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Significant Transactions
9 Months Ended
Sep. 30, 2013
Significant Transactions
3. SIGNIFICANT TRANSACTIONS
 
CMIC
 
In 2010, the Company entered into an agreement with CMIC Co., Ltd. (CMIC) to develop and commercialize subcutaneous ecallantide for the treatment of HAE and other angioedema indications in Japan.

Under the terms of the agreement, the Company received a $4.0 million upfront payment.  The Company is also eligible to receive up to $102 million in development and sales milestones for ecallantide in HAE and other angioedema indications and royalties of 20%-24% of net product sales. CMIC is solely responsible for all costs associated with development, regulatory activities, and commercialization of ecallantide for all angioedema indications in Japan. CMIC will purchase drug product from the Company on a cost-plus basis for clinical and commercial supply.

The Company analyzed this multiple element arrangement in accordance with ASC 605 and evaluated whether the performance obligations under this agreement, including the product license, development of ecallantide for the treatment of HAE and other angioedema indications in Japan, steering committee, and manufacturing services should be accounted for as a single unit or multiple units of accounting.  The Company determined that there were two units of accounting.  The first unit of accounting includes the product license, the committed future development services and the steering committee involvement.  The second unit of accounting relates to the manufacturing services.  At this time the scope and timing of the future development of ecallantide for the treatment of HAE and other indications in the CMIC territory are the joint responsibility of the Company and CMIC and therefore, the Company cannot reasonably estimate the level of effort required to fulfill its obligations under the first unit of accounting.  As a result, the Company is recognizing revenue under the first unit of accounting on a straight-line basis over the estimated development period of ecallantide for the treatment of HAE in the CMIC territory through 2016.
 
The Company recognized revenue of approximately $192,000 and $589,000 related to this agreement for the three and nine months ended September 30, 2013, respectively, and approximately $189,000 and $566,000 for the three and nine months ended September 30, 2012, respectively.  As of September 30, 2013 and December 31, 2012, the Company has deferred approximately $2.0 million and $2.5 million, respectively, of revenue related to this arrangement, which is recorded in deferred revenue on the accompanying consolidated balance sheets.

CVie

In February 2013, the Company entered into an agreement with CVie Therapeutics (CVie), a subsidiary of Lee’s Pharmaceutical Holdings Ltd., to develop and commercialize KALBITOR for the treatment of HAE and other angioedema indications in China, Hong Kong and Macau.  Under the terms of this exclusive license agreement, Dyax received a $1.0 million upfront payment and is eligible to receive up to $11 million in future regulatory and sales milestones.  Additionally, the Company is eligible to receive royalties on net product sales.  CVie is solely responsible for all costs associated with development, regulatory activities and the commercialization of KALBITOR in their licensed territories.  CVie will purchase drug product from the Company on a cost-plus basis for its commercial supply when and if KALBITOR is approved for commercial sale in the CVie territories.

The Company analyzed this multiple element arrangement in accordance with ASC 605 and evaluated whether the performance obligations under this agreement, including the product license, steering committee, and manufacturing services should be accounted for as a single unit or multiple units of accounting.  Because of the risk associated with obtaining approval for commercial sale in the CVie territories, manufacturing services associated with commercial supply are considered a contingent deliverable and will be accounting for when and if performed.  As CVie is required to obtain all drug product for both clinical development and commercial demand from the Company, all other deliverables under this arrangement were determined to provide no stand- alone value to the licensee.  Accordingly, it was determined that the license, manufacturing services associated with clinical supply and steering committee performance obligations under this agreement represent a single unit of accounting.

At this time, the Company cannot reasonably estimate the level of effort required to fulfill its obligations and, therefore, is recognizing revenue on a straight-line basis over the estimated development period of ecallantide through mid-2018.

The Company recognized revenue of $47,000 and $125,000 for the three and nine months ended September 30, 2013, respectively. As of September 30, 2013, the Company has deferred $875,000 of revenue related to this arrangement, which is recorded in deferred revenue on the accompanying consolidated balance sheets.

Novellus

In January 2013, the Company entered into an agreement with Novellus Biopharma AG (Novellus) to develop and commercialize KALBITOR for the treatment of HAE and other angioedema indications in select countries in Latin America, including Argentina, Brazil, Chile, Colombia, Mexico and Venezuela.  Under the terms of the exclusive license agreement, the Company is entitled to receive payments totaling $800,000 in 2013, of which $500,000 was received through September 30, 2013.  Additionally, the Company is eligible to receive up to $5.2 million in future regulatory and sales milestones and royalties on net product sales.  Novellus is solely responsible for all costs associated with development, regulatory activities, and the commercialization of KALBITOR in their licensed territories.  Novellus will purchase drug product from the Company on a cost-plus basis for its commercial supply.
 
The Company analyzed this multiple element arrangement in accordance with ASC 605 and evaluated whether the performance obligations under this agreement, including the product license, steering committee, and manufacturing services should be accounted for as a single unit or multiple units of accounting.  As Novellus is required to obtain all drug product for both clinical and commercial demand from the Company, all other deliverables under this arrangement were determined to provide no stand- alone value to the licensee.  Accordingly, it was determined that performance obligations under this agreement represent a single unit of accounting.

The Company will recognize revenue related to this arrangement, including the upfront payments, on a unit output basis, as products under clinical and commercial supply are provided to Novellus.  As no supply has been provided to Novellus to date, no revenue has been recognized during the three and nine months ended September 30, 2013.  As of September 30, 2013, the Company has deferred $800,000 of revenue related to this arrangement, which is recorded in deferred revenue on the accompanying consolidated balance sheets.

Sigma Tau

In June 2010, the Company entered into a strategic collaboration agreement with Sigma-Tau Rare Diseases S.A. (as successor-in-interest to Defiante Farmaceutica S.A.) (Sigma Tau) to develop and commercialize subcutaneous ecallantide for the treatment of HAE and other therapeutic indications throughout Europe, North Africa, the Middle East and Russia.  In December 2010, the original agreement was amended to expand the partnership to commercialize KALBITOR for the treatment of HAE in Australia and New Zealand (the first amendment).  In May 2011, the Company further amended its agreement with Sigma-Tau to include development and commercialization rights in Latin America (excluding Mexico), the Caribbean and certain Asian territories (the second amendment).  Three subsequent amendments to this agreement eliminated rights that Dyax had previously granted to Sigma Tau for the Asian territories, the Middle East, North Africa, Latin America and the Caribbean and in March 2013 rights to the remaining territories (Europe, Russia, Australia and New Zealand) were eliminated under a termination agreement between the Company and Sigma Tau.

Through the date of termination, Sigma Tau made aggregate upfront payments of $7.0 million, payments of $3.8 million for reimbursement associated with development services and purchased 787,647 shares of the Company’s common stock for an aggregate purchase price of $3.0 million.  

Through May 2011, revenue under this arrangement was recognized in accordance with Emerging Issues Task Force Issue 00-21, Revenue Arrangements with Multiple Deliverables.  In May 2011, in conjunction with the second amendment to this agreement, it was determined that the existing arrangement had been materially modified.  As a result, the Company re-evaluated the entire arrangement under ASU No. 2009-13, Revenue Recognition with Multiple Deliverables, as if all modifications since inception were part of the original agreement.  All undelivered items under the agreement were identified and allocated to separate units of accounting based on whether the deliverable provided stand-alone value to the licensee.  The undelivered items as of the date of the second amendment consisted of (i) committed future development services, (ii) steering committee services and (iii) manufacturing services.  Manufacturing services for commercial supply were determined to be a contingent deliverable as the performance of these services were contingent upon Sigma-Tau obtaining regulatory approval in its territories.

All deferred revenue as of the date of modification and additional proceeds received under the second amendment, determined to be attributable to the license granted based on the Company’s best estimate of selling price (BESP), were recognized during the second quarter of 2011.  Management allocated proceeds as of the date of modification to the steering committee and development services based on BESP which was recognized under the proportional performance model as work was performed. 

The principal terms of the March 2013 termination agreement included provision for (i) the revocation of all licenses granted by the Company to Sigma Tau, (ii) the termination of all other obligations under the license agreement, (iii) the issuance of 271,665 shares of the Company’s common stock to Sigma Tau, and (iv) the right of Sigma Tau to receive $500,000 for every $5.0 million of compensation received by the Company during the next ten years in relation to the potential license or supply of ecallantide exclusively in those territories that had been previously licensed to Sigma Tau.  In accordance with ASC 605-50, the $1.1 million determined to be the fair value of the common stock as of the date of issuance was recorded as a reduction to development and license fee revenue on the Company’s statement of operations and $85,000 of deferred revenue attributable to the JSC services was recognized as revenue for the nine months ended September 30, 2013.  No additional revenue is expected to be recognized in future periods.  For the three and nine months ended September 30, 2012, revenue recognized under this arrangement totaled $69,000 and $156,000, respectively.