TOLVAPTAN PROGRAM PRIVACY STATEMENT FOR CANADA (“PRIVACY STATEMENT”)

Effective Date: [DATE]

You care about the protection of your Personal Information – and so do we. We work to maintain the privacy and security of the Personal Information you disclose to us when you use this Tolvaptan product website ([INSERT URL TO TOLVAPTAN SITE]) (“Site”) or which we otherwise receive in connection with your participation in the Tolvaptan Program. The Program and this Website are operated by [insert entity], our Patient Support Service Provider, on behalf of Lupin Pharma Canada Ltd. (“Lupin,” “Company” “we,” “us,” or “our”), the manufacturer of Tolvaptan.

This Privacy Statement (“Statement”) applies to Personal Information that the Program collects, uses, or discloses, including when you visit our Site. This Statement only applies to residents of Canada.

Please read this Statement carefully. If you have any questions about this Statement or how we handle Personal Information in connection with this Site or the operation of the Tolvaptan Program, please contact us at complianceandethicsoffice@lupin.com

WE MAY MODIFY THIS STATEMENT AT ANY TIME. ALL CHANGES WILL BE EFFECTIVE IMMEDIATELY UPON POSTING TO THE SITE. MATERIAL CHANGES WILL BE CONSPICUOUSLY POSTED ON THE TOP OF THIS STATEMENT, ON THE WEBSITE OR OTHERWISE COMMUNICATED TO YOU.

PLEASE SEE SECTION 11 BELOW FOR INFORMATION ABOUT YOUR DATA PRIVACY RIGHTS.

FOR QUEBEC RESIDENTS: IN ADDITION TO THE RIGHTS IN SECTION 11 BELOW, PLEASE SEE SECTION 12 BELOW FOR INFORMATION ABOUT ADDITIONAL PRIVACY RIGHTS THAT MAY APPLY TO YOU AS A RESIDENT OF QUEBEC.

IF YOU PROVIDE PERSONAL INFORMATION WITH REGARD TO A POTENTIAL ADVERSE REACTION TO TOLVAPTAN, PLEASE SEE OUR PHARMACOVIGILANCE PRIVACY STATEMENT AT http://www.lupinpharma.ca/privacy WHICH DESCRIBES HOW WE COLLECT, USE AND DISCLOSE PERSONAL INFORMATION YOU PROVIDE OR RECEIVE IN CONNECTION WITH A REPORT OF A POTENTIAL ADVERSE REACTION.

1. WHAT INFORMATION DOES THIS PRIVACY STATEMENT COVER?

This Statement applies to Personal Information of Canadian residents that the Tolvaptan Program collects, uses, and discloses to third parties in connection with the Tolvaptan Program. Personal Information means information about an identifiable individual. Personal Information does not include government records, de-identified or aggregated information, or other types of information excluded from the definition of Personal Information under Canadian law.

2. PERSONAL INFORMATION WE COLLECT

Healthcare Professional Information. If you are a healthcare professional, we may collect information about your occupation, your professional license information and the province in which you work.

Patient Information. Patients can log into the patient support portion of this Site using an anonymous code that cannot be tied to any specific person. Lupin will not receive any Personal Information in connection with a patient’s use of the Site.

Adverse Event (Pharmacovigilance) Information. If we receive a report of an adverse event through the Site, we will collect certain Personal Information as required by Canadian law. Personal Information collected in connection with an adverse event is subject to the privacy statement for our Pharmacovigilance program at http://www.lupinpharma.ca/privacy rather than this Privacy Statement.

Contact Information. If you contact us, we may collect your name, address, and/or e-mail address.

3. SOURCES OF PERSONAL INFORMATION

We collect Personal Information from the following sources:

Source 1: Information that you provide or that is provided on your behalf: We collect Personal Information and other data that you or others may provide on your behalf when using our Site and when you communicate with us.

By way of example, we may collect Personal Information when you log into the Site. If you are a healthcare professional, we will ask you for your occupation, your license number, and the province in which you work.

Source 2: Information automatically collected through technology: We may collect limited device and browser information when you visit our Site through the use of cookies. Cookies are small text files containing a string of characters that is sent and sometimes temporarily stored on your device. The cookies used on the Site are strictly necessary to load and provide you with the ability to access and use the Site. Disabling these cookies may interfere with your ability to use the Site.

4. HOW WE USE PERSONAL INFORMATION

We may use the categories of Personal Information listed in Section 2 above for the following business purposes:

As Stated or Agreed to at the Point of Collection. We may use Personal Information for the purposes stated or agreed to (or as is obvious) at the point of collection. For example, we use Personal Information to respond to communications from you. We may also use Personal Information as requested or consented to by you.

Operation of our Business. We use Personal Information collected from healthcare professionals when they log into the Site to understand the demographics of healthcare professionals visiting the Site.

Website Management. We use Personal Information collected from healthcare professionals when they log into the Site to audit our Site for compliance, authorize access, and secure the Site.

To Protect Our Rights and Comply with Our Legal Obligations. We may use Personal Information collected from healthcare professionals when they log into the Site as necessary to comply with our legal and regulatory obligations.

For Drug Safety and To Meet Our Regulatory Obligations. We use Personal Information collected from healthcare professionals when they log into the Site for drug safety purposes and to meet our regulatory obligations.

5. DISCLOSURE OF PERSONAL INFORMATION

We will only disclose Personal Information to those working on our behalf in a manner consistent with this Statement, other applicable privacy statements or notices, with access controlled as needed, and as explicitly permitted or required by applicable laws, rules and regulations.

  • Patient Support and other Service Providers

We partner with patient support service providers and other service providers located in Canada (both inside and outside Quebec) to assist us in meeting our operational, legal, and regulatory requirements in connection with the operation of the Tolvaptan Program. We maintain written agreements with our service providers which require compliance with applicable data privacy laws. For instance, these service providers may collect Personal Information when they interact with patients or their healthcare providers, when answering questions about Tolvaptan or in connection with the operation of the Tolvaptan Program.

  • We may transfer, communicate, or disclose Personal Information with the following parties, in compliance with this Statement and applicable laws:

Service Providers. We may transfer Personal Information to our service providers. For example, we may share Personal Information with service providers that host and manage the Site; operate the Tolvaptan Program, provide data processing services and support the operation and security for the Site. Uses and transfers of Personal Information by service providers acting on our behalf are governed by agreements that require Personal Information to be treated as confidential and protected in accordance with the data privacy laws.

Professional Advisors. We may make your Personal Information available to our professional advisors, such as our attorneys, accountants, financial advisors, and business advisors, in their capacity as advisors to Lupin.

Government Officials / Law Enforcement. We will cooperate with law enforcement and other governmental agencies, and may disclose Personal Information: (i) if we believe in good faith we are legally required to disclose that Personal Information, (ii) if we are advised to disclose Personal Information by our legal counsel, or (iii) when necessary to identify, contact or bring a legal action against someone who may cause or be causing harm to, or interfering with the legal rights of Lupin, our service providers or any other party.

Change in Ownership. In the event Lupin is the subject of a due diligence process concerning the sale of all or part of the Company, if the Company is a participant to a sale, merger or acquisition transaction or in the event of a bankruptcy, receivership or a similar transaction, we may provide Personal Information to the prospective or subsequent owner(s). In these circumstances, we may share Personal Information with actual or prospective purchasers or successors, and we may transfer your Personal Information to them in the case that a transaction is completed.

Other. We may disclose Personal Information with third parties or service providers when explicitly requested by or consented to by you, or for the purposes for which you disclosed the Personal Information to us as indicated at the time and point of the disclosure (or as was obvious at the time and point of disclosure).

6. CONSENT

We will request your consent to collect and use your Personal Information, except where we are permitted or required to use or disclose your Personal Information under applicable laws or regulations. We may obtain your express consent, or we may obtain your permission based on implied consent. Implied consent is consent that can be reasonably inferred. For example, we infer your consent for us to collect a healthcare professional’s Personal Information when that professional logs into the Site. You may change or withdraw your consent, subject to certain legal, regulatory and contractual exceptions, by contacting us as described in this Statement.

7. SECURITY AND CONFIDENTIALITY

We use commercially reasonable administrative, technical, and physical safeguards designed to secure Personal Information against unauthorized access, acquisition, loss, misuse, or alteration. If a breach of your Personal Information occurs, we will notify you if required under applicable law.

8. USE OF DE-IDENTIFIED INFORMATION

Our Program service provider may de-identify and aggregate Personal Information so that it is no longer considered Personal Information under applicable laws. Lupin may collect, use, share, transfer, and otherwise process de-identified and aggregated information that it receives or creates for any purposes in its sole discretion, in compliance with applicable laws. Lupin is the sole and exclusive owner of such de-identified and aggregated information.

9. INFORMATION FROM CHILDREN

The Site is not directed at children and is designed for individuals who are 18 years of age or older. If you are a parent or guardian that has knowledge that we have collected Personal Information from your minor child, please contact complianceandethicsoffice@lupin.com to request removal and we will endeavor to verify the identity of any applicable child Personal Information and make commercially reasonable attempts to delete such Personal Information.

10. THIRD-PARTY WEBSITES

This Statement applies only to our Site and not to third-party websites. We may provide links on our Site to third-party websites not owned or controlled by us. We are not responsible for third parties’ privacy statements or practices. This Statement does not apply to any third-party websites or to any data that you provide to third parties. You should read the privacy statement for each website that you visit.

11. YOUR PRIVACY RIGHTS

This Section provides an overview of your privacy rights under Canadian law, subject to identity verification requirements and certain exceptions:

Right to Access. You have the right to confirm that we hold Personal Information about you, receive an explanation about how we use your Personal Information, and obtain access to your Personal Information.

Right to Rectification. You have a right to examine and challenge the accuracy of your Personal Information.

Right to Withdraw Your Consent. You have the right to withdraw your consent to processing your Personal Information at any time, subject to legal or contractual restrictions and reasonable notice. If your withdrawal of consent implicates the quality of our services to you, we will notify you.

Right to Complain to a Data Protection Authority. You also have the right to lodge a complaint regarding the processing of your Personal Information with the applicable data protection authority. Please contact your local data protection authority for more information.

How to Exercise Your Rights. To exercise your privacy rights described in this Section, you may submit your request to us by contacting us at any of the following:

Mail:
Attn: Compliance & Ethics Office Americas and EMEA
Lupin Pharma Canada
1111, St-Charles Street West, Suite 550
Longueuil, Quebec J4K 5G4

Email: complianceandethicsoffice@lupin.com

12. ADDITIONAL TERMS APPLICABLE TO QUEBEC RESIDENTS ONLY

If you are resident of Quebec, Quebec law provides you with additional rights regarding the use of your Personal Information, subject to identity verification requirements and certain exceptions.

Right to Restriction of Processing. You have a right to direct us to cease disseminating your Personal Information or to de-index any hyperlink attached to your name that provides access to the information by a technological means, if the dissemination of the information contravenes the law or a court order.

Right to Request Deletion. You have a right to request that we delete Personal Information we collected from you. We will comply with such requests, and direct our service providers to do the same, subject to certain exceptions permitted by applicable law.

Right to Portability. You may request copies of the Personal Information you have provided to us. Where possible, we will deliver the copy of your Personal Information to you using a structured, commonly used, and machine-readable format. Alternatively, you may request that we send your Personal Information to another business.

How to Exercise Your Rights. To exercise your rights described in this Section, you may submit your request to us by contacting us at any of the following:

Mail:
Attn: Compliance & Ethics Office Americas and EMEA
Lupin Pharma Canada
1111, St-Charles Street West, Suite 550
Longueuil, Quebec J4K 5G4

Email: complianceandethicsoffice@lupin.com

Translations. This Privacy Statement may be provided in several languages. In the event of conflict or inconsistency, the English language version of this Privacy Statement controls, unless otherwise required by applicable law. En cas de conflit ou d’incohérence, la version anglaise de cette politique de confidentialité contrôlé, sauf si la loi applicable l’exige.

13. CONTACT

We seek to constantly improve how we manage the collection and use of Personal Information. If you have questions regarding this Privacy Statement or how we treat your Personal Information, please contact us by:

Mail:
Attn: Compliance & Ethics Office Americas and EMEA
Lupin Pharma Canada
1111, St-Charles Street West, Suite 550
Longueuil, Quebec J4K 5G4

Email: complianceandethicsoffice@lupin.com

Consult your doctor with any questions about your disease and your treatment, or to find out if the advice on this website is appropriate for you.

For more information on LUPIN-TOLVAPTAN, call toll free: 1 844-587-4623