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Regulatory Materials
Regulatory Materials contract clause examples

Regulatory Materials. The Opt-Out Party will grant to the Continuing Party a right of reference under all Regulatory Materials and Regulatory Approvals for such Reversion Product that are Controlled by the Opt-Out Party or its Affiliates (other than Regulatory Materials and Regulatory Approvals for the Manufacture of the ACTR T-cells or the SGI Antibodies, as applicable, which will be retained by Unum or SGI, respectively), unless and until assigned to the Continuing Party pursuant to any Transition Agreement.

Regulatory Materials. The Transition Agreement will require the Opt-Out Party to transfer and assign to the Continuing Party all Regulatory Materials and Regulatory Approvals solely relating to the Reversion Product that are owned or controlled by the Opt-Out Party or its Affiliates (other than Regulatory Materials and Regulatory Approvals for the Manufacture of the ACTR T-cells or the SGI Antibodies, as applicable, which will be retained by ACTR or SGI, respectively). The Transition Agreement will contain terms governing the coordination or transition of the Parties’ ongoing regulatory responsibilities with respect to such Reversion Product.

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