You should be aware that Navidea is not a healthcare provider (e.g., doctor, hospital, or pharmacist) and therefore is generally not subject to the Privacy Rule under the Health Insurance Portability and Accountability Act (HIPAA). To the extent that HIPAA imposes requirements on healthcare providers relating to individually identifiable healthcare information, those requirements may not apply to Navidea.
COLLECTION OF INFORMATION
Information You Provide
You are not required to provide any information in order to access the Site and the information available on the Site. However, in order to take advantage of certain features offered or provided on the Site, you may be asked to provide certain types of information that may reasonably identify you, such as your name, e-mail address, mailing address or phone number. For example, we may collect such information if you choose to join our email list or send questions or comments to us via e-mail, or if you ask to receive information or an investor kit.
Automatically Collected Information
We may automatically collect certain technical information from your computer or device when you access or use the Site. That information may include your Internet Protocol address, the type of device you may use to access the Site, your browser type, your operating system, the pages you view on the Site, and the pages you view immediately before and after you access the Site. We may collect this information using “cookies,” web beacons, or similar technologies.
USE OF INFORMATION
We may also use the information we collect for a variety of purposes, including but not limited to:
- fulfilling your requests for information or services;
- responding to the communications you send via the Site;
- delivering marketing communications, special offers, or advertisements that may be of interest to you, including the delivery of targeted advertisements that are based on your previous online activities on the Sites or third-party websites;
- improving and troubleshooting the Site and our services;
- customizing the Site in accord with user expectations and interests;
- generating and analyzing statistics about how people use the Site, such as how many visitors visit a specific page on the Site, how long they stay on that page, and which hyperlinks, if any, they "click" on; and
We may combine or aggregate any of the information we collect through the Site or from other sources for any of these purposes.
Disclosure of Information
We may also disclose any of the information that we collect to third parties to the extent reasonably necessary to facilitate a contemplated or actual merger, acquisition, sale, or other transfer of all or a portion of our assets.
Navidea reserves the right to disclose information when we determine that we have reason to believe that disclosing this information is reasonably necessary to enforce our or one of our customer’s rights, or bring legal action against someone who may be causing injury to or interference with (either intentionally or unintentionally) Navidea's rights or property, other visitors, or anyone else that could be harmed by such activities. Navidea also reserves the right to disclose information to comply with legal obligations or requests, such as subpoenas or other legal process, or government reporting obligations, and when we otherwise believe in good faith that the law requires it.
We may share information that cannot reasonably be linked to a particular individual with any third party for any reason.
THIRD PARTY CONTENT
The Sites may contain links to content or integrated content (like embedded videos) provided by third parties. The information practices of those third parties may differ from ours. You should consult the privacy policies of any third party that provides content that you access through the Sites as we do not control and are not responsible for the information that they collect, use, or share. Because your web browser may obtain integrated content directly from third-party servers, the third parties may be able to collect information as if you had visited their sites directly. The third parties may use the information they collect to track your online activities over time and across various websites.
Protecting the security of your personal information is important to us. We strive to maintain reasonable administrative, technical, and physical safeguards designed to safeguard the information collected through the Site. Unfortunately, no data transmission over the Internet can be guaranteed to be 100% secure. As a result, while Navidea strives to protect your personal information and privacy, we cannot guarantee or warrant the security of any information you disclose or transmit to us online and cannot be responsible for the theft, destruction, or inadvertent disclosure of your personal information.
INFORMATION PROCESSING AND STORAGE
Information collected through the Site will be processed in and subject to the laws of the United States, which may not provide the same level protection for your personal information as your home country, and may be available to the United States government or its agencies under a lawful order made in the United States. In addition, we may transfer your information outside the United States to our affiliates, business partners, and service providers located in other countries. By using the Site, you consent to such transfer to, and processing in, the United States and these other countries.
We do not knowingly collect information from children under the age of 18 on the Site. If you are under the age of 18, do not provide any personal information to us. If you are under the age of 18 and wish to obtain information from us, we encourage you to consult with your parent or guardian.
Navidea will respect your marketing and communications preferences. You can opt-out of receiving marketing emails from us at any time by following the opt-out instructions in our emails. You can also request removal from all our contact lists, by contacting us at the email address or phone number provided below. Please note that if you request to no longer receive marketing communications from us we may continue to send you non-marketing communications, including those that we may be required by law to send to you.
You may have the option of disabling cookies using your browser preferences. Most browsers are initially set up to accept cookies. You can reset your browser to refuse all cookies or indicate when a cookie is being sent. However, please be aware that some features of the site may not function as intended if you disable cookies.
YOUR CALIFORNIA PRIVACY RIGHTS
If you reside in California and have provided personally identifiable information (as defined by California law) to us, you may request information once per calendar year about our disclosures of certain categories of your personally identifiable information to third parties for their direct marketing purposes. Such requests must be submitted to us in writing at the contact information listed below in “Contact us.”
CHANGES TO THESE TERMS
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.
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.