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EXTRACORPOREAL DISPOSABLES DISTRIBUTION AGREEMENT

Distribution Agreement

EXTRACORPOREAL DISPOSABLES DISTRIBUTION AGREEMENT | Document Parties: NXSTAGE MEDICAL, INC. | 439 South Union | Gambro Renal Products, Inc | Medisystems Corporation You are currently viewing:
This Distribution Agreement involves

NXSTAGE MEDICAL, INC. | 439 South Union | Gambro Renal Products, Inc | Medisystems Corporation

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Title: EXTRACORPOREAL DISPOSABLES DISTRIBUTION AGREEMENT
Governing Law: Delaware     Date: 8/7/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

EXTRACORPOREAL DISPOSABLES DISTRIBUTION AGREEMENT, Parties: nxstage medical  inc. , 439 south union , gambro renal products  inc , medisystems corporation
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Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisk denote omissions.

Exhibit 10.46

EXTRACORPOREAL DISPOSABLES DISTRIBUTION AGREEMENT

               This Agreement, dated as of June 15, 2009 (the “Effective Date”), is between Medisystems Corporation, a Washington corporation with offices at 439 South Union Street, 5 th Floor, Lawrence, Massachusetts 10843 (together with its affiliates, “MDS”) and Gambro Renal Products, Inc., a Colorado corporation with offices at 14143 Denver West Parkway, Lakewood, Colorado 80401 (together with its affiliates, “Gambro”). MDS and Gambro shall each be referred to herein as a “ Party ” and collectively as the “ Parties ”.

               In consideration of the mutual promises made herein and other good and valuable consideration, the receipt of which is hereby acknowledged, the Parties hereto agree as follows:

     1.0 BACKGROUND

          1.1 The following are examples of certain disposable medical devices useful in dialysis therapies (collectively, the “Products”):

                    Non-cartridge blood tubing sets designed for use with Fresenius dialysis monitors (“BTL”).

          MDS designs and supplies certain Products under Specifications (as hereinafter defined) including MDS labeling which MDS controls and currently has produced by subsidiaries or contract manufacturers as set forth in Exhibit B (“MDS Products”). Gambro wishes to purchase certain MDS Products for resale to DaVita (as defined below) and certain of its other dialysis customers in certain countries of the world as listed in Exhibit A (the “Territory”).

     2.0 TERM OF AGREEMENT

          2.1 The term (including any extensions, the “Term”) of this Agreement shall be for a five (5) year period beginning on the Effective Date of this Agreement. The Agreement shall terminate at the end of the Term, unless the Parties agree on provisions for an extension of the Term not less than six (6) months prior to the date on which this Agreement would otherwise terminate.

     3.0 MDS PRODUCTS

          3.1 The MDS Products that Gambro wishes to purchase pursuant to this Agreement are listed in Exhibit B as “MDS BTL”, as such Exhibit B may be amended from time to time by mutual agreement of the Parties. The codes of the MDS Products that are the subject of this Agreement are hereafter referred to as “Codes”. The Codes shall meet specifications as set forth in Exhibit C, or as such specifications, including labeling, may be modified from time to time pursuant to Sections 9.1, 9.2 and 9.3 (the “Specifications”), provided that such modifications are agreed upon in amendments to Exhibit C signed pursuant to Section 18.2 hereof.

          3.2 MDS reserves the right, at its sole discretion, to incorporate clinical use enhancements or developments in existing Codes of the MDS Products or to supply existing Codes from alternate manufacturing sites or manufacturers even if MDS designates them with a different Code suffix, provided that (i) no price increase is requested by MDS, (ii) the change does not alter the Specifications (other than the Code suffix), and (iii) the change does not, in MDS’ reasonable opinion, materially change the manufacturing process for the Codes or materially change the Codes. If any of the preceding clauses are not satisfied, Gambro shall not be required to accept such change, unless, in the reasonable opinion of Gambro, the change does not adversely affect the Code’s conformance to the Code’s material performance characteristics.

     4.0 PURCHASES AND ORDERS

          4.1 Subject to the terms and conditions of this Agreement, MDS shall sell the Codes listed in Exhibit B to Gambro and Gambro shall purchase the Codes listed in Exhibit B for use or resale by Gambro only in the Territory.

          4.2 “Contract Year” shall mean for the first Contract Year, that period of time commencing on the Effective Date of this Agreement and ending on December 31, 2009. Thereafter, each Contract Year shall be from January 1 through December 31 of each calendar year during the Term of this Agreement, except that the last Contract Year

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shall end on the termination or expiration date, if different than December 31.

          4.3 During the Exclusive Period (as defined below), Gambro hereby agrees to sell, directly or indirectly (including without limitation to include sales through agents, representatives or distributors) to DaVita Inc., DaVita affiliated entities, DaVita dialysis clinics, DaVita management contract clinics, and clinics or entities jointly owned by DaVita or DaVita affiliates (collectively, “DaVita”) BTL sourced only and exclusively from among MDS BTL listed in Exhibit B (the “Exclusive Products”). During the Exclusive Period, MDS hereby agrees not to sell, directly or indirectly (including without limitation to include sales through agents, representatives or distributors) MDS BTL to DaVita; provided, however, that this obligation shall expire prior to the expiration of the Term or earlier termination of this Agreement in the event DaVita (i) ceases to have any material contractual ongoing purchase obligations with respect to BTL to Gambro which can be satisfied through the purchase of MDS BTL from Gambro, or (ii) ceases to purchase at least [**] percent ([**]%) of its BTL requirements (such requirements including, without limitation, all of DaVita’s purchase, use, and/or inventory requirements for BTL (hereinafter, “BTL Requirements”)) from Gambro in the form of MDS BTL (as measured by Calendar Quarter, or at the reasonable request of MDS, on a rolling [**] month basis),it being understood that Gambro shall not be deemed to be in breach of this requirement, and MDS shall not have the right to immediately terminate this Agreement, if such failure to satisfy such requirement is due to (i) DaVita’s purchases of MDS BTL from MDS, Henry Schein or other third party MDS customers, (ii) MDS’ failure to deliver conforming MDS BTL pursuant to accepted Gambro Delivery Orders, or (iii) a material increase in the percentage of DaVita joint venture or managed clinics, to the extent such clinics are not obligated to purchase at least [**]% of their BTL requirements from Gambro under any agreement with DaVita; provided that during the Term Gambro shall not enter into any agreement or amendment with DaVita which imposes a lower purchase requirement for DaVita with respect to BTL to be purchased from Gambro in aggregate or with respect to any type of DaVita dialysis clinic or facility, or which would impair in any way DaVita’s obligation to buy MDS BTL from Gambro hereunder. Notwithstanding the foregoing, Gambro shall be deemed to be in breach of this requirement, and MDS shall have the right to immediately terminate this Agreement, if in any [**] consecutive Calendar Quarters (or at the reasonable request of MDS, [**] consecutive rolling [**] month periods) during the Exclusive Period DaVita purchases less than [**] percent ([**]%) of its BTL Requirements from Gambro in the form of MDS BTL, except if such failure occurs due to DaVita’s purchases of MDS BTL from MDS, Henry Schein or other third party MDS customers, or due to MDS failure to deliver conforming MDS BTL pursuant to accepted Gambro Delivery Orders. Gambro agrees that during the Exclusive Period, MDS shall not be deemed to be in breach of its exclusivity obligations under this Section 4.3 with respect to MDS BTL sold to DaVita, and that Gambro shall not have the right to immediately terminate this Agreement, if (X) sales to DaVita of MDS BTL made by third party customers of MDS do not in any given month exceed [**] percent ([**]%) of DaVita’s BTL Requirements (such sales to be counted as sales by Gambro for purposes of determining compliance with the [**]% requirement set forth herein), (Y) MDS agrees to use commercially reasonable efforts to stop such third party sales promptly upon receiving notice thereof from Gambro, and (Z) MDS agrees to use commercially reasonable efforts to ensure that, from and after the start of the Exclusive Period, MDS’ agreements with third party customers (including distributors) prohibit sales of MDS BTL to DaVita. If such sales exceed [**] percent ([**]%) of DaVita’s BTL Requirements for [**] consecutive months following the delivery of written notice thereof to MDS, Gambro shall have the right to terminate this Agreement upon thirty (30) days notice. For purposes hereof, the “Exclusive Period” shall mean the period of time commencing on [**] and continuing through the expiration of the Term, except as provided herein (it being understood that MDS shall use commercially reasonable efforts to have the Exclusive Period commence prior to [**]). In the event [**], Gambro agrees that the Exclusive Period shall not commence until MDS is [**], it being understood that MDS shall endeavor in good faith to ensure that the Excusive Period can commence on [**], and further that in any event that the Exclusive Period shall start on or before [**]. Gambro further agrees that the Exclusive Period shall not commence until Gambro has confirmed to MDS that (i) Gambro has sufficient warehouse space and inventory of MDS BTL (consistent with the initial Delivery Orders set forth Section 4.5 below) to support its obligations hereunder and (ii) DaVita shall purchase MDS BTL from Gambro pursuant hereto (provided that in any event Gambro warrants that DaVita shall commence purchasing at least [**] percent ([**]%) of its BTL Requirements from Gambro in the form of MDS BTL on or before [**], it being understood that Gambro shall not be deemed to be in breach of this requirement and that MDS shall not have the right to immediately terminate this Agreement if the reason for DaVita’s failure to purchase [**]% of its BTL requirements from Gambro in the form of MDS BTL is due to (i) DaVita’s purchases of MDS BTL from MDS, Henry Schein or other third party MDS customers, or (ii) MDS failure to deliver conforming MDS BTL pursuant to accepted Gambro Delivery Orders). MDS agrees that Gambro may commence non-exclusive sales of MDS BTL to DaVita as soon as practical after receipt of the MDS BTL deliveries

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set forth in Section 4.5. Gambro understands and agrees that Henry Schein may continue to sell to DaVita during the Exclusive Period any inventories it may have of MDS BTL supplied by MDS prior to the start of the Exclusive Period pursuant to Henry Schein’s contract with DaVita; provided that MDS agrees that it will not accept purchase orders for MDS BTL from Henry Schein for sale to DaVita after [**]. Gambro and MDS shall endeavor in good faith to agree on the most suitable transition to the Exclusive Period, including but not limited to providing Gambro the option, subject to Henry Schein’s consent, to purchase any inventory in Henry Schein’s possession as of [**]. Gambro represents that DaVita is obligated, during the Term of this Agreement, to purchase at least [**] percent ([**]%) of its BTL requirements from Gambro, and that Gambro may satisfy this requirement through the sale to DaVita of the MDS BTL to be sold hereunder. Gambro further represents that it shall use all commercially reasonable efforts to ensure that DaVita satisfies this obligation.

          4.4 This Agreement does not confer any additional distribution rights to Gambro. The Parties agree to evaluate, in good faith, any opportunity to expand or modify the Territory as such opportunities materialize, provided (i) that any exclusivity agreed by the Parties shall be deemed irreversible for the remaining term of the Agreement, except as otherwise provided herein (including, without limitation, as provided in Section 4.3 hereof), and (ii) that both MDS and Gambro will have the right to suggest such expansion or modification. The Parties further agree to undertake such evaluation in a manner which is not unreasonably conditioned or delayed.

          4.5 On or before the [**] day of each month (or if the [**] falls on a non-business day, the day immediately thereafter which is a business day) during the Term of this Agreement (the “Order Date”), Gambro will provide MDS with one or more non-cancellable delivery order(s) (a “Delivery Order” or “Delivery Orders”) for the MDS Products. All Delivery Orders provided on or before the [**] day of a month (or the next succeeding business day) shall be deemed to have the same Order Date; any Delivery Order provided to MDS after the [**] day of the month (or the next succeeding business day) shall be deemed to have an Order Date on the [**] day of the subsequent month (or the next succeeding business day of that subsequent month). The requested delivery date (“Due Date”) provided by Gambro on each Delivery Order having the same Order Date shall be not earlier than [**] days after such Order Date. Unless MDS has otherwise notified Gambro within [**] business days of receipt from Gambro, MDS shall be deemed to have accepted the Delivery Order, including Due Date. Each Gambro Delivery Order for delivery to each DDP Location (as hereinafter defined) shall conform to the per Code or per MDS Product quantity minimums and multiples stated in Exhibit B. Notwithstanding the foregoing, within [**] business days of the Effective Date, Gambro shall place Delivery Orders for [**] MDS BTL for delivery in [**], and [**] MDS BTL for delivery in [**] (such Delivery Orders collectively hereinafter referred to as the “Initial Orders”), provided that, in selling these volumes, Gambro will not be bound by the exclusivity obligations set forth in Section 4.3 above until the commencement of the Exclusive Period. MDS agrees that Gambro shall have no obligation to place Delivery Orders, other than Initial Orders, pursuant to this Section 4.5 until the commencement of the Exclusive Period. MDS agrees that the MDS BTL shipped to Gambro under the Initial Orders shall have at least [**] months remaining shelf life at the time of delivery to Gambro. MDS shall promptly notify Gambro in the event it anticipates any delay to the start of the Exclusive Period beyond [**] due to anticipated ongoing sales of MDS BTL from Henry Schein to DaVita, and shall discuss in good faith with Gambro alternatives for reducing Gambro’s carrying costs associated with the Initial Orders, including, without limitation, delayed payment terms on the Initial Orders or delayed delivery schedules on such orders.

          4.6 Any Delivery Orders with a common Due Date and DDP Location that cumulatively comprise less than the number of pallets required to comprise full container loads or truck loads as indicated in Exhibit B, shall be subject to freight cost premiums as quoted to Gambro by MDS at the time the Delivery Order is accepted.

          4.7 During the period commencing [**] months after the commencement of the Exclusivity Period through the expiration of the Term, and except as set forth in Section 4.8 below, MDS shall not be required to accept any Gambro Delivery Orders with a common Order Date to the extent that the aggregate quantity of Codes in any Code Group (as defined in Exhibit B) so ordered exceeds [**] percent ([**]%) of the average monthly quantity ordered of that Code Group during the immediately preceding [**] months, provided that MDS will make commercially reasonable efforts to accept such excess. If accepted, such excess quantities shall, at MDS’ option, be deemed to have an Order Date on the [**] day of the next subsequent calendar month and shall remain subject to the provisions of this Section. In such event, however, such excess amount shall count towards the [**]% limit applicable to such following Order Date; provided that MDS will make commercially reasonable efforts to supply such excess. If MDS reallocates any Gambro Delivery Orders pursuant to this Section 4.7, it shall consult with Gambro to

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determine which orders shall be reallocated to a future Order Date. During the period commencing on the start date of the Exclusivity Period through [**] months after the commencement of the Exclusivity Period, Gambro Delivery Orders with a common Order Date must be for a minimum of [**] units (it being understood that MDS shall consider in good faith Gambro Delivery Orders below this unit level during this [**] month period where such lower unit levels are due to DaVita’s inventory levels of MDS BTL purchased from Henry Schein or DaVita’s ongoing purchases of MDS BTL directly from MDS, out of Henry Schein inventories or out of the inventories of other third party MDS customers) and no more than [**] units. During the period commencing on the Effective Date through the start of the Exclusive Period, MDS shall not be required to accept any Gambro Delivery Orders other than the Initial Orders; provided that MDS will make commercially reasonable efforts to accept orders in excess of the Initial Orders.

          4.8 Notwithstanding the foregoing, during the final [**] months of this Agreement as determined in accordance with Section 2.1 hereof, MDS have no obligation to accept Gambro Delivery Orders to the extent that the aggregate quantity of Codes in any Code Group so ordered for delivery in such final [**] month period exceeds the aggregate quantities ordered by Gambro during the immediately preceding [**] months.

          4.9 By the [**] business day of each month during the Term of this Agreement, Gambro shall provide MDS with a non-binding forecast of the quantity of each Code Gambro estimates it shall place orders for during the following [**] months. These forecast figures will be e-mailed to the General Manager, Medisystems.

          4.10 By the [**] business day of each [**], Gambro shall provide its ending inventory by Code and warehouse and aggregate end user sales information by Code and warehouse for DaVita as well as for all other customers in aggregate, in each case from the previous [**] to MDS.

     5.0 SHIPMENT OF MDS PRODUCTS

          5.1 MDS will ship the MDS Products, [**] to Gambro’s warehouses in [**] (the “DDP Locations”) at the prices listed in Exhibit D. Title for MDS Products shall pass to Gambro upon delivery at the DDP Locations. MDS and Gambro may agree to add new DDP Locations in the Territory at any time provided the incremental cost for delivery to such DDP Locations shall be added to the delivery price by amendment to Exhibit D, signed pursuant to Section 18.2 hereof.

          5.2 MDS shall prepare and send by facsimile transmission or via e-mail to Gambro a packing list for each shipment of MDS Products. This shipping information will include Gambro’s specific purchase order number, item shipping quantities, and item back order information. When MDS has the necessary systems and procedures in place, the packing slip will also accompany the shipment to avoid loss of missing faxes and to reduce the chance of mismatching the paper to the shipment.

          5.3 MDS shall notify Gambro as soon as MDS becomes aware that any shipment may not be delivered on or within the period prior to the Due Date and ending [**] days after the Due Date applicable to a Delivery Order, such period being hereinafter referred to as the “Delivery Window”. Except as set forth in Section 8.1, if MDS is delinquent with Delivery Orders properly placed by Gambro and accepted by MDS in accordance with the terms of this Agreement, and as a result, to the degree that Gambro has insufficient MDS Products to ship to its customer in its customary manner and at customary prices, MDS will be responsible for incremental freight costs including all priority and cross shipping charges associated with MDS delayed order fulfillment provided that the proper documentation of such incremental charges is produced, with prior written authorization by MDS, of which such authorization shall not be unreasonably conditioned, withheld or delayed.

          5.4 Gambro shall notify MDS in writing of any claim relating to: (i) any MDS Product that is damaged or does not conform to the MDS Product Specifications at the time title to such MDS Product is transferred to Gambro, or any MDS Product packaging that is damaged at the time title to such MDS Product is transferred to Gambro, within [**] days of Gambro’s receipt of such shipment; or (ii) any shortage in quantity of any shipment of MDS Product, within [**] days of Gambro’s receipt of such shipment. In the event of rejection of such non-conforming or damaged MDS Product, any such damaged MDS Product packaging, or shortage, MDS, unless it reasonably

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disputes Gambro’s claim, shall, subject to Section 5.5 below, replace the MDS Product or make up the shortage within [**] days of receiving such notice, provided that MDS has sufficient conforming MDS Products in its inventory to do so, at no additional cost to Gambro, and shall make arrangements with Gambro for the return or destruction of any rejected MDS Product, such return shipping charges or costs of destruction to be paid by MDS. If sufficient conforming MDS Products are not available, MDS shall use commercially reasonable efforts to replace the nonconforming MDS Products with conforming MDS Products at no additional cost to Gambro as soon as possible, but in no event shall the replacement time exceed [**] days. In addition to the foregoing, in order to minimize the possibility of any inventory shortages resulting from the unavailability of sufficient conforming MDS Product, MDS agrees that it will deliver conforming MDS Product as it becomes available and will not wait until full replacement quantities are available. The provisions of this Section 5.4 apply only to claims relating to MDS Products that have not yet been shipped to customers. Returns of MDS Products that have been shipped to customers are governed by the provisions set forth in Section 11.3.

          5.5 In the event of a conflict regarding any nonconforming MDS Product which Gambro and MDS are unable to timely resolve, samples of the MDS Products shall be submitted by [**] to an independent laboratory reasonably acceptable to both Parties for testing against the Product Specifications and the test results obtained by such laboratory shall be final and binding upon the Parties. The fees and expenses of such laboratory testing shall be borne entirely by the Party against whom such laboratory’s findings are made. In the event the test results indicate that the MDS Product in question does not conform to the Product Specifications, MDS shall replace such MDS Product with conforming MDS Product at no additional cost to Gambro within [**] days after receipt of such results, provided that MDS has sufficient conforming MDS Product in its inventory to do so. If sufficient conforming MDS Product is not available, MDS shall use commercially reasonable efforts to replace the nonconforming MDS Product with conforming MDS Product at no additional cost to Gambro as soon as possible, but in no event shall the replacement time exceed [**] days. In addition to the foregoing, in order to minimize the possibility of any inventory shortages resulting from the unavailability of sufficient conforming MDS Product, MDS agrees that it will deliver conforming MDS Product as it becomes available and will not wait until full replacement quantities are available.

          5.6 Gambro accepts MDS’s standard packaging and palletizing methods as specified in Exhibit B. MDS will examine proposals to modify the palletizing methods as requested by Gambro, and provided these modifications are approved by MDS, Gambro agrees to pay any additional costs and to accept responsibility for any damage related to the new packaging methods. MDS will use reasonable best efforts to revisit its pallet size and work to conform to the Gambro rack height configurations.

     6.0 PRICES

          6.1 MDS will sell the Codes meeting the Specifications set forth in Exhibit C to Gambro, and Gambro agrees to buy the Codes from MDS at the base prices and at DDP Locations listed in Exhibit D (“Base Prices”). MDS makes no commitment to provide any Code at these Base Prices beyond [**], provided, that, any such increases shall be subject to verification by an independent third party auditor selected and engaged by Gambro, and reasonably acceptable to MDS, of the underlying cost increases. The Parties agree that any information provided to such independent third party auditor shall be treated as strictly confidential by such auditor, and shall not be disclosed to Gambro; such independent third party auditor only being authorized to verify or not verify the requested price increase and the extent to which the underlying costs are reasonably within MDS’ control. No information provided to any such independent third party auditor may be copied, reproduced or removed from MDS’s premises.

          6.2 The quantity prices listed in Exhibit D are set forth on the basis of the total quantity of Delivery Orders placed during each Contract Year for Codes. Prices include [**] DDP Gambro’s warehouse locations specified in Exhibit D.

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          6.3 It is expressly agreed that Base Prices for the Codes include [**], (“Premiums”) will be invoiced to Gambro.

          6.4 Gambro agrees to sell the MDS Products in accordance with the terms, covenants and conditions contained in this Agreement. Notwithstanding the foregoing or anything contained in this Agreement to the contrary, Gambro shall, in its sole and absolute discretion, determine the resale prices for the MDS Products.

     7.0 PAYMENT

          7.1 The terms of payment for the MDS Products purchased by Gambro under this Agreement shall be [**] days from MDS’s invoice date; provided that Gambro shall receive a [**] percent ([**]%) discount from the invoiced amount in the event payment is received by MDS on or before [**] days after the invoice date. Any amounts not paid within [**] days from the invoice date shall be subject to a service charge until paid, in an amount equal to [**]% per month. Such service charge shall be computed on the last working day of the calendar month, on a pro rata basis if applicable, for invoices [**] days old or more. In addition, if full payment including service charge is not received by MDS within [**] days from MDS’s invoice date MDS may restrict weekly sales to Gambro to a dollar amount equal to the payments received from Gambro in the previous week. If full payment is not received by MDS within [**] days of MDS’s invoice date Gambro shall be considered to be in material breach of this Agreement and subject to Section 14.1. MDS may invoice Gambro upon email notification to Gambro that Codes are available for carrier pickup at the DDP Locations listed in Exhibit D.

          7.2 All Gambro payments are to be made by either wire transfer or ACH transfer and remitted to the financial institution designated by MDS to receive such payments.

     8.0 ADDITIONAL OBLIGATIONS REGARDING DELAYED AND REPLACEMENT PRODUCTS

          8.1 MDS assumes no liability and shall not be liable to Gambro for any failure to fill or delay in filling Delivery Orders received from Gambro and accepted by MDS to the extent such failure or delay results from strikes, lockouts, or any other labor troubles, floods, fires, accidents, import or shipping delays, delays in the delivery of raw materials, parts or completed merchandise by the supplier thereof, or any cause beyond the reasonable control of or occurring without the fault of MDS. In the event of any delay caused by any of the above, MDS shall use commercially reasonable efforts to fulfill Gambro’s Delivery Orders in a timely fashion, provided, however, that in the event of a shortage of available MDS Products, whether resulting from market conditions, manufacturing constraints, FDA action against any company or otherwise, MDS will use commercially reasonable best efforts to allocate in reasonable proportion to Gambro’s market share, as compared to the total market size. MDS shall notify Gambro promptly if it anticipates any potential delay in the filling of any of Gambro’s Delivery Orders caused by any of the above.

          8.2 Notwithstanding Section 4.3, Gambro may, at its option, be relieved of its commitment to purchase the BTL listed in the Exclusive Products only from MDS and shall have the right to purchase replacement Products from other suppliers or manufactured by Gambro, in whole or in part, at Gambro’s option and at its own expense, should MDS, for the reasons specified in Section 8.1, be unable to supply Delivery Orders and such inability continues for [**] days after the first delivery date is missed; provided that Gambro, prior to exercising its option hereunder, must provide MDS written notice of its intention to exercise its option hereunder, and provide MDS the opportunity to cure such inability to supply within [**] days of receipt of Gambro’s notice thereof. Gambro agrees to work in good faith with MDS to resolve any issues associated with any inability to supply hereunder.

          8.3 Notwithstanding Section 4.3, Gambro may, at its option, be relieved of its obligations with respect to any specific Delivery Order, in whole or in part, at Gambro’s option, should a delay caused by an event described in Section 8.1 occur, if such delay is uncured within [**] days after the Delivery Window of such Delivery Order. To the extent MDS is unable to deliver within [**] days after the Delivery Window applicable to any Delivery Order MDS Products delayed by an event described in Section 8.1, Gambro may purchase replacement Products from

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other suppliers or manufactured by Gambro, in each case at its own expense, notwithstanding the obligations of Section 4.3.

          8.4 Except as set forth in Sections 4.5, 4.7, 4.8 and 8.1, if MDS is unable to deliver MDS Products during the Delivery Window applicable to an accepted Gambro Delivery Order, or MDS replaces MDS Products pursuant to sections 11.3, 13.2 or 16.1, MDS will deliver or replace the MDS Products as soon as possible, on an expedited basis (via air freight, exclusive use truck, overtime customs clearance or similar means) at MDS’ expense if requested by Gambro.

          8.5 In addition to those rights set forth in Sections 5.4 and 8.4, and except as set forth in Sections 4.5, 4.7, 4.8 and 8.1, to the extent MDS is unable to deliver MDS Products within [**] days of the Delivery Window applicable to an accepted Gambro Delivery Order (the number of units of MDS Products not delivered within [**] days of the Delivery Window applicable to an accepted Gambro Delivery Order hereinafter referred to as the “Shortfall”), MDS shall promptly notify Gambro thereof and, in MDS’ sole discretion, deliver to Gambro within [**] days of the Delivery Window either (i) alternate MDS BTL in quantities equivalent to the Shortfall, or (ii) alternate Products at effective pricing no greater than as listed on Exhibit D for the MDS BTL subject to the Shortfall, provided such alternate Products are determined to be reasonably suitable alternatives by Gambro or its customers (such alternate Products under this Section 8.5 (ii) hereinafter referred to as “Substitute Product”) for purposes of addressing the Shortfall. If MDS does not have sufficient quantities of alternate MDS BTL to deliver to address the Shortfall within such [**] day window, or Gambro or its customers reasonably determines that no other alternate Product offered by MDS is a suitable alternative to the MDS BTL sold hereunder, then Gambro may, at its option, purchase replacement Products from other suppliers or manufactured by Gambro to the extent necessary to meet its and its customers’ immediate needs, up to the amount of the Shortfall, and [**] and in no event shall [**] hereunder. In the event MDS remains unable to deliver MDS Products or Substitute Products in full satisfaction of accepted Gambro Delivery Orders placed over [**] consecutive months, either Gambro or MDS may terminate this Agreement upon written notice to the other effective at the end of such [**] month period. In addition to the foregoing, Gambro also reserves the right to cancel outstanding accepted Gambro Delivery Orders if not delivered within [**] days of the Delivery Window and MDS is not able to provide, within that [**]day period, assurances reasonably acceptable to Gambro that MDS will be able to fulfill those outstanding orders.

          8.6 In addition to the rights and obligations set forth in Section 8.5, MDS shall[**], and provided that Gambro will [**]; and provided further that MDS shall have no obligation to[**] pursuant hereto over the Term of this Agreement. MDS may [**]

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