Last update: August 27, 2015
The ICLUSIG Canadian Controlled Distribution Program website, accessible at www.iclusigcdp.ca (the “Website”) is owned and operated by Paladin Labs Inc., an operating company of Endo International plc (NASDAQ:ENDP)(TSX:ENL) (“Paladin”, “we”, “us”) and its content is intended to Canadian residents only. The Website and these terms shall be governed by the laws of Quebec and the applicable laws of Canada without reference to principles of conflict of laws. You agree to be bound by such laws.
Paladin reserves the right to update or otherwise modify this Agreement, as it deems to be necessary. When applicable, these modifications will be effective immediately and will be incorporated to this Agreement upon notice thereof, which may be provided by any reasonable mean, including by displaying a notice on the Website landing page or at the beginning of the updated Agreement. Your continued use of the Website following such notice will be deemed to constitute an acceptance of the updated Agreement.
The Agreement governs your use of the Website, including without limitation the use of all its content such as the Certification Program as defined below, text, information, and the integrated tools, software, databases, and other related elements.
II. ABOUT ICLUSIG
ICLUSIG has been approved in adult patients with chronic phase (CP), accelerated phase (AP), or blast phase (BP) chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom other tyrosine kinase inhibitor (TKI) therapy is inappropriate or where there is prior TKI resistance or intolerance.
Marketing authorization with conditions is based on response rate. There are no trials demonstrating increased survival or improvement in symptoms with ICLUSIG. In the pivotal trial, the majority of the hematological responses occurred within 1 month. Consider discontinuing ICLUSIG if a hematological response has not been achieved by 3 months (90 days).
ICLUSIG for this indication has been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit. Patients should be advised of the conditional nature of the authorization.
For a complete description of ICLUSIG, its indications, restrictions or conditions, please consult the product monograph.
III. ABOUT THE WEBSITE
The Website is part of the Controlled Distribution Program (the “CDP”) required by Health Canada to ensure that the benefit of the ICLUSIG drug (“ICLUSIG”) outweighs the risks of vascular occlusion and congestive heart failure that might arise from the taking of ICLUSIG.
The Website includes three sections: 1) for prescribers; 2) for pharmacists; and 3) for ICLUSIG patients.
To ensure that prescribers understand the risks associated with the use of ICLUSIG within the indicated patient population, the CDP, through the Website, is intended to educate them about ICLUSIG and offers prescribers a certification program (the “Certification Program”). Only prescribers who complete the Certification Program can prescribe ICLUSIG.
Prior to participating to the Certification Program, prescribers must carefully read the program related documentation, including the ICLUSIG Product Monograph, the ICLUSIG Medication Guide and the ICLUSIG Educational Slide Set. To obtain their certification, prescribers must pass the Knowledge Assessment at the end of the Slide Set with a score of 100% and complete the registration form.
The section for pharmacists is intended to inform and educate pharmacists about ICLUSIG.
Only pharmacies that have agreed via contract with Paladin or its designee to follow the CDP requirements (the “Authorized Pharmacists”) can dispense ICLUSIG. The Website also provides a section where the Authorized Pharmacists can check whether their patients’ prescribers are certified in the ICLUSIG Certified Prescriber Database (the “CDP Database”), as ICLUSIG can only be dispensed to patients whose prescribers have been certified through the Certification Program.
3. ICLUSIG Patients
This section of the Website is intended to educate prescribed patients about ICLUSIG and the serious risks associated with ICLUSIG. However, while the Website offers information about ICLUSIG, we do not offer through this Website personalized medical diagnosis or patient-specific treatment advice. The patients’ respective doctor or other healthcare professional, as a learned intermediary, are the ones who can provide medical advice and determine whether a product is indicated for their patients.
IV. MEDICAL INFORMATION
Nothing on this Website should be construed as the giving of advice or the making of a recommendation regarding any decision or action related to your health or the health of others. If you are a patient, you should consult a doctor or other qualified health care professional regarding any questions you have about your health or before making any treatment decisions. If you are a doctor or other qualified health care professional, you should not allow the content of this website to substitute for your own medical judgment, which you should exercise in evaluating the information on this website.
PATIENTS MUST CONSULT THEIR DOCTOR, OR OTHER QUALIFIED HEALTH CARE PROFESSIONAL, BEFORE USING ANY PRODUCT DISCUSSED WITHIN THIS WEBSITE OR IN ANY OTHER WEBSITE OWNED BY PALADIN.
V. ACCESS TO THE WEBSITE
Prescribers need a valid and current professional licence number and an email address to access this Website. Pharmacists need a valid and current professional licence number to access the Website. A security code will be provided by Paladin to Authorized Pharmacists only to access the CDP database.
VI. USE OF THE WEBSITE
The Website is intended to be used, depending on the section, by prescribers and pharmacists, for their respective professional use and ICLUSIG patients, for their personal use, except when otherwise authorized by Paladin. Under no circumstances may the Website be used in a manner that could infringe the rights of Paladin or a third party. You agree that your access and use of the Website comply with this Agreement and with all applicable laws and regulations. You undertake not to use the Website for malicious, illegal or illicit purposes.
VII. OWNERSHIP AND INTELLECTUAL PROPERTY RIGHTS
ARIAD Pharmaceuticals, Inc. (“ARIAD”) is the owner and manufacturer of ICLUSIG.
Material on this Website, including but not limited to text, images, illustrations, software, is owned or otherwise provided by Paladin, and Paladin does not represent or warrant that such material does not infringe the rights of any other person or entity.
Trademarks and logos displayed on this Website, whether they are registered or not, are the property of Paladin, ARIAD or of their respective owners, and may not be used without written permission from each respective owner. It is therefore forbidden to copy, modify, delete, publish, transmit, create derivative works of, display or post, or in any other way exploit or use such content without the express authorization of each respective owner.
However, you may use any information or material contained on this Website purposely made available by Paladin for downloading or copying, provided that you: