Compassionate Use Program definition

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.
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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.
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Compassionate Use Program means a compassionate use, patient name or similar program for supplying Special Products to certain
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Examples of Compassionate Use Program in a sentence

  • Unimed shall continue to fulfill this obligation regardless of whether the NDA Supplement is approved for so long as tablets are available; provided, however, that once tablets are available for commercial sale, Unimed may cease distribution under the Compassionate Use Program.

  • New patients may be included in Compassionate Use Program (CUP) / Compassionate Use Named Patient (CUNP) [x] months from the Framework Agreement entry into force.

  • 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.

  • In the event that Lilly pursues a Compassionate Use Program as described in 21 CFR Sections 312.34, 312.35 and 312.37 for treatment of patients for emergency use, or for related use on a compassionate use basis (the "Compassionate Use Program") for a particular Drug Product, Lilly and Vertex hereby agree to share all reasonable direct costs associated with such Compassionate Program as follows: [*].

  • Reporting of spontaneously reported adverse drug reactions As indicated in FAMHP guidelines, normal pharmacovigilance requirements apply in a Medical Need or Compassionate Use Program.

  • At all times during the Term, KYE shall be responsible for all requirements, operational costs and oversight of any such Compassionate Use Program.

  • The Buyer expects from a commercial perspective to have to satisfy all the Seller’s French Revenue Liabilities to enable the Buyer to continue French Early Access Compassionate Use Program.

  • ILEX Know-How to be transferred shall include the Oxypurinol IND and Orphan Drug Designation, all technical information relating to Compound which is held by ILEX including information on Compound manufacturing and Product formulation and all pre-clinical and clinical information including information relating to the Compassionate Use Program, except for the ILEX Clinical Trial Data Package.

  • 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.

  • Indoor Harvest has developed patent pending cannabis cultivation technology to be used in the Joint Venture to develop specific intellectual property and research into the development of specific chemical expression profiles and will provide Design-Build services to Alamo CBD in the construction of its cannabis oil production facility under the Texas Compassionate Use Program.


More Definitions of Compassionate Use Program

Compassionate Use Program means a compassionate use, patient name or similar program for supplying Special Products to certain patients.
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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;
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Related to Compassionate Use Program

  • Direction-indicator lamp means the lamp used to indicate to other road-users that the driver intends to change direction to the right or to the left;

  • Approved abuse education training program means a training program using a curriculum approved by the abuse education review panel of the department of public health or a training program offered by a hospital, a professional organization for physicians, or the department of human services, the department of education, an area education agency, a school district, the Iowa law enforcement academy, an Iowa college or university, or a similar state agency.

  • Child care program means a person or business that offers child care.

  • E-Verify Program above means the employment verification program administered by the United States Department of Homeland Security, the Social Security Administration, or any successor program.

  • Managed Care Program means the process that determines Medical Necessity and directs care to the most appropriate setting to provide quality care in a cost-effective manner, including Prior Authorization of certain services.