Forecasts and Orders. 3.1 Forecasting and ordering of Product(s) under this Agreement shall be conducted: (A) on a pull Manufacturing basis in respect of the Products as set out in clauses 3.2 and 3.4; or (B) on a Toll Manufacturing Basis in respect of Products that are Tolled Products as set out in clause 5 (Toll Manufacture) and Exhibit 7 (Toll Manufacturing Provisions), and (C) on the fifth (5th) Business Day of each calendar month commencing not later than the calendar month following the calendar month in which the Effective Date falls (or at such other dates as may be agreed between the Parties), the Purchaser shall provide to the Supplier a rolling demand forecast schedule (in such physical written format (as opposed to a data exchange) exchangeable by email as is agreed by the Parties) which shall align with the applicable Gating Plan for that Gating Year and comprise a good faith estimate of its anticipated aggregate monthly requirements for Products for at least the following twenty-four (24) months or, in each case, such shorter period remaining under the Term (including any proposed extension thereof), in accordance with clause 3.2 ( the “Forecast Schedule”). (A) Manufacturing and supply of Products under this Agreement shall be pursuant to the Forecast Schedules and to the Firm Orders submitted by the Purchaser, as further described in this clause 3.2. (B) The initial Forecast Schedule is attached to this Agreement at Exhibit 14 (Initial Product Forecast Schedule) and the Parties agree that the Purchaser and the Supplier shall be bound by the volumes of Products shown in the Firm Zone of such initial Forecast Schedule as at the Effective Date. The initial Forecast Schedule shall reflect the migration of all orders that are in progress immediately prior to the Effective Date. (C) Provided that the volumes of Products shown in the Firm Zone of each Forecast Schedule align with the requirements of the Gating Plan in respect of such Products, such volumes shall be deemed to be firm orders binding on the Purchaser and the Supplier, and the quantities included for each Product in any Firm Zone may not be varied in any subsequent Forecast Schedule unless the Supplier agrees in writing (each such firm order being a “Firm Order”). Each Firm Order shall be for not less than the Minimum Order Quantity of Product and, if greater than the Minimum Order Quantity, shall be for the Minimum Order Quantity plus one or more multiples of the Minimum Order Quantity. If the volumes specified in the Firm Order do not comply with this requirement then such variation to such volumes must be agreed between the Parties as part of the Firm Order confirmation process set out at 3.2(E). (D) The Purchaser shall submit each Forecast Schedule either electronically or by such other means that the Manufacturing and Supply Team shall determine and to such location as reasonably requested by the Supplier in writing. No oral communications shall comprise a commitment to supply. Each Firm Order shall specify the volumes of Product required and the Purchaser’s requested Delivery date in accordance with the applicable Lead Time requirements as set out in Exhibit 1 (Products). (E) The Supplier shall respond to each Firm Order that complies with the requirements of this clause 3.2 (including the applicable Gating Plan): (i) within two (2) Business Days of receipt (or such other date as agreed between the Parties) to acknowledge receipt of the Firm Order; and (ii) within ten (10) Business Days of receipt (or such other date as agreed between the Parties) to confirm the applicable order Delivery date and the volumes of Product required. In the event that the Supplier fails to respond to any Firm Order within ten (10) Business Days after acknowledging it, the Supplier shall be deemed to have acknowledged and accepted that Firm Order. Unless otherwise agreed by the Parties, the Supplier shall be obliged to acknowledge Firm Orders which comply with the requirements of this clause 3.2 without proposed amendments. The response (or deemed response) will include confirmation of the Delivery date. To the extent that the Supplier proposes an amendment to the Firm Order, the Purchaser shall respond to any proposed amendments to the Firm Order within ten (10) Business Days confirming whether it accepts or rejects such proposed amendments. If the Purchaser: (iii) accepts such amendments, the Firm Order together with the relevant amendments shall be deemed to be acknowledged and accepted by the Supplier and shall be binding on both Parties; or (iv) rejects such proposed amendments; the Parties will discuss the proposed amendments in good faith as promptly as practicable, but not more than five (5) Business Days following such rejection. The Parties agree that if the Parties cannot agree an amendment to the Firm Order pursuant to this clause 3.2(E) that the Firm Order initially submitted without the suggested amendments shall be binding on the Parties to the extent it is in accordance with this clause 3.2 and the applicable Gating Plan, provided that the Supplier may refer the matter for resolution in accordance with clause
Appears in 1 contract
Forecasts and Orders. 3.1 Forecasting 7.7.1. Not less than [*] prior to the first day of each Calendar Quarter (commencing with the first Calendar Quarter in which IMMEDICA orders Unlabeled Product from the LICENSOR hereunder), IMMEDICA shall prepare and ordering provide the LICENSOR with a written forecast of Product(s) its good faith estimated requirements for Unlabeled Product for each of the [*] (each a “Forecast”). IMMEDICA shall not increase or decrease the quantity estimated for [*]. The quantities estimated for all subsequent quarterly periods of each Forecast shall be non-binding, and for planning purposes only. [*] IMMEDICA shall, in good faith, seek to limit its orders such that in any calendar year, it submits its entire year’s demand across [*] purchase orders.
7.7.2. IMMEDICA shall be required to purchase, and the LICENSOR shall be required to supply, [*] of the quantity of Unlabeled Product forecast in the [*] of each Forecast.
7.7.3. The LICENSOR shall be required to supply the quantity of Unlabeled Product ordered by IMMEDICA under this Agreement shall be conducted:
(A) on a pull Manufacturing basis Section 7.7 in respect any Calendar Quarter up to the quantity forecasted for the [*] of the Products as set out most recent Forecast. If IMMEDICA’s orders in clauses 3.2 and 3.4; or
(B) on a Toll Manufacturing Basis in respect any Calendar Quarter exceeds the quantity forecasted for the [*] of Products that are Tolled Products as set out in clause 5 (Toll Manufacture) and Exhibit 7 (Toll Manufacturing Provisions), and
(C) on the fifth (5th) Business Day of each calendar month commencing not later than the calendar month following the calendar month in which the Effective Date falls (or at such other dates as may be agreed between the Parties)most recent Forecast, the Purchaser LICENSOR shall provide use Commercially Reasonable Efforts to the Supplier a rolling demand forecast schedule (in supply such physical written format (as opposed excess. The LICENSOR shall use Commercially Reasonable Efforts to a data exchange) exchangeable by email as is agreed by the Parties) which shall align with the applicable Gating Plan for that Gating Year and comprise a good faith estimate of its anticipated aggregate monthly meet IMMEDICA’s delivery requirements for Products for at least the following twenty-four (24) months or, in each case, such shorter period remaining under the Term (including any proposed extension thereof), specified in accordance with clause 3.2 ( Section 7.7.4. In the “Forecast Schedule”)event of a shortfall, the LICENSOR shall promptly inform IMMEDICA and use Commercially Reasonable Efforts to apportion Unlabeled Product among IMMEDICA, the LICENSOR, and its other customers on a [*] according to their respective forecasts for the relevant period, provided always that such forecasts were proposed in good faith.
(A) Manufacturing and supply of Products 7.7.4. IMMEDICA shall make all purchases under this Agreement Section 7.7 by submitting firm purchase orders to the LICENSOR. Each such purchase order shall be pursuant in writing in a form reasonably acceptable to the Forecast Schedules and to the Firm Orders submitted by the Purchaser, as further described in this clause 3.2.
(B) The initial Forecast Schedule is attached to this Agreement at Exhibit 14 (Initial Product Forecast Schedule) and the Parties agree that the Purchaser and the Supplier shall be bound by the volumes of Products shown in the Firm Zone of such initial Forecast Schedule as at the Effective Date. The initial Forecast Schedule shall reflect the migration of all orders that are in progress immediately prior to the Effective Date.
(C) Provided that the volumes of Products shown in the Firm Zone of each Forecast Schedule align with the requirements of the Gating Plan in respect of such Products, such volumes shall be deemed to be firm orders binding on the Purchaser and the SupplierLICENSOR, and the quantities included for each Product in any Firm Zone may not be varied in any subsequent Forecast Schedule unless the Supplier agrees in writing (each such firm order being a “Firm Order”). Each Firm Order shall be for not less than the Minimum Order Quantity of Product and, if greater than the Minimum Order Quantity, shall be for the Minimum Order Quantity plus one or more multiples of the Minimum Order Quantity. If the volumes specified in the Firm Order do not comply with this requirement then such variation to such volumes must be agreed between the Parties as part of the Firm Order confirmation process set out at 3.2(E).
(D) The Purchaser shall submit each Forecast Schedule either electronically or by such other means that the Manufacturing and Supply Team shall determine and to such location as reasonably requested by the Supplier in writing. No oral communications shall comprise a commitment to supply. Each Firm Order shall specify the volumes quantity of Unlabeled Product required ordered, the place of delivery and the Purchaser’s requested Delivery required delivery date therefor, which shall [*] after the date of such purchase order. In addition, IMMEDICA will specify the extent to which any Unlabeled Product should be supplied at a [*], in accordance with order to extend the applicable Lead Time requirements as set out in Exhibit 1 (Products).
(E) The Supplier shall respond to each Firm Order that complies with the requirements of this clause 3.2 (including the applicable Gating Plan):
(i) within two (2) Business Days of receipt (or such other date as agreed between the Parties) to acknowledge receipt shelf-life of the Firm Order; and
Product to [*] (ii) within ten (10) Business Days of receipt (or such other date as agreed between the Parties) to confirm the applicable order Delivery date and the volumes of Product required“[*]”). In the event that the Supplier fails to respond to any Firm Order within ten (10) Business Days after acknowledging it[*] is ordered, the Supplier it shall be deemed to have acknowledged and accepted that Firm Order. Unless otherwise agreed prioritized by the Parties, LICENSOR such that the Supplier first order the LICENSOR delivers after a new manufacturing run has been completed shall be obliged to acknowledge Firm Orders which comply with the [*] ordered by IMMEDICA. Upon receipt of a purchase order reflecting the requirements of this clause 3.2 without proposed amendments. The response (or deemed response) will include confirmation of the Delivery date. To the extent that the Supplier proposes an amendment to the Firm Order, the Purchaser shall respond to any proposed amendments to the Firm Order within ten (10) Business Days confirming whether it accepts or rejects such proposed amendments. If the Purchaser:
(iii) accepts such amendments, the Firm Order together with the relevant amendments shall be deemed to be acknowledged and accepted Section 7.7.4 by the Supplier and LICENSOR, such purchase order shall be binding on both Parties; or
. Notwithstanding the foregoing, if IMMEDICA places an order for delivery of Unlabeled Product and the requested delivery date is [*] after the last manufacturing run has been completed by the LICENSOR, then the LICENSOR may notify IMMEDICA in writing that such Unlabeled Product may not be able to comply with the minimum shelf-life requirements set out in Section 7.9.1, and what the remaining shelf-life of such Unlabeled Product would be (iv) rejects “Short-Dated Product”). In such proposed amendments; the Parties will discuss the proposed amendments in good faith as promptly as practicablecircumstances, but if IMMEDICA chooses to proceed with such order, it shall not more than five (5) Business Days following such rejection. The Parties agree that be a breach of Section 7.9.1 if the Parties canUnlabeled Product delivered by LICENSOR to IMMEDICA does not agree an amendment have the minimum shelf-life requirements, provided it has the remaining shelf-life advised by the LICENSOR at the time that IMMEIDCA chooses to proceed with the Firm Order pursuant order. If IMMEDICA chooses not to this clause 3.2(E) that proceed with such order, then such purchase order shall automatically be cancelled and shall not be binding on the Firm Order initially submitted without the suggested amendments Parties. No additional terms of any such purchase order shall be binding on the Parties LICENSOR and are expressly rejected hereby. In the event of a conflict between the terms and conditions of any purchase order and this Agreement, the terms and conditions of this Agreement shall prevail. IMMEDICA shall, in good faith, coordinate with LICENSOR to minimize placing orders with a requested delivery date after the extent it is in accordance with this clause 3.2 and first [*] of the applicable Gating Plan, provided that the Supplier may refer the matter for resolution in accordance with clausemanufacturing run.
Appears in 1 contract
Samples: License and Supply Agreement (Aeglea BioTherapeutics, Inc.)
Forecasts and Orders. 3.1 Forecasting (a) ABBI agrees to provide Forecasts, Firm Forecasts and ordering of Product(s) under this Agreement shall be conducted:
(A) on a pull Manufacturing basis in respect of the Products as set out in clauses 3.2 and 3.4; or
(B) on a Toll Manufacturing Basis in respect of Products that are Tolled Products as set out in clause 5 (Toll Manufacture) and Exhibit 7 (Toll Manufacturing Provisions), and
(C) on the fifth (5th) Business Day of each calendar month commencing not later than the calendar month following the calendar month in which the Effective Date falls (or at such other dates as may be agreed between the Parties), the Purchaser shall provide to the Supplier a rolling demand forecast schedule (in such physical written format (as opposed to a data exchange) exchangeable by email as is agreed by the Parties) which shall align with the applicable Gating Plan for that Gating Year and comprise a good faith estimate of its anticipated aggregate monthly requirements Firm Orders for Products in whole batch increments for at least the following twenty-four each Product by National Drug Code (24“NDC”) months or, in each case, such shorter period remaining under the Term (including any proposed extension thereof), in accordance with clause 3.2 ( the “Forecast Schedule”).
(A) Manufacturing and supply of procedures set forth in this Section 2.4. AZ shall use commercially reasonable efforts to deliver Products under this Agreement shall be pursuant to the Forecast Schedules and to ordered in accordance with timelines set forth in the Firm Orders submitted by the Purchaser, as further described ABBI in accordance with this clause 3.2Section 2.4.
(Bb) The ABBI shall submit an initial Forecast Schedule is attached to firm order (“Initial Firm Order”) upon execution of this Agreement at Exhibit 14 (Initial Product Forecast Schedule) for the entire inventory of the Products in final form and the Parties agree that the Purchaser and the Supplier shall be bound by the volumes of Products shown labeled for sale in the Firm Zone Territory then held by AZ anywhere in the world on and as of such initial Forecast Schedule date. The Initial Firm Order shall not specify a delivery date that is not [***] from the date of this Agreement. AZ and ABBI agree that, as at part of the Initial Firm Order, AZ shall supply to ABBI, not less than a [***], based on the [***] and that, notwithstanding the preceding sentence, such amount of [***] will be delivered on the delivery date specified in the Initial Firm Order or as soon thereafter as is commercially reasonable. The cost of that part of the Initial Firm Order that consists of [***] is included in the Purchase Price (as defined in the Asset Purchase Agreement), and ABBI shall only be obligated to pay for the other Products included in the Initial Firm Order in accordance with Section 5 of this Agreement.
(c) Within two business days following the Effective Date, or on such other date as may be agreed to by the Parties in writing, ABBI shall provide to AZ a non-binding forecast of ABBI ‘s requirements for each Product by NDC for a [***] (a “Forecast”). The initial Such Forecast Schedule shall reflect be revised quarterly for a rolling [***] period and delivered to AZ on the migration first day of all orders that are in progress immediately prior to each calendar quarter. In addition, for the purposes of AZ’s long-term planning, ABBI shall provide a non-binding best estimate of a [***] forecast of its anticipated quarterly requirements for each Product by NDC, which shall be updated on an annual basis on the anniversary of the Effective DateDate of this Agreement.
(Cd) Provided that Within ten (10) business days after the volumes Effective Date of Products shown in the Firm Zone of each Forecast Schedule align with the requirements of the Gating Plan in respect of such Productsthis Agreement, such volumes ABBI shall be deemed submit to be firm orders binding on the Purchaser and the Supplier, and the quantities included for each Product in any Firm Zone may not be varied in any subsequent Forecast Schedule unless the Supplier agrees in writing AZ a non-cancelable purchase order (each such firm order being a “Firm Order”) for ABBI’s orders of Products by NDC to be delivered during the remainder of the current calendar quarter and the following first full calendar quarter. Thereafter, ABBI shall submit a Firm Order no later than the first day of each calendar quarter for all of ABBI’s orders of Products by NDC to be delivered in the following calendar quarter. ABBI shall also submit to AZ along with such Firm Order a forecast for the next calendar quarter following the quarter to which the Firm Order applies (a “Firm Forecast”). Each (See Schedule E attached hereto.) The volume set forth in any Firm Order may not deviate more than [***] for each Product by NDC from the Firm Forecast submitted to AZ by ABBI for such calendar quarter.
(e) AZ will respond within [***] of receiving each of ABBI’s quarterly rolling Forecast, Firm Forecast and Firm Order, and will either (i) confirm acceptance by AZ of the Forecast, Firm Forecast and Firm Order quantities or (ii) reject the requested quantities and initiate dialogue between the Parties to arrive at mutually acceptable values for the Forecast, Firm Forecast and Firm Order. AZ will use commercially reasonable efforts to accommodate any additional quantity of Products requested by ABBI after the Firm Order has been submitted to AZ, but AZ shall not be liable in any respect for not its inability to do so. Notwithstanding anything in this Agreement to the contrary, AZ shall have no obligation to supply more than [***] of the aggregate volume of each Product by NDC for such calendar quarter set forth in any Firm Forecast. Firm Orders may be amended only by mutual agreement of the Parties, in writing. Furthermore, in the event that ABBI submits a Firm Order for a volume that is less than the Minimum Order Quantity of Product and, if greater than the Minimum Order Quantity, shall be for the Minimum Order Quantity plus one or more multiples [***] of the Minimum Order Quantity. If the volumes specified volume of any Product(s) by NDC indicated in the Firm Order do not comply with this requirement Forecast for such calendar quarter, and AZ elects to accept such Firm Order, then AZ shall use commercially reasonable efforts to utilize excess Components, Materials and Work in Process as a result of such variation to such volumes must be agreed between the Parties as part of the Firm Order confirmation process set out at 3.2(E).
(D) The Purchaser shall submit each Forecast Schedule either electronically or by such other means that the Manufacturing and Supply Team shall determine and to such location as reasonably requested by the Supplier in writing. No oral communications shall comprise a commitment to supply. Each Firm Order shall specify the volumes of Product required and the Purchaser’s requested Delivery date in accordance with the applicable Lead Time requirements as set out in Exhibit 1 (Products).
(E) The Supplier shall respond to each Firm Order that complies with order shortfall for the requirements of other Affiliates of AZ or for future periods covered by this clause 3.2 (including the applicable Gating Plan):
(i) within two (2) Business Days of receipt (or such other date as agreed between the Parties) to acknowledge receipt of the Firm Order; and
(ii) within ten (10) Business Days of receipt (or such other date as agreed between the Parties) to confirm the applicable order Delivery date and the volumes of Product required. In the event that the Supplier fails to respond to any Firm Order within ten (10) Business Days after acknowledging it, the Supplier shall be deemed to have acknowledged and accepted that Firm Order. Unless otherwise agreed by the Parties, the Supplier shall be obliged to acknowledge Firm Orders which comply with the requirements of this clause 3.2 without proposed amendments. The response (or deemed response) will include confirmation of the Delivery date. To the extent that the Supplier proposes an amendment to the Firm Order, the Purchaser shall respond to any proposed amendments to the Firm Order within ten (10) Business Days confirming whether it accepts or rejects such proposed amendmentsAgreement. If AZ is unable to utilize such Components, Materials and Work in Process, then in such case (and only in such case) AZ shall have the Purchaser:
(iii) accepts right to invoice ABBI for the cost of all Components, Materials and Work in Progress that AZ discarded as a result of such amendments, the Firm Order together with the relevant amendments shall be deemed to be acknowledged and accepted by the Supplier and shall be binding on both Parties; or
(iv) rejects such proposed amendments; the Parties will discuss the proposed amendments in good faith as promptly as practicable, but not more than five (5) Business Days following such rejection. The Parties agree that if the Parties cannot agree an amendment to the Firm Order pursuant to this clause 3.2(E) that the Firm Order initially submitted without the suggested amendments shall be binding on the Parties to the extent it is in accordance with this clause 3.2 and the applicable Gating Plan, provided that the Supplier may refer the matter for resolution in accordance with clauseorder shortfall.
Appears in 1 contract
Samples: Manufacturing and Supply Agreement (Abraxis BioScience, Inc.)
Forecasts and Orders. 3.1 Forecasting and ordering of Product(s(a) under this Agreement shall be conducted:Lucent agrees to provide forecasts to Agere in accordance with Schedule 1.2.
(Ab) on a pull Manufacturing basis in respect Any order submitted by Lucent shall contain all information necessary for the furnishing of the Products as set out in clauses 3.2 and 3.4; or
Licensed Materials, including, without limitation, the date of the order, the shipping destination (B) on whether a Toll Manufacturing Basis in respect of Products that are Tolled Products as set out in clause 5 (Toll Manufacture) and Exhibit 7 (Toll Manufacturing ProvisionsLucent location or a Drop Ship Order), and
(C) on proposal or quotation number, if any, and any comcode or other applicable Product identifier. If any proposed schedules and dates, including shipment dates, for the fifth (5th) Business Day furnishing of each calendar month commencing not later than the calendar month following the calendar month Products and Licensed Materials differs from any lead times set forth herein or such shorter standard lead times as Agere may publish from time to time, such schedule must be expressly agreed to in which the Effective Date falls (writing by Agere prior to or at such other dates as may be agreed between the Parties), the Purchaser shall provide to the Supplier a rolling demand forecast schedule (in such physical written format (as opposed to a data exchange) exchangeable by email as is agreed by the Parties) which shall align with the applicable Gating Plan for that Gating Year and comprise a good faith estimate part of its anticipated aggregate monthly requirements for Products for at least acceptance of the following twenty-four (24) months or, in each case, such shorter period remaining under the Term (including any proposed extension thereof), in accordance with clause 3.2 ( the “Forecast Schedule”).
(A) Manufacturing and supply of Products under this Agreement shall be pursuant to the Forecast Schedules and to the Firm Orders order. All orders submitted by the Purchaser, as further described in this clause 3.2.
(B) The initial Forecast Schedule is attached to this Agreement at Exhibit 14 (Initial Product Forecast Schedule) and the Parties agree that the Purchaser and the Supplier shall be bound by the volumes of Products shown in the Firm Zone of such initial Forecast Schedule as at the Effective Date. The initial Forecast Schedule shall reflect the migration of all orders that are in progress immediately prior to the Effective Date.
(C) Provided that the volumes of Products shown in the Firm Zone of each Forecast Schedule align with the requirements of the Gating Plan in respect of such Products, such volumes Lucent shall be deemed to incorporate and be firm orders binding subject to the terms and conditions of this Agreement as well as any supplemental terms and conditions agreed to by authorized representatives of the parties in writing prior to placement of the order. All other terms and conditions contained on any electronic transmission, purchase order form, or correspondence originated by either party are rejected and shall be void and without effect notwithstanding acceptance of an order by Agere unless separately agreed to in a writing.
(c) Agere may use either new, reconditioned, refurbished or remanufactured Products or parts in the Purchaser furnishing of spares, replacement parts, or repairs of Products or Licensed Materials furnished under this Agreement. Agere shall provide new Products and the Supplier, Licensed Materials for initial sale.
(d) Agere shall accept and the quantities included for each Product in any Firm Zone may not be varied in any subsequent Forecast Schedule unless the Supplier agrees acknowledge in writing (each such firm order being a “Firm Order”)or electronically) all Orders submitted by Lucent within five (5) business days after receipt thereof or indicate why an Order cannot be accepted. Each Firm Order shall be for not less than the Minimum Order Quantity Agere will promptly notify Lucent of Product and, if greater than the Minimum Order Quantity, shall be for the Minimum Order Quantity plus one or more multiples any delays that will postpone its promised shipment date of the Minimum Order Quantity. If the volumes specified in the Firm Order do not comply with this requirement then such variation to such volumes must be agreed between the Parties as part of the Firm Order confirmation process set out at 3.2(E).
(D) The Purchaser shall submit each Forecast Schedule either electronically or by such other means that the Manufacturing and Supply Team shall determine and to such location as reasonably requested by the Supplier in writing. No oral communications shall comprise a commitment to supply. Each Firm Order shall specify the volumes of Product required and the Purchaser’s requested Delivery date in accordance with the applicable Lead Time requirements as set out in Exhibit 1 (Products).
(E) The Supplier shall respond to each Firm Order that complies with the requirements of this clause 3.2 (including the applicable Gating Plan):
(i) within two (2) Business Days of receipt (or such other date as agreed between the Parties) to acknowledge receipt of the Firm Order; and
(ii) within ten (10) Business Days of receipt (or such other date as agreed between the Parties) to confirm the applicable order Delivery date and the volumes of Product requiredany accepted order. In the event that the Supplier fails to respond to any Firm an Order within ten (10) Business Days after acknowledging it, the Supplier shall be deemed to have acknowledged and accepted that Firm Order. Unless otherwise agreed by the Parties, the Supplier shall be obliged to acknowledge Firm Orders which comply does not conform with the requirements terms of this clause 3.2 without proposed amendmentsAgreement or is in Agere's reasonable judgment defective, Agere may accept or reject the non-conforming order, either in whole or in part (unless the order states that it must be accepted in its entirety). The response (Agere will not be held responsible or deemed response) will include confirmation liable for any loss or damage arising from its failure to accept any non-conforming orders of the Delivery date. To the extent that the Supplier proposes an amendment to the Firm Order, the Purchaser shall respond to any proposed amendments to the Firm Order within ten (10) Business Days confirming whether it accepts or rejects such proposed amendments. If the Purchaser:Lucent.
(iiie) accepts such amendmentsLucent will not "flow through" to Agere U.S. Government Contracting Provisions (DARS, the Firm Order together with the relevant amendments shall be deemed to be acknowledged and accepted by the Supplier and shall be binding on both Parties; or
(ivFARS, etc.) rejects such proposed amendments; the Parties will discuss the proposed amendments in good faith as promptly as practicable, but not more than five (5) Business Days following such rejection. The Parties agree that if the Parties cannot agree an amendment to the Firm Order pursuant to this clause 3.2(E) that the Firm Order initially submitted without the suggested amendments shall be binding on the Parties to the extent it is in accordance with this clause 3.2 and the applicable Gating Plan, provided that the Supplier may refer the matter for resolution in accordance with clauseprior written acceptance of same from Agere.
Appears in 1 contract
Forecasts and Orders. 3.1 Forecasting (a) Buyer has provided Sellers with a non-binding forecast of its purchases of Products for the Term within the Territory, said forecast being attached hereto as EXHIBIT B.
(b) Within ten (10) business days of the Effective Date, Buyer shall update the forecast described in Paragraph 4.1
(a) Such amended forecast shall be a non-binding (except as provided in Paragraph 14.1(c)) forecast of their purchases of Products for the Term within the Territory ("Annual Forecast"). Each Product is to be identified in such Annual Forecast by individual SKU.
(a) Every thirty (30) days during the term hereof, Buyer shall provide Sellers with a good faith, non-binding forecast of its purchases of Products during the next three (3) month period. Such forecasts shall be made recognizing the requirements for Batch Sizes and ordering Lead Times as defined in Paragraph 4.2(b) hereof.
(b) Sellers have presented Buyers with, and Buyers acknowledge the receipt of, a document listing the Products, the batch size used in the production of Product(seach such Product ("Batch Size"), and the lead times required to manufacture each of said Products ("Lead Times"), such document being appended hereto as EXHIBIT D.
(a) under Buyers shall authorize the manufacture and packaging of a Product by issuing a purchase order ("Purchase Order") to Sellers and Sellers shall fill such Purchase Orders (on a FIFO basis) from Sellers' stocks of Current Product existing as 42 of the Effective Date ("Stocks") or as necessary, Sellers shall manufacture and package, or have packaged, such Products. Each Purchase Order shall be in a form and contain terms previously agreed to by the parties. Each Purchase Order shall correspond to a total quantity of Product which is a whole number multiple of the applicable Batch Size as set forth in EXHIBIT D. The proposed delivery date recited in the Purchase Order shall also be equal to or greater than the applicable Lead Time for each such Product as set forth in EXHIBIT D. Each Purchase Order shall further specify the following: (i) the identity of Product by SKU, and (ii) the quantity of such Product.
(b) Sellers shall promptly acknowledge each Purchase Order by signing and returning to Buyers the acknowledgment copy of each Purchase Order promptly after its receipt. Failure of the Sellers to deliver to Buyers a written notice objecting to a Purchase Order within five (5) business days after receipt of the Purchase Order shall constitute Sellers' acceptance of the Purchase Order.
(c) In the event of any conflict between the terms and conditions of this Agreement and the terms and conditions of Buyer's Purchase Order, the terms and conditions of this Agreement shall be conducted:controlling.
4.4 Buyers may request Seller to accept an increase in Buyers' Annual Forecast of Product(s). Sellers' obligation with respect thereto shall solely be to exercise commercially reasonable efforts to accommodate Buyers' request so long as (Aa) on such increase represents a pull Manufacturing basis in respect whole number multiple of the Products as set out in clauses 3.2 and 3.4; or
(B) on a Toll Manufacturing Basis in respect of Products that are Tolled Products as set out in clause 5 (Toll Manufacture) and Exhibit 7 (Toll Manufacturing Provisions), and
(C) on the fifth (5th) Business Day Batch Size of each calendar month commencing not later than such Product, (b) the calendar month following period until the calendar month in which the Effective Date falls (or at such other dates as may be agreed between the Parties), the Purchaser shall provide to the Supplier a rolling demand forecast schedule (in such physical written format (as opposed to a data exchangeproposed date(s) exchangeable by email as of delivery is agreed by the Parties) which shall align with the applicable Gating Plan for that Gating Year and comprise a good faith estimate of its anticipated aggregate monthly requirements for Products for at least the following twenty-four (24) months or, in each case, such shorter period remaining under the Term (including any proposed extension thereof), in accordance with clause 3.2 ( the “Forecast Schedule”).
(A) Manufacturing and supply of Products under this Agreement shall be pursuant to the Forecast Schedules and to the Firm Orders submitted by the Purchaser, as further described in this clause 3.2.
(B) The initial Forecast Schedule is attached to this Agreement at Exhibit 14 (Initial Product Forecast Schedule) and the Parties agree that the Purchaser and the Supplier shall be bound by the volumes of Products shown in the Firm Zone of such initial Forecast Schedule as at the Effective Date. The initial Forecast Schedule shall reflect the migration of all orders that are in progress immediately prior to the Effective Date.
(C) Provided that the volumes of Products shown in the Firm Zone of each Forecast Schedule align with the requirements of the Gating Plan in respect of such Products, such volumes shall be deemed to be firm orders binding on the Purchaser and the Supplier, and the quantities included for each Product in any Firm Zone may not be varied in any subsequent Forecast Schedule unless the Supplier agrees in writing (each such firm order being a “Firm Order”). Each Firm Order shall be for not less than the Minimum Order Quantity of Product and, if greater than the Minimum Order Quantity, shall be for the Minimum Order Quantity plus one or more multiples of the Minimum Order Quantity. If the volumes specified in the Firm Order do not comply with this requirement then such variation to such volumes must be agreed between the Parties as part of the Firm Order confirmation process set out at 3.2(E).
(D) The Purchaser shall submit each Forecast Schedule either electronically or by such other means that the Manufacturing and Supply Team shall determine and to such location as reasonably requested by the Supplier in writing. No oral communications shall comprise a commitment to supply. Each Firm Order shall specify the volumes of Product required and the Purchaser’s requested Delivery date in accordance with the applicable Lead Time requirements as set out in Exhibit 1 for each such Product, (Products).
c) the proposed date(s) of delivery is within the Term, and (Ed) The Supplier shall respond to each Firm Order that complies with the requirements of this clause 3.2 proposed increase does not represent more than fifty percent (including the applicable Gating Plan):
(i50%) within two (2) Business Days of receipt (or such other date as agreed between the Parties) to acknowledge receipt of the Firm Order; and
(ii) within ten (10) Business Days Annual Forecast of receipt (or such other date as agreed between the Parties) to confirm the applicable order Delivery date and the volumes of Product required. In the event that the Supplier fails to respond to any Firm Order within ten (10) Business Days after acknowledging it, the Supplier shall be deemed to have acknowledged and accepted that Firm Order. Unless otherwise agreed by the Parties, the Supplier shall be obliged to acknowledge Firm Orders which comply with the requirements of this clause 3.2 without proposed amendments. The response (or deemed response) will include confirmation of the Delivery date. To the extent that the Supplier proposes an amendment to the Firm Order, the Purchaser shall respond to any proposed amendments to the Firm Order within ten (10) Business Days confirming whether it accepts or rejects such proposed amendments. If the Purchaser:
(iii) accepts such amendments, the Firm Order together with the relevant amendments shall be deemed to be acknowledged and accepted by the Supplier and shall be binding on both Parties; or
(iv) rejects such proposed amendments; the Parties will discuss the proposed amendments in good faith as promptly as practicable, but not more than five (5) Business Days following such rejection. The Parties agree that if the Parties cannot agree an amendment to the Firm Order pursuant to this clause 3.2(E) that the Firm Order initially submitted without the suggested amendments shall be binding on the Parties to the extent it is in accordance with this clause 3.2 and the applicable Gating Plan, provided that the Supplier may refer the matter for resolution in accordance with clauseProduct.
Appears in 1 contract
Forecasts and Orders. 3.1 Forecasting (a) ABBI agrees to provide Forecasts, Firm Forecasts and ordering of Product(s) under this Agreement shall be conducted:
(A) on a pull Manufacturing basis in respect of the Products as set out in clauses 3.2 and 3.4; or
(B) on a Toll Manufacturing Basis in respect of Products that are Tolled Products as set out in clause 5 (Toll Manufacture) and Exhibit 7 (Toll Manufacturing Provisions), and
(C) on the fifth (5th) Business Day of each calendar month commencing not later than the calendar month following the calendar month in which the Effective Date falls (or at such other dates as may be agreed between the Parties), the Purchaser shall provide to the Supplier a rolling demand forecast schedule (in such physical written format (as opposed to a data exchange) exchangeable by email as is agreed by the Parties) which shall align with the applicable Gating Plan for that Gating Year and comprise a good faith estimate of its anticipated aggregate monthly requirements Firm Orders for Products in whole batch increments for at least the following twenty-four each Product by National Drug Code (24"NDC") months or, in each case, such shorter period remaining under the Term (including any proposed extension thereof), in accordance with clause 3.2 ( the “Forecast Schedule”).
(A) Manufacturing and supply of procedures set forth in this Section 2.4. AZ shall use commercially reasonable efforts to deliver Products under this Agreement shall be pursuant to the Forecast Schedules and to ordered in accordance with timelines set forth in the Firm Orders submitted by the Purchaser, as further described ABBI in accordance with this clause 3.2Section 2.4.
(Bb) The ABBI shall submit an initial Forecast Schedule is attached to firm order ("Initial Firm Order") upon execution of this Agreement at Exhibit 14 (Initial Product Forecast Schedule) for the entire inventory of the Products in final form and the Parties agree that the Purchaser and the Supplier shall be bound by the volumes of Products shown labeled for sale in the Firm Zone Territory then held by AZ anywhere in the world on and as of such initial Forecast Schedule as at the Effective Datedate. The initial Forecast Schedule shall reflect the migration of all orders that are in progress immediately prior to the Effective Date.
(C) Provided that the volumes of Products shown in the Firm Zone of each Forecast Schedule align with the requirements of the Gating Plan in respect of such Products, such volumes shall be deemed to be firm orders binding on the Purchaser and the Supplier, and the quantities included for each Product in any Firm Zone may not be varied in any subsequent Forecast Schedule unless the Supplier agrees in writing (each such firm order being a “Firm Order”). Each Initial Firm Order shall be for not less than specify a delivery date that is not [***] from the Minimum Order Quantity date of Product andthis Agreement. AZ and ABBI agree that, if greater than the Minimum Order Quantity, shall be for the Minimum Order Quantity plus one or more multiples of the Minimum Order Quantity. If the volumes specified in the Firm Order do not comply with this requirement then such variation to such volumes must be agreed between the Parties as part of the Initial Firm Order, AZ shall supply to ABBI, not less than a [***], based on the [***] and that, notwithstanding the preceding sentence, such amount of [***] will be delivered on the delivery date specified in the Initial Firm Order confirmation process set out at 3.2(Eor as soon thereafter as is commercially reasonable. The cost of that part of the Initial Firm Order that consists of [***] is included in the Purchase Price (as defined in the Asset Purchase Agreement), and ABBI shall only be obligated to pay for the other Products included in the Initial Firm Order in accordance with Section 5 of this Agreement.
(Dc) The Purchaser shall submit each Forecast Schedule either electronically Within two business days following the Effective Date, or by such other means that the Manufacturing and Supply Team shall determine and to such location as reasonably requested by the Supplier in writing. No oral communications shall comprise a commitment to supply. Each Firm Order shall specify the volumes of Product required and the Purchaser’s requested Delivery date in accordance with the applicable Lead Time requirements as set out in Exhibit 1 (Products).
(E) The Supplier shall respond to each Firm Order that complies with the requirements of this clause 3.2 (including the applicable Gating Plan):
(i) within two (2) Business Days of receipt (or on such other date as may be agreed between to by the Parties) Parties in writing, ABBI shall provide to acknowledge receipt AZ a non-binding forecast of ABBI �s requirements for each Product by NDC for a [***] (a "Forecast"). Such Forecast shall be revised quarterly for a rolling [***] period and delivered to AZ on the first day of each calendar quarter. In addition, for the purposes of AZ's long-term planning, ABBI shall provide a non-binding best estimate of a [***] forecast of its anticipated quarterly requirements for each Product by NDC, which shall be updated on an annual basis on the anniversary of the Firm Order; andEffective Date of this Agreement.
(iid) within Within ten (10) Business Days business days after the Effective Date of receipt this Agreement, ABBI shall submit to AZ a non-cancelable purchase order (a "Firm Order") for ABBI's orders of Products by NDC to be delivered during the remainder of the current calendar quarter and the following first full calendar quarter. Thereafter, ABBI shall submit a Firm Order no later than the first day of each calendar quarter for all of ABBI's orders of Products by NDC to be delivered in the following calendar quarter. ABBI shall also submit to AZ along with such Firm Order a forecast for the next calendar quarter following the quarter to which the Firm Order applies (a "Firm Forecast"). (See Schedule E attached hereto.) The volume set forth in any Firm Order may not deviate more than [***] for each Product by NDC from the Firm Forecast submitted to AZ by ABBI for such calendar quarter.
(e) AZ will respond within [***] of receiving each of ABBI's quarterly rolling Forecast, Firm Forecast and Firm Order, and will either (i) confirm acceptance by AZ of the Forecast, Firm Forecast and Firm Order quantities or such other date as agreed (ii) reject the requested quantities and initiate dialogue between the Parties to arrive at mutually acceptable values for the Forecast, Firm Forecast and Firm Order. AZ will use commercially reasonable efforts to accommodate any additional quantity of Products requested by ABBI after the Firm Order has been submitted to AZ, but AZ shall not be liable in any respect for its inability to do so. Notwithstanding anything in this Agreement to the contrary, AZ shall have no obligation to supply more than [***] of the aggregate volume of each Product by NDC for such calendar quarter set forth in any Firm Forecast. Firm Orders may be amended only by mutual agreement of the Parties) to confirm the applicable order Delivery date and the volumes of Product required, in writing. In Furthermore, in the event that the Supplier fails to respond to any ABBI submits a Firm Order within ten (10for a volume that is less than [***] of the volume of any Product(s) Business Days after acknowledging itby NDC indicated in the Firm Forecast for such calendar quarter, the Supplier shall be deemed and AZ elects to have acknowledged and accepted that accept such Firm Order. Unless otherwise agreed by the Parties, the Supplier then AZ shall be obliged use commercially reasonable efforts to acknowledge Firm Orders which comply with utilize excess Components, Materials and Work in Process as a result of such order shortfall for the requirements of other Affiliates of AZ or for future periods covered by this clause 3.2 without proposed amendments. The response (or deemed response) will include confirmation of the Delivery date. To the extent that the Supplier proposes an amendment to the Firm Order, the Purchaser shall respond to any proposed amendments to the Firm Order within ten (10) Business Days confirming whether it accepts or rejects such proposed amendmentsAgreement. If AZ is unable to utilize such Components, Materials and Work in Process, then in such case (and only in such case) AZ shall have the Purchaser:
(iii) accepts right to invoice ABBI for the cost of all Components, Materials and Work in Progress that AZ discarded as a result of such amendments, the Firm Order together with the relevant amendments shall be deemed to be acknowledged and accepted by the Supplier and shall be binding on both Parties; or
(iv) rejects such proposed amendments; the Parties will discuss the proposed amendments in good faith as promptly as practicable, but not more than five (5) Business Days following such rejection. The Parties agree that if the Parties cannot agree an amendment to the Firm Order pursuant to this clause 3.2(E) that the Firm Order initially submitted without the suggested amendments shall be binding on the Parties to the extent it is in accordance with this clause 3.2 and the applicable Gating Plan, provided that the Supplier may refer the matter for resolution in accordance with clauseorder shortfall.
Appears in 1 contract
Samples: Manufacturing Agreement
Forecasts and Orders. 3.1 Forecasting and ordering of Product(s) under this Agreement shall be conducted:
(A) on a pull Manufacturing basis in respect of the Products as set out in clauses 3.2 and 3.4; or
(B) on a Toll Manufacturing Basis in respect of Products that are Tolled Products as set out in clause 5 (Toll Manufacture) and Exhibit 7 (Toll Manufacturing Provisions), and
(C) on the fifth (5th) Business Day of each calendar month commencing not By no later than [***] each year during the calendar month following the calendar month in which the Effective Date falls (or at such other dates as may Term, Buyer undertakes to provide Seller with an annual non-binding forecast taking into account any seasonality effect that would reasonably be agreed between the Parties)expected to impact Buyer’s business, the Purchaser shall provide to regularity of Buyer’s production pace and the Supplier a rolling demand forecast schedule (in such physical written format (as opposed to a data exchange) exchangeable by email as is agreed by the Parties) which shall align with the applicable Gating Plan for that Gating Year and comprise a good faith estimate regularity of its anticipated aggregate monthly requirements for Products for at least the following twenty-four (24) months or, in each case, such shorter period remaining under the Term (including any proposed extension thereof), in accordance with clause 3.2 ( the “Forecast Schedule”).
(A) Manufacturing and supply of Products under this Agreement shall be pursuant to the Forecast Schedules and to the Firm Orders submitted by the Purchaser, as further described in this clause 3.2.
(B) The initial Forecast Schedule is attached to this Agreement at Exhibit 14 (Initial Product Forecast Schedule) and the Parties agree over a calendar year; provided that the Purchaser and the Supplier shall be bound by the volumes of Products shown in the Firm Zone of such initial Forecast Schedule as at the Effective Date. The initial Forecast Schedule shall reflect the migration of all orders that are in progress immediately prior to the Effective Date.
(C) Provided that the volumes of Products shown in the Firm Zone of each Forecast Schedule align with the requirements of the Gating Plan in respect of such Products, such volumes shall be deemed to be firm orders binding on the Purchaser and the Supplier, and the quantities included for each Product in any Firm Zone may not be varied in any subsequent Forecast Schedule unless the Supplier agrees in writing (each such firm order being a “Firm Order”). Each Firm Order shall be for not less than the Minimum Order Quantity of Product and, if greater than the Minimum Order Quantity, shall be for the Minimum Order Quantity plus one or more multiples of the Minimum Order Quantity. If the volumes specified in the Firm Order do not comply with this requirement then such variation to such volumes must be agreed between the Parties as part of the Firm Order confirmation process set out at 3.2(E).
(D) The Purchaser shall submit each Forecast Schedule either electronically or by such other means that the Manufacturing and Supply Team shall determine and to such location as reasonably requested by the Supplier in writing. No oral communications shall comprise a commitment to supply. Each Firm Order shall specify the volumes of Product required and the Purchaser’s requested Delivery date in accordance with the applicable Lead Time requirements as set out in Exhibit 1 (Products).
(E) The Supplier shall respond to each Firm Order that complies with the requirements of this clause 3.2 (including the applicable Gating Plan):
(i) within two (2) Business Days of receipt (or with respect to 2020, Buyer undertakes to provide Seller with an annual non-binding forecast for such other date as agreed between the Parties) to acknowledge receipt of the Firm Order; and
calendar year no later than [***] and (ii) with respect to the quantities of Product Ordered by Buyer to be Delivered in [***], Buyer shall inform Seller of such quantities and their quarterly allocation over the year by no later than [***] each year. With regard to 2020, Buyer shall inform Seller of the quantities to be Delivered in [***] before [***]. In addition to the annual non-binding forecast, Buyer undertakes to provide Seller with a [***] binding rolling forecast at least thirty (30) days before the starting date of the [***] rolling forecast, detailing Product, quantities, packaging and delivery points; provided that with respect to 2020, Buyer undertakes to provide Seller with a binding forecast for the balance of Q1 2020 no later than [***]. In any event, Seller shall confirm in writing its acceptance of Buyer’s [***] binding rolling forecast within ten (10) Business Days from the date of receipt (or such other date as agreed between the Parties) to confirm the applicable order Delivery date and the volumes of Product requiredby Seller. In the event that the Supplier fails to respond to any Firm Order Buyer does not receive such written acceptance within ten such 10 (10ten) Business Days after acknowledging it, the Supplier shall be deemed to have acknowledged Day period and accepted that Firm Order. Unless otherwise agreed by the Parties, the Supplier shall be obliged to acknowledge Firm Orders which comply with the requirements of this clause 3.2 without proposed amendments. The response (or deemed response) will include confirmation of the Delivery date. To the extent that the Supplier proposes an amendment to the Firm Order, the Purchaser shall respond to any proposed amendments to the Firm Order within ten (10) Business Days confirming whether it accepts or rejects such proposed amendments. If the Purchaser:
(iii) accepts such amendments, the Firm Order together with the relevant amendments forecast shall be deemed to be acknowledged and accepted by Seller. In case Buyer fails to provide Seller with its [***] binding rolling forecast, Buyer shall purchase the Supplier and shall be quantities set forth in the annual non-binding forecast, that then become binding on both Parties; or
(iv) rejects Buyer on a rolling [***] basis, until such proposed amendments; the Parties will discuss the proposed amendments in good faith time as promptly as practicable, but not more than five (5) Business Days following Buyer provides such rejection. The Parties agree that if the Parties cannot agree an amendment to the Firm Order pursuant to this clause 3.2(E) that the Firm Order initially submitted without the suggested amendments shall be binding on the Parties to the extent it is in accordance with this clause 3.2 rolling forecast and the applicable Gating Plan, provided that the Supplier may refer the matter for resolution in accordance with clauseSeller confirms its acceptance of it.
Appears in 1 contract
Forecasts and Orders. 3.1 Forecasting and ordering of Product(s4.1 Beginning no later than six (6) under this Agreement shall Months prior to placing its initial Purchase Order for Product (it being understood that a forecast for a Calendar Quarter may be conducted:
(A) on a pull Manufacturing basis in respect of the Products as set out in clauses 3.2 and 3.4; or
(B) on a Toll Manufacturing Basis in respect of Products that are Tolled Products as set out in clause 5 (Toll Manufacture) and Exhibit 7 (Toll Manufacturing Provisionszero), and
(C) on prior to the fifth (5th) Business Day first day of each calendar month commencing not later than the calendar month following the calendar month in which the Effective Date falls quarter (or at such other dates beginning each 1st January, 1st April, 1st July and 1st October and each referred to herein as may be agreed between the Partiesa “Calendar Quarter”), the Purchaser CLEARSIDE BIOMEDICAL shall provide to the Supplier GERRESHEIMER with a rolling demand forecast schedule (in such physical written format (as opposed to a data exchange) exchangeable by email as is agreed by the Parties) which shall align with the applicable Gating Plan for that Gating Year and comprise a good faith estimate of its anticipated aggregate monthly requirements projected orders for the Products for at least the following twenty-four (244) months or, in each case, such shorter period remaining under the Term Calendar Quarters (including any proposed extension thereof), in accordance with clause 3.2 ( the “Forecast Schedule”). The initial forecast will be provided by July 1, 2018 and is expected to reflect projected orders of between [***] units of Product for the following (4) Calendar Quarters. Beginning with the first Forecast Schedule submitted after the one year anniversary of the first commercial sale of the Product to a Third Party (the “Commercial Launch Anniversary”), with CLEARSIDE BIOMEDICAL to notify GERRESHEIMER forthwith in writing of the date of the Commercial Launch. Subject to Clause 4.4, CLEARSIDE BIOMEDICAL can only vary the forecast amounts for the second Calendar Quarter of a Forecast Schedule in the next subsequent Forecast Schedule by +/- [***], and can only vary the forecast amounts for the third Calendar Quarter of a Forecast Schedule in the next subsequent Forecast Schedule by +/- [***]. If CLEARSIDE BIOMEDICAL desires to vary the forecasted amounts by an additional [***] up to [***] or up to [***] respectively, then (i) in case of an increase, GERRESHEIMER agrees to notify Buyer within five (5) Business Days after receipt of such request, whether the ordered additional quantities of Products set forth in the request are exceeding the Sprint Capacity and whether such exceeding quantities can be delivered or not. In any event GERRESHEIMER will use reasonable efforts to fulfill this additional demand. In the event such excess quantities of Product directly results in additional costs, such costs shall be documented by GERRESHEIMER and the Parties shall discuss in good faith such costs and what part thereof CLEARSIDE BIOMEDICAL may need to reimburse before any such costs are incurred and/or committed. If GERRESHEIMER, despite using reasonable efforts, cannot meet such excess quantities, the failure to supply the excess quantities shall not be regarded as a Failure to Supply; or (ii) in case of a decrease, if such decrease directly results in additional costs, such costs shall be documented by GERRESHEIMER and the CLEARSIDE BIOMEDICAL shall reimburse to GERRESHEIMER all such documented costs. For the avoidance of doubt, the maximum quantities of Products to be supplied by GERRESHEIMER during any six (6) Month period prior to the Commercial CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Launch Anniversary shall be [***] units of Product and GERRESHEIMER shall be under no obligation whatsoever to supply any quantities of Product beyond that amount.
(A) Manufacturing and supply of Products under this Agreement shall be pursuant 4.2 In addition to the Forecast Schedules and to the Firm Orders submitted by the PurchaserSchedule, as further described in this clause 3.2.
(B) The initial Forecast Schedule is attached to this Agreement at Exhibit 14 (Initial Product Forecast Schedule) and the Parties agree that the Purchaser and the Supplier shall be bound by the volumes of Products shown in the Firm Zone of such initial Forecast Schedule as at the Effective Date. The initial Forecast Schedule shall reflect the migration of all orders that are in progress immediately prior to the Effective Date1st September of each Year after the commencement of the issuance of Forecast Schedules, CLEARSIDE BIOMEDICAL shall provide on an annual basis a two (2) Year non-binding forecast of projected orders for the Products to be used by GERRESHEIMER solely for planning purposes.
(C) Provided that the volumes of 4.3 The Products shown detailed in the Firm Zone first Calendar Quarter of each Forecast Schedule align with (“Firm Order”) will be binding on both Parties. CLEARSIDE BIOMEDICAL shall issue purchase orders against each Firm Order (each a “Purchase Order”), which Purchase Order shall include the requirements requested delivery dates. GERRESHEIMER shall respond to each Purchase Order received from CLEARSIDE BIOMEDICAL within ten (10) Business Days of receipt. The response of GERRESHEIMER shall include confirmation of the Gating Plan delivery dates; PROVIDED, HOWEVER, that GERRESHEIMER may not reject any quantities forecasted in respect a Firm Order or any delivery date that is more than thirty (30) days from the date the applicable Purchase Order is submitted. GERRESHEIMER’s failure to reject any portion of such Products, such volumes a Purchase Order within the applicable ten (10) Business Day period shall be deemed to be firm orders binding on GERRESHEIMER’s acceptance thereof. In the Purchaser and the Supplier, and event that either Party requires amendments to the quantities included for each Product in any Firm Zone may not be varied in any subsequent Forecast Schedule unless ordered, the Supplier agrees in writing (each such firm order being a “Firm Order”). Each Firm Order timing of production and/or delivery, the relevant planning personnel from both Parties shall be for not less than the Minimum Order Quantity of Product and, if greater than the Minimum Order Quantity, shall be for the Minimum Order Quantity plus one or more multiples of the Minimum Order Quantity. If the volumes specified in the Firm Order do not comply with this requirement then such variation to such volumes must be agreed between the Parties as part of the Firm Order confirmation process set out at 3.2(E).
(D) The Purchaser shall submit each Forecast Schedule either electronically or by such other means that the Manufacturing and Supply Team shall determine and to such location as reasonably requested by the Supplier in writing. No oral communications shall comprise a commitment to supply. Each Firm Order shall specify the volumes of Product required and the Purchaser’s requested Delivery date in accordance with the applicable Lead Time requirements as set out in Exhibit 1 (Products).
(E) The Supplier shall respond to each Firm Order that complies with the requirements of this clause 3.2 (including the applicable Gating Plan):
(i) within two (2) Business Days of receipt (or such other date as agreed between the Parties) to acknowledge receipt of the Firm Order; and
(ii) within ten (10) Business Days of receipt (of a Forecast Schedule, Firm Order or such other date Purchase Order discuss in good faith and agree amendments to the Forecast Schedule, Firm Order or Purchase Order.
4.4 CLEARSIDE BIOMEDICAL and/or its Affiliates shall use commercially reasonable endeavours not to, at any one time, collectively place Firm Orders at a level that would require an aggregate capacity at GERRESHEIMER greater than the maximum manufacturing capacity of the Manufacturing Site as agreed between the Parties) to confirm set forth in the applicable order Delivery date Product Schedule (“Sprint Capacity”) and GERRESHEIMER shall not be obliged to supply Products in excess of the volumes of Product requiredSprint Capacity. In the event that the Supplier fails aggregate CLEARSIDE BIOMEDICAL demand is greater than the Sprint Capacity CLEARSIDE BIOMEDICAL shall promptly instruct GERRESHEIMER the order of preference for the deliveries.
4.5 It is understood that the remaining three (3) Calendar Quarters of the Forecast Schedule constitutes an estimate of the future Product requirement of CLEARSIDE BIOMEDICAL and its Affiliates and does not constitute a binding commitment by CLEARSIDE BIOMEDICAL or its Affiliates to order or purchase such Product.
4.6 For certain long lead time materials, as defined in good faith between the Parties, which requires GERRESHEIMER to place orders with a minimum lead time longer than three (3) Months in advance of manufacturing, GERRESHEIMER will be entitled to place those orders based on the projections set forth in a Forecast CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Schedule, and CLEARSIDE BIOMEDICAL agrees to pay for any such Materials which are not used in Firm Orders of Products placed by CLEARSIDE BIOMEDICAL and/or its Affiliates and cannot otherwise be used by GERRESHEIMER.
4.7 CLEARSIDE BIOMEDICAL may from time to time provide GERRESHEIMER with individual purchase orders for Products in addition to the quantities set forth in Firm Orders. GERRESHEIMER shall respond to any Firm Order each such individual purchase order received from CLEARSIDE BIOMEDICAL or an Affiliate of CLEARSIDE BIOMEDICAL within ten (10) Business Days after acknowledging it, of receipt. The response shall include confirmation or not of the Supplier Delivery dates and quantity as set out in such individual purchase order. GERRESHEIMER’s failure to reject any portion of such Purchase Order within the applicable ten (10) Business Day period shall be deemed to have acknowledged be GERRESHEIMER’s acceptance thereof.
4.8 If a CLEARSIDE BIOMEDICAL Affiliate desires to purchase the Product from GERRESHEIMER under the terms of this Agreement the Parties will consider the appropriate contractual mechanisms for the CLEARSIDE BIOMEDICAL Affiliate to receive Product from GERRESHEIMER or its Affiliates (as the case may be) and accepted that Firm Orderbenefit from the terms of this Agreement, taking into account the CLEARSIDE BIOMEDICAL Affiliate may need to enter into separate legal agreements with GERRESHEIMER. Unless otherwise For the avoidance of doubt, before the aforementioned contractual mechanism has been agreed by the Parties, the Supplier GERRESHEIMER shall not be obliged to acknowledge Firm Orders which comply sell (and/or deliver) any Products to CLEARSIDE BIOMEDICAL Affiliates or fulfil or accept purchase orders from CLEARSIDE BIOMEDICAL Affiliates. GERRESHEIMER shall confirm promptly to CLEARSIDE BIOMEDICAL whether such CLEARSIDE BIOMEDICAL Affiliate is covered by GERRESHEIMER’s trade credit insurance. If such COMPANY Affiliate is not covered by GERRESHEIMERs trade credit insurance, then GERRESHEIMER shall only provide such CLEARSIDE BIOMEDICAL Affiliate with the requirements named Product upon receipt of this clause 3.2 without proposed amendments. The response (a payment security from CLEARSIDE BIOMEDICAL by means of a payment guarantee of CLEARSIDE BIOMEDICAL or deemed response) will include confirmation a bank guarantee of the Delivery date. To the extent that the Supplier proposes an amendment to the Firm Order, the Purchaser shall respond to any proposed amendments to the Firm Order within ten (10) Business Days confirming whether it accepts or rejects such proposed amendments. If the Purchaser:
(iii) accepts such amendments, the Firm Order together internationally business bank rated with the relevant amendments shall be deemed to be acknowledged and accepted by the Supplier and shall be binding on both Parties; or
(iv) rejects such proposed amendments; the Parties will discuss the proposed amendments in good faith as promptly as practicable, but not more than five (5) Business Days following such rejection. The Parties agree that if the Parties cannot agree an amendment to the Firm Order pursuant to this clause 3.2(E) that the Firm Order initially submitted without the suggested amendments shall be binding on the Parties to the extent it is in accordance with this clause 3.2 and the applicable Gating Plan, provided that the Supplier may refer the matter for resolution in accordance with clausetriple B.
Appears in 1 contract
Forecasts and Orders. 3.1 Forecasting and ordering of Product(s(a) under this Agreement shall be conducted:
Every ninety (A90) on a pull Manufacturing basis in respect of days during the Products as set out in clauses 3.2 and 3.4; or
(B) on a Toll Manufacturing Basis in respect of Products that are Tolled Products as set out in clause 5 (Toll Manufacture) and Exhibit 7 (Toll Manufacturing Provisions)Term, and
(C) on the fifth (5th) Business Day of each calendar month commencing not later than the calendar month following the calendar month in which the Effective Date falls (or at such other dates as may be agreed between the Parties), the Purchaser Can-Am shall provide to the Supplier a rolling demand forecast schedule AMG with (in such physical written format (as opposed to a data exchangei) exchangeable by email as is agreed by the Parties) which shall align with the applicable Gating Plan for that Gating Year and comprise a good faith estimate forecast (a "Forecast") of its anticipated aggregate monthly requirements for Products for at least purchases of M/C Lancets during each of the following twenty-four (244) months or, in each case, such shorter period remaining under three-month periods ("Quarters") following the Term date of the forecast (including any proposed extension thereofthe "Forecast Date"), in accordance with clause 3.2 ( the “Forecast Schedule”).
and (Aii) Manufacturing and supply of Products under this Agreement shall be pursuant to the Forecast Schedules and to the Firm Orders submitted by the Purchaser, as further described in this clause 3.2.
a binding purchase order (B"Purchase Order") The initial Forecast Schedule is attached to this Agreement at Exhibit 14 (Initial Product Forecast Schedule) and the Parties agree that the Purchaser and the Supplier shall be bound by the volumes of Products shown in the Firm Zone of such initial Forecast Schedule as at the Effective Date. The initial Forecast Schedule shall reflect the migration of all orders that are in progress immediately prior to the Effective Date.
(C) Provided that the volumes of Products shown in the Firm Zone of each Forecast Schedule align with the requirements of the Gating Plan in respect of such Products, such volumes shall be deemed for M/C Lancets to be firm orders binding on the Purchaser and the Supplier, and the quantities included for each Product in any Firm Zone may not be varied in any subsequent Forecast Schedule unless the Supplier agrees in writing (each such firm order being a “Firm Order”). Each Firm Order shall be for not less than the Minimum Order Quantity of Product and, if greater than the Minimum Order Quantity, shall be for the Minimum Order Quantity plus one or more multiples of the Minimum Order Quantity. If the volumes specified in the Firm Order do not comply with this requirement then such variation shipped from time to such volumes must be agreed between the Parties as part of the Firm Order confirmation process set out at 3.2(E).
(D) The Purchaser shall submit each Forecast Schedule either electronically or by such other means that the Manufacturing and Supply Team shall determine and to such location as reasonably requested by the Supplier in writing. No oral communications shall comprise a commitment to supply. Each Firm Order shall specify the volumes of Product required and the Purchaser’s requested Delivery date time in accordance with the applicable Lead Time requirements as set out in Exhibit 1 provisions of this Agreement. Can-Am agrees to purchase from AMG (Products)A) no less than 100% of the M/C Lancets that it forecasted that it would purchase during the first two Quarters of its most recent Forecast, and (B) no less than 85% of the M/C Lancets that it forecasted that it would purchase during the third and fourth Quarters of its most recent Forecast.
(Eb) The Supplier Can-Am shall respond authorize shipment of M/C Lancets by issuing a Purchase Order to each Firm Order that complies AMG, and AMG shall cause M/C Lancets to be shipped in accordance with the requirements Purchase Order. Each Purchase Order shall be in the form of this clause 3.2 (including the applicable Gating Plan):
Exhibit A hereto. Each Purchase Order shall identify (i) within two the quantity and other characteristics (2including pack size, packaging information, gauge, SKU and color) Business Days of receipt (or such other date as agreed between the Parties) M/C Lancets to acknowledge receipt of the Firm Order; and
be delivered and (ii) within the required delivery date, which date shall not be less than ten (10) Business Days days after the date of receipt the relevant Purchase Order.
(or such other date as agreed between c) AMG shall promptly acknowledge each Purchase Order by signing and returning to Can-Am the Parties) to confirm the applicable order Delivery date and the volumes acknowledgment copy of Product requiredeach Purchase Order promptly after its receipt. In the event that the Supplier fails to respond to any Firm Order within ten (10) Business Days after acknowledging it, the Supplier AMG shall be deemed to have acknowledged and accepted that Firm Order. Unless otherwise agreed by the Parties, the Supplier shall be obliged a Purchase Order unless it delivers to acknowledge Firm Orders which comply with the requirements of this clause 3.2 without proposed amendments. The response (or deemed response) will include confirmation of the Delivery date. To the extent that the Supplier proposes an amendment Can-Am a written notice objecting to the Firm Order, the Purchaser shall respond to any proposed amendments to the Firm such Purchase Order within ten (10) Business Days confirming whether it accepts or rejects such proposed amendments. If the Purchaser:
(iii) accepts such amendments, the Firm Order together with the relevant amendments shall be deemed to be acknowledged and accepted by the Supplier and shall be binding on both Parties; or
(iv) rejects such proposed amendments; the Parties will discuss the proposed amendments in good faith as promptly as practicable, but not more than five (5) Business Days following business days after receipt of such rejection. The Parties agree that if Purchase Order.
(d) In the Parties cannot agree an amendment to event of any conflict between the Firm terms and conditions of this Agreement and the terms and conditions of Can-Am's Purchase Order pursuant to or any other document, the terms and conditions of this clause 3.2(E) that the Firm Order initially submitted without the suggested amendments Agreement shall be binding on controlling.
(e) The parties hereto may agree to modify the Parties to the extent it is in accordance with this clause 3.2 procedures for ordering and the applicable Gating Plan, provided that the Supplier may refer the matter for resolution in accordance with clausedelivering M/C Lancets hereunder.
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Samples: Supply Agreement (Selfcare Inc)
Forecasts and Orders. 3.1 Forecasting (a) Buyers have provided Sellers with a non-binding forecast of its purchases of Products for the Term within the Territory, said forecast being attached hereto as EXHIBIT B.
(b) Within ten (10) business days of the Effective Date, Buyers shall update the forecast described in Paragraph 4.1
(a) Such amended forecast shall be a non-binding (except as provided in Paragraph 14.1(c)) forecast of its purchases of Products for the term with the Territory ("Annual Forecast"). Each Product is to be identified in such Annual Forecast by individual SKU.
(a) Every thirty (30) days during the term hereof, Buyers shall provide Sellers with a good faith, non-binding forecast of its purchases of Products during the next three (3) month period. Such forecasts shall be made recognizing the requirements for Batch Sizes and ordering Lead Times as defined in Paragraph 4.3(b) hereof.
(b) Sellers have presented Buyers with, and Buyers acknowledge the receipt of, a document listing the Products, the batch size used in the production of Product(seach such Product ("Batch Size"), and the lead times required to manufacture each of said Products ("Lead Times"), such document being appended hereto as EXHIBIT D.
(a) under Buyers shall authorize the manufacture and packaging of a Product by issuing a purchase order ("Purchase Order") to Sellers and Sellers shall manufacture and package, or have packaged, such Products. Each Purchase Order shall be in a form and contain terms previously agreed to by the parties. Each Xxxxxxxx Xxxer shall correspond to a total quantity of Product which is a whole number multiple of the applicable Batch Size as set forth in EXHIBIT D. The proposed delivery date recited in the Purchase Order shall also be equal to or greater than the applicable Lead Time for each such Product as set forth in EXHIBIT D. Each Purchase Order shall further specify the following: (i) the identity of Product by SKU, and (ii) the quantity of such Product.
(b) Sellers shall promptly acknowledge each Purchase Order by signing and returning to Buyers the acknowledgment copy of each Purchase Order promptly after its receipt. Failure of the Sellers to deliver to Buyers a written notice objecting to a Purchase Order within five (5) business days after receipt of the Purchase Order shall constitute Sellers' acceptance of the Purchase Order.
(c) In the event of any conflict between the terms and conditions of this Agreement and the terms and conditions of Buyers' Purchase Order or any other document, the terms and conditions of this Agreement shall be conducted:controlling.
4.4 Buyers may request Sellers to accept an increase in Buyers' Annual Forecast of Product(s). Sellers' obligation with respect thereto shall solely be to exercise commercially reasonable efforts to accommodate Buyers' request so long as (Aa) on such increase represents a pull Manufacturing basis in respect whole number multiple of the Products as set out in clauses 3.2 and 3.4; or
(B) on a Toll Manufacturing Basis in respect of Products that are Tolled Products as set out in clause 5 (Toll Manufacture) and Exhibit 7 (Toll Manufacturing Provisions), and
(C) on the fifth (5th) Business Day Batch Size of each calendar month commencing not later than such Product, (b) the calendar month following period until the calendar month in which the Effective Date falls (or at such other dates as may be agreed between the Parties), the Purchaser shall provide to the Supplier a rolling demand forecast schedule (in such physical written format (as opposed to a data exchangeproposed date(s) exchangeable by email as of delivery is agreed by the Parties) which shall align with the applicable Gating Plan for that Gating Year and comprise a good faith estimate of its anticipated aggregate monthly requirements for Products for at least the following twenty-four (24) months or, in each case, such shorter period remaining under the Term (including any proposed extension thereof), in accordance with clause 3.2 ( the “Forecast Schedule”).
(A) Manufacturing and supply of Products under this Agreement shall be pursuant to the Forecast Schedules and to the Firm Orders submitted by the Purchaser, as further described in this clause 3.2.
(B) The initial Forecast Schedule is attached to this Agreement at Exhibit 14 (Initial Product Forecast Schedule) and the Parties agree that the Purchaser and the Supplier shall be bound by the volumes of Products shown in the Firm Zone of such initial Forecast Schedule as at the Effective Date. The initial Forecast Schedule shall reflect the migration of all orders that are in progress immediately prior to the Effective Date.
(C) Provided that the volumes of Products shown in the Firm Zone of each Forecast Schedule align with the requirements of the Gating Plan in respect of such Products, such volumes shall be deemed to be firm orders binding on the Purchaser and the Supplier, and the quantities included for each Product in any Firm Zone may not be varied in any subsequent Forecast Schedule unless the Supplier agrees in writing (each such firm order being a “Firm Order”). Each Firm Order shall be for not less than the Minimum Order Quantity of Product and, if greater than the Minimum Order Quantity, shall be for the Minimum Order Quantity plus one or more multiples of the Minimum Order Quantity. If the volumes specified in the Firm Order do not comply with this requirement then such variation to such volumes must be agreed between the Parties as part of the Firm Order confirmation process set out at 3.2(E).
(D) The Purchaser shall submit each Forecast Schedule either electronically or by such other means that the Manufacturing and Supply Team shall determine and to such location as reasonably requested by the Supplier in writing. No oral communications shall comprise a commitment to supply. Each Firm Order shall specify the volumes of Product required and the Purchaser’s requested Delivery date in accordance with the applicable Lead Time requirements as set out in Exhibit 1 for each such Product, (Products).
c) the proposed date(s) of delivery is within the Term, and (Ed) The Supplier shall respond to each Firm Order that complies with the requirements of this clause 3.2 proposed increase does not represent more than fifty percent (including the applicable Gating Plan):
(i50%) within two (2) Business Days of receipt (or such other date as agreed between the Parties) to acknowledge receipt of the Firm Order; and
(ii) within ten (10) Business Days Annual Forecast of receipt (or such other date as agreed between the Parties) to confirm the applicable order Delivery date and the volumes of Product required. In the event that the Supplier fails to respond to any Firm Order within ten (10) Business Days after acknowledging it, the Supplier shall be deemed to have acknowledged and accepted that Firm Order. Unless otherwise agreed by the Parties, the Supplier shall be obliged to acknowledge Firm Orders which comply with the requirements of this clause 3.2 without proposed amendments. The response (or deemed response) will include confirmation of the Delivery date. To the extent that the Supplier proposes an amendment to the Firm Order, the Purchaser shall respond to any proposed amendments to the Firm Order within ten (10) Business Days confirming whether it accepts or rejects such proposed amendments. If the Purchaser:
(iii) accepts such amendments, the Firm Order together with the relevant amendments shall be deemed to be acknowledged and accepted by the Supplier and shall be binding on both Parties; or
(iv) rejects such proposed amendments; the Parties will discuss the proposed amendments in good faith as promptly as practicable, but not more than five (5) Business Days following such rejection. The Parties agree that if the Parties cannot agree an amendment to the Firm Order pursuant to this clause 3.2(E) that the Firm Order initially submitted without the suggested amendments shall be binding on the Parties to the extent it is in accordance with this clause 3.2 and the applicable Gating Plan, provided that the Supplier may refer the matter for resolution in accordance with clauseProduct.
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