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 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.
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.
Examples of Core Dossier in a sentence
The Parties shall reasonably cooperate in preparation of the Core Dossier and, as requested, country-specific Regulatory Filings for the Product, including providing information reasonably required and providing support for responding to regulatory questions related to such Party’s technology (e.g., Compound with respect to ProGen and Device with respect to Rani).
The messaging in the Core Dossier shall be consistent with the Platform Messaging.
More Definitions of Core Dossier
Core Dossier has the meaning set forth in Section 4.2 (Core Dossier). Portions of this exhibit have been omitted as the Registrant has determined that (i) the omitted information is not material and (ii) the omitted material is of the type that the Registrant treats as private or confidential. Omitted portions are indicated by [*]. Execution
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 [***].
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 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 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 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.