IND

IND. Means an Investigational New Drug application, as defined in the U.S. Food, Drug and Cosmetic Act ("FDCA") and the regulations promulgated thereunder or any corresponding foreign application, registration or certification.

IND. Means an application for an Investigational Exemption for a New Drug filed with the FDA, or any comparable filing made with a regulatory authority outside the United States.

IND. Shall mean an Investigational New Drug application filed with the Food and Drug Administration in the United States, or any similar filing with any foreign regulatory authority, to commence human clinical testing of a PRODUCT in any country.

IND. Means an Investigational New Drug Application filed with the FDA necessary to commence human clinical trials in conformance with applicable laws and regulations.

IND. An investigational new drug application or the equivalent, which is filed by ViroPharma with the United States Food and Drug Administration (or any successor agency) to obtain approval to conduct clinical studies in the Field in the United States through administration of the Compound and/or Products to human beings, as well as any corresponding applications or approvals for the Compound and/or Products in Canada.

IND. Shall mean an Investigational New Drug application or similar application required to commence human clinical testing of a product submitted to the FDA, or its foreign equivalent.

IND. Means an Investigational New Drug Application filed with FDA, or a similar application to conduct clinical studies filed with an applicable Regulatory Authority outside of the United States.

IND. An Investigational New Drug application for a Licensed Product submitted to the FDA or a comparable application submitted to another Regulatory Agency.

IND. An investigational new drug application (Form FDA 1571) or any successor form or foreign equivalent.

IND. An investigational new drug application and associated documents required to be filed with the FDA or a comparable government agency outside of the United States to obtain approval to commence human clinical trials of a Product.