Control and Ownership of Regulatory Filings. Subject to Section 6.4, Sanofi shall have sole discretion, control and responsibility to *** (collectively, “Regulatory Filings”) in the Territory with respect to any Licensed Products in the Field; provided, that IMDZ shall be the lead party for *** as set forth in Section 6.4(d); provided, further, that Sanofi shall regularly consult with and reasonably consider comments provided by IMDZ with respect to such Regulatory Filings and, with respect to any Regulatory Filings that are reasonably likely to adversely affect an IMDZ product, shall consider IMDZ’s comments with respect thereto in good faith. All such Regulatory Filings other than *** shall be in the name of, and be owned solely by, Sanofi. In addition, Sanofi shall have sole control and responsibility in the conduct of all pricing and reimbursement approval proceedings related to the Licensed Products.
Appears in 3 contracts
Sources: License Agreement, License Agreement (Immune Design Corp.), License Agreement (Immune Design Corp.)