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.
Regulatory Materials. The Transition Agreement will require the Opt-Out Party to transfer and assignwill grant to the Continuing Party a right of reference under all Regulatory Materials and Regulatory Approvals solely relating to thefor such Reversion Product that are owned or controlledControlled 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 ACTRUnum or SGI, respectively). The, unless and until assigned to the Continuing Party pursuant to any Transition Agreement will contain terms governing the coordination or transition of the Parties ongoing regulatory responsibilities with respect to such Reversion Product. Agreement.
Regulatory Materials. The Transition Agreement will require the Opt-Out Party or its Affiliate to transferenter into a supply and assignquality agreement to supply or have supplied the applicable SGI Antibody or ACTR T-cells (as the case may be) in the Reversion Product to the Continuing Party all Regulatory Materials and Regulatory Approvals solely relatinguntil such time as the Continuing Party provides written notice to the Reversion Product that are owned or controlled by the Opt-Out Party orof its Affiliates (other than Regulatory Materialsdecision, in its sole discretion, to cease permanently the Research, Development, and Regulatory Approvals for the ManufactureCommercialization 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. The cost to the Continuing Party for such supply will be the Manufacturing Costs plus a markup for the applicable SGI Antibody or ACTR T-cells (as the case may be) in the Reversion Product.
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