Development and Scale-Up Clause Samples
Development and Scale-Up. Auxilium shall, at its own cost and expense, utilizing the Back-Up Supplier (defined below), develop the formulation and the finished dosage form and scale up the Manufacture for clinical supply of the Enzyme and the Product for each Indication for use in the Field, including the [**], to be registered with Regulatory Authorities in accordance with Law and in sufficient time prior to anticipated commercial launch of a Product to provide for sufficient Supply of Product for use in the Field. Auxilium will have the sole right and responsibility for selecting the finished dosage form and presentation for the Product in the Field. The costs paid to third parties to develop the lyophilization of the injection formulation shall be shared equally by the Parties. [**].
Development and Scale-Up. BTC shall, at its own cost and expense, develop the formulation and the finished dosage form and scale-up the Manufacture for commercial supply of the Enzyme and the Product for each Indication for use in the Field, including the [**], to be registered with Regulatory Authorities in accordance with Law and in sufficient time prior to anticipated commercial launch of a Product to provide for sufficient supply of Product for use in the Field. Notwithstanding the foregoing, Auxilium will have the sole right and responsibility for selecting the finished dosage form and presentation for the Product in the Field.