Technology Transfer Project Plan means a written description of the Technology Transfer, as the same may be amended from time to time by mutual written agreement of the Parties, that includes, but is not limited to, the objective, scope, approach, functional strategies, resources, roles and responsibilities, statement of work, activities, deliverables, milestones, schedule and success criteria. The Technology Transfer Project Plan will also incorporate by reference more detailed functional plans as needed (e.g., the Master Validation Plan, Comparability Plan, GMP Commissioning Plan, etc.). The Technology Transfer Project Plan is hereby incorporated into this Agreement by reference. The initial Technology Transfer Project Plan has been exchanged between the Parties as of the Effective Date and describes the understanding of the Parties (as of the Effective Date) regarding the transfer of Technology and implementation of the Manufacturing Process, test methods and testing at the Facility, and the modifications to the Facility needed to implement the Manufacturing Process at the Facility, as jointly developed by the Parties.
Examples of Technology Transfer Project Plan in a sentence
Wyeth shall use its Commercially Reasonable Efforts to complete all validation reports by sBLA Filing or earlier as defined in the Technology Transfer Project Plan and shall make all relevant validation reports applicable thereto prepared by or for Wyeth available to Genentech for review at Genentech's reasonable request.
Prior to the Sourcing Date, and subject to Section 3.1.6 hereof, the TOC shall have the authority to modify or supplement attachments and exhibits to the Technology Transfer Project Plan as necessary to ensure implementation of the Manufacturing Process in the Facility in a timely manner.
By no later than the applicable delivery deadlines set forth in the Technology Transfer Project Plan, Genentech shall deliver to Wyeth, [*] recurring shipments of (i) [*] and (ii) [*].
The Technology Transfer Project Plan includes reasonable milestones for the transfer of Technology, exchange of information, and implementation of the Technology Transfer Project, reasonable schedules for achieving such milestones, and criteria for assessing the progress and success of the project as it progresses.
Wyeth shall use its Commercially Reasonable Efforts to perform testing and evaluation of the Raw Materials as required by the applicable Raw Material Specifications or Product Specifications and cGMP, and otherwise in accordance with the Technology Transfer Project Plan, the Quality Agreement and standard operating procedures to be agreed upon in writing by the Parties.