Arbor Pharmaceuticals, LLC Internet Privacy Policy

This site is owned by Arbor Pharmaceuticals, LLC. This Privacy Policy is designed to tell you about our practices regarding collection, use, and disclosure of information that you may provide via this site. Please be sure to read this entire Privacy Policy before using or submitting information to this site. This site is intended for use by residents of the United States only.

Arbor Pharmaceuticals, LLC appreciates the privacy considerations applicable to visits to one of our websites. Because your privacy is important to us, we provide this notice about the collection and use of information. By using one of our websites, you accept the practices described in this Privacy Notice.

Our privacy policy may change in significant ways, and we will make reasonable efforts to keep our written policy up to date. In the event that we revise our privacy policy, we will post the revised policy or the changes on our websites and/or may otherwise give notice as required by law.

When we refer to ourselves as "we" or "Arbor," we mean our entire company, including any company that we control (for example, a subsidiary that we own). We may share information among companies that we own or control, and we may share information with our co-promotion partners and companies working with Arbor, but all information we share will always be protected under the terms of this Privacy Policy. In the event that you follow a link to a website that is for a company or person that is not under our control, you are reminded to read the privacy policy at each. Arbor is not responsible for how other websites treat your privacy once you leave an Arbor website.

Visitor Information. Website visitors can access the website's home page, and browse some areas of the site, without disclosing any personally identifiable information. We reserve the right to track information provided to us by your browser, which may include the website you came from, the type of browser you use to view the site, the time and date of access, and other information that does not personally identify you. On some of our sites, we may require you to register to access portions of the site. If we do require you to register, Arbor may use certain methods to validate your identity as a user so that appropriate site access rights can be enacted for you, which methods may include the use of usernames and passwords. You are responsible for maintaining the privacy of your password.

Generally, information is gathered about each visitor that is automatically collected by our web server, such as the visitor's IP address and domain name, which can then be used by Arbor to, among other things, individually customize its offerings and presentations for a visitor. Additionally, we use "cookies", small files sent to your web browser and stored on your computer's hard drive, to improve the website experience, personalize websites, and track usage of and across websites. Such cookies also are used to speed-up access to the website and the particular information you want to see. Cookies do not contain any personal information, and you may use your web browser settings to prevent the use of cookies, although you should be aware that some functionality may be lost if you do so.

Registered User Information. For those websites where registration or membership is required to obtain access, visitors are requested to provide identifying information, such as name, gender, contact information, and other identifying information, in order to obtain access. We use such websites in order that we may, among other things, better communicate our healthcare information to you and personalize your experience at our websites. In such cases, your view of the website may change to reflect the information that you share with us or that we have otherwise obtained about you.

Information needed by us will be clearly identified to you and must be accurately and timely provided by you. In the event that the information that you are required to provide changes, please update your user account with us and notify us of the change. Failing to provide and maintain the accuracy and completeness of our records regarding such information is prohibited.

Online Communications/Transactions. We reserve the right to collect information that you voluntarily provide to us through responses to the "contact us" page and any surveys, search functions, questionnaires, feedback and the like that might be placed on the website by us. On some of our websites, we may offer health assessment tools that ask you to provide self-assessment information. We may also ask you to provide additional information such as your e-mail address if you want to obtain additional services or information or to resolve complaints or concerns. We typically use the information that you provide to help us better understand our customers and their interests, develop and improve our products, and communicate information about our products and services to you.

For those websites, if any, where we may allow physicians or other healthcare professionals (the "Customers") to order our products online, we require that certain Customer information be provided to us and may collect or otherwise obtain additional information about Customers. Additionally in such instances, we may interact with other sources in order to verify identity and validate licensure status. In some cases, we may also ask Customers for specific financial processing information, such as credit card information, so that we may process online a transaction. In such cases it may be necessary for us to contact third party financial or credit organizations to confirm such Customer's credit card information for the order.

Marketing/Promotion. From time to time, we may augment our existing user databases with legally obtained information from third parties. Some of this information may be personally identifiable. We do this to better target our information offerings and promotional campaigns and to provide pertinent offers in which we think you would be interested. At times, we also may seek to contact you using the information that you have provided or we have legally obtained in order to make you aware of certain developments and share information. In doing so, we may send information to you that we believe will benefit you, including information about the products of Arbor and our affiliates. In such instances where we contact you, we will provide you with an opportunity to tell us that you do not want to receive such promotional and/or information, and should you elect not to receive promotional or informational material from us and properly notify us of such election, we will remove you as a recipient consistent with your request.

Other Uses of Collected Data. Aside from the uses already described, we also use the information gathered from or about visitors for market analysis and product development. Please be aware that we may provide such information, typically in an aggregate form with identifying information removed, to third parties. When aggregate health information is provided, we pool it from many individual records and strip it of any data that could be used to identify an individual before it is used. We require any third party that receives aggregated healthcare data from us to agree not to attempt to re-identify the people it belongs to. YOU SHOULD BE AWARE THAT WE ALSO RESERVE THE RIGHT TO DISCLOSE INFORMATION ABOUT YOU WHEN WE BELIEVE THAT WE ARE REQUIRED TO DO SO BY LAW.

General policies. We have implemented certain commercially reasonable technologies and/or security practices, policies, rules, and other measures to protect personal data that we have under our control from unauthorized access, improper use, alteration, unlawful or accidental destruction, and accidental loss. We also seek to protect certain information by requiring that employees and others who have access to or are associated with the processing of personal data respect its confidentiality. In the event we sell the company, a division or unit of it, or a product line, we typically require the purchaser to honor the obligations of confidentiality generally expressed per this Privacy Policy.

Storage of health information. Personally identifiable health information you share with us is required to be stored by us, we will do so using our database servers at data centers that are hosted by us or third-parties who have entered into agreements with us that require them to observe our confidentiality requirements. Data centers are designed to be physically secure and protected from unauthorized access by unauthorized persons. When necessary to do so, we may release personal health information if, in our judgment and/or after review by an attorney, the release is compelled by law or regulation or is necessary to prevent the death or serious injury of an individual.

Third parties. Please be aware that at times third parties may be working on our behalf that require limited access to some of the personal information we maintain about our users. Other companies may collect information on our behalf through their sites. This occasionally incorporates the use of frames on the site that will mask the URL you are visiting in the browser address window. We typically require such companies to comply with the terms of our privacy policies, to limit their access to any personal information to the minimum necessary to perform their obligations, and not to use the information they may access for purposes other than fulfilling their responsibilities to us. We also try to limit such other companies from using personally identifiable healthcare information.

Updating Your Information and Contacting Us. You can always contact us in order to (i) remove the personal information that you have provided to us from our systems, (ii) update the personal information that you have provided to us, and (iii) change your preferences with respect to marketing contacts by e-mailing us at: Gliadel@arborpharma.com or if available, also logging into your account to update your information.

Please contact us with your questions about this privacy statement or about Arbor's handling of your information at: compliance@arborpharma.com

Copyright © 2014 Arbor Pharmaceuticals, LLC

Gliadel® is manufactured by Eisai Inc. for Arbor Pharmaceuticals, LLC.

Gliadel® is a registered trademark of Eisai Inc.

INDICATIONS

GLIADEL Wafer (carmustine implant) is indicated for the treatment of patients with newly-diagnosed high-grade glioma as an adjunct to surgery and radiation.

GLIADEL Wafer is also indicated in patients with recurrent glioblastoma as an adjunct to surgery.

IMPORTANT SAFETY INFORMATION

You should not be given GLIADEL Wafer if you are allergic to carmustine or any of the components of GLIADEL Wafer.

If you are undergoing surgery and implantation of GLIADEL Wafer, you should be monitored closely for known complications, including convulsions, infections, abnormal wound healing, and swelling of the brain.

If you are pregnant or are planning to become pregnant, you should understand that carmustine, the active component of GLIADEL Wafer, can cause harm to the fetus if given to a pregnant woman. It is not known if either carmustine, or other components of GLIADEL Wafer are excreted in human milk. Many drugs are excreted in human milk and there is a risk for serious side effects from carmustine in nursing infants; therefore discontinuation of nursing is recommended if you will be receiving GLIADEL Wafer.

It is possible that if GLIADEL Wafers are not implanted properly, they could block the flow of cerebrospinal fluid and might cause abnormal accumulation of fluid in the brain (obstructive hydrocephalus).

The short-term and long-term safety of GLIADEL Wafer when given together with chemotherapy is not fully known.

Following surgery to remove a brain tumor and implantation of GLIADEL Wafer, the following side effects have been reported in clinical studies:

Seizures (convulsions): In clinical studies, seizures have occurred within days or several weeks following implantation of GLIADEL Wafer. Both new seizures and worsening of seizures have been reported.

Brain Swelling: Brain swelling has occurred in clinical studies. In some cases, brain swelling may require another surgery, and removal of GLIADEL Wafers or remnants of the wafers may be required.

Abnormal wound healing: In clinical studies, abnormal healing of the surgical wound has occurred following implantation of GLIADEL Wafer. These abnormalities included reopening of the surgical area, leaking of brain or spinal fluid, delays in healing, or other abnormalities in how the wound heals.

Brain Infections: In clinical studies, brain infections, including meningitis, have occurred following implantation of GLIADEL Wafer.

ADVERSE REACTIONS

The most common adverse reactions in newly-diagnosed high-grade glioma patients are cerebral edema, asthenia, nausea, vomiting, constipation, wound healing abnormalities and depression.

The most common adverse reactions in recurrent high-grade glioma patients are urinary tract infection, wound healing abnormalities and fever.

The Important Safety Information does not include all the information needed to use GLIADEL safely and effectively. For additional safety information, please consult the full Prescribing Information for GLIADEL.

To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.