Privacy Policy - Elgan Pharma

Privacy and Data Protection Policy and Notice

Elgan Pharma Ltd. (“Elgan Pharma”, “we”, “us”, “our” or the “Company”) is a late-stage neonatology-focused biotechnology company, dedicated to developing therapies for preterm infants and other neonatal indications (the “Services”). As part of the development and safety assessment of its therapies, the Company conducts ongoing Clinical Trials (the “Clinical Trials”).

Elgan Pharma Ltd. respects the privacy of its clients, partners, clinical trial participants, vendors, service providers and website visitors, and is committed to protecting the personal information that is shared with us (these and any others with respect to whom we collect personal data, collectively referred to below as “you” or “Data Subjects”).

This policy and notice (the “Privacy Policy”) explains the types of information we collect from you, that we receive about you or that you may provide in the course of your interest in our Services, business transactions, conferences or when you visit our website. This privacy policy also explains, to the extent possible, which information we collect regarding participants of our Clinical Trials. We are transparent about our practices regarding the information we collect, use, maintain and process and describe our practices in this policy and notice. Please read the following carefully to understand our practices regarding your personal data and how we will treat it.

For the purposes of the EU General Data Protection Regulation and the UK Data Protection Law 2018 (together the “GDPR”), as well as other applicable privacy laws, Elgan Pharma is a data controller (“Controller”) in relation to the personal data of the representatives of our clients and prospective clients, employees, partners, vendors, website visitors and Clinical Trial participants.

WHICH INFORMATION MAY WE COLLECT?

Summary: we collect various categories of personal data in order to meet our contractual obligations, and also to meet various legitimate interests, such as fraud prevention and marketing. We also collect data in order to conduct Clinical Trials.

One type of data collected is non-identifiable and anonymous information (“non-personal data”). We also collect several categories of personal data (“Personal Data”), as described below.

(a) Contact Information and other personal data provided voluntary by you or your organization:

We collect Personal Data when you or your organization send it to us, or when a vendor, distributor or other business partner, sends it to us; we also collect Personal Data through our website and through our interactions with you.

Personal Data which we collect consists of any details which are personally identifiable and which are provided consciously and voluntarily by you, or by an organization you represent or are associated with. We collect Personal Data required to provide Services when you register interest, or when you provide us such information in meetings or conferences, or in the course of preparing a contract, or when contacting us or submitting requests for information or support, through your use of our website, by email, or other ways in which you communicate and interact with us. This personal data generally includes your name (first and last), email address, phone number, job title, company name, country and other information you may choose to provide to Elgan Pharma. Our CROs collect on our behalf data regarding our Clinical Trial Investigators and members of our clinical site teams. This data includes, in addition to the above data, other data provided actively and voluntarily by you, such as data included in your CV and its attachments, type of completed GCP training (Good Clinical Practice), previous experience in clinical trials and other qualifications.

You do not have any legal obligation to provide any information to Elgan Pharma. However, we require certain information in order to perform contracts, to conduct our Clinical Trials, for internal audit purposes or to provide any Services. If you choose not to provide us with certain information, then we may not be able to provide you or your organization with some or all of the Services or conclude a contract with you.

We may also use this Personal Data to send you communications and/or direct marketing materials on our Services, products or offers we feel may be of interest to you, subject to separate consent, if needed under Applicable Privacy law.

(b) Clinical Trial Data:

We obtain clinical data regarding our Clinical Trial participants (“Clinical Trial Data”). These participants are typically infants, enrolled in our trials by their parents/legal guardians, after collection of their freely given informed consent, including an information clause regarding the processing of personal data.

Clinical Trial Data includes various data categories, depending on the specific trial. These categories include: demographic data, medical and family history and medical records, physical examination results, vital signs, blood tests, concomitant medications, allergies, adverse events, major morbidities, infant and toddler development and behavioral scores, neurodevelopment disability composite and other data, as detailed in the relevant trial’s protocol. Much of, though not all of, this data, will be collected by the participant’s hospital regardless of its participation in the trial.

We obtain Clinical Trial Data only in pseudonymized form, under unique serial numbers. We do not directly obtain source medical records or other data which contains directly identifying information of our Clinical Trial participants or their parents/legal guardians (such as names and contact information). Directly identifying information is only accessed by the relevant delegated research site teams and Principal Investigators, as well as limited third parties, which may require specific access for auditing, monitoring and inspection purposes. These third parties are required by law and contractual obligations to maintain confidentiality of participants’ personal data. Such third parties may include delegated CRO representatives; the IRB/REB; the Food and Drug Administration (FDA) and other regulatory authorities.

If the results of our Clinical Trials are published, participants’ identities further remain fully confidential.

When you are using our website, we are aware of it and gather, collect and record the information relating to such usage, either independently or through the help of third-party services as detailed below. This includes technical information and behavioral information such as the user’s Internet protocol (IP) address used to connect your device to the Internet, your uniform resource locators (URL), operating system, type of browser, browser plug-in types and versions, screen resolution, Flash version, time zone setting.

We likewise place functional cookies on your browsing devices (see 'Cookies' section below).

WHAT ARE THE PURPOSES OF PERSONAL DATA WE COLLECT?

Summary: we process Personal Data to conduct clinical trials, operate our website, meet our obligations, protect our rights and manage our business.

We will use Personal Data to provide and improve our Services to our clients and others, operate our website, meet our contractual, ethical and legal obligations and conduct clinical trials. All Personal Data will remain accurate, complete and relevant for the stated purposes for which it was processed, including for example:

Processing which is necessary for scientific health research purposes:

using Clinical Trial Data for the conduction of Clinical Trials and medical research related to our Services and therapies.

Processing which is necessary for the performance of a contract to which you are a party or in order to take steps at your request prior to entering into a contract:

carrying out our obligations arising from any contracts entered into between you and Elgan Pharma and/or any contracts entered into with Elgan Pharma and to provide you with the information, support and Services that you request from Elgan Pharma;
verifying and carrying out financial transactions in relation to payments you make in connection with the Services.

Processing which is necessary for the purposes of the legitimate interests pursued by Elgan Pharma or by a third party of providing an efficient and wide-ranging service to clients:

notifying you about changes to our website and Services;
contacting you to give you commercial and marketing information about events or promotions or additional Services offered by Elgan Pharma which may be of interest to you, provided that you express your consent for such communications when required under applicable law (you may unsubscribe from these communications at any point);
soliciting feedback in connection with the Services;
tracking use of our website to enable us to optimize it;
for security purposes.

Processing which is necessary for compliance with a legal obligation to which Elgan Pharma is subject:

compliance and audit purposes, such as meeting our reporting obligations in our various jurisdictions, anti money laundering, tax related obligations, and for crime prevention and prosecution in so far as it relates to our staff, clients, service providers, facilities etc;
clinical trial reliability and safety purposes, such as safety reporting; processing in the context of an inspection by national competent authority; retention of clinical trial data in accordance with archiving obligations;
if necessary, we will use Personal Data to enforce our terms, policies and legal agreements, to comply with court orders and warrants and assist law enforcement agencies as required by law, to collect debts, to prevent fraud, infringements, identity thefts and any other service misuse, and to take any action in any legal dispute and proceeding.

SHARING DATA WITH THIRD PARTIES

Summary: we share Personal Data with our service providers, partners, and group companies, and authorities where required.

We transfer Personal Data to:

Members of our Group: If in the future we have affiliates - which means affiliate companies - whether wholly or partially owned by Elgan Pharma, and co-owned companies – we will transfer Personal Data to them.

Third Parties. We transfer Personal Data to third parties in a variety of circumstances. We endeavor to ensure that these third parties use your information only to the extent necessary to perform their functions, and to have a contract in place with them to govern their processing on our behalf. These third parties include business partners, suppliers, affiliates, agents and/or sub-contractors for the performance of any contract we enter into with you. They assist us in providing the Services we offer, processing transactions, fulfilling requests for information, receiving and sending communications, analyzing data, providing IT and other support services or in other tasks, from time to time. These third parties also include analytics and search engine providers that assist us in the improvement and optimization of our website, and our marketing.

We periodically add and remove third party providers. At present services provided by third-party providers to whom we transfer Personal Data include also the following:

Website analytics (currently Google Analytics);
Document management and sharing services;
Client ticketing and support;
On-site and cloud-based database services;
CRM software;
Data security, data backup, and data access control systems;
Our lawyers, accountants, and other standard business software and partners.

We transfer Clinical Trial Data only to third parties who assist in the conduction of our Clinical Trials and medical research, including:

Contract Research Organizations
Ethics Committees
Competent Authorities
Security and Data Monitoring Committees, auditors, prosecutors, inspectors, other doctors, nurses or other persons entities involved in conducting the Clinical Trials
external parties cooperating within the framework of the Clinical Trials or other technical and organizational service providers, enabling the provision of health services and management of their organization: ICT service providers, diagnostic equipment suppliers, providers of legal, accountancy, control, advisory and support services (courier)
eClinical digital platforms (e.g. EDC, CTMS).

In addition, we will disclose Personal Data to third parties if some or all of our companies or assets are acquired by a third party including by way of a merger, share acquisition, asset purchase or any similar transaction, in which case Personal Data will be one of the transferred assets. Likewise, we transfer Personal Data to third parties if we are under a duty to disclose or share your Personal Data in order to comply with any legal or audit or compliance obligation, in the course of any legal or regulatory proceeding or investigation, or in order to enforce or apply our terms and other agreements with you or with a third party; or to assert or protect the rights, property, or safety of Elgan Pharma, our clients, or others. This includes exchanging information with other companies and organizations for the purposes of fraud protection and credit risk reduction and to prevent cybercrime.

For avoidance of doubt, Elgan Pharma may transfer and disclose non-Personal Data to third parties at its own discretion.

WHERE DO WE STORE YOUR DATA?

Summary: we store your Personal Data across multiple locations globally

We store your Personal Data on servers owned or controlled by Elgan Pharma, or processed by third parties on behalf of Elgan Pharma, by reputable service providers (see the following section regarding international transfers).

eCRFs (Electronic Case Report Forms) of our Clinical Trials are stored and processed on Medrio (“Medrio”), our CTMS platform hosted on Google Cloud Platform in the EU. Medrio’s privacy policy may be found at: https://medrio.com/privacy-policy/. Clinical Trial data is also stored and processed on Flex Databases (“Flex”), a digital platform we use for trial safety monitoring purposes (PV). Data on Flex is hosted at qualified hosting facilities local to the EU. Flex’s privacy policy may be found at: https://flexdatabases.com/data-protection-statement/.

INTERNATIONAL DATA TRANSFERS

Summary: we transfer Personal Data within and to the EEA, UK, USA, Israel and elsewhere, with appropriate safeguards in place.

Personal Data collected in the EU and UK is transferred to, and stored and processed at, a destination outside the European Economic Area (EEA) and the UK. This includes transfer to our headquarters in Israel, a jurisdiction deemed adequate by the EU Commission, and to the USA, not currently deemed adequate. As stated above, Clinical Trial Data is stored and processed on platforms hosted in the EU. This data is accessed by our headquarters in Israel for the purposes of conducting the clinical trial and research, and may also be accessed by some of our vendors (such as CROs) which are local to the US.

Where your Data is transferred outside of the EEA and UK, we will take all steps reasonably necessary to ensure that your Data is subject to appropriate safeguards, including entering into contracts that require the recipients to adhere to data protection standards that are considered satisfactory under EU law and other applicable, and that it is treated securely and in accordance with this Privacy Policy. Transfers from the EEA to Israel are made based on an adequacy ruling by the EU Commission. Transfers from the EEA to the USA are made based on the Standard Contractual Clauses published by the EU Commission. Transfers from the UK to the EEA and to Israel and made based on UK’s adequacy regulations. Transfers from the UK to the USA are made based on the UK’s International Data Transfer Addendum to the EU Commission Standard Contractual Clauses. For more information about these safeguards, please contact us as detailed below.

We transfer Personal Data to locations outside of the EEA and UK, including in particular USA and Israel, in order to:

store or backup the information;
enable us to provide you with the Services and fulfill our contract with you;
conduct our Clinical Trials and related research, monitoring and data management;
fulfill any legal, audit, ethical or compliance obligations which require us to make that transfer;
facilitate the operation of our group businesses, where it is in our legitimate interests and we have concluded these are not overridden by your rights;
to serve our clients across multiple jurisdictions; and
to operate our affiliates in an efficient and optimal manner.

DATA RETENTION

Summary: we retain Personal Data according to our data retention policy, as required to conduct clinical research, meet our obligations, protect our rights, and manage our business.

Elgan Pharma will retain Personal Data it processes only for as long as required in our view, to provide the Services, to conduct our Clinical Trials, and as necessary to comply with our legal and other obligations, to resolve disputes and to enforce agreements. We will also retain Personal Data to meet any audit, compliance and business best-practices.

Data that is no longer retained will be anonymized or deleted. Likewise, some metadata and statistical information concerning the use of our website and Services are not subject to the deletion procedures in this policy and will be retained by Elgan Pharma. We will not be able to identify you from this data. Some data may also be retained on our third-party service providers’ servers until deleted in accordance with their privacy policy and their retention policy, and in our backups until overwritten.

SERVICES AND WEBSITE DATA COLLECTION AND COOKIES

Summary: with your consent, we place cookies on your device. You control our use of cookies through a cookie management tool on our websites, or through your device and browser.

Elgan Pharma uses cookies, pixel tags and other forms of identification and local storage (together referred to below as “cookies”) to distinguish you from other users of the website and of websites of our network. This helps us to provide you with a good user-experience when you browse the website and websites of our network and also allows us to improve our website and our Services.

In many cases, these cookies lead to the use of your device’s processing or storage capabilities. Some of these cookies are set by us, others by third parties; some only last as long as your browser session, while others can stay active on your device for a longer period of time.

These cookies can fall into several categories: (i) those that are necessary for functionality or Services that you request or for the transmission of communications (functionality cookies); (ii) those that we use to carry out website performance and audience metrics (analytics cookies) and (iii) the rest (tracking across a network of other websites, advertising, etc.) (other cookies).

Internet browsers allow you to change your cookie settings, for example to block certain kinds of cookies or files. You can therefore block cookies by activating the setting on your browser that allows you to refuse the setting of all or some cookies. However, if you use your browser settings to block all cookies, you may not be able to access all or parts of the website, due to the fact that some may be functionality cookies. For further information about deleting or blocking cookies, please visit: https://www.aboutcookies.org/how-to-delete-cookies/

Functionality cookies do not require your consent. For other cookies, however, we request your consent before placing them on your device. You can allow cookies in your browser settings and use our website cookie management too.

To consult the list of cookies which we use on our website, please check your browser's settings. Instructions: https://www.wikihow.com/View-Cookies.

You can also see the full list of our cookies, their category, purpose and duration by clicking “customize” on our cookie banner.

SECURITY AND STORAGE OF INFORMATION

Summary: we take data security very seriously, invest in security systems, and train our staff. In the event of a breach, we will notify the right people as required by law.

We take great care in implementing, enforcing and maintaining the security of the Personal Data we process. Elgan Pharma implements, enforces and maintains security measures, technologies and policies to prevent the unauthorized or accidental access to or destruction, loss, modification, use or disclosure of Personal Data. We likewise take steps to monitor compliance of such policies on an ongoing basis. Likewise, we take industry standard steps to ensure our website and Services are safe and to prevent unauthorized access to our data bases. The eClinical platforms we use, are also committed to privacy and security best practices, including strong access control, audit trails, regular back up and encryption of personal data.

Note however, that no data security measures are perfect or impenetrable, and we cannot guarantee that unauthorized access, leaks, viruses and other data security breaches will never occur.

Within Elgan Pharma, we endeavor to limit access to Personal Data to those of our personnel who: (i) require access in order for Elgan Pharma to fulfill its obligations, including also under its agreements, and as described in this Privacy Policy, and (ii) have been appropriately and periodically trained with respect to the requirements applicable to the processing, care and handling of the Personal Data, and (iii) are under confidentiality obligations as may be required under applicable law.

Elgan Pharma acts in accordance with its policies and with applicable law to promptly notify the relevant authorities and data subjects in the event that any Personal Data processed by Elgan Pharma is lost, stolen, or where there has been any unauthorized access to it, all in accordance with applicable law and on the instructions of qualified authority. Elgan Pharma promptly takes reasonable remedial measures.

DATA SUBJECT RIGHTS

Summary: depending on the law that applies to your Personal Data, you may have various data subject rights, such as rights to access, erase, and correct Personal Data, and information rights. We will respect any lawful request to exercise those rights.

Data subjects with respect to whose data GDPR applies, have rights under GDPR and local laws, including, in different circumstances, rights to data portability, rights to access data, rectify data, object to processing, and erase data.

It is clarified for removal of doubt that where Clinical Trial Data has already been processed in relation to our Clinical Trials or included in academic research material, it may no longer be feasible for such data to be accessed, erased, rectified etc.

It is clarified that where Personal Data is provided by a client being the data subject's employer, such data subject rights will have to be effected through that client, the data subject’s employer. In addition, data subject rights cannot be exercised in a manner inconsistent with the rights of Elgan Pharma employees and staff, with Elgan Pharma proprietary rights, and third-party rights. As such, job references, reviews, internal notes and assessments, documents and notes including proprietary information or forms of intellectual property, cannot be accessed or erased or rectified by data subjects. In addition, these rights may not be exercisable where they relate to data that is not in a structured form, for example emails, or where other exemptions apply. If processing occurs based on consent, data subjects have a right to withdraw their consent.

A data subject who wishes to modify, delete or retrieve their Personal Data, may do so by contacting Elgan Pharma (privacy@ElganPharma.com). Requests to exercise data subject rights in the framework of our Clinical Trials may also be submitted to the relevant Principal Investigator.

Note that Elgan Pharma may have to undertake a process to identify a data subject exercising their rights. Elgan Pharma may keep details of such rights exercised for its own compliance and audit requirements. Please note that Personal Data may be either deleted or retained in an aggregated manner without being linked to any identifiers or Personal Data, depending on technical commercial capability. Such information may continue to be used by Elgan Pharma.

Data subjects in the EU and UK have the right to lodge a complaint, with a data protection supervisory authority in the place of their habitual residence. If the supervisory authority fails to deal with a complaint, you may have the right to an effective judicial remedy.

MINORS

We do not knowingly collect or solicit information or data from or about children under the age of 16 without parental consent, or knowingly allow children under the age of 16 to register for Elgan Pharma Services. Any data regarding minors who are our Clinical Trial participants is only collected after obtaining parental informed consent regarding their participation in the relevant trial and informing their parent/legal guardian regarding the data processing involved in the trial. If you are under 16, do not register or attempt to register for any of the Elgan Pharma Services or send any information about yourself to us. If we learn that we have collected or have been sent Personal Data from a child under the age of 16 without appropriate permissions, we will delete that Personal Data as soon as reasonably practicable without any liability to Elgan Pharma. If you believe that we might have collected or been sent information from a minor under the age of 16, please contact us at: privacy@ElganPharma.com , as soon as possible.

THIRD PARTY LINKS

In the future, we may include third party links on our website. Please note that this privacy policy only applies to the Personal Data that we (or third parties on our behalf) collect from or about you and we cannot be responsible for personal information collected and stored by third parties. Third party websites have their own terms and conditions and privacy policies, and you should read these carefully before you submit any personal information to these websites. We do not endorse or otherwise accept any responsibility or liability for the content of such third-party websites or third-party terms and conditions or policies.

CHANGES TO THIS PRIVACY POLICY

The terms of this Privacy Policy will govern the use of the website, and any information collected in connection with Elgan Pharma’s contractual obligations, Services, Clinical Trials and medical research. Elgan Pharma may amend or update this Privacy Policy from time to time. The most current version of this Privacy Policy will be available at: https://elganpharma.com/privacy-policy/. Changes to this Privacy Policy are effective as of the stated “Last Revised” date and your continued use of our Services will constitute your active acceptance of the changes to and terms of the Privacy Policy.

Elgan Pharma aims to process only adequate, accurate and relevant data limited to the needs and purposes for which it is gathered. It also aims to store data for the time period necessary to fulfill the purpose for which the data is gathered. Elgan Pharma only collects data in connection with a specific lawful purpose and only processes data in accordance with this Privacy Policy. Our policies and practices are constantly evolving and improving, and we invite any suggestions for improvements, questions, complaints or comments concerning this Privacy Policy, you are welcome to contact us (details below) and we will make an effort to reply within a reasonable timeframe.

Elgan Pharma’s data protection officer (DPO) may be contacted at: privacy@ElganPharma.com.

Elgan Pharma’s GDPR Article 27 EU representative, AR Representative Services EOOD, may be contacted at info@ar-repservices.com.

* * * * *

Last Revised: December 1, 2022