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Other Agreements
6 Months Ended
Jun. 30, 2017
Other Agreements [Abstract]  
Other Agreements

Note 9. Other Agreements

 

NuvoGen Obligation

 

There have been no significant modifications to the terms and conditions of the Company’s NuvoGen obligation since the disclosures made in the Company’s Annual Report on Form 10-K, filed with the SEC on March 23, 2017. The minimum remaining payments due to NuvoGen at June 30, 2017 are as follows for each fiscal year, although actual payments could be significantly more than provided in the table in 2018 and beyond, to the extent that 6% of the Company’s revenue exceeds $400,000:

 

2017

 

$

400,000

 

2018

 

 

400,000

 

2019

 

 

400,000

 

2020

 

 

400,000

 

2021

 

 

400,000

 

2022 and beyond

 

 

6,298,743

 

Total NuvoGen obligation payments

 

 

8,298,743

 

Less discount

 

 

22,741

 

Total NuvoGen obligation, net

 

$

8,321,484

 

 

Development Agreements

 

Illumina, Inc. Agreement

 

In June 2017, the Company entered into an Amended and Restated Development and Component Supply Agreement with Illumina, Inc. (“Illumina”), effective May 31, 2017 (the “Restated Agreement”), which amended and restated the parties’ IVD Test Development and Component Supply Agreement entered into in October 2014 (the “Original Agreement”). The Restated Agreement provides for the development and worldwide commercialization by the Company of nuclease-protection-based RNA or DNA profiling tests (“IVD test kits”) for use with Illumina’s MiSeqDx sequencer in the field of diagnostic oncology testing in humans (the “Field”).

 

Under the Restated Agreement, the parties have agreed to continue activities under the first development plan which was entered into pursuant to the Original Agreement, and the Company may, at its discretion, submit additional development plans for IVD test kits in the Field to Illumina for its approval, not to be unreasonably withheld.

 

Under each development plan, Illumina will provide specified regulatory support and rights, and develop and deliver to the Company an executable version of custom software, which, when deployed on Illumina’s MiSeqDx sequencer, would enable sequencing by the end-user of the subject IVD test kit probe library. Illumina retains ownership of the custom software, subject to the Company’s right to use the custom software in connection with the commercialization of IVD test kits. The Company is required to pay Illumina up to $0.6 million in the aggregate upon achievement of specified regulatory milestones relating to the IVD test kits. There have been no additional contractual milestones reached since the disclosures made by the Company in its Annual Report on Form 10-K, filed with the SEC on March 23, 2017. In addition, the Company has agreed to pay Illumina a single digit percentage royalty on net sales of any IVD test kits that the Company commercializes pursuant to the Restated Agreement. The Company has submitted one additional development plan for an IVD test kit to Illumina, resulting in a required payment to Illumina of $50,000 for the three and six months ended June 30, 2017, included in accounts payable in the condensed balance sheets as of June 30, 2017. Ongoing research and development costs for development plans under the Restated Agreement have been expensed as incurred.

 

Absent earlier termination, the Restated Agreement will expire in May 2027; however, Illumina is no longer obligated to notify the Company of changes in its products that may affect the Company’s IVD test kits after May 31, 2023. The Company may terminate the Restated Agreement at any time upon 90 days’ written notice and may terminate any development plan under the Restated Agreement upon 30 days’ prior written notice. Illumina may terminate the Restated Agreement upon 30 days’ prior written notice if the Company undergoes certain changes of control, subject to a transition period of up to 12 months for then-ongoing development plans. Either party may terminate the Restated Agreement upon the other party’s material breach of the Restated Agreement that remains uncured for 30 days, or upon the other party’s bankruptcy.

 

Other Development Agreements

 

There have been no significant modifications or financial events relating to the development agreements entered into by the Company in prior periods with Invetech PTY Ltd. or Life Technologies Corporation since the disclosures made by the Company in its Annual Report on Form 10-K, filed with the SEC on March 23, 2017.

  

Collaboration Agreements

 

Merck KGaA Agreement

 

The Company earned the first milestone-based payment under its Master CDx Agreement with Merck KGaA, Darmstadt, Germany (“Merck KGaA”) in the second quarter of 2017. Service revenue of $25,000 was recognized for the completion of these research and development services using the proportional performance method of revenue recognition for the three and six months ended June 30, 2017 related to this agreement.

 

Other Collaboration Agreements

 

There have been no significant modifications or financial events relating to the previously disclosed collaboration agreement entered into by the Company with Bristol-Myers Squibb since disclosures made by the Company in its Annual Report on Form 10‑K, filed with the SEC on March 23, 2017.

 

Other Agreements with Related Parties

 

Refer to Note 14 for discussion of agreements with related parties.