Existing Trials. The Parties acknowledge and agree on the importance of conducting the Existing Trials in accordance with the Transition Plan and Trial Completion Plan. Notwithstanding any other provision of this Agreement, no Existing Advanced Trial will be terminated or wound down (other than as set forth in the relevant Trial Completion Plan) other than in the following circumstances: (a) if at any time LICENSEE becomes aware of safety concerns with respect to the relevant Product in a given indication, LICENSEE may terminate or wind down the Existing Advanced Trial in the same indication (or if in the reasonable judgment of LICENSEE, such safety concerns affect the Product regardless of indication, both Existing Advanced Trials) without any need for PFIZER’s consent thereto, provided that LICENSEE shall discuss such concerns with PFIZER; (b) if, on a trial-by-trial basis, after the date which is [***], any of the following events occurs, LICENSEE may terminate or wind down such Existing Advanced Trial without any need for PFIZER’s consent thereto, provided that LICENSEE shall discuss such events with PFIZER: (i) the occurrence of material changes in the market for, or the commercial potential of, the relevant Product, (ii) material adverse changes in the intellectual property protection available for the relevant Product (other than by reason of any actions taken by LICENSEE), or (iii) LICENSEE becomes aware of any material change in data that indicates that the relevant Product will not be efficacious for the indication being studied in such Existing Advanced Trial; or (c) except as set forth in clause (a) or (b) above, only with PFIZER’s prior written consent (not to be unreasonably withheld).
Appears in 2 contracts
Sources: License Agreement (Puma Biotechnology, Inc.), License Agreement (Puma Biotechnology, Inc.)