Common use of Manufacturing Limitations Clause in Contracts

Manufacturing Limitations. Under the Transfer Agreement, Immunocore shall be responsible (at its cost) for manufacturing the Terminated Product for clinical use and commercial sale; provided, to the extent GNE provides to Immunocore a cell-line proprietary to GNE for the manufacture of the Terminated Product, that manufacture of the Terminated Product [***] by a Third Party contract manufacturing organization [***] (the “Authorized CMO”). Alternatively, upon Immunocore’s written request, GNE shall [***]. GNE shall facilitate the transfer of any technology required to manufacture the Terminated Product to any such Authorized CMO in order to enable such Authorized CMO to manufacture Terminated Product on behalf of Immunocore. Immunocore shall enter into a manufacturing supply agreement with the Authorized CMO and shall be responsible for all costs and other obligations related to the manufacture and supply of the Terminated Product by the Authorized CMO to Immunocore. If a Terminated Product is being manufactured (whether for clinical use or commercial scale) by GNE (and not by an Authorized CMO) at the time of such termination, the Parties shall also negotiate in good faith the terms and timelines under which GNE would continue to manufacture such Terminated Product until a manufacturing transfer to an Authorized CMO has been completed, and GNE will use commercially reasonable efforts to accommodate Immunocore’s supply demands. Immunocore will use commercially reasonable efforts to effect the manufacturing transfer to the Authorized CMO as quickly as possible.

Appears in 2 contracts

Samples: License and Collaboration Agreement (Immunocore LTD), License and Collaboration Agreement (Immunocore LTD)

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Manufacturing Limitations. Under the Transfer Agreement, Immunocore Xencor shall be responsible (at its cost) for manufacturing the Terminated Product for clinical use and commercial sale; provided, to the extent GNE provides to Immunocore a cell-line proprietary to GNE for the manufacture of the Terminated Producthowever, that manufacture of the Terminated Product [***] shall only be conducted by a Third Party contract development and manufacturing organization [***] approved in advance by Genentech, such approval not to be unreasonably withheld or delayed (the “Authorized CMOCDMO”); provided, that Authorized CDMOs shall include any manufacturing organization being used by Genentech to manufacture any Termination Product. Alternatively, upon ImmunocoreXencor’s written request, GNE Genentech shall [***]. GNE shall facilitate designate an Authorized CDMO to make the transfer of any technology required to manufacture the Terminated Product to any such Authorized CMO in order to enable such Authorized CMO to manufacture Terminated Product on behalf of ImmunocoreXencor. Immunocore Xencor shall enter into a manufacturing supply agreement with the Authorized CMO CDMO and shall be responsible for all costs and other obligations related to the manufacture and supply of the Terminated Product by the Authorized CMO CDMO to ImmunocoreXencor. If a Terminated Product is being manufactured (whether for clinical use or commercial scale) by GNE Genentech (and not by an Authorized a CMO) at the time of such termination, the Parties shall also negotiate in good faith the terms and timelines under which GNE Genentech would continue to manufacture such Terminated Product until a manufacturing transfer to an Authorized CMO CDMO has been completed, and GNE will use commercially reasonable efforts to accommodate ImmunocoreXencor’s supply demands; provided, that the Terminated Product shall be supplied by Genentech to Xencor at the Cost of Manufacture plus five percent (5%) cost for the first two years following the effective date of Termination and plus ten percent (10%) cost for the third year following the effective date of Termination and all years CONFIDENTIALEXECUTION COPY thereafter. Immunocore Each Party will use commercially reasonable efforts to effect the manufacturing transfer to the Authorized CMO CDMO as quickly as possible.

Appears in 1 contract

Samples: Collaboration and License Agreement (Xencor Inc)

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Manufacturing Limitations. Under the Transfer Agreement, Immunocore Xencor shall be responsible (at its cost) for manufacturing the Terminated Product for clinical use and commercial sale; provided, to the extent GNE provides to Immunocore a cell-line proprietary to GNE for the manufacture of the Terminated Producthowever, that manufacture of the Terminated Product [***] shall only be conducted by a Third Party contract development and manufacturing organization [***] approved in advance by Genentech, such approval not to be unreasonably withheld or delayed (the “Authorized CMOCDMO”); provided, that Authorized CDMOs shall include any manufacturing organization being used by Genentech to manufacture any Termination Product. Alternatively, upon ImmunocoreXxxxxx’s written request, GNE Genentech shall [***]. GNE shall facilitate designate an Authorized CDMO to make the transfer of any technology required to manufacture the Terminated Product to any such Authorized CMO in order to enable such Authorized CMO to manufacture Terminated Product on behalf of ImmunocoreXencor. Immunocore Xencor shall enter into a manufacturing supply agreement with the Authorized CMO CDMO and shall be responsible for all costs and other obligations related to the manufacture and supply of the Terminated Product by the Authorized CMO CDMO to ImmunocoreXencor. If a Terminated Product is being manufactured (whether for clinical use or commercial scale) by GNE Genentech (and not by an Authorized a CMO) at the time of such termination, the Parties shall also negotiate in good faith the terms and timelines under which GNE Genentech would continue to manufacture such Terminated Product until a manufacturing transfer to an Authorized CMO CDMO has been completed, and GNE will use commercially reasonable efforts to accommodate ImmunocoreXencor’s supply demands; provided, that the Terminated Product shall be supplied by Genentech to Xencor at the Cost of Manufacture plus [***] for the first [***] following the effective date of Termination and plus [***] for the [***] following the effective date of Termination and all years thereafter. Immunocore Each Party will use commercially reasonable efforts to effect the manufacturing transfer to the Authorized CMO CDMO as quickly as possible.

Appears in 1 contract

Samples: Collaboration and License Agreement (Xencor Inc)

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