Regulatory Filings and Safety Databases Sample Clauses

Regulatory Filings and Safety Databases. As promptly as practicable, Advaxis will transfer to OST any Regulatory Filings controlled by Advaxis for the Licensed Products in the Field. 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.
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Related to Regulatory Filings and Safety Databases

  • Regulatory Filings NYISO and Connecting Transmission Owner shall file this Agreement (and any amendment hereto) with the appropriate Governmental Authority, if required. Any information related to studies for interconnection asserted by Developer to contain Confidential Information shall be treated in accordance with Article 22 of this Agreement and Attachment F to the ISO OATT. If the Developer has executed this Agreement, or any amendment thereto, the Developer shall reasonably cooperate with NYISO and Connecting Transmission Owner with respect to such filing and to provide any information reasonably requested by NYISO and Connecting Transmission Owner needed to comply with Applicable Laws and Regulations.

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