PRIVACY POLICY

Last updated: September 25, 2020

Pharmacosmos Therapeutics Inc. (“Pharmacosmos”) is committed to protecting your privacy. We have prepared this Privacy Policy to describe to you our practices regarding the Personal Data (as defined below) we collect from users of our websites with links to this Privacy Policy (the “Site”).

Questions: Contacting Pharmacosmos. If you have any questions or comments about our Privacy Policy, please contact us at the following:

Pharmacosmos Therapeutics Inc.
776 Mountain Boulevard
Suite 101B
Watchung, NJ 07069 USA
Attn: General Counsel
Email: legal@pharmacosmos.us

User Consent. PLEASE READ THIS PRIVACY POLICY CAREFULLY BEFORE USING OUR SITE. By visiting our Site, you agree to the terms of this Privacy Policy and you expressly consent to the collection, use and disclosure of your Personal Data in accordance with this Privacy Policy. If you do not agree with the Privacy Policy, you are not authorized to access or use or provide information through our Site.

A Note About Children. This Site is directed toward adults and we do not knowingly gather Personal Data from visitors who are under the age of 13. If we discover that a child under 18 has submitted Personal Data to Pharmacosmos, we will attempt to delete the information as soon as possible. If you believe that we might have any Personal Data from a child under 13, please contact us at legal@pharmacosmos.us.

A Note to Users Outside of the United States. Your Personal Data may be processed in the country in which it was collected and in other countries, including the United States, where laws regarding the processing of Personal Data may be less protective than the laws in your country. By providing your data, you consent to such processing and transfer.

Types of Data We Collect. “Personal Data” means data that, by itself, allows someone to identify or contact you as an individual, including, for example, your name, address, telephone number, e-mail address, as well as any other non-public information about you that is associated with or linked to any of the foregoing data. “Anonymous Data” means data that does not, by itself, permit the identification of individual persons and that is not associated with or linked to Personal Data. We collect Personal Data and Anonymous Data, as described below.

(a) Information You Provide to Us.

•	If you provide us feedback or contact us via e-mail, we will collect your name, title, e-mail address, and any other content included in your e-mail to us, in order to send you a reply. If you choose to provide us with Personal Data, you consent to the transfer and storage of that information on our servers.
•	We will also collect Personal Data at other points in our Site that state that Personal Data is being collected. For example, you may share Personal Data to register on one of our websites, to submit or to request information from us, or to participate in other voluntary programs that we may offer through our websites from time to time.

(b) Information Collected via Technology.

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Information Collected by Our Servers. To make our Site more useful to you, our servers (which may be hosted by a third-party service provider) may collect information from your computer or device, including but not limited to:

o	The date and time of your visit and the web pages, content, and advertisements you view and links you click on while navigating within our Site;
o	Information about the type of content accessed via our Site;
o	The site you visited before and after visiting our Site;
o	Your Internet Protocol (IP) address (a numerical address assigned to your computer by your Internet service provider so that other computers connected to the Internet can communicate with your browser online) that can sometimes be used to derive your general geographic area;
o	Search terms you enter on a referral site;
o	Information about your device such as your device type, browser type, language and other settings, memory capacity, plug-ins, Internet domain, advertising identifiers, TCP configuration parameters, operating system, time zone and the names, versions and package IDs of software installed on your device; and
o	Information collected through cookies and other tracking technologies (see additional descriptions of these terms below).

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Cookies. Like many online services, we use cookies to collect information and aggregate data. “Cookies” are small pieces of information that a website sends to your computer’s hard drive while you are viewing the website. We may use both session Cookies (which expire once you close your web browser) and persistent Cookies (which stay on your computer until you delete them) to provide you with a more personal and interactive experience on our Site. We may use cookies to let us know that you are a prior user of the Site and to retrieve certain information previously provided by you. We also may use cookies to keep track of information about your current session which will be discarded as soon as you log out or close your web browser. This information also allows us to statistically monitor how many people are using our Site and for what purpose. However, if you do not wish to receive cookies, or want to be notified of when they are placed, your internet browser may permit you to do so. In many internet browsers, you can change the browser settings to warn you before accepting cookies or to block cookies; the “Help” portion of the tool bar on most browsers will instruct you as to how you may prevent your browser from accepting new cookies or notify you when you receive new cookies. If you block cookies, you may still use our Site, but you may not be able to use certain web site features or functions, or the Website may not operate in an optimal mode.

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Pixel Tags. In addition, we may use “Pixel Tags” (also referred to as clear Gifs, Web beacons, or Web bugs). Pixel Tags are tiny graphic images with a unique identifier, similar in function to Cookies, that are used to track online movements of Web users. In contrast to Cookies, which are stored on a user’s computer hard drive, Pixel Tags are embedded invisibly in Web pages.

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Do Not Track. We do not currently respond to “do not track” signals from web browsers.

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Analytics Services. We may use third-party analytics services to help analyze how users use our Site (“Analytics Services”). The information generated by the Cookies or other technologies about your use of our Site (the “Analytics Information”) is transmitted to the Analytics Services. The Analytics Services use Analytics Information to compile reports on user activity and your use of the Site and to provide other services relating to Site activity and Internet usage. The Analytics Services may also transfer the Analytics Information to third parties where required to do so by law, or where such third parties process Analytics Information on their behalf. Each Analytics Service’s ability to use and share Analytics Information is restricted by such Analytics Service’s terms of use and privacy policy. By using our Site, you consent to the processing of data about you by Analytics Services in the manner and for the purposes set out above. For a full list of Analytics Services, please contact us at info@pharmacosmos.us.

Use of Your Personal Data

(a) General Use. In general, Personal Data you submit to us is used either to respond to requests that you make, aid us in serving you better, and improve our Site. We and our authorized service providers may use your Personal Data in various ways, including to:

•	provide improved administration of our Site, diagnose problems with the servers and equipment used in connection with the Site and gather broad demographic data;
•	measure and analyze audience traffic and improve the quality of your experience when you interact with our Site and our services;
•	contact you to follow up on a request you made;
•	prevent potentially prohibited or illegal activities, comply with applicable law, and enforce the terms of any agreements we may have with you; and
•	for any other purposes disclosed to you at the time we collect your information or pursuant to your consent.

(b) Creation of Anonymous Data. We may create Anonymous Data records from Personal Data by excluding information (such as your name) that makes the data personally identifiable to you. We reserve the right to use Anonymous Data for any purpose and disclose Anonymous Data to third parties in our sole discretion.

(c) Third-Party Data. From time to time, we may use or augment your Personal Data with information obtained from a third party source. For example, we may use Personal Data in conjunction with information obtained from a state licensing board to verify the licensure of healthcare professionals.

(d) Submission of Data Belonging to Third Parties. If you submit to us personal data relating to other people, you represent that you have the authority to do so and to permit us to use that personal data in accordance with this Privacy Policy.

Disclosure of Your Personal Data. We disclose your Personal Data as described below and as described elsewhere in this Privacy Policy.

(a) Third-Party Service Providers. We may share your Personal Data with third-party service providers that conduct quality assurance testing, provide technical or customer support, and/or provide other services to Pharmacosmos, including to assist us in analyzing how our Site is used. We have contracts in place with such organizations that prevent them from using Personal Data in any other way than how we instruct them. These contracts also require them to maintain good standards of security to ensure the confidentiality of your Personal Data.

(b) Affiliates. We may share some or all of your Personal Data with our parent company, subsidiaries, joint ventures, or other companies under common control with Pharmacosmos (“Affiliates”), in which case we will require our Affiliates to honor this Privacy Policy.

(c) Corporate Restructuring. We may share some or all of your Personal Data in connection with or during negotiation of any merger, financing, acquisition or dissolution transaction or proceeding involving the sale, transfer, or divestiture of all or a portion of our business or assets. In the event of an insolvency, bankruptcy, or receivership, Personal Data may also be transferred as a business asset. If another company acquires our company, business, or assets, that company will possess the Personal Data collected by us and will assume the rights and obligations regarding your Personal Data as described in this Privacy Policy.

(d) Other Disclosures. Regardless of any choices you make regarding your Personal Data (as described below), Pharmacosmos may disclose Personal Data if it believes in good faith that such disclosure is appropriate (a) in connection with any legal investigation or proceeding; (b) to comply with relevant laws or to respond to subpoenas or warrants served on Pharmacosmos; (c) to protect or defend the rights or property of Pharmacosmos, its affiliates or its users; and/or (d) to investigate or assist in preventing any violation or potential violation of the law, this Privacy Policy, our applicable Terms of Use Agreement, or any other contractual arrangement.

Third-Party Websites. Our Site may contain links to third-party websites. When you click on a link to any other website, you will leave our Site and go to another site, and another entity may collect Personal Data or Anonymous Data from you. We have no control over, do not review, and cannot be responsible for, these outside websites or their content. Please be aware that the terms of this Privacy Policy do not apply to these outside websites, or to any collection of your Personal Data after you click on links to such outside websites. We encourage you to read the privacy policies of every website you visit. The links to third-party websites are for your convenience and do not signify our endorsement of such third parties or their products, content or services.

Your Choices Regarding Information. You have several choices regarding the use of information on our Service:

(a) Cookies. If you decide at any time that you no longer wish to accept Cookies for any of the purposes described above, then you can instruct your browser, by changing its settings, to stop accepting Cookies or to prompt you before accepting a Cookie from the websites you visit. Consult your browser’s technical information. If you do not accept Cookies, however, you may not be able to use all portions of the Site or all functionality of the Site. If you have any questions about how to disable or modify Cookies, please let us know at the contact information provided above.

(b) Accessing, Changing or Deleting Your Personal Data. You may request deletion of your Personal Data by us, and we will use commercially reasonable efforts to honor your request, but please note that we may be required to keep such information and not delete it (or to keep this information for a certain time, in which case we will comply with your deletion request only after we have fulfilled such requirements). When we delete any information, it will be deleted from the active database, but may remain in our archives. We may also retain your information for fraud prevention or similar purposes.

Security and Risk of Disclosure. We use a variety of security measures and technologies to help protect your Personal Data from unauthorized access, use, disclosure, alteration, or destruction in line with applicable data protection and privacy laws. However, no Internet transmission is ever 100% secure or error-free. More specifically, information transmitted to or from the Site may not be via a secure connection. As a result, you should take particular care in deciding what information you send via our Site.

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Retention. We will retain your Personal Data as long as necessary to provide you the services offered there through and the other permitted uses specified herein, and for a reasonable transition time thereafter. We may store Anonymous Data (i.e., information that is not Personal Data) indefinitely.

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Changes to This Privacy Policy. This Privacy Policy may be updated from time to time for any reason. We will notify you of any changes to our Privacy Policy by posting the new Privacy Policy at www.monoferric.com/privacy and we will change the “Last Updated” date above. You should consult this Privacy Policy regularly for any changes.

INDICATIONS

Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

who have intolerance to oral iron or have had unsatisfactory response to oral iron
who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Monoferric. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Monoferric is contraindicated in patients with prior serious hypersensitivity reactions to Monoferric or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Monoferric treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.

Iron Overload

Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Monoferric to patients with iron overload.

ADVERSE REACTIONS

Adverse reactions were reported in 8.6% (172/2008) of patients treated with Monoferric. Adverse reactions related to treatment and reported by ≥1% of the treated patients were nausea (1.2%) and rash (1%). Adjudicated serious or severe hypersensitivity reactions were reported in 6/2008 (0.3%) patients in the Monoferric group. Hypophosphatemia (serum phosphate <2.0 mg/dL) was reported in 3.5% of Monoferric-treated patients in Trials 1 & 2.

To report adverse events, please contact Pharmacosmos at 1-888-828-0655. You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Please see Full Prescribing Information.