Additional Licensor Development Activities Clause Samples

Additional Licensor Development Activities. 3.3.1 If Licensor proposes to the JDC an amendment to a Development Plan and Budget to include Development activities designed to support the filing of Drug Approval Applications and the obtaining of Regulatory Approvals for a Licensed Product in an Additional Indication not covered by a Post Exercise Development Plan and Budget, then any such proposed amendment shall include with such proposal the detailed activities to be conducted and the associated budget. If the JDC declines, within [***] of receipt of the proposal to amend the applicable Development Plan and Budget to include such activities, then, subject to the remainder of this Section 3.3 and the other applicable terms of this Agreement, Licensor may conduct such activities (the “Additional Licensor Development Activities”) at its own expense and such costs and expenses shall not be shared by the Parties (except as expressly provided in Section 3.3.4); provided that, prior to Licensor commencing such activities, the Parties must agree upon adjustments to the terms of this Agreement to address the potential splitting of the Field (e.g., with respect to regulatory matters, differentiation of products, reporting, etc.). In addition, unless otherwise approved by AbbVie, Licensor shall not Conduct any Phase III Clinical Study, or file a BLA with respect to a Licensed Antibody or Licensed Product for an Additional Indication, prior to the Option Exercise Date for the applicable Collaboration Program. 3.3.2 Prior to AbbVie’s exercise of its Option for both Collaboration Programs, Licensor may conduct Clinical Studies within the Additional Licensor Development Activities only using an Antibody set forth on Schedule 3.3.2 and no other Licensed Antibody. After AbbVie’s exercise of its Option for both Collaboration Programs, Licensor may conduct Additional Development Activities with any Licensed Antibodies that are not included in a Post Exercise Development Plan and Budget or being Developed or Commercialized by AbbVie in performing such Additional Development Activities (i.e., Licensor may not use in any Clinical Study the lead Antibody or any backups in either Collaboration Program). *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. 3.3.3 If, at any time, AbbVie believes that an Additional Licensor Development Activity would adverse...