Forecasts and Orders. Not later than six months after submission of the NDA for a Product or other applicable regulatory filing, IPL will provide ABI with a 12-month forecast of IPL’s requirement for Bulk IFN and ACM, as follows: (a) During the period commencing six months after submission of an NDA, or other applicable regulatory filing, for a Product through the end of the fourth full calendar quarter following the First Commercial Sale of that Product, the forecasts shall be provided quarterly, no less than 45 days prior to the beginning of each quarter. Said requirements will be based on standard production planning parameters, including sales forecasts, sales demand forecasts, promotional forecasts, inventory requirements, and the like. The first two quarters of the 12-month forecast will be stated in monthly requirements. ABI will inform HBL and ask HBL to stock a minimum amount of Bulk IFN and ACM equal to the second two quarters of the 12-month forecast. The first three months of the 12-month forecast will be firm orders to purchase. The second three months will be allowed to be flexed from the previous forecast by plus or minus 25% per month until fixed by the subsequent forecast; provided that the aggregate adjustment from the quantity set forth in the previous forecast for such three-month period shall not exceed 50% in aggregate during that three-month period. For example, if IPL’s forecast for the first three months was for 100 kg ACM and its forecast for the second three months was for 200 kg, the maximum number of kg IPL could order at the time the second three-month period becomes fixed would be 300 kg (i.e., 50% of 200 kg plus the 200 kg originally forecast). The last two quarters of any 12-month forecast will be an estimate and not binding. (b) Following the end of the fourth full calendar quarter following the First Commercial Sale of a Product, IPL will provide to ABI a rolling 12-month forecast for Bulk IFN and ACM with the first three months of the rolling 12-month forecast a firm order to purchase. Each forecast under this subsection (ii) shall be provided monthly, no less than 20 days prior to the beginning of each month. All orders will be for full batch quantities. It is understood that ABI will not maintain inventory in excess of the applicable forecast, but will produce Bulk IFN and ACM upon receipt of that portion of IPL’s forecasts that constitute firm orders to purchase. Nothing in this Agreement shall obligate ABI to deliver Bulk IFN and ACM if HBL is unable for any reason to provide them. IPL agrees to purchase a sufficient amount of Bulk IFN and ACM to enable IPL to carry sufficient inventory to allow for fluctuations in sales demand so as to allow ABI reasonable lead-time to meet increased demand. ABI will use commercially reasonable efforts to meet any increase in demand in excess of the allowed adjustment, but will not be obligated to do so. All forecasts will be made by IPL to ABI in good faith based upon standard commercial parameters. From time to time after the Effective Date, the Parties shall consider whether, in light of market demand, manufacturing capacity, inventory levels and other pertinent factors, to revise the schedule for delivery of forecasts and, if appropriate, negotiate in good faith to revise such schedule.
Appears in 1 contract
Sources: License and Supply Agreement (Amarillo Biosciences Inc)
Forecasts and Orders. Not later than six months after submission of the NDA for a Product or other applicable regulatory filingfiling on a country-by-country basis, IPL GKI will provide ABI with a 12-12 month forecast of IPL’s GKI's requirement of each Product, which forecast will include designation of whether such Product shall be provided in bulk or Unit form, for Bulk IFN and ACMwhich an NDA, or other applicable regulatory filing, has been submitted, on a Product basis, as follows:
(a) During the period commencing six months after submission of an NDA, or other applicable regulatory filing, for a Product through the end of the fourth full calendar quarter following the First Commercial Sale of that Product, the forecasts shall be provided quarterly, no less than 45 days prior to the beginning of each quarter. Said requirements will be based on standard production planning parameters, including sales forecasts, sales demand forecasts, promotional forecasts, inventory requirements, and the like. The first two quarters of the 12-12 month forecast will be stated in monthly requirements. ABI will inform HBL and ask HBL to stock a minimum amount of Bulk IFN and ACM equal to the The second two quarters of the 12-12 month forecastforecast will be total requirement by stock keeping unit and will be stated as quarterly requirements. The first three months of the 12-12 month forecast will be firm orders to purchase. The second three months will be allowed to be flexed from the previous forecast by plus or minus 25% per month until fixed by the subsequent forecast; provided that the aggregate adjustment from the quantity set forth in the previous forecast for such three-three month period shall not exceed 50% in aggregate during that three-three month period. For example, if IPL’s GKI's forecast for the first three months was for 100 kg ACM Units and its forecast for the second three months was for 200 kgUnits, the maximum number of kg IPL Units GKI could order at the time the second three-three month period becomes fixed would be 300 kg Units (i.e., 50% of 200 kg Units plus the 200 kg Units originally forecast). The last two quarters of any 12-12 month forecast will be an estimate and not binding.
(b) Following the end of the fourth full calendar quarter following the First Commercial Sale of a Product, IPL GKI will provide to ABI a rolling 12-12 month forecast for Bulk IFN and ACM each Product with the first three months of the rolling 12-12 month forecast a firm order to purchase. Each forecast under this subsection (ii) shall be provided monthly, no less than 20 days prior to the beginning of each month. All orders will be for full batch quantities. It is understood that ABI will not maintain Product inventory in excess of the applicable forecast, but will produce Bulk IFN and ACM Product upon receipt of that portion of IPL’s GKI's forecasts that constitute firm orders to purchase. Nothing in this Agreement shall obligate ABI to deliver Bulk IFN and ACM Product if HBL is unable for any reason to provide themProduct. IPL GKI agrees to purchase a sufficient amount of Bulk IFN and ACM Product to enable IPL GKI to carry sufficient inventory to allow for fluctuations in sales demand so as to allow ABI reasonable lead-time to meet increased demand. ABI will use commercially reasonable efforts to meet any increase in demand in excess of the allowed adjustment, but will not be obligated to do so. All forecasts will be made by IPL GKI to ABI in good faith based upon standard commercial parameters. From time to time after the Effective Date, the Parties shall consider whether, in light of market demand, manufacturing capacity, inventory levels and other pertinent factors, to revise the schedule for delivery of forecasts and, if appropriate, negotiate in good faith to revise such schedule.. Confidential ------------ **** Indicates that a portion of the text has been omitted and filed separately with the Commission. 24
Appears in 1 contract
Sources: License and Supply Agreement (Amarillo Biosciences Inc)
Forecasts and Orders. Not later than six months after submission of 4.1 For the NDA period up to 30 June 2010, the non-binding forecast attached as Annex I will apply. Beginning with the twelve (12) month period starting on 1 July 2010, and for a Product or other applicable regulatory filingeach consecutive twelve (12) month period thereafter, IPL will Customer shall provide ABI Manufacturer with a written twelve (12-) month forecast of IPL’s requirement its estimated orders for Bulk IFN and ACMProduct and/or Intermediates, as follows:
if any (a) During the period commencing six months after submission of an NDA, or other applicable regulatory filing, for each a Product through the end of the fourth full calendar quarter following the First Commercial Sale of that Product, the forecasts “Forecast”). Each Forecast shall be provided quarterly, no less than 45 delivered to Manufacturer at least sixty (60) days prior to the beginning of each quarterthe applicable twelve (12) month period. Said requirements will be based on standard production planning parametersEach Forecast is a non-binding estimate and shall not obligate Customer to purchase the volume of Product and/or Intermediates set forth in it; provided, including sales forecastshowever, sales demand forecasts, promotional forecasts, inventory requirements, and the like. The first two quarters that eighty percent (80%) of the aggregate volume forecasted in such Forecast shall be binding upon Customer and Customer shall deliver Orders to Manufacturer pursuant to clauses 4.3 and 4.4 (each, an “Order”) during such twelve (12-) month forecast will be stated period for quantities of Product and/or Intermediates which, in monthly requirements. ABI will inform HBL and ask HBL the aggregate, amount to stock a minimum amount at least the binding portion of Bulk IFN and ACM equal such Forecast.
4.2 For the Forecast covering the period from 1 July 2010 to 30 June 2011, although the second two quarters aggregate quantities actually ordered during such twelve (12) month period may exceed one hundred fifty percent (150%) of the 12-month forecast. The first three months of the 12-month forecast will be firm orders to purchase. The second three months will be allowed to be flexed from the previous forecast by plus or minus 25% per month until fixed by the subsequent forecast; provided that the aggregate adjustment from the quantity amounts set forth in the previous Forecast, the supply obligations of Manufacturer shall not exceed one hundred twenty percent (120%) of the aggregate amounts forecast for such three-twelve (12) month period. The Manufacturer shall use its reasonable endeavours to supply any Product and/or Intermediate that is in excess of one hundred twenty percent (120%) but less than one hundred fifty percent (150%) of the aggregate amount set forth in the Forecast, and if it is unable to do so, the Manufacturer’s only obligation with respect to such excess portion over one hundred twenty percent (120%) is to inform the Customer as soon as reasonably practicable, but in any event within ten (10) days of receipt of the applicable Order, of Manufacturer’s inability to supply, and the Customer may at its option agree an alternative delivery date for such excess.
4.3 For each Forecast covering the period from 1 July 2011 to 30 June 2012, and each subsequent consecutive twelve (12) month period thereafter, although the aggregate quantities actually ordered may exceed one hundred twenty percent (120%) of the aggregate amounts set forth in such Forecast, the supply obligations of Manufacturer shall not exceed 50% in one hundred twenty percent (120%) of the aggregate during that three-amount forecast for such twelve (12) month period. For example, if IPL’s forecast for the first three months was for 100 kg ACM and The Manufacturer shall use its forecast for the second three months was for 200 kg, the maximum number of kg IPL could order at the time the second three-month period becomes fixed would be 300 kg (i.e., 50% of 200 kg plus the 200 kg originally forecast). The last two quarters of reasonable endeavours to supply any 12-month forecast will be Product and/or Intermediate set forth in an estimate and not binding.
(b) Following the end of the fourth full calendar quarter following the First Commercial Sale of a Product, IPL will provide to ABI a rolling 12-month forecast for Bulk IFN and ACM with the first three months of the rolling 12-month forecast a firm order to purchase. Each forecast under this subsection (ii) shall be provided monthly, no less than 20 days prior to the beginning of each month. All orders will be for full batch quantities. It Order that is understood that ABI will not maintain inventory in excess of one hundred twenty percent (120%) of the amount set forth in the Forecast for such month, but if it is unable to do so, the Manufacturer’s only obligation with respect to such excess portion is to inform the Customer as soon as reasonably practicable, but in any event within ten (10) days of receipt of the applicable forecastOrder, but will produce Bulk IFN of Manufacturer’s inability to supply, and ACM upon receipt the Customer may at its option agree an alternative delivery date for such excess.
4.4 Customer shall order Product and/or Intermediate by submitting either written purchase orders, in such form as the Parties shall agree from time to time or the order placement function of Customer, and each electronic submission of such an order shall constitute an Order placed by Customer with Manufacturer. Each Order shall specify the quantities of Product and/or Intermediates ordered, and the desired delivery date for such Product and/or Intermediate in accordance with the terms of this Agreement. Unless otherwise agreed by the Parties, Customer shall order Product and/or Intermediate in lots of a defined number of units/lot pursuant to each Order in not less than the minimum batch size or its multiples, of each Product and/or Intermediate set out in Annex C. Except as set forth in clause 4.8, or as otherwise agreed by the Parties, any Order for less than the minimum batch size shall be deemed to be for the minimum batch size.
4.5 Manufacturer shall make each delivery of Product and/or Intermediate in the quantity and on the delivery date specified for it on Customer’s Order to the Party specified on such Order. Manufacturer shall address each delivery with the delivery point set forth in the applicable Order. Any Order for Product and/or Intermediate submitted by Customer to Manufacturer shall reference this Agreement and shall be governed exclusively by the terms contained herein. The Parties hereby agree that portion the terms and conditions of IPL’s forecasts that constitute firm orders to purchase. Nothing in this Agreement shall obligate ABI supersede any term or condition in any Order, confirmation or other document furnished by either Party to the other Party that is in any way in addition to or inconsistent with these terms and conditions.
4.6 Once a firm Order for Products and/or Intermediates has been received and accepted by the Manufacturer from the Customer, it shall be irrevocable and may be modified only as mutually agreed to by both Parties.
4.7 The Customer shall order Products and/or Intermediates from the Manufacturer on the basis of firm Orders to be placed at least ninety (90) days in advance of required delivery dates, provided however that any such days falling within the months of August or December shall not be counted when calculating such ninety (90) day period.
4.8 To support the Customer’s efforts to transfer production of certain products to the Customer’s facility, if agreed to by the Parties, the Manufacturer will supply Intermediates to the Customer in quantities less than the minimum batch size at the prices listed in Annex E.
4.9 Subject to clause 4.2 and 4.3, Manufacturer shall deliver Bulk IFN and ACM if HBL is unable for any reason 100% of the Product and/or Intermediates set forth in an Order with a range of tolerance equal to +/- 5% within five days following, or one day prior to, the date specified on the applicable Order. Should the Manufacturer more than once during rolling twelve (12) month period fail to provide them. IPL agrees to purchase a sufficient amount of Bulk IFN and ACM to enable IPL to carry sufficient inventory to allow for fluctuations in sales demand so as to allow ABI reasonable lead-time to meet increased demand. ABI will use commercially reasonable efforts to meet any increase in demand in excess quantity of the allowed adjustment, but will Product and/or Intermediates ordered with an Order placed for forecasted quantity and not be obligated to do so. All forecasts will be made by IPL to ABI in good faith based upon standard commercial parameters. From time to time cure such default within ninety (90) days after the Effective Datedate of such failure, then the Parties Customer reserves the right to take any or all of the following actions:.
a) arrange for direct expedited routing of the Product and/or Intermediates (with the entire cost of such expedited routing to be borne by Manufacturer); or
b) terminate the Order upon Notice to Manufacturer and purchase substitute Product and/or Intermediate from another supplier. Such Product and/or Intermediate purchased from another supplier shall consider whether, in light count towards the total quantity with respect to the binding forecast requirements of market demand, manufacturing capacity, inventory levels and other pertinent factors, to revise the schedule for delivery of forecasts and, if appropriate, negotiate in good faith to revise such scheduleclause 4.1.
Appears in 1 contract
Forecasts and Orders. Not later than six months after submission of the NDA for a Product or other applicable regulatory filingfiling on a country-by-country basis, IPL CYTO will provide ABI with a 12-month forecast of IPLCYTO’s requirement of each Product, which forecast will include designation of whether such Product shall be provided in bulk or Unit form, for Bulk IFN and ACMwhich an NDA, or other applicable regulatory filing, has been submitted, on a Product basis, as follows:
(a) During the period commencing six months after submission of an NDA, or other applicable regulatory filing, for a Product through the end of the fourth full calendar quarter following the First Commercial Sale of that Product, the forecasts shall be provided quarterly, no less than 45 days prior to the beginning of each quarter. Said requirements will be based on standard production planning parameters, including sales forecasts, sales demand forecasts, promotional forecasts, inventory requirements, and the like. The first two quarters of the 12-month forecast will be stated in monthly requirements. ABI will inform HBL and ask HBL to stock a minimum amount of Bulk IFN and ACM Product equal to the second two quarters of the 12-month forecast. The first three months of the 12-month forecast will be firm orders to purchase. The second three months will be allowed to be flexed from the previous forecast by plus or minus 25% per month ****Indicates that a portion of the text has been omitted and filed separately with the Commission until fixed by the subsequent forecast; provided that the aggregate adjustment from the quantity set forth in the previous forecast for such three-month period shall not exceed 50% in aggregate during that three-month period. For example, if IPLCYTO’s forecast for the first three months was for 100 kg ACM Units and its forecast for the second three months was for 200 kgUnits, the maximum number of kg IPL Units CYTO could order at the time the second three-month period becomes fixed would be 300 kg Units (i.e., 50% of 200 kg Units plus the 200 kg Units originally forecast). The last two quarters of any 12-month forecast will be an estimate and not binding.
(b) Following the end of the fourth full calendar quarter following the First Commercial Sale of a Product, IPL CYTO will provide to ABI a rolling 12-month forecast for Bulk IFN and ACM each Product with the first three months of the rolling 12-month forecast a firm order to purchase. Each forecast under this subsection (ii) shall be provided monthly, no less than 20 days prior to the beginning of each month. All orders will be for full batch quantities. It is understood that ABI will not maintain Product inventory in excess of the applicable forecast, but will produce Bulk IFN and ACM Product upon receipt of that portion of IPLCYTO’s forecasts that constitute firm orders to purchase. Nothing in this Agreement shall obligate ABI to deliver Bulk IFN and ACM Product if HBL is unable for any reason to provide themProduct. IPL CYTO agrees to purchase a sufficient amount of Bulk IFN and ACM Product to enable IPL CYTO to carry sufficient inventory to allow for fluctuations in sales demand so as to allow ABI reasonable lead-time to meet increased demand. ABI will use commercially reasonable efforts to meet any increase in demand in excess of the allowed adjustment, but will not be obligated to do so. All forecasts will be made by IPL CYTO to ABI in good faith based upon standard commercial parameters. From time to time after the Effective Date, the Parties shall consider whether, in light of market demand, manufacturing capacity, inventory levels and other pertinent factors, to revise the schedule for delivery of forecasts and, if appropriate, negotiate in good faith to revise such schedule.
Appears in 1 contract
Sources: License and Supply Agreement (Amarillo Biosciences Inc)
Forecasts and Orders. (a) Not later than six months after following submission of the NDA for a Product or other applicable regulatory filingfiling on a country-by-country basis, IPL Atrix will provide ABI with a 12-12 month forecast of IPL’s Atrix's requirement of each Product, which forecast will include designation of whether such Product shall be provided in bulk or Unit form, for Bulk IFN and ACMwhich an NDA, or other applicable regulatory filing, has been submitted, on a Product-by-Product basis, as follows:
(ai) During the period commencing six months after following submission of an NDA, or other applicable regulatory filing, for a Product through the end of the fourth full calendar quarter following the First Commercial Sale of that Product, the forecasts shall be provided quarterly, no less than 45 days prior to the beginning of each quarter. Said requirements will be based on standard production planning parameters, including sales forecasts, sales demand forecasts, promotional forecasts, inventory requirements, and the like. The first two quarters of the 12-12 month forecast will be stated in monthly requirements. ABI will inform HBL and ask HBL to stock a minimum amount of Bulk IFN and ACM equal to the The second two quarters of the 12-12 month forecastforecast will be total requirement by stock keeping unit and will be stated as quarterly requirements. The first three months of the 12-12 month forecast will be firm orders to purchase. The second three months will be allowed to be flexed from the previous **** Indicates that a portion of the text has been omitted Confidential forecast by plus or minus 25% per month until fixed by the subsequent forecast; provided that the aggregate adjustment from the quantity set forth in the previous forecast for such three-three month period shall not exceed 50% in aggregate during that three-three month period. For example, if IPL’s Atrix's forecast for the first three months was for 100 kg ACM Units and its forecast for the second three months was for 200 kgUnits, the maximum number of kg IPL Units Atrix could order at the time the second three-three month period becomes fixed would be 300 kg Units (i.e., 50% of 200 kg Units plus the 200 kg Units originally forecast). The last two quarters of any 12-12 month forecast will be an estimate and not binding.
(bii) Following the end of the fourth full calendar quarter following the First Commercial Sale of a Product, IPL Atrix will provide to ABI a rolling 12-12 month forecast for Bulk IFN and ACM each Product with the first three months of the rolling 12-12 month forecast a firm order to purchase. Each forecast under this subsection (ii) shall be provided monthly, no less than 20 days prior to the beginning of each month. All orders will be for full batch quantities. .
(b) It is understood that ABI will not maintain Product inventory in excess of the applicable forecast, but will produce Bulk IFN and ACM Product upon receipt of that portion of IPL’s Atrix's forecasts that constitute firm orders to purchase. Nothing in this Agreement shall obligate ABI to deliver Bulk IFN and ACM if HBL is unable for any reason to provide them. IPL agrees to purchase a sufficient amount of Bulk IFN and ACM to enable IPL to carry sufficient inventory to allow for fluctuations in sales demand so as to allow ABI reasonable lead-time to meet increased demand. ABI will use commercially reasonable efforts to meet any increase in demand in excess of the allowed adjustment, but will not be obligated to do so. All forecasts will be made by IPL to ABI in good faith based upon standard commercial parameters. From time to time after the Effective Date, the Parties shall consider whether, in light of market demand, manufacturing capacity, inventory levels and other pertinent factors, to revise the schedule for delivery of forecasts and, if appropriate, negotiate in good faith to revise such schedule.
Appears in 1 contract
Forecasts and Orders. Not later than six months after submission of the NDA for a Product or other applicable regulatory filing, IPL CYTOB will provide ABI AMAR with a 12-month forecast of IPLCYTOB’s requirement of each Product, which forecast will include designation of whether such Product shall be provided in bulk or Unit form, for Bulk IFN and ACMwhich an NDA, or other applicable regulatory filing, has been submitted, on a Product basis, as follows:
(a) During the period commencing six months after submission of an NDA, or other applicable regulatory filing, for a Product through the end of the fourth full calendar quarter following the First Commercial Sale of that Product, the forecasts shall be provided quarterly, no less than 45 days prior to the beginning of each quarter. Said requirements will be based on standard production planning parameters, including sales forecasts, sales demand forecasts, promotional forecasts, inventory requirements, and the like. The first two quarters of the 12-month forecast will be stated in monthly requirements. ABI AMAR will inform HBL and ask HBL to stock a minimum amount of Bulk IFN and ACM Product equal to the second two quarters of the 12-month forecast. The first three months of the 12-month forecast will be firm orders to purchase. The second three months will be allowed to be flexed from the previous forecast by plus or minus 25% _____% per month until fixed by the subsequent forecast; provided that the aggregate adjustment from the quantity set forth in the previous forecast for such three-month period shall not exceed 50_____% in aggregate during that three-month period. For example, if IPLCYTOB’s forecast for the first three months was for 100 kg ACM _____ Units and its forecast for the second three months was for 200 kg_____ Units, the maximum number of kg IPL Units CYTOB could order at the time the second three-month period becomes fixed would be 300 kg _____ Units (i.e., 50_____% of 200 kg _____ Units plus the 200 kg _____ Units originally forecast). The last two quarters of any 12-month forecast will be an estimate and not binding.
(b) Following the end of the fourth full calendar quarter following the First Commercial Sale of a Product, IPL CYTOB will provide to ABI AMAR a rolling 12-month forecast for Bulk IFN and ACM each Product with the first three months of the rolling 12-month forecast a firm order to purchase. Each forecast under this subsection (ii) shall be provided monthly, no less than 20 days prior to the beginning of each month. All orders will be for full batch quantities. It is understood that ABI AMAR will not maintain inventory in excess of the applicable forecast, but will produce Bulk IFN and ACM upon receipt of that portion of IPL’s forecasts that constitute firm orders to purchaseProduct inventory. Nothing in this Agreement shall obligate ABI AMAR to deliver Bulk IFN and ACM if HBL is unable for any reason to provide themstock Product. IPL CYTOB agrees to purchase a sufficient amount of Bulk IFN and ACM Product to enable IPL CYTOB to carry sufficient inventory to allow for fluctuations in sales demand so as to allow ABI AMAR reasonable lead-time to meet increased demand. ABI AMAR will use commercially reasonable efforts to meet any increase in demand in excess of the allowed adjustment, but will not be obligated to do so. All forecasts will be made by IPL CYTOB to ABI AMAR in good faith based upon standard commercial parameters. From time to time after the Effective Date, the Parties shall consider whether, in light of market demand, manufacturing capacity, inventory levels and other pertinent factors, to revise the schedule for delivery of forecasts and, if appropriate, negotiate in good faith to revise such schedule.
Appears in 1 contract
Sources: License and Supply Agreement (Amarillo Biosciences Inc)
Forecasts and Orders. Not later than six months after submission of the NDA for a Product or other applicable regulatory filingfiling on a country-by-country basis, IPL BME will provide ABI with a 12-month forecast of IPL’s BME's requirement of each Product, which forecast will include designation of whether such Product shall be provided in bulk or Unit form, for Bulk IFN and ACMwhich an NDA, or other applicable regulatory filing, has been submitted, on a Product basis, as follows:
(a) During the period commencing six months after submission of an NDA, or other applicable regulatory filing, for a Product through the end of the fourth full calendar quarter following the First Commercial Sale of that Product, the forecasts shall be provided quarterly, no less than 45 days prior to the beginning of each quarter. Said requirements will be based on standard production planning parameters, including sales forecasts, sales demand forecasts, promotional forecasts, inventory requirements, and the like. The first two quarters of the 12-month forecast will be stated in monthly requirements. ABI will inform HBL and ask HBL to stock a minimum amount of Bulk IFN and ACM equal to the The second two quarters of the 12-month forecastforecast will be total requirement by stock keeping unit and will be stated as quarterly requirements. The first three months of the 12-month forecast will be firm orders to purchase. The second three months will be allowed to be flexed from the previous forecast by plus or minus 25% per month until fixed by the subsequent forecast; provided that the aggregate adjustment from the quantity set forth in the previous forecast for such three-month period shall not exceed 50% in aggregate during that three-month period. For example, if IPL’s BME's forecast for the first three months was for 100 kg ACM Units and its forecast for the second three months was for 200 kgUnits, the maximum number of kg IPL Units BME could order at the time the second three-month period becomes fixed would be 300 kg Units (i.e., 50% of 200 kg Units plus the 200 kg Units originally forecast). The last two quarters of any 12-month forecast will be an estimate and not binding.
(b) Following the end of the fourth full calendar quarter following the First Commercial Sale of a Product, IPL BME will provide to ABI a rolling 12-month forecast for Bulk IFN and ACM each Product with the first three months of the rolling 12-month forecast a firm order to purchase. Each forecast under this subsection (ii) shall be provided monthly, no less than 20 days prior to the beginning of each month. All orders will be for full batch quantities. **** Indicates that a portion of the text has been omitted and filed separately with the Commission. It is understood that ABI will not maintain Product inventory in excess of the applicable forecast, but will produce Bulk IFN and ACM Product upon receipt of that portion of IPL’s BME's forecasts that constitute firm orders to purchase. Nothing in this Agreement shall obligate ABI to deliver Bulk IFN and ACM Product if HBL is unable for any reason to provide themProduct. IPL BME agrees to purchase a sufficient amount of Bulk IFN and ACM Product to enable IPL BME to carry sufficient inventory to allow for fluctuations in sales demand so as to allow ABI reasonable lead-time to meet increased demand. ABI will use commercially reasonable efforts to meet any increase in demand in excess of the allowed adjustment, but will not be obligated to do so. All forecasts will be made by IPL BME to ABI in good faith based upon standard commercial parameters. From time to time after the Effective Date, the Parties shall consider whether, in light of market demand, manufacturing capacity, inventory levels and other pertinent factors, to revise the schedule for delivery of forecasts and, if appropriate, negotiate in good faith to revise such schedule.
Appears in 1 contract
Sources: License and Supply Agreement (Amarillo Biosciences Inc)
Forecasts and Orders. Not later than six months after submission of the NDA for a Product or other applicable regulatory filing, IPL will provide ABI with a 12-month forecast of IPL’s requirement for Bulk IFN and ACM, as follows:
(a) During Dentsply shall provide Forecasts and Firm Orders for Products in whole Batches in accordance with the period commencing six months after submission of an NDA, or other applicable regulatory filing, for a procedures set forth in Section 2.3(b). AZ shall use commercially reasonable efforts to deliver Product through the end of the fourth full calendar quarter following the First Commercial Sale of that Product, the forecasts shall be provided quarterly, no less than 45 days prior to the beginning of each quarter. Said requirements will be based on standard production planning parameters, including sales forecasts, sales demand forecasts, promotional forecasts, inventory requirements, and the like. The first two quarters of the 12-month forecast will be stated in monthly requirements. ABI will inform HBL and ask HBL to stock a minimum amount of Bulk IFN and ACM equal to the second two quarters of the 12-month forecast. The first three months of the 12-month forecast will be firm orders to purchase. The second three months will be allowed to be flexed from the previous forecast by plus or minus 25% per month until fixed by the subsequent forecast; provided that the aggregate adjustment from the quantity accordance with timelines set forth in the previous forecast for such three-month period shall not exceed 50% Firm Orders submitted by Dentsply as set forth in aggregate during that three-month period. For example, if IPL’s forecast for the first three months was for 100 kg ACM and its forecast for the second three months was for 200 kg, the maximum number of kg IPL could order at the time the second three-month period becomes fixed would be 300 kg (i.e., 50% of 200 kg plus the 200 kg originally forecastSection 2.3(b). The last two quarters of any 12-month forecast will be an estimate and not binding.
(b) Following Commencing on December 1, 2003 (the end of the fourth full calendar quarter following the First Commercial Sale of a Product"Initial Forecast Date"), IPL Dentsply will provide to ABI AZ a forecast of Dentsply's requirements in Batches for each Product for each month for a twelve (12) month period (a "Forecast"); provided, however, that from the Initial Forecast Date until the Effective Date, each Forecast shall reflect Dentsply's requirements for the twelve-month period beginning on the Effective Date. Such Forecast shall be revised monthly for (i) a rolling twelve (12-) month forecast for Bulk IFN and ACM period, or (ii) through the remaining period to termination of this Agreement, with the first three months (3) months' forecast in each twelve (12) month period beginning on December 1, 2003 reflected in the form of a firm, non-cancelable purchase order (a "Firm Order"). The maximum monthly quantity specified in the Forecast or Firm Order shall not exceed 17 Batches (63,750 Sales Units) per month as the total for all Products. The minimum monthly quantity specified in the Forecast or Firm Order shall not be less than 12 Batches (45,000 Sales Units) per month as the total for all Products. For the term of this Agreement, should Dentsply provide a Firm Order that is below the minimum monthly quantity, AZ will invoice Dentsply as if the minimum monthly quantity of Sales Units of the highest priced Product had been Manufactured; provided, however, that Dentsply may provide a Firm Order that is below the minimum monthly quantity of Batches for the month during which AZ conducts its annual shutdown of the Facility or for a month that AstraZeneca determines it can not provide such minimum quantity due to a decrease in available capacity such as equipment maintenance or SAP software installation. AZ will notify Dentsply in writing of the month that such shutdown is to occur at least three (3) months prior to the first day of such month.
(c) AZ will respond within 10 business days of receiving from Dentsply the monthly rolling 12-month forecast a firm order to purchase. Each forecast under this subsection Forecast and Firm Order and will either (i) confirm acceptance by AZ of the Forecast and Firm Order quantities or (ii) shall be provided monthly, no less than 20 days prior reject the requested quantities and initiate a dialogue between the Parties to arrive at mutually acceptable values for the beginning of each monthForecast and Firm Order. All orders will be for full batch quantities. It is understood that ABI will not maintain inventory in excess of the applicable forecast, but will produce Bulk IFN and ACM upon receipt of that portion of IPL’s forecasts that constitute firm orders to purchase. Nothing in this Agreement shall obligate ABI to deliver Bulk IFN and ACM if HBL is unable for any reason to provide them. IPL agrees to purchase a sufficient amount of Bulk IFN and ACM to enable IPL to carry sufficient inventory to allow for fluctuations in sales demand so as to allow ABI reasonable lead-time to meet increased demand. ABI AZ will use commercially reasonable efforts to meet accommodate any increase in demand in excess additional quantity of Products requested by Dentsply after the allowed adjustmentFirm Order has been sent to AZ, but will AZ shall not be obligated liable in any respect for its inability to do so. All forecasts will Notwithstanding anything in this Agreement to the contrary, AZ shall have no obligation to Manufacture in any month more than 17 Batches in total for all Products, and AZ shall have no obligation to Manufacture any quantity of Products during the specified shutdown month. Firm Orders may be made amended only by IPL to ABI in good faith based upon standard commercial parameters. From time to time after mutual agreement of the Effective Date, the Parties shall consider whetherParties, in light of market demand, manufacturing capacity, inventory levels and other pertinent factors, to revise the schedule for delivery of forecasts and, if appropriate, negotiate in good faith to revise such schedulewriting.
Appears in 1 contract
Sources: Manufacturing Agreement (Dentsply International Inc /De/)