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. 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. 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. (a) Merck hereby transfers all right, title and interest in and to the IND to Scynexis as of the Effective Date.
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. On the Effective Date, Unigene shall execute and deliver to Xxxxx letters addressed to the applicable Regulatory Authority of each country in which Unigene has filed a Calcitonin IND, a form of which, applicable to the United States, is attached hereto as Schedule 5, pursuant to which Unigene assigns, or seeks permission from such Regulatory Authority to assign, to Xxxxx each such Calcitonin IND (the “IND Assignments”). Subject to Unigene’s receipt of the payment specified in Section 4.1, Xxxxx shall have the right to file the IND Assignments with the applicable Regulatory Authorities or to cause Unigene to file such IND Assignments in those countries where Xxxxx is not permitted by such Regulatory Authority to make such filing on Unigene’s behalf. Until such time as the assignment of each Calcitonin IND becomes effective, Unigene hereby grants to Xxxxx a Right of Reference in the Field in the Territory to the data included in all regulatory filings by Unigene related to the Licensed Calcitonin Product to the extent necessary or useful to fully exercise the rights granted to Xxxxx hereunder. Unigene will provide a signed statement to effect this Right of Reference, if requested by Xxxxx, in accordance with 21 C.F.R. § 314.50(g)(3) or any foreign counterpart to such regulation, for the purpose of Xxxxx exercising its rights or performing its obligations under this Agreement. Without limiting the foregoing, Unigene agrees to execute, acknowledge and deliver any such further documents and to do such other acts as may be reasonably necessary or reasonably appropriate in order to carry out the purpose and intent of this Section 3.1(c), at Xxxxx’x cost and expense, provided that Unigene shall notify Xxxxx of any such costs and expenses that Unigene would expect to be incurred prior to taking any such acts, and such costs and expenses shall be approved by Xxxxx in writing prior to Unigene’s taking such acts, it being understood that if Xxxxx refuses to approve such costs and expenses, Unigene shall have no obligation to take such acts.
Transfer of IND. Contemporaneously with the execution of this Agreement, B&D shall execute and deliver to the Reserarch Foundation to hold in escrow (i) the IND Transfer of Ownership and (ii) a power of attorney, in the form attached hereto as Exhibit D, empowering the Research Foundation as their joint and several attorney-in-fact, with full authority, to date, finalize and deliver the executed IND Transfer of Ownership to the FDA for the benefit of BTC or its designee at BTC’s request provided that (i) BTC is not in default under this Agreement or the Research Agreement and (ii) BTC has complied with the utilization requirements set forth in Section 12.3 below. The Research Foundation shall deliver a copy of the finalized IND Transfer of Ownership to BTC and the B&D for their records promptly after delivery of the same to the FDA.
Transfer of IND. Precision will use its Commercially Reasonable Efforts to assign and transfer within [***] all of its rights, title and interests in and to any INDs and orphan drug designations for the Licensed Products. Imugene will cooperate in connection therewith and shall perform all duties under such INDs and orphan drug designations from and after assignment. Subject to the foregoing, the Parties will reasonably cooperate to ensure an orderly transition of duties under such INDs and orphan drug designations and to fulfill applicable filing obligations with Regulatory Authorities. Imugene will not transfer or otherwise assign to an Affiliate or Third Party any such Regulatory Filing that was in existence as of the Effective Date and was transferred to Imugene pursuant to this Section 4.1.6 without obtaining a Right of Reference to such Regulatory Filing for Precision, its Affiliates and any of its licensees consistent with Section 5.3; any purported assignment or transfer that is not in compliance with the foregoing shall be null and void.
Transfer of IND. On a date mutually agreed by the Parties in writing, but no later than [ * ]; provided, however, that the Parties may mutually agree to extend such date if Exelixis has not transferred to Helsinn [ * ] with respect Exelixis’ IND No. 66588 by [ * ] period (the “IND Transfer Date”), Exelixis shall notify the applicable Regulatory Authorities in writing that it is transferring Exelixis’ IND No. 66588 for Becatecarin to Helsinn pursuant to Section 2.7, and Helsinn shall notify the applicable Regulatory Authorities in writing that it is accepting such IND and all responsibilities associated therewith, including without limitation, the responsibility for reporting adverse events. If Helsinn does not satisfy the applicable Regulatory Authorities’ requirements for holding an IND, then Helsinn shall either: (i) engage an entity that satisfies such requirements to accept such IND and its associated responsibilities on behalf of Helsinn; or (ii) enter into a contractual relationship with one or more entities for the provision of services such that Helsinn is able to satisfy such Regulatory Authorities’ requirements. 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. If Helsinn fails to do so, then Exelixis may, at Helsinn’s expense, make whatever arrangements it believes are appropriate to ensure the full and complete transfer of the IND to Becatecarin to Helsinn or Helsinn’s agent on the IND Transfer Date.
