Common use of Forecasts Clause in Contracts

Forecasts. Commencing on the Effective Date, OptiNose shall provide CPL each month with non-binding, rolling [***] ([***]) month forecast of its Product requirements (“Rolling Forecast”). OptiNose shall be obligated to purchase the unit quantity of Products for the first [***] months of any Rolling Forecast that was requested in the Rolling Forecast for that [***] ([***]) month period (a “Binding Period”). During the [***] of each calendar month OptiNose will issue a new Rolling Forecast which shall be updated monthly by OptiNose no later than the [***] ([***]) business day of each calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] month of the going forward [***] month Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not be required to place any Purchase Order for quantities that otherwise would be applicable for any Binding Period, and OptiNose may, in its sole discretion, cancel or modify any Purchase Order placed prior to the Final Approval Date; [***]. The Parties will work collaboratively together regarding planning of 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’s standard lead time pursuant to Section 2.5; provided that if new or additional 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

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

Forecasts. Commencing (a) The ▇▇▇▇ and Corium advisory committee (Committee) will meet at least [*] prior to the Launch Date of the Product for the purpose of planning a successful Product launch. Corium will prepare a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity and estimated launch date within [*]after receipt of non-binding estimated launch quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Effective DateProduct far enough in advance to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch Plan. (b) After the Launch Date of the Product within the Territory, OptiNose [*] prior to the beginning of each calendar year, ▇▇▇▇ shall provide CPL 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 month with [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding, rolling binding and shall be used by Corium for planning purposes only. (c) [*] prior to [*], ▇▇▇▇ shall submit to Corium a Firm Order for the Product with a shipment date no sooner than [*] (from the date of the Firm Order. Corium shall accept or reject a Firm Order within [***]) month forecast of its Product requirements (“Rolling Forecast”)receipt. OptiNose Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within such [*] period, such Firm Order shall be obligated deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the unit quantity Product. No change may be made in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Products Corium (such consent not to be unreasonably withheld). (d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b), ▇▇▇▇ will pay Corium for the first [***] months costs of any Rolling Forecast that was requested unused quantities of such materials ordered for such calendar quarter in the Rolling Forecast for that reliance on such forecast within [***] ([***]) month period (a “Binding Period”). During the [***] of each such Firm Order; provided however that Corium shall use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar month OptiNose will issue quarters, and shall reimburse or credit ▇▇▇▇ for costs of all materials so used for a new Rolling Forecast which shall be updated monthly by OptiNose no later than the future calendar quarter within [***] ([***]) business day after the end of each such future calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] month of the going forward [***] month Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not be required to place any Purchase Order for quantities that otherwise would be applicable for any Binding Period, and OptiNose may, in its sole discretion, cancel or modify any Purchase Order placed prior to the Final Approval Date; [***]. The Parties will work collaboratively together regarding planning of 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’s standard lead time pursuant to Section 2.5; provided that if new or additional 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 Agreementquarter.

Appears in 3 contracts

Sources: Development, Manufacturing and Commercialization Agreement (Corium International, Inc.), Development, Manufacturing and Commercialization Agreement (Corium International, Inc.), Development, Manufacturing and Commercialization Agreement (Corium International, Inc.)

Forecasts. Commencing on Within [* * *] after the Effective Date, OptiNose Paratek shall provide CPL each 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 with non-bindingand, 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 [* * ***]) month ] 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 its commercial supply of Products that Paratek anticipates ordering from CIPAN during the [* * *] period (broken down by Product requirements 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. OptiNose Paratek shall be obligated to place purchase orders for at least the unit quantity of Products for each Product specified in the first [***] months of any Rolling Forecast that was requested in the Rolling Forecast for that [***] ([***]) month period (a “Binding Period”). During the [*** * *] of each calendar month OptiNose will issue a new such Rolling Clinical Forecast which or Rolling Commercial Forecast (such period, the “Firm Forecast Period”) and the remaining [* * *] of such forecast shall be updated monthly by OptiNose no later than a good faith estimate. Except as set forth in the [***] ([***]) business day of each calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] month of the going forward [***] month Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreementimmediately preceding sentence, for Rolling Forecasts issued prior to Final Approval Date, OptiNose Paratek shall not be required to place order any Purchase Order for quantities that otherwise would be applicable for fixed minimum quantity of either Product, notwithstanding any Binding Period, and OptiNose may, in its sole discretion, cancel forecast or modify any Purchase Order placed prior to the Final Approval Date; [***]. The Parties will work collaboratively together regarding planning course of 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’s standard lead time pursuant to Section 2.5; provided that if new or additional 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 Agreementdealing.

Appears in 3 contracts

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

Forecasts. Commencing In order to assist Miltenyi with its capacity, procurement and production planning, Autolus agrees to provide Miltenyi with rolling forecasts of Autolus’ (and its Affiliates’, Subcontractors’, and Licensees’) anticipated requirements for Miltenyi Products during the Term of this Agreement, in accordance with the provisions of this Section 5.1 (each, a “Forecast”). All of the Forecasts provided under this Agreement shall break down the demand of Miltenyi Products on a product-by-product (expressed in number of units or lots) and country-by-country basis. All Forecasts provided by Autolus shall be good faith estimates of Autolus’ anticipated requirements for Miltenyi Products during the Effective Daterelevant period. Autolus agrees to use Commercially Reasonable Efforts in preparing all Forecasts provided hereunder to minimize variances between Forecasts. Each Forecast shall be duly signed by an authorized representative of Autolus (or Autolus’ designee on behalf of Autolus) and submitted in writing to Miltenyi, OptiNose 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 CPL each month with non-binding, rolling within [***] Business Days of receipt of the initial Forecasts from Autolus. (a) Rolling [***] Forecast; Firm Zone. Within [***] Business Days of the Effective Date, and thereafter by the [***] Business Day of each [***] during the Term, Autolus (or Autolus’ designee on behalf of Autolus) shall submit a [***] rolling Forecast of Autolus’ anticipated demand of Miltenyi Products for each of the next [***] consecutive Calendar [***]) month forecast of its Product requirements , commencing with the Calendar [***] in which such Forecast is submitted (each, a “Rolling [***] Forecast”). OptiNose The [***] Forecast shall be obligated to purchase the unit quantity of Products show demand on a [***] basis, and for the first [***] months shall state the desired dates of Delivery for the forecasted quantities. With respect to any Rolling Forecast that was requested in the Rolling Forecast for that [***] (Forecast for Miltenyi Products submitted during the Term, [***]) month period (a “Binding Period”). During ] of the quantities forecasted for the [***] period of each calendar month OptiNose will issue a new Rolling [***] Forecast which (each such [***] period shall be updated monthly referred to as the “Firm Zone”) shall be binding, and the corresponding portion of each subsequent [***] Forecast shall be consistent with such period. For clarity, all forecasted demands of Miltenyi Products during the Firm Zone shall constitute a binding commitment by OptiNose no later than 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 Business Day of each calendar month with the Binding Period updated with each Rolling Forecast to include the new Calendar [***] month during the Term, Autolus (or Autolus’ designee on behalf of the going forward Autolus) shall submit a non-binding [***] month Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with rolling Forecast of Autolus’ anticipated demand of Miltenyi Products for each of the [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not be required to place any Purchase Order for quantities that otherwise would be applicable for any Binding Period, and OptiNose may, in its sole discretion, cancel or modify any Purchase Order placed prior to the Final Approval Date; Calendar [***]. The Parties will work collaboratively together regarding planning of production of initial Product required to build initial launch quantities of Product in anticipation ] immediately following the last Calendar [***] 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’s standard lead time submitted pursuant to Section 2.5; provided that if new or additional 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 Agreementclause (a) above (each, a “[***] Forecast”). Each [***] Forecast shall show demand on a [***] basis.

Appears in 3 contracts

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

Forecasts. Commencing on A. Upon execution of the Effective DateAgreement, OptiNose BMPI shall provide CPL each month Chiron with a non-binding, rolling [***] ([***]) month 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 Product requirements (“Rolling Forecast”). OptiNose shall be obligated to purchase the unit quantity of Products for the first [***] months shorter of any Rolling Forecast (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 was requested BMPI will require in each month of the Rolling Forecast for that [***] ([***]) 15-month period (a “Binding Period”the "FORECASTED REQUIREMENTS"), and the requested delivery date(s). During the [***] C. The first six months of each calendar month OptiNose will issue a new Rolling the Forecast which shall be updated 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 OptiNose no later more than the [**), without Chiron's prior written consent. (i) At least *] ([***]) business day of each calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] month of the going forward [***] month Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not be required to place any Purchase Order for quantities that otherwise would be applicable for any Binding Period, and OptiNose may, in its sole discretion, cancel or modify any Purchase Order placed * days prior to the Final Approval Date; [date on which BMPI would like Product delivered, BMPI shall submit to Chiron a binding purchase order covering the Binding Requirements and, if desired, any, additional Product ** that BMPI would like to receive at that time (each, a "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) Chiron will fill each properly-submitted Purchase Order, to the extent of the Binding Requirement, by the delivery date requested therein or another date mutually agreed upon by the parties, in 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 Section 7.1, below, plus ***]. The Parties will work collaboratively together regarding planning of 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’s standard lead time pursuant to Section 2.5; provided that if new or additional 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 2 contracts

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

Forecasts. Commencing on the Effective Date, OptiNose shall provide CPL each month with non-binding, rolling [***] ([***]) month forecast of its Product requirements (“Rolling Forecast”). OptiNose shall be obligated to purchase the unit quantity of Products for the first [***] months of any Rolling Forecast that was requested in the Rolling Forecast for that [***] ([***]) month period (a “Binding Period”). During the [***] of each calendar month OptiNose will issue a new Rolling Forecast which shall be updated monthly by OptiNose no later than the [***] ([***]) business day of each calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] month of the going forward [***] month Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not be required to place any Purchase Order for quantities that otherwise would be applicable for any Binding Period, and OptiNose may, in its sole discretion, cancel or modify any Purchase Order placed prior to the Final Approval Date; [***]. The Parties will work collaboratively together regarding planning of 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 Buyer shall ensure thatuse its best efforts to update, subject on a quarterly basis, a continuous usage forecast to utilization assist Seller in maintaining an orderly production flow for the purpose of OptiNose Equipmentmeeting Buyer's delivery requirements. Buyer's failure to provide such information may be considered cause by Seller for excusable delivery delay. 3. CANCELLATION Buyer may cancel orders placed in accordance with the terms and conditions of this Agreement upon payment of cancellation charges which shall include all costs incurred or committed for, and a reasonable profit on such costs, unless (i) such costs are otherwise recoverable through the sale of the product on a timely basis or (ii) Buyer's cancellation is due to Motorola's failure to meet its forecasted delivery schedule resulting in cancellation of Product orders by Buyer's own customer. Payment of cancellation charges shall be due within thirty (30) days of the date of invoice. Seller agrees to divert completed material and work in process from canceled orders to other requirements wherever possible in order to minimize cancellation charges. 4. DELIVERY AND PAYMENT (a) All deliveries are FOB Motorola's plant. Each such delivery will be separately invoiced and payment from Buyer shall be due thirty (30) days from the date thereof without regard to other deliveries. DELIVERY DATES ARE BEST ESTIMATES ONLY. (b) Title to the Products sold shall pass to Buyer at the FOB point. Buyer hereby grants to MOTOROLA a security interest and lien upon all of Buyer's now existing or hereafter acquired inventory of the products, and all of Buyer's account, chattel paper, instruments, contract rights, general intangibles, accounts receivable and the 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 security interest and lien upon request. 5. FORCE MAJEURE MOTOROLA shall not be liable for any delay or failure to perform due to any cause beyond its reasonable control. Causes include but are not limited to strikes, 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 has shall be reduced on a pro rata basis. In the Capacity event MOTOROLA is unable to meet all wholly or partially perform for a period greater than forty-five (45) days because 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 CPL will inform OptiNose with sufficient lead time for such OptiNose Equipment to be acquired and qualified for use under this Agreementany cause beyond its reasonable control, either party may terminate any delayed order without any liability.

Appears in 2 contracts

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

Forecasts. Commencing on (a) Prior to the Effective Dateexecution of this Agreement, OptiNose EyePoint shared with Alimera its 2023 demand forecast for the Product for the U.S. market. At least [***] prior to the commencement of each Agreement Year during the Term after the first Agreement Year, EyePoint and Alimera shall provide CPL each month with discuss [***] a non-binding, rolling binding plan of Product supply quantities and timelines for the upcoming Agreement Year based on [***] (the “Agreement Year Plan”). (b) At least [***]) month [***] prior to the beginning of each Calendar Quarter occurring during the Term, Alimera shall deliver to EyePoint a proposed [***] rolling forecast of its the quantities of the Product requirements that ▇▇▇▇▇▇▇ expects to order [***] (the “Rolling Forecast”). OptiNose The Parties shall be obligated to purchase the unit quantity of Products for the first [***][***] months of any review each Rolling Forecast that was proposed by ▇▇▇▇▇▇▇ and discuss any limitations on the quantities of Product requested in the Rolling Forecast by ▇▇▇▇▇▇▇ for that [***] (of the Rolling Forecast based on capacity and other relevant factors. The Parties shall [***] agree on the Rolling Forecast for [***] within [***] after EyePoint’s receipt thereof. EyePoint will automatically be deemed to have accepted such portion of the Rolling Forecast if it has not sent written notice to Alimera of its rejection of such portion within [***] after EyePoint receives the Rolling Forecast. Such written notice must include [***] its reason for rejecting such portion of the Rolling Forecast and the amounts that it can accept for such period. If EyePoint provides such written notice to ▇▇▇▇▇▇▇, then the Parties shall [***] agree on [***] of the Rolling Forecast within [***] after ▇▇▇▇▇▇▇’s receipt thereof, and if the Parties are not able to agree on such portion of the Rolling Forecast during such period, then EyePoint’s counterproposal in its written notice will automatically be deemed accepted by ▇▇▇▇▇▇▇. The [***]) month period (a of each Rolling Forecast [***] shall be binding upon the Parties and referred to herein as the “Binding PeriodFirm Order”). During EyePoint may decline to approve and adjust any portion of the [***] of each calendar month OptiNose will issue a new Rolling Forecast which by providing written notice to Alimera within [***] of receipt thereof; provided, that (i) EyePoint shall be updated monthly by OptiNose no later than approve the [***]s of each Rolling Forecast that is within [***] percent ([***]%) business day of each calendar month with the Binding Period updated with each quantity requirements for the same period in the immediately preceding Rolling Forecast to include the new [***] month of the going forward [***] month extent previously approved by EyePoint, and (ii) not otherwise act unreasonably in declining to approve and adjusting any such Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with Once approved, the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not Firm Order may only 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; changed by [***]. The Parties If EyePoint fails to provide its written notice to adjust during such [***] period, then such portion of such Rolling Forecast will work collaboratively together regarding planning automatically be deemed accepted by EyePoint. Attached hereto as Exhibit B is the initial Rolling Forecast, the Firm Order of 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 which is based on [***] demand forecast for the applicable Rolling Forecast under this Agreement and subject to Product for the Product’s standard lead time pursuant to Section 2.5; provided that if new or additional 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 AgreementU.S. market.

Appears in 1 contract

Sources: Commercial Supply Agreement (EyePoint Pharmaceuticals, Inc.)

Forecasts. Commencing on the Effective Date, OptiNose shall Distributor agrees to provide CPL each month ▇▇▇▇▇▇▇▇ with non-binding, rolling [***] a three ([***]3) month forecast of its Product requirements (“Rolling Forecast”). OptiNose shall be obligated to purchase the unit quantity indicating Distributor's intended purchases of Products for the first [***] months of any Rolling Forecast that was requested in the Rolling Forecast for that [***] ([***]) month period (a “Binding Period”). During the [***] of during each calendar month OptiNose will issue a new Rolling Forecast which shall be updated monthly by OptiNose no later than the [***] ([***]) business day quarter of each calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] month of the going forward [***] month Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not be required to place any Purchase Order for quantities that otherwise would be applicable for any Binding Period, and OptiNose may, in its sole discretion, cancel or modify any Purchase Order placed prior to the Final Approval Date; [***]. The Parties will work collaboratively together regarding planning of 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 . (a) ▇▇▇▇▇▇▇▇ acknowledges that Distributor will order Products to meet all specific contractual commitments to Distributor's dealers and their customers for delivery by specified dates, and that the consequences of OptiNose’s requirements late delivery may be significant. Accordingly, if ABioNova anticipates any delays or interruptions in the delivery of the Products which are estimated to extend for Product more than ten (I 0) days past the delivery date stated for the Products in a timely manner based purchase order which has been accepted by ABioNova (an "Agreed Delivery Date"), ABioNova shall notify Distributor of the estimated date on which delivery will be made, and shall cooperate with Distributor in rescheduling deliveries to minimize the effect of such delays and interruptions on Distributor. If Distributor notifies ▇▇▇▇▇▇▇▇ in writing in the order and acceptance process for a Product purchase that late delivery penalties or other amounts will be payable to a customer if delivery of the Products is delayed past an Agreed Delivery Date, and ABioNova causes such a delay to occur, ABioNova shall reimburse Distributor for the full amount of such penalties and other amounts. ABioNova's payment of such penalties and other amounts shall be Distributor's sole and exclusive remedy in the event that delivery of the Products is delayed beyond the Agreed Delivery Date, and ABioNova shall have no further responsibility or liability to Distributor in connection therewith. (b) Notwithstanding the provisions of Subsection 5.7(a) hereof: (i) In the event that ▇▇▇▇▇▇▇▇ and Distributor agree to a change in a purchase order after such purchase order has been accepted by ABioNova, the Agreed Delivery Date shall be of no force and effect, and a new Agreed Delivery Date shall be agreed upon by Distributor and ▇▇▇▇▇▇▇▇. (ii) In the event that Distributor fails to pay to ABioNova an amount equal to forty percent (40%) of the price of the Products within five (5) business days of ABioNova's acceptance of the purchase order to which such Products relate, as described in Subsection 7.3(a)(i) hereof, the Agreed Delivery Date shall be of no force or effect, and a new Agreed Delivery Date shall be agreed upon by ABioNova and Distributor at such time as Distributor pays an amount equal to forty percent (40%) of the price of such Products to ABioNova. (iii) In the case of an event of Force Majeure which prevents ABioNova from delivering Products to Distributor on an Agreed Delivery Date, ABioNova shall not be liable to Distributor for its failure to deliver Products on the applicable Rolling Forecast under this Agreement Agreed Delivery Date, and subject to the Product’s standard lead time pursuant to provisions of Section 2.5; provided that if new 5.7(a) shall be of no force or additional 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 Agreementeffect.

Appears in 1 contract

Sources: Distributorship Agreement

Forecasts. Commencing on (a) Prior to the Effective Dateexecution of this Agreement, OptiNose EyePoint shared with ▇▇▇▇▇▇▇ its 2023 demand forecast for the Product for the U.S. market. At least [***] prior to the commencement of each Agreement Year during the Term after the first Agreement Year, EyePoint and Alimera shall provide CPL each month with discuss [***] a non-binding, rolling binding plan of Product supply quantities and timelines for the upcoming Agreement Year based on [***] (the “Agreement Year Plan”). (b) At least [***]) month [***] prior to the beginning of each Calendar Quarter occurring during the Term, Alimera shall deliver to EyePoint a proposed [***] rolling forecast of its the quantities of the Product requirements that Alimera expects to order [***] (the “Rolling Forecast”). OptiNose The Parties shall be obligated to purchase the unit quantity of Products for the first [***][***] months of any review each Rolling Forecast that was proposed by ▇▇▇▇▇▇▇ and discuss any limitations on the quantities of Product requested in the Rolling Forecast by ▇▇▇▇▇▇▇ for that [***] (of the Rolling Forecast based on capacity and other relevant factors. The Parties shall [***] agree on the Rolling Forecast for [***] within [***] after EyePoint’s receipt thereof. EyePoint will automatically be deemed to have accepted such portion of the Rolling Forecast if it has not sent written notice to Alimera of its rejection of such portion within [***] after EyePoint receives the Rolling Forecast. Such written notice must include [***] its reason for rejecting such portion of the Rolling Forecast and the amounts that it can accept for such period. If EyePoint provides such written notice to ▇▇▇▇▇▇▇, then the Parties shall [***] agree on [***] of the Rolling Forecast within [***] after ▇▇▇▇▇▇▇’s receipt thereof, and if the Parties are not able to agree on such portion of the Rolling Forecast during such period, then 5 EyePoint’s counterproposal in its written notice will automatically be deemed accepted by ▇▇▇▇▇▇▇. The [***]) month period (a of each Rolling Forecast [***] shall be binding upon the Parties and referred to herein as the “Binding PeriodFirm Order”). During EyePoint may decline to approve and adjust any portion of the [***] of each calendar month OptiNose will issue a new Rolling Forecast which by providing written notice to Alimera within [***] of receipt thereof; provided, that (i) EyePoint shall be updated monthly by OptiNose no later than approve the [***]s of each Rolling Forecast that is within [***] percent ([***]%) business day of each calendar month with the Binding Period updated with each quantity requirements for the same period in the immediately preceding Rolling Forecast to include the new [***] month of the going forward [***] month extent previously approved by EyePoint, and (ii) not otherwise act unreasonably in declining to approve and adjusting any such Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with Once approved, the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not Firm Order may only 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; changed by [***]. The Parties If EyePoint fails to provide its written notice to adjust during such [***] period, then such portion of such Rolling Forecast will work collaboratively together regarding planning automatically be deemed accepted by EyePoint. Attached hereto as Exhibit B is the initial Rolling Forecast, the Firm Order of 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 which is based on [***] demand forecast for the applicable Rolling Forecast under this Agreement and subject to Product for the Product’s standard lead time pursuant to Section 2.5; provided that if new or additional 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 AgreementU.S. market.

Appears in 1 contract

Sources: Commercial Supply Agreement (Alimera Sciences Inc)

Forecasts. Commencing (a) The ▇▇▇▇ and Corium advisory committee (Committee) will meet at least [*] prior to the Launch Date of the Product for the purpose of planning a successful Product launch. Corium will prepare a Production Launch Plan for the Product based on ▇▇▇▇’▇ estimated launch quantity and estimated launch date within [*]after receipt of non-binding estimated launch quantities and launch date from ▇▇▇▇. ▇▇▇▇ will place firm purchase orders for the Effective DateProduct far enough in advance to meet ▇▇▇▇’▇ launch requirements based on Corium’s Production Launch Plan. (b) After the Launch Date of the Product within the Territory, OptiNose [*] prior to the beginning of each calendar year, ▇▇▇▇ shall provide CPL 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 month with [*]. Except as otherwise provided herein, these requirements forecasts shall be non-binding, rolling binding and shall be used by Corium for planning purposes only. (c) [*] prior to [*], ▇▇▇▇ shall submit to Corium a Firm Order for the Product with a shipment date no sooner than [*] (from the date of the Firm Order. Corium shall accept or reject a Firm Order within [***]) month forecast of its Product requirements (“Rolling Forecast”)receipt. OptiNose Corium may reject a Firm Order if at the time of its receipt ▇▇▇▇ is in default of a payment or other obligation or if Corium is unable to fill the Firm Order within the time specified. If Corium fails to accept or reject a Firm Order within such [*] period, such Firm Order shall be obligated deemed to be accepted at the end of such period. Except as provided herein, the Firm Order shall constitute a binding agreement by ▇▇▇▇ to purchase the unit quantity Product. No change may be made in the binding purchase order for Product or the shipment dates requested therefor without the prior consent of Products Corium (such consent not to be unreasonably withheld). (d) Should ▇▇▇▇’▇ Firm Order for a calendar quarter be less than ▇▇▇▇’▇ most recent forecast for such calendar quarter pursuant to Section 8.4(b), ▇▇▇▇ will pay Corium for the first [***] months costs of any Rolling Forecast that was requested unused quantities of such materials ordered for such calendar quarter in the Rolling Forecast for that reliance on such forecast within [***] ([***]) month period (a “Binding Period”). During the [***] of each such Firm Order; provided however that Corium shall use commercially reasonable effort to store such materials under proper storage conditions and use such materials to manufacture the Product for future calendar month OptiNose will issue quarters, and shall reimburse or *Confidential Treatment Requested. credit ▇▇▇▇ for costs of all materials so used for a new Rolling Forecast which shall be updated monthly by OptiNose no later than the future calendar quarter within [***] ([***]) business day after the end of each such future calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] month of the going forward [***] month Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not be required to place any Purchase Order for quantities that otherwise would be applicable for any Binding Period, and OptiNose may, in its sole discretion, cancel or modify any Purchase Order placed prior to the Final Approval Date; [***]. The Parties will work collaboratively together regarding planning of 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’s standard lead time pursuant to Section 2.5; provided that if new or additional 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 Agreementquarter.

Appears in 1 contract

Sources: Development, Manufacturing and Commercialization Agreement

Forecasts. Commencing on the Effective Date, OptiNose shall provide CPL each month with non-binding, rolling [***] ([***]) month forecast of its Product requirements (“Rolling Forecast”). OptiNose shall be obligated to purchase the unit quantity of Products for the first [***] months of any Rolling Forecast that was requested in the Rolling Forecast for that [***] ([***]) month period (a “Binding Period”). During the [***] of each calendar month OptiNose will issue a new Rolling Forecast which shall be updated monthly by OptiNose no later than the [***] ([***]) business day of each calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] month of the going forward [***] month Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not be required to place any Purchase Order for quantities that otherwise would be applicable for any Binding Period, and OptiNose may, in its sole discretion, cancel or modify any Purchase Order placed prior to the Final Approval Date; [***]. The Parties will work collaboratively together regarding planning of 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 PCYC shall ensure that, subject provide to utilization DOTTIKON [ *** ] a written rolling forecast of OptiNose Equipment, the quantities of such Product it has the Capacity intends in good faith to meet all of OptiNose’s requirements for Product in a timely manner based on the applicable Rolling Forecast purchase under this Agreement during [ *** ] For example, the forecast provided at [ *** ] will cover the quantities of Products to be delivered during [ *** ] Each such forecast shall have the following effect, except as otherwise set forth in the applicable Product Appendix: [ *** ] [ *** ]; and [ *** ]; and [ *** ] Purchase Orders. 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 Purchase Order, or to such other location and/or within such other time period as may be specified in the applicable Product Appendix. DOTTIKON shall ship all Products as set forth in Section 4.5 by the date and in the quantities specified in the applicable Purchase Order. 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 Product’s standard lead time pursuant applicable Product Appendix. DOTTIKON shall be obligated to Section 2.5; provided accept any Purchase Order that if new or additional OptiNose Equipment is required CPL will inform OptiNose with sufficient lead time does not require DOTTIKON to Manufacture a Product in quantities in excess of DOTTIKON's Capacity for such OptiNose Equipment Product, and shall use its best efforts to accept any Purchase Order in excess thereof. Any Purchase Order (or portion thereof) for which PCYC has not received a written rejection from DOTTIKON within [ *** ] of DOTTIKON's receipt of such Purchase Order shall automatically be acquired and qualified 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 use under 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

Sources: Supply Agreement (Pharmacyclics Inc)

Forecasts. Commencing (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 Effective Datemanufacturing 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, OptiNose ,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 [***] basis, Customer shall provide CPL each month Corden with non-binding, a rolling [***]-month forecast (“Rolling Forecast”) indicating Customer’ expected delivery of Product for the next [***] (i.e., [***]) month forecast of its Product requirements ), in full batch sizes. The first [***] months (“Rolling Forecast”). OptiNose shall be obligated to purchase the unit quantity of Products for i.e., the first [***] months ) of any Rolling Forecast that was requested in the Rolling Forecast (i.e., [***]) shall be considered binding for that both Parties under this Section 5 (“Binding Forecast”), and the second [***] period (i.e., [***]) shall be considered non-binding for both Parties (“Non-Binding Forecast”). The initial Rolling Forecast is attached hereto as Schedule 1, and each subsequent update will be due on or before the [***] Business Day of each new [***] during the Term (covering such new [***] and the subsequent [***] ). (c) Corden shall review each update to the Rolling Forecast and assess if it is able to manufacture or otherwise supply Customer’ requirements for Product in excess of the amount set forth in the previous Binding Forecast, if any, and assuming that the remainder of the Rolling Forecast will become binding in time as contemplated by this Agreement. In the event that, upon receipt of an updated Rolling Forecast, Corden anticipates that it shall not be able to manufacture or otherwise supply Customer’ requirements for Product in excess of the amount set forth in the previous Binding Forecast, Corden shall inform Customer in writing within [***] Business Days after ▇▇▇▇▇▇’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 able to manufacture or otherwise supply for Customer. For the avoidance of doubt, ▇▇▇▇▇▇ will not be obliged to manufacture any portion of the initial Binding Forecast that requires a capital investment in the Production Facility, 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 ([***]%) month period over the previous Non-Binding Forecast. The Parties agree to discuss as soon as practicable any such overage request, provided ▇▇▇▇▇▇ will use commercially reasonable efforts to fulfill such overage and any other additional Product requirement of Customer not contemplated by the updated Binding Forecast. (a “Binding Period”). During the e) Within [***] Business Days after receipt of each calendar month OptiNose will issue Rolling Forecast, Corden shall submit to Customer a new corresponding good faith, non-binding, estimated rolling forecast of Corden’s expected requirements of/for Customer Material based on such Rolling Forecast which (taking into account any released quantities of Customer Material already on hand at the Production Facility). Each such forecast provided by Corden shall be updated monthly by OptiNose no later than 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 [***] ([***]) business day days or as specified in the Product Addendum for analytical testing and release of each calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] month of the going forward [***] month Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not be required to place any Purchase Order for quantities that otherwise would be applicable for any Binding Period, and OptiNose may, in its sole discretion, cancel or modify any Purchase Order placed prior to the Final Approval Date; [***]. The Parties will work collaboratively together regarding planning of 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’s standard lead time pursuant to Section 2.5; provided that if new or additional 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 AgreementCustomer Materials by Corden.

Appears in 1 contract

Sources: Commercial Supply Agreement (Acadia Pharmaceuticals Inc)

Forecasts. Commencing on the Effective Date, OptiNose ORPHAN shall provide CPL Supplier with forecasts of ORPHAN’S anticipated [ * ] requirements of the Drug for distribution and sale in the United States commencing with the [ * ] period that begins at the time of an FDA approval. Such forecast will be provided [ * ] in advance of anticipated FDA approval of the NDA and ORPHAN shall update such [ * ] forecast on a [ * ] basis thereafter. Once FDA approval of the Drug is received, ORPHAN will provide Supplier, prior to the beginning of each month [ * ], with non-bindingforecasts of its anticipated requirements of the Drug for the following [ * ]. Supplier will provide [ * ] anticipated schedule for manufacture and will consult with ORPHAN on schedule changes. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, rolling [***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 Drug for ORPHAN during [ * ]. (b) Supplier shall [ * ] manufacture during any [ * ] up to [ * ] of the quantity of the Drug ORPHAN forecasted it would purchase from Supplier during such [ * ] in its most recent forecast covering [ * ]. Supplier will promptly communicate with ORPHAN as to its ability to produce quantities requested. (c) When and as ORPHAN proposes to commence its distribution and sale of the 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 [ * ] are that during such [ * ] ([***]i) month forecast of its Product requirements (“Rolling Forecast”). OptiNose ORPHAN shall be obligated required to purchase [ * ] the unit quantity of Products for the first [***] months of any Rolling Forecast that was requested amount set forth in the Rolling Forecast for that [***[ * ] and ([***]ii) month period (a “Binding Period”). During the [***] of each calendar month OptiNose will issue a new Rolling Forecast which Supplier shall be updated monthly by OptiNose no later required to manufacture [ * ] such amount. If ORPHAN does not deliver a [ * ], Supplier may accept [ * ] use its [ * ] to produce the Drug in accordance with ORPHAN’S purchase orders in a timely manner. It is agreed that this procedure will be used on an exception basis. (e) If Supplier manufactures the Drug with a lead time of more than the [***] ([***[ * ]) business day of each calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] month of the going forward [***] month Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose ORPHAN shall not be required to place pay any Purchase Order additional storage, or pay for quantities that otherwise would be applicable for the Drug sooner than as set forth in Section 7.5 nor shall any Binding Period, and OptiNose may, in its sole discretion, cancel or modify any Purchase Order placed prior advance manufacture lead to the Final Approval Date; [***]. The Parties will work collaboratively together regarding planning of production of initial Product required to build initial launch quantities of Product in anticipation a violation of the Final Approval Date. During the term warranty 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 expiration date set forth 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 CPL will inform OptiNose with sufficient lead time for such OptiNose Equipment to be acquired and qualified for use under this Agreement8.1.

Appears in 1 contract

Sources: Development and Supply Agreement (Jazz Pharmaceuticals Inc)

Forecasts. Commencing on the Effective DateFinal Approval Date or such earlier date as may be agreed to between the Parties, OptiNose shall provide CPL Hikma each month with non-binding, rolling [***] ([***]) month forecast of its Product requirements (“Rolling Forecast”). OptiNose shall be obligated to purchase the unit quantity of Products for the first [***] months of any Rolling Forecast that was requested in the Rolling Forecast for that [***] ([***]) month period (a “Binding Period”). During the [***] first business week of each calendar month month, OptiNose will issue a new Rolling Forecast which shall be updated monthly by OptiNose no later than the [***] fifth ([***]5th) business day of each calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] month of the going forward [***] month Rolling Forecast. CPL Hikma shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriateappropriate or as OptiNose may reasonably request. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not be required to place any Purchase Order for quantities that otherwise would be applicable for any Binding Period, and OptiNose may, in its sole discretion, cancel or modify any Purchase Order placed prior to the Final Approval Date; [***]provided, however, that OptiNose will reimburse Hikma for any out-of-pocket costs reasonably incurred in order for Hikma to be prepared to supply Product for such Purchase Orders (including, without limitation, the cost of Raw Materials purchased by Hikma based on such Rolling Forecasts that cannot otherwise be reasonably used by Hikma or its customers) and any other costs agreed to by the Parties. The Parties will work collaboratively together regarding planning of production of initial Product required to build initial launch quantities of Product in anticipation of the Final Approval Date. During the term Term of this Agreement, CPL 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 CPL required, Hikma 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

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

Forecasts. Commencing on the Effective Date, OptiNose ORPHAN shall provide CPL Catalytica with forecasts of ORPHAN’S anticipated [ * ] requirements of the Product for distribution and sale in the United States commencing with the [ * ] period 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 ORPHAN shall update such [ * ] forecast on [ * ] basis thereafter. Once FDA approval of the Product is received, ORPHAN will provide Catalytica, prior to the beginning of each month [ * ], with non-binding, rolling [***] ([***]) month forecast forecasts of its anticipated requirements of the Product requirements (“Rolling Forecast”). OptiNose shall be obligated to purchase for the unit quantity of Products following [ * ] and the forecast for the first [***[ * ] months of 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 Rolling Forecast that was requested in the Rolling Forecast for that [***[ * ] ([***]) month period (a “Binding Period”). During the [***up to [ * ] of each calendar month OptiNose will issue a new Rolling Forecast which shall be updated monthly by OptiNose no later than the [***] ([***]) business day of each calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] month quantity of the going forward [***Product ORPHAN forecasted it would purchase from Catalytica during such [ * ] month Rolling Forecastin its most recent forecast covering [ * ]. CPL Catalytica will promptly communicate with ORPHAN as to its ability to produce quantities requested. (b) When and as ORPHAN proposes to commence its distribution and sale of the Product outside the United States, ORPHAN shall participate in periodic sales and operations planning meetings 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 [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. OptiNose and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision a lead time of this Agreementmore than [ * ], for Rolling Forecasts issued prior to Final Approval Date, OptiNose ORPHAN shall not be required to place pay any Purchase Order additional storage, or pay for quantities that otherwise would be applicable for the Product sooner than as set forth in Section 7.7 nor shall any Binding Period, and OptiNose may, in its sole discretion, cancel or modify any Purchase Order placed prior advance manufacture lead to the Final Approval Date; [***]. The Parties will work collaboratively together regarding planning of production of initial Product required to build initial launch quantities of Product in anticipation a violation of the Final Approval Date. During the term warranty 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 expiration date set forth 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 CPL will inform OptiNose with sufficient lead time for such OptiNose Equipment to be acquired and qualified for use under this Agreement8.1.

Appears in 1 contract

Sources: Supply Agreement (Jazz Pharmaceuticals Inc)

Forecasts. Commencing 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 Effective Datebasis 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, OptiNose 2000 is [*] Beginning [*] after the first delivery order, the BUYER shall provide CPL each month with non-binding, then deliver to [*] * 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 COMPANY a revised forecast at least once per [*] on a rolling [**] basis. 4.4 Forecasts provided under the paragraph (4.3) 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, however, the BUYER agrees to place orders consistent with such forecasts. The volume ordered by the BUYER in any given month may be increased or decreased from the volume included in the forecast and there shall be no fee associated with such variance. If the BUYER submits any forecast or places any order in which the quantity of PRODUCTS forecasted or ordered for any month deviates by more than [*] (from the forecasted quantity of PRODUCTS for such [***]) month forecast of its Product requirements (“Rolling Forecast”). OptiNose shall be obligated to purchase the unit quantity of Products for the first [***] months of any Rolling Forecast that was requested contained in the Rolling Forecast for that [***] ([***]) month period (a “Binding Period”). During the [***] of each calendar month OptiNose will issue a new Rolling Forecast which shall be updated monthly by OptiNose no later than the [***] ([***]) business day of each calendar month with the Binding Period updated with each Rolling Forecast to include the new [***] month of the going forward [***] month Rolling Forecast. CPL shall participate in periodic sales and operations planning meetings with [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect most recent prior forecast submitted to the omitted portions. OptiNose COMPANY, then the parties shall negotiate in good faith to determine a mutually agreeable delivery schedule, taking into account BUYER's delivery requirements and other suppliers as both Parties reasonably deem appropriate. Notwithstanding any other provision of this Agreement, for Rolling Forecasts issued prior to Final Approval Date, OptiNose shall not be the 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; [***]. The Parties will work collaboratively together regarding planning of 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’s standard lead time pursuant to Section 2.5; provided that if new or additional OptiNose Equipment is required CPL will inform OptiNose with sufficient lead time for any modifications to the COMPANY's procurement, manufacturing and testing processes. 4.5 In addition to the formal procedures set forth above, the parties agree that they will promptly inform each other of any material change in their expectations or capabilities relating to the manufacturing, ordering or delivery of PRODUCTS hereunder, such OptiNose Equipment to be acquired as altered requirements and qualified for use under this Agreementdifficulties in productions.

Appears in 1 contract

Sources: Sales Agreement (Utstarcom Inc)