Common use of Transfer of U Clause in Contracts

Transfer of U. S. BLA for In-Vivo [***] Products. 7.6.1 U.S. BLA for In-Vivo [***] Products. In advance of the anticipated date of receipt of Regulatory Approval for an In-Vivo [***] Product from the FDA in the U.S., the Parties’ regulatory teams will meet and agree on process for timely transferring over the BLA for the U.S. [***] Product following receipt of such BLA from FDA along with the necessary dossier for such Product to allow for the prompt Commercialization of such U.S. [***] Product. As soon as reasonably practicable following the date of receipt of Regulatory Approval for an In-Vivo [***] Product from the FDA in the U.S. and in accordance with the mutually agreed timetable for such transfer, which, in any event will be no later than [***] days following the date of receipt of Regulatory Approval for such In-Vivo [***] Product from the FDA in the U.S., NVS will submit a letter or other document informing the FDA that all rights to the BLA filed for such In-Vivo [***] Product have been transferred to HMI (the date of such transfer of the BLA, the “U.S. BLA Transfer Date”). NVS will transfer to HMI copies (in electronic or other format) of such BLA and any other Regulatory Submissions owned or Controlled by NVS or its Affiliates as of the U.S. BLA Transfer Date to the extent not already in HMI’s or its Affiliates possession that are exclusively related to In-Vivo [***] Products in the U.S., excluding any such data relating to any Other Components (the “Assigned Regulatory Submissions”) in accordance with the timeline mutually agreed upon by the Parties.

Transfer of U. S. BLA for In-Vivo [***] SCD Products. 7.6.1 U.S. BLA for In-Vivo [***] SCD Products. In advance of the anticipated date of receipt of Regulatory Approval for an In-Vivo [***] SCD Product from the FDA in the U.S., the Parties’ regulatory teams will meet and agree on process for timely transferring over the BLA for the U.S. [***] SCD Product following receipt of such BLA from FDA along with the necessary dossier for such Product to allow for the prompt Commercialization of such U.S. [***] SCD Product. As soon as reasonably practicable following the date of receipt of Regulatory Approval for an In-Vivo [***] SCD Product from the FDA in the U.S. and in accordance with the mutually agreed timetable for such transfer, which, in any event will be no later than [***] days following the date of receipt of Regulatory Approval for such In-Vivo [***] SCD Product from the FDA in the U.S., NVS will submit a letter or other document informing the FDA that all rights to the BLA filed for such In-Vivo [***] SCD Product have been transferred to HMI (the date of such transfer of the BLA, the “U.S. BLA Transfer Date”). NVS will transfer to HMI copies (in electronic or other format) of such BLA and any other Regulatory Submissions owned or Controlled by NVS or its Affiliates as of the U.S. BLA Transfer Date to the extent not already in HMI’s or its Affiliates possession that are exclusively related to In-Vivo [***] SCD Products in the U.S., excluding any such data relating to any Other Components (the “Assigned Regulatory Submissions”) in accordance with the timeline mutually agreed upon by the Parties.