definiens: means to the extent permitted by Law, all books and records necessary for, orprepared for the purpose of, the research, development, or commercialization ( but not manufacture ) ofProduct, including all clinical and preclinical reports, laboratory notebooks, patent prosecution files for theHPN-100 Patents, copies of all supplier lists, marketing studies, consultant reports, physician databases, andcorrespondence with respect to the Product to the extent maintained by Seller, all reports to andcorrespondence with the FDA, exception reports and investigations, specifications for raw materials andFDA communication thereon, communication relating to manufacturing or packaging with any of the FDA, vendors or suppliers, and all complaint files and adverse event files with respect to the Product, provided, however, that ( a ) Seller may retain, to the extent in Seller ’s possession a copy of any such books andrecords to the extent necessary for Tax, accounting, litigation or regulatory or reporting requirements, and(b ) any attorney work product, attorney - client communications and other items protected by privilege thatare held by Seller shall be excluded . For the avoidance of doubt, while the Product Records include any andall INDs and NDAs for Product ( including any portions thereof that reference any data, reports, studies, orstudy results for Buphenyl ), Product Records does not include the original books and records for any suchdata, reports, studies, or study results for Buphenyl that were generated by Seller prior to August 23, 2007(which instead are part of the UCD Data )