Existing IND Sample Clauses
The 'Existing IND' clause defines the status and handling of an Investigational New Drug (IND) application that has already been filed with regulatory authorities prior to the agreement. This clause typically specifies which party owns or controls the IND, outlines any obligations regarding its maintenance, and may address how the IND will be referenced or used in connection with the collaboration or project. Its core practical function is to clarify rights and responsibilities related to the pre-existing regulatory filing, thereby preventing disputes over access, use, or ownership of the IND during the course of the agreement.
Existing IND. As of the Effective Date, FivePrime holds an IND for FP-1039 in the U.S. with the IND No. *** (FP-1039) (the “Existing IND”), under which it is conducting the FivePrime-Conducted Trials. As of the Effective Date, FivePrime plans to complete the FP-1039 Phase 1 Trial, and to continue conducting the FP-1039 Endometrial Trial (FP-1039-002) in the U.S. under the same IND and in other countries under INDs to be filed in such other countries that are substantially foreign equivalents of the Existing IND (such future INDs, the “Endometrial Foreign INDs”).
Existing IND. OGX shall hold, under the direction and control of the JSC, the U.S. IND for Licensed Products that exists as of the Effective Date (“Existing IND”), until such time as either Teva or OGX requests such Existing IND to be transferred to Teva, at which time OGX shall promptly transfer the Existing IND to Teva.
Existing IND. Array shall retain ownership, and remain the sponsor, of the Initial IND until the last patient visit in the 403 MAD and the 403 Bioequivalence Trial. Array shall notify Amgen within fifteen (15) days after the occurrence of the last patient visit in the 403 MAD and the 403 Bioequivalence Trial. Upon the request of Amgen following such event, Array shall transfer the Initial IND to Amgen or, if directed by Amgen, close or inactivate the Initial IND as soon as reasonably practicable. Array shall complete all relevant clinical trial and Initial IND administrative activities for the 403 MAD and the 403 Bioequivalence Trials and shall promptly, on a regular basis and as requested by Amgen, share all clinical trial data with Amgen. Amgen shall be responsible for the preparation and filing of all subsequent IND(s) or other regulatory filings with respect to any clinical development for ARRY-403 other than the 403 SAD, 403 MAD and 403 Bioequivalence Trial.
Existing IND. Vical has sufficient legal and/or beneficial title and ownership in the Existing IND sufficient to transfer such Existing IND to Astellas in accordance with Section 4.1; no Regulatory Authority has, to Vical’s knowledge, commenced or threatened to initiate any action or proceeding to refuse to file, reject, not approve, or withdraw the Existing IND, nor has Vical received any notice to such effect; and to Vical’s knowledge, Vical is not in violation of any applicable laws that could reasonably be expected to form the basis for such an action.