definiens: means the Protocol~, including the Standard Operating Procedure ( SOP ) numbered : 01 - C-0215A, entitled " A Phase I Study of Hepatic Arterial Infusion of Escalating Dose Melphalan with Venous Filtration for Unresectable Cancers of the Liver " ; 04 - C-0273 entitled IIA Phase II Study of Hepatic Arterial Infusion of Melphalan With Venous Filtration Via Peripheral Hepatic Perfusion ( PHP ) for Unresectable Primarv and Metastatic Cancers of the LiverA Random - Assignment Study of Hepatic Arterial Infusion of Melphalan with Venous Filtration via Peripheral Hepatic Perfusion ( PHP ) ( Delcath System ) Versus Best Alternative Care for Ocular and Cutaneous Melanoma Metastatic to the Liverll ' IJhich is attached hereto as Appendix 0 and is made a part of this /\greement