Formulation and Filling Sample Clauses
Formulation and Filling. When requested by Kolltan with no less than [**] months’ notice, MedImmune will fill DS into unlabeled vials and package them for shipment for a fee of $[**] per batch. MedImmune will formulate UDS into DS for a fee of $[**] per batch. At Kolltan’s request, MedImmune may recommend a contract manufacturer for filling, labeling and/or formulation and establish a plan for the transfer of the UDS and DS and the information necessary and customary in the industry to enable a Third Party to formulate UDS and fill DS for Kolltan. Kolltan will pay for the cost of transfer to the contract manufacturer. Drug Product: Storage temperatures between [**] Shipment temperatures between [**] Unformulated Drug Substance: Storage temperature at [**] Master Cell Bank: Stored in the [**]. Storage temperature at less than [**] Product Name: MEDI3379 Unformulated Drug Substance (Process 1) Material Number: [**] Formulation: [**] Storage Temperature: [**] Storage Container: 16 L Celsius Bag Maximum Dose: [**] Body Mass: 40 – 150 kg Version: 1.0 Product Name: MEDI3379 Unformulated Drug Substance (Process 1) Material Number: [**] Formulation: [**] Storage Temperature: [**] Storage Container: 16 L Celsius Bag Maximum Dose: [**] Body Mass: 40 – 150 kg Version: 1.0 Endotoxin (LAL) QC-9744 [**] [**]. [**] [**] Lot Release [**] [**] 02 May 12 Analytical Biochemistry [**] [**] 3 May 12 Quality Assurance [**] [**] 04 May 12 Product Name: MEDI3379 Drug Product (Process 1) Formulation: [**] Storage Condition: [**] Material Number: [**] Maximum Dose: [**] Body Weight Range: 40 – 150 kg Nominal Fill Volume: 1.0 mL Fill Volume: 1.3 mL Comments: Not applicable
Formulation and Filling. The Supply Price shall include the out-of-pocket amounts actually paid by GENTA to its Subcontractors for FORMULATION AND FILLING resulting in BULK DRUG PRODUCT that is used to manufacture FINISHED PRODUCT supplied to AVENTIS hereunder. The Supply Price shall also include reasonable testing, freight, warehousing and insurance costs associated with FORMULATION AND FILLING and the shipment of BULK DRUG PRODUCT to the person or entity responsible for FINAL PACKAGING (if necessary), to the extent separately invoiced to GENTA and not otherwise already built into the amounts charged to GENTA by such Subcontractors.