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. 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. The Company acknowledges that the IND Sponsor has submitted the Protocol with the U.S. FDA to the already active IND #13967. The IND will satisfy all of the requirements of the FDA. The NHLBI acknowledges that the Company has provided the IND Sponsor with a letter of cross-reference to all pertinent regulatory filings (including IND 13335) sponsored by the Company for the limited purpose of IND Application 13967. The Company acknowledges that it has received from the IND Sponsor a letter granting the FDA permission to cross-reference the IND filed by the Sponsor for this Clinical Trial for other regulatory submissions provided by Company. Accordingly, NHLBI and the IND Sponsor hereby grant Company a right to cross-reference relevant data within IND Application 13967 for purposes of developing and commercializing Company’s products, including without limitation the Test Article.
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. Promptly after the Settlement Effective Date the Parties will cooperate to transfer the IND included in the Transferred Registrations to TRIS.
