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-10.28 31 v18917orexv10w28.txt EXHIBIT 10.28 Exhibit 10.28 AMENDMENT No. 12 to THE DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT Dated 08 January 2004 Between LONZA BIOLOGICS *** and TRUBION PHARMACEUTICALS, INC. THIS AMENDMENT No. 12 ("Twelfth Amendment") is made the 31st day of March 2006 BETWEEN LONZA BIOLOGICS *** of *** (hereinafter referred to as "LB"), and TRUBION PHARMACEUTICALS, 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 ("the Agreement") dated 08 January 2004, pursuant to which LB agreed to provide Services to the Customer, 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 13.5 thereto. NOW THEREFORE IT IS HEREBY AGREED as follows: 1. SCHEDULE 1 OF THE AGREEMENT SHALL BE AMENDED TO INCLUDE THE FOLLOWING: (A) *** Inserted into Agreement by Amendment 11. (B) ***
Storage and shipping information Final Formulation Buffer: *** (Pharmaceutical Grade) Bottling of Bulk Product: Primary containers: *** -2- Denominations: *** Any remaining Product will be filled into ***. If this is not filled with a tolerance of ***, this will be labelled as a Customer Sample and will not be released for clinical use. For the calculation of the total fill volume it is assumed that 1g of liquid ~ 1ml. Product Storage Conditions: ***(0)C Shipment Temperature: ***(0)C Customer samples (removed during the middle of dispensing): To be agreed by LB and Customer. Shipment Temperature: *** 2. SCHEDULE 2 OF THE AGREEMENT SHALL BE AMENDED TO ADD STAGES 36 AND 37 TO READ AS FOLLOWS: 36 "STAGE 36 - *** 36.1 OBJECTIVE *** 36.2 ACTIVITIES *** 36.3 TIMESCALE This Stage may commence when the cell bank *** is available for use, the Process development activities are complete and cGMP documents are approved. This Stage shall be complete upon disposition of Product by LB's Quality department. It is estimated that Product will be delivered *** from commencement of this Stage. ***. It is estimated that this shipment could occur *** from commencement of this Stage. -3- 37 STAGE 37 - *** 37.1 OBJECTIVE *** 37.2 ACTIVITIES *** 37.3 TIMESCALE This Stage may commence when the cell bank *** is available for use, the Process development activities are complete and cGMP documents are approved. This Stage shall be complete upon disposition of Product by LB's Quality department. It is estimated that Product will be delivered *** from commencement of this Stage ***. It is estimated that this shipment could occur *** from commencement of this Stage. -4- SCHEDULE 3 TO THE AGREEMENT SHALL BE AMENDED TO INCLUDE PROVISION FOR PAYMENT FOR THE ABOVE MENTIONED ADDITIONAL SERVICES, AS SET OUT BELOW HERETO. INVOICES FOR THESE ADDITIONAL SERVICES SHALL BE ISSUED, AND CUSTOMER PAYMENTS SHALL BE MADE, IN ***: "1. PRICE *** 2. PAYMENT FOR STAGE 36 *** upon removal of an ampoule out of freeze. *** upon completion of Stage 36. *** FOR STAGE 37 *** upon removal of an ampoule out of freeze. *** upon completion of Stage 37. *** will be invoiced separately -5- (LONZA LOGO) 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 TRUBION PHARMACEUTICALS, INC /s/ Kendall M. Mohler ---------------------------------------- Senior VP, Research & Development TITLE