Terms & Conditions

Acceptance of Terms.

The following terms and conditions govern all use of the HETLIOZPRO.com website (the Site). The Site is offered subject to acceptance without modification of any of the terms and conditions contained herein or all other operating rules, policies and procedures that may be published from time to time on this Site by Vanda Pharmaceuticals Inc. (collectively, the Terms of Use).

IF YOU DO NOT AGREE TO ALL OF THESE TERMS OF USE, THEN DO NOT ACCESS OR USE THE SITE. BY VIEWING THE SITE, YOU AGREE TO BE BOUND BY ALL OF THESE TERMS OF USE.

Changes.

Vanda reserves the right, at its sole discretion, to modify or replace any of these Terms of Use at any time. It is your responsibility to check the Terms of Use periodically for changes. Your continued use of the Site following the posting of any changes to the Terms of Use constitutes acceptance of those changes.

Information and Subscriptions.

At your election, you may request (and Vanda may provide) additional information about Vanda or subscribe to various information services concerning Vanda's products, services and business (the Service). When you do so, the registration process requires you to provide certain information, for example, your name, profession, email address and certain additional information about your preferences, such as, for example, your preferred contact method and product markets of interest to you (collectively, Your Information). You may initiate your subscription at http://www.HETLIOZPRO.com/registration. Vanda may terminate your access to all or any part of the Service at any time, with or without cause, with or without notice, effective immediately.

Privacy.

Vanda's current privacy policy is available at www.vandapharma.com/privacy.html (the Privacy Statement), which is incorporated by this reference. Vanda will not edit, delete or disclose the contents of Your Information in connection with the Service unless (1) reasonably necessary to perform the Service, (2) authorized by you, (3) otherwise permitted under the Privacy Statement or (4) Vanda is required to do so by law or regulation, or in the good faith belief that such action is necessary to (i) conform or comply with applicable laws, regulations or legal process, (ii) protect or defend the rights or property of Vanda or any other user or (iii) enforce the Terms of Use.

Rules and Conduct.

As a condition of use, you promise not to use the Site for any purpose that is unlawful or prohibited by these Terms of Use, or any other purpose not reasonably intended by Vanda. You agree to abide by all applicable local, state, national and international laws and regulations.

Use of Site Information.

The Site may contain forward-looking statements and information relating to Vanda that are based on Vanda's beliefs as well as assumptions made by and information currently available to it. The words "anticipate," "believe," "estimate," "expect," "intend," "will," and similar expressions, as they relate to Vanda, are intended to identify forward-looking statements. Actual results could differ materially from those projected in such forward-looking statements. Vanda does not intend to update these forward-looking statements.

Third Party Sites.

The Site may permit you to link to other websites on the Internet, and other websites may contain links to the Site. These other websites are not under Vanda's control, and you acknowledge that Vanda is not responsible for the accuracy, legality, appropriateness or any other aspect of the content or function of such websites. The inclusion of any such link does not imply endorsement by Vanda or any association with its operators.

Proprietary Rights.

You agree that all content and materials delivered via the Site and the Service or otherwise made available by Vanda at the Site are protected by copyrights, trademarks, service marks, patents, trade secrets or other proprietary rights and laws. Except as expressly authorized by Vanda in writing, you agree not to sell, license, rent, modify, distribute, copy, reproduce, transmit, publicly display, publicly perform, publish, adapt, edit or create derivative works from such materials or content. However, you may print or download a reasonable number of copies of the materials or content at this Site for your internal business purposes; provided, that you retain all copyright and other proprietary notices contained therein.

No Warranties.

THE SITE AND ALL MATERIALS, INFORMATION, SOFTWARE, PRODUCTS AND SERVICES INCLUDED IN OR AVAILABLE THROUGH THE SITE (THE CONTENT) ARE PROVIDED "AS IS" AND "AS AVAILABLE". THE SITE, SERVICE AND CONTENT ARE PROVIDED WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, AND ANY WARRANTIES IMPLIED BY ANY COURSE OF PERFORMANCE OR USAGE OF TRADE, ALL OF WHICH ARE EXPRESSLY DISCLAIMED. VANDA, AND ITS AFFILIATES, LICENSORS AND SUPPLIERS DO NOT WARRANT THAT: (A) THE CONTENT IS TIMELY, ACCURATE, COMPLETE, RELIABLE OR CORRECT; (B) THE SITE WILL BE SECURE OR AVAILABLE AT ANY PARTICULAR TIME OR LOCATION; (C) ANY DEFECTS OR ERRORS WILL BE CORRECTED; (D) THE CONTENT IS FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS; OR (E) THE RESULTS OF USING THE SITE OR SERVICE WILL MEET YOUR REQUIREMENTS. YOUR USE OF THE SITE AND/OR SERVICE IS SOLELY AT YOUR OWN RISK.

Limitation of Liability.

IN NO EVENT SHALL VANDA (OR ITS AFFILIATES, LICENSORS AND SUPPLIERS) BE LIABLE CONCERNING THE SUBJECT MATTER OF THIS AGREEMENT, REGARDLESS OF THE FORM OF ANY CLAIM OR ACTION (WHETHER IN CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE), FOR ANY (A) MATTER BEYOND ITS REASONABLE CONTROL, (B) LOSS OR INACCURACY OF DATA, LOSS OR INTERRUPTION OF USE, OR COST OF PROCURING SUBSTITUTE TECHNOLOGY, GOODS OR SERVICES, OR (C) DIRECT OR INDIRECT, PUNITIVE, INCIDENTAL, RELIANCE, SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES INCLUDING, BUT NOT LIMITED TO, LOSS OF BUSINESS, REVENUES, PROFITS OR GOODWILL, EVEN IF VANDA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THESE LIMITATIONS ARE INDEPENDENT FROM ALL OTHER PROVISIONS OF THIS AGREEMENT AND SHALL APPLY NOTWITHSTANDING THE FAILURE OF ANY REMEDY PROVIDED HEREIN.

Miscellaneous.

These Terms of Use shall be governed by and construed in accordance with the laws of the State of Maryland, excluding its conflicts of law rules, and the United States of America. If any provision of the Terms of Use is found to be unenforceable or invalid, that provision will be limited or eliminated to the minimum extent necessary so that the Terms of Use will otherwise remain in full force and effect and enforceable. Vanda may assign, transfer or delegate any of its rights and obligations hereunder without consent. All waivers and modifications must be in a writing signed by Vanda, except as otherwise provided herein. No agency, partnership, joint venture, or employment relationship is created as a result of this Agreement and neither party has any authority of any kind to bind the other in any respect.

Copyright and Trademark Notices.

Unless otherwise indicated, these Terms of Use and all Content provided by Vanda are copyright ©2014 Vanda Pharmaceuticals Inc. All rights reserved.

VANDA, HETLIOZ, HETLIOZSolutions are trademarks or registered trademarks of Vanda Pharmaceuticals Inc. in the United States and other countries. The names of actual companies and products mentioned at the Site may be the trademarks of their respective owners.

Contact

You may contact Vanda Pharmaceuticals Inc. at the following address:
Vanda Pharmaceuticals Inc.
2200 Pennsylvania Ave NW
Suite 300E
Washington, DC 20037
Tel: 202.734.3400
Fax: 202.296.1450
Email: info@vandapharma.com

Healthcare Provider Important Safety Information

The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® (tasimelteon) than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.

Indication

HETLIOZ® (tasimelteon) capsules are indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in adults and nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older. HETLIOZ LQ® oral suspension is indicated for the treatment of nighttime sleep disturbances in SMS in patients 3 to 15 years of age.

Important Safety Information

  • HETLIOZ® may cause somnolence: After taking HETLIOZ®, patients should limit their activity to preparing for going to bed, because HETLIOZ® can potentially impair the performance of activities requiring complete mental alertness.
  • The most common adverse reactions (incidence >5% and at least twice as high on HETLIOZ® than on placebo) were headache, increased alanine aminotransferase, nightmares or unusual dreams, and upper respiratory or urinary tract infection. The risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to HETLIOZ® is increased by approximately 2-fold compared with younger patients.Adverse reactions were similar in patients treated for Non-24 and patients with SMS treated for nighttime sleep disturbances. Adverse reactions were also similar in pediatric patients (3 years to 15 years) who received HETLIOZ LQ® oral suspension, and patients ≥16 years of age who received HETLIOZ capsules
  • Use of HETLIOZ® should be avoided in combination with fluvoxamine or other strong CYP1A2 inhibitors, because of a potentially large increase in exposure of HETLIOZ®, and a greater risk of adverse reactions. HETLIOZ® should be avoided in combination with rifampin or other CYP3A4 inducers, because of a potentially large decrease in exposure of HETLIOZ®, with reduced efficacy.
  • There are no adequate and well-controlled studies of HETLIOZ® in pregnant women. Based on animal data, HETLIOZ® may cause fetal harm. Caution should be exercised when HETLIOZ® is administered to a nursing woman.
  • HETLIOZ® has not been studied in patients with severe hepatic impairment and is not recommended in these patients.
  • The safety and effectiveness of HETLIOZ® for the treatment of Non-24 in pediatric patients have not been established. The safety and effectiveness of HETLIOZ LQ® oral suspension for the treatment of nighttime sleep disturbances in SMS have been established in pediatric patients 3 years and older.
  • To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals Inc. at 1-844-438-5469 or www.hetlioz.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full US Prescribing Information.