definiens: shall mean with respect to Bulk Substance, the certificate signed by a qualified representativerelating to the batch of Bulk Substance certifying that the batch of Bulk Substance meets the Specifications, and with respectto Filled Drug Product, the certificate signed by a qualified representative relating to the batch of Filled Drug Productcertifying that the batch of Filled Drug Product meets the Specifications . ”(i1 ) shall mean Bulk Substance that has undergone the additional manufacturing steps of formulationand filling, but not labelling and packaging other than as required for Delivery of unlabeled vials ( i.e. not labeled andpackaged for use in a clinical trial ) . Notwithstanding the foregoing, in respect of Lot # # ], Manufacturing shall, for the purposeof this Supply Agreement mean cGMP manufacturing of Filled Drug Product, i.e. which is inclusive of formulation and filling, but exclusive of labelling and final release for use in clinical trials . ”(g ) ( including cognates and ) means making Bulk Substance or Filled Drug Productavailable to KaloBios not cleared for export and not loaded onto any collecting vehicle ( Ex - Works Incoterms 2010 ) at thefacilities designated in Article 5 hereof . Risk of loss and title to Bulk Substance and Filled Drug Product passes to KaloBiosupon Delivery