Transfer of IND. In order to facilitate PPD’s accomplishment of the responsibilities outlined in Section 2.1, above, (i) within fifteen (15) business days of the Effective Date, Xxxxxxx shall assign all right, title, and interest in the Existing IND(s) to PPD, transfer the Existing IND(s) into PPD’s name, (ii) use Diligent Efforts, to supply PPD with copies of any Information that is necessary for PPD’s Development of Licensed Products, including but not limited to such Development in accordance with the Pre-Phase III Development Plan, (iii) Xxxxxxx will use Diligent Efforts to supply any other Information that is necessary for PPD’s Development of the Licensed Product in a reasonable time period, as reasonably requested by PPD from time-to-time, and (iv) Xxxxxxx shall supply reasonable technical support to supplement the copies of Information supplied under this section but not to exceed a total of [*]. For the purpose of clarity, any transfer of Information under this Section shall not include Manufacturing Know-How.
Transfer of IND. Medarex and Celldex shall cooperate to make all required regulatory filings to transfer the MDX-1307 IND to Celldex. Such cooperation shall include agreement in respect of the timing of such transfer, it being acknowledged that, as of the Effective Date, Celldex may not be in a position to assume the management of the MDX-1307 IND. Until such time as the MDX-1307 IND is transferred to Celldex, Medarex shall hold the MDX-1307 IND in trust for Celldex, and Celldex and Medarex may agree that Medarex perform certain regulatory responsibilities relating to the MDX-1307 IND under that certain Master Services Agreement being executed by the Parties contemporaneously herewith.
Transfer of IND. (a) Merck hereby transfers all right, title and interest in and to the IND to Scynexis as of the Effective Date.
(b) Scynexis and Merck shall file the Scynexis FDA Letter and the Merck FDA Letter, respectively, with the FDA within one (1) business day after the Effective Date. Scynexis shall be responsible for the payment of any filing or similar fees payable to the FDA with respect to the transfer of the IND and the Program Compound to the Scynexis.
Transfer of IND. Promptly following the Closing Date, BioNumerik will transfer the Tavocept Investigational New Drug (IND) application (IND No. 51,014) to Lantern. Lantern and BioNumerik will coordinate in executing and filing with FDA the documents necessary to evidence such transfer, including documentation from BioNumerik stating that all rights to the IND application have been transferred to Lantern, and documentation from Lantern stating that Lantern has assumed the obligations under the IND application and is committing to the agreements and conditions contained in the IND application. In addition, Lantern agrees to prepare and file clinical study reports relating to Tavocept clinical trials conducted prior to the Effective Date, as may be required to be filed from time to time pursuant to FDA or other Regulatory Authority requirements. All costs relating to the preparation and filing of such clinical study reports shall be recoverable by Lantern from future Net Revenue and future payments received by Lantern or its Affiliates from Third Party Transactions, prior to making any royalty or sharing payments pursuant to Section 3.4 or Section 3.5.
Transfer of IND. Within ninety (90) days after the Effective Date, Nektar shall transfer the existing IND for the Product to Bayer; provided, however, that any DMFs for the Device shall remain with Nektar as provided for in Section 5.2(a).
Transfer of IND. As of the Effective Date, Amgen owns in its own name a certain IND filing for Alfimeprase in the Territory, which is set forth in Exhibit C. Subject to Amgen's rights pursuant to this Agreement, Amgen hereby assigns to Hyseq Amgen's entire right, title and interest in and to such IND set forth in Exhibit C; Hyseq shall then assume all responsibility (and become the sponsor and party of record) for regulatory matters therewith, and shall thereafter be designated the "Regulatory Lead" therefor. Hyseq, in consultation with Amgen, shall prepare, file and maintain all regulatory documentation and perform all applicable regulatory activities for each Collaboration Product prior to its respective Transition Date. No later than [***] after the Effective Date, Amgen shall notify Regulatory Authorities in the Territory of the transfer and [***] shall take all actions reasonably necessary to effect or evidence the transfer of such IND to Hyseq. For the avoidance of doubt, the transfer of such IND shall not be effective to transfer to Hyseq the ownership of or the right to practice any Amgen Material and Manufacturing Information. Notwithstanding anything to the contrary in this Agreement, Hyseq shall have the right to receive from Amgen, and Amgen shall provide to Hyseq, any regulatory data or information to which Hyseq, as the holder of any IND in the Territory, is required by law, rule, regulation or a Regulatory Authority having jurisdiction in the Territory, to have access, or which Hyseq reasonably requires in order to carry out its responsibilities as Development Lead and/or Regulatory Lead and/or Commercial [***] INDICATES THAT CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO RULE 24b-2. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Transfer of IND. NPC has an IND with the FDA for the Product (IND No. [ * ]. Promptly after Licensor's receipt of the Upfront License Fee specified in Section 5.1 (unless due to unavoidable translation problems), Licensor shall complete the tasks assigned to it and submit the specified materials to Licensee in accordance with Exhibit C (IND Transfer to Light Sciences). NPC shall transfer the IND and all of NPC's rights and responsibilities in such IND to Licensee. Such transfer shall be substantially in the form as set forth in Exhibit C. Provided Licensor complies with its obligations in accordance with Exhibit C, all subsequent work necessary to make such IND fully compliant with applicable laws and regulations, and to enable Licensee to conduct further development thereon, shall be at Licensee's sole responsibility and cost.
Transfer of IND. Immediately following the execution of this Agreement, Licensor shall transfer the IND for the Product to Licensee, and all reports and data in connection therewith.
Transfer of IND. Medarex and Celldex shall cooperate to make all required regulatory filings to transfer the MDX-1307 IND to Celldex. Such cooperation shall include agreement in respect of the timing of such transfer, it being acknowledged that, as of the Effective Date, Celldex may not be in a position to assume the management of the MDX-1307 IND. Until such time as the MDX-1307 IND is transferred to Celldex, Medarex shall hold the MDX-1307 IND in trust for Celldex, and Celldex and Medarex may agree that Medarex perform certain regulatory responsibilities relating to the MDX-1307 IND under that certain Master Services Agreement being executed by the Parties contemporaneously herewith. *****REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Transfer of IND. In order to facilitate the Development of Program Technology by Licensee, Graphite agrees to transfer to Licensee IND #026858 as soon as reasonably practicable following the Effective Date, and Licensee agrees to accept such transfer. Each Party agrees to execute such documents and perform such other acts, including submission of any required written notification of such transfer to the United States Food and Drug Administration, in each case to the extent necessary or advisable to carry out and give effect to such transfer under applicable Law.
