Takeda’s Patient Assistance Program (Adcetris®)

Statement of Medication Necessity (SMN) Application

TREATING PHYSICIAN NAME* CONTACT (E-mail, Phone) *

HOSPITAL NAME AND ADDRESS

TREATING PHYSICIAN SPECIALTY*
(“Organization”) *

PATIENT INFORMATION (hereinafter referred to as “Patient”)

Name*
Address*
Email ID*
Telephone* Cell: Home:
Date of Birth (DD/MM/YYYY) * Weight (kgs)*
DIAGNOSIS AND TREATMENT

Previously Untreated Stage III or IV Classical Hodgkin Lymphoma

Classical Hodgkin Lymphoma Consolidation

Relapsed Classical Hodgkin Lymphoma (after failure of auto-HSCT or after failure of at least two prior multi-
Patient Diagnosis* agent chemotherapy regimens)

Previously Untreated Systemic ALCL or Other CD30-expressing Peripheral T-Cell Lymphomas

Relapsed Systemic ALCL (failure of at least one prior multi-agent chemotherapy regimen)

Relapsed Primary Cutaneous ALCL or CD30-expressing Mycosis Fungoides

Prescribed Treatment* Total recommended cycles: ________/Year No. of Vials: _____________/ Cycle

Dosage* Medication* Adcetris® (Brentuximab vedotin)

For Treating Physician, by signing below, I certify that:

(a) I understand and acknowledge that I have been briefed by Axios International Consultants Limited (the “Axios”) about the Takeda’s Patient Assistance Program for Adcetris (the “Program”),
which is run, managed, and implemented by Axios International and sponsored by Takeda Biopharmaceuticals India Pvt Ltd. (the “Takeda”). I confirm that as per the applicable laws and internal
policies / protocols of the Organization the Program can be implemented in the Organization. (b) I am the treating physician of the Patient and have been duly authorized by the Patient / Patient’s
legal guardian (as applicable) to release the above-referenced Patient information and other protected health information of the Patient for the purpose of seeking assistance in initiating or
continuing medication / therapy and/or the evaluation of the Patient’s eligibility for prospective enrolment in the Program; Axios can contact the patient upon receiving my consent and obtain
duly signed consent from the patient for further process. (c) The above medication / therapy is medically necessary for the Patient, and I have independently judged and analyzed that the Patient
medically qualifies for the medication / therapy as per the locally approved indications in India. My judgement also suggests that a patient needs this support program to complete his/her course
of treatment because of his/her financial constraints. (d) Any free of charge medication vials (the “FOC Vials”) received by the Patient through the Program will be used solely for the Patient
enrolled in the program. (e) I agree to report any Adverse Event that may occur to the Patient if enrolled in the Program and to provide related clinical data of the Patient (if requested);(f) I
understand and agree to comply with the Program guidelines and have informed the Patient / Patient’s legal guardian that Takeda at its sole and absolute discretion, reserves the right to modify
or discontinue the Program at any time; (g) I acknowledge and agree that Axios may verify the accuracy of the submitted information and seek utilization confirmation certificate duly signed by
me and Patient / Patient’s legal guardian confirming the utilization of the FOC Vials for the Patient ((h) I have provided the Patient / Patient’s legal guardian with full information about the treatment,
its benefits, and its known risks. (i) I understand that it is a mandatory requirement to complete and submit a new signed consent form for patients who are prescribed the treatment for more
than 16 Cycles, and I agree to provide written justification. (j) I confirm that I have no financial interest in this Program and have not been offered to promise, authorize or accept any payment or
give anything of value, either directly or indirectly to any public official, regulatory authority or other stakeholder for the purpose of influencing, inducing or rewarding any act, omission or decision
in order to secure an improper advantage, or obtain or retain business through the Program. (k) I hereby authorize Axios International to collect, store, use, transfer, disclose or otherwise process
(the “Process” and/or “Processing”) my personal data, such as full name, occupation, telephone number(s), email, place of employment, which is voluntarily disclosed as mentioned above and/or
collected throughout the Program for the purposes of the Program (the “Purposes”). I understand that my personal data will be kept as long as necessary for the fulfilment of the Purposes, as
further mentioned below, and in order to comply with all applicable legal, regulatory, scientific, or other requirements. I understand that Axios International maintains appropriate physical,
administrative, and technical safeguards to protect my personal data from loss, misuse, unauthorized access, disclosure, alteration and/or destruction. (k) I furthermore agree that Axios International
may transfer my personal data for the same Purposes to Takeda, or Axios International’s affiliates located outside of India. I consent to my patient to be enrolled on the Program to participate in
Patient Reported Outcome Survey as per program process and reports can be shared with me or other medical fraternity on requests. (l) I understand that I may at any time ask to be provided
with information as to my personal data stored by Axios International and/or its affiliates and require correction, deletion or blocking of any incorrect data. In such case, or if I have any enquiries
or would like to submit any complaint about privacy practices of Axios International or wish to revoke my consent, I should send a written request, including my name and contact information
(e.g., telephone, email address, mailing address) to Axios International at: [email protected] Axios International will respond to such requests within thirty (30) business days. (m) I understand
that I am free to amend or limit my consent, upon written intimation sent to Axios International, to the email ID [email protected]

I understand that signing this consent form is voluntary and I confirm having read, understood, and agreed to its content in full before signing below.

Preferred method to receive updates and frequency E-mail Phone MyPatients app Major Events Monthly Never

Prescriber’s Name & Signature: _________________________ Date: ___________________

1 Any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which does not necessarily have to have a causal relationship with this treatment.
An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding or lack of expected pharmacological action), symptom, or disease associated with the use
of a medicinal product, whether or not related to the medicinal product.

C-ANPROM/IN/ADCE/0004
Takeda’s Patient Assistance Program (Adcetris®)
Statement of Medication Necessity (SMN) Application

For Patient/ Patient Guardian- I, hereby, undertake and acknowledge the following by signing this form:

a) That I had allowed my treating physician to release the above-referenced information and other protected health information including my health insurance plan (as applicable) to Axios
International Consultants Limited (the “Axios”) and I had agreed to be contacted by the Axios program manager for potential enrolment into the Takeda’s Patient Assistance Program for Adcetris
(the “Program”); (b)I have been informed by my treating doctor about treatment with Adcetris®) so giving self- declaration of my limited affordability to complete prescribed course of treatment
and wish to receive financial assistance in form of FOC vials though Adcetris Patient Assistance Program; (c) I hereby authorise Axios International to collect, store, use, transfer, disclose or otherwise
process (the “Process” and/or “Processing”) my personal data which is voluntarily disclosed and/or collected for the purposes of assessing my eligibility for potential enrolment in the Program (the
“Purpose”). Personal data about me may include my name, home address, telephone number (s) and email ID, information about my health – including medical diagnosis, medical tests, medication
and treatment, medical appointments as may be disclosed by me and/or at a later stage by my treating physician or a next of kin authorised by me for purposes of my proper eligibility assessment,
potential enrolment and management in the Program; (d) I understand that my personal data will be kept by Axios International as long as necessary for the fulfilment of the Purpose, as further
discussed below, and in order to comply with all applicable legal, regulatory, scientific, or other requirements. I understand that Axios International maintains appropriate physical, administrative,
and technical safeguards to protect my personal data from loss, misuse, unauthorized access, disclosure, alteration and/or destruction; (e) I agree that Axios International may transfer my personal
data with respect to implementation of the Program or as may be required under the applicable laws to health authorities, NGO partners, pharmacies, or authorized distributors involved in the
Program or affiliates of Axios International outside of India; to countries which may not always provide the same level of protection but for which Axios International and/or its affiliates have taken
appropriate steps to ensure that any anonymized data is adequately protected; (f) I understand that I may at any time ask to be provided with information as to my personal data stored by Axios
International and/or its affiliates and require correction, deletion or blocking of any incorrect data or withdraw my consent. In such case, or if I have any enquiries or would like to submit any
complaint about privacy practices of Axios, I should submit a written request, including my name and contact information (e.g., telephone, email address, mailing address) to Axios at:
[email protected], Axios will respond to such requests within thirty (30) business days; (g) I understand that I am free to withdraw my consent to personal data processing at any time with
future effect also I understand that my participation in the Program is voluntary, and I shall be entitled to withdraw it at any time by giving a written intimation to to Axios, to the email address:
[email protected] ;(h) My personal data and health information will be used to help apply to, check eligibility criteria for the Program as well as for tracking medications received within the
Program; (i) There is no guarantee that I will be eligible for the Program and my enrolment in the Program will be solely subject to compliance with Program eligibility criteria and completion of
documentation for enrolment in the Program. I further understand the result of my eligibility under the Program will be kept confidential by Axios and may only be disclosed to my treating
physician by Axios.; (j) I agree to comply with the Program guidelines shared by Axios with me and understand that the sponsor of the Program i.e., Takeda Biopharmaceuticals India Pvt Ltd. (the
“Takeda”), at its sole and absolute discretion, reserves the right to modify or discontinue the Program at any time without requirement of providing notice or information to me; (k) I agree to
share the proof of purchase of Adcetris medication vials and treating physician’s prescription with Axios. Or any other proof for my commercial purchase if needed; (l) I agree to issue the following
duly signed documents as required under the Programme: a duly signed undertaking upon receipt of FOC Vials from the designated distributor and a duly signed FOC Vials utilization confirmation
letter / medication release letter post infusion of FOC Vials; (m) I agree to report any Adverse Event to Takeda or Axios team in India and allow them to contact my treating physician to obtain
more details about Adverse Event, if needed. I also allow Axios to anonymously report any Adverse Event to Takeda Biopharmaceuticals India Pvt Ltd (the “Takeda”) that may be identified by Axios
during my interactions within the Program; (n) All information provided by me as a part of the Program may be verified by Axios through the request of additional documentation and I shall
provide due support in this regard. In case any information or documents are false, Takeda at its sole discretion has the right to exclude me from the Program, without requirement of providing
notice or information to me; (o) If I receive free medication as a part of the Program, I will use it as my doctor has prescribed and will not sell or distribute any free medications. I understand that
violation of this obligation will result in losing my access to the Program; (p) This consent form remains in effect until my participation in the Program ; This consent form remains in effect for 1
(one) year upon date of signature specified hereinbelow; (q) I understand that it is a mandatory requirement to complete and submit a new signed consent form should I need to continue
treatment up to 16 Cycles based on my physician’s prescribing orders; (r) I consent to participate in Patient Reported Outcome Survey as per program process; (s) All information that I have given
to Axios and will give to Axios in the future as part of the Program, is and will be complete, true and accurate to the best of my knowledge.

I hereby indemnify Axios and Takeda of any liability arising due to any incorrect information provided by me.

Preferred method to receive updates and frequency Email Phone MyHealth app Major Events Monthly Never

Patient / Patient’s legal guardian’s Name: __________________________________________________________________

Patient / Patient’s legal guardian’s Signature: _________________________________ Date: ______________________

1 Any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product, which does not necessarily have to have a causal relationship with this treatment.
An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding or lack of expected pharmacological action), symptom, or disease associated with the use
of a medicinal product, whether or not related to the medicinal product.

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C-ANPROM/IN/ADCE/0004