Transferred Regulatory Materials definition

Transferred Regulatory Materials has the meaning set forth in Section 2.1(a).

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Transferred Regulatory Materials has the meaning set forth in Section 3.3(a)(iv).

Transferred Regulatory Materials has the meaning set forth in Section 4.9(a).

Examples of Transferred Regulatory Materials in a sentence

Unless otherwise required by Applicable Law, from and after such assignment and transfer, Novartis (or its designee) shall have the sole right, in its sole discretion, to file, maintain, and hold title to all Transferred Regulatory Materials.
To the extent permissible under Applicable Laws, MKDG shall assign to C4T, and shall provide C4T with a right of reference with respect to, such requested Transferred Regulatory Materials, as C4T determines at its reasonable discretion, at C4T’s sole cost and expense.
The Parties shall cooperate to enable Buyer to prepare and submit all appropriate and necessary documentation to transfer to Buyer all other Transferred Regulatory Materials.
Unless otherwise required by Applicable Law, from and after such assignment and transfer, Pharmavant (or its designee) shall have the sole right, [***], to (i) conduct the Eisai Ongoing Clinical Trial in accordance with the Development Plan and (ii) file, maintain, and hold title to all Transferred Regulatory Materials in accordance with the Development Plan and the Commercialization Plan.
Upon Takeda’s reasonable request, TBIL shall transfer to Takeda all data, information and other materials underlying or supporting such Transferred Regulatory Materials with respect to each Product.
Unless otherwise agreed to by the Parties, after TBIL completes transfer to Takeda of the Transferred Regulatory Materials with respect to the Products, Takeda shall own, and hold in its name, the IND and all other Regulatory Materials (including all Regulatory Approvals) for such Products with respect to the Field within the Territory.
ImmunityBio grants to HCW a right of reference to the Transferred Regulatory Materials solely in connection with HCW’s Exploitation of HCW9218 in the Licensed Field.
To the extent permissible under Applicable Law and commercially feasible, Pfizer shall transfer ownership to or assign to Theravance and shall provide Theravance with a right of reference with respect to such Transferred Regulatory Materials, as Theravance determines at its reasonable discretion, [*****].
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.

More Definitions of Transferred Regulatory Materials

Transferred Regulatory Materials means all U.S. and foreign regulatory applications, submissions and approvals (including all INDs and Drug Approval Applications and foreign counterparts thereof), and all Regulatory Approvals for TGFb Molecules, and all correspondence with the FDA and other Regulatory Agencies relating to the TGFb Molecules or any of the foregoing regulatory applications, submission and approvals, that, in each case, are in the possession of or Controlled by, or held by Respondents or any of their Affiliates as of the Effective Date, whether generated, filed or held by or for Respondents or any of their Affiliates or licensees. aaa.

Transferred Regulatory Materials has the meaning set forth in Section 3.3(a)(iv). “Transferred Third Party Agreements” means those Third Party Agreements that are primarily related to Binimetinib. “Transferred Trademarks” means those trademarks and trademark applications, and any resulting trademark registrations, related to the marks set forth on Schedule 1.1(d), including all goodwill arising therefrom. “Transition Agreement” means the transition services agreement to be executed and delivered by Array and Novartis on the Effective Date, substantially in the form mutually agreed upon by the Parties. “Transition Committee” or “TC” has the meaning set forth in Section 3.10(a). “Upfront Payment” has the meaning set forth in Section 5.4(a).