definiens: means Product that : ( i ) was not Manufactured, prepa red, handled and/or shipped in compliance with applicable cGxPs, Applic able Standards, the Quality Agreement, master batch records and/or any other procedures or docume nts agreed upon by the parties in writing ; ( ii ) does not conform to the Specifications or any other Product related warranties or representations set out in this Agreement ; ( iii ) has less than the Residual Shelf Life ; ( iv ) is adulterated within the meaning of the U.S. Food, Drug, and Cosmetic Act or similar provisions under Applicable Standards ; and/or ( v ) is considered to contain a de fect as determined under governing law and Applicable Standards in the Territory . shall be interpreted accordingly . For the avoidan ce of doubt, any Product that NOVARTIS is entitled to reject pursuant to the Quality Agreement shall be regarded as Defective Product for the purpose of this Agreement