definiens: means all of the following owned by Seller, to the extent either ( i ) included in one ormore of the INDs included in the Purchased Assets with respect to a Current Compound or(ii ) exclusively related to a Current Compound, except where relied upon in the context of a 505(b)(2)NDA for an Other Bendamustine Product without a right of reference : chemistry, pharmacology, toxicology, pre - clinical, clinical, regulatory and manufacturing information and data and technology, and allsubmissions and correspondence with or to any Governmental or Regulatory Authority in the Territoryrelated to Compounds or Products, including, without limitation, ( a ) clinical data, results ( including alltables, listings and graphs ) and reports, case report forms, and other written materials or correspondencefiled with or received from a Government or Regulatory Authority as part of an IND included in thePurchased Assets or other request for a Permit, ( b ) for each of the Current Compounds, the followingitems to the extent used exclusively to manufacture, formulate, test, package, store and stabilize theCurrent Compounds : ( 1 ) Current Compound and raw material specifications ( including the percentagesand specifications of ingredients and any related formulae or flow diagrams ), ( 2 ) standard operatingprocedures ( such as master batch records and applicable supporting procedures ) and relatedmanufacturing, engineering and other manuals ( as applicable ) for the Current Compounds, ( 3 ) copies ofprocess validation reports, method validation reports and applicable method development reports,(4 ) technical storage conditions and stability assay procedures and other assay procedures ( such ascharacterization assays as applicable ) for the Current Compounds, ( 5 ) quality control and release testingprocedures ; ( 6 ) batch documentation ( including copies of executed batch records and dispositionpackages ) for the Compound Inventory and Product Inventory transferred at Closing, and ( 7 ) masterbatch records for the Compound Inventory and Product Inventory transferred at the Closing, in any formwhatsoever, including notebooks, but only to the extent the foregoing may be in Seller ’s possession orcontrol