Review of Lead Regulatory Party Appointments. At least six (6) months prior to the planned submission of the first Registration Filing for each Product in each Co-Commercialization Country, the Joint Steering Committee shall review the appointment of the Lead Regulatory Party for each Co-Commercialization Country. In conducting such review, the Joint Steering Committee evaluation shall be based upon the following factors: (i) the most expeditious route to Regulatory Approval with the desired labeling for the relevant Product in the relevant country; and (ii) each Party's ability to certify that it is not presently subject to, and does not reasonably anticipate becoming subject to, an FDA mandated application integrity program or other equivalent form of regulatory review that would adversely affect such Party's ability to obtain Regulatory Approval in the country in an expeditious manner. At that time, the Joint Steering Committee shall have the right to modify the Lead Regulatory Party appointment based upon such evaluation. In addition, if the Lead Regulatory Party in a Co-Commercialization Country is different from the Lead Commercialization Party in such country, then, following Regulatory Approval for the relevant Product in such country, the Joint Steering Committee may appoint a Party as both the Lead Regulatory Party and the Lead Commercialization Party so that there is one lead party for all purposes in that country; provided, however, that Idenix' right to record sales in the U.S. Territory may be abridged only if Idenix has provided its prior written consent thereto or if the Joint Steering Committee has made such a decision in which Idenix concurred.
Review of Lead Regulatory Party Appointments. Section 4.7 (g) is deleted.
