definiens: means the following o wned by or to the extent licensed to Parent as of the Effective Date or the Closing that, in each case is not an Acquired Asset : all Know - How and other information that is necessary to manu facture the Products, that is used in the manufactu re of the Products, or that is intended for use in the manufa cture of the Products, in accordance with the curre nt applicable Regulatory Approvals and as such Products are manuf actured as of the Effective Date or the Closing or intended to be manufactured as of the Closing, including, bu t not limited to, ( i ) the manufacturing process app roved in the applicable Regulatory Approvals, specifications and test methods, raw material, packaging, stability a nd other applicable specifications, manufacturing and packag ing instructions, master formulas, validation repor ts to the extent available, stability data, analytical 88 methods, records of complaints, annual product revi ews to the extent available, and other master docum ents necessary for the manufacture, control and release of the Products, ( ii ) Regulatory Documentation and ( iii ) technological, scientific, chemical, biologic al, pharmacological, toxicological, regulatory and pre - clinical and clinical trial reports, records, materials and information related to the Products