Common use of Forecasts and Orders Clause in Contracts

Forecasts and Orders. At least seven (7) months prior to the expected receipt of a Regulatory Approval with respect to a Product in a Territory, Alvogen shall provide to Alvotech a twenty-four (24) month forecast of its requirements for such Product (each such forecast, an “Initial Forecast”). Thereafter, Alvogen shall, on a monthly basis, provide to Alvotech a twenty-four (24) month rolling forecast of its anticipated requirements for each Product, and, beginning on the six (6) month anniversary of the Exercise Notice Delivery Date, the quantity of such Product, if any, that a Designated Manufacturer shall manufacture pursuant to Article VIII (the “Rolling Forecast” and, together with the Initial Forecast, the “Forecasts”). As used herein, the term “Short-Term Forecast” means the first seven (7) calendar months of the most recent Forecast, the term “Fixed Requirements Month” means the first, second or third calendar month set forth in a Short-Term Forecast, the term “Variable Requirements Month” means the fourth, fifth, sixth or seventh calendar month set forth in a Short-Term Forecast, and the term “Anticipated Monthly Product Requirements” means, with respect to a given Product, the amounts set forth in the Short-Term Forecast with respect to such Product for a given calendar month. The Forecasts shall represent reasonable estimates for planning purposes only, which Alvogen shall be entitled to revise in future Forecasts, subject to the terms of this Section 7.1. Alvogen may adjust the Anticipated Monthly Product Requirements with respect to a given Product for each Variable Requirements Month set forth in each Short-Term Forecast to an amount not to exceed one hundred twenty-five percent (125%) or to be less than seventy-five percent (75%) of the Anticipated Monthly Product Requirements for such Product set forth in the Short-Term Forecast the first time that such calendar month became a Variable Requirements Month. Alvogen may not change the Anticipated Monthly Product Requirements for a calendar month once such calendar month becomes a Fixed Requirements Month. Subject to the terms of this Section 7.1, Alvogen shall purchase one hundred percent (100%) of the Anticipated Monthly Product Requirements for each Fixed Requirements Month set forth in each Short-Term Forecast less the amount, if any, of the Anticipated Monthly Product Requirements to be manufactured by a Designated Manufacturer in accordance with Article VIII (the “Obligated Purchases”).

Appears in 1 contract

Sources: Product Rights Agreement (Alvotech Lux Holdings S.A.S.)

Forecasts and Orders. At least seven (7a) months Starting on the Effective Date and prior to the expected receipt 15th day of each new calendar quarter during the Initial Term, FHLR or its Affiliates shall furnish to 454 a Regulatory Approval with respect rolling Forecast in quarterly increments indicating, by calendar quarter, the quantities of the Licensed Products that FHLR and its Affiliates intend to a Product in a Territory, Alvogen shall provide to Alvotech a twenty-four order during each calendar quarter of the twelve (2412) month forecast of its requirements for such Product (each such forecast, an “Initial Forecast”). Thereafter, Alvogen shall, on a monthly basis, provide to Alvotech a twenty-four (24) month rolling forecast of its anticipated requirements for each Product, and, beginning on period starting with the six (6) month anniversary first day of the Exercise Notice Delivery Date, the quantity of such Product, if any, that a Designated Manufacturer shall manufacture pursuant to Article VIII (the “Rolling Forecast” and, together with the Initial Forecast, the “Forecasts”)succeeding calendar quarter. As used herein, the term “Short-Term Forecast” means the first seven (7) calendar months of the most recent Forecast, the term “Fixed Requirements Month” means the first, second or third calendar month set forth in a Short-Term Forecast, the term “Variable Requirements Month” means the fourth, fifth, sixth or seventh calendar month set forth in a Short-Term Forecast, and the term “Anticipated Monthly Product Requirements” means, with respect to a given Product, the The amounts set forth for the first calendar quarter included in such Forecast shall constitute a binding commitment upon FHLR and its Affiliates to purchase the Licensed Product quantities in the Short-Term Forecast for such period, pursuant to purchase orders which shall be submitted by FHLR or its Affiliates to 454 in accordance with respect to such Product for a given calendar monthSection 3.5(c). The Forecasts binding Forecast for any such calendar quarter shall be no less than [******************] and no more than [********************************] of the previous non-binding Forecast for such calendar quarter. During the first Contract Year the binding Forecast for any such calendar quarter shall be no less than [**************] and no more than [******************* ************] of the previous non-binding forecast for such calendar quarter. The remaining nine (9) months of each such Forecast shall merely represent reasonable estimates for planning purposes onlyonly and will be good faith Forecasts but, which Alvogen however, shall not obligate FHLR or its Affiliates to purchase the Licensed Product quantities set forth therein. (b) The estimated initial rolling Forecast for Licensed Products added to Exhibit 2 according to Section 2.7 after the Effective Date shall be entitled agreed upon in writing at DO milestone until the above described rolling forecasting process begins and shall be non-binding. Thereafter, Forecasts for such added Licensed Products shall be included in each Forecast to revise be provided pursuant to Section 3.5(a). (c) FHLR or its Affiliates shall place each purchase order with 454 for the Licensed Products to be delivered hereunder in future Forecastswriting. Each such purchase order shall constitute a binding obligation upon FHLR and its Affiliates and shall be confirmed by 454 within two (2) weeks from receipt of the purchase order, such confirmation to include information on the expected delivery date. Notwithstanding the foregoing, 454 shall not be obligated to confirm purchase orders that exceed the binding forecast for the relevant calendar quarter or that are received after the expiration or termination of the Initial Term. 454 shall use best efforts to deliver within four (4) weeks from the receipt of each purchase order such quantity of Licensed Products as is set forth in the binding Forecast for the quarter. For Excess Quantity orders, 454 shall use its commercially reasonable efforts to meet the four (4) weeks delivery date for such purchase orders and shall reasonably adapt its production capacity accordingly. 454 may use the Safety Stock of the Licensed Products to be maintained pursuant to Section 3.7 to meet Excess Quantity orders. (d) During the Initial Term, FHLR or its Affiliates may order spare parts from 454 from time to time with prices as specified in Exhibit 7 and as further set out below. Exhibit 7 shall be amended annually by the Joint Steering Committee as proposed by the Operations Steering Committee based on the criteria set forth below. 454 shall deliver such spare parts to FHLR or its Affiliates as soon as reasonably available, but in any event within thirty (30) days of the relevant purchase order. Any such spare parts which are to be used by FHLR or its Affiliates for technical service during the warranty period shall be provided free of charge to FHLR or its Affiliates. For any such spare parts which are to be used in connection with technical service which is to occur after the warranty period, spare part prices shall be based on the Instrument Transfer Price using [***************************************** ************************************], as initially provided for Rev. 1.0 in Exhibit 7. FHLR shall provide 454 with any information reasonably requested by 454 to confirm any amounts due to 454 hereunder based on the use of spare parts and such information shall be subject to audit as provided in Article 4. (e) FHLR’s or its Affiliates’ purchase orders may not modify any terms of this Agreement or add any terms not set forth herein. Any such additional terms or modifications shall have no effect. In the event there is any confusion as to the obligations of the Parties regarding a particular Licensed Product purchase order, the Parties agree that the resolution of such issue shall be controlled solely by the terms of this Section 7.1. Alvogen may adjust the Anticipated Monthly Product Requirements with respect to a given Product for each Variable Requirements Month set forth in each Short-Term Forecast to an amount not to exceed one hundred twenty-five percent (125%) or to be less than seventy-five percent (75%) of the Anticipated Monthly Product Requirements for such Product set forth in the Short-Term Forecast the first time that such calendar month became a Variable Requirements Month. Alvogen may not change the Anticipated Monthly Product Requirements for a calendar month once such calendar month becomes a Fixed Requirements Month. Subject to the terms of this Section 7.1, Alvogen shall purchase one hundred percent (100%) of the Anticipated Monthly Product Requirements for each Fixed Requirements Month set forth in each Short-Term Forecast less the amount, if any, of the Anticipated Monthly Product Requirements to be manufactured by a Designated Manufacturer in accordance with Article VIII (the “Obligated Purchases”)Agreement.

Appears in 1 contract

Sources: License, Supply and Distribution Agreement (Curagen Corp)

Forecasts and Orders. At 3.3.1 In accordance with the requirements set forth in Exhibit A, at least seven ten (710) months days prior to the expected receipt first day of a Regulatory Approval with respect to a Product in a Territoryeach calendar quarter during the Initial Term and any renewal term, Alvogen Tutogen shall provide AlloSource with a written non-binding forecast as to Alvotech a twenty-four Tutogen’s estimated requirements of Products for each of the following twelve (2412) month forecast calendar months, the first three (3) months of its requirements which shall be binding. On or before the first day of each month, Tutogen shall issue binding orders for such Product (each such forecast, an “Initial Forecast”). Thereafter, Alvogen shall, on a monthly basis, provide to Alvotech a twenty-four (24) month rolling forecast for the quantities of its anticipated requirements for each Product, and, beginning on the six (6) month anniversary of the Exercise Notice Delivery Date, the quantity of such Product, if any, that a Designated Manufacturer shall manufacture pursuant to Article VIII (the “Rolling Forecast” and, together with the Initial Forecast, the “Forecasts”). As used herein, the term “Short-Term Forecast” means the first seven (7) calendar months of the most recent Forecast, the term “Fixed Requirements Month” means the first, second or third calendar month Products set forth in a Short-Term Forecastsuch forecast. AlloSource shall have five (5) business days to notify Tutogen of rejection of such binding order and reason for such rejection. If no notice of rejection is given within such five (5) business day period, the term “Variable Requirements Month” means binding order shall be considered accepted by AlloSource. AlloSource shall make reasonable business efforts to fill such binding orders within thirty (30) days, but no later than ninety (90) days of such binding orders. If AlloSource fails to fill a binding order that was accepted by AlloSource within ninety (90) days of the fourthdate of such binding order, fifththen Tutogen may cancel such binding order and may fill such order from another source. 3.3.2 In the event that Tutogen does not place and accept orders for Products in accordance with the minimum monthly requirements specified in Exhibit A, sixth Tutogen shall be required to pay AlloSource the reimbursement fees, in accordance with Section 6 below, for the minimum monthly requirements less the number of Products which are ordered and accepted by Tutogen. 3.3.3 AlloSource may supply and Tutogen shall accept from AlloSource Tissues, Processed Tissues and Allografts in an amount equal to or seventh calendar month up to ten percent (10%) greater than the quantities set forth in a Short-Term Forecast, Exhibit A hereto and the term “Anticipated Monthly Product Requirements” means, with respect to a given Product, the amounts set forth in the Short-Term Forecast with respect to such Product for a given calendar month. The Forecasts shall represent reasonable estimates for planning purposes only, which Alvogen shall be entitled to revise in future Forecasts, subject to the terms of this Section 7.1. Alvogen may adjust the Anticipated Monthly Product Requirements with respect to a given Product for each Variable Requirements Month set forth in each Short-Term Forecast to an amount not to exceed one hundred twenty-five percent binding order (125%) or to be less than seventy-five percent (75%) of the Anticipated Monthly Product Requirements for such Product set forth higher quantity if mutually agreed in the Short-Term Forecast the first time that such calendar month became a Variable Requirements Month. Alvogen may not change the Anticipated Monthly Product Requirements for a calendar month once such calendar month becomes a Fixed Requirements Month. Subject to the terms of this Section 7.1, Alvogen shall purchase one hundred percent (100%) of the Anticipated Monthly Product Requirements for each Fixed Requirements Month set forth in each Short-Term Forecast less the amount, if any, of the Anticipated Monthly Product Requirements to be manufactured by a Designated Manufacturer in accordance with Article VIII (the “Obligated Purchases”writing). 3.3.4 AlloSource shall ship Products to Tutogen at the following address: Tutogen Medical, Inc. 13709 Progress Blvd., Box 19 South Wing ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ 3.3.5 Tutogen shall be responsible for expenses associated with the shipment of Products from AlloSource to Tutogen. Risk of loss and title to such Products shall pass to Tutogen upon shipment. 3.3.6 EXCEPT AS SET FORTH HEREIN, ALLOSOURCE MAKES NO WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.

Appears in 1 contract

Sources: Tissue Procurement, Processing and Supply Agreement (Tutogen Medical Inc)

Forecasts and Orders. At 2.3.1 Not less than twelve (12) months prior to its first purchase of Ingredient for use in the manufacture of Products to be sold to Third Parties, Wyeth-Ayerst shall provide GalaGen with a written forecast (by Calendar Quarter) of the quantity of Ingredient that Wyeth-Ayerst desires to have delivered to it during the first twelve (12) month period of Product sales. Within six (6) months prior to its first purchase of Ingredient, Wyeth-Ayerst shall provide GalaGen with an updated forecast for the first twelve (12) month period (by Calendar Quarter), and by the beginning of such twelve (12) month period shall provide GalaGen with an updated forecast for the last three (3) Calendar Quarters of such twelve (12) month period and for the Calendar Quarter following immediately thereafter. Thereafter, at least seven ninety (790) days before the end of each subsequent Calendar Quarter, Wyeth-Ayerst shall provide a written updated forecast (by Calendar Quarter) in accordance with the provisions of Section 2.3.2 hereof. 2.3.2 Each successive forecast shall update the forecast previously given for the last three (3) Calendar Quarters covered and add a forecast for the Calendar Quarter following immediately thereafter, to enable GalaGen to have sufficient information to schedule its or its sub-contractors' manufacturing operations to meet Wyeth-Ayerst's forecasted requirements of the Ingredient. GalaGen acknowledges that such forecasts are only estimates of Wyeth-Ayerst's purchase requirements of the Ingredient and that Wyeth-Ayerst shall not be bound by any such estimate, except that after Regulatory Approval the first Calendar Quarter of each successive forecast so provided shall represent a binding commitment of Wyeth-Ayerst to purchase and of GalaGen to supply such forecasted quantity of Ingredient in a timely manner, subject to adjustment within the limits set forth in Section 2.3.4 hereof. 2.3.3 Wyeth-Ayerst shall order and maintain reasonable inventories of the Ingredient, having due regard to its current and forecasted sales volumes for the Products. Wyeth-Ayerst shall issue to GalaGen firm purchase orders for each delivery not later than two (2) months prior to the expected receipt of a Regulatory Approval with respect to a Product in a Territory, Alvogen requested delivery date. Such purchase orders shall provide to Alvotech a twenty-four (24) month forecast of its requirements for such Product (each such forecast, an “Initial Forecast”). Thereafter, Alvogen shall, on a monthly basis, provide to Alvotech a twenty-four (24) month rolling forecast of its anticipated requirements for each Product, and, beginning on the six (6) month anniversary of the Exercise Notice Delivery Date, specify the quantity of such Product, if any, that a Designated Manufacturer shall manufacture pursuant to Article VIII (the “Rolling Forecast” and, together with the Initial Forecast, the “Forecasts”). As used herein, the term “Short-Term Forecast” means the first seven (7) calendar months of the most recent Forecast, the term “Fixed Requirements Month” means the first, second or third calendar month set forth in a Short-Term Forecast, the term “Variable Requirements Month” means the fourth, fifth, sixth or seventh calendar month set forth in a Short-Term ForecastIngredient desired, and the term “Anticipated Monthly Product Requirements” means, place(s) to which and the manner and dates by which delivery is to be made. To the extent the terms of any purchase order or acknowledgment thereof are inconsistent with respect to a given Product, the amounts set forth in the Short-Term Forecast with respect to such Product for a given calendar month. The Forecasts shall represent reasonable estimates for planning purposes only, which Alvogen shall be entitled to revise in future Forecasts, subject to the terms of this Section 7.1. Alvogen may adjust Agreement, the Anticipated Monthly Product Requirements with respect to a given Product for each Variable Requirements Month set forth terms of this Agreement shall control. 2.3.4 The quantity of Ingredient ordered by Wyeth-Ayerst in each Short-Term Forecast to an amount any Calendar Quarter shall not to exceed one hundred twenty-five percent (125%) or to be less than seventy-five percent (75%) of the Anticipated Monthly Product Requirements quantity specified in the last binding forecast provided by Wyeth-Ayerst for such Product set forth Calendar Quarter. Additionally, GalaGen shall not be obligated to supply that quantity of Ingredient in the Short-Term Forecast the first time any Calendar Quarter that such calendar month became a Variable Requirements Month. Alvogen may not change the Anticipated Monthly Product Requirements for a calendar month once such calendar month becomes a Fixed Requirements Month. Subject to the terms of this Section 7.1, Alvogen shall purchase is more than one hundred and twenty-five percent (100125%) of the Anticipated Monthly Product Requirements last binding forecast provided by Wyeth-Ayerst for each Fixed Requirements Month the Calendar Quarter in question; PROVIDED, HOWEVER, that GalaGen shall endeavor to take all reasonable steps to fill purchase orders for the Ingredient in excess of such amount. 2.3.5 All estimates shall be prepared in good faith in order to facilitate GalaGen's efficient manufacture and shipment of the Ingredient in compliance with this Agreement, and except as set forth in each ShortSection 2.3.2 will not be binding upon Wyeth-Term Forecast less Ayerst or GalaGen in any way and Wyeth-Ayerst shall not be responsible for any loss or expense of GalaGen's arising from the amountforecast. 2.3.6 Notwithstanding any other provision of this Agreement, if anyGalaGen in no event shall be obligated to supply Wyeth-Ayerst with an amount of Ingredient that exceeds seventy percent (70%) of GalaGen's total capacity for the manufacture of Ingredient and all other products. In the event Wyeth-Ayerst provides GalaGen with good faith forecasts that exceed such capacity, GalaGen agrees that it will use its Commercially Reasonable Efforts to seek and employ subcontractors, as permitted under Section 2.1 hereof, to manufacture such excess amounts of the Anticipated Monthly Product Requirements to be manufactured by a Designated Manufacturer in accordance with Article VIII (the “Obligated Purchases”)Ingredient on commercially reasonable terms.

Appears in 1 contract

Sources: Manufacturing and Supply Agreement (Galagen Inc)

Forecasts and Orders. At least seven (7a) months prior to the expected receipt of Buyers have provided Sellers with a Regulatory Approval with respect to a Product in a Territory, Alvogen shall provide to Alvotech a twentynon-four (24) month binding forecast of its purchases of Products for the Term within the Territory, said forecast being attached hereto as EXHIBIT B. (b) Within ten (10) business days of the Effective Date, Buyers shall update the forecast described in Paragraph 4.1 (a) Such amended forecast shall be a non-binding (except as provided in Paragraph 14.1(c)) forecast of its purchases of Products for the term with the Territory ("Annual Forecast"). Each Product is to be identified in such Annual Forecast by individual SKU. (a) Every thirty (30) days during the term hereof, Buyers shall provide Sellers with a good faith, non-binding forecast of its purchases of Products during the next three (3) month period. Such forecasts shall be made recognizing the requirements for Batch Sizes and Lead Times as defined in Paragraph 4.3(b) hereof. (b) Sellers have presented Buyers with, and Buyers acknowledge the receipt of, a document listing the Products, the batch size used in the production of each such Product ("Batch Size"), and the lead times required to manufacture each of said Products ("Lead Times"), such document being appended hereto as EXHIBIT D. (a) Buyers shall authorize the manufacture and packaging of a Product by issuing a purchase order ("Purchase Order") to Sellers and Sellers shall manufacture and package, or have packaged, such Products. Each Purchase Order shall be in a form and contain terms previously agreed to by the parties. Each ▇▇▇▇▇▇▇▇ ▇▇▇er shall correspond to a total quantity of Product which is a whole number multiple of the applicable Batch Size as set forth in EXHIBIT D. The proposed delivery date recited in the Purchase Order shall also be equal to or greater than the applicable Lead Time for each such forecastProduct as set forth in EXHIBIT D. Each Purchase Order shall further specify the following: (i) the identity of Product by SKU, an “Initial Forecast”). Thereafter, Alvogen shall, on a monthly basis, provide to Alvotech a twenty-four and (24ii) month rolling forecast of its anticipated requirements for each Product, and, beginning on the six (6) month anniversary of the Exercise Notice Delivery Date, the quantity of such Product, if any, that . (b) Sellers shall promptly acknowledge each Purchase Order by signing and returning to Buyers the acknowledgment copy of each Purchase Order promptly after its receipt. Failure of the Sellers to deliver to Buyers a Designated Manufacturer written notice objecting to a Purchase Order within five (5) business days after receipt of the Purchase Order shall manufacture pursuant to Article VIII constitute Sellers' acceptance of the Purchase Order. (c) In the “Rolling Forecast” and, together with event of any conflict between the Initial Forecastterms and conditions of this Agreement and the terms and conditions of Buyers' Purchase Order or any other document, the “Forecasts”terms and conditions of this Agreement shall be controlling. 4.4 Buyers may request Sellers to accept an increase in Buyers' Annual Forecast of Product(s). As used herein, the term “Short-Term Forecast” means the first seven Sellers' obligation with respect thereto shall solely be to exercise commercially reasonable efforts to accommodate Buyers' request so long as (7a) calendar months such increase represents a whole number multiple of the most recent ForecastBatch Size of each such Product, (b) the term “Fixed Requirements Month” means period until the firstproposed date(s) of delivery is greater than the applicable Lead Time for each such Product, second or third calendar month set forth in a Short-Term Forecast, (c) the term “Variable Requirements Month” means proposed date(s) of delivery is within the fourth, fifth, sixth or seventh calendar month set forth in a Short-Term ForecastTerm, and (d) the term “Anticipated Monthly Product Requirements” means, with respect to a given Product, the amounts set forth in the Short-Term Forecast with respect to such Product for a given calendar month. The Forecasts shall proposed increase does not represent reasonable estimates for planning purposes only, which Alvogen shall be entitled to revise in future Forecasts, subject to the terms of this Section 7.1. Alvogen may adjust the Anticipated Monthly Product Requirements with respect to a given Product for each Variable Requirements Month set forth in each Short-Term Forecast to an amount not to exceed one hundred twenty-five more than fifty percent (125%) or to be less than seventy-five percent (7550%) of the Anticipated Monthly Product Requirements for Annual Forecast of such Product set forth in the Short-Term Forecast the first time that such calendar month became a Variable Requirements Month. Alvogen may not change the Anticipated Monthly Product Requirements for a calendar month once such calendar month becomes a Fixed Requirements Month. Subject to the terms of this Section 7.1, Alvogen shall purchase one hundred percent (100%) of the Anticipated Monthly Product Requirements for each Fixed Requirements Month set forth in each Short-Term Forecast less the amount, if any, of the Anticipated Monthly Product Requirements to be manufactured by a Designated Manufacturer in accordance with Article VIII (the “Obligated Purchases”)Product.

Appears in 1 contract

Sources: Asset Purchase Agreement (Selfcare Inc)

Forecasts and Orders. 5.3.1 At least seven (7) months *** days prior to the expected receipt first day of each Semiannual Period during the Term, ViroPharma shall deliver to Sanquin a Regulatory Approval with respect to a Product in a Territorywritten, Alvogen shall provide to Alvotech a twenty-four (24) good faith *** month forecast of its requirements for such the volume of ViroPharma Product that ViroPharma then anticipates will be required to be produced and delivered to ViroPharma during that *** month period (each such forecast, an the Initial Semiannual Forecast”). Thereafter, Alvogen shall, on a monthly basis, provide to Alvotech a twenty-four (24) month rolling forecast The first *** months of its anticipated the Semiannual Forecast shall contain ViroPharma’s volume requirements for each Product, and, beginning on the six (6) ViroPharma Product by month anniversary of the Exercise Notice Delivery Date, the quantity of such Product, if any, that a Designated Manufacturer shall manufacture pursuant to Article VIII (the “Rolling Forecast” and, together with the Initial Forecast, the “ForecastsFirm Portion”), which shall be binding on the Parties. As used herein, the term “Short-Term Forecast” means the first seven (7) calendar The remaining *** months of the most recent ForecastSemiannual Forecast shall contain ViroPharma’s non-binding then-anticipated volume requirements for ViroPharma Product by calendar *** only. 5.3.2 As part of each Firm Portion, ViroPharma shall place firm orders with Sanquin, setting forth Units (or any other measurement agreeable to both Parties), the term “Fixed Requirements Month” means the firstvarious countries such Units shall be delivered to, second or third calendar month set forth in a Short-Term Forecast, the term “Variable Requirements Month” means the fourth, fifth, sixth or seventh calendar month set forth in a Short-Term Forecast, anticipated delivery dates and the term “Anticipated Monthly Product Requirements” means, shipping instructions with respect to a given Product, the amounts set forth in the Short-Term Forecast with respect to such each shipment of ViroPharma Product for delivery. Actual supply and shipment shall then take place pursuant to purchase orders which are in a given calendar month. The Forecasts shall represent reasonable estimates for planning purposes only, which Alvogen shall be entitled form and according to revise in future Forecasts, subject a working procedure mutually acceptable to ViroPharma and Sanquin and consistent with the terms of this Section 7.1Agreement. 5.3.3 Sanquin shall not be obligated to accept any Firm Portion to the extent the quantity of ViroPharma Product ordered pursuant to such Firm Portion exceeds ***% of the quantity of ViroPharma Product that was anticipated to be ordered for the same Semiannual Period according to the immediately preceding Semiannual Forecast. Alvogen may adjust Notwithstanding the Anticipated Monthly foregoing limitations, Sanquin shall use commercially reasonable efforts to fill such order for such excess quantities from available supplies, and Sanquin shall use commercially reasonable efforts to notify ViroPharma within *** Business Days after receipt of an order of Sanquin’s ability to fill any amounts of such order in excess of the quantities that Sanquin is obligated to supply. ViroPharma shall notify Sanquin as soon as possible of an increase in ViroPharma’s requirements for ViroPharma Product Requirements with respect materially in excess of the limits set forth herein. In any event the quantity of ViroPharma Product that Sanquin is obligated to a given supply to ViroPharma under this Agreement shall in any year not exceed the maximum amount as established for the ViroPharma Portion in the Capacity Schedule for such year. 5.3.4 In the event that ViroPharma submits any Firm Portion for ViroPharma Product for each Variable Requirements Month set forth in each Short-Term Forecast to an amount not to exceed one hundred twenty-five percent (125%) or less than ***% of the quantity of ViroPharma Product anticipated to be less than seventy-five percent ordered for the same Semiannual Period according to immediately preceding Semiannual Forecast, Sanquin nevertheless shall have the right to supply and ship to ViroPharma (75%in accordance with the shipping instructions most recently supplied by ViroPharma) ***% of the Anticipated Monthly Product Requirements for such quantity of ViroPharma Product set forth in the Short-Term immediately preceding Semiannual Forecast for such Semiannual Period. ViroPharma shall notify Sanquin as soon as possible of a decrease in ViroPharma’s requirements for ViroPharma Product materially below the first time that such calendar month became a Variable Requirements Month. Alvogen may not change the Anticipated Monthly Product Requirements for a calendar month once such calendar month becomes a Fixed Requirements Month. Subject to the terms of this Section 7.1, Alvogen shall purchase one hundred percent (100%) of the Anticipated Monthly Product Requirements for each Fixed Requirements Month limits set forth herein. In the event of such a decrease, Sanquin shall use commercially reasonable efforts, but shall not be required, to reduce accordingly. 5.3.5 Notwithstanding the foregoing, the Parties may mutually agree to a forecasting and ordering procedure in each Short-Term Forecast less the amount, if any, advance of the Anticipated Monthly Product Requirements to be manufactured by a Designated Manufacturer in accordance with Article VIII (the “Obligated Purchases”)Launch.

Appears in 1 contract

Sources: Manufacturing and Distribution Agreement (Viropharma Inc)

Forecasts and Orders. At least seven (7a) months Within ninety (90) days of the date of this Agreement, Jubilant shall provide Trinity with a written list of all APIs manufactured by Jubilant and its Affiliates and that are available for supply by Jubilant to Trigen as Jubilant Products pursuant to this Agreement. Within one hundred twenty (120) days after the date of this Agreement, (i) Jubilant and Trigen shall agree upon the initial Jubilant Products to be supplied by Jubilant to Trigen pursuant to this Agreement, which Jubilant Products shall be set forth on Schedule A attached hereto and signed by each of the parties, and (ii) Trigen shall place a binding purchase order for such Jubilant Products for the third calendar quarter of 2005. (b) Thereafter, not later than thirty (30) business days prior to the expected receipt start of a Regulatory Approval with respect to a Product in a Territoryeach calendar quarter during the Term, Alvogen Trigen shall provide to Alvotech Jubilant a twenty-rolling forecast that estimates the quantity of each Jubilant Product to be purchased by Trigen during the upcoming four (24) month calendar quarters. The first calendar quarter of each such forecast of its requirements will constitute a purchase order from Trigen binding on both parties hereto for the amounts forecasted for each Jubilant Product for such Product (calendar quarter. Except for the first calendar quarter of each such rolling forecast, which constitutes a binding purchase order, such forecast will constitute an “Initial Forecast”). Thereafter, Alvogen shall, on a monthly basis, provide to Alvotech a twenty-four (24) month rolling forecast estimate of its anticipated Trigen’s requirements for each Jubilant Product, andwhich is supplied for the convenience of Jubilant, beginning is non-binding on Trigen, and will not be constitute an order of Jubilant Product. (c) Trigen shall place orders for the six (6) month anniversary of the Exercise Notice Delivery DateJubilant Products on Trigen’s standard form purchase order on a calendar quarter basis. Each such purchase order must specify each Jubilant Product ordered, the quantity of such Product, if any, that a Designated Manufacturer shall manufacture pursuant to Article VIII (the “Rolling Forecast” and, together with the Initial Forecasteach Jubilant Product ordered, the “Forecasts”). As used herein, the term “Short-Term Forecast” means the first seven (7) calendar months place of the most recent Forecast, the term “Fixed Requirements Month” means the first, second or third calendar month set forth in a Short-Term Forecast, the term “Variable Requirements Month” means the fourth, fifth, sixth or seventh calendar month set forth in a Short-Term Forecast, delivery and the term “Anticipated Monthly Product Requirements” means, with respect to a given Product, delivery date(s) and the amounts set forth in the Short-Term Forecast with respect to such Product for a given calendar month. The Forecasts shall represent reasonable estimates for planning purposes only, date of shipment which Alvogen shall be entitled to revise in future Forecasts, subject to the terms of this Section 7.1. Alvogen may adjust the Anticipated Monthly Product Requirements with respect to a given Product for each Variable Requirements Month set forth in each Short-Term Forecast to an amount must not to exceed one hundred twenty-five percent (125%) or to be less than seventy-five percent thirty (75%30) days after the date of such purchase order. In the Anticipated Monthly Product Requirements for such Product set forth in the Short-Term Forecast the first time that such calendar month became event of a Variable Requirements Month. Alvogen may not change the Anticipated Monthly Product Requirements for a calendar month once such calendar month becomes a Fixed Requirements Month. Subject to conflict between the terms and conditions of any purchase order and this Agreement, the terms and conditions of this Section 7.1, Alvogen shall purchase one hundred percent (100%) of the Anticipated Monthly Product Requirements for each Fixed Requirements Month set forth in each Short-Term Forecast less the amount, if any, of the Anticipated Monthly Product Requirements to be manufactured by a Designated Manufacturer in accordance with Article VIII (the “Obligated Purchases”)Agreement will prevail.

Appears in 1 contract

Sources: Supply Agreement (Cadista Holdings Inc.)

Forecasts and Orders. 4.4.1. At least seven (7) months *** days prior to the expected receipt first day of each Semiannual Period during the Term, VBI shall deliver to Sanquin a Regulatory Approval with respect to a Product in a Territorywritten, Alvogen shall provide to Alvotech a twenty-four (24) good faith *** month forecast of its requirements for such the volume of Product that VBI then anticipates will be required to be produced and delivered to VBI during that *** month period (each such forecast, an the Initial Semiannual Forecast”). Thereafter, Alvogen shall, on a monthly basis, provide to Alvotech a twenty-four (24) month rolling forecast The first *** months of its anticipated the Semiannual Forecast shall contain VBI’s volume requirements for each Product, and, beginning on the six (6) Product by month anniversary of the Exercise Notice Delivery Date, the quantity of such Product, if any, that a Designated Manufacturer shall manufacture pursuant to Article VIII (the “Rolling Forecast” and, together with the Initial Forecast, the “ForecastsFirm Portion”), which shall be binding on the Parties. As used herein, the term “Short-Term Forecast” means the first seven (7) calendar The remaining *** months of the most recent ForecastSemiannual Forecast shall contain VBI’s non-binding then-anticipated volume requirements for Product by calendar *** only. 4.4.2. As part of each Firm Portion, VBI shall place firm orders with Sanquin, setting forth Units (or any other measurement agreeable to both Parties), the term “Fixed Requirements Month” means the firstvarious countries such Units shall be delivered to, second or third calendar month set forth in a Short-Term Forecast, the term “Variable Requirements Month” means the fourth, fifth, sixth or seventh calendar month set forth in a Short-Term Forecast, anticipated delivery dates and the term “Anticipated Monthly Product Requirements” means, shipping instructions with respect to a given Product, the amounts set forth in the Short-Term Forecast with respect to such each shipment of Product for delivery. Actual supply and shipment shall then take place pursuant to purchase orders which are in a given calendar month. The Forecasts shall represent reasonable estimates for planning purposes only, which Alvogen shall be entitled form and according to revise in future Forecasts, subject a working procedure mutually acceptable to VBI and Sanquin and consistent with the terms of this Section 7.1Agreement. 4.4.3. Alvogen may adjust Sanquin shall not be obligated to accept any Firm Portion to the Anticipated Monthly extent the quantity of Product Requirements with respect ordered pursuant to a given such Firm Portion exceeds ***% of the quantity of Product that was anticipated to be ordered for the same Semiannual Period according to the immediately preceding Semiannual Forecast. Notwithstanding the foregoing limitations, Sanquin shall use commercially reasonable efforts to fill such order for such excess quantities from available supplies, and Sanquin shall use commercially reasonable efforts to notify VBI within *** days after receipt of an order of Sanquin’s ability to fill any amounts of such order in excess of the quantities that Sanquin is obligated to supply. VBI shall notify Sanquin as soon as possible of an increase in VBI’s requirements for Product materially in excess of the limits set forth herein. In any event the quantity of Product required to be supplied by Sanquin to VBI under this Agreement shall in any calendar year not exceed the maximum amount as established for the VBI Portion in the Capacity Schedule for such year unless agreed otherwise between the Parties. 4.4.4. In the event that VBI submits any Firm Portion for Product for each Variable Requirements Month set forth in each Short-Term Forecast to an amount not to exceed one hundred twenty-five percent (125%) or less than the ***% of the quantity of Product that was anticipated to be less than seventy-five percent ordered for the same Semiannual Period according to the immediately preceding Semiannual Forecast, Sanquin nevertheless shall have the right to supply and ship to VBI (75%in accordance with the shipping instructions most recently supplied by VBI) ***% of the Anticipated Monthly Product Requirements for such quantity of Product set forth in the Short-Term immediately preceding Semiannual Forecast for such Semiannual Period. VBI shall notify Sanquin as soon as possible of a decrease in VBI’s requirements for Product materially below the first time that such calendar month became a Variable Requirements Month. Alvogen may not change the Anticipated Monthly Product Requirements for a calendar month once such calendar month becomes a Fixed Requirements Month. Subject to the terms of this Section 7.1, Alvogen shall purchase one hundred percent (100%) of the Anticipated Monthly Product Requirements for each Fixed Requirements Month limits set forth herein. In the event of such a decrease, Sanquin shall use commercially reasonable efforts, but shall not be required, to reduce accordingly. 4.4.5. Notwithstanding the foregoing, the Parties may mutually agree to a forecasting and ordering procedure in each Short-Term Forecast less the amount, if any, advance of the Anticipated Monthly Product Requirements to be manufactured by a Designated Manufacturer in accordance with Article VIII (the “Obligated Purchases”)any Launch.

Appears in 1 contract

Sources: Distribution and Manufacturing Services Agreement (Viropharma Inc)

Forecasts and Orders. At least seven 3.1 Forecasting and ordering of Product(s) under this Agreement shall be conducted: (7A) months prior to on a pull Manufacturing basis in respect of the expected receipt Products as set out in clauses 3.2 and 3.4; or (B) on a Toll Manufacturing Basis in respect of a Regulatory Approval with respect to a Product Products that are Tolled Products as set out in a Territoryclause 5 (Toll Manufacture) and Exhibit 7 (Toll Manufacturing Provisions), Alvogen and (C) on the fifth (5th) Business Day of each calendar month commencing not later than the calendar month following the calendar month in which the Effective Date falls (or at such other dates as may be agreed between the Parties), the Purchaser shall provide to Alvotech the Supplier a rolling demand forecast schedule (in such physical written format (as opposed to a data exchange) exchangeable by email as is agreed by the Parties) which shall align with the applicable Gating Plan for that Gating Year and comprise a good faith estimate of its anticipated aggregate monthly requirements for Products for at least the following twenty-four (24) month forecast months or, in each case, such shorter period remaining under the Term (including any proposed extension thereof), in accordance with clause 3.2 ( the “Forecast Schedule”). (A) Manufacturing and supply of its Products under this Agreement shall be pursuant to the Forecast Schedules and to the Firm Orders submitted by the Purchaser, as further described in this clause 3.2. (B) The initial Forecast Schedule is attached to this Agreement at Exhibit 14 (Initial Product Forecast Schedule) and the Parties agree that the Purchaser and the Supplier shall be bound by the volumes of Products shown in the Firm Zone of such initial Forecast Schedule as at the Effective Date. The initial Forecast Schedule shall reflect the migration of all orders that are in progress immediately prior to the Effective Date. (C) Provided that the volumes of Products shown in the Firm Zone of each Forecast Schedule align with the requirements of the Gating Plan in respect of such Products, such volumes shall be deemed to be firm orders binding on the Purchaser and the Supplier, and the quantities included for such each Product in any Firm Zone may not be varied in any subsequent Forecast Schedule unless the Supplier agrees in writing (each such forecast, an firm order being a Initial ForecastFirm Order”). Thereafter, Alvogen shall, on a monthly basis, provide to Alvotech a twenty-four (24) month rolling forecast Each Firm Order shall be for not less than the Minimum Order Quantity of its anticipated requirements for each Product, Product and, beginning on if greater than the six (6) month anniversary Minimum Order Quantity, shall be for the Minimum Order Quantity plus one or more multiples of the Exercise Notice Minimum Order Quantity. If the volumes specified in the Firm Order do not comply with this requirement then such variation to such volumes must be agreed between the Parties as part of the Firm Order confirmation process set out at 3.2(E). (D) The Purchaser shall submit each Forecast Schedule either electronically or by such other means that the Manufacturing and Supply Team shall determine and to such location as reasonably requested by the Supplier in writing. No oral communications shall comprise a commitment to supply. Each Firm Order shall specify the volumes of Product required and the Purchaser’s requested Delivery Datedate in accordance with the applicable Lead Time requirements as set out in Exhibit 1 (Products). (E) The Supplier shall respond to each Firm Order that complies with the requirements of this clause 3.2 (including the applicable Gating Plan): (i) within two (2) Business Days of receipt (or such other date as agreed between the Parties) to acknowledge receipt of the Firm Order; and (ii) within ten (10) Business Days of receipt (or such other date as agreed between the Parties) to confirm the applicable order Delivery date and the volumes of Product required. In the event that the Supplier fails to respond to any Firm Order within ten (10) Business Days after acknowledging it, the quantity Supplier shall be deemed to have acknowledged and accepted that Firm Order. Unless otherwise agreed by the Parties, the Supplier shall be obliged to acknowledge Firm Orders which comply with the requirements of this clause 3.2 without proposed amendments. The response (or deemed response) will include confirmation of the Delivery date. To the extent that the Supplier proposes an amendment to the Firm Order, the Purchaser shall respond to any proposed amendments to the Firm Order within ten (10) Business Days confirming whether it accepts or rejects such Productproposed amendments. If the Purchaser: (iii) accepts such amendments, if any, that a Designated Manufacturer shall manufacture pursuant to Article VIII (the “Rolling Forecast” and, Firm Order together with the Initial Forecastrelevant amendments shall be deemed to be acknowledged and accepted by the Supplier and shall be binding on both Parties; or (iv) rejects such proposed amendments; the Parties will discuss the proposed amendments in good faith as promptly as practicable, the “Forecasts”). As used herein, the term “Short-Term Forecast” means the first seven but not more than five (75) calendar months of the most recent Forecast, the term “Fixed Requirements Month” means the first, second or third calendar month set forth in a Short-Term Forecast, the term “Variable Requirements Month” means the fourth, fifth, sixth or seventh calendar month set forth in a Short-Term Forecast, and the term “Anticipated Monthly Product Requirements” means, with respect to a given Product, the amounts set forth in the Short-Term Forecast with respect to Business Days following such Product for a given calendar monthrejection. The Forecasts shall represent reasonable estimates for planning purposes only, which Alvogen Parties agree that if the Parties cannot agree an amendment to the Firm Order pursuant to this clause 3.2(E) that the Firm Order initially submitted without the suggested amendments shall be entitled to revise in future Forecasts, subject binding on the Parties to the terms of this Section 7.1. Alvogen may adjust the Anticipated Monthly Product Requirements with respect to a given Product for each Variable Requirements Month set forth in each Short-Term Forecast to an amount not to exceed one hundred twenty-five percent (125%) or to be less than seventy-five percent (75%) of the Anticipated Monthly Product Requirements for such Product set forth in the Short-Term Forecast the first time that such calendar month became a Variable Requirements Month. Alvogen may not change the Anticipated Monthly Product Requirements for a calendar month once such calendar month becomes a Fixed Requirements Month. Subject to the terms of this Section 7.1, Alvogen shall purchase one hundred percent (100%) of the Anticipated Monthly Product Requirements for each Fixed Requirements Month set forth in each Short-Term Forecast less the amount, if any, of the Anticipated Monthly Product Requirements to be manufactured by a Designated Manufacturer extent it is in accordance with Article VIII (this clause 3.2 and the “Obligated Purchases”).applicable Gating Plan, provided that the Supplier may refer the matter for resolution in accordance with clause

Appears in 1 contract

Sources: Manufacturing and Supply Agreement (Alcon Inc)