Common use of Additional Development Proposals Clause in Contracts

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.

Additional Development Proposals. If a Party If, (i) Xxxxxxx, before Geron exercises its US Opt-In Rights, or (ii) either Party, after Geron exercises its US Opt-In Rights, desires to conduct a Secondary Indication Study undertake any Proposed Trial of a Split Territory Licensed Product for the purpose of seeking Regulatory Approval to market such Split Territory Licensed Product for a Secondary IndicationProduct, then such Party (the “Proposing Party”) shall submit to the PSC responsible JDC a written proposal for the addition of such Split Territory Licensed Product a proposal to add such Secondary Indication Study trial to the applicable Split Territory Global Development Plan CDP (an “Additional Development Proposal”). Each Additional Development Proposal shall describe in reasonable detail include the Secondary Indication Study(ies) Development Proposal Criteria for the Proposed Trial and such other general content as the JSC may require; provided, however, that if 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 proposing such Proposed Trial (the “Proposing Party”) does not have all the information required to complete the Development Proposal Criteria package, it shall submit such information as it then has available in connection with the Additional Development Activities”)Proposal, as CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “and the JDC may elect to form a preclinical Working Group to evaluate the Proposed Trial of the Licensed Product for such Oncology Indication and direct such Working Group to complete the information lacking from such Development Proposal Criteria, and thereafter the completed Additional Development Proposal shall be submitted to the JDC for review. The JDC shall promptly consider the Additional Development Proposal and, no later than [**] ([*]”. 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) days of its receipt, AS AMENDED. well forward it to the JSC along with the JDC’s consensus comments, including its decision as to whether it believes that there is a proposed timeline and budget and an analysis high degree of confidence that the conduct of the business opportunity and revenue potential for Proposed Trial or its results will not adversely affect other Development or Commercialization of the Licensed Product. The JSC shall within [*] ([*]) Business Days (or such other time as may be agreed by the Parties) of its receipt of the Additional Development Activities Proposal and Secondary Indicationthe JDC’s comments, render the JSC’s decision to the Parties as to whether or not it unanimously recommends that the Parties amend the CDP (including the Development Budget) to include the Proposed Trial.