Exceptions to Diligence Obligations. Notwithstanding any provision of this Agreement to the contrary, Pfizer will be relieved from and will have no obligation to undertake any efforts with respect to any diligence obligation under Section 3.2.1 or Section 3.2.2 with respect to a given Agreement PDC or Licensed Product (each, a “Pfizer Diligence Obligation”) in the event that:
(a) Pfizer or CytomX receives or generates any safety, tolerability or other data reasonably indicating or signaling, as measured by Pfizer’s safety and efficacy evaluation criteria and methodology, that an Agreement PDC or a Licensed Product has or would have an unacceptable risk-benefit profile or is otherwise not reasonably suitable for initiation or continuation of clinical trials in humans;
(b) Pfizer or CytomX receive 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
(c) CytomX materially breaches any of its Development or other obligations under a Research Plan or this Agreement related to such Licensed Product upon which performance of the applicable Pfizer Diligence Obligation is dependent.
Exceptions to Diligence Obligations. Notwithstanding any provision of this Agreement to the contrary, Pfizer will be relieved of all Pfizer diligence obligations to the extent that: [**]
Exceptions to Diligence Obligations. Notwithstanding any provision of this Agreement to the contrary, CytomX will be relieved from and will have no obligation to undertake any efforts with respect to any diligence obligation under Section 3.2.1 with respect to a given Licensed Product (each, a “Diligence Obligation”) in the event that ImmunoGen materially breaches any of its Development or other obligations under this Agreement related to such Licensed Product upon which performance of the applicable Diligence Obligation is dependent.
Exceptions to Diligence Obligations. Notwithstanding any provision of this Agreement to the contrary, ImmunoGen will be relieved from and will have no obligation to undertake any efforts with respect to any diligence obligation under Section 3.2.1 with respect to a given Licensed Product (each, a “Diligence Obligation”) in the event that CytomX materially breaches any of its Development or other obligations under this Agreement related to such Licensed Product upon which performance of the applicable Diligence Obligation is dependent.
Exceptions to Diligence Obligations. Notwithstanding any provision of this Agreement to the contrary, the Obligated Party will be relieved from and will have no obligation to undertake any efforts under Section 4.3.1 with respect to the Development of any Discovery Product in the event that:
(a) either Party receives or generates any safety, tolerability or other data reasonably indicating, as measured by the Obligated Party’s safety and efficacy evaluation criteria and methodology, that a Discovery Product is not reasonably suitable, for safety reasons, for initiation or continuation of Clinical Trials in humans; or
(b) the other Party materially breaches any of its Development or other obligations under the Development Plans or this Agreement and such breach impairs or limits the Obligated Party’s ability to perform its Development activities under this Agreement; provided that, in such event, the Obligated Party shall only be relieved of such obligations to the extent and for so long as the other Party’s breach so impairs or limits the Obligated Party’s ability to perform its Development activities under this Agreement.
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.
Exceptions to Diligence Obligations. Notwithstanding any provision of this Agreement to the contrary, Pfizer will be relieved from and will have no obligation to undertake any efforts with respect to any Pfizer Diligence Obligation in the event that:
(a) Pfizer or MacroGenics receives or generates any safety, tolerability or other data reasonably indicating, as measured by Pfizer’s safety and efficacy evaluation criteria and methodology, or signaling that an Agreement Product has or would have an unacceptable risk-benefit profile or is otherwise not reasonably suitable for initiation or continuation of clinical trials in humans; or
(b) Pfizer or MacroGenics receive any notice, information or correspondence from any applicable Regulatory Authority, or any applicable Regulatory Authority takes any action, that reasonably indicates that an Agreement Product is unlikely to receive Regulatory Approval.
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.
Exceptions to Diligence Obligations. Notwithstanding any provision of this Agreement to the contrary, Pfizer will be relieved of all Pfizer Diligence Obligations to the extent that Sangamo fails to fulfill its obligations under the Research Plan and such failure prevents Pfizer from fulfilling such Pfizer Diligence Obligations.
Exceptions to Diligence Obligations. Notwithstanding any provision of this Agreement to the contrary, AMAG will be relieved of all AMAG Diligence Obligations to the extent that:
(a) AMAG or Palatin receives or generates any safety, tolerability or other data indicating or signaling that a Product has or would have an unacceptable risk-benefit profile or is otherwise not suitable for initiation or continuation of Clinical Trials;
(b) AMAG or Palatin receive any notice, information or correspondence from an applicable Regulatory Authority, or an applicable Regulatory Authority takes any action, that indicates that a Product is unlikely to receive Regulatory Approval with respect to the Initial Indication; or
(c) Palatin fails to satisfactorily perform the Palatin Development Activities or other obligations under this Agreement and such failure prevents AMAG from fulfilling the AMAG Diligence Obligations.
