DAC Development Responsibilities. The DAC shall have the following responsibilities with respect to the Development of Voyager CNS Orphan Disease Programs, Collaboration Programs and Collaboration Products: (a) reviewing and discussing Voyager’s determinations as to whether to pursue a potential product development program as a Voyager CNS Orphan Disease Program in accordance with Section 2.2.1 (Voyager CNS Orphan Disease Programs); (b) reviewing and discussing periodic updates regarding the development of Voyager CNS Orphan Disease Programs provided by Voyager in accordance with Section 2.2.3 (Information Sharing for Voyager CNS Orphan Disease Programs); (c) approving the discontinuation of the FA Collaboration Program, HD Collaboration Program or PD Collaboration Program prior to Human POP Study Completion in accordance with Section 2.2.4 (Designation of Future Collaboration Program); (d) making [***] Process Elections pursuant to Section 4.7.1 ([***] Process Election for Split Territory Agreement Products); (e) reviewing and discussing periodic updates regarding the Development of Collaboration Programs and Collaboration Products provided by Voyager in accordance with Section 4.11.1 (Development Activities Reports); (f) reviewing, commenting on and approving updates and amendments to the Collaboration R&D Plans for Collaboration Programs in accordance with Section 4.3.4 (Updates and Amendments to Collaboration R&D Plans); (g) reviewing and approving the use of Genzyme PD Technology in PD Agreement Products in accordance with Section 4.5 (Use of Genzyme PD Technology); (h) reviewing and approving the use of Genzyme HD Sequences as the transgene in HD Agreement Products in accordance with Section 4.6 (Use of Genzyme HD Sequence); (i) reviewing, commenting on and approving the protocol for each Human POP Study in accordance with Section 4.9 (Human POP Studies); (j) reviewing, commenting on and approving the initial Split Territory Global Development Plans for Split Territory Licensed Products in accordance with Section 4.12 (Initial Split Territory Global Development Plan for Split Territory Licensed Products); 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. (k) approving the use of any Third Party to perform Development or Manufacturing activities on Voyager’s behalf in accordance with Section 4.13 (Third Parties); and (l) performing such other activities as the Parties agree in writing shall be the responsibility of the DAC or that are otherwise assigned to the DAC under this Agreement.
Appears in 4 contracts
Samples: Collaboration Agreement (Voyager Therapeutics, Inc.), Collaboration Agreement (Voyager Therapeutics, Inc.), Collaboration Agreement (Voyager Therapeutics, Inc.)