No Change; Status Quo. If the Executive Officers are unable to reach agreement on any such matter referred to them within [***] after such matter is so referred (or such longer period as the Executive Officers may agree upon), then neither Party will have final decision-making authority over approval of such matter and all such matters must be decided by unanimous agreement of the Parties in order to take any action or adopt any change from the then-current status quo, as applicable, provided that TGTX will have final decision-making authority with respect to [***].
No Change; Status Quo. Neither Party will have final decision-making authority over (i) [***], or (ii) [***] (each, a “Status Quo Item”), and all such matters must be decided by unanimous agreement in order to take any action or adopt any change from the then-current status quo.
No Change; Status Quo. Neither Party will have final decision-making authority over with respect to the final resolution of any other disagreement regarding a matter delegated under this Agreement to the JSC for decision, including approval of: [***].
No Change; Status Quo. Neither Party will have final decision-making authority over [***] and all such matters must be decided by unanimous agreement in order to take any action or adopt any change from the then-current status quo. (c) Licensee Final Decision-Making Authority. For the avoidance of doubt, while not within the decision-making authority of the JSC, Licensee will have final decision- making authority over matters [***]. 3.5.3
No Change; Status Quo. Neither Party will have final decision-making authority over the following matters, and all such matters must be decided by unanimous agreement in order to take any action or adopt any change from the then-current status quo: (i) any change or update to the Global Development Plan or Global Development Budget, (ii) adoption of, or any change or update to, the Global Branding Strategy, (iii) adoption of, or any change or update to, the Medical Affairs Strategy, or (iv) the approval or coordination of or any change or update to the Apellis Readiness Activities.
No Change; Status Quo. Neither Party will have final decision-making authority with respect to the final resolution of any disagreement related to: (i) [***]; (ii) [***]; (iii) [***]; (iv) [***]; (v) [***]; and (vi) [***].
No Change; Status Quo. Neither Party will have final decision-making authority over [**] must be decided by unanimous agreement of the Parties.
No Change; Status Quo. Neither Party will have final decision-making authority over (i) any matter reasonably likely to give rise to any safety concerns with respect to the Licensed Product, (ii) the conduct of any uniQure Additional Development Activities, (iii) any update with respect to uniQure’s activities under the Current Phase III Protocol or Current Phase III Budget, or (iv) the initial uniQure Additional Development Plan or the uniQure Additional Development Budget or any update thereto; provided that with respect to each of clauses (ii), (iii), and (iv) above, if a Regulatory Authority requires or requests a change to uniQure Development Activities (including under the Current Phase III Protocol), then Partner will have final decision-making authority in respect of, and will have the right to require such change, if Partner agrees to a corresponding increase to the uniQure Development Budget if such change is made.
No Change; Status Quo. Neither Party will have final decision-making authority with respect to any Committee Deadlocks regarding [***], which will require agreement of the Parties to make any change from the then-current status quo.
No Change; Status Quo. Neither Party will have final decision-making authority (i) over the allocation to CStone of any Development activities set forth in the Global Development Plan to be conducted by CStone outside of the Territory, (ii) over the following Territory-specific Development activities that are to be conducted by CStone under a Global Development Plan in the Territory: selection of Clinical Trial sites, principal investigators, CROs in the Territory, and compliance with any requirements of a Regulatory Authority to the extent necessary to obtain Regulatory Approval in the Territory from such Regulatory Authority, (iii) to require CStone to serve as the Territory Sponsor or regulatory agent of any Global Clinical Trial for a Collaboration Product for a New Indication, (iv) as to whether to conduct further Development of the BLU-554/CStone Checkpoint Combination or the BLU-554/Other Checkpoint Combination as a first line therapy for the HCC Indication under BLU-554 Scenario 1 or BLU-554 Scenario 2, respectively, (v) as to whether to approve any Combination Regimen that includes a Proposed Additional Blueprint/CStone Combination (or any other Combination Regimen that includes the CStone Checkpoint Antibody other than the BLU-554/CStone Checkpoint Combination) as a Blueprint/CStone Combination under this Agreement, (vi) over the Manufacturing Technology Transfer Plan or the scope of Manufacturing activities that will be conducted by CStone, (vii) over the Development of Companion Diagnostics by CStone for use in connection with the Commercialization of any Collaboration Product in the Territory, (viii) over whether to extend the period during which Blueprint will supply to CStone any [***] Blueprint Products beyond [***] for such Blueprint Product, (ix) over any brand strategy for a Collaboration Product that is specific to the Territory (or any region therein) and that is inconsistent with the Global Brand Strategy for such Collaboration Product, (x) over any changes to then-current FTE Rates for a Party, (xii) as to whether to approve any Subcontractor as a Preapproved Subcontractor for purposes of this Agreement, or (xii) the CStone New Indication Share with respect to a New Indication for a Collaboration Product, and all such matters set forth in the foregoing clauses ((i) through (xii)) must be decided by unanimous agreement of the Parties in order to take any action or adopt any change from the then-current status quo.
