Common use of Ordering/Forecasting Clause in Contracts

Ordering/Forecasting. (i) Except as is set forth below with regard to the Initial Quantity during the Supply Term, at least [* * *] ([* * *]) days prior to the start of each calendar month, PAR shall provide GSK (or its Affiliate) with a written firm order for such upcoming calendar month. By the first of each calendar month, PAR shall also provide GSK (or its Affiliate) with a written estimate of the quantities of GSK Supplied Product in the Territory PAR and its Affiliates require for the next succeeding [* * *] ([* * *]) months on a monthly basis (in the forecast format set forth on Schedule 4.2(c)) (the “Forecast”). Each of such Forecast shall contain the applicable [* * *] ([* * *]) calendar months firm orders and the remaining [* * *] ([* * *]) non-binding monthly estimates for that applicable period. When PAR shall place a firm order with GSK (or its Affiliate) for its GSK Supplied Product requirements at least [* * *] ([* * *]) days in advance of the start of each calendar month, GSK (or its Affiliate) shall respond to PAR within [* * *] ([* * *]) Business Days after receipt of such firm order, and in the event GSK (or its Affiliate) responds other than by accepting the firm order, the Parties shall cooperate and use good faith efforts to meet as closely as reasonably possible the Reasonable Quantity Requirements and schedule for delivery specified in the firm order, subject to the provisions of subsections (ii) below. Once a firm order is agreed upon by the Parties, PAR shall amend the firm order to reflect the quantity and delivery schedule agreed by the Parties and send to GSK (or its Affiliates) such revised firm order and a purchase order covering such quantities and delivery date, and GSK (or its Affiliate) shall have the obligation to supply such quantity to PAR pursuant to the terms hereof. PAR shall promptly reimburse GSK for any and all documented, reasonable costs and expenses incurred by GSK (or its Affiliate) that arise from any canceled or materially modified firm order (without GSK’s prior written consent) after acceptance thereof by GSK (or its Affiliate), including all obsolete material that can not be reasonably utilized by GSK or its Affiliate. The previous sentence shall not limit GSK’s remedies or damages in the event PAR cancels or materially modifies any firm order, and PAR shall not modify or cancel the last firm order in the Supply Term. In the event the Parties reasonably agree that a Third Party Generic Sumatriptan Product is likely to in the immediate future, or has, become available for commercial sale in the Territory, the Parties shall in good faith review and adjust the then-existing Forecast in light of the presence of such Third Party Generic Sumatriptan Product in the Territory, provided the Parties shall use their commercially reasonable efforts to mitigate all losses and expenses related to such revisions to the Forecast. The last firm order and Forecast shall be received and agreed by GSK not less than [* * *] ([* * *]) days prior to the Supply Termination Date. The firm orders for the last [* * *] ([* * *]) months of the Supply Term shall each not exceed [* * *] percent ([* * *]%) of the average monthly demand for GSK Supplied Product over the prior twelve (12) month period (determined on a sku-by-sku basis), unless PAR can provide reasonable evidence to GSK that there is adequate demand over the remainder of the Supply Term for GSK Supplied Product in excess of such limits. Upon termination or expiration of this Agreement, all firm orders and Forecasts are to be automatically terminated, except to the extent that backordered firm orders remain unfilled. PAR acknowledges and agrees that GSK relies on the [* * *] ([* * *]) month firm zone orders provided by PAR for the purpose of manufacturing planning and ordering necessary materials and components for the production of GSK Supplied Product. In the event PAR does not issue purchase orders in a timely manner (as described in this Section 4.2(c)) covering any [* * *] ([* * *]) month firm zone, PAR agrees that in the event GSK decides in its sole discretion to waive the firm zone requirements set forth herein: (A) GSK is entitled to reasonably rely upon the applicable [* * *] month firm zone last provided by PAR in the Forecast for the purpose of manufacturing planning and ordering necessary materials and components for the production of GSK Supplied Product and (B) in the event GSK is unable to reasonably utilize any such materials and components in the event PAR’s purchase orders are less than as set forth in the firm orders for such [* * *] ([* * *]) month firm zone, PAR shall reimburse GSK for all reasonable out-of-pocket costs incurred by GSK for any such obsolete materials and components, provided GSK uses its reasonable efforts to mitigate the costs associated with such obsolete materials and components. For the avoidance of doubt, GSK shall, in its sole discretion, decide whether or not it (or its Affiliates) will supply PAR with GSK Supplied Product absent purchase orders issued in a timely manner (as described in this Section 4.2(c)) for any [* * *] ([* * *]) month firm zone, however GSK shall reasonably consider supplying PAR in such instance, consistent with GSK’s reasonable ability to do so. (ii) Each purchase order shall specify a delivery date which shall be at least [* * *] ([* * *]) days after the date of the purchase order. Should a purchase order call for shipment of quantities of GSK Supplied Product in excess of [* * *] percent ([* * *]%) of the immediately preceding estimated requirements previously provided to GSK (or its Affiliate) in the Forecast, GSK (or its Affiliate) will use its Commercially Reasonable Efforts, but shall not be obligated, to supply that portion of excess by the dates instructed by PAR; provided, however, in no event shall GSK (or its Affiliates) have any obligation to forego manufacture of any GSK (or its Affiliates’) products on common equipment that would have a material adverse consequence to GSK business in order to deliver GSK Supplied Product to PAR or its Affiliates in excess of the preceding Forecast. Notwithstanding anything to the contrary, PAR’s first firm orders for the [* * *] ([* * *]) month firm zone for GSK Supplied Product from GSK shall be in the quantities specified in Schedule 4.2(d). GSK (and its Affiliates) shall not be obligated to supply to PAR (or its Affiliates) quantities of GSK Supplied Product in excess of GSK’s (or its Affiliate’s) branded Imitrex® [* * *] product ([* * *]presentations) manufacturing capacity (with such capacity being defined herein as GSK’s [* * *] product ([* * *] presentations) capacity without regard to individual presentation capacity – all subject to PAR’s compliance with the forecasting and firm order requirements in this Agreement). In no event shall such capacity be less than such capacity existing as of the Execution Date. (iii) Delivery of GSK Supplied Product ordered hereunder from GSK (or its Affiliate) to PAR and its Affiliates shall be [***] (Incoterms 2000), whereby [***] and [***] shall bear all risk of loss or damage, and costs of insurance and shipping associated with the GSK Supplied Product [***]. (iv) Attached hereto as Schedule 4.2(d), is PAR’s current good faith non-binding estimate of its (and its Affiliates’) requirements of GSK Supplied Product for the Territory for the [* * *] ([* * *]) months (including the Initial Quantity) following the Launch Date and the remainder of the Forecast. Following the Execution Date, PAR shall provide GSK an updated version of the Forecast on a [* * *] basis. [* * *] ([* * *]) days after the later of (A) [***] and (B) the date GSK notifies PAR of its ability (or inability) to supply PAR with the Generic [* * *] Product in the [* * *], PAR shall provide GSK with a definitive Forecast (in the form applicable to such Launch Date) and binding purchase orders for the [* * *] ([* * *]) months following the Launch Date (such total to include the Initial Quantity) and such Forecast and binding purchase orders shall not vary by more than [* * *] percent ([* * *]%) from the last non-binding Forecast provided to GSK (as determined on a monthly basis) subject to the last sentence of the first paragraph of Section 4.2(c)(i). (v) In ordering and delivering GSK Supplied Product, as the case may be, GSK (or its Affiliates) and PAR may use their respective standard forms and documents in ordering and delivering the GSK Supplied Product, provided that nothing in those forms or documents shall be construed to modify or amend the terms and conditions of this Agreement, and, in the case of any conflict herewith, the terms and conditions of this Agreement shall control.

Appears in 1 contract

Sources: Supply and Distribution Agreement (Spectrum Pharmaceuticals Inc)

Ordering/Forecasting. Cephalon shall inform ▇▇▇▇, the Commission, and any Interim Monitor, in writing every sixty (60) days from the Effective Date until FDA approval of: (1) ▇▇▇▇ Generic Product and (2) ▇▇▇▇ Generic SF Product, concerning the date of Anticipated Final FDA Approval of OVF. ▇▇▇▇ shall immediately notify Cephalon of the receipt of FDA ANDA Approval of ▇▇▇▇ Generic Product and ▇▇▇▇ generic SF Product. Cephalon shall immediately notify ▇▇▇▇, the Commission, and any Interim Monitor, in writing, upon the occurrence of each of the following events: (i) Except as submission of the NDA for OVF, (ii) receipt of a FDA Approvable Letter for OVF, (iii) Final FDA Approval of OVF, (iv) any determination by the FDA that ACTIQ may no longer be sold in the United States; and (v) any determination by the FDA that ACTIQ is set forth below not A/B Rated to ACTIQ SF. Failure of Cephalon to provide ▇▇▇▇ with regard such notifications shall constitute material breach. Commencing [**] months prior to the Initial Quantity during the Supply TermAnticipated Final FDA Approval of OVF, at least as provided by Cephalon, ▇▇▇▇ shall provide Cephalon with rolling [* * **] month forecast of its requirements of Cephalon Supplied Products. The forecasts shall be updated [**] and shall be provided to Cephalon not less than [**] ([* * **]) days months prior to the start first requested delivery of product under the then-current forecasts. In addition, the first [**] months of each calendar month, PAR forecast shall provide GSK (or its Affiliate) with a written be firm order for such upcoming calendar monthpurchase orders binding on ▇▇▇▇ and Cephalon. By the first of each calendar month, PAR shall also provide GSK (or its Affiliate) with a written estimate of the quantities of GSK Supplied Product in the Territory PAR and its Affiliates require for the next succeeding Within [* * **] ([* * **]) months on a monthly basis (in the forecast format set forth on Schedule 4.2(c)) (the “Forecast”). Each business days of such Forecast shall contain the applicable [* * *] ([* * *]) calendar months firm orders and the remaining [* * *] ([* * *]) non-binding monthly estimates for that applicable period. When PAR shall place a firm order with GSK (or its Affiliate) for its GSK Supplied Product requirements at least [* * *] ([* * *]) days in advance of the start receipt of each calendar monthforecast from ▇▇▇▇, GSK (or its Affiliate) Cephalon and ▇▇▇▇ shall respond to PAR within [* * *] ([* * *]) Business Days after receipt of such firm order, and in discuss the event GSK (or its Affiliate) responds other than by accepting the firm order, the Parties shall cooperate and use good faith efforts to meet as closely as reasonably possible the Reasonable Quantity Requirements and manufacturing schedule for delivery specified in the firm order, subject to the provisions of subsections (ii) belowCephalon Supplied Products. Once a firm order is agreed upon by the Parties, PAR Cephalon shall amend the firm order to reflect the quantity and delivery schedule agreed by the Parties and send to GSK (or its Affiliates) such revised firm order and a purchase order covering such quantities and delivery date, and GSK (or its Affiliate) shall have the obligation use Commercially Reasonable Efforts to supply such quantity to PAR pursuant to the terms hereof. PAR shall promptly reimburse GSK for any and all documented, reasonable costs and expenses incurred by GSK (or its Affiliate) that arise from any canceled or materially modified firm order (without GSK’s prior written consent) after acceptance thereof by GSK (or its Affiliate), including all obsolete material that can not be reasonably utilized by GSK or its Affiliate. The previous sentence shall not limit GSK’s remedies or damages Cephalon Supplied Products in the event PAR cancels or materially modifies any firm order, and PAR shall not modify or cancel the last firm order in the Supply Termexcess of forecasted amounts. In the event that the Parties reasonably agree that a Third Party Generic Sumatriptan Product is likely to in the immediate future, or has, become available for commercial sale in the Territory, the Parties shall in good faith review and adjust the then-existing Forecast in light FDA Final Approval of the presence of such Third Party Generic Sumatriptan Product in the Territory, provided the Parties shall use their commercially reasonable efforts to mitigate all losses and expenses related to such revisions to the Forecast. The last firm order and Forecast shall be received and agreed by GSK not less than [* * *] ([* * *]) days OVF occurs prior to the Supply Termination Date. The firm orders for the last [* * *] Anticipated Final FDA Approval of OVF previously indicated to ▇▇▇▇ by Cephalon, Cephalon shall supply ▇▇▇▇ with Cephalon Supplied Products no later than thirty ([* * *]) months of the Supply Term shall each not exceed [* * *] percent ([* * *]%) of the average monthly demand for GSK Supplied Product over the prior twelve (12) month period (determined on a sku-by-sku basis), unless PAR can provide reasonable evidence to GSK that there is adequate demand over the remainder of the Supply Term for GSK Supplied Product in excess of such limits. Upon termination or expiration of this Agreement, all firm orders and Forecasts are to be automatically terminated, except to the extent that backordered firm orders remain unfilled. PAR acknowledges and agrees that GSK relies on the [* * *] ([* * *]) month firm zone orders provided by PAR for the purpose of manufacturing planning and ordering necessary materials and components for the production of GSK Supplied Product. In the event PAR does not issue purchase orders in a timely manner (as described in this Section 4.2(c)) covering any [* * *] ([* * *]) month firm zone, PAR agrees that in the event GSK decides in its sole discretion to waive the firm zone requirements set forth herein: (A) GSK is entitled to reasonably rely upon the applicable [* * *] month firm zone last provided by PAR in the Forecast for the purpose of manufacturing planning and ordering necessary materials and components for the production of GSK Supplied Product and (B) in the event GSK is unable to reasonably utilize any such materials and components in the event PAR’s purchase orders are less than as set forth in the firm orders for such [* * *] ([* * *]) month firm zone, PAR shall reimburse GSK for all reasonable out-of-pocket costs incurred by GSK for any such obsolete materials and components, provided GSK uses its reasonable efforts to mitigate the costs associated with such obsolete materials and components. For the avoidance of doubt, GSK shall, in its sole discretion, decide whether or not it (or its Affiliates) will supply PAR with GSK Supplied Product absent purchase orders issued in a timely manner (as described in this Section 4.2(c)) for any [* * *] ([* * *]) month firm zone, however GSK shall reasonably consider supplying PAR in such instance, consistent with GSK’s reasonable ability to do so. (ii) Each purchase order shall specify a delivery date which shall be at least [* * *] ([* * *]30) days after the date following FDA Final Approval of the purchase order. Should a purchase order call for shipment of quantities of GSK Supplied Product in excess of [* * *] percent ([* * *]%) of the immediately preceding estimated requirements previously provided to GSK (or its Affiliate) in the Forecast, GSK (or its Affiliate) will use its Commercially Reasonable Efforts, but shall not be obligated, to supply that portion of excess by the dates instructed by PAR; provided, however, in no event shall GSK (or its Affiliates) have any obligation to forego manufacture of any GSK (or its Affiliates’) products on common equipment that would have a material adverse consequence to GSK business in order to deliver GSK Supplied Product to PAR or its Affiliates in excess of the preceding Forecast. Notwithstanding anything to the contrary, PAR’s first firm orders for the [* * *] ([* * *]) month firm zone for GSK Supplied Product from GSK shall be in the quantities specified in Schedule 4.2(d). GSK (and its Affiliates) shall not be obligated to supply to PAR (or its Affiliates) quantities of GSK Supplied Product in excess of GSK’s (or its Affiliate’s) branded Imitrex® [* * *] product ([* * *]presentations) manufacturing capacity (with such capacity being defined herein as GSK’s [* * *] product ([* * *] presentations) capacity without regard to individual presentation capacity – all subject to PAR’s compliance with the forecasting and firm order requirements in this Agreement). In no event shall such capacity be less than such capacity existing as of the Execution DateOVF. (iii) Delivery of GSK Supplied Product ordered hereunder from GSK (or its Affiliate) to PAR and its Affiliates shall be [***] (Incoterms 2000), whereby [***] and [***] shall bear all risk of loss or damage, and costs of insurance and shipping associated with the GSK Supplied Product [***]. (iv) Attached hereto as Schedule 4.2(d), is PAR’s current good faith non-binding estimate of its (and its Affiliates’) requirements of GSK Supplied Product for the Territory for the [* * *] ([* * *]) months (including the Initial Quantity) following the Launch Date and the remainder of the Forecast. Following the Execution Date, PAR shall provide GSK an updated version of the Forecast on a [* * *] basis. [* * *] ([* * *]) days after the later of (A) [***] and (B) the date GSK notifies PAR of its ability (or inability) to supply PAR with the Generic [* * *] Product in the [* * *], PAR shall provide GSK with a definitive Forecast (in the form applicable to such Launch Date) and binding purchase orders for the [* * *] ([* * *]) months following the Launch Date (such total to include the Initial Quantity) and such Forecast and binding purchase orders shall not vary by more than [* * *] percent ([* * *]%) from the last non-binding Forecast provided to GSK (as determined on a monthly basis) subject to the last sentence of the first paragraph of Section 4.2(c)(i). (v) In ordering and delivering GSK Supplied Product, as the case may be, GSK (or its Affiliates) and PAR may use their respective standard forms and documents in ordering and delivering the GSK Supplied Product, provided that nothing in those forms or documents shall be construed to modify or amend the terms and conditions of this Agreement, and, in the case of any conflict herewith, the terms and conditions of this Agreement shall control.

Appears in 1 contract

Sources: License and Supply Agreement (Cephalon Inc)