Safety Databases definition

Safety Databases means the global safety databases related to the Regulatory Filings.
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Examples of Safety Databases in a sentence

  • From and after the License Commencement Date, OST (or its designee) shall file and hold title to all Regulatory Filings relating to the Licensed Products in the Field, provided, however, that Advaxis shall have the right to reference any nonclinical, CMC and safety data (including Safety Databases) or other Regulatory Filings or Regulatory Approvals of OST relating to the Licensed Products in any Regulatory Filings made by or on behalf of Advaxis outside of the Field.

  • From and after the License Commencement Date, as between the parties, OST shall be responsible for preparing, filing and maintaining, and shall have the exclusive right to reference, any and all Regulatory Filings, Safety Databases, and related submissions with respect to the Licensed Products in the Field.

  • At all times prior to the POC Date, Advaxis shall retain responsibility for maintaining the Safety Databases, developmental core safety information (“DCSI”), and core data sheet (if any).

  • As promptly as practicable, but no later than ninety (90) days, after the POC Date, or as otherwise agreed by the parties, Advaxis shall transfer and assign to Amgen any Regulatory Filings controlled by Advaxis for the Products and the Safety Databases (such date of transfer and assignment, the “Regulatory Filing Transfer Date”).

Related to Safety Databases

  • Data means recorded information, regardless of form, the media on which it is recorded, or the method of recording.

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;