IND Transfer. As of the Effective Date, Curis hereby transfers and assigns to Genentech all Curis’ right, title and interest in and to United States IND application entitled “CUR-61414 for the Treatment of Basal Cell Carcinoma.” Within a reasonable period of time following the Effective Date, Curis shall take such actions and execute such documents as may be reasonably required to effectuate such transfer and assignment, at Genentech’s expense. Curis will provide to Genentech copies of all regulatory correspondence related thereto.
IND Transfer. Daiichi Sankyo shall transfer [***] (for [***] study) and [***] (for [***] study) to Rain as soon as appropriate after the Effective Date and hereby assigns, effective on the date agreed by the Parties, both INDs to Rain. Rain shall be responsible for the cost of transferring the INDs.
IND Transfer. Within ten (10) days of the Effective Date, (a) Arena shall submit to the FDA letters (substantially set forth on Exhibit F) transferring sponsorship of IND No 73405 to Roivant and (b) Roivant shall submit to the FDA letters (substantially in the form set forth on Exhibit F) accepting transfer of sponsorship of IND No 73405 from Arena.
IND Transfer. Daiichi Sankyo shall, (*), as soon as reasonably practicable following the Effective Date, transfer to Genta all right, title and interest in the IND and DMF for API filed with the FDA, and any other INDs filed with any other Regulatory Authority in any other country in the Territory in existence on the Effective Date, and deliver to Genta all correspondence with the FDA and such other Regulatory Authorities that Genta may reasonably need to conduct its development activities under this Agreement. The Parties agree to jointly notify the FDA by letter of the transfer as soon as reasonably practicable following the Effective Date. Except for the foregoing, Daiichi Sankyo shall be responsible to transmit to the FDA and such other Regulatory Authorities all necessary and appropriate notification and other documentation required to complete the transfer to Genta.
IND Transfer. NeoRx agrees to promptly transfer and assign any IND or equivalent foreign regulatory filing relating to a Pre-Targeting Product that it has filed prior to the Effective Date upon written request from Xxxxxxx.
IND Transfer. [*] MabCare shall transfer and assign to Day One or its designee the Regulatory Materials and Regulatory Submissions for Licensed Compounds and Licensed Products (including CB-002) in the Day One Territory and listed on Schedule 4.1.2, including, the U.S. IND for CB-002 (the “Transferred Regulatory Materials”). Without limiting the foregoing, MabCare shall initiate the transfer and assignment of such Transferred Regulatory Materials [*]. Until such transfer and assignment is complete, MabCare shall maintain the Transferred Regulatory Materials in good standing. In the event that [*].
IND Transfer. Promptly, but no later than 30 days, following the completion of all Post-Marketing Study Services, Buyer and Seller shall (and shall cause their respective Affiliates to) cooperate with one another and use their respective reasonable best efforts to complete, execute and file or cause to be filed with FDA all documentation required to effect the transfer to Buyer or its applicable Affiliate of all INDs held by Seller or any of its Affiliates covering the clinical studies that were the subject of the Post-Marketing Study Services. Each Party shall bear its own costs and expenses in connection with the transfer of such INDs to Buyer or its applicable Affiliate; provided, however, that Buyer shall be responsible for the payment of any filing or similar fees payable to the applicable Governmental Authority with respect to the transfer of such INDs.
IND Transfer. Exelixis hereby agrees to transfer and assign to Helsinn, in accordance with the procedures set forth in Section 3.5, and Helsinn hereby agrees to receive from Exelixis in accordance with such procedures, all of Exelixis’ right, title and interest to Exelixis’ IND No. 66588 for Becatecarin in the United States. Helsinn understands and acknowledges that, with respect to certain Becatecarin clinical trials being conducted in countries outside the United States, Exelixis is the Sponsor of Record, and Exelixis is not the holder of the applicable INDs in such countries because Exelixis does not have a sufficient presence in those countries. Accordingly, Exelixis’ Third Party contractor holds the IND(s) for Becatecarin for those countries. Such IND(s) are listed on Exhibit 2.7, and, prior to the IND Transfer Date (defined in Section 3.5), Exelixis will transfer its rights in such INDs to Helsinn so that Helsinn shall be the Sponsor of Record and/or IND holder, as applicable for such INDs.
IND Transfer. Upon the completion of (a) – (c) below, Plexxikon shall assign and hereby grants, sells, conveys, delivers, assigns and transfers to Licensee (or its designee), and Licensee hereby accepts, the IND for the Licensed Molecules [***] to Licensee:
(a) Licensee enters into an agreement with a contract research organization for the management of the Ongoing Trial, (b) the assignments for each of the Assigned Agreements shall have become effective, and (c) the Licensee activities described in the Transition Plan that are to be completed prior to the assignment of the IND for the Licensed Molecules shall have been completed. Until the date that such transfer of such IND becomes effective, Plexxikon shall be responsible for handling all matters applicable to the holder of the IND involving Regulatory Authorities in the Territory, to the extent not yet assigned and transferred to Licensee, and shall keep Licensee fully informed of all such regulatory matters relating to the Licensed Molecules in the Field in the Territory of which it is aware, including providing Licensee with reasonable advance notice of, and the opportunity to participate in as an observer in (to the extent permitted under Applicable Law), all formal meetings and teleconferences with Regulatory Authorities in the Territory pertaining to the Licensed Molecules in the Field in the Territory.
IND Transfer. Kansas shall (a) at Licensee’s option, either close or inactivate each of the IND(s) for such Licensed Product, or transfer such IND(s) to Licensee, and (b) with Licensee’s input, complete all relevant activities related to such IND as required for Licensee to assume regulatory ownership, as applicable, all within [*] after Licensee’s notice, including the delivery of true, complete, and executed copies of (i) a letter from Kansas to the FDA confirming transfer of the IND to Licensee (which letter shall provide that the transfer shall be effective as of December 14, 2017), (ii) Form 1571, (iii) Form 1572, (iv) Form 3674, and (v) any relevant IRB compliance documents (collectively, the “IND Transfer”), all of which shall be attached hereto as Exhibit C and the information therein shall be true and correct as of December 14, 2017, the effective date of transfer. Licensee shall retain legal counsel to provide direction to Kansas and coordinate all steps of the IND Transfer. Licensee shall bear all costs related to the IND Transfer. Subject to compliance by Kansas with this Agreement, Licensee shall ensure that the IND Transfer is implemented in a timely manner and that it shall not affect the progress of the Study.
