Basilea’s Ongoing Phase 3 Program Clause Samples

Basilea’s Ongoing Phase 3 Program. As of the Effective Date, Basilea is planning a Phase 3 clinical program in SAB and ABSSSI, and potentially at a later date in CAP with the goal of a registration in the United States. Such studies could, if successful, enable an application for a label extension in the Territory for SAB and/or ABSSSI. The following shall apply with respect to this Phase 3 clinical program: (a) Basilea shall be solely responsible to conduct and bear the costs for this phase 3 clinical program, and shall conduct such program in its sole discretion, including making any decision to cease conducting such program; (b) All data and knowledge produced from the Phase 3 clinical program shall be considered Know-How under this Distribution Agreement and therefore is licensed to Cardiome with no further compensation other than as specified in this Distribution Agreement. For the avoidance of doubt, the milestone in Section 8.2(b) shall be due in the event that the Product is approved with an indication for SAB in the countries specified in such Section; (c) Basilea will inform Cardiome of the identity of the hospitals and investigators in the Territory with whom it plans to conduct any such clinical studies; (d) Basilea will discuss with Cardiome through the JSC the outcome of the Phase 3 program and its plan to update the core harmonized Dossier for the Product as soon as reasonably possible upon completion of the studies, and Cardiome shall thereafter update the Commercial Launch Plan and/or the Commercialization Plan. The Parties shall thereafter cooperate to make such Submissions (pursuant to Section 4.4) as necessary to update the Dossier, in accordance with Article 4.1(b) and 4.2. Confidential/Basilea Pharmaceutica International Ltd. & Correvio International Sàrl page 22 of 80