Production, Forecasts & Orders. Xxxxxx shall commence Production of Client Product in accordance with and pursuant to the timeline set forth in the SOW. Within [***] of the execution and delivery of this Agreement, Client shall provide a [***] forecast of the quantities of Client Product that Client intends to order from Xxxxxx in each month (the “Forecast”) beginning with the date scheduled for commencement of Production. At the start of every [***], Client shall furnish to Xxxxxx a written [***] rolling forecast of the quantities of Product that Client intends to order from Xxxxxx during such period (“Rolling Forecast”). Such forecasts shall be non-binding, provided however that if during any [***]. The [***] of such Rolling Forecast in respect of the Product shall constitute a binding commitment for the quantities of such Product specified therein (“Firm Commitment”) and the remaining period of the Rolling Forecast shall be non-binding, good faith estimates for information purposes only, provided that (a) the initial non-binding Forecast for any period shall subject to acceptance of same by Xxxxxx and (b) Client shall not vary a subsequent Forecast for any [***] from the initial Forecast (increase or decrease) for [***] without Althea’s written consent. Xxxxxx shall have available manufacturing capacity to supply Client with quantities of Product up to [***] of the first submitted Firm Commitment. (a) On or about the [***] during the Term, Client shall submit purchase orders which specify, at a minimum, the actual number of Batches to be Produced, the number of units in each Batch and the requested delivery date for each Batch. Such purchase orders shall be submitted at least [***] prior to the first delivery date specified in the order, and shall become binding upon acceptance by Xxxxxx, provided that Xxxxxx may not reject any order other than as provided by the terms of this Agreement, including, in the event Client is not in material compliance with any of its material payment obligations as contemplated by Section 2.12, and provided that the order is consistent with the most recent accepted Forecast, including the Firm Commitment. Production for which any change order, Purchase Order or prepayment is not received or completed with at least the prescribed lead time, if agreed to by both parties, may incur an expediting fee of [***]. (b) In the event purchase orders do not provide a continuity of Production, Xxxxxx may require additional validation batches before further Production, at the validation services rates set forth in the SOW. (c) For clarity, the Firm Commitment is subject to section 7.1.
Appears in 3 contracts
Samples: Commercial Fill/Finish Services Agreement (Avedro Inc), Commercial Fill/Finish Services Agreement (Avedro Inc), Commercial Fill/Finish Services Agreement (Avedro Inc)
Production, Forecasts & Orders. Xxxxxx shall commence Production (a) On or before the first (1st) day of Client Product in accordance with each calendar month following validation, and pursuant at least [ * ] days prior to the timeline set forth in the SOW. Within [***] of the execution and delivery of this Agreementfirst Fill Date, Client shall provide furnish to Xxxxxx a [***[ * ] rolling forecast of the quantities of Client Product that Client intends to order from Xxxxxx in each month (the “Forecast”) beginning with the date scheduled for commencement of Production. At the start of every [***], Client shall furnish to Xxxxxx a written [***] rolling forecast of the quantities of Product that Client intends to order from Xxxxxx during such period (“Rolling Forecast”). Such forecasts shall be non-binding, provided however that if during any [***]. The [***[ * ] of such Rolling Forecast in respect of the Product shall constitute a firm and binding commitment for to order the quantities Batches of such Client Product specified therein (“Firm CommitmentBinding Forecast”) during such [ * ] period, and a binding commitment on Xxxxxx to supply such Batches, and the remaining period following [ * ] of the Rolling Forecast shall be non-binding, good faith estimates for information purposes only, provided estimates. Any Binding Forecast month that (a) exceeds [ * ] of the initial last non-binding forecast for such month under the Rolling Forecast, or any non-binding part of the Rolling Forecast for any period shall subject to acceptance of same that exceeds Dedicated Capacity, may be rejected by Xxxxxx and within [ * ] business days of receipt. If not rejected, such forecasts will become part of the Binding Forecast when they roll into the Binding Forecast.
(b) Client shall not vary a subsequent Forecast for any [***] from the initial Forecast (increase or decrease) for [***] without Althea’s written consent. Xxxxxx shall have available manufacturing capacity time to supply Client with quantities of Product up to [***] of the first submitted Firm Commitment.
(a) On or about the [***] during the Term, Client shall time submit purchase orders which against the Binding Forecast that specify, at a minimum, the actual number of Batches to be Produced, the number of units in process scale for each Batch and the requested delivery date Fill Date (defined below) for each Batch. Such purchase orders shall be submitted at least [***[ * ] days prior to the first delivery earliest date specified for completion of the fill step for any Batch in the orderorder (“Fill Date”), and shall become binding upon acceptance by Xxxxxx. Except as otherwise provided herein, provided that Xxxxxx may only reject purchase orders that are not reject any order other than as provided by the terms of in compliance with this Agreement, including, in the event Client is not in material compliance with any of its material payment obligations as contemplated by Section 2.12, and provided that the order is consistent with the most recent accepted Forecast, including the Firm CommitmentBinding Forecast. Xxxxxx shall notify Client of acceptance or rejection of a purchase order within [ * ] business days of receipt. Production for which any signed agreement(s), change order, Purchase Order or prepayment is not received or completed with at least the above-prescribed lead time, if agreed to by both partiesXxxxxx, may shall incur an a minimum expediting fee of [***[ * ].
(b) In the event . Xxxxxx agrees to accept and fill Client’s purchase orders to the extent they (i) do not provide a continuity exceed [ * ] of Productionthe last non-binding Rolling Forecast for the order(s) and date(s) in question, using Dedicated Capacity, or (ii) otherwise fall within and conform to the Binding Forecast. Revance may place purchase orders in excess of this amount, and Xxxxxx may require additional validation batches before further Productionshall use commercially reasonable efforts, at the validation services rates set forth in the SOWbut shall not be obligated, to accept and fill such orders.
(c) For clarityXxxxxx shall maintain and make available the Dedicated Capacity to meet purchase orders placed by Client pursuant to the terms of this Agreement, and Xxxxxx will not utilize the Firm Commitment is subject Facility’s high-potent product line for any other customer at such times and in such manner that would make such Dedicated Capacity unavailable to section 7.1Client for Production to meet Fill Dates, including but not limited to rescheduling or delaying Client’s orders submitted in accordance with this Agreement due to orders from other customers.
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Samples: Technology Transfer, Validation and Commercial Fill/Finish Services Agreement (Revance Therapeutics, Inc.), Technology Transfer, Validation and Commercial Fill/Finish Services Agreement (Revance Therapeutics, Inc.)