Common use of Transfer of IND Clause in Contracts

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. As of On a date mutually agreed by the Effective DateParties in writing, 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 but no later than [***[ * ]; provided, however, that the Parties may mutually agree to extend such date if Exelixis has not transferred to Helsinn [ * ] after with respect Exelixis’ IND No. 66588 by [ * ] period (the Effective “IND Transfer Date”), Amgen 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 Territory 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 transfer 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 [***] shall take all actions reasonably necessary to effect or evidence the complete transfer of such the IND to HyseqBecatecarin to Helsinn or Helsinn’s agent on the IND Transfer Date. 3.5.1 During the period from the Effective Date until the IND Transfer Date, Helsinn shall reimburse Exelixis for all of Exelixis’ direct and indirect costs of maintaining the existing Phase 3 Clinical Trial for Becatecarin during such period (the “Interim Trial Costs”). For These indirect costs shall be [ * ] per year. On a monthly basis, Exelixis shall invoice Helsinn for the avoidance of doubtInterim Trial Costs for the preceding month and shall send to Helsinn appropriate documentation evidencing such costs, and Helsinn shall pay Exelixis the transfer amount of such IND Interim Trial Costs within [ * ] days of receiving each such invoice. The Interim Trial Costs payments made by Helsinn shall not be effective to transfer to Hyseq the ownership of or the right to practice any Amgen Material nonrefundable 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 PORTIONSnoncreditable.