Device Program Plans Clause Samples

Device Program Plans. (i) The Parties agree that, as of the Effective Date, the Development Plan for the Therapeutic Product will include Development activities [****]. From time to time, during the Term, each Party shall have the right to propose to the JDC that the Development Plan be amended to include a device, [****], for administration of any Product for use in the Field (each such device, an “Administration Device”) in the Co-Commercialization Territory or in the Roche Territory by submitting a written proposal to the JDC describing the proposed Administration Device and anticipated costs and timelines with respect thereto, in sufficient detail for such Party to consider for inclusion in the Development Plan (each such proposal, a “Device Program Plan”). (ii) Following a Party’s submission of a Device Program Plan to the JDC in accordance with Section 3.5(c)(i), the JDC shall, at its next regularly scheduled meeting, review and determine whether to modify or amend such Device Program Plan. In the event that the JDC accepts such Device Program Plan (as modified or amended, as applicable), then the JDC shall recommend such Device Program Plan for consideration by the JSC for inclusion in the Development Plan (with any modifications or amendments agreed upon by the JDC) by providing the JSC with such Device Program Plan. Following the JDC’s submission of a Device Program Plan to the JSC in accordance with this Section 3.5(c)(ii), the JSC shall, at its next regularly scheduled meeting, review and determine whether to approve such Device Program Plan, either in the form provided by the JDC or with such modifications or amendments agreed upon by the JSC. If the JSC approves such Device Program Plan (with any modifications or amendments agreed upon by the JSC), such Device Program Plan shall be incorporated in the Development Plan. If the JSC fails to approve the Device Program Plan in accordance with Section 2.5, then (1) for the Co-Commercialization Territory, neither Party may, directly or indirectly, itself or through any Affiliate or Third Party, Develop or Commercialize the applicable Administration Device for the Co-Commercialization Territory and (2) for the Roche Territory, Roche may, at its sole cost and expense, Develop the applicable Administration Device for the administration of a Product Developed for use in the Field pursuant to the Development Plan for use solely in the Roche Territory.