Forecasts and Orders. (a) Not later than six (6) months following submission of the MAA or other applicable regulatory filing, Nycomed shall provide Acusphere with the Updated Unit Forecast. The first [CONFIDENTIAL TREATMENT REQUESTED] /*/ of such forecast shall be considered a Binding Purchase Order. Thereafter Nycomed shall provide Acusphere a rolling [CONFIDENTIAL TREATMENT REQUESTED] /*/ forecast of its purchase requirements of Product, and shall update same on a monthly basis. The first [CONFIDENTIAL TREATMENT REQUESTED] /*/ of each rolling forecast will be binding orders to purchase. The [CONFIDENTIAL TREATMENT REQUESTED] /*/ may be reduced from the previous forecast by no more than [CONFIDENTIAL TREATMENT REQUESTED] /*/ percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%) per month until fixed by the subsequent forecast; provided that the aggregate reduction from the quantity set forth in the previous forecast for such [CONFIDENTIAL TREATMENT REQUESTED] /*/ period shall not exceed [CONFIDENTIAL TREATMENT REQUESTED] /*/) percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%) in aggregate during that [CONFIDENTIAL TREATMENT REQUESTED] /*/ period. For the avoidance of doubt, the rolling forecast provided for in this paragraph does not affect the Parties' obligations under Section 6.05 or 6.06, which are governed by the Updated Unit Forecast. The initial rolling forecast provided under this paragraph shall constitute the Updated Unit Forecast for purposes of Article VI of this Agreement and shall not provide for quantities of less than [CONFIDENTIAL TREATMENT REQUESTED] /*/% of or more than [CONFIDENTIAL TREATMENT REQUESTED] /*/% of the quantities shown in the initial Unit Forecast. To the extent that the Updated Unit Forecast does not provide, for any month, for quantities above the amount shown in the initial Unit Forecast, Nycomed shall be given supply priority over Acusphere (including any customers of Acusphere) for orders for such month up to [CONFIDENTIAL TREATMENT REQUESTED] /*/% of the amount shown on the initial Unit Forecast. In addition, Nycomed shall have the right to place orders above such unit forecasts, and Acusphere shall use all commercially reasonable efforts to accommodate such orders but shall not be obligated to give such orders priority over the orders of Acusphere or any customers of Acusphere, except to the extent set forth in Section 6.05. (b) Notwithstanding the foregoing, after the [CONFIDENTIAL TREATMENT REQUESTED] /*/ orders shown in the Updated Unit Forecast have been Manufactured by Acusphere, Nycomed may, by notice to Acusphere delivered no later than [CONFIDENTIAL TREATMENT REQUESTED] /*/ after submission of the MAA or other applicable regulatory filing, suspend (or be relieved of, in the event that Governmental Approval is not obtained), its obligation to supply rolling forecasts and binding orders (and Acusphere's obligation to provide Product) until further notice, for a period of up to [CONFIDENTIAL TREATMENT REQUESTED] /*/. Acusphere shall not be responsible for any subsequent Failure to Supply occurring as a result of such suspension, and no such Failure to Supply shall trigger any of the rights of Nycomed provided pursuant to Section 6.06 hereof. (c) Purchase orders shall be given on a non-cancelable basis at least [CONFIDENTIAL TREATMENT REQUESTED] /*/ prior to the proposed shipment date (hereinafter referred to as "Binding Purchase Orders"). Acusphere shall confirm the shipment instructions and delivery times for such Binding Purchase Order to Nycomed or as otherwise directed by Nycomed. Acusphere shall be obligated to accept Binding Purchase Orders with respect to any month only to the extent provided in Section 6.05, but, subject to Section 6.05, Acusphere shall use all reasonable efforts to accept and fill any Purchase Orders which provide lead time of at least [CONFIDENTIAL TREATMENT REQUESTED] /*/, although Acusphere shall not be obligated to do so. Binding Purchase Orders shall specify any special quality requirements for any of the Jurisdictions in the Territory. If there is any conflict between the terms of a Binding Purchase Order and the terms of this Agreement, the terms of this Agreement shall govern, unless Acusphere and Nycomed have otherwise expressly agreed in writing.
Appears in 2 contracts
Sources: Collaboration, License and Supply Agreement (Acusphere Inc), Collaboration, License and Supply Agreement (Acusphere Inc)
Forecasts and Orders. (a) Not 4.1 Beginning no later than six (6) months following submission Months prior to placing its initial Purchase Order for Product (it being understood that a forecast for a Calendar Quarter may be zero), prior to the first day of the MAA or other applicable regulatory filingeach calendar quarter (beginning each 1st January, Nycomed 1st April, 1st July and 1st October and each referred to herein as a “Calendar Quarter”), CLEARSIDE BIOMEDICAL shall provide Acusphere GERRESHEIMER with a rolling forecast schedule of its projected orders for the Updated Unit ForecastProducts for at least the following four (4) Calendar Quarters (“Forecast Schedule”). The first [CONFIDENTIAL TREATMENT REQUESTED] /*/ of such forecast shall be considered a Binding Purchase Order. Thereafter Nycomed shall provide Acusphere a rolling [CONFIDENTIAL TREATMENT REQUESTED] /*/ forecast of its purchase requirements of Product, and shall update same on a monthly basis. The first [CONFIDENTIAL TREATMENT REQUESTED] /*/ of each rolling initial forecast will be binding provided by July 1, 2018 and is expected to reflect projected orders of between [***] units of Product for the following (4) Calendar Quarters. Beginning with the first Forecast Schedule submitted after the one year anniversary of the first commercial sale of the Product to purchasea Third Party (the “Commercial Launch Anniversary”), with CLEARSIDE BIOMEDICAL to notify GERRESHEIMER forthwith in writing of the date of the Commercial Launch. The Subject to Clause 4.4, CLEARSIDE BIOMEDICAL can only vary the forecast amounts for the second Calendar Quarter of a Forecast Schedule in the next subsequent Forecast Schedule by +/- [CONFIDENTIAL TREATMENT REQUESTED***], and can only vary the forecast amounts for the third Calendar Quarter of a Forecast Schedule in the next subsequent Forecast Schedule by +/- [***]. If CLEARSIDE BIOMEDICAL desires to vary the forecasted amounts by an additional [***] /*/ may be reduced from up to [***] or up to [***] respectively, then (i) in case of an increase, GERRESHEIMER agrees to notify Buyer within five (5) Business Days after receipt of such request, whether the previous forecast by no more than [CONFIDENTIAL TREATMENT REQUESTED] /*/ percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%) per month until fixed by the subsequent forecast; provided that the aggregate reduction from the quantity ordered additional quantities of Products set forth in the previous forecast for request are exceeding the Sprint Capacity and whether such [CONFIDENTIAL TREATMENT REQUESTED] /*/ period exceeding quantities can be delivered or not. In any event GERRESHEIMER will use reasonable efforts to fulfill this additional demand. In the event such excess quantities of Product directly results in additional costs, such costs shall be documented by GERRESHEIMER and the Parties shall discuss in good faith such costs and what part thereof CLEARSIDE BIOMEDICAL may need to reimburse before any such costs are incurred and/or committed. If GERRESHEIMER, despite using reasonable efforts, cannot meet such excess quantities, the failure to supply the excess quantities shall not exceed [CONFIDENTIAL TREATMENT REQUESTED] /*/) percent be regarded as a Failure to Supply; or ([CONFIDENTIAL TREATMENT REQUESTED] /*/%ii) in aggregate during that [CONFIDENTIAL TREATMENT REQUESTED] /*/ periodcase of a decrease, if such decrease directly results in additional costs, such costs shall be documented by GERRESHEIMER and the CLEARSIDE BIOMEDICAL shall reimburse to GERRESHEIMER all such documented costs. For the avoidance of doubt, the rolling maximum quantities of Products to be supplied by GERRESHEIMER during any six (6) Month period prior to the Commercial CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Launch Anniversary shall be [***] units of Product and GERRESHEIMER shall be under no obligation whatsoever to supply any quantities of Product beyond that amount.
4.2 In addition to the Forecast Schedule, prior to the 1st September of each Year after the commencement of the issuance of Forecast Schedules, CLEARSIDE BIOMEDICAL shall provide on an annual basis a two (2) Year non-binding forecast provided of projected orders for the Products to be used by GERRESHEIMER solely for planning purposes.
4.3 The Products detailed in this paragraph the first Calendar Quarter of each Forecast Schedule (“Firm Order”) will be binding on both Parties. CLEARSIDE BIOMEDICAL shall issue purchase orders against each Firm Order (each a “Purchase Order”), which Purchase Order shall include the requested delivery dates. GERRESHEIMER shall respond to each Purchase Order received from CLEARSIDE BIOMEDICAL within ten (10) Business Days of receipt. The response of GERRESHEIMER shall include confirmation of the delivery dates; PROVIDED, HOWEVER, that GERRESHEIMER may not reject any quantities forecasted in a Firm Order or any delivery date that is more than thirty (30) days from the date the applicable Purchase Order is submitted. GERRESHEIMER’s failure to reject any portion of a Purchase Order within the applicable ten (10) Business Day period shall be deemed to be GERRESHEIMER’s acceptance thereof. In the event that either Party requires amendments to the quantities ordered, the timing of production and/or delivery, the relevant planning personnel from both Parties shall within ten (10) Business Days of receipt of a Forecast Schedule, Firm Order or Purchase Order discuss in good faith and agree amendments to the Forecast Schedule, Firm Order or Purchase Order.
4.4 CLEARSIDE BIOMEDICAL and/or its Affiliates shall use commercially reasonable endeavours not to, at any one time, collectively place Firm Orders at a level that would require an aggregate capacity at GERRESHEIMER greater than the maximum manufacturing capacity of the Manufacturing Site as set forth in the applicable Product Schedule (“Sprint Capacity”) and GERRESHEIMER shall not be obliged to supply Products in excess of the Sprint Capacity. In the event that the aggregate CLEARSIDE BIOMEDICAL demand is greater than the Sprint Capacity CLEARSIDE BIOMEDICAL shall promptly instruct GERRESHEIMER the order of preference for the deliveries.
4.5 It is understood that the remaining three (3) Calendar Quarters of the Forecast Schedule constitutes an estimate of the future Product requirement of CLEARSIDE BIOMEDICAL and its Affiliates and does not affect constitute a binding commitment by CLEARSIDE BIOMEDICAL or its Affiliates to order or purchase such Product.
4.6 For certain long lead time materials, as defined in good faith between the Parties' obligations under Section 6.05 or 6.06, which requires GERRESHEIMER to place orders with a minimum lead time longer than three (3) Months in advance of manufacturing, GERRESHEIMER will be entitled to place those orders based on the projections set forth in a Forecast CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Schedule, and CLEARSIDE BIOMEDICAL agrees to pay for any such Materials which are governed not used in Firm Orders of Products placed by CLEARSIDE BIOMEDICAL and/or its Affiliates and cannot otherwise be used by GERRESHEIMER.
4.7 CLEARSIDE BIOMEDICAL may from time to time provide GERRESHEIMER with individual purchase orders for Products in addition to the Updated Unit Forecastquantities set forth in Firm Orders. GERRESHEIMER shall respond to each such individual purchase order received from CLEARSIDE BIOMEDICAL or an Affiliate of CLEARSIDE BIOMEDICAL within ten (10) Business Days of receipt. The initial rolling forecast provided response shall include confirmation or not of the Delivery dates and quantity as set out in such individual purchase order. GERRESHEIMER’s failure to reject any portion of such Purchase Order within the applicable ten (10) Business Day period shall be deemed to be GERRESHEIMER’s acceptance thereof.
4.8 If a CLEARSIDE BIOMEDICAL Affiliate desires to purchase the Product from GERRESHEIMER under this paragraph shall constitute the Updated Unit Forecast for purposes of Article VI terms of this Agreement the Parties will consider the appropriate contractual mechanisms for the CLEARSIDE BIOMEDICAL Affiliate to receive Product from GERRESHEIMER or its Affiliates (as the case may be) and shall not provide for quantities of less than [CONFIDENTIAL TREATMENT REQUESTED] /*/% of or more than [CONFIDENTIAL TREATMENT REQUESTED] /*/% of the quantities shown in the initial Unit Forecast. To the extent that the Updated Unit Forecast does not provide, for any month, for quantities above the amount shown in the initial Unit Forecast, Nycomed shall be given supply priority over Acusphere (including any customers of Acusphere) for orders for such month up to [CONFIDENTIAL TREATMENT REQUESTED] /*/% of the amount shown on the initial Unit Forecast. In addition, Nycomed shall have the right to place orders above such unit forecasts, and Acusphere shall use all commercially reasonable efforts to accommodate such orders but shall not be obligated to give such orders priority over the orders of Acusphere or any customers of Acusphere, except to the extent set forth in Section 6.05.
(b) Notwithstanding the foregoing, after the [CONFIDENTIAL TREATMENT REQUESTED] /*/ orders shown in the Updated Unit Forecast have been Manufactured by Acusphere, Nycomed may, by notice to Acusphere delivered no later than [CONFIDENTIAL TREATMENT REQUESTED] /*/ after submission of the MAA or other applicable regulatory filing, suspend (or be relieved of, in the event that Governmental Approval is not obtained), its obligation to supply rolling forecasts and binding orders (and Acusphere's obligation to provide Product) until further notice, for a period of up to [CONFIDENTIAL TREATMENT REQUESTED] /*/. Acusphere shall not be responsible for any subsequent Failure to Supply occurring as a result of such suspension, and no such Failure to Supply shall trigger any of the rights of Nycomed provided pursuant to Section 6.06 hereof.
(c) Purchase orders shall be given on a non-cancelable basis at least [CONFIDENTIAL TREATMENT REQUESTED] /*/ prior to the proposed shipment date (hereinafter referred to as "Binding Purchase Orders"). Acusphere shall confirm the shipment instructions and delivery times for such Binding Purchase Order to Nycomed or as otherwise directed by Nycomed. Acusphere shall be obligated to accept Binding Purchase Orders with respect to any month only to the extent provided in Section 6.05, but, subject to Section 6.05, Acusphere shall use all reasonable efforts to accept and fill any Purchase Orders which provide lead time of at least [CONFIDENTIAL TREATMENT REQUESTED] /*/, although Acusphere shall not be obligated to do so. Binding Purchase Orders shall specify any special quality requirements for any of the Jurisdictions in the Territory. If there is any conflict between the terms of a Binding Purchase Order and benefit from the terms of this Agreement, taking into account the terms CLEARSIDE BIOMEDICAL Affiliate may need to enter into separate legal agreements with GERRESHEIMER. For the avoidance of this Agreement doubt, before the aforementioned contractual mechanism has been agreed by the Parties, GERRESHEIMER shall governnot be obliged to sell (and/or deliver) any Products to CLEARSIDE BIOMEDICAL Affiliates or fulfil or accept purchase orders from CLEARSIDE BIOMEDICAL Affiliates. GERRESHEIMER shall confirm promptly to CLEARSIDE BIOMEDICAL whether such CLEARSIDE BIOMEDICAL Affiliate is covered by GERRESHEIMER’s trade credit insurance. If such COMPANY Affiliate is not covered by GERRESHEIMERs trade credit insurance, unless Acusphere and Nycomed have otherwise expressly agreed in writing.then GERRESHEIMER shall only provide such CLEARSIDE BIOMEDICAL Affiliate with the named Product upon receipt of a payment security from CLEARSIDE BIOMEDICAL by means of a payment guarantee of CLEARSIDE BIOMEDICAL or a bank guarantee of an internationally business bank rated with triple B.
Appears in 1 contract
Forecasts and Orders. (a) Not later than six Every ninety (690) months following submission days during the Term, Can-Am shall provide AMG with (i) a good faith forecast (a "Forecast") of its anticipated purchases of M/C Lancets during each of the MAA or other applicable regulatory filingfour (4) three-month periods ("Quarters") following the date of the forecast (the "Forecast Date"), Nycomed shall provide Acusphere and (ii) a binding purchase order ("Purchase Order") for M/C Lancets to be shipped from time to time in accordance with the Updated Unit Forecastprovisions of this Agreement. The Can-Am agrees to purchase from AMG (A) no less than 100% of the M/C Lancets that it forecasted that it would purchase during the first [CONFIDENTIAL TREATMENT REQUESTED] /*/ of such forecast shall be considered a Binding Purchase Order. Thereafter Nycomed shall provide Acusphere a rolling [CONFIDENTIAL TREATMENT REQUESTED] /*/ forecast two Quarters of its purchase requirements of Productmost recent Forecast, and shall update same on a monthly basis. The first [CONFIDENTIAL TREATMENT REQUESTED] /*/ of each rolling forecast will be binding orders to purchase. The [CONFIDENTIAL TREATMENT REQUESTED] /*/ may be reduced from the previous forecast by (B) no more than [CONFIDENTIAL TREATMENT REQUESTED] /*/ percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%) per month until fixed by the subsequent forecast; provided that the aggregate reduction from the quantity set forth in the previous forecast for such [CONFIDENTIAL TREATMENT REQUESTED] /*/ period shall not exceed [CONFIDENTIAL TREATMENT REQUESTED] /*/) percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%) in aggregate during that [CONFIDENTIAL TREATMENT REQUESTED] /*/ period. For the avoidance of doubt, the rolling forecast provided for in this paragraph does not affect the Parties' obligations under Section 6.05 or 6.06, which are governed by the Updated Unit Forecast. The initial rolling forecast provided under this paragraph shall constitute the Updated Unit Forecast for purposes of Article VI of this Agreement and shall not provide for quantities of less than [CONFIDENTIAL TREATMENT REQUESTED] /*/% of or more than [CONFIDENTIAL TREATMENT REQUESTED] /*/% 85% of the quantities shown in M/C Lancets that it forecasted that it would purchase during the initial Unit third and fourth Quarters of its most recent Forecast. To the extent that the Updated Unit Forecast does not provide, for any month, for quantities above the amount shown in the initial Unit Forecast, Nycomed shall be given supply priority over Acusphere (including any customers of Acusphere) for orders for such month up to [CONFIDENTIAL TREATMENT REQUESTED] /*/% of the amount shown on the initial Unit Forecast. In addition, Nycomed shall have the right to place orders above such unit forecasts, and Acusphere shall use all commercially reasonable efforts to accommodate such orders but shall not be obligated to give such orders priority over the orders of Acusphere or any customers of Acusphere, except to the extent set forth in Section 6.05.
(b) Notwithstanding Can-Am shall authorize shipment of M/C Lancets by issuing a Purchase Order to AMG, and AMG shall cause M/C Lancets to be shipped in accordance with the foregoing, after the [CONFIDENTIAL TREATMENT REQUESTED] /*/ orders shown Purchase Order. Each Purchase Order shall be in the Updated Unit Forecast have been Manufactured by Acusphereform of Exhibit A hereto. Each Purchase Order shall identify (i) the quantity and other characteristics (including pack size, Nycomed maypackaging information, by notice gauge, SKU and color) of M/C Lancets to Acusphere be delivered no later than [CONFIDENTIAL TREATMENT REQUESTED] /*/ after submission of and (ii) the MAA or other applicable regulatory filingrequired delivery date, suspend (or be relieved of, in the event that Governmental Approval is not obtained), its obligation to supply rolling forecasts and binding orders (and Acusphere's obligation to provide Product) until further notice, for a period of up to [CONFIDENTIAL TREATMENT REQUESTED] /*/. Acusphere which date shall not be responsible for any subsequent Failure to Supply occurring as a result of such suspension, and no such Failure to Supply shall trigger any less than ten (10) days after the date of the rights of Nycomed provided pursuant to Section 6.06 hereofrelevant Purchase Order.
(c) AMG shall promptly acknowledge each Purchase orders Order by signing and returning to Can-Am the acknowledgment copy of each Purchase Order promptly after its receipt. AMG shall be given on deemed to have accepted a non-cancelable basis at least [CONFIDENTIAL TREATMENT REQUESTED] /*/ prior to the proposed shipment date (hereinafter referred to as "Binding Purchase Orders"). Acusphere shall confirm the shipment instructions and delivery times for such Binding Purchase Order unless it delivers to Nycomed or as otherwise directed by Nycomed. Acusphere shall be obligated Can-Am a written notice objecting to accept Binding such Purchase Orders with respect to any month only to Order within five (5) business days after receipt of such Purchase Order.
(d) In the extent provided in Section 6.05, but, subject to Section 6.05, Acusphere shall use all reasonable efforts to accept and fill any Purchase Orders which provide lead time event of at least [CONFIDENTIAL TREATMENT REQUESTED] /*/, although Acusphere shall not be obligated to do so. Binding Purchase Orders shall specify any special quality requirements for any of the Jurisdictions in the Territory. If there is any conflict between the terms and conditions of a Binding Purchase Order this Agreement and the terms and conditions of this AgreementCan-Am's Purchase Order or any other document, the terms and conditions of this Agreement shall govern, unless Acusphere be controlling.
(e) The parties hereto may agree to modify the procedures for ordering and Nycomed have otherwise expressly agreed in writingdelivering M/C Lancets hereunder.
Appears in 1 contract
Sources: Supply Agreement (Selfcare Inc)