Common use of Limitations on Decision-Making Authority Clause in Contracts

Limitations on Decision-Making Authority. The foregoing provisions of Section 4.4.2 notwithstanding, neither Party shall have the right to exercise its final decision-making authority to unilaterally: (i) determine that it has fulfilled any obligations under this Agreement or that the other Party has breached any obligation under this Agreement; (ii) determine that milestone events required for the payment of milestone payments have or have not occurred; (iii) make a decision that is expressly stated to require the mutual agreement of the Parties; (iv) amend any Development Plan to require the Development of any Compound other than the Development Candidate for which clinical Development was first conducted in such Development Program; (v) change or modify the Hit Criteria, Lead Candidate Criteria or Development Candidate Selection Criteria; (vi) subject to Section 6.6, decide to pursue a Pivotal Clinical Trial that does not satisfy regulatory requirements in both the United States and Europe; (vii) require or restrict the other Party from conducting Development activities specifically related only to such Party’s territory, except as otherwise set forth herein; or (viii) otherwise expand its rights or reduce its obligations under this Agreement.

Limitations on Decision-Making Authority. The foregoing provisions of Section 4.4.2 notwithstanding, neither Party shall have the right to exercise its final decision-making authority to unilaterally: (i) determine that it has fulfilled any obligations under this Agreement or that the other Party has breached any obligation under this Agreement; (ii) determine that milestone events required for the payment of milestone payments have or have not occurred; (iii) make a decision that is expressly stated to require the mutual agreement of the Parties; (iv) amend any Development Plan to require the Development of any Compound other than the Development Candidate for which clinical Development was first conducted in such Development Program; (v) change or modify the Hit Criteria, Lead Candidate Criteria or Development Candidate Selection Criteria; (vi) subject to Section 6.66.4, decide to pursue a Pivotal Clinical Trial with respect to a Shared Development Program that does not satisfy regulatory requirements in both the United States and Europe; (vii) require or restrict the other Party from conducting Development activities specifically related only to such Party’s territory, except as otherwise set forth herein; (viii) amend the Research Plan; or (viiiix) otherwise expand its rights or reduce its obligations under this Agreement.