INDs and NDA Sample Clauses

INDs and NDA. Subject to Section ‎5.1(a)(ii), Protagonist shall file in its name and hold the Rusfertide NDA, and as promptly as practicable after receipt of Regulatory Approval by the FDA in the U.S. for Rusfertide in the Initial Indication, Protagonist shall transfer and assign to Takeda or such Affiliate the Rusfertide NDA and all of Protagonist’s or its Affiliates’ right, title and interest in and to all Regulatory Documentation in the Territory in Protagonist’s Control and possession existing as of the date of such assignment and solely related to Xxxxxxxxxx, provided that, (i) Protagonist shall transfer to Takeda the Rusfertide IND only after the completion of the Rusfertide OLE, (ii) Protagonist shall transfer to Takeda the Clinical Trial Application (CTA) for Xxxxxxxxxx in the EU only after prior written notice from Takeda to do so, and (iii) in the event Protagonist exercises the Rusfertide Opt-Out Right prior to receipt of such Regulatory Approval by the FDA in the U.S. for Rusfertide in the Initial Indication, Takeda shall have the right to request in writing that such transfer and assignment of the foregoing materials be promptly undertaken following Protagonist’s receipt of such request notice. Following such transfer and assignment, all INDs, NDA and Regulatory Documentation solely related to Rusfertide in the Territory shall be owned by and shall be the sole property and held in the name of Takeda or one of its Affiliates. At Takeda’s request (but no earlier than Takeda’s exercise of its assumption right pursuant to Section ‎5.1(a)(ii), receipt of Regulatory Approval by the FDA in the U.S. for Rusfertide in the Initial Indication, or Takeda’s receipt of an Opt-Out Notice informing Takeda of Protagonist’s exercise of the Rusfertide Opt-Out Right pursuant to Section ‎4.4(a)), Protagonist shall, as promptly as practicable after receipt of such request, transfer to Takeda all INDs, NDA and other Regulatory Documentation for Licensed Products other than Rusfertide Controlled by and in the possession of Protagonist, if any, as of the date of such request. Protagonist shall duly execute and deliver, or cause to be duly executed and delivered, as Takeda may reasonably request and at Takeda’s cost (except that such costs shall be a Shared Development Cost with respect to any Licensed Product for which Protagonist has not exercised an Opt-Out Right), such instruments and shall do and cause to be done such acts, including the filing of such assignments, agreements, ...
Sample 1
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Related to INDs and NDA

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