Helius 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