Examples of ROW Development in a sentence
Promptly after the CCPS Agreement Effective Date, Celgene will prepare an initial ROW Development Plan and will provide it to the JGC for purposes of discussion and the goal of coordinating and harmonizing the U.S. Development Plan and the ROW Development Plan.
As of and after the CCPS Agreement Effective Date, subject to the terms and conditions of this CCPS Agreement, the Parties will assume through the JGC joint responsibility for Development of Elected Candidate and Licensed Product for U.S. Administration, under the U.S. Development & Commercialization Program, and Celgene will assume responsibility for Development of Elected Candidate and Licensed Product for ROW Administration, under the ROW Development & Commercialization Program.
Such reports shall set forth in summary form the results of GSK's Development activities with respect to Collaboration Products for Commercialization in the ROW performed during such semi-annual period and any updates to such ROW Development Plan.
API Compound requirements for Development activities shall be set forth in the relevant U.S. Development Plans and ROW Development Plans and shall be periodically updated by the Joint Supply Committee in coordination with the Joint Development Committee and the Joint Steering Committee.
For avoidance of doubt, the JGC will have no right to supervise or direct the Development and Commercialization of Elected Candidate or Licensed Product for ROW Administration, and Celgene will have sole decision making authority with respect to such Development and Commercialization, including with respect to the ROW Development & Commercialization Program.
In the event that GSK fails -------------------------------- to achieve any of the timeline events set forth in this Section 16.8 or in the U.S. Development Plan or ROW Development Plan, as applicable, due to a delay by Adolor to supply API Compound necessary to achieve such timeline events, then the timeline shall be extended by a period of time equal to the length of such delay.
Promptly after the CCPS Agreement Effective Date, Celgene will prepare an initial U.S. Development Plan, and the JGC will review and approve such initial U.S. Development Plan, with the goal of coordinating and harmonizing the U.S. Development Plan with the ROW Development Plan.
As early as necessary in each year beginning with the first full ------- Calendar Year after the Effective Date, GSK shall prepare a Development plan for each Collaboration Product in the ROW (each, a "ROW Development Plan") so that -------------------- it can submit such ROW Development Plans to the Joint Steering Committee no later than September 30 of such year for review.
Formulated Collaboration Product requirements for Development activities shall be set forth in the relevant U.S. Development Plans and ROW Development Plans and shall be periodically updated by the Joint Supply Committee in coordination with the Joint Development Committee and the Joint Steering Committee.
Thereafter, Celgene will update the ROW Development Plan each year and submit it to the JGC for purposes of discussion and the goal of coordinating and harmonizing the U.S. Development Plan and ROW Development Plan.