Transferred Regulatory Filings definition
Examples of Transferred Regulatory Filings in a sentence
Novavax and Sanofi shall cooperate to prepare and deliver any letters or other documents required by any Regulatory Authority to effectuate the transfer of such Transferred Regulatory Filings from Novavax to Sanofi.
If, at any time after the Transferred Regulatory Filings are transferred to Pharming, a Regulatory Authority requests information, data, or documentation Controlled by Novartis or its Affiliates, Novartis will provide such information, data, or documentation, to the extent that such information, data and documentation is accessible by Novartis using Commercially Reasonable Efforts, and shall reasonably cooperate with Pharming with respect to responding to requests from Regulatory Authorities.
ADCT and its Affiliates and licensees will continue to have a right of reference to the Transferred Regulatory Filings under Section 2.14 (Right of Reference), and the Data included in the Transferred Regulatory Filings will remain ADCT Know-How.
There are no liens or other encumbrances on the BVI Technology, BVI Transferred Regulatory Filings, or any part of either of the foregoing which would interfere with the rights granted, or assignment of assets, to MPI hereunder.
Unless otherwise required by applicable Law, from and after the date of such assignment and transfer, Cardurion (or its designee) shall have the sole right, at its sole cost and expense, to file, maintain, and hold title to all Transferred Regulatory Filings.
To the Knowledge of Sellers, no event has occurred that, with or without notice or lapse of time or both, would reasonably be expected to result in the revocation, suspension or limitation of any of Transferred Regulatory Filings.
However, both Parties agree to work together to ensure a smooth transfer of Transferred Regulatory Filings and continuous dialog with FDA or foreign equivalent.
Akebia and its Affiliates and licensees will continue to have a right of reference to the Transferred Regulatory Filings under Section 5.4.2 (Rights Granted to Akebia), and the Know-How included in the Transferred Regulatory Filings will remain Akebia Know-How.
Without limiting Sections 2.3 through 2.6, the Parties shall use its Commercially Reasonable Efforts to ensure an orderly Know-How Transfer and transfer of the Transferred Regulatory Filings.
Promptly after the Closing, Seller and Purchaser shall execute and submit to the applicable Regulatory Authorities mutually agreed on letters to transfer the Transferred Regulatory Filings from Seller to Purchaser, and Seller and Purchaser shall cooperate to complete and file any other documentation required to transfer the Transferred Regulatory Filings to Purchaser.