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Licenses And Royalty Arrangements
9 Months Ended
Sep. 24, 2011
Licenses And Royalty Arrangements [Abstract] 
Licenses And Royalty Arrangements

NOTE 10 LICENSES AND ROYALTY ARRANGEMENTS

We have entered into licenses and royalty agreements for our products in development.

PentaStaph: In 2009, we sold our PentaStaph vaccine candidate and related assets to GSK for a total consideration of up to $46 million, including a $20 million upfront payment and $26 million payable upon achievement of certain milestones related to PentaStaph. At the same time, we received an additional $1 million for the sale of our Staphylococcus epidermidis vaccine program and an additional $0.5 million for the transfer of certain specified materials. We have completed all of the milestones and we received the final $5 million milestone payment in April 2011. We recognized the upfront payment from GSK ratably over the period of our participation on the PentaStaph joint steering committee, which ended in the second quarter of 2011.

 

NicVAX: In 2010, we entered into an exclusive worldwide option and licensing agreement with GSK for our NicVAX vaccine candidate, and the development of follow-on next-generation nicotine vaccine candidates. Under the terms of the agreement, GSK paid us an upfront non-refundable fee of $40 million for (i) an option to exclusively in-license NicVAX on a worldwide basis and (ii) a license to develop follow-on next-generation nicotine vaccines using our intellectual property. In addition to the upfront payment, we are eligible to receive option fees as well as regulatory, development, and sales milestone payments and other payments for NicVAX and follow-on nicotine vaccines. In total, these additional payments may exceed $460 million if GSK exercises the NicVAX option. If GSK does not exercise its option but develops a next-generation candidate, our maximum possible milestones under the agreement would be reduced to $290 million. Under the agreement, we are also eligible to receive royalties on global sales of NicVAX should GSK exercise its option, as well as royalties on global sales of next-generation nicotine vaccines utilizing intellectual property acquired from us regardless of whether GSK exercises its option. In the third quarter we announced that the first of our two Phase III clinical trials failed to meet its primary endpoint (see further detail below), which reduces the likelihood that GSK will exercise its option.

We are recognizing the upfront payment from GSK ratably over the period of our participation on the NicVAX joint steering committee. The joint steering committee is currently expected to continue in effect for 190 months from the date of the NicVAX agreement, or through December 2025. If GSK exercises its option, we will recognize any such option payment over the remaining period of the joint steering committee. We recognize revenues related to the substantive milestones in the periods we complete them.

Other: In November 2006, we sold certain assets related to our PhosLo operations. Under the sale agreement, we received $65 million in cash at closing and $18 million in milestones to date, of which $5 million was related to the first commercial sale of a new liquid formulation and was received in the third quarter of 2011. We also are entitled to additional contingent milestone payments of $2.5 million upon approval of a new indication for PhosLo and royalties of up to $64.5 million on annual sales of the new formulation over a base amount of $32 million for 10 years after the November 14, 2006 closing date.