Common use of Back-Up Compounds Clause in Contracts

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 throughout a period of [***] (ithe “Designation Period”) It is understood that and in accordance with the JRC (or provisions of Article 5.2 below, Helsinn shall have the JDC, as applicable) will identify right at its discretion to designate one of the Back-Up Compounds listed in the Back-Up Compounds Schedule as contemplated a replacement compound to be developed in place of ZP1846 (the “Designated Back-Up Compound”); provided, however, that: 2.5.1. HELSINN shall designate such Designated Back-Up Compound by Sections 1.7notice in writing to ZEALAND and from the date of such written notice (the “Designation Date”), 1.14(i) all references to the Compound contained in this Agreement shall be interpreted as referring to such Designated Back-Up Compound, 1.23(ii) this Agreement and the license granted under Article 2.1 of this Agreement shall terminate with regard to ZP1846 or the first Designated Back-Up Compound, 1.47as the case may be (while the license granted under Article 2.2 shall remain in full force and will continue to include any ZEALAND Know-How and ZEALAND Patents relevant to ZP1846 or the First Designated Back-Up Compound), (iii) the licenses granted to HELSINN with respect to the Compound in Article 2 above shall take effect with respect to the first or second Designated Back-Up Compound, as the case may be, and 1.98 (iv) the consequences provided for at Articles 13.1.1 and 13.1.2 shall apply with exclusive regard to ZP1846 or the first Designated Back-Up Compound; 2.5.2. HELSINN may not designate more than one compound as a Designated Back-Up Compound at any one time during the Designation Period; [***] Certain information in this document has been omitted and submitted separately to the Securities and Exchange Commission. Confidential treatment has been requested separately with respect to the omitted portions. 2.5.3. HELSINN may not designate more than two (2) compounds as Designated Back-Up Compounds during the Designation Period; 2.5.4. During the Designation Period, ZEALAND shall have the right to designate any compound included in the Back-Up Compounds Schedule as a compound that ZEALAND, directly or through its sub-licensees, intends in good faith to develop (a “ZEALAND Designated Compound”), provided, however, that: (i) at the time that ZEALAND designates such compound as a ZEALAND Designated Compound, it is not designated by HELSINN as a Designated Back-Up Compound, (ii) at all times during the Designation Period there shall be at least two/third of the compounds in the Back-Up Compound Schedule 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 have not been designated as ZEALAND Designated Compounds, (iii) once a Back-Up Compound in has been designated as a ProgramZEALAND Designated Compound, such Collaboration ZEALAND Designated Compound can only shall be so designated if it has not previously been allocated deemed to another Program or if be deleted from 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 Compounds Schedule and be removed from the scope of Agios’ Development responsibilities, upon Celgene’s written request at any time following IND Acceptance for this Agreement and HELSINN may not designate it as 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 Designated 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.