Qmed Consulting A/S • Koebmagergade 53, 1. • DK 1150 Copenhagen K • Tlf.: +45 5664 1010 • Fax: +45 5665 3842 Mail: [email protected] • Bank: Reg.nr. 4865 Kontonr. 10182026 • VAT.No. DK-30564278 Page 1 of 1

State Agency of Medicines Nooruse 1 Tartu 50411 Estonia 29 July 2026

Study title Abbott Structural Heart Device Registry (Abbott SH Registry) – The ENDURE Study

Protocol number ABT-CIP-10415 Sponsor Sponsor: Abbott Medical, 5050 Nathan Lane N, Plymouth, MN

55442, USA Sponsor address in EU

St. Jude Medical Coordination Center BV, Corporate Village Da Vincilaan 1, F1 1935 Zaventem, Belgium

Eetikakomitee taotluse 398/T-10 otsus CIV CIV-EE-25-04-052499

Request for a refund Dear Sir/Madam We would like to request a refund for the State Fee that we have paid in error. We make this request according to § 12-15 of Statutory Fees Act. We have mistakenly paid 210 euros on 20 July 2026 instead of waiting for an invoice from you to pay the correct amount of money. The money was paid for the above mentioned study, where we are requesting an approval for a substantial modification. We attach the proof of payment of the 210 euros paid in error. Could you kindly refund the money to: Qmed Consulting A/S Reference 360.029 Danske Bank Erhverv, Bernstorffsgade 40, 1577 Copenhagen V. Denmark IBAN: DK59 3000 4869 6338 60 SWIFT: DABADKKK We look forward to hearing from you. Kind regards Stephanie John [email protected] +41 79 651 3268

BankDanske

Danske Bank A/S CVR-nr. 61 12 62 28 - København

Danske Bank Business København Bernstorffsgade 40 1577 København V Telefon 45127200 Telefax 45149893 SWIFT-BIC: DABADKKK www.danskebank.dk

Betalingstype: Overf»rsel til udlandet Afsender

Afsenders konto: Qmed EUR 4869633860 EUR

Tekst p} afsenders kontoudskrift: Estonian Compentent Modtager

Modtagers konto: EE932200221023778606 Kontoen f»res i: EE Modtagers navn og adresse: Estonian Compentent Authority Meddelelse til modtager: reference no. 2900083031 Modtagers bank

BIC/SWIFT-adresse: HABAEE2X Navn og adresse: SWEDBANK AS

LIIVALAIA STREET 34 KESKLINNA DISTRICT EE-15040 TALLINN

Bel»b: 210,00 EUR Overf»rselstype: SEPA Instant overf»rsel Ekspeditionsdato: 20.07.2026 Omkostninger: Deles Yderligere oplysninger om betalingen

Gebyr, som afsender skal betale:

Gebyr i alt: 0,13 EUR

Statusoplysninger

Betalingsstatus: Ekspederet

Betalingshistorik

Oprettet: 20.07.2026 af 4A8762 Godkendt: 20.07.2026 af 4A8762 Godkendt: 20.07.2026 af 6F1700

Tekniske referencer

Bankens arkivreferencenummer: 3943609287

Udskrift fra Business Online (CET) 14:15 - 20.07.2026 af 4A8762 - JANNIE MATTSSON

13 59

P

Certificate Of Completion Envelope Id: D91724F1-79B2-85AD-80CA-F1A4423F6B3D Status: Completed

Subject: Complete with Docusign: CRD 1032 SH Registry Cover Letter_refund state fee_29JUL2026.pdf

Source Envelope:

Document Pages: 2 Signatures: 1 Envelope Originator:

Certificate Pages: 5 Initials: 0 Dr. Stephanie John

AutoNav: Enabled

EnvelopeId Stamping: Disabled

Time Zone: (UTC-08:00) Pacific Time (US & Canada)

Baldershøj 17B

Ishøj, Sjælland 2635

[email protected]

IP Address: 217.79.195.251

Record Tracking Status: Original

7/29/2026 1:51:45 AM

Holder: Dr. Stephanie John

[email protected]

Location: DocuSign

Signer Events Signature Timestamp Dr. Stephanie John

[email protected]

Senior Principal advisor

Qmed Consulting A/S

Security Level: Email, Account Authentication (Required), Logged in

Signature Adoption: Pre-selected Style

Signature ID:

AF9CA9FA-387B-418F-9792-9D54F9382F81

Using IP Address: 217.79.195.251

With Signing Authentication via Docusign password

With Signing Reasons (on each tab):

I have reviewed this document

Sent: 7/29/2026 1:54:51 AM

Viewed: 7/29/2026 1:55:03 AM

Signed: 7/29/2026 1:55:18 AM

Electronic Record and Signature Disclosure: Accepted: 10/16/2023 6:33:08 AM ID: 65691f0c-b8ad-4399-8713-86e15313a13c

In Person Signer Events Signature Timestamp

Editor Delivery Events Status Timestamp

Agent Delivery Events Status Timestamp

Intermediary Delivery Events Status Timestamp

Certified Delivery Events Status Timestamp

Carbon Copy Events Status Timestamp

Witness Events Signature Timestamp

Notary Events Signature Timestamp

Envelope Summary Events Status Timestamps Envelope Sent Hashed/Encrypted 7/29/2026 1:54:51 AM

Certified Delivered Security Checked 7/29/2026 1:55:03 AM

Signing Complete Security Checked 7/29/2026 1:55:18 AM

Completed Security Checked 7/29/2026 1:55:17 AM

Payment Events Status Timestamps

Electronic Record and Signature Disclosure

ELECTRONIC RECORD AND SIGNATURE DISCLOSURE

From time to time, Qmed-Consulting A/S (we, us or Company) may be required by law to

provide to you certain written notices or disclosures. Described below are the terms and

conditions for providing to you such notices and disclosures electronically through the DocuSign

system. Please read the information below carefully and thoroughly, and if you can access this

information electronically to your satisfaction and agree to this Electronic Record and Signature

Disclosure (ERSD), please confirm your agreement by selecting the check-box next to ‘I agree to

use electronic records and signatures’ before clicking ‘CONTINUE’ within the DocuSign

system.

Getting paper copies

At any time, you may request from us a paper copy of any record provided or made available

electronically to you by us. You will have the ability to download and print documents we send

to you through the DocuSign system during and immediately after the signing session and, if you

elect to create a DocuSign account, you may access the documents for a limited period of time

(usually 30 days) after such documents are first sent to you. After such time, if you wish for us to

send you paper copies of any such documents from our office to you, you will be charged a

$0.00 per-page fee. You may request delivery of such paper copies from us by following the

procedure described below.

Withdrawing your consent

If you decide to receive notices and disclosures from us electronically, you may at any time

change your mind and tell us that thereafter you want to receive required notices and disclosures

only in paper format. How you must inform us of your decision to receive future notices and

disclosure in paper format and withdraw your consent to receive notices and disclosures

electronically is described below.

Consequences of changing your mind

If you elect to receive required notices and disclosures only in paper format, it will slow the

speed at which we can complete certain steps in transactions with you and delivering services to

you because we will need first to send the required notices or disclosures to you in paper format,

and then wait until we receive back from you your acknowledgment of your receipt of such

paper notices or disclosures. Further, you will no longer be able to use the DocuSign system to

receive required notices and consents electronically from us or to sign electronically documents

from us.

All notices and disclosures will be sent to you electronically

Electronic Record and Signature Disclosure created on: 2/11/2022 5:13:37 AM Parties agreed to: Dr. Stephanie John

Unless you tell us otherwise in accordance with the procedures described herein, we will provide

electronically to you through the DocuSign system all required notices, disclosures,

authorizations, acknowledgements, and other documents that are required to be provided or made

available to you during the course of our relationship with you. To reduce the chance of you

inadvertently not receiving any notice or disclosure, we prefer to provide all of the required

notices and disclosures to you by the same method and to the same address that you have given

us. Thus, you can receive all the disclosures and notices electronically or in paper format through

the paper mail delivery system. If you do not agree with this process, please let us know as

described below. Please also see the paragraph immediately above that describes the

consequences of your electing not to receive delivery of the notices and disclosures

electronically from us.

How to contact Qmed-Consulting A/S:

You may contact us to let us know of your changes as to how we may contact you electronically,

to request paper copies of certain information from us, and to withdraw your prior consent to

receive notices and disclosures electronically as follows:

To contact us by email send messages to: [email protected]

To advise Qmed-Consulting A/S of your new email address

To let us know of a change in your email address where we should send notices and disclosures

electronically to you, you must send an email message to us at [email protected] and in the

body of such request you must state: your previous email address, your new email address. We

do not require any other information from you to change your email address.

If you created a DocuSign account, you may update it with your new email address through your

account preferences.

To request paper copies from Qmed-Consulting A/S

To request delivery from us of paper copies of the notices and disclosures previously provided

by us to you electronically, you must send us an email to [email protected] and in the body of

such request you must state your email address, full name, mailing address, and telephone

number. We will bill you for any fees at that time, if any.

To withdraw your consent with Qmed-Consulting A/S

To inform us that you no longer wish to receive future notices and disclosures in electronic

format you may:

i. decline to sign a document from within your signing session, and on the subsequent page,

select the check-box indicating you wish to withdraw your consent, or you may;

ii. send us an email to [email protected] and in the body of such request you must state your

email, full name, mailing address, and telephone number. We do not need any other information

from you to withdraw consent.. The consequences of your withdrawing consent for online

documents will be that transactions may take a longer time to process..

Required hardware and software

The minimum system requirements for using the DocuSign system may change over time. The

current system requirements are found here: https://support.docusign.com/guides/signer-guide-

signing-system-requirements.

Acknowledging your access and consent to receive and sign documents electronically

To confirm to us that you can access this information electronically, which will be similar to

other electronic notices and disclosures that we will provide to you, please confirm that you have

read this ERSD, and (i) that you are able to print on paper or electronically save this ERSD for

your future reference and access; or (ii) that you are able to email this ERSD to an email address

where you will be able to print on paper or save it for your future reference and access. Further,

if you consent to receiving notices and disclosures exclusively in electronic format as described

herein, then select the check-box next to ‘I agree to use electronic records and signatures’ before

clicking ‘CONTINUE’ within the DocuSign system.

By selecting the check-box next to ‘I agree to use electronic records and signatures’, you confirm

that:

 You can access and read this Electronic Record and Signature Disclosure; and

 You can print on paper this Electronic Record and Signature Disclosure, or save or send

this Electronic Record and Disclosure to a location where you can print it, for future

reference and access; and

 Until or unless you notify Qmed-Consulting A/S as described above, you consent to

receive exclusively through electronic means all notices, disclosures, authorizations,

acknowledgements, and other documents that are required to be provided or made

available to you by Qmed-Consulting A/S during the course of your relationship with

Qmed-Consulting A/S.