Lilly Responsibility and Control Clause Samples

Lilly Responsibility and Control. Subject to Section 5.5.2 and Section 5.5.3, except as provided under a Research Plan, as between the Parties, Lilly shall have sole responsibility for and control of the preparation, submission, and maintenance of all Regulatory Filings (using the IND Enabled Data Package provided by Precision) and obtaining and maintaining all Regulatory Approvals (including the preparation and submission of the IND filing and for seeking IND approval) with respect to Licensed Products, and shall have sole control over all interactions with the applicable Regulatory Authority, including all correspondence to or with the applicable Regulatory Authority. Precision shall reasonably cooperate with Lilly, at Lilly’s reasonable request and expense, with respect to any regulatory matters related to Licensed Products. Subject to Section 15.5.3, Lilly will own all right, title and interest in and to any and all Regulatory Filings and Regulatory Approvals for Licensed Products and, as between the Parties, all such Regulatory Filings and Regulatory Approvals will be held in the name of Lilly. Precision WEIL:\97737446\1\59474.0121 EXECUTION VERSION shall execute all documents and take all actions as are necessary or reasonably requested by Lilly to vest such title in Lilly. If Precision exercises its option to co-fund Clinical Development of a Licensed Product pursuant to Section 5.3, Lilly shall, upon reasonable request by Precision, provide Precision copies of Regulatory Documentation and Regulatory Filings and correspondence to or with the applicable Regulatory Authorities with respect thereto (including minutes and official contact reports relating to any communications with such Regulatory Authority) that pertain only to the Licensed Product for which Precision is co-funding Clinical Development in accordance with Section 5.3.