Services, Manufacturing And Supply Agreement

Exhibit 10.1


SERVICES, MANUFACTURING AND SUPPLY AGREEMENT


This SERVICES, MANUFACTURING AND SUPPLY AGREEMENT (the "Agreement"), dated as of the 7th day of April, 2003 (the "Effective Date"), by and between EXACT Sciences Corporation ("EXACT"), a Delaware corporation doing business at 63 Great Road, Maynard, Massachusetts 01754; and Discovery Labware Inc. ("Discovery"), a wholly owned subsidiary of Becton Dickinson and Company ("Becton Dickinson"), doing business at 296 Concord Road, Billerica, MA 01821.


WHEREAS, EXACT owns and has developed proprietary technologies directed to, among other things, the recovery of DNA from biological samples and in particular for use in the diagnosis of colon cancer and is producing improvements, enhancements and inventions related to all of its technologies, including a proprietary device having [CONFIDENTIAL TREATMENT REQUESTED] /*/ components, that includes a treated membrane-like material,


WHEREAS, Becton Dickinson owns and has developed proprietary technologies and equipment directed to, among other things, manufacturing, tooling, molding, packaging, labeling, processes, equipment, know-how and methods, including but not limited to, molding of consumables, molds, tooling, core pins and attaching membrane and membrane-like materials to all types of objects or other materials, and is producing improvements, enhancements and inventions related to all of these proprietary technologies; and


WHEREAS , EXACT desires to engage the services of Discovery to use Becton Dickinson's proprietary technology to design, develop, use and deliver the tooling to manufacture and produce [CONFIDENTIAL TREATMENT REQUESTED] /*/ components of EXACT's proprietary consumable;


WHEREAS, EXACT desires Discovery to use Becton Dickinson's proprietary technologies to manufacture and produce the [CONFIDENTIAL TREATMENT REQUESTED]/*/ components of EXACT's proprietary consumable, for Discovery to attach a treated membrane material which is to be supplied by EXACT, or EXACT's designee, to one of these components, and for Discovery to supply to EXACT the completed proprietary consumable in a certain package and with a certain label, all in accordance with the Hybrigel Consumable Specifications; and


WHEREAS , Discovery is willing to provide services to EXACT to design, research and develop tooling to manufacture and produce the [CONFIDENTIAL TREATMENT REQUESTED]/*/ components of EXACT's proprietary consumable and to manufacture and produce the [CONFIDENTIAL TREATMENT REQUESTED]/*/ components of EXACT's proprietary consumable, to receive the treated membrane


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materials from EXACT, to use Becton Dickinson's proprietary technology to process and attach the treated membrane material to one of the [CONFIDENTIAL TREATMENT REQUESTED]/*/ components and to package and label EXACT's completed Hybrigel Consumable for supply to EXACT, in accordance with EXACT's Hybrigel Consumable Specifications.


NOW, THEREFORE, in consideration of the premises and the mutual promises and covenants contained below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:


ARTICLE 1: DEFINITIONS.


1.1 "Act" shall mean the Food, Drug and Cosmetic Act (21 U.S.C. a7 a7 301 et seq.) and the regulations promulgated thereunder.


1.2 "Affiliates" of a party as used herein shall mean any entity which, at any time during the Term of this Agreement, directly or indirectly, through one or more intermediaries, controls such party, is controlled by such party, or is under common control of such party, (including subsidiaries) and another entity, or is controlled by an entity that controls such party.


1.3 "Analyte Specific Reagent" shall have the meaning ascribed to it by 21 C.F.R. a7 809.30 and 864.4020(a), (B - class 1), to include a Class 1 designation.


1.4 "Discovery" shall mean Discovery Labware Inc.


1.5 "Discovery Bonding" shall mean the specific Discovery proprietary method developed by Discovery for affixing or attaching the Membrane to the Hybrigel Consumable.


1.6 "Discovery Certificate of Conformance" shall mean the certificate of analysis report in the form attached hereto as Appendix A setting forth the results of the quality control analyses performed on the Hybrigel Consumables by Discovery to confirm conformity to the Hybrigel Consumable Specifications.


1.7 "Discovery Technology and Equipment" shall mean all technology and equipment relating to manufacturing processes, techniques and methods, including but not limited to all molds, tooling, core pins, molding, packaging, labeling and attaching all types of materials, including but not limited to membrane materials and the like attached to all types of objects and materials, Discovery Bonding techniques, practices and methods, and any other intellectual property belonging to or licensed (other than as pursuant to this Agreement ) by Discovery or its Affiliates, whether or not patented, in any form, tangible or intangible, including, without limitation, all manufacturing specifications, mold specifications, all ideas, concepts, know-how, trade secrets, inventions, developments, discoveries, works of authorship, algorithms, systems, processes, methods, techniques, bonding methods, and research and technical information. Discovery Technology and Equipment does not mean or include EXACT Technology or EXACT Tooling.


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1.8 "EXACT" shall mean EXACT Sciences Corporation and its Affiliates, unless the context indicates otherwise.


1.9 "EXACT Certificate of Analysis" means the certificate of performance report in the form attached hereto as Appendix B setting forth the results of the quality control analyses performed on the Membranes by Exact or its designee to confirm conformity to the Membrane Specifications.


1.10 "EXACT Technology" shall mean the Hybrigel Consumable and technology, the purification of biological samples using the Hybrigel Consumable, and the diagnosis of disease using a Hybrigel Consumable, and any other EXACT intellectual property that was created, developed or otherwise acquired by or on behalf of EXACT as of the Effective Date of this Agreement, or developed or otherwise acquired by or on behalf of EXACT subsequent to the Effective Date of this Agreement, whether or not patented, in any form, tangible or intangible, including, without limitation, all specifications (including the Specifications in Appendix D of this Agreement), ideas, designs, concepts, know-how, trade secrets, inventions, developments, discoveries, works of authorship, formulae, algorithms, systems, processes, methods, techniques, consumables, research information, bonding methods, evaluations, studies, analytical results, assays, data, technical information, and samples. EXACT Technology does not mean or include the Discovery Technology and Equipment (including Discovery Bonding) and the EXACT Tooling.


1.11 "EXACT Tooling" shall mean the molds and core pins, necessary to manufacture and produce [CONFIDENTIAL TREATMENT REQUESTED]/*/ components of EXACT's Hybrigel Consumable as described in Phase I of the Manufacturing Plan included in Appendix C.


1.12 "FDA" means the United States Food and Drug Administration or any successor agency.


1.13 "GMP" shall mean the current good manufacturing practices and QSRs for Class 1 Analyte Specific Reagents promulgated from time to time by the FDA in accordance with the Act.


1.14 "Hybrigeld4 Consumable" shall mean the EXACT proprietary Hybrigeld4 Consumable as described in Appendix D of this Agreement.


1.15 "Hybrigel Consumable Specifications" shall mean the description, physical description and drawings, dimensions, materials, processes and testing and inspection information for the Hybrigeld4 Consumable as contained in Appendix D of this Agreement, excluding any Membrane information or specifications, and any labeling or packaging information or specifications and excluding any characteristic caused in whole or in part by the failure of the Membrane to meet the Membrane Specifications.


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1.16 "Manufacturing Plan", shall mean the milestones and parameters as set forth in Appendix C hereto for the design, development and use of the EXACT Tooling.


1.17 "MDR" shall mean medical device reporting promulgated by FDA, requiring event malfunction, serious injury and death to be reported to FDA.


1.18 "Membrane" shall mean the Hybrigel membrane in the form supplied by EXACT or EXACT's designee to Discovery.


1.19 "Membrane Specifications" shall mean the description, physical description and drawings, dimensions, materials, processes and testing and inspection information for the Membranes as contained in Appendix D of this Agreement.


1.20 "QSR" shall mean the Quality System Regulation as defined in 21 C.F.R. a7 820.


1.21 "Party" or "Parties" shall mean EXACT and/or Discovery, as the context requires.


1.22 "Reporting Period" means a three (3) month period ending January 31, April 30, July 31 and October 31 of each calendar year.


ARTICLE 2: SERVICES TO PERFORMED AND EVALUATION OF MEMBRANE


2.1 EXACT Tooling. Discovery shall design, research, develop, and, deliver to EXACT, the EXACT Tooling.


2.2 Discovery Point of Contact. Discovery's point of contact at EXACT is David Deems, Vice President of Product Development.


2.3 EXACT Point of Contact. EXACT's point of contact at Discovery is Blake S. Perkins, Marketing Manager, Drug Discovery.


2.4 Rights to the EXACT Tooling. Upon EXACT and Discovery's validation of the EXACT Tooling, Discovery shall and does hereby irrevocably grant and assign to EXACT the entire right, title and interest, in and to the EXACT Tooling. Discovery shall hold the EXACT Tooling at its facilities, as requested by EXACT, and Discovery shall at all times maintain adequate insurance to protect against risk of loss for the EXACT Tooling at Discovery's facilities.


2.5 Discovery agrees to use and operate the EXACT Tooling solely for the purposes of this Agreement.


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2.6 Delivery of the EXACT Tooling at Termination . In the event that this Agreement is to be terminated or expire, (i) Discovery shall pack the EXACT Tooling and ship it to an EXACT designated facility, so long as EXACT has met its payment obligations under Article 3 hereof. Discovery shall not be responsible for the implementation of the EXACT Tooling. Discovery agrees to provide EXACT with one (1) full time equivalent (FTE) person(s) for a time period of sixty (60) consecutive business days, such period not to exceed the day that is four (4) months from delivery of the EXACT Tooling to the EXACT designated facility, to support the implementation of the EXACT Tooling per EXACT's instructions and with a vendor of EXACT's choosing. The FTE shall work only during regular business hours. EXACT shall pay Discovery, on a prospective basis each month for work to be performed in the coming month, for the FTE's salary and all related time, material, travel and expenses and shall indemnify and hold harmless Discovery against any claims of the FTE based upon his or her work with EXACT. EXACT shall reimburse Discovery for the FTE's salary and all related time, material, travel and expenses, at rates that are then in effect for Discovery and the FTE. EXACT covenants that it will provide a safe working environment for the FTE, whether at its own facility or at that of a contractor, and that it will ensure that any facilities to which the FTE is sent will comply with all applicable health and safety and environmental regulations. EXACT assumes all risk of the FTE's presence at such facility and agrees to indemnify and hold harmless Discovery, it's employees, officers and directors and its Affiliates and their employees, officers and directors from and against any claims, damages, losses or liability resulting directly or indirectly from the FTE's presence at such facility and his or her work at such facility, other than as related to such FTE's gross negligence or misconduct. In addition, EXACT will maintain insurance adequate to cover any claims resulting from the FTE's presence at such facility and his or her work at such facility. EXACT agrees to assume full responsibility for any injury or death caused to the FTE, while the FTE is working at the EXACT designated facility, other than as related to such FTE's gross negligence or misconduct. EXACT agrees to provide Discovery's FTE with all safety and other protections required by law, including, without limitation, all Occupational Health and Safety Administration rules and regulations. The FTE shall not be required to execute any agreement, waiver or release which in any way purports to affect the legal rights or obligations of the FTE. If the FTE signs such an agreement, waiver or release, it shall be considered void and have no force and effect.


2.7 [CONFIDENTIAL TREATMENT REQUESTED]/*/. EXACT agrees [CONFIDENTIAL TREATMENT REQUESTED]/*/ any of the life sciences business entities listed below any [CONFIDENTIAL TREATMENT REQUESTED]/*/, and [CONFIDENTIAL TREATMENT REQUESTED]/*/ relating to the [CONFIDENTIAL TREATMENT REQUESTED]/*/ during the period from the [CONFIDENTIAL TREATMENT REQUESTED]/*/ through to and including [CONFIDENTIAL TREATMENT REQUESTED]/*/, unless Discovery is unable to [CONFIDENTIAL TREATMENT REQUESTED]/*/ as set forth herein, in which case this Agreement shall become [CONFIDENTIAL TREATMENT REQUESTED]/*/ pursuant to Section 3.9 below.


The life science business entities are [CONFIDENTIAL TREATMENT REQUESTED]/*/.


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2.8 Maintenance of EXACT Tooling . EXACT and Discovery agree that Discovery will provide, at no cost to EXACT, any maintenance that is necessary as a result of normal wear and tear while in Discovery's possession, as well as any other repairs that become necessary as a result of Discovery's negligence or breach of this Agreement. Any maintenance and repairs beyond that described above will be at EXACT's sole cost and expense. No repairs or maintenance, for which EXACT will be bearing the expense, will be conducted without EXACT's express prior written authorization.


2.9 New Tooling . EXACT agrees that should modifications to the EXACT Tooling or new tooling (collectively "New Tooling") be required in accordance with EXACT's request, EXACT shall bear all direct costs and expenses of such New Tooling. EXACT may request Discovery to design, manufacture or have manufactured New Tooling on its behalf. EXACT and Discovery agree to negotiate in good faith additional terms relating to the design and manufacture of New Tooling including the amendment of Section 3.8 to include provisions that allow for the purchase of Hybrigel Consumables relating to the New Tooling to [CONFIDENTIAL TREATMENT REQUESTED]/*/ and the [CONFIDENTIAL TREATMENT REQUESTED]/*/ as appropriate.


2.10 [CONFIDENTIAL TREATMENT REQUESTED]/*/ Additional EXACT Tooling . Should it become necessary to produce and use any EXACT Tooling in addition to the one set of molds referred to in Section 2.4 in order to produce amounts in [CONFIDENTIAL TREATMENT REQUESTED]/*/ (the "Additional EXACT Tooling") and satisfy Product Forecasts, the cost of such Additional EXACT Tooling will be borne by EXACT. Discovery agrees to use commercially reasonable efforts to provide EXACT with reasonable notice of the need to produce Additional EXACT Tooling based on the timing of the receipt of the Product Forecast for which such Additional EXACT Tooling would be required. EXACT may request Discovery to manufacture or have manufactured the Additional EXACT Tooling on its behalf and Discovery may accept or reject such request. If Discovery rejects EXACT's request, or if Discovery requires payment for the Additional EXACT Tooling in an amount in excess of 150% of the cost of the initial EXACT Tooling, then, so long as EXACT has [CONFIDENTIAL TREATMENT REQUESTED]/*/ EXACT may [CONFIDENTIAL TREATMENT REQUESTED]/*/.


2.11 Possible [CONFIDENTIAL TREATMENT REQUESTED]/*/ by Discovery. Discovery agrees in good faith to [CONFIDENTIAL TREATMENT REQUESTED]/*/ for Discovery of Discovery [CONFIDENTIAL TREATMENT REQUESTED]/*/ and to consider [CONFIDENTIAL TREATMENT REQUESTED]/*/ pursuant to which Discovery may [CONFIDENTIAL TREATMENT REQUESTED]/*/ and to discuss whether such [CONFIDENTIAL TREATMENT REQUESTED]/*/. In the event Discovery determines that it [CONFIDENTIAL TREATMENT REQUESTED]/*/ or other arrangement with [CONFIDENTIAL TREATMENT REQUESTED]/*/, then Discovery shall so notify EXACT, and may [CONFIDENTIAL TREATMENT REQUESTED]/*/ for EXACT'S review or consider any documentation provided by EXACT. This Section 2.11, shall not create any [CONFIDENTIAL TREATMENT REQUESTED]/*/ and is merely intended to serve as an


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expression of Discovery's current intentions, and under no circumstances will the [CONFIDENTIAL TREATMENT REQUESTED]/*/.


ARTICLE 3: MANUFACTURE; SUPPLY; AND DELIVERY.


3.1 Manufacture of Hybrigel Consumables . Upon validation of the EXACT Tooling, Discovery agrees to manufacture, package and label the Hybrigel Consumable for EXACT in accordance with the Hybrigel Consumable Specifications and will deliver the Hybrigel Consumables to a United States address for EXACT or EXACT's designee in accordance with the quantities and schedule set forth in any purchase order that has been delivered and accepted in accordance with the terms of this Agreement. Except and unless the parties mutually agree in writing otherwise, EXACT shall deliver to Discovery Membranes meeting the Membrane Specifications. EXACT shall deliver such Membranes to Discovery in the quantity and quality necessary for Discovery to fulfill its obligations under the Purchase Orders. Membranes shall be deemed of adequate quality if they are delivered in accordance with the Certificate of Analysis as described in Appendix B. Such Membranes will be supplied at no cost to Discovery, and solely for the purposes of carrying out Discovery's obligations under this Agreement. EXACT shall provide to Discovery the Membranes accompanied by an EXACT Certificate of Analysis confirming that the Membranes meet the Membrane Specifications. Discovery may reject any shipment of Membranes that is not accompanied by such Certificate of Analysis or that it determines does not meet the representations set forth in the Certificate of Analysis and shall notify EXACT in writing of the rejection and, and if applicable, the details regarding how the Membranes fail, in Discovery's opinion, to meet such representations. In the event of the failure of EXACT to deliver, or any material delays in EXACT's delivery of any Membranes or the failure of such Membranes to meet the Membrane Specifications, Discovery shall not be required to deliver the Hybrigel Consumables for which such Membranes were intended, Discovery shall not be deemed to have breached this Agreement, and the parties will discuss in good faith an alternative delivery schedule, if any. Discovery agrees that it will not produce the [CONFIDENTIAL TREATMENT REQUESTED]/*/ except in such lots as are reasonably necessary to meet EXACT's forecasts.


3.2 [CONFIDENTIAL TREATMENT REQUESTED]/*/. EXACT hereby agrees that, [CONFIDENTIAL TREATMENT REQUESTED]/*/, EXACT will [CONFIDENTIAL TREATMENT REQUESTED]/*/, except as specified in sections 3.9 and Article 9.


3.3 Supply of Membranes and Tooling . Discovery shall not be responsible for the costs of the Membranes, which shall be supplied by EXACT or EXACT's designee without charge to Discovery, or the costs, if any, of any Additional EXACT Tooling purchased by EXACT or any modifications thereto under this Agreement.


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3.4 Analyte Specific Reagents. EXACT shall provide to Discovery all documents as appropriate and necessary for Discovery to comply with all applicable governmental laws, requirements and regulations relating to manufacturing using Analyte Specific Reagents, including without limitation, compliance with the requirements under 21 C.F.R. a7 809.30 and 864.4020 and QSR requirements under 21 C.F.R. a7 820. Documents provided by EXACT pursuant to this section, as well as all label requirements, shall support a Class 1 designation. So long as (i) the conditions of this section 3.4 are met, and (ii) the components supplied to Discovery for use in connection with the Hybrigel Consumable meet Discovery's supplier qualifications as defined by 21 C.F.R. a7820 (and meet all current and future ASR Regulations, as promulgated), Discovery agrees that it will label the Hybrigel Consumable as an Analyte Specific Reagent.


3.5 Amendment of Manufacturing Plan and Specifications. The Hybrigel Consumable Specifications and Manufacturing Plan may be amended by the Parties from time to time; provided, however, that no change to the Manufacturing Plan or Hybrigel Consumable Specifications shall be effective or binding upon the Parties unless an amendment incorporating such change has been executed by the duly authorized representatives of the parties hereto. EXACT and Discovery agree that any such amendment shall include provisions that allow the purchase of Hybrigel Consumables manufactured in accordance with any changes in the Hybrigel Consumable Specifications and Manufacturing Plan to [CONFIDENTIAL TREATMENT REQUESTED]/*/ and the [CONFIDENTIAL TREATMENT REQUESTED]/*/ as appropriate.


3.6 Forecasts . EXACT's initial forecast by Reporting Period of the quantity of the Hybrigel Consumables that EXACT expects to purchase from Discovery during the first four Reporting Periods after the Effective Date, is provided in Appendix E. On or before the sixtieth (60th) day preceding the first day of each Reporting Period, subsequent to the first, EXACT shall submit a revised forecast by Reporting Period for the Hybrigel Consumables for the next consecutive four Reporting Periods. Discovery shall not be required to [CONFIDENTIAL TREATMENT REQUESTED]/*/ in any Reporting Period, unless EXACT has [CONFIDENTIAL TREATMENT REQUESTED]/*/, pursuant to section 3.7 below. To the extent Discovery cannot [CONFIDENTIAL TREATMENT REQUESTED]/*/, this Agreement shall [CONFIDENTIAL TREATMENT REQUESTED]/*/, in accordance with Section 3.7 below.


3.7 Purchase Orders and Supply. On or before the date that is thirty (30) days prior to the first day of the immediately upcoming Reporting Period, EXACT shall place orders for the Hybrigel Consumables by submitting written purchase orders to Discovery in the form attached hereto as Appendix F and specifying a quantity that is consistent with the requirements set forth herein (Discovery shall be entitled to reject any purchase order that is not provided to Discovery in accordance with the requirements of this Section 3.7). The Parties agree to the following purchase order requirements:


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3.7.1 No later than sixty (60) days prior to the beginning of each Reporting Period, EXACT shall provide Discovery with a rolling twelve-month forecast describing EXACT's anticipated Hybrigel Consumable needs;


3.7.2 No later than thirty (30) days prior to each immediately upcoming Reporting Period, EXACT shall submit purchase orders for such Reporting Period. The purchase orders that are submitted to Discovery shall not contain requests for Hybrigel Consumable amounts (a) [CONFIDENTIAL TREATMENT REQUESTED]/*/ submitted to Discovery for the immediately upcoming Reporting Period, or (b) [CONFIDENTIAL TREATMENT REQUESTED]/*/ in accordance with Paragraphs 3.7.3 or 3.7.4;


3.7.3 For Reporting Periods in which EXACT wishes Discovery to [CONFIDENTIAL TREATMENT REQUESTED]/*/ EXACT, in its rolling forecast to Discovery, shall [CONFIDENTIAL TREATMENT REQUESTED]/*/ to Discovery;


3.7.4 For Reporting Periods in which EXACT wishes Discovery to [CONFIDENTIAL TREATMENT REQUESTED]/*/ EXACT, in its rolling forecast to Discovery, shall [CONFIDENTIAL TREATMENT REQUESTED]/*/ to Discovery;


3.7.5 Discovery will commence delivery of products ordered pursuant to a purchase order meeting the requirements of this section 3.7 on the thirtieth (30) day following the beginning of the applicable Reporting Period. Purchase orders shall be submitted to the following facsimile number: 800-743-6200, attention: Discovery Labware, Inc., Manager Customer Service, with a confirmed receipt, and confirmed by mail to the following address: Discovery Labware, 2 Oak Park, Bedford, Massachusetts 01730, Attention: Customer Service.


Discovery shall be entitled to reject purchase orders not meeting the requirements of this section 3.7, so long as Discovery provides EXACT with written notice of such rejection within at least twenty (20) days of receipt of the applicable purchase order from EXACT. Discovery shall make reasonable business efforts to comply with unplanned changes in purchase orders but shall not be required to accept orders that do not meet the guidelines set forth in this section 3.7.


3.8 [CONFIDENTIAL TREATMENT REQUESTED]/*/ Provision . Except as otherwise provided herein, EXACT agrees to [CONFIDENTIAL TREATMENT REQUESTED]/*/ and Discovery agrees to [CONFIDENTIAL TREATMENT REQUESTED]/*/ in accordance with the terms of Section 3.7 [CONFIDENTIAL TREATMENT REQUESTED]/*/ during the period of time from [CONFIDENTIAL TREATMENT REQUESTED]/*/ through the earlier of the [CONFIDENTIAL TREATMENT REQUESTED]/*/ or [CONFIDENTIAL TREATMENT REQUESTED]/*/. During the period of time from [CONFIDENTIAL TREATMENT REQUESTED]/*/ through [CONFIDENTIAL TREATMENT REQUESTED]/*/ EXACT agrees to [CONFIDENTIAL TREATMENT


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REQUESTED]/*/, which shall be [CONFIDENTIAL TREATMENT REQUESTED]/*/.


3.8.1 If EXACT has not [CONFIDENTIAL TREATMENT REQUESTED]/*/ on or prior to [CONFIDENTIAL TREATMENT REQUESTED]/*/, EXACT shall [CONFIDENTIAL TREATMENT REQUESTED]/*/ on or prior to [CONFIDENTIAL TREATMENT REQUESTED]/*/ for the purchase of Hybrigel Consumables in accordance with the terms of this Agreement [CONFIDENTIAL TREATMENT REQUESTED]/*/ will be [CONFIDENTIAL TREATMENT REQUESTED]/*/ of Hybrigel Consumables.


[CONFIDENTIAL TREATMENT REQUESTED]/*/ If EXACT has not [CONFIDENTIAL TREATMENT REQUESTED]/*/ on or prior to the earlier of [CONFIDENTIAL TREATMENT REQUESTED]/*/ or [CONFIDENTIAL TREATMENT REQUESTED]/*/, EXACT shall, in full satisfaction of its obligations to Discovery hereunder, immediately [CONFIDENTIAL TREATMENT REQUESTED]/*/ will be [CONFIDENTIAL TREATMENT REQUESTED]/*/ relating to Reporting Periods subsequent to [CONFIDENTIAL TREATMENT REQUESTED]/*/ in the event the Agreement is renewed beyond such date. EXACT shall [CONFIDENTIAL TREATMENT REQUESTED]/*/ prior to the earlier of [CONFIDENTIAL TREATMENT REQUESTED]/*/ or [CONFIDENTIAL TREATMENT REQUESTED]/*/


3.8.3 If, other than (i) pursuant to Section 12.9, (ii) as a result of the failure of, or delay by, EXACT to deliver Membranes complying with the Specifications or (iii) as a result of breach of this Agreement on the part of EXACT((i)-(iii) above are collectively referred to herein as the "Contingencies"), Discovery is unable to deliver to EXACT for two Reporting Periods ...