Core Indication definition
Examples of Core Indication in a sentence
In addition to the milestone payments specified above upon achievement of the milestone for the first Core Indication for each Product, BI shall pay milestone payments equal to fifty (50%) of the regulatory milestone payments set forth in Section 9.3.2 for the second separate Core Indication (e.g., hypertension) for each Product, but not for label extensions to a primary diabetes indication.
BI and Vitae have agreed to expand the definition of the Core Indication.
Astellas shall pay FibroGen $[ * ] US dollars upon the first Marketing Approvals in a Core Indication (except for [ * ]) in [ * ].
In addition, Schering shall provide to Novacea monthly updates of patient enrollment information for any Phase III Studies in a Core Indication or for pancreatic cancer (“Monthly Update Report”), provided, however, (i) it is understood that such information will be based solely on the information Schering receives as reported from clinical trial sites and (ii) to the extent Novacea is responsible for such a study, Novacea shall provide a Monthly Update Report to Schering.
Without limiting the foregoing, BI shall use Diligent Efforts to (i) advance at least ****for type 2 diabetes or another Core Indication ready for Phase I Studies; (ii) advance ****through Development in accordance with the stage gates identified in the then current Development Plan for such Product; (iii) efficiently Develop the Products; and (iv) obtain Marketing Authorization Approvals to market the Products in Major Markets (as contemplated in Section 8.2).
Indication due to Technical Failure and promptly commences advancement of a back-up Product for the same Core Indication, then the relevant Milestone Timing set forth in Section 5.2.1 shall be extended by a reasonable period of time necessary to perform or re-perform the Development with such Product or back-up Product.
Sanofi, itself or through its Affiliates or sublicensees, shall use Commercially Reasonable Efforts to seek Regulatory Approval for and Commercialize the Product in the Core Indication in the Sanofi Territory and to launch the Product in each of the Major Market Countries within a period of six (6) months following Regulatory Approval in such country.
Upon Vivus’ request in writing, Sanofi may consider the grant to Vivus of a royalty bearing license under the Sanofi Technology to Develop and Commercialize in the Vivus Territory: (i) any Product Developed by Sanofi containing a Compound in combination or association with one or more active ingredients and/or (ii) the Product in any indication other than the Core Indication, subject to the good-faith negotiations between the Parties of the terms and conditions applying to such license.