definiens: means ( i ) the Clinical Quality Agreement(s ) with respect to Clinical API and Clinical Product, and ( ii ) the written agreements to be agreed upon by ( a ) MERCK and ARlAD with respect to MERCK 's Manufacture of Marketed Product and MERCK Product, ( other than with respect to Japan ), ( b ) MERCK and [COMPANY] and any Approved Manufacturer of Commercial API or rapamycin used to Manufacture Commercial API~ with respect to the Manufacture of rapamycin or Commercial API, and ( c ) MERCK, ARlAD and Banyu Phannaceutical Co a company organized and existing under the laws of Japan and having its principal office at Kitanomaru Square, 13 - 12, Kudankita 1 - chome, Chiyoda - ku, Tokyo, Japan and any Approved Manufacturer of Commercial API or rapamycin used to Manufacture Commercial API, with respect to the Manufacture of rapamycin, Commercial API, and MERCK Product ( with respect to Japan ), 1.57 . means the procedures ( i ) established by ARlAD or an Approved Manufacturer with respect to Clinical Product ( prior to Clinical Product Transfer ) and API to ensure that such Clinical Product and API, as the case may be, is Manufactured in compliance with the terms of this Agreement relating to the quality of such API or Clinical Product ( including conformity with Specified Regulatory Requirements ), any Materials, and applicable Specifications for Manufacture of Clinical Product and API and confonnity with the applicable Quality Agreement(s ), and ( ii ) established by MERCK or an Approved Manufacturer with respect to Clinical Product ( after Clinical Product Transfer ) and Marketed Product and MERCK Product to ensure that such Clinical Product, Marketed Product or MERCK Product, as the case may be, is Manufactured in compliance with the tenus of this Agreement relating to the quality of such PrOduct ( including conformity with Specified Regulatory Requirements ), any Materials, and confonnity with applicable Specifications for Manufacture of Clinical Product, Marketed Product and MERCK Product and the applicable 11 CONFIDENTIAL TREATMENT REQUESTED Rlo .. tri<;t\.d R ~ C < lnfiden11111 _ nell .... .