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WEBSITE TERMS OF USE

The information provided on this Buprenorphine-containing Transmucosal products for Opioid Dependence (BTOD) Risk Evaluation and Mitigation Strategy (REMS) program internet website (“Site”) is for general informational and educational purposes only. Please read and review these Terms of Use carefully before accessing or using this Site. By accessing or using this Site, you acknowledge that you have read, understood and agreed to these Terms of Use and acknowledge that any other agreements between you and the sponsors of the Site (BTOD) concerning the Site are superseded to the extent they conflict with these Terms and Conditions. If you do not agree to the Terms of Use, then do not access or use the Site.

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  1. COPYRIGHT AND TRADEMARK NOTICE
    The entire content of this Site is fully protected under all applicable intellectual property laws, including without limitation copyright, trade dress and trademark laws. Users may print copies of the content of this Site for their personal non-commercial use only, provided you also retain all copyright and other proprietary notices contained in the materials or as specified on the Site. Your use of or linking to any content on the Site, except as provided in these Terms and Conditions, is strictly prohibited. Further printing, copying, redistribution or publication of any part of this Site is strictly prohibited, unless expressly permitted as stated within these Terms of Use or as stated within this Site. Nothing contained on the Site should be construed as granting, by implication, estoppel, or otherwise, any license or right to use any BTOD intellectual property right (including, but not limited to any patent, trademark, trade name, copyright or trade secret).

  2. RESTRICTIONS ON USING THE CONTENT OF THIS WEBSITE
    The content of this Site is for your general information and use only. It is subject to change without notice. The BTOD makes no representation regarding the availability, the accuracy, or the completeness of the content of this Site. The Site contains information about products that may or may not be available in a particular country or region of the world, may be available under different trademarks in different countries and, where applicable, may be approved by government regulatory authority for sale or use with different indications and restrictions in different countries. This Site is intended only for visitors in the United States of America.

    This Site contains information related to the BTOD REMS program. Certain sections of this Site are intended for particular audiences including Prescribers, Pharmacists and Distributors. Such information is neither a substitute nor intended to be a substitute for the advice provided by a licensed healthcare professional. You should not use the information contained herein for diagnosing a health or fitness problem or disease. Users of this Site always should consult a licensed healthcare professional before using any prescription drug product discussed on this Site or any other website. Information on this Site regarding such products approved for marketing is qualified in its entirety by reference to the Full Prescribing Information for such products. Users of this Site should not use this Site to report any side effect, reaction, adverse event, or other problem or issue experienced with any medication, and these events should be reported to the User’s Prescriber or the manufacturer or distributor of such medication.

    While BTOD uses reasonable efforts to include accurate and up-to-date information in its Site, BTOD makes no warranties or representations as to its accuracy. BTOD assumes no liability or responsibility for any errors or omissions in the content of its Site. This Site may provide links or references to other websites not affiliated with BTOD. Such links to other Sites are provided only as a convenience to users of this Site. BTOD has not reviewed all of the websites that may be linked to this Site, and is 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. BTOD shall not be liable for any damages or injury arising from users’ access to such website.

    In the event the Site provides visitors with an opportunity to post messages, you shall not post or transmit any unlawful, threatening, libelous, defamatory, obscene, inflammatory, pornographic or profane material or material that could constitute or encourage conduct that would be considered a criminal offense, give rise to civil liability, or would otherwise violate the law. BTOD shall not be responsible for content posted to its Site by third parties. BTOD respects the privacy of its Site users. Please refer to BTOD’s Privacy Policy which explains how information that is disclosed on this Site will be handled.

  3. INDEMNIFICATION BY SITE USER
    IN EXCHANGE FOR ACCESSING AND/OR USING THIS SITE, SITE USER AGREES TO INDEMNIFY, DEFEND AND HOLD HARMLESS BTOD 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 ATTORNEYS' FEES, RESULTING FROM ANY VIOLATION BY YOU OF THESE TERMS OF USE.

  4. LIMITATION OF LIABILITY
    BTOD provides the contents of its Site for informational purposes and for your general interest only. By using the Site you hereby agree not to rely on any of the information contained herein. UNDER NO CIRCUMSTANCES SHALL BTOD BE LIABLE FOR YOUR RELIANCE ON ANY SUCH INFORMATION NOR SHALL BTOD BE LIABLE FOR DAMAGES OF ANY KIND, INCLUDING, WITHOUT LIMITATION, ANY DIRECT, INCIDENTAL, SPECIAL CONSEQUENTIAL, INDIRECT OR PUNITIVE DAMAGES THAT RESULT FROM THE USE OF, OR THE INABILITY TO USE, THE MATERIALS IN THIS SITE OR THE MATERIALS IN ANY SITE WHICH MAY BE LINKED TO THIS SITE, EVEN IF BTOD OR A BTOD AUTHORIZED REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. APPLICABLE LAW MAY NOT ALLOW THE LIMITATION OR EXCLUSION OF LIABILITY OR INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. IN NO EVENT SHALL BTOD’S TOTAL LIABILITY TO YOU FOR ALL DAMAGES, LOSSES, AND CAUSES OF ACTION WHETHER THE CAUSE OF ACTION IS IN CONTRACT, TORT (INCLUDING, BUT NOT LIMITED TO, NEGLIGENCE) OR OTHERWISE EXCEED THE AMOUNT PAID BY YOU, IF ANY, FOR ACCESSING THIS SITE.

  5. DISCLAIMER OF WARRANTIES
    THE MATERIALS IN THIS SITE ARE PROVIDED "AS IS" AND WITHOUT WARRANTIES OF ANY KIND EITHER EXPRESS OR IMPLIED. TO THE FULLEST EXTENT PERMISSIBLE PURSUANT TO APPLICABLE LAW, BTOD DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. BTOD DOES NOT WARRANT THAT THE FUNCTIONS CONTAINED IN THE MATERIALS WILL BE UNINTERRUPTED OR ERROR-FREE, THAT DEFECTS WILL BE CORRECTED, OR THAT THIS SITE OR THE SERVER THAT MAKES IT AVAILABLE ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. BTOD DOES NOT WARRANT OR MAKE ANY REPRESENTATIONS REGARDING THE USE OR THE RESULTS OF THE USE OF THE MATERIALS IN THESE SITES IN TERMS OF THEIR CORRECTNESS, ACCURACY, RELIABILITY, OR OTHERWISE. YOU (AND NOT BTOD) ASSUME THE ENTIRE COST OF ALL NECESSARY SERVICING, REPAIR OR CORRECTION. APPLICABLE LAW MAY NOT ALLOW THE EXCLUSION OF IMPLIED WARRANTIES, SO THE ABOVE EXCLUSION MAY NOT APPLY TO YOU.

  6. JURISDICTIONAL ISSUES/EXPORT RESTRICTIONS
    This Site is intended to be used only by visitors and users who are residents of the United States. Users who access the Site from outside the United States do so at their own initiative and risk and are responsible for compliance with all applicable laws. These Terms of Use shall be governed by and construed in accordance with the laws of the State of New York, without giving effect to any principles of conflicts of law. All actions or proceedings arising out of or related to these terms, your use of the Site, or anything related to the Site, shall be exclusively resolved through litigation in any local, state or federal court located in New York. You hereby unconditionally consent to personal jurisdiction in any local, state or federal courts located in New York and hereby waive any objection to process based on personal jurisdiction. If any provision of these Terms of Use shall be unlawful, void, or for any reason unenforceable, then that provision shall be deemed severable from these Terms of Use and shall not affect the validity and enforceability of any remaining provisions. This is the entire Agreement between the parties relating to the subject matter herein. Software from this Site is further subject to United States export controls. No software from this Site may be downloaded or otherwise exported or re-exported

    1. into (or to a national or resident of) Cuba, Iraq, Libya, North Korea, Iran, Syria or any other country subject to United States export control restrictions; or
    2. to anyone on the U.S. Treasury Department’s list of Specially Designated Nationals or the U.S. Commerce Department’s Table of Denial Orders. By downloading or using the Software, you represent and warrant that you are not located in, under the control of, or a national or resident of any such country or on any such list.

  7. UNSOLICITED INFORMATION
    By submitting any unsolicited information and materials, including comments, ideas, questions, designs, and other similar communications (collectively, “Unsolicited Information”) to BTOD through the Site, you agree to be bound by the following terms and conditions. If you do not agree with these terms and conditions, you should not provide any Unsolicited Information through the Site. All Unsolicited Information will be considered NON-CONFIDENTIAL and NON-PROPRIETARY. BTOD may use such communication or material for any purpose whatsoever, including, but not limited to, reproduction, disclosure, transmission, publication, broadcast, and further posting. Further, BTOD is free to use any ideas, concepts, know-how, or techniques contained in any communication or material you send to the Site for any purpose whatsoever, including, but not limited to, developing, manufacturing, and marketing products. By submitting any Unsolicited Information, you are granting us a perpetual, royalty-free and irrevocable right and license to use, reproduce, modify, adapt, publish, translate, distribute, transmit, publicly display, publicly perform, sublicense, create derivative works from, transfer and sell such Unsolicited Information and to use your name and other identifying information in connection with such Unsolicited Information.

    Under no circumstances, should you use this Site or any of the fax and mailing addresses on the Site to send BTOD confidential or proprietary information. BTOD does not want to receive such confidential or proprietary information.

  8. LINKING POLICY
    Links Out — This Site may provide links or references to other website not affiliated with BTOD. BTOD has not reviewed the content of websites that may be linked to its Site, makes no representations about the content of the websites, and is 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. BTOD shall not be liable for any damages or injury arising from users' access to such website.

    Links In — Unless otherwise set forth in a written agreement between you and BTOD, you must adhere to BTOD's linking policy as follows:

    1. any link to a BTOD Site must be a text only link clearly marked with the name of the BTOD website,
    2. the appearance, position and other aspects of the link may not be such as to damage or dilute the goodwill associated with BTOD 's name or trademarks,
    3. the link must point to the BTOD website URL homepage and not to other pages within the website,
    4. the appearance, position and other attributes of the link may not create the false appearance that your organization or entity is sponsored by, associated with, or affiliated with BTOD or the Site,
    5. when selected by the user, the link must display the website on full screen and not within a "frame" on the linking website, and
    6. the linked website must comply with all applicable U.S. laws, rules, and regulations. BTOD shall not be liable for any damages or injury arising from such Links in any BTOD Site.

  9. SECURITY OF THE SITE
    ACTUAL OR ATTEMPTED UNAUTHORIZED USE OF THE SITE MAY RESULT IN CRIMINAL AND/OR CIVIL PROSECUTION. BTOD 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. BTOD WILL ALSO COMPLY WITH ALL COURT ORDERS AS WELL AS ALL LAW ENFORCEMENT AND REGULATORY INQUIRIES INVOLVING REQUESTS FOR SUCH INFORMATION.



This REMS does not apply to buprenorphine-containing products indicated for the treatment of pain or for products dispensed to patients admitted to Opioid Treatment Programs (OTP) under 42 CFR part 8.
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Last Updated May 2022