XML 54 R16.htm IDEA: XBRL DOCUMENT v3.20.1
Collaboration and License Agreements
12 Months Ended
Dec. 31, 2019
Collaboration and License Agreements  
Collaboration and License Agreements

Note 10.  Collaboration and License Agreements

 

Option and License Agreement with Licensee

 

In April 2019, the Company entered into an amended and restated option and license agreement with a privately-held biopharmaceutical company (“Licensee”), pursuant to which the Company granted Licensee (i) exclusive worldwide rights to develop and market IMO-8400 for the treatment, palliation and diagnosis of all diseases, conditions or indications in humans (the “IMO-8400 License”), (ii) an exclusive right and license to develop IMO-9200 in accordance with certain IMO-9200 pre-option exercise protocols (the “IMO-9200 Option Period License”), and (iii) an exclusive option, exercisable at Licensee’s discretion, to obtain the exclusive worldwide rights to develop and market IMO-9200 for the treatment, palliation and diagnosis of all diseases, conditions or indications in humans (the “IMO-9200 Option”) (collectively, the “Licensee Agreement”).  In connection with the Licensee Agreement, the Company transferred certain drug material to Licensee for Licensee’s use in development activities.  Licensee is solely responsible for the development and commercialization of IMO-8400 and, if Licensee exercises the IMO-9200 Option, Licensee would be solely responsible for the development and commercialization of IMO-9200.

 

Note 10.  Collaboration and License Agreements (Continued)

 

Under the terms of the Licensee Agreement, the Company received upfront, non-refundable fees totaling approximately $1.4 million and ownership of 10% of Licensee’s outstanding common stock, subject to future adjustment, for granting Licensee the IMO-8400 License, the IMO-9200 Option Period License and transfer of related drug materials. In addition, the Company is eligible to receive a $1 million non-refundable fee upon Licensee exercising the IMO-9200 Option (“Option Fee”) and is entitled to certain sub-licensing payments on sublicense revenue received by Licensee, if any. The Company may also be eligible for certain development and sales-based milestone payments and royalties on global net sales for any future products. The Company does not anticipate the receipt of any of the future milestones or royalties in the short term, if ever.

 

The Company concluded that the contract counterparty, Licensee, is a customer and accounted for the Licensee Agreement in accordance with ASC 606. As of December 31, 2019, the total transaction price of the contract was $1.4 million, which excluded the Option Fee and all development and sales milestones as all such payments were fully constrained. Additionally, as of December 31, 2019, there were no remaining performance obligations under the Licensee Agreement. The Company re-evaluates its performance obligations and transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

 

As disclosed above, in connection with the Licensee Agreement, the Company owns 10% of Licensee’s outstanding common stock, subject to future adjustment. The Company evaluated the guidance in ASC Topic 321, Investments-Equity Securities, and elected to account for the investment using the measurement alternative as the equity securities are without a readily determinable fair value, and the arrangement does not result in Idera having control or significant influence over Licensee. Accordingly, the securities are measured at cost, less any impairment, plus or minus changes resulting from observable price changes and are recorded in Other assets at a value of less than $0.1 million in the accompanying balance sheets. As of December 31, 2019, the Company considered the cost of the investment to not exceed the fair value of the investment and did not identify any observable price changes.

 

See Note 9 for details on revenue recognized in connection with the Company’s collaboration with Licensee for each of the years ended December 31, 2019, 2018 and 2017.

 

Collaboration with Vivelix

 

In November 2016, the Company entered into an exclusive license and collaboration agreement with Vivelix Pharmaceuticals, Ltd. (“Vivelix”) pursuant to which the Company granted Vivelix worldwide rights to develop and market IMO-9200 for non-malignant gastrointestinal disorders and certain back-up compounds to IMO-9200 (the “Vivelix Agreement”). Under the terms of the Vivelix Agreement, Vivelix was solely responsible for the development and commercialization of IMO-9200 and any designated back-up compounds. In connection with the Vivelix Agreement, Idera also transferred certain drug material to Vivelix for Vivelix’s use in its development activities. Additionally, Vivelix could request that the Company create, characterize and perform research on back-up compounds. 

 

At the effective date of the Vivelix Agreement, Baker Bros. Advisors LP and certain of its affiliated funds (collectively “Baker Brothers”) beneficially owned approximately 7.0% of the Company’s outstanding common stock and affiliates of Baker Brothers constituted two of the four directors on the board of directors of Vivelix and two of the seven directors on the board of directors of the Company.

 

Under the terms of the Vivelix Agreement, the Company received an upfront, non-refundable fee of $15 million related to the license granted for IMO-9200 and back-up compounds to IMO-9200, which was recognized at the inception of the Vivelix Agreement in the fourth quarter of 2016. Additionally, the Company was eligible for future IMO-9200 related development, regulatory and sales milestone payments and sales-based royalties. However, on March 4, 2019, the Company and Vivelix mutually agreed to terminate the Vivelix Agreement.  Accordingly, the Company is no longer eligible to receive any future milestone or royalty-based payments and all rights previously granted to Vivelix with respect to IMO-9200 and certain back-up compounds to IMO-9200 reverted back to the Company.

 

See Note 9 for details on revenue recognized in connection with the Company’s collaboration with Vivelix for each of the years ended December 31, 2019, 2018 and 2017.

Note 10.  Collaboration and License Agreements (Continued)

 

Collaboration with GSK

 

In November 2015, the Company entered into a collaboration and license agreement with GSK to license, research, develop and commercialize pharmaceutical compounds from the Company’s nucleic acid chemistry technology for the treatment of selected targets in renal disease (the “GSK Agreement”). In connection with the GSK Agreement, GSK identified an initial target for the Company to attempt to identify a potential population of development candidates to address such target under a mutually agreed upon research plan. Prior to the wind-down of its discovery operations as more fully described in Note 10, the Company created multiple development candidates to address the initial target designated by GSK. Until November 2019, the expiration of the collaboration term, GSK had the right to designate one development candidate in its sole discretion, from the population of identified candidates, to move forward into clinical development. However, GSK did not designate any candidate for development during the collaboration term. If such designation had occurred, GSK would have been solely responsible for the development and commercialization activities of that designated development candidate.

 

The GSK Agreement also provided GSK with the option to select up to two additional targets at any time during the first two years of the GSK agreement, for further research under mutually agreed upon research plans. Upon selecting additional targets, GSK then had the option to designate one development candidate for each additional target, at which time GSK would have sole responsibility to develop and commercialize each such designated development candidate. GSK did not select any additional targets for research through expiry of the option period.

 

Under the terms of the GSK Agreement, the Company received a $2.5 million upfront, non-refundable, non-creditable cash payment upon the execution of the GSK Agreement.  Additionally, the Company was initially eligible to receive a total of up to approximately $100 million in license, research, clinical development and commercialization milestone payments, of which $9 million of these milestone payments would have been payable by GSK upon the identification of the additional targets, the completion of current and future research plans and the designation of development candidates and $89 million would have been payable by GSK upon the achievement of clinical milestones and commercial milestones. As a result of GSK not designating a development candidate during the collaboration term, the Company is no longer eligible to receive any additional license, research, clinical development and commercialization milestone payments, or any royalty payments.

 

See Note 9 for details on revenue recognized in connection with the Company’s collaboration with GSK for each of the years ended December 31, 2019, 2018 and 2017.

 

Collaboration with Abbott Molecular Inc.

 

In May 2014, the Company entered into a development and commercialization agreement with Abbott Molecular, Inc. (“Abbott Molecular”) for the development of an in vitro companion diagnostic intended to be used in the Company’s prior clinical development programs to treat certain genetically defined forms of B-cell lymphoma with IMO-8400. The agreement provided for the development and subsequent commercialization by Abbott Molecular of a companion diagnostic test utilizing polymerase chain reaction technology to identify with high sensitivity and specificity the presence in tumor biopsy samples of the oncogenic mutation referred to scientifically as MYD88 L265P. Under the agreement, Abbott Molecular was primarily responsible for developing and obtaining regulatory approvals for the companion diagnostic in accordance with an agreed development plan and regulatory plan and for making the companion diagnostic test commercially available in accordance with an agreed commercialization plan. Abbott Molecular would retain all proceeds from commercialization of the companion diagnostic test, if any. In September 2016, the Company suspended internal clinical development of IMO-8400 for B-cell lymphomas. While the Company has maintained its relationship with Abbott, the Company is permitted to terminate the agreement upon 90 days written notice to Abbott Molecular and, under circumstances specified in the agreement, payment of a termination fee and wind-down costs. The parties also may terminate the agreement based on uncured material breaches by or the bankruptcy or insolvency of the other party, and each party has the right to terminate the agreement in the event of specified permanent injunctions based on infringement of third party intellectual property rights.

 

 

Note 10.  Collaboration and License Agreements (Continued)

 

The Company incurred approximately $0.4 million, and $0.8 million in expenses under the Abbott Molecular agreement during the years ended December 31, 2018 and 2017, respectively, related to funding Abbott Molecular’s development of the companion diagnostic test. No such costs were incurred during 2019.