Copyright © Cephalon, Inc. 2009 All Rights Reserved


PROVIGIL.COM User Agreement

Welcome to the 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 ©2009 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 U.S. 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.


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.


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


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, its 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 U.S. 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.


Contraindications: PROVIGIL is contraindicated in patients with a known hypersensitivity to modafinil or armodafinil or its inactive ingredients.

Serious rash: Serious rash, including Stevens-Johnson Syndrome, requiring hospitalization and discontinuation of treatment has been reported in association with the use of modafinil. There are no factors, including duration of therapy, that are known to predict the risk of occurrence or the severity of rash. Although benign rashes also occur with PROVIGIL, it is not possible to reliably predict which rashes will prove to be serious. PROVIGIL should ordinarily be discontinued at the first sign of rash unless the rash is clearly not drug-related.

PROVIGIL is not approved for use in pediatric patients for any indication.

Angioedema and hypersensitivity reactions: Angioedema and hypersensitivity (with rash, dysphagia, and bronchospasm) were observed in patients treated with armodafinil. Angioedema has been reported in postmarketing experience with modafinil. Multi-organ hypersensitivity reactions, including at least one fatality in post-marketing experience, have occurred in close temporal association to the initiation of modafinil. Patients should be advised to discontinue PROVIGIL and immediately report to their physician any signs or symptoms suggesting multi-organ hypersensitivity, angioedema or anaphylaxis.

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

Persistent sleepiness and CNS effects: Patients should be advised that their level of wakefulness may not return to normal. Although PROVIGIL has not been shown to produce functional impairment, any drug affecting the CNS may alter judgment, thinking or motor skills. Patients should be frequently reassessed for their degree of sleepiness and functional impairment and, if appropriate, advised to avoid driving or any other potentially dangerous activity.

Cardiovascular effects: Cardiovascular adverse reactions have been reported in patients treated with modafinil in association with mitral valve prolapse or left ventricular hypertrophy. PROVIGIL is not recommended 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. If findings of mitral valve prolapse syndrome occur, consider cardiac evaluation. Consider increased monitoring in patients with a recent history of myocardial infarction or unstable angina. In clinical studies, a greater proportion of patients on PROVIGIL required new or increased use of antihypertensive medications compared to patients on placebo. Increased monitoring of heart rate and blood pressure may be appropriate in patients on PROVIGIL. Caution should be exercised when prescribing PROVIGIL to patients with known cardiovascular disease.

Drug interactions: PROVIGIL may interact with drugs that are substrates for CYP3A4/5 or CYP2C19. Dose adjustment of these drugs may be required. The effectiveness of steroidal contraceptives may be reduced when used with PROVIGIL and for one month after discontinuation of therapy.

Common adverse reactions: In clinical trials, the most commonly reported adverse reactions (≥5%) associated with the use of PROVIGIL were headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, and dyspepsia.

PROVIGIL is a Schedule IV controlled substance because it has the potential to be abused or lead to dependence. Physicians should follow patients closely, especially those with a history of drug and/or stimulant abuse.

Physicians should be aware and inform their patients of the availability of the Medication Guide for PROVIGIL.

Please see Full Prescribing Information for PROVIGIL.