Incremental Studies Sample Clauses
Incremental Studies. (i) If all information reasonably requested by the non-proposing Party has been provided by the proposing Party and (A) by the [*] after the JDC meeting at which a particular Proposed Study in an Oncology Indication (including a Proposed Study for a New Form that is intended for use in an Oncology Indication) is discussed (or such longer period of time as agreed upon in writing by the Parties) under Section 4.4(a): (x)
(1) the other Party has not notified the proposing Party in writing that the other Party wishes to cooperate in such Proposed Study on the terms (including design, budget and timeline) proposed by the proposing Party, or (2) the Parties have not agreed in writing upon the terms (including design, budget and timeline) under which they will cooperate in such Proposed Study, and (y) the other Party has not notified the proposing Party that it believes that such Proposed Study is substantially likely to create a Material Impact; or (B) by the [*] after the JSC meeting at which a particular Proposed Study in a Non-Oncology Indication (including a Proposed Study for a New Form that is intended for use in a Non-Oncology Indication) is discussed (or such longer period of time as agreed upon in writing by the Parties) the JSC does not decide to approve a Proposed Study under Section 4.4(b), then in either case ((A) or (B)), such Proposed Study will be deemed an "Incremental Study", the proposing Party shall be deemed the "Conducting Party" with respect to such Incremental Study, the other Party shall be deemed the "Non-Conducting Party" with respect to such Incremental Study and, unless the Conducting Party notifies the JDC that it does not wish to proceed with such Incremental Study, the Development Plan shall be amended pursuant to Section 4.2(c) to include such Incremental Study and to specify the Conducting Party as solely responsible for the conduct and costs of such Incremental Study and the Non-Conducting Party shall not be responsible for any costs, including milestones, unless such Non-Conducting Party opts-in to such Incremental Study pursuant to Section 4.4(c)(v). The Conducting Party may proceed with such Incremental Study after such amendment of the Development Plan. If the non-proposing Party believes that such Proposed Study is substantially likely to create a Material Impact and the proposing Party disputes whether such belief is reasonable, the JSC shall discuss and decide whether such belief is reasonable. The Proposed Study shall b...
