Additional Development Proposals. If a Party desires to conduct (i) a Supplemental Study of a Regional Licensed Product for a Regional Target for the purpose of seeking Regulatory Approval to market such Regional Licensed Product, or (ii) Regional [***] Activities, such Party (the “Proposing Party,” and such other Party, the “Non-Proposing Party”) will submit to the JDC a proposal to add such Supplemental Study or Regional [***] Activities, as applicable, to the applicable RLP Development Plan (an “Additional Development Proposal”). Each Additional Development Proposal will describe in reasonable detail the applicable Regional Target or Regional [***] Candidate, the Supplemental Study(ies) or Regional [***] Activities that the Proposing Party desires to conduct, including a synopsis of the trial or activities, 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.
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. Either party may at any time make proposals for additional development and commercialization opportunities outside of the process described in this Section 18, but if the parties do not agree, then no default licenses will be granted and no default revenue sharing or royalty terms will apply.
Additional Development Proposals. If a Party (such Party, the “Proposing Party”) desires to undertake Additional Development Activities, such Party shall submit to the JPT a proposal for the addition of such Additional Development Activities to the Development Plan that includes a proposed work plan, timeline and budget for such Additional Development Activities (an “Additional Development Proposal”). The Additional Development Proposal shall be prepared in a similar scope and format of a Development Plan. The Proposing Party shall provide the JPT with any additional Information related to the Additional Development Proposal reasonably requested by the JPT. Confidential 42 *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
Additional Development Proposals. If a Party desires to undertake Additional Development Activities, such Party shall submit to the JDC a proposal for the addition of such Additional Development Activities to the Development Plan (an “Additional Development Proposal”). Each Additional Development Proposal for Additional Development Activities shall include a general description of the Development activities including, as applicable, study design, clinical study endpoints, clinical methodology and monitoring requirements, and the funding budget. If the JDC approves an Additional Development Proposal, such Additional Development Proposal shall, within [**] days, be submitted to the JSC for review and approval.
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. Subject to Section 3.5 (Limits on Development; No Other Development), if either Party proposes to Develop a Licensed Product that the Parties previously agreed to Develop under the Global Development Plan (including a Co-Formulated Product), either as (i) a Licensed Product for a new Indication, or (ii) a Licensed Product as part of a Co-Administration Study (i.e., an existing Co-Administration Therapy in a new Indication or a new Co-Administration Therapy in a new or existing Indication), in each case of (i) or (ii), other than in Indications or in Co-Administration Studies set forth in the then-current Global Development Plan (each, “Proposed Additional Development”), then the proposing Party will present to the JDC to review and discuss, and submit, within [***], to the JSC to review, discuss and determine whether to approve a proposal to add such Proposed Additional Development to the Global Development Plan, including the countries in which such activities would be conducted (which will include at least the U.S. or the European Union) and the allocation of performance of such activities between the Parties (an “Additional Development Proposal”). Each Additional Development Proposal will describe in reasonable detail the applicable non-clinical studies, pre-clinical studies and Clinical Trials, in each case, that the proposing Party desires to conduct as part of such Proposed Additional Development, including a synopsis of the Clinical Trial or other activities, the proposed enrollment criteria, the number of patients to be included, the endpoints to be measured, and the statistical design and powering (the “Additional Development Activities”), as well as a proposed timeline and budget (which budget will include the expected Development FTE Costs, Out-Of-Pocket Costs and Manufacturing Costs to be incurred in the conduct of such Additional Development Activities) and an analysis of the business opportunity and revenue potential for such Additional Development Activities.
Additional Development Proposals. If a Party desires to conduct a Supplemental Study of a Regional Licensed Product for a Regional Target Pair such Party (the “Proposing Party” and such other Party, the “Non-Proposing Party”) will submit to the JDC a proposal to add such Supplemental Study to the applicable RLP Development Plan (an “Additional Development Proposal”). Each Additional Development Proposal will describe in reasonable detail the applicable Regional Target Pair and the Supplemental Study(ies) that the Proposing Party desires to conduct, including a synopsis of the trial or activities, the proposed enrollment criteria, number of patients to be included, endpoints to be measured, estimated drug supply requirements 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.
Additional Development Proposals. 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 undertake any Proposed Trial of Licensed Product, then such Party shall submit to the JDC a written proposal for the addition of such trial to the CDP (an “Additional Development Proposal”). Each Additional Development Proposal shall include the Development Proposal Criteria for the Proposed Trial and such other general content as the JSC may require; provided, however, that if the Party 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 Proposal, 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 [*] ([*]) days of its receipt, forward it to the JSC along with the JDC’s consensus comments, including its decision as to whether it believes that there is a high degree of confidence that the conduct of the 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 Proposal and the 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.
Additional Development Proposals. If a Party desires to undertake Additional Development Activities, such Party shall submit to the JDC a proposal for the addition of such Additional Development Activities to the GDP (an “Additional Development Proposal”). Each Additional Development Proposal for Additional Development Activities shall include Development Proposal Criteria; provided, however, that if an Additional Development Proposal is for Development of a Product for a Tumor Type or Indication not contemplated by the then-current GDP and the Party proposing such Additional Development Activities does not have all the information necessary to include full Development Proposal Criteria in the Additional Development Proposal, it shall submit such information as it has available in connection with the Additional Development Proposal, and the JDC may elect to form a preclinical Working Group to investigate the Development of the Product for such Tumor Type or Indication and direct such Working Group to develop and propose applicable Development Proposal Criteria, which Development Proposal Criteria shall be submitted to the JSC for review and approval no later than 45 days after the JDC’s approval of the Additional Development Proposal. If the JDC approves an Additional Development Proposal, such Additional Development Proposal shall, within 10 days, be submitted to the JSC for review and approval.
