Document:

EX-10.25

 Exhibit 10.25 

 

Certain information contained in this document, identified by [***], has been redacted because it is both (i) not
material and (ii) would likely cause competitive harm to the Registrant if publicly disclosed. 

 Confidential 

Quality Agreement of DSM Biomedical and Cardiva Medical, Inc 

Version No.: 01; Issue Date: 07/18/2018 
  

 
 This Quality Agreement is established between: 

the Quality Agreement — Giver: 

DSM Biomedical, Inc. d.b.a. DSM Biomedical, a corporation organized and existing under the laws of Delaware/USA, having its
principal office at 735 Pennsylvania Ave., Exton, PA 19341 USA.  
 Hereafter referred to as “DSM Biomedical”

 and 
 the Quality Agreement —
Acceptor: 
 Cardiva Medical, Inc, a corporation organized and existing under the laws of Delaware/USA, having its
principal office at 2900 Lakeside Drive #160, Santa Clara, CA 95054 USA.  
 Hereafter referred to as
“Cardiva” 
 This agreement relates to: 

Manufacturing location(s): 735 Pennsylvania Drive, Exton, PA 19341 USA 

Product: See Appendix I. Hereafter referred to as “PRODUCT” 

  
 Page 1 of 8 

 Confidential 

Quality Agreement of DSM Biomedical and Cardiva Medical, Inc 

Version No.: 01; Issue Date: 07/18/2018 
  

 Table of Contents 

APPENDICES1 
  

					
	1.	 	Definitions	  	3
			
	2.	 	Purpose & Scope	  	3
			
	3.	 	Escalation of Product Incidents*	  	3
			
	4.	 	Dispute Resolution	  	3
			
	5.	 	Agreement Maintenance	  	3
			
	6.	 	Responsibilities	  	4
			
	7.	 	Revision History	  	7
			
	8.	 	Quality Agreement Approval	  	8

 APPENDICES1 

 

			
	Appendix I	  	List of Product(s) & Receiving Sites
		
	Appendix II	  	Main Contacts
		
	Appendix III	  	Example Certificate of Conformance

  
  

	1	 Appendices have their respective revision and approval control. Each appendix may be updated individually and
independently upon mutual agreement by both parties without impacting the prior terms and conditions of this quality agreement and the other appendices. 

It is the responsibility of all involved parties to follow the current version of the main document of the quality agreement and the current version of the
appendices. 

  
 Page 2 of 8 

 Confidential 

Quality Agreement of DSM Biomedical and Cardiva Medical, Inc 

Version No.: 01; Issue Date: 07/18/2018 
  

	1.	 DEFINITIONS 

  

			
	GMP:	  	Good Manufacturing Practice means the part of quality assurance which ensures that products are consistently produced and controlled in accordance with the quality standards appropriate to their intended use.
		
	Qualification:	  	Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and lead to the expected results. Qualification is part of validation, but the individual qualification steps alone do not
constitute process validation.
		
	Quality Agreement:	  	This written, formalized, binding agreement between DSM Biomedical and Cardiva detailing the agreed-upon quality requirements and responsibilities for the Products and/or services, and for the quality systems and structures
used to ensure quality and regulatory compliance.
		
	Quality Control (QC):	  	The part of GMP designed to evaluate the manufacturing output of uniform batches to confirm that they conform to established specifications.
		
	Recall/Withdrawal:	  	Tracing and recovery as far as possible, to a desired distribution level (distribution centers, clinical sites, marketplace) of a particular batch or of a series of batches of product or investigational product which has left the
control of the manufacturing, marketing or research company and has been found to be in violation of a company or regulatory standard or, where safety, efficacy, purity, or quality of the product or investigational product is questionable. In some
markets, the term “withdrawal” many be used for legal classification purposes. A recall is the removal of a marketed product which a Regulatory/Health Authority considers to be in violation of the laws it administers.
		
	Supply Agreement:	  	The formal written document, which details the business and logistics requirements of DSM Biomedical’s supply of Products to Cardiva.

  

	2.	 PURPOSE & SCOPE 

This Quality Agreement defines the conditions to be fulfilled by the Supplier, DSM Biomedical, to ensure compliance with the applicable regulatory
requirements. A Supplier is defined as a Manufacturer of raw materials, components, or finished product, or a Distributor or Contractor who performs further processing, packaging, or testing of raw materials, components, or finished product. This
agreement has to be signed by the Authorized person of the Supplier and formally authorized to represent and commit the Supplier’s company. All conditions listed below are to be considered as critical success parameters if we are to enter into
a mutually beneficial agreement with a Customer. These conditions and requirements are relevant and pertinent only to those activities related to the Products delivered by the Supplier to applicable Cardiva companies. 

Any Change with impact on the contents of this document shall be promptly communicated to Cardiva prior to its implementation. 

This Quality Agreement is not intended to represent or enable a purchase contract or to describe financial terms, which are exclusively covered by the Supply
Agreement. In case of any inconsistency between the terms and provisions of this Quality Agreement with the terms and provisions of the Supply Agreement, the terms and provisions of the Supply Agreement shall prevail, except with regard to the
allocation of medical device responsibilities, for which this Quality Agreement shall be prevailing. This Quality Agreement does not represent or replace the Supply Agreement or any other agreement and/or amendment(s) thereto among Cardiva
and DSM Biomedical. 
 This Quality Agreement shall become effective as of the date of the last approval signature and shall expire upon the
expiration of the Supply Agreement. DSM Biomedical confirms that if materials used during the manufacturing are from animal origin, then it will always comply with the applicable international legal requirements for animal derived material
use in medical devices and provide required documentation as applicable. 
  

	3.	 ESCALATION OF PRODUCT INCIDENTS 

DSM Biomedical is responsible to escalate any PRODUCT incidents, if necessary. DSM Biomedical shall support Cardiva in their escalation
process and shall therefore maintain internal procedures and data collection to ensure proper evaluation, assessment of criticality, and timely notification of product issues requested by Cardiva. The data collection shall cover at minimum
information obtained from product complaints, laboratory test results (release), deviations, batch rejections, validations, and proof of execution, as related to product manufactured for Cardiva. Requested information shall be forwarded to
Cardiva in a timely manner to ensure patient safety, limit product supply interruption, as well as to enable compliance to Regulatory requirements. 
  

	4.	 DISPUTE RESOLUTION 

For any disputes arising in quality related matters, the ultimate decision will reside with the senior management of the quality departments of both parties
who shall in good faith promptly attempt to resolve the dispute. If the parties cannot reach agreement, the matter shall be resolved in accordance with the dispute resolution provisions of the Supply Agreement. 

 

	5.	 AGREEMENT MAINTENANCE 

This Quality Agreement shall come into force upon the signature of the contractual parties. 

  
 Page 3 of 8 

 Confidential 

Quality Agreement of DSM Biomedical and Cardiva Medical, Inc 

Version No.: 01; Issue Date: 07/18/2018 
  

 Amendments and additions to this Quality Agreement and its appendices shall only be carried out on mutual
consent and shall only be valid upon approval by the parties. 
 This Quality Agreement can be reviewed and updated upon request by either party. Otherwise
review of this agreement will be part of the Cardiva GMP audit preparation and execution. 
  

	6.	 RESPONSIBILITIES 

 

									
	 No.
	  	 Responsibilities
	  	 Cardiva
	  	 DSM

Biomedical
	  	 N/A

	1	  	Compliance	  		  		  	
					
	1.1	  	DSM Biomedical shall manufacture PRODUCT under this Agreement in compliance with the U.S. Quality System Regulation (QSR); ISO 13485; [***]; [***]; [***], to the extent that they apply to the components of the PRODUCT; as
well as in accordance with DSM Biomedical’s protocols (together the “Regulations”).	  		  	X	  	
					
	1.2	  	Cardiva PRODUCTs fulfil the requirements of [***] to control the source(s) of raw materials, finished products, production processes, and sub-contractors as it relates to materials of
animal origin. Details of how compliance is achieved is evaluated and determined annually through supplier management.	  	X	  	X	  	
					
	1.3	  	Obtain and maintain all applicable registrations and licenses per legal and regulatory requirements	  	X	  		  	
					
	1.4	  	Upon request, agree to provide reasonable assistance to Cardiva in obtaining any such registrations; including providing information to regulatory agency requesting the information to the extent such information is readily
available or can be developed at minimal cost to DSM Biomedical; alternatively, Cardiva agrees to [***], provided DSM Biomedical gives reasonable advance notice to Cardiva of the tasks DSM Biomedical intends to
undertake. Confidential disclosures will be made by DSM Biomedical directly to the third-party agency, on behalf of Cardiva; Cardiva’s direct access to data will remain limited to
non-confidential or non-proprietary reports customarily provided by DSM Biomedical.	  		  	X	  	
					
	1.5	  	Conform to an established, documented, and maintain a quality system to ensure qualified facilities/equipment/personnel/processes/methods/materials are employed in the manufacture/quality control/storage and distribution of the
product, as applicable, for compliance to the relevant GMP and to ensure no adverse impact to the product quality.	  		  	X	  	
					
	1.6	  	Mutually agree upon specifications for the PRODUCTs which are the subject of this agreement.	  	X	  	X	  	
					
	1.7	  	Changes to the agreed upon specifications must be mutually agreed upon and communicated in writing between the parties to this agreement, except for regulatory requirement changes or changes that do not impact product
quality, which can be implemented without mutual agreement. Regulatory requirement changes must be implemented by the regulatory requirement implementation date.	  	X	  	X	  	
					
	1.8	  	Manufacture PRODUCTs that conform to the mutually agreed upon specifications.	  		  	X	  	
					
	1.9	  	Shall have a quality agreement with third parties used for production, packaging. testing or processing the PRODUCTs in any manner, which could be reviewed during an audit.	  		  	X	  	
					
	2	  	Manufacturing, Packaging, and Labeling	  		  		  	
					
	2.1	  	Document that manufacturing and packaging process are fit for purpose. Demonstrate the commissioning of critical systems and equipment used in the manufacture and control of the PRODUCTs.	  		  	X	  	
					
	2.2	  	Agree upon special labelling requirements.	  	X	  	X	  	
					
	2.3	  	Material shall be labeled with identity, batch number/manufacturing date at any time during warehousing, production, QC testing, storage and transferring.	  		  	X	  	

  
 Page 4 of 8 

 Confidential 

Quality Agreement of DSM Biomedical and Cardiva Medical, Inc 

Version No.: 01; Issue Date: 07/18/2018 
  

									
	 No.
	  	 Responsibilities
	  	 Cardiva
	  	 DSM

Biomedical
	  	 N/A

	2.4	  	Product identity, batch number/manufacturing date shall be specified on the product label.	  		  	X	  	
					
	3	  	Quality Control	  		  		  	
					
	3.1	  	Supplied PRODUCT shall meet specifications and shall be subject to quality control inspection by DSM Biomedical in accordance with DSM Biomedical’s quality control standards and systems.	  		  	X	  	
					
	3.2	  	Raw material and/or components shall be supplied from an approved qualified source.	  		  	X	  	
					
	3.3	  	Perform incoming control of the raw materials, primary packaging components, in-process and final QC release testing, and monitoring of the product in accordance with the manufacturing and QC
instruction, specifications, or instructions, and GMP.	  		  	X	  	
					
	3.4	  	Sampling plan for the quality control testing shall be statistical.	  		  	X	  	
					
	4	  	Documentation and Records	  		  		  	
					
	4.1	  	Certificate of Conformance listing the manufacturing address shall be supplied with each batch.	  		  	X	  	
					
	4.2	  	Certificate of Conformance will be prepared according to the agreed upon specifications or an agreed upon alternative that is defined in this agreement (an example COC is attached in Appendix III).	  		  	X	  	
					
	4.3	  	Agree upon special Certificate of Conformance requirements.	  	X	  	X	  	
					
	4.4	  	Records required by the agreed upon quality system will be maintained for a period of [***] years from approval.	  		  	X	  	
					
	5	  	Storage and Distribution	  		  		  	
					
	5.1	  	Ensure that PRODUCTs are stored and shipped in accordance with Cardiva’s recommended storage conditions.	  		  	X	  	
					
	6	  	Batch Release	  		  		  	
					
	6.1	  	PRODUCT shall only be released for shipment to Cardiva after the batch records and QC test results have been reviewed and reported, and all deviations investigated by a qualified person or designee, ensuring the PRODUCT
complies with agreed upon specifications.	  		  	X	  	
					
	6.2	  	No product with a deviation or compliance failure which in DSM Biomedical’s reasonable estimation may impact the safety or effectiveness of the PRODUCT shall be released to Cardiva without prior notification and
authorization by Cardiva.	  	,	  	X	  	
					
	7	  	Change Control	  		  		  	
					
	7.1	  	Changes will be evaluated and communicated based upon agreed criteria and timelines.	  	X	  	X	  	
					
	7.2	  	 DSM Biomedical shall not implement any changes to any process, system, or activity that in DSM Biomedical’s reasonable
estimation may impact the safety or efficacy of the PRODUCT or requires a regulatory submission without prior written approval from a Cardiva Quality representative. Changes that shall be communicated and approved by Cardiva
prior to the implementation include:
  

•  Change to the production, composition, characteristics, specifications, or products used during
the manufacturing process which are from animal origin, that may impact the safety or effectiveness of the PRODUCT,
  

•  change of production site,

 
 •  change to the process ([***]
which could reasonably impact the product characteristics, quality, [***] status).
	  		  	X	  	
					
	8	  	Nonconformance	  		  		  	
					
	8.1	  	All non-conformances should be investigated. Where applicable this includes the identification of the root cause, a risk analysis (including the risk to other lots and the impact to other test
results) of the actions taken for correction of the problem, prevention of future occurrence and the formal conclusion by Quality Assurance. If an investigation reveals that there is an impact to PRODUCTs received by Cardiva, DSM	  		  	X	  	
					
	9	  	Out-of-Specification (OOS)	  		  		  	
					
	9.1	  	Out-of-specification (OOS) test results should be investigated and documented according to a documented procedure.	  		  	X	  	
					
	10	  	Deviations	  		  		  	
					
	10.1	  	If deviations from an established process are recorded, there should be evidence of suitable investigations and a review of the quality of the PRODUCTs.	  		  	X	  	
					
	10.2	  	Confirmed OOS results on any deviation or unusual situation that is likely to adversely affect timely delivery or continued distribution of PRODUCTs or that is likely to adversely affect batches of PRODUCTs already supplied to
Cardiva should be immediately reported to Cardiva [***].	  		  	X	  	

  
 Page 5 of 8 

 Confidential 

Quality Agreement of DSM Biomedical and Cardiva Medical, Inc 

Version No.: 01; Issue Date: 07/18/2018 
  

									
					
	11	  	Complaints	  		  		  	
					
	 11.1
	  	Have a written procedure to investigate and document quality related complaints. A root cause analysis, actions taken for correction of the problem, prevention of future occurrence and the formal conclusion will be provided to
Cardiva within a reasonable time after receipt of the complaint.	  	X	  	X	  	

  
 Page 6 of 8 

 Confidential 

Quality Agreement of DSM Biomedical and Cardiva Medical, Inc 

Version No.: 01; Issue Date: 07/18/2018 
  

									
	 No.
	  	 Responsibilities
	  	 Cardiva
	  	 DSM

Biomedical
	  	 N/A

	11.2	  	Complaints made shall at least indicate DSM Biomedical’s batch number of the component and complaint subject. The complaint shall be communicated to DSM Biomedical within [***] days of identification. Samples will
be provided where appropriate and available.	  	X	  		  	
					
	11.3	  	The parties shall cooperate in the exchange of information required to effectively conduct an investigation.	  	X	  	X	  	
					
	12	  	Recall	  		  		  	
					
	12.1	  	In the case of a recall of the PRODUCTS, DSM Biomedical shall inform Cardiva without unreasonable delay of the planned recall.	  		  	X	  	
					
	12.2	  	Have a written recall procedure.	  	X	  	X	  	
					
	12.3	  	Cardiva shall notify DSM Biomedical of any finished product recall which has been investigated or is under investigation and has potential to be related to the quality of the PRODUCTS, as soon as possible.	  	X	  		  	
					
	12.4	  	The parties shall cooperate in the exchange of information required to effectively conduct a recall or recall investigation.	  	X	  	X	  	
					
	13	  	Auditing	  		  		  	
					
	13.1	  	Audits shall seek to verify that DSM Biomedical has performed and continues to perform quality related activities in compliance with the Quality Agreement and applicable regulatory requirements. Cardiva’s right to
perform or have performed audits does not in any way limit the obligation of DSM Biomedical to perform its activities in compliance with the Quality Agreement and applicable regulatory requirements.	  		  	X	  	
					
	13.2	  	If required, a confidentiality agreement will be executed within a reasonable period of time prior to the audit.	  	X	  	X	  	
					
	113	  	Cardiva shall provide the notification to DSM Biomedical at least [***] days prior to scheduling an audit of the facilities.	  	X	  		  	
					
	13.4	  	Agree that periodic audits are performed at DSM Biomedical’s site no more than [***] for a maximum of [***] and up to [***]. In the event of a “For Cause” audit, the number of audit days and personnel will be
mutually agreed upon prior to the audit. Agree that Cardiva may conduct periodic audits or accept third-party certifications in lieu of on-site audit. Cardiva shall send DSM Biomedical a
formal audit report within no more than [***] days after the audit.	  	X	  		  	
					
	13.5	  	DSM Biomedical shall issue responses within [***] days to all observations in writing to Cardiva. Where DSM Biomedical commits to a corrective action, a description and timeframe for completion will be included
in the written response.	  		  	X	  	
					
	13.6	  	Any Cardiva Notified Body or Competent Authority may perform unannounced inspections or audits of DSM Biomedical at its facility. To the extent that DSM Biomedical reasonably believes that providing Cardiva
with access to such sites would compromise Cardiva’s obligations of confidentiality to third parties or require the disclosure of any confidential information or trade secrets, DSM Biomedical shall grant such access to an
independent third party designated by Cardiva in its reasonable discretion, and reasonably acceptable to DSM Biomedical, to conduct such audit. DSM Biomedical shall have the right to review any report furnished by such third
party and delete any information it deems a confidential trade secret or the disclosure of which would violate such confidentiality obligations, prior to the release of said report to Cardiva,	  	X	  	X	  	
					
	13.7	  	Audit Reports are the property of DSM Biomedical. If so requested by Regulatory Authorities or as required by applicable law, DSM Biomedical may disclose all or part of Audit Reports to Regulatory Authorities without
prior approval by Cat-diva. Furthermore, DSM Biomedical may, if so requested, disclose Audit Reports to licensees, distributors, or customers of DSM Biomedical
or its affiliates or any other Third Party to whom Cardiva or its affiliate supply PRODUCT or any products that incorporate PRODUCT, provided that DSM Biomedical or its affiliate has an agreement in place with such Third Party that
includes appropriate confidentiality obligations.	  		  	X	  	

  

	7.	 REVISION HISTORY 

 

					
	 Version
	  	 Date
	  	 Changes

	01	  	28-August-2018	  	Initial Release.

  
 Page 7 of 8 

 Confidential 

Quality Agreement of DSM Biomedical and Cardiva Medical, Inc 

Version No.: 01; Issue Date: 07/18/2018 
  

	8.	 QUALITY AGREEMENT APPROVAL 

On behalf of DSM Biomedical: 
  

			
	Signature:	 	 /s/ Dennis King

		 	Signer Name: Dennis King
		 	Signing Reason: I have reviewed this document
		 	Signing Time: 7/16/2019 11:46:47 AM PDT

 Date: 
 Dennis King

 Director, Quality Assurance 
  

							
	Signature:	  	 /s/ Tim Shannon
	  	            	  	 /s/ Inne Verhoeven

		  	Signer Name: Tim Shannon	  		  	Signer Name: Inne Verhoeven
		  	Signing Reason: I have reviewed this document	  		  	Signing Reason: I approve this document
		  	Signing Time: 10/23/2018 4:46:50 AM PDT	  		  	Signing Time: 10/29/2018 11.50.38 AM PDT
				
	Date:	  		  		  	
	Tim Shannon	  		  	Inne Verhoeven
	Business Director, Global	  		  	Senior Business Unit Controller
	VP & BM, Global Commercialization	  		  	
	
	On behalf of Cardiva:
				
	Signature:	  	 /s/ Jennifer Lee
	  		  	
	Date: 08/28/18	  		  	
	Jennifer Lee	  		  	
	Director of Quality Assurance and Engineering	  		  	
				
	Signature:	  	 /s/ Terry Passarotti
	  		  	
	Date: 08/28/18	  		  	
	Terry Passarotti	  		  	
	Director of Regulatory and Clinical Affairs	  		  	

  
 Page 8 of 8 

 Confidential 

Quality Agreement of DSM Biomedical and Cardiva Medical, Inc 

Version No.: 01; Issue Date: 07/18/2018 
  

 Appendix I: List of Product and Receiving Sites 

 

							
	 Product Name
	  	 DSM Biomedical

Product Part Number
	  	 Cardiva

Product Part Number
	  	 Receiving Site

	[***] Collagen Plug, [***]	  	[***]	  	[***]	  	To be determined per purchase order
	[***] Collagen Plug, [***]	  	[***]	  	[***]	  	To be determined per purchase order

 Appendix I Revision History 
  

							
	 Version
	  	 Date
	  	 Changes
	  	 
	01	  	18-JULY-2018	  	Initial Release.	  	

 APPENDIX I APPROVAL 
 On
behalf of DSM Biomedical:  
 Signature: 
 Date:

 Dennis King 
 Director, Quality Assurance

  

							
	Signature:	  	 /s/ Tim Shannon
	  		  	 /s/ Inne Verhoeven

		  	Signer Name: Tim Shannon	  		  	Signer Name: Inne Verhoeven
		  	Signing Reason: I have reviewed this document	  		  	Signing Reason: I approve this document
		  	Signing Time: 10/23/2018 4:46:50 AM PDT	  		  	Signing Time: 10/29/2018 11.50.38 AM PDT
		
	Date:	  	
	Tim Shannon	  		  	Inne Verhoeven
	Business Director, Global	  		  	Senior Business Unit Controller
	VP & BM, Global Commercialization	  		  	
	
	On behalf of Cardiva:
				
	Signature:	  	 /s/ Jennifer Lee
	  		  	
	Date: 08/28/18	  		  	
	Jennifer Lee	  		  	
	Director of Quality Assurance and Engineering	  		  	
				
	Signature:	  	 /s/ Michael Hendrix
	  		  	
	Date: 08/28/18	  		  	
	Michael Hendrix	  		  	
	Director, Operations & Supply Chain Management	  		  	

  
 Page 1 of 1 

 Confidential 

Quality Agreement of DSM Biomedical and Cardiva Medical, Inc 

Version No.: 01; Issue Date: 07/18/2018 
  

 Appendix II: Main Contacts 
  

			
	DSM Biomedical	  	Cardiva
	 Account Manager:
	  	Account Manager:
	Tariq Abatis	  	Michael Hendrix
	Sr. Global Account Manager	  	Director, Operations & Supply Chain Management
	Phone: [***]	  	Phone: [***]
	Email: [***]	  	Email: [***]
		
	Send All Complaints To:	  	
	[***]	  	
		
	Quality:	  	Quality:
	Chelsey Calvo	  	Jennifer Lee
	Sr. Quality Engineer	  	Director, Quality Assurance and Engineering
	Phone: [***]	  	Phone: [***]
	Email: [***]	  	Email: [***]
		
	Brianna Schehr	  	
	Quality Assurance Compliance Manager	  	
	Phone: [***]	  	
	Email: [***]	  	
		
	Regulatory:	  	Regulatory:
	Jodi Raus	  	Terry Passarotti
	Sr. Director, Clinical & Regulatory	  	Director of Regulatory and Clinical Affairs
	Phone: [***]	  	Phone: [***]
	Email: [***]	  	Email: [***]
		
	Purchasing:	  	Purchasing:
	Customer Service & Order Processing	  	Michael Hendrix
	Phone: [***]	  	Director, Operations 8 Supply Chain Management
	Email: [***]	  	Phone: [***]
		  	Email: [***]

 Appendix II Revision History 
  

							
	 Version
	  	 Date
	  	 Changes
	  	 
	01	  	18-JULY-2018	  	Initial Release.	  	

  
 Page 1 of 2 

 Confidential 

Quality Agreement of DSM Biomedical and Cardiva Medical, Inc 

Version No.: 01; Issue Date: 07/18/2018 
  

 APPENDIX Il APPROVAL 

On behalf of DSM Biomedical: 
  

							
	Signature:	  		  		  	
				
	Date:	  		  		  	
	Dennis King	  		  	
	Director, Quality Assurance	  		  	
				
	Signature:	  	 /s/ Tim Shannon
	  		  	 /s/ Inne Verhoeven

		  	Signer Name: Tim Shannon	  		  	Signer Name: Inne Verhoeven
		  	Signing Reason: I have reviewed this document	  		  	Signing Reason: I approve this document
		  	Signing Time: 10/23/2018 4:46:50 AM PDT	  		  	Signing Time: 10/29/2018 11.50.38 AM PDT
				
	Date:	  		  		  	
	Tim Shannon	  		  	Inne Verhoeven
	Business Director, Global	  		  	Senior Business Unit Controller
	VP & BM, Global Commercialization	  		  	
			
	On behalf of Cardiva:	  		  	
				
	Signature:	  	 /s/ Jennifer Lee
	  		  	
	Date: 08/28/18	  		  	
	Jennifer Lee	  		  	
	Director of Quality Assurance and Engineering	  		  	
				
	Signature:	  	 /s/ Michael Hendrix
	  		  	
	Date: 08/28/18	  		  	
	Michael Hendrix	  		  	
	Director, Operations & Supply Chain Management	  		  	

  
 Page 2 of 2 

 Confidential 

Quality Agreement of DSM Biomedical and Cardiva Medical, Inc 

Version No.: 01; Issue Date: 07/18/2018 
  

 Appendix III: Example Certificate of Conformance 

 
 

 
 CERTIFICATE OF CONFORMANCE 

Supplier:     DSM Biomedical 
 Address:
    735 Pennsylvania Drive 
 Exton, PA 19341 

Customer:   CARDIVA MEDICAL, Inc 
  

	
	DSM Collagen Patch Part Number
	DSM Lot Number
	Manufacture Date
	DSM Collagen Plug Part Number
	DSM Collagen Plug Lot Number
	Quantity
	CARDIVA Part Number
	CARDIVA P.O. Number

  

					
	 Attribute
	 	 Result
	 	 Specification

	COMPOSITION	 	Pass	 	[***] Collagen
	[***]	 	Pass	 	[***] to [***]%
	[***]	 	Pass	 	[***] to [***]%
	FORM	 	Pass	 	[***]
	PROFILE	 	Pass	 	[***]
	WIDTH OF BASE	 	Pass	 	[***] to [***]
	LENGTH OF BASE	 	Pass	 	[***] to [***]
	[***]	 	Pass	 	[***] to [***]

 DSM certifies that the animal-derived collagen has been sourced and controlled (including ante and post
mortem inspection) in accordance With ISO 22442 Part 2 and is therefore fit for human consumption. 
  

	
	 QC Supervisor Signature
  

	DSM Biomedical
	Date

 Appendix III Revision History 
  

							
	 Version
	  	 Date
	  	 Changes
	  	 
	01I	  	18-JULY-2018	  	Initial Release.	  	

  
 Page 1 of 2 

 Confidential 

Quality Agreement of DSM Biomedical and Cardiva Medical, Inc 

Version No.: 01; Issue Date: 07/18/2018 
  

 APPENDIX IlI APPROVAL 

On behalf of DSM Biomedical: 
 Signature: 

Date: 
 Dennis King 

Director, Quality Assurance 
  

							
	Signature:	  	 /s/ Tim Shannon
	  		  	 /s/ Inne Verhoeven

		  	Signer Name: Tim Shannon	  		  	Signer Name: Inne Verhoeven
		  	Signing Reason: I have reviewed this document	  		  	Signing Reason: I approve this document
		  	Signing Time: 10/23/2018 4:46:50 AM PDT	  		  	Signing Time: 10/29/2018 11.50.38 AM PDT
				
	Date:	  		  		  	
	Tim Shannon	  		  	Inne Verhoeven
	Business Director, Global	  		  	Senior Business Unit Controller
	VP & BM, Global Commercialization	  		  	
			
	On behalf of Cardiva:	  		  	
				
	Signature:	  	 /s/ Jennifer Lee
	  		  	
	Date: 08/28/18	  		  	
	Jennifer Lee	  		  		  	
	Director of Quality Assurance and Engineering	  		  	
				
	Signature:	  	 /s/ Michael Hendrix
	  		  	
	Date: 08/28/18	  		  	
	Michael Hendrix	  		  	
	Director, Operations & Supply Chain Management	  		  	

  
 Page 2 of 2EX-10.26

 Exhibit 10.26 

 

Certain information contained in this document, identified by [***], has been redacted because it is both (i) not
material and (ii) would likely cause competitive harm to the Registrant if publicly disclosed. 

 PROCESSING SERVICES
AGREEMENT 

 

 This agreement (the “Agreement”) is made and entered into upon the date of signature below by and
between the undersigned, (“Customer”), and the provider as set forth in Schedule A (“the PROVIDER”). 
  

	1.0	 Purchase and Sale of Processing Services 

1.1 Purchase and Sale of Processing Services. On the terms and subject to the conditions hereinafter set forth, PROVIDER shall perform for the Customer
such processing services with respect to the products identified in Schedule A (the “Products”) as such schedule is amended in venting from time to time by the parties. The parties agree that the Products be processed by means of
one of the following methods: (i) ethylene oxide gas; (ii) gamma irradiation; (iii) electron beam irradiation: or (iv) x-ray and as set forth in Schedule A. 

1.2 Purchase Price. The prices for processing services rendered by PROVIDER with respect to the Products shall be those set forth in Schedule A,
or otherwise as agreed upon in writing between PROVIDER and the Customer. Prices quoted by PROVIDER do not include taxes or the costs of shipping Products to and from PROVIDER’s Facilities, which shall be borne entirely by the Customer.
Notwithstanding anything herein to the contrary, at any time after the execution of this Agreement, the prices on Schedule A shall be reviewed and may be adjusted by PROVIDER upon [***] advance written notice to Customer. Without limitation
to the preceding sentence, prices for processing services shall be adjusted under the following circumstances: (i) in the event that there is an increase or decrease of more than [***] in the cost of Ethylene Oxide, Cobalt 60 or energy or
(ii) if a regulatory requirement prohibits PROVIDER from providing the processing services in accordance with the processing requirements set forth in Schedule A. In the event that Customer wishes to make changes to its Product treatment
specifications or any procedure as set forth at the time this Agreement is entered into, PROVIDER reserves the right to make appropriate adjustments to this Agreement, including, but not limited to, adjustments to the prices specified on Schedule
A. Except as and only to the extent otherwise specifically set forth herein, title to and risk of loss of the Products shall remain with the Customer at all times. The Customer will be charged separately for the use of PROVIDER’s facilities
to perform validation of processing parameters, at the prices otherwise applicable to processing services sold to the Customer. 
 1.3 Invoices and
Charges. PROVIDER will invoice the Customer for processing services rendered by PROVIDER. Payment of each invoice shall be made by the Customer net [***] of the date of receipt of such invoice. Any amount not so paid shall accrue simple interest
at a rate of [***]% per month from the date of the original invoice for such amount. In the event Customer fails to timely pay any invoice for services rendered, PROVIDER reserves the right, at its option and upon notification of the Customer, to;
(i) refuse to perform further services for the Customer, (ii) perform further services for the Customer only on a COD basis, (iii) withhold the shipment of Product in PROVIDER’s possession until all past due invoices are paid,
and/or (iv) make use of any other remedies legally available to it. In addition to any amounts owed for services rendered, Customer shall also reimburse PROVIDER for any costs incurred in asserting its rights hereunder, including reasonable
attorneys’ fees. 

 

	2.0	 Performance of Processing Services 

2.1 Processing Requirements. PROVIDER shall process Products in accordance with the parameters for such Products set forth in the attached Schedule
A. The parties may modify the processing requirements for any Products at any time, and they may agree upon additional processing requirements for new Products, provided however, that no processing requirements, modifications or additions shall
become effective and binding upon the parties until they have been agreed upon in writing and signed by both parties. The processing requirements agreed upon by the parties, together with such modifications or additions as may be agreed upon from
time to time, shall be set forth in Schedule A, Customer shall notify PROVIDER of any changes in the composition of or materials in the Products or their packaging. Any increase costs arising out of any Customer changes shall be the
Customer’s sole responsibility. 
 2.2 Validation of Processing Requirements. The Food and Drug Administration requires, and Customer agrees,
that Customer shall have exclusive responsibility for the validation of processing requirements for Products prior to the commencement of commercial distribution of such Products. The Customer acknowledges and agrees that it is solely and
exclusively responsible for the validation of processing, product sterility, the integrity of product packaging and the adequacy of product labeling. 
 2.3
Shipment of the Products by the Customer. Customer shall ensure that the Products will assemble without overhang on 40 inch x 48 inch pallets, unless otherwise specified in Schedule A.
Non-conforming Products shall be accepted in PROVIDER’s sole discretion. Customer will assemble the Products on pallets and the Products shall be accompanied by documents setting forth the facility from
which the Products are shipped, the number of shipping cartons in the shipment by product code and pan number or catalog number, the date of the shipment and the type of processing required. Upon receipt of a shipment, PROVIDER will complete a
receiving report on the shipment If each batch count received is not identical to that shown on shipping papers as having been shipped by Customer, PROVIDER shell notify Customer of any discrepancy and it shall be Customer’s responsibility to
locate the lost material and, if necessary, to notify the appropriate government agencies. No material in any batch is to be processed, and the provisions of Section 2.4 shall not apply, until both parties are in agreement as to the exact
count. Customer agrees to supply PROVIDER with [***] copies of a material safety data sheet (“MSDS”) complying with 29 CFR 1900.1200(g) with the first shipment of any hazardous chemical to PROVIDER, and with the first shipment following
each and every revision to the MSDS. Upon PROVIDER’s signed receipt of shipment, PROVIDER will be responsible for the total count of the Products including biological indicators (test packs) while said Products are in PROVIDER’s
possession. 
 2.4 Records of Processing. PROVIDER shall assign a number to each processing batch of the Products. This number will be recorded by
PROVIDER, along with the name of the Products, the number of units of Products, the date on which such Products are processed, the type of processing used and the processing chamber used. Records of PROVIDER’s processing of the Products will be
maintained by PROVIDER for a period of [***] from the date of the processing and will be available for inspection upon request by representatives of federal or state regulatory agencies. 

2.5 Shipment of the Products by PROVIDER. PROVIDER shall cause the Products to be shipped in accordance with Customer’s written instructions. When
shipping the Products, PROVIDER shall include documents specifying the name of the Products, the number of units of the Products, and the lot number. Unless agreed upon in writing, PROVIDER shall not be required to break up multiple-pallet loads or
individual pallets prior to shipment. 

 

  
 1. 

 2.6 Storage of the Products by PROVIDER. PROVIDER shall store the Products on its premises for a period
of up to [***] beyond the business day when the Products are processed for a daily storage fee as set forth in Schedule A. Unless otherwise specified in Schedule A, the Customer agrees that pallets stored by PROVIDER may be
“doubled-stacked.” If PROVIDER has not received written instruction regarding the shipment of the Products by the expiration of the [***] period after the completion of processing, PROVIDER shall be free, at PROVIDER’s option, to
(i) continue to store the Products on its premises at PROVIDER’s pricing specified in Schedule A (ii) cause the Products to be stored at an outside warehouse selected by PROVIDER, with all shipping and storage costs to be borne
by the Customer, or (iii) ship the Products to the Customer at the Customer’s expense. 
 2.7
Non-Sterile Markings. Customer agrees that it will ship each pallet, carton or other designated unit of the Products completely covered and conspicuously marked to show its “non-sterile” nature. The Product marking must be sufficiently secure to prevent its accidental removal prior to release of the Products from quarantine by the Customer. After the completion of the
process, PROVIDER will conspicuously mark each pallet, carton or other designated unit to indicate the articles have been treated and that they have not been released from quarantine until such time as the units are so released. Customer agrees that
it will leave this label attached to each pallet, carton or other container in quarantine until it has received a certificate of specification compliance from its testing laboratory. 

2.8 Compliance with Laws. 
 (a) Each of the parties agrees
at all times to conduct its operations in compliance with the applicable requirements of 21 CFR Part 801.150 (“Medical Devices: Processing, Labeling or Repacking”), 21 CFR Part 820 (“Quality System Regulation: General”), or any
successor regulations as well as any other applicable laws and regulations. 
 (b) CUSTOMER ACKNOWLEDGES THAT THE STATE OF CALIFORNIA HAS DETERMINED THAT
ETHYLENE OXIDE IS A CARCINOGEN AND A REPRODUCTIVE TOXIN, AND THAT IT IS SO LISTED UNDER CALIFORNIA’S SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT OF 1986 (“PROPOSITION 65”). THE PRESENCE OF ETHYLENE OXIDE OR OTHER GAS RESIDUES IN THE
PRODUCTS FOLLOWING PROCESSING MAY REQUIRE WARNING LABELS UNDER PROPOSITION 65 OR SIMILAR “RIGHT TO KNOW” LAWS IN OTHER STATES. CUSTOMER AGREES TO COMPLY WITH ANY AND ALL FEDERAL, STATE AND LOCAL LABELING REQUIREMENTS. 

 

	3.0	 Confidential Information. 

Each of Customer and PROVIDER acknowledges that in the course of performing its obligations pursuant to this Agreement, it may obtain certain confidential
and/or proprietary information belonging to the other party, its affiliates or customers. Subject to the exceptions set forth hereinafter, each party agrees that all information communicated to it by the other parry shall be received in strict
confidence, shall be used only for the purposes of this Agreement and shall not be disclosed by the receiving party, its agents or employees without the prior written consent of the disclosing party, except as may be necessary by reason of legal or
regulatory requirements beyond the receiving party’s reasonable control. This obligation of confidentiality shall survive termination of this Agreement but shall not apply to information which is (i) publicly known or becomes publicly
known through no act of the receiving party; (ii) rightfully received from a third party; (iii) independently developed; or (iv) already known to the receiving party. Each party agrees that any information disclosed to it by the other
party prior to the execution of this Agreement shall be subject to and governed by the terms of this section. 
  

	4.0	 Limited Warranty; Liability for Product Damage; Warranty Disclaimer; Limitation of Liability

 4.1 Limited Warranty 

(a) PROVIDER warrants to the Customer that it will process the Products in accordance with the parameters referred to in Schedule A and in accordance
with PROVIDER’s quality policy manual in effect when the Products are processed. Notwithstanding the foregoing warranty, the Customer acknowledges that many factors beyond PROVIDER’S control can affect the ultimate microbiological
condition of the Products. Among these are the quality, type and original bioburden of the Products and their packaging, the atmospheric humidity in the packaging room, the configuration of the Products, the material or construction or the Products,
the adequacy of the testing laboratory atmosphere and equipment, the competence of testing laboratory atmosphere and equipment, the competence of testing laboratory personnel, the competence and adequacy of sampling techniques, and the care and
handling of the Products during warehousing and distribution. The Customer acknowledges that the foregoing limited warranty is personal to the Customer and that such limited warranty may be enforced against PROVIDER only by the Customer, and not by
any third party (including, without limitation, Product resellers and end-users). 
 (b) If PROVIDER becomes aware of
any non-conformity with the limited warranty given in Section 4.1(a) (either through its own investigation or through written notice of the Customer) within [***] of shipment from PROVIDER of the Products
subject to the warranty claim, then Customer’s exclusive remedy, and PROVIDER’s sole liability to the Customer, shall be limited to (i) reprocessing such Products at PROVIDER’s expense if the Products are not damaged, or
(ii) if the Products are damaged, indemnifying the Customer for its direct manufacturing cost of any of the Products which are damaged by the processing nonconformance and which need to be replaced, up to an aggregate maximum payment equal to
[***] the processing charge for such Product, as stated in the Schedule A. PROVIDER will reprocess such Products only after receiving the Customer’s written authorization to do so. 

4.2 Product Damage Caused By PROVIDER. If a Product is damaged by PROVIDER as a result of physical mishandling by PROVIDER, then Customer’s
exclusive remedy, and PROVIDER sole liability to the Customer, shall be limited to the amount set forth in Section 4.1(b)(ii). Customer will make every effort to keep cost to minimum by refurbishing and/or repackaging wherever feasible.
Customer must present a written request to PROVIDER for reimbursement for damages under this clause of the Agreement within [***] of the damage occurrence or lose its indemnification rights with respect to the damaged Products. PROVIDER will provide
compensation to Customer within [***] of written notification, provided the damages are not in dispute. 
 4.3 Warranty Disclaimer. PROVIDER MAKES NO
REPRESENTATION, GUARANTY OR WARRANTY, EXPRESS OR IMPLIED, OTHER THAN THE LIMITED WARRANTY CONTAINED IN SECTION 4.1(A), IN PARTICULAR, PROVIDER MAKES NO REPRESENTATION, GUARANTEE OR WARRANTY, EXPRESS OR IMPLIED, CONCERNING THE STERILITY OF THE
PRODUCTS OR DEGREE OF STERILIZATION, NOR AS TO THE MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF PRODUCTS AFTER PROCESSING BY PROVIDER. 
 4.4
Limitation of Liability. IN NO EVENT SHALL PROVIDER BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR OTHER SIMILAR DAMAGES, INCLUDING BUT NOT LIMITED TO DAMAGES ARISING FROM DEATH, BODILY INJURY, PROPERTY DAMAGE
(OTHER THAN DAMAGE TO THE PRODUCTS AS PROVIDED N SECTION 4.1(13)), LOSS OF PROFITS OR REVENUE OR LOSS OF USE OF THE PRODUCTS. SUBJECT TO THE REQUIREMENTS OF SECTION 4.1(B), PROVIDER’S AGGREGATE LIABILITY UNDER OR AS A RESULT OF THIS AGREEMENT
SHALL NOT EXCEED THE GROSS PROCEEDS RECEIVED FROM THE CUSTOMER DURING THE CALENDAR YEAR WHEN THE INCIDENT GIVING RISE TO PROVIDER’S LIABILITY OCCURS.

 

  
 2. 

	5.0	 Term / Termination 

5.1 Year-to-Year Term. This Agreement will commence on the date executed
by Customer (provided the Agreement is also executed by PROVIDER) and will continue for an initial term of one (1) year from such date. After the initial term, this Agreement shall be renewed automatically for successive one year periods unless
Customer or PROVIDER provides written notice to the other parry, at least [***] prior to the end of the initial or any renewal term, that the Agreement shall not be renewed. 

5.2 Termination For Default. If either party is in material default of its obligations under this Agreement, except for PROVIDER’s refusal to
perform pursuant to Section 1.3, the other party may give written notice that the Agreement will be terminated if the default is net cured within [***]. If such notice is given and the default, except for PROVIDER’S refusal to perform
pursuant to Section 1.3, is not cured during the [***] period, then the party not in default shall have the right to immediately terminate this Agreement. 

5.3 Termination Upon Insolvency. This Agreement shall be terminated effective immediately upon delivery of written notice by either party of such
termination if any of the following occurs: (i) the institution by or against a party of insolvency, receivership or bankruptcy proceedings, (ii) such party’s making an assignment for the benefit of creditors, or (iii) the
dissolution of such party. There shall be no opportunity to “curt” nor any requirement for advance notice of termination under this section 5.3. 
  

	6.0	 General Provisions 

6.1 Governing Law. The validity, construction, interpretation and enforcement of this Agreement, or any breach thereof, shall be governed by the laws of
the Stare of Illinois applicable to contracts made and to be performed in that State. Any and all suits as to this Agreement shall be filed in Cook County, Illinois. 

6.2 Indemnification. The Customer agrees to indemnify, hold harmless and defend PROVIDER from and against all settlements, judgments, fines, expenses,
losses, costs, deficiencies, liabilities and damages, including reasonable attorneys’ fees and expenses (collectively, “damages”) incurred or suffered by PROVIDER arising out of or in connection with (i) any breach by the
Customer of any of its covenants or agreements made in this Agreement, (ii) the processing of the Products, except to the extent such damages arise exclusively and directly out of negligent acts or omissions of PROVIDER or PROVIDER’s
failure to process the Products in accordance with the parameters set forth in Schedule A, (iii) any claim that the Products are not sterile, or (iv) any tee claim of personal injury, including death, or other damage arising out of
the use of any and all Products. 
 6.3 Entire Agreement. This Agreement constitutes the final written expression of the terms of agreement between
the parties relating to the subject matter contained herein and is the complete and exclusive statements of those terms. This Agreement supersedes all prior agreements with respect to such subject matter and merges all prior discussion between the
parties. All references to this Agreement shall be deemed to include the schedules hereto. No provision in any purchase order or purchase order confirmation, whether entered into prior to, concurrently with or after the execution and delivery of
this Agreement, shall be effective to the extent that provision is inconsistent with any provision of this Agreement. 
 6.4 Amendments. This
Agreement may be amended only with the consent of both parties hereto in writing signed by an authorized representative of each party. 
 6.5
Severability. The provisions of this Agreement shall be deemed severable, and the invalidity, unenforceability or illegality of any provision of this Agreement shall not in any way affect or impair the validity, enforceability or legality of
the other provisions hereof. 
 6.6 No Waiver. The failure of either party hereto at any time to require performance by the other party of any
provision of this Agreement shall in no way affect the right of such party to require performance of that provision, and any waiver by either party of any breach of any provision of this Agreement shall not be construed as a waiver of any continuing
or succeeding breach of such provision, a waiver of the provision itself or a waiver of any right under this Agreement.

 6.7 Relationship. Each party to this Agreement is an independent contractor, and nothing contained herein
shall be construed to create an agency relationship or partnership between the parties. 
 6.8 Force Majeure. PROVIDER shall not be responsible for
any loss, damages or penalty resulting from delay in processing or delivery when such delay is due to causes beyond the reasonable control of PROVIDER. including but not limited to, labor unrest, utility interruptions, shortages, riots,
insurrection, fires, flood, storm, earthquake, explosion, act of God, war, terrorism, or governmental action. 
 6.9 Insurance. Each party shall
maintain at all times during the term of the Agreement, adequate insurance protecting all the Products while in the party’s control, and in Customer’s case while in transit to and from PROVIDER, from any loss, casualty, or damage. Customer
shall maintain product liability insurance resulting from use of the Products. All insurance shall be in amounts not less than [***] per occurrence and [***] in the aggregate. Customer shall cause PROVIDER to be named as an “Additional
Insured” on all policies of insurance. Any failure by PROVIDER to obtain proof of “Additional Insured” status shall not be deemed waiver of such requirement. Each party shall direct its insurer to notify the other in writing
immediately upon receipt from that party of, or upon the respective insurer’s giving to that parry, any notice relating to the non renewal, cancellation or reduction in coverage of such insurance. 

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

PROVIDER 
 2015 Spring Road, Suite 650 

Oak Brook, Illinois, 60523 
  

			
	Date:	 	4/29/03
	By:	 	 /s/ Marcela Viscarra

	Name:	 	Marcela Viscarra
	Title:	 	Customer Service Administrator
	
	CARDIVA MEDICAL INC
	(Customer Name)
		
	Date:	 	5/15/03
	By:	 	 /s/ Yi Chen

	Name:	 	Yi Chen Ph.D., RAC
	Title:	 	Sr. Director or RA/QA
	Address:	 	2585 Leghorn Street Mountain View, CA 94043
		
		 	  

		 	Hank Zoeller
		 	Cardiva Medical, Inc.
		 	Vice President, Operations
		
		 	 /s/ Hank Zoeller

		 	5/15/03

 
 

  
 3. 

 Schedule A 

Products, Price and Processing Requirements 

For 
 CARDIVA MEDICAL,
INC. 
 Radiation Processing Facility(s): 
 Ion Beam
Applications, Inc [***] 
 Ion Beam Applications, Inc [***] 

EtO Processing Facility(s): 
 Minimum Charge
Requirements: All services provided by PROVIDER shall be subject to the minimum charges set forth below. All processing charges shall be determined based upon product specifications, processing instructions, and requirements as requested by
Customer. Additional charges may apply to product exceeding the specifications, parameters, and requirements as stated herein or as specified on this Schedule A. 
  

	 	•	 Certified production run: $ [***] 

 

	 	•	 Sample Product run [***] (per the parameters set forth hereunder): $[***] per carrier per run.

  

	 	•	 Sample Product material testing run: $[***] per tote. 

Product Specifications - Production: Product not conforming to the description and/or treatment specifications as set forth below shall be separately
agreed upon in writing by the parties. 
  

							
	 Product Description
 and/or Identification
Number
	  	 Processing Requirements

(Dose Range or Cycle)
	  	Carton / Pallet Dimensions	  	Product Density
	Medical Devices	  	[***] to [***]	  	Various	  	Various

 Processing Charge – Production: In the event PROVIDER is required to process Customer’s Product listed above
at a PROVIDER facility other than as specified on this Schedule A, PROVIDER shall honor the pricing as set forth below at any such alternate facility. 
  

							
	Dose Range	  	Price / Tote	  	Effective Date	  	Facility
	[***] to [***]	  	$[***]	  	Upon Signature	  	Corona [***]
	[***] to [***]	  	 1-7 Totes $[***]

8-14 Totes $[***]
 15-21 Totes $[***]
	  	Upon Signature	  	Hayward [***]

 Delivery Times – Production: Subject to Section 2.4 of the Agreement, the following turn-times are for all
orders provided that: (i) the Products and accompanying documentation are acceptable for processing upon delivery; (ii) all Purchase Orders specify delivery times matching those listed on this Schedule A; and (iii) the
volume of Product to be processed is not in excess of the volume forecasted pursuant to Section 2.2 in the Agreement. 
  

					
	 Product Description
 and/or Identification
Number
	  	Dose Range	  	Delivery Time
	Medical Devices	  	[***] to [***]	  	[***]

 Sample Product Radiation Processing Parameters – [***]: (Corona) 

 

							
	 Carrier Dimension
	  	 Maximum Product

Density
	  	 Target Dosage Requirement
	  	 Price/Carrier

	[***]	  	£ [***] g/cc	  	£[***] kGy ± [***]%	  	$[***]
	[***]	  	£ [***] g/cc	  	[***] kGy ± [***]%	  	$[***]
	[***]	  	£ [***] g/cc	  	[***] kGy ± [***]%	  	$[***]

 Sample Product Description: For complete product information pertaining to any given shipment of Customer’s Sample
Product, including, but not limited to, identification and/or catalog number, dosage and processing specifications, and instructions for delivery, please refer to Customer’s purchase order and/or written authorization associated with such
shipment. Sample Product Pricing is based on a PER TOTE charge but Customer WILL NOT be charged for dose mapping. 

  
 A-1 

 Sample Product Radiation Processing Parameters – Production Cell: 

 

									
	 Minimum Dose
	 	 Min/Max Dose Ratio
	 	 Density
	 	 Facility
	 	 Price per tote

	[***]kGy – [***]kGy	 	[***]	 	<[***]g/cc	 	Corona	 	$[***]
	[***]kGy – [***]kGy	 	[***]	 	<[***]g/cc	 	Corona	 	$[***]
	[***]kGy – [***]kGy	 	[***]	 	<[***]g/cc	 	Corona	 	$[***]
	[***]kGy – [***]kGy	 	[***]	 	<[***]g/cc	 	Corona	 	$[***]

 Related / Ancillary Services and Associated Charges: 

 

					
	Dose Map	  	$[***]/ each
	Additional Dosimeters	  	$[***]/ pair
	Storage	  	$[***]/ pallet / day
	Stretch Wrap	  	$[***]/pallet
	Pallets	  	$[***]/ pallet
	Handling Charges (UPS and FedEx shipments)	  	[***]
	Weekend Shipping	  	 $[***] for shipments on Saturday
 $[***] for
shipments on Sunday

	After Hour Shipping (Monday – Friday)	  	$[***]
	Expedited Processing:	  	
	[***]	  	[***] hours	  	$[***]/ Per Tote + standard processing charges
	[***]	  	[***] hours	  	$[***]/ Per Tote + standard processing charges

 ALL STAT SERVICES ARE GUARANTEED OR MONEY BACK ON ALL CHARGES (INCLUDING PROCESSING) 

‡ (Availability is dependent on treatment specifications and time of delivery) 

* PROVIDER guarantees to have the Product in the pre-con room within four hours of receipt 

Special Product Handling (Instructions and Associated Charges): 

Acknowledgment: Provider and Customer hereby acknowledge this Schedule A as a binding attachment to the Agreement between the parties and warrant
that the information contained herein accurately reflects Customer’s treatment specifications and instructions for processing as provided to SteriGenics by Customer for the processing of Customer’s Products and SteriGenics’ charges
associated with said processing. Any and all modifications or amendments to the contents of this schedule shall be by mutual agreement and with the written authorization of both parties. 

 

					
	Dated: 4/29/03	 	Dated: 5/15/03
			
	PROVIDER	 		 	
			
	 /s/ Marcela Viscarra
	 		 	 /s/ Yi Chen

	(Signature)	 		 	(Signature)
			
	By: Marcela Viscarra	 		 	By: Yi Chen, Ph.D., RAC
	Title: Customer Service Administrator	 		 	Title: Sr. Director of RA/QA
			
		 		 	 /s/ Hank Zoeller

		 		 	Vice President, Operations
		 		 	Hank Zoeller
		 		 	Cardiva Medical, Inc.

  
 A-2

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