Document:

ex10-3.htm

CONSULTING AGREEMENT

THIS AGREEMENT (the “Agreement”) is made and entered into this 4th day of November, 2013, by and between TechiT Marketing Group, Inc., (hereinafter referred to as “TECHIT”) and Mirror Me, Inc., (hereinafter referred to as the “Company”) (together the “Parties”).

WHEREAS, the Company wishes to engage TECHIT for the purpose of designing and developing the Company’s website (the “Website”), subject to the terms and conditions hereinafter set forth; and

WHEREAS, TECHIT wishes to design and develop the Company’s Website and agrees to do so under the terms and conditions of this Agreement; and

WHEREAS, the Company wishes to engage TECHIT for the purpose of designing and developing the Company’s mobile application (the “Application”) on the terms and conditions set forth below; and

WHEREAS, TECHIT wishes to develop the Company’s Application and agrees to do so under the terms and conditions of this Agreement.

NOW THEREFORE, in consideration of the above recitals and mutual promises and benefits contained herein, the Parties hereby agree as follows:

1.           Term of Agreement

The term of this Agreement shall commence as of the date of this Agreement and shall continue for 24 months, unless canceled with or without cause by either party on thirty (30) business days prior written notice.

2.           Scope of Work

	
A.  

	
WEBSITE. TECHIT will provide website consulting, design and management, to the Company by assisting in the management of corporate technology. TECHIT will provide such services utilizing qualified personnel that may include, but not be limited to TECHIT, and/ or contracted third-party providers.

Such activities will include:

	
(i)  

	
Advise as to efficient design and function of Company’s Website;

	
(ii)  

	
Assist the Company in communicating with the Company’s subscribers;

	
(iii)  

	
Assist in the Company’s development and management of the Company’s primary social networking Website.

  

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B.  

	
APPLICATION. TECHIT agrees to do each of the following:

	
(i)  

	
Create the Application of the Company, and extend its best efforts to ensure that the design and functionality of the Application meets the Company’s specifications.

	
(ii)  

	
On completion of the Application, assist the Company in installation of the Application to its final location, which assistance will include helping the Company with its upload of the finished files to the Company’s selected Web-hosting company and submitting for approval on the Apple Store.

	
(iii)  

	
Provide all files and code to the Company.

	
(iv)  

	
Provide services and an Application that are satisfactory and acceptable to the Company and substantially free of defects.

	
(v)  

	
Communicate with the Company regarding progress it has made each week.

	
(vi)  

	
Provide continued support for the Application for 90 days after the iphone application is successfully approved on the Apple Store.

3.           Compensation

For work performed by TECHIT as described under Section 2 above, the Company shall pay an initial payment of $2,500 and shall pay on an hourly basis as new services are performed and fees are earned. TECHIT agrees to bill on a monthly basis for services performed in the preceding month. TECHIT shall provide monthly statements that identify the services performed, the fees charged for those services, and any costs incurred.

4.           Proprietary Work Product and Confidential Company Information

The Company acknowledges and agrees that any work product produced by TECHIT is for the sole use of the Company and is not intended for distribution to, or to be relied upon by, any third parties. The foregoing shall not limit or restrict or affect any disclosures that the Company determines are appropriate to be made under applicable securities laws or rules or regulations of any securities exchange and shall not limit or restrict or affect any obligation that any persons performing services hereunder may have to the Company and shall in no way restrict the ability of the Company to share any such work product with its accountants, auditors, advisors, attorneys, officers, directors, board or board committees or others who the Company determines have a reason to know such information in connection with their dealings with the Company.

  

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In addition, TECHIT acknowledges and agrees that as a result of the services to be provided hereunder, the persons performing such services may acquire knowledge and information of a secret and confidential nature. TECHIT further acknowledges and agrees that this information constitutes valuable property of the Company generally not being disseminated or made known to persons or organizations outside the Company at all, or if made known, being done so only under specific and restrictive conditions such as to ensure that it does not become readily available to the public, and also that confidential information of others may be received by the Company with restrictions on its use and disclosure. Accordingly, TECHIT agrees that:

	
(i)  

	
TECHIT and any person performing any services on its behalf hereunder shall not, during the term of this Agreement or at any time thereafter, disclose to anyone outside the Company or use in other than the Company’s business any secret or confidential information of the Company or its subsidiaries or affiliates, except as authorized by the Company. The Company information that is not readily available to the public shall be considered secret and confidential for the purpose of this Agreement and shall include, but not be limited to, information relating to the Company, its subsidiaries and affiliates, customers, processes, products, apparatus, data, compounds, business studies, business and contracting plans, business procedures and finances;

	
(ii)  

	
TECHIT and any person performing any services on its behalf hereunder shall not, during the term of this Agreement or at any time thereafter, disclose to any other person or use secret or confidential information of others that, to its knowledge, has been disclosed to the Company with restriction on the use or disclosure thereof, in violation of those restrictions;

	
(iii)  

	
TECHIT and any person performing any services on its behalf hereunder shall not, during the term of this Agreement or at any time thereafter, disclose to the Company or induce the Company to use, without prior permission of the owner, any secret or confidential information or material of others of which they are or may become possessed; and

	
(iv)  

	
Notwithstanding the foregoing, TECHIT and any person performing services on its behalf hereunder shall not be liable for the disclosure of information that may otherwise be deemed confidential hereunder:

	
a)  

	
if the information is in, or becomes part of, the public domain, other than by disclosure of the information by TECHIT; or

	
b)  

	
if the information is furnished to a third party by the Company without restriction on the third party’s right to disseminate the information; or

	
c)  

	
if TECHIT can document that the information is already of record in its files at the time of disclosure, or is disclosed to TECHIT by a third party as a matter of right; or

	
d)  

	
if the information is disclosed with the Company’s written approval; or

  

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e)  

	
if the information is compelled to be revealed via subpoena, civil investigative demand or other judicial or administrative process, provided that in such event TECHIT shall provide the Company (unless prohibited from so doing) with as much advance notice as is practicable so that the Company may seek an appropriate protective order, and shall limit disclosure strictly to those items of information as to which disclosure is required.

5. Client Cooperation; Reliance on Client’s Information

The Company acknowledges and agrees that the ability of TECHIT to perform its services under this Agreement requires the full cooperation and assistance of the Company and its personnel. The Company agrees to perform all tasks assigned to the Company as set forth in this Agreement or a Change Order, and to provide all assistance and cooperation to TECHIT in order to complete timely and efficiently the Website and Application.  The Company agrees to provide initial information, and supply all content for the Application. TECHIT shall not be deemed in breach of this Agreement, the Services, a Change Order, or any milestone in the event TECHIT’s failure to meet its responsibilities and time schedules is caused by the Company’s failure to meet (or delay in) its responsibilities and time schedules.  In the event of any such failure or delay by the Company, all of TECHIT’s time frames, milestones, and/or deadlines shall be extended as necessary.  The Company shall be responsible for making, at its own expense, any changes or additions to the Company’s current systems, software, and hardware that may be required to support operation of the Website.  Unless otherwise contracted with TECHIT or reflected in a Change Order, the Company shall be responsible for initially populating and then maintaining any databases on the Website as well as providing all content for the Website. With the execution of a Change Order specifically asking TECHIT to assesses the Company’s systems, software and hardware from time to time, TECHIT may agree to perform this function at normal TECHIT rates.

	
6.  

	
Conflicts of Interest

Nothing contained in this Agreement or otherwise, shall diminish or impair the right of TECHIT to accept engagements, directly or indirectly, to the Company’s financial or other professionals provided such engagements do not involve the relationship of financial or other professionals to the Company. The confidentiality provisions of this agreement shall not be superseded or limited as a result of this paragraph and no obligations of TECHIT hereunder (or its personnel performing services hereunder) shall be limited as a result of this paragraph.

	
7.  

	
Limitation of TECHIT Liability

To the extent permitted by applicable law, if TECHIT fails to perform its obligations under or is otherwise in breach of or default under this Agreement, the maximum liability of either or both of them in respect thereof shall be limited to an amount equal to the aggregate of all fees and expenses paid to them pursuant to this Agreement. The foregoing shall not limit any liability resulting from gross negligence, willful misconduct, violation of law or bad faith and shall not limit any duties or obligations that may exist.

  

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8.  

	
Notices

All notices, requests, demands and other communications provided for by this Agreement shall be in writing addressed to the parties at the address for such party first set forth above, and shall be transmitted by either facsimile (fax), personal or overnight courier delivery or by certified mail. All notices, etc. shall be deemed given when received by the party to whom it is addressed.

9. Successors and Assignees

This Agreement shall inure to the benefit of, and be binding upon, each the Company and TECHIT and their respective successors and assignees. Neither party may assign its rights and/or obligations under this Agreement without the written consent of the other party, which consent shall not be unreasonably withheld or delayed, and which shall not be withheld in connection with a sale or change of control transaction as to any deemed assignment that results therefrom.

10. Applicable Law

This Agreement shall be governed by, and construed in accordance with, the laws of the State of California as if the contract were performed wholly within the state.

11.            Amendments

No amendment, modification, termination or waiver of any provision of this Agreement or consent to any departure by any party therefrom shall be effective unless in writing signed by the parties hereto, and, in any event, shall be effective only in the specific instance and for the specific purpose for which given.

12.            No Waiver; Cumulative Remedies

No failure or delay on the part of either party in exercising any right, power or remedy hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any such right, power or remedy preclude the exercise of any other right, power or remedy. The remedies herein provided are cumulative and not exclusive of any remedies provided by law.

13.            Headings

Headings in this Agreement are for convenience only and shall not be used to interpret or construe its provisions.

14.            Counterparts

This Agreement may be executed in two or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.

  

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15.            Waiver of Jury Trial

Each of the parties to this Agreement hereby waives its right to a jury trial with respect to any claim, action, suit or proceeding made or brought by one of the parties against the others in connection with or arising under this Agreement.

16.            Independent Contractor Relationship

TECHIT shall serve as an independent contractor to the Company pursuant to the terms and conditions of this Agreement. This Agreement does not create and shall not be construed to create a relationship of principal and agent, joint venturer, co-partners, employer and employee, master and servant or any similar relationship between TECHIT and the Company, and the parties hereto expressly deny the existence of any such relationship.

17.            Entire Agreement

This Agreement incorporates the entire understanding of the parties, and amends and supersedes all prior agreements of the parties, with respect to the subject matter of this Agreement.

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their respective officers thereunto duly authorized, as of the date first written above.

SIGNATURES

Mirror Me, Inc.

/S/ Luz Vazquez                                              

Luz Vazquez

President

TechiT Marketing Group, Inc.

/S/ Ryan Faught                                              

Ryan Faught

President

 

 

  

6dxcm12312013ex1028

[*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.

Exhibit 10.28

Amendment Number Three to Non-Exclusive Distribution Agreement

This Amendment Number Three to the Non-Exclusive Distribution Agreement (“Amendment Number Two”) is made as of this 4 day of December, 2013, by and between DexCom, Inc., a Delaware corporation, with a principal place of business at 6340 Sequence Drive, San Diego, California 92121 (the "Company") and RGH Enterprises, Inc. d/b/a Edgepark Medical Supplies, an Ohio corporation with offices located at 1810 Summit Commerce Park, Twinsburg, Ohio 44807 (the “Distributor”). 

WITNESSETH

WHEREAS, Company and Distributor previously entered into a Non-Exclusive Distribution Agreement, effective April 30, 2008, as amended on March 29, 2011 and March 28, 2013 (the “Agreement”). 

WHEREAS, Company and Distributor wish to amend the Agreement as set forth herein in accordance with Section 2.2 and 17.10 of the Agreement. 

THEREFORE, Company and Distributor agree as follows:  

 1.  SECTION 2.  Section 2.2 is amended and restated in its entirety as follows:

2.2    New products may be added to Schedule 1 and included within the scope of the Agreement at the sole and exclusive discretion of the Company.  Notice for new products shall be deemed duly given if sent by prepaid mail, addressed to the party at the address set forth at the beginning of this Agreement, or to such other address as the parties may have furnished each other in writing.  In addition, the Company may amend the pricing set forth on Schedule 1 with [****]  advance notice provided to Distributor.

[*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.

REST OF PAGE INTENTIONALLY LEFT BLANK

2.    SCHEDULE 1.  Schedule 1 is amended to include the following Products:  

Dexcom G4 Platinum - Pediatric
 
	
			
	Product
	Description
	Transfer Price*

	STK-KD-001
	Dexcom G4 PLATINUM Pediatric Receiver Kit – BLK
	[****]

	STK-KD-PNK
	Dexcom G4 PLATINUM Pediatric Receiver Kit – PNK
	[****]

	STK-KD-BLU
	Dexcom G4 PLATINUM Pediatric Receiver Kit – BLU
	[****]

       
3.      SCHEDULE 5.  Schedule 5 is amended and restated in its entirety as follows:  

SCHEDULE 5

Quality Agreement
		
	1.0
	SCOPE

		
	1.1
	This Quality Agreement (the “Quality Agreement”) is incorporated within the Distribution Agreement dated April 30, 2008, as amended on March 29, 2011 and March 28, 2013 between Distributor and Company pertaining to the distribution and sale of Products.  Capitalized terms not otherwise defined herein shall have the meaning assigned to them in the Agreement.

		
	1.2
	This Quality Agreement shall be effective on the Effective Date and shall remain in effect until the Agreement expires, is terminated or the Quality Agreement is modified.

		
	2.0
	DEFINITIONS / ACRONYMS

		
	2.1
	“Applicable Documents”:  Documents used to develop a specific document (i.e. standards, regulations) and documents referenced in the text of the specific document.

		
	2.2
	"Government Agency" means any body which has the authority to act on behalf of the government of the Union or State to ensure that the requirements of all 

[*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.

laws applicable to the Products and Distributor are carried out and adhered to in the State.
		
	2.3
	"Customer Complaint" means any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market.

		
	2.4
	“CGM”: Continuous Glucose Monitoring.

		
	2.5
	“Correction” means repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location.

		
	2.6
	“Document” means any information, either written or stored electronically, including specifications, procedures, standards, methods, instructions, plans, files, forms, notes, reviews, analyses, and reports.

		
	2.7
	“Government Agency” means a federal (e.g. FDA) or state (Health and Human Services Food and Drug Branch) organization that has the power to provide services for conformity assessment on the conditions set out in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and United States Code (U.S.C) as part for the sale of medical device products. This normally means assessing the manufacturers conformity to the essential requirements listed in each directive. 

		
	2.8
	 “Lot” or “Batch” means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

		
	2.9
	“Label” means a display of written, printed, or graphic matter upon the immediate container of any article.  Any word, statement, or other information appearing on the immediate container must also appear “on the outside container or wrapper, if any there be, of the retain package of such article, or is easily legible through the outside container of wrapper.”

		
	2.10
	“Labeling” means any  Labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) displaying such article” at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.

		
	2.11
	 “Quality Records” means Documents containing recorded information, regardless of the medium or characteristic, which demonstrate the effectiveness of the quality management system and that provide evidence that products meet regulatory requirements and comply with specified product requirements.

		
	2.12
	“Removal” means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.

		
	2.13
	“Stock Recovery” means the correction or removal of a device that has not been marketed or that has not left the direct control of the manufacturer, i.e., the device is located on the premises owned, or under the control of, the 

[*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.

manufacturer, and no portion of the lot, model, code, or other relevant unit involved in the corrective or removal action has been released for sale or use.
		
	2.14
	"Recall" means when there is a risk of death or serious deterioration to the state of health, the return of a medical device to the supplier, its modification by the supplier at the site of installation, its exchange or its destruction, in accordance with the instructions contained in the advisory notice.

		
	2.15
	"Medical Device Reporting System" is a system of incident reporting to the Federal Food and Drug Administration (FDA), for all medical devices which are approved for inter-state commerce, where such incidents lead to corrective action relevant to medical devices.  Medical Device Reporting Systems maintained by the Distributor shall comply with all applicable laws, the rules and regulations promulgated by the Federal or any State. This system is intended to allow data to be correlated between the FDA and manufactures to improve the protection of health and safety of patients, users and others by reducing the likelihood of the same type of adverse incident being repeated in different places at different times. 

		
	3.0
	PROCESS CONTROLS

		
	3.1
	Both parties shall be responsible for all process control activities relative to the Products, including but not limited to, assurance of receipt, identification, traceability, storage, handling, inventory control, contamination control, complaint handling and trending and process validations, as required by Title 21 of United States Code of Federal Regulations, and other applicable regulations, and governmental laws.

		
	3.2
	Both parties shall maintain appropriate documented procedures.

		
	3.3
	Company shall provide evidence that packaging containers maintain the integrity, quality, function, and sterility of the product for the entire shelf life, and not produce toxic residues during storage.  Packaging must prevent or indicate the occurrence of tampering.

		
	4.0
	TRAINING AND DOCUMENT CHANGE CONTROL

		
	4.1
	Distributor shall be responsible for managing an effective employee training program and document change control system relative to the receipt, identification, traceability, storage, handling, inventory control, contamination control and complaint handling and trending at the location of Distributor and its third party suppliers.

		
	4.2
	Distributor must train its employees to perform their job function and to this Quality Agreement as required.

		
	5.0
	VALIDATION

		
	5.1
	Distributor shall be responsible for managing qualified processes and systems as required of suppliers (e.g. computer system) by law.

[*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.

		
	5.2
	Both parties shall be responsible for managing an effective product and process validation system relative to the distribution of the Products at the location of the Distributor and its third party suppliers.

		
	5.3
	Both parties shall develop and implement validation or qualification protocols for significant processes, equipment, and computer systems.

		
	5.4
	Company shall be responsible for managing an effective product and process validation system relative to the manufacture of the Products at the location of the Company and its third party suppliers.

		
	6.0
	DISTRIBUTION AND HANDLING

		
	6.1
	Products shipped by the Distributor must be shipped using documented procedures for the handling, storage, packaging, preservation, and delivery of the Products.  

		
	6.2
	Distributor shall deliver Products to its customers using documented procedures for handling, storage, packing, preservation, and delivery of the Products.

		
	6.3
	Disposables must have at least three months of expiration dating left, unless specific variance by lot number has been agreed to by both parties, before being shipped to any end-user customer.  

		
	6.4
	The Distributor will not modify any product packaging that it receives from the Company.  Shipping containers shall be validated to ensure that the safety and integrity of the Product is maintained during transit, including shipping methods that conform with the Product’s acceptable temperature and humidity ranges.

		
	6.5
	Distributor must maintain storage & handling as follows:

Seven Plus Product
	
			
	Product Name
	Storage Temperature
	Humidity

	Sensor
	2-25°C (36-77°F)
	N/A

	Transmitter
	0-45°C (32-113°F)
	Max 95% Relative

	Receiver
	0-45°C (32-113°F)
	10-85% Relative

    
G4 Platinum Product
	
			
	Product Name
	Storage Temperature
	Humidity

	Sensor
	2-25°C (36-77°F)
	0-95% Relative

	Transmitter
	0-45°C (32-113°F)
	10-95% Relative

	Receiver
	0-45°C (32-113°F)
	10-95% Relative

G4 Platinum Product - Pediatric

[*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.

	
			
	Product Name
	Storage Temperature
	Humidity

	Sensor
	2-25°C (36-77°F)
	0-95% Relative

	Transmitter
	0-45°C (32-113°F)
	10-95% Relative

	Receiver
	0-45°C (32-113°F)
	10-95% Relative

		
	7.0
	LOT TRACEABILITY

		
	7.1
	Distributor shall establish and maintain procedures for identifying the Products by suitable means from receipt and during all stages of production and delivery.  This shall include procedures to provide full lot traceability for each unit, lot, or batch of finished Products during all stages of production and delivery to the Distributor.  

		
	7.2
	Distributor shall establish and maintain procedures to provide traceability to the first consignee.

		
	7.3
	Distributor shall establish and maintain procedures to provide traceability to the end user.

		
	7.4
	Both parties shall use reasonable efforts to assist the other in maintaining respective lot traceability.

		
	7.5
	Both parties are required to track the following information detailed in the table to the end user. 

		
	8.0
	Seven Plus Product

	
			
	Product
	Description
	Lot traceability Tracking Requirement

	STK-7U-030
	SEVEN PLUS System Kit
	Lot Number identified on the box

	STS-7K-041
	SEVEN Sensors (package of one (1) or four (4))
	Lot Number identified on the box

	STR-7U- 030
	SEVEN PLUS Replacement Receiver
	Lot Number identified on the box

	STT-7U- 030
	SEVEN PLUS Replacement Transmitter
	Lot Number identified on the box

		
	9.0
	G4 Platinum Product

[*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.

	
			
	Product
	Description
	Lot traceability Tracking Requirement

	STK-GL-001
	G4 Platinum Receiver Kit – BLK
	Lot Number identified on the box

	STK-GL-PNK
	G4 Platinum Receiver Kit – PNK
	Lot Number identified on the box

	STK-GL-BLU
	G4 Platinum Receiver Kit – BLU
	Lot Number identified on the box

	STT-GL-003
	G4 Transmitter Kit
	Lot Number identified on the box

	STR-GL-001
	G4 Platinum Replacement Receiver Kit – BLK
	Lot Number identified on the box

	STR-GL-PNK
	G4 Platinum Replacement Receiver Kit – PNK
	Lot Number identified on the box

	STR-GL-BLU
	G4 Platinum Replacement Receiver Kit – BLU
	Lot Number identified on the box

	STS-GL-011
	G4 Platinum Sensors Kit (package of one (1))
	Lot Number identified on the box

	STS-GL-041
	G4 Platinum Sensors Kit (package of four (4))
	Lot Number identified on the box

		
	10.0
	G4 Platinum Product - Pediatric

	
			
	Product
	Description
	Lot traceability Tracking Requirement

	STK-KD-001
	G4 Platinum Pediatric Receiver Kit – BLK
	Lot Number identified on the box

	STK-KD-PNK
	G4 Platinum Pediatric Receiver Kit – PNK
	Lot Number identified on the box

	STK-KD-BLU
	G4 Platinum Pediatric Receiver Kit – BLU
	Lot Number identified on the box

	STT-GL-003
	G4 Transmitter Kit
	Lot Number identified on the box

	STR-KD-001
	G4 Platinum Replacement Receiver Kit – BLK
	Lot Number identified on the box

	STR-KD-PNK
	G4 Platinum Replacement Receiver Kit – PNK
	Lot Number identified on the box

	STR-KD-BLU
	G4 Platinum Replacement Receiver Kit – BLU
	Lot Number identified on the box

	STS-GL-011
	G4 Platinum Sensors Kit (package of one (1))
	Lot Number identified on the box

	STS-GL-041
	G4 Platinum Sensors Kit (package of four (4))
	Lot Number identified on the box

		
	11.0
	PACKAGING AND LABELING

[*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.

		
	11.1
	Company shall provide packaging and labeling specifications that call out clear labeling requirements. 

		
	11.2
	Company shall ensure that the labels, inserts and accompanying documentation satisfy the requirements of the applicable regulations.

		
	11.3
	Distributor shall not modify the labels, primary or secondary packaging, inserts or accompanying documentation without the written approval of the Company.

		
	12.0
	 FINISHED PRODUCT NON-CONFORMANCES

		
	12.1
	Any nonconforming finished product requires written approval from Company’s Quality Assurance before shipment to any Customer by Distributor. 

		
	13.0
	COMPLAINT HANDLING AND REPORTING

		
	13.1
	Distributor shall be responsible for the establishment and maintenance of a system for handling all Tier I Complaints pertaining to Products distributed under the Agreement.  "Complaint" means any written, electronic, telephone call and/or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released to distribution.  A complaint is any indication of the failure of a device to meet customer or user expectations for quality or to meet performance specifications.  A “Tier I Complaint” includes complaints that pertain to the purchase, payment, billing, delivery, packaging and customer service.  This system shall include receipt, review, corrective/preventative action and maintenance of files.  Distributor will not perform any Tier II Complaint Handling, as defined below.  

		
	13.2
	Company shall be responsible for the establishment and maintenance of a system for handling Tier II Complaints pertaining to Products distributed under the Agreement.  A “Tier II Complaint” includes complaints that pertain to product functionality, trouble shooting, or adverse events.  This system shall include receipt, review, investigation, corrective/preventative action and maintenance of files.  It shall also include adverse event reporting to the appropriate governmental authorities as required by regulations in the applicable jurisdictions.

		
	13.3
	Company shall notify Distributor in writing of legal and regulatory matters relating to the Products, including:

		
	13.3.1
	Any regulatory actions by governmental authorities (e.g., inspection citations, warning letters, or other non-conformance notices).

		
	13.3.2
	Regulatory enforcement actions such as injunctions or seizures.

[*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.

		
	13.3.3
	FDA registration activity (e.g., non-conformance notices, hold points).

		
	13.3.4
	Complaints received from Customers within the Territory that have not been processed through the Company’s complaint handling system.

		
	13.3.5
	Adverse incidents relating to customers within the Territory (e.g., MDR’s.).

		
	13.4
	Distributor shall notify Company in writing of the following:

		
	13.4.1
	Any serious regulatory action relating to the Products.

		
	13.4.2
	Tier I Complaints regarding Products or Instruments. Distributor shall code, trend and report monthly all phone call inquiries and Tier I Complaint data pertaining to Products.  

		
	13.4.3
	If an adverse incident is received that may be subject to FDA’s Medical Device Reporting regulation that pertain to Products and Instruments, then Distributor shall notify Company  no later than 24 hours following Distributor’s initial receipt of the adverse event.

		
	13.4.4
	  Distributor shall forward all complaints pertaining to Products and Instruments to Company no later than 5 working days following Distributor’s initial receipt of the complaint.

		
	14.0
	FIELD ACTIONS

		
	14.1
	The Company will be responsible for the initiation of any recalls or other field actions related to the Products.

		
	14.2
	Both parties will comply with recalls or general corrective actions, provided such recalls or general corrective actions do not, in the opinion of Company violate or cause Company to violate the laws of any jurisdiction affected by the recalls or corrective action.

		
	14.3
	If Distributor and Company do not agree on a course of action, Company may initiate field actions related to the Products, but may not use field action to cause Distributor to lose Customers. 

		
	15.0
	AUDITS

		
	15.1
	  Company shall have the right to conduct audits of Distributor’s facilities and operations during normal business hours at its own expense and upon thirty (30) days notice to Distributor in order to assess compliance with all applicable regulations, procedures and this Quality Agreement.  Any such audits will be conducted by a national “big four” independent accounting firm (or other independent accounting firm whose audit department is a separate stand alone function of its business and which possesses liability insurance with coverage of at least [****]), subject to such firm’s execution of a confidentiality agreement in form reasonably acceptable to Distributor. Company shall be permitted to conduct one audit per calendar year or more frequently in the 

[*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.

instance there exists a material difference between the inventory records of Distributor and Company.
		
	16.0
	RECORD RETENTION

		
	16.1
	Both parties shall retain all sales and medical records as required by law.  

		
	16.2
	Prior to any record destruction pertaining to Company Products and Instruments, the Distributor will notify the Company in writing.  If the record destruction is not approved the Company will assume responsibility of the records.

		
	17.0
	REGULATORY AND REGISTRATION ADMINISTRATION

		
	17.1
	Distributor, at its expense, is responsible for registration responsibilities, and for agreed upon domestic registration costs in accordance with Federal and State regulations.  Distributor shall provide sufficient data and information to support domestic registrations.

		
	17.2
	Company, at its expense, is responsible for registration responsibilities, and for agreed upon registration costs of Products in the Territory.  Company shall provide sufficient data and information to support such registrations.

		
	18.0
	QUALITY SYSTEM COMPLIANCE

		
	18.1
	Distributor shall establish and maintain a quality system in compliance with Title 21, United States Code of Federal Regulations and other applicable regulations, and governmental laws. Distributor shall also ensure that its contract vendors maintain a quality system in compliance with current Title 21, United States Code of Federal Regulations and other applicable regulations, and governmental laws.

		
	18.2
	Distributor acknowledges that without registering as an out-of-state home medical device retail facility, an out-of-state home medical device retail facility shall not sell or distribute prescription devices in this state through any person or media other than a wholesaler who is licensed pursuant to Chapter 9 (commencing with Section 4000) of Division 2 of the California Business and Professions Code.  

		
	19.0
	ADDITIONAL DISTRIBUTOR REQUIREMENTS

		
	19.1
	Distributor agrees to comply with all applicable laws and regulations. Distributor agrees to obtain the necessary licenses to meet its obligations under this agreement.

		
	19.2
	Records should be accurate, indelible and legible. Entries must be dated and the person performing a documented task must be identified. Records must provide a complete history of the work performed. Products identified in this Quality Agreement are not in conflict with the laws of the importing country.

[*****] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS AND ASTERISKS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED INFORMATION.

4.   All other terms and conditions of the Agreement shall remain in full force and effect.  

IN WITNESS WHEREOF, authorized representatives of the parties have executed this Amendment Number Two as of date first set out above.

Signed by:    /s/ Jess Roper            
Jess Roper
Title:      V.P. and Chief Financial Officer

for and on behalf of
DexCom, Inc.

Signed by:    /s/ Adam Graybill            
Name: 
Title:          

for and on behalf of 
__RGH Enterprises________________________

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