Common use of Exceptions to Diligence Obligations Clause in Contracts

Exceptions to Diligence Obligations. Notwithstanding any provisions of this Agreement to the contrary, Pfizer will not be deemed in breach of its Diligence Obligations to the extent that: (a) Pfizer or Spark receives or generates any safety, tolerability or other data indicating or signaling that a Licensed Product has or would have an unacceptable risk-benefit profile or is otherwise not reasonably suited for initiation or continuation of Clinical Trials; or (b) Pfizer or Spark receives any notice, information or correspondence from any applicable Regulatory Authority or any applicable Regulatory Authority takes any action that reasonably indicates that a Licensed Product is unlikely to receive Regulatory Approval or Regulatory Exclusivity; or (c) if (i) Pfizer intends to Manufacture Compound or Licensed Products for Phase III Clinical Development and/or Commercialization under Section 4.12, and either (A) the Parties cannot agree upon a technology transfer plan pursuant to Section 4.5.3, or (B) Spark fails to complete a transfer of the Manufacture process technology to Pfizer, or (ii) the Parties have mutually agreed to have Spark Manufacture for the Phase III Clinical Trials and/or Commercialization of Licensed Products and Spark fails to deliver the Compounds or Licensed Products pursuant to such the negotiated supply agreement; provided that, in the case of either (a), (b) or (c)(i)(A), Pfizer shall continue to take such steps, if any, as are consistent with the exercise of Commercially Reasonable Efforts in view of such circumstances. In the event of any of the foregoing, Pfizer may take any and all actions it deems necessary or appropriate in its reasonable discretion with respect to Development activities or clinical studies to appropriately address such concerns, including instituting a clinical hold or otherwise suspending Development, terminating some or all Development activities or clinical studies with respect to a particular Compound or Licensed Product or terminating this Agreement in its entirety or with respect to such Compound or Licensed Product pursuant to Section 8.3.