{"id":42237,"date":"2015-09-17T11:25:58","date_gmt":"2015-09-17T16:25:58","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-legal\/contracts\/uncategorized\/distribution-agreement-astra-merck-enterprises-inc-and-astra.html"},"modified":"2015-09-17T11:25:58","modified_gmt":"2015-09-17T16:25:58","slug":"distribution-agreement-astra-merck-enterprises-inc-and-astra","status":"publish","type":"corporate_contracts","link":"https:\/\/corporate.findlaw.com\/contracts\/operations\/distribution-agreement-astra-merck-enterprises-inc-and-astra.html","title":{"rendered":"Distribution Agreement &#8211; Astra Merck Enterprises Inc. and Astra Pharmaceuticals LP"},"content":{"rendered":"<pre>\n                             DISTRIBUTION AGREEMENT\n\n\n                            Dated as of July 1, 1998\n\n                                     between\n\n                          ASTRA MERCK ENTERPRISES INC.\n\n                                       and\n\n                           ASTRA PHARMACEUTICALS, L.P.\n\n\n\n\n\n\n\n\n\n\n================================================================================\n   2\n                                TABLE OF CONTENTS\n\n                                                                            Page\n\nA.     DEFINITIONS........................................................     2\n\nB.     DISTRIBUTORSHIP....................................................     8\n\n       1.    Appointment of the Partnership as Distributor................     8\n\n       2.    Fee..........................................................    10\n\nB-1.   OPERATIONAL MATTERS................................................    10\n\nC.     OPTION WITH RESPECT TO COMPOUNDS...................................    14\n\nD.     REVERSION AND TERMINATION OF RIGHTS WITH RESPECT TO \n       DISTRIBUTION COMPOUNDS.............................................    15\n\nE.     INDS AND NDAS......................................................    20\n\nF.     REAPPOINTMENT OF PARTNERSHIP AS DISTRIBUTOR........................    21\n\nG.     DEVELOPMENT COSTS..................................................    22\n\nH.     TRADEMARKS.........................................................    23\n\nI.     INFRINGEMENT.......................................................    23\n\nJ.     COMPLIANCE CERTIFICATE; AUDIT RIGHTS...............................    23\n\nK.     SUBDISTRIBUTION AND ASSIGNMENT.....................................    25\n\nL.     [OMITTED]..........................................................    26\n\nM.     TERM AND TERMINATION...............................................    26\n\nN.     CONFIDENTIALITY AND PERMITTED DISCLOSURE EXCEPTIONS................    26\n\nO.     INDEMNIFICATION; DISCLAIMER; LIMITATION ON DAMAGES.................    26\n\nP.     [OMITTED]..........................................................    29\n\nQ.     ARBITRATION........................................................    29\n\nR.     MISCELLANEOUS......................................................    30\n   3\n                             DISTRIBUTION AGREEMENT\n\n\n         This DISTRIBUTION AGREEMENT (\"Agreement\") is made as of July 1, 1998 by\nand between ASTRA MERCK ENTERPRISES INC., a corporation organized and existing\nunder the laws of the State of Delaware (\"KBI-E\"), and ASTRA PHARMACEUTICALS,\nL.P., a limited partnership organized and existing under the laws of the State\nof Delaware (the \"Partnership\").\n\n                                    RECITALS\n\n         WHEREAS, Astra AB, a company limited by shares organized and existing\nunder the laws of Sweden (\"KB\" or the \"Licensor\"), and Astra Merck Inc., a\ncorporation organized and existing under the laws of the State of Delaware\n(\"KBI\"), have entered into that certain Amended and Restated License and Option\nAgreement made as of July 12, 1982, and amended and restated as of the date\nhereof, as such agreement is amended, modified, supplemented or restated from\ntime to time (the \"Amended and Restated KBI License\"), pursuant to which KB has\nlicensed to KBI the right under certain Licensed Patents, Trademarks and\nTechnical Information to make, have made, use and sell certain Licensed\nCompounds in the Territory and has granted to KBI options to obtain licenses\nwith respect to certain Compounds;\n\n         WHEREAS, pursuant to the Trademark Rights Contribution Agreement (as\ndefined in the Master Restructuring Agreement) and the Selected Compounds\nContribution Agreement (as defined in the Master Restructuring Agreement),\nrespectively, KBI has assigned to KBI Sub all of its rights with respect to\nTrademarks (as defined in the Amended and Restated KBI License) and all of its\nrights with respect to the Selected Compounds (as defined in the Selected\nCompounds Contribution Agreement) and to the Selected Uses (as defined in the\nSelected Compounds Contribution Agreement) for Licensed Compounds other than, in\nthe case of Selected Uses, the right to exercise options with respect to\nCompounds and other than certain rights with respect to omeprazole and\nFelodipine, and KBI Sub has assigned such rights to the Partnership;\n\n         WHEREAS, pursuant to that certain Assignment and Assumption of Amended\nand Restated License and Option Agreement (the \"KBI-E Assignment\") dated as of\nthe date hereof by and between KBI-E and KBI, KBI has assigned to KBI-E all of\nKBI's rights and obligations under the Amended and Restated KBI License other\nthan rights with respect to Trademarks, Selected Compounds and the Selected Uses\nfor Licensed Compounds;\n\n         WHEREAS, pursuant to the KBI-E Asset Contribution Agreement (as defined\nin the Master Restructuring Agreement), KBI-E has assigned to KBI Sub and KBI\nSub has assigned to the Partnership all of its rights with respect to the\nOmeprazole-for-Horses License (as such term is defined in the KBI-E Asset\nContribution Agreement);\n\n         WHEREAS, KBI has assigned to KBI-E all of KBI's rights to and under the\nLicense Agreement dated as of November 1, 1994 among TR and KBI (the \"Lexxel\nLicense\");\n\n\n                                       \n   4\n         WHEREAS, KBI and KBI-E have previously granted to The Procter &amp; Gamble\nCo. certain rights with respect to omeprazole for sale in the OTC market\npursuant to the P&amp;G Agreements and have transferred and assigned to the\nPartnership their respective rights and obligations under such agreements;\n\n         WHEREAS, KBI-E and the Partnership desire that the Partnership be\nappointed as the sole and exclusive distributor of the Distribution Products in\nthe Territory (as such terms are defined below), other than Non-Exclusive Second\nLook Products (as defined below), as to which the Partnership's rights shall be\nnon-exclusive, pursuant and subject to the terms of this Agreement; and\n\n         WHEREAS, the parties desire to arrange for the supply of Distribution\nProducts (as such term is defined below) to the Partnership, and KBI-E has\ndesignated KBI as the exclusive supplier of Distribution Products to the\nPartnership in order to satisfy KBI-E's obligation set forth in this Agreement\nto supply or cause to be supplied Distribution Products to the Partnership;\n\n         NOW, THEREFORE, in consideration of the premises and the covenants and\nconditions herein contained, the parties hereby agree as follows:\n\n\nA.       DEFINITIONS\n\n         Without limiting any other terms defined herein, as used in this\nAgreement the following terms shall have the following respective meanings:\n\n         \"Active Development Program\" shall mean, with respect to any Compound,\n(i) the use of reasonable efforts in the investigation, evaluation or\ndevelopment of such Compound for purposes of obtaining Marketing Approval in the\nTerritory, (ii) the expenditure of $3 million or more (determined on the basis\nof expense accruals in accordance with GAAP) in each full Fiscal Year after\nPhase III Clinical Evaluation has begun on Phase III Clinical Evaluation for\nsuch Compound or (iii) the expenditure of $1 million or more (determined on the\nbasis of expense accruals in accordance with GAAP) in each full Fiscal Year on\nPhase I safety studies or Phase II Clinical Evaluation for such Compound\n(including any Phase I safety studies or Phase II Clinical Evaluation performed\nif, having commenced Phase III Clinical Evaluation, additional testing and\nstudies under Phase I or Phase II Clinical Evaluation are required or deemed\nnecessary or appropriate); provided, however, that the foregoing amounts are\nsubject to adjustment for inflation in the manner provided in Section 3.8 of the\nMaster Restructuring Agreement and shall include all amounts expended\n(internally or externally) by such party and its Affiliates worldwide with\nrespect to such Compound (including, without limitation, expenditures in respect\nof Combinations containing such Compound), as long as such development program\nis directed at least in part toward obtaining Marketing Approval in the\nTerritory; provided, further, that compliance with any applicable FDA regulatory\nwaiting period, filing or other regulatory requirements shall constitute\nconducting an Active Development Program; and provided, further, that the\namounts set forth in clauses (ii) and (iii) above shall be pro rated for partial\nyears.\n\n\n                                       2\n   5\n         \"Actively Marketing\" shall mean with respect to any Compound the use by\nthe Partnership of reasonable efforts in the Territory with respect to\npromotion, marketing and sale of products containing such Compound after the\nlaunch thereof and during the period of Market Exclusivity; provided, however,\nthat (i) reasonable efforts with respect to any Compound in a Therapeutic\nCategory shall be satisfied if such efforts are used with respect to the\ntotality of Covered Compounds (taken as a whole) in such Therapeutic Category\nand (ii) if the efforts employed by the Partnership for the totality of the\nCovered Compounds (taken as a whole) in a specific Therapeutic Category are\nreasonable in the aggregate, the requirement of reasonable efforts for each\nDistribution Compound in such Therapeutic Category will be deemed satisfied; and\nprovided, further, that:\n\n                  (i) the Partnership shall not be deemed to have failed to\n         Actively Market any Compound unless it has used efforts and applied\n         resources with respect to the promotion, marketing and sale of products\n         containing such Compound (and products containing any Competing\n         Compound) that taken as a whole, under the circumstances, are\n         materially less than the efforts and resources that would reasonably be\n         expected to be applied consistent with generally prevailing standards\n         and practices in the pharmaceutical industry in the Territory, taking\n         into account competition, the properties of the Compound, the approved\n         claim structure for the Compound, the sales and profit potential of\n         products containing such Compound (and Competing Compounds), and the\n         nature and extent of market exclusivity;\n\n                  (ii) the Partnership shall not be deemed to have failed to\n         Actively Market any Compound:\n\n                  (A) with respect to the first thirty-six months following the\n                  First Commercial Sale thereof if, on a cumulative basis during\n                  such thirty-six month period, the Partnership's expenditures\n                  for the marketing and promotion of products containing such\n                  Compound (including any costs incurred in preparation for\n                  launch and determined on the basis of expense accruals in\n                  accordance with GAAP), exceed the sum of (1) 50% of the\n                  Partnership's Net Sales of such products during the first\n                  12-month period following such First Commercial Sale or $10\n                  million, whichever is greater, (2) 40% of the Partnership's\n                  Net Sales of such products during the second 12-month period\n                  following such First Commercial Sale and (3) 30% of the\n                  Partnership's Net Sales of such products during the third\n                  12-month period following such First Commercial Sale; and\n\n                  (B) with respect to any 12-month period beginning on an\n                  anniversary of the date of such First Commercial Sale,\n                  commencing with the third such anniversary, if the\n                  Partnership's expenditures for the marketing and promotion of\n                  products containing such Compound (determined on the basis of\n                  expense accruals in accordance with GAAP), with respect to\n                  such 12-month period exceed (1) 20% of the Partnership's Net\n                  Sales of such products, in the case of the fourth 12-month\n                  period following such First Commercial Sale, (2) 10% of the\n                  Partnership's Net \n\n\n                                       3\n   6\n                  Sales of such products, in the case of the fifth 12-month\n                  period following such First Commercial Sale or (3) 5% of the\n                  Partnership's Net Sales of such products, in the case of any\n                  such 12-month period thereafter; and\n\n                  (iii) the Partnership shall not be deemed to have failed to\n         Actively Market any Distribution Product containing such Distribution\n         Compound if the Partnership (and its Affiliates) have discontinued\n         marketing Distribution Products containing such Distribution Compound\n         or a product containing a Competing Compound on a global basis due to\n         reasons of safety or efficacy so long as the Partnership continues to\n         conduct an Active Development Program with respect to such Distribution\n         Compound or a Competing Compound.\n\n         \"Adverse Drug Experience\" shall mean \"adverse drug experience\" as used\nin applicable regulations promulgated from time to time by the FDA.\n\n         \"Agreement\" shall have the meaning set forth in the Preamble.\n\n         \"Amended and Restated KBI License\" shall have the meaning set forth in\nthe Recitals.\n\n         \"Annual Certificate\" shall have the meaning set forth in Section J.1.\n\n         \"Claims\" shall have the meaning set forth in Section O.1.\n\n         \"Clinical Quantities\" shall have the meaning set forth in the\nManufacturing Agreement.\n\n         \"Combination\" shall have the meaning set forth in the Amended and\nRestated KBI License.\n\n         \"Competing Compound\", with respect to any Distribution Compound, shall\nmean any Covered Compound having an approved indication within the same\nTherapeutic Category as such Distribution Compound.\n\n         \"Competing Product\" shall mean a product containing a Competing\nCompound.\n\n         \"Compound\" shall have the meaning set forth in the Amended and Restated\nKBI License.\n\n         \"De Minimis Infringement\" shall have the meaning set forth in the\nAmended and Restated KBI License.\n\n         \"Development Non-Performance Notice\" shall have the meaning set forth\nin Section D.2(a).\n\n         \"Discontinuation Notice\" shall have the meaning set forth in Section\nD.1(a) hereof.\n\n         \"Distribution Compound\" shall mean (i) each and every Compound that is\na Licensed Compound as of the date of this Agreement, (ii) each other Licensed\nCompound with respect to \n\n\n                                       4\n   7\nwhich the Partnership exercises its right under Section C or Section F hereof to\nbecome KBI-E's exclusive distributor and (iii) the Combination of enalapril and\nfelodipine, but shall not include (w) the Selected Compounds and the Selected\nUses of Licensed Compounds, (x) Compounds as to which the Partnership has\ndelivered a Rejection Notice, (y) other Compounds as to which the Partnership's\nrights as distributor hereunder have terminated pursuant to Section D hereof and\nas to which the Partnership has not been reappointed pursuant to Section F\nhereof or (z) enalapril as a monotherapy.\n\n         \"Distribution Product\" shall mean any pharmaceutical product that\ncontains any Distribution Compound, but shall not include any product to the\nextent such product is sold exclusively for a Selected Use.\n\n         \"Distribution Rights Option\" shall have the meaning set forth in\nSection C.1(a) hereof.\n\n         \"Events of Force Majeure\" shall have the meaning set forth in Section\nR.7.\n\n         \"Exclusive Second Look Product\" shall have the meaning set forth in the\nManufacturing Agreement.\n\n         \"Exempted Combination\" shall mean any Combination that is not a\nLicensed Compound.\n\n         \"Fee\" shall have the meaning set forth in Section B.2 hereof.\n\n         \"First Commercial Sale\" shall have the meaning set forth in the Amended\nand Restated KBI License.\n\n         \"Fiscal Year\" shall have the meaning set forth in the Partnership\nAgreement.\n\n         \"Full Costs\" shall have the meaning set forth in the Amended and\nRestated KBI License.\n\n         \"Group C Compounds\" shall have the meaning set forth in the Amended and\nRestated KBI License.\n\n         \"IND\" shall have the meaning set forth in the Amended and Restated KBI\nLicense.\n\n         \"Information Package\" shall have the meaning set forth in the Amended\nand Restated KBI License.\n\n         \"Intermediate Form\" shall have the meaning set forth in the KBI Supply\nAgreement.\n\n         \"KB\" shall have the meaning set forth in the Recitals.\n\n         \"KBI\" shall have the meaning set forth in the Recitals.\n\n         \"KBI Asset Contribution Agreement\" shall have the meaning set forth in\nthe Master Restructuring Agreement.\n\n\n                                       5\n   8\n         \"KBI Sublicense\" shall mean that certain KBI Limited Sublicense\nAgreement dated as of the date hereof between KBI-E and KBI, as such agreement\nis amended, modified, supplemented or restated from time to time.\n\n         \"KBI Supply Agreement\" shall mean that certain KBI Supply Agreement\ndated as of the date hereof, between KBI and the Partnership, as such agreement\nis amended, modified, supplemented or restated from time to time.\n\n         \"KBI-E\" shall have the meaning set forth in the Preamble.\n\n         \"KBI-E Asset Contribution Agreement\" shall have the meaning set forth\nin the Master Restructuring Agreement.\n\n         \"KBI-E Asset Option Agreement\" shall have the meaning set forth in the\nMaster Restructuring Agreement.\n\n         \"KBI-E Asset Purchase\" shall have the meaning set forth in the Master\nRestructuring Agreement.\n\n         \"KBI-E Assignment\" shall have the meaning set forth in the Recitals.\n\n         \"KBI-E Indemnitee\" shall have the meaning set forth in Section O.2.\n\n         \"Licensed Compound\" shall have the meaning set forth in the Amended and\nRestated KBI License.\n\n         \"Licensed Patents\" shall have the meaning set forth in the Amended and\nRestated KBI License, except that as used herein \"Licensed Patents\" shall not\ninclude any Licensed Patent that does not relate to the Distribution Compounds.\n\n         \"Losses\" shall have the meaning set forth in Section O.1.\n\n         \"Manufacturing Agreement\" shall have the meaning set forth in the\nMaster Restructuring Agreement.\n\n         \"Market Exclusivity\" shall have the meaning set forth in the Master\nRestructuring Agreement.\n\n         \"Marketing Approval\" shall mean with respect to a Distribution Compound\nor Distribution Product the approval by the FDA of an NDA with respect to such\nDistribution Compound or Distribution Product and any other regulatory or other\ngovernmental approvals, clearances, registrations and permits required for the\ncommercial marketing and sale of such Distribution Compound or Distribution\nProduct in the Territory.\n\n         \"Marketing Non-Performance Notice\" shall have the meaning set forth in\nSection D.2(b).\n\n\n                                       6\n   9\n         \"Master Restructuring Agreement\" shall mean the Master Restructuring\nAgreement dated as of June 19, 1998, among KB, TR, KBI, KBI-E, the Partnership\nand certain related parties, as such agreement is amended, modified,\nsupplemented or restated from time to time.\n\n         \"NDA\" shall have the meaning set forth in the Amended and Restated KBI\nLicense.\n\n         \"Net Sales\" shall have the meaning set forth in the Master\nRestructuring Agreement.\n\n         \"Non-Affiliate\" shall have the meaning set forth in the Amended and\nRestated KBI License.\n\n         \"Non-Exclusive Second Look Product\" shall have the meaning set forth in\nthe Manufacturing Agreement.\n\n         \"Non-Performance Notice\" shall have the meaning set forth in Section\nD.2 hereof.\n\n         \"Option Exercise Period\" shall have the meaning set forth in Section\nC.1 hereof.\n\n         \"Option Notice\" shall have the meaning set forth in the Amended and\nRestated KBI License.\n\n         \"Partnership\" shall have the meaning set forth in the Preamble.\n\n         \"Partnership Agreement\" shall have the meaning set forth in the Master\nRestructuring Agreement.\n\n         \"Partnership Indemnitee\" shall have the meaning set forth in Section\nO.1.\n\n         \"P&amp;G Agreements\" shall have the meaning set forth in the KBI Asset\nContribution Agreement.\n\n         \"Rejection Notice\" shall have the meaning set forth in Section C.1\nhereof.\n\n         \"Selected Compounds\" shall have the meaning set forth in the Selected\nCompounds Contribution Agreement.\n\n         \"Selected Compounds Contribution Agreement\" shall have the meaning set\nforth in the Master Restructuring Agreement.\n\n         \"sNDA\" shall mean a supplemental New Drug Application made in\naccordance with applicable regulations and requirements of the FDA as from time\nto time in effect.\n\n         \"Subsidiary\" shall have the meaning set forth in the Partnership\nAgreement.\n\n         \"Technical Information\" shall have the meaning set forth in the Amended\nand Restated KBI License.\n\n\n                                       7\n   10\n         \"Territory\" shall have the meaning set forth in the Amended and\nRestated KBI License.\n\n         \"Therapeutic Category\" shall mean each category of disease or disorder\nlisted on Exhibit D to the Amended and Restated KBI License. A Compound shall be\ndeemed to be in one or more Therapeutic Categories based on its approved\nindications.\n\n         \"Trademarks\" shall have the meaning set forth in the Amended and\nRestated KBI License.\n\n         \"Transfer\" shall have the meaning set forth in the Master Restructuring\nAgreement.\n\n         \"Trigger Event\" shall have the meaning set forth in the Master\nRestructuring Agreement.\n\n         Capitalized terms used but not defined in this Agreement shall have the\ndefinitions set forth in the Amended and Restated KBI License.\n\n\nB.       DISTRIBUTORSHIP\n\n         Notwithstanding any other provision of this Agreement, this Agreement\nand the rights of the Partnership hereunder are subordinate to, subject to and\nlimited by (i) the rights (and the limitations thereon) of KBI-E (as assignee of\nKBI) as Licensee under the Amended and Restated KBI License, and the Lexxel\nLicense, (ii) any Required Sublicense (as defined in the Amended and Restated\nKBI License) and (iii) the rights previously granted by KBI and KBI-E pursuant\nto the P&amp;G Agreements.\n\n\n         1.       Appointment of the Partnership as Distributor\n\n                  (a) Appointment. Subject to the provisions of Sections C, D\nand E hereof, KBI-E hereby appoints the Partnership as KBI-E's sole and\nexclusive distributor of Distribution Products in the Territory with the sole\nand exclusive right to promote, distribute, market and sell Distribution\nProducts in the Territory during the term of this Agreement, and all the rights\ngranted to KBI-E under the Amended and Restated KBI License with respect to\ndevelopment of Distribution Compounds (other than Selected Uses thereof), and\nthe right to obtain clinical supplies therefor, subject to the rights of KBI-E\npursuant to Sections D and E; provided, however, that the foregoing shall not be\nconstrued to prohibit the supply of Distribution Products and Distribution\nCompounds to the Partnership pursuant to Section B-1.1(e) hereof and pursuant to\nthe KBI Supply Agreement or the supply of Distribution Products (and\nIntermediate Forms thereof) and Distribution Compounds to KBI and other\nProducers pursuant to the Manufacturing Agreement. Subject to Sections C, D and\nF hereof, such appointment shall be effective on the date hereof with respect to\neach Compound that is a Licensed Compound under the Amended and Restated KBI\nLicense on the date hereof and, with respect to each Compound that thereafter\nbecomes a Distribution Compound, on the date that such Compound becomes a\nLicensed Compound or, in the case of Section F hereof, on the date that the\nPartnership notifies KBI-E that it desires to acquire or reacquire distribution\nrights hereunder and makes any payment required under such section. The\nPartnership hereby accepts such appointment as distributor.\n\n\n                                       8\n   11\n                  (b) No Implied Rights. The Partnership acknowledges that\nexcept as expressly provided herein, the Partnership shall not have or acquire\nby virtue of this Agreement any right, title, interest or license in, to or\nunder the Licensed Patents or Technical Information or any other intellectual\nproperty rights in the Distribution Compounds, and in no event shall this\nAgreement be deemed to be a license or sublicense of any rights under the\nAmended and Restated KBI License with respect to any Licensed Patents or\nTechnical Information or any other intellectual property rights in the\nDistribution Compounds.\n\n                  (c) Relationship of the Parties. Nothing in this Agreement\nshall be deemed to create a partnership, joint venture or relationship of\nprincipal and agent between the parties hereto. Nothing in this Agreement shall\nbe deemed to authorize either party hereto to make any representations or\nwarranties on behalf of or otherwise to act for, represent or bind the other\nparty hereto or any of its respective Affiliates in any manner whatsoever.\n\n                  (d) Marketing Obligation. Subject to the obligations of KBI as\nprovided in the KBI Supply Agreement and of the Producers as provided in the\nManufacturing Agreement, during the period of Market Exclusivity with respect to\na Distribution Compound, the Partnership shall use reasonable efforts to begin\nand to continue the marketing, distribution and sale of each such Distribution\nCompound in the Territory as promptly as practicable after the FDA has approved\nan NDA for such Distribution Compound. Following a Trigger Event, (i) reasonable\nefforts shall be determined by taking into account competition, the properties\nof the Distribution Compound, the approved claim structure for the Compound, the\nsales and profit potential of products containing such Distribution Compound\n(and Competing Compounds) and the nature and extent of market exclusivity and\n(ii) the amounts of marketing and promotional expenditures with respect to such\nDistribution Compound (and Competing Compounds) prior to the Trigger Event and\nother relevant factors also may be considered. The Partnership shall not,\nhowever, be required to market a Distribution Product if such Product is\ndiscontinued for reasons of safety or efficacy. For purposes of this Section\nB(1)(d), (i) a Compound shall be deemed to be in one or more Therapeutic\nCategories based on its approved indications, and (ii) subject to Section R.8,\nreasonable efforts with respect to any Distribution Compound in a Therapeutic\nCategory shall be satisfied if such efforts are used with respect to the\ntotality of Covered Compounds (taken as a whole) in such Therapeutic Category.\nIf the efforts employed by the Partnership for the totality of the Covered\nCompounds (taken as a whole) in a specific Therapeutic Category are reasonable\nin the aggregate, the requirement of reasonable efforts for each Distribution\nCompound in such Therapeutic Category will be deemed satisfied. The parties\nacknowledge and agree that neither the definition of \"Actively Marketing\" nor\nthe satisfaction of the tests set forth therein (including, without limitation,\nclause (ii) thereof) shall have any import or effect with respect to the\ndetermination of whether the Partnership has used reasonable efforts with\nrespect to the marketing, distribution and sale of Distribution Compounds as\nrequired by this Section B.1(d).\n\n\n                                       9\n   12\n         2.       Fee\n\n                  In connection with the appointment of the Partnership as\nKBI-E's distributor hereunder, the Partnership shall pay KBI-E on the Closing\nDate (as defined in the Master Restructuring Agreement) a one-time nonrefundable\nfranchise fee of Two Hundred Thirty Million U.S. Dollars (US$230,000,000.00)\n(the \"Fee\"), which Fee represents the full, final and complete consideration\npayable by the Partnership to KBI-E in consideration for the distribution rights\ngranted hereunder. The Fee shall be payable by the Partnership to KBI-E by wire\ntransfer to an account of KBI-E.\n\n\nB-1.     OPERATIONAL MATTERS\n\n         1.       (a) FDA Approval. The Partnership shall use reasonable efforts\nto obtain and maintain FDA approval of an NDA for each Distribution Compound for\nuse in human medicine. In furtherance thereof:\n\n                  (b) Evaluation. After receipt of appropriate documentation\nfrom the Licensor, the Partnership shall use reasonable efforts to file an IND\nwith the FDA at its sole cost in respect to each Distribution Compound. The\nPartnership acknowledges that under the terms of the Amended and Restated KBI\nLicense, the Licensor may, to the extent it deems required or advisable, also\nfile an IND with the FDA at its sole cost in respect of any Distribution\nCompound. The Partnership shall promptly notify the Licensor of each IND and NDA\nthe Partnership has filed and of each FDA approval of an NDA in respect of each\nDistribution Compound. The Partnership shall use reasonable efforts to complete\nas promptly as practicable its obligations set forth at subparagraphs (i) and\n(ii) below in a manner which complies with or exceeds FDA standards as from time\nto time in effect.\n\n         (i)      (A) If any tests, studies or other development activities to\n                  be performed by the Licensor pursuant to Section 3.1(a)(i) of\n                  the Amended and Restated KBI License for any Distribution\n                  Compound are required by the FDA to be performed in the\n                  Territory, the Partnership, at the request of the Licensor,\n                  shall use reasonable efforts to perform, or to contract for\n                  the performance of, such tests, studies or other development\n                  activities in the Territory, and KBI-E shall reimburse the\n                  Partnership for the Partnership's (or any of its\n                  Subsidiaries') out-of-pocket costs incurred in such\n                  performance to the extent not reimbursed by the Licensor\n                  directly pursuant to Section 3.1(a)(i) of the Amended and\n                  Restated KBI License.\n\n                  (B) The Amended and Restated KBI License provides that KB\n                  shall notify the Partnership of KB's Product Definition and\n                  Product Composition for such Distribution Compound as soon as\n                  reasonably available. If the Partnership desires a Product\n                  Definition different from the Licensor's Product Definition\n                  for such Distribution Compound, the Partnership shall consult\n                  with the Licensor and notify the Licensor of the Partnership's\n                  Product Definition for such Distribution Compound, which shall\n                  be reasonably related to the Licensor's Product Composition\n                  for such Distribution Compound. The Partnership shall\n                  reimburse \n\n\n                                       10\n   13\n                  KBI-E for (or, at the Partnership's option, pay directly to\n                  the Licensor) any amount that KBI-E is required to reimburse\n                  to the Licensor pursuant to Section 3.1(a)(i)(B) of the\n                  Amended and Restated KBI License in respect of the development\n                  of the Partnership's Product Definition for such Distribution\n                  Compound and in the development of the Dosage Form Information\n                  for such Product Definition (as such terms are defined in the\n                  Amended and Restated KBI License).\n\n                  (C) The Partnership will consult with the Licensor as to\n                  whether any tests, studies or other development activities of\n                  the nature described at subparagraph (A) above are required to\n                  be performed with respect to any reference drug or placebo for\n                  such Distribution Compound. The Partnership shall reimburse\n                  KBI-E for (or, at the Partnership's option, pay directly to\n                  the Licensor) any amount that KBI-E is required to pay to the\n                  Licensor pursuant to Section 3.1(a)(i)(C) of the Amended and\n                  Restated KBI License.\n\n                  (D) The Amended and Restated KBI License provides that the\n                  Licensor shall provide to the Partnership all appropriate\n                  documentation relating to the tests, studies and other\n                  development activities referred to in subparagraphs (A), (B)\n                  and (C) of Section 3.1(a) of the Amended and Restated KBI\n                  License for such Distribution Compound, including, without\n                  limitation, the results of, and supporting data and\n                  information for, all such tests, studies and other development\n                  activities. The Partnership shall be entitled to use such\n                  documentation and results, data and information to obtain or\n                  maintain FDA approval of an NDA for such Compound, and to\n                  incorporate such documentation and results, data and\n                  information in any filings with the FDA for such Compound.\n\n         (ii)     After Phase II Clinical Evaluation for a Distribution Compound\n                  has been completed, the Partnership shall use reasonable\n                  efforts to complete, (x) all Phase III Clinical Evaluation and\n                  (y) all tests and studies in humans, other than those\n                  contemplated by Section 3.1(a)(i) of the Amended and Restated\n                  KBI License, necessary or advisable to obtain and maintain FDA\n                  approval of an NDA for such Compound. The Partnership may,\n                  where special research and development expertise exists, after\n                  consultation with the Licensor, conduct outside the Territory\n                  specific tests and studies which are required by the FDA to be\n                  performed for Phase III Clinical Evaluation of such Compound;\n                  in such event, the Partnership shall agree with the Licensor\n                  on the appropriate regulatory documentation required to permit\n                  such tests and studies. After the completion of all tests,\n                  studies and other development activities and the preparation\n                  of all data and other information, necessary or appropriate to\n                  obtain FDA approval of an NDA for such Compound, the\n                  Partnership shall use reasonable efforts to obtain such\n                  approval.\n\n         (iii)    The Partnership shall provide the Licensor free-of-charge with\n                  such of the results of, and supporting data and information\n                  for, any tests and studies performed by \n\n\n                                       11\n   14\n                  the Partnership (or any of its Subsidiaries) pursuant to\n                  Section B-1(b)(ii) hereof for any Distribution Compound which\n                  the Licensor shall request after review with the Partnership\n                  of the material available, with authority to the Licensor, its\n                  Affiliates or any licensee or sublicensee thereof to use and\n                  make reference thereto.\n\n         (iv)     If, after manufacturing of any Distribution Compound has been\n                  commenced, there are changes in the method of synthesis, the\n                  final composition of dosage forms, or the Product Definition\n                  of such Distribution Compound such that the FDA requires any\n                  additional tests, studies or other development activities,\n                  then the Partnership shall use reasonable efforts to perform,\n                  at its own expense, such additional tests, studies or other\n                  development activities.\n\n                  (c) Regulatory Approval Cooperation. The Partnership\nrecognizes the Licensor's interest in maintaining a consistent profiling of each\nDistribution Compound worldwide and acknowledges KBI-E's obligations under\nSection 3.1(b) of the Amended and Restated KBI License in respect thereof. In\nfurtherance thereof, the Partnership shall, in respect of all tests, studies and\nother development activities to be performed in accordance with Section 3.1(a)\nof the Amended and Restated KBI License, consult with the Licensor on product\nprofiling. In addition, to the extent legal and practicable, the Partnership\nshall consult with the Licensor periodically to review the planning and the\nprogress of all preclinical and clinical tests, studies and other development\nactivities for each Distribution Compound. The Partnership shall (i) inform the\nLicensor of all meetings with representatives of the FDA concerning any\nDistribution Compound, (ii) arrange for representatives of the Licensor to\nattend such meetings as observers, and (iii) forward to the Licensor summaries\nof such meetings and copies of other significant communications with\nrepresentatives of the FDA concerning any Distribution Compound. The Amended and\nRestated KBI License provides that the Partnership shall be entitled to\nparticipate in such meetings between the Licensor and representatives of the FDA\nconcerning any Distribution Compound to the extent required by the Amended and\nRestated KBI License.\n\n                  (d) New Claims and Formulations. The Partnership shall consult\nwith the Licensor from time to time on an ad hoc basis regarding preclinical and\nclinical tests, studies and other development activities relating to additional\nclaims or formulations for any Distribution Compound for which approval of a new\nor supplemental NDA will be sought from the FDA.\n\n                  (e) Supply of Distribution Compounds and Distribution\nProducts. KBI-E shall cause Distribution Products and, solely for the purpose of\npermitting the Partnership to have made Special Combination Products (as defined\nin the Manufacturing Agreement), Distribution Compounds to be supplied to the\nPartnership by KBI on the terms and conditions and subject to the limitations\nset forth in the KBI Supply Agreement (the form of which, as to be entered into\nat the Closing, being attached hereto as Exhibit A), and, as hereinafter\nprovided, the Partnership shall purchase from KBI all of the Partnership's\nrequirements of each Distribution Product and such Distribution Compound in\naccordance with the terms and conditions of the KBI Supply Agreement, other than\nthe Partnership's requirements for Clinical Quantities of Distribution \n\n\n                                       12\n   15\nCompounds and Distribution Products. The Partnership shall enter into the KBI\nSupply Agreement with KBI, and KBI-E shall cause KBI to enter into the KBI\nSupply Agreement with the Partnership. KBI-E shall sublicense to KBI on a\nnon-exclusive basis such rights as may be held by KBI-E under the Amended and\nRestated KBI License from time to time as may be required to make or have made\nthe Distribution Products and Distribution Compounds for supply to the\nPartnership under the KBI Supply Agreement, subject to the limitations set forth\nin the KBI Supply Agreement. KBI-E shall not be deemed to be in breach of its\nobligations under this subsection (e) unless KBI is in breach of its obligations\nunder the KBI Supply Agreement. Notwithstanding the foregoing, KBI-E shall not\nhave any obligation to provide for the supply of any Compound or any product\ncontaining any Compound (other than candesartan cilexitil and the Combination of\nfelodipine and enalapril) if KBI-E does not have the right under the KBI\nSublicense to make or have made such Compound or product.\n\n                  (f) Quality in Marketing. The Partnership shall maintain\nstandards with respect to the quality of marketing and promotion of each\nDistribution Compound as follows: such standards shall be at least at a level\nequivalent to the standards then employed by the Licensor with respect to its\nCompounds, as such standards may be set forth by the Licensor by reasonable\nadvance notice to the Partnership from time to time. The Partnership shall\npermit the Licensor to have the marketing and promotional standards of the\nPartnership reviewed by a Non-Affiliate of the Licensor of nationally-recognized\nstanding (except a Non-Affiliate to whom the Partnership has some reasonable\nobjection) for the sole purpose of determining that this policy is followed. To\nthe extent legal, the Partnership shall furnish the Licensor for each\nDistribution Compound with monthly sales reports by dosage form and strength\nand, to the extent requested by the Licensor, copies of proposed labeling and\npackage inserts, and copies or other representations of advertising and other\npromotional materials.\n\n                  (g) Reports; Recordkeeping; Inspection. After the First\nCommercial Sale of any Distribution Compound for which royalties are payable to\nthe Licensor under Article VII of the Amended and Restated KBI License, the\nPartnership shall render to KBI-E and to the Licensor on behalf of KBI-E within\n20 days after the end of each calendar quarter a report for such quarter, which\nshall state, in reasonable detail, Net Sales of each Distribution Compound with\nrespect to which such royalties are payable and such other information as may be\nrequired to compute the amount of royalties due with respect to such quarter.\nThe Partnership shall keep, and shall cause its assignees and subdistributors to\nkeep, true, accurate and complete records of total quantities of Distribution\nCompounds sold and the Net Sales thereof in sufficient detail to permit\ndetermination of royalties payable under the Amended and Restated KBI License.\nAt the request and expense of KBI-E, KBI-E shall have the right for its then\ncurrently engaged independent accountants to have reasonable access at all\nreasonable times upon reasonable prior notice during normal business hours, to\naudit and examine, and make copies or extracts of and from the books, records\nand accounts of the Partnership and its Subsidiaries and subdistributors as may\nbe necessary in such accountants' judgment to permit them to attest that the\nroyalties paid or payable to the Licensor by KBI-E conform to the terms of the\nAmended and Restated KBI Agreement. Such rights of access, audit and inspection\nfor any Fiscal Year shall terminate three years after the close of each Fiscal\nYear in respect of royalties paid or payable for such Fiscal \n\n\n                                       13\n   16\nYear. KBI-E shall enter into a written engagement with such accountants, a copy\nof which shall be provided to the Partnership, providing that (i) the scope of\nthe engagement with respect to such audit and examination is limited to the\nrights provided in this Section B-1.1(g) and, if the audit is performed in\nconnection with another audit permitted by any other agreement between an\nAffiliate of KBI-E and the Partnership, the rights of such Affiliate under such\nother agreement, (ii) such accountants agree to use reasonable efforts,\nconsistent with their professional responsibility, the availability of materials\nand information and the level of assistance received, to conclude the audit and\nexamination within a reasonable period of time, and (iii) such accountants agree\nto keep any such information to which they have access pursuant to the foregoing\nconfidential and not to disclose to KBI-E or the Licensor (or any of their\nrespective Affiliates) any information other than information relating to the\nconformance of the Partnership's computation of Net Sales of each Distribution\nCompound with the terms of this Agreement and in no event shall quantities or\nprices or rebates to individual customers be disclosed to KBI-E or the Licensor\n(or any of their respective Affiliates) or any other Person. Notwithstanding the\nforegoing, KBI-E shall not, during the period from December 15 of any Fiscal\nYear through January 31 of the following Fiscal Year, exercise its rights of\naccess, audit and inspection under this Section and, during the period from\nFebruary 1 through the last day of February of any Fiscal Year, exercise such\nrights with respect to the activities of the Partnership during the last fiscal\nquarter of the prior Fiscal Year.\n\n                  (h) Transfer of Technical Information; Reactions. In the event\nthat the Licensor provides the Partnership with summaries of Technical\nInformation possessed by Licensor (or any of its Affiliates) regarding a\nDistribution Compound as contemplated by Article X of the Amended and Restated\nKBI License, the Partnership may transfer such Technical Information provided to\nit only to a subdistributor (and to no other Person except as provided herein),\nand may use such Technical Information solely in the Territory and only in\nfurtherance of its rights and obligations hereunder. The Partnership shall\npromptly, and in full accordance with FDA requirements, bring to the attention\nof the Licensor any unusual or unexpected reactions or side-effects with respect\nto each Distribution Compound and Combination containing any such Compound and\nto KBI-E in the use of any Compound which has ceased to be a Distribution\nCompound or as to which the Partnership's rights under this Agreement have\nbecome non-exclusive.\n\n                  (i) Regulatory Responsibility. Except as set forth in the\nManufacturing Agreement and the KBI Supply Agreement, the Partnership shall have\nresponsibility for compliance with all FDA and other regulatory requirements\nrelating to the manufacturing, marketing, sale, distribution, promotion and\ndevelopment of the Distribution Compounds and Distribution Products and for all\ncommunications with the FDA and other government agencies concerning the\nProducts.\n\n\nC.       OPTION WITH RESPECT TO GROUP C COMPOUNDS\n\n         1. (a) In the event the Licensor provides KBI-E with an Option Notice\nwith respect to a Group C Compound, KBI-E shall, upon receipt, promptly provide\nthe Partnership \n\n\n                                       14\n   17\nwith a copy thereof, and the Partnership shall have an option, exerciseable as\nset forth below, to cause such Compound to become a Distribution Compound and to\nbecome the sole and exclusive distributor with respect to Distribution Products\ncontaining such Distribution Compound as provided in this Agreement (the\n\"Distribution Rights Option\"). The Partnership shall have thirty (30) days from\nreceipt of such Option Notice from KBI-E (the \"Option Exercise Period\") in which\nto determine whether to exercise the Distribution Rights Option.\n\n                  (b) In the event the Partnership delivers to KBI-E written\nnotice prior to the expiration of the Option Exercise Period that it does not\nwish to exercise the Distribution Rights Option with respect to such Compound (a\n\"Rejection Notice\"), such Compound shall not become a Distribution Compound, and\nthe Partnership shall not be the distributor of, or have any other rights or any\nobligations under this Agreement with respect to, such Compound or products\ncontaining such Compound. In such event, KBI-E may determine in its sole\ndiscretion whether or not to exercise the option with respect to which the\nOption Notice was given.\n\n                  In the event the Partnership does not deliver to KBI-E a\nRejection Notice prior to the expiration of the Option Exercise Period, KBI-E\nshall cause the option with respect to such Compound under Section 2.3 of the\nAmended and Restated KBI License to be exercised. Upon such Compound becoming a\nLicensed Compound, such Compound shall be a Distribution Compound, and the\nPartnership shall, without any further action by KBI-E or the Partnership, be\nKBI-E's sole and exclusive distributor with respect to Distribution Products\ncontaining such Compound as and to the extent provided in Section B.1. KBI-E\nshall not have any right to obtain from the Partnership, nor shall it have any\nother rights hereunder with respect to, the Information Package or any samples\nand scientific, technical and other information made available to the\nPartnership pursuant to Section 2.3 of the Amended and Restated KBI License,\nthis Section C.1 or otherwise with respect to such Compound.\n\n\nD.       REVERSION AND TERMINATION OF RIGHTS WITH RESPECT TO DISTRIBUTION \n         COMPOUNDS\n\n         1. (a) At any time after the Partnership shall have determined (i) that\nit is neither (A) currently conducting or planning to conduct an Active\nDevelopment Program for a Distribution Compound or a Competing Compound nor (B)\nActively Marketing or planning to Actively Market any Distribution Product\ncontaining such Distribution Compound or any product containing a Competing\nCompound or (ii) to discontinue the development or marketing of such\nDistribution Compound and any Distribution Product containing such Distribution\nCompound, the Partnership may deliver to KBI-E a written notice (a\n\"Discontinuation Notice\") identifying such Distribution Compound and\nDistribution Products containing such Distribution Compound, if any, but\nexcluding any Exempted Combination. Upon delivery of a Discontinuation Notice\nwith respect to such Distribution Compound (i) if such delivery is prior to the\nFirst Commercial Sale of any Distribution Product containing such Distribution\nCompound, such Distribution Compound shall cease to be a Distribution Compound,\nand (ii) if such delivery is subsequent to the First Commercial Sale of any\nDistribution Product containing such Distribution Compound, the rights of the\nPartnership with respect to such Distribution \n\n\n                                       15\n   18\nCompound and Distribution Products containing such Distribution Compound shall\nbecome non-exclusive.\n\n                  (b) In the event KB notifies KBI pursuant to Section\n3.01(c)(iv) of the Manufacturing Agreement that it declines to perform the\nManufacturing Stages referred to in Section 3.01(c)(i)(A)(1) or (2) of the\nManufacturing Agreement with respect to any KB Pipeline Product of the\nManufacturing Agreement, and does not thereafter become the Producer with\nrespect to such Manufacturing Stage or Stages for such KB Pipeline Product by\ngiving notice of its election to become the Producer with respect thereto and\nagreeing to match the pricing of the Alternate Producer and to reimburse KBI and\nits Affiliates for the reasonable out-of-pocket costs of KBI and its Affiliates\nassociated with retaining such Alternate Producer in accordance with Section\n3.01(c)(iv) of the Manufacturing Agreement, such Distribution Compound shall\ncease to be a Distribution Compound.\n\n         2.       (a) At any time after the first anniversary of the date that a\nCompound becomes a Distribution Compound (excluding any Exempted Combination)\nand prior to the First Commercial Sale thereof, KBI-E may deliver to the\nPartnership a written notice with respect to such Distribution Compound setting\nforth its contention that the Partnership was not during the most recent Fiscal\nYear ended prior to such notice (or, in the event that the Partnership has\nprovided to KBI-E pursuant to Section J hereof an Annual Certificate that was\nmaterially inaccurate and was prepared with reckless disregard for the accuracy\nor inaccuracy of the information contained therein, the two most recently\ncompleted Fiscal Years) conducting an Active Development Program for such\nDistribution Compound or a Competing Compound (a \"Development Non-Performance\nNotice\"); provided, however, that for the Fiscal Year during which a Compound\nbecomes a Distribution Compound the requirements for the Active Development\nProgram in respect of such Distribution Compound shall be pro rated in relation\nto the portion of such calendar year during which the Compound was a\nDistribution Compound.\n\n                  (b) At any time after the expiration of 33 months following\nthe date of the First Commercial Sale of any Distribution Product containing a\nDistribution Compound, KBI-E may deliver to the Partnership a written notice\nwith respect to such Distribution Compound setting forth its contention that the\nPartnership was not during the most recent Fiscal Year completed prior to such\nnotice (or, in the event that the Partnership has provided to KBI-E pursuant to\nSection J hereof an Annual Certificate that was materially inaccurate and was\nprepared with reckless disregard for the accuracy or inaccuracy of the\ninformation contained therein, the two most recently completed Fiscal Years)\nActively Marketing any Distribution Product containing such Distribution\nCompound or any product containing a Competing Compound (a \"Marketing\nNon-Performance Notice\").\n\n                  (c) As used herein, \"Non-Performance Notice\" shall mean a\nDevelopment Non-Performance Notice or a Marketing Non-Performance Notice. Any\nFiscal Year with respect to which KBI-E is permitted to give a Non-Performance\nNotice pursuant to subsection (a) or (b) above may be designated at the election\nof KBI-E in its Non-Performance Notice or otherwise in writing as a \"Measurement\nYear.\" In the event that KBI-E has exercised its right of audit with \n\n\n                                       16\n   19\nrespect to any Fiscal Year pursuant to Section J.2, any Non-Performance Notice\nwith respect to such Fiscal Year must be delivered within 30 days after the\ncompletion of such audit and the delivery of the auditors' report with respect\nthereto. Any Non-Performance Notice delivered after such 30-day period shall be\nof no effect.\n\n                  (d) Within ninety (90) days after receipt of a Non-Performance\nNotice, the Partnership shall deliver to KBI-E a written notice that either (i)\nconfirms KBI-E's claim as set forth in such Non-Performance Notice or (ii)\ndisputes KBI-E's claim (a \"Dispute Notice\"). If KBI-E has delivered a\nDevelopment Non-Performance Notice and (i) the Partnership does not deliver a\nDispute Notice with respect thereto to KBI-E within such ninety-day period, or\n(ii) the Partnership confirms that during the applicable Measurement Year it was\nneither conducting an Active Development Program for such Distribution Compound\nor a Competing Compound nor Actively Marketing any Distribution Product\ncontaining such Distribution Compound or a Competing Compound, such Distribution\nCompound shall cease to be a Distribution Compound. If KBI-E has delivered a\nMarketing Non-Performance Notice and (i) the Partnership does not deliver a\nDispute Notice with respect thereto to KBI-E within such ninety-day period, or\n(ii) the Partnership confirms that during the applicable Measurement Year it was\nneither conducting an Active Development Program for such Distribution Compound\nor a Competing Compound nor Actively Marketing such Distribution Compound or a\nCompeting Compound, the rights of the Partnership with respect to such\nDistribution Compound and Distribution Products containing such Distribution\nCompound shall become non-exclusive.\n\n                  (e) In the event the Partnership shall have delivered a\nDispute Notice, the parties shall co-operate in good faith to resolve such\ndispute. If, in the case of a Development Non-Performance Notice, the parties\nare unable to resolve the dispute set forth in the Dispute Notice within 30 days\nafter the delivery of such Dispute Notice, such dispute shall be resolved by\narbitration pursuant to Section Q. Such arbitration shall be initiated by KBI-E\nwithin thirty (30) days after receipt by KBI-E of such notice. If, in the case\nof a Marketing Non-Performance Notice, the parties are unable to resolve the\ndispute set forth in the Dispute Notice within 180 days after the delivery of\nsuch Dispute Notice, such dispute shall be resolved by arbitration pursuant to\nSection Q. Such arbitration shall be initiated by KBI-E no earlier than 180 days\nand no later than 210 days after receipt by KBI-E of such Dispute Notice.\n\n                  (f) With respect to a dispute concerning a Development\nNon-Performance Notice, if the arbitrators determine that the Partnership was\nduring the applicable Measurement Year conducting an Active Development Program\nfor such Distribution Compound or a Competing Compound or was Actively Marketing\nany Distribution Product containing such Distribution Compound or any product\ncontaining a Competing Compound, the rights of the Partnership under this\nAgreement with respect to such Distribution Compound shall continue to be\nexclusive. If the arbitrators determine that during the applicable Measurement\nYear the Partnership was neither conducting an Active Development Program for\nsuch Distribution Compound or a Competing Compound nor Actively Marketing any\nDistribution Product containing such Distribution Compound or any product\ncontaining a Competing Compound, such Distribution Compound shall cease to be a\nDistribution Compound.\n\n\n                                       17\n   20\n                  (g) If a Marketing Non-Performance Notice is given with\nrespect to a Distribution Compound during the first 15 months following the\nexpiration of the thirty-three month period referred to in Section D.2(b), the\nrights of the Partnership with respect to such Distribution Compound and\nproducts containing such Distribution Compound shall become non-exclusive if the\narbitrators determine that (i) during the thirty-six month period referred to in\nclause (ii) of the definition of \"Actively Marketing\" the Partnership was not\nActively Marketing Distribution Products containing such Distribution Compound\nor products containing a Competing Compound, (ii) the Partnership was not during\nthe Measurement Year conducting an Active Development Program for such\nDistribution Compound or a Competing Compound and (iii) at the time the notice\nof initiation of the arbitration proceeding was given by KBI-E the Partnership\nwas neither conducting an Active Development Program for such Distribution\nCompound or a Competing Compound nor Actively Marketing Distribution Products\ncontaining such Distribution Compound or products containing a Competing\nCompound. If a Marketing Non-Performance Notice is given with respect to a\nDistribution Compound at any other time thereafter, the rights of the\nPartnership with respect to such Distribution Compound and products containing\nsuch Distribution Compound shall become non-exclusive if the arbitrators\ndetermine that at the time the notice of initiation of the arbitration\nproceeding was given by KBI-E, the Partnership was not Actively Marketing\nDistribution Products containing such Distribution Compound or products\ncontaining a Competing Compound and during the Measurement Year the Partnership\nwas not conducting an Active Development Program for such Distribution Compound\nor a Competing Compound and was not Actively Marketing Distribution Products\ncontaining such Distribution Compound or products containing a Competing\nCompound.\n\n                  (h) KBI-E may deliver a Non-Performance Notice to the\nPartnership with respect to any given Distribution Compound (and seek resolution\nof any dispute arising therefrom pursuant to subparagraph (e) above) only once\nduring the development of such Distribution Compound and only once during the\nmarketing of a Distribution Product containing such Distribution Compound.\n\n                  (i) The rights of KBI-E pursuant to Section D shall not apply\nto (A) remacemide with respect to the conduct of an Active Development Program\nor to candesartan cilexitil or (B) any Group C Compound in-licensed or acquired\nby KB or any of its Affiliates (other than the Partnership) in the event that\nthe applicable license or acquisition agreement contains (x) payment obligations\nother than payments computed as a percentage of Net Sales in the Territory, or\nrelating to the supply, purchase or delivery of Distribution Compound or\nDistribution Product for sale in the Territory (an example of such payment\nobligation is a lump sum payment triggered by filings, approvals or other events\nor development activities in the Territory) or (y) obligations that may require\nthe licensee, sublicensee, distributor or subdistributor to grant back to any\nNon-Affiliate of KB from which the Compound has been acquired or licensed (or to\nany of its Affiliates), any right, title or interest in Compound Intellectual\nProperty (as defined in the Master Restructuring Agreement), Compound Technical\nInformation (as defined in the Master Restructuring Agreement), NDAs, INDs,\nsNDAs or any other technology, improvements, intellectual property or processes\nrelating to such Distribution Compound or Distribution Product.\n\n\n                                       18\n   21\n         3.       (a) In the event a Compound ceases to be a Distribution \nCompound or the Partnership's rights hereunder become non-exclusive with respect\nto a Distribution Compound, KBI-E shall be free to develop such Compound for its\nown benefit and to market, sell and promote any products containing such \nCompound for its own benefit under any trademark of its choosing, subject to the\nterms of the Amended and Restated KBI License, (except that, without the consent\nof the Partnership, KBI-E shall not use any trademark used by the Partnership or\nany of its Affiliates in respect of any such product or any trademark \nconfusingly similar thereto) or to appoint one or more other distributors with \nrespect to such Compound and products containing such Compound or to grant one \nor more sublicenses of all its rights with respect thereto; provided, however, \nthat any agreement appointing such distributor or granting any such sublicense \nwith respect to such Compound (other than agreements relating to omeprazole or\nperprazole) shall be terminable at the option of KB if such Compound is\npurchased as a \"Discretionary Compound\" in connection with the consummation of\nthe KBI-E Asset Purchase; and provided, further, that prior to the KBI-E Asset\nPurchase, KBI-E shall not appoint any such distributor or grant any such\nsublicense to any person that is not an Affiliate of KBI-E.\n\n                  (b) If a Compound ceases to be a Distribution Compound, (i)\nthe Partnership shall, subject to the provisions of Section E, as promptly as\npracticable following the date on which such Compound ceases to be a\nDistribution Compound, transfer to KBI-E the items specified in Section 13.3 of\nthe Amended and Restated KBI License with respect to such Compound and (ii) upon\nthe demand of KBI-E, the Partnership shall deliver to KBI-E (A) samples of such\nCompound and products, if any, containing such Compound and such scientific,\ntechnical and other information in the Partnership's possession relating to such\nCompound and such products and (B) copies of all promotional materials,\nmarketing plans, marketing studies, product samples, product development studies\nand other information with respect to such Compound or products.\n\n                  (c) If the rights of the Partnership with respect to a\nDistribution Compound become non-exclusive pursuant to this Section D, (i) the\nPartnership shall, subject to the provisions of Section E, as promptly as\npracticable following the date on which such rights become non-exclusive,\ntransfer to KBI-E copies of all Technical Information and of other confidential\ninformation covered by Section 10.2 of the Amended and Restated KBI License\nfurnished by the Licensor or any of its Affiliates to the Partnership concerning\nsuch Distribution Compound and (ii) upon the demand of KBI-E, the Partnership\nshall deliver to KBI-E samples of such Compound and products, if any, containing\nsuch Compound and such scientific, technical and other information in the\nPartnership's possession relating to such Compound and such products.\n\n                  (d) In the event the Partnership and its Affiliates transfer\nto KBI-E all applicable INDs and NDAs with respect to a Compound pursuant to\nSection E.2, such Compound shall cease to be a Distribution Compound, and the\nrights of the Partnership with respect to such Compound shall terminate.\n\n\n                                       19\n   22\n         4. If a Compound ceases to be a Distribution Compound, KBI-E shall, not\nlater than 30 days after such rights terminate, purchase from the Partnership at\nthe Partnership's cost, such of the Partnership's inventory of finished goods of\nproducts containing such Compound (including samples) as is in good and saleable\ncondition and in a quantity that, assuming annual sales equal to the average\nannual sales of such products for the three most recent Fiscal Years of the\nPartnership, would be sold prior to the expiry date thereof. KBI-E (or any\nAffiliate that KBI-E may appoint as a distributor or sublicensee with respect\nthereto) shall be entitled to continue to use the existing packaging and trade\ndress of such Distribution Products (including the name of the Partnership set\nforth therein) until the final disposition of such inventory. Payment shall be\nmade concurrently with the acceptance of such Distribution Products by KBI-E.\n\n         5. If the rights of the Partnership with respect to a Distribution\nCompound become non-exclusive pursuant to this Section D or if a Compound ceases\nto be a Distribution Compound but the Partnership retains rights with respect to\nany Exempted Combination, each party shall report to the other all Adverse Drug\nExperiences that come to its attention or the attention of any of its Affiliates\nand shall furnish the other party with copies of all reports to the FDA made by\nit or any of its Affiliates with respect to such Licensed Compound.\n\n         6. If a Compound ceases to be a Distribution Compound, the\nPartnership's rights under this Agreement with respect to such Compound shall\nterminate and the Partnership shall cease to be the distributor hereunder with\nrespect to such Compound or products containing such Compound.\n\n         7. If the license with respect to a Discontinued Licensed Compound or\nLicensed Compound (as such terms are defined in the Amended and Restated KBI\nLicense) is terminated pursuant to Section 16.2 of the Amended and Restated KBI\nLicense, the Partnership shall transfer to KB all rights which the Partnership\nshall have with respect to any uses of such Licensed Compound or Discontinued\nLicensed Compound, as the case may be, so that KB shall be in possession of all\nrights with respect to such Licensed Compound, including the Selected Uses of\nsuch Licensed Compound and any Exempted Combinations thereof.\n\n\nE.       INDS AND NDAS\n\n         1. If a Compound ceases to be a Distribution Compound, the Partnership\nshall, as promptly as practicable following the occurrence of any such event,\ntransfer, or cause to be transferred, to the extent permitted by applicable law\nand regulations and requirements of the FDA, to KBI-E the INDs and NDAs for such\nCompound registered in the Partnership's name; provided, however, that\nnotwithstanding the foregoing, the Partnership and its subdistributors, if any,\nshall be entitled to a right of reference with respect to the NDA and the drug\nmaster file for any such Compound which has been transferred to KBI-E in\naccordance with this Agreement in order to enable the Partnership and its\nsubdistributors to make, have made, use and sell the Selected Uses of such\nCompound and develop and market any Exempted Combination.\n\n         2. In the event the Partnership's rights hereunder become non-exclusive\nwith respect to a Distribution Compound, the Partnership shall, at the request\nof KBI-E, appoint KBI-E or its \n\n\n                                       20\n   23\ndesignee as a distributor under all NDAs for such Compound and products\ncontaining such Compound. In addition, KBI-E shall have the right of reference\nto such NDAs and the Partnership's drug master file with respect to such\nCompound and shall have all such other rights under such NDAs and other\nregulatory filings of the Partnership and its Affiliates with respect to such\nCompound as may be necessary or convenient to KBI-E or its other distributor or\nsublicensee in connection with the development, marketing, promotion or sale of\nsuch Compound or products containing such Compound. At the Partnership's sole\ndiscretion, the Partnership shall, to the extent permitted by applicable law and\nregulations and requirements of the FDA, either (i) keep such NDAs in full force\nand effect or (ii) transfer or cause to be transferred to KBI-E the INDs and\nNDAs for such Compound registered in the name of the Partnership or any\nAffiliate of the Partnership. In the event the Partnership and its Affiliates\ntransfer to KBI-E all applicable INDs and NDAs with respect to a Compound\npursuant to this Section E.2, Section D.3(d) shall apply with respect to such\nCompound.\n\n         3. Prior to delivery of a Discontinuation Notice by the Partnership to\nKBI-E pursuant to Section D.1 for a Compound or delivery of a Non-Performance\nNotice to the Partnership by KBI-E, the Partnership may withdraw any INDs or\nNDAs with respect to any such Compounds at any time. After delivery of a\nDiscontinuation Notice by the Partnership to KBI-E pursuant to Section D.1 for a\nCompound or delivery of a Non-Performance Notice by KBI-E to the Partnership\nwith respect to a Compound and before the time, if any, when such Compound\nceases to be a Distribution Compound or the rights of the Partnership hereunder\nwith respect to such Compound become non-exclusive, the Partnership may withdraw\nsuch INDs or NDAs only (x) for safety concerns, (y) for liability concerns with\nrespect to which external legal counsel has advised the Partnership that there\nis a reasonable likelihood that it would be subject to potential liability if it\ndid not withdraw such INDs or NDAs or (z) pursuant to a recommendation of the\nFDA.\n\n\nF.       REAPPOINTMENT OF PARTNERSHIP AS DISTRIBUTOR\n\n         1. (a) In the event (i) a Compound ceases to be a Distribution Compound\nand the rights of the Partnership with respect to such Distribution Compound\nterminate pursuant to Section D prior to the First Commercial Sale of\nDistribution Products containing such Compound and (ii) KBI-E or an Affiliate of\nKBI-E subsequently develops such Compound, KBI-E shall offer the Partnership an\noption to reacquire exclusive distribution rights with respect to such Compound\nand Distribution Products containing such Compound in accordance with Section\nB.1. Such offer shall be made by written notice to the Partnership (x) promptly\nfollowing the completion of the design of the Phase III Clinical Evaluation with\nrespect to such Compound and (y) immediately prior to the filing of an NDA for\nsuch Compound. In the case of (x) and (y) above, KBI-E shall simultaneously make\navailable to the Partnership such samples of such Compound and Distribution\nProducts containing such Compound and such scientific, technical and other\ninformation in KBI-E's (or any of its Affiliates') possession relating to such\nCompound and Distribution Products containing such Compound for the sole purpose\nof allowing the Partnership to determine whether to exercise the option pursuant\nto this Section with respect to such Compound and Distribution Products\ncontaining such Compound and, in the \n\n\n                                       21\n   24\ncase of (y) above, KBI-E shall simultaneously make available to the Partnership\nthe IND or NDA for such Compound in the form in which KBI-E proposes to file\nsuch IND or NDA with the FDA.\n\n                  (b) In the event the Partnership notifies KBI-E in writing not\nlater than sixty (60) days after the receipt of such notice from KBI-E that the\nPartnership wishes to reacquire such distribution rights and pays to KBI-E the\nReappointment Payment (as defined in paragraph (c) below), the Partnership\nshall, without any further action by KBI-E or the Partnership, be KBI-E's sole\nand exclusive distributor hereunder in accordance with Section B.1 with respect\nto such Licensed Compound and any Distribution Products containing such\nCompound. In the event the Partnership gives such notice and pays to KBI-E the\nReappointment Payment, (i) such Licensed Compound shall be deemed a Distribution\nCompound and such Distribution Compound and any Distribution Products containing\nsuch Distribution Compound shall be deemed to be subject to the terms of this\nDistribution Agreement; (ii) the INDs and NDAs for such Distribution Compound\nregistered in the name of KBI-E (or any of its Affiliates) shall, as promptly as\npracticable following the occurrence of any such event, be transferred, to the\nextent permitted by applicable law and regulations and requirements of the FDA,\nto the Partnership.\n\n                  (c) The Reappointment Payment shall be the greater of (x) the\nfair market value of the distribution rights with respect to Distribution\nProducts containing such Distribution Compound and (y) the Full Costs incurred\nby KBI-E and its Affiliates in connection with any development work previously\nundertaken by KBI-E and its Affiliates with respect to such Compound,\ncompounding capitalized amounts at the pre-tax cost of capital; provided,\nhowever, that for purposes of computing the cost of capital component of such\nFull Costs, all investigative, research and development expenses incurred by\nKBI-E or any of its Affiliates in connection with such Compound shall be\ncapitalized. For purposes of this Section F, the \"fair market value\" of such\ndistribution rights shall mean the net present value of the future pre-tax cash\nflows of such Distribution Compound and any Distribution Products containing\nsuch Compound as if KBI-E had continued to develop and sell such Compound and\nDistribution Products itself, less the net present value of the Agreed Mark Up\n(as defined in the KBI Supply Agreement) relating to such Distribution Products\nto be paid by the Partnership to KBI under the KBI Supply Agreement after the\ndistribution rights with respect to such Distribution Products are reacquired by\nthe Partnership. Such net present value shall be determined by an appraiser\n(selected in accordance with Section 3.15(f) of the Master Restructuring\nAgreement) using the prevailing pre-tax cost of capital (as determined by such\nappraiser) for leading United States pharmaceutical companies.\n\n                  (d) Section D shall not apply to any Compound for which the\nPartnership has been reappointed as distributor pursuant to this Section F.\n\n\nG.       DEVELOPMENT COSTS\n\n         In the event KBI-E obtains rights to any Distribution Compound and any\nDistribution Products containing such Distribution Compound pursuant to the\nterms set forth in Section C or D, KBI-E will not be required to reimburse the\nPartnership for any development or other similar costs associated with such\nDistribution Compound or any such Distribution Product.\n\n\n                                       22\n   25\nH.       TRADEMARKS\n\n         In the event that (i) a Compound ceases to be a Distribution Compound\nand the rights of the Partnership with respect to such Distribution Compound\nterminate, (ii) the Partnership's rights under the Amended and Restated KBI\nLicense with respect to any Trademark used or associated with such Distribution\nCompound or any other Trademark used or associated with such Distribution\nCompound have been distributed by the Partnership to the Limited Partner of the\nPartnership pursuant to Section 5.10 of the Partnership Agreement, and (iii) the\nPartnership reacquires distribution rights with respect to any such Compound and\nDistribution Products containing such Compound pursuant to Section F, such\nrights under the Amended and Restated KBI License to such Trademarks relating to\nsuch Compound and Distribution Products shall be assigned to the Partnership and\nthe corresponding obligations thereunder relating to such Trademarks shall be\nassumed by the Partnership pursuant to an instrument of assignment and\nassumption substantially in the form set forth as Exhibit A hereto.\n\n\nI.       INFRINGEMENT\n\n         1. The Partnership shall give prompt notice to KBI-E of any\ninfringement, potential infringement or suspected infringement with respect to\nany Licensed Patent, except for any De Minimis Infringement, that may come to\nthe Partnership's attention. The Partnership shall reimburse KBI-E for 50% of\nthe out-of-pocket expenses incurred by it in connection with the performance by\nit of any actions required to be taken by it pursuant to Section 9.1(b) of the\nAmended and Restated KBI License, to the extent not reimbursed by the Licensor.\n\n         2. If KBI-E receives any recovery pursuant to Section 9.2(g) of the\nAmended and Restated KBI License with respect to a Distribution Compound, (i) in\nthe event KBI-E has been reimbursed for its expenses in connection with the\nmatter to which such recovery relates pursuant to Section 9.2(g) of the Amended\nand Restated KBI License, that portion of the recovery that is not allocated to\nthe Licensor pursuant to the Amended and Restated KBI License shall be allocated\nbetween KBI-E and the Partnership as follows: 56.25% shall be allocated to the\nPartnership in the case of matters relating to a Group C Compound (55% in the\ncase of matters relating to a Group A Compound or Group B Compound) and 43.75%\nshall be allocated to KBI-E in the case of matters relating to a Group C\nCompound (45% in the case of matters relating to a Group A or Group B Compound);\nor (ii) in the event KBI-E has not been reimbursed for its expenses in\nconnection with such matter, such recovery (net of KBI-E's expenses in\nconnection with such matter) shall be allocated between KBI-E and the\nPartnership as follows: 56.25% shall be allocated to the Partnership in the case\nof matters relating to a Group C Compound (55% in the case of matters relating\nto a Group A Compound or Group B Compound) and 43.75% shall be allocated to\nKBI-E in the case of matters relating to a Group C Compound (45% in the case of\nmatters relating to a Group A or Group B Compound).\n\n\nJ.       COMPLIANCE CERTIFICATE; AUDIT RIGHTS\n\n         1. The Partnership shall deliver to KBI-E in accordance with Section\nR.4 hereof, within sixty (60) days after the end of each Fiscal Year of the\nPartnership a certificate executed \n\n\n                                       23\n   26\nby the chief executive officer or other senior executive officer of the\nPartnership or by the general partner of the Partnership certifying as to each\nDistribution Compound whether or not the Partnership, as of the end of such\nFiscal Year, is (A) conducting an Active Development Program for such\nDistribution Compound or a Competing Compound and (B) Actively Marketing\nDistribution Products containing such Distribution Compound or products\ncontaining a Competing Compound (an \"Annual Certificate\"), which certificate may\nbe a combined certificate with respect to all Distribution Compounds. Such\ncertificate shall (A) identify each such Distribution Compound, Distribution\nProduct, Competing Compound and Competing Product, (B) certify whether the\namount of the Partnership's (and its Affiliates') development expenditures for\nsuch Fiscal Year in respect of such Distribution Compound exceed the $1 million\nand $3 million amounts for the applicable development phase described in the\ndefinition of \"Active Development Program,\" (C) identify the applicable\ndevelopment phase for such Compound and (D) in the case of a Distribution\nCompound for which the Partnership is not conducting an Active Development\nProgram and a Distribution Product that is not being Actively Marketed by the\nPartnership, identify any Competing Compound or Competing Product, the\napplicable Therapeutic Categories therefor, for which the Partnership is\nconducting an Active Development Program or which the Partnership is Actively\nMarketing.\n\n         In the event such certificate does not certify that the Partnership is\neither (i) conducting an Active Development Program for such Distribution\nCompound or a Competing Compound or (ii) Actively Marketing Distribution\nProducts containing such Distribution Compound or a Competing Compound, the\ndelivery of such certificate shall be deemed to be the delivery of a\nDiscontinuation Notice with respect to such Distribution Compound provided,\nhowever, that if such certificate omits the certification with respect to any\nCompound the failure to deliver such certificate shall not constitute the\ndelivery of a Discontinuation Notice unless the Partnership fails to deliver\nsuch certification within thirty (30) days after the delivery to the Partnership\nof notice of such omission. In the event the Partnership fails to deliver to\nKBI-E within the 60-day period referred to in this Section J.1 an Annual\nCertificate with respect to each Distribution Compound and fails to deliver such\nAnnual Certificate within thirty (30) days after written notice from KBI-E of\nsuch failure to deliver or if the Annual Certificate with respect to a year was\nprepared with reckless disregard for the accuracy or inaccuracy of the\ninformation contained therein, the Partnership shall reimburse KBI-E for the\nFull Cost of any audit by KBI-E's accountants pursuant to Section J.2 with\nrespect to such Fiscal Year.\n\n         2. The Partnership shall keep, and shall cause its Affiliates and\nsubdistributors to keep, true, accurate and complete records of the development\nand marketing expenditures and commitments therefor in respect of each\nDistribution Compound and Competing Compound and each Distribution Product (and\nthe Distribution Compound contained therein) or product containing a Competing\nCompound (and the Competing Compound contained therein) in sufficient detail to\npermit the verification of the information contained or required to be contained\nin the certificate provided to KBI-E pursuant to Section J.1. Upon KBI-E's\nrequest, the Partnership shall permit (and shall cause its Affiliates and\nsubdistributors to permit) an independent certified public accountant selected\nand paid by KBI-E (except one to whom the Partnership has some reasonable\nobjection) to have reasonable access to, examine and copy \n\n\n                                       24\n   27\nduring ordinary business hours such of the Partnership's and its Affiliates' and\nsubdistributors' books and records as may be necessary or advisable in such\naccountant's judgment to confirm to its reasonable satisfaction and attest the\naccuracy of any certificate delivered to KBI-E pursuant to this Section J. This\nright to request a review for any Fiscal Year shall be effective only with\nrespect to the immediately preceding Fiscal Year and shall terminate one (1)\nyear after the end of such Fiscal Year, unless it is determined by arbitration\nthat the Annual Certificate for a Fiscal Year was prepared with reckless\ndisregard for the accuracy or inaccuracy of the information contained therein,\nin which case, such right of review shall be effective for the two (2) preceding\nFiscal Years. Such examination may commence with respect to a Fiscal Year only\nafter the earlier of the delivery of the Annual Certificate with respect to such\nFiscal Year or the due date for such Annual Certificate. KBI-E shall enter into\na written engagement with such accountants, a copy of which shall be provided to\nthe Partnership, providing that (i) the scope of the engagement with respect to\nsuch audit and examination is limited to the rights provided in this Section J\nand, if the audit is performed in connection with another audit permitted by any\nother agreement between an Affiliate of KBI-E and the Partnership, the rights of\nsuch Affiliate under such other agreement, (ii) such accountants agree to use\nreasonable efforts, consistent with their professional responsibility, the\navailability of materials and information and the level of assistance received,\nto conclude the audit and examination within a reasonable period of time, and\n(iii) such accountants agree to keep its findings confidential and shall not\ndisclose to KBI-E (or any of its Affiliates) any information except that it\nshall report to KBI-E (i) its findings and any other information relating to the\naccuracy of the certificate delivered under this Section J and the conformance\nof such certificate to the terms of this Agreement, (ii) interpretations of the\nterms of this Agreement applied by the Partnership to the information contained\nin and the preparation of such certificate, and (iii) and any restrictions on\naccess to the Partnership's and its Affiliates' and subdistributors' books,\nrecords and data which the accountant deems to be a restriction of scope with\nrespect to its engagement.\n\n\nK.       SUBDISTRIBUTION AND ASSIGNMENT\n\n         The Partnership may not assign or otherwise Transfer any of its rights\nto or under this Agreement or enter into any subdistributorships with respect to\nany Distribution Compound or any Distribution Product, except as specifically\npermitted by Section 3.6A of the Master Restructuring Agreement and Section\n3.2(b)(20) and clause (iii) of Section 3.2(b)(6) of the Partnership Agreement.\nAny assignment or Transfer or subdistributorship or purported assignment,\nTransfer or subdistributorship not in strict compliance with Section 3.6A of the\nMaster Restructuring Agreement and Section 3.2(b)(20) and clause (iii) of\nSection 3.2(b)(6) of the Partnership Agreement shall be void. Any\nsubdistributorship granted by the Partnership shall be subject to, subordinate\nto and limited by the rights of the Partnership to this Agreement. The\nPartnership shall require any assignee or transferee of any of the Partnership's\nrights under this Agreement and any subdistributor appointed hereunder to enter\ninto an undertaking pursuant to which provisions in the same form as those\ncontained in Section N hereof shall apply directly between such assignee,\ntransferee or subdistributor and KBI-E.\n\n\n                                       25\n   28\n         Notwithstanding the foregoing, in the event of the exercise of an\nAssignment Right or the occurrence of a Required Sale (each as defined in the\nKBI-E Asset Option Agreement), as of the Assignment Date (as defined in the\nKBI-E Asset Option Agreement) KBI-E shall assign to KB or a Person designated by\nKB all of KBI-E's rights and delegate all of KBI-E's obligations under this\nAgreement with respect to all Products (other than Products containing\nomeprazole or perprazole); provided, however, that KB or its designee shall\nexpressly assume in writing the due and punctual performance of all obligations\nwhich are so assigned or delegated; provided, further, that as a condition to\nthe effectiveness of such assignment, KBI-E shall be released from such\nobligations, except that KBI-E shall not be released from any obligations\narising out of any breach of this Agreement by KBI-E or its Affiliates or\nsubcontractors prior to such assignment.\n\n\nL.       [OMITTED]\n\n\nM.       TERM AND TERMINATION\n\n         1. This Agreement shall be co-extensive in duration to the Amended and\nRestated KBI License, and shall automatically terminate upon any termination of\nthe Amended and Restated KBI License, for any reason; provided, however, that\nupon any termination of the license or option for any Compound subject to the\nAmended and Restated KBI License, this Agreement shall terminate only to the\nextent of such termination of the Amended and Restated KBI License.\n\n         2. If this Agreement shall terminate with respect to any Compound or\nDistribution Product as provided in Section M.1 hereof, the Partnership shall as\npromptly as practicable following the date of such termination transfer to KB\nthe items specified in Section 13.3 of the Amended and Restated KBI License.\n\n\nN.       CONFIDENTIALITY AND PERMITTED DISCLOSURE EXCEPTIONS\n\n         Subject to the provisions of Section 9.2 of the Amended and Restated\nKBI License, each party shall maintain in strict confidence all Confidential\nInformation pursuant to and in accordance with Sections 4.1 and 4.2 of the\nMaster Restructuring Agreement; provided, however, that (i) the Partnership may\ndisclose such information to any governmental agency or authority to the extent\nnecessary to obtain the approval of any agency or authority to make, have made,\nuse or sell any Distribution Compound and (ii) KBI-E may disclose such\ninformation to any governmental agency or authority to the extent necessary to\nobtain the approval of any agency or authority to make, have made, use and sell\nany Exclusive Second Look Compound or any Non-Exclusive Second Look Product;\nprovided, further, however, to the extent permitted by applicable law, such\ndisclosure shall be made on a confidential and restricted basis.\n\n\nO.       INDEMNIFICATION; DISCLAIMER; LIMITATION ON DAMAGES\n\n         1. The Partnership shall indemnify and hold harmless KBI-E, and each of\nits Affiliates, and each of its, and its Affiliates', respective officers,\ndirectors, employees and agents (each, a \"Partnership Indemnitee\") from and\nagainst any and all losses, damages, liabilities or \n\n\n                                       26\n   29\nexpenses (including reasonable attorney's fees and other costs of defense)\n(collectively, \"Losses\") in connection with any and all actions, suits, claims\nor demands (collectively, \"Claims\") that may be brought or instituted against\nany Partnership Indemnitee (i) based upon or arising out of any breach of this\nAgreement by the Partnership or (ii) by any Non-Affiliate of the parties based\non or arising out of (A) the clinical testing or development of any Distribution\nCompound or any Distribution Product by the Partnership or any of its\nAffiliates, (B) the promotion, marketing, sale or distribution, labeling,\ntesting, storage, handling or delivery of any Distribution Product by the\nPartnership or any of its Affiliates, (C) any implied or express claims of\nefficacy or safety of any Distribution Compound or Distribution Product by the\nPartnership or any of its Affiliates, (D) the failure to provide adequate\ndisclosure of contraindications, warnings, precautions and adverse reactions in\nDistribution Product packaging, labels or related physician circulars by the\nPartnership or any of its Affiliates, (E) the training or improper training of\nphysicians in the use of any Distribution Product, (F) the activities of the\nPartnership under this Agreement including without limitation any product\nliability or similar claim by the Partnership or any of its Affiliates or (G)\nany other liability arising out of the business of the Partnership; provided,\nhowever, that the Partnership shall not be obligated to indemnify and hold\nharmless KBI-E or any of its Affiliates or any officer, director, employee or\nagent of KBI-E or any of its Affiliates from any Losses in connection with any\nClaim based on or arising out of any event or circumstance with respect to which\nKBI-E or any of its Affiliates is obligated to indemnify and hold harmless the\nPartnership pursuant to Section O.2 or any other agreement.\n\n         2. KBI-E shall indemnify and hold harmless the Partnership, and each of\nits Subsidiaries, and each of its, and its Subsidiaries' respective partners,\nofficers, directors, employees and agents (each, a \"KBI-E Indemnitee\") from and\nagainst any and all Losses in connection with any and all Claims that may be\nbrought or instituted against any KBI-E Indemnitee (i) based upon or arising out\nof any breach of this Agreement by KBI-E or (ii) by any Non-Affiliate of the\nparties based on or arising out of (A) the clinical testing or development by\nKBI-E or any of its Affiliates, distributors or licensees of any Compound as to\nwhich the rights of the Partnership hereunder have terminated or become\nnon-exclusive or any product containing such Compound, (B) the promotion,\nmarketing, sale or distribution, labeling, testing, storage, handling or\ndelivery of any such Compound or product by KBI-E or any of its Affiliates,\ndistributors or licensees, (C) any implied or express claims of efficacy or\nsafety of any such Compound or product by KBI-E or any of its Affiliates,\ndistributors or licensees, (D) the failure to provide adequate disclosure of\ncontraindications, warnings, precautions and adverse reactions in the packaging,\nlabels or related physician circulars relating to such product by KBI-E or any\nof its Affiliates, distributors or licensees, (E) the training or improper\ntraining of physicians in the use of any such product, (F) the activities of\nKBI-E under this Agreement, including without limitation any product liability\nor similar claim by KBI-E or any of its Affiliates, distributors or licensees or\n(G) any other liability arising out of the business of KBI-E; provided, however,\nthat KBI-E shall not be obligated to indemnify and hold harmless the Partnership\nor any of its Affiliates or any officer, director, employee or agent of the\nPartnership or any of its Affiliates from any Losses in connection with any\nClaim based on or arising out of any event or circumstance with respect to which\nthe Partnership or any of its Affiliates is obligated to indemnify and hold\nharmless KBI-E pursuant to Section O.1 or any other agreement.\n\n\n                                       27\n   30\n         3. As promptly as practicable after any indemnitee referred to in\nSection O.1 or O.2 obtains knowledge of any action, suit, claim or demand as to\nwhich it will or may be entitled to indemnity under Section O.1 or O.2, such\nindemnitee shall give notice to the indemnifying party. If such matter involves\nan action, suit, claim or demand of a third party, the indemnifying party shall\nbe entitled to assume control of the defense or settlement of such action, suit,\nclaim or demand; provided, however, that (i) the indemnitee shall be entitled to\nparticipate in the defense of such matter and to employ counsel of its own\nchoosing and at its own expense to assist in the handling of such matter, and\n(ii) the indemnifying party shall obtain the prior written approval of the\nindemnitee, which approval shall not be unreasonably withheld or delayed, before\nentering into any settlement of such matter or ceasing to defend against such\nmatter.\n\n         4. THE PARTIES ACKNOWLEDGE THAT KBI-E MAKES NO REPRESENTATION OR\nWARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WRITTEN OR ORAL, NOR SHALL KBI-E (OR\nANY OF ITS AFFILIATES) HAVE ANY LIABILITY OF ANY NATURE, WITH REGARD TO THE\nVALUE, ADEQUACY, FREEDOM FROM FAULT OR INFRINGEMENT, QUALITY, EFFICIENCY,\nSUITABILITY, CHARACTERISTICS OR USEFULNESS OF (x) ANY MANUFACTURING PROCESSES,\nPRODUCTION METHODS, MANUFACTURING PATENTS, MANUFACTURING DATA, MANUFACTURING\nINFORMATION OR MANUFACTURING KNOW-HOW (INCLUDING, WITHOUT LIMITATION, ANY OF\nKB'S MANUFACTURING PROCESSES OR MANUFACTURING TECHNICAL INFORMATION) OR (y) ANY\nDISTRIBUTION COMPOUNDS OR ANY DISTRIBUTION PRODUCTS MANUFACTURED, USED OR SOLD\nPURSUANT TO THIS AGREEMENT OR THE KBI SUPPLY AGREEMENT OR (z) ANY LICENSED\nPATENTS, TECHNICAL INFORMATION OR OTHER INFORMATION, DATA OR KNOW-HOW RELATING\nIN ANY WAY TO ANY DISTRIBUTION COMPOUND, INCLUDING, WITHOUT LIMITATION: (i) ANY\nIMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE; (ii)\nANY IMPLIED WARRANTIES ARISING FROM COURSE OF PERFORMANCE, COURSE OF DEALING OR\nUSAGE IN THE TRADE; (iii) ANY WARRANTY OF DESCRIPTION OR OTHERWISE CREATED BY\nANY AFFIRMATION OF FACT OR PROMISE OR SAMPLE OR MODEL; OR (iv) ANY CLAIMS BASED\nON ALLEGATIONS OF INFRINGEMENT OR UNFAIR COMPETITION WITH RESPECT TO ANY PRODUCT\nOR ANY SUCH PROCESSES, PRODUCTION METHODS, PATENTS, DATA, INFORMATION OR\nKNOW-HOW; AND ALL SUCH REPRESENTATIONS, WARRANTIES AND LIABILITIES, WHETHER IN\nCONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARE HEREBY\nDISCLAIMED BY KBI AND BY IT ON BEHALF OF ITS AFFILIATES; PROVIDED, HOWEVER, THAT\nNOTHING CONTAINED IN THIS SECTION SHALL BE DEEMED A WAIVER OF, OR BE DEEMED TO\nLIMIT, THE OBLIGATIONS OF ANY PARTY HEREUNDER.\n\n         5. THE PARTIES ACKNOWLEDGE THAT THE PARTNERSHIP MAKES NO REPRESENTATION\nOR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING, WITHOUT\nLIMITATION, ANY REPRESENTATION OR WARRANTY WITH RESPECT TO THE VALUE, ADEQUACY,\nFREEDOM FROM FAULT \n\n\n                                       28\n   31\nOF, OR THE QUALITY, EFFICIENCY, SUITABILITY, CHARACTERISTICS OR USEFULNESS OF,\nOR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF, ANY LICENSED\nCOMPOUND, OR OF ANY LICENSED PATENT, TECHNICAL INFORMATION OR OTHER INFORMATION,\nDATA OR KNOW-HOW RELATING IN ANY WAY TO ANY LICENSED COMPOUND AS TO WHICH THE\nPARTNERSHIP'S RIGHTS TERMINATE OR BECOME NON-EXCLUSIVE PURSUANT TO SECTION D.\n\n         6. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR SPECIAL, INDIRECT,\nINCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING UNDER OR IN CONNECTION WITH THIS\nAGREEMENT, THE KBI-E ASSIGNMENT OR THE AMENDED AND RESTATED KBI LICENSE, OR THE\nPERFORMANCE OF, OR FAILURE TO PERFORM, ANY OBLIGATIONS HEREUNDER OR THEREUNDER,\nWHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE;\nPROVIDED, HOWEVER, THAT THE FOREGOING SHALL NOT APPLY IN THE CASE OF WILLFUL\nMISCONDUCT OR GROSS NEGLIGENCE; PROVIDED, FURTHER, THAT THE PARTIES AGREE THAT\nCONSEQUENTIAL DAMAGES SHALL NOT INCLUDE ANY LOSS INCURRED BY KBI-E ARISING OUT\nOF THE AMENDED AND RESTATED KBI LICENSE AS A RESULT OF ANY BREACH OF THIS\nAGREEMENT BY THE PARTNERSHIP OR ANY LOSS INCURRED BY THE PARTNERSHIP IN THE\nEVENT (i) OF A BANKRUPTCY (AS DEFINED IN THE MASTER RESTRUCTURING AGREEMENT) OF\nKBI-E THAT IS CAUSED PRIMARILY BY THE BREACH BY KBI-E OR KBI OF THE COVENANTS\nSET FORTH IN SECTION 3.12 OF THE MASTER RESTRUCTURING AGREEMENT AND (ii) THE\nREJECTION OF THIS AGREEMENT BY THE TRUSTEE IN BANKRUPTCY OR\nDEBTOR-IN-POSSESSION.\n\n         7. In no event shall the Partnership be liable to KBI-E for damages\nwith respect to any Licensed Compound for breach of Section 4.1(b) of the\nAmended and Restated KBI License for any period after the Partnership has\ndelivered a Discontinuation Notice pursuant to Section D.1 or the Partnership's\nrights in connection with such Licensed Compound and the Distribution Products\ncontaining such Licensed Compound have terminated and reverted to KBI-E pursuant\nto Section D.2.\n\n\nP.       [OMITTED]\n\n\nQ.       ARBITRATION\n\n         Subject to Section 9.4 of the Master Restructuring Agreement, any\ndispute, controversy or claim between KBI-E and the Partnership arising out of\nor related to this Agreement, or the interpretation or breach hereof, shall be\nsettled by binding arbitration pursuant to the principles and procedures set\nforth in Article 9 of the Master Restructuring Agreement.\n\n\n                                       29\n   32\nR.       MISCELLANEOUS\n\n         1. The Partnership acknowledges and agrees that the provisions of\nSection 10.2 and Article XII of the Amended and Restated KBI License shall apply\ndirectly between KB and the Partnership as if the Partnership were the Licensee\nor a Party thereto.\n\n         2. This Agreement shall inure to the benefit of and be binding upon the\nparties and their respective successors and permitted assigns. This Agreement\nmay be assigned only (i) as permitted by Section K and (ii) as required pursuant\nto the KBI-E Asset Option.\n\n         3. This Agreement shall be construed and governed in accordance with\nthe laws of the State of New York without regard to any choice of law rules\nother than Section 5-1401 of the New York General Obligations Law.\n\n         4. Any notice, request or other communication under or with respect to\nthis Agreement shall be in writing and shall be deemed to have been duly given\nif delivered personally, sent by telecopy transmission with confirmation of\nreceipt, or sent by internationally recognized overnight courier service to\neither Party at its address or telecopier number set forth below:\n\n            If to KBI-E, to:           Astra Merck Enterprises, Inc.\n                                       c\/o Merck &amp; Co., Inc.\n                                       One Merck Drive\n                                       P.O. Box 100\n                                       Whitehouse Station, New Jersey 08889-0100\n                                       USA\n                                       Attention:  Corporate Secretary\n                                       Telecopier: 908-735-1246\n\n            with a copy to:            Merck &amp; Co., Inc.\n                                       P.O. Box 100\n                                       One Merck Drive\n                                       Whitehouse Station, New Jersey 08889-0100\n                                       USA\n                                       Attention:  General Counsel\n                                       Telecopier: 908-735-1244\n\n\n            If to the Partnership, to: Astra Pharmaceuticals, L.P.\n                                       725 Chesterbrook Boulevard\n                                       Wayne, Pennsylvania  19087-5677\n                                       Attention:  General Counsel\n                                       Telecopier: 610-889-1280\n\n\n                                       30\n   33\n            with copies to:            Astra AB\n                                       S-151\n                                       85 Sodertalje, Sweden\n                                       Attention:  General Counsel\n                                       Telecopier: 011-46-8-553-288-12\n\n                                       Winthrop, Stimson, Putnam &amp; Roberts\n                                       One Battery Park Plaza\n                                       New York, New York 10004\n                                       Attention:  Frode Jensen\n                                       Telecopier: 212-858-1500\n\n; provided, however, that any Dispute Notice, Rejection Notice, Discontinuation\nNotice or Non-Compliance Notice shall be sent by internationally recognized\novernight courier service. Either party by written notice to the other in\naccordance with the above may change the address or telecopier number to which\nsuch notices, requests or other communications to it shall be directed.\n\n         5. This Agreement may be amended, modified or supplemented only by a\nwritten instrument duly executed by each party, and may be waived only by a\nwritten instrument duly executed by the party to be bound. Notwithstanding\nanything to the contrary contained herein or therein no party to this Agreement\nshall have the right to unilaterally terminate this Agreement because of any\nbreach or breaches, material, fundamental or otherwise, of this Agreement by any\nother party hereto.\n\n         6. No omission or delay on the part of either party in requiring the\ndue and punctual fulfillment by the other party of any of its obligations\nhereunder shall constitute a waiver by the omitting or delaying party of any of\nits rights to require such due and punctual fulfillment of any obligation\nhereunder, whether similar or otherwise, or a waiver of any remedy it may have\nhereunder or otherwise.\n\n         7. No party shall be responsible or liable to the other party, nor\nshall the Partnership's rights with respect to any Distribution Compound and any\nDistribution Product containing a Distribution Compound terminate and revert to\nKBI-E pursuant to Section D, for any failure or inability to perform any of such\nparty's covenants or obligations under this Agreement, or, in the case of the\nPartnership, for neither conducting an Active Development Program for a\nDistribution Compound or a Competing Compound nor Actively Marketing any\nDistribution Product containing such Distribution Compound or any product\ncontaining a Competing Compound, if such failure or inability results from\nevents or circumstances reasonably beyond the control of such party\n(collectively, \"Events of Force Majeure\"). Events of Force Majeure shall\ninclude, without limitation, any order, decree, law or regulation of any nature\nwhatsoever of any court or governmental authority; war (whether or not\ndeclared); embargo; strike, lockout or other labor difficulty; riot; epidemic;\ndisease; explosion; unavoidable accident; act of God; civil commotion; fire;\nearthquake; storm; flood; failure of public utilities or common carriers;\nunavailability of, or material reduction in the supply of, raw materials or\n\n\n                                       31\n   34\nintermediates, labor, fuel, electricity, water or transport; and any other\ncircumstances whatsoever whether similar to the above causes or not; provided,\nhowever, that the foregoing shall not include any event or circumstance which\nprevents a party from obtaining the funds sufficient to make any payment\nrequired to be made by it pursuant to this Agreement, but shall include any such\nevent or circumstance which prevents a party from transferring such funds to the\nother party to effect such payment. The party failing or unable to perform as a\nresult of an Event of Force Majeure shall promptly notify the other party of\nsuch Event of Force Majeure and shall take all action as is reasonably possible\nto remove such Event of Force Majeure; provided, however, that nothing contained\nherein shall require the settlement of any strike, lockout or other labor\ndifficulty, or of any investigation or proceeding by any governmental authority\nor of any litigation, by a party on terms unsatisfactory to it.\n\n         8. Reasonable Efforts. Wherever it is provided in this Agreement that a\nparty shall use reasonable efforts for any purpose, such party shall be required\nonly to use such efforts, if any, as are commercially reasonable in the\ncircumstances and as are consistent with the policies and practices utilized by\nit and their Affiliates in conducting their own businesses. Without limiting any\nother provisions hereof, each party will perform its respective obligations\nunder this Agreement in a manner reasonably consistent with that employed by\nsuch party in connection with its other pharmaceutical products of comparable\ncommercial potential. The parties acknowledge and agree that neither the\ndefinition of \"reasonable efforts\" contained in this Section R.8 nor the\nsatisfaction of the standards set forth in this Section R.8 shall have any\nimport or effect with respect to (i) the determination of whether the\nPartnership has used reasonable efforts with respect to the marketing,\ndistribution and sale of Distribution Compounds as required by Section B.1(d)\nfollowing a Trigger Event or (ii) the use of reasonable efforts for purposes of\nthe definition of \"Actively Marketing\" or \"Active Development Program.\"\n\n\n                                       32\n   35\n         IN WITNESS WHEREOF, the parties hereto have executed this Agreement as\nof the day and year first above written.\n\n                                       ASTRA MERCK ENTERPRISES INC.\n\n\n\n                                       By: \/s\/ Peter E. Nugent\n                                           -------------------------------\n                                           Name: Peter E. Nugent\n                                           Title President\n\n\n\n\n                                       ASTRA PHARMACEUTICALS, L.P.\n\n                                       By: KB USA, L.P., General Partner\n\n                                       By: ASTRA AB, General Partner\n                                               (publ)\n\n\n\n                                       By: \/s\/ Christian Onfelt\n                                           -------------------------------\n                                           Name:  Christian Onfelt\n                                           Title: Authorized Signatory\n   36\n\n\n                                                                       Exhibit B\n\n\n\n                          Form of Trademark Assignment\n\n                  This ASSIGNMENT is made on ___________, 19__, by ____________,\na [corporation\/limited partnership] organized and existing under the laws of\n[jurisdiction] (\"Assignor\"), whose address is ________________, to\n______________, a [corporation\/limited partnership] organized and existing under\nthe laws of [jurisdiction] (\"Assignee\"), whose address is [U.S. address].\n\n                  WHEREAS, Assignor has adopted, used and is using the following\nmarks which are registered in the United States Patent and Trademark Office:\n\n              Registration No.                   Date of Registration\n\n\n\n\n(collectively, the \"Assigned Marks\"); and\n\n                  WHEREAS, Assignee desires to acquire the Assigned Marks\npursuant to [name of agreement];\n\n                  NOW, THEREFORE, for good and valuable consideration, receipt\nof which is hereby acknowledged, Assignor does hereby assign unto Assignee all\nright, title, interest and goodwill in and to such Assigned Marks, together with\nthe above-identified registrations of the Assigned Marks and applications to\nregister the same, any renewals that may be granted thereon, and past common law\ncauses of action.\n\n                                             [Assignor]\n\n\n                                             By:_____________________________\n                                                Name:\n                                                Title:\n\nState of ____________      )\n                           )  ss:\nCounty of __________       )\n\n\n         On this _____ day of __________, before me appeared ____________, the\nperson who signed this instrument, who acknowledged that he\/she signed it on\nbehalf of Assignor with authority to do so.\n\n\n\n<\/pre>\n","protected":false},"template":"","meta":{"_acf_changed":false,"_stopmodifiedupdate":true,"_modified_date":"","_cloudinary_featured_overwrite":false},"corporate_contracts_companies":[6779,8190],"corporate_contracts_industries":[9407],"corporate_contracts_types":[9613,9619],"class_list":["post-42237","corporate_contracts","type-corporate_contracts","status-publish","hentry","corporate_contracts_companies-astrazeneca-plc","corporate_contracts_companies-merck---co","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\/42237","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=42237"}],"wp:term":[{"taxonomy":"corporate_contracts_companies","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_companies?post=42237"},{"taxonomy":"corporate_contracts_industries","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_industries?post=42237"},{"taxonomy":"corporate_contracts_types","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_types?post=42237"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}