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.
Promptly after the IND Transfer Date, Arrowhead will transfer or otherwise make available to Takeda copies (in electronic or other format) of other Regulatory Approvals or Regulatory Submissions in the Territory Controlled by Arrowhead or its Affiliates as of the IND Transfer Date and not transferred to Takeda prior to the IND Transfer Date pursuant to Section 4.2.1(a) (Clinical Trial Regulatory Submissions), to the extent such materials specifically relate to the Compounds or any Product.
Prior to or on the IND Transfer Date, Arrowhead will submit written notification to the FDA informing it of the transfer of the Clinical Trial Regulatory Submissions from Arrowhead to Takeda.
After the later of the IND Transfer Date and the NDA Transfer Date, the Assets shall include the NDA and all clinical and non-clinical data, and FDA files and registrations related to the Product in the Territory.
Therefore, to advocate a proposition that foreign lawyers or foreign law firms cannot come into India to advice their clients on foreign law would be a far fetched and dangerous proposition and in our opinion, would be to take a step backward, when India is becoming a preferred seat for arbitration inInternational Commercial Arbitrations.
Such IND(s) are listed on Exhibit 2.7, and, prior to the IND Transfer Date (defined in Section 3.5), Exelixis will transfer its rights in such INDs to Helsinn so that Helsinn shall be the Sponsor of Record and/or IND holder, as applicable for such INDs.
Helsinn shall identify any such entity(ies) and provide documentation of its satisfaction of the relevant Regulatory Authority requirements to Exelixis at least [ * ] days prior to the IND Transfer Date.
No later than one hundred twenty (120) days prior to the anticipated date of the pre-NDA meeting with the FDA for the Indication, or earlier upon the JDMC's request (the "IND Transfer Date"), Cardiome shall transfer to Fujisawa, without any additional consideration, all such Governmental Approvals in the Field (including the IND and CTA) then owned or held by Cardiome.
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.