CELLDEX THERAPEUTICS, INC.
Effective as of September 27, 2016
What Information We Collect; the Purpose of Collection and Use
We collect the following categories of information.
Contact Information: We now or in the future may collect contact information on our Site from visitors who wish to obtain information, scientific publications, subscribe to our email alerts and contact us with questions. Contact information is provided via browser forms and may include first name, last name, e-mail address, job title, name of the organization, country, state/region and phone numbers (fax, cell and/or landline), and other information necessary for us to properly respond. This contact information is used by our public relations, investor relations, service and product teams to contact our Site visitors, and to compile and deliver our response.
Clinical Trial Information: Celldex conducts research studies under the jurisdiction of the U.S. Food and Drug Administration (“FDA”) and other equivalent foreign regulatory authorities regarding the effectiveness and safety of our Products (“clinical trials”). Your participation in a clinical trial is completely voluntary, and requires that you expressly consent in writing to the scope of the research to be conducted using the information gathered from and about you during the clinical trial of our Products (“Clinical Trial Information”) which may include, but is not limited to, your medical history, disease state, information regarding biological specimens and tissue samples, and adverse events. The form and substance of your consent must conform to applicable law. We may receive Clinical Trial Information from third parties such as contract research organizations and clinical sites. We use your Clinical Trial Information for the general research purposes for which it was originally collected and for research that is consistent with your original consent, or to which you have subsequently consented.
Key-Coded Data. Researchers use uniquely key-coded Clinical Trial Information so as not to reveal the identity of the individual data subject, and then retain the unique key code. When the unique key code is held only by the researcher and not given to Celldex, then a transfer of such Clinical Trial Information from the European Economic Area to the United States does not constitute a transfer of personal data and is not subject to the Privacy Shield.
Operations. We also collect Site health diagnostics, and technical logging information
Cookies. Cookies are small packets of data that a website stores on your computer’s hard drive so that your computer will “remember” information about your visits to our Site and other sites as described under “Google Analytics,” above. If you do not want us, Google Analytics or the Site to place a cookie on your hard drive, you may be able to turn that feature off on your device. Please consult your Internet browser’s documentation for information on how to do this, such as by using your browser in private mode to block cookies. However, if you decide not to accept cookies from our Site, the Site may not function properly.
Aggregate Data. In an ongoing effort to better understand our users and the Site, we might analyze your information in aggregate form to operate, maintain, manage, and improve the Site. This aggregate information does not identify you personally. We may share this aggregate data with our affiliates, agents, and business partners. We may also disclose aggregated user statistics in order to describe our Products and the Site to current and prospective business partners and to other third parties for other lawful purposes.
Opt-In to Certain Onward Transfers.
We will not transfer your personal information to a third party acting as a controller without first providing you with information regarding the identity of such controller or the nature of such controller’s business, and obtaining your opt-in consent. You may grant such consent by emailing us at CelldexPrivacy@celldex.com.
We will not disclose your sensitive personal information to any third party without first obtaining your opt-in consent. You may have granted such consent when you agreed to participate in a clinical trial of our Product. If you have not yet granted such consent, you may do so by emailing us at CelldexPrivacy@celldex.com.
In each instance, please allow us a reasonable time to process your response.
Disclosure to Public Authorities. We are required to disclose personal information in response to lawful requests by public authorities, including for the purpose of meeting national security or law enforcement requirements. We may also disclose personal information to other third parties when compelled to do so by government authorities or required by law or regulation including, but not limited to, in response to court orders and subpoenas.
Disclosure to Regulatory Authorities and Researchers. We may disclose your Clinical Trial Information to government regulators in the United States and equivalent foreign regulatory authorities for regulatory and supervision purposes. We may also disclose your Clinical Trial Information to public and/or private researchers, consistent with the principles of notice and choice set forth under “Clinical Trial Information” above.
Opt-Out for Direct Marketing; Email Management. You may opt out at any time from the use of your personal information for direct marketing purposes, and/or the transfer of your personal information to third parties for direct marketing purposes, by emailing us at CelldexPrivacy@celldex.com. Please allow us a reasonable time to process your request.
You may also manage your receipt of marketing and non-transactional communications by clicking on the “Manage Email Preferences” link located on the bottom of any Celldex marketing email and following the instructions found on the page to which the link takes you. You cannot opt out of receiving transactional e-mails related to your requests for information or materials.
If you are participating in a “blinded” clinical trial for one of our Products, then we must decline your request to access your Clinical Trial Information during the trial, provided that this restriction was explained to you when you entered the trial and the disclosure of such information would jeopardize the integrity of the research effort. Following the conclusion or other termination of the blinded clinical trial and analysis of the results, you may have access to your Clinical Trial Information upon request. We recommend that you first request your Clinical Trial Information directly from your health care provider in the clinical trial and secondarily from us.
If you withdraw, or are asked to withdraw, from a clinical trial of our Products, your Clinical Trial Information collected previously to your withdrawal may still be processed along with other data collected as part of the clinical trial, if this was made clear to you in the notice at the time you consented to participate in the clinical trial.
Important Notice to All Non-U.S. Residents. Our servers may be located outside of the U.S. and the European Economic Area. If you are located outside of the U.S., please be aware that any information provided to us, including personal information, will be transferred from your country of origin. Except in the case of data transfers under the EU-U.S. Privacy Shield and the U.S.-Swiss Safe Harbor Framework, your decision to provide such data to us, or allow us to collect such data through our Site, constitutes your consent to this data transfer.
Celldex is subject to the investigatory and enforcement powers of the Federal Trade Commission.
Celldex has further committed to refer unresolved privacy complaints under the U.S.-Swiss Safe Harbor to an independent dispute resolution mechanism operated by the Council of Better Business Bureaus. If you do not receive timely acknowledgment of your complaint, or if your complaint is not satisfactorily addressed, please visit www.bbb.org/us/safe-harbor-complaints for more information and to file a complaint.
Product Safety and Efficacy Monitoring. As a pharmaceutical company, Celldex does not have to apply the Privacy Shield Principles with respect to the Notice, Choice, Accountability for Onward Transfer, and Access Principles in its product safety and efficacy monitoring activities, including the reporting of adverse events and the tracking of patients/subjects using certain medicines or medical devices, to the extent that adherence to the Privacy Shield Principles interferes with compliance with regulatory requirements. This is true both with respect to reports by, for example, health care providers to pharmaceutical companies, and with respect to reports by pharmaceutical companies to government agencies like the FDA.
California Privacy Rights. Pursuant to Section 1798.83 of the California Civil Code, residents of California have the right to obtain certain information about the types of personal information that companies with whom they have an established business relationship (and that are not otherwise exempt) have shared with third parties for direct marketing purposes during the preceding calendar year, including the names and addresses of those third parties, and examples of the types of services or products marketed by those third parties. If you wish to submit a request pursuant to Section 1798.83, please contact Celldex via email at CelldexPrivacy@celldex.com. Celldex does not monitor, recognize, or honor any opt-out or do not track mechanisms, including general web browser “Do Not Track” settings and/or signals.
E-mail us at CelldexPrivacy@celldex.com.