Common use of Regulatory Transition Period Clause in Contracts

Regulatory Transition Period. In the event that Licensee or its Sublicensees cannot assign to XENCOR or the XENCOR Transferee any Regulatory Submissions or Regulatory Approvals related to the Licensed Asset or the Products in the Field in the Licensed Territory pursuant to Applicable Laws, or XENCOR reasonably requests that Licensee or its Sublicensee continue to hold any such Regulatory Submissions or Regulatory Approvals, then, during any period after the effective date of termination in which Licensee or a Sublicensee holds any Regulatory Submissions or Regulatory Approvals related to the Licensed Asset or Products in the Field in the Licensed Territory (the “Non-Transferred Regulatory Approvals”), Licensee shall take all lawful actions reasonably requested by XENCOR with respect to the Non-Transferred Regulatory Approvals and continue to perform its regulatory obligations under the Development Plan then in effect unless Licensee in good faith believes that such action may reasonably be likely to have a material detrimental effect on the health of study subjects. XENCOR shall reimburse Licensee for all costs incurred in connection with such actions.

Appears in 2 contracts

Samples: License Agreement (Zenas BioPharma, Inc.), License Agreement (Zenas BioPharma, Inc.)

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Regulatory Transition Period. In the event that Licensee or its Sublicensees cannot assign to XENCOR Zenas or the XENCOR Zenas Transferee any Regulatory Submissions Filings or Regulatory Approvals related to the Licensed Asset Compound or the Products in the Field in the Licensed Territory pursuant to Applicable Laws, or XENCOR Zenas reasonably requests that Licensee or its Sublicensee continue to hold any such Regulatory Submissions Filings or Regulatory Approvals, then, during any period after the effective date of termination in which Licensee or a Sublicensee holds any Regulatory Submissions Filings or Regulatory Approvals related to the Licensed Asset Compound or Products in the Field in the Licensed Territory (the “Non-Transferred Regulatory Approvals”), Licensee shall take all lawful actions reasonably requested by XENCOR Zenas with respect to the Non-Transferred Regulatory Approvals and continue to perform its regulatory obligations under the relevant Development Plan then in effect unless Licensee in good faith believes that such action may reasonably be likely to have a material detrimental effect on the health of study subjects. XENCOR Zenas shall reimburse Licensee for all costs incurred in connection with such actions.

Appears in 2 contracts

Samples: License Agreement (Zenas BioPharma, Inc.), License Agreement (Zenas BioPharma, Inc.)

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