INTRODUCTION

Pharm-Olam International, Ltd. is the U.S.–based parent company of companies in many locations around the world, including without limitation the European Union.  Pharm-Olam International, Ltd. and each affiliate and subsidiary thereof (collectively referred to as Pharm-Olam) will conduct every business transaction (including without limitation, operations, negotiations, and marketing) with integrity and will comply with the laws and regulations of the United States, as well as the laws and regulations of each foreign country in which Pharm-Olam operates or is looking to operate.  All Pharm-Olam personnel are expected to conduct Pharm-Olam business legally and ethically.

At Pharm-Olam the foundation of our business is information related to the provision of clinical trials management or related services for the pharmaceutical and bio-tech industry corresponding to human clinical research studies.  Given the nature of our work, the protection of personal data is critical for our company and our customers. For these reasons, Pharm-Olam has a comprehensive, global privacy program designed to respect and protect data privacy rights. Pharm-Olam intends that its corporate privacy policy and standard practices and procedures will ensure timely compliance with all applicable international laws and regulations, including but not limited to, for example, the European Union's Data Protection Directive (95/46/EEC) (EUDP), the UK Data Protection Act, the U.S.-EU Safe Harbor Framework and the U.S-Swiss Safe Harbor Framework.

We self-certify compliance with

This Privacy Policy Statement sets forth the privacy principles that Pharm-Olam follows with respect to transfers of personal information.

Accordingly, Pharm-Olam intends that all transfers of personal information comply with all applicable international laws and regulations.  Specifically for example, for transfers of personal information from Switzerland and the EU to the US, Pharm-Olam follows and complies with the U.S.-EU and the U.S.-Swiss Safe Harbor Principles published by the U.S. Department of Commerce regarding the collection, use, and retention of such information (the “US Safe Harbor Principles”).  Pharm-Olam has certified that it adheres to the US Safe Harbor Privacy Principles of notice, choice, onward transfer, security, data integrity, access, and enforcement.  To learn more about the Safe Harbor program, and to view Pharm-Olam’s certification, please visit http://www.export.gov/safeharbor/.  If there is any conflict between the policies in this privacy policy and the US Safe Harbor Principles, the US Safe Harbor Principles shall govern.

Additionally, Pharm-Olam follows the UK Data Protection Principles published by the U.K. Information Commissioner (the “UK Data Protection Principles”) with respect to all transfers of personal information within the UK and from the UK to the US.  If there is any conflict between the policies in this privacy policy and the UK Data Protection Principles, the UK Data Protection Principles shall govern.  Transfers of personal information outside of the European Union, other than to the U.S., should be made in accordance with the data protection principals prescribed by the international law and regulations applicable in the relevant countries.

The US Safe Harbor Principles, the UK Data Protection Principles, and the data protection principles of any other relevant country or jurisdiction are collectively referred to as the “Principles” in this policy.

This privacy policy outlines Pharm-Olam’s general policy and practices for implementing and adhering to the Principles, including the types of information gathered, how it is used, related security and retention measures, potential recipients of such information, and the notice and choice, affected individuals have regarding use of and ability to correct that information.
       
Pharm-Olam values the confidence of its customers, and vendors, and respects individual privacy, including personal information of employees, consumers, healthcare professionals, medical research subjects, clinical investigators, customers, business partners, consultants, contractors, subcontractors, and investors.  Not only does Pharm-Olam strive to collect, use and disclose personal information in a manner consistent with the laws of the countries in which it does business, but it also has a tradition of upholding the highest ethical standards in its business practices.

To ensure implementation and enforcement of this policy, Pharm-Olam set up a task force, the members of which represent a cross-section of different departments and geographical areas. Paula Francis will serve as the Chief Privacy Officer and will lead the task force.

SCOPE:

Pharm-Olam intends that this policy apply to all transfers of personal information, whether in electronic, paper or verbal format, received or made by Pharm-Olam.  The provisions of this policy apply to all officers, directors, employees, stockholders, contractors, subcontractors, agents and consultants of Pharm-Olam.

DEFINITIONS:
For purposes of this policy, the following definitions shall apply:
"Agent" means any third party that uses personal information provided to it by or on behalf of Pharm-Olam to perform tasks on behalf of and under the instructions of Pharm-Olam.
"Pharm-Olam" means Pharm-Olam International, Ltd., together with its successors, affiliates, subsidiaries, divisions and groups in the United States and other countries worldwide.
"Personal Information" means any individual’s information or set of information that Pharm-Olam has or may have in the future that identifies or could be used by or on behalf of Pharm-Olam to identify an individual. Personal information does not include information that is encoded or anonymized or publicly available information that has not been combined with non-public personal information.
"Sensitive Personal Information" means personal information that reveals race, ethnic origin, political opinions, religious or philosophical beliefs, criminal records or trade union membership, or that concerns health or sex life.  In addition, Pharm-Olam will treat as sensitive personal information any information received from a third party where that third party treats and identifies the information as sensitive.

PRIVACY PRINCIPLES:
Pharm-Olam intends that transfers of personal information are received or made by Pharm-Olam in accordance with the data protection privacy principals of any and all applicable international laws and regulations, including but not limited to the US Safe Harbor Privacy Principles and the UK Data Protection Principles. 
The Safe Harbor Privacy Principles and the UK Data Protection Principles are set forth below: 

Notice
Where Pharm-Olam collects personal information directly from individuals in the European Union and Switzerland, it will inform them about the types of information gathered, the purposes for which it collects and uses personal information about them, the types of non-agent third parties to which Pharm-Olam discloses that information, and the choices and means Pharm-Olam offers individuals for limiting the use and disclosure of their personal information.  Notice will be provided in clear and conspicuous language when individuals are first asked to provide personal information to Pharm-Olam, or as soon as practicable thereafter, and in any event before Pharm-Olam uses or discloses the information for a purpose other than for which it was originally collected.
Where Pharm-Olam receives personal information from its subsidiaries, affiliates or other entities in the EU and Switzerland, it will use such information in accordance with the notices provided by such entities and the choices made by the individuals to whom such personal information relates.

Choice

Pharm-Olam will offer individuals the opportunity to choose (opt-out) whether their personal information is: (1) to be disclosed to a third party; or (2) to be used for a purpose other than the purpose for which it was originally collected or subsequently authorized by the individual.  For sensitive personal information, Pharm-Olam will give individuals the opportunity to affirmatively or explicitly (opt in) consent to the disclosure of the information to a third party or use for a purpose other than the purpose for which it was originally collected or subsequently authorized by the individual.  Pharm-Olam shall treat sensitive personal information received from an individual the same as the individual would treat and identify it as sensitive personal information.

Pharm-Olam will obtain consent from all customers, employees, healthcare professionals, medical research subjects, clinical investigators, customers, business partners, contractors, subcontractors, consultants and investors, where required, for processing, use and/or distribution of any personal and/or sensitive personal information prior to the processing, use or distribution of such information.

Data Integrity

Pharm –Olam will use personal information only in ways that are compatible with the purposes for which it was collected or authorized by the individual.  To the extent necessary for those purposes, Pharm-Olam will take reasonable steps to ensure that personal information is relevant to its intended use, accurate, complete, and current.

Onward Transfers

Pharm-Olam may share an individual's information with agents, contractors or partners of Pharm-Olam in connection with services that these individuals or entities perform for, or with, Pharm-Olam.  Pharm-Olam will obtain assurances that these agents, contractors or partners subscribe to the Principles, will safeguard all data in line with this policy, and will agree in writing to provide an adequate level of privacy protection in compliance with this policy.

Data Security

Pharm-Olam will ensure reasonable safeguards are in place to protect personal information in its possession from loss, misuse and unauthorized access, disclosure, alteration and destruction. Pharm-Olam has put in place appropriate physical, electronic and managerial procedures to safeguard and secure the personal information from loss, misuse and unauthorized access, disclosure, alteration and destruction.  Specifically, for personal information subject to electronic storage or transmission, Pharm-Olam maintains a private, secure global network that is protected from malicious computer virus infections and is monitored for unauthorized access.  Both electronic and paper based records holding personal information are maintained in access controlled facilities for which business continuity plans are required.

Access

Pharm-Olam shall allow an individual access to their personal information and allow the individual to correct, amend, or delete inaccurate information, except where the burden or expense of providing access would be disproportionate to the risks to the privacy of the individual in the case in question or where the rights of persons other than the individual would be violated.  Due to regulatory, statistical, and contractual requirements, we are not able to grant direct access to research data to research participants or clinical investigators.

Enforcement

Pharm-Olam uses a self-assessment approach to ensure compliance with this privacy policy and periodically verifies that the policy is accurate, comprehensive for the information intended to be covered, prominently displayed, completely implemented and accessible and in conformity with the Principles.  We encourage interested persons to raise any concerns using the contact information provided and we will investigate and attempt to resolve any complaints and disputes regarding use and disclosure of personal information in accordance with the Principles.

If a complaint or dispute cannot be resolved through our internal process, we agree to cooperate and comply with the EU data protection authorities and the Federal Data Protection and Information Commissioner of Switzerland.

Pharm-Olam’s Chief Privacy Officer and Privacy Policy task force will ensure enforcement of this policy.

Any employee that Pharm-Olam determines to be in violation of this policy will be subject to disciplinary action and this may result in termination of their employment with Pharm-Olam.

Any complaints or disputes with regards to this policy should be directed via e-mail to the Pharm-Olam Chief Privacy Officer at ChiefPrivacyOfficer@pharm-olam.com.

Amendments

Pharm-Olam reserves the right to amend this policy from time to time to ensure it remains consistent with the Principles.

Reservation of Rights

Pharm-Olam reserves the right to share individuals’ personal information as required by law or duly authorized information request of governmental authorities.

Information Subject to Other Policies

Pharm-Olam is committed to following the Principles for all personal information within the scope of the Principles.  However, certain information is subject to Pharm-Olam policies that may differ in some respects from the general policies set forth in this privacy policy.