Development Diligence. Following the Collaboration Period, Pfizer will use Commercially Reasonable Efforts to Develop and seek Regulatory Approval for at least [**] in at least one indication in [**], at its own cost. No later than [**] days following the EOP2 Meeting with the FDA and EMA, Pfizer shall provide Spark with [**] (the “Pivotal Trial Development Plan”), [**]. Without limiting its obligations in the first sentence of this Section 4.9.1 and its rights under Section 4.9.4, Pfizer will use its Commercially Reasonable Efforts to conduct the Pivotal Trial Development Plan [**] thereunder, it being understood that [**] within the control of Pfizer may [**] outlined in the Pivotal Trial Development Plan. Pfizer may [**] the Pivotal Trial Development Plan [**], provided that any such [**] with Pfizer’s exercise of its required Commercially Reasonable Efforts, and shall promptly provide to Spark with such [**] Pivotal Trial Development Plan. Except as outlined above or as otherwise set forth in this Agreement, Pfizer will have no other diligence obligations with respect to the Development or Regulatory Approval of Licensed Products under this Agreement. Pfizer shall ensure that the Pivotal Trial Development Plan and [**] submitted to Spark shall be the same as or substantially consistent with the corresponding plan used by Pfizer for internal planning and management purposes.
Appears in 3 contracts
Sources: License Agreement, License Agreement (Spark Therapeutics, Inc.), License Agreement (Spark Therapeutics, Inc.)