{"id":42516,"date":"2015-09-17T11:25:58","date_gmt":"2015-09-17T16:25:58","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-legal\/contracts\/uncategorized\/manufacturing-services-agreement-bio-technology-general-corp.html"},"modified":"2015-09-17T11:25:58","modified_gmt":"2015-09-17T16:25:58","slug":"manufacturing-services-agreement-bio-technology-general-corp","status":"publish","type":"corporate_contracts","link":"https:\/\/corporate.findlaw.com\/contracts\/operations\/manufacturing-services-agreement-bio-technology-general-corp.html","title":{"rendered":"Manufacturing Services Agreement &#8211; Bio-Technology General Corp. and Bio-Technology General (Israel) Ltd."},"content":{"rendered":"<pre>\n                        MANUFACTURING SERVICES AGREEMENT\n\n      THIS AGREEMENT (the 'AGREEMENT') is entered into effective as of January\n1, 1996, by and between Bio-Technology General (Israel) Ltd., a corporation\nformed under the laws of Israel, having an address at Kiryat Weizmann, Rehovot\n76326, Israel ('BTG Israel'), and Bio-Technology General Corp. ('BTG U.S.'), a\nDelaware corporation, having an address at 70 Wood Avenue South, Iselin, New\nJersey 08830 (collectively, the 'Parties').\n\n\n                              W I T N E S S E T H :\n\n      WHEREAS, BTG U.S. requires manufacturing for commercial sale of its\nproducts and has need for processing capacity for a specified time and in a\nspecified manner;\n\n      WHEREAS, BTG Israel possesses suitable drug substance manufacturing\nfacilities for product required by BTG U.S., and will use its best efforts to\nmanufacture product in a timely manner according to BTG U.S.'s specifications\nand in accordance with good manufacturing practices and the terms of this\nAgreement;\n\n      WHEREAS, BTG U.S. has engaged BTG Israel to process certain quantities of\nproduct; and\n\n      WHEREAS, BTG U.S. and BTG Israel desire to amend and restate the terms\nunder which BTG Israel will continue to provide manufacturing services to BTG\nU.S.\n\n      NOW THEREFORE, in consideration of the foregoing premises, which are\nincorporated into and made a part of this Agreement, and of the mutual covenants\nwhich are recited herein, the parties agree as follows:\n\n\n                             ARTICLE I - DEFINITIONS\n\n      Each of the following defined terms means the singular or the plural as\nrequired by the context in which the term appears:\n\n      1.1 'AFFILIATE' shall mean a Person that directly, or indirectly through\none or more intermediaries, controls, is controlled by or is under common\ncontrol with, such Person. 'CONTROL' (and, with correlative meanings, the terms\n'CONTROLLED BY' and 'UNDER COMMON CONTROL WITH') shall mean the possession of\nthe power to direct or cause the direction of the management and policies of\nsuch Person, whether through the ownership of voting stock, by contract or\notherwise. In the case of a corporation 'CONTROL' shall mean, among other\nthings, the direct or indirect ownership of more than fifty percent (50%) of\nsuch corporation's outstanding voting stock.\n\n\n\n\n\n\n      1.2 'APPROVAL DATE' as applied to each Batch, shall mean the date on which\nBTG Israel's Quality Control Department approves the related Batch records and\nreleases the Product for delivery.\n\n      1.3 'BATCH' shall mean all material intended to have uniform character and\nquality that is produced from a single manufacturing procedure in accordance\nwith established parameters and according to a single manufacturing order during\nthat same cycle of manufacture.\n\n      1.4   'COST OF MANUFACTURING' shall mean the sum of:\n\n              (i) the direct labor costs, including benefits, associated with\n      making and fully packaging each Product; and\n\n             (ii) the manufacturing plant overhead costs associated with making\n      and fully packaging each Product, including without limitation:\n      manufacturing plant administrative salaries, including benefits; rent;\n      equipment and manufacturing plant maintenance; real estate taxes;\n      utilities; insurance; depreciation; amortization; and quality control\n      costs.\n\nAll such costs shall be calculated in accordance with United States generally\naccepted accounting principles consistently applied.\n\n      1.5 'FACILITY' shall mean BTG Israel's manufacturing facility located at\nKiryat Weizmann, Rehovot, Israel.\n\n      1.6 'FDA' shall mean the United States Food and Drug Administration.\n\n      1.7 'MARGIN' shall mean a specified percentage of the Cost of\nManufacturing determined annually by good faith negotiation between BTG Israel\nand BTG U.S. based upon the percentage an unrelated third party would charge BTG\nU.S. on an arms' length basis for the services rendered by BTG Israel hereunder.\n\n      1.8 'MASTER BATCH RECORD' shall mean the criteria, methodology,\nmanufacturing Process, Specifications and formulae for each Product, which\nincludes the identity and quantities of the Raw Materials and other components,\nas set forth in a schedule hereto to be agreed to by the Parties at the time BTG\nU.S. engages BTG Israel to manufacture a particular Product, as such may be\namended by mutual agreement of the Parties from time to time.\n\n      1.9 'PERSON' shall mean any individual, partnership, association,\ngovernmental instrumentality, corporation, trust or other legal person or\nentity.\n\n                                       -2-\n\n\n\n\n      1.10 'PROCESSING,' 'PROCESS,' and 'PROCESSED' shall have comparable\nmeanings and shall mean the act of manufacturing and inspecting Product in\naccordance with the Master Batch Record and specified procedures.\n\n      1.11 'PROCESSING FEE' shall mean the consideration payable to BTG Israel\nfor Processing each Batch of Product as specified in Section 4.1.2.\n\n      1.12 'PRODUCT' shall mean those products from time to time set forth in a\nschedule hereto which BTG U.S. requests that BTG Israel Process and BTG Israel\nagrees to Process.\n\n      1.13 'PROPRIETARY INFORMATION' shall mean all confidential information\ndisclosed by one Party to the other at any time prior to or during the term of\nthis Agreement pursuant to or in furtherance of this Agreement, except that\nwhich the Party receiving such Proprietary Information can establish by\ncompetent evidence:\n\n            (i) was known to the receiving Party or any of its Affiliates at the\n      time of disclosure;\n\n            (ii) was generally available to the public or was otherwise part of\n      the public domain at the time of disclosure;\n\n            (iii) became generally available to the public or became otherwise\n      part of the public domain after disclosure other than through any act or\n      omission of the receiving Party in breach of this Agreement;\n\n            (iv) was independently developed by the receiving Party or any of\n      its Affiliates without the aid, application or use of the Proprietary\n      Information disclosed; or\n\n            (v) became known to the receiving Party after disclosure from a\n      source who had the lawful right to disclose such information, other than\n      the disclosing Party and other than from a third party who had an\n      obligation to the disclosing Party not to disclose such information to\n      others.\n\nThe Specifications and all Batch Records and other information generated by BTG\nIsrael with respect to Processing shall be deemed the Proprietary Information of\nBTG U.S., with the exception of information (other than know-how of BTG U.S.)\nrelating to Process improvements made by BTG Israel in its existing technology\nwhich are generally applicable to the manufacture of pharmaceutical products.\n\n      1.14 'PURCHASE ORDER' shall mean the document originated by BTG U.S. which\nsets forth the quantities of each Product ordered and delivery dates mutually\nagreed to by the Parties.\n\n\n                                    -3-\n\n\n\n\n\n\n      1.15 'RAW MATERIALS' shall mean excipients and associated manufacturing\ncomponents, as all of the foregoing are utilized in Processing.\n\n      1.16 'REGULATORY AUTHORITIES' shall mean the FDA and all other\ngovernmental or regulatory authorities having jurisdiction over the manufacture\nand commercial sale of any Product.\n\n      1.17 'SPECIFICATIONS' shall mean, with respect to each Product, those\nspecifications and services set forth in a Schedule supplied by BTG U.S. at the\ntime BTG Israel is engaged to manufacture such Product.\n\n      1.18 'TECHNOLOGY' shall mean all the technical information, whether\ntangible or intangible, including (without limitation) any and all data,\ntechniques, discoveries, inventions, processes, know-how, patents (including any\ncontinuation, extension, re-issue or renewal patents), patent applications,\ninventor certificates, trade secrets, methods of production and other\nproprietary information, that BTG U.S. has rights to (as either owner, licensee\nor sublicensee), or may hereafter obtain rights to, relating to the Products.\n\n      1.19 'WASTE' shall mean all rejects or waste relating to the manufacture\nof a Batch, including but not limited to rejected, excess or unusable Raw\nMaterials or Product.\n\n      1.20 'WORKING BATCH RECORD' shall mean the record, for each Batch, of the\ncriteria, methodology, manufacturing Process, Specifications and formulae for\nthe Product, which includes the identity and quantities of the Raw Materials and\nother components, as set forth in the Master Batch Record, and serves as the\nofficial documentation of that specific manufacturing process as it was\nperformed.\n\n\n                 ARTICLE II - SUPPLY AND PROCESSING OF MATERIALS\n\n      2.1   BTG ISRAEL SERVICES\n\n      Upon receipt of a Purchase Order, BTG Israel shall order required Raw\nMaterials and furnish all labor, validated equipment and facilities necessary to\nProcess Product in the amounts set forth in the Purchase Order and BTG Israel\nshall ship the Product in accordance with the terms set forth in such Purchase\nOrder. BTG Israel shall make the Facility and appropriate BTG Israel personnel\navailable in order to comply with the Processing schedule established pursuant\nto written Purchase Orders. Upon completion of Processing, BTG Israel shall\nstore the Product under mutually agreed to conditions after the BTG Israel\nApproval Date.\n\n      For each Batch Processed by BTG Israel, BTG Israel agrees to exercise its\nbest efforts to meet the following Processing schedule:\n\n                                    -4-\n\n\n\n\n\n\n            1. BTG Israel will ship test samples of quantities of Product\n      specified by BTG U.S. to BTG U.S. within 3 working days of the completion\n      of each lot if required by BTG U.S. Shipment will be via overnight courier\n      in accordance with specified shipping instructions set forth in the\n      Purchase Order.\n\n            2. BTG Israel will quality inspect and endeavor to release Product\n      within thirty (30) calendar days of the completion of Processing.\n\n            3. BTG Israel quality control will review and, if requested by BTG\n      U.S., release via overnight courier the Working Batch Record to BTG U.S.\n      within 3 days from final Approval Date.\n\n            4. BTG Israel will have Product available for shipment to BTG U.S.\n      or BTG U.S.'s designated destination within 2 calendar days following BTG\n      U.S.'s quality control review and lot release notification.\n\n            5. BTG Israel shall Process as close as possible to the schedule\n      established pursuant to this Section 2.1. Notification of any necessary\n      schedule change or delay will be forwarded via facsimile to BTG U.S.,\n      attention: Vice President-Manufacturing.\n\n      BTG Israel may, without the consent of BTG U.S., arrange for any Product\nto be formulated, vialed, labelled and packaged by an Affiliate of BTG Israel,\nor, with the consent of BTG U.S., such consent not to be unreasonably withheld,\nby a third party under a contract with BTG Israel, in either case at facilities\nwhich comply with current good manufacturing practices as established by the\napplicable Regulatory Authorities in the countries in which such Product is\napproved for commercial sale; provided that nothing herein shall be construed to\ndiminish or limit BTG Israel's responsibilities to fulfill its obligations\nhereunder.\n\n      BTG Israel shall, at BTG U.S.'s request, cause the Product to be labelled\nand packaged in accordance with the applicable requirements of the appropriate\nRegulatory Authorities of each country and BTG U.S.'s reasonable instructions.\n\n      Nothing in this Agreement shall preclude BTG Israel from performing\nmanufacturing services for third parties other than BTG U.S.\n\n      2.2   FORECASTS\n\n      On the first day of each calendar quarter, BTG U.S. will provide BTG\nIsrael with a written rolling forecast of the quantities of each Product that\nBTG U.S. requires for the coming four calendar quarters (not including the\ncalendar quarter beginning on such date), which forecast may be the forecast\nprovided to BTG U.S. by any licensee or distributor of BTG U.S. Products. The\nfirst \n\n\n                                    -5-\n\n\n\n\ncalendar quarter of each rolling forecast may not be changed except pursuant to\nSection 2.4 or with BTG Israel's prior consent, and shall be used by BTG Israel,\namong other things, to determine the quantities of Raw Materials required to\nprepare for manufacturing each Product. BTG Israel will promptly notify BTG U.S.\nif it will be unable to manufacture any Product in accordance with any written\nrolling forecast provided to BTG Israel pursuant to this Section 2.2.\n\n      2.3   PURCHASE ORDERS\n\n      All Purchase Orders shall be provided to BTG Israel at least two months\nprior to the start date of the first calendar quarter of forecasted manufacture\nfor the Product set forth in the BTG Israel manufacturing schedule.\n\n      The quantities indicated will be no more than ten (10) percent above the\nforecast for such calendar quarter or an additional Batch of Product, whichever\nis greater, provided Raw Materials are available. BTG Israel will use its\nreasonable and diligent efforts, but will be under no obligation, to supply\nProduct in excess of such amount. If BTG U.S. requests reduced production less\nthan one month prior to the scheduled start of production, BTG Israel shall make\nevery reasonable effort to reschedule replacement production to fill the\ncapacity left open by the reduced BTG U.S. production. If BTG Israel is not able\nto schedule replacement production, BTG U.S. shall be obligated to pay BTG\nIsrael fifty (50) percent of the Processing Fee which would otherwise be payable\nfor the manufacturing that is not undertaken as scheduled pursuant to the\nPurchase Order. If there is a conflict between this Agreement and the Purchase\nOrder, this Agreement shall take precedence.\n\n      2.4   RAW MATERIALS\n\n            2.4.1 SUPPLY OF RAW MATERIALS\n\n            For administrative convenience, BTG Israel will order the Raw\nMaterials required to Process the Products. BTG Israel will order Raw Materials\nfrom vendors specified on Exhibit A and any other high quality vendors chosen by\nBTG Israel and reasonably acceptable to BTG U.S.; provided, however, that if BTG\nIsrael proposes to use a vendor not specified on Exhibit A, it shall notify BTG\nU.S., and such vendor shall be deemed acceptable to BTG U.S. unless, within 10\ndays of such notice, BTG U.S. notifies BTG Israel that such vendor is not\nacceptable. All shipments of Raw Materials shall be accompanied by a vendor's\nCertificate of Analysis confirming that, at the time of shipment to BTG Israel\nfor Processing, the Raw Materials meet all applicable Specifications. The vendor\nwill be required to warrant that the Raw Materials have been produced in\ncompliance with applicable laws and regulations, including without limitation,\nthe current Good Manufacturing Practices Regulations of the FDA ('CGMPS') in\neffect at the time of Processing. BTG Israel shall store the Raw Materials from\ntime of receipt under appropriate room temperature conditions until use, in\naccordance with all applicable regulatory requirements and cGMP guidelines and\nthe Specifications.\n\n                                       -6-\n\n\n\n\n\n\n\n            2.4.2 VERIFICATION BY BTG ISRAEL\n\n            BTG Israel shall verify the quantity and identity of all Raw\nMaterials according to BTG U.S. approved methods and procedures and shall\ninspect all Raw Materials in accordance with BTG Israel's written incoming\ninspection procedures. BTG Israel shall inform the vendor of any discrepancies\nin quantity and identity testing of the Raw Materials discovered by BTG Israel\nwithin five (5) working days after receipt of the Raw Materials. BTG Israel\nshall confirm receipt of Raw Materials immediately upon receipt and shall also\ninform the vendor of any damage to the Raw Materials received (e.g., damaged or\npunctured containers) which is visually obvious immediately upon receipt or when\ndiscovered, and will file the appropriate claims with the shipping company\nwithin the required notice period. Rejected Raw Materials will be returned to\nthe vendor at vendor's expense and direction or disposed of at vendor's expense\nand direction.\n\n      2.5   WASTE DISPOSAL\n\n      Based upon instructions from BTG U.S., BTG Israel shall hire, direct and\npay for a qualified waste contractor to remove, in accordance with established\nenvironmental and other regulatory regulations, all BTG U.S. Waste from BTG\nIsrael's Facility. All costs incurred pursuant to this section shall be charged\nto and paid for by BTG U.S. Disposal of Waste generated as a result of BTG\nIsrael's negligence shall be disposed of and paid for by BTG Israel. BTG Israel\nshall obtain and maintain all waste generator licenses, disposal manifests and\nother records, which shall be provided to BTG U.S. upon BTG U.S.'s written\nrequest. BTG Israel will segregate, or keep records to account for, Waste\narising from the Processing of Product from waste generated on behalf of other\nBTG Israel clients.\n\n\n                        ARTICLE III - DELIVERY AND TITLE\n\n      3.1 BTG Israel shall ship the Product at BTG U.S.'s expense and in\naccordance with BTG U.S.'s written instructions, FOB BTG Israel's Facility. For\npurposes of this Agreement, delivery of Product by BTG Israel to BTG U.S. shall\nbe deemed to have taken place upon delivery to a BTG U.S.-designated carrier at\nBTG Israel's Facility.\n\n      3.2 Title to all work in process to produce Product, and all completed\nProduct, shall at all times remain in BTG U.S. BTG Israel shall assume liability\nfor, and defend, indemnify and hold BTG U.S., its employees, agents, officers\nand directors harmless from and against any loss or damage relating to the Raw\nMaterials, the work in process to produce Product and completed Product arising\nfrom BTG Israel's negligence or willful misconduct while BTG Israel has custody\nand control over the Raw Materials, work in process to produce the Product\nand\/or the completed Product.\n\n\n                                    -7-\n\n\n\n\n\n\n      3.3 After the BTG Israel Approval Date, BTG Israel shall send all complete\nand approved Working Batch Records to BTG U.S. BTG U.S. has sixty (60) days from\nreceipt of such records to accept or reject the Product. Upon such receipt, BTG\nU.S. may reject Product on a Batch-by-Batch basis only (i) in the event such\nBatch of Product fails to meet the Specifications as set forth in Exhibit B, and\n(ii) by giving written notice of rejection to BTG Israel within sixty (60) days\nfollowing receipt by BTG U.S. of the Master Batch Records. The failure of BTG\nU.S. to reject Product in the manner set forth above shall constitute acceptance\nthereof. Acceptance of a Batch by BTG U.S. shall be deemed final disposition,\nand a subsequent rejection of the Batch by BTG U.S. shall not be allowed.\n\n      3.4 (a) Any claim by BTG U.S. submitted to BTG Israel pursuant to Section\n3.3 shall be accompanied by a report of analysis (including an adequate Product\nsample from the Batch analyzed), and shall be handled as hereafter set forth in\nthis Section 3.4.\n\n          (b) Should BTG U.S. reject any Batch pursuant to Section 3.3, and\nBTG Israel agrees that such rejection was justified, BTG Israel shall promptly\ncredit BTG U.S.'s account for the Processing Fee paid pursuant to Section 4.1.\n\n          (c) Should BTG U.S. reject any Batch pursuant to Section 3.3, and\nshould BTG Israel, after good faith negotiation, fail to agree that such\nrejection was justified, the Parties shall each appoint an independent third\nparty and these two shall select a qualified third to test samples of such Batch\nand to review records and test data and other relevant information developed by\nboth Parties relating thereto to ascertain liability for the breach. The\nfindings of such third party shall be binding upon both Parties. If the Product\nis found to meet BTG U.S.'s specifications in all material respects, including\nprocessing in conformance with cGMPs and Master Batch Records, BTG U.S. shall\npay the costs of such tests and shall be deemed to have accepted the Product. If\nthe Product is not found to meet Specifications or Master Batch Records in all\nmaterial respects, BTG Israel shall pay the costs of such tests and shall\npromptly credit BTG U.S.'s account for the Processing Fee paid pursuant to\nSection 4.1.\n\n\n                    ARTICLE IV - PROCESSING FEE AND PAYMENT\n\n      4.1 The Processing Fee payable to BTG Israel for Processing each Batch of\nBTG U.S.'s Product is specified as follows:\n\n            4.1.1 The Raw Materials that are ordered by BTG Israel are not part\nof the Processing Fee. Raw Materials purchased by BTG Israel and used in the\nProcessing of each Batch will be invoiced separately at cost, and shall be\nfurnished to BTG U.S. on a complete cost breakdown. BTG Israel will forward\noriginals of receiving documents to BTG U.S. and will provide BTG U.S. such\nquality control documentation that accurately tracks all accepted and\/or\nrejected materials so that BTG U.S. may track the associated invoices and\/or\ncredits from the supplying \n\n\n                                    -8-\n\n\n\n\n\n\nvendor. BTG Israel shall invoice BTG U.S. for the Raw Materials used in each\nBatch following completion of Processing of each Batch, and shall detail the\nquantity of each Raw Material used. All invoices shall be due and payable within\nthirty (30) calendar days after receipt of the invoice by BTG U.S.\n\n            4.1.2 The price per Batch for Processing each Product will be BTG\nIsrael's Cost of Manufacturing such Product plus the Margin.\n\n      4.2 BTG Israel shall invoice BTG U.S. for the full Processing Fee after\nthe BTG Israel Approval Date. All invoices shall be due and payable within\nthirty (30) calendar days after receipt of the invoice by BTG U.S. If BTG U.S.\ndisagrees for any reason with the amount of an invoice submitted by BTG Israel,\nBTG U.S. shall notify BTG Israel in writing of such disagreement within thirty\n(30) calendar days of receipt of such invoice, and the Parties shall promptly\nattempt to resolve the difference. BTG Israel shall reference BTG U.S.'s\nPurchase Order on all invoices.\n\n      4.3 BTG U.S. shall reimburse BTG Israel for all actual costs incurred by\nBTG Israel in having the Product formulated, vialed, packaged and labelled by a\nthird-party. BTG Israel shall invoice BTG U.S. following receipt of an invoice\nfrom such third-party, and shall include a copy of such third-party's invoice.\nAll invoices shall be due and payable within thirty (30) calendar days after\nreceipt of the invoice by BTG U.S.\n\n      4.4 BTG Israel shall keep full and true books of account and other records\nin sufficient detail so that the Processing Fee payable to BTG Israel hereunder\ncan be properly ascertained. BTG Israel agrees, at the request of and expense of\nBTG U.S., to permit an independent certified public accountant selected by BTG\nU.S. (except one to whom BTG Israel has some reasonable objection) to have\naccess, during ordinary business hours, to such books and records as may be\nnecessary to determine in respect of invoices for Product delivered not more\nthan two (2) years prior to the date of such request the correctness of any\ndetermination of the Processing Fee for the Product contained in such invoice,\nbut in no event shall any invoice be subject to such accountant's determination\nmore than once. The basis for any determination of such accountant shall be made\navailable for review and comment by BTG Israel and reconsidered if BTG Israel so\nrequests, and if the parties do not agree as to the determination of such\nProcessing Fee, a further determination shall be made at BTG Israel's expense by\nanother internationally recognized independent certified public accountant\nselected by BTG U.S. from among three proposed by BTG Israel and such accountant\nshall make a final determination. Such final determination shall be binding upon\nthe parties hereto. Such accountant shall not disclose to BTG U.S. any\ninformation relating to the business of BTG Israel except that which should\nproperly have been contained in any invoice or other report required hereunder.\n\n\n                                    -9-\n\n\n\n\n\n\n\n                            ARTICLE V - LICENSE GRANT\n\n      5.1 BTG U.S. hereby grants to BTG Israel, with the right to sublicense\npursuant to Section 2.1 hereof, a non-exclusive worldwide royalty-free license\nto use the Technology solely in connection with the performance of its\nobligations hereunder.\n\n                       ARTICLE VI - TERMS AND CONDITIONS\n\n      6.1 BTG Israel shall perform services under this Agreement in compliance\nwith current Good Manufacturing Practices and follow the BTG Israel standard\noperating procedures in effect as of the date of this Agreement, and any written\nrevisions as may later be required by BTG U.S. and agreed to by BTG Israel. BTG\nIsrael shall not implement any changes, material or otherwise, relating to any\nProduct or its Process procedures without first obtaining the written approval\nof BTG U.S., which approval shall not be unreasonably withheld. A change is\ndefined as any variation in the written procedures currently in place that (a)\nimpacts the regulatory commitments for the Product, (b) may require\nrevalidation, (c) may affect the quality, purity, identity or strength of the\nRaw Materials or Product, or (d) would necessarily result in changing, altering\nor modifying the BTG U.S. or BTG Israel Specifications, test methods, sampling\nprocedures, validation procedures or Master Batch Record relating to the\nProduct.\n\n      6.2 BTG U.S. will inform BTG Israel in writing of any modifications to the\nSpecifications; the relevant documents and related schedules to this Agreement\nwill be revised accordingly without requiring any formal mutual amendment. Upon\nwritten acceptance of said modifications, BTG Israel shall immediately implement\nthe modified documents and procedures pertinent to the modified Specifications.\nSimilarly, BTG Israel shall advise BTG U.S. in writing of any proposed or\nrequired changes in procedures prior to their implementation.\n\n      6.3 BTG Israel warrants that each Product shall be Processed in accordance\nwith the Specifications for such Product and shall be Processed in accordance\nwith applicable regulations of the FDA and applicable Regulatory Authorities in\nthe other countries in which such Product is approved for commercial sale\npertaining to cGMPs and in accordance with the Drug Master File (DMF) pertaining\nto the BTG Israel Facility. BTG Israel shall provide to BTG U.S. such\ninformation as BTG U.S. may require with respect to the Facility and the Process\nin connection with BTG U.S. or its licensees or distributors obtaining\nregulatory approval for commercial sale of the Products.\n\n      6.4 BTG Israel shall permit BTG U.S. representatives to enter BTG Israel's\nFacility upon reasonable notice and at reasonable intervals during regular\nbusiness hours for the purpose of making quality control inspections of the\nfacilities used in manufacturing, receiving, sampling, analyzing, storing,\nhandling, packaging, shipping and disposing of the Raw Materials, Product and\nWaste relative to BTG U.S.'s Product as BTG U.S. may reasonably request. BTG\nU.S. shall also have the \n\n\n                                    -10-\n\n\n\n\n\nright to have suitable representatives present in BTG Israel's plant to observe\nthe Processing of the Product, storing, shipping and disposal processes relevant\nto BTG U.S.'s Product.\n\n      6.5 BTG Israel shall have primary responsibility for adopting and\nenforcing safety procedures for the handling and production of the Raw\nMaterials, compounded bulk and Product that comply in all material respects with\nall environmental and occupational safety and health requirements and any other\napplicable regulatory requirements. Such responsibilities shall terminate as to\nProduct upon delivery to a BTG U.S.-designated carrier pursuant to Section 3.1\nand as to Waste upon delivery thereof to the approved waste contractor pursuant\nto Section 2.5.\n\n\n                    ARTICLE VII - CONFIDENTIAL INFORMATION\n\n      7.1 Except to the extent expressly authorized by this Agreement, during\nthe term of this Agreement and following the expiration or termination of this\nAgreement, neither Party shall:\n\n            (a) Disclose, publish or make available any Proprietary Information\n      disclosed to it by the other to any third party, including employees who\n      do not need to know or have access to such Proprietary Information.\n\n            (b) Sell, transfer or otherwise use or exploit any such Proprietary\n      Information disclosed to it by the other Party.\n\n            (c) Knowingly permit the sale, transfer, use or exploitation by a\n      third party of any such Proprietary Information disclosed to it by the\n      other Party which may have been disclosed to such third party, including\n      employees who do not need to know or have access to such Proprietary\n      Information.\n\n      7.2 During the term of this Agreement, neither Party shall make any press\nrelease or other disclosure of the terms of this Agreement without the prior\nwritten consent of the other Party, except as required by a court of competent\njurisdiction and pursuant to the disclosure requirements of Regulatory\nAuthorities, including the Securities and Exchange Commission.\n\n      7.3 Notwithstanding the provisions of Section 7.1 hereof, BTG Israel and\nBTG U.S. may, to the extent necessary, disclose and use Proprietary Information\n(a) for the purpose of securing institutional or government approval to\nclinically test or market any Product, (b) to the extent necessary or useful to\ncommercialize any Product if such Proprietary Information is disclosed in a\nmanner that preserves the confidentiality thereof upon terms reasonably\nequivalent to those set forth herein; provided, however, that in each such\ninstance any such disclosure shall be made to persons which either have agreed\nto be bound by or are already subject to a duty of confidentiality, for the\nbenefit of a party hereto, substantially the same as that set forth in Section\n7.1 hereof, wherever reasonably possible.\n\n\n                                    -11-\n\n\n\n\n\n\n\n                 ARTICLE VIII - INDEMNIFICATION AND INSURANCE\n\n      8.1 BTG U.S. shall defend, indemnify and hold harmless BTG Israel, its\nofficers, agents, employees and Affiliates from any loss, claim, action, damage,\nexpense or liability (including defense costs and attorneys' fees) ('CLAIM')\nincluding, but not limited to, the costs for environmental sampling, cleanup and\nremediation, arising out of BTG Israel's disposal of BTG U.S.'s Waste in\naccordance with this Agreement, or the breach of any representation or warranty\nmade by BTG U.S. herein or the handling, possession or use of the Product\nfollowing delivery to a common carrier pursuant to Section 3.1, except to the\nextent that the Claim is based on, arises out of, or is due to the negligence or\nmisconduct of, or breach of this Agreement by, BTG Israel or its officers,\nagents, employees or Affiliates.\n\n      8.2 BTG Israel shall defend, indemnify and hold harmless BTG U.S., its\nofficers, agents, employees and Affiliates from any Claim, including, but not\nlimited to, the costs for environmental sampling, cleanup and remediation,\narising out of or related to the breach of any representation or warranty made\nby BTG Israel herein, BTG Israel's negligence or misconduct, or the failure to\nProcess the Product in accordance with the Specifications, except to the extent\nthat the Claim is based on, arises out of, or is due to the negligence or\nmisconduct of, or breach of this Agreement by, BTG U.S. or its officers, agents,\nemployees or Affiliates.\n\n      8.3 In any case under this Agreement where one Party has indemnified the\nother against any Claim or legal action, indemnification shall be conditioned on\ncompliance with the procedure outlined below. Provided that prompt notice is\ngiven of any Claim or suit for which indemnification might be claimed, the\nindemnifying Party will defend, contest or otherwise protect any such Claim or\nsuit at its own cost and expense. The indemnified Party may, but will not be\nobligated to, participate at its own expense in a defense thereof by counsel of\nits own choosing, but the indemnifying Party shall be entitled to control the\ndefense unless the indemnified Party has relieved the indemnifying Party from\nliability with respect to the particular Claim. If the indemnifying Party fails\nto timely defend, contest or otherwise protect against any such Claim or suit,\nthe indemnified Party may, but will not be obligated to, defend, contest or\notherwise protect against the same, and make any compromise or settlement\nthereof and recover the entire costs thereof from the indemnifying Party,\nincluding reasonable attorneys' fees, disbursements and all amounts paid as a\nresult of such Claim or suit or the compromise or settlement thereof; provided,\nhowever, that if the indemnifying Party undertakes the timely defense of such\nClaim or suit, the indemnified Party shall not be entitled to recover from the\nindemnifying Party for its costs incurred in the defense thereof. The\nindemnified Party shall cooperate and provide such assistance as the\nindemnifying Party may reasonably request in connection with the defense of the\nmatter subject to indemnification.\n\n      8.4 BTG U.S. and BTG Israel each represent that they are sufficiently\nself-insured or insured against any liability arising under this Article VIII.\n\n\n                                    -12-\n\n\n\n\n\n\n\n                             ARTICLE IX - RECALLS\n\n\n      9.1 If any Raw Materials or Product must be recalled by reason of failure\nto meet any applicable Specifications, requirements of the FDA or any other\napplicable Regulatory Authority or any other requirements of law, BTG U.S. shall\nhave the sole responsibility to effect the recall. BTG Israel shall cooperate as\nreasonably required in BTG U.S.'s efforts, and shall notify BTG U.S. if it is\ndetermined by BTG Israel that such a recall is warranted based on BTG Israel's\nquality control findings.\n\n      9.2 BTG U.S. shall reimburse BTG Israel for any costs reasonably expended\nby BTG Israel to effect the recall.\n\n\n                        ARTICLE X - RECORDS AND AUDITS\n\n      10.1 During the term of this Agreement and for seven (7) years after the\nexpiration date of any particular Batch of Product manufactured by BTG Israel\nfor BTG U.S., BTG Israel shall maintain records and samples relating to such\nBatch(es) sufficient to substantiate and verify its duties and obligations\nhereunder, including but not limited to records of orders received, Raw\nMaterials provided, Product manufactured, work in progress, validation reports,\nProcessing analyses and quality control tests, disposal of Waste, and the like.\n\n      10.2 BTG U.S. shall be responsible for all obligations under the\nregulations of all applicable Regulatory Authorities, except for routine\nstability testing and sample retention. Stability testing shall be included in\nthe Cost of Manufacturing. BTG U.S. shall immediately inform BTG Israel of all\nFDA or other regulatory audits pertinent to BTG U.S.'s Raw Materials, Product or\nSpecifications. BTG U.S. shall inform BTG Israel in advance of planned FDA or\nother regulatory audits as soon as the schedule therefor is known. BTG U.S.\nshall provide BTG Israel with copies of any regulatory letters or other\ndocuments issued by the FDA or other Regulatory Authorities in connection with\nthe audit or inspection within five (5) days of BTG U.S.'s receipt of such a\ndocument.\n\n      10.3 BTG Israel shall allow BTG U.S. representatives, upon reasonable\nnotice and at reasonable intervals during normal business hours, to enter BTG\nIsrael's plant for the purpose of taking inventories. BTG Israel shall further\nallow BTG U.S. representatives, upon reasonable notice and at such intervals as\nmay be reasonably necessary, to examine and copy the records referenced in\nSection 10.1 during normal business hours for product liability, regulatory and\nquality control purposes.\n\n\n                                    -13-\n\n\n\n\n                        ARTICLE XI - TERM AND TERMINATION\n\n      11.1 Subject to the termination provisions of Section 11.2, the initial\nterm of this Agreement shall commence as of January 1, 1996 ('EFFECTIVE DATE')\nand end on December 31, 2000, and shall thereafter be automatically renewed for\nsuccessive one (1) year terms and shall continue in full force and effect until\nterminated by either Party by written notice to the other at least nine (9)\nmonths before the end of the initial term or on nine (9) months' written notice\nthereafter.\n\n      11.2 In addition to each Party's right to terminate this Agreement under\nSection 11.1 above, each Party shall have the right to terminate this Agreement\nby giving the other Party written notice only if:\n\n            (a) the other Party fails to perform or violates any material\n      provision of this Agreement in any material respect, and such failure\n      continues unremedied for a period of thirty (30) days after the date the\n      notifying Party gives written notice to the defaulting Party with respect\n      thereto; or\n\n            (b) the other Party is declared insolvent or bankrupt by a court of\n      competent jurisdiction, or a voluntary petition of bankruptcy is filed in\n      any court of competent jurisdiction by the other Party, or the other Party\n      makes or executes any assignment for the benefit of creditors, or a\n      receiver is appointed to control the business of the other Party; or\n\n            (c) the FDA orders that BTG Israel cease Processing Product.\n\nThis Agreement shall terminate immediately upon the giving of notice of\ntermination pursuant to this Section 11.2.\n\n      11.3 The termination of this Agreement shall not operate to relieve BTG\nIsrael from its obligation to Process and deliver all Product ordered through\nfirm Purchase Orders received from BTG U.S. prior to receipt of notice of such\ntermination, unless such termination is effected pursuant to Section 11.2, or of\nBTG U.S.'s obligation to accept delivery of Product and pay for such Processing,\nunless such termination is effected as a result of Section 11.2(c) or a breach\nof this Agreement by BTG Israel pursuant to Section 11.2(a).\n\n\n                           XII - REGULATORY MATTERS\n\n      12.1 BTG U.S. shall be responsible for obtaining FDA or other regulatory\napproval for each Product and shall own the all regulatory approvals. BTG Israel\nagrees to comply with all commitments made in any New Drug Application or\nsimilar filing regarding BTG Israel's manufacturing responsibilities as\ndescribed herein. BTG Israel shall be responsible for the maintenance of the\nDrug Master File covering the BTG Israel Facility.\n\n\n                                    -14-\n\n\n\n\n\n\n\n\n      12.2 The vendors specified by BTG U.S. shall be responsible for ensuring\ncompliance of the Raw Materials with all applicable cGMP standards. BTG U.S.\nshall be responsible for ensuring compliance of the Product Specifications\n(including but not limited to the text of any labeling proposed by BTG U.S.)\nwith all applicable cGMP standards. BTG Israel shall be responsible for\ncompliance of the bulk manufacturing and Processing procedures with the\nSpecifications and cGMP standards. Each Party will provide reasonable assistance\nto the other, at no charge, if necessary to respond to FDA or other regulatory\naudits, inspections, inquiries or requests concerning the Raw Materials or\nProduct.\n\n      12.3 BTG Israel and BTG U.S. shall each give the other prompt notice of\nany information either of them receives regarding the safety of the Raw\nMaterials or Product, including any confirmed or unconfirmed information on\nadverse, serious or unexpected events associated with the use of the Product.\nFor serious or unexpected events, notice must be given by telephone within one\n(1) business day after receipt of the information and followed by written notice\nnot less than one (1) week thereafter. All responsibility, including responses\ndue and cost for filing any reports with the FDA or other Regulatory Authorities\nconcerning such reactions (including Drug Experience Reports) caused by the\nProduct manufactured for BTG U.S. shall be BTG U.S.'s. Further to the above, BTG\nU.S. will be responsible at its cost for handling Product complaints involving\ncommercial goods which contain Product. BTG Israel will provide timely\nassistance in responding to any complaints including reviews of Batch records\nand retained samples as well as testing of Product engendering a complaint if\nrequired, and BTG U.S. will reimburse BTG Israel for reasonable expense incurred\ntherewith. The costs of such testing shall be borne by BTG U.S.; however, if it\nis determined that the Product complaint was directly or indirectly caused by\nBTG Israel's failure to Process the Product in accordance with the\nSpecifications, BTG Israel shall reimburse BTG U.S. for the actual and\nreasonable costs of such testing and other Claims arising therefrom.\n\n\n                    ARTICLE XIII - TRADEMARKS AND LABELING\n\n      13.1 BTG Israel shall not affix to the Product, or any packaging thereof,\nany label, stamp or other mark identifying BTG Israel as the source of the\nProduct except as may be required by applicable laws or regulations.\n\n      13.2 Nothing contained herein shall give BTG Israel any right to use any\nBTG U.S. copyright or trademark, and BTG Israel shall not obtain any right,\ntitle, or interest in any BTG U.S. trademark by virtue of this Agreement or its\nperformance of services hereunder.\n\n\n                     ARTICLE XIV - RELATIONSHIP OF PARTIES\n\n      14.1 It is not the intent of the Parties hereto to form any partnership or\njoint venture. Each Party shall, in relation to its obligations hereunder, act\nas an independent contractor, and nothing in\n\n\n                                    -15-\n\n\n\n\nthis Agreement shall be construed to give such party the power or authority to\nact for, bind or commit the other Party in any way whatsoever.\n\n\n                            ARTICLE XV - WARRANTIES\n\n      15.1 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, BTG ISRAEL\nMAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS\nOR IMPLIED, INCLUDING ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR\nFITNESS FOR A PARTICULAR PURPOSE.\n\n      15.2 OTHER THAN AS EXPRESSLY SET FORTH ELSEWHERE IN THE AGREEMENT, NEITHER\nBTG ISRAEL NOR BTG U.S. SHALL BE LIABLE FOR DIRECT, INDIRECT, SPECIAL,\nINCIDENTAL OR CONSEQUENTIAL DAMAGES (INCLUDING LOSS OF PROFITS) WHETHER BASED ON\nCONTRACT, TORT OR ANY OTHER LEGAL THEORY.\n\n\n                    ARTICLE XVI - ASSIGNMENT AND DELEGATION\n\n      16.1 This Agreement shall be binding upon and inure to the benefit of the\nParties, their successors and permitted assigns. Neither Party may assign this\nAgreement without the prior written consent of the non-assigning Party. Except\nas permitted by Section 2.1 hereof, BTG Israel shall Process all Product at the\nFacility.\n\n\n                         ARTICLE XVII - GOVERNING LAW\n\n      17.1 This Agreement shall be governed by and interpreted in accordance\nwith the laws of the State of New Jersey.\n\n\n                         ARTICLE XVIII - FORCE MAJEURE\n\n      18.1 Neither Party hereto shall be liable to the other in damages for, nor\nshall this Agreement be terminable by reason of, any delay or default in such\nParty's performance hereunder, if such delay or default is caused by conditions\nbeyond such Party's control including, but not limited to, acts of God, war,\ninsurrection, civil commotion, destruction of production facilities or materials\nby earthquake, fire, flood or storm, labor disturbances including strikes or\nlockouts, epidemic or failure of suppliers, public utilities or common carriers.\n\n\n                                    -16-\n\n\n\n\n\n      18.2 BTG Israel shall have no liability for any loss to Raw Materials or\nProduct stored by BTG Israel pursuant to Article II, unless caused by BTG\nIsrael's negligence.\n\n      18.3 Each Party hereto agrees to promptly notify the other Party of any\nevent of force majeure under Section 18.1 above and to employ all reasonable\nefforts toward prompt resumption of its performance hereunder when possible if\nsuch performance is delayed or interrupted by reason of such event.\n\n\n                             ARTICLE XIX - NOTICES\n\n      19.1 All notices and other communications required or desired to be given\nor sent by one party to the other party shall be in writing, in the English\nlanguage, and shall be deemed to have been given (a) on the date of delivery, if\ndelivered to the persons identified below, (b) five calendar days after mailing\nif mailed, with proper postage, by certified or registered airmail, postage\nprepaid, return receipt requested, addressed as set forth below, (c) on the date\nof receipt if sent by telex or telecopy, and confirmed in writing in the manner\nset forth in (b) on or before the next day after the sending of the telex or\ntelecopy, or (d) two business days after delivered to an internationally\nrecognized overnight courier service marked for overnight delivery, as follows:\n\nTo BTG U.S.:             Bio-Technology General Corp.\n                         70 Wood Avenue South\n                         Iselin, New Jersey  08830\n                         Attention:  President\n                         Telecopier:  908-632-8844\n\nTo BTG Israel:           Bio-Technology General (Israel) Ltd.\n                         Kiryat Weizmann\n                         Rehovot 76326, Israel\n                         Attention:  President\n                         Telecopier:  972-8-9409041\n\n            Any party may change such party's address for notices by notice duly\ngiven pursuant to this Article XIX.\n\n                         ARTICLE XX - ENTIRE AGREEMENT\n\n      20.1 This Agreement constitutes the entire agreement between the parties\nwith respect to the subject matter hereof and supersedes and replaces all prior\nagreements, understandings, writings and discussions between the parties,\nincluding without limitation that certain Manufacturing Services Agreement,\ndated as of January 1, 1995.\n\n\n                                    -17-\n\n\n\n\n\n\n\n\n                            ARTICLE XXI - CAPTIONS\n\n      21.1 The captions in this Agreement are solely for convenience of\nreference and shall not be used for purposes of interpreting or construing the\nprovisions hereof.\n\n\n                          ARTICLE XXII - COUNTERPARTS\n\n      22.1 This Agreement may be executed in one or more counterparts, each of\nwhich shall be deemed to be an original, but all of which together shall\nconstitute one and the same agreement.\n\n\n      IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed\nby their duly authorized representatives, effective on this date first set forth\nabove.\n\n                              BIO-TECHNOLOGY GENERAL CORP.\n\n\n                              By:   \/s\/\n                                 ---------------------------------------\n                              Its:\n                                  ---------------------------------------\n\n\n                              BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.\n\n\n                              By:   \/s\/\n                                 ---------------------------------------\n                              Its:\n                                  ---------------------------------------\n\n\n\n\n                                    -18-\n<\/pre>\n","protected":false},"template":"","meta":{"_acf_changed":false,"_stopmodifiedupdate":true,"_modified_date":"","_cloudinary_featured_overwrite":false},"corporate_contracts_companies":[6900],"corporate_contracts_industries":[9406],"corporate_contracts_types":[9613,9620],"class_list":["post-42516","corporate_contracts","type-corporate_contracts","status-publish","hentry","corporate_contracts_companies-bio-technology-general-corp","corporate_contracts_industries-drugs__botanical","corporate_contracts_types-operations","corporate_contracts_types-operations__services"],"acf":[],"_links":{"self":[{"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts\/42516","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=42516"}],"wp:term":[{"taxonomy":"corporate_contracts_companies","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_companies?post=42516"},{"taxonomy":"corporate_contracts_industries","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_industries?post=42516"},{"taxonomy":"corporate_contracts_types","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_types?post=42516"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}