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Related Party Transactions
3 Months Ended
Mar. 31, 2018
Related Party Transactions [Abstract]  
Related Party Transactions

Note 16. Related Party Transactions

Master Assay Development, Commercialization and Manufacturing Agreement

In November 2016, the Company entered into the Governing Agreement, which creates the framework for QML and the Company to combine their technological and commercial strengths to offer biopharmaceutical companies a complete NGS-based solution for the development, manufacture and commercialization of companion diagnostic assays. Under the Governing Agreement, the parties jointly seek companion diagnostic programs with biopharmaceutical companies, QML enters into sponsor project agreements with interested biopharmaceutical companies for specified projects, and QML and the Company enter into statements of work (each, an “SOW”), which set forth the rights and obligations of QML and the Company with respect to each project. There have been no significant modifications or financial events relating to the Governing Agreement since the disclosures made by the Company in its Annual Report on Form 10‑K, filed with the SEC on March 23, 2018, other than with regard to the initiation of new SOWs under the Governing Agreement as discussed below.

 

The Company has determined that SOW One, SOW Two, and SOW Three (each defined below) are collaborative arrangements and that QML meets the definition of a customer under ASC 606. Additionally, each SOW is a separate contract with a single performance obligation to provide development services. Under each SOW, QML pays the Company a monthly fee for development work performed by Company and its subcontractors (collectively, the “Monthly Fee”). The Monthly Fee is based on the employee and materials costs incurred during the month, which is subject to significant variability from period to period and unknown until the costs are incurred. Therefore, the Monthly Fee, which is based on use of hours and costs as a measure of progress, is included in the transaction price and recognized as revenue over time when the costs are incurred and the Monthly Fee is billed to QML. It is at this time that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. The Company and QML also will share any net profits resulting from performance of the development work as determined pursuant to the Governing Agreement. Such profit sharing payment(s) is deemed to be variable consideration using the expected value method and is included in the transaction price upon completion of the respective SOW deliverables, acceptance of corresponding deliverables, and the mutual agreement by QML and the Company on the calculation of net profit, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur.

 

Because each SOW has an expected duration of one year or less, the Company has elected the practical expedient in ASC 606-10-50-14(a) to not disclose information about its remaining performance obligations for each SOW.

 

Statement of Work No. One

In June 2017, the Company and QML entered into the first statement of work under the Governing Agreement, which has been twice amended in December 2017 and March 2018 (collectively, “SOW One”). SOW One addresses the activities of the Company and QML in support of the development and potential commercialization of a next generation sequencing-based companion diagnostic assay that is the subject of a sponsor project agreement between QML and a biopharmaceutical company (“Pharma One”). With the completion of development activities under the original SOW and its first amendment, the second amendment relates to the next-phase development activities, including assay design verification and preparation for regulatory submission, for the project. QML will pay the Company low, single-digit millions of dollars in development fees for the next-phase development activities. In addition, the Company and QML will share in any net profits (as determined under the Governing Agreement) generated in completion of the next-phase milestone deliverables. The next-phase development activities are expected to be completed in the second quarter of 2018. Successful completion of the next-phase activities is expected to lead to further project development activities and the potential commercialization of a companion diagnostic assay for a corresponding Pharma One drug.

 

Revenue of $1,318,718, relating to SOW One Monthly Fees have been included in collaborative development services revenue in the accompanying interim unaudited condensed statements of operations for the three months ended March 31, 2018. Accounts receivable relating to SOW One of $1,295,079 and $2,429,152 remained in the accompanying interim unaudited condensed balance sheets as of March 31, 2018 and December 31, 2017, respectively. Costs relating to development activities conducted by the Company pursuant to SOW One of $1,046,121 have been included in research and development expense in the accompanying interim unaudited condensed statements of operations for the three months ended March 31, 2018. No costs or revenue relating to SOW One were included in the accompanying interim unaudited condensed statements of operations for the three months ended March 31, 2017 as SOW One was not effective until June 2017.

 

Statement of Work No. Two

In October 2017, the Company and QML entered into the second statement of work under the Governing Agreement (“SOW Two”). SOW Two was made effective as of June 2, 2017 (“Onset Date”). SOW Two addresses development activities conducted by the Company and QML since the Onset Date and those expected to be further conducted by parties in connection with a sponsor project agreement, dated June 2, 2017, between QML and BMS (the “BMS/QML SPA”). There have been no significant modifications to SOW Two since the disclosures made by the Company in its Annual Report on Form 10-K, filed with the SEC on March 23, 2018.

 

Revenue of $610,991, relating to SOW Two Monthly Fees have been included in collaborative development services revenue in the accompanying interim unaudited condensed statements of operations for the three months ended March 31, 2018. Accounts receivable relating to SOW Two of $130,133 and $1,796,157 remained in the accompanying interim unaudited condensed balance sheets as of March 31, 2018 and December 31, 2017, respectively. Costs relating to development activities conducted by the Company pursuant to SOW Two of $343,266 have been included in research and development expense in the accompanying interim unaudited condensed statements of operations for the three months ended March 31, 2018. No costs or revenue relating to SOW Two were included in the accompanying interim unaudited condensed statements of operations for the three months ended March 31, 2017 as SOW Two was not established until October 2017.

 

Statement of Work No. Three

In January 2018, the Company and QML entered into a third statement of work (“SOW Three”) under the Governing Agreement. SOW Three relates to development activities for a next generation sequencing-based clinical-trial assay (“SOW Three Project”) in connection with a sponsor project agreement between QML and a pharmaceutical company (“Pharma Three”). If successfully completed, the SOW Three Project is expected to lead to subsequent assay development activities and the potential commercialization of a companion diagnostic assay for a corresponding Pharma Three drug.

Under the terms of SOW Three, the Company has agreed to assign its rights in certain SOW Three Project-related intellectual property (“Project IP”) predominantly related to Pharma Three’s drug candidate(s) to QML for ultimate assignment to Pharma Three in accordance with the sponsor project agreement between QML and Pharma Three. Improvements to the background intellectual property of the Company, QML and Pharma Three generally will be owned solely by the respective party. Otherwise, Project IP will be jointly owned among the Company, QML and Pharma Three.

Pursuant to the terms of SOW Three, if Pharma Three terminates the sponsor project agreement with QML or the SOW Three Project due to the Company’s uncured material breach of SOW Three, the Company will be required to negotiate in good faith with Pharma Three a non-exclusive, royalty-bearing license to certain Company intellectual property as reasonably necessary for Pharma Three to research, develop and commercialize an IVD assay meeting the same specifications as SOW Three.

Neither QML nor the Company have the right to terminate SOW Three or the Governing Agreement to the extent it relates to SOW Three upon a change of control of either party. In addition, if Pharma Three terminates the sponsor project agreement or the SOW Three Project for an uncured material breach that is directly caused by the Company or QML, then, for the non-breaching party, the exclusivity obligation of the Governing Agreement will terminate solely with respect to the development for Pharma Three and/or its affiliates of an IVD assay meeting the same specifications as in SOW Three.

 

 

SOW Three expires upon completion of the SOW Three Project and receipt by the Company of all amounts due for such work. QML will pay the Company for the initial phase development services performed for SOW Three. In addition, the Company and QML will share in any net profits (as determined under the Governing Agreement) generated during the initial phase work on an approximately quarterly basis throughout the term of SOW Three.

Revenue of $348,906, relating to SOW Three Monthly Fees, and $146,491, relating to SOW Three profit sharing payments have been included in collaborative development services revenue in the accompanying interim unaudited condensed statements of operations for the three months ended March 31, 2018. Accounts receivable relating to SOW Three of $495,397 and $0 remained in the accompanying interim unaudited condensed balance sheets as of March 31, 2018 and December 31, 2017, respectively. Costs relating to development activities conducted by the Company pursuant to SOW Three of $226,855 have been included in research and development expense in the accompanying interim unaudited condensed statements of operations for the three months ended March 31, 2018. No costs or revenue relating to SOW Three were included in the accompanying interim unaudited condensed statements of operations for the three months ended March 31, 2017 as SOW Three was not established until January 2018.

 

QNAH Convertible Note Agreement

In October 2017, the Company issued a subordinated convertible promissory note to QNAH in the principal amount of $3.0 million against receipt of cash proceeds equal to such principal amount. There have been no significant modifications or financial events relating to QNAH Convertible Note since disclosures made by the Company in its Annual Report on Form 10-K, filed with the SEC on March 23, 2018.

 

The Company recorded $35,877 and $39,240 of deferred financing costs incurred in connection with the issuance of the note under the QNAH Convertible Note in the accompanying interim unaudited condensed balance sheets as of March 31, 2018 and December 31, 2017, respectively. Amortization of the QNAH Convertible Note deferred financing costs was $3,363 for the three months ended March 31, 2018. Interest accrued on the QNAH Convertible Note for the three months ended March 31, 2018 was $30,822. Both amounts were included in interest expense in the accompanying interim unaudited statements of operations for the three months ended March 31, 2018. There was no interest accrued or deferred financing cost amortization relating to the QNAH Convertible Note for the three months ended March 31, 2017.