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CAPACITY AGREEMENT (Commitment per batch based on delivery), FORECASTING and other supply chain terms
MoonLake and Vetter wish to have certain Facility capacity (for filling, secondary packaging or assembly) reserved for Manufacture of Product for certain years. Therefore, both Parties agree to attach the following capacity agreement (the “Capacity Agreement”) to Product Schedule No. 1:
In case of conflict between this Capacity Agreement and the Master Commercial Supply Agreement, the Capacity Agreement shall prevail.
1.Forecasting
1.1The following shall apply for the Product:
The forecast is designed for ordering and forecasting in quantities. The average batch size, which shall serve as a reference for the MoonLake Commitment (as defined in Section 1.2 and 2) in number of batches as defined in this Section as well as for the Vetter Commitment (as defined in Section 1.7 and 2) for batches of Product shall be:
| | | | | | | | | | | |
| Year | Average amount of drug substance | Average batch size | Clean Room |
| 2027 and following years | [***] | [***] | [***] |
The quantity must be a multiple of an average batch size only. Quantity in the meaning of this Capacity Agreement is defined due to the definition in the table in Section 2 in number of batches.
1.2The Long Range Forecast shall be submitted to Vetter annually in writing. Before August 8th of each calendar year, MoonLake shall provide a successive updated long range forecast thereof (each update, the “Updated Long Range Forecast”; and the Initial Long Range Forecast and any Updated Long Range Forecast hereinafter the “Long Range Forecasts” and each a “Long Range Forecast”). The Long Range Forecast shall show the MoonLake requirements related to a calendar year (each, the “Annual Demand”) within that [***]-period. Significant forecast changes should be indicated to Vetter [***] and need to be discussed together with its impact and Vetter will inform MoonLake about potential measures to allow for such demand, including the need for procurement of additional equipment, transfer to another cleanroom at MoonLake’s cost.
1.3MoonLake Commitment. The first [***] of any Long Range Forecast (i.e. the Annual Demands for the first [***]) shall be binding to MoonLake and shall be considered a rolling MoonLake capacity reservation commitment for each [***] period once it has been confirmed by Vetter subject to Section 1.7 and 1.8 (hereinafter the “MoonLake Commitment”). The MoonLake Commitment cannot be modified (increased or decreased) other than as set forth in the following Section 1.4 and 1.5. For illustration purposes, please see Section 2 and 3. Calendar years [***] to [***] of any Long Range Forecast shall be non-binding and for MoonLake and Vetter planning purposes only, provided however, it is agreed and understood by MoonLake that once calendar year [***] of any Long Range Forecast becomes calendar year [***] such Annual Demand becomes, once confirmed by Vetter, part of the MoonLake Commitment.
1.4The aggregate quantities for Product set forth in MoonLake Commitment
a.shall be ordered by MoonLake in units within the average batch size set forth in Section 1.1. In the event it turns out that, after the PPQ runs, the average batch size defined in Section 1.1 cannot be reached for whatever reason, the Parties acknowledge and agree that this will have an impact on the yearly utilization of the Vetter cleanroom capacity and will therefore cause necessary adjustments of the batch numbers set forth in the Annual Demand as outlined in the Long Range
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Forecast, but shall not result in an obligation for Vetter to reserve more time in the cleanroom than already confirmed (based on the average batch size);
b.may not be increased by MoonLake without Vetter´s prior written consent. Therefore, the respective maximum quantity shall be the quantity (i) specified in the Initial Long Range Forecast of the first [***], and the quantities (ii) specified for the first [***] in an Updated Long Range Forecast, if and to the extent approved by Vetter, as described in Section 1.8. (each a “Maximum Quantity”).
c.Additional quantities may be ordered by MoonLake in accordance with Sections 1.13, 2, 3 and 4; and
i.may be decreased by MoonLake in the [***] of any Long Range Forecast by no more than [***] percent;
ii.in the [***] of any Long Range Forecast by no more than [***] percent;
iii.in the [***] of any Long Range Forecast by no more than [***] percent; and
iv.in the [***] of any Long Range Forecast by no more than [***] percent;
in each case from the Annual Demand that was initially provided for the first time in the Long Range Forecast (the “Minimum Quantity”). MoonLake may not reduce the Annual Demand of the first calendar year of any Long Range Forecast and may not reduce the Annual Demand of the following calendar years of any Long Range Forecast below the respective, the first time committed Minimum Quantity in any calendar year, without running into the obligation to pay Capacity Compensation as defined in Section 1.20.
d.Against this background the following volumes within MoonLake Commitment are fully binding: [***]
e.It is agreed by the Parties that any such Maximum Quantity and Minimum Quantity per Annual Demand shall apply to the entire [***] period and that no further increase or decrease of the Maximum Quantity and Minimum Quantity is allowed once [***] becomes [***] respectively in the immediate successive Long Range Forecast.
1.5Launch Phase. MoonLake’s expected launch date for Product is [***] (“Expected Product Launch Date”) with the first launch volume of the Product being produced until the end of [***]. The phase between the execution of the Product Schedule and the year of the Expected Product Launch Date shall be the “Pre-Launch Phase”. The phase thereafter until [***], shall be the “Post Launch Phase”. Both periods, the “Pre-Launch Phase” and the “Post-Launch Phase” together, herein the “Launch Phase”.
In this context the following shall apply:
Other than set forth in Section 1.4, Vetter provides MoonLake with an additional [***] percent [***] flexibility for the Minimum Quantity during the Launch Phase as follows:
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For illustration purposes, Section 6 outlines the timeline for the Launch Phase. Latest with the [***] Long Range Forecast, the Launch Phase will be ended with the year [***]. For the [***] the quantity commitment will be then [***]% for both Parties as set forth in Section 1.4 (c).
Any delay for market authorizations which is not caused by MoonLake in any way, but solely by actions or inactions of the applicable Regulatory Authorities (for which MoonLake provides correct and valid information) and which has an impact on the Expected Product Launch Date, has to be discussed [***] between the Parties.
1.6Rounding Rules. In case MoonLake increases or decreases its demand batch quantities shall be rounded according to the general rounding rules:
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Rounding to a full batch: 0.50 rounding down, 0.51 rounding up and for low volumes (i.e. no more than [***] batches per calendar year). Further the following shall apply:
| | | | | | | | |
| Forecasted number of batches per calendar year | Maximum batches | Minimum batches |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
| [***] | [***] | [***] |
1.7Vetter Commitment. Vetter accepts the Initial Long Range Forecast as provided by MoonLake and attached hereto in Section 2 and hereby commits itself to reserve filling capacity in the cleanrooms listed in Section 1.1 for delivery, in an equivalent of the respective Maximum Quantity per year in batches set forth in the first [***] (the “Vetter Commitment”). The Vetter Commitment shall be binding to Vetter.
1.8Confirmation new year [***] of the updated Long Range Forecast. With regard to any Updated Long Range Forecast, Vetter shall inform MoonLake in quarter four of each calendar year (during the Parties’ regular business review meeting or a comparable management meeting) about Vetter’s capability to provide the capacity requested by MoonLake in calendar year [***] of any Updated Long Range Forecast. Upon Vetter’s positive confirmation, Vetter commits itself to reserve further filling capacity for delivery in an equivalent (or part thereof, as the case may be) of the Annual Demand set forth in such newly added [***] calendar year and such confirmed reservation obligation then becomes part of the Vetter Commitment.
1.9Clean Room Transfer Option. The Parties shall discuss during their business review meeting or other suitable meetings the total of MoonLake’s Annual Demands for each of the following [***] and Vetter shall indicate to MoonLake the current capacity status of the cleanrooms used for Manufacture of Product for the new calendar years [***] to [***]. Such information, although being a non-binding information, shall be complete, accurate and reflect Vetter´s best current operational planning and constraints. The Maximum Quantity out of Cleanroom [***] is limited to currently [***] per year with the average batch size as set forth in Section 1.1. Any quantities above could only be covered through a clean room transfer. Vetter shall proactively notify MoonLake [***], that a cleanroom transfer may be required to meet MoonLake’s forecasted or contracted demand. Any such transfer would have to be initiated in any case at the latest [***] in advance;
1.10Major Changes. Major demand and capacity changes at the Facility (increase/decrease), which may impact the MoonLake Commitment shall be, [***], discussed between the Parties. [***]
1.3Rolling Forecast. MoonLake shall provide Vetter for Product, on or before the 7th calendar day of each [***], a detailed written, [***] rolling forecast showing quantities to be delivered under the Capacity Agreement together with the expected [***] of delivery (hereinafter the initially so provided [***] rolling forecast and any [***] update thereof hereinafter the “[***] Rolling Forecast”). Such [***] Rolling Forecast shall show the MoonLake demand in full batch quantities (Product units), beginning with [***].
For Example, [***].
1.11Requested quantities shall be evenly distributed over all of the [***] of each [***] Rolling Forecast and shall be well balanced in order to avoid capacity constraints. “Rear-loading”, “front loading” or other demand peaks, (e.g. for MoonLake’s stock building) other than a balanced order, shall be
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communicated to Vetter upfront, as they require a prior capacity feasibility check by Vetter, and shall be expressly agreed upon between Vetter and MoonLake.
1.12Each [***] Rolling Forecast shall be provided by MoonLake in accordance with Section 1.11 and shall meet any MoonLake Commitment (including any Minimum Quantities and Maximum Quantities in the Capacity Agreement).
In case the Product quantities requested in any [***] Rolling Forecast fall below MoonLake’s Minimum Quantity, Vetter shall have the right to sell off the delta manufacturing capacity between Minimum Quantity and the specified amount in the [***] Rolling Forecast for a MoonLake demand reduction in the Flexible Period as defined in Section 1.15. It is agreed and understood that Vetter will not be required to prove any such “offerings to other customers”, but only state upon request that its [***] efforts to sell the free-up capacities have been or have not been successful. If Vetter is not able to sell the free-up capacities, compensation may apply according to 1.20. However, such compensation shall be limited solely to the shortfall directly and indirectly caused by MoonLake’s reduction.
A decrease in the [***] Rolling Forecast also causes a reduction of the base line and the Maximum Quantity obligation of Vetter (Vetter Commitment in the respective calendar year). In case the free-up capacities can be successfully sold in accordance with the foregoing, MoonLake shall only be charged a [***] percent handling fee of the then current price for such capacity.
In case the Product quantities requested in the [***] Rolling Forecast exceed the Maximum Quantity for the applicable calendar year, Vetter may reject the overage, unless Vetter agrees to increase the capacity as stated in Section 1.4 and 1.5. The Minimum Quantity commitment will be then increased as well. Any disputes and/or discrepancies with regard to the [***] Rolling Forecast shall be discussed between the Parties in accordance with the Minimum and Maximum commitment in the initial Long Range and any updated Long Range Forecast of the Capacity Agreement.
1.13Binding Period. The quantities set forth in any [***] Rolling Forecast for the first [***] shall constitute a firm and binding commitment and cannot be changed by MoonLake (whether increased or decreased) or cancelled in any way (“Binding Period”) without running into an obligation to pay capacity compensation as set forth in Section 1.20 and 1.21.
1.14Semi Binding Period. The quantities set forth in any [***] Rolling Forecast in [***] through [***] of each [***] Rolling Forecast (“Semi Binding Period”) shall be deemed binding, as herein set forth below:
The [***] Rolling Forecast provided at the check points in [***], [***], [***] and [***] shall determine the [***] quantities to be purchased in the Semi Binding Period. The first [***] of any such [***] Rolling Forecast provided at the check points defined in this Section are binding (each a “[***] Fix”)
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1.15Within the described [***] following flexibility is allowed:
[***]
For explanation: [***].
Notwithstanding the foregoing, it is agreed and understood by both Parties that any such flexibility provided under this Section during a calendar year shall not modify in any way the MoonLake Commitment and the Minimum Quantity per calendar year (e.g. 100% in the first calendar year), and the Vetter Commitment and the Maximum Quantity per calendar year, all as determined by the Long Range Forecast and the Vetter capacity status as set forth in 1.4 to 1.5. Furthermore, the Parties agree that if MoonLake complies with MoonLake Commitment and the Minimum Quantity per calendar year, a
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shortfall in a [***] Fix in the Flexible Period for the same calendar year shall not lead to additional compensation obligation of MoonLake.
It needs to be considered that the fluctuation range for the entire [***] may not be fully and solely applied to the [***].
Example:
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The aggregate quantities set forth in all [***] Rolling Forecasts for a calendar year have to comply with and meet the Annual Demand as provided in the first [***] of the Long Range Forecast, the applicable MoonLake Commitment as may be adjusted, and the Minimum Quantities and the Maximum Quantities.
The “Annual Reference Quantity” for a calendar year shall mean the sum of the quarterly aggregated quantities (Three Months Fix 1-4) provided by MoonLake within a calendar year.
In case of discrepancy between the [***] Rolling Forecast and the Long Range Forecast, the mechanism defining the interaction between the Annual Reference Quantity and the Long Range Forecast as set forth in Section 1.2 shall apply. In the event the aggregated quantities in [***] Rolling Forecasts for a calendar year (and the Annual Reference Quantity) exceed the agreed Minimum Quantity, such Minimum Quantity shall be adjusted by the exceeding quantities which have been confirmed to be delivered by Vetter in any such calendar year. The same applies to the applicable Maximum Quantity for such calendar year, if exceeded and if Vetter confirmed that any such exceeding quantities can be delivered in such calendar year. If there is no such confirmation by Vetter, neither the Minimum nor the Maximum Quantity of any such calendar year is adjusted (please also refer to Section 4 for illustration purposes).
1.16Binding Period. Calendar month [***] of the [***] Rolling Forecast may be changed the last time in the [***] Rolling Forecast in which such calendar month [***] becomes calendar month [***] and thus fully binding, i.e. it becomes part of the Binding Period.
1.17Additional Quantities. Subject to the Facility’s manufacturing and equipment capacities, other supply commitments, and the urgency of the supply needs of MoonLake, the Parties may mutually agree that additional quantities may be available in excess of the MoonLake Commitment during a) the Binding Period and/or b) the Semi Binding Period and (such quantities, to the extent so in excess, collectively “Additional Quantity”), and as such, MoonLake c) may place a purchase order for the Additional Quantity within the Binding Period; or (d) adjust its demand within Semi Binding Period of the [***] Rolling Forecast in accordance with the terms of the Capacity Agreement. Vetter shall use [***] efforts to accommodate MoonLake ’s request for Additional Quantity.
1.18Annual Reconciliation. In November of each calendar year, the Parties shall jointly review the quantities which have been ordered and confirmed and not otherwise compensated during such calendar year (herein after called “Annually Ordered Quantity”) in a reconciliation meeting (hereinafter called “Reconciliation Meeting”). The Parties must finalize the reconciliation by December of the same calendar year.
1.19Capacity Compensation. In the event that any such Reconciliation Meeting reveals that MoonLake at any time
a.has failed to provide purchase orders for calendar months [***] to [***] of any [***] Rolling Forecast for the manufacture of [***] percent ([***]%); and/or
b.has not met its MoonLake Commitment in the respective calendar year (did not purchase for any Minimum Quantities);
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MoonLake shall compensate Vetter for the specific units of Product that satisfy all applicable compensation criteria, and which has not been ordered in accordance with this Capacity Agreement multiplied by
[***]
(each, as applicable, a “Capacity Compensation”).
The Capacity Compensation shall not apply to:
i.quantities already compensated under the Master Commercial Supply Agreement, or
ii.any overproduction undertaken by Vetter without MoonLake´s prior written authorization
1.20Capacity Compensation formula: In support of Section 1.20 below, the following formula shall apply, to calculate the Capacity Compensation to be paid for the delta of batches ordered according to the [***] Rolling Forecast or Long Range Forecast and the Minimum Quantity (hereinafter called “Omitted Quantity”), in case the Minimum Quantity was not ordered by MoonLake:
[***]
Any capacity that has been successfully sold by Vetter under Section 1.13 is not considered an Omitted Quantity but will be deducted from the Minimum Quantity requirement in the above formula.
1.21Possible Reduction. If in any case the review during the Reconciliation Meeting reveals that MoonLake materially increased the Annual Ordered Quantity in one cleanroom (always provided that this substantial increase was above the defined Maximum Quantity, and occurred with Vetter’s consent) which results in a shortfall in the other cleanroom with Capacity Compensation payment obligation under this Capacity Agreement, the Parties shall discuss [***] if and how this material increase could potentially lead to a reduction of the Capacity Compensation payment for the shortfall.
1.22Freedom of Filling Day. Based on the information provided in the [***] Rolling Forecast, Vetter shall schedule the Manufacture and confirm delivery dates. Filling days shall be communicated to MoonLake. Vetter shall always try to prioritize purchase orders with critical shelf life and MoonLake hereby allows Vetter to expedite or delay MoonLake’s requests for Manufacture under purchase orders, by a maximum of [***], to compile Manufacturing campaigns and to most efficiently use available capacity for its customers, Section 1.15 and 1.16 of the Capacity Agreement shall apply.
1.23Obsolete Materials: If, and to the extent that, purchased Material procured by Vetter in accordance with the Capacity Agreement should become obsolete or unfit for the Manufacture or Product due to
a.changes to the Specifications or GMP, applicable laws, rules and regulations;
b.wilful misconduct or negligence of MoonLake; and/or
c.expiry or termination of this Capacity Agreement or the applicable Product specific appendix (not attributed to Vetter), and Vetter cannot, despite using commercially reasonable efforts, identify other use of such inventory of purchased Material for another customer
MoonLake shall compensate Vetter, by payment of the purchase price of such purchased Material disbursed by Vetter, as well as the reasonable costs for handling and any disposal thereof. Vetter shall use [***] efforts to mitigate the costs (e.g. by cancelling any orders of purchased Material that still can be cancelled without costs or expenses).
1.24Late Delivery of MoonLake Materials: If a non- or late delivery (which means delivery of the active pharmaceutical ingredient (“API”) and/or other MoonLake Material’s in less than the target time of [***] before compounding) of sufficient API in the right quality and with the right documents (without
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having enough safety stock at the Facility) results in the loss of a filling slot, it will be considered as a cancellation of a purchase order, or cancellation of another form of MoonLake Commitment hereunder, and shall be subject to Capacity Compensation payments according to Section 1.20, except if Vetter could re-arrange the filling slots differently to mitigate the damage. In exceptional cases and if MoonLake notifies Vetter [***], the Parties may agree that MoonLake may be entitled to deliver API in less than [***] before compounding, but at the latest [***] before compounding.
2.Initial Long Range Forecast (Vetter Commitment to the Max batches for commercial applicable as well for the Launch Phase MoonLake Commitment to the Min batches for commercial applicable as well for the Launch Phase)
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3.Waterfall Chart Capacity Agreement
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4.[***] Rolling Forecast versus Capacity Agreement
In case the Reference QTY (which is built up via monthly Rolling Forecast herein the Rolling Forecast (RFC)) for CRP with the Minimum and Maximum Reference QTY overrides the Capacity Agreement only if the [***] Rolling Forecast for CRP is higher than the maximum Commitment in the Capacity Agreement (CA), as illustrated below
[***]
5. Rolling Mechanism Capacity Agreement
[***]
6. Launch Phase
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