Common use of Firm Orders Clause in Contracts

Firm Orders. On a rolling basis during the term of the Product Agreement, Client will issue an updated [***] forecast on or before the [***]. This forecast will start on [***]. Unless otherwise agreed in the Product Agreement, the first [***] of this updated forecast will be considered binding firm orders. Concurrent with the [***] forecast, Client will issue a new firm written order in the form of a purchase order or otherwise (“Firm Order”) by Client to purchase and, when accepted by Patheon, for Patheon to manufacture and deliver the agreed quantity of the Products. The Delivery Date will not be less than [***] following the date that the Firm Order is submitted. Firm Orders submitted to Patheon will specify Client's purchase order number, quantities by Product type, monthly delivery schedule, and any other elements necessary to ensure the timely manufacture and shipment of the Products. The quantities of Products ordered in those written orders will be firm and binding on Client and may not be reduced by Client. Further, for [***] of the [***] forecast, Client commits that its Firm Orders for each of those months will be no less than [***], respectively, of the forecasted amounts for [***]. If Client orders less than the agreed volume, the parties will meet to discuss how to smooth production to meet demand. If it is not possible to smooth production to meet forecasted demand, Client will compensate Patheon for not meeting the Firm Order commitment by paying the [***] for the shortfall between what Client actually ordered and its Firm Order commitment as set forth above or as otherwise provided for in the applicable Product Agreement. The forgoing shall be Patheon’s sole and exclusive remedy for Client’s failure to meet the Firm Order commitment. No amounts shall be payable to Patheon if Client is unable to make the Firm Order commitment because of Force Majeure or because the Product is taken off the market due in response to an action by an Authority or otherwise as required by Applicable Law. Patheon commits to make [***] of the forecasted amounts available to Client, and will reserve [***] of its capacity to meet that commitment. Patheon shall notify Client as soon as possible of impending capacity constraints in relation to Client’s forecasts and/or changes in Client’s demands.

Appears in 2 contracts

Samples: Master Manufacturing Services Agreement (Akebia Therapeutics, Inc.), Master Manufacturing Services Agreement (Keryx Biopharmaceuticals Inc)

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Firm Orders. On a rolling basis during the term 3.3.1. The Company agrees to supply to Sandoz [*] quantities of the Product Agreement, Client will issue an updated [***] forecast on ordered by Sandoz pursuant to one or before the [***]. This forecast will start on [***]. Unless otherwise agreed more purchase orders issued in the Product Agreement, the first [***] of this updated forecast will be considered binding firm orders. Concurrent accordance with the [***] forecastterms and conditions hereof (each, Client will issue as accepted by the Company in accordance with Section 3.3.2, a new firm written order in the form of a purchase order or otherwise (“Firm Order”) ). Sandoz shall issue Firm Orders to the Company for the purchase of the quantities described therein, and upon acceptance by Client the Company in accordance with Section 3.3.2, each Firm Order shall be considered a binding, non-cancellable commitment upon the Company to produce and deliver such quantities of Product on the delivery dates described therein and upon Sandoz to purchase andand pay for such quantities of Product. 3.3.2. The Company shall confirm to Sandoz all Firm Orders, when accepted by Patheonincluding quantities, pricing, commercial terms, and delivery dates, in writing within [*] after receipt (or within a reasonable period of time after receipt for Patheon to manufacture and deliver the agreed quantity orders in excess of the ProductsFirm Commitment). Any such confirmation shall either confirm the delivery date set out in the Firm Order or provide a reasonable alternative delivery date. Any Firm Orders not expressly accepted or rejected by the Company shall be deemed to have been accepted. The Delivery Date Company may reject any Firm Order in excess of the Firm Commitment or otherwise not given in accordance with this Agreement; provided, however, that the Company shall [*] to supply Sandoz with quantities of Product which are in excess of the quantities specified in the Firm Commitment, subject to [*]. For clarity, the Company will not be less than considered in breach or default if it does not supply quantities of Product which are in excess of the quantities specified in the Firm Commitment after [**]. [*] following designates portions of this document have been omitted pursuant to a request for confidential treatment filed separately with the date that the Commission. Confidential treatment has been required with respect to this omitted information. 3.3.3. Sandoz shall provide each Firm Order is submittedto the Company concurrently with the submission of each Rolling Forecast, and (a) with respect to Product quantities for Launch at least [*] prior to the delivery date specified therein and (b) with respect to all subsequent quantities of Product, at least [*] prior to the delivery date specified therein. Each Firm Orders submitted to Patheon will specify Client's Order shall specify: (i) purchase order number, ; (ii) the name and quantities of the Product to be purchased by Product type, monthly and supplied to Sandoz; (iii) the delivery schedule, dates and shipping instructions with respect thereto; (iv) Supply Price of the Product; (v) payment terms; and (vi) any other elements necessary to ensure the timely manufacture production and shipment delivery of the ProductsProduct. The quantities of Products ordered Each Firm Order shall constitute a contract, and the Parties shall comply in those written orders will be firm and binding on Client and may not be reduced by Client. Furtherall respects with the obligations set forth therein including, for [***] without limitation, the obligation of the [***] forecastCompany to deliver the Product on the delivery date set forth in the Firm Order; provided, Client commits however, that its Firm Orders except for each the information specified in clauses (ii) and (iii) of those months will be no less than [***]this Section, respectivelythe supply, purchase and sale of the forecasted amounts for [***]. If Client orders less than the agreed volume, the parties will meet to discuss how to smooth production to meet demand. If it is not possible to smooth production to meet forecasted demand, Client will compensate Patheon for not meeting the Firm Order commitment by paying the [***] for the shortfall between what Client actually ordered and its Firm Order commitment as set forth above or as otherwise provided for in the applicable Product Agreement. The forgoing Products shall be Patheon’s sole governed solely by this Agreement and exclusive remedy for Client’s failure to meet the any additional or contrary terms or provisions contained in any Firm Order commitment. No amounts Order, purchase order or similar form or invoice or acknowledgment shall be payable to Patheon if Client is unable to make the Firm Order commitment because of Force Majeure void and have no force or because the Product is taken off the market due in response to an action by an Authority or otherwise as required by Applicable Law. Patheon commits to make [***] of the forecasted amounts available to Client, and will reserve [***] of its capacity to meet that commitment. Patheon shall notify Client as soon as possible of impending capacity constraints in relation to Client’s forecasts and/or changes in Client’s demandseffect.

Appears in 2 contracts

Samples: Distribution and Commercialization Agreement, Distribution and Commercialization Agreement (Adamis Pharmaceuticals Corp)

Firm Orders. On a rolling basis during the term of the Product Agreement, Client will issue an updated (a) At least [***] forecast on or before days prior to the beginning of each MONTH during the TERM, MERCK shall place an order (a "FIRM ORDER") for its requirements of PRODUCT for such MONTH. Each FIRM ORDER shall specify the quantity of PRODUCT ordered, the required DELIVERY date and the shipping address. For the period prior to the [***]. This forecast will start on ] anniversary of the FIRST COMMERCIAL SALE, each FIRM ORDER shall not be less than [***]. Unless otherwise agreed in the Product Agreement, the first nor more than [***] of this updated forecast will be considered binding firm orders. Concurrent with the [***] forecastquantity for such MONTH, Client will issue a new firm written order as set forth in the form of a purchase order or otherwise (“Firm Order”) by Client to purchase andmost recent rolling forecast for such MONTH, when accepted by Patheonand for the periods thereafter, for Patheon to manufacture and deliver the agreed quantity of the Products. The Delivery Date will each FIRM ORDER shall not be less than [***] following the date that the Firm Order is submitted. Firm Orders submitted to Patheon will specify Client's purchase order number, quantities by Product type, monthly delivery schedule, and any other elements necessary to ensure the timely manufacture and shipment of the Products. The quantities of Products ordered in those written orders will be firm and binding on Client and may not be reduced by Client. Further, for nor more than [***] of the quantity for such MONTH, as set forth in the most recent rolling forecast for such MONTH. If MERCK places a FIRM ORDER in excess of the maximum amount allowed for such MONTH pursuant to the foregoing sentence, NASTECH shall [***] forecast]. (b) Should MERCK request NASTECH to supply PRODUCT in excess of MERCK's most recent estimate of its requirements, Client commits that its Firm Orders for each of those months will be no less than NASTECH shall [***]. (c) MERCK may cancel or defer any FIRM ORDER [***], respectively, of provided that such cancellation notice is received by NASTECH at least [***] prior to the forecasted amounts scheduled DELIVERY date for PRODUCT. If MERCK cancels or defers a FIRM ORDER with less than the aforementioned notice NASTECH shall [***]. (d) NASTECH shall satisfy each FIRM ORDER on or before [***]. If Client orders less than the agreed volume, the parties will meet to discuss how to smooth production to meet demand. If it is not possible to smooth production to meet forecasted demand, Client will compensate Patheon for not meeting the Firm Order commitment by paying the [***] for the shortfall between what Client actually ordered and its Firm Order commitment as set forth above or as otherwise provided for in the applicable Product Agreement. The forgoing site(s) of MANUFACTURE shall be Patheon’s sole and exclusive remedy for Client’s failure to meet the Firm Order commitment. No amounts indicated on documents accompanying each shipment of PRODUCT. (e) A FIRM ORDER shall be payable made on such form of purchase order or document as MERCK may specify from time to Patheon if Client time in writing; provided that the terms and conditions of this AGREEMENT shall be controlling over any terms and conditions included in any FIRM ORDER. Any term or condition of such FIRM ORDER that is unable different from or contrary to make the Firm Order commitment because terms and conditions of Force Majeure or because the Product is taken off the market due in response to an action by an Authority or otherwise as required by Applicable Law. Patheon commits to make [***] of the forecasted amounts available to Client, and will reserve [***] of its capacity to meet that commitment. Patheon this AGREEMENT shall notify Client as soon as possible of impending capacity constraints in relation to Client’s forecasts and/or changes in Client’s demandsbe void.

Appears in 2 contracts

Samples: Supply Agreement, Supply Agreement (Nastech Pharmaceutical Co Inc)

Firm Orders. On a rolling basis during the term of the Product Agreement, Client will issue an updated [***] forecast on or before the [***]. This forecast will start on [***]. Unless otherwise agreed in the Product Agreement, the first [***] of this updated forecast will be considered binding firm orders. (i) Concurrent with the [***] forecastdelivery of the then-current Rolling Forecast, Client VF will issue a new firm written order in the form of a purchase order (specifying the Delivery Date or otherwise Delivery Dates that are at least [***] days after the date of the respective purchase order) (“Firm Order”) by Client for deliveries of the Bulk Drug Products to purchase andVF, when ensuring that CCX always has at least [***] days lead-time to deliver Bulk Drug Product to VF. When accepted by PatheonCCX as specified below, such Firm Order for Patheon CCX to manufacture Manufacture and deliver the agreed quantity of the Bulk Drug Products. The Delivery Date will not be less than In case of first launch, at least [***] following calendar days prior to the date that requested initial Shipping Date of Bulk Product or as soon as practicable after the Firm Order is submittedEffective Date of this Agreement, VF shall place an initial purchase order. CCXI will confirm receipt of such request and will use commercially reasonable efforts to accept and fulfill such purchase order. (ii) Firm Orders submitted to Patheon CCX will specify Client's VF’s purchase order number, quantities by Bulk Drug Product type, monthly delivery scheduleDelivery Date, and any other elements necessary to ensure the timely manufacture and shipment of the Productsdelivery location. The quantities of Bulk Drug Products ordered and Delivery Dates in those written orders Firm Orders will be firm and binding on Client VF and CCX (unless rejected under Section 5.1(d)) and may not be reduced by ClientVF or CCX except as expressly permitted in this Agreement. Further, for [***] of the [***] forecast, Client commits that its Expedited Firm Orders for each of those months will be no less than [***]subject to additional fees as agreed in writing by the Parties. (iii) If and when VF applies for a tender of Product to a Governmental Authority or if VF prepares for a launch of Product in a country, respectivelyor if VF requires Product prior to a launch date due to e.g., regulatory requirements as part of a submission, VF shall notify CCXI in writing and provide to CCXI information relating to the forecasted amounts anticipated volumes to be supplied under such tender or launch and the timing for [***]deliveries thereunder. If Client orders less than the agreed volumeIn such events, the parties Parties will meet discuss in good faith reasonable mechanisms for CCXI to discuss how provide supply of Product for such tender or launch The Parties agree that lead times for such orders related to smooth production to meet demand. If it is not possible to smooth production to meet forecasted demand, Client will compensate Patheon for not meeting the Firm Order commitment by paying the [***] for the shortfall between what Client actually ordered and its Firm Order commitment as set forth above or as otherwise provided for in the applicable Product Agreement. The forgoing shall be Patheon’s sole and exclusive remedy for Client’s failure to meet the Firm Order commitment. No amounts shall be payable to Patheon if Client is unable to make the Firm Order commitment because of Force Majeure or because the Product is taken off the market due in response to an action by an Authority or otherwise as required by Applicable Law. Patheon commits to make [***] of the forecasted amounts available to Client, and will reserve [***] of its capacity to meet that commitment. Patheon shall notify Client as soon as possible of impending capacity constraints in relation to Client’s forecasts a tender and/or changes in Client’s demandsa launch may have shorter lead times than regular orders.

Appears in 1 contract

Samples: Manufacturing and Supply Agreement (ChemoCentryx, Inc.)

Firm Orders. On a rolling basis during Notwithstanding the term forecasts set forth on Appendix B, as of the Product AgreementEffective Date, Client will issue an updated [***] forecast on or before the [***]. This forecast will start on [***]. Unless otherwise agreed in the Product Agreement, the first [***] of this updated forecast will be considered binding firm orders. Concurrent with the [***] forecast, Client will issue a new firm written order in the form of MEDINOL shall submit to ARIAD a purchase order or otherwise for such quantities of API as MEDINOL commits to purchase from ARIAD during the Initial Calendar Quarter, with a statement of the dates on which delivery is requested and shipping instructions (a “Firm Order”). Thereafter, at least forty-five (45) by Client days before the beginning of each succeeding Calendar Quarter, MEDINOL shall submit to purchase andARIAD a Firm Order for the quantities of API to be delivered to MEDINOL during such Calendar Quarter; provided, when accepted by Patheonhowever, for Patheon to manufacture and deliver that the agreed quantity of the Products. The Delivery Date will API specified in any Firm Order for delivery in a Calendar Quarter shall not be less than [***] following the date that the Firm Order is submitted. Firm Orders submitted to Patheon will specify Client's purchase order number, quantities by Product type, monthly delivery schedule, and any other elements necessary to ensure the timely manufacture and shipment of the Products. The quantities of Products ordered in those written orders will be firm and binding on Client and may not be reduced by Client. Further, for [********] of the percent [(***%)] forecast, Client commits that its Firm Orders for each of those months will be no less nor more than [***], respectively, **************************] percent [(*%)] of the forecasted amounts quantity of API specified in the then-current Forecast for API for such Calendar Quarter delivered on or before the first day of the Calendar Quarter preceding the Calendar Quarter for which the Firm Order is placed (the “then-current Forecast”) (For example, the Firm Order for the third Calendar Quarter of any year must be delivered at least forty-five (45) days before July 1 of such year and cannot be less than [*%] nor more than [*%] of the Forecast for such third Calendar Quarter delivered on or before April 1 of such year); provided that MEDINOL may request excess quantities (i.e., in excess of [***]. If Client orders less than the agreed volume, the parties will meet to discuss how to smooth production to meet demand. If it is not possible to smooth production to meet forecasted demand, Client will compensate Patheon for not meeting the Firm Order commitment by paying the [***********************] for the shortfall between what Client actually ordered and its Firm Order commitment as set forth above or as otherwise provided for in the applicable Product Agreement. The forgoing shall be Patheon’s sole and exclusive remedy for Client’s failure to meet the Firm Order commitment. No amounts shall be payable to Patheon if Client is unable to make the Firm Order commitment because of Force Majeure or because the Product is taken off the market due in response to an action by an Authority or otherwise as required by Applicable Law. Patheon commits to make percent [(***%)] of the forecasted amounts available quantity of API specified in the then-current Forecast). ARIAD shall not be obligated to Client, and will reserve [***] of its capacity supply such excess quantities but shall use good faith efforts to meet that commitmentdo so. Patheon ARIAD shall notify Client as soon as possible MEDINOL, within five (5) days after receipt by ARIAD of impending capacity constraints each Firm Order submitted in relation accordance with this Section 4.2 and shall be obligated to Client’s forecasts and/or changes manufacture and deliver the specified quantity of API in Client’s demandsaccordance with the delivery schedule set forth in such Firm Order. Each Firm Order shall specify the stage of development or commercialization of MEDINOL Licensed Products in which that Batch of API shall be used. ANY ADDITIONAL OR INCONSISTENT TERMS OR CONDITIONS OF ANY PURCHASE ORDER, ACKNOWLEDGMENT OR SIMILAR STANDARDIZED FORM GIVEN OR RECEIVED PURSUANT TO THIS AGREEMENT SHALL HAVE NO EFFECT AND SUCH TERMS AND CONDITIONS ARE HEREBY EXCLUDED.

Appears in 1 contract

Samples: Supply Agreement (Ariad Pharmaceuticals Inc)

Firm Orders. On a rolling basis during (a) From time to time and subject to the term other provisions of the Product this Agreement, Client will issue an updated [***] forecast on or before the [***]. This forecast will start on [***]. Unless otherwise agreed in the Product AgreementJazz Pharmaceuticals shall place its firm orders for API, the first [***] of this updated forecast will be considered binding firm orders. Concurrent with the [***] forecast, Client will issue a new firm written order in the form of a purchase order or otherwise (“Firm Order”) by Client to purchase and, when accepted by Patheon, for Patheon to manufacture and deliver the agreed quantity of the Productsspecifying requested delivery dates. The Delivery Date will delivery dates specified in any such orders shall not be less than [***[ * ] following from the date of such orders. (b) To the extent that firm orders requested for shipment in any quarter exceed the Firm Order is submittedmost recent Jazz Pharmaceuticals forecast for such quarter provided under Section 2.4 by more than [ * ] percent ([ * ]%) (any excess of [ * ] percent ([ * ]%) or less shall, for this purpose, be deemed not to exceed forecast), Solvay shall use its commercially reasonable efforts to accommodate any such excess contained in Jazz Pharmaceuticals’ firm orders, but Solvay shall not be liable to Jazz Pharmaceuticals for any inability, despite its reasonable efforts, to fill orders in excess of such forecast. Firm Orders submitted [ * ] = 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) Solvay shall use commercially reasonable efforts to Patheon will specify Client's purchase order number, quantities by Product type, monthly delivery schedule, and accommodate any other elements necessary to ensure Jazz Pharmaceuticals’ request for the timely manufacture and shipment API in excess of the Products. The quantities of Products ordered described in those written orders will be firm and binding on Client and may not be reduced by Client. Furtherany previously-submitted purchase order, or for [***] delivery of the [***] forecast, Client commits that its Firm Orders for each of those months will be no less API sooner than [***], respectively, of the forecasted amounts for [***]. If Client orders less than the agreed volume, the parties will meet to discuss how to smooth production to meet demand. If it is not possible to smooth production to meet forecasted demand, Client will compensate Patheon for not meeting the Firm Order commitment by paying the [***] for the shortfall between what Client actually ordered and its Firm Order commitment as set forth above or as otherwise provided for in such purchase order. Should Jazz Pharmaceuticals business conditions necessitate reduction or delay in purchase order requirements, then Solvay shall use commercially reasonable efforts to implement such requested changes; provided that [ * ]. Notwithstanding the applicable Product Agreement. The forgoing foregoing, Solvay shall be Patheon’s sole and exclusive remedy for Client’s failure to meet the Firm Order commitment. No amounts shall be payable to Patheon if Client is unable to make the Firm Order commitment because of Force Majeure or because the Product is taken off the market due not take any action in response to an action by an Authority or otherwise as required by Applicable Law. Patheon commits any such requests which would result in charges to make [***] of Jazz Pharmaceuticals in addition to those set forth in the forecasted amounts available to Client, and will reserve [***] of its capacity to meet that commitment. Patheon shall notify Client as soon as possible of impending capacity constraints in relation to Client’s forecasts and/or changes in Client’s demandsrespective purchase order without Jazz Pharmaceuticals’ prior written consent.

Appears in 1 contract

Samples: Supply Agreement (Jazz Pharmaceuticals Inc)

Firm Orders. On a rolling basis during or before the term of the Product Agreement, Client will issue an updated [***] forecast on or before the [* of each ***]. This forecast will start on [***]. Unless otherwise agreed in the Product Agreement, the first [***] of this updated forecast will be considered binding firm orders. Concurrent with the [***] forecast, Client will shall issue a new firm written order in the form of a purchase order or otherwise (“Firm Order”) by Client to purchase and, when accepted by Patheon, for Patheon to manufacture and deliver the agreed quantity Manufacturing in respect of the Products. The Delivery Date will Products to be produced and delivered to the Client on one or more dates not be less than [than***] * from the first day of the calendar month immediately following the date that the Firm Order is submittedsubmitted (each, a “Delivery Date”). Such Firm Orders submitted to Patheon will shall specify the Client's ’s Manufacturing purchase order number, quantities by Product type, monthly delivery schedule, shipment location and any other elements necessary to ensure the timely manufacture production and shipment of the Products. The quantities of Products ordered in those written orders will such Firm Orders shall be firm and binding on Client and may not be reduced by Client. Further, for [***] *. If Client cancels any or part of the [a Firm Order, Client shall be responsible for ***] forecast* of such cancelled part of a Firm Order, provided that if Client commits informs Patheon at any time during the **** of this Agreement, at **** prior to the Delivery Date of any Firm Order, that it would like to cancel any or part of such Firm Order, then ****. ****. Patheon shall indicate its acceptance of Firm Orders for the Product by promptly acknowledging acceptance of each of those months will be no less than [Firm Order in writing within ***]* of its receipt; each such acceptance shall include, respectivelysubject to Client confirmation, the Delivery Date for the Product ordered. The agreed upon Delivery Date may be amended from time to time by written agreement of the forecasted amounts parties, with the newly agreed upon date becoming the new Delivery Date. For the avoidance of doubt, Patheon will accept all Firm Orders submitted by the Client for [Product so long as ***]*. If Client orders less than the agreed volume, the parties will meet to discuss how to smooth production to meet demand. If it is not possible to smooth production to meet forecasted demand, Client will compensate Patheon for not meeting the Firm Order commitment by paying the [***] for the shortfall between what Client actually ordered and its Firm Order commitment as set forth above or as otherwise provided for in the applicable Product Agreement. The forgoing shall be Patheon’s sole and exclusive remedy for Client’s failure to meet the Firm Order commitment. No amounts shall be payable to Patheon if Client is unable to make the Firm Order commitment because of Force Majeure or because the Product is taken off the market due in response to an action by an Authority or otherwise as required by Applicable Law. Patheon commits to make [* ***] of the forecasted amounts available to Client, and will reserve [*CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. ***] *. All Firm Orders will be deemed to incorporate all of its capacity to meet that commitment. Patheon shall notify Client as soon as possible of impending capacity constraints the terms and conditions in relation to Client’s forecasts and/or changes in Client’s demandsthis Agreement.

Appears in 1 contract

Samples: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)

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Firm Orders. On a rolling basis during or before the term of the Product Agreement, Client will issue an updated [***] forecast on or before the [* of each ***]. This forecast will start on [***]. Unless otherwise agreed in the Product Agreement, the first [***] of this updated forecast will be considered binding firm orders. Concurrent with the [***] forecast, Client will shall issue a new firm written order in the form of a purchase order or otherwise (“Firm Order”) by Client to purchase and, when accepted by Patheon, for Patheon to manufacture and deliver the agreed quantity Manufacturing in respect of the Products. The Delivery Date will Products to be produced and released to the Client on one (1) or more dates not be less than [***] * from the first day of the calendar month immediately following the date that the Firm Order is submittedsubmitted (each, a “Delivery Date”). For clarity, Products will be placed at Client’s disposal for collection by Client’s carrier on the date of release by Patheon Quality Control. Such date of Patheon Quality Control release shall be deemed to be the Delivery Date. Such Firm Orders submitted to Patheon will shall specify the Client's ’s Manufacturing purchase order number, quantities by Product type, monthly delivery schedule, shipment location and any other elements necessary to ensure the timely manufacture production and shipment of the Products. The quantities of Products ordered in those written orders will such Firm Orders shall be firm and binding on Client and may not be reduced by Client. Further, for [***] of *. In the [event that Client cancels ***] forecast* CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. any or part of a Firm Order, Client commits shall be responsible for **** of such cancelled part of a Firm Order, provided that if Client informs Patheon at any time during the **** of this Agreement, at **** prior to the commencement of dispensing, that it would like to cancel any or part of such Firm Order, then ****. Patheon shall indicate its acceptance of Firm Orders for the Product by promptly acknowledging acceptance of each of those months will be no less than [Firm Order in writing within ***]* of its receipt; each such acceptance shall include, respectivelysubject to Client confirmation, the Delivery Date for the Product ordered. The agreed upon Delivery Date may be amended from time to time by written agreement of the forecasted amounts parties, with the newly agreed upon date becoming the new Delivery Date. For the avoidance of doubt, Patheon will accept all Firm Orders submitted by the Client for [Product so long as ***]*. If Client orders less than the agreed volume, the parties All Firm Orders will meet be deemed to discuss how to smooth production to meet demand. If it is not possible to smooth production to meet forecasted demand, Client will compensate Patheon for not meeting the Firm Order commitment by paying the [***] for the shortfall between what Client actually ordered and its Firm Order commitment as set forth above or as otherwise provided for in the applicable Product Agreement. The forgoing shall be Patheon’s sole and exclusive remedy for Client’s failure to meet the Firm Order commitment. No amounts shall be payable to Patheon if Client is unable to make the Firm Order commitment because of Force Majeure or because the Product is taken off the market due in response to an action by an Authority or otherwise as required by Applicable Law. Patheon commits to make [***] incorporate all of the forecasted amounts available to Client, terms and will reserve [***] of its capacity to meet that commitment. Patheon shall notify Client as soon as possible of impending capacity constraints conditions in relation to Client’s forecasts and/or changes in Client’s demandsthis Agreement.

Appears in 1 contract

Samples: Manufacturing Agreement (Vanda Pharmaceuticals Inc.)

Firm Orders. On (i) The forecast for each Q1 of each Quarterly Update shall constitute a rolling basis firm order (“Firm Order”) for Packaged Product and Purchaser shall be obligated to purchase, and API shall be obligated to supply, such quantities and types of Packaged Products pursuant to one or more Purchase Orders submitted to API during such Quarter. The Firm Order shall be binding on Purchaser, and API shall have the term right to rely upon the Firm Order, with respect to API’s orders and purchases of the Product Agreement, Client will issue Packaging Materials that are required to fill such Firm Order and that require an updated [***] forecast on or before the ordering lead time of less than [***]. This forecast will start on Additionally, API shall have the right to rely upon the Quarterly Update, with respect to API’s orders and purchases of Packaging Materials that require an ordering lead time of more than [***]] as more particularly described on Appendix 4 attached hereto and as may be amended from time to time (“Long Lead Time Components”); provided, however, that API may only rely on the Quarterly Update for its purchases of Long Lead Time Components to the extent necessary to meet the lead times required for such Long Lead Time Components. Unless otherwise Any change to Appendix 4 after the date of this Agreement shall be mutually agreed upon by the parties and shall be signed by a representative of each party. Notwithstanding anything in this Agreement to the Product Agreementcontrary, the first Quarterly Update shall not be binding on Purchaser, and API may not rely upon the Quarterly Update, for orders or purchases of Packaging Materials other than Long Lead Time Components as described in this Section 6(c)(i) above. (ii) It is understood and agreed that Purchaser shall not be obligated to purchase and API shall not be obligated to produce the forecasted quantities of Packaged Product for the final [***] of this updated each Quarterly Update until such forecasted quantities become a Firm Order pursuant to Section 6(c)(i) above, and such forecast will shall not be considered binding firm orders. Concurrent upon Purchaser in any respect, and Purchaser shall not be liable with the [***] forecastrespect to its good faith efforts to provide such non-binding forecasts except, Client will issue a new firm written order in the form of a purchase order or otherwise (“Firm Order”) by Client to purchase and, when accepted by Patheoneach case, for Patheon Purchaser’s obligations with respect to manufacture API’s orders and deliver purchases of Long Time Lead Components described in Section 6(c)(i) above and Section 6(e)(ii) below. Notwithstanding the agreed quantity of foregoing, the Products. The Delivery Date will Firm Order for the then current Calendar Quarter may not be for an amount less than [***] following the date that the Firm Order is submitted. Firm Orders submitted to Patheon will specify Client's purchase order number, quantities by Product type, monthly delivery schedule, and any other elements necessary to ensure the timely manufacture and shipment of the Products. The quantities of Products ordered in those written orders will be firm immediately preceding quarterly forecast for such Calendar Quarter and binding on Client and may API shall not be reduced by Client. Further, for obligated to supply more than [***] of the [***] forecastsuch forecasted amount, Client commits that its Firm Orders for in each of those months will be no less than [***], respectively, of the forecasted amounts for [***]. If Client orders less than the case unless otherwise agreed volume, by the parties will meet in writing, subject to discuss how to smooth production to meet demand. If it is not possible to smooth production to meet forecasted demand, Client will compensate Patheon for not meeting the Firm Order commitment by paying the [***] for the shortfall between what Client actually ordered and its Firm Order commitment as set forth above or as otherwise provided for in the applicable Product Agreement. The forgoing shall be Patheon’s sole and exclusive remedy for Client’s failure to meet the Firm Order commitment. No amounts shall be payable to Patheon if Client is unable to make the Firm Order commitment because of Force Majeure or because the Product is taken off the market due in response to an action by an Authority or otherwise as required by Applicable Law. Patheon commits to make [***] of the forecasted amounts available to Client, and will reserve [***] of its capacity to meet that commitment. Patheon shall notify Client as soon as possible of impending capacity constraints in relation to Client’s forecasts and/or changes in Client’s demandsSection 6(e) below.

Appears in 1 contract

Samples: Packaging and Supply Agreement (Transcept Pharmaceuticals Inc)

Firm Orders. On a rolling basis during the term of the Product Agreement, Client will issue an updated [***] forecast on or before the [***]. This forecast will start on [***]. Unless otherwise agreed (a) As provided in the Product AgreementSection 3.2(a) above, the first [***] of this updated forecast will each Constrained Forecast submitted by Buyer shall constitute binding commitments by Buyer to submit firm orders (each, a “Firm Order”) to purchase the amount of Product or 2.5 mg Dosage Strength, as applicable, forecasted to be considered binding firm ordersordered in each such month (subject to the following). Concurrent Buyer, on a monthly basis, shall deliver orders to Seller for Supplied Product in the amounts consistent with the [***] forecast, Client will issue a new firm written order applicable Firm Order in the form of a written purchase order or otherwise order, stating (“Firm Order”i) by Client to purchase and, when accepted by Patheon, for Patheon to manufacture and deliver the agreed quantity of Supplied Product ordered; and (ii) the Products. The Delivery Date will not requested delivery date thereof; provided, however, that, in no event shall the requested delivery date be less than [***] following from the date that the of Buyer’s order thereof. Each Firm Order is submittedsubmitted by Buyer shall be binding on Seller. Firm Orders submitted to Patheon will specify Client's purchase order number, quantities by Product type, monthly delivery schedule, and any other elements necessary to ensure the timely manufacture and shipment of the Products. The All quantities of Products each Supplied Product ordered in those written orders will by Buyer shall be firm and binding on Client and may not be reduced by Client. Further, for [***] of the [***] forecast, Client commits that its Firm Orders for each of those months will be no less than [***], respectively, of the forecasted amounts for [***]. If Client orders less than In the agreed volumeevent of any inconsistency between the terms and conditions of any purchase order delivered under this Agreement and the terms and conditions of this Agreement, the parties will meet to discuss how to smooth production to meet demand. If it is not possible to smooth production to meet forecasted demandterms and conditions of this Agreement shall prevail. (b) Notwithstanding the order size limitations of Sections 3.2(b) and 3.3(a) above, Client will compensate Patheon Buyer may, in any particular month, submit orders for not meeting amounts of Supplied Product in excess of the Firm Order commitment by paying the [***] amount for the shortfall between what Client actually ordered and its Firm Order commitment such month (as set forth above or as otherwise provided for in the applicable constraints set forth in Section 3.2(b) or 3.3(a)). Seller shall use all commercially reasonable efforts to supply such excess quantity of Supplied Product Agreementordered. The forgoing If unable to supply the entire amount of such excess order, Seller shall be Patheon’s sole and exclusive remedy for Client’s failure supply such lesser quantity of Supplied Product as it is able to meet using such efforts, but Seller shall have no liability hereunder to Buyer to the Firm Order commitment. No amounts shall be payable to Patheon if Client extent Seller is unable to make supply such excess orders notwithstanding its using such efforts. (c) On the Firm Order commitment because Effective Date, Buyer is delivering an order to Seller for the Closing Inventory in the form of Force Majeure a written purchase order. Notwithstanding anything in Section 4.4(a) to the contrary, the Closing Inventory shall be delivered to Buyer (or because its designee) pursuant to the Product is taken off the market due in response to an action by an Authority or otherwise as required by Applicable Law. Patheon commits to make [***] of the forecasted amounts available to Client, and will reserve [***] of its capacity to meet that commitment. Patheon shall notify Client as soon as possible of impending capacity constraints in relation to Client’s forecasts and/or changes in Client’s demandsTransition Services Agreement.

Appears in 1 contract

Samples: Supply Agreement (Forest Laboratories Inc)

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