“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 # in the United States, an Investigational New Drug Application, as defined in the FD&C Act,investigational new drug application filed with the FDA that is requiredfor authorization to be filed withcommence clinical studies or any corresponding foreign application in the FDA before conducting a Clinical Trial (includingTerritory and # 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 # in the United States, an Investigational New Drug Application, as defined in the FD&C Act,application or any successor application or procedure filed with the FDA that is required to be filed with the FDA before conductingFDA; # any non-United States equivalent of a Clinical Trial (includingUnited States Investigational New Drug application; and # all supplements and amendments that may be filed with respect to the foregoing); and # any foreign counterpart of the foregoing.

“IND” means an application filed with a Regulatory Authority for authorization to commence Clinical Studies, including # in the United States, an Investigational New Drug Application,Application as defined in the FD&C Act,FFDCA or any successor application or procedure filed with the FDA that is required to be filed with the FDA before conductingFDA, # any equivalent of a United States IND in other countries or regulatory jurisdictions (i.e. Clinical Trial (includingApplication (CTA)), and # all supplementssupplements, amendments, variations, extensions and amendmentsrenewals thereof that may be filed with respect to the foregoing); and # any foreign counterpart of the foregoing.

“IND” means # inshall mean an investigational new drug application with respect to the United States, an Investigational New Drug Application, as defined in the FD&C Act,Licensed Product filed with the FDA that is required to befor beginning clinical trials in humans, or any comparable application filed with the FDA before conductingRegulatory Authorities of a Clinical Trial (includingcountry other than the United States prior to beginning clinical trials in humans in that country, as well as all supplements andor amendments that may be filed with respect to the foregoing); and # any foreign counterpart of the foregoing.such filings.

“IND” means # in the United States, an Investigational New Drug application, Clinical Study Application, as defined in the FD&C Act,Clinical Trial Exemption, or similar application or submission for approval to conduct human clinical investigations filed with the FDA that is requiredor submitted to be fileda Regulatory Authority in conformance 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 counterpartrequirements of the foregoing.such Regulatory Authority.

“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, an Investigational New Drug Application, as defined in the FD&C Act, filedtogether with the FDA that is required to be filed with the FDA before conducting a Clinical Trial (including allany additions, deletions and supplements and amendments that may be filed with respect to the foregoing); and # any foreign counterpart of the foregoing.thereto.