Product Labeling in the Territory Sample Clauses

Product Labeling in the Territory. The core safety information for the Product will be prepared and maintained by CVT including as provided in the Safety Agreement. To the extent permitted by applicable Laws, MIOL shall use CVT’s core safety information as a guide when developing local labeling for the Product. CVT and MIOL shall use good faith efforts to achieve consensus on matters related to Product labeling, including all material safety issues and all labeling objections. During the Term, CVT shall have the right to object to any proposed labeling that MIOL proposes to submit for the Product in the Territory on the grounds that (i) such labeling will have a material adverse effect on the Commercialization of the Product for such indication in the Territory or in the United States or elsewhere outside the Territory or (ii) such labeling is not consistent with the core safety information for the Product maintained by CVT; and MIOL shall also have such rights with respect to the labeling in the EU prior to the transfer of the MAA to MIOL. In the event either Party exercises its right to object hereunder, the Parties shall use good faith efforts to resolve such objection by mutual agreement.