“IND” means # an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or # 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” means # in the United States, an Investigational New Drug Application, as defined in the FD&C Act, filed with the FDA that is required to be filed with the FDA before conducting a Clinical Trial (including all supplements and amendments that may be filed with respect to the foregoing); and # any foreign counterpart of the foregoing.

“IND” means an application submitted to a Regulatory Authority to initiate human clinical trials, including # an Investigational New Drug application or any successor application or procedure filed with the FDA; # any non-United States equivalent of a United States Investigational New Drug application; and # all supplements and amendments that may be filed with respect to the foregoing.

“IND” means # an investigational new drug application filed with the FDA for authorization to commence clinical studies or any corresponding foreign application in the Territory and # all supplements and amendments that may be filed with respect to the foregoing.

“IND” means an application filed with a Regulatory Authority for authorization to commence Clinical Studies, including # an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, # any equivalent of a United States IND in other countries or regulatory jurisdictions (i.e. Clinical Trial Application (CTA)), and # all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.

“IND” means an Investigational New Drug application (as more fully defined in 21 C.F.R. Part 312, et. seq.) filed with the FDA, or the equivalent application filed with any equivalent agency or governmental authority.

“IND” means 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 or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.

“IND” shall mean an investigational new drug application with respect to the Licensed Product filed with the FDA for 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, as well as all supplements or amendments filed with respect to such filings.

“IND” means an “Investigational New Drug Application” Filed by or on behalf of Denali with the FDA pursuant to 21 C.F.R. 312.23 before commencing clinical trials with a Licensed Product, or any comparable Filing with a relevant Regulatory Authority in a country other than the United States, together with any additions, deletions and supplements thereto.

“IND” means an Investigational New Drug Application, as described in 21 CFR part 312, or other equivalent name that is defined by the Regulatory Authority, which must be approved by Regulatory Authority or otherwise go into effect prior to conducting clinical trials with respect to a Product in the Territory.