Cost Overruns. (i) Each Party shall promptly inform the other Party if such Party determines that it is likely to overspend or underspend by more than [***] percent ([***]%) its respective aggregate budgeted costs and expenses under the Joint Exploratory Development Plan or any Joint Plan for Development activities conducted thereunder and shall provide the other Party with a reasonably detailed explanation for such anticipated overspend or underspend. If the Parties agree, the budget set forth in the Joint Exploratory Development Plan or any Joint Plan for Development activities may be amended to address such overspend or underspend. (ii) The portion of any overspend that is less than or equal to [***] percent ([***]%) of a Party’s respective aggregate budgeted costs and expenses set forth in the Joint Exploratory Development Plan or such Joint Plan, as applicable, shall be included in Development Costs and shared by the Parties in accordance with the terms hereof. (iii) If a Party exceeds its aggregate budgeted costs and expenses by more than [***] percent ([***]%), the Party that has so exceeded its budget shall provide to the JEC a full explanation for exceeding such aggregate budgeted costs under the Joint Exploratory Development Plan or such Joint Plan, as applicable. If and to the extent that any such overspend in excess of [***] percent ([***]%) was outside the reasonable control of the applicable Party and not caused by the negligence or willful misconduct of, or breach of this Agreement by, such Party, then provided that the applicable Party has promptly notified the other Party of such overspend and used reasonable efforts to mitigate the size of such overspend, such overspend shall be included in Development Costs and shared by the Parties in accordance with the terms hereof. (iv) To the extent that any overspend is not included in Development Costs as provided in Section 11.2(b)(iii), the Party that has exceeded its budget shall be solely responsible for the overspend.
Appears in 2 contracts
Sources: Collaboration Agreement (Reata Pharmaceuticals Inc), Collaboration Agreement (Reata Pharmaceuticals Inc)
Cost Overruns. (ia) Each In any Calendar Year, each Party shall promptly inform the other Party if upon such Party determines determining that it is likely to overspend or underspend by more than [***] ten percent ([***]10%) its respective aggregate budgeted costs and expenses under the Joint Exploratory Development Plan or any Joint Plan for Development activities conducted thereunder and shall provide the other Party with a reasonably detailed explanation for such anticipated overspend or underspend. If the Parties agree, the budget total Collaboration Costs set forth in the Joint Exploratory Development Plan or any Joint Plan Budget for Development activities may be amended to address such overspend or underspendthat Calendar Year.
(ii) The portion of any overspend that is less than or equal to [***] percent ([***]%) of a Party’s respective aggregate budgeted costs and expenses set forth in the Joint Exploratory Development Plan or such Joint Plan, as applicable, shall be included in Development Costs and shared by the Parties in accordance with the terms hereof.
(iiib) If in any such Calendar Year a Party exceeds its aggregate budgeted costs and expenses by more than [***] ten percent ([***]10%), the Party that has so exceeded its budget shall provide to the JDC and to the JEC (if the matter is escalated to the JEC because it cannot be resolved by the JDC) a full explanation for exceeding such aggregate budgeted costs under the Joint Exploratory Development Plan or such Joint Plan, as applicableBudget. If and to the extent that any such overspend in excess of [***] percent ([***]%i) was outside the reasonable control of the applicable Party and not caused by the negligence or willful misconduct ofParty, or breach (ii) resulted from a reasonable or necessary acceleration of this Agreement byDevelopment activities within a particular Calendar Year, such Partysome or all of which activities had been expected to occur in a subsequent Calendar Year; then (in each case (i) and (ii)), then provided that the applicable Party has promptly notified the other Party of such overspend and and, in the case of overspends covered by clause (i) of this Section 2.3.2(b), used reasonable efforts to mitigate the size of such overspend, then such overspend shall be included in Development Collaboration Costs and shared by the Parties in accordance with the terms hereofpursuant to Section 6.1.1.
(ivc) To the extent that any overspend is not included in Development Collaboration Costs as provided in this Section 11.2(b)(iii)2.3.2, the Party that has exceeded its budget by more than ten percent (10%) for a Calendar Year shall be solely responsible for the overspend.
Appears in 2 contracts
Sources: Co Development and License Agreement (GPC Biotech Ag), Co Development and License Agreement (Pharmion Corp)
Cost Overruns. (ia) Each In any Calendar Year, each Party shall promptly inform the other Party if upon such Party determines determining that it is likely to overspend or underspend by more than [***] ten percent ([***]10%) its respective aggregate budgeted costs and expenses under the Joint Exploratory Development Plan or any Joint Plan for Development activities conducted thereunder and shall provide the other Party with a reasonably detailed explanation for such anticipated overspend or underspend. If the Parties agree, the budget total Collaboration Costs set forth in the Joint Exploratory Development Plan or any Joint Plan Commercialization Budget for Development activities may be amended to address such overspend or underspendthat Calendar Year.
(ii) The portion of any overspend that is less than or equal to [***] percent ([***]%) of a Party’s respective aggregate budgeted costs and expenses set forth in the Joint Exploratory Development Plan or such Joint Plan, as applicable, shall be included in Development Costs and shared by the Parties in accordance with the terms hereof.
(iiib) If in any such Calendar Year a Party exceeds its aggregate budgeted costs and expenses by more than [***] ten percent ([***]10%), the Party that has so exceeded its budget shall provide to the JCC and to the JEC (if the matter is escalated to the JEC because it cannot be resolved by the JCC) a full explanation for exceeding such aggregate budgeted costs under the Joint Exploratory Development Plan or such Joint Plan, as applicableCommercialization Budget. If and to the extent that any such overspend in excess of [***] percent ([***]%i) was outside the reasonable control of the applicable Party and not caused by the negligence or willful misconduct ofParty, or breach (ii) resulted from a reasonable or necessary acceleration of this Agreement byJoint Commercialization Activities within a particular Calendar Year, such Partysome or all of which activities had been expected to occur in a subsequent Calendar Year; then (in each case (i) and (ii)), then provided that the applicable Party has promptly notified the other Party of such overspend and and, in the case of overspends covered by clause (i) of this Section 3.10.2(b), used reasonable efforts to mitigate the size of such overspend, such overspend shall be included in Development Collaboration Costs and shared by the Parties in accordance with the terms hereofpursuant to Section 6.1.1.
(ivc) To the extent that any overspend is not included in Development Collaboration Costs as provided in this Section 11.2(b)(iii)3.10.2, the Party that has exceeded its budget by more than ten percent (10%) for a Calendar Year shall be solely responsible for the overspend.
Appears in 2 contracts
Sources: Co Development and License Agreement (GPC Biotech Ag), Co Development and License Agreement (Pharmion Corp)
Cost Overruns. (i) Each Party shall promptly inform the other Party if JDC upon such Party determines Party’s determining that it is likely to overspend or underspend by more than [***] percent ([***]%) its respective aggregate budgeted costs and expenses under the Joint Exploratory Development Plan or any Joint Plan for Development activities conducted thereunder and shall provide the other Party with a reasonably detailed explanation for such anticipated overspend or underspend. If the Parties agree, the budget set forth in the Joint Exploratory Development Plan or any Joint Plan for Development activities may be amended to address such overspend or underspend.
(ii) The portion of any overspend that is less than or equal to [***] percent ([***]%) of a Party’s respective aggregate budgeted costs and expenses set forth in the Joint Exploratory a Development Plan for any Calendar Year with respect to any clinical trials or other development work for which it is the Responsible Party (such Joint Planoverspend, as applicable, a “Cost Overrun”) and the JDC shall be included promptly hold an ad-hoc meeting and shall discuss reasonably and in Development Costs and shared by good faith what steps to take to address the Parties in accordance with Cost Overrun (which may include modifying the terms hereof.
(iii) If a Party exceeds its aggregate budgeted costs and expenses by more than [***] percent ([***]%), the Party that has so exceeded its budget shall provide to the JEC a full explanation for exceeding such aggregate budgeted costs under the Joint Exploratory Development Plan to reduce the costs appropriately or increasing the budget for such Joint Plan, as applicableclinical trial or other development work so that there is no longer a Cost Overrun). If and to To the extent that any such overspend in excess anticipated Cost Overrun is caused by matters outside of [***] percent ([***]%) was outside the such Responsible Party’s reasonable control (including, for example, changes in circumstances, regulatory delays, inaccuracies in the original development budget for the tasks or in the assumptions on which the budget was based), then such Responsible Party shall also include in its notice to the JDC of such Cost Overrun, the cause(s) of such anticipated Cost Overrun, and the JDC shall discuss such budget issue in good faith and seek to modify the applicable Party and not caused Development Plan in a manner so that there is no longer a Cost Overrun. Any resulting modifications to the applicable budget in a Development Plan approved by the negligence or willful misconduct of, or breach of this Agreement by, such Party, then provided that the applicable Party has promptly notified the other Party of such overspend and used reasonable efforts JDC to mitigate the size of such overspend, such overspend address a Cost Overrun shall be included as an amendment to the budget in such Development Costs Plan. Each Party shall not knowingly perform, and shared shall not have the obligation to perform, any clinical trials or development work that likely will result in a Cost Overrun until such issue and related expenditure have been reviewed and approved by the Parties JDC; provided that if a Party determines after commencing an activity that cannot reasonably be ceased (such as an ongoing clinical trial that cannot be interrupted without jeopardizing the well-being of any subject in accordance with such clinical trial or the terms hereof.
(iv) To the extent that any overspend is not included in Development Costs as provided in Section 11.2(b)(iiitiming or integrity of such trial), that a Cost Overrun is likely for such activity, such Party shall have the Party that has exceeded its budget right to continue such activity upon notice to the JDC, and the JDC shall be solely responsible for the overspendattempt in good faith to address such Cost Overrun as soon as reasonably practicable.
Appears in 1 contract
Sources: Marketing and Supply Agreement (Arena Pharmaceuticals Inc)
Cost Overruns. (i) Each Party shall promptly inform the other Party if JDC upon such Party determines Party’s determining that it is likely to overspend or underspend by more than [***] percent ([***]%) its respective aggregate budgeted costs and expenses under the Joint Exploratory Development Plan or any Joint Plan for Development activities conducted thereunder and shall provide the other Party with a reasonably detailed explanation for such anticipated overspend or underspend. If the Parties agree, the budget set forth in the Joint Exploratory Development Plan or any Joint Plan for Development activities may be amended to address such overspend or underspend.
(ii) The portion of any overspend that is less than or equal to [***] percent ([***]%) of a Party’s respective aggregate budgeted costs and expenses set forth in the Joint Exploratory a Development Plan for any Calendar Year with respect to any clinical trials or other development work for which it is the Responsible Party (such Joint Planoverspend, as applicable, a “Cost Overrun”) and the JDC shall be included promptly hold an an-hoc meeting and shall discuss reasonably and in Development Costs and shared by good faith what steps to take to address the Parties in accordance with Cost Overrun (which may include modifying the terms hereof.
(iii) If a Party exceeds its aggregate budgeted costs and expenses by more than [***] percent ([***]%), the Party that has so exceeded its budget shall provide to the JEC a full explanation for exceeding such aggregate budgeted costs under the Joint Exploratory Development Plan to reduce the costs appropriately or increasing the budget for such Joint Plan, as applicableclinical trial or other development work so that there is no longer a Cost Overrun). If and to To the extent that any such overspend in excess anticipated Cost Overrun is caused by matters outside of [***] percent ([***]%) was outside the such Responsible Party’s reasonable control (including, for example, changes in circumstances, regulatory delays, inaccuracies in the original development budget for the tasks or in the assumptions on which the budget was based), then such Responsible Party shall also include in its notice to the JDC of such Cost Overrun, the cause(s) of such anticipated Cost Overrun, and the JDC shall discuss such budget issue in good faith and seek to modify the applicable Party and not caused Development Plan in a manner so that there is no longer a Cost Overrun. Any resulting modifications to the applicable budget in a Development Plan approved by the negligence or willful misconduct of, or breach of this Agreement by, such Party, then provided that the applicable Party has promptly notified the other Party of such overspend and used reasonable efforts JDC to mitigate the size of such overspend, such overspend address a Cost Overrun shall be included as an amendment to the budget in such Development Costs Plan. Each Party shall not knowingly perform, and shared shall not have the obligation to perform, any clinical trials or development work that likely will result in a Cost Overrun until such issue and related expenditure have been reviewed and approved by the Parties JDC; provided that if a Party determines after commencing an activity that cannot reasonably be ceased (such as an ongoing clinical trial that cannot be interrupted without jeopardizing the well-being of any subject in accordance with such clinical trial or the terms hereof.
(iv) To the extent that any overspend is not included in Development Costs as provided in Section 11.2(b)(iiitiming or integrity of such trial), that a Cost Overrun is likely for such activity, such Party shall have the Party that has exceeded its budget right to continue such activity upon notice to the JDC, and the JDC shall be solely responsible for the overspendattempt in good faith to address such Cost Overrun as soon as reasonably practicable.
Appears in 1 contract
Sources: Marketing and Supply Agreement (Arena Pharmaceuticals Inc)
Cost Overruns. (i) Each Party shall promptly inform the other Party if upon such Party determines determining that it is likely to overspend or underspend by more than [***] ten percent ([***]10%) its respective aggregate budgeted costs and expenses under for Initial Development Activities or Joint Development Activities, as the Joint Exploratory Development Plan or any Joint Plan for Development activities conducted thereunder and shall provide the other Party with a reasonably detailed explanation for such anticipated overspend or underspend. If the Parties agreecase may be, the budget set forth in the Joint Exploratory each applicable Development Plan or any Joint Plan for Development activities may be amended to address such overspend or underspendand Budget.
(ii) The portion of any overspend that is less than or equal to [***] ten percent ([***]10%) of a Party’s respective aggregate budgeted costs and expenses for Initial Development Activities or Joint Development Activities, as the case may be, set forth in the Joint Exploratory an applicable Development Plan or such Joint Plan, as applicable, and Budget shall be included in Development Collaboration Costs and shared by the Parties pursuant to Section 3.4.1. Specific terms in accordance this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with the terms hereofthree asterisks [***].
(iii) If a Party exceeds its aggregate budgeted costs and expenses by more than [***] ten percent ([***]10%), the Party that has so exceeded its budget shall provide to the JEC JDC a full explanation for exceeding such aggregate budgeted costs under the Joint Exploratory applicable Development Plan or such Joint Plan, as applicableand Budget. If and to the extent that any such overspend in excess of [***] ten percent ([***]10%) was outside the reasonable control of the applicable Party and not caused by the negligence or willful wilful misconduct of, or breach of this Agreement by, such Party, then provided that the applicable Party has promptly notified the other Party of such overspend and used reasonable efforts to mitigate the size of such overspend, such overspend shall be included in Development Collaboration Costs and shared by the Parties in accordance with the terms hereofpursuant to Section 3.4.1.
(iv) To the extent that any overspend is not included in Development Collaboration Costs as provided in Section 11.2(b)(iii3.4.4(ii) or 3.4.4(iii), the Party that has exceeded its budget shall be solely responsible for the overspend.
Appears in 1 contract
Cost Overruns. (i) Each Party shall promptly inform the other Party if upon such Party determines determining that it is likely to overspend or underspend by more than [***] percent ([***]%) its respective aggregate budgeted costs and expenses under for Initial Development Activities or Joint Development Activities, as the Joint Exploratory Development Plan or any Joint Plan for Development activities conducted thereunder and shall provide the other Party with a reasonably detailed explanation for such anticipated overspend or underspend. If the Parties agreecase may be, the budget set forth in the Joint Exploratory each applicable Development Plan or any Joint Plan for Development activities may be amended to address such overspend or underspendand Budget.
(ii) The portion of any overspend that is less than or equal to [***] percent ([***]%) percent of a Party’s respective aggregate budgeted costs and expenses for Initial Development Activities or Joint Development Activities, as the case may be, set forth in the Joint Exploratory an applicable Development Plan or such Joint Plan, as applicable, and Budget shall be included in Development Collaboration Costs and shared by the Parties in accordance with the terms hereofpursuant to Section 3.4.1.
(iii) If a Party exceeds its aggregate budgeted costs and expenses by more than [***] percent ([***]%), ) the Party that has so exceeded its budget shall provide to the JEC JDC a full explanation for exceeding such aggregate budgeted costs under the Joint Exploratory applicable Development Plan or such Joint Plan, as applicableand Budget. If and to the extent that any such overspend in excess of [***] percent ([***]%) was outside the reasonable control of the applicable Party and not caused by the negligence or willful wilful misconduct of, or breach of this Agreement by, such Party, then provided that the applicable Party has promptly notified the other Party of such overspend and used reasonable efforts to mitigate the size of such overspend, such overspend shall be included in Development Collaboration Costs and shared by the Parties in accordance with the terms hereofpursuant to Section 3.4.1.
(iv) To the extent that any overspend is not included in Development Collaboration Costs as provided in Section 11.2(b)(iii3.4.4(ii) or 3.4.4(iii), the Party that has exceeded its budget shall be solely responsible for the overspend.
Appears in 1 contract
Cost Overruns. (i) Each Party With respect to the Product, each Party, through the JUSLT, shall promptly inform notify the other Party if upon becoming aware that its Program Costs to be incurred in Amgen Ref. No. 2017747574 Page 18 performing the applicable Commercialization Plan for a Calendar Year will be in excess of the amounts budgeted to be incurred by or on behalf of such Party determines for its Commercialization activities in the applicable budget. If the applicable Program Costs incurred by a Party for performing the applicable Commercialization Plan for a Calendar Year exceed the amounts budgeted to be incurred by or on behalf of such Party for its Commercialization activities in the applicable budget, the other Party shall reimburse the performing Party for the applicable percentage set forth above of such excess; provided that it is likely in no event shall either Party be responsible for reimbursement for such excesses to overspend the extent the Program Costs of the other Party in performing the Commercialization Plan for a Calendar Year exceed the amounts budgeted to be incurred by or underspend on behalf of such other Party for its Commercialization activities in the applicable budget by more than [***] percent ([***]%) its respective aggregate budgeted costs and expenses under the Joint Exploratory Development Plan or any Joint Plan ); provided that a Party shall be responsible for Development activities conducted thereunder and shall provide the other Party with a reasonably detailed explanation reimbursement for such anticipated overspend or underspend. If excesses to the Parties agree, extent the budget set forth applicable Program Costs are attributable to (i) a change in the Joint Exploratory Development Plan or any Joint Plan for Development activities may be amended to address such overspend or underspend.
applicable Law; (ii) The portion of any overspend that is less than a Force Majeure event; or equal to [***] percent ([***]%) of a Party’s respective aggregate budgeted costs and expenses set forth in the Joint Exploratory Development Plan or such Joint Plan, as applicable, shall be included in Development Costs and shared by the Parties in accordance with the terms hereof.
(iii) If a Party exceeds its aggregate budgeted costs and expenses by more than [***] percent ([***]%), the Party that has so exceeded its budget shall provide mutually agreed amendment to the JEC a full explanation for exceeding such aggregate budgeted costs under the Joint Exploratory Development Plan or such Joint applicable Commercialization Plan, as applicable. If and to the extent that any such overspend in excess of [***] percent ([***]%) was outside the reasonable control of the applicable Party and not caused by the negligence or willful misconduct of, or breach of this Agreement by, such Party, then provided that the applicable Party has promptly notified the other Party of such overspend and used reasonable efforts to mitigate the size of such overspend, such overspend shall be included in Development Costs and shared by the Parties in accordance with the terms hereof.
(iv) To the extent that any overspend is not included in Development Costs as provided in Section 11.2(b)(iii), the Party that has exceeded its budget shall be solely responsible for the overspend.
Appears in 1 contract
Sources: Collaboration Agreement (Amgen Inc)