IND Transfer Date definition

IND Transfer Date has the meaning set forth in Section 4.3.1 (Licensed Product INDs).

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedBook a Demo

IND Transfer Date means, if the IND is initially submitted by OvaMed, the effective date of transfer of the IND to Coronado, in accordance with the terms of this Amendment.

IND Transfer Date has the meaning set forth in Section 3.3.1(b).

Examples of IND Transfer Date in a sentence

• Following the IND Transfer Date, Licensee or its relevant Affiliates will have the sole right to file and hold all Regulatory Materials (including any Assigned Regulatory Materials) for the Licensed Compounds and Licensed Products in the Field in the Licensee Territory.

• Subject to the foregoing, from and after the IND Transfer Date, Fujisawa, under the oversight of the JDMC, shall have primary regulatory responsibility for the Indication in the Field in the Territory.

• This Section 3.3 will apply from the Effective Date until the Relay IND Transfer Date and thereafter Section 3.4 shall apply.

• Exelixis shall provide interim adverse experience and safety reporting services on Helsinn’s behalf between the Effective Date and the IND Transfer Date.

• To effect transfer of the IND, on the day immediately preceding the IND Transfer Date each Party shall submit to the U.S. Food and Drug Administration (“FDA”) mutually acceptable correspondence, in the form of Exhibit 3 and Exhibit 4 hereto, respectively, transferring all rights and responsibilities with respect to the IND from Investigator to Company.

• Institution and the Investigator will notify Company in writing immediately if any change occurs with respect to the status of the IND on or before the IND Transfer Date.

• Prior to or on the IND Transfer Date, Takeda will submit written notification to the FDA informing it of the transfer of the Phase II Ongoing Trials Regulatory Submissions from Takeda to Neurocrine.

• Except as set forth in Sections 3.3.2 and 3.4.2, (a) Relay will be responsible for [***] up to the Relay IND Transfer Date, (b) after the Relay IND Transfer Date, [***], and (c) otherwise each Party shall bear its own costs and expenses in performing its responsibilities and activities with respect to the Relay Phase Ia Trial.

• Beginning on the IND Transfer Date, Helsinn and/or its agents shall assume all responsibility for all correspondence and communication relating to the Product with Regulatory Authorities, and the physicians and other health care professionals.

• Anytime after the Relay IND Transfer Date, notwithstanding anything in the foregoing, if Licensee may request by written notice to Relay that the conduct of the Relay Phase Ia Trial be transferred to Licensee, in whole or in part, such that Licensee has the sole right and responsibility for the conduct of such transferred Relay Phase Ia Trial.

More Definitions of IND Transfer Date

IND Transfer Date has the meaning set forth in Section 3.3.1(b). [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Table of Contents

IND Transfer Date has the meaning set forth in Section 4.2.1(a) (Clinical Trial Regulatory Submissions).

IND Transfer Date has the meaning set out in Section 6.5(b). (eee) "Intellectual Property" means Patent Rights, trade names, trademarks, copyright, trade secrets, trade dress, industrial and other designs, trade secrets, or Know-How, and other forms of intellectual property, all whether or not registered or protected, or capable of such registration or protection. (fff) "JDMC" has the meaning as set out in Section 2.4(a). (ggg) "Jointly Owned Patents" has the meaning set out in Section 7.3(a). (hhh) "Know-How" means any and all know-how, trade secrets, inventions, data, processes, techniques, procedures, compositions, devices, methods, formulas, protocols, any and all pre-clinical and clinical data, and information, whether or not patentable, including any and all chemical, biochemical, toxicological, and scientific research information, whether in written, electronic, graphic or video form or any other form or format. (iii) "knowledge" or "best of its knowledge" means, with respect to each Party, the actual knowledge of the senior officers of such Party, without the duty of inquiry. Specifically, with regard to Fujisawa, senior officers shall mean only the Senior Vice President of Finance, Chief Executive Officer, Senior Vice President of New Product Planning and Licensing, Executive Vice President and Vice President and General Counsel. Specifically with regard to Cardiome, senior officers shall mean only the Director of Intellectual Property, Chief Financial Officer, Vice President of Commercial Affairs, Chief Executive Officer, and Chief Scientific Officer and Executive Vice President Clinical Development and Regulatory Affairs.

IND Transfer Date has the meaning set out in Section 3.1.1. 1.1.79 “Indemnified Party” has the meaning set out in Section 19.3. 1.1.80 “Indemnifying Party” has the meaning set out in Section 19.3.

IND Transfer Date has the meaning set out in Section 6.5(b).