Forecasts and Orders. 5.1 During the term of this Agreement, Baxter will submit to Oravax, the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trials. The first Baxter Requirements Schedule shall be submitted to Oravax twelve (12) calendar months before Baxter anticipates requiring the Manufacture of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than the tenth (10th) day of each calendar month, specifying B▇▇▇▇▇’▇ anticipated requirements for each Product in calendar monthly periods for the relevant twelve (12) month period covered by Baxter Requirements Schedule. 5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering the Firm Period of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated as being required in the last month of the Firm Period. 5.3 Other than during the first four (4) months of the first Baxter Requirements Schedule for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product as soon as is reasonably practicable to Baxter (“Delivery Date”). Oravax shall deliver such Product no later than fourteen (14) days after the Delivery Date. 5.4 No purchase order shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule. 5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments. 5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordingly. In the event that any raw materials have a lead time of longer duration than the Firm Period, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order to the extent necessary to coincide with the said lead times. 5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder. 5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90) days after the stipulated delivery date shall be the only reasons for which B▇▇▇▇▇ may reject the Products. If B▇▇▇▇▇ wishes to reject any delivery of Product it must notify Oravax within thirty (30) days of receipt of the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ shall be deemed to have accepted the Product and shall not be entitled to reject the same unless it provides such written notification within the said period of thirty (30) days. Oravax shall notify B▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection whether it accepts B▇▇▇▇▇’▇ claim. If Oravax does not accept that it has failed to Manufacture the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator and the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches in question and by Oravax from any samples that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to discuss in good faith the failure of the Batch in question and the resolution of the dispute between them. 5.9 If a Product does not conform to the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32. 5.10 If, in any calendar year of this Agreement beginning 2005, the Manufacturing Fees received by Oravax are less than the sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such notice.
Appears in 1 contract
Forecasts and Orders. 5.1 During the term 3.1 Forecasting and ordering of Product(s) under this Agreement, Baxter will submit to Oravax, the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trials. The first Baxter Requirements Schedule Agreement shall be submitted to Oravax twelve conducted:
(12A) calendar months before Baxter anticipates requiring on a pull Manufacturing basis in respect of the Manufacture 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 shall cover twelve Exhibit 7 (12Toll Manufacturing Provisions), and
(C) on the fifth (5th) Business Day of each calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no commencing not later than the tenth calendar month following the calendar month in which the Effective Date falls (10thor 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) day 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 calendar monthForecast Schedule align with the requirements of the Gating Plan in respect of such Products, specifying B▇▇▇▇▇’▇ anticipated requirements such volumes shall be deemed to be firm orders binding on the Purchaser and the Supplier, and the quantities included for each Product in calendar monthly periods 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 relevant twelve (12) month period covered by Baxter Requirements Schedule.
5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering Minimum Order Quantity plus one or more multiples of the Minimum Order Quantity. If the volumes specified in the Firm Period of Order do not comply with this requirement then such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall variation to such volumes must be accompanied by purchase orders covering agreed between the relevant amount of each Product indicated Parties as being required in the last month part of the Firm PeriodOrder confirmation process set out at 3.2(E).
5.3 Other than during (D) The Purchaser shall submit each Forecast Schedule either electronically or by such other means that the first four (4) months 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 first Baxter Requirements Schedule for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is Purchaser’s requested Delivery date in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product applicable Lead Time requirements as soon as is reasonably practicable to Baxter set out in Exhibit 1 (“Delivery Date”Products). Oravax shall deliver such Product no later than fourteen (14) days after the Delivery Date.
5.4 No purchase (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 shall request supply Delivery date and the volumes of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments.
5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordinglyrequired. In the event that the Supplier fails to respond to any raw materials have a lead time of longer duration than Firm Order within ten (10) Business Days after acknowledging it, the Firm Period, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order to the extent necessary to coincide with the said lead times.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90) days after the stipulated delivery date shall be the only reasons for which B▇▇▇▇▇ may reject the Products. If B▇▇▇▇▇ wishes to reject any delivery of Product it must notify Oravax within thirty (30) days of receipt of the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ Supplier shall be deemed to have acknowledged and accepted that Firm Order. Unless otherwise agreed by the Product and Parties, the Supplier shall not be entitled obliged to reject acknowledge Firm Orders which comply with the same unless it provides such written notification 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 the said period of thirty ten (3010) days. Oravax shall notify B▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection Business Days confirming whether it accepts B▇▇▇▇▇’▇ claimor rejects such proposed amendments. If Oravax does 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 accept 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 has failed 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 16 (Dispute Escalation), in which case such matter shall be determined in accordance with clause 16 (Dispute Escalation).
(F) The Purchaser, either electronically or by such other means determined by the Manufacturing and Supply Team, shall deliver to Manufacture the Products Supplier purchase orders corresponding to the Product volumes shown in the Firm Orders to such location as reasonably requested by the Supplier in writing. The purchase order shall be in such form as is mutually agreed by the Manufacturing and Supply Team and shall specify the Product(s) and country(ies) to which it relates; have assigned to it a number which shall be used by the Parties in all correspondence relating thereto and shall be submitted in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount of the Product from the Batch or Batches Lead Times set out in dispute. The independent laboratory shall act as expert not arbitrator Exhibit 1 (Products) and the cost of its analysis shall be paid by applicable Firm Zone for the Party against whom Product(s) shown in each Firm Order so that the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from Supplier may process the Batches in question and by Oravax from any samples that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to discuss in good faith the failure of the Batch in question and the resolution of the dispute between themFirm Orders.
5.9 If a (G) The Supplier will supply Product does not conform to the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with Firm Orders that comply with this clause 3.2 and the Specifications applicable Gating Plan and for which the Supplier receives purchase orders in accordance with clause 3.2(F), unless such requirements are changed in accordance with clause 3.2(H) or that any defect did not arise due clause 3.2(I).
(H) Without prejudice to Oravax’s negligence or default Oravax shall have no liability or the Parties’ obligations to B▇▇▇▇▇ in respect of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity Firm Zone of any Forecast Schedule, if discussion of the relevant requirements of a Firm Order is requested by the Supplier, then the relevant planning personnel from both Parties will discuss in good faith, provided that the Supplier shall have no obligation to agree any production schedule or Delivery timetable which would exceed the applicable Gating Volumes for the relevant Product to as set out in the Specifications Gating Plan for that Gating Year.
(I) The Purchaser and the cause thereof, either Supplier shall each establish a single point of them may pursue resolution ordering and forecasting in respect of the dispute through the forum specified in Clause 32.
5.10 If, in any calendar year of this Agreement beginning 2005, the Manufacturing Fees received by Oravax are less than the sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ Products for the amount purposes of the difference between the amount carrying out its obligations under this clause 3.2, subject to any agreed delegation of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay supply and/or invoicing and/or payment to Oravax the amount Nominated Suppliers or other Affiliates of such difference within thirty (30) days of receipt of such noticea Party in accordance with this Agreement.
Appears in 1 contract
Forecasts and Orders. 5.1 During 4.4.1. At least *** days prior to the term first day of each Semiannual Period during the Term, VBI shall deliver to Sanquin a written, good faith *** month forecast of the volume of Product that VBI then anticipates will be required to be produced and delivered to VBI during that *** month period (the “Semiannual Forecast”). The first *** months of the Semiannual Forecast shall contain VBI’s volume requirements for Product by month (the “Firm Portion”), which shall be binding on the Parties. The remaining *** months of the Semiannual Forecast shall contain VBI’s non-binding then-anticipated volume requirements for Product by calendar *** only.
4.4.2. As part of each Firm Portion, VBI shall place firm orders with Sanquin, setting forth Units (or any other measurement agreeable to both Parties), the various countries such Units shall be delivered to, anticipated delivery dates and shipping instructions with respect to each shipment of Product for delivery. Actual supply and shipment shall then take place pursuant to purchase orders which are in a form and according to a working procedure mutually acceptable to VBI and Sanquin and consistent with the terms of this Agreement, Baxter will submit .
4.4.3. Sanquin shall not be obligated to Oravax, accept any Firm Portion to the Baxter Requirements Schedules including any extent the quantity of Product required by Baxter ordered pursuant to carry out clinical trials. The first Baxter Requirements Schedule shall such Firm Portion exceeds ***% of the quantity of Product that was anticipated to be submitted to Oravax twelve (12) calendar months before Baxter anticipates requiring the Manufacture of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than the tenth (10th) day of each calendar month, specifying B▇▇▇▇▇’▇ anticipated requirements for each Product in calendar monthly periods ordered for the relevant twelve (12) month period covered by Baxter Requirements Schedule.
5.2 The first Baxter Requirements Schedule submitted same Semiannual Period according to Oravax the immediately preceding Semiannual Forecast. Notwithstanding the foregoing limitations, Sanquin shall be accompanied by purchase orders covering the Firm Period use commercially reasonable efforts to fill such order for such excess quantities from available supplies, and Sanquin shall use commercially reasonable efforts to notify VBI within *** days after receipt of an order of Sanquin’s ability to fill any amounts of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated as being required order in the last month excess of the Firm Period.
5.3 Other than during the first four (4) months of the first Baxter Requirements Schedule for which Baxter and Oravax quantities that Sanquin is obligated to supply. VBI shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product notify Sanquin as soon as is reasonably practicable to Baxter (“Delivery Date”). Oravax shall deliver such possible of an increase in VBI’s requirements for Product no later than fourteen (14) days after the Delivery Date.
5.4 No purchase order shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products materially in excess of that ordered or contained the limits set forth herein. In any event the quantity of Product required to be supplied by Sanquin to VBI under this Agreement shall in any calendar year not exceed the maximum amount as established for the VBI Portion in the relevant B▇▇▇▇▇ Requirements Capacity Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitmentsfor such year unless agreed otherwise between the Parties.
5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordingly4.4.4. In the event that VBI submits any raw materials have a lead time of longer duration Firm Portion for Product for less than the Firm Period, then Oravax shall, ***% of the quantity of Product that was anticipated to be ordered for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order same Semiannual Period according to the extent necessary immediately preceding Semiannual Forecast, Sanquin nevertheless shall have the right to coincide with the said lead times.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 supply and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass ship to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety VBI (90) days after the stipulated delivery date shall be the only reasons for which B▇▇▇▇▇ may reject the Products. If B▇▇▇▇▇ wishes to reject any delivery of Product it must notify Oravax within thirty (30) days of receipt of the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ shall be deemed to have accepted the Product and shall not be entitled to reject the same unless it provides such written notification within the said period of thirty (30) days. Oravax shall notify B▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection whether it accepts B▇▇▇▇▇’▇ claim. If Oravax does not accept that it has failed to Manufacture the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed shipping instructions most recently supplied by B▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount VBI) ***% of the quantity of Product from set forth in the Batch or Batches immediately preceding Semiannual Forecast for such Semiannual Period. VBI shall notify Sanquin as soon as possible of a decrease in disputeVBI’s requirements for Product materially below the limits set forth herein. The independent laboratory In the event of such a decrease, Sanquin shall act as expert not arbitrator and the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches in question and by Oravax from any samples that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravaxuse commercially reasonable efforts, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet not be required, to discuss in good faith the failure of the Batch in question and the resolution of the dispute between themreduce accordingly.
5.9 If a Product does not conform to 4.4.5. Notwithstanding the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32.
5.10 If, in any calendar year of this Agreement beginning 2005foregoing, the Manufacturing Fees received by Oravax are less than the sum Parties may mutually agree to a forecasting and ordering procedure in advance of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such noticeany Launch.
Appears in 1 contract
Sources: Distribution and Manufacturing Services Agreement (Viropharma Inc)
Forecasts and Orders. 5.1 During (a) Rodel will provide Nanophase with a rolling eighteen-month forecast of the term volume of its Particle requirements at the start of each calendar quarter. The first three months of this forecast shall be firm and accompanied by a purchase order for such forecast. Unless otherwise agreed, Nanophase need not manufacture more than [ * * * ] of the forecasted six-month volume in any single month period. * * * Confidential Portions Omitted and Filed Separately with the Commission
(b) Rodel will give Nanophase six months prior written notice before Nanophase will be obliged to either (i) have installed capacity or manufacture over [ * * * ] of Particles per annum, or (ii) increase production by more than [ * * * ] kilograms of Particles over the production for the previous six-month period. Provided that Nanophase is given such six-month notice, it will be obliged to manufacture up to [ * * * ] kilograms of Particles in the first year of this Agreement.
(c) If Rodel requests that Nanophase commit to manufacture an amount of Particles in excess of [ * * * ] kilograms per annum, the parties will negotiate in good faith a mutually acceptable arrangement for payment of the capital expenditures required in order for Nanophase to manufacture such increased amount. Any failure of Rodel or Nanophase to agree upon such a mutually acceptable arrangement following good faith negotiations shall not constitute either (i) an unwillingness by Nanophase to supply Rodel with Particles under Section 8(a) of this Agreement, Baxter or (ii) a breach of any party's obligations under the Agreement.
(d) Rodel will submit written purchase orders to OravaxNanophase giving reasonable notice which may not be less than three weeks prior to the requested date of shipment and specifying the required quantities, shipment dates, destinations and other relevant information, and Nanophase will use commercially reasonable efforts to fill the Baxter Requirements Schedules orders (including any Product required by Baxter using reasonable commercial efforts to carry out clinical trials. The first Baxter Requirements Schedule fill orders for which Rodel may be unable to provide a full three weeks' notice) so that Rodel may meet its delivery commitments to its customers.
(e) Other provisions applicable to the purchase and sale of the Particles shall be submitted to Oravax twelve (12) calendar months before Baxter anticipates requiring the Manufacture as provided in Rodel's standard terms and conditions of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than the tenth (10th) day of each calendar monthsale, specifying B▇▇▇▇▇’▇ anticipated requirements for each Product in calendar monthly periods for the relevant twelve (12) month period covered by Baxter Requirements Schedule.
5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering the Firm Period of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated as being required in the last month of the Firm Period.
5.3 Other than during the first four (4) months of the first Baxter Requirements Schedule for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product as soon as is reasonably practicable to Baxter (“Delivery Date”). Oravax shall deliver such Product no later than fourteen (14) days after the Delivery Date.
5.4 No purchase order shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments.
5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordingly. In the event that any raw materials have a lead time of longer duration than the Firm Period, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order to the extent necessary to coincide not inconsistent with the said lead times.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Productthis Agreement. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90) days after the stipulated delivery date shall be the only reasons for which B▇▇▇▇▇ may reject the Products. If B▇▇▇▇▇ wishes to reject any delivery of Product it must notify Oravax within thirty (30) days of receipt of the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ shall be deemed to have accepted the Product and shall not be entitled to reject the same unless it provides such written notification within the said period of thirty (30) days. Oravax shall notify B▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection whether it accepts B▇▇▇▇▇’▇ claim. If Oravax does not accept that it has failed to Manufacture the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator and the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches in question and by Oravax from any samples that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to discuss in good faith the failure of the Batch in question and the resolution of the dispute between them.
5.9 If a Product does not conform to the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32.
5.10 If, in any calendar year of this Agreement beginning 2005, the Manufacturing Fees received by Oravax are less than the sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together Confidential Portions Omitted and Filed Separately with the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such notice.Commission
Appears in 1 contract
Sources: Cooperation Agreement (Nanophase Technologies Corporation)
Forecasts and Orders. 5.1 During (a) Prior to the beginning of each calendar month during the term of this Agreement, Baxter will submit Haemacure shall give Immuno a forecast of the orders of Product that Haemacure expects to Oravaxplace with Immuno during each of the next 12 months, using the Baxter Requirements Schedules including any Product required scheduling system employed by Baxter to carry out clinical trialsImmuno. The forecast for the next six months shall constitute firm orders. If the orders vary from the previous forecasts for the six months by more than 10%, Immuno shall use reasonable efforts to fill such orders but shall not be obligated to fill any orders in excess of 10% of the forecasted amount. The forecast for the first Baxter Requirements Schedule 12 month period beginning on the date of Immuno FDA Approval shall be submitted delivered to Oravax twelve (12) calendar months before Baxter anticipates requiring Immuno by Haemacure within 30 days after the Manufacture date of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than the tenth (10th) day of each calendar month, specifying B▇▇▇▇▇’▇ anticipated requirements for each Product in calendar monthly periods for the relevant twelve (12) month period covered by Baxter Requirements Schedulethis Agreement.
5.2 (b) Subject to the provisions of Sections 3(d) and 10 below, Immuno agrees to supply Product pursuant to Haemacure's written orders. Orders shall specify quantities ordered, delivery dates, and delivery and shipping instructions. The first Baxter Requirements Schedule submitted to Oravax obligations and rights of the parties shall be accompanied governed by purchase orders covering the Firm Period terms and conditions of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated as being required in the last month this Agreement, and none of the Firm Period.
5.3 Other than during the first four (4) months of the first Baxter Requirements Schedule for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept general terms set forth on any such purchase order form used by Haemacure or any purchase order received acknowledgment form used by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product as soon as is reasonably practicable to Baxter (“Delivery Date”). Oravax shall deliver such Product no later than fourteen (14) days after the Delivery Date.
5.4 No purchase order shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments.
5.6 Oravax Immuno shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordingly. In the event that any raw materials have a lead time of longer duration than the Firm Periodapplicable, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order to the extent necessary to coincide inconsistent with the said lead timesterms hereof.
5.7 (c) The Products are supplied parties shall cooperate in good faith in providing other, longer range forecasts which shall be useful in budget planning for the parties.
(d) The parties will use all commercially reasonable efforts to allocate Product fairly and equitably to Haemacure, based on the relative potential sales of Tisseel and Tisseel-derived products by Oravax DDU as such term is defined in INCOTERMS 2000 Immuno inside and Oravax shall supply those documents specified in Schedule 4 with each Batch outside the Territory and of Product. Risk Product by Haemacure in the Products Territory, provided that Haemacure shall pass to B▇▇▇▇▇ on delivery. Notwithstanding be allocated the passing lesser of risk, title to each Batch 50% of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90) days after the stipulated delivery date shall be the only reasons for which B▇▇▇▇▇ may reject the Products. If B▇▇▇▇▇ wishes to reject any delivery of Product it must notify Oravax within thirty (30) days of receipt of the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ shall be deemed to have accepted the Product and shall not be entitled to reject the same unless it provides such written notification within the said period of thirty (30) days. Oravax shall notify B▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection whether it accepts B▇▇▇▇▇’▇ claim. If Oravax does not accept that it has failed to Manufacture the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator and the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches in question and by Oravax from any samples that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to discuss in good faith the failure of the Batch in question and the resolution of the dispute between them.
5.9 If a Product does not conform so allocated to the Specifications due to the negligence Territory or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32its firm orders.
5.10 If, in any calendar year of this Agreement beginning 2005, the Manufacturing Fees received by Oravax are less than the sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such notice.
Appears in 1 contract
Forecasts and Orders. 5.1 During (a) ABBI agrees to provide Forecasts, Firm Forecasts and Firm Orders for Products in whole batch increments for each Product by National Drug Code (“NDC”) in accordance with the term procedures set forth in this Section 2.4. AZ shall use commercially reasonable efforts to deliver Products ordered in accordance with timelines set forth in the Firm Orders submitted by ABBI in accordance with this Section 2.4.
(b) ABBI shall submit an initial firm order (“Initial Firm Order”) upon execution of this Agreement for the entire inventory of the Products in final form and labeled for sale in the Territory then held by AZ anywhere in the world on and as of such 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, Baxter 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 submit to Oravax, be delivered on the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trialsdelivery date specified in the Initial Firm Order or as soon thereafter as is commercially reasonable. The first Baxter Requirements Schedule 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”). Such Forecast shall be submitted revised quarterly for a rolling [***] period and delivered to Oravax twelve (12) calendar months before Baxter anticipates requiring AZ on the Manufacture of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than the tenth (10th) first day of each calendar month, specifying B▇▇▇▇▇’▇ anticipated requirements for each Product in calendar monthly periods for the relevant twelve (12) month period covered by Baxter Requirements Schedule.
5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering the Firm Period of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated as being required in the last month of the Firm Period.
5.3 Other than during the first four (4) months of the first Baxter Requirements Schedule for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product as soon as is reasonably practicable to Baxter (“Delivery Date”). Oravax shall deliver such Product no later than fourteen (14) days after the Delivery Date.
5.4 No purchase order shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments.
5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordinglyquarter. In the event that any raw materials have a lead time of longer duration than the Firm Period, then Oravax shalladdition, for the purposes of purchasing such raw materials and allocating production capacityAZ’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 entitled to treat updated on an annual basis on the Forecast as a binding order to anniversary of the extent necessary to coincide with the said lead timesEffective Date of this Agreement.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90d) Within ten (10) business days after the stipulated delivery date Effective Date of 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 only reasons 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 B▇▇▇▇▇ 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 (ii) reject the Productsrequested quantities and initiate dialogue between the Parties to arrive at mutually acceptable values for the Forecast, Firm Forecast and Firm Order. If B▇▇▇▇▇ wishes AZ will use commercially reasonable efforts to reject accommodate any delivery additional quantity of Product it must notify Oravax within thirty (30) days of receipt of Products requested by ABBI after the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ shall be deemed Firm Order has been submitted to have accepted the Product and AZ, but AZ shall not be entitled liable in any respect for its inability to reject do so. Notwithstanding anything in this Agreement to the same unless it provides contrary, AZ shall have no obligation to supply more than [***] of the aggregate volume of each Product by NDC for such written notification within calendar quarter set forth in any Firm Forecast. Firm Orders may be amended only by mutual agreement of the said period Parties, in writing. Furthermore, in the event that ABBI submits a Firm Order for a volume that is less than [***] of thirty (30the volume of any Product(s) days. Oravax by NDC indicated in the Firm Forecast for such calendar quarter, and AZ elects to accept such Firm Order, then AZ shall notify B▇▇▇▇▇ within thirty (30) days of receipt use commercially reasonable efforts to utilize excess Components, Materials and Work in Process as a result of such notification order shortfall for the requirements of rejection whether it accepts B▇▇▇▇▇’▇ claimother Affiliates of AZ or for future periods covered by this Agreement. If Oravax does not accept that it has failed AZ is unable to Manufacture utilize such Components, Materials and Work in Process, then in such case (and only in such case) AZ shall have the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested right to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator and invoice ABBI for the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches all Components, Materials and Work in question and by Oravax from any samples Progress that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to discuss in good faith the failure of the Batch in question and the resolution of the dispute between them.
5.9 If AZ discarded as a Product does not conform to the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect result of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32order shortfall.
5.10 If, in any calendar year of this Agreement beginning 2005, the Manufacturing Fees received by Oravax are less than the sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such notice.
Appears in 1 contract
Sources: Manufacturing and Supply Agreement (Abraxis BioScience, Inc.)
Forecasts and Orders. 5.1 During (a) ABBI agrees to provide Forecasts, Firm Forecasts and Firm Orders for Products in whole batch increments for each Product by National Drug Code ("NDC") in accordance with the term procedures set forth in this Section 2.4. AZ shall use commercially reasonable efforts to deliver Products ordered in accordance with timelines set forth in the Firm Orders submitted by ABBI in accordance with this Section 2.4.
(b) ABBI shall submit an initial firm order ("Initial Firm Order") upon execution of this Agreement for the entire inventory of the Products in final form and labeled for sale in the Territory then held by AZ anywhere in the world on and as of such 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, Baxter 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 submit to Oravax, be delivered on the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trialsdelivery date specified in the Initial Firm Order or as soon thereafter as is commercially reasonable. The first Baxter Requirements Schedule 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"). Such Forecast shall be submitted revised quarterly for a rolling [***] period and delivered to Oravax twelve (12) calendar months before Baxter anticipates requiring AZ on the Manufacture of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than the tenth (10th) first day of each calendar month, specifying B▇▇▇▇▇’▇ anticipated requirements for each Product in calendar monthly periods for the relevant twelve (12) month period covered by Baxter Requirements Schedule.
5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering the Firm Period of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated as being required in the last month of the Firm Period.
5.3 Other than during the first four (4) months of the first Baxter Requirements Schedule for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product as soon as is reasonably practicable to Baxter (“Delivery Date”). Oravax shall deliver such Product no later than fourteen (14) days after the Delivery Date.
5.4 No purchase order shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments.
5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordinglyquarter. In the event that any raw materials have a lead time of longer duration than the Firm Period, then Oravax shalladdition, for the purposes of purchasing such raw materials and allocating production capacityAZ'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 entitled to treat updated on an annual basis on the Forecast as a binding order to anniversary of the extent necessary to coincide with the said lead timesEffective Date of this Agreement.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90d) Within ten (10) business days after the stipulated delivery date Effective Date of 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 only reasons 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 B▇▇▇▇▇ 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 (ii) reject the Productsrequested quantities and initiate dialogue between the Parties to arrive at mutually acceptable values for the Forecast, Firm Forecast and Firm Order. If B▇▇▇▇▇ wishes AZ will use commercially reasonable efforts to reject accommodate any delivery additional quantity of Product it must notify Oravax within thirty (30) days of receipt of Products requested by ABBI after the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ shall be deemed Firm Order has been submitted to have accepted the Product and AZ, but AZ shall not be entitled liable in any respect for its inability to reject do so. Notwithstanding anything in this Agreement to the same unless it provides contrary, AZ shall have no obligation to supply more than [***] of the aggregate volume of each Product by NDC for such written notification within calendar quarter set forth in any Firm Forecast. Firm Orders may be amended only by mutual agreement of the said period Parties, in writing. Furthermore, in the event that ABBI submits a Firm Order for a volume that is less than [***] of thirty (30the volume of any Product(s) days. Oravax by NDC indicated in the Firm Forecast for such calendar quarter, and AZ elects to accept such Firm Order, then AZ shall notify B▇▇▇▇▇ within thirty (30) days of receipt use commercially reasonable efforts to utilize excess Components, Materials and Work in Process as a result of such notification order shortfall for the requirements of rejection whether it accepts B▇▇▇▇▇’▇ claimother Affiliates of AZ or for future periods covered by this Agreement. If Oravax does not accept that it has failed AZ is unable to Manufacture utilize such Components, Materials and Work in Process, then in such case (and only in such case) AZ shall have the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested right to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator and invoice ABBI for the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches all Components, Materials and Work in question and by Oravax from any samples Progress that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to discuss in good faith the failure of the Batch in question and the resolution of the dispute between them.
5.9 If AZ discarded as a Product does not conform to the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect result of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32order shortfall.
5.10 If, in any calendar year of this Agreement beginning 2005, the Manufacturing Fees received by Oravax are less than the sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such notice.
Appears in 1 contract
Sources: Manufacturing Agreement
Forecasts and Orders. 5.1 During 2.2.1 On the term Effective Date of this Agreement, Baxter PURCHASER shall give SELLER written notice of the quantity of Martek Product which PURCHASER estimates in good faith that it will submit order or direct the Designee(s) to Oravax, order from SELLER during the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trialsremainder of the current calendar year (the “Initial Annual Forecast”). The first Baxter Requirements Schedule shall be submitted to Oravax twelve (12) calendar months before Baxter anticipates requiring the Manufacture of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no Not later than the tenth (10th) day November 30 of each calendar monthyear during the Term of this Agreement, specifying B▇▇▇▇▇’▇ anticipated PURCHASER shall give SELLER written notice of the quantity of Martek Product which PURCHASER estimates in good faith that it will order or direct the Designee(s) to * The asterisk denotes that confidential portions of this exhibit have been omitted in reliance on Rule 24b-2 of the Securities Exchange Act of 1934. The confidential portions have been submitted separately to the Securities and Exchange Commission. order from SELLER during the next subsequent calendar year (each, an “Annual Forecast”). The Annual Forecast shall be used to establish the per unit and per kilogram pricing for the Martek Products purchased during the relevant calendar year in accordance with Section 2.3.1 and Exhibit A attached hereto; provided that, for the remainder of calendar year 2006, the per kilogram pricing to be used, subject to the year-end adjustment pursuant to Section 2.3.1, shall be * per kilogram, notwithstanding the Initial Annual Forecast. In addition to the foregoing, one (1) month before the commencement of each calendar quarter during the Term of this Agreement, PURCHASER shall provide SELLER with a forecast (a “Rolling Forecast”) of PURCHASER’s requirements for the Martek Product for each Product in calendar monthly periods for the relevant twelve (12) month period covered by Baxter Requirements Schedule.
5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering the Firm Period of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated as being required in the last month of the Firm Period.
5.3 Other than during the first succeeding four (4) months quarters, specifying quantities and requested delivery dates. These forecasts will be PURCHASER’s good-faith, best estimate of requirements and should not be considered a firm commitment.
2.2.2 PURCHASER expressly acknowledges that available supplies of the first Baxter Requirements Schedule Martek Product have been in the past, and, may from time to time in the future, be insufficient to meet current demand. Nevertheless, SELLER shall use commercially reasonable efforts to have available for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is in accordance with shipment to PURCHASER or to a Designee for PURCHASER’s account such quantities of the Baxter Requirements Schedule and Oravax shall deliver such Martek Product as soon PURCHASER forecasts in good faith pursuant to Section 2.2.1 above and any additional quantities which PURCHASER may reasonably request. In case for any reason SELLER cannot or does not supply such quantities of the Martek Products as is reasonably practicable are forecasted in good faith by PURCHASER pursuant to Baxter Section 2.2.1 to PURCHASER, PURCHASER shall be allowed to use an alternative supplier for quantities of Omega-3 and Omega-6 long-chain polyunsaturated fatty acids equal to those quantities of Martek Products that were ordered by PURCHASER pursuant to a Purchase Order and not delivered by SELLER.
2.2.3 PURCHASER shall issue and/or shall direct the Designee(s) to issue formal purchase orders (“Delivery DatePurchase Orders”). Oravax shall deliver such Product ) at least sixty (60) but no later than fourteen (14) days after the Delivery Date.
5.4 No purchase order shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments.
5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordingly. In the event that any raw materials have a lead time of longer duration than the Firm Period, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order to the extent necessary to coincide with the said lead times.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90) days after in advance of the stipulated delivery date on which PURCHASER or the Designee requests that SELLER ship the Martek Product. SELLER shall accept or reject any such Purchase Order within five (5) business days of receipt, provided that SELLER shall not reject any Purchase Order for any quantities within the most recent forecast.
2.2.4 Purchase Orders which have been accepted by SELLER shall be considered as firm and binding orders (subject to the provisions of Section 2.2.2 above) and shall only reasons for which B▇▇▇▇▇ may reject the Products. If B▇▇▇▇▇ wishes to reject any delivery of Product it must notify Oravax within thirty (30) days of receipt be canceled or amended by mutual written agreement of the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ shall be deemed to have accepted the Product and shall not be entitled to reject the same unless it provides such written notification within the said period of thirty (30) days. Oravax shall notify B▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection whether it accepts B▇▇▇▇▇’▇ claim. If Oravax does not accept that it has failed to Manufacture the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator and the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches in question and by Oravax from any samples that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to discuss in good faith the failure of the Batch in question and the resolution of the dispute between themparties.
5.9 If a Product does not conform to the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32.
5.10 If, in any calendar year of this Agreement beginning 2005, the Manufacturing Fees received by Oravax are less than the sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such notice.
Appears in 1 contract
Forecasts and Orders. 5.1 During 2.2.1 On the term Effective Date of this Agreement, Baxter PURCHASER shall give SELLER written notice of the quantity of Martek Product which PURCHASER estimates in good faith that it will submit order or direct the Designee(s) to Oravax, order from SELLER during the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trialsremainder of the current calendar year (the “Initial Annual Forecast”). The first Baxter Requirements Schedule shall be submitted to Oravax twelve (12) calendar months before Baxter anticipates requiring the Manufacture of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no Not later than the tenth (10th) day November 30 of each calendar monthyear during the Term of this Agreement, specifying B▇▇▇▇▇’▇ anticipated PURCHASER shall give SELLER written notice of the quantity of Martek Product which PURCHASER estimates in good faith that it will order or direct the Designee(s) to order from SELLER during the next subsequent calendar year (each, an “Annual Forecast”). The Annual Forecast shall be used to establish the per unit and per kilogram pricing for the Martek Products purchased during the relevant calendar year in accordance with Section 2.3.1 and Exhibit A attached hereto; provided that, for the remainder of calendar year 2006, the per kilogram pricing to be used, subject to the year-end adjustment pursuant to Section 2.3.1, shall be * per kilogram, notwithstanding the Initial Annual Forecast. In addition to the foregoing, one (1) month before the commencement of each calendar quarter during the Term of this Agreement, PURCHASER shall provide SELLER with a forecast (a “Rolling Forecast”) of PURCHASER’s requirements for the Martek Product for each Product in calendar monthly periods for the relevant twelve (12) month period covered by Baxter Requirements Schedule.
5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering the Firm Period of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated as being required in the last month of the Firm Period.
5.3 Other than during the first succeeding four (4) months quarters, specifying quantities and requested delivery dates. These forecasts will be PURCHASER’s good-faith, best estimate of requirements and should not be considered a firm commitment.
2.2.2 PURCHASER expressly acknowledges that available supplies of the first Baxter Requirements Schedule Martek Product have been in the past, and, may from time to time in the future, be insufficient to meet current demand. Nevertheless, SELLER shall use commercially reasonable efforts to have available for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is in accordance with shipment to PURCHASER or to a Designee for PURCHASER’s account such quantities of the Baxter Requirements Schedule and Oravax shall deliver such Martek Product as soon PURCHASER forecasts in good faith pursuant to Section 2.2.1 above and any additional quantities which PURCHASER may reasonably request. In case for any reason SELLER cannot or does not supply such quantities of the Martek Products as is reasonably practicable are forecasted in good faith by PURCHASER pursuant to Baxter Section 2.2.1 to PURCHASER, PURCHASER shall be allowed to use an alternative supplier for quantities of Omega-3 and Omega-6 long-chain polyunsaturated fatty acids equal to those quantities of Martek Products that were ordered by PURCHASER pursuant to a Purchase Order and not delivered by SELLER.
2.2.3 PURCHASER shall issue and/or shall direct the Designee(s) to issue formal purchase orders (“Delivery DatePurchase Orders”). Oravax shall deliver such Product ) at least sixty (60) but no later than fourteen (14) days after the Delivery Date.
5.4 No purchase order shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments.
5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordingly. In the event that any raw materials have a lead time of longer duration than the Firm Period, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order to the extent necessary to coincide with the said lead times.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90) days after in advance of the stipulated delivery date on which PURCHASER or the Designee requests that SELLER ship the Martek Product. SELLER shall accept or reject any such Purchase Order within five (5) business days of receipt, provided that SELLER shall not reject any Purchase Order for any quantities within the most recent forecast.
2.2.4 Purchase Orders which have been accepted by SELLER shall be considered as firm and binding orders (subject to the provisions of Section 2.2.2 above) and shall only reasons for which B▇▇▇▇▇ may reject the Products. If B▇▇▇▇▇ wishes to reject any delivery of Product it must notify Oravax within thirty (30) days of receipt be canceled or amended by mutual written agreement of the Product and such notification must be in writing and include a detailed indication of the reasons for rejectionparties. B▇▇▇▇▇ shall be deemed to have accepted the Product and shall not be entitled to reject the same unless it provides such written notification within the said period of thirty (30) days* CONFIDENTIAL TREATMENT REQUESTED. Oravax shall notify B▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection whether it accepts B▇▇▇▇▇’▇ claim. If Oravax does not accept that it has failed to Manufacture the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator and the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches in question and by Oravax from any samples that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to discuss in good faith the failure of the Batch in question and the resolution of the dispute between themCONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
5.9 If a Product does not conform to the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32.
5.10 If, in any calendar year of this Agreement beginning 2005, the Manufacturing Fees received by Oravax are less than the sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such notice.
Appears in 1 contract
Forecasts and Orders. 5.1 During The initial forecast for the term Products will be a 24-month non-binding forecast of demand for each Product after the Effective Date for capacity planning purposes, and is attached as Exhibit D. Purchaser shall submit to Seller a purchase order for the initial six (6) months of the initial forecast within five (5) days of the Start Date of this Agreement. Within five (5) days after the beginning of each calendar quarter during the Term of this Agreement, Baxter will submit to Oravax, Purchaser shall provide Seller with a written rolling forecast of Purchaser’s expected requirements for the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trials. The first Baxter Requirements Schedule shall be submitted to Oravax Products during the following twelve (12) calendar months before Baxter anticipates requiring the Manufacture of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than the tenth (10th) day of each calendar month, specifying B▇▇▇▇▇’▇ anticipated requirements for each Product in calendar monthly periods for the relevant twelve (12) month period covered by Baxter Requirements Schedule.
5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering the Firm Period of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated as being required in the last month of the Firm Period.
5.3 Other than during the first four six (46) months of each such forecast shall be binding; and the first Baxter Requirements Schedule amounts set forth for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product as soon as is reasonably practicable to Baxter (“Delivery Date”). Oravax shall deliver such Product no later than fourteen (14) days after the Delivery Date.
5.4 No purchase order shall request supply of Product in respect each of the last month following two (2) calendar quarters shall constitute a non-binding, good faith estimate of that Firm Period the Product requirements of Purchaser for such period for planning purposes only. Seller shall be required to manufacture and deliver to Purchaser such quantities of Products as Purchaser orders in a quantity which differs by more than twenty per cent (20%) from any calendar quarter up to 125% of the quantity specified forecast for the first month of the Forecast contained such calendar quarter in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requested, Oravax will binding forecast. Seller shall use reasonable effortscommercial efforts to manufacture, but with no obligation or have manufactured, and deliver to Purchaser any quantities of Product Purchaser orders in respect excess of 125% of the quantity thereofforecasted for such calendar quarter, but shall be under no obligation to provide to Purchaser any quantities of Product which exceed 125% of the quantity forecasted for such calendar quarter. If Seller becomes aware of any circumstances that may cause Seller to default on its obligation to deliver such quantities of Product as Purchaser orders or to fail to supply to B▇▇▇▇▇ additional Products in excess quantities of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule Product in accordance with this Clause 5 having due regard Purchaser’s forecasts for any calendar quarter, Seller shall give Purchaser prompt written notice describing such circumstances, together with a proposed course of action to Oravax’s production capacity and other manufacturing commitments.
5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordinglyremedy such failure. In the event that any raw materials have of a lead time of longer duration than significant change in market conditions, significant new competitive factors and/or new key customer demands, the Firm Period, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled parties agree to treat the Forecast as a binding order to the extent necessary to coincide with the said lead times.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90) days after the stipulated delivery date shall be the only reasons for which B▇▇▇▇▇ may reject the Products. If B▇▇▇▇▇ wishes to reject any delivery of Product it must notify Oravax within thirty (30) days of receipt of the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ shall be deemed to have accepted the Product and shall not be entitled to reject the same unless it provides such written notification within the said period of thirty (30) days. Oravax shall notify B▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection whether it accepts B▇▇▇▇▇’▇ claim. If Oravax does not accept that it has failed to Manufacture the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator and the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches in question and by Oravax from any samples that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to discuss negotiate in good faith the failure of the Batch in question and the resolution of the dispute between themon appropriate changes to such forecasts.
5.9 If a Product does not conform to the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32.
5.10 If, in any calendar year of this Agreement beginning 2005, the Manufacturing Fees received by Oravax are less than the sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such notice.
Appears in 1 contract
Forecasts and Orders. 5.1 During 5.3.1 At least *** days prior to the term first day of each Semiannual Period during the Term, ViroPharma shall deliver to Sanquin a written, good faith *** month forecast of the volume of ViroPharma Product that ViroPharma then anticipates will be required to be produced and delivered to ViroPharma during that *** month period (the “Semiannual Forecast”). The first *** months of the Semiannual Forecast shall contain ViroPharma’s volume requirements for ViroPharma Product by month (the “Firm Portion”), which shall be binding on the Parties. The remaining *** months of the Semiannual Forecast shall contain ViroPharma’s non-binding then-anticipated volume requirements for ViroPharma Product by calendar *** only.
5.3.2 As part of each Firm Portion, ViroPharma shall place firm orders with Sanquin, setting forth Units (or any other measurement agreeable to both Parties), the various countries such Units shall be delivered to, anticipated delivery dates and shipping instructions with respect to each shipment of ViroPharma Product for delivery. Actual supply and shipment shall then take place pursuant to purchase orders which are in a form and according to a working procedure mutually acceptable to ViroPharma and Sanquin and consistent with the terms of this Agreement.
5.3.3 Sanquin shall not be obligated to accept any Firm Portion to the extent the quantity of ViroPharma Product ordered pursuant to such Firm Portion exceeds ***% of the quantity of ViroPharma Product that was anticipated to be ordered for the same Semiannual Period according to the immediately preceding Semiannual Forecast. Notwithstanding the foregoing limitations, Baxter will submit Sanquin shall use commercially reasonable efforts to Oravaxfill such order for such excess quantities from available supplies, and Sanquin shall use commercially reasonable efforts to notify ViroPharma within *** Business Days after receipt of an order of Sanquin’s ability to fill any amounts of such order in excess of the Baxter Requirements Schedules including any Product required by Baxter quantities that Sanquin is obligated to carry out clinical trialssupply. The first Baxter Requirements Schedule ViroPharma shall be submitted to Oravax twelve (12) calendar months before Baxter anticipates requiring the Manufacture notify Sanquin as soon as possible of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than the tenth (10th) day of each calendar month, specifying B▇▇▇▇▇’▇ anticipated an increase in ViroPharma’s requirements for each ViroPharma Product materially in calendar monthly periods excess of the limits set forth herein. In any event the quantity of ViroPharma Product that Sanquin is obligated to supply to ViroPharma under this Agreement shall in any year not exceed the maximum amount as established for the relevant twelve (12) month period covered by Baxter Requirements ScheduleViroPharma Portion in the Capacity Schedule for such year.
5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering 5.3.4 In the event that ViroPharma submits any Firm Period of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Portion for ViroPharma Product indicated as being required in the last month for less than ***% of the Firm Period.
5.3 Other than during quantity of ViroPharma Product anticipated to be ordered for the first four same Semiannual Period according to immediately preceding Semiannual Forecast, Sanquin nevertheless shall have the right to supply and ship to ViroPharma (4) months of the first Baxter Requirements Schedule for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product as soon as is reasonably practicable to Baxter (“Delivery Date”). Oravax shall deliver such Product no later than fourteen (14shipping instructions most recently supplied by ViroPharma) days after the Delivery Date.
5.4 No purchase order shall request supply of Product in respect ***% of the last month quantity of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first month of the Forecast contained ViroPharma Product set forth in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requestedSemiannual Forecast for such Semiannual Period. ViroPharma shall notify Sanquin as soon as possible of a decrease in ViroPharma’s requirements for ViroPharma Product materially below the limits set forth herein. In the event of such a decrease, Oravax will Sanquin shall use commercially reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments.
5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordingly. In the event that any raw materials have a lead time of longer duration than the Firm Period, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order to the extent necessary to coincide with the said lead times.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90) days after the stipulated delivery date shall be the only reasons for which B▇▇▇▇▇ may reject the Products. If B▇▇▇▇▇ wishes to reject any delivery of Product it must notify Oravax within thirty (30) days of receipt of the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ shall be deemed to have accepted the Product and shall not be entitled required, to reject the same unless it provides such written notification within the said period of thirty (30) days. Oravax shall notify B▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection whether it accepts B▇▇▇▇▇’▇ claim. If Oravax does not accept that it has failed to Manufacture the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator and the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches in question and by Oravax from any samples that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to discuss in good faith the failure of the Batch in question and the resolution of the dispute between themreduce accordingly.
5.9 If a Product does not conform to 5.3.5 Notwithstanding the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32.
5.10 If, in any calendar year of this Agreement beginning 2005foregoing, the Manufacturing Fees received by Oravax are less than the sum Parties may mutually agree to a forecasting and ordering procedure in advance of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such noticea Launch.
Appears in 1 contract
Sources: Manufacturing and Distribution Agreement (Viropharma Inc)
Forecasts and Orders. 5.1 During 4.1 In order that GENSIA SICOR may properly and economically forecast procurement planning with respect to the term Product, PURCHASER shall, commencing with the [ * ] immediately following approval of this Agreementa Cyclosporine Formulation of PURCHASER, Baxter will submit to OravaxGENSIA SICOR within [ * ] business days after the beginning of such [ * ] and ---------------------- * Confidential Treatment Requested; confidential portion has been filed separately with the SEC.
4.1.1 A Firm Order may not be canceled, and, following performance by GENSIA SICOR (for itself and through SICOR, as appropriate) of its obligations hereunder with respect to such order, PURCHASER shall be obligated to pay the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trialsprice for said order as provided in Article 5 hereof. The first Baxter Requirements Schedule shall be submitted to Oravax twelve (12) calendar months before Baxter anticipates requiring the Manufacture of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than the tenth (10th) day of each calendar month, specifying B▇▇▇▇▇’▇ anticipated requirements for each Product in calendar monthly periods for the relevant twelve (12) month period covered by Baxter Requirements Schedule.
5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering the Firm Period of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant total amount of each Product indicated as being required ordered by PURCHASER for delivery in the last month of the Firm Period.
5.3 Other than during the first four (4) months of the first Baxter Requirements Schedule any [ * ] for which Baxter and Oravax shall take Exhibit A into considerationan order is required may not be less than [ * ] percent ([ * ]) of PURCHASER's [ * ] of its [ * ]. In addition, Oravax shall accept any purchase order received by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product as soon as is reasonably practicable GENSIA SICOR's supply obligation will not extend to Baxter (“Delivery Date”). Oravax shall deliver such Product no later than fourteen (14) days after the Delivery Date.
5.4 No purchase order shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent [ * ] percent (20%[ * ]) from the quantity specified for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect PURCHASER's [ * ] of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments.
5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordingly. In the event that any raw materials have a lead time of longer duration than the Firm Period, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order to the extent necessary to coincide with the said lead times.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90) days after the stipulated delivery date shall be the only reasons for which B▇▇▇▇▇ may reject the Productsits [ * ]. If B▇▇▇▇▇ wishes to reject a PURCHASER Product requirement for any delivery quarter exceeds [ * ] of Product it must notify Oravax within thirty (30) days of receipt of the Product PURCHASER's [ * ], GENSIA SICOR and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ shall be deemed to have accepted the Product and shall not be entitled to reject the same unless it provides such written notification within the said period of thirty (30) days. Oravax shall notify B▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection whether it accepts B▇▇▇▇▇’▇ claim. If Oravax does not accept that it has failed to Manufacture the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator and the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches in question and by Oravax from any samples that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to PURCHASER will discuss in good faith the failure of the Batch in question additional amount, if any, that GENSIA SICOR is willing to supply consistent with its other obligations and the resolution of the dispute between themPURCHASER will adjust its order accordingly.
5.9 If a Product does not conform 4.2 The parties shall meet from time to time to review the estimated quantities in each forecast and any Firm Order then outstanding and to consult on matters relating to the Specifications due to the negligence or default scheduling of Oravax then Oravax shall Manufacture manufacture, import and deliver to B▇▇▇▇▇ a sufficient quantity delivery of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect of such Batches. Should B▇▇▇▇▇ but without prejudice and Oravax fail to agree with respect subject to the conformity obligations of the parties set forth in this Agreement.
4.3 Concurrent with execution of this Restated Agreement, Purchaser hereby places Firm Orders (and GENSIA SICOR hereby acknowledges receipt and acceptance of the same on its behalf and by SICOR) for the quantities of the Product to set forth in Exhibit 7 hereto. Notwithstanding the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32.
5.10 If, in any calendar year of this Agreement beginning 2005foregoing, the Manufacturing Fees received by Oravax are less than the sum of (total parties acknowledge that those Firm Orders set forth in Exhibit 7 with a scheduled delivery date after [ * * * * ]) + , are conditioned upon earlier receipt of AADA approval by GENSIA SICOR from the FDA to manufacture Product at its [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such noticefacility.
Appears in 1 contract
Sources: Supply and License Agreement (Sangstat Medical Corp)
Forecasts and Orders. 5.1 During the term 3.1 Forecasting and ordering of Product(s) under this Agreement, Baxter will submit to Oravax, the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trials. The first Baxter Requirements Schedule Agreement shall be submitted to Oravax twelve conducted:
(12A) calendar months before Baxter anticipates requiring on a pull Manufacturing basis in respect of the Manufacture 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 shall cover twelve Exhibit 7 (12Toll Manufacturing Provisions), and
(C) on the fifth (5th) Business Day of each calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no commencing not later than the tenth calendar month following the calendar month in which the Effective Date falls (10thor 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) day 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 calendar monthForecast Schedule align with the requirements of the Gating Plan in respect of such Products, specifying B▇▇▇▇▇’▇ anticipated requirements such volumes shall be deemed to be firm orders binding on the Purchaser and the Supplier, and the quantities included for each Product in calendar monthly periods 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 relevant twelve (12) month period covered by Baxter Requirements Schedule.
5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering Minimum Order Quantity plus one or more multiples of the Minimum Order Quantity. If the volumes specified in the Firm Period of Order do not comply with this requirement then such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall variation to such volumes must be accompanied by purchase orders covering agreed between the relevant amount of each Product indicated Parties as being required in the last month part of the Firm PeriodOrder confirmation process set out at 3.2(E).
5.3 Other than during (D) The Purchaser shall submit each Forecast Schedule either electronically or by such other means that the first four (4) months 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 first Baxter Requirements Schedule for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is Purchaser’s requested Delivery date in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product applicable Lead Time requirements as soon as is reasonably practicable to Baxter set out in Exhibit 1 (“Delivery Date”Products). Oravax shall deliver such Product no later than fourteen (14) days after the Delivery Date.
5.4 No purchase (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 shall request supply Delivery date and the volumes of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments.
5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordinglyrequired. In the event that the Supplier fails to respond to any raw materials have a lead time of longer duration than Firm Order within ten (10) Business Days after acknowledging it, the Firm Period, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order to the extent necessary to coincide with the said lead times.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90) days after the stipulated delivery date shall be the only reasons for which B▇▇▇▇▇ may reject the Products. If B▇▇▇▇▇ wishes to reject any delivery of Product it must notify Oravax within thirty (30) days of receipt of the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ Supplier shall be deemed to have acknowledged and accepted that Firm Order. Unless otherwise agreed by the Product and Parties, the Supplier shall not be entitled obliged to reject acknowledge Firm Orders which comply with the same unless it provides such written notification 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 the said period of thirty ten (3010) days. Oravax shall notify B▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection Business Days confirming whether it accepts B▇▇▇▇▇’▇ claimor rejects such proposed amendments. If Oravax does not accept that it has failed to Manufacture the Products in accordance Purchaser:
(iii) accepts such amendments, the Firm Order together with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax relevant amendments shall be requested deemed to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator be acknowledged and the cost of its analysis shall be paid accepted by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches in question Supplier and by Oravax from any samples that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to 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 failure of the Batch in question and the resolution of the dispute between them.
5.9 If a Product does Parties cannot conform agree an amendment to the Specifications due 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 negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured extent it is in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications this clause 3.2 and the cause thereofapplicable Gating Plan, either of them provided that the Supplier may pursue refer the matter for resolution of the dispute through the forum specified in Clause 32.
5.10 If, in any calendar year of this Agreement beginning 2005, the Manufacturing Fees received by Oravax are less than the sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such notice.accordance with clause
Appears in 1 contract
Forecasts and Orders. 5.1 During (a) ABBI agrees to provide Forecasts, Firm Forecasts and Firm Orders for Products in whole batch increments for each Product by National Drug Code (“NDC”) in accordance with the term procedures set forth in this Section 2.4. AZ shall use commercially reasonable efforts to deliver Products ordered in accordance with timelines set forth in the Firm Orders submitted by ABBI in accordance with this Section 2.4.
(b) ABBI shall submit an initial firm order (“Initial Firm Order”) upon execution of this Agreement for the entire inventory of the Products in final form and labeled for sale in the Territory then held by AZ anywhere in the world on and as of such 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, Baxter 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 submit to Oravax, be delivered on the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trialsdelivery date specified in the Initial Firm Order or as soon thereafter as is commercially reasonable. The first Baxter Requirements Schedule 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”). Such Forecast shall be submitted revised quarterly for a rolling [***] period and delivered to Oravax twelve (12) calendar months before Baxter anticipates requiring AZ on the Manufacture of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than the tenth (10th) first day of each calendar month, specifying B▇▇▇▇▇’▇ anticipated requirements for each Product in calendar monthly periods for the relevant twelve (12) month period covered by Baxter Requirements Schedule.
5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering the Firm Period of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated as being required in the last month of the Firm Period.
5.3 Other than during the first four (4) months of the first Baxter Requirements Schedule for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product as soon as is reasonably practicable to Baxter (“Delivery Date”). Oravax shall deliver such Product no later than fourteen (14) days after the Delivery Date.
5.4 No purchase order shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments.
5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordinglyquarter. In the event that any raw materials have a lead time of longer duration than the Firm Period, then Oravax shalladdition, for the purposes of purchasing such raw materials and allocating production capacityAZ’s long-term planning, ABBI shall provide a non-binding best estimate of [***] forecast of its anticipated quarterly requirements for each Product by NDC, which shall be entitled to treat updated on an annual basis on the Forecast as a binding order to anniversary of the extent necessary to coincide with the said lead timesEffective Date of this Agreement.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90d) Within ten (10) business days after the stipulated delivery date Effective Date of 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 only reasons 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 B▇▇▇▇▇ 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 (ii) reject the Productsrequested quantities and initiate dialogue between the Parties to arrive at mutually acceptable values for the Forecast, Firm Forecast and Firm Order. If B▇▇▇▇▇ wishes AZ will use commercially reasonable efforts to reject accommodate any delivery additional quantity of Product it must notify Oravax within thirty (30) days of receipt of Products requested by ABBI after the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ shall be deemed Firm Order has been submitted to have accepted the Product and AZ, but AZ shall not be entitled liable in any respect for its inability to reject do so. Notwithstanding anything in this Agreement to the same unless it provides contrary, AZ shall have no obligation to supply more than [***] of the aggregate volume of each Product by NDC for such written notification within calendar quarter set forth in any Firm Forecast. Firm Orders may be amended only by mutual agreement of the said period Parties, in writing. Furthermore, in the event that ABBI submits a Firm Order for a volume that is less than [***] of thirty (30the volume of any Product(s) days. Oravax by NDC indicated in the Firm Forecast for such calendar quarter, and AZ elects to accept such Firm Order, then AZ shall notify B▇▇▇▇▇ within thirty (30) days of receipt use commercially reasonable efforts to utilize excess Components, Materials and Work in Process as a result of such notification order shortfall for the requirements of rejection whether it accepts B▇▇▇▇▇’▇ claimother Affiliates of AZ or for future periods covered by this Agreement. If Oravax does not accept that it has failed AZ is unable to Manufacture utilize such Components, Materials and Work in Process, then in such case (and only in such case) AZ shall have the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested right to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator and invoice ABBI for the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches all Components, Materials and Work in question and by Oravax from any samples Progress that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to discuss in good faith the failure of the Batch in question and the resolution of the dispute between them.
5.9 If AZ discarded as a Product does not conform to the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect result of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32order shortfall.
5.10 If, in any calendar year of this Agreement beginning 2005, the Manufacturing Fees received by Oravax are less than the sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such notice.
Appears in 1 contract
Sources: Manufacturing and Supply Agreement (Abraxis BioScience, Inc.)
Forecasts and Orders. 5.1 During the term of this Agreement, Baxter will submit to Oravax, the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trials. The first Baxter Requirements Schedule shall be submitted to Oravax twelve (12) calendar months before Baxter anticipates requiring the Manufacture of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than the tenth (10th) day of each calendar month, specifying B▇▇▇▇▇▇’▇ anticipated requirements for each Product in calendar monthly periods for the relevant twelve (12) month period covered by Baxter Requirements Schedule.
5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering the Firm Period of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated as being required in the last month of the Firm Period.
5.3 Other than during the first four (4) months of the first Baxter Requirements Schedule for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product as soon as is reasonably practicable to Baxter (“Delivery Date”). Oravax shall deliver such Product no later than fourteen (14) days after the Delivery Date.
5.4 No purchase order shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Baxter Requirements Schedule.
5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ Baxter additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Baxter Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments.
5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇▇ and to purchase raw materials and to allocate Back to Contents production capacity accordingly. In the event that any raw materials have a lead time of longer duration than the Firm Period, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order to the extent necessary to coincide with the said lead times.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure delivery .Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety (90) days after the stipulated delivery date shall be the only reasons for which B▇▇▇▇▇▇ may reject the Products. If B▇▇▇▇▇▇ wishes to reject any delivery of Product it must notify Oravax within thirty (30) days of receipt of the Product and such notification must be in writing and include a detailed indication of indicationof the reasons for rejection. B▇▇▇▇▇▇ shall be deemed to have accepted the Product and shall not be entitled to reject the same unless it provides such written notification within the said period of thirty (30) days. Oravax shall notify B▇▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection whether it accepts B▇▇▇▇▇▇’▇ claim. If Oravax does not accept that it has failed to Manufacture the Products in accordance with the Specifications or B▇▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator and the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇▇ from the Batches in question and by Oravax from any samples that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇▇ and Oravax, but upon receipt thereof Breceiptthereof ▇▇▇▇▇▇ and Oravax shall meet to discuss in good faith the failure of the Batch in question and the resolution of the dispute between them.
5.9 If a Product does not conform to the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇▇ in respect of such Batches. Should B▇▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32.
5.10 If, in any calendar year of this Agreement beginning 2005, the Manufacturing Fees received by Oravax are less than the sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such notice.
Appears in 1 contract
Forecasts and Orders. 5.1 During the term of this Agreement3.1 In order to assist Supplier in planning production, Baxter will submit to OravaxNovartis shall, the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trials. The first Baxter Requirements Schedule shall be submitted to Oravax twelve (12) calendar months on or before Baxter anticipates requiring the Manufacture of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than the tenth (10th) day of each calendar month, specifying B▇▇▇▇▇’▇ anticipated requirements for each Product in calendar monthly periods for the relevant provide Supplier with a twelve (12) month period covered rolling forecast of the quantities of Products required by Baxter Requirements Schedule.
5.2 The first Baxter Requirements Schedule submitted Novartis, by month, for the following twelve (12) months. It is understood that such forecasts are intended to Oravax be estimates only, and shall not be binding upon Novartis. Notwithstanding the foregoing, Novartis shall be accompanied by bound to purchase orders covering the Firm Period from Supplier [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of those quantities of Products set forth in each such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated forecast as being required in the last month Novartis' requirements of the Firm Period.
5.3 Other than during Products for the first four three (43) months of the first Baxter Requirements Schedule for which Baxter and Oravax shall take Exhibit A into considerationeach twelve (12) month period. Supplier shall, Oravax shall accept any purchase order received by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product as soon as is reasonably practicable to Baxter (“Delivery Date”). Oravax shall deliver such Product no later than fourteen fifteen (1415) business days after the Delivery Date.
5.4 No receipt of each such forecast, notify Novartis in writing of any prospective problems of which it is aware that might prevent it from meeting Novartis' forecasted order quantities or estimated delivery dates. Unless Supplier so informs Novartis that it would have problems in meeting Novartis' forecasted requirements, Supplier shall be obligated to deliver during any calendar year, pursuant to purchase order orders provided under Section 3.2 of this Agreement, up to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] of Novartis' estimated purchases for that calendar year. Supplier shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified further use its commercially reasonable best efforts to comply with orders for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitmentssuch [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] amount.
5.6 Oravax 3.2 At least [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION***] prior to the date on which Novartis desires to have Product delivered, Novartis shall furnish to Supplier a binding purchase order for the quantity of Products which Novartis shall purchase and Supplier shall deliver. The quantities to be delivered under any such purchase order shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordingly. In the event that any raw materials have a lead time of longer duration than the Firm Period, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order to the extent necessary to coincide with the said lead times.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full batch-size quantities only, and for that Batch a minimum of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than ninety four (90) days after the stipulated delivery date shall be the only reasons for which B▇▇▇▇▇ may reject the Products. If B▇▇▇▇▇ wishes to reject any delivery of Product it must notify Oravax within thirty (30) days of receipt of the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ shall be deemed to have accepted the Product and shall not be entitled to reject the same unless it provides such written notification within the said period of thirty (30) days. Oravax shall notify B▇▇▇▇▇ within thirty (30) days of receipt of such notification of rejection whether it accepts B▇▇▇▇▇’▇ claim. If Oravax does not accept that it has failed to Manufacture the Products in accordance with the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ and Oravax shall be requested to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator and the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches in question and by Oravax from any samples that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to discuss in good faith the failure of the Batch in question and the resolution of the dispute between them.
5.9 If a Product does not conform to the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32.
5.10 If, in any calendar year of this Agreement beginning 2005, the Manufacturing Fees received by Oravax are less than the sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”4), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such notice.
Appears in 1 contract
Sources: Supply Agreement (Cima Labs Inc)
Forecasts and Orders. 5.1 During the term of this Agreement, Baxter will submit to Oravax, the Baxter Requirements Schedules including any Product required by Baxter to carry out clinical trials. The first Baxter Requirements Schedule shall be submitted to Oravax twelve (12a) calendar months before Baxter anticipates requiring the Manufacture of Products and shall cover twelve (12) calendar months. Thereafter Baxter Requirements Schedules will be submitted each month by no later than the tenth (10th) day of each calendar month, specifying B▇▇▇▇▇’▇ anticipated requirements for each Product in calendar monthly periods for the relevant twelve (12) month period covered by Baxter Requirements Schedule.
5.2 The first Baxter Requirements Schedule submitted to Oravax shall be accompanied by purchase orders covering the Firm Period of such Baxter Requirements Schedule. All subsequent Baxter Requirements Schedules submitted shall be accompanied by purchase orders covering the relevant amount of each Product indicated as being required in the last month of the Firm Period.
5.3 Other than during the first four (4) months of the first Baxter Requirements Schedule for which Baxter and Oravax shall take Exhibit A into consideration, Oravax shall accept any purchase order received by Baxter which is in accordance with the Baxter Requirements Schedule and Oravax shall deliver such Product as soon as is reasonably practicable to Baxter (“Delivery Date”). Oravax shall deliver such Product no later than fourteen (14) days after the Delivery Date.
5.4 No purchase order shall request supply of Product in respect of the last month of that Firm Period in a quantity which differs by more than twenty per cent (20%) from the quantity specified for the first month of the Forecast contained in the immediately preceding B▇▇▇▇▇ Requirements Schedule.
5.5 If so requested, Oravax will use reasonable efforts, but with no obligation in respect of the quantity thereof, to supply to B▇▇▇▇▇ additional Products in excess of that ordered or contained in the relevant B▇▇▇▇▇ Requirements Schedule in accordance with this Clause 5 having due regard to Oravax’s production capacity and other manufacturing commitments.
5.6 Oravax shall be entitled to treat the Firm Period as a binding order of B▇▇▇▇▇ and to purchase raw materials and to allocate production capacity accordingly. In the event that any raw materials have a lead time of longer duration than the Firm Period, then Oravax shall, for the purposes of purchasing such raw materials and allocating production capacity, be entitled to treat the Forecast as a binding order to the extent necessary to coincide with the said lead times.
5.7 The Products are supplied by Oravax DDU as such term is defined in INCOTERMS 2000 and Oravax shall supply those documents specified in Schedule 4 with each Batch of Product. Risk in the Products shall pass to B▇▇▇▇▇ on delivery. Notwithstanding the passing of risk, title to each Batch of the Product shall be and remain with Oravax unless and until B▇▇▇▇▇ has paid in full for that Batch of Product supplied hereunder.
5.8 B▇▇▇▇▇ shall inspect and/or test Products as soon as practicable following delivery. Failure by Oravax to Manufacture the Products in accordance with Specifications or delivery by Oravax more than Within ninety (90) days of the date of this Agreement, Jubilant shall provide Trinity with a written list of all APIs manufactured by Jubilant and its Affiliates and that are available for supply by Jubilant to Trigen as Jubilant Products pursuant to this Agreement. Within one hundred twenty (120) days after the stipulated delivery date of this Agreement, (i) Jubilant and Trigen shall agree upon the initial Jubilant Products to be supplied by Jubilant to Trigen pursuant to this Agreement, which Jubilant Products shall be set forth on Schedule A attached hereto and signed by each of the only reasons parties, and (ii) Trigen shall place a binding purchase order for such Jubilant Products for the third calendar quarter of 2005.
(b) Thereafter, not later than thirty (30) business days prior to the start of each calendar quarter during the Term, Trigen shall provide to Jubilant a rolling forecast that estimates the quantity of each Jubilant Product to be purchased by Trigen during the upcoming four calendar quarters. The first calendar quarter of each such forecast will constitute a purchase order from Trigen binding on both parties hereto for the amounts forecasted for each Jubilant Product for such calendar quarter. Except for the first calendar quarter of each such rolling forecast, which B▇▇▇▇▇ may reject constitutes a binding purchase order, such forecast will constitute an estimate of Trigen’s requirements for each Jubilant Product, which is supplied for the Productsconvenience of Jubilant, is non-binding on Trigen, and will not be constitute an order of Jubilant Product.
(c) Trigen shall place orders for the Jubilant Products on Trigen’s standard form purchase order on a calendar quarter basis. If B▇▇▇▇▇ wishes to reject any Each such purchase order must specify each Jubilant Product ordered, the quantity of each Jubilant Product ordered, the place of delivery and the delivery date(s) and the date of Product it shipment which must notify Oravax within not be less than thirty (30) days of receipt of after the Product and such notification must be in writing and include a detailed indication of the reasons for rejection. B▇▇▇▇▇ shall be deemed to have accepted the Product and shall not be entitled to reject the same unless it provides such written notification within the said period of thirty (30) days. Oravax shall notify B▇▇▇▇▇ within thirty (30) days of receipt date of such notification purchase order. In the event of rejection whether it accepts B▇▇▇▇▇’▇ claim. If Oravax does not accept that it has failed to Manufacture a conflict between the Products in accordance with terms and conditions of any purchase order and this Agreement, the Specifications or B▇▇▇▇▇ disagrees then an independent laboratory mutually agreed by B▇▇▇▇▇ terms and Oravax shall be requested to analyse an appropriate amount of the Product from the Batch or Batches in dispute. The independent laboratory shall act as expert not arbitrator and the cost of its analysis shall be paid by the Party against whom the laboratory findings were made. Two samples shall be supplied by B▇▇▇▇▇ from the Batches in question and by Oravax from any samples that it has retained. The results of the said analysis shall be binding on B▇▇▇▇▇ and Oravax, but upon receipt thereof B▇▇▇▇▇ and Oravax shall meet to discuss in good faith the failure of the Batch in question and the resolution of the dispute between them.
5.9 If a Product does not conform to the Specifications due to the negligence or default of Oravax then Oravax shall Manufacture and deliver to B▇▇▇▇▇ a sufficient quantity of the Product to replace the defective Batch or Batches. If B▇▇▇▇▇ accepts that the relevant Batches of Product were Manufactured in accordance with the Specifications or that any defect did not arise due to Oravax’s negligence or default Oravax shall have no liability or obligations to B▇▇▇▇▇ in respect of such Batches. Should B▇▇▇▇▇ and Oravax fail to agree with respect to the conformity of the Product to the Specifications and the cause thereof, either of them may pursue resolution of the dispute through the forum specified in Clause 32.
5.10 If, in any calendar year conditions of this Agreement beginning 2005, the Manufacturing Fees received by Oravax are less than the sum of (total [ * * * * ]) + [ * * * * ] US Dollars (US$[ * * * * ]) (together the “Minimum Payment”), Oravax shall invoice B▇▇▇▇▇ for the amount of the difference between the amount of the Manufacturing Fees for that calendar year and the Minimum Payment and B▇▇▇▇▇ shall pay to Oravax the amount of such difference within thirty (30) days of receipt of such noticewill prevail.
Appears in 1 contract