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Privacy Notice

Product Safety, Complaints, and Medical Inquiries

Last updated: March 27, 2023

The safety and quality of our products is paramount to TerSera Therapeutics LLC and its affiliated companies (collectively, “TerSera,” “us” or “we”). Thus, if we receive information regarding our products’ safety, efficacy, or product complaints, we pay attention. We, or third parties whom we have engaged to assist us, collect and review the information and, at times, will request additional details so that we can evaluate what, if any, action we may need to take to maintain our products’ safety, efficacy, and quality, and to ensure our continued compliance with applicable laws. Additionally, when we receive inquiries related to our products, we endeavor to respond in a timely and helpful manner.

For these activities, personal information will be collected and processed, so we have published this Privacy Notice to explain the personal information that we collect related to product safety and efficacy information, medical inquiries, and/or product complaints; how such personal information will be processed; and your rights with respect to such personal information.

For general information about how we handle personal information we collect in contexts other than product safety information and/or product complaints, please review our Privacy Policy.

Defined terms

As you read this Privacy Notice, it will be helpful if we share a common vocabulary. Thus, for purposes of this Privacy Notice, the following terms have the meanings below:

  • “authorized recipients” means service providers engaged by TerSera to assist with product pharmacovigilance and/or product complaints (“PV/PC providers”); trading partners that market, distribute, or license our products outside of the United States (“trading partners”); and healthcare authorities/regulatory agencies with jurisdiction over drug products (“healthcare authorities”).

  • “medical inquiry” means a request for medical or scientific information related to one of our products. Please note that medical inquiries related to PV/PC data might also constitute a safety event or product complaint.

  • “patient” means an individual who was administered or took our product and experienced a safety event or a product-related complaint. Please note that a patient might also be a reporter.

  • “personal information” means information related to PV/PC data or to a medical inquiry that identifies, directly or indirectly, with an individual.

  • “pharmacovigilance” or “PV” means the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem, including the processing of PV/PC data and associated personal information as described in this Privacy Notice.

  • “pharmacovigilance/product complaint data” or “PV/PC data” means information about safety events and/or product complaints.

  • “process” means any operation or set of operations which is performed on personal information or on sets of personal information, whether or not by automated means, such as collection, recording, organization, structuring, storage, adaptation or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction.

  • “product” means a product that TerSera markets or sells in the United States or abroad.

  • “reporter” means an individual who reports to us or to a regulatory agency information about (i) a safety event, or (ii) a product-related complaint. Please note that a reporter might also be a patient.

  • “requestor” means an individual who submits a medical inquiry to us. Please note that if a medical inquiry relates to PV/PC data such that the medical inquiry also constitutes a safety event or product complaint, then the requestor might also be a patient or reporter.

  • “safety event” means an adverse reaction, side effect, abnormal lab result, injury or illness, overdose, misuse, abuse, withdrawal, rebound effect, medication error, off-label use of product, lack of product efficacy, drug interaction, occupational exposure, incidental exposure to product during conception or pregnancy, exposure to product during breastfeeding, or unexpected beneficial effect experienced by a patient while taking one of our products.

  • “third parties” means service providers engaged by TerSera, including PV/PC providers, engaged by TerSera; pharmacies, hospitals, practices, or healthcare providers that interact with patients; trading partners; and healthcare authorities.

What personal information is collected/processed?

We may need to collect and process the following personal information:

  • Patient’s name or initials, demographic information (e.g., birthday/age, height and weight, biological gender, race/ethnicity), and medical history relevant to the safety event or product complaint (e.g., medical conditions/diseases, medications/treatment details, lab reports, symptoms, etc.), and identity and contact information of patient’s treating physicians/healthcare team.

  • Reporter’s name, contact information (e.g., physical address, email address, phone/fax number), profession, and relationship with the patient.

  • Requestor’s name, contact information (e.g., physical address, email address, phone/fax number), profession, and/or affiliation with the product that is the subject of the medical inquiry.

How and why personal information is collected/processed?

We collect personal information related to PV/PC data directly from patients or reporters, and indirectly from third parties that receive such personal information from patients or reporters and then share the information with us. We collect personal information related to medical inquiries directly from requestors.

We will only collect and process personal information as described in this Privacy Notice.

We collect and process personal information for the following purposes (“authorized purposes”):

  • investigate safety events or product complaints, which may include requesting additional details from patients and reporters;

  • facilitate the return of a product for which a complaint has been reported in order to investigate the root cause of the complaint and determine if any corrective action is required and, if appropriate, send replacement product;

  • create and maintain a database of PV/PC data in order to monitor for patterns or trends;

  • evaluate what, if any, action we may need to take to maintain our products’ safety and quality and to ensure our continued compliance with applicable laws;

  • comply with applicable laws, regulations, court orders, subpoenas, or other demands to which we are legally required to respond;

  • protect or defend our legal rights, or protect national security or the health or safety of patients and/or the general public;

  • provide PV/PC data, including associated personal information, and/or reports to authorized recipients in connection with any of the activities listed in the preceding bullet points;

  • respond to, and follow-up on, medical inquiries; and

  • create and maintain a database of medical inquiries and corresponding responses both for internal reference and consistency, and to document compliance with applicable laws related to medical inquiries.

We, and our trading partners, are required by law to collect, evaluate, and report to various healthcare authorities certain PV/PC data and associated personal information, and there is a substantial public interest in evaluating and maintaining the safety, efficacy and quality of our products. Additionally, to respond to medical inquiries efficiently and accurately, and to document compliance with applicable laws, we have a legitimate interest in collecting and processing the personal information of the requestor for the limited purposes described in this Privacy Notice. As such, if, and to the extent that, our collection and processing of personal information is subject to the European Union (“EU”) General Data Protection Regulation (“GDPR”), the legal basis for collecting and processing personal information is pursuant to GDPR Articles 6 and 9.

With whom personal information is shared & how it is protected

We share personal information related to PV/PC data with authorized recipients, but only for the authorized purposes listed above. We do not share personal information related to medical inquiries with any third parties other than in limited circumstances with transaction parties (defined below).

We may share personal information with potential transaction partners, service providers, advisors, and other third parties (“transaction parties”) in connection with the consideration, negotiation, or completion of a corporate transaction in which we are acquired by or merged with another company, or we sell or transfer all or a portion of our assets or business.

When personal information is collected and processed, it may be collected and processed outside the country of residence of the applicable patients and reporters, and, therefore, may be subject to different privacy laws than the laws applicable within the patients’ and/or reporters’ country of residence. However, we protect personal information from accidental loss or unauthorized access, use, alteration, or disclosure using industry-standard physical, electronic, and procedural safeguards, and we contractually require PV/PC providers, trading partners, and transaction parties to do the same, including, when applicable, by executing agreements that may be required under applicable law to safeguard personal information when it is transferred outside of the individual’s country of residence. Such safeguards include, as appropriate for the type of data and the purpose for which the data was collected, routine security assessments and improvements; privacy and data security trainings, policies, and procedures; contractual protections; physical and technical access restrictions; pseudonymization, aggregation, and/or encryption of PV data; and many others.

Personal information is retained only for so long as is necessary to fulfill the authorized purposes for which it was collected and to comply with applicable laws, at which time it will be securely deleted. At a minimum, personal information will be retained for the periods set forth below, or such longer period as may be required by applicable laws:

  • PV data and related personal information will be retained for 25 years after the date that the product is no longer marketed;

  • product complaint data and related personal information will be retained for 7 years; and

  • medical inquiry data and related personal information will be retained for 25 years.

Changes to this privacy notice

We reserve the right to amend this Privacy Notice without prior notice to reflect technological advancements, legal and regulatory changes, and good business practices. If we change this Privacy Notice, a new privacy notice will reflect those changes and the effective date of the revised privacy notice will be communicated in the revised privacy notice. We will also provide any additional notices, as required by applicable law.

Rights regarding personal information

Depending on where you live, you might have the legal right to:

  • request a copy of personal information that we retain about you;

  • request correction of inaccurate personal information;

  • request that we delete your personal information; 

  • request that we limit the processing of your personal information;

  • request to withdraw your consent for the ongoing processing of your personal information; and

  • submit a complaint to the data protection authority in the country in which you are a resident.

If you make any of the requests described above, we will honor your request to the extent required by applicable law and will make a good-faith effort to honor your request in all other cases. However, as further described in our general Privacy Policy, we may require you to verify your identity before we are able to honor your request in relation to your personal information. Additionally, because we are required by law to collect, process, and retain PV/PC data and associated personal information, we may be unable to honor requests to delete or limit the processing of your personal information to the extent that we have a legal obligation or right to process or retain such information.

If you want to exercise any of your rights, or if you have any questions about this Privacy Notice or how we collect and process personal information, please contact us by:

  • clicking on the “Contact Us” link on this website;

  • e-mailing us at legal@tersera.com; or

  • writing to us at our postal address -- Legal Department, TerSera Therapeutics LLC, 520 Lake Cook Rd, Suite 500, Deerfield, IL 60015.

Unless otherwise specified, all company and product names appearing in this Website are trademarks owned by or licensed to TerSera Therapeutics LLC, its subsidiaries or affiliates. No use of any TerSera trademark, trade name, or trade dress in this Website may be made without the prior written authorization of TerSera, except to identify the product or services of the company. 

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