Compassionate Use Program means a reduction in Product costs below the Supply Price granted by KYE for a specified time to patients should such patients not have drug insurance or they cannot otherwise afford the Product after KYE receives a notice of compliance from Health Canada to market the Product in the Territory. For the purposes of this Subsection “Additional Bridging Program” means a reduction in Product costs below the Supply Price granted by KYE for a limited time to patients should there be a delay in such patients’ drug insurance coverage for the Product after all Participants in Studies have been bridged per Section 2.6. KYE and Catalyst agree to equally share in the costs of the Products for any such Additional Bridging Program and Compassionate Use Program in the Territory; provided however, that Catalyst’s obligation to share in the Product costs of such Compassionate Use Program shall only apply to patients prescribed the Product for on-label indications based on Health Canada’s product monograph. At all times during the Term, KYE shall be responsible for all requirements, operational costs and oversight of any such Compassionate Use Program. For clarity at the program’s commencement, patients who do not have drug insurance shall not be eligible for the Bridging Program and may only be considered for eligibility in the Compassionate Use Program. Prior to any subsequent changes in eligibility criteria in the Compassionate Use Program, KYE will consult with Catalyst to reach agreement between the Parties on such changes.
Compassionate Use Program means a compassionate use, patient name or similar program for supplying Special Products to certain patients.
Compassionate Use Program means a compassionate use, patient name or similar program for supplying Special Products to certain
Examples of Compassionate Use Program in a sentence
Prior to any subsequent changes in eligibility criteria in the Compassionate Use Program, KYE will consult with Catalyst to reach agreement between the Parties on such changes.
At all times during the Term, KYE shall be responsible for all requirements, operational costs and oversight of any such Compassionate Use Program.
For clarity at the program’s commencement, patients who do not have drug insurance shall not be eligible for the Bridging Program and may only be considered for eligibility in the Compassionate Use Program.
More Definitions of Compassionate Use Program
Compassionate Use Program means the use of a Licensed Product or a Licensed Service as an investigational drug in accordance with applicable law outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options.
Compassionate Use Program means a program according to which a medicinal product not authorized in Turkey – whether or not approved in other countries – is provided without charge by the originator/supplier in accordance with the guidelines and procedures described in the Guideline for Compassionate Use Program to a group of patients with a life-threatening disease or a condition that is severely disruptive of the quality of life, who cannot be enrolled in relevant clinical trials in the subject matter and in whom treatment using medicinal products already authorized/permitted by the Ministry of Health or standard therapeutic methods have failed or it is no longer possible to use these treatments;