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.

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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.
The Manufacturing Lead shall have sole responsibility for preparing the draft of the [*] Marketing Application Core Dossier for the United States (the “CMC Core Dossier”).
In such event, the Parties shall share equally all costs associated with any preclinical studies required for the filing of an IND in both the Biosearch Territory and the Versicor Territory, as well as all costs associated with the conduct of all human clinical trials needed to compile the Core Dossier.

More Definitions of Core Dossier

Core Dossier has the meaning set forth in Section 5.2 (Core Dossier) of this Agreement.

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

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. Study” 13

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

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.