Common use of Forecasts and Orders Clause in Contracts

Forecasts and Orders. 2.3.1 Not less than twelve (12) months prior to its first purchase of Ingredient for use in the manufacture of Products to be sold to Third Parties, Wyeth-Ayerst shall provide GalaGen with a written forecast (by Calendar Quarter) of the quantity of Ingredient that Wyeth-Ayerst desires to have delivered to it during the first twelve (12) month period of Product sales. Within six (6) months prior to its first purchase of Ingredient, Wyeth-Ayerst shall provide GalaGen with an updated forecast for the first twelve (12) month period (by Calendar Quarter), and by the beginning of such twelve (12) month period shall provide GalaGen with an updated forecast for the last three (3) Calendar Quarters of such twelve (12) month period and for the Calendar Quarter following immediately thereafter. Thereafter, at least ninety (90) days before the end of each subsequent Calendar Quarter, Wyeth-Ayerst shall provide a written updated forecast (by Calendar Quarter) in accordance with the provisions of Section 2.3.2 hereof. 2.3.2 Each successive forecast shall update the forecast previously given for the last three (3) Calendar Quarters covered and add a forecast for the Calendar Quarter following immediately thereafter, to enable GalaGen to have sufficient information to schedule its or its sub-contractors' manufacturing operations to meet Wyeth-Ayerst's forecasted requirements of the Ingredient. GalaGen acknowledges that such forecasts are only estimates of Wyeth-Ayerst's purchase requirements of the Ingredient and that Wyeth-Ayerst shall not be bound by any such estimate, except that after Regulatory Approval the first Calendar Quarter of each successive forecast so provided shall represent a binding commitment of Wyeth-Ayerst to purchase and of GalaGen to supply such forecasted quantity of Ingredient in a timely manner, subject to adjustment within the limits set forth in Section 2.3.4 hereof. 2.3.3 Wyeth-Ayerst shall order and maintain reasonable inventories of the Ingredient, having due regard to its current and forecasted sales volumes for the Products. Wyeth-Ayerst shall issue to GalaGen firm purchase orders for each delivery not later than two (2) months prior to the requested delivery date. Such purchase orders shall specify the quantity of Ingredient desired, and the place(s) to which and the manner and dates by which delivery is to be made. To the extent the terms of any purchase order or acknowledgment thereof are inconsistent with the terms of this Agreement, the terms of this Agreement shall control. 2.3.4 The quantity of Ingredient ordered by Wyeth-Ayerst in any Calendar Quarter shall not be less than seventy-five percent (75%) of the quantity specified in the last binding forecast provided by Wyeth-Ayerst for such Calendar Quarter. Additionally, GalaGen shall not be obligated to supply that quantity of Ingredient in any Calendar Quarter that is more than one hundred and twenty-five percent (125%) of the last binding forecast provided by Wyeth-Ayerst for the Calendar Quarter in question; PROVIDED, HOWEVER, that GalaGen shall endeavor to take all reasonable steps to fill purchase orders for the Ingredient in excess of such amount. 2.3.5 All estimates shall be prepared in good faith in order to facilitate GalaGen's efficient manufacture and shipment of the Ingredient in compliance with this Agreement, and except as set forth in Section 2.3.2 will not be binding upon Wyeth-Ayerst or GalaGen in any way and Wyeth-Ayerst shall not be responsible for any loss or expense of GalaGen's arising from the forecast. 2.3.6 Notwithstanding any other provision of this Agreement, GalaGen in no event shall be obligated to supply Wyeth-Ayerst with an amount of Ingredient that exceeds seventy percent (70%) of GalaGen's total capacity for the manufacture of Ingredient and all other products. In the event Wyeth-Ayerst provides GalaGen with good faith forecasts that exceed such capacity, GalaGen agrees that it will use its Commercially Reasonable Efforts to seek and employ subcontractors, as permitted under Section 2.1 hereof, to manufacture such excess amounts of Ingredient on commercially reasonable terms.

Forecasts and Orders. 2.3.1 Not less than twelve At least seven (12) months prior to its first purchase of Ingredient for use in the manufacture of Products to be sold to Third Parties, Wyeth-Ayerst shall provide GalaGen with a written forecast (by Calendar Quarter) of the quantity of Ingredient that Wyeth-Ayerst desires to have delivered to it during the first twelve (12) month period of Product sales. Within six (6) months prior to its first purchase of Ingredient, Wyeth-Ayerst shall provide GalaGen with an updated forecast for the first twelve (12) month period (by Calendar Quarter), and by the beginning of such twelve (12) month period shall provide GalaGen with an updated forecast for the last three (3) Calendar Quarters of such twelve (12) month period and for the Calendar Quarter following immediately thereafter. Thereafter, at least ninety (90) days before the end of each subsequent Calendar Quarter, Wyeth-Ayerst shall provide a written updated forecast (by Calendar Quarter) in accordance with the provisions of Section 2.3.2 hereof. 2.3.2 Each successive forecast shall update the forecast previously given for the last three (3) Calendar Quarters covered and add a forecast for the Calendar Quarter following immediately thereafter, to enable GalaGen to have sufficient information to schedule its or its sub-contractors' manufacturing operations to meet Wyeth-Ayerst's forecasted requirements of the Ingredient. GalaGen acknowledges that such forecasts are only estimates of Wyeth-Ayerst's purchase requirements of the Ingredient and that Wyeth-Ayerst shall not be bound by any such estimate, except that after Regulatory Approval the first Calendar Quarter of each successive forecast so provided shall represent a binding commitment of Wyeth-Ayerst to purchase and of GalaGen to supply such forecasted quantity of Ingredient in a timely manner, subject to adjustment within the limits set forth in Section 2.3.4 hereof. 2.3.3 Wyeth-Ayerst shall order and maintain reasonable inventories of the Ingredient, having due regard to its current and forecasted sales volumes for the Products. Wyeth-Ayerst shall issue to GalaGen firm purchase orders for each delivery not later than two (27) months prior to the requested delivery dateexpected receipt of a Regulatory Approval with respect to a Product in a Territory, Alvogen shall provide to Alvotech a twenty-four (24) month forecast of its requirements for such Product (each such forecast, an “Initial Forecast”). Such purchase orders shall specify Thereafter, Alvogen shall, on a monthly basis, provide to Alvotech a twenty-four (24) month rolling forecast of its anticipated requirements for each Product, and, beginning on the six (6) month anniversary of the Exercise Notice Delivery Date, the quantity of Ingredient desiredsuch Product, if any, that a Designated Manufacturer shall manufacture pursuant to Article VIII (the “Rolling Forecast” and, together with the Initial Forecast, the “Forecasts”). As used herein, the term “Short-Term Forecast” means the first seven (7) calendar months of the most recent Forecast, the term “Fixed Requirements Month” means the first, second or third calendar month set forth in a Short-Term Forecast, the term “Variable Requirements Month” means the fourth, fifth, sixth or seventh calendar month set forth in a Short-Term Forecast, and the place(s) term “Anticipated Monthly Product Requirements” means, with respect to a given Product, the amounts set forth in the Short-Term Forecast with respect to such Product for a given calendar month. The Forecasts shall represent reasonable estimates for planning purposes only, which and the manner and dates by which delivery is Alvogen shall be entitled to be made. To the extent the terms of any purchase order or acknowledgment thereof are inconsistent with revise in future Forecasts, subject to the terms of this Agreement, Section 7.1. Alvogen may adjust the terms of this Agreement shall control. 2.3.4 The quantity of Ingredient ordered by WyethAnticipated Monthly Product Requirements with respect to a given Product for each Variable Requirements Month set forth in each Short-Ayerst in any Calendar Quarter shall Term Forecast to an amount not to exceed one hundred twenty-five percent (125%) or to be less than seventy-five percent (75%) of the quantity specified Anticipated Monthly Product Requirements for such Product set forth in the last binding forecast provided by WyethShort-Ayerst Term Forecast the first time that such calendar month became a Variable Requirements Month. Alvogen may not change the Anticipated Monthly Product Requirements for a calendar month once such Calendar Quartercalendar month becomes a Fixed Requirements Month. AdditionallySubject to the terms of this Section 7.1, GalaGen Alvogen shall not be obligated to supply that quantity of Ingredient in any Calendar Quarter that is more than purchase one hundred and twenty-five percent (125100%) of the last binding forecast provided by Wyeth-Ayerst Anticipated Monthly Product Requirements for the Calendar Quarter in question; PROVIDED, HOWEVER, that GalaGen shall endeavor to take all reasonable steps to fill purchase orders for the Ingredient in excess of such amount. 2.3.5 All estimates shall be prepared in good faith in order to facilitate GalaGen's efficient manufacture and shipment of the Ingredient in compliance with this Agreement, and except as each Fixed Requirements Month set forth in Section 2.3.2 will not each Short-Term Forecast less the amount, if any, of the Anticipated Monthly Product Requirements to be binding upon Wyeth-Ayerst or GalaGen manufactured by a Designated Manufacturer in any way and Wyeth-Ayerst shall not be responsible for any loss or expense of GalaGen's arising from accordance with Article VIII (the forecast“Obligated Purchases”). 2.3.6 Notwithstanding any other provision of this Agreement, GalaGen in no event shall be obligated to supply Wyeth-Ayerst with an amount of Ingredient that exceeds seventy percent (70%) of GalaGen's total capacity for the manufacture of Ingredient and all other products. In the event Wyeth-Ayerst provides GalaGen with good faith forecasts that exceed such capacity, GalaGen agrees that it will use its Commercially Reasonable Efforts to seek and employ subcontractors, as permitted under Section 2.1 hereof, to manufacture such excess amounts of Ingredient on commercially reasonable terms.

Forecasts and Orders. 2.3.1 Not later than six months after submission of the NDA for a Product or other applicable regulatory filing on a country-by-country basis, GKI will provide ABI with a 12 month forecast of GKI's requirement of each Product, which forecast will include designation of whether such Product shall be provided in bulk or Unit form, for which 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 twelve (12) months 45 days prior to its 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 purchase two quarters of Ingredient for use the 12 month forecast will be stated in monthly requirements. The second two quarters of the 12 month forecast 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 manufacture of Products to be sold to Third Parties, Wyeth-Ayerst shall provide GalaGen with a written previous forecast (by Calendar Quarter) of the quantity of Ingredient that Wyeth-Ayerst desires to have delivered to it during the first twelve (12) for such three month period of Product salesshall not exceed 50% in aggregate during that three month period. Within six (6) months prior to its first purchase of IngredientFor example, Wyeth-Ayerst shall provide GalaGen with an updated if GKI's forecast for the first twelve (12) three months was for 100 Units and its forecast for the second three months was for 200 Units, the maximum number of Units GKI could order at the time the second three month period becomes fixed would be 300 Units (by Calendar Quarteri.e., 50% of 200 Units plus the 200 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, and by GKI will provide to ABI a rolling 12 month forecast for 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 such twelve (12) month period shall provide GalaGen with an updated forecast each month. All orders will be for the last three (3) Calendar Quarters of such twelve (12) month period and for the Calendar Quarter following immediately thereafterfull batch quantities. Thereafter, at least ninety (90) days before the end of each subsequent Calendar Quarter, Wyeth-Ayerst shall provide a written updated forecast (by Calendar Quarter) It is understood that ABI will not maintain Product inventory in accordance with the provisions of Section 2.3.2 hereof. 2.3.2 Each successive forecast shall update the forecast previously given for the last three (3) Calendar Quarters covered and add a forecast for the Calendar Quarter following immediately thereafter, to enable GalaGen to have sufficient information to schedule its or its sub-contractors' manufacturing operations to meet Wyeth-Ayerst's forecasted requirements excess of the Ingredientapplicable forecast, but will produce Product upon receipt of that portion of GKI's forecasts that constitute firm orders to purchase. GalaGen acknowledges that such forecasts are only estimates of Wyeth-Ayerst's purchase requirements of the Ingredient and that Wyeth-Ayerst shall not be bound by any such estimate, except that after Regulatory Approval the first Calendar Quarter of each successive forecast so provided shall represent a binding commitment of Wyeth-Ayerst to purchase and of GalaGen to supply such forecasted quantity of Ingredient Nothing in a timely manner, subject to adjustment within the limits set forth in Section 2.3.4 hereof. 2.3.3 Wyeth-Ayerst shall order and maintain reasonable inventories of the Ingredient, having due regard to its current and forecasted sales volumes for the Products. Wyeth-Ayerst shall issue to GalaGen firm purchase orders for each delivery not later than two (2) months prior to the requested delivery date. Such purchase orders shall specify the quantity of Ingredient desired, and the place(s) to which and the manner and dates by which delivery is to be made. To the extent the terms of any purchase order or acknowledgment thereof are inconsistent with the terms of this Agreement, the terms of this Agreement shall control. 2.3.4 The quantity obligate ABI to deliver Product if HBL is unable for any reason to provide Product. GKI agrees to purchase a sufficient amount of Ingredient ordered by WyethProduct to enable GKI to carry sufficient inventory to allow for fluctuations in sales demand so as to allow ABI reasonable lead-Ayerst time to meet increased demand. ABI will use commercially reasonable efforts to meet any increase in any Calendar Quarter shall not be less than seventy-five percent (75%) demand in excess of the quantity specified in the last binding forecast provided by Wyeth-Ayerst for such Calendar Quarter. Additionallyallowed adjustment, GalaGen shall but will not be obligated to supply that quantity of Ingredient in any Calendar Quarter that is more than one hundred and twenty-five percent (125%) of the last binding forecast provided do so. All forecasts will be made by Wyeth-Ayerst for the Calendar Quarter in question; PROVIDED, HOWEVER, that GalaGen shall endeavor GKI to take all reasonable steps to fill purchase orders for the Ingredient in excess of such amount. 2.3.5 All estimates shall be prepared ABI in good faith based upon standard commercial parameters. From time to time after the Effective Date, the Parties shall consider whether, in order light of market demand, manufacturing capacity, inventory levels and other pertinent factors, to facilitate GalaGen's efficient manufacture and shipment 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 Ingredient in compliance text has been omitted and filed separately with this Agreement, and except as set forth in Section 2.3.2 will not be binding upon Wyeth-Ayerst or GalaGen in any way and Wyeth-Ayerst shall not be responsible for any loss or expense of GalaGen's arising from the forecast. 2.3.6 Notwithstanding any other provision of this Agreement, GalaGen in no event shall be obligated to supply Wyeth-Ayerst with an amount of Ingredient that exceeds seventy percent (70%) of GalaGen's total capacity for the manufacture of Ingredient and all other productsCommission. In the event Wyeth-Ayerst provides GalaGen with good faith forecasts that exceed such capacity, GalaGen agrees that it will use its Commercially Reasonable Efforts to seek and employ subcontractors, as permitted under Section 2.1 hereof, to manufacture such excess amounts of Ingredient on commercially reasonable terms.24

Forecasts and Orders. 2.3.1 (a) Not later than six months following submission of the NDA for a Product or other applicable regulatory filing on a country-by-country basis, Atrix will provide ABI with a 12 month forecast of Atrix's requirement of each Product, which forecast will include designation of whether such Product shall be provided in bulk or Unit form, for which an NDA, or other applicable regulatory filing, has been submitted, on a Product-by-Product basis, as follows: (i) During the period commencing six months 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 twelve (12) months 45 days prior to its 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 purchase two quarters of Ingredient for use the 12 month forecast will be stated in monthly requirements. The second two quarters of the 12 month forecast 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 **** 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 manufacture of Products to be sold to Third Parties, Wyeth-Ayerst shall provide GalaGen with a written previous forecast (by Calendar Quarter) of the quantity of Ingredient that Wyeth-Ayerst desires to have delivered to it during the first twelve (12) for such three month period of Product salesshall not exceed 50% in aggregate during that three month period. Within six (6) months prior to its first purchase of IngredientFor example, Wyeth-Ayerst shall provide GalaGen with an updated if Atrix's forecast for the first twelve (12) three months was for 100 Units and its forecast for the second three months was for 200 Units, the maximum number of Units Atrix could order at the time the second three month period becomes fixed would be 300 Units (by Calendar Quarteri.e., 50% of 200 Units plus the 200 Units originally forecast). The last two quarters of any 12 month forecast will be an estimate and not binding. (ii) Following the end of the fourth full calendar quarter following the First Commercial Sale of a Product, and by Atrix will provide to ABI a rolling 12 month forecast for 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 such twelve (12) month period shall provide GalaGen with an updated forecast each month. All orders will be for the last three (3) Calendar Quarters of such twelve (12) month period and for the Calendar Quarter following immediately thereafter. Thereafter, at least ninety (90) days before the end of each subsequent Calendar Quarter, Wyeth-Ayerst shall provide a written updated forecast (by Calendar Quarter) in accordance with the provisions of Section 2.3.2 hereoffull batch quantities. 2.3.2 Each successive forecast shall update the forecast previously given for the last three (3b) Calendar Quarters covered and add a forecast for the Calendar Quarter following immediately thereafter, to enable GalaGen to have sufficient information to schedule its or its sub-contractors' manufacturing operations to meet Wyeth-Ayerst's forecasted requirements of the Ingredient. GalaGen acknowledges It is understood that such forecasts are only estimates of Wyeth-Ayerst's purchase requirements of the Ingredient and that Wyeth-Ayerst shall ABI will not be bound by any such estimate, except that after Regulatory Approval the first Calendar Quarter of each successive forecast so provided shall represent a binding commitment of Wyeth-Ayerst to purchase and of GalaGen to supply such forecasted quantity of Ingredient in a timely manner, subject to adjustment within the limits set forth in Section 2.3.4 hereof. 2.3.3 Wyeth-Ayerst shall order and maintain reasonable inventories of the Ingredient, having due regard to its current and forecasted sales volumes for the Products. Wyeth-Ayerst shall issue to GalaGen firm purchase orders for each delivery not later than two (2) months prior to the requested delivery date. Such purchase orders shall specify the quantity of Ingredient desired, and the place(s) to which and the manner and dates by which delivery is to be made. To the extent the terms of any purchase order or acknowledgment thereof are inconsistent with the terms of this Agreement, the terms of this Agreement shall control. 2.3.4 The quantity of Ingredient ordered by Wyeth-Ayerst in any Calendar Quarter shall not be less than seventy-five percent (75%) of the quantity specified in the last binding forecast provided by Wyeth-Ayerst for such Calendar Quarter. Additionally, GalaGen shall not be obligated to supply that quantity of Ingredient in any Calendar Quarter that is more than one hundred and twenty-five percent (125%) of the last binding forecast provided by Wyeth-Ayerst for the Calendar Quarter in question; PROVIDED, HOWEVER, that GalaGen shall endeavor to take all reasonable steps to fill purchase orders for the Ingredient Product inventory in excess of such amount. 2.3.5 All estimates shall be prepared in good faith in order to facilitate GalaGenthe applicable forecast, but will produce Product upon receipt of that portion of Atrix's efficient manufacture and shipment of the Ingredient in compliance with this Agreement, and except as set forth in Section 2.3.2 will not be binding upon Wyeth-Ayerst or GalaGen in any way and Wyeth-Ayerst shall not be responsible for any loss or expense of GalaGen's arising from the forecast. 2.3.6 Notwithstanding any other provision of this Agreement, GalaGen in no event shall be obligated to supply Wyeth-Ayerst with an amount of Ingredient that exceeds seventy percent (70%) of GalaGen's total capacity for the manufacture of Ingredient and all other products. In the event Wyeth-Ayerst provides GalaGen with good faith forecasts that exceed such capacity, GalaGen agrees that it will use its Commercially Reasonable Efforts constitute firm orders to seek and employ subcontractors, as permitted under Section 2.1 hereof, to manufacture such excess amounts of Ingredient on commercially reasonable termspurchase.

Forecasts and Orders. 2.3.1 Not less 4.1 In order to permit Elan to allocate its manufacturing capacity and to assist Buyer with its sales and marketing, Buyer shall provide Elan with bona fide written forecasts of its requirements for each of the Products as follows: 4.1.1 By thirty (30) days after the Effective Date, and thereafter each calendar month not later than twelve the 23rd of the month, an 18-month forecast (12) months prior to its first purchase commencing at the beginning of Ingredient for use the following month), broken down by month (each, a “Monthly Forecast Report”); and 4.1.2 not later than 1 July in the manufacture each year, a two-year forecast, broken down by year. 4.2 The aggregate amount of Products forecasted to be sold to Third Parties, Wyeth-Ayerst shall provide GalaGen with a written forecast (by Calendar Quarter) of the quantity of Ingredient that Wyeth-Ayerst desires to have delivered to it during required in the first twelve (12) month period months of Product sales. Within six each Monthly Forecast Report shall, unless otherwise agreed by Elan, not increase or decrease by more than twenty-five percent (625%) months prior as compared to its first purchase of Ingredient, Wyeth-Ayerst shall provide GalaGen with an updated forecast for the first twelve (12) month period (by Calendar Quarter), and by the beginning months of such twelve (12) month period shall provide GalaGen with an updated forecast for the last three (3) Calendar Quarters of such twelve (12) month period and for the Calendar Quarter following immediately thereafter. Thereafter, at least ninety (90) days before the end of each subsequent Calendar Quarter, Wyeth-Ayerst shall provide a written updated forecast (by Calendar Quarter) in accordance with the provisions of Section 2.3.2 hereof. 2.3.2 Each successive forecast shall update the forecast previously given for the last three (3) Calendar Quarters covered and add months prior; provided, however, that until there exists a forecast for the Calendar Quarter following immediately thereafter, to enable GalaGen to have sufficient information to schedule its or its sub-contractors' manufacturing operations to meet Wyeth-Ayerst's forecasted requirements of the Ingredient. GalaGen acknowledges that such forecasts are only estimates of Wyeth-Ayerst's purchase requirements of the Ingredient and that Wyeth-Ayerst shall not be bound by any such estimate, except that after Regulatory Approval the first Calendar Quarter of each successive forecast so provided shall represent a binding commitment of Wyeth-Ayerst to purchase and of GalaGen to supply such forecasted quantity of Ingredient in a timely manner, subject to adjustment within the limits set forth in Section 2.3.4 hereof. 2.3.3 Wyeth-Ayerst shall order and maintain reasonable inventories of the Ingredient, having due regard to its current and forecasted sales volumes for the Products. Wyeth-Ayerst shall issue to GalaGen firm purchase orders for each delivery not later than two (2) Monthly Forecast Report from three months prior to the requested delivery date. Such purchase orders shall specify the quantity of Ingredient desired, and the place(s) to which and the manner and dates by which delivery is to be made. To the extent the terms of any purchase order or acknowledgment thereof are inconsistent with the terms of this Agreementthen-current Monthly Forecast Report, the terms initial Monthly Forecast Report shall be used for purposes of this Agreement shall controlsuch comparison. 2.3.4 The quantity of Ingredient ordered by Wyeth-Ayerst in any Calendar Quarter 4.3 Buyer shall not be less than seventy-five bound to order one hundred percent (75100%) of the quantity specified forecast required quantities of the Products in each respective month of the last binding forecast provided by Wyeth-Ayerst period of five (5) months immediately following each Monthly Forecast Report, but otherwise forecasts shall not be binding. With respect to such orders, Buyer shall submit to Elan a written purchase order for such Calendar Quarterrequired quantities of Products, specifying the order quantity and the date on which delivery of the order is required (the “Specified Delivery Date,” which shall in no event be earlier than one hundred fifty (150) days after the date of Elan’s receipt of such written purchase order). AdditionallyFor the avoidance of doubt, GalaGen the parties acknowledge and agree that, notwithstanding anything to the contrary contained in this Agreement, other than pursuant to the preceding two sentences Buyer shall not be obligated to place any minimum number of orders under this Agreement. 4.4 Elan shall not be obligated to supply that quantity of Ingredient in any Calendar Quarter that is more than one hundred and twenty-five percent (125%) of the last binding forecast provided by Wyeth-Ayerst for the Calendar Quarter in question; PROVIDED, HOWEVER, that GalaGen shall endeavor to take all reasonable steps to fill purchase orders for the Ingredient Products in excess of such amountBuyer’s requirements as forecast in accordance Clauses 4.1, 4.2 and 4.3. 2.3.5 All estimates shall be prepared in good faith in order to facilitate GalaGen's efficient manufacture 4.5 Notwithstanding Clauses 4.1, 4.2, 4.3 and shipment of the Ingredient in compliance with this Agreement4.4, and except as set forth in Section 2.3.2 will not be binding upon Wyeth-Ayerst or GalaGen in any way and Wyeth-Ayerst shall not be responsible for any loss or expense of GalaGen's arising from the forecast. 2.3.6 Notwithstanding any other provision of this Agreement, GalaGen in no event shall be obligated to supply Wyeth-Ayerst with an amount of Ingredient that exceeds seventy percent (70%) of GalaGen's total capacity for the manufacture of Ingredient and all other products. In the event Wyeth-Ayerst provides GalaGen with good faith forecasts that exceed such capacity, GalaGen agrees that it Elan will use its Commercially Reasonable Efforts to seek and employ subcontractors, as permitted under Section 2.1 hereof, to manufacture such excess amounts of Ingredient on commercially reasonable termsefforts to fulfill Buyer’s requirements in excess of forecasted amounts. 4.6 The order quantity shall be in whole number multiples of the minimum batch size of the Products, which minimum batch size shall be as set out in Schedule 1; Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.

Forecasts and Orders. 2.3.1 Not less 4.1 In order to permit Elan to allocate its manufacturing capacity and to assist Buyer with its sales and marketing, Buyer shall provide Elan with bona fide written forecasts of its requirements for each of the Products as follows: 4.1.1 By thirty (30) days after the Effective Date, and thereafter each calendar month not later than twelve the 23rd of the month, an 18-month forecast (12) months prior to its first purchase commencing at the beginning of Ingredient for use the following month), broken down by month (each, a “Monthly Forecast Report”); and 4.1.2 not later than 1 July in the manufacture each year, a two-year forecast, broken down by year. 4.2 The aggregate amount of Products forecasted to be sold to Third Parties, Wyeth-Ayerst shall provide GalaGen with a written forecast (by Calendar Quarter) of the quantity of Ingredient that Wyeth-Ayerst desires to have delivered to it during required in the first twelve (12) month period months of Product sales. Within six each Monthly Forecast Report shall, unless otherwise agreed by Elan, not increase or decrease by more than twenty-five percent (625%) months prior as compared to its first purchase of Ingredient, Wyeth-Ayerst shall provide GalaGen with an updated forecast for the first twelve (12) month period (by Calendar Quarter), and by the beginning months of such twelve (12) month period shall provide GalaGen with an updated forecast for the last three (3) Calendar Quarters of such twelve (12) month period and for the Calendar Quarter following immediately thereafter. Thereafter, at least ninety (90) days before the end of each subsequent Calendar Quarter, Wyeth-Ayerst shall provide a written updated forecast (by Calendar Quarter) in accordance with the provisions of Section 2.3.2 hereof. 2.3.2 Each successive forecast shall update the forecast previously given for the last three (3) Calendar Quarters covered and add months prior; provided, however, that until there exists a forecast for the Calendar Quarter following immediately thereafter, to enable GalaGen to have sufficient information to schedule its or its sub-contractors' manufacturing operations to meet Wyeth-Ayerst's forecasted requirements of the Ingredient. GalaGen acknowledges that such forecasts are only estimates of Wyeth-Ayerst's purchase requirements of the Ingredient and that Wyeth-Ayerst shall not be bound by any such estimate, except that after Regulatory Approval the first Calendar Quarter of each successive forecast so provided shall represent a binding commitment of Wyeth-Ayerst to purchase and of GalaGen to supply such forecasted quantity of Ingredient in a timely manner, subject to adjustment within the limits set forth in Section 2.3.4 hereof. 2.3.3 Wyeth-Ayerst shall order and maintain reasonable inventories of the Ingredient, having due regard to its current and forecasted sales volumes for the Products. Wyeth-Ayerst shall issue to GalaGen firm purchase orders for each delivery not later than two (2) Monthly Forecast Report from three months prior to the requested delivery date. Such purchase orders shall specify the quantity of Ingredient desired, and the place(s) to which and the manner and dates by which delivery is to be made. To the extent the terms of any purchase order or acknowledgment thereof are inconsistent with the terms of this Agreementthen-current Monthly Forecast Report, the terms initial Monthly Forecast Report shall be used for purposes of this Agreement shall controlsuch comparison. 2.3.4 The quantity of Ingredient ordered by Wyeth-Ayerst in any Calendar Quarter 4.3 Buyer shall not be less than seventy-five bound to order one hundred percent (75100%) of the quantity specified forecast required quantities of the Products in each respective month of the last binding forecast provided by Wyeth-Ayerst period of five (5) months immediately following each Monthly Forecast Report, but otherwise forecasts shall not be binding. With respect to such orders, Buyer shall submit to Elan a written purchase order for such Calendar Quarterrequired quantities of Products, specifying the order quantity and the date on which delivery of the order is required (the “Specified Delivery Date,” which shall in no event be earlier than one hundred fifty (150) days after the date of Elan’s receipt of such written purchase order). AdditionallyFor the avoidance of doubt, GalaGen the parties acknowledge and agree that, notwithstanding anything to the contrary contained in this Agreement, other than pursuant to the preceding two sentences Buyer shall not be obligated to place any minimum number of orders under this Agreement. 4.4 Elan shall not be obligated to supply that quantity of Ingredient in any Calendar Quarter that is more than one hundred and twenty-five percent (125%) of the last binding forecast provided by Wyeth-Ayerst for the Calendar Quarter in question; PROVIDED, HOWEVER, that GalaGen shall endeavor to take all reasonable steps to fill purchase orders for the Ingredient Products in excess of such amountBuyer’s requirements as forecast in accordance Clauses 4.1, 4.2 and 4.3. 2.3.5 All estimates shall be prepared in good faith in order to facilitate GalaGen's efficient manufacture 4.5 Notwithstanding Clauses 4.1, 4.2, 4.3 and shipment of the Ingredient in compliance with this Agreement4.4, and except as set forth in Section 2.3.2 will not be binding upon Wyeth-Ayerst or GalaGen in any way and Wyeth-Ayerst shall not be responsible for any loss or expense of GalaGen's arising from the forecast. 2.3.6 Notwithstanding any other provision of this Agreement, GalaGen in no event shall be obligated to supply Wyeth-Ayerst with an amount of Ingredient that exceeds seventy percent (70%) of GalaGen's total capacity for the manufacture of Ingredient and all other products. In the event Wyeth-Ayerst provides GalaGen with good faith forecasts that exceed such capacity, GalaGen agrees that it Elan will use its Commercially Reasonable Efforts to seek and employ subcontractors, as permitted under Section 2.1 hereof, to manufacture such excess amounts of Ingredient on commercially reasonable termsefforts to fulfill Buyer’s requirements in excess of forecasted amounts. 4.6 The order quantity shall be in whole number multiples of the minimum batch size of the Products, which minimum batch size shall be as set out in Schedule 1;

Forecasts and Orders. 2.3.1 Not less than twelve (12) months prior to its first purchase A. Upon the execution of Ingredient for use in the manufacture of Products to be sold to Third Partiesthis Agreement, Wyeth-Ayerst BTL shall provide GalaGen HNS with a written forecast (by Calendar Quarter) of the quantity of Ingredient that Wyeth-Ayerst desires to have delivered to it during the first twelve (12) month period written forecast of Product sales. Within six (6) months prior to DSS Equipment estimating its first purchase of Ingredient, Wyeth-Ayerst shall provide GalaGen with an updated forecast orders hereunder for deliveries commencing in the first calendar month following the month in which the parties have agreed in writing that the prototype of the Commercial System is in full compliance with this Agreement, as contemplated by Section 4.B hereof. Thereafter, on or before the last business day of each month during the Term hereof, such then-current month being called "MO", BTL shall submit to HNS a written update of its twelve (12) month period (by Calendar Quarter)forecast of its orders for DSS Equipment deliveries, such months being called "M1" through "M12". BTL shall provide at its sole cost and expense, a single point of contact for all such forecasts, and by voice access between HNS order management systems and such single point of contact. B. The volumes and Equipment included in X0, X0, and M3 shall constitute a firm non-modifiable, non cancelable purchase order. The volumes and Equipment included in X0, X0, X0, X00, M11 and M12 of each such forecast shall be for planning purposes only and shall not constitute a firm purchase order. Each M4 forecast shall constitute a firm, non-modifiable, non-cancelable purchase order for at least 50% of the beginning volume stated therein, each M5 forecast shall constitute a firm, non-modifiable, non-cancelable purchase order for at least 30% of such the volume stated therein and each M6 forecast shall constitute a firm, non-modifiable, noncancelable purchase order for at least 20% of the volume state therein. In addition, the relative proportions of the DSS Equipment included in the M4, M5 and M6 forecasts may not be changed unless HNS agrees that it has the material available for making a requested change. HNS will make reasonable efforts to respond to BTL's requests to change DSS Equipment stated in M4, M5 and M6 of the twelve (12) month period shall provide GalaGen with an updated forecast for the last three (3) Calendar Quarters of such twelve (12) month period and for the Calendar Quarter following immediately thereafter. Thereafter, at least ninety (90) days before the end of each subsequent Calendar Quarter, Wyeth-Ayerst shall provide a written updated forecast (by Calendar Quarter) in accordance with the provisions of Section 2.3.2 hereofforecasts. 2.3.2 Each successive forecast shall update the forecast previously given for the last three (3) Calendar Quarters covered and add a forecast for the Calendar Quarter following immediately thereafter, to enable GalaGen to have sufficient information to schedule its or its sub-contractors' manufacturing operations to meet Wyeth-Ayerst's forecasted requirements of the Ingredient. GalaGen acknowledges that such forecasts are only estimates of Wyeth-Ayerst's purchase requirements of the Ingredient and that Wyeth-Ayerst shall not be bound by any such estimate, except that after Regulatory Approval the first Calendar Quarter of each successive forecast so provided shall represent a binding commitment of Wyeth-Ayerst to purchase and of GalaGen to supply such forecasted quantity of Ingredient in a timely manner, subject to adjustment within the limits set forth in Section 2.3.4 hereof. 2.3.3 Wyeth-Ayerst C. BTL shall order purchases of DSS Equipment hereunder by written purchase orders. The terms and maintain reasonable inventories of the Ingredient, having due regard to its current and forecasted sales volumes for the Products. Wyeth-Ayerst shall issue to GalaGen firm purchase orders for each delivery not later than two (2) months prior to the requested delivery date. Such purchase orders shall specify the quantity of Ingredient desired, and the place(s) to which and the manner and dates by which delivery is to be made. To the extent the terms of any purchase order or acknowledgment thereof are inconsistent with the terms of this Agreement, the terms conditions of this Agreement shall control. 2.3.4 The quantity of Ingredient ordered by Wyeth-Ayerst supersede any inconsistent provisions contained in BTL's purchase orders and in HNS's order acknowledgement, confirmation and invoice forms. Any inconsistent terms and conditions in any Calendar Quarter such forms used by either party hereto, shall be null and void unless adopted by BTL and HNS as an explicit written amendment to this Agreement. Each purchase order shall be subject to HNS's written acceptance thereof, which acceptance shall not be less than seventy-five percent (75%) unreasonably withheld. Shipment of the quantity specified DSS Equipment shall be scheduled in the last binding forecast provided by Wyeth-Ayerst for accordance with such Calendar Quarter. Additionally, GalaGen shall not be obligated to supply that quantity of Ingredient in any Calendar Quarter that is more than one hundred and twenty-five percent (125%) of the last binding forecast provided by Wyeth-Ayerst for the Calendar Quarter in question; PROVIDED, HOWEVER, that GalaGen shall endeavor to take all reasonable steps to fill purchase orders for the Ingredient in excess and HNS's acceptance of such amountpurchase orders. 2.3.5 All estimates shall be prepared in good faith in order to facilitate GalaGen's efficient manufacture and shipment of the Ingredient in compliance with this Agreement, and except as set forth in Section 2.3.2 will not be binding upon Wyeth-Ayerst or GalaGen in any way and Wyeth-Ayerst shall not be responsible for any loss or expense of GalaGen's arising from the forecast. 2.3.6 Notwithstanding any other provision of this Agreement, GalaGen in no event shall be obligated to supply Wyeth-Ayerst with an amount of Ingredient that exceeds seventy percent (70%) of GalaGen's total capacity for the manufacture of Ingredient and all other products. In the event Wyeth-Ayerst provides GalaGen with good faith forecasts that exceed such capacity, GalaGen agrees that it will use its Commercially Reasonable Efforts to seek and employ subcontractors, as permitted under Section 2.1 hereof, to manufacture such excess amounts of Ingredient on commercially reasonable terms.

Forecasts and Orders. 2.3.1 Not later than six months after submission of the NDA for a Product or other applicable regulatory filing, CYTOB will provide AMAR with a 12-month forecast of CYTOB’s requirement of each Product, which forecast will include designation of whether such Product shall be provided in bulk or Unit form, for which 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 twelve (12) months 45 days prior to its 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 purchase two quarters of Ingredient for use the 12-month forecast will be stated in monthly requirements. AMAR will inform HBL and ask HBL to stock a minimum amount of 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 ­­­­­_____% per month until fixed by the subsequent forecast; provided that the aggregate adjustment from the quantity set forth in the manufacture of Products to be sold to Third Parties, Wyethprevious forecast for such three-Ayerst shall provide GalaGen with a written forecast (by Calendar Quarter) of the quantity of Ingredient that Wyeth-Ayerst desires to have delivered to it during the first twelve (12) month period of Product salesshall not exceed _____% in aggregate during that three-month period. Within six (6) months prior to its first purchase of IngredientFor example, Wyeth-Ayerst shall provide GalaGen with an updated if CYTOB’s forecast for the first twelve (12) three months was for _____ Units and its forecast for the second three months was for _____ Units, the maximum number of Units CYTOB could order at the time the second three-month period becomes fixed would be _____ Units (by Calendar Quarteri.e., _____% of _____ Units plus the _____ 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, and by CYTOB will provide to AMAR a rolling 12-month forecast for 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 such twelve (12) month period shall provide GalaGen with an updated forecast each month. All orders will be for the last three (3) Calendar Quarters of such twelve (12) month period and for the Calendar Quarter following immediately thereafterfull batch quantities. Thereafter, at least ninety (90) days before the end of each subsequent Calendar Quarter, Wyeth-Ayerst shall provide a written updated forecast (by Calendar Quarter) It is understood that AMAR will not maintain Product inventory. Nothing in accordance with the provisions of Section 2.3.2 hereof. 2.3.2 Each successive forecast shall update the forecast previously given for the last three (3) Calendar Quarters covered and add a forecast for the Calendar Quarter following immediately thereafter, to enable GalaGen to have sufficient information to schedule its or its sub-contractors' manufacturing operations to meet Wyeth-Ayerst's forecasted requirements of the Ingredient. GalaGen acknowledges that such forecasts are only estimates of Wyeth-Ayerst's purchase requirements of the Ingredient and that Wyeth-Ayerst shall not be bound by any such estimate, except that after Regulatory Approval the first Calendar Quarter of each successive forecast so provided shall represent a binding commitment of Wyeth-Ayerst to purchase and of GalaGen to supply such forecasted quantity of Ingredient in a timely manner, subject to adjustment within the limits set forth in Section 2.3.4 hereof. 2.3.3 Wyeth-Ayerst shall order and maintain reasonable inventories of the Ingredient, having due regard to its current and forecasted sales volumes for the Products. Wyeth-Ayerst shall issue to GalaGen firm purchase orders for each delivery not later than two (2) months prior to the requested delivery date. Such purchase orders shall specify the quantity of Ingredient desired, and the place(s) to which and the manner and dates by which delivery is to be made. To the extent the terms of any purchase order or acknowledgment thereof are inconsistent with the terms of this Agreement, the terms of this Agreement shall control. 2.3.4 The quantity obligate AMAR to stock Product. CYTOB agrees to purchase a sufficient amount of Ingredient ordered by WyethProduct to enable CYTOB to carry sufficient inventory to allow for fluctuations in sales demand so as to allow AMAR reasonable lead-Ayerst time to meet increased demand. AMAR will use commercially reasonable efforts to meet any increase in any Calendar Quarter shall not be less than seventy-five percent (75%) demand in excess of the quantity specified in the last binding forecast provided by Wyeth-Ayerst for such Calendar Quarter. Additionallyallowed adjustment, GalaGen shall but will not be obligated to supply that quantity of Ingredient in any Calendar Quarter that is more than one hundred and twenty-five percent (125%) of the last binding forecast provided do so. All forecasts will be made by Wyeth-Ayerst for the Calendar Quarter in question; PROVIDED, HOWEVER, that GalaGen shall endeavor CYTOB to take all reasonable steps to fill purchase orders for the Ingredient in excess of such amount. 2.3.5 All estimates shall be prepared AMAR in good faith based upon standard commercial parameters. From time to time after the Effective Date, the Parties shall consider whether, in order light of market demand, manufacturing capacity, inventory levels and other pertinent factors, to facilitate GalaGen's efficient manufacture and shipment revise the schedule for delivery of the Ingredient forecasts and, if appropriate, negotiate in compliance with this Agreement, and except as set forth in Section 2.3.2 will not be binding upon Wyeth-Ayerst or GalaGen in any way and Wyeth-Ayerst shall not be responsible for any loss or expense of GalaGen's arising from the forecast. 2.3.6 Notwithstanding any other provision of this Agreement, GalaGen in no event shall be obligated to supply Wyeth-Ayerst with an amount of Ingredient that exceeds seventy percent (70%) of GalaGen's total capacity for the manufacture of Ingredient and all other products. In the event Wyeth-Ayerst provides GalaGen with good faith forecasts that exceed to revise such capacity, GalaGen agrees that it will use its Commercially Reasonable Efforts to seek and employ subcontractors, as permitted under Section 2.1 hereof, to manufacture such excess amounts of Ingredient on commercially reasonable termsschedule.

Forecasts and Orders. 2.3.1 Not later than six months after submission of the NDA for a Product or other applicable regulatory filing on a country-by-country basis, BME will provide ABI with a 12-month forecast of BME's requirement of each Product, which forecast will include designation of whether such Product shall be provided in bulk or Unit form, for which 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 twelve (12) months 45 days prior to its 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 purchase two quarters of Ingredient for use the 12-month forecast will be stated in monthly requirements. The second two quarters of the 12-month forecast 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 manufacture of Products to be sold to Third Parties, Wyethprevious forecast for such three-Ayerst shall provide GalaGen with a written forecast (by Calendar Quarter) of the quantity of Ingredient that Wyeth-Ayerst desires to have delivered to it during the first twelve (12) month period of Product salesshall not exceed 50% in aggregate during that three-month period. Within six (6) months prior to its first purchase of IngredientFor example, Wyeth-Ayerst shall provide GalaGen with an updated if BME's forecast for the first twelve (12) three months was for 100 Units and its forecast for the second three months was for 200 Units, the maximum number of Units BME could order at the time the second three-month period becomes fixed would be 300 Units (by Calendar Quarteri.e., 50% of 200 Units plus the 200 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, and by BME will provide to ABI a rolling 12-month forecast for 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 such twelve (12) month period shall provide GalaGen with an updated forecast each month. All orders will be for full batch quantities. **** Indicates that a portion of the last three (3) Calendar Quarters of such twelve (12) month period text has been omitted and for the Calendar Quarter following immediately thereafter. Thereafter, at least ninety (90) days before the end of each subsequent Calendar Quarter, Wyeth-Ayerst shall provide a written updated forecast (by Calendar Quarter) in accordance filed separately with the provisions of Section 2.3.2 hereof. 2.3.2 Each successive forecast shall update the forecast previously given for the last three (3) Calendar Quarters covered and add a forecast for the Calendar Quarter following immediately thereafter, to enable GalaGen to have sufficient information to schedule its or its sub-contractors' manufacturing operations to meet Wyeth-Ayerst's forecasted requirements Commission. It is understood that ABI will not maintain Product inventory in excess of the Ingredientapplicable forecast, but will produce Product upon receipt of that portion of BME's forecasts that constitute firm orders to purchase. GalaGen acknowledges that such forecasts are only estimates of Wyeth-Ayerst's purchase requirements of the Ingredient and that Wyeth-Ayerst shall not be bound by any such estimate, except that after Regulatory Approval the first Calendar Quarter of each successive forecast so provided shall represent a binding commitment of Wyeth-Ayerst to purchase and of GalaGen to supply such forecasted quantity of Ingredient Nothing in a timely manner, subject to adjustment within the limits set forth in Section 2.3.4 hereof. 2.3.3 Wyeth-Ayerst shall order and maintain reasonable inventories of the Ingredient, having due regard to its current and forecasted sales volumes for the Products. Wyeth-Ayerst shall issue to GalaGen firm purchase orders for each delivery not later than two (2) months prior to the requested delivery date. Such purchase orders shall specify the quantity of Ingredient desired, and the place(s) to which and the manner and dates by which delivery is to be made. To the extent the terms of any purchase order or acknowledgment thereof are inconsistent with the terms of this Agreement, the terms of this Agreement shall control. 2.3.4 The quantity obligate ABI to deliver Product if HBL is unable for any reason to provide Product. BME agrees to purchase a sufficient amount of Ingredient ordered by WyethProduct to enable BME to carry sufficient inventory to allow for fluctuations in sales demand so as to allow ABI reasonable lead-Ayerst time to meet increased demand. ABI will use commercially reasonable efforts to meet any increase in any Calendar Quarter shall not be less than seventy-five percent (75%) demand in excess of the quantity specified in the last binding forecast provided by Wyeth-Ayerst for such Calendar Quarter. Additionallyallowed adjustment, GalaGen shall but will not be obligated to supply that quantity of Ingredient in any Calendar Quarter that is more than one hundred and twenty-five percent (125%) of the last binding forecast provided do so. All forecasts will be made by Wyeth-Ayerst for the Calendar Quarter in question; PROVIDED, HOWEVER, that GalaGen shall endeavor BME to take all reasonable steps to fill purchase orders for the Ingredient in excess of such amount. 2.3.5 All estimates shall be prepared ABI in good faith based upon standard commercial parameters. From time to time after the Effective Date, the Parties shall consider whether, in order light of market demand, manufacturing capacity, inventory levels and other pertinent factors, to facilitate GalaGen's efficient manufacture and shipment revise the schedule for delivery of the Ingredient forecasts and, if appropriate, negotiate in compliance with this Agreement, and except as set forth in Section 2.3.2 will not be binding upon Wyeth-Ayerst or GalaGen in any way and Wyeth-Ayerst shall not be responsible for any loss or expense of GalaGen's arising from the forecast. 2.3.6 Notwithstanding any other provision of this Agreement, GalaGen in no event shall be obligated to supply Wyeth-Ayerst with an amount of Ingredient that exceeds seventy percent (70%) of GalaGen's total capacity for the manufacture of Ingredient and all other products. In the event Wyeth-Ayerst provides GalaGen with good faith forecasts that exceed to revise such capacity, GalaGen agrees that it will use its Commercially Reasonable Efforts to seek and employ subcontractors, as permitted under Section 2.1 hereof, to manufacture such excess amounts of Ingredient on commercially reasonable termsschedule.

Forecasts and Orders. 2.3.1 Not less than twelve (12a) months prior Dentsply shall provide Forecasts and Firm Orders for Products in whole Batches in accordance with the procedures set forth in Section 2.3(b). AZ shall use commercially reasonable efforts to its first purchase of Ingredient for use deliver Product in accordance with timelines set forth in the manufacture Firm Orders submitted by Dentsply as set forth in Section 2.3(b). (b) Commencing on December 1, 2003 (the "Initial Forecast Date"), Dentsply will provide AZ a forecast of Products to be sold to Third Parties, Wyeth-Ayerst shall provide GalaGen with Dentsply's requirements in Batches for each Product for each month for a written forecast (by Calendar Quarter) of the quantity of Ingredient that Wyeth-Ayerst desires to have delivered to it during the first twelve (12) month period of Product sales. Within six (6) months prior to its first purchase of Ingredient, Wyeth-Ayerst shall provide GalaGen with an updated forecast for the first twelve (12) month period (by Calendar Quartera "Forecast"); provided, and by 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 period, or (ii) through the remaining period to termination of such this Agreement, with the first three (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 GalaGen with an updated forecast 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 last 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) Calendar Quarters of such twelve (12) month period and for the Calendar Quarter following immediately thereafter. Thereafter, at least ninety (90) days before the end of each subsequent Calendar Quarter, Wyeth-Ayerst shall provide a written updated forecast (by Calendar Quarter) in accordance with the provisions of Section 2.3.2 hereof. 2.3.2 Each successive forecast shall update the forecast previously given for the last three (3) Calendar Quarters covered and add a forecast for the Calendar Quarter following immediately thereafter, to enable GalaGen to have sufficient information to schedule its or its sub-contractors' manufacturing operations to meet Wyeth-Ayerst's forecasted requirements of the Ingredient. GalaGen acknowledges that such forecasts are only estimates of Wyeth-Ayerst's purchase requirements of the Ingredient and that Wyeth-Ayerst shall not be bound by any such estimate, except that after Regulatory Approval the first Calendar Quarter of each successive forecast so provided shall represent a binding commitment of Wyeth-Ayerst to purchase and of GalaGen to supply such forecasted quantity of Ingredient in a timely manner, subject to adjustment within the limits set forth in Section 2.3.4 hereof. 2.3.3 Wyeth-Ayerst shall order and maintain reasonable inventories of the Ingredient, having due regard to its current and forecasted sales volumes for the Products. Wyeth-Ayerst shall issue to GalaGen firm purchase orders for each delivery not later than two (2) months prior to the first day of such month. (c) AZ will respond within 10 business days of receiving from Dentsply the monthly rolling Forecast and Firm Order and will either (i) confirm acceptance by AZ of the Forecast and Firm Order quantities or (ii) reject the requested delivery datequantities and initiate a dialogue between the Parties to arrive at mutually acceptable values for the Forecast and Firm Order. Such purchase orders shall specify the AZ will use commercially reasonable efforts to accommodate any additional quantity of Ingredient desiredProducts requested by Dentsply after the Firm Order has been sent to AZ, and the place(s) to which and the manner and dates by which delivery is to be made. To the extent the terms of any purchase order or acknowledgment thereof are inconsistent with the terms of this Agreement, the terms of this Agreement shall control. 2.3.4 The quantity of Ingredient ordered by Wyeth-Ayerst in any Calendar Quarter but AZ shall not be less liable in any respect for its inability to do so. Notwithstanding anything in this Agreement to the contrary, AZ shall have no obligation to Manufacture in any month more than seventy-five percent (75%) 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 amended only by mutual agreement of the quantity specified Parties, in the last binding forecast provided by Wyeth-Ayerst for such Calendar Quarter. Additionally, GalaGen shall not be obligated to supply that quantity of Ingredient in any Calendar Quarter that is more than one hundred and twenty-five percent (125%) of the last binding forecast provided by Wyeth-Ayerst for the Calendar Quarter in question; PROVIDED, HOWEVER, that GalaGen shall endeavor to take all reasonable steps to fill purchase orders for the Ingredient in excess of such amountwriting. 2.3.5 All estimates shall be prepared in good faith in order to facilitate GalaGen's efficient manufacture and shipment of the Ingredient in compliance with this Agreement, and except as set forth in Section 2.3.2 will not be binding upon Wyeth-Ayerst or GalaGen in any way and Wyeth-Ayerst shall not be responsible for any loss or expense of GalaGen's arising from the forecast. 2.3.6 Notwithstanding any other provision of this Agreement, GalaGen in no event shall be obligated to supply Wyeth-Ayerst with an amount of Ingredient that exceeds seventy percent (70%) of GalaGen's total capacity for the manufacture of Ingredient and all other products. In the event Wyeth-Ayerst provides GalaGen with good faith forecasts that exceed such capacity, GalaGen agrees that it will use its Commercially Reasonable Efforts to seek and employ subcontractors, as permitted under Section 2.1 hereof, to manufacture such excess amounts of Ingredient on commercially reasonable terms.