Batch Release. LEO shall ensure that each Product has been Manufactured in compliance with the requirements of the Registration and shall release only batches accompanied by a certificate of compliance signed by a qualified person of LEO that the Product has been Manufactured by LEO according to the Specifications and that LEO is committed to inform GALEN in the event of any change in the manufacturing process or in the analytical specification, in accordance with the terms of this Agreement, and of any noted incident occurring during the Manufacture of the Product. In preparing the certificate of compliance, qualified person of LEO shall take into account analytical results, essential information such as the production conditions, the results of in-process controls and the examination of manufacturing documents. LEO shall create and retain records relating to each batch of the Product Manufactured hereunder in accordance with applicable Law.
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Batch Release. LEO shall ensure that each Product has Produc▇ ▇as been Manufactured in compliance with the requirements of the Registration and shall release only batches accompanied by a certificate of compliance signed by a qualified person of LEO that the Product has been ▇▇en Manufactured by LEO according to the Specifications Specificatio▇▇ and that LEO is committed to inform info▇▇ GALEN in the event of any change in the ▇▇ ▇▇e manufacturing process or in the analytical specification, in accordance with the terms of this Agreement, and of any noted incident occurring during the Manufacture of the Product. In preparing the certificate of compliance, qualified person of LEO shall take into account analytical analy▇▇▇al results, essential information such as the production conditions, the results of in-process controls and the examination of manufacturing documents. LEO shall create and retain records recor▇▇ relating to each batch of the Product Manufactured hereunder in accordance with applicable Law.
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