Terms of Use

Welcome

These Terms of Use apply to any web site operated or controlled by GTC Biotherapeutics (hereinafter collectively referred to as the "Sites"). Sites as used in this Terms of Use, "You" or "Your" refers to visitors and users of this Sites. "We", "Us" or "GTC" includes GTC Biotherapeutics, Inc. ("GTC") and its related companies, as well as any third-party vendors We hire to assist directly in the administration of these Sites.

Binding Agreement

By using the Sites and accessing information on the Sites, You acknowledge that You have read, understood and agree to be bound by the following Terms of Use and all applicable local, state and Federal laws, rules and regulations. If You do not agree to these Terms of Use, You are not permitted to use the Sites.

Special Note to Our Visitors

The Sites do NOT provide any medical advice, diagnosis, or treatment. If You need medical advice, diagnosis, or treatment, please see a physician and do NOT use the Sites for that purpose. Further, GTC does not and cannot recommend treatment or offer medical advice on personal health matters. The contents contained herein, including but not limited to all product information, is for informational purposes only and is not intended, nor should it be used, as a substitute for professional medical advice, diagnosis or treatment. GTC does not recommend or endorse any specific tests, products, procedures, opinions, or other information that may be mentioned on the Sites. The contents on these Sites shall not be used as a substitute for professional diagnosis or treatment. Further, Your access to or use of the Sites does not create in any way a physician-patient relationship, any sort of confidential relationship, or any other relationship that would give rise to any duties on the part of GTC, its agents or employees. Always seek the advice of a qualified healthcare professional with any questions You may have regarding any medical condition. Never disregard medical advice or delay in seeking medical advice because of something You have read on these Sites. If there is an emergency, dial 911.

While We make reasonable efforts to ensure the information provided on the Sites is accurate, We make no warranties about the accuracy and reliability of the information, data or content on the Sites. We shall not be responsible or liable for the accuracy, usefulness or availability of any information transmitted or made available via the Sites. Neither GTC nor any source that may provide Us with information for these Sites is directly or indirectly responsible for practicing medicine, dispensing medical services, or providing treatments as part of the Sites. These Sites are provided "AS IS" without warranty, express or implied. See the Disclaimer of Warranties Section below for more details.

Proper Use of the Sites

You agree that You will use the Sites in compliance with all applicable local, state and federal laws, rules and regulations. Violation of any of the foregoing or of these Terms of Use may result in immediate termination of these Terms of Use and may subject You to state and federal penalties and other legal consequences. We reserve the right, but shall have no obligation, to investigate Your use of the Sites in order to (a) determine whether a violation of these Terms of Use has occurred or (b) comply with any applicable law, regulation, legal process or governmental request.

You may not use the Sites in any manner that could damage, disable, overburden, or impair our servers or networks, or interfere with any other party's use and enjoyment of the Sites. You may not attempt to gain unauthorized access to any services, user accounts, computer systems or networks, through hacking, password mining or any other means. We may take any legal and technical remedies to prevent the violation of this provision and to enforce these Terms of Use.

Certain parts of the Sites may require a password to enter. You agree that You are responsible for all acts or omissions that occur on Your account while Your password is being used. If You believe someone has used Your password or account without Your authorization, You must notify us immediately. We reserve the right to access and disclose any information, including, without limitation, user names of accounts and other information, to comply with applicable laws and lawful government requests.

Privacy

We collect personal information on the Sites, which is subject to the terms of our Privacy Policy, located at www.GTC-bio.com.

We strongly advise that You do not provide Us with any personal health or related information. Any information related to Your physical condition that You voluntarily disclose via the Sites shall be disclosed at Your own risk. You understand and agree that while We are committed to protecting privacy and confidentiality of the information You disclose in accordance with Our Privacy Policy, We are unable to ensure protection from hackers, thieves, honest error, or unforeseen misconduct.

General Disclaimer

THESE SITES AND THEIR CONTENT ARE PROVIDED "AS IS," "WITH ALL FAULTS" AND "AS AVAILABLE." GTC , ITS LICENSORS, AND ITS SUPPLIERS, TO THE FULLEST EXTENT PERMITTED BY LAW, DISCLAIM ALL WARRANTIES, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OF THIRD PARTIES' RIGHTS, AND FITNESS FOR PARTICULAR PURPOSE. SPECIFICALLY, GTC, ITS LICENSORS, AND ITS SUPPLIERS MAKE NO REPRESENTATIONS OR WARRANTIES ABOUT THE ACCURACY, RELIABILITY, COMPLETENESS, CURRENTNESS, SUITABILITY OR TIMELINESS OF THE CONTENT, SOFTWARE, TEXT, GRAPHICS, TOOLS, LINKS, OR COMMUNICATIONS PROVIDED ON OR THROUGH THE USE OF THE SITES OR GTC, OR ON ANY SITE OR SITES "LINKED" TO THESE SITES. GTC MAKES NO WARRANTY THAT THE SITES WILL BE AVAILABLE, UNINTERRUPTED, NON-INFRINGING, ERROR FREE, OR FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS.

WE DO NOT ENDORSE AND ARE NOT RESPONSIBLE FOR THE ACCURACY OR RELIABILITY OF ANY OPINION, ADVICE OR STATEMENT ON THE SITES. UNDER NO CIRCUMSTANCES WILL GTC BE LIABLE FOR ANY LOSS OR DAMAGE CAUSED BY YOUR RELIANCE ON INFORMATION OBTAINED THROUGH EITHER THE CONTENT ON THE SITES OR USE OF ANY PRODUCT DESCRIBED ON THE SITES. IT IS YOUR RESPONSIBILITY TO EVALUATE THE ACCURACY, COMPLETENESS OR USEFULNESS OF ANY INFORMATION, OPINION, ADVICE OR OTHER CONTENT AVAILABLE THROUGH THE SITES. PLEASE SEEK THE ADVICE OF PROFESSIONALS, AS APPROPRIATE, REGARDING THE EVALUATION OF ANY SPECIFIC INFORMATION, OPINION, ADVICE OR OTHER CONTENT ON THE SITES.

Intellectual Property Rights & Grant

The Sites contain copyrighted material, trademarks and other proprietary information, including data, text, software, photos, video and graphics ("Content"). This Content is copyrighted, subject to registered trademarks or trade dressor otherwise protected and owned by GTC or a third party who licensed or granted to GTC the right to use such material.

GTC authorizes You to copy materials published by it on the Sites for non-commercial and internal use only. This means You may not modify, publish, transmit, display, participate in the transfer or sale, create derivative works, or in any way exploit the Content of the Sites or any portion of them. You may not use any data mining, robots, or similar data gathering and extraction tools on the Content, frame any portion of the Sites or Content, or reproduce, reprint, copy, store, publicly display, broadcast, transmit, modify, translate, port, publish, sublicense, assign, transfer, sell, loan, or otherwise distribute the Content without the prior written consent of GTC. You may not circumvent any mechanisms included in the Content for preventing the unauthorized reproduction or distribution of the Content.

In the event You make a permitted, non-commercial use of the Content, You must ensure that any such copy of the Content includes the appropriate copyright and/or other proprietary notification.

Nothing contained in these Terms of Use shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent or trademark of GTC or any third party. Except as expressly provided above, nothing contained herein shall be construed as conferring any license or right to use or exploit any copyrighted material displayed or available Sites.

Except as expressly set forth on the Sites, if You submit any information to Us, including any comments, remarks, suggestions, ideas, notes, drawings, graphics, concepts, or other information, You are giving that information, and all Your rights in it, to GTC free of charge and such information shall be deemed to be non-confidential and GTC shall have no obligation of any kind with respect to such information and shall be free to reproduce, use, disclose and distribute the information to others without limitation, without Your consent or any compensation to You or anyone else. GTC shall be free to use any know-how or techniques contained in such information for any purpose whatsoever including but not limited to developing, manufacturing and marketing products incorporating such information.

Children

The Sites are not intended for use by persons under the age of 18. By submitting information to the Sites, You have affirmed, under penalty of law, that You are at least 18 years old or older.

Links to Other Sites

The Sites may contain links or references to other websites. We do not control, nor endorse, other Sites and this Terms of Use does not apply to those websites. Under no circumstances shall We be held responsible or liable, directly or indirectly, for any loss or damage caused or alleged to have been caused to a user in connection with the use of or reliance on any content, goods or services available on such an external website. We encourage You to read the Terms of Use and Privacy Policy of every website that You visit.

Limitation of Liability

YOUR SOLE AND EXCLUSIVE REMEDY FOR ANY OTHER DISPUTE WITH US IS TO DISCONTINUE YOUR USE OF THE SITES. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL GTC, ITS LICENSORS, ITS SUPPLIERS, OR ANY THIRD PARTIES MENTIONED ON THE SITES BE LIABLE FOR ANY DAMAGES (INCLUDING, WITHOUT LIMITATION, INCIDENTAL, SPECIAL, INDIRECT AND CONSEQUENTIAL DAMAGES, PERSONAL INJURY/WRONGFUL DEATH, LOST PROFITS, OR DAMAGES RESULTING FROM LOST DATA OR BUSINESS INTERRUPTION) RESULTING FROM THE USE OR INABILITY TO USE THE SITES, RELIANCE UPON ANY STATEMENT OR INFORMATION OR CONTENT PROVIDED BY THE SITES, OR ANY FAILURE OF PERFORMANCE, ERROR, OMISSION, INTERRUPTION, EFFECT, DELAY IN OPERATION OR TRANSMISSION, COMPUTER VIRUS, LINE SYSTEM FAILURE, LOSS OF DATA, OR LOSS OF USE RELATED TO THE SITES OR ANY SITE OPERATED BY ANY THIRD PARTY, WHETHER BASED ON WARRANTY, CONTRACT, TORT, OR ANY OTHER LEGAL THEORY, AND WHETHER OR NOT GTC IS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IF YOU ARE DISSATISFIED WITH US, ANY OF OUR SERVICES OR THESE TERMS OF USE, YOUR SOLE AND EXCLUSIVE REMEDY IS TO DISCONTINUE USE OF THE SITES.

Changes to These Terms of Use

GTC may, from time to time in its sole discretion, change or modify these Terms of Use. Any changes or modification will be effective upon posting of the revisions on the Sites. At any given time, Your access and use of the Sites and provision of information is governed by the Terms of Use then in effect. Your continued use of the Sites following GTC's posting of any changes or modifications will constitute Your acceptance of such changes or modifications. Should You not wish to be bound by the modified Terms of Use; You may not use or access the Sites.

Choice of Law & International Visitors

These Terms of Use are governed by the laws of the State of Massachusetts, without resort to its conflict of laws principles. If any provision of these Terms of Use is found to be invalid by any court having competent jurisdiction, the invalidity of such provision shall not affect the validity of the remaining provisions of these Terms of Use. You expressly agree that exclusive jurisdiction for any dispute with GTC, or in any way relating to Your use of the Sites, resides in the courts of the State of Massachusetts.

The GTC Sites are intended for use by U.S. residents only. If You are a non-U.S. resident, please be aware that although the products discussed are registered worldwide, they may not be available in particular countries, or may be approved or cleared by a government regulatory body for sale or use with different indications, dosages and restrictions. Trademarks may also vary. Therefore, the most current locally approved prescribing information should always be examined carefully. The contents contained herein, including but not limited to all product information, is for informational purposes only.

Effective Date January 16, 2011

Indications and Usage

ATryn is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.

It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.

 

Important Safety Information

ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. Allergic-type hypersensitivity reactions, including anaphylaxis, are possible. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. If these symptoms occur during administration, treatment must be discontinued immediately and emergency treatment should be administered.

The anticoagulant effect of drugs that use antithrombin to exert their anticoagulation may be altered when ATryn is added or withdrawn. To avoid excessive or insufficient anticoagulation, coagulation tests suitable for the anticoagulant used (e.g., aPTT and anti-Factor Xa activity) are to be performed regularly, at close intervals, and in particular in the first hours following the start or withdrawal of ATryn. Additionally, patients should be monitored for the occurrence of bleeding or thrombosis in such situations.

The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis, and post procedural). The most common adverse events reported in clinical trials at a frequency of =5% are hemorrhage and infusion site reaction.