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Privacy Statement and Terms of Use Effective August 23, 2004 PLEASE READ THE FOLLOWING PRIVACY STATEMENT AND TERMS OF USE (collectively, “Terms”) CAREFULLY. These Terms apply to anyone who visits this site. By using this site, you agree to these Terms. If you do not agree with these Terms, please do not use this site. We reserve the right to change these Terms at any time by posting revised terms on this site. Your continued use of this site following the posting of changes means you accept the changes. Privacy and Collection of Information The Azur Pharma FazaClo® Patient Registry (“Registry”) is a national registry of health care practitioners and pharmacists that prescribe and dispense FazaClo® and patients taking FazaClo®. The Registry is mandated by the U.S. Food and Drug Administration (“FDA”) as a condition of our marketing FazaClo® in the United States. The following paragraphs describe the collection, security and use of information through this site and otherwise in connection with the operation of the Registry. Collection of Information We collect personally identifiable information through this site and otherwise in connection with the operation of the Registry. This information includes names, contact and identifying information concerning health care practitioners and pharmacists that prescribe and dispense FazaClo® and patients taking FazaClo®, as well as patient medical information and information necessary for us to process and verify orders for FazaClo® Patient Registry Starter Packets and demo CD-ROMs. Health care practitioners and pharmacists must register with the Registry to prescribe or dispense FazaClo®. You are required to provide certain information as part of the online registration process if you wish to prescribe or dispense FazaClo®. When you complete the registration process, you represent that you are a health care practitioner or pharmacist duly licensed in the jurisdictions in which you practice and that the information you provide as part of the registration process is accurate. If you register to prescribe or dispense FazaClo®, you thereby agree to provide, through the secure area of the Registry website, accurate required information concerning the patients to whom you prescribe or dispense FazaClo®. The Health Insurance Portability and Accountability Act (“HIPAA”) patient privacy regulations permit disclosure by health care professionals of “protected health information,” without patient consent, to fulfill certain requirements as mandated by the FDA. Please see 45 C.F.R. § 164.512(b)(iii). The Registry website provides a process for
health care practitioners and pharmacists to review and change certain information
previously provided to us by using the tools provided on the site. While security of a computer system can never be guaranteed, the Registry is designed to be accessible only to registered users with a user ID and password obtained from the FazaClo® Patient Registry Coordinating Center. The Registry is designed to provide health care practitioners and pharmacists access to information concerning only those patients registered to them. Data security is accomplished using 128-bit data encryption standards. All data communications are encrypted and require 128-bit Secure Sockets Layer browser support. Use and Disclosure of Information Patient information we collect through this site and otherwise in connection with the operation of the Registry will be used and disclosed only for purposes of the Registry as permitted by HIPPA or the FDA. Other information that we collect may be used for our business purposes, but we will not disclose such information to anyone outside Azur Pharma, its affiliates, successors and service providers, unless we have a good faith basis to believe that we are required to do so by law or that you are in violation of these Terms or law. Other Terms of Use Copyrights and Trademarks The contents of this site are the property of Azur Pharma and are protected under copyright and trademark laws. The site may also include trademarks or service marks of third parties, which are the property of their respective owners. Use of Site Azur Pharma gives you permission to browse through any public areas of the site or secure areas accessible with your user ID and password, and to print and download copies of material in such areas for your personal, non-commercial use only, so long as you do not remove any copyright or other notices that appear on the material you print or download. Any such printing and downloading is at your own risk. You agree that you will not otherwise copy, display or transmit any material on the site in any manner or medium. You also agree not to create derivative works of, sell or distribute any material on the site. If you obtain a user ID and password to access the Registry website, you agree to keep your user ID and password secret and not allow use of your user ID and password to access the Registry by anyone other than your employees acting under your direct supervision. You are responsible for all use of your user ID and password. All users agree not to disrupt or impair this site or the Registry, not to participate in a denial of service attack against this site or against any other web site by using this site, not to access any account other than your own or access or collect any information of others, and not to otherwise engage in any other unlawful activity in regards to this site or the Registry. Disclaimers THIS SITE IS PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS. AZUR PHARMA RESERVES THE RIGHT TO RESTRICT OR TERMINATE YOUR ACCESS TO THE SITE AND TO MODIFY THE SITE AT ANY TIME. AZUR PHARMA DISCLAIMS ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND ANY WARRANTIES THAT MATERIAL ON THE SITE IS NONINFRINGING, THAT ACCESS TO THE SITE WILL BE UNINTERRUPTED OR ERROR-FREE, THAT THE SITE WILL BE SECURE, OR THAT INFORMATION ON THE SITE WILL BE COMPLETE OR ACCURATE. Limitation of Liability TO THE FULLEST EXTENT PERMISSIBLE UNDER APPLICABLE LAW, YOU AGREE THAT NEITHER AZUR PHARMA NOR ANY OF ITS AFFILIATES, SUCCESSORS OR SERVICE PROVIDERS SHALL BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, PUNITIVE, EXEMPLARY OR ANY OTHER DAMAGES RELATING TO OR RESULTING FROM YOUR USE OF OR INABILITY TO USE THIS SITE. THIS LIMITATION APPLIES REGARDLESS OF THE LEGAL BASIS FOR YOUR ASSERTING A CLAIM TO DAMAGES, AND EVEN IF WE OR OUR REPRESENTATIVES HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. Arbitration Any dispute relating in any way to these Terms, the site or the Registry shall be submitted to confidential arbitration in Los Angeles, California, except that Azur Pharma may seek injunctive or other appropriate relief in any state or federal court of competent jurisdiction in the case of any claim that a user of the site has violated the “Use of Site” section of these Terms. Such arbitration shall be conducted under the Commercial Arbitration Rules of the American Arbitration Association. The arbitrator’s award shall be binding and may be entered as a judgment in any court of competent jurisdiction. Jurisdiction The laws of the State of California govern these Terms and your use of the site. This site is provided in connection with the marketing of FAZACLO® in the United States. Nothing on this site should be regarded as marketing of FAZACLO® in any other jurisdiction. We market products only in compliance with the laws of the particular jurisdictions in which they are sold. We recognize that it is possible for you to obtain access to this site from any jurisdiction in the world, but we have no practical ability to prevent such access. If any material on this site, or your use of the site, is contrary to the laws of the place where you are when you access it, the site is not intended for you, and we ask you not to use the site. Miscellaneous These Terms are the entire agreement between you
and Azur Pharma regarding the site and the Registry. If any provision of these
Terms is unlawful, void or unenforceable, that condition shall not
affect the enforceability of the remaining provisions. Azur Pharma’s waiver or
failure to require performance of these Terms in any instance shall not
act as a waiver or bar in any subsequent or other instance. These Terms
bind and inure to the benefit of your and our respective heirs,
successors and assigns.
The Azur Pharma FazaClo® Patient Registry is a program
mandated by the Food and Drug Administration. Azur Pharma is
required to collect patient identification information, patient lab data
and investigate adverse events associated with its product.
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