Common use of Performance Milestones Clause in Contracts

Performance Milestones. Provided that the United States Food and Drug Administration (“FDA”) does not recommend or require unanticipated studies or prerequisites, including, without limitation, pre-clinical studies or detailed characterization of control material for clinical trial use, as part of the regulatory approval process for obtaining a Licensed Product to [***], Licensee shall perform the following milestones: [***].

Performance Milestones. Provided that the United States Food and Drug Administration (“FDA”) does not recommend or require unanticipated studies or prerequisites, including, without limitation, pre-clinical studies or detailed characterization of control material for clinical trial use, as part of the regulatory approval process for obtaining a Licensed Product to [***], Licensee shall perform the following milestones. If the FDA does recommend or require such unanticipated studies or prerequisites, the parties will negotiate extensions to the milestones to reflect additional time that may be needed to achieve the following: [***].