Document:

Helius Medical Technologies, Inc.: Exhibit 15-C-0096-QASP - Filed by newsfilecorp.com

QUALITY ASSURANCE SURVEILLANCE PLAN 

For the Development and U.S. Food and Drug Administration (FDA)
Clearance of the
Portable Neuromodulation Stimulator (PoNSTM)
Device 
Contract Number: W81XWH-15-C-0096 
Contractor Name:
NeuroHabilitation Corporation

1. PURPOSE. 

This Quality Assurance Surveillance Plan (QASP) provides a
systematic method to evaluate performance for the stated contract. This QASP
explains the following: 

	 	• 	What will be monitored? 
	 	• 	How monitoring will take place? 
	 	• 	Who will conduct the monitoring? 
	 	• 	How monitoring efforts and results will be
      documented? 

This QASP does not detail how the contractor accomplishes the
work. Rather, the QASP is created with the premise that the contractor is
responsible for management and quality control actions to meet the terms of the
contract. It is the Government’s responsibility to be objective, fair, and
consistent in evaluating performance. In addition, the QASP should recognize
that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review
and revise it on a regular basis. However, the Government shall coordinate
changes with the contractor. Updates shall ensure that the QASP remains a valid,
useful, and enforceable document. Copies of the original QASP and revisions
shall be provided to the contractor and Government officials implementing
surveillance activities. 

2. GOVERNMENT ROLES AND RESPONSIBILITIES. 

The following personnel shall oversee and coordinate
surveillance activities.

a. Contracting Officer (KO) - The KO shall ensure performance
of all necessary actions for effective contracting, ensure compliance with the
contract terms, and shall safeguard the interests of the United States in the
contractual relationship. The KO shall also assure that the contractor receives
impartial, fair, and equitable treatment under this contract. The KO is
ultimately responsible for the final determination of the adequacy of the
contractor’s performance. 

Assigned KO:
Organization or Agency: US Army Medical
Research Acquisition Activity 
Telephone: Phone: 

Email:

b. Contracting Officer’s Representative (COR) – The COR is
located at the U.S. Army Medical Materiel Agency (USAMMA) Office at. The COR
will be responsible for technical administration of this contract, and shall
assure proper Government surveillance of the contractor’s performance with the
assistance of two (2) Contracting Officer’s Technical Representatives (COTRs).
The COR shall keep a quality assurance file. At the conclusion of the contract
or when requested by the KO, the COR shall provide documentation to the KO. A
COR is not empowered to make any contractual commitments or to authorize any
contractual changes on the Government’s behalf. The contractor shall refer any
changes they deem may affect contract price, terms, or conditions to the KO for
action. 

Assigned COR:
Title: Assistant Project Manager, USAMMA

Telephone:
Email:

3. CONTRACTOR REPRESENTATIVES: 

The following employees of the contractor serve as the
contractor’s Program Managers for this contract.

Assigned Program Manager: Philippe Deschamps 
Title:
President, CEO, Helius Medical Technologies 
Telephone:
Email:

4. PERFORMANCE STANDARDS. 

Performance standards define desired services. The Government
performs surveillance to determine if the contractor exceeds, meets or does not
meet these standards.

The Performance Requirements Summary Matrix, shown in Table 1
below and contained in the Performance Work Statement (PWS) for this contract in
Section C, includes performance standards. The Government shall use these
standards to determine contractor performance and shall compare contractor
performance to the Acceptable Quality Level (AQL).

Table 1. Performance Requirements 

	Number 	Deliverable 	Performance Standards 	Acceptable Quality Level 	Methods
      Used & Frequency 	Paragraph Number 	Compliance Level Data 
	1 	Reports (CDRL A011 & A012)
    	Contractor’s plans, updates, and reports
      that describe progress made within the period and inform the Government of
      existing or potential issues and problem areas and risk mitigation plans
    	100% of project issues
      identified 	COR reviews reports as provided and any
      subsequent modifications 	3.1.1, 3.1.2,
3.1.3, 3.1.4,
      
3.2.1, 3.3.1, 
3.3.3, 3.5.1,
3.5.2, 3.5.3, 
3.5.4, and
      
3.5.5 	Reports received as specified in PWS
  

	Number 	Deliverable 	Performance Standards
	Acceptable Quality
      Level 	Methods Used & Frequency
      	Paragraph Number
      	Compliance Level Data
  
	2 	IRB Approved Clinical Protocols (CDRL A003)
    	Contractor’s Clinical Study Protocol and informed consent
      form including Statistical Analysis Plan, Clinical Monitoring Plan, Data
      Management Plan, Proposed Clinical Data Management System, sample Case
      Report Form, End User Guidelines (training and technical support), and
      Recruitment and Retention Plan for each site. 	Suitable for submission to FDA in support of device
      clearance 	COR reviews documents as provided 	3.1.3 	Within 3 months of contract award 
	3 	IRB Approvals (CDRL A004) 	Documentation of appropriate IRB approvals from each study
      site, institution, and the Army, as required 	Suitable for submission to FDA in support of device
      clearance 	COR reviews documents as provided 	3.1.4 	Within 3 months of contract award and prior to the start
      of the clinical study 
	4 	Representati ve Test Articles (CDRL A005) 	Final development and manufacturing of representative test
      articles for use in the clinical trial; report completion and delivery to
      clinical test sites; contingency plan 	120 (and/or a proportionate amount consistent with FDA
      guidance) representative test articles (PoNSTM, version 4.0) in
      support of the clinical trial 	COR reviews as provided 	3.1.5 	Prior to start of clinical trial

	Number 	Deliverable 	Performance Standards
	Acceptable
      Quality Level 	Methods Used &
      Frequency 	Paragraph
      Number 	Compliance Level
      Data 
	5 	Conduct Clinical Study (CDRL A006) 	Conduct clinical study in accordance with study protocol
      and governing regulations 	Study conducted to meet FDA submission and Army
      requirements at a minimum of 3 study sites and 120 subjects (and/or a
      proportionate amount consistent with FDA guidance) 	COR reviews documents as provided (monthly/quart
      erly/annual reports, IMF update, etc.) 	3.2.1 	Study is completed within period of performance 
	6 	Interim Data Analysis (CDRL A007) 	Conduct an interim data analysis and provide Interim
      Clinical Study Report and Mitigation Plan 	Verification study is adequately powered and mitigation
      plan for issues identified during analysis 	COR reviews documents as provided 	3.2.2 	Within 30 days after completion of 60 subjects (and/or a
      proportionat e amount consistent with FDA guidance) 
	7 	FDA de novo/510(k) Submission
      with Supporting Documentati on and Pre- Clinical Study Results Summary
      (CDRL A008, A009 & A013) 	Complete, final report all studies, papers, pre- clinical
      studies, and other documentation that will support the de
      novo/510(k) submission packet 	100% complete to support all claims and data used for the
      submission to FDA in support of device clearance 	COR reviews documents as provided 	3.3.1, 3.3.2 & 3.5.4 	Concurrently with FDA submission 
	8 	Technical Data Package (CDRL A010) 	Provide copies of TDP content, which includes the Design
      History File, Device Master Record, and Device History File. 	All necessary documentation and data required to continue
      the development or production of the product 	COR reviews documents as provided 	3.3.4 	Within seven (7) business days of the Government ’s
      request and/or at contract expiration. 

	Number 	Deliverable 	Performance Standards
	Acceptable Quality
      Level 	Methods Used &
      Frequency 	Paragraph Number 	Compliance Level Data
  
	9 	Delivery of 2 FDA cleared
      PoNSTM Devices 	Delivery of 2 FDA cleared PoNSTM
      devices with the indication as an aid to therapy for chronic balance
      deficits resulting from mild to moderate TBI and all accessories, product
      inserts, and supporting manuals/literature (e.g. including user,
      technical, and maintenance manuals) as applicable. 	100% complete FDA cleared medical devices 	COR reviews as provided 	3.4.1 	Within 10 business days of FDA clearance 
	10 	For Contract Requiring Performance or
      Delivery in a Foreign Country. 	IAW PWS Section 4.1.3.2. 	100% 	COR Verification 	2.5 	Within 60 calendar days of foreign travel.

5. METHODS OF QA SURVEILLANCE.

Various methods exist to monitor performance. The COR shall use
the surveillance methods listed below in the administration of this QASP.

	 	• 	Feedback from Oversight Board 
	 	• 	Feedback from Government Users 
	 	• 	Feedback from Property Book Officers 
	 	• 	Direct Observation 
	 	• 	100% Inspection 
	 	• 	Review of Quarterly Reports (various) 
	 	• 	Review of Monthly Reports (various)
  

Regardless of the surveillance method, the COR shall always
contact the contractor's task manager or on-site representative when a defect is
identified and inform the manager of the specifics of the problem. The COR shall
be responsible for monitoring the contractor’s performance in meeting a specific
performance standard/AQL. 

	 	• 	DIRECT OBSERVATION. (Can be performed
      periodically or through 100% surveillance.) 

		
      • 
	
      MANAGEMENT INFORMATION SYSTEMS (MIS). (Evaluates outputs
      through the use of management information reports. Best used for general
      surveillance and may need to be supplemented by periodic inspections.)
    

	
       
	
       
	
       

		
      • 
	
      PERIODIC INSPECTION. Uses a comprehensive evaluation of
      selected outputs. Inspections may be scheduled as required.
  

	 	o 	Analysis of contractor's progress reports.
      (Evaluate cost, schedule, etc.) 
	 	o 	Performance reporting. 

Surveillance results may be used as the basis for actions (to
include payment deductions) against the contractor. In such cases, the
Inspection of Services clause and the Inspection of Supplies clause in the
Contract becomes the basis for the KO’s actions. 

6. RATINGS. 

Metrics and methods are designed to determine if performance
exceeds, meets, or does not meet a given standard and acceptable quality level.
A rating scale shall be used to determine a positive, neutral, or negative
outcome. The following ratings shall be used: 

Example 1: 

	EXCEPTIONAL: 	Performance significantly exceeds contract
      requirements to the Government’s benefit. 
	SATISFACTORY: 	Performance meets contractual requirements. 
	UNSATISFACTORY: 	Performance does not meet contractual
      requirements. 

7. DOCUMENTING PERFORMANCE. 

a. ACCEPTABLE PERFORMANCE. 

The Government shall document positive performance. A report
template is attached. Any report may become a part of the supporting
documentation for fixed fee payments, award fee payments, or other actions.

b. UNACCEPTABLE PERFORMANCE. 

When unacceptable performance occurs, the COR shall inform the
contractor. This will normally be in writing unless circumstances necessitate
verbal communication. In any case the COR shall document the discussion and
place it in the COR file.

When the COR determines formal written communication is
required, the COR shall prepare a Contract Discrepancy Report (CDR), and present
it to the contractor's task manager or on-site representative. A CDR template is
attached to this QASP.

The contractor shall acknowledge receipt of the CDR in writing.
The CDR will specify if the contractor is required to prepare a corrective
action plan to document how the contractor shall correct the unacceptable
performance and avoid a recurrence. The CDR will also state how long after
receipt the contractor has to present this corrective action plan to the COR.
The Government shall review the contractor's corrective action plan to determine
acceptability.

Any CDRs may become a part of the supporting documentation for
contract payment deductions, fixed fee deductions, award fee nonpayment, or
other actions deemed necessary by the KO.

8. FREQUENCY OF MEASUREMENT. 

a. Frequency of Measurement. 

During contract/order performance, the COR shall take periodic
measurements, quarterly as specified in the AQL column of the Performance
Standards Summary Matrix, and shall analyze whether the negotiated frequency of
measurement is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings. 

The COR shall meet with the contractor quarterly to assess
performance and shall provide a written assessment.

PERFORMANCE
REPORT 

1. CONTRACT NUMBER: TBD 

2. Prepared by: COR NAME ENTERED AT TIME OF AWARD

3. Date and time of observation: 

4. Observation:

<Examples of items to include in a report are: 
- Method
of surveillance. 
- How frequently you conducted surveillance. 
-
Surveillance results. 
- Number of observations.> 

Prepared by: COR 

	 	 	 
	Signature – Contracting Officer’s Representative 	   Date

CONTRACT
DISCREPANCY REPORT
(CDR) 

1. Contract Number: TBD 

2. TO: (Contractor Task Manager or on-site
representative) Philippe Deschamps 

3. FROM: TBD 

4. Date and time observed discrepancy:

5. DISCREPANCY OR PROBLEM:

<Describe in detail. Identify any attachments.>

6. Corrective action plan:

A written corrective action plan < is / is not >
required. 

< If a written corrective action plan is required include
the following. > The written Corrective Action Plan will be provided to the
undersigned not later than < # days after receipt of this CDR. >

Prepared by: COR 

	 	 
	Signature – Contracting Officer’s Representative 	Date 

Received by: 

	 	 
	Signature - Contractor Task Manager or on-site
      representative 	Date 

	
      The COR may initiate a CDR at any time, including
      whenever the number of monthly recorded defects for a performance standard
      exceeds the allowable number of defects; anytime unacceptable performance
      is determined critical in nature and requires formal corrective action;
      and whenever an unfavorable trend is detected in contractor performance.
      

Page 2 of 41 

Section A - Solicitation/Contract Form 

ADDITIONAL INFORMATION 
ADDITIONAL
INFORMATION

PROJECT TITLE: Development and U.S. Food and Drug
Administration (FDA) Clearance of the Portable Neuromodulation Stimulator (PoNS)
Device. 

The requirement is an R&D contract. 

GOVERNMENT POINTS OF CONTACT 

The Contract Specialist for this contract is 

The Contracting Officer for this contract is 

The Contracting Officer’s Representative for this contract is

Page 3 of 41 

Section B - Supplies or Services and Prices 

	ITEM NO 	SUPPLIES/SERVICES 	QUANTITY 	UNIT 	UNIT PRICE 	AMOUNT 
	0001 	  	1 	Job 	  	$217,975.21 
	  	Labor - Sponsor 	  
	  	COST 	  
	  	Labor - Sponsor, Development and FDA
      Clearance of the PoNS device. 	  
	  	FOB: Destination 	  
	  	PURCHASE REQUEST NUMBER:
      0010553630-0003 	  
	  	  	  	  	  	  
	  	  	  	  	ESTIMATED COST 	$217,975.21NTE 
	  	ACRN AA 	$217,975.21 
	  	CIN: GFEBS001055363000001 	  

	ITEM NO 	SUPPLIES/SERVICES 	QUANTITY 	UNIT 	UNIT PRICE 	AMOUNT 
	0002 	  	1 	Job 	  	$2,763,289.24 
	  	ODC - Subcontractor Expenses 	  
	  	COST 	  
	  	Other Direct Costs (ODCs) -
      Subcontractor expenses to include; Clinical 	  
	  	Research Organization, Regulatory,
      Contract Manufacturing, and Consultant. 	  
	  	FOB: Destination 	  
	  	PURCHASE REQUEST NUMBER:
      0010553630-0002 	  
	  	  	  	  	  	  
	  	  	  	  	ESTIMATED COST 	$2,763,289.24NTE 
	  	ACRN AA 	$2,763,289.24 
	  	CIN: GFEBS001055363000002 	  

	ITEM NO 	SUPPLIES/SERVICES 	QUANTITY 	UNIT 	UNIT PRICE 	AMOUNT 
	0003 	  	1 	Job 	  	$14,979.55 
	  	ODC - Travel 	  
	  	COST 	  
	  	Other Direct Costs (ODCs) - Travel
	  
	  	FOB: Destination 	  
	  	PURCHASE REQUEST NUMBER:
      0010553630-0002 	  
	  	  	  	  	  	  
	  	  	  	  	ESTIMATED COST 	$14,979.55NTE 
	  	ACRN AA 	$14,979.55 
	  	CIN: GFEBS001055363000003 	  

Page 4 of 41 

Page 5 of 41 

Section C - Descriptions and Specifications 

PERFORMANCE WORK STATEMENT 

PERFORMANCE WORK STATEMENT (PWS) 

Development and U.S. Food and Drug Administration (FDA)
Clearance of the Portable Neuromodulation 
Stimulator (PoNSTM)
Device

1. Introduction: 

The U.S. Amy Medical Materiel Agency (USAMMA) and its parent
organization the U.S. Army Medical Research and Materiel Command (USAMRMC) are
located at Fort Detrick, in Frederick, Maryland. USAMMA serves as the strategic
level, medical logistics generating force, and medical lifecycle management
command in support of Army Medicine, the Army Campaign Plan, Military Health
System, and Combatant Commands. The agency provides optimal medical acquisition
and logistics support and solutions across the full spectrum of military health
care missions worldwide. USAMMA has operational oversight of medical materiel
acquisition programs and serves as the Army Medical Department’s (AMEDD’s)
command for fielding new medical materiel for the Army’s operational forces.

1.1. Background and Purpose: 

The U.S. Army is supporting an effort to develop
NeuroHabilitation Corporation’s (NHC) Portable Neuromodulation Stimulator
(PoNSTM) as an aid to therapy for chronic balance deficits resulting from a mild
to moderate traumatic brain injury (TBI). On 1 February 2013, USAMMA, the U.S.
Army Medical Materiel Development Activity (USAMMDA), and NHC established a
collaborative relationship, via a Cooperative Research and Development Agreement
(CRADA) under 15 USC §3710a, to develop an investigational medical device that
employs non-invasive brain stimulation. The PoNSTM device, developed partially
under the CRADA, works by applying principles of neuroplasticity that enables
the brain to process information in new ways for rehabilitation after injury.
The goal of this contract is to take the PoNSTM from an investigational medical
device to an FDA-cleared device, obtaining clearance for the following
indication: as an aid to therapy for chronic balance deficits resulting from
mild to moderate traumatic brain injury (TBI). 

The Contractor will be the regulatory sponsor and overall
project coordinator for the PoNSTM version 4.0 device. The critical components of
this PWS to obtain FDA regulatory clearance include the following steps: (1)
write the clinical study protocols, (2) execute the clinical studies, (3) manage
the clinical research sites, (4) submit the de novo/510(k) or other
application to FDA, and (5) gain FDA clearance of the PoNSTM version
4.0 device for a mild-to-moderate TBI indication. 

1.2. Scope:

This is a Research and Development (R&D) contract. The
objective of this contract is to execute the clinical studies and regulatory
responsibilities necessary to obtain FDA clearance for the PoNSTM 4.0 device and
provide two FDA-cleared devices to the DoD (specifically USAMMA). 

The Contractor shall complete the tasks noted in paragraph 3.1
to support the de novo/510(k) clearance application in accordance with
(IAW) all noted applicable State, Federal, DoD, and U.S. Army regulations. The
Contractor shall oversee and execute the clinical study. The Contractor shall
support and perform services with DoD civilians, military and other Contractor
personnel. The Contractor shall travel to Fort Detrick, Maryland at the
Government’s request for an annual In Progress Review (IPR). 

1.2.1. The Contractor shall perform the services set
forth in this PWS, pursuant to the award of a R&D contract. The Contractor
shall furnish all management, personnel, services, and other items necessary to
successfully deliver the required services. The Contractor shall possess
knowledge and skills in PoNSTM use/training/therapy, and regulatory
requirements necessary to obtain 510(k) clearance.

Page 6 of 41 

1.2.2. This contract supports the Project Management
Office, Medical Devices, and USAMMA. The Government shall not exercise any
supervision or control over the Contractor’s employees performing services under
this contract. Contractor employees shall be accountable solely to the
Contractor who, in turn is responsible to the Government.

1.2.3. The Contractor shall provide all personnel,
equipment, supplies, facilities, transportation, tools, materials, supervision,
and other items necessary to achieve the tasks as defined in this PWS.

1.2.4. Assumptions of the Parties: 

1.2.4.1. A de novo/510 (k)
petition shall be required for FDA to clear the PoNSTM 4.0 device.

1.2.4.2. The clinical trial using PoNSTM
is considered to be of non-significant risk and, therefore, shall not require an
Investigational Device Exemption submission. 

1.2.4.3. QSR-produced PoNSTM 4.0 devices
shall be available in/around April 2015 for use in the study. The devices shall
be provided to the clinical trial sites by the Sponsor/Contractor. 

1.2.4.4. The study shall take
approximately 9-12 months to complete. 

1.3. Period of Performance. The period of performance
shall be for one (1) eighteen (18) month Base Period. The Period of Performance
breakdown reads as follows: 

	Base
      Period 	01
      July 2015 – 31 December 2016 

2. General Requirements:

2.1. Business Relations: 

The Contractor shall successfully integrate and coordinate all
activity needed to execute the requirement. The Contractor shall manage the
timeliness, completeness, and quality of problem identification. The Contractor
shall provide corrective action plans, proposal submittals, timely
identification of issues, and effective management of subcontractors. The
Contractor shall seek to ensure customer satisfaction and professional and
ethical behavior of all Contractor personnel. 

2.2. Contract Administration and Management: 

This PWS provides distinct activities and functions. These
activities are described in the following subsections, which specify
requirements for contract management, contract administration, and personnel
administration. 

2.2.1. Contract Management:

The Contractor shall establish clear organizational lines of
authority and responsibility to ensure effective management of the resources
assigned to the requirement.

2.2.1.1. Management Activities. The
Contractor shall identify a single point of contact as the Project Manager (PM).
The Contractor PM shall ensure that the task is performed efficiently,
accurately, timely, and in compliance with this PWS. The Contractor PM shall
coordinate, as necessary with the Contracting Officer Representative (COR), to
ensure the services are managed consistently with overall contract requirements.
The Contractor PM shall submit all invoices within 30 days from completion of
tasks at the end of each month.

2.2.2. Contract Administration. The Contractor shall
establish processes and assign appropriate resources to effectively administer
this contract. The Contractor shall respond to Government requests for
contractual actions within one (1) day. The Contractor shall have a single point of
contact between the Government and Contractor employee assigned to support the
contract. 

Page 7 of 41 

2.3. Subcontract Management. The Contractor shall: 

2.3.1. Manage any subcontract management necessary to
integrate services to meet the overall requirements of this contract. 

2.3.2. Be responsible and accountable for subcontractor
performance on this requirement.

2.3.3. Manage work distribution to ensure there are no
Organizational Conflict of Interest (OCI) considerations.

2.3.4. Add subcontractors to their team, as needed,
after notification to the KO or COR. The Government may or may not permit
cross-teaming (See paragraph 7.1.12 for definition). 

2.4. Travel. The COR is designated, in writing, as the
Contractor’s travel order approval authority by the contracting officer. Travel
to government facilities or other locations that are requested by the
Government for the annual IPR may be required. Only travel requirements
specifically requested by the Government (including plans, agenda,
itinerary, or dates) shall be pre-approved by the COR and is on a strictly
cost-reimbursable basis. Costs for travel shall be billed IAW the regulatory
implementation of Public Law 99-234 and FAR 31.205 -46 Travel Costs. 

2.5. Anti-terrorism / Operation Security. For Contract
Requiring Performance or Delivery in a Foreign Country. DFARS Clause 252.225
-7043, Antiterrorism/Force Protection for Defense Contractors Outside the
United States. The clause shall be used in solicitations and contracts that
require performance or delivery in a foreign country. This clause applies to
both contingencies and non-contingency support. The key AT requirement is for
nonlocal national contractor personnel to comply with theater clearance
requirements and allows the combatant commander to exercise oversight to ensure
the contractor’s compliance with combatant commander and subordinate task force
commander policies and directives.

3. Specific Tasks and Performance Objectives 

The Contractor shall complete development of the PoNSTM
device from its current state as an investigational device to a FDA
cleared/approved medical device for the following indication: an aid to therapy
for chronic balance deficits resulting from mild to moderate TBI. The Contractor
shall be the FDA regulatory sponsor, in accordance with Section 21, Code of
Federal Regulations. The Contractor shall deliver two complete FDA
cleared/approved devices to the government. The Contractor shall accomplish all
required tasks and services IAW this PWS that include, but are not limited to
the following Specific Tasks and Performance Objectives for the contract. 

3.1. Contract Tasks and Performance Objectives Required
Before Start of Clinical Trial 

3.1.1. Project Management Plan. The Contractor shall
provide a draft Project Management Plan, including an initial Integrated Master
Schedule (IMS) and Risk Management Plan that encompasses the entire scope of the
contract, with the Contractor’s proposal. The final Project Management Plan
shall be submitted within 30 days of contract award. The IMS documents the
critical path (including futility point), major milestones, tasks/activities,
deliverables, duration, lead/lag/slack time and schedule relationships, and is
directly traceable to the PWS. The IMS will contain all major project management
tasks and associated milestones and/or deliverables to assist the Government in
its monitoring of Contractor performance. The IMS shall be updated quarterly to
track progress (CDRL A001 / QASP #1). 

3.1.2. Quality Control Plan (QCP). The Contractor shall
provide a draft QCP with the Contractor’s proposal. The Contractor shall prepare
and implement a final QCP to ensure that all activities of the project are
managed in a sound, reasonable way in conformance to the Government’s
requirements within 30 days of contract award. The Contractor shall ensure that
all deliverables produced are acceptable prior to delivery to the Government.
Under this QCP, the Contractor shall provide for the Government or its designee
to audit the Contractor and/or its Subcontractors for regulatory compliance and quality assurance
purposes. At a minimum, the QCP shall include a self-inspection plan, an
internal staffing plan, and an outline of the procedures that the Contractor
shall use to maintain quality, timeliness, responsiveness and customer
satisfaction. The QCP shall be updated as needed and reviewed at least quarterly
(CDRL A002 / QASP #1). 

Page 8 of 41 

3.1.3. Institutional Review Board Approved Clinical
Protocols. The Contractor shall provide a copy of the IRB-approved clinical
study protocol and informed consent form for each study site within 3 months of
contract award. The Contractor shall also provide the COR supporting
documentation that shall include at minimum a Statistical Analysis Plan,
Clinical Monitoring Plan, Data Management Plan, Proposed Clinical Data
Management System, Sample Case Report Forms, End User Guidelines (Training and
Technical Support), and a Recruitment and Retention Plan for each site (CDRL
A003 / QASP #2).

3.1.4. Institutional Review Board Approvals. The
Contractor shall provide the COR with documentation of appropriate IRB approvals
from each study site, institute, and Army, as required within 3 months of
contract award and prior to the start of the clinical study. The Contractor
shall maintain and update files of all applicable regulatory documentation for
all appropriate IRBs (CDRL A004 / QASP #3). 

3.1.5. Representative Test Articles. The Contractor
shall provide final development and manufacturing of sufficient representative
test articles (PoNSTM version 4.0 device) for use in the clinical
trial for a minimum of 120 subjects (and/or a proportionate amount consistent
with FDA guidance), including a contingency plan for replacement of defective
and/or test articles that may be lost or damaged during the clinical trial. The
devices shall be manufactured in a Title 21 CFR §820 Quality Systems
Regulation (QSR)-compliant manufacturing facility and process that has
successfully completed design verification testing and human factors testing
(CDRL A005 / QASP #4). 

3.2. Contract Tasks and Performance Objectives Required
During Clinical Trial: 

3.2.1. Conduct Clinical Trial. The Contractor shall
conduct a clinical study to evaluate the treatment effect on balance using the
PoNSTM version 4.0 devices at a minimum of three (3) study sites for
a total of 120 subjects (and/or a proportionate amount consistent with FDA
guidance). The Contractor shall conduct the clinical study in accordance with
the study protocol and governing FDA Regulations. The Contractor shall provide a
copy of their agreement with each study site that shall be responsible for
executing the clinical trial in a manner that successfully supports an FDA
submission and provide the COR with monthly status reports (CDRL A011 / QASP
Item #1 and #5). 

3.2.2. Interim Data Analysis. The Contractor shall
conduct interim data analysis after 60 subjects (and/or a proportionate amount
consistent with FDA guidance) to evaluate the observed treatment effect in order
to determine if the study is adequately powered. The Contractor shall provide an
Interim Clinical Study Report that includes the raw data and statistical
analysis on the results within 30 day after completion of the 60 (or
proportionate amount) subject testing , the futility point, and a mitigation
plan for issues identified during the analysis (CDRL A007 / QASP #6). 

3.3. Contract Tasks and Performance Objectives Required
After Conclusion of Clinical Trial: 

3.3.1. Final Clinical Study Report. The Contractor shall
provide a complete Final Clinical Study Report that includes raw data and
statistical analysis 75 days after completion of the study (CDRL 008 / QASP #1).

3.3.2. FDA Submission Packet. The Contractor shall
provide data as deemed necessary by the FDA to support a clinical trial, and a
copy of the de novo/510(k) application submission packet with copies of
all supporting documentation, including but not limited to, the Pre-clinical
Study results summary. This documentation shall be provided concurrent with FDA
submission (CDRL A009 / QASP #7). 

3.3.3. Final Report. The Contractor shall provide a
Final Report that is formatted using best practices and consolidate (summarize)
all data, costs, results, final status on all deliverables, and work activities
performed during the contract period within 30 days after the end of the
contract (CDRL A011 / QASP #1). 

Page 9 of 41 

3.3.4. Technical Data Packet. The Contractor shall
provide the COR with a complete technical data packet (TDP) upon request by the
Government within seven (7) business days. The Contractor shall prepare and
maintain currency of a TDP that includes all necessary documentation and
technical data and reports collected and prepared during the development effort
funded by the Government. The TDP shall include all necessary documentation and
data for the Government, or its designee, to continue the development or
production of the product, including but not limited to the Design History File,
Device Master Record, and Device History File. The Contractor shall assist in
the technical transfer as directed by the Government. The Contractor shall
provide copies of TDP content as requested by Government and at contract
expiration (CDRL A010 / QASP #8). 

3.4. Contract Tasks and Performance Objectives Required
After FDA Clearance/Approval: 

3.4.1. FDA Cleared Devices. The Contractor shall
provide two (2) FDA cleared the PoNSTM devices with an indication as
an aid to therapy for chronic balance deficits resulting from mild to moderate
TBI, and all accessories, product inserts, and supporting manuals/literature
(e.g., including user, technical, and maintenance manuals), as applicable, to
the COR within 10 business days of FDA clearance (QASP #9). Any minor deviation
of the above indication required by FDA guidance, must be approved by the
Government and will be considered in scope of this contract.

3.5. Contract Tasks and Performance Objectives Required
During Duration of Contract: 

3.5.1. Progress, Status, and Management Reports. The
Contractor shall provide annual, quarterly, and monthly Progress, Status, and
Management Reports that describe progress made within the period, status of
milestones and deliverables, cost expenditures against proposed costs (resource
utilization), and inform the Government of existing or potential issues and
problem areas and risk mitigation plans. The Contractor shall periodically
provide an oral or email status report as the task proceeds to support the
integrated product team needs for presentations and other tasks as needed to
support the product effort. The reports shall include an updated IMS that shows
the percent complete of each scheduled task item. Percent complete is defined as
the cumulative amount of work actually performed through the end of the
reporting month expressed as a percentage of the total amount of work to be
performed. Monthly reports shall be provided to the COR the 10th day
of each month, quarterly reports shall be provided the 15th day of
each quarter, and annual reports shall be provided the 15th day after
the end of each year (CDRL A011 / QASP #1). 

3.5.2. Production or Delivery Problem Reports. Any
significant positive or negative deviation to the schedule or scope of a task
shall be explained and documented by the Contractor in its annual, quarterly,
and monthly progress, and Status and Management Report shall be reported to the
Government within 2 weeks of identification as a Production or Delivery Problem
Report (CDRL A011 / QASP #1). 

3.5.3. Annual Program Reviews. The Contractor shall
formally present the prior year’s progress as part of an annual program review
(for example, the IPR). The content of the briefing shall include but not be
limited to the following: completed tasks within the year, highlights of
completed tasks, summary of results from in-process studies, schedule updates,
summary of results from completed studies, risks/issues, and funding execution.
The annual program reviews shall be held at Fort Detrick, MD and may be held in
conjunction with the integrated product team (IPT) meetings with senior
leadership. Additional requests for travel to Fort Detrick, MD may be requested
by the Government as needed (CDRL A011 / QASP #1). 

3.5.4. FDA Communication and Study Reports. The
Contractor shall provide the COR with FDA Communication and Study Reports.
Regulatory documents including informal emails sent to the FDA are sent
concurrently to the Government. Meeting notes shall be sent to the Government if
efforts to attend verbal meetings (such as phone calls or meetings at the FDA)
are not possible. Copies of informal and formal regulatory communications
received from the FDA shall be sent within three (3) business days of receipt.
Copies of Clinical Monitoring Reports should be sent within 30 business days of
receipt (CDRL A013 / QASP #7). 

Page 10 of 41 

3.5.5. Trip Reports. The Contractor shall provide Trip
Reports within five (5) business days for trips that have been requested by the
Government. The report should describe the purpose, results of the trip, and
actual costs (CDRL A001 / QASP #1). 

3.5.6. The Contractor shall assist in Kick-Off,
coordination, progress update, and informational meetings. 

3.5.7. The Contractor shall provide guidance and consult
with Principal Investigator, senior staff, and clinical personnel during formal
training and to review data from pilot trial. The Contractor shall provide
recommendations for modifications to interventions when used with the
PoNSTM device, measurement tools and procedures.

3.5.8. The Contractor shall consult on data
interpretation and collaborate on publications and presentations. 

4. Deliverables:

The Contractor shall provide deliverables as described in the
below chart.

Deliverable Table 

	
      Item 
	PWS Ref 
	Title 
	Distribution 
	
      E 
	Initial & Subsequent 

	
      1 
	
      2.2.1.1. 
	
      Program Manager Point of Contact 
	
      COR 
	
      1 
	
      Upon award of contract 

	
      2 
	
      3.1.1. 
	
      Final Project Management Plan (A001) 
	
      COR 
	
      1 
	
      Within 30 Calendar days after contract award; update
      quarterly 

	
      3 
	
      3.1.1. 
	
      Final Integrated Master Schedule (CDRL A001) 
	
      COR 
	
      1 
	
      Within 30 Calendar days after contract award; update
      quarterly 

	
      4 
	
      3.1.1. 
	
      Risk Management Plan (CDRL A001) 
	
      COR 
	
      1 
	
      Within 30 Calendar days after contract award; updated
      quarterly 

	
      5 
	
      3.1.2. 
	
      Quality Control Plan (CDRL A002) 
	
      COR 
	
      1 
	
      Within 30 Calendar days after contract award; update as
      needed; review quarterly 

	
      6 
	
      3.1.3. 
	
      IRB-approved Clinical Protocol for each Study Site (CDRL
      A003) 
	
      COR 
	
      1 
	
      Within 3 months of award of contract 

	
      7 
	
      3.1.3. 
	
      Statistical Analysis Plan (CDRL A003) 
	
      COR 
	
      1 
	
      Within 3 months of award of contract 

	
      8 
	
      3.1.3. 
	
      Clinical Monitoring Plan (CDRL A003) 
	
      COR 
	
      1 
	
      Within 3 months of award of contract 

	
      9 
	
      3.1.3. 
	
      Data Management Plan (CDRL A003) 
	
      COR 
	
      1 
	
      Within 3 months of award of contract 

	
      10 
	
      3.1.3. 
	
      Proposed Clinical Data Management System (CDRL A003)
    
	
      COR 
	
      1 
	
      Within 3 months of award of contract 

	
      11 
	
      3.1.3. 
	
      Sample Case Report Forms (CDRL A003) 
	
      COR 
	
      1 
	
      Within 3 months of award of contract 

	
      12 
	
      3.1.3. 
	
      End User Guidelines (CDRL A003) 
	
      COR 
	
      1 
	
      Within 3 months of award of contract 

	
      13 
	
      3.1.3. 
	
      Recruitment and Retention Plan for each Clinical Site(CDRL A003)
    
	
      COR 
	
      1 
	
      Within 3 months of award of contract

Page 11 of 41 

	
      Item 
	PWS Ref 
	Title 
	Distribution 
	
      E 
	Initial & Subsequent 

	
      14 
	
      3.1.4. 
	
      IRB Approvals (CDRL A004) 
	
      COR 
	
      1 
	
      Within 3 months of award of contract and prior to start
      of clinical trial 

	
      15 
	
      3.1.5. 
	
      Representative Test Articles (sent to study sites) (CDRL
      A005) 
	
      COR 
	
      1 
	
      Prior to start of clinical trial 

	
      16 
	
      3.1.5. 
	
      Contingency Manufacturing Plan (CDRL A005) 
	
      COR 
	
      1 
	
      Prior to start of clinical trial 

	
      17 
	
      3.2.1. 
	
      Conduct Clinical Trial (CDRL A006) 
	
      COR 
	
      1 
	
      Copy of agreement with each study site prior to the start
      of the trial; monthly status report 

	
      18 
	
      3.2.2. 
	
      Interim Clinical Study Report & Mitigation Plan (CDRL
      A007) 
	
      COR 
		
      Within 30 days of completion of n = 60 subjects (and/or a
      proportionate amount consistent with FDA guidance) 

	
      19 
	
      3.3.1. 
	
      Final Clinical Study Report (CDRL A008) 
	
      COR 
	
      1 
	
      Within 75 days after completion of study 

	
      20 
	
      3.3.2. 
	
      FDA Submission Packet (CDRL A009) 
	
      COR 
	
      1 
	
      Concurrently with FDA submission 

	
      21 
	
      3.3.3. 
	
      Final Report 
	
      COR 
	
      1 
	
      Within 30 days after end of contract 

	
      22 
	
      3.3.4. 
	
      Technical Data Packet (CDRL A010) 
	
      COR 
	
      1 
	
      Seven (7) business days upon request and final TDP at end
      of contract 

	
      23 
	
      3.4.1. 
	
      FDA cleared PoNSTM Devices 
	
      COR 
	
      N A 
	
    Within 10 business days of FDA clearance (2 devices)    

	
      24 
	
      3.5.1. 
	
      Monthly Progress, Status, and Management Reports (CDRL
      A011) 
	
      COR 
	
      1 
	
      Monthly reports due the 10th day of each
      month. 

	
      25 
	
      3.5.1. 
	
      Quarterly Progress, Status, and Management Reports (CDRL
      A011) 
	
      COR 
	
      1 
	
      Quarterly reports due the 15th day after end
      of each quarter. 

	
      26 
	
      3.5.1. 
	
      Annual Progress, Status, and Management Reports (CDRL
      A011) 
	
      COR 
		
      Annual reports due the 15th day after end of
      each year 

	
      27 
	
      3.5.2. 
	
      Production or Delivery Problem Reports (CDRL A012)
	
      COR 
	
      1 
	
      Within 2 weeks of identification of deviation to schedule
      or scope of any task as needed 

	
      28 
	
      3.5.3. 
	
      Annual Program Reviews 
	
      IPT 
	
      N A 
	
      Annually In Process Review at Fort Detrick, MD 

	
      29 
	
      3.5.4. 
	
      FDA Communication and Study Reports (CDRL A013)
	
      COR 
	
      1 
	
      Concurrently and/or 3 business days as applicable (see
      PWS 3.1.18.) 

Page 12 of 41 

	Item    	PWS Ref 	Title 	Distribution 	E 	Initial & Subsequent 
	30 	3.5.5. 	Trip Reports 	COR 	1 	Within 5 business days for Government requested
      travel 

5. List of Acronyms: 

	AMEDD 	Army Medical Department 
	CFR 	Code of Federal Regulations 
	CONUS 	Continental United States (excludes Alaska and
      Hawaii) 
	COR 	Contracting Officer Representative 
	CRO 	Clinical Research Organization 
	DD250 	Department of Defense Form 250 (Receiving
      Report) 
	DD254 	Department of Defense Contract Security
      Requirement List 
	DFARS 	Defense Federal Acquisition Regulation
      Supplement 
	DoD 	Department of Defense 
	FAR 	Federal Acquisition Regulation 
	FDA 	United States Food and Drug Administration
  
	HIPAA 	Health Insurance Portability and Accountability
      Act of 1996 
	IAW 	In Accordance With 
	IMS 	Integrated Master Schedule 
	IRB 	Institutional Review Board 
	KO 	Contracting Officer 
	n 	Number of Research Subjects 
	NA 	Not Applicable 
	NDA 	Non-disclosure Agreement 
	NHC 	NeuroHabilitation Corporation 
	OCI 	Organizational Conflict of Interest 
	OCONUS 	Outside Continental United States (includes
      Alaska and Hawaii) 
	ODC 	Other Direct Costs 
	PM 	Project Manager 
	PoNSTM 	Portable Neuromodulation Stimulator 
	PWS 	Performance Work Statement 
	QA 	Quality Assurance 
	QAP 	Quality Assurance Program 
	QASP 	Quality QAP Assurance Surveillance Plan 
	QC 	Quality Control 
	QCP 	Quality Control Plan 
	QSR 	Quality Systems Regulations 
	TDP 	Technical Data Packet 
	TBI 	Traumatic Brain Injury 
	USAMMA 	United States Army Medical Materiel Agency
  
	USAMRMC 	United States Medical Research and Materiel
      Command 

CONTRACTOR MANPOWER REPORTING 

Contractor Manpower Reporting (CMR) for the Base Period. Input
for Contract Services information in the web site operated and maintained by the
Assistant Secretary of the Army (Manpower & Reserve Affairs). See the
"Contractor Manpower Reporting" clause for specific reporting information.
Reporting period will be the period of performance not to exceed 12 months
ending 30 September of each Government fiscal year and must be reported by 31 October of each calendar year. The Contract SHALL provide
evidence of compliance with the CMR requirement to the Contracting Officer's
Representative (COR), Contract Specialist, and Contracting Officer no later than
15 November of each calendar year. 

Page 13 of 41 

The contractor does not propose any additional costs related to
Contractor Manpower Reporting.

CLAUSES INCORPORATED BY FULL TEXT 

CONTRACTOR MANPOWER REPORTING (CMR) - (ACCOUNTING FOR
CONTRACT SERVICES) (APR 2011) (USAMRAA) 

The Office of the Assistant Secretary of the Army (Manpower
& Reserve Affairs) operates and maintains a secure Army data collection site
where the contractor will report ALL contractor manpower (including
sub-contractor manpower) required for performance of this contract. The
contractor is required to completely fill in all the information in the format
using the following web address: https://cmra.army.mil. The required information
includes: (l) Contract Number; (2) Delivery Order Number (If applicable); (3)
Task Order Number (If applicable); (4) Requiring Activity Unit Identification
Code (UIC); (5) Command; (6) Contractor Contact Information; (7) Federal Service
Code (FSC); (8) Direct Labor Hours; (9) Direct Labor Dollars; and, (10)
Location. In the event the Contracting Officer's Representative
(COR)/Contracting Officer's Technical Representative (COTR) has not entered
their data requirements first, the contractor must also enter the COR/COTR
required data with the exception of fund cite, obligations, and disbursement
data. The CMRA help desk can be reach at   any
technical questions. The help desk can also be contacted via email:
As part of its quote or offer, the contractor
will also provide the estimated total cost (if any) incurred to comply with this
reporting requirement. The reporting period will be the period of performance
not to exceed 12 months ending 30 September of each government fiscal year and
must be reported by 31 October of each calendar year. 

Page 14 of 41 

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 
	0003 	Destination 	Government 	Destination 	Government 

CLAUSES INCORPORATED BY REFERENCE 

	52.246-5 	Inspection Of Services Cost-Reimbursement 	APR 1984 
	52.246-8 	Inspection Of Research And Development Cost
      Reimbursement 	MAY 2001 

Page 15 of 41 

Section F - Deliveries or Performance 

DELIVERY INFORMATION 

	CLIN 	DELIVERY DATE 	QUANTITY 	SHIP TO ADDRESS 	DODAAC 
	  	  	  	  	  
	0001 	POP 01-JUL-2015 TO 	N/A 	US ARMY MEDICAL MATERIEL AGENCY 	W25MWY 
	  	31-DEC-2016 	  	US ARMY MEDICAL MATERIEL AGENCY 	  
	  	  	  	 	  
	  	  	  	 	  
	  	  	  	 	  
	  	  	  	FOB: Destination 	  
	  	  	  	  	  
	0002 	POP 01-JUL-2015 TO 	N/A 	(SAME AS PREVIOUS LOCATION) 	W25MWY 
	  	30-DEC-2016 	  	FOB: Destination 	  
	  	  	  	  	  
	0003 	POP 01-JUL-2015 TO 	N/A 	(SAME AS PREVIOUS LOCATION) 	W25MWY 
	  	30-DEC-2016 	  	FOB: Destination 	  

CLAUSES INCORPORATED BY REFERENCE 

	52.242-15 	Stop-Work Order 	AUG 1989 

Page 16 of 41 

Section G - Contract Administration Data 

ACCOUNTING AND APPROPRIATION DATA 

	AA: 09720142015013000018N10337374255 	R.0011882.4.11 	6100.9000021001 
	COST CODE: A7466 	  	  
	AMOUNT: $2,996,244.00 	  	  
	CIN GFEBS001055363000001: $217,975.21 	  	  
	CIN GFEBS001055363000002: $2,763,289.24 	  	  
	CIN GFEBS001055363000003: $14,979.55 	  	  

CLAUSES INCORPORATED BY REFERENCE 

	252.201-7000 	Contracting Officer's Representative 	DEC 1991 

CLAUSES INCORPORATED BY FULL TEXT 

52.004-4002 Contractor Performance Assessment Reporting
System (CPARS) (USAMRAA) (September 2009)

The Contractor Performance Assessment Reporting System (CPARS)
has been adopted electronically to capture assessment data and manage the
evaluation process. CPARS is used to assess a contractor's performance and
provide a record, both positive and negative, on a given contract during a
specific period of time. The CPARS Automated Information System (AIS) collection
tool and other CPARS information can be accessed at
https://www.cpars.csd.disa.mil. CPARS collects contractor performance
information and passes it to the Federal Past Performance Information Retrieval
System (PPIRS) where it can be retrieved by Federal Government Agencies
including the DoD Services. The CPARS process is designed with a series of
checks and balances to facilitate the objective and consistent evaluation of
contractor performance. Both government and contractor program management
perspectives are captured on the CPAR form and together make a complete CPAR.
The Contractor shall assign and provide to the Contracting Officer's
Representative (COR), within 10 calendar days after award, the name, title,
email address and phone number of the designated Contractor Representative (CR)
within their firm who will be responsible for CPAR information and reviewing the
Government's proposed assessment for the period of performance. A User ID and
Password for the CPARS will be provided to the designated CR for this purpose of
accessing the CPARS. The CR has the authority to: Receive the Government
evaluation; Review/comment/return the evaluation to the Government within 30
calendar days after the Government's evaluation is completed; Request a meeting
to discuss the CPAR. This meeting must be requested, in writing, no later than
seven calendar days from the receipt of the CPAR and must be held during the
contractor’s 30-day review period. The CR must either concur or nonconcur to
each CPAR.

Page 17 of 41 

CLAUSES INCORPORATED BY FULL TEXT 

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). 

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). 

Invoice 2-in-1 Services (Services Only) 

(Contracting Officer: Insert applicable document type(s). Note:
If a “Combo” document type is identified but not supportable by the Contractor's
business systems, an “Invoice” (stand-alone) and “Receiving Report”
(stand-alone) document type may be used instead.) 

(2) Inspection/acceptance location. The Contractor shall select
the following inspection/acceptance location(s) in WAWF, as specified by the
contracting officer. 

Not Applicable 

(Contracting Officer: Insert inspection and acceptance
locations or “Not applicable”.) 

Page 18 of 41 

(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 	W25MWY 
	Ship To Code 	W25MWY 
	Ship From Code 	___
	Mark For Code 	___
	Service Approver (DoDAAC) 	HAA391 
	Service Acceptor (DoDAAC) 	W25MWY 
	Accept at Other DoDAAC 	N/A 
	LPO DoDAAC 	N/A 
	DCAA Auditor DoDAAC 	HAA391 
	Other DoDAAC(s)
	N/A
  

(*Contracting Officer: Insert applicable DoDAAC information or
“See schedule” if multiple ship to/acceptance locations apply, or “Not
applicable.”) 

(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. 

 

(Contracting Officer: Insert applicable email addresses or “Not
applicable.”) 

(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. 

Not Applicable 

(Contracting Officer: Insert applicable information or “Not
applicable.”) 

(2) For technical WAWF help, contact the WAWF helpdesk at

(End of clause) 

Page 19 of 41 

Section H - Special Contract Requirements 

CLAUSES INCORPORATED BY FULL TEXT 

ORGANIZATIONAL AND CONSULTANT CONFLICTS OF INTEREST (MAR
1999) (USAMRAA) 

a. It is recognized by the parties hereto that the effort
performed by the contractor under this contract is of a nature that it creates a
potential organizational conflict of interest as is contemplated under the FAR
Subpart 9.5.

b. In the performance of this contract, the contractor may have
access to data which is procurement sensitive or is proprietary to other
companies, Government consultants or advisors, or the Government. The contractor
agrees that he will not utilize such procurement sensitive or proprietary data
in performance of future competitive contracts, for studies in the same field,
procured either through sealed bids or competitive negotiations. The contractor
further agrees not to act as a subcontractor or consultant to any other prime
contractor or subcontractor seeking to utilize such data. 

c. The contractor will include the provisions of paragraphs a
and b in every first tier subcontract for performance of any portion of this
requirement. 

d. This clause shall have effect from 01 July 2015 to 31
December 2016. 

CLAUSES INCORPORATED BY FULL TEXT 

GOOD LABORATORY PRACTICES (DEC 2006) (USAMRAA)

The conduct of studies on investigational new drugs or devices
shall comply with the GOOD LABORATORY PRACTICE (GLP) FOR NONCLINICAL LABORATORY
STUDIES regulations 21 CFR 58. The contractor shall notify the Administrative
Contracting Officer by telephone immediately upon announcement by a
representative of the Food and Drug Administration (FDA) of an inspection of
studies performed under this contract. In addition to the FDA representative,
the Contracting Officer's Representative (COR) shall have access to the
contractor's records and specimens. With reference to paragraph 58.195(h) of the
GLP regulations, the contractor shall notify the COR in writing in addition to
the FDA, should the contractor go out of business and/or transfer the records
during the periods prescribed in paragraph 58.195. On expiration or termination
of the contract, the contractor shall notify the COR of any remaining unused
test articles. 

CLAUSES INCORPORATED BY FULL TEXT 

INVESTIGATING AND REPORTING POSSIBLE SCIENTIFIC MISCONDUCT
(MAR 1999) (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. 

Page 20 of 41 

c. The contractor agrees to: 
(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. 

PROHIBITION OF HUMAN RESEARCH (JUN 2013 ) (USAMRAA) 

** PROHIBITION – READ FURTHER FOR DETAILS **

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.

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 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 noncompliance 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. 

Page 21 of 41 

52.035 -4035 PROHIBITION OF USE OF LABORATORY ANIMALS (JUN
2013) (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
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 ther terminations of the award. 

52.035 -4036 PROHIBITION OF USE OF HUMAN CADAVERS (JUN 2013)
(USAMRAA) 

** PROHIBITION – READ FURTHER FOR DETAILS**

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
(https://mrmc.amedd.army.mil/index.cfm?pageid=research_ protections.overview).
The USAMRMC Office of Research Protections (ORP) is the Action Office
 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, 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.

CONTRACTOR IDENTIFICATION (DEC 2005) (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.

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.

Page 22 of 41 

REPORTS, MANUSCRIPTS AND PUBLIC RELEASES (DEC 2006)
(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:

(l) "This work is supported by the US Army Medical Research and
Materiel Command under Contract No. W81XWH-15-C-0096" 

(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." 

TRAVEL (JULY 2007) (USAMRAA) 

a. Approval of Foreign Travel. The cost of foreign travel is
allowable only when the specific written approval of the Contracting Officer is
obtained prior to commencing the trip. Approval shall be requested at least 90
calendar days before the scheduled departure date in order that all necessary
clearances may be processed. Each individual trip must be approved separately,
even though it may have been included in a previously approved budget. Foreign
travel under this contract is defined as any travel outside of the United States
and its territories and possessions.

b. Costs incurred by contractor personnel on official company
business, whether foreign travel and/or domestic/local travel, are allowable,
subject to the limitations contained in the Federal Acquisition Regulation (FAR)
clause at 52.216 -7, Allowable Cost and Payment, incorporated into this
contract. 

Page 23 of 41 

Section I - Contract Clauses 

REGULATORY RIGHTS 
REGULATORY RIGHTS IN EVENT OF
PRODUCT DEVELOPMENT FAILURES

This contract includes research with an investigational drug,
biologic or medical device that is regulated by the U.S. Food and Drug
Administration (FDA) and requires FDA pre-market approval or clearance before
commercial marketing may begin. It is expected that this contract will result in
the FDA clearance and commercialization of the Portable Neuromodulation
Stimulator (PoNS) device. The Contractor is the sponsor of the Regulatory
Application (an investigational new drug application (IND), investigational
device exemption (IDE), new drug application (NDA), biologics license
application (BLA), premarket approval application (PMA), or 510(k) pre-market
notification filing (510(k)) or another regulatory filing submitted to FDA) that
controls the research under this contract. As the sponsor of the Regulatory
Application to FDA (as the terms “sponsor” and “applicant” are defined or used
in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20), the
Contractor has certain standing before the FDA that entitles it to exclusive
communications related to the Regulatory Application. This provision protects
the return on research and development investment made by the U.S. Army Medical
Research and Materiel Command (USAMRMC) in the event of certain regulatory
product development failures related to the Technology. 

The Contractor agrees to the following:

a. Contractor will, within three (3) business days of receipt,
provide USAMRMC with all communications and summaries thereof, both formal and
informal, to or from FDA regarding the Technology and ensure that USAMRMC
representatives are given advance notice of and are invited to participate with
at least two (2) representatives in any formal or informal sponsor meetings with
FDA; 

b. If contract is to be terminated or is about to expire prior
to the time the Contractor obtains FDA approval or clearance ; or the Contractor
fails to commercially market the regulated technology within three (3) years
after the FDA issues approval or clearance, the Contractor, upon the request of
the Government:

(i) shall transfer possession, ownership and sponsorship or
holdership of any Regulatory Application (including any associated expedited
review designation, priority review voucher, or marketing exclusivity
eligibility or award), regulatory correspondence, and supporting regulatory
information related to the Technology to USAMRMC or its designee;

(ii) shall inform FDA of the transfer of sponsorship or
holdership of the Regulatory Application transferred under section (c)(i)
above.

c. The terms of this provision and its derivative
obligations:

(i) will be included in any license, sale or transfer by the
Contractor to a third party of any intellectual property covered by section (b)
above.

(ii) will survive the acquisition or merger of the Contractor
by or with any third party. 

(iii) will be included in any subcontracts relating to the
development of the Technology. 

(iv) will survive the expiration of this contract. 

CLAUSES INCORPORATED BY REFERENCE 

	52.202-1 	Definitions 	NOV 2013 

Page 24 of 41 

	
      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 

	
      52.203-12 
	
      Limitation On Payments To Influence Certain Federal
      Transactions 
	
      OCT 2010 

	
      52.203-17 
	
      Contractor Employee Whistleblower Rights and Requirement
      To Inform Employees of Whistleblower Rights 
	
      APR 2014 

	
      52.204-4 
	
      Printed or Copied Double-Sided on Postconsumer Fiber
      Content Paper 
	
      MAY 2011 

	
      52.204-9 
	
      Personal Identity Verification of Contractor Personnel
      
	
      JAN 2011 

	
      52.204-10 
	
      Reporting Executive Compensation and First-Tier
      Subcontract Awards 
	
      JUL 2013 

	
      52.204-13 
	
      System for Award Management Maintenance 
	
      JUL 2013 

	
      52.209-6 
	
      Protecting the Government's Interest When Subcontracting
      With Contractors Debarred, Suspended, or Proposed for Debarment 
	
      AUG 2013 

	
      52.209-9 
	
      Updates of Publicly Available Information Regarding
      Responsibility Matters 
	
      JUL 2013 

	
      52.209-10 
	
      Prohibition on Contracting With Inverted Domestic
      Corporations 
	
      DEC 2014 

	
      52.215-8 
	
      Order of Precedence--Uniform Contract Format 
	
      OCT 1997 

	
      52.215-23 
	
      Limitations on Pass-Through Charges 
	
      OCT 2009 

	
      52.217-2 
	
      Cancellation Under Multiyear Contracts 
	
      OCT 1997 

	
      52.219-8 
	
      Utilization of Small Business Concerns 
	
      OCT 2014 

	
      52.222-1 
	
      Notice To The Government Of Labor Disputes 
	
      FEB 1997 

	
      52.222-3 
	
      Convict Labor 
	
      JUN 2003 

	
      52.222-50 
	
      Combating Trafficking in Persons 
	
      MAR 2015 

	
      52.223-6 
	
      Drug-Free Workplace 
	
      MAY 2001 

	
      52.223-17 
	
      Affirmative Procurement of EPA-Designated Items in
      Service and Construction Contracts 
	
      MAY 2008 

	
      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 

	
      52.227-1 Alt I 
	
      Authorization And Consent (Dec 2007) - Alternate I

	
      APR 1984 

	
      52.227-2 
	
      Notice And Assistance Regarding Patent And Copyright
      Infringement 
	
      DEC 2007 

	
      52.228-7 
	
      Insurance--Liability To Third Persons 
	
      MAR 1996 

	
      52.232-23 
	
      Assignment Of Claims 
	
      MAY 2014 

	
      52.232-33 
	
      Payment by Electronic Funds Transfer--System for Award
      Management 
	
      JUL 2013 

	
      52.232-39 
	
      Unenforceability of Unauthorized Obligations 
	
      JUN 2013 

	
      52.232-40 
	
      Providing Accelerated Payments to Small Business
      Subcontractors 
	
      DEC 2013 

	
      52.233-1 
	
      Disputes 
	
      MAY 2014 

	
      52.233-3 Alt I 
	
      Protest After Award (Aug 1996) - Alternate I 
	
      JUN 1985 

	
      52.233-4 
	
      Applicable Law for Breach of Contract Claim 
	
      OCT 2004 

	
      52.239-1 
	
      Privacy or Security Safeguards 
	
      AUG 1996 

	
      52.242-1 
	
      Notice of Intent to Disallow Costs 
	
      APR 1984 

	
      52.242-2 
	
      Production Progress Reports 
	
      APR 1991 

	
      52.242-3 
	
      Penalties for Unallowable Costs 
	
      MAY 2014 

	
      52.242-4 
	
      Certification of Final Indirect Costs 
	
      JAN 1997 

Page 25 of 41 

	
      52.242-13 
	
      Bankruptcy 
	
      JUL 1995 

	
      52.242-13 
	
      Bankruptcy 
	
      JUL 1995 

	
      52.243-6 
	
      Change Order Accounting 
	
      APR 1984 

	
      52.244-5 
	
      Competition In Subcontracting 
	
      DEC 1996 

	
      52.244-6 
	
      Subcontracts for Commercial Items 
	
      OCT 2014 

	
      52.246-25 
	
      Limitation Of Liability--Services 
	
      FEB 1997 

	
      52.249-6 
	
      Termination (Cost Reimbursement) 
	
      MAY 2004 

	
      52.249-14 
	
      Excusable Delays 
	
      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 

	
      252.204-7000 
	
      Disclosure Of Information 
	
      AUG 2013 

	
      252.204-7003 
	
      Control Of Government Personnel Work Product 
	
      APR 1992 

	
      252.204-7012 
	
      Safeguarding of Unclassified Controlled Technical
      Information 
	
      NOV 2013 

	
      252.209-7004 
	
      Subcontracting With Firms That Are Owned or Controlled By
      The Government of a Terrorist Country 
	
      DEC 2014 

	
      252.223-7004 
	
      Drug Free Work Force 
	
      SEP 1988 

	
      252.225-7993 (Dev) 
	
      Prohibition on Contracting with the Enemy (Deviation)
    
	
      SEP 2014 

	
      252.227-7001 
	
      Release Of Past Infringement 
	
      AUG 1984 

	
      252.227-7010 
	
      License to Other Government Agencies 
	
      AUG 1984 

	
      252.227-7013 
	
      Rights in Technical Data--Noncommercial Items 
	
      FEB 2014 

	
      252.227-7014 
	
      Rights in Noncommercial Computer Software and
      Noncommercial Computer Software Documentation 
	
      FEB 2014 

	
      252.227-7016 
	
      Rights in Bid or Proposal Information 
	
      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 

	
      252.232-7003 
	
      Electronic Submission of Payment Requests and Receiving
      Reports 
	
      JUN 2012 

	
      252.246-7001 
	
      Warranty Of Data 
	
      MAR 2014 

CLAUSES INCORPORATED BY FULL TEXT 

52.216 -7     ALLOWABLE COST AND PAYMENT
(JUN 2013)

(a) Invoicing.

(1) The Government will make payments to the Contractor when
requested as work progresses, but (except for small business concerns) not more
often than once every 2 weeks, in amounts determined to be allowable by the
Contracting Officer in accordance with Federal Acquisition Regulation (FAR)
subpart 31.2 in effect on the date of this contract and the terms of this
contract. The Contractor may submit to an authorized representative of the
Contracting Officer, in such form and reasonable detail as the representative
may require, an invoice or voucher supported by a statement of the claimed
allowable cost for performing this contract. 

(2) Contract financing payments are not subject to the interest
penalty provisions of the Prompt Payment Act. Interim payments made prior to the
final payment under the contract are contract financing payments, except interim
payments if this contract contains Alternate I to the clause at 52.232 -25. 

(3) The designated payment office will make interim payments
for contract financing on the 30th day after the designated billing office
receives a proper payment request. 

Page 26 of 41 

In the event that the Government requires an audit or other
review of a specific payment request to ensure compliance with the terms and
conditions of the contract, the designated payment office is not compelled to
make payment by the specified due date. 

(b) Reimbursing costs. (1) For the purpose of reimbursing
allowable costs (except as provided in subparagraph (b)(2) of the clause, with
respect to pension, deferred profit sharing, and employee stock ownership plan
contributions), the term "costs" includes only--

(i) Those recorded costs that, at the time of the request for
reimbursement, the Contractor has paid by cash, check, or other form of actual
payment for items or services purchased directly for the contract;

(ii) When the Contractor is not delinquent in paying costs of
contract performance in the ordinary course of business, costs incurred, but not
necessarily paid, for--

(A) Supplies and services purchased directly for the contract
and associated financing payments to subcontractors, provided payments
determined due will be made-- 

(1) In accordance with the terms and conditions of a
subcontract or invoice; and 

(2) Ordinarily within 30 days of the submission of the
Contractor's payment request to the Government; 

(B) Materials issued from the Contractor's inventory and placed
in the production process for use on the contract; 

(C) Direct labor; 

(D) Direct travel; 

(E) Other direct in-house costs; and

(F) Properly allocable and allowable indirect costs, as shown
in the records maintained by the Contractor for purposes of obtaining
reimbursement under Government contracts; and

(iii) The amount of financing payments that have been paid by
cash, check, or other forms of payment to subcontractors. 

(2) Accrued costs of Contractor contributions under employee
pension plans shall be excluded until actually paid unless-- 

(i) The Contractor's practice is to make contributions to the
retirement fund quarterly or more frequently; and 

(ii) The contribution does not remain unpaid 30 days after the
end of the applicable quarter or shorter payment period (any contribution
remaining unpaid shall be excluded from the Contractor's indirect costs for
payment purposes). 

(3) Notwithstanding the audit and adjustment of invoices or
vouchers under paragraph (g) of this clause, allowable indirect costs under this
contract shall be obtained by applying indirect cost rates established in
accordance with paragraph (d) of this clause.

(4) Any statements in specifications or other documents
incorporated in this contract by reference designating performance of services
or furnishing of materials at the Contractor's expense or at no cost to the
Government shall be disregarded for purposes of cost-reimbursement under this
clause.

(c) Small business concerns. A small business concern may
receive more frequent payments than every 2 weeks. 

Page 27 of 41 

(d) Final indirect cost rates. (1) Final annual indirect cost
rates and the appropriate bases shall be established in accordance with Subpart
42.7 of the Federal Acquisition Regulation (FAR) in effect for the period
covered by the indirect cost rate proposal.

(2)(i) The Contractor shall submit an adequate final indirect
cost rate proposal to the Contracting Officer (or cognizant Federal agency
official) and auditor within the 6-month period following the expiration of each
of its fiscal years. Reasonable extensions, for exceptional circumstances only,
may be requested in writing by the Contractor and granted in writing by the
Contracting Officer. The Contractor shall support its proposal with adequate
supporting data. 

(ii) The proposed rates shall be based on the Contractor's
actual cost experience for that period. The appropriate Government
representative and the Contractor shall establish the final indirect cost rates
as promptly as practical after receipt of the Contractor's proposal. 

(iii) An adequate indirect cost rate proposal shall include the
following data unless otherwise specified by the cognizant Federal agency
official: 

(A) Summary of all claimed indirect expense rates, including
pool, base, and calculated indirect rate. 

(B) General and Administrative expenses (final indirect cost
pool). Schedule of claimed expenses by element of cost as identified in
accounting records (Chart of Accounts). 

(C) Overhead expenses (final indirect cost pool). Schedule of
claimed expenses by element of cost as identified in accounting records (Chart
of Accounts) for each final indirect cost pool. 

(D) Occupancy expenses (intermediate indirect cost pool).
Schedule of claimed expenses by element of cost as identified in accounting
records (Chart of Accounts) and expense reallocation to final indirect cost
pools. 

(E) Claimed allocation bases, by element of cost, used to
distribute indirect costs. 

(F) Facilities capital cost of money factors computation. 

(G) Reconciliation of books of account (i.e., General Ledger)
and claimed direct costs by major cost element. 

(H) Schedule of direct costs by contract and subcontract and
indirect expense applied at claimed rates, as well as a subsidiary schedule of
Government participation percentages in each of the allocation base amounts.

(I) Schedule of cumulative direct and indirect costs claimed
and billed by contract and subcontract. 

(J) Subcontract information. Listing of subcontracts awarded to
companies for which the contractor is the prime or upper-tier contractor
(include prime and subcontract numbers; subcontract value and award type; amount
claimed during the fiscal year; and the subcontractor name, address, and point
of contact information). 

(K) Summary of each time-and-materials and labor-hour contract
information, including labor categories, labor rates, hours, and amounts; direct
materials; other direct costs; and, indirect expense applied at claimed rates.

(L) Reconciliation of total payroll per IRS form 941 to total
labor costs distribution. 

(M) Listing of decisions/agreements/approvals and description
of accounting/organizational changes. 

(N) Certificate of final indirect costs (see 52.242 -4,
Certification of Final Indirect Costs). 

Page 28 of 41 

(O) Contract closing information for contracts physically
completed in this fiscal year (include contract number, period of performance,
contract ceiling amounts, contract fee computations, level of effort, and
indicate if the contract is ready to close). 

(iv) The following supplemental information is not required to
determine if a proposal is adequate, but may be required during the audit
process: 

(A) Comparative analysis of indirect expense pools detailed by
account to prior fiscal year and budgetary data. 

(B) General organizational information and limitation on
allowability of compensation for certain contractor personnel. See 31.205 -6(p).
Additional salary reference information is available at
http://www.whitehouse.gov/omb/procurement_index_exec_comp/. 

(C) Identification of prime contracts under which the
contractor performs as a subcontractor.

(D) Description of accounting system (excludes contractors
required to submit a CAS Disclosure Statement or contractors where the
description of the accounting system has not changed from the previous year's
submission). 

(E) Procedures for identifying and excluding unallowable costs
from the costs claimed and billed (excludes contractors where the procedures
have not changed from the previous year's submission). 

(F) Certified financial statements and other financial data
(e.g., trial balance, compilation, review, etc.). 

(G) Management letter from outside CPAs concerning any internal
control weaknesses. 

(H) Actions that have been and/or will be implemented to
correct the weaknesses described in the management letter from subparagraph G)
of this section. 

(I) List of all internal audit reports issued since the last
disclosure of internal audit reports to the Government. 

(J) Annual internal audit plan of scheduled audits to be
performed in the fiscal year when the final indirect cost rate submission is
made. 

(K) Federal and State income tax returns. 

(L) Securities and Exchange Commission 10-K annual report. 

(M) Minutes from board of directors meetings. 

(N) Listing of delay claims and termination claims submitted
which contain costs relating to the subject fiscal year. 

(O) Contract briefings, which generally include a synopsis of
all pertinent contract provisions, such as: Contract type, contract amount,
product or service(s) to be provided, contract performance period, rate
ceilings, advance approval requirements, pre-contract cost allowability
limitations, and billing limitations. 

(v) The Contractor shall update the billings on all contracts
to reflect the final settled rates and update the schedule of cumulative direct
and indirect costs claimed and billed, as required in paragraph (d)(2)(iii)(I)
of this section, within 60 days after settlement of final indirect cost rates.

(3) The Contractor and the appropriate Government
representative shall execute a written understanding setting forth the final
indirect cost rates. The understanding shall specify (i) the agreed-upon final
annual indirect cost rates, (ii) the bases to which the rates apply, (iii) the
periods for which the rates apply, (iv) any specific indirect cost items treated
as direct costs in the settlement, and (v) the affected contract and/or
subcontract, identifying any with advance agreements or special terms and the
applicable rates. The understanding shall not change any monetary ceiling, contract obligation, or specific cost allowance or
disallowance provided for in this contract. The understanding is incorporated
into this contract upon execution.

Page 29 of 41 

(4) Failure by the parties to agree on a final annual indirect
cost rate shall be a dispute within the meaning of the Disputes clause.

(5) Within 120 days (or longer period if approved in writing by
the Contracting Officer) after settlement of the final annual indirect cost
rates for all years of a physically complete contract, the Contractor shall
submit a completion invoice or voucher to reflect the settled amounts and rates.
The completion invoice or voucher shall include settled subcontract amounts and
rates. The prime contractor is responsible for settling subcontractor amounts
and rates included in the completion invoice or voucher and providing status of
subcontractor audits to the contracting officer upon request. 

(6)(i) If the Contractor fails to submit a completion invoice
or voucher within the time specified in paragraph (d)(5) of this clause, the
Contracting Officer may-- 

(A) Determine the amounts due to the Contractor under the
contract; and 

(B) Record this determination in a unilateral modification to
the contract. 

(ii) This determination constitutes the final decision of the
Contracting Officer in accordance with the Disputes clause. 

(e) Billing rates. Until final annual indirect cost rates are
established for any period, the Government shall reimburse the Contractor at
billing rates established by the Contracting Officer or by an authorized
representative (the cognizant auditor), subject to adjustment when the final
rates are established. These billing rates--

(1) Shall be the anticipated final rates; and

(2) May be prospectively or retroactively revised by mutual
agreement, at either party's request, to prevent substantial overpayment or
underpayment.

(f) Quick-closeout procedures. Quick-closeout procedures are
applicable when the conditions in FAR 42.708(a) are satisfied.

(g) Audit. At any time or times before final payment, the
Contracting Officer may have the Contractor's invoices or vouchers and
statements of cost audited. Any payment may be (1) Reduced by amounts found by
the Contracting Officer not to constitute allowable costs or (2) Adjusted for
prior overpayments or underpayments.

(h) Final payment. (1) Upon approval of a completion invoice or
voucher submitted by the Contractor in accordance with paragraph (d)(5) of this
clause, and upon the Contractor's compliance with all terms of this contract,
the Government shall promptly pay any balance of allowable costs and that part
of the fee (if any) not previously paid.

(2) The Contractor shall pay to the Government any refunds,
rebates, credits, or other amounts (including interest, if any) accruing to or
received by the Contractor or any assignee under this contract, to the extent
that those amounts are properly allocable to costs for which the Contractor has
been reimbursed by the Government. Reasonable expenses incurred by the
Contractor for securing refunds, rebates, credits, or other amounts shall be
allowable costs if approved by the Contracting Officer. Before final payment
under this contract, the Contractor and each assignee whose assignment is in
effect at the time of final payment shall execute and deliver--

(i) An assignment to the Government, in form and substance
satisfactory to the Contracting Officer, of refunds, rebates, credits, or other
amounts (including interest, if any) properly allocable to costs for which the
Contractor has been reimbursed by the Government under this contract; and

Page 30 of 41 

(ii) A release discharging the Government, its officers,
agents, and employees from all liabilities, obligations, and claims arising out
of or under this contract, except--

(A) Specified claims stated in exact amounts, or in estimated
amounts when the exact amounts are not known;

(B) Claims (including reasonable incidental expenses) based
upon liabilities of the Contractor to third parties arising out of the
performance of this contract; provided, that the claims are not known to the
Contractor on the date of the execution of the release, and that the Contractor
gives notice of the claims in writing to the Contracting Officer within 6 years
following the release date or notice of final payment date, whichever is
earlier; and

(C) Claims for reimbursement of costs, including reasonable
incidental expenses, incurred by the Contractor under the patent clauses of this
contract, excluding, however, any expenses arising from the Contractor's
indemnification of the Government against patent liability.

(End of clause) 

52.216 -12     COST-SHARING CONTRACT--NO
FEE (APR 1984) 

(a) The Government shall not pay to the Contractor a fee for
performing this contract. 

(b) After paying $100,000.00 of the Government's share of the
total estimated cost of performance shown in the Schedule, the Contracting
Officer may withhold further payment of allowable cost until a reserve is set
aside in an amount that the Contracting Officer considers necessary to protect
the Government's interest. This reserve shall not exceed one percent of the
Government's share of the total estimated cost shown in the Schedule or
$100,000.00, whichever is less. 

(End of clause) 

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) 

52.227 -11     PATENT RIGHTS--OWNERSHIP BY
THE CONTRACTOR (MAY 2014) 

(a) As used in this clause-- 

Invention means any invention or discovery that is or may be
patentable or otherwise protectable under title 35 of the U.S. Code, or any
variety of plant that is or may be protectable under the Plant Variety
Protection Act (7 U.S.C. 2321, et seq.) 

Made means-- 

Page 31 of 41 

(1) When used in relation to any invention other than a plant
variety, the conception or first actual reduction to practice of the invention;
or 

(2) When used in relation to a plant variety, that the
Contractor has at least tentatively determined that the variety has been
reproduced with recognized characteristics. 

Nonprofit organization means a university or other institution
of higher education or an organization of the type described in section
501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C. 501(c)) and exempt
from taxation under section 501(a) of the Internal Revenue Code (26 U.S.C.
501(a)), or any nonprofit scientific or educational organization qualified under
a State nonprofit organization statute. 

Practical application means to manufacture, in the case of a
composition of product; to practice, in the case of a process or method; or to
operate, in the case of a machine or system; and, in each case, under such
conditions as to establish that the invention is being utilized and that its
benefits are, to the extent permitted by law or Government regulations,
available to the public on reasonable terms. 

Subject invention means any invention of the Contractor made in
the performance of work under this contract. 

(b) Contractor's rights. (1) Ownership. The Contractor may
retain ownership of each subject invention throughout the world in accordance
with the provisions of this clause. 

(2) License. (i) The Contractor shall retain a nonexclusive
royalty-free license throughout the world in each subject invention to which the
Government obtains title, unless the Contractor fails to disclose the invention
within the times specified in paragraph (c) of this clause. The Contractor's
license extends to any domestic subsidiaries and affiliates within the corporate
structure of which the Contractor is a part, and includes the right to grant
sublicenses to the extent the Contractor was legally obligated to do so at
contract award. The license is transferable only with the written approval of
the agency, except when transferred to the successor of that part of the
Contractor's business to which the invention pertains. 

(ii) The Contractor's license may be revoked or modified by the
agency to the extent necessary to achieve expeditious practical application of
the subject invention in a particular country in accordance with the procedures
in FAR 27.302(i)(2) and 27.304 -1(f). 

(c) Contractor's obligations. (1) The Contractor shall disclose
in writing each subject invention to the Contracting Officer within 2 months
after the inventor discloses it in writing to Contractor personnel responsible
for patent matters. The disclosure shall identify the inventor(s) and this
contract under which the subject invention was made. It shall be sufficiently
complete in technical detail to convey a clear understanding of the subject
invention. The disclosure shall also identify any publication, on sale (i.e.,
sale or offer for sale), or public use of the subject invention, or whether a
manuscript describing the subject invention has been submitted for publication
and, if so, whether it has been accepted for publication. In addition, after
disclosure to the agency, the Contractor shall promptly notify the Contracting
Officer of the acceptance of any manuscript describing the subject invention for
publication and any on sale or public use. 

(2) The Contractor shall elect in writing whether or not to
retain ownership of any subject invention by notifying the Contracting Officer
within 2 years of disclosure to the agency. However, in any case where
publication, on sale, or public use has initiated the 1-year statutory period
during which valid patent protection can be obtained in the United States, the
period for election of title may be shortened by the agency to a date that is no
more than 60 days prior to the end of the statutory period. 

(3) The Contractor shall file either a provisional or a
nonprovisional patent application or a Plant Variety Protection Application on
an elected subject invention within 1 year after election. However, in any case
where a publication, on sale, or public use has initiated the 1-year statutory
period during which valid patent protection can be obtained in the United
States, the Contractor shall file the application prior to the end of that
statutory period. If the Contractor files a provisional application, it shall
file a nonprovisional application within 10 months of the filing of the
provisional application. The Contractor shall file patent applications in
additional countries or international patent offices within either 10 months of the first filed patent
application (whether provisional or nonprovisional) or 6 months from the date
permission is granted by the Commissioner of Patents to file foreign patent
applications where such filing has been prohibited by a Secrecy Order. 

Page 32 of 41 

(4) The Contractor may request extensions of time for
disclosure, election, or filing under paragraphs (c)(1), (c)(2), and (c)(3) of
this clause. 

(d) Government's rights--(1) Ownership. The Contractor shall
assign to the agency, on written request, title to any subject invention-- 

(i) If the Contractor fails to disclose or elect ownership to
the subject invention within the times specified in paragraph (c) of this
clause, or elects not to retain ownership; provided, that the agency may request
title only within 60 days after learning of the Contractor's failure to disclose
or elect within the specified times. 

(ii) In those countries in which the Contractor fails to file
patent applications within the times specified in paragraph (c) of this clause;
provided, however, that if the Contractor has filed a patent application in a
country after the times specified in paragraph (c) of this clause, but prior to
its receipt of the written request of the agency, the Contractor shall continue
to retain ownership in that country. 

(iii) In any country in which the Contractor decides not to
continue the prosecution of any application for, to pay the maintenance fees on,
or defend in reexamination or opposition proceeding on, a patent on a subject
invention. 

(2) License. If the Contractor retains ownership of any subject
invention, the Government shall have a nonexclusive, nontransferable,
irrevocable, paid-up license to practice, or have practiced for or on its
behalf, the subject invention throughout the world. 

(e) Contractor action to protect the Government's interest. (1)
The Contractor shall execute or have executed and promptly deliver to the agency
all instruments necessary to-- 

(i) Establish or confirm the rights the Government has
throughout the world in those subject inventions in which the Contractor elects
to retain ownership; and 

(ii) Assign title to the agency when requested under paragraph
(d) of this clause and to enable the Government to obtain patent protection and
plant variety protection for that subject invention in any country. 

(2) The Contractor shall require, by written agreement, its
employees, other than clerical and nontechnical employees, to disclose promptly
in writing to personnel identified as responsible for the administration of
patent matters and in the Contractor's format, each subject invention in order
that the Contractor can comply with the disclosure provisions of paragraph (c)
of this clause, and to execute all papers necessary to file patent applications
on subject inventions and to establish the Government's rights in the subject
inventions. The disclosure format should require, as a minimum, the information
required by paragraph (c)(1) of this clause. The Contractor shall instruct such
employees, through employee agreements or other suitable educational programs,
as to the importance of reporting inventions in sufficient time to permit the
filing of patent applications prior to U.S. or foreign statutory bars. 

(3) The Contractor shall notify the Contracting Officer of any
decisions not to file a nonprovisional patent application, continue the
prosecution of a patent application, pay maintenance fees, or defend in a
reexamination or opposition proceeding on a patent, in any country, not less
than 30 days before the expiration of the response or filing period required by
the relevant patent office. 

(4) The Contractor shall include, within the specification of
any United States nonprovisional patent or plant variety protection application
and any patent or plant variety protection certificate issuing thereon covering
a subject invention, the following statement, “This invention was made with
Government support under (identify the contract) awarded by (identify the
agency). The Government has certain rights in the invention.” 

Page 33 of 41 

(f) Reporting on utilization of subject inventions. The
Contractor shall submit, on request, periodic reports no more frequently than
annually on the utilization of a subject invention or on efforts at obtaining
utilization of the subject invention that are being made by the Contractor or
its licensees or assignees. The reports shall include information regarding the
status of development, date of first commercial sale or use, gross royalties
received by the Contractor, and other data and information as the agency may
reasonably specify. The Contractor also shall provide additional reports as may
be requested by the agency in connection with any march-in proceeding undertaken
by the agency in accordance with paragraph (h) of this clause. The Contractor
also shall mark any utilization report as confidential/proprietary to help
prevent inadvertent release outside the Government. As required by 35 U.S.C.
202(c)(5), the agency will not disclose that information to persons outside the
Government without the Contractor's permission. 

(g) Preference for United States industry. Notwithstanding any
other provision of this clause, neither the Contractor nor any assignee shall
grant to any person the exclusive right to use or sell any subject invention in
the United States unless the person agrees that any products embodying the
subject invention or produced through the use of the subject invention will be
manufactured substantially in the United States. However, in individual cases,
the requirement for an agreement may be waived by the agency upon a showing by
the Contractor or its assignee that reasonable but unsuccessful efforts have
been made to grant licenses on similar terms to potential licensees that would
be likely to manufacture substantially in the United States, or that under the
circumstances domestic manufacture is not commercially feasible. 

(h) March-in rights. The Contractor acknowledges that, with
respect to any subject invention in which it has retained ownership, the agency
has the right to require licensing pursuant to 35 U.S.C. 203 and 210(c), and in
accordance with the procedures in 37 CFR 401.6 and any supplemental regulations
of the agency in effect on the date of contract award. 

(i) Special provisions for contracts with nonprofit
organizations. If the Contractor is a nonprofit organization, it shall-- 

(1) Not assign rights to a subject invention in the United
States without the written approval of the agency, except where an assignment is
made to an organization that has as one of its primary functions the management
of inventions, provided, that the assignee shall be subject to the same
provisions as the Contractor; 

(2) Share royalties collected on a subject invention with the
inventor, including Federal employee co-inventors (but through their agency if
the agency deems it appropriate) when the subject invention is assigned in
accordance with 35 U.S.C. 202(e) and 37 CFR 401.10; 

(3) Use the balance of any royalties or income earned by the
Contractor with respect to subject inventions, after payment of expenses
(including payments to inventors) incidental to the administration of subject
inventions for the support of scientific research or education; and 

(4) Make efforts that are reasonable under the circumstances to
attract licensees of subject inventions that are small business concerns, and
give a preference to a small business concern when licensing a subject invention
if the Contractor determines that the small business concern has a plan or
proposal for marketing the invention which, if executed, is equally as likely to
bring the invention to practical application as any plans or proposals from
applicants that are not small business concerns; provided, that the Contractor
is also satisfied that the small business concern has the capability and
resources to carry out its plan or proposal. The decision whether to give a
preference in any specific case will be at the discretion of the Contractor.

(5) Allow the Secretary of Commerce to review the Contractor's
licensing program and decisions regarding small business applicants, and
negotiate changes to its licensing policies, procedures, or practices with the
Secretary of Commerce when the Secretary's review discloses that the Contractor
could take reasonable steps to more effectively implement the requirements of
paragraph (i)(4) of this clause. 

(j) Communications.

Page 34 of 41 

(k) Subcontracts. (1) The Contractor shall include the
substance of this clause, including this paragraph (k), in all subcontracts for
experimental, developmental, or research work to be performed by a small
business concern or nonprofit organization. 

(2) The Contractor shall include in all other subcontracts for
experimental, developmental, or research work the substance of the patent rights
clause required by FAR Subpart 27.3. 

(3) At all tiers, the patent rights clause must be modified to
identify the parties as follows: references to the Government are not changed,
and the subcontractor has all rights and obligations of the Contractor in the
clause. The Contractor shall not, as part of the consideration for awarding the
subcontract, obtain rights in the subcontractor's subject inventions. 

(4) In subcontracts, at any tier, the agency, the
subcontractor, and the Contractor agree that the mutual obligations of the
parties created by this clause constitute a contract between the subcontractor
and the agency with respect to the matters covered by the clause; provided,
however, that nothing in this paragraph is intended to confer any jurisdiction
under the Contract Disputes statute in connection with proceedings under
paragraph (h) of this clause. 

(End of clause)

52.243 -2    CHANGES--COST-REIMBURSEMENT (AUG
1987) - ALTERNATE I (APR 1984) 

(a) The Contracting Officer may at any time, by written order,
and without notice to the sureties, if any, make changes within the general
scope of this contract in any one or more of the following: 

(1) Description of services to be performed. 

(2) Time of performance (i.e., hours of the day, days of the
week, etc.). 

(3) Place of performance of the services. 

(b) If any such change causes an increase or decrease in the
estimated cost of, or the time required for, performance of any part of the work
under this contract, whether or not changed by the order, or otherwise affects
any other terms and conditions of this contract, the Contracting Officer shall
make an equitable adjustment in the (1) estimated cost, delivery or completion
schedule, or both; (2) amount of any fixed fee; and (3) other affected terms and
shall modify the contract accordingly. 

(c) The Contractor must assert its right to an adjustment under
this clause within 30 days from the date of receipt of the written order.
However, if the Contracting Officer decides that the facts justify it, the
Contracting Officer may receive and act upon a proposal submitted before final
payment of the contract. 

(d) Failure to agree to any adjustment shall be a dispute under
the Disputes clause. However, nothing in this clause shall excuse the Contractor
from proceeding with the contract as changed. 

(e) Notwithstanding the terms and conditions of paragraphs (a)
and (b) above, the estimated cost of this contract and, if this contract is
incrementally funded, the funds allotted for the performance of this contract,
shall not be increased or considered to be increased except by specific written
modification of the contract indicating the new contract estimated cost and, if
this contract is incrementally funded, the new amount allotted to the contract.
Until this modification is made, the Contractor shall not be obligated to
continue performance or incur costs beyond the point established in the
Limitation of Cost or Limitation of Funds clause of this contract. 

(End of clause) 

Page 35 of 41 

52.243 -2     CHANGES--COST-REIMBURSEMENT
(AUG 1987) - ALTERNATE V (APR 1984) 

(a) The Contracting Officer may at any time, by written order,
and without notice to the sureties, if any, make changes within the general
scope of this contract in any one or more of the following: 

(1) Drawings, designs, or specifications. 

(2) Method of shipment or packing. 

(3) Place of inspection, delivery, or acceptance. 

(b) If any such change causes an increase or decrease in the
estimated cost of, or the time required for, performance of any part of the work
under this contract, whether or not changed by the order, or otherwise affects
any other terms and conditions of this contract, the Contracting Officer shall
make an equitable adjustment in the (1) estimated cost, delivery or completion
schedule, or both; (2) amount of any fixed fee; and (3) other affected terms and
shall modify the contract accordingly. 

(c) The Contractor must assert its right to an adjustment under
this clause within 30 days from the date of receipt of the written order.
However, if the Contracting Officer decides that the facts justify it, the
Contracting Officer may receive and act upon a proposal submitted before final
payment of the contract. 

(d) Failure to agree to any adjustment shall be a dispute under
the Disputes clause. However, nothing in this clause shall excuse the Contractor
from proceeding with the contract as changed. 

(e) Notwithstanding the terms and conditions of paragraphs (a)
and (b) above, the estimated cost of this contract and, if this contract is
incrementally funded, the funds allotted for the performance of this contract,
shall not be increased or considered to be increased except by specific written
modification of the contract indicating the new contract estimated cost and, if
this contract is incrementally funded, the new amount allotted to the contract.
Until this modification is made, the Contractor shall not be obligated to
continue performance or incur costs beyond the point established in the
Limitation of Cost or Limitation of Funds clause of this contract. 

(End of clause) 

52.243 -7   NOTIFICATION OF CHANGES (APR 1984) 

(a) Definitions.

"Contracting Officer," as used in this clause, does not include
any representative of the Contracting Officer.

"Specifically authorized representative (SAR)," as used in this
clause, means any person the Contracting Officer has so designated by written
notice (a copy of which shall be provided to the Contractor) which shall refer
to this subparagraph and shall be issued to the designated representative before
the SAR exercises such authority. 

(b) Notice. The primary purpose of this clause is to obtain
prompt reporting of Government conduct that the Contractor considers to
constitute a change to this contract. Except for changes identified as such in
writing and signed by the Contracting Officer, the Contractor shall notify the
Administrative Contracting Officer in writing, within 15 calendar days from the
date that the Contractor identifies any Government conduct (including actions,
inactions, and written or oral communications) that the Contractor regards as a
change to the contract terms and conditions. On the basis of the most accurate
information available to the Contractor, the notice shall state-- 

(1) The date, nature, and circumstances of the conduct regarded
as a change; 

Page 36 of 41 

(2) The name, function, and activity of each Government
individual and Contractor official or employee involved in or knowledgeable
about such conduct; 

(3) The identification of any documents and the substance of
any oral communication involved in such conduct; 

(4) In the instance of alleged acceleration of scheduled
performance or delivery, the basis upon which it arose; 

(5) The particular elements of contract performance for which
the Contractor may seek an equitable adjustment under this clause, including--

(i) What contract line items have been or may be affected by
the alleged change; 

(ii) What labor or materials or both have been or may be added,
deleted, or wasted by the alleged change; 

(iii) To the extent practicable, what delay and disruption in
the manner and sequence of performance and effect on continued performance have
been or may be caused by the alleged change; 

(iv) What adjustments to contract price, delivery schedule, and
other provisions affected by the alleged change are estimated; and 

(6) The Contractor's estimate of the time by which the
Government must respond to the Contractor's notice to minimize cost, delay or
disruption of performance. 

(c) Continued performance. Following submission of the notice
required by (b) above, the Contractor shall diligently continue performance of
this contract to the maximum extent possible in accordance with its terms and
conditions as construed by the Contractor, unless the notice reports a direction
of the Contracting Officer or a communication from a SAR of the Contracting
Officer, in either of which events the Contractor shall continue performance;
provided, however, that if the Contractor regards the direction or communication
as a change as described in (b) above, notice shall be given in the manner
provided. All directions, communications, interpretations, orders and similar
actions of the SAR shall be reduced to writing and copies furnished to the
Contractor and to the Contracting Officer. The Contracting Officer shall
countermand any action which exceeds the authority of the SAR. 

(d) Government response. The Contracting Officer shall
promptly, within 15 calendar days after receipt of notice, respond to the notice
in writing. In responding, the Contracting Officer shall either-- 

(1) Confirm that the conduct of which the Contractor gave
notice constitutes a change and when necessary direct the mode of further
performance; 

(2) Countermand any communication regarded as a change; 

(3) Deny that the conduct of which the Contractor gave notice
constitutes a change and when necessary direct the mode of further performance;
or 

(4) In the event the Contractor's notice information is
inadequate to make a decision under (1), (2), or (3) above, advise the
Contractor what additional information is required, and establish the date by
which it should be furnished and the date thereafter by which the Government
will respond. 

(e) Equitable adjustments. 

(1) If the Contracting Officer confirms that Government conduct
effected a change as alleged by the Contractor, and the conduct causes an
increase or decrease in the Contractor's cost of, or the time required for,
performance of any part of the work under this contract, whether changed or not
changed by such conduct, an equitable adjustment shall be made-- 

Page 37 of 41 

(i) In the contract price or delivery schedule or both; and

(ii) In such other provisions of the contract as may be
affected. 

(2) The contract shall be modified in writing accordingly. In
the case of drawings, designs or specifications which are defective and for
which the Government is responsible, the equitable adjustment shall include the
cost and time extension for delay reasonably incurred by the Contractor in
attempting to comply with the defective drawings, designs or specifications
before the Contractor identified, or reasonably should have identified, such
defect. When the cost of property made obsolete or excess as a result of a
change confirmed by the Contracting Officer under this clause is included in the
equitable adjustment, the Contracting Officer shall have the right to prescribe
the manner of disposition of the property. The equitable adjustment shall not
include increased costs or time extensions for delay resulting from the
Contractor's failure to provide notice or to continue performance as provided,
respectively, in (b) and (c) above. 

Note: The phrases “contract price” and “cost” wherever they
appear in the clause, may be appropriately modified to apply to
cost-reimbursement or incentive contracts, or to combinations thereof. 

(End of clause) 

52.244 -2     SUBCONTRACTS (OCT 2010) -
ALTERNATE I (JUN 2007) 

(a) Definitions. As used in this clause-- 

Approved purchasing system means a Contractor's purchasing
system that has been reviewed and approved in accordance with Part 44 of the
Federal Acquisition Regulation (FAR). 

Consent to subcontract means the Contracting Officer's written
consent for the Contractor to enter into a particular subcontract. 

Subcontract means any contract, as defined in FAR Subpart 2.1,
entered into by a subcontractor to furnish supplies or services for performance
of the prime contract or a subcontract. It includes, but is not limited to,
purchase orders, and changes and modifications to purchase orders. 

(b) When this clause is included in a fixed-price type
contract, consent to subcontract is required only on unpriced contract actions
(including unpriced modifications or unpriced delivery orders), and only if
required in accordance with paragraph (c) or (d) of this clause. 

(c) If the Contractor does not have an approved purchasing
system, consent to subcontract is required for any subcontract that-- 

(1) Is of the cost-reimbursement, time-and-materials, or
labor-hour type; or 

(2) Is fixed-price and exceeds-- 

(i) For a contract awarded by the Department of Defense, the
Coast Guard, or the National Aeronautics and Space Administration, the greater
of the simplified acquisition threshold or 5 percent of the total estimated cost
of the contract; or 

(ii) For a contract awarded by a civilian agency other than the
Coast Guard and the National Aeronautics and Space Administration, either the
simplified acquisition threshold or 5 percent of the total estimated cost of the
contract. 

(d) If the Contractor has an approved purchasing system, the
Contractor nevertheless shall obtain the Contracting Officer's written consent
before placing the following subcontracts: N/A 

Page 38 of 41 

(e)(1) The Contractor shall notify the Contracting Officer
reasonably in advance of placing any subcontract or modification thereof for
which consent is required under paragraph (b), (c), or (d) of this clause,
including the following information: 

(i) A description of the supplies or services to be
subcontracted. 

(ii) Identification of the type of subcontract to be used. 

(iii) Identification of the proposed subcontractor. 

(iv) The proposed subcontract price. 

(v) The subcontractor's current, complete, and accurate cost or
pricing data and Certificate of Current Cost or Pricing Data, if required by
other contract provisions. 

(vi) The subcontractor's Disclosure Statement or Certificate
relating to Cost Accounting Standards when such data are required by other
provisions of this contract. 

(vii) A negotiation memorandum reflecting-- 

(A) The principal elements of the subcontract price
negotiations; 

(B) The most significant considerations controlling
establishment of initial or revised prices; 

(C) The reason cost or pricing data were or were not required;

(D) The extent, if any, to which the Contractor did not rely on
the subcontractor's cost or pricing data in determining the price objective and
in negotiating the final price; 

(E) The extent to which it was recognized in the negotiation
that the subcontractor's cost or pricing data were not accurate, complete, or
current; the action taken by the Contractor and the subcontractor; and the
effect of any such defective data on the total price negotiated; 

(F) The reasons for any significant difference between the
Contractor's price objective and the price negotiated; and 

(G) A complete explanation of the incentive fee or profit plan
when incentives are used. The explanation shall identify each critical
performance element, management decisions used to quantify each incentive
element, reasons for the incentives, and a summary of all trade-off
possibilities considered. 

(2) If the Contractor has an approved purchasing system and
consent is not required under paragraph (c), or (d) of this clause, the
Contractor nevertheless shall notify the Contracting Officer reasonably in
advance of entering into any (i) cost-plus-fixed-fee subcontract, or (ii)
fixed-price subcontract that exceeds either the simplified acquisition threshold
or 5 percent of the total estimated cost of this contract. The notification
shall include the information required by paragraphs (e)(1)(i) through
(e)(1)(iv) of this clause. 

(f) Unless the consent or approval specifically provides
otherwise, neither consent by the Contracting Officer to any subcontract nor
approval of the Contractor's purchasing system shall constitute a
determination-- 

(1) Of the acceptability of any subcontract terms or
conditions; 

(2) Of the allowability of any cost under this contract; or

(3) To relieve the Contractor of any responsibility for
performing this contract. 

Page 39 of 41 

(g) No subcontract or modification thereof placed under this
contract shall provide for payment on a cost-plus-a-percentage-of-cost basis,
and any fee payable under cost-reimbursement type subcontracts shall not exceed
the fee limitations in FAR 15.404 -4(c)(4)(i). 

(h) The Contractor shall give the Contracting Officer immediate
written notice of any action or suit filed and prompt notice of any claim made
against the Contractor by any subcontractor or vendor that, in the opinion of
the Contractor, may result in litigation related in any way to this contract,
with respect to which the Contractor may be entitled to reimbursement from the
Government. 

(i) The Government reserves the right to review the
Contractor's purchasing system as set forth in FAR Subpart 44.3. 

(j) Paragraphs (c) and (e) of this clause do not apply to the
following subcontracts, which were evaluated during negotiations: N/A 

(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
www/usamraa.army.mil

(End of clause) 

52.252 -6     AUTHORIZED DEVIATIONS IN
CLAUSES (APR 1984) 

(a) The use in this solicitation or contract of any Federal
Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is
indicated by the addition of "(DEVIATION)" after the date of the clause. 

(b) The use in this solicitation or contract of any Federal
Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is
indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of clause) 

252.225 -7043     ANTITERRORISM/FORCE
PROTECTION POLICY FOR DEFENSE CONTRACTORS OUTSIDE THE UNITED STATES (MAR 2006)

(a) Definition. United States, as used in this clause, means,
the 50 States, the District of Columbia, and outlying areas. 

(b) Except as provided in paragraph (c) of this clause, the
Contractor and its subcontractors, if performing or traveling outside the United
States under this contract, shall-- 

Page 40 of 41 

(1) Affiliate with the Overseas Security Advisory Council, if
the Contractor or subcontractor is a U.S. entity; 

(2) Ensure that Contractor and subcontractor personnel who are
U.S. nationals and are in-country on a non-transitory basis, register with the
U.S. Embassy, and that Contractor and subcontractor personnel who are third
country nationals comply with any security related requirements of the Embassy
of their nationality; 

(3) Provide, to Contractor and subcontractor personnel,
antiterrorism/force protection awareness information commensurate with that
which the Department of Defense (DoD) provides to its military and civilian
personnel and their families, to the extent such information can be made
available prior to travel outside the United States; and 

(4) Obtain and comply with the most current antiterrorism/force
protection guidance for Contractor and subcontractor personnel. 

(c) The requirements of this clause do not apply to any
subcontractor that is-- (1) A foreign government; (2) A representative of a
foreign government; or (3) A foreign corporation wholly owned by a foreign
government. 

(d) Information and guidance pertaining to DoD
antiterrorism/force protection can be obtained from HQDA-AT; 

(End of clause) 

Page 41 of 41 

Section J - List of Documents, Exhibits and Other Attachments

Exhibit/Attachment Table of Contents 

	DOCUMENT TYPE 	DESCRIPTION 	PAGES 	DATE 
	
      Attachment 1 
	
      Quality Assurance Surveillance Plan 
	
      8 
	
      22-JUN-2015 

	Attachment 10 	CDRL A009 	2 	26-MAR-2015 
	Attachment 11 	CDRL A010 	2 	26-MAR-2015 
	Attachment 12 	CDRL A011 	2 	26-MAR-2015 
	Attachment 13 	CDRL A012 	2 	26-MAR-2015 
	Attachment 14 	CDRL A013 	2 	26-MAR-2015 
	Attachment 2 	CDRL A001 	2 	26-MAR-2015 
	Attachment 3 	CDRL A002 	2 	26-MAR-2015 
	Attachment 4 	CDRL A003 	2 	26-MAR-2015 
	Attachment 5 	CDRL A004 	2 	26-MAR-2015 
	Attachment 6 	CDRL A005 	2 	26-MAR-2015 
	Attachment 7 	CDRL A006 	2 	26-MAR-2015 
	Attachment 8 	CDRL A007 	2 	26-MAR-2015 
	Attachment 9 	CDRL A008 	2 	26-MAR-2015Helius Medical Technologies, Inc.: Exhibit Montel Consulting Contract - Filed by newsfilecorp.com

April13, 2016 

Philippe Deschamps 
President & CEO 
Helius Medical
Technologies 
41 University Drive, Suite 400 
Newtown PA 18940

	 	Re: 	Consultant Agreement ("Agreement")
  

Dear Phil,: 

Helius Medical Technologies ("Company") and Mentel Media, Inc
("Lender") f/s/o Mentel Williams ("Artist") have agreed as follows: 

1.     Services/Expenses:
Company hereby engages Lender to furnish the non- exclusive services of Artist
as a consultant subject to Artist's reasonable availability. Such services to be
provided in the New York area unless mutually approved by the parties in which
case Lender's/Artist's expenses to be paid by Company. Any other expenses of
Lender/Artist are subject to pre-approval by Company. Services to include media
interviews to promote the clinical trial registration to include but not limited
to a satellite TV tour, as well as ongoing media/marketing strategy development
for consumer launch, strategic partnership development and military meetings as
needed. 

2.     Term: The term
("Term") of this Agreement shall commence on April 15, 2016, and shall continue
for twelve months, or until replaced by a spokesperson agreement with Lender,
whichever comes first. Either party may terminate this Agreement upon thirty
(30) days prior written notice. 

3.     Fees: Lender shall be
paid during the Term the sum of fifteen thousand ($15,000.00) per month payable
on a monthly basis. 

4.     Results and Proceeds:
Company shall own all rights in and to the results and proceeds of Lender'sA!
rtist's services hereunder as a "work made-for-hire." To the extent that such
work or the results and proceeds thereof is not deemed a work made-for-hire,
Lender/Artist irrevocably assign, transfer and convey to Company any such work
and/or results and proceeds. 

5.     Confidential
Information: Lender/Artist acknowledge and understand that the confidential
information of Company is valuable, special and unique to its business, that
such business depends on such confidential information and that Company desires
to protect such confidential information by keeping it confidential for its use
and benefit. Based on the foregoing, Lender/Artist agree not to disclose either
while rendering services on behalf of Company or at any time thereafter, to any
person not then employed by the Company, or not then engaged to render services
to Company, any confidential information obtained by Lender/Artist while rendering services for Company; and
Lender/Artist agree that upon termination of this Agreement or at any other time
that Company may request so, Lender/Artist shall promptly deliver to Company all
such confidential materials. 

6.     Independent Contractor: (a)
Lende-r has the full right, power, authority and legal capacity to enter into
and perform this Agreement without any consent from any other party; (b) Lender
shall pay and report all income and other taxes applicable to Lender's services
hereunder or any compensation therefor and Company shall have no obligation or
liability for any such tax or reporting obligation; and (c) all works written,
created, composed or delivered by Lender/Artist hereunder shall be wholly
original with Lender/Artist, except only to the extent provided to Lender/Artist
by Company for use by Lender/Artist hereunder, and shall not violate or infringe
upon any rights of any other party of any kind whatsoever. All agreements,
representations and warranties made by Lender in this Agreement shall survive
the execution, delivery, performance and termination of this Agreement. 

7.     Representations and Warranties;
Indemnifications: 

(a)     Each party hereby represents
and warrants that it has the right to enter into this Agreement and to grant the
rights herein. Further, Lender/Artist represents and warrants that all results
and proceeds of Lender's/Artist's services ("Results and Proceeds") are and
shall be original with Lender/Artist or in the public domain and, to the best of
Lender'sA! rtist's knowledge, do not and shall not violate or infringe upon
copyright, right of privacy or any other right of any person or entity. 

(b)     To the fullest extent permitted by
law, each party shall, at its own expense, defend, indemnify and hold harmless
the other party (including in the case of Company, its parents, affiliates and
subsidiaries and their successors and their respective officers, directors,
employees and agents and licensees) from and against any and all allegations
asserted in any third party claim, investigation, demand, suit, cause of action
or proceeding (collectively "Claims") to the extent actually arising from or
related to any of the following: (i) any breach of this Agreement by the
indemnifying party; (ii) any failure by the indemnifying party to comply with
any applicable law; (iii) any bodily injury or loss of property resulting from
any act or omission of the indemnifying party to the extent not as a result of
the act or failure to act of the indemnified party unless such act or failure to
act constitutes negligence; (iv) the Results and Proceeds: (A) constitutes
libel, slander, and/or defamation; (B) constitutes an infringement of any
trademark (excluding Company supplied trademarks), copyright, or other
intellectual property right of a third party; (C) constitutes piracy plagiarism,
misappropriation of another's idea, confidential information, trade secrets, or
unfair competition; (D) constitutes an invasion of rights of privacy of
publicity; or (E) results in any claim, suit, or proceeding arising out of
obligations under a union agreement relating to the production or use of any of
the Results and Proceeds to the extent that such result from the indemnifying
party's breach of the terms of this Agreement or otherwise are caused by the
indemnifying party. In addition, (i) Lender/Artist shall, at it own expense
indemnify and hold harmless Company for any loss, unauthorized disclosure or
unauthorized use of confidential information by Lender/Artist or its employees
and (ii) Company shall, at its own expense, defend, indemnify and hold harmless
Lender/Artist from and against any and all Claims related to the development,
production, distribution and/or exploitation of the Results and Proceeds and any
element thereof excluding, however, Claims related to breaches by Lender/Artist
of its representations and warranties herein. 

8.     Miscellaneous: 

(a)     This Agreement sets forth
the entire agreement and understanding of the parties hereto, and, effective on
the commencement of the Term hereof, supersedes all prior agreements,
arrangements, and understandings. 

{b)     This Agreement shall be governed
and construed in accordance with the laws of the State of California. 

(c)     In the event of a breach of any
provision hereof by Company or its successors, licensees or assigns,
Lender/Artist agree that their sole remedy shall be an action at law for money
damages, if any, and in no event shall Lender/Artist seek or have the right to
seek or obtain any injunctive or other equitable relief, or enjoin, interfere
with or otherwise prohibit the development, production, exhibition,
distribution, advertising and/or exploitation of the any rights granted to
Company hereunder. 

Very truly yours, 

By: __”Melanie McLaughlin”___ 
Melanie McLaughlin,
President 

Montel Media, Inc. 

___”Montel Williams”________ 
Montel Williams
(“Artist" 

AGREED TO AND ACCEPTED: Helius Medical Technologies, Inc. 

By: ____”Phil Deschamps”____ 
Phil Deschamps, CEO

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