Tpap

Axios International Consultants Limited ("Axios") is committed to protecting your personal data and upholding applicable data protection laws and regulations, including but not limited to the Personal Data Protection  Law Nº 13.709/2018, its implementing rules and regulations, and other applicable laws (as amended or replaced from time to time) protecting the privacy of your Personal Data ("Laws").

For the purposes of this Privacy Notice for Takeda Patient Assistance Program (the "Privacy Notice"), "Personal Data" means any information relating to a person, which enables the identification of such person, whether directly or indirectly, as defined by the Laws and as described below.

We therefore would like to inform you about the collection, use, disclosure, transfer and/or processing (collectively refer to as "process" or "processing") of your Personal Data below and ask for your consent for certain processing.

For more detailed information on how Axios processes personal data, please refer to Axios’ Privacy Policy at www.axiosint.com/privacy-policy.

1. The Purpose of Processing Your Personal Data

Axios (and any third party who may be acting on our behalf) may process your Personal Data on: (i) your consent, (ii) contractual basis for our initiation or fulfilment of a contract with you, (iii) legitimate interests, for the purpose of our legitimate interests and the legitimate interests of third parties, to be balanced with your own interests, fundamental rights and freedoms in relation to the protection of your Personal Data, (iv) our legal obligations to which we are subject, (v) vital interest, preventing or suppressing a danger to a person's life, body or health, and (vi) the reason for the establishment of, and defence against, legal claims in the future, for the following purposes:

1.1  To review your application to Takeda Patient Assistance Program (PAP)

1.2 To conduct a financial evaluation

1.3 To contact you for the purposes of the PAP, which may include but are not limited to, provision of program information, coordination of program supported medication and tracking

1.4 To comply with legal or regulatory obligations that apply to Axios;

1.5 To carry out our legal and contractual obligations to you, including when you contact us for feedback, information and support;

1.6 To carry out market or consumer studies, identify and analyse business and usage trend, improve and develop Axios' business;

1.7 To protect our rights, property, safety, or operations or those of any of you or others; and

1.8 To allow us to pursue available remedies or limit the damages that we may sustain, and to establish, exercise or defend our legal rights or for the purposes of legal proceedings.

Axios may also aggregate the Personal Data which are obtained from you with data obtained from other sources in order to obtain a summary that will be used to improve Axios' business.

2. Types of Personal Data which will be Collected and How the Personal Data is Collected

The Personal Data collected by Axios includes information about you that you give to us by communicating with us, whether face-to-face, by phone, via email, or online. Such information may include, but is not limited to:

2.1  Identification information, such as your title, first name, family name, nick name, gender, age, date of birth, account information, and any information that you choose to share with us, which may be considered Personal Data;

2.2 Contact information, such as your phone number, mobile number, fax number, address, email address, company email address, business phone number, business address, and social media profiles;

2.3 Health information, namely, medical diagnosis, medication and treatment, medical appointments, and information released by your treating physician; and

2.4 Recordings and/or photographs of you, such as your video recording, audio recording, digital pictures and/or other photographs.

2.5 Financial information, such as salary confirmation, bank statements, proof of insurance, electricity and water bills, school or educational bills, telephone and/or cell phone bills, car ownership or lease documents, employment contract, and/or home rental contract or home purchase documents

3. How Axios Uses Your Personal Data and With Whom Axios Shares Your Personal Data

3.1 Axios processes and discloses your Personal Data only for the purposes set out in this Privacy Notice.

3.2 Axios may also share your Personal Data with other third parties for the purposes set out in this Privacy Notice, including, among others: health authorities, charity partners, pharmacies or distributors involved in the PAP, law enforcement agencies, government authorities, and external advisors.

3.3 Axios may also share anonymized data, for the purposes set out in this Privacy Notice, to Axios entities outside of Brazil, in countries which may not always provide the same level of protection.

4. Retention Period

Axios shall retain your Personal Data for 10 years after the declaration of the end of the project/accounting period or after you have ended your participation in the Program, whichever is shortest, for the above-mentioned purposes and as required by the Laws.  After this period, your personal data will be securely destroyed in a secure manner. Takeda will retain aggregated data about the Program for as long as is required.

If a judicial or disciplinary action is initiated, your Personal Data may be stored until the end of such action, including any potential period for appeal, and will then be deleted or archived as permitted by the Laws.

5. How will your personal data be protected?

Axios´s data privacy policy ensures that the patient private and confidential information handling is proceed based on applicable international and local standards or best practices. Confidential patient data is received via a secure and encrypted communication channel and stored electronically in a secure digital environment. To protect your privacy, an identification code will be assigned to identify you within the scope of the program. The code will be assigned by an authorized program staff from Axios International and will be anonymously used within Axios and external parties.

In the case of an Adverse Event, where the patient is the reporter, Axios may share your name and telephone contact upon your authorization for Takeda's pharmacovigilance for the sole purpose of obtaining further details on this Adverse Event, if necessary.

Axios staff is responsible to access your personal data and sensitive data and has been duly trained with respect to the applicable contractual, legal and administrative obligations. The obligation of confidentiality of the provider survives even after the corresponding legal or commercial relationship has ended.

6. Your Rights as a Data Subject

You have the following rights to manage your Personal Data as a data subject.

6.1  You may withdraw your consent for Axios to Process your Personal Data at any time.

6.2 You may access and request for a copy of your Personal Data which falls within the responsibility of Axios. Axios will respond to such requests within 30 business days.

6.3 You may request for your Personal Data from Axios where Axios has rendered your Personal Data into a format which can be generally read or used with machinery or equipment which works automatically, and whereby the Personal Data can be used or disclosed through an automatic function. In such case, you have the further right to;

6.3.1 Request Axios to send or transfer your Personal Data which has been rendered into such format to another data controller where this can be done through an automatic function; or

6.3.2 Request for the Personal Data which has been rendered into such format and which Axios has sent or transferred to another data controller directly, except where this cannot be done because of the technical requirements.

6.4 You may have the right to object to certain collection, use and disclosure of your Personal Data, such as objecting to direct marketing.

6.5 You may request Axios to delete or destroy your Personal Data, or to anonymize your Personal Data, in the following circumstances:

6.5.1 It is no longer necessary to store your Personal Data for the purposes provided under this Privacy Notice; or

6.5.2 You have withdrawn your consent for Axios to Process your Personal Data and Axios has no legitimate authority to continue to Process your Personal Data.

6.6 You may request Axios to suspend using your Personal Data in the following circumstances:

6.6.1 Axios is in the process of reviewing your request to ensure that your Personal Data is accurate, up-to-date and complete, and is not misleading; or

6.6.2 It is no longer necessary to store your Personal Data in accordance with the purposes provided under this Privacy Notice but you have requested for the Personal Data to continue to be stored by Axios in order for you to use your Personal Data for the benefit of your legal rights.

6.7 You may request Axios to ensure that your Personal Data is accurate, up-to-date and complete, and is not misleading.

6.8 You may make a complaint in the event that Axios contravenes or fails to comply with the requirements of the Laws.

7. Inquiries and Complaints

If you have any enquiries or would like to submit any complaint about Axios’ privacy practices, please send a written request, including your name and contact information (e.g. telephone, email address, mailing address) to Axios at: privacy@axiosint.com.

8. How to contact Axios?

Takeda does not receive any directly identifiable information about you; therefore please do not contact Takeda directly.

Axios can be contacted at tpap.brazil@axiosint.com or by telephone at +55 11 98251 3015.

Please always be careful when sending personal data over the Internet. Make sure to only include relevant and necessary information and verify the recipient’s address before sending. When responding to a request for information, always verify that you know the requester. In case of any doubt, call your Program Manager to verify they have requested information.

Acknowledgement and Consent Form for the Privacy Notice for Takeda Patient Assistance Program