Common use of Initial Data Transfer Clause in Contracts

Initial Data Transfer. (1) Within sixty (60) days after License Option Exercise, MacroGenics shall deliver to Takeda electronic copies (unless otherwise required by Applicable Law) of all Regulatory Materials relating to the Products in the Field in the Territory which are owned or Controlled by MacroGenics. Promptly after such transfer, but in any case within ten (10) Business Days, MacroGenics shall take all steps reasonably necessary to assign all INDs, Regulatory Applications and Regulatory Approvals to Takeda, including submitting to any applicable Regulatory Authority a letter or other necessary documentation (with copy to Takeda) notifying the Regulatory Authority of the assignment. (2) Within ninety (90) days after License Option Exercise, MacroGenics shall make available to Takeda separate electronic copies of all remaining Regulatory Documentation, including the study reports from all non-clinical trials and clinical trials, in each case, whether completed prior to the exercise of the License Option or then in-progress, that are owned or Controlled by MacroGenics (to the extent not previously provided to Takeda). (3) Notwithstanding Section 6.5(a)(1) and Section 6.5(a)(2), from time to time after License Option Exercise, to the extent not done so already, MacroGenics shall, and shall cause its Affiliates to, without additional compensation, disclose and make available to Takeda, in whatever form Takeda may reasonably request, as soon as reasonably practicable after the earlier of the development, making, conception or reduction to practice, all Regulatory Documentation and other Information Controlled by MacroGenics, which in each case is reasonably necessary or useful for Takeda’s Exploitation of the Compounds and the Products, including copies or tangible embodiments thereof. For clarity, MacroGenics will have the right, unless otherwise required by Applicable Law, to retain original copies of the foregoing.

Initial Data Transfer. (1a) Within sixty (60) days [***] after License Option Exercisethe Development Transition Date, MacroGenics shall deliver to Takeda Company electronic copies (unless otherwise required by Applicable Law) of all Regulatory Materials relating to the Products in the Field in the Territory which are owned or Controlled by MacroGenics. Promptly after Upon the completion of such transfer, but MacroGenics shall, and hereby does, assign to Company all such Regulatory Materials and shall promptly (and in any case within ten (10) Business Days, MacroGenics shall [***] take all steps reasonably necessary to assign effectuate the assignment of all INDs, Regulatory Approval Applications and Regulatory Approvals to Takedaincluded in such Regulatory Materials, including submitting to any applicable Regulatory Authority a letter or other necessary documentation (with copy to TakedaCompany) notifying the Regulatory Authority of the assignment. In the event that any such IND, Regulatory Approval Application or Regulatory Approval cannot be transferred within such [***] period, MacroGenics shall take all actions reasonably requested by Company with respect to the maintenance or transfer of such IND, Regulatory Approval Application or Regulatory Approval. (2b) Within ninety (90) days [***] after License Option Exercisethe Development Transition Date, MacroGenics shall make available to Takeda Company separate electronic copies of all remaining Regulatory Documentation, including the study reports from all non-clinical trials and clinical trials, in each case, whether completed prior to the exercise of the License Option Development Transition Date or then in-progress, that are owned or Controlled by MacroGenics (to the extent not previously provided to TakedaCompany). (3c) Notwithstanding Section 6.5(a)(15.1(a) and Section 6.5(a)(25.1(b), from time to time after License Option Exercisethe Development Transition Date, to the extent not done so already, MacroGenics shall, and shall cause its Affiliates to, without additional compensation, disclose and make available to TakedaCompany, in whatever form Takeda Company may reasonably request, as soon as reasonably practicable after the earlier of the development, making, conception or reduction to practice, all Regulatory Documentation and other Information Controlled by MacroGenics, which in each case is reasonably necessary or useful for TakedaCompany’s Exploitation of the Compounds and the Products, including copies or tangible embodiments thereof. For clarity, MacroGenics will have the right, unless otherwise required by Applicable Law, to retain original copies of the foregoingforegoing subject to ARTICLE 12.

Initial Data Transfer. (1a) Within sixty (60) days [***] after License Option Exercisethe Development Transition Date, MacroGenics shall deliver to Takeda Company electronic copies (unless otherwise required by Applicable Law) of all Regulatory Materials relating to the Products in the Field in the Territory which are owned or Controlled by MacroGenics. Promptly after Upon the completion of such transfer, but MacroGenics shall, and hereby does, assign to Company all such Regulatory Materials and shall promptly (and in any case within ten (10) Business Days, MacroGenics shall [***] take all steps reasonably necessary to assign effectuate the assignment of all INDs, Regulatory Approval Applications and Regulatory Approvals to Takedaincluded in such Regulatory Materials, including submitting to any applicable Regulatory Authority a letter or other necessary documentation (with copy to TakedaCompany) notifying the Regulatory Authority of the assignment. In the event that any such IND, Regulatory Approval Application or Regulatory Approval cannot be transferred within such [***] period, MacroGenics shall take all actions reasonably requested by Company with respect to the maintenance or transfer of such IND, Regulatory Approval Application or Regulatory Approval. (2b) Within ninety (90) days [***]after License Option Exercisethe Development Transition Date, MacroGenics shall make available to Takeda Company separate electronic copies of all remaining Regulatory Documentation, including the study reports from all non-clinical trials and clinical trials, in each case, whether completed prior to the exercise of the License Option Development Transition Date or then in-progress, that are owned or Controlled by MacroGenics (to the extent not previously provided to TakedaCompany). (3c) Notwithstanding Section 6.5(a)(15.1(a) and Section 6.5(a)(25.1(b), from time to time after License Option Exercisethe Development Transition Date, to the extent not done so already, MacroGenics shall, and shall cause its Affiliates to, without additional compensation, disclose and make available to TakedaCompany, in whatever form Takeda Company may reasonably request, as soon as reasonably practicable after the earlier of the development, making, conception or reduction to practice, all Regulatory Documentation and other Information Controlled by MacroGenics, which in each case is reasonably necessary or useful for Takeda’s Company's Exploitation of the Compounds and the Products, including copies or tangible embodiments thereof. For clarity, MacroGenics will have the right, unless otherwise required by Applicable Law, to retain original copies of the foregoingforegoing subject to ARTICLE 12.