{"id":42134,"date":"2015-09-17T11:25:58","date_gmt":"2015-09-17T16:25:58","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-legal\/contracts\/uncategorized\/ciprofloxacin-supply-agreement-bayer-ag-bayer-corp-barr.html"},"modified":"2015-09-17T11:25:58","modified_gmt":"2015-09-17T16:25:58","slug":"ciprofloxacin-supply-agreement-bayer-ag-bayer-corp-barr","status":"publish","type":"corporate_contracts","link":"https:\/\/corporate.findlaw.com\/contracts\/operations\/ciprofloxacin-supply-agreement-bayer-ag-bayer-corp-barr.html","title":{"rendered":"Ciprofloxacin Supply Agreement &#8211; Bayer AG, Bayer Corp., Barr Laboratories Inc. and Hoechst Marion Roussel Inc."},"content":{"rendered":"<pre>                                 EXECUTION COPY\n                              SUPPLY AGREEMENT dated as of\n               January 8, 1997 (this 'Agreement'), by and\n               between BAYER AG, BAYER CORPORATION\n               ('Bayer US' and together with Bayer AG,\n               'Bayer'), BARR LABORATORIES, INC. ('Barr')\n               and HOECHST MARION ROUSSEL, INC. ('HMR').\n\n          WHEREAS Bayer AG, Bayer US and Barr entered into a\nSettlement Agreement and Mutual Release dated as of the date\nhereof (the 'Barr Settlement Agreement'), in the matter of\nlitigation relating to United States Patent No. 4,670,444\n(the '`444 Patent'), which claims, inter alia, the novel\ncompound commonly known as ciprofloxacin ('ciprofloxacin'),\nthen pending in the United States District Court for the\nSouthern District of New York (the 'District Court'), in\nwhich litigation Bayer AG and Bayer US were the plaintiffs\nand Barr was the defendant;\n          WHEREAS HMR and Rugby Laboratories, Inc. have\nmaintained co-control with Barr of the defense against\nBayer's claims in the litigation and have paid or reimbursed\nBarr for a portion of its cost of defending against Bayer's\nclaims in the litigation;\n          WHEREAS Bayer AG, Bayer US, HMR and Rugby\nLaboratories, Inc. entered into a Settlement Agreement and\n\nMutual Release dated as of the date hereof (the 'HMR\nSettlement Agreement');\n\n           ***\n\n\n\n                                        ***\n\n          WHEREAS the parties are entering into this\nAgreement as required by the Barr Settlement Agreement and\nthe HMR Settlement Agreement;\n          WHEREAS, in certain circumstances more fully\ndescribed herein, Bayer will manufacture and supply Barr and\nHMR (the 'Purchasers') with the Product (as defined below)\nas finished product for sale by Purchasers; and\n          WHEREAS Purchasers wish Bayer to make Product\navailable to them for purchase according to the provisions\nof this Agreement.\n\n          NOW, THEREFORE, Bayer AG, Bayer US and Barr and\nHMR agree as follows:\n\n                         ARTICLE I\n                        Definitions\n          SECTION 1.01.  Definitions.  The following terms\nshall have the following meanings:\n          'Adjustment Date' shall mean the date that is six\nmonths prior to the Final Expiration Date.\n          '***       Settlement Agreement' shall have the\nmeaning set forth in the recitals.\n          'Barr' shall mean Barr Laboratories, Inc.\n          'Barr Escrow Account' shall mean the escrow\naccount of Barr at Citibank N.A., or any other responsible\ninstitution, established to receive payments due to Barr\nunder the Barr Settlement Agreement and this Agreement.\n          'Barr Settlement Agreement' shall have the meaning\nset forth in the recitals.\n          'Barr's Aggregate Costs' shall have the meaning\nset forth in Section 3.06(d).\n          'Barr's Costs' shall have the meaning set forth in\nSection 3.06(d).\n          'Bayer' shall mean Bayer AG and Bayer US.\n          'Bayer Option' shall have the meaning set forth in\nSection 4.02.\n \n\n          'Bayer US' shall mean Bayer Corporation.\n          'Breaching Party' shall have the meaning set forth\nin Section 16.02(b).\n          'Calendar Quarter' shall mean each consecutive\nthree-month period beginning on either January 1, April 1,\nJuly 1 or October 1 of any given year.\n          'Determination Date' shall mean the earlier of\n(i) the Invalidity Date and (ii) the Generic Date.\n          'District Court' shall have the meaning set forth\nin the recitals.\n          'Final Expiration Date' shall have the meaning set\nforth in Section 7.01.\n          'Generic Date' shall mean the date of launch of a\ngeneric product in the United States containing\nciprofloxacin by a third party that is not licensed by Bayer\nafter the '444 Patent becomes invalid or unenforceable on a\nfinal and nonappealable basis as to such third party other\nthan due to the Invalidity Date.\n          'HMR' shall have the meaning set forth in the\nrecitals.\n          'HMR Settlement Agreement' shall have the meaning\nset forth in the recitals.\n          'Invalidity Date' shall mean the date of a final\nand nonappealable judgment or a final and nonappealable\n\n\n\ndeclaration that the `444 Patent is invalid or unenforceable\nas to all persons in the United States.\n          'Net Revenues' shall have the meaning set forth in\nSection 3.06(d).\n          'Net Sales' shall have the meaning set forth in\nSection 3.06(d).\n          'Net Selling Price' shall mean, ***\n\n\n\n\n\n\n\n                    *** during such relevant period.\n          'Option Date' shall mean the date specified in the\nOption Notice as the date on which Bayer's obligation to\nsupply Product to Purchasers shall commence, unless Bayer\nrevokes the Option Notice in accordance with Section 4.02.\n          'Option Notice' shall mean the notice delivered by\nBayer to Representative pursuant to Section 4.02 of this\nAgreement informing Representative of Bayer's intention to\nexercise the Bayer Option.\n\n\n\n          ''444 Patent' shall have the meaning set forth in\nthe recitals.\n          'Patents' shall mean the '444 Patent and all the\nother patents and patent applications and any divisions,\ncontinuations, continuations-in-part, reissues or extensions\nderived therefrom, related to the synthesis, manufacture,\ncompound or precursors to ciprofloxacin and any\npharmaceutical formulation containing ciprofloxacin existing\nin the United States as of the date of this Agreement that\nare owned by Bayer or any of its subsidiaries.\n          'Product' shall have the meaning set forth in\nArticle II.\n          'Product Specifications' shall have the meaning\nset forth in Article II.\n          'Put Price' shall have the meaning set forth in\nSection 3.06(a)(i).\n          'Quality Assurance Specifications' shall have the\nmeaning set forth in Section 3.05(b).\n          'Representative' shall have the meaning set forth\nin Section 9.02.\n          'Settlement Agreement' shall have the meaning set\nforth in the recitals.\n          'Settlement Agreements' shall have the meaning set\nforth in the recitals.\n\n\n\n          A 'SKU' shall mean a given package size of a given\nstrength of Product.\n          'Stub Period' shall mean the period from the\nearlier of the Option Date and the Adjustment Date until the\nearliest of the next March 31, June 30, September 30 or\nDecember 31.\n          A 'subsidiary', with respect to a party, shall\nmean any corporation, partnership, limited liability company\nor other entity the voting interests in which are owned 50%\nor more by that party.\n          'Supply Period' shall mean the period that\n(i) commences with the earlier of ***\n\n\n\n\n\n\n\n\n\n\n\n\n                              ***\n\n          'Termination Date' shall have the meaning set\nforth in Section 7.01.\n          'Trade Discounts' shall mean prompt payment\ndiscounts given by Bayer to encourage payment of trade\nreceivables prior to the net payment date.\n          'Trade Discount Percentage' shall mean, for a\nparticular Calendar Quarter, the percentage that is ***\n\n\n\n\n\n\n    ***\n\n                         ARTICLE II\n                          Product\n          For purposes of this Agreement, the term 'Product'\nshall mean all oral dosage forms of ciprofloxacin presently\nor subsequently marketed by Bayer or any of its subsidiaries\nin the United States under a New Drug Application or a\nSupplemental New Drug Application of Bayer or any of its\nsubsidiaries and pursuant to or under the authority of\n(i) the Patents or (ii) the Patents and other patents owned\nby Bayer or any of its subsidiaries, which conform to\n\nproduct specifications as approved from time to time by the\nFood and Drug Administration (the 'FDA'), except that during\nany period of market exclusivity for a particular SKU\ngranted by the FDA pursuant to the Patent Term Restoration\nAct of 1984, as amended, the term 'Product' shall not\ninclude such SKU.  The term 'Product' shall not include any\noral dosage forms of ciprofloxacin marketed pursuant to a\nNew Drug Application or Supplemental New Drug Application\nthat employs patented technology of a third party.  Within\n60 days of the date of this Agreement, Bayer will provide to\nthe Purchasers the current product specifications for the\nProduct (the 'Product Specifications').\n\n                        ARTICLE III\n             Manufacture and Supply of Product\n          SECTION 3.01.  Purchase and Sale of Product.\nSubject to the terms and conditions of this Agreement, Bayer\nshall supply Purchasers with Product.  Purchasers shall\npurchase and accept all of Purchasers' requirements for\nProduct from Bayer and shall have the right to sell Product\npurchased from Bayer only in the United States and Puerto\nRico and not elsewhere under a single trademark of the\nPurchasers; provided, that such trademark shall not be\nsimilar to CIPRO or any other trademark or tradename of\nBayer AG or any of its subsidiaries.  Product shall be\n\nmanufactured and packaged in accordance with Bayer's Product\nSpecifications.  Bayer's Product Specifications may be\naltered from time to time without the necessity of amending\nthis Agreement.\n          ***\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n          ***\n\n\n\n          SECTION 3.02.  Product To Be Supplied by Bayer.\n(a) Bayer will use its reasonable best efforts to supply\nPurchasers with the quantities of Product ordered by\nRepresentative in accordance with the terms of this\nAgreement; provided, however, that Bayer may supply\nPurchasers with quantities of Product that vary no more than\n***   the quantities stipulated in Representative's firm\norder; provided, further, that Bayer shall redress *** when\nsupplying subsequent orders.\n          (b)  Bayer shall offer for sale to Purchasers\nProduct packed in containers in the standard packaging and\nlabeling for, and made in the sizes, shapes, and colors and\nto the other specifications as, the Product offered at such\ntime by Bayer to Bayer's other customers except that nothing\nherein shall require Bayer to sell the Product or any\npackaging to the Purchasers with the trademark CIPRO or\nBayer's NDC number for CIPRO.\n\n          (c)  ***\n\n                              ***\n\n\n\n          SECTION 3.03.  Estimates, Orders and Delivery\nVariances.  (a)  At least     ***        before the\n\nbeginning of each Calendar Quarter in which Bayer is\nobligated to supply Purchasers with Product pursuant to this\nAgreement, Representative shall provide Bayer with a rolling\n***   forecast of its requirements of Product broken down by\ncalendar months.  This forecast will specify package size.\nThe  ***        calendar months of this forecast shall\nrepresent a firm order, which shall be supplied by Bayer to\nPurchasers in accordance with Representative's purchase\norders.  Purchase orders must be delivered to Bayer by\nRepresentative at least *** days prior to the shipment date\nrequested in such purchase order.  The requirements of the\nStub Period and the first firm order appear in paragraph (b)\nwhich follows.\n          (b)   At least      ***        prior to the\nanticipated first date of receipt of Product by the\nPurchasers hereunder ***, representatives of Bayer and\nRepresentative shall meet pursuant to Section 9.01(a) and\nnegotiate in good faith the quantities and delivery dates of\nProduct to be supplied in the Stub Period and the first\nCalendar Quarter thereafter.  If Product is to be delivered\nby Bayer *** or upon occurrence of the Adjustment Date or\npursuant to Section 3.06(c), Bayer shall use its reasonable\nbest efforts\n\n\n\n\nto supply the Purchaser with Product that Representative\ndetermines to be the Purchasers' reasonable requirement for\nthe Stub Period and the first Calendar Quarter thereafter.\nIn all other cases, Bayer shall use its reasonable best\nefforts to supply the Purchasers with the quantities of\nProduct that Representative and Bayer determine to be the\nPurchasers' requirements for the Stub Period and the first\nCalendar Quarter thereafter.  Representative shall place the\nfirst firm order at least     ***   in advance of the\nanticipated first date of receipt of Product (or as soon as\nreasonably practicable if *** is not possible); ***\n\n\n\n\n\n\n                                   ***.\n\n          (c)  As soon as is reasonably practicable prior to\nthe reasonably likely start of the Supply Period,\nrepresentatives of Bayer and the Representative shall meet\npursuant to Section 9.01(a) and negotiate in good faith the\nquantity and delivery dates of Product to be supplied during\n\n\n\nthe first      ***        of the Supply Period.  Bayer shall\nuse its reasonable best efforts to supply the Purchasers\nwith the quantities of Product that Bayer and the\nRepresentative determine to be the Purchasers' requirements\nfor such  ***        period.  ***\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n                                                       ***\n          SECTION 3.04.  Government Approvals. (a)  Bayer\nhas and will maintain with the FDA its existing New Drug\nApplications, and will maintain with the FDA any\n\n\nsubsequently approved New Drug Applications, relating to the\nProduct.\n          (b)  The parties shall promptly and fully advise\neach other of any instructions, recommendations or\nspecifications required by any government regulatory agency\nconcerning the Product.  Bayer shall notify Representative\nand Representative shall notify Bayer of any actions that\nBayer or Representative, as the case may be, intends to take\nin response to government regulatory agency requirements\nconcerning the Product.  Disclosures by any party to the\nother parties may be modified to protect such disclosing\nparty's proprietary information and technology.\n          (c)  The Purchasers shall immediately notify Bayer\nof all contacts with the FDA or other regulatory agencies\nconcerning Product.  If the Purchasers are required by the\nFDA to take any action with respect to Product without delay\nor without any element of discretionary action or decision,\nthe Purchasers shall immediately notify Bayer.  Purchasers\nshall promptly provide Bayer with copies of all material\nthat it submits to the FDA concerning Product and all other\ncommunications with the FDA concerning Product.\n          (d)  Each Purchaser will utilize an NDC number in\nthe form of XXXX-YYYY-ZZ for such Purchaser's sales and\ndistribution of Product.  Either Purchaser may change its\n\n\nNDC number with the consent of Bayer, which consent shall\nnot be unreasonably withheld.\n          SECTION 3.05.  Manufacture and Packaging of\nProduct.  (a)  Bayer shall manufacture and package the\nProduct in finished dosage units in conformity with the\nProduct Specifications.  All Product sold by a Purchaser\nshall have a label of that Purchaser stating an equivalent\nof 'Manufactured by Bayer Corporation' and displaying the\ntrademark of the Purchasers, and not displaying the mark\nCIPRO or any other trademark or tradename of Bayer AG or any\nof its subsidiaries.\n          Purchasers may make changes to the Product\nSpecifications relating to packaging and\/or labeling after\nmeeting with Bayer under Section 9.01 in order to reach\nagreement on implementation procedures; provided that any\nsuch changes (i) must comply with all FDA requirements and\n(ii) must be approved by Bayer, which approval shall not be\nunreasonably withheld.  Purchasers shall reimburse Bayer for\nall extra costs incurred by Bayer for making any such\nchanges, including the cost of destroying obsolete\npackaging, labeling or related materials.\n          Nothing contained herein shall prevent Bayer from\nmodifying its manufacturing or packaging specifications or\nthe Product labeling, so long as such changes conform to FDA\n\n\nrequirements and the NDAs relating to the Product.  Bayer\nshall notify Representative promptly following a final\ndecision to make or, if FDA approval is required, to seek\napproval for such changes, but in no event shall\nRepresentative be given less than forty-five (45) days\nadvance written notice of the fact and specifics of such\nmodification, unless a shorter time is required to comply\nwith FDA requirements.\n          (b)  Bayer's quality assurance procedures and\nin-plant quality assurance checks after the manufacture of\nProduct shall be applied in conformity with the requirements\nof the FDA and with the quality assurance specifications for\nthe Product (which may be modified to the extent necessary\nto protect Bayer's proprietary information) (the 'Quality\nAssurance Specifications') to be supplied by Bayer to the\nPurchasers within 60 days of the date of this Agreement, and\nwhich shall thereafter be modified as required by applicable\ngovernment regulation.\n          (c)  Representative shall have the right once per\nyear, upon thirty (30) days' prior written notice, to\narrange for an inspection by an independent mutually\nacceptable inspector, during regular business hours, of\nBayer's production facilities used, or to be qualified for\nuse, in connection with the manufacture of Product for\n\n\nRepresentative.  Such inspection shall be limited to Bayer's\ncompliance with then current GMP regulations in the\nproduction, testing and storage of the Product.  The\ninspection report contents shall be limited to advising\nwhether Bayer does, or does not, comply with such\nregulations.  Any such inspector shall be required to\nexecute a confidentiality agreement consistent with this\nSection 3.05(c) and in the form reasonably requested by\nBayer prior to any such inspection.\n          (d)  Quality assurance and analytical records will\nbe maintained by Bayer as required by relevant regulatory\nagencies, and copies thereof will be made available to\nRepresentative if requested.\n          (e)  Each Product container shall show the lot\nnumber(s), clearly distinct from all other numerical\nidentifications, and such lot number(s) shall be on the\nshipping documents.\n          SECTION 3.06.  Pricing.  ***\n\n\n\n\n                                                       ***\n\n\n\n\n***\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n                                                       ***\n\n\n\n***\n\n\n\n\n\n\n\n\n\n\n\n\n\n                                             ***\n          (c)  Bayer reserves the right to enter into\nlicense or supply agreements with other persons for the sale\nof Product in the United States.  In this connection,\n'Private Label Distributor' shall mean a person (other than\nthe Purchasers) which markets Product in the United States\nunder a tradename or trademark which is not CIPRO (or such\nother tradename or trademark under which Bayer is marketing\nthe Product).  Bayer agrees that the Purchasers shall have\nat                            ***\n\n\n*** before Bayer may allow a Private Label Distributor to\nenter the market. ***\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n                                   ***\n\n\n\n          ***\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n                                                       ***\n\n\n\n***\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n                                                       ***\n\n\n\n***\n\n\n\n\n\n\n\n\n\n                    ***\n          SECTION 3.07.  Payment.  ***\n\n\n\n\n\n\n\n\n                              ***\n          (c)  Product shall be made available for shipping\nF.O.B., Bayer's designated facility within the continental\nUnited States or Puerto Rico.  Bayer shall arrange for\n\n\nshipping of Product from the continental United States or\nPuerto Rico to each Purchaser's facilities designated in\nRepresentative's weekly shipping schedule, at that\nPurchaser's expense, and title and risk of loss shall pass\nupon delivery to the carrier.\n          (d)  Notwithstanding anything to the contrary\nherein, if any Purchaser is more than 90 days in arrears in\nits payments to Bayer for Product, Bayer may suspend future\nshipments of Product until such time as such payments are\nmade current, unless the total amount in arrears is being\ndisputed in good faith by such Purchaser.\n          SECTION 3.08.  Requirements.  Each Purchaser shall\npurchase from Bayer 100% of its requirements for the Product\nto be sold in the United States and Puerto Rico.\n          SECTION 3.09.  Floor Stock Price Protection.\n(a)  This Section 3.09(a) shall apply ***\n\n\n\n\n                                                  ***\n\n\n\n\n\n\n***\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n                    ***\n\n\n\n\n     ***\n\n                                                       ***\n\n                         ARTICLE IV\n                              ***\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n                                                       ***\n\n\n***\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n                                                       ***\n\n\n\n***\n\n                                             ***\n          SECTION 4.02.  Bayer Option.  On ***\nprior written notice to Representative, Bayer may elect, in\nits sole discretion, to cease making the payments to the\n***        set forth in Schedule 4.01 (the 'Bayer Option').\n***\n\n\n\n\n\n\n          ***\n\n                         ARTICLE V\n              Labeling and Medical Information\n          Bayer shall supply to Representative such medical\nand labeling information as is reasonably required by a\ndiligent pharmaceutical company to support the registration\nof the Product and to ensure that Purchasers can undertake\nand fulfill their legal, regulatory and medical\nresponsibilities relating to its sale of the Product.  For\nthe same reason, Bayer shall supply copies of its\n\npromotional materials (but with no element of pricing\ninformation) to Representative to assist Purchasers in\nensuring that their own promotional materials are consistent\nand not capable of introducing ambiguities or differences of\ninterpretation in the marketplace.\n          Bayer shall ensure that Representative has\nreasonable access to Bayer's medical information and\nsummaries of safety and effectiveness data provided to the\nFDA in connection with the Product at the time of Product\napproval, as supplemented from time to time.  Bayer shall\nprovide such additional information and materials reasonably\nrequested by Representative relating to the foregoing,\nincluding labeling, package inserts and product packaging.\n          Bayer shall arrange meetings to take place between\nRepresentative and Bayer's representatives as soon as\npracticable before Purchasers commence sales of Product to\ndiscuss medical and regulatory information concerning the\nProduct.\n\n                         ARTICLE VI\n                         Warranties\n          SECTION 6.01.  Bayer agrees that all Product\ndelivered to Purchasers pursuant to this Agreement shall\nnot, at the time of delivery, be adulterated or misbranded\nwithin the meaning of the Federal Food, Drug and Cosmetic\n\n Act of the United States of America, as amended, as such\nAct is constituted and effective at the time of delivery,\nand the Product will not be an article which may not, under\nthe provisions of Sections 404 and 505 of such Act, be\nintroduced into interstate commerce.\n          SECTION 6.02.  Bayer warrants that Product\ndelivered to Purchasers pursuant to this Agreement shall\nconform with the Product Specifications, as amended from\ntime to time, and the Quality Assurance Specifications, as\namended from time to time, and shall conform to the relevant\nFDA requirements.  BAYER MAKES NO OTHER WARRANTIES, EXPRESS\nOR IMPLIED, WITH RESPECT TO THE PRODUCT.  ALL OTHER\nWARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT\nLIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND\nFITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED BY\nBAYER.  Except for damages which arise out of or are\nattributable to any act or omission on the part of Bayer,\nBayer shall not be liable for indirect damages resulting\nfrom Product sold under this Agreement.\n          SECTION 6.03.  Bayer shall indemnify and hold\nPurchasers harmless from and against all claims, causes of\naction, settlement costs including reasonable attorneys'\n\n\n\n\nfees, losses or liabilities and expenses of whatever nature\nwhich arise from or are attributable to:\n          (a) any Product characteristic or any\n     manufacturing defect or failure to meet the Product\n     Specifications and Quality Assurance Specifications\n     during or as a result of manufacture of the Product by\n     Bayer; or\n          (b) any negligent act or omission on the part of\n     Bayer's employees, agents or representatives.\nIn the event of any such claim against a Purchaser or any\nPurchaser affiliate or any agent, director, officer or\nemployee, that Purchaser shall promptly notify Bayer in\nwriting of the claim and Bayer shall manage and control, at\nits sole expense, the defense of the claim and its\nsettlement.  That Purchaser shall cooperate with Bayer and\nmay, at its option and expense, participate in any such\naction or proceeding.\n          SECTION 6.04.  Each Purchaser shall indemnify and\nhold Bayer harmless from and against all claims, causes of\naction, settlement costs, including reasonable attorneys'\nfees, losses or liabilities and expenses of any kind\nasserted by third persons which arise out of or are\nattributable to any negligent act or omission on the part of\nthat Purchaser or its employees, agents or representatives.\n\n\n          In the event of any such claim against Bayer, or\nany Bayer affiliate or any agent, director, officer or\nemployee, Bayer shall promptly notify the relevant Purchaser\nin writing of the claim, and that Purchaser shall manage and\ncontrol, at its sole expense, the defense of the claim and\nits settlement.  Bayer shall cooperate with that Purchaser\nand may, at its option and expense, participate in any such\naction or proceeding.\n          SECTION 6.05.  In the event that the FDA requires\nwithdrawal of Product from the market, or as soon as any\nparty is required to recall or is considering the recall of\nthe Product, it shall immediately advise the other and, at\nthe same time, provide the other with all information\nleading to the need for such recall or the consideration of\nit.  Such party will use its reasonable efforts to ensure\nthat the others are given ample opportunity to participate\nin all meetings with the FDA, and to the extent possible,\nthe parties shall together use their good faith efforts to\nremedy the cause of the withdrawal or recall.  It is\nintended by the parties, by inclusion of this provision,\nthat there are no arbitrary one-sided decisions to recall\nthe Product in the United States or Puerto Rico, without\nfirst ensuring well-informed and co-operative discourse\namong the parties.\n\n\n          Reasonable costs (but not including loss of\nprofits) associated with any recall or withdrawal of Product\nhereunder, including the replacement Product manufactured by\nBayer, shall be borne by the party whose acts or omissions\nresulted in the need for the recall or withdrawal.\n          If the recall or withdrawal of Product hereunder\narises from an act or omission of Bayer, Bayer shall\nimmediately replace, at Bayer's expense, the Product so\nrecalled or withdrawn, so that the Purchasers' businesses\nare interrupted as little as possible.\n          SECTION 6.06.  Each party will advise the others\nwithin five (5) working days of the details of any\nsignificant Product complaint which it may receive as to the\nsafety or efficacy of the Product, or significant and\/or\nrepetitive adverse reactions to the Product.\n\n                        ARTICLE VII\n                    Term and Termination\n          SECTION 7.01.  This Agreement shall terminate on\nthe date (the 'Termination Date') that is the earlier of the\ndate of final expiration of the `444 Patent (the 'Final\nExpiration Date') and the expiration of the Supply Period;\nprovided, however, that such date shall be extended if\nnecessary to permit the Supply Period to have a length of\nsix months.\n\n          SECTION 7.02.  Termination or expiration of this\nAgreement by any means and for any reason shall not relieve\nthe parties of any obligation accruing concurrently\ntherewith or prior thereto and shall be without prejudice to\nthe rights and remedies of any party with respect to any\nbreach of any of the provisions of this Agreement.\n\n                        ARTICLE VIII\n                       Force Majeure\n          SECTION 8.01.  Any delay in the performance of any\nof the duties or obligations of either party hereto (except\nthe payment of money) shall not be considered a breach of\nthis Agreement and the time required for performance shall\nbe extended for a period equal to the period of such delay;\nprovided that such delay has been caused by or is the result\nof any acts of God; acts of the public enemy; insurrections;\nriots; embargoes; labor disputes, such as strikes, lockouts\nor boycotts; fires; explosions; floods; earthquakes;\nmudslides; or other unforeseeable causes beyond the control\nand without the fault or negligence of the party so\naffected.  The party so affected shall give prompt notice to\nthe other party of such cause, and shall take whatever\nreasonable steps are necessary to relieve the effect of such\ncause as rapidly as possible.\n\n\n          SECTION 8.02.  Should any event of force majeure\ninterrupt or reduce the manufacturing capacity of Bayer so\nas to limit Bayer's ability to produce sufficient Product\nfor its and for Purchasers' requirements hereunder, then the\nquantity of Product which still can be produced by Bayer (if\nany) shall be allocated between the parties in such\nproportions as recognizes the share in the volume of Product\nmanufactured by Bayer during *** represented by Purchasers'\npurchases of Product during such period (if Product has been\n***, the Purchasers' *** forecast of its requirements (that\nwas delivered to Bayer pursuant to Section 3.03) shall be\ndeemed to be the volume of Purchasers' purchases of Product\nduring *** for purposes of this calculation).\n\n                         ARTICLE IX\n                    Additional Covenants\n          SECTION 9.01.  Meetings.  (a)  On a regularly\nscheduled basis, representatives of Bayer and Representative\nshall meet to confer on the implementation of the\ntransactions contemplated by this Agreement.\n\n\n\n\n\n\n          (b)  ***, through meetings held pursuant to\nSection 9.01(a), Representative will coordinate with Bayer\nto resolve all labeling, tooling, brochure and packaging\nissues.  The Purchasers shall promptly reimburse Bayer for\nall reasonable startup costs including expenses related to\ntooling and dies incurred by Bayer to prepare for supplying\nProduct to the Purchasers.\n          ***\n\n\n\n\n\n\n\n\n\n\n\n                         ***\n          SECTION 9.02.  Appointment of Representative for\nthe Purchasers.  Barr and HMR hereby appoint Barr as their\nrepresentative (the 'Representative') to act on behalf of\neach of them as set forth herein.  Barr and HMR may replace\n\n\nthe Representative by delivery of notice to Bayer AG and\nBayer US of their replacement of the Representative, which\nnotice shall contain such replacement Representative's name,\naddress and fax number.  Barr and HMR agree to form a joint\nventure partnership no later than July 1, 1997, and to\nappoint that partnership to be the Representative promptly\nthereafter.\n\n                         ARTICLE X\n                          Notices\n          Any certificate, notice or notification to any\nparty required, permitted or contemplated hereunder will be\nin writing, will be addressed to the party or parties to be\nnotified at the address set forth below, or at such other\naddress as each party may designate for itself from time to\ntime by notice hereunder, and will be deemed to have been\nvalidly served, given or delivered (i) the fifth business\nday after such notice was delivered to a regularly scheduled\novernight delivery carrier with delivery fees either prepaid\nor an arrangement, satisfactory to such carrier, made for\nthe payment of such fees, or (ii) upon receipt of notice\n\n\n\n\n\ngiven by telecopy, mailgram, telegram, telex, or personal\ndelivery:\n     To Bayer AG:        Bayer AG\n                         D-51368 Leverkusen\n                         Konzernbereich Recht,\n                          Patente\/Lizenzen und\n                          Versicherungen\n                         Germany\n                         Attention: General Counsel\n\n                         Fax:  49-214-30-50848\n\n                         To Bayer US:        Bayer\n                         Corporation\n                         One Mellon Bank Center\n                         Pittsburgh, PA 15219-2507\n                         Attention:  General Counsel\n                         Fax: 412-394-5580\n\n                         With a copy to:     Bayer\n                         Corporation\n                         Pharmaceuticals Division\n                         400 Morgan Lane\n                         West Haven, CT 06516-4175\n                         Attention: General Counsel\n\n                         Fax:  203-812-2795\n\n     To Barr:            Barr Laboratories, Inc.\n                         2 Quaker Road\n                         Pomona, NY 10970\n                         Attention: General Counsel\n\n                         Fax:  914-353-8419\n\n     To HMR:             Hoechst Marion Roussel, Inc.\n                         10236 Marion Park Drive\n                         Kansas City, MO 64134-0627\n                         Attention: General Counsel\n\n                         Fax:  816-966-3805\n\n     To Representative:  Barr Laboratories, Inc.\n                         2 Quaker Road\n                         Pomona, NY 10970\n                         Attention: General Counsel\n\n                         Fax:  914-353-8419\n\n\n     With a copy to:     Hoechst Marion Roussel, Inc.\n                         10236 Marion Park Drive\n                         Kansas City, MO 64134-0627\n                         Attention: General Counsel\n\n                         Fax:  816-966-3805\n\nAll notices to Bayer must be delivered to Bayer AG and to\nBayer US.\n                         ARTICLE XI\n                     Limited License\n          SECTION 11.01.  (a)  The Purchasers are herein\ngranted a license that is limited to enabling them to\nperform those activities permitted hereunder with respect to\nProduct for sale in the United States or Puerto Rico;\nprovided, however, that such license shall not be construed\nas permitting, explicitly or implicitly, any action or\nactivity by the Purchasers either (i) outside the United\nStates or Puerto Rico or (ii) that is not specifically\nauthorized by this Agreement.\n          (b)  Following the termination of this Agreement,\nunless said termination is due to a breach of this Agreement\nby a Breaching Party as determined by a court of competent\n\njurisdiction or by arbitration as provided herein, the\nPurchasers may manufacture and distribute Product in the\nsame sizes, shapes and colors as Product offered for sale by\nBayer in the United States or Puerto Rico as of the date of\ntermination (but no license is granted as to the containers\nin which Product is sold), subject to any patent rights of\nBayer or its subsidiaries that are in force at such time.\nFor the avoidance of doubt, the Purchasers shall have no\nright to use any trademark (other than trademarks relating\nto size, shape or color of the Product), tradename, patents,\nproprietary technology or logo used by Bayer or its\nsubsidiaries.\n          SECTION 11.02.***\n\n\n\n\n\n\n\n\n\n\n\n\n                                                      ***\n\n***\n\n\n\n\n\n\n\n\n\n\n\n\n                                       ***.\n                        ARTICLE XII\n                       Applicable Law\n          This Agreement will be interpreted and the rights\nand liabilities of the parties hereto determined in\naccordance with the local law of the State of New York,\nexcluding any conflicts of law or choice of law, rule or\nprinciple that might otherwise refer construction or\ninterpretation of this Agreement to the substantive law of\nanother jurisdiction.  The parties expressly exclude the\n\n\napplication of any provisions of the United Nations\nConvention on Contracts for the International Sale of Goods\nto this Agreement.\n\n                        ARTICLE XIII\n                 Confidentiality; Publicity\n          SECTION 13.01.  Confidentiality.  With the\nintention to keep the terms of this Agreement confidential,\nBayer AG, Bayer US, Barr and HMR, on their own behalf and on\nbehalf of their respective officers, directors, employees,\nagents, affiliates, attorneys and advisors, hereby agree to\nuse their respective reasonable best efforts not to disclose\nthe terms of this Agreement, except as required by law,\nregulation governmental authority or stock exchange\nregulation.\n          SECTION 13.02.  Publicity.  Except as the parties\nhave agreed in the Settlement Agreements or may otherwise\nagree in writing, the parties shall not make any disclosures\nconcerning the terms of this Agreement, except in conformity\nwith Section 13.01.\n\n                        ARTICLE XIV\n                         Assignment\n          ***\n                                                       ***\n\n***\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n                                                       ***\n\n\n\n***\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n                                                       ***\n\n                         ARTICLE XV\n                       Effectiveness\n          This Agreement shall become effective upon the\nentry by the District Court of the Consent Judgment.  If\nsuch entry does not occur, this Agreement shall be null and\nvoid and of no force and effect.\n\n                        ARTICLE XVI\n                     Dispute Resolution\n          SECTION 16.01.  (a)  General.  The parties\nrecognize that a bona fide dispute as to certain matters may\narise from time to time during the term of this Agreement\nthat may relate to the parties' rights and\/or obligations\nhereunder.  The parties agree that they shall use all\nreasonable efforts to resolve any dispute that may arise in\nan amicable manner.\n          (b)  Management Resolution.  If the parties are\nunable to resolve such a dispute within thirty (30) days,\nany party may, by notice to the other parties, have such\ndispute referred to the respective nominees of the parties.\nSuch nominees shall attempt to resolve the referred dispute\nby good faith negotiations within thirty (30) days after\nsuch notice is received.  If the designated nominees are not\nable to resolve such dispute within such thirty (30) day\n\n\nperiod, then the parties shall select a mediator to aid them\nin resolving such dispute through the Center for Public\nResources.  If the parties do not agree to pursue mediation\nor, pursuant to such mediation the parties do not resolve\ntheir dispute, the parties shall at such time initiate\narbitration under the Rules of the American Arbitration\nAssociation then in effect.  The arbitration proceedings\nshall be held in New York, New York.\n          SECTION 16.02.  Injunctive Relief and Damages.\n(a)  Notwithstanding Section 16.01 above, the complaining\nparty reserves the right to seek injunctive or other legal\nor equitable relief, in a court of competent jurisdiction,\nif, at its election, the complaining party reasonably\nbelieves that such relief is necessary.  In the event of a\nbreach by any party of any of its obligations under this\nAgreement, in addition to being entitled to exercise all\nrights granted by law, any other party to this Agreement\nwill be entitled to specific performance of its rights\nhereunder.  Each party agrees that monetary damages would\nnot be adequate compensation for any loss incurred by reason\nof a breach by it of any of the provisions of this Agreement\nand hereby further agrees that, in the event of any action\nfor specific performance in respect of such breach, it shall\nwaive the defense that a remedy at law would be adequate.\n\n\nIn addition, in the event that any party breaches any of its\nobligations under this Agreement, any other party is\nentitled to any damages from the breaching party resulting\nfrom that breach that it proves in litigation to enforce or\nterminate this Agreement.\n          (b)  A breach of a provision of this Agreement or\na Settlement Agreement by a party to any such agreement\nother than Bayer (a 'Breaching Party') that results in a\nmaterial adverse effect on the value to Bayer of the Patents\ntaken as a whole either in the United States or worldwide\nshall constitute a breach of this Agreement.  In such event,\nBayer may pursue its remedies for such breach against the\nPurchasers, except that Bayer may not pursue remedies for\nmoney damages against any party other than the Breaching\nParty.\n          (c)  Upon a breach of this Agreement, the\nBreaching Party (or if the Breaching Party is not a\nPurchaser, the Purchaser that is an affiliate of the\nBreaching Party) shall reimburse Bayer for Bayer's cost of\nall supplies purchased and on hand or on irrevocable order,\nif such supplies were ordered by Bayer based on firm\npurchase orders and such supplies cannot be reasonably used\nby Bayer for other purposes.  Bayer shall invoice the\nBreaching Party for amounts due hereunder within sixty\n(60) days.\n\n                        ARTICLE XVII\n             Waiver--Modification of Agreement\n          No waiver or modification of any of the terms of\nthis Agreement shall be valid unless in writing and signed\nby authorized representatives of the parties hereto.\nFailure by either party to enforce any rights under this\nAgreement shall not be construed as a waiver of such rights\nnor shall a waiver by a party in one or more instances be\nconstrued as constituting a continuing waiver or as a waiver\nin other instances.\n\n                       ARTICLE XVIII\n                        Severability\n          If any term or provision of this Agreement shall\nfor any reason be held invalid, illegal or unenforceable in\nany respect, such invalidity, illegality or unenforceability\nshall not affect any other term or provision hereof, and\nthis Agreement shall be interpreted and construed as if such\nterm or provision, to the extent the same shall have been\nheld to be invalid, illegal or unenforceable, had never been\ncontained herein.  ***\n\n\n\n\n                                                  ***\n\n***\n\n\n\n\n\n\n                                                  ***\n\n                        ARTICLE XIX\n                          Headings\n          The headings contained in this Agreement are for\nreference purposes only and shall not affect in any way the\nmeaning or interpretation of this Agreement.\n\n                         ARTICLE XX\n                            VAT\n          ***\n\n\n\n\n\n                         ***\n\n          The parties intending to be bound by the terms and\nconditions hereof have caused this Agreement to be signed by\ntheir duly authorized representatives on the date first\nabove written.\n\n                              BARR LABORATORIES, INC.\n                              \n                                by\n                              \n                                  Name:\n                                  Title:\n                              \n                              HOECHST MARION ROUSSEL, INC.,\n                              \n                                by\n                              \n                                  Name:\n                                  Title:\n                              \n                              BAYER AG,\n                              \n                                by\n                                   ____________________\n                                   Name:\n                                   Title:\n\n\n                              BAYER CORPORATION,\n                              \n                                by\n                              \n                                  Name:\n                                  Title:\n<\/pre>\n","protected":false},"template":"","meta":{"_acf_changed":false,"_stopmodifiedupdate":true,"_modified_date":"","_cloudinary_featured_overwrite":false},"corporate_contracts_companies":[6812,6859,6867],"corporate_contracts_industries":[9451,9407],"corporate_contracts_types":[9613,9619],"class_list":["post-42134","corporate_contracts","type-corporate_contracts","status-publish","hentry","corporate_contracts_companies-aventis","corporate_contracts_companies-barr-laboratories-inc","corporate_contracts_companies-bayer-ag","corporate_contracts_industries-manufacturing__chemicals","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\/42134","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=42134"}],"wp:term":[{"taxonomy":"corporate_contracts_companies","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_companies?post=42134"},{"taxonomy":"corporate_contracts_industries","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_industries?post=42134"},{"taxonomy":"corporate_contracts_types","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_types?post=42134"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}