Common use of Additional Development Proposals Clause in Contracts

Additional Development Proposals. If a Party desires to conduct a Secondary Indication Study of a Co-Co Licensed Product for the purpose of seeking Regulatory Approval to market such Co-Co Licensed Product for a Secondary Indication, such Party (the “Proposing Party”) will submit to the PJSC responsible for such Co-Co Licensed Product a proposal to add such Secondary Indication Study to the applicable Global Development Plan (an “Additional Development Proposal”). Each Additional Development Proposal will 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 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.

Additional Development Proposals. If a Party desires to conduct a Secondary Indication Study of a Co-Co Regional Licensed Product for the purpose of seeking Regulatory Approval to market such Co-Co Regional Licensed Product for a Secondary Indication, such Party (the “Proposing Party”) will submit to the PJSC responsible for such Co-Co Regional Licensed Product a proposal to add such Secondary Indication Study to the applicable Global Development Plan (an “Additional Development Proposal”). Each Additional Development Proposal will 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 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.