{"id":42021,"date":"2015-09-17T11:25:58","date_gmt":"2015-09-17T16:25:58","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-legal\/contracts\/uncategorized\/agreement-for-supply-of-material-connaught-laboratories-ltd.html"},"modified":"2015-09-17T11:25:58","modified_gmt":"2015-09-17T16:25:58","slug":"agreement-for-supply-of-material-connaught-laboratories-ltd","status":"publish","type":"corporate_contracts","link":"https:\/\/corporate.findlaw.com\/contracts\/operations\/agreement-for-supply-of-material-connaught-laboratories-ltd.html","title":{"rendered":"Agreement for Supply of Material &#8211; Connaught Laboratories Ltd., ImClone Systems Inc., and Merck KGaA"},"content":{"rendered":"<pre>                        AGREEMENT FOR SUPPLY OF MATERIAL\n\nThis AGREEMENT FOR SUPPLY OF MATERIAL (the 'Agreement'), among\n\n         Connaught  Laboratories  Limited,  a Pasteur Merieux Connaught company,\n         incorporated  under the laws of Ontario,  Canada  with  offices at 1755\n         Steeles Avenue West, Toronto, Ontario, Canada M2R 3T4, ('PMC')\n\nand\n\n         ImClone Systems  Incorporated,  a company  existing and organized under\n         the laws of Delaware,  USA with offices at 180 Varick Street, New York,\n         NY, USA 10014, ('ImClone')\n\nand\n\n         Merck  KGaA,  a company  incorporated  under the laws of  Germany  with\n         offices at Frankfurter Strasse 250, 64271 Darmstadt, Germany, ('Merck')\n\nis  effective  as of this 1st day of  January,  1997  ('Effective  Date'),  with\nrespect to the following facts and circumstances:\n\n         WHEREAS PMC has a proprietary  interest in and manufactures and sells a\nproduct known as BCG vaccine,  consisting of BCG in vaccine formulation with its\naccompanying  diluent  in a  10-dose  vial  presentation  (hereinafter  the 'BCG\nMaterial'); and\n\n         WHEREAS  ImClone and Merck  severally have a proprietary  interest in a\nmonoclonal  anti-idiotypic  antibody  known  as BEC2  (hereinafter  'BEC2')  and\njointly  are  performing  clinical  and  pre-clinical  research  relating to the\ntreatment and\/or  prophylaxis of certain human cancers by  administration of the\nBEC2; and\n\n         WHEREAS ImClone and Merck intend to administer a combination therapy of\nBEC2 and BCG  Material  to  certain  patients  with  small  cell lung  carcinoma\n('SCLC') in a multi-national Phase III clinical trial being conducted in Europe,\nAustralia and the United States  (hereinafter the 'SILVA Trial') pursuant to the\nprotocol(s)  and  investigators'  brochure(s)  (hereinafter  the 'Clinical Trial\nProtocol') attached hereto as Exhibit 'A'; and\n\n         WHEREAS, ImClone and Merck may administer a combination therapy of BEC2\nand BCG Material to other patients in such  additional  clinical trials that are\nnecessary or advisable in the sole discretion of ImClone and Merck in connection\nwith or in furtherance of the SILVA Trial (the  'Additional  Clinical  Trials');\nand\n\n*** Confidential Treatment Requested\n\n\n                                      -2-\n\n\n         WHEREAS  ImClone and Merck are  interested  in securing a supply of the\nBCG  Material  to be  administered  with  BEC2 in the  SILVA  Trial and any such\nAdditional  Clinical  Trials,  and PMC is willing to supply the BCG  Material to\nImClone and Merck on the terms set forth herein.\n\n         NOW THEREFORE, in consideration of the foregoing and for other good and\nvaluable  consideration,   the  receipt  and  sufficiency  of  which  is  hereby\nacknowledged, the parties hereby agree as follows:\n\n1.       Trials to be Conducted; Status of Recipient\n\n         ImClone and Merck are  conducting  the SILVA  Trial and any  Additional\nClinical Trials together, and will receive supplies of the BCG Material together\nor  independently  for the sole  purpose of  conducting  the SILVA Trial and the\nAdditional  Clinical Trials (the SILVA Trial and the Additional  Clinical Trials\nare collectively referred to herein as the 'Clinical Trials'). ImClone and Merck\nshall be referred to for the purposes  herein as the 'Recipient' and the term so\nused shall mean ImClone and Merck together or either of them.  ImClone and Merck\nshall be jointly and severally liable in respect of the obligations set forth in\nthis Agreement, except as specifically noted hereinbelow.\n\n2.       Supply and Acceptance of Delivery\n\n         2(a).    Quantities of the BCG Material\n\n         Subject to the terms of this Agreement and during the [ *** ] following\nthe Effective Date  (hereinafter the 'Supply  Period'),  PMC shall supply to the\nRecipient, and the Recipient shall accept delivery from PMC of, the BCG Material\nfor use in and  during  the  Clinical  Trials  on the  following  dates,  in the\nfollowing quantities and with the following expiry dating:\n\n                           (i)      [ *** ]\n\n                           (ii)     [ *** ]\n\n                           (iii)    [ *** ]\n\n                           (iv)     [ *** ]\n\n                           (A)      [ *** ]\n\n                           (B)      [ *** ]\n\n                           (C)      [ *** ]\n\n                           (D)      [ *** ]\n\n*** Confidential Treatment Requested\n\n\n                                      -3-\n\n\n           [ *** ]\n\n         2(b).    Cost of Supply\n\n                  [ ***]\n\n         2(c).    Delivery;  Risk of Loss\n\n                  At  Recipient's  cost,  PMC shall  deliver or arrange  for the\ndelivery  of the  BCG  Material  to  Recipient,  FOB at a  point  or  points  of\ndestination  selected  by  Recipient,  to a  reputable  carrier.  Prior  to  any\ndelivery, Recipient shall forward import permits or other documents, as required\nfor shipment, to PMC to the attention of Ms. Joy Rennick, Logistics Coordinator,\n(facsimile:  416-667-2275).  Upon delivery of the BCG Material,  Recipient shall\nassume  all  risk of loss or  damage  for the BCG  Material  so  delivered.  All\ntemperature  monitoring  devices  shall be returned by  Recipient  to PMC to the\nattention of Ms. Rennick.\n\n         2(d).    Technical Services Assistance\n\n                  Upon the reasonable request by Recipient, and in consideration\nof payment by ImClone of PMC's costs and services  fees at a rate of [ *** ] for\nregulatory\/logistics  personnel,  PMC shall make,  and has made,  available  its\nclinical\/medical  and  regulatory\/logistics  personnel  (at their usual place of\nemployment or by telephone) to provide reasonable levels of technical assistance\nto the Recipient in connection with PMC's Regulatory Manufacturing Documentation\nfor the BCG Material or in connection  with the Recipient's  Regulatory  Filings\nrequired for the Clinical  Trials.  ImClone shall pay PMC, by no later than July\n15, 1998, the amount of [ *** ], representing the sum of:\n\n                  (i)      [   ***  ]\n\n                  (ii)     [   ***  ]\n\n                  (iii)    [   ***  ]\n\n                  (iv)     [   ***  ]\n\n                  ImClone  agrees  to pay for  any  further  technical  services\nprovided by PMC and tests  conducted by or on behalf of PMC, in connection  with\nthis Agreement or the Clinical Trials,  at the hourly rates agreed to herein and\nthe costs to PMC of any such tests.  The  parties  agree that the  currency  for\npayment shall be Canadian dollars.\n\n         2(e).    Negotiations for Future Commercial Supply\n\n                  In the event that the  Recipient  wishes to seek  registration\nfor the combination therapy of BEC2 and BCG Material, Recipient shall notify PMC\nin writing.  PMC and the  Recipient  agree that  within  sixty (60) days of said\nwritten notice from the Recipient, the parties\n\n*** Confidential Treatment Requested\n\n\n                                      -4-\n\n\nshall  initiate  good faith  negotiations  toward the  securing of a  commercial\nsupply  agreement  for the  purchase by  Recipient  of BCG  Material  with terms\nsatisfactory  to both parties,  including  without  limitation,  purchase price.\nFailure to reach such  agreement  during the Term within  twelve  months (12) of\ninitiation of negotiations, or as of such earlier time when it is clear that the\nparties cannot reach such  agreement,  shall be grounds for  termination of this\nAgreement by either PMC or  Recipient,  upon thirty (30) days written  notice to\nthe other.\n\n3.       Preparation and Conduct of the SILVA Trial\n\n         3(a).    Regulatory Filings;  Manufacturing Regulatory Documentation\n\n                  At  Recipient's  sole  cost,  Recipient  shall file and be the\nowner of record for all Regulatory  Filings developed by the Recipient  relating\nto  the  Clinical  Trials.  'Regulatory  Filing'  shall  mean  a  filing  with a\nregulatory agency,  for example,  the US Food and Drug  Administration  ('FDA'),\nthat concerns the Clinical  Trials.  Recipient  owns and shall retain all right,\ntitle and interest in and to BEC2 (and any improvements, progeny, derivatives or\nrelated  materials  thereof) and the  Regulatory  Filings.  PMC shall permit the\nRecipient to cross-reference  PMC's Product License  Application  Supplement and\nDrug  Master  File for BCG  Material  and\/or  otherwise  excerpt  portions of or\ndescribe PMC's Product  License  Application  Supplement and Drug Master File in\nthe Regulatory  Filings,  to enable the Recipient to complete Regulatory Filings\nrequired for the Clinical  Trials.  Notwithstanding  the foregoing,  the parties\nagree  that  despite   Recipient's   cross-referencing   PMC's  Product  License\nApplication  Supplement and Drug Master File for BCG Material  and\/or  otherwise\nexcerpting   portions  of  or  describing  PMC's  Product  License   Application\nSupplement and Drug Master File in the Regulatory  Filings,  PMC owns, and shall\nretain  all  right,  title  and  interest  in and to the BCG  Material  (and any\nimprovements,  progeny,  derivatives  or  related  materials  thereof)  and  the\nManufacturing Regulatory Documentation. 'Manufacturing Regulatory Documentation'\nshall  mean a  Product  License  Application,  Drug  Master  File  or any  other\nregulatory filing or documentation owned, developed, submitted or prepared by or\non behalf of PMC and filed with appropriate regulatory authorities that contains\ninformation   concerning  the  BCG  Material,   including  but  not  limited  to\ninformation  concerning  the BCG Material  contained in the  Regulatory  Filings\nwhich is excerpted from or describes PMC's Product  License  Application or Drug\nMaster File or other regulatory filing by or on behalf of PMC which concerns the\nBCG Material,  which  information,  Recipient  agrees and  undertakes,  shall be\ndeemed and  treated as  Confidential  Information.  All  non-public  information\nprovided  by one  party to the other in  preparing  Regulatory  Filings  and the\nManufacturing  Regulatory  Documentation  shall  be  deemed  to be  Confidential\nInformation of the disclosing party for the purposes of this Agreement.\n\n         3(b).    Protocols for Clinical Trials; Results\n\n                  At Recipient's  sole cost,  Recipient shall be responsible for\nthe design, implementation, and evaluation of any human clinical studies used to\nobtain  clinical  data for use in preparing  Regulatory  Filings  related to the\nClinical Trials.  Recipient shall conduct the Clinical Trials in compliance with\ncurrent Good Clinical Practices ('cGCP') pursuant to FDA regulations. Recipient,\nat its sole cost, shall provide PMC with a complete copy of the protocols\n\n*** Confidential Treatment Requested\n\n\n                                      -5-\n\n\nand  investigators'  brochures for the Clinical Trials, as well as copies of all\nreports,  abstracts and publications (subject to Section 5(c) herein) concerning\nthe data and results of the Clinical  Trials.  All right,  title and interest in\nand to the data and  results of the  Clinical  Trials  shall vest in  Recipient;\nprovided that any information relating to the BCG Material shall remain the sole\nproperty of PMC.\n\n         3(c).    Adverse Reaction Reporting\n\n                  Recipient  shall  promptly  notify PMC of any serious  adverse\nreactions which result from the conduct of the Clinical Trials on the same basis\nthat such  reporting is made to the  appropriate  regulatory  authorities.  Such\nnotices  shall  be sent  by  Recipient  to PMC to the  attention  of Mrs.  Doris\nRudert-Dolby, Supervisor, Regulatory Affairs (facsimile: 416-667-2912). For this\npurpose,  it is  understood  that an adverse  reaction  is subject to  expedited\nreporting  to  appropriate  regulatory  authorities  if  such  adverse  reaction\nconstitutes an  'unexpected  adverse  reaction' and if the minimum  criteria for\nexpedited  reporting  are met (as such  criteria  are set forth in the ICH Topic\nE2A:  Clinical  Safety Data Management - Definitions and Standards for Expedited\nReporting,  June 1, 1995). An 'unexpected adverse reaction' is one the nature or\nseverity of which is not consistent  with the information in the relevant source\ndocument (i.e., the most recent version of the investigators'  brochure).  It is\nfurther  understood that  'SCLC-related  Deaths' are the end-points of the SILVA\nTrial and are, therefore, not subject to expedited reporting.\n\n         3(d). PMC's Notice in Connection With Actions by Regulatory Authorities\n\n                  PMC shall  promptly  notify  Recipient  of any  threatened  or\npending  actions by regulatory  authorities  which may reasonably be believed to\naffect the safety or efficacy claims of the BCG Material or to affect the supply\ncommitment  contained in this Agreement.  Any form of such notice that is not in\nwriting shall be promptly followed by notice in writing.\n\n         3(e). Recipient's Notice in Connection With Actions by Regulatory\n                 Authorities\n\n                  Recipient  shall  promptly  notify  PMC of any  threatened  or\npending  actions by regulatory  authorities  which may reasonably be believed to\naffect the safety or efficacy  claims of BEC2 or of the  combination  therapy of\nBEC2 and BCG Material or to affect the Clinical Trials.  Any form of such notice\nthat is not in writing shall be promptly followed by notice in writing.\n\n         3(f).    Recipient's Provision of Updated Investigators' Brochure\n\n                  For the purpose of keeping  PMC  apprised of the status of the\nClinical  Trials,  Recipient  shall  provide  to  PMC  a  copy  of  all  updated\ninvestigators'  brochures  which  Recipient  is required to file with the FDA or\nother regulatory agency anywhere.\n\n*** Confidential Treatment Requested\n\n\n                                      -6-\n\n\n4.       Availability and Manufacture of BCG Material and of BEC2\n\n         4(a).    BCG Material for Clinical Trials\n\n                  During the Supply Period, PMC shall supply the BCG Material in\nthe quantities and according to the terms set forth in Sections  2(a)(i),  (ii),\n(iii) and (iv); provided, however, that with respect to the quantities and terms\nset forth in  Section  2(a)(iii)  and (iv),  PMC shall only be  required  to use\nreasonable  commercial  efforts to make available to Recipient such BCG Material\nas may be requested for the Additional  Clinical Trials. With respect to the BCG\nMaterial requested pursuant to Sections 2(a)(iii) and 2(a)(iv),  in the event of\nForce Majeure or of supply shortage or production constraint, PMC shall allocate\nthe available  quantities of BCG Material among PMC, its  affiliates,  customers\nand distributors, including Recipient, in a commercially reasonable manner. Each\nlot of BCG Material  released to the Recipient for the Clinical  Trials shall be\nmanufactured in compliance with current Good  Manufacturing  Practices  ('cGMP')\npursuant to FDA  regulations and according to  manufacturing  information in the\nManufacturing Regulatory Documentation.  PMC shall, or shall cause a third party\nto,  perform  quality  control  testing  of the  BCG  Material  released  to the\nRecipient to establish  compliance with any release  specifications  required by\nthe Manufacturing Regulatory Documentation.\n\n         4(b).    BEC2 for Clinical Trials\n\n                  During the Term,  Recipient  shall use  reasonable  commercial\nefforts to have sufficient quantities of BEC2 for use in the Clinical Trials. In\nthe event of Force  Majeure  or of supply  shortage  or  production  constraint,\nRecipient  shall  notify PMC as soon as possible so as to permit PMC to allocate\nthe above-noted quantities of BCG Material among PMC, its affiliates,  customers\nand  distributors  at  PMC's  sole  discretion.  Each  lot of BEC2  released  by\nRecipient for the Clinical  Trials shall be manufactured in compliance with cGMP\npursuant to FDA  regulations and according to  manufacturing  information in the\nRegulatory  Filings.  Recipient  shall, or shall cause a third party to, perform\nquality  control  testing  of BEC2 to  establish  compliance  with  any  release\nspecifications required by the Regulatory Filings.\n\n         4(c).    BCG Material Specifications\n\n                  PMC  shall  provide  BCG  Material  to  the  Recipient  in the\navailable  vialed  formulations  and vial sizes  specified  in the then  current\nManufacturing Regulatory Documentation.  PMC shall have no obligation under this\nAgreement  to develop any other vial sizes or  formulations  of BCG Material for\nthe  Recipient.  PMC shall use  reasonable  commercial  efforts to maintain  the\nintegrity and consistency of all specifications  applicable to BCG. In the event\nthat PMC  deems  it  necessary  to  revise  any  specifications,  procedures  or\nManufacturing  Regulatory  Documentation  applicable to BCG Material,  PMC shall\nprovide  reasonable advance notice of any such revision to the Recipient for the\nsole purpose of permitting  Recipient to revise the Clinical  Trial  Protocol or\nRegulatory  Filings,  as  required.  All  specification  changes  that result in\nprocedures  or  limits  that  exceed  or  differ  from  those  set  forth in the\nManufacturing  Regulatory  Documentation  shall be  submitted  to the FDA before\nbeing implemented to the extent the FDA so requires such submission.\n\n*** Confidential Treatment Requested\n\n\n                                      -7-\n\n\n         4(d).    Documentation\n\n                  Upon  acceptance by Recipient of delivery of the BCG Material,\nPMC shall provide the Recipient  with a  Certificate  of Analysis  applicable to\neach lot of BCG Material delivered to the Recipient.  Complete batch records and\nsufficient  retention  samples for the BCG Material  delivered to the  Recipient\nshall be maintained at PMC for  inspection at any time by the Recipient at PMC's\nplace of business upon reasonable  prior written notice to PMC. Any confidential\nor proprietary information of PMC or of its affiliates contained in such records\nor samples shall be deemed to be Confidential Information of PMC.\n\n         4(e).    PMC Facility Audits\n\n                  Upon reasonable prior written notice to PMC, the Recipient may\n(but shall not be  required  to) have its  representatives,  acting  reasonably,\naudit PMC's production of the BCG Material to be used in the Clinical Trials for\ncompliance  with cGMP;  provided  however that such  representatives  shall have\nfirst  signed  a   confidentiality   agreement  with  PMC.   Recipient  and  its\nrepresentatives shall comply with all applicable health,  safety,  environmental\nand security laws and with PMC's policies and procedures  while present at PMC's\nfacilities.\n\n         4(f).    Recall or Withdrawals\n\n                  In  the  event  that  a  party  is  notified  of a  recall  or\nwithdrawal  of BEC2 or of the BCG  Material in any  country,  or  believes  such\nrecall  or  withdrawal  is  necessary,  it shall  immediately  notify  the other\nparties.  The parties will consult on the necessity of, and appropriate  actions\nand mutually  acceptable  procedures to be taken in connection with, a recall or\nwithdrawal.  If such recall or  withdrawal  is  undertaken,  the  parties  shall\ncooperate in taking all reasonable and appropriate  action necessary to complete\nsuch recall or withdrawal in a timely fashion.\n\n5.       Confidentiality and Disclosure\n\n         5(a).    General Obligations of Confidentiality\n\n                  For a period of ten (10) years  following  any  disclosure  of\nConfidential  Information  hereunder,  the Recipient  and PMC shall  maintain in\nconfidence the respective Confidential Information received or obtained from the\nother,  and  use  such   Confidential   Information   solely  for  the  purposes\ncontemplated  and  permitted  by  this  Agreement.  Each  party  shall  maintain\ncommunications to the other parties in confidence.  Each party acknowledges that\nall Confidential  Information exchanged or developed hereunder shall be owned by\nthe  transferor  and  shall  continue  to be owned by the  transferor  following\ntransfer.  'Confidential  Information'  shall mean any and all  confidential  or\nproprietary  information owned by PMC (or its affiliates) or by the Recipient or\neither of ImClone or Merck (or their  affiliates)  that is provided to the other\nparties.  Confidential  Information  shall not be deemed to include  information\nthat:\n\n*** Confidential Treatment Requested\n\n\n                                      -8-\n\n\n                  (i) is or  becomes  known  publicly  through  no  fault of the\nreceiving party;\n\n                  (ii) is learned  by the  receiving  party  from a third  party\nentitled to disclose it;\n\n                  (iii) is developed by the  receiving  party  independently  of\ninformation obtained from the disclosing party as shown by the receiving party's\nwritten records;\n\n                  (iv) is already  known to the receiving  party before  receipt\nfrom the disclosing party, as shown by prior written records; or\n\n                  (v)  is  released  with  the  prior  written  consent  of  the\ndisclosing party.\n\n         5(b).    Permitted Disclosures\n\n                  Notwithstanding  Section  5(a) hereof,  PMC and the  Recipient\nshall,  upon prior  written  notice to the other  parties and only to the extent\nnecessary,   have  the  right  to  disclose  the  other  parties'   Confidential\nInformation  to regulatory or government  agencies for the purposes of preparing\nor   supplementing   any   Regulatory   Filing   or   Manufacturing   Regulatory\nDocumentation,   as   applicable,   or  of   otherwise   assisting  in  securing\ninstitutional  or government  approval to clinical test the BCG Material,  or as\nrequired  by law  within  each  country  where  the  Clinical  Trials  are being\nconducted.\n\n         5(c).    Publications\n\n                  The parties acknowledge that the data and results arising from\nthe Clinical Trials should be published and presented except to the extent where\nsuch  publication  or  presentation  would be reasonably  expected to materially\ndiminish  the  commercial   value  of  the  BCG  Material,   or  to  affect  the\npatentability  of the BCG  Material  or any  improvements  thereof.  The parties\nfurther acknowledge that the Clinical Trials are multi-centre studies. Recipient\nundertakes and shall ensure that the data and results  arising from the Clinical\nTrials shall not be published or  presented by  Recipient,  by the  coordinating\ninvestigators or by other participating individuals or entities, until such time\nas the  Clinical  Trials are  completed  and the data and results  are  analyzed\nthereafter.  Upon  completion of the SILVA Trial,  Recipient shall ensure that a\ncooperative   clinical   administrative   body,   comprising  the   coordinating\ninvestigators,  shall prepare a report which will include a statistical analysis\nand an appraisal of the final data and results from a medical viewpoint. Interim\npublication  or   presentation   of  the  Clinical  Trials  would  include  only\ndemographic  data,  for  publicity  purposes.   Any  publication,   abstract  or\npresentation,  whether verbal or written,  of such data,  results or report,  or\nexcerpts or interpretations  thereof, shall be submitted by Recipient to PMC for\nreview, pursuant to the following conditions:\n\n                  (i)   Recipient   shall  ensure  that  any   article,   paper,\nmanuscript,  report,  data,  results,  abstract,  poster  or notes  shall not be\npublished  or  presented  until  the  completion  of the  SILVA  Trial and after\nanalysis of the final results of the SILVA Trial;\n\n*** Confidential Treatment Requested\n\n\n                                      -9-\n\n\n                  (ii)  Recipient  shall  ensure  that any such  publication  or\npresentation  acknowledges  the contribution of the parties and their employees,\nrepresentatives or consultants as co-authors or as otherwise appropriate; and\n\n                  (iii) Recipient shall ensure that the publishing party deliver\nto PMC,  at  least  sixty  (60)  days in  advance  of any  such  publication  or\npresentation,  any article, paper, manuscript,  report, data, results, abstract,\nposter or notes  proposed to be published or presented,  in order to permit PMC,\nacting reasonably:\n\n                        (A)   to apply for patents or make such other filings or\n                  registrations as deemed advisable,\n\n                        (B)   to object to any part of such proposed publication\n                  or  presentation  on the  basis  that it  would be  reasonably\n                  expected  to  materially  diminish   the  value  of  the   BCG\n                  Material and information  related thereto,\n\n                        (C)   to require that any  Confidential  Information  be\n                  deleted from any  such proposed  publication  or presentation,\n                  or\n\n                        (D)   to   revise   such   proposed    publication    or\n                  presentation accordingly.\n\nRecipient  undertakes and shall ensure that similar publication and presentation\nprocedures will be established for any Additional Clinical Trials.\n\n         5(d).    Use of Names or Trademarks\n\n                  The parties shall not  originate any press release  concerning\nthe entering into of this  Agreement or the subject  matter  hereof  without the\nprior  written  approval  of the  other  parties,  which  approval  shall not be\nunreasonably  withheld.  The parties shall not have the right to use the name or\nany trade name or trademark of the other parties without prior written approval.\nReference to the existence of this  Agreement may be made in the regular  course\nof business of the parties in informational  disclosures describing the business\nof the parties, upon prior written notice to the other parties.\n\n6.       Warranties and Representations\n\n         6(a). Warranties and Representations of PMC.\n\n                  Subject to Section 7(a),  PMC  represents  and warrants to the\nRecipient that:\n\n                  (i) PMC is a corporation duly organized,  validly existing and\nin good standing and has all necessary corporate power to enter into and perform\nits obligations under this Agreement;\n\n                  (ii) the execution, delivery and performance of this Agreement\nby PMC have been duly authorized and approved by all necessary corporate action,\nand the Agreement is binding\n\n*** Confidential Treatment Requested\n\n\n                                      -10-\n\n\nupon and  enforceable  against  PMC in  accordance  with its terms  (subject  to\nbankruptcy and similar laws affecting the rights of creditors generally);\n\n                  (iii) each lot of the BCG Material  delivered to the Recipient\nfor the Clinical Trials shall be manufactured, tested and released in compliance\nwith cGMP and the applicable Manufacturing Regulatory Documentation; and\n\n                  (iv)  any  documentation  provided  to  the  Recipient  by PMC\nconcerning the BCG Material or Manufacturing  Regulatory  Documentation shall be\naccurate to the best of PMC's knowledge and ability.\n\n         6(b).    Warranties and Representations of the Recipient\n\n                  Recipient  and  each  of  ImClone  and  Merck  represents  and\nwarrants to PMC that:\n\n                  (i) Recipient consist of corporations duly organized,  validly\nexisting and in good  standing and have all necessary  corporate  power to enter\ninto and perform their obligations under this Agreement;\n\n                  (ii) the execution, delivery and performance of this Agreement\nby the  Recipient  have been  duly  authorized  and  approved  by all  necessary\ncorporate action, and the Agreement is binding upon and enforceable  against the\nRecipient in accordance  with its terms  (subject to bankruptcy and similar laws\naffecting the rights of creditors generally);\n\n                  (iii)  Recipient shall use BCG Material in compliance with all\napplicable  laws and  regulations  and  shall  conduct  the  Clinical  Trials in\ncompliance with cGMP and cGCP;\n\n                  (iv) Recipient is not aware of any special or unusual  hazards\nthat would arise as a result of the combination of BEC2 and BCG Material for the\nClinical Trials to be conducted by Recipient;\n\n                  (v)  each  lot of  BEC2  for  the  Clinical  Trials  shall  be\nmanufactured,  tested and released in  compliance  with cGMP and the  applicable\nRegulatory Filings; provided that, in connection with such release only, each of\nImClone and Merck provides such warranty and representation  with respect to the\nterritories in which they  respectively  are  responsible for the conduct of the\nClinical Trials;\n\n                  (vi) any documentation concerning the Clinical Trials, BEC2 or\nRegulatory  Filings shall be accurate to the best of  Recipient's  knowledge and\nability; and\n\n                  (vii) Recipient does not guarantee any particular results from\nthe conduct of the Clinical Trials.\n\n*** Confidential Treatment Requested\n\n\n                                      -11-\n\n\n7.       Limitation of Liability; Indemnification\n\n         7(a).    Limitation of Liability\n\n                  PMC has limited  knowledge or awareness of, and has no control\nover,  the manner in which the Recipient  intends to use the BCG  Material.  PMC\nshall not be liable for any  losses,  damages,  costs or  expenses of any nature\nincurred or suffered by the  Recipient or by a third  party,  arising out of any\ndispute or other claims or proceedings (including,  without limitation,  product\nliability  claims  and  claims by a third  party  alleging  infringement  of its\nintellectual  property  rights  by the  use or sale  of BCG  Material),  made or\nbrought as a result of the Clinical  Trials or against the Recipient,  nor shall\nPMC be  responsible  in any way for dealing  with any such  disputes,  claims or\nproceedings,  except to the extent that any such  dispute,  claim or  proceeding\narises  from (a) a breach  by PMC of any  warranty  set  forth in  Section  6(a)\nhereof, or (b) any failure by PMC to manufacture,  test, document or release the\nBCG Material in compliance with cGMP and the applicable Manufacturing Regulatory\nDocumentation.  PMC shall not be responsible for any interruption in supply that\nis caused by Force  Majeure.  EXCEPT AS SET FORTH IN SECTION  6(a)  HEREOF,  PMC\nMAKES NO  WARRANTIES,  EXPRESS OR IMPLIED,  WRITTEN OR ORAL,  INCLUDING  WITHOUT\nLIMITATION  ANY  WARRANTIES  OF  MERCHANTABILITY,  OF FITNESS  FOR A  PARTICULAR\nPURPOSE OR OF NON-INFRINGEMENT  OF THIRD PARTY PATENTS.  PMC SHALL NOT BE LIABLE\nFOR ANY LOSS, CLAIM, DAMAGE, EXPENSE OR LIABILITY,  OF ANY KIND OR NATURE, WHICH\nMAY ARISE FROM OR IN CONNECTION  WITH THIS AGREEMENT OR WITH THE CLINICAL TRIALS\nOR FROM THE USE,  HANDLING OR STORAGE OF BCG MATERIAL,  BEC2 OR THEIR  ANCILLARY\nMATERIALS BY RECIPIENT OR BY ANY  AFFILIATES,  EMPLOYEES,  AGENTS,  CONTRACTORS,\nINVESTIGATORS OR REPRESENTATIVES OF RECIPIENT.  NO PARTY TO THIS AGREEMENT SHALL\nBE  ENTITLED  TO  RECOVER  FROM  THE  OTHER  PARTIES  ANY  SPECIAL,  INCIDENTAL,\nCONSEQUENTIAL OR PUNITIVE DAMAGES.\n\n         7(b).    Recipient's Right to Indemnification\n\n                  PMC  hereby  agrees to  indemnify,  defend  and hold  harmless\nRecipient and its affiliates, officers, directors, employees and representatives\n(collectively,  the 'Recipient's Indemnitees') from and against any liabilities,\nclaims,  damages,  costs,  expense (including  reasonable  attorneys' fees), and\nactions  (collectively,  'Claims')  arising  out of or  resulting  from  (i) the\nfailure by PMC to  manufacture,  test,  document or release the BCG  Material in\ncompliance with cGMP and the applicable  Manufacturing  Regulatory Documentation\nor (ii) the  breach by PMC or PMC's  Indemnitees  of any of its  obligations  or\nwarranties  hereunder,  except to the extent that any such Claims  arise out of,\nare based upon or result  from the gross  negligence  or willful  misconduct  of\nRecipient or  Recipient's  Indemnitees  or a breach by Recipient or  Recipient's\nIndemnitees of any of Recipient's obligations or warranties under this Agreement\nor under the Clinical  Trial  Protocol or Regulatory  Filings.  Recipient  shall\npromptly notify PMC of any Claims,  upon becoming aware thereof,  and permit PMC\nat PMC's cost to defend against such Claims and shall  cooperate with PMC in the\ndefense  thereof.  Recipient shall not enter into, or permit,  any settlement of\nany such Claims without the express written consent of PMC.\n\n*** Confidential Treatment Requested\n\n\n                                      -12-\n\n\nRecipient  may, at its option and expense,  have its own counsel  participate in\nany proceeding that is under the direction of PMC and will cooperate with PMC or\nits insurer in the disposition of any such matter.\n\n         7(c).    PMC's Right to Indemnification\n\n                  Recipient hereby agrees to indemnify, defend and hold harmless\nPMC and its  affiliates,  officers,  directors,  employees  and  representatives\n(collectively,  'PMC's  Indemnitees') from and against any liabilities,  claims,\ndamages,  costs,  expense  (including  reasonable  attorneys' fees), and actions\n(collectively,  'Claims')  arising  out of or  resulting  from (i) the  Clinical\nTrials, (ii) the failure by Recipient to manufacture,  test, document or release\nBEC2 in compliance with cGMP and the applicable  Regulatory  Filings,  (iii) the\nbreach by Recipient or Recipient's Indemnitees of any of Recipient's obligations\nor  warranties  under this  Agreement  or under the Clinical  Trial  Protocol or\nRegulatory  Filings,  (iv)  the  possession,   processing,   shipment,  storage,\nhandling,  administration  or disposal of any BCG Material supplied to Recipient\nhereunder,  or  (v)  the  possession,   manufacture,  sale,  use,  distribution,\nprocessing,  shipment, storage, handling,  administration or disposal of BEC2 by\nRecipient  whether or not any BCG  Material is combined  thereto,  except to the\nextent  that any such  Claims  arise out of, are based  upon or result  from the\ngross negligence or willful  misconduct of PMC or PMC's  Indemnitees or a breach\nby PMC or PMC's Indemnitees of any of PMC's obligations or warranties under this\nAgreement.  PMC shall  promptly  notify  Recipient of any Claims,  upon becoming\naware thereof,  and permit Recipient at Recipient 's cost to defend against such\nClaims and shall cooperate with Recipient in the defense thereof.  PMC shall not\nenter into, or permit,  any  settlement  of any such Claims  without the express\nwritten consent of Recipient.  PMC may, at its option and expense,  have its own\ncounsel  participate in any proceeding  that is under the direction of Recipient\nand will cooperate with Recipient or its insurer in the  disposition of any such\nmatter.\n\n         7(d).    Recipient's Insurance\n\n                  Each of ImClone and Merck shall obtain and  maintain  separate\nproduct liability  insurance and clinical trial liability  insurance (naming PMC\neither as an  additional  insured  or policy  beneficiary),  with an  acceptable\ninsurer,  in the minimum amount of US$10,000,000 per occurrence.  Such insurance\nmay not be cancelled or  terminated  except upon thirty (30) days' prior written\nnotice to PMC. Such insurance  shall be obtained and maintained at the sole cost\nand  expense of ImClone  and Merck.  From time to time,  at the  request of PMC,\nImClone and Merck will cause  certificates  of such  insurance to be provided to\nPMC evidencing compliance with their respective obligations set forth herein.\n\n*** Confidential Treatment Requested\n\n\n                                      -13-\n\n\n8.       Term and Termination\n\n         8(a).    Expiration\n\n                  This Agreement  shall commence on the Effective Date and shall\nterminate  six (6) months  after the  expiration  of the Supply  Period,  unless\nearlier  terminated  as  provided  in  Sections  8(b),  (c) and (d) hereof  (the\n'Term').\n\n         8(b).    Termination by Any Party\n\n                  Any party shall have the right to  terminate  this  Agreement,\nimmediately upon written notice of termination to the other parties in the event\nthat:\n\n                  (i) a party fails to perform or observe or otherwise  breaches\nany of its material  obligations under this Agreement and such failure or breach\ncontinues  unremedied  for a period of sixty  (60)  days  after  receipt  by the\nbreaching party of a written notice thereof from the non-breaching party; and\n\n                  (ii) a  proceeding  or case  shall be  commenced  without  the\napplication  or consent  of the other  party and such  proceeding  or case shall\ncontinue undismissed,  or an order, judgment or decree approving or ordering any\nof the  following  shall be entered and continue  unstayed and in effect,  for a\nperiod of  forty-five  (45) days from and after the date  service  of process is\neffected  upon the  other  party,  seeking  (A) the other  party's  liquidation,\nreorganization, dissolution or winding-up, or the composition or readjustment of\nits debts, (B) the appointment of a trustee, receiver, custodian, liquidation or\nthe  like of the  other  party  or of all or any  substantial  portion  of their\nassets,  or (C)  similar  relief in  respect  of the other  party  under any law\nrelating  to   bankruptcy,   insolvency,   reorganization,   winding-up  or  the\ncomposition or readjustment of debts.\n\n         8(c).    Termination due to Cessation of Clinical Trials\n\n                  In the  event  Recipient  in its sole  discretion  ceases  the\nClinical Trials,  and so advises PMC in writing in advance,  either Recipient or\nPMC may terminate  this  Agreement upon thirty (30) days prior written notice to\nthe other parties.\n\n         8(d).    Termination in Connection With Further Negotiation\n\n                  This  Agreement  may be  terminated by the Recipient or PMC in\nconnection with the failure, during the Term, to enter into a separate agreement\nfor future  commercial  supply of BCG Material,  as further set forth in Section\n2(e) hereof.\n\n         8(e).    Effects of Termination\n\n                  In the event of any termination of this Agreement, all amounts\npreviously  invoiced  and  unpaid  or owed to PMC  shall be due and  payable  by\nRecipient on the date of  termination.  Following  termination of the Agreement,\nthe Recipient shall return to PMC or\n\n*** Confidential Treatment Requested\n\n\n                                      -14-\n\n\ndestroy,  at PMC's option,  any  quantities  of BCG Material.  The parties agree\nthat: (i) the provisions of Section 2(e),  Article 3 and Article 6 shall survive\nthe termination or expiration of this Agreement;  (ii) the provisions of Article\n5 hereof shall survive the  termination  or expiration of this Agreement for the\nterm  specified in that  Article;  and (iii) the  provisions of Article 7 hereof\nshall survive  termination  or expiration of this Agreement only with respect to\nClaims that arose from acts or circumstances that occurred prior to termination.\n\n9.       Miscellaneous\n\n         9(a).    No Implied Waivers; Rights Cumulative\n\n                  No failure on the part of PMC or the  Recipient  to  exercise,\nand no delay in exercising,  any right,  power,  remedy or privilege  under this\nAgreement,  or  provided  by  statute  or at  law  or in  equity  or  otherwise,\nincluding,  without limitation,  the right or power to terminate this Agreement,\nshall impair,  prejudice or constitute a waiver of any such right, power, remedy\nor privilege  or be construed as a waiver of any breach of this  Agreement or as\nan acquiescence  therein,  nor shall any single or partial  exercise of any such\nright, power, remedy or privilege preclude any other or further exercise thereof\nor the exercise of any other right, power, remedy or privilege.\n\n         9(b).    Notices\n\n                  All notices,  requests and other  communications to PMC or the\nRecipient   hereunder  shall  be  in  writing  (including  telecopy  or  similar\nelectronic  transmissions) and shall be personally delivered or sent by telecopy\n(fax) or other  electronic  facsimile  transmission  or by  registered  mail, or\ncertified mail, return receipt requested,  postage prepaid,  or by other form of\ncourier requiring receipt in each case to the respective address specified below\n(or to such address as may be  specified  in writing to the other party  hereto)\nand shall be effective upon receipt thereof:\n\nConnaught Laboratories Limited\n1755 Steeles Avenue West\nToronto, Ontario, CANADA\nM2R 3T4\n\nAttn:    Vice President and General Counsel\n         Facsimile:        (416) 667-2860\nwith a copy to:   Senior Vice President, and General Manager,\n                    Oncology Business Unit\n         Facsimile:        (416) 667-2990\n\n*** Confidential Treatment Requested\n\n\n                                      -15-\n\n\nMerck KGaA\nFrankfurter Strasse 250\n64271 Darmstadt, GERMANY\n\nAttn:    Dr. Dieter Orth, License Department\n         Facsimile:        61 51 72 3378\nwith a copies to: Dr. Jurgen Uhl, Project Manager, Facsimile: 61 51 72 7580, and\n                           Lothar Finke, TATONZ, Facsimile: 61 51 72 6905\n\nImClone Systems Incorporated\n180 Varick Street\nNew York   NY 10014\nU.S.A.\n\nAttn:    General Counsel\n         Facsimile:        (212) 645-2054\n\n         9(c).    Successors and Assigns\n\n                  The terms and provisions of this Agreement  shall inure to the\nbenefit  of, and be binding  upon,  PMC,  the  Recipient,  and their  respective\nsuccessors and permitted assigns as provided in this Section.  PMC and Recipient\nshall  have the right to assign or  otherwise  transfer  any of its  rights  and\ninterests,  or delegate  any of its  obligations,  to an Affiliate of such party\nprovided  that  such  Affiliate  agrees  in  writing  to  carry  out in full any\nobligations  that are assigned to it. PMC and Recipient  shall have the right to\nassign all of its rights and interests and delegate all of its obligations under\nthis  Agreement to any entity that is the successor in interest to the assigning\nparty in any merger,  consolidation or sale involving  substantially  all of the\nbusiness and assets of the assigning  party.  Any other assignment or delegation\nshall only be valid and  effective  if the other  parties  have  provided  their\nrespective prior express written consent.  Any attempt to assign or delegate any\nportion of this  Agreement in violation of this Section  shall be null and void.\nSubject to the foregoing,  any reference to PMC or the Recipient hereunder shall\nbe deemed to include the successors thereto and permitted assigns thereof.\n\n         9(d).    Force Majeure\n\n                  No party shall be liable to the others, or be in default under\nthe  terms  of this  Agreement,  for its  failure  to  fulfill  its  obligations\nhereunder to the extent such  failure  arises for any reason or cause beyond its\ncontrol including,  without limitation,  strikes, lockouts, labor disputes, acts\nof God, acts of nature,  acts of governments  or their  agencies,  fire,  flood,\nstorm, power shortages or power failure, war, sabotage,  inability to supply and\nto obtain labor,  raw materials,  supplies,  fuel or utilities,  or inability to\nobtain transportation,  or any other circumstance or event beyond the reasonable\ncontrol of the party (each, 'Force Majeure'), provided that the party relying on\nthe  provisions  of this Section 9(d) shall give notice to the other  parties of\nits inability to observe or perform the  provisions of this  Agreement.  A party\nshall notify the other  parties if, at any time,  it  encounters a production or\nmanufacturing problem\n\n*** Confidential Treatment Requested\n\n\n                                      -16-\n\n\nwhich in its reasonable opinion could reasonably be expected to adversely affect\nits ability to supply BEC2 or BCG  Material,  as  applicable,  for the  Clinical\nTrials. Should such production or manufacturing be so reduced, the party relying\non these provisions shall have the right to allocate such supply for its own use\nand among its affiliates, customers and distributors, in such manner and on such\nbasis as it may reasonably  determine,  without  compensation  or penalty to the\nother parties.\n\n         9(e).    Governing Law\n\n         This  Agreement  shall  be  governed  by the  laws of the  Province  of\nOntario. The parties specifically agree that the International Sale of Goods Act\ndoes not apply hereto.\n\n         9(f).    Entire Agreement\n\n                  This  Agreement,  together  with  its  Exhibits  A,  B and  C,\nconstitutes, on and as of the Effective Date hereof, the entire agreement of and\namong PMC, ImClone and Merck with respect to the subject matter hereof,  and all\nprior or contemporaneous  understandings or agreements, whether written or oral,\nbetween or among PMC,  ImClone or Merck with respect to such subject  matter are\nhereby superseded, as of the Effective Date.\n\n         9(g)     Relationship\n\n                  Each of the parties is an independent contractor. No party is,\nand  nothing  in this  Agreement  shall  constitute  any party as the  employer,\nemployee,  principal,  agent or partner of, or joint  venturer  with,  any other\nparty. No party has authority to enter into any agreement on behalf of the other\nparties or to bind the other parties in any other manner, and no party shall act\nor omit to act so as to suggest that it has such authority. No party shall incur\nany  obligations  or  liabilities,  express  or  implied,  by reason of, or with\nrespect to, the actions or omissions of the other parties or of persons for whom\nthey are responsible.\n\n         9(h)     Counterparts\n\n                  This  Agreement  may be executed in two or more  counterparts,\neach of which  shall be  deemed  an  original  but all of which  together  shall\nconstitute one and the same instrument.\n\n*** Confidential Treatment Requested\n\n\n                                      -17-\n\n\n         IN WITNESS  WHEREOF,  the  parties  have caused  this  Agreement  to be\nexecuted by their duly authorized officers as of the Effective Date.\n\nImClone Systems Incorporated\n\n\nBy: \/s\/ John B. Landes\n    --------------------------\nName:    John B. Landes\nTitle: VP Business Development\n        and General Counsel\n\n\nMerck KGaA\n\n\nBy: \/s\/  Professor Schurr  18\/8\/98                \n    ------------------------------                \nName:    Professor Schurr                         \nTitle:   Vice President Clin. R&amp;D                 \n\n\nBy:      \/s\/ Dr. Dieter Orth         \n         ---------------------------   \nName:    Dr. Dieter Orth             \nTitle:   Head of Corporate Licensing \n\n\nConnaught Laboratories Limited\n\nBy:      \/s\/ Dr. Pierre Meulien                   \n         ----------------------                   \nName:    Dr. Pierre Meulien                       \nTitle:   Vice President                           \nResearch &amp; Development\n\n  \nBy:      \/s\/ Wm. M.M. Thoms         \n         -------------------         \nName:    Wm. M. Thoms                \nTitle:   VP &amp; General Counsel        \n\n*** Confidential Treatment Requested\n\n\n                                      -18-\n\n\n                Exhibit 'A' (Protocols, Investigators' Brochures)\n   to Agreement among PMC, ImClone and Merck effective as of January 1, 1997\n\n--------------------------------------------------------------------------------\n\n\n\n[ *** ]\n\n*** Confidential Treatment Requested\n\n\n                                      -19-\n\n\n          Exhibit 'B' (Section 2(a), ImClone's labelling requirements)\n    to Agreement among PMC, ImClone and Merck effective as of January 1, 1997\n\n--------------------------------------------------------------------------------\n\n\n                            BCG (lyophilized) 1.5 mg\n                          (An Active Immunizing Agent)\n                        For Intracutaneous Injection Only\n                          Dose as per Clinical Protocol\n                                      Lot:\n\n                                      Exp:\n\n                          For Investigational Use Only\n\n                    MUST NOT BE ADMINSTERED AS A SINGLE AGENT\n\n                       Mfg: Connaught Laboratories Limited\n                             North York, ONT Canada\n\n*** Confidential Treatment Requested\n\n\n                                      -20-\n\n\n           Exhibit 'C' (Section 2(a), Merck's labelling requirements)\n    to Agreement among PMC, ImClone and Merck effective as of January 1, 1997\n\n--------------------------------------------------------------------------------\n\n\n                            BCG (lyophilized) 1.5 mg\n                          (An Active Immunizing Agent)\n                        For Intracutaneous Injection Only\n                Use according to study protocol EORTC 08971 only\n\n                                                                     Lot:\n                                                                     Exp:\n\n                           For Clinical Trial Use Only\n\n                    MUST NOT BE ADMINSTERED AS A SINGLE AGENT\n\n                       Mfg: Connaught Laboratories Limited\n                             North York, ONT Canada\n\n*** Confidential Treatment Requested\n\n\n<\/pre>\n","protected":false},"template":"","meta":{"_acf_changed":false,"_stopmodifiedupdate":true,"_modified_date":"","_cloudinary_featured_overwrite":false},"corporate_contracts_companies":[7835],"corporate_contracts_industries":[9405],"corporate_contracts_types":[9613,9619],"class_list":["post-42021","corporate_contracts","type-corporate_contracts","status-publish","hentry","corporate_contracts_companies-imclone-inc","corporate_contracts_industries-drugs__biotech","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\/42021","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=42021"}],"wp:term":[{"taxonomy":"corporate_contracts_companies","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_companies?post=42021"},{"taxonomy":"corporate_contracts_industries","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_industries?post=42021"},{"taxonomy":"corporate_contracts_types","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_types?post=42021"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}