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. (a) Merck hereby transfers all right, title and interest in and to the IND to Scynexis as of the Effective Date.
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. 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, Melior hereby transfers and assigns to Biodexa the IND for the Licensed Product (075144) filed with the FDA by Melior or Bukwang with respect to the Licensed Product and, pursuant to Section 3 below, any information in Melior’s or Bukwang’s control requested by Biodexa and required for Biodexa to take over such IND sponsorship, or reasonably requested by Biodexa with respect to the Development and Manufacture of the Compound and Licensed Product. Upon Biodexa’s request and subject to Section 3, Melior shall provide to Biodexa (A) electronic copies of all filings with Governmental Authorities and all other material documents including communications, reports, white papers, supporting material and Manufacturing data generated by or on behalf of Mxxxxx with respect to the Compound or Licensed Product and (B) any other Know-How that is necessary or reasonably useful, for the Development, Manufacture or Commercialization of the Licensed Product, in each case, to the extent that such information was not previously provided by Melior to Biodexa.
Transfer of IND. On-Going Studies. Promptly after completion of any on-going Phase I studies, Sepracor shall use reasonable efforts to transfer Sepracor's IND [**] to Lilly. In addition, Sepracor shall proceed with the orderly completion of any other on-going studies, including toxicology studies, and transfer of any data or information arising therefrom, necessary to timely and efficiently commence or complete any clinical studies. This obligation shall also apply to any other Regulatory Application, data, or information in Sepracor's possession or control for Product in any other country.
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. 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.
