Consent Form for Participation in a Patient Training Program

For the Use of ILUMYA 100MG/ML

This document constitutes a Consent Form for participation in a support program for patients using the preparation: ILYMYA 100MG/ML, produced by: Taro International Ltd., and supplied by S.L. Nursing Services Ltd. ( hereinafter, “the Plan”, “Registrant” and “the Company,” respectively).

It is hereby clarified that you are under no obligation to join the program, and you may choose to stop/suspend receiving the service unconditionally at any time.

The program’s purpose is to provide patients who have been prescribed treatment with ILYMYA 100MG/ML the required support and guidance in connection with taking ILUMYA 100MG/ML, to facilitate patient’s involvement and allow them to maintain a proper treatment routine.

Please read this document carefully before making a decision and giving your consent to participate in the program. If you agree to participate in the program, please sign the Consent Form in the place marked below.

Please note: The program does not constitute medical advice and is not intended to replace or change in any way the existing medical treatment, medical advice, administration instructions, guidelines or any other assistance you receive from your attending physician.

:The Offered Services

The services the Company offers to you as part of the program (hereinafter – the “program’s services”) are:

(1) Training by a qualified nurse regarding the method of injection of ILUMYA 100MG/ML. This would follow the actual receipt of an appropriate prescription from the attending physician and subject to the dispensing of the said preparation ( hereinafter – “Training Service”).

(2) Follow-up calls and provision of additional services in accordance with this Consent Form to improve patients’ compliance with the administered medication: ILUMYA 100MG/ML.

:Explanation About the Training Service

The service is provided by Company employees who have received an appropriate training and/or professionals designated for the program (hereinafter – the “Company Representative“). As part of the training service, a Company’s certified nurse will provide individual training of about 1 (one) hour at your home or in another location convenient for you, or via telephone/video call. During the training, you and/or your caregiver/s will acquire the skill to inject ILUMYA 100MG/ML independently. The training service should assist you in using the preparation correctly and conveniently, making it easier for you to comply with the treatment.

It is recommended that during the training you shall perform a self-injection of ILUMYA 100MG/ML in the presence of the nurse.

To receive the training service, the preparation must be in your possession during the appointment. Lest there be any doubt, it is hereby clarified that the responsibility for purchasing the preparation and its storage in accordance with the instructions rests solely with you.

I, of my own free will and for the purpose of joining the program, agree to participate in the program and give my consent :

1. The Company, via the Company’s Representative, may collect and process my personal data, document and manage the service, and register my personal data in a database owned by the Registrant, operated by the Company in accordance with the law, in a database numbered 700070805, which is managed and held by the Company.
2. It has been made clear to me that the Company undertakes to comply with the provisions of any laws regarding the protection of patient privacy and the possession and management of databases, as stated in the Privacy Protection Law, 5741 – 1981 – and its directives. If I wish to add, correct or delete information from the database, I would need to call the service center at 1700-555 282.
3. I am aware and agree that the Registrant or the Company may contact me regarding the treatment with ILUMYA 100MG/ML via phone calls, SMS messages or e-mail. The communication frequency with me shall be determined according to my request and needs, and, from time to time, to coordinate training and receive information regarding the treatment, document and manage the service, whether during the program or after its completion.
4. I know that my participation in the program is not a substitute for treatment and medical follow-up, as explained to me by the attending physician. I know that it is my responsibility to independently check with the attending physician the dates for performing tests, follow-ups and prescription renewal.
5. I authorize the attending physician to provide the Company Representative with details concerning the program, and this for the purpose of managing and documenting the service.
6. I authorize the Company to provide information to the Registrant and/or to a third party for the purpose of statistical analyses performed on the data collected as part of the program and without identifying my personal details.
7. It has been explained to me that as a result of the treatment there is a chance that I will experience adverse effects. Should that occur, I was advised by the Company Representative to contact the attending physician according to the matter detailed in the consumer leaflet.
8. I am aware and agree that a report I send to the Company concerning adverse effects and/or quality complaints related to the use of ILUMYA 100MG/ML shall be forwarded by the Company to the Registrant, who will record the report in its databases in accordance with the provisions of the law. Also, if necessary, the Registrant shall be entitled to report such information to the authorities anonymously, in accordance with any law. The report shall include my personal identifying details only subject to my consent.
9. I agree that the Registrant or someone on their behalf will contact me after reporting adverse effects, in order to receive additional information about the report.
10. I allow the Registrant to contact my attending physician and/or the institution where I am being treated and receive details regarding the adverse effects that have been reported as part of the program.
11. If/When the Company Representative feels there is a danger to my health, I agree they may contact my attending physician on my behalf and document that application. Lest there be any doubt, this should not detract from the recommendation to establish direct contact with the care provider.
12. I know that my phone calls with the hotline will be recorded for the purpose of quality control and service improvement, and all according to the law.
13. I allow the Registrant to listen to the recordings and/or conversation notes between the Company Representatives and me, with regard to reporting adverse effects only, and without further need for prior notification on behalf of the Registrant.
14. As part of my participation in the program, I authorize my attending physician to provide the Company, via the Company Representative, the details required for the provision of the program’s services. This includes details about changes to my medical condition, side effects, details concerning the way of taking the treatment, my dealings with the treatment, and this for the purpose of managing and documenting the provision of the service.
15. Subject to my consent in the Service Component Selection Form, in the patient training program for the use of ILUMYA 100MG/ML , the appendix to this consent form, I agree that the Company will provide personal and relevant medical information necessary for the provision of the program’s services to my medical team, which includes the date the treatment started, ended, the reason for stopping the treatment, compliance indicators and results of Quality-Of-Life Questionnaire measures, as these are validated, hospitalizations and adverse effects . I know that disagreeing with the transfer of information does not disqualify me from participating in the program.
16. I know my consent to participate in the support program is of my own free will. I am not obligated to sign this form; there is no connection between my consent to participate in the support program and my medical treatment.
17. I understand that I may terminate my participation in the support program at any time by sending a message to phone number 1700-555-282.
18. I know there is no guarantee that the service will be available at all times and that the registrant reserves the right to change the scope of the program and its dates or terminate the program by giving notice to the program participants 30 days in advance.
19. The information that I will be asked to provide as part of the program and to participate in it, as well as for the purpose of reporting possible adverse effects, is, among other things:

• Personal details – name, ID number and date of birth.
• Contact details – phone, address, e-mail URL, best time to contact.
• Name of attending physician and medical institution.
• Details regarding the dosage and treatment of ILUMYA 100MG/ML prescribe it to me.
• Any detail or data that I choose to provide to the Company, or that will be relevant for the purpose of increasing and improving my response to the administered treatment and/or strengthening and improving my awareness of treatment.
• Information I provided in response to questionnaires forwarded to me by the Company Representative, such as how often I forget to take my medications or whether I have ever chosen not to take my medication.
• Details of the conversations/appointments had with the professional training team, including their content.
• Details transferred from the attending physician, relating to the training or the management and provision of services in the program.

20. It is possible that during the provision of the service I will be asked to provide additional relevant information for the purpose of providing the service. I know that I am not obliged to provide information and I do so of my own free will and with my consent. However, providing the information is necessary so that the provision of the program’s services would be possible.
21. I hereby declare that I have read and understood the above in full and that I was given the opportunity to ask the Company Representative questions about the service and the use that can be made of my personal information.

The Patient’s Signature

I hereby declare and/or confirm, as the case may be:

• I am 18 years old or older, and I am qualified to sign this agreement according to the laws of the State of Israel.
• I am being treated with ILUMYA 100MG/ML, in accordance with the physician’s prescription and have read the consumer leaflet provided with the medication.
• All of the above was explained to me in this letter of consent. I understood the nature of the program and the meaning of my signature below and I agree to join the program, in accordance with the above conditions.

Service Component Selection Form – As Part of the Patient Training Program for Using ILUMYA 100MG/ML

Please mark the service components you are interested in and confirm with your signature below

I, the undersigned, agree to the marked service components. It has been made clear to me that not agreeing to one of the sections, shall not prevent my participation in the program.