Back-Up Compounds. (a) Selection of Back-up Compounds.
(i) As required pursuant to Section 2.7, DTI will provide to Fujisawa on the Effective Date all of its data and DTI Know-How regarding its A1 Agonist Library. During the sixty (60) day period following the Effective Date (the "Back-up Compound Notice Period"), DTI covenants that it will not license (in whole or in part), conduct, fund, develop or participate directly or indirectly through, one or more Third Parties the research, development, distribution or commercialization in the Territory of any compound in the A1 Agonist Library for use as an Injectable Product for any indication in the Field (including without limitation PSVT and/or AFIB/F). During such Back-up Compound Notice Period, Fujisawa may, at its option, provide written notice to DTI designating up to three (3) compounds from the A1 Agonist Library as Back-up Compounds. If Fujisawa so designates any Back-up Compound(s) during the Back-up Compound Notice Period, DTI covenants that it will not license (in whole or in part), conduct, fund, develop or participate in directly or indirectly through, one or more Third Parties the research, development, distribution or commercialization in the Territory of such Back-up Compound(s) for use as an Injectable Product for any indication in the Field (including without limitation PSVT and/or AFIB/F).
(ii) If, after the expiration of the Back-up Compound Notice Period, Fujisawa does not make any such designation of Back-up Compounds, or designates less than three (3) Back-up Compounds, DTI may, subject to the restrictions in Section 2.5, license, conduct, fund, develop or participate in directly or indirectly through one or more Third Parties, the research, development, distribution or commercialization of any of the remaining compounds in the A1 Agonist Library (hereafter the "Remaining Compound(s)") for any indications other than the Primary Indications and in any formulation other than Injectable Products.
(iii) At any time after the expiration of the Back-up Compound Notice Period, and in the event Fujisawa has designated less than three (3) Back-up Compounds during the Back-up Compound Notice Period, Fujisawa may request in writing to designate any Remaining Compounds as Back-up Compounds; provided, that the total number of Back-up Compounds under this Agreement shall not exceed three (3). If Fujisawa makes such Back-up Compound designation with respect to a Remaining Compound for which DTI (or its sublicensee or con...
Back-Up Compounds. Biogen Idec may, in its discretion, at any time during the Research Term, designate (i) any number of Development Compounds, (ii) any number of Lead Compounds that are Biogen Idec Proprietary Compounds and (iii) up to [***] Lead Compounds that are not Biogen Idec Proprietary Compounds as “Back-Up Compounds” with respect to any one Development Compound (such Development Compound, a “Primary Development Compound”). If Biogen Idec determines, in its sole discretion based on criteria similar to how Biogen Idec makes determinations with respect to its own therapeutic programs, taking into account such factors as development feasibility, commercial viability, and intellectual property protection, that the Development of a Primary Development Compound has not yielded sufficient progress and that Development activities with respect to such Primary Development Compound should be discontinued, then Biogen Idec may designate one of the Back-Up Compounds for such Primary Development Compound as a substitute for such Primary Development Compound, and such Back-Up Compound will then be considered the Primary Development Compound. In such case, the discontinued Primary Development Compound will be deemed to be a Back-Up Compound for such new Primary Development Compound. In order to maintain a Lead Compound as a Back-Up Compound, Biogen Idec will be required to establish that it is using Commercially Reasonable Efforts applicable to Back-Up Compounds in connection with the Development of such Back-Up Compound.
Back-Up Compounds. (i) It is understood that the JRC (or the JDC, as applicable) will identify Back-Up Compounds as contemplated by Sections 1.7, 1.14, 1.23, 1.47, and 1.98 and the compounds that contain the Pharmacophore or any series of compounds demonstrating activity against a Target as contemplated by Sections 1.14(a)(iv), 1.23(d), 1.47(d), and 1.98(a)(iv). When the JRC (or the JDC, as applicable) identifies a Collaboration Compound to be designated as a Back-Up Compound in a Program, such Collaboration Compound can only be so designated if it has not previously been allocated to another Program or if the Committee by Mutual Consent (after disclosure of the previous allocation of such Collaboration Compound to another Program) determines to designate such Collaboration Compound as a Back-Up Compound to such second Program.
(ii) As part of Agios’ Development responsibilities, upon Celgene’s written request at any time following IND Acceptance for a Development Candidate under a Licensed Program, Agios will advance the Development of [**] related to such Development Candidate through IND-Enabling Studies; provided that, regardless of the results of the IND-Enabling Studies, Agios shall not be required to pursue additional IND-Enabling Studies for such [**] under such Licensed Compound. All costs associated with Development of such [**] through such IND-Enabling Studies shall be at Agios’ sole cost and shall not be Development Costs to be reimbursed by Celgene hereunder; and Agios shall not be entitled to an IND Amount with respect to any Back-Up Compounds. Subject to the foregoing, if none of the [**] Developed by Agios and included within a Licensed Program meet the Clinical Candidate Guidelines, upon Celgene’s written request, Agios will use Commercially Reasonable Efforts to identify another [**] that will meet such guidelines and that is not already allocated to another Program. Any original [**] that is replaced as provided in this section shall become a Residual Program Compound.
Back-Up Compounds. At any time after acceptance of the first Candidate Compound pursuant to Section 2.5(a) and prior to final approval of an NDA or HRD for the first Licensed Product, Schering shall have the right to designate any Back-up Compound as a Licensed Product and Schering shall notify Corvas promptly thereof. Upon receipt by Corvas of such notice, such Back-up Compound shall become a Licensed Product and Exhibit D hereto shall be modified accordingly.
Back-Up Compounds. Subject to the terms and conditions of this Agreement, Corvas hereby grants to Schering an exclusive, even as to Corvas, license under the Corvas Patent Rights and Corvas Know-How, with the right to grant sublicenses, to make, use, offer for sale, import and export Back-up Compounds for all uses in the Territory. The license granted in this Section 3.1(b) shall expire when Back-up Compounds become Licensed Products in accordance with Section 2.5(b).
Back-Up Compounds. If, upon exercise of the Option with respect to a Dynavax Program, there are not [ * ] Back-up Compounds in such Dynavax Program that [ * ], then Dynavax shall continue, until [ * ] after GSK exercises such Option, to Develop [ * ] Back-up Compounds that [ * ] for such Dynavax Program, at Dynavax’s sole cost and responsibility. Such Back-up Compounds shall be subject to GSK’s Option and included within the applicable GSK Development Program. For clarity, efforts undertaken pursuant to this Section 5.2.1 following expiration of the Research Term shall not be deemed to extend the Research Term, but shall be subject to Dynavax’s obligation to use Commercially Reasonable Efforts.
Back-Up Compounds. Subject to Clause 4.7 with respect to Reserved Activities, Lilly may develop Back-up Compounds with respect to any Product at any time in accordance with a Co-Development Plan or Development Plan, as applicable. In the event that any such Back-up Compound becomes a Replacement Back-up Compound, then such Replacement Back-up Compound would, with respect to Development Milestones, “step-in” to the place of the Product it is replacing in accordance with Clause 13.4.2(e). Without limiting the foregoing, Lilly has no right to commercialize any Back-up Compound that is not a Replacement Back-up Compound; provided, that should Lilly desire to commercialize a Back-up Compound (other than a Replacement Back-up Compound), such commercialization shall be subject to negotiation of applicable financial terms under Clause 12.3.
Back-Up Compounds. CONFIDENTIAL TREATMENT REQUESTED The following provisions will apply with respect to Back-up Compounds to any Drug Product Candidate.
Back-Up Compounds. The payments set forth in Sections ------------------ 7.3.1
(a) and 7.3.2(a) above shall be made with respect to each Collaboration Compound (and corresponding Product). Notwithstanding the above, none of the milestone payments due pursuant to Sections 7.3.1(a) and 7.3.2
(a) above shall be paid with respect to any Active Compound or Other Compound, or any Derivative Compound of any of the foregoing, which is in active clinical development for any indication that is substantially the same as any indication for which a milestone-bearing Lead Compound is being developed, and where BMS' development plan for such Active Compound, Other Compound, or Derivative Compound specifically contemplates a halt in the development thereof if such Lead Compound is developed through NDA approval.
Back-Up Compounds. 3.9.1 When a Program Compound is nominated for EDC Status, the EDC Data Package shall identify other Program Compounds which shall serve as "Back-Up Compounds". Back-Up Compounds shall be identified by the Joint Research Committee based on back-up selection criteria agreed upon by the Joint Research Committee pursuant to 2.4.
3.9.2 Notwithstanding anything contained in this Agreement to the contrary, neither Party shall have the right to Develop as a Unilateral Development Compound any Back-Up Compound if the Parties are Developing or Commercializing one or more Joint Development Compounds or Joint Development Products which are Active against the same Program Target as such Back-Up Compound. In addition, neither Party may unilaterally Develop a Back-Up Compound [**] as an EDC Compound which is being Developed unilaterally by the other Party and which is Active against the same Program Target. Confidential Materials omitted and filed with the Securities and Exchange Commission. Asterisks denote omissions.
3.9.3 The selection of an EDC Compound as a Joint Development Compound or Unilateral Development Compound shall include Back-Up Compounds.
