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. For the period beginning on the Effective Date and continuing through December 31, 2025, the Monthly Rate for each Research Program in a particular calendar month shall be [***]. Paragon shall have the right to adjust the Monthly Rate on a bi-annual basis to account for inflation and other increases in costs by providing written notice thereof to Damora at least [***] prior to the end of the [***]. (b) On a quarterly and Research Program-by-Research Program basis, unless Damora has already paid a Cost Advance for the prior Calendar Quarter in accordance with Section 5.2(c), Paragon will deliver an invoice to Damora for the Development Costs incurred by Paragon in the performance of each Research Program during such Calendar Quarter, including [***] and any [***] incurred during such Calendar Quarter in a manner consistent with the applicable Budget and Damora will pay such amount within [***] after receipt of Paragon’s invoice. (c) At Paragon’s request, on a quarterly and Research Program-by-Research Program basis, Damora will advance to Paragon any Development Costs contemplated in the applicable Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of such Research Program during the upcoming Calendar Quarter in accordance with the applicable Research Plan and Budget (less any pre-payments for Third Party Costs from earlier Calendar Quarters that Paragon reasonably anticipates will be carried over to such upcoming Calendar Quarter) (the “Cost Advance”). Paragon’s request for the Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice to Damora prior to the start of such Calendar Quarter, and Damora will pay the Cost Advance within [***] after receipt of Paragon’s invoice. (d) Within [***] after the end of each Calendar Quarter in which any Third Party Costs have been paid, Paragon will calculate and provide to Damora a written reconciliation on a Research Program-by-Research Program basis, of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Quarter for which any Third Party Costs have been paid (“Actual Quarterly Costs”) against the Third Party Costs paid for that Calendar Quarter, including reasonable documentation of such Actual Quarterly Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for Third Party Costs for a Research Program exceed the Actual Quarterly Costs for such Research Program, then Paragon will credit such excess payment against Development Costs contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such Research Program during any upcoming Calendar Quarter and Damora will deduct such amount from its next quarterly invoice. If the amounts paid for Third Party Costs for a Research Program are less than the Actual Quarterly Costs for such Research Program, then Paragon will invoice Damora for the difference and Damora will pay such amount together with its next quarterly invoice for such Research Program. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Development Fees for a Research Program. (e) Notwithstanding Sections 5.2(a), 5.2(b), 5.2(c) and 5.2(d) to the contrary, the Parties acknowledge that Paragon has incurred (i) approximately Ten Million Six Hundred Thousand Dollars ($10,600,000) in Development Costs through September 30, 2025, and (ii) certain additional Development Costs between October 1, 2025 and the Effective Date, as a result of work performed by Paragon at risk on the Research Programs listed on Exhibit A (the costs described in (i) and (ii), the “Pre-Effective Date Development Costs”). Damora shall reimburse Paragon for the Pre-Effective Date Development Costs within [***] after ▇▇▇▇▇▇’▇ receipt of a written invoice that details the Pre-Effective Date Development Costs. (f) If a Research Program requires Paragon to perform CMC Activities in furtherance of the applicable Research Program, then Damora shall pay Paragon the CMC Monthly Fee until the full amount of the CMC Fee has been paid. On a quarterly and Research Program-by-Research Program basis, Paragon will deliver an invoice to Damora for the CMC Monthly Fees accrued for the prior Calendar Quarter and Damora will pay such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee is separate from any Development Costs or Cost Advance paid or owing with respect to a Research Program. (g) All payments made by Damora under this Section 5.2 shall be non-refundable and non-creditable except as otherwise provide in Section 5.2(d) with respect to reconciling excess amounts paid for Third Party Costs which cannot otherwise be credited.
Appears in 2 contracts
Sources: Antibody Discovery and Option Agreement (Galecto, Inc.), Antibody Discovery and Option Agreement (Galecto, 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. For the period beginning on the Effective Date and continuing through December 31, 2025, the Monthly Rate for each Research Program in a particular calendar month shall be [***]. Paragon shall have the right to adjust the Monthly Rate on a bi-annual basis to account for inflation and other increases in costs by providing written notice thereof to Damora at least [***] prior to the end of the [***].
(b) On a quarterly and basis for each Research Program-by-Research Program basis, unless Damora has already paid a Cost Advance for the prior Calendar Quarter in accordance with Section 5.2(c), Paragon will deliver an invoice to Damora for the Development Costs incurred by Paragon in the performance of each Research Program during such Calendar Quarter, including [***] and any [***] incurred during such Calendar Quarter in a manner consistent with the applicable Budget and Damora will pay such amount within [***] after receipt of Paragon’s invoice.
(c) At Paragon’s request, on a quarterly and Research Program-by-Research Program basis, Damora Spyre will advance to Paragon any Development Costs contemplated in the applicable Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of such the Research Program during the upcoming Calendar Quarter in accordance with the applicable Research Plan and Budget [***] (less any pre-payments for Third Party Costs from earlier Calendar Quarters [***] that Paragon reasonably anticipates will be carried over to such upcoming Calendar Quarter[***]) (the “Cost Advance”). Paragon’s request for the Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice to Damora prior to the start of such Calendar Quarter, and Damora Spyre will pay the Cost Advance within [***] days after receipt of Paragon’s invoiceinvoice 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.
(db) Within [***] after the end of each Calendar Quarter in which any Third Party Costs have been paidYear, Paragon will calculate and provide to Damora Spyre a written reconciliation on a Research Program-by-Research Program basis, of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Quarter for which any Third Party Costs have been paid Year (“Actual Quarterly Annual Costs”) against that portion of the Cost Advance for such Third Party Costs paid for that Calendar QuarterYear, including reasonable documentation of such Actual Quarterly Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs for a Research Program exceed in the Cost Advance exceeds the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such the Research Program during any upcoming Calendar Quarter Year and Damora Spyre will deduct such amount from its next quarterly invoiceCost Advance. If the amounts paid for Third Party Costs for a Research Program are Cost Advance is less than the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will invoice Damora Spyre for the difference and Damora Spyre will pay such amount together with its next quarterly invoice for such Research ProgramCost 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 for a Research ProgramFees.
(e) Notwithstanding Sections 5.2(a), 5.2(b), 5.2(c) and 5.2(d) to the contrary, the Parties acknowledge that Paragon has incurred (i) approximately Ten Million Six Hundred Thousand Dollars ($10,600,000) in Development Costs through September 30, 2025, and (ii) certain additional Development Costs between October 1, 2025 and the Effective Date, as a result of work performed by Paragon at risk on the Research Programs listed on Exhibit A (the costs described in (i) and (ii), the “Pre-Effective Date Development Costs”). Damora shall reimburse Paragon for the Pre-Effective Date Development Costs within [***] after ▇▇▇▇▇▇’▇ receipt of a written invoice that details the Pre-Effective Date Development Costs.
(f) If a Research Program requires Paragon to perform CMC Activities in furtherance of the applicable Research Program, then Damora shall pay Paragon the CMC Monthly Fee until the full amount of the CMC Fee has been paid. On a quarterly and Research Program-by-Research Program basis, Paragon will deliver an invoice to Damora for the CMC Monthly Fees accrued for the prior Calendar Quarter and Damora will pay such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee is separate from any Development Costs or Cost Advance paid or owing with respect to a Research Program.
(g) All payments made by Damora under this Section 5.2 shall be non-refundable and non-creditable except as otherwise provide in Section 5.2(d) with respect to reconciling excess amounts paid for Third Party Costs which cannot otherwise be credited.
Appears in 2 contracts
Sources: Antibody Discovery and Option Agreement (Spyre Therapeutics, Inc.), Antibody Discovery and Option Agreement (Aeglea BioTherapeutics, 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. For the period beginning on the Effective Date and continuing through December 31, 2025, the Monthly Rate for each Research Program in a particular calendar month shall be [***]. Paragon shall have the right to adjust the Monthly Rate on a bi-annual basis to account for inflation and other increases in costs by providing written notice thereof to Damora at least [***] prior to the end of the [***].
(b) On a quarterly and basis for each Research Program-by-Research Program basis, unless Damora has already paid a Cost Advance for the prior Calendar Quarter in accordance with Section 5.2(c), Paragon will deliver an invoice to Damora for the Development Costs incurred by Paragon in the performance of each Research Program during such Calendar Quarter, including [***] and any [***] incurred during such Calendar Quarter in a manner consistent with the applicable Budget and Damora will pay such amount within [***] after receipt of Paragon’s invoice.
(c) At Paragon’s request, on a quarterly and Research Program-by-Research Program basis, Damora Apogee will advance to Paragon any Development Costs contemplated in the applicable Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of such the Research Program during the upcoming Calendar Quarter in accordance with the applicable Research Plan and Budget [***] (less any pre-payments for Third Party Costs [***] from earlier Calendar Quarters [***] that Paragon reasonably anticipates will be carried over to such upcoming Calendar Quarter[***] ) (the “Cost Advance”). Paragon’s request for the Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice to Damora prior to the start of such Calendar Quarter, and Damora Apogee will pay the Cost Advance within [***] days after receipt of Paragon’s invoiceinvoice for such Development Costs. The Parties acknowledge that Paragon has incurred approximately $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”). 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) Apogee’s receipt of a written invoice that details the Pre-Effective Date Development Costs and includes reasonable documentation therefor.
(db) Within [***] days after the end of each Calendar Quarter in which any Third Party Costs have been paidYear, Paragon will calculate and provide to Damora Apogee a written reconciliation on a Research Program-by-Research Program basis, of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Quarter for which any Third Party Costs have been paid Year (“Actual Quarterly Annual Costs”) against that portion of the Cost Advance for such Third Party Costs paid for that Calendar QuarterYear, including reasonable documentation of such Actual Quarterly Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs for a Research Program exceed in the Cost Advance exceeds the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such the Research Program during any upcoming Calendar Quarter Year and Damora Apogee will deduct such amount from its next quarterly invoiceCash Advance. If the amounts paid for Third Party Costs for a Research Program are Cost Advance is less than the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will invoice Damora Apogee for the difference and Damora Apogee will pay such amount together with its next quarterly invoice for such Research ProgramCost 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 for a Research ProgramFees.
(e) Notwithstanding Sections 5.2(a), 5.2(b), 5.2(c) and 5.2(d) to the contrary, the Parties acknowledge that Paragon has incurred (i) approximately Ten Million Six Hundred Thousand Dollars ($10,600,000) in Development Costs through September 30, 2025, and (ii) certain additional Development Costs between October 1, 2025 and the Effective Date, as a result of work performed by Paragon at risk on the Research Programs listed on Exhibit A (the costs described in (i) and (ii), the “Pre-Effective Date Development Costs”). Damora shall reimburse Paragon for the Pre-Effective Date Development Costs within [***] after ▇▇▇▇▇▇’▇ receipt of a written invoice that details the Pre-Effective Date Development Costs.
(f) If a Research Program requires Paragon to perform CMC Activities in furtherance of the applicable Research Program, then Damora shall pay Paragon the CMC Monthly Fee until the full amount of the CMC Fee has been paid. On a quarterly and Research Program-by-Research Program basis, Paragon will deliver an invoice to Damora for the CMC Monthly Fees accrued for the prior Calendar Quarter and Damora will pay such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee is separate from any Development Costs or Cost Advance paid or owing with respect to a Research Program.
(g) All payments made by Damora under this Section 5.2 shall be non-refundable and non-creditable except as otherwise provide in Section 5.2(d) with respect to reconciling excess amounts paid for Third Party Costs which cannot otherwise be credited.
Appears in 1 contract
Sources: Antibody Discovery and Option Agreement (Apogee 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. For the period beginning on the Effective Date and continuing through December 31, 2025, the Monthly Rate for each Research Program in a particular calendar month shall be [***]. Paragon shall have the right to adjust the Monthly Rate on a bi-annual basis to account for inflation and other increases in costs by providing written notice thereof to Damora at least [***] prior to the end of the [***].
(b) On a quarterly and basis for each Research Program-by-Research Program basis, unless Damora has already paid a Cost Advance for the prior Calendar Quarter in accordance with Section 5.2(c), Paragon will deliver an invoice to Damora for the Development Costs incurred by Paragon in the performance of each Research Program during such Calendar Quarter, including [***] and any [***] incurred during such Calendar Quarter in a manner consistent with the applicable Budget and Damora will pay such amount within [***] after receipt of Paragon’s invoice.
(c) At Paragon’s request, on a quarterly and Research Program-by-Research Program basis, Damora Spyre will advance to Paragon any Development Costs contemplated in the applicable Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of such the Research Program during the upcoming Calendar Quarter in accordance with the applicable Research Plan and Budget [***] (less any pre-payments for Third Party Costs [***] from earlier Calendar Quarters [***] that Paragon reasonably anticipates will be carried over to such upcoming Calendar Quarter[***] ) (the “Cost Advance”). Paragon’s request for the Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice to Damora prior to the start of such Calendar Quarter, and Damora Spyre will pay the Cost Advance within [***] days after receipt of Paragon’s invoiceinvoice 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.
(db) Within [***] days after the end of each Calendar Quarter in which any Third Party Costs have been paidYear, Paragon will calculate and provide to Damora Spyre a written reconciliation on a Research Program-by-Research Program basis, of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Quarter for which any Third Party Costs have been paid Year (“Actual Quarterly Annual Costs”) against that portion of the Cost Advance for such Third Party Costs paid for that Calendar QuarterYear, including reasonable documentation of such Actual Quarterly Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs for a Research Program exceed in the Cost Advance exceeds the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such the Research Program during any upcoming Calendar Quarter Year and Damora Spyre will deduct such amount from its next quarterly invoiceCost Advance. If the amounts paid for Third Party Costs for a Research Program are Cost Advance is less than the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will invoice Damora Spyre for the difference and Damora Spyre will pay such amount together with its next quarterly invoice for such Research ProgramCost 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 for a Research ProgramFees.
(e) Notwithstanding Sections 5.2(a), 5.2(b), 5.2(c) and 5.2(d) to the contrary, the Parties acknowledge that Paragon has incurred (i) approximately Ten Million Six Hundred Thousand Dollars ($10,600,000) in Development Costs through September 30, 2025, and (ii) certain additional Development Costs between October 1, 2025 and the Effective Date, as a result of work performed by Paragon at risk on the Research Programs listed on Exhibit A (the costs described in (i) and (ii), the “Pre-Effective Date Development Costs”). Damora shall reimburse Paragon for the Pre-Effective Date Development Costs within [***] after ▇▇▇▇▇▇’▇ receipt of a written invoice that details the Pre-Effective Date Development Costs.
(f) If a Research Program requires Paragon to perform CMC Activities in furtherance of the applicable Research Program, then Damora shall pay Paragon the CMC Monthly Fee until the full amount of the CMC Fee has been paid. On a quarterly and Research Program-by-Research Program basis, Paragon will deliver an invoice to Damora for the CMC Monthly Fees accrued for the prior Calendar Quarter and Damora will pay such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee is separate from any Development Costs or Cost Advance paid or owing with respect to a Research Program.
(g) All payments made by Damora under this Section 5.2 shall be non-refundable and non-creditable except as otherwise provide in Section 5.2(d) with respect to reconciling excess amounts paid for Third Party Costs which cannot otherwise be credited.
Appears in 1 contract
Sources: Antibody Discovery and Option Agreement (Aeglea BioTherapeutics, 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. For the period beginning on the Effective Date and continuing through December 31, 20252024, the Monthly Rate for each shall be [***]. If the Research Program Plan requires Paragon to perform certain chemistry, manufacturing, and control activities (“CMC Activities”) in a particular calendar month 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 a bi-an annual basis to account for inflation and other increases in costs by providing written notice thereof to Damora Crescent at least [***] prior to the end commencement of the each [***].
(b) On a quarterly and Research Program-by-Research Program basis, unless Damora has already paid a Cost Advance for the prior Calendar Quarter in accordance with Section 5.2(c), Paragon will deliver an invoice to Damora for the Development Costs incurred by Paragon in the performance of each Research Program during such Calendar Quarter, including [***] and any [***] incurred during such Calendar Quarter in a manner consistent with the applicable Budget and Damora will pay such amount within [***] after receipt of Paragon’s invoice.
(c) At Paragon’s request, on a quarterly and Research Program-by-Research Program basis, Damora Crescent will advance to Paragon any Development Costs contemplated in the applicable Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of such the Research Program during the upcoming Calendar Quarter [***] in accordance with the applicable Research Plan and Budget (less any pre-payments for Third Party Costs from earlier Calendar Quarters [***] that Paragon reasonably anticipates will be carried over to such upcoming Calendar Quarter[***]) (the “Cost Advance”). Paragon’s request On a quarterly basis, Paragon will deliver an invoice to Crescent for the Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice to Damora prior to the start of such Calendar QuarterAdvance, and Damora Crescent will pay the Cost Advance within [***] after receipt of Paragon’s invoice.
(dc) Within [***] after the end of each Calendar Quarter in which any Third Party Costs have been paidYear, Paragon will calculate and provide to Damora Crescent a written reconciliation on a Research Program-by-Research Program basis, of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Quarter for which any Third Party Costs have been paid Year (“Actual Quarterly Annual Costs”) against that portion of the Cost Advance for such Third Party Costs paid for that Calendar QuarterYear, including reasonable documentation of such Actual Quarterly Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs for a Research Program exceed in the Cost Advance exceeds the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such the Research Program during any upcoming Calendar Quarter Year and Damora Crescent will deduct such amount from its next quarterly invoiceCost Advance. If the amounts paid for Third Party Costs for a Research Program are Cost Advance is less than the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will invoice Damora Crescent for the difference and Damora Crescent will pay such amount together with its next quarterly invoice for such Research ProgramCost 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 for a Research ProgramFees. [***] = 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.
(ed) Notwithstanding Sections 5.2(a), 5.2(b), 5.2(c) and 5.2(d5.2(c) to the contrary, the Parties acknowledge that Paragon has incurred (i) approximately Ten Million Six Hundred Thousand Dollars ($10,600,000) in Development Costs through September 30, 2025, and (ii) certain additional Development Costs between October 1, 2025 2024 and the Effective Date, as a result of work performed by Paragon at risk on the Research Programs listed on Exhibit A Program (the costs described in (i) and (ii), the “Pre-Effective Date Development Costs”). Damora 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.
(f) If a Research Program requires Paragon to perform CMC Activities in furtherance of the applicable Research Program, then Damora shall pay Paragon the CMC Monthly Fee until the full amount of the CMC Fee has been paid. On a quarterly and Research Program-by-Research Program basis, Paragon will deliver an invoice to Damora for the CMC Monthly Fees accrued for the prior Calendar Quarter and Damora will pay such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee is separate from any Development Costs or Cost Advance paid or owing with respect to a Research Program.
(g) All payments made by Damora under this Section 5.2 shall be non-refundable and non-creditable except as otherwise provide in Section 5.2(d) with respect to reconciling excess amounts paid for Third Party Costs which cannot otherwise be credited.
Appears in 1 contract
Sources: Adc Discovery and Option Agreement (Glycomimetics Inc)
Development Costs. (a) The monthly rate for If ALZA elects to pay the Development Fees (Fee upon exercise of the “Monthly Rate”) shall be determined and charged on a Research Program-by-Research Program and calendar month-by-calendar month basis. For the period beginning on the Effective Date and continuing through December 31, 2025, the Monthly Rate for each Research Program Option in a particular calendar month shall be [***]. Paragon shall have the right to adjust the Monthly Rate on a bi-annual basis to account for inflation and other increases in costs by providing written notice thereof to Damora at least [***] prior lump sum payment, Alkermes will fund all Development Costs up to the end amount of the [***].
(b) On a quarterly and Research Program-by-Research Program basisDevelopment Fee. In connection therewith, unless Damora has already paid a Cost Advance for the prior Calendar Quarter in accordance with Section 5.2(c), Paragon Alkermes will deliver an invoice to Damora for the Development Costs incurred by Paragon in the performance of each Research Program during such Calendar Quarter, including [***] and any [***] incurred during such Calendar Quarter in a manner consistent with the applicable Budget and Damora will pay such amount within [***] after receipt of Paragon’s invoice.
(c) At Paragon’s requestreimburse ALZA, on a quarterly and Research Program-by-Research Program monthly basis, Damora will advance to Paragon any all of ALZA's Development Costs contemplated in of the applicable BudgetProgram for Subterritory A, including [***], and any [***] reasonably expected 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 such Research Program during Definitive Agreement, equal the upcoming Calendar Quarter in accordance with the applicable Research Plan and Budget (less any pre-payments for Third Party Costs from earlier Calendar Quarters that Paragon reasonably anticipates will be carried over Development Fee. If ALZA elects to such upcoming Calendar Quarter) (the “Cost Advance”). Paragon’s request for the Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice to Damora prior to the start of such Calendar Quarter, and Damora will pay the Cost Advance within [***] after receipt of Paragon’s invoice.
(d) Within [***] after Anticipated Completion Costs on an ongoing basis, rather than paying the end of each Calendar Quarter in which any Third Party Costs have been paidDevelopment Fee, Paragon then ALZA will calculate and provide to Damora a written reconciliation reimburse Alkermes, on a Research Program-by-Research Program monthly basis, of its actually-for Alkermes' Development Costs duly incurred Third Party under the Definitive Agreement, until the total Development Costs (for Subterritory A incurred in a manner consistent with by both parties under the Budget) for Definitive Agreement equal the prior Calendar Quarter for which any Third Party Costs have been paid (“Actual Quarterly Anticipated Completion Costs”) against the Third Party Costs paid for that Calendar Quarter, including reasonable documentation of such Actual Quarterly Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for Third Party total Development Costs of the Program in Subterritory A incurred by the parties under the Definitive Agreement and as approved by the Collaboration Committee exceed the Development Fee or the Anticipated Completion Costs, as the case may be, the parties will bear any excess equally, on an ongoing basis, with appropriate monthly reimbursement. Development Costs for a Research Program exceed purposes of the Actual Quarterly Costs Definitive Agreement will mean those costs approved in advance by the Collaboration Committee for such Research Program, then Paragon will credit such excess payment against Development Costs contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such Research Program during any upcoming Calendar Quarter and Damora will deduct such amount from its next quarterly invoiceexpenditure. If the amounts paid for Third Party Costs for a Research Program are less than the Actual Quarterly Costs for such Research Program, then Paragon will invoice Damora for the difference and Damora will pay such amount together with its next quarterly invoice for such Research ProgramTHIS 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 Development Fees for a Research Program.
(e) Notwithstanding Sections 5.2(a), 5.2(b), 5.2(c) and 5.2(d) to the contrary, the Parties acknowledge that Paragon has incurred (i) approximately Ten Million Six Hundred Thousand Dollars ($10,600,000) in Development Costs through September 30, 2025, and (ii) certain additional Development Costs between October 1, 2025 and the Effective Date, as a result of work performed by Paragon at risk on the Research Programs listed on Exhibit REDACTED MATERIAL IS MARKED WITH A (the costs described in (i) and (ii), the “Pre-Effective Date Development Costs”). Damora shall reimburse Paragon for the Pre-Effective Date Development Costs within [***] after ▇▇▇▇▇▇’▇ receipt of a written invoice that details the Pre-Effective Date Development Costs* AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(f) If a Research Program requires Paragon to perform CMC Activities in furtherance of the applicable Research Program, then Damora shall pay Paragon the CMC Monthly Fee until the full amount of the CMC Fee has been paid. On a quarterly and Research Program-by-Research Program basis, Paragon will deliver an invoice to Damora for the CMC Monthly Fees accrued for the prior Calendar Quarter and Damora will pay such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee is separate from any Development Costs or Cost Advance paid or owing with respect to a Research Program.
(g) All payments made by Damora under this Section 5.2 shall be non-refundable and non-creditable except as otherwise provide in Section 5.2(d) with respect to reconciling excess amounts paid for Third Party Costs which cannot otherwise be credited.
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 basisbasis 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, 20252024, 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 a bi-an annual basis to account for inflation and other increases in costs by providing written notice thereof to Damora Jade at least [***] prior to the end commencement of the each [***]..
(b) On a quarterly and Research Program-by-Research Program basis, unless Damora has already paid a Cost Advance for the prior Calendar Quarter in accordance with Section 5.2(c), Paragon will deliver an invoice to Damora for the Development Costs incurred by Paragon in the performance of each Research Program during such Calendar Quarter, including [***] and any [***] incurred during such Calendar Quarter in a manner consistent with the applicable Budget and Damora will pay such amount within [***] after receipt of Paragon’s invoice.
(c) At Paragon’s request, on a quarterly and Research Program-by-Research Program basis, Damora ▇▇▇▇ will advance to Paragon any Development Costs contemplated in the applicable Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of such the Research Program during the upcoming Calendar Quarter [***] in accordance with the applicable Research Plan and Budget (less any pre-payments for Third Party Costs from earlier Calendar Quarters [***] that Paragon reasonably anticipates will be carried over to such upcoming Calendar Quarter[***]) (the “Cost Advance”). Paragon’s request On a quarterly basis, Paragon will deliver an invoice to Jade for the Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice to Damora prior to the start of such Calendar QuarterAdvance, and Damora ▇▇▇▇ will pay the Cost Advance within [***] after receipt of Paragon’s invoice.
(dc) Within [***] after the end of each Calendar Quarter in which any Third Party Costs have been paidYear, Paragon will calculate and provide to Damora ▇▇▇▇ a written reconciliation on a Research Program-by-Research Program basis, of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Quarter for which any Third Party Costs have been paid Year (“Actual Quarterly Annual Costs”) against that portion of the Cost Advance for such Third Party Costs paid for that Calendar QuarterYear, including reasonable documentation of such Actual Quarterly Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs for a Research Program exceed in the Cost Advance exceeds the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such the Research Program during any upcoming Calendar Quarter Year and Damora Jade will deduct such amount from its next quarterly invoiceCost Advance. If the amounts paid for Third Party Costs for a Research Program are Cost Advance is less than the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will invoice Damora Jade for the difference and Damora Jade will pay such amount together with its next quarterly invoice for such Research ProgramCost 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 for a Research ProgramFees.
(ed) Notwithstanding Sections 5.2(a), 5.2(b), 5.2(c) and 5.2(d5.2(c) to the contrary, the Parties acknowledge that Paragon has incurred (i) approximately Ten Million Six Hundred Thousand Dollars ($10,600,000) 5,611,515.00 in Development Costs through September June 30, 20252024, and (ii) certain additional Development Costs between October July 1, 2025 2024 and the Effective Date, as a result of work performed by Paragon at risk on the Research Programs listed on Exhibit A Program for APRIL (the costs described in (i) and (ii), the “Pre-Effective Date Development Costs”). Damora ▇▇▇▇ 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.
(f) If a Research Program requires Paragon to perform CMC Activities in furtherance of the applicable Research Program, then Damora shall pay Paragon the CMC Monthly Fee until the full amount of the CMC Fee has been paid. On a quarterly and Research Program-by-Research Program basis, Paragon will deliver an invoice to Damora for the CMC Monthly Fees accrued for the prior Calendar Quarter and Damora will pay such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee is separate from any Development Costs or Cost Advance paid or owing with respect to a Research Program.
(g) All payments made by Damora under this Section 5.2 shall be non-refundable and non-creditable except as otherwise provide in Section 5.2(d) with respect to reconciling excess amounts paid for Third Party Costs which cannot otherwise be credited.
Appears in 1 contract
Sources: Antibody Discovery and Option Agreement (Aerovate 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 basisbasis 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, 20252024, 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 a bi-an annual basis to account for inflation and other increases in costs by providing written notice thereof to Damora Oruka at least [***] days prior to the end commencement of the each [***].
(b) On a quarterly and Research Program-by-Research Program basis, unless Damora has already paid a Cost Advance for the prior Calendar Quarter in accordance with Section 5.2(c), Paragon will deliver an invoice to Damora for the Development Costs incurred by Paragon in the performance of each Research Program during such Calendar Quarter, including [***] and any [***] incurred during such Calendar Quarter in a manner consistent with the applicable Budget and Damora will pay such amount within [***] after receipt of Paragon’s invoice.
(c) At Paragon’s request, on a quarterly and Research Program-by-Research Program basis, Damora ▇▇▇▇▇ will advance to Paragon any Development Costs contemplated in the applicable Research Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of such the Research Program during the upcoming Calendar Quarter [***] in accordance with the applicable Research Plan and Research Budget (less any pre-payments for Third Party Costs from earlier Calendar Quarters [***] that Paragon reasonably anticipates will be carried over to such upcoming Calendar Quarter[***]) (the “Cost Advance”). Paragon’s request On a quarterly basis, ▇▇▇▇▇▇▇ will deliver an invoice to Oruka for the Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice to Damora prior to the start of such Calendar QuarterAdvance, and Damora Oruka will pay the Cost Advance within [***] after receipt of Paragon’s invoice.
(dc) Within [***] after the end of each Calendar Quarter in which any Third Party Costs have been paidYear, Paragon will calculate and provide to Damora Oruka a written reconciliation on a Research Program-by-Research Program basis, of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Quarter for which any Third Party Costs have been paid Year (“Actual Quarterly Annual Costs”) against that portion of the Cost Advance for such Third Party Costs paid for that Calendar QuarterYear, including reasonable documentation of such Actual Quarterly Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs for a Research Program exceed in the Cost Advance exceeds the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such the Research Program during any upcoming Calendar Quarter Year and Damora Oruka will deduct such amount from its next quarterly invoiceCost Advance. If the amounts paid for Third Party Costs for a Research Program are Cost Advance is less than the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will invoice Damora Oruka for the difference and Damora Oruka will pay such amount together with its next quarterly invoice for such Research ProgramCost 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 for a Research ProgramFees.
(ed) Notwithstanding Sections 5.2(a5.2(a), 5.2(b), 5.2(c5.2(b) and 5.2(d5.2(c) to the contrary, the Parties acknowledge that Paragon has incurred (i) approximately Ten Million Six Hundred Thousand Dollars ($10,600,000) [***] in Development Costs through September 30December 31, 20252023, and (ii) certain additional Development Costs between October January 1, 2025 2024 and the Effective Date, as a result of work performed by Paragon at risk on the Research Programs listed on Exhibit A Program for IL-17A/F (the costs described in (i) and (ii), the “IL-17A/F Pre-Effective Date Development Costs”). Damora 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.
(f) If a Research Program requires Paragon to perform CMC Activities in furtherance of the applicable Research Program, then Damora shall pay Paragon the CMC Monthly Fee until the full amount of the CMC Fee has been paid. On a quarterly and Research Program-by-Research Program basis, Paragon will deliver an invoice to Damora for the CMC Monthly Fees accrued for the prior Calendar Quarter and Damora will pay such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee is separate from any Development Costs or Cost Advance paid or owing with respect to a Research Program.
(g) All payments made by Damora under this Section 5.2 shall be non-refundable and non-creditable except as otherwise provide in Section 5.2(d) with respect to reconciling excess amounts paid for Third Party Costs which cannot otherwise be credited.
Appears in 1 contract
Sources: Antibody Discovery and Option Agreement (ARCA Biopharma, Inc.)
Development Costs. (ai) 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. For the period beginning on the Effective Date and continuing through December 31Subject to this Article 4.4, 2025, the Monthly Rate for each Research Program in a particular calendar month shall be [***]. Paragon shall have the right to adjust the Monthly Rate on a bi-annual basis to account for inflation and other increases in costs by providing written notice thereof to Damora at least [***] prior to the end of the [***].
(b) On a quarterly and Research Program-by-Research Program basis, unless Damora has already paid a Cost Advance for the prior Calendar Quarter in accordance with Section 5.2(c), Paragon will deliver an invoice to Damora for the all Development Costs incurred by Paragon the Parties in the performance Development of each Research Program during such Calendar Quarterthe Product, including Development Costs incurred by 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 any [***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 during 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 Calendar Quarter in a manner consistent with the applicable Budget and Damora will pay such amount within [***] after accounting. Within twenty (20) Business Days of receipt of Paragon’s invoicesuch 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.
(cii) At Paragon’s requestIf 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 a quarterly and Research Program-by-Research Program basiswhich all of Pfizer's termination rights under those Articles have expired (the "Adjustment Date"), Damora will advance to Paragon any Development Costs contemplated in for the applicable Budget, including 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 any [***] reasonably expected such adjustment will also apply retroactively, subject to be the limitation described in Article 4.4(i), for all Development Costs for the Current Product for the Initial Indications incurred by Paragon 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 (the performance "Adjustment Amount"). Within ten (10) Business Days of the date of such Research Program during notice, Pfizer will pay Organon the upcoming Calendar Quarter Adjustment Amount in accordance with the applicable Research Plan and Budget provisions of Article 9.5.
(less any pre-payments iv) The Parties have determined that the total Development Costs required to obtain a Regulatory Approval for Third Party Costs from earlier Calendar Quarters that Paragon reasonably anticipates will be carried over to such upcoming Calendar Quartera 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 “Cost Advance”"Estimated Development Costs"). Paragon’s request 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 Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice to Damora prior to the start 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 Calendar Quarter, and Damora will pay Party's share of the Cost Advance within [***] after receipt of Paragon’s invoice.
(d) Within [***] after the end of each Calendar Quarter in which any Third Party Costs have been paid, Paragon will calculate and provide to Damora a written reconciliation on a Research Program-by-Research Program basis, of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Quarter for which any Third Party Costs have been paid (“Actual Quarterly Costs”) against the Third Party Costs paid for that Calendar Quarter, including reasonable documentation of such Actual Quarterly Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for Third Party Costs for a Research Program exceed the Actual Quarterly Costs for such Research Program, then Paragon will credit such excess payment against Development Costs contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such Research Program during any upcoming Calendar Quarter and Damora will deduct such amount from its next quarterly invoice. If the amounts paid for Third Party Costs for a Research Program are less than the Actual Quarterly Costs for such Research Program, then Paragon will invoice Damora for the difference and Damora will pay such amount together with its next quarterly invoice for such Research Program. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Development Fees for a Research Program.
(e) Notwithstanding Sections 5.2(a), 5.2(b), 5.2(c) and 5.2(d) to the contrary, the Parties acknowledge that Paragon has incurred (i) approximately Ten Million Six Hundred Thousand Dollars ($10,600,000) in Development Costs through September 30, 2025, and (ii) certain additional Development Costs between October 1, 2025 and the Effective Date, as a result of work performed by Paragon at risk on the Research Programs listed on Exhibit A (the costs described in (i) and (ii), the “Pre-Effective Date Development Costs”). Damora shall reimburse Paragon for the Pre-Effective Date Development Costs within [***] after ▇▇▇▇▇▇’▇ receipt of a written invoice that details the Pre-Effective Date Estimated Development Costs.
(f) If a Research Program requires Paragon to perform CMC Activities in furtherance of the applicable Research Program, then Damora shall pay Paragon the CMC Monthly Fee until the full amount of the CMC Fee has been paid. On a quarterly and Research Program-by-Research Program basis, Paragon will deliver an invoice to Damora for the CMC Monthly Fees accrued for the prior Calendar Quarter and Damora will pay such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee is separate from any Development Costs or Cost Advance paid or owing with respect to a Research Program.
(g) All payments made by Damora under this Section 5.2 shall be non-refundable and non-creditable except as otherwise provide in Section 5.2(d) with respect to reconciling excess amounts paid for Third Party Costs which cannot otherwise be credited.
Appears in 1 contract
Sources: License and Collaboration Agreement (Akzo Nobel Nv)
Development Costs. (ai) 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. For the period beginning on the Effective Date and continuing through December 31Subject to this Article 4.4, 2025, the Monthly Rate for each Research Program in a particular calendar month shall be [***]. Paragon shall have the right to adjust the Monthly Rate on a bi-annual basis to account for inflation and other increases in costs by providing written notice thereof to Damora at least [***] prior to the end of the [***].
(b) On a quarterly and Research Program-by-Research Program basis, unless Damora has already paid a Cost Advance for the prior Calendar Quarter in accordance with Section 5.2(c), Paragon will deliver an invoice to Damora for the all Development Costs incurred by Paragon the Parties in the performance Development of each Research Program during such Calendar Quarterthe Product, including [***] and any [***] incurred during such Calendar Quarter in a manner consistent with the applicable Budget and Damora will pay such amount within [***] after receipt of Paragon’s invoice.
(c) At Paragon’s request, on a quarterly and Research Program-by-Research Program basis, Damora will advance to Paragon any Development Costs contemplated in the applicable Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of such Research Program during the upcoming Calendar Quarter in accordance with the applicable Research Plan and Budget (less any pre-payments for Third Party Costs from earlier Calendar Quarters that Paragon reasonably anticipates will be carried over to such upcoming Calendar Quarter) (the “Cost Advance”). Paragon’s request for the Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice to Damora Organon prior to the start of such Calendar QuarterEffective Date, and Damora will pay the Cost Advance within [***] after receipt of Paragon’s invoice.
(d) Within [***] after the end of each Calendar Quarter in which any Third Party Costs have been paid, Paragon will calculate and provide to Damora a written reconciliation on a Research Program-by-Research Program basis, of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Quarter for which any Third Party Costs have been paid (“Actual Quarterly Costs”) against the Third Party Costs paid for that Calendar Quarter, including reasonable documentation of such Actual Quarterly Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for Third Party Costs for a Research Program exceed the Actual Quarterly Costs for such Research Program, then Paragon will credit such excess payment against Development Costs contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such Research Program during any upcoming Calendar Quarter and Damora will deduct such amount from its next quarterly invoice. If the amounts paid for Third Party Costs for a Research Program are less than the Actual Quarterly Costs for such Research Program, then Paragon will invoice Damora for the difference and Damora will pay such amount together with its next quarterly invoice for such Research Program. 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 above reconciliation will not apply then- current Prior Development Costs incurred by Organon and a forecast of additional Prior Development Costs that Organon expects to Development Fees for a Research Program.
(e) Notwithstanding Sections 5.2(a), 5.2(b), 5.2(c) and 5.2(d) incur prior to the contrary, the Parties acknowledge that Paragon has incurred Effective Date. Within five (i5) approximately Ten Million Six Hundred Thousand Dollars ($10,600,000) in Development Costs through September 30, 2025, and (ii) certain additional Development Costs between October 1, 2025 and Business Days after the Effective Date, as Organon shall provide Pfizer with a result final accounting of work performed by Paragon at risk on the Research Programs listed on Exhibit A (the costs described in (i) and (ii), the “Pre-Effective Date Prior Development Costs”), and Pfizer shall have fifteen (15) Business Days to review such accounting. Damora Within twenty (20) Business Days of receipt of such accounting, Pfizer shall reimburse Paragon for the Pre-Effective Date 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 within [***] after 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 ▇▇▇▇▇▇ receipt 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 invoice notice to that details effect to Organon which notice shall identify any amounts due as a result of the Preretroactive application of the adjustment to the Parties' sharing of Development Costs set forth in subparagraph (ii) above (the "Adjustment Amount"). Within ten (10) Business Days of the date of such notice, Pfizer will 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 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 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-Effective Date 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.
(f) If a Research Program requires Paragon to perform CMC Activities in furtherance of the applicable Research Program, then Damora shall pay Paragon the CMC Monthly Fee until the full amount of the CMC Fee has been paid. On a quarterly and Research Program-by-Research Program basis, Paragon will deliver an invoice to Damora for the CMC Monthly Fees accrued for the prior Calendar Quarter and Damora will pay such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee is separate from any Development Costs or Cost Advance paid or owing with respect to a Research Program.
(g) All payments made by Damora under this Section 5.2 shall be non-refundable and non-creditable except as otherwise provide in Section 5.2(d) with respect to reconciling excess amounts paid for Third Party Costs which cannot otherwise be credited.
Appears in 1 contract
Sources: License and Collaboration Agreement
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 basisbasis 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 March 31, 2024 and continuing through December 31, 20252024, 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 a bi-an annual basis to account for inflation and other increases in costs by providing written notice thereof to Damora Oruka at least [***] days prior to the end commencement of the each [***].
(b) On a quarterly and Research Program-by-Research Program basis, unless Damora has already paid a Cost Advance for the prior Calendar Quarter in accordance with Section 5.2(c), Paragon will deliver an invoice to Damora for the Development Costs incurred by Paragon in the performance of each Research Program during such Calendar Quarter, including [***] and any [***] incurred during such Calendar Quarter in a manner consistent with the applicable Budget and Damora will pay such amount within [***] after receipt of Paragon’s invoice.
(c) At Paragon’s request, on a quarterly and Research Program-by-Research Program basis, Damora ▇▇▇▇▇ will advance to Paragon any Development Costs contemplated in the applicable Research Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of such the Research Program during the upcoming Calendar Quarter [***] in accordance with the applicable Research Plan and Research Budget (less any pre-payments for Third Party Costs from earlier Calendar Quarters [***] that Paragon reasonably anticipates will be carried over to such upcoming Calendar Quarter[***]) (the “Cost Advance”). Paragon’s request On a quarterly basis, Paragon will deliver an invoice to Oruka for the Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice to Damora prior to the start of such Calendar QuarterAdvance, and Damora Oruka will pay the Cost Advance within [***] days after receipt of Paragon’s invoice.
(dc) Within [***] days after the end of each Calendar Quarter in which any Third Party Costs have been paidYear, Paragon will calculate and provide to Damora Oruka a written reconciliation on a Research Program-by-Research Program basis, of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Quarter for which any Third Party Costs have been paid Year (“Actual Quarterly Annual Costs”) against that portion of the Cost Advance for such Third Party Costs paid for that Calendar QuarterYear, including reasonable documentation of such Actual Quarterly Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs for a Research Program exceed in the Cost Advance exceeds the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such the Research Program during any upcoming Calendar Quarter Year and Damora Oruka will deduct such amount from its next quarterly invoiceCost Advance. If the amounts paid for Third Party Costs for a Research Program are Cost Advance is less than the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will invoice Damora Oruka for the difference and Damora Oruka will pay such amount together with its next quarterly invoice for such Research ProgramCost 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 for a Research ProgramFees.
(ed) Notwithstanding Sections 5.2(a), 5.2(b), 5.2(c) and 5.2(d5.2(c) to the contrary, the Parties acknowledge have agreed that Paragon has incurred (i) approximately Ten Million Six Hundred Thousand Dollars ($10,600,000) in [***] invoice [***] of the Development Costs for the IL-23 Research Program incurred from and after the March 31, 2024 through September 30, 2025completion of the IL-23 Selection Process, and (ii) certain additional [***] of the Development Costs between October 1for the IL-23 Research Program incurred prior to March 31, 2025 and the Effective Date, as a result of work performed by Paragon at risk on the Research Programs listed on Exhibit A 2024 (the costs described in (i) and (ii), the “Pre-Effective Date 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. Damora Within [***] following completion of the IL-23 Selection Process, Paragon shall reimburse Paragon for deliver to Oruka an invoice setting forth the Pre-Effective Date IL-23 Prior Development Costs Costs, and Oruka shall pay such invoice within [***] after ▇▇▇▇▇▇’▇ following receipt of a written invoice that details the Pre-Effective Date Development Coststhereof.
(f) If a Research Program requires Paragon to perform CMC Activities in furtherance of the applicable Research Program, then Damora shall pay Paragon the CMC Monthly Fee until the full amount of the CMC Fee has been paid. On a quarterly and Research Program-by-Research Program basis, Paragon will deliver an invoice to Damora for the CMC Monthly Fees accrued for the prior Calendar Quarter and Damora will pay such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee is separate from any Development Costs or Cost Advance paid or owing with respect to a Research Program.
(g) All payments made by Damora under this Section 5.2 shall be non-refundable and non-creditable except as otherwise provide in Section 5.2(d) with respect to reconciling excess amounts paid for Third Party Costs which cannot otherwise be credited.
Appears in 1 contract
Sources: Antibody Discovery and Option Agreement (ARCA Biopharma, Inc.)
Development Costs. (a) The monthly rate On the Effective Date, Aradigm shall submit to Grifols an invoice for the Development Fees (Costs that Aradigm reasonably expects to incur during the “Monthly Rate”) shall be determined and charged on a Research Program-by-Research Program and first calendar month-by-calendar month basis. For the period beginning on quarter after the Effective Date in accordance with the Development Plan and continuing through December 31the Budget. Thereafter, 2025no 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 Monthly Rate initial invoice being payable no later than thirty (30) days following Grifols’ receipt of the invoice, and for each Research Program 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 particular calendar month 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 end of each calendar quarter while Development of an Aradigm Product for the Initial Indication is ongoing and for one calendar quarter thereafter, Aradigm shall provide to Grifols an accounting of the Development Costs actually incurred by Aradigm during such calendar quarter, such accounting to be detailed in accordance with the categories set forth in the Development Plan.
(b) 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. Paragon 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 adjust the Monthly Rate on a bi-annual basis to account for inflation include any Development Costs in excess of such one hundred and other increases in costs by providing written notice thereof to Damora at least [***] prior thirty percent (130%), to the end of the [***].
(b) On a quarterly and Research Program-by-Research Program basisextent not previously reimbursed by Grifols, unless Damora has already paid a Cost Advance for the prior Calendar Quarter in accordance with Section 5.2(c), Paragon will deliver an invoice to Damora for the Development Costs incurred by Paragon in the performance of each Research Program during such Calendar Quarter, including [***] and any [***] incurred during such Calendar Quarter in a manner consistent with the applicable Budget and Damora will pay such amount within [***] after receipt of Paragon’s invoice.
(c) At Paragon’s request, on a quarterly and Research Program-by-Research Program basis, Damora will advance to Paragon any Development Costs contemplated in the applicable Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of such Research Program invoiced during the upcoming Calendar Quarter next calendar quarter (subject, in accordance with all events, to the applicable Research Plan and Budget (less any pre-payments for Third Party Costs from earlier Calendar Quarters that Paragon reasonably anticipates will be carried over to such upcoming Calendar Quarter) (the “Cost Advance”130% limitation per quarter). Paragon’s request for the Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice Subject to Damora prior to the start of such Calendar QuarterGrifols’ rights in Section 4.3(a), and Damora will pay the Cost Advance within [***] after receipt of Paragon’s invoice.
sixty (d60) Within [***] days after the end of each Calendar Quarter calendar year, if Aradigm has incurred Development Costs in which excess of one hundred and thirty percent (130%) in any Third Party calendar quarter in such calendar year and such excess Development Costs have not been paidpaid by Grifols, Paragon will calculate and provide then, provided Aradigm provides Grifols with documentation reasonably acceptable to Damora a written reconciliation on a Research Program-by-Research Program basisGrifols verifying such Development Costs, of its actually-incurred Third Party 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 with this Agreement, in no event shall the Budget) for the prior Calendar Quarter total, aggregate Development Costs for which any Third Party Costs have been paid (“Actual Quarterly Costs”) against the Third Party Costs paid for that Calendar Quarter, including reasonable documentation of such Actual Quarterly Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for Third Party Costs for a Research Program exceed the Actual Quarterly Costs for such Research Program, then Paragon will credit such excess payment against Development Costs contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such Research Program during any upcoming Calendar Quarter and Damora will deduct such amount from its next quarterly invoice. If the amounts paid for Third Party Costs for a Research Program are less than the Actual Quarterly Costs for such Research Program, then Paragon will invoice Damora for the difference and Damora will pay such amount together with its next quarterly invoice for such Research Program. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Development Fees for a Research Program.
(e) Notwithstanding Sections 5.2(a), 5.2(b), 5.2(c) and 5.2(d) to the contrary, the Parties acknowledge that Paragon has incurred (i) approximately Ten Million Six Hundred Thousand Dollars ($10,600,000) in Development Costs through September 30, 2025, and (ii) certain additional Development Costs between October 1, 2025 and the Effective Date, as a result of work performed by Paragon at risk on the Research Programs listed on Exhibit A (the costs described in (i) and (ii), the “Pre-Effective Date Development Costs”). Damora shall reimburse Paragon for the Pre-Effective Date Development Costs within [***] after ▇▇▇▇▇▇’▇ receipt of a written invoice that details the Pre-Effective Date Development Costs.
(f) If a Research Program requires Paragon to perform CMC Activities in furtherance of the applicable Research Program, then Damora shall pay Paragon the CMC Monthly Fee until the full amount of the CMC Fee has been paid. On a quarterly and Research Program-by-Research Program basis, Paragon will deliver an invoice to Damora for the CMC Monthly Fees accrued for the prior Calendar Quarter and Damora will pay such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee Grifols is separate from any Development Costs or Cost Advance paid or owing liable under this Agreement with respect to a Research Programthe Aradigm Product for the Initial Indication exceed sixty-five million dollars ($65,000,000).
(g) All payments made by Damora under this Section 5.2 shall be non-refundable and non-creditable except as otherwise provide in Section 5.2(d) with respect to reconciling excess amounts paid for Third Party Costs which cannot otherwise be credited.
Appears in 1 contract
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. For the period beginning on the Effective Date and continuing through December 31, 2025, the Monthly Rate for each Research Program in a particular calendar month shall be Within [***]. Paragon shall have the right to adjust the Monthly Rate on a bi-annual basis to account for inflation and other increases in costs by providing written notice thereof to Damora at least [***] prior to days following the end of each calendar quarter in which the Parties incur Development Costs 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 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 then shall provide to the other Party a final report of such Development Costs within [*] days following the end of each calendar quarter. CVT shall reimburse PTC for [*] percent ([*].
(b] %) On a quarterly and Research Program-by-Research Program basis, unless Damora has already paid a Cost Advance for the prior Calendar Quarter in accordance with Section 5.2(c), Paragon will deliver an invoice to Damora for the of PTC’s Development Costs incurred by Paragon in during the performance of each Research Program during calendar quarter with respect to PTC’s activities. PTC shall invoice CVT for such Calendar Quarter, including [***] and any [***] incurred during such Calendar Quarter in a manner consistent with the applicable Budget and Damora will pay such amount PTC Development Costs within [***] after receipt of Paragon’s invoice.
(c) At Paragon’s request, on a quarterly and Research Program-by-Research Program basis, Damora will advance to Paragon any Development Costs contemplated in the applicable Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of such Research Program during the upcoming Calendar Quarter in accordance with the applicable Research Plan and Budget (less any pre-payments for Third Party Costs from earlier Calendar Quarters that Paragon reasonably anticipates will be carried over to such upcoming Calendar Quarter) (the “Cost Advance”). Paragon’s request for the Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice to Damora prior to the start of such Calendar Quarter, and Damora will pay the Cost Advance within [***] after receipt of Paragon’s invoice.
(d) Within [***] days after the end of each Calendar Quarter in which any Third Party calendar quarter. CVT shall pay all such invoices within [*] days after the end of each such calendar quarter. PTC shall reimburse CVT for [*] percent ([*] %) of CVT’s Development Costs have been paid, Paragon will calculate and provide incurred during the calendar quarter with respect to Damora a written reconciliation on a Research Program-by-Research Program basis, of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Quarter for which any Third Party Costs have been paid (“Actual Quarterly Costs”) against the Third Party Costs paid for that Calendar Quarter, including reasonable documentation of such Actual Quarterly CostsCVT’s activities. The form of such reconciliation CVT shall be subject to JDC review and approval. If the amounts paid for Third Party Costs for a Research Program exceed the Actual Quarterly Costs invoice PTC for such Research Program, then Paragon will credit such excess payment against Development Costs contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such Research Program during any upcoming Calendar Quarter and Damora will deduct such amount from its next quarterly invoice. If the amounts paid for Third Party Costs for a Research Program are less than the Actual Quarterly Costs for such Research Program, then Paragon will invoice Damora for the difference and Damora will pay such amount together with its next quarterly invoice for such Research Program. If no further amounts will be owed to Paragon hereunder, ▇▇▇▇▇▇▇ will refund such amount. For clarity, the above reconciliation will not apply to Development Fees for a Research Program.
(e) Notwithstanding Sections 5.2(a), 5.2(b), 5.2(c) and 5.2(d) to the contrary, the Parties acknowledge that Paragon has incurred (i) approximately Ten Million Six Hundred Thousand Dollars ($10,600,000) in Development Costs through September 30, 2025, and (ii) certain additional Development Costs between October 1, 2025 and the Effective Date, as a result of work performed by Paragon at risk on the Research Programs listed on Exhibit A (the costs described in (i) and (ii), the “Pre-Effective Date Development Costs”). Damora shall reimburse Paragon for the Pre-Effective Date CVT Development Costs within [**] days after the end of each calendar quarter. PTC shall pay all such invoices within [*] days after ▇▇▇▇▇▇’▇ receipt the end of each such calendar quarter; provided, however, that following PTC’s exercise of an Opt-In Right, PTC shall have the right upon written notice to CVT to delay payment of that portion of any invoice in excess of [*] percent ([*] %) of the 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 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 the entire Excess Amount is paid at the end of the sixth (6th) calendar quarter after the calendar quarter following termination of such program and for which no budget existed; and provided further, that upon the occurrence of a written invoice that details the Pre-Effective Date Development Costs.
(f) If a Research Program requires Paragon to perform CMC Activities in furtherance of milestone payment under Section 5.4 for the applicable Research ProgramCollaboration Compound or Licensed Products (but not otherwise), then Damora CVT shall deduct from the amount of such 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 owed by CVT, and PTC shall pay Paragon to CVT the CMC Monthly Fee until difference between the full remaining Excess Amount and the amount of the CMC Fee milestone that would have been owed by CVT. [*] Certain information on this page has been paidredacted and filed separately with the Securities and Exchange Commission. On a quarterly and Research Program-by-Research Program basis, Paragon will deliver an invoice to Damora for the CMC Monthly Fees accrued for the prior Calendar Quarter and Damora will pay such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee is separate from any Development Costs or Cost Advance paid or owing Confidential treatment has been requested with respect to a Research Programthe omitted portions.
(g) All payments made by Damora under this Section 5.2 shall be non-refundable and non-creditable except as otherwise provide in Section 5.2(d) with respect to reconciling excess amounts paid for Third Party Costs which cannot otherwise be credited.
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 Research Program-by-Research Program and calendar month-by-calendar month basis. For the period beginning on the Effective Date and continuing through December 31, 2025, the Monthly Rate for each Research Program in a particular calendar month shall be [***]. Paragon shall have the right to adjust the Monthly Rate on a bi-annual basis to account for inflation and other increases in costs by providing written notice thereof to Damora at least [***] prior to the end of the [***].
(b) On a quarterly and basis for each Research Program-by-Research Program basis, unless Damora has already paid a Cost Advance for the prior Calendar Quarter in accordance with Section 5.2(c), Paragon will deliver an invoice to Damora for the Development Costs incurred by Paragon in the performance of each Research Program during such Calendar Quarter, including [***] and any [***] incurred during such Calendar Quarter in a manner consistent with the applicable Budget and Damora will pay such amount within [***] after receipt of Paragon’s invoice.
(c) At Paragon’s request, on a quarterly and Research Program-by-Research Program basis, Damora Spyre will advance to Paragon any Development Costs contemplated in the applicable Budget, including [***]] of the applicable Annual Development Fee, and any [***] reasonably expected to be incurred by Paragon in the performance of such the Research Program during the upcoming Calendar Quarter in accordance with the applicable Research Plan and Budget [***] (less any pre-payments for Third Party Costs from earlier Calendar Quarters [***] that Paragon reasonably anticipates will be carried over to such upcoming Calendar Quarter[***]) (the “Cost Advance”). Paragon’s request for the Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice to Damora prior to the start of such Calendar Quarter, and Damora Spyre will pay the Cost Advance within [***] days after receipt of Paragon’s invoiceinvoice for such Development Costs. The Parties acknowledge that Paragon has incurred approximately ten million dollars ($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) 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.
(db) Within [***] days after the end of each Calendar Quarter in which any Third Party Costs have been paidYear, Paragon will calculate and provide to Damora Spyre a written reconciliation on a Research Program-by-Research Program basis, of its actually-incurred Third Party Costs (incurred in a manner consistent with the Budget) for the prior Calendar Quarter for which any Third Party Costs have been paid Year (“Actual Quarterly Annual Costs”) against that portion of the Cost Advance for such Third Party Costs paid for that Calendar QuarterYear, including reasonable documentation of such Actual Quarterly Annual Costs. The form of such reconciliation shall be subject to JDC review and approval. If the amounts paid for anticipated Third Party Costs for a Research Program exceed in the Cost Advance exceeds the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will credit such excess payment against Development Costs contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such the Research Program during any upcoming Calendar Quarter Year and Damora Spyre will deduct such amount from its next quarterly invoiceCost Advance. If the amounts paid for Third Party Costs for a Research Program are Cost Advance is less than the Actual Quarterly Costs for such Research ProgramAnnual Costs, then Paragon will invoice Damora Spyre for the difference and Damora Spyre will pay such amount together with its next quarterly invoice for such Research ProgramCost 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 for a Research ProgramFees.
(ec) Notwithstanding Sections 5.2(a), 5.2(b), 5.2(c) and 5.2(d5.2(b) to the contrary, the Parties acknowledge have agreed that Paragon has incurred (i) approximately Ten Million Six Hundred Thousand Dollars Paragon shall only invoice Spyre for fifty percent ($10,600,00050%) in of the Development Costs for the IL-23 Research Program incurred from and after April 1, 2024 through September 30, 2025completion of the IL-23 Selection Process, and (ii) certain additional Spyre shall only be responsible for fifty percent (50%) of the Development Costs between October for the IL-23 Research Program incurred prior to April 1, 2025 and 2024 provided that Paragon receives rights to at least one (1) Retained IL-23 Project Antibody following completion of the Effective Date, as a result of work performed by Paragon at risk on the Research Programs listed on Exhibit A (the costs described in (i) and (ii), the “Pre-Effective Date Development Costs”)IL-23 Selection Process. Damora shall reimburse Paragon for the Pre-Effective Date Development Costs within Within [***] after ▇▇▇▇▇▇’▇ receipt of a written invoice that details the Pre-Effective Date Development Costs.
(f) If a Research Program requires Paragon to perform CMC Activities in furtherance days following completion of the applicable Research ProgramIL-23 Selection Process, then Damora Paragon shall pay Paragon (1) deliver to Spyre a statement setting forth (x) the CMC Monthly Fee until the full total amount of the CMC Fee has been paid. On a quarterly and Research Program-by-Development Costs for the IL-23 Research Program basisincurred 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 will deliver an invoice to Damora Spyre such that Spyre shall only be responsible for fifty (50%) of the total amount of the Development Costs for the CMC Monthly Fees accrued for IL-23 Research Program incurred prior to April 1, 2024, and (2) pay to Spyre the prior Calendar Quarter and Damora will pay amounts to be reimbursed as set forth in such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee is separate from any Development Costs or Cost Advance paid or owing with respect to a Research Programstatement.
(g) All payments made by Damora under this Section 5.2 shall be non-refundable and non-creditable except as otherwise provide in Section 5.2(d) with respect to reconciling excess amounts paid for Third Party Costs which cannot otherwise be credited.
Appears in 1 contract
Sources: Antibody Discovery and Option Agreement (Spyre Therapeutics, Inc.)