IND

IND. An Investigational New Drug application, or similar application or submission, filed by Company or any other Licensed Entity 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. An application filed with a Regulatory Authority for authorization to commence clinical trials, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or regulatory jurisdictions, (e.g., clinical trial application (CTA)), and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.

IND. Means an Investigational New Drug application filed with the FDA, a Clinical Trial Application filed with the EMA or any equivalent in any country where a regulatory filing is required or obtained for commencement of human clinical trials of a pharmaceutical product.

IND. Means an Investigational New Drug Application, or the equivalent submission in any country, submitted to a Regulatory Agency.

IND. With respect to a particular LICENSED PRODUCT, an Investigational New Drug application submitted to the FDA, or a corresponding application filed with any other regulatory agency, seeking approval to begin tests of a new drug in human subjects.

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).

IND. Means an Investigational New Drug Application filed with the FDA or the equivalent application or filing filed with any equivalent agency or government authority outside of the United States (including any supra-national agency such as in the European Union) necessary to commence human clinical trials in such jurisdiction, and including all regulations at 21 CFR § 312 et. esq., and equivalent foreign regulations.

IND. An Investigational New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetic Act.

IND. An Investigational New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetic Act, with the FDA or any corresponding application in any country or regulatory jurisdiction other than the U.S.