Document:

Helius Medical Technologies, Inc. - Exhibit 10.2 - Filed by newsfilecorp.com

 

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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 Chris Sult at
USAMRAA, ATTN: Chris Sult, MRMC-AAA-SD, 820 Chandler Street, Fort Detrick, MD
21702-5014 or christopher.m.sult.civ@mail.mil or 301-619-1342.

The Contracting Officer for this contract is Barry Sayer at
USAMRAA, ATTN: Barry Sayer, MRMC-AAA-SD, 820 Chandler Street, Fort Detrick, MD
21702-5014 or barry.g.sayer.civ@mail.mil or 301-619-2375.

The Contracting Officer’s Representative for this contract is
Scott Colmyer at USAMMA, ATTN: Scott Colmyer, 693 Neiman Street, Fort Detrick,
MD 21702 or scott.d.colmyer.civ@mail.mil or 301-619-6982. 

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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   	 

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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.

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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. 

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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). 

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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). 

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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). 

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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 

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	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.) 

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	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. 

W81XWH-15-C-0096 

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 703-695-5103 or 703-695-5058 for any
technical questions. The help desk can also be contacted via email:
contractormanpower@hqda.army.mil. 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. 

W81XWH-15-C-0096 

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Section E - Inspection and Acceptance 

 

INSPECTION AND ACCEPTANCE TERMS 

Supplies/services will be inspected/accepted at: 

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

W81XWH-15-C-0096 

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Section F - Deliveries or Performance 

 

DELIVERY INFORMATION 

	CLIN 	DELIVERY DATE 	QUANTITY 	SHIP TO ADDRESS 	DODAAC 
	  	  	  	  	  
	0001 

	POP 01-JUL-2015 TO
      

      31-DEC-2016 

	N/A
      

	US ARMY MEDICAL MATERIEL AGENCY
      

      US ARMY MEDICAL MATERIEL AGENCY 
693 NEIMAN STREET 
FREDERICK MD
      21702 
301-619-4518 
FOB: Destination 	W25MWY
      

    

	  	  	  	  	  
	0002 
	POP 01-JUL-2015 TO
      

      30-DEC-2016 	N/A 
	(SAME AS PREVIOUS LOCATION)
      

      FOB: Destination 	W25MWY 

	  	  	  	  	  
	0003 
	POP 01-JUL-2015 TO
      

      30-DEC-2016 	N/A 
	(SAME AS PREVIOUS LOCATION)
      

      FOB: Destination 	W25MWY

 

CLAUSES INCORPORATED BY REFERENCE 

 

	52.242-15 	Stop-Work Order 	AUG 1989 

W81XWH-15-C-0096 

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.

W81XWH-15-C-0096 

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”.) 

W81XWH-15-C-0096 

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. 

Scott.d.colmyer.civ@mail.mil 

(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
866-618-5988. 

(End of clause) 

W81XWH-15-C-0096 

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. 

W81XWH-15-C-0096 

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. 

W81XWH-15-C-0096 

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
(hrpo@amedd.army.mil) for this policy. Approval must be obtained from the Head
of the Army organization that is supporting/funding the activity involving
cadavers as described in the Army Policy for Use of Human Cadavers. For certain
activities involving cadavers, 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.

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

W81XWH-15-C-0096 

Page 22 of 41 

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.

W81XWH-15-C-0096 

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

W81XWH-15-C-0096 

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 

W81XWH-15-C-0096 

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. 

W81XWH-15-C-0096 

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. 

W81XWH-15-C-0096 

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). 

W81XWH-15-C-0096 

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.

W81XWH-15-C-0096 

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

W81XWH-15-C-0096 

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-- 

W81XWH-15-C-0096 

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. 

W81XWH-15-C-0096 

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.” 

W81XWH-15-C-0096 

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.

W81XWH-15-C-0096 

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) 

W81XWH-15-C-0096 

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; 

W81XWH-15-C-0096 

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-- 

W81XWH-15-C-0096 

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 

W81XWH-15-C-0096 

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. 

W81XWH-15-C-0096 

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-- 

W81XWH-15-C-0096 

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; telephone, DSN
222-9832 or commercial (703) 692-9832.

(End of clause) 

W81XWH-15-C-0096 

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 10.3 - Filed by newsfilecorp.com

COVER SHEET 
Master Cooperative Research and
Development Agreement (CRADA) 

[NOTE: This Cover Sheet is for internal management purposes
only. It is not part of the Agreement and neither party is bound to anything
contained in it] 

Title: Collaboration to advance the Portable
Neuromodulation Stimulator (PoNSTM) device through FDA approval for assisted
physical therapy in the treatment of soldiers and others with balance and gait
disorder. 

	Effective Date: 	1 February 2013 	USAMRMC Control No.
      W81XWH-13-0145 
	Expiration Date: 	31 December 2015 	DA/TTPO Control No.

	Primary NTIS Subject Code/Title: 	334510 Electromedical and Electrotherapeutic
      Apparatus Manufacturing 
	Secondary NTIS Subject Code/Title: 	N/A 
	STO Code/Title: 	N/A 
	RAD: 	USAMRMC CCCRP (RAD2) 

Concurrence obtained from appropriate RAD/USSAMDA/CBMS-JPMO
program managers: YES 

	Laboratories: 	U.S. Army Medical Materiel Agency
    
	  	693 Neiman Street 
	  	Fort Detrick, MD 21702-5001

	  	 
	  	U.S. Army Medical Materiel
      Development Activity 
	  	1430 Veterans Drive 
	  	Fort Detrick, MD 21702 
	  	 
	Lab's Technical POCs: 	Mr. Michael Husband for USAMMA
  
	  	Phone: 301-619-4329 
	  	Email:
      michael.husband@amedd.army.mil 
	  	 
	  	LTC David Shoemaker for USAMMDA
    
	  	david.r.shoemaker@us.army.mil
  
	  	301-619-7985 
	  	 
	Lab's Legal Counsel: 	Commander, U.S. Army Medical
      Research and Materiel Command 
	  	ATTN: MCMR-ZA-J (Mr. Jeremiah
      Kelly) 
	  	Fort Detrick, Frederick, MD
      21701-5012 
	  	Voice Phone: (301)
      619-6554            
      FAX Phone: (301) 619-5034 
	  	 
	Company POC: 	Mr. Philippe Deschamps 
	  	NeuroHabilitation Corporation
  
	  	208 Palmer Alley, Newtown PA
      18940 
	  	Phone: 614-596-2597 
	  	Email: pdeschamps409@gmail.com
  
	  	 
	
      Other Parties: 
	
      Advanced NeuroRehabilitation, LLC and its owners: Yuri P.
      Danilov, Mitchell E. Tyler, and Kurt A. Kaczmarek as inventors/background
      patent holders 

Summary: Many soldiers in the Armed Forces suffer from
balance and gait disorders subsequent to brain trauma from combat or other
etiologies. Neuromodulation stimulation with the PoNSTM has been shown to aid in
speeding up or increasing response to physical therapy in the treatment of
vestibular disorder. The PoNSTM is presently an experimental device that has been
successfully used in investigatory studies of human subjects with movement
disorders. Further testing and design development are required to facilitate
regulatory approval by the FDA and to meet the product requirements of its
eventual end users.

A COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT 

Among 
NeuroHabilitation Corporation (Cooperator)

Yuri P. Danilov, Mitchell E. Tyler, Kurt A. Kaczmarek (Background
Patent Owners) 
Advanced NeuroRehabilitation, LLC (Exclusive Licensee
of Background Patent) 

and 

US Army Medical Materiel Agency (USAMMA)
a subordinate
activity of the US Army Medical Research and Materiel Command (USAMRMC), in

collaboration with the Combat Casualty Care Research Program (CCCRP)

and 

US Army Medical Materiel Development Activity (USAMMDA)

(USAMMA and USAMMDA collectively as Laboratory) 

            Article
1 Background 

      
     1.00 This Agreement is entered into under the
authority of the Federal Technology Transfer Act of 1986, 15 U.S.C. 3710a,
et seq. 

            1.01
Laboratory, on behalf of the US Government, and Cooperator desire to cooperate
in research and development of the Portable Neuromodulation Stimulator (PoNSTM)
assisted physical therapy for the treatment of soldiers with balance and gait
disorder according to the attached Statement of Work (SOW) described in Appendix
A. NOW, THEREFORE, the parties agree as follows with the understanding that the
Background Patent Owners and Advanced NeuroRehabilitation, LLC, which holds an
exclusive license to the background patent, are included in this Agreement only
to the extent needed to fulfill responsibilities under Articles 8 and 9 and
Appendix B: 

            Article
2 Definitions 

            2.00
The following terms are defined for this Agreement as follows: 

            2.01
"Agreement" means this Cooperative Research and Development Agreement (CRADA).
The terms “Agreement” and “CRADA” are used interchangeably herein. 

            2.02
"Invention" and "Made" have the meanings set forth in Title 15 U.S.C. Section
3703(7) and (8). 

            2.03
"Proprietary Information" means information marked with a proprietary legend
which embodies trade secrets developed at private expense or which is
confidential business or financial information, provided that such information:

            (i)
is not generally known, or which becomes generally known or available during the
period of this Agreement from other sources without obligations concerning their
confidentiality; 

            (ii)
has not been made available by the owners to others without obligation
concerning its confidentiality;

            (iii)
is not already available to the receiving party without obligation concerning
its confidentiality; and 

	CRADA for PoNS Device 	1	Proprietary 

            (iv)
is not independently developed by or on behalf of the receiving party, without
reliance on the information received hereunder. 

            2.04
“Regulatory Application” means 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 the US Food and Drug Administration (FDA) related to a product or an
analogous foreign filing. The related terms, “sponsor” and “applicant,” are used
herein consistent with the definitions and/or usage found in 21 CFR §§3.2(c),
312.3, 600.3(t), 812.3(n), 812 Subpart C, and 814.20. 

            2.05
"Subject Data" means all recorded information first produced in the performance
of this Agreement. 

            2.06
"Subject Invention" means any Invention Made as a consequence of, or in relation
to, the performance of work under this Agreement.

            Article
3 Research Scope and Administration 

            3.00
Statement of Work. Research performed under this Agreement shall be
performed in accordance with the SOW incorporated as a part of this Agreement at
Appendix A. It is agreed that any descriptions, statements, or specifications in
the SOW shall be interpreted as goals and objectives of the services to be
provided under this Agreement and not requirements or warranties. Laboratory and
Cooperator will endeavor to achieve the goals and objectives of such services;
however, each party acknowledges that such goals and objectives, or any
anticipated schedule of performance, may not be achieved. 

            3.01
Review of Work. Periodic conferences shall be held between the parties
for the purpose of reviewing the progress of work. It is understood that the
nature of this research is such that completion within the period of performance
specified, or within the limits of financial support allocated, cannot be
guaranteed. Accordingly, all research will be performed in good faith. 

            3.02
Principal Investigator. Any work required by the Laboratory under the SOW
will be performed under the supervision of Michael Husband of USAMMA
(michael.husband@amedd.army.mil, 301-619-4329) and LTC David Shoemaker of
USAMMDA (david.r.shoemaker@us.army.mil, 301-619-7985) or other duly appointed
Army Principal Investigators (PIs) as may be designated for a given phase or
task of the CRADA, who, as designated Army PIs have responsibility for the
scientific and technical conduct of this project on behalf of their respective
Laboratory. Any work required by the Cooperator under the SOW will be performed
under the supervision of Mitchell E. Tyler, metyler1@wisc.edu, who has
responsibility for the scientific and technical conduct of this project on
behalf of the Cooperator. 

            3.03
Collaboration Changes. If at any time the co-PIs determine that the
research, regulatory, or other data dictate a substantial change in the
direction of the work, the parties shall make a good faith effort to agree on
any necessary change to the SOW, obtain concurrences from the cognizant CCCRP
Integrated Product Team (IPT) and/or working groups participating in the CRADA,
and make the change by written notice to the addresses listed in section 13.05
Notices. 

            3.04
Final Report. The parties shall prepare a final report of the results of
this project within six months after completing the SOW. 

            Article
4 Ownership and Use of Physical Property

            4.00
Ownership of Materials or Equipment. All materials or equipment developed
or acquired under this Agreement by the parties shall be the property of the
party which developed or acquired the property, except that government equipment
provided by Laboratory (1) which through mixed funding or mixed development must
be integrated into a larger system, or (2) which through normal use at the termination of the Agreement has a salvage value that is less
than the return shipping costs, shall become the property of Cooperator.

	CRADA for PoNS Device 	2	Proprietary 

            4.01
Use of Provided Materials. Both parties agree that any materials relating
to them which were provided by one party to the other party will be used for
research purposes only. Except as provided by Appendix B, the materials shall
not be sold, offered for sale, used for commercial purposes, or be furnished to
any other party without advance written approval from the provider's official
signing this Agreement or from another official to whom the authority has been
delegated, and any use or furnishing of material shall be subject to the
restrictions and obligations imposed by this Agreement. 

            4.02
Notwithstanding the foregoing, it is acknowledged that the PoNSTM is functionally
complete and subject to a pending patent application on behalf of the owner
thereof and that Laboratory shall not, without the prior written consent of
Cooperator, modify, improve, alter the PoNSTM or integrate it into
any larger system. It is the intent of the parties to this Agreement that no
ownership rights to the PoNSTM accrue to Laboratory in the
performance, or by virtue of, this CRADA. 

            Article
5 Financial Obligation 

            5.00
In accordance with Section III of the SOW: Cooperator will be responsible for
the cost of the ongoing design and development of the PoNSTM device
to ensure its commercial availability post investigation and FDA clearance; and
Laboratory will utilize government funds for the cost of research, testing and
submissions as described at Section III(A) of the SOW. Articles 5.01 through
5.04 only apply in the event that the parties subsequently decide and mutually
agree to use funds from Cooperator to cover some of the cost of Laboratory work
under this CRADA.

            5.01
Advance Payment. The performance of research by Laboratory under this
Agreement may be conditioned on the advance payment by Cooperator of
Laboratory's agreed upon costs for the performance of such research.

            5.02
Deposit Account. In the event that funds from Cooperator are required for
Laboratory performance of work under this CRADA, such funds shall be deposited
in a specifically designated Department of the Army deposit account, details of
which shall be provided if and when needed. The deposits shall be made by check
or money order and shall be made payable to DFAS with proper information to
identify this particular CRADA. 

            5.03
Insufficient and Excess Funds. Laboratory shall not be required to
continue its research and development activities under this Agreement if the
funds provided by Cooperator are insufficient to cover Laboratory's agreed upon
costs for such continued activities. Funds not expended by Laboratory shall be
returned to Cooperator upon Laboratory's submission of a final fiscal report to
Cooperator. 

            5.04
Accounting Records. Laboratory shall maintain separate and distinct
current accounts, records, and other evidence supporting all its expenditures
under this Agreement. Laboratory shall provide Cooperator a semi-annual report
accounting for the use of Cooperator's funds and a final fiscal report within
four months after completing the SOW or ending its research activities under
this Agreement. The accounts and records of Laboratory shall be available for
reasonable inspection and copying by Cooperator and its authorized
representative. 

            Article
6 Patent Rights 

            6.00
Reporting. The parties shall promptly report to each other all Subject
Inventions reported to either party by its employees. All Subject Inventions
Made during the performance of this Agreement shall be listed in the Final
Report required by this Agreement. 

            6.01
Cooperator Employee Inventions. Laboratory waives any ownership rights
the US Government may have in Subject Inventions Made by Cooperator employees
and agrees that Cooperator shall have the option to retain title in Subject
Inventions Made by Cooperator employees. Cooperator shall notify Laboratory promptly upon making this election and
agrees to timely file patent applications on Cooperator's Subject Invention at
its own expense. Cooperator agrees to grant to the US Government on Cooperator's
Subject Inventions a nonexclusive, nontransferable, irrevocable, paid-up license
in the patents covering a Subject Invention, to practice or have practiced,
throughout the world by, or on behalf of the US Government. The nonexclusive
license shall be evidenced by a confirmatory license agreement prepared by
Cooperator in a form satisfactory to Laboratory. 

	CRADA for PoNS Device 	3	Proprietary 

            6.02
Laboratory Employee Inventions. Laboratory shall have the initial option
to retain title to, and file patent application on, each Subject Invention Made
by its employees. The Laboratory agrees to grant an exclusive license to any
invention arising under this Agreement to which it has ownership to the
Cooperator in accordance with Title 15 U.S. Code Section 3710a, on terms
negotiated in good faith. Any invention arising under this Agreement is subject
to the retention by the US Government of nonexclusive, nontransferable,
irrevocable, paid-up license to practice, or have practiced, the invention
throughout the world by or on behalf of the US Government. 

            6.03
Joint Inventions. Any Subject Invention patentable under US patent law
which is Made jointly by Laboratory employees and Cooperator employees under the
Scope of Work of this Agreement shall be jointly owned by the parties. The
parties shall discuss together a filing strategy and filing expenses related to
the filing of the patent covering the Subject Invention. If a party decides not
to retain its ownership rights to a jointly owned Subject Invention, it shall
offer to assign such rights to the other party, pursuant to Paragraph 6.05,
below. Any invention arising under this Agreement is subject to the retention by
the US Government of nonexclusive, nontransferable, irrevocable, paid-up license
to practice, or have practiced, the invention throughout the world by or on
behalf of the US Government. 

            6.04
Government Contractor Inventions. In accordance with 37 Code of Federal
Regulations 401.14, if one of Laboratory’s Contractors conceives an invention
while performing services at Laboratory to fulfill Laboratory’s obligations
under this Agreement, Laboratory may require the Contractor to negotiate a
separate agreement with Cooperator regarding allocation of rights to any Subject
Invention the Contractor makes, solely or jointly, under this Agreement. The
separate agreement (i.e., between the Cooperator and the Contractor) shall be
negotiated prior to the Contractor undertaking work under this Agreement or,
with the Laboratory’s permission, upon the identification of a Subject
Invention. In the absence of such a separate agreement, the Contractor agrees to
grant the Cooperator an option for a license in Contractor’s inventions of the
same scope and terms set forth in this Agreement for inventions made by
Laboratory employees.

            6.05
Filing of Patent Applications. The party having the right to retain title
to, and file patent applications on, a specific Subject Invention may elect not
to file patent applications, provided it so advises the other party within 90
days from the date it reports the Subject Invention to the other party.
Thereafter, the other party may elect to file patent applications on the Subject
Invention and the party initially reporting the Subject Invention agrees to
assign its ownership interest in the Subject Invention to the other party.

            6.06
Patent Expenses. The expenses attendant to the filing of patent
applications shall be borne by the party filing the patent application. Each
party shall provide the other party with copies of the patent applications it
files on any Subject Invention, along with the power to inspect and make copies
of all documents retained in the official patent application files by the
applicable patent office. The parties agree to reasonably cooperate with each
other in the preparation and filing of patent applications resulting from this
Agreement. 

            6.07
Acknowledgement of Statement of Work. Nothing contained in this Article 6
is intended to alter or modify the provisions of Section 4.02 of this CRADA
and/or the respective roles and responsibilities of the Laboratory and
Cooperator as set forth in the SOW. It is acknowledged that it is not the intent
or the expectation of the Parties that any Invention be Made pursuant to this
Agreement. 

	CRADA for PoNS Device 	4	Proprietary 

            Article
7 Exclusive License 

            7.00
Grant. The Laboratory agrees to grant to the Cooperator an exclusive
license in each US patent application, and patents issued thereon, covering a
Subject Invention, which is filed by the Laboratory subject to the reservation
of a nonexclusive, nontransferable, irrevocable, paid-up license to practice and
have practiced the Subject Invention on behalf of the United States.

            7.01
Exclusive License Terms. The Cooperator shall elect or decline to
exercise its right to acquire an exclusive license to any Subject Invention
within six months of being informed by the Laboratory of the Subject Invention.
The specific royalty rate and other terms of license shall be negotiated
promptly in good faith and in conformance with the laws of the United
States.

            Article
8 Background Patent(s) 

            8.00
Laboratory Background Patent(s). Laboratory has filed patent
application(s), or is the assignee of issued patent(s), listed below which
contain(s) claims that are related to research contemplated under this
Agreement. No license(s) to this/these patent applications or issue patents
is/are granted under this Agreement, and this/these application(s) and any
continuations to it/them are specifically excluded from the definitions of
“Subject Invention” contained in this Agreement: None. 

            8.01
Cooperator Background Patent(s). Background Patent Owners warrant that
they retain title to the patent application listed below, which contains claims
that are related to research contemplated under this Agreement, such ownership
obtained in accordance with the terms of a letter agreement with the National
Institutes of Health, a fully executed copy of which will be provided to
Laboratory. No license(s) to this/these patent applications or issue patents
is/are granted under this Agreement, and this/these application(s) and any
continuations to it/them are specifically excluded from the definitions of
“Subject Invention” contained in this Agreement: 

            “Non-invasive
neuromodulation (NINM) for rehabilitation of brain function,” U.S. Patent
Application number 12/348,301, filed 04 Jan 2009, by co-inventors Yuri P.
Danilov, Mitchell E. Tyler, and Kurt A. Kaczmarek (collectively, Background
Patent Owners). This patent application is licensed by the Background Patent
Owners exclusively to Advanced NeuroRehabilitation, LLC, Madison, WI, which
intends to license the patent application exclusively to Cooperator.

            Article
9 Subject Data and Proprietary Information 

            9.00
Subject Data Ownership. Subject Data shall be jointly owned by the
parties. Each party, upon request to the other party, shall have the right to
review and to request delivery of all Subject Data, and delivery shall be made
to the requesting party within two weeks of the request, except to the extent
that such Subject Data are subject to a claim of confidentiality or privilege by
a third party. If this Agreement is terminated, each Party agrees to provide the
other with complete copies of all Subject Data within its possession.

            9.01
Proprietary Information/Confidential Information. Each party shall place
a proprietary notice on all information it delivers to the other party under
this Agreement that it asserts is proprietary. The parties agree that any
Proprietary Information or Confidential Information furnished by one party to
the other party under this Agreement, or in contemplation of this Agreement,
shall be used, reproduced and disclosed by the receiving party only for the
purpose of carrying out this Agreement, which expressly includes clinical and
commercial development of the PoNSTM, and shall not be released by
the receiving party to third parties unless consent to such release is obtained
from the providing party.

            9.02
Army Limited-Access Database. Notwithstanding anything to the contrary in
this Article, the existence of established CRADAs specifying areas of research
and their total dollar amounts may be documented on limited access,
password-protected websites of the US Army Medical Research and Materiel Command
(the parent organization of Laboratory), to provide the Command’s leadership
with a complete picture of military research efforts.

	CRADA for PoNS Device 	5	Proprietary 

            9.03
Laboratory Contractors. Cooperator acknowledges and agrees to allow
Laboratory’s disclosure of Cooperator’s proprietary information to Laboratory’s
Contractors for the purposes of carrying out this Agreement. Laboratory agrees
that it has or will ensure that its Contractors are under written obligation not
to disclose Cooperator’s proprietary information, except as required by law or
court order (in which case the Laboratory shall give sufficient notice to
Cooperator of any such application for a court order in order for Cooperator to
take such steps as necessary to file opposition to such application), before
Contractor employees have access to Cooperator’s proprietary information under
this Agreement. 

            9.04
Release Restrictions. Laboratory shall have the right to use all Subject
Data for any Governmental purpose, but shall not release Subject Data publicly
except: (i) Laboratory in reporting on the results of research may publish
Subject Data in technical articles and other documents to the extent it
determines to be appropriate; and (ii) Laboratory may release Subject Data where
release is required by law or court order. The parties agree to confer prior to
the publication of Subject Data to assure that no Proprietary Information is
released and that patent rights are not jeopardized. Prior to submitting a
manuscript for review which contains the results of the research under this
Agreement, or prior to publication if no such review is made, each party shall
be offered an ample opportunity to review any proposed manuscript and to file
patent applications in a timely manner. 

            All
publications will be provided to the Laboratory for review and sent to the US
Army Medical Research and Materiel Command’s Public Affairs Office (PAO) for
review and approval prior to use or release. Per USAMRMC regulation, such PAO
review will include operational security (OPSEC) review. 

            9.05
Public Affairs. As this work is or may have a high visibility, it is
important that the same message be delivered to all stakeholders, including the
public. Therefore, the parties agree that all releases of information related to
this CRADA, to include press releases, shall be reviewed and approved by the
USAMRMC PAO prior to release. 

            9.06
FDA Regulatory Matters. This Agreement involves a product subject to
regulation by the U.S. Food and Drug Administration (FDA) for which FDA
clearance or approval will be sought. Accordingly, the parties agree on the
provisions described in Appendix B. 

            Article
10 Termination 

            10.00
Termination by Mutual Consent. Cooperator and Laboratory may elect to
terminate this Agreement, or portions thereof, at any time by mutual consent.

            10.01
Termination by Unilateral Action. Either party may unilaterally terminate
this entire Agreement at any time by giving the other party written notice, not
less than 30 days prior to the desired termination date. 

            10.02
Termination Procedures. In the event of termination, the parties shall
specify the disposition of all property, patents and other results of work
accomplished or in progress, arising from or performed under this Agreement by
written notice. Upon receipt of a written termination notice, the parties shall
not make any new commitments and shall, to the extent feasible, cancel all
outstanding commitments that relate to this Agreement. Notwithstanding any other
provision of this Agreement, any exclusive license entered into by the parties
relating to this Agreement shall be simultaneously terminated unless the parties
agree to retain such exclusive license. 

            Article
11 Disputes 

            11.00
Settlement. Any dispute arising under this Agreement which is not
disposed of by agreement of the principal investigators shall be submitted
jointly to the signatories of this Agreement. A joint decision of the
signatories or their designees shall be the disposition of such dispute,
however; nothing in this section shall prevent any party from pursuing any and
all administrative and/or judicial remedies which may be allowable. 

	CRADA for PoNS Device 	6	Proprietary 

            Article
12 Liability 

            12.00
Property. Except for a breach of the confidentiality provisions of
Article 9, neither party shall be responsible for damages to any property
provided to, or acquired by, the other party pursuant to this Agreement. 

            12.01
Cooperator's Employees. Cooperator agrees to indemnify and hold harmless
the US Government for liability of any kind involving an employee of Cooperator
arising in connection with this Agreement, and for all liabilities arising out
of the use by Cooperator of Laboratory's research and technical developments, or
out of any use, sale or other disposition by Cooperator of products made based
on Laboratory's technical developments, except to the extent the liability is
due to the negligence of Laboratory and actionable under the provisions of the
Federal Tort Claims Act. This provision shall survive termination or expiration
of this Agreement. 

            12.02
No Warranty. The parties make no express or implied warranty as to any
matter whatsoever, including the conditions of the research or any Invention or
product, whether tangible or intangible, Made, or developed under this
agreement, or the ownership, merchantability, or fitness for a particular
purpose of the research or any Invention or product. 

            Article
13 Miscellaneous 

            13.00
Governing Law. The construction, validity, performance, and effect of
this Agreement shall be governed for all purposes by the laws applicable to the
United States Government.

            13.01
Export Control and Biological Select Agents and Toxins. The obligations
of the parties to transfer technology to one or more other parties, provide
technical information and reports to one or more other parties, and otherwise
perform under this Agreement are contingent upon compliance with applicable
United States export control laws and regulations. The transfer of certain
technical data and commodities may require a license from a cognizant agency of
the United States Government or written assurances by the Parties that the
Parties shall not export technical data, computer software, or certain
commodities to specified foreign countries without prior approval of an
appropriate agency of the United States Government. The Parties do not, alone or
collectively, represent that a license shall not be required, nor that, if
required, it shall be issued. In addition, where applicable, the parties agree
to fully comply with all laws, regulations, and guidelines governing biological
select agents and toxins. 

            13.02
Independent Contractors. The relationship of the parties to this
Agreement is that of independent contractors and not as agents of each other or
as joint venturers or partners. 

            13.03
Use of Name or Endorsements. (a) The parties shall not use the name of
the other party on any product or service which is directly or indirectly
related to either this Agreement or any patent license or assignment agreement
which implements this Agreement without the prior approval of the other party.
(b) By entering into this Agreement, Laboratory does not directly or indirectly
endorse any product or service provided, or to be provided, by Cooperator, its
successors, assignees, or licensees. Cooperator shall not in any way imply that
this Agreement is an endorsement of any such product or service. Press releases
or other public releases of information shall be coordinated between the parties
prior to release, except that the Laboratory may release the name of the
Cooperator and the title of the research without prior approval from the
Cooperator. 

            13.04
Survival of Specified Provisions. The rights specified in the following
sections of this Agreement shall survive termination or expiration hereof:

	 	i. 	
      3.04

	 	ii. 	
      5.03

	 	iii. 	
      5.04

	 	iv. 	
      Article 6

	 	v. 	
      7.00

	 	vi. 	
      9.00

	 	 	 

	CRADA for PoNS Device 	7	Proprietary 

	 	vii. 	
      9.03

	 	viii. 	
      9.04

	 	ix. 	
      Article 12

	 	x. 	
      Appendix B

            13.05
Notices. All notices pertaining to or required by this Agreement shall be
in writing and shall be signed by an authorized representative addressed as
follows: 

	 	If to Cooperator: 	
	 	 	Philippe Deschamps 
	 	 	208 Palmer Alley 
	 	 	Newtown, PA 18940 
	 	 	Phone: 614-596-2597 
	 	 	Email: pdeschamps409@gmail.com 
	 	 	  
	 	If to Laboratory: 	
	 	 	Michael Husband 
	 	 	Acute Care Division 
	 	 	Program Management Office Medical Devices
      USAMMA 
	 	 	693 Neiman Street 
	 	 	Fort Detrick, MD 21702 

            Any
party may change such address by notice given to the other in the manner set
forth above. 

            Article
14 Duration of Agreement and Effective Date 

            14.00
Effective Date. This Agreement shall enter into force as of the date it
is signed by the last authorized representative of the parties.

            14.01
Signature Execution. This Agreement may be executed in one or more
counterparts by the parties by signature of a person having authority to bind
the party, which may be by facsimile signature, each of which when executed and
delivered, by facsimile transmission, mail, or email delivery, will be an
original and all of which will constitute but one and the same Agreement.

            14.02
Expiration Date. This Agreement will automatically expire on December 31,
2015 unless it is revised by written notice and mutual agreement. 

[Signature Page Follows] 

	CRADA for PoNS Device 	8	Proprietary 

 

APPENDIX A 

STATEMENT OF WORK 

I. Title: Collaboration to advance the Portable
Neuromodulation Stimulator (PoNSTM) device through FDA approval for assisted
physical therapy in the treatment of soldiers and others with balance and gait
disorder.

II. Background: Current treatment methods for treating
balance disorders typically involve medication and various forms of vestibular
rehabilitation and physical therapy. Cooperator has developed a novel approach
to rehabilitating the injured or diseased human brain using cranial nerve
non-invasive neuromodulation (CN-NINM). Sustained application of this
stimulation, in conjunction with exercises targeted on a functional deficit,
appears to effect changes in activity, and therefore function, of these targeted
brain structures. CN-NINM has been tested on subjects having balance, posture
and gait disorders due to vestibular, cerebellar, or brainstem trauma. When
applied in conjunction with other therapeutic interventions for sensory and
movement control, integrating CN-NINM has been demonstrated to create localized
functional changes in brain activity levels which, along with observed
improvements in balance, posture, gait and limb movement control, provides
evidence of functional neurorehabilitation.

Many soldiers in the Armed Forces suffer from balance and gait
disorders subsequent to brain trauma from combat or other etiologies.
Neuromodulation stimulation with the PoNSTM has been shown to aid in
speeding up or increasing response to physical therapy in the treatment of
vestibular disorder. The PoNSTM is presently an experimental device that has been
successfully used in investigatory studies of human subjects with movement
disorders. Further testing and design development are required to facilitate
regulatory approval by the FDA and to meet the product requirements of its
eventual end users. An efficiently mass produced PoNSTM that suffers
no decreased functionality or reliability could allow patients to regain normal
activity in their civilian life, and for some, could allow them to return more
quickly to their duty station or military mission.

The goal of this Agreement is to investigate, through the means
of a blinded, well-designed study, to determine if the PoNSTM can be
mass produced and deployed in a prototypical clinical setting without suffering
any decreased functionality or reliability, and demonstrating safety and
efficacy in a registrational clinical trial.

Related background intellectual property includes the
trademark, PoNSTM, a pending U.S. patent application as cited in Article 8.01,
the current PoNSTM prototype design, and proprietary physical therapy protocols
developed by scientists at the University of Wisconsin at Madison.

III. Collaboration: 

	 	A. 	
      Subject to the availability of government funds to cover
      Laboratory costs, Laboratory agrees to:

	 	1. 	
      Serve as the Regulatory Sponsor of the PoNSTM for all
      formal and informal interactions with the FDA necessary to gain FDA
      clearance/approval, to include the initial 513(g) submission.

	 	2. 	
      Supply the facilities and personnel to execute and/or
      oversee the execution of clinical studies of the device for FDA
      clearance/approval in support of an intended use of the PoNSTM for the
      treatment of soldiers suffering from balance and gait
  disorders.

	 	i. 	
      Provide clinical trial monitoring

	 	ii. 	
      Provide full biostatical support

	 	iii. 	
      Provide data management oversight

	 	iv. 	
      Provide product technical oversight

	 	v. 	
      Provide safety pharmacovigilance and reporting to
    FDA

	 	vi. 	
      Device
qualification/validation;

	 	 	 

	CRADA for PoNS Device 	10	Proprietary 

	 	vii. 	
      Testing plan for release of
devices;

	 	3. 	
      Conduct assessments of manufacturing facility and
      assist/advise facility in meeting FDA manufacturing
requirements.

	 	4. 	
      Aid in designing the clinical protocols to study the
      PoNSTM device as an adjunct to specialized physical therapy in patients
      with balance and gait disorders.

	 	5. 	
      Provide advice and expertise on all Army administrative
      protocols and approvals to execute the studies with military personnel,
      reservists, and/or veterans.

	 	6. 	
      Prepare and submit the necessary regulatory filings for
      FDA to secure regulatory clearance or approval, after which such
      clearance/approval will be transferred to Cooperator.

	 	7. 	
      Ensure Cooperator receives copies of all formal and
      informal communications with

	 		
      FDA related to the PoNSTM
device.

	 	B. 	
      Subject to the availability of funds to cover Cooperator
      costs, Cooperator agrees to:

	 	1. 	
      Complete the commercial design, including ergonomics
      (e.g. user controls, comfort), and design for improved manufacturability,
      reliability, and field support and regulatory testing to comply with the
      FDA regulations for such devices.

	 	2. 	
      Work collaboratively with the Laboratory and other Army
      personnel to supply all the technical specifications, documentation and
      any other information required to address FDA requests on the pathway to
      obtaining FDA clearance/approval of the

	 		
      PoNSTM device.

	 	3. 	
      Finalize the commercial design of the PoNSTM device so
      that the devices would be commercially available to the Army should the
      results of the study be positive.

	 	4. 	
      Identify and engage a commercial manufacturer post-FDA
      clearance of the device to produce the device for purchase of the
      Government.

	 	5. 	
      Provide expertise and training in the design of clinical
      study protocols.

	 	6. 	
      Provide expertise and training of Army and/or Veterans
      Affairs personnel in the physical therapy interventions required for
      clinical studies.

This SOW may be adjusted by the parties in accordance with
Article 3.03 of the Agreement.

	CRADA for PoNS Device 	11	Proprietary 

APPENDIX B 

GOVERNMENT RIGHTS TO ENSURE PRODUCT AVAILABILITY 

This Appendix B only applies in the event that Cooperator is
not able or willing to commercialize the subject technology within a reasonable
period of time as defined herein from the expiration or termination of the
CRADA.

The terms “Regulatory Application” and “sponsor” and
“applicant” are used herein as defined in 2.04 of this Agreement. The term
“subject technology” is used herein to mean the PoNSTM technology as described
U.S. Patent Application number 12/348,301 as well as any improvements or
modifications developed during the term of this CRADA.

The parties to this CRADA further agree as follows:

	 	1. 	
      USAMRMC will be the sponsor of the Regulatory Application
      described in this Agreement until said application is cleared or approved
      by the FDA, at which point USAMRMC will transfer such clearance or
      approval to Cooperator.

	 	 	 
	 	2. 	
      During USAMRMC sponsorship, Laboratory will provide
      Cooperator, upon request, all communication, both formal and informal, to
      or from the FDA regarding the subject technology being developed under
      this CRADA. In addition, Laboratory will ensure that Cooperator staff are
      permitted the opportunity to participate in any sponsor meetings, both
      formal and informal, in which the subject technology is discussed with the
      FDA.

	 	 	 
	 	3. 	
      After any transfer of the Regulatory Application from
      USAMRMC to Cooperator, and in the event that Cooperator fails to obtain
      any additional, required FDA approval or clearance or to satisfy any
      outstanding regulatory requirement due from the sponsor within two (2)
      years after the expiration or termination of this CRADA, or where the
      Cooperator fails to commercially market the regulated technology to the
      point where the US Government may purchase the technology within two (2)
      years after the expiration or termination of this CRADA, Cooperator
      will:

	 	a. 	
      transfer possession, ownership and sponsorship/holdership
      of any Regulatory Application, regulatory correspondence, and supporting
      regulatory information related to the subject technology to
  USAMRMC;

	 	 	 
	 	b. 	
      inform FDA of the transfer of sponsorship or holdership
      of the Regulatory Application transferred under section 3a above;
    and

	 	 	 
	 	c. 	
      provide the U.S. Government with a non-exclusive,
      paid-up, irrevocable license to any patent, copyright, data rights,
      proprietary information (as defined in section 2.03) or regulatory
      information held by the Cooperator, or obtained from the Cooperator by a
      third party, in order to permit the U.S. Government to pursue
      commercialization of the subject technology.

	 	 	 

	CRADA for PoNS Device 	12	Proprietary 

 

 

NOTICE OF MODIFICATION No. 2

  of 

  COOPERATIVE RESEARCH AND
  DEVELOPMENT AGREEMENT 

  between 

US Army Medical Materiel Agency (USAMMA) 

  a
  subordinate activity of the US Army Medical Research and Materiel Command
  (USAMRMC), in

  collaboration with the Combat Casualty Care Research Program
  (CCCRP) 

and 

US Army Medical Materiel Development Activity (USAMMDA) 

  (USAMMA and USAMMDA collectively as Laboratory) 

and 

NeuroHabilitation Corporation (Cooperator) 

    Yuri P.
      Danilov, Mitchell E. Tyler, Kurt A. Kaczmarek (Background Patent Owners) 

  Advanced NeuroRehabilitation, LLC (Exclusive Licensee of Background
  Patent) 

        
     The United States Army Medical Materiel Agency, 693
  Neiman St. Fort Detrick, Maryland 21702-5012, U.S.A.; United States Army
    Medical Materiel Development Activity, 1430 Veterans Drive, Fort Detrick,
  Maryland 21702-5012, U.S.A. and NeuroHabilitation Corporation 208 Palmer
  Alley, Newtown, PA 18940, entered into a Cooperative Research and Development
  Agreement ("Agreement") (U.S. Army Medical Research and Materiel Command Control
  Number W81XWH-13-0145) on 1 February 2013, for research and development on
  "Collaboration to advance the Portable Neuromodulation Stimulator (PoNSTM) device
  through FDA approval for assisted physical therapy in the treatment of soldiers
  and others with balance and gait disorder." 

       
      The Parties agree that a modification is required to the
  agreement to better align with current objectives of the collaboration.

Now, the Parties desire to amend the Agreement as follows: 

	 	•	Appendix A. Section III A and B are changed to reflect
      the following:

	 	 	 	 
	 		o
	The role of Regulatory Sponsor and executor of
      FDA-regulated studies in the pursuit of the original indication sought
      under this agreement (balance and gait disorder) has been shifted from the
      Laboratory to the Cooperator;

	 	 	 	 
	 		o
	The original indication (balance and gait disorder) is
      removed from the Statement of Work and replaced with "military relevant
      neurological disorders, including but not limited to Tinnitus, PTSD, pain
      and any subsequent indications identified by the parties";

	 	 	 	 
	 		o
	The Cooperator will be the Regulatory Sponsor for all
      future indications governed by this CRADA;

	 	 	 	 
	 		o
	The Laboratory will be responsible for supporting the
      execution of studies using the PoNS device as a treatment for mutually
      agreed-upon military relevant neurological disorders, including but not
      limited to Tinnitus, PTSD, pain and any subsequent indications identified
      by the parties; and

	 	 	 	 
	 		o
	The Cooperator will be responsible for the supply of
      devices in support of mutually agreed upon studies governed by this
      CRADA.

	USAMMA- PoNSTM CRADA NOM 1_5 DEC 2013 	Page 1 of 3 

	 	•
	Appendix B.

	 	 	 	 
	 		o
	Appendix B applies for any mutually agreed-upon
      military-relevant neurological disorders governed by the CRADA. Once the
      parties have mutually agreed that a neurological disorder is military
      relevant, as documented in any written communication between the parties,
      the terms and conditions of Appendix B apply and cannot be unilaterally
      modified or unilaterally rescinded;

	 	 	 	 
	 		o
	Section 1 is modified for reflect the role of FDA sponsor
      is the responsibility of the Cooperator;

	 	 	 	 
	 		o
	Section 2 is modified to require all FDA communication to
      be shared with Laboratory;

	 	 		 
	 		o
	Section 3 is modified to extend from two (2) to four (4)
      years the time for Cooperator to obtain final regulatory approval or
      clearance. This extension to four (4) years is only in the event that a
      pre-market approval application (PMA) is required for the following PoNS
      indication: "aid to therapy for chronic balance deficits resulting from
      mild to moderate TBI." This clause remains unchanged as it relates to
      other indications governed by this agreement.

	 	 	 	 
	 		o
	Section 3 is modified to extend from two (2) to four (4)
      years the timeframe for commercialization of the product. This clause
      remains unchanged as it relates to other indications governed by this
      agreement.

All other provisions of this Agreement, as previously amended,
  are unchanged. 

  IN WITNESS WHEREOF, the Parties have caused this modification
  to be executed by their duly authorized representatives as follows: 

For the Cooperator: 

	 	/s/ Philippe
      Deschamps                                           
       	DATE 	  
      12/22/2014                                
	 	Philippe Deschamps 	 	 
	 	Chief Operating Officer 	 	 
	 	NeuroHabilitation Corporation 	 	 

For Advanced NeuroRehabilitation, LLC and as Background Patent
  Owners: 

	 	/s/ Yuri P.
      Danilov                                                      	DATE 	   26 DEC
      2014                            
	 	Yuri P. Danilov 	 	 
	 	 	 	 
	 	 	 	 
	 	/s/ Mitchell E.
      Tyler                                                
       	DATE 	   22 DEC 2014
                                 
	 	Mitchell E. Tyler 	 	 
	 	 	 	 
	 	 	 	 
	 	/s/ Kurt A.
      Kaczmarek                               
                     	DATE 	   26 DEC
      2014                            
	 	Kurt A. Kaczmarek 	 	 

For the US Government USAMMA: 

	 	/s/ David
      Gibson                                                        	DATE	                                                 
	 	Colonel, Medical Service Corps 	 	 
	 	Commander, U.S. Army Medical Materiel Agency 	 	 

 

	USAMMA- PoNSTM CRADA NOM 1_5 DEC 2013 	Page 2 of 3 

For the US Government USAMMDA: 

	 	/s/ Stephen J.
      Dalal                                                         	DATE 	    12 JAN
      15                             
       
	 	Stephen J. Dalal 	 	 
	 	Colonel, Medical Service Corps 	 	 
	 	Commander, U.S. Army Medical Materiel Development Agency 	 	 

	USAMMA- PoNSTM CRADA NOM 1_5 DEC 2013 	Page 3 of 3

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