Significant Development Event means any of the following material Development events, a summary of which shall be included in any Development Report: (a) any material interaction and/or written correspondence between TGTX or its Sublicensees and any Regulatory Authority with respect to a Compound or a Licensed Product; (b) any material event with respect to any Clinical Trial involving the Compound and/or a Licensed Product, including any such event that is ongoing as of the date of the applicable Development Report, or is reasonably expected to occur or be initiated within twelve (12) months of the date of the applicable Development Report; and (c) any material result obtained in the conduct of any Clinical Trial involving a Compound and/or a Licensed Product during the period covered by the Development Report. For purposes of this definition, “material” shall be defined as any event and/or result which have had or may have a significant impact on the activities and timelines defined in the Development Plan of a Licensed Product.
Significant Development Event means any of the following material Development events: (a) any material interaction and/or written correspondence between a Party or any of its Affiliates and any Regulatory Authority with respect to the Product; or (b) any material event or result with respect to any Clinical Trial involving the Product.
Significant Development Event means any of the following material Development events, a summary of which shall be included in any Development Report: (a) any material interaction and/or written correspondence between ILDONG and any Regulatory Authority with respect to the Compound or a Product; (b) any material event with respect to any Clinical Trial involving the Compound and/or a Product, including any such event that is ongoing as of the date of the applicable Development Report, or is reasonably expected to occur or be initiated within twelve (12) months of the date of the applicable Development Report; and (c) any material result obtained in the conduct of any Clinical Trial involving the Compound and/or a Product during the period covered by the Development Report. For purposes of clarity, all information provided to SUBLICENSOR with respect to Significant Development Events, shall be deemed to be Confidential Information of ILDONG. For purposes of this definition, “material” shall be defined as any event and/or result which have had or may have a significant impact on the activities and timelines defined in the Development plan of each Product.
More Definitions of Significant Development Event
Significant Development Event means any of the following material Development events, a summary of which shall be included in any Development Report: (a) any material interaction and/or written correspondence between Company and any Regulatory Authority with respect to the Product; (b) any material event with respect to any Clinical Trial involving the Product conducted by or on behalf of Company, including any such event that is ongoing as of the date of the applicable Development Report, or is reasonably expected to occur or be initiated within [***] ([***]) [***] of the date of the applicable Development Report; and (c) any material result obtained in the conduct of any Clinical Trial involving the Product conducted by or on behalf of Company during the period covered by the Development Report. For purposes of clarity, all information provided to TG with respect to Significant Development Events, shall be deemed to be Confidential Information of Company. For purposes of this definition, “material” shall be defined as any event and/or result which have had or may have a significant impact on the activities and timelines defined in the Development Plan of the Product.
Significant Development Event means any of the following material Development events, a summary of which shall be included in any summary report: (a) any material interaction and/or written correspondence between Cara and any Regulatory Authority with respect to the Manufacture of a Product; (b) any material event with respect to any clinical trial involving the Manufacture of a Product; and (c) any material result obtained in the conduct of any clinical trial involving the Manufacture of a Product during the period covered by the Development report. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE SWK HOLDINGS CORPORATION HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CARA THERAPEUTICS, INC. IF PUBLICLY DISCLOSED. - 12 -
Significant Development Event means any of the following material Development events, a summary of which shall be included in any Development Report: (a) any material interaction and/or written correspondence between ArQule and any Regulatory Authority with respect to any Collaboration Compound or Product during the period covered by the Development Report; (b) any material event or result with respect to any GLP Toxicity Study and/or Clinical Trial involving any Collaboration Compound or Product during the period covered by the Development Report; and (c) any material event that occurs under a license agreement that is executed by ArQule in connection with an Out-Licensing Transaction.
Significant Development Event means any of the following material Development events, a summary of which shall be included in any summary report: (a) any material interaction and/or written correspondence between Cara and any Regulatory Authority with respect to the Manufacture of a Product; (b) any material event with respect to any clinical trial involving the Manufacture of a Product; and (c) any material result obtained in the conduct of any clinical trial involving the Manufacture of a Product during the period covered by the Development report.