definiens: means ( a ) all material regulatory applications, submissions, notifications, communications, correspondence, regi strations, protocols or other filings made or submi tted to and all resulting permits, approvals, authorizations or clearances, received from any Governmental or Regu latory Authority ( including minutes of meeting with Govern mental or Regulatory Authority ) that are necessary or used ( i ) in the conduct of the Business or ( ii ) to obtai n and maintain any material approval for the resear ch, study, development, manufacture, marketing, sale or other commercialization of any Product ( including Marketi ng Authorizations and applicable approvals of labeling, price and reimbursement for such therapeutic prod uct ) ( collectively, ) ; and ( b ) all material files related to any Regulatory Auth orization, including dossiers, reports, data and other written materials filed as part of or referenced in any Re gulatory Authorization