Pre-filled Syringe Sample Clauses

Pre-filled Syringe. In accordance with Section 4.9.3, the Parties agree that pre-filled syringe Licensed Products (the “Pre-filled Syringe”) will be Developed for obtaining Marketing Approval in the U.S. and the European Core Territory. KHK shall be responsible for performing (i) CMC activities including manufacturing, stability, tech transfer and lab study, and (ii) clinical and regulatory activities necessary to obtain the regulatory approval for the Pre-filled Syringe in the European Core Territory, in accordance with the attached Exhibit A. [***] shall bear the costs in connection with such activities including [***]. Up and until the Profit Share Transition Date, UGNX shall be responsible for performing certain clinical and regulatory activities necessary to obtain the Marketing Approval for the Pre-filled Syringe in the U.S., including the Human Factor Engineering (HFE) study, in accordance with the attached Exhibit A (the “UGNX Activities”). For the avoidance of doubt, the Parties acknowledge and agree that the UGNX Activities as of the Amendment Effective Date do not include any clinical bridging study. In the case a clinical bridging study is required in the US, the Parties shall discuss in good faith with regards to the responsibilities and cost allocations for such study. UGNX shall bear the same responsibilities and obligations to the UGNX Activities as UGNX bears in Articles 4 and 5 of the Collaboration Agreement. UGNX and KHK shall [***] the costs in connection with the UGNX Activities including [***]. The timeline of the Pre-filled Syringe Development in the U.S. (the “Timeline”) is attached hereto as Exhibit B. In the event any of the UGNX Activities need to continue beyond the Profit Share Transition Date, the Parties shall separately discuss and agree upon development and cost-sharing of such continued activities.
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Related to Pre-filled Syringe

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