Clinical Trial Material Sample Clauses
The Clinical Trial Material clause defines the terms and conditions governing the supply, use, and management of materials provided for use in a clinical trial, such as investigational drugs, placebos, or devices. It typically outlines responsibilities for manufacturing, quality control, delivery, storage, and handling of these materials, and may specify requirements for labeling, tracking, and return or destruction after the trial concludes. This clause ensures that all parties understand their obligations regarding the safe and compliant management of clinical trial materials, thereby safeguarding participant safety and regulatory compliance.
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Clinical Trial Material. AltaRex shall provide UP free of charge with all bulk drug substance, clinical trial material and other forms and formulations of OvaRex® and other compounds and products within the Licensed Technology in AltaRex’s possession or control as of the Effective Date as UP shall reasonably request in connection with the performance of its obligations during the Initial Assessment Period and the UP Development Program and otherwise in accordance with this Agreement.
Clinical Trial Material. VERTEX will conduct its clinical studies with clinical trial material the manufacture of which is designed to conform, as and to the extent required by applicable U.S. federal regulations or as directed by the JRC, to GMP standards. As soon as practicable after the exercise of its Development Election with respect to a Drug Product Candidate, VERTEX will deliver to NOVARTIS, and NOVARTIS will accept, all clinical trial material for that Candidate in its possession to the extent it is usable in connection with further development of that Candidate. NOVARTIS will reimburse VERTEX for the Manufacturing Cost of that material within thirty (30) days of receipt of VERTEX's invoice therefor.
Clinical Trial Material. If Pendopharm determines that clinical studies shall be performed in the Territory, Edesa will supply the required clinical supply of the Licensed Products to Pendopharm at actual cost. Detailed supply terms and responsibilities of the Parties regarding quality will be agreed in a separate supply agreement prior to the commencement of the supply of Licensed Products to Pendopharm, with the proviso that such additional terms must reasonably enable Edesa to meet the terms agreed with Edesa's contract manufacturer.