant issues with
CBLI’s accounting systems. At that time, the Contracting Officer will review DCAA’s recommendations and the contract may be modified accordingly. 

ACCOUNTING AND APPROPRIATION DATA 
  

									
	 AA: 09720142015013000018310443439410
	  	 	R.0012069.1.1	  	  	 	6100.9000021001	  
	 COST CODE: A7444
	  				  			
	 AMOUNT: $5,506,165.00
	  				  			
	 CIN GFEBS001062427800003: $5,506,165.00
	  				  			
			
	 AB: 09720142015013000018310444441410
	  	 	R.0012070.1	  	  	 	6100.9000021001	  
	 COST CODE: A7444
	  				  			
	 AMOUNT: $3,720,289.64
	  				  			
	 CIN GFEBS001062427800004: $3,720,289.64
	  				  			

 CLAUSES INCORPORATED BY FULL TEXT 

252.232-7003       ELECTRONIC SUBMISSION OF PAYMENT REQUESTS AND RECEIVING REPORTS 

(JUNE 2012) 
 (a) Definitions. As used in this clause– 

(1) Contract financing payment and invoice payment have the meanings given in section 32.001 of the Federal Acquisition Regulation. 

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 (2) Electronic form means any automated system that transmits information electronically from the initiating
system to all affected systems. Facsimile, e-mail, and scanned documents are not acceptable electronic forms for submission of payment requests. However, scanned documents are acceptable when they are part of a submission of a payment request made
using Wide Area WorkFlow (WAWF) or another electronic form authorized by the Contracting Officer. 
 (3) Payment request means any request for contract
financing payment or invoice payment submitted by the Contractor under this contract. 
 (4) Receiving report means the data required by the clause at
252.246-7000, Material Inspection and Receiving Report. 
 (b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment
requests and receiving reports using WAWF, in one of the following electronic formats that WAWF accepts: Electronic Data Interchange, Secure File Transfer Protocol, or World Wide Web input. Information regarding WAWF is available on the Internet at
https://wawf.eb.mil/. 
 (c) The Contractor may submit a payment request and receiving report using other than WAWF only when– 

(1) The Contracting Officer administering the contract for payment has determined, in writing, that electronic submission would be unduly burdensome to the
Contractor. In such cases, the Contractor shall include a copy of the Contracting Officer’s determination with each request for payment; 
 (2) DoD
makes payment for commercial transportation services provided under a Government rate tender or a contract for transportation services using a DoD-approved electronic third party payment system or other exempted vendor payment/invoicing system
(e.g., PowerTrack, Transportation Financial Management System, and Cargo and Billing System); 
 (3) DoD makes payment for rendered health care services
using the TRICARE Encounter Data System (TEDS) as the electronic format; or 
 (4) When the Governmentwide commercial purchase card is used as the method of
payment, only submission of the receiving report in electronic form is required. 
 (d) The Contractor shall submit any non-electronic payment requests using
the method or methods specified in Section G of the contract. 
 (e) In addition to the requirements of this clause, the Contractor shall meet the
requirements of the appropriate payment clauses in this contract when submitting payments requests. 
 (End of clause) 

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013) 

(a) Definitions. As used in this clause— 
 Department of
Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies a unit, activity, or organization. 
 Document type means the type of
payment request or receiving report available for creation in Wide Area WorkFlow (WAWF). 

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 Local processing office (LPO) is the office responsible for payment certification when payment certification
is done external to the entitlement system. 
 (b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests and
receiving reports, as authorized by DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports. 
 (c) WAWF access. To access WAWF,
the Contractor shall— 
 (1) Have a designated electronic business point of contact in the System for Award Management at https://www.acquisition.gov;
and 
 (2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this Web site. 

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before
submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/. 

(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data Interchange, or File Transfer Protocol. 

(f) WAWF payment instructions. The Contractor must use the following information when submitting payment requests and receiving reports in WAWF for this
contract/order: 
 (1) Document type. The Contractor shall use the following document type(s). 

_Cost Voucher             

(2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in WAWF, as specified by the contracting
officer. 
 W91ZSQ 
 (3) Document routing. The Contractor shall
use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system. 

Routing Data Table* 
  

			
	 Field Name in WAWF
	  	 Data to be entered in WAWF

	Pay Official DoDAAC	  	HQ0490
	Issue By DoDAAC	  	W81XWH
	Admin DoDAAC	  	W81XWH
	Inspect By DoDAAC	  	W91ZSQ
	Ship To Code	  	W91ZSQ
	Ship From Code	  	N/A
	Mark For Code	  	N/A
	Service Approver (DoDAAC)	  	W91ZSQ
	Service Acceptor (DoDAAC)	  	W91ZSQ
	Accept at Other DoDAAC	  	N/A
	LPO DoDAAC	  	N/A
	DCAA Auditor DoDAAC	  	HAA653
	Other DoDAAC(s)	  	N/A

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 (4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes
appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g. timesheets) in
support of each payment request. 
 (5) WAWF email notifications. The Contractor shall enter the email address identified below in the “Send Additional
Email Notifications” field of WAWF once a document is submitted in the system. 
 eva.lai.civ@mail.mil 

(g) WAWF point of contact. (1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity’s WAWF
point of contact. 
 jesse.m.hoffman2.civ@mail.mil 
  

	(2)	For technical WAWF help, contact the WAWF helpdesk at 866-618-5988. 

 (End of clause) 

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 Section H - Special Contract Requirements 

SPECIAL CONTRACT REQUIREMENTS 
 Travel 

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. Contractor shall submit
travel requests with estimated costs to the COR NLT 15 days prior to travel. Travel costs shall be incurred and billed in accordance with FAR Part 31. Costs for these expenses will be reviewed, certified and approved by the COR. All travel and
transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area results in reasonable charges to the government. The Government will not pay for business class or first-class travel.
Lodging and meals shall be reimbursed in accordance with regulations defined in FAR PART 31. Funding for travel will be provided as indicated in the final project budget. 

DOD Contractor Foreign Travel (USAMRAA) (May 2015) 

Approval of Foreign Travel. Foreign travel under this contract is defined as any travel outside of the continental United States and its territories and
possessions. The cost of foreign travel is allowable only when specific written approval of the Contracting Officer is obtained prior to the commencement of the travel. This is a requirement for all DoD contractors traveling on official DoD business
in conjunction with DoD travel. 
 1. The following requirements will be accomplished by the contractor(s) prior to foreign travel on approval of the
Contracting Officer. Allow 90 days for completion of training requirements and approval of the application process. Detailed information can be found on the MRMC website: https://mrmc.amedd.army.mil/index.cfm?pageid=mrmc_resources.oconus. Select all
the links under “Contractor Travel Requirements” and comply with the instructions. Consult the DoD Foreign Clearance Guide https://www.fcg.pentagon.mil 

2. Mandatory training and minimum requirements must be met and a copy provided to the contracting officer 15 days prior to scheduled departure. 

3. Costs incurred by contractor personnel on official contract business, whether foreign travel and/or domestic/local travel, are allowable subject to the
limitations in the Federal Acquisition Regulation (FAR clause 52.216-7 Allowable Cost and Payment); incorporated into this contract. 
 4. MANDATORY TRAINING
– OFFICIAL GOVERNMENT TRAVEL 
 (a) Anti-Terrorism Level 1 (valid for one year) 

(b) SERE 100 (valid for two years) 
 (c) PRO-File 

(d) Human Rights, SOUTHCOM travel only (valid for one year) 
 (e)
US Forces Korea, Korea travel only (valid for one year) 
 4.1. MINIMUM MANDATORY DOCUMENTATION 

(a) USAMRMC Form 55-46 (Request for OCONUS Travel) 
 (b) Flight
Itinerary 
 (c) LOA’s generated through the Synchronized Pre-deployment and Operational Tracker (SPOT); completed by the responsible Contracting
Officer 
 (d) Force Protection Plan signed by the traveler and Commanding Officer. 

(e) If traveling to a Restricted or FPCON Charlie and Delta areas, the Force Protection Plan must also be signed by a GO/FO or DoD equivalent 

(f) Area of responsibility briefing completed within three months of travel 

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 (g) PACOM travel; verification that PACOM’s Travel Tracker/Individual Antiterrorism Plan (TT/IATP) has
been completed 
 (h) AFRICOM travel; verification that AFRICOM’S Theater Information Management System (TIMS) or Statement of Preparedness Document
(when TIMS is not available), has been completed. 
 (i) USFK Form 700-19A-R-E 

(j) US-ROK SOFA IAW FAR 25.8 and USFK Regulation 700-19. 
 5.
TRAINING LINKS 
 (a) Anti-Terrorism Level 1- https://atlevel1.dtic.mil/at/. 

(b) SERE 100 - https://jko.ifcom.mil 
 (c) PRO-File -
https://prmsglobal.prms.af.mil/prmsconv/profile/survey/survey.aspx 
 (d) Human Rights - https://www.americasnet.org. 

(e) US Forces Korea - https://www.usfk.mil 

PROHIBITION OF USE OF LABORATORY ANIMALS (June 2015) (USAMRAA) 

PROHIBITION – READ FURTHER FOR DETAILS 

Notwithstanding any other terms and conditions contained in this award or incorporated by reference herein, the contractor is expressly forbidden to use or
subcontract for the use of laboratory animals in any manner whatsoever without the express written approval of the USAMRMC, Animal Care and Use Review Office (ACURO). Written authorization to begin research under the applicable protocol(s) proposed
for this award will be issued in the form of an approval letter from the USAMRMC ACURO to the contractor with a copy to the USAMRAA Contracting Office. Furthermore, modifications to already approved extramural protocols require approval by ACURO
prior to implementation. Once approved, notification must be given immediately to USAMRAA contracting. For each fiscal year, the contractor shall maintain, and upon request from ACURO, submit animal usage information. Non-compliance with any of
these terms and conditions may result in withholding of funds and/or the terminations of the award. 
 PROHIBITION OF HUMAN RESEARCH, USE
OF HUMAN SUBJECTS (June 2015) (USAMRAA) 
 PROHIBITION – READ FURTHER FOR DETAILS 

a. The contractor or its subcontractors, are authorized to conduct research under this award involving humans as research subjects for the following
protocols: Protocols not identified are not approved. 
 Research under this award involving the use of human subjects, to include the use of human
anatomical substances or identifiable private information (human data), shall not begin until the USAMRMC’s Office of Research Protections (ORP) provides authorization that the research may proceed. Written approval to begin research will be
issued from the USAMRMC ORP, under separate notification to the contractor. Written approval from the USAMRMC ORP is also required for any subcontractor that will use funds from this award to conduct research involving human subjects. 

Research involving human subjects shall be conducted in accordance with the protocol submitted to and approved by the USAMRMC ORP. Complete study records
shall be maintained for each human research study and shall be made available for review by representatives of the USAMRMC. Research records shall be stored in a confidential manner so as to protect the confidentiality of subject information. 

The contractor is required to adhere to the following reporting requirements: 

Submission of major modifications to the protocol, continuing review documentation, and the final report are required as outlined in the USAMRMC ORP approval
memorandum. 

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 Unanticipated problems involving risks to subjects or others, clinical holds (voluntary or involuntary), and
suspension or termination of this research by the IRB, the institution, the Sponsor, or regulatory agencies, shall be promptly reported to the USAMRMC ORP and the USAMRAA Contracting Office. 

The knowledge of any pending compliance inspection/visits by the FDA, ORP, or other government agency concerning this clinical investigation or research, the
issuance of Inspection Reports, FDA Form 483, warning letters or actions taken by any Regulatory Agencies including legal or medical actions, and any instances of serious or continuing non-compliance with regulatory requirements that relate to this
clinical investigation or research, shall be reported immediately to the USAMRMC ORP and the USAMRAA Contracting Office. Non-compliance with these terms and conditions may result in withholding of funds and/or the termination of the award. 

PROHIBITION OF USE OF HUMAN CADAVERS (June 2015) (USAMRAA) 

PROHIBITION – READ FURTHER FOR DETAILS 

Research, development, testing and evaluation (RDT&E), education or training activities involving human cadaveric specimens under this award shall not
begin until approval is granted in accordance with the Army Policy for Use of Human Cadavers for RDT&E, Education, or Training, 20 April 2012 (https://mrmc.amedd.army.mil/index.cfm?pageid=research_ protections.overview). The USAMRMC Office
of Research Protections (ORP) is the Action Office (usarmy.detrick.medcom-usamrmc.other.hrpo@mail.mil ) for this policy. Approval must be obtained from the Head of the Army organization that is supporting/funding the activity involving cadavers as
described in the Army Policy for Use of Human Cadavers. For certain activities involving cadavers, including activities supported/funded by the USAMRMC, approval must also be obtained from ORP. Award contractors must coordinate with the
supporting/funding Army organization to ensure that proper approvals are obtained. Written approvals to begin the activity will be issued under separate notification to the contractor. Non-compliance with these terms and conditions may result in
withholding of funds and/or the termination of the award. are obtained. Written approvals to begin the activity will be issued under separate notification to the contractor. Non-compliance with these terms. 

USE OF TECHNICAL REFERENCE FACILITY (June 2015) (USAMRAA) 

The contractor agrees to use, to the extent practical, the technical reference facilities of the Defense Technical Information Center (DTIC) for the purpose
of surveying existing knowledge and avoiding needless duplication of scientific and engineering effort and the expenditure thereby represented. The DTIC headquarters office is located at 8725 John J. Kingman Road, Fort Belvoir, VA 22060-6218.
Information can also be obtained via the Internet at http://www.dtic.mil or via the toll-free number for the DTIC help desk, 1-800-225-3842. To the extent practical, all other sources, whether or not Government controlled, should be consulted for
the same purpose. 
 INVESTIGATING AND REPORTING POSSIBLE SCIENTIFIC MISCONDUCT (June 2015) (USAMRAA) 

a. “Misconduct” or “Misconduct in Science” is defined as fabrication, falsification, plagiarism, or other practices that seriously deviate
from those that are commonly accepted within the scientific community for proposing, conducting or reporting research. It does not include honest error or honest differences in interpretations or judgments of data. 

b. Contractors shall foster a research environment that prevents misconduct in all research and that deals forthrightly with possible misconduct associated
with research for which U.S. Army Medical Research and Materiel Command funds have been provided or requested. 
 c. The contractor agrees to: 

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 (1) Establish and keep current an administrative process to review, investigate, and report allegations of
misconduct in science in connection with research conducted by the contractor; 
 (2) Comply with its own administrative process; 

(3) Inform its scientific and administrative staff of the policies and procedures and the importance of compliance with those policies and procedures; 

(4) Take immediate and appropriate action as soon as misconduct on the part of employees or persons within the organization’s control is suspected or
alleged; and 
 (5) Report to the Administrative Contracting Officer (ACO) a decision to initiate an investigation into possible scientific misconduct. 

d. The contractor is responsible for notifying the ACO of appropriate action taken if at any stage of an inquiry or investigation any of the following
conditions exist: 
 (1) An immediate health hazard is involved; 

(2) There is an immediate need to protect Federal funds or equipment; 

(3) A probability exists that the alleged incident will be reported publicly; or 

(4) There is a reasonable indication of possible criminal violation. 

CLAUSES INCORPORATED BY FULL TEXT 
 PRINCIPAL INVESTIGATOR
(DEC 2006) (USAMRAA) 
 The Principal Investigator for this contract is Dr. Andrei Gudkov. This individual shall be continuously responsible for the
conduct of the research project. The contractor shall obtain the Contracting Officer’s approval to change the Principal Investigator or to continue the research work during a continuous period in excess of three months without the participation
of an approved Principal Investigator. This contract is based on the Principal Investigator devoting 6.2 Calendar Months of effort to the project over the term of the contract. The contractor shall advise the Contracting Officer if the Principal
Investigator will, or plans to, revise the level of effort estimated in the contractor’s proposal. A curriculum vitae shall be provided for professional associates added to the research project or substituted during the course of work. 

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 Section I - Contract Clauses 

CLAUSES INCORPORATED BY REFERENCE 
  

					
	52.202-1	  	Definitions	  	NOV 2013
	52.203-3	  	Gratuities	  	APR 1984
	52.203-5	  	Covenant Against Contingent Fees	  	MAY 2014
	52.203-6	  	Restrictions On Subcontractor Sales To The Government	  	SEP 2006
	52.203-7	  	Anti-Kickback Procedures	  	MAY 2014
	52.203-8	  	Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity	  	MAY 2014
	52.203-10	  	Price Or Fee Adjustment For Illegal Or Improper Activity	  	MAY 2014
	52.203-12	  	Limitation On Payments To Influence Certain Federal Transactions	  	OCT 2010
	52.204-4	  	Printed or Copied Double-Sided on Postconsumer Fiber Content Paper	  	MAY 2011
	52.204-7	  	System for Award Management	  	JUL 2013
	52.204-10	  	Reporting Executive Compensation and First-Tier Subcontract Awards	  	JUL 2013
	52.204-19	  	Incorporation by Reference of Representations and Certifications.	  	DEC 2014
	52.209-5	  	Certification Regarding Responsibility Matters	  	APR 2010
	52.209-6	  	Protecting the Government’s Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment	  	AUG 2013
	52.209-7	  	Information Regarding Responsibility Matters	  	JUL 2013
	52.209-9	  	Updates of Publicly Available Information Regarding Responsibility Matters	  	JUL 2013
	52.215-2	  	Audit and Records—Negotiation	  	OCT 2010
	52.215-8	  	Order of Precedence—Uniform Contract Format	  	OCT 1997
	52.215-12	  	Subcontractor Certified Cost or Pricing Data	  	OCT 2010
	52.215-14	  	Integrity of Unit Prices	  	OCT 2010
	52.215-15	  	Pension Adjustments and Asset Reversions	  	OCT 2010
	52.215-23	  	Limitations on Pass-Through Charges	  	OCT 2009
	52.216-7	  	Allowable Cost And Payment	  	JUN 2013
	52.219-8	  	Utilization of Small Business Concerns	  	OCT 2014
	52.219-28	  	Post-Award Small Business Program Rerepresentation	  	JUL 2013
	52.222-1	  	Notice To The Government Of Labor Disputes	  	FEB 1997
	52.222-3	  	Convict Labor	  	JUN 2003
	52.222-4	  	Contract Work Hours and Safety Standards- Overtime Compensation	  	MAY 2014
	52.222-21	  	Prohibition Of Segregated Facilities	  	APR 2015
	52.222-40	  	Notification of Employee Rights Under the National Labor Relations Act	  	DEC 2010
	52.222-50	  	Combating Trafficking in Persons	  	MAR 2015
	52.222-54	  	Employment Eligibility Verification	  	AUG 2013
	52.223-6	  	Drug-Free Workplace	  	MAY 2001
	52.223-18	  	Encouraging Contractor Policies To Ban Text Messaging While Driving	  	AUG 2011
	52.224-1	  	Privacy Act Notification	  	APR 1984
	52.224-2	  	Privacy Act	  	APR 1984
	52.225-13	  	Restrictions on Certain Foreign Purchases	  	JUN 2008
	52.227-1	  	Authorization and Consent	  	DEC 2007
	52.227-11	  	Patent Rights—Ownership By The Contractor	  	MAY 2014

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	52.228-7	  	Insurance—Liability To Third Persons	  	MAR 1996
	52.229-3	  	Federal, State And Local Taxes	  	FEB 2013
	52.232-1	  	Payments	  	APR 1984
	52.232-8	  	Discounts For Prompt Payment	  	FEB 2002
	52.232-9	  	Limitation On Withholding Of Payments	  	APR 1984
	52.232-17	  	Interest	  	MAY 2014
	52.232-20	  	Limitation Of Cost	  	APR 1984
	52.232-23	  	Assignment Of Claims	  	MAY 2014
	52.232-25	  	Prompt Payment	  	JUL 2013
	52.232-33	  	Payment by Electronic Funds Transfer—System for Award Management	  	JUL 2013
	52.233-1	  	Disputes	  	MAY 2014
	52.233-3	  	Protest After Award	  	AUG 1996
	52.242-4	  	Certification of Final Indirect Costs	  	JAN 1997
	52.242-13	  	Bankruptcy	  	JUL 1995
	52.242-15	  	Stop-Work Order	  	AUG 1989
	52.243-2	  	Changes—Cost-Reimbursement	  	AUG 1987
	52.243-6	  	Change Order Accounting	  	APR 1984
	52.244-2	  	Subcontracts	  	OCT 2010
	52.245-1	  	Government Property	  	APR 2012
	52.245-9	  	Use And Charges	  	APR 2012
	52.246-9	  	Inspection Of Research And Development (Short Form)	  	APR 1984
	52.246-15	  	Certificate of Conformance	  	APR 1984
	52.246-16	  	Responsibility For Supplies	  	APR 1984
	52.246-23	  	Limitation Of Liability	  	FEB 1997
	52.246-25	  	Limitation Of Liability—Services	  	FEB 1997
	52.247-63	  	Preference For U.S. Flag Air Carriers	  	JUN 2003
	52.249-4	  	Termination For Convenience Of The Government (Services) (Short Form)	  	APR 1984
	52.249-6	  	Termination (Cost Reimbursement)	  	MAY 2004
	52.249-14	  	Excusable Delays	  	APR 1984
	52.252-6	  	Authorized Deviations In Clauses	  	APR 1984
	52.253-1	  	Computer Generated Forms	  	JAN 1991
	252.203-7000	  	Requirements Relating to Compensation of Former DoD Officials	  	SEP 2011
	252.203-7001	  	Prohibition On Persons Convicted of Fraud or Other Defense-Contract-Related Felonies	  	DEC 2008
	252.203-7002	  	Requirement to Inform Employees of Whistleblower Rights	  	SEP 2013
	252.204-7003	  	Control Of Government Personnel Work Product	  	APR 1992
	252.204-7012	  	Safeguarding of Unclassified Controlled Technical Information	  	NOV 2013
	252.211-7007	  	Reporting of Government-Furnished Property	  	AUG 2012
	252.215-7002	  	Cost Estimating System Requirements	  	DEC 2012
	252.225-7012	  	Preference For Certain Domestic Commodities	  	FEB 2013
	252.225-7031	  	Secondary Arab Boycott Of Israel	  	JUN 2005
	252.227-7013	  	Rights in Technical Data—Noncommercial Items	  	FEB 2014
	252.227-7016	  	Rights in Bid or Proposal Information	  	JAN 2011
	252.227-7017	  	Identification and Assertion of Use, Release, or Disclosure Restrictions	  	JAN 2011
	252.227-7030	  	Technical Data—Withholding Of Payment	  	MAR 2000
	252.227-7037	  	Validation of Restrictive Markings on Technical Data	  	JUN 2013
	252.227-7039	  	Patents—Reporting Of Subject Inventions	  	APR 1990
	252.231-7000	  	Supplemental Cost Principles	  	DEC 1991
	252.232-7007	  	Limitation Of Government’s Obligation	  	APR 2014
	252.235-7010	  	Acknowledgment of Support and Disclaimer	  	MAY 1995

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	252.243-7001	  	Pricing Of Contract Modifications	  	DEC 1991
	252.243-7002	  	Requests for Equitable Adjustment	  	DEC 2012
	252.245-7001	  	Tagging, Labeling, and Marking of Government-Furnished Property	  	APR 2012
	252.245-7002	  	Reporting Loss of Government Property	  	APR 2012
	252.245-7003	  	Contractor Property Management System Administration	  	APR 2012
	252.245-7004	  	Reporting, Reutilization, and Disposal	  	MAR 2015
	252.246-7003	  	Notification of Potential Safety Issues	  	JUN 2013

 CLAUSES INCORPORATED BY FULL TEXT 

52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) 
 The Government
may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option
provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 Days. 

(End of clause) 
 52.252-2 CLAUSES INCORPORATED BY REFERENCE
(FEB 1998) 
 This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request,
the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): 

http://farsite.hill.af.mil/ 
 (End of clause) 

 W81XWH-15-C-0101 

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 Section J - List of Documents, Exhibits and Other Attachments 

ATTACHMENTS 
 CONTRACT DATA REQUIREMENTS LIST (CDRL) A001
– Incident Reports 
 CDRL A002 – FDA Communications 

CDRL A003 – Technical Data and Study Reports 
 CDRL A004
– Breifing Materials 
 ATTACHMENT A – Statement of Work (SOW) 

Exhibit/Attachment Table of Contents 
  

							
	DOCUMENT TYPE	  	DESCRIPTION	  	PAGES	  	DATE
	Attachment 1	  	Attachment A	  		  	26-AUG-2015
	Attachment 2	  	CDRL A001	  		  	27-AUG-2015
	Attachment 3	  	CDRL A002	  		  	27-AUG-2015
	Attachment 4	  	CDRL A003	  		  	27-AUG-2015
	Attachment 5	  	CDRL A004	  		  	27-AUG-2015EX-10.5

 Exhibit 10.5 
 

 

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 Section 00010 - Solicitation Contract Form 

 

							
	ITEM NO	  	SUPPLIES/SERVICES             QUANTITY             UNIT
                        UNIT PRICE	  	AMOUNT	 
	0001	  		  	$	6,573,992.40	  
		  	 Grant - PR141543
 COST

Clinical Trial Award
 FOB: Destination

PURCHASE REQUEST NUMBER: 0010705626-0001
	  			
		  	                                   
                 ESTIMATED COST	  	$	6,573,992.40	  
		  	 ACRN AA
 CIN: GFEBS001070562600001
	  	$	6,573,992.40	  

 PI NAME & PROPOSAL TITLE 

PRINCIPAL INVESTIGATOR: Dr. Langdon Miller 
 TITLE:
Entolimod: A Medical Countermeasure to Reduce the Risk of Death Following Radiation Exposure 
 ADMINISTERED BY: 

Ayi Ayayi 
 Contract Specialist 

US Army Medical Research Acquisition Activity 
 Phone:
301-619-4018 
 Email: ayi.j.ayayi.civ@mail.mil 

DELIVERY INFORMATION 
  

									
	CLIN	  	DELIVERY DATE	  	QUANTITY	  	SHIP TO ADDRESS	  	DODAAC
	0001	  	 POP 30-SEP-2015 TO
 29-SEP-2018
	  	N/A	  	 FORT DETRICK - CDMRP
 FORT DETRICK - CDMRP

1120 FORT DETRICK
 FREDERICK MD 21702

FOB: Destination
	  	W91ZSQ

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 Section 00800 - Special Contract Requirements 

ACCOUNTING AND APPROPRIATION DATA 
  

					
	 AA: 09720142015013000018310440400410
 COST CODE:
A7444
 AMOUNT: $6,573,992.40

CIN GFEBS001070562600001: $6,573,992.40
	  	R.0004371.4.1.10	  	6100.9000021001

 CLAUSES INCORPORATED BY FULL TEXT 

U.S. ARMY MEDICAL RESEARCH AND MATERIEL COMMAND (USAMRMC) 

U. S. ARMY MEDICAL RESEARCH ACQUISITION ACTIVITY (USAMRAA) 

TERMS AND CONDITIONS FOR ASSISTANCE AGREEMENTS 

WITH FOR-PROFIT ORGANIZATIONS 

Effective February 2015 
 AWARD
SPECIFIC TERMS AND CONDITIONS 
 This award is a grant made under the authority of 10 U.S.C. 2358 and 10 U.S.C. 2371. The recipient’s statement of
work and the revised budget dated 16 July 2015 for the application submitted in response to the Fiscal Year 2014 Department of Defense (DoD) Peer Reviewed Medical Research Program, Clinical Trial Award Announcement (Funding Opportunity
Announcement Number W81XWH-14-PRMRP-CTA, which closed 17 October 2014) are incorporated herein by reference. 
 CATALOG OF FEDERAL DOMESTIC
ASSISTANCE NUMBER: 12.420 
 TERMS AND CONDITIONS INCORPORATED BY REFERENCE 

This award is governed by provisions of Chapter I, Subchapter C of Title 32, Code of Federal Regulations (CFR), “DoD Grant and Agreement Regulations”
(DoDGARs), other than Parts 32 and 33, incorporated herein by reference, with applicability as stated in those provisions. 
 Also, the guidance in 2 CFR
Part 200, “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards,” as modified and supplemented by the Department of Defense’s (DoD) interim implementation found at 2 CFR Part 1103,
“Interim Grants and Cooperative Agreements Implementation of Guidance in 2 CFR Part 200” (79 FR 76047, December 19, 2014), are incorporated herein by reference, with applicability as stated in those provisions. 

For commercial organizations and those nonprofit organizations identified in Appendix VIII to 2 CFR Part 200, “Nonprofit Organizations Exempted From
Subpart E – Cost Principles,” the cost principles in Part 31 of Chapter 1 of Title 48, CFR, “Federal Acquisition Regulation” (FAR), and Part 231 of Chapter 2 of Title 48, “Department of Defense FAR Supplement,” are
incorporated herein by reference, with applicability as stated in those provisions. 
 Copies of the above can be obtained from: 

Office of Management and Budget 

EOP Publications Office 

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 New Executive Office Building 

725 17th Street, NW, Room 2200 

Washington, DC 20503 
 Telephone:
(202) 395-7332 
 Website: http://www.whitehouse.gov/omb/ 

ORDER OF PRECEDENCE 
 Any inconsistencies in the
requirements of this award shall be resolved in the following order: 
  

	 	a.	Federal statutes 

  

	 	b.	Federal regulations 

  

	 	c.	2 CFR Part 200, as modified and supplemented by DoD’s interim implementation found at 2 CFR Part 1103 

  

	 	d.	Award-specific terms and conditions 

 ACCEPTANCE OF AWARD 

The recipient is not required to countersign this award. In case of disagreement with any requirements of this award, the recipient shall contact the USAMRAA
Grants Officer in order to resolve the issue(s). The recipient shall not assess any costs to the award or accept any payments until the issue(s) is resolved. 

RECIPIENT RESPONSIBILITY 
 In addition to the
responsibilities of the recipient as defined in the award or incorporated by reference herein: 
 a. The recipient will bear primary
responsibility for the conduct of the research and will exercise sound judgment within the limits of the award’s terms and conditions. 

b. The Principal Investigator (PI) specified in the award document will be continuously responsible for the conduct of the research project and
will be closely involved with the research effort. The PI, in coordination with the recipient’s Office of Sponsored Projects/Business Office, is in the best position to determine the means by which the research may be conducted most
effectively. 
 RESEARCH INTEGRITY AND MISCONDUCT 
 The
recipient shall comply with the requirements of DoD Instruction 3210.7, “Research Integrity and Misconduct,” Enclosure 4, “Requirements for Extramural Research Institutions” (available at:
http://www.dtic.mil/whs/directives/corres/pdf/321007p.pdf), incorporated herein by reference. 
 AWARD MODIFICATION 

The only method by which this award may be modified is by a formal, written modification signed by the USAMRAA Grants Officer. No other communications, whether
oral or in writing, are valid to change the terms and conditions of this award. 
 PRIOR APPROVAL REQUIREMENTS 

a. Administrative Requirements. Prior approvals required by DoDGAR 34.15 are waived except those identified below. Recipients shall
request prior written approval from the USAMRAA Grants Officer for: 
 (1) Change in the scope or the objectives of the project as stated in
the approved Statement of Work or approved modifications thereto, such as a change in the phenomenon(a) under study, even if there is no associated budget revision. 

(2) The need for additional Federal funding. 

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 (3) Change in the PI or any key personnel specified in the award document. 

(4) The absence for more than 3 months, or a 25 percent reduction in time devoted to the project, by the approved PI or Project Director. 

(5) The inclusion of pre-award costs. 

(6) The subaward, transfer, or contracting out of any work not approved under the original award. This provision does not apply to the purchase
of supplies, materials, equipment, or general support services, except that procurement of equipment or other capital items of property always is subject to the USAMRAA Grants Officer’s prior approval under DoDGAR 34.21(a) or DoDGAR
34.13(a)(7). 
 (7) Expenditures for individual items of general-purpose equipment and specific-purpose equipment, costing $5,000 or more,
unless identified in the budget that is incorporated as part of the award. 
 (8) The transfer of funds among direct cost categories,
functions and activities for awards in which the Federal share of the project exceeds $100,000 and the cumulative amount of such transfers exceeds or is expected to exceed 10 percent of the total budget as last approved by the USAMRAA Grants
Officer. A transfer that would cause any Federal appropriation or part thereof to be used for purposes other than those consistent with the original intent of the appropriation is prohibited. 

b. Cost Principles. Recipients shall request prior written approval from the USAMRAA Grants Officer for the inclusion of costs that
require prior approval in accordance with 48 CFR Parts 31 and 231, 2 CFR Part 200 Subpart E, and 45 CFR Part 74 Appendix E, as applicable. In accordance with those cost principles, the recipient must request prior written approval from the USAMRAA
Grants Officer for: (1) those selected items of cost requiring prior approval; and (2) the incurrence of special or unusual costs. 
 CHANGE IN
PERFORMANCE PERIOD 
 In accordance with the DoDGAR 34.15(c)(2)(v), the recipient may initiate, without prior approval, a one-time extension without
funds to the expiration date of the award, as long as the extension without funds does not involve a change in the approved objectives or scope of the project. The recipient shall notify the USAMRAA Grants Officer in writing at least 10 calendar
days prior to the expiration date of the award. The notification shall state: the additional time needed, up to a maximum of 12 months; the reasons for the extension; and the work to be completed during the extension period. The recipient must be
current with all financial and technical reporting requirements and be in compliance with all other terms and conditions of the award. This one-time extension without funds may not be exercised merely for the purpose of using unobligated balances.
An official modification to the award document must be issued by the USAMRAA Grants Officer to extend the period of performance. 
 UNOBLIGATED BALANCES

 The recipient is authorized to carry forward unobligated balances to subsequent funding periods of the award agreement without prior written approval.

 MAXIMUM OBLIGATION 
 The maximum obligation of the
Government for support of this award will not exceed the amount specified in the award, as modified. Awards will not be modified to provide additional funds for such purposes as reimbursement for unrecovered indirect costs resulting from the
establishment of final negotiated rates or for increases in salaries, fringe benefits, and other costs. 

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 FEE AND PROFIT 

In accordance with 32 CFR 22.205(b), fee or profit is not an allowable cost for the recipient or under a subaward at any tier. 

DISALLOWED COSTS 
 Funds shall not be used for the support
of any costs disallowed by the Funding Opportunity Announcement, either as a direct or an indirect cost. 
 SUPPORTING INFORMATION 

Information such as subawards, consultant agreements, vendor quotes, and personnel work agreements may be required in order to support proposed costs or to
determine the employment status of personnel. The Government’s receipt of this information does not constitute approval or acceptance of any term or condition included therein. 

FINANCIAL INSTABILITY, INSOLVENCY, BANKRUPTCY OR RECEIVERSHIP 

a. The recipient shall immediately notify the USAMRAA Grants Officer of the occurrence of the following events: (1) the recipient’s
financial instability that would negatively impact performance of this award; (2) the recipient’s or recipient’s parent’s filing of a voluntary case seeking liquidation or reorganization under the Bankruptcy Act; (3) the
recipient’s consent to the institution of an involuntary case under the Bankruptcy Act against the organization or organization’s parent; (4) the filing of any similar proceeding for or against the recipient or recipient’s
parent, or its consent to, the dissolution, winding-up or readjustment of the recipient’s debts, appointment of a receiver, conservator, trustee, or other officer with similar powers over the organization, under any other applicable state or
federal law; or (5) the recipient’s insolvency due to its inability to pay its debts generally as they become due. 
 b. Such
notification shall be in writing and shall: (1) specifically set out the details of the occurrence of an event referenced in paragraph “a”; (2) provide the facts surrounding that event; and (3) provide the impact such event
will have on the project being funded by this award. 
 c. Upon the occurrence of any of the five events described in paragraph “a”
above, the Government reserves the right to conduct a review of this award to determine the recipient’s compliance with the required elements of the award (including such items as cost share, progress towards technical project objectives, and
submission of required reports). If the USAMRAA Grants Officer’s review determines that there are significant deficiencies or concerns with the recipient’s performance under the award, the Government reserves the right to impose additional
requirements, as needed, including (1) change the payment method; (2) institute payment controls, and (3) require additional reporting requirements. 

d. Failure of the recipient to comply with this term may be considered a material failure by the recipient to comply with the terms of this
award and may result in termination. 
 PROPERTY STANDARDS 

The recipient shall manage, use and dispose of property in accordance with the requirements established in DoDGAR 34.20 through 34.24. 

TITLE TO REAL PROPERTY AND EQUIPMENT 
 The purchase of
real property or equipment acquired in whole or in part with Federal funds requires prior approval of the USAMRAA Grants Officer. Title to such real property or equipment vests in the recipient upon acquisition, subject to the conditions of DoDGAR
34.21. 
 FEDERALLY OWNED PROPERTY 
 Title to
Federally-owned property vests in the Federal Government. DoDGAR 34.22 governs the requirements for Federally-owned property. 

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 PROPERTY MANAGEMENT SYSTEM 

The recipient’s property management system for property that is Federally-owned and for equipment that is acquired in whole or in part with Federal funds,
or that is used as matching share, is subject to the requirements of DoDGAR 34.23. 
 SUPPLIES 

Title to supplies acquired with Federal funds under this award vests in the recipient upon acquisition. Upon completion or termination of the project,
disposition of supplies shall be handled in accordance with DoDGAR 34.24. 
 INTANGIBLE PROPERTY - DATA AND SOFTWARE REQUIREMENTS 

Rights in technical data, patents, inventions, and computer software are subject to the requirements of DoDGAR 34.25. All software and data first produced
under the award are subject to the Federal Purpose license in accordance with applicable DoDGAR requirements. The recipient grants to the Government all necessary and appropriate licenses as a condition of this award. 

PATENTS AND INVENTIONS REPORTING REQUIREMENTS 

a. iEdison and annual reporting. The recipient shall electronically file Invention Disclosures and Patent Applications using the Interagency
Edison (iEdison) system through the National Institutes of Health (https://s-edison.info.nih.gov/iEdison) within the times specified for reporting. In addition, inventions made during the year shall also be reported annually (within 30 days
of the anniversary date of the award) on a DD Form 882, “Report of Inventions and Subcontracts.” If there are no inventions during the year, no annual DD Form 882 is required. The DD Form 882 can be accessed at
https://www.usamraa.army.mil. 
 b. Closeout report. A final DD Form 882 is required. The form shall be submitted electronically
within 90 days of end of the term of award. List all inventions made during the term of the award, or state “none,” as applicable. The award will NOT be closed until all reporting requirements have been met. 

c. All reports shall be sent electronically to usarmy.detrick.medcom-usamraa.mbx.aa2@mail.mil.  

FINANCIAL REPORTING REQUIREMENTS 
 The recipient shall use
the Standard Form (SF) 425, “Federal Financial Report,” for reporting individual awards. Quarterly and final reports are required for those awards receiving advance payments. Annual and final reports are required for those awards receiving
cost reimbursement payments. 
 The Federal Financial Reporting period end dates fall on the end of the calendar quarter for quarterly reports (3/31, 6/30,
9/30, 12/31), end of the calendar year for annual reports (12/31), and the end date of the term of award for the final report. Quarterly reports shall be submitted no later than 30 days after the end of each quarter. Annual reports shall be
submitted no later than 90 days after the end of the calendar year. Final reports shall be submitted no later than 90 days after the end date of the term of award. 

Submission Instructions: 
 a. All SF425
reports must be submitted electronically through the web site https://www.usamraa.army.mil/pages/sf425. The form and instructions can be obtained on this site. 

b. Do not report multiple awards on one report. Each award must be reported separately on its own SF425. 

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 Do not combine multiple SF425s into one submission. Each form must be saved as a separate PDF and submitted
individually. 
 AUDITS 
 Any recipient that expends
$500,000 or more in a year under Federal awards shall have an audit made by an independent auditor in accordance with the requirements of DoDGAR 34.16. The recipient shall make the auditor’s report available upon request. 

CLINICAL TRIAL REGISTRY 
 Certain clinical trials are
required by U.S. law to be registered on the National Institutes of Health database entitled “ClinicalTrials.gov.” For those trials required to be registered (see http://prsinfo.clinicaltrials.gov/, “Support Materials, including Data
Element Definitions”), PIs shall register clinical trials individually on http://www.clinicaltrials.gov. PIs shall use a Secondary Protocol ID number designation of “(enter CDMRP-CDMRP Log Number)” (e.g., CDMRP-BC151111). If several
protocols exist under the same application, the Secondary Protocol ID number must be designated “CDMRP-CDMRP Log Number-A, B, C, etc.” (e.g., CDMRP-BC151111-A). Clinical trials must be registered prior to enrollment of the first patient.
Failure to do so may result in a civil monetary penalty and/or the withholding or recovery of award funds as per U.S. Public Law 110-85. 
 QUARTERLY
TECHNICAL REPORTING REQUIREMENTS 
 For each year of the entire performance period of the award, the PI shall submit a Quarterly Technical Progress
Report covering research results (positive and negative data) during each of the first three quarters. A Quarterly Technical Progress Report for the fourth quarter is not required, as the Annual Technical Report shall incorporate all four quarters
of progress. 
 Quarterly reports are the most immediate and direct contact between the PI and the Grants Officer’s Representative (GOR). The reports
provide the means for keeping the USAMRMC advised of developments and problems as the research effort proceeds. The reports also provide a measure against which funding decisions are made. 

The Quarterly Technical Progress Report Format, available on web site https://www.usamraa.army.mil, is required. Each item of the report format shall
be completed. 
 Each report shall be submitted electronically, within 15 days after the end of each quarter, to the Grants Specialist and the GOR at the
e-mail addresses specified below. Name your file with your award number, followed by Year X Quarter Y Report (example: W81XWH-15-1-0000 Year 1 Quarter 1 Report.) If you have questions, contact the GOR. 

Grants Specialist E-mail: usarmy.detrick.medcom-usamraa.mbx.aa2@mail.mil 

GOR E-mail: usarmy.detrick.medcom-cdmrp.mbx.cdmrp-reporting@mail.mil 

The Quarterly Technical Progress Report shall be brief, factual, and informal, and shall be prepared in accordance with the following: 

 

	 	(1)	FRONT COVER: 

  

	 	(a)	Award Number: 

  

	 	(b)	Log Number: 

  

	 	(c)	Project Title: 

  

	 	(d)	Principal Investigator Name: 

  

	 	(e)	Principal Investigator Organization and Address: 

  

	 	(f)	Principal Investigator Phone and Email: 

  

	 	(g)	Report Date: 

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	 	(h)	Report Period: 

  

	 	(2)	SECTION 1 — Accomplishments: The PI is reminded that the recipient organization is required to obtain prior written approval from the USAMRAA Grants Officer whenever there are significant changes in the
project or its direction. 

  

	 	•	 	What were the major goals of the project? 

  

	 	•	 	What was accomplished under these goals? 

  

	 	•	 	Describe the Regulatory Protocol and Activity Status (if applicable). 

  

	 	•	 	What do you plan to do during the next reporting period to accomplish the goals and objectives?  

What were the major goals of the project? 

List the major goals of the project as stated in the approved SOW. If the application listed milestones/target dates for important activities
or phases of the project identify these dates and show actual completion dates or the percentage of completion. 
 What was accomplished
under these goals? 
 For this quarterly reporting period only describe: 1) major activities; 2) specific objectives; 3)
significant results or key outcomes, including major findings, developments, or conclusions (both positive and negative); and/or 4) other achievements. Include a discussion of stated goals not met. Description shall include pertinent data and graphs
in sufficient detail to explain any significant results achieved. A succinct description of the methodology used shall be provided. 

Describe the Regulatory Protocol and Activity Status (if applicable). 

Describe the Protocol and Activity Status for sections a-c, as applicable, using the format described for each section. If there is nothing
significant to report during this reporting period, state “Nothing to Report.” 
  

	 	(a)	Human Use Regulatory Protocols 

 TOTAL PROTOCOL(S): State the total number of
human use protocols required to complete this project (e.g., “5 human subject research protocols will be required to complete the Statement of Work”). If not applicable, write “No human subjects research will be performed to complete
the Statement of Work.” 
 PROTOCOL(S): List the identifier and title for all human use protocols needed to complete the
project. Include information about the approved target number for clinical significance, type of submission, type of approval with associated dates, and performance status. 

The following format shall be used: 

Protocol of total: 

Human Research Protection Office (HRPO) assigned A-number: 

Title: 
 Target required for
clinical significance: 
 Target approved for clinical significance: 

Submitted to and Approved by: Provide a bullet point list of protocol development, submission, amendments, and approvals
(include IRB in addition to HRPO). 
 Status: Report on activity status: (i) progress on subject recruitment, screening,
enrollment, completion, and numbers of each compared to original planned target(s), e.g., number of subjects enrolled versus total number proposed (ii) amendments submitted to the IRB and USAMRMC HRPO for review; and (iii) any adverse
event/unanticipated problems involving risks to subjects or others and actions or plans for mitigation. 

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	 	(b)	Use of Human Cadavers for Research Development Test & Evaluation (RDT&E), Education or Training 

“Cadaver” is defined as a deceased person or portion thereof, and is synonymous with the terms “human cadaver” and
“post-mortem human subject” or “PMHS.” The term includes organs, tissues, eyes, bones, arteries or other specimens obtained from an individual upon or after death. The term “cadaver” does not include portions of an
individual person, such as organs, tissue or blood, that were removed while the individual was alive (for example, if a living person donated tissue for use in future research protocols, that tissue is not considered a “cadaver” under this
policy, regardless of whether the donor is living or deceased at the time of tissue use). 
 TOTAL ACTIVITIES: State the total number
of RDT&E, education or training activities that will involve cadavers. If not applicable, write “No RDT&E, education or training activities involving human cadavers will be performed to complete the Statement of Work (SOW).” 

ACTIVITIES: Provide the following information in a bulleted list for all RDT&E, education or training activities involving human
cadavers conducted or supported during the quarter: 
  

	 	•	 	Title of the RDT&E, education or training activity 

  

	 	•	 	SOW task/aim associated with the activity 

  

	 	•	 	Date the activity was conducted 

  

	 	•	 	Identification of the organization’s responsible individual (e.g., PI or individual primarily responsible for the activity’s conduct) 

 

	 	•	 	Brief description of the use(s) of cadavers in the activity and the total number of cadavers used during the reporting period 

  

	 	•	 	Brief description of the Department of Army organization’s involvement in the activity 

  

	 	•	 	Status of document submission and approvals 

  

	 	•	 	Problems encountered in the procurement, inventory, use, storage, transfer, transportation and disposition of cadavers used for RDT&E, education or training. Examples of problems include but are not limited to: loss
of confidentiality of cadaveric donors, breach of security, significant deviation from the approved protocol, failure to comply with state laws and/or institutional policies and public relations issues. 

 

	 	(c)	Animal Use Regulatory Protocols 

 TOTAL PROTOCOL(S): State the total number of
animal use protocols required to complete this project (e.g., “2 animal use research protocols will be required to complete the Statement of Work”). If not applicable, write “No animal use research will be performed to complete the
Statement of Work.” 
 PROTOCOL(S): List the identifier and title for all animal use protocols needed to complete the project.
Include information about the approved target number for statistical significance, type of submission, type of approval with associated dates, and performance status. 

The following format shall be used: 

Protocol of total: 

Animal Care and Use Review Office (ACURO) assigned Number: 

Title: 
 Target required for
statistical significance: 
 Target approved for statistical significance: 

Submitted to and Approved by: Provide a bullet point list of protocol development, submission, amendments, and approvals
(include Institutional Animal Care and Use Committee (IACUC) in addition to ACURO). 

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 Status: Provide a bullet point list of performance and/or progress status
relating to the above protocol and discuss any administrative, technical, or logistical issues that may impact performance or progress of the study (e.g., animal use protocol needs revision to minimize animal suffering, animal protocol modification
to include additional staff) for the above ACURO approved protocol. 
  

	 	  	What do you plan to do during the next reporting period to accomplish the goals and objectives? 

Describe briefly what you plan to do during the next reporting period to accomplish the goals and objectives in accordance with the approved
SOW. 
  

	 	(3)	SECTION 2 - Products: List any products resulting from the project during the reporting period. If there are no products to report for the current quarter, state “Nothing to report.” 

Examples of products include: 
  

	 	•	 	publications, conference papers, and presentations; 

  

	 	•	 	website(s) or other Internet site(s); 

  

	 	•	 	technologies or techniques; 

  

	 	•	 	inventions, patent applications, and/or licenses; and 

  

	 	•	 	other products, such as data or databases, biospecimen collections, germplasm, audio or video products, software, models, educational aids or curricula, instruments or equipment, data and research material, clinical or
educational interventions, or new business creation. 

  

	 	(4)	SECTION 3 - Participants & Other Collaborating Organizations 

 What
individuals have worked on the project? 
 Provide the following information for: (1) PDs/PIs; and (2) each person who has
worked at least one person month per year on the project during the reporting period, regardless of the source of compensation (a person month equals approximately 160 hours of effort). 

Provide the name and identify the role the person played in the project. Indicate the nearest whole person month (Calendar, Academic,
Summer) that the individual worked on the project. Show the most senior role in which the person worked on the project for any significant length of time. For example, if an undergraduate student graduated, entered graduate school, and continued to
work on the project, show that person as a graduate student, preferably explaining the change in involvement. 
 Describe how this person
contributed to the project. If information is unchanged from a previous submission, provide the name only and indicate “no change”. 
  

			
	Example:	  	
	 Name:
 Project Role:

Researcher Identifier (e.g., ORCID ID):
 Nearest person month
worked:
 Contribution to Project:
	  	 Mary Smith
 Graduate Student

1234567
 5

Ms. Smith has performed work in the area of combined error-control and constrained coding

  

	 	(5)	SECTION 4 - Changes/Problems: The PD/PI is reminded that the recipient organization is required to obtain prior written approval from the awarding agency Grants Officer whenever there are significant changes in
the project or its direction. If not previously reported in writing, provide the following additional information or state, “Nothing to Report,” if applicable: 

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 1. Actual Problems or delays and actions to resolve them 

Provide a description of current problems or issues that may impede performance or progress of this project along with proposed corrective
action. Also describe changes during the reporting period that may have had a significant impact on expenditures, for example, delays in hiring staff or favorable developments that enable meeting objectives at less cost than anticipated. 

For an award that includes the recruitment of human subjects for clinical research or a clinical trial, discuss any problems or barriers
encountered, if applicable, and what has been done to mitigate those issues. Discussion may highlight enrollment problems, retention problems, and actions taken to increase enrollment and/or improve retention. 

2. Anticipated Problems/Issues 

Provide a description of anticipated problems or issues that have a potential to impede performance or progress. Also provide course of
actions planned to mitigate problems or to take should the problem materialize. 
  

	 	(6)	SECTION 5 - Special Reporting Requirements: 

 Quad Charts: The Quad Chart
(available on https://www.usamraa.army.mil) shall be updated and submitted as an attachment to the Quarterly Technical Report. 
 ANNUAL/FINAL TECHNICAL
REPORTING REQUIREMENTS 
 Format Requirements: 

a. Annual reports shall be prepared in accordance with the Research Performance Progress Report (RPPR). The RPPR is the uniform format for
reporting performance progress on Federally-funded research projects and research-related activities. Annual reports shall provide a complete summary of the research results (positive or negative) to date in direct alignment to the approved
Statement of Work (SOW). The importance of the report to decisions relating to continued support of the research cannot be over-emphasized. An annual report shall be submitted within 30 calendar days of the anniversary date of the award for the
preceding 12 month period. If the award period of performance is extended by the USAMRAA Grants Officer, then an annual report shall still be submitted within 30 days of the anniversary date of the award. A final report will be due upon completion
of the extended performance date that describes the entire research effort. 
 b. A final report shall also be prepared in accordance with
the RPPR and shall be submitted within 90 calendar days of the award performance end date. The report shall summarize the entire research effort, citing data in the annual reports and appended publications. 

Although there is no page limitation for the reports, each report shall be of sufficient length to provide a thorough description of the accomplishments with
respect to the approved SOW. Reports, in electronic format (PDF or Word file only), shall be submitted to https://ers.amedd.army.mil. 
 All reports
shall have the following elements, in this order: 
 FRONT COVER: 

Sample front cover is provided at  

http://mrmc.amedd.army.mil/index.cfm?pageid=researcher_resources.technical_reporting. The Accession Document (AD) Number should remain
blank. 
 Distribution: Reports must include one of two distribution statements: 

(1) Unlimited Distribution: If the distribution will be unlimited (i.e., approved for public release), choose the form entitled
“Award/Contract Front Cover - Unlimited Distribution A.” Results of fundamental research should be public distribution except in rare and exceptional circumstances. 

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 (2) Limited Distribution: If the distribution is to be limited, choose the form entitled
“Award/Contract Cover—Limited Distribution B.” After report submission, the GOR will review the appropriateness of using this distribution statement. The GOR has the right to challenge the validity of any restrictive markings. Reports
that may be eligible for limited distribution may be ones that contain proprietary data that is not to be released to the public. If so, mark the cover page as “Proprietary”. DO NOT USE THE WORD “CONFIDENTIAL” WHEN MARKING
DOCUMENTS. The recipient shall maintain records sufficient to justify the validity of any restrictive markings. REPORTS NOT PROPERLY MARKED WILL BE DISTRIBUTED AS APPROVED FOR PUBLIC RELEASE. 

For additional information regarding distribution statements, see DOD Instruction 5230.24 (available at  

http://www.dtic.mil/whs/directives). 
 For general
information regarding report preparation, access the Research Resources, Technical Reporting, website at  

https://mrmc.amedd.army.mil/index.cfm?pageid=researcher_resources.technical_reporting. 

STANDARD FORM 298: Sample SF 298 is provided at 

http://mrmc.amedd.army.mil/index.cfm?pageid=researcher_resources.technical_reporting. The abstract shall be provided in Block 14 and shall state the
purpose, scope, and major findings and be an up-to-date report of the progress in terms of results and significance. Abstracts will be submitted to the Defense Technical Information Center (DTIC) and shall not contain proprietary information.
Subject terms are keywords that may have been previously assigned to the proposal abstract or are keywords that may be significant to the research. 
 Pages
shall be numbered. The number of pages shall include all pages that have printed data (including the front cover, SF 298, table of contents, and all appendices). Page numbers must match the numbering shown on the Table of Contents. 

TABLE OF CONTENTS: Sample table of contents is provided at  

http://mrmc.amedd.army.mil/index.cfm?pageid=researcher_resources.technical_reporting. 

Example Table of Contents 
  

			
	 	  	Page No.
	1. Introduction	  	
	2. Keywords	  	
	3. Accomplishments	  	
	4. Impact	  	
	5. Changes/Problems	  	
	6. Products	  	
	7. Participants & Other Collaborating Organizations	  	
	8. Special Reporting Requirements	  	
	9. Appendices	  	

 1. INTRODUCTION: Narrative that briefly (one paragraph) describes the subject, purpose and scope of the research. 

2. KEYWORDS: Provide a brief list of keywords (limit to 20 words). 

3. ACCOMPLISHMENTS: The PI is reminded that the recipient organization is required to obtain prior written approval from the USAMRAA Grants Officer
whenever there are significant changes in the project or its direction. 
  

	 	•	 	What were the major goals and objectives of the project? 

  

	 	•	 	What was accomplished under these goals? 

  

	 	•	 	What opportunities for training and professional development did the project provide? 

  

	 	•	 	How were the results disseminated to communities of interest? 

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	 	•	 	What do you plan to do during the next reporting period to accomplish the goals and objectives? 

 What were
the major goals of the project? 
 List the major goals of the project as stated in the approved SOW. If the application listed milestones/target dates
for important activities or phases of the project, identify these dates and show actual completion dates or the percentage of completion. 
 Generally, the
goals will not change from one reporting period to the next and are unlikely to change during the final reporting period. However, if the awarding agency approved changes to the goals during the reporting period, list the revised goals and
objectives. Also explain any significant changes in approach or methods from the agency approved application or plan. 
 What was accomplished under
these goals? 
 For this reporting period describe: 1) major activities; 2) specific objectives; 3) significant results or key outcomes, including major
findings, developments, or conclusions (both positive and negative); and/or 4) other achievements. Include a discussion of stated goals not met. Description shall include pertinent data and graphs in sufficient detail to explain any significant
results achieved. A succinct description of the methodology used shall be provided. As the project progresses to completion, the emphasis in reporting in this section should shift from reporting activities to reporting accomplishments. 

What opportunities for training and professional development has the project provided? 

If the project was not intended to provide training and professional development opportunities or there is nothing significant to report during this reporting
period, state “Nothing to Report.” 
 Describe opportunities for training and professional development provided to anyone who worked on the
project or anyone who was involved in the activities supported by the project. “Training” activities are those in which individuals with advanced professional skills and experience assist others in attaining greater proficiency. Training
activities may include, for example, courses or one-on-one work with a mentor. “Professional development” activities result in increased knowledge or skill in one’s area of expertise and may include workshops, conferences, seminars,
study groups, and individual study. Include participation in conferences, workshops, and seminars not listed under major activities. 
 How were the
results disseminated to communities of interest? 
 If there is nothing significant to report during this reporting period, state “Nothing to
Report.” 
 Describe how the results were disseminated to communities of interest. Include any outreach activities that were undertaken to reach
members of communities who are not usually aware of these project activities, for the purpose of enhancing public understanding and increasing interest in learning and careers in science, technology, and the humanities. 

What do you plan to do during the next reporting period to accomplish the goals? 

If this is the final report, state “Nothing to Report.” 

Describe briefly what you plan to do during the next reporting period to accomplish the goals and objectives. 

4. IMPACT: This component is used to describe ways in which the work, findings, and specific products of the project have had an impact during this
reporting period. Describe distinctive contributions, major accomplishments, innovations, successes, or any change in practice or behavior that has come about as a result of the project relative to: 

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	 	•	 	the development of the principal discipline(s) of the project; 

  

	 	•	 	other disciplines; 

  

	 	•	 	technology transfer; or 

  

	 	•	 	society beyond science and technology. 

 What was the impact on the development of the principal
discipline(s) of the project? 
 If there is nothing significant to report during this reporting period, state “Nothing to Report.” 

Describe how findings, results, techniques that were developed or extended, or other products from the project made an impact or are likely to make an impact
on the base of knowledge, theory, and research in the principal disciplinary field(s) of the project. Summarize using language that an intelligent lay audience can understand (Scientific American style). 

How the field or discipline is defined is not as important as covering the impact the work has had on knowledge and technique. Make the best distinction
possible, for example, by using a “field” or “discipline,” if appropriate, that corresponds with a single academic department (i.e., physics rather than nuclear physics). 

What was the impact on other disciplines? 
 If there is
nothing significant to report during this reporting period, state “Nothing to Report.” 
 Describe how the findings, results, or techniques that
were developed or improved, or other products from the project made an impact or are likely to make an impact on other disciplines. 
 What was the
impact on technology transfer? 
 If there is nothing significant to report during this reporting period, state “Nothing to Report.” 

Describe ways in which the project made an impact, or is likely to make an impact, on commercial technology or public use, including: 

 

	 	•	 	transfer of results to entities in government or industry; 

  

	 	•	 	instances where the research has led to the initiation of a start-up company; or 

  

	 	•	 	adoption of new practices. 

 What was the impact on society beyond science and technology? 

If there is nothing significant to report during this reporting period, state “Nothing to Report.” 

Describe how results from the project made an impact, or are likely to make an impact, beyond the bounds of science, engineering, and the academic world on
areas such as: 
  

	 	•	 	improving public knowledge, attitudes, skills, and abilities; 

  

	 	•	 	changing behavior, practices, decision making, policies (including regulatory policies), or social actions; or 

  

	 	•	 	improving social, economic, civic, or environmental conditions. 

 5. CHANGES/PROBLEMS: The Project
Director/Principal Investigator (PD/PI) is reminded that the recipient organization is required to obtain prior written approval from the awarding agency Grants Officer whenever there are significant changes in the project or its direction. If not
previously reported in writing, provide the following additional information or state, “Nothing to Report,” if applicable: 
  

	 	•	 	Changes in approach and reasons for change. 

  

	 	•	 	Actual or anticipated problems or delays and actions or plans to resolve them. 

  

	 	•	 	Changes that have a significant impact on expenditures. 

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	 	•	 	Significant changes in use or care of human subjects, vertebrate animals, biohazards, and/or select agents.  

Changes in approach and reasons for change 
 Describe any
changes in approach during the reporting period and reasons for these changes. Remember that significant changes in objectives and scope require prior approval of the agency. 

Actual or anticipated problems or delays and actions or plans to resolve them 

Describe problems or delays encountered during the reporting period and actions or plans to resolve them. 

Changes that had a significant impact on expenditures 

Describe changes during the reporting period that may have had a significant impact on expenditures, for example, delays in hiring staff or favorable
developments that enable meeting objectives at less cost than anticipated. 
 Significant changes in use or care of human subjects, vertebrate animals,
biohazards, and/or select agents 
 Describe significant deviations, unexpected outcomes, or changes in approved protocols for the use or care of human
subjects, vertebrate animals, biohazards, and/or select agents during the reporting period. If required, were these changes approved by the applicable institution committee (or equivalent) and reported to the agency? Also specify the applicable
Institutional Review Board/Institutional Animal Care and Use Committee approval dates. 
  

	6.	PRODUCTS: List any products resulting from the project during the reporting period. Examples of products include: 

  

	 	•	 	publications, conference papers, and presentations; 

  

	 	•	 	website(s) or other Internet site(s); 

  

	 	•	 	technologies or techniques; 

  

	 	•	 	inventions, patent applications, and/or licenses; and 

  

	 	•	 	other products. 

 If there is nothing to report under a particular item, state “Nothing to Report.”

  

	 	•	 	Publications, conference papers, and presentations 

 Report only the major publication(s)
resulting from the work under this award. There is no restriction on the number. However, agencies are interested in only those publications that most reflect the work under this award in the following categories: 

Journal publications. List peer-reviewed articles or papers appearing in scientific, technical, or professional journals. Include any
peer-reviewed publication in the periodically published proceedings of a scientific society, a conference, or the like. A publication in the proceedings of a one-time conference, not part of a series, should be reported under “Books or other
non-periodical, one-time publications.” 
 Identify for each publication: Author(s); title; journal; volume: year; page numbers; status
of publication (published; accepted, awaiting publication; submitted, under review; other); acknowledgement of federal support (yes/no). 

Books or other non-periodical, one-time publications. Report any book, monograph, dissertation, abstract, or the like published as or in
a separate publication, rather than a periodical or series. Include any significant publication in the proceedings of a one-time conference or in the report of a one-time study, commission, or the like. 

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 Identify for each one-time publication: Author(s); title; editor; title of collection, if
applicable; bibliographic information; year; type of publication (e.g., book, thesis or dissertation); status of publication (published; accepted, awaiting publication; submitted, under review; other); acknowledgement of federal support (yes/no).

 Other publications, conference papers, and presentations. Identify any other publications, conference papers and/or presentations
not reported above. Specify the status of the publication as noted above. List presentations made during the last year (international, national, local societies, military meetings, etc.). Use an asterisk (*) if presentation produced a
manuscript. 
  

	 	•	 	Website(s) or other Internet site(s) 

 List the URL for any Internet site(s) that disseminates the
results of the research activities. A short description of each site should be provided. It is not necessary to include the publications already specified above in this section. 

 

	 	•	 	Technologies or techniques 

 Identify technologies or techniques that resulted from the research
activities. In addition to a description of the technologies or techniques, describe how they will be shared. 
  

	 	•	 	Inventions, patent applications, and/or licenses 

 Identify inventions, patent applications with
date, and/or licenses that have resulted from the research. State whether an application is provisional or non-provisional and indicate the application number. Submission of this information as part of an interim research performance progress report
is not a substitute for any other invention reporting required under the terms and conditions of an award. 
  

	 	•	 	Other Products 

 Identify any other reportable outcomes that were developed under this project.
Reportable outcomes are defined as a research result that is or relates to a product, scientific advance, or research tool that makes a meaningful contribution toward the understanding, prevention, diagnosis, prognosis, treatment, and/or
rehabilitation of a disease, injury or condition, or to improve the quality of life. Examples include: 
  

	 	•	 	data or databases; 

  

	 	•	 	biospecimen collections; 

  

	 	•	 	audio or video products; 

  

	 	•	 	software; 

  

	 	•	 	models; 

  

	 	•	 	educational aids or curricula; 

  

	 	•	 	instruments or equipment; 

  

	 	•	 	research material (e.g., Germplasm; cell lines, DNA probes, animal models); 

  

	 	•	 	clinical interventions; 

  

	 	•	 	new business creation; and 

  

	 	•	 	other. 

 7. PARTICIPANTS & OTHER COLLABORATING ORGANIZATIONS 

Provide the following information on participants: 
  

	 	•	 	what individuals have worked on the project? 

  

	 	•	 	has there been a change in the other active support of the PD/PI(s) or senior/key personnel since the last reporting period? 

  

	 	•	 	what other organizations have been involved as partners? 

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 What individuals have worked on the project? 

Provide the following information for: (1) PDs/PIs; and (2) each person who has worked at least one person month per year on the project during the
reporting period, regardless of the source of compensation (a person month equals approximately 160 hours of effort). 
  

	 	•	 	Provide the name and identify the role the person played in the project. Indicate the nearest whole person month (Calendar, Academic, Summer) that the individual worked on the project. Show the most senior role
in which the person worked on the project for any significant length of time. For example, if an undergraduate student graduated, entered graduate school, and continued to work on the project, show that person as a graduate student, preferably
explaining the change in involvement. 

 Describe how this person contributed to the project and with what funding
support. If information is unchanged from a previous submission, provide the name only and indicate “no change”. 
  

			
	Example:	  	
	Name:	  	Mary Smith
	Project Role:	  	Graduate Student
	Researcher Identifier (e.g., ORCID ID):	  	1234567
	Nearest person month worked:	  	5
	Contribution to Project:	  	Ms. Smith has performed work in the area of combined error-control and constrained coding
	Funding Support:	  	The XYZ Foundation (Complete only if the funding support is provided from other than this award.)

 Has there been a change in the active other support of the PD/PI(s) or senior/key personnel since the last reporting
period? 
 If there is nothing significant to report during this reporting period, state “Nothing to Report.” 

If the active support has changed for the PD/PI(s) or senior/key personnel, then describe what the change has been. Changes may occur, for example, if a
previously active grant has closed and/or if a previously pending grant is now active. Annotate this information so it is clear what has changed from the previous submission. 

Submission of other support information is not necessary for pending changes or for changes in the level of effort for active support reported previously. The
awarding agency may require prior written approval if a change in active other support significantly impacts the effort on the project that is the subject of the project report. 

What other organizations were involved as partners? 
 If
there is nothing significant to report during this reporting period, state “Nothing to Report.” 
 Describe partner organizations - academic
institutions, other nonprofits, industrial or commercial firms, state or local governments, schools or school systems, or other organizations (foreign or domestic) – that were involved with the project. Partner organizations may have provided
financial or in-kind support, supplied facilities or equipment, collaborated in the research, exchanged personnel, or otherwise contributed. 
 Provide the
following information for each partnership: 
 Organization Name: 

Location of Organization: (if foreign location list country) 

Partner’s contribution to the project (identify one or more) 
  

	 	•	 	Financial support; 

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	 	•	 	In-kind support (e.g., partner makes software, computers, equipment, etc., available to project staff); 

  

	 	•	 	Facilities (e.g., project staff use the partner’s facilities for project activities); 

  

	 	•	 	Collaboration (e.g., partner’s staff work with project staff on the project); 

  

	 	•	 	Personnel exchanges (e.g., project staff and/or partner’s staff use each other’s facilities, work at each other’s site); and 

 

	 	•	 	Other. 

 8. SPECIAL REPORTING REQUIREMENTS: 

QUAD CHARTS: The Quad Chart (available on https://www.usamraa.army.mil) shall be updated and submitted as an appendix. 

9. APPENDICES: Attach all appendices that contain information that supplements, clarifies or supports the text. Examples include original copies of
journal articles, reprints of manuscripts and abstracts, a curriculum vitae, patent applications, study questionnaires, and surveys, etc. 
 DELINQUENT
REPORTS 
 If the recipient is delinquent on reporting requirements for other USAMRAA-sponsored awards, payments on this award may be withheld until
acceptable delinquent reports have been submitted. No new awards will be issued to the recipient until all delinquent reports are submitted. 

MANUSCRIPTS/REPRINTS 
 Copies of manuscripts or subsequent
reprints resulting from the research shall be submitted to  
 usarmy.detrick.medcom-cdmrp.mbx.cdmrp-reporting@mail.mil. 

ABSTRACTS 
 An abstract suitable for publication in the
proceedings of the DoD meeting to be specified by the CDMRP may be requested. Instructions for the abstract format and submission will be provided prior to the conference. 

PUBLICATION, ACKNOWLEDGEMENT, AND PUBLIC RELEASE 

Publication. The recipient is encouraged to publish results of the research, unless classified, in appropriate media. One copy of each paper shall be
submitted to the GOR simultaneously with its submission for publication. Copies of all publications resulting from the research shall be forwarded to the USAMRAA Grants Officer or Grants Specialist as they become available, even though publication
may in fact occur subsequent to the termination date of the award. 
 Acknowledgment. The recipient agrees that in the release of information
relating to this award such release shall include the statements below, as applicable. “Information” includes, but is not limited to, news releases, articles, manuscripts, brochures, advertisements, still and motion pictures, speeches,
trade association meetings, and symposia. 
 a. “The U.S. Army Medical Research Acquisition Activity, 820 Chandler Street, Fort Detrick
MD 21702-5014 is the awarding and administering acquisition office” and; 
 b. “This work was supported by the Office of the
Assistant Secretary of Defense for Health Affairs through the Peer Reviewed Medical Research Program under Award No. W81XWH-15-1-0570. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily
endorsed by the Department of Defense.” 
 c. “In conducting research using animals, the investigator(s) adheres to the laws of the
United States and regulations of the Department of Agriculture.” 

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 d. “In the conduct of research utilizing recombinant DNA, the investigator adhered to
NIH Guidelines for research involving recombinant DNA molecules.” (http://www.nih.gov) 
 e. “In the conduct of research
involving hazardous organisms or toxins, the investigator adhered to the CDC- NIH Guide for Biosafety in Microbiological and Biomedical Laboratories.” (http://www.cdc.gov/biosafety) 

Public release. Prior to release to the public, the recipient shall notify the USAMRAA Grants Officer and the GOR of the following: planned news
releases, planned publicity, advertising material concerning grant/cooperative agreement work, and planned presentations to scientific meetings. This provision is not intended to restrict dissemination of research information; the purpose is to
inform the USAMRMC of planned public release of information on USAMRMC-funded research, in order to adequately respond to inquiries and to be alert to the possibility of inadvertent release of information which could be taken out of context. 

Failure to include the above statements and adhere to the above regulations, when required, may result in loss of funding and/or termination of this award.

 SITE VISITS 
 The USAMRAA Grants Officer, or
authorized representative, has the right to make site visits to review project accomplishments and to provide such technical assistance as may be required. If any site visit is made by the Government representative on the premises of the recipient
or subrecipient, the recipient shall provide, and shall require its subrecipients to provide, all reasonable facilities and assistance for the safety and convenience of the Government representatives in the performance of their duties. All site
visits and evaluations will be performed in such a manner as will not unduly interfere with or delay the work. 
 REQUEST FOR COST REIMBURSEMENT PAYMENTS
WITH FULL FUNDING 
 a. Payments. Cost reimbursement payments will be made to the recipient upon receipt of a “grant voucher”
(used for grants and cooperative agreements) submitted through the Wide Area Work Flow (WAWF) e-Business Suite in accordance with the Contract Line Item Number (CLIN) structure set forth in this award. It is anticipated that Defense Finance and
Accounting Service (DFAS) will disburse funds within 30 days of receipt of a proper grant voucher. Failure to voucher at least quarterly may raise concerns about research progress and the need for continued funding. 

NOTE: This award is comprised of a clinical study or trial that requires Human Use approval from the USAMRMC Office of Research Protection (ORP). Grant
vouchers may be submitted for costs incurred during the first 12 months. No grant voucher may be submitted thereafter until the recipient provides a copy of the ORP approval notification to the cognizant Grants Specialist at
usarmy.detrick.medcom-usamraa.mbx.aa2@mail.mil. The total amount available for disbursement for the first 12 months is $1,496,902.72. 

b. Electronic Funds Transfer (EFT). All payments will be made by EFT to the recipient’s financial institution account listed in the System
for Award Management (SAM) (located at https://www.sam.gov). Failure to update SAM and ensure your account is in an active status will result in nonpayment. 

c. No payment will be made if the recipient fails to perform, or if the recipient fails to submit the required documents. 

ELECTRONIC PAYMENT INSTRUCTIONS 
 The Wide Area Work Flow
(WAWF) e-Business Suite is the required method to electronically process recipient requests for payments. Once on the WAWF e-Business Suite web site, select the Invoicing, Receipt, Acceptance, and Property Transfer (iRAPT) button to electronically
submit “grant vouchers” (used for both grants and cooperative agreements). Recipients shall (i) register to use WAWF at https://wawf.eb.mil and (ii) ensure an 

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 electronic business point of contact (POC) is designated in the System for Award Management (SAM) site at
https://www.sam.gov within ten (10) calendar days prior to requesting a payment for this award. 
 Questions concerning specific payments should
be directed to the Defense Finance and Accounting Service (DFAS) Indianapolis at 1-888-332-7366. You can also access payment and receipt information using the “myInvoice” button in WAWF at https://wawf.eb.mil. The award number or
grant voucher number will be required to inquire about the status of the payment. 
 The following codes and information are required to initiate the
grant voucher and assure successful flow of WAWF documents. 
 TYPE OF DOCUMENT: Grant Voucher (Used for grants and cooperative
agreements) 
 CAGE CODE: 3MWX2  
 ISSUE BY
DODAAC: W81XWH  
 ADMIN BY DODAAC: W81XWH  

INSPECT BY DODAAC: W81XWH  
 ACCEPT BY DODAAC: W81XWH
 
 SHIP TO DODAAC: W81XWH 
 LOCAL PROCESSING
OFFICE DODDAC: Not Applicable 
 PAYMENT OFFICE FISCAL STATION CODE: HQ0490 

EMAIL POINTS OF CONTACT LISTING: 
 INSPECTOR:
usarmy.detrick.medcom-usamraa.mbx.aa2@mail.mil 
 ACCEPTOR: usarmy.detrick.medcom-usamraa.mbx.aa2@mail.mil 

RECEIVING OFFICE POC: usarmy.detrick.medcom-usamraa.mbx.aa2@mail.mil 

GRANT ADMINISTRATOR: Leave Blank  
 GRANTS OFFICER:
Leave Blank 
 ADDITIONAL CONTACT: usarmy.detrick.medcom-usamraa.mbx.aa2@mail.mil 

AWARD CLOSE OUT 
 a. The following
documents shall be submitted within 90 calendar days of the end of the term of the award: 
 (1) Final SF425, “Federal Financial
Report.” Submit to: https://www.usamraa.army.mil/pages/sf425. Form and instructions are available on the web site. 
 (2) Final
Technical Report. Submit to https://ers.amedd.army.mil. 
 (3) Final DD Form 882, “Report of Inventions and Subcontracts”
(form available on web site https://www.usamraa.army.mil). Submit to usarmy.detrick.medcom-usamraa.mbx.aa2@mail.mil. 
 (4)
Cumulative listing of only the nonexpendable personal property acquired with award funds for which title has not been vested to the recipient, if applicable. This may be submitted on institution letterhead. Submit to  

usarmy.detrick.medcom-usamraa.mbx.aa2@mail.mil. 

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 (5) Statement that there is or is not a residual inventory of unused supplies exceeding
$5,000 in total aggregate value. This may be submitted on institution letterhead. Submit the statement to usarmy.detrick.medcom-usamraa.mbx.aa2@mail.mil. 

b. In the event a final audit has not been performed prior to the closeout of the award, the sponsoring agency retains the right to recover an
appropriate amount after fully considering the recommendations on disallowed costs resulting from the final audit. 
 c. The recipient shall
promptly refund any unspent balances of funds the DoD Component has paid that is not authorized to be retained by the recipient. Make check payable to the U.S. Treasury and mail to: 

USAMRAA 
 Attn: MCMR-AAP-C 

Award No. W81XWH-15-1-0570 
 820
Chandler Street 
 Fort Detrick, Maryland 21702-5014 

TERMINATION AND ENFORCEMENT 
 The USAMRAA Grants Officer
may terminate or suspend, in whole or in part, this agreement by written notice to the recipient upon a finding that the recipient materially fails to comply with the terms and conditions of this agreement, if the recipient materially changes the
objective of the agreement, or if appropriated funds are not available to support the program. However, the USAMRAA Grants Officer may immediately suspend or terminate the award without prior notice when such action is necessary to protect the
interests of the Government. 
 No costs incurred during a suspension period or after the effective date of a termination will be allowable, except those
costs which, in the opinion of the USAMRAA Grants Officer, the recipient could not reasonably avoid or eliminate, or which were otherwise authorized by the suspension or termination notice, provided such costs would otherwise be allowable under the
terms of the award and the applicable Federal cost principles. In no event will the total of payments under a terminated award exceed the amount obligated in the award. 

DISPUTES AND APPEALS 
 The procedures of 32 CFR 22.815
govern for processing recipient claims and disputes and for deciding appeals of a USAMRAA Grants Officer’s decision. 
 Disagreements regarding issues
concerning assistance agreements between the recipient and the USAMRAA Grants Officer shall, to the maximum extent possible, be resolved by negotiation and mutual agreement at the USAMRAA Grants Officer level. If agreement cannot be reached, it is
our policy to use Alternative Dispute Resolution (ADR) procedures that may either be agreed upon by the Government and the recipient in advance of the award or may be agreed upon at the time the parties determine to use ADR procedures. If the
parties cannot agree on the use of ADR procedures, the recipient can submit, in writing, a disputed claim or issue to the USAMRAA Grants Officer. The USAMRAA Grants Officer will consider the claim or disputed issue and prepare a written decision
within 60 calendar days of receipt. The USAMRAA Grants Officer’s decision will be final. The recipient may appeal the decision within 90 calendar days after receipt of such notification. 

Appeals of a USAMRAA Grants Officer’s decision will be resolved by the Head of the Contracting Activity. The decision by the Head of the Contracting
Activity will be final and not subject to further administrative appeal. However, the recipient does not waive any legal remedy, such as formal claims, under Title 28 U.S.C. 1491, by agreeing to such provision. 

The enforcement remedies identified in this section, including suspension and termination, do not preclude a recipient from being subject to debarment and
suspension under 2 CFR Part 1125. 

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 PROHIBITION OF USE OF LABORATORY ANIMALS 

Notwithstanding any other terms and conditions contained in this award or incorporated by reference herein, the recipient is expressly forbidden to use or
subcontract for the use of laboratory animals in any manner whatsoever without the express written approval of the USAMRMC, Animal Care and Use Review Office (ACURO). Written authorization to begin research under the applicable protocol(s) proposed
for this award will be issued in the form of an approval letter from the USAMRMC ACURO to the recipient. Furthermore, modifications to already approved protocols require approval by ACURO prior to implementation. For each fiscal year, the recipient
shall maintain, and upon request from ACURO, submit animal usage information. 
 Non-compliance with any of these terms and conditions may result in
withholding of funds and/or the termination of the award. 
 The Animal Care and Use Office requirements can be accessed at  

https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.acuro. 

PROHIBITION OF USE OF HUMAN SUBJECTS 
 Research under this
award involving the use of human subjects, to include the use of human anatomical substances or identifiable private information, shall not begin until the USAMRMC’s Office of Research Protections (ORP) provides authorization that the research
may proceed. Written approval to begin research will be issued from the USAMRMC ORP, under separate notification to the recipient. Written approval from the USAMRMC ORP is also required for any subrecipient that will use funds from this award to
conduct research involving human subjects. 
 Research involving human subjects shall be conducted in accordance with the protocol submitted to and approved
by the USAMRMC ORP. Complete study records shall be maintained for each human research study and shall be made available for review by representatives of the USAMRMC. Research records shall be stored in a confidential manner so as to protect the
confidentiality of subject information. 
 The recipient is required to adhere to the following reporting requirements: 

Submission of major modifications to the protocol, continuing review documentation, and the final report are required as outlined in the USAMRMC ORP approval
memorandum. 
 Unanticipated problems involving risks to subjects or others, subject deaths related to participation in the research, clinical holds
(voluntary or involuntary), and suspension or termination of this research by the IRB, the institution, the Sponsor, or regulatory agencies, shall be promptly reported to the USAMRMC ORP. 

The knowledge of any pending compliance inspection/visits by the FDA, ORP, or other government agency concerning this clinical investigation or research, the
issuance of Inspection Reports, FDA Form 483, warning letters or actions taken by any Regulatory Agencies including legal or medical actions, and any instances of serious or continuing noncompliance with regulatory requirements that relate to this
clinical investigation or research, shall be reported immediately to the USAMRMC ORP. 
 Non-compliance with these terms and conditions may result in
withholding of funds and/or the termination of the award. 
 DoD requirements for human subjects research, including 32 CFR Part 219, DoD Instruction
3216.02 and the USAMRMC ORP Human Research Protection Office requirements and instructions can be accessed at  

https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.hrpo. 

PROHIBITION OF USE OF HUMAN CADAVERS 
 Research,
development, testing and evaluation (RDT&E), education or training activities involving human cadavers under this award shall not begin until approval is granted in accordance with the Army Policy for Use of Human Cadavers for RDT&E,
Education, or Training, 20 April 2012 

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 (https://mrmc.amedd.army.mil/index.cfm?pageid=research_protections.overview). The USAMRMC Office of
Research Protections (ORP) is the Action Office (usarmy.detrick.medcom-usamrmc.other.hrpo@mail.mil) for this policy. Written approvals to begin the activity will be issued under separate notification to the recipient. Noncompliance with these
terms and conditions may result in withholding of funds and/or the termination of the award. 
 RESEARCH INVOLVING RECOMBINANT DNA MOLECULES 

The recipient assures that all work involving the use of recombinant DNA will be in compliance with guidance provided at http://www4.od.nih.gov/oba.

 NATIONAL POLICY REQUIREMENTS: 

NONDISCRIMINATION 
 By accepting funds
under this award, the recipient assures that it will comply with applicable provisions of the following national policies prohibiting discrimination: 

a. On the basis of race, color, or national origin, in Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d, et seq.), as implemented by
DOD regulations at 32 CFR Part 195. 
 b. On the basis of sex or blindness, in Title IX of the Education Amendments of 1972 (20 U.S.C. 1681,
et seq.), as implemented by DOD regulations at 32 CFR Part 196. 
 c. On the basis of age, in the Age Discrimination Act of 1975 (42 U.S.C.
6101, et seq.) as implemented by Department of Health and Human Services regulations at 45 CFR Part 90. 
 d. On the basis of handicap, in
Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. 794), as implemented by Department of Justice regulations at 28 CFR Part 41 and DOD regulations at 32 CFR Part 56, and the Architectural Barriers Act of 1968 (42 U.S.C. 4151, et seq.).

 DEBARMENT AND SUSPENSION 
 The
recipient assures that it will comply with the requirements regarding debarment and suspension in Subpart C of the OMB guidance in 2 CFR Part 180, as implemented by the DOD in 2 CFR part 1125. The recipient shall communicate the requirement to
comply with Subpart C to persons at the next lower tier with whom the recipient enters into transactions that are “covered transactions” under Subpart B of 2 CFR Part 180 and the DOD implementation in 2 CFR Part 1125. 

ENVIRONMENTAL STANDARDS 
 By accepting
funds under this award, the recipient assures that it will: 
 Comply with applicable provisions of the Clean Air Act (42 U.S.C. 7401, et seq.) and Clean
Water Act (33 U.S.C. 1251, et.seq.), as implemented by Executive Order 11738 [3 CFR, 1971-1975 comp., p. 799] and Environmental Protection Agency (EPA) rules at 40 CFR Part 32. In accordance with the EPA rules, the recipient further agrees that it
will: 
 Not use any facility on the EPA’s List of Violating Facilities in performing any award that is nonexempt under 40 CFR 15.5
(awards of less than $100,000, and certain other awards, exempt from the EPA regulations), as long as the facility remains on the list. 

Notify the awarding agency if it intends to use a facility in performing this award that is on the List of Violating Facilities or that the
recipient knows has been recommended to be placed on the List of Violating Facilities. 

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 Identify to the awarding agency any impact this award may have on: 

The quality of the human environment, and provide help the agency may need to comply with the National Environmental Policy Act (NEPA, at 42
U.S.C. 4321, et seq.) and to prepare Environmental Impact Statements or other required environmental documentation. In such cases, the recipient agrees to take no action that will have an adverse environmental impact (e.g., physical disturbance of a
site such as breaking of ground) until the agency provides written notification of compliance with the environmental impact analysis process. 

Coastal barriers, and provide help the agency may need to comply with the Coastal Barriers Resource Act (16 U.S.C. 3501, et seq.), concerning
preservation of barrier resources. 
 Any existing or proposed component of the National Wild and Scenic Rivers system, and provide help the
agency may need to comply with the Wild and Scenic Rivers Act of 1968 (16 U.S.C. 1271, et seq.). 
 DRUG FREE WORKPLACE 

By accepting funds under this award, the recipient assures that it will comply with the “Government -Wide Drug-Free Workplace (Grants)” requirements
specified by DoDGAR Part 26, Subpart B (or Subpart C, if the recipient is an individual) of 32 CFR Part 26 (2004), which implements sec.5151-5160 of Drug-Free Workplace Act of 1988 (41 U.S.C. 701,et seq.). 

OFFICIALS NOT TO BENEFIT 
 No member of or
delegate to Congress, or resident commissioner, shall be admitted to any share or part of this award, or to any benefit arising from it, in accordance with 41 U.S.C. 22. 

PREFERENCE FOR U.S. FLAG AIR CARRIERS 

Travel supported by U.S. Government funds under this award shall use U.S.-flag air carriers (air carriers holding certificates under 49 U.S.C. 41102) for
international air transportation of people and property to the extent that such service is available, in accordance with the International Air Transportation Fair Competitive Practices Act of 1974 (49 U.S.C. 40118) and the interpretative guidelines
issued by the Comptroller General of the United States in the March 31, 1981, amendment to Comptroller General Decision B138942. 

CARGO PREFERENCE 
 The recipient assures
that it will comply with the Cargo Preference Act of 1954 (46 U.S.C. 1241), as implemented by Department of Transportation regulations at 46 CFR 381.7, which require that at least 50 percent of equipment, materials or commodities procured or
otherwise obtained with U.S. Government funds under this award, and which may be transported by ocean vessel, shall be transported on privately owned U.S.-flag commercial vessels, if available. 

RADIOACTIVE MATERIALS 
 The recipient
assures that it will comply with Title 10 CFR 21. This regulation established procedures and requirements for implementation of Section 206 of the Energy Reorganization Act of 1974. 

TRAFFICKING VICTIMS PROTECTION ACT 

Trafficking in persons. 
 a. Provisions applicable
to a recipient that is a private entity. 

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 1. You as the recipient, your employees, subrecipients under this award, and
subrecipients’ employees may not— 
 i. Engage in severe forms of trafficking in persons during the period of time that the award
is in effect; 
 ii. Procure a commercial sex act during the period of time that award is in effect; or 

iii. Use forced labor in the performance of the award or subawards under the award. 

2. We as the Federal awarding agency may unilaterally terminate this award, without penalty, if you or a subrecipient that is a private
entity— 
 i. Is determined to have violated a prohibition in paragraph a.1 of this award term; or 

ii. Has an employee who is determined by the agency official authorized to terminate the award to have violated a prohibition in paragraph a.1
of this award term through conduct that is either— 
 A. Associated with performance under this award; or 

B. Imputed to you or the subrecipient using the standards and due process for imputing the conduct of an individual to an organization that
are provided in 2 CFR 180, “OMB Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement),” as implemented by our agency at 2 CFR part 1125. 

b. Provision applicable to a recipient other than a private entity. We as the Federal awarding agency may unilaterally terminate this award,
without penalty, if a subrecipient that is a private entity— 
 1. Is determined to have violated an applicable prohibition in paragraph
a.l of this award term; or 
 2. Has an employee who is determined by the agency official authorized to terminate the award to have violated
an applicable prohibition in paragraph a.1 of this award term through conduct that is either— 
 i. Associated with performance under
this award; 
 ii. Imputed to the subrecipient using the standards and due process for imputing the conduct of an individual to an
organization that are provided in 2 CFR part 180, “OMB Guidelines to Agencies on Governmentwide Debarment and Suspension (Nonprocurement),” as implemented by our agency at 2 CFR part 1125. 

c. Provision applicable to any recipient. 

1. You must inform us immediately of any information you receive from any source alleging a violation of a prohibition in paragraph a.1 of this
award term. 
 2. Our right to terminate unilaterally that is described in paragraph a.2. or b. of this section: 

i. Implements section 106(g) of the Trafficking Victims Protection Act of 2000 (TVPA), as amended (22 U.S.C. 7104(g)), and 

ii. Is in addition to all other remedies for noncompliance that are available to us under this award. 

3. You must include the requirements of paragraph a.l of this award term in any subaward you make to a private entity. 

d. Definitions. For the purpose of this award term: 

1. “Employee” means either: 

i. An individual employed by you or a subrecipient who is engaged in the performance of the project or program under this award; or 

ii. Another person engaged in the performance of the project or program under this award and not compensated by you including, but not limited
to, a volunteer or individual whose services are contributed by a third party as an in-kind contribution toward cost sharing or matching requirements. 

2. “Forced labor” means labor obtained by any of the following methods: the recruitment, harboring, transportation, provision, or
obtaining of a person for labor or services, through the use of force, fraud, or coercion for the purpose of subjection to involuntary servitude, peonage, debt bondage, or slavery. 

3. “Private entity” means: 

i. Any entity other than a State, local government, Indian tribe, or foreign public entity, as those terms are defined in 2 CFR 175.25. 

ii. Includes: 
 A. A nonprofit
organization, including any nonprofit institution of higher education, hospital, or tribal organization other than one included in the definition of Indian tribe at 2 CFR 175.25(b). 

B. A for-profit organization. 

4. “Severe forms of trafficking in persons,” “commercial sex act,” and “coercion” have the meanings given at
section 103 of the TVPA, as amended (22 U.S.C. 7102). 

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 REQUIREMENTS FOR FEDERAL FUNDING ACCOUNTABILITY AND TRANSPARENCY ACT IMPLEMENTATION

 Reference 2 CFR part 170, Appendix A to Part 170. 
 I.
Reporting Subawards and Executive Compensation 
 A. Reporting of first-tier subawards. 

1. Applicability. Unless you are exempt as provided in paragraph D. of this award term, you must report each action that obligates
$25,000 or more in Federal funds that does not include Recovery funds (as defined in section 1512(a)(2) of the American Recovery and Reinvestment Act of 2009, Pub. L. 111-5) for a subaward to an entity (see definitions in paragraph e. of this award
term). 
 2. Where and when to report. 

i. You must report each obligating action described in paragraph a.1. of this award term to http://www.fsrs.gov. 

ii. For subaward information, report no later than the end of the month following the month in which the obligation was made. (For example, if
the obligation was made on November 7, 2010, the obligation must be reported by no later than December 31, 2010.) 
 3. What to
report. You must report the information about each obligating action that the submission instructions posted at http://www.fsrs.gov specify. 

B. Reporting Total Compensation of Recipient Executives. 

1. Applicability and what to report. You must report total compensation for each of your five most highly compensated executives for
the preceding completed fiscal year, if— 
 i. the total Federal funding authorized to date under this award is $25,000 or more; 

ii. in the preceding fiscal year, you received— 

(A) 80 percent or more of your annual gross revenues from Federal procurement contracts (and subcontracts) and Federal financial assistance
subject to the Transparency Act, as defined at 2 CFR 170.320 (and subawards); and 
 (B) $25,000,000 or more in annual gross revenues from
Federal procurement contracts (and subcontracts) and Federal financial assistance subject to the Transparency Act, as defined at 2 CFR 170.320 (and subawards); and 

iii. The public does not have access to information about the compensation of the executives through periodic reports filed under section
13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m(a), 78o(d)) or section 6104 of the Internal Revenue Code of 1986. (To determine if the public has access to the compensation information, see the U.S. Security and Exchange
Commission total compensation filings at http://www.sec.gov/answers/execomp.htm.) 
 2. Where and when to report. You must
report executive total compensation described in paragraph b.1. of this award term: 
 i. As part of your registration profile at
http://www.ccr.gov. 
 ii. By the end of the month following the month in which this award is made, and annually thereafter. 

C. Reporting of Total Compensation of Subrecipient Executives. 

1. Applicability and what to report. Unless you are exempt as provided in paragraph d. of this award term, for each first-tier
subrecipient under this award, you shall report the names and total compensation of each of the subrecipient’s five most highly compensated executives for the subrecipient’s preceding completed fiscal year, if— 

i. in the subrecipient’s preceding fiscal year, the subrecipient received— 

(A) 80 percent or more of its annual gross revenues from Federal procurement contracts (and subcontracts) and Federal financial assistance
subject to the Transparency Act, as defined at 2 CFR 170.320 (and subawards); and 
 (B) $25,000,000 or more in annual gross revenues from
Federal procurement contracts (and subcontracts), and Federal financial assistance subject to the Transparency Act (and subawards); and 

ii. The public does not have access to information about the compensation of the executives through periodic reports filed under section 13(a)
or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C. 78m(a), 78o(d)) or section 6104 of the Internal Revenue Code of 1986. (To determine if the public has access to the compensation information, see the U.S. Security and Exchange Commission
total compensation filings at http://www.sec.gov/answers/execomp.htm.) 

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 2. Where and when to report. You must report subrecipient executive total
compensation described in paragraph c.l. of this award term: 
 i. To the recipient. 

ii. By the end of the month following the month during which you make the subaward. For example, if a subaward is obligated on any date during
the month of October of a given year (i.e., between October 1 and 31), you must report any required compensation information of the subrecipient by November 30 of that year. 

D. Exemptions. If, in the previous tax year, you had gross income, from all sources, under $300,000, you are exempt from the
requirements to report: 
 i. Subawards, and 

ii. The total compensation of the five most highly compensated executives of any subrecipient. 

E. Definitions. For purposes of this award term: 

1. Entity means all of the following, as defined in 2 CFR part 25: 

i. A Governmental organization, which is a State, local government, or Indian tribe; 

ii. A foreign public entity; 

iii. A domestic or foreign nonprofit organization; 

iv. A domestic or foreign for-profit organization; 

v. A Federal agency, but only as a subrecipient under an award or subaward to a non-Federal entity. 

2. Executive means officers, managing partners, or any other employees in management positions. 

3. Subaward: 
 i. This
term means a legal instrument to provide support for the performance of any portion of the substantive project or program for which you received this award and that you as the recipient award to an eligible subrecipient. 

ii. The term does not include your procurement of property and services needed to carry out the project or program (for further explanation,
see Sec. — .210 of the attachment to OMB Circular A-133, “Audits of States, Local Governments, and Non-Profit Organizations”). 

iii. A subaward may be provided through any legal agreement, including an agreement that you or a subrecipient considers a contract. 

4. Subrecipient means an entity that: 

i. Receives a subaward from you (the recipient) under this award; and 

ii. Is accountable to you for the use of the Federal funds provided by the subaward. 

5. Total compensation means the cash and noncash dollar value earned by the executive during the recipient’s or
subrecipient’s preceding fiscal year and includes the following (for more information see 17 CFR 229.402(c)(2)): 
 i. Salary and
bonus. 
 ii. Awards of stock, stock options, and stock appreciation rights. Use the dollar amount recognized for financial statement
reporting purposes with respect to the fiscal year in accordance with the Statement of Financial Accounting Standards No. 123 (Revised 2004) (FAS 123R), Shared Based Payments. 

iii. Earnings for services under non-equity incentive plans. This does not include group life, health, hospitalization or medical
reimbursement plans that do not discriminate in favor of executives, and are available generally to all salaried employees. 
 iv. Change in
pension value. This is the change in present value of defined benefit and actuarial pension plans. 
 v. Above-market earnings on deferred
compensation which is not tax- qualified. 
 vi. Other compensation, if the aggregate value of all such other compensation (e.g., severance,
termination payments, value of life insurance paid on behalf of the employee, perquisites or property) for the executive exceeds $10,000. 

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 FINANCIAL ASSISTANCE USE OF UNIVERSAL IDENTIFIER AND CENTRAL CONTRACTOR REGISTRATION

 Reference 2 CFR part 25, Appendix A to Part 25. 
  

	I.	Central Contractor Registration and Universal Identifier Requirements 

 A. Requirement for
Central Contractor Registration (CCR). Unless you are exempted from this requirement under 2 CFR 25.110, you as the recipient must maintain the currency of your information in the CCR until you submit the final financial report required under
this award or receive the final payment, whichever is later. This requires that you review and update the information at least annually after the initial registration, and more frequently if required by changes in your information or another award
term. 
 B. Requirement for Data Universal Numbering System (DUNS) Numbers. If you are authorized to make subawards under this award,
you: 
 1. Must notify potential subrecipients that no entity (see definition in paragraph C of this award term) may receive a subaward from
you unless the entity has provided its DUNS number to you. 
 2. May not make a subaward to an entity unless the entity has provided its DUNS
number to you. 
 C. Definitions. For purposes of this award term: 

1. Central Contractor Registration (CCR) means the Federal repository into which an entity must provide information required for the
conduct of business as a recipient. Additional information about registration procedures may be found at the CCR Internet site (currently at http://www.ccr.gov). 

2. Data Universal Numbering System (DUNS) number means the nine-digit number established and assigned by Dun and Bradstreet, Inc.
(D&B) to uniquely identify business entities. A DUNS number may be obtained from D&B by telephone (currently 866-705-5711) or the Internet (currently at http://fedgov.dnb.com/webform). 

3. Entity, as it is used in this award term, means all of the following, as defined at 2 CFR part 25, subpart C: 

a. A Governmental organization, which is a State, local government, or Indian Tribe; 

b. A foreign public entity; 
 c.
A domestic or foreign nonprofit organization; 
 d. A domestic or foreign for-profit organization; and 

e. A Federal agency, but only as a subrecipient under an award or subaward to a non-Federal entity. 

4. Subaward: 
 a. This
term means a legal instrument to provide support for the performance of any portion of the substantive project or program for which you received this award and that you as the recipient award to an eligible subrecipient. 

b. The term does not include your procurement of property and services needed to carry out the project or program (for further explanation,
see Sec. ——.210 of the attachment to OMB Circular A-133, “Audits of States, Local Governments, and Non-Profit Organizations’’). 

c. A subaward may be provided through any legal agreement, including an agreement that you consider a contract. 

5. Subrecipient means an entity that: 

a. Receives a subaward from you under this award; and 

b. Is accountable to you for the use of the Federal funds provided by the subaward.

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