Forecasts. (a) The ▇▇▇▇ and Corium advisory committee (Committee) will meet at least [*] prior to the Launch Date of the Product for the purpose of planning a successful Product launch. Corium will prepare a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity and estimated launch date within [*]after receipt of non-binding estimated launch quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Product far enough in advance to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch Plan. (b) After the Launch Date of the Product within the Territory, [*] prior to the beginning of each calendar year, ▇▇▇▇ shall provide to Corium [*] for its requirements of the Product. Such [*] forecast will be updated on a [*] basis, and such update shall be received by Corium no later than [*] prior to the first day of each [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding and shall be used by Corium for planning purposes only. (c) [*] prior to [*], ▇▇▇▇ shall submit to Corium a Firm Order for the Product with a shipment date no sooner than [*] from the date of the Firm Order. Corium shall accept or reject a Firm Order within [*]of its receipt. Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within such [*] period, such Firm Order shall be deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the Product. No change may be made in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld). (d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b), ▇▇▇▇ will pay Corium for the costs of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast within [*] of such Firm Order; provided however that Corium shall use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quarters, and shall reimburse or credit ▇▇▇▇ for costs of all materials so used for a future calendar quarter within [*] after the end of such future calendar quarter.
Appears in 3 contracts
Sources: Development, Manufacturing and Commercialization Agreement (Corium International, Inc.), Development, Manufacturing and Commercialization Agreement (Corium International, Inc.), Development, Manufacturing and Commercialization Agreement (Corium International, Inc.)
Forecasts. Within [* * *] after the Effective Date, Paratek shall submit to CIPAN a forecast of clinical supply of Products that Paratek anticipates ordering from CIPAN during the [* * *] period (abroken down by Product and by month and, if applicable, country in the Territory) The ▇▇▇▇ following the date of such forecast and Corium advisory committee Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (Committeeeach, a “Rolling Clinical Forecast”) will meet at least until Paratek no longer requires any clinical supply of Products. Beginning [* * *] prior to the Launch Date anticipated launch of a Paratek Product in the Territory and for the remainder of the Term, Paratek shall submit to CIPAN a forecast of commercial supply of Products that Paratek anticipates ordering from CIPAN during the [* * *] period (broken down by Product for and by month and, if applicable, country in the purpose Territory) following the date of planning such forecast and Paratek shall update such forecast on a successful Product launch. Corium will prepare rolling [* * *] basis every [* * *] thereafter (each, a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity and estimated launch date “Rolling Commercial Forecast”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *]] after receipt of non-binding estimated launch quantities and launch date from ▇▇▇▇such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority in a country in the Territory. ▇▇▇▇ will Paratek shall place firm purchase orders for at least the quantity of each Product far enough specified in advance to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch Plan.
(b) After the Launch Date of the Product within the Territory, first [* * *] prior to the beginning of each calendar year, ▇▇▇▇ shall provide to Corium [*] for its requirements of the Product. Such [*] forecast will be updated on a [*] basis, and such update shall be received by Corium no later than [*] prior to the first day of each [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding and shall be used by Corium for planning purposes only.
Rolling Clinical Forecast or Rolling Commercial Forecast (c) [*] prior to [*], ▇▇▇▇ shall submit to Corium a Firm Order for the Product with a shipment date no sooner than [*] from the date of the Firm Order. Corium shall accept or reject a Firm Order within [*]of its receipt. Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within such [*] period, such the “Firm Order shall be deemed to be accepted at Forecast Period”) and the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the Product. No change may be made in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld).
(d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b), ▇▇▇▇ will pay Corium for the costs of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast within remaining [* * *] of such Firm Order; provided however that Corium forecast shall use commercially reasonable effort be a good faith estimate. Except as set forth in the immediately preceding sentence, Paratek shall not be required to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quartersorder any fixed minimum quantity of either Product, and shall reimburse notwithstanding any forecast or credit ▇▇▇▇ for costs prior course of all materials so used for a future calendar quarter within [*] after the end of such future calendar quarterdealing.
Appears in 3 contracts
Sources: Manufacturing Agreement (Paratek Pharmaceuticals, Inc.), Manufacturing and Services Agreement (Paratek Pharmaceuticals, Inc.), Manufacturing and Services Agreement (Paratek Pharmaceuticals, Inc.)
Forecasts. In order to assist Miltenyi with its capacity, procurement and production planning, Autolus agrees to provide Miltenyi with rolling forecasts of Autolus’ (and its Affiliates’, Subcontractors’, and Licensees’) anticipated requirements for Miltenyi Products during the Term of this Agreement, in accordance with the provisions of this Section 5.1 (each, a “Forecast”). All of the Forecasts provided under this Agreement shall break down the demand of Miltenyi Products on a product-by-product (expressed in number of units or lots) and country-by-country basis. All Forecasts provided by Autolus shall be good faith estimates of Autolus’ anticipated requirements for Miltenyi Products during the relevant period. Autolus agrees to use Commercially Reasonable Efforts in preparing all Forecasts provided hereunder to minimize variances between Forecasts. Each Forecast shall be duly signed by an authorized representative of Autolus (or Autolus’ designee on behalf of Autolus) and submitted in writing to Miltenyi, by mail or facsimile, and shall supersede prior Forecasts to the extent the Forecast overlaps with prior Forecasts. Each initial Forecast to be provided by Autolus under clauses (a) The ▇▇▇▇ through (c) below shall be subject to Miltenyi’s written consent, which shall not be unreasonably withheld, and Corium advisory committee (Committee) which it will meet at least [*] prior endeavor to the Launch Date of the Product for the purpose of planning a successful Product launch. Corium will prepare a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity and estimated launch date provide within [*]after **] Business Days of receipt of non-binding estimated launch quantities the initial Forecasts from Autolus.
(a) Rolling [***] Forecast; Firm Zone. Within [***] Business Days of the Effective Date, and launch date from ▇▇▇▇thereafter by the [***] Business Day of each [***] during the Term, Autolus (or Autolus’ designee on behalf of Autolus) shall submit a [***] rolling Forecast of Autolus’ anticipated demand of Miltenyi Products for each of the next [***] consecutive Calendar [***], commencing with the Calendar [***] in which such Forecast is submitted (each, a “[***] Forecast”). ▇▇▇▇ will place firm purchase orders The [***] Forecast shall show demand on a [***] basis, and for the Product far enough [***] months shall state the desired dates of Delivery for the forecasted quantities. With respect to any [***] Forecast for Miltenyi Products submitted during the Term, [***] of the quantities forecasted for the [***] period of each [***] Forecast (each such [***] period shall be referred to as the “Firm Zone”) shall be binding, and the corresponding portion of each subsequent [***] Forecast shall be consistent with such period. For clarity, all forecasted demands of Miltenyi Products during the Firm Zone shall constitute a binding commitment by Autolus to submit corresponding Purchase Orders for Miltenyi Products. The Parties agree that except with respect to the Firm Zone and the limitations in advance to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch PlanSection 5.1(d) hereof, a [***] Forecast provided by Autolus shall not be binding upon Autolus.
(b) After the Launch Date Rolling [***] Forecast. Within [***] Business Days of the Product within Effective Date, and thereafter by the Territory, [***] prior to the beginning Business Day of each calendar year, ▇▇▇▇ shall provide to Corium Calendar [***] during the Term, Autolus (or Autolus’ designee on behalf of Autolus) shall submit a non-binding [***] rolling Forecast of Autolus’ anticipated demand of Miltenyi Products for its requirements each of the Product. Such [***] forecast will be updated Calendar [***] immediately following the last Calendar [***] of the [***] Forecast submitted pursuant to clause (a) above (each, a “[***] Forecast”). Each [***] Forecast shall show demand on a [***] basis, and such update shall be received by Corium no later than [*] prior to the first day of each [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding and shall be used by Corium for planning purposes only.
(c) [*] prior to [*], ▇▇▇▇ shall submit to Corium a Firm Order for the Product with a shipment date no sooner than [*] from the date of the Firm Order. Corium shall accept or reject a Firm Order within [*]of its receipt. Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within such [*] period, such Firm Order shall be deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the Product. No change may be made in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld).
(d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b), ▇▇▇▇ will pay Corium for the costs of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast within [*] of such Firm Order; provided however that Corium shall use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quarters, and shall reimburse or credit ▇▇▇▇ for costs of all materials so used for a future calendar quarter within [*] after the end of such future calendar quarter.
Appears in 3 contracts
Sources: Supply Agreement (Autolus Therapeutics LTD), Supply Agreement (Autolus Therapeutics LTD), Supply Agreement (Autolus Therapeutics LTD)
Forecasts. (a) The ▇▇▇▇ and Corium advisory committee (Committee) will meet at least Commencing on the Effective Date, OptiNose shall provide CPL each month with non-binding, rolling [***] ([***]) month forecast of its Product requirements (“Rolling Forecast”). OptiNose shall be obligated to purchase the unit quantity of Products for the first [***] months of any Rolling Forecast that was requested in the Rolling Forecast for that [***] ([***]) month period (a “Binding Period”). During the [***] of each calendar month OptiNose will issue a new Rolling Forecast which shall be updated monthly by OptiNose no later than the [***] ([***]) business day of each calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] month of the going forward [***] month Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not be required to place any Purchase Order for quantities that otherwise would be applicable for any Binding Period, and OptiNose may, in its sole discretion, cancel or modify any Purchase Order placed prior to the Launch Date of the Product for the purpose of planning a successful Product launch. Corium will prepare a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity and estimated launch date within Final Approval Date; [*]after receipt of non-binding estimated launch quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Product far enough in advance to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch Plan.
(b) After the Launch Date of the Product within the Territory, [*] prior to the beginning of each calendar year, ▇▇▇▇ shall provide to Corium [*] for its requirements of the Product. Such [*] forecast will be updated on a [*] basis, and such update shall be received by Corium no later than [*] prior to the first day of each [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding and shall be used by Corium for The Parties will work collaboratively together regarding planning purposes only.
(c) [*] prior of production of initial Product required to [*], ▇▇▇▇ shall submit to Corium a Firm Order for the build initial launch quantities of Product with a shipment date no sooner than [*] from the date in anticipation of the Firm OrderFinal Approval Date. Corium During the term of this Agreement, CPL shall accept or reject ensure that, subject to utilization of OptiNose Equipment, it has the Capacity to meet all of OptiNose’s requirements for Product in a Firm Order within [*]of its receipt. Corium may reject a Firm Order if at timely manner based on the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable applicable Rolling Forecast under this Agreement and subject to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within such [*] period, such Firm Order shall be deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the Product. No change may be made in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld).
(d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter ’s standard lead time pursuant to Section 8.4(b), ▇▇▇▇ 2.5; provided that if new or additional OptiNose Equipment is required CPL will pay Corium for the costs of any unused quantities of such materials ordered inform OptiNose with sufficient lead time for such calendar quarter in reliance on such forecast within [*] of such Firm Order; provided however that Corium shall OptiNose Equipment to be acquired and qualified for use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quarters, and shall reimburse or credit ▇▇▇▇ for costs of all materials so used for a future calendar quarter within [*] after the end of such future calendar quarterthis Agreement.
Appears in 3 contracts
Sources: Manufacture and Supply Agreement, Manufacture and Supply Agreement (OptiNose, Inc.), Manufacture and Supply Agreement (OptiNose, Inc.)
Forecasts. (ai) The ▇▇▇▇ and Corium advisory committee (Committee) will meet at least On [****] prior to the Launch Date of the Product for the purpose of planning a successful Product launch. Corium will prepare a Production Launch Plan for the Product based and on ▇▇▇▇’▇ estimated launch quantity and estimated launch date within or about each [*]after receipt of non-binding estimated launch quantities ***] and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Product far enough in advance to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch Plan.
(b) After the Launch Date of the Product within the Territory, [****] prior to between the beginning of each calendar year[****] and [****], ▇▇▇▇ Customer shall provide to Corium Supplier (by email to the attention of Supplier’s Sales Administrator and Director of Manufacturing, with a copy to Business Leader, Sequencing) 12-month forecasts (by month) of its requirements for each of the Products in the format reasonably requested by Supplier (the “Forecasts”). Supplier shall provide the recipient email addresses from time to time (by email to the attention of Customer’s VP of Operations with a copy to Director of Purchasing) and Customer acknowledges that such new email addresses shall be effective upon receipt from Supplier regardless of Section 11.a. The initial Forecast is set forth in Exhibit F attached hereto (the “Initial Forecast”) and shall be deemed to be the [*] for its requirements of the Product. Such [***] forecast will be updated on a for purposes of [*] basis, and such update shall be received by Corium no later than [*] prior to the first day of each [**]. Except as otherwise The first six (6) months of each such Forecast provided herein, these requirements forecasts in [****] shall constitute a binding obligation to purchase the specified Products (the “Binding Forecast”) to the extent that the specified Product being ordered is within production lead times. The second six (6) months of each such Binding Forecast shall be non-binding (the “Non-Binding Forecast”). The Forecasts provided in [****] are for discussion purposes only and will not amend the then-current Binding Forecast. Each Binding Forecast will be accompanied by a purchase order (a “Purchase Order”) describing the terms, dates and delivery schedule for such purchases. Supplier shall accept each Purchase Order that complies with a Binding Forecast and the other terms of this Agreement. Supplier will use commercially reasonable efforts to supply Products ordered by Customer that are in addition to those required by the then-current Binding Forecast. For clarity, the then-current Binding Forecast shall lock in prices for the period of such Binding Forecast such that any additional Consumables ordered by Customer and supplied by Supplier during the period of such Binding Forecast shall be used ordered and sold at the relevant price indicated by Corium for planning purposes onlysuch Binding Forecast in accordance with this Agreement. CONFIDENTIAL TREATMENT REQUESTED UNDER C.F.R. SECTIONS 200.80(b)(4), 200.83 AND 230.406. [****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION.
(cii) Beginning on [****] prior to and on or about each subsequent [*]***] and [****] during the Term of this Agreement, ▇▇▇▇ Customer shall submit provide to Corium a Firm Order for Supplier (by email to the Product attention of Supplier’s Sales Administrator and Director of Manufacturing, with a shipment date no sooner than [*] from the date copy to Business Leader, Sequencing) 12-month forecasts (by month) of its requirements for each of the Firm Order. Corium shall accept or reject a Firm Order within [*]of its receipt. Corium may reject a Firm Order if at Products in the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within format reasonably requested by Supplier and each such [*] period, such Firm Order shall be deemed to be accepted at the end of such period. Except as provided herein, the Firm Order forecast shall constitute a binding agreement by ▇▇▇▇ obligation to purchase the Productspecified amount and type of Products (the “Binding Forecast”) to the extent that the specified Product being ordered is within production lead times. No change may For clarity, the Binding Forecast provided on or about the A&R Effective Date shall be made for the period beginning [****] and [****] (inclusive), the Binding Forecast provided on or about [****] shall be for the period beginning [****] and [****] (inclusive), and subsequent Binding Forecasts shall follow in like manner. Supplier shall provide the binding recipient email addresses from time to time (by email to the attention of Customer’s VP of Operations with a copy to Director of Purchasing) and Customer acknowledges that such new email addresses shall be effective upon Customer’s confirmation of receipt from Supplier regardless of Section 11.a. Each Binding Forecast required by this Section 2.a(ii) will be accompanied by a purchase order (a “Purchase Order”) for Product or any Products required for the shipment dates requested therefor without the prior consent first six (6) months of Corium (such consent not Binding Forecast, including any Instruments required to be unreasonably withheldpurchased by Customer during such six (6) month period in accordance with Section 1.a(iv).
(d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast . The Purchase Orders shall describe the terms, dates and delivery schedule for such calendar quarter pursuant to Section 8.4(b), ▇▇▇▇ will pay Corium for purchases in accordance with the costs terms of any unused quantities this Agreement. Supplier shall accept each Purchase Order that complies with a Binding Forecast and the other terms of such materials ordered for such calendar quarter in reliance on such forecast within this Agreement. [*] of such Firm Order; provided however that Corium shall use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quarters, and shall reimburse or credit ▇▇▇▇ for costs of all materials so used for a future calendar quarter within [*] after the end of such future calendar quarter**].
Appears in 2 contracts
Sources: Supply Agreement (Raindance Technologies Inc), Supply Agreement (Raindance Technologies Inc)
Forecasts. (a) The ▇▇▇▇ and Corium advisory committee (Committee) will meet at least [*] prior During the term of this Agreement, Buyer shall use its best efforts to the Launch Date of the Product update, on a quarterly basis, a continuous usage forecast to assist Seller in maintaining an orderly production flow for the purpose of planning meeting Buyer's delivery requirements. Buyer's failure to provide such information may be considered cause by Seller for excusable delivery delay.
3. CANCELLATION Buyer may cancel orders placed in accordance with the terms and conditions of this Agreement upon payment of cancellation charges which shall include all costs incurred or committed for, and a successful Product launch. Corium will prepare reasonable profit on such costs, unless (i) such costs are otherwise recoverable through the sale of the product on a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity and estimated launch date within [*]after receipt of non-binding estimated launch quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Product far enough in advance timely basis or (ii) Buyer's cancellation is due to Motorola's failure to meet ▇▇▇▇’▇ launch its forecasted delivery schedule resulting in cancellation of Product orders by Buyer's own customer. Payment of cancellation charges shall be due within thirty (30) days of the date of invoice. Seller agrees to divert completed material and work in process from canceled orders to other requirements based on Corium’s Production Launch Planwherever possible in order to minimize cancellation charges.
4. DELIVERY AND PAYMENT
(a) All deliveries are FOB Motorola's plant. Each such delivery will be separately invoiced and payment from Buyer shall be due thirty (30) days from the date thereof without regard to other deliveries. DELIVERY DATES ARE BEST ESTIMATES ONLY.
(b) After Title to the Launch Date Products sold shall pass to Buyer at the FOB point. Buyer hereby grants to MOTOROLA a security interest and lien upon all of Buyer's now existing or hereafter acquired inventory of the Product within products, and all of Buyer's account, chattel paper, instruments, contract rights, general intangibles, accounts receivable and the Territoryproceeds thereof now existing or hereafter arising out of Buyer's sale or other disposition of the products. Buyer agrees to cooperate in whatever manner necessary to assist MOTOROLA in perfecting and recording such security interest and lien upon request.
5. FORCE MAJEURE MOTOROLA shall not be liable for any delay or failure to perform due to any cause beyond its reasonable control. Causes include but are not limited to strikes, [*] prior acts of God, acts of the Buyer, interruptions of transportation or inability to obtain necessary labor, materials or facilities, or default of any supplier, or delays in FCC frequency authorization or license grant. The delivery schedule shall be considered extended by a period of time equal to the beginning time lost because of each calendar year, ▇▇▇▇ shall provide to Corium [*] for its requirements of any excusable delay. To the Product. Such [*] forecast will be updated on a [*] basis, and such update shall be received by Corium no later than [*] prior to the first day of each [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding and shall be used by Corium for planning purposes only.
(c) [*] prior to [*], ▇▇▇▇ shall submit to Corium a Firm Order for the Product with a shipment date no sooner than [*] from the date of the Firm Order. Corium shall accept or reject a Firm Order within [*]of its receipt. Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium extent that MOTOROLA is unable to fill manufacture and deliver the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within such [*] periodannual commitment, such Firm Order it shall be deemed reduced on a pro rata basis. In the event MOTOROLA is unable to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the Product. No change may be made in the binding purchase order for Product wholly or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld).
(d) Should ▇▇▇▇’▇ Firm Order partially perform for a calendar quarter be less period greater than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b), ▇▇▇▇ will pay Corium for the costs forty-five (45) days because of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast within [*] of such Firm Order; provided however that Corium shall use commercially cause beyond its reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quarterscontrol, and shall reimburse or credit ▇▇▇▇ for costs of all materials so used for a future calendar quarter within [*] after the end of such future calendar quartereither party may terminate any delayed order without any liability.
Appears in 2 contracts
Sources: Sales Contracts (Transcrypt International Inc), Sales Contracts (Transcrypt International Inc)
Forecasts. (a) The ▇▇▇▇ and Corium advisory committee (Committee) will meet at least [*ORPHAN shall provide Catalytica with forecasts of ORPHAN’S anticipated [ * ] prior to the Launch Date requirements of the Product for distribution and sale in the purpose United States commencing with the [ * ] period that begins at the time of planning a successful Product launchFDA approval of the Product. Corium Such forecast will prepare a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity and estimated launch date within [*]after receipt of non-binding estimated launch quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Product far enough be provided [ * ] in advance to meet ▇▇▇▇’▇ launch requirements based of anticipated FDA approval of the NDA and ORPHAN shall update such [ * ] forecast on Corium’s Production Launch Plan.
(b) After the Launch Date [ * ] basis thereafter. Once FDA approval of the Product within the Territoryis received, [*] ORPHAN will provide Catalytica, prior to the beginning of each calendar year[ * ], ▇▇▇▇ shall provide to Corium [*] for with forecasts of its anticipated requirements of the ProductProduct for the following [ * ] and the forecast for the first [ * ] shall be firm and binding on ORPHAN. Such [*Catalytica will provide [ * ] anticipated schedule for manufacture and will consult with ORPHAN on schedule changes.
(a) Catalytica shall [ * ] manufacture during any [ * ] up to [ * ] of the quantity of the Product ORPHAN forecasted it would purchase from Catalytica during such [ * ] in its most recent forecast covering [ * ]. Catalytica will promptly communicate with ORPHAN as to its ability to produce quantities requested.
(b) When and as ORPHAN proposes to commence its distribution and sale of the Product outside the United States, ORPHAN shall supplement its [ * ] forecast will be updated on a [*accordingly to indicate the additional requirements of the Product for such purposes. [ * ] basis= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, and such update shall be received by Corium no later than [*] prior to the first day of each [*]. Except as otherwise provided hereinMARKED BY BRACKETS, these requirements forecasts shall be non-binding and shall be used by Corium for planning purposes onlyHAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
(c) [*] prior to [*], ▇▇▇▇ shall submit to Corium a Firm Order for If Catalytica manufactures the Product with a shipment date no lead time of more than [ * ], ORPHAN shall not be required to pay any additional storage, or pay for the Product sooner than [*] from the date as set forth in Section 7.7 nor shall any advance manufacture lead to a violation of the Firm Order. Corium shall accept or reject a Firm Order within [*]warranty of its receipt. Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is expiration date set forth in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within such [*] period, such Firm Order shall be deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the Product. No change may be made in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld)Section 8.1.
(d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b), ▇▇▇▇ will pay Corium for the costs of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast within [*] of such Firm Order; provided however that Corium shall use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quarters, and shall reimburse or credit ▇▇▇▇ for costs of all materials so used for a future calendar quarter within [*] after the end of such future calendar quarter.
Appears in 1 contract
Forecasts. (a) The ▇▇▇▇ and Corium advisory committee (Committee) will meet at least [*] prior to During the Launch Date term of the Product for the purpose of planning a successful Product launch. Corium will prepare a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity and estimated launch date within [*]after receipt of non-binding estimated launch quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Product far enough in advance to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch Plan.
(b) After the Launch Date of the Product within the Territorythis Agreement, [*] prior to the beginning of each calendar year, ▇▇▇▇ PCYC shall provide to Corium [DOTTIKON [ *** ] for its requirements a written rolling forecast of the Productquantities of such Product it intends in good faith to purchase under this Agreement during [ *** ] For example, the forecast provided at [ *** ] will cover the quantities of Products to be delivered during [ *** ] Each such forecast shall have the following effect, except as otherwise set forth in the applicable Product Appendix: [ *** ] [ *** ]; and [ *** ]; and [ *** ] Purchase Orders. Such [*] forecast will be updated on a [*] basis, and such update All purchases of Products shall be received by Corium no later than [*] prior made pursuant to Purchase Orders which shall be delivered to the first day Facility, or such other location as agreed to in writing by the Parties, at least [ *** ] in advance of each [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding and shall be used by Corium for planning purposes only.
(c) [*] prior to [*], ▇▇▇▇ shall submit to Corium a Firm Order for the Product with a shipment date no sooner than [*] from the date of shipment specified in such Purchase Order, or to such other location and/or within such other time period as may be specified in the Firm applicable Product Appendix. DOTTIKON shall ship all Products as set forth in Section 4.5 by the date and in the quantities specified in the applicable Purchase Order. Corium PCYC shall be obligated to buy and DOTTIKON shall be obligated to sell only the quantities of Product which are subject to a Purchase Order accepted by DOTTIKON; [ *** ] as may be described in the applicable Product Appendix. DOTTIKON shall be obligated to accept any Purchase Order that does not require DOTTIKON to Manufacture a Product in quantities in excess of DOTTIKON's Capacity for such Product, and shall use its best efforts to accept any Purchase Order in excess thereof. Any Purchase Order (or reject portion thereof) for which PCYC has not received a Firm written rejection from DOTTIKON within [ *** ] of DOTTIKON's receipt of such Purchase Order within [shall automatically be deemed accepted by DOTTIKON. Within [ *]** ] following its acceptance of a Purchase Order, DOTTIKON shall provide to PCYC a written schedule of its receiptintended Manufacturing campaign for fulfilling such Purchase Order. Corium may reject a Firm Order if at To the time of its receipt ▇▇▇▇ is in default extent that the terms of a payment or other obligation or if Corium is unable to fill Purchase Order are inconsistent with the Firm Order within the time specifiedterms of this Agreement, this Agreement shall control. If Corium fails to accept or reject a Firm Order within such [*] period, such Firm No Purchase Order shall be deemed to amend, modify or supplement this Agreement or any Product Appendix. Purchase Orders and the acceptance or rejection thereof shall be accepted at submitted by facsimile to the end attention of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the Product. No change may be made contact person or department specified in the binding purchase order for applicable Product or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld).
(d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b), ▇▇▇▇ will pay Corium for the costs of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast within [*] of such Firm Order; provided however that Corium shall use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quartersAppendix, and shall reimburse or credit ▇▇▇▇ for costs of all materials so used for a future calendar quarter within [*] after confirmed by mail, unless otherwise agreed in the end of such future calendar quarterapplicable Product Appendix.
Appears in 1 contract
Sources: Supply Agreement (Pharmacyclics Inc)
Forecasts. (a) The Prior to the execution of this Agreement, EyePoint shared with ▇▇▇▇▇▇▇ and Corium advisory committee (Committee) will meet at its 2023 demand forecast for the Product for the U.S. market. At least [***] prior to the Launch Date commencement of each Agreement Year during the Product for Term after the purpose of planning a successful Product launch. Corium will prepare a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity first Agreement Year, EyePoint and estimated launch date within Alimera shall discuss [*]after receipt of **] a non-binding estimated launch plan of Product supply quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders timelines for the Product far enough in advance to meet ▇▇▇▇’▇ launch requirements upcoming Agreement Year based on Corium’s Production Launch [***] (the “Agreement Year Plan”).
(b) After the Launch Date of the Product within the Territory, At least [***][***] prior to the beginning of each calendar yearCalendar Quarter occurring during the Term, Alimera shall deliver to EyePoint a proposed [***] rolling forecast of the quantities of the Product that Alimera expects to order [***] (the “Rolling Forecast”). The Parties shall [***][***] review each Rolling Forecast proposed by ▇▇▇▇▇▇▇ shall provide to Corium [*] for its requirements and discuss any limitations on the quantities of the Product. Such [*] forecast will be updated on a [*] basis, and such update shall be received by Corium no later than [*] prior to the first day of each [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding and shall be used by Corium for planning purposes only.
(c) [*] prior to [*], ▇▇▇▇ shall submit to Corium a Firm Order for the Product with a shipment date no sooner than [*] from the date of the Firm Order. Corium shall accept or reject a Firm Order within [*]of its receipt. Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within such [*] period, such Firm Order shall be deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement requested by ▇▇▇▇ to purchase the Product. No change may be made in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld).
(d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b), ▇▇▇▇ will pay Corium for the costs of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast within [*] of such Firm Order; provided however that Corium shall use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quarters, and shall reimburse or credit ▇▇▇▇ for costs [***] of all materials so used the Rolling Forecast based on capacity and other relevant factors. The Parties shall [***] agree on the Rolling Forecast for a future calendar quarter [***] within [***] after EyePoint’s receipt thereof. EyePoint will automatically be deemed to have accepted such portion of the end Rolling Forecast if it has not sent written notice to Alimera of its rejection of such future calendar quarterportion within [***] after EyePoint receives the Rolling Forecast. Such written notice must include [***] its reason for rejecting such portion of the Rolling Forecast and the amounts that it can accept for such period. If EyePoint provides such written notice to ▇▇▇▇▇▇▇, then the Parties shall [***] agree on [***] of the Rolling Forecast within [***] after ▇▇▇▇▇▇▇’s receipt thereof, and if the Parties are not able to agree on such portion of the Rolling Forecast during such period, then 5 EyePoint’s counterproposal in its written notice will automatically be deemed accepted by ▇▇▇▇▇▇▇. The [***]of each Rolling Forecast [***] shall be binding upon the Parties and referred to herein as the “Firm Order”. EyePoint may decline to approve and adjust any portion of the [***] of each Rolling Forecast by providing written notice to Alimera within [***] of receipt thereof; provided, that (i) EyePoint shall approve the [***]s of each Rolling Forecast that is within [***] percent ([***]%) of the quantity requirements for the same period in the immediately preceding Rolling Forecast to the extent previously approved by EyePoint, and (ii) not otherwise act unreasonably in declining to approve and adjusting any such Rolling Forecast. Once approved, the Firm Order may only be changed by [***]. If EyePoint fails to provide its written notice to adjust during such [***] period, then such portion of such Rolling Forecast will automatically be deemed accepted by EyePoint. Attached hereto as Exhibit B is the initial Rolling Forecast, the Firm Order of which is based on [***] demand forecast for the Product for the U.S. market.
Appears in 1 contract
Forecasts. 4.1 The BUYER agrees to purchase and the COMPANY agrees to sell the PRODUCTS in the quantities and at the prices set forth in Exhibit C attached hereto and made an integral part hereof.
4.2 The COMPANY will promptly effect shipment of the PRODUCTS after the manufacture thereof shall have been completed in each month of production as agreed. Delivery terms shall be on the basis of FOB Japan (a) or country of manufacture).
4.3 The ▇▇▇▇ and Corium advisory committee (Committee) will meet at least BUYER's good faith forecast for its expected purchases of PRODUCTS for the twelve month period beginning from April 1, 2000 is [*] prior to the Launch Date of the Product for the purpose of planning a successful Product launch. Corium will prepare a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity and estimated launch date within [*]after receipt of non-binding estimated launch quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Product far enough in advance to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch Plan.
(b) After the Launch Date of the Product within the Territory, Beginning [*] prior after the first delivery order, the BUYER shall then deliver to the beginning of each calendar year, ▇▇▇▇ shall provide to Corium [*] for its requirements of * CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. the Product. Such COMPANY a revised forecast at least once per [*] forecast will be updated on a rolling [*] basis, and such update shall be received by Corium no later than [*] prior to .
4.4 Forecasts provided under the first day of each [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding and shall be used by Corium paragraph (4.3) above are for planning purposes only.
(c) [*] prior only and do not constitute an order commitment or obligation on the part of the BUYER or the COMPANY. To the extent reasonably possible, however, the BUYER agrees to [*], ▇▇▇▇ place orders consistent with such forecasts. The volume ordered by the BUYER in any given month may be increased or decreased from the volume included in the forecast and there shall submit to Corium a Firm Order be no fee associated with such variance. If the BUYER submits any forecast or places any order in which the quantity of PRODUCTS forecasted or ordered for the Product with a shipment date no sooner any month deviates by more than [*] from the date forecasted quantity of the Firm Order. Corium shall accept or reject a Firm Order within [*]of its receipt. Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within PRODUCTS for such [*] periodcontained in the most recent prior forecast submitted to the COMPANY, then the parties shall negotiate in good faith to determine a mutually agreeable delivery schedule, taking into account BUYER's delivery requirements and the required lead time for any modifications to the COMPANY's procurement, manufacturing and testing processes.
4.5 In addition to the formal procedures set forth above, the parties agree that they will promptly inform each other of any material change in their expectations or capabilities relating to the manufacturing, ordering or delivery of PRODUCTS hereunder, such Firm Order shall be deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the Product. No change may be made altered requirements and difficulties in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld)productions.
(d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b), ▇▇▇▇ will pay Corium for the costs of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast within [*] of such Firm Order; provided however that Corium shall use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quarters, and shall reimburse or credit ▇▇▇▇ for costs of all materials so used for a future calendar quarter within [*] after the end of such future calendar quarter.
Appears in 1 contract
Sources: Sales Agreement (Utstarcom Inc)
Forecasts. Distributor agrees to provide ▇▇▇▇▇▇▇▇ with a three (3) month forecast indicating Distributor's intended purchases of Products during each calendar quarter of the term of this Agreement.
(a) The ▇▇▇▇▇▇▇▇ acknowledges that Distributor will order Products to meet specific contractual commitments to Distributor's dealers and their customers for delivery by specified dates, and that the consequences of late delivery may be significant. Accordingly, if ABioNova anticipates any delays or interruptions in the delivery of the Products which are estimated to extend for more than ten (I 0) days past the delivery date stated for the Products in a purchase order which has been accepted by ABioNova (an "Agreed Delivery Date"), ABioNova shall notify Distributor of the estimated date on which delivery will be made, and shall cooperate with Distributor in rescheduling deliveries to minimize the effect of such delays and interruptions on Distributor. If Distributor notifies ▇▇▇▇▇▇▇▇ in writing in the order and acceptance process for a Product purchase that late delivery penalties or other amounts will be payable to a customer if delivery of the Products is delayed past an Agreed Delivery Date, and ABioNova causes such a delay to occur, ABioNova shall reimburse Distributor for the full amount of such penalties and other amounts. ABioNova's payment of such penalties and other amounts shall be Distributor's sole and exclusive remedy in the event that delivery of the Products is delayed beyond the Agreed Delivery Date, and ABioNova shall have no further responsibility or liability to Distributor in connection therewith.
(b) Notwithstanding the provisions of Subsection 5.7(a) hereof:
(i) In the event that ▇▇▇▇▇▇▇▇ and Corium advisory committee (Committee) will meet at least [*] prior Distributor agree to a change in a purchase order after such purchase order has been accepted by ABioNova, the Launch Agreed Delivery Date shall be of the Product for the purpose of planning no force and effect, and a successful Product launch. Corium will prepare a Production Launch Plan for the Product based on new Agreed Delivery Date shall be agreed upon by Distributor and ▇▇▇▇’▇ estimated launch quantity and estimated launch date within [*]after receipt of non-binding estimated launch quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Product far enough in advance to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch Plan.
(bii) After In the Launch Date event that Distributor fails to pay to ABioNova an amount equal to forty percent (40%) of the Product within the Territory, [*] prior to the beginning of each calendar year, ▇▇▇▇ shall provide to Corium [*] for its requirements price of the Product. Such [*] forecast will Products within five (5) business days of ABioNova's acceptance of the purchase order to which such Products relate, as described in Subsection 7.3(a)(i) hereof, the Agreed Delivery Date shall be updated on a [*] basisof no force or effect, and such update a new Agreed Delivery Date shall be received agreed upon by Corium no later than [*] prior ABioNova and Distributor at such time as Distributor pays an amount equal to forty percent (40%) of the first day price of each [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding and shall be used by Corium for planning purposes onlysuch Products to ABioNova.
(ciii) [*] prior In the case of an event of Force Majeure which prevents ABioNova from delivering Products to [*]Distributor on an Agreed Delivery Date, ▇▇▇▇ ABioNova shall submit not be liable to Corium a Firm Order Distributor for its failure to deliver Products on the Product with a shipment date no sooner than [*] from Agreed Delivery Date, and the date provisions of the Firm Order. Corium shall accept or reject a Firm Order within [*]of its receipt. Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within such [*] period, such Firm Order Section 5.7(a) shall be deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the Product. No change may be made in the binding purchase order for Product no force or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld)effect.
(d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b), ▇▇▇▇ will pay Corium for the costs of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast within [*] of such Firm Order; provided however that Corium shall use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quarters, and shall reimburse or credit ▇▇▇▇ for costs of all materials so used for a future calendar quarter within [*] after the end of such future calendar quarter.
Appears in 1 contract
Sources: Distributorship Agreement
Forecasts. (a) The ▇▇▇▇ a. As soon as practicable after the Effective Date and Corium advisory committee (Committee) will meet at least [*] days prior to the Launch Date of the Product for the purpose of planning a successful Product launch. Corium will prepare a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity and estimated launch date within [*]after receipt of non-binding estimated launch quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Product far enough in advance to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch Plan.
(b) After the Launch Date of the Product within the Territory, [*] prior to the beginning of each calendar yearmonth thereafter, ▇▇▇▇ shall Amgen will provide to Corium [*] Insulet with eighteen (18) month rolling * Confidential treatment has been requested for its requirements portions of this exhibit. The copy filed herewith omits the Product. Such [*] forecast will be updated on a [*] basis, and such update shall be received by Corium no later than [*] prior information subject to the first day of each confidentiality request. Omissions are designated as [*]. Except as otherwise provided hereinA complete version of this exhibit has been filed separately with the Securities and Exchange Commission. forecasts of Amgen’s anticipated monthly requirements for Custom Insulet Devices (each, these requirements forecasts a “Forecast”), which Forecasts shall be non-binding and shall be used by Corium for planning purposes only.
(c) commence on the month immediately following delivery of such forecast. The [*] prior to [*]of each such Forecast shall be binding on Amgen (the “Binding Portion”) and Amgen shall issue Purchase Orders for all amounts included in the Binding Portion of such Forecasts.
b. Except as mutually agreed in writing by the Parties, ▇▇▇▇ shall submit to Corium a Firm Order for each Forecast following the initial Forecast provided by Amgen, the quantity of Customized Insulet Device forecast (i) for the Product with a shipment date no sooner than [*] months of such Forecast shall not vary from the date of the Firm Order. Corium shall accept or reject a Firm Order within [*]of its receipt. Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within amounts forecasted for such [*] period, such Firm Order shall be deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the Product. No change may be made months in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld).
(d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b)previously delivered Forecast, ▇▇▇▇ will pay Corium (ii) the amounts forecasted for the costs of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast within [*] of such Firm Order; provided however that Corium Forecast shall use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quarters, and shall reimburse or credit ▇▇▇▇ for costs of all materials so used for a future calendar quarter within not exceed [*] after percent ([*]%) of the end amounts forecasted for such month in the most recent previously delivered Forecast and (iii) the amounts forecasted for the [*] months of such future calendar quarterForecast shall not exceed [*] percent ([*]%) of the amounts forecasted for such months in the most recent previously delivered Forecast. Accompanying each Forecast, Amgen shall place a binding Purchase Order in accordance with Section 2.7 for Custom Insulet Devices for the first month contained in such Forecast.
c. Each Party acknowledges and agrees that, except with respect to the Binding Portion of each Forecast, as may be adjusted pursuant to Section 2.6(b), (a) the Forecasts are for planning purposes only, (b) Amgen will prepare such Forecasts in good-faith, but does not guarantee the accuracy of any portions of such Forecasts, and (c) with the exception of the Binding Portion of the Forecasts, Insulet does not guarantee its ability to meet the requirements of such Forecasts.
Appears in 1 contract
Sources: Supply Agreement (Insulet Corp)
Forecasts. (a) The ▇▇▇▇ and Corium advisory committee (Committee) will meet at least [*] prior Prior to the Launch Date first commercial launch of the Product using Corden as a registered commercial Manufacturer (“Launch”), the Parties shall agree on a binding reservation schedule for the purpose manufacturing capacity required for commercial manufacturing of planning a successful Product launchProduct. Corium will prepare a Production Launch Plan This reservation schedule as well as the milestones for services for the validation batches may only be changed by mutual agreement of the Parties, ,as further detailed in the Product based Addendum.
(b) Unless otherwise agreed in a Product Addendum, during the Term, but no later than the Quarter in which the Product is launched in the first market of the Territory, on a [***] basis, Customer shall provide Corden with a rolling [***]-month forecast (“Rolling Forecast”) indicating Customer’ expected delivery of Product for the next [***] (i.e., [***]), in full batch sizes. The first [***] months (i.e., the first [***] ) of the Rolling Forecast (i.e., [***]) shall be considered binding for both Parties under this Section 5 (“Binding Forecast”), and the second [***] period (i.e., [***]) shall be considered non-binding for both Parties (“Non-Binding Forecast”). The initial Rolling Forecast is attached hereto as Schedule 1, and each subsequent update will be due on or before the [***] Business Day of each new [***] during the Term (covering such new [***] and the subsequent [***] ).
(c) Corden shall review each update to the Rolling Forecast and assess if it is able to manufacture or otherwise supply Customer’ requirements for Product in excess of the amount set forth in the previous Binding Forecast, if any, and assuming that the remainder of the Rolling Forecast will become binding in time as contemplated by this Agreement. In the event that, upon receipt of an updated Rolling Forecast, Corden anticipates that it shall not be able to manufacture or otherwise supply Customer’ requirements for Product in excess of the amount set forth in the previous Binding Forecast, Corden shall inform Customer in writing within [***] Business Days after ▇▇▇▇’▇ estimated launch quantity and estimated launch date within [*]after ▇▇’s receipt of non-binding estimated launch quantities said updated Rolling Forecast, and launch date Customer shall then be entitled to obtain from alternative suppliers any such excess amount of Product which Corden has indicated that it would not be able to manufacture or otherwise supply for Customer. For the avoidance of doubt, ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Product far enough in advance not be obliged to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch Plan.
(b) After the Launch Date manufacture any portion of the Product within the Territory, [*] prior to the beginning of each calendar year, ▇▇▇▇ shall provide to Corium [*] for its requirements of the Product. Such [*] forecast will be updated on initial Binding Forecast that requires a [*] basis, and such update shall be received by Corium no later than [*] prior to the first day of each [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding and shall be used by Corium for planning purposes only.
(c) [*] prior to [*], ▇▇▇▇ shall submit to Corium a Firm Order for the Product with a shipment date no sooner than [*] from the date of the Firm Order. Corium shall accept or reject a Firm Order within [*]of its receipt. Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within such [*] period, such Firm Order shall be deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the Product. No change may be made capital investment in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld)Production Facility, unless otherwise agreed by Corden.
(d) Should ▇▇▇▇’▇ Firm Order Non-Binding Forecasts provided by Customer shall be made in good faith, using the degree of diligence that Customer would apply in the event that Customer was engaged to manufacture or otherwise supply the Product for a calendar quarter be less than ▇▇▇▇’▇ most recent itself or another Person. For clarity, as [***]of the Non-binding Forecast becomes [***]of the Binding Forecast, it will automatically become binding except to the extent Customer increase or decrease the amount forecast for such calendar quarter pursuant by more than [***]percent ([***]%) over the previous Non-Binding Forecast. The Parties agree to Section 8.4(b)discuss as soon as practicable any such overage request, provided ▇▇▇▇▇▇ will pay Corium for the costs of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast within [*] of such Firm Order; provided however that Corium shall use commercially reasonable effort efforts to store fulfill such materials under proper storage conditions overage and use any other additional Product requirement of Customer not contemplated by the updated Binding Forecast.
(e) Within [***] Business Days after receipt of each Rolling Forecast, Corden shall submit to Customer a corresponding good faith, non-binding, estimated rolling forecast of Corden’s expected requirements of/for Customer Material based on such materials Rolling Forecast (taking into account any released quantities of Customer Material already on hand at the Production Facility). Each such forecast provided by Corden shall include a reasonable safety stock of Customer Material (sufficient to manufacture at least the next calendar quarter’s Binding Forecast). For clarity, the delivery dates set forth in Corden’s forecast for such Customer Materials shall allow [***] days or as specified in the Product Addendum for future calendar quarters, analytical testing and shall reimburse or credit ▇▇▇▇ for costs of all materials so used for a future calendar quarter within [*] after the end release of such future calendar quarterCustomer Materials by Corden.
Appears in 1 contract
Sources: Commercial Supply Agreement (Acadia Pharmaceuticals Inc)
Forecasts. (a) The ▇▇▇▇ and Corium advisory committee (Committee) will meet at least [*ORPHAN shall provide Supplier with forecasts of ORPHAN’S anticipated [ * ] prior to the Launch Date requirements of the Product Drug for distribution and sale in the purpose United States commencing with the [ * ] period that begins at the time of planning a successful Product launchan FDA approval. Corium Such forecast will prepare a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity and estimated launch date within [*]after receipt of non-binding estimated launch quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Product far enough be provided [ * ] in advance to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch Plan.
(b) After the Launch Date of anticipated FDA approval of the Product within NDA and ORPHAN shall update such [ * ] forecast on a [ * ] basis thereafter. Once FDA approval of the TerritoryDrug is received, [*] ORPHAN will provide Supplier, prior to the beginning of each calendar year[ * ], ▇▇▇▇ shall provide to Corium [*] for with forecasts of its anticipated requirements of the Product. Such [*] forecast will be updated on a [*] basis, and such update shall be received by Corium no later than [*] prior to Drug for the first day of each [*following [ * ]. Except as otherwise Supplier will provide [ * ] anticipated schedule for manufacture and will consult with ORPHAN on schedule changes. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
(a) The forecasts provided herein, these requirements forecasts shall be non-binding and shall be used by Corium to Supplier pursuant to this Section 6.1 are for planning purposes onlyonly and do not constitute a commitment by ORPHAN to have such or any quantity of Drug manufactured by Supplier or a commitment by Supplier to manufacture any quantity of the Drug for ORPHAN during [ * ].
(b) Supplier shall [ * ] manufacture during any [ * ] up to [ * ] of the quantity of the Drug ORPHAN forecasted it would purchase from Supplier during such [ * ] in its most recent forecast covering [ * ]. Supplier will promptly communicate with ORPHAN as to its ability to produce quantities requested.
(c) [*] prior When and as ORPHAN proposes to [*], ▇▇▇▇ shall submit to Corium a Firm Order for the Product with a shipment date no sooner than [*] from the date commence its distribution and sale of the Firm Order. Corium Drug outside the United States, ORPHAN shall accept or reject a Firm Order within [*]supplement its [ * ] forecast accordingly to indicate the additional requirements of its receipt. Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within Drug for such [*] period, such Firm Order shall be deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the Product. No change may be made in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld)purposes.
(d) Should ▇▇▇▇’▇ Firm Order Supplier acknowledges that accurate forecasts of requirements are inherently difficult for a calendar quarter new pharmaceutical product. ORPHAN [ * ]. Accordingly, if [ * ], it will [ * ] ninety (90) days [ * ], in which case ORPHAN [ * ]. The [ * ] delivery of [ * ] are that during such [ * ] (i) ORPHAN shall be less required to purchase [ * ] the amount set forth in the [ * ] and (ii) Supplier shall be required to manufacture [ * ] such amount. If ORPHAN does not deliver a [ * ], Supplier may accept [ * ] use its [ * ] to produce the Drug in accordance with ORPHAN’S purchase orders in a timely manner. It is agreed that this procedure will be used on an exception basis.
(e) If Supplier manufactures the Drug with a lead time of more than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant [ * ], ORPHAN shall not be required to Section 8.4(b)pay any additional storage, ▇▇▇▇ will or pay Corium for the costs Drug sooner than as set forth in Section 7.5 nor shall any advance manufacture lead to a violation of any unused quantities the warranty of such materials ordered for such calendar quarter expiration date set forth in reliance on such forecast within [*] of such Firm Order; provided however that Corium shall use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quarters, and shall reimburse or credit ▇▇▇▇ for costs of all materials so used for a future calendar quarter within [*] after the end of such future calendar quarterSection 8.1.
Appears in 1 contract
Sources: Development and Supply Agreement (Jazz Pharmaceuticals Inc)
Forecasts. (a) The ▇▇▇▇ and Corium advisory committee (Committee) will meet at least [*] prior to the Launch Date of the Product for the purpose of planning a successful Product launch. Corium will prepare a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity and estimated launch date within [*]after receipt of non-binding estimated launch quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Product far enough in advance to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch Plan.
(b) After the Launch Date of the Product within the Territory, [*] prior to the beginning of each calendar year, ▇▇▇▇ shall provide to Corium [*] for its requirements of the Product. Such [*] forecast will be updated on a [*] basis, and such update shall be received by Corium no later than [*] prior to the first day of each [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding and shall be used by Corium for planning purposes only.
(c) [*] prior to [*], ▇▇▇▇ shall submit to Corium a Firm Order for the Product with a shipment date no sooner than [*] from the date of the Firm Order. Corium shall accept or reject a Firm Order within [*]of its receipt. Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within such [*] period, such Firm Order shall be deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the Product. No change may be made in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld).
(d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b), ▇▇▇▇ will pay Corium for the costs of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast within [*] of such Firm Order; provided however that Corium shall use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quarters, and shall reimburse or *Confidential Treatment Requested. credit ▇▇▇▇ for costs of all materials so used for a future calendar quarter within [*] after the end of such future calendar quarter.
Appears in 1 contract
Sources: Development, Manufacturing and Commercialization Agreement
Forecasts. (a) The ▇▇▇▇ and Corium advisory committee (Committee) will meet at least Commencing on the Final Approval Date or such earlier date as may be agreed to between the Parties, OptiNose shall provide Hikma each month with non-binding, rolling [***] forecast of its Product requirements (“Rolling Forecast”). OptiNose shall be obligated to purchase the unit quantity of Products for the [***] of any Rolling Forecast that was requested in the Rolling Forecast for that [***] period (a “Binding Period”). During the first business week of each calendar month, OptiNose will issue a new Rolling Forecast which shall be updated monthly by OptiNose no later than the fifth (5th) business day of each calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] of the going forward [***] Rolling Forecast. Hikma shall participate in periodic sales and operations planning meetings with OptiNose and other suppliers as both Parties reasonably deem appropriate or as OptiNose may reasonably request. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not be required to place any Purchase Order for quantities that otherwise would be applicable for any Binding Period, and OptiNose may, in its sole discretion, cancel or modify any Purchase Order placed prior to the Launch Date Final Approval Date; provided, however, that OptiNose will reimburse Hikma for any out-of-pocket costs reasonably incurred in order for Hikma to be prepared to supply Product for such Purchase Orders (including, without limitation, the cost of Raw Materials purchased by Hikma based on such Rolling Forecasts that cannot otherwise be reasonably used by Hikma or its customers) and any other costs agreed to by the Parties. The Parties will work collaboratively together regarding planning of production of initial Product in anticipation of the Final Approval Date. During the Term of this Agreement, Hikma shall ensure that, subject to utilization of OptiNose Equipment, it has the Capacity to meet all of OptiNose’s requirements for Product for the purpose of planning in a successful Product launch. Corium will prepare a Production Launch Plan for the Product timely manner based on ▇▇▇▇’▇ estimated launch quantity the applicable Rolling Forecast under this Agreement and estimated launch date within [*]after receipt of non-binding estimated launch quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Product far enough in advance to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch Plan.
(b) After the Launch Date of the Product within the Territory, [*] prior subject to the beginning of each calendar year, ▇▇▇▇ shall provide to Corium [*] for its requirements of the Product. Such [*] forecast will be updated on a [*] basis, and such update shall be received by Corium no later than [*] prior to the first day of each [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding and shall be used by Corium for planning purposes only.
(c) [*] prior to [*], ▇▇▇▇ shall submit to Corium a Firm Order for the Product with a shipment date no sooner than [*] from the date of the Firm Order. Corium shall accept or reject a Firm Order within [*]of its receipt. Corium may reject a Firm Order if at the ’s standard lead time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within such [*] period, such Firm Order shall be deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the Product. No change may be made in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld).
(d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b)2.5; provided that if new or additional OptiNose Equipment is required, ▇▇▇▇ Hikma will pay Corium for the costs of any unused quantities of such materials ordered inform OptiNose with sufficient lead time for such calendar quarter in reliance on such forecast within [*] of such Firm Order; provided however that Corium shall OptiNose Equipment to be acquired and qualified for use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quarters, and shall reimburse or credit ▇▇▇▇ for costs of all materials so used for a future calendar quarter within [*] after the end of such future calendar quarterthis Agreement.
Appears in 1 contract
Forecasts. (a) The ▇▇▇▇ and Corium advisory committee (Committee) will meet at Prior to the execution of this Agreement, EyePoint shared with Alimera its 2023 demand forecast for the Product for the U.S. market. At least [***] prior to the Launch Date commencement of each Agreement Year during the Product for Term after the purpose of planning a successful Product launch. Corium will prepare a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity first Agreement Year, EyePoint and estimated launch date within Alimera shall discuss [*]after receipt of **] a non-binding estimated launch plan of Product supply quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders timelines for the Product far enough in advance to meet ▇▇▇▇’▇ launch requirements upcoming Agreement Year based on Corium’s Production Launch [***] (the “Agreement Year Plan”).
(b) After the Launch Date of the Product within the Territory, At least [***][***] prior to the beginning of each calendar yearCalendar Quarter occurring during the Term, Alimera shall deliver to EyePoint a proposed [***] rolling forecast of the quantities of the Product that ▇▇▇▇▇▇▇ shall provide expects to Corium order [***] for its requirements of (the Product“Rolling Forecast”). Such The Parties shall [*] forecast will be updated on a **][*] basis, and such update shall be received by Corium no later than [**] prior to the first day of review each [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding and shall be used Rolling Forecast proposed by Corium for planning purposes only.
(c) [*] prior to [*], ▇▇▇▇▇▇▇ shall submit to Corium a Firm Order for and discuss any limitations on the quantities of Product with a shipment date no sooner than [*] from the date of the Firm Order. Corium shall accept or reject a Firm Order within [*]of its receipt. Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within such [*] period, such Firm Order shall be deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement requested by ▇▇▇▇ to purchase the Product. No change may be made in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Corium (such consent not to be unreasonably withheld).
(d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b), ▇▇▇▇ will pay Corium for the costs of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast within [*] of such Firm Order; provided however that Corium shall use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar quarters, and shall reimburse or credit ▇▇▇▇ for costs [***] of all materials so used the Rolling Forecast based on capacity and other relevant factors. The Parties shall [***] agree on the Rolling Forecast for a future calendar quarter [***] within [***] after EyePoint’s receipt thereof. EyePoint will automatically be deemed to have accepted such portion of the end Rolling Forecast if it has not sent written notice to Alimera of its rejection of such future calendar quarterportion within [***] after EyePoint receives the Rolling Forecast. Such written notice must include [***] its reason for rejecting such portion of the Rolling Forecast and the amounts that it can accept for such period. If EyePoint provides such written notice to ▇▇▇▇▇▇▇, then the Parties shall [***] agree on [***] of the Rolling Forecast within [***] after ▇▇▇▇▇▇▇’s receipt thereof, and if the Parties are not able to agree on such portion of the Rolling Forecast during such period, then EyePoint’s counterproposal in its written notice will automatically be deemed accepted by ▇▇▇▇▇▇▇. The [***]of each Rolling Forecast [***] shall be binding upon the Parties and referred to herein as the “Firm Order”. EyePoint may decline to approve and adjust any portion of the [***] of each Rolling Forecast by providing written notice to Alimera within [***] of receipt thereof; provided, that (i) EyePoint shall approve the [***]s of each Rolling Forecast that is within [***] percent ([***]%) of the quantity requirements for the same period in the immediately preceding Rolling Forecast to the extent previously approved by EyePoint, and (ii) not otherwise act unreasonably in declining to approve and adjusting any such Rolling Forecast. Once approved, the Firm Order may only be changed by [***]. If EyePoint fails to provide its written notice to adjust during such [***] period, then such portion of such Rolling Forecast will automatically be deemed accepted by EyePoint. Attached hereto as Exhibit B is the initial Rolling Forecast, the Firm Order of which is based on [***] demand forecast for the Product for the U.S. market.
Appears in 1 contract
Sources: Commercial Supply Agreement (EyePoint Pharmaceuticals, Inc.)