FCDI Regulatory Responsibilities Clause Samples

FCDI Regulatory Responsibilities. FCDI shall file, establish, and maintain in its own name all applicable Cell Line Regulatory Submissions with respect to the Approved iPSC Lines (that are cGMP-grade iPSC Lines) that are necessary for obtaining any Regulatory Approval for any Specified Product. Subject to the rights granted to Licensee under this Article 6 (Regulatory Matters), FCDI shall own all rights, title, and interests in and to all such Cell Line Regulatory Submissions.