Pharmacovigilance Privacy Statement

PRIVACY STATEMENT FOR PHARMACOVIGILANCE ACTIVITIES

Effective Date: October 5, 2026

1. What is Pharmacovigilance and what is Lupin’s obligation?

Pharmacovigilance is defined by the World Health Organization ("WHO") as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”

Pharmaceutical companies have a responsibility of reporting and analyzing adverse drug experiences associated with their marketed products to regulatory authorities worldwide per the country specific reporting obligations for continuous benefit risk assessment of the products. To comply with its reporting requirements, Lupin has set up a system for patients, health care providers, and other individuals to report an adverse event associated with Lupin products. For contact information please see Section 8 below.

2. What does this Statement cover?

This PV Privacy Statement ("Statement") describes how the American affiliates of Lupin Limited/India, which act as Marketing Authorization Holders and/or Distributors for medical products ("Lupin", "we", "us", or "our"), collect, use and disclose your personal information for activities that are related to pharmacovigilance as appropriate and required by applicable regulation. The scope of this statement relates only to how we collect, use, and disclose your personal information collected for our pharmacovigilance program and to protect patient safety.

Please see our Lupin Privacy Statement and our Consumer Health Data Privacy Statement for more information about how we process personal information and the rights you may have regarding the use of your personal information.

Lupin Limited has designated Lupin Pharmaceuticals Inc, Lupin Inc. and Novel Labs Inc. as its representative for Pharmacovigilance in the USA.

3. What personal information do we collect from you?

To meet our pharmacovigilance obligations, Lupin may collect, use and disclose the following categories of personal information about you:

Contact information, such as your name, phone number, email address and home address
Other personal details, such as your date of birth, age, gender, weight, height, marital status or relationship to a person
Records of customer service calls
Job title and professional qualifications
Health information (physical or mental), such as medical history including medical diagnostic results, laboratory test reports or relevant laboratory data, and medication received, accident and injury reports, disability status genetic information or health risk factors
Racial or ethnic origin

We collect this information from you directly when you contact us via letter, fax, telephone, email and in person, or from a health care provider, relative or other third person in relation to your care.

For example, data is collected through forms that you complete, from correspondence with you, or through meetings, calls or other communications that may take place.

4. Why do we collect and use your personal information?

We collect and use your personal information for the reasons set out below:

With your consent:
- Where you have provided us with your express consent to process your personal information for a particular purpose
For operation of our business and communications with you:
- To respond to requests for medical information or product information
- For reporting, assessing and processing of adverse events
- For the elaboration of studies, market research on our products and product developments, in which case the data will be pseudonymized
- Determination of suitability for certain products, services or programs
- To improve our products
- To administer our contracts with service providers
Where necessary to comply with legal obligations such as:
- Monitor and report on product safety and quality
- Administration and legal maintenance of product registries (where required under applicable laws)
- Management of adverse events, including investigating the adverse event and contacting you for further information on the adverse event that you have reported or was reported on your behalf
- Provision of reports to authorities with respect to the safety of a Lupin product
- Responding to court orders, subpoenas or other legal processes with which Lupin is required to comply
- Complying with legal, regulatory and other requirements under applicable U.S. federal and state laws

5. With whom do we disclose your personal information and why?

We may disclose identifiable or pseudonymized personal information for the purposes described above.

Pseudonymization is a method that allows companies to switch the original data set (for example, e-mail, or a name) with an alias or pseudonym. It is a reversible process that deidentifies data but allows the re-identification later if necessary. We disclose pseudonymized personal information with government agencies for pharmacovigilance purposes.

We have offices and operations in several international locations, and we may disclose your personal information with our group companies, service providers, and business partners as part of our pharmacovigilance activities and for business and administrative purposes. Your information may be shared with our internal staff located outside of the United States for pharmacovigilance and administrative purposes, as outlined above. Please visit https://www.lupin.com/about-us/global-presence to see a list of the locations within our corporate group.

Specifically, Lupin may disclose your personal information in an identifiable or pseudonymized format with the following third-party recipients:

Recipient	Purpose
National and/or international regulatory, enforcement, public body or courts where we are required to do so by applicable law or regulation or at their request.	To comply with the applicable laws or regulations and act at their request.
Co-marketing and distribution partners (Marketing Authorization Holder of the product or connected Marketing Authorization Holder) including third party auditors	As per our pharmacovigilance agreements with co-marketing and distribution partners to allow them to comply with the applicable laws or regulations and respond to their requests.
Food & Drug Administration or other competent health authorities	To comply with the applicable pharmacovigilance laws.
Third-party buyers or assignees of Lupin	To facilitate the sale and assignment of Lupin, where applicable.
Service Providers	We may disclose personal information with service providers pursuant to written agreements which require those service providers to treat such personal information in a confidential manner and to only use it for the purpose of providing the services to us. These may include but are not limited to medical service information providers and IT service providers, such as hosting and/or cloud providers.

6. How long do we retain your personal information?

Lupin will retain personal information relating to you in accordance with our customary pharmacovigilance retention periods and applicable legal reporting time periods.

Pharmacovigilance personal information will generally be kept for as long as is reasonably necessary taking into consideration our need to respond to inquiries during audits and inspections, meet our contractual obligations, comply with our legal requirements under applicable law(s), in particular by the US Food & Drug Administration regulations related to reporting of adverse events related to our products, and fulfill other purposes as outlined in this Statement.

7. Updates to this Statement

We reserve the right to update this Statement at any time, and we will provide prominent notice on our website if we update this Statement when we make any substantial updates. We may also notify you in other ways from time to time about the processing of your personal information.

8. Contact Us

If you have questions about this Statement or wish to contact us for any reason in relation to our collection, use or sharing of personal information, please contact us at:

Phone:

For Lupin Pharmaceuticals Inc, Lupin Inc. products: +1-800-399-2561
For Lupin Somerset / Novel Labs Inc. products: +1-866-403-7592

Email: dsrm@lupin.com

For other general questions or concerns, please contact our Customer Service Team at:

Phone: +1 866-587-4617
Fax: +1 866-587-4627
Email: customerservice@lupinusa.com (for US marketed products only)

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