definiens: means, collectively, whether existing before or after the NDA TransferDate : ( a ) all written or electronic filings or submissions made with Regulatory Authorities in satisfaction of applicableregulatory and notification requirements with respect to Products in the Territory ( including, without limitation, AnnualPeriodic Reports, Serious Adverse Drug Experience Reports, Adverse Drug Experience Reports, and filings and submissionsregarding recalls ) ; ( b ) all written or electronic correspondence to or from the FDA with respect to any of the foregoing;(c ) minutes of any meeting between a party and the FDA regarding the Regulatory Approvals, or Manufacture orCommercialization of the Products in or for the Territory ; and ( d ) written summaries of oral communications between a partyand the FDA that would impact, or would reasonably be expected to be material to, the development, Manufacture, commercialization of the Products and/or any ROR Product