LUPIN PRIVACY STATEMENT: SOLOSEC

Effective Date: 03/12/2024

You care about the protection of your Personal Information - and so do we. At Lupin Pharmaceutical, Inc. (USA) ("Lupin"), we work to maintain the privacy and data security of all Personal Information we collect or receive from you, including when you use our website for Solosec at www.solosec.com and https://www.solosechcp.com/ (together, the "Website").

This Privacy Statement ("Statement") applies to Personal Information Lupin collects, uses or shares, including when you visit the Website. Please read this Statement carefully. Should you have any questions about this Statement or how we handle Personal Information, please contact us at complianceandethicsoffice@lupin.com.

We may modify this Statement at any time. All changes will be effective immediately upon posting to the Website. Material changes will be conspicuously posted on the Website or otherwise communicated to you.

IF YOU ARE A CALIFORNIA OR CONNECTICUT RESIDENT, PLEASE SEE SECTION 12 BELOW FOR ADDITIONAL TERMS THAT MAY APPLY TO YOU.

IF YOU ARE A WASHINGTON OR NEVADA RESIDENT, PLEASE SEE THE OUR CONSUMER HEALTH PRIVACY STATEMENT FOR INFORMATION ABOUT OUR PRACTICES IN HANDLING CONSUMER HEALTH DATA AS DEFINED UNDER APPLICABLE LAW.

IF YOU PROVIDE PERSONAL INFORMATION WITH REGARD TO OUR PHARMACOVIGILANCE PROGRAM, PLEASE SEE OUR PHARMACOVIGILANCE PRIVACY STATEMENT WHICH DESCRIBES HOW WE COLLECT, USE AND SHARE THE PERSONAL INFORMATION YOU PROVIDE IN CONNECTION WITH THAT PROGRAM.

1. WHAT IS PERSONAL INFORMATION?

"Personal Information" (which we also refer to as "Personal Data") is information that identifies, relates to, describes, is reasonably capable of being associated with, or could reasonably be linked, directly or indirectly, with you or your household. Personal Information does not include publicly available information or aggregated information that does not include personal identifiers.

2. WHAT PERSONAL INFORMATION DO WE COLLECT?

We have collected the following categories of Personal Information from consumers within the twelve (12) months preceding the effective date of this Privacy Statement:

3. WHAT ARE THE SOURCES OF PERSONAL INFORMATION WE COLLECT?

We collect or have collected Personal Information from the following sources:

Information You Provide to Us

We collect Personal Information you provide to us in the following ways:

  • When You Communicate with Us. When you communicate with us by calling us, writing us, emailing us through our "Contact Us" webpage.
  • Drug Safety Information and Concerns. When you seek drug safety information or instructions regarding our Solosec product, seek help on how to use our products, if you have drug safety questions, report an adverse event or provide us with any comments or concerns about our products, as further described in our Pharmacovigilance Privacy Statement.

Information We Automatically Collect Using Technology

In the past, we collected information about your computer or other electronic device when you visited our Website. This information may have included your Internet Protocol (IP) address, Internet Service Provider (ISP), domain name, browser type, operating system, location, website you visit before or after you visited this Website, pages you clicked on this Website, search requests, date and time of your requests, the amount of time spent on the Website and information provided by tracking technologies, such as cookies, single-pixel tags, local share, local storage, Etags, and scripts.

In the past we used cookies in conjunction with third parties to serve advertisements to your computer or other electronic device or to collect analytics information while you are using our Website.

We have now chosen to disable advertising and analytics cookies on our Website. We still maintain essential cookies and functional cookies on our Website. Essential cookies are required for a website to function properly and are necessary to enable basic features. Functional Cookies are cookies that aid in the functionality of a website. These cookies help enhance a website’s performance and functionality, by, among other things, remembering user credentials for automatic login or a user’s preferences. If you disable functional cookies, you may not be able to use the portions of our Website or the quality of your user experience may be impacted.

Information We Collect from Third-Party Sources

We, now or in the past, have collected Personal Information from health care professionals, public sources, and third-party sources.

4. WHAT ARE THE PURPOSES FOR WHICH WE COLLECT PERSONAL INFORMATION?

We collect Personal Information for the following business or commercial purposes:

5. WHEN DO WE SHARE OR DISCLOSE PERSONAL INFORMATION?

Below, we explain (a) the purposes for which we share or disclose your Personal Information and (b) the entities with whom we disclose or share your Personal Information to provide services for us and (c) the third-party entities with which we “shared” your Personal Information to serve you with targeted advertising or related purposes. We conducted targeted advertising when we show you ads based on your Personal Information and the products we believe may interest you.

6. HOW DO WE PROTECT YOUR PERSONAL INFORMATION?

Personal Information about you will be accessible to Lupin, including its Affiliates, and to individuals and organizations that use Personal Information solely for and at our direction. Lupin may transfer your Personal Information to one of its databases outside your country of domicile.

Lupin uses reasonable security measures to protect your Personal Information. We use practices appropriate to the nature of the Personal Information to protect against the unauthorized or illegal access, destruction, use, modification, or disclosure of Personal Information.

Uses and disclosures of Personal Information by service providers acting on our behalf are governed by agreements that require Personal Information to be protected appropriately. Personal Information will only be used and disclosed by us and those working on our behalf, in a manner consistent with this Statement, other applicable privacy statements or notices, data, with accessed controlled as needed and as explicitly permitted or required by applicable laws, rules and regulations.

7. YOUR DATA PRIVACY CHOICES

We recognize that you may want to limit how your Personal Information is used and shared. We currently offer the following choices and options:

  • Updating your Personal Information: You may update your Personal Information by contacting us as described in Section 11 below.

8. ACCESS BY CHILDREN

Our Website is not directed at children and is designed for individuals who are 17 years of age or older. Where requests for information about a product are permitted by law, individuals requesting information about a product that is indicated for use by children must be 16 years of age or older. We do not knowingly collect Personal Information from children under 16 years of age, or according to local law, without obtaining verifiable parental consent prior to collection. If you are a parent or guardian that has knowledge that we have collected Personal Information from your child, please contact complianceandethicsoffice@lupin.com to request removal and we will endeavor to verify the identity of any applicable child Personal Information and make commercially reasonable attempts to delete such Personal Information.

9. SOCIAL MEDIA PLATFORMS

Lupin is active on Facebook®, Instagram®, X, previously known as Twitter, YouTube®, and LinkedIn ("Social Media") that enable online sharing and collaboration among customers. Anything you post on Social Media is public information and will not be treated confidentially. Lupin may post (or re-post) on the Website and our Social Media pages any comments or content that you post on our Social Media pages.

10. ACCESS FROM OUTSIDE THE UNITED STATES

The Website is intended for consumers within the United States. If you access our Website from outside the United States, please be aware that Personal Information may be transferred to, stored in, and processed in the United States. Certain governmental authorities may not consider the level of protection of Personal Information in the United States to be equivalent to that required by other jurisdictions.

11. CONTACT US

We seek to constantly improve how we manage the collection and use of Personal Information. If you have questions regarding this Privacy Statement or how we treat your Personal Information, please contact us using any of the methods listed below.

By contacting us, you understand that you may share, and we may collect your health information as part of your communication with us.

12. ADDITIONAL TERMS APPLICABLE TO CALIFORNIA AND CONNECTICUT RESIDENTS ONLY - YOUR PRIVACY RIGHTS

This section provides additional terms that apply to residents of California and Connecticut. In the event of a conflict between this Section and the remainder of this Privacy Statement (“Statement”), this Section shall take precedence for California and Connecticut residents. In this section only, any capitalized terms not defined in this Statement have the meanings set forth in the California Consumer Privacy Act of 2018 and its implementing regulations as amended (the “CCPA”) or the Connecticut Data Privacy Act ("CTDPA").

Your Privacy Rights:

California residents have rights regarding the privacy of their Personal Information. Connecticut residents have privacy rights over their Consumer Health Data.

1. Right to Opt Out of the Selling or Sharing of Your Personal Information

California residents have the right to opt out of the “Selling” or “Sharing” of their Personal Information as defined in the CCPA. Connecticut residents may direct us to cease processing their Personal Data for targeted advertising, selling their Personal Data, or profiling in furtherance of decisions that produce legal or similarly significant effects. As of the date of the posting of this Privacy Statement, we do not conduct any of these activities.

2. Right to Revoke Consent

If you are a Connecticut resident, you may be able to revoke consent to the processing of your Consumer Health Data you share with us, subject to certain exceptions permitted by applicable law.

3. Right to Access

California residents have the right to access any of the following which occurred in the prior 12-month period: (a) the categories of Personal Information we collected from you, (b) the categories of sources from which the Personal Information was collected, (c) the business or commercial purpose for collecting your Personal Information, (d) the categories of third parties with whom we shared your Personal Information, and (e) the specific pieces of Personal Information we collected from you. Connecticut residents have the right to confirm whether we are processing your Personal Information and to access that information.

4. Right to Request Deletion

Depending on the state in which you live, you have the right to request that we delete Personal Information we collected from you or the right to request that we delete all Personal Information we have collected about you. We will comply with such request, and direct our service providers to do the same, subject to certain exceptions permitted by applicable law.

5. Right to Correct Your Information

You have a right to request that we correct your inaccurate Personal Information. If you request that we correct inaccurate Personal Information about you, we will use commercially reasonable efforts to correct it. If necessary, we may ask that you provide documentation showing that the information we retained is inaccurate.

6. Right to Data Portability

You may request a copy of the Personal Information you previously provided to us in a portable and, to the extent technically feasible, readily usable format.

How to Exercise Your Privacy Rights. To exercise your privacy rights described in this Section, you may submit your request to us by contacting us at any of the following:

By contacting us, you understand that you may share, and we may collect your health information as part of your communication with us.

Verifiable Consumer Request. In order to verify your request to exercise your rights, except for the right to opt out, you must provide sufficient information to allow us to reasonably verify you are the person about whom we collected Personal Information. You must describe your request with sufficient detail to allow us to properly understand, evaluate, and respond to your request.

When we receive your request to exercise your rights: (a) we will acknowledge receipt of your request; (b) we will try to match the information you provide in making the request with information we already maintain; (c) if required to verify your identity, we may ask you to provide additional information, including Personal Information; (d) we will consider various factors when determining how to verify your identity, such as the sensitivity and value of the data, the risk of harm, and the likelihood of fraud.

We will only use the Personal Information we collect during the verification process for the purpose of verifying your identity. If you maintain an account with us, we may use that account to respond to your request and/or verify your identity. If we are unable to verify your identity as required by applicable laws and regulations, we will decline to comply with your request, and let you know why.

When We Will Respond. We will try to respond to your request to exercise your privacy rights within 45 days. If we require additional time, we will inform you of the reason and extension period. For data portability requests, we will select a format to provide you with that Personal Information. We may charge a fee to process or respond to your request if it is excessive, repetitive, or manifestly unfounded.

Who May Exercise Your Rights? You may only make a request to exercise your rights on behalf of yourself. A parent or legal guardian may make a request on behalf of his or her child.

Connecticut residents may submit a request to opt out through an authorized agent. California residents also have the right to submit requests to exercise any privacy right through an authorized agent. You may designate an authorized agent to make a request on your behalf to exercise your rights by doing the following: (1) provide the authorized agent written permission to do so; and (2) verify your own identity (per the process stated above), as well as the identity of the authorized agent directly. We may deny a request from an authorized agent if we do not have proof that they are authorized by you to act on your behalf. We will not require authorized agents to verify your identity to effectuate an opt-out request. We may deny a request from an authorized agent if we do not have proof that they are authorized by you to act on your behalf.

Right to Non-Discrimination. You have the right to not receive discriminatory treatment for exercising any of your privacy.

Additional Terms for California Residents

  • Categories of Personal Information We Have Collected. During the past 12 months, we have collected the following categories of Personal Information: Identifiers, Activity, Sensory Data, Protected Classifications, and Inferences.
  • Categories Of Personal Information Disclosed for A Business Purpose. During the past 12 months, we have disclosed the following categories of Personal Information for a Business Purpose: Identifiers, Protected Classifications, Internet Activity, Sensory Data, and Inferences to the Sources described in this Statement.
  • Sharing Personal Information. In the last 12 months we have not Sold your Personal Information to a third party for monetary compensation. We have Shared Personal Information with third parties for the purposes of serving targeted advertising, including: Identifiers, and Internet Activity to the Sources described in this Statement. As of the date of this Privacy Statement, we no longer Share your Personal Information.
  • We Do Not Use or Disclose Sensitive Information. We do not use or disclose Sensitive Information.

Shine the Light. California's "Shine the Light" law (Civil Code Section § 1798.83) permits users of our Website that are California residents to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes. To make such a request, please send an email to complianceandethicsoffice@lupin.com or write to us at: Lupin Inc., 400 Campus Dr, Somerset, NJ 08873.

APPEAL PROCESS FOR CONNECTICUT RESIDENTS

Right to Seek and Appeal. If you disagree with our refusal to take action on your request to exercise your privacy rights, you have the right to ask us to reconsider. You must submit your request within 60 days of your receipt of our denial. You may submit your request to us by:

By contacting us, you understand that you may share, and we may collect your health information as part of your communication with us.

Appeal Timeframe. Once we receive your request, we will acknowledge and start processing your request. Within 60 days of receiving your request, we will inform you in writing of any action taken or not taken in response to your request, including a written explanation of the reasons for our decision.

 

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What is SOLOSEC?

SOLOSEC® (secnidazole) 2g oral granules is a prescription medicine used to treat bacterial vaginosis in females 12 years of age and older. SOLOSEC is used to treat Trichomoniasis, a common sexually transmitted infection (STI), in people 12 years of age and older. People taking SOLOSEC for Trichomoniasis should avoid having sex until they and their sex partners are treated with the same dose and at the same time, to prevent reinfection. It is not known if SOLOSEC is safe and effective in children under 12 years of age.

How should I take SOLOSEC?

SOLOSEC is a single-dose therapy for oral use. Use SOLOSEC by sprinkling an entire packet of SOLOSEC onto applesauce, yogurt, or pudding. The entire dose should be taken at once, and finished within 30 minutes. Avoid chewing or crunching the granules. SOLOSEC should not be taken by dissolving the granules in any liquid. Avoid drinking alcohol during treatment with SOLOSEC and for 2 days (48 hours) after you take SOLOSEC.

Important Safety Information

  • You should not use SOLOSEC if you've had an allergic reaction to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives or have Cockayne syndrome.
  • Before taking SOLOSEC, tell your healthcare provider about all of your medical conditions, including if you
    • Are pregnant or plan to become pregnant.
    • Are breastfeeding or plan to breastfeed. Breastfeeding is not recommended. You should not breastfeed for 96 hours (4 days) after taking SOLOSEC.
  • Vaginal yeast infections may occur with SOLOSEC and require an antifungal treatment.
  • The most common side effects of SOLOSEC include headache, nausea, vomiting, diarrhea, abdominal pain, vaginal itching and a bad, bitter or metallic taste in your mouth (dysgeusia).
  • Take SOLOSEC exactly as your healthcare provider tells you to. Do not take SOLOSEC more often than it is prescribed.

Call your doctor for medical advice on side effects. You are encouraged to report suspected side effects of prescription drugs to FDA at www.fda.gov/MedWatch also at 1-800-FDA-1088 or contact Lupin Pharmaceuticals, Inc. at 1-844-SOLOSEC (1-844-765-6732).

Please see full prescribing information for SOLOSEC, available here.

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