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-10.14 17 v18917orexv10w14.txt EXHIBIT 10.14 Exhibit 10.14 AMENDMENT No. 1 to THE DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT Dated 12 AUGUST 2003 Between LONZA BIOLOGICS *** and TRUBION PHARMACEUTICALS, INC. (formerly known as GENECRAFT INC.) Schedule 2 - Services New Stages Stage 2 - *** Stage 3 - *** Schedule 3 - Price and Payment Price and Payment for Stage 2 Price and Payment for Stage 3 Clause 1 - "Customer" Clause 1- "Services" Clause 6.4 - LB Warranties and Indemnity Clause 11.1 - Notices to the Customer Clause 12.5 - Clarification of "Specification" THIS FIRST AMENDMENT ("First Amendment") is made the 7th day of November, 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 ("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 set out in 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. A NEW STAGE, STAGE 2, SHALL BE ADDED TO SCHEDULE 2 OF THE AGREEMENT TO READ AS FOLLOWS: Stage 2 - *** 2.1 OBJECTIVES *** 2.2 ACTIVITIES *** 2.3 TIMESCALE Stage 2 shall commence upon signature of the First Amendment to the Services Agreement to which this Schedule 2 is attached and shall be complete upon issue of the report of activities for Stage 2. It is estimated that Stage 2 will take *** to complete depending on the degree of successful adaptation. This timescale includes *** for generation of the final report. 2 A NEW STAGE, STAGE 3, SHALL BE ADDED TO SCHEDULE 2 TO READ AS FOLLOWS: Stage 3 - *** 3.1 OBJECTIVES *** 3.2 ACTIVITIES *** 3.3 TIMESCALE Stage 3 shall commence upon signature of the First Amendment to the Services Agreement to which this Schedule 2 is attached. This Stage shall be complete upon issue of the report of activities for this Stage. It is estimated that Stage 3 will take *** to complete. 3 SCHEDULE 3 TO THE AGREEMENT SHALL BE AMENDED TO INCLUDE PROVISION FOR PAYMENT FOR THE ABOVE MENTIONED ADDITIONAL SERVICES, AS SET OUT BELOW HERETO: 1. Price
2. Payment 2.1 For Stage 2 *** upon completion of Stage 2. 2.2 For Stage 3 *** upon commencement of Stage 3. *** upon completion of Stage 3. 4 THE TERM "CUSTOMER," AS DEFINED IN CLAUSE 1 OF THE AGREEMENT, SHALL BE AMENDED TO MEAN TRUBION PHARMACEUTICALS, INC., AND ITS SUCCESSORS IN TITLE AND LAWFUL ASSIGNS. 5 THE TERM "SERVICES," AS DEFINED IN CLAUSE 1 OF THE AGREEMENT, SHALL BE AMENDED TO INCLUDE THE NEW STAGE 2 AND STAGE 3 SERVICES WHICH ARE DESCRIBED IN THIS FIRST AMENDMENT AND IN SCHEDULE 2 TO THE AGREEMENT, AS AMENDED BY THIS FIRST AMENDMENT. 6 CLAUSE 6.4 OF THE AGREEMENT SHALL BE AMENDED TO READ IN ITS ENTIRETY AS FOLLOWS: "WITHOUT PREJUDICE TO THE TERMS OF CLAUSES 4.5, 6.3, 6.5 AND 6.6, THE LIABILITY OF LB FOR ANY LOSS OR DAMAGE SUFFERED BY THE CUSTOMER AS A RESULT OF ANY BREACH OF THE AGREEMENT OR OF ANY OTHER LIABILITY OF LB (INCLUDING MISREPRESENTATION AND NEGLIGENCE) IN RESPECT OF THE SERVICES -2- (INCLUDING WITHOUT LIMITATION THE PRODUCTION AND/OR SUPPLY OF THE PRODUCT) SHALL BE LIMITED TO ***." 7 CLAUSE 11.1 OF THE AGREEMENT SHALL BE AMENDED TO PROVIDE THAT NOTICES TO THE CUSTOMER SHALL BE ADDRESSED AND DELIVERED TO TRUBION PHARMACEUTICALS, INC., 2401 4TH AVENUE, SUITE 1050, SEATTLE, WASHINGTON 98121, U.S.A., FACSIMILE: +1 ###-###-####, FOR THE ATTENTION OF: KENDALL M. MOHLER, PH.D., SENIOR VICE PRESIDENT, R&D. 8 FOR THE AVOIDANCE OF DOUBT, THE PARTIES AGREE THAT THE TERM "SPECIFICATION," AS USED IN SECTION 12.5 OF THE AGREEMENT, REFERS TO THE SPECIFICATIONS SET OUT IN SCHEDULE 1 TO THE AGREEMENT. 9. 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 /s/ Kendall Mohler TRUBION PHARMACEUTICALS, INC. ---------------------------------------- Vice President Research & Development TITLE -3-