definiens: means, collectively, whetherexisting before or after the Closing Date : ( a ) all written or electronic filings orsubmissions made with Regulatory Authorities in satisfaction of applicable regulatoryand notification requirements with respect to Products in the Territory ( including, without limitation, Annual Periodic Reports, Serious Adverse Drug ExperienceReports, Adverse Drug Experience Reports, and filings and submissions regardingrecalls ) ; ( b ) all written or electronic correspondence to or from the FDA with respect toany of the foregoing ; ( c ) minutes of any meeting between a party and the FDAregarding the Regulatory Approvals, or Manufacture or Commercialization of theProducts in or for the Territory ; and ( d ) written summaries of oral communicationsbetween a party and the FDA that would impact, or would reasonably be expected tobe material to, the development, Manufacture or commercialization of the Products