iPLEDGE Privacy Notice and Terms of Use

PRIVACY NOTICE

Everyone who wants to take the prescription medication isotretinoin is required to register and participate in the iPLEDGE® Program. In order to help you fulfill the requirements of the program, iPLEDGE must obtain personal information from you. Protecting your privacy is very important to us. Please read the following to learn more about our privacy notice.

What This Privacy Notice Covers

  • This notice covers how iPLEDGE treats personal information that iPLEDGE collects and receives, including information related to your past use of iPLEDGE products and services. Personal information is information about you that is personally identifiable like your name, address, email address, or phone number, and that is not otherwise publicly available.
  • This notice does not apply to the practices of companies that iPLEDGE does not own or control, or to people that iPLEDGE does not employ or manage.

Information Collection and General Use

  • iPLEDGE collects personal information when you register with iPLEDGE, when you use iPLEDGE products or services, and when you visit www.ipledgeprogram.com.
  • When you register as a Prescriber or Pharmacist, we ask for information such as your name, contact information and professional identifier numbers (e.g. DEA, NPI and/or NCPDP numbers). When you register as a Patient, your Prescriber or Prescriber's Designated Agent collects information about you such as your name, email address, birth date, gender, zip code, address, and part of your Social Security number to register you in the iPLEDGE Program. Once you are registered with iPLEDGE and sign in to our services, you are not anonymous to us.
  • As a Patient, we collect health-related information from you, your Prescriber and/or Prescriber's Designated Agent to fulfill requirements to comply with iPLEDGE.
  • iPLEDGE collects information about your transactions within the iPLEDGE Program.
  • iPLEDGE automatically receives and records information on our back-end server logs from your computer, including your IP address - but we do not associate the IP address with a username or any specific web pages visited. We typically store IP Addresses on the server for only 90 days.
    • An IP (Internet Provider) address is a number assigned to your computer for access to the Internet. All computer identification on the Internet is conducted with IP addresses, which allow computers and servers to recognize and communicate with each other.
  • iPLEDGE uses your identifiable personal information to fulfill your requests for products and services, conduct clinical research, and to contact you on iPLEDGE-related matters. Before information is reported to the companies that sponsor iPLEDGE (i.e., the manufacturers) or the FDA, your personal identifying information is removed. We use aggregated (non-personally identifiable) information to help us understand trends, website performance and patient needs. For example, we may analyze the gender or age of visitors to the iPLEDGE site, and we may use that analysis of aggregate data internally or share it with others such as companies that sponsor iPLEDGE (i.e., the manufacturers) and the FDA.

Information Sharing and Disclosure

  • iPLEDGE does not rent or sell personal information about you to other people or nonaffiliated companies for any reason. Furthermore, we do not share personal information about you with other people or affiliated or nonaffiliated companies except to provide products or services you've requested, when we have your permission, or under the following circumstances:
    • We provide information to companies who work on behalf of or with iPLEDGE under confidentiality agreements. These companies may use your personal information to help iPLEDGE communicate with you about matters regarding your health only as it relates to iPLEDGE. These companies do not have any independent right to share or use this information.
    • We respond to subpoenas, court orders, or legal process, or to establish or exercise our legal rights or defend against legal claims;
    • We believe it is necessary to share information in order to investigate, prevent, or take action regarding illegal activities, suspected fraud, situations involving potential threats to the physical safety of any person, violations of iPLEDGE's terms of use, or as otherwise required by law;
    • We transfer information about you if iPLEDGE is acquired by or merged with another company. In this event, iPLEDGE will notify you before information about you is transferred and becomes subject to a different privacy notice.

Webtrends

  • We use a tracking technology called Webtrends®. This technology is used to track how many times each page is visited and how many times a particular document is downloaded. Webtrends is used to analyze trends, and perform diagnostic services such as error reporting to improve this website. We receive reports based on the use of tracking technologies from Webtrends on an individual as well as aggregated basis.
  • Webtrends does not associate page visits to a specific IP address.

Confidentiality and Security

  • We limit access to personal information about you to employees who we believe reasonably need to come into contact with that information to provide products or services to you or in order to do their jobs. Personal information is never used for marketing or sales purposes.
  • We have physical, electronic, and procedural safeguards that comply with federal regulations to protect personal information about you.

Children's Privacy

  • The iPLEDGE website is not intended for any user under the age of 13, and we do not knowingly collect personal information from children under the age of 13. We request that children under the age of 13 not submit any personal information through the iPLEDGE website.

How iPLEDGE Responds to "Do Not Track" Signals

  • Some web browsers have a "Do Not Track" feature. This feature allows you to tell websites you visit that you do not want to have your online activity tracked over time and across websites. These features are not yet uniform across browsers. The iPLEDGE website is not currently set up to respond to those signals.

Changes to this Privacy Notice

  • iPLEDGE may update this notice. We will notify you about significant changes in the way we treat personal information by sending a notice to the primary email address specified in your iPLEDGE account, by placing a prominent notice on our site.

Questions and Suggestions

  • If you have questions or suggestions, please contact us at: 1-866-495-0654.
  • You can also mail the iPLEDGE Program at:

The iPLEDGE Program
P.O. Box 29094
Phoenix, AZ 85038-9978

See also iPLEDGE Program's Terms of Use for additional information.

iPLEDGE TERMS OF USE

Version 2.0. Last Revised: 05/26/2017

These Terms of Use apply to all visitors of the prescription drug risk management site located at http://www.ipledgeprogram.com (the "Site"). The "iPLEDGE Website" is a Registered User-only account portal available through the Site which enables Registered Users to participate with a computer-based risk management program designed to further the public health goal to eliminate fetal exposure to isotretinoin through a special restricted distribution program approved by the FDA.

THIS SITE IS INTENDED FOR U.S. AUDIENCES ONLY. USERS WHO ACCESS THE SITE FROM OUTSIDE THE U.S. DO SO AT THEIR OWN INITIATIVE AND RISK AND ARE RESPONSIBLE FOR COMPLIANCE WITH ALL APPLICABLE LAWS.

"Registered Users" include Patients, Prescribers, Designated Agents, and Pharmacists who have signed up to participate in the iPLEDGE Program. "Patients" are patients that have been prescribed restricted distribution drugs pursuant to the iPLEDGE Program. "Prescribers" are prescribers that prescribe restricted distribution drugs pursuant to the iPLEDGE Program. "Designated Agents" are persons designated by Prescribers to act on their behalf with the iPLEDGE Website. Pharmacists are pharmacists that utilize the iPLEDGE Website to verify a patient's enrollment in iPLEDGE and status before filling a prescription at a retail pharmacy.

These Terms of Use are between a user of any portion of the Site ("you" or "your") and the sponsors of the Site ("iPLEDGE" "we", "us" and "our").

Registration and Assent

Access to and use of the Site is conditioned upon your assent to these Terms of Use. You are deemed to have assented to these Terms of Use when you use any available page of the Site. You are deemed to have assented to these Terms of Use as applicable to the iPLEDGE Website, when you complete the online registration processes required for Registered Users and indicate during the registration process that you accept these Terms of Use along with the Privacy Notice incorporated therein. You are deemed to have accepted these Terms of Use each time you access the Site and each time you use your login credentials to access the iPLEDGE Website portion of the Site. By registering for or otherwise accessing or using the Site, you acknowledge that you have read, understand, and agree to be legally bound by these Terms of Use. These Terms of Use and the Privacy Notice are available during registration for the iPLEDGE Website and on various pages of the Site.

Updates

From time to time, we may, in our sole discretion, modify these Terms of Use, and the Privacy Notice, indicated by a new version number and revision date. The version number includes a major number, a decimal point, and a minor number. A change to the major number reflects a significant change to the notice, while a change to the minor number reflects a less significant change to the notice. Examples of significant changes include additional provisions that reflect new Site functionality, significant modifications to existing provisions, and more significant changes to Site functionality that cause provisions to be modified, added, or removed. Examples of less significant changes include additional provisions that clarify current Site functionality, minor modifications to existing provisions, and less significant changes to Site functionality that cause provisions to be modified, added, or removed.

We will provide you with advance notice of a major change prior to your access of any portion of the Site for which registration is required. For example, we may (i) require that you reaccept the updated version of the web policies, (ii) send you an electronic notification advising of the update to the web policies, (iii) include a notice on the Site viewable without login advising of the update to the web policies, and/or (iv) advise you of the updated web policies during a phone call. We do not ordinarily provide advance notice of a minor change.

It is important that you check these Terms of Use every time you visit the Site. Your use of the Site and/or utilization of any Site benefits after the Terms of Use have been updated (and after advance notice for a major change), indicates your agreement and acceptance of the updated version of the Terms of Use and the Privacy Notice.

User Obligations

You are required to comply with all applicable laws in connection with your use of the Site. As a condition of your use of the Site, you agree that you will not use the Site for any purpose that is unlawful or prohibited by these Terms of Use. You agree that you will only provide information during registration and in connection with any and all other uses of the Site that is true and accurate and is not false, misleading or otherwise an impersonation of any person or entity. Certain portions of the Site may have additional terms and conditions. When these portions are used, you agree to be further bound by the associated additional terms and conditions.

Security of the Site

ACTUAL OR ATTEMPTED UNAUTHORIZED USE OF THE SITE MAY RESULT IN CRIMINAL AND/OR CIVIL PROSECUTION. iPLEDGE RESERVES THE RIGHT TO VIEW, MONITOR, AND RECORD ACTIVITY ON THE SITE WITHOUT NOTICE OR PERMISSION FROM YOU. ANY INFORMATION OBTAINED BY MONITORING, REVIEWING, OR RECORDING IS SUBJECT TO REVIEW BY LAW ENFORCEMENT ORGANIZATIONS IN CONNECTION WITH INVESTIGATION OR PROSECUTION OF POSSIBLE ILLEGAL ACTIVITY ON THE SITE. iPLEDGE WILL ALSO COMPLY WITH ALL COURT ORDERS AS WELL AS ALL LAW ENFORCEMENT AND REGULATORY INQUIRIES INVOLVING REQUESTS FOR SUCH INFORMATION.

Site Content and Intellectual Property Rights

This Site may contain text, images, software (including images or files incorporated in or generated by the software or data accompanying such software), photographs, video, graphics, audio, features, data, designs, images, and other such similar content (collectively "Site Content"). Unless otherwise expressly identified, Site Content is owned by us or by our third-party licensors. The Site Content is protected by United States and international copyright, trademark and other laws. You may browse the Site and download Site Content solely for your personal use, provided you keep intact all copyright and other proprietary notices. Except as expressly permitted, you may not, modify, copy, reproduce, republish, upload, post, transmit, hyperlink to or from, or distribute in any way Site Content from this Site, including code and software underlying this Site, nor may you sell, transfer or otherwise use the Site or the Site Content in commerce or for any public or commercial endeavor without our prior and express written consent. We may in our sole discretion make changes to the Site Content at any time without notice.

No Medical Advice

This Site contains information related to the iPLEDGE REMS Program. The information provided on the Site is for informational purposes or general guidance only, and does not constitute medical advice. Such information is neither a substitute nor intended to be a substitute for the advice provided by a doctor, pharmacist, or other qualified healthcare professional. You agree that you will not use or rely on the information contained herein for diagnosing a health problem or condition. YOU SHOULD CONSULT WITH A DOCTOR BEFORE USING ANY PRODUCT DISCUSSED ON THIS OR ANY OTHER WEBSITE. The receipt of any questions or feedback you submit to us does not create a professional relationship and does not create any privacy interests other than those described in our Privacy Notice.

Linking Notice

Our Site may contain hyperlinks allowing our users to connect to other websites owned by us and our affiliated companies and websites owned by our third-party vendors, distributors, and providers ("Linked Sites"). You may also access our Site through a hyperlink embedded in a Linked Site. We provide hyperlinks to the Linked Sites to enable you to conveniently access websites that may be of interest to you. Please note that once you click on a hyperlink that transfers you from our Site to a Linked Site, you have left our Site, and these Terms of Use will immediately cease to apply to any subsequent activity on the Linked Site. We have not reviewed the content of Websites that may be linked to this Site, make no representations about the content of the Websites, and are not responsible for the content of any other Websites linked to this Site. Linking to any pages off this Site is at your own risk. We are not liable for any damages or injury arising from users' access to such Websites. We are under no obligation to notify you when you have left our Site and have accessed a Linked Site. Use of any Linked Site will be governed by the privacy notice, terms of use, and/or other policies (if any) on the Linked Site.

Use Restrictions

You agree that you will not: (a) use this Site for any purpose that is unlawful, illegal or a violation of applicable Federal, State or local law or that is prohibited by these Terms of Use; (b) engage in any activity or use any device, software or routine that interferes with a user's access to this Site or the proper operation of this Site; (c) delete or revise any Site Content or information of any other user without authorization; (d) take any action that imposes an unreasonable or disproportionately large load on the Site's infrastructure; (e) allow any other person or entity to use your login credentials for posting, copying, extracting, downloading, viewing, transmitting or receiving data of any kind; (f) attempt to decipher, decompile, disassemble or reverse engineer any of the software comprising or in any way making up a part of the Site, or (g) use any automated system or software to extract data from this website or to enter data into this website for commercial purposes ("screen scraping").

Disclaimer of Warranties

THE SITE AND THE SITE CONTENT THEREON ARE PROVIDED ON AN "AS IS", "AS AVAILABLE" BASIS WITHOUT WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED. TO THE FULLEST EXTENT PERMISSIBLE UNDER APPLICABLE LAW, WE EXPRESSLY DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF PERFORMANCE, MERCHANTABILITY, AND FITNESS FOR A PARTICULAR PURPOSE. WHILE WE USE REASONABLE EFFORTS TO INCLUDE ACCURATE AND UP-TO-DATE SITE CONTENT, WE DO NOT WARRANT OR MAKE ANY REPRESENTATIONS REGARDING THE ACCURACY OF RESULTS OR RELIABILITY OF THE SITE OR SITE CONTENT. WE DO NOT MAKE ANY WARRANTY AS TO THE LIFE OF ANY URL. WE DO NOT WARRANT THAT ACCESS TO OR USE OF THE SITE WILL BE UNINTERRUPTED, SECURE, COMPLETE OR ERROR FREE, THAT DEFECTS WILL BE CORRECTED, OR THAT THE SITE OR THE SERVER(S) THAT MAKE THE SITE AVAILABLE ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. BY USING THE SITE, YOU ACKNOWLEDGE THE LIKELIHOOD OF SOME HUMAN AND MACHINE ERRORS, DELAYS, INTERRUPTIONS AND LOSSES, INCLUDING THE INADVERTENT LOSS OF DATA OR DAMAGE TO MEDIA, AND AGREE TO HOLD US HARMLESS FROM AND AGAINST ANY VIRAL INFECTION OR OTHER COMPUTER MALFUNCTION CAUSED AT ALL OR IN PART BY YOUR USE OF THE SITE. YOU ASSUME THE ENTIRE COST OF ALL NECESSARY COMPUTER OR NETWORK SERVICING, REPAIR OR CORRECTION. THE PERFORMANCE OF THE SITE VARIES WITH THE MANUFACTURER'S EQUIPMENT WITH WHICH IT IS USED.

Indemnification by Site User

IN EXCHANGE FOR ACCESSING AND/OR USING THIS SITE, SITE USER AGREES TO INDEMNIFY, DEFEND AND HOLD HARMLESS iPLEDGE AND ITS MEMBERS AND THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, SUPPLIERS AND THIRD PARTY PARTNERS FROM AND AGAINST ALL LOSSES, EXPENSES, DAMAGES AND COSTS, INCLUDING REASONABLE ATTORNEY'S FEES, RESULTING FROM ANY VIOLATION BY YOUR OF THESE TERMS OF USE.

Limitation of Liability

UNDER NO CIRCUMSTANCES WILL iPLEDGE BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES OF ANY KIND, ARISING FROM YOUR USE OF THIS SITE OR DAMAGE CAUSED BY YOUR RELIANCE OF INFORMATION OBTAINED THROUGH THIS SITE, INCLUDING, WITHOUT LIMITATION, LOSS OF BUSINESS OR PROFITS, LOSS OF DATA, COMPUTER VIRUSES, TECHNICAL, HARDWARE OR SOFTWARE FAILURES, UNAVAILABLE OR INTERRUPTED NETWORK CONNECTIONS, BREACH OF SECURITY, OR VIRUSES, WORMS, OR OTHER HARMFUL COMPONENTS, EVEN IF WE HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. YOU SPECIFICALLY ACKNOWLEDGE AND AGREE THAT WE ARE NOT LIABLE FOR THE CONDUCT OF ANY SITE USER. IF YOU ARE DISSATISFIED WITH THE SITE, THE SITE CONTENT, OR THESE TERMS OF USE, YOUR SOLE AND EXCLUSIVE REMEDY IS TO DISCONTINUE USING THE SITE.

Choice of Law and Forum

These Terms of Use shall be governed by and construed in accordance with the laws of the State of New Jersey excluding its conflict of law rules. We each expressly agree to submit to the exclusive jurisdiction and venue of the courts in New Jersey in all disputes arising out of or relating to the use of the Site.

No Waiver

Our failure to enforce any provisions of these Terms of Use or respond to a breach by you or other parties shall not in any way waive our right to enforce subsequently any terms or conditions of these Terms of Use or to act with respect to similar breaches.

Severability and Integration

Unless otherwise specified herein, these Terms of Use and the Privacy Notice incorporated herein constitute the entire agreement between you and us with respect to your use of the Site, subject to the separate terms and conditions of other sites or services to which we provide hyperlinks from this Site. If any portion of these Terms of Use is held invalid or unenforceable, that portion shall be construed in a manner consistent with applicable law to reflect, as nearly as possible, the original intention of the parties, and the remaining portions shall remain in full force and effect.