Dossier Studies definition

Dossier Studies means, with respect to a given Product Candidate, those Clinical Trials (and including any related non-clinical or clinical studies) that are required by a Regulatory Authority to support and obtain Regulatory Approval for such Licensed Product for a given Indication in a Major Country.
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Examples of Dossier Studies in a sentence

  • Following GSK’s exercise of its Product Option, but not later than twelve (12) months prior to the first expected NDA filing for such Product Candidate targeting ▇▇▇▇, ▇▇▇ shall provide to ChemoCentryx a detailed development plan and associated budget for the conduct of the Dossier Studies for such Licensed Product targeting CCR9 (the “Development Plan and Budget”).

  • ChemoCentryx shall have the right to review and comment upon such Development Plan and Budget, and shall have the option (the “Co-Development Option”) within ninety (90) days following receipt of the final Development Plan and Budget to co-fund Dossier Studies for either (i) the Regulatory Approval of Crohn’s Disease only (the “CD Development Option”); or (ii) the Regulatory Approval of Crohn’s Disease as well as ulcerative colitis (the “CD/UC Development Option”).

  • Upon exercise of the Co-Development Option, ChemoCentryx shall pay to GSK a one time cash payment equal to [***] percent ([***]%) of the GSK Incurred Costs for either the Crohn’s Disease Dossier Studies, or the Crohn’s Disease and Ulcerative Colitis Dossier Studies, depending on whether ChemoCentryx exercised the CD Development Option or the CD/UC Development Option.

  • Such Development Plan and Budget shall govern all development activities of GSK (and its Affiliates) with respect to the Dossier Studies covered by such plan (and associated budget) on the applicable Co-Developed Product.

  • GSK shall use its Diligent Efforts to conduct such Dossier Studies on the Co-Developed Product in a timely *** Certain information on this page has been omitted and filed separately with the Commission.

  • Upon exercise of the Co-Development Option, ChemoCentryx shall pay to GSK a one time cash payment equal to thirty-five percent (35%) of the GSK Incurred Costs for either the Crohn’s Disease Dossier Studies, or the Crohn’s Disease and Ulcerative Colitis Dossier Studies, depending on whether ChemoCentryx exercised the CD Development Option or the CD/UC Development Option.

  • GSK shall use its Diligent Efforts to conduct such Dossier Studies on the Co-Developed Product in a timely fashion in accordance with the schedule and budget in such Development Plan and Budget and to seek Regulatory Approval of such Co-Developed Product as soon as practicable.