FDA PIND Submission definition
FDA PIND Submission means the package of materials and relevant supporting reports, documentation, and approvals that was submitted to or received from the FDA or other regulatory authorities with respect to the LDN Formulation, including all (i) regulatory documentation, applications (including investigational new drug applications, NDAs and marketing authorization applications or their equivalents), registrations, licenses, authorizations and approvals; (ii) correspondence and reports submitted to or received from the FDA or other 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 (iii) technological, scientific, development, chemical, biological, pharmacological, toxicological, clinical trial materials, and other data, files, records and other information (in any form or medium, wherever located) similar to the foregoing.