Jakavi ICF - 13th May 2024

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Patient Informed Consent Form (ICF)

UMAANG Access Program for Jakavi

UMAANG Access Program for JAKAVI® (“Program”) is a patient support program offered by Novartis Healthcare Pvt.
Ltd. to facilitate improved health outcomes for qualified patients through better disease management. The term
Novartis includes Novartis Healthcare Private Limited (NHPL), its affiliates and authorized representatives.

TATA 1MG Technologies Private Limited is the administrator of the Program (Administrator): its employees and/or
agents handle your Personal Data, which is processed in accordance with applicable privacy laws and Novartis
privacy/data protection standards. You will be notified should the administrator of the Program change and your
Personal Data will continue to be protected with equivalent safeguards. For purposes of this ICF, the term
Administrator shall include TATA 1MG Technologies Private Limited, and any other party designated by Novartis as
administrator of the Program.

The following personal data is required from you to provide you the Program Services

Patient Name

Patient Date of Birth

Patient Age
Patient Gender □ Male/ □Female/ □Other
Patient Mobile Number

Patient Residential Address

City
State
Pin code
Patient e-mail
Patient Identification & address proof attached □Aadhaar/ □Driving License/ □Passport/ □Voter’s ID
(please tick).
Note: If patient residential address is different
from address on ID provided, please submit Other (pls specify): ........................................
proof of patient residential address (e.g.,
patient’s or Family Member’s utility bills, etc.).
Kindly select () if Patient is interested □ To know more about third party funding options, example:
Central or State funding, trust funds, Railways,
Employee State Insurance Corporation (ESIC), Private
Insurance, Microfinancing options etc.*

(* We would like to bring to your kind notice that the information


provided is available in public domain and collected basis the
secondary research. Although care has been taken in collating
and computing the information, the Administrator and/ or
Novartis should not be held responsible or held liable in any way
for any inaccuracies and the information not being latest as on
date. This is a service to provide information. No assurance or
guarantee is provided herein for any funding/ loan/ financing by
any of the bodies/institutes/ trusts/ organizations etc. Availing
funding from any of the source is voluntary and any disbursal
thereafter will be as per the eligibility rules, policy and discretion
of the funding institution or body. Our endeavor is to support

IN2405089451
Patient Informed Consent Form (ICF)
UMAANG Access Program for Jakavi
patients by providing this useful information to best of our
abilities. Neither Novartis nor the Administrator are agents of any
institutions/ organizations and they do not have any interest,
financial or otherwise, in making this information available or
funding being provided by any of the institutions/ bodies/ trusts

The language of interaction preferred by me is □ English □ Hindi □ Marathi □ Gujarati □ Punjabi


please select () at least one of the options
provided below: □ Tamil □Telugu □ Oriya □ Kannada □ Bengali

Please tick ( ) the box as applicable: □ Self-Pay1 □Reimbursement2

1. Self- Pay: Patient is not beneficiary either through


reimbursement or coverage from any government or private
insurance/ program directly or through my family member for the
treatment prescribed by my health care physician.
2. Reimbursement: Patient is a beneficiary of any government
health scheme
Name and Contact Number of Person
authorized to collect the free Jakavi®
Signature of Person authorized to collect the
free Jakavi®
If family member is providing this information on behalf of the patient, then please sign the authorization
(available at the end of the consent) as well as provide the following information.
Family Member Name
Family Member Mobile Number
Family Member email ID
Family Member Identification & address proof □Voter’s ID □Aadhaar/ □Driving License/ □Passport/
attached (please tick).

Other (pls specify): ........................................

By enrolling in the Program and submitting this consent form, the patient hereby:

1. Acknowledges and consents to information, such as full name and contact information (phone, address, email),
demographic information (i.e., date of birth, age,), medical/health information including diagnosis information,
KYC documents, photographs, and other information as mentioned in the table above that is necessary to
effectively implement the program (collectively “Personal Data”) being collected and processed for the following
purposes.

a. communicate with you,


b. provide you with the Program’s services such as enrolment and administration of the Program (e.g.,
sharing program benefits, disease counseling, periodic reminders on medication, sharing educational
content, well being counselling vouchers, dispensation and delivery of the medicines when ordered
and as applicable among other services (collectively “Services”)),
c. provide updates regarding the Program,
d. audit or monitor the Program,
e. perform certain activities as required or permitted by law, including to process and report adverse
events (“AEs”) and

IN2405089451
Patient Informed Consent Form (ICF)
UMAANG Access Program for Jakavi
f. to comply with any legal requirements or court order.
g. Novartis/Administrator may contact you at the contact information you have provided; email, phone
or other, including to gauge the status of the patient’s wellbeing post dropout every 30 days for a
period of 6 months after the last prescription of Novartis drug. Only relevant personnel from
Novartis/Administrator will have access to your Personal Data.

2. Acknowledges that Personal Data may be collected from and disclosed to health care professionals, insurance
providers or other third parties, as needed for the Program’s administration and Services. Novartis/Administrators
or their third-party providers are contractually obliged to appropriate data protection and security requirements.
In the case of AE processing and reporting to regulatory authorities, if monitoring or auditing is performed, or if
required and/or permitted by law, it may be that Novartis employees or agents will have access to your Personal
Data. The Administrator will communicate key safety and regulatory information, from time to time, as required
under the law. They will also need to share the contact information of the treating physician with Novartis, to
enable them to seek further details on any AEs reported by you to enable reporting of adverse events under the
law.

3. Acknowledges that Personal Data may be de-identified (replace identifying data with a code or label), aggregated
(combined with other data) or anonymized to conduct analyses for commercial, research, audit, review, and
monitoring purposes. Analyses are performed to help Novartis/Administrator to improve our offers and services
such as this Program, treatment reimbursement, disease educational campaigns, online communications and,
may be conducted using digital capabilities. Your Personal Data may be stored or processed outside of India,
including for AE processing and reporting requirements. In such case, Novartis ensures that your Personal Data
is protected. Your Personal Data may be subject to the laws of foreign jurisdictions, with a different level of
protection than your country of residence.

4. Acknowledges that she / he / they may revoke her / his / their consent at any time. Withdrawing consent will result
in the termination of participation in the Program and its Services and no new Personal Data will be collected,
The patient may withdraw consent, request access to information about their Personal Data, correct or erase their
Personal Data, raise a grievance, or nominate an individual who can exercise these rights on behalf of the patient
by contacting the {Administrator Privacy Officer} at 1800 3000 1030 or [email protected] manner
in which the patient may make a complaint to the Data Protection Board of India will be communicated at a later
date when it is prescribed under the relevant rules.

5. Understands that Personal Data collected under the Program will be retained for five (5) years from the date of
Program closure. The file containing your Personal Data will be maintained for monitoring and regulatory
purposes, de-identified, aggregated, or anonymized data may continue to be used as described above. During
this retention period, necessary steps will be taken to ensure that the information is protected and kept confidential
in line with the Administrators Privacy Policy available at https://www.1mg.com/PrivacyPolicy

6. Acknowledges that the Program has been explained to the patient/Family Member in a language they understand
and that participation in this program is voluntary.

7. Represents and warrants that the information provided in connection with the patient’s enrolment in this Program
is true and correct, and understands that any incomplete, inaccurate, or misleading information may result in
rejection or termination of the patient’s enrolment in this Program. Patient further undertakes to immediately inform
the Administrator should the patient later learn of any inaccuracies, or should there be significant changes, in the
Personal Data submitted.

IN2405089451
Patient Informed Consent Form (ICF)
UMAANG Access Program for Jakavi
8. Acknowledges and understands that the Administrator will not sell, share, or otherwise transfer personal data to
third parties other than third parties authorized by the Administrator for the purpose of administering the Program.

9. Acknowledges that Novartis reserves the right to vary, amend or terminate the Program at any time.

10. Agrees that the terms and conditions and the patient’s participation in the Program shall be governed and
construed in accordance with the laws of India. Any claims or disputes arising in relation to the Programs shall be
subject to the exclusive jurisdiction of the courts in Mumbai.

11. Agree to provide video, AADHAAR or other government-issued ID Proofs, as part of Know Your Customer (KYC,
physical or electronic) validation process implemented by the Administrator.

I hereby CONSENT to Administrator processing my personal data for the purposes stated above.

______________________________________
Patient Signature and Date

Authority Letter
To be completed if the patient consent form is being filled by the Family Member1

(1-Family Member will mean related to patient or their spouse by blood or marriage but not limited to, a child,
stepchild, grandchild, parent, stepparent, grandparent, spouse, sibling, mother-in-law, father-in-law, son-in-
law, daughter-in-law, brother-in-law, or sister-in-law, including adoptive relationships)

I, Ms/ Mr./ Mx. _____________________________ am the _________________________ of the Patient, have gone
(Family Member’s name) (Relationship to Patient)

through/been explained the terms & conditions of the UMAANG Access Program for JAKAVI®. Having understood
the same, I am desirous of enrolling the patient Mr./ Ms./ Mx. ....................................................................... (Patient’s
Name) under the Program. Due to the patient’s current medical condition, the patient himself/ herself is unable to
enroll under the Program. Hence, I, as the patient’s authorized representative, hereby agree to and authorize the
patient’s enrolment in the Program. I also consent to the processing of my Personal Data for the purposes mentioned
above.

I acknowledge that I am above 18 years of age and attached herewith is the patient’s and my own identity and address
proof.

Yours sincerely,

___________________________
Signature and Date

IN2405089451

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