Surmodics Particulate Performance Guarantee Terms and Conditions

These Surmodics Particulate Performance Guarantee Terms and Conditions, together with the terms of the mutual confidential disclosure agreement between the parties, govern the particulate comparison program described below for purchase orders that are issued by Customer to Surmodics in accordance with the terms herein during the period from the Effective Date through December 22, 2026 (the “Program”). The Program is offered by Surmodics, Inc. or the Surmodics affiliate identified in the applicable quotation (“Surmodics”) to the customer identified in the signature block below (“Customer”). To the extent that a term in an order, acceptance, or other document issued by either party conflicts with a term under this Program, the term in this Program shall control. The “Effective Date” of the Program is the later of (i) the date of Customer’s signature below, and (ii) the effective date of a mutual confidential disclosure agreement between Customer and Surmodics; provided, however the Effective Date shall be on or before December 22, 2026.

1. Program Purpose

The Program will provide Customer with a controlled, device-specific comparison of particulate generation from an eligible Surmodics hydrophilic coating and a Qualified Competitive Coating subject to the Approved Protocol.

The Program does not purport to establish and shall not be construed to establish that a Surmodics coating has the lowest particulate count for a particular device, coating, manufacturing process, test method, or use condition.

2. Guarantee

If the results of tests on Competitive Samples submitted by Customer to Surmodics for testing under the Program have Lower Particulate Generation than Surmodics Samples prepared and tested by Surmodics under the Program, then Surmodics will waive the Surmodics-quoted charges for the Program under the Surmodics quote.

3. Definitions

“Approved Protocol” means the written test protocol prepared by Surmodics for Customer’s advance approval under the Program.

“Competitive Samples” means the Matched Devices supplied by Customer under the Program without charge to Surmodics that include a Qualified Competitive Coating.

“Lower Particulate Generation” means that the Competitive Samples satisfy the prespecified primary particulate endpoint under the criteria specified in the Approved Protocol with respect to the Surmodics Samples.

“Matched Devices” means devices of the same design and material configuration, including the same device type, design revision, dimensions, geometry, substrate, coated length or surface area, and other characteristics identified in the Approved Protocol that are provided by Customer without charge to Surmodics.

“Qualified Competitive Coating” means a non-Surmodics hydrophilic coating applied by Customer or a third party to a Matched Device.

“Surmodics Samples” means uncoated Matched Devices supplied by Customer to Surmodics for coating and testing under the Program.

4. Eligible Customers and Eligible Surmodics Coatings under the Program

The Program is available to Customers that evaluate Surmodics Samples that include a hydrophilic coating identified in this Section 3. Surmodics may decline to quote or decline to prepare one or more Surmodics Samples under a Program if Surmodics determines that the devices, samples, comparator, timeline, method, resources, legal restrictions, or safety considerations are not suitable for a reliable comparison between a Competitive Sample and a Surmodics Sample or Customer fails to approve an Approved Protocol.

The hydrophilic coating technologies of Surmodics available for Customer’s evaluation under the Program are Preside™ UV-cured coatings, Serene™ UV-cured coatings, or HydroBond™ thermal-cured coatings. Only one Surmodics hydrophilic coating technology shall apply to each Program. Customer may participate in one or more Programs.

5. Qualified Competitive Coating

Customer may blind Competitive Samples provided Customer discloses information reasonably required to establish comparability, safety, testing, and protocol design under an Approved Protocol.

6. Device and Sample Requirements

Customer shall provide at least three uncoated Matched Devices for Surmodics to prepare a Surmodics Sample; however, Surmodics recommends five to ten (5-10) uncoated Matched Devices. Customer shall provide at least five (5) Competitive Samples to Surmodics for testing under the Program.

ALL INFORMATION, PROTOCOLS, COMPETITIVE SAMPLES, MATCHED DEVICES, SURMODICS SAMPLES, AND RESULTS UNDER A PROGRAM SHALL BE CONSIDERED CONFIDENTIAL INFORMATION UNDER THE APPLICABLE MUTUAL CONFIDENTIAL DISCLOSURE AGREEMENT BETWEEN THE PARTIES, (i) IS PROVIDED "AS IS," AND (ii) NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, REGARDING THE ACCURACY, COMPLETENESS OR PERFORMANCE THEREOF, AND EACH PARTY EXPRESSLY DISCLAIMS ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT AND TITLE.

7. Approved Protocol

The Approved Protocol shall control and document, as applicable: device type and revision; substrate; geometry; coated surface area and length; surface preparation; coating application; packaging; sterilization method and dose; aging; storage; hydration and conditioning; simulated-use model; number of passes or cycles; collection and filtration method; particle-counting method; particle-size categories; sample size and lots; controls; data-exclusion rules; statistical analysis; practical-performance threshold; coating-integrity assessment; lubricity, durability, and other functional criteria; reporting; and permitted deviations.

8. Program Exclusions

The Guarantee does not apply if: (a) samples submitted by Customer as Competitive Samples under a Program are not Matched Devices or include a Surmodics coating; (b) Customer does not approve an Approved Protocol prior to Surmodics tests under the Program; (c) Customer information is inaccurate or incomplete; (d) Competitive Samples, Matched Devices, or both that are submitted by the Customer were mishandled, modified, contaminated, expired, improperly stored, or improperly processed prior to Surmodics’ receipt; (e) Customer supplies insufficient quantity or information about the Competitive Samples, Matched Devices, or both; or (f) the results are invalid or inconclusive as defined in the Approved Protocol.

9. Governing Law

The Program shall be governed by the laws of the State of Minnesota, without regard to conflict-of-laws principles.

10. Initiate a Program

To initiate a confidential evaluation under the Program and a mutual confidential disclosure agreement between the parties, Customer shall (a) submit a copy of these Program terms signed on behalf of Customer, (b) provide Surmodics with sufficient technical information on a confidential basis to prepare an accompanying Approved Protocol; (c) request a quote for Surmodics Samples; (d) submit Matched Devices and Competitive Samples in accordance with an Approved Protocol; and (e) submit a purchase order for the Program outlined in a written quote prepared by Surmodics for Customer’s advance approval.