definiens: means ( a ) all Permits ( including pricing and reimbursement approvals ), and pending applications, agreements, for any thereof, and similar rights obtained from any Regulatory Authorities and/or Gov ernmental Entities, to conduct the Business or take any action in connection with the Seller Products, including, without limitation, NDAs and INDs, toget her with all supporting data, documents, submissions, c orrespondence, reports and clinical studies relatin g thereto ( including, without limitation, documentati on of pharmacovigilance, good clinical practice, go od laboratory practice and good manufacturing practice ) ; ( b ) all adverse event reports and other data, information and materials relating to adverse exper iences with respect to each Seller Product ; ( c ) all written notices, filings, communications or other c orrespondence between Seller, on the one hand, and any Governmental Entity and/or Regulatory Authoriti es, on the other hand, relating to each Seller Product, including any safety reports or updates, c omplaint files and product quality reviews, and cli nical or pre - clinical data derived from clinical studies conducted or sponsored by Seller, which data relate s to each Seller Product ; and ( d ) all other information regarding development, testing, activities pertaini ng to each Seller Product and/or compliance with any law or regulation of any jurisdiction, including audit reports, corrective and preventive action documenta tion and reports, and relevant data and correspondence ; in each case, as maintained by or o therwise that are owned by or in the possession of Seller as of the Agreement Date and as of the Closi ng