Common use of Failure to Supply Clause in Contracts

Failure to Supply. In the event MDS cannot supply or does not deliver any MDS PRODUCT(S) (whether as a result of force majeure or otherwise) within and for the time period pursuant to the agreement between MDS and DVA’s chosen MDS CONTRACT DISTRIBUTOR, MDS agrees that it shall give notice as promptly as is practicable under the circumstances to DVA, unless an order of a regulatory agency or other action arising out of patient safety concerns requires the giving of shorter notice. In the event MDS is unable to fulfill MDS CONTRACT DISTRIBUTOR’S contractually placed orders within the provisions of such agreement at any time during the Term of this Agreement, other than by action of the FDA, DVA’s chosen MDS CONTRACT DISTRIBUTOR shall be entitled, at a minimum, to have the same proportion of its purchase orders fulfilled at all times as other purchasers of the MDS PRODUCTS and, upon written request, MDS shall provide written assurances of same to DVA and its chosen MDS CONTRACT DISTRIBUTOR. In addition, in such circumstances, (a) any purchases of other codes of MDS bloodlines or access devices, as the case may be, or other manufacturers’ products by DVA shall count as MDS PRODUCT unit purchases for purposes of the BLOODLINE commitment, the AVF COMMITMENT and any MEDIC COMMITMENT and for purposes of the tier pricing and rebates for MEDIC products not subject to any MEDIC COMMITMENT set forth in Schedule B; and (b) MDS has the right to offer to DVA substitute MDS PRODUCTS at effective pricing no greater than as listed on Schedule B; and (c) if the failure to supply was not the result of force majeure [**] then MDS shall [**] and what DVA [**], but in no case shall MDS be liable for payment to DVA of such difference in excess of $[**] per pair for BLOOD TUBING PRODUCTS, $[**] per each equivalent for AVF NEEDLE SETS or $[**] per each equivalent for MEDIC. Notwithstanding the foregoing, if MDS’ failure to supply MDS PRODUCTS persists for longer than sixty (60) days and MDS is unable to provide reasonably acceptable alternative MDS PRODUCTS, DVA may terminate this Agreement effective at the end of such sixty (60) day period.

Failure to Supply. In the event MDS cannot that Ivivi shall be unable or unwilling or shall otherwise fail to supply or does not deliver at least [*], of the Product conforming to the Specifications and other terms and conditions of this Agreement as Allergan shall order [*] and in compliance with the delivery periods set forth in the purchase orders submitted by Allergan in accordance with SECTION 4.2(b) hereof (any MDS PRODUCT(Ssuch failure hereinafter referred to as a "FAILURE TO SUPPLY"), then Ivivi shall take prompt action to procure an alternate Product manufacturer and shall take all necessary and reasonable steps to enable such alternate Product manufacturer to produce the Product (and provide Allergan written confirmation thereof) (whether such action and steps to be collectively referred to herein as a result of force majeure or otherwise) within and for the time period pursuant to the agreement between MDS and DVA’s chosen MDS CONTRACT DISTRIBUTOR, MDS agrees that it shall give notice as promptly as is practicable under the circumstances to DVA, unless an order of a regulatory agency or other action arising out of patient safety concerns requires the giving of shorter notice"CORRECTIVE ACTION"). In the event MDS that the Failure to Supply is based on Ivivi's failure to meet (a) [*] and Ivivi (i) fails to take the Corrective Action or is unable to fulfill MDS CONTRACT DISTRIBUTOR’S contractually placed orders procure and enable an alternate Product manufacturer to produce the Product such that the alternate Product manufacturer shall have begun production of the Product no later than the date which is [*] after written notice from Allergan (and provide Allergan written confirmation thereof) and (ii) has not provided written notice to Allergan within [*] days of the provisions Failure to Supply of its intent to deliver all Units that had been ordered but not supplied, and actually delivers all such ordered but not supplied Units within [*] days of such agreement Failure to Supply, or (b) [*] and Ivivi fails to take the Corrective Action or is unable to procure and enable an alternate Product manufacturer to produce the Product within [*] of written notice from Allergan (and provide Allergan written confirmation thereof), then Allergan shall have the right to exercise the license rights granted in SECTION 3.1(b) of this Agreement (the date such right becomes exercisable, the "ALLERGAN MANUFACTURING LICENSE COMMENCEMENT DATE") and to use the information described in SECTION 4.4, and, at any Allergan's sole discretion, Allergan may continue to use its rights thereunder until such time during as (x) Ivivi demonstrates to Allergan's reasonable satisfaction that Ivivi is able to fully resume its supply obligations hereunder, (y) Ivivi pays all costs and expenses associated with resuming such manufacture, including, without limitation, paying all costs and expenses associated with the Term termination of and transition from Allergan's then existing supplier, and (z) Ivivi actually fully resumes its supply obligations hereunder (such time period from the Allergan Manufacturing License Commencement Date to the end date described in the immediately preceding clauses (x) through (z), a "MANUFACTURING LICENSE PERIOD"), in which case, the Manufacturing License Period shall be suspended and Allergan shall thereafter purchase Product exclusively from Ivivi in accordance with the terms of this Agreement. If Allergan engages a third party to produce or manufacture the Product during the Manufacturing License Period, other than by action of the FDA, DVA’s chosen MDS CONTRACT DISTRIBUTOR shall be entitled, at a minimum, to have the same proportion of its purchase orders fulfilled at all times as other purchasers of the MDS PRODUCTS and, upon written request, MDS shall provide written assurances of same to DVA and its chosen MDS CONTRACT DISTRIBUTOR. In additionthen, in negotiating a reasonable commercial agreement with such circumstancesthird-party supplier, Allergan shall make a reasonable good faith effort to provide for reasonable termination costs so long as obtaining such termination provisions does not cause the price Allergan pays for the Product to exceed the Transfer Price Allergan would have otherwise paid Ivivi hereunder. If the price Allergan pays for a Unit of Product or Allergan's cost to produce a Unit of Product (athe "PRODUCT UNIT REPLACEMENT COST") any purchases of other codes of MDS bloodlines or access devices, as the case may be, or other manufacturers’ products by DVA shall count as MDS PRODUCT unit purchases for purposes of the BLOODLINE commitment, the AVF COMMITMENT and any MEDIC COMMITMENT and for purposes of the tier pricing and rebates for MEDIC products not subject to any MEDIC COMMITMENT set forth in Schedule B; and (b) MDS has the right to offer to DVA substitute MDS PRODUCTS at effective pricing no is greater than as listed on Schedule B; and the then applicable Transfer Price, which Allergan would otherwise have paid Ivivi hereunder for such Unit of Product (c) the "PRODUCT PRICE DIFFERENCE"), then Allergan shall deduct such Product Price Difference from the royalties required by SECTION 5.4 during the Manufacturing License Period (the royalties, less such deduction if applicable, are the failure to supply was not the result of force majeure [**] then MDS shall [**] and what DVA [**], but in no case shall MDS be liable for payment to DVA of such difference in excess of $[**] per pair for BLOOD TUBING PRODUCTS, $[**] per each equivalent for AVF NEEDLE SETS or $[**] per each equivalent for MEDIC. Notwithstanding the foregoing, if MDS’ failure to supply MDS PRODUCTS persists for longer than sixty (60) days and MDS is unable to provide reasonably acceptable alternative MDS PRODUCTS, DVA may terminate this Agreement effective at the end of such sixty (60) day period"MANUFACTURING LICENSE COMPENSATION").

Failure to Supply. In the event MDS cannot of Rockwell’s failure or inability to supply or does not deliver any MDS PRODUCT(S) (whether as a result of force majeure or otherwiseProduct(s) within and for the time period pursuant required by DaVita or any DaVita Facility, as applicable, including as a result of a force majeure event (e.g., act of God, fire, casualty, flood, war, act of terrorism, strike, lockout, labor trouble, failure of public utilities, injunction, epidemic, riot, insurrection, or any other circumstances beyond the reasonable control of Rockwell) (a “Failure to Supply Event”), Rockwell covenants and agrees, subject to any conflicting terms and conditions of any other distribution agreement of Rockwell entered into prior to the agreement between MDS and DVA’s chosen MDS CONTRACT DISTRIBUTOREffective Date of this Agreement, MDS agrees that it shall (a) give notice as promptly as is practicable under the circumstances circumstances, but in no event more than [***], to DVADaVita of such Failure to Supply Event, unless an order of a regulatory agency or other action arising out of patient safety concerns requires the giving of shorter notice. In ; (b) allocate any available quantities of any such Product(s) affected by such Failure to Supply Event (exclusive of the event MDS is unable to fulfill MDS CONTRACT DISTRIBUTOR’S contractually placed orders within the provisions inventory of such agreement at Product(s) reserved by Rockwell for use by DaVita and the DaVita Facilities pursuant to Article VII, which inventory shall be solely for the use of DaVita and the DaVita Facilities) to DaVita and the DaVita Facilities, in accordance with the percentage of purchases of any time such Product(s) made by DaVita and the DaVita Facilities from Rockwell during the Term [***] period immediately preceding such Failure to Supply Event in proportion to the percentage of purchases made by all other purchasers of any such Product(s) from Rockwell during the [***] period immediately preceding such Failure to Supply Event; (c) not intentionally discriminate against DaVita and the DaVita Facilities in its allocation of the available quantities of any such Product(s) affected by such Failure to Supply Event by making its allocation decisions, in whole or in part, on the basis of the prices, discounts, or other financial terms offered to DaVita and the DaVita Facilities pursuant to the terms and conditions of this Agreement; (d) compensate DaVita and the DaVita Facilities for (i) the difference between (A) the net price that DaVita and the DaVita Facilities have to pay for any alternative product(s) that DaVita and the DaVita Facilities purchase and (B) the Purchase Price that DaVita and the DaVita Facilities would have paid under this Agreement if Rockwell had been able to supply any such Product(s) affected by such Failure to Supply Event and (ii) all additional freight, other than by action of the FDAhandling, DVA’s chosen MDS CONTRACT DISTRIBUTOR shall be entitled, at a minimum, to have the same proportion of its purchase orders fulfilled at all times as other purchasers of the MDS PRODUCTS and, upon written request, MDS shall provide written assurances of same to DVA and its chosen MDS CONTRACT DISTRIBUTOR. In addition, in such circumstances, (a) any purchases of other codes of MDS bloodlines or access devices, as the case may beshipping, or other manufacturers’ products service costs incurred by DVA shall count as MDS PRODUCT unit purchases for purposes of DaVita or the BLOODLINE commitment, the AVF COMMITMENT and any MEDIC COMMITMENT and for purposes of the tier pricing and rebates for MEDIC products not subject DaVita Facilities in acquiring an alternative product(s) in connection with such Failure to any MEDIC COMMITMENT set forth in Schedule BSupply Event; and (be) MDS has continue to perform its other obligations hereunder that are not affected by such Failure to Supply Event. Rockwell agrees to use commercially reasonable efforts to negotiate an amendment to any distribution agreement that may conflict with the right terms of ARTICLE VI of this Agreement. Rockwell further covenants and agrees that during the period that a Failure to offer Supply Event is occurring, none of the Committed DaVita Facilities shall be subject to DVA substitute MDS PRODUCTS at effective pricing no greater than as listed on Schedule B; and (c) if the failure to supply was not the result of force majeure [**] then MDS shall [**] and what DVA [**], but in no case shall MDS be liable for payment to DVA of such difference in excess of $[**] per pair for BLOOD TUBING PRODUCTS, $[**] per each equivalent for AVF NEEDLE SETS or $[**] per each equivalent for MEDIC. Notwithstanding the foregoing, if MDS’ failure to supply MDS PRODUCTS persists for longer than sixty (60) days and MDS is unable to provide reasonably acceptable alternative MDS PRODUCTS, DVA may terminate this Agreement effective at the end of such sixty (60) day periodProduct Commitment.

Failure to Supply. In the event MDS cannot Supplier fails to supply or does not deliver and release at least [*]% of the Batches under accepted Purchase Orders covering any MDS PRODUCT(S) (whether period of a [*] days, solely and directly as a result of force majeure or otherwiseSupplier’s: (i) within and for the time period pursuant negligence; (ii) failure to adhere to the agreement between MDS and DVA’s chosen MDS CONTRACT DISTRIBUTOR, MDS agrees that it shall give notice as promptly as is practicable under the circumstances to DVA, unless an order of a regulatory agency or other action arising out of patient safety concerns requires the giving of shorter notice. In the event MDS is unable to fulfill MDS CONTRACT DISTRIBUTOR’S contractually placed orders within the provisions of such agreement at any time during the Term terms of this Agreement; or (iii) failure to materially comply with cGMP or other Applicable Law, other than by then the Parties will meet and agree on and implement a delivery improvement action plan within [*]. If after implementation of such action plan there is subsequently a failure to supply and release at least [*]% of the FDABatches under accepted Purchase Orders covering any [*] period solely and directly as a result of Supplier’s (i) negligence; (ii) failure to adhere to the terms of this Agreement or (iii) failure to materially comply with cGMP or other Applicable Law, DVA’s chosen MDS CONTRACT DISTRIBUTOR shall be entitled, at a minimum, to have the same proportion of its purchase orders fulfilled at all times as other purchasers of the MDS PRODUCTS and, upon written request, MDS shall provide written assurances of same to DVA and its chosen MDS CONTRACT DISTRIBUTOR. In addition, in such circumstances, (a) any purchases of other codes of MDS bloodlines or access devicesthen Company, as the case may be, or other manufacturers’ products by DVA its sole and exclusive remedy shall count as MDS PRODUCT unit purchases for purposes of the BLOODLINE commitment, the AVF COMMITMENT and any MEDIC COMMITMENT and for purposes of the tier pricing and rebates for MEDIC products not subject to any MEDIC COMMITMENT set forth in Schedule B; and (b) MDS has have the right to offer terminate this Agreement immediately upon written notice, including the right to DVA substitute MDS PRODUCTS at effective pricing no greater than as listed cancel outstanding purchase orders without a cancellation fee, and in such case will be responsible only for paying for services properly performed and non-cancellable commitments of Supplier up to the date of termination. Company and Supplier acknowledge and agree that all Production timelines and target yields are approximate and subject to risks and uncertainties inherent, for example, in technology transfer and the biopharmaceutical industry generally and in the Production materials and technologies. The Company and Supplier agree to negotiate in good faith an appropriate yield target, tolerances and minimum obligation per Batch following the validation of Company’s process and the subsequent Production and release of [*] Batches of Company Product, along with Batch price adjustments (up or down) in the event of a shortfall due to the fault of Supplier or in the event of excess or below minimum yield. All process parameters and uniformity data for the PPQ Batches will be considered in this negotiation. Supplier will be responsible for refunding the full amount of any remaining depreciation on Schedule B; the Equipment and (c) if Facilities that Company has funded with the Company Contribution. Additionally, Supplier will be subject to [*]% penalty of the cumulative amount of remaining depreciated values of the Equipment and lost revenues during the failure to supply was not the result of force majeure [**] then MDS shall [**] and what DVA [**], but in no case shall MDS be liable for payment to DVA of such difference in excess of $[**] per pair for BLOOD TUBING PRODUCTS, $[**] per each equivalent for AVF NEEDLE SETS or $[**] per each equivalent for MEDICperiod. Notwithstanding the foregoing, if MDS’ Company shall not be entitled to terminate this Agreement or any outstanding purchase orders, and Supplier shall not be responsible for any refunds or any of the Batches are not fulfilled to the extent due to Company’s actions or inactions, including but not limited to Company’s failure to supply MDS PRODUCTS persists for longer than sixty (60) days and MDS is unable to provide reasonably acceptable alternative MDS PRODUCTS[*] or Company supplied Materials, DVA may terminate this Agreement effective at the end of such sixty (60) day periodor a Force Majeure event.

Failure to Supply. Notwithstanding the provisions of Section 12.01, in the event that any of the following occur: (a) Alba notifies Ortho (pursuant to Section 12.01 or otherwise) that Alba will not be able to fulfill Ortho’s Purchase Order; (b) Ortho has sent Alba a notice of termination in accordance with Section 8.02 following Alba’s failure to cure the breach; (c) Alba does not supply the OrthoSera Product within one hundred and eighty (180) days or any Products other than the OrthoSera Products within ninety (90) days of the scheduled delivery date as set forth in any Purchase order (whether due to the occurrence of a Force Majeure Event, any event listed in Section 8.03 above, or following the commencement of a case by or against Alba under Section 365(n) of Title 11 of the U.S. Code ("Title 11") or otherwise) (each of (a) through (c) are referred to as a “Failure to Supply”), then immediately following such Failure to Supply and through and until such time as Alba fully resumes its supply obligations pursuant to this Agreement, (i) Ortho may, in addition to any other rights and remedies hereunder, use, sell make and have made Product and any Raw Materials pursuant to the license granted in Section 12.03; (ii) Ortho may designate a third party manufacturer of the Products or manufacture such Product for itself (with no obligation or liability to Alba); (iii) Alba shall provide Ortho and such other manufacturer with assistance, as reasonably requested, in connection with such manufacturer’s or Ortho’s efforts to supply Product to Ortho, including: (I) Alba shall use commercially reasonable efforts to allow to (a) facilitate conversations between Ortho and the owner of the Facility (in which the Products are made at the time of the Failure to Supply) to grant Ortho access to the Facility and its software, plant, machinery and know how to assist with the manufacture of the Products and grant Ortho access to the process for the manufacture of the Products, and (b) facilitate conversations between Alba’s employees and staff and Ortho and, to the extent permissible by applicable law, grant Ortho the opportunity to participate in efforts to re-establish and maintain supply of the Products and liaise with such employees and staff; (II) Alba shall use its reasonable endeavors to ensure any contract counterparty, including suppliers of Raw Materials, to provide their services or any part of their services directly to Ortho; (III) Alba shall make such filings with such regulators as are necessary and appropriate; November 19, 2018 (IV) for sake of clarity, Ortho shall pay the Price (as adjusted) for any Product supplied by Alba, less all reasonable costs incurred by Ortho in connection with the activities set forth in this clauses; (iv) Alba shall make available to Ortho or its designee access to all technical and proprietary materials, information, techniques and Intellectual Property Rights of Alba for Ortho to procure required Raw Materials or produce or arrange an alternative supplier of Raw Materials or Product. Notwithstanding anything to the contrary contained in this Agreement, in the event that Ortho shall make or have made the Product, pursuant to this Section 12.02, Ortho shall be permitted to disclose to any third party any Confidential Information as is reasonably necessary in connection with such activities (subject to such third party agreeing in writing to be bound by the terms of Article 15 hereof). In the event MDS cannot supply that Ortho shall purchase Product from another manufacturer or does not deliver any MDS PRODUCT(S) manufacture Product for itself pursuant to this Section 12.02 (whether other than as a result of force majeure or otherwise) within and for the time period pursuant to the agreement between MDS and DVA’s chosen MDS CONTRACT DISTRIBUTORa Force Majeure Event), MDS agrees that it shall give notice as promptly as is practicable under the circumstances to DVA, unless an order of a regulatory agency or other action arising out of patient safety concerns requires the giving of shorter notice. In the event MDS is unable to fulfill MDS CONTRACT DISTRIBUTOR’S contractually placed orders within the provisions of such agreement at any time during the Term of this Agreement, other than by action of the FDA, DVA’s chosen MDS CONTRACT DISTRIBUTOR Alba shall be entitled, at a minimum, to have liable for all reasonable costs incurred by Ortho in connection with the same proportion of its purchase orders fulfilled at all times as other purchasers of the MDS PRODUCTS and, upon written request, MDS shall provide written assurances of same to DVA and its chosen MDS CONTRACT DISTRIBUTOR. In addition, in such circumstances, (a) any purchases of other codes of MDS bloodlines or access devices, as the case may be, or other manufacturers’ products by DVA shall count as MDS PRODUCT unit purchases for purposes of the BLOODLINE commitment, the AVF COMMITMENT and any MEDIC COMMITMENT and for purposes of the tier pricing and rebates for MEDIC products not subject to any MEDIC COMMITMENT activities set forth in Schedule B; clauses (i) through (v) above, including without limitation, costs for technical transfer, qualification, validation and (b) MDS has transfer of equipment and Raw Materials and costs of cover until the time when Alba can resume supply The foregoing shall be without prejudice to the Ortho’s other rights and remedies, including, without limitation, the right to offer to DVA substitute MDS PRODUCTS at effective pricing no greater than as listed on Schedule B; claim all direct damages and losses incurred (c) if the failure to supply was not the result of force majeure [**] then MDS shall [**] and what DVA [**], but in no case shall MDS be liable except for payment to DVA of such difference in excess of $[**] per pair for BLOOD TUBING PRODUCTS, $[**] per each equivalent for AVF NEEDLE SETS or $[**] per each equivalent for MEDICconsequential damages). Notwithstanding the foregoing, if MDS’ such inability, unwillingness or failure to supply MDS PRODUCTS persists for longer Products which conform with the applicable Specifications within the delivery periods set forth herein occurs more than sixty two (602) days and MDS is unable times in any calendar quarter (unless due to provide reasonably acceptable alternative MDS PRODUCTSa Force Majeure Event), DVA may terminate such inability, unwillingness or failure shall be deemed a material breach of this Agreement effective at the end of such sixty (60) day periodAgreement.

Failure to Supply. In the event MDS cannot supply or does not deliver any MDS NEEDLE PRODUCT(S) (whether as a result of force majeure or otherwise) within and for the time period pursuant to the agreement between MDS and DVA’s chosen MDS CONTRACT DISTRIBUTOR, MDS agrees that it shall give notice as promptly as is practicable under the circumstances to DVA, unless an order of a regulatory agency or other action arising out of patient safety concerns requires the giving of shorter notice. In the event MDS is unable to fulfill MDS CONTRACT DISTRIBUTOR’S contractually placed orders within the provisions of such agreement at any time during the Term of this Agreement, other than by action of the FDA, DVA’s chosen MDS CONTRACT DISTRIBUTOR shall be entitled, at a minimum, to have the same proportion of its purchase orders fulfilled at all times as other purchasers of the MDS NEEDLE PRODUCTS and, upon written request, MDS shall provide written assurances of same to DVA and its chosen MDS CONTRACT DISTRIBUTOR. In addition, in such circumstances, (a) any purchases of other codes of MDS bloodlines or access devices, as the case may be, needles or other manufacturers’ products by DVA shall count as MDS NEEDLE PRODUCT unit purchases for purposes of the BLOODLINE commitment, the AVF NEEDLE COMMITMENT and any MEDIC COMMITMENT and for purposes of the tier pricing and rebates for MEDIC products not subject to any MEDIC COMMITMENT set forth in Schedule B; and (b) MDS has the right to offer to DVA substitute MDS PRODUCTS needle products at effective pricing no greater than as listed on Schedule B; and (c) if the failure to supply was not the result of force majeure [**] ], then MDS shall [**] and what DVA [**], but in no case shall MDS be liable for payment to DVA of such difference in excess of $[**] per pair for BLOOD TUBING PRODUCTS, $[**] per each equivalent for AVF NEEDLE SETS or $[**] per each equivalent for MEDICButtonhole needle; and provided further that DVA shall not be entitled to any other damages or remedy whatsoever in connection with any failure to supply. Notwithstanding the foregoing, if MDS’ failure to supply MDS NEEDLE PRODUCTS persists for longer than sixty (60) days and MDS is unable to provide reasonably acceptable alternative MDS NEEDLE PRODUCTS, DVA may terminate this Agreement effective at the end of such sixty (60) day period.