Privacy Policy

Effective September 1, 2020

METACEL PRIVACY POLICY

PLEASE READ THIS PRIVACY POLICY CAREFULLY. IT CONTAINS IMPORTANT INFORMATION REGARDING OUR COLLECTION AND USE OF YOUR PERSONAL INFORMATION, AND YOUR CONSENT TO OUR DOING SO IN REGARD TO THE SERVICES WE MAY PROVIDE.

This Privacy Policy (“Policy”) explains how Metacel Pharmaceuticals LLC and its subsidiaries, affiliates and successors (collectively, “Metacel”) collect, handle and use your Personal Information, including in regard to Metacel’s various products, services, websites and applications (collectively, “Services”). For the purposes of this Policy, “Personal Information” means any information related to an individual, whether given online or offline, including information that Metacel collects directly, is collected on Metacel’s behalf, or is otherwise directed to Metacel.

Please read this Policy carefully before using or engaging Metacel’s Services or submitting any Personal Information. By accessing, using and otherwise benefiting from Metacel’s Services, you consent to the collection, use and disclosure of your Personal Information in accordance with this Policy. While this Policy may address or reference certain Services, nothing stated in this Policy constitutes a promise, covenant or other undertaking by Metacel that it will provide some or any Services, whether now or in the future. Also, while this Policy may outline certain categories of Personal Information that Metacel might collect, nothing in this Policy is intended as a statement as to which Personal Information Metacel does collect.

Information We Collect

Metacel collects Personal Information that you choose to give, including through various registrations, applications and surveys, and in regard to inquiries you submit and purchases you make. You may provide Personal Information directly to Metacel, or to third party services, platforms, and others from whom Metacel may then acquire it. For example, you may give your name, contact, health, insurance, financial, and other information in connection with a promotion, or a copay savings or patient assistance or patient support program. Metacel may also gather Personal Information through your interactions with Metacel and its affiliated websites, like www.metacelrx.com and www.ozobax.com, where Metacel may learn your IP address, your navigation preferences, and browsing tools and programs.

Metacel may supplement an individual’s Personal Information with information obtained from other sources. For example, Metacel may use third party information to verify a healthcare professional’s licensure. Or Metacel might cross reference your Personal Information with various demographic, financial and other information to build, design, evaluate, launch, and improve Metacel’s Services. If you submit Personal Information relating to other people, you represent that you have the authority to do so and to permit us to use the information in accordance with this Policy.

How We Collect Information

Metacel collects Personal Information in various way and through multiple channels, including from the following:

  • Directly from individuals;
  • Our websites and, to the extent applicable, mobile applications;
  • Metacel’s business partners and vendors, third party service providers, and data brokers;
  • Public databases, social media platforms, and third-party sites and services;
  • Contract research organizations and clinical trial investigators;
  • Individuals enrolled in clinical trials or otherwise participating in research;
  • Online or paper applications for patient support, compassionate use, and expanded access programs;
  • Healthcare professionals;
  • Government agencies, regulatory authorities, or public records;
  • Patient groups and associations; and
  • Industry groups and associations.

Personal Information That We May Collect – General Public

Metacel collects a broad range of Personal Information related to individuals, including although not limited to the following:

  • Contact information and contact preferences, including name, email address, mailing address, telephone number, and emergency contacts;
  • Biographical and demographic information, like date of birth, age, gender, ethnicity, marital status, and sexual orientation;
  • Health and medical information, including physical and mental health conditions, diagnoses, treatments for medical conditions, genetic information, family medical history, and medications you may be taking (including dosage, timing, and frequency);
  • Information regarding parents or legal guardians;
  • Financial information;
  • Usernames and passwords an individual may use to establish an account related to Metacel’s Services;
  • Social media handle or digital or electronic signatures;
  • Your photograph;
  • Publicly available information;
  • Internet activity, like your browsing and search history and information concerning your interactions with Metacel’s Services and advertisements;
  • Inferences drawn from Personal Information in creating a profile that reflects your preferences, pertinent characteristics, motivations, wants and needs; and
  • Adverse event reports and information and complaints concerning Metacel’s Services.

Information That We May Collect – Healthcare Professionals

If you are a healthcare professional, Metacel may also collect the following information:

  • Professional credentials, educational and professional history, institutional and government affiliations, and information included on a résumé, curriculum vitae or other form;
  • Work experience, education, and languages spoken;
  • Information about the Metacel Services, including programs and products which you have interacted;
  • Your interactions with Metacel, prescribing preferences (including for Metacel products), and agreements you may have executed with Metacel; and
  • Publicly available information about your practice, like licensure, certifications, disciplinary history, litigation, regulatory work and proceedings, and the like. 

How We Use Personal Information

Metacel uses Personal Information in the regular course of business for its own internal purposes. While Metacel’s various uses for Personal Information can be broad, generally they include the following:

  • Operation and improvement of Metacel’s business and operations;
  • Delivery, design, use, launch, evaluation, and improvement of Metacel’s Services;
  • Processing, completion and fulfillment of your transaction requests with Metacel, both directly and in regard to any third-party service providers;
  • Provision of customer service and support;
  • Responding to your requests and inquiries;
  • Establishing and maintaining communications with you;
  • Designing, targeting, and improving Metacel’s marketing programs and campaigns;
  • Providing you with promotional and educational messaging and literature, newsletters, articles, alerts, announcements, invitations, and other information about Metacel’s products and brands, and also in regard to health topics and disease states;
  • Applications for Metacel Services (including their provision and completion), Metacel’s assessment of your eligibility for any of Metacel’s Services, and Metacel’s renewal of any of its Services;
  • Fulfillment of security, processing, compliance, and regulatory requirements; and
  • Compilation of statistics and data for analysis of Metacel’s sites and business.

Content Sharing, Third-Party Applications, and Your Personal Information

Metacel’s websites and other Services may allow you to share content with others. In that event, Metacel will gain access to and use of both your Personal Information and that of the person with whom you share Metacel’s content. Under this circumstance, you represent to Metacel that you have the right to share that other person’s Personal Information. Further, Metacel may provide access to third party applications, like social media widgets and associated tools and buttons. Any use of third-party sharing functionality is subject to separate and independent privacy policies and terms of service. While Metacel recommends you read these privacy policies and terms of service carefully, Metacel is not responsible for third party applications, widgets, websites or operations, or the uses to which they may put your Personal Information.  

How and With Whom We May Share Personal Information

Metacel may share and disclose your Personal Information as follows:

  • Internally and with its affiliates, including any subsidiaries or parent companies. When done, this type of sharing is for the uses and purposes stated in this Policy. If Metacel sells, transfers or assigns one of its business units or divisions, an affiliate, or an asset to an acquiring company, your Personal Information may be part of that transaction, and subject to the privacy policies of the acquiring company. You acknowledge that the acquiring company’s policies may be materially different that those stated in this Policy.
  • With third party contractors, vendors, companies and individuals who perform services relevant to Metacel and its business, including the Services. Examples of third parties with whom Metacel may share Personal Information include credit card processors, customer support specialists, marketing and data analytics firms, email and SMS/texting services, webhosting and website design vendors, logistic and order fulfillment companies, distributors and licensees of Metacel, and co-promotion and contract marketing organizations. In these instances, Metacel shall share only that portion of Personal Information necessary to the work or service in question and will undertake reasonable efforts to ensure all Personal Information is protected from subsequent use or disclosure except as may otherwise be agreed or legally permitted.
  • Whenever legally required, when necessary or appropriate in ensuring compliance with applicable regulations and law, within a judicial proceeding, under court order or civil or criminal investigatory or other government request, in response to legal process, or to protect the safety, rights, or property of our customers, the public, Metacel or others.
  • In the form of aggregated or de-identified data that is not personally identifiable to third parties for any purpose.

How We Collect Personal Information Online

Metacel and the third parties who may provide services to Metacel, including in regard to the Services, may collect Personal Information using cookies, tracking pixels, web beacons and other software, applications and technologies. Metacel may utilize this Personal Information to better understand, customize and improve user experiences with Metacel’s Services, including websites and other offerings, and to better manage and target advertising and enhanced personalization and functionality.

Accordingly, Metacel’s Services may collect information that could be Personal Information and personally identifiable, including in regard to your visits, without you actively submitting such information. As part of your use of a Metacel website or application, your internet browser automatically transmits some Personal Information, including website URL and browser type and version that your computer or device is utilizing. Passive information collection technologies can make your use of Metacel’s websites easier by allowing Metacel to provide better and more customized services based on consumer preferences, compile statistics and analyze trends. Information collected by these passive information technologies cannot generally be used to identify you without additional information. The decision to deactivate these passive sharing technologies may impede or prohibit the proper functioning of Metacel’s websites and applications.

Some of Metacel’s service providers and vendors may use their own cookies on Metacel’s websites and applications. Although Metacel may not have direct access to or control over these third-party cookies, this Policy nonetheless governs the use of these cookies. Metacel may also permit social media companies to put “widgets” on Metacel’s websites, which have the potential to track you across multiple websites. Metacel does not have control over the privacy policies or practices of these social media companies.

When Consent Required

Whenever Metacel relies on consent for the fair and lawful processing of Personal Information, Metacel will provide you the opportunity to consent before any subject Personal Information is collected. In these instances, your consent may be given through your authorized representative, including legal guardian, agent, or holder of a power of attorney. Although you may give consent, you are entitled to withdraw that consent at any time, although you acknowledge in such circumstance that you may lose essential functionality for any website or application to which that consent applied.

How We Safeguard Personal Information

Metacel employs a combination of technical, administrative and procedural measures to safeguard Personal Information from unauthorized access or use. No measure, however, can be entirely effective. Accordingly, Metacel cannot represent, warrant, covenant or guaranty that any Personal Information is and will remain secure from all theft, loss, or unauthorized access or use, or that the measures that Metacel may use always be effective. Users are responsible for maintaining the secrecy of their own passwords. If you believe that your interaction with Metacel or any Metacel Services are no longer secure, please immediately notify Metacel at info@metacelrx.com.

Retention Period

Metacel will retain your Personal Information for as long as needed or as permitted, subject to such minimum retention periods as may be legally mandated or otherwise required or as advised by counsel.

International Norms and Requirements

Metacel’s Services, including websites, are controlled and operated from the United States of America, and concern Services only intended for the benefit and consumption of persons within that territory. Accordingly, neither Metacel nor the Metacel’s Services are subject to the laws or jurisdiction of any state, country or territory other than that of the United States. Any information you provide to Metacel through the Services 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.

Children’s Privacy

Metacel does not direct its Services, including websites, to minors. Metacel does not knowingly collect personal data from minors.

State Law Access and Deletion Rights

Residents in some states, like California, may have a right know certain Personal Information that Metacel has collected on them, to know how that information is used, and to request that Metacel delete and otherwise not sell their Personal Information (collectively “State Protections”). If these State Protections exist and are in force, they are qualified and may be subject to regulatory and legal obligations and requirements that prohibit Metacel from fulfilling a request for disclosure or deletion. In some cases, Metacel may need to collect additional information to honor a request arising under State Protections, including for the purpose of verifying your identity. Once honored, you acknowledge that State Protections may prohibit your ability to use or access Metacel’s Services. If you have a request arising under State Protections, please contact info@metacelrx.com.

Your Options

You have choices in regard to how and if we communicate with you. For example, you may choose not to receive marketing email communications from Metacel by clicking the “Unsubscribe” link in our advertising emails. If you have any questions about this Policy, or if you are a California resident and would like to ask us to refrain from sharing your personal information with certain of our affiliates and other third parties for their marketing purposes, or to submit an data access or data deletion request, please contact us at info@metacelrx.com.

Modifications to Policy

Metacel may update, amend, modify or restate (collectively “modify”) this Policy from time to time and at any time without prior notice. Any modification is effective when posted to the applicable Metacel Services, including websites and applications. This Policy was last updated as of the effective date first stated above. Please periodically review this page for the latest information on Metacel’s privacy practices as any modified Policy will control the use of any Personal Information from that date forward.

Questions or Concerns

Any questions or concerns regarding Metacel’s handling or use of Personal Information or about this Policy, please email info@metacelrx.com.

Any requests to opt-out of future communications or Services from Metacel, please email info@metacelrx.com.

Alternatively, you may send a written letter or request to: Metacel Pharmaceuticals LLC, 244 E Washington Street, Suite 203, Athens, Georgia 30601; or you can call 1-844-638-2235.

Important Safety Information

OZOBAX® is contraindicated in patients with hypersensitivity to baclofen.

Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when OZOBAX is discontinued.

Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue OZOBAX before delivery.

OZOBAX can cause drowsiness and sedation. Patients should avoid the operation of machinery until they know how the drug affects them. Advise patients that the central nervous system effects of OZOBAX may be additive to those of alcohol and other CNS depressants.

OZOBAX should be used with caution in patients who have had a stroke.

OZOBAX can cause exacerbation of the following: psychotic disorders, schizophrenia, or confusional states; autonomic dysreflexia; epilepsy. Use with caution in patients with these conditions.

The most common adverse reactions (>1%) in patients treated with baclofen for spasticity are drowsiness, dizziness, weakness, nausea, confusion, hypotension, headache, insomnia, constipation, urinary frequency and fatigue.

You are encouraged to report adverse reactions to Metacel Pharmaceuticals, LLC at 1-833-469-6229 or to the FDA:  www.fda.gov/medwatch or 1-800-FDA-1088.

Please see the accompanying Full Prescribing Information.