Latigo Bio Clinical Trial Privacy Notice
Effective on: 2026-08-26
1. Introduction and Scope
Latigo Biotherapeutics, Inc. (“Latigo Bio”, “we”, “us”, “our”) sponsors ethically approved clinical trials (“Trial” or “Trials”). We take the protection of personally identifiable information (“Personal Data”) very seriously. This Clinical Trial Privacy Notice (this “Notice”) addresses individual Trial participants (“Participants”) and Trial personnel (“Personnel”) (individually and together, “you,” “your”) whose Personal Data we may receive in connection with the Trials.
Please read this Notice to learn what we are doing with your Personal Data, how we protect it, and how you can exercise your privacy rights.
This Notice does not apply to Personal Data collected by any other means, like Personal Data collected through our public website. This Notice does not apply to our job candidates, employees, or contractors. If we do not process information in a manner that identifies, relates to, describes, is reasonably capable of being associated with, or could be reasonably linked, directly or indirectly, with a particular individual, such information is not considered Personal Data and this Notice will not apply to our processing of that information.
2. Controllership
Within the scope of this Notice, Latigo Bio generally acts as a data controller for the Personal Data processed in the context of the Trials we sponsor. This means that we alone determine the purpose and means of the processing of your Personal Data.
In some jurisdictions, we are considered a “joint controller” with another organization, such as the study site where the Trial is being conducted. This means that we jointly, together with the other organization, determine the purpose and means of the processing of your Personal Data. If you would like to know more about any other data controllers who might be joint controllers together with Latigo Bio, you may ask your study doctor or the study site for further details, specifically relating to the Trial that you are participating in.
3. Categories of Personal Data
Participants:
Even though we are a data controller for the Personal Data processed in the context of our Trials, Latigo Bio itself does not receive your identifiable Personal Data, meaning that we are unable to identify you personally from the information we receive. Personal Data is collected by our service providers like the study site (the clinic or other healthcare facility where the Trial is being run) or other third parties, such as your doctors or our clinical research organizations. When any information relating to you is shared with us by our service providers, it will first be key-coded (also known as “pseudonymized”) so that we cannot identify you by any direct personal identifier (such as your name, national identification number, address, or telephone number).
The following types of Personal Data may be processed in the context of our Trials:
- basic identifying information, such as your first and last name;
- demographic information, such as your ethnicity, race, age and sex;
- contact information, such as your phone number, physical address and email address;
- location information, such as the location of your testing site and Trial location (i.e. study site);
- healthcare information, such as the identity and contact information of your doctors and healthcare providers;
- health information, such as your medical history, current health status and reaction to the Trial drug or treatment;
- your genetic information; and
- identifiers and device information.
Personnel:
The following types of Personal Data may be processed in the context of our Trials:
- basic identifying information, such as your first and last name;
- professional information, such as your place of practice, job title, the medical field in which you are active, professional qualifications and scientific activities;
- financial data, such as payment-related information; and
- location information, such as the location of your testing site and Trial location (i.e. study site).
4. How We Receive Personal Data
Participants:
We may receive your Personal Data when:
- you provide it directly to us (including when you provide your Personal Data to one of our service providers acting on our behalf);
- a study doctor (also known as an “investigator”) or other healthcare personnel at the study site provides it to us, or your healthcare provider provides it to us;
- we receive it from the clinical research organization that conducts the Trial on our behalf; and
- you provide it to us, the clinical research organization, or a study doctor when you complete a pre-screening questionnaire to confirm your eligibility to participate in the Trial.
Personnel:
We receive your Personal Data when:
- you provide it to us, to the clinical research organization, or to our service providers in your role as Personnel in the context of assisting in the conduct of the Trial.
5. Purpose of Processing
Participants:
We may process your Personal Data for the purposes of:
- managing and facilitating the Trial;
- enabling your participation in the Trial;
- answering the research questions for the Trial and aggregating data to generate statistics relating to the Trial and/or study drug or health treatment;
- arranging for the delivery of drugs to you and collection of unused drugs from you in relation to the Trial;
- arranging your transportation to or from the study site;
- sending you reminders about your appointments at the study site, or to take your medication on time;
- monitoring and reporting on any adverse events, such as negative side effects;
- developing new medicinal drugs or health treatments;
- complying with legislation governing Trials;
- disclosing your Personal Data to the appropriate regulatory authorities, auditors, and ethics committees, if required by law;
- responding to your inquiries and requests; and
- communicating with you on the status of the Trial.
We also process your Personal Data for the specific purposes described in the informed consent form provided to you by Trial Personnel.
Personnel:
We may process your Personal Data for the purposes of:
- managing our relationship with you;
- contacting Personnel for planning and organizing the Trials;
- conducting the Trials; and
- complying with applicable laws and regulations.
6. Basis of Processing
We must have a valid reason to use your Personal Data. This is called a “lawful basis for processing.”
Participants:
- We process your Personal Data for safety and reliability purposes in order to comply with our legal obligations.
- We process your Personal Data based on your consent or for scientific research purposes based on our legitimate interest in conducting clinical trials and performing valuable scientific and medical research.
- If we process your Personal Data for other purposes after the end of a Trial, we will do so based on your consent or our legitimate interest in conducting further research.
Latigo Bio will need to process data about your health in order for you to participate in a Trial. Health data is considered sensitive Personal Data (also known as a “special category” of Personal Data), and the EU General Data Protection Regulation (“GDPR”) requires that we must have an additional ground to process this type of information. Latigo Bio may process your special categories of Personal Data on the basis of your explicit consent, or where the processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes.
The specific grounds on which we process your Personal Data, including your health data, may vary somewhat from the above in order to comply with the requirements of applicable local laws in jurisdictions where we sponsor Trials.
Personnel:
- Latigo Bio may process your Personal Data based on our legitimate interests in facilitating the operation of our business and conducting Trials, making informed investigator and Trial staff selection decisions, and improving our principal investigator and Trial staff recruiting and contracting processes.
- We also process Personal Data because it is necessary for the performance of the contracts between Latigo Bio and study sites, including by enabling us to communicate with you and other principal investigators about the performance of the relevant Trial.
- Latigo Bio may process Personal Data of Trial personnel in order to comply with applicable laws and regulations, including clinical trial regulations requiring us and those acting on our behalf to collect Personal Data from individuals who participate in the conduct of a Trial.
- Personal Data may also be processed based on your consent.
7. Automated Decision-Making
If you participate in a Trial, you will be assigned a unique patient identification number. This number may be used as part of an automatic process that randomly determines the order in which you will receive the experimental drug treatment that is being evaluated in the Trial and the placebo treatment. This type of automated decision-making is required in order to ensure that the Trial is conducted in an ethical way, and in accordance with good clinical practice standards.
8. Data Retention
Participants:
We will retain your Personal Data to the maximum extent permitted by law, once your data has been key-coded and recorded in official Trial documents, we cannot remove it without affecting the accuracy of the studies and test results. For example, European law and good clinical practice standards require us to keep Personal Data that is part of the clinical trial master file for at least twenty-five (25) years after the conclusion of the applicable Trial. Other laws may require different retention periods. This includes your identity and health information and any adverse effects of the drug you took during the Trial.
Personnel:
We will retain your Personal Data until we fulfil the purposes listed above, or for as long as we are required to keep it to comply with applicable laws or regulations.
9. Sharing Personal Data with Third Parties
We may share Personal Data with service providers who process Personal Data on our behalf, and who agree to use the Personal Data only to assist us in fulfilling the purposes of processing, or as required by law. Our service providers include parties providing:
- contract/clinical research organization services;
- patient recruitment services;
- quality assurance, safety and pharmacovigilance software and related services;
- data storage and archiving software and related services;
- data analytics and reporting software and services;
- services related to the collection, storage, testing, and transportation of biological material;
- software that randomly decides which treatment you will receive during the Trial;
- logistics and transport service providers; and
- electronic data capture software and hardware.
We will also share your Personal Data with other third parties involved in the Trials. Some of these third parties are data controllers in their own right. These third parties include clinical sites like hospitals and medical offices, and public government agencies (i.e., National Health Authorities, Regulatory Authorities and Ethics Committees) and may be located in other countries.
10. International Transfers of Personal Data
Some of the abovementioned third parties may be located in countries outside of the country in which you are located. We will only transfer your Personal Data to third parties in countries which are recognized as providing an adequate level of protection for Personal Data, or which provide appropriate safeguards to protect your Personal Data. For transfers of Personal Data to a third country with no adequacy decision outside the European Economic Area (EEA), we use safeguards like the European Union Standard Contractual Clauses. To access these model clauses, please contact our Data Protection Officer (“DPO”).
11. Other Disclosure of Your Personal Data
We may disclose your Personal Data:
- with regulators or competent authorities, to the extent necessary to comply with applicable laws, regulations and rules (including, without limitation, federal, state or local laws);
- to the extent required by law, or if we have a good-faith belief that we need to disclose it in order to comply with official investigations or legal proceedings (whether initiated by governmental/law enforcement officials, or private parties);
- if, in the future, we sell or transfer, or consider selling or transferring, part or all of our company, business, shares or assets to a third party, and we disclose your Personal Data to such third party in connection with the sale or transfer; or
- in the event that we are acquired by, or merged with, a third-party entity, or in the event of bankruptcy or a comparable event, we reserve the right to transfer, disclose or assign your Personal Data in connection with the foregoing events.
If we have to disclose your Personal Data to governmental or law enforcement officials, we may not be able to ensure that those officials will maintain the privacy and security of your Personal Data.
12. Data Integrity and Security
We have implemented and will maintain technical, administrative, and physical measures that are reasonably designed to help protect Personal Data from unauthorized processing. These measures include the use of measures like key-coding and encryption, where appropriate.
13. Your Privacy Rights
You have specific rights regarding your Personal Data that we collect and process. In this section, we first describe those rights and then we explain how you can exercise them.
Right to Know What Happens to Your Personal Data
This is called the right to be informed. It means that you have the right to obtain from us all information regarding our data processing activities that concern you, such as how we collect and use your Personal Data, how long we will keep it, and who it will be shared with, among other things.
We are informing you of how we process your Personal Data with this Notice.
Right to Know What Personal Data Latigo Bio Has About You
This is called the right of access. This right allows you to ask for full details of the Personal Data we hold about you. You have the right to obtain from us, including confirmation of whether or not we process Personal Data concerning you, and, where that is the case, a copy or access to the Personal Data and certain related information.
Under some circumstances, we may deny your access request. In that event, we will respond to you with the reason for the denial.
Right to Change Your Personal Data
This is called the right to rectification. It gives you the right to ask us to correct without undue delay anything that you think is wrong with the Personal Data we have on file about you, and to complete any incomplete Personal Data.
Right to Delete Your Personal Data
This is called the right to erasure, right to deletion, or the right to be forgotten. This right means you can ask for your Personal Data to be deleted. Sometimes we can delete your information, but other times it is not possible for either technical or legal reasons. If that is the case, we will consider if we can limit how we use it. We will also inform you of our reason for denying your deletion request.
Right to Ask Us to Limit How We Process Your Personal Data
This is called the right to restrict processing. It is the right to ask us to only use or store your Personal Data for certain purposes. You have this right in certain instances, such as where you believe the data is inaccurate or the processing activity is unlawful.
Right to Ask Us to Stop Using Your Personal Data
This is called the right to object. This is your right to tell us to stop using your Personal Data. You have this right where we rely on a legitimate interest of ours (or of a third party). We will stop processing the relevant Personal Data unless: (i) we have compelling legitimate grounds for the processing that override your interests, rights, or freedoms; or (ii) we need to continue processing your Personal Data to establish, exercise, or defend a legal claim.
Right to Port or Move Your Personal Data
This is called the right to data portability. It is the right to ask for and receive a portable copy of your Personal Data that you have given us or that we have generated in connection with a Trial. Where applicable, we will provide your Personal Data in a structured, commonly used, and machine-readable format. When you request this information electronically, we will provide you a copy in electronic format.
Right Related to Automated Decision-Making
For decisions that may seriously impact you, you have the right not to be subject to automated decision-making, including profiling. In such cases, we will always explain the purposes behind the use of automated decision-making and how it affects you.
Right to Withdraw Your Consent
Where we rely on your consent as the legal basis for processing your Personal Data, you may withdraw your consent at any time. However, this will not affect the lawfulness of our processing before you withdrew your consent. It will also not affect processing performed on other lawful grounds. If you withdraw your consent, you may be ineligible to participate in the Trial.
How to Exercise Your Rights
Participants:
To exercise your rights, please first speak with your study doctor instead of contacting us directly, so that we can ensure that your confidentiality is preserved. Where appropriate, your doctor will pass on your request to Latigo Bio.
In order to correctly respond to your privacy rights requests, the study doctor will need to confirm that YOU made the request. Consequently, they may require additional information to confirm that you are who you say you are.
The study doctor will request the minimum amount of information from you required to verify your request and will only request information that is already held pertaining to you. Any Personal Data you provide related to the request will be used only in order to verify your identity or authority to make the request.
If you are unable to exercise your rights through your study doctor for any reason, you may contact our DPO, VeraSafe, by sending an email to experts@verasafe.com, or by using the information in the “Contact Us” section below. In order to preserve your confidentiality, please do not contact Latigo Bio directly.
Personnel:
You may contact our DPO, VeraSafe, by sending an email to experts@verasafe.com, or by using the information in the “Contact Us” section below.
In order to correctly respond to your privacy rights requests, the DPO will need to confirm that YOU made the request. Consequently, they may require additional information to confirm that you are who you say you are.
The DPO will request the minimum amount of information from you required to verify your request and will only request information that is already held pertaining to you. Any Personal Data you provide related to the request will be used only in order to verify your identity or authority to make the request.
Participants and Personnel:
You also have the right to lodge a complaint with a data protection regulator in your applicable jurisdiction.
14. Privacy of Children
Our Trials are generally not directed at children under the age of 18. However, where this is the case, we obtain parental or legal guardian consent before processing Personal Data about children.
15. Contact Us
If you are a Participant and have any questions about this Notice or our processing of your Personal Data, please contact your study doctor. If you are Personnel and have any questions about this Notice or our processing of your Personal Data, please contact our DPO at the contact information provided below. Our DPO will respond to you as soon as possible, but no later than one month after you contact us. If we need more time (up to 3 months in total), we will inform you of the reason why and the extension period in writing.
Latigo Bio
Latigo Bio can be contacted as follows:
Latigo Biotherapeutics
1300 Rancho Conejo Blvd, Suite 305
Thousand Oaks, CA 91320
Email: privacy@latigobio.com
Data Protection Officer
We have appointed VeraSafe as our DPO. Personnel, please contact VeraSafe on matters related to our use of your Personal Data. VeraSafe’s contact details are:
VeraSafe
100 M Street S.E., Suite 600
Washington, D.C. 20003
Email: experts@verasafe.com
Web: https://www.verasafe.com/about-verasafe/contact-us/
Tel: +1 617 398 7067
European Union Representative
We have appointed VeraSafe as our representative in the EU for data protection matters. To contact VeraSafe, please use this contact form: https://www.verasafe.com/privacy-services/contact-article-27-representative/ or use the contact details provided below:
VeraSafe Ireland Ltd.
Unit 3D North Point House
North Point Business Park
New Mallow Road
Cork T23 AT2P
Ireland
16. Changes to this Notice
If we change this Notice, we will publish the revised Notice on our website. We will also update the “Effective” date.