Document:

Exhibit 10.3

 

EMPLOYMENT AGREEMENT 

 

 

EMPLOYMENT AGREEMENT (this
“Agreement”) dated as of February 15, 2021 between DAVID OWENS, MD (the “Executive”) and NEXALIN
TECHNOLOGY INC. (the “Company”).

 

WHEREAS, the Company would
like to employ the Executive as its Chief Medical Officer; and

 

WHEREAS, the Company and
the Executive desire to provide for the terms and conditions of the future employment of the Executive by the Company.

 

NOW, THEREFORE,
in consideration of the premises and covenants herein contained, the parties hereto agree as follows:

 

1.          Employment
Term. Subject to the terms and conditions hereof, the Company employs the Executive and the Executive accepts such employment for
the three (3) year period commencing on February 15, 2021 and ending on February 14, 2024 (the “Employment Term”),
with an option for the Company and the Executive to extend the term for an additional two (2) year period no later than sixty (60) days
prior to the expiration of the initial Employment Term.

 

3.          Duties
and Responsibilities. During the Employment Term, the Executive shall serve as the Chief Medical Officer of the Company and as the
holder of such other senior executive positions consistent therewith as the Board may determine. He shall report to, and be subject to,
the direction of the Company’s Board of Directors with such duties and responsibilities as are commensurate with his title and position.
The Executive shall work on a full-time basis and shall devote his time, energy and attention to the business of the Company; it being
understood that Executive’s employment hereunder shall not preclude his working on other non-competitive business matters that do
not interfere with his duties hereunder. Due to the fact that the current amount of time required for the Executive to perform his services
is unknown as of the date hereof and may likely fluctuate during the Employment Term, a semi-annual written evaluation of this Agreement
will be performed jointly by the Company and the Executive and any modifications hereto may be mutually agreed to by the parties (including
approval by the Company’s Board of Directors).

 

4.          Compensation.

 

(a)        Basic
Compensation. In payment for services to be rendered by the Executive hereunder, the Executive shall be entitled to annual compensation
of $150,000, which shall be payable on January 15th of each calendar year during the Employment Term and shall be payable by the issuance
to the Executive of shares of common stock of the Company based upon the value of such shares as follows: (i) if the Company is publicly
traded, the average daily trading price of the Company’s shares over the prior 30 days, or (ii) if the Company is not publicly traded,
$0.20 per share based upon the most recent value of the Company’s shares in private sales transactions prior to the date hereof.

 

(b)        Bonus.
The Executive may be entitled to receive additional compensation based upon the successful achievement of certain mutually agreed upon
research and development “milestones.” Two milestones will be agreed upon each year by the parties (including approval by
the Company’s Board of Directors). The milestones for the year of 2021 include:

 

(i)         Evaluation
of new 15 mA digital waveform for safety; and

 

     

     

    

(ii)        Evaluation
of efficacy of the Company’s neurostimulation stimulation device in opioid use disorder management.

 

The total compensation for each milestone achieved
will be equal to $50,000 and shall be payable by the issuance to the Executive of shares of common stock of the Company based upon the
same valuation procedure as set forth above.

 

Additional milestones may be agreed upon at any time
between the Parties with compensation to be paid in an amount commensurate to the proposed Services for such milestones and will be compensated
in the award of Company stock as agreed by the Parties. There will be no limit to the number of milestones that can be proposed within
a twelve-month period.

 

(c)        Specified
Employee. If the Executive is a “specified employee” of the Company within the meaning of Section 409A(a)(2)(B)(i) of
the Internal Revenue Code (the “Code”) (or any successor provision), no payment under this Section 4 in connection with the
Executive’s termination of employment (other than a payment of salary through the date of such termination, and payments on account
of termination of employment by reason of death) shall be made until the date which is six (6) months after the date of the termination
of the employment of the Executive (or, if earlier, the date of death of the Executive); provided further, if the Company determines based
upon written advice of counsel that any such payment if made during the calendar year that includes the termination date would not be
deductible in whole or in part by reason of Code § 162(m), such payment shall be made on January 2 of the following calendar year
(or such later date as may be required under the preceding proviso if the Executive is a “specified employee”).

 

5.          Expenses.
During the Employment Term, the Executive shall be entitled to receive prompt reimbursement for all reasonable expenses incurred by
him (in accordance with the policies and procedures established from time to time by the Board of Directors of the Company) in performing
services hereunder, provided that such expenses are incurred and accounted for in accordance with the policies and procedures established
by the Company.

 

6.          Other
Benefits. The Executive shall be entitled to the following additional benefits:

 

(a)        two
(2) weeks of paid vacation during each year of the term; it being understood and agreed that Executive shall be entitled to take such
additional paid vacation time as does not interfere with the performance of his duties hereunder and as are not reasonably objected to
by the Company’s Board of Directors.

 

(b)        Paid
holidays in accordance with the Company’s usual holiday schedule.

 

(c)        Such
major medical and dental coverage benefits and long-term disability group plan coverage generally available to the Company's officers.
To the extent the Executive qualifies, the Executive may participate in, or benefit under, any employee benefit plan, arrangement or perquisite
made available by the Company to its key executives.

 

(d)        The
Company shall reimburse the Executive for such ordinary and necessary business-related expenses as shall be incurred by the Executive
in the course of the performance of his duties under this Agreement.

 

7.          Termination.
The Executive's employment hereunder may be terminated under the following circumstances:

 

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(a)        The
Company shall have the right to terminate the employment of the Executive under this Agreement for disability in the event the Executive
suffers an injury, or physical or mental illness or incapacity of such character as to substantially disable him from performing his duties
hereunder for a period of more than one hundred eighty (180) consecutive days upon the Company giving at last thirty (30) days written
notice of termination; provided, however, that if the Executive is eligible to receive disability payments pursuant to a disability insurance
policy or policies paid for by the Company, the Executive shall assign such benefits to the Company for all periods as to which he is
receiving payment under this Agreement.

 

(b)        This
Agreement shall terminate upon the death of Executive.

 

(c)        The
Company may terminate this Agreement at any time for “Cause” because of (i) his being convicted of criminal charges or violating
such rules and regulations of the Securities and Exchange Commission as may result in criminal action or material fines against the Company;
(ii) Executive’s material breach of any term of this Agreement; or (iii) the willful engaging by the Executive in misconduct which
is materially injurious to the Company, monetarily or otherwise; provided, in the case or (ii) or (iii), however, that the Company shall
not terminate this Agreement pursuant to this Section 7(c) unless the Company shall first have delivered to the Executive a notice which
specifically identifies such breach or misconduct, specifies reasonable corrective action and the Executive shall not have cured the breach
or corrected the misconduct within fifteen (15) days after receipt of such notice.

 

		(d)	The Executive may terminate his employment for “Good Reason” on five days written notice if:

 

		(i)	he is assigned, without his express written consent, any duties inconsistent
with his positions, duties, responsibilities, authority and status with the Company as of the date hereof, or a change in his reporting
responsibilities or titles as in effect as of the date hereof, except in connection with the termination of his employment by him without
Good Reason; or

 

		(ii)	his compensation is reduced.

 

 

(d)        Upon
termination of Executive’s employment by Executive or by the Company, for any reason or for no reason, Executive shall deliver promptly
to the Company all records, manuals, books, blank forms, documents, letters, memoranda, notes, notebooks, reports, data, tables, and calculations,
and copies thereof, in whatever medium, which are the property of the Company or its affiliates or which relate in any relevant, meaningful
way to the business, products, practices, techniques, customers, suppliers, functions or operations of the Company or its affiliates,
and all other property and Confidential Information of the Company or its affiliates, including, but not limited to, all documents which
in whole or in part contain any Confidential Information of the Company or its affiliates, which in any of these cases are in his possession
or under his control.

 

8.          Nondisclosure;
Noncompetition.

 

(a)        The
Executive agrees not to use or disclose, either while in the Company's employ or at any time thereafter, except with the prior written
consent of the Board of Directors, any trade secrets, proprietary information, or other information that the Company considers confidential
relating to processes, suppliers (including but not limited to a list or lists of suppliers), customers (including but not limited to
a list or lists of customers), compositions, improvements, inventions, operations, processing, marketing, distributing, selling, cost
and pricing data, or master files utilized by the Company, not

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presently generally known to the public, and which
is, obtained or acquired by the Executive while in the employ of the Company.

 

(b)        During
his employment and for a period of two years thereafter, the Executive shall not, directly or indirectly; (i) in any manner, engage in
any business which competes with any business conducted by the Company (including any subsidiary) and will not directly or indirectly
own, manage, operate, join, control or participate in the ownership, management, operation or control of, or be employed by or connected
in any manner with any corporation, firm or business that is so engaged (provided, however, that nothing herein shall prohibit the Executive
from owning not more than three percent (3%) of the outstanding stock of any publicly held corporation), (ii) persuade or attempt to persuade
any employee of the Company to leave the employ of the Company or to become employed by any other entity, or (iii) persuade or attempt
to persuade any current client or former client with leaving, or to reduce the amount of business it does or intends or anticipates doing
with the Company.

 

(c)       During his employment with
the Company, and for two years thereafter, the Executive shall not take any action which might divert from the Company any opportunity
learned about by him during his employment with the Company (including without limitation during the Employment Term) which would be within
the scope of any of the businesses then engaged in or planned to be engaged in by the Company.

 

(d)       In the event that this Agreement shall be terminated, then notwithstanding such termination, the obligations of the Executive pursuant
to this Section 8 of this Agreement shall survive such termination.

 

9.          Inventions.

 

(a)        The
Executive acknowledges and agrees that all ideas, methods, inventions, discoveries, improvements, work products, developments, software,
know-how, processes, techniques, methods, works of authorship and other work product, whether patentable or unpatentable, (A) that are
reduced to practice, created, invented, designed, developed, contributed to, or improved with the use of any Company resources and/or
within the scope of the Executive’s work with the Company or that relate to the business, operations or actual or demonstrably anticipated
research or development of the Company, and that are made or conceived by the Executive, solely or jointly with others, during his employment
with Company, or (B) suggested by any work that the Executive performs in connection with the Company, either while performing the Executive’s
duties with the Company or on the Executive’s own time, but only insofar as the Inventions are related to the Executive’s
work as an employee or other service provider to the Company, shall belong exclusively to the Company (or its designee), whether or not
patent or other applications for intellectual property protection are filed thereon (the “Inventions”). The Executive will
keep full and complete written records (the “Records”), in the manner prescribed by the Company, of all Inventions, and will
promptly disclose all Inventions completely and in writing to the Company. The Records shall be the sole and exclusive property of the
Company, and the Executive will surrender them upon the termination of his employment or upon the Company’s request. The Executive
irrevocably conveys, transfers and assigns to the Company the Inventions and all patents or other intellectual property rights that may
issue thereon in any and all countries, whether during or subsequent to his term of employment, together with the right to file, in the
Executive’s name or in the name of the Company (or its designee), applications for patents and equivalent rights (the “Applications”).
The Executive will, at any time during and subsequent to his term of employment, make such applications, sign such papers, take all rightful
oaths, and perform all other acts as may be requested from time to time by the Company to perfect, record, enforce, protect, patent or
register the Company’s rights in the Inventions, all without additional compensation to the Executive from the Company. The Executive
will also execute assignments to the Company (or its designee) of the Applications, and give the Company and its attorneys all reasonable
assistance (including the giving of testimony) to obtain the Inventions for the

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Company’s benefit, all without additional compensation
to the Executive from the Company, but entirely at the Company’s expense.

 

(b)        In
addition, the Inventions will be deemed Work for Hire, as such term is defined under the copyright laws of the United States, on behalf
of the Company and the Executive agrees that the Company will be the sole owner of the Inventions, and all underlying rights therein,
in all media now known or hereinafter devised, throughout the universe and in perpetuity without any further obligations to the Executive.
If the Inventions, or any portion thereof, are deemed not to be Work for Hire, or the rights in such Inventions do not otherwise automatically
vest in the Company, the Executive hereby irrevocably conveys, transfers and assigns to the Company, all rights, in all media now known
or hereinafter devised, throughout the universe and in perpetuity, in and to the Inventions, including, without limitation, all of the
Executive’s right, title and interest in the copyrights (and all renewals, revivals and extensions thereof) to the Inventions, including,
without limitation, all rights of any kind or any nature now or hereafter recognized, including, without limitation, the unrestricted
right to make modifications, adaptations and revisions to the Inventions, to exploit and allow others to exploit the Inventions and all
rights to sue at law or in equity for any infringement, or other unauthorized use or conduct in derogation of the Inventions, known or
unknown, prior to the date hereof, including, without limitation, the right to receive all proceeds and damages therefrom. In addition,
the Executive hereby waives any so-called “moral rights” with respect to the Inventions. To the extent that the Executive
has any rights in the results and proceeds of the Executive’s service to the Company that cannot be assigned in the manner described
herein, the Executive agrees to unconditionally waive the enforcement of such rights. The Executive hereby waives any and all currently
existing and future monetary rights in and to the Inventions and all patents and other registrations for intellectual property that may
issue thereon, including, without limitation, any rights that would otherwise accrue to the Executive’s benefit by virtue of the
Executive being an employee of or other service provider to the Company.

 

10.       Successors.
This agreement shall inure to the benefit of and be enforceable by the Executive's personal or legal representatives, executors, administrators,
successors, heirs, distributees, devisees and legatees. If the Executive should die while any amount would still be payable hereunder
if the Executive had continued to live, all such amounts, unless otherwise provided herein, shall be paid in accordance with the terms
of this Agreement to the Executive’s devisee, legatee or other designee or, if there be no such designee, to the Executive's estate.

 

11.       Amendment; Waiver.
No provisions of this Agreement may be modified, supplemented, waived or discharged unless such waiver, modification or discharge is agreed
to in a writing signed by the Executive and the Company. No waiver by either party hereto at any time of any breach by the other party
hereto of, or in compliance with, any condition or provision of this Agreement to be performed by such other party shall be deemed a waiver
of similar or dissimilar provisions or conditions at the same or at any prior or subsequent time. No agreements or representations, oral
or otherwise, express or implied, with respect to the subject matter hereof have been made by either party which are not set forth expressly
in this Agreement.

 

12.       Applicable Law. The
validity, interpretation, construction, and performance of this Agreement shall be governed by the laws of the State of Nevada without
regard to its conflict of laws principles.

 

13.       Severability of Covenants.
In the event that any provision of this Agreement, including any sentence, clause or part hereof, shall be deemed contrary to law or invalid
or unenforceable in any respect by a court of competent jurisdiction, the remaining provisions shall not be affected, but shall remain
in full force and effect and any invalid and enforceable provisions shall be deemed, without further action on

    5 

     

    

the part of the undersigned, modified, amended and
limited solely to the extent necessary to render the same valid and enforceable.

 

14.       Remedies.

 

(a)        In
the event of a breach or threatened breach of any of the Executive's covenants under Section 8, the Executive acknowledges that the Company
will not have an adequate remedy at law. Accordingly, in the event of any such breach or threatened breach, the Company will be entitled
to such equitable and injunctive relief as may be available to restrain the Executive from the violation of the provisions thereof.

 

(b)        Nothing
herein shall be construed as prohibiting the Company, on the one hand, and the Executive, on the other hand, from pursuing any remedies
available at law or in equity for any breach or threatened breach of the provisions of this Agreement by the other party, including the
recovery of damages.

 

(c)        If
the Company terminates this Agreement at any time without Cause (as defined above in Section 7(c)) or the Executive terminates his employment
for a Good Reason (as defined above in Section 7(d)), after the second anniversary of this Agreement, the Executive shall be entitled
under this Section 14(c) to receive an amount equal to the amount of the compensation payments that, but for his termination of employment,
would have been payable to the Executive under Section 4(a) for the remaining period of the Employment Term.

 

(d)        The
above amounts shall be deemed liquidated damages, and not a penalty. The Executive shall not be required to mitigate the amount of any
payment received pursuant to this paragraph nor shall the amount payable under this paragraph be reduced by any compensation earned by
the Executive after the date of his termination of employment.

 

15.       Notices. Any notice,
request, instruction or other document to be given hereunder by any party to the other party shall be in writing and shall be deemed to
have been duly given when delivered personally or five (5) days after dispatch by registered or certified mail, postage prepaid, return
receipt requested, to the party to whom the same is so given or made:

 

If to the Company

 

	 	addressed to:	Nexalin Technology Inc.
	 	 	1776 Yorktown 
	 	 	Suite 550 
	 	 	Houston, TX 77056
	 	 	Attention: 
	 	 	 
	 	with a copy to:	Warhsaw Burstein LLP
	 	 	575 Lexington Avenue
	 	 	New York, New York 10022
	 	 	Attention: Martin Siegel, Esq.
	 	 	 
	 	If to the Executive 	 
	 	 	 
	 	addressed to:	David Owens, MD
	 	 	4545 Harris Trail
	 	 	Atlanta, Georgia 30327

 

    6 

     

    

or to such other address as the one party shall specify
to the other party in writing.

 

16.       Entire Agreement. This
Agreement sets forth the entire agreement of the parties hereto in respect of the subject matter contained herein and supersedes all prior
agreements, promises, covenants, arrangements, communications, representations or warranties, whether oral or written, by any officer,
employee or representative of any party hereto; and any prior agreement of the parties hereto in respect of the subject matter contained
herein is hereby terminated and canceled.

 

IN WITNESS WHEREOF, the parties have executed
this Agreement on the date and year first above written.

 

	 	NEXALIN TECHNOLOGY INC.
	 	 
	 	 
	 	By: ___________________________
	 	Name:
	 	Title:          
	 	 
	 	 
	 	 
	 	_______________________________
	 	DAVID OWENS, MD 

 

 

    7Exhibit 10.4

NEX-CNT-00016

Revision
1

Apical
Quality Agreement

This Quality Agreement (“Agreement”)
is made on 12/21/2020by and between Nexalin and Apical Instruments (“Apical”).

 

		1	Introduction

The objectives of this Quality Assurance Agreement are to:

		•	establish a collaborative partnership

		•	define responsibilities

		•	assure that all quality requirements concerning the Nexalin Products are met

		•	ensure that operations between Apical and Nexalin run smoothly.

This Quality Assurance Agreement defines
the Quality relationship only and is supplementary to existing and future Agreements which describe the business Terms and Conditions.

 

		2	Scope

This Quality Assurance Agreement applies to all Nexalin
products.

 

		3	Quality Agreement

Nexalin is responsible for overall
compliance to applicable regulations. Apical will maintain the Nexalin Quality System, Design History File (DHF) and the Device Master
Record (DMR) for Nexalin.

Apical agrees to notify Nexalin’s
Quality prior to implementation of any changes to the purchased product such as materials used or configuration or site of manufacture.
This will allow Nexalin to determine the overall impact, if any, of the changes to Nexalin’s product.

Nexalin will qualify and approve Apical by use of one of the
following activities:

		•	Questionnaire

		•	Audit

		•	Oversight of first articles inspection

		•	Design Verification

		•	Process Validation

    

     

    

 

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Ongoing Apical qualification
and approval will be based upon the following sources of feedback:

		•	Periodic Apical audits

		•	Periodic inspections of received
product

		•	Customer feedback investigations

		•	Ability of Apical
to meet delivery expectations

 

The attached table details the
QSR responsibilities and authorities under this agreement.

 

 

	QSRarea	Nexalin	Apical	Plan/Notes
	
     

    Subpart A
    - General Provisions

	§ 820.1 - Scope	X	X	
    Both Nexalin
    and Apical shall have independent Quality Systems. 

     

    Apical
    shall be ISO 13485 certified prior to release
    of any product for commercial distribution to the European market.
    If Nexa lin is classified as a Class II device in the European
    market, they shall be certified to ISO 13485 prior to

    release to that market.

	§ 820.3 - Definitions	X	X
	
     

     

     

     

     

     

     

    § 820.5 - Quality system
	
     

     

     

     

     

     

     

     

    X
	
     

     

     

     

     

     

     

     

    X

	
     

    Subpart B -
    Quality System Requirements

	§ 820.20 - Management responsibility	
     

    X
	
     

    X
	Both parties are expected to have a management responsibility process
	
     

    § 820.22
    - Quality audit
	
     

    X
	
     

    X
	Both parties are expected to have an internal audit process.
	
     

     

    §
    820.25
    - Personnel
	
     

     

    X
	
     

     

    X
	Apical shall be able to demonstrate compliance for manufacturing and quality staff.
	 	 
	Subpart C - Design Controls

    

     

    

 

NEX-CNT-00016

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1

 

 

	QSRarea	Nexalin	Apical	Plan/Notes
	
     

    § 820.30 - Design controls
	
     

     

    X    
	   X
	
    All
design control for the product is managed by Apical. If Apical
believes design changes are needed , they
will discuss with Nexalin and await formal notification of design ECO approval before implementation.

     

    Manufacturing
changes shall be documented in the Apical Quality system. Nexalin must be a signatory for all manufacturing changes.

	
     

    Subpart D - Document Controls

	
    

    § 820.40 -
    Document controls
	
    
	X
	
    Apical
    is responsible for controls on documents associated with manufacturing (e.g. OHR,

    component
    specifications, DMR documents).

	
     

    Subpart E - Purchasing Controls

	
    

    § 820.50 - Purchasing controls

 
	
    X
	X
	
    Nexalin will use
    a purchase order or equivalent to request parts manufacture. Apical will maintain purchasing control records for materials and parts purchased
    for the manufacture of the parts.

     

    Apical is responsible
    for Apical approvals of all purchased parts/services for the product.

	 
	Subpart F - Identification and Traceability
	
    § 820.60 -
    Identification
	
     
	X
	Apical shall be compliant with identification requirements during product manufacturing, including assignment of serial numbers.
	
     

    § 820.65
    - Traceability
	 	
    N/A
    - Traceability requirements are

    only required for surgical implants.

	 
	Subpart G - Production and Process Controls

    

     

    

NEX-CNT-00016

Revision
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	QSRarea	Nexalin	Apical	Plan/Notes
	§
    820.70 - Production
    and process controls	
	X
	

    Apical
    will have full responsibility.

	§
    820.72 - Inspection,
    measuring , and
    test equipment	 

     
	X
	

    Apical
    will have full responsibility.

	

     

    §
    820.75 - Process validation
	

    
	X
	Apical
                                            will have full
                                            responsibility. The only anticipated process validation is the overall assembly process
                                            validation.

	 

    Subpart
    H - Acceptance Activities

	 

    §
    820.80 - Receiving, in-process,
    and finished device acceptance
	 

     

     

     
	X
	Apical
                                            will have full responsibility. Apical will generate a certificate of conformance (CoC) for
                                            each device that will be provided to Nexalin.

	§
    820.86 - Acceptance status	 	X	Apical
    will have full responsibility.
	Subpart
    I - Nonconforming Product
	 

     

     

     

     

     

     

     

    §
    820.90 - Nonconforming product
	 

     

     

     

     

     

    

     
	X
	Non-conforming
                                            product reports will be generated by Apical.

     

    Apical
    will provide periodic summaries of nonconforming product reports as
    feedback to Nexalin.

     

    Apical
    shall also maintain a
    nonconforming product process.

	 

    Subpart
    J- Corrective
    and Preventive Action

	

     

    §
    820.100 - Corrective and preventive action

 

	

    X      
	X
	Apical
    and Nexalin will each maintain a CAPA process.
	 
	Subpart
    K - Labeling and Packa.2:in
    2; Control
	 

    

    &
    820.120 - Device labeling
	
    X
	X
	Nexalin
is responsible for designing the
labeling, but may enlist Apical’s help. Apical is responsible for all other elements of this
clause.

    

     

    

NEX-CNT-00016

Revision
1

 

 

	QSR area	Nexalin	Apical	Plan/Notes
	
     

     

     

     

    §
    820.130 - Device
    packa£.ing
	
     

     

     

     

    X       
	X
	
    Nexalin
    is responsib le for design and verifying
    packaging design but may enlist Apical’s help.

     

    Apical
    is responsible for all other packaging operations.

	
     

    Subpart L -
    Handling, Storage,
    Distribution , and Installation

	§ 820.140 - Handling	 	X	Apical
will have full responsibility.
	820.150 - Storage	 	X	Apical will have full responsibility.
	
    § 820.160
    - Distribution
	
    X
	 
	
    Nexalin has full responsibility
    for distribution.

     

    Apical will provide a copy
of the packing slip and CoC for each unit distributed to Nexalin

	
     

    §
    820.170 - Installation
	
     

    X
	 
	Nexalin has full responsibility for installation.
	
     

    Subpart M -
    Records

	§ 820.180 - General requirements	
     

    X   
	X
	Each company is required to maintain records per this clause.
	
     

     

     

    §
    820.181 - Device
    master record.
	
     
	X
	
    Apical will
finalize , release, and maintain the DMR. Nexalin representative
must be a signatory on the DMR and associated documents.

	
     

    §
    820.184 - Device
    history record
	
     

     

     
	X
	Apical will maintain the original records for OHR. A copy will be provided to Nexalin.
	
     

    §
    820.186
    - Quality system record
	
     

    X       
	X
	
    Apical shall
maintain Nexalin’s

    QSR
    per the requirements of this clause.

	
    §
    820.198 - Complaint
    files

 
	
     

    

    X      
	 X
	
    Nexalin will
have full responsibility
for complaint handling.

     

    Apical may
    be asked to participate

    in investigations
and/or corrective actions.

	 
	Subpart N - Servicing

    

     

    

NEX-CNT-00016

Revision
1

 

 

 

	QSRarea	Nexalin	Apical	Plan/Notes
	
     

     

    §
    820.200
    - Servicing
	
     

     

     
	X
	
    The servicing of returned devices

    shall follow Apical’s
    Servicing Process.

	
     

    Subpart O -
    Statistical Techniques

	
     

     

    §
    820.250 - Statistical techniques
	
    X       
	X
	
    Nexalin and Apical
    will comply with this clause as appropriate in their operation (e.g. sampling

    plans)

	
     

     

    § 830
    - Unique Device Identification
	
     

     

     

     

    X       
	X
	
    Nexalin is responsible
    for obtaining the UDI prefix and registering with FDA. Apical is responsible for generation and application of UDI

    labels.

	
     

    ISO 14971 -
    Risk Management
	
    X       
	X
	
    

    Nexalin will have a Risk

    Management File. Apical
    will maintain the file for Nexalin.

	
     

    IEC 62304 and 62366
	
     

    X
	 
	
    

    Nexalin will have full

    responsibility for
    compliance to these standards.

    

     

    

NEX-CNT-00016

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SIGNATURE PAGE

 

AGREED
TOBY:

 

	Apical Instruments	 	Nexalin
	 	 	 
	2971 Spring St

Redwood City, CA 94063

	 	1776 Yorktown, Ste 550

Houston, TX., 77056

	 	 	 
	 	 	 
	Kim Khoe	 	John P. Claude
	Name	 	Name
	 	 	  
	 	 	 
	/s/ Kim Khoe	 	/s/ John P. Claude
	Signature	 	Signature
	 	 	  
	 	 	 
	Director RAQA	 	Consulting Engineer
	Title	 	Title
	 	 	  
	 	 	 
	12/12/2020	 	12/12/2020
	Date	 	Date
	 	 	  
	 	 	 
	N/A	 	N/A
	Tax ID Number (if available)	 	Tax ID Number (if available)

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00339-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00339-of-00352.parquet"}]]