Axcella Health Inc. (“Axcella,” “We” or “Us”)

PRIVACY NOTICE

Axcella respects your privacy and is committed to protecting it through our compliance with this Notice.  This Notice explains what types of personal data Axcella may collect from you and how we use it.  It also explains the policies and practices that we have developed to safeguard personal data and to comply with applicable data protection laws.  Please read this Notice carefully to understand what personal data we collect, how we collect it, how we use it, who we may disclose it to, and how you can manage it.

If you have any questions concerning Axcella’s privacy practices or wish to access or correct personal data that Axcella has collected from you, please contact us as described in Section A, “How to Contact Us.”
 

A.  HOW TO CONTACT US

Company name and mailing address:
Axcella Health Inc.
840 Memorial Drive, Cambridge
Cambridge, MA 02139

Person responsible for privacy inquiries:
Heidy Abreu

Email address
Privacy@Axcellahealth.com


B.  DATA WE COLLECT ABOUT YOU


We may collect, use, store and transfer different types of personal data about you. We have grouped them together as follows:

  • Identity Data includes first name, maiden name, last name, username or similar identifier, marital status, title, date of birth and gender.

  • Contact Data includes billing address, delivery address, email address and telephone numbers.

  • Financial Data includes bank account, payment card details, and payroll data.

  • Transaction Data includes details about payments to and from you and other details of products and services you have purchased from us.

  • Technical Data includes internet protocol (IP) address, your login data, browser type and version, time zone setting and location, browser plug-in types and versions, operating system and platform and other technology on the devices you use to access our website or intranet.

  • Profile Data includes your username and password on our website, our intranet, purchases or orders made by you, your preferences, and feedback and survey responses.

  • Usage Data includes information about how you use our website, intranet, products and services.

  • Marketing and Communications Data includes your preferences in receiving marketing communications from us and our third parties and your communication preferences.

  • Special Categories of Personal Data: includes details about your race or ethnicity, religious or philosophical beliefs, sex life, sexual orientation, political opinions, trade union membership, information about your health (including health-related personal data that Axcella or its agent may use to determine your eligibility for clinical research or to conduct a clinical trial) and genetic and biometric data.

C.  HOW WE COLLECT INFORMATION ABOUT YOU

You provide information yourself. You may give us data such as Identity, Contact, Financial, or Special Categories of Data in your interactions with us in person, by mail, phone, and e-mail or otherwise. This includes personal data you provide when you:

  • apply for our products or services;

  • subscribe to our service or publications;

  • request marketing communications to be sent to you;

  • give us some feedback;

  • provide unsolicited information to us;

  • apply for employment with us or when you become an employee; or

  • express interest in participating in our clinical research program.

We collect some information automatically. As you interact with our website or intranet, we may automatically collect Technical Data about your equipment, browsing actions and patterns. We collect this personal data by using cookies, and other similar technologies. For additional information about how Axcella uses cookies and similar technologies, see Section H.

Third parties (or publicly available sources). We may receive categories of personal data about you from various third parties and public sources as set out below:

  • Technical Data from analytics providers such as Google; advertising networks and search information providers.

  • Contact, Financial and Transaction Data from providers of technical, payment and delivery services.

  • Identity and Contact Data from data brokers, aggregators or recruitment agencies.

  • Identity and Contact Data from publicly availably sources.

Special Categories of Data including Health Data from entities such as those assisting us with our clinical research.


D.  HOW WE USE YOUR PERSONAL DATA

We use your personal data to:

  • Operate our business;

  • Deliver our products and services;

  • Screen you for clinical study eligibility;

  • Comply with regulatory requirements;

  • Process, complete and fulfill your requests;

  • Provide customer service and respond to requests or inquiries;

  • Communicate with you;

  • Tailor our marketing programs and campaigns; and

  • Provide you with newsletters, articles, alerts, announcements, invitations, and other information about products, brands, health topics and disease states.

We also use your personal data for data analysis, to better understand how our products and services impact you and those you care for, to track and respond to concerns, for fraud prevention and to further develop and improve our products and services. In addition, we use the information you provide to comply with our regulatory monitoring and reporting obligations including those related to adverse events, product complaints and patient safety.

For those visiting this site that provide personal data from within the European Economic Area, please see the “Supplemental European Privacy Notice” in Section N for additional information.

E.  MARKETING

We strive to provide you with choices regarding certain personal data uses, particularly around marketing and advertising. We have established the following personal data control mechanisms:

  • Opting in. You will receive marketing communications from us if you have requested information from us or have opted-in to receive our marketing information.

  • Third-party marketing. We will get your express opt-in consent before we share your personal data with any company outside Axcella for marketing purposes.

  • Opting out. You can ask us or third parties to stop sending you marketing messages at any time by following the opt-out links on any marketing message sent to you. Where you opt-out of receiving these marketing messages, this will not apply to personal data provided to us as a result of a product/service purchase, warranty, product/service experience or other transactions.

  • Google Analytics. To opt out of being tracked by Google Analytics across all websites, visit http://tools.google.com/dlpage/gaoptout.

E. HOW WE SHARE YOUR PERSONAL DATA

We may share your personal data with the parties set out below for the purposes set out in Section D.

  • Internal Third Parties: departments in Axcella that have a business need to access the information.

  • External Third Parties: service providers who provide IT and system administration services and data analytics or third parties who provide services to support a study or a clinical research program sponsored by Axcella.

  • Other Third Parties: third parties to whom we may choose to sell, transfer, or merge parts of our business or our assets. Alternatively, we may seek to acquire other businesses or merge with them. If a change happens to our business, then the new owners may use your personal data in the same way as set out in this Privacy Notice.

  • Professional advisers: advisors (e.g., lawyers, bankers, auditors and insurers) who provide consultancy, banking, legal, insurance and accounting and payroll services.

  • Supervisory Authorities: Revenue and Customs, IRS and FDA, regulators and other authorities who require reporting of processing activities in certain circumstances.

We require all third parties to respect the security of your personal data and to treat it in accordance with the law. We do not allow our third-party service providers to use your personal data for their own purposes and only permit them to process your personal data for specified purposes and in accordance with our instructions.

G. HOW WE SECURE YOUR PERSONAL DATA

We have put in place appropriate security measures to prevent your personal data from being accidentally lost, used or accessed in an unauthorised way, altered or disclosed. In addition, we limit access to your personal data to those employees, agents, contractors and other third parties who have a business need to know. They will only process your personal data on our instructions and they are subject to a duty of confidentiality.

We have put in place procedures to deal with any suspected personal data breach and will notify you and any applicable regulator of a breach where we are legally required to do so.

H. COOKIES AND SIMILAR TECHNOLOGIES

“Cookies” are small text files that are placed on your computer or mobile device in order to identify your web browser and the activities of your computer or mobile device when using this website. Cookies are used to personalize your experience, to assist you in using the website (such as saving time by not having to re-enter your name each time you use the website), and to allow us to statistically monitor how you are using the website to help us improve our products and services.

You do not have to accept cookies to use our website. Although most browsers are initially set to accept cookies, You may reset your browser to notify you when you receive a cookie or to reject cookies generally. Most browsers offer instructions on how to do so in the “Help” section of the toolbar. However, if you reject cookies, certain features or resources of the website may not work properly and you may experience some loss of convenience.

“Action tags,” also known as web beacons or gif tags, are a web technology used to help track website usage information, such as how many times a specific page has been viewed. Action tags are invisible to you, and accessing any online service, including advertisements, from the website may result in the creation of action tags.

By using cookies and action tags together, we are able to gain valuable information to improve our website and other services and measure the effectiveness of our marketing efforts.

To find out more about cookies, including how to see what cookies have been set and how to manage and delete them, visit www.aboutcookies.org or www.allaboutcookies.org.

I. HOW WE RESPOND TO DO NOT TRACK SIGNALS

Some web browsers may transmit “do-not-track” signals to websites with which the browser communicates. Websites linked to this Privacy Notice do not currently respond to these “do-not-track” signals.


J. CALIFORNIA PRIVACY RIGHTS

California Civil Code Section 1798.83 permits California residents who are individual customers of Axcella products to request certain information regarding its disclosure of personal data to third parties for their direct marketing purposes. To make such a request, please contact us using our contact information listed in Section A (“How to Contact Us”).

Be sure to include your name and address. You can include your email address if you want to receive a response by email. Otherwise, we will respond by postal mail within the time required by law.


K. CHILDREN

While in some instances we may collect personal data about children with the consent of a parent or guardian, such as clinical activities or for patient support programs, we do not otherwise knowingly solicit data from, or market to, children. If a parent or guardian becomes aware that his or her child has provided us with personal data, he or she should contact us as described in Section A of this Notice (“How to Contact Us”). We will take reasonable steps to delete such data from our database within a reasonable time.


L. LINKS TO OTHER SITES

This Notice does not address, and Axcella is not responsible for the terms of use, information or privacy practices of any other websites or online services not owned or operated by Axcella, including any such sites or services to which our Axcella website links.  The inclusion of a link on the Axcella website does not imply our endorsement of the linked site or service.


M. PRIVACY NOTICE UPDATES

Axcella may update this Notice from time to time.  Please check this Notice periodically for changes.  If we make any changes, the updated Notice will be posted with a revised effective date.  We encourage you to periodically review this page for the latest information on our privacy practices.


N. SUPPLEMENTAL EUROPEAN PRIVACY NOTICE

European Union Regulation 2016/679 of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (the “General Data Protection Regulation” or “GDPR”) requires Axcella as the data controller to provide additional and different information about its data processing practices to data subjects in the European Economic Area (“EEA”). If you are a data subject within the EEA, this Supplemental European Privacy Notice applies to you in addition to the provisions above.

  1. HOW WE USE YOUR PERSONAL DATA

We will only use your personal data when the law allows us to so. Most commonly, we will use your personal data in the following circumstances:

  • We need to perform the contract we are about to enter into or have entered into with you.

  • It is necessary for our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests.

  • We need to comply with a legal or regulatory obligation.

  • It is necessary for scientific research purposes.

    We may also use your personal data in the following situations, which are likely to be rare:

  • We need to protect your vital interests (or someone else's).

  • It is needed in the public interest or for official purposes.

We may also rely on consent as a legal basis for processing your personal data in certain circumstances, like sending direct marketing communications to you via email or text message. You have the right to withdraw consent to marketing at any time by contacting us.

We have set out below, in a table format, a description of many of the ways we plan to use your personal data, and which of the legal bases we rely on to do so. We have also identified what our legitimate interests are where appropriate.

Note that we may process your personal data for more than one lawful ground depending on the specific purpose for which we are using your data. Please contact us if you need additional details about the specific legal ground we are relying on to process your personal data.

TOS-Table.jpg

2. CLINICAL TRIAL DATA

We undertake clinical studies within the EEA and we will use information from subjects’ medical records and other health data in order to strive to improve healthcare. If a person is determined to be eligible for a clinical study and decides to participate, important information (contained in what is known as an informed consent form) is reviewed with each patient by a study professional at the study site. Each patient must read and sign this informed consent form, which describes possible health risks and possible benefits of participating in the study, as well as what personal data will be collected in the study and who is able to use or disclose any personal information, before enrolling. Anyone can decline to participate in a study at any time.

As a pharmaceutical organisation we have a legitimate interest in using information relating to your health for research studies when you agree to take part in a research study. Our exception to the general principle not to process special categories of data is that processing is necessary for scientific research purposes. This means that we will use your health data that we collect during a research study when we act as the data controller for such studies in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personal data necessary to achieve our purpose(s).


3. CHANGE OF PURPOSE

We will only use your personal data for the purposes for which we collected it, unless we reasonably consider that we need to use it for another reason and that reason is compatible with the original purpose.

If we need to use your personal data for an unrelated purpose, we will notify you and we will explain the new legal basis.

Please note that we may process your personal data without your knowledge or consent, in compliance with the above rules, where this is required or permitted by law.


4. INTERNATIONAL TRANSFERS OF PERSONAL DATA

We are based outside the European Economic Area, so the processing of your personal data may involve a transfer of data outside the EEA. Information on how to contact the appropriate Axcella resource for privacy inquiries related to international data transfers can be found in Section A of this Notice (“How to Contact Us”).

Whenever we transfer your personal data out of the EEA, we ensure a similar degree of protection is afforded to it by ensuring at least one of the following safeguards is implemented:

  • We will only transfer your personal data to countries that have been deemed to provide an adequate level of protection for personal data by the European Commission.

  • Where we use certain service providers, we may use specific contracts approved by the European Commission which give personal data the same protection it has in Europe.

  • Regarding transfers to the US, we are required to incorporate the model clauses in agreements for transfer provided by the European Commission in order to provide similar protection to personal data shared within Europe.


5. HOW LONG WE RETAIN YOUR PERSONAL DATA

We will only retain your personal data for as long as necessary to fulfil the purposes we collected it for, including for the purposes of satisfying any legal, accounting, or reporting requirements.

To determine the appropriate retention period for personal data, we consider the amount, nature, and sensitivity of the personal data, the potential risk of harm from unauthorised use or disclosure of your personal data, the purposes for which we process your personal data and whether we can achieve those purposes through other means, and the applicable legal requirements.

In some circumstances we may anonymise your personal data (so that it can no longer be associated with you) for research or statistical purposes in which case we may use this information indefinitely without further notice to you.

6. YOUR PERSONAL PROTECTION RIGHTS

Under certain circumstances, visitors from within the EEA have the following data protection rights in accordance with applicable law:

  • access to your personal data.

  • correction of your personal data.

  • erasure of your personal data.

  • object to processing of your personal data.

  • restrict of processing your personal data.

  • transfer of your personal data.

  • withdraw consent to any consent that you have previously given.

If you wish to exercise any of the rights set out above, please contact us using the information contained in Section A. You can also contact the Supervisory Authority in the country of your residence within the EU at this link for advice or to make a complaint. Please be aware that your rights in relation to clinical research data may be limited.

You will not have to pay a fee to access your personal data (or to exercise any of the other rights). However, we may charge a reasonable fee or refuse to comply with your request if it is clearly unfounded, repetitive or excessive.

We may need to request specific information from you to help us confirm your identity and ensure your right to access your personal data (or to exercise any of your other rights). This is a security measure to ensure that personal data is not disclosed to any person who has no right to receive it. We may also contact you to ask you for further information in relation to your request to speed up our response.

We try to respond to all legitimate requests within one month. Occasionally it may take us longer than a month if your request is particularly complex or you have made a number of requests. In this case, we will notify you and keep you updated.

Effective Date: August 5, 2019