{"id":42511,"date":"2015-09-17T11:25:58","date_gmt":"2015-09-17T16:25:58","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-legal\/contracts\/uncategorized\/manufacturing-and-supply-agreement-dendreon-corp-and-kirin.html"},"modified":"2015-09-17T11:25:58","modified_gmt":"2015-09-17T16:25:58","slug":"manufacturing-and-supply-agreement-dendreon-corp-and-kirin","status":"publish","type":"corporate_contracts","link":"https:\/\/corporate.findlaw.com\/contracts\/operations\/manufacturing-and-supply-agreement-dendreon-corp-and-kirin.html","title":{"rendered":"Manufacturing and Supply Agreement &#8211; Dendreon Corp. and Kirin Brewery Co. Ltd."},"content":{"rendered":"<pre>\n                       MANUFACTURING AND SUPPLY AGREEMENT\n\n                                    BETWEEN\n\n                              DENDREON CORPORATION\n\n                                      AND\n\n                            KIRIN BREWERY CO., LTD.\n                                        \n\n[ * ] = Certain confidential information contained in this document, marked by\nbrackets, has been omitted and filed separately  with the Securities and\nExchange Commission pursuant to Rule 406 of the Securities Act of 1933, as\namended.\n\n \n\n                                                              \n ARTICLE 1   DEFINITIONS.........................................    1\n       1.1   'Affiliate'.........................................    2\n       1.2   'Back-Up License'...................................    2\n       1.3   'Business Day'......................................    2\n       1.4   'Collaborative License Agreement'...................    2\n       1.5   'Component' or 'Components'.........................    2\n       1.6   'Controlled'........................................    2\n       1.7   'Dendreon Antigen'..................................    2\n       1.8   'Dendreon Component' or 'Dendreon Components'.......    2\n       1.9   'Dendreon Product'..................................    2\n      1.10   'Dendreon Technology'...............................    3\n      1.11   'Dendritic Cell'....................................    3\n      1.12   'Fully-Burdened Manufacturing Costs'................    3\n      1.13   'Information'.......................................    3\n      1.14   'Kirin Antigen'.....................................    3\n      1.15   'Kirin Component' or 'Kirin Components'.............    3\n      1.16   'Kirin Product'.....................................    3\n      1.17   'Licensed Dendreon Product'.........................    3\n      1.18   'Licensed Kirin Product'............................    3\n      1.19   'Manufacturing Know-How'............................    4\n      1.20   'Manufacturing Plan'................................    4\n      1.21   'Net Revenue'.......................................    4\n      1.22   'Patent'............................................    4\n      1.23   'Product'...........................................    4\n      1.24   'Purchaser'.........................................    4\n      1.25   'Reagent'...........................................    4\n      1.26   'Reasonable Efforts'................................    4\n      1.27   'Research and License Agreement'....................    5\n      1.28   'Regulatory Approval'...............................    5\n      1.29   'Separation Devices'................................    5\n      1.30   'Steering Committee'................................    5\n      1.31   'Sublicensee'.......................................    5\n\n\n[ * ] = Certain confidential information contained in this document, marked by\nbrackets, has been omitted and filed separately  with the Securities and\nExchange Commission pursuant to Rule 406 of the Securities Act of 1933, as\namended. \n\n                                       i\n\n \n\n                                                              \n      1.32   'Supplier'..........................................    5\n      1.33   'Supplier Patent'...................................    5\n      1.34   'Third Party'.......................................    5\n ARTICLE 2   SUPPLY FOR CLINICAL DEVELOPMENT.....................    5\n       2.1   Supply for Clinical Development.....................    5\n       2.2   Forecasts...........................................    6\n       2.3   Order Placement Procedure...........................    6\n       2.4   Delivery and Risk of Loss...........................    7\n       2.5   Acceptance and Rejection............................    7\n       2.6   Manufacturing Modifications.........................    8\n       2.7   Restrictions on Sale................................    8\n       2.8   Use of Separation Devices by Kirin Collaborators....    8\n ARTICLE 3   COMMERCIAL SUPPLY...................................    9\n       3.1   Commercial Supply...................................    9\n       3.2   Preparation.........................................    9\n       3.3   Forecasts...........................................    9\n       3.4   Order Placement Procedure...........................    9\n       3.5   Inventory...........................................   10\n       3.6   Amendments..........................................   10\n       3.7   Resolution of Supply Problems.......................   11\n       3.8   Acceptance and Rejection............................   12\n ARTICLE 4   REGULATORY REQUIREMENTS.............................   13\n       4.1   Manufacturing Facilities, Equipment and Licenses....   13\n       4.2   Manufacturing Regulatory Matters....................   13\n       4.3   Product Recall Procedures...........................   14\n       4.4   Documentation.......................................   15\n ARTICLE 5   FINANCIAL OBLIGATIONS...............................   15\n       5.1   Purchase Prices.....................................   15\n       5.2   Audit...............................................   16\n       5.3   Financing the Development of Dendreon Products......   16\n ARTICLE 6   CONFIDENTIALITY.....................................   17\n       6.1   Confidentiality; Exceptions.........................   17\n\n\n[ * ] = Certain confidential information contained in this document, marked by\nbrackets, has been omitted and filed separately  with the Securities and\nExchange Commission pursuant to Rule 406 of the Securities Act of 1933, as\namended.\n \n\n                                       ii\n\n \n\n                                                              \n       6.2   Authorized Disclosure...............................   17\n       6.3   Survival............................................   17\n ARTICLE 7   INTELLECTUAL PROPERTY...............................   18\n ARTICLE 8   REPRESENTATIONS AND WARRANTIES......................   18\n       8.1   General.............................................   18\n       8.2   Component Warranty..................................   18\n       8.3   Warranty Disclaimer.................................   19\n ARTICLE 9   TERM AND TERMINATION................................   19\n       9.1   Term................................................   19\n       9.2   Termination.........................................   19\n       9.3   Surviving Obligations...............................   19\n       9.4   Termination Without Cause...........................   19\nARTICLE 10   INDEMNIFICATION.....................................   19\n      10.1   Indemnification by Dendreon.........................   20\n      10.2   Indemnification by Kirin............................   20\n      10.3   Indemnity Procedure.................................   21\nARTICLE 11   MISCELLANEOUS.......................................   21\n      11.1   Assignment..........................................   21\n      11.2   Retained Rights.....................................   21\n      11.3   Force Majeure.......................................   21\n      11.4   Further Actions.....................................   22\n      11.5   No Trademark Rights.................................   22\n      11.6   Notices.............................................   22\n      11.7   Dispute Resolution..................................   23\n      11.8   Waiver..............................................   23\n      11.9   Severability........................................   23\n     11.10   Ambiguities.........................................   23\n     11.11   Entire Agreement....................................   23\n     11.12   Headings............................................   23\n \n\n[ * ] = Certain confidential information contained in this document, marked by\nbrackets, has been omitted and filed separately  with the Securities and\nExchange Commission pursuant to Rule 406 of the Securities Act of 1933, as\namended.\n\n                                      iii\n\n \nCERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,\nHAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                                                   EXHIBIT 10.17\n\n                       MANUFACTURING AND SUPPLY AGREEMENT\n\n     This Manufacturing and Supply Agreement (the 'Agreement') is made and\nentered into effective as of July 27, 1999 (the 'Effective Date') by and between\nDendreon Corporation, a Delaware corporation having its principal place of\nbusiness at 3005 1st Avenue, Seattle, Washington, U.S.A. ('Dendreon'), and Kirin\nBrewery Co., Ltd., a corporation organized and existing under the laws of Japan\nhaving its principal place of business at 10-1, Shinkawa 2-chome, Chuo-ku,\nTokyo, Japan ('Kirin').  Dendreon and Kirin may be referred to herein\ncollectively as the 'Parties' or individually as a 'Party.'\n\n                                    RECITALS\n\n     A.  Dendreon has developed and owns certain proprietary technology relating\nto the manufacture of devices, reagents and proprietary antigens necessary for\nDendreon Products and Kirin Products.\n\n     B.  Kirin has developed and owns certain proprietary technology relating to\nthe manufacture of certain proprietary antigens and other proprietary components\nnecessary for Kirin Products and Dendreon Products.\n\n     C.  Kirin desires to purchase from Dendreon certain of its devices,\nreagents and certain of its proprietary antigens from Dendreon for use in\nclinical trials and commercialization of Kirin Products and Licensed Dendreon\nProducts, and Dendreon is willing to supply Kirin with such devices, reagents\nand antigens for such uses.\n\n     D.  Dendreon desires to purchase from Kirin certain components necessary\nfor making Licensed Kirin Products for use in clinical trials and\ncommercialization of Licensed Kirin Products and Dendreon Products, and Kirin is\nwilling to provide Dendreon with Kirin proprietary antigens and other Kirin\nproprietary components and certain Dendreon Components, if applicable, necessary\nfor Licensed Kirin Products and Dendreon Products for such use.\n\n     E.  The Parties contemplate that Dendreon may supply Kirin with commercial\nquantities of devices, reagents and Dendreon proprietary antigens, and Kirin may\nsupply Dendreon with commercial quantities of Kirin proprietary antigens and\nother Kirin proprietary components, in the event marketing approval is obtained\nfor any Products, in which case the Parties shall negotiate appropriate\namendments to this Agreement.\n\n     F.  The Parties contemplate that Dendreon may license Kirin to manufacture\ndevices, reagents and Dendreon proprietary antigens, and Kirin may license\nDendreon to manufacture Kirin components, necessary for making Products.\n\n     Now, therefore, the Parties agree as follows:\n\n \n                                   ARTICLE 1\n\n                                  DEFINITIONS\n\n\nThe following capitalized terms shall have the following meanings when used in\nthis Agreement.\n\n      1.1  'Affiliate' means, with respect to a particular Party, a person,\ncorporation or other entity that, directly or indirectly, through one or more\nintermediaries, controls, is controlled by or is under common control with such\nParty. For the purposes of this definition, 'control' means the direct or\nindirect ownership by a Party of at least fifty percent (50%) of the outstanding\nvoting securities of the controlled entity; provided, that in any country where\nthe law does not permit foreign equity ownership of at least fifty percent\n(50%), then with respect to corporations organized under such country's laws,\n'control' shall mean the direct or indirect ownership by a Party of outstanding\nvoting securities of such corporation at the maximum amount permitted by the law\nof such country.\n\n      1.2  'Back-Up License' shall have the meaning set forth in Section 3.7(c).\n\n      1.3  'Business Day' means any day that is not a Saturday, Sunday or other\nday on which (a) banks in the State of Washington are authorized or required to\nclose for the purposes of any action to be taken by or any notice to be provided\nto Dendreon, or (b) the banks in Japan are authorized or required to close for\nthe purposes of any action to be taken by or any notice to be provided to Kirin.\n\n      1.4  'Collaborative License Agreement' mean the Agreement by and between\nthe Parties dated December 10, 1998.\n\n      1.5  'Component' or 'Components' shall mean either a Kirin Component or a\nDendreon Component, depending upon the context of the applicable Section and the\nParty to which such section then applies.\n\n      1.6  'Controlled' means, with respect to a particular item, material, or\nintellectual property right, that a Party owns or has a license under such item,\nmaterial or intellectual property right and has the ability to grant to the\nother Party access to and\/or a license or sublicense under such item, material\nor intellectual property right without violating the terms of any agreement or\nother arrangement with, or the rights of, any Third Party.\n\n      1.7  'Dendreon Antigen' means an antigen that is claimed by a patent or is\notherwise covered by intellectual property rights that are Controlled by\nDendreon.\n\n      1.8  'Dendreon Component' or 'Dendreon Components' mean a Separation\nDevice, Reagent or Dendreon Antigen, or any combination thereof, other than a\ncombination which comprises a Dendreon Product.\n\n      1.9  'Dendreon Product' means: (a) any therapeutic product comprising\nDendritic Cells that have been activated or loaded with a specific antigen,\nengineered antigen or antigen gene, (including without limitation Dendreon\nAntigen), for use in human therapy by infusion into a patient, which product has\nbeen developed by Dendreon based on the Dendreon Technology; or (b) any service\nprovided by or on behalf of Dendreon to a patient that utilizes the\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       2\n\n \nDendreon Technology and involves isolation or preparation of Dendritic Cells,\nactivation or loading with specific antigen, engineered antigen or antigen gene,\n(including without limitation Dendreon Antigen), and infusion of such activated\nor antigen loaded Dendritic Cells into a patient. Further, the Parties may agree\nin writing to amend and extend the definition of Dendreon Product as provided in\nSection 5.8 of the Collaborative License Agreement.\n\n     1.10  'Dendreon Technology' means the Dendreon Know-How, the Dendreon\nImprovements and the Dendreon Patents, (as such terms are defined in the\nCollaborative License Agreement) either collectively or any part thereof.\n\n     1.11  'Dendritic Cell' means a human dendritic cell or other antigen-\npresenting cell or other cells from which dendritic cells can be derived.\n\n     1.12  'Fully-Burdened Manufacturing Costs' means the actual fully burdened\ncosts and expenses of manufacturing a particular Component, including without\nlimitation the costs of all raw materials and labor (including all allocable\nbenefits) used or consumed in such manufacture, Third Party contract\nmanufacturing costs, packaging costs and expenses, all quality assurance and\nquality control related expenses, all overhead amounts allocable to such\nmanufacturing (including without limitation appropriately amortized capital\nequipment costs), all royalty amounts payable by Supplier to any Third Party\nbased upon the manufacture of such Component, and all amounts related to failed\nproduction units or yield losses, all the foregoing as calculated in accordance\nwith (i) U.S. generally accepted accounting principles consistently applied for\nmanufacture of Components by Dendreon and (ii) Japan's generally accepted\naccounting principles consistently applied for manufacture of Components by\nKirin.\n\n     1.13  'Information' means any and all information and data of any kind,\nincluding without limitation techniques, inventions, practices, methods,\nknowledge, know-how, skill, experience, test data (including pharmacological,\ntoxicological and clinical test data), analytical and quality control data,\nmarketing, cost, sales and manufacturing data and descriptions, compositions,\nand assays.\n\n     1.14  'Kirin Antigen' means an antigen that is claimed by a patent or is\notherwise covered by intellectual property rights that are Controlled by Kirin.\n\n     1.15  'Kirin Component' or 'Kirin Components' shall mean any Kirin Antigen\nor any other Kirin proprietary component of a Kirin Product, and any combination\nthereof, that Dendreon is either unable to prepare or generally does not prepare\nfor Kirin or for itself.\n\n     1.16  'Kirin Product' means: (a) any therapeutic product developed by or on\nbehalf of Kirin based on, derived from or incorporating the Dendreon Technology\nthat comprises Dendritic Cells that have been activated or loaded with a\nspecific antigen, engineered antigen or antigen gene, (including without\nlimitation a Kirin Antigen), for use in human therapy by infusion into a\npatient; or (b) any service provided by or on behalf of Kirin to a patient that\ninvolves isolation or preparation of Dendritic Cells, activation or loading of a\nspecific antigen, engineered antigen or antigen gene, (including without\nlimitation a Kirin Antigen), and infusion of such activated or antigen loaded\nDendritic Cells into a patient, wherein such service is based on, utilizes,\ncomprises or is derived from the Dendreon Technology. The Parties may agree in\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       3\n\n \nwriting to amend and extend the definition of Kirin Product as provided in\nSection 5.8 of the Collaborative License Agreement.\n\n     1.17   'Licensed Dendreon Product' shall have the meaning set forth in\nSection 2.3(b) of the Collaborative License Agreement.\n\n     1.18   'Licensed Kirin Product' shall have the meaning set forth in Section\n2.4(b) of the Collaborative License Agreement.\n\n     1.19   'Manufacturing Know-How' means all Information other than Patents\nnecessary for the manufacture of a Kirin Antigen or Dendreon Antigen which is\nsubject to the Back-Up License.\n\n     1.20   'Manufacturing Plan' shall mean the plan prepared by the Supplier\nand delivered to the Purchaser for its review and approval, in good faith, which\nplan details the Supplier's manufacturing plan for achieving manufacture of the\nComponents at levels at least equal to the Purchaser's forecasted orders for the\nfirst year after commercial launch of the first Kirin Product or Dendreon\nProduct, as applicable.\n\n     1.21   'Net Revenue' means the total revenue received by a Party for sale\nor other disposition of a Product by such Party or an Affiliate or Sublicensee\nof such Party to a Third Party less the following to the extent actually\nincurred or allowed with respect to such sale or disposition: (i) reasonable\ncosts paid, if any, by the Party to a Third Party on account of apheresis\nperformed as part of or in association with the Product; (ii) discounts,\nincluding cash discounts, or rebates, retroactive price reductions or allowances\nactually allowed or granted from the billed amount; (iii) credits or allowances\nactually granted upon claims, rejections or returns of Products, including\nrecalls, regardless of the Party requesting such; (iv) freight, postage,\nshipping and insurance charges paid for delivery of Product, to the extent\nbilled; and (v) taxes, duties or other governmental charges levied on or\nmeasured by the billing amount when included in billing, as adjusted for rebates\nand refunds; provided, however, that with respect to sales of a particular Kirin\nProduct or Licensed Dendreon Product by Kirin or its Affiliate or Sublicensee in\nJapan, the 'total revenue received', as set forth above in the first line of\nthis definition, shall not in any event be less than the NHI Price established\nfor insurance reimbursement of Single Treatment (as defined in the Collaborative\nLicense Agreement), less the average amount charged by the particular hospital\npurchaser of such Product for the same number of apheresis services and infusion\nservices needed for and performed for Single Treatment (as defined in the\nCollaborative License Agreement) where such averages are calculated including\nall apheresis services or infusion services, as applicable, that were performed\nfor any purpose during the applicable period.\n\n     1.22   'Patent' means (i) a valid and enforceable patent, including any\nextension, registration, confirmation, reissue, re-examination or renewal\nthereof; and (ii) to the extent valid and enforceable rights are granted by a\ngovernmental authority thereunder, a patent application.\n\n     1.23   'Product' means a Kirin Product or a Dendreon Product.\n\n     1.24   'Purchaser' shall mean the Party purchasing Components from the\nother Party to the Agreement, as applicable, in the applicable section.\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       4\n\n \n     1.25   'Reagent' means, with respect to a particular Licensed Dendreon\nProduct, any proprietary reagent of Dendreon (excluding any reagents contained\nin a Separation Device) that is required for commercial manufacture and\/or use\nof such Licensed Dendreon Product.\n\n     1.26   'Reasonable Efforts' shall mean efforts and resources commonly used\nin the research-based pharmaceutical industry for the research, development and\ncommercialization of a product at a similar stage in its product life taking\ninto account the establishment of the product in the marketplace, the\ncompetitiveness of the marketplace, the proprietary position of the product, the\nregulatory structure involved, the profitability of the product and other\nrelevant factors.\n\n     1.27   'Research and License Agreement' shall mean the Research and License\nAgreement by and between the Parties dated as of February 1, 1999.\n\n     1.28   'Regulatory Approval' means any approvals, licenses, registrations\nor authorizations of any federal, state or local regulatory agency, department,\nbureau or other government entity, necessary for the manufacture, use, storage,\nimport, transport or sale of Products in a regulatory jurisdiction.\n\n     1.29   'Separation Devices' means any Dendreon device, including all\ncontainers and proprietary reagents comprising such device, that is intended for\nuse by Dendreon and its licensees for the isolation and purification of\nDendritic Cells for use in human therapy by activation or loading with specific\nantigen, engineered antigen or antigen gene, and infusion into a patient.\n\n     1.30   'Steering Committee' shall have the meaning set forth in Section 3.1\nof the Collaborative License Agreement.\n\n     1.31   'Sublicensee' shall mean any Third Party expressly licensed by a\nParty to make and sell one or more Products. A Sublicensee shall not include\ndistributors or sales agents that do no more than purchase and resell finished\nProducts on behalf of a Party.\n\n     1.32   'Supplier' shall mean the Party supplying Components to the other\nParty to the Agreement, its Affiliates or Sublicensees, as applicable, in the\napplicable section.\n\n     1.33   'Supplier Patent' shall mean any Patent Controlled by the Supplier\nduring the term of the Agreement.\n\n     1.34   'Third Party' means any entity other than Dendreon or Kirin or an\nAffiliate of Dendreon or Kirin.\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       5\n\n \n                                   ARTICLE 2\n\n                        SUPPLY FOR CLINICAL DEVELOPMENT\n\n\n      2.1  Supply for Clinical Development.\n\n           (a)  Subject to the terms of this Agreement and the Collaborative\nLicense Agreement, Kirin agrees to purchase from Dendreon, and Dendreon agrees\nto sell to Kirin, such Separation Devices and Reagents as Kirin requires to\nconduct clinical development of Kirin Products and\/or Licensed Dendreon Products\nin the Kirin Territory.\n\n           (b)  Subject to the terms of this Agreement and the Collaborative\nLicense Agreement, Kirin agrees to purchase from Dendreon, and Dendreon agrees\nto sell to Kirin, such quantities of Dendreon Antigen as Kirin requires to\nconduct clinical development of Licensed Dendreon Products in the Kirin\nTerritory, to the extent such Dendreon Antigen is reasonably available to\nDendreon.\n\n           (c)  Subject to the terms of this Agreement and the Collaborative\nLicense Agreement, Dendreon agrees to purchase from Kirin, and Kirin agrees to\nsell to Dendreon, such quantities of Kirin Components as Dendreon requires to\nconduct clinical development of Licensed Kirin products and Dendreon Products in\nthe Dendreon Territory, to the extent such Kirin Components are reasonably\navailable to Kirin.\n\n     2.2   Forecasts.    A reasonable period prior to the first expected order\nhereunder by the Purchaser of Components (at least six (6) months if possible),\nPurchaser shall provide the Supplier with a good faith written estimate of its\nexpected requirements, on a per quarter basis, for all such Components for the\nfirst two (2) years after such first order.  Commencing three (3) months before\nthe first expected order, Purchaser shall provide Supplier with quarterly\nrolling twelve (12) month forecasts for its expected orders for Components to be\nordered during each quarter during such period, with detail on each specific\nComponent and quantities to be ordered.  An updated forecast will be provided to\nSupplier within the first three (3) Business Days of each subsequent calendar\nquarter.  In each such forecast provided to Supplier as required herein (after\nthe first such rolling forecast), the forecast for the calendar quarter in which\nsuch forecast is delivered shall constitute a binding commitment of Purchaser\nand\/or its Affiliates to submit purchase orders for not less than one hundred\npercent (100%) of the amounts listed in such forecast during such quarter.\nFurther, such binding forecast for such quarter may not deviate by more than\ntwenty-five percent (25%) from the amount forecasted to be ordered during such\nquarter in the most recent previous forecast provided to Supplier.\n\n     2.3   Order Placement Procedure.    The Purchaser shall place orders for\nComponents to be supplied under the Agreement on Purchaser's standard English-\nlanguage purchase order form, specifying the quantity of each type of Component\nordered and the requested delivery date, which shall not in any event be longer\nthan one hundred and twenty (120) days from the date of such purchase order;\nprovided, however, that if due to complications and lead time for a particular\nComponent (such as antigen) the Supplier of such Component requires a delivery\nlead time for manufacture of such Component greater than one hundred twenty days\n(120) from the date of such purchase order, the Parties shall negotiate in good\nfaith a reasonable delivery date for such Component, not to be greater than one\nhundred and eighty (180) days from the date of\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       6\n\n \nthe purchase order. Supplier shall not be obligated to deliver Components\nordered prior to sixty (60) days after the applicable order is placed; however,\nSupplier agrees that it will use Reasonable Efforts to meet any earlier delivery\ndate reasonably requested by Purchaser. To the extent any purchase order,\ninvoice or acknowledgment form used by Supplier or Purchaser contains any\nprovisions additional or contrary to the provisions of this Agreement, such\nadditional or contrary provision shall have no force or effect and the terms of\nthis Agreement shall control. In addition, all such orders shall comply with the\nother requirements of this Article 2. The total amount of Components ordered by\nPurchaser during a particular calendar quarter shall not in any event be less\nthan one hundred percent (100%) of the amount of each such Component that was\nforecasted to be ordered for such quarter in the most recent forecast provided\nto Supplier, as set forth in Section 2.2 above, unless Supplier otherwise agrees\nin writing. In addition, Supplier shall not be obligated to supply any amounts\nin such order that are in excess of one hundred ten percent (110%) of the amount\nof the particular Component that was forecasted in the most recent binding\nforecast to be ordered for such quarter; however, Supplier agrees that it will\nuse Reasonable Efforts to supply such additional amounts. The Supplier shall use\nReasonable Efforts to deliver the Components ordered in compliance with this\nArticle 2. The Supplier shall immediately notify Purchaser in writing if\nSupplier determines that Supplier will not be able to supply a material amount\nof the most recent orders and\/or forecasts of orders for any Component. Shipment\nand delivery of Components ordered hereunder shall be in accordance with Section\n2.4.\n\n     2.4  Delivery and Risk of Loss.\n\n          (a)  Delivery of Dendreon Components ordered hereunder by Kirin shall\nbe by FCA Dendreon's actual manufacturing facility for such Components. 'FCA'\nshall be construed in accordance with INCOTERMS 1990 of the International\nChamber of Commerce. At Kirin's request and cost, Dendreon shall arrange\nshipping to specified Kirin locations. Delivered Dendreon Components shall be\nappropriately packaged by Dendreon, at Dendreon's expense, for export shipment.\n\n          (b)  Delivery of Kirin Components (and any Dendreon Components, if\napplicable) ordered hereunder by Dendreon shall be by FCA Kirin's actual\nmanufacturing facility for such Components. 'FCA' shall be construed in\naccordance with INCOTERMS 1990 of the International Chamber of Commerce. At\nDendreon's request and cost, Kirin shall arrange shipping to specified Dendreon\nlocations. Delivered Kirin Components shall be appropriately packaged by Kirin,\nat Kirin's expense, for export shipment.\n\n     2.5  Acceptance and Rejection. Purchaser shall have the right to test at\nits expense, using testing procedures agreed upon by the Parties and set forth\nin the specifications for the applicable Component, a portion of each shipment\nof Components to confirm that such shipment meets the applicable specifications.\nWhere it is required by local regulations, further testing on importation in\naccordance with the applicable specifications shall be carried out by Purchaser.\nIf Purchaser rejects in whole or in part any nonconforming shipment of\nComponents, Purchaser shall provide Supplier written notice of such rejection no\nlater than thirty (30) days after receipt of such shipment of Components. If\nPurchaser fails to provide Supplier with such notice of rejection within such\nthirty (30) day inspection period, Purchaser shall be deemed to have accepted\nthe applicable shipment of Components. If Supplier agrees with Purchaser's\ndetermination that a shipment of Components does not comply with applicable\nspecifications,\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       7\n\n \nSupplier shall use Reasonable Efforts to replace the nonconforming Components,\nat no additional cost to Purchaser. If Supplier reasonably disputes Purchaser's\nconclusion that such Components do not meet the applicable specifications,\nSupplier shall use Reasonable Efforts to replace such shipment of Components to\nPurchaser, at Purchaser's expense. If Supplier disagrees with Purchaser's\ndetermination that the rejected shipment did not meet the applicable\nspecifications, a sample of the rejected shipment shall be submitted to an\nindependent, qualified Third Party laboratory that is mutually acceptable and\nselected by the Parties promptly in good faith. Such laboratory shall determine\nwhether the rejected Components meet the applicable specifications, and such\nlaboratory's determination shall be final and determinative for purposes of this\nAgreement. The Party against whom the laboratory rules shall bear all costs of\nthe laboratory testing. If the laboratory rules that the shipment of Components\nfailed to meet the applicable specifications, then at Purchaser's choice, the\nprice paid by Purchaser for such nonconforming shipment shall be reimbursed to\nPurchaser (provided Purchaser paid for such shipment) or Components meeting the\napplicable specifications shall be shipped. If the laboratory rules that the\nComponents do not meet the applicable specifications, and if Supplier is unable\nto produce conforming Components, any sums actually paid therefore shall be\nrefunded to Purchaser with interest. At such time, the Parties will discuss in\ngood faith potential solutions to the supply problem. If the laboratory rules\nthe rejected shipment of Components met the applicable specifications, then\nPurchaser shall accept such shipment (including all costs of shipping and\ninsurance). Shipments of Components not meeting the applicable specifications\nmay, at Supplier's option and expense, be returned to Supplier or destroyed by\nPurchaser. If Supplier has acknowledged in writing that it is unable to produce\nconforming Components, any sums actually paid therefor will be refunded. The\nremedy of replacement or refund is available only if such nonconformance was not\ncaused by Purchaser's misuse, unauthorized modifications, neglect, improper\ntesting or improper storage, including without limitation storage at\ninappropriate temperatures, of such shipment of Components.\n\n     2.6  Manufacturing Modifications. If the laws of a country require\nSupplier's established specifications for a particular Component or Components\nto be modified in order for Purchaser to obtain Regulatory Approval of a Product\nin such country, Purchaser will submit the matter to the Steering Committee for\ndiscussion and proposed resolution. The Parties agree to negotiate in good faith\nany proposed modifications to the specifications for such Component or\nComponents for such Products proposed by the Steering Committee. Any such\nresolution of the Steering Committee must be agreed in writing by the Parties.\n\n     2.7  Restrictions on Sale.  Kirin and its Affiliates shall not resell the\nSeparation Devices purchased pursuant to this Article 2 except as part of a\nKirin Product or a Licensed Dendreon Product, and shall not use Separation\nDevices, Reagents or Dendreon Antigen for any purpose other than those purposes\npermitted in this Agreement, the Collaborative License Agreement or the Research\nand License Agreement. Dendreon shall retain all rights to manufacture or have\nmanufactured the Separation Devices, Reagents and Dendreon Antigens. Dendreon\nand its Affiliates shall not use Kirin Antigen for any purpose other than those\npurposes permitted in this Agreement, the Collaborative License Agreement or the\nResearch and License Agreement.\n\n     2.8  Use of Separation Devices by Kirin Collaborators. With Dendreon's\nprior written approval, which may be withheld for any reason, Kirin may provide\ncertain academic or medical doctor collaborators with a limited number of\nSeparation Devices solely for use by such \n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       8\n\n \nindividuals in research and development purposes in the Field; provided,\nhowever, that before any such delivery Kirin shall require such collaborator:\n(i) to be appropriately trained in the use of the Separation Devices, (ii) to\nshare the results of any and all research and development performed using the\nSeparation Devices with Kirin and Dendreon; (iii) not to sell, distribute or\notherwise provide such Separation Devices to Third Parties; and (iv) unless such\nantigen is within the public domain, to grant Dendreon an option to license any\nspecific antigen, engineered antigen or antigen gene used or developed in\nconjunction with the use of the Separation Devices. Except as explicitly\nprovided in this Agreement, Kirin obtains no license or rights to make or to\npractice any of the Dendreon Technology to make Separation Devices, Reagents or\nany other devices or products for use in the isolation or purification of\nDendritic Cells or any other cells. Notwithstanding anything else in this\nAgreement, Kirin may use Separation Devices to isolate Dendritic Cells only as\npart of preparing a Kirin Product or Licensed Dendreon Product or performing a\nservice comprising a Kirin Product or Licensed Dendreon Product, or with\nDendreon's prior written consent, as provided in this Section 2.8.\n\n                                   ARTICLE 3\n\n                               COMMERCIAL SUPPLY\n\n     3.1  Commercial Supply.  Subject to the other terms of this Agreement,\nDendreon agrees to provide Kirin, its Affiliates and Sublicensees with their\ncommercial requirements of Separation Devices, Reagents and Dendreon Antigens\nnecessary for use in manufacturing or using Kirin Products or Licensed Dendreon\nProducts for which Regulatory Approval has been obtained in the Kirin Territory.\n\n     3.2  Preparation.  At such time after the Effective Date that Supplier has\nprepared the Manufacturing Plan, but no later than one hundred and twenty (120)\ndays before the commercial launch of the first Kirin Product or Dendreon\nProduct, as applicable, Supplier shall provide to Purchaser such Information in\nSupplier's control relating to lead times Supplier requires to achieve\nmanufacture of Components on a commercial scale hereunder, necessary to\ndetermine appropriate procedures and mechanisms for providing to Supplier\nforecasts of Purchaser's, its Affiliates' and Sublicensees' requirements for\nComponents to be ordered and purchased hereunder, and for ordering such\nrequirements. The Purchaser shall review such Information promptly after\nreceipt, and appropriate representatives from Purchaser and Supplier shall then\nmeet to determine the appropriate forecasting, ordering and inventory mechanisms\nthat will be used by the Parties for ordering and supplying the commercial\nrequirements of Components hereunder. Such forecasting, ordering and inventory\nmechanisms shall be consistent with the terms of this Article 3 and shall be set\nforth in a writing, and upon mutual execution of such writing by the Parties,\nsuch mechanisms (the 'Supply Procedures') shall become part of this Agreement.\n\n     3.3  Forecasts.  With respect to the forecasting mechanism, such Supply\nProcedures shall provide:  (a) that within an agreed period of time prior to the\nfirst expected Regulatory Approval of a Product, Purchaser shall provide a good\nfaith estimate of its expected requirements, on a per quarter basis, for each\nparticular Component which is part of such Product to be ordered, for an agreed\nperiod before and an agreed period after the launch of such Product; (b) as of\nan agreed time before the first expected Regulatory Approval of a particular\nProduct, Purchaser shall provide Supplier a rolling twelve (12) month forecast\nfor Purchaser's expected\n\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       9\n\n \norders for each particular Component during each month during such twelve (12)\nmonth period; (c) Purchaser shall provide Supplier updated forecasts for\nexpected orders of Components at agreed intervals of time; (d) that in each\nforecast provided, the forecasted orders for an agreed time period for each\nforecasted Component shall constitute binding orders by Purchaser for such\nComponents, to be placed during such agreed time period; and (e) that forecasted\norders for each Component in a particular forecast delivered to Supplier may not\ndeviate by more than twenty-five percent (25%) from the forecast for orders for\nsuch Components in the most recent previous forecast submitted to Supplier. The\nParties further agree that if a Party determines that the foregoing forecasting\nmechanisms are inappropriate given the then-existing manufacturing and supply\ncircumstances for any Component, the Parties will discuss and agree in good\nfaith on appropriate written amendments to the forecasting mechanisms for such\nComponent.\n\n     3.4  Order Placement Procedure.  With respect to the ordering mechanism,\nsuch Supply Procedures shall provide: (a) that Purchaser shall place orders for\nComponents to be supplied under the Agreement on Purchaser's standard purchase\norder form, specifying the quantity of each specific Component ordered and the\nrequested delivery date, which shall not in any event be sooner or later than\nagreed time period(s) from the date of such purchase order; (b) that to the\nextent any purchase order, invoice or acknowledgment form used by Purchaser\ncontains any provisions additional or contrary to the provisions of this\nAgreement, such additional or contrary provision shall have no force or effect\nand the terms of this Agreement shall control; (c) that Supplier shall not be\nobligated to supply any amounts of a particular Component in such order more\nthan an agreed percentage of the unit quantity of such Component specified in\nthe binding forecast for the applicable time period; (d) that Purchaser's orders\nfor a Component may not be less than an agreed percentage of the binding\nforecast for such Component for the applicable time period; and (e) that\nSupplier will use Reasonable Efforts to provide additional amounts of a\nparticular Component beyond the foregoing limitation on Supplier's obligation to\nsupply, upon Purchaser's reasonable request, but consistent with Supplier's\nother business obligations.\n\n     3.5  Inventory.  The Supply Procedures shall also establish an inventory\nmechanism for Components, which shall provide that: (a) within an agreed period\nof time after the commercial launch of a particular Product, Supplier shall use\nReasonable Efforts to maintain an inventory of the Components in such Product at\nleast equal to the written forecast for purchases of such Product to be made\nduring an agreed number of months in the most recent forecast provided to\nSupplier by Purchaser under the forecasting mechanism of the Supply Procedures;\n(b) Purchaser shall maintain an inventory of all Components in accordance with\nPurchaser's normal practices, and shall give Supplier quarterly updates of the\nextent of such inventory; (c) Supplier's inventory of Components maintained\nunder such inventory mechanism shall only be permitted to fall below the levels\nestablished in subsection (a) above in the event that Purchaser submits orders\nin excess of the forecasted amounts or Supplier experiences manufacturing or\nsupply problems with respect to the Components; and (d) Supplier shall use\nReasonable Efforts in accordance with Supplier's normal practices to promptly\nreplenish any inventory of Components that is depleted in satisfying purchases\nof such Component by Purchaser hereunder.\n\n     3.6  Amendments.  The Parties further agree that if the foregoing\nforecasting, ordering or inventory mechanisms established in the Supply\nProcedures are determined by the Parties, in good faith cooperation and giving\nreasonable consideration to each Party's economic and business needs, to be\ninappropriate given the experience of the Parties and the then-existing\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       10\n\n \nmanufacturing and supply circumstances regarding Components hereunder, the\nParties will discuss in good faith appropriate amendments to the applicable\nmechanisms in the Supply Procedures.\n\n     3.7  Resolution of Supply Problems.\n\n         (a)  If Supplier determines that Supplier will not be able to supply to\nPurchaser a material amount of the most recent orders and\/or binding forecasts\nof orders for a particular Component submitted by Purchaser in accordance with\nthe applicable Supply Procedures, Supplier shall immediately notify Purchaser in\nwriting of such determination, which notice shall provide Purchaser with the\ndetails on the extent of the expected shortfall of supply, the causes of such\ninability to supply, and Supplier's proposed solution to the problem. Upon such\nnotice of a supply problem, or in any event upon Supplier's failure to satisfy,\nwithin the delivery time frame specified by Purchaser consistent with the Supply\nProcedures, a portion of the Components ordered by Purchaser in compliance with\nthis Agreement, (provided that such supply problem or failure cannot be\nsatisfied or addressed by Purchaser's and Supplier's existing inventories for\nsuch Components and will cause an interruption in the supply of such Components\nby Purchaser or its Affiliates to the commercial market for more than thirty\n(30) days), Purchaser and Supplier will immediately meet and work together, in\ngood faith, to identify an appropriate resolution to the supply problem. The\nParties will discuss all appropriate means of resolving the problem, including\nwithout limitation establishing an alternative source of supply for the affected\nComponents, creating a back-up manufacturing facility, or permitting Purchaser\nto manufacture an agreed amount of Components to cover the shortfall in supply,\nwith Supplier continuing to supply an agreed amount of such Components. Any\nagreed resolution to the supply problem will be set forth in a writing executed\nby both Parties.\n\n         (b)  If the Parties cannot reach agreement on an appropriate resolution\nto the supply problem within ten (10) days of commencing such discussions under\nsubsection (a) above, senior management representatives of the Parties will\nimmediately meet to discuss in good faith the problem in an effort to reach\nagreement on such resolution. As part of such discussions, Supplier shall make a\nfirm commitment of the amount of the affected Components that Supplier will be\nable to supply, on a monthly basis, during the period when such supply problem\nwith respect to such Components is expected to continue. Any agreed resolution\nby the Parties to the supply problem will be set forth in a writing executed by\nboth Parties. If, despite good faith efforts, the senior management officials\nare unable to reach agreement on the resolution of such supply problem within\ntwenty (20) days of their commencing such discussions, then at either Party's\nimmediate written request, the problem will be governed by the terms of Section\n11.7 if it affects Components other than Kirin Antigen or Dendreon Antigen, and\nby the terms of Section 3.7(c) if it affects Kirin Antigen or Dendreon Antigen.\n\n         (c)  If there is a material supply problem with respect to Kirin\nAntigen or Dendreon Antigen subject to the provisions of subsections 3.7(a) and\n(b) above, and (i) the Parties have failed to reach agreement on the resolution\nof such problem within the time frames set forth above by the end of the twenty\n(20) day period as provided under subsection (b), or (ii) Supplier has failed to\nmeet to discuss the problems as required above, then at Purchaser's written\nrequest provided to Supplier no more than sixty (60) days after the foregoing\nconditions have been met, Supplier shall grant to Purchaser a co-exclusive\nlicense as to Kirin Antigen or Dendreon Antigen, as applicable, (the 'Back-Up\nLicense'), under the relevant Supplier Patents\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       11\n\n \nand Manufacturing Know-how, as necessary to permit Purchaser to make or have\nmade such Kirin Antigen or Dendreon Antigen that is the subject of such supply\nproblem that was not resolved by the Parties, solely for sale in accordance with\nthe terms of this Agreement, the Collaborative License Agreement and the\nResearch and License Agreement, and solely in quantities to meet the amounts of\nPurchaser's and its Affiliates' and sublicensees' (if any), and Supplier's and\nits Affiliates' and sublicensees' (if any), if applicable, requirements for such\nKirin Antigen or Dendreon Antigen above the amounts of such Kirin Antigen or\nDendreon Antigen that Supplier remains able and willing to supply on a timely\nbasis under this Article 3. Purchaser covenants, represents and warrants that\nPurchaser shall not exercise the Back-Up License unless and until the conditions\nspecified in the first sentence of this Section 3.7(c) have been completely\nsatisfied and shall not use or practice the licensed Supplier Patents and\nManufacturing Know-how for any purpose except as expressly permitted in the\nforegoing. Immediately upon Purchaser's written request hereunder to obtain the\nBack-Up License, Supplier shall transfer to Purchaser copies of all information,\nincluding technical information, that is Controlled by Supplier, relates to the\nmanufacture of the Kirin Antigen or Dendreon Antigen that is the subject of the\nBack-Up License and is reasonably necessary to enable Purchaser to manufacture\nsuch Kirin Antigen or Dendreon Antigen. Thereafter, but only during the period\nwhen Purchaser is permitted hereunder to exercise the Back-Up License, Purchaser\nshall be permitted access to and a right of reference to any Regulatory\nApprovals held in Supplier's name for the Kirin Antigen or Dendreon Antigen that\nis the subject of such Back-Up License. Supplier shall provide Purchaser\nreasonable assistance, at Purchaser's request and Purchaser's expense, with\nrespect to understanding such manufacturing information and practicing the Back-\nUp License.\n\n                 (i)  At such time as Supplier is reasonably able to meet all of\nPurchaser's forecasted orders for Kirin Antigen or Dendreon Antigen, as\napplicable, the Back-Up License granted under this Section 3.7(c) shall\nterminate with respect to such Kirin Antigen or Dendreon Antigen, and Purchaser\nshall immediately cease to exercise and practice the Back-Up License, provided\nthat Purchaser shall retain all rights under this Section 3.7 with respect to\nany subsequent supply problem as to any Kirin Antigen or Dendreon Antigen, as\napplicable.\n\n                 (ii) Purchaser will pay Supplier a royalty of [ * ] of the Net\nRevenue of Kirin Products or Dendreon Products (as applicable) manufactured by\nor on behalf of Purchaser pursuant to exercise of the Back-Up License and sold\nby Purchaser or its Affiliate or sublicensee. Nothing in the foregoing shall\nlimit or affect in any way Purchaser's obligations to make the payments set\nforth in this Agreement to the full extent required on all Components supplied\nto Purchaser by Supplier.\n\n     3.8  Acceptance and Rejection. Purchaser shall have the right to test at\nits expense, using testing procedures agreed upon by the Parties and set forth\nin the specifications for the applicable Component, a portion of each shipment\nof Components to confirm that such shipment meets the applicable specifications.\nWhere it is required by local regulations, further testing on importation in\naccordance with the applicable specifications shall be carried out by Purchaser.\nIf Purchaser rejects in whole or in part any nonconforming shipment of\nComponents, Purchaser shall immediately provide Supplier written notice of such\nrejection. If Supplier agrees with Purchaser's determination that a shipment of\nComponents does not comply with applicable specifications, Supplier shall use\nReasonable\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       12\n\n \nEfforts to replace the nonconforming Components, at no additional cost to\nPurchaser. If Supplier reasonably disputes Purchaser's conclusion that such\nComponents do not meet the applicable specifications, Supplier shall use\nReasonable Efforts to replace such shipment of Components to Purchaser, at\nPurchaser's expense. If Supplier disagrees with Purchaser's determination that\nthe rejected shipment did not meet the applicable specifications, a sample of\nthe rejected shipment shall be submitted to an independent, qualified Third\nParty laboratory that is mutually acceptable and selected by the Parties\npromptly in good faith. Such laboratory shall determine whether the rejected\nComponents (as applicable) meet the applicable specifications, and such\nlaboratory's determination shall be final and determinative for purposes of this\nAgreement. The Party against whom the laboratory rules shall bear all costs of\nthe laboratory testing. If the laboratory rules that the shipment of Components\nfailed to meet the applicable specifications, at Purchaser's choice, the price\npaid by Purchaser for such nonconforming shipment shall be reimbursed to\nPurchaser (provided Purchaser paid for such shipment) or Components meeting the\napplicable specifications shall be shipped to Purchaser by Supplier. If the\nlaboratory rules the rejected shipment of Components met the applicable\nspecifications, then Purchaser shall accept such shipment (including all costs\nof shipping and insurance). Shipments of Components not meeting the applicable\nspecifications may, at Supplier's option and expense, be returned to Supplier or\ndestroyed by Purchaser. If Supplier has acknowledged in writing that it is\nunable to produce conforming Components, any sums actually paid therefor will be\nrefunded with interest, and the supply problem will be resolved in accordance\nwith Section 3.7. The remedy of replacement or refund is available only if such\nnonconformance was not caused by Purchaser's misuse, unauthorized modifications,\nneglect, improper testing or improper storage, including without limitation\nstorage at inappropriate temperatures, of such shipment of Components.\n\n     3.9  Kirin Manufacture of Dendreon Components. Kirin agrees to provide\nDendreon, its Affiliates and Sublicensees with their commercial requirements of\nKirin Components necessary for Licensed Kirin Products for which Regulatory\nApproval has been obtained, pursuant to the terms of this Article 3. In\naddition, if so requested by Dendreon, Kirin may negotiate with Dendreon for the\nmanufacture and supply by Kirin to Dendreon of certain Separation Devices,\nReagents and\/or Dendreon Antigens at a transfer price in an amount in U.S.\ndollars equal to Kirin's Fully-Burdened Manufacturing Costs for such Separation\nDevices, Reagents and\/or Dendreon Antigens plus a handling fee of [ * ], with\nany manufacture and supply to be governed by the terms of this Agreement and any\nadditional terms negotiated by the Parties. The Parties also agree to amend the\nterms of the Agreement to reflect such agreed terms for the manufacture and\nsupply by Kirin of Separation Devices, Reagents and\/or Dendreon Antigens, if\nany.\n\n                                   ARTICLE 4\n\n                            REGULATORY REQUIREMENTS\n\n     4.1  Manufacturing Facilities, Equipment and Licenses.  Supplier shall, at\nSupplier's expense, acquire or cause to be acquired all equipment and licenses,\nincluding, without limitation, all necessary plant equipment and facilities\nlicenses, necessary to enable the manufacture and testing of the Components as\nrequired hereunder.  Supplier shall obtain and maintain all necessary Regulatory\nApprovals.  Purchaser, its Affiliates and Sublicensees shall obtain any required\nimportation licenses or approvals for importation of Dendreon Products and Kirin\nProducts, and the Components necessary for such Kirin Products and Dendreon\nProducts, as applicable for sale in any given country.  Supplier shall cooperate\nreasonably with Purchaser, at Purchaser's reasonable request and expense, to\nobtain such licenses or approvals.\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       13\n\n \n      4.2  Manufacturing Regulatory Matters.\n\n           (a)  Supplier will be responsible for any reporting of matters\nregarding the manufacture of Components, as applicable, to the FDA and other\nrelevant regulatory authorities, in accordance with pertinent laws and\nregulations. Supplier shall notify Purchaser of any such matter if significant\nor serious and promptly furnish complete copies of such reports to Purchaser in\nthe English language. Supplier also shall advise Purchaser of any occurrence or\ninformation which arises out of Supplier's manufacturing activities which has\nadverse regulatory compliance and\/or reporting consequences concerning a\nComponent.\n\n           (b)  Supplier shall be responsible for handling and responding to any\nappropriate governmental agency inspections with respect to manufacturing of\nComponents during the term of this Agreement. Supplier shall provide to\nPurchaser any information requested by any governmental agency in connection\nwith any governmental inspection related to Components. Supplier shall use\nreasonable efforts to promptly advise Purchaser of any requests by any\ngovernmental agency for such inspections with respect to manufacturing of\nComponents.\n\n           (c)  Any changes by Supplier to the manufacturing process for\nComponents that may require approval by the FDA or other authorities or\namendment of existing Regulatory Approvals shall require the prior written\napproval of Purchaser, not to be unreasonably withheld or delayed.\n\n           (d)  Supplier certifies it did not and will not use in any capacity\nthe services of any person, including any firm or individual, debarred or\nsubject to debarment under the Generic Drug Enforcement Act of 1992, amending\nthe Food Drug and Cosmetic Act at 21 USC 335a. Supplier agrees to notify\nPurchaser immediately in the event any person providing services to Supplier\nunder the scope of the work of this Agreement is debarred or becomes subject to\ndebarment.\n\n           (e)  For the limited purpose of permitting a quality and compliance\naudit, Supplier shall grant to authorized representatives of Purchaser upon\nreasonable notice and not more than once per year, unless a substantial and\nreasonable need for an additional audit can be shown, access to areas of\nSupplier's plants and each of Supplier's Third Party supply contractor's plants,\nand to those technical records made by Supplier that only relate solely to\nQuality Assurance testing and regulatory compliance monitoring for manufacturing\nof Components, at such times as Components are being manufactured, solely for\nthe purpose of Purchaser determining that such manufacture is in compliance with\nregulatory requirements. Purchaser shall provide Supplier at least thirty (30)\nBusiness Days notice in writing of its desire to have such access. Supplier\nshall promptly respond to Purchaser's request and the Parties shall agree on the\ntime of and procedures for the audit. All such inspections shall be subject to\nconfidentiality obligations.\n\n     4.3   Product Recall Procedures.  The Parties shall immediately inform each\nother in writing of all Information relating to:  (a) any incident relating to a\nProduct and\/or any Product or Component that is the subject of recall, market\nwithdrawal or correction; or (b) any Components that may require, whether based\non manufacturing defect, tampering, or otherwise, a recall, field alert, product\nwithdrawal or field correction arising from any defect in any such Component\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       14\n\n \nprovided under this Agreement.  The Parties then shall meet and discuss the\nsituation in good faith to determine if a recall, field alert, product\nwithdrawal, or field correction is necessary.  In the event that either\nPurchaser or Supplier decides that a recall, field alert, product withdrawal, or\nfield correction is necessary due to any defect or other problem in any\nComponent, the Parties shall cooperate and use Reasonable Efforts in effecting\nany such required recall, market withdrawal or correction.  Payment of costs and\nexpenses associated with recalls, market withdrawals, market corrections and the\ncosts associated with replacement of the recalled or withdrawn Products or\nComponents shall be borne by the Party whose negligent or defective\nmanufacturing, processing, testing, packing or storage necessitated such recall,\nmarket withdrawal or market correction.\n\n     4.4  Documentation.  Supplier shall keep complete, accurate and authentic\naccounts, notes, data and records of the work performed under this Agreement.\nEach Party shall maintain complete and adequate records pertaining to the\nmethods and facilities used by it for the manufacture, processing, testing,\npacking, labeling, holding and distribution of Components in accordance with the\napplicable regulations in the United States and other countries so that the\nComponents may be used in Dendreon Products and Kirin Products to be used in\nhuman therapies.\n\n                                   ARTICLE 5\n\n                             FINANCIAL OBLIGATIONS\n\n     5.1  Purchase Prices.\n\n          (a)  Per Kirin's purchase of particular Dendreon Components hereunder,\nKirin shall pay Dendreon for the purchase of such Dendreon Components a transfer\nprice in an amount in U.S. Dollars equal to Dendreon's Fully-Burdened\nManufacturing Costs of such Dendreon Components plus a handling fee of [ * ];\nprovided, however, that for Dendreon Components that are purchased by Kirin for\nuse in a Dendreon Product for which the costs of manufacturing development\n(including process development) was supported by Kirin pursuant to Section 5.3,\nKirin shall pay Dendreon a transfer price in an amount in U.S. Dollars equal to\nDendreon's Fully-Burdened Manufacturing Costs of such Dendreon Components for\nsuch Dendreon Product plus a handling fee of [ * ]. Kirin shall pay Dendreon [ *\n] of the transfer price for a particular order of Dendreon Components within\nthirty (30) days of placing its order for such Dendreon Components, and [ * ] of\nsuch transfer price within thirty (30) days of delivery of such Dendreon\nComponents, pursuant to Section 2.4.\n\n          (b)  Per Dendreon's purchase of particular Kirin Components, Dendreon\nshall pay Kirin for the purchase of such Kirin Components a transfer price in an\namount in U.S. Dollars equal to Kirin's Fully-Burdened Manufacturing Costs of\nsuch Kirin Components plus a handling fee of [ * ]. Dendreon shall pay Kirin [ *\n] of the transfer price for a particular order of Kirin Components within thirty\n(30) days of placing its order for such Kirin Components, and [ * ] of such\ntransfer price within thirty (30) days of delivery of such Kirin Components,\npursuant to Section 2.4.\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       15\n\n \n     5.2  Audit.\n\n          (a)  Upon the written request of a Party (the 'Auditing Party'), and\nnot more than once in each calendar year, the other Party (the 'Audited Party')\nshall permit an independent certified public accounting firm of nationally\nrecognized standing selected by the Auditing Party, and reasonably acceptable to\nthe Audited Party, at the Auditing Party's expense, to have access during normal\nbusiness hours, and upon reasonable prior written notice, to such of the records\nof the Audited Party as may be reasonably necessary to verify the accuracy of\nthe reports of the Audited Party's Fully-Burdened Manufacturing Costs for\nComponents hereunder for any calendar year ending not more than thirty-six (36)\nmonths prior to the date of such request. The accounting firm shall disclose to\nthe Auditing Party and the Audited Party only whether such reports are correct\nor incorrect and the specific details concerning any discrepancies. No other\ninformation shall be provided to the Auditing Party.\n\n          (b)  If such accounting firm concludes that the Audited Party\noverstated its Fully-Burdened Manufacturing Costs for a particular Component or\nComponents during such period, the Audited Party shall reimburse the Auditing\nParty the difference between what the Auditing Party paid and what was actually\nowed, with interest from the date originally due at the prime rate, as published\nin The Wall Street Journal (Eastern U.S. Edition) on the last business day\npreceding such date, within thirty (30) days after the date the Auditing Party\ndelivers to the Audited Party such accounting firm's written report. If the\namount of the difference is greater than five percent (5%) of the total amount\nowed, then the Audited Party shall in addition reimburse the Auditing Party for\nall costs related to such audit.\n\n          (c)  The Auditing Party shall treat all information subject to review\nunder this Section 5.2 in accordance with the confidentiality provisions of\nArticle 6 of this Agreement, and shall cause its accounting firm to enter into\nan acceptable confidentiality agreement with the Audited Party obligating such\nfirm to retain all such financial information in confidence pursuant to such\nconfidentiality agreement.\n\n          (d)  If the Audited Party in good faith disputes the conclusion of the\naccounting firm under subsection (b) above that the Audited Party overstated its\nFully-Burdened Manufacturing Costs for a particular Component or Components, or\nany specific aspect of the conclusion, then the Audited Party shall inform the\nAuditing Party by written notice within thirty (30) days of receiving a copy of\nthe audit containing such conclusion, specifying in detail the reasons for the\nAudited Party's disputing such conclusion. The Parties shall promptly thereafter\nmeet and negotiate in good faith a resolution to such dispute. In the event that\nthe Parties are unable to resolve such dispute within sixty (60) days after such\nAudited Party notice, the matter shall be resolved in a manner consistent with\nthe procedures set forth in Section 11.7.\n\n     5.3  Financing the Development of Dendreon Products.    As set forth below,\nKirin shall have the option, but not the obligation, to provide financial\nsupport for the development of Dendreon Products which Dendreon desires Kirin to\nfinancially support and which are to be supplied to Kirin hereunder.  To\nexercise its option to support those certain Dendreon Products, Kirin shall\nnotify Dendreon in writing, within thirty (30) days of Kirin's receipt of\nwritten notice from Dendreon that Dendreon is developing such a Dendreon\nProduct, that Kirin agrees to pay Dendreon for all of its scale-up and other\ndevelopment costs related to the development of the Dendreon Components for such\nDendreon Product up to a total of [ * ] for such Dendreon\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       16\n\n \nProduct. All payments due to Dendreon pursuant to this Section 5.3 shall be made\nby Kirin within thirty (30) days of receipt of Dendreon's invoice therefor. The\nforegoing option shall be exercised, if at all, on a product-by-product basis as\nto each Dendreon Product for which Dendreon provides Kirin the applicable\nnotice.\n\n                                   ARTICLE 6\n\n                                CONFIDENTIALITY\n\n     6.1  Confidentiality; Exceptions.  Except to the extent expressly\nauthorized by this Agreement or otherwise agreed in writing, the Parties agree\nthat, for the term of this Agreement and for ten (10) years thereafter, the\nreceiving Party shall keep confidential and shall not publish or otherwise\ndisclose to a Third Party or use for any purpose other than as provided for in\nthis Agreement any Information and materials furnished to it by the other Party\npursuant to this Agreement (collectively, 'Confidential Information'), except to\nthe extent that it can be established by the receiving Party by competent proof\nthat such Confidential Information:\n\n          (a)  was already known to the receiving Party, other than under an\nobligation of confidentiality, at the time of disclosure by the other Party;\n\n          (b)  was generally available to the public or otherwise part of the\npublic domain at the time of its disclosure to the receiving Party;\n\n          (c)  became generally available to the public or otherwise part of the\npublic domain after its disclosure and other than through any act or omission of\nthe receiving Party in breach of this Agreement; or\n\n          (d)  was disclosed to the receiving Party, other than under an\nobligation of confidentiality, by a Third Party who had no obligation to the\ndisclosing Party not to disclose such information to others.\n\n     6.2  Authorized Disclosure.  Each Party may disclose the other's\nConfidential Information to the extent such disclosure is reasonably necessary\nin filing or prosecuting patent applications, prosecuting or defending\nlitigation, complying with applicable governmental regulations or conducting \npre-clinical or clinical trials, provided that if a Party is required by law or\nregulation to make any such disclosure of the other Party's Confidential\nInformation it will except where impracticable for necessary disclosures, for\nexample in the event of medical emergency, give reasonable advance notice to the\nother Party of such disclosure requirement and, except to the extent\ninappropriate in the case of patent applications, will use its best efforts to\nsecure confidential treatment of such Confidential Information required to be\ndisclosed.\n\n     6.3  Survival.  This Article 6 shall survive the termination or expiration\nof this Agreement for a period of ten (10) years.\n\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       17\n\n \n                                   ARTICLE 7\n\n                             INTELLECTUAL PROPERTY\n\n     Unless specifically and expressly granted herein, no licenses or rights\nunder either Party's intellectual property rights are implied or granted in this\nAgreement.  Each Party shall retain full ownership of all its inventions and\nintellectual property.  The prosecution of any patents, patent applications and\nany and all other intellectual property rights associated with the manufacture\nand supply of Components shall be governed by the terms of the Collaborative\nLicense Agreement.\n\n                                   ARTICLE 8\n\n                         REPRESENTATIONS AND WARRANTIES\n\n     8.1  General.  Each of the Parties hereby represents and warrants: (a) the\nAgreement is a legal and valid obligation binding upon such Party and\nenforceable in accordance with its terms; (b) the execution, delivery and\nperformance of the Agreement by such Party does not conflict with any agreement,\ninstrument or understanding, oral or written, to which it is a Party or by which\nit is bound; and (c) the Agreement does not violate any law or regulation of any\ncourt, governmental body or administrative or other agency having jurisdiction\nover it.\n\n     8.2  Component Warranty.\n\n          (a)  Dendreon warrants to Kirin, for a period of twelve (12) months\nfrom delivery for Separation Devices and Reagent, a period of nine (9) months\nfrom delivery for recombinant antigen PA 2024 and a period of six (6) months\nfrom delivery for Dendreon Antigen other than recombinant antigen PA 2024, that\nthe Separation Devices, Reagent and Dendreon Antigen, as applicable, supplied by\nDendreon to Kirin shall: (i) be manufactured in accordance with current Good\nManufacturing Practices (for medical devices and drugs as promulgated and\namended by the FDA); and (ii) conform with applicable Dendreon specifications at\nthe time of delivery by Dendreon. The preceding warranty specifically excludes,\nand Dendreon shall not be liable for, any action or omission by Kirin or any\nother entity, specifically including any failure to store or transport Dendreon\nComponents (after Dendreon's delivery pursuant to Section 2.4(a)) in accordance\nwith applicable specifications, which results in the damage or destruction of\nDendreon Components after Dendreon has delivered the Dendreon Components to\nKirin pursuant to Section 2.4. Kirin's sole remedy for breach of the foregoing\nwarranty as to a particular Dendreon Component shall be repair, replacement or\nrefund of the purchase price paid by Kirin, at Dendreon's sole option.\n\n          (b)  Kirin warrants to Dendreon, for a period of twelve (12) months\nfrom delivery, pursuant to Section 2.4, for any Kirin Components other than\nKirin Antigen, and a period of six (6) months from delivery for Kirin Antigen,\nthat the Kirin Components supplied by Kirin to Dendreon shall: (i) be\nmanufactured in accordance with current Good Manufacturing Practices (for\nmedical devices and drugs as promulgated and amended by the FDA); and (ii)\nconform with applicable Kirin specifications at the time of delivery by Kirin.\nThe preceding warranty specifically excludes, and Kirin shall not be liable for,\nany action or omission by Dendreon or any other entity, specifically including\nany failure to store or transport Kirin\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       18\n\n \nComponents (after Kirin's delivery purusnat to Section 2.4(b)) in accordance\nwith applicable specifications, which results in the damage or destruction of\nKirin Components after Kirin has delivered the Kirin Components to Dendreon\npursuant to Section 2.4. Dendreon's sole remedy for breach of the foregoing\nwarranty as to a particular Kirin Component shall be repair, replacement or\nrefund of the purchase price paid by Dendreon, at Kirin's sole option.\n\n     8.3  Warranty Disclaimer.  THE EXPRESS WARRANTIES IN THIS ARTICLE 8 ARE IN\nLIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION,\nTHE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND\nNONINFRINGEMENT.\n\n                                   ARTICLE 9\n\n                              TERM AND TERMINATION\n\n     9.1  Term.  This Agreement shall commence on the Effective Date and, unless\nsooner terminated as provided herein, shall continue in effect until the\nexpiration or termination of the Collaborative License Agreement, unless\nextended upon the mutual, written agreement of the Parties.\n\n     9.2  Termination.\n\n          (a)  If either Party materially breaches this Agreement at any time,\nwhich breach is not cured within thirty (30) days of written notice thereof if\nsuch breach is caused by the failure of a Party to meet its financial\nobligations under this Agreement, or within ninety (90) days of written notice\nthereof for any other material breach of this Agreement, from the non-breaching\nParty specifying in detail the nature of the breach, the non-breaching Party\nshall have the right to terminate the Agreement.\n\n          (b)  Either Party may terminate this Agreement, effective immediately\nupon the giving of written notice, if the other Party shall file a petition for\nbankruptcy, or shall be adjudicated a bankrupt or insolvent, or shall take\nadvantage of the insolvency laws of any state of the United States or of any\ncountry, or shall make an assignment for the benefit of creditors, or shall have\na receiver appointed, whether by private instrument or by court officer, for its\nproperty which is not dismissed within sixty (60) days, or become subject to an\ninvoluntary petition for bankruptcy which in not dismissed within sixty (60)\ndays.\n\n\n     9.3  Surviving Obligations.  Termination or expiration of this Agreement\nshall not (a) affect any other rights of either Party which may have accrued up\nto the date of such termination or expiration, or (b) relieve Purchaser of its\nobligation to pay to Supplier sums due in respect of Components delivered and\naccepted prior to termination or expiration of this Agreement. The provisions of\nArticles 6, 7 and 10, and Sections 4.4, 5.2 and 11.6 of this Agreement shall\nsurvive termination or expiration of this Agreement.\n\n     9.4  Termination Without Cause.  This Agreement may be terminated at any\ntime upon mutual, written agreement of the Parties.\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       19\n\n \n                                  ARTICLE 10\n\n                                INDEMNIFICATION\n\n     10.1  Indemnification by Dendreon.\n\n           (a)  Subject to compliance with Section 10.3, Dendreon agrees to\nindemnify, defend and hold harmless Kirin, its Affiliates, and their respective\nofficers, directors, shareholders, representatives, agents and employees (the\n'Kirin Indemnitees'), from and against any and all losses, liabilities, damages,\ncosts, fees and expenses, including reasonable legal costs and attorneys' fees\n('Losses') resulting from a Third Party claim, suit or action based upon: (i)\ndeath or injury to any person or damage to any property to the extent caused by\nthe defective or negligent manufacture of a Component or Product manufactured by\nor on behalf of Dendreon and sold to Kirin and its Affiliates hereunder (the\n'Defective Manufacturing Claim'); (ii) death or injury to any person or damage\nto any property to the extent caused by the defective or negligent marketing or\npromotion of a Product by Dendreon or its Affiliates hereunder (a 'Defective\nMarketing Claim'); (iii) harm or damage attributable to or caused by the acts or\nomissions of Dendreon or its Affiliates or their respective officers, directors,\nrepresentatives, agents or employees; or (iv) breach of any representation or\nwarranty of Dendreon set forth in Article 8.\n\n           (b)  Dendreon shall have no obligation under this Section 10.1 with\nrespect to any Losses resulting from: (i) the negligent or intentionally\nwrongful act or omission of Kirin, its Affiliates or their respective officers,\ndirectors, representatives, agents or employees; (ii) the improper storage,\ntransportation, marketing, training, or handling of a Component or Product by\nany person or entity other than Dendreon, its Affiliates or their respective\nofficers, directors, representatives, agents or employees; (iii) the improper\nuse of a Component or Product by any person or entity other than Dendreon, its\nAffiliates or their respective officers, directors, agents or employees; or (iv)\nany claims based upon death or injury to any person or damage to any property\ncaused by a Component or Product that is attributable to or caused by acts or\nomissions of Kirin or its sublicensees or their respective Affiliates or their\nrespective officers, directors, representatives, agents or employees. With\nrespect to any Third Party claim, suit or action based upon death or injury to\nany person or damage to any property based on use of a Product, Dendreon agrees\nto provide Kirin, at Kirin's expense, with reasonable assistance in Kirin's\ndefense of such claim, suit or action.\n\n     10.2  Indemnification by Kirin.\n\n           (a)  Subject to compliance with Section 10.3, Kirin agrees to\nindemnify and defend Dendreon, its Affiliates, and their respective officers,\ndirectors, shareholders, representatives, agents and employees (the 'Dendreon\nIndemnitees'), from and against any and all Losses (as defined in Section 10.1)\nresulting from a Third Party claim, suit or action based upon: (i) a Defective\nManufacturing Claim (as defined in Section 10.1); (ii) a Defective Marketing\nClaim (as defined in Section 10.1); (iii) harm or damage attributable to or\ncaused by the acts or omissions of Kirin or its Affiliates or their respective\nofficers, directors, representatives, agents or employees; or (iv) breach of any\nrepresentation or warranty of Kirin in Article 8.\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       20\n\n \n           (b)  Kirin shall have no obligation under this Section 10.2 with\nrespect to any Losses resulting from: (i) the negligent or intentionally\nwrongful act or omission of Dendreon, its Affiliates or their respective\nofficers, directors, representatives, agents or employees; (ii) the improper\nstorage, transportation, marketing, training, or handling of a Component or\nProduct by entities or persons other than Kirin or its sublicensees or their\nrespective Affiliates, or their respective officers, directors, representatives,\nagents or employees; (iii) the improper use of a Product or Component, unless\ncaused by Kirin or its sublicensees or their respective Affiliates, or their\nrespective officers, directors, representatives, agents or employees; or (iv)\nany claims based upon death or injury to any person or damage to any property\ncaused by a Component or Product that is attributable to or caused by acts or\nomissions of Dendreon or its sublicensees or their respective Affiliates or\ntheir respective officers, directors, representatives, agents or employees. With\nrespect to any Third Party claim, suit or action based upon death or injury to\nany person or damage to any property based on use of a Product, Kirin agrees to\nprovide Dendreon, at Dendreon's expense, with reasonable assistance in\nDendreon's defense of such claim, suit or action.\n\n     10.3  Indemnity Procedure.   In the event that a Party is seeking\nindemnification under Section 10.1 or 10.2, it shall inform the other Party (the\n'Indemnifying Party') of a claim as soon as reasonably practicable after it\nreceives notice of the claim, shall permit the Indemnifying Party to assume\ndirection and control of the defense of the claim (including the right to settle\nthe claim solely for monetary consideration), and, at the Indemnifying Party's\nexpense, shall cooperate as reasonably requested in the defense of the claim.\nThe Indemnified Party shall have the right to retain its own counsel, subject to\nthe approval of any such outside counsel by the Indemnifying Party, with the\nfees and expenses to be paid by the Indemnifying Party if representation of such\nParty by the counsel retained by Indemnifying Party would be inappropriate due\nto actual or potential differing interests between such indemnitee and any other\nParty represented by such counsel in such proceedings.  The Indemnifying Party\nmay not settle such action or claim, or otherwise consent to an adverse judgment\nin such action or claim, without the express written consent of the Indemnified\nParty if such settlement or adverse judgment diminishes the rights or interests\nof the Indemnified Party.\n\n                                  ARTICLE 11\n\n                                 MISCELLANEOUS\n\n\n     11.1  Assignment.  Neither Party shall assign any of its rights and\nobligations hereunder except (i) as incident to the merger, consolidation,\nreorganization or acquisition of stock affecting actual voting control or of\nsubstantially all of the assets of the assigning Party; or (ii) to an Affiliate;\nprovided, however, that in no event shall either Party's rights and obligations\nhereunder be assigned without prior written notice to the other Party.  In any\ncase, neither Party may make an assignment of its assets which renders it unable\nto perform its material obligations hereunder.  This Agreement shall be binding\nupon and inure to the benefit of the Parties hereto and their permitted\nsuccessors and assigns.\n\n     11.2  Retained Rights.  Nothing in this Agreement shall limit in any\nrespect the right of either Party to conduct research and development with\nrespect to, and market products outside of, the Field using such Party's\nTechnology, but no license to use the other Party's technology to do so is\ngranted herein expressly or by implication.\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       21\n\n \n     11.3  Force Majeure.  Neither Party shall lose any rights hereunder or be\nliable to the other Party for damages or losses on account of failure of\nperformance by the defaulting Party if the failure is occasioned by government\naction, war, fire, explosion, flood, strike, lockout, embargo, act of God, or\nany other similar cause beyond the control of the defaulting Party, provided\nthat the Party claiming force majeure has exerted all reasonable efforts to\navoid or remedy such force majeure; provided, however, in no event shall a Party\nbe required to settle any labor dispute or disturbance.\n\n     11.4  Further Actions.  Each Party agrees to execute, acknowledge and\ndeliver such further instruments, and to do all such other acts, as may be\nnecessary or appropriate in order to carry out the purposes and intent of this\nAgreement.\n\n     11.5  No Trademark Rights.  Except as otherwise provided in the\nCollaborative License Agreement, no right, express or implied, is granted by the\nAgreement to use in any manner the name 'Dendreon' or 'Kirin' or any other trade\nname or trademark of the other Party in connection with the performance of the\nAgreement.\n\n     11.6  Notices.  All notices and other communications hereunder shall be in\nwriting and shall be deemed given if delivered personally or by facsimile\ntransmission (receipt verified), telexed, mailed by registered or certified mail\n(return receipt requested), postage prepaid, or sent by express courier service,\nto the Parties at the following addresses (or at such other address for a Party\nas shall be specified by like notice; provided, that notices of a change of\naddress shall be effective only upon receipt thereof):\n\n           If to Dendreon, addressed to:\n\n           Dendreon Corporation\n           3005 1st Avenue\n           Seattle, WA  98121-1010\n           Attention: C. S. Henney\n           Telephone:(206) 256-4545\n           Telecopy:  (206) 256-0571\n\n           With copy to:\n\n           Cooley Godward llp\n           Five Palo Alto Square, 4th Floor\n           Palo Alto, CA  94306\n           Attention:  Barclay James Kamb, Esq.\n           Telephone:  (650) 843-5052\n           Telecopy:    (650) 857-0663\n\n           If to Kirin, addressed to:\n\n           Kirin Brewery Co., Ltd.\n           26-1, Jingumae 6-chome\n           Shibuya-ku\n           Tokyo 150-8011, Japan\n\n\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       22\n\n \n           Attention:  Akihiro Shimosaka\n                       Research and Product Development Department\n           Telephone:  (03) 5485-6805\n           Telecopy:   (03) 3499-6152\n\n     11.7  Dispute Resolution.  If any dispute, controversy or claim arises out\nof or in connection with this Agreement, the Parties shall use reasonable\nefforts to settle it by friendly negotiation within sixty (60) days of notice\nfrom one Party to the other of such dispute, controversy or claim, before\npursuing any other remedies available to them. If either Party fails or refuses\nto participate in such negotiations, or if, in any event, the dispute,\ncontroversy or claim is not resolved to the satisfaction of both Parties within\nthe sixty (60) day period, any such dispute, controversy or claim shall be\nsettled by arbitration. Any such arbitration shall be conducted in accordance\nwith the Japan-American Trade Arbitration Agreement of September 16, 1952. The\nParties agree that any such arbitration shall be conducted in the English\nlanguage in a location within the United States selected by the Party that did\nnot initiate such arbitration, and the Agreement shall be governed by and\nconstrued in accordance with the laws of the State of California and the United\nStates of America. The arbitrators shall include one independent, un-affiliated\nnominee selected by each Party and a third neutral arbitrator selected by such\nnominees. The Parties agree that any arbitration panel shall include members\nknowledgeable as to the evaluation of biopharmaceutical technology. Judgment\nupon the award rendered may be entered in the highest state or federal court or\nforum, state or federal, having jurisdiction; provided, however, that the\nprovisions of this Section 11.7 shall not apply to any dispute or controversy as\nto which any treaty or law prohibits such arbitration. The prevailing Party\nshall be entitled to reasonable attorney's fees and costs to be fixed by the\narbitrators.\n\n     11.8  Waiver.  Except as specifically provided for herein, the waiver from\ntime to time by either of the Parties of any of their rights or their failure to\nexercise any remedy shall not operate or be construed as a continuing waiver of\nsame or of any other of such Party's rights or remedies provided in this\nAgreement.\n\n     11.9  Severability.  If any term, covenant or condition of this Agreement\nor the application thereof to any Party or circumstance shall, to any extent, be\nheld to be invalid or unenforceable, then the remainder of this Agreement, or\nthe application of such term, covenant or condition to Parties or circumstances\nother than those as to which it is held invalid or unenforceable, shall not be\naffected thereby and each term, covenant or condition of this Agreement shall be\nvalid and be enforced to the fullest extent permitted by law.\n\n     11.10 Ambiguities.  Ambiguities, if any, in this Agreement shall not be\nconstrued against any Party, irrespective of which Party may be deemed to have\nauthored the ambiguous provision.\n\n     11.11 Entire Agreement.  This Agreement sets forth all the covenants,\npromises, agreements, warranties, representations, conditions and understandings\nbetween the Parties hereto with regard to the subject matter discussed herein\nand supersedes and terminates all prior agreements and understanding between the\nParties with regard to the subject matter discussed herein. There are no\ncovenants, promises, agreements, warranties, representations conditions or\nunderstandings, either oral or written, between the Parties with regard to the\nsubject matter discussed herein other than as set forth in this Agreement.\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       23\n\n \n     11.12  Headings.  The Section and Paragraph headings contained herein are\nfor the purposes of convenience only and are not intended to define or limit the\ncontents of the Section or Paragraphs to which they apply.\n\n     In Witness Whereof, the Parties have executed this Agreement in duplicate\noriginals by their proper officers as of the date and year first above written.\n\nDENDREON CORPORATION                  KIRIN BREWERY CO., LTD.\n\nBy: \/s\/ Christopher S. Henney         By: \/s\/ Koichiro Aramaki\n    -------------------------            -------------------------------------\n                                         Managing Director\nTitle: President &amp; CEO                Title: President of Pharmaceutical\n       ---------------                      ----------------------------\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n                                       24\n\n \n                                   EXHIBIT A\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY\nBRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE\nCOMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.\n\n\n<\/pre>\n","protected":false},"template":"","meta":{"_acf_changed":false,"_stopmodifiedupdate":true,"_modified_date":"","_cloudinary_featured_overwrite":false},"corporate_contracts_companies":[7299],"corporate_contracts_industries":[9407],"corporate_contracts_types":[9613,9619],"class_list":["post-42511","corporate_contracts","type-corporate_contracts","status-publish","hentry","corporate_contracts_companies-dendreon-corp","corporate_contracts_industries-drugs__pharma","corporate_contracts_types-operations","corporate_contracts_types-operations__sales"],"acf":[],"_links":{"self":[{"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts\/42511","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts"}],"about":[{"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/types\/corporate_contracts"}],"wp:attachment":[{"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/media?parent=42511"}],"wp:term":[{"taxonomy":"corporate_contracts_companies","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_companies?post=42511"},{"taxonomy":"corporate_contracts_industries","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_industries?post=42511"},{"taxonomy":"corporate_contracts_types","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_types?post=42511"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}