Phase II Development definition
Examples of Phase II Development in a sentence
The JSC shall determine the Phase II Development Timelines, the NDA Development Timelines and the Launch Development Timelines promptly upon the substantial completion of the material Development activity specified in the immediately preceding Development Timeline.
The JSC shall meet as often as agreed upon by the Parties, which shall be at least semi-annually during the conduct of the Phase II Development Plan at such places (or by teleconference or videoconference) and times agreed by the Parties; provided that the term of the JSC shall cease upon receipt by GSK of the first Approval of the Licensed Product.
If Takeda exercises the Phase II Development Option, the parties shall prepare the amendment to the Development Plan by reflecting the change of the parties’ responsibility.
The Project Team shall report to the JSC and will be primarily responsible for the day-to-day management of the conduct of the Phase II Development Plan, reviewing data resulting from such studies and trials, proposing amendments to the Phase II Development Plan to the JSC, and facilitation of the manufacturing technology transfer referred to in Section 5.2. All decisions of the Project Team on matters for which it has responsibility shall be made unanimously.
The final construction plans for the development of each submitted by the Developer for City approval shall consist of all construction documentation upon which the Developer and its contractors shall rely in building the Phase I Development and the Phase II Development.