TRU-015 for the Treatment of Rheumatoid Arthritis. Rheumatoid arthritis, or RA, is estimated to affect between 2 and 2.5 million people in the United States, with approximately 100,000 new cases diagnosed each year. It is estimated that approximately 4.3 million people are affected by RA in the United States, Japan and Europe. Total worldwide sales of protein therapeutics used for the treatment of RA were $7.6 billion in 2005 and are expected to grow to $10 billion in 2010
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EX-10.15 18 v18917orexv10w15.txt EXHIBIT 10.15 Exhibit 10.15 AMENDMENT No. 2 to THE DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT Dated 12 AUGUST 2003 Between LONZA BIOLOGICS *** and TRUBION PHARMACEUTICALS, INC. (formerly known as GENECRAFT INC.) Schedule 1 - Definitions and Specifications Definition of term "Product" Schedule 2 - Services New Stages Schedule 3 - Price and Payment Price and Payment for New Stages THIS SECOND AMENDMENT ("Second Amendment") is made the 2nd day of December, 2003 BETWEEN LONZA BIOLOGICS *** (hereinafter referred to as "LB"), and TRUBION PHARMACEUTICALS, INC. (formerly known as GENECRAFT, INC.) of 2401 4th Avenue, Suite 1050, Seattle, WA 98121, USA (herein after referred to as the "Customer") WHEREAS A. LB and the Customer entered into a development and manufacturing services agreement dated 12 August 2003 pursuant to which LB agreed to provide Services to the Customer (as amended by the Amendment No. 1 between the parties dated November 7, 2003, "the Agreement"), and, B. The Customer now wishes LB to perform additional Services under the Agreement, and, C. LB is willing to perform such additional Services on the terms to be agreed upon by the parties and incorporated into the Agreement, and D. The parties wish to amend the Agreement in accordance with Clause 12.5 thereto. NOW THEREFORE IT IS HEREBY AGREED as follows: 1 SCHEDULE 1 SHALL BE AMENDED AS FOLLOWS: The definition of the term "Product" shall be amended to read in its entirety as follows: "Product" shall mean the Small Modular ImmunoPharmaceutical (SMIP) produced by the ***, which targets and binds to human CD20." 2 SCHEDULE 2 SHALL BE AMENDED TO ADD THE FOLLOWING STAGES: Stage 4 -***; Stage 5 -***; and Stage 6 -***. ALL ADDITIONAL SERVICES DESCRIBED IN THIS SECOND AMENDMENT WILL BE PERFORMED ON TIMESCALES TO BE AGREED UPON BY THE PARTIES. 3 SCHEDULE 3 TO THE AGREEMENT SHALL BE AMENDED TO INCLUDE PROVISION FOR PAYMENT FOR THE ABOVE MENTIONED ADDITIONAL SERVICES, ON TERMS TO BE AGREED BETWEEN THE PARTIES. 4 LB HEREBY REPRESENTS AND WARRANTS THAT, AS OF THE EFFECTIVE DATE OF THIS SECOND AMENDMENT, IT IS NOT A PARTY TO ANY AGREEMENT THAT WOULD PREVENT IT FROM PERFORMING THE ADDITIONAL SERVICES DESCRIBED IN THIS SECOND AMENDMENT OR OTHERWISE FULFILLING ITS OBLIGATIONS UNDER THIS SECOND AMENDMENT, AND LB HEREBY COVENANTS THAT IT SHALL NOT ENTER INTO ANY SUCH CONFLICTING AGREEMENT DURING THE TERM OF THE AGREEMENT, AS AMENDED BY THIS SECOND AMENDMENT. 5 THE PARTIES SHALL ENTER GOOD FAITH NEGOTIATIONS TO AMEND THE AGREEMENT TO INCLUDE THE TERMS AND CONDITIONS THAT WILL GOVERN AND APPLY TO THE ADDITIONAL SERVICES TO BE PERFORMED BY LONZA UNDER THIS SECOND AMENDMENT. SHOULD SUCH GOOD FAITH NEGOTIATIONS FAIL, NEITHER PARTY SHALL HAVE ANY OBLIGATION WITH RESPECT TO SUCH ADDITIONAL SERVICES. 6 THE PARTIES AGREE THAT THIS AMENDMENT SHALL BECOME EFFECTIVE UPON THE EXCHANGE OF SIGNATURE COPIES BY FACSIMILE TRANSMISSION. 7 SAVE AS HEREIN PROVIDED ALL OTHER TERMS AND CONDITIONS OF THE AGREEMENT SHALL REMAIN IN FULL FORCE AND EFFECT. AS WITNESS the hands of the duly authorised representatives of the parties hereto the day and year first above written. Signed for and on behalf of *** LONZA BIOLOGICS *** ---------------------------------------- *** ---------------------------------------- TITLE Signed for and on behalf of Peter Thompson TRUBION PHARMACEUTICALS, INC President & CEO TITLE -2-