Lymphoseek

The information on this web site is intended for use only by healthcare professionals in the United States.

Terms of Use

WELCOME

This page describes the terms and conditions governing your use of Lymphoseek.com (the “Site”). You should assume that you may use the information that you see or read on the Site only as provided in these Terms of Use, in the text on the Site, or with the written permission of Navidea Biopharmaceuticals, Inc., its subsidiaries or affiliates (“Navidea”, “we,” “our,” or “us”). The content of this Site (“Content”) and any services provided on the Site are provided subject to the following notices, terms and conditions. By using or browsing this Site, you agree to these Terms of Use. If you do not agree, please do not use or browse this Site.

These Terms of Use incorporate by reference our Privacy Policy, located here. Our Privacy Policy explains the information we may collect, how we use and share that information, and other important information. Please read our Privacy Policy carefully as you are agreeing to it when you use the Site or otherwise agree to these Terms of Use. 

NOTICE REGARDING PRODUCT INFORMATION

The information provided on this Site is intended primarily for investors, professional healthcare providers, and persons interested in Navidea BioPharmaceuticals, Inc. The information is not intended to persuade any person(s) with regard to medical treatment of an existing or potential medical condition. Individuals should always consult with their physician before making any decisions regarding medical treatment of any physiological condition. Never disregard medical advice or delay in seeking it because of something you have read on this site or in the Content.

Navidea develops radiopharmaceutical imaging agents for use by healthcare professionals. Marketing of these agents is regulated by government agencies in each of the countries in which Navidea does business.  For example, the Food and Drug Administration regulates certain of our activities in the United States. Marketing regulations restrict information about our products that can be disclosed to the public. This Site may contain information about products that may or may not be available in certain countries; may be available under different trademarks in some countries; and may be approved or cleared for use in certain countries subject to varying indications or restrictions. Nothing contained on this Site should be construed as a promotion or solicitation for any product or for the use of any product in a way that is not authorized by the laws and regulations of the country where you are located. Specific questions about the availability and use of products described on this Site should be directed to Navidea at info@navidea.com.

INTELLECTUAL PROPERTY INFORMATION

The trademarks, tradenames, logos, service marks, trade dress and products (collectively the “Trademarks”) displayed on the Site are registered and unregistered Trademarks of Navidea or others. The Trademarks displayed on this Site may be protected in the United States and internationally.

Nothing contained on the Site should be construed as granting by implication, estoppel, or otherwise, any license or right to use any of the Trademarks displayed on the Site without the prior written permission of Navidea or any third party that may own the Trademarks displayed on the Site. Your use of the Trademarks displayed on the Site or any other content on the Site, except as provided in these Terms of Use, is strictly prohibited and may be in violation of copyright law, trademark law, the law of slander and libel, the law of privacy and publicity, and communications regulations and statutes. You are also advised that Navidea reserves the right to strictly and aggressively enforce its intellectual property rights to the fullest extent of the law, including the seeking of criminal prosecution.

The entire contents of this Site—including, but not limited to, images and text—are subject to copyright protection. You may not copy the contents of the Site other than for noncommercial individual reference with all copyright or other proprietary notices retained.  Except as expressly provided in these Terms, via specific language on the Site, or by our prior, express, written consent, you may not copy, display, download, distribute, modify, reproduce, republish or retransmit any information, images, text, or documents contained in this Site or any portion thereof in any electronic medium or in hard copy, or create any derivative work based on such content. Nothing contained in the Site or 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 Navidea or any third party.

USER SUBMISSIONS

Any information, ideas, or concepts provided by you to the Site is provided on a non-confidential basis. If you submit information via Site, you agree that we may use any information or materials you submit without limitation and you grant us a royalty-free, perpetual, irrevocable, worldwide nonexclusive license to use, reproduce, create derivative works from, modify, publish, edit, translate, distribute, perform, and display the information in any media, form, format, or forum. You also agree that you will not upload or transmit any information that (a) infringes or violates applicable law or the rights of any party; (b) contains a virus or any malicious code; or (c), as determined in our sole discretion, contains, harmful, profane, obscene, pornographic or otherwise offensive material or information.

Although Navidea may from time to time monitor or review e-mails, discussions, postings, transmissions, and similar user content on the Site, Navidea is under no obligation to do so and assumes no responsibility or liability arising from any such content nor for any error, defamation, libel, slander, omission, falsehood, obscenity, pornography, profanity, danger, or inaccuracy contained in any information provided by users on the Site. Navidea reserves the right, but has no corresponding obligation, to remove any content at our discretion and to fully cooperate with any law enforcement authorities or court order requesting or directing Navidea to disclose the identity of anyone posting any such information or materials.

GUIDELINES FOR LINKING TO THIS SITE

Linking to the Site indicates that you accept our Terms of Use and legal restrictions and that you will abide by the below guidelines.  If you do not accept these conditions, do not link to the Site. 

If you link to the Site, you agree that you:

  • May link to, but not replicate, Site content;
  • Shall not frame or otherwise create a browser or border environment around Site content;
  • Shall not imply that Navidea is endorsing you or your products or services;
  • Shall not misrepresent your or your site’s relationship with Navidea;
  • Shall not present false, misleading or inaccurate information about Navidea or Navidea’s products on your site or otherwise disparage Navidea’s products;
  • Shall not use Navidea’s logos without our express prior written permission;
  • Shall not include content on your site that is or could be construed as illegal, distasteful, offensive or controversial and shall include on your site only content that is appropriate for all age groups;
  • Shall not link to an internal page of this Site that is located one or several levels down from the home page or bring up or present content of this Site on another site without Navidea’s prior written permission; and
  • Will comply with all applicable laws, rules, and regulations.

DISCLAIMER OF WARRANTIES

Your use of this Site is at your own risk. This Site and all of the information it contains is provided for informational purposes only.

Without limiting the foregoing, everything on the Site is provided to you “AS IS” WITHOUT WARRANTY OF ANY KIND. TO THE FULLEST EXTENT PERMISSIBLE PURSUANT TO APPLICABLE LAW, NAVIDEA DISCLAIMS ALL WARRANTIES, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NONINFRINGEMENT.  NAVIDEA MAKES NO REPRESENTATIONS OR WARRANTIES ABOUT THE ACCURACY, RELIABILITY, AVAILABILITY, COMPLETENESS, CURRENTNESS, SUITABILITY, OR TIMELINESS OF THE SITE OR ANY PART THEREOF. 

Please note that some jurisdictions may not allow the exclusion of implied warranties, so some of the above exclusions may not apply to you.

LIMITATION OF LIABILITY

NEITHER NAVIDEA, ANY OF ITS AGENTS, NOR ANY OTHER PARTY INVOLVED IN CREATING, PRODUCING, OR DELIVERING THE SITE WILL BE LIABLE FOR ANY DIRECT, INCIDENTAL, CONSEQUENTIAL, INDIRECT, OR PUNITIVE DAMAGES ARISING OUT OF YOUR ACCESS TO, USE OF, RELIANCE ON, OR INABILITY TO USE THE SITE, THE MATERIALS IN THIS SITE, OR THE MATERIALS IN ANY SITE LINKED TO THIS SITE.

Navidea also assumes no responsibility, and shall not be liable for any damages that you may incur as a result of a virus, worm, or other harmful code that may be transmitted to your computer equipment or other property on account of your access to, use of, browsing the Site, or your downloading of any materials, data, text, images, video, or audio from the Site.

Some states or jurisdictions do not allow the exclusion or limitation of liability for certain damages. Some of the above limitations may therefore not apply to you. To the extent that applicable law does not permit any of these exclusions or limitations of liability, our liability is limited to the extent permitted under applicable law.

INDEMNITY

In exchange for accessing or using this Site, you agree to indemnify, defend, and hold harmless Navidea and its officers, directors, employees, agents, suppliers, and third party partners from (i) your use of and access to the Site; (ii) your violation of these Terms of Use; and (iii) your violation of any third-party rights, including any copyright, trademark, trade secret, or privacy rights related to any information submitted by you via the Site. This defense and indemnification obligation will survive the availability and your use of the Site.

DISPUTE RESOLUTION

You and we agree that in the event of any disputes between us, we will first try to resolve it by talking with each other. If we are unsuccessful in resolving our disputes in this manner within a reasonable time period, we agree that any claims arising in connection with your use of the Site or any part thereof must be brought within one year of the date of the event giving rise to such a claim.

These Terms of Use are governed by the internal substantive laws of the State of Ohio, 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 Navidea, or in any way relating to your use of this site, resides in the courts of the State of Ohio.

INFORMATION FOR INVESTORS REGARDING FORWARD-LOOKING STATEMENTS

Statements made on this Site that relate to any subject other than strictly historical facts, such as statements about Navidea’s plans and strategies, expectations for future financial performance, new and existing products and technologies, and markets for Navidea’s products, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date they are made. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, Navidea’s limited revenues, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and exclusive distributor, uncertainty of market acceptance, competition, limited marketing and manufacturing experience, and other risks detailed in Navidea’s most recent Annual Report on Form 10-KSB and other Securities and Exchange Commission filings. Navidea undertakes no obligation to publicly update or revise any forward-looking statements.

MISCELLANEOUS

These Terms of Use represent the complete agreement between you and us concerning the Site.

This Site may provide links or references to other sites but the owners of this Site have no responsibility for the content of such other sites and shall not be liable for any damages or injury arising from that content. Inclusion of any third party link does not imply an endorsement or recommendation by Navidea.

You agree to use the Site only for lawful purposes. You agree not to take any action that might compromise the security of the Site, render the Site inaccessible to others or otherwise cause damage to the Site or the Content. You agree not to add to, subtract from, or otherwise modify the Content, or to attempt to access any Content that is not intended for you. You agree not to use the Site in any manner that might interfere with the rights of third parties.

This Site is intended to be accessed only from the United States. If you access the Site from outside the United States, you do so at your own risk and are responsible for compliance with applicable laws. We do not claim that the Site complies with the laws of jurisdictions outside the United States.

Navidea may terminate your access to all or part of the Site at any time and without notice if we believe, in our sole discretion, that you may have breached these Terms of Use. 

Our failure to exercise or enforce any right or provision of these Terms of Use shall not constitute a waiver of such right or provision.

The section titles in these Terms of Use are for convenience only and have no legal or contractual effect.

UPDATES TO THE SITE AND TERMS

Navidea may make improvements and/or changes to this Site at any time. Although we attempt to periodically update information on this Site, the information, materials and services provided on or through this Site may occasionally be inaccurate, incomplete or out of date. Navidea does not have a duty to update information contained in this Site, and Navidea will not be liable for any failure to update such information. We undertake no obligation to update or revise the information contained on this Site, whether as a result of new information, future events or circumstances or otherwise. It is your responsibility to verify any information contained in this Site before relying upon it. All rights reserved.

Navidea may also at any time revise these Terms of Use by updating this posting. Your use of the Site indicates your acceptance of the then current Terms of Use. 

Contact information

If you have any questions about the Site or these Terms of Use, please contact us at:

Navidea Biopharmaceuticals 
5600 Blazer Parkway, 
Suite 200, 
Dublin, OH  43017

(p) 614-793-7500
(f) 614-793-7522
Toll Free (US) - 800-793-0079

info@navidea.com

These Terms were last revised on December 11, 2014.

Copyright © 2014 Navidea BioPharmaceuticals, Inc. All rights reserved.

*Indication

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

  • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
  • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.

In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

Please see full Prescribing Information.

To report suspected adverse reactions, contact Navidea Biopharmaceuticals, Inc. at 1-800-476-5270 or FDA at 1 800-FDA-1088 or www.fda.gov/medwatch.