Development Event. The term “
Development Event. 7 1.12. [**] ................................................................................................................ 7 1.13. Effective Date .............................................................................................. 7 1.14. FDA ............................................................................................................. 7 1.15. FDCA ........................................................................................................... 7 1.16. ICD-11 ......................................................................................................... 7 1.17. Initiation ....................................................................................................... 7 1.18. Know-How ................................................................................................... 7 1.19.
Development Event. (1) Not more than [*] and (2) an acceptable [*] Xxxxx 0 Xxxxxxxxxxx Xxxxx: Not more than [*] EXHIBIT F PRESS RELEASE Media Release Basel, Switzerland and Fremont, CA 16 September, 2004 Roche and Protein Design Labs to jointly develop Zenapax for Asthma Roche and Protein Design Labs (PDL) (NASDAQ: PDLI) today announced a worldwide agreement to co-develop and commercialize Zenapax® (Daclizumab) for asthma and related respiratory diseases, based on recent positive phase II data in patients with moderate to severe asthma. Xxxx XxXxxx, Chief Executive Officer, PDL, said, “The continued development of daclizumab in asthma is among PDL’s highest clinical development priorities. With Roche as our ongoing partner in this indication, we believe daclizumab will obtain the resources needed to develop the full potential of this humanized antibody in asthma.” “This new agreement will strengthen our pipeline in asthma, where we are currently in phase II development of a novel oral treatment,” said Xxxxxxx Xxxxx, Head of Roche’s Pharmaceuticals Division. “We believe that daclizumab will offer patients a significant improvement over today’s current therapy. Our long-standing relationship with PDL continues to grow as we develop daclizumab further.” Under terms of the agreement, PDL will receive a $17.5 million upfront payment as well as up to $187.5 million in development and commercialization milestones for successful further development of daclizumab. Roche and PDL will globally co-develop daclizumab in asthma, share development expenses and co-promote the product in the US. Outside the US, PDL will receive royalties on net sales of the product in asthma. About the Roche - PDL partnership In 1989, Roche acquired the worldwide rights to daclizumab, a product that has since gained an important position within Roche’s transplantation portfolio. In October 2003, Roche resold to PDL all rights to daclizumab, except in transplantation, until 2007 when PDL will have the option to re-acquire the transplantation rights as well. In 2004, PDL approached Roche with compelling phase II data for daclizumab in asthma, leading to today’s announcement for the continued co-development of daclizumab in respiratory disorders by Roche and PDL. About Asthma Asthma is among the most common chronic medical conditions in the United States and worldwide, affecting more than 20 million people in the United States, according to the American Lung Association (ALA) and the American Academy of Allergy...
Development Event. 12 1.33 Dollars ....................................................................................................................... 13 1.34
Development Event. (1) Not more than [****] and (2) an acceptable [****] Xxxxx 0 Xxxxxxxxxxx Xxxxx: Not more than [****] **** Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portions. EXHIBIT E PRESS RELEASE Roche and PDL to Jointly Develop Daclizumab in Transplant Maintenance Therapy Nutley, NJ and Fremont, CA Roche and Protein Design Labs, Inc. (PDL) (NASDAQ: PDLI) today announced an expansion to their partnership to co-develop and commercialize daclizumab for organ transplant patients on long-term, maintenance therapy. Roche currently markets daclizumab for induction transplant therapy as Zenapax®. Roche and PDL are developing a new subcutaneous daclizumab (daclizumab s.c.) formulation, manufactured by PDL, for use in Phase II clinical trials expected to start in 2006. Currently, transplant patients are treated with the combination therapy of Roche’s CellCept® (mycophenolate mofetil) with a calcineurin inhibitor such as cyclosporine and steroids to prevent organ rejection. However, the long-term use of the current calcineurin inhibitors can cause kidney toxicity, diabetes and cardiovascular disorders. Using daclizumab s.c. as maintenance treatment in combination with CellCept may allow for the reduction, and potential elimination, of the more toxic drugs from transplant patient maintenance regimens. Xxxx XxXxxx, Chief Executive Officer, PDL, said, “We are enthusiastic about the opportunity to develop daclizumab s.c. with our longstanding partner Roche. Today’s agreement builds upon our existing collaboration with Roche in asthma, as we continue to explore development of daclizumab s.c. in other indications.” “Roche and PDL are highly committed to daclizumab, our partnership, and in developing better treatments to improve long-term outcomes for transplant patients,” said Xxxxx Xxx, Xxxxx’x Global Head of Pharma Partnering. “With the potential to use CellCept® and daclizumab s.c. as the centerpiece for long-term transplant therapy, we could offer patients a safer, more tolerable option.” Roche and PDL have amended their current agreements to reflect the scope of daclizumab s.c.’s further development. Under the terms of this agreement, PDL will receive a $10 million upfront payment and may be eligible to receive payments up to $145 million if certain milestones are satisfied and if the indication is successfully developed. Roche will continue to manufacture and p...
