Legal Statement

Introduction

This page states the Terms and Conditions under which you may use www.serostim.com (the “Web Site”). Please read this page carefully. If you do not accept these Terms and conditions, do not use this Web Site. By using this Web Site, you are indicating your acceptance to be bound by these Terms and Conditions. EMD Serono may revise these Terms and Conditions at any time by posting an update to this page. You should visit this page periodically, because your continued use of the Web Site following the posting of changes to these Terms and Conditions will mean you accept those changes. The terms “you” and “user” as used herein refer to all individuals and/or entities accessing the Web Site for any reason.

 

Use of Material

The site contains information intended for U.S. residents only. Products described may or may not be available in other countries or regions of the world, may be available under different trademarks in different countries and, where applicable, may be approved or cleared by a government regulatory body for sale or use with different indications and restrictions in different countries.

The contents of this Web Site, such as text, graphics, images, and other material (“Material”), are owned by EMD Serono and its licensors and vendors, and are protected by United States and foreign intellectual property laws. Unauthorized use of the Material may violate copyright, trademark, and other laws.

EMD Serono authorizes you to view and download a single copy of the material on the Web Site solely for your personal use, provided you retain all copyright and other proprietary notices contained in the original Material on any copy you make of the Material. You may not sell or modify the Material or reproduce, display, publicly perform, distribute, or otherwise use the Material in any way for any public or commercial purpose. The use of the Material on any other website or in a networked computer environment for any purpose is prohibited.

You may not copy or adapt the HTML or other code that EMD Serono uses to generate its pages. This code is also protected by EMD Serono’s copyright.

 

Acceptable Site Use

General Rules: You may not use the Web Site in order to transmit, distribute, store, or destroy material (a) in violation of any applicable law or regulation; (b) in a manner that will infringe the copyright, trademark, trade secret, or other intellectual property rights of others or violate the privacy, publicity, or other personal rights of others; or (c) that is defamatory, obscene, threatening, abusive, or hateful.

Security Rules: You are prohibited from violating or attempting to violate the security of the Web Site and from using the Web Site to violate the security of other websites by any method, including, without limitation: (a) accessing data not intended for you or logging into a server or account that you are not authorized to access; (b) attempting to probe, scan, or test the vulnerability of a system or network or to breach security or authentication measurers without proper authorization; (c) attempting to interfere with service to any user of the Web Site, host or network, including, without limitation, via means of submitting a virus to the Web Site, overloading, “flooding,” “spamming,” “mailbombing,” or “crashing”; (d) sending unsolicited e-mail, including promotions and/or advertising of products or services; or (e) forging any EMD Serono packet header or any part of the header information in any e-mail or newsgroup posting. Violations of system or network security may result in civil or criminal liability. EMD Serono may investigate violations of these Terms and Conditions and may involve and cooperate with law enforcement authorities in prosecuting users of the Web Site who are involved in such violations.

Specific Prohibited Uses: EMD Serono specifically prohibits any use of the Web Site, and you agree not to use the Web Site, for any of the following: distributing or otherwise publishing, without EMD Serono’s approval, any material containing any solicitation of funds, promotion, advertising, or solicitation for goods or services; soliciting other users of the Web Site to join or become members of any commercial online service; or deleting or revising any material posted by any other person or entity.

 

EMD Serono’s Liability

The Material may contain inaccuracies or typographical errors. EMD Serono makes no representations about the accuracy, reliability, completeness, or timeliness of the Web Site or the Material. The use of the Web Site and the Material is at your own risk. We reserve the right, at our discretion, to modify, add, or remove portions of the Web Site at any time without notice.

You acknowledge and agree that you are solely responsible for the form, content, and accuracy of any material placed by you on the Web Site.

EMD SERONO DOES NOT WARRANT THAT THE WEB SITE WILL OPERATE ERROR-FREE OR THAT THE WEB SITE AND ITS SERVER ARE FREE OF COMPUTER VIRUSES OR OTHER HARMFUL MECHANISMS. IF YOUR USE OF THE WEB SITE OR THE MATERIAL RESULTS IN THE NEED FOR SERVICING OR REPLACING EQUIPMENT OR DATA, EMD SERONO IS NOT RESPONSIBLE FOR THOSE COSTS.

THE WEB SITE AND MATERIAL ARE PROVIDED ON AN “AS IS” BASIS WITHOUT ANY WARRANTIES OF ANY KIND. EMD SERONO, TO THE FULLEST EXTENT PERMITTED BY LAW, DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING THE WARRANTY OF MERCHANTABILITY, FITNESS FOR PARTICULAR PURPOSE, AND NON-INFRINGEMENT. EMD SERONO MAKES NO WARRANTIES ABOUT THE ACCURACY, RELIABILITY, COMPLETENESS, OR TIMELINESS OF THE MATERIAL, SERVICES, SOFTWARE, TEXT, GRAPHICS, OR LINKS.

 

Disclaimer of Consequential Damages

IN NO EVENT WILL EMD SERONO, ITS SUPPLIERS, OR ANY THIRD PARTIES MENTIONED ON THE WEB SITE BE LIABLE FOR ANY DAMAGES WHATSOEVER (INCLUDING, WITHOUT LIMITATION, INCIDENTAL, RELIANCE OR CONSEQUENTIAL DAMAGES, LOST PROFITS, OR DAMAGES RESULTING FROM LOST DATA OR BUSINESS INTERRUPTION) RESULTING FROM THE USE OR INABILITY TO USE THE WEB SITE OR THE MATERIAL, WHETHER BASED ON WARRANTY, CONTRACT, TORT, OR ANY OTHER LEGAL THEORY, AND WHETHER OR NOT EMD SERONO IS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

Links to Other Sites

The Web Site may contain links to third-party websites. These links are provided solely as a convenience to you and not as an endorsement by EMD Serono of the contents on such third-party web sites. EMD Serono is not responsible for the content of linked third-party sites and does not make any representations regarding the content or accuracy of materials on such third-party sites. If you decide to access linked third-party sites, you do so at your own risk.

EMD Serono cannot ensure that you will be satisfied with any products or services that you purchase from a third-party site that links to or from EMD Serono, because these sites are owned and operated by independent retailers. EMD Serono does not endorse any of the merchandise, nor has EMD Serono taken any steps to confirm the accuracy or reliability of any of the information contained in such third-party sites. EMD Serono does not make any representations or warranties as to the security of any information (including, without limitation, credit card and other personal information) you might be requested to give any third party, and you hereby irrevocably waive any claim against us with respect to such sites. We strongly encourage you to make whatever investigation you feel necessary or appropriate before proceeding with any online or off-line transaction with any of these third parties.

 

Limitation of Liability

The aggregate liability of EMD Serono to you for all claims arising from the use of the Materials is limited to $100.

 

Termination

EMD Serono reserves the right, at its sole discretion, to immediately terminate your ability to access the Web Site and/or any other service provided to you by EMD Serono, upon any breach by you of these Terms and Conditions.

 

Indemnity

You agree to defend, indemnify, and hold harmless EMD Serono, its officers, directors, employees, and agents, from and against any claims, actions, or demands, including without limitation reasonable legal and accounting fees, alleging or resulting from your use of the Material or your breach of the terms of these Terms and Conditions. EMD Serono will provide notice to you promptly of any such claim, suit, or proceeding and will assist you, at your expense, in defending any such claim, suit, or proceeding.

 

General

EMD Serono makes no claims that the Materials may be lawfully viewed or downloaded outside of the United States. Access to the Materials may not be legal by certain persons or in certain countries. If you access the Web Site from outside of the United States, you do so at your own risk and are responsible for compliance with the laws of your jurisdiction. These Terms and Conditions are governed by the internal substantive laws of the Commonwealth of Massachusetts, without respect to its conflict of laws principles. Jurisdiction of any claims arising under these Terms and Conditions will lie exclusively with the state or federal courts within Boston, Massachusetts. If any provision of these Terms and Conditions is found to be invalid by any court having competent jurisdiction, the invalidity of such provision will not affect the validity of the remaining provisions of these Terms and Conditions, which will remain in full force and effect. No waiver of any provision of these Terms and Conditions will be deemed a further or continuing waiver of such provision or any other provision. Except as expressly provided in an end user software license, or in a “Legal Notice” or other statement by EMD Serono on the Web Site, these Terms and Conditions constitute the entire agreement between you and EMD Serono with respect to the use of the Web Site. No changes to these Terms and Conditions may be made except by a revised posting on this page.

INDICATION AND IMPORTANT RISK INFORMATION

You should not take SEROSTIM if you have:

  • A critical illness from surgery, serious injuries, or a severe breathing problem
  • Cancer or undergoing treatment for cancer
  • Eye problems caused by diabetes
  • Allergies to growth hormone

What should I tell my doctor before using SEROSTIM?

  • If you have cancer or had cancer in the past.
  • If you have diabetes, are at risk for getting diabetes, or have blood sugar levels that are higher than normal. New cases of type 2 diabetes have been reported in patients taking Serostim.
  • If you are allergic to growth hormone, or other ingredients such as benzyl alcohol, sucrose, phosphoric acid, sodium hydroxide, or metacresol
  • If you are taking any other medicines (both prescription or over the counter), vitamins, or supplements because these medicines may affect each other. Your doctor may need to adjust the dose of Serostim or other medicines you are taking.
  • If you are nursing, pregnant, or plan to become pregnant. It is not known if Serostim passes into your breast milk or could harm your unborn baby.

What are the most common side effects of SEROSTIM reported in clinical trials in patients treated for HIV-associated wasting or cachexia?

  • Swelling, especially in the hands or feet
  • Bone, muscle, and joint pain or stiffness
  • Tingling and numbness
  • Unusual skin sensations
  • Breast enlargement in men
  • Nausea
  • Extreme tiredness

Other less common but serious side effects of SEROSTIM are:

  • Tumors or cancerous growths
  • High blood sugar (hyperglycemia/diabetes) which can include symptoms of increased thirst and urination, tiredness, or trouble concentrating
  • Headaches, changes in vision, nausea or vomiting, which requires immediate medical attention
  • Serious allergic reactions that require immediate medical attention
  • Numbness and tingling in the hand or arm caused by a pinched nerve in the wrist
  • Injection site reactions (such as pain, numbness, redness, and swelling)
  • Pain and tenderness in the abdomen, which could be a sign of a problem with the pancreas

These are not all of the possible side effects. Let your doctor know about any side effects you experience.

How should you administer Serostim?

Patients and caregivers should be trained by a healthcare professional on how to mix and inject Serostim prior to use. Never share Serostim with another person, even if the needle is changed.

What is SEROSTIM® (somatropin) for injection?

Serostim is an injectable prescription medicine used for the treatment of HIV-positive patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Treatment with antiretroviral therapy at the same time is necessary.


Please see the Prescribing Information for a complete list of Serostim Risk Information.