Exceptions to Diligence Obligations. Notwithstanding any provisions of this Agreement to the contrary: (a) if Pfizer, an Affiliate or sublicensee of Pfizer, OPKO or a Third Party generates any safety, tolerability or other data reasonably indicating, as measured by Pfizer’s safety and efficacy evaluation criteria and methodology, or signaling that a Licensed Product has or would have an unacceptable risk-benefit profile, Pfizer may take any and all actions it deems necessary or appropriate in its sole discretion to appropriately address such concerns, including putting on hold or ceasing Development and/or Commercialization of any effected Compound or Licensed Product, or terminating this Agreement in its entirety; and (b) in such event, Pfizer shall not be in breach of this Agreement or any obligation hereunder as a result of Pfizer taking such actions so long as Pfizer is using Commercially Reasonable Efforts to address and, to the extent practicable, remedy the safety issue in order to permit continued Commercialization.
Appears in 2 contracts
Sources: Development and Commercialization License Agreement, Development and Commercialization License Agreement (Opko Health, Inc.)
Exceptions to Diligence Obligations. Notwithstanding any provisions of this Agreement to the contrary: (a) if Pfizer, an Affiliate or sublicensee of Pfizer, OPKO or a Third Party generates any safety, tolerability or other data reasonably indicating, as measured by Pfizer’s safety and efficacy evaluation criteria and methodology, or signaling that a Licensed Product has or would have an unacceptable risk-benefit profile, Pfizer may take any and all actions it deems necessary or appropriate in its sole discretion to appropriately address such concerns, including putting on hold or ceasing Development and/or or Commercialization of any effected Compound or Licensed Product, or terminating this Agreement in its entirety; and (b) in such event, Pfizer shall not be in breach of this Agreement or any obligation hereunder as a result of Pfizer taking such actions so long as Pfizer is using Commercially Reasonable Efforts to address and, to the extent practicable, remedy the safety issue in order to permit continued Commercialization.
Appears in 1 contract
Sources: Development and Commercialization License Agreement (Opko Health, Inc.)