IND(s) means an investigational new drug application as defined in 21 C.F.R. Section 312 et seq for the FDA in the United States or equivalent application to the Competent Authorities of other countries in the Territory, to commence clinical testing of a drug in humans, as defined by the FDA in the United States, or other applicable Competent Authority, as the same may be amended, supplemented or replaced from time to time.
IND(s) means all Investigational New Drug Applications sponsored by Seller covering the clinical investigation of any Business Product and filed with the FDA, or the equivalent application filed with the relevant Health Authority in a country other than the United States.
IND(s) means any investigational new drug application filed with Regulatory Authorities in the Territory for approval to perform a clinical trial.
More Definitions of IND(s)
IND(s) means investigational new drug applications for FDA authorization to administer an investigational drug to humans.
IND(s) means an Investigational New Drug as defined in FFDCA and related regulations.
IND(s) mean (a) any investigational new drug application relating to the Compound filed with the FDA pursuant to 21 C.F.R. Part 312 (a “U.S. IND”) and any foreign equivalent of the foregoing, and (b) all supplements, protocols and amendments that may be filed with respect to the foregoing.
IND(s) is defined in Section 3.8(d) of the Agreement.
IND(s) shall have the meaning set forth in Section 3.18(b).
IND(s) means all investigational new drug applications in effect, as described in the FD&C Act, and any corresponding or equivalent foreign registrations and approvals required by any Regulatory Authority of a country, group of countries or territory other than the United States associated with the conduct of nonclinical and clinical studies of pharmaceutical products. 1.54 “Indemnitee” has the meaning set forth in Section 9.3.1. 1.55 “Indemnitor” has the meaning set forth in Section 9.3.1.
IND(s) means Investigational New Drug applications filed with the FDA, and all supplements, amendments and revisions thereto or any comparable registration of a Foreign Jurisdiction.