Approval for RMS Products in Major Markets Clause Samples

Approval for RMS Products in Major Markets. RMS or its Affiliates shall, at their own expense, (i) be responsible for and control the preparation and submission of any applications for Regulatory Approval, and (ii) obtain and maintain Regulatory Approvals, in each case, in the Territory for any RMS Product. For the Major Markets specified in the Project Plan and with respect to any RMS Products, RMS will be responsible for and use Commercially Reasonable Efforts to pursue: • preparing any regulatory submissions related to any RMS Product that are being developed pursuant to the Agreement; • soliciting and obtaining Epizyme’s and Eisai’s written approval of any such regulatory submission, to the extent such regulatory submission contains discussion of the Pharmaceutical Partners Product or the Clinical Patient Data; • filing any such regulatory submissions with the appropriate Regulatory Authority; • soliciting Epizyme’s and Eisai’s input for scheduled meetings with Regulatory Authorities to the extent such meetings involve discussion of the Pharmaceutical Partners Product or the Clinical Patient Data; • at Epizyme and Eisai’s request, participating in scheduled meetings of the FDA’s CBER/CDER or other Regulatory Authorities regarding development of the Pharmaceutical Partners Product for use with the RMS Product in Major Markets; • providing Epizyme and Eisai with the opportunity to participate in scheduled meetings with FDA’s CDRH or other Regulatory Authorities (at Pharmaceutical Partners’ sole expense) to the extent such meetings concern such regulatory submissions that involve discussion of the Pharmaceutical Partners Product or the Clinical Patient Data; • obtaining and maintaining any Regulatory Approvals in the Major Markets with respect to the RMS Product; and • supporting any efforts of the Pharmaceutical Partners to obtain Regulatory Approvals for the Pharmaceutical Partners Products for use with the RMS Product in the Major Markets. Excluding decisions related to regulatory submissions containing the Clinical Patient Data, all final decisions regarding content of regulatory submissions, discussions and communications with Regulatory Authorities concerning the RMS Product shall be solely with RMS; provided that, RMS shall give reasonable consideration to all input given by Pharmaceutical Partners as set forth above, including, time permitting, providing final copies of the clinical study report (CSR), labeling and the analytical sections of such regulatory submissions for Pharmaceutical Pa...