Helius Medical Technologies, Inc. - Exhibit 10.1 - Filed by newsfilecorp.com







 





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SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES 

SECTION A - SOLICITATION/CONTRACT FORM

The following have been
modified:
       ADDITIONAL INFORMATION

ADDITIONAL INFORMATION 


PROJECT TITLE: Development and U.S. Food and Drug
Administration (FDA) Clearance of the Portable Neuromodulation Stimulator
(PoNSTM) 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 Kelly Green at
USAMRAA, ATTN: Kelly Green, MRMC-AAA-SD, 820 Chandler Street, Fort Detrick, MD
21702-5014 or kelly.r.green.civ@mail.mil or
301-619-1346.

The Contracting Officer’s Representative for this contract is
Brian Dacanay at USAMMA, ATTN: Brian Dacanay, 693 Neiman Street, Fort Detrick,
MD 21702 or Brian.i.dacanay.civ@mail.mil or
301-619-4348. 

 

SECTION C - DESCRIPTIONS AND SPECIFICATIONS

The following have been
modified:
       PERFORMANCE WORK
STATEMENT 
Revised PWS – Mod P00001 


a) Section 1.1. Changed (TBI) to (mTBI).
b)
Section 1.3. Changed eighteen (18) to thirty (30) 
c) Section 1.3.
Changed the Period of Performance from 01 July 2015 – 31 December 2016 to 01
July 2015 – 31 December 2017.
d) Revised Sections 1.3. and
3.1.4.
e) Added “and when additional sites are added” in the Initial
and Subsequent column of the deliverable table for deliverables 6 – 14.


 

PERFORMANCE WORK STATEMENT (PWS) 

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






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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 (mTBI). 

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.

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.




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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) thirty (30) month Base Period. The Period of Performance
breakdown reads as follows: 


	Base Period 	01 July 2015 – 31 December 2017    



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. 

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.




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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). 

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. The Contractor shall provide a
copy of the IRB-approved clinical study protocol and informed consent form for
any additional study site. 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 any additional
study site (CDRL A003 / QASP #2).




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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 provide the COR with documentation of appropriate IRB approvals from any
additional study site, institute, and Army, as required. 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). 

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). 




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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). 

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. 




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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 and when additional sites are added. 
	7 	3.1.3. 	Statistical Analysis Plan (CDRL A003) 	COR 	1 	Within 3 months of award of
      contract and when additional sites are added. 
	8 	3.1.3. 	Clinical Monitoring Plan (CDRL A003) 	COR 	1 	Within 3 months of award of
      contract and when additional sites are added. 
	9 	3.1.3. 	Data Management Plan (CDRL A003) 	COR 	1 	Within 3 months of award of
      contract and when additional sites are added. 
	10 	3.1.3. 	Proposed Clinical Data Management System (CDRL
      A003) 	COR 	1 	Within 3 months of award of
      contract and when additional sites are added. 
	11 	3.1.3. 	Sample Case Report Forms (CDRL A003) 	COR 	1 	Within 3 months of award of
      contract and when additional sites are added. 
	12 	3.1.3. 	End User Guidelines (CDRL A003) 	COR 	1 	Within 3 months of award of
      contract and when additional sites are added. 
	13 	3.1.3. 	Recruitment and Retention Plan for each
      Clinical Site (CDRL A003) 	COR 	1 	Within 3 months of award of
      contract and when additional sites are added. 
	14 	3.1.4. 	IRB Approvals (CDRL A004) 	COR 	1 	Within 3 months of award of
      contract and prior to start of clinical trial and when additional sites
      are added. 
	15 	3.1.5. 	Representative Test Articles (sent to 	COR 	1 	Prior to start of clinical trial    







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	Item 	PWS Ref 	Title 	Distribution 	E 	Initial & Subsequent    
	  	  	study sites) (CDRL A005) 	  	  	  
	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.) 
	30 	3.5.5. 	Trip Reports 	COR 	1 	Within 5 business days for
      Government requested travel 



5. List of Acronyms: 




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	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 


SECTION F - DELIVERIES OR PERFORMANCE

The following Delivery Schedule item for CLIN 0001 has been
changed from: 

	 	DELIVERY DATE 	QUANTITY 	SHIP TO ADDRESS 	DODAAC 
	 	  	  	  	  
	 	POP 01-JUL-2015 TO 	N/A 	US ARMY MEDICAL MATERIEL AGENCY W25MWY 
	 	31-DEC-2016 	  	US ARMY MEDICAL MATERIEL AGENCY 
	 	  	  	693 NEIMAN STREET 	  
	 	  	  	FREDERICK MD 21702 	  
	 	  	  	301-619-4518 	  
	 	  	  	FOB: Destination 	  







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To: 

	 	DELIVERY DATE 	QUANTITY 	SHIP TO ADDRESS 	DODAAC 
	 	  	  	  	  
	 	POP 01-JUL-2015 TO 	N/A 	US ARMY MEDICAL MATERIEL AGENCY W25MWY 
	 	31-DEC-2017 	  	US ARMY MEDICAL MATERIEL AGENCY 
	 	  	  	693 NEIMAN STREET 	  
	 	  	  	FREDERICK MD 21702 	  
	 	  	  	301-619-4518 	  
	 	  	  	FOB: Destination 	  


The following Delivery Schedule item for CLIN 0002 has been
changed from: 

	 	DELIVERY DATE 	QUANTITY 	SHIP TO ADDRESS 	DODAAC 
	 	  	  	  	  
	 	POP 01-JUL-2015 TO 	N/A 	US ARMY MEDICAL MATERIEL AGENCY W25MWY 
	 	30-DEC-2016 	  	US ARMY MEDICAL MATERIEL AGENCY 
	 	  	  	693 NEIMAN STREET 	  
	 	  	  	FREDERICK MD 21702 	  
	 	  	  	301-619-4518 	  
	 	  	  	FOB: Destination 	  


To: 

	 	DELIVERY DATE 	QUANTITY 	SHIP TO ADDRESS 	DODAAC 
	 	  	  	  	  
	 	POP 01-JUL-2015 TO 	N/A 	US ARMY MEDICAL MATERIEL AGENCY W25MWY 
	 	31-DEC-2017 	  	US ARMY MEDICAL MATERIEL AGENCY 
	 	  	  	693 NEIMAN STREET 	  
	 	  	  	FREDERICK MD 21702 	  
	 	  	  	301-619-4518 	  
	 	  	  	FOB: Destination 	  


The following Delivery Schedule item for CLIN 0003 has been
changed from: 

	 	DELIVERY DATE 	QUANTITY 	SHIP TO ADDRESS 	DODAAC 
	 	  	  	  	  
	 	POP 01-JUL-2015 TO 	N/A 	US ARMY MEDICAL MATERIEL AGENCY W25MWY 
	 	30-DEC-2016 	  	US ARMY MEDICAL MATERIEL AGENCY 
	 	  	  	693 NEIMAN STREET 	  
	 	  	  	FREDERICK MD 21702 	  
	 	  	  	301-619-4518 	  
	 	  	  	FOB: Destination 	  


To: 

	 	DELIVERY DATE 	QUANTITY 	SHIP TO ADDRESS 	DODAAC 






W81XWH-15-C-0096 
P00001 
Page 12 of 14 


	 	POP 01-JUL-2015 TO 	N/A 	US ARMY MEDICAL MATERIEL AGENCY W25MWY 
	 	31-DEC-2017 	  	US ARMY MEDICAL MATERIEL AGENCY 
	 	  	  	693 NEIMAN STREET 
	 	  	  	FREDERICK MD 21702 
	 	  	  	301-619-4518 
	 	  	  	FOB: Destination 


SECTION G - CONTRACT ADMINISTRATION DATA

 

The following have been added by full text:

          MODIFIED
PAYMENT SCHEDULE 

Modified Payment Schedule for subject completion and delivery
of two (2) FDA cleared devices. CLIN 0003 – Other Direct Costs (ODCs) for travel
expenses is excluded from this modified payment schedule.

Payment 1: The NeuroHabilitation Corporation (NHC) may invoice
CLIN 0001 for $2,807.49 and CLIN 0002 for $229,795.42 upon the completion of 30
subjects. 

Payment 2: NHC may invoice CLIN 0001 for $2,807.49 and CLIN
0002 for $229,795.42 upon the completion of 60 subjects. 

Payment 3: NHC may invoice CLIN 0001 for $2,807.49 and CLIN
0002 for $229,795.42 upon the completion of 90 subjects. 

Payment 4: NHC may invoice CLIN 0001 for $2,807.49 and CLIN
0002 for $229,795.42 upon the completion of 120 subjects. 

Payment 5: NHC may invoice CLIN 0001 for $2,807.52 and CLIN
0002 for $229,795.43 once two (2) FDA cleared devices are delivered to the U.S.
Army Medical Materiel Agency (USAMMA).

 

 

The following have been modified:

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. 




W81XWH-15-C-0096 
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(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) 

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

Not Applicable 

(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) 	HAA391 
	Accept at Other DoDAAC 	N/A 
	LPO DoDAAC 	N/A 
	DCAA Auditor DoDAAC 	HAA391 
	Other DoDAAC(s) 	N/A 
	--------------------------------------------------------------------------------------------    



(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. 




W81XWH-15-C-0096 
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(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. 

Brian.i.dacanay.civ@mail.mil 

(g) WAWF point of contact. (1) The Contractor may obtain
clarification regarding invoicing in WAWF from the following contracting
activity's WAWF point of contact. 

Brian.i.dacanay.civ@mail.mil 

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

(End of clause) 

(End of Summary of Changes)