Common use of Production of Industrial Scale Batches Clause in Contracts

Production of Industrial Scale Batches. Upon receipt by KRYPTON of GENTA JAGO's notice referred to in Section 7.1 above, the Parties shall initiate the production of three (3) industrial scale batches (hereinafter "Bio-Batches") on such equipment as shall eventually be used KRYPTON or a third party to commercially manufacture the Final Product, based on the Prototype Formulation (the size of each Bio-Batch to be not less than the greater of (i) 10% (ten percent) of the anticipated initial commercial batch size, or (ii) 100,000 tablets), according to Current Good Manufacturing Practices, such Bio-Batches to be subsequently used for stability testing and pivotal clinical studies; provided however, that GENTA JAGO shall have the ultimate responsibility with respect of any and all technical aspects of such production of batches related to the technology transfer and the implementation of such technology in the manufacturing site.

Production of Industrial Scale Batches. Upon receipt by KRYPTON of GENTA JAGO's notice referred to in Section 7.1 above, the Parties shall initiate the production of three (3) industrial scale batches (hereinafter "Bio-Batches") on such equipment as shall eventually be used KRYPTON or a third party to commercially manufacture the Final Product, based on the Prototype Formulation (the size of each Bio-Batch to be not less than the greater of (i) 10% (ten percent) of the anticipated initial commercial batch size, or (ii) 100,000 100'000 tablets), according to Current Good Manufacturing Practices, such Bio-Batches to be subsequently used for stability testing and pivotal clinical studies; provided however, that GENTA JAGO shall have the ultimate responsibility with respect of any and all technical aspects of such production of batches related to the technology transfer and the implementation of such technology in the manufacturing site.