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”).
(b) On an ongoing basis during the term of the Agreement, while the JSC continues, the Parties shall, via the JSC or the JDC, further review and ***, including both other types of *** approved (for example, ***, etc.) and (ii) ***.
(c) may, from time to time, propose additional potential indications and/or potential combination therapies to the JSC, which proposal shall include a reasonably detailed description of (i) the rationale for pursuing such indication or combination therapy and (ii) the clinical trial(s) that *** would recommend undertaking in order to pursue such indication or combination therapy. The JSC shall consider these proposals in good faith and in a timely manner, ***. The JSC may, in its sole discretion, ***. Notwithstanding the foregoing, the JSC shall not be required to consider, and may in its sole decision decline, any proposal relating to a Terminated Indication.
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. This is a general description of the disease or condition that the device will diagnose, treat, prevent, cure or mitigate and includes a description of the target patient population for which the device is intended.
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. 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 CCX282 Back-up Compounds for CCR9, in Crohn’s Disease, in asthma as reflected in the Asthma CCR9 PoC Trial and in the Celiac Indication as reflected in a Celiac 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.
5. Section 3.7.2 is hereby amended by adding the following new paragraph (e):
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 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.
Indications. The Principal shall upon receiving notice of suspension or withdrawal of its management system certification, discontinue all use of all advertising matter/declarations that contains a reference to verification/validation, as instructed by the Company, and revise all advertising matter accordingly when the scope of certification has been reduced. The right to use the Company indication is granted to the Principal on a non-exclusive basis. The Principal is allowed to use the Company indication on certified products for which a product scope certificate has been issued by the Company. When making reference to the validation/verification statement granted by the Company in media such as documents, brochures or advertising, the Principal shall at all times comply with the requirements imposed by the validation/verification body or as specified in the validation/verification scheme. The Principal shall comply with any requirements that may be prescribed in the validation/verification program relating to the use of marks of conformity, and on information related to the product. The Company is entitled to unilaterally amend (the terms of) the Documents. The Company shall inform duly the Principal in writing about any amendment of the Documents which are relevant to the Agreement and it shall notify the Principal of the day these amendments to the Documents come into effect. In case of an amendment to the terms of the Documents as contemplated by Article 8.1 hereof, the Principal agrees to be unconditionally bound to the terms of these new documents. The Company and the Principal acknowledge and agree that any such revised terms shall replace the relevant terms of the former Documents as of the day the amendments come into effect. The PCC Common Agreement Procedures may be developed or modified during the engagement if the intended users take responsibility for the adequacy of these procedures for their purposes. If circumstances prevent the verifier from implementing the procedures, the verifier should attempt to obtain the agreement of the intended users to modify the procedures. If agreement cannot be reached, the verifier should describe the limitation in the report or withdraw from the engagement.
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. 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. Dosing for [ * ] testing of a compound from Renovis Technology [ * ] Issuance of a [ * ] for a Product [ * ] 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 [ * ] [ * ]
