Privacy Policy and Notice

Our Commitment to Privacy

This website www.tecfiderapregnancyregistry.com, including any and all platforms built with the intended purpose to use either in conjunction with, in addition to, or in lieu of this website (hereinafter collectively referred to as “Website”) is owned by IQVIA™ and managed on behalf of Biogen. This Website is provided to enable women who become pregnant while taking Tecfidera or were taking Tecfidera since the first day of their last menstrual period prior to becoming pregnant, to participate in the Tecfidera Pregnancy Exposure Registry study (“TecGistry”). The website enables you to take an online pre-screening questionnaire and provide personal data in order that you can be contacted by your local Registry Coordinating Center about your eligibility and possible participation in TecGistry.

This Privacy Policy describes how we use, disclose and protect any personal information that we collect or receive through this Website. For individuals participating in clinical trials as patients this Policy supplements the information you have received or will receive as part of the clinical trial’s informed consent process. The informed consent form (“ICF”) and research protocol will define how information about you will be used in connection with the clinical trial. This Policy is intended to meet applicable legal requirements globally, including in North America, Europe, Asia Pacific and other relevant jurisdictions.

Your Role and Responsibilities

• You should be familiar with how our Website works and read all our policies.
• You should be aware what information is collected on this Website, how it is stored and used.

Your Rights and Choices

• You have the right to know the information collection and storage practices of this Website.
• You have the right to know how your information will be used and by whom.
• You have the right to know to whom we may disclose your information.
• You have the right to inquire at any time as to whether we are processing personal information about you, request access to, remove, or delete or port (transfer) your personal information, and ask that we correct or amend your personal information where it is inaccurate, consistent with the requirements of the clinical trial and the ICF.

The Information We Collect

We collect personally identifiable information from you (for example, your first name, last name, title and/or email address, mailing address, language preference, contact telephone number(s) and zip or postal code that you provide to us through your use of the Website including in any of the ways explained below (“personally identifiable information”) and personal health information through direct user input as described below. If applicable, we may also receive information about how you use our Website through the automatic operation of “cookies”, web logs, and other technologies.

We will, on Biogen’s behalf, collect your full name, email address, and telephone number on the Website. We are also processing your sensitive personal data based on your pregnancy status and use of Tecfidera. Providing your email will allow an automated message to be sent to you to confirm the data you entered on the website form was received; no other emails will be sent without your consent. Your phone number is gathered by the North America Coordinating Center (the “Center”), so that it may call you to: (a) give you more information about TecGistry itself; (b) determine if you are eligible to participate in it; and (c) discuss your interest in taking part over the phone. If you meet the eligibility criteria and express an interest in taking part in it, the Center will obtain your oral consent and send you an email or mailing with a copy of the Informed Consent Form for your records, at which point you will be enrolled in TecGistry. You will also receive a copy of a Medical Release Form, which must be read carefully, signed, and returned by email or mailed to the Center as instructed. This form allows the Center to contact your Healthcare Providers to provide pertinent data about you and your pregnancy, applicable to TecGistry. During the call, you will be asked if you would like to participate in our communications program, where we send you information emails related to your MS and pregnancy, and any upcoming scheduled calls related to the study.

This policy applies to all information received through the Website, both automatically and through direct user input. For example, we receive information in any of the following ways:

1. Information as Part of the Clinical Trial Itself

When you participate in a clinical trial (or evaluate whether to participate in a clinical trial), you will be provided with information about the trial itself and how information about you will be used in connection with the trial. This “Informed Consent” form will govern how your personal information is used. This privacy policy only applies to information that is obtained through this Website beyond the information that is collected and used for the clinical trial. The ICF will be incorporated, but not merged, into this Privacy Policy. Each ICF will include, as appropriate, the scope of the study, time line and privacy information that you agree to allow the Site personnel, IQVIA, and others involved in the study process, to collect and share and to whom that information can be shared. To the extent any terms or provisions of an ICF conflict with the terms and provisions of this Privacy Policy, the terms and conditions of the ICF shall control.

2. User Input

Registration is required for use of this Website. To enable us to generate your log-in to the Website, we will collect certain personally identifiable information from you (and we may also receive information from the clinical site that will allow us to generate a user ID specific to you), once the user ID is generated you will receive an electronic message containing your individual ID and temporary password and you will need to log-in using those credentials in order to create a unique log-in password.

3. Web Logs

We use standard web logs that record basic data about people who visit our Website(s).

The following information may be contained in these logs:

• The date and time of the visit
• The pages of the Website viewed during the visit
• The IP (Internet Protocol) address of the computer used to visit the Website (computers automatically generate an IP address as they surf the internet. An IP address is a number assigned to you by your internet service provider so you can access the internet. IP addresses are also used to track new versus return visitors to the website)
• If applicable, the type of web browser used to view our Website
• The website visited immediately before coming to this Website.

We do not normally seek to identify individuals from web logs including from their IP address and we do not disclose them to others. However, web logs may be used to identify an individual who we have reason to suspect tried to damage our Website or use it in an unauthorized way. If we have reason to believe that there has been a violation of computer security or related laws, we may share our web logs with law enforcement agencies.

4. Cookies and Other Technologies

A cookie is a piece of data or a file that a website can send to your internet browser which may then store it on your computer. Cookies store information such as the pages you visited, the website features you used, and the amount of time you visited a particular webpage. They are also a means of keeping track of a user's preferences during a visit to a website. In order to provide persistence of a user’s preference, we store a unique identifier in a “temporary” or “session” cookie that only exists during the browser’s session with the website. When the user returns to the website, the identifier can be extracted from the session cookie and used to request detailed search information for that user from our database.

No cookies are used to track an identifiable individual's movement on the internet. They are only used to enhance the usability of the site.

Only to the extent applicable to your particular use of the Website, our uses of other technologies (“Technologies”) to automatically collect information through the Website fall into the following general categories:

• Operationally necessary. We may use cookies, or other similar Technologies that are necessary to the operation of our Website, services, applications, and tools. This includes Technologies that allow you access to our Website, services, applications, and tools; that are required to identify irregular site behavior, prevent fraudulent activity, and improve security; or that allow you to make use of our functions such as saved search, or similar functions.
• Performance related. We may use cookies or other similar technologies to assess the performance of our Website, applications, services, and tools, including as part of our analytic practices to help us understand how our visitors use our Website, determine if you have interacted with our messaging, determine whether you have viewed an item or link, or to improve our Website content, applications, services, or tools.
• Functionality related. We may use cookies or other similar Technologies that allow us to offer you enhanced functionality when accessing or using our Website, services, applications, or tools. This may include identifying you when you sign into our Website or keeping track of your specified preferences, interests, or past items viewed so that we may enhance the presentation of content on our Website.
• Advertising or targeting related. We may use first-party or third-party cookies to deliver content, including advertisements relevant to your interests, on our Website or on third-party sites. This includes using Technologies to understand the usefulness to you of the advertisements and content that has been delivered to you, such as whether you have clicked on an advertisement.

The following cookies may be used on our Website:

• Google Analytics cookie
• Internal session cookies for supporting Website functionality

Most browsers also allow you to block, disable and delete cookies. However, if you do that, the Website may not work properly. You always have the right to refuse the storage of cookies on your computer, or to disable and/or delete cookies at any time as your browser or device permits. It is important that you understand that if you block, disable or otherwise reject our cookies, you may not be able to use the Website or all of its interactive features or to use certain of its essential features. We suggest that you accept cookies because they allow you to get the most out of your Website experience, and to take advantage of some of the Website’s essential features.

For more information about the cookies we use, and to see what cookies have been set on your computer and how to manage, disable and delete them, visit www.allaboutcookies.org.

5. Device Information

If applicable, we may also collect certain information that your mobile device sends when you use our services or access our Website, like a device identifier, user settings and the operating system of your device. Information collected about your mobile device and internet connection may include the device's unique device identifier, IMEI number, IP address, operating system, browser type, browser language, referring/exit pages and URLs, mobile network information and the device's telephone number. Tools, applications, and widgets that we enable you to download to enable you to use the services on any mobile devices, may store information on your mobile or other devices. These tools may transmit personal information to us to enable you to access your user account and to enable us to track use of these tools. Some of these tools may enable you to email reports and other information from the tool. We may use personal or non-identifiable information transmitted to us to enhance these tools, to develop new tools, for quality improvement and as otherwise described in this Privacy Policy or in other notices we provide. We may send you e-mail messages with a “click-through URL” linked to the content of our Website. When you click onto one of these URLs, you will pass through our server before arriving at the destination webpage. We may track this click-through data to help us determine your interest in the subject matter and measure the effectiveness of our user communications. You can avoid being tracked simply by not clicking on any links or images in e-mail we send you.

The Way We Use Your Information

We acquire, hold, use, and process your personal information in order to provide, maintain and administer your login account, to provide you with information, to support your participation in the clinical trial consistent with your informed consent and based on legal grounds, your explicit consent and for the legitimate business purposes outlined in this Privacy Policy, including:

Sharing Information with Patient Guide/Study Concierge/Other Clinical Trial Health Care Providers

Where applicable at the request of the user, we forward personally identifiable information such as your name, year of birth, telephone number and/or email address and zip or postal code, and your personal health information and other information with your permission to the study concierge and/or patient guide at the medical center running the clinical trial in which you are interested or are participating. We also will share information about your participation in a clinical trial with the providers, researchers and others conducting the trial, consistent with the informed consent for the trial.

Vendors and Service Providers

We may share any information we receive with vendors and service providers in order to support your participation in the clinical trial and permit us to provide our services in connection with clinical trials. The types of service providers (processors) to whom we entrust personal information include service providers for: (i) provision of IT and related services; (ii) provision of information and services you have requested; (iii) payment processing; and (iv) customer service activities; and (v) in connection with the provision of the website. IQVIA has executed appropriate contracts with the service providers that prohibit them from using or sharing personal information except as necessary to perform the contracted services on our behalf or to comply with applicable legal requirements.

Sharing Information with Third Parties

It is possible that we may need to disclose personally identifiable information about you in response to a law enforcement or national security request or legal process such as a search warrant, subpoena, or court order or in connection with an investigation or prosecution of suspected or actual illegal activity. Disclosures may also be made to comply with the law, protect our legal rights, or yours, or those of others’ including also property, or safety, to protect the security or integrity of our Website, to take precautions against liability, or during emergencies if physical safety is believed to be at risk., or if we, in good faith, believe that disclosure is otherwise necessary or advisable. These types of disclosures are unlikely, but they are possible and so we describe them here.

If applicable, we also may need to share information with regulators or others in government who oversee clinical trial activities, as described in the ICF and with the Sponsor of the study, Biogen.

In addition, from time to time, server logs may be reviewed for security purposes – e.g., to detect unauthorized activity on the services. In such cases, server log data containing IP addresses may be shared with law enforcement bodies in order that they may identify users in connection with their investigation of the unauthorized activities.

Use for Our Administrative Purposes

We also may use your information for our administrative purposes, such as to measure interest in and/or develop our Website services, ensure internal quality control, comply with regulatory requirements, including prevent potentially prohibited or illegal activities, and enforce our Terms and Conditions.

Aggregate Data Use

We combine and use non-personal information (aggregated data) e.g. from our web logs and other Technologies to study how the Website is being used. We will periodically analyze this aggregated data and use what we learn to make improvements to our website. In addition, we may share this aggregated data (which does not contain any information which can identify an individual) with our clinical research partners to assist them in better designing their websites or clinical trials.

Access, Correction, Deletion, and Removal of Personal Information

In some situations, you may access, update, correct or remove the personal information you provided to us by sending an email to tecgistry@quintiles.com. Your ability to correct, remove or delete your personal information will depend in most situations on the informed consent agreement and the clinical trial protocol, which may require that information be maintained.

Non-identifiable information in our aggregate database will not be deleted. Like all responsible Websites, we maintain backup files as a protection against natural disasters, equipment failures, or other disruptions. Backup files protect you and us because they lessen the risk of loss of valuable data. Removing a record from our principal files does not remove that record from any of the backup systems. It may take up to 6 months before all information in a backup record is completely erased through the normal recycling of backup files. In the meantime, as long as backup records exist, they receive the same privacy and security protections as our other records.

You can ask us to provide you with information about and copies of your personal information that we keep by sending an email to tecgistry@quintiles.com. You may also use this contact point for any other questions you may have about your rights in connection with your personal information, including the ability to request that we remove, delete or port (transfer) your personal information, and or to ask that we correct or amend any inaccurate information. Please note that these rights are not automatic or absolute and may be subject to a fee, to the extent allowed by law and consistent with the ICF.

If you have any requests concerning your personal information or have any questions or comments about privacy, please send an email to tecgistry@quintiles.com. Please include your contact information, the name of this website or service at issue, and a detailed description of your request or privacy concern.

PLEASE NOTE: Although we make good faith efforts to provide users with access to their personal information, there may be circumstances in which we are unable to provide access or delete certain information, including but not limited to where the information: contains legally privileged information, must be maintained according to law, would compromise the integrity of the clinical study or the study data, would compromise others’ privacy or other legitimate rights, where the burden or expense of providing access would be disproportionate to the risks to the individual’s privacy in the case in question, where it is commercially proprietary or where the information must be maintained in connection with the clinical trial. If we determine that access should be restricted in any particular instance, we will provide you with an explanation of why that determination has been made and a contact point for any further inquiries. To protect your privacy, we will take commercially reasonable steps to verify your identity before granting access to or making any changes to your personal information. All requests received from you under this Privacy Policy will be processed in line with applicable local laws.

Your Choices

• You can always choose not to provide information, however, if you choose not to provide information, you will not be able to use any of the services that require you to log-in and you may be unable to participate in the relevant clinical trial.
• Where you have consented to our processing of your personal information, you may withdraw that consent at any time and opt out of further processing by following the instructions in this Privacy Policy. This will not have an impact on information that has been collected, used or disclosed previously. Even if you opt out, we may still collect and use non-personal information regarding your activities on our website.
  IMPORTANT NOTE: If you desire to correct, amend or delete personal information that was provided to us by third parties (and not directly by you), you may contact us to access, correct or remove your information from our files. However, we also recommend that you contact the third-party website operators to whom you have provided such information under such third parties' privacy policies, as we do not control and are not responsible for those practices or privacy policies.
• You have the right to ask us not to process your personal information for any marketing-related purposes. We will inform you (before collecting your personal information) if we intend to use your information for such purposes or if we intend to disclose your information to any third party for such purposes. You can also exercise your right to object to such use at any time by sending an email to tecgistry@quintiles.com.
• If you receive automated email messages or other emails that you prefer not to receive, please send an email to tecgistry@quintiles.com for further assistance. Alternatively, if you receive an unwanted email from us, you can use the unsubscribe link found at the bottom of the email to opt out of receiving future emails. We will process your request within a reasonable time after receipt. Note that you will continue to receive transaction-related emails regarding services you have requested. We may also send you certain communications regarding our services and you will not be able to opt out of those communications (e.g., communications regarding updates to our Terms of Use or this Privacy Policy).
• We maintain “do-not-call” and “do-not-mail” lists as mandated by law. We process requests to be placed on do-not-mail, do-not-phone and do-not-contact lists within 60 days after receipt, or such shorter time as may be required by law.

Do Not Track

Do Not Track (“DNT”) is a privacy preference that users can set in certain web browsers. DNT is a way for users to inform websites and services that they do not want certain information about their webpage visits collected over time and across websites or online services. Please note that we do not respond to or honor DNT signals or similar mechanisms transmitted by web browsers.

International Transfers

This Website and its services are provided from the United States of America. Accordingly, any personal information we receive through direct user input will be stored on our servers located in the United States of America. By choosing to visit the Website, utilize the services, or otherwise provide information to us, you agree and consent to this storage in the US-located servers and that personal information you provide may also be transferred to and processed by persons operating outside the US and/or the European Economic Area who work for us and/or service vendors who are engaged to help provide the services. You should be aware that not all countries offer the same standards of data protection and personal information privacy as those that may apply where you reside. However, your personal information will always be treated and used by us in accordance with this Website Privacy Policy.

Information Security

Processing personal information in a secure manner is essential to our business and for your protection as a user. Maintaining a secure network and server system is in the best interests of our users and our research partners. We process and store personally identifiable information using industry standard physical, technical, and administrative safeguards to secure such personal information against foreseeable risks such as unauthorized use, access, disclosure, destruction, and modification. Such security safeguards include use of encryption, password protection and user authenticated access rights. While we will use reasonable efforts to create a secure, safe and reliable website, the confidentiality of any communication or material transmitted to or from the website over the internet cannot be guaranteed.

The security of your personal information is also, in part, your responsibility. When you register through the Website, you should select passwords that are hard to guess, and you must keep your passwords private and confidential. You should not share your password with anyone and should not store it in an unprotected format, such as taped to your computer or saved in your email. We do not accept liability for unintentional disclosure.

By using the Website or providing personal information to us, you agree that we may communicate with you electronically regarding security, privacy, and administrative issues relating to your use of the website. If we learn of a security system’s breach, we may attempt to notify you electronically by posting a notice on the website or sending an e-mail to you. You may have a legal right to receive this notice in writing.

Children's Privacy

Protecting the privacy of the very young is especially important. This Website is not intended for or designed to attract minors. Users under the age of 18 or the age of legal majority in their country should not submit information to our Website, and we do not collect, receive or knowingly keep information from any user we know or have reason to believe is a child under the age of 18 or age of legal majority, unless the information is provided by a parent or guardian. If a child has provided us with personally identifiable information, the parent or guardian of that child should contact us if they want this information deleted from our files.

Users that are participating in pediatric trials will be asked to enter a date of birth. If the date of birth is under the age of 18 or legal majority in their country, the user will not be allowed to continue and submit the information unless that information is submitted by a parent or guardian.

Data Retention

The information you provide to us may be archived or stored periodically by us according to backup processes and will only be retained for as long as is required for the purposes for which it was collected, to provide our products and services to you, to support your participation in clinical trial activity, resolve disputes, establish legal defenses, conduct audits, pursue legitimate business purposes, enforce our agreements, and comply with applicable laws. Personal information collected as part of TecGistry will be retained for the duration of the registry.

Accountability/Compliance and How to Contact Us

We are committed to protecting the privacy of our Website users. We have posted this Privacy Policy to communicate the specifics of this commitment.

If you wish to access, correct, update or request removal of any of your information you provided to us or if you have any questions regarding this Privacy Policy or would like more information on our privacy practices, please contact us at: tecgistry@quintiles.com. We will address your concerns and attempt to resolve any privacy issues in a timely manner.

In addition, we will address any complaints or questions that our users may have regarding this policy or its implementation. If you have a complaint or question about our Privacy Policy, please email to tecgistry@quintiles.com. We will respond to your comments or concerns as soon as possible following receipt of your inquiry.

If any request remains unresolved, you may contact: IQVIA’s Privacy Office at PrivacyOfficer@iqvia.com.

If you are a resident of the European Union or Switzerland and feel that any request or complaint remains unresolved, you may contact your national data protection authority for your EU Member State which can be located through the following European Commission website: https://ec.europa.eu/info/law/law-topic/data-protection/reform/what-are-data-protection-authorities-dpas_en.

For queries by post to IQVIA, please write to:

83 Wooster Heights Road, Danbury, CT 06810, USA

or

4820 Emperor Boulevard, Durham, North Carolina 27703, USA

As this Privacy Policy explains, we are responsible for determining the purposes and means for the handling and processing of personal information subject to this Privacy Policy. Biogen, Inc. is the “controller” of your personal information collected through this website for purposes of compliance with the Data Protection Law of the European Union. Biogen has assigned a data protection officer responsible for overseeing Biogen’s compliance with EU data protection law, which you may contact at privacy@biogen.com; or c/o the Chief Privacy Officer, of 225 Binney Street, Cambridge, MA 02142, USA in case of any questions or concerns regarding the processing of your personal data. If Biogen’s processing of your personal data is covered by EU law, you may also lodge a complaint with the corresponding data protection supervisory authority in your country of residence. You can find the relevant supervisory authority name and contact details under http://ec.europa.eu/justice/data-protection/bodies/authorities/index_en.htm.

Links to Other Websites

Our Website may contain links to other third-party websites. You should carefully review the privacy policies or notices and practices of other websites, as we cannot control or be responsible for their privacy policies, notices or practices. For links to other company web properties, please review those privacy terms as well as they may differ from those on this Website.

Notification of Changes

As we provide more information and services on our Website and as privacy laws and regulations change, we may need to revise or update our Privacy Policy from time to time. We will always change the “Last Updated” date on the Privacy Policy to reflect when it was last revised. If we make a meaningful change to the Privacy Policy, we will notify you here, by email or by means of a notice on the Website home page. However, we will always continue to protect your personal information according to the law and as described by our current Privacy Policy.

Additionally, before we use personal information for any new purpose not originally authorized by you, we will endeavor to provide information regarding the new purpose and give you the opportunity to opt out. Where your consent for the processing of personal information is otherwise required by law or contract, we will endeavor to comply with the law or contract.

This Privacy Policy was last updated on 26 August 2019.