UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
W ASHINGTON , DC 20549
FORM 10-Q
(Mark One)
☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 3 1 , 201 6
OR
☐ TRANSITION REPORT UNDER SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ______ to ______
Commission f ile n umber: 001-34810
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Delaware |
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33-0595156 |
(State or Other Jurisdiction of Incorporation or Organization ) |
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(I.R.S. Employer Identification No.) |
12117 Bee Caves Road, Building Three, Suite 100, Austin, Texas |
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78738 |
(Address of Principal Executive Offices ) |
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(Zip Code) |
(512) 519-0400
(Registrant’s Telephone Number, Including Area Code )
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter ) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☑ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check o ne ):
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Large accelerated filer ☐ |
Accelerated filer ☐ |
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Non-accelerated filer ☐ |
Smaller reporting company ☑ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☑ No ☐
As of April 30 , 201 6 , the registrant had 52,116,600 shares of common stock, par value $0.001 per share, outstanding.
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VERMILLION, INC.
FORM 10-Q
Table of Contents
Vermillion , OVA1 and Overa are registered trademarks of Vermillion, Inc.
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PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
Condensed Consolidated Balance Sheets
( Amounts in Thousands, Except Share and Par Value Amounts)
(Unaudited)
See accompanying notes to the unaudited c ondensed consolidated financial statements.
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Condensed Consolidated Statements of Operations
(Amounts in Thousands, Except Share and Per Share Amounts)
(Unaudited)
See accompanying notes to the unaudited c ondensed consolidated financial statements.
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Condensed Consolidated Statements of Cash Flows
(Amounts in Thousands)
(Unaudited)
See accompanying notes to the unaudited c ondensed consolidated financial statements .
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Notes to C ondensed Consolidated Financial Statements
(Unaudited)
1. ORGANIZATION, BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING AND REPORTING POLICIES
Organization
Vermillion, Inc. (“Vermillion”; Vermillion and its wholly-owned subsidiaries are collectively referred to as the “Company”) is incorporated in the state of Delaware, and is engaged in the business of developing and commercializing diagnostic tests for gynecologic disease. The Company sells OVA1™ risk of malignancy test for ovarian cancer (“OVA1”). Until August 10, 2015, the Company distributed OVA1 through Quest Diagnostics Incorporated (“Quest Diagnostics”) (see Note 2 ). Since August 10, 2015, the Company has distributed all but a nominal number of OVA1 tests through Vermillion’s wholly-owned Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) certified clinical laboratory, ASPiRA LABS, Inc. (“ASPiRA LABS”), which opened in June 2014 . The Company also plans to offer in-vitro diagnostic (“IVD”) trial services to third-party customers through its wholly-owned subsidiary, ASPiRA IVD, Inc. (“ASPiRA IVD”), which was formed in April 2016. The Company plans for ASPiRA IVD to be a specialized laboratory provider dedicated to meeting the unique testing needs of IVD manufacturers seeking to commercialize high-complexity assays. The Company’s goal is to build ASPiRA IVD around a core of laboratory expertise and a United States Food and Drug Administration (“FDA”)-compliant quality system, with an emphasis on delivering accurate and reliable results to its third-party customers suitable for FDA submission.
Going Concern
The Company has incurred significant net losses and negative cash flows from operations since inception, and as a result has an accumulated deficit of approximately $ 375, 48 5 ,000 at March 31, 2016. The Company expects to incur a net loss and negative cash flows from operations in 2016 and the foreseeable future. The Company’s management believes that successful achievement of the Company’s business objectives will require additional financing. Given these conditions, there is substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties.
The Company expects to raise capital through a variety of sources, which may include the public equity market, private equity financing, collaborative arrangements, licensing arrangements, and/or public or private debt. However, additional funding may not be available when needed or on terms acceptable to the Company. If the Company is unable to obtain additional capital, it may not be able to continue sales and marketing, research and development, or other operations on the scope or scale of current activity and that could have a material adverse effect on its business, results of operations and financial condition.
As discussed in Note 3, on March 22, 2016, the Company entered into an agreement (the “Loan Agreement”) pursuant to which it may borrow up to $4,000,000 from the State of Connecticut Department of Economic and Community Development (the “DECD”). An initial disbursement of $2,000,000 was made to the Company on April 15, 2016 under the Loan Agreement. The Loan Agreement provides that the remaining $2,000,000 will be disbursed if and when the Company achieves certain future milestones.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim
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financial information and with the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management of the Company, all adjustments, consisting of normal recurring adjustments necessary for the fair statement of results for the periods presented, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period.
The unaudited condensed consolidated financial statements and related disclosures have been prepared with the presumption that users of the interim unaudited condensed consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding fiscal year. The condensed consolidated balance sheet at December 31, 2015 included in this report has been derived from the audited consolidated financial statements at that date but does not include all the information and footnotes required by GAAP. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2015 , included in Vermillion’s Annual Report on Form 10-K which was filed with the Securities and Exchange Commission on March 30 , 2016 (the “2015 Annual Report”) .
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimated results.
Significant Accounting and Reporting Policies
Revenue Recognition
The Company has adopted ASC 954-605, Health Care Entities—Revenue Recognition as revenue from laboratory services has become more significant to the C ompany . The Company's revenue is generated by performing diagnostic services using its OVA1 test , and the service is completed upon the delivery of test results to the prescribing physician. The Company recognizes revenue related to billings for Medicare and commercial payers on an accrual basis, net of contractual and other adjustments, when amounts that will ultimately be realized can be estimated. Until a contract has been negotiated with a commercial payer or governmental program, the OVA1 test may or may not be covered by these entities' existing reimbursement policies. In addition, patients do not enter into direct agreements with the Company that commit them to pay any portion of the cost of the tests in the event that their insurance declines to reimburse the Company. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment from the patient, the related revenue is only recognized upon cash receipt.
E stimates of amounts that the Company will ultimately realize require significant judgment by management. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, and the Company may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with the patient’s health plan. Some payers may not cover the OVA1 test as ordered by the prescribing physician under their reimbursement policies. The Company pursues reimbursement from such patients on a case-by-case basis. In the absence of contracted reimbursement coverage or the ability to estimate the amount that will ultimately be realized for the Company's services, revenue is recognized when cash is received.
Revenue recognized when cash is received and on an accrual basis for the three months ended March 31, 2016 and 2015 was as follows:
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The Company has made no other significant changes in its critical accounting policies and estimates from those disclosed in the 2015 Annual Report .
2. AGREEMENTS WITH QUEST DIAGNOSTICS INCORPORATED
In July 2005, the Company entered into a Strategic Alliance Agreement (as amended, the “Strategic Alliance Agreement”) with Quest Diagnostics to develop and commercialize up to three diagnostic tests from the Company’s product pipeline. In connection with the Strategic Alliance Agreement, the Company entered into a credit agreement with Quest Diagnostics, pursuant to which Quest Diagnostics provided the Company with a $10,000,000 secured line of credit to be used to pay for certain costs and expenses related to activities under the Strategic Alliance Agreement. This line of credit was collateralized by certain of the Company’s intellectual property assets. The credit agreement provided for the forgiveness of portions of the amounts borrowed under the secured line of credit upon the achievement of certain milestones related to the development, regulatory approval and commercialization of certain diagnostic tests. Through December 31, 2014, the entire loan was either repaid or forgiven except for $1,106,000 which was in dispute. The dispute regarding the balance of the loan was resolved on March 11, 2015 for a payment to Quest Diagnostics totaling $1,069,000 . As a result of this settlement, the Company recognized one-time items during the year ended December 31, 2015, including product revenue of $163,000 , license revenue of $202,000 , gain on extinguishment of debt of $37,000 and reversal of other liabilities totaling $41,000 .
Unrelated to the debt dispute described above, in August 2013, the Company sent Quest Diagnostics a notice of termination of the Strategic Alliance Agreement. Notwithstanding the termination, the Company agreed that Quest Diagnostics could continue to make OVA1 available to healthcare providers on the same financial terms following the termination while negotiating in good faith towards an alternative business structure. Quest Diagnostics disputed the effectiveness of the termination. Prior to the termination, Quest Diagnostics had the non-exclusive right to commercialize OVA1 on a worldwide basis, with exclusive commercialization rights in the clinical reference laboratory marketplace in the United States, India, Mexico, and the United Kingdom through September 2014, with the right to extend the exclusivity period for one additional year.
On March 11, 2015, the Company reached a settlement agreement with Quest Diagnostics that terminated all disputes related to the Strategic Alliance Agreement and the Company’s prior loan agreement with Quest Diagnostics. The Company also entered into a new commercial agreement with Quest Diagnostics. Pursuant to this agreement, all OVA1 U.S. testing services for Quest Diagnostics customers were transferred to Vermillion’s wholly-owned subsidiary, ASPiRA LABS, as of August 10, 2015, with the exception of a nominal number of OVA1 tests distributed through Quest Diagnostics after that date. Quest Diagnostics is continuing to provide blood draw and logistics support by transporting specimens from its clients to ASPiRA LABS for testing through at least March 11, 2017 in exchange for a market value fee. Per the terms of the new commercial agreement, the Company will not offer to existing or future Quest Diagnostics customers CA 125-II or other tests that Quest Diagnostics offers.
On June 17, 2015, the Company entered into a Share Repurchase Agreement (the “Share Repurchase Agreement”) with Quest Diagnostics. Pursuant to the Share Repurchase Agreement, the Company purchased from Quest Diagnostics 860,595 shares of Vermillion common stock for a total purchase price of $1,290,892 , or $1.50 per share. The price per share was agreed to in principle in March 2015 and based upon a simple average of the closing prices per share of Vermillion common stock for a trailing 60-day period at that time. This price was then reduced by a negotiated discount. Subsequently, the common stock repurchased from Quest Diagnostics was retired.
3. COMMITMENT AND CONTINGENCIES
Development Loan
On March 22, 2016, the Company entered into the Loan Agreement, pursuant to which the Company may borrow up to $4,000,000 from the DECD. Proceeds from the loan are to be utilized primarily to fund the build-out, information technology infrastructure and other costs related to the Company’s Trumbull, Connecticut facility and operations. The loan bears interest at a fixed rate of 2.0% per annum and requires equal monthly payments of
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principal and interest until maturity, which occurs on April 15, 2026 . As security for the loan, the Company has granted the DECD a blanket security interest in the Company’s personal and intellectual property. The DECD’s security interest in the Company’s intellectual property may be subordinated to a qualified institutional lender. Under the terms of the Loan Agreement, the Company may be eligible for forgiveness of up to $2,000,000 of the principal amount of the loan if the Company achieves certain job creation and retention milestones by March 1, 2018. If the Company is unable to meet these job creation milestones within the allotted timeframe or does not maintain the Company’s Connecticut operations for a period of 10 years, the DECD may require early repayment of a portion or all of the loan depending on job attainment as compared to the required amount.
A n initial disbursement of $2,000,000 was made to the Company on April 15, 2016 under the Loan Agreement . The Loan Agreement provides that the remaining $2,000,000 will be disbursed if and when the Company achieves certain future milestones. The loan may be prepaid at any time without premium or penalty .
Operating Leases
The Company leases facilities to support its business of discovering, developing and commercializing diagnostic tests in the fields of gynecologic disease, including its principal facility and CLIA laboratory located in Austin, Texas. As of March 31, 201 6 there were two Austin, Texas leases which included an aggregate annual base rent of $ 115 ,000 and annual estimated common area charges, taxes and insurance of $ 58 ,000 . The lease which includes the CLIA laboratory expires on May 31, 2017 and an additional lease is month to month and requires 90 days’ notice to cancel.
In October 2015, the Company entered a lease agreement for a facility in Trumbull, Connecticut. The lease required initial payments for the buildout of leasehold improvements to the office space, which were approximately $ 596 ,000 . The term of the lease is five years beginning after the initial date of occupancy o n January 8, 2016 and a rent abatement period of five months. The lease includes an aggregate annual base rent of $32,000 and annual estimated common area charges, taxes and insurance of $91,000 .
Rental expense under operating leases for the three months ended March 31, 201 6 and 201 5 totaled $ 51 ,000 and $ 42 ,000 , respectively.
Capital Lease
In April 2015, the Company agreed to lease two laboratory instruments for a total initial payment of $250,000 and ongoing payments of approximately $7,000 per month for 36 months after delivery. The agreement also requires minimum annual purchases of reagents from the manufacturer of the equipment. As of March 31, 201 6 , one instrument has been delivered and placed into service.
The accumulated amortization of assets under capital lease obligations was $ 58 ,000 and the net book value of assets under capital lease obligations was $1 74 ,000 as of March 31, 201 6 . There were no assets under capital lease obligations as of March 31, 201 5 .
Non-cancelable Royalty Obligations
The Company is a party to an amended research collaboration agreement with The Johns Hopkins University School of Medicine (“JHU”) under which the Company license s certain of its intellectual property . Under the terms of the amended research collaboration agreement, Vermillion is required to pay the greater of 4% royalties on net sales of diagnostic tests using the assigned patents or annual minimum royalties of $57,500 . Royalty expense for the three months ended March 31, 201 6 and 201 5 tota l led $ 20 ,000 and $ 25 ,000 , respectively.
4. STOCKHOLDERS’ EQUITY
2010 Stock Incentive Plan
The Company’s employees, directors, and consultants are eligible to receive awards under the Vermillion, Inc. Second Amended and Restated 2010 Stock Incentive Plan (the “2010 Plan”). The 2010 Plan permits the granting of a variety of awards, including stock options, share appreciation rights, restricted shares, restricted share
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units, unrestricted shares, deferred share units, performance and cash-settled awards, and dividend equivalent rights. The 2010 Plan provides for issuance of up to 8,122,983 shares of Vermillion common stock, subject to adjustment as provided in the 2010 Plan.
Stock-Based Compensation
During the three months ended March 31, 2016, the Company awarded to Vermillion’s non-employee directors 2 11 ,000 shares of restricted stock under the 2010 Plan having a fair value of approximately $3 32 ,000 as payment for services to be rendered in 2016. These shares of restricted stock will vest 50% on June 1, 2016 and 25% on each of September 1, 2016 and December 1, 2016. The Company also granted certain consultants options to purchase 10 0,000 shares of Vermillion common stock with an exercise price of $1.64 per share. 50,000 of t hese stock options vest 25% on each of the four anniversaries of the grant date, and the remaining 50,000 of these stock options have performance-based vesting based on certain metrics through December 31, 2016. The Company also granted certain employees retention options to purchase 35,000 shares of Vermillion common stock with an exercise price of $1.64 per share and retention options to purchase 7 3,000 shares of Vermillion common stock with an exercise price of $1.37 per share , each of which vest one year from the grant date. The Company also granted certain officers and employees options to purchase approximately 886 ,000 shares of Vermillion common stock with an exercise price of $1.57 per share. All but 4,000 of t hese stock options vest 25% on each of the four anniversaries of the grant date . T he remaining 4,000 stock options vest fully on February 5, 2017 . In addition, during the three months ended March 31, 2016 the Company granted certain officers and employees options to purchase 25 0,000 shares of Vermillion common stock with an exercise price of approximately $1.57 per share with performance-based vesting based on certain metrics through December 31, 2016.
The allocation of employee stock-based compensation expense by functional area for the three months ended March 3 1 , 201 6 and 201 5 was as follows:
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Three Months Ended March 31, |
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(in thousands) |
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2016 |
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2015 |
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Cost of revenue |
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$ |
24 |
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$ |
9 |
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Research and development |
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31 |
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31 |
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Sales and marketing |
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42 |
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37 |
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General and administrative |
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105 |
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88 |
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Total |
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$ |
202 |
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$ |
165 |
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5 . LOSS PER SHARE
The Company calculates basic loss per share using the weighted average number of common shares outstanding during the period. Because the Company is in a net loss position, diluted loss per share is calculated using the weighted average number of shares of common stock outstanding and excludes the effects of 8,709,504 and 7,040,587 potential shares of common stock as of March 31 , 2016 and 2015 , respectively, that are anti-dilutive. Potential shares of common stock include incremental shares of common stock issu able upon the exercise of outstanding warrants , stock options and unvested restricted stock units.
6. Related Party Transaction
On January 18, 2016, the Company entered into a consulting agreement with David Schreiber, a member of Vermillion’s Board of Directors. Pursuant to the terms of the consulting agreement, Mr. Schreiber provide d consulting services regarding business strategies and operational plans and was paid $375 per hour , with a minimum payment of $51,750 for the period up to the expiration of the agreement on March 31, 2016. As of March 31, 2016, t he Company had paid Mr. Schreiber $13,000 , and an additional $ 39 ,000 was payable to him under such agreement .
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Forward - Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995.
These statements involve a number of risks and uncertainties. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify such forward-looking statements. Readers are cautioned that these forward-looking statements speak only as of the date on which th is Quarterly Report on Form 10-Q is filed with the Securities and Exchange Commission (“ SEC ”) , and, except as required by law, Vermillion, Inc. (“Vermillion” and together with its subsidiaries, the “Company , ” “we , ” “our , ” or “us”) does not assume any obligation to update, amend or clarify them to reflect events, new information or circumstances occurring after such date.
Examples of forward-looking statements regarding our business include the following:
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Forward-looking statements are subject to significant risks and uncertainties, including those discussed in Part I, Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2015 (our “2015 Annual Report”) and this Quarterly Report on Form 10- Q , that could cause actual results to differ materially from those projected in such forward-looking statements due to various factors, including our ability to increase the volume of OVA1 sales; our ability to market our test through sales channels other than Quest Diagnostics Incorporated (“Quest Diagnostics”) including ASPiRA LABS; failures by third-party payers to reimburse OVA1 or changes or variances in reimbursement rates; our ability to secure additional capital on acceptable terms to execute our business plan ; our ability to commercialize O vera both within and outside the United States; in the event that we
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succeed in commercializing O vera outside the United States, the political, economic and other conditions affecting other countries (including foreign exchange rates); our ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; our ability to compete successfully; our ability to obtain any regulatory approval required for our future diagnostic products; our or our suppliers’ ability to comply with United States Food and Drug Administration (“FDA”) requirements for production, marketing and post-market monitoring of our products; additional costs that may be required to make further improvements to our manufacturing operations; our ability to maintain sufficient or acceptable supplies of immunoassay kits from our suppliers; our ability to continue to develop, protect and promote our proprietary technologies; future litigation against us, including infringement of intellectual property and product liability exposure; our ability to retain key employees; business interruptions; legislative actions resulting in higher compliance costs; changes in healthcare policy; our ability to comply with environmental laws; our ability to generate sufficient demand for ASPiRA LABS’ services to cover its operating costs; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of ASPiRA LABS; our ability to comply with FDA regulations that relate to our products and to obtain any FDA clearance or approval required to develop and perform laboratory-developed tests (“ LDTs ”) ; ASPiRA IVD’s lack of operating history; ASPiRA IVD’s ability to generate and maintain business; fluctuations over time with respect to ASPiRA IVD’s operating results; ASPiRA IVD’s ability to enter into profitable contracts; ASPiRA IVD’s ability to maintain effective information systems without significant interruption; and ASPiRA IVD’s ability to perform its services in compliance with contractual requirements, regulatory standards and ethical considerations.
Overview
Our vision is to drive the advancement of women’s health by providing innovative methods to detect, monitor and manage the treatment of both benign and malignant gynecologic disease, with our primary focus being diseases of the female pelvic cavity.
We have expanded our corporate strategy with the goal of transforming Vermillion from a technology license company to a diagnostic service and bio-analytic solutions provider. Our plan is to broaden our commercial focus from ovarian cancer to differential diagnosis of women with a range of gynecologic al disorders. Our strategy is being deployed in three phases. The three phases are a rebuild phase, which was completed in the third quarter of 2015, a transformation phase, which is ongoing, and a market expansion and growth phase, which we expect to begin in 2016.
During the first phase, we expanded our leadership team by hiring several new senior leaders including a chief executive officer. In addition, we expanded our commercial strategy, re-established medical and advisory support, rebuilt our patient advocacy strategy and established a billing system and a payer strategy outside of our relationship with Quest Diagnostics. During the second phase, we completed the process of obtaining licensure of ASPiRA LABS in all of the states that require licenses and plan to establish our own payer coverage for OVA1 and launch a second-generation OVA1 test, trademarked Overa. In the third phase we plan to commercialize Overa by utilizing the full national licensure of ASPiRA LABS, managed care coverage in select markets, our sales force and existing customer base. Unlike OVA1, Overa uses a global testing platform, which will allow Overa to be deployed internationally. On October 26, 2015, we announced registration of the CE mark for and clearance to market Overa in the European Union. We also plan to develop an LDT product series, which we refer to internally as OvaX. We anticipate that OvaX will include not only biomarkers, but also clinical risk factors, other diagnostics and patient history data in order to boost predictive value. On February 11, 2016, we adopted a plan to streamline our organization. We have reduced headcount and other expenses targeting an approximately 20% reduction in go-forward operating expenses in 2016, as compared to operating expenses in 2015.
We are dedicated to the discovery, development and commercialization of novel high-value diagnostic and bio-analytical solutions that help physicians diagnose, treat and improve outcomes for women. Our tests are intended to detect, characterize and stage disease, and to help guide decisions regarding patient treatment, which may include decisions to refer patients to specialists, to perform additional testing, or to assist in monitoring response to therapy. A distinctive feature of our approach is to combine multiple biomarkers, other modalities and diagnostics, clinical risk factors and patient data into a single, reportable index score that has higher diagnostic accuracy than its constituents. We concentrate on our development of novel diagnostic tests for gynecologic disease, with an initial focus on ovarian cancer. We also intend to address clinical questions related to early disease
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detection, treatment response, monitoring of disease progression, prognosis and others through collaborations with leading academic and research institutions.
Our initial product, OVA1, is a blood test designed to, in addition to a physician’s clinical assessment of a woman with a pelvic mass, identify women who are at high risk of having a malignant ovarian tumor prior to planned surgery. The FDA cleared OVA1 in September 2009 , and we commercially launched OVA1 in March 2010. We have completed a second-generation biomarker panel known as Overa, which is intended to maintain our product’s high sensitivity while improving specificity. We submitted our 510(k) clearance application for Overa to the FDA in March 2015, with the goal of commencing the marketing and sale of the panel on a targeted basis in 2016. We received FDA clearance for Overa on March 18, 2016. Overa uses the Roche cobas 6000 platform .
In June 2014, Vermillion launched ASPiRA LABS, a Clinical Laboratory Improvements Amendments of 1988 (“CLIA”) certified national laboratory based in Austin, Texas, which specializes in applying biomarker-based technologies to address critical needs in the management of gynecologic cancers and disease. ASPiRA LABS provides expert diagnostic services using a state-of-the-art biomarker-based diagnostic algorithm to aid in clinical decision making and advance personalized treatment plans. The lab currently processes our OVA1 test, and we expect the lab to process the CA 125-II test (which is marketed and sold by a third party) in the future in specific markets although we are prohibited from offering CA 125-II tests to existing or future Quest Diagnostics customers (see Note 2 to our first quarter 2016 unaudited financial statements above) . We plan to expand the testing provided by ASPiRA LABS to other gynecologic conditions with high unmet need. We also plan to develop and perform LDTs at ASPiRA LABS. ASPiRA LABS holds a CLIA Certificate of Registration and a state laboratory license in California, Florida, Maryland, New York, Pennsylvania and Rhode Island. This allows the lab to process OVA1 on a national basis. The Centers for Medicare & Medicaid Services issued a provider number to ASPiRA LABS in March 2015.
In 2016, we began creati ng a new service within the ASPiRA channel strategy, “an ASPiRA IVD Services Program”. In April 201 6 , we formed ASPiRA IVD with plans to offer IVD t rial services to thi rd - party customers. We plan for A SPiRA IVD to be a specialized laboratory provider dedicated to meeting the unique testing needs of IVD manufacturers seeking to commercializ e high-complexity assays. Our goal is to build A SPiRA IVD around a core of laboratory expertise and a FDA-compliant quality system , with an emphasis on delivering accurate and reliable results to its third-party customers suitable for FDA submission . ASPiRA IVD ha s applied for a CLIA laboratory license and intend s to commence operations in the third quarter of 2016 .
In this program, we also plan to leverage our existing infrastructure and enhance our pipeline of future technologies by fostering relationships with IVD companies who are developing new diagnostics including companion diagnostics platforms. We believe this plan will allow us to continue to be innovative in evaluating potential diagnostics. Our goal with the addition of this line of business is to invest in our short - term and long - term enterprise value while leveraging our specimen bank, database, FDA experience, laboratory informatics and operating efficiency.
Strategy:
We are focused on the execution of f ive core strategic business drivers in ovarian cancer diagnostics and specialized laboratory services to build long-term value for our investors:
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Improving OVA1 performance by obtaining FDA clearance of Overa, a next generation biomarker panel while migrating OVA1 to a global testing platform, which we believe may allow for better domestic market penetration and international expansion (FDA clearance was received on March 18, 2016); |
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Building an expanded patient base by launching a next generation multi-marker ovarian cancer test (distinct from Overa) to monitor patients at risk for ovarian cancer; |
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Expanding our product offerings by adding additional gynecologic bio-analytic solutions involving biomarkers, other modalities (e.g., imaging), clinical risk factors and patient data to aid in the diagnosis and risk stratification of women presenting with a pelvic mass disease ; and |
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Expanding our customer offerings with the launch of our ASPiRA IVD laboratory services . |
We believe that these business drivers will contribute significantly to addressing unmet medical needs for women faced with gynecologic disease and other conditions and the continued development of our business.
OVA1 addresses a clear clinical need, namely the pre - surgical identification of women who are at high risk of having a malignant ovarian tumor. Numerous studies have documented the benefit of referral of these women to gynecologic oncologists for their initial surgery. Prior to the clearance of OVA1, no blood test had been cleared by the FDA for physicians to use in the pre - surgical management of ovarian adnexal masses. OVA1 is a qualitative serum test that utilizes five well-established biomarkers and proprietary software cleared as part of the OVA1 510(k) to determine the likelihood of malignancy in women over age 18, with a pelvic mass for whom surgery is planned. OVA1 should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of OVA1 carries the risk of unnecessary testing, surgery and delayed diagnosis. OVA1 was developed through large pre-clinical studies in collaboration with numerous academic medical centers encompassing over 2,500 clinical samples. OVA1 was fully validated in a prospective multi-center clinical trial encompassing 27 sites reflective of the diverse nature of the clinical centers at which ovarian adnexal masses are evaluated.
In May 2015 we announced that the Company was approved for a product development grant from CPRIT for $7,500,000, to help fund the Company's new multi-site pelvic mass registry. The grant would assist the Company in creating a first-in-kind clinical registry of patients undergoing evaluation, diagnosis, treatment and follow-up for pelvic masses that may lead to gynecologic malignancy. Receipt of the grant award is subject to execution of a grant contract on terms acceptable to both Vermillion and CPRIT which may include such terms as payment of future product royalties to CPRIT by Vermillion. Negotiations with CPRIT are ongoing.
On April 20, 2016, we announced the publication of the first clinical utility data demonstrating that identification of high-risk patients using OVA1 prior to surgery resulted in referral of nearly all patients who had primary ovarian malignancies to gynecologic oncologists. The study, titled “The clinical utility of an elevated-risk multivariate index assay score in ovarian cancer patients ,” to be published in the peer-reviewed journal Current Medical Research & Opinion , is now available online as a pre-print ( 10.1080/03007995.2016.1176014 ).
The study surveyed physicians who frequent ly used OVA1, and identified 122 patients who underwent surgery for a pelvic mass after a high-risk OVA1 score was reported. Of these, 65 had a primary ovarian malignancy, while the remainder were benign or had a metastatic cancer of non-ovarian origin. Pre-surgical involvement of a gynecologic oncologist was documented, including referral, consultation or availability on stand-by; and the specialty of the surgeon who performed the adnexal surgery was also recorded. Of the 4 patients whose surgery was not performed by a gynecologic oncologist, 2 required re-operation for complete staging by a gynecologic oncologist. In comparison, none of the 61 ovarian cancers that were operated on by a gynecologic oncologist required restaging. According to the National Academy of Medicine’s 2016 report titled , “ , ” re-operations are common after non-specialists operate on ovarian cancer, and may result in delayed treatment, higher costs and inferior outcomes compared with ‘first time right’ surgery by a gynecologic oncologist.
On May 13, 2016, we entered into our first international distribution agreement for Overa. Bio- Medical Science Co., Ltd. will market and distribute Overa on an exclusive basis in South Korea.
Critical Accounting Policies and Estimates
Revenue Recognition
We have adopted ASC 954-605, Health Care Entities—Revenue Recognition as revenue from laboratory services has become more significant to us . Our revenue is generated by performing diagnostic services using our OVA1 test , and the service is completed upon the delivery of test results to the prescribing physician. We recognize
18
revenue related to billings for Medicare and commercial payers on an accrual basis, net of contractual and other adjustments, when amounts that will ultimately be realized can be estimated. Until a contract has been negotiated with a commercial payer or governmental program, the OVA1 test may or may not be covered by these entities' existing reimbursement policies. In addition, patients do not enter into direct agreements with us that commit them to pay any portion of the cost of the tests in the event that their insurance declines to reimburse us. In the absence of an agreement with the patient or other clearly enforceable legal right to demand payment from the patient, the related revenue is only recognized upon cash receipt.
E stimates of amounts that we will ultimately realize require significant judgment by management. Some patients have out-of-pocket costs for amounts not covered by their insurance carrier, and we may bill the patient directly for these amounts in the form of co-payments and co-insurance in accordance with the patient’s health plan. Some payers may not cover the OVA1 test as ordered by the prescribing physician under their reimbursement policies. We pursue reimbursement from such patients on a case-by-case basis. In the absence of contracted reimbursement coverage or the ability to estimate the amount that will ultimately be realized for our services, revenue is recognized when cash is received.
There have been no other material changes to our critical accounting policies and estimates as disclosed in Item 7 of our Annual Report on Form 10-K for the fiscal year ended December 31, 201 5 .
19
Results of Operations - Three Months Ended March 31 , 201 6 Compared to Three Months Ended March 31 , 201 5
The selected summary financial and operating data of the Company for the three months ended March 3 1 , 201 6 and 201 5 were as follows:
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|
|
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Three Months Ended March 31, |
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Increase (Decrease) |
|||||||
(dollars in thousands) |
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2016 |
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2015 |
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Amount |
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% |
|||
Revenue: |
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|
|
|
|
|
|
|
|
|
|
Product |
|
$ |
505 |
|
$ |
635 |
|
$ |
(130) |
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(20) |
License |
|
|
- |
|
|
316 |
|
|
(316) |
|
(100) |
Total revenue |
|
|
505 |
|
|
951 |
|
|
(446) |
|
(47) |
Cost of revenue: |
|
|
|
|
|
|
|
|
|
|
|
Product |
|
|
528 |
|
|
491 |
|
|
37 |
|
8 |
Total cost of revenue |
|
|
528 |
|
|
491 |
|
|
37 |
|
8 |
Gross profit |
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|
(23) |
|
|
460 |
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(483) |
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(105) |
Operating expenses: |
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|
|
|
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|
Research and development |
|
|
934 |
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|
1,105 |
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(171) |
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(15) |
Sales and marketing |
|
|
2,280 |
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|
2,217 |
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|
63 |
|
3 |
General and administrative |
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|
1,659 |
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|
1,400 |
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|
259 |
|
19 |
Total operating expenses |
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|
4,873 |
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|
4,722 |
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|
151 |
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3 |
Loss from operations |
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|
(4,896) |
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|
(4,262) |
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|
(634) |
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15 |
Interest income |
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|
3 |
|
|
9 |
|
|
(6) |
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(67) |
Other expense, net |
|
|
(4) |
|
|
116 |
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|
(120) |
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(103) |
Net loss |
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|
(4,897) |
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|
(4,137) |
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|
(760) |
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18 |
Product Revenue . Product revenue was $ 505 ,000 for the three months ended March 3 1 , 201 6 compared to $ 635 ,000 for the same period in 201 5 . However, p roduct revenue for the three months ended March 31 , 2015 included the one-time recognition of $163,000 in deferred product revenue upon the signing of our new agreement with Quest Diagnostics on March 11, 2015 .
The number of OVA1 tests performed decreased 40 % to approximately 2 , 265 OVA1 tests during the three months ended March 31 , 201 6 compared to approximately 3 , 78 3 OVA1 tests for the same period in 201 5 . Th e volume during the three months ended March 3 1 , 201 5 included 3,567 OVA1 tests performed by Quest Diagnostics . All tests for the three months ended March 31, 2016 were performed by ASPiRA LABS. The decrease is attributed to volume loss incurred in the transition of testing from Quest Diagnostics to ASPiRA LABS in August 2015.
We expect product revenue to in crease modestly in the second quarter of 201 6 due to improved cash collections at ASPiRA LABS . Revenue for ASPiRA LABS ’ contractual clients is being recognized when the OVA1 test is performed. All other ASPiRA LABS revenue is being recognized on the cash basis and thus recognition of revenue lags behind the performance of an OVA1 test.
License Revenue . There was no license revenue recognized for the three months ended March 31 , 201 6 compared to $ 316 ,00 0 for the same period in 2015 . We do not expect to recognize any license revenue in future quarters.
Cost of Revenue . Cost of product revenue was $ 528 ,000 for the three months ended March 31 , 201 6 compared to $ 491 ,000 for the same period in 201 5 . The $ 37 ,000 , or 8 % , in crease is related to costs associated with processing the full volume of OVA1 tests at ASPiRA LABS after the cutover of volume from Quest Diagnostics to ASPiRA LABS on August 10 , 2015 . We expect the cost of revenue to remain consistent in the second quarter of 2016 .
Research and Development Expenses . Research and development expenses represent costs incurred to develop our technology and carry out clinical studies, and include personnel-related expenses, regulatory costs, reagents and supplies used in research and development laboratory work, infrastructure expenses, contract services and other outside costs. Research and development expenses also include costs related to activities performed under
20
contracts with our collaborators and strategic partners. Research and development expenses for the three months ended March 31 , 2016 de creased $ 171 ,000, or 15 % , compared to the same period in 201 5 . This de crease was primar ily due to a one-time product development consulting project in 2015 not being repeated in 2016 . We expect research and development expense to remain consistent in the second quarter of 2016 and until launch of our new clinical registry study.
Sales and Marketing Expenses . Our sales and marketing expenses consist primarily of personnel-related expenses, education and promotional expenses, and infrastructure expenses. These expenses include the costs of educating physicians, laboratory personnel and other healthcare professionals regarding OVA1. Sales and marketing expenses also include the costs of sponsoring continuing medical education, medical meeting participation, and dissemination of scientific and health economic publications. Sales and marketing expenses increased $ 6 3 ,000, or 3 %, for the three months ended March 3 1 , 201 6 compared to the same period in 201 5 . The increase was due to severance costs incurred in our February 2016 restructuring. We expect sales and marketing expenses to decrease in future quarters as a result of the restructuring effort.
General and Administrative Expenses . General and administrative expenses consist primarily of personnel-related expenses, professional fees and other costs, including legal, finance and accounting expenses and other infrastructure expenses. General and administrative expenses in creased by $ 25 9 ,000, or 19 %, for the three months ended March 31 , 2016 compared to the same period in 2015 . The in crease was primarily due to a $140,000 investment in our new IVD t rial services laboratory and increased consulting fees in 2016 compared to the same period in 2015 .
Other Income (Expense), Net . Other expense was $ 4 ,000 for the three months ended March 3 1 , 201 6 compared to other income of $ 116 ,000 in the same period in 2 01 5 . Other income for the three months ended March 31 , 201 5 related to recognition of one-time items related to the March 11, 2015 agreement with Quest Diagnostics.
Liquidity and Capital Resources
We plan to continue to expend resources in the selling and marketing of OVA1 and Overa and developing additional diagnostic tests and service capabilities .
We have incurred significant net losses and negative cash flows from operations since inception. At March 31 , 201 6 , we had an accumulated deficit of $ 375 , 48 5 ,000 and stockholders’ equity of $ 12 , 87 7 ,000 . As of March 3 1 , 201 6 , we had $ 1 3 , 06 7 ,000 of cash and cash equivalents and $ 2 , 9 40 ,000 of current liabilities. Working capital was $ 10,9 9 1 ,000 and $ 16 , 015 ,000 at March 3 1 , 201 6 and December 31, 201 5 respectively.
O n March 22, 2016, we entered into an agreement pursuant to which we may borrow up to $4,000,000 from the DECD. We received an initial disbursement of $2,000,000 on April 15, 2016 under this agreement . The remaining $2,000,000 will be disbursed if and when we achieve certain future milestones.
We expect to incur a net loss and negative cash flows from operations in 2016 and the foreseeable future. Our management believes that successful achievement of our business objectives will require additional financing. Given these conditions, there is substantial doubt about our ability to continue as a going concern. The condensed consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from these uncertainties.
We expect to raise capital through a variety of sources, which may include the public equity market, private equity financing, collaborative arrangements, licensing arrangements, and/or public or private debt. However, additional funding may not be available when needed or on terms acceptable to us . If we are unable to obtain additional capital, we may not be able to continue sales and marketing, research and development, or other operations on the scope or scale of current activity and that could have a material adverse effect on our business, results of operations and financial condition.
Net cash used in operating activities was $ 4, 99 5 ,000 for the three months ended March 31 , 201 6 resulting primarily from the net loss reported of $ 4,89 7 ,000 a nd changes in accounts payable, accrued and other liabilities of
21
$413,000 partially offset by stock compensation expense of $ 223,000 and depreciation and amortization of $147,000 .
Net cash used in operating activities was $4,525,000 for the three months ended March 31, 2015 resulting primarily from the net loss reported of $4,137,000 and non-cash license revenue of $316,000.
Net cash used in investing activities was $ 57 8 ,000 and $ 37 ,000 for the three months ended March 31 , 201 6 and 201 5 , respectively . This increase resulted primarily from purchases of property and equipment.
Net cash used in financing activities of $ 2 ,000 for the t hree months ended March 31, 2016 resulted from repayments of capital lease obligations which were partially offset by proceeds received from the exercise of stock options . Net cash used in financing activities for the three months ended March 31, 2015 resulted from the repayment of short-term debt of $1,069,000 and offering expenses incurred of $93,000.
Our future liquidity and capital requirements will depend upon many factors, including, among others:
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resources devoted to sales, marketing and distribution capabilities; |
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· |
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the rate of product adoption by physicians and patients; |
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· |
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the insurance payer community’s acceptance of and reimbursement for OVA1 and Overa ; |
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· |
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the successful launch of O vera ; |
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· |
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resources devoted to our IVD trials laboratory and services; |
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· |
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our plans to acquire or invest in other products, technologies and businesses; and |
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the market price of our common stock. |
We have significant net operating loss (“NOL”) carryforwards as of March 31 , 201 6 for which a full valuation allowance has been provided due to our history of operating losses. Our ability to use our net NOL credit carryforwards may be restricted due to ownership change limitations occurring in the past or that could occur in the future, as required by Section 382 of the Internal Revenue Code of 1986, as amended, as well as similar state provisions. These ownership changes may also limit the amount of NOL credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively.
Off-Balance Sheet Arrangements
As of March 3 1 , 201 6 , we had no off-balance sheet arrangements that are reasonably likely to have a current or future material effect on our condensed consolidated financial condition, results of operations, liquidity, capital expenditures or capital resources.
Per Item 305(e) of Regulation S-K, information is not required.
Evaluation of disclosure controls and procedures.
Our senior management is responsible for establishing and maintaining a system of disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Management, including our Chief Executive Officer and Chief Accounting
22
Officer, performed an evaluation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of March 31 , 201 6 . Based on this evaluation, our Chief Executive Officer and Chief Accounting Officer have concluded that as of March 3 1 , 201 6 , our disclosure controls and procedures were effective.
Changes in internal controls over financial reporting.
There was no change in our internal control over financial reporting that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
23
PART II - OTHER INFORMATION
In the ordinary course of business, we may periodically become subject to legal proceedings and claims arising in connection with ongoing business activities. The results of litigation and claims cannot be predicted with certainty, and unfavorable resolutions are possible and could materially and adversely affect our results of operations, cash flows and financial position. In addition, regardless of the outcome, litigation could have an adverse impact on us because of defense costs, diversion of management resources and other factors. While the outcome of these proceedings and claims cannot be predicted with certainty, there are no matters, as of March 31 , 201 6 , that, in the opinion of management, will have a material adverse effect on our financial position, results of operations or cash flows.
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There have been no material changes to our risk factors from those disclosed under “Risk Factors” in Part I, Item 1A of our 201 5 Annual Report except as set forth below. The risks and uncertainties described below and in our 201 5 Annual Report are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also materially adversely affect our business, financial condition or results of operations.
Additional Risk Factors
We are adding the following to the “Risks Related to Our Business” contained in our 201 5 Annual Report:
Risks Related to our planned ASPiRA IVD Business
ASPiRA IVD is a new business venture with no operating history and may subject us to additional risks.
To date, we have no operating results with respect to providing IVD trial services to third parties through ASPiRA IVD, and, therefore, we do not have an operating history upon which you can evaluate this new line of business or its prospects. Cash in-flows from our new IVD trial services business may not meet expectations, and ASPiRA IVD’s prospects must be considered in light of the risks and uncertainties inherent in entering into a new line of business, including:
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the potential diversion of management’s attention and other resources away from our existing business; |
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· |
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our relative inexperience with respect to offering IVD trial services; |
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· |
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external factors, such as compliance with regulations, competitive alternatives and shifting market preferences; |
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· |
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the need for additional capital and other resources to expand our IVD trial services business; and |
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· |
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its impact on our system of internal controls. |
Failure to successfully manage these risks in the development and implementation of ASPiRA IVD’s new IVD trial services business could have an adverse effect on our business, financial condition and results of operations.
24
The success of ASPiRA IVD depends on our ability to generate and maintain new business awards and contracts, and if we fail to do so, it could adversely affect our business, financial condition and results of operations.
The success of ASPiRA IVD depends on our ability to generate new business awards and new customers and contracts for clinical development services and other services. The time between when a study is awarded and when it goes to contract can be several months, and prior to a new business award going to contract, our potential customers will be able to cancel the award without notice. We expect that, once an award goes to contract, the majority of our customers will be able to terminate the contract with 30 days' notice. Our IVD contracts may be delayed or terminated by our customers or reduced in scope for a variety of reasons beyond our control, including the following:
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decisions to forego or terminate a particular trial; |
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· |
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budgetary limits or changing priorities; |
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· |
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actions by regulatory authorities; |
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· |
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production problems resulting in shortages of the drug or device being tested; |
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· |
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failure of products being tested to satisfy safety requirements or efficacy criteria; |
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· |
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unexpected or undesired clinical results for products; |
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· |
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insufficient patient enrollment in a trial; |
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· |
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insufficient principal investigatory recruitment; |
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· |
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shift of business to a competitor or internal resources; or |
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· |
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product withdrawal following market launch. |
As a result, we expect that contract terminations, delays and modifications will be a regular part of ASPiRA IVD’s business. In the event of termination, ASPiRA IVD’s contracts will provide for fees for winding down the project, which include both fees incurred and actual and non-cancellable expenditures, and may also include a fee to cover a percentage of the remaining professional fees on the project. These fees may not be sufficient for us to maintain our margins, and termination may result in lower resource utilization rates and therefore lower operating margins. Cancellation of a clinical trial may also result in the unwillingness or inability of our customer to satisfy certain associated accounts receivable. Additionally, a change in the timing of a new business award could affect the period over which we recognize revenue and reduce our revenue in any one quarter. If ASPiRA IVD is unable to generate new business awards on a timely basis and subsequently enter into and maintain contracts for such awards, our business, financial condition and results of operations could be adversely affected.
Operating results for ASPiRA IVD may fluctuate significantly between fiscal quarters, which may adversely affect the market price of our stock.
Operating results for ASPiRA IVD may fluctuate significantly from quarter to quarter and may be influenced by a variety of factors, such as:
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timing of contract amendments for changes in scope that could affect the value of a contract and potentially impact the amount of net new business awards and net service revenues from quarter to quarter; |
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commencement, completion, execution, postponement or termination of large contracts; |
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contract terms for the recognition of revenue milestones; |
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progress of ongoing contracts and retention of customers; |
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changes in the mix of services we are contracted to perform; and |
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potential customer disputes, penalties, or other issues that may impact the revenue we are able to recognize or the collectability of our related accounts receivable. |
ASPiRA IVD’s operating results for any particular quarter will not necessarily be a meaningful indicator of its future results. The resulting fluctuations in the Company’s quarterly operating results could negatively affect the market price and liquidity of shares of our common stock.
25
If we underprice our IVD contracts, overrun our IVD cost estimates or fail to receive approval for or experience delays in documentation of IVD change orders, it could adversely affect our business, financial condition and results of operations.
We plan to price our IVD contracts based on assumptions regarding the scope of work required and cost to complete the work. We will bear the financial risk if we initially underprice our contracts or otherwise overrun our cost estimates, which could adversely affect ASPiRA IVD’s cash flows and financial performance. In addition, we anticipate that contracts with ASPiRA IVD’s customers will be subject to change orders, which may occur when the scope of work we perform needs to be modified from that originally contemplated in our customer contracts. This can occur, for example, when there is a change in a key study assumption or parameter or a significant change in timing. We may be unable to successfully negotiate changes in scope or change orders on a timely basis or at all, which may require us to incur cost outlays ahead of the receipt of any additional revenue. In addition, under generally accepted accounting principles in the United States of America we will not be able to recognize additional revenue anticipated from change orders until appropriate documentation is received by us from the customer authorizing the change. However, if we incur additional expense in anticipation of receipt of that documentation, we will need to recognize the expense as incurred. Any of the foregoing could adversely affect our business, financial condition and results of operations.
The operation of ASPiRA IVD will depend on the effectiveness and availability of our information systems, including the information systems we use to provide services to our customers and to store employee data, and failures of these systems, including in connection with cyber-attacks, may materially limit our operations or have an adverse effect on our reputation.
The information systems we intend to use for our IVD trial business are comprised of systems we have purchased or developed, legacy information systems from Vermillion and, increasingly, web-enabled and other integrated information systems. In using these information systems, we may rely on third-party vendors to provide hosting services, where our infrastructure is dependent upon the reliability of their underlying platforms, facilities and communications systems. We also plan to utilize integrated information systems that we provide customers access to or install for our customers in conjunction with our delivery of services.
As the breadth and complexity of ASPiRA IVD’s information systems grows, we will increasingly be exposed to the risks inherent in maintaining the stability of our legacy systems due to prior customization, attrition of employees or vendors involved in their development, and obsolescence of the underlying technology as well as risks from the increasing number and scope of external data breaches on companies generally. Because certain customers and clinical trials may be dependent upon these legacy systems, we will also face an increased level of embedded risk in maintaining the legacy systems and limited options to mitigate such risk. We are also exposed to risks associated with the availability of all of our information systems, including:
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disruption, impairment or failure of data centers, telecommunications facilities or other key infrastructure platforms, including those maintained by third-party vendors; |
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security breaches of, cyber-attacks on and other failures or malfunctions in our internal systems, including our employee data and communications, critical application systems and their associated hardware; and |
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excessive costs, excessive delays and other deficiencies in systems development and deployment. |
The materialization of any of these risks may impede the processing of data, the delivery of databases and services, and the day-to-day management of our IV D trial business and could result in the corruption, loss or unauthorized disclosure of proprietary, confidential or other data. While we have disaster recovery plans in place in line with applicable regulations and industry standards , they might not adequately protect us in the event of a system failure. Despite any precautions we take, damage from fire, floods, hurricanes, the outbreak or escalation of war, acts of terrorism, power loss, telecommunications failures, computer viruses, break-ins and similar events at our various computer facilities or those of our third-party vendors could result in interruptions in the flow of data to us
26
and from us to our customers. Corruption or loss of data may result in the need to repeat a trial at no cost to the customer, but at significant cost to us, the termination of a contract or damage to our reputation. As our business continues its efforts to expand globally, these types of risks may be further increased by instability in the geopolitical climate of certain regions, underdeveloped and less stable utilities and communications infrastructure, and other local and regional factors. Additionally, significant delays in system enhancements or inadequate performance of new or upgraded systems could damage our reputation and harm our business. Although we carry property and business interruption insurance which we believe is customary for our industry, our coverage might not be adequate to compensate us for all losses that may occur.
Unauthorized disclosure of sensitive or confidential data, whether through systems failure or employee negligence, cyber-attacks, fraud or misappropriation, could damage our reputation and cause us to lose customers and, to the extent any such unauthorized disclosure compromises the privacy and security of individually identifiable health information, could also cause us to face sanctions and fines under the Federal Health Insurance Portability and Accountability Act of 1996 as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 . Similarly, we have been and expect that we will continue to be subject to attempts to gain unauthorized access to or through our information systems or those we internally or externally develop for our customers, including a cyber-attack by computer programmers and hackers who may develop and deploy viruses, worms or other malicious software programs, process breakdowns, denial-of-service attacks, malicious social engineering or other malicious activities, or any combination of the foregoing. In addition, we may be susceptible to physical or computer-based attacks by terrorists or hackers due to ASPiRA IVD’s role in the contract research organization industry. These concerns about security are increased when information is transmitted over the Internet. Threats include cyber-attacks such as computer viruses, worms or other destructive or disruptive software, and any of these could result in a degradation or disruption of our services or damage to our properties, equipment and data. They could also compromise data security. If such attacks are not detected immediately, their effect could be compounded. Successful attacks could result in negative publicity, significant remediation and recovery costs, legal liability and damage to our reputation and could have an adverse effect on our business, financial condition and results of operations.
If ASPiRA IVD fails to perform its services in accordance with contractual requirements, regulatory standards and ethical considerations, we could be subject to significant costs or liability and our business or reputation could be harmed.
We anticipate that ASPiRA IVD will contract with biopharmaceutical companies to perform a wide range of services to assist them in bringing new drugs to market. Our IVD trial services will include monitoring clinical trials, data and laboratory analysis, patient recruitment and other related services. Such services are complex and subject to contractual requirements, regulatory standards and ethical considerations. For example, ASPiRA IVD will be required to adhere to applicable regulatory requirements such as the FDA ’s Quality System Regulations, CLIA, and current Good Clinical Practices, which govern, among other things, the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials. If ASPiRA IVD fails to perform its services in accordance with these requirements, regulatory authorities may take action against us or our customers. Such actions may include sanctions (e.g., injunctions or the failure of such regulatory authorities to grant marketing approval of products), imposition of clinical holds or delays, suspension or withdrawal of approvals, rejection of data collected in studies conducted by ASPiRA IVD, license revocation, product seizures or recalls, operational restrictions, civil or criminal penalties or prosecutions, damages or fines. Additionally, there is a risk that actions by regulatory authorities, if they result in significant inspectional observations or other measures, could harm our reputation and cause customers not to award ASPiRA IVD future contracts or to cancel existing contracts. Any such action could have an adverse effect on our business, financial condition and results of operations.
27
Item 6. Exhibits
(a) The following exhibits are filed or incorporated by reference with this report as indicated below:
Pursuant to the requirements of the Securities Exchange Act of 1934 , the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Vermillion, Inc. |
Date: May 1 6 , 201 6 |
/s/ Valerie B. Palmieri |
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Valerie B. Palmieri President and Chief Executive Officer (Principal Executive Officer) |
Date: May 1 6 , 201 6 |
/s/ Eric J. Schoen |
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Eric J. Schoen Vice President, Finance and Chief Accounting Officer (Principal Financial Officer) |
29
ASSISTANCE AGREEMENT BY AND BETWEEN
THE STATE OF CONNECTICUT
ACTING BY THE DEPARTMENT OF ECONOMIC AND COMMUNITY DEVELOPMENT
(An Equal Opportunity Employer)
AND
VERMILLION, INC.
RE: Vermillion Relocation Project
This ASSISTANCE AGREEMENT (the “ Agreement ”) is made and entered into by and between the STATE OF CONNECTICUT , (hereinafter the “ State ”), acting herein by Catherine Smith, its Commissioner of Economic and Community Development, (hereinafter the “ Commissioner ”), pursuant to Chapter 588l of the Connecticut General Statutes and VERMILLION, INC. (hereinafter the “ Applicant ” or “ contractor ”) acting herein by Valerie P. Palmieri, its duly authorized President and CEO.
WITNESSETH:
WHEREAS , the governing body of the Applicant has submitted to the State a series of documents including an acceptance letter in response to a Letter of Intent submitted to it by the Commissioner dated August 4, 2015 as amended by letter March 2, 2016 (the “ Commissioner’s LOI ”), an Application for Financial Assistance, a resolution from the Applicant’s appropriate organizational body authorizing the Applicant to submit said Application, a Project Financing Plan and Budget, and exhibits, if any, and has caused to have submitted an Opinion of Counsel and other documents (all, together with all other documents and agreements executed by the Applicant in connection with this Agreement, hereinafter the “ Project Documents ”) for a project entitled Vermillion Relocation Project (hereinafter the “ Project ”) and has represented to the State that it can rely upon the information within the Project Documents as being accurate and complete;
WHEREAS , in reliance upon the information submitted by or caused to be submitted by the Applicant, the State has approved funding for the Project; and
WHEREAS , the State and the Applicant desire to define the terms and conditions upon which such financial assistance will be made available to the Applicant.
NOW THEREFORE , in consideration of the mutual promises of the parties hereto, and of the mutual benefits to be gained by the performance thereof, the State and the Applicant hereby agree as follows:
ARTICLE 1 - STATE OBLIGATIONS
1.1 Financial Assistance . The State hereby agrees, subject to the terms of this Agreement and its Exhibits and in reliance upon the facts and representations set forth in the Project Documents, to provide financial assistance to the Applicant for the Project in the form of
a loan in an amount not to exceed FOUR MILLION AND NO /100 DOLLARS ($4,000,000.00) (the “ Loan ”), which Loan shall be evidenced by a promissory note (hereinafter the “Funding”); provided, however, that the aggregate principal of the Funding shall not exceed fifty percent (50%) of the cost of the Project. The Applicant acknowledges that $2,000,000.00 of the Loan has been approved by the State of Connecticut Bond Commission (the “Commission”) but the additional $2,000,000.00 is subject to the approval of Commission which has not yet approved said additional $2,000,000.00 as of the date hereof. Therefore, the State’s obligation to fund $2,000,000.00 of the Loan amount is specifically conditioned upon such approval by the Commission.
1.2 Disbursement of the Loan:
A. The first $2,000,000.00 of the Loan shall be disbursed (i) upon the closing of this financial assistance; (ii) whenever the Applicants shall have established its operations in and taken occupancy of its Trumbull, Connecticut location at 35 Nutmeg Drive; and (iii) upon the Applicant providing evidence on its balance sheet showing at least $18,000,000.00 of additional capital investment.
B. Thereafter, $1,000,000.00 of the Loan shall be disbursed (i) after Commission approval per Section 1.1 above, (ii) after the Applicant shall have received approval from the Food and Drug Administration (FDA) for OVA 2 and (iii) upon verification by the State of the creation of 40 full time jobs prior to the Target date referred to in Section 2.17 infra.
C. The last remaining $1,000,000.00 balance of the Loan shall be disbursed after subsection B above is satisfied and the Applicant shall have achieved gross consolidated revenue of $5,000,000.00 for any trailing twelve (12) month period as reported in Applicants SEC filings.
1.3 Repayment of Loan. The Loan shall be repayable by the Applicant in accordance with the terms of the promissory note evidencing the Loan (the “ Note ”).
ARTICLE 2 - APPLICANT WARRANTIES, COVENANTS, AND OBLIGATIONS
The Applicant represents, warrants and covenants as follows, and further covenants that on and after the closing and for so long as this Agreement or any clause thereof shall remain in effect:
2.1 Form of Entity . The Applicant is a Delaware corporation duly created and validly existing, or properly registered to do business, under the laws of the State of Delaware and State of Connecticut and each other jurisdiction where the ownership of its property or the conduct of its business requires qualification. Further, that the Applicant will preserve and maintain its existence as a corporation duly organized validly existing, and in good standing under the laws of Texas, and will remain (or become) qualified to do business and in good standing in the State of Connecticut and in each other jurisdiction where the nature of its business or the ownership of its property makes such qualification necessary.
2.2 Ability to Conduct Business . The Applicant has all franchises, permits, licenses, and other similar authorizations necessary for the conduct of its business as now being conducted by it, and it is not aware of any state of facts that would make it impossible or impractical to obtain any similar authorization necessary for the conduct of its business as planned to be conducted. The Applicant is not in violation, nor will the transactions contemplated by the Agreement or the Project Documents to which it is a party, cause a violation of the terms or provisions of any such franchise, permit, license, or similar authorization.
2.3 Authorization to Enter Into and Execute Project Documents . The execution and delivery of the Project Documents and this Assistance Agreement by the Applicant, and the performance of its obligations thereunder, are within its power, have been duly authorized by all necessary action on its part, and are not in contravention of law nor in contravention of its organizational documents or governing bylaws or of the provisions of any indenture, agreement, or undertaking to which it, its principals or employees are parties or by which they are bound.
2.4 Other Authorization Unnecessary . No consent, license, or approval from any governmental authority is or will be necessary for the valid execution and delivery by the Applicant of the Project Documents. The Applicant agrees that nothing in the Agreement relieves it from any obligation under law to obtain any such license, consent, or approval.
2.5 Agreement to Undertake Project . The Applicant agrees to undertake and complete the Project as described in the Commissioner’s LOI.
2.6 Obstacles to Entering and Executing Project .
(A) Existing Suit or Other Actions . There is no action, suit, proceeding or investigation at law, in equity, or before any court, public board, arbitrator, or body, pending or, to the Applicant’s knowledge, threatened against or affecting it, which could or might adversely affect the Project, the State’s security as described in section 2.16 below, any of the transactions contemplated by the Project Documents or the validity of the Project Documents, or the Applicant’s ability to discharge its obligations under the Project Documents.
(B) Default of Existing Orders or Instruments . The Applicant is not in default beyond any applicable notice and grace periods with respect to any order of any court, arbitrator, or governmental body which could or might adversely affect the Project, the State’s security as described in section 2.16 below, or any of the transactions contemplated by the Project Documents or the validity of the Project Documents, or the Applicant’s ability to discharge its obligations under the Project Documents. In addition, the Applicant is not in default beyond any applicable grace periods in the performance, observance or fulfillment of any of the terms, obligations, covenants, conditions, or provisions contained in any agreement or instrument to which the Applicant is a party or to which its property is subject, which default, together with all such defaults, singularly or in the aggregate, may have a materially adverse effect on the business, assets, liabilities, financial condition, results of operations or business prospects of the Applicant.
(C) Instance of Default . No Instance of Default (as defined in section 4.1 hereof) has occurred or is continuing, and the Applicant has no knowledge of any currently existing facts or circumstances which, with the passage of time or the giving of notice, or both, would constitute an Instance of Default.
2.7 Material Adverse Change .
(A) Financial Condition . There has been no material adverse change in the financial condition of the Applicant or any Guarantor of this Agreement, if applicable, since the date of application for the Funding that has not been previously disclosed in writing to the Commissioner.
(B) Representations in Documents . All financial statements, including, without limitation, balance sheets and profit and loss statements, delivered to the Commissioner are correct and complete, and fairly present the financial position and results of operations of the Applicant at the times of and for the periods reflected by such financial statements. The financial statements and all other written statements furnished by the Applicant in connection with the Funding do not contain any untrue statement of material fact and do not omit any material fact whose omission would make the statements contained therein or herein misleading.
(C) Other Facts . There is no fact which the Applicant has not disclosed to the Commissioner in writing, which writing, if any, is attached hereto as Exhibit A , which materially and adversely affects or, as far as the Applicant can reasonably foresee, is reasonably likely to prove to affect materially and adversely the business, operations, properties, prospects, profits, or condition of the Applicant. Further, the Applicant will notify the Commissioner, in writing, promptly of any material adverse change in the financial condition or business prospects of the Applicant or any Guarantor of this Agreement.
2.8 Use of State Funding . The Funding shall be used for the Project as set forth in the Commissioner’s LOI and in accordance with the most recently approved Project Financing Plan and Budget. The Funding shall be used for that purpose and for no other purpose.
(A) Additional Costs above Funding . Any amount in excess of the amount of the Funding that may be necessary to cover the cost of the Project as set forth in the most recently approved Project Financing Plan and Budget shall be the responsibility of the Applicant and shall not be covered by the Funding. The Applicant shall, as a minimum, provide the level and sources of funding as indicated in the Project Documents, and shall expend those funds in accordance with the Project Financing Plan and Budget.
(B) Budget . The Project Financing Plan and Budget most recently approved by the Commissioner shall constitute the budget for the Project. The Project Financing Plan and Budget may be amended by request of the Applicant if such request is approved in writing by the Commissioner. Approval by the Commissioner of any revised Project Financing Plan and Budget shall not constitute or imply a revision of the amount of the Funding.
2.9 Payment of Other Obligations . The Applicant will pay and discharge promptly when due and payable all taxes, assessments and governmental charges levied or imposed upon it, its property, or any part thereof, or upon its income or profits, or any part thereof, as well as all lawful claims for labor, materials and supplies, which, if unpaid, might by law become a lien or charge upon its property, provided that such charges need not be paid while being contested by the Applicant in good faith and by appropriate legal proceedings so long as adequate book reserves have been established with respect thereto and the Applicant’s title to, and its right to use, its property is not materially and adversely affected thereby. The Applicant also agrees to pay all taxes or duties levied or assessed upon said sum against the State, the obligation evidenced hereby or the collateral securing the same and to pay all costs, expenses, and attorneys’ reasonable fees incurred by the State in any proceeding for the collection of the obligations evidenced hereby or in any action to enforce the State’s rights in property granted under the Security Agreement upon the happening of an Instance of Default as provided for in the Project Documents or in protecting or sustaining the lien granted in connection with this Agreement or in the Security Agreement or in any litigation or controversy arising from or connected with the Project Documents.
2.10 Compliance with Laws, Regulations, Rules, and Executive Orders. In the administration and execution of the Project, the Applicant shall comply with all pertinent provisions of local, State and Federal law applicable to it and/or its properties and/or its business, and maintain its property in good repair. Failure to do so shall constitute an Instance of Default by the Applicant under this Agreement. The Applicant agrees to provide each labor union or representative of workers with which such Applicant has a collective bargaining agreement or other contract or understanding and each vendor with which such Applicant has a contract or understanding, a notice to be provided by the Commission on Human Rights and Opportunities advising the labor union or workers’ representative of the Applicant’s commitments under this section, and to post copies of such notice in conspicuous places available to be seen by employees and applicants for employment.
Specifically, but not by way of limitation, the Applicant agrees to the following:
(A) For the purposes of subsection (B) of this section 2.10, the following terms are defined as follows:
1. “ Commission ” means the Commission on Human Rights and Opportunities;
2. “ Contract ” and “ contract ” means the Agreement and any extension or modification of the Agreement;
3. “ Contractor ” and “ contractor ” include any successors or assigns of the Contractor or contractor;
4. “ Gender identity or expression ” means a person’s gender-related identity, appearance or behavior, whether or not that gender-related identity, appearance or behavior is different from that traditionally associated with the person’s physiology or assigned sex at birth, which gender-related identity can be shown by providing evidence
including, but not limited to, medical history, care or treatment of the gender-related identity, consistent and uniform assertion of the gender-related identity or any other evidence that the gender-related identity is sincerely held, part of a person’s core identity or not being asserted for an improper purpose.
5. “ Good faith ” means that degree of diligence which a reasonable person would exercise in the performance of legal duties and obligations;
6. “ Good faith efforts ” shall include, but not be limited to, those reasonable initial efforts necessary to comply with statutory or regulatory requirements and additional or substituted efforts when it is determined that such initial efforts will not be sufficient to comply with such requirements;
7. “ Intellectual disability ” means a significant limitation in intellectual functioning and deficits in adaptive behavior that originated during the developmental period before eighteen years of age;
8. “ Marital status ” means being single, married as recognized by the State of Connecticut, widowed, separated or divorced;
9. “ Mental disability ” means one or more mental disorders, as defined in the most recent edition of the American Psychiatric Association’s “Diagnostic and Statistical Manual of Mental Disorders”, or a record of or regarding a person as having one or more such disorders;
10. “ Minority business enterprise ” means any small contractor or supplier of materials fifty-one percent or more of the capital stock, if any, or assets of which is owned by a person or persons: (1) who are active in the daily affairs of the enterprise, (2) who have the power to direct the management and policies of the enterprise, and (3) who are members of a minority, as such term is defined in subsection (a) of Connecticut General Statutes § 32-9n; and
11. “ Public works contract ” means any agreement between any individual, firm or corporation and the State or any political subdivision of the State other than a municipality for construction, rehabilitation, conversion, extension, demolition or repair of a public building, highway or other changes or improvements in real property, or which is financed in whole or in part by the State, including, but not limited to, matching expenditures, grants, loans, insurance or guarantees.
For purposes of subsection (B) of this section 2.10, the terms “ Contract ” and “ contract ” do not include a contract where each contractor is (a) a political subdivision of the state, including, but not limited to, a municipality, (b) a quasi-public agency, as defined in Conn. Gen. Stat. Section 1-120, (c) any other state, including but not limited to any federally recognized Indian tribal governments, as defined in Conn. Gen. Stat. Section 1-267, (d) the federal government, (e) a foreign government, or (f) an agency of a subdivision, agency, state or government described in the immediately preceding items (a), (b), (c), (d) or (e).
(B) (1) (a)The contractor agrees and warrants that in the performance of the Contract such contractor will not discriminate or permit discrimination against any person or group of persons on the grounds of race, color, religious creed, age, marital status, national origin, ancestry, sex, gender identity or expression, intellectual disability, mental disability or physical disability, including, but not limited to, blindness, unless it is shown by such contractor that such disability prevents performance of the work involved, in any manner prohibited by the laws of the United States or of the State of Connecticut; and the contractor further agrees to take affirmative action to insure that applicants with job-related qualifications are employed and that employees are treated when employed without regard to their race, color, religious creed, age, marital status, national origin, ancestry, sex, gender identity or expression, intellectual disability, mental disability or physical disability, including, but not limited to, blindness, unless it is shown by the contractor that such disability prevents performance of the work involved; (b) the contractor agrees, in all solicitations or advertisements for employees placed by or on behalf of the contractor, to state that it is an “affirmative action ‑equal opportunity employer” in accordance with regulations adopted by the Commission; (c) the contractor agrees to provide each labor union or representative of workers with which the contractor has a collective bargaining Agreement or other contract or understanding and each vendor with which the contractor has a contract or understanding, a notice to be provided by the Commission, advising the labor union or workers’ representative of the contractor’s commitments under this section and to post copies of the notice in conspicuous places available to employees and applicants for employment; (d) the contractor agrees to comply with each provision of this Section and Connecticut General Statutes §§ 46a-68e and 46a-68f and with each regulation or relevant order issued by said Commission pursuant to Connecticut General Statutes §§ 46a-56, 46a-68e and 46a-68f; and (e) the contractor agrees to provide the Commission on Human Rights and Opportunities with such information requested by the Commission, and permit access to pertinent books, records and accounts, concerning the employment practices and procedures of the contractor as relate to the provisions of this Section and Connecticut General Statutes § 46a-56. If the contract is a public works contract, the contractor agrees and warrants that he will make good faith efforts to employ minority business enterprises as subcontractors and suppliers of materials on such public works projects.
(2) Determination of the contractor’s good faith efforts shall include, but shall not be limited to, the following factors: The contractor’s employment and subcontracting policies, patterns and practices; affirmative advertising, recruitment and training; technical assistance activities and such other reasonable activities or efforts as the Commission may prescribe that are designed to ensure the participation of minority business enterprises in public works projects.
(3) The contractor shall develop and maintain adequate documentation, in a manner prescribed by the Commission, of its good faith efforts.
(4) The contractor shall include the provisions of subsection (1) of this section 2.10(B) in every subcontract or purchase order entered into in order to fulfill any obligation of a contract with the State and such provisions shall be binding on a subcontractor, vendor or manufacturer unless exempted by regulations or orders of the Commission. The contractor shall take such action with respect to any such subcontract or purchase order as the Commission may direct as a means of enforcing such provisions including sanctions for noncompliance in accordance with Connecticut General Statutes §46a-56; provided if such contractor becomes involved in, or is threatened with, litigation with a subcontractor or vendor as a result of such direction by the Commission, the contractor may request the State of Connecticut to enter into any such litigation or negotiation prior thereto to protect the interests of the State and the State may so enter.
(5) The contractor agrees to comply with the regulations referred to in this Section as they exist on the date of this Contract and as they may be adopted or amended from time to time during the term of this Contract and any amendments thereto.
(6) (a) The contractor agrees and warrants that in the performance of the Contract such contractor will not discriminate or permit discrimination against any person or group of persons on the grounds of sexual orientation, in any manner prohibited by the laws of the United States or the State of Connecticut, and that employees are treated when employed without regard to their sexual orientation; (b) the contractor agrees to provide each labor union or representative of workers with which such contractor has a collective bargaining Agreement or other contract or understanding and each vendor with which such contractor has a contract or understanding, a notice to be provided by the Commission advising the labor union or workers’ representative of the contractor’s commitments under this section, and to post copies of the notice in conspicuous places available to employees and applicants for employment; (c) the contractor agrees to comply with each provision of this section and with each regulation or relevant order issued by said Commission pursuant to Connecticut General Statutes § 46a-56; and (d) the contractor agrees to
provide the Commission with such information requested by the Commission, and permit access to pertinent books, records and accounts, concerning the employment practices and procedures of the contractor which relate to the provisions of this Section and Connecticut General Statutes § 46a-56.
(7) The contractor shall include the provisions of the foregoing subsection (6) of this section 2.10(B) in every subcontract or purchase order entered into in order to fulfill any obligation of a contract with the State and such provisions shall be binding on a subcontractor, vendor or manufacturer unless exempted by regulations or orders of the Commission. The contractor shall take such action with respect to any such subcontract or purchase order as the Commission may direct as a means of enforcing such provisions including sanctions for noncompliance in accordance with Connecticut General Statutes § 46a-56; provided, if such contractor becomes involved in, or is threatened with, litigation with a subcontractor or vendor as a result of such direction by the Commission, the contractor may request the State of Connecticut to enter into any such litigation or negotiation prior thereto to protect the interests of the State and the State may so enter.
(C) Executive Order No. Three. This Agreement is subject to the provisions of Executive Order No. Three of Governor Thomas J. Meskill promulgated June 16, 1971 and, as such, this Agreement may be cancelled, terminated or suspended by the State Labor Commissioner for violation or of noncompliance with said Executive Order No. Three, or any State or Federal Law concerning nondiscrimination, notwithstanding that the Labor Commissioner is not a party to this Agreement. The parties to this Agreement, as part of the consideration hereof, agree that said Executive Order No. Three is incorporated herein by reference and made a part hereof. The parties agree to abide by said Executive Order and agree that the State Labor Commissioner shall have continuing jurisdiction in respect to Agreement performance in regard to nondiscrimination, until the Agreement is completed or terminated prior to completion. The Applicant agrees as part consideration hereof, that this contract is subject to the guidelines and rules issued by the State Labor Commissioner to implement Executive Order No. Three and that it will not discriminate in its employment practices or policies, will file all reports as required, and will fully cooperate with the State and the State Labor Commissioner.
(D) Executive Order No. Sixteen . This Agreement is subject to, and Applicant hereby agrees to abide by Executive Order No. Sixteen of Governor John G. Rowland promulgated August 4, 1999, and, as such, the Agreement may be cancelled, terminated or suspended by the State for violation or noncompliance with said Executive Order No. Sixteen.
(E) Executive Order No. Seventeen. This Agreement is subject to the provisions of Executive Order No. Seventeen of Governor Thomas J. Meskill promulgated February 15, 1973, and, as such, this Agreement may be cancelled, terminated or suspended by the Commissioner or the State Labor Commissioner for violation of or noncompliance with said Executive Order No. Seventeen, notwithstanding that the Labor Commissioner may not be a party to this Agreement. The parties to this Agreement, as part of the consideration hereof, agree
that the Executive Order No. Seventeen is incorporated herein by reference and made a part hereof. The parties agree to abide by said Executive Order and agree that the contracting agency and the State Labor Commissioner shall have joint and several continuing jurisdiction in respect to Agreement performance in regard to listing all employment openings with the Connecticut Employment Service.
(F) Environmental Laws . The Applicant hereby agrees to indemnify and hold harmless the State from and against any liabilities, losses, damages, costs, or expenses, including attorney’s fees, arising out of or in connection with the presence of hazardous waste on or in any of the Collateral, as more fully described in section 2.16 below, or any lien or claim under Conn. Gen. Stat. section 22a-452a, as amended, or other federal, state, or municipal statute, regulation, rule, law, or proceeding relating to environmental matters, which indemnity shall survive, realization on any of the Collateral, as more fully described in section 2.16 below, payment in full of the Funding, and termination and/or release of the Project Documents.
(G) Relocation . The Applicant shall not relocate any material portion of its Trumbull, CT operations to a location outside of the State prior to the date that is ten (10) years after the Agreement Date or during the term of the Loan, whichever is longer (the “Non-Relocation Period”). If the Applicant relocates any of such operations within the State during such period, it shall offer employment at the new location to its employees from the original location if such employment is available. The Applicant shall provide written notification to the Commissioner of any proposed relocation prior to any public announcement.
If the Applicant, or its successors or assigns, relocates any of their applicable operations outside of Connecticut during the non-relocation period, the full amount of the financial assistance received, including any forgiveness provided, from the State, shall become immediately due and payable, plus a one-time penalty charge of 5.0% on the original amount of the financial assistance provided.
The applicant shall provide written notification to the Commissioner of DECD of its proposed relocation prior to any public announcement.
(H) Taxes . The Applicant has filed all federal, state, and municipal income and other tax returns which are required to be filed, and has paid, or made provision for the payment of, all taxes which have become due pursuant to said returns, except such taxes, if any, which are being contested in good faith and as to which adequate reserves have been provided.
(I) Campaign Contribution and Solicitation Prohibitions . For all State contracts as defined in C.G.S. sec. 9-612 having a value in a calendar year of $50,000 or more or a combination or series of such agreements or contracts having a value of $100,000 or more, the authorized signatory to this Agreement expressly acknowledges receipt of the State Elections Enforcement Commission’s notice advising state contractors of state campaign contribution and solicitation prohibitions, and will inform its principals of the contents of the notice. This notice is attached hereto as Exhibit C .
(J) General Indemnification . In addition to the specific covenants in subsection (F) of this section 2.10 above, the Applicant shall and hereby agrees to indemnify, defend, and hold the State, and its agents, officials, and employees, harmless from and against
any and all suits, damages, claims, causes of actions, demands, judgments, penalties, costs, expenses, attorneys’ fees, and any and all injuries to persons or property and all other matters arising out of or incurred in connection with the performance by Applicant of the terms, conditions, and covenants of this Agreement or in connection with the operation of the Project.
2.11 Other Debt . The Applicant will not, either directly or indirectly, except in the course of its ordinary business and in a manner which will not have a materially adverse impact on the Applicant’s ability to perform its obligations pursuant to the Agreement and the Project Documents, guarantee, endorse, become surety for, or otherwise be or become responsible for the obligations of any other person, whether by agreement to purchase the indebtedness of any other person, or agreement for the furnishing of funds to any other person, directly or indirectly, through the purchase of goods, supplies, (or by way of stock purchase, capital contribution, advance or loan) or for the purpose of paying or discharging the indebtedness of any other person or otherwise, except for the endorsement by the Applicant of negotiable instruments for collection in the ordinary course of business without the written consent of the Commissioner.
2.12 Conflict of Interest . The Applicant will adopt and enforce measures appropriate to assure that no member of the Applicant’s governing bodies and none of its officers or employees shall have or acquire voluntarily an interest in any agreement or proposed agreement in connection with the undertaking or carrying out of the Project.
2.13 Notification of Instance of Default by Applicant . The Applicant shall notify the Commissioner promptly of the occurrence of any material default hereunder or under any of the other Project Documents, or any other document, instrument or agreement to which the Applicant or its properties are subject and of the actions it intends to take in order to cure such default in a timely manner.
2.14 Business Continuation and Transfer of Control . (A) Except in connection with a Capital Event as set forth below, the Applicant shall not, either voluntarily or involuntarily, discontinue its business, be dissolved or otherwise suffer or permit any termination of its status as a business entity as described in Section 2.1 above, without the prior written consent of the Commissioner. No prior permission shall be required, however, in connection with a Capital Event as set forth below. No prior permission shall be required in connection with the transfer, sale or assignment of all or a material portion of its properties or assets to, or any merger or consolidation with, another entity (such transfer, sale, assignment, merger or consolidation shall be referred to herein as a “Transfer”) in the normal course of Applicant conducting its business, which is not likely to have a material adverse impact upon Applicant’s financial condition or its ability to perform under this Agreement, including, without limitation, maintaining the required employment levels. In such case, Applicant will provide the State with notice of any such Transfer, and even if such Transfer results in the assumption by the successor in interest entity of all liabilities and obligations hereunder and under the other Project Documents as a matter of law, the State shall have the right to require said successor entity to enter into assumption documents in form and substance satisfactory to the State.
(B) The Applicant shall provide the State with notice of any sale, merger or consolidation with another entity (each a “Capital Event”). If a Capital Event occurs, the Applicant shall provide the State with notice as to whether the successor in interest to the Applicant shall succeed to all of the rights and obligations of the Applicant provided for in this
Agreement and the other Project Documents. If the successor entity does not assume all liabilities and obligations under this Agreement and the other Project Documents, then the State shall have the right to deem the Capital Event to be a relocation of the Applicant to a location outside of Connecticut on the date of such Capital Event and therefore subject to the default remedies contained in this Agreement. Even if the Capital Event results in the assumption by the successor in interest entity of all liabilities and obligations hereunder and under the other Project Documents as a matter of law, the State shall have the right to require said successor entity to enter into assumption documents in form and substance satisfactory to the State.
2.15 Representations in Other Documents . All statements contained in any certificate, financial statement, legal opinion or other instrument delivered by or on behalf of the Applicant or any Guarantor pursuant to or in connection with this Agreement shall constitute representations and warranties made under this Agreement. All representations and warranties made under this Agreement shall be made at and as of the date of this Agreement, and at and as of the date of receipt of the Funding. All representations and warranties made under this Agreement shall survive the execution and delivery hereof and shall not be deemed to have been waived by any investigation made or not made by the State. The Project Documents to which the Applicant is a party, when delivered, will be legal, valid, and binding obligations of the Applicant, enforceable against it in accordance with their respective terms.
2.16 Security . The Applicant shall provide to the State as security for the Applicant’s obligations of repayment in respect of the Funding a first priority blanket lien on all of the Applicant’s existing Intellectual Property (as filed in the U S Patent office) and a first priority lien on all machinery and equipment purchased with the proceeds of the Funding having a value of at least $700,000.00 and to be located in the Applicant’s Trumbull business premises, pursuant to a security agreement executed of even date herewith (the “ Security Agreement ”), (hereinafter the “ Collateral ”) . The State agrees to subordinate its first priority lien on the Intellectual Property to the lien of an Institutional Lender (as hereinafter defined) of the Applicant after the closing. An Institutional lender shall mean any lender who does not have an equity interest in the Applicant and/or who is not acquiring an equity interest in the Applicant from a loan transaction to the Applicant. Upon the fulfillment of all obligations contained herein or in any of the Project Documents or upon the termination of the time period as required pursuant to section 2.10(G) whichever occurs last, and provided that no default has occurred or is continuing under the terms of this Agreement, any and all security interests provided to the State with respect to the Funding will be released.
2.17 Job Creation and Retention; Job Audit; Penalty; Forgiveness Credit .
(A) The Applicant will create and retain forty (40) full-time employment positions with an average annual salary of $85,000.00 i n Connecticut on or before March 1, 2018 (the “ Target Date ”, and shall maintain such positions for twenty-four (24) consecutive months (the “ Employment Obligation ”). A full-time employment position is defined as a position that is paid for a minimum of forty (40) hours per week. The twenty-four (24) consecutive month period ending on or before the Target Date that yields the highest annual average positions will be used to determine compliance with the Employment Obligation, provided that no portion of said twenty-four (24) consecutive months may begin before the Agreement Date.
(B) No later than sixty (60) days following the twenty-four-month period referenced in subsection (A) above, the Applicant shall furnish to the Commissioner a job audit, performed by a certified public accountant (“ CPA ”) in accordance with the DECD Audit Guide located at http://www.ct.gov/ecd/cwp/view.asp?a=1096&q=249676 (the “ Job Audit ”). If the Applicant has met its Employment Obligation earlier than required, it may make a written request for the Commissioner’s consent to have its Job Audit performed as of such earlier date, which consent shall not be unreasonably withheld. In such event, the Commissioner shall determine the due date of the Job Audit referred to herein. The Applicant’s employment numbers that are prior to the application date for the Loan shall not be considered as part of the Job Audit.
(C) If, as a result of the Job Audit, the Commissioner determines that the Applicant has failed to meet its Employment Obligation, the Applicant shall immediately repay a penalty of $100,000.00 per each full-time employment position below the Employment Obligation, if the total amount of the Funding is $4,000,000.00; $75,000.000 if the total amount of the Funding advanced is $3,000,000.00; and $50,000.00 if the total amount of the Funding advanced is $2,000,000.00. The amount repaid will be applied first to any outstanding fees, penalties or interest due, and then against the outstanding balance of the Funding. The Commissioner’s determination that a job penalty shall be imposed and the amount of the penalty shall be final.
(D) The Applicant may be eligible for a credit to be applied against the outstanding principal balance of the Loan (the “ Forgiveness Credit ”) in accordance with the following:
(i) If as a result of a Job Audit, the Commissioner determines that the Applicant has met its Employment Obligation and that the employment positions created and retained are at an average annual salary of not less than $80,750.00 (the “Threshold Salary”) (i.e. 95% or more of the “Baseline Salary” of Eighty Five Thousand and 00/100 Dollars ($85,000.00)) the Applicant may receive a credit in the amount of Two Million and 00/100 Dollars ($2,000,000.00) which will be applied against the then outstanding principal balance of the Loan. Upon application of the Forgiveness Credit, the Commissioner shall recalculate the monthly payments of principal and interest under the Note such that such monthly payments shall amortize the then remaining principal balance over the remaining term of the Note.
(ii) Notwithstanding the foregoing, if, as a result of the Job Audit conducted in accordance with this Section 2.17, the Commissioner determines that the Applicant has met its Employment Obligation but that the average annual salary of full-time employees created and retained is less than $80,750.00, any Forgiveness Credit for which the Applicant would otherwise be eligible to receive pursuant to Section 2.17(D)(i) above shall be reduced by a number equal to the result of the following formula: (the difference between the Baseline Salary and the actual average annual salary of new full-time employees) divided by the Baseline Salary, and multiplied by the Forgiveness Credit the Applicant is otherwise eligible to receive. For Example, if the Applicant met its Employment Obligation of 40 jobs created and retained for a period of twenty-four (24) consecutive months and, based on the Job Audit, it is determined that the Company had an actual annual salary of $75,000.00 per eligible employee, then the following would be the calculation for the reduction in the Forgiveness Credit: ($85,000.00-
$75,000.00)/$85,000.00 multiplied by $2,000,000.00 = $235,294.00. Therefore, the actual adjusted Forgiveness Credit would be $1,764,706 (i.e. $2,000,000.00 less $235,294.00).
ARTICLE 3 - PROJECT ADMINISTRATION
3.1 Records .
(A) Generally . The Applicant shall maintain records in a complete, businesslike manner, including full, accurate and current minutes and records of the Project in a form satisfactory to the Commissioner. The Applicant will furnish to the Commissioner or his designee, at such times as the Commissioner shall determine, any document, data, and information relating to the Project in possession of the Applicant which is requested by the Commissioner. The Commissioner, or his designee, shall, for the purpose of determining the proper disposition of the Funding, have the right at any time during normal business hours to inspect the minutes, records, books, files, documents, payrolls, employment contracts and conditions, contracts, and any other papers or electronic records of the Applicant, or to make inspection of any physical location of the Applicant. The Applicant shall aid and cooperate with any such inspection.
(B) Connecticut Department of Labor (“DOL”) Employment Data . The Applicant agrees that the State, acting through the Department of Economic and Community Development (“ DECD ”) may obtain directly from the DOL and disclose, as part of its reporting requirements to the Connecticut State Legislature and Auditors of Public Accounts, information pertaining to Applicant’s employment levels. The Applicant shall execute such consents as the Commissioner and/or DOL may require authorizing the Commissioner to obtain the Applicant’s employment records directly from DOL. The Applicant acknowledges and agrees that the information so obtained and disclosed may include employer name, address, and number of employees, by facility location, for the purpose of fulfilling DECD’s reporting requirements in accordance with section 32-1m of the Connecticut General Statutes, as may be amended or modified. Further, the Applicant agrees that this employment information may be utilized for purposes of performing employment audits and research-related activities conducted by DECD.
The Applicant also agrees that it will complete any form provided by DECD that is needed to assist in the completion of DECD’s annual consolidated report to the General Assembly as required under section 32-1m of the Connecticut General Statutes, as maybe amended or modified, if applicable.
3.2 Payment to Applicant . In order to permit the State to make payment to the Applicant with respect of the Funding, the Applicant agrees as follows:
(A) Office of the State Comptroller Electronic Fund Transfer Automated Clearing House (“ ACH ”)(EFT) Program . Upon the execution of this Agreement, the Applicant shall provide current, verifiable bank account information for accounts with Applicant’s bank to the Office of the State Comptroller (“ OSC ”) by submitting a completed Electronic Funds Transfer ACH (EFT) Election Form, available at http://www.osc.ct.gov/apd/eftprogram/ index.html, and such additional information as the OSC may require.
(B) Requisition Form . In order to bring about the transfer of moneys to the account designated under subsection (A) above (the “ Account ”), the Applicant shall requisition funds on forms provided by the Commissioner and in the manner prescribed by this Agreement. Payment to the Applicant will be made based upon said requisition forms.
(C) Pre-agreement Costs . Unless authorized by the Commissioner in writing, no costs incurred prior to date of the application for the Funding are eligible for payment from the Funding.
3.3 Insurance . Applicant shall maintain all required insurance in amounts, form, substance and quality acceptable to the State, as described more fully in Exhibit B , attached hereto and made a part hereof. A certificate evidencing such insurance shall be delivered to the Commissioner at the time of execution of this Agreement, and annually thereafter for the duration of the Agreement.
3.4 Personal Service Contracts . All Project cost items of personal service, except those to be performed by volunteers and those to be performed by employees of the Applicant who will not receive extra compensation for such service, shall be performed pursuant to a written contract, and the Applicant shall, upon request, provide the Commissioner with copies of all such contracts.
3.5 Inspections . The Commissioner shall from time to time, in his discretion, during regular business hours, have the right of making an inspection of the Collateral, and the Applicant shall assist the Commissioner in said inspection and shall make available such books and other records as the Commissioner may reasonably request.
3.6 Audit . Each Applicant subject to a federal and/or state single audit must have an audit of its accounts performed annually. The audit shall be in accordance with the DECD Audit Guide, located at http://www.ct.gov/ecd/cwp/view.asp?a=1096&q=249676, and the requirements established by federal law and state statute. All Applicants not subject to a federal and/or state single audit shall be subject to a Project-specific audit of its accounts within ninety (90) days of the completion of the Project or at such times as required by the Commissioner. Such audit shall be in accordance with the DECD Audit Guide. An independent public accountant as defined by generally accepted government auditing standards (GAGAS) shall conduct the audits. At the discretion and with the approval of the Commissioner, examiners from the Department of Economic and Community Development may conduct Project-specific audits.
3.7 Repayment to State . (a) Any unspent Funding shall become immediately due and payable by the Applicant to the State within ninety (90) days of the end date of the most recently approved Project Financing Plan and Budget. (b) In the event that an audit referred to in section 3.6 above demonstrates that the actual expenditures made by the Applicant in connection with the Project are less than the maximum allowable amounts for disbursement by the State, as set forth in section 1.1 above, any such excess disbursement made by the State in respect of the Funding shall become immediately due and payable by the Applicant to the State.
3.8 Yearly Reports . The Applicant shall furnish upon request to the State within ninety (90) days of the end of each of the Applicant’s fiscal year(s), or earlier as determined by the Commissioner for each year that this Agreement remains in effect: (1) its balance sheet and
the related statement of earnings and retained earnings, including all supporting schedules and comments, all of which shall be prepared by a certified public accountant of recognized standing using, at a minimum, the standards for a “ Review ” as that term is used in the reporting standards of the American Institute of Certified Public Accountants; and (2) such further financial and other information that the Commissioner may at his discretion require from time to time.
ARTICLE 4 - DEFAULT
4.1 Instances of Default . The occurrence of any of the following events shall constitute a default under this Agreement (an “Instance of Default”):
(A) Breach of Agreement . If the Applicant fails to perform any material act, duty, obligation or other agreement contained herein or in any other Project Document or fails to forebear from any unpermitted act, or if the Applicant abandons or terminates the Project, or takes such steps that such an abandonment or termination is imminent.
(B) Misrepresentation . If any representation or warranty made by the Applicant or caused to be made for the Applicant in any of the Project Documents prove at any time to be incorrect in any material respect.
(C) Unpaid Judgments . If a judgment or judgments for the payment of money shall be rendered against Applicant and any such judgment shall remain unpaid, unstayed on appeal, unbonded, undischarged or undismissed for a period of ninety (90) consecutive days.
(D) Receivership or Bankruptcy . If the Applicant shall: (i) apply for or consent to the appointment of a receiver, trustee or liquidator of all or a substantial part of any of its assets; (ii) be unable or admit in writing its inability to pay its debts as they mature; (iii) file or permit the filing of any petition or reorganization or the like under any insolvency or bankruptcy law, or the adjudication of it as a bankrupt, or make an assignment for the benefit of creditors or consent to any form of arrangement for the satisfaction, settlement or delay of debt or the appointment of a receiver for all or any part of its properties; or (iv) any action shall be taken by Applicant for the purpose of effecting any of the foregoing.
(E) Change in Business Structure . If the Applicant shall discontinue its business, dissolve or liquidate, or be dissolved or liquidated, or cease to legally exist, or merge or consolidate, or be merged or consolidated with or into any corporation or other business entity without the written consent of the Commissioner in violation of section 2.14 hereinabove.
(F) Condemnation or Seizure . If any Federal, state or local governmental instrumentality, body or agency shall condemn, seize or otherwise appropriate, or take custody or control of all or any substantial portion of the properties or assets of Applicant.
(G) Lack of Adequate Security . If the State, at any time and in good faith, deems itself to be insecure. For the purposes of this Agreement, the State shall be entitled to deem itself insecure when some event occurs, fails to occur or is threatened or some objective condition exists or is threatened which materially impairs the prospects of the Applicant’s business, which significantly impairs the value of the Collateral to the State, or which materially affects the financial condition or business operations of Applicant. Also included is the actual or
threatened waste, removal, or demolition of, or material alteration to, any significant part of the Applicant’s property.
(H) Cancellation of Insurance . Failure of the Applicant to keep in force all insurance required by this Agreement.
(I) Job Creation . Failure of the Applicant to meet its Employment Obligation and to pay the penalties associated therewith as set forth in section 2.17 hereinabove.
(J) Failure to Pay Debts . Failure of the Applicant to pay its debts as such debts become due if such failure could reasonably be anticipated to have a material adverse effect on the operations of the Applicant or on the Applicant’s ability to perform its obligations hereunder or under the other Project Documents. Failure to pay when due and payable the principal of or interest on or any other material amount owed with respect to any indebtedness for borrowed money upon which the Applicant is obligated to make payment, or the maturity of any such indebtedness shall have been accelerated in accordance with the provisions of any agreement or instrument providing for the creation of or concerning such indebtedness, or any event shall have occurred and be continuing after any applicable cure period which would permit any holder or holders of such indebtedness, any trustee or agency acting on behalf of such holder or holders or any other person so to accelerate such maturity if such failure could reasonably be anticipated to have a material adverse effect on the operations of the Applicant or on the Applicant’s ability to perform its obligations hereunder or under the other Project Documents.
(K) Violation of Terms in Other Project Documents . The occurrence of a default or violation under any of the Project Documents.
4.2 Events in Instances of Default .
(A) Notice of Default . If the Applicant defaults or shall commit or allow any breach of the Applicant’s covenants, agreements and other obligations under this Agreement, material or otherwise, including, without limitation, an Instance of Default hereunder, the Commissioner shall notify the Applicant of the default in writing (“Notice of Default”).
(B) Opportunity to Cure . Upon the occurrence of an Instance of Default, the Commissioner may determine that permitting an opportunity to cure a default could jeopardize the Project or security, or would not be in the best interests of the State. Under those circumstances, no opportunity to cure need be given and the Commissioner may seek other remedies. Without in any way limiting the preceding right to act without providing the opportunity to cure, the Commissioner may provide the Applicant thirty (30) days after the Notice of Default, or such longer period of time as the Commissioner may determine and set forth in writing, to cure or remedy the default or breach. Said cure or remedy will not be effective unless accepted, in writing, by the Commissioner.
(C) Remedies . Upon the occurrence of an Instance of Default and after any applicable grace period, the State, acting by the Commissioner, shall have, to the full extent permitted by law, each and all of the following remedies in addition to those provided for in other portions of this Agreement:
(1) To suspend all further payments by the State to the Applicant until such default is cured to the satisfaction of the Commissioner;
(2) To proceed to enforce the performance or observance of any obligations, agreements, or covenants of the Applicant or any Guarantor in this Agreement or the Project Documents;
(3) To declare the entire amount of the Funding to be immediately due and payable and to bring any and all actions at law or in equity as may be necessary to enforce said obligation of repayment. In such Instances of Default, the Applicant hereby agrees to repay immediately the entire unpaid principal amount of the Loan received (including any Forgiveness Credit provided hereunder) with any accrued and unpaid interest, and the entire amount of the Grant and liquidated damages equal to five percent (5%) of the total amount of the Funding received.
(4) The right to a writ of mandamus, injunction or similar relief against the Applicant or any or all of the members of the Applicant’s governing body, or against the officers, agents or representatives of the Applicant, as may be appropriate, because of such default or breach;
(5) The right to maintain any and all actions at law or suits in equity, including receivership or other proper proceedings, to cure or remedy any defaults or breaches of covenants under this Agreement;
(6) The State may collect a “late charge” not to exceed an amount equal to five percent (5%) of any installment of interest or principal or both which is not paid within fifteen (15) days of the date on which said payment is due. Late charges shall be separately charged to and collected from the Applicant and shall be due upon demand by the State;
(7) The State may collect costs associated with collection efforts as outlined in section 2.9 of this Agreement.
ARTICLE 5 - MISCELLANEOUS PROVISIONS
5.1 Non-waiver . If the State does not exercise, or delays in exercising, or exercises in part any of the State’s rights and remedies set forth in this Agreement for the curing or remedying of any default or breach of covenant or condition, or any other right or remedy, in no event shall such non ‑exercise, delay or partial exercise be construed as a waiver of full action by the State or a waiver of any subsequent default or breach of covenant or condition. Nothing in this Agreement may be construed as a waiver or limitation by the Commissioner of the State’s sovereign immunity.
5.2 Severance . If any court determines any provision or provisions of this Agreement to be invalid, the remainder of this Agreement shall not be thereby affected.
5.3 Agreement Date . This Agreement shall become effective as of the date the Commissioner or his designee affixes his signature hereto.
5.4 Originals . This Agreement shall be executed in three (3) counterparts, each of which shall be deemed an original, but which together shall constitute one and the same instrument.
5.5 Multiple Applicants . If there is more than one Applicant, the obligations hereunder and under the Project Documents, shall be joint and several.
5.6 Notices . Any notice to the Applicant pursuant hereto or pursuant to any of the Project Documents may be served in person or by mail. Any such requirement shall be deemed met by any written notice personally served at the principal place of business of the Applicant, or at such other address as the Applicant shall notify the Commissioner, or mailed by depositing it in any post office station or letter box enclosed in a postage-paid envelope addressed to the Applicant at 12117 Bee Caves Road, Building III, Suite 100, Austin, Texas 78738, or at such other address as provided above. Any notice to the State, Department, or Commissioner shall be addressed to the Commissioner at 505 Hudson Street, Hartford, CT 06106. Any notice served upon the State, Department, or Commissioner under this Agreement or any other Project Document shall be effective only upon receipt by the Commissioner.
5.7 Waivers by Applicant . The Applicant and all others who may become liable for all or any part of this obligation do hereby waive demand, presentment for payment, protest, notice of protest and notice of non ‑payment of this Agreement and do hereby consent to any number of renewals or extensions of the time of payment hereof and agree that any such renewals or extensions may be made without notice to any of said parties and without affecting their liability herein and further consent to the release of any part or parts or all of the security for the payment hereof and to the release of any party or parties liable hereon, all without affecting the liability of the other persons, firms or corporations liable for the payment of this Agreement.
5.8 Gender, Number and Captions . The use of a personal pronoun shall refer to all persons regardless of the proper grammatical term; the singular includes the plural; and, captions for sections are included only for reference and do not modify or effect the terms, conditions and provisions of any document, agreement or instrument.
5.9 Modification and Subordination . This Agreement may not be modified or amended in any manner except in a written agreement executed by all of the parties hereto. The State hereby acknowledges that the Applicant may enter into l financings in the normal course of its business and in connection with the same, Applicant may grant a security interest in the Intellectual Property. In the event that a lender of the Applicant requires a consent or subordination agreement from the State of its interests in such Intellectual Property, the State agrees to furnish such consent or subordination agreement in a form reasonably acceptable to the State. In the event that the Applicant seeks modification in the form of a consent or a subordination to financing required by the Applicant in its normal course of business, the
Applicant shall request such modification in writing to the Commissioner not less than thirty (30) days prior to the date such modification or subordination is required. The Applicant shall promptly reimburse the State for expenses, including reasonable attorneys’ fees, incurred in negotiating and entering into such modification.
5.10 Provision of Other Documents . Upon the request of the Commissioner, the Applicant shall execute and deliver or cause to be executed and delivered such further documents and instruments and do such further acts and things as the Commissioner may request in order to effectuate more fully the purposes of this Project, to secure more fully the payment of the Funding in accordance with its terms, and to vest more completely in and assure to the Commissioner its rights under the Project Documents. Without limiting the generality of the foregoing, the Applicant will join with the Commissioner in executing such financing statements, agreements, notices or other documents or instruments as the Commissioner shall deem necessary or desirable to create, preserve, protect, maintain or enforce its rights and interests in and its liens on the property of the Applicant. The Applicant shall pay the cost of filing and recording, or refiling and re-recording, such documents and instruments in all public offices in which such filing or recording, or refiling or re-recording, is deemed by the Commissioner to be necessary or desirable.
5.11 Assignment . This Agreement and any of the documents related hereto and the rights, duties, or obligations thereunder may not be assigned by the Applicant without the written consent of the Commissioner. Any assignment made without the written consent of the Commissioner shall be void and of no force or effect.
5.12 Survival of Representations, Warranties and Covenants . For the purposes of this Agreement, the term “Applicant” shall mean and include any successor or assigns of Applicant including any representative of Applicant under the provisions of any state or Federal law governing bankruptcy, insolvency, receivership or reorganization. All representations, warranties , and covenants made by the Applicant in this Agreement or in any of the other Project Documents or in any certificate or instruments delivered to the State in connection with the Funding shall be considered to have been relied upon by the Commissioner and shall survive until the expiration of the term of this Agreement in accordance with section 5.19(A) hereof . This Agreement and the other Project Documents shall be binding upon and inure to the benefit of the successors and assigns of each of the parties; provided, however, that nothing in this provision shall imply that the Applicant has the right or authority to assign its rights, duties or obligations hereunder or under any of the Project Documents without the written consent of the Commissioner.
5.13 Governing Documents . In the event of any conflict between this Agreement and any of the Project Documents, this Agreement shall be controlling.
5.14 Third Parties . This Agreement is between the State and the Applicant only and shall not be relied upon by any third party.
5.15 Governing Laws . The laws of the State of Connecticut shall govern this Agreement and the Project Documents.
5.16 Jurisdiction . The Applicant agrees that the execution of the Agreement and the other Project Documents, and the performance of its obligations hereunder and thereunder, shall be deemed to have a Connecticut situs, and the Applicant shall be subject to the personal jurisdiction of the courts of the State of Connecticut with respect to any action the Commissioner, his successors or assigns may commence hereunder or thereunder. Accordingly, the Applicant hereby specifically and irrevocably consents to the jurisdiction of the courts of the State of Connecticut with respect to all matters concerning this Agreement or any of the other Project Documents or the enforcement thereof in any action initiated by the Commissioner or which the Commissioner voluntarily joins as a party.
5.17 Commercial Transaction and Waiver . THE APPLICANT AGREES THAT THE TRANSACTION OF WHICH THIS AGREEMENT IS A PART IS A COMMERCIAL TRANSACTION AND WAIVES ANY RIGHT TO NOTICE, PRIOR HEARING, AND ANY OTHER RIGHTS IT MAY HAVE UNDER CHAPTER 903a OF THE CONNECTICUT GENERAL STATUTES, AS MAY BE AMENDED, OR OTHER APPLICABLE LAW WITH RESPECT TO ANY REMEDY WHICH THE STATE MAY DESIRE TO USE, AND THE COMMISSIONER MAY INVOKE ANY PREJUDGMENT REMEDY AVAILABLE TO HIM, INCLUDING, BUT NOT LIMITED TO, GARNISHMENT, ATTACHMENT, FOREIGN ATTACHMENT AND REPLEVIN, WITH RESPECT TO ANY TANGIBLE OR INTANGIBLE PROPERTY (WHETHER REAL OR PERSONAL) OF THE APPLICANT TO ENFORCE THE PROVISIONS OF THE PROJECT DOCUMENTS, WITHOUT GIVING THE APPLICANT ANY NOTICE OR OPPORTUNITY FOR A HEARING.
5.18 Jury Trial Waiver . THE APPLICANT HEREBY WAIVES TRIAL BY JURY IN ANY COURT IN ANY SUIT, ACTION OR PROCEEDING OR ANY MATTER ARISING IN CONNECTION WITH OR IN ANY WAY RELATED TO THE TRANSACTION OF WHICH THIS AGREEMENT IS A PART AND/OR THE ENFORCEMENT OF ANY OF ITS RIGHTS AND REMEDIES. THE APPLICANT ACKNOWLEDGES THAT IT MAKES THIS WAIVER KNOWINGLY, VOLUNTARILY AND ONLY AFTER CONSIDERATION OF THE RAMIFICATIONS OF THIS WAIVER WITH ITS ATTORNEY.
5.19 Expiration or Termination of Agreement.
(A) The term of this Agreement shall expire upon the later to occur of the following events: (i) the expiration of the Non-Relocation Period; or (ii) repayment in full of the Loan in accordance with the terms hereof and in all other Project Documents.
(B) Notwithstanding subsection (A) above, the Applicant may terminate this Agreement prior to the expiration of the Non-Relocation Period so long as it makes full repayment of the Funding, including any Forgiveness Credit provided hereunder, less payments of principal paid in respect of the Loan, plus liquidated damages equal to five percent (5.0%) of the total amount of the Funding received, plus all costs and expenses related thereto .
(C) Notwithstanding any such expiration or termination of this Agreement, all indemnity rights set forth in Section 2.10(J) and elsewhere in this Agreement or in any of the other Project Documents shall survive such expiration or termination.
ARTICLE 6 - SPECIAL CONDITIONS: NONE
[Remainder of Page Intentionally Left Blank]
IN WITNESS WHEREOF , the parties hereto make and enter into this Agreement.
VERMILLION, INC.
By: /s/ Valerie B. Palmieri
Name: Valerie B. Palmieri
Title: President and CEO
Duly Authorized
Dated: 3/14/16
STATE OF CONNECTICUT
DEPARTMENT OF ECONOMIC
AND COMMUNITY DEVELOPMENT
By: /s/ Catherine H. Smith
Catherine H. Smith
Commissioner
Duly Authorized
Dated: 3/22/16
EXHIBIT A
[Applicant’s Writings]
NONE
EXHIBIT B
INSURANCE REQUIREMENTS FOR NON-PROFIT AND FOR PROFIT ENTITIES
(A) Applicant shall procure and maintain for the duration of the Agreement the following types of insurance, in amounts no less than the stated limits, against claims for injuries to persons or damages to property which may arise from or in connection with the performance of the work hereunder; provided however, that if this project is (i) financial assistance of less than $100,000, (ii) a planning grant, or (iii) a predevelopment loan, only items 1 and 2 as set forth herein shall apply:
1) Commercial General Liability : $1,000,000 combined single limit per occurrence for bodily injury, personal injury and property damage. Coverage shall include Premises and Operation, Independent Contractors, Product and Completed Operations and Contractual Liability. If a general aggregate is used, the general aggregate limit shall apply separately to the Agreement or the general aggregate limit shall be twice the occurrence limit.
2) Workers’ Compensation and Employer’s Liability : Statutory coverage in compliance with compensation laws of the State of Connecticut. Coverage shall include Employer’s Liability with a minimum limit of $100,000 each accident, and $500,000 Disease – Policy limit, $100,000 each employee.
3) Automobile Liability : $1,000,000 combined single limit per accident for bodily injury. Coverage extends to owned, hired and non-owned automobiles. If the vendor/contractor does not own an automobile, but one is used in the execution of the contract, then only hired and non-owned coverage is required. If a vehicle is not used in the execution of the contract then automobile coverage is not required.
4) Directors and Officers Liability : $1,000,000 per occurrence limit of liability; provided, however, that Directors and Officers Liability insurance shall not be required for limited liability corporations or limited partnerships.
5) Comprehensive Crime Insurance : $100,000 limit for each of the following coverages: Employee Dishonesty (Form O), Forgery/Alteration (Form B), and Money and Securities coverage for Theft, Burglary, Robbery, Disappearance and Destruction.
6) Builders Risk : (Construction Phase) With respect to any work involving the construction of real property during the construction project, if DECD is taking a collateral position in the property, the Applicant shall maintain Builder’s Risk insurance providing coverage for the entire work at the project site. Coverage shall be on a Completed Value form basis in an amount equal to the projected value of the project. Applicant agrees to endorse the State of Connecticut as a Loss Payee.
7) Property Insurance : (Post Construction) If DECD is taking a collateral position in the property, the Applicant shall maintain insurance covering all risks of direct physical loss, damage or destruction to real and personal property and improvements and betterments (including flood insurance if property is within a duly designated Flood Hazard Area as shown on Flood Insurance Rate Maps (FIRM) set forth by the Federal Emergency Management Agency (FEMA)) at 100% of Replacement Value for such real and personal property, improvements and betterments or the maximum amount available under the National Flood Insurance Program. The State of Connecticut shall be listed as a Loss Payee.
(B) Additional Insurance Provisions
1) The State of Connecticut Department of Economic and Community Development, its officials and employees shall be named as an Additional Insured on the Commercial General Liability policy. Additional Insured status is not required for items (A)2 through (A)7 above.
2) Described insurance shall be primary coverage and Applicant and Applicant’s insurer shall have no right of subrogation recovery or subrogation against the State of Connecticut.
3) Applicant shall assume any and all deductibles in the described insurance policies.
4) Without limiting Applicant’s obligation to procure and maintain insurance for the duration identified in (A) above, each insurance policy shall not be suspended, voided, cancelled or reduced except after thirty (30) days prior written notice by certified mail has been given to the State of Connecticut, with the exception that a ten (10) day prior written notice by certified mail for non-payment of premium is acceptable.
5) Each policy shall be issued by an Insurance Company licensed to do business by Connecticut Department of Insurance and having a Best Rating of A-, VII, or equivalent or as otherwise approved by DECD.
Exhibit C
NOTICE TO EXECUTIVE BRANCH STATE CONTRACTORS AND PROSPECTIVE STATE
CONTRACTORS OF CAMPAIGN CONTRIBUTION AND SOLICITATION BAN
This notice is provided under the authority of Connecticut General Statutes 9 ‑612(g)(2), as amended by P.A. 10-1, and is for the purpose of informing state contractors and prospective state contractors of the following law (italicized words are defined below):
Campaign Contribution and Solicitation Ban
N o s t a t e cont r a cto r , p r o s pect i ve s t a t e cont r a cto r , pr i n ci pa l of a s t a t e co nt rac t or or pr i n cipal of a p r o s pect i ve s t a t e cont r a cto r , with reg a rd to a state cont r a ct o r s t ate co ntract so l icit a t ion with or from a st a t e age n cy in the executive br a n ch or a quasi-public agency or a holder, or pr i n c i pal of a h o l d e r of a v a li d p re q ua lif ication c e rtificate, s h all m ake a contribu tio n t o ( i ) a n e xp l ora t o r y co mmitt ee or ca n d i da te c o mm i t t ee established by a cand i date f o r no m i n ation o r election to t h e o f fice of G o v er n o r , Lieut e n a nt G ov e r no r, A tt o rney Gen e r a l, State C o m p t r o lle r, Secretary of the State o r State Treasurer, (ii) a po litical c o mm i ttee a u t ho r ized to m a k e con t rib u ti on s o r e xp e n d it u res t o or for t h e b e n efit of such ca nd i d ates, or (iii) a p ar t y c o mmit t ee ( wh ich i n c l u d es t o wn c o mmit t ees).
In a dd itio n , no h o l d er or pri n ci p al o f a h o l d er of a v a l id p req u alificati o n certificate, s h all m a k e a c on tr i bu tion t o (i) an e x ploratory co mmitt ee or ca n d i date comm i tt ee es t ab li shed by a c and i date f o r no m i n at i on or elect i on t o t h e o f f i ce o f S t ate senat o r or S t ate represe n tati v e, (ii) a p o litical c o mmittee a uth orized t o m a k e co n t rib u ti o ns o r ex p en d itures to or for t h e b e n e fit of s u ch can d i d ates, o r (iii) a p ar t y c o mmi t t e e.
On and after Ja nu a ry 1, 2 011, no state c on t ract o r, pros p ec t i v e state co n tract o r, pri n ci p al o f a state c on t ract o r or p r i n ci p al o f a pro s p e ctive state contractor, with r e gard t o a state contra c t or state con t ract s o licitati o n with o r fr o m a state agency i n the e x ecut i ve br a n c h o r a qu a si-public agency or a holder, or pr i n c ip al of a ho l der of a va li d pr eq ua li f i cat i on ce rti f i cate, sha l l knowing l y s o licit contri b u tio n s from the state contr a ctor ' s or prospective s t ate contractor ' s e m ployees or from a sub co n trac t o r o r p ri n cip a ls o f t h e su b co n tr a ct o r on beha l f of ( i ) an expl o rat o ry co mm ittee or candidate comm i ttee established by a cand i date f o r nom i n ation or e l ection to t h e o f fice of G ov er n o r , Lie u te n a n t Go v ern o r, Attorney Ge n e ral, S t ate C o m p tr o ller, Sec r etary of t h e State o r State Treasurer, ( i i) a p o litical c o mm i ttee authorized to ma k e co n trib u t i on s or e xp e ndit u res to or for t h e b e n e fit of s u ch can d i d ates, or (iii) a p arty c o mmittee.
Duty to Inform
State contractors and prospective state contractors are required to inform their principals of the above prohibitions, as applicable, and the possible penalties and other consequences of any violation thereof.
Penalties for Violations
Contributions or solicitations of contributions made in violation of the above prohibitions may result in the following civil and criminal penalties:
Civil penalties ‑ ‑$2000 or twice the amount of the prohibited contribution, whichever is greater, against a principal or a contractor. Any state contractor or prospective state contractor which fails to make reasonable efforts to comply with the provisions requiring notice to its principals of these prohibitions and the possible consequences of their violations may also be subject to civil penalties of $2000 or twice the amount of the prohibited contributions made by their principals.
Criminal penalties ‑Any knowing and willful violation of the prohibition is a Class D felony, which may subject the violator to imprisonment of not more than 5 years, or $5000 in fines, or both.
Contract Consequences
In t h e case o f a s t ate c o n t ra ct or, c o n t r ib u tio ns m ade o r soli c it ed i n v i o lati on of t h e ab ove p r o h i b iti ons m ay resu l t i n t h e co ntract being vo i de d .
In the case of a prospective s t ate contract o r, con t r i b u ti on s m a d e o r so licited in v i o l ati o n of t h e a b o v e pr oh i bitions s h all re s u lt in t h e c on t ract d escr i b ed in t h e state co n t ract s o licitati o n n o t b e i n g awar d ed to t h e prospective state con t rac t or, un l ess the State Elections E n force m ent C o mm iss i on d eter m i n es t h at m itigating cir c u m stances exi s t conc er ni n g su ch violati o n.
T h e State s h all n o t award a n y o t h e r state co n tract to a n yone f o und in v i o l ati o n o f t h e ab ov e pr oh i b iti on s for a p e riod of on e year after the electi o n for w h ich s u ch co n t rib u ti o n is m ad e o r s o licite d , u n less t h e State Electi on s E n f o rce m e n t Commis s i o n d eter m i n es t h at m i ti g ati n g circu m stances exist concern i ng s u c h violation.
Ad d iti on al inf o r m ati o n m a y b e f o und on the we b site of the State Elections E n force m ent C o mmission, www.ct.gov/ s eec. Click o n t h e li n k to “ L o b b y ist/Con t ractor Li m itations.”
Definitions :
“State contractor” means a person, business entity or nonprofit organization that enters into a state contract. Such person, business entity or nonprofit organization shall be deemed to be a state contractor until December thirty ‑first of the year in which such contract terminates. “State contractor” does not include a municipality or any other political subdivision of the state, including any entities or associations duly created by the municipality or political subdivision exclusively amongst themselves to further any purpose authorized by statute or charter, or an employee in the executive or legislative branch of state government or a quasi- public agency, whether in the classified or unclassified service and full or part ‑time, and only in such person’s capacity as a state or quasi ‑public agency employee.
“Prospective state contractor” means a person, business entity or nonprofit organization that (i) submits a response to a state contract solicitation by the state, a state agency or a quasi ‑public agency, or a proposal in response to a request for proposals by the state, a state agency or a quasi ‑public agency, until the contract has been entered into, or (ii) holds a valid prequalification certificate issued by the Commissioner of Administrative Services under section 4a ‑100. “Prospective state contractor” does not include a municipality or any other political subdivision of the state, including any entities or associations duly created by the municipality or political subdivision exclusively amongst themselves to further any purpose authorized by statute or charter, or an employee in the executive or legislative branch of state government or a quasi ‑public agency, whether in the classified or unclassified service and full or part ‑time, and only in such person’s capacity as a state or quasi ‑public agency employee.
“Principal of a state contractor or prospective state contractor” means (i) any individual who is a member of the board of directors of, or has an ownership interest of five per cent or more in, a state contractor or prospective state contractor, which is a business entity, except for an individual who is a member of the board of directors of a nonprofit organization, (ii) an individual who is employed by a state contractor or prospective state contractor, which is a business entity, as president, treasurer or executive vice president, (iii) an individual who is the chief executive officer of a state contractor or prospective state contractor, which is not a business entity, or if a state contractor or prospective state contractor has no such officer, then the officer who duly possesses comparable powers and duties, (iv) an officer or an employee of any state contractor or prospective state contractor who has managerial or discretionary responsibilities with respect to a state contract, (v) the spouse or a dependent child who is eighteen years of age or older of an individual described in this subsection, or (vi) a political committee established or controlled by an individual described in this subsection or the business entity or nonprofit organization that is the state contractor or prospective state contractor.
“State contract” means an agreement or contract with the state or any state agency or any quasi ‑public agency, let through a procurement process or otherwise, having a value of fifty thousand dollars or more, or a combination or series of such agreements or contracts having a value of one hundred thousand dollars or more in a calendar year, for (i) the rendition of services, (ii) the furnishing of any goods, material, supplies, equipment or any items of any kind, (iii) the construction, alteration or repair of any public building or public work, (iv) the acquisition, sale or lease of any land or building, (v) a licensing arrangement, or (vi) a grant, loan or loan guarantee. “State contract” does not include any agreement or contract with the state, any state agency or any quasi ‑public agency that is exclusively federally funded, an education loan or a loan to an individual for other than commercial p urpo s es or a n y a gree m ent or cont r a c t b e tween the sta t e or an y sta t e agen c y and t h e Un i ted S ta t es Depa r t m ent of t h e Na v y or t he Uni t ed S t ates Depart m ent o f D e fense.
“State contract solicitation” means a request by a state agency or quasi ‑public agency, in whatever form issued, including, but not limited to, an invitation to bid, request for proposals, request for information or request for quotes, inviting bids, quotes or other types of submittals, through a competitive procurement process or another process authorized by law waiving competitive procurement.
“Managerial or discretionary responsibilities with respect to a state contract” means having direct, extensive and substantive responsibilities with respect to the negotiation of the state contract and not peripheral, clerical or ministerial responsibilities.
“Dependent child” means a child residing in an individual’s household who may legally be claimed as a dependent on the federal income tax of such individual.
“Solicit” means (A) requesting that a contribution be made, (B) participating in any fund ‑raising activities for a candidate committee, exploratory committee, political committee or party committee, including, but not limited to, forwarding tickets to potential contributors, receiving contributions for transmission to any such committee or bundling contributions, (C) serving as chairperson, treasurer or deputy treasurer of any such committee, or (D) establishing a political committee for the sole purpose of soliciting or receiving contributions for any committee. Solicit
does not include: (i) making a contribution that is otherwise permitted by Chapter 155 of the Connecticut General Statutes; (ii) informing any person of a position taken by a candidate for public office or a public official, (iii) notifying the person of any activities of, or contact information for, any candidate for public office; or (iv) serving as a member in any party committee or as an officer of such committee that is not otherwise prohibited in this section.
“Subcontractor” means a n y per s on, business entity or nonpro f it organization t h at contracts to perform part or all of the obligati o ns of a s tate co n tra c to r 's state cont r ac t . S uch person, bus i ness enti t y or n o nprofit or g ani z a t ion shall be d e em ed to be a su b contr a ctor u n til Dece m ber t hi r t y first of the y e ar in which the subco n tract terminates. “Subcontractor” does not inclu d e ( i) a municipality or a n y ot h e r p o litical subdi v ision of the state, i n clu d ing a n y e n ti t ies or associa t ions du l y created b y the m unicipal it y or polit i cal s ubdiv i sion exclusi v e l y a m ongst the m selves to furt h e r a n y purpose a u tho r ized b y s t at u te o r char t e r , or (ii) an empl o y ee in the exec u tive or le g islati v e branch of state government or a quasi-public agenc y , whether in the classified or unclassified s ervice a n d full or pa r t-time, and o n ly in such perso n ' s cap a city as a state or q uasi-public a g e n cy empl o y ee.
“Principal of a subcontractor” means (i) a n y individual who is a member of the b oard of di r ectors of, or has an ownership inte r est of five p er cent or more in, a subcont r acto r , which is a busi n ess entit y , exce p t for an indi v id u al who is a member of t h e board of directors of a nonprofit orga ni zation, ( ii) an i n dividual who is e m pl o y e d b y a subcont ra ctor, which is a business ent it y , as preside n t, t r e a surer or exec u ti v e v i ce preside nt , ( i ii) an indi v id u al who is t h e chief exec u tive officer of a subco n tractor, which is not a business ent i ty, or if a subco n t r actor h as no such officer, then t h e offi c er who duly possesses comparable powers and d u t i es, (iv) an off i cer or an e m pl o y e e of a n y sub c o n tractor who h as m anagerial or d i scretio n a r y r esponsibili t ies wi t h respe c t to a su b c ontr a ct with a state co nt racto r , (v) t h e spouse or a depe n dent c h ild who is eighteen y ears of age or ol d e r of an indi v idual described in this subparagrap h , o r (vi) a polit i cal co mm i t tee esta b lished o r contr o lled b y an individ u al de s cribed in this s u bparagraph or t h e business enti t y or nonpro fi t or g ani z ation t h at is the subcontractor.
PROMISSORY NOTE
$4,000,000.00 March _14 , 2016
Trumbull, Connecticut
FOR VALUE RECEIVED, the undersigned, VERMILLION, INC., a Delaware corporation authorized to conduct business in the State of Connecticut, with an office and principal place of business located at 12117 Bee Caves Road, Building III, Suite 100, Austin, Texas 78738 (the “Applicant”), promises to pay to the order of the STATE OF CONNECTICUT, acting by and through its DEPARTMENT OF ECONOMIC AND COMMUNITY DEVELOPMENT (“State”), at its office at 505 Hudson Street, Hartford, Connecticut 06106 or at such other place as the holder hereof (including State, hereinafter referred to as “Holder”) may designate, the sum of up to FOUR MILLION 00/100 DOLLARS ($ 4,000,000.00 ) or such lesser amount as may be due and payable to State under the terms and conditions of that certain Assistance Agreement of even date herewith by and between Applicant and State (the “Assistance Agreement”), the terms of which are incorporated by reference herein, together with interest on the unpaid balance of this Note at the rate set forth in Section 2(a) hereof, which interest shall be computed and payable as set forth therein, together with all taxes levied or assessed on this Note or the debt evidenced hereby against the Holder, and together with all reasonable costs, expenses and reasonable attorneys’ and other reasonable professionals’ fees incurred in any action to collect and/or enforce this Note or to enforce, protect, preserve, defend, realize upon or foreclose any security agreement, or other agreement securing or relating to this Note, including without limitation, all reasonable costs and expenses incurred to enforce, protect, preserve, defend or sustain the lien of said security agreement, or other agreement or in any litigation or controversy arising from or connected in any manner with said security agreement, or other agreement, or this Note. Applicant further agrees to pay all reasonable costs, expenses and reasonable attorneys’ and other reasonable professionals’ fees incurred by Holder in connection with any “workout” or default resolution negotiations involving legal counsel or other professionals and further in connection with any re-negotiation or restructuring of the indebtedness evidenced by this Note. Any such costs, expenses and/or fees remaining unpaid after demand therefor, may, at the discretion of the Holder, be added to the principal amount of the indebtedness evidenced by this Note.
All capitalized terms not otherwise defined herein shall have the meanings ascribed to such terms in the Assistance Agreement.
This Note has been executed and delivered subject to the following terms and conditions:
Lawful Interest . Notwithstanding any provisions of this Note, it is the understanding and agreement of the Applicant and Holder that the maximum rate of interest to be paid by Applicant to Holder shall not exceed the highest or the maximum rate of interest permissible to be charged under the laws of the State of Connecticut. Any amounts paid in excess of such rate shall be considered to have been payments in reduction of principal.
Payments of Principal and Interest .
(a) The principal amount of this Note shall bear interest at a rate of two percent (2%) per annum (the “Loan Interest Rate”) commencing on the date on which the initial advance in respect of the Loan is funded (the “Advancement Date”). Commencing on the first day of the second month following the Advancement Date, and continuing on the same day of each and every month thereafter until the date which is ten (10) years from the first day of the month following the Advancement Date (the “Maturity Date”), and so long as no Instance of Default shall have occurred and remains uncured past any applicable cure period, principal and interest under this Note shall be payable in one hundred twenty (120) equal monthly installments in such a manner as to fully amortize the Loan over the remaining term of this Note.
(b) The entire indebtedness under this Note, including, all outstanding principal (including amounts not forgiven or repaid), accrued and unpaid interest, if any, and any other obligations due hereunder or under the Assistance Agreement, shall be due and payable in full on the Maturity Date.
(c) Payments in respect of this Note shall be made payable to “The State of Connecticut, Department of Economic and Community Development”.
(d) The principal amount of this Note is subject to a Forgiveness Credit and a Job Penalty in accordance with the provisions of Section 2.17 of the Assistance Agreement.
(e ) In the event that a Job Penalty is assessed or a Forgiveness Credit is given in accordance with Section 2.17 of the Assistance Agreement, monthly payment of principal and interest shall be adjusted in accordance with said sections.
3. Late Charge . In the event Applicant fails to pay any installment of principal and/or interest within fifteen (15) days of the date when said amount was due and payable, without in any way affecting the Holder’s right to accelerate this Note, a late charge equal to five percent (5.00%) of such late payment shall, at the option of Holder, be assessed against Applicant and be due upon demand by the Holder.
4. Prepayments . The Applicant may prepay principal of this Note, in whole or in part, at any time without penalty or premium. Any and all prepayments shall be applied first to accrued and unpaid interest and then to unpaid principal in the inverse order of maturity, and shall not affect the obligation of Applicant to pay the regular installments required hereunder until the entire indebtedness has been paid except as otherwise provided in the Assistance Agreement.
5. Instances of Default . The Applicant agrees that the occurrence of an Instance of Default under the Assistance Agreement shall constitute an “Instance of Default” hereunder. Upon the occurrence of any Instance of Default, which remains uncured past any applicable cure period, if any, the entire indebtedness with accrued interest thereon and any other sums due under this Note, shall, at the option of the Holder, become immediately due and payable without presentment or demand for payment, notice of non-payment, protest or any other notice or demand of any kind, all of which are expressly waived by the Applicant. Failure to exercise such option shall not constitute a waiver of the right to exercise the same in the event of any subsequent default. Upon the occurrence of any Instance of Default the interest rate shall increase to fifteen per cent per annum
(15%) (the“Default Rate”) and liquidated damages may be assessed in accordance with Section 4.2(C)(3) of the Assistance Agreement.
6. No Waiver . No delay or omission by Holder in exercising any rights hereunder, nor failure by the Holder to insist upon the strict performance by Applicant of any terms and provisions herein shall operate as or be deemed to be a waiver of such right, any other right hereunder, or any terms and provisions herein, and the Holder shall retain the right thereafter to insist upon strict performance by the Applicant of any and all terms and provisions of this Note or any document securing the repayment of this Note. No waiver of any right shall be effective unless in writing and signed by Holder, nor shall a waiver on one occasion be considered as a bar to, or waiver of, any such right on any future occasion.
7. Prejudgment Remedy and Other Waivers . APPLICANT ACKNOWLEDGES THAT THE LOAN EVIDENCED BY THIS NOTE IS A COMMERCIAL TRANSACTION AND WAIVES APPLICANT’S RIGHTS TO NOTICE AND HEARING, OR THE ESTABLISHMENT OF A BOND, WITH OR WITHOUT SURETY, UNDER CHAPTER 903a OF THE CONNECTICUT GENERAL STATUTES, OR AS OTHERWISE ALLOWED BY ANY STATE OR FEDERAL LAW WITH RESPECT TO ANY PREJUDGMENT REMEDY WHICH HOLDER MAY DESIRE TO USE, AND FURTHER WAIVES DILIGENCE, DEMAND, PRESENTMENT FOR PAYMENT, NOTICE OF NONPAYMENT, PROTEST AND NOTICE OF PROTEST, AND NOTICE OF ANY RENEWALS OR EXTENSIONS OF THIS NOTE, AND ALL RIGHTS UNDER ANY STATUTE OF LIMITATIONS. THE APPLICANT ACKNOWLEDGES THAT APPLICANT MAKES THESE WAIVERS KNOWINGLY AND VOLUNTARILY, WITHOUT DURESS AND ONLY AFTER EXTENSIVE CONSIDERATION OF THE RAMIFICATIONS OF THIS WAIVER. THE APPLICANT FURTHER ACKNOWLEDGES THAT THE LENDER HAS NOT AGREED WITH OR REPRESENTED TO APPLICANT OR ANY OTHER PARTY HERETO THAT THE PROVISIONS OF THIS PARAGRAPH WILL NOT BE FULLY ENFORCED IN ALL INSTANCES.
8. Jury Waiver . THE APPLICANT HEREBY WAIVES TRIAL BY JURY IN ANY COURT AND IN ANY SUIT, ACTION OR PROCEEDING ON ANY MATTER ARISING IN CONNECTION WITH OR IN ANY WAY RELATED TO THE FINANCING TRANSACTIONS OF WHICH THIS NOTE IS A PART AND/OR THE ENFORCEMENT OF ANY OF YOUR RIGHTS AND REMEDIES, INCLUDING WITHOUT LIMITATION, TORT CLAIMS. THE APPLICANT ACKNOWLEDGES THAT APPLICANT MAKES THIS WAIVER KNOWINGLY AND VOLUNTARILY, WITHOUT DURESS AND ONLY AFTER EXTENSIVE CONSIDERATION OF THE RAMIFICATIONS OF THIS WAIVER. THE APPLICANT FURTHER ACKNOWLEDGES THAT THE LENDER HAS NOT AGREED WITH OR REPRESENTED TO APPLICANT OR ANY OTHER PARTY HERETO THAT THE PROVISIONS OF THIS PARAGRAPH WILL NOT BE FULLY ENFORCED IN ALL INSTANCES.
9. Miscellaneous . The provisions of this Note shall be binding upon the Applicant, its successors and assigns and shall inure to the benefit of Holder, its successors and assigns. If any provision of this Note shall, to any extent, be held invalid or unenforceable, then only such provision shall be deemed ineffective and the remainder of this Note shall not be affected. This Note shall be governed by and construed in accordance with the laws of the State of Connecticut (but not its conflicts of law provisions).
10. Security. This Note is secured by a Security Agreement and Patent Security Agreement between Applicant and the State dated as of even date herewith.
VERMILLION, INC.
By: /s/ Valeri e B. Palmieri ______ _ __
Valerie B. Palmieri
Its President and CEO
Duly Authorized
Dated: 3/14/16 _____________________
PATENT SECURITY AGREEMENT
This PATENT SECURITY AGREEMENT , dated as of March _14 , 2016, by VERMILLION, INC. (the “Grantor”), in favor of STATE OF CONNECTICUT , acting by and through its DEPARTMENT OF ECONOMIC AND COMMUNITY DEVELOPMENT , (the “Secured Party”).
W I T N E S S E T H :
WHEREAS, the Secured Party has agreed to extend to Grantor certain financial assistance in the form of a loan in an amount not to exceed FOUR MILLION AND NO/100 DOLLARS ($4,000,000.00), the terms of which are contained in that certain Assistance Agreement, Security Agreement, and other loan documents, dated of even date hereof (collectively the “Loan Documents”); and
WHEREAS, pursuant to those Loan Documents, the Grantor is required to execute and deliver this Patent Security Agreement;
NOW, THEREFORE, in consideration of the foregoing and to induce the Lender, for the benefit of the Secured Party, to enter into the Assistance Agreement, the Grantor hereby agrees with the Secured Party as follows:
SECTION 1. Defined Terms . Unless otherwise defined herein, defined terms used herein shall have the meaning given to them in the Loan Documents.
SECTION 2. Grant of Security Interest in Patent Collateral . The Grantor hereby pledges and grants to the Secured Party a lien on and security interest in and to all of its right, title and interest in, to and under all the following collateral of the Grantor:
(a) All the patents of the Grantor as listed on Schedule A attached hereto (collectively the “Patents”).
SECTION 3. The Security Agreement . The security interest granted pursuant to this Patent Security Agreement is granted in conjunction with the security interest granted to the Secured Party pursuant to the Security Agreement and the Grantor hereby acknowledges and affirms that the rights and remedies of the Secured Party with respect to the security interest in the Patents made and granted hereby are more fully set forth in the Security Agreement. In the event that any provision of this Patent Security Agreement is deemed to conflict with the Security Agreement, the provisions of the Security Agreement shall control unless the Secured Party shall otherwise determine.
Notwithstanding any requirements of the Security Agreement to the contrary, Grantor shall have the right to discontinue certain Patents by not filing the required patent maintenance fees, or otherwise discontinue, with the USPTO in the ordinary course of Grantor’s business, if Grantor has reasonably deemed those certain Patents to be obsolete. Grantor shall give Secured Party written notice of their intent not to maintain a given Patent within thirty (30) days of the
given patent maintenance fee due date with an explanation of why said Patent has become obsolete.
SECTION 4. Termination . Upon the termination of the Security Agreement in accordance thereof, the Secured Party shall, at the expense of the Grantor, execute, acknowledge, and deliver to the Grantor an instrument in writing in recordable form releasing the lien on and security interest in the Patents under this Patent Security Agreement and any other documents required to evidence the termination of the Secured Party’s interest in the Patents.
SECTION 5. Counterparts . This Patent Security Agreement may be executed in any number of counterparts, all of which shall constitute one and the same instrument, and any party hereto may execute this Patent Security Agreement by signing and delivering one or more counterparts.
GRANTOR
VERMILLION, INC.
BY _/s/ Valerie B. Palmieri ________
Valerie B. Palmieri
President and CEO, Duly Authorized
Dated: 3/14/16_________________
STATE OF CONNECTICUT
DEPARTMENT OF ECONOMIC
AND COMMUNITY DEVELOPMENT
By: /s/ Catherine H. Smith __ __ _
Name: Catherine H. Smith
Title: Commissioner
Duly Authorized
Dated: 3/22/16 _________________
Schedule A
Patents
European Patent Office |
Published |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
12749936.6 |
Feb 14,
|
|
2 |
Correlogic |
European Patent Office |
Published |
PROGNOSTIC BIOMARKERS IN PATIENTS WITH OVARIAN CANCER |
11835211.1 |
Oct 21,
|
|
1 |
OVA1 |
France |
Issued |
BIOMARKERS FOR OVARIAN CANCER |
06773938.3 |
Jun 23,
|
8465929 |
3 |
ApoC1 |
France |
Issued |
BIOMARKERS FOR THE DETECTION OF EARLY STAGE OVARIAN CANCER |
08843957.5 |
Oct 29,
|
7395160 |
3 |
CTAP3, ApoA1, CA125, Transthyretin |
Germany |
Issued |
BIOMARKERS FOR OVARIAN CANCER |
06773938.3 |
Jun 23,
|
8206934 |
3 |
ApoC1 |
Germany |
Issued |
BIOMARKERS FOR THE DETECTION OF EARLY STAGE OVARIAN CANCER |
08843957.5 |
Oct 29,
|
1262202 |
3 |
CTAP3, ApoA1, CA125, Transthyretin |
Germany |
Pending |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
1120120009908 |
Feb 14,
|
|
2 |
Correlogic |
Hong Kong |
Pending |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
14108246.9 |
Aug 12,
|
|
2 |
Correlogic |
India |
Pending |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
7669/CHENP/2013 |
Feb 14,
|
|
2 |
Correlogic |
India |
Pending |
PROGNOSTIC BIOMARKERS IN PATIENTS WITH OVARIAN CANCER |
3989/CHENP/2013 |
Oct 21,
|
|
1 |
OVA1 |
India |
Published |
PREDICTIVE MARKERS FOR OVARIAN CANCER |
00556/DELNP/2010 |
Jan 25,
|
|
2 |
Correlogic |
India |
Published |
PROCESS FOR DISCRIMINATING BETWEEN BIOLOGICAL STATES BASED ON HIDDEN PATTERNS FROM BIOLOGICAL DATA |
3847/KOLNP/2009 |
Nov 5,
|
|
4 |
Non-ovarian |
Japan |
Issued |
PROCESS FOR DISCRIMINATING BETWEEN BIOLOGICAL STATES BASED ON HIDDEN PATTERNS FROM BIOLOGICAL DATA |
2002-512687 |
Jul 18,
|
6925389 |
4 |
Non-ovarian |
Japan |
Pending |
BIOMARKERS FOR OVARIAN CANCER |
2014-247178 |
Jun 23,
|
|
1 |
OVA1 |
Japan |
Pending |
PROGNOSTIC BIOMARKERS IN PATIENTS WITH OVARIAN CANCER |
2013-535113 |
Oct 21,
|
|
1 |
OVA1 |
Japan |
Abandoned |
BIOMARKERS FOR OVARIAN CANCER |
2008-518478 |
Jun 23,
|
|
3 |
Calgranulin C, Transthyretin |
New Zealand |
Pending |
PROGNOSTIC BIOMARKERS IN PATIENTS WITH OVARIAN CANCER |
707493 |
Oct 21,
|
|
1 |
OVA1 |
Republic of Korea |
Published |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
10-2013-7025094 |
Feb 14,
|
|
2 |
Correlogic |
United Kingdom |
Issued |
BIOMARKERS FOR OVARIAN CANCER |
06773938.3 |
Jun 23,
|
2220506 |
3 |
ApoC1 |
United Kingdom |
Issued |
BIOMARKERS FOR THE DETECTION OF EARLY STAGE OVARIAN CANCER |
08843957.5 |
Oct 29,
|
8664358 |
3 |
CTAP3, ApoA1, CA125, Transthyretin |
United Kingdom |
Pending |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
13162227 |
Feb 14,
|
|
2 |
Correlogic |
United States of America |
Issued |
BIOMARKERS FOR OVARIAN CANCER |
12/079,592 |
Mar 27,
|
8221984 |
3 |
sMAP |
United States of America |
Issued |
BIOMARKERS FOR OVARIAN CANCER |
11/922,652 |
Dec 15,
|
2220506 |
3 |
Calcyclin;
|
United States of America |
Issued |
HEURISTIC METHOD OF CLASSIFICATION |
09/883,196 |
Jun 19,
|
7761239 |
4 |
Non-ovarian |
United States of America |
Issued |
HEURISTIC METHOD OF CLASSIFICATION |
11/735,028 |
Apr 13,
|
5246984 |
4 |
Non-ovarian |
United States of America |
Issued |
METHOD OF DIAGNOSING BIOLOGICAL STATES THROUGH THE USE OF A CENTRALIZED, ADAPTIVE MODEL, AND REMOTE SAMPLE PROCESSING |
11/008,784 |
Dec 10,
|
7096206 |
4 |
Non-ovarian |
United States of America |
Issued |
METHODS FOR DIAGNOSING OVARIAN CANCER |
12/584,832 |
Sep 11,
|
7499891 |
3 |
Protein C inhibitor |
United States of America |
Issued |
PREDICTIVE MARKERS FOR OVARIAN CANCER |
12/165,240 |
Jun 30,
|
8664358 |
2 |
ApoA1, CA125, + non OVA1/2 marker |
United States of America |
Issued |
PROCESS FOR DISCRIMINATING BETWEEN BIOLOGICAL STATES BASED ON HIDDEN PATTERNS FROM BIOLOGICAL DATA |
09/906,661 |
Jul 18,
|
6925389 |
4 |
Non-ovarian |
United States of America |
Issued |
QUALITY ASSURANCE/QUALITY CONTROL FOR ELECTROSPRAY IONIZATION PROCESSES |
10/628,136 |
Jul 28,
|
7395160 |
4 |
Non-ovarian |
United States of America |
Issued |
PREDICTIVE MARKERS FOR OVARIAN CANCER |
14/172,237 |
Feb 4,
|
92741118 |
2 |
Correlogic |
United States of America |
Pending |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
14/099,522 |
Dec 6,
|
|
2 |
Correlogic |
United States of America |
Pending |
BIOMARKERS FOR BREAST CANCER |
11/917,766 |
Dec 28,
|
|
4 |
Non-ovarian (Breast) |
United States of America |
Pending |
BIOMARKERS FOR OVARIAN CANCER |
13/916,421 |
Jun 12,
|
|
2 |
HE4, B2M, CA125, Transferrin, Transthyretin |
United States of America |
Pending |
BIOMARKERS FOR THE DETECTION OF EARLY STAGE OVARIAN CANCER |
13/909,022 |
Jun 3,
|
|
3 |
CTAP3, ApoA1, CA125, Transferrin, Transthyretin |
United States of America |
Pending |
PREDICTIVE MARKERS AND BIOMARKER PANELS FOR OVARIAN CANCER |
14/465,682 |
Aug 21,
|
|
2 |
Correlogic |
United States of America |
Pending |
PROGNOSTIC BIOMARKERS IN PATIENTS WITH OVARIAN CANCER |
14/073,668 |
Nov 6,
|
|
1 |
OVA1 |
United States of America |
Published |
OVARIAN CANCER BIOMARKERS |
11/922,621 |
Apr 13,
|
|
1 |
OVA1 |
United States of America |
Published |
PROGNOSTIC BIOMARKERS IN PATIENTS WITH OVARIAN CANCER |
12/422,530 |
Apr 13,
|
|
1 |
OVA1 |
SECURITY AGREEMENT
This SECURITY AGREEMENT (the "Agreement") is made and entered into this 14 th day of March, 2016 by and between the STATE OF CONNECTICUT acting by and through its DEPARTMENT OF ECONOMIC AND COMMUNITY DEVELOPMENT , having an office and principal place of business located at 505 Hudson Street, Hartford, Connecticut 06106 (the " Secured Party ") and VERMILLION INC, a Delaware corporation with an office and principal place of business located at 12117 Bee Caves Road, Building III, Suite 100, Austin, TX 78738 (the " Debtor ").
WITNESSETH:
WHEREAS, the Secured Party has agreed to extend to Debtor certain Financial Assistance under the Economic Development and Manufacturing Assistance Act in the form of a loan in an amount not to exceed FOUR MILLION AND NO/100 DOLLARS ($4,000,000.00 ) (the “Loan” or the "Financial Assistance"); and
WHEREAS, the terms and conditions of the Financial Assistance are set forth in a certain Assistance Agreement of even date herewith by and between Secured Party and Debtor (the "Assistance Agreement"); and
WHEREAS, as a condition precedent to the extension of the Financial Assistance, Secured Party requires Debtor to provide a security interest in certain of its personal property as security for the payment and performance of Debtor's obligations under the Assistance Agreement;
NOW, THEREFORE, in consideration of the foregoing and of the covenants set forth herein, the Secured Party and the Debtor hereby agree as follows:
ARTICLE I
COLLATERAL
Section 1.1. Grant of Security Interest . As security for the payment and performance of the Obligations (as hereinafter defined), the Debtor hereby grants to the Secured Party a continuing security interest in the property of the Debtor listed and described in Schedule A attached hereto (the "Collateral").
Section 1.2. Definitions . All capitalized terms not otherwise defined herein, including Schedule A attached hereto, shall have the meanings ascribed to such terms in Article 9 of the Uniform Commercial Code as from time to time in effect in the State of Connecticut (“UCC”).
ARTICLE II
OBLIGATIONS SECURED
Section 2.1. Obligations Secured . The Collateral and the power of collection pertaining thereto shall secure the payment and performance of any and all obligations of the Debtor to the Secured Party under the Assistance Agreement, including, without limitation, the Debtor's obligation to repay the Financial Assistance, plus accrued and unpaid interest thereon, together with all commercially reasonably fees, expenses, commissions, charges, penalties, and other amounts paid or incurred by the Secured Party in connection therewith, (collectively, the "Obligations").
ARTICLE III
DUTIES OF THE DEBTOR REGARDING COLLATERAL
Section 3.1. Duties of the Debtor Regarding Collateral . At all times hereafter the Debtor agrees that it shall:
(a) Preserve the Collateral in good condition and order and not permit it to be abused or misused;
(b) Maintain good and complete title to the Collateral;
(c) Keep the Collateral free and clear at all times of all other security interests, liens, or encumbrances of any kind, including, without limitation, any lien arising as a result of the Debtor's failure to pay any and all taxes or governmental assessments or charges of any kind whatsoever except as otherwise permitted by the Secured Party;
(d) Except as otherwise expressly provided herein, refrain from selling, assigning or otherwise disposing of any of the Collateral (except in the ordinary course of Debtor's business) or moving or removing any of the Collateral without the prior written consent of the Secured Party, or until all of the Obligations have been paid or performed in full;
(e) Promptly provide to the Secured Party such financial statements, reports, lists and schedules related to the Collateral and any other information relating to the Collateral as the Secured Party from time to time may reasonably request;
(f) Permit the Secured Party to inspect all books and records of the Debtor relating to the Collateral at such times, upon such notice and as often as the Secured Party may reasonably request;
(g) Notify the Secured Party of any material change in any fact or circumstance warranted or represented by the Debtor herein or furnished in connection herewith to the Secured Party or if any Event of Default (as defined herein) occurs;
(h) Keep the Collateral insured against fire and other risks; and
(i) Deliver a certificate of insurance for the Collateral to the Secured Party upon the request of the Secured Party.
(j) Do whatever the Secured Party may request from time to time by way of obtaining, executing, delivering and filing financing statements, assignments, landlord's or mortgagee's waivers, and other notices and amendments and renewals thereof, and the Debtor will take any and all steps and observe such formalities as the Secured Party may request in order to create and maintain a valid and enforceable first lien upon, pledge of, and first priority security interest in, any and all of the Collateral, except as permitted by the Assistance Agreement. The Secured Party is authorized to file financing statements without the signature of the Debtor and to execute and file such financing statements on behalf of the Debtor as specified by the UCC to perfect or maintain the Secured Party's security interest in all of the Collateral. All commercially reasonable charges, expenses and fees the Secured Party may incur in filing any of the foregoing, together with reasonable costs and expenses of any lien search required by the Secured Party, and any taxes relating thereto, shall be charged to the Debtor and added to the Obligations.
(k) Execute that certain Patent Security Agreement with respect to all the patents of the Debtor, a copy of which will be filed with the U.S. Patent and Trademark Office.
Section 3.2. Negative Covenants of the Debtor . The Debtor covenants and agrees that at all times hereafter the Debtor shall not:
(a) Merge into or consolidate with or into any corporation or other entity, convert into any other entity or transfer to or domesticate in any jurisdiction other than the jurisdiction set forth in Section 6.1 (a) of this Agreement;
(b) Sell, lease, license or otherwise dispose of any of its assets, except for sales of inventory in the ordinary course of business;
(c) Change its corporate name, identity or structure, or conduct its business under any trade name or style other than as set forth in this Agreement;
(d) Permit to incur or suffer any loss, theft, substantial damage or destruction of any of the Collateral which is not immediately replaced with Collateral of equal or greater value, or which is not fully covered by insurance, the proceeds of which shall have been endorsed over to Secured Party;
(e) Fail to preserve and maintain its entity existence in the jurisdiction of its incorporation, organization or formation; or
(f) File any UCC-3 termination statement affecting any UCC-1 Financing Statement in favor of the Secured Party.
ARTICLE IV
DEFAULT
Section 4.1. Defined . The occurrence of any of the following events shall constitute a default under this Agreement (an "Event of Default"):
(a) The failure of the Debtor to perform or comply with any act, duty, covenant or obligation required to be performed under this Agreement;
(b) The failure of the Debtor to make payments as required pursuant to the Assistance Agreement or the default by the Debtor of its obligations under the Assistance Agreement.
(c) If any of the representations or warranties of the Debtor set forth in Section 6.1.of this Agreement shall prove to be incorrect in any material respect;
(d) If any material portion of the Collateral shall be damaged, destroyed or otherwise lost and such damage, destruction or loss is not covered by insurance.
ARTICLE V
REMEDIES
Section 5.1. Rights and Remedies Upon Default . If an Event of Default shall have occurred hereunder or under the Assistance Agreement, the Secured Party may, at its sole option, without notice or demand, declare the Obligations to be immediately due and payable. As to any Collateral, the Secured Party shall have the rights and remedies of any secured creditor under the UCC or under any other applicable law as in effect, from time to time, in Connecticut including, without limitation, the right to take possession of the Collateral, and in addition thereto, the right to enter upon any premises on which the Collateral or any part thereof may be situated and remove the same therefrom and the right to occupy the Debtor’s premises for the purposes of liquidating Collateral, including without limitation, conducting an auction thereon. The Secured Party may require the Debtor to make the Collateral (to the extent the same is moveable) available to the Secured Party at a place to be designated by the Secured Party. The Secured Party may, at its option, sell the Collateral on credit, and furthermore may sell the Collateral without giving any warranties as to the Collateral and may specifically disclaim any warranties of title or the like, which shall not be considered to adversely affect the commercial reasonableness of any sale of the Collateral. Unless the Collateral is perishable or threatens to decline speedily in value or is of a type customarily sold on a recognized market, the Secured Party will give the Debtor at least five (5) days' prior written notice at the address of the Debtor set forth in Section 8.10 hereof (or at such other address or addresses as the Debtor shall specify in writing to the Secured Party) of the time and place of any public sale thereof or of the time after which any private sale or any other intended disposition thereof is to be made. Any such notice shall be deemed to meet any requirement hereunder or under any applicable law (including the UCC) that reasonable notification be given of the time and place of such sale or other disposition. After deducting all commercially reasonable costs and expenses of collection, storage, custody, sale or other disposition and delivery (including reasonable attorneys' fees) and
all other reasonable charges against the Collateral, the residue of the Proceeds of any such sale or disposition shall be applied to the payment of the Obligations in such order of priority as Secured Party shall determine and any surplus shall be returned to the Debtor or to any person or party lawfully entitled thereto. In the event the Proceeds of any sale, lease or other disposition of the Collateral hereunder, including without limitation, the Proceeds from the collection of Accounts, are insufficient to pay all of the Obligations in full, the Debtor will be liable for the deficiency, together with interest thereon, as set forth in the Assistance Agreement, and at the reasonable costs and expenses of collection of such deficiency, including (to the extent permitted by law) without limitation, attorneys' fees, expenses and disbursements.
Section 5.2 Right of Secured Party to Use and Operate Collateral, Etc . Upon the occurrence of any Event of Default, Secured Party shall have the right and power to take possession of all or any part of the Collateral, and to exclude the Debtor and all persons claiming under the Debtor wholly or partly therefrom, and thereafter to hold, store, and/or use, operate, manage and control the same. Upon any such taking of possession, the Secured Party without obligation to do so, may, from time to time, at the expense of the Debtor, make all such repairs, replacements, alterations, additions and improvements to the Collateral as the Secured Party may deem proper. The Debtor hereby expressly waives any obligation of the Secured Party to process and/or prepare any Collateral prior to any sale or other disposition thereof. Upon any taking of possession of all or any part of the Collateral, the Secured Party shall have the right to manage and control the Collateral and to carry on the business and to exercise all rights and powers of the Debtor in respect thereto as Secured Party shall reasonably deem best, including the right to enter into any and all such agreements with respect to the operation of the Collateral or any part thereof as Secured Party may see fit; and Secured Party shall be entitled to collect and receive all issues, profits, fees, revenues and other income of the same and every part thereof. Such issues, profits, fees, revenues and other income shall be applied to pay the expenses of holding and operating the Collateral and of conducting the business thereof, and of all maintenance, repairs, replacements, alterations, additions and improvements, and to make all payments which Secured Party may be required or may elect to make, if any, for taxes, assessments, insurance and other charges upon the Collat eral or any part thereof, and all other payments which Secured Party may be required or authorized to make under any provision of this Agreement (including legal costs and attorneys' fees). The remainder of such issues, profits, fees, revenues and other income shall be applied to the payment of the Obligations in such order of priority as the Secured Party shall reasonably determine. Without limiting the generality of the foregoing, the Secured Party shall have the right to apply for and have a receiver appointed by a court of competent jurisdiction in any action taken by Secured Party to enforce its rights and remedies hereunder in order to manage, protect and preserve the Collateral and continue the operation of the business of the Debtor and to collect all revenues and profits thereof and apply the same to the payment of all expenses and other charges of such receivership including the compensation of the receiver and to the payment of the Obligations as aforesaid until a sale or other disposition of such Collateral shall be finally made and consummated.
Section 5.3 Collection of Accounts Receivable, Etc . At any time after default, the Secured Party shall have the right to require the Debtor to and the Debtor shall, upon written notice from the Secured Party:
(a) Make collections of Proceeds upon its Accounts, hold the Proceeds received from collections in trust for the Secured Party and turn over such Proceeds to the Secured Party daily in the exact form in which they are received, together with a collection report in form satisfactory to the Secured Party. The Secured Party shall immediately apply, subject to collection, such Proceeds and any Proceeds of Accounts received by it pursuant to the following provisions of this Section 5.3, to the payment of the Obligations in such order of priority as the Secured Party shall determine;
(b) Assign or endorse the Accounts to the Secured Party, and notify account debtors that the Accounts have been assigned and should be paid directly to the Secured Party;
(c) Turn over to the Secured Party all Inventory returned in connection with any of the Accounts;
(d) Mark or stamp each of its individual ledger sheets or cards pertaining to its Accounts with the legend “Assigned to the State of Connecticut Department of Economic and Community Development,” and stamp or otherwise mark and keep its books, records, documents and instruments relating to the Accounts in such manner as the Secured Party may require; and
(e) Mark or stamp all invoices with a legend satisfactory to the Secured Party so as to indicate that the same should be paid directly to the Secured Party.
Notwithstanding the foregoing, the Secured Party shall have the right, at any time after the occurrence of an Event of Default, to itself so notify such account debtors to make such payments of the Accounts directly to the Secured Party and the Secured Party shall have the further right to notify the post office authorities to change the address for delivery of mail of the Debtor to an address designated by the Secured Party and to receive, open and dispose of all mail addressed to Debtor. For the purposes of this Section 5.3, the Debtor hereby irrevocably constitutes the Secured Party as the Debtor 's attorney-in-fact to issue in the name and execute or endorse on behalf of Debtor each and every notice, instrument and document necessary to carry out the purposes of the provisions of this Section 5.3, and to take such action in connection with the collection of the Accounts, including without limitation, suing thereon, compromising or adjusting the same, as Secured party, in its sole discretion, deems necessary. The power of attorney granted hereby shall be self-executing, but Debtor shall promptly execute and deliver to Secured Party, upon written request of Secured Party, such additional separate powers of attorney as Secured Party may from time to time request.
ARTICLE VI
WARRANTIES
Section 6.1. Warranties . The Debtor represents and warrants:
(a) That the Debtor is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware (“Debtor’s State”) and has all requisite power and authority to own and operate its properties and to carry on its business as now being conducted. The Debtor is not organized under the laws of any jurisdiction other than the Debtor’s State. The Debtor is authorized to conduct business in the State of Connecticut.
(b) That the Debtor is the owner of and has good and marketable title to the Collateral secured hereby;
(c) That the Debtor has not granted, nor will the Debtor grant a security interest in the Collateral to any other individual or entity and that such Collateral is free and clear of any mortgage, pledge, lease, trust, bailment, lien, security interest, encumbrance, charge or other arrangement except as shown on Schedule B attached hereto;
(d) That the Debtor has the authority and capacity to perform its obligations hereunder; and
(e) That the Debtor's true and correct name, any tradename(s) under which the Debtor conducts its business, its chief executive office, its place(s) of business, and the location(s) of the Collateral or records relating to the collateral are set forth on Schedule C attached hereto and incorporated herein by this reference.
ARTICLE VII
WAIVERS
Section 7.1. Waivers . The Debtor waives any right to require the Secured Party to (a) proceed against any person, including the Debtor or any guarantor; (b) proceed against any other collateral under any other agreement; and (c) pursue any other remedy in the Secured Party's power.
ARTICLE VIII
MISCELLANEOUS
Section 8.1. Attorney ‑in ‑Fact . The Debtor appoints the Secured Party as its true attorney ‑in ‑fact to perform any of the following powers, which shall be irrevocable until termination of this Agreement and may be exercised, from time to time, by the Secured Party's officers and employees or any of them in the event of a default hereunder or under the Assistance Agreement: (i) to perform any obligation of the Debtor hereunder in the Debtor's name or otherwise; (ii) to liquidate any time deposit held hereunder as Collateral prior to the maturity date of such time deposit(s) and to apply proceeds thereof to payment of the Obligations, notwithstanding the fact that such liquidation may give rise to Federal penalties for early withdrawal of funds from a time deposit; (iii) to collect by legal proceedings or otherwise all dividends, interest, principal or other sums now or hereafter payable upon or on account of the Collateral, to accept other property in exchange for the Collateral, and to do and perform such acts and things as the Secured Party may deem proper, and any money or property received in exchange for the Collateral may be applied to the Obligations to the Secured Party or held by the
Secured Party under this Agreement; (v) to make any compromise or settlement which the Secured Party deems desirable or proper in respect of the Collateral; and (vi) to insure, process and preserve the Collateral.
Section 8.2 Perfection by Filing . The Secured Party may at any time and from time to time, at Debtor’s expense, file financing statements, continuation statements and amendments thereto that describe the Collateral as all assets of the Debtor or words of similar effect and which contain any other information required by the UCC for the sufficiency or filing office acceptance of any financing statement, continuation statement or amendment, including whether the Debtor is an organization, the type of organization and any tax and/or organization identification number issued to the Debtor. The Debtor agrees to furnish any such information to the Secured Party promptly upon reasonable request. Any such financing statements, continuation statements or amendments may be signed, if so required, by the Secured Party on behalf of the Debtor, and may be filed at any time in any jurisdiction as necessary. The Debtor hereby irrevocably appoints the Secured Party, through any of its chosen agents or designees, as Debtor’s attorney-in-fact, coupled with an interest, for the purposes hereof.
Section 8.3 Other Perfection, etc . The Debtor shall at any time and from time to time, at Debtor ’s expense, take such steps as the Secured Party may reasonably request for the Secured Party (a) to obtain an acknowledgement, in form and substance satisfactory to the Secured Party, of any bailee having possession of any of the Collateral that the bailee holds such Collateral for the Secured Party, (b) to obtain “control” of any Investment Property, Deposit Accounts, Letter-Of-Credit Rights or electronic Chattel Paper (as such terms are defined in the UCC), with any agreements establishing control to be in form and substance satisfactory to the Secured Party, (c) to obtain possession of all or any portion of the Collateral in order to perfect its security interest therein in addition to the filing of a financing statement, and (d) otherwise to insure the continued perfection and priority of the Secured Party’s security interest in any of the Collateral and of the preservation of its rights therein.
Section 8.4. Application of Payments . To the extent that the Debtor uses the proceeds of the Financial Assistance secured hereby to purchase any Collateral, the Debtor’s repayment shall be applied on a “first-in-first-out” basis so that the portion of said Financial Assistance used to purchase a particular item of Collateral shall be paid in the chronological order Debtor purchased such Collateral.
Section 8.5. Expenses . The Debtor shall be liable to pay, five (5) days following demand, all costs and expenses, including reasonable attorneys' fees and expenses, incurred by the Secured Party in administering, enforcing, collecting or realizing upon any of the Obligations of the Collateral or in taking any action necessary to preserve and protect the Secured Party's security interest in the Collateral, and all expenses in connection with the establishment of this Agreement.
Section 8.6. Commercial Transaction . DEBTOR ACKNOWLEDGES THAT THE TRANSACTION OF WHICH THIS AGREEMENT IS A PART IS A COMMERCIAL TRANSACTION AND WAIVES ITS RIGHTS TO NOTICE AND HEARING UNDER CHAPTER 903(A) OF THE CONNECTICUT GENERAL STATUTES OR AS MAY OTHERWISE BE REQUIRED BY ANY LAW WITH RESPECT TO ANY PREJUDGMENT REMEDY WHICH THE SECURED PARTY MAY SEEK OR BE PERMITTED TO USE.
Section 8.7 Waiver of Jury Trial . DEBTOR HEREBY WAIVES TRIAL BY JURY IN ANY COURT IN ANY SUIT, ACTION OR PROCEEDING OR ANY MATTER ARISING IN CONNECTION WITH OR IN ANY WAY RELATED TO THE TRANSACTION OF WHICH THIS AGREEMENT IS A PART AND/OR THE ENFORCEMENT OF ANY OF ITS RIGHTS AND REMEDIES. DEBTOR ACKNOWLEDGES THAT IT MAKES THIS WAIVER KNOWINGLY, VOLUNTARILY AND ONLY AFTER CONSIDERATION OF THE RAMIFICATIONS OF THIS WAIVER WITH ITS ATTORNEY.
Section 8.8. Governing Law . It is intention of the parties and it being expressly understood that this Agreement and the rights hereto are expressly governed by and are to be enforced in accordance with the laws of the State of Connecticut (but not its conflicts of law provisions), except to the extent that the UCC provides for the application of the law of the Debtor’s State.
Section 8.9. Bind and Inure . All rights and remedies of the parties under this Agreement and in connection with the Collateral shall inure to any assignee or successor of the Secured Party. All obligations of the Debtor shall bind its successors and assigns.
Section 8.10. Notices . All notices, requests or demand to or upon a party to this Agreement shall be given or made by the other party hereto, written notice mailed postage prepaid, return receipt requested, to such party at the address set forth below.
If to the Secured Party:
Department of Economic and Community Development
505 Hudson Street
Hartford, CT 06106
Attn: Commissioner
If to the Debtor:
Vermillion, Inc.
35 Nutmeg Drive, Suite 260
Trumbull, CT 06611
Attention: Chief Financial Officer
No other method of giving any notice, request or demand is hereby precluded, provided, that notice shall not be deemed given to such party until such notice is actually received at the address of the such party.
IN WITNESS WHEREOF, the Debtor and the Secured Party have duly made and entered into this Agreement as of the day and year first written above.
Signed, Sealed and Delivered DEBTOR:
in the Presence of: VERMILLION, INC.
/s/Christopher M. McKeon___________ By:_ /s/ Valerie B. Palmieri________________
Christopher M. McKeon Name: Valerie B.. Palmieri
Title: President and CEO
Duly Authorized
Dated: 3/14/16 ____________________
SECURED PARTY:
STATE OF CONNECTICUT
DEPARTMENT OF ECONOMIC
AND COMMUNITY DEVELOPMENT
/s/ Tracey Rooslund By:_ Catherine H. Smith_________________
T Rooslund Name: Catherine H. Smith
Title: Commissioner
/s/ Patricia Gillanders _________________ Duly Authorized
Patricia Gillanders
Dated: 3/22/16 _______________________________
STATE OF CONNECTICUT )
) at Trumbull
COUNTY OF FAIRFIELD )
Before me, the undersigned, this 14 th _ day of March, 2016 personally appeared Valerie B. Palmieri, known to me to be the President and CEO of Vermillion, Inc., a corporation, and that she, as such officer, signer and sealer of the foregoing instrument, acknowledged the execution of the same to be her free act and deed as such officer, and the free act and deed of said corporation.
In Witness Whereof, I hereunto set my hand.
/s/ Christopher M. McKeon _____________________
Commissioner of the Superior Court
Notary Public/My Commission Expires :
Christopher M. McKeon
STATE OF CONNECTICUT )
) at Hartford
COUNTY OF HARTFORD_ )
On this the _ 22 _ day of __ March __, 2016, before me, the undersigned, personally appeared CATHERINE H. SMITH, who acknowledged herself to be the Commissioner of the Department of Economic and Community Development and that she, as such Commissioner, being authorized so to do, executed the foregoing instrument for the purposes therein contained as her free act and deed and the free act and deed of the Department of Economic and Community Development by signing the name of the Department of Economic and Community Development by herself as such Commissioner.
In Witness Whereof I hereunto set my hand.
/s/ Tracey H. Rooslund _________________________
Commissioner of the Superior Court
Notary Public/My Commission Expires:
TRACEY H. ROOSLUND
Notary Public, State of Connecticut
My Commission Expires November 30, 2016
SCHEDULE A
Qty. Description
1 HP 42U 600x1075mm Enterprise Shock Rack
1 BW904A 001 HP Factory Express Base Racking Service
1 HP BLc7000 CTO 3 IN LCD Plat Enclosure
1 E5Y41A HP OV 3yr 24x7 Encl FIO Phys 16 Svr Lic
2 HP BL460c Gen9 10Gb/20Gb FLB CTO Blade
2 HP BL460c Gen9 E5-2695v3 FIO Kit
2 HP BL460c Gen9 E5-2695v3 Kit
32 HP 16GB 2Rx4 PC4-2133P-R Kit
2 HP FlexFabric 20Gb 2P 650FLB FIO Adptr
2 HP Smart Array P244br/1G FIO Controller
2 HP Dual 8GB microSD EM USB Kit
4 BD715A VMw vSphere EntPlus 1P 3yr SW
1 HP BL460c Gen9 10Gb/20Gb FLB CTO Blade
1 HP BL460c Gen9 E5-2695v3 FIO Kit
1 HP BL460c Gen9 E5-2695v3 Kit
16 HP 16GB 2Rx4 PC4-2133P-R Kit
1 HP FlexFabric 20Gb 2P 650FLB FIO Adptr
1 HP Smart Array P244br/1G FIO Controller
1 HP Dual 8GB microSD EM USB Kit
1 BD725A VMw vCntr Srv Std 3yr SW
2 BD715A VMw vSphere EntPlus 1P 3yr SW
2 HP BLc VC FlexFabric 10Gb/24-port Opt
4 HP 8Gb Short Wave B-Series SFP+ 1 Pack
6 HP 2650W Plat Ht Plg Pwr Supply Kit
6 HP BLc Encl Single Fan Option
1 HP BLc7000 DDR2 Encl Mgmt Option
1 HP BLc7000 10K Rack Ship Brkt Opt Kit
1 HP BLc 1PH Intelligent Power Mod FIO Opt
1 H7J34A3 7FX HP c7000 Enclosure Support
3 H7J34A3 TT8 HP BL460c Gen9 Server Blade Support
2 HP R5000 3U L630 High Voltage NA/JP UPS
2 HP R5 and 7KVA 3U Ext Runtm Mod Kit
1 HP Rack Front Door Cover Kit
1 HP 600mm Rack Stabilizer Kit
1 HP Air Flow Optimization Kit
1 HP 42U 1075mm Side Panel Kit
3 HP Intelligent Mod PDU 24a Na/Jpn Kit
8 HP BLc 10G SFP+ SFP+ 7m DAC Cable
5 HF386A1 HP CP Svc for VMware Training
1 HA124A1 56H HP Startup BladSys c7000 Encd Ntwk SVC
1 HP DL360 Gen9 8SFF CTO Server
1 HP DL360 Gen9 E5-2630v3 FIO Kit
1 HP 16GB 2Rx4 PC4-2133P-R Kit
SCHEDULE A
CONTINUED
8 HP 1TB 12G SAS 7.2K 2.5in 512e SC HDD
1 HP DL360 Gen9 SFF P440/H240 SAS Cables
1 HP Smart Array P440/4G FIO Controller
1 HP 1U SFF Easy Install Rail Kit
2 HP 500W FS Plat Ht Plg Pwr Supply Kit
1 H1K92A3 TT5 HP ProLiant DL360 Gen9 Support
1 HP StoreEasy 1450 16TB SATA Strg
1 H1K92A3 SQ4 HP StoreEasy 1450 Support
1 HP 800W/900W Gold AC Power Input Module
1 HP 3PAR StoreServ 8200 2N Fld Int Base
4 HP 3PAR 8000 1.2TB SAS 10K SFF HDD
4 HP 3PAR 8000 480GB SAS cMLC SFF SSD
1 L7B45A HP 3PAR 8200 OS Suite Base LTU
48 L7B46A HP 3PAR 8200 OS Suite Drive LTU
1 L7B47A HP 3PAR 8200 Data Opt St v2 Base LTU
48 L7B48A HP 3PAR 8200 Data Opt St v2 Drive LTU
2 HP 3PAR 8000 SFF(2.5in) Fld Int Drv Encl
8 HP 3PAR 8000 1.2TB SAS 10K SFF HDD
4 HP 3PAR 8000 480GB SAS cMLC SFF SSD
1 HP 3PAR 8000 SFF(2.5in) Fld Int Drv Encl
4 HP 3PAR 8000 1.2TB SAS 10K SFF HDD
4 HP 3PAR 8000 480GB SAS cMLC SFF SSD
1 HA114A1 5XU HP Startup 3PAR 8200 2N Fld Int Base SVC
3 HA114A1 5XZ HP Startup 3PAR 8000 Fld Int Drv Enc SVC
1 BD362AAE HP 3PAR StoreServ Mgmt/Core SW E-Media
1 BD363AAE HP 3PAR OS Suite Latest E-Media
1 H1K92A3 YT8 HP 3PAR StoreServ 8200 2N Base Supp
3 H1K92A3 YTJ HP 3PAR 8000 Drive Encl Supp
16 H1K92A3 YTV HP 3PAR 8000 1.2TB 10K SFF HDD Supp
12 H1K92A3 YTZ HP 3PAR 8000 480GB cMLC SFF SSD Supp
1 H1K92A3 YUA HP 3PAR 8200 OS Suite Base Supp
48 H1K92A3 YUB HP 3PAR 8200 OS Suite Drive Supp
1 H1K92A3 YUC HP 3PAR 8200 Data Opt St v2 Base Supp
48 H1K92A3 YUD HP 3PAR 8200 Data Opt St v2 Drive Supp
4 HP Premier Flex LC/LC OM4 2f 5m Cbl
5 HF383A1 HP CP Svc for Storage Training
2 HP HI 5500-48G-4SFP w/2 Intf Slts Switch
2 HP X240 10G SFP+ SFP+ 0.65m DAC Cable
4 HP 5500/5120 2-port 10GbE SFP+ Module
4 HP 5500 150WAC Power Supply
6 V-VBRENT-VS-P0000-00 Veeam Backup & Replication Enterprise for VMware
6 V-VBRENT-VS-P024Y-00 24/7 maintenance uplift, Veeam Backup & Replication Ent
[Schedule A Continued on Next Page]
SCHEDULE A
CONTINUED
SCHEDULE A
CONTINUED
PATENTS
COUNTRY |
STATUS |
TITLE |
APPLICATION # |
DATE FILED |
PATENT # |
TIER |
NOTES |
Australia |
Issued |
OVARIAN CANCER BIOMARKERS |
2006261904 |
Jun 23,
|
2006261904 |
1 |
OVA1 |
Australia |
Pending |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
2012220896 |
Feb 14,
|
|
1 |
OVA2 |
Australia |
Pending |
OVARIAN CANCER BIOMARKERS |
2015210343 |
Jun 23,
|
|
1 |
OVA1/2 |
Australia |
Issued |
OVARIAN CANCER BIOMARKERS |
2012216473 |
Jun 23,
|
2012216473 |
2 |
ApoA1, HE4, transthyretin |
Australia |
Pending |
PROGNOSTIC BIOMARKERS IN PATIENTS WITH OVARIAN CANCER |
2011316844 |
Oct 21,
|
|
1 |
OVA1 |
Brazil |
Published |
PREDICTIVE MARKERS FOR OVARIAN CANCER |
PI0813002.7 |
Jun 30,
|
|
1 |
Correlogic |
Canada |
Pending |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
2,828,119 |
Feb 14,
|
|
2 |
Correlogic |
Canada |
Pending |
BIOMARKERS FOR OVARIAN CANCER |
2,611,173 |
Jun 23,
|
|
2 |
Correlogic |
Canada |
Pending |
PREDICTIVE MARKERS FOR OVARIAN CANCER |
2,691,980 |
Jun 30,
|
|
2 |
Correlogic |
Canada |
Pending |
PROGNOSTIC BIOMARKERS IN PATIENTS WITH OVARIAN CANCER |
2,818,593 |
Oct 21,
|
|
1 |
OVA1 |
China |
Pending |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
201280010293.0 |
Feb 14,
|
|
2 |
Correlogic |
European Patent Office |
Issued |
BIOMARKERS FOR OVARIAN CANCER |
06773938.3 |
Jun 23,
|
1910821 |
2 |
Hepcidin |
European Patent Office |
Pending |
OVARIAN CANCER BIOMARKERS |
15173589.1 |
Jun 23,
|
|
1 |
OVA1 |
European Patent Office |
Pending |
PREDICTIVE MARKERS FOR OVARIAN CANCER |
13170474.4 |
Jun 30,
|
|
2 |
Correlogic |
European Patent Office |
Published |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
12749936.6 |
Feb 14,
|
|
2 |
Correlogic |
European Patent Office |
Published |
PROGNOSTIC BIOMARKERS IN PATIENTS WITH OVARIAN CANCER |
11835211.1 |
Oct 21,
|
|
1 |
OVA1 |
France |
Issued |
BIOMARKERS FOR OVARIAN CANCER |
06773938.3 |
Jun 23,
|
8465929 |
3 |
ApoC1 |
France |
Issued |
BIOMARKERS FOR THE DETECTION OF EARLY STAGE OVARIAN CANCER |
08843957.5 |
Oct 29,
|
7395160 |
3 |
CTAP3, ApoA1, CA125, Transthyretin |
Germany |
Issued |
BIOMARKERS FOR OVARIAN CANCER |
06773938.3 |
Jun 23,
|
8206934 |
3 |
ApoC1 |
Germany |
Issued |
BIOMARKERS FOR THE DETECTION OF EARLY STAGE OVARIAN CANCER |
08843957.5 |
Oct 29,
|
1262202 |
3 |
CTAP3, ApoA1, CA125, Transthyretin |
Germany |
Pending |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
1120120009908 |
Feb 14,
|
|
2 |
Correlogic |
Hong Kong |
Pending |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
14108246.9 |
Aug 12,
|
|
2 |
Correlogic |
India |
Pending |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
7669/CHENP/2013 |
Feb 14,
|
|
2 |
Correlogic |
India |
Pending |
PROGNOSTIC BIOMARKERS IN PATIENTS WITH OVARIAN CANCER |
3989/CHENP/2013 |
Oct 21,
|
|
1 |
OVA1 |
India |
Published |
PREDICTIVE MARKERS FOR OVARIAN CANCER |
00556/DELNP/2010 |
Jan 25,
|
|
2 |
Correlogic |
India |
Published |
PROCESS FOR DISCRIMINATING BETWEEN BIOLOGICAL STATES BASED ON HIDDEN PATTERNS FROM BIOLOGICAL DATA |
3847/KOLNP/2009 |
Nov 5,
|
|
4 |
Non-ovarian |
Japan |
Issued |
PROCESS FOR DISCRIMINATING BETWEEN BIOLOGICAL STATES BASED ON HIDDEN PATTERNS FROM BIOLOGICAL DATA |
2002-512687 |
Jul 18,
|
6925389 |
4 |
Non-ovarian |
Japan |
Pending |
BIOMARKERS FOR OVARIAN CANCER |
2014-247178 |
Jun 23,
|
|
1 |
OVA1 |
Japan |
Pending |
PROGNOSTIC BIOMARKERS IN PATIENTS WITH OVARIAN CANCER |
2013-535113 |
Oct 21,
|
|
1 |
OVA1 |
Japan |
Abandoned |
BIOMARKERS FOR OVARIAN CANCER |
2008-518478 |
Jun 23,
|
|
3 |
Calgranulin C, Transthyretin |
New Zealand |
Pending |
PROGNOSTIC BIOMARKERS IN PATIENTS WITH OVARIAN CANCER |
707493 |
Oct 21,
|
|
1 |
OVA1 |
Republic of Korea |
Published |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
10-2013-7025094 |
Feb 14,
|
|
2 |
Correlogic |
United Kingdom |
Issued |
BIOMARKERS FOR OVARIAN CANCER |
06773938.3 |
Jun 23,
|
2220506 |
3 |
ApoC1 |
United Kingdom |
Issued |
BIOMARKERS FOR THE DETECTION OF EARLY STAGE OVARIAN CANCER |
08843957.5 |
Oct 29,
|
8664358 |
3 |
CTAP3, ApoA1, CA125, Transthyretin |
United Kingdom |
Pending |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
13162227 |
Feb 14,
|
|
2 |
Correlogic |
United States of America |
Issued |
BIOMARKERS FOR OVARIAN CANCER |
12/079,592 |
Mar 27,
|
8221984 |
3 |
sMAP |
United States of America |
Issued |
BIOMARKERS FOR OVARIAN CANCER |
11/922,652 |
Dec 15,
|
2220506 |
3 |
Calcyclin;
|
United States of America |
Issued |
HEURISTIC METHOD OF CLASSIFICATION |
09/883,196 |
Jun 19,
|
7761239 |
4 |
Non-ovarian |
United States of America |
Issued |
HEURISTIC METHOD OF CLASSIFICATION |
11/735,028 |
Apr 13,
|
5246984 |
4 |
Non-ovarian |
United States of America |
Issued |
METHOD OF DIAGNOSING BIOLOGICAL STATES THROUGH THE USE OF A CENTRALIZED, ADAPTIVE MODEL, AND REMOTE SAMPLE PROCESSING |
11/008,784 |
Dec 10,
|
7096206 |
4 |
Non-ovarian |
United States of America |
Issued |
METHODS FOR DIAGNOSING OVARIAN CANCER |
12/584,832 |
Sep 11,
|
7499891 |
3 |
Protein C inhibitor |
United States of America |
Issued |
PREDICTIVE MARKERS FOR OVARIAN CANCER |
12/165,240 |
Jun 30,
|
8664358 |
2 |
ApoA1, CA125, + non OVA1/2 marker |
United States of America |
Issued |
PROCESS FOR DISCRIMINATING BETWEEN BIOLOGICAL STATES BASED ON HIDDEN PATTERNS FROM BIOLOGICAL DATA |
09/906,661 |
Jul 18,
|
6925389 |
4 |
Non-ovarian |
United States of America |
Issued |
QUALITY ASSURANCE/QUALITY CONTROL FOR ELECTROSPRAY IONIZATION PROCESSES |
10/628,136 |
Jul 28,
|
7395160 |
4 |
Non-ovarian |
United States of America |
Issued |
PREDICTIVE MARKERS FOR OVARIAN CANCER |
14/172,237 |
Feb 4,
|
92741118 |
2 |
Correlogic |
United States of America |
Pending |
BIOMARKER PANELS, DIAGNOSTIC METHODS AND TEST KITS FOR OVARIAN CANCER |
14/099,522 |
Dec 6,
|
|
2 |
Correlogic |
United States of America |
Pending |
BIOMARKERS FOR BREAST CANCER |
11/917,766 |
Dec 28,
|
|
4 |
Non-ovarian (Breast) |
United States of America |
Pending |
BIOMARKERS FOR OVARIAN CANCER |
13/916,421 |
Jun 12,
|
|
2 |
HE4, B2M, CA125, Transferrin, Transthyretin |
United States of America |
Pending |
BIOMARKERS FOR THE DETECTION OF EARLY STAGE OVARIAN CANCER |
13/909,022 |
Jun 3,
|
|
3 |
CTAP3, ApoA1, CA125, Transferrin, Transthyretin |
United States of America |
Pending |
PREDICTIVE MARKERS AND BIOMARKER PANELS FOR OVARIAN CANCER |
14/465,682 |
Aug 21,
|
|
2 |
Correlogic |
United States of America |
Pending |
PROGNOSTIC BIOMARKERS IN PATIENTS WITH OVARIAN CANCER |
14/073,668 |
Nov 6,
|
|
1 |
OVA1 |
United States of America |
Published |
OVARIAN CANCER BIOMARKERS |
11/922,621 |
Apr 13,
|
|
1 |
OVA1 |
United States of America |
Published |
PROGNOSTIC BIOMARKERS IN PATIENTS WITH OVARIAN CANCER |
12/422,530 |
Apr 13,
|
|
1 |
OVA1 |
In addition to the above described patents, machinery and equipment, all other machinery and equipment purchased and to be purchased with the proceeds of the Loan from the Secured Party to the Debtor shall also be included as collateral for purposes of this Security Agreement.
Schedule B
LIENS AND ENCUMBRANCES
NONE
Schedule C
COLLATERAL LOCATION
CORPORATION NAME: VERMILLION, INC.
TRADE NAME(S): NONE
CHIEF EXECUTIVE OFFICE LOCATION: 12117 BEE CAVES ROAD, BUILDING III, SUITE 100, AUSTIN TX 78738
PLACE(S) OF BUSINESS:
12117 BEE CAVES ROAD, BUILDING III, SUITE 100, AUSTIN TX 78738
35 NUTMEG DRIVE, SUITE 260, TRUMBULL, CT 06611
LOCATION(S) OF COLLATERAL OR RECORDS RELATING TO COLLATERAL: 35 NUTMEG DRIVE, SUITE 260, TRUMBULL, CT 06611
Certification of the Chief Executive Officer Pursuant to Section 302 of
The Sarbanes-Oxley Act Of 2002
I, Valerie B. Palmieri, certify that:
|
1. |
|
I have reviewed this quarterly report on Form 10-Q of Vermillion, Inc.; |
|
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
|
3. |
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
4. |
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5. |
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
Date: May 1 6 , 201 6 |
/s/ Valerie B. Palmieri |
|
Valerie B. Palmieri President and Chief Executive Officer |
Certification of the Chief Accounting Officer Pursuant to Section 302 of
The Sarbanes-Oxley Act Of 2002
I, Eric J. Schoen, certify that:
|
1. |
|
I have reviewed this quarterly report on Form 10-Q of Vermillion, Inc.; |
|
2. |
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
|
3. |
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
4. |
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5. |
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
Date: May 1 6 , 201 6 |
/s/ Eric J. Schoen |
|
Eric J. Schoen Vice President, Finance and Chief Accounting Officer |
Certification of the Chief Executive Officer and Vice President, Finance and Chief Accounting Officer
Pursuant to 18 U.S.C. Section 1350,
as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
with Respect to the Quarterly Report on Form 10-Q
for the Period Ended March 31 , 201 6
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, Chapter 63 of Title 18, United States Code), each of the undersigned officers of Vermillion, Inc., a Delaware corporation (the “Company”), does hereby certify, to the best of such officer’s knowledge, that:
|
1. |
|
The Company’s quarterly report on Form 10-Q for the period ended March 31 , 201 6 , (the “Form 10-Q”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
|
2. |
|
Information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company. |
|
|
Date: May 16, 201 6 |
/s/ Valerie B. Palmieri |
|
Valerie B. Palmieri President and Chief Executive Officer (Principal Executive Officer) |
|
|
Date: May 16, 2016 |
/s/ Eric J. Schoen |
|
Eric J. Schoen Vice President, Finance and Chief Accounting Officer (Principal Financial Officer) |
The certification set forth above is being furnished as an Exhibit solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and is not being filed as part of the Form 10-Q or as a separate disclosure document of the Company or the certifying officers.