Technical Dossier definition
Technical Dossier means a technical dossier outlining […***…].
Technical Dossier means a document providing such information as detailed in Schedule VII and to be submitted under Rule 10(1);
Technical Dossier means a document providing such information as detailed in Schedule IV and to be submitted under Rule 11(1).
Examples of Technical Dossier in a sentence
For clarity, the content of the Technical Dossier is limited to that described on Exhibit 1.54.
Subject to the terms and conditions of this Agreement, including but not limited to payment of the amounts set forth in Exhibit B hereto, EGB shall, during the Term, provide GTTX with full and unfettered access to the Technical Dossier.
Costs for preparing and updating the Technical Dossier including preparatory work like literature search, assessment of available data and writing (robust) study summaries.
It has legal title to, and sole beneficial interest in, the Technical Dossier and the Licensed Rights being licensed by GTTX hereunder, with full power, capacity and right to license them to GTTX.
More Definitions of Technical Dossier
Technical Dossier means, in respect of a particular Product, the document or documents that detail the chemical, manufacturing and controls information applicable to such Product and its Manufacture, including as set forth in any applicable Regulatory Approval for such Product.
Technical Dossier means all information relating to the Asset and the Licensed Rights which shall be inclusive of but not limited to the (i) composition; (ii) quality control standards and specifications; (iii) formulation results; (iv) methods of analysis of the raw materials and finished products; (v) stability data; (vi) research and development data; and (viii) any historical study, research and/or test results, which are in the possession or control of EGB.
Technical Dossier means a manual with all documentation mentioned in section 13;