Process Development Plan definition
Examples of Process Development Plan in a sentence
Coherus, through the JPDMC, shall develop a Process Development Plan (as well as the anticipated associated budget) for review by the JPDMC and subsequent approval by the JSC.
The Process Development Plan shall include the plan for implementing Process Developments [***] and such Process Development Plan shall include provisions for [***].
Notwithstanding the foregoing, if a Regulatory Authority or Applicable Laws requires a change to a Process Development Plan, the JPDMC shall revise the Process Development Plan to the extent necessary to comply with such requirement and shall promptly submit the revised Process Development Plan to the JSC for approval.
Coherus shall use Commercially Reasonable Efforts to conduct all Development and Process Development activities in accordance with the Development Plan or the Process Development Plan (as applicable) and the terms of this Agreement.
Coherus shall retain sole responsibility for performing any activities under an approved Process Development Plan[***].
Subject to the oversight of the JDC, the JPDMC and the JSC ([***]), Coherus shall be solely responsible for carrying out all activities set forth in the Development Plan and the Process Development Plan.
Any amendment or update to an approved Process Development Plan is subject to review by the JPDMC and approval by the JSC.
The Process Development Plan shall be consistent with and shall not contradict the terms of this Agreement without the written consent of the Parties, and in the event of any inconsistency between the Process Development Plan and this Agreement, the terms of this Agreement shall prevail.
The JPDMC will be responsible for reviewing Process Development, progress and development of analytical methods and analysis, Product formulations, coordination of Process Development and Manufacturing related activities and the review, modification as necessary and recommendation for approval to the JSC of a Process Development Plan.
Licensee shall bear all costs and expenses for the activities contemplated in the Process Development Plan pursuant to Section 4.1(d)(iii)(1).