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ORGANIZATION AND DESCRIPTION OF BUSINESS
6 Months Ended
Jun. 30, 2018
ORGANIZATION AND DESCRIPTION OF BUSINESS [Abstract]  
ORGANIZATION AND DESCRIPTION OF BUSINESS
1. ORGANIZATION AND DESCRIPTION OF BUSINESS

We are a biopharmaceutical company involved in the development of an injectable collagenase clostridium histolyticum for multiple indications. We currently have a development and license agreement with Endo Global Ventures, a Bermuda unlimited liability company (Endo Global Ventures), an affiliate of Endo International plc (Endo), for injectable collagenase for marketed indications and indications in development. Endo assumed this agreement when Endo acquired Auxilium Pharmaceuticals, Inc. (Auxilium) on January 29, 2015 (the Acquisition). Injectable collagenase clostridium histolyticum is marketed as XIAFLEX® (or Xiapex® in Europe).

On February 1, 2016, we entered into with Endo the First Amendment (the First Amendment) to the Second Amended and Restated Development and Licensing Agreement (the Auxilium Agreement), by and between us and Auxilium, now a wholly-owned subsidiary of Endo, to amend certain provisions of the Auxilium Agreement (as amended by the First Amendment, the License Agreement). The effective date of the First Amendment was January 1, 2016. Pursuant to the First Amendment, we and Endo mutually agreed that in exchange for a $8.25 million lump sum payment, we will not receive future additional mark-up on cost of goods sold for sales by non-affiliated sublicensees of Endo outside of the U.S.; provided, however, that Endo will still be required to pay a mark-up on cost of goods sold for sales made in the Endo Territory, which includes sales made in the U.S. and sales made in any other country where Endo sells the product directly or through affiliated sublicensees.

Additionally, we agreed that Endo may opt-in early to indications, prior to our submission of a clinical trial report, with our consent, such consent not to be unreasonably withheld. For early opt-ins, Endo will be required to make an opt-in payment of $0.5 million on a per indication basis. For regular opt-ins, following our submission of a clinical trial report, Endo will be required to make an opt-in payment of $0.75 million on a per indication basis.

The two marketed indications involving our injectable collagenase are Dupuytrens contracture and Peyronies disease. Prior to the Acquisition, Auxilium had, and after the Acquisition, Endo has, opted-in to the following indications: frozen shoulder, cellulite, canine lipoma, lateral hip fat, plantar fibromatosis and human lipoma. Endo exercised, with our consent, an early opt-in for lateral hip fat and plantar fibromatosis in November 2015. Endo opted-in for human lipoma in July 2016. We manage the development of XIAFLEX for uterine fibroids and initiate the development of XIAFLEX in new potential indications, not licensed by Endo.

On November 8, 2016, following a change in Endo management, Endo announced that a commercial review is ongoing of the XIAFLEX exercised but non-marketed indications, including frozen shoulder, cellulite, lateral hip fat, plantar fibromatosis and human lipoma, so that Endo can best prioritize its R&D efforts and determine clinical trial timelines moving forward. On February 6, 2018, Endo initiated two identical Phase 3 RELEASE clinical trials of XIAFLEX for the treatment of cellulite. The multicenter, randomized, double-blind, placebo-controlled RELEASE studies will evaluate the safety and efficacy of XIAFLEX in reducing the appearance of cellulite.

Endo is currently selling XIAFLEX in the U.S. for the treatment of Dupuytrens contracture and Peyronies disease and has an agreement with Swedish Orphan Biovitrum AB (Sobi), pursuant to which Sobi has marketing rights for Xiapex for Dupuytrens contracture and Peyronies disease in Europe and certain Eurasian countries. Sobi is currently selling Xiapex in Europe and certain Eurasian countries for the treatment of Dupuytrens contracture and Peyronies disease. In addition, Endo has an agreement with Asahi Kasei Pharma Corporation (Asahi) pursuant to which Asahi has the right to commercialize XIAFLEX for the treatment of Dupuytrens contracture and Peyronies disease in Japan. Asahi is selling XIAFLEX for the treatment of Dupuytrens contracture in Japan. Endo is currently distributing XIAFLEX in Canada through Paladin Labs Inc., an operating company of Endo. In December 2016, Endo entered into a new out-licensing agreement with Actelion Pharmaceuticals Ltd. (“Actelion”), pursuant to which Actelion obtained marketing and commercial rights for XIAFLEX in Australia and New Zealand.