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Privacy Statement

Updated: January 1, 2020

1. PURPOSE

1.1. At Strongbridge Biopharma (“Strongbridge”) privacy is of great concern. Strongbridge and its operating divisions, subsidiaries, affiliates and branches (collectively, “Strongbridge”, “we” or “us”) are sensitive to privacy issues, and it is important to us to protect the information provided to us. Accordingly, Strongbridge provides this privacy policy to inform you about our online and certain offline information practices, the kinds of information we may collect, how we intend to use and share that information, and how you can correct or change such information (“Privacy Policy”). Strongbridge is fully committed to protecting the privacy of and personal information related to all individuals whom we interact with – including patients, members of the public, employees, regulatory and healthcare professionals, and business partners. We will not sell, trade, exchange, or otherwise make available any personal information to any other company or organization not directly affiliated with Strongbridge.

2. PERSONAL INFORMATION STRONGBRIDGE COLLECTS

2.1. Strongbridge has collected the following categories of personal information within the 12 months preceding the date this privacy policy was last updated:

2.1.1. Identifiers (e.g., name, email address, postal address, IP address, cookie ID)

2.1.2. Categories of personal information described in California Civil Code §1798.80(e) (e.g., signature, physical characteristics, telephone number, Social Security number, financial information, medical information, health insurance information)

2.1.3. Protected classification characteristics under California or federal law

2.1.4. Commercial information (e.g., information about products, treatments and health conditions that are of interest to you)

2.1.5. Internet or other electronic network activity information

2.1.6. Professional or employment-related information (e.g., job title, resume, educational information, professional qualifications and work experience)

2.1.7. Education information

2.1.8. Inferences drawn from other personal information (e.g., your communication preferences)

2.1.9. Strongbridge uses software programs to analyze traffic to this website. These programs collect aggregate data, but do not collect personal information.

3. SOURCES OF PERSONAL INFORMATION

3.1. In most cases, Strongbridge receives personal information directly from you that you voluntarily submit to us. We will ask for personal information when you interact with us through our website, such as signing up for newsletters and announcements, or filling out an inquiry form. Strongbridge may collect additional information from other sources, such as information to verify professional status, identity and specialty of Health Care Professionals, communications or products and/or services. Information may automatically be gathered about you using our website, such as your IP address or how you navigate around the website. See Cookies below.

3.2. Strongbridge collects personal information from the following categories of sources:

Personal Information Sources
Identifiers Directly and indirectly from you, service providers
Categories of personal information described in California Civil Code §1798.80(e) Directly from you
Protected classification characteristics under California or federal law Directly from you
Commercial information Directly and indirectly from you, service providers
Internet or other electronic network activity information Indirectly from you, service providers
Professional or employment-related information Directly from you
Education information Directly from you
Inferences Indirectly from you, service providers

4. WHY STRONGBRIDGE USES YOUR PERSONAL INFORMATION

4.1. Strongbridge will only use your information for purposes permitted by applicable laws, which may vary depending on where you live. Strongbridge may use your personal information for business purposes, such as:

  • To respond to your requests for information, products and services, and communicate with you about those requests;
  • To provide you with general health information (such as information on certain conditions);
  • To comply with legal and/or regulatory requirements;
  • If you have a business or professional relationship with Strongbridge, to develop that relationship with you;
  • To consider your employment, if you apply for a job with Strongbridge;
  • And, for product safety, such as adverse event reporting, product complaint reporting, or to communicate product safety information to you.

4.2. Strongbridge collects these categories of personal information for the following business purposes:

Personal Information Purposes
Identifiers To respond to your requests for information, products and services, and communicate with you about those requests; provide you with general health information; develop business or professional relationship with you; consider your employment; for product safety
Categories of personal information described in California Civil Code §1798.80(e) To respond to your requests for information, products and services, and communicate with you about those requests; provide you with general health information; develop business or professional relationship with you; consider your employment; comply with legal and/or regulatory requirements; for product safety
Protected classification characteristics under California or federal law To consider your employment; comply with legal and/or regulatory requirements
Commercial information To respond to your requests for information, products and services; for product safety
Internet or other electronic network activity information To respond to your requests for information, products and services; for product safety
Professional or employment-related information To consider your employment; develop business or professional relationship with you
Education information To consider your employment
Inferences To respond to your requests for information, products and services

4.3. Legal Basis for Using Information: Strongbridge processes your individual information where it is reasonably required to pursue its legitimate business aims and as required by law.

4.4. Special Categories of Data: In addition to the above, where Strongbridge processes special categories of data about individuals in certain jurisdictions (including the European Economic Area), for example data about individuals’ health, ethnicity or genetic information – it shall only do so in according with the obligations of the law.

5. HOW STRONGBRIDGE DISCLOSES YOUR PERSONAL INFORMATION

5.1. Strongbridge will only disclose your personal information in accordance with applicable laws. Strongbridge may disclose your personal information:

5.1.1. To its subsidiaries for the purposes set forth in this privacy policy, public/regulatory authorities/governmental bodies, third parties that provide services to Strongbridge (such as assisting in our clinical trials and studies), and business partners; and

5.1.2. Where requested under legal process or otherwise required by law, when we believe disclosure is necessary or appropriate to comply with regulatory requirements or to protect the safety, rights or property of our customers.

5.2. Strongbridge does not and will not sell personal information and therefore does not sell personal information of minors under 16 years of age without affirmative authorization. Strongbridge also does not share or otherwise distribute personal information with third parties for marketing purposes.

5.3. Service providers for Strongbridge are bound by law or contract to protect your personal information and only use the information in accordance with our instructions.

6. SECURITY MEASURES TAKEN TO PROTECT YOUR PERSONAL INFORMATION

6.1. Strongbridge uses appropriate technical and procedural measures to safeguard your personal information. We take reasonable steps to protect your information from loss, misuse, unauthorized access or disclosure, alteration or destruction.

7. HOW LONG STRONGBRIDGE OBTAINS YOUR PERSONAL INFORMATION

7.1. Strongbridge retains your personal information for no longer than is necessary for the specific business purpose or purposes for which it was collected. Information may be obtained longer where applicable laws or regulations require or allow Strongbridge to do so.

8. AUTOMATED DECISION MAKING

8.1. Strongbridge does not undertake decisions based solely on automated processing, including profiling of individuals, unless we inform you otherwise.

9. PATIENTS AND TRIAL PATIENTS

9.1. Strongbridge processes the information of patients that use Strongbridge treatments and clinical trial participants in trials linked to Strongbridge drugs. In addition, Strongbridge may have access to patient information through collaboration with third parties (e.g. genetic data). Strongbridge may transfer the clinical trial data outside of your country (e.g. to the United States) to process the information or submit the information to competent authorities.

10. LINKS TO THIRD PARTY WEBSITES

10.1. This Privacy Policy only addresses the use and disclosure of data by Strongbridge. Links may be provided to outside websites for third parties who have their own privacy policies, use and disclosure practices. Strongbridge encourages you to familiarize yourself with the privacy policies provided by all third parties, prior to providing them with personal information. We require that our third-party service providers and channel partners agree to keep all confidential information we share with them and to use the information only to perform their obligations in the agreements we have in place with them. These third-party service providers and channel partners are expected to maintain privacy and security protections that are consistent with Strongbridge’s privacy and information security policies.

11. CHILDREN

11.1. This website is not directed for use to individuals under the age of thirteen (13). Strongbridge does not knowingly collect personal data from children under the age of 13. If we learn we have collected or received personal information from a child under 13 without verification of parental consent, we will delete it.

12. USE OF COOKIES

12.1. Strongbridge uses technology known as “cookies” on our website. A cookie is a small data file that is placed on your devise, which we use to better understand, customize and improve user experience on our website. Some web browsers (including some mobile web browsers) provide settings that allow you to control or reject cookies or to alert you when a cookie is placed on your computer, tablet or mobile device. Although you are not required to accept cookies, if you block or reject them, you may not have access to all features available through our services. For more information, visit the help page for your web browser or see http://www.allaboutcookies.org. Please note that if you disable your web browser’s cookies and other technologies, certain features of our website and services will be disabled and you will limit the functionality we can provide when you visit our website.

13. CROSS BORDER TRANSFERS

13.1. This website is controlled and operated by us from the United States and is not intended to subject us to the laws and jurisdictions of any other state, country, or territory other than that of the United States. Any information you provide to Strongbridge through the use of the Site may be stored and processed, transferred between and accessed from the United States and other countries which may not guarantee the same level of protection of personal data as the one in which you reside. However, Strongbridge will handle your personal data in accordance with this privacy policy regardless of where your personal data is stored or accessed.

14. CHANGES TO THIS PRIVACY POLICY

14.1. Strongbridge may periodically update this privacy policy by posting any revisions to this policy statement. Any changes will be effective when we post the revised policy. Where any material revisions are made regarding the personal information we have collected, Strongbridge will provide notice and/or obtain your consent, as appropriate.

15. INDIVIDUAL RIGHTS

15.1. Under applicable law, you may have a right to request a copy of information about you held by Strongbridge. You may also have the right to revise, correct, or delete such information, subject to limited legal and regulatory restrictions.

16. CALIFORNIA PRIVACY RIGHTS

16.1. If you live in California, you have the right to: (1) request that we disclose what personal information we collect, use, disclose, and sell; (2) request deletion of personal information; (3) opt-out of the sale of personal information; and (4) not receive discriminatory treatment for exercising these rights. Only you, or someone legally authorized to act on your behalf, may make a verifiable consumer request related to your personal information. In order to designate an authorized agent to make a request on your behalf, you must provide a valid power of attorney, the requester’s valid government-issued identification, and the authorized agent’s valid government issued identification. We also reserve the right to confirm your current California residency. We cannot process your request if you do not provide us with sufficient detail to allow us to understand and respond to it. In certain cases, we may be declining your request as permitted by law.

16.1.1. Requests to Know – you have right to request the following information:

a) Specific pieces of personal information Strongbridge has collected about you;

b) Categories of personal information Strongbridge has collected about you, disclosed about you for a business purpose, or sold;

c) Categories of sources from which the personal information is collected;

d) Categories of third parties with whom Strongbridge shares or to whom Strongbridge sells personal information; and

e) The business or commercial purpose for collecting and selling personal information.

To make such a request, please contact:

By email: [email protected]

By phone: Toll-free at (844) 826-0055

16.1.2. Requests to Delete – you have the right to request that we delete personal information about you that we collected and maintain, subject to certain exceptions. We will need to confirm your identity to process your requests to exercise your information, access or deletion rights. As a part of this process, government identification may be required. Consistent with California law, you may designate an authorized agent to make a request on your behalf. In order to designate an authorized agent to make a request on your behalf, you must provide a valid power of attorney, the requester’s valid government-issued identification, and the authorized agent’s valid government issued identification. We also reserve the right to confirm your current California residency. We cannot process your request if you do not provide us with sufficient detail to allow us to understand and respond to it. In certain cases, we may be declining your request as permitted by law. Once we verify your request, we will delete and direct our service providers to delete your personal information, unless an exception applies.

To make such a request, please contact:

By email: [email protected]

By phone: Toll-free at (844) 826-0055

17. CONTACT STRONGBRIDGE

Customers may contact Strongbridge with any questions, concern, or inquiries about this Privacy Policy or company data. If you would like to make an inquiry or formal complaint, please contact Strongbridge at the following mailing address or email.

Strongbridge Biopharma plc.

Attention: Chief Compliance Officer

900 Northbrook Drive

Trevose, PA 19087

[email protected]

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Indication and Important Safety Information

What is KEVEYIS?

KEVEYIS (pronounced keh-VAY-iss) (dichlorphenamide) is a prescription drug used to treat primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and other similar diseases.

What should you tell your healthcare provider before taking KEVEYIS?

Tell your doctor if you are allergic to dichlorphenamide or other sulfa drugs; if you take high doses of aspirin, or if you have lung or liver disease; if you are pregnant, plan to become pregnant, or are breastfeeding or plan to breastfeed.

What should you know about KEVEYIS?

  • Severe allergic and other reactions have happened with sulfonamides (drugs such as KEVEYIS) and have sometimes been fatal. Stop taking KEVEYIS at the first sign of skin rash, swelling, difficulty breathing, or any other unexpected side effect or reaction, and call 911 right away.
  • Tell your healthcare provider if you take aspirin or if another healthcare provider instructs you to begin taking aspirin. High doses of aspirin should not be taken with KEVEYIS.
  • KEVEYIS can cause your body to lose potassium, which can lead to heart problems. Your healthcare provider will measure the potassium levels in your blood before you start treatment and at certain times during treatment.
  • Tell your healthcare provider about all other prescription and over-the-counter medicines you take, including supplements, as some medicines can interact with KEVEYIS.
  • While taking KEVEYIS, your body may produce too much acid or may not be able to remove acid from the body. Your healthcare provider may run tests on a regular basis to check for signs of acid buildup.
  • KEVEYIS may increase your risk of falling. Tell your healthcare provider right away if you experience a fall while taking KEVEYIS.
  • The risks of falls and acid buildup are greater in elderly patients.
  • It is not known whether KEVEYIS is safe or effective for people younger than 18 years of age.

What are the most common side effects with KEVEYIS?

The most common side effects are a feeling of numbness, tingling or burning (“pins and needles”) in the toes, feet, hands or fingers; trouble with memory or thinking; feeling confused; and unpleasant taste in the mouth.

These are not all of the possible side effects of KEVEYIS. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.