Scope

This certification applies to Amneal Pharmaceuticals LLC and its U.S. subsidiaries, including Impax Laboratories, LLC and Amneal Pharmaceuticals of New York, LLC (collectively referred to herein as “Amneal”). This Privacy Shield Policy sets forth the privacy principles that Amneal follows in connection with the transfer of personal information from European Economic Area (“EEA”) member countries and Switzerland to the United States.

Amneal has certified to the U.S. Department of Commerce that it complies with the EU-U.S. Privacy Shield Framework and the Swiss-U.S. Privacy Shield Framework and the Privacy Shield Principles of Notice, Choice, Accountability for Onward Transfer, Access, Security, Data Integrity and Purpose Limitation, and Recourse, Enforcement and Liability (collectively, the “Privacy Shield”). If there is any conflict between this Privacy Shield Policy and data subject rights under the Privacy Shield Principles, the Privacy Shield Principles shall govern. To learn more about the Privacy Shield program and to view our certification page, please visit https://www.privacyshield.gov/.

With respect to personal data received or transferred pursuant to the Privacy Shield, Amneal is subject to the regulatory and enforcement powers of the U.S. Federal Trade Commission (the “FTC”).

 

Data Collected

Amneal may collect personal information from or concerning individuals in the EEA and Switzerland from sources such as: (1) clinical research subjects; (2) medical and healthcare professionals, including clinical investigators and staff conducting clinical or medical research; (3) potential or actual clinical trial and post-market patients and their family members/caregivers; (4) adverse event reports; (5) investors and stockholders; (6) employees; (7) customers; (8) vendors, suppliers, contractors, and business partners; and (9) government officials or agencies.

 

Purpose of Data Collection

The purposes for collecting data vary but may include: (1) carrying out scientific or medical research; (2) adverse event and product complaint reporting, managing and overseeing vendors/consultants; and (3) communicating about Amneal’s current or future drug candidates, approved therapies, if any, and services.  Amneal also processes human resources data for various purposes, including without limitation: recruitment; compensation, benefits administration and payroll; performance appraisals and training; protection against injury, theft, legal liability, fraud and abuse; and other business purposes.

For additional information about the types of data Amneal collects, please refer to the Privacy Policy linked here.

 

Privacy Shield Principles

1. Notice

Amneal will not sell or provide your personal information to any third party without notice.  When Amneal directly collects personal information from EEA and/or Swiss individuals, it will notify you of the purposes for which the information is collected and used, your ability to limit the use and disclosure of such information, and how to contact Amneal.  Amneal will provide this notice in clear and conspicuous language, either through this Privacy Shield Policy or other means, such as informed consent forms, statements on Amneal’s website and other disclosures.

2. Choice

Subject to the exceptions outlined in the “Product Safety and Efficacy Monitoring” section below, and as otherwise permitted by applicable law, Amneal does not use or intend to use your personal information for any purpose (other than that for which it was originally collected) without your consent.

Amneal does not disclose personal information to third parties for purposes that are incompatible with the purposes for which it was originally collected.  Amneal may occasionally transfer personal information to third parties who act for or on behalf of Amneal, or in connection with the business of Amneal, for further processing consistent with purposes for which the data were originally collected.  Where disclosure of personal information to a third party is likely or necessary, further notice may be provided, where appropriate, at such collection points as to the intended use of the data.

Amneal requires that such third parties protect the information and, where appropriate, Amneal will contractually require such parties to process data transferred only for the purposes expressly authorized by Amneal.

Amneal will provide an individual opt-out choice, or opt-in for sensitive data, before it shares your data with third parties (other than Amneal’s agents) or before Amneal uses such data for a purpose other than which it was originally collected or subsequently authorized.  To request to limit the use and disclosure of your personal information, please submit a written request to the contact information listed below in the “Enforcement & Dispute Resolution” section.

3. Accountability for Onward Transfers

Amneal will not transfer personal information from or concerning individuals in the EEA and Switzerland to third parties unless such third parties have entered into a written agreement with Amneal requiring that the third party provide at least the same level of privacy protection as is required by the relevant principles of the Privacy Shield.  Amneal will only transfer data to its agents, resellers or third-party service providers who need the information in order to provide services or to perform activities on behalf of Amneal.  The third parties that now or in the future may receive personal information provide services to or on behalf of Amneal, including without limitation: clinical research, direct marketing assistance, distributors/resellers, data storage, hosting services, and sales support.  Amneal does not share data with third parties who are not providing services to or on behalf of Amneal.

In certain situations, we may be required to disclose personal data in response to legal or regulatory requests by government authorities or agencies, including to meet national security or law enforcement requirements.

In cases of damages resulting from onward transfers to third parties of data of EEA and/or Swiss individuals transferred pursuant to the Privacy Shield, Amneal is potentially liable, unless Amneal proves that it is not responsible for the event giving rise to the damage.  Amneal may provide personal data from clinical trials conducted in the EEA and Switzerland to regulators in the United States and other countries for regulatory and supervision purposes.

4. Access

Pursuant to the Privacy Shield, Amneal will provide individuals in the EEA and Switzerland with reasonable access to the personal information it maintains about them upon such individual’s written request, and Amneal will take reasonable measures to allow for the correction, amendment, or deletion of information that is shown to be incorrect or inaccurate.  You may contact Amneal using the contact information below in the “Enforcement & Dispute” resolution section to learn whether or not Amneal has your personal data subject to this Privacy Shield Policy, and to request corrections, amendments or deletion of such data.  This right applies only to personal information about you and is subject to other limitations as defined by applicable law, rule or regulation, as well as whether the burden or expense of providing access would be disproportionate to the risks related to the privacy of the individual or where the rights of other individuals would be violated.  To confirm that we are providing you with access to your own data and not someone else’s, you will need to provide sufficient identifying information. Any identifying information you share will be subject to Amneal’s Privacy Policy available here.

5. Product Safety and Efficacy Monitoring

The Notice, Choice, Onward Transfer and Access Principles outlined above do not apply to Amneal’s product safety and efficacy monitoring activities, including the reporting of adverse events and the tracking of patients or subjects using certain medicines or medical devices to the extent that the adherence to these principles interferes with compliance with regulatory requirements, including disclosures to agencies, such as the U.S. Food and Drug Administration.

6. Security

To protect personal information from or concerning individuals in the EEA and Switzerland, Amneal has in place reasonable and appropriate technical and operational security measures to prevent unauthorized access, loss, misuse, unauthorized access, disclosure, alteration and destruction of data in its control.

7. Data Integrity and Purpose Limitation

The personal information Amneal uses or processes will be necessary for and related to the purpose for which it was obtained or collected.  Amneal will not use or process the data in a manner that is incompatible with the reason it was collected or authorized to be used.  Amneal will take reasonable measures to ensure that the data is accurate, complete, current, and reliable for its intended use.

8. ENFORCEMENT & DISPUTE RESOLUTION

The FTC has jurisdiction over Amneal’s compliance with the Privacy Shield.

In compliance with the Privacy Shield Principles, Amneal commits to resolve complaints about your privacy and Amneal’s collection or use of your personal information transferred to the United States pursuant to the Privacy Shield.  EEA and Swiss individuals with Privacy Shield inquiries or complaints should first contact Amneal at dpo@amneal.com or in writing at:

Amneal Pharmaceuticals LLC
Attn: Legal Department
400 Crossing Boulevard, 3rd Floor
Bridgewater, NJ 08807 USA

Amneal has further committed to refer unresolved privacy complaints under the Privacy Shield Principles to an independent dispute resolution mechanism through the ICDR/AAA.  If you do not receive timely acknowledgment of your complaint, or if your complaint is not satisfactorily addressed, please visit http://go.adr.org/privacyshield.html for more information and to file a complaint.  This service is provided free of charge to EEA and Swiss individuals.

If your complaint involves human resources data transferred to the United States from the EU and/or Switzerland in the context of the employment relationship, and Amneal does not address it satisfactorily, Amneal commits to cooperate with the panel established by the EU data protection authorities (the “DPA Panel”) and/or the Swiss Federal Data Protection and Information Commissioner, as applicable, and to comply with the advice given by the DPA Panel and/or Commissioner, as applicable with regard to such human resources data.  To pursue an unresolved human resources complaint, you should contact the state or national data protection or labor authority in the appropriate jurisdiction.  Contact details for the EU data protection authorities can be found at http://ec.europa.eu/justice/data-protection/bodies/authorities/index_en.htm.  Complaints related to human resources data should not be addressed to the ICDR/AAA.

If your Privacy Shield complaint cannot be resolved through the above channels, under certain conditions, you may invoke binding arbitration for some residual claims not resolved by other redress mechanisms.  Please see Privacy Shield Annex 1 at https://www.privacyshield.gov/article?id=ANNEX-I-introduction.

 

Changes to this Privacy Shield Policy

Amneal may amend or change this Privacy Shield Policy at any time and from time to time without prior notice consistent with the requirements of the Privacy Shield and applicable data protection and privacy laws and principles.  If and when Amneal amends or changes this Privacy Shield Policy, Amneal will post the changes on this page of its website to notify you of the changes.

 

Effective November 22, 2019