Common use of FORECAST AND SUPPLY Clause in Contracts

FORECAST AND SUPPLY. (1) The parties shall work on the basic premise that Unigene shall at all times endeavor to give Sandoz as much advance notice as possible of any changes in its forecasts, and Sandoz shall use its commercially reasonable efforts to accommodate such changes. (a) Non binding rolling forecast. Unigene will use its best efforts in planning and investigating its requirements and will starting by ** provide for API, a rolling three (3) calendar year forecast and will update such forecast yearly. (b) Rolling Commercial Forecasts, Firm Orders. Upon the earlier of Regulatory Approval by FDA or EMEA of Unigene’ s Oral Product the forecast shall consist of (i) a Firm Order for API for Calendar Year 1 of such three (3) year forecast, and (ii) requirements for API for the subsequent calendar years 2 and 3. The forecasts for subsequent calendar years 2 and 3 shall be updated quarterly, and shall be a Firm Order for each subsequent year upon June 30 for the subsequent Calendar Year and **% of such forecasted requirements for the subsequent calendar year 2 shall constitute a binding minimum requirement to the extent exceeding ** kg. (subsequent calendar year 2 being the calendar year immediately following that for which a Firm Order is provided) (collectively such information is referred to as a “Rolling Commercial Forecast”). Except for separate agreement Unigene agrees that it will not deliver a Firm Order for API that will require Manufacture of API in excess of ** per calendar year at ** w.v. scale or requires Manufacture at ** w.v. Firm Orders which Unigene may place before Regulatory Approval shall be placed also not later than by June 30 of the previous year and shall not require Manufacture of API before **, unless agreed otherwise by the parties. Such Firm Orders shall not be for less than ** of API. (c) Initial Seven Year Forecast. Unigene’s current non-binding seven (7) year forecast for API is attached as Schedule 5 for information purposes only. (2) With respect to each Firm Order (a) Unigene will be obligated to purchase ** of the quantity of API set forth in such Firm Order and (b) Sandoz will be obligated to fulfill ** of the quantity of API set forth in the Firm Order, except as justified by Batch volumes based on the number of ** of API ordinarily produced per Batch and provided that the Firm Order shall not exceed the previous year’s forecast for such calendar year (i.e., when the year was the second year of a Rolling Commercial Forecast) by more than **. In the event Unigene requests API from Sandoz in excess of ** of the Firm Order (“Excess Orders”), Sandoz will use its commercially reasonable efforts to accommodate such Excess Orders consistent with this Agreement (including, without limitation, upon financial terms no higher than described herein) in an attempt to meet Unigene’s requirements for the API. Sandoz shall inform Unigene whether it will fill Excess Orders within thirty (30) days of receiving the applicable Firm Order so as to permit Unigene to manage its inventory of API and respond to market demand. (3) The parties agree that manufacture of API will be conducted in principle at the ** w.

FORECAST AND SUPPLY. (1) The parties shall work on the basic premise that Unigene Amylin shall at all times endeavor to give Sandoz as much advance notice as possible of any changes in its forecasts, and Sandoz shall use its commercially reasonable efforts to accommodate such changes. (a2) Non Amylin’s current non-binding rolling forecast. Unigene [***] forecast for Product is attached as Schedule 9 for information purposes only. (3) Amylin will use its best efforts in planning and investigating estimating its requirements and will starting by ** provide for APIto Sandoz, a rolling three (3) calendar year [***] forecast for the Product by [***] and will update such forecast yearly. (b4) Rolling Commercial Forecasts, Firm Orders. Upon [***] from the earlier granting of Regulatory Approval regulatory approval of the Amylin Finished Product by FDA or EMEA EMA, and thereafter before [***] of Unigene’ s Oral each subsequent calendar year, Amylin will provide to Sandoz a rolling forecast of its entire demands for Product of Amylin, its Affiliates and licensees for the [***] following the year in which the forecast shall consist of is provided (i) a Firm Order for API for Calendar Year 1 of each such three (3) year forecast, and (ii) requirements for API for the subsequent calendar years 2 and 3. The forecasts for subsequent calendar years 2 and 3 shall be updated quarterly, and shall be a Firm Order for each subsequent year upon June 30 for the subsequent Calendar Year and **% of such forecasted requirements for the subsequent calendar year 2 shall constitute a binding minimum requirement to the extent exceeding ** kg. (subsequent calendar year 2 being the calendar year immediately following that for which a Firm Order is provided) (collectively such information is referred to as forceast a “Rolling Commercial Forecast”), provided that the amount of Product forecasted for any individual calendar year in the Rolling Commercial Forecast (i) will be comprised of a minimum campaign size of [***] Engineering Batch and [***] cGMP Batches, (ii) shall be suitable for Manufacture in [***] consecutive production campaign, and (iii) until otherwise agreed to by Amyln and Sandoz, will require a production capacity of no more than [***] per year at the RPP4 Facility. Except Each Rolling Commercial Forecast will consist of (i) Firm Order for separate agreement Unigene Product for [***] forecast, and (ii) non-binding forecasted demands for Product for the subsequent [***]. If Amylin issues a Rolling Commercial Forecast that is not in line with the requirements set out above under (ii) and (iii), Sandoz agrees that it will not deliver a Firm Order use its commercially reasonable efforts to accommodate such deviating demands consistent with this Agreement (including, without limitation, upon financial terms no higher than described herein) in an attempt to meet Amylin’s requirements for API that the Product, and will require Manufacture inform Amylin whether it will fill such deviating demands within [***] of API in excess receiving the applicable order so as to permit Amylin to manage its inventory of ** per calendar year at ** w.v. scale or requires Manufacture at ** w.v. Product and respond to market demand. (5) Firm Orders which Unigene may place placed by Amylin before Regulatory Approval shall be placed also not later than by June 30 [***] of the previous year and shall not require Manufacture of API before **year, unless agreed otherwise by the parties. Such Firm Orders shall not be for less than ** of API. (c) Initial Seven Year Forecast. Unigene’s current non-binding seven (7) year forecast for API is attached as Schedule 5 for information purposes only. (26) With respect to each Firm Order (a) Unigene Amylin will be obligated to purchase [** **] of the quantity of API Product set forth in such Firm Order and (b) Sandoz will be obligated to fulfill Manufacture [** **] of the quantity of API Product set forth in the Firm Order, except as justified by Batch volumes based on the number of ** kg of API Product ordinarily produced per Batch Batch, and provided that the Firm Order shall not exceed the previous year’s forecast for such calendar year (i.e., when the year was the second year of a Rolling Commercial Forecast) by more than [***]. In the event Unigene Amylin requests API Product from Sandoz in excess of (i) [** **] of the Firm Order Order, (ii) the amounts of Product set forth in the applicable Rolling Commercial Forecast, or (iii) an amount of Product for which the Manufacture requires more than [***] of production capacity at the RPP4 Facility per calendar year (in each case an “Excess OrdersOrder”), Sandoz will use its commercially reasonable efforts to accommodate such Excess Orders consistent with this Agreement (including, without limitation, upon financial terms no higher than described herein) in an attempt to meet UnigeneAmylin’s requirements for the APIProduct. Sandoz shall inform Unigene Amylin whether it will fill Excess Orders within thirty (30) days [***] of receiving the applicable Firm Order so as to permit Unigene Amylin to manage its inventory of API Product and respond to market demand. (37) The parties agree that manufacture any Manufacture of API Product under this Agreement will be conducted in principle at the [** w.**] w.v. scale. In planning the supply of Product for the following year, Sandoz shall agree in advance with Amylin which capacity of manufacture will be utilized, and in doing so, Sandoz shall use commercially reasonable efforts that Amylin’s supply requirements and all regulatory requirements (including the provision by Sandoz of validation and regulatory support if necessary) are met.