Privacy Statement

This page gives important information about the collection and use of your personal information by Soleno Therapeutics

This statement is relevant to you if you are:

• Someone living with Prader-Willi syndrome (PWS)
• A parent or caregiver of someone living with PWS
• Someone representing a PWS advocacy organization
• A healthcare practitioner

If you are participating in a clinical trial sponsored by Soleno Therapeutics, refer to the privacy information accompanying the documentation you received when you enrolled.

How we use the personal information of patients, parents, caregivers and representatives of PWS advocacy organizations:

We have summarized below how Soleno uses your personal information. How we interact with you and the information you receive from us will depend on which country you live in.

Personal Information you provide, or which we collect from third parties (such as event coordinators)	What it is used for and why we collect it. For more information, please read the descriptions underneath this table.
Your personal details Name, Email Address, Address, Phone Number, interest in receiving information (including whether individual is living with PWS, advocate, caregiver, or other). Other information you may provide Such as age, date of birth, gender, marital status, health history and status, disability status, Information created as part of communications between us	Contact you about or provide you with general and/or targeted information and materials on: PWS and related conditions; and Soleno’s products, activities, services, and events.
	Responding to your inquiries whether you contact us directly or fill in an inquiry form on our website.
	Support decisions concerning the development, marketing and sale of Soleno’s products and services.
	Research and development into PWS and related conditions.
	Assess interest you may have in participating in an educational event or other activities supporting the effective treatment of PWS, such as Patient Advisory Boards and sending you details; enroll and administer participation and/or attendance in events and activities.
In addition to the information above Professional qualifications, biography, affiliations with non-profit organizations, information available from publicly available sources (including LinkedIn, social media, academic rolls), participation in clinical trials, bank details, amount of payment or transfer of value, form of payment, nature of payment.	Enroll and administer participation and/or attendance in events and activities (such as Patient Advisory Boards), and the administration and recording of payment of remuneration or expenses in respect of such activities (where relevant).
Information generated from your interaction with our website(s) This can include your IP address, browser type, advertising ID through cookies, and your activity on our website(s).	Monitor and measure the performance and effectiveness of Soleno’s marketing activity, including website engagement.
	Create a profile for targeted on-line and off-line communications about Soleno’s activities, products and services (including display ad retargeting).
Moving and still images, quotes you may provide	Promotion of Soleno’s activities, products and services in digital and printed media.
Surveys conducted by us Age/year of birth, gender, marital status, ethnicity, health insurance status and costs, health information generally, health information concerning PWS (such as period since diagnosis with PWS,  whether person is BIPOC, treatments receiving or received for PWS,  birth history, diagnostic history, developmental history, education and employment, independence and daily living skills, medical needs, mental health and challenging behaviors, pregnancy, residential and respite needs, financial impact, relationship impact).	Research and development into PWS and related conditions.
	Support decisions concerning the development, marketing and sale of Soleno’s products and services.
Patient and Caregiver Interviews All information provided as part of an interview or participation in an event, forum or an activity organized by or on behalf of Soleno where personal information is provided. This may include information related to health and/or ethnicity. This may also include moving and still images.	Research and Development into PWS and related conditions.
	Support decisions concerning the development, marketing and sale of Soleno’s products and services.
	Promotion of Soleno’s activities, products and services in digital and printed media.
Patient Support Program (including patient hub) Basic information Name, Email Address, Address, Phone Number, Patient ID Number, contact information for related persons (alternative contact), password Additional information Age/year of birth, gender, marital status, ethnicity, health insurance information and costs, health information generally, health information concerning PWS (such as period since diagnosis with PWS, treatments receiving or received for PWS,  birth history, diagnostic history, developmental history, education and employment, independence and daily living skills, medical needs, mental health and challenging behaviors, pregnancy, residential and respite needs, financial impact, relationship impact).	Enrollment into the Support Program (including eligibility); administration and maintenance of participation.
	Provide targeted information and materials concerning: PWS and related conditions; and Soleno’s activities, products and services.
	Support decisions concerning the development, marketing, and sale of Soleno’s products and services.
	Research and development into PWS and related conditions.
Adverse event and safety reporting Name of the reporter, contact information (email, phone), country of residence, description of the adverse event, product details (batch number, expiry date), patient demographics, patient medical history (existing conditions, allergies), treatment details for the adverse event.	Meet legal and regulatory requirements in respect of the safety and quality of Soleno’s products
All personal information identified above	Protecting our legal rights; monitor regulatory compliance, business administration, quality, and training; and system and/or product development.

Further details on what we use your personal information for

Contact you about or provide you information and materials on: PWS and related conditions; and Soleno’s products, activities, services and events

We will use your personal information to decide what information and materials will be useful or relevant to you, send you the information or materials, and contact you about them. We only do this if you:

• have actively signed-up to receive information from us; or
• are a participant in one of our Patient Support Programs.

You can unsubscribe from Soleno’s communications by managing your preferences through the link accompanying our emails, or emailing us at [email protected].

We always follow applicable direct marketing rules, which means that in some countries we will not send any marketing of our prescription medications.  If you are in the European Economic Area or the UK, where it is required, we will always ask for your consent to provide you with this information. However, our use of your personal information for this purpose is in Soleno’s legitimate interest (as described above).

When we rely on legitimate interest, we conduct an assessment to ensure that your rights are protected and that our marketing does not unfairly affect your privacy.

Responding to your inquiries.

Where you have made an inquiry or requested information, either directly or via a form on our website, we will use your personal information to respond to your inquiry. We may also use your personal information to provide you with other information and materials on PWS and related conditions, as well as Soleno’s products, activities, and business (as described above).

If you are in the European Economic Area or the UK, our use of your personal information for this purpose is in Soleno’s legitimate interest (as described above).

Support decisions concerning the development, marketing and sale of Soleno’s products and services; research and development into PWS and related conditions.

We will use the information you provide to us to support our decisions concerning the future development, marketing and sale of our products and services. We will also use the information provided to support our ongoing research and development activities in respect of PWS and related conditions. This work can be in respect of you, or others.

If you are in the European Economic Area or the UK, our use of your personal information for this purpose is in Soleno’s legitimate interest (as described above). Where the personal information we use:

• includes information concerning your health; or
• reveals your racial or ethnic origin,

our collection and use of this personal information will be based on your explicit consent (which we obtain from you before you provide your personal information).

Assess interest you may have in participating in an educational event or other activities supporting the effective treatment of PWS, such as Patient Advisory Boards and sending you details; enroll and administer participation and/or attendance in events and activities.

Where permitted by applicable laws and codes, we will use your information to:

• assess your likely interest in Soleno’s educational events, meetings or other activities;
• provide you with details about other upcoming events;
• arrange and administer your enrollment and participation, including making payments to you (where applicable).

We may also send you information about our activities, products, and services before, during, and after events, in both digital and printed formats.

If you are in the European Economic Area or the UK, our use of your personal information for this purpose is in Soleno’s legitimate interest (as described above). We always follow applicable direct marketing rules, which means that if you are in the European Economic Area or the UK, where it is required, we will always ask for your consent to provide you with information about our events, activities, products and services. However, our use of your personal information for this purpose is in Soleno’s legitimate interest (as described above).

Information generated from your interaction with our website.

Our website uses cookies and similar technologies to gather information about your interaction with our website, as further detailed in our cookie policy. This information is used to monitor and measure the performance and effectiveness of Soleno’s marketing activity, including website engagement. It is also used to create a profile for targeted on-line and off-line communications and messages concerning Soleno’s products and services (including display ad retargeting).

We will always follow applicable rules regarding the use of these technologies and, where it is required, will first obtain your consent before their use.  If you are in the European Economic Area or the UK, our use of your personal information for these purposes is based on Soleno’s legitimate interests.

Promotion of Soleno’s activities, products and services in digital and printed media.

Provided you have given us your prior consent, we may use still or moving images or quotes captured during your participation in our events, or interviews. These will be used for the purposes of supporting the promotion of our activities, products and services in both digital and printed media. We will provide further information in the agreements or consent forms we give to you.

Enrollment into the Support Program (including eligibility); administration and maintenance of participation.

When you enroll into one of Patient Support Programs, we collect and use your personal information to:

• assess your eligibility to participate in the program;
• enroll you into the program (provided you are eligible);
• administer and maintain your participation in the program;
• provide you with information, education and support in respect of PWS (whether as a patient, parent, or caregiver);
• support you in the co-ordination of you or a patient’s care with healthcare practitioners;
• support you or (if you are a parent or caregiver) the patient you are caring for, obtain medicines for PWS and receive or take those medicines;
• connect you with other patients, parents, and caregivers in support groups and networks.

Wherever necessary, we obtain your consent to use your personal information for these purposes.

If you are in the European Economic Area or the UK, our use of your personal information will always be with your explicit consent, or such other basis as we will communicate to you before you enroll onto the program.

Adverse event and safety reporting

If you have concerns about the quality or safety of our product (whether as a patient, parent or caregiver), you can contact us to report that concern. So that Soleno can fulfil its legal and regulatory requirements in respect of its product, it will need to collect and use information about your concerns and the circumstances of the concern. This will include your personal information or the personal information of the user of our product.

If you are in the European Economic Area or the UK, and the legal obligation we must fulfill does not arise under EU or UK law (respectively), Soleno’s lawful use of personal information is in its legitimate interest. Where the personal information we use:

• includes information concerning your health; or
• reveals your racial or ethnic origin,

our collection and use of this personal information will be based on reasons of public interest in the area of public health.

Overview of how we use the personal information of Healthcare Practitioners (HCPs)

If you are an HCP, we have summarized below how Soleno uses your personal information. How we interact with you and the information you receive from us will depend on which country you practice in.

Personal Information you provide or which we collect from public sources (like LinkedIn or on-line publications) or third parties (like event providers)	What it is used for and why we collect it
Educational Resources and inquiry management Name, title, employing organization (employer), email address, address, phone number.	Provide information and materials concerning Soleno’s activities, products and services, including through in-person visits.
	Responding to your inquiries whether you contact us directly or fill in an inquiry form on our website.
HCP Verification Name, date of birth, title, employing organization, working location, employment history, education and training, National Provider Identifier Number, State or other Medical License Number.	Complete verification of HCP qualifications and credentials for determining engagement parameters and limitations.
Marketing and engagement Name, email address, address, education history, professional qualifications, biography, HCP designation and registration number (such as National Provider Identifier), details of personal circumstances as an HCP providing care for patients, employment history, information available from publicly available sources (including LinkedIn, social media, academic rolls), responses to surveys.	Profile you for targeted HCP engagement activity, communications and messages concerning Soleno’s products, services and events.
	Contact you about, or send you information on, Soleno’s activities, products, and services, based on your expertise and interests.
	Provide market insights for Soleno product and service development, and associated activities, such as HCP engagement, marketing and communications.
	Monitor and measure the performance and effectiveness of Soleno’s marketing activity, including website engagement.
HCP Consultants: Prospective and recruited HCPs Name, email address, address, education history, professional qualifications, biography, HCP designation and registration number (such as National Provider Identifier), details of personal circumstances as an HCP providing care for patients, employment history, information available from publicly available sources (including LinkedIn, social media, academic rolls). Renumeration administration: Name, primary business address, bank details, amount of payment or transfer of value to HCP, form of payment, nature of payment.	Identify prospective HCP Consultants, evaluate HCP Consultant candidates, engage with selected HCP Consultants (outreach), contract with the HCP Consultants.
	Management, coordination and supervision of HCP engagement, including in respect of (i) medical education; (ii) public speaking; (iii) publication authorship; (iv) media engagement; (v) product endorsements (where permitted); (vi) regulatory support; (vii) market research; (viii) consulting (including advisory boards); (ix) research and collaboration; and (x) patient advocacy.
	Administration and recording of payment to HCP Consultants of remuneration in respect of services provided.
Regulatory obligations: Practitioner payments Name, primary business address, specialty, National Provider Identifier, State Professional License Number, amount of payment or transfer of value to practitioner, form of payment, nature of payment, ownership or investment interest in Soleno held by practitioner. Adverse Event and Safety Reporting Full name of the reporting HCP, contact information (email, phone), country, HCP designation (e.g., MD, RN), NPI, Professional license number, Institution or practice name.	Meet our regulatory obligations under applicable laws and codes.
Surveys Responses provided to surveys, including name, position, professional qualifications, biography, details of personal experiences as an HCP or researcher in the context of PWS or other disease states, or as a patient advocate, caregiver, parent or relation of a person with PWS.	Research and development into PWS and related conditions, as well as future Company pipeline disease states.
	Support decisions concerning the development, marketing, and sale of Soleno’s products and services.
Medical Education, Event Participation (Continuing Medical Education, webinars, seminars and conferences) Name, email address, position, professional qualifications, biography, information available from publicly available sources (including LinkedIn, social media, academic rolls), details of personal circumstances as an HCP providing care in respect of PWS and other disease states, access requirements, dietary requirements. Moving and still images while recording events.	Assess interest you may have in participating in an educational event and sending you details.
	Enroll and administer participation and/or attendance in events.
	Provide information concerning the event (pre, during and post-event) and Soleno’s activities, products and services.
	Promotion of Soleno’s activities, products and services in digital and printed media.
	Meet our regulatory obligations under applicable laws and codes, such as the US Sunshine Act or the ABPI Code of Practice.
Adverse event and safety reporting Name of the reporter, contact information (email, phone), professional and practice details, country of residence and/or practice.	Meet legal and regulatory requirements in respect of the safety and quality of Soleno’s products

Further details on what we use your personal information for

Responding to your inquiries, and contacting you about or providing you information and materials on: PWS and related conditions; and Soleno’s activities, products and services

We will use your personal information to respond to your inquiries, send you relevant information and materials, and then contact you about them.  Depending on the nature of your inquiry, we may need to obtain further information from you (such as HCP designation, institution or proactive name, NPI or professional license details) so that we can consider your inquiry and ensure we provide you with the correct information.

We will send you this and any further information we believe may be of interest to you as it is in our legitimate interest to do so. When we rely on legitimate interest, we conduct an assessment to ensure that your rights are protected and that our marketing does not unfairly affect your privacy. Where required, we will ask for your consent to send this information to you.

You can unsubscribe from Soleno’s communications by managing your preference through the link accompanying our emails or emailing us at [email protected].

Marketing and engagement

As part of our marketing and engagement activities, we will use your personal information to

• create a profile of you so we can better assess the information and materials to send to you;
• Provide market insights for Soleno product and service development, and associated activities, such as HCP engagement, marketing and communications; and
• Monitor and measure the performance and effectiveness of Soleno’s marketing activity, including website engagement.

If you are in the European Economic Area or the UK, our use of your personal information is in Soleno’s legitimate interest for the purposes described above. Where it is required, we will seek your consent for the use of your personal information for these purposes.

Identify you as an HCP Consultant and engage you; and manage, coordinate and supervise your engagement as an HCP Consultant, including payment of remuneration.

We will use your personal information to

• identify, evaluate, engage and establish contact with you as a prospective HCP Consultant; and
• establish relevant communication and ensure that activities such as medical education, public speaking, publication authorship, media engagement, product endorsement (where permitted), regulatory support, market research, consulting and patient advocacy are managed effectively and in line with legal and regulatory requirements;
• pay expenses in respect of the services you provide.

If you are in the European Economic Area or the UK, our use of your personal information is in Soleno’s legitimate interest for the purposes described above. Where in connection with your engagement as an HCP Consultant your personal information is used to fulfill a legal obligation arising under EU or UK law (respectively), Soleno’s lawful use of personal information is to meet that legal obligation. Where the payment of expenses is made in accordance with a contract we may have with you, Soleno’s lawful use of personal information in that respect is to meet our contractual obligations to you.

Meet our regulatory obligations under applicable laws and codes

Where required, we collect and use your personal information to comply with regulatory and legal requirements and ensure compliance with applicable laws, industry standards and ethical guidelines.  This includes:

• laws such as the US Sunshine Act and standards such as the ABPI Code of Practice; and
• adverse event and safety reporting requirements.

If you are in the European Economic Area or the UK, and the legal obligation we must fulfill does not arise under EU or UK law (respectively), Soleno’s lawful use of personal information is in its legitimate interest.

Surveys – support decisions concerning the development, marketing and sale of Soleno’s products and services; research and development into PWS and related conditions;

We will use the information you provide to us in surveys to support our decisions concerning the future development, marketing and sale of our products and services. We will also use the information to support our ongoing research and development activities in respect of PWS and related conditions. This work can be in respect of you, or others.

If you are in the European Economic Area or the UK, our use of your personal information for this purpose is in Soleno’s legitimate interest (as described above).

Assess interest you may have in participating in an educational event and sending you details; enroll and administer participation and/or attendance in events.

We may collect your business contact information (such as email, phone number, address, and job title) from you directly or from publicly available sources like LinkedIn. If you attend an event hosted by us or a third party, we may receive your details from the event organizer.

Where permitted, we will use your information to:

• assess your likely interest in educational events;
• provide you with details about other upcoming events;
• arrange and administer your enrolment and participation.

We may also send you information about our activities, products, and services before, during, and after events, in both digital and printed formats.

Our communications comply with applicable laws and codes, such as the US Sunshine Act and the ABPI Code of Practice.

If you are in the European Economic Area or the UK, our use of your personal information for these purposes is in Soleno’s legitimate interest (as described above).

Promotion of Soleno’s activities, products and services in digital and printed media.

Provided you have given us your prior consent, we may use still or moving images that we have captured during your participation in our events, or interviews for the purposes of supporting the promotion of our activities, products and services in both digital and printed media. We will provide further information in the agreements or consent forms we give to you.

Responding to your inquiries.

Where you have made an inquiry or requested information, either directly or via a form on our website, we will use your personal information to respond to your inquiry. We may also use your personal information to provide you with other information and materials on PWS and related conditions, as well as Soleno’s products, activities, and business (as described above).

If you are in the European Economic Area or the UK, our use of your personal information for this purpose is in Soleno’s legitimate interest (as described above).

Additional details – for all uses of personal information

Other uses of your personal information

Enforcing legal rights

We may use your personal information to protect our legal rights or enforce agreements, including for purposes such as complying with legal obligations, resolving disputes, or defending ourselves in legal claims.

Administration, quality, and training

We will use your personal information to:

• help administer our business (including in accordance with legal or other obligations we must meet);
• manage our relationship with you;
• maintain quality standards; and
• design and deliver internal training.

Regulatory requirements

Soleno is subject to many legal and regulatory requirements in respect of its activities, worldwide. We will use your personal information wherever required so we can fulfill these requirements.

If you are in the European Economic Area or the UK, our use of your personal information for the purposes described above is in Soleno’s legitimate interests. Where our collection and use of your personal information is used to fulfill a legal obligation arising under EU or UK law (respectively), Soleno’s lawful use of personal information is to meet that legal obligation.

Who else gets your personal information?

Soleno does not disclose your personal information for a business purpose except as set out in this Privacy Statement. Your personal information is never otherwise sold or shared to third parties.

To help us provide our solutions and services, the personal information described above is disclosed to third parties who provide services to us, including:

• information technology and information services providers;
• other third-party service providers; and
• professional and other third-party advisers.

These third parties can only use your personal information to provide their services to us or to support the delivery of our services to you. They must follow our instructions, and they are not permitted to sell or share your personal information.

Your personal information is not disclosed to anyone else.

In certain circumstances, we may be obliged to disclose your personal information to a public authority in response to a lawful request or to respond to legal process. We will only make such disclosure to the extent such request is lawful.

If you do not wish us to disclose your information to a third party or use it for a purpose that is materially different from the purposes for which it was originally collected or subsequently authorized by you, you can inform us by using the mechanisms detailed in “Your rights” below.

How long do we keep your personal information?

We will only keep your personal information for as long as we are legally required, or if longer, for the period the personal information is needed for the purposes we have collected it.

Transfers of personal data

Soleno is located in the United States, Europe, and the United Kingdom. Your personal information will be transferred to these locations, but only for use by Soleno for the purposes described in this privacy statement. In each case, these transfers are subject to adequate safeguards as prescribed by law.

If you wish to receive further information on these transfers and the safeguards in place, please contact us at [email protected].

Contacting Soleno

Soleno Therapeutics

The controllers of your personal information are identified below. You can at any time contact Soleno in respect of the use of your personal information:

Soleno Therapeutics Inc, 100 Marine Parkway, Suite 400, Redwood City, CA 94065

Soleno Therapeutics UK Ltd, Suite 4, 7^th Floor, 50 Broadway, London, UK, SW1H 0DB

Soleno Therapeutics Europe Ltd. Suite 10151, 26 Upper Pembroke Street, Dublin 2, Dublin, Ireland

The EU representative for Soleno Therapeutics Inc in:

• the UK, is Soleno Therapeutics UK Ltd
• the EU, is Soleno Therapeutics Europe Ltd

You can also contact us by email: [email protected]

Our Data Protection Officer

Soleno has designated a Data Protection Officer. The Data Protection Officer can be contacted by emailing: [email protected]

Your Rights

Accessing, deleting, rectifying, and moving your personal information

Depending on the country or state laws that apply to our collection and use of your personal information, you may have the right to:

• access your personal information and have disclosed to you what personal information we have collected, used, shared or sold about you, and for what purposes;
• object to our processing of your personal information where our collection and use is based on our legitimate interests;
• require us to delete your personal information;
• opt-out of the sale of your personal information;
• rectify any personal information we hold that is incorrect; and/or
• have your personal information transmitted to another data controller.

Where applicable, if you want to exercise these rights, please let us know using the contact mechanisms identified above. You may ask you to provide sufficient information to verify and complete your request. Subject to the rights you have, and to any legal or other requirements, we will complete your request within thirty days.

Withdrawing consent

Wherever you have provided consent for the collection and use of your personal information you may withdraw that consent at any time using the mechanisms informed to you at the time your consent was provided, or by emailing: [email protected]. If you withdraw your consent, we will not be able to further use your personal information and this will affect how we can interact with you.

California residents

We have described above the ways in which your sensitive personal information will be used by Soleno. If you wish Soleno to limit the use of your sensitive personal information, please submit your request to [email protected]

Lodging a complaint – European Union, United Kingdom and Switzerland

You can at any time complain about our processing of your personal information with the following data protection authorities:

Europe

You can obtain details of supervisory authorities in each member state at:

www.edpb.europa.eu/about-edpb/about-edpb/members_en

United Kingdom

UK’s Information Commissioner’s Office.

You can obtain contact details at: www.ico.org.uk

Switzerland

Where applicable, you can contact the Federal Data Protection and Information Commissioner.

You can obtain contact details at: https://www.edoeb.admin.ch

This statement was published on 07 January 2024. If you wish to see prior versions of this statement, please contact us.