Voyager Territory Development Plan. Other than Split Territory Global Development Activities, all Development activities to be undertaken with respect to each Split Territory Licensed Product by or on behalf of Voyager with respect to the Voyager Territory, including Secondary Indication Studies, shall be set forth in a written work plan and time table (each, a “Voyager Territory Development Plan”). The initial Voyager Development Plan for each Split Territory Licensed Product shall be prepared by Voyager and, following review and approval by the PSC, shall then be attached to the PSC meeting minutes and deemed to be attached hereto as Schedules 5.2.6-1, 5.2.6-2 and so forth, sequentially in order of the Option Exercise Date for the Split Territory Licensed Product that is the subject of such Voyager Territory Development Plan. Each Voyager Territory Development Plan shall set forth a rolling written work plan and time table with respect to the Development of and Secondary Indication Studies for the applicable Split Territory Licensed Product from the Option Exercise Date until the later of (a) [***] from date of such plan, and (b) receipt of Regulatory Approval for such Split Territory Licensed Product in the United States. Each Voyager Territory Development Plan shall subsequently be updated by Voyager from time-to-time at least once each Calendar Year not later than September 1 until such time as no further Development or Secondary Indication Studies are occurring or expected to occur with respect to the applicable Split Territory Licensed Product. Voyager shall present each Voyager Territory Development Plan and any proposed amendments thereto to the applicable PSC at least [***] in advance of implementation of the Voyager Territory Development Plan, and following 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. review and approval by the PSC, shall then be attached to the PSC meeting minutes and deemed to be attached hereto as the applicable Schedule. In addition, notwithstanding anything to the contrary in this Agreement, Voyager shall not conduct any Clinical Study for a Split Territory Licensed Product in a country in the Genzyme Territory without Genzyme’s prior written consent.
Appears in 4 contracts
Sources: Collaboration Agreement (Voyager Therapeutics, Inc.), Collaboration Agreement (Voyager Therapeutics, Inc.), Collaboration Agreement (Voyager Therapeutics, Inc.)