Communication with PMDA Clause Samples

Communication with PMDA. Maruho shall have the sole responsibility in close consultation with Upstream and consistent with Upstream’s global development strategy, to communicate with the PMDA regarding the Product in Japan. With respect to any filing, material communication or other submission with the PMDA regarding the Product in Japan, (a) Maruho shall provide Upstream with an advance copy of the reasonably complete draft thereof; (b) Upstream shall have a reasonable opportunity to review, comment and consult on each such draft, taking into consideration any PMDA response deadline; and (c) Maruho shall consider the reasonable comments of Upstream in good faith. Maruho shall provide Upstream with the final form of each such written communication within [***] after submission to the PMDA. With respect to any meetings, telephone conferences, video conferences or other non-written communication with the PMDA regarding the Product in Japan, Maruho shall provide Upstream with reasonable advance written notice thereof and use commercially reasonable efforts to allow Upstream the opportunity to have representatives actively participate therein.