“Regulatory Documentation” means all # applications (including all INDs and Drug Approval Applications and other regulatory filings), registrations, licenses, authorizations, and approvals (including Regulatory Approvals), # correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, adverse event files, and complaint files, and # Clinical Data and data contained or relied upon in any of the foregoing, in each case ((i), (ii), and (iii)) relating to a Licensed Compound or Licensed Product.

“Regulatory Documentation” means all # applications (including all INDs, Drug Approval Applications and BLAs), registrations, licenses, authorizations and approvals (including Regulatory Approvals), # correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), and all supporting documents with respect thereto, including all adverse event files and complaint files, and # clinical and other data contained or relied upon in any of the foregoing; in each case of (a), (b) and (c) pertaining to a Licensed Product or an RTGel Component.

“Regulatory Documentation” means all applications, registrations, licenses, authorizations and approvals (including all INDs and Regulatory Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents and all clinical studies and tests, solely relating to a Product, and all data contained in any of the foregoing, including all INDs, drug approval applications, regulatory drug lists, advertising and promotion documents, clinical data, adverse event files and complaint files but excluding Drug Master Files.

“Regulatory Documentation” means, with respect to a Product Candidate or Licensed Product, all INDs, NDAs, and other regulatory applications submitted to any Regulatory Authority, copies of Regulatory Approvals, regulatory materials, drug dossiers, master files (including Drug Master Files, as defined in 21 C.FJL §314.420 and any non-United States equivalents), and any other reports, records, regulatory correspondence, meeting minutes, telephone logs, and other materials relating to Regulatory Approval of Product Candidates or Licensed Products (including any underlying safety and effectiveness data whether or not submitted to any Regulatory Authority), or required to manufacture, distribute or sell the Licensed Product including any information that relates to pharmacology, toxicology, chemistry, manufacturing and controls data, batch records, safety and efficacy, and any safety database required to be maintained for Regulatory Authorities.