Forecasts Orders Delivery and Acceptance. 10.1 No later than six months prior to the anticipated Launch date for Product in the Territory and by the fifth day of each month thereafter, Almirall shall prepare and provide GW Pharma with a written forecast of its total requirement for Product (unlabelled anonymous vials) for at least the following eighteen (18) months (“Forecast”). Against the Product Forecast Almirall will formally call off the respective quantities in line with the Product Firm Order process described in Clause 10.3. 10.2 No later than six months prior to the anticipated Launch date for Presentation in each Territory and by the fifth day of each month thereafter, Almirall shall prepare and provide GW Pharma with a written forecast of its total requirements for Presentation (being finished Labelled and Packaged Product for country) for at least the following eighteen (18) months (“Forecast”). Against the Presentation Forecast Almirall will formally call off the respective quantities in line with the Presentation Firm Order process described in Clause 10.4. 10.3 The quantities of Products detailed in the first *** months of each Product Forecast (“Product Firm Order Period”) shall constitute a binding commitment on Almirall to purchase such quantities of Product from GW Pharma on the terms and conditions of this Agreement (“Product Firm Order”). With respect to the total requirement for Product, Almirall shall issue to GW Pharma by the fifth Business Day of each month a Product Firm Order for the quantity of Product (unlabelled anonymous vials) required in the fourth month of the Product Forecast. For the avoidance of doubt the first Product Firm Order will consist of a quantity of Product ordered for the *** month *** months ***. The Parties agree that all Firm Orders for the Products placed by Almirall under this Agreement shall be supplied on the terms of this Agreement. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 10.4 The quantities of Presentations detailed in the first month of each Presentation Forecast (“Presentation Firm Order Period”) shall constitute a binding commitment on Almirall to purchase such quantities of the Presentations from GW Pharma on the terms and conditions of this Agreement (“Presentation Firm Order”). With respect to the total requirement for Presentation, Almirall shall issue to GW Pharma by the tenth Business Day of each month a Presentation Firm Order for the quantity of Presentations (being finished Labelled and Packaged Product for country) required in the following month of that Presentation Forecast. The sum of the Presentation Firm Order quantities to be Labelled and Packaged shall be no greater than the total Product Firm Order for that month as described in Clause 10.3. The quantities to be Labelled, the ‘labelling plan’, will be documented and attached as part of the Presentation Firm Order. 10.5 In determining Product Firm Order quantities, Almirall shall take account of manufacturing batch sizes, such that Almirall must accept as fulfilled orders actual quantities of Products manufactured which are within a margin of *** percent (***%) of the Product Firm Order quantity. In the event GW Pharma manufactures Product quantities in an aggregated shortfall *** percent (***%), then GW Pharma shall be obliged to make up such shortfall quantities as early as possible. GW Pharma shall notify Almirall of the initial manufacturing batch size for the Products six (6) months in advance of anticipated Launch. 10.6 In determining Presentation Firm Order quantities and the labelling plan, Almirall shall take account of labelling batch sizes of *** (subject to GW Pharma confirmation), such that Almirall must accept as fulfilled orders actual quantities of labelled Presentations which are within a *** percent (***%) of the Presentation Firm Order quantity. In the event GW Pharma supplies quantities in an aggregated shortfall of *** percent (***%), then GW Pharma shall be obliged to make up such shortfall quantities as early as possible. GW Pharma shall notify Almirall of the minimum labelling batch size for the Presentations six months in advance of anticipated launch. 10.7 Almirall agrees to discuss (via conference call) with GW Pharma on a monthly basis, *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. no later than the 10th Business Day of the month, the latest Forecasts sent by Almirall, for each Territory. The purpose of this discussion is for Almirall to explain changes made to the Forecasts and to highlight any future developments in the Territory that may affect future Forecasts. GW Pharma will document the monthly demand management discussion and send a summary of the discussion to Almirall within 5 Business Days thereof. GW Pharma will also review whether the latest Forecasts raise any issues regarding GW Pharma’s ability to supply Product to meet anticipated future demand. If potential issues arise GW Pharma will respond to Almirall within thirty (30) days with an action plan responding to the issues. 10.8 In addition to the requirements of Clause 9.4.1 GW Pharma shall hold sufficient stocks of both CBD Botanical Drug Substance and THC Botanical Drug Substance to meet the Forecast requirements during the Product Firm Order Period and up to *** percent (***%) of the Product Forecast requirements detailed in the months ***. For clarity, this means that GW Pharma shall hold sufficient stocks of CBD Botanical Drug Substance and THC Botanical Drug Substance in bulk form to cover the Firm Order Period ***% of the demand for months *** but in any event shall hold stocks of CBD Botanical Drug Substance and THC Botanical Drug Substance in bulk form necessary to manufacture a volume of Product equal to or greater than the total volume of Almirall’s Firm Orders for the previous six (6) months. Both Parties shall conduct their businesses so as to minimise any stock write-offs. 10.9 GW Pharma shall hold, at GW Pharma’s cost, safety stocks of printed packaging components as agreed with Almirall. These safety stock targets shall be reviewed on a monthly basis, in the light of monthly Presentation Forecast, and any changes shall be documented as part of the demand management process described in Clause 10.7. Any write off of printed packaging materials is as agreed under Clause 14.4.1 and 14.4.2. 10.10 Almirall may ask GW Pharma for additional quantities to be manufactured and delivered by GW Pharma during the Firm Order Period. GW Pharma shall use its reasonable efforts to comply with Almirall’s additional demand. In any case GW Pharma shall give notice to Almirall within ten (10) Business Days of the receipt of the written order of its ability to meet such additional quantity. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 10.11 It is understood that volumes detailed in each Forecast for the months following the Firm Order Period constitute a good faith estimate of future requirement of Product by Almirall, its Affiliates and distributors and do not comprise a minimum purchase requirement or a binding commitment on Almirall. Almirall recognises that GW Pharma will commit to resources and materials against the Forecast and that these decisions rely on GW Pharma understanding the future demands using the process described in Clause 10.4. 10.12 GW Pharma shall respond to each Firm Order received from Almirall within three (3) Business Days of receipt. The response shall include confirmation of the quantity set out in the Firm Order and the date by which GW Pharma will be able to deliver the Product. In the event that discussion is required regarding the timing of delivery then the relevant personnel from both Parties will negotiate in good faith and agree and confirm in writing an amended Firm Order within four (4) Business Days of receipt by GW Pharma of the original Firm Purchase Order except during the period 20th December to 6th January in each Year when the periods of three (3) or four (4) Business Days referred to herein shall be replaced by eight (8) Business Days in each case. 10.13 All Product supplied under this Agreement shall be delivered FCA (Incoterms 2000) *** premises located in *** and shall be accompanied by a written Certificate of Analysis and Release confirming that such quantity of Product meets the Specification, a Packing-list and an insurance policy. GW Pharma shall secure transport and insurance, from Wockhardt to Sant Andreu de la Barca (Barcelona) or its nominee’s facility in Europe, with its own providers at Almirall’s cost and expense. Almirall shall pay all freight, insurance charges, taxes, import and export duties, inspection fees and other charges applicable to the sale and transport of Product purchased by Almirall hereunder which amounts shall be separately set forth on GW Pharma’s invoices to Almirall. Title and risk of loss and damage to Product purchased by Almirall hereunder shall pass to Almirall upon collection of the Product by the Third Party carrier. 10.14 Almirall has the right, at anytime and in an order-by-order basis, to secure transport or insurance with its own Almirall providers, by communicating such decision to GW *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Pharma in the correspondent Presentation Firm order. 10.15 Following receipt of a shipment of Product from GW Pharma, Almirall or its designated agent shall, within five (5) days, carry out a visual inspection (as defined below) of such shipment to ensure that Packaging and Labelling of Product has taken place in accordance with the Specification and is accompanied by an associated Certificate of Analysis and if Almirall determines in its sole discretion (exercised reasonably) that it has not so taken place it shall promptly notify rejection of shipment to GW Pharma in writing. Subject to the provisions of Clause 10.16, if Almirall does not notify GW Pharma of rejection of such shipment within such five (5) days, such shipment of Product shall be deemed to have been accepted. 10.16 For the purposes of this Agreement, “visual inspection” shall mean: 10.16.1 comparing the applicable order against the documentation accompanying the shipment to verify that the delivery date, identity, quantity and exterior shipment labelling comply with the order; 10.16.2 verifying that the Certificate of Analysis for the shipment states that the Product conforms in all material respects to the applicable Specifications; 10.16.3 visually inspecting the exterior of the shipment of Products to verify that the shipment appears to be in good condition; and 10.16.4 verifying that the temperature of the shipment has remained within specification by reviewing the data logger information. For the avoidance of doubt, visual inspection does not include laboratory analysis. 10.17 Notwithstanding the foregoing, GW Pharma shall remain liable to Almirall to the extent provided in Clause 10.19 or 10.20 as appropriate for any latent defect that subsequently is discovered which renders the Product unsaleable, if such defect is due to the failure of Product to meet Specification and/or GMP and provided that Almirall immediately inform GW Pharma by notice in writing of such defect and rejection of the relevant shipment not later than ten (10) Business Days from the date of discovery of such latent defect. 10.18 Within 10 days of receipt by GW Pharma of a notice of rejection from Almirall in accordance with Clauses 10.15 or 10.17 GW Pharma shall indicate in writing to Almirall whether GW Pharma is issuing a return authorisation or not. In the event that a return authorisation is so issued Almirall shall return to GW Pharma at GW Pharma’s expense the quantities of Product in question and GW Pharma shall replace such quantities within twenty (20) Business Days or as soon as reasonably practicable thereafter. If the payment in respect of such quantities is outstanding, it shall be postponed until such replacement quantities are received and accepted by Almirall in accordance with this Clause 10. 10.19 After receipt of any rejection notice from Almirall pursuant to Clause 10.15 or Clause 10.17 if GW Pharma does not issue a return authorisation under Clause 10.17 GW Pharma shall analyse any batch of Product rejected by Almirall for non-conformity with the Specifications within twenty (20) Business Days of receipt of such notice, and present its findings with respect to such Product to Almirall. If such tests confirm non-conformity with the Specification GW Pharma shall promptly supply to Almirall (at GW Pharma’s cost and expense) a conforming batch in the same quantity as the rejected batch and shall reimburse Almirall for any out of pocket costs or expenses incurred by Almirall including shipping charges in relation to such non-conforming batch. If the Parties cannot agree on whether the batch of Product in question conforms to the Specifications, an independent qualified laboratory reasonably acceptable to both Parties, and at a cost equally shared by both Parties, shall analyse both Almirall’s and GW Pharma’s samples of Product in question, and the definitive results of such laboratory shall be binding on the Parties. If the batch of Product in question is determined to be non-conforming, such non-conforming Product shall be held for GW Pharma’s disposition, or shall be returned to GW Pharma, in each case at GW Pharma’s expense, as directed by GW Pharma no later than ten (10) Business Days following such determination. GW Pharma shall replace each non-conforming batch of Product, or the non-conforming portion thereof, with conforming Product within twenty (20) Business Days or as soon as reasonably practical after receipt of notice of rejection thereof. If the batch of Product in question is determined to be conforming and provided that the Certificate of Analysis did not indicate it to be non-conforming, such Product shall be returned to Almirall at Almirall’s cost and expense. 10.20 GW Pharma shall employ stock rotation methods and techniques consistent with Good Industry Practice so as to ensure that Product delivered to Almirall has a minimum of seventy-five per cent (75%) of its shelf life unexpired, provided the approved shelf-life is at least of sixteen (16) months. Almirall has the right to reject any Product with less than *** months of remaining shelf-life and save as otherwise agreed between the parties pursuant to Clause 9.5. 10.21 The Parties agree that the costs of recall shall be met as follows: if a recall arises due to any act or omission by Almirall the Cost of Manufacture, distribution expenses and third-party recall expenses (collectively, the “Recall Costs”) shall be borne by Almirall; if a recall arises from any other reason then the Recall Costs shall be borne by GW Pharma. Almirall shall maintain records of all sales of Product and customers sufficient for Almirall or GW Pharma (as appropriate) to adequately administer a recall for the period required by Applicable Law.
Appears in 2 contracts
Sources: Product Commercialisation and Supply Agreement (Gw Pharmaceuticals PLC), Product Commercialisation and Supply Agreement (Gw Pharmaceuticals PLC)
Forecasts Orders Delivery and Acceptance. 10.1 No After the signing of this Agreement and no later than six months one hundred and twenty (120) calendar days prior to the anticipated Launch launch date for a Product in the Territory and by in September in September on or before the fifth 15th day of January, April, July and September ofin each month thereafterYear after such launch, Almirall CMS shall prepare and provide GW Pharma Norgine with a non-binding, written rolling forecast of its by calendar month for the next two (2) Years and specify, by calendar month, CMS’s total requirement requirements for Product and CMS’s requirements (unlabelled anonymous vialsby quantity) for at least the following eighteen (18) months Product Packaged and Labelled for the Territory (“Forecast”). Against the Product Forecast Almirall will formally call off the respective quantities in line , including, with the Product Firm Order process described in Clause 10.3.
10.2 No later than six months prior respect to the first Forecast, the period between the anticipated Launch launch date for Presentation in each Territory and by the fifth day end of the second first yYear following launch. CMS shall be obligedhave a binding commitment to purchase from Norgine no less than 80% of the forecasted quantity of each month thereafterProduct monthly, Almirall and Norgine shall prepare and provide GW Pharma with a written forecast be obliged to supply to CMS no less than 120% of its total requirements for Presentation (being finished Labelled and Packaged the forecasted quantity of each Product for country) for at least the following eighteen (18) months (“Forecast”). Against the Presentation Forecast Almirall will formally call off the respective quantities in line with the Presentation Firm Order process described in Clause 10.4.
10.3 The quantities of Products monthly, as detailed in the first *** months first year Quarter Year following the Year Quarter year of submission of each Product Forecast (“Product Firm Order Period”) shall constitute a binding commitment on Almirall to purchase such quantities of Product from GW Pharma on the terms and conditions of this Agreement Agreement. CMS shall issue to Norgine formal purchase orders (one (1) for each delivery) four at two least five(5) months in advance showing the total quantity of Product required in each calendar month of such Year year . Provided that CMS requires for more, by no later than 120%the first day of December of the forecasted quantity of each Product as detailed in the first year of Forecast for certain month, CMS shall notify Norgine of its requirements six month in advance by writing and Nogine shall exert it best commercial effort to satisfy such requirements.the Quarteryear preceding the calendar year in which the Product is required (each a “Product Firm Purchase Order”). With respect The amounts set forth in the second Year each of the Quarters second year of each Forecast shall constitute CMS’s non-binding, good faith estimate of CMS’s requirements of each Product for each country for such periods. Without prejudice to the total requirement for Productprovisions of Clause 9.2, Almirall CMS shall issue to GW Pharma by the fifth Business Day of each month a Product Firm Order for the quantity of Product (unlabelled anonymous vials) required in the fourth month provide Norgine with Purchase Orders which specify quantities of the Product Forecastwhich are eighty five percent (85%) or more of the corresponding Forecasted quantity. For Norgine shall not be obliged to accept the avoidance of doubt the first Product Firm Order will consist quantities of a quantity Product specified in the Purchase Order in excess of Product ordered one hundred and twenty percent (120%) the quantities specified in the previous Forecasts for the *** such calendar month *** months ***. The Parties agree that all Firm as specified above and without prior notice of CMS subject to Clause 9.2.Purchase Orders for the Products placed by Almirall under this Agreement shall be supplied on the terms of this Agreement. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
10.4 The quantities of Presentations detailed in the first month of each Presentation Forecast (“Presentation Firm Order Period”) shall constitute a binding commitment on Almirall to purchase such CMS which specify quantities of the Presentations from GW Pharma on the terms Product that are one hundred and conditions of this Agreement twenty percent (“Presentation Firm Order”). With respect to the total requirement for Presentation, Almirall shall issue to GW Pharma by the tenth Business Day of each month a Presentation Firm Order for the quantity of Presentations (being finished Labelled and Packaged Product for country120%) required in the following month of that Presentation Forecast. The sum or more of the Presentation Firm Order quantities to be Labelled and Packaged shall be no greater than the total Product Firm Order for that month as described in Clause 10.3. The quantities to be Labelled, the ‘labelling plan’, will be documented and attached as part of the Presentation Firm Order.
10.5 In determining Product Firm Order quantities, Almirall shall take account of manufacturing batch sizes, such that Almirall must accept as fulfilled orders actual quantities of Products manufactured which are within a margin of *** percent (***%) of the Product Firm Order corresponding Forecasted quantity. In the event GW Pharma manufactures Product quantities in an aggregated shortfall *** percent (***%), then GW Pharma CMS shall be obliged to make up such shortfall quantities as early as possible. GW Pharma shall notify Almirall of the initial manufacturing batch size for the Products provide Norgine with six (6) months notice in advance in writing of any such change and, subject to acceptance by Norgine shall exert its best commercial effort to adjust, the Forecast shall be adjusted accordingly. Each Purchase Order shall be for a total amount of each Product which is a compete multiple of Norgine’s batch size. Norgine shall have no obligation to supply any quantities of any Product in the event CMS places orders for total amounts of that Product or amounts of Packaged and Labelled Product that are not complete multiples of Norgine’s standard manufacturing batch size for that Product. At the Effective Date Norgine’s batch size is seventy six thousand (76,000) Units. Norgine will inform CMS of any changes to its batch size, from time to time, and a reasonable period of time in advance of anticipated Launch.
10.6 In determining Presentation Firm Order quantities and the labelling plan, Almirall shall take account of labelling batch sizes of *** (subject to GW Pharma confirmation), such that Almirall must accept as fulfilled orders actual quantities of labelled Presentations which are within implementing a *** percent (***%) of the Presentation Firm Order quantity. In the event GW Pharma supplies quantities in an aggregated shortfall of *** percent (***%), then GW Pharma shall be obliged to make up such shortfall quantities as early as possible. GW Pharma shall notify Almirall of the minimum labelling batch size for the Presentations six months in advance of anticipated launch.
10.7 Almirall agrees to discuss (via conference call) with GW Pharma on a monthly basis, *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. no later than the 10th Business Day of the month, the latest Forecasts sent by Almirall, for each Territory. The purpose of this discussion is for Almirall to explain changes made change to the Forecasts and to highlight any future developments in the Territory that may affect future Forecastsbatch size. GW Pharma will document the monthly demand management discussion and send a summary of the discussion to Almirall within 5 Business Days thereof. GW Pharma will also review whether the latest Forecasts raise any issues regarding GW Pharma’s ability to supply Product to meet anticipated future demand. If potential issues arise GW Pharma will respond to Almirall within thirty (30) days with an action plan responding to the issues.
10.8 In addition to the requirements of Clause 9.4.1 GW Pharma shall hold sufficient stocks of both CBD Botanical Drug Substance and THC Botanical Drug Substance to meet the Forecast requirements during the Product Firm Order Period and up to *** percent (***%) of the Product Forecast requirements detailed in the months ***. For clarity, this means that GW Pharma shall hold sufficient stocks of CBD Botanical Drug Substance and THC Botanical Drug Substance in bulk form to cover the Firm Order Period ***% of the demand for months *** but in any event shall hold stocks of CBD Botanical Drug Substance and THC Botanical Drug Substance in bulk form necessary to manufacture a volume of Product equal to or greater than the total volume of Almirall’s Firm Orders for the previous six (6) months. Both Parties shall conduct their businesses so Upon delivery by Norgine as to minimise any stock write-offs.
10.9 GW Pharma shall hold, at GW Pharma’s cost, safety stocks of printed packaging components as agreed with Almirall. These safety stock targets shall be reviewed on a monthly basis, in the light of monthly Presentation Forecast, and any changes shall be documented as part of the demand management process described in Clause 10.7. Any write off of printed packaging materials is as agreed under Clause 14.4.1 and 14.4.2.
10.10 Almirall may ask GW Pharma for additional quantities to be manufactured and delivered by GW Pharma during the Firm Order Period. GW Pharma shall use its reasonable efforts to comply with Almirall’s additional demand. In any case GW Pharma shall give notice to Almirall within ten (10) Business Days of the receipt of the written order of its ability to meet such additional quantity. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
10.11 It is understood that volumes detailed in each Forecast for the months following the Firm Order Period constitute a good faith estimate of future requirement of Product by Almirall, its Affiliates and distributors and do not comprise a minimum purchase requirement or a binding commitment on Almirall. Almirall recognises that GW Pharma will commit to resources and materials against the Forecast and that these decisions rely on GW Pharma understanding the future demands using the process described in Clause 10.4.
10.12 GW Pharma shall respond to each Firm Order received from Almirall within three (3) Business Days of receipt. The response shall include confirmation of the quantity set out in the Firm Order Clauses 9.6 and the date by which GW Pharma will be able to deliver the Product. In the event that discussion is required regarding the timing of delivery then the relevant personnel from both Parties will negotiate in good faith and agree and confirm in writing an amended Firm Order within four (4) Business Days of receipt by GW Pharma of the original Firm Purchase Order except during the period 20th December to 6th January in each Year when the periods of three (3) or four (4) Business Days referred to herein shall be replaced by eight (8) Business Days in each case.
10.13 All Product supplied under this Agreement shall be delivered FCA (Incoterms 2000) *** premises located in *** and shall be accompanied by a written Certificate of Analysis and Release confirming that such quantity of Product meets the Specification9.7, a Packing-list and an insurance policy. GW Pharma shall secure transport and insurance, from Wockhardt to Sant Andreu de la Barca (Barcelona) or its nominee’s facility in Europe, with its own providers at Almirall’s cost and expense. Almirall shall pay all freight, insurance charges, taxes, import and export duties, inspection fees and other charges applicable to the sale and transport of Product purchased by Almirall hereunder which amounts shall be separately set forth on GW Pharma’s invoices to Almirall. Title and risk of loss and damage to Product purchased by Almirall hereunder shall pass to Almirall upon collection of the Product by the Third Party carrier.
10.14 Almirall has the right, at anytime and in an ordershall have a minimum of 85% (eighty-by-order basis, to secure transport or insurance with its own Almirall providers, by communicating such decision to GW *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Pharma in the correspondent Presentation Firm order.
10.15 Following receipt of a shipment of Product from GW Pharma, Almirall or its designated agent shall, within five (5) days, carry out a visual inspection (as defined belowpercent) of such shipment to ensure that Packaging and Labelling of Product has taken place in accordance with the Specification and its total shelf-life which is accompanied by an associated Certificate of Analysis and if Almirall determines in its sole discretion (exercised reasonably) that it has not so taken place it shall promptly notify rejection of shipment to GW Pharma in writing. Subject to the provisions of Clause 10.16, if Almirall does not notify GW Pharma of rejection of such shipment within such five (5) days, such shipment of Product shall be deemed to have been accepted.
10.16 For the purposes of this Agreement, “visual inspection” shall mean:
10.16.1 comparing the applicable order against the documentation accompanying the shipment to verify that the delivery date, identity, quantity and exterior shipment labelling comply with the order;
10.16.2 verifying that approved on the Certificate of Analysis for the shipment states that the Product conforms in all material respects to the applicable Specifications;
10.16.3 visually inspecting the exterior of the shipment of Products to verify that the shipment appears to be in good condition; and
10.16.4 verifying that the temperature of the shipment has remained within specification by reviewing the data logger information. For the avoidance of doubtAnalysis, visual inspection does not include laboratory analysis.
10.17 Notwithstanding the foregoing, GW Pharma shall remain liable to Almirall to the extent provided in Clause 10.19 or 10.20 as appropriate for any latent defect that subsequently is discovered which renders the Product unsaleable, if such defect is due to the failure of Product to meet Specification and/or GMP and provided that Almirall immediately inform GW Pharma by notice in writing of such defect and rejection of the relevant shipment not later than ten (10) Business Days from the date of discovery of such latent defect.
10.18 Within 10 days of receipt by GW Pharma of unless a notice of rejection from Almirall in accordance with Clauses 10.15 or 10.17 GW Pharma shall indicate in writing to Almirall whether GW Pharma is issuing a return authorisation or not. In the event that a return authorisation is so issued Almirall shall return to GW Pharma at GW Pharma’s expense the quantities of Product in question and GW Pharma shall replace such quantities within twenty (20) Business Days or as soon as reasonably practicable thereafter. If the payment in respect of such quantities is outstanding, it shall be postponed until such replacement quantities are received and accepted by Almirall in accordance with this Clause 10.
10.19 After receipt of any rejection notice from Almirall pursuant to Clause 10.15 or Clause 10.17 if GW Pharma does not issue a return authorisation under Clause 10.17 GW Pharma shall analyse any batch of Product rejected by Almirall for non-conformity with the Specifications within twenty (20) Business Days of receipt of such notice, and present its findings with respect to such Product to Almirall. If such tests confirm non-conformity with the Specification GW Pharma shall promptly supply to Almirall (at GW Pharma’s cost and expense) a conforming batch in the same quantity as the rejected batch and shall reimburse Almirall for any out of pocket costs or expenses incurred by Almirall including shipping charges in relation to such non-conforming batch. If the Parties cannot agree on whether the batch of Product in question conforms to the Specifications, an independent qualified laboratory reasonably acceptable to both Parties, and at a cost equally shared by both Parties, shall analyse both Almirall’s and GW Pharma’s samples of Product in question, and the definitive results of such laboratory shall be binding on the Parties. If the batch of Product in question is determined to be non-conforming, such non-conforming Product shall be held for GW Pharma’s disposition, or shall be returned to GW Pharma, in each case at GW Pharma’s expense, as directed by GW Pharma no later than ten (10) Business Days following such determination. GW Pharma shall replace each non-conforming batch of Product, or the non-conforming portion thereof, with conforming Product within twenty (20) Business Days or as soon as reasonably practical after receipt of notice of rejection thereof. If the batch of Product in question is determined to be conforming and provided that the Certificate of Analysis did not indicate it to be non-conforming, such Product shall be returned to Almirall at Almirall’s cost and expense.
10.20 GW Pharma shall employ stock rotation methods and techniques consistent with Good Industry Practice so as to ensure that Product delivered to Almirall has a minimum of seventy-five per cent (75%) of its short shelf life unexpired, provided the approved shelf-life is at least of sixteen (16) months. Almirall has the right to reject any Product with less than *** months of remaining shelf-life and save as otherwise agreed between the parties pursuant to Clause 9.5Parties with the prior written consent of CMS.
10.21 The Parties agree that the costs of recall shall be met as follows: if a recall arises due to any act or omission by Almirall the Cost of Manufacture, distribution expenses and third-party recall expenses (collectively, the “Recall Costs”) shall be borne by Almirall; if a recall arises from any other reason then the Recall Costs shall be borne by GW Pharma. Almirall shall maintain records of all sales of Product and customers sufficient for Almirall or GW Pharma (as appropriate) to adequately administer a recall for the period required by Applicable Law.
Appears in 2 contracts
Sources: Asset Purchase and License Agreement, Asset Purchase and License Agreement
Forecasts Orders Delivery and Acceptance. 10.1 No later than six months prior to the anticipated Launch date for Product in the Territory and by the fifth day of each month thereafter, Almirall shall prepare and provide GW Pharma with a written forecast of its total requirement for Product (unlabelled anonymous vials) for at least the following eighteen (18) months (“Forecast”). Against the Product Forecast Almirall will formally call off the respective quantities in line with the Product Firm Order process described in Clause 10.3.
10.2 No later than six months prior to the anticipated Launch date for Presentation in each Territory and by the fifth day of each month thereafter, Almirall shall prepare and provide GW Pharma with a written forecast of its total requirements for Presentation (being finished Labelled and Packaged Product for country) for at least the following eighteen (18) months (“Forecast”). Against the Presentation Forecast Almirall will formally call off the respective quantities in line with the Presentation Firm Order process described in Clause 10.4.
10.3 The quantities of Products detailed in the first *** months of each Product Forecast (“Product Firm Order Period”) shall constitute a binding commitment on Almirall to purchase such quantities of Product from GW Pharma on the terms and conditions of this Agreement (“Product Firm Order”). With respect to the total requirement for Product, Almirall shall issue to GW Pharma by the fifth Business Day of each month a Product Firm Order for the quantity of Product (unlabelled anonymous vials) required in the fourth month of the Product Forecast. For the avoidance of doubt the first Product Firm Order will consist of a quantity of Product ordered for the *** month *** months ***. The Parties agree that all Firm Orders for the Products placed by Almirall under this Agreement shall be supplied on the terms of this Agreement. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
10.4 The quantities of Presentations detailed in the first month of each Presentation Forecast (“Presentation Firm Order Period”) shall constitute a binding commitment on Almirall to purchase such quantities of the Presentations from GW Pharma on the terms and conditions of this Agreement (“Presentation Firm Order”). With respect to the total requirement for Presentation, Almirall shall issue to GW Pharma by the tenth Business Day of each month a Presentation Firm Order for the quantity of Presentations (being finished Labelled and Packaged Product for country) required in the following month of that Presentation Forecast. The sum of the Presentation Firm Order quantities to be Labelled and Packaged shall be no greater than the total Product Firm Order for that month as described in Clause 10.3. The quantities to be Labelled, the ‘labelling plan’, will be documented and attached as part of the Presentation Firm Order.
10.5 In determining Product Firm Order quantities, Almirall shall take account of manufacturing batch sizes, such that Almirall must accept as fulfilled orders actual quantities of Products manufactured which are within a margin of *** percent (***%) of the Product Firm Order quantity. In the event GW Pharma manufactures Product quantities in an aggregated shortfall *** percent (***%), then GW Pharma shall be obliged to make up such shortfall quantities as early as possible. GW Pharma shall notify Almirall of the initial manufacturing batch size for the Products six (6) months in advance of anticipated Launch.
10.6 In determining Presentation Firm Order quantities and the labelling plan, Almirall shall take account of labelling batch sizes of *** (subject to GW Pharma confirmation), such that Almirall must accept as fulfilled orders actual quantities of labelled Presentations which are within a *** percent (***%) of the Presentation Firm Order quantity. In the event GW Pharma supplies quantities in an aggregated shortfall of *** percent (***%), then GW Pharma shall be obliged to make up such shortfall quantities as early as possible. GW Pharma shall notify Almirall of the minimum labelling batch size for the Presentations six months in advance of anticipated launch.
10.7 Almirall agrees to discuss (via conference call) with GW Pharma on a monthly basis, *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. no later than the 10th Business Day of the month, the latest Forecasts sent by Almirall, for each Territory. The purpose of this discussion is for Almirall to explain changes made to the Forecasts and to highlight any future developments in the Territory that may affect future Forecasts. GW Pharma will document the monthly demand management discussion and send a summary of the discussion to Almirall within 5 Business Days thereof. GW Pharma will also review whether the latest Forecasts raise any issues regarding GW Pharma’s ability to supply Product to meet anticipated future demand. If potential issues arise GW Pharma will respond to Almirall within thirty (30) days with an action plan responding to the issues.
10.8 In addition to the requirements of Clause 9.4.1 GW Pharma shall hold sufficient stocks of both CBD Botanical Drug Substance and THC Botanical Drug Substance to meet the Forecast requirements during the Product Firm Order Period and up to *** percent (***%) of the Product Forecast requirements detailed in the months ***. For clarity, this means that GW Pharma shall hold sufficient stocks of CBD Botanical Drug Substance and THC Botanical Drug Substance in bulk form to cover the Firm Order Period ***% of the demand for months *** but in any event shall hold stocks of CBD Botanical Drug Substance and THC Botanical Drug Substance in bulk form necessary to manufacture a volume of Product equal to or greater than the total volume of Almirall’s Firm Orders for the previous six (6) months. Both Parties shall conduct their businesses so as to minimise any stock write-offs.
10.9 GW Pharma shall hold, at GW Pharma’s cost, safety stocks of printed packaging components as agreed with Almirall. These safety stock targets shall be reviewed on a monthly basis, in the light of monthly Presentation Forecast, and any changes shall be documented as part of the demand management process described in Clause 10.7. Any write off of printed packaging materials is as agreed under Clause 14.4.1 and 14.4.2.
10.10 Almirall may ask GW Pharma for additional quantities to be manufactured and delivered by GW Pharma during the Firm Order Period. GW Pharma shall use its reasonable efforts to comply with Almirall’s additional demand. In any case GW Pharma shall give notice to Almirall within ten (10) Business Days of the receipt of the written order of its ability to meet such additional quantity. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
10.11 It is understood that volumes detailed in each Forecast for the months following the Firm Order Period constitute a good faith estimate of future requirement of Product by Almirall, its Affiliates and distributors and do not comprise a minimum purchase requirement or a binding commitment on Almirall. Almirall recognises that GW Pharma will commit to resources and materials against the Forecast and that these decisions rely on GW Pharma understanding the future demands using the process described in Clause 10.4.
10.12 GW Pharma shall respond to each Firm Order received from Almirall within three (3) Business Days of receipt. The response shall include confirmation of the quantity set out in the Firm Order and the date by which GW Pharma will be able to deliver the Product. In the event that discussion is required regarding the timing of delivery then the relevant personnel from both Parties will negotiate in good faith and agree and confirm in writing an amended Firm Order within four (4) Business Days of receipt by GW Pharma of the original Firm Purchase Order except during the period 20th December to 6th January in each Year when the periods of three (3) or four (4) Business Days referred to herein shall be replaced by eight (8) Business Days in each case.
10.13 All Product supplied under this Agreement shall be delivered FCA (Incoterms 2000) *** premises located in *** and shall be accompanied by a written Certificate of Analysis and Release confirming that such quantity of Product meets the Specification, a Packing-list and an insurance policy. GW Pharma shall secure transport and insurance, from Wockhardt to Sant Andreu de la Barca (Barcelona) or its nominee’s facility in Europe, with its own providers at Almirall’s cost and expense. Almirall shall pay all freight, insurance charges, taxes, import and export duties, inspection fees and other charges applicable to the sale and transport of Product purchased by Almirall hereunder which amounts shall be separately set forth on GW Pharma’s invoices to Almirall. Title and risk of loss and damage to Product purchased by Almirall hereunder shall pass to Almirall upon collection of the Product by the Third Party carrier.
10.14 Almirall has the right, at anytime and in an order-by-order basis, to secure transport or insurance with its own Almirall providers, by communicating such decision to GW *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Pharma in the correspondent Presentation Firm order.
10.15 Following receipt of a shipment of Product from GW Pharma, Almirall or its designated agent shall, within five (5) days, carry out a visual inspection (as defined below) of such shipment to ensure that Packaging and Labelling of Product has taken place in accordance with the Specification and is accompanied by an associated Certificate of Analysis and if Almirall determines in its sole discretion (exercised reasonably) that it has not so taken place it shall promptly notify rejection of shipment to GW Pharma in writing. Subject to the provisions of Clause 10.16, if Almirall does not notify GW Pharma of rejection of such shipment within such five (5) days, such shipment of Product shall be deemed to have been accepted.
10.16 For the purposes of this Agreement, “visual inspection” shall mean:
10.16.1 comparing the applicable order against the documentation accompanying the shipment to verify that the delivery date, identity, quantity and exterior shipment labelling comply with the order;
10.16.2 verifying that the Certificate of Analysis for the shipment states that the Product conforms in all material respects to the applicable Specifications;
10.16.3 visually inspecting the exterior of the shipment of Products to verify that the shipment appears to be in good condition; and
10.16.4 verifying that the temperature of the shipment has remained within specification by reviewing the data logger information. For the avoidance of doubt, visual inspection does not include laboratory analysis.
10.17 Notwithstanding the foregoing, GW Pharma shall remain liable to Almirall to the extent provided in Clause 10.19 or 10.20 as appropriate for any latent defect that subsequently is discovered which renders the Product unsaleable, if such defect is due to the failure of Product to meet Specification and/or GMP and provided that Almirall immediately inform GW Pharma by notice in writing of such defect and rejection of the relevant shipment not later than ten (10) Business Days from the date of discovery of such latent defect.
10.18 Within 10 days of receipt by GW Pharma of a notice of rejection from Almirall in accordance with Clauses 10.15 or 10.17 GW Pharma shall indicate in writing to Almirall whether GW Pharma is issuing a return authorisation or not. In the event that a return authorisation is so issued Almirall shall return to GW Pharma at GW Pharma’s expense the quantities of Product in question and GW Pharma shall replace such quantities within twenty (20) Business Days or as soon as reasonably practicable thereafter. If the payment in respect of such quantities is outstanding, it shall be postponed until such replacement quantities are received and accepted by Almirall in accordance with this Clause 10.
10.19 After receipt of any rejection notice from Almirall pursuant to Clause 10.15 or Clause 10.17 if GW Pharma does not issue a return authorisation under Clause 10.17 GW Pharma shall analyse any batch of Product rejected by Almirall for non-conformity with the Specifications within twenty (20) Business Days of receipt of such notice, and present its findings with respect to such Product to Almirall. If such tests confirm non-conformity with the Specification GW Pharma shall promptly supply to Almirall (at GW Pharma’s cost and expense) a conforming batch in the same quantity as the rejected batch and shall reimburse Almirall for any out of pocket costs or expenses incurred by Almirall including shipping charges in relation to such non-conforming batch. If the Parties cannot agree on whether the batch of Product in question conforms to the Specifications, an independent qualified laboratory reasonably acceptable to both Parties, and at a cost equally shared by both Parties, shall analyse both Almirall’s and GW Pharma’s samples of Product in question, and the definitive results of such laboratory shall be binding on the Parties. If the batch of Product in question is determined to be non-conforming, such non-conforming Product shall be held for GW Pharma’s disposition, or shall be returned to GW Pharma, in each case at GW Pharma’s expense, as directed by GW Pharma no later than ten (10) Business Days following such determination. GW Pharma shall replace each non-conforming batch of Product, or the non-conforming portion thereof, with conforming Product within twenty (20) Business Days or as soon as reasonably practical after receipt of notice of rejection thereof. If the batch of Product in question is determined to be conforming and provided that the Certificate of Analysis did not indicate it to be non-conforming, such Product shall be returned to Almirall at Almirall’s cost and expense.
10.20 GW Pharma shall employ stock rotation methods and techniques consistent with Good Industry Practice so as to ensure that Product delivered to Almirall has a minimum of seventy-five per cent (75%) of its shelf life unexpired, provided the approved shelf-life is at least of sixteen (16) months. Almirall has the right to reject any Product with less than *** months of remaining shelf-life and save as otherwise agreed between the parties pursuant to Clause 9.5.
10.21 The Parties agree that the costs of recall shall be met as follows: if a recall arises due to any act or omission by Almirall the Cost of Manufacture, distribution expenses and third-party recall expenses (collectively, the “Recall Costs”) shall be borne by Almirall; if a recall arises from any other reason then the Recall Costs shall be borne by GW Pharma. Almirall shall maintain records of all sales of Product and customers sufficient for Almirall or GW Pharma (as appropriate) to adequately administer a recall for the period required by Applicable Law.
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Sources: Product Commercialisation and Supply Agreement (Gw Pharmaceuticals PLC)