IMPD definition

IMPD means an Investigational Medicinal Product Dossier which includes all data required by Regulatory Authorities in the European Union for the performance of clinical trials in one or more European Union member states.

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedBook a Demo

IMPD means: an Investigational Medicinal Product Dossier application or its foreign equivalent.

IMPD means Investigational Medicinal Product Dossier.

Examples of IMPD in a sentence

• In the event of an Objection Notice, IMPD shall have five business days to determine whether or not it agrees with any of the objections and the proposed changes set forth therein.

• If for any reason IPMD and the Investors do not hold the Expert Selection Meeting within fifteen business days of the Objection Consideration Date or are unable to agree on an Expert at the Expert Selection Meeting by the end of such period (the “Expert Consideration Period”), then the Investors, on the one hand, and IPMD, on the other hand, shall promptly select in good faith, by written notice to the other, an Expert that is independent from each of IMPD and Investors (each, a “Selected Expert”).

• Each of the Selected Experts that are selected by IMPD and the Investors shall meet promptly (and in no event later than ten business days following the end of the Expert Consideration Period) in person or by teleconference and select a single nationally or regionally recognized investment bank that is independent from each of IPMD and the Investors to serve as the Expert.

• If, on or before the last business day such five business day period (the “Objection Consideration Date”), IMPD agrees with the Investors’ proposed changes in the Objection Notice, then the Consolidation Transaction Notice shall be modified accordingly to reflect such changes.

• HEMISPHERX is responsible for assuring changes are in accordance with and/or reported to the investigational, marketing and/or any other filing with regulatory agencies (IND, IMPD, CTA, NDA, MA, etc.) and for informing SCIEN of any changes requested by regulatory agencies.

More Definitions of IMPD

IMPD means the documentation accompanying a CTA, comprising information in relation to the quality, manufacture and control of the investigational medicinal product, and data from non-clinical studies and from its clinical use.

IMPD means an Investigational Medicinal Product Dossier, or similar application to commence human clinical testing of a Licensed Product for use in the Field submitted to the EMEA, or its equivalent.

IMPD means an Investigational Medical Product Development filed with the EMEA in Europe.

IMPD means the Investigational Medicinal Product Dossier filed by ▇▇▇▇ with the German Federal Institute for Drugs and Medical Devices, together with the application for the authorization of the ▇▇▇▇ Phase II Trial, reports mentioned therein and updates of such reports, and all supplements and amendments thereto.

IMPD means an Investigational Medicinal Product Dossier, any successor thereto or any other data package for submission to a Regulatory Authority as part of a CTA.

IMPD has the meaning given in clause 2.5;

IMPD means Investigational Medicinal Product Dossier for the Product and the Compound (whether in the form of API or otherwise) manufactured according to Volume 4 of cGMP Guidelines and in particular to Annex 13 of such Guidelines.