Regulatory Documentation

Regulatory Documentation. Means all applications, registrations, licenses, authorization and approvals (including all Regulatory Approvals), all correspondence submitted to or received from the FDA or any Foreign Regulatory Authority (including minutes and official contact reports relating to any communications with the FDA or any Foreign Regulatory Authority) and all supporting documents and data contained in any of the foregoing (including any INDs or foreign equivalents, any manufacturing facility validation and/or... licensure, any Drug Approval Applications, orphan drug applications, and any other documents related to Regulatory Approvals) in Licensor's possession or control. 4 View More

Regulatory Documentation. Shall mean one copy of Regulatory Approvals and all correspondence submitted to or received from the FDA or any similar Governmental Entity (including minutes and official contact reports relating to any communications with the FDA or similar Governmental Entity) and all supporting documents and data comprising the foregoing.

Regulatory Documentation. Means (a) all Regulatory Filings; (b) all correspondence and reports submitted to or received from any 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 (c) clinical and other data contained or relied upon in any of the foregoing, in each case... relating to any Acquired Compound. View More

Regulatory Documentation. Means all appropriate future and then currently available documents, including but not limited to applications, registrations, licenses, authorizations and approvals, all appropriate future and then currently available correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all appropriate future and then currently available supporting documents and all appropriate future... and then currently available clinical studies and tests, relating to L-DOPS, and all appropriate future and then currently available data contained in any of the foregoing, including all appropriate future and then currently available regulatory drug lists, advertising and promotion documents, adverse event files and complaint files possessed by DSP that are useful or necessary for Exploiting the Licensed Product and obtaining the Marketing Authorization Approvals in the Territory. Regulatory Documentation includes, but is not limited to the documents set forth in Exhibit B attached hereto. View More

Regulatory Documentation. With respect to the Licensed Compound and Licensed Products, all INDs, NDAs, and other regulatory applications submitted to any Regulatory Authority, Regulatory Approvals, pre-clinical and clinical data and information, regulatory materials, drug dossiers, master files (including Drug Master Files, as defined in 21 C.F.R. § 314.420 and any non-United States equivalents), and any other reports, records, regulatory correspondence, and other materials relating to Development or Regulatory Approval... of the Licensed Compound or a Licensed Product, or required to manufacture, distribute, or sell the Licensed Products, including any information that relates to pharmacology, toxicology, chemistry, manufacturing, and controls data, batch records, safety and efficacy, and any safety database View More