Core Dossier definition

Core Dossier means the compilation of CMC, pre-clinical, clinical data provided by Nanobiotix to Lian necessary to support and maintain Regulatory Approvals in the Field in the Territory.

Core Dossier means a compilation of clinical Data, preclinical Data and other information necessary for filing an MAA in the United States and the Major EU Countries.

Core Dossier means the dossier of common human clinical trial data and regulatory information required for filing for regulatory approval in both the Biosearch Territory and the Versicor Territory.

Examples of Core Dossier in a sentence

• In addition, Lian shall provide to Nanobiotix an English translation of those selected Promotional Materials reasonably requested by Nanobiotix for its review and, as applicable, discussion with Lian; (c) all Promotional Materials shall be consistent with the Core Dossier for the Licensed Product; and (d) [***].

• As between the Parties and notwithstanding anything to the contrary provided in this Agreement, Nanobiotix shall retain the full unfettered ownership of the Core Dossier.

• Notwithstanding the foregoing, Amgen shall have no obligation to share with the non-Regulatory Lead the contents of the CMC Core Dossier.

• Based on such table of contents and strategic plan, Amgen shall prepare the draft of the CMC Core Dossier and provide such draft to Novartis for review and comment.

• The Development Budget included in the GDP shall be a rolling budget setting forth the budgeted amounts for Development Costs with respect to activities allocated to the Parties in support of the Core Dossier under the GDP.

More Definitions of Core Dossier

Core Dossier has the meaning set forth in Section 4.2 (Core Dossier). 1. 37.

Core Dossier means the Data intended for use in obtaining Regulatory Approval of the Collaboration Product in the U.S., including to the extent generated in countries other than the U.S. For clarity, Data included in the Core Dossier may be used in support of obtaining Regulatory Approval of a Collaboration Product outside of the U.S. and such use shall not alter the sharing of Development Costs to generate such Data set forth in Section 4.7.1 (e.g., the study to generate such Data shall not be considered a Country-Specific Development Activity).

Core Dossier. Study” 13

Core Dossier means the collection of Data and information necessary for obtaining from the FDA and EMA the Marketing Approvals for the Licensed Product for the first adult Indication and the first pediatric Indication in the U.S. and the EEA respectively.

Core Dossier means with respect to each Development Plan, those pre-clinical and clinical studies required in the United States for submission and approval of the NDA for a Licensed Product. It is anticipated that the studies comprising the Core Dossier would, in general, be those which are also required for approval in Europe.

Core Dossier means the Data intended for use in obtaining Regulatory Approval of a Licensed Product in the [***]. For clarity, Data included in the Core Dossier may be used in support of obtaining Regulatory Approval of a Licensed Product [***]. *** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.

Core Dossier means the single common core database described in ------------ Art. 4.1. which refers to the indications listed in Art. 5.2