The JCC shall approve the first Commercialization Plan for each Licensed Product in each of the US Territory and the ROW Territory no later than [**] prior to the anticipated First Commercial Sale of the first such Licensed Product in the US Territory and the ROW Territory, respectively. Thereafter, the JCC shall review and approve the Commercialization Plan(s) (for the current Calendar Year and the next succeeding Calendar Year) each Calendar Year (provided that, in the event the JCC is unable to agree on such proposed plan, the Lead Party in the applicable Territory shall have the final say for its portion of the proposed Commercialization Plan). Either Party may also develop and submit to the JCC for review from time to time other proposed amendments to the applicable Commercialization Plan(s). The initial Commercialization Plan(s), and any amendments and updates to the Commercialization Plan(s), shall be effective upon the approval of the JCC.