definiens: means, as set forth on Exhibit B hereto, for each Product, withAMAG having primary responsibility with respect to the Drug and Prefilled Syringe, andAntares having primary responsibility with respect to the Devices and Components, thefollowing documents relating to such Product:(a)specifications for Devices, Prefilled Syringes and Components;(b)the Product Specifications ; and(c)storage, packaging, prescribing information and label specifications andrequirements ; andall as updated, amended and revised from time to time by the Parties in writing inaccordance with the terms of this Agreement, and in all cases including compliance with allApplicable Laws and the Quality Agreement ; has the meaning specified in Section 2.6(a ) ; means any action ( i ) by AMAG to recover title to or possession of quantities of theProducts, sample Products and/or Trainers sold or shipped to third parties ( including, without limitation, the voluntary withdrawal of Products, sample Products and/or Trainers)from the market ) ; or ( ii ) by any Regulatory Authorities to detain or destroy any of theProducts and/or the sample Products