definiens: has the meaning specified in Section 3.2(a ) ; has the meaning specified in Section 3.2(c ) ; means a day other than a Saturday, Sunday or a day that is a federalholiday in the United States ; means a three - month period ending on March 31, June 30, September30 or December 31 ; means a calendar year occurring after the Effective Date ; provided, however, the first Calendar Year means the period from the Effective Date up to andincluding December 31 of the same calendar year in which the Effective Date occurs ; has the meaning specified in Section 3.2(c ) ; means a document signed by an authorizedrepresentative of [COMPANY] or the Subcontractor that conducted the applicable analysis, inreasonable and customary form, that : ( i ) describes the specifications for, and testingmethods applied to, the quantity of each of the Major Device Components manufactured byor on behalf of [COMPANY] pursuant to this Agreement, and the results of such testing, and ( ii)certifies that such quantity of each of the Major Device Components was manufactured inaccordance with cGMP, all other Applicable Laws, and the Product Specifications ; means a document signed by an authorizedrepresentative of AMAG, its agent or its permitted subcontractor that conducted theapplicable analysis, in reasonable and customary form, that : ( i ) describes the specificationsfor, and testing methods applied to the Drug manufactured by or on behalf of AMAGpursuant to this Agreement, and the results of such testing, and ( ii ) certifies that suchquantity of Drug was manufactured in accordance with cGMP, all other Applicable Laws, and the Product Specifications ; means a document signed by an authorizedrepresentative of AMAG, its agent or its permitted subcontractor that conducted theapplicable analysis, in reasonable and customary form, that describes the specifications for, and testing methods applied to, the Drug manufactured by or on behalf of AMAG pursuant tothis Agreement for identification of the Drug, and the results of such testing ; means a document signed by an authorizedrepresentative of AMAG, its agent or its permitted subcontractor that conducted theapplicable analysis, in reasonable and customary form, that : ( i ) describes the specificationsfor, and testing methods applied to, the quantity of Product and/or sample Productmanufactured by or on behalf of [COMPANY] pursuant to this Agreement, and the results of suchtesting, and ( ii ) certifies that such quantity of Product and/or sample Product was- 3 - [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HASBEEN REQUESTED