Document:

NEX-CNT-00016

Revision
1

Exhibit
10.4

 

 

 

 

 

 

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

     

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	QSRarea	NexalinApical	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
	 	
    NIA
    - Traceability requirements are

    only required for surgical implants.

	 
	Subpart G - Production and Process Controls

     

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	QSRarea	NexalinApical	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
    cla use .

     

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	QSR area	NexalinApical	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 - Stora£.e	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 insta llation.
	
     

    Subpart M -
    Records

	§ 820.180 - General requirements	
     

    X       X
	Each company is required to maintain records per this claus e.
	
     

     

     

    §
    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

     

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	QSRarea	NexalinApical	Plan/Notes
	
     

     

    §
    820.200
    - Servicing
	
     

     

    X
	
    The seivicing 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.

     

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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
	 	 	  
	 	 	 
	12/21/2020	 	12/21/2020
	Date	 	Date
	 	 	  
	 	 	 
	N/A	 	N/A
	Tax ID Number (if available)	 	Tax ID Number (if available)Exhibit 10.5

 

NEXALIN
TECHNOLOGY, INC.

 

l 776 YORKTOWN, SUITE 550

HOUSTON, TX 77056

 

Mr. Leonard Osser

 

 

Dear Len:

 

Nexalin Technology, lnc. (the
"Company") is pleased to welcome you to serve on its Board of Advisors. We appreciate your willingness to accept this
position, and we look forward to your valuable contributions.

 

Your service
will be for a tenn of one ( l) year, which term may be extended for additional one ( l) year tenns upon our mutual agreement.

 

As consideration
for your service on the Board of Advisors, you shall receive shares of our common stock worth $80,000 based upon the cmTent valuation
of the Company.

 

In connection
with your services to the Company, we expect that technical, business or financial information of the Company ("Confidential Information")
will be disclosed to you. To the extent that Confidential Information is not publicly known or not otherwise previously known by you without
an obligation of confidentiality, you agree not to use (except in connection with your services to the Company) or disclose Confidential
Information to any third party and to take reasonable steps to maintain the confidential nature of all Confidential Information. When
you cease to be a member of the Board of Advisors, you must return all Confidential Information to the Company.

 

By signing this
letter agreement, you represent and wanant that you have no contractual commitments or other legal obligations to a third party that would
prohibit you from perfonning your duties for the Company.

 

On behalf of
the Company, we are excited about your services and look forward to working with you to help make the Company truly great and prosperous.
You may indicate your agreement with these terms and accept this offer by signing and dating the enclosed duplicate original of this letter
agreement and returning it to us.

 

 

*
* * * *

    	 

    	 

    

Page 2

 

 

If you have any questions, please do not hesitate to call us.

 

 

 

	 	Very truly yours,	 
	 	 	 
	 	NEXALIN TECHNOLOGY,
    INC.	 
	 	 	 
	 	By: /s/ Mark White	 
	 	Name: Mark White	 
	 	Title: Chief Executive Officer

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