Adbry Terms and Conditions | Adbry®

Adbry^® Rapid Access™ Program – Program Summary and Terms & Conditions

LEO Pharma Inc. (“LEO Pharma”) is the distributor of Adbry^® (tralokinumab-ldrm) injection (the “Product”). LEO Pharma sponsors the Adbry^® Advocate™ patient access programs (“Adbry Advocate”) which are operated by LEO Pharma’s designated service provider (“LEO Service Provider”). The purpose of Adbry Advocate is to help ensure that medically appropriate patients have access to the medication that has been prescribed for them by their treating healthcare providers (each, an “HCP”).

One of the offerings available for the benefit of patients under Adbry Advocate is the Adbry^® Rapid AccessTM Program (the “Program”). Under the Program, Adbry Advocate will provide the initial (or loading) dose of the Product, consistent with the prescribing information for the Product, without charge, to commercially insured patients who have been prescribed the Product for an approved use and who satisfy the Program eligibility criteria. A patient or their legal representative may enroll in the Program by completing, signing, and submitting the applicable portion of the Adbry Advocate Program Enrollment and Prescription Form. A HCP may prescribe the initial dose of the Product by completing, signing, and submitting the applicable portion of the Enrollment and Prescription Form, which includes a prescription for the Product that will be processed by a non-commercial dispensing pharmacy (“NCDP”) affiliated with the LEO Service Provider. Alternatively, a patient’s HCP may e-prescribe the Product directly to the NCDP, provided the HCP has completed, signed, and submitted an annual Healthcare Provider eRx Program Certification Form. If the HCP e-prescribes the Product directly to the NCDP, the patient or their legal representative must complete, sign, and submit a patient authorization and any other information reasonably requested by the Program in order for Adbry Advocate to verify eligibility and for the patient to receive assistance under the Program.

After the prescription is received by the NCDP and the patient’s eligibility for the Program is verified, the Product may be delivered to the prescribing HCP’s office. Alternatively, if: a) the HCP decides that the patient or caregiver may properly inject the Product; and b) the patient or caregiver received training on the proper preparation and injection of the Product, then the Product may be delivered to the patient’s address of record or other location mutually agreed upon by Adbry Advocate and the patient or patient’s caregiver. In the event of delivery to the prescribing HCP’s office, the Product can usually be delivered in as little as forty-eight (48) hours. In the event of delivery to the patient’s address of record or other mutually agreed upon location, Adbry Advocate will coordinate the shipment of the Product, which may extend the delivery time. Product will be dispensed from the NCDP via overnight delivery.

Eligibility Requirements and Limitations

Patients who have been initiated on therapy with samples are not eligible for Rapid Access Program Product.
The patient must be 12 years of age or older with a valid prescription for an approved use of the Product.
The patient must be a resident of the United States or Puerto Rico.
The patient must have commercial insurance, either directly or through dependent coverage.
The patient must not have prescription drug coverage for the Product, in whole or in part, either directly or through dependent coverage, under any federal or state health program that is a “federal healthcare program” as defined under 42 U.S.C. § 1320a-7b(f), including but not limited to Medicare, Medicaid, TRICARE, the Indian Health Service, the Department of Veterans Affairs Health Benefit Program, state Children’s Health Insurance Programs under the Title XIX or Title XXI of the Social Security Act, state block grant programs under Title V or Title XX of the Social Security Act, or state pharmaceutical assistance programs. This Program is not available for patients within a deductible or similar cost sharing periods under such federal healthcare programs.
Uninsured and cash-paying patients are not eligible.

Additional Terms and Conditions

Good for the initial dose only. Limit of one shipment of Product per eligible patient.
The Program does not constitute insurance.
The provision of the initial dose of Product does not constitute any guarantee of coverage under any prescription benefit insurance or program.
By submitting a request for Product under the Program or by participating in the Program, the HCP acknowledges and agrees that the HCP: (1) will not submit any claim or other request for payment or reimbursement for Product provided under the Program to the patient or any third-party plan or program, including any commercial or government assistance program; (2) will advise the patient that the patient may not submit a claim to any third-party plan or program but should report their receipt of Product to the patient’s insurer if required by their plan; (3) will dispense or administer Product solely to the eligible patient for whom such Product was requested; and (4) will not sell, transfer, or otherwise dispense Product to any other third party.
By submitting a request for Product under the Program or by participating in the Program, the patient (or their legal representative) acknowledges and agrees that the patient: (1) will not submit any claim or other request for payment or reimbursement for Product provided under the Program to any third-party plan or program, including any commercial or government assistance program; (2) will report their receipt of Product to their insurer if required by their plan; and (3) will not sell, transfer, or otherwise dispense Product to any other third party.
The NCDP only dispenses Product pursuant to the Adbry Advocate patient access programs. Product prescriptions subject to third-party insurance, including refill prescriptions, may be dispensed by the pharmacy of the patient’s choice, subject to product distribution and third-party payer limitations.
Patients and/or their HCPs must submit complete information and/or documentation required under the Program and attest to the truthfulness and accuracy of the information and/or documentation.
By submitting a request for Product under the Program or by participating in the Program, the patient (or their legal representative) and the HCP individually acknowledge, understand, and agree to the benefit, eligibility, and other program limitations, terms, and conditions as set forth herein.
The availability of Product under the Program is not conditioned on any past, present, or future purchase, including any potential future refills of Product.
The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) grants individuals rights related to their Protected Health Information (“PHI”). To the extent LEO Pharma receives PHI about you, we will use and disclose it according to the patient authorization that you (or legal representative) have completed for your HCP in connection with the LEO Pharma Adbry Advocate Program. For more information about how your PHI is used and disclosed by your HCP, please review your HCP’s Notice of Privacy Practices. To the extent LEO Pharma collects personal data about you that is not PHI, we will use and disclose that personal data as disclosed in our privacy policy, available at Privacy Policy | LEO Pharma (leo-pharma.us). By participating in the LEO Pharma Adbry Advocate Program, you acknowledge that we may collect health information from you, which may be considered “sensitive” data under some U.S. state laws. Moreover, if you are a parent or guardian of a minor participating in the program, you (or legal representative) acknowledge that we may collect data about the participating minor/s, which may also be considered “sensitive” data under some U.S. state laws.
Offer void where prohibited by law, taxed, or restricted.
LEO Pharma has sole discretion to determine Program eligibility.
LEO Pharma may amend, modify, or terminate Program benefits and eligibility criteria at any time and without notice.

Adbry^® Bridge Care™ Program – Program Summary and Terms & Conditions

LEO Pharma Inc. (“LEO Pharma”) is the distributor of Adbry® (tralokinumab-ldrm) injection (the “Product”). LEO Pharma sponsors the Adbry® Advocate™ patient access programs (“Adbry Advocate”) which are operated by LEO Pharma’s designated service provider (“LEO Service Provider”). The purpose of Adbry Advocate is to help ensure that medically appropriate patients have access to the medication that has been prescribed for them by their treating healthcare provider (“HCP”).

One of the offerings available for the benefit of patients under Adbry Advocate is the Adbry® Bridge Care™ Program (the “Program”). Under the Program, Adbry Advocate will provide the Product, consistent with its prescribing information, without charge and on a periodic basis, to commercially insured patients who have been prescribed the Product for an approved use and who satisfy the Program’s eligibility criteria, after experiencing an “Initial Delay” (defined below) in securing a determination of insurance coverage for the Product. A patient or their legal representative may enroll in the Program by completing, signing, and submitting the applicable portion of the Adbry Advocate Program Enrollment and Prescription Form. A HCP may prescribe the Product by completing, signing, and submitting the applicable portion of the Enrollment and Prescription Form which includes a prescription for the Product that will be processed by a non-commercial dispensing pharmacy (“NCDP”) affiliated with the LEO Service Provider. Alternatively, a patient’s HCP may e-prescribe the Product directly to the NCDP, provided the HCP has completed, signed, and submitted an annual Healthcare Provider eRx Program Certification Form. If the HCP e-prescribes the Product directly to the NCDP, the patient or their legal representative must complete, sign, and submit a patient authorization and any other information reasonably requested by the Program in order for Adbry Advocate to verify eligibility and for the patient to receive assistance under the Program.

After the prescription is received by the NCDP and the patient’s eligibility for the Program is verified, the Product may be delivered to the prescribing HCP’s office. Alternatively, if: a) the HCP decides that the patient or caregiver may properly inject the Product; and b) the patient or caregiver received training on the proper preparation and injection of the Product, then the Product may be delivered to the patient’s address of record or other location mutually agreed upon by Adbry Advocate and the patient or patient’s caregiver. In the event of delivery to the patient’s address of record or other mutually agreed upon location, Adbry Advocate will coordinate the shipment of the Product, which may extend the delivery time. Product will be dispensed from the NCDP via overnight delivery.

Eligibility Requirements and Limitations

The patient must be 12 years of age or older with a valid prescription for an approved use of the Product.
The patient must be a resident of the United States or Puerto Rico.
The patient must have commercial insurance, either directly or through dependent coverage.
The patient must not have prescription drug coverage for the Product, in whole or in part, either directly or through dependent coverage, under any federal or state government subsidized health program that is a “federal healthcare program” as defined under 42 U.S.C. § 1320a-7b(f), including but not limited to Medicare, Medicaid, TRICARE, the Indian Health Service, the Department of Veterans Affairs Health Benefits program, state Children’s Health Insurance Programs under the Title XIX or Title XXI of the Social Security Act, state block grant programs under Title V or Title XX of the Social Security Act, or state pharmaceutical assistance programs. This Program is not available for patients within a deductible or similar cost sharing periods under such federal healthcare programs.
Uninsured and cash-paying patients are not eligible.
The patient must experience an “Initial Delay”, which is defined as either:
- A delay of more than seven (7) business days in securing an insurance coverage determination (i.e., the actual submission of a request for coverage determination, such as a prior authorization request), either at therapy initiation or in connection with a change in insurance provider or coverage (i.e., due to a change in employment); or
- A denial of insurance coverage based on a prior authorization request – either at therapy initiation or in connection with a change in insurance provider or coverage (i.e., due to a change in employment), for which an appeal (or subsequent appeal) of the coverage denial, on behalf of the patient, has been submitted or will be submitted within thirty (30) days of such denial.

Additional Terms and Conditions

The Program does not constitute insurance.
The provision of Product under the Program does not constitute any guarantee of coverage under any prescription benefit insurance or program.
For each eligible patient, the Program provides Product for such patient without charge, for a maximum of six (6) months of shipment of Product, on a periodic basis, within a twenty-four (24) month consecutive time period commencing on the initial date of dispense for such patient’s lifetime, or until such patient receives insurance coverage approval, whichever occurs earlier. After eligibility is verified and the prescription is received by the NCDP, the NCDP will ship a supply of Product, in amounts to be determined in the sole discretion of Adbry Advocate, to the prescribing HCP’s office, or to the patient, as explained above.
On a regular basis, Adbry Advocate will verify whether the patient has secured a coverage determination or, if a noncoverage determination has been issued, whether the patient has submitted an appeal. The NCDP will ship additional supplies of Product, in amounts to be determined in the sole discretion of Adbry Advocate, provided the patient remains eligible to receive Product under the Program.
By submitting a request for Product under the Program or by participating in the Program, the HCP acknowledges and agrees that the HCP: (1) will not submit any claim or other request for payment or reimbursement for Product provided under the Program to the patient or any third-party plan or program, including any commercial or government assistance program; (2) will advise the patient that the patient may not submit a claim to any third-party program or plan but should report their receipt of Product to the patient’s insurer if required by their plan; (3) will dispense or administer Product solely to the eligible patient for whom such Product was requested; and (4) will not sell, transfer, or otherwise dispense Product to any other third party.
By submitting a request for Product under the Program or by participating in the Program, the patient (or their legal representative) acknowledges and agrees that the patient: (1) will not submit any claim or other request for payment or reimbursement for Product provided under the Program to any third-party plan or program, including any commercial or government assistance program; (2) will report their receipt of Product to their insurer if required by their plan; and (3) will not sell, transfer, or otherwise dispense Product to any other third party.
The NCDP only dispenses Product pursuant to the Adbry Advocate patient access programs. Product prescriptions subject to third-party insurance, including refill prescriptions, may be dispensed by the pharmacy of the patient’s choice, subject to product distribution and third-party payer limitations.
Patients and/or their HCPs must submit complete information and/or documentation required under the Program and attest to the truthfulness and accuracy of the information and/or documentation. Patients may be asked to reverify insurance coverage or appeal status during their participation in the Program. Failure to verify status or to file a required appeal may result in termination of the dispensing of Product under the Program in the sole discretion of Adbry Advocate.
By submitting a request for Product under the Program or by participating in the Program, the patient (or their legal representative) and the HCP individually acknowledge, understand, and agree to the benefit, eligibility, and other program limitations, terms and conditions as set forth herein.
The availability of Product under the Program is not conditioned on any past, present, or future purchase, including any potential future refills of Product.
The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) grants individuals rights related to their Protected Health Information (“PHI”). To the extent LEO Pharma receives PHI about you, we will use and disclose it according to the patient authorization that you (or legal representative) have completed for your HCP in connection with the LEO Pharma Adbry Advocate Program. For more information about how your PHI is used and disclosed by your HCP, please review your HCP’s Notice of Privacy Practices. To the extent LEO Pharma collects personal data about you that is not PHI, we will use and disclose that personal data as disclosed in our privacy policy, available at Privacy Policy | LEO Pharma (leo-pharma.us). By participating in the LEO Pharma Adbry Advocate Program, you acknowledge that we may collect health information from you, which may be considered “sensitive” data under some U.S. state laws. Moreover, if you are a parent or guardian of a minor participating in the program, you acknowledge that we may collect data about the participating minor/s, which may also be considered “sensitive” data under some U.S. state laws.
Offer void where prohibited by law, taxed, or restricted.
LEO Pharma has sole discretion to determine Program eligibility.
LEO Pharma may unilaterally amend, modify, or terminate Program benefits and eligibility criteria at any time without notice.

Adbry^® Copay Program – Program Summary and Terms & Conditions

LEO Pharma Inc. (“LEO Pharma”) is the distributor of Adbry® (tralokinumab-ldrm) injection (the “Product”). LEO Pharma sponsors the Adbry® Advocate™ patient access programs (“Adbry Advocate”), which are operated by LEO Pharma’s designated service provider. The purpose of Adbry Advocate is to help ensure that medically appropriate patients have access to the medication that has been prescribed for them by their treating healthcare provider (“HCP”).

The Adbry® Copay Program (the “Program”) will provide reimbursement for eligible, commercially insured patients’ cost-sharing obligations (including deductibles, copayments, coinsurance, or amounts in excess of out-of-pocket maximums) for the Product, up to an annual maximum limitation specified by the Program and as may be adjusted from time to time in the Program’s sole discretion. The amount of reimbursement may vary, including based on an eligible patient’s insurance coverage. Patients may pay as little as $0 per fill of the Product after application of Program reimbursement. Patients remain responsible for any remaining costs for the Product after application of Program reimbursement or reaching the annual maximum limitation.

A patient or their legal representative may enroll in the Copay Program either by enrolling in Adbry Advocate or via other means provided by LEO Pharma, such as via the Product website or via specialty pharmacies contracted with LEO Pharma to dispense the Product.

Eligibility Requirements and Limitations

The current annual maximum benefit available under the Program is thirteen thousand U.S. dollars ($13,000.00) per eligible patient.
The patient must be 12 years of age or older with a valid prescription for an approved use of the Product.
The patient must be a resident of the United States or Puerto Rico.
The patient must have commercial insurance, either directly or through dependent coverage.
The patient must not have prescription drug coverage for the Product, in whole or in part, either directly or through dependent coverage, under any federal or state health program that is a “federal healthcare program” as defined under 42 U.S.C. § 1320a-7b(f), including but not limited to Medicare, Medicaid, TRICARE, the Indian Health Service, the Department of Veterans Affairs Health Benefit Program, state Children’s Health Insurance Programs under the Title XIX or Title XXI of the Social Security Act, state block grant programs under Title V or Title XX of the Social Security Act, or state pharmaceutical assistance programs. This Program is not available for patients within a deductible or similar cost sharing periods under such federal healthcare programs.
Uninsured and cash-paying patients are not eligible.

Additional Terms and Conditions

The Program does not constitute insurance.
The availability of benefits under the Program does not constitute any guarantee of coverage under any prescription benefit insurance or program.
The benefits under this Program may not be combined with any third-party rebate, coupon, or offer.
By submitting a request for benefits under the Program or by participating in the Program, the HCP acknowledges and agrees that the HCP: (1) will not submit any claim or other request for payment or reimbursement for benefits provided under the Program to the patient or any third-party plan or program, including any commercial or government assistance program; and (2) will advise the patient that the patient may not submit a claim to any third-party plan or program but should report their receipt of benefits to the patient’s insurer if required by their plan.
By submitting a request for benefits under the Program or by participating in the Program, the patient (or their legal representative) acknowledges and agrees that the patient: (1) will not submit any claim or other request for payment or reimbursement for benefits provided under the Program to any third-party plan or program, including any commercial or government assistance program; and (2) will report their receipt of benefits to their insurer if required by their plan.
Patients and/or their HCPs must submit complete information and/or documentation required under the Program and attest to the truthfulness and accuracy of the information and/or documentation.
By submitting a request for benefits under the Program or by participating in the Program, the patient (or their legal representative) and HCP individually acknowledge, understand, and agree to the benefit, eligibility, and other program limitations, terms, and conditions as set forth herein.
The availability of benefits under the Program is not conditioned on any past, present, or future purchase, including any potential future refills of Product.
The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) grants individuals rights related to their Protected Health Information (“PHI”). To the extent LEO Pharma receives PHI about you, we will use and disclose it according to the patient authorization that you (or legal representative) have completed for your HCP in connection with the LEO Pharma Adbry Advocate Program. For more information about how your PHI is used and disclosed by your HCP, please review your HCP’s Notice of Privacy Practices. To the extent LEO Pharma collects personal data about you that is not PHI, we will use and disclose that personal data as disclosed in our privacy policy, available at Privacy Policy | LEO Pharma (leo-pharma.us). By participating in the LEO Pharma Adbry Advocate Program, you acknowledge that we may collect health information from you, which may be considered “sensitive” data under some U.S. state laws. Moreover, if you are a parent or guardian of a minor participating in the program, you (or legal representative) acknowledge that we may collect data about the participating minor/s, which may also be considered “sensitive” data under some U.S. state laws.
The copay card, whether issued virtually or physically, has no cash value.
Offer void where prohibited by law, taxed, or restricted.
LEO Pharma has sole discretion to determine Program eligibility.
LEO Pharma may unilaterally amend, modify, or terminate Program benefits and eligibility criteria at any time and without notice.

Adbry^® Patient Assistance Program – Program Summary and Terms & Conditions

LEO Pharma Inc. (“LEO Pharma”) is the distributor of Adbry® (tralokinumab-ldrm) injection (the “Product”). LEO Pharma sponsors the Adbry® Advocate™ patient access programs (“Adbry Advocate”) which are operated by LEO Pharma’s designated service provider (“LEO Service Provider”). The purpose of Adbry Advocate is to help ensure that medically appropriate patients have access to the medication that has been prescribed for them by their treating healthcare provider (“HCP”).

One of the offerings available for the benefit of patients under Adbry Advocate is the Adbry® Patient Assistance Program (the “Program” or “PAP”). Under the Program, Adbry Advocate will provide the Product, without charge, to patients who: a) demonstrate financial need; and b) do not have insurance for the Product or who are underinsured, and who otherwise satisfy the eligibility requirements for the Program. Adbry Advocate will provide the Product without charge to eligible patients on a periodic basis and consistent with the prescribing information for the Product. A patient or their legal representative may enroll in the Program by completing, signing, and submitting the applicable portion of the Adbry Advocate Program Enrollment and Prescription Form. A HCP may prescribe the Product by completing, signing, and submitting the applicable portion of the Enrollment and Prescription Form which includes a prescription for the Product that will be processed by a non-commercial dispensing pharmacy (“NCDP”) affiliated with the LEO Service Provider. Alternatively, a patient’s HCP may e-prescribe the Product directly to the NCDP, provided the HCP has completed, signed, and submitted an annual Healthcare Provider eRx Program Certification Form. If the HCP e-prescribes the Product directly to the NCDP, the patient or their legal representative must complete, sign, and submit a patient authorization and any other information reasonably requested by the Program in order for Adbry Advocate to verify eligibility and for the patient to receive assistance under the Program. A patient requesting assistance under the PAP (or their legal representative) is also required to submit information and documentation concerning household size and income and insurance status to allow Adbry Advocate to evaluate the patient’s eligibility under the Program.

After the prescription is received by the NCDP and the patient’s eligibility for the Program is verified, the Product may be delivered to the prescribing HCP’s office. Alternatively, if: a) the HCP decides that the patient or caregiver may properly inject the Product; and b) the patient or caregiver received training on the proper preparation and injection of the Product, then the Product may be delivered to the patient’s address of record or other location mutually agreed upon by Adbry Advocate and the patient or patient’s caregiver. In the event of delivery to the patient’s address of record or other mutually agreed upon location, Adbry Advocate will coordinate the shipment of the Product, which may extend the delivery time. Product will be dispensed from the NCDP via overnight delivery.

Eligibility Requirements and Limitations

The patient must be 12 years of age or older with a valid prescription for the Product.
The patient must be a resident of the United States or Puerto Rico.
The patient’s annual household income must be less than or equal to four hundred percent (400%) of the federal poverty level for the applicable household size.
The patient either: (a) has Medicare Part D coverage and has applied for and been denied the Low Income Subsidy (“LIS”) from the Social Security Administration and meets the further conditions below; or (b) has no insurance coverage, no benefits for prescription medicines, or the patient’s insurance plan has formally denied coverage for the Product through a written coverage policy or a written decision as part of a benefits inquiry or prior authorization process and has provided a copy of the denial.
The patient must not have insurance coverage for the Product, in whole or in part, either directly or through dependent coverage, under any federal or state government-subsidized health program that is a “federal healthcare program” as defined under 42 U.S.C. § 1320a-7b(f), including, but not limited to, Medicare, Medicaid, TRICARE, the Indian Health Service, the Department of Veterans Affairs Health Benefits, state Children’s Health Insurance Programs under the Title XIX or Title XXI of the Social Security Act, state block grant programs under Title V or Title XX of the Social Security Act, or state pharmaceutical assistance programs, except that, if the patient is a Medicare Part D enrollee, the patient may be eligible if the patient has applied for and been denied the LIS and meets the further conditions below. This Program is not available for patients within a deductible or similar cost sharing periods under such federal healthcare programs.
If the patient is a Medicare Part D enrollee that has been denied the LIS, the patient is subject to the following additional conditions in order to receive assistance under the Program: (1) the patient shall not submit any claim for reimbursement for the Product to any third party, including a Medicare Part D plan or another public or private plan or program, during the period of assistance; (2) the cost of the Product shall not apply or be applied toward the patient’s Medicare Part D True Out-of-Pocket Costs; (3) the patient must inform their Medicare Part D plan about enrollment in the Program and that the patient will receive the Product for free under the Program for the remainder of the coverage year; (4) the patient must spend at least four percent (4%) of their annual household income on prescription medications covered through the Part D plan in the current calendar year; and (5) the patient must receive free Product through the Program through the end of the calendar year in which assistance is first provided, even if the patient’s use of the Product is periodic during the year.
Eligible patients without Medicare Part D coverage will receive up to twelve (12) months of Product without charge from the date of enrollment. Eligible patients with Medicare Part D coverage will receive Product through the end of the coverage year. Annual re-enrollment is required.
If the patient may be eligible for Medicaid, either directly or through dependent coverage, then the patient (or their legal representative) is required to provide documentation of Medicaid denial before being assessed for Program eligibility.

Additional Terms and Conditions

The Program does not constitute insurance.
The provision of Product does not constitute any guarantee of coverage under any prescription benefit insurance or program.
By submitting a request for Product under the Program or by participating in the Program, the HCP acknowledges and agrees that the HCP: (1) will not submit any claim or other request for payment or reimbursement for Product provided under the Program to the patient or any third-party plan or program, including any commercial or government assistance program; (2) will advise the patient that the patient may not submit a claim to any third-party program or plan but should report their receipt of Product to the patient’s insurer if required by their plan; (3) will dispense or administer Product solely to the eligible patient for whom such Product was requested; and (4) will not sell, transfer, or otherwise dispense Product to any other third party.
By submitting a request for Product under the Program or by participating in the Program, the patient (or their legal representative) acknowledges and agrees that the patient: (1) will not submit any claim or other request for payment or reimbursement for Product provided under the Program to any third-party plan or program, including any commercial or government assistance program; (2) will report their receipt of Product to their insurer if required by their plan; and (3) will not sell, transfer, or otherwise dispense Product to any other third party.
The NCDP only dispenses Product pursuant to the Adbry Advocate patient access programs. Product prescriptions subject to third-party insurance, including refill prescriptions, may be dispensed by the pharmacy of the patient’s choice, subject to product distribution and third-party payer limitations.
Patients and/or their HCPs must submit complete information and/or documentation required under the Program and attest to the truthfulness and accuracy of the information and/or documentation.
By submitting a request for Product under the Program or by participating in the Program, the patient (or their legal representative) and the HCP individually acknowledge, understand, and agree to the benefit, eligibility, and other program limitations, terms, and conditions as set forth herein.
The Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) grants individuals rights related to their Protected Health Information (“PHI”). To the extent LEO Pharma receives PHI about you, we will use and disclose it according to the patient authorization that you (or legal representative) have completed for your HCP in connection with the LEO Pharma Adbry Advocate Program. For more information about how your PHI is used and disclosed by your HCP, please review your HCP’s Notice of Privacy Practices. To the extent LEO Pharma collects personal data about you that is not PHI, we will use and disclose that personal data as disclosed in our privacy policy, available at Privacy Policy | LEO Pharma (leo-pharma.us). By participating in the LEO Pharma Adbry Advocate Program, you (or legal representative) acknowledge that we may collect health information from you, which may be considered “sensitive” data under some U.S. state laws. Moreover, if you are a parent or guardian of a minor participating in the program, you acknowledge that we may collect data about the participating minor/s, which may also be considered “sensitive” data under some U.S. state laws.
The availability of Product under the Program is not conditioned on any past, present, or future purchase, including any potential future refills of Product.
Offer void where prohibited by law, taxed, or restricted.
LEO Pharma has sole discretion to determine Program eligibility.
LEO Pharma may unilaterally amend, modify, or terminate Program benefits and eligibility criteria at any time and without notice.

Medisafe – Terms of Use

Welcome!

The content in the Adbry® Digital Companion (“Adbry Digital Companion”), is owned by LEO Pharma Inc. or its affiliates (“LEO Pharma”). The content in the Adbry Digital Companion is intended only for patients and caregivers of patients taking ADBRY® (tralokinumab-ldrm) injection, for subcutaneous use consistent with the U.S. Food and Drug Administration (“FDA”) approved labeling.

We have drafted these Terms of Use (“Terms”) to help you understand the rules that govern your use of the Adbry Digital Companion. If you do not agree to abide by all of the provisions contained in these Terms, you may not use or access the Resource Center. The Adbry Digital Companion is a digital companion within the Medisafe mobile device application (the “App”) and these Terms are in addition to any terms and conditions of Medisafe regarding use of the App. These Terms constitute an enforceable legal agreement between you and LEO Pharma regarding your use of or access to The Experience. If you do not accept these Terms, then you are not granted permission to use or access the Resource Center. LEO Pharma reserves the right to terminate your use or access for any reason without giving you advanced notice.

LEO Pharma reserves the right to modify these Terms at any time at its sole discretion. You should check the Adbry Digital Companion from time to time to review the then current Terms because it is binding on you. Your continued use of the Adbry Digital Companion constitutes your acceptance of any changes to the Terms.

These Terms were last updated on January 3, 2022.

1. Scope

The content in the Adbry Digital Companion is intended only for U.S. residents. We control and operate this Adbry Digital Companion from the United States of America. If you are a non-US resident, you may access this Adbry Digital Companion solely at your own risk and are responsible for compliance with local laws and regulations, if applicable. Any references to products or services on the Adbry Digital Companion do not imply that LEO Pharma intends to announce or offer these products or services in your country.

2. Privacy

The Adbry Digital Companion may collect personal information about you as part of the services provided to you. Personal information that is collected will be processed in accordance with the terms in the Privacy Policy which you can view here: www.medisafe.com/privacy-policy.

3. Adbry Digital Companion Access

LEO Pharma reserves the right to limit access to certain areas of the Adbry Digital Companion to certain users who meet the qualifications imposed by us. We reserve the right to discontinue access to any restricted area of the Adbry Digital Companion at any time, without notice to you, for any reason.

4. Modifications to Resource Center

LEO Pharma reserves the right to modify or discontinue the Adbry Digital Companion (or any portion of the Resource Center), temporarily or permanently, with or without notice to you, and is not obligated to support or update the Resource Center. LEO Pharma shall not be liable to you or any third party in the event that LEO Pharma exercises its right to modify or discontinue the Adbry Digital Companion (or any portion of the Resource Center). Unless explicitly stated otherwise, any new features that augment or enhance the current Adbry Digital Companion shall be subject to these Terms.

5. No Medical Advice

The information on this Adbry Digital Companion is provided for general informational purposes only and is not intended or recommended as a substitute for professional medical advice. Always seek the advice of your physician or other qualified healthcare provider regarding any medical condition or treatment.

6. Intellectual Property Rights

The entire content included in the Resource Center, including without limitation, the text, design, graphics, interface, sounds, music, video, interactive features and the like and the selection and arrangement thereof (“Content”) and the trademarks, service marks and logos contained therein (“Marks”), are owned by or licensed to LEO Pharma, its affiliates or subsidiaries, and are subject to copyright, trademark and other intellectual property rights under United States and foreign laws and international conventions.

All Content on the Adbry Digital Companion is provided to you AS IS for your information and personal use only.

You may download, view, copy and print Content, subject to the following conditions:
the Content may be used solely for personal, informational, or internal business purposes;
any and all copyright, trademark and other proprietary rights notices must appear on all copies, including the copyright notice at the bottom of the page;
the Content may not be modified or altered in any way; and
no graphics may be used separate from accompanying text.

Except as provided above, you may not use, download, upload, copy, print, display, perform, reproduce, publish, license, post, transmit, frame, mirror on another Web service, use any meta tags, inline any graphics or distribute any Content or information from the Adbry Digital Companion in whole or in part without the express permission of LEO Pharma. Requests for such permission should be made by contacting us. Any rights not expressly granted herein are reserved.

7. Prohibited Uses Generally

You shall not:

delete or revise any material or other information of any other user or LEO Pharma;
take any action that imposes an unreasonable or disproportionately large load on the Resource Center’s infrastructure;
use any device, software or routine to interfere or attempt to interfere with the proper working of the Adbry Digital Companion or any activity being conducted on the Resource Center; or
attempt to decipher, decompile, disassemble or reverse-engineer any of the software comprising or in any way making up a part of the Resource Center.

You further agree not to violate or attempt to violate the security of the Resource Center. Violations of system or network security may result in civil or criminal liability. In accordance with these Terms, LEO Pharma will investigate and work with law enforcement authorities to prosecute users who are involved in such violations.

8. Third-Party Content and Links to Third-Party Websites

This Adbry Digital Companion is accessible through the App for medication management. LEO Pharma is not responsible for, and does not control, monitor, or endorse, any content on the App that is not located within the Resource Center, including, but not limited to, any content created by Medisafe related to LEO Pharma’s Products. Please refer to the separate terms of use, privacy policies, and other rules for use of the App itself. In addition, the Adbry Digital Companion may provide links to other Websites operated by Pharma as well as Websites operated by third parties. Please refer to the separate terms of use, privacy policies, and other rules posted on these linked sites before you use them. Third-party links are provided merely as a convenience to you, and the inclusion of any link does not imply affiliation or endorsement by LEO Pharma. LEO Pharma does not review, monitor or check the accuracy of content published on third-party sites, and is not responsible for the availability of, and content provided on, third-party sites. If you choose to purchase any products or services from a third party, including Medisafe, your relationship is directly with the third party and LEO Pharma is not responsible for any loss or damage of any sort you may incur from dealing with any third party.

9. Disclaimer of Warranties

THE APP AND ADBRY DIGITAL COMPANION AND ALL CONTENT, MATERIALS, INFORMATION, PRODUCTS AND SERVICES PROVIDED THEREIN, ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS. LEO PHARMA EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, AND SECURITY AND ACCURACY, AS WELL AS ALL WARRANTIES ARISING BY USAGE OF TRADE, COURSE OF DEALING, OR COURSE OF PERFORMANCE. LEO PHARMA MAKES NO WARRANTY THAT: (A) THE APP OR ADBRY DIGITAL COMPANION WILL MEET YOUR REQUIREMENTS; (B) THE APP OR ADBRY DIGITAL COMPANION WILL BE AVAILABLE ON AN UNINTERRUPTED, TIMELY, SECURE, OR ERROR-FREE BASIS; (C) THE RESULTS THAT MAY BE OBTAINED FROM THE USE OF THE APP OR ADBRY DIGITAL COMPANION OR ANY SERVICES OFFERED THROUGH THE APP OR ADBRY DIGITAL COMPANION WILL BE ACCURATE OR RELIABLE; OR (D) THE QUALITY OF ANY PRODUCTS, SERVICES, INFORMATION, OR OTHER MATERIAL OBTAINED BY YOU THROUGH THE APP OR ADBRY DIGITAL COMPANION WILL MEET YOUR EXPECTATIONS.

ANY CONTENT, MATERIALS, OR INFORMATION DOWNLOADED OR OTHERWISE OBTAINED THROUGH THE USE OF THE APP OR ADBRY DIGITAL COMPANION IS DONE AT YOUR OWN DISCRETION AND RISK. LEO PHARMA SHALL HAVE NO RESPONSIBILITY FOR ANY DAMAGE TO YOUR COMPUTER SYSTEM OR LOSS OF DATA THAT RESULTS FROM THE DOWNLOAD OF ANY CONTENT, MATERIALS, OR INFORMATION.

NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY YOU FROM LEO PHARMA OR THROUGH THE APP OR ADBRY DIGITAL COMPANION SHALL CREATE ANY WARRANTY NOT EXPRESSLY MADE HEREIN.

10. Limitation of Liability

IN NO EVENT SHALL LEO PHARMA BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES, OR DAMAGES FOR LOSS OF PROFITS, REVENUE, DATA OR USE, INCURRED BY YOU OR ANY THIRD PARTY, WHETHER IN AN ACTION IN CONTRACT OR TORT, ARISING FROM YOUR ACCESS TO, OR USE OF, THE APP OR ADBRY DIGITAL COMPANION OR ANY SERVICES PROVIDED THROUGH THE APP OR RESOURCE CENTER, OR IN CONNECTION WITH ANY FAILURE OF PERFORMANCE, ERROR, OMISSION, INTERRUPTION, DEFECT, DELAY IN OPERATION OR TRANSMISSION, COMPUTER VIRUS, OR LINE OR SYSTEM FAILURE. IN THE EVENT THAT YOU HAVE A DISPUTE WITH ANOTHER USER RELATED TO, ARISING FROM, OR IN ANY WAY CONNECTED WITH USE OF THE APP OR RESOURCE CENTER, YOU RELEASE PHARMA FROM ANY CLAIMS, DEMANDS, AND DAMAGES OF EVERY KIND AND NATURE ARISING OUT OF OR IN ANY WAY CONNECTED WITH SUCH A DISPUTE.

These limitations apply whether the alleged liability is based on contract, tort, negligence, strict liability, or any other basis, even if LEO Pharma has been advised of the possibility of such damage. Because some jurisdictions do not allow the exclusion or limitation of incidental or consequential damages, LEO Pharma’s liability in such jurisdictions shall be limited to the extent permitted by law.

12. No Resale of the Resource Center

Your right to use the Adbry Digital Companion is personal to you. You agree not to reproduce, duplicate, copy, sell or resell the Resource Center, without the express written consent of LEO Pharma.

13. Indemnity

You agree to indemnify, defend and hold LEO Pharma, its parents, subsidiaries, affiliates, shareholders, directors, officers, employees and agents, harmless from any claim, demand, liability, expense, or loss, including reasonable attorneys’ fees, made by any third party due to or arising out of, or in any way connected with your use of or access to the Adbry Digital Companion or your violation of these Terms.

14. Export Restrictions/Legal Compliance

LEO Pharma controls this Adbry Digital Companion from within the United States of America. You may not access, download, use or export the Adbry Digital Companion or the Content in violation of US export laws or regulations, or in violation of any other applicable laws or regulations.

15. Choice of Law and Forum

These Terms shall be governed by and construed in accordance with the laws of the State of New Jersey without regard to its choice of law provisions. All disputes arising from or relating to these Terms shall be brought in a court of competent jurisdiction in the State of New Jersey. YOU AGREE THAT ANY CAUSE OF ACTION BROUGHT BY YOU AND ARISING OUT OF OR RELATED TO YOUR USE OF THE ADBRY DIGITAL COMPANION MUST COMMENCE WITHIN ONE (1) YEAR AFTER THE CAUSE OF ACTION ACCRUES, EXCEPT THAT LEO PHARMA MAY COMMENCE ANY SUCH ACTION IN ACCORDANCE WITH THE APPLICABLE STATUTE OF LIMITATIONS UNDER NEW JERSEY LAW. OTHERWISE, SUCH CAUSE OF ACTION IS PERMANENTLY BARRED.

16. Termination

LEO Pharma reserves the right, in its sole discretion, to terminate your access to and use of the Resource Center, with or without notice. Otherwise applicable sections of the Agreement shall survive termination.

17. No Waiver

The failure of LEO Pharma to enforce any provisions of the Terms or respond to a breach by you or other parties shall not in any way waive its right to enforce subsequently any terms or conditions of the Agreement or to act with respect to similar breaches.

18. Miscellaneous

You agree that no joint venture, partnership, employment, or agency relationship exists between you and LEO Pharma as a result of these Terms or your access to and use of the Resource Center. A printed version of the Terms and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to the Terms to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form. Unless otherwise specified herein, the Terms constitutes the entire agreement between you and LEO Pharma and governs your use of the Resource Center. If any portion of the Terms is held invalid or unenforceable, that portion shall be construed in a manner consistent with applicable law to reflect, as nearly as possible, the original intention of the parties, and the remaining portions shall remain in full force and effect.

LEO Pharma may assign its rights and duties under these Terms without such assignment being considered a change to the Terms and without notice to you. You may not assign these Terms without the prior written consent of LEO Pharma. These Terms shall inure to the benefit of and be binding upon each party’s successors and permitted assigns.

Privacy Policy for Use of the Adbry® Digital Companion on Medisafe

January 3, 2022

LEO Pharma Inc. (“we,” “our” or “us”) is the U.S. affiliate of the Denmark-based LEO Pharma A/S, a global leader in dermatology. This Privacy Policy explains how we use and disclose the information we collect from you through the Adbry Digital Companion hosted by Medisafe (the “Digital Companion”).

This Privacy Policy applies to information collected through the Digital Companion and does not apply to any other areas of the Medisafe application, or other products, services, or platforms that may support or interact with the Digital Companion. Please visit the Medisafe privacy policy at www.medisafe.com/privacy-policy to find more information on Medisafe’s data processing activities in these other areas.

What Information Do We Collect?

Information We Obtain From You or From the Support Services You Are Enrolled In: We collect the categories of information listed below through your use of the Digital Companion, or from LEO Pharma Support Services that integrate with the Digital Companion when you enroll. These Support Services may include your medication patient support program, co-pay program or other medication or financial assistance program (“Support Services”). The information that we collect from you may include:

Contact information: First name, last name, email address, phone number, zip code, mailing address;
Demographic information, including your age, birth date, and gender;
Account information, including your username and password;
Medical or health information, including your prescription medication, dosage, renewal dates, appointment dates, and information about your engagement with symptoms tracking features;
Insurance and payment information, including insurance and benefits information, program enrollment, co-pay balance, co-pay renewal, and copay card information;
Information you choose to provide outside of the Digital Companion, for example, if you send us an inquiry using the contact information provided below or otherwise make a customer service inquiry associated with the Digital Companion.
If you submit personal information relating to other people to us, you represent that you have the authority to do so and to permit us to use the information in accordance with this Privacy Policy.
Information That We Automatically Collect From You: When you download and use the Digital Companion, we and our service providers may automatically collect usage data as well as technical data about your device.

We collect this information about you by using cookies and other similar technologies. Please refer to the section below on “Cookies and Similar Technologies” for more details. This automatically collected information may include:
Internet or other electronic network activity information, such as the date and time the Digital Companion accesses our servers and what information and files have been downloaded to the Digital Companion.
Device Information, including certain information that is collected by most browsers or automatically through your device, such as your Media Access Control (MAC) address, screen resolution, operating system name and version, device manufacturer and model, language, Internet browser type and version and the name and version of the Digital Companion you are using.
App Usage Data, for example, when you download and use the Digital Companion, we may track and collect app usage data, such as the date and time the app on your device accesses our servers and the information and files that have been downloaded to the app.
IP Address, which is a number that is automatically assigned to the computer you are using by your Internet Service Provider. An IP Address may be identified and logged automatically in our server log files whenever a user accesses the Digital Companion, along with the time of the visit and the page(s) visited. Collecting IP addresses is standard practice and is done automatically by many websites, applications and other services.

Cookies and Similar Technologies:

Cookies are small text files stored directly on your device. We use cookies to collect information such as time spent on the Digital Companion, pages visited, pages you view immediately before and after you access the Digital Companion, the search terms you enter, and other anonymous traffic data. Cookies allow us to recognize you and personalize your Digital Companion, to facilitate navigation, and to display information more effectively. We also use cookies to gather statistical information about the use of the Digital Companion in order to understand how it is used, improve it, and resolve questions about it. If you do not want information collected through the use of cookies, most browsers allow you to automatically decline cookies or to be given the choice of declining or accepting cookies from a particular site. You may wish to refer to allaboutcookies.org/how-to-manage-cookies. If you do not accept our cookies, you may experience some inconvenience in your use of the Digital Companion.
Pixel Tags: We may use pixel tags (also known as web beacons and clear GIFs) to, among other things, track the actions of users of the Digital Companion and our email recipients, measure the success of our marketing campaigns and compile statistics about usage of the Digital Companion and response rates.

How Do We Use Your Information?

We will use the information that you provide to deliver the Digital Companion to you, including account registration or verification, providing updates about your insurance benefits, medication shipment, or co-pay details, helping you assess and maintain adherence to your medication regimen, as well as content and interactive features.

In addition to using your information to provide the Digital Companion as described above, and to deliver programs, services, products, or information that you request, we may use your information to:

to verify your identity when you access your account with the Digital Companion and ensure the security of your personal information;
to provide customer support, account management services, and to engage in system maintenance;
to answer your questions about the services, or otherwise communicate with you about the Digital Companion;
to provide you with information about the Digital Companion, our other products, programs, or services, your accounts, and notices;
to deliver targeted ads and other marketing communications that may be of interest to you;
ensure that the offerings function properly;
to permit you to participate in polls, surveys, promotions, or other interactive features;
to personalize your Digital Companion and better tailor content to you, such as by providing interactive or personalized elements on the Digital Companion and providing you with content based on your interests and requests;
to help us, our subsidiaries, affiliates, and business partners better understand our audiences, evaluate user interest in the Digital Companion, improve the Digital Companion, and perform other market research activities;
support other business purposes, such as data analysis; audits; monitoring and prevention of fraud, infringement, and other potential misuse of the Digital Companion; modifying the Digital Companion; determining the effectiveness of our promotional campaigns; and operating and expanding our business activities, including the development of new products and services; and
as we believe to be necessary or appropriate: (a) under applicable law, including laws outside your country of residence; (b) to comply with legal processes; (c) to respond to requests from public and government authorities, including public and government authorities outside your country of residence; (d) to enforce our terms and conditions; (e) to protect our operations or those of any of our affiliates; (f) to protect our rights, privacy, safety, or property, and/or that of our affiliates, you, or others; and (g) to allow us to pursue available remedies or limit the damages that we may sustain.

In addition to those purposes listed above, we may use your information for any other purpose disclosed to you at the time of collection or when you provide your authorization.

How We Protect Your Information

We take the security of your personal information seriously. We use reasonable administrative, physical, and technical safeguards to secure the personal information you share with us. However, no security safeguards are 100% secure and we cannot guarantee the security of your personal information.

When and to Whom Do We Disclose Your Information?

The information we collect from and about you may be disclosed:

to our subsidiaries and affiliates within LEO Pharma, for the purposes described in this Privacy Policy;
to third parties that provide services to us, such as fulfilling requests for information, answering calls, administering programs or projects, assisting in research and development, or delivering advertisements or other communications;
to third parties who offer products or services jointly with us or with our subsidiaries or affiliates;
as required by law, such as to law enforcement, to health authorities to report possible adverse events, during government inspections or audits, as ordered or directed by courts or other governmental agencies, or in order to comply with a subpoena or other legal process;
when we believe in good faith that disclosure is necessary to protect legal rights or the security or integrity of the Digital Companion; protect your safety or the safety of others; investigate fraud, a breach of contract, or a violation of law; or respond to a government request; and
to third parties, advisors, and other entities to the extent reasonably necessary for development of or to proceed with the negotiation or completion of a corporate or commercial transaction, including a reorganization, merger, acquisition, joint venture, sale, or other disposition of all or a portion of our business, assets, or stock (including in connection with any bankruptcy or similar proceedings).

We may use or disclose information that does not personally identify you for any purpose, except where we are required to do otherwise under applicable law.

How Long Will We Retain Your Information

We will retain your personal information for as long as is necessary to fulfill the purpose for which it was collected (or for any subsequent purpose that is compatible with the original purpose). We may also retain personal information for the period during which a claim may be made in relation to our dealings with you. In general terms, this will mean that your personal information will be kept for the duration of our relationship with you and (i) the period required by tax and other laws and regulations; and (ii) any statutory limitation period under applicable laws. In certain circumstances, data may need to be retained for a longer period of time (e.g., ongoing correspondence or a continuing claim or investigation).

LEO Pharma Inc. is based in the United States and the personal information that we collect and process is retained and stored in the United States and the European Union.

Your Choices

When you are enrolled in the Digital Companion, we offer the following choices that you can exercise with regard to your personal information.

Opt-out of the Digital Companion. You can opt-out of the Digital Companion at any time by following the prompts at the bottom of the navigation drawer on the home screen when you are in the Digital Companion. Opting out of the Digital Companion on Medisafe will not affect your participation in your underlying patient support program. To make changes to your participation in those programs, you can unsubscribe from any email sent by the program or by calling the program’s phone number (855-423-8725) or by calling LEO Pharma at (877) 494-4536.
Opt out of Medisafe or In-App Notifications. Please visit the Medisafe privacy policy at www.medisafe.com/privacy-policy to find more information on how to opt out of the full Medisafe app or to control in-app notifications.
Medisafe does not currently respond to web browser “do not track” signals or other mechanisms that provide a method to opt out of the collection of information across websites or other online services.
Email Marketing and Opt-Out Requests. You have the right to opt-out of receiving electronic direct marketing communications from us. All electronic direct marketing communications that you may receive from us, such as e-mail messages, will give you an “unsubscribe” option of not receiving such communications from us in the future.

Children’s Information

The Digital Companion is not intended for or directed to individuals under the age of eighteen (18). If a parent or guardian becomes aware that his or her child has directly provided us with personal information, please contact us by using the contact information below.

Accessing and Updating Your Information

We encourage you to update the personal information you provide to us, to help us continue to provide information that best meets your needs. You may be able to update this information through the Digital Companion, or visit www.leo-pharma.us/contact write to us at LEO Pharma Inc., 7 Giralda Farms, Madison, New Jersey, 07940 ATTN: Patient Support Services or call us at (877) 494-4536.

Third-Party Services

The Digital Companion is hosted within the Medisafe mobile application, which is owned and operated by Medisafe Project Ltd., a third party. Your use of the Medisafe mobile application may be governed by the Medisafe privacy policy, which may establish information collection, use, or disclosure practices different from our own. We encourage you to review the Medisafe privacy policy. In addition, your use of devices, digital assistants or third-party platforms to engage with the Digital Companion is subject to the privacy policies and practices of those entities. We encourage you to review the privacy policies of those third parties.

Your California Privacy Rights

If you reside in California, you or your authorized agent may request that we take the following actions with regards to your personal information

The Right to Know/Access Rights

You have the right to request that we disclose certain information to you about our collection and use of your personal information over the past 12 months. Once we receive and confirm your verifiable consumer request, we will disclose to you:

The categories of personal information we collected about you.
The categories of sources for the personal information we collected about you.
Our business or commercial purpose for collecting or selling that personal information.
The categories of third parties with whom we share that personal information.
The specific pieces of personal information we collected about you (also called a data portability request).

We do not sell or disclose your personal information for a business purpose.

Deletion Request Rights

You also have the right to request that we delete any of your personal information that we collected from you and retained, subject to certain exceptions. Once we receive and confirm your verifiable consumer request, we will delete (and direct our service providers to delete) your personal information from our records, unless an exception applies.

We may require additional information to verify and process your request. Applicable law may require or permit us to decline your request. If we decline your request, we will inform you of such decision, subject to legal restrictions.

Exercising Access, Data Portability, and Deletion Rights

To exercise your rights afforded under the California Consumer Privacy Act, please submit a verifiable consumer request to us by:

Emailing us at us.privacy@leo-pharma.com.
Using our web form. www.leo-pharma.us/contact
Writing to us at LEO Pharma Inc., 7 Giralda Farms, Madison, New Jersey, 07940 attention Patient Support Services
Calling us at (877) 494-4536.

Only you, or a person registered with the California Secretary of State that you authorize to act on your behalf, may make a verifiable consumer request related to your personal information. You may also make a verifiable consumer request on behalf of your minor child.

You may only make a verifiable consumer request for access or data portability twice within a 12-month period. The verifiable consumer request must:

Provide sufficient information that allows us to reasonably verify you are the person about whom we collected personal information or an authorized representative.
Describe your request with sufficient detail that allows us to properly understand, evaluate, and respond to it. We cannot respond to your request or provide you with personal information if we cannot verify your identity or authority to make the request and confirm the personal information relates to you.

Making a verifiable consumer request does not require you to create an account with us. We will only use personal information provided in a verifiable consumer request to verify the requestor’s identity or authority to make the request.

California Non-Discrimination Disclosure

We will not discriminate against you for exercising any of your California privacy rights under the California Consumer Privacy Act. For example, if you exercise your California privacy rights, we may not:

Deny you goods or services.
Charge you different prices or rates for goods or services, including through granting discounts or other benefits, or imposing penalties.
Provide you a different level or quality of goods or services.
Suggest that you may receive a different price or rate for goods or services or a different level or quality of goods or services.

Third Party Disclosures for Direct Marketing.

We do not disclose personal information to any third parties for their direct marketing purposes.

Do Not Track Requests

Under California law, website operators are required to disclose how they respond to web browser 'do not track' signals or other similar mechanisms that provide consumers with the ability to exercise choice regarding the collection of personal information of a consumer over time and across third-party websites, to the extent the operator engages in that collection. We do not respond to any such 'do not track' signals.

Nevada Privacy Rights.

Although we do not currently conduct sales of personal information, Nevada residents may submit a request directing us to not sell personal information we maintain about them to third parties who will sell or license their information to others.

Changes to This Privacy Policy

This Privacy Policy became effective on. We may update it from time to time. You are advised to consult the Privacy Policy regularly for any changes. If we make a material change to the Privacy Policy, we will take reasonable steps to notify you as may be required by law prior to putting the changes into effect.

How to Contact Us

If you have any questions, please visit www.leo-pharma.us/contact write to us at LEO Pharma Inc., 7 Giralda Farms, Madison, New Jersey, 07940 ATTN: Patient Support Services or call us at (877) 494-4536.

SMS Terms of Use

By registering for the Adbry® Advocate™ Program, you are agreeing to receive an opt-in SMS message from Adbry Alerts. Opt-in to Adbry Alerts to receive patient support SMS messages by replying "ADBRY". You will then receive a message confirming your enrollment. Message and data rates may apply. Message frequency may vary.
You can opt out of Adbry Alerts at any time by replying "STOP". You will receive a message confirming that you have unsubscribed from Adbry Alerts and will no longer be sent marketing messages about Adbry from LEO Pharma Inc.
You can reply "HELP" at any time to receive additional information about Adbry Alerts. You can also call 844-MY-ADBRY (844-692-3279) & visit Adbry.com.
T-Mobile is not liable for delayed or undelivered messages.
LEO Pharma Inc. will not be liable for any delayed or undelivered SMS messages.
Consent to receive marketing text messages about Adbry from LEO Pharma Inc. is not required as a condition of purchasing any goods or services. Texts may be sent using an automatic telephone dialing system.
Message and data rates may apply for any messages sent to you from LEO Pharma Inc. and to LEO Pharma Inc. from you throughout your participation in Adbry Advocate Alerts. If you have any questions about your text plan or data plan, please contact your wireless provider.
Support carriers include but are not limited to AT&T, Sprint/Boost/Virgin, T-Mobile/MetroPCS, Verizon Wireless.

IMPORTANT SAFETY INFORMATION AND INDICATION

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What should I discuss with my healthcare provider before starting ADBRY?

Tell your healthcare provider about all your medical conditions, including if you:

have eye problems.
have a parasitic (helminth) infection.
are scheduled to receive any vaccinations. You should not receive a “live vaccine” if you are treated with ADBRY.
are pregnant or plan to become pregnant. It is not known whether ADBRY will harm your unborn baby. There is a pregnancy exposure registry for women who use ADBRY during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. You or your healthcare provider can get information and enroll you in this registry by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/adbry-tralokinumab/.
are breastfeeding or plan to breastfeed. It is not known whether ADBRY passes into your breast milk and if it can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ADBRY?

See the detailed “Instructions for Use” that comes with ADBRY for information on how to prepare and inject ADBRY and how to properly store and throw away (dispose of) used ADBRY prefilled syringes and autoinjectors.
Use ADBRY exactly as prescribed by your healthcare provider.
Your healthcare provider will tell you how much ADBRY to inject and when to inject it.
ADBRY comes as a single-dose prefilled syringe with needle guard or as an autoinjector.
ADBRY is given as an injection under the skin (subcutaneous injection).
If your healthcare provider decides that you or a caregiver can give the injections of ADBRY, you or your caregiver should receive training on the right way to prepare and inject ADBRY. Do not try to inject ADBRY until you have been shown the right way by your healthcare provider. In children 12 years of age and older, it is recommended that ADBRY be given by or under supervision of an adult.
If you miss a dose, inject the missed dose as soon as possible, then continue with your next dose at your regular scheduled time.
If you inject too much ADBRY than prescribed, call your healthcare provider or call Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
Your healthcare provider may prescribe other medicines to use with ADBRY. Use the other prescribed medicines exactly as your healthcare provider tells you to.

What are the possible side effects of ADBRY?

ADBRY can cause serious side effects, including:

Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms:
- breathing problems
- itching
- skin rash
- swelling of the face, mouth, and tongue
- fainting, dizziness, feeling lightheaded (low blood pressure)
- hives

Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.

The most common side effects of ADBRY include:

Upper respiratory tract infections
Eye and eyelid inflammation, including redness, swelling, and itching
Injection site reactions
High count of a certain white blood cell (eosinophilia)

These are not all the possible side effects of ADBRY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is ADBRY?

ADBRY® (tralokinumab-ldrm) injection is a prescription medicine used to treat people 12 years of age and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. ADBRY can be used with or without topical corticosteroids.
It is not known if ADBRY is safe and effective in children under 12 years of age.

Do not use ADBRY if you are allergic to tralokinumab or to any of its ingredients.

Please see full Prescribing Information, including Patient Information and Instructions for Use.