Informed Consent Form for Kareindia sampling program

Patient Support Disease Management Program

Funding Company: The patient support disease management Program is funded by Bayer Zydus Pharma Pvt Ltd)

Service Provider, acting on behalf of Bayer: Saarathi Healthcare Pvt Ltd

Introduction

You are being invited to take part in this Kareindia sampling program, a patient support disease management program provided by Saarathi Healthcare Pvt Ltd on behalf of Bayer for the patients who are diagnosed with Type 2 diabetes (T2DM) or Diabetes Kidney Disease (DKD) and prescribed Finerenone (Kareindia) by your treating physician.

Please take time to read the following information. This document explains the purpose of this program and what will happen if you take part. Within the scope of this service includes: home delivery of Finerenone (Kareindia) samples as recommended by your doctor. Details of the process flow and registration is provided in the sample card given to you by your doctor. The Finerenone samples and door delivery of the same will be provided free of charge via this program.

It is up to you whether or not you want to take part in this program. If you decide not to participate, this will not affect your standard medical care. Ask your treating doctor/ program contact partner if there is anything that is not clear or if you would like more information.

Program Subject Information

You have been offered the opportunity to take part in this program because you have T2DM or DKD and your doctor has prescribed Finerenone (Kareindia) for you.

The purpose of this program is to: Provide a structured format for proper distribution of samples to patients based on your doctors recommendation. Details of the program, registration and contact information are provided in the sample card provided to you by your doctor.

What will happen with your personal data if you join the program?

Personal Data

If you wish to participate in this program, it will be necessary to handle your personal data in order to run the program. Below, you will be asked to provide your consent for processing of your personal data.

Your data is also processed to ensure high standards of quality and safety of medicinal products and to ensure the scientific integrity of the program.

For this program, “personal data" can include any information relating to you. It may include, for example:

• information to arrange your participation in the program that directly identifies you (such as your name, address, telephone number, health insurance number, age, gender).
• information on your health and medical condition including your medical history.
• your treatments and your response to treatments.

“Handling of your personal data” means collecting, storing, analysing or transmitting your personal data to Saarathi Healthcare Pvt Ltd.

All your personal data is confidential and will only be shared with your treating healthcare professional(s) and their staff and Saarathi Healthcare Pvt Ltd . In addition, some of your personal data may be shared with

• Bayer’s Pharmacovigilance Departments for processing and reporting obligations in the event that you have an adverse event, product technical complaint or usability issue or other safety-related event. Processing of respective personal data may be supported by Bayer entities or service providers in countries that have a different data privacy level than your country. In this case, Bayer will contractually ensure an appropriate data protection level.
• Bayer’s auditors for audit and inspection reasons to ensure the program is run properly.
• Regulatory Authorities to comply with legal requirements like reporting of adverse events, and to make sure the program is run properly.

These people must keep your data private

The service provider will share aggregated data about the program with the funding company to improve patient care; plan future programs; create educational and informative materials; and publish results or presentations. This aggregated data will not identify you.

Retention of your personal data

Your data will be locally stored by the service provider for at least 15 years after the program ends, or longer if needed for the purposes above or legal reasons. Personal data that is sent to the funding company as part of adverse event information or product or quality complaints will be retained according to legal requirements.

Your rights with respect to your personal data

To take part in this program means you need to agree to the collection and handling of your personal data as described above. Once collected, your personal data is required t meet obligations from regulatory health authorities and help develop programs to high standards of safety and quality.

Your personal data are protected by data privacy law which ensures you have the following rights to:

• Withdraw your consent to handle your personal data at any time without having to justify your decision. This would mean that you cannot continue to participate in the program and no further personal data about you will be collected. Please note the data already collected so far based on your initial consent may not be deleted if required for regulatory purposes like adverse event reporting obligations, or to ensure the scientific integrity of the program.
• Request information about the handling of your personal data, a copy of your personal data collected or deletion of your data. Please note, to ensure compliance with regulatory requirements like adverse event reporting obligations, a deletion may not be possible.
• Request correction of your personal data if it is wrong or not complete.
• Request to limit the handling of your personal data. This may mean that you cannot further participate in the program. Where the handling of your personal data is required to fulfill regulatory obligations like adverse event reporting, a limitation may not be possible.
• File a complaint with a data protection authority.

For any information about your data and your rights or if you want to exercise any of your rights with respect to data about you, please address your request to your treating healthcare professional or the service provider- Saarathi Healthcare Private Limited (Saarathi Healthcare), 431/432 Lodha Supremus 2, A wing Road No. 22, Wagale Estate West, Thane – 400604 on the toll free number provided on the patient sampling card

Who to contact for further information

If you have questions about the program, please contact your treating healthcare professional / Saarathi Healthcare. You are encouraged to ask as many questions as you would like so that you can decide if you wish to take part or not.

INFORMED CONSENT FORM

Program title: Kareindia sampling program

Funding company: Bayer Zydus Pharma Pvt Ltd

Service Provider acting on behalf of Bayer: Saarathi Healthcare Pvt Ltd

Patient Declaration

I confirm that

• The treating healthcare professional/ program contact partner has explained the Patient Support disease management program (hereinafter “Program”) to me comprehensively.
• I have had the opportunity to discuss the Program with the treating healthcare professional /Program contact partner and all my questions were answered.
• I have read and understood the Patient Information Form for the program.
• I understand that I will receive a copy of the Patient Information and Informed Consent Form when requested.
• I understand that the service is provided only after the physician’s prescription of Finerenone (Kareindia).
• I understand and agree that I will be provided free sample of Finerenone (Kareindia) as part of the Program. These services will be provided only as per the recommendation by the doctor.
• I understand that the service under the Program are provided free of charge by Saarathi healthcare Pvt Ltd on behalf of Bayer and that Bayer can cancel this Program at any time.
• I understand that my decision to take part in the Program is entirely voluntary. I can decide against a participation in the Program at any time without effect on my standard medical care.
• I agree to participate in the Program as described in the Patient Program Information Form/ patient card.

Declaration concerning data protection

I understand that my consent to the following is the legal basis for processing of my personal data. My consent is voluntary. It will allow my participation in the program. Once my personal data has been collected, it may be required for ensuring high standards of quality and safety of medicinal products and to ensure the scientific integrity of the program.

• I consent to the processing of my personal data as described in the Patient Program Information Form. Personal data include the following sensitive data: health related data
• I agree that in case of any adverse event / product technical complaint / usability issue or other safety and quality related events, necessary data will be forwarded to Bayer’s Pharmacovigilance Department and Regulatory Authorities, as required for reporting purposes.
• I agree that in case of audit or inspection, necessary data will be shared with auditors and/or Regulatory Authorities, as required.
• I am aware that I may withdraw my participation in the program and my consent to the further processing of my personal data without any impact on my standard medical care at any time without justifying my decision. The withdrawal of my consent for processing my data does not affect the lawfulness of processing of my data before the withdrawal.
• I am aware that in case of withdrawal, my already collected personal data may be further processed in accordance with applicable laws, in case it’s required to meet obligations from regulatory authorities.

Disclaimer: This document is prepared as part of the Patient Support Program by Bayer Zydus Pharma Private Limited and to be utilized for the said purpose only. Any unauthorised use or reproduction of this document is strictly prohibited.

Approval number: PP-KER-IN-0100-1