IND. The term “
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. Code § 8-1-26-24, establishes the Underground Plant Protection Account to provide funding for programs established and administered by the Indiana Utility Regulatory Commission as listed below. This project will be (please check at least one box): ☒ A public awareness program concerning underground plant protection. ☐ A training or educational program for contractors, excavators, locators, operators, and other persons involved in underground plant protection. ☐ An incentive program for contractors, excavators, locators, operators, and other persons involved in underground plant protection to reduce the number of violations of Ind. Code chapter 8-1-26. (An incentive program is defined as an initiative that uses financial- or recognition-based motivators to encourage behavioral or cultural changes within organizations that utilize Indiana’s 811 law, with the goal of reducing damages to underground utility facilities.)
IND. Code 20-28-6-2(a)(3)(E)
IND. The term “IND” shall mean an Investigational New Drug Application filed with the FDA, or the equivalent application or filing filed with any equivalent Regulatory Authority outside the United States of America (including any supra-national agency, such as in the European Union) necessary to commence human clinical trials in such jurisdiction.
IND. As of the Effective Date no INDs have been filed or prepared by BMS with respect to the Licensed Compounds. The IND for BMS-* has been or will be closed by BMS.
IND. BMS will assign and transfer within [ * ] after the Effective Date all of its rights, title and interests in and to the active IND [ * ] (but, for clarity, not any CTAs, CTXs or investigational medicinal product dossiers nor any inactive IND) for the Licensed Compounds. Eiger will cooperate in connection therewith and shall perform all duties under such IND from and after such assignment. Subject to the foregoing, the Parties will reasonably cooperate to ensure an orderly transition of duties under such IND and to fulfill applicable filing obligations with regulatory authorities. BMS will continue to conduct and close out any existing CTAs and CTXs in the ordinary course following the Effective Date.
IND. Subject to Section 3.6, OPKO will be responsible for opening and maintaining the IND and subsequent amendments for Trials set out in the Development Plan.
IND. Promptly after the Settlement Effective Date the Parties will cooperate to transfer the IND included in the Transferred Registrations to TRIS.
IND. During the Research Term, subject to Section 2.3, Jounce shall provide to Celgene (a) at least [***] prior to the expected filing of an IND for a particular Development Candidate Specifically Directed to a Collaboration Target, written notice of the expected achievement of an IND filing and a proposed draft of the then-available IND filing, (b) a final copy of the IND along with all associated technical reports within [***] of filing the IND, CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. and (c) any communications to and from the FDA with respect to such IND promptly following such communications.
