IND

IND. Shall mean an investigational new drug application, clinical study application, clinical trial exemption or similar application or submission for approval to conduct human clinical investigations filed with a Regulatory Authority in any country.

IND. The Investigational New Drug Application filed or to be filed with the FDA as described in Title 21 of the U.S. Code of Federal Regulations, Part 312, and the equivalent application in the jurisdictions outside the United States, including an Investigational Medicinal Product Dossier filed or to be filed with the EMA.

IND. Shall mean any filing made with the Regulatory Authority in the Territory for initiating clinical trials in such country with respect to the Product.

IND. Shall mean an investigational new drug application filed with the FDA.

IND. Means an investigational new drug application filed with the FDA prior to beginning clinical trials in humans or any comparable application filed with the regulatory authorities of a country other than the United States, prior to beginning clinical trials in humans in that country.

IND. Shall mean an Investigational New Drug application with an appropriate regulatory authority.

IND. Shall mean an Investigational New Drug Application under the Act (together with all subsequent submissions, supplements and amendments thereto, [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. 6 and any materials, documents or information referred to or relied upon thereby) seeking... authorization to commence clinical trials of the Product in humans, and similar applications or filings in the other countries within the Territory. View More

IND. Means an Investigational NDA in the Territory filed with the FDA.

IND. Means an investigational new drug application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA or (b) the equivalent application to the equivalent Regulatory Authority in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

IND. An Investigational New Drug Application (as described in 21 C.F.R. 312) that is filed with the FDA to initiate the conduct of human clinical trials with a drug/biologic (or an equivalent filing in a jurisdiction outside of the United States filed with an Other Regulatory Agency).