{"id":42226,"date":"2015-09-17T11:25:58","date_gmt":"2015-09-17T16:25:58","guid":{"rendered":"https:\/\/content.findlaw-admin.com\/ability-legal\/contracts\/uncategorized\/development-and-license-agreement-imclone-systems-inc-and2.html"},"modified":"2015-09-17T11:25:58","modified_gmt":"2015-09-17T16:25:58","slug":"development-and-license-agreement-imclone-systems-inc-and2","status":"publish","type":"corporate_contracts","link":"https:\/\/corporate.findlaw.com\/contracts\/operations\/development-and-license-agreement-imclone-systems-inc-and2.html","title":{"rendered":"Development and License Agreement &#8211; ImClone Systems Inc. and Merck KGaA"},"content":{"rendered":"<pre>[ImClone letterhead]\n\n\n\n\n                                                August 16, 2001\n\nDr. Bernhard Scheuble\nMerck KGaA\nFrankfurter Strasse 250\nD-64293 Darmstadt, Federal Republic of Germany\n\n\nDear Dr. Scheuble:\n\n         We refer to our development and license agreement (the \"Agreement\")\ndated the 14th day of December 1998 pursuant to which Merck KGaA (\"Merck\") was\ngranted certain rights with respect to ImClone Systems Incorporated's\n(\"ImClone\") anti-EGFR antibody C225, all as defined in the Agreement.\n\n         The parties agree that Sections 1, 2 and 7 of this letter agreement\nshall have effect only in the case that ImClone enters into an agreement\ncurrently being negotiated with a third party referred to as \"Belgium\" during\nsuch negotiations including the arranging for the distribution and sale of C225\noutside the Territory and pursuant to ImClone's rights in Japan. Therefore,\nSections 1, 2 and 7 of this letter agreement shall go into effect upon the\nexecution of such agreement only, provided such agreement with \"Belgium\" is\nentered into within 6 months from the execution of this letter agreement,\nwhereby Sections 3, 4, 5 and 6 shall be and remain in full force and effect upon\nexecution of this letter agreement irrespective of the conclusion of such\nagreement by and between ImClone and \"Belgium\".\n\n\n1.       Notwithstanding Sections 2.1, 2.3 and 9.12, but subject to the other\nprovisions of the Agreement, Merck and ImClone will be deemed to immediately,\nupon the effectiveness of this letter agreement, have co-exclusive rights to\ndevelop and market, with the right to sublicense, the Licensed Products and\/or\nAlternative Products in Japan. Notwithstanding Section 2.3, each of Merck and\nImClone may exercise such rights on a unilateral basis as each sees fit. ImClone\nshall cooperate and expedite with Merck's subsidiary in Japan for filing of an\nIND for C225 in Japan by the end of September 2001.\n\n2.       Merck hereby waives its rights set forth in Section 2.4 in their\nentirety.\n\n                                                CONFIDENTIAL TREATMENT REQUESTED\n\n\n3.       For the avoidance of doubt both ImClone and Merck wish to clarify that\nclinical trial supply and commercial supply with C225 and\/or Alternative Product\nfrom ImClone or a third party authorized by ImClone to Merck shall be at the\nFully-Loaded Cost of Goods as defined in Schedule C of the Agreement. No\nhandling charge related to manufacture of clinical trial supply and commercial\nsupply other than that set forth in Schedule C of the Agreement, if any, shall\nbe applied. As per Schedule C, finished goods warehousing, shipping and other \ndistribution costs incurred by Merck are all included in distribution costs and\nwill be borne by Merck separately from the Fully-Loaded Cost of Goods.\n\n4.       For greater certainty, ImClone hereby agrees that\n\n         (a) Merck shall be entitled, without further compensation to be paid by\nMerck to ImClone (other than in connection with the technology transfer and\ndesign and construction assistance as set forth below) to manufacture for supply\nin its Territory C225 and\/or Alternative Product in one or more manufacturing\nfacilities owned and operated by it, and it is Merck's intent to build such\nfacility or facilities to supply C225 for its Territory, and\n\n         (b) Merck shall be entitled to contract with one or more third parties\nreasonably acceptable to ImClone for the manufacture of C225 and\/or Alternative\nProduct, and it is Merck's intent to so contract with one or more such third\nparties to supply C225 for its Territory. Medarex, Inc. is an acceptable third\nparty to ImClone.\n\nImClone shall in the case of (a) above transfer to Merck, and in the case of (b)\nabove transfer to any such acceptable third party, all technology and know how\nnecessary for such manufacture of C225 and\/or Alternative Product, including\nwithout limitation Licensed Product Technology, the cell lines and appropriate\ndocumentation. Except for reasonable and customary fees to be agreed upon by and\nbetween ImClone and Merck in good faith for the services and documentation\nprovided by ImClone, exemplary elements of which are set forth in Exhibit A\nattached to this letter agreement, such transfer to Merck in the case of (a), or\nto a third party in the case of (b), shall be effected without any additional\npayments to ImClone. In particular the transfer of the cell lines shall be free\nof charge. Upon the termination of any such supply under (a) or (b), all\nappropriate materials and documentation, including but not limited to the cell\nlines, shall be returned to ImClone. Ownership of all such materials and\ndocumentation shall remain at all times with ImClone.\n\n5.       ImClone, upon the execution of this letter agreement unconditionally\nand forever releases and discharges Merck from its obligation set forth in\nSection 4.9 (b) of the Agreement, and unconditionally waives all of its rights\nagainst Merck that might result or might have resulted, directly or indirectly,\nfrom such obligation.\n\n6.       Further, both ImClone and Merck agree to waive in its entirety each\nparty's termination right pursuant to Section 4.9 (c) of the Agreement.\n\n                                                CONFIDENTIAL TREATMENT REQUESTED\n\n\n7.       In consideration of Merck's waiver set forth herein, the royalties to\nbe paid by Merck to ImClone pursuant to Section 4.2 of the Agreement for\nLicensed Products sold by Merck in the Territory shall be, upon the\neffectiveness of this letter agreement, reduced as follows:\n\n(a) The royalties to be paid by Merck pursuant to Section 4.2 (a) shall be\nreduced to ** of ** of Licensed Products; and\n\n(b) the royalties to be paid by Merck pursuant to Section 4.2 (b) shall be in\neach and every year (i) for sales of Licensed Products up to ** of ** reduced to\n** of ** of Licensed Products, and (ii) for sales of Licensed Products exceeding\n** of ** but no greater than ** reduced to ** of ** of Licensed Products for\nsuch part of the **, and (iii) for sales of Licensed Products exceeding ** of **\nremain unchanged (i.e. ** of ** of Licensed Products) for such part of the **.\n\n\n         Initially capitalized terms used in this letter agreement and not\notherwise defined shall have the meaning specified in the agreement.\n\n\n                                                        Very truly yours,\n\n\n                                                        \/s\/ Samuel D. Waksal\n                                                        --------------------\n                                                        Dr. Samuel D. Waksal\n                                                        President and CEO\nACCEPTED AND AGREED:\n\nMerck KGaA\nBy: \/s\/ Klaus-Peter Brandis      \/s\/ Jens Eckhardt\n---------------------------      -----------------\nName: Brandis                    Eckhardt\nTitle: Director                  Legal Counsel\n\n\n\n\n\n\nExhibits:\n\nExhibit A: Exemplary elements of the technology transfer as referred to in\nSection 4\n\n                                                CONFIDENTIAL TREATMENT REQUESTED\n\n\n                                    EXHIBIT A\n\n\n\n                  to the letter agreement dated August 16, 2001\n\n                                 by and between\n\n                          ImClone Systems Incorporated\n\n                                       and\n\n                                   Merck KGaA\n\n\nExemplary elements of technology transfer and know-how for manufacture, as\nreferred to in Paragraph 4 of the letter agreement:\n\n\n1. Design, engineering drawings, process simulation, and equipment lists and\nspecifications for the plant (including, without limitation, piping and\ninstrument drawings).\n\n2. The CMC section of the BLA . This section of the BLA contains manufacturing\ninstructions, batch records, product specifications, product characterization,\nvalidation information and reports, and process history.\n\n3. Validation reports for the clearance and inactivation of viruses from the\nmanufacturing process.\n\n4. Clearance of Process Related Contaminants such as BSA, transferrin, insulin,\nand protein A.\n\n5. Formulation of C225 and\/or Alternative Product with Tween 80 to yield a\nParticulate Free product.\n\n6. Stability reports for API and Product.\n\n7. Validation of Column Reuse for at least one year worth of manufacturing C225\nand\/or Alternative Product.\n\n8. Manufacturing Process Limits Validation for Cell Culture and Downstream\nProcessing.\n\n9. Validation of Process Intermediates Hold times.\n\n                                                CONFIDENTIAL TREATMENT REQUESTED\n\n\n10. Validation Report for the Aseptic Processing of the Filled Product.\n\n11. Validation Study Reports for Shipping Bulk and Filled Products.\n\n12. Validation Study Reports for Container Closure Systems for Bulk and Filled\nProducts.\n\n13. Analytical\/QC support for release testing of API for Merck's CMO(contract\nmanufacturing organization). This may require additional head count at ImClone\nto support the added burden on the QC laboratories.\n\n14. Quality Assurance agreement that defines ImClone's role and obligations for\nQuality support.\n\n15. Tech Transfer and Know-How support over and above that which can be derived\nfrom manufacturing instructions and the batch records contained in the CMC.\n\n16. Transfer of necessary cell bank vials. Eventually, Merck and CMO will need\ntheir own or for ImClone to create one.\n\n17. Product Comparability Reports comparing Lonza vs ImClone. There will need to\nbe a Comparability Protocol written, executed, and data collected to compare\nLonza vs ImClone vs Merck CMO.\n\n18. Process Consistency Reports.\n\n19. Vendor Specifications and Supplier information to set-up CMO.\n\n20. Improvements made, and made in the future, to the manufacturing process.\n\n<\/pre>\n","protected":false},"template":"","meta":{"_acf_changed":false,"_stopmodifiedupdate":true,"_modified_date":"","_cloudinary_featured_overwrite":false},"corporate_contracts_companies":[7835],"corporate_contracts_industries":[9405],"corporate_contracts_types":[9613,9616],"class_list":["post-42226","corporate_contracts","type-corporate_contracts","status-publish","hentry","corporate_contracts_companies-imclone-inc","corporate_contracts_industries-drugs__biotech","corporate_contracts_types-operations","corporate_contracts_types-operations__ip"],"acf":[],"_links":{"self":[{"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts\/42226","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=42226"}],"wp:term":[{"taxonomy":"corporate_contracts_companies","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_companies?post=42226"},{"taxonomy":"corporate_contracts_industries","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_industries?post=42226"},{"taxonomy":"corporate_contracts_types","embeddable":true,"href":"https:\/\/corporate.findlaw.com\/legal-api\/wp-json\/wp\/v2\/corporate_contracts_types?post=42226"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}