Additional Development Proposals. If a Party desires to conduct a Secondary Indication Study of a Split Territory Licensed Product for the purpose of seeking Regulatory Approval to market such Split Territory Licensed Product for a Secondary Indication, such Party (the “Proposing Party”) shall submit to the PSC responsible for such Split Territory Licensed Product a proposal to add such Secondary Indication Study to the applicable Split Territory Global Development Plan (an “Additional Development Proposal”). Each Additional Development Proposal shall describe in reasonable detail the Secondary Indication Study(ies) that the Proposing Party desires to conduct, including a synopsis of the trial, the proposed enrollment criteria, number of patients to be included, endpoints to be measured, and statistical design and powering (the “Additional Development Activities”), as 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. well as a proposed timeline and budget and an analysis of the business opportunity and revenue potential for such Additional Development Activities and Secondary Indication.
Appears in 4 contracts
Samples: Collaboration Agreement (Voyager Therapeutics, Inc.), Collaboration Agreement (Voyager Therapeutics, Inc.), Collaboration Agreement (Voyager Therapeutics, Inc.)
