Required Study definition
Examples of Required Study in a sentence
Notwithstanding anything in this Section 4.1 to the contrary, prior to making any decision to abandon or discontinue any of the Key Development Studies, any Replacement Study or any Replacement Indication Study (each a “Required Study”), or to change or modify any Required Study so as to effectively abandon same, Cubist shall have first provided its reasons in support of such decision to Chiron via the JCT and the JCT shall have met to discuss the merits of such decision.
At any time during the Term, if any Regulatory Authority requires additional clinical studies in connection with obtaining or maintaining Regulatory Approval for any Licensed Product in or for the Territory (each a “Required Study”), then Licensee shall notify Licensor of the need for and scope of such Required Study together with an estimated budget and timing for performing the Required Study (“Required Study Notification”).
Licensee shall pay for all Required Study Costs at the time necessary for completion of the Required Study.
Licensor shall, in a timely and responsive manner consistent with the requirements of applicable Regulatory Authorities, provide Licensee with any comments or questions concerning the Required Study.
Licensee shall have the right to proceed with the Required Study as outlined in the Required Study Notification and shall account for all internal and Third Party costs directly related to the performance of the Required Study, which costs shall be accounted for in accordance with Licensee’s accounting practices, standards and procedures (“Required Study Costs”).
Notwithstanding anything in this Section 4.1 to the contrary, prior to making any decision to abandon or discontinue any of the Key Development Studies, any Replacement Study or any Replacement Indication Study (each a "REQUIRED STUDY"), or to change or modify any Required Study so as to effectively abandon same, Cubist shall have first provided its reasons in support of such decision to Chiron via the JCT and the JCT shall have met to discuss the merits of such decision.
If AMAG does not so cure such failure, then Takeda shall have the right to conduct the Future Required Study to which the material failure pertains in accordance with the then-current Development Plan as reasonably amended by Takeda, consistent with its obligation to use Commercially Reasonable Efforts under Section 4.7, to mitigate the consequences of such failure.
The final payment shall be contingent upon the following additional conditions: • All Required Study Subject visits have been completed • Idorsia has received all Study Subject Data in a form suitable for analysis including all source documentation required for event adjudication.
The process and standards for resolving a Required Study Dispute shall be the same as those for the Launch Budget Dispute (i.e., subsection (i) shall apply mutatis mutandis), except that standards that are specific to commercialization shall not apply, and the Industry Expert shall consider and be guided in his or her decision by which Party has described the more reasonable plan and budget for the studies mandated by the FDA, EMEA or MHW.
Except with respect to any Required Study, the Global Development and Commercialization Committee (“GDCC”) shall, prior to the initiation of any OUS Study, review whether such OUS Study is also expected to generate data that will be utilized for U.S. purposes.