Joint Development Committees. For each Development Candidate, the CSC will appoint a joint development committee (each, a “Neurology JDC”) approximately [***] days prior to the date Ionis expects to designate a Development Candidate, to govern the activities under this Agreement with respect to such Collaboration Program. Each Neurology JDC will report to the CSC and will consist of an equal number of representatives appointed by ▇▇▇▇▇ and Biogen. Each Neurology JDC member will be a senior clinical development leader or have other experience and expertise appropriate for the stage of development of the Collaboration Program in the applicable disease area, and at least one of each Party’s members will have operational responsibility for the applicable Collaboration Program. Each Party will designate one of its representatives who is empowered by such Party to make decisions related to the performance of such Party’s obligations under this Agreement to act as the co-chair of the Neurology JDC. The co-chairs will be responsible for overseeing the activities of the Neurology JDC consistent with the responsibilities set forth below in this Section 1.18.3. Schedule 1.18.3 sets forth certain Neurology JDC governance matters agreed to as of the Effective Date. Each Neurology JDC will determine its operating procedures at its first meeting, including the Neurology JDC’s policies for replacement of Neurology JDC members, policies for participation by additional representatives or consultants invited to attend Neurology JDC meetings, and the location of meetings, which will be codified in the written minutes of the first Neurology JDC meeting. Each Party will be responsible for the costs and expenses of its own employees or consultants attending Neurology JDC meetings. If practical, Ionis and Biogen will use reasonable efforts to schedule meetings of each Neurology JDC to take place at the same location and on the same dates as meetings of the CSC and the joint development and steering committees under the Ionis/Biogen Additional Agreements, to maximize the use of each Party’s time, increase information sharing efficiencies and reduce the cost of additional travel, lodging and related expenses. Confidential
Appears in 1 contract
Joint Development Committees. For each Development CandidatePrior to the Initiation of the Phase 2 GA Trial and the Phase 2 [***] Trial, as applicable, the CSC Parties will appoint establish a joint development committee (each, a “Neurology JDC”) approximately for the Phase 2 GA Trial and a separate JDC for the Phase 2 [***] Trial. Thereafter, if the Parties agree that Ionis will conduct any other Phase 2 Trial under the Development Plan, within thirty (30) days prior to after such agreement, the date Ionis expects to designate Parties will establish a Development Candidate, to govern the activities under this Agreement with respect to separate JDC for such Collaboration ProgramPhase 2 Trial. Each Neurology JDC will report to the CSC and will consist of an equal number of representatives appointed by ▇▇▇▇▇ Ionis and Biogen. Each Neurology JDC member will be a senior clinical development leader or have other experience and expertise appropriate for the stage of development of the Collaboration Program in the applicable disease area, and at least one of each Party’s members will have operational responsibility for the applicable Collaboration Program. Each Party will designate one of its representatives who is empowered by such Party to make decisions related to the performance of such Party’s obligations under this Agreement to act as the co-chair of the Neurology JDC. The co-chairs will be responsible for overseeing the activities of the Neurology JDC consistent with the responsibilities set forth below in this Section 1.18.3. Schedule 1.18.3 sets forth certain Neurology JDC governance matters agreed to as of the Effective Date. Each Neurology JDC will determine its operating procedures at its first meeting, including the Neurology JDC’s policies for replacement of Neurology JDC members, policies for participation by additional representatives or consultants invited to attend Neurology JDC meetings, and the location of meetings, which will be codified in the written minutes of the first Neurology JDC meetingRoche. Each Party will be responsible for the costs and expenses of its own employees or consultants attending Neurology JDC meetings. Ionis will have the right, but not the obligation, to participate in each JDC after Option exercise. If practicalIonis chooses not to participate, Ionis and Biogen then Roche can dissolve the JDC. Each JDC will use reasonable efforts to schedule meetings of each Neurology JDC to take place at be dissolved as soon as reasonably possible after the same location and on the same dates as meetings Completion of the CSC and applicable ongoing Phase 2 Trial over which such JDC has oversight.
(a) Role of the joint development and steering committees JDCs. Without limiting any of the foregoing, subject to Section 4.1.2(b), the applicable JDC will perform the following functions, some or all of which may be addressed directly at any given JDC meeting: (i) oversee the Parties’ activities regarding the applicable Phase 2 Trial under the Ionis/Biogen Additional AgreementsDevelopment Plan; (ii) oversee the formation and operation of any subcommittee of the JDC regarding the applicable Phase 2 Trial under the Development Plan; (iii) with respect to the JDC for the Phase 2 [***] Trial (or the JDC for any subsequent Phase 2 Trial that the Parties agree Ionis will conduct), discuss and agree upon the proposed design and protocol(s) for the Phase 2 [***] Trial (or other Phase 2 Trial, if applicable) under the Development Plan and present such documents to maximize the use of each Party’s time, increase information sharing efficiencies JSC for final approval; and reduce (iv) such other review and advisory responsibilities as may be assigned to the cost of additional travel, lodging and related expenses. Confidentialapplicable JDC by the Parties pursuant to this Agreement.
Appears in 1 contract
Sources: Factor B Development Collaboration, Option and License Agreement (Ionis Pharmaceuticals Inc)