Common use of IND Clause in Contracts

IND. “IND” shall mean (a) (i) an Investigational New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder, that is required to be filed with the FDA before beginning clinical testing of a pharmaceutical product in human subjects, or any successor application or procedure and (ii) any foreign counterpart of such an Investigational New Drug Application, and (b) all supplements and amendments that may be filed with respect to the foregoing.

IND. “The term "IND” " shall mean (a) (i) an Investigational New Drug Application, as defined in application for investigation of a new drug that has been submitted to the U.S. FDA pursuant to the Federal Food, Food Drug and Cosmetic Act, as amendedamended [Title 21, United States Code] and the regulations promulgated thereunder, that is required or an equivalent application to be filed with the FDA before beginning clinical testing of a pharmaceutical product in human subjects, or any successor application or procedure and (ii) any foreign counterpart of such an Investigational New Drug Application, and (b) all supplements and amendments that may be filed with respect to the foregoinganother Regulatory Authority.

IND. “IND” shall mean (a) (i) an Investigational New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetic FD&C Act, as amended, and the regulations promulgated thereunder, that is required to be filed with the FDA before beginning clinical testing of a pharmaceutical product Product in human subjects, or any successor application or procedure and (ii) any an equivalent foreign counterpart of such an Investigational New Drug Application, and (b) all supplements and amendments that may be filed with respect to the foregoingfiling.

IND. The term “IND” shall mean (a) (i) an Investigational New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder, that is required to be Application filed with the FDA before beginning clinical testing of a pharmaceutical product in human subjectsFDA, or any successor the equivalent application or procedure and (ii) any foreign counterpart of such an Investigational New Drug Application, and (b) all supplements and amendments that may be filing filed with respect any equivalent Regulatory Authority outside the United States of America (including any supra-national agency, such as in the European Union) necessary to the foregoingcommence human clinical trials in such jurisdiction.

IND. “IND” shall mean (a) (i) means an Investigational New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder, that is required to be investigational new drug application or clinical trial application filed with the FDA before beginning clinical testing of a pharmaceutical product in human subjects, or any successor application or procedure and (ii) any comparable foreign counterpart of such an Investigational New Drug ApplicationGovernmental Body, and (b) including all documents, data, amendments, supplements and amendments other information concerning the applicable drug that may be are necessary for or filed with respect to the foregoingsuch application.

IND. The term “IND” shall mean (a) (i) an Investigational New Drug Applicationinvestigational new drug application, as defined in the U.S. Federal Foodclinical trial application, Drug and Cosmetic Actclinical trial exemption, as amended, and the regulations promulgated thereunder, that is required or similar application or submission for approval to be conduct human clinical investigations filed with the FDA before beginning clinical testing of or submitted to a pharmaceutical product regulatory authority in human subjects, or any successor application or procedure and (ii) any foreign counterpart of such an Investigational New Drug Application, and (b) all supplements and amendments that may be filed with respect to the foregoingcountry.

IND. The term “IND” shall mean (a) (i) an Investigational New Drug Application, application as defined in the U.S. Federal United States Food, Drug & Cosmetic Act and Cosmetic Act, as amended, and the applicable regulations promulgated thereunder, that is required as amended from time to be filed with the FDA before beginning clinical testing of a pharmaceutical product in human subjects, time or any successor application or procedure and (ii) an equivalent application or filing with the applicable Regulatory Authority in any foreign counterpart country other than the United States allowing the commencement of such an Investigational New Drug Application, and (b) all supplements and amendments that may be filed with respect to the foregoinghuman clinical trials.

IND. “IND” shall mean (a) (i) means an Investigational New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetic FD&C Act, as amended, and the regulations promulgated thereunder, that is required to be filed submitted with the FDA before beginning clinical testing of a pharmaceutical product in human subjects, or any successor application or procedure and (ii) any an equivalent foreign counterpart of such an Investigational New Drug Application, and (b) all supplements and amendments that may be filed with respect to the foregoingfiling.

IND. “IND” shall mean (a) (i) an Investigational New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder, that is required to be any investigational new drug application filed with the FDA before beginning pursuant to 21 C.F.R. 312 et seq. (or similar application filed with another Regulatory Authority) to begin clinical testing studies of a pharmaceutical product the Product in human subjectshumans, or any successor application or procedure and (iiapplication(s) any foreign counterpart of such an Investigational New Drug Application, and (b) all supplements and amendments that may be filed with respect to the foregoingthereto.

IND. “IND” shall mean (a) (i) an Investigational New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetic FD&C Act, as amended, and the regulations promulgated thereunder, that is required to be filed with the FDA before beginning clinical testing of a pharmaceutical product in human subjects, or any successor application or procedure and (ii) any an equivalent foreign counterpart of such an Investigational New Drug Application, and (b) all supplements and amendments that may be filed with respect to the foregoingfiling.

IND. “IND” shall mean IND means (a) (i) an Investigational New Drug Application, Application as defined in the U.S. Federal United States Food, Drug and Cosmetic Act, as amended, Act and the applicable regulations promulgated thereunderby the FDA, that or (b) an equivalent application to the equivalent agency in any other country or group of countries, the filing of which is required necessary to be filed with the FDA before beginning commence clinical testing of a pharmaceutical product in human subjects, or any successor application or procedure and (ii) any foreign counterpart of such an Investigational New Drug Application, and (b) all supplements and amendments that may be filed with respect to the foregoinghumans in a particular jurisdiction.

IND. “IND” shall mean (a) (i) means an Investigational New Drug ApplicationApplication submitted to the FDA pursuant to 21 C.F.R. Part 312 (as amended from time to time) with respect to any products of Table of Contents the Company, or the equivalent application or filing submitted to any equivalent agency or Governmental Body outside the United States of America (including any supra-national agency such as defined in the U.S. Federal Food, Drug and Cosmetic Act, as amendedEuropean Medicines Agency), and the regulations promulgated thereunderall supplements, that is required to be filed with the FDA before beginning clinical testing of a pharmaceutical product in human subjectsamendments, or any successor application or procedure variations, extensions and (ii) any foreign counterpart of such an Investigational New Drug Application, and (b) all supplements and amendments renewals thereof that may be filed submitted with respect to the foregoing.