Split Territory Licensed Products. Subject to Section 6.2.7.2 (Existing PD IND), each Party hereby grants to the other Party, and at the request of the other Party will grant to the other Party’s Related Parties, the right to rely upon and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Studies or Secondary Indication Studies (to the extent provided in Section 5.2.5 (Secondary Indications)) or early access/named patient programs for the Split Territory Licensed Products) included in or used in support of any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) owned or controlled by such Party or its Related Parties that relates to any Split Territory Licensed Product to the extent necessary or useful to obtain Regulatory Approval of a Split Territory Licensed Product in the Genzyme Territory or the Voyager Territory, and such Party shall, if requested by the other Party, provide a signed statement that the other Party may rely on, and the Regulatory Authority may access, in support of the other Party’s application for such Regulatory Approval in its Territory, any underlying raw data or information submitted by such Party to the Regulatory Authority with respect to any regulatory filing, Regulatory Approval, drug master file or other regulatory documentation (including orphan drug applications and designations) owned or controlled by such Party or its Related Parties that relates to any Split Territory Licensed Product. In addition, upon request of either Party (on behalf of itself or a Sublicensee), the other Party shall obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Split Territory Licensed Products in the Genzyme Territory or the Voyager Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments). Notwithstanding anything to the contrary in this Agreement, neither Party shall withdraw or inactivate any regulatory filing that the other Party references or otherwise uses pursuant to this Section 6.2.7.1. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
Appears in 4 contracts
Samples: Collaboration Agreement (Voyager Therapeutics, Inc.), Collaboration Agreement (Voyager Therapeutics, Inc.), Collaboration Agreement (Voyager Therapeutics, Inc.)
