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Privacy Policy

Dompé is a biopharmaceutical research and production company. This page applies to Dompé, its operating divisions, subsidiaries, affiliates and branches including in the United States, including any additional subsidiary, affiliate or branch Dompé may subsequently form. This page describes how Dompé processes personal information of the users in the course of its business, including on its websites, such www.dompe.com, https://oxervate.com/, and other product websites listed at https://www.dompe.com/en/products (the “Websites”), any mobile websites or applications we provide, as well as offline offerings, for instance in the course of clinical testing or our interactions with health care professionals (collectively, the “Services”). This Policy also explains how Dompé may use and disclose such information, as well as your ability to control certain uses of it.

QUICK GUIDE TO CONTENTS
  1. INFORMATION WE COLLECT
    1. Information You Provide
    2. Information Automatically Collected
    3. Information Collected from Other Sources
    4. Notice Regarding Third-Party Websites, Social Media Platforms and Software Development Kits.
    5. Combination of Information
  2. OUR INFORMATION USE
    1. Use By or For Dompé
    2. Interest-Based Advertising
  3. INFORMATION WE SHARE WITH OTHERS
  4. YOUR CHOICES AND OPT-OUTS
    1. Cookies, Tracking Options, and California Do Not Track Disclosures
    2. Interest-Based Advertising Choices
    3. Unsubscribing from Our Marketing Communications
    4. Updating Your Information
    5. Your GDPR Rights
  5. YOUR CALIFORNIA PRIVACY RIGHTS
  6. CHILDREN'S PRIVACY
  7. DATA RETENTION AND SECURITY
  8. INTERNATIONAL TRANSFER
  9. REVISIONS TO THIS PRIVACY POLICY
  10. HOW TO CONTACT US
  11. Addendum: California Privacy Rights

1. INFORMATION WE COLLECT

There are several ways we may obtain information about you, including through (A) information you provide to us directly; (B) information that we automatically collect; and (C) information we receive from third parties. This includes data that identifies you personally whether directly (i.e., your name) or indirectly (i.e., information about your online use).

A. Information You Provide

The categories of personal information we collect depend on whether you are a visitor of our website, a health care professional, or a participant in a clinical trial, and the requirements of applicable law.

Your Interactions with Our Websites. Dompé collects information from you when you choose to share it with us through our Services. This may include when you use our Site, register online through the Site, request information from us, sign up for our email list, request customer support, or otherwise communicate with or contact us.

  • For site visitors, the information we collect may include your first and last name, your reason for contacting us, your zip code, and your email.
  • For health care professionals, if you sign up to receive additional information via email, we will collect your full name, email address, zip code, type of physician, and institution (optional).

Clinical Trial Participation. In connection with your participation in clinical trials and where we are required to by legal requirements (such as adverse event reporting requirements), we may collect driver’s license, passport number, tax identification number, and health information related to your medications, medical history medical insurance details, physical and mental health conditions, diagnoses, treatments, genetic information, and family medical history. We may also collect and store investigator, sponsor, contract research organization (“CRO”), and institutional employee contact information, including names, addresses, phone and fax numbers and email addresses. We collect such information only where you have provided your consent to disclose that information to us, as required by law.

Commercial. We may collect various information from healthcare professionals as part of marketing activities to healthcare professionals, including first name, last name, age, gender, home address, home phone number, medical specialization, professional qualifications, license number and scientific society membership number.

Regulatory. We are also obligated to collect certain Personal Information to comply with regulatory requirements, including information relating to any adverse effects you may have experienced when using our products.

[Conferences, Trade Shows, and Other Events. We may attend conferences, trade shows, and other events where we collect personal information from individuals who interact with or express an interest in Dompé and/or our Services. If you provide us with any information at one of these events, we will use it for the purposes for which it was collected.]

Surveys. We may contact you to participate in surveys. If you decide to participate, you may be asked to provide certain information, which may include personal information.

Social Media Content. We may offer forums, blogs, or social media pages. Any content you provide on these channels will be considered “public” and is not subject to privacy protections.

B. Information Automatically Collected

Whenever you visit or interact with the Site, we, as well as any of our third-party service providers, may use a variety of technologies such as cookies, web beacons, pixel tags, log files, local shared objects (Flash cookies), HTML5 cookies, or other technologies to automatically or passively collect certain information about your online activity.

Please note that we may automatically collect the following information about you:

  • Computer or Device Information. We may automatically collect your Internet Protocol (“IP”) address, MAC Address, mobile carrier, or other unique identifier or information from the computer, mobile device, tablet or other device that you use to access the Site, including but not limited to your browser type, device type, operating system, software version, phone model, phone operating system, and the domain name from which you accessed the Site.
  • Usage Information. We may collect information about your use of the Site, including the date and time you visit the Site, the areas or pages of the Site that you visit, the amount of time you spend viewing or using the Site, the number of times you return to the Site, other click-stream or site usage data, emails that you open, forward or click-through to our Site, and other sites that you may visit.
  • Location Information. We collect general information about where traffic on our site is coming from around the world. This is used at an aggregate level that does not identify individual users to create reports to better understand our engagement with visitors to the site. Location information at an individual level may be used for narrowly tailored efforts for our products or research activities.

  • Our Third Party Service Providers. We, as well as third parties that provide content, advertising, or other functionality on the Services, may use cookies, pixel tags, local storage, and other technologies (“Technologies”) to automatically collect information through the Services. Technologies are essentially small data files placed on your computer, tablet, mobile phone, or other devices that allow us and our partners to record certain pieces of information whenever you visit or interact with our Services.
  • Use of Third Party Analytic Technologies. We may use third parties’ analytics and tracking tools, including Google Analytics, to better understand who is using the Site, how people are using the Site, and how to improve the effectiveness of the Site and related content. These tools may use technology such as cookies, web beacons, pixel tags, log files, Flash cookies, HTML5 cookies, or other technologies to automatically collect and store certain information. They may also combine information they collect from your interaction with the Site with information they collect from other sources.

Our use of cookie technologies are listed below:



SUMMARY TABLE OF COOKIES

COOKIE NAME DEFAULT EXPIRY PERIOD COOKIE DESCRIPTION
HP3_USER 60 minutes This cookie is used to retain some user data and their navigation session
ASP.NET_SessionID At the end of the session A session cookie used to keep the navigation session anonymous
__utma 2 years A Google Analytics cookie used to count the number of visits
__utmb 30 minutes A Google Analytics cookie indicating a new browsing session. It is refreshed upon every service connection.
__utmz 6 months A Google Analytics cookie that identifies the connection source
__utmc At the end of the session A Google Analytics cookie used to count the number of visits
__utmv 2 years A Google Analytics cookie used to assess the Website operation
dc_user_settings DocCheck cookie
doccheck_scu_data DocCheck cookie
doccheck_user_id DocCheck cookie
PHPSESSID This cookie is used to retain some user data and their navigation session
__atuvc An AddThis cookie used to allow visitors to share contents on different platforms focusing on user connections(Facebook, Twitter, email, and so on). It stores the number of shares for a page.
__atuvs A cookie associated to the AddThis widget and typically used to allow visitors to share contents on different platforms focusing on user connections (Facebook, Twitter, email, and so on).


C. Information Collected From Other Sources

We may acquire information from other sources as follows:

  • From trusted third-party sources to update or supplement the information that you provide or that we collect automatically. This includes, for example, information from public databases or data aggregators (which may include information to validate or update the information we collect from or about you).
  • From our partners and service providers (including, for example, business partners, analytics vendors, and search information providers).
  • [From third-party login services or social networking sites you use to access our Services. This information includes any information you have made public via your privacy settings, such as your name, location, gender, birth date, email, or contacts. This supplemental information allows us to verify information you have provided to us and to enhance our ability to provide you with information about our business, products, and Services.]

We may use this information to help us maintain the accuracy of the information we collect, target our communications so that we can inform you of products, services or other offers that may be of interest to you, and for internal business analysis or other business purposes.

D. Notice Regarding Third-Party Websites, Social Media Platforms, Application Programming Interfaces and Software Development Kits.

The Services may contain links to other websites, and other websites may reference or link to our website or other Services. These other websites are not controlled by us. We encourage our users to read the privacy policies of each website and application with which they interact. We do not endorse, screen or approve and are not responsible for the privacy practices or content of such other websites or applications. Visiting these other websites or applications is at your own risk.

Our Services may include publicly accessible blogs, forums, social media pages, and private messaging features. By using such Services, you assume the risk that the personal information provided by you may be viewed and used by third parties for any number of purposes. In addition, social media buttons such as Facebook, Twitter, and LinkedIn (that might include widgets such as the “share this” button or other interactive mini-programs) may be on our site. These features may collect your IP address, which page you are visiting on our site, and may set a cookie to enable the feature to function properly. These social media features are either hosted by a third party or hosted directly on our site. Your interactions with these features apart from your visit to our site are governed by the privacy policy of the company providing it.

We may use third-party Application Programming Interfaces (“APIs”) and Software Development Kits (“SDKs”) as part of the functionality of our Services. APIs and SDKs may allow third parties including analytics and advertising partners to collect your personal information for various purposes including to provide analytics services and content that is more relevant to you. For more information about our use of APIs and SDKs, please contact us as set forth below.

E. Combination of Information

We may combine the information we receive from and about you, including information you provide to us and information we automatically collect through our Site, as well as information collected offline, and from third party sources.

2. OUR INFORMATION USE

A. Use by or for Dompé

Dompé may use the information we collect from and about you for any of the following purposes:

  • To respond to your inquiries and contact and communicate with you when necessary;
  • To review the usage and operations of our Site and conduct analysis to enhance or improve our content, products, and services;
  • To provide you with advertising on the Site, via mail or email, or across other websites, mobile applications, social media or online services;
  • To contact you, including by mail or email, with information, newsletters and promotional materials from Dompé or on behalf of our affiliates, and to request information from you relating to your use of our products and services;
  • To use your data in an aggregated non-specific format for analytical and demographic purposes;
  • To address problems with the Site or our business, and to protect the security or integrity of the Site and our business;
  • For other purposes disclosed at the time you provide your information or otherwise with your consent.

Research and Development. We may use personal information to create non-identifiable information that we may use alone or in the aggregate with information obtained from other sources, in order to help us to optimally deliver our existing products and services or develop new products and Services.

De-Identified or Aggregated Information. We may use and share de-identified or aggregated information within the Dompé group of companies or with third parties for public heal-h, research, analytics, or any other legally-permissible purpose.

Regulatory Purposes. We may use personal information to comply with regulatory or legal requirements, including to investigate, track, and/or report on adverse events or effects.

B. Interest-Based Advertising

We may use third parties to measure and target advertisements for us about our products and services that are tailored to your online interests. We allow these third-party companies to use cookies, web beacons, pixel tags and similar technologies to collect certain data and other information about your online activity. This information is used to display advertisements for Dompé on the Site or across other websites that you visit.

For information on your choices with respect to interest-based ads, see the “Interest Based Advertising Choices” section below.

3. INFORMATION WE SHARE WITH OTHERS

Except as provided below, we will not disclose, sell, or rent any of your information to any third parties. We may share the information we collect from and about you with the following parties:

  • Affiliates: We may share your information with Dompé affiliates and subsidiaries bearing the Dompé brand for business, operational, promotional and marketing purposes, Dompé farmaceutici S.p.A. in Italy may process the information for administrative, marketing, and organizational purposes as data controller (as defined under art. 4 of the EU General Data Protection Regulation n. 2016/679, "GDPR"), in order to coordinate and supervise the activity carried out by its subsidiaries, including Dompé US and other Dompé subsidiaries. Dompé farmaceutici S.p.A. will act in compliance with the obligations set forth under the GDPR.
  • Business Partners: Dompé may also provide personal information to business partners with whom we may jointly offer products or services, or whose products or services we believe may be of interest to you. In such cases, our business partner’s name will appear, along with Dompé’s. Dompé requires our business partners to agree in writing to maintain the confidentiality and security of personal information they maintain on our behalf and not to use it for any purpose other than the purpose for which Dompé provided them.
  • Service Providers: We may share your information with third party service providers that provide business, professional or technical support functions for us, help us operate our business and the Site, provide analytics, or administer activities on our behalf.
  • Legal Matters; Safety: We may access and disclose your information to respond to subpoenas, judicial processes, or government requests and investigations, or in connection with an investigation on matters related to public safety, as permitted by law, or otherwise as required by law. We may disclose your information to protect the security of our Site, servers, network systems, and databases. We also may disclose your information as necessary, if we believe it is necessary to protect our legal rights, or the rights of any third party.
  • Sale or Transfer of Business or Assets: If we are involved in a merger, acquisition, financing due diligence, reorganization, bankruptcy, receivership, purchase or sale of assets, or transition of service to another provider, then your information may be sold or transferred as part of such a transaction, as permitted by law and/or contract. Should such a sale or transfer occur, we will use reasonable efforts to try to require that the transferee use personal information provided through this Site in a manner that is consistent with this Privacy Policy.
  • Aggregate or Anonymous Non-Personal Information: We may also share aggregate, or de-identified non-personal information with third parties for their marketing or analytics uses.

  • Advertising Partners: Through our Services, we may allow third-party advertising partners to set Technologies and other tracking tools to collect information regarding your activities and your device (e.g., your IP address, mobile identifiers, page(s) visited, location, time of day). We may also combine and share such information and other information (such as demographic information and past purchase history) with third-party advertising partners. These advertising partners may use this information (and similar information collected from other websites) for purposes of delivering targeted advertisements to you when you visit third-party websites within their networks. This practice is commonly referred to as “interest-based advertising” or “online behavioral advertising. We may allow access to other data collected by the Services to share information that may be useful, relevant, valuable or otherwise of interest to you. If you prefer not to share your personal information with third-party advertising partners, you may follow the instructions below.

  • Other: We also may share your information as disclosed to you at the time of collection or disclosure.

    Please see the “Addendum: California Privacy Rights” for more information.

4. YOUR CHOICES AND OPT-OUTS

A. Cookies, Tracking Options and California Do Not Track Disclosures

Certain parts of our Site require cookies. You may adjust your device or Internet browser settings to limit certain tracking or to decline cookies, but by doing so, you may not be able to use certain features of the Site or take full advantage of all of our offerings. Please refer to your device’s settings or your Internet browser’s “Help” section for more information on how to delete and/or disable your device or browser from receiving cookies or controlling your tracking preferences.

Our system may not recognize Do Not Track requests or headers from some or all browsers. We may use cookies or other technologies to deliver advertising for our products when you visit other websites.

B. Interest-Based Advertising Choices

To understand your choices for receiving more relevant advertising provided on other websites and online services, please review the information below:

  • To learn more about such interest-based advertising, and to opt out of such collection and use for interest-based advertising by the Digital Advertising Alliance (DAA) participating companies, please visit http://optout.aboutads.info.
  • To opt out from the use of information about your online activities for interest-based advertising by Network Advertising Initiative (NAI) member companies, please visit http://optout.networkadvertising.org.
  • If you wish to prevent your data from being used by Google Analytics, Google has developed the Google Analytics opt-out browser add-on available https://tools.google.com/dlpage/gaoptout/.
  • On your mobile device, you may also adjust your privacy and advertising settings to control whether you want to receive more relevant advertising.

Please note you must separately opt out in each browser and on each device. Even if you opt out, you still may receive advertising from us that is not customized based on your Service or usage information, or advertising from other third parties if they are not a DAA or NAI participating company.

C. Unsubscribing from our Marketing Communications

We provide our Site visitors with the opportunity to update their information or opt-out of having their information used for purposes not directly related to placement, processing, fulfillment, or delivery of a product order or servicing of your product or request. To opt-out of marketing communications, you may:

  • Send us an e-mail at privacy@dompe.com;
  • Contact us by mail at the address below in the “Contact Us” section, or
  • Unsubscribe from our email communications at any time by selecting unsubscribe in the email or clicking here.

If you receive marketing communications from one or more Dompé affiliates, you must opt-out individually from each of the affiliates from which you are receiving brand-specific marketing communications (e.g., unsubscribe-oxervate@dompe.com).

Your instructions to limit the use of your information for these purposes will be processed as soon as reasonably practicable.

D. Updating Your Information

If you wish to update any of your personal information, you may contact us at the address or e-mail in the “How to Contact Us” section below.

E. Your GDPR Rights

The GDPR gives you certain privacy rights which include: the right to request access to your information at any time, the right to request correction of your information; the right to object to processing of your information, the right to restrict processing of your information and to request erasure; the right to request transferring some of your information to other organizations. To exercise your privacy rights please contact us as set forth in “How to Contact Us” Below.

5. YOUR CALIFORNIA PRIVACY RIGHTS

(FOR ADDITIONAL INFORMATION SEE CALIFORNIA ADDENDUM BELOW)

Dompé shares personal information between Dompé affiliates and marketing agents for marketing purposes. We do not share your personal information with unaffiliated third parties for their own independent marketing purposes without your consent. California residents may request the categories of personal information Dompé shared with third-parties for the third parties' direct marketing purposes during the previous calendar year, if any. To make your request, send an email to privacy@dompe.com. Written requests from California residents may be sent to:

Dompé U.S.
Attn: Privacy Officer
One Marina Park Dr., Suite 1410
Boston, MA 02210

You must put the statement “Your California Privacy Rights” in the subject field of your email. We are not responsible for notices that are not labeled or sent properly, or do not have complete information.

6. CHILDREN’S PRIVACY

Protecting children’s privacy is important to us. We do not direct the Site to, nor do we knowingly collect any personal information from, children under the age of eighteen (or other age as required by local law). If you learn that your child has provided us with personal information without your consent, you may contact the Dompé Privacy Officer as set forth above. If we learn that we have collected any personal information in violation of applicable law, we will promptly take steps to delete such information unless we have a legal obligation to maintain it, and will terminate the child’s account.

7. DATA RETENTION AND SECURITY

We store the personal information we receive as described in this Privacy Policy for as long as you use our Services or as necessary to fulfill the purpose(s) for which it was collected, provide our Services, resolve disputes, establish legal defenses, conduct audits, pursue legitimate business purposes, enforce our agreements, and comply with applicable laws. We have taken certain physical, administrative, and technical steps to safeguard the information we collect from and about our customers and Site visitors. While we make every effort to help ensure the integrity and security of our network and systems, we cannot guarantee our security measures.

By providing personal information, you agree that we may communicate with you electronically regarding security, privacy, and administrative issues relating to your use of the Services. If we learn of a security system’s breach, we may attempt to notify users electronically by posting a notice on the Services, by mail or by sending an e-mail to affected users.

8. INTERNATIONAL TRANSFER

Your personal information is stored on servers in the United States; however, some of our brands, subsidiaries, parent company, and Service Providers may store information on servers hosted in other countries. As such, your personal information may be subject to the laws of other countries, where the data protection and other laws may differ from those of the United States. We have taken appropriate safeguards to require that users’ personal information will remain protected and requires all third-party service providers and partners to have appropriate safeguards as well. Your personal information may be disclosed in response to inquiries or requests from government authorities or to respond to judicial process in the countries in which we operate.

9. REVISIONS TO THIS PRIVACY POLICY

We reserve the right, at our sole discretion, to change, modify, add, remove, or otherwise revise portions of this Policy at any time. When we do, we will post the change(s) on the Site. Your continued use of the Site following the posting of changes to these terms means you accept these changes. If we change the Privacy Policy in a material way, we will provide appropriate notice to you as required under applicable law.

10. HOW TO CONTACT US

If you have any questions or concerns about this Policy or the practices described herein, or if you would like to exercise your rights under this policy, the Data Protection Officer may be contacted by email at DPO@dompe.com.

You may also contact us at privacy@dompe.com or by mail to:

Dompé
Via San Martino 12/12a, Milan
20122 Milano, Italy,
Boston, MA 02210

Dompé U.S.

Attn: Privacy Officer

One Marina Park Dr., Suite 1410

Boston, MA 02210

ADDENDUM: CALIFORNIA PRIVACY RIGHTS

This section of the notice applies solely to visitors, users, health care providers, patients, and others who reside in the State of California (referred to herein as a “consumer” or “consumers”). We adopt this notice to comply with the California Consumer Privacy Act of 2018 (“CCPA”) and other California privacy laws. Any terms defined in the CCPA have the same meaning when used in this notice. The term “personal data” means “personal information” for purposes of the CCPA.

Personal Data We Collect Under the CCPA

We collect personal data that identifies, relates to, describes, is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, with a particular consumer or household. We have collected the following categories of personal data from consumers within the last twelve (12) months:

  • Identifiers. A real name, alias, postal address, unique personal identifier, online identifier, IP address, email address, account name, or other similar identifiers.
    • Protected Classification Characteristics Under California or Federal Law
      Age (40 years or older), race, color, ancestry, national origin, citizenship, marital status, medical condition, physical or mental disability, sex, genetic information (including familial genetic information).
  • Commercial Information. Records of personal property, products or services purchased, obtained, or considered, or other purchasing or consuming histories or tendencies.
  • Biometric Info. An individual’s physiological, biological, or behavioral characteristics, that can be used, singly or in combination with each other or with other identifying data, to establish individual identity. Biometric information includes, but is not limited to, gait patterns or rhythms, and sleep, health, or exercise data that contain identifying information.
  • Internet or Other Electronic Network Activity Information. Browsing history, search history, and information regarding a consumer's interaction with a website, application, or advertisement.
  • Geolocation. Physical location or movements.
  • Inferences Drawn from Other Personal Data. Inferences drawn from the information identified above to create a profile reflecting a person's preferences, characteristics, psychological trends, predispositions, behavior, attitudes, intelligence, abilities, and aptitudes.

Personal data does not include:

  • Publicly available information from government records;
  • De-identified or aggregated consumer information; or
  • Information excluded from the CCPA.

We obtain the categories of personal data listed above from the following categories of sources:

  • You and your devices;
  • Your business partners and employees
  • Our business partners or their agents;
  • Our website, applications, devices and services;
  • Consumer data resellers;
  • Public records;
  • From third-parties that interact with us in connection with our products and services.

Use of Personal Data

We may use or disclose the personal data we collect for one or more of the following business purposes:

  • Auditing related to a current interaction with you and concurrent transactions, including, but not limited to, counting ad impressions to unique visitors, verifying positioning and quality of ad impressions, and auditing compliance with this specification and other standards;
  • Detecting security incidents, protecting against malicious, deceptive, fraudulent, or illegal activity, and prosecuting those responsible for that activity;
  • Debugging to identify and repair errors that impair existing intended functionality;
  • Short-term, transient use, including, but not limited to, the contextual customization of ads shown as part of the same interaction;
  • Performing services, including maintaining or servicing accounts, providing customer products or services, processing or fulfilling orders and transactions, verifying customer information, processing payments, providing financing, providing advertising or marketing services, providing analytic services, or providing similar services on behalf of the business or service provider;
  • Undertaking internal research for technological development and demonstration;
  • Undertaking activities to verify or maintain the quality or safety of a service or device that is owned, manufactured, manufactured for, or controlled by us, and to improve, upgrade, or enhance the service or device that is owned, manufactured, manufactured for, or controlled by us;
  • For business related activities such as contact options, planning, and marketing preferences;
  • As described to you when your personal data is collected, as directed by you or as otherwise permitted under the CCPA or applicable law;
  • When you have provided your consent/authorization, to support benefit resolution and prescription fulfillment; and/or
  • To evaluate or conduct a merger, divestiture, restructuring, reorganization, dissolution, or other sale or transfer of some or all of our assets, whether as a going concern or as part of bankruptcy, liquidation, or similar proceeding, in which personal data held by us is among the assets transferred.

Sharing Personal Data

We have not sold consumers’ personal data in the preceding 12 months. We may disclose your personal data to a third party for a business purpose. When we disclose personal data for a business purpose, we enter a contract that describes the purpose and requires the recipient to both keep that personal data confidential and not use it for any purpose except performing the contract. In the past 12 months, Dompé may have disclosed the following categories of information about consumers for a business purpose:

  • Name and Other Identifiers such as real name, alias, postal address, unique personal identifier, online identifier, internet protocol address, email address, account name, social security number, driver’s license number, passport number, or other similar identifiers.
    • Protected Classification Characteristics Under California or Federal Law
      • Age (40 years or older), race, color, ancestry, national origin, citizenship, marital status, medical condition, physical or mental disability, sex genetic information (including familial genetic information).
  • Commercial Information. Records of personal property, products or services purchased, obtained, or considered, or other purchasing or consuming histories or tendencies.
  • Network Activity Information including, but not limited to, browsing history, search history, and information regarding a consumer’s interaction with an internet website, application, or advertisement.
  • Geolocation Data. Business or personal location for delivery of products or services
  • Professional, Education, and Employment-Related Information.
  • Inferences Drawn from any of the information above to create a profile about a consumer reflecting the consumer’s preferences, characteristics, psychological trends, predispositions, behavior, attitudes, intelligence, abilities, and aptitudes.

We disclose your personal data for a business purpose to the following categories of third parties:

  • Our affiliates and business partners;
  • Advertising networks;
  • Internet service providers;
  • Data analytics providers;
  • Government entities;
  • Social networks;
  • Service providers such as entities who provide: IT and related services; services performed on their operating systems and platforms; information you have requested; customer service activities; and our products and services; and/or
  • Third parties to whom you or your agents authorize us to disclose your personal data in connection with products or services we provide to you.

Your Rights and Choices

In accordance with applicable law, you may have the right to:

Access to/portability of personal data about you consistent with legal requirements. In addition, you may have the right in some cases to receive or have your electronic personal data transferred to another party.

Request correction of your personal data where it is inaccurate or incomplete. In some cases, we may provide self-service tools that enable you to update your personal data or we may refer you to the controller of your personal data who is able to make the correction.

Request Deletion of your personal data, subject to certain exceptions prescribed by law.

If you would like to exercise any of these rights, please log into your account, writing to us or emailing us as set forth in Section 10, “How to Contact Us” above. We will process such requests in accordance with applicable laws. To protect your privacy, we will take steps to verify your identity before fulfilling your request.

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    References:

    1. OXERVATE™ (cenegermin-bkbj) ophthalmic solution 0.002% (20 mcg/mL) [US package insert]. Boston, MA: Dompé U.S. Inc.; 2018.
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    3. Stedman's Medical Dictionary. Baltimore, MD: Lippincott Williams & Wilkins; 2006.
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    9. Lambiase A, Sacchetti M. Neurotrophic factors and corneal nerve regeneration. Neural Regen Res. 2017;12(8):1220.
    10. Facts About the Cornea and Corneal Disease | National Eye Institute. https://nei.nih.gov/health/cornealdisease. Published 2016. Accessed June 5, 2019.
    11. Dua H, Said D, Messmer E, et al. Neurotrophic keratopathy. Prog Retin Eye Res. 2018;66:107-131.

    Important Safety Information

    OXERVATE™ (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis.

    Important Safety Information

    MORE LESS

    Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration.

    OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment. The patient should be advised to contact their doctor if a more serious eye reaction occurs.

    The most common adverse reaction in clinical trials that occurred more frequently with OXERVATE was eye pain (16% of patients). Adverse reactions included corneal deposits, foreign body sensations in the eye, ocular hyperemia (enlarged blood vessels in the white of the eyes), swelling (inflammation) of the eye, and increase of tears (1-10% of patients).

    WHAT IS OXERVATE™?

    OXERVATE™ (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis.

    DOSAGE FORMS AND STRENGTHS

    Ophthalmic solution for topical use in the eye: cenegermin-bkbj 0.002% (20 mcg/mL) is a clear, colorless solution in a multiple-dose vial.

    CONTRAINDICATIONS

    None.

    WARNINGS AND PRECAUTIONS

    Use With Contact Lenses

    Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration.

    Eye Discomfort

    OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment. The patient should be advised to contact their doctor if a more serious eye reaction occurs.

    ADVERSE REACTIONS

    Clinical Studies Experience

    Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be compared directly to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

    In 2 clinical trials of patients with neurotrophic keratitis, a total of 101 patients received cenegermin-bkbj eye drops at 20 mcg/mL at a frequency of 6 times daily in the affected eye(s) for a duration of 8 weeks. The mean age of the population was 61 to 65 years of age (18 to 95).

    The most common adverse reaction in clinical trials that occurred more frequently with OXERVATE was eye pain (16% of patients). Other adverse reactions included corneal deposits, foreign body sensation in the eye, ocular hyperemia (enlarged blood vessels in the white of the eye), swelling (inflammation) of the eye, and increase in tears (1%-10% of patients).

    USE IN SPECIFIC POPULATIONS

    Pregnancy

    Risk Summary

    There are no data from the use of OXERVATE in pregnant women to inform any drug-associated risks.

    Administration of cenegermin-bkbj to pregnant rats or rabbits during the period of organogenesis did not produce adverse fetal effects at clinically relevant doses. In a pre- and postnatal development study, administration of cenegermin-bkbj to pregnant rats throughout gestation and lactation did not produce adverse effects in offspring at clinically relevant doses.

    Data

    Animal Data

    In embryofetal development studies, daily subcutaneous administration of cenegermin-bkbj to pregnant rats and rabbits throughout the period of organogenesis produced a slight increase in postimplantation loss at doses greater than or equal to 42 mcg/kg/day (267 times the maximum recommended human ophthalmic dose [MRHOD]). A no-observed-adverse-effect level (NOAEL) was not established for postimplantation loss in either species. In rats, hydrocephaly and ureter anomalies were observed once each in fetuses at 267 mcg/kg/day (1709 times the MRHOD). In rabbits, cardiovascular malformations, including ventricular and atrial septal defects, enlarged heart, and aortic arch dilation, were observed once each in fetuses at 83 mcg/kg/day (534 times the MRHOD). No fetal malformations were observed in rats and rabbits at doses of 133 mcg/kg/day and 42 mcg/kg/day, respectively.

    In a pre- and postnatal development study, daily subcutaneous administration of cenegermin-bkbj to pregnant rats during the period of organogenesis and lactation did not affect parturition and was not associated with adverse toxicity in offspring at doses up to 267 mcg/kg/day.

    In parental rats and rabbits, an immunogenic response to cenegermin-bkbj was observed. Given that cenegermin-bkbj is a heterologous protein in animals, this response may not be relevant to humans.

    Lactation

    Risk Summary

    There are no data on the presence of OXERVATE in human milk, the effects on breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OXERVATE and with any potential adverse effects on the breastfed infant.

    Pediatric Use

    The safety and effectiveness of OXERVATE have been established in the pediatric population. Use of OXERVATE in pediatric patients 2 years of age and older is supported by evidence from adequate and well-controlled trials of OXERVATE in adults with additional safety data in children.

    Geriatric Use

    Of the total number of subjects in clinical studies of OXERVATE, 43.5% were 65 years old and older. No overall differences in safety or effectiveness were observed between elderly and younger adult patients.

    The risk information provided here is not comprehensive. To learn more, talk about OXERVATE with your health care provider or pharmacist.

    Important Safety Information

    MORE LESS

    Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration.

    OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment. The patient should be advised to contact their doctor if a more serious eye reaction occurs.

    The most common adverse reaction in clinical trials that occurred more frequently with OXERVATE was eye pain (16% of patients). Adverse reactions included corneal deposits, foreign body sensations in the eye, ocular hyperemia (enlarged blood vessels in the white of the eyes), swelling (inflammation) of the eye, and increase of tears (1-10% of patients).

    WHAT IS OXERVATE™?

    OXERVATE™ (cenegermin-bkbj) ophthalmic solution 0.002% is indicated for the treatment of neurotrophic keratitis.

    DOSAGE FORMS AND STRENGTHS

    Ophthalmic solution for topical use in the eye: cenegermin-bkbj 0.002% (20 mcg/mL) is a clear, colorless solution in a multiple-dose vial.

    CONTRAINDICATIONS

    None.

    WARNINGS AND PRECAUTIONS

    Use With Contact Lenses

    Contact lenses should be removed before applying OXERVATE because the presence of a contact lens (either therapeutic or corrective) could theoretically limit the distribution of cenegermin-bkbj onto the area of the corneal lesion. Lenses may be reinserted 15 minutes after administration.

    Eye Discomfort

    OXERVATE may cause mild to moderate eye discomfort such as eye pain during treatment. The patient should be advised to contact their doctor if a more serious eye reaction occurs.

    ADVERSE REACTIONS

    Clinical Studies Experience

    Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be compared directly to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

    In 2 clinical trials of patients with neurotrophic keratitis, a total of 101 patients received cenegermin-bkbj eye drops at 20 mcg/mL at a frequency of 6 times daily in the affected eye(s) for a duration of 8 weeks. The mean age of the population was 61 to 65 years of age (18 to 95).

    The most common adverse reaction in clinical trials that occurred more frequently with OXERVATE was eye pain (16% of patients). Other adverse reactions included corneal deposits, foreign body sensation in the eye, ocular hyperemia (enlarged blood vessels in the white of the eye), swelling (inflammation) of the eye, and increase in tears (1%-10% of patients).

    USE IN SPECIFIC POPULATIONS

    Pregnancy

    Risk Summary

    There are no data from the use of OXERVATE in pregnant women to inform any drug-associated risks.

    Administration of cenegermin-bkbj to pregnant rats or rabbits during the period of organogenesis did not produce adverse fetal effects at clinically relevant doses. In a pre- and postnatal development study, administration of cenegermin-bkbj to pregnant rats throughout gestation and lactation did not produce adverse effects in offspring at clinically relevant doses.

    Data

    Animal Data

    In embryofetal development studies, daily subcutaneous administration of cenegermin-bkbj to pregnant rats and rabbits throughout the period of organogenesis produced a slight increase in postimplantation loss at doses greater than or equal to 42 mcg/kg/day (267 times the maximum recommended human ophthalmic dose [MRHOD]). A no-observed-adverse-effect level (NOAEL) was not established for postimplantation loss in either species. In rats, hydrocephaly and ureter anomalies were observed once each in fetuses at 267 mcg/kg/day (1709 times the MRHOD). In rabbits, cardiovascular malformations, including ventricular and atrial septal defects, enlarged heart, and aortic arch dilation, were observed once each in fetuses at 83 mcg/kg/day (534 times the MRHOD). No fetal malformations were observed in rats and rabbits at doses of 133 mcg/kg/day and 42 mcg/kg/day, respectively.

    In a pre- and postnatal development study, daily subcutaneous administration of cenegermin-bkbj to pregnant rats during the period of organogenesis and lactation did not affect parturition and was not associated with adverse toxicity in offspring at doses up to 267 mcg/kg/day.

    In parental rats and rabbits, an immunogenic response to cenegermin-bkbj was observed. Given that cenegermin-bkbj is a heterologous protein in animals, this response may not be relevant to humans.

    Lactation

    Risk Summary

    There are no data on the presence of OXERVATE in human milk, the effects on breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OXERVATE and with any potential adverse effects on the breastfed infant.

    Pediatric Use

    The safety and effectiveness of OXERVATE have been established in the pediatric population. Use of OXERVATE in pediatric patients 2 years of age and older is supported by evidence from adequate and well-controlled trials of OXERVATE in adults with additional safety data in children.

    Geriatric Use

    Of the total number of subjects in clinical studies of OXERVATE, 43.5% were 65 years old and older. No overall differences in safety or effectiveness were observed between elderly and younger adult patients.

    The risk information provided here is not comprehensive. To learn more, talk about OXERVATE with your health care provider or pharmacist.