Common use of Failure to Supply Clause in Contracts

Failure to Supply. In the event that any of the following occur: (a) Manufacturer notifies Buyer in accordance with Section 4.03 that Manufacturer will not be able to fulfill Buyer’s Purchase Order as requested by Buyer and which Purchase Order was requested in accordance with the terms herein (e.g., Buyer’s requested dates for delivery of Purchase Orders must comply with the requirements in Article 4 (except for those Purchase Orders that could not be completed as a result of Direct Supplier’s failure to supply as described in Section 4.03(a) ; (b) Manufacturer fails to fulfill the Purchase Order in accordance with the terms herein; (c) Buyer has sent Manufacturer a notice of termination in accordance with Section 8.01 or 8.02 (regardless of whether or not Manufacturer is attempting to correct such breach that triggered Buyer’s notice within Manufacturer’s thirty (30) day cure period); or (d) Manufacturer is otherwise unable or unwilling to supply Product that complies with the requirements herein in such quantities as Buyer shall request and in compliance with the delivery periods set forth in the applicable Purchase Order (whether due to the occurrence of a Force Majeure Event or otherwise) (each of (a) through (d) are referred to as a “Failure to Supply”), then (i) immediately following such Failure to Supply Buyer may, in addition to any other rights and remedies hereunder, purchase Product from another manufacturer or manufacture such Product for itself; (ii) Manufacturer shall provide Buyer and such other manufacturer with assistance, as reasonably requested, in connection with such manufacturer’s or Buyer’s efforts to supply such Product to Buyer; (iii) Buyer shall have no obligation to purchase such ordered Product from Manufacturer for sale or distribution in the Territory or otherwise until any contractual obligations that Buyer has assumed in connection with producing the same or obtaining such substitute source of supply shall have terminated or if Buyer opts to manufacture internally, until Buyer can reasonably resume purchasing Product from Manufacturer without any additional cost to Buyer; (iv) Buyer shall have no obligation to affirmatively terminate any such contractual arrangements or, if Buyer opted to manufacture Product internally, cease manufacturing internally prior to such time that Buyer could revert to Manufacturer without incurring any cost; and (v) Manufacturer shall make available to Buyer or its designee access to all technical and proprietary materials, information and techniques necessary or helpful for Buyer to procure required Raw Materials or Product or arrange an alternative supplier of Raw Materials or Product. Notwithstanding anything to the contrary contained in this Agreement, in the event that Buyer shall make or have made Product, pursuant to this Section 12.02, Buyer 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), save and except for the direct labour (variable costs), fixed overhead costs and profit margins of the Manufacturer.

Failure to Supply. In (a) Notwithstanding the provisions of Section 13.4, in the event that during the Exclusivity Period, COMPANY shall be unable or unwilling or has failed for any reason (including as a result of the following occur: bankruptcy or insolvency of COMPANY to the extent permitted by law) to deliver to DISTRIBUTOR with at least (a***) Manufacturer notifies Buyer percent (***%), in dollar amounts, of Calibrators, Continuous Monitoring Products, or Intermittent Monitoring Products ordered by DISTRIBUTOR, in the aggregate, pursuant to firm, binding purchase orders in any (***) consecutive Fiscal Quarters in accordance with Section 4.03 that Manufacturer will not be able to fulfill Buyer’s Purchase Order as requested by Buyer and which Purchase Order was requested in accordance with the terms herein 4.4 hereof (e.g., Buyer’s requested dates for delivery of Purchase Orders must comply with the requirements in Article 4 (except for those Purchase Orders that could not be completed as a result of Direct Supplier’s failure to supply as described in Section 4.03(a) ; (b) Manufacturer fails to fulfill the Purchase Order in accordance with the terms herein; (c) Buyer has sent Manufacturer a notice of termination in accordance with Section 8.01 or 8.02 (regardless of whether or not Manufacturer is attempting to correct such breach that triggered Buyer’s notice within Manufacturer’s thirty (30) day cure period); or (d) Manufacturer is otherwise unable or unwilling to supply Product that complies with the requirements herein in such quantities as Buyer shall request and in compliance with the delivery periods set forth in the applicable Purchase Order (whether due to the occurrence of a Force Majeure Event or otherwise) (each of (a) through (d) are referred to as a “"Failure to Supply”"), then then, upon ninety (i90) immediately following days written notice from DISTRIBUTOR, if COMPANY has failed to cure the breach during such ninety (90) day period, which cure may include the use of a third party manufacturer of Products that has satisfied the DISTRIBUTOR's Supplier Certification Process, DISTRIBUTOR may make and have made the Product or Products causing the Failure to Supply (the "Licensed Products") in order to supply its own requirements and the requirements of its Affiliates and Subdistributors for such Licensed Products until termination of the license as provided in Section 4.11(b) below (such time period, a "License Period"). COMPANY shall be deemed to have cured such Failure to Supply Buyer mayif, in addition during such cure period, it supplies (i) the shortfall between the amount actually delivered to any other rights DISTRIBUTOR and remedies hereundersuch (***)% level, purchase Product from another manufacturer or manufacture such Product for itself; and (ii) Manufacturer at least (***)% of the applicable Products (e.g., Calibrators, Continuous Monitoring Products or Intermittent Monitoring Products) ordered by DISTRIBUTOR pursuant to firm, binding purchase orders for delivery during the cure period and otherwise due for shipment to DISTRIBUTOR during such cure period. On or before May 1, 2000, COMPANY shall provide Buyer deliver to a third party escrow agent, reasonably acceptable to DISTRIBUTOR, and such other COMPANY shall update from time to time thereafter, a complete manufacturing documentation package, sufficient in detail and extent to allow a manufacturer with assistanceof DISTRIBUTOR's qualifications to manufacture Products. Such materials shall be released to DISTRIBUTOR in the event of a Failure to Supply, which Failure is not cured by COMPANY as reasonably requestedprovided in this Section 4.11(a). (b) If DISTRIBUTOR exercises its rights to manufacture under this Section 4.11, in connection with such manufacturer’s or Buyer’s efforts to supply such Product to Buyer; (iii) Buyer DISTRIBUTOR shall have no obligation to purchase such ordered Product the Licensed Products from Manufacturer COMPANY; provided however that if so requested by DISTRIBUTOR, COMPANY shall -------- *** Denotes confidential information that has been omitted from the exhibit and filed separately, accompanied by a confidential treatment request, with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934. continue to supply the Licensed Products at volumes consistent with COMPANY's then current capacity, and at the pricing set forth on Exhibit 5.3. (c) COMPANY hereby grants to DISTRIBUTOR a worldwide license, which license shall be non-transferable except for sale the limited right to grant sublicenses to its Affiliates or distribution third parties reasonably acceptable to COMPANY, under the COMPANY Technology in the Territory Field, to make and have made the Licensed Products in order to supply its own requirements and the requirements of its Affiliates and Subdistributors for such Licensed Products; provided that the license granted hereunder shall be effective only during License Periods and provided further that DISTRIBUTOR shall not exercise its rights under this License other than during such License Periods. Such license shall be exclusive during the Exclusivity Period, and if the Licensed Products include Sensors or otherwise until any contractual obligations that Buyer has assumed Cartridges, shall be non-exclusive beginning at the conclusion of the Exclusivity Period and continuing for the applicable period set forth in connection with producing the same Article 11. DISTRIBUTOR (or obtaining such substitute source of supply shall have terminated its Affiliate or if Buyer opts to manufacture internally, until Buyer can reasonably resume purchasing Product from Manufacturer without any additional cost to Buyer; (iv) Buyer shall have no obligation to affirmatively terminate any such contractual arrangements orthird party manufacturer, if Buyer opted any) shall pay to manufacture Product internallyCOMPANY a royalty equal to (***) percent (***%) of Net Sales of Licensed Products manufactured by or for DISTRIBUTOR under this Section 4.11. In the event of such Failure to Supply, cease manufacturing internally prior to such time that Buyer could revert to Manufacturer without incurring any cost; and (v) Manufacturer COMPANY shall make available to Buyer DISTRIBUTOR or its designee such Affiliate or third party manufacturer access to all and any other technical and proprietary materials, information and techniques necessary or helpful for Buyer DISTRIBUTOR to manufacture products, including to procure required Raw Materials raw materials or Product produce or arrange an alternative supplier of Raw Materials or Product, and to provide advice and consultation in connection therewith. Notwithstanding anything COMPANY shall reimburse DISTRIBUTOR for any out-of-pocket costs and expenses (including without limitation reasonable attorneys' fees) reasonably incurred by DISTRIBUTOR to enforce COMPANY's obligations under this Section 4.12(c). (d) As used herein, (i) the contrary contained in this Agreementterm "Company Technology" shall mean any patents, trade marks and know how owned and controlled by COMPANY which cover the manufacture, maintenance and upgrade of the applicable Products in the event that Buyer Field and (ii) the term "Net Sales" shall make mean the gross revenues received from the sale of applicable Products to independent third parties during the applicable period less (A) discounts and rebates, (B) credits or have made Productallowances granted upon claims or returns, pursuant to this Section 12.02, Buyer 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 C) freight charges paid for delivery and (D) taxes and other governmental charges levied on or measured by the terms invoiced amount, and (E) any Uplift customarily applied to transfers between international Affiliates of Article 15 hereof), save and except for the direct labour (variable costs), fixed overhead costs and profit margins of the ManufacturerDISTRIBUTOR.

Failure to Supply. The parties will agree about the quantity to be delivered in forecasts that will be determined by the parties each year. In the event that any Ovamed fails (i) to satisfactorily supply at least [*******]% of the following occur: amount of Product in any particular order within [*******] days of the required delivery date or at least [*******]% of the amount of Product in any particular order within [*******] days of the required delivery date, (aii) Manufacturer notifies Buyer to substantially perform its obligations in connection with United States or other relevant Regulatory Approval of the Products and such failure has continued for more than [*******] days, or such longer period as reasonably necessary to cure such failure or such period required by the relevant Regulatory Approval authority, or (iii) to have adequate operational manufacturing facilities such that it is unable to manufacture Product, or unable to manufacture product in accordance with Specifications, for a period of [*******] days or more ((i), (ii) and (iii) individually or collectively referred to herein as the “Manufacturing Failure”), and (x) Ovamed does not, at the time, have the right to terminate this Agreement under Section 4.03 8.2.1 and (y) Collingwood has not, at the time, developed a commercial second source (on commercially reasonable terms) for a product that Manufacturer will not can be able substituted for the Product and that can meet the supply shortage resulting from Ovamed’s failure to fulfill Buyer’s Purchase Order supply, then, upon notice of such failure from Collingwood, Collingwood may terminate this Agreement and receive a worldwide, royalty-free, perpetual, non-transferable (except as set forth in Section 13.3 below), non-exclusive, fully paid license, with the right to grant sublicenses for the sole purpose of manufacturing the Product on behalf of Collingwood (provided each such sublicensee signs a confidentiality agreement with Ovamed on terms consistent with the confidentiality obligations under this Agreement), under all intellectual property owned by Ovamed or for which Ovamed has the right to grant a license or sublicense pursuant to this Section and which is reasonably necessary or useful to manufacture and sell the Product in the Field of Use (the “Manufacturing IP”) (collectively, the “Manufacturing Failure License”), and such license shall be effective immediately upon notice of such election by Collingwood, and (b) Ovamed shall provide all assistance reasonably requested by Buyer and which Purchase Order was requested Collingwood to assist Collingwood or a third party acting on behalf of Collingwood in the manufacturing of the Product in accordance with the terms herein (e.g.Specifications, Buyer’s requested dates provided however, that Collingwood shall reimburse Ovamed for delivery any reasonable expenses it incurs in relation to its rendering of Purchase Orders must comply with the requirements in Article 4 (except for those Purchase Orders that could not be completed as a result of Direct Supplier’s failure to supply as described in Section 4.03(a) such assistance; (b) Manufacturer fails to fulfill the Purchase Order in accordance with the terms herein; (c) Buyer has sent Manufacturer a notice of termination in accordance with Section 8.01 or 8.02 (regardless of whether or not Manufacturer is attempting to correct such breach that triggered Buyer’s notice within Manufacturer’s thirty (30) day cure period); or (d) Manufacturer is otherwise unable or unwilling to supply Product that complies with the requirements herein in such quantities as Buyer shall request and in compliance with the delivery periods set forth in the applicable Purchase Order (whether due to the occurrence of a Force Majeure Event or otherwise) (each of (a) through (d) are referred to as a “Failure to Supply”), then (i) immediately following such Failure to Supply Buyer may, in addition to any other rights and remedies hereunder, purchase Product from another manufacturer or manufacture such Product for itself; (ii) Manufacturer shall provide Buyer and such other manufacturer with assistance, as reasonably requested, in connection with such manufacturer’s or Buyer’s efforts to supply such Product to Buyer; (iii) Buyer shall have no obligation to purchase such ordered Product from Manufacturer for sale or distribution in the Territory or otherwise until any contractual obligations that Buyer has assumed in connection with producing the same or obtaining such substitute source of supply shall have terminated or if Buyer opts to manufacture internally, until Buyer can reasonably resume purchasing Product from Manufacturer without any additional cost to Buyer; (iv) Buyer shall have no obligation to affirmatively terminate any such contractual arrangements or, if Buyer opted to manufacture Product internally, cease manufacturing internally prior to such time that Buyer could revert to Manufacturer without incurring any cost; and (v) Manufacturer shall make available to Buyer or its designee access to all technical and proprietary materials, information and techniques necessary or helpful for Buyer to procure required Raw Materials or Product or arrange an alternative supplier of Raw Materials or Product. Notwithstanding anything to the contrary contained herein, if Ovamed delivers to Collingwood a remediation plan reasonably acceptable according to which full remediation of any Manufacturing Failure will be achieved within [*******] months from the first date of such Manufacturing Failure, then this Agreement shall remain in this Agreementeffect, in provided however, that Collingwood shall have the event that Buyer shall make right to use and have used all Manufacturing IP to manufacture or have made Product, pursuant to this Section 12.02, Buyer manufactured Product during such period that Ovamed is engaged in such remediation. Such plan shall be permitted delivered to disclose Collingwood within 30 days after the failure occurred. Collingwood may terminate this Agreement immediately, without penalty or further obligation to any third party any Confidential Information as is reasonably necessary in connection with Ovamed, if Ovamed fails to achieve remediation within such activities (subject [*******] month period and Collingwood shall immediately be entitled to such third party agreeing in writing to be bound by the terms of Article 15 hereof), save and except for the direct labour (variable costs), fixed overhead costs and profit margins of the ManufacturerManufacturing Failure License.

Failure to Supply. In the event of Rockwell’s failure or inability to supply any Product(s) within and for the time period 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 Effective Date of this Agreement, that any of the following occur: it shall (a) Manufacturer notifies Buyer give notice as promptly as is practicable under the circumstances, but in accordance with Section 4.03 that Manufacturer will not no event more than [***], to DaVita 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; (b) allocate any available quantities of any such Product(s) affected by such Failure to Supply Event (exclusive of the inventory of such Product(s) reserved by Rockwell for use by DaVita and the DaVita Facilities pursuant to Article VII, which inventory shall be able solely for the use of DaVita and the DaVita Facilities) to fulfill Buyer’s Purchase Order as requested by Buyer DaVita and which Purchase Order was requested the DaVita Facilities, in accordance with the terms herein (e.g., Buyer’s requested dates for delivery percentage of Purchase Orders must comply with purchases of any such Product(s) made by DaVita and the requirements DaVita Facilities from Rockwell during the [***] period immediately preceding such Failure to Supply Event in Article 4 (except for those Purchase Orders that could not be completed as a result proportion to the percentage of Direct Supplier’s failure purchases made by all other purchasers of any such Product(s) from Rockwell during the [***] period immediately preceding such Failure to supply as described in Section 4.03(a) ; (b) Manufacturer fails to fulfill the Purchase Order in accordance with the terms hereinSupply Event; (c) Buyer has sent Manufacturer a notice not intentionally discriminate against DaVita and the DaVita Facilities in its allocation of termination in accordance with Section 8.01 or 8.02 (regardless the available quantities of whether or not Manufacturer is attempting to correct any such breach that triggered Buyer’s notice within Manufacturer’s thirty (30Product(s) day cure period); or (d) Manufacturer is otherwise unable or unwilling to supply Product that complies with the requirements herein in such quantities as Buyer shall request and in compliance with the delivery periods set forth in the applicable Purchase Order (whether due to the occurrence of a Force Majeure Event or otherwise) (each of (a) through (d) are referred to as a “Failure to Supply”), then (i) immediately following affected by such Failure to Supply Buyer mayEvent by making its allocation decisions, in addition 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 other rights alternative product(s) that DaVita and remedies hereunder, the DaVita Facilities purchase Product from another manufacturer or manufacture 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 for itself; Product(s) affected by such Failure to Supply Event and (ii) Manufacturer shall provide Buyer and such other manufacturer with assistanceall additional freight, as reasonably requestedhandling, shipping, or service costs incurred by DaVita or the DaVita Facilities in acquiring an alternative product(s) in connection with such manufacturer’s or Buyer’s efforts Failure to supply such Product to Buyer; (iii) Buyer shall have no obligation to purchase such ordered Product from Manufacturer for sale or distribution in the Territory or otherwise until any contractual obligations that Buyer has assumed in connection with producing the same or obtaining such substitute source of supply shall have terminated or if Buyer opts to manufacture internally, until Buyer can reasonably resume purchasing Product from Manufacturer without any additional cost to Buyer; (iv) Buyer shall have no obligation to affirmatively terminate any such contractual arrangements or, if Buyer opted to manufacture Product internally, cease manufacturing internally prior to such time that Buyer could revert to Manufacturer without incurring any costSupply Event; and (ve) Manufacturer shall make available continue to Buyer or perform its designee access other obligations hereunder that are not affected by such Failure to all technical and proprietary materials, information and techniques necessary or helpful for Buyer Supply Event. Rockwell agrees to procure required Raw Materials or Product or arrange use commercially reasonable efforts to negotiate an alternative supplier of Raw Materials or Product. Notwithstanding anything to the contrary contained in this Agreement, in the event that Buyer shall make or have made Product, pursuant to this Section 12.02, Buyer shall be permitted to disclose amendment to any third party any Confidential Information as is reasonably necessary in connection distribution agreement that may conflict with such activities (subject to such third party agreeing in writing to be bound by the terms of Article 15 hereof)ARTICLE VI of this Agreement. Rockwell further covenants and agrees that during the period that a Failure to Supply Event is occurring, save and except for the direct labour (variable costs), fixed overhead costs and profit margins none of the ManufacturerCommitted DaVita Facilities shall be subject to the Product Commitment.

Failure to Supply. In Notwithstanding the provisions of Section 12.01, in the event that any of the following occur: : (a) Manufacturer Xxxx notifies Buyer in accordance with Ortho (pursuant to Section 4.03 12.01 or otherwise) that Manufacturer Xxxx will not be able to fulfill BuyerOrtho’s Purchase Order as requested by Buyer and which Purchase Order was requested in accordance with the terms herein (e.g., Buyer’s requested dates for delivery of Purchase Orders must comply with the requirements in Article 4 (except for those Purchase Orders that could not be completed as a result of Direct Supplier’s failure to supply as described in Section 4.03(a) ; Order; (b) Manufacturer fails to fulfill the Purchase Order in accordance with the terms herein; (c) Buyer Xxxxx has sent Manufacturer Alba a notice of termination in accordance with Section 8.01 8.02 following Xxxx’s failure to cure the breach; (c) Alba does not supply the OrthoSera Product within one hundred and eighty (180) days or 8.02 any Products other than the OrthoSera Products within ninety (regardless 90) days of whether or not Manufacturer is attempting to correct such breach that triggered Buyer’s notice within Manufacturer’s thirty (30) day cure period); or (d) Manufacturer is otherwise unable or unwilling to supply Product that complies with the requirements herein in such quantities scheduled delivery date as Buyer shall request and in compliance with the delivery periods set forth in the applicable any Purchase Order order (whether due to the occurrence of a Force Majeure Event 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 (dc) are referred to as a “Failure to Supply”), then (i) immediately following such Failure to Supply Buyer 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, purchase use, sell make and have made Product from another 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; itself (iiwith no obligation or liability to Alba); (iii) Manufacturer Alba shall provide Buyer Ortho and such other manufacturer with assistance, as reasonably requested, in connection with such manufacturer’s or BuyerOrtho’s efforts to supply such Product to Buyer; Ortho, including: (iiiI) Buyer Xxxx shall have no obligation use commercially reasonable efforts to purchase 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, xxxxx Xxxxx the opportunity to participate in efforts to re-establish and maintain supply of the Products and liaise with such ordered 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; (IV) for sake of clarity, Ortho shall pay the Price (as adjusted) for any Product from Manufacturer for sale or distribution in the Territory or otherwise until any contractual obligations that Buyer has assumed supplied by Xxxx, less all reasonable costs incurred by Ortho in connection with producing the same or obtaining such substitute source of supply shall have terminated or if Buyer opts to manufacture internally, until Buyer can reasonably resume purchasing Product from Manufacturer without any additional cost to Buyer; activities set forth in this clauses; (iv) Buyer shall have no obligation to affirmatively terminate any such contractual arrangements or, if Buyer opted to manufacture Product internally, cease manufacturing internally prior to such time that Buyer could revert to Manufacturer without incurring any cost; and (v) Manufacturer Alba shall make available to Buyer Ortho or its designee access to all technical and proprietary materials, information information, techniques and techniques necessary or helpful Intellectual Property Rights of Alba for Buyer Ortho to procure required Raw Materials or Product produce or arrange an alternative supplier of Raw Materials or Product. Notwithstanding anything to the contrary contained in this Agreement, in the event that Buyer Ortho shall make or have made the Product, pursuant to this Section 12.02, Buyer 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 that Ortho shall purchase Product from another manufacturer or manufacture Product for itself pursuant to this Section 12.02 (other than as a result of a Force Majeure Event), save Alba shall be liable for all reasonable costs incurred by Ortho in connection with the activities set forth in clauses (i) through (v) above, including without limitation, costs for technical transfer, qualification, validation and 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 claim all direct damages and losses incurred (except for consequential damages). Notwithstanding the direct labour foregoing, if such inability, unwillingness or failure to supply Products which conform with the applicable Specifications within the delivery periods set forth herein occurs more than two (variable costs2) times in any calendar quarter (unless due to a Force Majeure Event), fixed overhead costs and profit margins such inability, unwillingness or failure shall be deemed a material breach of the Manufacturerthis Agreement.

Failure to Supply. The parties will agree about the quantity to be delivered in forecasts that will be determined by the parties each year. In the event that any Ovamed fails (i) to satisfactorily supply at least [*******]% of the following occur: amount of Product in any particular order within [*******] of the required delivery date or at least [*******]% of the amount of Product in any particular order within [*******] of the required delivery date, (aii) Manufacturer notifies Buyer to substantially perform its obligations in connection with United States or other relevant Regulatory Approval of the Products and such failure has continued for more than [*******], or such longer period as reasonably necessary to cure such failure or such period required by the relevant Regulatory Approval authority, or (iii) to have adequate operational manufacturing facilities such that it is unable to manufacture Product, or unable to manufacture product in accordance with Specifications, for a period of [*******] or more ((i), (ii) and (iii) individually or collectively referred to herein as the “Manufacturing Failure”), and (x) Ovamed does not, at the time, have the right to terminate this Agreement under Section 4.03 8.2.1 and (y) Collingwood has not, at the time, developed a commercial second source (on commercially reasonable terms) for a product that Manufacturer will not can be able substituted for the Product and that can meet the supply shortage resulting from Ovamed’s failure to fulfill Buyer’s Purchase Order supply, then, upon notice of such failure from Collingwood, Collingwood may terminate this Agreement and receive a worldwide, royalty-free, perpetual, non-transferable (except as set forth in Section 13.3 below), non-exclusive, fully paid license, with the right to grant sublicenses for the sole purpose of manufacturing the Product on behalf of Collingwood (provided each such sublicensee signs a confidentiality agreement with Ovamed on terms consistent with the confidentiality obligations under this Agreement), under all intellectual property owned by Ovamed or for which Ovamed has the right to grant a license or sublicense pursuant to this Section and which is reasonably necessary or useful to manufacture and sell the Product in the Field of Use (the “Manufacturing IP”) (collectively, the “Manufacturing Failure License”), and such license shall be effective immediately upon notice of such election by Collingwood, and (b) Ovamed shall provide all assistance reasonably requested by Buyer and which Purchase Order was requested Collingwood to assist Collingwood or a third party acting on behalf of Collingwood in the manufacturing of the Product in accordance with the terms herein (e.g.Specifications, Buyer’s requested dates provided however, that Collingwood shall reimburse Ovamed for delivery any reasonable expenses it incurs in relation to its rendering of Purchase Orders must comply with the requirements in Article 4 (except for those Purchase Orders that could not be completed as a result of Direct Supplier’s failure to supply as described in Section 4.03(a) such assistance; (b) Manufacturer fails to fulfill the Purchase Order in accordance with the terms herein; (c) Buyer has sent Manufacturer a notice of termination in accordance with Section 8.01 or 8.02 (regardless of whether or not Manufacturer is attempting to correct such breach that triggered Buyer’s notice within Manufacturer’s thirty (30) day cure period); or (d) Manufacturer is otherwise unable or unwilling to supply Product that complies with the requirements herein in such quantities as Buyer shall request and in compliance with the delivery periods set forth in the applicable Purchase Order (whether due to the occurrence of a Force Majeure Event or otherwise) (each of (a) through (d) are referred to as a “Failure to Supply”), then (i) immediately following such Failure to Supply Buyer may, in addition to any other rights and remedies hereunder, purchase Product from another manufacturer or manufacture such Product for itself; (ii) Manufacturer shall provide Buyer and such other manufacturer with assistance, as reasonably requested, in connection with such manufacturer’s or Buyer’s efforts to supply such Product to Buyer; (iii) Buyer shall have no obligation to purchase such ordered Product from Manufacturer for sale or distribution in the Territory or otherwise until any contractual obligations that Buyer has assumed in connection with producing the same or obtaining such substitute source of supply shall have terminated or if Buyer opts to manufacture internally, until Buyer can reasonably resume purchasing Product from Manufacturer without any additional cost to Buyer; (iv) Buyer shall have no obligation to affirmatively terminate any such contractual arrangements or, if Buyer opted to manufacture Product internally, cease manufacturing internally prior to such time that Buyer could revert to Manufacturer without incurring any cost; and (v) Manufacturer shall make available to Buyer or its designee access to all technical and proprietary materials, information and techniques necessary or helpful for Buyer to procure required Raw Materials or Product or arrange an alternative supplier of Raw Materials or Product. Notwithstanding anything to the contrary contained herein, if Ovamed delivers to Collingwood a remediation plan reasonably acceptable according to which full remediation of any Manufacturing Failure will be achieved within [*******] from the first date of such Manufacturing Failure, then this Agreement shall remain in this Agreementeffect, in provided however, that Collingwood shall have the event that Buyer shall make right to use and have used all Manufacturing IP to manufacture or have made Product, pursuant to this Section 12.02, Buyer manufactured Product during such period that Ovamed is engaged in such remediation. Such plan shall be permitted delivered to disclose Collingwood within 30 days after the failure occurred. Collingwood may terminate this Agreement immediately, without penalty or further obligation to any third party any Confidential Information as is reasonably necessary in connection with Ovamed, if Ovamed fails to achieve remediation within such activities (subject [*******] period and Collingwood shall immediately be entitled to such third party agreeing in writing to be bound by the terms of Article 15 hereof), save and except for the direct labour (variable costs), fixed overhead costs and profit margins of the ManufacturerManufacturing Failure License.

Failure to Supply. In Notwithstanding the provisions of Section 11.1 (Force Majeure Events), in the event that any of the following occur: (a) Manufacturer notifies Buyer in accordance with Section 4.03 that Manufacturer will not Supplier shall be able to fulfill Buyer’s Purchase Order as requested by Buyer and which Purchase Order was requested in accordance with the terms herein (e.g., Buyer’s requested dates for delivery of Purchase Orders must comply with the requirements in Article 4 (except for those Purchase Orders that could not be completed as a result of Direct Supplier’s failure to supply as described in Section 4.03(a) ; (b) Manufacturer fails to fulfill the Purchase Order in accordance with the terms herein; (c) Buyer has sent Manufacturer a notice of termination in accordance with Section 8.01 or 8.02 (regardless of whether or not Manufacturer is attempting to correct such breach that triggered Buyer’s notice within Manufacturer’s thirty (30) day cure period); or (d) Manufacturer is otherwise unable or unwilling or April 21, 2006 Novavax Esprit Supply Agreement shall fail to supply any Product that complies with the requirements herein in such quantities as Buyer shall request and in compliance with the delivery periods set forth in the applicable Purchase Order Section 4.3 (Change Orders) (whether due to the occurrence of a Force Majeure Event Event, following the commencement of a case by or otherwise) against Supplier under the Bankruptcy Code or otherwise (each of (a) through (d) are hereinafter referred to as a “Failure to Supply”), then Buyer shall be permitted (i) immediately after the expiration of a *** cure period following written notice from Buyer to supplier of such Failure to Supply Buyer may, in addition and such Failure to any other rights and remedies hereunder, purchase Supply has not been cured by Supplier) to (i) to obtain such Product from another manufacturer supplier including Cardinal, or (ii) to use, sell, and make Product itself in the Cardinal Red Lion facility or at another location. In this regard, Supplier shall (at no cost to Supplier) take all actions and provide all such cooperation and support reasonably necessary and reasonably within its control to give Buyer the right to enter, upon reasonable notice and during regular business hours, and shall be given access to, the Facility (or any other location where the Equipment is used or stored) so that Buyer may use or retrieve all records maintained in connection with the manufacturing equipment. Supplier’s obligations under this Section shall survive the termination of this Agreement for a period of ***. Upon the occurrence of any such Failure to Supply and through and until such time as Supplier fully resumes its supply obligations hereunder: (a) Supplier shall (at no cost to Supplier) take all reasonable actions within its control, execute and deliver all documents, and provide all such assistance as Buyer reasonably requests to enable Buyer to obtain Product from another supplier or to manufacture such April 21, 2006 Novavax Esprit Supply Agreement Product for itself; (iib) Manufacturer Supplier shall provide Buyer and such other manufacturer with assistance, as reasonably requested, in connection with such manufacturer’s or Buyer’s efforts to supply such Product to Buyer; (iii) Buyer shall have at no obligation to purchase such ordered Product from Manufacturer for sale or distribution in the Territory or otherwise until any contractual obligations that Buyer has assumed in connection with producing the same or obtaining such substitute source of supply shall have terminated or if Buyer opts to manufacture internally, until Buyer can reasonably resume purchasing Product from Manufacturer without any additional cost to Buyer; (ivSupplier) Buyer shall have no obligation to affirmatively terminate any such contractual arrangements or, if Buyer opted to manufacture Product internally, cease manufacturing internally prior to such time that Buyer could revert to Manufacturer without incurring any cost; and (v) Manufacturer shall make available to Buyer or its designee access to any and all Intellectual Property Rights (to the extent not already granted pursuant to the License Agreement) and any other technical and proprietary materials, information and techniques necessary or helpful for Buyer to procure required Raw Materials or Product produce or arrange an alternative supplier of Raw Materials Product; (c) Supplier shall (at no cost to Supplier) provide advice and consultation in connection therewith; (d) Buyer shall purchase Product from Supplier once Supplier has cured the failure to supply; and (e) Buyer shall terminate any contractual arrangements contemplated by clause (a) of this sentence once Supplier has cured the failure to supply. As soon as reasonably practicable after an uncured Failure to Supply, Supplier shall furnish Buyer with Licensed Know-How (as defined in the License Agreement) which is necessary to enable Buyer to manufacture or have manufactured Product as contemplated by this Agreement. In the event either party hereto believes it to be in the best interest of both parties, as the licensor and licensee of the Licensed Product in the Territory, to designate and qualify an alternate contract manufacturer of the Licensed Product. Notwithstanding anything , each party shall consider in good faith the views of the other party as to the contrary contained in this Agreementadvisability of engaging an alternate contract manufacturer. If agreed by the parties that an alternate contract manufacturer should be designated and qualified, in the event that Buyer parties shall make or have made Product, pursuant cooperate to this Section 12.02, Buyer shall be permitted ensure the transition of the Licensed Product manufacturing to disclose to any a third party in a manner that minimizes any Confidential Information as is reasonably necessary in connection with such activities (subject to such third party agreeing in writing to be bound by interruption of supply of Licensed Product within the terms of Article 15 hereof)Territory. April 21, save and except for the direct labour (variable costs), fixed overhead costs and profit margins of the Manufacturer.2006 Novavax Esprit Supply Agreement

Failure to Supply. In the event that any of the following occur: (a) Manufacturer notifies Buyer in accordance with Section 4.03 that Manufacturer will not Ivivi shall be able to fulfill Buyer’s Purchase Order as requested by Buyer and which Purchase Order was requested in accordance with the terms herein (e.g., Buyer’s requested dates for delivery of Purchase Orders must comply with the requirements in Article 4 (except for those Purchase Orders that could not be completed as a result of Direct Supplier’s failure to supply as described in Section 4.03(a) ; (b) Manufacturer fails to fulfill the Purchase Order in accordance with the terms herein; (c) Buyer has sent Manufacturer a notice of termination in accordance with Section 8.01 or 8.02 (regardless of whether or not Manufacturer is attempting to correct such breach that triggered Buyer’s notice within Manufacturer’s thirty (30) day cure period); or (d) Manufacturer is otherwise unable or unwilling or shall otherwise fail to supply at least [*], of the Product that complies with conforming to the requirements herein in such quantities Specifications and other terms and conditions of this Agreement as Buyer Allergan shall request order [*] and in compliance with the delivery periods set forth in the applicable Purchase Order purchase orders submitted by Allergan in accordance with SECTION 4.2(b) hereof (whether due to the occurrence of a Force Majeure Event or otherwise) (each of (a) through (d) are any such 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) (such action and steps to be collectively referred to herein as the "CORRECTIVE ACTION"). In the event 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 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 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 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 (ithe date such right becomes exercisable, the "ALLERGAN MANUFACTURING LICENSE COMMENCEMENT DATE") and to use the information described in SECTION 4.4, and, at Allergan's sole discretion, Allergan may continue to use its rights thereunder until such time 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 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 following such Failure to Supply Buyer maypreceding clauses (x) through (z), a "MANUFACTURING LICENSE PERIOD"), in addition to any other rights which case, the Manufacturing License Period shall be suspended and remedies hereunder, Allergan shall thereafter purchase Product exclusively from another manufacturer or manufacture such Product for itself; (ii) Manufacturer shall provide Buyer and such other manufacturer Ivivi in accordance with assistance, as reasonably requested, in connection with such manufacturer’s or Buyer’s efforts to supply such Product to Buyer; (iii) Buyer shall have no obligation to purchase such ordered Product from Manufacturer for sale or distribution in the Territory or otherwise until any contractual obligations that Buyer has assumed in connection with producing the same or obtaining such substitute source of supply shall have terminated or if Buyer opts to manufacture internally, until Buyer can reasonably resume purchasing Product from Manufacturer without any additional cost to Buyer; (iv) Buyer shall have no obligation to affirmatively terminate any such contractual arrangements or, if Buyer opted to manufacture Product internally, cease manufacturing internally prior to such time that Buyer could revert to Manufacturer without incurring any cost; and (v) Manufacturer shall make available to Buyer or its designee access to all technical and proprietary materials, information and techniques necessary or helpful for Buyer to procure required Raw Materials or Product or arrange an alternative supplier of Raw Materials or Product. Notwithstanding anything to the contrary contained in this Agreement, in the event that Buyer shall make or have made Product, pursuant to this Section 12.02, Buyer 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 hereofthis Agreement. If Allergan engages a third party to produce or manufacture the Product during the Manufacturing License Period, then, in negotiating a reasonable commercial agreement with such third-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 (the "PRODUCT UNIT REPLACEMENT COST") is greater than the then applicable Transfer Price, which Allergan would otherwise have paid Ivivi hereunder for such Unit of Product (the "PRODUCT PRICE DIFFERENCE"), save and except for then Allergan shall deduct such Product Price Difference from the direct labour royalties required by SECTION 5.4 during the Manufacturing License Period (variable coststhe royalties, less such deduction if applicable, are the "MANUFACTURING LICENSE COMPENSATION"), fixed overhead costs and profit margins of the Manufacturer.

Failure to Supply. Subject to Section 15.1, if SHEARWATER cannot supply at least [**] percent ([**]%) of the amount of the REAGENT consistent with and at the times specified by Sections 4.3 and 4.4 and does not cure the deficiency within [**] days after EYETECH so notifies SHEARWATER in writing that a portion of the REAGENT due for delivery has not been delivered, after using all reasonable efforts, then SHEARWATER will be considered as being unable to manufacture and sell to EYETECH the REAGENT under this AGREEMENT ("FAILURE"). In the event that case of a FAILURE for any reason, SHEARWATER shall, subject to this Section 4.7, immediately work with EYETECH and grant to one THIRD PARTY contract manufacturer (the "CONTRACT MANUFACTURER" such CONTRACT MANUFACTURER being subject to approval by EYETECH, such approval to not be unreasonably withheld) a personal, non-assignable, non-exclusive right and license under the LICENSED TECHNOLOGY to make the amount of REAGENT, for the following occur: (a) Manufacturer notifies Buyer sole purpose of EYETECH producing the PRODUCT, in accordance with EYETECH'S order for the relevant calendar quarter as well as during the [**] in accordance with Section 4.03 that Manufacturer 4.8. Such FAILURE by SHEARWATER to supply EYETECH with the REAGENT will not be able taken as a refusal by SHEARWATER to fulfill Buyer’s Purchase Order as requested by Buyer and which Purchase Order was requested in accordance supply EYETECH with the terms herein (e.g.REAGENT for subsequent calendar quarters unless SHEARWATER so indicates. With respect to such subsequent calendar quarters, Buyer’s requested dates if SHEARWATER has demonstrated that it has the ability to supply all of EYETECH'S REAGENT requirements hereunder, EYETECH will resume purchases of the REAGENT from SHEARWATER in the manner provided for delivery by this AGREEMENT. [**]. Notwithstanding the foregoing, all of Purchase Orders must comply EYETECH'S milestone and royalty obligations shall remain in effect during the period of any FAILURE. If SHEARWATER, for any reason, shall [**] FAIL under this Section 4.7 to supply EYETECH with the requirements in Article 4 (except for those Purchase Orders that could not REAGENT, EYETECH shall thereafter be completed as a result of Direct Supplier’s failure allowed to supply as described in Section 4.03(a) ; (b) Manufacturer fails to fulfill the Purchase Order in accordance with the terms herein; (c) Buyer has sent Manufacturer a notice of termination in accordance with Section 8.01 or 8.02 (regardless of whether or not Manufacturer is attempting to correct such breach that triggered Buyer’s notice within Manufacturer’s thirty (30) day cure period); or (d) Manufacturer is otherwise unable or unwilling to supply Product that complies with the requirements herein in such quantities as Buyer shall request and in compliance with the delivery periods set forth in the applicable Purchase Order (whether due to the occurrence of a Force Majeure Event or otherwise) (each of (a) through (d) are referred to as a “Failure to Supply”), then (i) immediately following such Failure to Supply Buyer may, in addition to any other rights and remedies hereunder, purchase Product from another manufacturer or manufacture such Product for itself; (ii) Manufacturer shall provide Buyer and such other manufacturer with assistance, as reasonably requested, in connection with such manufacturer’s or Buyer’s efforts to supply such Product to Buyer; (iii) Buyer shall have no obligation to purchase such ordered Product from Manufacturer for sale or distribution in the Territory or otherwise until any contractual obligations that Buyer has assumed in connection with producing the same or obtaining such substitute source of supply shall have terminated or if Buyer opts to manufacture internally, until Buyer can reasonably resume purchasing Product from Manufacturer without any additional cost to Buyer; (iv) Buyer shall have no obligation to affirmatively terminate any such contractual arrangements or, if Buyer opted to manufacture Product internally, cease manufacturing internally prior to such time that Buyer could revert to Manufacturer without incurring any cost; and (v) Manufacturer shall make available to Buyer or its designee access to all technical and proprietary materials, information and techniques necessary or helpful for Buyer to procure required Raw Materials or Product or arrange an alternative supplier of Raw Materials or Product. Notwithstanding anything to the contrary contained in this Agreement, in the event that Buyer shall make or have made Product, pursuant to this Section 12.02, Buyer 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), save and except for the direct labour (variable costs), fixed overhead costs and profit margins of the Manufacturer[**].

Failure to Supply. In the event that (a) A Failure to Supply shall have occurred under this Agreement under any of the following occur: circumstances (aa“Failure to Supply”): (i) Manufacturer notifies Buyer Patheon fails to deliver a shipment of Product by the Delivery Date, and fails to replace such Product shipment within [**]) days after the scheduled Delivery Date; or (ii) Patheon fails to ship the complete number of ordered Batches by the Delivery Date, and Patheon fails to ship the remaining Batches within [**] days after the scheduled Delivery Date, and such failure occurs (A) with respect to Product shipments over [**] consecutive calendar quarters during any Year, or (B) with respect to [**] or more Product shipments in accordance with any Year; or (iii) Product delivered to Penwest or to a Penwest customer is determined to be defective for a reason set forth in the first Sentence of Section 4.03 6.3(a), and there are [**] or more such deliveries of defective Product in any one Year. (b) If a Failure to Supply occurs, then Penwest or its Affiliates, itself or on behalf of its licensees or customers, may at its election, (i) require Patheon to qualify, as soon as reasonably practicable and at Patheon’s cost, a second Patheon facility to manufacture and supply Product to Penwest hereunder, it being understood that Manufacturer Penwest shall have the right to approve such second Patheon facility, such approval not to be unreasonably withheld or delayed; and/or (ii) retain a Third Party to manufacture and supply the requirements of Penwest and its Affiliates’, licensees’ and customers’ requirements for Product. (c) Except as set forth in this Agreement, Patheon will not be able liable to fulfill Buyer’s Purchase Order Penwest nor have any responsibility to Penwest for any deficiencies in, or other liabilities associated with, any Product manufactured by it (collectively, “Product Claims”). For greater certainty, Patheon will have no obligation for any Product Claims to the extent the Product Claim (i) is caused by deficiencies in the Specifications as requested provided to Patheon by Buyer and which Purchase Order Penwest, the safety, efficacy, or marketability of the Products or any distribution thereof; provided that the Product was requested manufactured in accordance with the terms herein (e.g.Manufacturing Process, Buyer’s requested dates for delivery the Specifications, cGMPs and applicable Laws, and conformed to the Specifications at the time of Purchase Orders must comply with the requirements in Article 4 (except for those Purchase Orders that could not be completed as a result of Direct Supplier’s failure to supply as described in Section 4.03(a) shipment; (bii) Manufacturer fails results from a defect in a Component that is not reasonably discoverable by Patheon using the test methods set forth in the Specifications, (iii) results from Components supplied by Penwest that is not reasonably discoverable by Patheon using the test methods set forth in the Specifications, (iv) is caused by actions of Third Parties occurring after the Product is shipped by Patheon under Section 5.3, (v) is due to fulfill packaging design or labelling defects or omissions for which Patheon has no responsibility; provided that the Purchase Order Product was manufactured in accordance with the terms herein; Manufacturing Process, the Specifications, cGMPs and applicable Laws, and conformed to the Specifications at the time of shipment, (cvi) Buyer has sent Manufacturer a notice of termination is due to any unascertainable reason despite Patheon having performed the Manufacturing Services in accordance with Section 8.01 or 8.02 (regardless the Specifications, cGMP’s, the Manufacturing Process and applicable Laws and despite the Product having met the Specifications at the time of whether or not Manufacturer is attempting to correct such breach that triggered Buyer’s notice within Manufacturer’s thirty (30) day cure period); shipment, or (dvii) Manufacturer is otherwise unable or unwilling to supply Product that complies with the requirements herein in such quantities as Buyer shall request and in compliance with the delivery periods set forth in the applicable Purchase Order (whether due to the occurrence a breach by Penwest of a Force Majeure Event or otherwise) (each of (a) through (d) are referred to as a “Failure to Supply”), then (i) immediately following such Failure to Supply Buyer may, in addition to any other rights and remedies hereunder, purchase Product from another manufacturer or manufacture such Product for itself; (ii) Manufacturer shall provide Buyer and such other manufacturer with assistance, as reasonably requested, in connection with such manufacturer’s or Buyer’s efforts to supply such Product to Buyer; (iii) Buyer shall have no obligation to purchase such ordered Product from Manufacturer for sale or distribution in the Territory or otherwise until any contractual its obligations that Buyer has assumed in connection with producing the same or obtaining such substitute source of supply shall have terminated or if Buyer opts to manufacture internally, until Buyer can reasonably resume purchasing Product from Manufacturer without any additional cost to Buyer; (iv) Buyer shall have no obligation to affirmatively terminate any such contractual arrangements or, if Buyer opted to manufacture Product internally, cease manufacturing internally prior to such time that Buyer could revert to Manufacturer without incurring any cost; and (v) Manufacturer shall make available to Buyer or its designee access to all technical and proprietary materials, information and techniques necessary or helpful for Buyer to procure required Raw Materials or Product or arrange an alternative supplier of Raw Materials or Product. Notwithstanding anything to the contrary contained in under this Agreement, in the event that Buyer shall make or have made Product, pursuant to this Section 12.02, Buyer 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), save and except for the direct labour (variable costs), fixed overhead costs and profit margins of the Manufacturer.

Failure to Supply. In If ICU fails to deliver, or anticipates that it will be unable to deliver, Products ordered pursuant to the event that terms of this Agreement for 60 or more consecutive days past any Delivery Date, ICU will promptly notify Hospira. Hospira shall have the right to (i) agree to a revised delivery date, (ii) cancel some or all existing Purchase Orders for such Products without penalty, (iii) transfer the manufacture of such Products to itself or a Third Party, or (iv) to the following occur: (a) Manufacturer notifies Buyer extent such failure to supply is a material breach, terminate this Agreement in accordance with Section 4.03 that Manufacturer will 13.3. ICU shall not be able deemed to fulfill Buyer’s Purchase Order as requested have failed to deliver under the preceding sentence if it is unable to manufacture Products ordered by Buyer and which Purchase Order was requested in accordance with the terms herein (e.g., Buyer’s requested dates for delivery of Purchase Orders must comply with the requirements in Article 4 (except for those Purchase Orders that could not be completed Hospira as a direct result of Direct Supplier’s Hospira's failure to supply ICU with Specified Components under Section 5.2 hereof or as described in Section 4.03(a) ; a direct result of Hospira's breach of its obligations under Sections 3.1(a), (b) Manufacturer fails to fulfill the Purchase Order in accordance with the terms herein; or (c). If Hospira elects option (iii), ICU shall, if so requested by Hospira, (A) Buyer has sent Manufacturer a notice transfer and/or license to Hospira, as applicable, all know-how, technology, trade secrets and patent rights necessary to manufacture such Products (other than with respect to any component of termination in accordance with Section 8.01 or 8.02 (regardless of whether or not Manufacturer is attempting to correct such breach that triggered Buyer’s notice within Manufacturer’s thirty (30) day cure period); or (d) Manufacturer is otherwise unable or unwilling to supply Product that complies with the requirements herein in can be timely supplied by ICU), thereby enabling Hospira or its designee to manufacture such quantities as Buyer shall request and in compliance with the delivery periods set forth Products, (B) reasonably assist Hospira or its designee in the applicable Purchase Order (whether due to transfer and the occurrence start-up of a Force Majeure Event or otherwise) (each of (a) through (d) are referred to as a “Failure to Supply”)manufacturing operations for such Products and make all necessary plans, then (i) immediately following such Failure to Supply Buyer mayformulations and manufacturing processes, in addition to any procedures, test methods, specialized test equipment, and other rights and remedies hereunder, purchase Product from another manufacturer or manufacture such Product for itself; (ii) Manufacturer shall provide Buyer and such other manufacturer with assistance, as reasonably requested, in connection with such manufacturer’s or Buyer’s efforts to supply such Product to Buyer; (iii) Buyer shall have no obligation to purchase such ordered Product from Manufacturer for sale or distribution in the Territory or otherwise until any contractual obligations that Buyer has assumed in connection with producing the same or obtaining such substitute source of supply shall have terminated or if Buyer opts to manufacture internally, until Buyer can reasonably resume purchasing Product from Manufacturer without any additional cost to Buyer; (iv) Buyer shall have no obligation to affirmatively terminate any such contractual arrangements or, if Buyer opted to manufacture Product internally, cease manufacturing internally prior to such time that Buyer could revert to Manufacturer without incurring any cost; and (v) Manufacturer shall make items available to Buyer Hospira or its Confidential designee, (C) grant Hospira or its designee access to ICU's regulatory files relating to such Products, (D) transfer all Regulatory Approvals to Hospira necessary to manufacture, market and sell such Products, and (E) supply such other technical and proprietary materials, information and techniques necessary or helpful for Buyer to procure required Raw Materials or Product or arrange an alternative supplier of Raw Materials or Product. Notwithstanding anything to the contrary contained in this Agreement, in the event that Buyer shall make or have made Product, pursuant to this Section 12.02, Buyer shall be permitted to disclose to any third party any Confidential Information regulatory assistance as is reasonably necessary in connection with requested by Hospira or its designee. ICU hereby grants to Hospira, without the necessity of any further documentation, a non-exclusive, royalty free, irrevocable, worldwide right and license to ICU's know-how, technology, trade secrets and patent rights to make, have made, use and sell such activities Products. To the extent any know-how, technology, trade secrets or patent rights are owned, controlled or licensed by a Third Party (subject to such third party agreeing in writing to be bound by the terms of Article 15 hereof"Third Party Rights"), save and except are required to implement Hospira's right to manufacture or have manufactured such Products, ICU shall use its best efforts to obtain a license to all such Third Party Rights to allow Hospira or its designee to use such Third Party Rights for the direct labour (variable costs), fixed overhead costs and profit margins production of the ManufacturerProducts.

Failure to Supply. In If at any time during the event that any of the following occur: Term, (a) Manufacturer notifies Buyer in accordance with Section 4.03 that Manufacturer will not be able Company is unable to fulfill Buyer’s Purchase deliver Product pursuant to a Firm Order as requested by Buyer and which Purchase Order was requested in accordance with for a period longer than [***] after the terms herein (e.g., Buyer’s requested dates for applicable delivery of Purchase Orders must comply with the requirements in Article 4 (except for those Purchase Orders that could not be completed as a result of Direct Supplier’s failure to supply as described in Section 4.03(a) ; (b) Manufacturer fails to fulfill the Purchase Order in accordance with the terms herein; (c) Buyer has sent Manufacturer a notice of termination in accordance with Section 8.01 or 8.02 (regardless of whether or not Manufacturer is attempting to correct such breach that triggered Buyer’s notice within Manufacturer’s thirty (30) day cure period); or (d) Manufacturer is otherwise unable or unwilling to supply Product that complies with the requirements herein in such quantities as Buyer shall request and in compliance with the delivery periods date set forth in the applicable Purchase respective Firm Order for causes within Company’s control, or (whether due b) if the Company is unable to supply, or arrange to make available for shipment the occurrence Launch Quantity within [***] of a Force Majeure Event or otherwise) the Regulatory Approval for causes within Company’s control; then, in either case (each of (a) through (d) are referred to as such occurrence a “Failure to Supply”), then USWM may, upon [***] prior written notice to Company that a Failure to Supply has occurred, request in such notice that Company exercise, and Company shall, at Company’s sole cost and expense, [***] to (i) immediately evaluate, contract, and qualify a mutually agreeable alternate manufacturing facility to manufacture and supply all of USWM’s requirements of Product(s) in the Territory, (ii) transfer sufficient know-how to the alternate manufacturing facility in order to enable the facility to manufacture the Product(s) in accordance with the terms of this Agreement, and (iii) ensure that the alternate manufacturing facility is contractually obligated to use commercially reasonable efforts to be approved by the applicable Regulatory Authority to manufacture commercial quantities of the Product(s) and is brought up to production readiness as soon as reasonably possible following USWM’s written notice specified above. In the event an alternate manufacturing facility is utilized to supply Products under this Agreement, such facility shall be deemed a “Manufacturing Facility” for purposes of this Agreement. Subject to Company [***], the Parties may mutually agree to terminate this Agreement (either with respect to the ZIMHI Product or the SYMJEPI Product individually, or both Products collectively). Notwithstanding anything in this Section 11.2.2(a), in the event that a Failure to Supply Buyer arises by the willful act or omission of Company (and not for other reasons including without limitation acts or omissions of third parties beyond the reasonable control of Company or acts or omissions relating to [***] taken in good faith by Company), USWM may, in its sole discretion, elect to terminate this Agreement (either with respect to the ZIMHI Product or the SYMJEPI Product individually, or both Products collectively, as the case may be) at the end of such [***] notice period, and Company shall pay to USWM within [***] of the [***] an amount equal to [***]. In the event that either (i) Company fails to [***], or (ii) supply of the affected Product(s) fails to resume within [***] from [***], USWM may, in its sole discretion, elect to terminate this Agreement (either with respect to the ZIMHI Product or the SYMJEPI Product individually, or both Products collectively) unless supply of the affected Product(s) resumes during such [***] notice period and, in the event that USWM elects to terminate this Agreement (either with respect to the ZIMHI Product or the SYMJEPI Product individually, or both Products collectively, as the case may be) Company shall pay to USWM within [***] of the effective date of termination an amount equal to [***] of (a) [***], or (b) [***]. For purposes of clarity, the remedies available to USWM pursuant to this Section 11.2.2(a) are in addition to any other rights and remedies hereunder, purchase Product from another manufacturer or manufacture such Product for itself; (ii) Manufacturer shall provide Buyer and such other manufacturer with assistance, as reasonably requested, in connection with such manufacturer’s or Buyer’s efforts to supply such Product to Buyer; (iii) Buyer shall have no obligation to purchase such ordered Product from Manufacturer for sale or distribution in the Territory or otherwise until any contractual obligations that Buyer has assumed in connection with producing the same or obtaining such substitute source of supply shall have terminated or if Buyer opts to manufacture internally, until Buyer can reasonably resume purchasing Product from Manufacturer without any additional cost to Buyer; (iv) Buyer shall have no obligation to affirmatively terminate any such contractual arrangements or, if Buyer opted to manufacture Product internally, cease manufacturing internally prior to such time that Buyer could revert to Manufacturer without incurring any cost; and (v) Manufacturer shall make available to Buyer or its designee access to all technical and proprietary materials, information and techniques necessary or helpful for Buyer to procure required Raw Materials or Product or arrange an alternative supplier of Raw Materials or Product. Notwithstanding anything to the contrary contained in USWM under this Agreement, in the event that Buyer shall make or have made Productincluding without limitation, USWM’s indemnification rights pursuant to Section 8.1. Notwithstanding the foregoing, USWM shall not be entitled to exercise the remedies in this Section 12.02, Buyer shall be permitted 11.2.2 (a) upon a Failure to disclose to any third party any Confidential Information Supply as is reasonably necessary a result of a Force Majeure event in connection accordance with such activities (subject to such third party agreeing in writing to be bound by the terms of Article 15 hereof), save and except for the direct labour (variable costs), fixed overhead costs and profit margins of the ManufacturerSection 12.10.

Failure to Supply. In Notwithstanding the provisions of Section 12.01, in the event that any of the following occur: : (a) Manufacturer Alba notifies Buyer in accordance with Ortho (pursuant to Section 4.03 12.01 or otherwise) that Manufacturer Alba will not be able to fulfill BuyerOrtho’s Purchase Order as requested by Buyer and which Purchase Order was requested in accordance with the terms herein (e.g., Buyer’s requested dates for delivery of Purchase Orders must comply with the requirements in Article 4 (except for those Purchase Orders that could not be completed as a result of Direct Supplier’s failure to supply as described in Section 4.03(a) ; Order; (b) Manufacturer fails to fulfill the Purchase Order in accordance with the terms herein; (c) Buyer Ortho has sent Manufacturer Alba a notice of termination in accordance with Section 8.01 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 8.02 any Products other than the OrthoSera Products within ninety (regardless 90) days of whether or not Manufacturer is attempting to correct such breach that triggered Buyer’s notice within Manufacturer’s thirty (30) day cure period); or (d) Manufacturer is otherwise unable or unwilling to supply Product that complies with the requirements herein in such quantities scheduled delivery date as Buyer shall request and in compliance with the delivery periods set forth in the applicable any Purchase Order order (whether due to the occurrence of a Force Majeure Event 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 (dc) are referred to as a “Failure to Supply”), then (i) immediately following such Failure to Supply Buyer 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, purchase use, sell make and have made Product from another 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; itself (iiwith no obligation or liability to Alba); (iii) Manufacturer Alba shall provide Buyer Ortho and such other manufacturer with assistance, as reasonably requested, in connection with such manufacturer’s or BuyerOrtho’s efforts to supply such Product to BuyerOrtho, 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 (iiiIV) Buyer for sake of clarity, Ortho shall have no obligation to purchase such ordered pay the Price (as adjusted) for any Product from Manufacturer for sale or distribution in the Territory or otherwise until any contractual obligations that Buyer has assumed supplied by Alba, less all reasonable costs incurred by Ortho in connection with producing the same or obtaining such substitute source of supply shall have terminated or if Buyer opts to manufacture internally, until Buyer can reasonably resume purchasing Product from Manufacturer without any additional cost to Buyer; activities set forth in this clauses; (iv) Buyer shall have no obligation to affirmatively terminate any such contractual arrangements or, if Buyer opted to manufacture Product internally, cease manufacturing internally prior to such time that Buyer could revert to Manufacturer without incurring any cost; and (v) Manufacturer Alba shall make available to Buyer Ortho or its designee access to all technical and proprietary materials, information information, techniques and techniques necessary or helpful Intellectual Property Rights of Alba for Buyer Ortho to procure required Raw Materials or Product produce or arrange an alternative supplier of Raw Materials or Product. Notwithstanding anything to the contrary contained in this Agreement, in the event that Buyer Ortho shall make or have made the Product, pursuant to this Section 12.02, Buyer 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 that Ortho shall purchase Product from another manufacturer or manufacture Product for itself pursuant to this Section 12.02 (other than as a result of a Force Majeure Event), save Alba shall be liable for all reasonable costs incurred by Ortho in connection with the activities set forth in clauses (i) through (v) above, including without limitation, costs for technical transfer, qualification, validation and 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 claim all direct damages and losses incurred (except for consequential damages). Notwithstanding the direct labour foregoing, if such inability, unwillingness or failure to supply Products which conform with the applicable Specifications within the delivery periods set forth herein occurs more than two (variable costs2) times in any calendar quarter (unless due to a Force Majeure Event), fixed overhead costs and profit margins such inability, unwillingness or failure shall be deemed a material breach of the Manufacturerthis Agreement.