Indications. (a) The Parties acknowledge and agree that the initial Development Plan existing on the Execution Date covers four primary indications for Licensed Product, namely Triple-Negative Breast Cancer (“TNBC”), Non-Small-Cell Lung Cancer (“NSCLC”), Small-Cell Lung Cancer (“SCLC”), and Urothelial Cancer (“UC”) (the “First Indications”). The initial Development Plan includes the Phase I/II Study of IMMU-132 in Patients With *** (XxxxxxxxXxxxxx.xxx Identifier: NCT01631552) (the “Existing Study”).
Indications. At the time of the JSC decision regarding nomination of a potential Development Candidate targeting a given Collaboration Target, the Parties, through the JSC, shall mutually determine which potential Indication(s) to pursue for such proposed Development Candidate and the related set of Progressed Collaboration Compounds. Notwithstanding the foregoing, the Parties agree that ChemoCentryx shall have the right to pursue CCX282 and its Back-up Compounds for CCR9, in Crohn’s Disease and in the Asthma CCR9 PoC Trial as provided for in this Agreement. In the event the JSC cannot agree on such Indications, it shall proceed as provided in Section 2.3.5.
Indications. Within [***] after the Effective Date the Parties shall mutually determine the prevalence of the indications related to the Potential Targets. The designation of each Potential Target as related to a Rare Indication, a Very Rare Indication or neither a Rare Indication nor a Very Rare Indication shall be set forth on the Potential Target List and such designation shall be binding upon both Parties for all purposes hereunder. If the Parties fail to agree on such designation(s) initially, or if at a future date a Party believes that a designation should change and the other Party does not agree with such change, the Parties shall refer the matter to a mutually-agreeable technical expert to make such determination. In the event that the designation with respect to an Additional Target changes after relevant payments with respect to such Additional Target have been made, such change shall only affect payments that first become payable after the Parties first initiate discussions regarding the change in designation for such Additional Target.
Indications. Wyeth-Ayerst shall have the right to conduct Development with respect to any Licensed Compound. Wyeth-Ayerst [ * ] covenants that it shall not conduct clinical trials of any Licensed Compound for [ * ] in the USA except as provided under this Article 4.1. If Wyeth-Ayerst discovers or determines that any Licensed Compound may have efficacy in the treatment of [ * ] and if Wyeth-Ayerst desires to pursue clinical trials of such Licensed Compound for [ * ] it will promptly notify CoCensys in writing and disclose to CoCensys its rationale therefor. Wyeth-Ayerst shall have the right to pursue such clinical trials for [ * ] and market and sell such Licensed Compound as though it were a Product developed and sold for [ * ] under this Agreement, subject to the Parties negotiation of terms and conditions, including royalty rates, whether and on what terms such Licensed Compound will be Co-Promoted by the Parties, and other appropriate payment and other terms. Following such negotiation of such terms and conditions the Parties shall either enter into a separate agreement or amend this Agreement to so provide for such terms and conditions. In the event the Parties are unable to come to agreement as to the appropriate terms and conditions for the development and commercialization of such Licensed Compound for [ * ] by Wyeth-Ayerst, the matter shall be referred to the Chief Executive Officer of CoCensys and the President of Wyeth-Ayerst Laboratories, an Affiliate of Wyeth-Ayerst, for good faith resolution, for a period of [ * ]. If such matter is not resolved by the end of such [ * ] period, the Parties shall be [ * ]. Notwithstanding the
Indications. The Agent is permitted to use the Contractor as reference for all information,products or services in whichever form he deems necessary, without the Contractor having any claims to remuneration. Besides this ruling, the rights of Intellectual Property of the Austrian Jurisdiction apply.
Indications. The milestone payments for the [ * ] will be payable for any Indication, but the milestone payments for the [ * ] Indication and [ * ] Indications will only be payable if [ * ] Indication is listed in Appendix D. If a Product achieves a development milestone for multiple Indications (a) during [ * ] clinical study or (b) resulting from the filing of [ * ] Regulatory Approval application, the [ * ] Indication milestone payments will not be accumulated - only the highest milestone payment will be due. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Table 1. Early and Development Milestones Event Amount ($) Early Milestones Dosing for [ * ] testing of a compound from Renovis Technology [ * ] Issuance of a [ * ] for a Product [ * ] Development Milestones [ * ] [ * ] Commencement of Phase I Clinical Trial [ * ] [ * ] Commencement of Phase IIa Clinical Trial [ * ] [ * ] Commencement of a Phase III Clinical Trial [ * ] [ * ] Filing of NDA with FDA [ * ] [ * ] Filing of NDA equivalent with a Regulatory Authority in a member State of the EU [ * ] [ * ] Filing of NDA equivalent with the Regulatory Authority in Japan [ * ] [ * ] Regulatory Approval in U.S. [ * ] [ * ] Regulatory Approval by a Regulatory Authority in a Member State of the EU [ * ] [ * ] Regulatory Approval by the Regulatory Authority in Japan [ * ] [ * ]
Indications. Taisho will use Commercially Reasonable Efforts to obtain Governmental Approvals to Develop and Commercialize NBI-6024 in the Licensed Territory for all indications for which Neurocrine shall have obtained Governmental Approvals to Commercialize NBI-6024 in the Neurocrine Territory to the extent regulatively and practically appropriate taking into consideration the circumstances of markets in the Licensed Territory.
Indications. The MGC-SIS is indicated for improving vessel luminal diameter in the following cases: · Patients eligible for balloon angioplasty with symptomatic ischemic heart disease or a positive functional ischemia study due to discrete de novo and restenosed coronary artery lesions with a vessel reference diameter matching the final stent nominal diameter. · An elective implantation and in the treatment of acute or threatened closure associated with the coronary intervention, including saphenous vein grafts.
Indications. The initial disease indications for a Selected Collaboration Combination shall be provided in the Detailed Development Plan. Fovea shall seek the consent of the Joint Steering Committee to develop any follow-on indications not provided in the Detailed Development Plan for a Selected Collaboration Combination.