Document:

EX-10.5

 Exhibit 10.5 
  

 
 Supplier Quality Agreement 

Between 
 SI BONE, Inc.

 and 
 Orchid
Bio-Coat 

 000725-F02 Rev A 
  

 Contents 
  

							
	 1.    ADMINISTRATIVE ELEMENTS
	  	 	4	  
			
	 1.1.
	 	 Scope
	  	 	4	  
			
	 1.2.
	 	 Parties to the Agreement
	  	 	4	  
			
	 1.3.
	 	 Definitions, Abbreviations, and Acronyms
	  	 	4	  
			
	 1.4.
	 	 Referenced Documents
	  	 	5	  
			
	 1.5.
	 	 Products and Services Covered By This Agreement
	  	 	5	  
			
	 1.6.
	 	 Site(s) Involved
	  	 	6	  
			
	 1.7.
	 	 Quality Management Systems
	  	 	6	  
			
	 1.8.
	 	 Use of Third Parties
	  	 	7	  
			
	 1.9.
	 	 Supplier Selected
	  	 	7	  
			
	 1.10.
	 	 Term of Agreement
	  	 	8	  
			
	 1.11.
	 	 Assignment
	  	 	8	  
		
	 2.    COMPLIANCE
	  	 	8	  
			
	 2.1.
	 	 Specifications
	  	 	8	  
			
	 2.2.
	 	 Specification Changes
	  	 	8	  
			
	 2.3.
	 	 Activity by Regulators, Notified Bodies, or Certification Bodies
	  	 	8	  
			
	 2.4.
	 	 Third Party Quality Agreements
	  	 	9	  
		
	 3.    MANUFACTURING, PACKAGING, AND LABELING
	  	 	9	  
			
	 3.1.
	 	 Environmental Control
	  	 	9	  
			
	 3.2.
	 	 Personnel
	  	 	9	  
			
	 3.3.
	 	 Equipment
	  	 	9	  
			
	 3.4.
	 	 Automated Processes
	  	 	9	  
			
	 3.5.
	 	 Inspection, measuring, and test equipment
	  	 	9	  
			
	 3.6.
	 	 Process Validation
	  	 	10	  
			
	 3.7.
	 	 Calibration
	  	 	10	  
			
	 3.8.
	 	 Labeling Operations
	  	 	10	  
			
	 3.9.
	 	 Packaging Operations
	  	 	10	  
		
	 4.    DOCUMENTATION AND RECORDS
	  	 	10	  
			
	 4.1.
	 	 Device History Record
	  	 	10	  
			
	 4.2.
	 	 Record Retention
	  	 	11	  

  
 Page 2 of 18 

 000725-F02 Rev A 
  

							
	 5.    STORAGE AND SHIPMENT
	  	 	11	  
			
	 5.1.
	 	 Storage
	  	 	11	  
			
	 5.2.
	 	 Shipment
	  	 	11	  
		
	 6.    CHANGE CONTROL
	  	 	11	  
			
	 6.1.
	 	 Change Requests
	  	 	11	  
			
	 6.2.
	 	 Deviations
	  	 	12	  
			
	 6.3.
	 	 Other Changes
	  	 	12	  
		
	 7.    NON-CONFORMANCE, CAPA, AND COMPLAINTS
	  	 	12	  
			
	 7.1.
	 	 Disposition of Non-conforming Material
	  	 	12	  
			
	 7.2.
	 	 Rework
	  	 	12	  
			
	 7.3.
	 	 Corrective Action
	  	 	12	  
			
	 7.4.
	 	 Complaints
	  	 	13	  
			
	 7.5.
	 	 Medical Device Reports
	  	 	13	  
			
	 7.6.
	 	 Corrections and Removals
	  	 	13	  
		
	 8.    AUDITS
	  	 	13	  
			
	 8.1.
	 	 Customer Audits of Supplier Facilities
	  	 	13	  
			
	 8.2.
	 	 Customer Audit Findings
	  	 	14	  
			
	 8.3.
	 	 Auditing Third Party Suppliers
	  	 	14	  
		
	 Appendix 1
	  	 	15	  
		
	 Appendix 2
	  	 	16	  
		
	 Appendix 3
	  	 	17	  
		
	 Appendix 4
	  	 	18	  

  
 Page 3 of 18 

 000725-F02 Rev A 
  

	1.	ADMINISTRATIVE ELEMENTS 

  

	 	1.1.	Scope 

 This agreement defines the Quality Agreement between the parties identified
below. It defines the commitment both parties make to ensure that their respective products and services satisfy the quality and regulatory requirements called out in this agreement. Both parties agree to cooperate in the success of this agreement.
This agreement does not define the forecasting, ordering, delivery, or pricing requirements for either party. This agreement does not define the specifications for the products or services covered. 

 

	 	1.2.	Parties to the Agreement 

 This Quality Agreement is executed between Orchid
Bio-Coat with business address at 21613 Bridge Street Southfield Michigan 48034, hereafter referred to as <Supplier> and SI-BONE, Inc. with business address at 3055 Olin Ave., Suite 2200, San Jose, CA 95128, hereafter referred to as
“SI BONE”. <Supplier> agrees to provide the goods or services defined below in full conformance with the requirements of this agreement. 
  

	 	1.3.	Definitions, Abbreviations, and Acronyms 

 The following terms are included in this
agreement. 
 Accuracy – A statement of how close a measured value is to the actual (true) value. See also, Precision. 

Complaint – A written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability,
reliability, safety, effectiveness, or performance of a device after it is released for distribution. 
 Concession – Permission
to use or release material that does not conform to specified requirements. A concession is frequently called a Use-As-Is (UAI) disposition. 

Corrective Action – Action to eliminate the cause of a detected nonconformity or other undesirable situation 

Directed Procurement – A case in which the Customer directs the Supplier to obtain a good or service from a particular third
party. In a directed procurement, the Customer is responsible for product qualification, Supplier qualification, etc. The Supplier should track and report the third party’s performance metrics to the Customer. 

FIFO – First In, First Out 

IM&TE – Inspection, measuring, and test equipment 

Precision – A statement of the repeatability of a measure. See also, accuracy. 

Product – Product is the output of a process and includes, but is not limited to, goods, services, software, documentation, and
consulting. 
 Promptly – Unless specified otherwise, promptly means within ten working days. 

QMS – Quality Management System 

Repair – Action on nonconforming material to make it acceptable for the intended use 

Rework – Action on nonconforming material to make it conform to the requirements 

RMS – Risk Management System 

Scrap – Action on nonconforming material to preclude its originally intended use 

Supplier – The Supplier delivers product to the Customer. The term Supplier includes, but is not limited to, contractors,
consultants, sister organizations, and parent organizations. 

  
 Page 4 of 18 

 000725-F02 Rev A 
  

	 	1.4.	Referenced Documents 

 21 CFR Part 820 – Quality System Regulation 

IS0 13485:2003 – Quality management systems – Requirements for regulatory purposes 

ISO 14971:2009 – Application of risk management to medical Devices 

Medical Device Directive (MDD) - 93/42/EEC 

GHTF/SG3/N15R8 – Implementation of risk management principles and activities within a Quality Management System 

GHTF/SG3/N17:2008 Quality Management System – Guidance on the Control of Products and Services Obtained from Suppliers 

 

	 	1.5.	Products and Services Covered By This Agreement 

 This agreement pertains to the
products listed in the table below. 
  

			
	 Part Number
	  	 Description

	4030-90	  	iFuse Implant, 4x30mm
	4035-90	  	iFuse Implant, 4x35mm
	4040-90	  	iFuse Implant, 4x40mm
	4045-90	  	iFuse Implant, 4x45mm
	4050-90	  	iFuse Implant, 4x50mm
	4055-90	  	iFuse Implant, 4x55mm
	4060-90	  	iFuse Implant, 4x60mm
	4065-90	  	iFuse Implant, 4x65mm
	4070-90	  	iFuse Implant, 4x70mm
	7030-90	  	iFuse Implant, 7x30mm
	7035-90	  	iFuse Implant, 7x35mm
	7040-90	  	iFuse Implant, 7x40mm
	7045-90	  	iFuse Implant, 7x45mm
	7050-90	  	iFuse Implant, 7x50mm
	7055-90	  	iFuse Implant, 7x55mm
	7060-90	  	iFuse Implant, 7x60mm
	7065-90	  	iFuse Implant, 7x65mm
	7070-90	  	iFuse Implant, 7x70mm
	7xxx	  	7071-7210 mm implant

  
 Page 5 of 18 

 000725-F02 Rev A 
  

	 	1.6.	Site(s) Involved 

 The Supplier produces the product at any of the sites listed below.
The Supplier ships the product to the Customer from any of the sites listed below. 
 Supplier Production Sites: 

Orchid Bio-Coat, 21316 Bridge Street Southfield Michigan 48034 

Customer Receiving Sites: 

SI-BONE, Inc. 3055 Olin Ave., Suite 2200, San Jose, CA 95128 
  

	 	1.7.	Quality Management Systems 

 Quality System Regulation 

The Supplier and the Customer shall each maintain a Quality Management System (QMS) that conforms to the requirements of the FDA’s
Quality System Regulation (QSR) as stated in 21 CFR Part 820. Should the Supplier determine that a requirement of 21 CFR Part 820 is not appropriate or not applicable to the product delivered, the Supplier shall notify the Customer within thirty
days of making that determination. The list of agreed not appropriate or not applicable requirements is shown in Appendix 1. 
 ISO
13485:2003 
 The Supplier and Customer shall each maintain a Quality Management System (QMS) that conforms to the requirements of
ISO 13485:2003. The Supplier shall register the QMS with a registrar acceptable to the Customer. The Supplier shall provide a copy of the registration certificate to the Customer. Should the Supplier determine that a requirement of ISO 13485:2003 is
not appropriate or not applicable to the product delivered, the Supplier shall notify the Customer within thirty days of making that determination. The list of agreed not appropriate or not applicable requirements is shown in Appendix 2. 

ISO 14971:2007 

The Supplier and the Customer shall each maintain a Risk Management System that conforms to the requirements of ISO 14971:2007. In
addition, both the Supplier shall integrate the Risk Management System (RMS) into the Quality Management System (QMS) employing the principles in GHTF/SG3/N15R8. Should the Supplier determine that a requirement of ISO 14971:2007 is not appropriate
or not applicable to the product delivered, the Supplier shall notify the Customer within thirty days of making that determination. The list of agreed not appropriate or not applicable requirements is shown in Appendix 3. 

Medical Device Directive (MDD) - 93/42/EEC 

The Supplier and the Customer shall each maintain a Quality Management System (QMS) that conforms to the requirements of the MDD as stated in
3.2 of the MDD. Should the Supplier determine that a requirement of the MDD is not appropriate or not applicable to the product delivered, the Supplier shall notify the Customer within thirty days of making that determination. The list of agreed not
appropriate or not applicable requirements is shown in Appendix 4. 

  
 Page 6 of 18 

 000725-F02 Rev A 
  

 Exclusion to Required Standards 

The Supplier shall produce products in accordance with the requirements of the standards listed. Should the Supplier determine that a
requirement of a listed standard is not appropriate or not applicable to the product delivered, the Supplier shall notify the Customer within thirty days of making that determination. The list of agreed exclusions is also shown below. 

Standard Title Exclusions: 
  

	 	1.8.	Use of Third Parties 

 Directed Procurement 

The Customer has qualified the Third Party Suppliers in the following table to provide the goods or services listed. For the purposes of this
agreement, the Supplier does not have to qualify these Third Party Suppliers. 
 Third Party Suppliers – Directed Procurement: 

Supplier Product or Service: 

Sterilization Service 
 When
used on, applied to, or incorporated into the product provided to the Customer, the Supplier shall purchase the listed goods or services from the designated Third Party Supplier. 

The Supplier shall provide the Customer with monthly performance reports on these Third Party Suppliers that includes the number of purchase
order lines placed with the Third Party Supplier, the percentage of shipments received late, and the percentage of shipments rejected at receiving acceptance (21 CFR §820.80(b) or ISO 13485:2003 Clause 7.4.3). 

 

	 	1.9.	Supplier Selected 

 If the Supplier uses a Third Party Supplier, other than directed
procurement, to manufacture, package, label, test, or release product provided to the Customer, the role of the Third Party Supplier is identified in the table below. In selecting Third Party Suppliers, the Supplier shall apply the requirements of
21 CFR §820.50 and ISO 13485:2003 Clause 7.4. In addition, the Supplier shall apply the principles in GHTF/SG3/N17:2008. 
 Third Party
Suppliers: 
 Supplier Product or Service QMS Applied: 

  
 Page 7 of 18 

 000725-F02 Rev A 
  

	 	1.10.	Term of Agreement 

 This Agreement shall become effective and binding upon the date of
the final signature and shall remain in effect until 2 years after the last delivery of any product by the Supplier to the Customer, unless the Customer specifically requests an extension of the Agreement. Either party may terminate this Agreement
by giving 6 months written notice to the other party. 
  

	 	1.11.	Assignment 

 Neither party shall have the right to assign any or all of its rights or
obligations under this agreement without the other party’s prior written consent, which shall not unreasonably be withheld. The foregoing notwithstanding, prior written consent shall not be required in connection with a merger, consolidation,
or a sale of all or substantially all of party’s assets to a third party, except if such merger, consolidation or sale is with a competitor of the other party. 
  

	2.	COMPLIANCE 

  

	 	2.1.	Specifications 

 The Customer shall define the specifications for the product the
Supplier provides. This could take many forms including drawings, reference to commercial specifications, identification of brand names, and standards. The specifications may be paper documents, electronic documents or other appropriate media. The
Supplier undertakes to deliver product in full conformance to the agreed specifications. 
  

	 	2.2.	Specification Changes 

 Changes to specifications are made by mutual agreement between
the Supplier and the Customer. In addition to agreement of the change, the Supplier and Customer will determine the effectivity date of the change. When the specifications include references to brand names, the Supplier and Customer will mutually
agree on the implementation of any changes made in the brand name product. 
  

	 	2.3.	Activity by Regulators, Notified Bodies, or Certification Bodies 

 The Supplier shall
promptly notify the Customer of any inspections, audits, formal visits, etc. of any regulator, notified body, or certification body acting in a formal capacity. In the US this includes, but is not limited to the Food and Drug Administration, the
Environmental Protection Agency, and the Occupational Safety and Health Administration. It also includes corresponding State Agencies. Upon the Customer’s request, the Supplier shall disclose the results of any inspections or audits and the
associated cause and corrective action. The Supplier shall promptly notify the Customer of any inspection or audit findings that impact the safety, effectiveness, conformity, or availability of product the Supplier provides to the Customer. 

 

	 	2.4.	Third Party Quality Agreements 

 The Supplier shall have a Quality Agreement with Third
Party Suppliers used for production, packaging, testing, processing, or release. Upon the Customer’s request, the Supplier will provide a copy of the Quality Agreement. 

  
 Page 8 of 18 

 000725-F02 Rev A 
  

	3.	MANUFACTURING, PACKAGING, AND LABELING 

  

	 	3.1.	Environmental Control 

 If environmental conditions could reasonably be expected to have
an adverse effect on product quality, the Supplier shall establish and maintain procedures, including maintenance, adjustment, and inspection to adequately control these environmental conditions. The Supplier shall keep records of these activities
and make them available to the Customer upon request. 
  

	 	3.2.	Personnel 

 If contact between personnel and the product could reasonably be expected to
have an adverse effect on product quality, the Supplier shall establish and maintain requirements for the health, cleanliness, personal practices, and clothing of personnel to adequately control this contact. The Supplier shall keep records of these
activities and make them available to the Customer upon request. 
  

	 	3.3.	Equipment 

 The Supplier shall ensure that all equipment used in the manufacturing
process for product is appropriately designed, constructed, placed, and installed. The Supplier shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are
met. The Supplier shall keep records of these activities and make them available to the Customer upon request. 
  

	 	3.4.	Automated Processes 

 If the Supplier uses computers, software, or other automated
methods as part of the production process, the Supplier shall validate the computer software for its intended use. The validation process shall create a validation protocol (describing the planned activities) and a validation report documenting the
outcome of the planned activities). All software changes shall be similarly validated prior to use. The Supplier shall keep records of these activities and make them available to the Customer upon request. 

 

	 	3.5.	Inspection, measuring, and test equipment 

 The Supplier shall ensure that all
inspection, measuring, and test equipment (IM&TE) used in the manufacturing process for product is suitable for its intended purposes and is capable of producing valid results. Suitability includes limits for accuracy and precision. The Supplier
shall establish and maintain schedules for the calibration, adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Calibration standards used for IM&TE shall be traceable to national or
international standards. The Supplier shall keep records of these activities and make them available to the Customer upon request. 

  
 Page 9 of 18 

 000725-F02 Rev A 
  

	 	3.6.	Process Validation 

 If the output of a Supplier’s process is not fully verified by
subsequent inspection or test, the Supplier shall validate the process with a high degree of assurance, typically demonstrating a Cpk 3 1.33. 

The validation process shall create a validation protocol (describing the planned activities) and a validation report (documenting the outcome
of the planned activities). All validated process changes shall be similarly validated prior to use. The Supplier shall keep records of these activities and make them available to the Customer upon request. When the Supplier ships products produced
using a validated process, the Supplier shall include process documentation showing the date the process was operated, the name of the operator, the identity of major equipment used, the identity and calibration recall date of the IM&TE used in
the process, and the setting of each input process parameter. 
  

	 	3.7.	Calibration 

 The Supplier shall have an established process for calibration of
equipment used to manufacture the product. Records are available upon request. 
  

	 	3.8.	Labeling Operations 

 The Supplier shall control all labeling and packaging operations
to prevent labeling mix-ups. The Supplier shall keep records of these activities and make them available to the Customer upon request. 
  

	 	3.9.	Packaging Operations 

 The Supplier will pack and package the product using the agreed
methods or best practices to protect the product from deterioration or damage during processing, storage, handling, and shipment. The Supplier shall keep records of these activities and make them available to the Customer upon request. 

 

	4.	DOCUMENTATION AND RECORDS 

  

	 	4.1.	Device History Record 

 The Supplier and Customer will agree on which party maintains
selected portions of the Device History Record required by 21 CFR §820.181. This list also includes installation reports (21 CFR §820.170) and servicing reports (21 CFR §820.200). 

 

	 	•	 	Record Applicable Supplier Customer Specific Records 

  

	 	•	 	Device specifications 

  

	 	•	 	Production process specifications 

  

	 	•	 	Quality assurance procedures and specifications 

  

	 	•	 	Labeling specifications 

  

	 	•	 	Packaging specifications 

  

	 	•	 	Installation procedures and methods 

  

	 	•	 	Installation records 

  

	 	•	 	Maintenance procedures, methods, and Records 

  

	 	•	 	Servicing procedures, methods, and records 

  
 Page 10 of 18 

 000725-F02 Rev A 
  

 Upon the request of the Customer, the Supplier shall make all records available within two
working days. 
  

	 	4.2.	Record Retention 

 Records required by the agreed upon quality system will be maintained
for a period of 15 years after the last product has been manufactured. 
  

	5.	STORAGE AND SHIPMENT 

  

	 	5.1.	Storage 

 The Supplier shall establish and maintain procedures to control storage areas
and stock rooms to prevent mix-ups, damage, deterioration, contamination, or other adverse effects. The Supplier shall ensure that all products are stored to facilitate proper stock rotation and that product is retrieved from stock using First In,
First Out (FIFO) methodology. 
  

	 	5.2.	Shipment 

 The Supplier shall ship products to the Customer using agreed shipping
methods to prevent the damage or deterioration of the product. The shipment methods are summarized in the list below, but may be augmented by specified requirements and standards. 

Shipment Method Summary: 
  

	 	•	 	Product 

  

	 	•	 	Packaging 

  

	 	•	 	Handling 

  

	 	•	 	Carrier 

  

	 	•	 	Reusable Container 

 Reusable containers are initially purchased by the Customer and provided
to the Supplier as Customer owned material. 
 The Supplier will repair or replace damaged reusable containers as necessary to keep the
circulating stock at the agreed level. If the agreement is terminated, all reusable containers belong to the Customer. 
  

	6.	CHANGE CONTROL 

  

	 	6.1.	Change Requests 

 If the Supplier requests to change a document, specification, drawing,
etc. under the Customer’s control, the Supplier shall document the request including the specific change, the reason for the change, the benefit derived from approving the request, the loss incurred from disapproving the request, and the
anticipated lead time before the change is reflected in the product. The Customer shall promptly acknowledge receipt of each change request. The Customer shall make a decision to accept or reject the change within thirty days of acknowledging
receipt. For accepted changes, the Supplier and Customer will work together to develop a plan to implement the change. 

  
 Page 11 of 18 

 000725-F02 Rev A 
  

	 	6.2.	Deviations 

 If the Supplier needs to deviate from a document, specification, drawing,
etc. under the Customer’s control, the Supplier shall document the deviation request including the specific deviation, the reason for the deviation, and the period (time, lots, etc.) the deviation will be in effect. 

 

	 	6.3.	Other Changes 

 The Supplier shall promptly notify the Customer of changes, other than
those documented above, in the product or service so the Customer may determine whether the changes may affect the quality of a finished device. 
  

	7.	NON-CONFORMANCE, CAPA, AND COMPLAINTS 

  

	 	7.1.	Disposition of Non-conforming Material 

 The Supplier shall segregate, investigate, and
disposition all nonconforming material. The Supplier is authorized to make rework and scrap dispositions without Customer Authorization. Concession or repair dispositions require the Customer’s written authorization. If the Supplier requests
authorization for a repair or concession disposition, the Supplier shall document the disposition request including the inspection or test conducted, the actual results, and, if applicable, the proposed repair. The Supplier shall update the
production-monitoring portion of the ISO 14971 Risk Management File to include information on the nonconformity. 
  

	 	7.2.	Rework 

 If the Supplier needs to rework any product supplied to the Customer, a written
history of all rework and/or corrective actions needed shall accompany the product upon shipment to the Customer, either separately or in the form of a Corrective Action. 
  

	 	7.3.	Corrective Action 

 Supplier Initiated Corrective Action 

The Supplier shall initiate corrective action for all detected nonconforming material regardless of disposition. Corrective Action shall
include the following steps. 
  

	 	1)	Determining the cause(s) of nonconformity 

  

	 	2)	Evaluate the need for action to ensure the nonconformity doesn’t recur 

  

	 	3)	Determine the action needed to prevent recurrence 

  

	 	4)	Implement the action needed to prevent recurrence 

  

	 	5)	Review the effectiveness of the corrective action 

 The Supplier shall keep records of these
activities and make them available to the Customer upon request. 
 Customer Initiated Corrective Action 

The Customer may initiate corrective action for the Supplier when the Customer identifies a nonconformity after receipt of the Supplier’s
product. The Supplier shall initiate corrective action upon receipt of the Customer’s initiation. The Supplier’s Corrective Action shall include the following steps. 
  

	 	1)	Determining the cause(s) of nonconformity 

  

	 	2)	Evaluate the need for action to ensure the nonconformity doesn’t recur 

  
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 000725-F02 Rev A 
  

	 	3)	Determine the action needed to prevent recurrence 

  

	 	4)	Implement the action needed to prevent recurrence 

  

	 	5)	Review the effectiveness of the corrective action 

 The Supplier shall report the results of
the corrective action to the Customer within 15 working days of initiation. The Supplier shall keep records of these activities and make them available to the Customer upon request. 

 

	 	7.4.	Complaints 

 Supplier Received Complaints 

If the Supplier receives a complaint related to the product, or any similar product, the Supplier provides to the Customer, the Supplier shall
promptly notify the Customer. The Customer will enter the complaint into the Customer’s Complaint Management System (21 CFR §820.198) and review and evaluate the complaint to determine whether an investigation is necessary. The Customer
will notify the Supplier of the decision to investigate or not. If the Customer requires the Supplier’s assistance in the investigation, the Customer will follow the Customer Initiated Corrective Action described above. 

Customer Received Complaints 

If the Customer receives a complaint related to the product the Customer supplies, the Customer will enter the complaint into the
Customer’s Complaint Management System (21 CFR §820.198) and review and evaluate the complaint to determine whether an investigation is necessary. If the Customer requires the Supplier’s assistance in the investigation, the Customer
will follow the Customer Initiated Corrective Action described above. 
  

	 	7.5.	Medical Device Reports 

 If the Supplier files a Medical Device Report for the product,
or any similar product, the Supplier provides to the Customer, the Supplier shall promptly notify the Customer. The Supplier and the Customer shall cooperate in the exchange of information required to effectively manage the Supplier’s medical
device report in the Customer’s Medical Device Event files. 
  

	 	7.6.	Corrections and Removals 

 If the Supplier files a Corrections or Removals for the
product, or any similar product, the Supplier provides to the Customer, the Supplier shall promptly notify the Customer. The Supplier and the Customer shall cooperate in the exchange of information required to effectively manage the Supplier’s
Correction or Removal Report in the Customer’s Corrections and Removals Records. 
  

	8.	AUDITS 

  

	 	8.1.	Customer Audits of Supplier Facilities 

 The Supplier shall allow the Customer, or its
authorized representative, to perform audits of the Supplier’s facilities, systems, documentation, and other requirements related to this agreement. Audits shall be conducted at mutually agreed dates and times. The Supplier and Customer will
agree upon methods to protect intellectual property such as confidentially agreements, non-disclosure agreements, etc. 

  
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 000725-F02 Rev A 
  

	 	8.2.	Customer Audit Findings 

 When conducting audits at the Supplier’s location, the
Customer will issue an Audit Report within five working days of the audit’s conclusion. The Supplier shall issue a plan to determine the correction, cause, and corrective action for each finding within thirty days of the Audit Report’s
issue date. 
  

	 	8.3.	Auditing Third Party Suppliers 

 The Supplier shall allow the Customer, or its
authorized representative, to perform audits of the Third Party Supplier’s facilities, systems, documentation, and other requirements related to this agreement. Audits shall be conducted at mutually agreed dates and times. The Supplier,
Customer, and Third Party Supplier will agree upon methods to protect intellectual property such as confidentially agreements, non-disclosure agreements, etc. 

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

  

							
	SI-BONE	  		 		 	
				
	Name	  	Title	 	Signature	 	Date
				
	Steve Ohara	  	Director of Quality	 	 /s/ Steve Ohara
	 	3/22/2013
	  
	  	  
	 	  
	 	  

				
	Orchid Bio-Coat	  		 		 	
				
	Name	  	Title	 	Signature	 	Date
				
	Robert J. Naumann	  	General Manager	 	 /s/ Robert J. Naumann
	 	12/18/12
	  
	  	  
	 	  
	 	  

  
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 000725-F02 Rev A 
  

 Appendix 1 

The list of agreed not appropriate or not applicable requirements from 21 CFR Part 820: None. 

  
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 Appendix 2 

The list of agreed not appropriate or not applicable requirements from ISO 13485:2003: None. 

  
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 Appendix 3 

The list of agreed not appropriate or not applicable requirements from ISO 14971:2007: None. 

  
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 Appendix 4 

The list of agreed not appropriate or not applicable requirements from Medical Device Directive (MDD) - 93/42/EEC: None. 

  
 Page 18 of 18EX-10.1

 Exhibit 10.1 
  

 
 September 14, 2018 

Scott Powell 
 75 State Street 

Boston, MA 02109 
 Dear Scott: 

This letter describes the understanding between you and Santander Holdings USA, Inc. (“SHUSA”) with respect to your service as CEO of SHUSA and Banco
Santander’s U.S. Country Head during the period January 1, 2018 – December 31, 2019. To the extent specifically described below, certain aspects of this arrangement will be subject to performance objectives and requirements
established by SHUSA and Banco Santander, S.A. (“Banco Santander” or the “Group”). Final annual compensation decisions will remain with the Group’s Remuneration Committee and its Board of Directors. The specific terms of
your responsibilities to Santander Consumer USA Holdings Inc., including its subsidiaries, (collectively, “SCUSA”) as its CEO, as well as the terms related to your SHUSA and overall U.S. responsibilities are set forth below. SHUSA, SCUSA
and the Group also may be individually or collectively referred to herein as “Santander.” 
 Time Allocation: 

At this juncture, one of our top priorities is the further improvement and development of SCUSA. Much work remains to be done there and we have determined that
a significant amount of your time should be dedicated to accomplishing this task, including in connection with your SCUSA CEO role. We anticipate that the majority of your time will be spent on SCUSA matters in
2018-19 and we recognize that, given the magnitude of the task at SCUSA, you could spend, on average during this period, as much as 80% of your time on SCUSA matters. This percentage of time devoted to SCUSA
is acceptable and, in fact, should serve as a guideline for how to prioritize your time and efforts and as a reference point for the significance the Group and SHUSA accord to improving SCUSA. However, we defer to you with respect to the precise
allocation of your time, including with respect to how you divide your time among Santander offices and locations. 
 Your non SCUSA-specific time will be
spent overseeing Banco Santander, SA’s (the “Group’s”) U.S. operations and activities overall, managing SHUSA and supervising its senior executives and the CEOs of the other SHUSA subsidiaries. Your top two SHUSA objectives will
be continued regulatory improvement (specific measures of which will be incorporated into your performance objectives, recognizing the need to ensure the confidentiality of confidential supervisory information) and financial performance
(meeting/exceeding budgets as set forth in the SHUSA 2018/2019 plan and approved by the Group). 
 Relationship with Subsidiary CEOs: 

Given the anticipated allocation of time towards your role at SCUSA, we anticipate that you will delegate even more to your senior SHUSA executives, including
the CEOs of SHUSA subsidiaries. We are looking to you to exercise your supervisory responsibilities while helping your executives develop to their maximum potential. As part of your supervisory responsibilities and in your oversight role as the
Group’s U.S. Country Head, you will take all reasonable steps to ensure that the CEOs of the SHUSA subsidiaries, and the other SHUSA executives, achieve SHUSA’s and Group goals in the U.S. This is a key motivating factor for the increase
in your targeted compensation. 

  
 1 

 

 
  

 Position(s), Term &
Location:                 
  

	 	•	 	 You will continue your employment as the CEO of SHUSA and as the Group’s U.S. Country Head, and CEO of
SCUSA. 

  

	 	•	 	 Your principal office will be located at the Santander US headquarters at 75 State Street, Boston, MA and all
travel and lodging to any other office location will be for the convenience of SHUSA, the Group and SCUSA. SCUSA and SHUSA shall fully indemnify you in the unlikely event that any tax is imposed or imputed with respect to your travel to and/or from,
or your lodging at, any location other than Boston, MA. 

 Compensation/Incentive Plan: 

 

	 	•	 	 Effective January 1, 2018, your annual base salary will be $3,000,000.00; paid bi-weekly on Fridays at a rate of $115,384.61, less all applicable federal, state and local taxes and other authorized payroll withholdings. This is an exempt position and is not eligible for overtime.

  

	 	•	 	 During your employment in these roles, you will be eligible to participate in the SHUSA Executive Bonus Plan.
Pursuant to the terms of the SHUSA Executive Bonus Plan, your 2018 performance year annual discretionary bonus target will be $4,250,000.00, of which a portion (which will be consistent with the portion applicable to other similarly situated
executives) may be deferred (your “Deferred Bonus”) and may be paid in cash, SAN ADRs and/or SCUSA shares. 

  

	 	•	 	 The amount of your entire bonus under the SHUSA Executive Bonus Plan shall be determined at the sole discretion
of Santander Group based the recommendation of the SCUSA Board Compensation Committee (“SCUSA BCC”) and the SHUSA Board Compensation & Talent Management Committee (“SHUSA BCTMC”). These recommendations will be based on
factors including, but not limited to, the weighting of your goals applicable to each entity, the level of your individual performance, the overall performance of SCUSA, the broader performance of SHUSA, Banco Santander, S.A. (“Banco
Santander”) and each of their respective wholly- or majority-owned subsidiaries; provided, however, that you must be in “active working status” at the time of any bonus payment (which shall be no later than March 15 of the year
following the year to which the bonus relates for the portion of the bonus that is not deferred). In no event, however, may any other categories of bonuses, awards, or compensation to which you are entitled be taken into account in determining the
amount of your bonus under the SHUSA Executive Bonus Plan (your “SHUSA Bonus”). 

  

	 	•	 	 You will continue to participate in the Special Regulatory Incentive Program (“SRIP”) at your initial
targeted discretionary award value of $2,000,000.00. As you know, 25% of this award was achieved in 2017 and paid in Q1 2018, and the remaining 75% of this total targeted amount remains at risk subject to the payment provisions described in the
following paragraph. 

  

	 	•	 	 Both your Deferred Bonus and the remaining payouts made under the SRIP (together, your “Deferred Variable
Compensation”) shall be paid in accordance with CRD-IV as described below. 

  

	 	•	 	 As noted above, in order to be eligible for any performance year annual discretionary bonus(es), you must be in
“active working status” at the time of the respective bonus payment. All annual discretionary bonus payments are subject to the terms and conditions of the SHUSA Executive Bonus Plan and are further subject to all applicable tax
withholdings. For purposes of this letter, “active working status” means that you have not resigned (or given notice of your intention to resign), and your employment has not been terminated (nor have you been given notice of your
termination). Furthermore, except as otherwise provided herein, pro-rated annual discretionary bonuses will not be paid to an employee who resigns or whose employment is terminated during the applicable
performance year. 

  
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 Identified Staff (CRD-IV): 

 

	 	•	 	 Your role is determined to be “Identified Staff” (under the European Union’s Capital Requirements
Directives, Directive 2013/36/EU (“CRD IV”)). CRD IV is part of the European regulations regarding compensation (remuneration) in financial entities. The implementation of CRD IV in Spain provides that categories of staff whose
professional activities have a significant impact on the risk profile of the entity or its group will be designated as Identified Staff. These employees are subject to specific regulations regarding variable remuneration. Santander must verify
compliance with these regulations, through European Central Bank at the corporate level and also through local supervisors at all of its entities. Therefore, it is necessary to continuously maintain and update this Identified Staff group and apply
provisions from the regulations. 

  

	 	•	 	 A series of specific policies are applicable to the Identified Staff, which, in terms of individual annual
variable remuneration, essentially represent the following: 

  

	 	•	 	 receiving this remuneration partly in shares and partly in cash (typically distributed as 50% shares / 50% cash);

  

	 	•	 	 a portion of the annual variable remuneration shall be deferred (in your specific case, 60% of your total award
will be deferred (and as noted above, will be delivered 50% in shares and 50% in cash) and vests pro-rata over five-years, and is further subject to a performance overlay); 

 

	 	•	 	 any shares delivered are subject to a mandatory one-year retention (hold)
period and non-transferability; 

  

	 	•	 	 the accrual of the variable remuneration shall be conditional on certain circumstances not occurring (i.e., Malus
clauses – see below); 

  

	 	•	 	 the variable remuneration cannot exceed a certain percentage of the fixed remuneration (typically variable
remuneration cannot exceed twice your annual total fixed remuneration); and 

  

	 	•	 	 See terms and conditions of the applicable bonus plan (or the applicable Equity Plan Agreement in the case of
SCUSA shares) for full details. 

 With regard to the number of SAN ADRs that you may be awarded, whether immediate or
deferred, they will be calculated taking into account: (i) the amount resulting from applying corresponding applicable taxes and withholdings; and (ii) the weighted average per daily volume of the average weighted price of the Banco
Santander shares over the fifteen trading days immediately prior to the date on which Banco Santander’s board of directors will approve the applicable performance year bonuses for executive directors. 

With regard to the number of SCUSA shares that you may be awarded, whether immediate or deferred, they will be calculated in accordance with
the applicable SCUSA Equity Plan Agreement. 
  

	 	◾	 Without prejudice to certain situations such as disability and others that will be compiled in the deferral
plan regulations, the accrual of deferred remuneration, both in shares and cash, is not only contingent upon your continued employment at Santander through each payment date, but upon the fact that none of the following circumstances transpire in
the period prior to each of the deliveries, by opinion of the Group Board, at the request of the Group Appointments & Remuneration Committee, as a consequence of actions performed in previous years (malus clauses): 

 

	 	1.	 Deficient financial performance of the Banco Santander Group; 

 

	 	2.	 Breach by you of internal rules or regulations, including in particular those relating to risks;

  

	 	3.	 Material restatement of the Group’s financial statements when so considered by the external auditors,
except when appropriate pursuant to a change in accounting standards; or 

  

	 	4.	 Significant adverse changes in financial capital or in the Group’s risk profile. 

  
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 Notwithstanding the foregoing, once accrued, the payment of such deferred remuneration shall
not be subject to discretion of the Group Board, Group Appointments & Remuneration Committee, or any other entity. The operation of any clawback or disgorgement provision of any applicable compensation program agreement shall not be
considered the exercise of discretion for the purpose of this agreement. 
  

	 	•	 	 Please also note that you may not directly or indirectly engage in the hedging of shares either before or
following (for a period of one year) their delivery. 

 Benefits and 401(k) Savings Plan: 

 

	 	•	 	 You will continue to be eligible for 5 weeks of paid time off (PTO) annually. 

 

	 	•	 	 In addition to your bi-weekly salary, you will continue to be eligible to
participate in our Comprehensive Benefits Program, which includes a Flexible Benefits Plan (options such as medical, dental, vision, life, etc.). 

  

	 	•	 	 You will continue to be eligible to participate in the Santander 401(k) Plan, make
pre-tax 401(k) contributions and receive matching contributions. 

  

	 	•	 	 Santander reserves the right to change, end, or alter plans and eligibility dates at any time.

 End of Term: 
 Subject to the needs
of the business and the final determination of Santander Group, it is the SHUSA Board’s intention that at the completion of the two-year term contemplated herein (or sooner if circumstances have changes
and an appropriate successor SCUSA CEO is appointed), you will remain U.S. Country Head and SHUSA CEO and, in addition, return to your prior role as SBNA CEO. 

Termination without Cause or voluntary termination for Good Reason: 

In the event that your employment with SHUSA and/or SCUSA is terminated by the Company without Cause or you voluntarily terminate your employment with SHUSA
and/or SCUSA for Good Reason, you shall be entitled to receive (i) a lump sum payment equal to twelve months of base salary; (ii) a pro-rata bonus for time worked during the year in which your
termination occurs subject to treatment as variable compensation under CRD-IV as described herein; and (iii) provided that you are willing to provide continued services on a consulting basis as necessary
in order to assist future management with a smooth transition of your responsibilities, continued vesting (and payment) of all unvested Deferred Variable Compensation (including any deferred portion of the pro rata bonus described in item
(ii) of this paragraph) on the same schedule as if you had remained employed by SHUSA and SCUSA for the remainder of the deferral period.     

“Cause” and “Good Reason” Defined: 
  

	 	•	 	 For purposes of this letter, “Cause” will exist if one or more of the following has occurred:
(i) you commit an act constituting a felony under the laws of the United States or any state or political subdivision thereof; (ii) you materially violate laws, rules or regulations applicable to banks, investment banks, broker-dealers,
investment advisors or the banking, commodities, futures or securities industries generally; (iii) you commit an act constituting a breach of fiduciary duty, gross negligence or willful misconduct; (iv) you engage in conduct that violates
Santander’s internal policies or procedures and which is materially detrimental to the business, reputation, character or standing of Santander or any of its related entities; (v) you commit an act of fraud, dishonesty or

  
 4 

 

 
  

	 	 
misrepresentation that is materially detrimental to the business, reputation, character or standing of Santander or any of its related entities; (vi) you engage in a material conflict of
interest or material self-dealing; or (vii) after notice by Santander and a reasonable opportunity to cure, you materially breach your obligations and/or representations as set forth in this letter and/or employment-related agreements or you
fail to perform your duties as an employee of Santander. 

  

	 	•	 	 For purposes of this letter, “Good Reason” shall mean the occurrence of any of the following events
(i) any material diminution in your responsibilities or authorities, (ii) the assignment to you of duties that are materially inconsistent with, or materially impair, your ability to perform the duties then assigned to you, or any change
in the reporting structure so that you no longer report to the board of directors of SHUSA or SCUSA, (iii) any relocation of the principal place where you are required to perform your duties to a city that is more than 30 miles from either
Boston or Dallas; (iv) a material breach by SHUSA or SCUSA or any of their respective affiliates of any material obligation to you; and (v) failure by SHUSA and the Group to come to an agreement with you to return you to your role as the
CEO of SBNA while you remain in your role as the SHUSA CEO and the U.S. Country Head. 

  

	 	•	 	 You agree to allow Santander to withhold any such reimbursement amounts owed to Santander pursuant to this
Agreement from other monies due to you upon termination, including but not limited to final pay owed to you in connection with your employment, and you agree to sign at the time of resignation and/or termination any authorizations required to permit
Santander to make such withholding from final pay. 

 Notice Provision: 

Given the strategic importance of your position(s), you hereby acknowledge and agree that Santander, its client relationships and/or its business opportunities
would likely suffer irreparable harm were you to resign or otherwise end your employment without providing sufficient notice to Santander. To avoid such harm, and in exchange for the pay and benefits Santander extends to you pursuant to this
letter, you agree to provide Santander with ninety (90) days prior written notice of your intent to end your employment with Santander (the “Notice Period”). During the Notice Period you will be paid your base salary pursuant to
Santander’s regular payroll practices and will be eligible to continue to participate in the employee benefit plans in which you were enrolled prior to submitting your resignation, with the exception that you will not continue to accrue paid
time off during the Notice Period. You will be expected to perform all duties and tasks assigned to you during the Notice Period, including all assignments related to the transition of your duties and responsibilities, and you will devote all of
your working time, labor, skill and energies to the business and affairs of Santander.
 You agree that during the Notice Period you will continue to owe
Santander the same duties, if any that you owed to Santander during your employment, and you will continue to abide by all prior non-disclosure and non-solicitation
agreements you have entered into with Santander. You agree by signing below not to compete with Santander, or to start employment with or an engagement with a competitor, during the period of time you are employed by Santander, including during
the Notice Period. You agree that during your employment, including the Notice Period, and regardless of whether your title, position or responsibilities change at any point, you will not directly or indirectly become employed or engaged by
(whether as an employee, consultant, proprietor, partner, director or otherwise) another bank, financial institution, or any other competitor of Santander.

Upon receipt of your resignation, Santander may, in its sole discretion, waive the Notice Period, in which case your employment will be terminated upon
receipt of written notice from Santander, which Santander can invoke at any time during the Notice Period. Under such circumstances, Santander will not be obliged to provide you with pay in lieu of notice and, in turn, you will no longer be bound by
the specific non-competition restriction outlined in the prior paragraph.

  
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 You agree that because your services are personal and unique and because you will have access to and will be
acquainted with Santander’s confidential information and/or its customer relationships, to the fullest extent permitted by law, this Notice Provision will be enforceable by injunction, specific performance or other equitable relief, without
bond and without prejudice to any other rights or remedies that Santander may have for breach of this Notice Provision.
 Compliance with Laws: 

All payments referenced herein are contingent on compliance with, and subject to, all applicable laws and regulations; and arrangement intended to comply with
Internal Revenue Code Section 409A and to be interpreted accordingly (with each payment described above to be treated as a separate payment under 409A). 

It is a condition of this letter that you will sign: 
  

	 	1.	 Non-Compete Agreement: that contains additional requirements for
the protection of Santander’s business (a copy of which is enclosed); 

  

	 	2.	 Non-Disclosure Agreement: that contains additional requirements
for the protection of Santander’s business (a copy of which is enclosed); and 

  

	 	3.	 Non-Solicitation Agreement: that contains additional
requirements for the protection of Santander’s business (a copy of which is enclosed). 

 Representations: 

You represent, by signing below, that you are not relying on any promises that are not set out in this letter.

Notwithstanding anything herein to the contrary, any payments or benefits contemplated by this letter are subject to and conditioned on their compliance with
applicable laws and regulations, including without limitation the FDIC’s regulations governing “golden parachute payments”. 
 Employment at
Santander is considered to be “at-will”, meaning it is at the mutual consent of both Santander and you and may be terminated by either you or Santander at any time, with or without cause and with or
without notice other than the notice required to be given by you as described above.
 Scott, I look forward to seeing the progress I know you will make
towards our many U.S. priorities over the coming years. 
 Sincerely,

/s/ T. Timothy Ryan 
 T. Timothy Ryan 

Chairman of Santander Holdings USA, Inc. 
  

					
	Acknowledged and Agreed:	 		 	
			
	/s/ Scott Powell	 		 	9/14/18
	Scott Powell	 		 	Date

  
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 RESTRICTIVE COVENANTS 

Employee acknowledges that the opportunity to be employed by SHUSA confers a substantial benefit upon him/her and, in consideration of employee’s ability
to receive compensation from SHUSA and his/her receipt of confidential information, employee (1) re-acknowledges the terms of any Confidentiality and Restrictive Covenant Agreement(s) (or similar
agreement(s)), and (2) agrees to the following non-competition and non-disparagement covenants (the terms and covenants in (1) and (2) together, the
“Restrictive Covenants”). 
 Non-Compete: 

Employee will not, during the Non-Compete Period, without the prior written consent of SHUSA, engage in any activity in
which employee contributes his/her knowledge directly or indirectly, in whole or in part, on his/her behalf or on behalf of or in conjunction with others, as a contractor, agent, shareholder, owner, partner, director, officer, principal, member,
employee, or in any other capacity or manner whatsoever, for his/her own benefit or for the benefit of any other person or entity, to an entity currently engaged in, or desiring to become engaged in, any Competing Activity in the United States.
Notwithstanding the foregoing, nothing in this paragraph restricts employee from owning less than 1% of any class of securities of such entity as a passive investor, if such securities are listed on a national securities exchange. Employee
understands that this provision does not restrict him/her from accepting any employment with an entity that does not engage in any Competing Activities. 

Non-Disparagement: 

Employee, on the one hand, and the SHUSA Board and the senior executives of SHUSA, on the other hand, will not make any disparaging or defamatory or untrue
remarks to any third party concerning the other. 
 “Non-Compete Period” means during your service
with SHUSA and/or SCUSA and for a period of 12 months thereafter. 
 “Competing Activity” means any business activity that involves or is
related to banking or to providing vehicle finance. 
 Employee acknowledges that the Restrictive Covenants are designed to, among other things, protect the
interests of SHUSA and SCUSA in confidential and proprietary information, trade secrets, customer and employee relationships, orderly transition of responsibilities, and other legitimate business interests. All Restrictive Covenants are hereby
incorporated by reference as if fully set forth herein. 
  

					
	Acknowledged:	 		 	
			
	/s/ Scott Powell	 		 	9/14/18
	Scott Powell	 		 	Date

  
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 Non-Disclosure of Confidential Information 

I acknowledge that the trade secrets of Santander as they may exist from time to time and other confidential information concerning Santander’s business,
products, technical information, sales activities, procedures, promotion, pricing techniques, business plans, customer and dealer lists and credit and financial data concerning customers are valuable, special and unique assets of Santander, access
to and knowledge of which are essential to the performance of my duties while employed by Santander. In light of the highly competitive nature of the industry in which the business of Santander is conducted, I further agree that all knowledge and
information described in the preceding sentence not in the public domain and heretofore obtained by me as a result of employment by Santander shall be considered confidential information. In recognition of this fact, I agree that I will not disclose
any of such confidential information to any person or other entity for any reason or purpose whatsoever, except as may become necessary in the performance of any duties or tasks I might hereafter be assigned as an employee of Santander or any of
Santander or Santander affiliated companies, nor shall I make use of any such confidential information (i) for my own purposes (ii) for any purposes not related to my employment; or (iii) for the benefit of any person or other entity
(except Santander and its affiliates, if any) under any circumstances. 
 Notwithstanding the foregoing provisions, I understand, acknowledge and agree, as
does Santander, that Santander’s trade secrets and confidential information shall not be deemed to include (1) information that was in my possession prior to my employment by Santander or any of its affiliates, and is not known by me to be
subject to another confidentiality agreement with or other obligation of secrecy to Santander or any of its affiliates, (2) information that becomes generally available to and known by the public other than as a result of disclosure by me, or
(3) information that becomes generally available to me on a non-confidential basis from a source other than Santander or any of its affiliates, provided such source is not known by me to be bound by a
confidentiality agreement with or other obligation of secrecy to Santander or any of its affiliates. In addition, nothing contained herein shall be deemed to preclude me from responding to requests for information or inquiries from the Office of the
Comptroller of the Currency or the Federal Deposit Insurance Corporation, or any other federal banking regulator. 
 Nothing in this Agreement prohibits or
limits me from initiating communications directly with, responding to any inquiry from, volunteering information to, or providing testimony before, the Securities and Exchange Commission, the Department of Justice, FINRA, any other self-regulatory
organization or any other governmental, law enforcement, or regulatory authority, or any reporting of, investigation into, or proceeding regarding suspected violations of law, and that I am not required to advise or seek permission from Santander
before engaging in any such activity. In connection with any such activity, I must inform such authority that the information being provided is confidential. Despite the foregoing, I am not permitted to reveal to any third-party, including any
governmental, law enforcement, or regulatory authority, information that I came to learn during the course of employment with Santander that is protected from disclosure by any applicable law or privilege, including but not limited to the
attorney-client privilege, attorney work product doctrine and/or other applicable legal privileges. Santander does not waive any applicable privileges or the right to continue to protect its privileged attorney-client information, attorney work
product, and other privileged information. Additionally, I recognize that my ability to disclose information may be limited or prohibited by applicable law and Santander does not consent to disclosures that would violate applicable law. Such
applicable laws include, without limitation, laws and regulations restricting disclosure of confidential supervisory information1 or disclosures subject to the Bank Secrecy Act (31 U.S.C. §§ 5311-5330), including information that would reveal the existence or contemplated filing of a suspicious activity report. 

 

	1 	 Confidential supervisory information includes any information or materials relating to the examination and
supervision of Santander by applicable bank regulatory agencies, Santander materials responding to or referencing non-public information relating to examinations or supervision by bank regulatory agencies and
correspondence to or from applicable banking regulators. 

  
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 No employee shall be held criminally or civilly liable under any Federal or State trade secret law for the
disclosure of a trade secret that is made in confidence to a Federal, State, or local government official or to an attorney solely for the purpose of reporting or investigating a suspected violation of law. No employee shall be held criminally or
civilly liable under any Federal or State trade secret law for the disclosure of a trade secret that is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal. If an employee files a lawsuit
against Santander for retaliation for reporting a suspected violation of law, the employee may disclose the trade secret to his/her attorney and use the trade secret information in the court proceeding, if the employee files any document containing
the trade secret under seal; and does not disclose the trade secret, except pursuant to court order. 
  

					
	Acknowledged:	 		 	
			
	/s/ Scott Powell	 		 	9/14/18
	Scott Powell	 		 	Date

  
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 Non-Solicitation Agreement 

In consideration of your employment with Santander, you agree that beginning on the date you execute this
Non-Solicitation Agreement (“Agreement”) and: 
 1)    continuing
through twelve (12) months after the last date of your employment, you will not, directly or indirectly, solicit , induce, or cause others to solicit or induce, any client or potential client of Santander in connection with any business
(whether as an employee, consultant, director, member, partner or shareholder) that is in direct or indirect competition with any active or planned business of Santander about which you have knowledge as a result of your employment with the bank
(“Competitive Business”) where (a) you serviced or had contact with such clients(s) or potential client(s) during your employment with Santander and/or (b) about whom you obtained Confidential Information (as that term is defined
in the Non-Disclosure of Confidential Information Agreement you executed as a condition of employment with Santander) while employed by Santander; 

2)    continuing through twelve (12) months after the last date of your employment, you will not, directly or
indirectly, solicit or induce, or cause others to solicit or induce, any person who is employed by Santander (or its related entities) or any person who was employed or engaged by Santander or its related entities within the last 6 months of your
employment to terminate his or her employment or engagement with Santander (or its related entities) or to accept employment with anyone or any entity other than Santander (or its related entities). 

This Agreement and its restrictive covenants will apply in full force and effect as follows: section (1) will only apply in the event that you resign or
are terminated with “cause” and section (2) will apply in the event that you resign or are terminated with or without “cause.” 

For purposes of this Agreement, “cause” shall mean (i) you commit an act constituting a felony under the laws of the United States or any state
or political subdivision thereof; (ii) you materially violate laws, rules or regulations applicable to banks, investment banks, broker-dealers, investment advisors or the banking, commodities, futures or securities industries generally;
(iii) you commit an act constituting a breach of fiduciary duty, gross negligence or willful misconduct; (iv) you engage in conduct that violates Santander’s internal policies or procedures and which is materially detrimental to the
business, reputation, character or standing of Santander or any of its related entities; (v) you commit an act of fraud, dishonesty or misrepresentation that is materially detrimental to the business, reputation, character or standing of
Santander or any of its related entities; (vi) you engage in a material conflict of interest or material self-dealing; or (vii) after notice by Santander and a reasonable opportunity to cure, you materially breach your obligations and/or
representations as set forth in this letter and/or employment-related agreements or you fail to perform your duties as an employee of Santander. 
 You
acknowledge that this Agreement does not constitute a contract of employment and does not imply that Santander will continue your employment for any period of time. You acknowledge and agree that as provided in this letter, your employment with
Santander is at-will, and that either party may terminate the relationship at any time and for any reason. The obligations contained in this Agreement shall not be affected by any change in your position,
title, function or duties with Santander during the course of your employment. 
 You acknowledge and agree that the covenants and restrictions in this
Agreement are necessary to protect the legitimate business interests of Santander, including, without limitation, customer information and goodwill, and consider the restrictions to be reasonable for such purpose. You acknowledge that any breach by
you of the obligations set forth in this Agreement would substantially and materially impair and irreparably harm Santander’s business and good will; that such impairment and harm would be difficult to measure; and, therefore, total
compensation in solely monetary terms would be inadequate. Consequently, you agree 

  
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that, in the event of a breach or threatened breach of this Agreement, in addition to monetary damages or such other remedies which may be available, Santander shall be entitled to specific
performance and other equitable relief, including temporary or permanent restraining orders and/or other injunctive relief without the necessity of proving actual damages and/or posting a bond, as well as any equitable accounting of all earnings,
profits or other benefits arising from any violation hereof, and to the payment by you, if the Bank succeeds in obtaining a temporary or permanent restraining order, of all costs and expenses incurred by Santander in enforcing the provisions hereof
against you, including attorneys’ fees incurred by Santander. The existence of any claims or cause of action by you against Santander, whether predicated on this Agreement or otherwise, shall not constitute a defense to the enforcement by
Santander of such obligations. 
 This Agreement, including but not limited to Santander’s right to injunctive relief, shall survive the termination of
your employment and shall remain in full force and effect for the period provided. 
  

					
	Acknowledged:	 		 	
			
	/s/ Scott Powell	 		 	9/14/18
	Scott Powell	 		 	Date

  
 11

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