TERMS AND CONDITIONS OF UBG REGULATORY ADVISORS

Introduction

This document describes the terms, conditions, privacy policies, and personal data processing policy (the "TERMS AND CONDITIONS") that shall apply to USERS who access via the internet the content and services provided by UBG REGULATORY ADVISORS ("UBG") on one or more of the websites owned and operated by UBG: www.ubg.com.ec; www.ubg.global; www.farmacovigilancia.com.ec; www.farmacovigilancia.ec; www.tecnovigilancia.com.ec; www.tecnovigilancia.ec; (the "SITES").

Accessing, visiting, providing personal information, using, or browsing the SITES implies that the USER:

• Has read, understands, and fully and unreservedly accepts each of the TERMS AND CONDITIONS set forth in this document;
• Agrees to use the Sites in good faith and without violating applicable laws.

If you do not agree with the TERMS AND CONDITIONS, do not continue using the SITES.

General terms of use

UBG reserves the right to limit or disallow access to the SITES at any time without any notice. UBG reserves the right to deny access to the SITES if the USER engages in acts that, in UBG's sole judgment, are considered abusive, unlawful, or that contravene the TERMS AND CONDITIONS or applicable laws. Such denial shall not give rise to any liability of UBG to the USER or to third parties.

UBG reserves the right to discontinue the SITES and the services offered thereon without prior notice and without this representing any liability of any kind for UBG.

UBG reserves the right to modify the SITES and/or the TERMS AND CONDITIONS without prior notice; such modifications shall take effect at the time they are published on the SITES. It is the USER's responsibility to carefully review the TERMS AND CONDITIONS each time they access the SITES. Each USER may print the TERMS AND CONDITIONS for future reference.

Use of the SITES or of any of their components implies express acceptance of these TERMS AND CONDITIONS. UBG maintains a corporate web portal and several information systems to provide USERS with information about the activities it performs. In some cases, statistical data will be freely accessible to facilitate their use.

By accessing or using the SITES you accept that UBG will collect, systematize, store, and process the personal data provided by THE USER through forms, as well as data concerning their browsing and behavior within the SITES.

By entering your personal data or the personal data of a third party on the SITES, you accept that you are legally authorized to provide this information and you expressly authorize UBG to collect, systematize, store, transfer, and/or transmit such data to third parties, which may be natural persons, legal entities, or government entities located in Ecuador or in other countries, for the purpose of optimizing the operation of the SITES and of carrying out Pharmacovigilance, Technovigilance, and other Sanitary Regulatory Affairs activities. Information submitted by USERS shall be hosted in a database owned by UBG and, under no circumstances, shall it be transferred for UBG's commercial purposes.

Owner of the SITES and the USERS

The owner and operator of the SITES is Ulbagar Consultoría y Representaciones Cía. Ltda., a company established in Ecuador with RUC number 1792494621001, with registered address at Mariana de Jesús E7-8 y La Pradera, edificio Bussines Plus La Pradera, Oficina 605, email: info@ubg.com.ec

The SITES are intended for use by persons over 18 years of age (the "USERS"). Use of the SITES by minors is not permitted.

Purpose of the SITES

The SITES seek to offer USERS an explanation of UBG as a company, the services it offers, articles of interest, and tools to submit one or more reports to UBG's Pharmacovigilance and Technovigilance Unit relating to personal data, health data, product-use data, and/or the occurrence of possible Adverse Events during the administration and use of certain Medicinal Products and certain Medical/Dental Devices (the "REPORTS").

The listing of Medicinal Products and Medical/Dental Devices (the "PRODUCTS") that will be available to USERS of the SITES and that may be involved in the occurrence of a possible Adverse Event shall be defined and updated exclusively by UBG in accordance with its own internal policies. UBG does not guarantee the inclusion of any specific PRODUCT in the listing. UBG shall process the data received in the REPORTS under the TERMS AND CONDITIONS.

Sections

The SITES offer the following sections:

• Header: Where UBG logos and colors, contact channels, and a brief explanation of the purpose of the SITES are displayed.
• Approval section: Where USERS must carefully read and accept the TERMS AND CONDITIONS.
• Information section: Users may learn about UBG's characteristics and the services offered.
• Forms section: Where the USER will find a series of dynamic fields to complete in order to generate a report or submit a résumé. These fields accept a limited number of alphanumeric characters, sufficient to provide an adequate amount of information. Fields marked with an asterisk are mandatory. Forms may also include drop-down lists relating to the PRODUCTS that may be reported or other information.
• Submission section: The USER must accept the submission of information, confirm the accuracy of the data, and accept the processing of personal data.

The submission of information by USERS, as well as the use of any section of the SITES, is entirely voluntary. UBG shall not at any time provide any USER who accesses or uses the SITES any prize, gift, value, or benefit in money, in kind, or of any other type for the use of the SITES.

Reports or information submitted through the SITES do not replace the reports, complaints, or any other form of information delivery to the competent Authorities to which USERS are legally obligated.

UBG does not guarantee that USERS will receive any benefit as a consequence of accessing and using the SITES or of submitting REPORTS.

Submission of REPORTS

A REPORT consists of the USER completing the information in the form section and submitting it on the SITE.

A user may submit REPORTS if the following requirements are met:

• The USER freely decides to access and use the SITES and the services offered. The USER decides to complete a form and submit the information contained therein.
• The USER completes all of the information requested in the form, especially that marked with an asterisk, as it is mandatory due to its importance for Pharmacovigilance, Technovigilance, and other Sanitary Regulatory Affairs activities. Once the USER has correctly completed the form, the USER must use the SITES' tool to accept the use of personal data and submit the information.
• The USER has read, understood, and accepted the TERMS AND CONDITIONS.
• The USER is of legal age.

Although UBG has standard technological means for receiving information through the SITES' form, UBG does not guarantee the correct receipt of the information or the processing of such data, as contingencies beyond UBG's control may occur between the submission of the form and its arrival at UBG's computer servers.

Availability of the SITES

The SITES and the services offered thereon are presented as they have been prepared. UBG does not warrant or assume any commitment arising from the content or services offered on the SITES.

To access and use the SITES, the USER must have, at a minimum, a stable internet connection, a laptop or desktop computer, tablet, smartphone, or any other device that supports an Internet connection. The connection device must support the use of internet browsers and the entry of alphanumeric characters with a physical or touch keyboard.

Access to and use of the SITES is permitted on a temporary basis. UBG reserves the right to withdraw or modify access to the SITES on a temporary or permanent basis without prior notice and without this giving rise to any liability for UBG.

The USER is responsible for complying with, and ensuring that any person who accesses the SITES through devices owned or used by the USER complies with, the TERMS AND CONDITIONS.

Prohibitions

The USER warrants the correct and lawful access to and use of the SITES and undertakes to use the site in good faith. The USER warrants that the information provided in the SITES' forms is truthful and verifiable.

The USER undertakes to:

• Use the SITE in accordance with the TERMS AND CONDITIONS and comply with applicable local, national, or international law or regulation;
• Not use the SITE in an illegal or fraudulent manner;
• In no way use the SITE to send false information or information that is contrary to good morals.
• In no way attempt to access or access without authorization our servers, programming, IT structure, systems, or third-party networks.
• In no way use the SITE by means of robots or any other type of automation that simulates being human.
• In no way copy, reproduce, extract, or use in any form the programming codes, content, logos, fonts, distinctive signs, colors, and any other characteristic or content of the SITES.
• Not damage, disable, modify, or impair the electronic channels to which the USER has access, nor the content incorporated or stored therein.
• Not use modified system versions for the purpose of obtaining unauthorized access to any electronic channel, content, and/or services offered.
• Not interfere with or interrupt access to, functionality of, and use of electronic channels and networks connected thereto.
• Give notice in the event of any issue with access to UBG's web services.

Personal data processing policy

At UBG REGULATORY ADVISORS, we recognize the importance of protecting the personal data of our clients, employees, and other members of the community. Accordingly, we are committed to ensuring the proper processing of personal data in accordance with Ecuador's Organic Law on Personal Data Protection and other applicable regulations. The processing of personal data by UBG REGULATORY ADVISORS shall be carried out in accordance with the principles and rights set forth in the Organic Law on Personal Data Protection.

I. Principles

Lawfulness: Personal data shall be processed in a lawful and legitimate manner, with the data subject's consent or in cases provided for by law.

Purpose: Personal data shall be collected for a specific, explicit, and legitimate purpose, and shall not be processed in a manner incompatible with that purpose.

Proportionality: The collection and processing of personal data shall be adequate, relevant, and limited to what is necessary to fulfill the established purpose.

Quality: Personal data shall be accurate, up to date, and relevant to the established purpose.

Security: Appropriate technical and organizational security measures shall be applied to protect personal data against unauthorized access, loss, alteration, or destruction.

Confidentiality: Personal data shall be processed confidentially, maintaining their secrecy.

II. Rights of data subjects

Right of access: To access and know the personal data that UBG REGULATORY ADVISORS processes.

Right of rectification: To request the correction or updating of inaccurate or incomplete personal data.

Right of erasure: To request the deletion of personal data when they are no longer necessary for the established purpose or the processing is unlawful.

Right to object: To object to the processing of personal data if it affects their fundamental rights and freedoms.

Right to restriction: To request the restriction of the processing of personal data in certain circumstances.

Right to data portability: To receive personal data in a structured, commonly used, and machine-readable format, and to transmit them to another controller if so desired.

Right to withdraw consent: To withdraw consent for the processing of personal data at any time, without affecting the lawfulness of processing carried out previously.

III. Processing of personal data

III.1. Collection

UBG REGULATORY ADVISORS shall use the personal data of its clients and employees, as well as of other members of the community, exclusively for commercial and administrative purposes, in compliance with applicable law. Personal data shall be collected in a transparent manner and always with the express consent of the person to whom they belong.

III.2. Use

UBG REGULATORY ADVISORS shall use the personal data of its clients and employees and other members of the community solely for the purposes established at the time of collection and always within the legal framework. Security measures shall be taken to ensure that personal data are not altered, disclosed, or deleted without authorization.

III.3. Rights of data subjects

UBG REGULATORY ADVISORS shall respect the rights of data subjects, including the right to know, rectify, update, erase, and withdraw consent for the use of their personal data.

III.4. Transfer

UBG REGULATORY ADVISORS shall share personal data with third parties with the explicit consent of the data subjects, except where required by law, by a competent authority, or where another legal basis provided for by law applies.

III.5. Security

UBG REGULATORY ADVISORS shall take appropriate technical and organizational security measures to protect the personal data of its clients and employees, including measures against unauthorized access, loss, destruction, or alteration of personal data.

III.6. Accountability

UBG REGULATORY ADVISORS shall appoint a person responsible for personal data protection and shall ensure that staff are aware of the personal data protection policy and of its importance.

III.7. Changes to the personal data protection policy

UBG REGULATORY ADVISORS reserves the right to amend this personal data protection policy at any time. If significant changes are made to the policy, data subjects shall be informed in a timely manner and their consent for the changes shall be requested.

III.8. Scope

The Personal Data Processing Policy applies to all personal data entered on the SITES and in the information systems administered by UBG REGULATORY ADVISORS.

Data required by UBG

Access to UBG's website is free; however, UBG may request the following personal data to access the applications that are restricted and that are published on its website.

Personal data (name, age, gender, contact details, medicinal product use data, medical history data, data on existing or preexisting conditions, data on signs and symptoms, product-use data, and other data).

UBG may collect data of minors if and only if the USER, who is the person providing such data, expressly declares that they are legally authorized to do so.

How data will be processed

Personal data entered shall be processed responsibly and confidentiality shall be maintained by establishing and effectively maintaining administrative, technical, and physical security measures, preventing improper alteration, destruction, use, access, or disclosure.

Even though UBG has implemented commonly used security in its physical and digital data filing systems, UBG does not guarantee the absolute integrity and security of the information.

Additionally, UBG uses the personal information entered solely for the following purposes:

• Collect, store, and establish a database of potential collaborators or contractors.
• Collect, store, and establish a database of possible adverse events or confirmed adverse events of medicinal products and medical/dental devices.
• Analyze and process this information in order to identify signals or trends of possible adverse events and to establish Pharmacovigilance and Technovigilance activities.
• Transmit the analyzed and processed information to manufacturers, product owners, product holders, and related companies so that they may carry out Pharmacovigilance, Technovigilance, and Sanitary Regulatory Affairs activities.
• Generate reports submitted to local, national, and international Health Authorities.

UBG shall be exclusively responsible for the processing and use of the personal data it obtains directly through the SITES. UBG disclaims any liability that may arise from the user's any improper use or use contrary to the purposes of the systems published on the institutional website. UBG is not responsible for the truthfulness or accuracy of the information contained in links to other websites or of information provided by third parties.

Access and rectification

UBG recognizes data subjects' right of Access and Rectification regarding the handling or processing of their data, for which they must follow the applicable process by sending an express request to info@ubg.com.ec

Cookie policy

What are cookies?

Cookies are small text files that are downloaded and stored on the user's computer or device when accessing our website. These cookies allow the website to recognize the user, remember their preferences, and improve their browsing experience.

Types of cookies used

We use two types of cookies on our website:

• a) Technical cookies: those necessary for the proper functioning of the website, allowing navigation through its sections and access to its functionalities.
• b) Analytics cookies: those that allow us to measure and analyze users' browsing on our website, in order to improve our products and services.

How are cookies used?

Cookies are used to collect information about the user's browsing on our website, including pages visited, time spent on the website, type of device used, operating system, language, and other statistical data.

How can cookies be controlled?

The user may control and manage the use of cookies in their web browser, and may delete or disable them at any time. However, by disabling technical cookies, the user may not be able to access certain website functionalities.

How is the user's privacy protected?

The information collected through cookies is used solely for statistical purposes and to improve our products and services, and is never shared with third parties without the user's prior consent.

Changes to the cookie policy

We reserve the right to update or amend this cookie policy at any time, without prior notice. Therefore, it is recommended that this policy be reviewed periodically to stay informed of any change or update.

If you have any questions or concerns about our cookie policy, please do not hesitate to contact us through our service channels.

Legal basis supporting data processing

UBG bases the processing it gives to personal data on the following legal instruments:

• Organic Law on Personal Data Protection.
• Numeral 12 of Article 66 of the Constitution of the Republic of Ecuador provides: "The following is recognized and guaranteed to persons: (...) 19. The right to the protection of personal data, which includes access to and decision over information and data of this nature, as well as their corresponding protection. The collection, filing, processing, distribution, or dissemination of such data or information shall require the authorization of the data subject or a mandate of the law";
• Article 92 of the Constitution of the Republic of Ecuador provides that every person shall have the right to know of the existence of and to access the documents, genetic data, banks or files of personal data, and reports about themselves or their property that appear in public or private entities, in physical or electronic media;
• Electronic Commerce Act, Article 5 – Confidentiality and reserve, Article 8 – Retention of data messages, and Article 9 – Data protection;
• Article 4 of the Organic Law of the National System of Public Data Registration provides: "Responsibility for the information.- Public and private sector institutions and natural persons that currently or in the future administer databases or public data registers are responsible for the integrity, protection, and control of the registers and databases under their charge. Such institutions shall be liable for the truthfulness, authenticity, custody, and due conservation of the registers. Responsibility for the truthfulness and authenticity of the registered data is exclusive to the declarant when the declarant provides all of the information (...)";
• Article 6 of the Organic Law of the National System of Public Data Registration provides: "Accessibility and confidentiality.- Personal data are confidential, such as: ideology, political or trade-union affiliation, ethnicity, health status, sexual orientation, religion, immigration status, and other data relating to personal privacy and especially that information whose public use would violate the human rights enshrined in the Constitution and international instruments(...)";
• The Organic Code of the Social Economy of Knowledge, Creativity and Innovation (COESCCI), in General Provisions, TWENTY-SEVENTH.- "(...) The processing of personal data that includes actions such as the collection, systematization, and storage of personal data shall require the prior and informed authorization of the data subject. The data subject's authorization shall not be required when the processing is carried out by a public institution and has a statistical or scientific purpose; a health or safety protection purpose; or is carried out as part of a public policy guaranteeing constitutionally recognized rights".