Common use of Development Costs Clause in Contracts

Development Costs. (a) On a quarterly basis for each Research Program, Spyre will advance to Paragon any Development Costs contemplated in the Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of the Research Program during the upcoming [***] (less any pre-payments for Third Party Costs from earlier [***] that Paragon reasonably anticipates will be carried over to such upcoming [***]) (the “Cost Advance”). Spyre will pay the Cost Advance within [***] days after receipt of Paragon’s invoice for such Development Costs. The Parties acknowledge that Paragon has incurred approximately $10,000,000 in Development Costs prior to the Effective Date, as a result of work performed by Paragon at risk on one or more Research Programs (the “Pre-Effective Date Development Costs”), which amount includes for Research Initiation Fees of $3,000,000 for a total of four Research Programs. Spyre shall reimburse Paragon for the Pre-Effective Date Development Costs no later than [***] days after the later of (i) the Effective Date and (ii) Spyre’s receipt of a written invoice that details the Pre-Effective Date Development Costs and includes reasonable documentation therefor. (b) Within [***] after the end of each Calendar Year, Paragon will calculate and provide to Spyre a written reconciliation of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Year (“Actual Annual Costs”) against that portion of the Cost Advance for such Third Party Costs for that Calendar Year, including reasonable documentation of such Actual Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs in the Cost Advance exceeds the Actual Annual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the Budget and reasonably expected to be incurred by Paragon in the performance of the Research Program during any upcoming Calendar Year and Spyre will deduct such amount from its next quarterly Cost Advance. If the Cost Advance is less than the Actual Annual Costs, then Paragon will invoice Spyre for the difference and Spyre will pay such amount together with its next quarterly Cost Advance. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Annual Development Fees.

Appears in 2 contracts

Sources: Antibody Discovery and Option Agreement (Spyre Therapeutics, Inc.), Antibody Discovery and Option Agreement (Aeglea BioTherapeutics, Inc.)

Development Costs. (a) On If ALZA elects to pay the Development Fee upon exercise of the Option in a quarterly basis for each Research Programlump sum payment, Spyre Alkermes will advance to Paragon any fund all Development Costs contemplated in up to the Budgetamount of the Development Fee. In connection therewith, including [***]Alkermes will reimburse ALZA, and any [***] reasonably expected on a monthly basis, all of ALZA's Development Costs of the Program for Subterritory A, until the amounts paid by Alkermes to be ALZA plus the amounts incurred by Paragon Alkermes, in each case, as Development Costs under the performance of Definitive Agreement, equal the Research Program during the upcoming [***] (less any pre-payments for Third Party Costs from earlier [***] that Paragon reasonably anticipates will be carried over Development Fee. If ALZA elects to such upcoming [***]) (the “Cost Advance”). Spyre will pay the Cost Advance within [***] days after receipt of Paragon’s invoice Anticipated Completion Costs on an ongoing basis, rather than paying the Development Fee, then ALZA will reimburse Alkermes, on a monthly basis, for such Development Costs. The Parties acknowledge that Paragon has incurred approximately $10,000,000 in Alkermes' Development Costs prior to duly incurred under the Effective DateDefinitive Agreement, as a result of work performed by Paragon at risk on one or more Research Programs (until the “Pre-Effective Date Development Costs”), which amount includes for Research Initiation Fees of $3,000,000 for a total of four Research Programs. Spyre shall reimburse Paragon for the Pre-Effective Date Development Costs no later than [***] days after for Subterritory A incurred by both parties under the later of (i) Definitive Agreement equal the Effective Date and (ii) Spyre’s receipt of a written invoice that details the Pre-Effective Date Development Costs and includes reasonable documentation therefor. (b) Within [***] after the end of each Calendar Year, Paragon will calculate and provide to Spyre a written reconciliation of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Year (“Actual Annual Anticipated Completion Costs”) against that portion of the Cost Advance for such Third Party Costs for that Calendar Year, including reasonable documentation of such Actual Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party total Development Costs of the Program in Subterritory A incurred by the Cost Advance exceeds parties under the Actual Annual Definitive Agreement and as approved by the Collaboration Committee exceed the Development Fee or the Anticipated Completion Costs, then Paragon as the case may be, the parties will credit such bear any excess payment against equally, on an ongoing basis, with appropriate monthly reimbursement. Development Costs contemplated in the Budget and reasonably expected to be incurred by Paragon in the performance for purposes of the Research Program during any upcoming Calendar Year and Spyre Definitive Agreement will deduct such amount from its next quarterly Cost Advancemean those costs approved in advance by the Collaboration Committee for expenditure. If the Cost Advance is less than the Actual Annual Costs, then Paragon will invoice Spyre for the difference and Spyre will pay such amount together with its next quarterly Cost AdvanceTHIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Annual Development FeesREDACTED MATERIAL IS MARKED WITH A *** AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

Appears in 1 contract

Sources: Clinical Collaboration and Option Agreement (Alkermes Inc)

Development Costs. (a) The monthly rate for the Development Fees (the “Monthly Rate”) shall be determined and charged on a Research Program-by-Research Program and calendar month-by-calendar month basis based on, with respect to any particular calendar month, the total number of Research Programs being conducted under this Agreement and each other similar Antibody Discovery and Option Agreement between Paragon and Parade, on the one hand, and Jade or any Affiliate of Jade, on the other hand (each such Research Program, an “Active Research Program”). For the period beginning on the Effective Date and continuing through December 31, 2024, the Monthly Rate for each Active Research Program in a particular calendar month shall be [***]. If a Research Plan requires Paragon to perform certain chemistry, manufacturing, and control activities (“CMC Activities”) in furtherance of the Research Program, then the Monthly Rate for such Research Program that would otherwise apply shall be [***]. Paragon shall have the right to adjust the Monthly Rate and the CMC Rate on an annual basis to account for inflation and other increases in costs by providing written notice thereof to Jade at least [***] prior to the commencement of each [***]. ​ (b) On a quarterly basis for each Research Programbasis, Spyre ▇▇▇▇ will advance to Paragon any Development Costs contemplated in the Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of the Research Program during the upcoming [***] in accordance with the Research Plan and Budget (less any pre-payments for Third Party Costs from earlier [***] that Paragon reasonably anticipates will be carried over to such upcoming [***]) (the “Cost Advance”). Spyre On a quarterly basis, Paragon will deliver an invoice to Jade for the Cost Advance, and ▇▇▇▇ will pay the Cost Advance within [***] days after receipt of Paragon’s invoice for such Development Costs. The Parties acknowledge that Paragon has incurred approximately $10,000,000 in Development Costs prior to the Effective Date, as a result of work performed by Paragon at risk on one or more Research Programs (the “Pre-Effective Date Development Costs”), which amount includes for Research Initiation Fees of $3,000,000 for a total of four Research Programs. Spyre shall reimburse Paragon for the Pre-Effective Date Development Costs no later than [***] days after the later of (i) the Effective Date and (ii) Spyre’s receipt of a written invoice that details the Pre-Effective Date Development Costs and includes reasonable documentation thereforinvoice. (bc) Within [***] after the end of each Calendar Year, Paragon will calculate and provide to Spyre ▇▇▇▇ a written reconciliation of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Year (“Actual Annual Costs”) against that portion of the Cost Advance for such Third Party Costs for that Calendar Year, including reasonable documentation of such Actual Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs in the Cost Advance exceeds the Actual Annual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the Budget and reasonably expected to be incurred by Paragon in the performance of the Research Program during any upcoming Calendar Year and Spyre Jade will deduct such amount from its next quarterly Cost Advance. If the Cost Advance is less than the Actual Annual Costs, then Paragon will invoice Spyre Jade for the difference and Spyre Jade will pay such amount together with its next quarterly Cost Advance. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Annual Development Fees. (d) Notwithstanding Sections 5.2(a), 5.2(b) and 5.2(c) to the contrary, the Parties acknowledge that Paragon has incurred (i) approximately $5,611,515.00 in Development Costs through June 30, 2024, and (ii) certain additional Development Costs between July 1, 2024 and the Effective Date, as a result of work performed by Paragon at risk on the Research Program for APRIL (the costs described in (i) and (ii), the “Pre-Effective Date Development Costs”). ▇▇▇▇ shall reimburse Paragon for the Pre-Effective Date Development Costs within [***] after ▇▇▇▇’s receipt of a written invoice that details the Pre-Effective Date Development Costs.

Appears in 1 contract

Sources: Antibody Discovery and Option Agreement (Aerovate Therapeutics, Inc.)

Development Costs. (a) On a quarterly basis for Within [*] days following the end of each Research Program, Spyre will advance to Paragon any calendar quarter in which the Parties incur Development Costs contemplated that are subject to the cost-sharing provisions of Sections 3.10 and/or 4.8, each Party shall provide to the other Party a written report, in reasonable detail, of the Budget, including [***]estimated Development Costs (excluding any Pre-IND Cost Share amount under Section 4.8(b)(i)) subject to such cost-sharing provisions incurred by such Party during such calendar quarter, and any [***] reasonably expected then shall provide to be incurred by Paragon in the performance other Party a final report of the Research Program during the upcoming [***] (less any pre-payments for Third Party such Development Costs from earlier [***] that Paragon reasonably anticipates will be carried over to such upcoming [***]) (the “Cost Advance”). Spyre will pay the Cost Advance within [**] days following the end of each calendar quarter. CVT shall reimburse PTC for [*] days after receipt percent ([*] %) of ParagonPTC’s Development Costs incurred during the calendar quarter with respect to PTC’s activities. PTC shall invoice CVT for such Development Costs. The Parties acknowledge that Paragon has incurred approximately $10,000,000 in PTC Development Costs prior to the Effective Date, as a result of work performed by Paragon at risk on one or more Research Programs (the “Pre-Effective Date Development Costs”), which amount includes for Research Initiation Fees of $3,000,000 for a total of four Research Programs. Spyre shall reimburse Paragon for the Pre-Effective Date Development Costs no later than within [***] days after the later end of (i) the Effective Date and (ii) Spyre’s receipt of a written invoice that details the Pre-Effective Date Development Costs and includes reasonable documentation therefor. (b) Within each calendar quarter. CVT shall pay all such invoices within [***] days after the end of each Calendar Yearsuch calendar quarter. PTC shall reimburse CVT for [*] percent ([*] %) of CVT’s Development Costs incurred during the calendar quarter with respect to CVT’s activities. CVT shall invoice PTC for such CVT Development Costs within [*] days after the end of each calendar quarter. PTC shall pay all such invoices within [*] days after the end of each such calendar quarter; provided, Paragon will calculate and provide however, that following PTC’s exercise of an Opt-In Right, PTC shall have the right upon written notice to Spyre a written reconciliation CVT to delay payment of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Year (“Actual Annual Costs”) against that portion of any invoice in excess of [*] percent ([*] %) of the Cost Advance budget (as such budget may be adjusted from time to time pursuant to the terms of this Agreement) for Development Costs for the applicable calendar quarter, with such cumulative delayed amount (the “Excess Amount”) to be added to invoices for subsequent calendar quarters up to the [*] percent ([*] %) budget threshold for such Third Party Costs subsequent quarters until the earlier of when the Excess Amount is fully paid by PTC or the last quarter for which the applicable program continues and a budget exists; provided that, in the case where a program has terminated and no budget exists, any remaining Excess Amount shall be paid by PTC to CVT in six (6) equal quarterly installments such that Calendar Year, including reasonable documentation the entire Excess Amount is paid at the end of the sixth (6th) calendar quarter after the calendar quarter following termination of such Actual Annual Costs. The form program and for which no budget existed; and provided further, that upon the occurrence of a milestone payment under Section 5.4 for the applicable Collaboration Compound or Licensed Products (but not otherwise), CVT shall deduct from the amount of such reconciliation milestone payment owed to PTC, the remaining Excess Amount owed by PTC; and provided further, that if upon the occurrence of a milestone payment under Section 5.4, the remaining Excess Amount owed by PTC is greater than such milestone payment, no such milestone payment shall be subject owed by CVT, and PTC shall pay to JDC review CVT the difference between the remaining Excess Amount and approval. If the amounts paid for anticipated Third Party Costs in the Cost Advance exceeds the Actual Annual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the Budget and reasonably expected to be incurred by Paragon in the performance amount of the Research Program during any upcoming Calendar Year milestone that would have been owed by CVT. [*] Certain information on this page has been redacted and Spyre will deduct such amount from its next quarterly Cost Advancefiled separately with the Securities and Exchange Commission. If Confidential treatment has been requested with respect to the Cost Advance is less than the Actual Annual Costs, then Paragon will invoice Spyre for the difference and Spyre will pay such amount together with its next quarterly Cost Advance. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Annual Development Feesomitted portions.

Appears in 1 contract

Sources: Collaboration and License Agreement (Cv Therapeutics Inc)

Development Costs. (a) The monthly rate for the Development Fees (the “Monthly Rate”) shall be determined and charged on a calendar month-by-calendar month basis. For the period beginning on the Effective Date and continuing through December 31, 2024, the Monthly Rate shall be [***]. If the Research Plan requires Paragon to perform certain chemistry, manufacturing, and control activities (“CMC Activities”) in furtherance of the Research Program, then the Monthly Rate that would otherwise apply shall be [***]. Paragon shall have the right to adjust the Monthly Rate and the CMC Rate on an annual basis to account for inflation and other increases in costs by providing written notice thereof to Crescent at least [***] prior to the commencement of each [***]. (b) On a quarterly basis for each Research Programbasis, Spyre Crescent will advance to Paragon any Development Costs contemplated in the Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of the Research Program during the upcoming [***] in accordance with the Research Plan and Budget (less any pre-payments for Third Party Costs from earlier [***] that Paragon reasonably anticipates will be carried over to such upcoming [***]) (the “Cost Advance”). Spyre On a quarterly basis, Paragon will deliver an invoice to Crescent for the Cost Advance, and Crescent will pay the Cost Advance within [***] days after receipt of Paragon’s invoice for such Development Costs. The Parties acknowledge that Paragon has incurred approximately $10,000,000 in Development Costs prior to the Effective Date, as a result of work performed by Paragon at risk on one or more Research Programs (the “Pre-Effective Date Development Costs”), which amount includes for Research Initiation Fees of $3,000,000 for a total of four Research Programs. Spyre shall reimburse Paragon for the Pre-Effective Date Development Costs no later than [***] days after the later of (i) the Effective Date and (ii) Spyre’s receipt of a written invoice that details the Pre-Effective Date Development Costs and includes reasonable documentation thereforinvoice. (bc) Within [***] after the end of each Calendar Year, Paragon will calculate and provide to Spyre Crescent a written reconciliation of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Year (“Actual Annual Costs”) against that portion of the Cost Advance for such Third Party Costs for that Calendar Year, including reasonable documentation of such Actual Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs in the Cost Advance exceeds the Actual Annual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the Budget and reasonably expected to be incurred by Paragon in the performance of the Research Program during any upcoming Calendar Year and Spyre Crescent will deduct such amount from its next quarterly Cost Advance. If the Cost Advance is less than the Actual Annual Costs, then Paragon will invoice Spyre Crescent for the difference and Spyre Crescent will pay such amount together with its next quarterly Cost Advance. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Annual Development Fees. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) IS THE TYPE OF INFORMATION THAT THE REGISTRANT BOTH CUSTOMARILY AND ACTUALLY TREATS AS PRIVATE AND CONFIDENTIAL. (d) Notwithstanding Sections 5.2(a), 5.2(b) and 5.2(c) to the contrary, the Parties acknowledge that Paragon has incurred certain Development Costs between October 1, 2024 and the Effective Date, as a result of work performed by Paragon at risk on the Research Program (the costs described in (i) and (ii), the “Pre-Effective Date Development Costs”). Crescent shall reimburse Paragon for the Pre-Effective Date Development Costs within [***] after Crescent’s receipt of a written invoice that details the Pre-Effective Date Development Costs.

Appears in 1 contract

Sources: Adc Discovery and Option Agreement (Glycomimetics Inc)

Development Costs. (a) On a quarterly basis for each Research Program, Spyre will advance to Paragon any Development Costs contemplated in the Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of the Research Program during the upcoming [***] (less any pre-payments for Third Party Costs [***] from earlier [***] that Paragon reasonably anticipates will be carried over to such upcoming [***]] ) (the “Cost Advance”). Spyre will pay the Cost Advance within [***] days after receipt of Paragon’s invoice for such Development Costs. The Parties acknowledge that Paragon has incurred approximately $10,000,000 in Development Costs prior to the Effective Date, as a result of work performed by Paragon at risk on one or more Research Programs (the “Pre-Effective Date Development Costs”), which amount includes for Research Initiation Fees of $3,000,000 for a total of four Research Programs. Spyre shall reimburse Paragon for the Pre-Effective Date Development Costs no later than [***] days after the later of (i) the Effective Date and (ii) Spyre’s receipt of a written invoice that details the Pre-Effective Date Development Costs and includes reasonable documentation therefor. (b) Within [***] days after the end of each Calendar Year, Paragon will calculate and provide to Spyre a written reconciliation of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Year (“Actual Annual Costs”) against that portion of the Cost Advance for such Third Party Costs for that Calendar Year, including reasonable documentation of such Actual Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs in the Cost Advance exceeds the Actual Annual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the Budget and reasonably expected to be incurred by Paragon in the performance of the Research Program during any upcoming Calendar Year and Spyre will deduct such amount from its next quarterly Cost Advance. If the Cost Advance is less than the Actual Annual Costs, then Paragon will invoice Spyre for the difference and Spyre will pay such amount together with its next quarterly Cost Advance. If no further amounts will be owed to Paragon hereunder, P▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Annual Development Fees.

Appears in 1 contract

Sources: Antibody Discovery and Option Agreement (Aeglea BioTherapeutics, Inc.)

Development Costs. (ai) On a quarterly basis for each Research ProgramSchering-Plough shall fund, Spyre will advance to Paragon any in accordance with Section 7.4, all Development Costs contemplated in incurred by AVEO after the BudgetEffective Date pursuant to the Joint Development Plan (including any budgets attached to or associated with the Joint Development Plan). Such Development Costs shall include, including without limitation, all amounts (other than royalties on the sales of products) payable by AVEO pursuant to [***], and any [***] reasonably expected to be incurred by Paragon in the performance of the Research Program during the upcoming [***] (less any pre-payments for Third Party Costs from earlier [***] that Paragon reasonably anticipates will be carried over to such upcoming [***]) (the “Cost Advance”). Spyre will pay the Cost Advance within [***] days after receipt of Paragon’s invoice for such Development Costs. The Parties acknowledge that Paragon has incurred approximately $10,000,000 in Development Costs prior to the Effective Date, as a result of work performed by Paragon at risk on one or more Research Programs (the “Pre-Effective Date Development Costs”), which amount includes for Research Initiation Fees of $3,000,000 for a total of four Research Programs. Spyre shall reimburse Paragon for the Pre-Effective Date Development Costs no later than [***] days after the later of (i) the Effective Date and . (ii) Spyre’s receipt The amount and timing of a written invoice that details the Pre-Effective Date first payment of Development Costs under this Agreement shall be determined by the JSC according to the Joint Development Plan and includes reasonable documentation thereforshall cover the first full Calendar Quarter of activities conducted under the Joint Development Plan, along with the prorated portion of the Calendar Quarter in which activities under the Joint Development Plan begin. Such first payment shall be made within ten (10) Business Days after commencement of the Development Term. (biii) Within [**] Business Days after the end of each month during the Development Term, AVEO shall provide Schering-Plough with a detailed statement of its Development Costs for the month just ended, setting out the Development Costs actually incurred by AVEO. Such statement shall include, but not be limited to, [**]. (iv) Within [**] Business Days after the end of each Calendar YearQuarter during the Development Term, Paragon will calculate and AVEO shall provide to Spyre Schering-Plough with a written reconciliation reasonably detailed statement of its actually-Development Costs for the Calendar Quarter just ended, setting out the Development Costs actually incurred Third Party by AVEO. Such statement shall include, but not be limited to, [**]. If the actual Development Costs (incurred by AVEO in performing its obligations under the Joint Development Plan in a manner consistent with Calendar Quarter are greater than the Budget) for the prior Calendar Year (“Actual Annual Costs”) against that portion of the Cost Advance for such Third Party Costs advance payment made by Schering-Plough for that Calendar YearQuarter (as shown by the statements of expenditure for the Calendar Quarter in question), including reasonable documentation AVEO shall add such amount to its next quarterly invoice for Development Costs to be issued and Schering-Plough shall pay such additional amount to AVEO as part of the forthcoming payment to reconcile such Actual Annual Costsshortfall. The form If at the end of the Development Term there are outstanding Development Costs owing to AVEO, AVEO shall invoice Schering-Plough for such reconciliation shall be subject to JDC review and approvalamount when it submits its detailed statement of expenditure for the final month of the Development Term. If the amounts paid actual Development Costs incurred by AVEO in a Calendar Quarter in performing its obligations under the Joint Development Plan (as shown by the statements of expenditure for anticipated Third Party the Calendar Quarter in question), are less than the advance payment made by Schering-Plough for that Calendar Quarter pursuant to Section 7.4, AVEO shall credit Schering-Plough against AVEO’s future Development Costs for the sum of such overpayment and shall show such credit on its next invoice for Development Costs. However, in the Cost Advance exceeds the Actual Annual Costs, then Paragon will credit such excess payment against Development Costs contemplated event that there has been an overpayment in the Budget final Calendar Quarter of the Development Term, AVEO shall reimburse Schering-Plough for such overpayment within thirty (30) days after Schering-Plough receives the statement of expenditure for the final month of the Development Term. (v) Except as expressly set forth in this Agreement, each of Schering-Plough and reasonably expected to AVEO shall be incurred by Paragon solely responsible for its own out-of-pocket costs and disbursements incurred, and for providing the necessary facilities, supplies, personnel and other resources necessary, in the performance of the Research Program during any upcoming Calendar Year and Spyre will deduct such amount from its next quarterly Cost Advance. If the Cost Advance is less than the Actual Annual Costs, then Paragon will invoice Spyre for the difference and Spyre will pay such amount together with its next quarterly Cost Advance. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Annual Development Feesobligations under this Agreement.

Appears in 1 contract

Sources: Research, Development and License Agreement (Aveo Pharmaceuticals Inc)

Development Costs. (a) On a quarterly basis for each Research Program, Spyre Apogee will advance to Paragon any Development Costs contemplated in the Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of the Research Program during the upcoming [***] (less any pre-payments for Third Party Costs [***] from earlier [***] that Paragon reasonably anticipates will be carried over to such upcoming [***]] ) (the “Cost Advance”). Spyre Apogee will pay the Cost Advance within [***] days after receipt of Paragon’s invoice for such Development Costs. The Parties acknowledge that Paragon has incurred approximately $10,000,000 1,254,000 in Development Costs prior to the Effective Date, as a result of work performed by Paragon at risk on one or more Research Programs (the “Pre-Effective Date Development Costs”), which amount includes for Research Initiation Fees of $3,000,000 for a total of four Research Programs. Spyre Apogee shall reimburse Paragon for the Pre-Effective Date Development Costs no later than [***] days after the later of (i) the Effective Date and (ii) SpyreApogee’s receipt of a written invoice that details the Pre-Effective Date Development Costs and includes reasonable documentation therefor. (b) Within [***] days after the end of each Calendar Year, Paragon will calculate and provide to Spyre Apogee a written reconciliation of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Year (“Actual Annual Costs”) against that portion of the Cost Advance for such Third Party Costs for that Calendar Year, including reasonable documentation of such Actual Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs in the Cost Advance exceeds the Actual Annual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the Budget and reasonably expected to be incurred by Paragon in the performance of the Research Program during any upcoming Calendar Year and Spyre Apogee will deduct such amount from its next quarterly Cost Cash Advance. If the Cost Advance is less than the Actual Annual Costs, then Paragon will invoice Spyre Apogee for the difference and Spyre Apogee will pay such amount together with its next quarterly Cost Advance. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Annual Development Fees.

Appears in 1 contract

Sources: Antibody Discovery and Option Agreement (Apogee Therapeutics, Inc.)

Development Costs. (ai) On a quarterly basis for each Research ProgramSubject to this Article 4.4, Spyre will advance to Paragon any all Development Costs contemplated incurred by the Parties in the BudgetDevelopment of the Product, including [***], and any [***] reasonably expected to be Development Costs incurred by Paragon in the performance of the Research Program during the upcoming [***] (less any pre-payments for Third Party Costs from earlier [***] that Paragon reasonably anticipates will be carried over to such upcoming [***]) (the “Cost Advance”). Spyre will pay the Cost Advance within [***] days after receipt of Paragon’s invoice for such Development Costs. The Parties acknowledge that Paragon has incurred approximately $10,000,000 in Development Costs Organon prior to the Effective Date, as a result of work performed by Paragon at risk on one or more Research Programs (the “Pre-Effective Date Development Costs”), which amount includes for Research Initiation Fees of $3,000,000 for a total of four Research Programs. Spyre shall reimburse Paragon for the Pre-Effective Date Development Costs no later than [***] days after the later of (i) the Effective Date and (ii) Spyre’s receipt of a written invoice that details the Pre-Effective Date Development Costs and includes reasonable documentation therefor. (b) Within [***] after the end of each Calendar Year, Paragon will calculate and provide to Spyre a written reconciliation of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Year (“Actual Annual Costs”) against that portion of the Cost Advance for such Third Party Costs for that Calendar Year, including reasonable documentation of such Actual Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs in the Cost Advance exceeds the Actual Annual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the Budget and reasonably expected to be incurred by Paragon in the performance of the Research Program during any upcoming Calendar Year and Spyre will deduct such amount from its next quarterly Cost Advance. If the Cost Advance is less than the Actual Annual Costs, then Paragon will invoice Spyre for the difference and Spyre will pay such amount together with its next quarterly Cost Advance. If no further amounts will be owed to Paragon hereunder, shared [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] percent ([CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]%) by Pfizer and [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] percent ([CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]%) by ▇▇▇▇▇▇▇ will refund such amount▇, provided, however, that Pfizer's share of Development Costs incurred by Organon prior to the Effective Date (the "Prior Development Costs") shall not exceed $[CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] USD in total. For clarityPromptly after execution of this Agreement, Organon shall provide Pfizer with supporting information setting forth, in detail, the then- current Prior Development Costs incurred by Organon and a forecast of additional Prior Development Costs that Organon expects to incur prior to the Effective Date. Within five (5) Business Days after the Effective Date, Organon shall provide Pfizer with a final accounting of the Prior Development Costs, and Pfizer shall have fifteen (15) Business Days to review such accounting. Within twenty (20) Business Days of receipt of such accounting, Pfizer shall pay, in accordance with Article 9.5, its [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] percent ([CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]%) share of all such Prior Development Costs that are not in good faith disputed by ▇▇▇▇▇▇. (ii) If Pfizer declines to exercise its rights to terminate this Agreement either under (x) Article 13.5(i)(c) based on the results of the [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]; or (y) Article 13.5(ii)(a) based on the results of the [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION], then, commencing with the date on which all of Pfizer's termination rights under those Articles have expired (the "Adjustment Date"), Development Costs for the Current Product for the Initial Indications will be shared [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] percent ([CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]%) by ▇▇▇▇▇▇ and [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] percent ([CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]%) by ▇▇▇▇▇▇▇, and such adjustment will also apply retroactively, subject to the limitation described in Article 4.4(i), for all Development Costs for the Current Product for the Initial Indications incurred by the Parties prior to the Adjustment Date. (iii) If Pfizer has declined to exercise its right to terminate this Agreement under (x) Article 13.5(i)(c); and (y) Article13.5(ii)(a), then, within ten (10) Business Days of the Adjustment Date, Pfizer will send a written notice to that effect to Organon which notice shall identify any amounts due as a result of the retroactive application of the adjustment to the Parties' sharing of Development Costs set forth in subparagraph (ii) above reconciliation (the "Adjustment Amount"). Within ten (10) Business Days of the date of such notice, Pfizer will not apply pay Organon the Adjustment Amount in accordance with the provisions of Article 9.5. (iv) The Parties have determined that the total Development Costs required to Annual obtain a Regulatory Approval for a Product meeting the Product Profile in the Major Market Countries is [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] (US$[CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]) (the "Estimated Development FeesCosts"). The Parties agree that either Party may exceed the Estimated Development Costs by up to [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] percent ([CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]%) if such excess expenditure is necessary to comply with such Party's obligations under the then-current Development Plan, provided, however, that unless mutually agreed-upon by the Parties, neither Party shall be required to reimburse the other for any Development Costs incurred by the other Party in excess of [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] percent ([CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]%) of such Party's share of the Estimated Development Costs.

Appears in 1 contract

Sources: License and Collaboration Agreement

Development Costs. (a) On a quarterly basis for each Research Program, Spyre will advance to Paragon any Development Costs contemplated in the Budget, including [***]] of the applicable Annual Development Fee, and any [***] reasonably expected to be incurred by Paragon in the performance of the Research Program during the upcoming [***] (less any pre-payments for Third Party Costs from earlier [***] that Paragon reasonably anticipates will be carried over to such upcoming [***]) (the “Cost Advance”). Spyre will pay the Cost Advance within [***] days after receipt of Paragon’s invoice for such Development Costs. The Parties acknowledge that Paragon has incurred approximately ten million dollars ($10,000,000 10,000,000) in Development Costs prior to the Effective Date, as a result of work performed by Paragon at risk on one or more Research Programs (the “Pre-Effective Date Development Costs”), which amount includes for Research Initiation Fees of three million dollars ($3,000,000 3,000,000) for a total of four Research Programs. Spyre shall reimburse Paragon for the Pre-Effective Date Development Costs no later than [***] days after the later of (i) the Effective Date and (ii) Spyre’s receipt of a written invoice that details the Pre-Effective Date Development Costs and includes reasonable documentation therefor. (b) Within [***] days after the end of each Calendar Year, Paragon will calculate and provide to Spyre a written reconciliation of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Year (“Actual Annual Costs”) against that portion of the Cost Advance for such Third Party Costs for that Calendar Year, including reasonable documentation of such Actual Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs in the Cost Advance exceeds the Actual Annual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the Budget and reasonably expected to be incurred by Paragon in the performance of the Research Program during any upcoming Calendar Year and Spyre will deduct such amount from its next quarterly Cost Advance. If the Cost Advance is less than the Actual Annual Costs, then Paragon will invoice Spyre for the difference and Spyre will pay such amount together with its next quarterly Cost Advance. If no further amounts will be owed to Paragon hereunder, ▇▇▇Paragon ▇▇▇▇ will refund ▇▇fund such amount. For clarity, the above reconciliation will not apply to Annual Development Fees. (c) Notwithstanding Sections 5.2(a) and 5.2(b) to the contrary, the Parties have agreed that (i) Paragon shall only invoice Spyre for fifty percent (50%) of the Development Costs for the IL-23 Research Program incurred from and after April 1, 2024 through completion of the IL-23 Selection Process, and (ii) Spyre shall only be responsible for fifty percent (50%) of the Development Costs for the IL-23 Research Program incurred prior to April 1, 2024 provided that Paragon receives rights to at least one (1) Retained IL-23 Project Antibody following completion of the IL-23 Selection Process. Within [***] days following completion of the IL-23 Selection Process, Paragon shall (1) deliver to Spyre a statement setting forth (x) the total amount of the Development Costs for the IL-23 Research Program incurred prior to April 1, 2024, (y) the total amount of such Development Costs paid by Spyre, and (z) a reconciliation of the amounts to be reimbursed by Paragon to Spyre such that Spyre shall only be responsible for fifty (50%) of the total amount of the Development Costs for the IL-23 Research Program incurred prior to April 1, 2024, and (2) pay to Spyre the amounts to be reimbursed as set forth in such statement.

Appears in 1 contract

Sources: Antibody Discovery and Option Agreement (Spyre Therapeutics, Inc.)

Development Costs. (a) The monthly rate for the Development Fees (the “Monthly Rate”) shall be determined and charged on a Research Program-by-Research Program and calendar month-by-calendar month basis based on, with respect to any particular calendar month, the total number of Research Programs being conducted under this Agreement and each other similar Antibody Discovery and Option Agreement between Paragon and Paruka, on the one hand, and Oruka or any Affiliate of Oruka, on the other hand (each such Research Program, an “Active Research Program”). For the period beginning on the Effective Date and continuing through December 31, 2024, the Monthly Rate for each Active Research Program in a particular calendar month shall be [***]. Paragon shall have the right to adjust the Monthly Rate on an annual basis to account for inflation and other increases in costs by providing written notice thereof to Oruka at least [***] days prior to the commencement of each [***]. (b) On a quarterly basis for each Research Programbasis, Spyre ▇▇▇▇▇ will advance to Paragon any Development Costs contemplated in the Research Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of the Research Program during the upcoming [***] in accordance with the Research Plan and Research Budget (less any pre-payments for Third Party Costs from earlier [***] that Paragon reasonably anticipates will be carried over to such upcoming [***]) (the “Cost Advance”). Spyre On a quarterly basis, ▇▇▇▇▇▇▇ will deliver an invoice to Oruka for the Cost Advance, and Oruka will pay the Cost Advance within [***] days after receipt of Paragon’s invoice for such Development Costs. The Parties acknowledge that Paragon has incurred approximately $10,000,000 in Development Costs prior to the Effective Date, as a result of work performed by Paragon at risk on one or more Research Programs (the “Pre-Effective Date Development Costs”), which amount includes for Research Initiation Fees of $3,000,000 for a total of four Research Programs. Spyre shall reimburse Paragon for the Pre-Effective Date Development Costs no later than [***] days after the later of (i) the Effective Date and (ii) Spyre’s receipt of a written invoice that details the Pre-Effective Date Development Costs and includes reasonable documentation thereforinvoice. (bc) Within [***] after the end of each Calendar Year, Paragon will calculate and provide to Spyre Oruka a written reconciliation of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Year (“Actual Annual Costs”) against that portion of the Cost Advance for such Third Party Costs for that Calendar Year, including reasonable documentation of such Actual Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs in the Cost Advance exceeds the Actual Annual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the Budget and reasonably expected to be incurred by Paragon in the performance of the Research Program during any upcoming Calendar Year and Spyre Oruka will deduct such amount from its next quarterly Cost Advance. If the Cost Advance is less than the Actual Annual Costs, then Paragon will invoice Spyre Oruka for the difference and Spyre Oruka will pay such amount together with its next quarterly Cost Advance. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Annual Development Fees. (d) Notwithstanding Sections ‎5.2(a), ‎5.2(b) and ‎5.2(c) to the contrary, the Parties acknowledge that Paragon has incurred (i) [***] in Development Costs through December 31, 2023, and (ii) certain additional Development Costs between January 1, 2024 and the Effective Date, as a result of work performed by Paragon at risk on the Research Program for IL-17A/F (the costs described in (i) and (ii), the “IL-17A/F Pre-Effective Date Development Costs”). Oruka shall reimburse Paragon for the IL-17A/F Pre-Effective Date Development Costs within [***] after ▇▇▇▇▇’s receipt of a written invoice that details the IL-17A/F Pre-Effective Date Development Costs.

Appears in 1 contract

Sources: Antibody Discovery and Option Agreement (ARCA Biopharma, Inc.)

Development Costs. (ai) On a quarterly basis for each Research ProgramSubject to this Article 4.4, Spyre will advance to Paragon any all Development Costs contemplated incurred by the Parties in the BudgetDevelopment of the Product, including [***], and any [***] reasonably expected to be Development Costs incurred by Paragon in the performance of the Research Program during the upcoming [***] (less any pre-payments for Third Party Costs from earlier [***] that Paragon reasonably anticipates will be carried over to such upcoming [***]) (the “Cost Advance”). Spyre will pay the Cost Advance within [***] days after receipt of Paragon’s invoice for such Development Costs. The Parties acknowledge that Paragon has incurred approximately $10,000,000 in Development Costs Organon prior to the Effective Date, will be shared [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] percent ([CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]%) by Pfizer and [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] percent ([CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]%) by Organon, provided, however, that Pfizer's share of Development Costs incurred by Organon prior to the Effective Date (the "Prior Development Costs") shall not exceed $[CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] USD in total. Promptly after execution of this Agreement, Organon shall provide Pfizer with supporting information setting forth, in detail, the then- current Prior Development Costs incurred by Organon and a forecast of additional Prior Development Costs that Organon expects to incur prior to the Effective Date. Within five (5) Business Days after the Effective Date, Organon shall provide Pfizer with a final accounting of the Prior Development Costs, and Pfizer shall have fifteen (15) Business Days to review such accounting. Within twenty (20) Business Days of receipt of such accounting, Pfizer shall pay, in accordance with Article 9.5, its [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] percent ([CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]%) share of all such Prior Development Costs that are not in good faith disputed by Pfizer. (ii) If Pfizer declines to exercise its rights to terminate this Agreement either under (x) Article 13.5(i)(c) based on the results of the [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]; or (y) Article 13.5(ii)(a) based on the results of the [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION], then, commencing with the date on which all of Pfizer's termination rights under those Articles have expired (the "Adjustment Date"), Development Costs for the Current Product for the Initial Indications will be shared [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] percent ([CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]%) by Pfizer and [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] percent ([CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]%) by Organon, and such adjustment will also apply retroactively, subject to the limitation described in Article 4.4(i), for all Development Costs for the Current Product for the Initial Indications incurred by the Parties prior to the Adjustment Date. (iii) If Pfizer has declined to exercise its right to terminate this Agreement under (x) Article 13.5(i)(c); and (y) Article13.5(ii)(a), then, within ten (10) Business Days of the Adjustment Date, Pfizer will send a written notice to that effect to Organon which notice shall identify any amounts due as a result of work performed by Paragon at risk on one or more Research Programs (the “Pre-Effective Date Development Costs”), which amount includes for Research Initiation Fees retroactive application of $3,000,000 for a total the adjustment to the Parties' sharing of four Research Programs. Spyre shall reimburse Paragon for the Pre-Effective Date Development Costs no later than [***] days after the later of (i) the Effective Date and set forth in subparagraph (ii) Spyre’s receipt above (the "Adjustment Amount"). Within ten (10) Business Days of a written invoice that details the Pre-Effective Date Development Costs and includes reasonable documentation therefordate of such notice, Pfizer will pay Organon the Adjustment Amount in accordance with the provisions of Article 9.5. (biv) Within The Parties have determined that the total Development Costs required to obtain a Regulatory Approval for a Product meeting the Product Profile in the Major Market Countries is [***CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] after (US$[CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]) (the end "Estimated Development Costs"). The Parties agree that either Party may exceed the Estimated Development Costs by up to [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] percent ([CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]%) if such excess expenditure is necessary to comply with such Party's obligations under the then-current Development Plan, provided, however, that unless mutually agreed-upon by the Parties, neither Party shall be required to reimburse the other for any Development Costs incurred by the other Party in excess of each Calendar Year, Paragon will calculate and provide to Spyre a written reconciliation [CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION] percent ([CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION]%) of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Year (“Actual Annual Costs”) against that portion such Party's share of the Cost Advance for such Third Party Costs for that Calendar Year, including reasonable documentation of such Actual Annual Estimated Development Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs in the Cost Advance exceeds the Actual Annual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the Budget and reasonably expected to be incurred by Paragon in the performance of the Research Program during any upcoming Calendar Year and Spyre will deduct such amount from its next quarterly Cost Advance. If the Cost Advance is less than the Actual Annual Costs, then Paragon will invoice Spyre for the difference and Spyre will pay such amount together with its next quarterly Cost Advance. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Annual Development Fees.

Appears in 1 contract

Sources: License and Collaboration Agreement (Akzo Nobel Nv)

Development Costs. (a) On a quarterly basis for each Research Program, Spyre will advance to Paragon any Development Costs contemplated in the Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of the Research Program during the upcoming [***] (less any pre-payments for Third Party Costs from earlier [***] that Paragon reasonably anticipates will be carried over to such upcoming [***]) (the “Cost Advance”). Spyre will pay the Cost Advance within [***] days after receipt of Paragon’s invoice for such Development Costs. The Parties acknowledge that Paragon has incurred approximately $10,000,000 in Development Costs prior to the Effective Date, as a result of work performed by Paragon at risk on one or more Research Programs (Aradigm shall submit to Grifols an invoice for the “Pre-Development Costs that Aradigm reasonably expects to incur during the first calendar quarter after the Effective Date in accordance with the Development Costs”)Plan and the Budget. Thereafter, which amount includes for Research Initiation Fees of $3,000,000 for a total of four Research Programs. Spyre shall reimburse Paragon for the Pre-Effective Date Development Costs no later than [***] thirty (30) days prior to the start of each calendar quarter while Development of an Aradigm Product for the Initial Indication is ongoing, Aradigm shall submit to Grifols an invoice for the Development Costs that Aradigm reasonably expects to incur during such calendar quarter in accordance with the Development Plan and the Budget. Grifols shall pay each such invoice in Dollars, the initial invoice being payable no later than thirty (30) days following Grifols’ receipt of the invoice, and for each subsequent invoice that is properly invoiced no later than the first day of each such quarter, provided that the invoice is consistent with the Development Plan and Budget. Aradigm shall have no obligation to perform Development activities affected by Grifols’ withholding payment of Development Costs which were included in the Budget. Notwithstanding anything to the contrary in this Agreement, and without limiting Grifols rights at law or in equity, if Aradigm fails to perform any specific Development activity during a calendar quarter, Grifols shall have no obligation to pay Development Costs to Aradigm for future calendar quarters until, at the discretion of Grifols, (i) all amounts previously paid by Grifols for such Development activity not performed by Aradigm have been reimbursed by Aradigm or credited to Grifols, or (ii) such Development activity has been properly performed by Aradigm. Within sixty (60) days after the later end of (i) each calendar quarter while Development of an Aradigm Product for the Effective Date Initial Indication is ongoing and (ii) Spyre’s receipt for one calendar quarter thereafter, Aradigm shall provide to Grifols an accounting of a written invoice that details the Pre-Effective Date Development Costs and includes reasonable documentation thereforactually incurred by Aradigm during such calendar quarter, such accounting to be detailed in accordance with the categories set forth in the Development Plan. (b) Within [***] In the event that the actual Development Costs were less than the Development Costs invoiced by Aradigm for that calendar quarter, Aradigm shall include a credit on the next quarterly invoice for such over-payment by Grifols (or, if the Development of an Aradigm Product for the Initial Indication has been completed, refund such over-payment to Grifols within thirty (30) days). In the event that the actual Development Costs exceed the Development Costs invoiced by Aradigm for that calendar quarter, Aradigm shall include such excess Development Costs on the next quarterly invoice. Notwithstanding anything to the contrary, the total amount of Development Costs that Grifols shall be required to pay for each calendar quarter shall not exceed one hundred and thirty percent (130%) of the Budget for such calendar quarter, without Grifols’ prior written consent. Without limiting the foregoing, Aradigm shall promptly notify Grifols and the JSC in the event that Development Costs are expected to exceed the Budget in any calendar quarter during the Term. Aradigm shall have the right to include any Development Costs in excess of such one hundred and thirty percent (130%), to the extent not previously reimbursed by Grifols, in the Development Costs invoiced during the next calendar quarter (subject, in all events, to the 130% limitation per quarter). Subject to Grifols’ rights in Section 4.3(a), within sixty (60) days after the end of each Calendar Yearcalendar year, Paragon will calculate if Aradigm has incurred Development Costs in excess of one hundred and provide thirty percent (130%) in any calendar quarter in such calendar year and such excess Development Costs have not been paid by Grifols, then, provided Aradigm provides Grifols with documentation reasonably acceptable to Spyre a written reconciliation of its actually-incurred Third Party Grifols verifying such Development Costs, Grifols shall pay such unpaid, excess Development Costs to Aradigm within thirty (incurred 30) days after Aradigm provides Grifols with such documentation. Notwithstanding anything to the contrary in a manner consistent this Agreement, in no event shall the total, aggregate Development Costs for which Grifols is liable under this Agreement with respect to the Budget) Aradigm Product for the prior Calendar Year Initial Indication exceed sixty-five million dollars (“Actual Annual Costs”) against that portion of the Cost Advance for such Third Party Costs for that Calendar Year, including reasonable documentation of such Actual Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs in the Cost Advance exceeds the Actual Annual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the Budget and reasonably expected to be incurred by Paragon in the performance of the Research Program during any upcoming Calendar Year and Spyre will deduct such amount from its next quarterly Cost Advance. If the Cost Advance is less than the Actual Annual Costs, then Paragon will invoice Spyre for the difference and Spyre will pay such amount together with its next quarterly Cost Advance. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Annual Development Fees$65,000,000).

Appears in 1 contract

Sources: License and Collaboration Agreement (Aradigm Corp)

Development Costs. (a) The monthly rate for the Development Fees (the “Monthly Rate”) shall be determined and charged on a Research Program-by-Research Program and calendar month-by-calendar month basis based on, with respect to any particular calendar month, the total number of Research Programs being conducted under this Agreement and each other similar Antibody Discovery and Option Agreement between Paragon and Paruka, on the one hand, and Oruka or any Affiliate of Oruka, on the other hand (each such Research Program, an “Active Research Program”). For the period beginning on March 31, 2024 and continuing through December 31, 2024, the Monthly Rate for each Active Research Program in a particular calendar month shall be [***]. Paragon shall have the right to adjust the Monthly Rate on an annual basis to account for inflation and other increases in costs by providing written notice thereof to Oruka at least [***] days prior to the commencement of each [***]. (b) On a quarterly basis for each Research Programbasis, Spyre ▇▇▇▇▇ will advance to Paragon any Development Costs contemplated in the Research Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of the Research Program during the upcoming [***] in accordance with the Research Plan and Research Budget (less any pre-payments for Third Party Costs from earlier [***] that Paragon reasonably anticipates will be carried over to such upcoming [***]) (the “Cost Advance”). Spyre On a quarterly basis, Paragon will deliver an invoice to Oruka for the Cost Advance, and Oruka will pay the Cost Advance within [***] days after receipt of Paragon’s invoice for such Development Costs. The Parties acknowledge that Paragon has incurred approximately $10,000,000 in Development Costs prior to the Effective Date, as a result of work performed by Paragon at risk on one or more Research Programs (the “Pre-Effective Date Development Costs”), which amount includes for Research Initiation Fees of $3,000,000 for a total of four Research Programs. Spyre shall reimburse Paragon for the Pre-Effective Date Development Costs no later than [***] days after the later of (i) the Effective Date and (ii) Spyre’s receipt of a written invoice that details the Pre-Effective Date Development Costs and includes reasonable documentation thereforinvoice. (bc) Within [***] days after the end of each Calendar Year, Paragon will calculate and provide to Spyre Oruka a written reconciliation of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Year (“Actual Annual Costs”) against that portion of the Cost Advance for such Third Party Costs for that Calendar Year, including reasonable documentation of such Actual Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs in the Cost Advance exceeds the Actual Annual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the Budget and reasonably expected to be incurred by Paragon in the performance of the Research Program during any upcoming Calendar Year and Spyre Oruka will deduct such amount from its next quarterly Cost Advance. If the Cost Advance is less than the Actual Annual Costs, then Paragon will invoice Spyre Oruka for the difference and Spyre Oruka will pay such amount together with its next quarterly Cost Advance. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Annual Development Fees. (d) Notwithstanding Sections 5.2(a), 5.2(b) and 5.2(c) to the contrary, the Parties have agreed that (i) [***] invoice [***] of the Development Costs for the IL-23 Research Program incurred from and after the March 31, 2024 through completion of the IL-23 Selection Process, and (ii) [***] of the Development Costs for the IL-23 Research Program incurred prior to March 31, 2024 (the “IL-23 Prior Development Costs”), provided that ▇▇▇▇▇ receives rights to at least one (1) Selected IL-23 Project Antibody following completion of the IL-23 Selection Process. Within [***] following completion of the IL-23 Selection Process, Paragon shall deliver to Oruka an invoice setting forth the IL-23 Prior Development Costs, and Oruka shall pay such invoice within [***] following receipt thereof.

Appears in 1 contract

Sources: Antibody Discovery and Option Agreement (ARCA Biopharma, Inc.)