Document:

Exhibit 10.29

 

 

 

 

 

PUREGRAFT

 

 

 

QUALITY AGREEMENT

 

 

 

	Approved by:	Signature:	Date: 12/06/2018
	 	 	 
	Suneva Medical Inc.	Name Preston Romm	 
	 	Job Title: CEO	 
	 	 	 
	Approved by:	Signature:	Date:
	 	 	6 DEC 2018
	Puregraft LLC	Name: Bradford Conlan	 
	 	Job Title: CEO	 

 

 

	QF0688 Rev. B	Page 1
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Effective Date:12/3/2018

 

    

     

    

 

QUALITY AGREEMENT

 

THIS AGREEMENT is made the
__6__   day of   December 2018,

 

BETWEEN:

 

Puregraft LLC., a Delaware Limited-Liability
Company, located at 420 Stevens Ave, Suite 220, Solana Beach, California 92075 and;

 

Entity (name): Suneva Medical Inc.

 

Address: 5870 Pacific Center Blvd, San Diego, CA 92121

 

Roles and Responsibilities overview (identify
responsible party with checkmark ( ) or other identifier):

 

	Role	Puregraft LLC	Entity
	Supplier	 	 
	Purchaser	 	 
	Legal Manufacturer	 	 
	Distributor	 	 

 

Devices/Device
Groups Concerned:

 

	Puregraft 50/PURE System (5 pack)

 Puregraft 250/PURE System
	Puregraft 850/PURE System 

Puregraft 50 Procedure Kit

 Puregraft 550/IS Instrument Set
	Puregraft DIRECT/PURE Direct Harvesting System 

Puregraft Combined Adapter
	Puregraft Vacuum Lid 

3L Vacuum Canister
	Puregraft Vacuum Lid - Port Replacement Kit

 Puregraft Vacuum Lid - O-Ring Kit

 

	(A)	This Quality Assurance Agreement provides definition related to activities defined in the Agreement
between Purchaser and Supplier.

 

	(B)	Whereas in order for the Supplier to fulfil its obligations as “Supplier ” under
                                  applicable global regulations, the Supplier must grant access to certain confidential information either to the Legal Manufacturer
                                  directly or through the Legal Manufacturer’s Notified Body.

 

	1.	Scope of this Agreement

 

		1.1	This Agreement defines the technical responsibilities of the parties in relation regulations defined
by US FDA, European Commission, Health Canada, and rest-of-world, as applicable.

 

		1.2	This agreement applies to all products and services provided to Purchaser by the Supplier, defined
in specification(s). This agreement is not intended to be comprehensive and may be revised as necessary.

 

		1.3	This Agreement does not and is not intended to cover commercial matters, which may be covered under
separate agreement.

 

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Effective Date:12/3/2018

    

     

    

  

	2.	General
                                            Requirements and Responsibilities

 

		2.1	Quality Control Procedures for Incoming/Raw Materials

 

The Supplier is responsible
for ensuring that the quality of each delivery of Incoming/Raw Materials meets its requirements such that the resultant Products/Services
comply with the specification defined in the Agreement between Purchaser and Supplier.

 

		2.2	Raw Materials, Components and Packaging Materials

 

The raw materials, components,
and packaging materials must be maintained in accordance with the Supplier Quality Management System.

 

		2.2.1	Supplier to notify Purchaser in writing
                                            in advance of any intended raw material changes.

 

		2.3	Manufacturing and Control

 

The Supplier undertakes to ensure
that Manufacturing and control of the Products are strictly in conformity with:

 

		2.3.1	the requirements of the Legal Manufacturer’s Notified Body where applicable; and

 

		2.3.2	the requirements of this Agreement; and

 

		2.3.3	the requirements of the applicable regulatory regulations; and

 

		2.3.4	the Supplier’s Quality Management System.

 

		2.4	Technical File (if applicable)

 

With assistance from the Supplier,
Puregraft is responsible for the assembly and submission of the Technical File.

 

		2.5	Responsibilities - Release of Batches

 

The Supplier will be responsible
for the certification that all batches of the Product are produced in accordance with the specifications defined in the Agreement between
Purchaser and Supplier. A written certification document from the Supplier will accompany each batch delivered to the Purchaser, upon
request.

 

		2.6	Validation

 

It will be for the Supplier
to ensure that processes and equipment used to produce the Product are adequately validated that such validation is suitably documented.
The Supplier must be able to demonstrate to the Competent Authority or Notified Body, where appropriate, that the Product can be consistently
produced in accordance with the regulations, and the Purchaser’s Specification.

 

		2.7	Packaging, Labelling and Affixing CE Marking (If applicable)

 

Responsibility for the design
and content of the labelling and packaging of the Product and for its conformity with the regulations is that of Legal Manufacturer.

 

If applicable; Puregraft will
provide to the Supplier directions and a copy in relation to packaging and labelling of the Product which the Supplier will produce and
affix the CE mark otherwise, Puregraft, will be solely responsible for affixing the CE mark.

 

Batch Documentation

 

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Effective Date:12/3/2018

    

     

    

  

		2.7.1	The
batch file consisting of, test, control and release documentation and distribution data and records for each batch will be maintained
by the Supplier in a secure location for a minimum period of 5 years.

 

		2.7.2	The batch file is stored by the Supplier and may be audited by the Competent Authority or Notified
Body.

 

		2.8	Complaints and Feedback

 

		2.8.1	Complaints and/or feedback will be processed in accordance with the Legal Manufacturer’s Quality Management
System, including assessment for reportability and reporting to relevant government authorities. If applicable; the Registration Holder
will report to the relevant government authority, if required by local country regulations.

 

		2.8.2	If applicable, the Supplier will inform the Legal Manufacturer of all quality complaints and/or feedbacks
and will, where appropriate, provide the Legal Manufacturer with returned samples for examination.

 

		2.8.3	The Supplier will investigate all complaints promptly and, when requested, will provide Purchaser with
a written report. In the case of a Potentially Serious Complaint, the Supplier will acknowledge the complaint to Purchaser, taking appropriate
action, although it is accepted that completion of an investigation may take longer.

 

		2.8.4	Without delay, details of Potentially Serious Complaints regarding the Product and details of investigations
into any Potentially Serious Complaints will be forwarded to the Legal Manufacturer. In the event of the Supplier receiving a complaint
from any Competent Authority they will immediately inform the Legal Manufacturer. Copies of all correspondence will be kept with the Legal
Manufacturer.

 

		2.8.5	The Legal Manufacturer will inform the Supplier of any quality complaints and/or feedback and will,
where appropriate, provide Supplier with returned samples for examination.

 

		2.9	Recall of Batches

 

		2.9.1	The ultimate decision to recall a batch of Product rests with the Legal Manufacturer. The nature and
urgency of a recall of Product will be decided by the Legal Manufacturer when appropriate, following discussions with the Supplier and,
if appropriate, any Regulatory Agency.

 

		2.9.2	Once the decision to recall a batch of Product has been taken, the recall will be initiated by the
Legal Manufacturer.

 

		2.10	Serious Incidents (Applicable to finished device manufacturers only)

 

		2.10.1	If a Serious Incident occurs relating to the Product, the Legal Manufacturer will process the incident
in accordance with the Legal Manufacturer’s Quality Management System.

 

		2.10.2	The Supplier will provide all assistance as may reasonably be required in relation to such reporting
and any subsequent investigation.

 

		2.11	Visits to Supplier Manufacturing site(s)

 

		2.11.1	In order to enable the Legal Manufacturer to check and audit the product and storage conditions (including
procedures), the Legal Manufacturer or its nominated representative may visit the Supplier with reasonable notice.

 

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Effective Date:12/3/2018

    

     

    

 

		2.11.2	Per the European Medical
Device Directive (93/42/EEC Section 3.3) the Legal Manufacturer’s Notified Body or Competent Authority may visit the Supplier in duly
substantiated cases to inspect the manufacturing processes.

 

		2.12	Quality Control Procedures for Process and Product 

 

The Supplier shall be responsible for ensuring
that:

 

		2.12.1	Correct stock rotation of all Raw Materials is utilized (i.e. oldest to be used first).

 

		2.12.2	Each batch shall have appropriate traceability.

 

		2.12.3	Products / Results shall be positively-released where appropriate to ensure they are in accordance
with the Purchaser’s Specifications.

 

		2.13	Product Evaluation

 

		2.13.1	The Supplier shall immediately notify the Legal Manufacturer of any relevant corrective actions or
non-conformances relating to the Product identified by the Legal Manufacturer’s Notified Body.

 

		2.14	Intended Changes to Product

 

		2.14.1	The Supplier, at its earliest opportunity, will immediately notify the Legal Manufacturer of all and
any intended changes to the Product. This is to include, but not be limited to, significant changes to the Product in the form of raw
materials, raw material vendors, manufacturing processes, manufacturing environment, design changes, testing procedures, if this could
affect the product in a negative way (form, fit, function and usability).

 

		2.15	Significant Changes to Quality System or Regulatory Status

 

		2.15.1	The Supplier, at its earliest opportunity, will immediately notify Purchaser of any change to their
Quality System or Regulatory status that could affect the product directly

 

		(a)	Changes in CE Mark status or Quality System Registration

 

		(b)	FDA warning letters/ Form 483

 

		(c)	Significant audit findings or

 

		(d)	In-house failures dispositioned “use-as-is”

 

	3.	Term and Termination

 

		3.1	This Agreement shall come into effect on the date hereof and unless earlier terminated by either party
shall continue in force for a period of one (1) year. After the initial period of one (1) year this Agreement
shall be automatically renewed for a further period of one (1) year and on each anniversary thereafter unless terminated in
accordance with the provisions hereof.

 

		3.2	Either party shall have the right to terminate this Agreement on thirty [30] days’ written notice to
other at any time during the initial period of this Agreement or any extension thereof.

 

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Effective Date:12/3/2018

    

     

    

 

	4.	Key Contact Personnel

 

		4.1	Entity: Suneva Medical Inc.

 

Location: 5870 Pacific Center Blvd, San Diego, CA 92121

 

Phone: 858-550-9999

 

Primary: Preston Romm, CEO

 

Secondary: Pamela Misajon, VP of RA/QA/Compliance

 

		4.2	Puregraft LLC

 

420 Stevens Ave, Suite 220

Solana
Beach, CA 92075

858-348-8050

Bradford Conlan, Chief Executive Officer

 

In addition, Supplier to notify
Purchaser in writing if Supplier intends to discontinue manufacturing operations.

 

 

 

	QF0688 Rev. B	Page 6
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Effective Date:12/3/2018Exhibit 10.30

 

SUPPLY AGREEMENT

 

This Supply
Agreement (the “Agreement”) is made and entered into this 17“day of November, 2015 (the “Effective Date”) by
and between Merit Medical Systems, Inc., a Utah corporation with its principal place of business at 1600 West Merit Parkway, South Jordan,
Utah 84095 (“Merit”) and Suneva Medical, Inc., a Delaware corporation with offices at 5780 Pacific Center Blvd., San Diego,
CA 92121 (“Customer”). Merit and Customer are collectively referred to herein as the “Parties” and each individually
as a “Party.”

 

RECITALS

 

	A.	WHEREAS Merit and Customer are manufacturers of medical device products;
	 	 

	B.	WHEREAS Customer desires to purchase certain products from Merit as set forth
in this Agreement;
	 	 

	C.	WHEREAS Merit is willing to supply Customer with such products, subject to the
terms and conditions set forth herein;

 

NOW, THEREFORE,
for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby incorporate the
above Recitals, which are true and correct, and do agree as follows:

 

AGREEMENT

 

Article
1

 MANUFACTURE AND SUPPLY

 

	1.1	Products. For purposes of this Agreement, the term “Products”
shall mean those products set forth in Exhibit A attached hereto and incorporated herein by this reference. The Products do not meet the
definition of a “custom device” according to Section 520(b) of the Food, Drug and Cosmetics Act and the Investigational Device
Exemptions regulations 21 CFR part 812, or by Council Directive 93/42/EEC (Medical Device Directive (MOD), Article 1(2)(d)).

 

	1.2	Specifications. Merit shall manufacture and supply the Products in accordance
with Merit’s specifications (the “Specifications”). If a Product includes any customizations to Merit’s standard products, the
Specifications will include Merit’s Custom Manufactured Part Specification, agreed to by the Parties, which shall include Customer’s labeling
and packaging requirements, if any (the “CMS”). The Specifications shall be retained by Merit. In the event Customer requests
changes to the Specifications, it shall submit such changes to Merit. Merit shall evaluate such requests, and in the event Merit agrees
to incorporate such Customer requested changes, it will provide Customer with a cost and lead time estimate for such change(s).
	 	 

	1.3	Manufacture of Products. The Products will be manufactured in a FDA registered
and ISO ce1tified facility in compliance with current Good Manufacturing Practices and all applicable laws, rules and regulations, including
any quality systems specified by the FDA for such Products.
	 	 

 

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	1.4	Packaging
and Labeling. Merit agrees to label and package the Products in accordance with the Specifications. Any labeling and packaging specifications
provided by Customer will be set forth in the Product CMS, and Customer agrees, at its expense, to provide Merit (in electronic format
with all photo-ready artwork needed for packaging and labeling of the Products, all package insert language, and packaging and labeling
specifications for any such Products that have custom labeling or packaging, unless Merit agrees otherwise in writing. To the extent
the Product Customer represents and warrants that any use by Merit of the Customer trademarks as authorized herein does and will
not infringe upon or otherwise violate or misappropriate any third party rights. Any changes that Customer elects to make to the Customer
trademarks, or to the Product labeling, packaging, inserts or artwork, shall be submitted by Customer to Merit for review and approval.
Once such changes have been agreed to by the Parties, Merit will use commercially reasonable efforts to incorporate such changes as soon
as is practicable after Merit receives suitable electronic files for such change. Customer shall be responsible for any labeling, packaging,
or inserts that Merit cannot use as a result of any such change request, including all Products bearing such labeling, packaging or inserts.
Merit agrees that it will not sell or deliver any Product manufactured, labeled and packaged specifically for Customer to any other party.

 

Article 2

PURCHASE
OF PRODUCTS

 

	2.1	Purchase
Orders. Merit agrees to supply Customer with Products in accordance with purchase orders issued by Customer (“Purchase Orders”),
subject to the terms and conditions of this Agreement. Merit will provide a written confirmation of each Purchase Order submitted by
Customer within three (3) business days of receipt. Merit will use commercially reasonable efforts to fill Customer’s Purchase Orders
within the requested delivery dates. In the event Merit becomes aware that it will be unable to fulfill a Purchase Order by the requested
delivery date, it will promptly notify Customer of the delay and provide Customer with a revised delivery date.

 

	2.2	Cancellation or Changes. Customer may cancel or change a Purchase Order
only with Merit’s prior approval. In the event Customer requests changes to a Purchase Order (for example, changes to the delivery dates)
or to the Specifications, and such changes affect the time required for performance of the applicable Purchase Order, Merit may request
an equitable adjustment in the price or delivery of the Products, or both. The lead time for any changes to a Purchase Order or to the
Specifications shall start from the date the Parties reach mutual approval of such change. In the event of cancellation or change
to a Purchase Order, or a change to the Specifications, Customer shall reimburse Merit for all (i) finished Product, (ii)works-in-progress ,
and (iii) unusable raw materials and components inventory. Merit agrees to use commercially reasonable efforts to reduce raw materials
and components inventory, if possible.
	 	 

	2.3	Product
Returns. Customer may not return Product at any time, except with Merit’s prior approval. If Merit does grant such prior approval,
Customer shall return Product in accordance with Merit’s Product Return Policy in effect at the time of such return. Merit’s current
Product Return Policy is attached hereto as Exhibit BAA and incorporated herein by this reference.

 

Article 3

PRICE, PAYMENT AND DELIVERY
TERMS

 

	3.1	Price. Pricing for the Products shall be the prices quoted by Merit and
agreed to by Customer, as evidenced by Customer’s issuing Purchase Orders that conform to Merit’s quotations. However, during the Initial
Term, prices shall be as set forth in Exhibit A. Additional costs or charges may occur in the event of changes to the Specifications,
additional customization to the Products, changes to the Product labeling, packaging and inserts, changes to the Product components, or
any expedited or special delivery requests. Merit shall provide Customer with notice of any such additional costs or charges. Unless otherwise
explicitly stated in a quotation, pricing is exclusive of shipping charges and any taxes, which are the responsibility of Customer.

 

	3.2	Delivery Terms. Merit shall ship all orders of Product to Customer’s designated
location, and delivery shall be Ex Works Merit’s manufacturing facility, Incoterms 2010 (“Delivery”). Title to and risk of loss
of each Product shall transfer to Customer upon Delivery.

 

	3.3	Payment Terms. Merit will invoice Customer upon shipment. Customer will
pay invoices within thirty (30) days of the invoice date.

 

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Article 4

TERM AND TERMINATION

 

		4.1	Term. This Agreement will commence on the Effective Date and will continue
for an initial period of three (3) years (the “Initial Term”) unless terminated earlier pursuant to this Article 4. Thereafter;
the Agreement shall automatically renew for additional one (I) year periods
(each a “Renewal Term”) unless terminated earlier pursuant to the terms herein. The Initial Term and any Renewal Term shall
collectively constitute the “Term.”

 

		4.2	Termination. This Agreement may be terminated by either Party:

 

		(a)	If the other Party
files for protection from its creditors under any applicable bankruptcy or insolvency laws, makes an assignment for the benefit of creditors,
or has a receiver appointed for its property;

 

		(b)	If Merit is enjoined,
by a court of competent jurisdiction, or any other judicial, administrative or legal authority, from manufacturing or supplying the Products;

 

		(c)	If the other Party
materially breaches this Agreement in any way and fails to cure such breach within thirty (30) days of receipt of the non-breaching Party’s
written notice thereof;

 

		(d)	If a Force Majeure Event (as defined in
Section 9.9) occurs; or

 

		(e)	At any time upon ninety (90) days written notice (the “Notice Period”).

 

Merit may terminate
this Agreement immediately upon the occurrence of a change of control of Customer or of a change of Customer’s key personnel, including,
but not limited to, any change of the principals or management, by providing notice to Customer. Customer shall notify Merit within five
(5) business days of any such change in control or key personnel. For purposes of this Agreement, a “change of control” means
a change in the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of the
Customer; whether through the ownership of voting securities, by contract, or otherwise.

 

		4.3	Obligations Upon Termination. In the event of termination of the Agreement
pursuant to Section 4.2(v), Merit will continue to process any open but unfulfilled Purchase Orders that are in existence as of the date
of notice of termination. During the Notice Period, Customer may also place new Purchase Orders materially similar in size and scope to
Purchase Orders placed by Customer prior to the Notice Period.

 

		4.4	Effect of Termination.. In the event of termination of the Agreement, except
for Customer’s payment obligations, neither Party shall be liable to the other Party because of such termination for compensation, reimbursement
or damages on account of the loss of prospective profits or anticipated sales or on account of expenditures, inventory, investments, or
cost of replacement products.

 

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Article 5

LIMITED WARRANTY AND DISCLAIMER

 

		5.1	Limited
Warranty and Disclaimer. Merit shall manufacture and package the Products in accordance with the Specifications. Merit warrants that
the Products will (i) conform to the Product specification as set forth in the Specifications at the time of delivery to Customer and
(ii) will be :free from defects in materials and workmanship under normal use for the shelf life of the Products. Merit’s sole obligation
and liability for, and Customer’s exclusive remedy with respect to, any Product which fails to meet such warranty shall be, at Merit’s
option, either to repair or replace such Product at no charge to Customer or to issue Customer a credit for any such Product in the amount
of the original invoice price. Customer must make claims promptly and provide Merit a reasonable opportunity to investigate and cure
the non-conformance or defect. Merit agrees to use commercially reasonable efforts to cure the non-conformance or defect within a reasonable
period of time (based on the particular circumstances of such non-conformance or defect) following receipt by Merit of all relevant information
to initiate such investigation. The foregoing warranty shall not apply to any Products that have (i) been repaired, refurbished or reprocessed,
other than with Merit’s written authorization and by Merit’s approved procedures, (ii) been altered, changed or modified
other than by Merit, (iii) been subjected to misuse, abuse, improper maintenance, negligence, or accident (iv) been damaged by excessive
physical or electrical stress, (v) had a serial number or any part thereof altered, defaced, or removed, (vi) use of a Product at the
instruction of Customer or promoted by Customer (a) outside the approved indications for use as cleared by the relevant competent
authority, (b) contrary to the use outlined in the Specifications, or (c) in an application or environment for which such Products were
not approved, designed or contemplated. To the extent any specifications, Product design, or any labeling, packaging or package insert
instructions have been provided by Customer, Customer bears all responsibility for such specifications, designs, labeling, packaging,
and package inserts. Customer agrees that any technical advice furnished by Merit regarding use of any Product is provided without warranty,
duty, or compensation of any kind, and Merit assumes no obligation or liability therefor, all such advice being given and accepted strictly
“AS IS” and at Customer’s sole risk. THE LIMITED WARRANTY CONTAINED HEREIN IS EXCLUSIVE, AND MERIT MAKES NO OTHER REPRESENTATIONS
OR WARRANTIES OF ANY KIND WHATSOEVER TO CUSTOMER, ITS END-USERS, OR ANY THIRD PARTIES WITH RESPECT TO THE PRODUCTS AND HEREBY EXPRESSLY
DISCLAIMS ANY AND ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO, NON-INFRINGEMENT,
THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, EVEN IF MERIT IS AWARE OF SUCH PURPOSE.

 

Article
6

INDEMNIFICATION LIMITATION
OF LIABILITY

 

		6.1	Indemnification by Merit. Subject to the terms, conditions
and limitations set forth in this Agreement, Merit shall, at its own expense, defend, indemnify and hold Customer harmless from any claims,
suits or proceedings brought against Customer, and for costs and expenses associated therewith (including reasonable attorneys’ fees)
to the extent that any Product supplied by Merit to Customer in accordance with this Agreement causes death, injury or damage to person
or property of any third party, or infringes any valid United States patent issued before the date of sale of the Product to Customer’s
end-user. Merit’s obligations contained in this paragraph shall be subject to the conditions that Customer (a) promptly notify
Merit in writing of any such claim, suit or proceeding promptly after Customer shall have received notice or obtained knowledge thereof,
(b) provide Merit with full cooperation, information and assistance as reasonably requested by Merit in such defense, at Customer’s expense,
and (c) allow Merit to control the  United States patent, Merit reserves
the right, at its option and in lieu of any other obligations or responsibilities under this paragraph, to modify or replace the affected
Product to eliminate the alleged infringement, to obtain a license to cure the alleged infringement or to give Customer a refund of the
price of the affected Product. Merit shall have no liability under this paragraph to the extent such claim, suit or proceeding is caused
by or arises out of: (i) any Customer product; (ii) combination of a Product with any other product not supplied by Merit; (iii) modification
of a Product other than by Merit; (iv) Customer’s mishandling of a Product; (v) use of a Product at the instruction of Customer or promoted
by Customer outside the approved indications for use as cleared by the relevant competent authority, contrary to the use outlined in
the Specifications, or in an application or environment for which such Products were not approved, designed or contemplated; (vi) the
negligence, omissions or other misconduct of Customer; (vii) representations and warranties regarding the Products made by Customer or
any agent, salesperson, or representative of Customer; or (viii) any designs, specifications, instructions or materials requested or
provided by Customer. The foregoing states the entire responsibility of Merit, and the exclusive remedy of Customer, with respect to
the alleged infringement or misappropriation of intellectual property or other third party rights by a Product.

 

		6.2	Indemnification by Customer. Customer shall, at its
own expense, defend, indemnify and hold harmless Merit from any claims, suits, or proceedings brought against Merit and for costs and
expenses associated therewith (including reasonable attorneys’ fees) arising out of, based on, caused by, or relating to: (i) any Customer
product; (ii) modification of any Product by Customer; (iii) Customer’s mishandling of any Product; (iv) use of a Product at the
instruction of Customer or promoted by Customer outside the approved indications for use as cleared by the relevant competent authority,
contrary to the use outlined in the Specifications, or in an application or environment for which such Product was not approved, designed
or contemplated; or (v) any design, specification, instruction or materials requested or provided by Customer. No settlement shall be
entered into without Merit’s written consent, which shall not be  unreasonably withheld.

 

		6.3	LIMITATION
OF LIABILITY. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED HEREIN, MERIT'S SOLE AND EXCLUSIVE LIABILITY FOR ANY BREACH OF THIS AGREEMENT
OR ANY OTHER CLAIM(S) RELATING TO THE PRODUCTS SHALL BE LIMITED TO EITHER REPAIR OR REPLACEMENT OF THE DEFECTIVE PRODUCT OR A REFUND
OF THE PURCHASE PRICE, AT MERIT'S OPTION. IN NO EVENT SHALL MERIT BE LIABLE TO CUSTOMER OR ANY THIRD PARTY FOR ANY PUNITIVE, SPECIAL,
INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER BASED UPON LOST GOODWILL, LOST RESALE PROFITS, WORK STOPPAGE, PRODUCT FAILURE, IMPAIRMENT
OF OTHER PRODUCTS, OR OTHERWISE AND WHETHER ARISING OUT OF BREACH OF WARRANTY, BREACH OF CONTRACT, NEGLIGENCE, OR OTHERWISE, EVEN IF
MERIT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

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Article 7

CONFIDENTIALITY

 

		7. I	Confidential Information. Merit and Customer may have access to each other’s
                                                                               Confidential Information during the Term of this Agreement. For the purposes of this Agreement, “Confidential
                                                                               Information” means any and all information or proprietary materials (in every form and media) not generally known in the
                                                                               relevant trade or industry made available by either Party (in such case, the “Disclosing Party”) to the other (in such
                                                                               case, the “Receiving Party”) and which the Disclosing Party designates as confidential or may reasonably be understood
                                                                               as confidential, including but not limited to Product information, regulatory
                                                                               documentation (including licenses, permits, and applications, U.S. Food and Drug Administration applications, substantial
                                                                               equivalence determination letters, U.S. pre-market approvals, investigation device exemptions, international registrations, CE
                                                                               dossiers, technical files, and any amendments to the foregoing), existing or contemplated products, designs, inventions, technology,
                                                                               processes, know-how, trade secrets, technical data, engineering, specifications, techniques, methodologies and concepts, and any
                                                                               information related thereto, and information relating to vendors, agreements, customer information, pricing, quality systems,
                                                                               strategic and tactical plans, business plans, sales and marketing plans, testing data, research and development, clinical
                                                                               literature, clinical trial data, communications with physicians, internal or external inspection/audit reports, and corrective
                                                                               action plans. The Receiving Party will maintain Confidential Information in confidence using the same standard of care it uses to
                                                                               maintain its own Confidential Information, but in any case no less than reasonable care, and will not use such information for
                                                                               itself or others except as provided in this Agreement. Such obligation of confidentiality and non-use shall not apply to information
                                                                               which (a) is known to the Receiving Party prior to the disclosure as demonstrated by documentary evidence; (b) is publicly known as
                                                                               of the date of the disclosure; (c) becomes publicly known after the date disclosure through no fault of the Receiving Party; (d) is
                                                                               received by the Receiving party from a third party who has, to the Receiving Party’s knowledge, no obligation of
                                                                               confidentiality to the Disclosing party; or (e) is independently developed by the Receiving party without reference to or use of the
                                                                               Disclosing Party’s Confidential Information, as demonstrated by documentary evidence. The restrictions on disclosure contained
                                                                               in this Section 7.1 shall not apply to any information which is required to be disclosed by a valid court rule or governmental
                                                                               law or regulation, provided that the Receiving Party gives the Disclosing Party prompt notice of any such requirement and cooperates
                                                                               with the Disclosing Party in attempting to limit such disclosure and obtain confidential treatment thereof.

 

		7.2	Obligations
Upon Termination. Upon termination of this Agreement, each Party shall return to the other all Confidential Information of the other
Party within thirty (30) days after notice of termination, except for Confidential Information which is embodied in documents or records
that the Receiving Party is required to retain under applicable law and regulation.

 

		7.3	Remedies.
The Parties acknowledge that monetary damages may be an inadequate remedy for any breach by a Party of its obligations under this
Article 7 and that the non-breaching Party shall be entitled to seek injunctive relief to enforce the breaching Party’s obligations,
in addition to any other remedies the non-breaching Party may be entitled to.

 

Article 8

REGULATORY COMPLIANCE AND
QUALITY

 

		8.1	Regulatory Compliance. The Party that is the legal
manufacturer, as indicated on any Product labeling, assumes all responsibility for conducting performance testing, attending to Product
qualification, obtaining marketing clearance and registrations for the Products, and post-market surveillance responsibilities (complaints,
recalls, regulatory assessment of design/material changes to the device, etc.). It is the responsibility of the Party that is the legal
manufacturer to compile the necessary technical documentation, including risk management, required to obtain marketing clearance and
Product registration. Merit will maintain medical device registration and device listings for the Product, to the extent required by
the Specifications. For any Product for which Merit maintains regulatory clearance, it is Customer’s responsibility to ensure that the
clinical application of the Product is consistent with the regulatory clearance obtained by Merit, or, when Customer’s clinical application
or indications for use differ from Merit’s cleared regulatory application or when Merit does not maintain regulatory clearance for the
Products, it is Customer’s responsibility to ensure compliance with all regulatory and other applicable laws, rules,
regulations and standards. To the extent Customer reasonably requires Merit’s assistance in fulfilling product registration, regulatory
or licensing responsibilities, Customer shall submit a request for assistance to Merit. Merit shall evaluate such requests on a case-by-case
basis to determine if it is willing and able to assist Customer with such request. Merit reserves the right to charge Customer for providing
such assistance, including but not limited to the development of any technical file(s) specific to the Products or other regulatory materials
requested by Customer. Where appropriate, Merit may allow access to applicable regulatory filings lodged by Merit with regulating authorities,
including documentation in support of device clearance and registration to the extent reasonably required by Customer to support its
product registration, regulatory and licensing responsibilities.

 

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		8.2	Quality. The Parties' quality system and regulatory compliance obligations
concerning the Products are as agreed by the Parties in separate· agreements signed by the Patties.

 

Article
9 

MISCELLANEOUS

 

		9.1	Notices. All notices and other communications under this Agreement shall
be in writing and delivered by US Mail, or by overnight courier service, and addressed as follows:

 

	 	If to Merit:	If to Customer:	 
	 	Merit Medical Systems, Inc. 	Suneva Medical, Inc.	 
	 	1600 West Merit Parkway	5780 Pacific Center Blvd.	 
	 	South Jordan, Utah 84095	San Diego, CA 92121	 
	 	Attn: VP OEM	 	 
	 	Phone: 801.253.1600		 
	 	 		 
	 	With a copy to “General Counsel” at the same address.	 

 

		9.2	Governing Law. This Agreement shall be governed by and construed in accordance
with the laws of the State of Utah, U.S.A., and all applicable federal laws of the United States of America without reference to conflict
or choice of law provisions.

 

		9.3	Regulatory
Compliance. Each Party agrees that it will comply with all applicable laws, regulations, rules, requirements and ordinances of any
regulatory authority, including but not limited to ISO requirements, the United States Food and Drug Administration (or its territorial
equivalent) applicable to the use, re-use, manufacture, sale, distribution, transportation, exportation or importation of Products for
its particular· roles and responsibilities hereunder. Customer shall not sell any Products until such Products are fully qualified
under all applicable law for sale and use within the applicable territory.

 

		9.4	Export/Import Controls. The Patties agree that each will fully comply with all
                                                                                            applicable export laws and regulations of the United States government and any other applicable foreign or domestic governmental
                                                                                            authority. Each Party shall comply with all applicable import laws and regulations, including obtaining licenses and other import
                                                                                            certifications. Customer shall take appropriate measures to ensure that the Products at·are not diverted or re-exported to
                                                                                            destinations or persons of restricted trade as to which the United States government has placed an embargo against the shipment of
                                                                                            Products.

 

		9.5	Compliance
with  Laws. Customer represents and warrants that it shall comply at all times with the requirements of the U.S. Foreign
Corrupt Practices Act, the U.K. Bribery Act, and any other applicable anti-corruption
laws and regulations, as they may be amended from time to time.

 

		9.6	Relationship of Parties. Merit is an independent contractor engaged by
Customer to supply the Products. Nothing in this Agreement shall make either Party the legal representative or agent of the other, nor
shall either Party have the right or authority to assume, create or incur any liability or obligation of any kind, express or implied,
against, in the name of, or on behalf of, the other Party.

 

		9.7	Assigrnnent. This Agreement is binding upon the Parties and their respective
successors and assigns authorized hereunder. Customer may not assign, sublicense or transfer its rights or delegate its obligations under
this Agreement, by operation of law or otherwise, without Merit’s prior written consent, which consent shall not be unreasonably withheld.
Assigrnnents or delegations prohibited by this Section 9.7 include, without limitation: (a) the voluntary transfer of rights, (b) the
transfer of rights by operation of law, (c) the transfer of rights by merger or consolidation, or (d) a change of control.

 

		9.8	Entire Agreement. This Agreement and the Exhibits attached hereto constitute
the entire agreement of the Patties with respect to the subject matter and supersede all prior discussions, agreements and understandings
between the Parties. This Agreement may not be amended or modified except by a written instrument signed by both Parties. Any terms and
conditions contained on Customer’s Purchase Order or other documentation that are inconsistent with the terms of this Agreement shall
be null and void.

 

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		9.9	Force
Majeure. Except for payment of amounts due to Merit for Products already delivered to Customer, neither Patty shall be held liable
or responsible to the other Patty or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling
or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable control
of the non-performing Patty, including without limitation, acts of God, acts of local, state or national governments or public agencies,
acts of public enemies, acts of terrorism, war·, acts of war (whether war be declared or not), acts of civil or military authority,
labor disputes, embargoes, rationing, quarantines, blockades, sabotage, earthquakes, fire, flood, epidemics, riots, insurrections, strikes,
lockouts or other labor disturbances (each of the preceding events a “Force Majeure Event”). The non-performing Party shall
notify the other Patty of such Force Majeure Event within thirty (30) days after such occurrence by giving written notice to the other
Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect. In
addition, if due to any such cause Merit is unable to produce sufficient
Product to meet all demands from customers and internal uses, Merit shall have the right to allocate production among its customers and
plants in any manner which Merit may determine to be equitable, without any liability or responsibility to Customer. Notwithstanding
the foregoing, the non-performing Patty shall use commercially reasonable efforts to remedy its inability to perform.

 

	9.10	No Conflicts. Each Party represents and warrants to the other Party that
this Agreement does not conflict with any other obligations which the Party has under any other agreement, and that each Party has the
authority and has obtained all authorizations required to enter into this Agreement.
	 	 

		9.11	Waiver. The rights and remedies of the Parties to this Agreement are cumulative
and not alternative. Neither the failure nor any delay by any Patty in exercising any right, power or privilege under this Agreement will
operate as a waiver of such right, power or privilege, and no single or partial exercise of any such right, power or privilege will preclude
any other or further exercise of such right, power or privilege or the exercise of any other right, power or privilege.

 

		9.12	If any provision of this Agreement is held invalid or unenforceable by any court
of competent jurisdiction, the other provisions of this Agreement will remain in full force and effect. Any provision of this Agreement
held invalid or unenforceable only in part or degree will remain in full force and effect to the extent not held invalid 01·
unenforceable.

 

		9.13	Counterparts. This Agreement may be executed in one or more counterparts,
each of which shall be deemed an original, but all of which shall be one and the same document.

 

		9.14	Survival. The provisions of Sections 2.3, 4.3, 4.4, 9.1 to 9.9, 9.11 to
9.14, Article 5, Article 6, and Article 7 shall survive the expiration or termination of this Agreement

 

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IN WITNESS WHEREOF,
the authorized representatives of the Parties have executed this Agreement as of the Effective Date.

 

	MERIT MEDICAL SYSTEMS, INC.	 	SUNEVA MEDICAL, INC.
	 	 	 	 	 
	By:	/s/ Michael Blackham 	 	By:	/s/ Stewart
M. Brown
	Name: 	Michael
Blackham	 	Name: 	Stewart
M. Brown
	Title:	V, P, , Global OEM & Coatings	 	Title:	Vice President
  Legal Affairs

 

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EXHIBIT B

 

MERIT PRODUCT RETURN POLICY

 

Products Eligible for Return:

 

Products
that are defective, as determined by Merit in its sole discretion, or shipped due to Merit’s processing error may be returned. Merit may
also accept the return of standard, unopened, non-tampered, non-reprocessed, non-refurbished, and non-expired products that Merit receives
within 90 days from the invoice date of the original shipment order and that Merit determines to be in resalable condition. Obsolete products,
discontinued products, or products with less than 6 month expiration dates are not returnable. Due to limited market demand, Merit will
not accept the return of any custom products developed solely for customer’s individual needs; special order products, including custom
volumes.

 

Authorization Process and
Credit:

 

Upon review and acceptance
of Customer’s return information, Merit will provide the Customer a return goods authorization (RGA) number and return instructions. Returned
products must be accompanied by the original order, invoice and packing slip and must include the RGA number on the outside of the box.
Upon receipt of the products in good order, Merit may approve the return and credit the Customer’s account subject to a 20% restocking
fee. Merit shall provide the Customer with a return freight account code for defective products or products that were shipped due to Merit’s
processing error. Non-defective products must be returned within 90 days from invoice date of original shipment. Returns due to product
defect, or Merit’s processing error shall not be subject to a restocking fee.

 

Cancellation of purchase
Orders:

 

Purchase
orders may be cancelled for non-custom products within the same business day, provided that the order has not yet been processed. Purchase
orders are non-cancellable for custom products and custom volumes once production of the custom product order has been started.

 

Freight
for Returned Products:

 

All
products returned to Merit should be packaged to prevent damage in shipping and insured against damage or loss. Merit assumes no liability
for damage to products shipped to Merit. The Customer is responsible for all freight charges and product damage incurred during shipment
to and from Merit, except for products shipped due to Merit’s processing error or defective products. Products without Merit authorization
will be refused.

 

Contact Information:

 

To request return
authorization for OEM products purchased in the United States, please contact the OEM Customer Service Department at (800) 637-4839 with
return information including: catalog number, lot number, invoice number, invoice date, purchase order number and the reason for return.
Additional information may be required.

 

This Product Return Policy is subject
to change by Merit without notice.

 

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