Development Costs. Except as set forth in the Co-Promotion Agreement, commencing with the Fiscal Quarter beginning January 1, 2009, and occurring each Fiscal Quarter thereafter, the Parties agree to pay the Development Costs for the development and Regulatory Approval of the Licensed Product in the Field of Use as follows: Allergan shall be responsible for sixty-five percent (65%) of Development Costs incurred by Spectrum and Allergan in performing their obligations hereunder, and Spectrum is responsible for thirty-five percent (35%) of the Development Costs incurred by Spectrum and Allergan in performing their obligations hereunder. Within the first five (5) business days of each Fiscal Quarter commencing on January 1, 2009, Allergan shall pay Spectrum quarterly in advance Allergan’s share of the estimated Development Costs which Spectrum is estimated to incur for such Fiscal Quarter (as set forth in the JDP). On a monthly basis the Parties agree to discuss the Development Costs incurred in the previous month and review tracking of actual Development Costs to estimated Development Costs. The Parties shall reconcile their respective applicable Development Costs, and will deliver to the other Party, by the third business day after the new Fiscal Quarter, the backup requested by such other Party to complete such other Party’s quarterly accounting close. The estimate provided by each Party on the third business day shall be materially correct as regards actual Development Costs incurred. Within thirty (30) days after the end of each Fiscal Quarter, Allergan will provide Spectrum with an invoice representing thirty-five percent (35%) of the Development Costs incurred by Allegan during the previous Fiscal Quarter and Spectrum will process a payment to Allergan within thirty (30) days following receipt of this invoice. Within thirty (30) days after the end of each Fiscal Quarter, Spectrum shall perform a true-up to determine its actual Development Costs incurred during the previous Fiscal Quarter. If the true-up reflects actual Development Costs incurred in excess of advances previously made by Allergan, Spectrum will provide Allergan with an invoice representing the excess and Allergan will process a payment to Spectrum within thirty (30) days following receipt of this invoice. If the true-up reflects actual Development Costs incurred less than advances previously made by Allergan, Spectrum will reduce their next quarterly advance from Allergan by the amount of the shortfall. Spectrum shall bear all Development Costs for development of the Licensed Product incurred prior to January 1, 2009. In the event of a Development Trigger after which Allergan delivers notice to Spectrum under Section 10.1 for Allergan to take over development, all of the Development Costs incurred by Allergan in performing the development and Regulatory Approval services itself shall also be borne by the Parties in the ratio(s) set forth in this Section 6.6.
Appears in 2 contracts
Sources: License, Development, Supply and Distribution Agreement (Spectrum Pharmaceuticals Inc), License, Development, Supply and Distribution Agreement (Allergan Inc)
Development Costs. Except as set forth in the Co-Promotion Agreement(a) Subject to Sections 5.11(c) and 5.12, commencing with the Fiscal Quarter beginning January 1, 2009, and occurring each Fiscal Quarter thereafter, the Parties agree to pay the Development Costs for the development and Regulatory Approval of the Licensed Product in the Field of Use as follows: Allergan shall be responsible for sixty-five percent borne [*].
(65%b) In accordance with procedures to be established by the JDC, each Party shall calculate and maintain records of Development Costs incurred by Spectrum and Allergan in performing their obligations hereunder, and Spectrum is responsible for thirty-five percent (35%) of the Development Costs incurred by Spectrum and Allergan in performing their obligations hereunderit. Within the first five sixty (5) business days of each Fiscal Quarter commencing on January 1, 2009, Allergan shall pay Spectrum quarterly in advance Allergan’s share of the estimated Development Costs which Spectrum is estimated to incur for such Fiscal Quarter (as set forth in the JDP). On a monthly basis the Parties agree to discuss the Development Costs incurred in the previous month and review tracking of actual Development Costs to estimated Development Costs. The Parties shall reconcile their respective applicable Development Costs, and will deliver to the other Party, by the third business day after the new Fiscal Quarter, the backup requested by such other Party to complete such other Party’s quarterly accounting close. The estimate provided by each Party on the third business day shall be materially correct as regards actual Development Costs incurred. Within thirty (3060) days after the end of each Fiscal Quartersix-month period (ending June 30 and December 31) during which the Parties are co-developing at least one Co-Developed Product, Allergan will provide Spectrum with an invoice representing thirty-five percent (35%) of each Party shall send the other Party a report which specifies the Development Costs incurred by Allegan such Party during such six-month period with respect to each Co-Developed Product in the previous Fiscal Quarter and Spectrum will process a payment Co-Developed Territory. The Parties shall seek to Allergan resolve any questions related to such accounting statements within thirty ninety (3090) days following receipt of this invoice. Within thirty receipt.
(30c) If the reports for a particular six-month period show that one Party’s Development Costs for such six-month period were greater than [*], then the other Party (the “Reimbursing Party”) shall pay the first Party, within ninety (90) days after the end of each Fiscal Quartersuch six-month period, Spectrum shall perform a true-up an amount equal to determine its actual Development Costs incurred during [*], provided that the previous Fiscal Quarter. If the true-up reflects actual Development Costs incurred in excess of advances previously made by Allergan, Spectrum will provide Allergan with an invoice representing the excess and Allergan will process a payment to Spectrum within thirty (30) days following receipt of this invoice. If the true-up reflects actual Development Costs incurred less than advances previously made by Allergan, Spectrum will reduce their next quarterly advance from Allergan by the amount of the shortfall. Spectrum shall bear all total Development Costs for development of each Co-Developed Product for such six-month period did not exceed [*] for such product for such six-month period.
(i) If the Licensed Product incurred prior total Development Costs exceed such [*] by more than [*] for such six-month period and the Reimbursing Party’s Development Costs for such six-month period for such product were less than [*], then the Reimbursing Party shall first pay the other Party an amount equal to January 1, 2009. In the event of a Development Trigger after which Allergan delivers notice to Spectrum under Section 10.1 for Allergan to take over development, all of difference between (A) the Development Costs incurred by Allergan the Reimbursing Party for such product in performing such six-month period and (B) [*].
(ii) The Reimbursing Party’s obligation to reimburse the development and Regulatory Approval services itself other Party for [*] of all such Development Costs in excess of [*] shall also be borne limited to (A) those additional Development Costs approved by the Parties JDC (either before or after they are incurred) and (B) those additional Development Costs that are the result of work carried out in response to a governmental requirement (imposed or directed following preparation of such Development Budget) to do such work. If, after any payment by the ratio(sReimbursing Party pursuant to Section 5.11(c)(i), the Reimbursing Party’s total Development Cost expenditures, including such payment, (collectively “Z”) set forth in are less than [*] where X is [*] and Y is 100% of such reimbursable additional Development Costs, then the Reimbursing Party shall pay the other Party an amount equal to [*]. Failure of a Party to reimburse the other Party for any Development Costs that are subject to a good faith dispute hereunder shall not be deemed to be a material breach of this Section 6.6Agreement.
Appears in 2 contracts
Sources: Collaboration Agreement, Collaboration Agreement (Rigel Pharmaceuticals Inc)
Development Costs. Except as set forth in the Co-Promotion Agreement, commencing with the Fiscal Quarter beginning January 1, 2009, and occurring each Fiscal Quarter thereafter, the Parties agree to pay the (a) The parties shall share Development Costs for the development and Regulatory Approval of the Licensed Product in the Field of Use as follows: Allergan :
(i) From the Effective Date, Roche shall be responsible for sixty-five payment of eighty percent (65%) of Development Costs incurred by Spectrum and Allergan in performing their obligations hereunder, and Spectrum is responsible for thirty-five percent (3580%) of the Development Costs incurred by Spectrum * and Allergan in performing their obligations hereunder. Within the first five Agouron shall be responsible for payment of twenty percent (520%) business days of each Fiscal Quarter commencing on January 1such Development Costs; provided, 2009however, Allergan that Roche shall pay Spectrum quarterly in advance Allergan’s share of the estimated Development Costs which Spectrum is estimated to incur not be responsible for such Fiscal Quarter (as set forth in the JDP). On a monthly basis the Parties agree to discuss the Development Costs incurred for services performed before June 19, 1996, even if such services are paid for after such date. If Agouron has elected to Co-Promote a Product arising out of the Development Program for cancer indications in one or more European Co-Promotion Countries, *
(ii) Development Costs incurred for services * In addition to its twenty percent (20%) share of worldwide Development Costs because of its Co-Promotional activities in the previous month and review tracking North American Territory, *
(iii) Agouron's prorata percentage share of actual Development Costs for such European Co-Promotion Country *
(iv) Development Costs allocated to estimated Development Costs. The Parties a European Co-Promotion Country shall reconcile their respective applicable Development CostsUnless the parties agree otherwise, and will deliver to the other Party, by the third business day after the new Fiscal Quarter, the backup requested by such other Party to complete such other Party’s quarterly accounting close. The estimate provided by each Party on the third business day * shall be materially correct as regards actual Development Costs incurred. deemed to have been incurred for the benefit of the *
(b) Within thirty (30) * days after the end of a semi-annual calendar period ending on either June 30 or December 31 during which the parties have incurred Development Costs, each Fiscal Quarter, Allergan will provide Spectrum with an invoice representing thirty-five percent (35%) party shall prepare and deliver to the other party a full and true accounting of the Development Costs incurred by Allegan during the previous Fiscal Quarter and Spectrum will process a payment to Allergan within thirty (30) days following receipt of this invoice. Within thirty (30) days after the end of each Fiscal Quarter, Spectrum shall perform a true-up to determine its such party's actual Development Costs incurred during for such semi-annual period. The form of the previous Fiscal Quarter. If report shall be consistent with the true-up reflects format presented in Schedule 1 to Attachment 1, and shall detail actual Development Costs incurred by major cost categories, consistent with the accounting classifications and methods agreed upon by the parties. The accuracy of the report shall be reviewed and signed by an appropriate financial employee of the reporting party. The calculation of Development Costs shall not include any selling or marketing costs and expenses.
(c) Development Costs shall be funded and reimbursed as described in excess Attachment 1.
(d) Each party shall maintain books of advances previously made by Allerganaccount and complete and accurate records of all of its Development Costs in sufficient detail to permit the other party to confirm the correctness of such items. Each party shall provide the other party, Spectrum will provide Allergan upon reasonable request, with an invoice representing copies of invoices supporting significant third party expenditures. * To the excess and Allergan will process a payment to Spectrum within thirty (30) days following receipt of this invoice. If the true-up reflects extent actual Development Costs incurred less than advances previously vary from reported Development Costs, adjustments shall be made by Allerganto future invoices.
(e) Additional details relating to the definition, Spectrum will reduce their next quarterly advance from Allergan by the amount of the shortfall. Spectrum shall bear all calculation, reporting requirements and reimbursement procedures for Development Costs for development of the Licensed Product incurred prior to January 1, 2009. In the event of a Development Trigger after which Allergan delivers notice to Spectrum under Section 10.1 for Allergan to take over development, all of the Development Costs incurred by Allergan in performing the development and Regulatory Approval services itself shall also be borne by the Parties in the ratio(s) are set forth in this Section 6.6Attachment 1.
Appears in 1 contract
Sources: Development and License Agreement (Agouron Pharmaceuticals Inc)
Development Costs. Except as set forth in the Co-Promotion Agreement, commencing with the Fiscal Quarter beginning January 1, 2009, and occurring The Parties shall each Fiscal Quarter thereafter, the Parties agree to pay the bear fifty percent (50%) of all Development Costs for initial and subsequent indications; provided, however, that Jazz shall bear all Development Costs incurred with respect to activities that are not part of a global clinical trial and that are conducted primarily for the development and purpose of obtaining or maintaining Regulatory Approval of for the Licensed Product in within the Field Jazz Territory other than the United States or the EU. For clarity, the purpose of Use as follows: Allergan the Development activities, rather than the location where such activities are conducted, shall determine whether the associated Development Costs will be responsible for sixtyshared equally by the Parties or borne by Jazz. Each Party shall provide the other with a non-five percent (65%) binding estimate of its Development Costs incurred by Spectrum and Allergan in performing their obligations hereunder, and Spectrum is responsible for thirty-five percent (35%) of the Development Costs or to be incurred by Spectrum and Allergan in performing their obligations hereundersuch Party for each Calendar Quarter at least [***] days before the end of such Calendar Quarter. Within the first five (5) business days of each Fiscal Quarter commencing on January 1, 2009, Allergan shall pay Spectrum quarterly in advance Allergan’s share of the estimated Development Costs which Spectrum is estimated to incur for such Fiscal Quarter (as set forth in the JDP). On a monthly basis the Parties agree to discuss the Development Costs incurred in the previous month and review tracking of actual Development Costs to estimated Development Costs. The Parties shall reconcile their respective applicable Development Costs, and will deliver to the other Party, by the third business day after the new Fiscal Quarter, the backup requested by such other Party to complete such other Party’s quarterly accounting close. The estimate provided by each Party on the third business day shall be materially correct as regards actual Development Costs incurred. Within thirty (30) No later than [***] days after the end of each Fiscal Calendar Quarter, Allergan will each Party shall provide Spectrum to the other Party a reasonably detailed report showing all Development Costs incurred by such Party during the previous Calendar Quarter subject to the limitation set forth in the last sentence in this Section 6.2.1 (each such report, a “Development Costs Report”). Within [***] days after the date that both Parties have received a Development Costs Report with respect to a particular Calendar Quarter, the Party that has paid more than fifty percent (50%) of the aggregate Development Costs incurred by both Parties for the applicable Calendar Quarter shall provide the other Party with an invoice representing thirty-five for an amount equal to fifty percent (3550%) of the difference between the Development Costs incurred by Allegan during the previous Fiscal such Party for such Calendar Quarter and Spectrum will process a payment to Allergan within thirty (30) days following receipt of this invoice. Within thirty (30) days after the end of each Fiscal Quarter, Spectrum shall perform a true-up to determine its actual Development Costs incurred during the previous Fiscal Quarter. If the true-up reflects actual Development Costs incurred in excess of advances previously made by Allergan, Spectrum will provide Allergan with an invoice representing the excess and Allergan will process a payment to Spectrum within thirty (30) days following receipt of this invoice. If the true-up reflects actual Development Costs incurred less than advances previously made by Allergan, Spectrum will reduce their next quarterly advance from Allergan by the amount of the shortfall. Spectrum shall bear all Development Costs for development of the Licensed Product incurred prior to January 1, 2009. In the event of a Development Trigger after which Allergan delivers notice to Spectrum under Section 10.1 for Allergan to take over development, all of the Development Costs incurred by Allergan the other Party for such Calendar Quarter, and such other Party shall pay such invoice within [***] days of receipt, using the wire transfer provisions of Section 6.6.4. Notwithstanding the foregoing, in performing no event shall a Party be required 5 Include applicable amount of Jazz Option Exercise Fee under the development Collaboration and Regulatory Approval services itself shall also be borne Option Agreement. 6 [***] to reimburse the other Party for Development Costs incurred by such other Party in any Calendar Quarter in excess of [***] of the Parties in the ratio(s) amount set forth in this Section 6.6the Development Plan Budget for such Calendar Quarter for the activities for which the other Party is responsible under the Development Plan, as the Development Plan and Development Plan Budget may be amended from time to time. If a Party anticipates incurring costs in excess of [***] of the amount set forth in the Development Plan Budget for activities for which such Party is responsible under the Development Plan, (i) such Party shall notify the other Party and may request an increase the Development Plan Budget to cover such excess costs, (ii) the other Party shall consider such request in good faith and shall not deny such request to the extent that such excess costs are due to unforeseeable events outside of the reasonable control of such Party, and (iii) such Party shall continue to be responsible for the performance of such activities under the Development Plan and, unless the Parties mutually agree to an amendment to the Development Plan and Development Plan Budget, such Party shall be responsible for [***] of such excess costs.
Appears in 1 contract
Development Costs. Except as set forth Within [***] after the end of each Calendar Quarter during which a Party (the “Incurring Party”) incurs any Development Costs that are subject to reimbursement by the other Party in the Co-Promotion Agreement, commencing accordance with the Fiscal Quarter beginning January 1, 2009, and occurring each Fiscal Quarter thereafterSection 4.3, the Parties agree Incurring Party shall submit to pay the Development Costs for the development and Regulatory Approval of the Licensed Product in the Field of Use as follows: Allergan shall be responsible for sixty-five percent (65%) of Development Costs incurred by Spectrum and Allergan in performing their obligations hereunder, and Spectrum is responsible for thirty-five percent (35%) other Party a reasonably detailed report of the Development Costs incurred by Spectrum such Incurring Party or its Affiliates in accordance with this Agreement in such Calendar Quarter together with reasonable supporting documentation and Allergan in performing their obligations hereunder. Within the first five (5) business days of each Fiscal Quarter commencing on January 1, 2009, Allergan shall pay Spectrum quarterly in advance Allergan’s share of the estimated Development Costs which Spectrum is estimated to incur an invoice for such Fiscal Quarter (as set forth in the JDP). On a monthly basis the Parties agree to discuss the Development Costs incurred in the previous month and review tracking of actual Development Costs to estimated Development Costs. The Parties For the avoidance of doubt, no cost or expense shall reconcile their respective applicable be counted more than once in calculating Development Costs, even if such costs or expense falls into more than one of the cost categories that comprise Development Costs. Each Party shall record and will deliver account for its FTE effort to the extent that such FTE efforts are included in Development Costs that are shared under this Agreement, and shall report such FTE effort to the JSC, if requested (such request not to be more than on a [***] basis). Each Party shall calculate and maintain records of FTE effort incurred by it in the same manner as used for other products developed by such Party, unless instructed by the third business day after the new Fiscal QuarterJSC to employ other procedures, the backup requested by in which case such other Party procedures shall be applied equally to complete such other Party’s quarterly accounting closeboth Parties. The estimate provided by each other Party on the third business day shall be materially correct as regards actual Development Costs incurred. Within thirty (30) days after the end of each Fiscal Quarter, Allergan will provide Spectrum with an invoice representing thirty-five percent (35%) pay its portion of the Development Costs incurred by Allegan during in the previous Fiscal Quarter and Spectrum will process a payment to Allergan amount invoiced within thirty (30) days following [***] after receipt of this such invoice. Within thirty (30) days after the end of each Fiscal Quarter, Spectrum Each Party shall perform (or shall procure the performance of) such further acts, and to execute and deliver (or to procure the execution and delivery of) such further agreements and documents, as may be required by Applicable Law or as the other Party may reasonably require to implement such payment. Notwithstanding the foregoing, a true-up Party may withhold amounts that are subject to determine its actual Development Costs incurred during the previous Fiscal Quartera good faith dispute. If the true-up reflects actual Parties cannot agree on the reimbursement of Development Costs incurred in excess of advances previously made by AllerganCosts, Spectrum will provide Allergan with an invoice representing the excess and Allergan will process a payment to Spectrum within thirty (30) days following receipt of this invoice. If the true-up reflects actual Development Costs incurred less than advances previously made by Allergan, Spectrum will reduce their next quarterly advance from Allergan by the amount of the shortfall. Spectrum shall bear all Development Costs for development of the Licensed Product incurred prior to January 1, 2009. In the event of a Development Trigger after which Allergan delivers notice to Spectrum under Section 10.1 for Allergan to take over development, all of the Development Costs incurred by Allergan in performing the development and Regulatory Approval services itself shall also be borne by the Parties shall resolve such dispute in the ratio(s) set forth in this Section 6.6accordance with Article 15.
Appears in 1 contract
Sources: Collaboration and License Agreement (Molecular Partners Ag)
Development Costs. Except as set forth (a) Orexigen shall bear all Development Costs incurred by either or both of the Parties in the Co-Promotion Agreement, commencing with the Fiscal Quarter beginning January conduct of […***…].
(b) The Parties have shared all Development Costs incurred prior to August 1, 20092015 by either or both of the Parties in the conduct of Development Post- Approval Activities in accordance with Section 2.2.2(b) of the Original Collaboration Agreement. As of August 1, and occurring each Fiscal Quarter thereafter2015, the Parties agree to pay the shall share all Development Costs incurred from and after August 1, 2015 by either or both of the Parties in the conduct of […***…] during the Term as follows:
(i) Orexigen shall bear all such Development Costs incurred by Takeda (and all Development Costs incurred by Orexigen with respect to the Manufacture of Product for the development and Regulatory Approval CVOT PMR Study by its Third Party Manufacturer(s)) in the conduct of the Licensed Product in the Field of Use as follows: Allergan shall be responsible for sixty-five percent CVOT PMR Study up to an aggregate amount equal to Two Hundred Ten Million Dollars (65%$210,000,000).
(ii) After Orexigen has borne Two Hundred Ten Million Dollars ($210,000,000) of Development Costs incurred by Spectrum Takeda (and Allergan Development Costs incurred by Orexigen with respect to the Manufacture of Product for the CVOT PMR Study by its Third Party Manufacturer(s)) in performing their obligations hereunderthe conduct of the CVOT PMR Study, each Party shall bear fifty percent (50%) of such Development Costs incurred by Takeda (and Spectrum Development Costs incurred by Orexigen with respect to the Manufacture of Product for the CVOT PMR Study by its Third Party Manufacturer(s)) in the conduct of the CVOT PMR Study.
(iii) Notwithstanding Section 2.2.2(b)(i) and (ii), if Takeda and Orexigen agree to amend the design of the CVOT PMR Study (and for clarity, the Development Plan) […***…].
(iv) Notwithstanding Section 2.2.2(b)(i) and (ii), subject to approval by the FDA, if the […***…] approves an amended Development Plan, which includes an amendment to the CVOT PMR Study such that it is responsible for thirtydesigned to achieve Superiority, then in such case, […***…] […***…].
(v) Takeda shall bear seventy-five percent (3575%) and Orexigen shall bear twenty-five percent (25%) of the such Development Costs incurred by Spectrum and Allergan in performing their obligations hereunder. Within the first five (5) business days of each Fiscal Quarter commencing on January 1, 2009, Allergan shall pay Spectrum quarterly in advance Allergan’s share either or both of the estimated Development Costs which Spectrum is estimated to incur for such Fiscal Quarter (as set forth Parties in the JDPconduct of (a) Non-CVOT PMR Studies; (b) life cycle management activities; and (c) Development Post-Approval Activities other than as provided in Section 2.2.2(b)(i). On a monthly basis the Parties agree to discuss the , (ii), (iii) and (iv), and Section 2.2.2(b)(vi).
(vi) Takeda shall bear all such Development Costs incurred by Takeda (and all Development Costs incurred by Orexigen with respect to the Manufacture of Product for the Light Study by its Third Party Manufacturer(s)) in the previous month and review tracking conduct of actual Development Costs to estimated Development Costs. The Parties shall reconcile their respective applicable Development Costs, and will deliver activities related to the other Party, by the third business day after the new Fiscal Quarter, the backup requested by such other Party to complete such other Party’s quarterly accounting close. The estimate provided by each Party on the third business day shall be materially correct as regards actual Development Costs incurred. Light Study.
(c) Within thirty […***…] (30[…***…]) days after the end of each Fiscal Calendar Quarter, Allergan each Party will provide Spectrum with an invoice representing thirty-five percent (35%) of a written report to the other Party setting forth in reasonable detail the recorded Development Costs incurred by Allegan during the previous Fiscal relating to such Calendar Quarter and Spectrum will process (each, a payment to Allergan within thirty (30) days following receipt of this invoice“Quarterly Report”). Within thirty […***…] (30[…***…]) days after the end of each Fiscal such Calendar Quarter, Spectrum shall perform a true-up to determine its actual Development Costs incurred during the previous Fiscal Quarter. If Parties will agree upon the true-up reflects actual Development Costs incurred in excess of advances previously made by Allergan, Spectrum will provide Allergan with an invoice representing the excess such Calendar Quarter and Allergan will process a payment any amount required to Spectrum be paid to give effect to Section 2.2.2(b). Such amount shall be paid within thirty […***…] (30[…***…]) days following receipt after the Parties agree upon such amount.
(d) In the event either Orexigen or Takeda discover a need for correction in calculating the amount of this invoiceDevelopment Costs incurred by such Party during any previous […***…], it will promptly notify the other Party of such discovery. The Parties will then discuss the validity and appropriateness of the correction. If the true-up reflects actual Parties agree that such correction should be made and mutually verify the amount to be corrected, then such amounts shall be included in the following […***…] reconciliation between the Parties as set forth in Section 2.2.2(c); provided, however, only corrections for Development Costs incurred less that have occurred in the previous […***…] prior to the date of the notice described in the first sentence of this subsection (d) shall be eligible for correction. If the Parties do not agree on the validity or appropriateness of the requested correction, the JDC will be responsible for deciding the issue.
(e) Each Party will use Commercially Reasonable Efforts to complete the Development activities contemplated in the Development Plan and related budget, and to do so within the amounts budgeted. The Parties acknowledge that actual expenditures may differ from budgeted amounts, and accordingly agree that the aggregate amount actually spent by a Party may be up to […***…] percent ([…***…]%) higher than advances previously made by Allergan, Spectrum will reduce their next quarterly advance from Allergan by the amount of specified in the shortfall. Spectrum shall bear all Development Costs for development of the Licensed Product incurred prior to January 1, 2009budget. In the event of a Development Trigger after which Allergan delivers notice to Spectrum under Section 10.1 for Allergan to take over development, all of the Party’s Development Costs incurred in the aggregate exceed the amount budgeted in any Development Plan by Allergan in performing more than […***…] percent ([…***…]%), the development and Regulatory Approval services itself JDC shall also determine if such excess amount is reasonable under the circumstances. If the JDC determines such excess amounts are reasonable, such amounts shall be deemed Development Costs; otherwise, the excess shall be borne by the Parties in the ratio(s) set forth in this Section 6.6Party that incurred such excess Development Costs.
Appears in 1 contract
Sources: Collaboration Agreement (Orexigen Therapeutics, Inc.)
Development Costs. Except as set forth in the Co-Promotion Agreement, commencing with the Fiscal Quarter beginning January 1, 2009, and occurring each Fiscal Quarter thereafter, the The Parties agree to pay the shall share Development Costs for incurred by or on behalf of either Party or its Affiliates after the development and Regulatory Approval Effective Date solely to the extent related to Development of the Licensed Product Compounds or Licensed Products in the Field of Use Territory, such sharing to be as follows: Allergan (1) for Development Costs incurred prior to the Amendment Effective Date, Gilead shall be responsible for sixty-five eighty percent (6580%) of and Galapagos shall be responsible for twenty percent (20%) and (2) for Development Costs incurred by Spectrum and Allergan in performing their obligations hereunderon or after the Amendment Effective Date, and Spectrum is each Party shall be responsible for thirty-five fifty percent (3550%) (regardless of the Development Costs incurred by Spectrum and Allergan in performing their obligations hereunderdate of invoice or payment). Within the first five (5) business days of each Fiscal Quarter commencing on January 1, 2009, Allergan shall pay Spectrum quarterly in advance Allergan’s share of the estimated Development Costs which Spectrum is estimated to incur for such Fiscal Quarter (as set forth in the JDP). On a monthly basis the Parties agree to discuss the Development Costs incurred in the previous month and review tracking of actual Development Costs to estimated Development Costs. The Parties shall reconcile their respective applicable Development Costs, and will deliver to the other Party, by the third business day after the new Fiscal Quarter, the backup requested by such other Party to complete such other Party’s quarterly accounting close. The estimate provided by each Party on the third business day shall be materially correct as regards actual Development Costs incurred. Within thirty (30) days […***…] Business Days after the end of each Fiscal Quartercalendar quarter, Allergan will each Party shall provide Spectrum with an invoice representing thirty-five percent (35%) to the other Party a report in reasonable detail of the any Development Costs incurred by Allegan during such Party in such calendar quarter for each Licensed Product. The Development Costs so reported will be used for the previous Fiscal Quarter and Spectrum will process a payment to Allergan within thirty (30) days following receipt calculation of this invoicethe 80%/20% split or the 50%/50% split for the Development Costs, as applicable. Within thirty (30) days […***…] Business Days after the end of each Fiscal Quartercalendar quarter, Spectrum Gilead shall perform send Galapagos a true-up to determine its actual consolidated report in reasonable detail regarding such Development Costs incurred during the previous Fiscal Quarterby each Party for such calendar quarter. If the true-up reflects actual Development Costs incurred in excess of advances previously made by Allergan, Spectrum will provide Allergan with an invoice representing the excess and Allergan will process a payment to Spectrum within thirty (30) Within […***…] days following receipt of such report, the Party whose Development Cost expenditures exceed the portion of the total such expenditures by both Parties for such calendar quarter allocated to such Party in this invoice. If Section 3.4 shall invoice the true-up reflects actual Development Costs incurred less than advances previously made by Allergan, Spectrum will reduce their next quarterly advance from Allergan by other Party for the amount of the shortfallfunds necessary to account for such excess. Spectrum The Party receiving such invoice shall bear pay it not later than […***…] days following receipt thereof. For clarity, Gilead shall be solely responsible for all Development Costs for development costs and expenses incurred by or on behalf of the Licensed Product incurred prior to January 1, 2009. In the event of a Development Trigger after which Allergan delivers notice to Spectrum under Section 10.1 for Allergan to take over development, all of Gilead in the Development Costs incurred by Allergan in performing the development and Regulatory Approval services itself shall also be borne by the Parties of Gilead Combination Products in the ratio(s) set forth in this Section 6.6Territory. […***…].
Appears in 1 contract
Development Costs. Except as set forth in the Co-Promotion Agreement, commencing with the Fiscal Quarter beginning January 1, 2009, and occurring each Fiscal Quarter thereafter, the Parties agree to pay the (a) The parties shall share Development Costs for the development and Regulatory Approval of the Licensed Product in the Field of Use as follows: Allergan :
(i) From the Effective Date, Roche shall be responsible for sixty-five payment of eighty percent (65%) of Development Costs incurred by Spectrum and Allergan in performing their obligations hereunder, and Spectrum is responsible for thirty-five percent (3580%) of the Development Costs incurred by Spectrum * and Allergan in performing their obligations hereunder. Within the first five Agouron shall be responsible for payment of twenty percent (520%) business days of each Fiscal Quarter commencing on January 1such Development Costs; provided, 2009however, Allergan that Roche shall pay Spectrum quarterly in advance Allergan’s share of the estimated Development Costs which Spectrum is estimated to incur not be responsible for such Fiscal Quarter (as set forth in the JDP). On a monthly basis the Parties agree to discuss the Development Costs incurred for services performed before June 19, 1996, even if such services are paid for after such date. If Agouron has elected to Co-Promote a Product arising out of the Development Program for cancer indications in one or more European Co-Promotion Countries, *
(ii) Development Costs incurred for services * In addition to its twenty percent (20%) share of worldwide Development Costs because of its Co-Promotional activities in the previous month and review tracking North American Territory, *
(iii) Agouron's prorata percentage share of actual Development Costs for such European Co-Promotion Country *
(iv) Development Costs allocated to estimated Development Costs. The Parties a European Co-Promotion Country shall reconcile their respective applicable Development Costs* Unless the parties agree otherwise, and will deliver to the other Party, by the third business day after the new Fiscal Quarter, the backup requested by such other Party to complete such other Party’s quarterly accounting close. The estimate provided by each Party on the third business day * shall be materially correct as regards actual Development Costs incurred. deemed to have been incurred for the benefit of *
(b) Within thirty (30) * days after the end of a semi-annual calendar period ending on either June 30 or December 31 during which the parties have incurred Development Costs, each Fiscal Quarter, Allergan will provide Spectrum with an invoice representing thirty-five percent (35%) party shall prepare and deliver to the other party a full and true accounting of the Development Costs incurred by Allegan during the previous Fiscal Quarter and Spectrum will process a payment to Allergan within thirty (30) days following receipt of this invoice. Within thirty (30) days after the end of each Fiscal Quarter, Spectrum shall perform a true-up to determine its such party's actual Development Costs incurred during for such semi-annual period. The form of the previous Fiscal Quarter. If report shall be consistent with the true-up reflects format presented in Schedule 1 to Attachment 1, and shall detail actual Development Costs incurred by major cost categories, consistent with the accounting classifications and methods agreed upon by the parties. The accuracy of the report shall be reviewed and signed by an appropriate financial employee of the reporting party. The calculation of Development Costs shall not include any selling or marketing costs and expenses.
(c) Development Costs shall be funded and reimbursed as described in excess Attachment 1.
(d) Each party shall maintain books of advances previously made by Allerganaccount and complete and accurate records of all of its Development Costs in sufficient detail to permit the other party to confirm the correctness of such items. Each party shall provide the other party, Spectrum will provide Allergan upon reasonable request, with an invoice representing copies of invoices supporting significant third party expenditures. * To the excess and Allergan will process a payment to Spectrum within thirty (30) days following receipt of this invoice. If the true-up reflects extent actual Development Costs incurred less than advances previously vary from reported Development Costs, adjustments shall be made by Allerganto future invoices.
(e) Additional details relating to the definition, Spectrum will reduce their next quarterly advance from Allergan by the amount of the shortfall. Spectrum shall bear all calculation, reporting requirements and reimbursement procedures for Development Costs for development of the Licensed Product incurred prior to January 1, 2009. In the event of a Development Trigger after which Allergan delivers notice to Spectrum under Section 10.1 for Allergan to take over development, all of the Development Costs incurred by Allergan in performing the development and Regulatory Approval services itself shall also be borne by the Parties in the ratio(s) are set forth in this Section 6.6Attachment 1.
Appears in 1 contract
Sources: Development and License Agreement (Agouron Pharmaceuticals Inc)
Development Costs. Except as set forth in (a) The monthly rate for the CoDevelopment Fees (the “Monthly Rate”) shall be determined and charged on a Research Program-Promotion Agreementby-Research Program and calendar month-by-calendar month basis. For the period beginning on the Effective Date and continuing through December 31, commencing with the Fiscal Quarter beginning January 1, 2009, and occurring each Fiscal Quarter thereafter2025, the Parties agree Monthly Rate for each Research Program in a particular calendar month shall be [***]. Paragon shall have the right to pay adjust the Development Costs Monthly Rate on a bi-annual basis to account for inflation and other increases in costs by providing written notice thereof to Crescent at least [***] prior to [***].
(b) On a quarterly and Research Program-by-Research Program basis, unless Crescent has already paid a Cost Advance for the development and Regulatory Approval of the Licensed Product prior [***] in the Field of Use as follows: Allergan shall be responsible accordance with Section 5.2(c), Paragon will deliver an invoice to Crescent for sixty-five percent (65%) of Development Costs incurred by Spectrum and Allergan in performing their obligations hereunder, and Spectrum is responsible for thirty-five percent (35%) of the Development Costs incurred by Spectrum and Allergan Paragon in performing their obligations hereunder. Within the first five (5) business days of each Fiscal Quarter commencing on January 1, 2009, Allergan shall pay Spectrum quarterly in advance Allergan’s share performance of the estimated Research Program during such [***], including [***] and any [***] incurred during such [***] in a manner consistent with the Budget, and Crescent 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, Crescent will advance to Paragon any Development Costs which Spectrum is estimated to incur for such Fiscal Quarter (as set forth contemplated in the JDPapplicable Budget, including [***], and any [***] reasonably expected to be incurred by Paragon in the performance of such Research Program during the upcoming [***] in accordance with the applicable Research Plan and Budget (less any pre-payments for [***] from earlier [***] that Paragon reasonably anticipates will be carried over to such upcoming [***]) (the “Cost Advance”). On a monthly basis Paragon’s request for the Parties agree Cost Advance for an upcoming Calendar Quarter will be made by delivering an invoice to discuss Crescent prior to the Development Costs incurred in the previous month and review tracking start of actual Development Costs to estimated Development Costs. The Parties shall reconcile their respective applicable Development Costssuch Calendar Quarter, and Crescent will deliver to pay the other Party, by the third business day Cost Advance within [***] after the new Fiscal Quarter, the backup requested by such other Party to complete such other Partyreceipt of Paragon’s quarterly accounting close. The estimate provided by each Party on the third business day shall be materially correct as regards actual Development Costs incurred. invoice.
(d) Within thirty (30) days [***] after the end of each Fiscal Calendar Quarter in which any Third Party Costs have been paid, Paragon will calculate and provide to 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 (“Actual Quarterly Costs”) against the Third Party Costs paid for that Calendar Quarter, Allergan will provide Spectrum with an invoice representing thirty-five percent (35%) including reasonable documentation of the Development Costs incurred by Allegan during the previous Fiscal Quarter such Actual Quarterly Costs. The form of such reconciliation shall be subject to JDC review and Spectrum will process a payment to Allergan within thirty (30) days following receipt of this invoice. Within thirty (30) days after the end of each Fiscal Quarter, Spectrum shall perform a true-up to determine its actual Development Costs incurred during the previous Fiscal Quarterapproval. If the true-up reflects actual amounts paid for Third Party Costs for a Research Program exceeds 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 excess the performance of advances previously made by Allergan, Spectrum such Research Program during any upcoming Calendar Quarter and Crescent will provide Allergan with an deduct such amount from its next quarterly invoice representing the excess and Allergan will process a payment to Spectrum within thirty (30) days following receipt of this invoicefor such Research Program. If the true-up reflects actual amounts paid for Third Party Costs for a Research Program is less than the Actual Quarterly Costs for such Research Program, then Paragon will invoice Crescent for the difference and Crescent will pay such amount together with its next quarterly invoice for such Research Program. If no further amounts will be owed to Paragon hereunder, P▇▇▇▇▇▇ 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 certain Development Costs incurred less than advances previously made prior to the A&R Effective Date as a result of work performed by AllerganParagon at risk on Research Program #1 and Research Program 2 (collectively, Spectrum will reduce their next quarterly advance from Allergan by the “Research Programs #1 & 2 Pre-Effective Date Development Costs”). Crescent shall reimburse Paragon for the Research Programs #1 & 2 Pre-Effective Date Development Costs within [***] after Crescent’s receipt of a written invoice that details the Research Programs #1 & 2 Pre-Effective Date Development Costs.
(f) If a Research Plan requires Paragon to perform CMC Activities in furtherance of the applicable Research Program, then Crescent shall pay to Paragon the CMC Monthly Fee until the full amount of the shortfallCMC Fee has been paid. Spectrum shall bear all On a quarterly and Research Program-by-Research Program basis, Paragon will deliver an invoice to Crescent for the CMC Monthly Fees accrued for the prior Calendar Quarter, and Crescent will pay such amount within [***] after receipt of Paragon’s invoice. For clarity, the CMC Fee is separate from any Development Costs for development of the Licensed Product incurred prior or Cost Advance paid or owing with respect to January 1, 2009. In the event of a Development Trigger after which Allergan delivers notice to Spectrum Research Program.
(g) All payments made by Crescent under Section 10.1 for Allergan to take over development, all of the Development Costs incurred by Allergan in performing the development and Regulatory Approval services itself shall also be borne by the Parties in the ratio(s) set forth in this Section 6.65.2 shall be non-refundable and non-creditable except as otherwise provided 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)