Terms and conditions

Copyright ©2008 Cephalon, Inc. All Rights Reserved. BEFORE ACCESSING THIS SITE, PLEASE READ THE FOLLOWING TERMS AND CONDITIONS CAREFULLY AS THEY GOVERN YOUR USE OF THIS SITE. IF YOU DO NOT AGREE WITH THESE TERMS AND CONDITIONS, YOU ARE NOT GRANTED PERMISSION BY CEPHALON, INC. TO ACCESS OR OTHERWISE USE THIS SITE.

NUVIGIL.COM User Agreement

Welcome to the NUVIGIL.com Web site (also referred to as the "Site") owned and operated by Cephalon, Inc ("Cephalon"). This Agreement contains the terms, covenants, conditions, and provisions (the "Terms and Conditions") upon which you ("You") may access and use this Site.

Terms and Conditions

By accessing, viewing, or using this Site, You, the User, indicate that you understand and intend these Terms and Conditions to be the legal equivalent of a signed, written contract and equally binding, and that you accept such Terms and Conditions and agree to be legally bound by them. Please note that Cephalon reserves the right to change these Terms and Conditions. Your continued use of this Site following such modifications will be conclusively deemed acceptance of any changes to these Terms and Conditions.

License Grant

This Agreement provides You with a personal, revocable, nonexclusive, nontransferable license to use this Site conditioned on Your continued compliance with the Terms and Conditions of this Agreement. You may print and download materials and information on this Site solely for personal and noncommercial use, provided that all hard copies contain all copyright and other applicable notices contained in such materials and information. As a further condition of use of this Site, You warrant to Cephalon that You will not use this Site for any purpose that is unlawful or otherwise prohibited by these Terms and Conditions.

Intellectual Property Rights

All materials contained in the Site are protected by law, including but not limited to United States copyright, trade secret, and trademark law, as well as other state, national, and international laws and regulations. The contents of and all materials distributed in conjunction with the Site are Copyright ©2008 Cephalon, Inc. or its licensors or suppliers. All rights reserved. Cephalon also owns a copyright in the Site as a collective work and/or compilation, and in the selection, coordination, arrangement, and enhancement of such content. Republication or citation of any other content generated by the Site without Cephalon's written consent is expressly prohibited. You agree not to copy, modify, adapt, frame, mirror, reproduce, translate, distribute, transmit, reverse engineer, decompile, or disassemble any aspect of the Site, except as expressly allowed by this Agreement. All product names, whether or not appearing in large print, italics or with the trademark symbol, are trademarks of Cephalon, Inc., its affiliates, related companies or its licensors or joint venture partners and any use of such marks without the express written permission of Cephalon is strictly prohibited. Unauthorized use of any material contained on this Site may violate copyright laws, trademark laws, trade secret laws, the laws of privacy and publicity, and communications regulations and statutes. Please be aware that Cephalon actively and aggressively enforces its intellectual property rights to the fullest extent of the law.

Copyright Owners' Rights Under the Digital Millennium Copyright Act of 1998

The Digital Millennium Copyright Act of 1998 (the "DMCA") provides recourse for copyright owners who believe that material appearing on the Internet infringes their rights under US copyright law. If You believe in good faith that materials hosted by Cephalon infringe your copyright, You (or your agent) may send us a notice requesting that the materials be removed, or access to them blocked. If You believe in good faith that a notice of copyright infringement has been wrongly filed against You, the DMCA permits You to send us a counter-notice.

Notices and counter-notices must meet statutory requirements imposed by the DMCA. One place to find more information on the DMCA is the US Copyright Office Web site. Notices and counter-notices for the Site should be sent to Robert T. Hrubiec, Ph.D., J.D., Intellectual Property, Cephalon Inc., 145 Brandywine Parkway, West Chester PA 19380.

Submissions

Cephalon welcomes your feedback and suggestions about how to improve this Site. Any ideas, suggestions, information, know-how, material, or other content (collectively, "Content") received through this Site, however, will be deemed to include a royalty-free, perpetual, irrevocable, transferable, worldwide, nonexclusive right and license for Cephalon to adopt, publish, reproduce, disseminate, transmit, distribute, copy, use, create derivative works, display (in whole or part), or act on such Content without additional approval or consideration, in any form, media, or technology now known or later developed for the full term of any rights that may exist in such Content.

Jurisdiction

The information provided on this Site is intended for US audiences and has been designed to comply with US regulatory guidelines.

Disclaimer

Medical information that appears on this Web site is for informational purposes only and is not, nor is intended to be, a medical diagnosis or a replacement for advice given by a physician or other medical professional. Any reliance on the information provided on this Web site is solely the responsibility of the individual. While Cephalon, Inc. makes reasonable efforts to ensure the timeliness and accuracy of the materials present on this Web site, it makes no assurances or warranties (express or implied) as to the accuracy of the information provided on this Web site and shall not be liable for any direct, indirect, incidental, consequential or otherwise special damages or injuries resulting from the use of this Web site and reliance on the materials contained here. Cephalon, Inc. may make changes to these materials at any time, without notice, and makes no commitment to update the information contained herein.

This Web site may link you to other Web sites that are not owned or controlled by Cephalon, Inc. Links are provided for your convenience only. These sites are maintained by entities over which Cephalon, Inc. exercises no control. Accordingly, Cephalon, Inc. expressly disclaims any responsibility for the content, the accuracy of the information and/or quality of products or services provided by or advertised on these third-party sites. If you choose to hyperlink to another Web site, you do so at your own risk.

Forward Looking Statement

This Web site contains "forward looking statements" in addition to historical facts or statements of current conditions. Forward looking statements provide Cephalon, Inc.'s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings projections, and other statements regarding matters that are not historical facts. You may identify some of these forward looking statements by the use of words in the statements such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," or other words and terms of similar meaning. Cephalon, Inc.'s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory, and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties such as those set forth below and in its reports on Form 8-K, 10-Q and 10-K filed with the US Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward looking statements. Furthermore, Cephalon, Inc. is not obligated and does not intend to update publicly any forward looking statements. This discussion is permitted by the Private Securities Litigation Reform Act of 1995.

Important Information for Physicians


Indications

NUVIGIL is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSA), shift work sleep disorder and narcolepsy.

In OSA, NUVIGIL is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice, the encouragement of and periodic assessment of CPAP compliance is necessary and a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL. Careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is important. Prescribers should be aware that some patients may have more than one sleep disorder contributing to their excessive sleepiness.

Important Safety Information

Warnings

Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults in association with the use of armodafinil and in adults and children in association with use of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL).

No serious skin rashes have been reported in adult clinical trials (0 per 1,595) of armodafinil. However, cases of serious rash have been reported in adults in postmarketing experience. Because armodafinil is the R isomer of modafinil, a similar risk of serious rash in pediatric patients with armodafinil cannot be ruled out.

In clinical trials of modafinil, the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in pediatric patients; these rashes included 1 case of possible Stevens-Johnson Syndrome (SJS) and 1 case of apparent multi-organ hypersensitivity reaction. Several of the cases were associated with fever and other abnormalities (e.g., vomiting, leukopenia). No serious skin rashes have been reported in adult clinical trials of modafinil. Rare cases of serious or life-threatening rash, including SJS, Toxic Epidermal Necrolysis (TEN) and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in postmarketing experience with modafinil.

Although benign rashes occur with NUVIGIL, it is not possible to reliably predict which rashes will prove to be serious. NUVIGIL should ordinarily be discontinued at the first sign of rash unless the rash is clearly not drug-related.

NUVIGIL has not been studied in pediatric patients in any setting and is not approved for use in pediatric patients for any indication.

One serious case of angioedema and one case of hypersensitivity (with rash, dysphagia, and bronchospasm) were observed among patients treated with NUVIGIL. Patients should be advised to discontinue therapy and immediately report to their physician any signs or symptoms suggesting angioedema or anaphylaxis.

Multi-organ hypersensitivity reactions, including at least 1 fatality postmarketing, have occurred in close temporal association to the initiation of modafinil. If a multi-organ hypersensitivity reaction is suspected, NUVIGIL should be discontinued.

Patients should be advised that their level of wakefulness may not return to normal. Patients should be frequently reassessed for their degree of sleepiness and, if appropriate, advised to avoid driving or any other potentially dangerous activity.

Psychiatric adverse experiences have been reported in patients treated with modafinil. Postmarketing adverse events associated with the use of modafinil have included mania, delusions, hallucinations, suicidal ideation and aggression, some resulting in hospitalization. In controlled trials in adults administered NUVIGIL, psychiatric symptoms resulting in treatment discontinuation were anxiety, agitation, nervousness, and irritability. Caution should be exercised when NUVIGIL is given to patients with a history of psychosis, depression, or mania. Consider discontinuing NUVIGIL if psychiatric symptoms develop.

Precautions

  • Although NUVIGIL has not been shown to produce functional impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Patients should be cautioned about operating an automobile or other hazardous machinery until reasonably certain that NUVIGIL therapy will not adversely affect their ability to engage in such activities.
  • Patients with a recent history of myocardial infarction or unstable angina should be treated with caution. NUVIGIL should not be used in patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced mitral valve prolapse syndrome when previously receiving CNS stimulants. There were also a greater proportion of patients on NUVIGIL requiring new or increased use of antihypertensive medications compared to patients on placebo. Increased monitoring of blood pressure may be appropriate in patients on NUVIGIL.
  • NUVIGIL may interact with drugs that inhibit, induce, or are metabolized by cytochrome P450 isoenzymes.
  • The effectiveness of steroidal contraceptives may be reduced when used with NUVIGIL and for one month after discontinuation of therapy.
  • The concomitant use of NUVIGIL and alcohol has not been studied and should be avoided.

Common Adverse Reactions

In clinical trials, the most commonly reported adverse events (≥5%) were headache, nausea, dizziness, and insomnia. Most adverse experiences were rated as mild to moderate.

Drug Abuse and Dependence

NUVIGIL is a Schedule IV drug. Although the abuse potential of NUVIGIL has not been studied, its abuse potential is likely to be similar to that of modafinil. Modafinil produces psychoactive and euphoric effects, alterations in mood, perception, thinking and feelings typical of other CNS stimulants. Physicians should follow patients closely, especially those with a history of drug and/or stimulant abuse.

Please see full prescribing information for NUVIGIL.