Roche Diligence. 5.2.1. In the event and to the extent that ROCHE has exercised an option right under this Agreement, ROCHE will use and will cause its Affiliates, sub-licensees and marketing partners (if any) to use Commercially Reasonable Efforts to proceed with the development, manufacture, marketing, distribution and sale of the Product. *Portions of this document marked with **** have been omitted pursuant to a request for confidential treatment submitted with the SEC.
Roche Diligence. After Option exercise, subject to the terms of this Agreement, Roche is solely responsible for all Development, Manufacturing and Commercialization activities, and for all costs and expenses associated therewith, with respect to the Development, Manufacture and Commercialization of Products. Roche will use Commercially Reasonable Efforts to Develop, Manufacture and Commercialize Products, including to meet the timelines and milestones set forth in the Isis Development Candidate-R&D Plan, the IDCP and the Specific Performance Milestone Events. Prior to Initiation of the first Registration-Directed Trial for a given Product, Roche will prepare a Development and global integrated development and commercialization plan (“IDCP”) outlining key aspects for Developing such Product through Approval, and Roche’s worldwide strategy to launch and Commercialize such Product. The IDCP will incorporate and replace the applicable R&D Plan and will take the form of, and contain information consistent with, Roche’s Development and Commercialization plans for its similar products at similar stages of development or commercialization, including Product Sales forecasts. Once Roche has prepared such plan, Roche will update the IDCP consistent with Roche’s standard practice and provide such updates to Isis at least Annually.
Roche Diligence. Following the Effective Date, Roche shall use Reasonable Diligence in proceeding with the manufacturing, marketing and sale of Daclizumab for use in the Transplant Indications in the Territory as contemplated by this Amended and Restated Worldwide Agreement, and in a manner comparable to its conduct of the manufacturing, marketing and sale of Daclizumab [*] during the [*] prior to the Effective Date. If Roche fails to exercise such diligence, PDL may exercise its rights hereunder pursuant to Section 13.3 below, but shall not be obligated to do so. Roche’s diligence obligations under this Section 4.6 shall expire on, (i) if PDL exercises the Transplant Reversion or Roche exercises the Roche Put Right, the completion of all activities and undertakings set forth in Sections 5.4(b), (c), (e) and (f), or (ii) if the Exercise Period expires without PDL exercising the Transplant Reversion. In the event of a dispute as to whether Roche has used Reasonable Diligence, the party that loses on this issue in an arbitration brought pursuant to Article XV shall reimburse all of the other party’s arbitration expenses, including reasonable attorneys’ fees relating to such arbitration.
Roche Diligence. Following the Effective Date, Roche shall use Reasonable Diligence in proceeding with the manufacturing, marketing and sale of Daclizumab for use in the Transplant Indications in the Territory as contemplated by this Amended and Restated Worldwide Agreement, and in a manner comparable to its conduct of the manufacturing, marketing and sale of Daclizumab [CONFIDENTIAL TREATMENT REQUESTED] during the [CONFIDENTIAL TREATMENT REQUESTED] prior to the Effective Date. If Roche fails to exercise such diligence, PDL may exercise its rights hereunder pursuant to Section 13.3 below, but shall not be obligated to do so. Roche’s diligence obligations under this Section 4.6 shall expire on, (i) if PDL exercises the Transplant Reversion or Roche exercises the Roche Put Right, the completion of all activities and undertakings set forth in Sections 5.4(b), (c), (e) and (f), or (ii) if the Exercise Period expires without PDL exercising the Transplant Reversion. In the event of a dispute as to whether Roche has used Reasonable Diligence, the party that loses on this issue in an arbitration brought pursuant to Article XV shall reimburse all of the other party’s arbitration expenses, including reasonable attorneys’ fees relating to such arbitration.
Roche Diligence. After Option exercise, subject to the terms of this Agreement, Roche is solely responsible for all Development, Manufacturing and Commercialization activities, and for all costs and expenses associated therewith, with respect to the Development, Manufacture and Commercialization of the Products, except with respect to any Phase 2 Trial being conducted by Ionis under the Development Plan that has not yet Completed by the time of Option exercise, which will remain the responsibility of Ionis until such Phase 2 Trial has Completed. Roche will use Commercially Reasonable Efforts to Develop, Manufacture and Commercialize Products, including to meet the timelines and milestones set forth in the Development Plan, the IDCP and the Specific Performance Milestone Events. 8.1.1.
