Study Conditions Clause Samples

Study Conditions. (a) Prior to initiating any INCY Pipeline Combination Study in the Field in the Zai Lab Territory, INCY will provide to the JDC a study schematic for the INCY Pipeline Combination Study. INCY will not initiate the INCY Pipeline Combination Study if Zai Lab reasonably believes that such study would have a material adverse impact on the safety profile of a corresponding Licensed Product(s) in the Field in the Zai Lab Territory and Zai Lab provides its rationale for such belief. (b) After initiating any INCY Pipeline Combination Study in the Zai Lab Territory, INCY will permit Zai Lab to review and comment on, and allow Zai Lab to participate in, any material interactions with Regulatory Authorities in the Zai Lab Territory that relate solely to the Licensed Product(s) being evaluated in the INCY Pipeline Combination Study (excluding interactions with Regulatory Authorities in the Zai Lab Territory that relate to an INCY Pipeline Assets) and will consider in good faith any Zai Lab comments relating to such regulatory interactions until such time as the associated Licensed Product(s) is the subject of a Regulatory Approval in the Zai Lab Territory. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED WITH [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.