Common use of Additional Licensor Development Activities Clause in Contracts

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 adversely affect a Licensed Antibody or Licensed Product included in a Development Plan and Budget or being Developed or Commercialized by AbbVie or its commercial prospects, AbbVie may notify Licensor and Licensor will not undertake such activity and cease any such activity that has already commenced. If Licensor disputes AbbVie’s belief that such Additional Licensor Development Activity would cause such an adverse effect, Licensor may seek to resolve such dispute through expert arbitration pursuant to Section 13.7.4 (provided that Licensor shall not undertake such activity unless and until it is determined through such arbitration that there will be no such adverse effect). 3.3.4 For each Additional Indication pursued under an Additional Licensor Development Activity, if AbbVie has exercised the Option in accordance with Section 5.1.1 with respect to the applicable Collaboration Program, AbbVie shall have the right (the “AbbVie Opt In”), exercisable by written notice to Licensor at [***] to assume control of the Additional Licensor Development Activity and the Licensed Antibody with respect to such Additional Indication (the date such AbbVie Opt In notice is delivered, the “AbbVie Opt In Exercise Date”). If AbbVie exercises the AbbVie Opt In, (a) AbbVie shall [***], and (c) thereafter, such product shall be deemed a “Licensed Product” for all purposes under this Agreement. If AbbVie does not exercise the AbbVie Opt In with respect to such Additional Indication prior to the deadline above, Licensor may independently develop and commercialize such Licensed Antibody for such Additional Indication, subject to Section 3.3.2 and the terms of the agreement negotiated between the Parties pursuant to Section 3.3.1. For clarity, if AbbVie does not exercise the AbbVie Opt In with respect to a given Indication, AbbVie retains all rights with respect to the applicable Licensed Antibody for all other Indications.