TERMS OF USE

Effective Date: August 23, 2006

Please Read Carefully Prior To Using This Web Site

I. Acceptance of Terms and Conditions

Use of this BioMarin Pharmaceutical Inc. (“BioMarin”) Web site (this “Web site”) is governed by the terms and conditions below. These terms and conditions are legally binding on all users of this Web site. By accessing this Web site, you agree to abide by these terms and conditions. If you do not agree with any of these terms and conditions please do not use this Web site, because by using the Web site you will be deemed to have irrevocably agreed to these terms and conditions.

II. Intellectual Property Rights

1. Ownership
   All content, text, images, data, information and other material displayed, available, or present on this Web site (“Content”) are the property of BioMarin, its affiliates, its licensors or the designated owners. Such Content is protected by applicable intellectual property laws, such as the laws governing copyrights and trademarks. You should assume that everything you see or read on this Web site is copyrighted unless otherwise noted, and may not be used without the written permission of BioMarin, except as provided in these terms and conditions.
2. Authorized and Prohibited Uses
   You may access, use and display this Web site on a single computer only and download and print copies of the Content only for non-commercial, informational, personal use, without modification or alteration in any way, and only so long as you comply with these terms and conditions and applicable laws. You agree not to infringe upon any intellectual property rights or remove or modify related proprietary notices contained in this Web site or the Content.
3. User Content
   Except as provided in BioMarin’s Privacy Notice (as defined below) for this Web site, any Content that you submit to this Web site or to BioMarin (“User Content”) will be deemed to be non-confidential and nonproprietary and may be disclosed through this Web site to unknown persons on a worldwide basis without control by BioMarin, including for browsing, downloading, printing and other uses by such other persons or entities. You are responsible for making sure that you have the right to submit Content to this Web site or to BioMarin and that BioMarin has the right to post the Content you submit. BioMarin shall have an unrestricted license (including the right to sublicense) to translate, reproduce, sell, publish, distribute, modify, display, link to or use, in any form or media, any Content you submit to this Web site or to BioMarin. BioMarin does not endorse any User (or third party user) Content, product or service that may appear on this Web site. Nothing in these terms and conditions shall obligate BioMarin to use any User Content, or to include or post such Content on this Web site.
4. Digital Millennium Copyright Act Compliance
   BioMarin respects the rights of all copyright holders and in this regard, BioMarin has adopted and implemented a policy that provides for the termination of a user’s privileges in appropriate circumstances who infringes the rights of copyright holders. If you believe that your work has been copied in a way that constitutes copyright infringement, please provide BioMarin’s Copyright Agent the following information required by the Digital Millennium Copyright Act, 17 U.S.C. Section 512:
1. A physical or electronic signature of a person authorized to act on behalf of the owner of an exclusive right that is allegedly infringed;
2. Identification of the copyrighted work claimed to be infringed or, if multiple copyrighted works are covered by a single notification, a representative list of such works;
3. Identification of the Content that is claimed to be infringing or to be the subject of infringing activity and that is to be removed or access to which is to be disabled, and the information reasonably sufficient to permit BioMarin to locate the Content;
4. Information reasonably sufficient to permit BioMarin to contact the complaining party;
5. A statement that the complaining party has a good faith belief that the use of the Content in the manner complained of is not authorized by the copyright owner, its agent, or the law;
6. A statement that the information in the notification is accurate, and under penalty of perjury, that the complaining party is authorized to act on behalf of the owner of an exclusive right that is allegedly infringed. For copyright inquiries under the Digital Millennium Copyright Act, please contact BioMarin’s Copyright Agent:
   Amber Orr
   Copyright Agent
   105 Digital Drive
   Novato, CA 94949
   Phone: (415) 506-6700
   aorr@bmrn.com

III. Web Site and Registration Administration

1. Linking
   You may provide a link to the top page of this Web site unless and until BioMarin gives notice that you must discontinue linking to this Web site.
2. Authority of Web Site Administrator
   BioMarin may in its discretion modify, edit, translate, suspend, restrict access to or terminate this Web site, these terms and conditions, the Content or any link at any time without liability or prior notice. BioMarin may in its discretion terminate the browsing of, registration with and use of this Web site by any user at any time without liability or prior notice for any reason, including for any breach of these terms and conditions.
3. Good Samaritan Policy
   It is BioMarin’s policy not to tolerate any acts of intellectual property infringement or violations of federal or state law. BioMarin will, in good faith, use commercially reasonable efforts to remove, disable, or restrict access to the availability of Content on the Web site that, in BioMarin’s subjective view, is obscene, lewd, lascivious, filthy, excessively violent, harassing, or otherwise objectionable, whether or not such material is constitutionally protected. This provision does not impose upon BioMarin any contractual obligation to undertake, or refrain from undertaking, any particular course of conduct, or to monitor the Web site. If you believe that someone has violated this policy, we ask you to promptly notify us by e-mail at the following address: abuse@pku.com.
4. Import/Export Control
   You agree not to submit any Content to this Web site or commit any act involving the transfer of information relating to any Content in violation of applicable import/export control, espionage or national security laws.

IV. User Requirements and Obligations

1. Compliance
   You agree to comply with all applicable laws in connection with your use of this Web site.
2. Unsuitable Content and Conduct
   You agree not to engage in conduct or submit to this Web site any Content or other material that is illegal, inaccurate, misleading, misappropriated, infringing, dilutive, defamatory, obscene, offensive, or otherwise objectionable. You further agree not to cause damage, embarrassment or adverse publicity to BioMarin.
3. Functional Compatibility and System Abuse
   If the Web site accepts the submission of Content, you will submit only Content and material that is functionally and technically compatible with this Web site. You will not attempt to and will not damage, corrupt, tamper with or infect this Web site, the Content or any information or telecommunication system of BioMarin with a virus, worm, Trojan Horse or other malicious computer program. You will only use this Web site for the permitted purposes stated in these terms and conditions, and will not engage in abusive activity with respect to this Web site. Without limiting the generality of the foregoing, you agree not to send, create or reply to so called “mailbombs” (i.e., e-mailing copies of a single message to many users, or sending large or multiple files or messages to a single user with malicious intent) or engage in “spamming” (i.e., unsolicited e-mailing for business or other purposes) or undertake any other activity which may adversely affect the use or enjoyment of this Web site by any person. You are prohibited from using any services or facilities provided in connection with this Web site to compromise security or tamper with system resources and/or accounts. The use or distribution of tools designed for compromising security (e.g., password guessing programs, cracking tools or network probing tools) is strictly prohibited. If you become involved in any violation of system security, BioMarin reserves the right to release your details to law enforcement authorities in order to assist them in resolving security incidents.
4. User Cooperation and Notification
   You agree to cooperate with all reasonable requests of BioMarin and will notify BioMarin promptly upon learning of your actual or suspected breach of these terms and conditions or unauthorized use or abuse of this Web site.
5. Third Party Sites and Other Information
   This Web site may contain as a convenience to you, Content, links and other information submitted by third parties over whom BioMarin has no control or responsibility. BioMarin has no obligation to monitor, control or restrict the use of this Web site, or third party Web sites accessible via links on this Web site. These other sites are not under the control of BioMarin, and you acknowledge that (whether or not such sites are affiliated in any way with BioMarin) BioMarin is not responsible for the accuracy, copyright compliance, legality, decency, or any other aspect of the content of such sites. The inclusion of such a link does not imply endorsement of any site by BioMarin or any association with its operators. Moreover, BioMarin has no obligation to verify any Content submitted by a user or to provide any registration or other information to you concerning any Content.
6. Warranty Disclaimers, Limitations on Liability and Remedies
   THIS WEB SITE, ITS CONTENT, AND ITS LINKS ARE PROVIDED ON AN “AS IS” BASIS AND ARE USED ONLY AT YOUR SOLE RISK, TO THE FULLEST EXTENT PERMISSIBLE BY LAW. BIOMARIN DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, OF ANY KIND, REGARDING THIS WEB SITE (INCLUDING ITS CONTENT, HARDWARE, SOFTWARE AND LINKS), INCLUDING ANY IMPLIED WARRANTIES AS TO FITNESS FOR A PARTICULAR PURPOSE, MERCHANTABILITY, TITLE, NON-INFRINGEMENT, RESULTS, ACCURACY, COMPLETENESS, ACCESSIBILITY, COMPATIBILITY, SECURITY AND FREEDOM FROM COMPUTER VIRUS. BIOMARIN MAKES NO REPRESENTATIONS OR WARRANTIES THAT YOUR ACCESS TO AND USE OF THE SITE (1) WILL BE UNINTERRUPTED OR ERROR-FREE OR (2) IS FREE OF VIRUSES, UNAUTHORIZED CODE, OR OTHER HARMFUL COMPONENTS. IF APPLICABLE LAW DOES NOT ALLOW THE EXCLUSION OF SOME OR ALL OF THE ABOVE IMPLIED WARRANTIES TO APPLY TO YOU, THE ABOVE EXCLUSIONS WILL APPLY TO YOU TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW.
   BIOMARIN WILL NOT BE LIABLE FOR ANY DAMAGES OR LOSSES, INCLUDING DIRECT, INDIRECT, CONSEQUENTIAL, SPECIAL, INCIDENTAL OR PUNITIVE DAMAGES AND LOST PROFITS, IN CONNECTION WITH USE OF THE INTERNET, THIS WEB SITE, ITS CONTENT, OR ITS LINKS, HOWEVER CAUSED, WHETHER IN CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, EVEN IF BIOMARIN HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. BIOMARIN WILL NOT BE A PARTY TO, AND WILL HAVE NO RESPONSIBILITY OR LIABILITY FOR, ANY TRANSACTION NEGOTIATED OR ARRANGED BY A USER ARISING IN CONNECTION WITH THIS WEB SITE. IN ANY EVENT, IF ANY OF THE ABOVE PROVISIONS IN THIS SECTION ARE NOT ENFORCEABLE IN AN APPLICABLE JURISDICTION, THE MAXIMUM LIABILITY OF BIOMARIN WILL BE LIMITED TO, IN THE SOLE DISCRETION OF BIOMARIN, EITHER THE (1) CORRECTION OR DELETION OF ANY INACCURATE CONTENT OR LINK; OR (2) REFUND OF ANY FEES FOR THIS WEB SITE RECEIVED FROM YOU BY BIOMARIN.
7. Indemnification
   You agree to defend, indemnify and hold harmless BioMarin and its affiliates, officers, directors, employees and contractors from any demands, claims, damages, liabilities, expenses or harms, including attorneys fees, arising in connection with your use of this Web site, online conduct, breach of these terms and conditions or dealings or transactions with other persons resulting from use of this Web site.
8. Interactive Areas
   You may be permitted to access and use chat rooms, bulletin boards, mail lists, customized home pages, and other forms of group electronic communications through the Site (“Interactive Areas”). If you participate in Interactive Areas you are responsible for your own communications and the consequences of posting your communications. If you choose to post material using such Interactive Areas, you agree to do so solely for lawful purposes. You expressly agree that you will not post any material that: (1) is defamatory, libelous, abusive, or obscene, including, without limitation, material which encourages conduct that would constitute a criminal offense, give rise to civil liability or otherwise violate any applicable local, state, federal, or international law; (2) infringes on the copyright or any other proprietary right of a third-party; (3) would invade the privacy of any other person; (4) is intended to advertise to or solicit others without BioMarin's express permission; (5) constitute charity solicitations, chain letters or pyramid schemes; (6) contains a virus, worm, Trojan Horse, time bomb, or any other harmful program or component; or (7) does not generally pertain to the designated topic or theme of the Site. You also expressly agree that you will not: (a) after receiving warning, continue to post material that BioMarin has advised you not to post; (b) create a false identity or forged e-mail address or header, or otherwise attempt to mislead others as to the identity of the sender or the origin of the message; (c) post, generate or disseminate so-called “spam” or mass-mailings; (d) harvest or otherwise collect information about others, including e-mail addresses, without their consent; (e) interfere with or disrupt networks connected to the Site, or used for purposes of delivering the Content or the Services (or violate the regulations, policies or procedures of such networks); (f) attempt to gain unauthorized access to restricted areas of the Site, other accounts, computer systems or networks connected to the Site, through password mining or any other means; or (g) interfere with the use and enjoyment of the Site by another Site user. BioMarin may not, and is not responsible for, screening or monitoring material posted by you or any other person or entity in Interactive Areas. If notified of any material that is alleged not to conform to these terms and conditions, BioMarin may investigate the allegation and determine in its sole discretion to remove or request the removal of the material. BioMarin reserves the right to remove material, which is abusive, illegal, disruptive, or that otherwise fails to conform to these terms and conditions. BioMarin reserves the right to edit or delete any material posted on its Site, regardless of whether such material violates these standards for content. BioMarin has no liability or responsibility to you or any other person or entity for performance or nonperformance of the screening activities set forth above. BioMarin further does not represent, warrant or guarantee the truthfulness, accuracy, or reliability of any of the material posted in Interactive Areas. BioMarin also does not endorse any opinions expressed in Interactive Areas. YOU ACKNOWLEDGE THAT ANY RELIANCE ON CONTENT POSTED IN INTERACTIVE AREAS IS AT YOUR OWN RISK. You hereby grant to BioMarin a non-exclusive, worldwide, royalty-free, perpetual license, with right to sublicense, reproduce, distribute, transmit, create derivative works of, publicly display and publicly perform any materials and other information you submit to the Interactive Areas by all means and in any media now known or hereafter developed for any use or purpose.

V. Miscellaneous

1. Separate Terms and Conditions
   In connection with your use of and/or access to Content contained in certain areas of this Web site, it may be necessary for you to consent to policies or terms and conditions in addition to these terms and conditions set forth herein, which you should read carefully before making any use of such Content or areas of this Web site. Any such terms will not vary or replace these terms and conditions regarding any use of this Web site, unless otherwise expressly stated.
2. Privacy Notice
   BioMarin is concerned about privacy and has developed a policy to address privacy concerns. You can find the current privacy notice at PRIVACY NOTICE (the “Privacy Notice”). The Privacy Notice is hereby incorporated into these terms and conditions by reference, and constitutes a part of these terms and conditions. There is also a KIDS NOTICE provided especially for minors that can be reviewed by clicking here.
3. Dispute Resolution; Applicable Law and Forum
   With respect to any and all disputes arising out of or in connection with this Web site or these terms and conditions (including without limitation the Privacy Notice), BioMarin and you agree to negotiate in good faith and undertake reasonable efforts to cooperate with one another in order to achieve a mutually satisfactory resolution. BioMarin has no obligation to become involved in any dispute between a user and any other person. This Web site, these terms and conditions and any dispute arising in connection therewith shall be exclusively governed by and construed in accordance with the laws of the State of California without regard to its conflict of law principles. BioMarin and you agree that all disputes arising under this agreement will be settled exclusively through confidential binding arbitration in San Francisco, California or another forum mutually agreed upon by the parties, pursuant to the Rules of Arbitration (“Rules”) of the International Chamber of Commerce (“ICC”) by a sole arbitrator nominated by agreement of the parties and confirmed in accordance with the said Rules. The arbitrator’s award shall be binding and may be entered as a judgment in a court of competent jurisdiction. You agree that BioMarin is entitled to obtain preliminary injunctive relief to the extent allowed by law to enforce any of the terms of these terms and conditions pending a final arbitral decision.
4. Modification of Terms and Conditions, etc
   These terms and conditions and the Privacy Notice referenced above constitute the complete agreement between you and BioMarin with respect to their subject matter and supersede any prior agreement or communication. These terms and conditions are subject to change from time to time. BioMarin will endeavor to post a notice of any changes to these terms and conditions for a period of thirty (30) days following any such modifications. Therefore, you are advised to review these terms and conditions occasionally, or at least every thirty (30) days. Your continued use of this Web site subsequent to BioMarin’s notice of modification of these terms and conditions shall constitute your acceptance of the modified terms and conditions. If any term or provision of these terms and conditions shall be found to be invalid, illegal or otherwise unenforceable, such finding shall not affect the other terms or provisions of these terms and conditions, or the whole of these terms and conditions, but such term or provision shall be deemed modified to the extent necessary to render such term or provision enforceable, and the rights and obligations of the parties shall be construed and enforced accordingly, preserving to the fullest permissible extent the intent and agreements set forth in these terms and conditions. Your obligations pursuant to these terms and conditions shall survive termination of this Web site, any use by you of this Web site, any User Content on this Web site, or these terms and conditions.
5. Medical Disclaimers
   The Content available through the Site is for informational and educational purposes only and is not a substitute for the professional judgment of a health care professional in diagnosing and treating patients. BioMarin does not give medical advice, nor does it provide medical or diagnostic services. Your reliance upon Content obtained by you at or through the Site is solely at your own risk.
6. Children (any individual under the age of 13) must Have Permission of Guardian This site is not intended or designed to attract children. We do not collect personally identifiable information from any person we actually know is a child without the permission of the parent or guardian of the child.
7. Foreign Access or Use
   BioMarin makes no claim that the site is appropriate for access or use outside the U.S. Your access and/or use of the site outside the U.S. are at your own risk, and you are responsible for compliance with the laws of your jurisdiction.
8. Contact Information
   If you have any questions regarding these Terms of Use, please contact BioMarin at service@kuvan.com or by telephone at (415) 506-6613. If you have any questions regarding this Web site, please contact the webmaster at webmaster@kuvan.com.

 

Indication

KUVAN^® (sapropterin dihydrochloride) Tablets is approved to reduce blood Phe levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). KUVAN is to be used with a Phe-restricted diet.

Important Safety Information

High blood Phe levels are toxic to the brain and can lead to lower intelligence and decrease in the ability to focus, remember and organize information. Any change you make to your diet may impact your blood Phe level. Follow your doctor’s instructions carefully. Your doctor and dietitian will continue to monitor and may adjust your diet throughout your treatment with KUVAN.

If you have a fever, or if you are sick, your Phe level may go up. Tell your doctor and dietitian as soon as possible so they can see if they have to adjust your treatment to help keep your blood Phe levels in the desired range.

KUVAN is a prescription medicine and should not be taken by people who are allergic to any of its ingredients. Tell your doctor if you have ever had liver or kidney problems, are nursing or pregnant or may become pregnant, have poor nutrition or are anorexic. Your doctor will decide if KUVAN is right for you. Tell your doctor about all the medicines you take.

The most common side effects reported when using KUVAN are headache, diarrhea, abdominal pain, upper respiratory tract infection (like a cold), throat pain, vomiting, and nausea.

To report SUSPECTED ADVERSE REACTIONS, contact BioMarin Pharmaceutical Inc. at 1-866-906-6100, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the full Patient Information by clicking here.