Common use of Forecasts Clause in Contracts

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 (broken down by Product and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Clinical Forecast”) until Paratek no longer requires any clinical supply of Products. Beginning [* * *] prior to the 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 and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial Forecast”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the quantity of each Product specified in the first [* * *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such period, the “Firm Forecast Period”) and the remaining [* * *] of such forecast shall be a good faith estimate. Except as set forth in the immediately preceding sentence, Paratek shall not be required to order any fixed minimum quantity of either Product, notwithstanding any forecast or prior course of dealing.

Appears in 3 contracts

Samples: Manufacturing Agreement (Paratek Pharmaceuticals, Inc.), Manufacturing and Services Agreement (Paratek Pharmaceuticals, Inc.), Manufacturing and Services Agreement (Paratek Pharmaceuticals, Inc.)

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Forecasts. Within (a) The Xxxx and Corium advisory committee (Committee) will meet at least [* * *] 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 (broken down by Product and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Clinical Forecast”) until Paratek no longer requires any clinical supply of Products. Beginning [* * *] prior to the anticipated launch Launch Date of a Paratek the Product in the Territory and for the remainder purpose of planning a successful Product launch. Corium will prepare a Production Launch Plan for the Product based on Xxxx’x estimated launch quantity and estimated launch date within [*]after receipt of non-binding estimated launch quantities and launch date from Xxxx. Xxxx will place firm purchase orders for the Product far enough in advance to meet Xxxx’x launch requirements based on Corium’s Production Launch Plan. (b) After the Launch Date of the TermProduct within the Territory, Paratek [*] prior to the beginning of each calendar year, Xxxx 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 [*], Xxxx shall submit to CIPAN Corium a forecast of commercial supply of Products that Paratek anticipates ordering from CIPAN during Firm Order for the Product with a shipment date no sooner than [* * *] period (broken down by Product and by month and, if applicable, country in the Territory) following 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 XXXX 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 Xxxx 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 Xxxx’x Firm Order for a calendar quarter be less than Xxxx’x most recent forecast for such calendar quarter pursuant to Section 8.4(b), Xxxx will pay Corium for the costs of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial Forecast”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the quantity of each Product specified in the first [* * *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such period, the “Firm Forecast Period”) and the remaining [* * *] of such forecast Firm Order; provided however that Corium shall be 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 Xxxx for costs of all materials so used for a good faith estimate. Except as set forth in future calendar quarter within [*] after the immediately preceding sentence, Paratek shall not be required to order any fixed minimum quantity end of either Product, notwithstanding any forecast or prior course of dealingsuch future calendar quarter.

Appears in 3 contracts

Samples: 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 DateIn order to assist Miltenyi with its capacity, Paratek shall submit procurement and production planning, Autolus agrees to CIPAN a forecast provide Miltenyi with rolling forecasts of clinical supply of Autolus’ (and its Affiliates’, Subcontractors’, and Licensees’) anticipated requirements for Miltenyi Products that Paratek anticipates ordering from CIPAN during the [* * *] period (broken down by Product and by month andTerm of this Agreement, if applicable, country in accordance with the Territory) following the date provisions of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter this Section 5.1 (each, a “Rolling Clinical 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) until Paratek no longer requires any clinical supply and country-by-country basis. All Forecasts provided by Autolus shall be good faith estimates of ProductsAutolus’ anticipated requirements for Miltenyi Products during the relevant period. Beginning 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) through (c) below shall be subject to Miltenyi’s written consent, which shall not be unreasonably withheld, and which it will endeavor to provide within [* * ***] prior to Business Days of receipt of the anticipated launch initial Forecasts from Autolus. (a) Rolling [***] Forecast; Firm Zone. Within [***] Business Days of a Paratek Product in the Territory Effective Date, and for thereafter by the remainder [***] Business Day of each [***] during the Term, Paratek Autolus (or Autolus’ designee on behalf of Autolus) shall submit to CIPAN a forecast of commercial supply of Products that Paratek anticipates ordering from CIPAN during the [* * ***] period (broken down by Product and by month and, if applicable, country in rolling Forecast of Autolus’ anticipated demand of Miltenyi Products for each of the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling next [* * ***] basis every consecutive Calendar [* * ***], commencing with the Calendar [***] thereafter in which such Forecast is submitted (each, a “Rolling Commercial [***] Forecast”), provided that Paratek shall provide an updated Rolling Commercial Forecast within . The [* * ***] after such Paratek Product receives Regulatory Approval by Forecast shall show demand on a [***] basis, and for the applicable Regulatory Authority in a country in [***] months shall state the Territorydesired dates of Delivery for the forecasted quantities. Paratek shall place purchase orders With respect to any [***] Forecast for at least Miltenyi Products submitted during the quantity of each Product specified in the first Term, [* * ***] of the quantities forecasted for the [***] period of each [***] Forecast (each such Rolling Clinical Forecast or Rolling Commercial Forecast (such period, [***] period shall be referred to as the “Firm Forecast PeriodZone”) shall be binding, and the remaining 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 Section 5.1(d) hereof, a [***] Forecast provided by Autolus shall not be binding upon Autolus. (b) Rolling [***] Forecast. Within [***] Business Days of the Effective Date, and thereafter by the [***] Business Day of each 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 each of the [***] Calendar [***] immediately following the last Calendar [***] of such forecast the [***] Forecast submitted pursuant to clause (a) above (each, a “[***] Forecast”). Each [***] Forecast shall be show demand on a good faith estimate. Except as set forth in the immediately preceding sentence, Paratek shall not be required to order any fixed minimum quantity of either Product, notwithstanding any forecast or prior course of dealing[***] basis.

Appears in 3 contracts

Samples: Supply Agreement (Autolus Therapeutics LTD), Supply Agreement (Autolus Therapeutics LTD), Supply Agreement (Autolus Therapeutics LTD)

Forecasts. Within [* * *] after Commencing on the Effective Date, Paratek OptiNose shall submit to CIPAN a provide CPL each month with non-binding, rolling [***] ([***]) month forecast of clinical supply of Products that Paratek anticipates ordering from CIPAN during the [* * *] period its Product requirements (broken down by Product and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Clinical Forecast”) until Paratek no longer requires any clinical supply of Products. Beginning [* * *] prior to the 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 and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial Forecast”), provided that Paratek . OptiNose shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by be obligated to purchase the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the unit quantity of each Product specified in 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 such calendar month OptiNose will issue a new Rolling Clinical Forecast or Rolling Commercial Forecast (such period, which shall be updated monthly by OptiNose no later than the “Firm Forecast Period”) and the remaining [* * ***] ([***]) business day of such forecast 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 be a good faith estimateparticipate 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. Except Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as set forth in the immediately preceding sentenceboth Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, Paratek for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not be required to order place any fixed minimum quantity 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 Final Approval Date; [***]. The Parties will work collaboratively together regarding planning of either production of initial Product required to build initial launch quantities of Product in anticipation of the Final Approval Date. During the term of this Agreement, CPL shall ensure that, subject to utilization of OptiNose Equipment, it has the Capacity to meet all of OptiNose’s requirements for Product in a timely manner based on the applicable Rolling Forecast under this Agreement and subject to the Product, notwithstanding any forecast ’s standard lead time pursuant to Section 2.5; provided that if new or prior course of dealingadditional OptiNose Equipment is required CPL will inform OptiNose with sufficient lead time for such OptiNose Equipment to be acquired and qualified for use under this Agreement.

Appears in 3 contracts

Samples: Manufacture and Supply Agreement, Manufacture and Supply Agreement (OptiNose, Inc.), Manufacture and Supply Agreement (OptiNose, Inc.)

Forecasts. Within [* 3.1. In order to assist INTERCHEM and UQUIFA in planning the production runs for Omeprazole, SANTARUS shall use its commercially reasonable efforts to provide to UQUIFA and INTERCHEM, at least *** *] after ** of the Effective Datequantities of Omeprazole required by SANTARUS, Paratek *** period. SANTARUS shall submit deliver the first such forecast to CIPAN a forecast of clinical supply of Products that Paratek anticipates ordering from CIPAN during the [* * *] period (broken down by Product INTERCHEM and by month and, if applicable, country in the Territory) UQUIFA as soon as reasonably practicable following the date execution of such this Agreement, and will update the forecast and Paratek shall every *** thereafter. SANTARUS may, at its discretion, update such forecast on more frequently. It is understood that all such forecasts are intended to be SANTARUS' estimates of its purchase requirements and they shall not be binding upon SANTARUS; however, UQUIFA and INTERCHEM shall, at minimum, supply the amounts specified in Section 3.3. 3.2. After the Finished Products have received approval for marketing from a rolling [Regulatory Agency and have been made generally commercially available (hereinafter "COMMERCIAL LAUNCH"), UQUIFA and INTERCHEM shall, within *** days after SANTARUS has provided its *** forecast, notify SANTARUS in writing of any prospective problems it might have with respect to supplying SANTARUS' forecasted order quantities. Upon receipt of such notice, the Parties shall promptly discuss the inability to supply the amounts forecasted by SANTARUS and work in good faith to agree upon revised forecast amounts. *** *] basis every [* ** *] thereafter (each, ** Portions of this page have been omitted pursuant to a “Rolling Clinical Forecast”) until Paratek no longer requires any clinical supply of Productsrequest for Confidential Treatment and filed separately with the Commission. 3.3. Beginning [* * *] prior Subject to the anticipated launch of a Paratek Product lead-time requirements specified in Schedule B, UQUIFA and INTERCHEM shall deliver to SANTARUS' designated facility during any given month, pursuant to Purchase Orders provided under Section 3.4, 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 and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial Forecast”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the quantity of each Product amount specified in the first [* Purchase Order therefor, which amount may be *** *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such period, the “Firm Forecast Period”) and the remaining [* ** *] ** (the "SUPPLY COMMITMENT"). In addition, UQUIFA and INTERCHEM shall use their best efforts to deliver any and all ordered amounts in excess of such forecast the Supply Commitment. 3.4. SANTARUS shall be a good faith estimate. Except as provide to UQUIFA and INTERCHEM Purchase Orders for Omeprazole within the lead times set forth in Schedule B. Within ten (10) business days after the immediately preceding sentencedate that a Purchase Order is submitted (the "ORDER DATE"), Paratek INTERCHEM and UQUIFA shall acknowledge receipt of SANTARUS' Purchase Order and confirm that the amounts of Omeprazole ordered in the Purchase Order, subject to Section 3.3., will be timely supplied. 3.5. UQUIFA and INTERCHEM agree to retain a *** *** . *** of safety stock will be held by INTERCHEM in the United States and *** of safety stock will be held by UQUIFA in Spain. UQUIFA AND INTERCHEM will promptly notify SANTARUS if UQUIFA's manufacturing capacity will be insufficient to fill a Purchase Order submitted by SANTARUS. Such notice will include the expected duration of the shortage and its impact on the supply of Omeprazole to SANTARUS. Such notification shall not operate to relieve UQUIFA or INTERCHEM of their obligations to deliver the ordered amounts of Omeprazole or affect SANTARUS' right to pursue any remedies that may be required available to order any fixed minimum quantity it. UQUIFA and INTERCHEM will use their best efforts to mitigate the impact on SANTARUS of either Product, notwithstanding any forecast shortages or prior course other constrained capacity. The obligations of dealingUQUIFA and INTERCHEM to maintain the safety stock specified herein shall commence as of the Commercial Launch.

Appears in 2 contracts

Samples: Supply Agreement (Santarus Inc), Omeprazole Supply Agreement (Santarus Inc)

Forecasts. Within (i) On [* * ****] after the Effective Date, Paratek shall submit to CIPAN a forecast of clinical supply of Products that Paratek anticipates ordering from CIPAN during and on or about each [****] and [****] between the [* * ****] period and [****], Customer shall provide to Supplier (broken down by Product 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 and, if applicable, country month) of its requirements for each of the Products in the Territoryformat 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) following 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 date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a Rolling Clinical Initial Forecast”) until Paratek no longer requires any clinical supply of Products. Beginning and shall be deemed to be the [* * ****] prior forecast for purposes of [****]. The first six (6) months of each such Forecast provided in [****] shall constitute a binding obligation to purchase the specified Products (the “Binding Forecast”) to the anticipated launch extent that the specified Product being ordered is within production lead times. The second six (6) months of a Paratek Product in each such Binding Forecast shall be non-binding (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 and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a Rolling Commercial 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, provided dates and delivery schedule for such purchases. Supplier shall accept each Purchase Order that Paratek 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 ordered and sold at the relevant price indicated by such 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. (ii) Beginning on [****] and on or about each subsequent [****] and [****] during the Term of this Agreement, Customer shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval to Supplier (by email to the applicable Regulatory Authority in attention of Supplier’s Sales Administrator and Director of Manufacturing, with a country copy to Business Leader, Sequencing) 12-month forecasts (by month) of its requirements for each of the Products in the Territory. Paratek shall place purchase orders for at least the quantity of format reasonably requested by Supplier and each Product specified in the first [* * *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such period, the “Firm Forecast Period”) and the remaining [* * *] of such forecast shall constitute a binding obligation to purchase the specified amount and type of Products (the “Binding Forecast”) to the extent that the specified Product being ordered is within production lead times. For clarity, the Binding Forecast provided on or about the A&R Effective Date shall be 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 recipient email addresses from time to time (by email to the attention of Customer’s VP of Operations with a good faith estimatecopy 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. Except as set forth in Each Binding Forecast required by this Section 2.a(ii) will be accompanied by a purchase order (a “Purchase Order”) for any Products required for the immediately preceding sentencefirst six (6) months of such Binding Forecast, Paratek shall not be including any Instruments required to order any fixed minimum quantity be purchased by Customer during such six (6) month period in accordance with Section 1.a(iv). The Purchase Orders shall describe the terms, dates and delivery schedule for such purchases in accordance with the terms of either Product, notwithstanding any forecast or prior course this Agreement. Supplier shall accept each Purchase Order that complies with a Binding Forecast and the other terms of dealingthis Agreement. [****].

Appears in 2 contracts

Samples: Supply Agreement (Raindance Technologies Inc), Supply Agreement (Raindance Technologies Inc)

Forecasts. Within [* * *] after (i) With respect to MTO Products: By the Effective Datefifth (5th) Business Day of each calendar month during the Term, Paratek Customer (or Customer’s designee on behalf of Customer) shall submit to CIPAN a rolling forecast of clinical supply of Products that Paratek anticipates ordering from CIPAN during the [* * *] period (broken down by Product of Customer’s anticipated demand of such Product for the next twenty-four (24) consecutive months, commencing with the month in which such forecast is sent (each, an “MTO Forecast”). The MTO Forecast shall show demand on a monthly basis, and for the first three months shall state the dates of delivery for such Product. Without limiting Section 2.4(b) each MTO Forecast, including the required delivery dates, is non-binding. In the event that Manufacturer has failed to receive an updated MTO Forecast by month the fifth (5th) Business Day of any calendar month, Manufacturer shall notify Customer of such failure and, if applicableCustomer has not responded with an updated MTO Forecast by the tenth (10th) Business Day of such month, country the most recent MTO Forecast shall be regarded as current. (ii) With respect to VMR Products: Customer shall provide Manufacturer access to Customer’s demand management system (e.g., Manugistics) for the purpose of managing supply to, and determining the forecasts for, Customer’s markets according to Planned Arrivals (as such term is used therein) calculated by the system in accordance with replenishment parameters agreed in writing between Customer and Manufacturer in the Territoryapplicable Product Addendum and in the Supply Chain Agreement (including as may be listed in Exhibit D and as such parameters may be provided, updated and revised by mutual written agreement of the Parties from time to time) following (the date of “Supply Chain Agreement”, and each such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (eachforecast, a “Rolling Clinical Forecast”) until Paratek no longer requires any clinical supply of Products. Beginning [* * *] prior to the 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 and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial VMR Forecast”), provided that Paratek and Manufacturer shall provide an updated Rolling Commercial Forecast within [* * *] after schedule production of such Paratek Product receives Regulatory Approval by and delivery of such Product to Customer in accordance with such derived VMR Forecasts and the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the quantity of each Product specified in the first [* * *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such period, the “Firm Forecast Period”) and the remaining [* * *] of such forecast shall be a good faith estimate. Except as lead times set forth in the immediately preceding sentenceapplicable Product Addendum. Manufacturer shall confirm all such Product shipments via the replenishment planning system according to the Supply Chain Agreement parameters and the parameters in the applicable Product Addendum. (iii) With respect to any Product designated as a “Biological” in the applicable Product Addendum, Paratek the first six (6) month period of each Forecast with respect thereto shall be binding, and the corresponding portion of each subsequent Forecast shall be consistent with such period. (iv) Without limiting the foregoing, the Parties agree that certain Supply Chain Agreement parameters and replenishment parameters in the Product Addendum may not be required available and included in Exhibit D or such Product Addendum as of the Effective Date and shall be included therein prior to order any fixed minimum quantity the IPO Closing by written approval of either Producteach Party, notwithstanding any forecast or prior course of dealingsuch approval not to be unreasonably withheld.

Appears in 2 contracts

Samples: Master Manufacturing and Supply Agreement, Master Manufacturing and Supply Agreement (Zoetis Inc.)

Forecasts. Within [* * *] after During the Effective Dateterm of this Agreement, Paratek Buyer shall submit use its best efforts to CIPAN update, on a quarterly basis, a continuous usage forecast to assist Seller in maintaining an orderly production flow for the purpose of clinical supply 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 Products that Paratek anticipates ordering from CIPAN during this Agreement upon payment of cancellation charges which shall include all costs incurred or committed for, and a reasonable profit on such costs, unless (i) such costs are otherwise recoverable through the [* * *] period sale of the product on a timely basis or (broken down ii) Buyer's cancellation is due to Motorola's failure to meet its forecasted delivery schedule resulting in cancellation of Product orders by Product and by month and, if applicable, country in the TerritoryBuyer's own customer. Payment of cancellation charges shall be due within thirty (30) following days of the date of invoice. Seller agrees to divert completed material and work in process from canceled orders to other requirements wherever possible in order to minimize cancellation charges. 4. DELIVERY AND PAYMENT (a) All deliveries are FOB Motorola's plant. Each such forecast delivery will be separately invoiced and Paratek payment from Buyer shall update such forecast on a rolling [* * *] basis every [* * *] thereafter be due thirty (each, a “Rolling Clinical Forecast”30) until Paratek no longer requires any clinical supply of Productsdays from the date thereof without regard to other deliveries. Beginning [* * *] prior DELIVERY DATES ARE BEST ESTIMATES ONLY. (b) Title to the anticipated launch Products sold shall pass to Buyer at the FOB point. Buyer hereby grants to MOTOROLA a security interest and lien upon all of a Paratek Product in the Territory and for the remainder Buyer's now existing or hereafter acquired inventory of the Termproducts, Paratek shall submit to CIPAN a forecast and all of commercial supply of Products that Paratek anticipates ordering from CIPAN during the [* * *] period (broken down by Product and by month andBuyer's account, if applicablechattel paper, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (eachinstruments, a “Rolling Commercial Forecast”)contract rights, provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the quantity of each Product specified in the first [* * *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such periodgeneral intangibles, the “Firm Forecast Period”) accounts receivable and the remaining [* * *] proceeds 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 forecast shall be a good faith estimatesecurity interest and lien upon request. 5. Except as set forth in the immediately preceding sentence, Paratek FORCE MAJEURE MOTOROLA shall not be required liable for any delay or failure to perform due to any cause beyond its reasonable control. Causes include but are not limited to strikes, 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 time lost because of any excusable delay. To the extent that MOTOROLA is unable to manufacture and deliver the annual commitment, it shall be reduced on a pro rata basis. In the event MOTOROLA is unable to wholly or partially perform for a period greater than forty-five (45) days because of any cause beyond its reasonable control, either party may terminate any delayed order without any fixed minimum quantity of either Product, notwithstanding any forecast or prior course of dealingliability.

Appears in 2 contracts

Samples: Sales Contracts (Transcrypt International Inc), Sales Contracts (Transcrypt International Inc)

Forecasts. Within [A. Upon execution of the Agreement, BMPI shall provide Chiron with a non-binding, long-term, written forecast of the quantities of Product that BMPI will require during each of the following five (5) calendar years. BMPI shall update this forecast on or before July 1 of each year thereafter, stating its requirements for the shorter of (i) the (5) following calendar years or (ii) the remainder of the term of the Agreement. B. Upon execution of the Agreement, BMPI shall provide Chiron with a rolling, 15-month, monthly forecast (the "FORECAST") of the number of grams of Product that BMPI will require in each month of the 15-month period (the "FORECASTED REQUIREMENTS"), and the requested delivery date(s). ** C. The first six months of the Forecast shall be binding upon BMPI (the "BINDING REQUIREMENTS") and may not be changed without Chiron's prior written consent. The seventh through ninth months of the Forecast shall be binding on BMPI to the extent that BMPI may not increase or decrease the monthly requirements for Product by more than **), without Chiron's prior written consent. (i) At least ** * *] after days prior to the Effective Datedate on which BMPI would like Product delivered, Paratek BMPI shall submit to CIPAN Chiron a forecast of clinical supply of Products that Paratek anticipates ordering from CIPAN during binding purchase order covering the [* * *] period (broken down by Product and by month Binding Requirements and, if applicabledesired, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [any, additional Product ** * *] basis every [* * *] thereafter that BMPI would like to receive at that time (each, a “Rolling Clinical Forecast”"PURCHASE ORDER"). The Purchase Order shall specify the requested dates of and locations of delivery of the ordered Product. ** Chiron will acknowledge receipt of all Purchase Orders received hereunder within ** days. (ii) until Paratek no longer requires any clinical supply of Products. Beginning [* * *] prior Chiron will fill each properly-submitted Purchase Order, to the anticipated launch of a Paratek Product in the Territory and for the remainder extent of the TermBinding Requirement, 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 and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial Forecast”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority delivery date requested therein or another date mutually agreed upon by the parties, in a country writing. Chiron will use commercially reasonable efforts to supply any additional Product ordered but does not guarantee that such Product will be supplied. All additional Product so supplied will be charged at the price provided in the Territory. Paratek shall place purchase orders for at least the quantity of each Product specified in the first [* * Section 7.1, below, plus *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such period, the “Firm Forecast Period”) and the remaining [* * *] of such forecast shall be a good faith estimate. Except as set forth in the immediately preceding sentence, Paratek shall not be required to order any fixed minimum quantity of either Product, notwithstanding any forecast or prior course of dealing.

Appears in 2 contracts

Samples: Manufacturing Agreement (Biomimetic Therapeutics, Inc.), Manufacturing Agreement (Biomimetic Therapeutics, Inc.)

Forecasts. Within (a) Prior to the 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 manufacturing capacity required for commercial manufacturing of Product. 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 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 [* * ***] after basis, Customer shall provide Corden with a rolling [***]-month forecast (“Rolling Forecast”) indicating Customer’ expected delivery of Product for the Effective Datenext [***] (i.e., Paratek [***]), in full batch sizes. The first [***] months (i.e., the first [***] ) of the Rolling Forecast (i.e., [***]) shall submit to CIPAN a forecast of clinical supply of Products that Paratek anticipates ordering from CIPAN during be considered binding for both Parties under this Section 5 (“Binding Forecast”), and the second [* * ***] period (broken down by 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 and by month andin excess of the amount set forth in the previous Binding Forecast, if applicableany, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Clinical Forecast”) until Paratek no longer requires any clinical supply of Products. Beginning [* * *] prior to the anticipated launch of a Paratek Product in the Territory and for assuming that the remainder of the TermRolling Forecast will become binding in time as contemplated by this Agreement. In the event that, Paratek shall submit to CIPAN a forecast upon receipt of commercial supply of Products that Paratek anticipates ordering from CIPAN during the [* * *] period (broken down by Product and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial Forecast”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Forecast, Corden anticipates that it shall not be able to manufacture or otherwise supply Customer’ requirements for Product receives Regulatory Approval by in excess of the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the quantity of each Product specified in the first [* * *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such period, the “Firm Forecast Period”) and the remaining [* * *] of such forecast shall be a good faith estimate. Except as amount set forth in the immediately preceding sentenceprevious Binding Forecast, Paratek Corden shall inform Customer in writing within [***] Business Days after Xxxxxx’s receipt of said updated Rolling Forecast, and 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 required able to order manufacture or otherwise supply for Customer. For the avoidance of doubt, Xxxxxx will not be obliged to manufacture any fixed minimum quantity portion of either Productthe initial Binding Forecast that requires a capital investment in the Production Facility, notwithstanding unless otherwise agreed by Corden. (d) 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 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 quarter by more than [***]percent ([***]%) over the previous Non-Binding Forecast. The Parties agree to discuss as soon as practicable any such overage request, provided Xxxxxx will use commercially reasonable efforts to fulfill such overage and 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 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 prior course as specified in the Product Addendum for analytical testing and release of dealingsuch Customer Materials by Corden.

Appears in 1 contract

Samples: Commercial Supply Agreement (Acadia Pharmaceuticals Inc)

Forecasts. Within [ORPHAN shall provide Catalytica with forecasts of ORPHAN’S anticipated [ * ] requirements of the Product for distribution and sale in the United States commencing with the [ * *] 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 (broken down by Product that begins at the time of FDA approval of the Product. Such forecast will be provided [ * ] in advance of anticipated FDA approval of the NDA and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek ORPHAN shall update such [ * ] forecast on a rolling [[ * * *] basis every [* * *] thereafter (eachthereafter. Once FDA approval of the Product is received, a “Rolling Clinical Forecast”) until Paratek no longer requires any clinical supply of Products. Beginning [* * *] ORPHAN will provide Catalytica, prior to the beginning of each [ * ], with forecasts of its anticipated launch requirements of a Paratek the Product in the Territory and for the remainder following [ * ] and the forecast for the first [ * ] shall be firm and binding on ORPHAN. 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 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 and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial Forecast”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the quantity of each the Product specified 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 first [Product outside the United States, ORPHAN shall supplement its [ * ] forecast accordingly to indicate the additional requirements of the Product for such purposes. [ * *] = 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. (c) If Catalytica manufactures the Product with a lead time of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such periodmore than [ * ], the “Firm Forecast Period”) and the remaining [* * *] of such forecast shall be a good faith estimate. Except as set forth in the immediately preceding sentence, Paratek ORPHAN shall not be required to order pay any fixed minimum quantity additional storage, or pay for the Product sooner than as set forth in Section 7.7 nor shall any advance manufacture lead to a violation of either Product, notwithstanding any forecast or prior course the warranty of dealingexpiration date set forth in Section 8.1.

Appears in 1 contract

Samples: Supply Agreement (Jazz Pharmaceuticals Inc)

Forecasts. Within 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 [* * ***] after the Effective Date, Paratek shall submit to CIPAN a forecast of clinical supply its Product requirements (“Rolling Forecast”). OptiNose shall be obligated to purchase the unit quantity of Products that Paratek anticipates ordering from CIPAN during for the [* * ***] of any Rolling Forecast that was requested in the Rolling Forecast for that [***] period (broken down by Product and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Clinical Forecast”) until Paratek no longer requires any clinical supply of Products. Beginning [* * *] prior to the 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 and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial ForecastBinding Period”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by . During the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the quantity first business week of each Product specified in calendar month, OptiNose will issue a new Rolling Forecast which shall be updated monthly by OptiNose no later than the first fifth (5th) business day of each calendar month with the Binding Period updated with each Rolling Forecast to include the new [* * ***] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such period, the “Firm Forecast Period”) and the remaining 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 such forecast shall be a good faith estimate. Except as set forth in the immediately preceding sentencethis Agreement, Paratek 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 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 fixed minimum quantity other costs agreed to by the Parties. The Parties will work collaboratively together regarding planning of either 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 in a timely manner based on the applicable Rolling Forecast under this Agreement and subject to the Product’s standard lead time pursuant to Section 2.5; provided that if new or additional OptiNose Equipment is required, notwithstanding any forecast or prior course of dealingHikma will inform OptiNose with sufficient lead time for such OptiNose Equipment to be acquired and qualified for use under this Agreement.

Appears in 1 contract

Samples: Manufacture and Supply Agreement (OptiNose, Inc.)

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Forecasts. Within 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 (or country of manufacture). 4.3 The BUYER's good faith forecast for its expected purchases of PRODUCTS for the twelve month period beginning from April 1, 2000 is [* * *] Beginning [*] after the Effective Datefirst delivery order, Paratek the BUYER shall submit then deliver to CIPAN a forecast of clinical supply of Products that Paratek anticipates ordering from CIPAN during the [* * *] period (broken down by Product and by month and, if applicable, country in * 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 Territory) following the date of such COMPANY a revised forecast and Paratek shall update such forecast at least once per [*] on a rolling [* * *] basis every [* * *] thereafter basis. 4.4 Forecasts provided under the paragraph (each4.3) above are for planning purposes only and do not constitute an order commitment or obligation on the part of the BUYER or the COMPANY. To the extent reasonably possible, a “Rolling Clinical Forecast”) until Paratek no longer requires however, the BUYER agrees to place orders consistent with such forecasts. The volume ordered by the BUYER in any clinical supply of Products. Beginning [* * *] prior to given month may be increased or decreased from the anticipated launch of a Paratek Product volume included 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 and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek there shall update be no fee associated with such variance. If the BUYER submits any forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial Forecast”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority or places any order in a country in the Territory. Paratek shall place purchase orders for at least which the quantity of each Product specified PRODUCTS forecasted or ordered for any month deviates by more than [*] from the forecasted quantity of PRODUCTS for such [*] contained in the first [* * *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such periodmost 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 “Firm Forecast Period”) 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 as altered requirements and the remaining [* * *] of such forecast shall be a good faith estimate. Except as set forth difficulties in the immediately preceding sentence, Paratek shall not be required to order any fixed minimum quantity of either Product, notwithstanding any forecast or prior course of dealingproductions.

Appears in 1 contract

Samples: Sales Agreement (Utstarcom Inc)

Forecasts. Within [* * *] a. As soon as practicable after the Effective Date, Paratek shall submit Date and at least [*] days prior to CIPAN a forecast of clinical supply of Products that Paratek anticipates ordering from CIPAN during the [* * *] period of each calendar month thereafter, Amgen will provide Insulet with eighteen (broken down by Product 18) month rolling * Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [*]. A complete version of this exhibit has been filed separately with the Securities and by month and, if applicable, country in the Territory) following the date Exchange Commission. forecasts of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter Amgen’s anticipated monthly requirements for Custom Insulet Devices (each, a “Rolling Clinical Forecast”) until Paratek no longer requires any clinical supply of Products. Beginning [* * *] prior to the 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 and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial Forecast”), provided that Paratek which Forecasts shall provide an updated Rolling Commercial Forecast within commence on the month immediately following delivery of such forecast. The [* * *] after such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the quantity of each Product specified in the first [* * *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast shall be binding on Amgen (such period, the “Firm Forecast PeriodBinding Portion”) and Amgen shall issue Purchase Orders for all amounts included in the remaining Binding Portion of such Forecasts. b. Except as mutually agreed in writing by the Parties, for each Forecast following the initial Forecast provided by Amgen, the quantity of Customized Insulet Device forecast (i) for the [* * *] months of such Forecast shall not vary from the amounts forecasted for such months in the most recent previously delivered Forecast, (ii) the amounts forecasted for the [*] of such forecast Forecast shall be a good faith estimate. Except as set forth not exceed [*] percent ([*]%) of the amounts forecasted for such month in the immediately preceding sentence, Paratek most recent previously delivered Forecast and (iii) the amounts forecasted for the [*] months of such Forecast 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 required adjusted pursuant to order 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 fixed minimum quantity portions of either Productsuch Forecasts, notwithstanding any forecast or prior course and (c) with the exception of dealingthe Binding Portion of the Forecasts, Insulet does not guarantee its ability to meet the requirements of such Forecasts.

Appears in 1 contract

Samples: Supply Agreement (Insulet Corp)

Forecasts. (a) Within [* * *] thirty (30) days after the Effective DateDate of this Agreement, Paratek Xxxxx & Nephew shall submit deliver to CIPAN ArthroCare a good faith, monthly rolling forecast of clinical supply its quantity requirements and shipping dates for each category (i.e., SKU) of Products that Paratek anticipates ordering from CIPAN during ArthroCare Manufactured Product for the [* * *] period (broken down by Product and by commencing with the month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Clinical Forecast”) until Paratek no longer requires any clinical supply of Products. Beginning [* * *] prior to the anticipated launch of a Paratek Product in the Territory and for the remainder of the Term, Paratek shall submit to CIPAN a forecast Effective Date of commercial supply of Products that Paratek anticipates ordering from CIPAN during the [* * *] period (broken down by Product and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial Forecast”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority in a country in the Territorythis Agreement. Paratek shall place purchase orders for at least the quantity of each Product specified in the The first [* * *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such period, the “Firm Forecast Period”) and the remaining [* * *] of such forecast shall be binding forecasts and deemed firm orders for the number of each category of ArthroCare Manufactured Product specified in such forecasts, and the forecast for the remaining [*] shall be non-binding. Thereafter, Xxxxx & Nephew shall submit to ArthroCare at or prior to the end of each month a good faith estimateforecast of its quantity requirements and shipping dates for each such category of ArthroCare Manufactured Product for the following [*] period, so that estimates for a rolling [*] period are always provided. Except as set forth Subject to Section 3.2(a), the [*] of each such [*] forecast shall be binding forecasts and deemed firm orders for the number of ArthroCare Manufactured Products specified in such forecasts, and the forecast for the remaining [*] shall be non-binding. If Xxxxx & Nephew provides ArthroCare with a written request for a quantity increase in any firm order already submitted to ArthroCare or included in a binding forecast, ArthroCare and Xxxxx & Nephew will discuss in good faith the additional amount, if any, that ArthroCare is willing and able to supply to Xxxxx & Nephew consistent with ArthroCare’s other obligations, and Xxxxx & Nephew will adjust its order accordingly. In no event is ArthroCare obligated to supply any such additional amounts of such Products, but will use its reasonable commercial efforts to do so. (b) If a required forecast for a particular month is not timely submitted for a ArthroCare Manufactured Product, the immediately preceding sentenceforecast for such month shall become the new forecast for such month; if there is no preceding forecast for such month, Paratek the forecast for the next preceding month shall not be required become the forecast for such month. (c) Xxxxx & Nephew’s forecasts and orders shall reflect its good faith expectations of customer demand and reasonable inventory and safety stock requirements, and Xxxxx & Nephew shall act in a commercially reasonable manner to order any fixed minimum schedule orders to avoid creating over or under capacity problems for ArthroCare. ArthroCare shall fulfill Xxxxx & Nephew’s orders, as provided in Section 3.2(a), and shall use good faith and reasonable commercial efforts to accommodate changes in Xxxxx & Nephew’s requests for delivery dates, quantity of either Product, notwithstanding any forecast or prior course of dealingand other supply issues relating to ArthroCare Manufactured Products.

Appears in 1 contract

Samples: Supply and Distribution Agreement (Arthrocare Corp)

Forecasts. Within (a) The Xxxx and Corium advisory committee (Committee) will meet at least [* * *] 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 (broken down by Product and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Clinical Forecast”) until Paratek no longer requires any clinical supply of Products. Beginning [* * *] prior to the anticipated launch Launch Date of a Paratek the Product in the Territory and for the remainder purpose of planning a successful Product launch. Corium will prepare a Production Launch Plan for the Product based on Xxxx’x estimated launch quantity and estimated launch date within [*]after receipt of non-binding estimated launch quantities and launch date from Xxxx. Xxxx will place firm purchase orders for the Product far enough in advance to meet Xxxx’x launch requirements based on Corium’s Production Launch Plan. (b) After the Launch Date of the TermProduct within the Territory, Paratek [*] prior to the beginning of each calendar year, Xxxx 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 [*], Xxxx shall submit to CIPAN Corium a forecast of commercial supply of Products that Paratek anticipates ordering from CIPAN during Firm Order for the Product with a shipment date no sooner than [* * *] period (broken down by Product and by month and, if applicable, country in the Territory) following 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 XXXX 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 Xxxx 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 Xxxx’x Firm Order for a calendar quarter be less than Xxxx’x most recent forecast for such calendar quarter pursuant to Section 8.4(b), Xxxx will pay Corium for the costs of any unused quantities of such materials ordered for such calendar quarter in reliance on such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial Forecast”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the quantity of each Product specified in the first [* * *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such period, the “Firm Forecast Period”) and the remaining [* * *] of such forecast Firm Order; provided however that Corium shall be 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 Xxxx for costs of all materials so used for a good faith estimate. Except as set forth in future calendar quarter within [*] after the immediately preceding sentence, Paratek shall not be required to order any fixed minimum quantity end of either Product, notwithstanding any forecast or prior course of dealingsuch future calendar quarter.

Appears in 1 contract

Samples: Development, Manufacturing and Commercialization Agreement

Forecasts. Within [During the term of this Agreement, PCYC shall provide to DOTTIKON [ *** * *] after the Effective Date, Paratek shall submit to CIPAN a written rolling forecast of clinical supply the quantities 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 that Paratek anticipates ordering from CIPAN to be delivered during [ *** ] Each such forecast shall have the [* * *] period (broken down by Product and by month andfollowing effect, if applicable, country except as otherwise set forth in the Territory) following applicable Product Appendix: [ *** ] [ *** ]; and [ *** ]; and [ *** ] Purchase Orders. All purchases of Products shall be made pursuant to Purchase Orders which shall be delivered to the Facility, or such other location as agreed to in writing by the Parties, at least [ *** ] in advance of the date of shipment specified in such forecast and Paratek shall update Purchase Order, or to such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Clinical Forecast”) until Paratek no longer requires any clinical supply of Products. Beginning [* * *] prior to the 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 [* * *] other location and/or within such other time period (broken down by Product and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial Forecast”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the quantity of each Product as may be specified in the first [* * *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such period, the “Firm Forecast Period”) and the remaining [* * *] of such forecast applicable Product Appendix. DOTTIKON shall be a good faith estimate. Except ship all Products as set forth in Section 4.5 by the immediately preceding sentence, Paratek date and in the quantities specified in the applicable Purchase Order. 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 be required require DOTTIKON to order any fixed minimum quantity Manufacture a Product in quantities in excess of either DOTTIKON's Capacity for such Product, notwithstanding and shall use its best efforts to accept any forecast Purchase Order in excess thereof. Any Purchase Order (or prior course portion thereof) for which PCYC has not received a written rejection from DOTTIKON within [ *** ] of dealingDOTTIKON's receipt of such Purchase Order 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 intended Manufacturing campaign for fulfilling such Purchase Order. To the extent that the terms of a Purchase Order are inconsistent with the terms of this Agreement, this Agreement shall control. 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 submitted by facsimile to the attention of the contact person or department specified in the applicable Product Appendix, and confirmed by mail, unless otherwise agreed in the applicable Product Appendix.

Appears in 1 contract

Samples: Supply Agreement (Pharmacyclics Inc)

Forecasts. Within [* * *] after NICE shall give Contractor a written forecast of the Products, by type, quantity and expected Due Date (the "FORECAST") as follows: A Forecast shall be a rolling forecast for the current Quarter and the two (2) consecutive Quarters, detailed by week. Upon the Effective Date, Paratek NICE shall submit to CIPAN deliver a forecast Forecast for the period commencing on the expected completion of clinical supply of Products that Paratek anticipates ordering from CIPAN during the [* * *] period (broken down by Product and by month andRelocation Phase for the first Product, if applicable, country in for the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Clinical Forecast”) until Paratek no longer requires any clinical supply of Products. Beginning [* * *] prior to the anticipated launch of a Paratek Product in the Territory current Quarter 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 next coming two Quarters and so on thereafter during the [* * *] period (broken down term of this Agreement. The Forecast may be updated by Product and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast NICE on a rolling [* * *] basis every [* * *] thereafter weekly basis, or more frequently (eachat NICE' discretion). A Forecast will not be deemed to constitute a binding purchase order with respect to Products (as opposed to components and sub-assemblies, a “Rolling Commercial Forecast”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the quantity of each Product specified in the first [* * *] of each such Rolling Clinical Forecast or Rolling Commercial Forecast (such period, the “Firm Forecast Period”) and the remaining [* * *] of such forecast shall be a good faith estimate. Except as set forth in Sections 3.4, 16 and 17.5 of this Agreement). Contractor will manufacture the immediately preceding sentencequantities of Products only according to specific orders and the Production Lead Time. The Parties' responsibilities and undertakings arising from NICE' Forecast shall be according to APPENDIX C as amended from time to time according to the provisions of this Agreement. Liability reports will be submitted by Contractor on the 1st of each calendar month and will need to be approved by NICE. It is clarified for the avoidance of doubt, Paratek that in any event, any and all purchase obligations of NICE with respect to Products (as opposed to components and sub-assemblies) are limited in any given time during the term of this Agreement, to the PO's only. Contractor (with NICE' participation) will implement, at its own expense, a full process of Demand Flow Technology, including: (I) Product Synchronization; (II) Sequence of Events; (III) Mix Model; (IV) Demand of Capacity & Take Time; (V) Operations grouping; (VI) Line Design & Balancing. This process will help to determine the Sub Assembly Lead Time and the Production Lead Time. It is clarified that any change in the Production Lead Time detailed in this Agreement shall not be required to order require NICE' prior written approval; any fixed minimum quantity change in the Sub Assembly Lead Time detailed in this Agreement as a result of either Productwhich the maximum Sub Assembly Lead Time for the relevant sub-assembly exceeds 30 Days, notwithstanding any forecast or shall require NICE' prior course of dealingwritten approval.

Appears in 1 contract

Samples: Manufacturing Outsourcing Agreement (Nice Systems LTD)

Forecasts. Within [ORPHAN shall provide Supplier with forecasts of ORPHAN’S anticipated [ * ] requirements of the Drug for distribution and sale in the United States commencing with the [ * *] 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 (broken down by Product that begins at the time of an FDA approval. Such forecast will be provided [ * ] in advance of anticipated FDA approval of the NDA and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek ORPHAN shall update such [ * ] forecast on a rolling [[ * * *] basis every [* * *] thereafter (eachthereafter. Once FDA approval of the Drug is received, a “Rolling Clinical Forecast”) until Paratek no longer requires any clinical supply of Products. Beginning [* * *] ORPHAN will provide Supplier, prior to the beginning of each [ * ], with forecasts of its anticipated launch requirements of a Paratek Product in the Territory and Drug for the remainder following [ * ]. 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 to Supplier pursuant to this Section 6.1 are for planning purposes only 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 Term, Paratek Drug for ORPHAN during [ * ]. (b) Supplier shall submit [ * ] manufacture during any [ * ] up to CIPAN a forecast [ * ] of commercial supply of Products that Paratek anticipates ordering from CIPAN during the [* * *] period (broken down by Product and by month and, if applicable, country in the Territory) following the date of such forecast and Paratek shall update such forecast on a rolling [* * *] basis every [* * *] thereafter (each, a “Rolling Commercial Forecast”), provided that Paratek shall provide an updated Rolling Commercial Forecast within [* * *] after such Paratek Product receives Regulatory Approval by the applicable Regulatory Authority in a country in the Territory. Paratek shall place purchase orders for at least the quantity of each Product specified 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) When and as ORPHAN proposes to commence its distribution and sale of the first [Drug outside the United States, ORPHAN shall supplement its [ * ] forecast accordingly to indicate the additional requirements of the Drug for such purposes. (d) Supplier acknowledges that accurate forecasts of requirements are inherently difficult for a new pharmaceutical product. ORPHAN [ * *]. Accordingly, if [ * ], it will [ * ] ninety (90) days [ * ], in which case ORPHAN [ * ]. The [ * ] delivery of each [ * ] are that during such Rolling Clinical Forecast or Rolling Commercial Forecast [ * ] (such period, the “Firm Forecast Period”i) and the remaining [* * *] of such forecast ORPHAN shall be a good faith estimate. Except as required to purchase [ * ] the amount set forth in the immediately preceding sentence[ * ] and (ii) Supplier shall be required to manufacture [ * ] such amount. If ORPHAN does not deliver a [ * ], Paratek 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 [ * ], ORPHAN shall not be required to order pay any fixed minimum quantity additional storage, or pay for the Drug sooner than as set forth in Section 7.5 nor shall any advance manufacture lead to a violation of either Product, notwithstanding any forecast or prior course the warranty of dealingexpiration date set forth in Section 8.1.

Appears in 1 contract

Samples: Development and Supply Agreement (Jazz Pharmaceuticals Inc)

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