Pre-Clinical Development Plan means the JSC-reviewed written pre-clinical development plan for a particular Product, setting forth the pre-clinical development activities to be conducted by SERVIER or its Affiliates. Pre-Clinical Development Plans reviewed by the JSC pursuant to this Agreement shall be attached to and made a part of this Agreement and may be amended from time to time. page 8 of 67Portions of this Exhibit, indicated by the mark "[***]," were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant's application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
Examples of Pre-Clinical Development Plan in a sentence
Sanofi shall use Commercially Reasonable Efforts to complete the Pre-Clinical Development Plan during the Prior Development Phase, and Sanofi shall be responsible for all costs and expenses incurred in the performance of the Pre-Clinical Development Plan (other than unapproved budget overages incurred by Ardelyx with respect to the Assigned Activities).
The Pre-Clinical Development Plan shall include a plan for (i) [***], and (ii) [***].
The Parties shall thereafter promptly engage in discussions in good faith with the objective to agree on a final Pre-Clinical Development Plan.
Ardelyx shall promptly provide its comments on the Pre-Clinical Development Plan proposed by Sanofi.
The DAC shall serve as a joint working group for the purpose of approving the Pre-Clinical Development Plan and the Development Plan ([***] having the final decision in case of any persisting disagreement in that respect), and facilitating interactions between the Parties in relation to the performance of the Program.