Clinical Trial Material definition

Clinical Trial Material or “CTM” means Licensed Product that is in a finished pharmaceutical dosage form that is (a) suitable for administration and dosing to humans in clinical trials, but (b) not intended for commercial sale (for example, without limitation, in a form that does not include external packaging and package inserts).
Clinical Trial Material means Product and placebo for administration to animals for pre-clinical testing or to humans for clinical testing.
Clinical Trial Material means Licensed Product and placebo for administration to humans in a Clinical Trial.

Examples of Clinical Trial Material in a sentence

  • Fresenius will notify TransMedics prior to the destruction of any PRODUCT designated as Clinical Trial Material involved in clinical trials in which TransMedics was engaged.

  • Promptly following either Party’s request, the Parties shall negotiate in good faith and enter into an appropriately detailed supply and quality agreement (the “Development Supply Agreement”) governing such supply of Clinical Trial Material by, or on behalf of, Xxxxxxx to Xxxxxxx with terms and conditions typical for such agreements and consistent with the terms set forth in this Agreement.

  • Review deviations, change controls and annotations associated with the manufacture of Clinical Trial Material and assess the impact as required.

  • If Xxxxxxx has elected to opt out of further joint Development of the Licensed Products pursuant to Section 3.10(g)(iii), the price of Clinical Trial Material Manufactured by or on behalf of Xxxxxxx and supplied to Xxxxxxx shall be [*] of the Manufacturing Cost of Xxxxxxx or its Affiliate(s) and paid for by Xxxxxxx.

  • In short, Patheon is uniquely capable of developing exactly the right formulation and processes to ensure a product’s future success.Late Development Services• Manufacturing Process Development• Analytical Method Development and Validation• Product Release and Stability Testing• Clinical Trial Material Manufacturing• Primary Packaging• Regulatory Dossier Support• Lifecycle Management Services Commercial Manufacturing A reputation for high quality established over 39 years.Dependable quality.


More Definitions of Clinical Trial Material

Clinical Trial Material means any raw materials, parts, or supplies used in the ordinary course of development of a Product for which regulatory approval has not yet been obtained and that are used exclusively for purposes of supporting clinical and preclinical research.
Clinical Trial Material means labeled and packaged Sphingosomal Vincristine, Sphingosomal Vinorelbine and/or Sphingosomal Topotecan, and any component(s) thereof used or to be used, in clinical trials.
Clinical Trial Material means the Licensed Compound in finished dosage form that is used in clinical trials, but not for Commercial sale.
Clinical Trial Material means Product and placebo for administration to humans in the BDSI Trials, Existing Clinical Trials, or Supportive Trials.
Clinical Trial Material means a Licensed Product or placebo, as applicable, that is in a finished pharmaceutical dosage form that is (a) suitable for administration and dosing to humans in clinical trials, but (b) not intended for commercial sale (for example, in a form that does not include external packaging and package inserts).
Clinical Trial Material means labeled and packaged Sphingosomal Vincristine, Sphingosomal Vinorelbine and/or Sphingosomal Topotecan, and any component(s) thereof, used or to be used, in clinical trials.
Clinical Trial Material means the Product manufactured by SurModics to support Clinical Trials.