Examples of Additional Development Activities in a sentence
If the JSC approves an Additional Development Proposal, the Development Plan shall be deemed to be amended to include the Additional Development Activities and associated budget upon approval of such Additional Development Proposal by the JSC.
The PSC shall vote on whether to approve an Additional Development Proposal within [***] after receipt thereof from the Proposing Party as set forth in this Section 5.2.5.2 (PSC Decision Regarding Additional Development Activities).
The Proposing Party shall also provide the JPT with any other Information related to the Additional Development Activities which is reasonably requested by the JPT and available to the Proposing Party.
Additional Development Activities are “Successful” if such activities (1) produce data or results that satisfy the relevant endpoints, in the case of a clinical trial, (2) otherwise achieve the desired goals of such Additional Development Activities that are specified by Jazz in writing before it initiates such activities, or (3) produce data that is incorporated into an approved label or result in a compendia listing.
Subject to any Supply Agreement, any Losses arising out of Third Party product liability claims arising from the Development of Regional Licensed Products will be treated as Development Costs in accordance with Section 5.2.4; provided that (x) with respect to any Additional Development Activities, the CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.
For clarity, a Licensed Product that is the subject of Additional Development Activities shall continue to be a “Licensed Product” for all purposes of this Agreement.
Product Candidates will be Developed in the Territory and in North America pursuant to a Global Development Plan and in connection with any Additional Development Activities that may be undertaken by either Party.
To the extent not provided pursuant to Section 4.3.1, the JPT shall establish a process pursuant to which each Party shall promptly provide to the other Party copies of or access to non-clinical data and Clinical Data, and other Information, results, and analyses with respect to any Development activities for a Collaboration Program and its Additional Development Activities (collectively, “Regulatory Data”).
Lyell and GSK will each provide an update at each JSC meeting detailing the current status of each Lyell Development Program or Development Program, as applicable, and in the case of Lyell, Additional Development Activities, including in each case a summary in reasonable detail of the Collaboration Programs and the Additional Development Activities (as applicable), results obtained therein and future plans with respect thereto.
Lyell shall keep GSK reasonably informed of its or its academic partner’s interactions with Regulatory Authorities regarding Regulatory Materials for Lyell PoC Development Programs and Additional Development Activities, to the extent such interactions reasonably relate to a Compound or Product.