Right of Reference to Regulatory Materials. Each Party hereby grants to the other Party the right of reference to all Regulatory Materials pertaining to the Licensed Product in the Field submitted by or on behalf of such Party. Servier may use such right of reference to [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Miragen’s Regulatory Material in the Field solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of the Licensed Products in Field in the Territory. Miragen may use the right of reference to Servier’s Regulatory Material in the Field solely for the purpose of seeking, obtaining and maintaining regulatory approval of the Licensed Products outside the Territory. Notwithstanding the foregoing, each Party may use the right of reference to any Regulatory Materials based on data resulting from the Unsponsored Work conducted by the other Party only to comply with the regulatory requirements (in particular with respect to safety reporting) in such Party’s territory, unless such Party reimburse the other Party a portion of the Unsponsored Work Development Costs as set forth in Section 5.4(c).
Appears in 2 contracts
Sources: License and Collaboration Agreement (Signal Genetics, Inc.), License and Collaboration Agreement (Signal Genetics, Inc.)