INDs definition
INDs means an investigational new drug application as defined in 21 C.F.R. Part 312 et seq in the United States (as may be amended, supplemented or replaced from time to time), or equivalent application to any Competent Authority of any other country in the Territory, to commence clinical testing of a drug, including but not limited to any amendments, supplements, or supporting correspondence with respect thereto.
INDs 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.
INDs means investigational new drug applications for FDA authorization to administer an investigational drug to humans.
More Definitions of INDs
INDs shall have the meaning set forth in Section 3.18(b).
INDs means any investigational new drug application filed with Regulatory Authorities in the Territory for approval to perform a clinical trial.
INDs 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.
INDs means an Investigational New Drug as defined in FFDCA and related regulations.
INDs is defined in Section 3.8(d) of the Agreement.
INDs means investigational new drug applications, including any amendments or supplements thereto, reports, correspondence and other submissions related thereto and any other regulatory and clinical files with data pertaining to the foregoing owned or Controlled or in the possession of Seller as of the Execution Date and/or the Effective Time, including any and all information, data, know-how, formulations, assays, good will, or intellectual property (except for the Excluded INDs) contained therein, including the investigational new drug applications identified on Schedule 1.1(e).
INDs means all investigational new drug applications in effect, as defined in the Act, as amended, and the regulations promulgated thereunder, and other related registrations and approvals required by any Governmental Entity associated with the conduct of nonclinical and clinical studies of pharmaceutical products.