PFIZER AGREEMENT TRANSITION	6 Months Ended
Jun. 30, 2013
PFIZER AGREEMENT TRANSITION
PFIZER AGREEMENT TRANSITION	7. PFIZER AGREEMENT TRANSITION In December 2008, the Company entered into a development, commercialization and supply agreement with Pfizer, Inc. (“Pfizer”) (the “Pfizer Agreement”). Under the Pfizer Agreement, the Company granted to Pfizer the right to develop and commercialize, with the right to sublicense, XIAPEX (the European Union tradename for XIAFLEX) for the treatment of Dupuytren’s contracture (“Dupuytren’s”) and, if approved, Peyronie’s disease (“Peyronie’s”) in the European Union (the “EU”) and certain Eurasian countries listed therein (collectively, the “Territory”). On November 6, 2012, the Company and Pfizer (together the “Parties”) entered into an amendment (the “Pfizer Amendment”) to the Pfizer Agreement in which the Parties agreed to mutually terminate the Pfizer Agreement, effective April 24, 2013 (the “Termination Date”). Prior to the Termination Date, the parties continued to perform all of their obligations as described in the Pfizer Agreement. After April 24, 2013, all rights held by Pfizer to commercialize XIAPEX and the responsibility for regulatory activities for XIAPEX in the Territory reverted, at no cost, to the Company. In addition, Pfizer maintained, as provided in the Pfizer Agreement, the right to sell its remaining XIAPEX inventory for the six month period following the Termination Date so long as Pfizer continued to make the commercialization and royalty payments on such sales that were established pursuant to the Pfizer Agreement. On March 28, 2013, the Company and Pfizer entered into a transition services agreement (the “Transition Services Agreement”) relating to the transition from Pfizer to the Company of the development and commercialization activities related to XIAPEX for the treatment of Dupuytren’s and, if approved, for the treatment of Peyronie’s. Notwithstanding the Pfizer Amendment, the Transition Services Agreement provides, and sets out schedules, for, among other matters, an orderly transition of regulatory approvals and licenses, packaging and labeling responsibilities, distribution activities, pharmacovigilance obligations, recall obligations, product testing activities, ongoing clinical trial activities and redesign of packaging. A summary of certain terms of the Transition Services Agreement is set forth below: · Pfizer will assign to the Company the ongoing management and continued performance of certain clinical trials for XIAPEX, including the transfer of data, effective May 31, 2013. · Until July 31, 2013, Pfizer will continue to sell in the Territory any of its XIAPEX inventory that remains on hand and will pay to the Company any commercialization payments due under the original Pfizer Agreement. · The Parties have been cooperating in working toward the transfer of the EU and the Swiss marketing authorizations to the Company and will continue to do so. The EU marketing authorization has now been transferred to the Company. In addition to Pfizer’s selling of its own XIAPEX inventory, Pfizer will distribute XIAPEX on behalf of the Company in the EU and Switzerland until the earlier of the date on which the transfer of the marketing authorizations to the Company have been fully implemented or September 30, 2013. · Upon the transfer of the applicable marketing authorizations, the Company will submit registrations related to pharmacovigilance with respect to XIAPEX. Pfizer will continue to be responsible for the pharmacovigilance system until such registrations have been approved. · Pfizer will package and label XIAPEX bulk product, manufactured by the Company, for the Company’s distribution in the Territory to the extent ordered by the Company by April 5, 2013. (Such order was placed with Pfizer.) The Company will have packaging and labeling responsibility for all subsequent production of XIAPEX. · After February 28, 2014, Pfizer will not provide any further support to the Company with respect to the supply of XIAPEX. · The term of the Transition Services Agreement commenced on March 28, 2013 and ends on April 24, 2014; provided that the rights and obligations of the Parties that expressly terminate on a date prior to April 24, 2014, will terminate on such date.

7. PFIZER AGREEMENT TRANSITION

In December 2008, the Company entered into a development, commercialization and supply agreement with Pfizer, Inc. (“Pfizer”) (the “Pfizer Agreement”). Under the Pfizer Agreement, the Company granted to Pfizer the right to develop and commercialize, with the right to sublicense, XIAPEX (the European Union tradename for XIAFLEX) for the treatment of Dupuytren’s contracture (“Dupuytren’s”) and, if approved, Peyronie’s disease (“Peyronie’s”) in the European Union (the “EU”) and certain Eurasian countries listed therein (collectively, the “Territory”). On November 6, 2012, the Company and Pfizer (together the “Parties”) entered into an amendment (the “Pfizer Amendment”) to the Pfizer Agreement in which the Parties agreed to mutually terminate the Pfizer Agreement, effective April 24, 2013 (the “Termination Date”). Prior to the Termination Date, the parties continued to perform all of their obligations as described in the Pfizer Agreement. After April 24, 2013, all rights held by Pfizer to commercialize XIAPEX and the responsibility for regulatory activities for XIAPEX in the Territory reverted, at no cost, to the Company. In addition, Pfizer maintained, as provided in the Pfizer Agreement, the right to sell its remaining XIAPEX inventory for the six month period following the Termination Date so long as Pfizer continued to make the commercialization and royalty payments on such sales that were established pursuant to the Pfizer Agreement.

On March 28, 2013, the Company and Pfizer entered into a transition services agreement (the “Transition Services Agreement”) relating to the transition from Pfizer to the Company of the development and commercialization activities related to XIAPEX for the treatment of Dupuytren’s and, if approved, for the treatment of Peyronie’s. Notwithstanding the Pfizer Amendment, the Transition Services Agreement provides, and sets out schedules, for, among other matters, an orderly transition of regulatory approvals and licenses, packaging and labeling responsibilities, distribution activities, pharmacovigilance obligations, recall obligations, product testing activities, ongoing clinical trial activities and redesign of packaging.

A summary of certain terms of the Transition Services Agreement is set forth below:

· Pfizer will assign to the Company the ongoing management and continued performance of certain clinical trials for XIAPEX, including the transfer of data, effective May 31, 2013.

· Until July 31, 2013, Pfizer will continue to sell in the Territory any of its XIAPEX inventory that remains on hand and will pay to the Company any commercialization payments due under the original Pfizer Agreement.

· The Parties have been cooperating in working toward the transfer of the EU and the Swiss marketing authorizations to the Company and will continue to do so. The EU marketing authorization has now been transferred to the Company. In addition to Pfizer’s selling of its own XIAPEX inventory, Pfizer will distribute XIAPEX on behalf of the Company in the EU and Switzerland until the earlier of the date on which the transfer of the marketing authorizations to the Company have been fully implemented or September 30, 2013.

· Upon the transfer of the applicable marketing authorizations, the Company will submit registrations related to pharmacovigilance with respect to XIAPEX. Pfizer will continue to be responsible for the pharmacovigilance system until such registrations have been approved.

· Pfizer will package and label XIAPEX bulk product, manufactured by the Company, for the Company’s distribution in the Territory to the extent ordered by the Company by April 5, 2013. (Such order was placed with Pfizer.) The Company will have packaging and labeling responsibility for all subsequent production of XIAPEX.

· After February 28, 2014, Pfizer will not provide any further support to the Company with respect to the supply of XIAPEX.

· The term of the Transition Services Agreement commenced on March 28, 2013 and ends on April 24, 2014; provided that the rights and obligations of the Parties that expressly terminate on a date prior to April 24, 2014, will terminate on such date.