Effective Date: October 1, 2018
For more information on how BioMarin processes your personal information, and your rights regarding your personal information, please see our Privacy Notice.
You may not access or use, or attempt to access or use, the Services to take any action that could harm us or any third party, interfere with the operation of the Services, or in a manner that violates any law(s). For example, and without limitation, you may not:
Violations of system or network security may result in civil or criminal liability. We may investigate and work with law enforcement authorities to prosecute users who violate the Terms. We may suspend or terminate your access to the Services for any or no reason at any time without notice.
The Services and any information or content provided therein are for informational and educational purposes only and are 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 any content or information provided through the Services is solely at your own risk.
You remain fully responsible for the materials that you provide to us, including, without limitation, information, stories, requests, creative works, pictures, photographs, letters, documents, demos, ideas, suggestions, reviews, concepts, methods, systems, designs, plans, techniques, or other materials submitted, posted, uploaded, sent, or otherwise transmitted to us (“User Content”). You agree not to provide User Content that:
You may only post User Content that is original and that you have the right to post. By submitting User Content, you grant us a royalty-free, irrevocable, perpetual, non-exclusive, worldwide, fully sublicensable license to publish, reproduce, distribute, display, perform, edit, adapt, modify, translate, create derivative works from, make, sell, export, and otherwise use your User Content (or any portion thereof) in any way that we want and in any form, media, or technology now known or later developed. You hereby waive any moral rights you may have in your User Content. You represent that you have obtained all necessary permissions, including the right to use an individual’s likeness in our advertising and marketing activities, from any individuals identified in or implicated by your submission (including those shown in photographic content), and, in the case of minors, also from their parents or legal guardians, as appropriate.
We are not obligated to publish or use your User Content. BioMarin is not in any manner endorsing the User Content and cannot, and will not, vouch for its reliability. We do not guarantee any confidentiality with respect to any User Content. Please do not send us any confidential or proprietary information or material.
BioMarin is not responsible for any User Content and has no duty to monitor the User Content posted on the Services. You use any information contained in User Content at your own risk.
BioMarin and its designees have the right, in their sole discretion, to monitor, review, edit, remove, delete, disable, refuse, restrict, or terminate access to your User Content or the Services (in whole or in part) at any time, without prior notice and in our sole discretion, for any or no reason. The obligations that you have to us under these Terms shall survive termination of the Services, any use by you of the Services, any User Content on the Services, or these Terms. You will not continue to post any User Content that BioMarin has previously advised you not to post.
You may be asked to register for certain activities in connection with the Services by creating a user profile. This registration may allow you to participate in interactive features of the Services, such as forums or discussion boards or to enter sweepstakes and contests. When you register, you agree to provide accurate, current, and complete information about yourself as requested or directed on the Services and to promptly update this information to maintain its accuracy. BioMarin has the right to suspend or terminate any account or other registration and to refuse any and all current or future use of the Services if it suspects that such information is inaccurate or incomplete. You are responsible for maintaining the confidentiality of any password and username that you are given or select in connection with the Services, and you are responsible for all activities that occur under your password or account.
The Services are protected under the copyright, trademark, and other intellectual property laws of the United States and other countries. All intellectual property rights in the Services are owned by us or our third-party licensors to the full extent permitted under U.S. and international intellectual property laws. Except for content that you have posted on the Services, you may not publish, reproduce, distribute, display, perform, edit, adapt, modify, or otherwise exploit any part of the Services, including the BioMarin name and logo, without our written consent. You may provide a link to the top page of the Services unless and until BioMarin gives notice that you must discontinue linking to the Services.
We respect intellectual property rights. If you believe in good faith that your work has been reproduced or is accessible on the Services in a way that constitutes copyright infringement, please provide our designated agent with the following information in writing:
BioMarin’s designated agent for notice of claims of alleged copyright infringement is:
105 Digital Drive
Novato, CA 94949
Phone: (415) 506-6700
If you believe that a user of the Services is a repeat infringer, please contact BioMarin’s designated agent, as described above, and provide enough information for us to verify that the individual is a repeat infringer. Please note that United States law provides significant penalties for falsely submitting a notice of copyright infringement.
The Services may contain links to third-party content. We do not control, endorse, sponsor, recommend, or otherwise accept responsibility for such content. Use of any linked third-party content is at the user’s own risk.
YOUR USE OF THE SERVICES IS AT YOUR OWN RISK. WE MAKE NO REPRESENTATIONS OR WARRANTIES ABOUT THE OPERATION OF THE SERVCES OR THE INFORMATION, MATERIALS, GOODS, OR SERVICES APPEARING OR OFFERED ON THE SERVICES, ALL OF WHICH ARE PROVIDED “AS IS.”
WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, WE DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY (1) WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE; (2) WARRANTIES AGAINST INFRINGEMENT OF ANY THIRD-PARTY INTELLECTUAL PROPERTY OR PROPRIETARY RIGHTS; (3) WARRANTIES RELATING TO THE TRANSMISSION OR DELIVERY OF THE SERVICES; (4) WARRANTIES RELATING TO THE ACCURACY, RELIABILITY, CORRECTNESS, OR COMPLETENESS OF DATA MADE AVAILABLE ON THE SERVICES OR OTHERWISE BY BIOMARIN; (5) WARRANTIES OTHERWISE RELATING TO PERFORMANCE, NONPERFORMANCE, OR OTHER ACTS OR OMISSIONS BY BIOMARIN OR ANY THIRD PARTY; AND (6) WARRANTY OF TITLE. FURTHER, THERE IS NO WARRANTY THAT THE SERVICES WILL MEET YOUR NEEDS OR REQUIREMENTS OR THE NEEDS OR REQUIREMENTS OF ANY OTHER PERSON.
WE MAKE NO WARRANTIES, EXPRESS OR IMPLIED, (1) THAT THE SERVICES OR ANY EMAIL WE SEND YOU IS FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS THAT MAY INFECT YOUR COMPUTER EQUIPMENT OR OTHER PROPERTY BECAUSE OF YOUR ACCESS TO, USE OF, OR BROWSING ON THE SERVICES OR YOUR DOWNLOADING OF ANY MATERIALS, DATA, TEXT, IMAGES, VIDEO, OR AUDIO FROM THE SERVICES; OR (2) THAT THE SERVICE, WEBSITE CONTENT, FUNCTIONS, OR MATERIALS CONTAINED THEREIN WILL BE TIMELY, SECURE, ACCURATE, COMPLETE, UP-TO-DATE, OR UNINTERRUPTED. BIOMARIN DOES NOT NECESSARILY ENDORSE, SUPPORT, SANCTION, ENCOURAGE, OR AGREE WITH ANY WEBSITE CONTENT OR ANY SUBMITTED MATERIALS, AND WE EXPRESSLY DISCLAIM ANY AND ALL LIABILITY IN CONNECTION WITH USER CONTENT, INCLUDING LINKS TO OR CONTENT CONTAINED ON THIRD-PARTY WEB SITES.
IF APPLICABLE LAW DOES NOT ALLOW THE EXCLUSION OF SOME OR ALL OF THE ABOVE WARRANTIES TO APPLY TO YOU, THE ABOVE EXCLUSIONS WILL APPLY TO YOU TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW.
UNDER NO CIRCUMSTANCES, INCLUDING NEGLIGENCE, WILL BIOMARIN, ITS AFFILIATES, OR ANY PARTY INVOLVED IN CREATING, PRODUCING, OR DELIVERING THE SERVICES BE LIABLE FOR DAMAGES OR LOSSES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INCIDENTAL, CONSEQUENTIAL, INDIRECT, SPECIAL, OR PUNITIVE DAMAGES AND LOST PROFITS, ARISING OUT OF YOUR ACCESS, USE, MISUSE, OR INABILITY TO USE THE SERVICES, WEBSITE CONTENT, USER CONTENT, OR ANY LINKED SITES, HOWEVER CAUSED, WHETHER IN CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, OR OTHERWISE, EVEN IF BIOMARIN HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, OR IN CONNECTION WITH ANY FAILURE OF PERFORMANCE, ERROR, OMISSION, INTERRUPTION, DEFECT, DELAY IN OPERATION OR TRANSMISSION, COMPUTER VIRUS, OR LINE OR SYSTEM FAILURE. 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 THE SERVICES. IN THE EVENT THAT YOU HAVE A DISPUTE WITH ANOTHER USER RELATED TO, ARISING FROM, OR IN ANY WAY CONNECTED WITH USE OF THE SERVICES, YOU RELEASE BIOMARIN FROM ANY CLAIMS, DEMANDS, AND DAMAGES OF EVERY KIND AND NATURE ARISING OUT OF OR IN ANY WAY CONNECTED WITH SUCH A DISPUTE. BIOMARIN HAS NO OBLIGATION TO BECOME INVOLVED IN ANY DISPUTE BETWEEN A USER AND ANY OTHER PERSON.
THESE LIMITATIONS APPLY WHETHER THE ALLEGED LIABILITY IS BASED ON CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, OR ANY OTHER BASIS, EVEN IF BIOMARIN HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. BECAUSE SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, BIOMARIN’S LIABILITY IN SUCH JURISDICTIONS SHALL BE LIMITED TO THE EXTENT PERMITTED BY LAW. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, BIOMARIN DISCLAIMS ALL LIABILITY OF ANY KIND ARISING FROM THE UNAUTHORIZED ACCESS TO OR USE OF YOUR INFORMATION.
IF YOU ARE DISSATISFIED WITH THE SERVICES, YOUR SOLE REMEDY IS TO STOP USING THE SERVICES.
You agree to defend, indemnify, and hold harmless BioMarin and its affiliates, subsidiaries, parent companies, successors, officers, directors, employees, contractors, services providers, and agents from and against any and all demands, claims, damages, liabilities, judgments, losses, costs, expenses, and harms, including, but not limited to, reasonable attorneys’ fees, arising in connection with your use of the Services (including, without limitation, your User Content), online conduct, any violation of these Terms, or dealings or transactions with other persons resulting from use of the Services.
These Terms are governed by, and must be construed in accordance with, the laws of the United States and the State of California, as applicable, without giving effect to their principles of conflicts of law. By using the Services, you waive any claims that may arise under the laws of other countries or territories.
With respect to any and all disputes arising out of or in connection with the Services or these Terms (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. If you and BioMarin do not resolve any dispute by informal negotiation, any other effort to resolve the dispute will be conducted exclusively by binding arbitration as described in this section. You are giving up the right to litigate (or participate in as a party or class member) all disputes in court before a judge or jury. Instead, all disputes will be resolved before a neutral arbitrator, whose decision will be final except for a limited right of appeal under the Federal Arbitration Act. Any court with jurisdiction over the parties may enforce the arbitrator’s award.
Any proceedings to resolve or litigate any dispute in any forum will be conducted solely on an individual basis. Neither you nor BioMarin will seek to have any dispute heard as a class action or in any other proceeding in which either party acts or proposes to act in a representative capacity. No arbitration or proceeding will be combined with another without the prior written consent of all parties to all affected arbitrations or proceedings.
BioMarin and you agree that all disputes arising under these Terms that cannot be settled through informal negotiation 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 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 pending a final arbitral decision.
To the extent permitted by law, any claim or dispute under this agreement must be filed within one year in an arbitration proceeding. The one-year period begins when the claim or notice of dispute first could be filed. If a claim or dispute isn’t filed within one year, it is permanently barred.
If any other provision of this section is found to be illegal or unenforceable, that provision will be severed, with the remainder of this section remaining in full force and effect.
In connection with your use of the Services, you may be asked to consent to policies or terms and conditions in addition to these Terms. Please read these supplemental policies and terms carefully before making any use of such portions of the Services. Any supplemental terms will not vary or replace these Terms regarding any use of the Services, unless otherwise expressly stated.
BioMarin makes no claim that the Services are appropriate for access or use outside the U.S. Your access and use of the Services outside the U.S. are at your own risk, and you are responsible for compliance with the laws of your jurisdiction.
These Terms constitute the entire agreement between BioMarin and you, superseding any prior or contemporaneous communications and proposals (whether oral, written or electronic) between you and us. In the event any provision of these Terms is held unenforceable, it will not affect the validity or enforceability of the remaining provisions and will be replaced by an enforceable provision that comes closest to the intention underlying the unenforceable provision. You agree that no joint venture, partnership, employment, or agency relationship exists between you and BioMarin as a result of these Terms or your access to and use of the Services.
Our failure to enforce any provisions of these Terms or respond to a violation by any party does not waive our right to subsequently enforce any terms or conditions of the Terms or respond to any violations. Nothing contained in these Terms is in derogation of our right to comply with governmental, court, and law enforcement requests or requirements relating to your use of the Services or information provided to or gathered by us with respect to such use.
If you believe that someone has violated these Terms, if you have questions regarding these terms, or if you have questions regarding the Services, please notify us by completing the form found here or by telephone at (415) 506-6700.
IMPORTANT SAFETY INFORMATION
Life-threatening anaphylactic reactions and severe allergic reactions have been observed in some patients during NAGLAZYME infusions and up to 24 hours after infusion. If these reactions occur, immediate discontinuation of NAGLAZYME is recommended and appropriate medical treatment should be initiated, which may include resuscitation, epinephrine, administering additional antihistamines, antipyretics or corticosteroids. In patients who have experienced anaphylaxis or other severe allergic reactions during infusion with NAGLAZYME, caution should be exercised upon rechallenge; appropriately trained personnel and equipment for emergency resuscitation (including epinephrine) should be available during infusions.
As with other enzyme replacement therapies, immune-mediated reactions, including membranous glomerulonephritis have been observed. In clinical trials, nearly all patients developed antibodies as a result of treatment with NAGLAZYME; however, the analysis revealed no consistent predictive relationship between total antibody titer, neutralizing or IgE antibodies, and infusion-associated reactions, urinary glycosaminoglycan (GAG) levels, or endurance measures.
Caution should be exercised when administering NAGLAZYME to patients susceptible to fluid volume overload because congestive heart failure may result. Consider a decreased total infusion volume and infusion rate when administering NAGLAZYME to these patients.
Consideration to delay NAGLAZYME infusion should be given when treating patients who present with an acute febrile or respiratory illness. Sleep apnea is common in MPS VI patients and antihistamine pretreatment may increase the risk of apneic episodes. Evaluation of airway patency should be considered prior to the initiation of treatment. Patients using supplemental oxygen or continuous positive airway pressure (CPAP) during sleep should have these treatments readily available during infusion in the event of an infusion reaction, or extreme drowsiness/sleep induced by antihistamine use.
Pretreatment with antihistamines with or without antipyretics is recommended prior to the start of infusion to reduce the risk of infusion reactions. If infusion reactions occur, decreasing the infusion rate, temporarily stopping the infusion, or administering additional antihistamines and/or antipyretics is recommended.
During infusion, serious adverse reactions included laryngeal edema, apnea, pyrexia, urticaria, respiratory distress, angioedema, and anaphylactoid reaction; severe adverse reactions included urticaria, chest pain, rash, abdominal pain, dyspnea, apnea, laryngeal edema, and conjunctivitis. The most common adverse events (≥10%) observed in clinical trials in patients treated with NAGLAZYME were rash, pain, urticaria, pyrexia, pruritus, chills, headache, nausea, vomiting, abdominal pain and dyspnea. The most common adverse reactions requiring interventions are infusion-related reactions.
Spinal/cervical cord compression is a known and serious complication that is expected to occur during the natural course of MPS VI. Signs and symptoms of spinal/cervical cord compression include back pain, paralysis of limbs below the level of compression, and urinary or fecal incontinence. Patients should be evaluated for spinal/cervical cord compression prior to initiation of NAGLAZYME to establish a baseline and risk profile. Patients treated with NAGLAZYME should be regularly monitored for the development or progression of spinal/cervical cord compression and be given appropriate clinical care.
Please see full Prescribing Information.
NAGLAZYME® (galsulfase) is indicated for patients with mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity.