UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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 June 30, 2018

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from           to           

Commission file number: 001-36536

 

CAREDX, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

94-3316839

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification Number)

 

3260 Bayshore Boulevard

Brisbane, California 94005

(Address of principal executive offices and zip code)

(415) 287-2300

(Registrant’s telephone number, including area code)

N/A

(Former name, former address and former fiscal year, if changed since last report)

 

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, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

 

Accelerated filer

 

 

 

 

 

 

 

 

Non-accelerated filer

 

(Do not check if a smaller reporting company)

 

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes   No

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.

There were 36,346,124 shares of the registrant’s Common Stock issued and outstanding as of August 6, 2018.

 

 

 

 

 

 


 

CareDx, Inc.

TABLE OF CONTENTS

 

 

 

Page No.

PART I. FINANCIAL INFORMATION

 

3

Item 1. Unaudited Condensed Consolidated Financial Statements

 

3

Condensed Consolidated Balance Sheets as of June 30, 2018 and December 31, 2017

 

3

Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2018 and 2017

 

4

Condensed Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2018 and 2017

 

5

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2018 and 2017

 

6

Notes to Unaudited Condensed Consolidated Financial Statements

 

7

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

32

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

46

Item 4. Controls and Procedures

 

47

 

 

 

PART II. OTHER INFORMATION

 

48

Item 1. Legal Proceedings

 

48

Item 1A. Risk Factors

 

48

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

49

Item 3. Defaults Upon Senior Securities

 

49

Item 5. Other Information

 

49

Item 6. Exhibits

 

49

Signatures

 

51

 

 

 

 

2


 

PART I. FINANCI AL INFORMATION

ITEM 1.

UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

CareDx, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands, except share data)

 

 

June 30, 2018

 

 

December 31, 2017

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

16,246

 

 

$

16,895

 

Accounts receivable

 

 

8,072

 

 

 

2,991

 

Inventory

 

 

4,666

 

 

 

5,529

 

Prepaid and other assets

 

 

1,593

 

 

 

1,352

 

Total current assets

 

 

30,577

 

 

 

26,767

 

Property and equipment, net

 

 

2,360

 

 

 

2,075

 

Intangible assets, net

 

 

34,760

 

 

 

33,139

 

Goodwill

 

 

12,005

 

 

 

12,005

 

Restricted cash

 

 

177

 

 

 

9,579

 

Total assets

 

$

79,879

 

 

$

83,565

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,480

 

 

$

3,391

 

Accrued payroll liabilities

 

 

5,576

 

 

 

5,013

 

Accrued and other liabilities

 

 

4,703

 

 

 

3,735

 

Deferred revenue

 

 

39

 

 

 

39

 

Deferred purchase consideration

 

 

378

 

 

 

407

 

Derivative liability

 

 

 

 

 

14,600

 

Current debt

 

 

 

 

 

15,721

 

Total current liabilities

 

 

14,176

 

 

 

42,906

 

Deferred rent, net of current portion

 

 

686

 

 

 

913

 

Deferred revenue, net of current portion

 

 

711

 

 

 

730

 

Deferred tax liability

 

 

3,693

 

 

 

4,933

 

Long-term debt, net of current portion

 

 

13,337

 

 

 

18,338

 

Contingent consideration

 

 

 

 

 

1,672

 

Common stock warrant liability

 

 

16,800

 

 

 

18,712

 

Other liabilities

 

 

1,524

 

 

 

1,315

 

Total liabilities

 

 

50,927

 

 

 

89,519

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock: $0.001 par value; 10,000,000 shares authorized at June 30, 2018

   and December 31, 2017; no shares issued and outstanding at June 30, 2018

   and December 31, 2017

 

 

 

 

 

 

Common stock: $0.001 par value; 100,000,000 shares authorized at June 30, 2018

   and December 31, 2017; 35,975,493 shares and 28,825,019 shares issued and

   outstanding at June 30, 2018 and December 31, 2017, respectively

 

 

36

 

 

 

29

 

Additional paid-in capital

 

 

321,144

 

 

 

264,204

 

Accumulated other comprehensive loss

 

 

(4,108

)

 

 

(2,345

)

Accumulated deficit

 

 

(288,120

)

 

 

(268,022

)

Total CareDx, Inc. stockholders' equity (deficit)

 

 

28,952

 

 

 

(6,134

)

Noncontrolling interest

 

 

 

 

 

180

 

Total stockholders’ equity (deficit)

 

 

28,952

 

 

 

(5,954

)

Total liabilities and stockholders’ equity

 

$

79,879

 

 

$

83,565

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

3


 

CareDx, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share data)

 

 

 

Three   Months Ended June 30,

 

 

Six   Months Ended June 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Testing services revenue

 

$

13,997

 

 

$

8,420

 

 

$

24,601

 

 

$

16,322

 

Product revenue

 

 

3,550

 

 

 

3,376

 

 

 

6,857

 

 

 

7,043

 

License and other revenue

 

 

276

 

 

 

250

 

 

 

418

 

 

 

265

 

Total revenue

 

 

17,823

 

 

 

12,046

 

 

 

31,876

 

 

 

23,630

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of testing services

 

 

4,568

 

 

 

3,011

 

 

 

8,680

 

 

 

6,068

 

Cost of product

 

 

2,639

 

 

 

2,178

 

 

 

4,911

 

 

 

4,505

 

Research and development

 

 

3,496

 

 

 

3,118

 

 

 

6,864

 

 

 

6,401

 

Sales and marketing

 

 

5,860

 

 

 

3,270

 

 

 

9,945

 

 

 

6,492

 

General and administrative

 

 

5,596

 

 

 

4,132

 

 

 

10,903

 

 

 

10,634

 

Goodwill impairment

 

 

 

 

 

 

 

 

 

 

 

1,958

 

Change in estimated fair value of contingent consideration

 

 

873

 

 

 

(64

)

 

 

1,017

 

 

 

(285

)

Total operating expenses

 

 

23,032

 

 

 

15,645

 

 

 

42,320

 

 

 

35,773

 

Loss from operations

 

 

(5,209

)

 

 

(3,599

)

 

 

(10,444

)

 

 

(12,143

)

Interest expense

 

 

(424

)

 

 

(1,691

)

 

 

(3,119

)

 

 

(2,481

)

Other expense, net

 

 

(42

)

 

 

(188

)

 

 

(2,851

)

 

 

(874

)

Change in estimated fair value of common stock warrant liability and derivative liability

 

 

(8,768

)

 

 

1,067

 

 

 

(7,447

)

 

 

5,195

 

Loss before income taxes

 

 

(14,443

)

 

 

(4,411

)

 

 

(23,861

)

 

 

(10,303

)

Income tax benefit

 

 

381

 

 

 

376

 

 

 

805

 

 

 

659

 

Net loss

 

 

(14,062

)

 

 

(4,035

)

 

 

(23,056

)

 

 

(9,644

)

Net loss attributable to noncontrolling interest

 

 

 

 

 

(67

)

 

 

(25

)

 

 

(114

)

Net loss attributable to CareDx, Inc.

 

$

(14,062

)

 

$

(3,968

)

 

$

(23,031

)

 

$

(9,530

)

Net loss per share attributable to CareDx, Inc. (Note 3):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.40

)

 

$

(0.19

)

 

$

(0.71

)

 

$

(0.45

)

Diluted

 

$

(0.40

)

 

$

(0.19

)

 

$

(0.71

)

 

$

(0.45

)

Weighted average shares used to compute net loss per share attributable to CareDx, Inc.:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

35,549,837

 

 

 

21,412,480

 

 

 

32,599,032

 

 

 

21,378,321

 

Diluted

 

 

35,549,837

 

 

 

21,412,480

 

 

 

32,599,032

 

 

 

21,378,321

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

4


 

CareDx, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(Unaudited)

(In thousands)

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Net loss

 

$

(14,062

)

 

$

(4,035

)

 

$

(23,056

)

 

$

(9,644

)

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

(1,625

)

 

 

670

 

 

 

(1,762

)

 

 

934

 

Net comprehensive loss

 

 

(15,687

)

 

 

(3,365

)

 

 

(24,818

)

 

 

(8,710

)

Comprehensive loss attributable to noncontrolling interest, net of tax

 

 

 

 

 

(72

)

 

 

(25

)

 

 

(124

)

Comprehensive loss attributable to CareDx, Inc.

 

$

(15,687

)

 

$

(3,293

)

 

$

(24,793

)

 

$

(8,586

)

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

5


 

CareDx, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

 

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

Operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(23,056

)

 

$

(9,644

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

2,025

 

 

 

1,821

 

Amortization of inventory fair market value adjustment

 

 

189

 

 

 

170

 

Loss on conversion of JGB debt to shares of common stock

 

 

2,806

 

 

 

 

Amortization of debt discount and noncash interest expense

 

 

2,132

 

 

 

1,769

 

Revaluation of common stock warrant liability and derivative liability to estimated fair value

 

 

7,447

 

 

 

(5,195

)

Stock-based compensation

 

 

3,217

 

 

 

886

 

Revaluation of contingent consideration to estimated fair value

 

 

1,017

 

 

 

(285

)

Goodwill impairment charge

 

 

 

 

 

1,958

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(2,280

)

 

 

(152

)

Inventory

 

 

333

 

 

 

252

 

Prepaid and other assets

 

 

(296

)

 

 

(189

)

Accounts payable

 

 

195

 

 

 

422

 

Accrued payroll liabilities

 

 

686

 

 

 

(486

)

Accrued and other liabilities

 

 

92

 

 

 

(710

)

Change in deferred revenue

 

 

(19

)

 

 

(12

)

Change in deferred taxes

 

 

(892

)

 

 

(542

)

Net cash used in operating activities

 

 

(6,404

)

 

 

(9,937

)

Investing activities:

 

 

 

 

 

 

 

 

Acquisition of intangible assets through Illumina Licensing Agreement

 

 

(5,202

)

 

 

 

Acquisition of Allenex AB minority interest

 

 

(692

)

 

 

 

Purchase of property and equipment

 

 

(461

)

 

 

(94

)

Net cash used in investing activities

 

 

(6,355

)

 

 

(94

)

Financing activities:

 

 

 

 

 

 

 

 

Proceeds from debt, net of issuance costs

 

 

14,282

 

 

 

24,002

 

Proceeds from issuance of common stock under employee stock purchase plan

 

 

32

 

 

 

44

 

Principal payments on debt and capital lease obligations

 

 

(11,349

)

 

 

(12,871

)

Acquisition of Conexio Genomics Pty Ltd.

 

 

(91

)

 

 

 

Change in short term credit facility

 

 

(677

)

 

 

176

 

Proceeds from exercise of warrants

 

 

524

 

 

 

 

Repurchases of common stock under employee incentive plans

 

 

(142

)

 

 

 

Proceeds from exercise of stock options

 

 

179

 

 

 

 

Net cash provided by financing activities

 

 

2,758

 

 

 

11,351

 

Effect of exchange rate changes on cash and cash equivalents

 

 

(50

)

 

 

(64

)

Net increase (decrease) in cash, cash equivalents and restricted cash

 

 

(10,051

)

 

 

1,256

 

Cash, cash equivalents, and restricted cash at beginning of period

 

 

26,474

 

 

 

17,401

 

Cash, cash equivalents, and restricted cash at end of period

 

$

16,423

 

 

$

18,657

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

Deferred purchase consideration

 

$

 

 

$

1,064

 

Contingent consideration shares issued

 

 

2,689

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash, Cash Equivalents and Restricted Cash as of:

 

June 30, 2018

 

 

December 31, 2017

 

Cash and cash equivalents

 

$

16,246

 

 

$

16,895

 

Restricted cash

 

 

177

 

 

 

9,579

 

Total cash, cash equivalents and restricted cash at the end of period

 

$

16,423

 

 

$

26,474

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

6


 

CareDx, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

 

 

1. ORGANIZATION AND DESCRIPTION OF BUSINESS

CareDx, Inc. (“CareDx” or the “Company”) together with its subsidiaries, is a global transplant diagnostics company with product offerings along the pre- and post-transplant continuum.  The Company focuses on discovery, development and commercialization of clinically differentiated, high-value diagnostic surveillance solutions for transplant patients.  In diagnostic testing services, the Company offers AlloMap®, which is a gene expression solution for heart transplant patients and AlloSure®, which is a donor-derived cell free DNA (“dd-cfDNA”) solution initially used for kidney transplant patients.  The Company also offers high quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs.

AlloMap is a gene expression test that helps clinicians monitor and identify heart transplant recipients with stable graft function who have a low probability of moderate to severe acute cellular rejection.  Since 2008, the Company has sought to expand the adoption and utilization of its AlloMap solution through ongoing studies to substantiate the clinical utility and actionability of AlloMap, secure positive reimbursement decisions for AlloMap from large private and public payers, develop and enhance its relationships with key members of the transplant community, including opinion leaders at major transplant centers, and explore opportunities and technologies for the development of additional solutions for post-transplant surveillance.  The Company believes the use of AlloMap, in conjunction with other clinical indicators, can help healthcare providers and their patients better manage long-term care following a heart transplant. In particular, the Company believes AlloMap can improve patient care by helping healthcare providers avoid the use of unnecessary, invasive surveillance biopsies and determine the appropriate dosage levels of immunosuppressants. AlloMap has received 510(k) clearance from the U.S. Food and Drug Administration (the “FDA”) for marketing and sale as a test to aid in the identification of recipients with a low probability of moderate or severe acute cellular rejection.  A 510(k) submission is a premarketing submission made to the FDA. Clearance may be granted by the FDA if it finds the device or test provides satisfactory evidence pertaining to the claimed intended uses and indications for the device or test.

On October 9, 2017, the Company commercially launched AlloSure, its proprietary next-generation sequencing-based test to measure dd-cfDNA after transplantation. The Company believes the use of AlloSure, in conjunction with other clinical indicators, can help healthcare providers and their patients better manage long-term care following a kidney transplant. In particular, the Company believes AlloSure can improve patient care by helping healthcare providers to reduce the use of invasive biopsies and determine the appropriate dosage levels of immunosuppressants.

The Company also develops, manufactures, markets and sells products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs.  Olerup SSP® is used to type Human Leukocyte Antigen (“HLA”) alleles, based on the sequence specific primer (“SSP”) technology.  Olerup SBT TM is a complete product range for sequence-based typing of HLA alleles. Olerup QTYPE® enables speed and precision in HLA typing at a low to intermediate resolution for samples that require a fast turn-around-time and uses real-time polymerase chain reaction, or PCR methodology. QTYPE received CE mark certification on April 10, 2018.  

On May 4, 2018, the Company entered into a License and Commercialization Agreement with Illumina, Inc. (“Illumina”), which provides the Company with worldwide distribution, development and commercialization rights to Illumina’s next generation sequencing (“NGS”) product line for use in transplantation diagnostic testing.

The Company’s headquarters are in Brisbane, California; primary operations are in Brisbane, U.S. and Stockholm, Sweden; and the Company operates in two reportable segments.

Liquidity and Going Concern

The Company has incurred significant losses and negative cash flows from operations since its inception and had an accumulated deficit of $288.1 million at June 30, 2018. As of June 30, 2018, the Company had cash and cash equivalents of $16.2 million, and $13.3 million of debt outstanding, net of debt discount, under its debt obligations, of which none is current.

On April 17, 2018, the Company entered into a credit agreement with Perceptive Credit Holdings II, LP (“Perceptive ”) for an initial term loan of $15.0 million (“the Perceptive Credit Agreement”) and repaid the outstanding indebtedness of the promissory notes previously issued to FastPartner AB and Mohammed Al Amoudi and the term loan and credit facility with Danske Bank A/S (“Danske”).  A second tranche of $10.0 million will be available at the Company’s option subject to the satisfaction of customary conditions. Refer to Note 10 for additional details.

7


 

The Company may req uire additional financing in the future to fund working capital and pay its obligations as they come due.  Additional financing might include issuance of equity securities, debt, cash from collaboration agreements or a combination of these.  However, there can be no assurance that the Company will be successful in acquiring additional funding at levels sufficient to fund its operations or on terms favorable to the Company. The Company believes its existing cash balance and expected revenues will be sufficie nt to meet its anticipated cash requirements for at least the next 12 months.

 

 

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The significant accounting policies and estimates used in preparation of the unaudited condensed consolidated financial statements are described in the Company’s audited consolidated financial statements as of and for the year ended December 31, 2017, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K. Material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017 are reflected below.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and follow the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting.  As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted.  These financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of the Company’s financial information.  The condensed consolidated balance sheet as of December 31, 2017 has been derived from audited financial statements as of that date but does not include all of the financial information required by U.S. GAAP for complete financial statements.  Operating results for the three and six months ended June 30, 2018 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018.

The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its subsidiaries. Intercompany transactions have been eliminated.  The Company acquired CareDx International AB, formerly Allenex AB “Allenex”, on April 14, 2016.  Since the acquisition of Allenex through March 15, 2018, the Company owned less than 100% of the shares of Allenex and recorded a net loss attributable to noncontrolling interest in its condensed consolidated statements of operations equal to the percentage of the economic or ownership interest retained by the respective noncontrolling parties in such entities.  On March 15, 2018, the Company acquired the remaining noncontrolling interest in Allenex and has not reported any noncontrolling interest balances since this date.

Use of Estimates

The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the unaudited condensed consolidated financial statements and accompanying notes.  On an ongoing basis, management evaluates its estimates, including those related to (i) variable transaction price consideration related to contracts with customers, (ii) the determination of the accruals for clinical studies, (iii) the fair value of assets and liabilities acquired in business combinations, including contingent consideration, (iv) inventory valuation, (v) the valuation of common stock warrant liability, (vi) the fair value of embedded derivatives, (vii) measurement of stock-based compensation expense, (viii) the determination of the valuation allowance and estimated tax benefit associated with deferred tax assets and net deferred tax liability, (ix) any impairment of long-lived assets, including in-process technology and goodwill, and (x) legal contingencies.  Actual results could differ from those estimates.

Concentrations of Credit Risk and Other Risks and Uncertainties

For the six months ended June 30, 2018 and 2017, approximately 45% and 28%, respectively, of total revenue was derived from Medicare. No other payers or customers represented more than 10% of total revenue for these periods.

At June 30, 2018 and December 31, 2017, approximately 24% and 16%, respectively, of accounts receivable was due from Medicare.  No other payer or customer represented more than 10% of accounts receivable on either June 30, 2018 or December 31, 2017.

Restricted Cash

A restricted cash balance of $9.4 million was released upon the full conversion of the debt obligation to JGB Collateral LLC and certain of its affiliates (“JGB”) (refer to Note 10) during the three months ended March 31, 2018 and is no longer classified as restricted cash.

As a condition of the lease agreements for certain facilities and an agreement with the State of Florida Medicaid, the Company must maintain letters of credit, minimum collateral requirements and a surety bond.  These agreements are collateralized by cash.  The cash

8


 

use d to support these arrangements is classified as long-term restricted cash on the accompanying condensed consolidated balance sheets.

Common Stock Warrant Liability and Derivative Liability

Common Stock Warrant Liability

On January 1, 2018, the Company adopted Accounting Standard Update (“ASU”) No. 2017-11, Accounting for Certain Financial Instruments with Down Round Features and Replacement of the Indefinite Deferral of Mandatorily Redeemable Financial Instruments of Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception.   The Company determined that the common stock warrants issued to JGB (the “JGB Warrants”) meet equity classification criteria under the new standard and reclassified $6.6 million (the fair value of the JGB warrants as of January 1, 2018) from warrant liability to equity (additional paid in capital). The warrant issued to Perceptive (the “Perceptive Tranche A Warrant”), on April 17, 2018, also met the equity classification as noted in Note 13.The new standard did not impact the classification of the other warrants included in the warrant liability balance as these financial instruments have other than down-round anti-dilution adjustments features.

Derivative Liability

The convertible debt financing with JGB (the “JGB Debt”), included certain embedded derivatives that required bifurcation, including settlement and penalty provisions.  The combined embedded derivative was remeasured at each reporting period with changes recorded in change in estimated fair value of common stock warrant liability and derivative liability in the condensed consolidated statements of operations.  As of March 27, 2018, the JGB Debt was fully converted to shares of the Company’s common stock.  The change in the fair market value of the derivative liability through March 27, 2018 was recorded in change in estimated fair value of common stock warrant liability and derivative liability in the condensed consolidated statements of operations.

On April 17, 2018, the Company entered into the Perceptive Credit Agreement, which included an embedded derivative that required bifurcation related to early repayment provision. This embedded derivative fair value of $0.2 million was recorded as debt issuance discount. Refer to Note 10 for additional details.  The derivative is remeasured at the end of each reporting period if debt remains outstanding with changes recorded in change in estimated fair value of common stock warrant liability and derivative liability in the condensed consolidated statements of operations.

Revenue

The Company recognizes revenue from testing services, products, and license and other revenue in the amount that reflects the consideration which it expects to be entitled in exchange for goods or services as it transfers control to its customers.   Revenue is recorded considering a five-step model that includes identifying the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating the transaction price to the performance obligations, and recognizing revenue when, or as, an entity satisfies a performance obligation.

Testing Services Revenue

AlloMap and AlloSure patient tests are ordered by healthcare providers.  The Company receives a test requisition form with payer information along with a collected patient blood sample. The Company considers the patient to be its customer and the test requisition form a contract. Testing services are performed in the Company’s laboratory. Testing services represent one performance obligation in a contract and are performed when results of the test are provided to the healthcare provider, at a point of time.

The healthcare providers that order the tests and on whose behalf CareDx provides testing services are generally not responsible for the payment of these services.  The first and second revenue recognition criteria are satisfied when the Company receives a test requisition form with payer information from the healthcare provider.  Generally, the Company bills third-party payers upon delivery of an AlloMap or AlloSure test result to the healthcare provider. Amounts received may vary amongst payers based on coverage practices and policies of the payer.  The Company has used the portfolio approach, a practical expedient under Accounting Standards Codifications (“ASC”) Topic 606, to identify financial classes of payers. Transaction prices are determined for each financial class using history of reimbursements, including analysis of an average reimbursement per test and a percentage of tests reimbursed. The Company estimates revenue for non-contracted payers and self-payers using this methodology.  The estimate requires significant judgment. Revenue recognized for Medicare and other contracted payers is based on the agreed current reimbursement rate per test, adjusted for historical collection trends where applicable.

The Company monitors revenue estimates at each reporting period based on actual cash collections in order to assess whether a revision to the estimate is required. Changes in transaction price estimates are updated quarterly based on actual cash collected or changes made to contracted rates.

9


 

Product Revenue

Product revenue is recognized from the sale of products to end-users, distributors and strategic partners when all revenue recognition criteria are satisfied.  The Company generally has a contract or a purchase order from a customer with the specified required terms of order, including the number of products ordered. Transaction prices are determinable and products are delivered and risk of loss passed to the customer upon either shipping or delivery, as per the terms of the agreement. There are no further performance obligations related to a contract and revenue is recognized at the point of delivery consistent with the terms of the contract or purchase order.

License and Other Revenue

The Company generates revenue from license agreements.  License agreements may include non-refundable upfront payments, partial or complete reimbursement of research and development costs, contingent payments based on the occurrence of specified events under the agreements, license fees and royalties on sales of products or product candidates if they are successfully commercialized.  The Company’s performance obligations under the agreements may include the transfer of intellectual property rights in the form of licenses, obligations to provide research and development services and obligations to participate on certain development committees.  The Company makes judgments to determine if performance obligations are distinct or should be combined and the transaction price allocated to each performance obligation, which affect the periods over which revenue is recognized.  The Company periodically reviews its estimated periods of performance based on the progress under each arrangement and accounts for the impact of any change in estimated periods of performance on a prospective basis. The Company constrains variable consideration, such as milestones, if it is probable that a significant portion of revenue would be reversed. The Company’s deferred revenue relates to one performance obligation, which should be recognized over time.

The Company did not recognize any revenue connected with milestones during the three or six months ended June 30, 2018 or 2017.

Cost of Testing Services

Cost of testing services reflects the aggregate costs incurred in delivering the Company’s testing services.  The components of cost of testing are materials and service costs, direct labor costs, stock-based compensation, equipment and infrastructure expenses associated with testing samples, shipping, logistics and specimen processing charges to collect and transport samples, and allocated overhead including rent, information technology, equipment depreciation, utilities and royalties.  Prior to adoption of the new revenue guidance, the Company recorded costs of testing associated with performing tests (except royalties) in the period when tests were performed without consideration of whether revenue was recognized in the same period.  With the adoption of the new revenue standard on January 1, 2018, revenue and cost of testing for tests performed are recognized in the same period. Royalties for licensed technology, calculated as a percentage of test revenues, are recorded as license fees in cost of testing services at the time the test revenues are recognized.

Recent Accounting Pronouncements

On January 1, 2018, the Company adopted the new revenue accounting standard Revenue from Contracts with Customers (Topic 606) ("ASC 606") using the modified retrospective method. The adoption of ASC 606 resulted in a one-time adjustment of $2.9 million to accounts receivable and retained earnings on January 1, 2018.  The adjustment reflects the estimated payments to be received for tests where the result had been delivered at December 31, 2017, but associated revenue had not been recognized by December 31, 2017, because payment had not been received. The new standard did not impact the Company’s product revenue or license and other revenue, nor did it impact contract assets or contract liabilities.

The following table summarizes the impact of the ASC 606 adoption on accounts receivable as of June 30, 2018 (in thousands):

 

 

Balance as Reported

 

 

Balance without the adoption of ASC 606

 

 

Impact of Adoption of ASC 606

 

Balance Sheets

 

 

 

 

 

 

 

 

 

 

 

 

Accounts Receivable

 

$

8,072

 

 

$

4,564

 

 

$

3,508

 

The following table summarizes the impact to the statement of operations in accordance with the new revenue standard requirements for the three and six months ended June 30, 2018 (in thousands):

10


 

 

 

Three Months Ended June 30, 2018

 

 

 

Balance As Reported

 

 

Balance without the adoption of ASC 606

 

 

Revenue Impact of adoption of ASC 606

 

Statements of Operations

 

 

 

 

 

 

 

 

 

 

 

 

Testing revenue

 

$

13,997

 

 

$

13,484

 

 

$

513

 

Product revenue

 

 

3,550

 

 

 

3,550

 

 

 

 

License and other revenue

 

 

276

 

 

 

276

 

 

 

 

 

 

$

17,823

 

 

$

17,310

 

 

$

513

 

 

 

 

Six Months Ended June 30, 2018

 

 

 

Balance As Reported

 

 

Balance without the adoption of ASC 606

 

 

Revenue Impact of adoption of ASC 606

 

Statements of Operations

 

 

 

 

 

 

 

 

 

 

 

 

Testing revenue

 

$

24,601

 

 

$

24,076

 

 

$

525

 

Product revenue

 

 

6,857

 

 

 

6,857

 

 

 

 

License and other revenue

 

 

418

 

 

 

418

 

 

 

 

 

 

$

31,876

 

 

$

31,351

 

 

$

525

 

In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-02,  Leases (Topic 842), which, for operating leases, requires the lessee to recognize a right-of-use asset and a lease liability, initially measured at the present value of the lease payments, in its balance sheet.  The guidance also requires a lessee to recognize single lease costs, calculated so that the cost of the lease is allocated over the lease term, generally on a straight-line basis.  In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842, Leases. Additionally, the FASB issued ASU, No. 2018-11, Leases (Topic 842): Targeted Improvements , which offers a practical expedient for transitioning at the adoption date. These ASUs will be effective for the Company on January 1, 2019 and the Company has chosen to use the practical expedient and recognize a cumulative-effect adjustment to the opening balance of the retained earnings.  The Company has created an implementation plan and is in the early stages of assessing the impact of the guidance on its consolidated financial statements.  

In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (a consensus of the Emerging Issues Task Force) (“ASU 2016-15”), to reduce the diversity in practice with respect to the presentation of certain cash flows.  The ASU is effective for interim and annual periods beginning after December 15, 2017.  The Company adopted ASU 2016-15 on January 1, 2018 on a retrospective basis.  The adoption of ASU 2016-15 did not have a material impact on the Company’s condensed consolidated financial statements.

In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (a consensus of the FASB Emerging Issues Task Force) (“ASU 2016-18”) .   This guidance requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents.  Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for all interim and annual reporting periods beginning after December 15, 2017.  The Company adopted ASU 2016-18 on January 1, 2018 on a retrospective basis and included restricted cash together with cash and cash equivalents in its condensed consolidated statements of cash flows.

In May 2017, the FASB issued ASU No. 2017-09, Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting (“ASU 2017-09”).  The amendments provide guidance about how to account for changes to terms or conditions of a share-based payment award required under modification accounting.  ASU 2017-09 is effective for all interim and annual reporting periods beginning after December 15, 2017. The Company adopted ASU 2017-09 on January 1, 2018 on a prospective basis and the adoption of ASU 2017-09 did not have a material impact to the condensed consolidated financial statements.

In July 2017, the FASB issued ASU No. 2017-11, Accounting for Certain Financial Instruments with Down Round Features and Replacement of the Indefinite Deferral of Mandatorily Redeemable Financial Instruments of Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”). ASU 2017-11 is effective for all interim and annual reporting periods beginning on or after December 15, 2018 with early adoption permitted.  The Company adopted ASU 2017-11 on January 1, 2018, and the adoption resulted in the JGB common stock warrant liability balance being reclassified to additional paid in capital (Refer to Note 13).  

11


 

In February 2018, the FASB issued ASU No. 2 018-02, Income Statement – Reporting Comprehensive Income (Topic 220):  Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income (“ASU 2018-02”) .   The amendments in ASU 2018-02 allow a reclassification from accumulated other comp rehensive income to retained earnings for certain tax effects resulting from the Tax Cuts and Jobs Act (the “Tax Act”).  The Company is still reviewing the Tax Act and its impact to the condensed consolidated financial statements. ASU 2018-02 will become e ffective for all interim and annual reporting periods beginning after December 15, 2018 and may be applied retrospectively or as of the beginning of the period of adoption.

In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share Based Payment Accounting (“ASU 2018-07”). ASU 2018-07 is effective for all interim and annual reporting periods beginning on or after December 15, 2018. The Company will adopt ASU 2018-07 on January 1, 2019 and does not expect the adoption to have a material impact to the condensed consolidated financial statements.      

 

 

3. NET LOSS PER SHARE

Basic and diluted net loss per share have been computed by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common share equivalents as their effect would have been antidilutive.

The following tables set forth the computation of the Company’s basic and diluted net loss per share (in thousands, except shares and per share data):

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss attributable to CareDx, Inc. used to compute basic

  and diluted net loss per share

 

$

(14,062

)

 

$

(3,968

)

 

$

(23,031

)

 

$

(9,530

)

Denominator:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares used to compute basic and diluted

   net loss per share attributable to CareDx, Inc.

 

 

35,549,837

 

 

 

21,412,480

 

 

 

32,599,032

 

 

 

21,378,321

 

Net loss per share attributable to CareDx, Inc.:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.40

)

 

$

(0.19

)

 

$

(0.71

)

 

$

(0.45

)

The following potentially dilutive securities have been excluded from diluted net loss per share, because their effect would be antidilutive:

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Shares of common stock subject to outstanding options

 

 

2,561,458

 

 

 

1,898,389

 

 

 

2,561,458

 

 

 

1,898,389

 

Shares of common stock subject to outstanding common

   stock warrants

 

 

3,328,089

 

 

 

4,509,926

 

 

 

3,328,089

 

 

 

4,509,926

 

Shares of common stock subject to convertible notes

 

 

 

 

 

6,092,105

 

 

 

 

 

 

6,092,105

 

Shares of common stock subject to contingent consideration

 

 

 

 

 

227,845

 

 

 

 

 

 

227,845

 

Restricted stock units

 

 

896,904

 

 

 

353,807

 

 

 

896,904

 

 

 

353,807

 

Total common stock equivalents

 

 

6,786,451

 

 

 

13,082,072

 

 

 

6,786,451

 

 

 

13,082,072

 

 

On October 10, 2017, the Company completed an underwritten public offering (the “2017 Public Offering”), pursuant to which the Company issued and sold an aggregate of 4,992,840 shares.  During 2017 and the three months ended March 31, 2018, 6,415,039 shares of common stock subject to convertible notes were issued due to the conversion of the JGB Debt.  In the three months ended June 30, 2018, the Company achieved the milestone of performing 2,500 commercial AlloSure tests; therefore, the Company issued 227,845 shares of common stock to the former owners of ImmuMetrix, Inc. (“IMX”) that was previously considered contingent consideration.  

The Perceptive Credit Agreement includes a Tranche B loan of $10.0 million available at the Company’s option at any time from April 17, 2018 to April 17, 2019 (the “Tranche B Term Loan”). If the Tranche B Term Loan is funded, the Company will issue to Perceptive an additional warrant to purchase up to 93,333 shares of common stock.

 

 

 

12


 

4. FAIR VALUE MEASUREMENTS

The Company records its financial assets and liabilities at fair value except for its debt, which was recorded at amortized cost.  The carrying amounts of certain financial instruments of the Company, including cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities.  Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date.  The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:

 

Level 1: Inputs which include quoted prices in active markets for identical assets and liabilities.

 

Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

 

Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The following table sets forth the Company’s financial assets and liabilities measured at fair value on a recurring basis, as of June 30, 2018 and December 31, 2017 (in thousands):

 

 

 

June 30, 2018

 

 

 

Fair Value Measured Using

 

 

 

 

 

 

 

(Level 1)

 

 

(Level 2)

 

 

(Level 3)

 

 

Total

Balance

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

12,958

 

 

$

 

 

$

 

 

$

12,958

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common stock warrant liability

 

 

 

 

 

 

 

 

16,800

 

 

 

16,800

 

Perceptive derivative liability

 

 

 

 

 

 

 

 

235

 

 

 

235

 

Total liabilities

 

$

 

 

$

 

 

$

17,035

 

 

$

17,035

 

 

 

 

December 31, 2017

 

 

 

Fair Value Measured Using

 

 

 

 

 

 

 

(Level 1)

 

 

(Level 2)

 

 

(Level 3)

 

 

Total

Balance

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

13,097

 

 

$

 

 

$

 

 

$

13,097

 

Liabilities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contingent consideration

 

$

 

 

$

 

 

$

1,672

 

 

$

1,672

 

Common stock warrant liability

 

 

 

 

 

 

 

 

18,712

 

 

 

18,712

 

JGB derivative liability

 

 

 

 

 

 

 

 

14,600

 

 

 

14,600

 

Total liabilities

 

$

 

 

$

 

 

$

34,984

 

 

$

34,984

 

The following table presents the issuances, changes in fair value and reclassifications of the Company’s Level 3 financial instruments that are measured at fair value on a recurring basis (in thousands):

 

 

 

(Level 3)

 

 

 

Contingent

Consideration

Liability

 

 

Common   Stock Warrant Liability

 

 

JGB Derivative

Liability

 

 

Perceptive Derivative Liability

 

 

Total

 

Balance as of December 31, 2017

 

$

1,672

 

 

$

18,712

 

 

$

14,600

 

 

 

 

 

$

34,984

 

Exercise of warrants

 

 

 

 

 

(127

)

 

 

 

 

 

 

 

 

(127

)

Conversion of JGB debt to common stock (Note 10)

 

 

 

 

 

 

 

 

(12,066

)

 

 

 

 

 

(12,066

)

Reclassification to equity (Note 2)

 

 

 

 

 

(6,550

)

 

 

 

 

 

 

 

 

(6,550

)

Issuance of Perceptive derivative liability

 

 

 

 

 

 

 

 

 

 

 

235

 

 

 

235

 

Change in estimated fair value

 

 

(1,672

)

 

 

4,765

 

 

 

(2,534

)

 

 

 

 

 

559

 

Balance as of June 30, 2018

 

$

-

 

 

$

16,800

 

 

$

 

 

$

235

 

 

$

17,035

 

 

13


 

The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period.  There were no transfers between Level 1, Level 2 and Level 3 categories during the periods presented.

In determining fair value, the Company uses various valuation approaches within the fair value measurement framework.  The valuation methodologies used for the Company’s instruments measured at fair value and their classification in the valuation hierarchy are summarized below:

 

Money market funds - Investments in money market funds are classified within Level 1.  At June 30, 2018 and December 31, 2017, money market funds were included on the balance sheets in cash and cash equivalents.

 

Perceptive Credit Agreement - The Company has recorded its debt with Perceptive at carrying value.  The fair value is consistent with its carry value of $13.3 million as of June 30, 2018.

 

Contingent consideration liability - As of December 31, 2017, the Company had a contingent obligation to issue 227,845 shares of the Company’s common stock to the former owners of IMX in conjunction with its acquisition of IMX in June 2014. The shares were issuable upon the Company completing 2,500 commercial tests involving the measurement of dd-cfDNA in organ transplant recipients in the United States by June 10, 2020.  The fair value of the contingent consideration is estimated using the closing market price of the common stock multiplied by management’s estimate of the probability of achievement of the contingency condition disclosed above, as of each period end.  The probability of achievement of a contingency condition was a significant input in the Level 3 measurement and was 100% in presented periods. Increases (decreases) in the estimation of the probability percentage resulted in a directionally similar impact to the fair value of the contingent consideration liability.  The Company achieved the contingent consideration milestone of 2,500 commercial tests and issued the 227,845 shares in the three months ended June 30, 2018.  There is no contingent consideration outstanding at June 30, 2018.

 

Common stock warrant liability – The Company utilizes a binomial-lattice pricing model (the “Monte Carlo Simulation Model”) that involves a market condition simulation to estimate the fair value of the warrants.  The application of the Monte Carlo Simulation Model requires the use of a number of complex assumptions including the Company’s stock price, expected life of the warrants, stock price volatility determined from the Company’s historical stock prices and stock prices of peer companies in the diagnostics industry, and risk-free rates based on the implied yield currently available in the U.S. Treasury zero-coupon issues with a remaining term equal to the expected life of the warrants.  Increases (decreases) in the assumptions discussed above result in a directionally similar impact to the fair value of the common stock warrant liability.  

 

JGB Debt derivative liability – The Company utilized the Monte Carlo Simulation Model to estimate the fair value of the compound derivative liability recorded in connection with the JGB Debt.  The Monte Carlo Simulation Model used multiple input assumptions to simulate the likelihood that market conditions will be achieved through 100,000 random trials. These assumptions included the expected term of the embedded derivative, the volatility of the Company’s stock prices and its peers’ stock prices over such expected term, likelihood, timing, and amount of future equity financing rounds, the likelihood of any prepayment or default events, the likelihood of monthly redemptions by the JGB Debt holders, and the likelihood and ability of JGB to convert the debt into equity.  In each iteration of the simulations these assumptions were used to simulate the Company’s stock price drawing from a risk neutral distribution, the occurrence of a conversion event, the occurrence of a prepayment event, the occurrence of a default event, and any resulting payoff from such event. The average present value over all iterations of the simulation was then calculated.  Increases (decreases) in the assumptions discussed above result in a directionally similar impact to the fair value of the derivative liability.  The assumptions used in this simulation model were reviewed on a quarterly basis and adjusted, as needed.  For the six months ended June 30, 2017 and from January 1, 2018 to March 27, 2018, the Company recorded the changes in fair value of the derivative liability of $1.3 million income and of $2.5 million income, respectively, in the change in estimated value of common stock warrant liability and derivative liability in its condensed consolidated statements of operations.  The derivative liability was re-measured and fully extinguished upon the final JGB Debt conversion on March 27, 2018 (see Note 10).     

 

Perceptive Credit Agreement derivative liability – The Company used a net present value analysis to estimate the fair value of the embedded derivative liability recorded in connection with the Perceptive Credit Agreement.  The assumptions used in the analysis were the discount rate, the probability of early repayment during the term of the Credit Agreement and the expected term of the derivative.  An increase in the discount rate will result in a decrease in liability and an increase in the probability of early repayment will result in an increase in liability. The assumptions used in this analysis will be reviewed on a quarterly basis and adjusted, as needed. For the three months ended June 30, 2018, the Company recorded the changes in fair value of the derivative liability of less than $0.1 million income in the change in estimated value of common stock warrant liability and derivative liability in its condensed consolidated statements of operations.

14


 

Common Stock Warrant Liability and Derivative Liability Valuation Assumptions

 

 

 

June 30, 2018

 

 

 

December 31, 2017

 

 

Private Placement Common Stock Warrant Liability

 

 

 

 

 

 

 

 

 

 

Stock Price

 

$

12.24

 

 

 

$

7.34

 

 

Exercise Price

 

$

1.12

 

 

 

$

1.12

 

 

Remaining term (in years)

 

 

4.79

 

 

 

 

5.29

 

 

Volatility

 

 

75.00

 

%

 

 

66.00

 

%

Risk-free interest rate

 

 

2.68

 

%

 

 

2.21

 

%

Subsequent Financing Common Stock Warrant Liability

 

 

 

 

 

 

 

 

 

 

Stock Price

 

$

12.24

 

 

 

$

7.34

 

 

Exercise Price

 

$

4.00

 

 

 

$

4.00

 

 

Remaining term (in years)

 

4.96

 

 

 

 

5.46

 

 

Volatility

 

 

75.00

 

%

 

 

65.00

 

%

Risk-free interest rate

 

 

2.69

 

%

 

 

2.21

 

%

Placement Agent Common Stock Warrant Liability

 

 

 

 

 

 

 

 

 

 

Stock Price

 

$

12.24

 

 

 

$

7.34

 

 

Exercise Price

 

$

1.12

 

 

 

$

1.12

 

 

Remaining term (in years)

 

2.79

 

 

 

 

3.29

 

 

Volatility

 

 

87.00

 

%

 

 

82.00

 

%

Risk-free interest rate

 

 

2.57

 

%

 

 

1.99

 

%

Perceptive Derivative Liability

 

 

 

 

 

 

 

 

 

 

Remaining term (in years)

 

 

4.80

 

 

 

 

 

 

Discount rate

 

 

7.50

 

%

 

 

 

%

JGB Common Stock Warrant Liability

 

 

 

 

 

 

 

 

 

 

Stock Price

 

 

 

 

 

$

7.34

 

 

Exercise Price

 

 

 

 

 

$

4.67

 

 

Remaining term (in years)

 

 

 

 

 

 

4.71

 

 

Volatility

 

 

 

%

 

 

69.00

 

%

Risk-free interest rate

 

 

 

%

 

 

1.89

 

%

JGB Derivative Liability

 

 

 

 

 

 

 

 

 

 

Stock Price

 

 

 

 

 

$

7.34

 

 

Remaining term (in years)

 

 

 

 

 

 

2.16

 

 

Volatility

 

 

 

%

 

 

69.00

 

%

Risk-free interest rate

 

 

 

%

 

 

2.14

 

%

 

 

5. BUSINESS COMBINATIONS AND ASSET ACQUISITIONS

Business Combinations

Allenex

On April 14, 2016, the Company acquired 98.3% of the outstanding common stock of Allenex, a transplant diagnostic company based in Stockholm, Sweden that developed, manufactured and sold products that help match donor organs with potential recipients prior to transplantation.  Allenex had a presence and direct distribution channels in the United States and Europe, with additional third party distributors in Europe and other markets around the world. Under the terms of the Conditional Share Purchase Agreements entered into on December 16, 2015, as amended, and the tender offer prospectus dated March 7, 2016, and as a result of the tender offer, the aggregate purchase consideration paid by the Company was approximately $34.1 million and consisted of (i) $26.9 million of cash, of which $5.7 million (which represents SEK 50,620,000 as of the acquisition date) was deferred purchase consideration originally payable to Midroc Invest AB, FastPartner AB and Xenella Holding AB, the former majority shareholders of Allenex (the “Former Majority Shareholders”) by no later than March 31, 2017, subject to certain contingencies being met, and (ii) the issuance of 1,375,029 shares of the Company’s common stock valued at $7.2 million.

Of the total cash consideration, $8.0 million of cash payable to the Former Majority Shareholders was deposited into an escrow account by the Company and subsequently invested in the Company by the Former Majority Shareholders through a purchase of the Company’s equity securities in a private placement.  Upon the completion of such private placement, certain contingencies in the Conditional Share Purchase Agreements were waived. On June 8, 2016, the Company delisted Allenex’s common stock from Nasdaq Stockholm.  

15


 

The date by which the deferred purchase consideration was due to the Former Majority Shareholders was subsequently extended to July 1, 2017.  In addition, i nterest began accruing on the Company’s obligations to the Former Majority Shareholders (th e “Deferred Obligation”) at a rate of 10.0% per year commencing on January 1, 2017.  On July 1, 2017, the Deferred Obligation totaled $6.3 million.    On July 1, 2017, the Conditional Share Purchase Agreements were amended in order to, among other things: (i ) convert approximately $1.1 million of the Deferred Obligation into 1,022,544 shares of the Company’s common stock at a per share price equal to $1.12; (ii) require that the Company make an immediate cash payment of $0.5 million thereby reducing the Defer red Obligation by $0.5 million; (iii) extend the maturity date of a portion of the obligations, totaling approximately $2.9 million, under the Conditional Share Purchase Agreements to March 31, 2019; and (iv) provide that approximately $2.1 million of the Deferred Obligation would become payable on December 31, 2017 unless converted into shares of the Company’s common stock prior to that date, which issuance of shares was subject to approval by the Company’s stockholders.  Interest began to accrue on the De ferred Obligation at a rate of 10% per annum commencing on July 1, 2017.  On November 14, 2017, the Company further amended the Conditional Share Purchase Agreements with the Former Majority Shareholders, and, as a result, the Company paid the total remain ing deferred purchase consideration of $4.7 million, plus accrued interest.  

The Company has accounted for the Allenex transaction as a business combination in exchange for total consideration of approximately $34.1 million.  Under business combination accounting, the total purchase price was allocated to Allenex’s net tangible and identifiable intangible assets based on their estimated fair values as of April 14, 2016.

The fair value of the remaining 1.7% of noncontrolling interest in Allenex was purchased on March 15, 2018.  The fair value of the noncontrolling interest was determined based on the number of outstanding shares comprising the noncontrolling interest and Allenex’s stock price of SEK 2.48 per share as of the acquisition date.  The noncontrolling interest was presented as a component of stockholders’ equity on the Company’s condensed consolidated balance sheets at December 31, 2017.

Conexio

On January 20, 2017, the Company acquired the business assets of Conexio Genomics Pty. Ltd (“Conexio”). Prior to the acquisition, the Company was the exclusive distributor of the Conexio SBT TM product line for all countries excluding Australia.  The Company purchased rights to many of the assets, such as machinery, facilities leases, know-how and the opportunity to retain key Conexio employees to continue producing and selling SBT products.  The Company paid $0.4 million in cash and will make quarterly payments of 20% of the gross revenue from the sale of SBT products up to an aggregate total of $0.7 million.  During each of the six months ended June 30, 2018, and June 30, 2017, the Company paid less than $0.1 million.  The Company accounted for this transaction as a business combination.

Asset Acquisition

Illumina License and Commercialization Agreement

On May 4, 2018, the Company entered into a License and Commercialization Agreement (the “License Agreement”) with Illumina, which provides the Company with certain worldwide distribution, development and commercialization rights to Illumina’s NGS product line for use in the field of bone marrow and solid organ transplantation diagnostic testing (the “Field”).   As a result, from June 1, 2018, the Company is the exclusive worldwide distributor of Illumina’s TruSight HLA v1 and v2 product line. In addition, the Company was also granted the exclusive right to develop and commercialize other NGS product lines for use in the Field.

The License Agreement required the Company to make a $5.0 million initial cash payment to Illumina and further requires the Company to pay royalties in the mid-single to low-double digits on sales of future commercialized products. Pursuant to the License Agreement, the Company is obligated to complete timely development and commercialization of other NGS product lines for use in the Field, and has agreed to minimum purchase commitments of finished products and raw materials from Illumina through 2023.

As the License Agreement did not meet the definition of a business combination under FASB ASC Topic 805, Business Combinations, the Company accounted for the transaction as an asset acquisition. In an asset acquisition goodwill is not recognized, but rather any excess consideration transferred over the fair value of the net assets acquired is allocated on a relative fair value basis to the identifiable assets acquired.

Costs relating to the assets acquired were $5.2 million, comprising of the cash consideration of $5.0 million and associated transaction costs of $0.2 million. A deferred tax balance was not required to be established on the License Agreement date as the book and tax basis of the intangible assets was equivalent to the amount paid.

The allocation of the purchase price to identified intangible assets acquired was based on the Company's best estimate of the fair value of such assets as of the acquisition date. Significant assumptions utilized in the valuation of identified intangible assets were based on company specific information and projections, which are not observable in the market and are thus considered Level 3 measurements

16


 

as defined by U.S. GAAP. The Company determined the estimated fair values using Level 3 inputs after review and consideration of relevant information, including discounted cash flows, quoted market prices and estimates made by management.

Customer relationships represent the fair value of future projected revenue that is expected to be derived from sales of TruSight HLA products to existing customers of Illumina. The customer contracts and related relationships value has been estimated utilizing a multi-period excess earnings method under income approach, which reflects the present value of the projected cash flows that are expected to be generated by the customer relationships less charges representing the contribution of other assets to those cash flows that use projected cash flows with and without the intangible asset in place. The economic useful life was determined based on the life of the products, assuming that the existing customers will remain with the Company until the products becomes obsolete. The Company utilized a discount rate of 18% in estimating the fair value of the customer relationships.

The acquired in-process technology represents the fair value of products in development that have not reached commercial production at the date of acquisition. The fair value of the products was also determined using the multi-period excess earnings method under income approach. A rate of 30% and 40% for the AlloSeq HLA acquired in-process technology and the AlloSeq BMT acquired in-process technology, respectively, was utilized to discount the cash flows to the present value. The acquired in-process technology will not be amortized until completion of the related products, which is determined by when the products commence commercial production. Upon completion, each acquired in-process technology product will be amortized over its estimated useful life.

 

The following table summarizes the fair values of the intangible assets acquired as of the closing date (in thousands):

 

 

Estimated Fair Value

 

 

Estimated Useful Lives (Years)

 

Customer relationships: TruSight HLA

 

$

380

 

 

2.6

 

Acquired in-process technology: AlloSeq HLA

 

 

2,719

 

 

 

 

Acquired in-process technology: AlloSeq BMT

 

 

2,103

 

 

 

 

Total

 

$

5,202

 

 

 

 

 

 

 

6. GOODWILL AND INTANGIBLE ASSETS

Goodwill

Goodwill is recorded when the purchase price of an acquisition exceeds the fair value of the net tangible and identified intangible assets acquired.  The Company reported $12.0 million of goodwill on the condensed consolidated balance sheet as of each of June 30, 2018 and December 31, 2017.

Goodwill is tested annually for impairment at the reporting unit level during the fourth quarter or earlier upon the occurrence of certain events or substantive changes in circumstances.  On January 1, 2017, the Company adopted ASU 2017-04, which eliminated the Step 2 requirement of the goodwill impairment test. Instead, the goodwill impairment test is performed by comparing the fair value of a reporting unit with its carrying amount.  The Company determined that the decrease in its market capitalization in the first quarter of 2017 constituted an indicator of impairment and therefore a goodwill impairment test was completed as of March 31, 2017.  The goodwill impairment test determined that the fair value of the Pre-Transplant reporting unit was $3.5 million, which was lower than its carrying value.  Accordingly, the Company recorded a goodwill impairment charge of $2.0 million as of March 31, 2017, which represented the remaining goodwill balance in the Pre-Transplant reporting unit.  The significant assumptions utilized in the March 31, 2017 discounted cash flow analysis for the Pre-Transplant reporting unit were a discount rate of 16.6%, a terminal growth rate of 3.2% and a capitalization multiple of 7.48.  

There were no indicators of impairment in the three and six months ended June 30, 2018.

17


 

Intangible Assets

The following tables present details of the Company’s intangible assets as of June 30, 2018 (in thousands):

 

 

June 30, 2018

 

 

 

Gross

Carrying

Amount

 

 

Accumulated

Amortization

 

 

Foreign

Currency

Translation

 

 

Net   Carrying

Amount

 

 

Remaining

Useful   Life

(In   Years)

 

Intangible assets with finite lives:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customer relationships: Allenex

 

$

12,650

 

 

$

(1,810

)

 

$

(1,117

)

 

$

9,723

 

 

 

12.5

 

Customer relationships: Conexio

 

 

28

 

 

 

(5

)

 

 

(1

)

 

 

22

 

 

 

7.6

 

Customer relationships: TruSight HLA

 

 

380

 

 

 

(12

)

 

 

 

 

 

368

 

 

 

2.5

 

Developed technology: Olerup SSP

 

 

11,650

 

 

 

(2,524

)

 

 

(987

)

 

 

8,139

 

 

 

7.5

 

Acquired technology: Olerup QTYPE

 

 

4,510

 

 

 

(528

)

 

 

(402

)

 

 

3,580

 

 

 

12.5

 

Acquired technology: Olerup SBT

 

 

127

 

 

 

(21

)

 

 

(6

)

 

 

100

 

 

 

7.6

 

Acquired technology: dd-cfDNA

 

 

6,650

 

 

 

(381

)

 

 

 

 

 

6,269

 

 

 

12.3

 

Trademarks

 

 

2,260

 

 

 

(384

)

 

 

(139

)

 

 

1,737

 

 

 

12.5

 

Total intangible assets with finite lives

 

$

38,255

 

 

$

(5,665

)

 

$

(2,652

)

 

$

29,938

 

 

 

 

 

Acquired in-process technology: AlloSeq HLA

 

 

2,719

 

 

 

 

 

 

 

 

 

2,719

 

 

 

 

Acquired in-process technology: AlloSeq BMT

 

 

2,103

 

 

 

 

 

 

 

 

 

2,103

 

 

 

 

Total intangible assets

 

$

43,077

 

 

$

(5,665

)

 

$

(2,652

)

 

$

34,760

 

 

 

 

 

 

The following tables present details of the Company’s intangible assets as of December 31, 2017 (in thousands):

 

 

December 31, 2017

 

 

 

Gross

Carrying

Amount

 

 

Accumulated

Amortization

 

 

Foreign

Currency

Translation

 

 

Net   Carrying

Amount

 

 

Remaining

Useful   Life

(In   Years)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Customer relationships: Allenex

 

$

12,650

 

 

$

(1,394

)

 

$

(250

)

 

$

11,006

 

 

 

13.0

 

Customer relationships: Conexio

 

 

28

 

 

 

(3

)

 

 

1

 

 

 

26

 

 

 

8.1

 

Developed technology: Olerup SSP

 

 

11,650

 

 

 

(1,942

)

 

 

(258

)

 

 

9,450

 

 

 

8.0

 

Acquired technology: Olerup QTYPE

 

 

4,510

 

 

 

(376

)

 

 

(84

)

 

 

4,050

 

 

 

13.0

 

Acquired technology: Olerup SBT

 

 

127

 

 

 

(14

)

 

 

5

 

 

 

118

 

 

 

8.1

 

Acquired technology: dd-cfDNA

 

 

6,650

 

 

 

(127

)

 

 

 

 

 

6,523

 

 

 

12.9

 

Trademarks

 

 

2,260

 

 

 

(310

)

 

 

16

 

 

 

1,966

 

 

 

13.0

 

Total intangible assets

 

$

37,875

 

 

$

(4,166

)

 

$

(570

)

 

$

33,139

 

 

 

 

 

Amortization expense was $0.6 million and $0.6 million for the three months ended June 30, 2018 and 2017, respectively.  For the three months ended June 30, 2018, expenses of $0.4 million and $0.2 million were amortized to cost of product and sales and marketing expense, respectively.  For the three months ended June 30, 2017, expenses of $0.4 million and $0.2 million were amortized to cost of product and sales and marketing expense, respectively.  Amortization expense was $1.2 million for each of the six months ended June 30, 2018 and 2017. For the six months ended June 30, 2018, expenses of $0.7 million and $0.5 million were amortized to cost of product and sales and marketing, expense, respectively.  For the six months ended June 30, 2017, expenses of $0.7 million and $0.5 million were amortized to cost of product and sales and marketing expense, respectively.  

18


 

The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of June 30, 2018 (in thousands):

 

Years Ending December 31,

 

Cost of

Product

 

 

Sales and

Marketing

 

 

Total

 

Remainder of 2018

 

$

949

 

 

$

533

 

 

$

1,482

 

2019

 

 

1,893

 

 

 

1,067

 

 

 

2,960

 

2020

 

 

1,893

 

 

 

1,067

 

 

 

2,960

 

2021

 

 

1,893

 

 

 

920

 

 

 

2,813

 

2022

 

 

1,893

 

 

 

920

 

 

 

2,813

 

2023

 

 

1,893

 

 

 

920

 

 

 

2,813

 

Thereafter

 

 

7,673

 

 

 

6,424

 

 

 

14,097

 

Total future amortization expense

 

$

18,087

 

 

$

11,851

 

 

$

29,938

 

 

The Company evaluates the carrying value of the intangible assets, not subject to amortization, related to in‑process research and development (“IPR&D”) assets, which are considered to be indefinite‑lived until the completion or abandonment of the associated research and development efforts. Accordingly, amortization of the IPR&D assets will not occur until the products reach commercialization. During the period the assets are considered indefinite‑lived, they are tested for impairment on an annual basis, as well as between annual tests if the Company becomes aware of any events occurring or changes in circumstances that would indicate that the fair values of the IPR&D assets are less than their carrying amounts. An impairment loss would be recorded when the fair value of an IPR&D asset is less than its carrying value. If and when development is complete, which generally occurs when the products are made commercially available, the associated IPR&D asset will be deemed definite‑lived and will then be amortized based on its estimated useful life.

 

 

7. BALANCE SHEET COMPONENTS

Inventory

Inventory consisted of the following (in thousands):

 

 

 

 

 

 

 

 

 

 

 

June 30,

2018

 

 

December 31,

2017

 

Finished goods

 

$

1,379

 

 

$

2,569

 

Work in progress

 

 

1,548

 

 

 

1,471

 

Raw materials

 

 

1,739

 

 

 

1,489

 

Total inventory

 

$

4,666

 

 

$

5,529

 

 

Accrued and other liabilities

Accrued and other liabilities consisted of the following (in thousands):

 

 

 

June 30,

2018

 

 

December   31,

2017

 

Clinical studies

 

$

1,580

 

 

$

1,115

 

Test sample processing fees

 

 

614

 

 

 

633

 

Shares withheld in lieu of taxes

 

 

557

 

 

 

 

Deferred rent – current portion

 

 

419

 

 

 

419

 

Professional fees

 

 

398

 

 

 

475

 

Customer overpayments and refunds due

 

 

259

 

 

 

270

 

Capital leases – current portion

 

 

139

 

 

 

13

 

Accrued royalty

 

 

159

 

 

 

 

Software implementation costs

 

 

50

 

 

 

94

 

Accrued interest payable

 

 

37

 

 

 

81

 

Other accrued expenses

 

 

491

 

 

 

635

 

Total accrued and other liabilities

 

$

4,703

 

 

$

3,735

 

 

 

19


 

8. COMMITMENTS AND CONTINGENCIES

Leases

The Company leases its operating and office facilities for various terms under long-term, non-cancelable operating lease agreements in Brisbane, California; West Chester, Pennsylvania; Fremantle, Australia; and Stockholm, Sweden.  The lease for the Company’s facility in Vienna, Austria is on a month-to-month basis. The facility leases expire at various dates through 2020.  In the normal course of business, it is expected that these leases will be renewed or replaced by leases on other properties.

Rent expense under the non-cancelable operating leases was $0.4 million for each of the three months ended June 30, 2018 and 2017. Rent expense under the non-cancelable operating leases was $0.9 million for each of the six months ended June 30, 2018 and 2017. Future minimum lease commitments under these operating and capital leases on June 30, 2018, are as follows (in thousands):

 

Years Ending December 31,

 

Capital

Leases

 

 

Operating

Leases

 

Remainder of 2018

 

$

85

 

 

$

1,111

 

2019

 

 

162

 

 

 

2,133

 

2020

 

 

157

 

 

 

2,046

 

2021

 

 

45

 

 

 

10

 

2022

 

 

 

 

 

7

 

Total future minimum lease payments

 

$

449

 

 

$

5,307

 

 

The current portion of obligations under capital leases is included in accrued and other liabilities on the balance sheets.  The long-term portion is included in other liabilities on the balance sheets.

Royalty Commitments

Roche Molecular Systems, Inc. (“Roche”)

In November 2004, the Company entered into a license agreement with Roche pursuant to which Roche granted the Company the right to use certain Roche technology relating to PCR, and quantitative real-time PCR in clinical laboratory services, including in connection with AlloMap.  This is a non-exclusive license agreement in the United States covering claims in multiple Roche patents.

Under the license agreement, the Company incurred royalty expenses as a percentage of combination services revenue and classifies those expenses as a component of cost of testing in the condensed consolidated statements of operations.  Royalty expenses in connection with the Roche agreement were $0.3 million and $0.6 million for the three and six months ended June 30, 2017, respectively.  Effective September 30, 2017, no future royalties are payable by the Company under the Roche agreement.

The Board of Trustees of the Leland Stanford Junior University (“Stanford”)

In June 2014, the Company entered into a license agreement with Stanford, or the Stanford License, which granted the Company an exclusive license to a patent relating to the diagnosis of rejection in organ transplant recipients using dd-cfDNA. Under the terms of the Stanford License, the Company is required to pay an annual license maintenance fee, six milestone payment amounts and royalties in the low single digits of net sales of products incorporating the licensed technology. The license maintenance fee may be offset against earned royalty payments due on net sales in that year.

Commercial sales of AlloSure, which incorporates the licensed technology from Stanford, began in October 2017. In each of the three and six months ended June 30, 2018, the Company incurred royalties of $0.2 million to Stanford.

Conexio

On January 20, 2017, the Company acquired the business assets of Conexio, which included machinery, facilities leases, know-how and the opportunity to retain key Conexio employees to continue producing and selling the SBT line of products. The Company makes quarterly payments to Conexio of 20% of the gross revenue from the sale of the SBT products using the purchased assets up to an aggregate total of $0.7 million.  During the three months ended June 30, 2018 and June 30, 2017, the Company paid less than $0.1 million and nil, respectively.  During each of the six months ended June 30, 2018 and June 30, 2017, the Company paid less than $0.1 million.    

20


 

Illumina

On May 4, 2018, the Company entered into the License Agreement with Illumina. The License Agreement requires the Company to pay royalties in the mid-single to low-double digits on sales of future commercialized products. In the three months ended June 30, 2018, the Company paid no royalties to Illumina.

Other Commitments

Pursuant to the License Agreement with Illumina, the Company is obligated to complete timely development and commercialization of other NGS product line for use in the Field, and has agreed to minimum purchase commitments of finished products and raw materials from Illumina through 2023.

Litigation

From time to time, the Company may become involved in litigation and other legal actions. The Company estimates the range of liability related to any pending litigation where the amount and range of loss can be estimated. The Company records its best estimate of a loss when the loss is considered probable. Where a liability is probable and there is a range of estimated loss with no best estimate in the range, the Company records a charge equal to at least the minimum estimated liability for a loss contingency when both of the following conditions are met: (i) information available prior to issuance of the financial statements indicates that it is probable that a liability had been incurred at the date of the financial statements and (ii) the range of loss can be reasonably estimated.

In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for indemnification for certain liabilities. The exposure under these agreements is unknown because it involves claims that may be made against the Company in the future but have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations. The Company also has indemnification obligations to its directors and executive officers for specified events or occurrences, subject to some limits, while they are serving at the Company’s request in such capacities. There have been no claims to date and the Company believes the fair value of these indemnification agreements is minimal. Accordingly, the Company has not recorded any liabilities for these agreements as of June 30, 2018 and as of December 31, 2017.

 

 

9. LICENSE AND OTHER REVENUE

Diaxonhit

In June 2013, the Company entered into an exclusive Distribution and Licensing Agreement with Diaxonhit, SA (“Diaxonhit”) a French public company, whereby Diaxonhit agreed to have the AlloMap test performed in a European laboratory and commercialize the test in the European Economic Area (“EEA”).  The agreement will expire at the later of the last-to-expire patent in the EEA or ten years from the first commercial sale of the test in the EEA, which occurred in 2014.

Consideration under the agreement included an upfront cash payment of approximately €387,500 ($408,000) that is designated to offset royalties earned by the Company.  The Company is entitled to receive royalties from Diaxonhit as a percentage of net sales, as defined in the agreement, of AlloMap tests in the mid to high teens. Upon confirmation that the CE mark was in place, the Company also received an equity payment of Diaxonhit common stock with a value of €387,500 ($476,000). The Company sold the shares of common stock in July 2013 for total consideration of $467,000.  The CE mark is a mandatory conformity marking for certain products sold within the EEA.

Other performance obligations for which the Company may recognize revenue includes agreed-upon per unit pricing for the supply of AlloMap products, and additional royalties that are payable upon the achievement of various sales milestones by Diaxonhit. Commercial sales of the AlloMap test began in the EEA in June 2014.  Total revenues and royalties recognized from this arrangement for each of the three months ended June 30, 2018 and 2017 were $10,000.  Total revenue and royalties recognized from this arrangement for each of the six months ended June 30, 2018 and 2017 were $19,000.

CardioDx, Inc.

In 2005, the Company entered into a services agreement with what at the time was a related party, CardioDx, Inc. (“CDX”), whereby the Company provided CDX with biological samples and related data and performed laboratory services on behalf of CDX.  Each company granted the other a worldwide license to certain of its intellectual property rights.  Pursuant to this agreement, CDX pays royalties to the Company in an amount equal to a low single-digit percentage of the cash collected from sales of CDX licensed products. The royalty obligation to the Company continues until 2019.  The Company recognizes royalty revenues when payments are received as it was assessed that collection was not able to be estimated. Royalty revenues for each of the three months ended June 30, 2018 and 2017 were $0.2 million.  Royalty revenues for the six months ended June 30, 2018 and 2017 were $0.3 million and $0.2

21


 

million, respectively.  Royalty revenues are included in license revenue on the condensed consolidated statements of oper ations.  The Company had no receivable balance from CDX as of June 30, 2018 and December 31, 2017.  

 

 

10. DEBT

Debt consisted of the following (in thousands):

 

 

June 30, 2018

 

 

December   31,   2017

 

JGB Debt

 

$

 

 

$

7,743

 

Danske Bank Credit Facility

 

 

 

 

 

6,763

 

SSP Primers Loan

 

 

 

 

 

1,215

 

Current portion of long-term debt

 

$

 

 

$

15,721

 

 

 

 

 

 

 

 

 

 

Perceptive Credit Agreement

 

$

13,337

 

 

$

 

JGB Debt

 

 

 

 

 

14,168

 

Danske Bank Term Loan

 

 

 

 

 

 

FastPartner Subordinated Promissory Notes

 

 

 

 

 

2,400

 

Al Amoudi Subordinated Promissory Notes

 

 

 

 

 

1,770

 

Long-term debt, net of current portion

 

$

13,337

 

 

$

18,338

 

Unamortized debt discount and issuance costs as of June 30, 2018 and December 31, 2017 were $1.7 million and $4.6 million, respectively.  Total interest accrued on debt as of June 30, 2018 and December 31, 2017 was nil and $0.3 million, respectively.  The current accrued interest balance of $0.1 million and long-term accrued interest balance of $0.2 million as of December 31, 2017, were recorded in accrued and other liabilities and in other liabilities long-term, respectively, in the condensed consolidated balance sheets.

As of June 30, 2018, future debt maturities were as follows (in thousands):

 

Years Ending December 31,

 

Amount

 

2021

 

$

2,025

 

2022

 

 

2,700

 

2023

 

 

10,275

 

Total debt maturities

 

 

15,000

 

Less: debt discount and issuance costs

 

 

(1,663

)

Long-term debt, net carrying value

 

 

13,337

 

Perceptive Credit Agreement

On April 17, 2018, the Company entered into a credit agreement with Perceptive for an initial term loan of $15.0 million (“Tranche A Term Loan”) with a second tranche of $10.0 million available at the Company’s option, subject to the satisfaction of customary conditions (the “Tranche B Term Loan” and, together with the “Tranche A Term Loan”, the “Term Loam”).  Approximately $11.1 million of the proceeds of the Tranche A Term Loan were used to fully repay the Company’s outstanding indebtedness, including accrued interest, with FastPartner AB, Mohammed Al Amoudi and Danske on April 17, 2018 . The remainder of the proceeds will be used for general corporate purposes.

In connection with the Perceptive Credit Agreement, the Company entered into a Security Agreement with Perceptive, as administrative agent. The Security Agreement provides that the Term Loan is secured by substantially all of the Company’s assets and a pledge of 65% of the equity interests of CareDx International AB.  The Term Loan accrues interest per annum at 9.00% (the “Applicable Margin”) plus the greater of the one-month LIBOR or 1.5%.  Payments under the Perceptive Credit Agreement are interest-only until the first principal payment is due on April 30, 2021, followed by monthly payments of principal and interest through the scheduled maturity date on April 17, 2023. The Term Loan may be prepaid by the Company, in whole or in part at any time, subject to a prepayment fee.  

The Company paid a fee of $0.3 million to Perceptive in its capacity as the administrative agent under the Security Agreement. In addition, on April 17, 2018, the Company issued to Perceptive the Perceptive Tranche A Warrant to purchase up to 140,000 shares of common stock of the Company at an initial exercise price of $8.60. The Perceptive Tranche A Warrant will be exercisable commencing on October 17, 2018 and will terminate, if not earlier exercised, on April 17, 2025.

The Tranche B Term Loan is available at the Company’s option at any time from April 17, 2018 to April 17, 2019, subject to the Company achieving certain product revenue targets and satisfying customary conditions. In the event the Company exercises its

22


 

option for the Tranche B Term Loan, the Company will pay to Perceptive as the administrative agent out of the proceeds of the Tranche B Term Loan a fee in the amount equal to 1.75% of the principal amount of the Tranche B Term Loan advanced on such date. If the Tranche B Term Loan is funded, the Company will issue to Perceptive an additional warrant (the “Tranche B Warrant”), to purchase up to 93,333 shares of common stock at an initial exercise price of $8.60 and with other terms consistent with the Tranche A Warrant.

 

The Perceptive Credit Agreement contains financial covenants related to minimum cash balance and trailing twelve month revenue. As of June 30, 2018, the Company was in compliance with the financial covenants.

The Perceptive Credit Agreement provides for customary events of default, including, among other things, nonpayments of principal, interest and other amounts, inaccuracies in representations and warranties, failure to comply with covenants, defaults on other material indebtedness, bankruptcy or insolvency, judgments, changes of control or impairments of Perceptive’s security interests. Upon the occurrence of an event of default and following any applicable cure periods, if any, the Applicable Margin shall automatically increase 3.00% per annum (the “Default Rate”). This Default Rate may be applied to the outstanding loan balances, and the Agent may declare all outstanding obligations immediately due and payable and take such other actions as set forth in the Perceptive Credit Agreement .  The Company concluded that the early repayment provisions were an embedded derivative liability requiring bifurcation. This embedded derivative liability will be re-measured at each reporting period and the change in fair value will be recognized in the consolidated statement of operations.

The following table summarizes the Company’s carrying value of the Perceptive Security Agreement (in thousands) on April 17, 2018, the issuance date (in thousands):

 

 

April 17, 2018

 

Debt principal

 

$

15,000

 

Less:

 

 

 

 

          Issuance cost

 

 

(669

)

          Discount related to issued warrants

 

 

(784

)

          Embedded derivative liability

 

 

(245

)

Total debt discount

 

 

(1,698

)

Carrying value

 

$

13,302

 

JGB Debt

On March 15, 2017, the Company entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with JGB pursuant to which the Company issued to JGB debentures (the “Debentures”) with an aggregate principal amount of $27.8 million and warrants to purchase shares of the Company’s common stock (the “JGB Warrants”) for net proceeds of $24.0 million (the “Financing”).  The Company used $11.2 million of the net proceeds from the Financing to repay its existing indebtedness under the Loan Agreement with East West Bank and was required to maintain restricted cash of $9.4 million.

Under the Securities Purchase Agreement, the Debentures would have matured on February 28, 2020, accrued interest at 9.5% per year and were convertible into an aggregate of approximately 6,092,105 shares of the Company’s common stock at a price of $4.56 per share (the “Conversion Price”), subject to adjustment for accrued and unpaid interest and upon the occurrence of certain transactions, at the holder’s option.

Additionally, after September 1, 2017, upon the satisfaction of certain conditions, including the volume weighted average price of the Company’s common stock exceeding 250% of the Conversion Price for twenty consecutive trading days, the Company could have required that the Debentures be converted into shares of the Company’s common stock, subject to certain limitations. Commencing on March 1, 2018, each of the holders of the Debentures had the right, at its option, to require the Company to redeem up to $937,500 of the outstanding principal amount of its Debenture per month.  The Company was required to promptly, but in any event no more than one trading day after the holder delivers a redemption notice to the Company, pay the applicable redemption amount in cash or, at the Company’s election and subject to certain conditions, in shares of the Company’s common stock.  If the Company elected to pay the redemption amount in shares of the Company’s common stock, then the shares would have been delivered based on a price equal to the lowest of (a) 88% of the average of the three lowest volume weighted average prices of the Company’s common stock over the prior 20 trading days, (b) 88% of the prior trading day’s volume weighted average price, or (c) the Conversion Price.

After either a change of control transaction, as defined in the Debentures, or February 28, 2018, subject to the satisfaction of certain conditions, the Company could have redeemed all of the then outstanding principal amount of the Debentures for cash by paying the outstanding principal balance, accrued and unpaid interest, and a payment premium.  The payment premium would have been calculated by multiplying the outstanding balance and the following percentage: (i) 15% if the Debentures were prepaid on or prior to

23


 

March 1, 2018, (ii) 8% if the Debentures were prepaid after March 1, 2018 but prior to March 1, 2019, and (iii) 5% if the Debentures were prepaid on or after March 1, 2019.

The Company’s obligations under the Debentures could have been accelerated upon the occurrence of certain events of default as specified in the agreement.  In the event of default and acceleration of the Company’s obligations, the Company would have been required to pay (i) 115% of all amounts of principal and interest then outstanding under the Debentures in cash if the Debentures were accelerated prior to March 1, 2018, (ii) 108% of all amounts of principal and interest then outstanding under the Debentures in cash if the Debentures were accelerated after March 1, 2018, but prior to March 1, 2019, and (iii) 105% of all amounts of principal and interest then outstanding under the Debentures in cash if the Debentures were accelerated after March 1, 2019.  The Company’s obligations under the Debentures were secured under a Security Agreement by a senior lien on all of the Company’s assets, other than its interest in CareDx International AB (formerly known as Allenex AB), which was subject to a negative pledge prohibiting the incurrence of additional or replacement debt.

The Debentures contained customary affirmative and restrictive covenants and representations and warranties, including financial reporting obligations, a restriction on the Company’s ability to pay cash dividends on its common stock and limitations on indebtedness, liens, investments, distributions, transfers, corporate changes, deposit accounts and subsidiaries.  The Company was also required to maintain a minimum cash amount at all times, achieve commercialization of AlloSure by a certain date and achieve certain gross profit targets for sales of its AlloMap product.

In connection with the Financing, on March 15, 2017, the Company and the Purchasers entered into a Registration Rights Agreement (the “Registration Rights Agreement”) pursuant to which, among other things, the Company agreed to prepare and file one or more registration statements with the SEC for the purpose of registering for resale any shares of Common Stock that may be issued by the Company upon the conversion or redemption of the Debentures or the exercise of the JGB Warrants.

The Debentures included certain embedded derivatives that required bifurcation, including settlement and penalty provisions.  The compound embedded derivatives were remeasured at each reporting period and the change in fair value was recognized in the consolidated statements of operations. See also Note 4, “Fair Value Measurements”.

The following table summarizes the Company’s carrying value of the JGB Debt (in thousands) on the March 15, 2017 issuance date:

 

 

 

March 15, 2017

 

Debt principal

 

$

27,780

 

Less:

 

 

 

 

          Issuance cost

 

 

(998

)

         Original issue discount

 

 

(2,780

)

         Original warrant valuation

 

 

(900

)

         Embedded Derivative Liability

 

 

(2,290

)

Total debt discount

 

 

(6,968

)

Carrying value

 

$

20,812

 

 

As a result of the issuance of 1,022,544 shares of the Company’s common stock issued at a price per share equal to $1.12 pursuant to the amendments to the Conditional Share Purchase Agreements, the conversion price of the Debentures decreased from $4.56 per share to $4.40 per share, effective July 3, 2017.

As a result of the 2017 Public Offering in accordance with the anti-dilution provisions in the Debentures, effective October 5, 2017, the conversion price of the Debentures decreased from $4.40 to $4.34 per share.  On October 5, 2017, JGB elected to convert $1.25 million of outstanding principal under the Debentures into shares of common stock. Accordingly, the Company issued 288,022 shares of common stock to JGB at a price per share of $4.34.  As a result of the sale of the 651,240 shares of common stock pursuant to the underwriters’ full exercise of their option to purchase additional shares in accordance with the anti-dilution provisions in the Debentures, effective October 10, 2017, the conversion price of the Debentures were decreased from $4.34 per share to $4.33 per share.  As of December 31, 2017, the JGB Debt had an outstanding principal balance of $26.5 million.

On March 1, 2018, the Company notified JGB of its intent to prepay on April 13, 2018 in full the outstanding principal and interest under the Debentures. Pursuant to the terms of the Debentures, on April 13, 2018, the Company would have been obligated to pay the full amount of the outstanding principal balance of the Debentures, plus accrued and unpaid interest thereon and a prepayment premium equal to 8% of the outstanding principal balance in cash.  In February and March 31, 2018, JGB converted the remaining $26.7 million of principal and accrued interest of the JGB Debt into an aggregate of 6,161,331 shares of the Company’s common

24


 

stock.  In connection with these conversions in the three months ended March 31, 2018, the Company recognized $6,000 to common stock and $38.8 million to additional paid in capital; the unamortized debt discount of $2.7 million was extinguished; and the compound derivative liability of $12.1 million was also extinguished.  The JGB Debt conversion resulted in a $2.8 million loss on debt extinguishment that was included in other expense, net in the condensed consolidated statements of operations.

Danske Bank Term Loan and Credit Facility

On June 25, 2013, Allenex entered into a term loan facility (the “Term Loan Facility”) with Danske in an aggregate principal amount of up to SEK 71,000,000 (approximately $8.8 million).  The Term Loan Facility was available for utilization in advances of a minimum of SEK 5,000,000 (approximately $0.6 million) and if more, integral multiples of SEK 1,000,000 (approximately $0.1 million).  The interest rate applicable to each advance was the percentage rate per annum calculated as the aggregate of (i) Stockholm Interbank Offered Rate (“STIBOR”) (as defined in the Term Loan Facility) and (ii) the Margin (as described in the Term Loan Facility) at 3% conditional on the fulfillment of certain criteria.  In March 2015, Allenex entered into a first amendment to the Term Loan Facility, pursuant to which additional loans were granted.  In August 2015, Allenex entered into a second amendment to the Term Loan Facility, pursuant to which the term of the Term Loan Facility was extended.  In December 2015, Allenex entered into a waiver and amendment agreement relating to the Term Loan Facility, pursuant to which the change of control provision was waived and amended.  In March 2016, Allenex entered into another amendment to the Term Loan Facility, which modified the repayment schedule for advances under the Term Loan Facility. Under this Term Loan Facility, SEK 47,000,000 (approximately $5.6 million) was outstanding as of March 31, 2018 and was due on June 30, 2018.  This was classified as a current debt as of March 31, 2018.

On June 18, 2015, Allenex also entered into a short term credit facility (“Credit Facility”) with Danske with total available credit of SEK 8,000,000 (approximately $1.0 million).  As of August 4, 2016, the available credit under the Credit Facility with Danske was increased to SEK 10,000,000 (approximately $1.2 million).  As of March 31, 2018, the total outstanding balance due to Danske under the Credit Facility was approximately SEK 3,850,000 (approximately $0.5 million), and was due on June 30, 2018.

A quarterly debt covenant in the Term Loan Facility with Danske was violated on March 31, 2017, June 30, 2017, and September 30, 2017.  The Company obtained a waiver for these violations.  The waiver was conditional upon, among other things, the Company making a principal repayment of SEK 6,000,000 (approximately $0.7 million) by October 31, 2017.  This amount was paid on October 31, 2017. The Company was not in compliance with certain debt covenants as of December 31, 2017 or March 31, 2018.  The Company repaid the full outstanding amount of SEK 47,000,000 (approximately $5.6 million), including accrued interest of SEK 142,000 (approximately $17,000), under the Danske Term Loan and Credit Facility on April 17, 2018.

FastPartner Subordinated Promissory Notes

On June 28, 2013, Allenex issued a SEK 9,400,000 (approximately $1.1 million) subordinated promissory note to FastPartner, which had an interest rate of 10.00%.  On December 29, 2015, Allenex issued a SEK 2,000,000 (approximately $0.2 million) subordinated promissory note to FastPartner, which had an annual interest rate of 10.00%.

On March 7, 2016, Allenex issued a SEK 4,000,000 (approximately $0.5 million) subordinated promissory note to FastPartner, which had an annual interest rate of 10.00%.  Pursuant to an intercreditor agreement, until the Term Loan Facility with Danske is repaid, FastPartner may not demand or receive payment of its subordinated promissory note, or foreclose on any collateral securing Allenex’s obligations under the subordinated promissory note, without Danske’s prior written consent. Allenex’s obligations under the promissory note are secured by a pledge of Allenex shares to FastPartner.  The full amount of the subordinated promissory note was due July 1, 2017.

On July 1, 2017, the Company entered into a note agreement with FastPartner (the “FastPartner Note Agreement”) pursuant to which, among other things, Allenex and FastPartner agreed that all amounts owed under the above subordinated promissory notes would be governed by the FastPartner Note Agreement and to defer repayment of the principal outstanding amount of SEK 15,400,000 (approximately $1.9 million) plus accrued interest of $0.5 million until March 31, 2019.  I nterest began accruing on such amount at a rate of 10% per annum, and in the event the Company makes any cash amortization repayments to JGB of the JGB Debt, or any replacement debt, Allenex will repay in cash a portion of the amount outstanding under the FastPartner Note Agreement equal to 8% of any such cash amortization repayment. As of each of March 31, 2018 and December 31, 2017, the principal outstanding amount remained at SEK 19,757,000 (approximately $2.4 million).  The Company repaid the full amount outstanding of SEK 21,300,000 (approximately $2.5 million), including accrued interest of SEK 1,600,000 (approximately $0.2 million), under the FastPartner Note Agreement on April 17, 2018.

Mohammed Al Amoudi Subordinated Promissory Note

On June 28, 2013, Allenex issued a SEK 10,600,000 (approximately $1.2 million) subordinated promissory note to Mohammed Al Amoudi, which provides for an annual interest rate of 10.00%.  Pursuant to an intercreditor agreement, until the Term Loan Facility with Danske is repaid, Mohammed Al Amoudi may not demand or receive payment of his subordinated promissory note, or foreclose

25


 

on any collateral securing Allenex’s obligations under the subordinated promissory note, without Danske’s prior written consent.  Allenex’s obligations under the promissory note are secured by a pledge of Allene x shares to Mohammed Al Amoudi.  The full amount of the subordinated promissory note was due July 1, 2017.

On July 1, 2017, the Company entered into a note agreement with Mohammed Al Amoudi (the “Al Amoudi Note Agreement”) pursuant to which, among other things, Allenex and Mohammed Al Amoudi agreed to defer repayment of the principal outstanding amount of SEK 10,600,000 (approximately $1.3 million) plus accrued interest of $0.5 million until March 31, 2019. I nterest began accruing on such amount at a rate of 10% per annum, and in the event the Company makes any cash amortization repayments to JGB of the JGB Debt, or any replacement debt, Allenex will repay in cash a portion of the amount outstanding under the Al Amoudi Note Agreement equal to 6% of any such cash amortization repayment.  As of each of March 31, 2018 and December 31, 2017, the principal outstanding amount remained at SEK 14,575,000 (approximately $1.7 million).  The Company repaid the full amount outstanding of SEK 15,700,000 (approximately $1.9 million), including accrued interest of SEK 1,200,000 (approximately $0.1 million) under the Al Amoudi Note Agreement on April 17, 2018.

Loan Agreement with SSP Primers Aktieboulag

On February 25, 2015, Allenex entered into a SEK 14,000,000 (approximately $1.7 million) loan agreement with SSP Primers Aktieboulag, pursuant to which SEK 4,000,000 (approximately $0.5 million) was paid on March 7, 2016. The loan amount outstanding as of December 31, 2017 was SEK 10,000,000 (approximately $1.2 million) plus accrued interest of SEK 650,000 (approximately $0.1 million) and was fully paid on February 26, 2018.  

 

 

11. STOCKHOLDERS’ EQUITY

2017 Public Offering

On October 10, 2017, the Company sold in the 2017 Public Offering an aggregate of 4,992,840 shares of its common stock, including 651,240 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares to cover over-allotments, at a public offering price of $4.00 per share.  

Net proceeds from the 2017 Public Offering were $18.3 million, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company.

JGB Debt

On October 5, 2017, JGB converted $1.25 million of outstanding principal under the Debentures into shares of common stock. Accordingly, the Company issued 288,022 shares of common stock to JGB at a price per share of $4.34. In the three months ended March 31, 2018, JGB converted the remaining $26.7 million of outstanding principal and accrued interest for a total issuance of 6,161,331 shares of the Company’s common stock at a price per share of $4.33.

Contingent Consideration Liability

The Company had a contingent obligation to issue 227,845 shares of the Company’s common stock to the former owners of ImmuMetrix, Inc . , or IMX, in conjunction with its acquisition of IMX in June 2014. The shares were issuable upon the Company completing 2,500 commercial tests involving the measurement of dd-cfDNA in organ transplant recipients in the United States by June 10, 2020.  The Company achieved the contingent consideration milestone of 2,500 commercial tests and issued the 227,845 shares in the period ended June 30, 2018.  

 

 

12. 401(K) PLAN

The Company sponsors a 401(k) defined contribution plan covering all U.S. employees under the Internal Revenue Code. Employee contributions are voluntary and are determined on an individual basis subject to the maximum allowable under federal tax regulations. On January 1, 2018, the Company began to make contributions to the employee plan. For each of the three and six months ended June 30, 2018, the Company incurred an expense of $0.1 million related to contributions into the plan.

 

 

13. WARRANTS

The Company issues common stock warrants in connection with debt or equity financings to a lender, a placement agent or an investor.  Issued warrants are considered standalone financial instruments and the terms of each warrant are analyzed for equity or liability classification in accordance with US GAAP. Warrants that are classified as liabilities usually have various features that would require net-cash settlement by the Company. Warrants that are not liabilities, derivatives and/or meet exception criteria are classified

26


 

as equity. Warrants liabilities are re-measured at fair valu e at each period end with changes in fair value recorded in the condensed statements of operations until expired or exercised. The Company utilizes the Monte Carlo Simulation Model to estimate the fair value of its warrants.  Refer to Note 4 for further de tails. Warrants that are classified as equity are valued at fair value on the date of issuance, recorded in additional paid in capital and not re-measured.  

On January 1, 2018, the Company adopted new accounting guidance (refer to Note 2) and reclassified the warrants to purchase 1,338,326 shares of common stock issued to JGB from liability to equity at the fair value of $6.6 million.

In the three months ended June 30, 2018, warrants to purchase 445,000 shares of common stock were exercised for a cash payment of $0.5 million.  In the six months ended June 30, 2018, warrants to purchase 468,000 shares of common stock were exercised for a cash payment of $0.5 million. The warrant liability was re-measured prior to the exercise and a change in fair value of $5.2 million and $5.4 million was recorded in the condensed consolidated statement of operations for the three and six months ended June 30, 2018, respectively.  

As of June 30, 2018, outstanding warrants to purchase common stock were:

 

 

 

Classified as

 

Original Term

 

Exercise Price

 

 

Number of Shares

Underlying

Warrants

 

Original issue date:

 

 

 

 

 

 

 

 

 

 

 

 

August 2009

 

Equity

 

10 years

 

$

21.78

 

 

 

33,473

 

July 2010

 

Equity

 

9 years

 

$

21.78

 

 

 

6,694

 

August 2012

 

Equity

 

7 years

 

$

21.78

 

 

 

167,182

 

January 2015

 

Equity

 

5 years

 

$

6.96

 

 

 

34,483

 

April 2016 (a)

 

Liability

 

7 years

 

$

1.12

 

 

 

469,124

 

April 2016 (b)

 

Liability

 

5 years

 

$

1.12

 

 

 

136,300

 

June 2016 (c)

 

Liability

 

7 years

 

$

4.00

 

 

 

1,002,507

 

March 2017 (d)

 

Equity

 

5 years

 

$

4.67

 

 

 

1,338,326

 

April 2018 (e)

 

Equity

 

7 years

 

$

8.60

 

 

 

140,000

 

April 2018 (f)

 

Equity

 

7 years

 

$

8.60

 

 

 

93,333

 

 

 

 

 

 

 

 

 

 

 

 

3,421,422

 

 

(a)

Issued on April 14, 2016 in connection with the private placement to certain accredited investors.  In accordance with the anti-dilution provisions, the exercise price of the warrants issued in connection with such private placement was adjusted from $4.98 to $4.00, which was the price paid by investors in the Company’s underwritten public offering of common stock, which closed on September 26, 2016.  As a result of the issuance of 1,022,544 shares of the Company’s common stock at $1.12 in connection with the amendments to the Conditional Share Purchase Agreement, the exercise price was adjusted from $4.00 to $1.12, effective July 3, 2017.

(b)

Issued on April 14, 2016 in connection with the private placement to placement agents.  As a result of the issuance of 1,022,544 shares of the Company’s common stock at $1.12 in connection with the amendments to the Conditional Share Purchase Agreement, the exercise price was adjusted from $3.99 to $1.12, effective July 3, 2017.  

(c)

Issued on June 15, 2016 in connection with a subsequent private placement.  In accordance with the anti-dilution provisions, the exercise price of the warrants issued in connection with the subsequent private placement was adjusted from $4.98 per share to $4.00 per share, which was the price paid by investors in the Company’s underwritten public offering of common stock, which closed on September 26, 2016.  The exercise price remained at $4.00 as the anti-dilution provision was waived for the issuance of shares related to the July 3, 2017 amendment to the Conditional Share Purchase Agreements.

(d)

Issued on March 15, 2017 in connection with the JGB Debt.  As a result of the issuance of 1,022,544 shares of the Company’s common stock at $1.12 in connection with the amendments to the Conditional Share Purchase Agreement, the number of shares issuable pursuant to the JGB Warrants increased from 1,250,000 to 1,296,679 and the exercise price of the JGB Warrants was adjusted from $5.00 to $4.82, effective July 3, 2017.  As a result of the 2017 Public Offering, effective October 5, 2017, the aggregate number of shares of common stock issuable upon exercise of the JGB Warrants increased from 1,296,679 to 1,338,326 shares and the exercise price of the JGB Warrants decreased from $4.82 to $4.67 per share.  

(e)

Issued on April 17, 2018 in connection with the Perceptive Credit Agreement.

(f)

The Perceptive Credit Agreement included a Tranche B loan amount available at the Company’s option at any time from April 17, 2018 to April 17, 2019. If the Tranche B Term Loan is funded, the Company will issue Perceptive a Tranche B Warrant to purchase up to 93,333 shares of common stock an exercise price of $8.60. The Perceptive Tranche B Warrant is considered issued for accounting purposes only and will not be exercisable unless and until legally issued in connection with a funding of the Tranche B Term Loan.

 

 

27


 

14. STOCK INCENTIVE PLANS

Stock Options and Restricted Stock Units (“RSU”)

The following table summarizes option and unvested RSU activity under the Company’s 2014 Equity Incentive Plan and 2016 Inducement Plan and related information:

 

 

 

Shares

Available

for Grant

 

 

Stock

Options

Outstanding

 

 

Weighted-

Average

Exercise

Price

 

 

Number of

RSU Shares

 

 

Weighted-

Average

Grant Date

Fair Value

 

Balance—December 31, 2017

 

 

156,429

 

 

 

1,941,473

 

 

$

4.21

 

 

 

439,926

 

 

$

4.39

 

Additional options authorized

 

 

1,957,075

 

 

 

 

 

 

 

 

 

 

 

 

 

Restricted stock grants

 

 

(17,919

)

 

 

 

 

 

 

 

 

 

 

 

 

RSUs granted

 

 

(714,834

)

 

 

 

 

 

 

 

 

714,834

 

 

 

11.63

 

RSUs forfeited

 

 

13,050

 

 

 

 

 

 

 

 

 

(13,050

)

 

 

4.87

 

RSUs vested

 

 

 

 

 

 

 

 

 

 

 

(244,806

)

 

 

9.30

 

Repurchases of common stock under employee incentive plans

 

 

67,656

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Options granted

 

 

(809,634

)

 

 

809,634

 

 

 

11.05

 

 

 

 

 

 

 

Options exercised

 

 

 

 

 

(167,379

)

 

 

1.07

 

 

 

 

 

 

 

Options forfeited

 

 

20,453

 

 

 

(20,453

)

 

 

4.78

 

 

 

 

 

 

 

Options expired

 

 

1,817

 

 

 

(1,817

)

 

 

3.55

 

 

 

 

 

 

 

Balance—June 30, 2018

 

 

674,093

 

 

 

2,561,458

 

 

$

6.57

 

 

 

896,904

 

 

$

8.83

 

 

The total intrinsic value of options exercised was $0.9 million in the six months ended June 30, 2018.

As of June 30, 2018, the total intrinsic value of outstanding RSUs was approximately $3.0 million and there were $6.6 million of unrecognized compensation costs related to RSUs, which are expected to be recognized over a weighted-average period of 3.37 years.

As of June 30, 2018, the total intrinsic value of outstanding options was approximately $13.6 million and there were $5.8 million of unrecognized compensation costs related to options, which are expected to be recognized over a weighted-average period of 3.33 years.

Options outstanding that have vested and are expected to vest at June 30, 2018 are as follows:

 

 

Number of

Shares   Issued

 

 

Weighted   Average

Exercise Price

 

 

Weighted   Average Remaining Contractual Life (Years)

 

 

Aggregate

Intrinsic   Value

(In   Thousands)

 

Vested

 

 

991,627

 

 

$

6.57

 

 

 

6.73

 

 

$

7,400

 

Expected to vest

 

 

1,360,609

 

 

 

7.83

 

 

 

7.54

 

 

 

6,191

 

Total

 

 

2,352,236

 

 

 

 

 

 

 

 

 

 

$

13,591

 

2014 Employee Stock Purchase Plan

During the offering period in 2017 that ended on December 31, 2017, 34,176 shares were purchased for aggregate proceeds of $0.1 million from the issuance of shares, which occurred on January 4, 2018.  During the offering period in 2018 that ended on June 30, 2018, 42,534 shares were purchased for aggregate proceeds of $0.3 million from the issuance of shares, which occurred on July 2, 2018.

28


 

Valuation Assumptions

The estimated fair values of employee stock options and ESPP shares were estimated using the Black-Scholes option-pricing model based on the following weighted-average assumptions:

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Employee stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Expected term (in years)

 

 

6.0

 

 

 

6.0

 

 

 

6.0

 

 

 

6.0

 

Expected volatility

 

 

66.00

%

 

55.46-57.71%

 

 

 

68.75

%

 

53.07%-57.71%

 

Risk-free interest rate

 

 

2.76

%

 

1.90-1.96%

 

 

 

2.71

%

 

1.90%-2.12%

 

Expected dividend yield

 

 

%

 

 

%

 

 

%

 

 

%

Employee stock purchase plan

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Expected term (in years)

 

 

0.5

 

 

 

0.5

 

 

 

0.5

 

 

 

0.5

 

Expected volatility

 

 

105.32

%

 

 

62.27

%

 

 

105.32

%

 

 

62.27

%

Risk-free interest rate

 

 

1.61

%

 

 

0.65

%

 

 

1.61

%

 

 

0.65

%

Expected dividend yield

 

 

%

 

 

%

 

 

%

 

 

%

Risk-free Interest Rate : The Company based the risk-free interest rate over the expected term of the award based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of grant.

Volatility: The Company used an average historical stock price volatility of its own stock and those comparable public companies that were deemed to be representative of future stock price trends.

Expected Term: The expected term represents the period for which the Company’s stock-based compensation awards are expected to be outstanding and is based on analyzing the vesting and contractual terms of the awards and the holders’ historical exercise patterns and termination behavior.

Expected Dividends: The Company has not paid and does not anticipate paying any dividends in the near future.

Stock-based Compensation Expense

The following table summarizes stock-based compensation expense relating to employee and nonemployee stock options, RSUs and ESPP shares for the three and six months ended June 30, 2018 and 2017, included in the statements of operations as follows (in thousands): 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Cost of testing

 

$

191

 

 

$

63

 

 

$

252

 

 

$

119

 

Research and development

 

 

462

 

 

 

111

 

 

 

675

 

 

 

175

 

Sales and marketing

 

 

466

 

 

 

57

 

 

 

529

 

 

 

95

 

General and administrative

 

 

1,393

 

 

 

264

 

 

 

1,761

 

 

 

497

 

Total

 

$

2,512

 

 

$

495

 

 

$

3,217

 

 

$

886

 

 

 

No tax benefit was recognized related to share-based compensation expense since the Company has never reported taxable income and has established a full valuation allowance to offset all of the potential tax benefits associated with its deferred tax assets.  In addition, no amounts of stock-based compensation expense were capitalized for the periods presented.

 

 

15. INCOME TAXES

The Company’s effective tax rate may vary from the U.S. federal statutory tax rate due to the change in the mix of earnings in tax jurisdictions with different statutory rates, benefits related to tax credits, and the tax impact of non-deductible expenses and other permanent differences between income before income taxes and taxable income.  For each of the three months ended June 30, 2018 and 2017, the Company recorded an income tax benefit of $0.4 million.  For the six months ended June 30, 2018 and 2017, the Company recorded an income tax benefit of $0.8 million and $0.7 million, respectively.  The income tax benefit of $0.4 million and $0.8 million for the three and six months ended June 30, 2018, respectively, is primarily attributable to the recognition of deferred tax assets from foreign losses.  The Company assesses the realizability of its net deferred tax assets by evaluating all available evidence, both positive and negative, including (i) cumulative results of operations in recent years, (ii) sources of recent losses, (iii) estimates of

29


 

future taxable income and (iv) the length of net operating loss carryforward periods.  The Company believes that based on the history of its U.S. losses and other factors, the weight of available evidence indicates that it is mor e likely than not that it will not be able to realize its U.S. net deferred tax assets. Accordingly, the U.S. net deferred tax assets have been offset by a full valuation allowance.

In accordance with the SEC’s Staff Accounting Bulletin No. 118 (“SAB 118”), the effects of the Tax Act may be adjusted within a one-year measurement period from the enactment date for items that were previously reported as provisional, or where a provisional estimate could not be made. Income tax provision for the three and six months ended June 30, 2018, did not reflect any adjustment to the previously assessed Tax Act enactment effect. The Company will continue to assess forthcoming guidance and accounting interpretations on the effects of the Tax Act and expects to complete its analysis within the measurement period in accordance with the SEC guidance.

Starting in 2018, companies may be subject to global intangible low tax income (“GILTI”), which is a tax on foreign income in excess of a deemed return on tangible assets of foreign corporations as well as the new base erosion anti-abuse tax (“BEAT”) under the Tax Act. GILTI will be effectively taxed at a tax rate of 10.5%. Due to the complexity of the GILTI tax rules, companies are allowed to make an accounting policy choice of either (1) treating taxes due on future U.S. inclusions in taxable income related to GILTI as a current-period expense when incurred or (2) factoring such amounts into a company’s measurement of its deferred taxes under SAB 118. The Company has not yet made an election with respect to GILTI and does not believe GILTI will have an impact on the Company’s 2018 taxes. The Company will continue to review the GILTI and BEAT rules to determine their applicability to the Company as the rules become effective.

 

16. SEGMENT REPORTING

Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated regularly by the Chief Operating Decision Maker (“CODM”), or decision making group, whose function is to allocate resources to and assess the performance of the operating segments.  The Company has identified its chief executive officer as the CODM.  In determining its reportable segments, the Company considered the markets and types of customers served and the products or services provided in those markets.

The Company has identified the following two reportable segments, which are the same as its operating segments:

 

Post-Transplant: This segment focuses on discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients.  In post-transplant diagnostics, the Company offers AlloMap, which is a heart transplant molecular test and AlloSure, which is a donor-derived cell free DNA (“dd-cfDNA”) test initially used for kidney transplant patients.  

 

Pre-Transplant: This segment develops, manufactures, markets and sells high quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs.  The pre-transplant product lines include Olerup branded products SSP, SBT, QTYPE and TruSight HLA.

There were no intersegment sales for the three and six months ended June 30, 2018 or 2017. The following table summarizes the operating results of the Company’s reportable segments (in thousands):

 

 

 

Three   Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Total Segments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

$

17,823

 

 

$

12,046

 

 

$

31,876

 

 

$

23,630

 

Operating loss

 

 

(5,209

)

 

 

(3,599

)

 

 

(10,444

)

 

 

(12,143

)

Depreciation and amortization

 

 

986

 

 

 

887

 

 

 

2,025

 

 

 

1,821

 

Post-Transplant

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

$

14,171

 

 

$

8,670

 

 

$

24,917

 

 

$

16,587

 

Operating loss

 

 

(3,138

)

 

 

(2,662

)

 

 

(6,333

)

 

 

(8,121

)

Depreciation and amortization

 

 

316

 

 

 

236

 

 

 

645

 

 

 

498

 

Pre-Transplant

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

$

3,652

 

 

$

3,376

 

 

$

6,959

 

 

$

7,043

 

Operating loss

 

 

(2,071

)

 

 

(937

)

 

 

(4,111

)

 

 

(4,022

)

Depreciation and amortization

 

 

670

 

 

 

651

 

 

 

1,380

 

 

 

1,323

 

30


 

 

 

 

June 30,   2018

 

 

December   31,   2017

 

Assets:

 

 

 

 

 

 

 

 

Post-Transplant

 

$

48,851

 

 

$

48,734

 

Pre-Transplant

 

 

31,028

 

 

 

34,831

 

Total assets

 

$

79,879

 

 

$

83,565

 

Revenues by geographic regions are based upon the customers’ ship-to address for pre-transplant product revenues and the region of testing for post-transplant service revenue.  The following table summarizes reportable revenues by geographic regions (in thousands):

 

 

 

Three   Months Ended June 30, 2018

 

 

Three   Months Ended June 30, 2017

 

 

 

Post-Transplant

 

 

Pre-Transplant

 

 

Post-Transplant

 

 

Pre-Transplant

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

North America

 

$

14,147

 

 

$

1,489

 

 

$

8,647

 

 

$

983

 

Europe

 

 

24

 

 

 

1,856

 

 

 

23

 

 

 

1,863

 

Australia

 

 

 

 

 

31

 

 

 

 

 

 

125

 

Rest of the World

 

 

 

 

 

276

 

 

 

 

 

 

405

 

Total

 

$

14,171

 

 

$

3,652

 

 

$

8,670

 

 

$

3,376

 

 

 

 

 

Six   Months Ended June 30, 2018

 

 

Six   Months Ended June 30, 2017

 

 

 

Post-Transplant

 

 

Pre-Transplant

 

 

Post-Transplant

 

 

Pre-Transplant

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

North America

 

$

24,876

 

 

$

2,418

 

 

$

16,549

 

 

$

1,983

 

Europe

 

 

41

 

 

 

3,829

 

 

 

38

 

 

 

3,922

 

Australia

 

 

 

 

 

105

 

 

 

 

 

 

241

 

Rest of the World

 

 

 

 

 

607

 

 

 

 

 

 

897

 

Total

 

$

24,917

 

 

$

6,959

 

 

$

16,587

 

 

$

7,043

 

 

The following table summarizes long-lived assets, consisting of property and equipment, net, by geographic regions (in thousands):

 

 

 

June 30, 2018

 

 

December   31,   2017

 

Long-lived assets:

 

 

 

 

 

 

 

 

North America

 

$

1,572

 

 

$

1,206

 

Europe

 

 

708

 

 

 

776

 

Australia

 

 

80

 

 

 

93

 

Total

 

$

2,360

 

 

$

2,075

 

 

31


 

ITEM 2.

M ANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read together with the unaudited condensed consolidated financial statements and related notes included elsewhere in Item 1 of Part I of this Quarterly Report on Form 10-Q and with the audited financial statements and the related notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the Securities and Exchange Commission, or the SEC, on March 22, 2018.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  All statements contained in this Quarterly Report on Form 10-Q other than statements of historical fact, including statements regarding our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements.  The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” and the negative and plural forms of these words and similar expressions are intended to identify forward-looking statements.

These forward-looking statements may include, but are not limited to, statements concerning the following:

 

our ability to generate revenue from sales of AlloMap, AlloSure and future testing services, if any, and our ability to increase the commercial success of these testing services;

 

our ability to generate revenue from sales of Olerup SSP, Olerup SBT, Olerup QTYPE, TruSight HLA, and future  products, if any, and our ability to increase the commercial success of these products;

 

our ability to generate revenue from the license and commercialization agreement with Illumina, Inc.;

 

our plans and ability to develop and commercialize new solutions for the surveillance of heart, kidney, and other solid organ transplant recipients; our plans and ability to continue updating our products, services and technology to maintain our leading position in the surveillance market for solid organ transplants;

 

our plans and ability to continue updating our sequence specific primer products and technology to maintain our leading position in the SSP market;

 

our plans and ability to develop, commercialize, and/or distribute new gene expression, cell free DNA and Next Generation Sequencing technology and post-transplant solutions;

 

our ability to obtain additional financing on terms favorable to us, or at all;

 

our ability to remain eligible to use Registration Statements on Form S-3 for capital-raising transactions;

 

our ability to obtain, maintain and expand reimbursement coverage from payers for AlloMap, AlloSure and other future testing services, if any;  

 

the outcome or success of our clinical trial collaborations and registry studies;

 

our dependence on certain of our suppliers, service providers, and other distribution partners;

 

our compliance with federal, state and foreign regulatory requirements;

 

the favorable review of our testing services and product offerings, and our future solutions, if any, in peer-reviewed publications;

 

our ability to protect and enforce our intellectual property rights, our strategies regarding filing additional patent applications to strengthen our intellectual property rights, and our ability to defend against intellectual property claims that may be brought against us;

 

our anticipated cash needs and our anticipated uses of our funds, including our estimates regarding operating expenses and capital requirements;

 

our ability to meet our obligations under our equity financing agreements and debt agreements;

 

anticipated trends and challenges in our business and the markets in which we operate;

 

disruptions to our business, including disruptions at our laboratories and manufacturing facilities;

 

our ability to retain key members of our management team;

32


 

 

our ability to make successful acquisitions or investments and to manage the integration of such acquisitions or investments;

 

our ability to successfully defend against or settle any litigation brought against us or other legal matters or disputes;

 

our ability to expand internationally; and

 

our ability to comply with the requirements of being a public company.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the section entitled “Risk Factors” in this Quarterly Report on Form 10-Q.  Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time.  It is not possible for us to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially and adversely from those contained in any forward-looking statements we may make.  In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events.  Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur.  Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements.  Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this report to conform these statements to actual results or to changes in our expectations.

You should read this report and the documents that we reference in this report and have filed with the SEC as exhibits with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect.  We qualify all forward-looking statements by these cautionary statements.

Overview and Recent Highlights

We are a global transplant diagnostics company with product offerings along the pre- and post-transplant continuum.  We focus on discovery, development and commercialization of clinically differentiated, high-value diagnostic surveillance solutions for transplant patients.

Testing Services

AlloMap

Our first commercialized testing solution, the AlloMap heart transplant molecular test, or AlloMap, is a gene expression test that helps clinicians monitor and identify heart transplant recipients with stable graft function who have a low probability of moderate-to-severe acute cellular rejection.  Since 2005, we have sought to expand the adoption and utilization of our AlloMap solution through ongoing studies to substantiate the clinical utility and actionability of AlloMap, secure positive reimbursement decisions for AlloMap from large private and public payers, develop and enhance our relationships with key members of the transplant community, including opinion leaders at major transplant centers, and explore opportunities and technologies for the development of additional solutions for post-transplant surveillance.  We believe the use of AlloMap, in conjunction with other clinical indicators, can help healthcare providers and their patients better manage long-term care following a heart transplant. In particular, we believe AlloMap can improve patient care by helping healthcare providers avoid the use of unnecessary, invasive surveillance biopsies and determine the appropriate dosage levels of immunosuppressants.  In 2008, AlloMap received 510(k) clearance in 2008, from the U.S. Food and Drug Administration, or FDA, for marketing and sale as a test to aid in the identification of recipients with a low probability of moderate or severe acute cellular rejection.  

AlloMap has received positive coverage decisions for reimbursement from Medicare.  The 2018 reimbursement rate for AlloMap is $3,240, which represents a 14% increase over the 2017 reimbursement rate.  AlloMap has also received positive coverage decisions for reimbursement from many of the largest U.S. private payers, including Aetna, Anthem, Cigna, Health Care Services Corporation (HCSC), Humana, Kaiser Foundation Health Plan, Inc., and TRICARE.

We have also successfully completed a number of landmark clinical trials in the transplant field demonstrating the clinical utility of AlloMap for surveillance of heart transplant recipients.  We initially established the analytical and clinical validity of AlloMap on the basis of our Cardiac Allograft Rejection Gene Expression Observational (Deng, M. et al., Am J Transplantation 2006), or CARGO, study, which was published in the American Journal of Transplantation . A subsequent clinical utility trial, Invasive Monitoring Attenuation through Gene Expression (Pham MX et al., N. Eng. J. Med., 2010), or IMAGE, published in The New England Journal of

33


 

Medicine, demonstrated that clinical outcomes in recipients managed with All oMap surveillance were equivalent (non-inferior) to outcomes in recipients managed with biopsies.  The results of our clinical trials have also been presented at major medical society congresses.

During the first six months of 2018, there were 7,979 AlloMap patient test results provided to 128 of the approximately 135 heart transplant management centers in the United States.  

AlloSure

AlloSure, our recently launched commercial transplant surveillance solution, applies proprietary next generation sequencing technology to measure donor-derived cell free DNA, or dd-cfDNA in the blood stream emanating from the donor kidney or heart.  We believe AlloSure may help clinicians determine rejection-specific activity manifested as cell damage in the transplanted heart, kidney and other solid organs, irrespective of the type of organ transplanted.  We also believe the use of AlloSure, in conjunction with other clinical indicators, can help healthcare providers and their patients better manage long-term care following a kidney transplant. In particular, we believe AlloSure can improve patient care by helping healthcare providers to reduce the use of invasive biopsies and determine the appropriate dosage levels of immunosuppressants. Effective October 9, 2017, AlloSure became available for commercial testing with Medicare coverage and reimbursement. The Medicare reimbursement rate for AlloSure is $2,841. AlloSure has also received payment from private payers on a case-by-case basis, but no positive coverage decisions have been made.   

 

Prior to the commercialization of AlloSure, we generated a strong body of clinical evidence.  In late 2015, we announced the completion of analytical validation of AlloSure.  A report describing the analytical validation of AlloSure including clinical validation detailing the quality, reality, and consistency of analytical results information for heart transplant, appeared in the November 2016 issue of The Journal of Molecular Diagnostics.  The Circulating Donor-Derived Cell-Free DNA in Blood for Diagnosing Acute Rejection in Kidney Transplant Recipients, or DART, trial, sponsored by us, was conducted between April 2015 and January 2018.  DART is a 14 center observational study of kidney transplant recipients where blood specimens are drawn periodically after transplant during follow up visits and also after treatment for acute rejection.  By the time of completion of the first analysis, 384 patients were followed in DART for up to 24 months.  The results demonstrated that increased levels of dd-cfDNA, determined by the AlloSure assay, discriminated active rejection of a kidney transplant more effectively than serum creatinine values. In collaboration with clinical investigators, we published these findings in the scientific peer-reviewed Journal of the American Society of Nephrology and the Journal Applied Laboratory Medicine in March 2017. A total of 2,109 patient visits had been accrued in DART by January 2018; we plan to analyze and report on additional findings from this dataset in 2018 and into the future.  

In late 2017, we established the Kidney Allograft Outcomes AlloSure Registry, or K-OAR, study to develop further data on the clinical utility of AlloSure for surveillance of kidney transplant recipients. We will invite 35 centers to join K-OAR, and we anticipate staggered activation of these study centers throughout 2018 .   As of June 30, 2018, 27 centers have been initiated as K-OAR study sites.

During the first six months of 2018, there were 3,351 AlloSure patient test results provided.  Since launch, AlloSure has been ordered by 76 kidney transplant centers in the United States.

Products

We develop, manufacture, market and sell products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. Olerup SSP® is used to type Human Leukocyte Antigen, or HLA alleles, based on the sequence specific primer, or SSP technology.  Olerup SBT TM is a complete product range for sequence-based typing of HLA alleles. Olerup QTYPE enables speed and precision in HLA typing at a low to intermediate resolution for samples that require a fast turn-around-time and uses real-time polymerase chain reaction, or PCR, methodology. QTYPE received CE mark certification on April 10, 2018.  

On May 4, 2018, we entered into a License and Commercialization Agreement (the “License Agreement”) with Illumina, Inc. (“Illumina”), which provides us with worldwide distribution, development and commercialization rights to Illumina’s next generation sequencing (“NGS”) product line for use in transplantation diagnostic testing.

As a result, on June 1, 2018, we became the exclusive worldwide distributor of Illumina’s TruSight HLA product line. In addition, we were granted the exclusive right to develop and commercialize other NGS product lines for use in the field of bone marrow and solid organ transplantation diagnostic testing.

34


 

Recent Highlights

 

Accelerated AlloSure penetration in key kidney transplant centers

 

-

As of June 30, 2018, 76 U.S. transplant centers have provided AlloSure testing

 

-

Continued progress in AlloSure K-OAR enrollment, with 27 centers initiated as of June 30, 2018 and 237 K-OAR patients enrolled

 

-

Notable presence at the 2018 American Transplant Congress including a standing room only symposium on clinical experiences with AlloSure.

 

Achieved total revenue of $17.8 million for the second quarter of 2018, increasing 48% year-over-year

 

-

Testing services revenue of $14.0 million, with 2,300 AlloSure and 4,132 AlloMap patient results provided

 

-

Product revenue of $3.6 million.

 

Broadened testing services and product offerings

 

-

Entered into partnership with Illumina to develop and sell Next Generation Sequencing transplant products

 

-

Launched HeartCare, a comprehensive solution for surveillance of heart transplant patients, combining AlloMap with AlloSure-Heart

 

-

Validated Olerup QTYPE on multiple platforms and received CE mark certification.

Financial Operations Overview

Revenue

We derive our revenue from testing services, products sales and license and other revenues. On January 1, 2018, we adopted the new revenue accounting standard Revenue from Contracts with Customers (Topic 606) , or ASC 606, using the modified retrospective method. The adoption of ASC 606 resulted in a one-time adjustment of $2.9 million to accounts receivable and retained earnings.  This adjustment reflects the estimated payments to be received for tests where the result had been delivered at December 31, 2017, but the associated revenue had not been recognized by December 31, 2017, because payment had not been received. Under the new accounting standard, revenue is recorded considering a five-step model that includes identifying the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating the transaction price to the performance obligations and recognizing revenue when, or as, an entity satisfies a performance obligation.

Testing Services Revenue

Our testing revenue is derived from AlloMap and AlloSure tests, which represented 79% and 77% of our total revenues for the three and six months ended June 30, 2018, respectively, and 70% and 69% of our total revenues for the three and six months ended June 30, 2017, respectively.  We currently market AlloMap and AlloSure in the U.S. to healthcare providers through our direct sales force that targets transplant centers and their physicians, coordinators and nurse practitioners.  The healthcare providers that order the tests and on whose behalf we provide our testing services are generally not responsible for the payment of these services.  Amounts received by us vary from payer to payer based on each payer’s internal coverage practices and policies. We generally bill third-party payers upon delivery of an AlloMap or AlloSure test result report to the healthcare provider.  As such, we take the assignment of benefits and the risk of collection from the third-party payer and individual patients.

Product Revenue

Our product revenue is derived primarily from sales of Olerup and TruSight branded products.  Product revenue represented 20% and 22% of total revenue for the three and six months ended June 30, 2018, respectively, and 28% and 30% of total revenue for the three and six months ended June 30, 2017, respectively.  Product revenue is recognized from the sale of products to end-users, distributors and strategic partners when all revenue recognition criteria are satisfied, which is generally upon the product shipment.  

License and Other Revenue

License agreements may include non-refundable upfront payments, partial or complete reimbursement of research and development costs, contingent payments based on the occurrence of specified events under the agreements, license fees and royalties on sales of products or product candidates if they are successfully commercialized.  Our performance obligations under the license agreements may include the transfer of intellectual property rights in the form of licenses, obligations to provide research and development services and obligations to participate on certain development committees.  We make judgments that affect the periods over which we recognize revenue.  We review our estimated periods of performance based on the progress under each arrangement and account for the impact of any change in estimated revenues.

We did not recognize any revenue connected with milestones during the three or six months ended June 30, 2018 or 2017.

35


 

Cost of Testing Services

Cost of testing services reflects the aggregate costs incurred in delivering our testing services.  The components of cost of testing services are materials and service costs, direct labor costs, stock-based compensation expense, equipment and infrastructure expenses associated with testing samples, shipping, logistics and specimen processing charges to collect and transport samples and allocated overhead including rent, information technology, equipment depreciation, utilities and royalties.  Prior to adoption of the new revenue guidance, we recorded cost of testing services associated with performing tests (except royalties) in the period when tests were performed without consideration of whether revenue was recognized in the same period. With the adoption of the new revenue standard on January 1, 2018, revenue and cost of testing services for tests performed are recognized in the same period. Royalties for licensed technology, calculated as a percentage of test revenues, are recorded as license fees in cost of testing at the time the test revenues are recognized.

Cost of Product

Cost of product reflects the aggregate costs incurred in delivering our products to customers.  The components of cost of product are material costs, manufacturing and kit assembly costs, direct labor costs, including equipment and infrastructure expenses associated with preparing kitted products for shipment, shipping, distributorship agreements and allocated overhead, including rent, information technology, equipment depreciation and utilities.  Cost of product also includes amortization of acquired developed technology and adjustments to inventory values, including write-down of impaired, slow moving or obsolete inventory.

Research and Development Expenses

Research and development expenses, including clinical operations, represent costs incurred to develop diagnostic products and services, high quality evidence to support use of our tests, as well as continued efforts related to improving our existing product and service lines.  These expenses include payroll and related expenses, consulting expenses, laboratory supplies, clinical studies and certain allocated expenses as well as amounts incurred under certain collaborative agreements. Research and development costs are expensed as incurred.  We record accruals for estimated study costs comprised of work performed by contract research organizations under contract terms.  

Sales and Marketing Expenses

Sales and marketing expenses represent costs incurred to sell, promote and increase awareness of our existing products and services to transplant centers and hospital laboratories.  These efforts also include education of patients, clinicians, payers, and other relevant decision makers.  Sales and marketing expenses include payroll and related expenses, educational and promotional expenses, and infrastructure expenses, including allocated facility and overhead costs.  Compensation related to sales and marketing includes annual salaries and eligibility for periodic bonuses based on the achievement of predetermined sales goals or other management objectives.

General and Administrative Expenses

General and administrative expenses include costs for our executive, finance, accounting and human resources functions.  Costs consist primarily of payroll and related expenses, professional service fees related to audit and accounting, certain financing transaction expenses, and legal and other contract and administrative services.  We will continue to incur expenses as a result of operating as a public company.

Goodwill Impairment

We test goodwill and indefinite-lived intangibles for impairment at least annually and more frequently if impairment indicators are present.  In the three months ended March 31, 2017, we determined that the decrease in our market capitalization constituted an indicator of impairment and therefore a goodwill impairment test was completed as of March 31, 2017.  We identified an impairment of $2.0 million related to goodwill allocated to the Pre-Transplant reporting unit.  

No goodwill impairment indicators were present in the three or six months ended June 30, 2018 and therefore no impairment was recorded.

Change in Estimated Fair Value of Contingent Consideration

We revalue our contingent consideration obligation liability in connection with our acquisition of IMX in 2014 at each reporting period.  Changes in the fair value of our contingent consideration obligation are recognized as a component of operating expense within our condensed consolidated statements of operations.  We achieved the contingent consideration obligation milestone of 2,500 commercial tests and issued 227,845 shares in the period ended June 30, 2018.  There is no contingent consideration outstanding as of June 30, 2018.

36


 

Interest Expense

Interest expense is associated with borrowings under our loan agreements and also includes debt discount amortization.

Other Expense

Other expense includes gains and losses on foreign currency transactions, on debt extinguishment, and other miscellaneous expenses.  During the six months ended June 30, 2018 we recorded $2.8 million loss on the conversion of the JGB debt as the difference between the value of the shares of common stock issued on the days of conversion and the amount of principal debt converted on those days, net of the allocated debt discount and derivative liability balances.

Change in Estimated Fair Value of Common Stock Warrant Liability and Derivative Liability

Common stock warrants issued in connection with our debt and equity financings are considered freestanding financial instruments and are analyzed as to whether they meet equity or liability classification in accordance with US GAAP. Warrants that meet liability classification are re-measured at each period end with changes in fair value recorded in our condensed consolidated statements of operations until these warrants are exercised or expire. On January 1, 2018, we adopted Accounting Standards Update No. 2017-11, Accounting for Certain Financial Instruments with Down Round Features and Replacement of the Indefinite Deferral of Mandatorily Redeemable Financial Instruments of Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception and this resulted in the liability balance for our warrants issued to JGB being reclassified to equity on the date of adoption.  

The JGB debt included certain embedded derivatives that required bifurcation, including settlement and penalty provisions.  The embedded derivative was remeasured at each reporting period with changes recorded in change in estimated fair value of common stock warrant liability and derivative liability in the condensed consolidated statements of operations.  As of March 27, 2018, the JGB debt had fully converted to shares of our common stock.   On April 17, 2018, we entered into the Perceptive Credit Agreement, which included an embedded derivative that required bifurcation related to early repayment provision.   We record changes in the fair value of the derivative liabilities in the change in estimated value of common stock warrant liability and derivative liability in our condensed consolidated statements of operations.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles, or U.S. GAAP.  The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods.  Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.  Actual results may differ from these estimates under different assumptions or conditions.

Our significant accounting policies are described in Note 2 of the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information. Some of these accounting policies require us to make difficult and subjective judgments, often as a result of the need to make estimates of matters that are inherently uncertain. We believe that the following critical accounting policies reflect the more significant estimates and assumptions used in the preparation of our financial statements. We believe the following critical accounting policies are affected by significant judgments and estimates used in the preparation of our Condensed Consolidated Financial Statements:

 

Revenue recognition – estimation of variable consideration

 

Determination of the accruals for clinical studies,

 

Inventory valuation

 

Valuation of common stock warrant liability

 

Valuation of embedded derivative liability

 

Valuation and impairment of goodwill, intangible assets and other long-lived assets;

 

Goodwill and acquired intangible assets

 

Share-based compensation; and

 

Accounting for income taxes.

37


 

There were no material changes in the matters for which we make critical accoun ting estimates in the preparation of our Condensed Consolidated Financial Statements during the three and six months ended June 30, 2018 as compared to those disclosed in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our annual report on Form 10-K for the year ended December 31, 2017, except as discussed in Note 2, Summary of Significant Accounting Policies, to the Condensed Consolidated Financial Statements in this quarterly report.

Recently Issued Accounting Standards

Refer to Note 2, Summary of Significant Accounting Policies - Recent Accounting Pronouncements, of the Notes to Condensed Consolidated Financial Statements in this quarterly report for a description of recently issued accounting pronouncements, including the expected dates of adoption and estimated effects on our results of operations, financial position and cash flows.

Results of Operations

Comparison of the Three Months Ended June 30, 2018 and 2017

(In thousands)

 

 

 

Three Months Ended June 30,

 

 

 

 

 

 

 

2018

 

 

2017

 

 

Change

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Testing services revenue

 

$

13,997

 

 

$

8,420

 

 

$

5,577

 

Product revenue

 

 

3,550

 

 

 

3,376

 

 

 

174

 

License and other revenue

 

 

276

 

 

 

250

 

 

 

26

 

Total revenue

 

 

17,823

 

 

 

12,046

 

 

 

5,777

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of testing services

 

 

4,568

 

 

 

3,011

 

 

 

1,557

 

Cost of product

 

 

2,639

 

 

 

2,178

 

 

 

461

 

Research and development

 

 

3,496

 

 

 

3,118

 

 

 

378

 

Sales and marketing

 

 

5,860

 

 

 

3,270

 

 

 

2,590

 

General and administrative

 

 

5,596

 

 

 

4,132

 

 

 

1,464

 

Change in estimated fair value of contingent consideration

 

 

873

 

 

 

(64

)

 

 

937

 

Total operating expenses

 

 

23,032

 

 

 

15,645

 

 

 

7,387

 

Loss from operations

 

 

(5,209

)

 

 

(3,599

)

 

 

(1,610

)

Interest expense

 

 

(424

)

 

 

(1,691

)

 

 

1,267

 

Other expense, net

 

 

(42

)

 

 

(188

)

 

 

146

 

Change in estimated fair value of common stock warrant liability and derivative liability

 

 

(8,768

)

 

 

1,067

 

 

 

(9,835

)

Income tax benefit

 

 

381

 

 

 

376

 

 

 

5

 

Net loss

 

 

(14,062

)

 

 

(4,035

)

 

 

(10,027

)

Net loss attributable to noncontrolling interest

 

 

 

 

 

(67

)

 

 

67

 

Net loss attributable to CareDx, Inc.

 

$

(14,062

)

 

$

(3,968

)

 

$

(10,094

)

Testing Services Revenue

Testing services revenue increased by $5.6 million, or 66%, for the three months ended June 30, 2018 as compared to the same period in 2017.  This increase is mainly due to the 2,300 AlloSure test results provided in the three months ended June 30, 2018, following the launch of AlloSure in October 2017.  Additionally, AlloMap test results increased to 4,132 in the three months ended June 30, 2018, compared to 3,861 in the same period in 2017, and the Medicare reimbursement rate for AlloMap increased from $2,841 to $3,240 on January 1, 2018.

As described in Note 2 of the Condensed Consolidated Financial Statements, the adoption of ASC 606 on January 1, 2018, had a $0.5 million favorable impact on Testing Revenue for the three months ended June 30, 2018, compared to the revenue under the methodology used in the three months ended June 30, 2017.

38


 

Product Revenue

Product revenue increased by $0.2 million, or 5%, for the three months ended June 30, 2018, compared to the same period in 2017. The increase was due to increased sales of QTYPE and TruSight products related to the License Agreement with Illumina, partially offset by decreased sales of SSP and SBT products.

License and Other Revenue

License, and other revenue increased by less than $0.1 million for the three months ended June 30, 2018, compared to the same period in 2017.

Cost of Testing Services

Cost of testing services increased by approximately $1.6 million, or 52%, for the three months ended June 30, 2018, compared to the same period in 2017, primarily due to the increase in test results provided for both AlloMap and AlloSure.  

Cost of Product

Cost of product increased by $0.5 million, or 21%, for the three months ended June 30, 2018, compared to the same period in 2017.  The increase in cost of product in the three months ended June 30, 2018 mainly reflects $0.4 million charge related to an increase in inventory obsolescence provision.

Research and Development

Research and development expenses increased by $0.4 million, or 12%, for the three months ended June 30, 2018, compared to the same period in 2017 due to an increase in an increase personnel related expenses of $0.2 million, an increase of stock-based compensation expense of $0.1 million and an increase in materials of $0.2 million, partially offset by decreased QTYPE development fees of $0.1 million.

Sales and Marketing

Sales and marketing expenses increased by approximately $2.6 million, or 79%, for the three months ended June 30, 2018, compared to the same period in 2017, primarily due to higher personnel related costs of $1.2 million associated with increased headcount, higher conference fees and travel costs associated with several key transplant industry events of $0.9 million, and increased stock-based compensation expense of $0.4 million.

General and Administrative

General and administrative expenses increased by $1.5 million, or 35%, for the three months ended June 30, 2018, compared to the same period in 2017.  This increase primarily reflects a $1.1 million increase in stock-based compensation expense, an increase of $0.3 million in personnel related expenses and a $0.3 million increase in expense related to the timing of audit and tax fees in 2018 as compared to the 2017 period, offset by lower legal fees of $0.2 million.

Change in Estimated Fair Value of Contingent Consideration

We estimated the contingent consideration liability fair value at each period end based on our common stock price at the end of the period and a probability of meeting the contractual milestone related to the number of tests sold by June 2020, in accordance with the IMX acquisition agreement.  The contingent consideration liability was settled in the three months ended June 30, 2018, with the achievement of the contractual milestone of 2,500 AlloSure tests.  Changes in the fair value of the contingent liability were $0.9 million expense compared to $0.1 million income for the three months ended June 30, 2018 and 2017 respectively.  The $0.9 million expense reflected an increase in our share price from April 1, 2018 to the date of issuance of the 227,845 shares and settlement of the liability.

Interest Expense

Interest expense decreased by $1.3 million for the three months ended June 30, 2018, compared to the same period in 2017. The interest expense of $0.4 million in the three months ended June 30, 2018, consisted primarily of interest expense and debt amortization recorded in relation to the Perceptive Credit Agreement entered into on April 17, 2018.

The interest expense of $1.7 million in the three months ended June 30, 2017, consisted of $1.3 million of interest expense and debt discount amortization related to the JGB debt, $0.2 million of interest expense recorded in relation to deferred purchase consideration owed to the former shareholders of Allenex and $0.2 million in interest expense recorded on the Allenex Notes, the Danske Bank Term Loan and the SSP Primers Loan.

39


 

The JGB Debt was entered into on March 15, 2017 and during the three months ended March 31, 2018 was converted into shares of our common stock. The deferred purchase consideration was re lated to the acquisition of Allenex and was settled in November 2017. The SSP Primers Loan was repaid in February 2018 and the Allenex Notes and Danske Bank Term Loan were repaid in April 2018.

Other Expense, Net

Other expense decreased by $0.1 million in the three months ended June 30, 2018 compared to 2017.  For the three months ended June 30, 2018, other expenses included $0.1 million in taxes and $48,000 in other charges, partially offset by $0.1 million in foreign exchange gains.  For the three months ended June 30, 2017, foreign exchange losses of $0.3 million were offset by a $0.1 million adjustment on the payment to settle a litigation liability.

Change in Estimated Fair Value of Common Stock Warrant Liability and Derivative Liability

The change in estimated fair value of common stock warrant liability and derivative liability was $8.8 million expense in the three months ended June 30, 2018 and $1.1 million income in the comparative period in 2017.

The $8.8 million expense in the three months ended June 30, 2018 consisted of a $5.2 million remeasurement charge for warrants exercised during the period and a $3.6 million remeasurement charge related to the changes in fair value of our remaining common stock warrant liability. These remeasurement charges reflect the increase in the price of shares of our common stock during the three months ended June 30, 2018.

The $1.1 million income in the three months ended June 30, 2017, consisted of a remeasurement gain to reflect the decline in the price of shares of our common stock during this three month period.

As of January 1, 2018, we adopted the new accounting standard and reclassified the outstanding common stock warrant issued in connection with the JGB debt to equity. This warrant is not re-measured through earnings after January 1, 2018. Similarly, the Perceptive Tranche A Warrant, issued on April 17, 2018, by the Company in accordance with the Perceptive Credit Agreement, was classified as equity and excluded from the quarterly remeasurement.  Warrants issued in connection with a Private Placement transaction completed on April 14, 2016, and a subsequent financing completed on June 15, 2016 continue to be classified as liability and will be re-measured at the end of each reporting period until expired or exercised. Changes in the common stock fair value, estimated volatility and expected contractual term will significantly impact the fair value of the warrant liability.

Income Tax Benefit

For the three months ended June 30, 2018, we recorded an income tax benefit of $0.4 million on a loss before income taxes of $14.4 million.  This benefit primarily resulted from the expectation that amortization of the various intangible assets acquired, when completed and placed in service, is not expected to be deductible for tax purposes. Accordingly, a deferred tax liability was recorded at the acquisition date for the difference between the financial reporting and tax basis of the intangibles.

40


 

Comparison of the Six Months Ended June 30, 2018 and 2017

(In thousands)

 

 

Six Months Ended June 30,

 

 

 

 

 

 

 

2018

 

 

2017

 

 

Change

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Testing services revenue

 

$

24,601

 

 

$

16,322

 

 

$

8,279

 

Product revenue

 

 

6,857

 

 

 

7,043

 

 

 

(186

)

License and other revenue

 

 

418

 

 

 

265

 

 

 

153

 

Total revenue

 

 

31,876

 

 

 

23,630

 

 

 

8,246

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of testing services

 

 

8,680

 

 

 

6,068

 

 

 

2,612

 

Cost of product

 

 

4,911

 

 

 

4,505

 

 

 

406

 

Research and development

 

 

6,864

 

 

 

6,401

 

 

 

463

 

Sales and marketing

 

 

9,945

 

 

 

6,492

 

 

 

3,453

 

General and administrative

 

 

10,903

 

 

 

10,634

 

 

 

269

 

Goodwill Impairment

 

 

 

 

 

1,958

 

 

 

(1,958

)

Change in estimated fair value of contingent consideration

 

 

1,017

 

 

 

(285

)

 

 

1,302

 

Total operating expenses

 

 

42,320

 

 

 

35,773

 

 

 

6,547

 

Loss from operations

 

 

(10,444

)

 

 

(12,143

)

 

 

1,699

 

Interest expense

 

 

(3,119

)

 

 

(2,481

)

 

 

(638

)

Other expense, net

 

 

(2,851

)

 

 

(874

)

 

 

(1,977

)

Change in estimated fair value of common stock warrant liability and derivative liability

 

 

(7,447

)

 

 

5,195

 

 

 

(12,642

)

Income tax benefit

 

 

805

 

 

 

659

 

 

 

146

 

Net loss

 

 

(23,056

)

 

 

(9,644

)

 

 

(13,412

)

Net loss attributable to noncontrolling interest

 

 

(25

)

 

 

(114

)

 

 

89

 

Net loss attributable to CareDx, Inc.

 

$

(23,031

)

 

$

(9,530

)

 

$

(13,501

)

Testing Services Revenue

Testing services revenue increased by $8.3 million, or 51%, for the six months ended June 30, 2018, compared to the same period in 2017.  This increase is mainly due to the 3,351 of AlloSure test results provided in the six months ended June 30, 2018, following the launch of AlloSure in October 2017. Additionally, AlloMap test results increased to 7,979 in the six months ended June 30, 2018, compared to 7,611 in the same period in 2017, and the Medicare reimbursement rate for AlloMap increased from $2,841 to $3,240 on January 1, 2018.

As described in Note 2 of the Condensed Consolidated Financial Statements, the adoption of ASC 606 on January 1, 2018, had a $0.5 million favorable impact on Testing Revenue for the six months ended June 30, 2018, compared to the revenue under the methodology used in the six months ended June 30, 2017.

Product Revenue

Product revenue decreased by $0.2 million, or 3%, for the six months ended June 30, 2018, due to a decrease in sales of SSP and SBT products compared to the same period in 2017, partially offset by sales of TruSight and increased sales of QTYPE.

License and Other Revenue

License and other revenue increased by $0.2 million for the six months ended June 30, 2018, which is primarily due to revenue earned from Illumina under our the License Agreement.

Cost of Testing

Cost of testing increased by approximately $2.6 million, or 43%, for the six months ended June 30, 2018, compared to the same period in 2017, primarily due to the increase in test results provided for both AlloMap and AlloSure.  

41


 

Cost of Product

Cost of product increased by $0.4 million, or 9%, for the six months ended June 30, 2018, compared to the same period in 2017.  The increase in cost of product in the six months ended June 30, 2018 mainly reflects a $0.4 million charge related to an increase in inventory obsolescence provision.

Research and Development

Research and development expenses increased by $0.5 million, or 7%, for the six months ended June 30, 2018, compared to the same period in 2017.  This increase reflects an increase of $0.5 million in stock-based compensation expense and an increase of $0.2 million of personnel related expense, partially offset by $0.2 million in decreased depreciation expense.

Sales and Marketing

Sales and marketing expenses increased by approximately $3.5 million, or 53%, for the six months ended June 30, 2018, compared to the same period in 2017, primarily due to an increase in personnel related expenses of $1.8 million, higher conference fees and travel costs associated with several key transplant industry events of $1.1 million, and increased share-based compensation expenses of $0.4 million.

General and Administrative

General and administrative expenses increased by $0.3 million, or 3%, for the six months ended June 30, 2018, compared to the same period in 2017.  This increase primarily reflects an increase of $1.2 million in stock-based compensation expense and an increase of $0.5 million in personnel related expenses, partially offset by a reduction in audit and tax fees of $1.0 million and in consulting and professional fees of $0.4 million.

Goodwill Impairment

In the three months ended March 31, 2017, we determined that the decrease in our market capitalization constituted an indicator of impairment and therefore a goodwill impairment test was completed as of March 31, 2017.  We recorded a goodwill impairment charge of $2.0 million as of March 31, 2017. No impairment was identified in the six months ended June 30, 2018 .

Change in Estimated Fair Value of Contingent Consideration

We estimated the contingent consideration liability fair value at each period end based on our common stock price at the end of the period and a probability of meeting the contractual milestone related to the number of tests sold by June 2020, in accordance with the IMX acquisition agreement. The contingent consideration liability was settled in the six months ended June 30, 2018, with the achievement of the contractual milestone of 2,500 AlloSure tests. Changes in fair value of the contingent liability were $1.0 million expense compared to $0.3 million income for the six months ended June 30, 2018 and 2017 respectively. The $1.0 million expense reflected an increase in our share price from January 1, 2018 to the date of the issuance of the 227,845 shares and the settlement of the liability.  Income of $0.3 million represented a decrease in share price for the comparable six month period in 2017.

Interest Expense

Interest expense increased by $0.6 million for the six months ended June 30, 2018, compared to the same period in 2017.

The interest expense of $3.1 million in the six months ended June 30, 2018, consisted of $2.5 million of interest expense and debt discount amortization related to the JGB debt, $0.4 million of interest expense and debt amortization recorded in relation to the Perceptive Credit Agreement entered into on April 17, 2018 and $0.2 million of interest expense recorded on the Allenex Notes, the Danske Bank Term Loan and the SSP Primers Loan.

The interest expense of $2.5 million in the six months ended June 30, 2017, consisted of $1.5 million of interest expense and debt discount amortization related to the JGB debt, $0.4 million of interest expense recorded in relation to deferred purchase consideration owed to the former shareholders of Allenex, $0.4 million in interest expense recorded on the Allenex Notes, the Danske Bank Term Loan and the SSP Primers Loan and $0.2 million of interest expense recorded on the East West Bank Debt.

The JGB Debt was entered into on March 15, 2017 and during the three months ended March 31, 2018 was converted into shares of our common stock. The deferred purchase consideration was related to the acquisition of Allenex and was settled in November 2017. The SSP Primers Loan was repaid in February 2018 and the Allenex Notes and Danske Bank Term Loan were repaid in April 2018. The outstanding indebtedness under the loan agreement with East West Bank was repaid in March 2017.

42


 

Other Ex pense, Net

Other expense increased by $2.0 million in the six months ended June 30, 2018 compared to 2017.  In the six months ended June 30, 2018, the other expense charge consisted of a loss of $2.8 million for the conversion of the JGB Debt in the three months ended March 31, 2018. In the six months ended June 30, 2017, the other expense charge consisted of a foreign exchange loss of $0.4 million, $0.3 million loss on early extinguishment of existing indebtedness under the Loan Agreement with East West Bank and a $0.1 million transaction settlement fee.

Change in Estimated Fair Value of Common Stock Warrant Liability and Derivative Liability

The change in estimated fair value of common stock warrant liability and derivative liability was $7.5 million expense in the six months ended June 30, 2018 and $5.2 million income in the comparative period in 2017.

The $7.5 million expense in the six months ended June 30, 2018 consisted of a $5.4 million remeasurement charge for warrants exercised during the period and a $4.6 million remeasurement charge related to the changes in fair value of our remaining common stock warrant liability. These remeasurement charges reflect the increase in the price of shares of our common stock during the six months ended June 30, 2018.  These expenses were partially offset by a $2.5 million gain recorded for the changes in fair value of the JGB debt embedded derivative between January 1, 2018 and the conversion date of March 27, 2018.

The $5.2 million income in the six months ended June 30, 2017, comprised a remeasurement gain of $3.9 million related to the changes in fair value of common stock warrant liability and a $1.3 million gain for the change in fair value of the JGB embedded derivative. These gains were primarily caused by the effect of the decrease in our stock price on the mark-to–market valuations.

As of January 1, 2018, we adopted the new accounting standard and reclassified the outstanding common stock warrant issued in connection with the JGB Debt to equity. This warrant is not re-measured through earnings after January 1, 2018. Warrants issued in connection with Private Placement and Subsequent Financing during 2016 continue to be classified as liability and will be re-measured at the end of each reporting period until expired or exercised. Changes in the common stock fair value, estimated volatility and expected contractual term will significantly impact the fair value of the warrant liability.

Income Tax Benefit

For the six months ended June 30, 2018, we recorded an income tax benefit of $0.8 million on a loss before income taxes of $23.9 million.  This benefit primarily resulted from the expectation that amortization of the various intangible assets acquired, when completed and placed in service, is not expected to be deductible for tax purposes. Accordingly, a deferred tax liability was recorded at the acquisition date for the difference between the financial reporting and tax basis of the intangibles.

Cash Flows for the Six Months Ended June 30, 2018 and 2017

The following table summarizes the primary sources and uses of cash for the periods presented:

 

 

Six Months Ended June 30,

 

 

 

2018

 

 

2017

 

 

 

(in thousands)

 

Net cash (used in) provided by:

 

 

 

 

 

 

 

 

Operating activities

 

$

(6,404

)

 

$

(9,937

)

Investing activities

 

 

(6,355

)

 

 

(94

)

Financing activities

 

 

2,758

 

 

 

11,351

 

Effect of exchange rate changes on cash, cash equivalents and restricted cash

 

 

(50

)

 

 

(64

)

Net increase (decrease) in cash, cash equivalents and restricted cash

 

$

(10,051

)

 

$

1,256

 

 

Operating Activities

Net cash used in operating activities consists of net loss, adjusted for certain noncash items in the statement of operations and changes in operating assets and liabilities. Cash used in operating activities for the six months ended June 30, 2018 was $6.4 million. Our net loss of $23.1 million was our primary use of cash in operating activities and included a number of noncash items. Our noncash items included a $7.4 million loss on the revaluation of common stock warrant and derivative liabilities to estimated fair value, a $3.2 million stock-based compensation expense, $2.8 million loss on the conversion of debt to shares of our common stock, $2.1 million amortization expense related to the JGB Debt debt discount, $2.0 million of depreciation and amortization expense, and $1.0 million contingent consideration revaluation expense.  Net operating assets decreased by $2.2 million.

43


 

 

Cash used in operating activities for the six months ended June 30, 2017 was $9.9 million. Our net loss of $9.6 million was our primary use of cash in operating activities; which also included a number of noncash items. Our noncash items included a $5.2 million gain on revaluation of warrants and derivative liabilities to estimated fair value, partially offset by $2.0 million of goodwill impairment related to our purchase of Allenex, $1.8 million of depreciation and amortization, $1.8 million of amortization of debt discount and noncash interest expense, and $0.9 million of stock-based compensation expense. Net operating assets decreased $1.4 million.

Investing Activities

For the six months ended June 30, 2018, net cash used in investing activities was $6.4 million and consisted of $5.2 million related to the acquisition of intangible assets per the Illumina License Agreement, $0.7 million for the acquisition of the Allenex AB minority interest and $0.5 million for purchases of property and equipment.

 

For the six months ended June 30, 2017, net cash used in investing activities was $0.1 million, primarily for purchases of property and equipment.

Financing Activities

Net cash provided by financing activities for the six months ended June 30, 2018 of $2.8 million was primarily related to the $14.3 million net proceeds from the Perceptive Credit Agreement and cash proceeds of $0.5 million on the exercise of warrants, partially offset by $11.3 million of principal payments of the promissory notes issued to FastPartner AB and Mohammed Al Amoudi,, Danske Term Loan, and the SSP Primers Loan, and $0.7 million repayment of the Danske Credit Facility.  

Net cash provided by financing activities for the six months ended June 30, 2017 of $11.4 million consisted primarily of $24.0 million in net proceeds received from the JGB Debt agreement in March 2017 and a $0.2 million increase in the Danske Credit Facility, partially offset by $12.9 million of principal payments on debt and capital lease obligations.

Liquidity and Capital Resources

We have incurred significant losses and negative cash flows from operations since our inception and had an accumulated deficit of $288.1 million at June 30, 2018 .  As of June 30, 2018, we had cash and cash   equivalents of $16.2  million, and $13.3  million   of debt, net of debt discount, outstanding under our long-term debt obligations.

Perceptive Credit Agreement

On April 17, 2018, we entered into a credit agreement with Perceptive for a term loan of $15.0 million and repaid the outstanding indebtedness under the Allenex Notes, and the Danske Term Loan and Credit Facility.  A second tranche of $10.0 million will be available at our option subject to the satisfaction of customary conditions.

Allenex Notes, Danske Term Loan and Danske Credit Facility

All outstanding amounts under the Allenex Notes of $4.4 million and Danske Term Loan and Credit Facility of $6.7 million were repaid on April 17, 2018.

JGB Debt

On March 1, 2018, we notified JGB of our intent to prepay on April 13, 2018, in full the outstanding principal and interest under the JGB Debentures. During the three months ended, March 31, 2018, JGB converted all outstanding $26.7 million of principal and accrued interest of the JGB Debt into an aggregate of 6,161,331 shares of our common stock.  Restricted cash of $9.4 million was released from any restrictions after the conversion and included in our cash and cash equivalent balance as of March 31, 2018.

Going Concern

We may req uire additional financing in the future to fund working capital and pay our obligations as they come due.  Additional financing might include one or more common stock offerings, debt, cash from collaboration agreements or a combination of these.  However, there can be no assurance that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable to us.  We believe our existing cash balance and expected revenues will be sufficient to meet our anticipated cash requirements for at least the next 12 months.

44


 

Factors Affecting Our Performance

The Number of AlloMap and AlloSure Tests We Receive and Report

The growth of our testing services revenue is tied to the number of AlloMap and AlloSure tests we receive and report.  Historically, less than two percent of AlloMap tests received are not reported due to improper sampling, damage in transit or other causes.  We incur costs in connection with collecting and shipping all samples and a portion of the costs when we cannot ultimately issue a test report.  As a result, the number of samples received largely correlates directly to the number of test reports.

The Number of Diagnostic Products We Sell

The growth of our product revenues is tied to the sales of the Olerup SSP, Olerup QTYPE, Olerup SBT and TruSight HLA product lines.  The product sales organizations are located in Stockholm, Sweden; Vienna, Austria; Fremantle, Australia and West Chester, Pennsylvania.  Products are sold directly to customers in 14 countries. We also use distributors to sell in approximately 60 countries.

Continued Adoption of and Reimbursement for AlloMap

AlloMap test volume and the corresponding reimbursement revenue has generally increased over time since the launch of AlloMap, as Medicare provided reimbursement and payers adopt coverage policies and fewer payers consider AlloMap to be experimental and investigational.  The rate at which our tests are covered and reimbursed has, and is expected to continue to vary by payer.  Revenue growth depends on our ability to maintain Medicare reimbursement, achieve broader reimbursement from third party payers and to expand the number of tests per patient and the base of healthcare providers.

On June 10, 2016, Centers for Medicare & Medicaid Services, or CMS, announced proposed changes in reimbursement for a number of established molecular diagnostic tests, including AlloMap.  Under the gapfill reimbursement rate for 2017, AlloMap reimbursement for patients covered by Medicare would have been reduced from $2,821 to $1,921, effective January 1, 2017.  This reimbursement rate, determined by gapfill submissions from the Medicare contractors, was open to reconsideration until October 31, 2016.  We submitted a request for reconsideration of the reimbursement rate determined by the Medicare contractors and in November 2016 CMS released the final 2017 Clinical Laboratory Fee Schedule reflecting the rate of reimbursement at $2,841 for AlloMap.

The Protecting Access to Medicare Act of 2014, or PAMA, includes a substantial new payment system for clinical laboratory tests under the CLFS. Under PAMA, laboratories that receive the majority of their Medicare revenues from payments made under the CLFS would report initially and then on a subsequent three-year basis thereafter (or annually for advanced diagnostic laboratory tests, or ADLTs), private payer payment rates and volumes for their tests.  The final PAMA ruling was issued June 17, 2016 indicating that data for reporting for the new PAMA process would begin in 2017 and the new market based rates took effect on January 1, 2018.  Effective January 1, 2018, Medicare plans to reimburse us $3,240 for AlloMap testing of Medicare beneficiaries, which represents a 14% increase over the 2017 reimbursement rate.  AlloMap has also received positive coverage decisions for reimbursement from many of the largest U.S. private payers, including Aetna, Anthem, Cigna, Health Care Services Corporation (HCSC), Humana, Kaiser Foundation Health Plan, Inc., and TRICARE.

Reimbursement for AlloSure

On September 26, 2017 we received notice that the Molecular Diagnostics Services, or MolDX, Program developed by Palmetto GBA has set AlloSure reimbursement at $2,841.   Effective October 9, 2017, AlloSure was made available for commercial testing with Medicare coverage and reimbursement. We believe the use of AlloSure, in conjunction with other clinical indicators, can help healthcare providers and their patients better manage long-term care following a kidney transplant. In particular, we believe AlloSure can improve patient care by helping healthcare providers to reduce the use of invasive biopsies and determine the appropriate dosage levels of immunosuppressants.  

Development of Additional Products and Services

We rely on sales of AlloMap, AlloSure, Olerup SSP, Olerup SBT, Olerup QTYPE and TruSight HLA to generate the majority of our revenue.  Our development pipeline includes other transplant diagnostic solutions to help clinicians and transplant centers make personalized treatment decisions throughout a transplant patient’s lifetime.  We expect to invest in research and development in order to develop additional products.  Our success in developing new products and services will be important in our efforts to grow our business by expanding the potential market for our products and diversifying our sources of revenue.

Timing of Research and Development Expenses

Our spending on experiments may vary substantially from quarter to quarter.  We also expend funds to secure clinical samples that can be used in discovery, product development, clinical validation, utility and outcome studies.  The timing of these research and development activities is difficult to predict.  If a substantial number of clinical samples are acquired in a given quarter or if a high-

45


 

cost experiment is conducted in one quarter versus the next, the timing of these expenses will affect our financial results.  We conduc t clinical studies to validate our new products, as well as on-going clinical and outcome studies to further the published evidence to support our commercialized AlloMap and AlloSure tests.  Spending on research and development for both experiments and stu dies may vary significantly by quarter depending on the timing of these various expenses.

Contractual Obligations

We are a smaller reporting company, as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and are not required to provide the information required under this item.

Off-Balance Sheet Arrangements

As of June 30, 2018, we had no off-balance sheet arrangements as defined under Regulation S-K 303(a)(4) of the Exchange Act, and the instructions thereto.

JOBS Act Accounting Election

We are an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.  Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies.  We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

Foreign Operations

The accompanying condensed consolidated balance sheets contain certain recorded assets in foreign countries, namely Stockholm, Sweden, Vienna, Austria and Fremantle, Australia.  Although these countries are considered economically stable and we have experienced no notable burden from foreign exchange transactions, export duties or government regulations, unanticipated events in foreign countries could have a material adverse effect on our operations.

 

 

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Interest Rate Risk

We are exposed to market risks in the ordinary course of our business.  We had cash and cash equivalents of $16.2 million and $16.9 million at June 30, 2018 and December 31, 2017, respectively, which consisted of bank deposits and money market funds.  Additionally, we had debt of $13.3 million and $34.1 million as of June 30, 2018 and December 31, 2017, respectively.  Such variable interest-bearing instruments carry a degree of risk.  However, we have not been exposed to, nor do we anticipate being exposed to, material risks due to changes in interest rates.  A hypothetical fifty basis point increase or decrease in interest rates would have an immaterial impact on our unaudited condensed consolidated financial statements.

Foreign Currency Exchange Risk

We have operations in Sweden, Austria, Australia and sell to other countries throughout the world.  As a result, we are subject to significant foreign currency risks, including transacting in foreign currencies, investment in a foreign entity, as well as assets and debts denominated in foreign currencies.  Our testing services revenue is primarily denominated in U.S. dollars.  Our product revenue is denominated primarily in Swedish Krona, the Euro, the Australian dollar and U.S. dollars.  Consequently, our revenue denominated in foreign currency is subject to foreign currency exchange risk.  A portion of our operating expenses are incurred outside of the U.S. and are denominated in Swedish Krona, the Euro, and the Australian Dollar, which are also subject to fluctuations due to changes in foreign currency exchange rates.  An unfavorable 10% change in foreign currency exchange rates for our assets and liabilities denominated in foreign currencies at June 30, 2018, would have negatively impacted our financial results for the six months ended June 30, 2018 by $0.2 million and our product revenue by $0.5 million.  Currently, we do not have any near-term plans to enter into a formal hedging program to mitigate the effects of foreign currency volatility.  We will continue to reassess our approach to managing our risk relating to fluctuations in foreign currency exchange rates.

 

 

ITEM 4.

CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(b) and 15d-15(e) promulgated under the Exchange Act), as of the end of the period covered by this Quarterly Report on Form 10-Q.  In designing and evaluating the disclosure controls and procedures, management

46


 

recognizes that any control s and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives.  In addition, the design of disclosure controls and procedures must reflect the fact that there are resource cons traints and that we are required to apply our judgment in evaluating the benefits of possible controls and procedures relative to our costs.  Based on such evaluation, the Chief Executive Officer and Chief Financial Officer concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective at the reasonable assurance level and are effective to provide reasonable assurance that information required to be disclosed in the reports we file and submit under the Exchange Act, is (i) recorded, processed, summarized and reported as and when required and (ii) accumulated and communicated to our management, including the Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely discussion regarding required disclosure.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the six months ended June 30, 2018 that have materially affected or are reasonably likely to materially affect, our internal control over financial reporting.

 

47


 

PART II. OTHER INFORMATION

 

ITEM 1.

LEGAL PROCEEDINGS

From time to time, we may become subject to legal proceedings and claims that arise in the ordinary course of business.  Although we do not believe that any matters presently pending will have a material adverse effect, individually or in the aggregate, on our financial position, results of operations or liquidity, legal matters and proceedings are inherently unpredictable and subject to significant uncertainties, some of which are beyond our control.  As such, there can be no assurance that the final outcome of these matters will not materially and adversely affect our financial position, results of operations or liquidity.

ITEM 1A.

RISK FACTORS

Our Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on March 22, 2018, Part I –Item 1A, Risk Factors, describes important risk factors that could cause our business, financial condition, results of operations and growth prospects to differ materially from those indicated or suggested by forward-looking statements made in this Quarterly Report on Form 10-Q or presented elsewhere by management from time to time.  There have been no material changes in the risk factors that appear in Part I - Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on March 22, 2018 other than those listed below and that the risk factor with the heading “As a result of our failure to timely file our Annual Report on Form 10-K for the year ended December 31, 2016 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, we are currently ineligible to file new short form registration statements on Form S-3, and we are unable to access our existing Registration Statement on Form S-3 for sales of securities by us, which may impair our ability to raise capital on terms favorable to us, in a timely manner or at all.” is no longer applicable to us as we regained eligibility to file new short form registration statements on Form S-3 on June 1, 2018.  Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial may also materially and adversely affect our business.

Our credit agreement contains restrictive and financial covenants that may limit our operating flexibility.

Our credit agreement with Perceptive contains certain restrictive covenants that limit our ability to merge with other companies or consummate certain changes of control, acquire other companies, make certain investments or acquisitions, pay dividends, transfer or dispose of assets, amend certain material agreements, incur additional indebtedness, permit additional liens or enter into various specified transactions.  We therefore may not be able to engage in any of the foregoing transactions unless we obtain the consent of the lender or terminate our existing debt agreement.  There is no guarantee that we will be able to generate sufficient cash flow or sales to pay the principal and interest under our debt agreement.

Refer to Note 10 of the notes to the unaudited condensed consolidated financial statements included in Part I, Item I of this Quarterly Report on Form 10-Q for details on our credit agreement with Perceptive.

Our License and Commercialization Agreement with Illumina may not result in material benefits to our business.

Pursuant to our License and Commercialization Agreement with Illumina, we acquired the worldwide distribution, development and commercialization rights to Illumina, Inc.’s next generation sequencing product line for use in the field of transplantation.

Under the License Agreement, we are obligated to complete timely development and commercialization of future products, including meeting certain commercialization milestones. The failure to meet any such milestones could result in the loss of exclusivity for the affected licensed products. Additionally, we agreed to minimum purchase commitments of finished products and raw materials from Illumina through 2023 and we are required to pay royalties in the mid-single to low-double digits on sales of future commercialized products.

We cannot make any assurances that our efforts under the License Agreement will be successful. As a result, we may not be able to fully realize the anticipated strategic benefits of the License Agreement. If we fail to successfully execute on the License Agreement, we may not realize the benefits expected from the transaction and our business may be harmed.

We do not expect to pay dividends in the foreseeable future. As a result, you must rely on stock appreciation for any return on your investment.

We do not anticipate paying cash dividends on our common stock in the foreseeable future. Any payment of cash dividends will also depend on our financial condition, results of operations, capital requirements and other factors and will be at the discretion of our board of directors. Accordingly, you will have to rely on capital appreciation, if any, to earn a return on your investment in our common stock. Furthermore, debt agreement with Perceptive prohibits us from paying dividends without the Perceptive’s prior consent, and we may in the future become subject to additional contractual restrictions on, or prohibitions against, the payment of dividends.  

48


 

 

 

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Issuer Purchases of Equity Securities

We satisfy certain U.S. federal and state tax withholding obligations due upon the vesting of restricted stock unit awards by automatically withholding from the shares being issued in connection with such award a number of shares of our common stock with an aggregate fair market value on the date of vesting equal to the minimum tax withholding obligations. The following table sets forth information with respect to shares of our common stock repurchased by us to satisfy certain tax withholding obligations during the three months ended June 30, 2018:

 

 

 

 

(a) Total Number of Shares (or Units) Purchased

 

 

(b) Average Price Paid per Share (or Unit)

 

 

 

 

April 1, 2018- April 30, 2018

 

1,444

 

(1)

$

9.45

 

 

 

 

May 1, 2018-May 31, 2018

 

 

 

 

 

 

 

 

June 1, 2018- June 30, 2018

 

45,486

 

(1)

 

12.24

 

 

 

 

Total

 

46,930

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1

)

Represents shares of our common stock withheld from employees for the payment of taxes.

 

 

 

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

None.

 

 

ITEM 5.

OTHER INFORMATION

None.

 

 

ITEM 6.

EXHIBITS

 

Exhibit

Number

 

 

 

3.1(1)

 

Amended and Restated Certificate of Incorporation.

 

 

 

3.2(2)

 

Amended and Restated Bylaws.

 

 

 

4.1(3)

 

Form of Registrant’s common stock certificate.

 

 

 

4.2(4)

 

Sixth Amended and Restated Investors Rights Agreement, dated July 1, 2009, as amended on March 29, 2012, June 10, 2014, and July 14, 2014, between the Registrant and certain holders of the Registrant’s capital stock named therein.

 

 

 

4.3(5)#

 

1998 Equity Incentive Plan and forms of agreements thereunder.

 

 

 

4.4(6)#

 

2008 Equity Incentive Plan and forms of agreement thereunder.

 

 

 

4.5(7)#

 

ImmuMetrix, Inc. 2013 Equity Plan

 

 

 

4.6(8)#

 

2014 Equity Incentive Plan, as amended.

 

 

 

4.7(9)#

 

Form of Option Agreement under the 2014 Equity Incentive Plan for New Options.

 

 

 

4.8(10)#

 

2014 Employee Stock Purchase Plan and forms of agreements thereunder.

 

 

 

4.9(11)#

 

2016 Inducement Equity Plan.

 

 

 

4.10(12)#

 

Form of Warrant.

 

 

 

4.11(13)

 

Form of Common Stock Purchase Warrant issued to the Purchasers on March 15, 2017.

49


 

 

 

 

4.12*

 

Common Stock Purchase Warrant issued to Perceptive Credit Holdings II, LP on April 17, 2018 .

 

 

 

10.1*

 

Commitment Letter dated March 1, 2018, between the Registrant and with Perceptive Credit Holdings II, LP .

 

 

 

10.2*

 

Credit Agreement and Guaranty with Perceptive Credit Holdings II, LP on April 17, 2018 .

 

 

 

10.3*

 

License and Commercialization Agreement, dated May 4, 2018, between the Registrant and Illumina, Inc.

 

 

 

31.1*

 

Certification of Periodic Report by Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

31.2*

 

Certification of Periodic Report by Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.

 

 

 

32.1**

 

Certification of Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. Section 1350 as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

 

 

101.INS*

 

XBRL Instance Document

 

 

 

101.SCH*

 

XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL*

 

XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

101.DEF*

 

XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

101.LAB*

 

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE*

 

XBRL Taxonomy Extension Presentation Linkbase Document

 

(1)

Incorporated by reference to Exhibit 3.1 to the Registrant’s Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 28, 2014.

(2)

Incorporated by reference to Exhibit 3.4 to the Registrant’s Form 10-Q filed with the SEC on August 28, 2014.

(3)

Incorporated by reference to Exhibit 4.1 to the Registrant’s Form 10-K filed with the SEC on March 31, 2015.

(4)

Incorporated by reference to Exhibit 4.2 to the Registrant’s Form 10-K filed with the SEC on March 31, 2015.

(5)

Incorporated by reference to Exhibit 10.2 to the Registrant’s Form S-1 filed with the SEC on June 3, 2014.

(6)

Incorporated by reference to Exhibit 10.3 to the Registrant’s Form S-1 filed with the SEC on June 3, 2014.

(7)

Incorporated by reference to Exhibit 10.19 to the Registrant’s Form S-1 filed with the SEC on June 3, 2014.

(8)

Incorporated by reference to Exhibit 4.4 to the Registrant’s Form S-8 filed with the SEC on July 18, 2014.

(9)

Incorporated by reference to Exhibit 99(d)(3) to the Registrant’s Form SC TO-I filed with the SEC on October 12, 2017.

(10)

Incorporated by reference to Exhibit 4.5 to the Registrant’s Form S-8 filed with the SEC on July 18, 2014.

(11)

Incorporated by reference to Exhibit 4.1 to the Registrant’s Form S-8 filed with the SEC on May 23, 2016.

(12)

Incorporated by reference to Exhibit 10.3 to the Registrant’s Form 8-K filed with the SEC on April 14, 2016.

(13)

Incorporated by reference to Exhibit 4.2 to the Registrant’s Form 8-K filed with the SEC on March 15, 2017.

 

 

 

#

Indicates management contract or compensatory plan or arrangement.

*

Filed herewith.

**

Furnished herewith.

The Registrant has requested confidential treatment with respect to certain portions of the exhibit. Omitted portions have been filed separately with the SEC.

 

50


 

SIGNATURES

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.

 

 

 

 CAREDX, INC.

 

 

 (Registrant)

 

 

 

Date: August 9, 2018

 

By:

 

/s/ PETER MAAG

 

 

 

 

Peter Maag

 

 

 

 

President and Chief Executive Officer

 

 

 

 

(Principal Executive Officer)

 

 

 

 

 

By:

 

/s/ MICHAEL BELL

 

 

 

 

Michael Bell

 

 

 

 

Chief Financial Officer

 

 

 

 

(Principal Accounting and Financial Officer)

 

 

51

Exhibit 4.12

Execution Version

 

NEITHER THIS SECURITY NOR THE SECURITIES FOR WHICH THIS SECURITY IS EXERCISABLE HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS AS MAY BE REQUIRED TO BE EVIDENCED BY A LEGAL OPINION OF COUNSEL TO THE TRANSFEROR TO SUCH EFFECT, THE SUBSTANCE OF WHICH SHALL BE REASONABLY ACCEPTABLE TO THE COMPANY.  THIS SECURITY AND THE SECURITIES ISSUABLE UPON EXERCISE OF THIS SECURITY MAY BE PLEDGED IN CONNECTION WITH A BONA FIDE MARGIN ACCOUNT WITH A REGISTERED BROKER-DEALER OR OTHER LOAN WITH A FINANCIAL INSTITUTION THAT IS AN “ACCREDITED INVESTOR” AS DEFINED IN RULE 501(a) UNDER THE SECURITIES ACT.

 

COMMON STOCK PURCHASE WARRANT

 

CAREDX, inc.

Common Stock Warrant Shares: 140,000                                            Dated:   April 17, 2018

 

THIS COMMON STOCK PURCHASE WARRANT (this “ Warrant ”) certifies that, for value received, Perceptive Credit Holdings II, LP or its assigns (the “ Holder ”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after  October 17, 2018 (the “ Initial Exercise Date ”), and on or prior to the close of business on April 17, 2025 (the “ Expiration Date ”) but not thereafter, to subscribe for and purchase from CareDx, Inc., a Delaware corporation (the “ Company ”), up to one hundred forty thousand (140,000) shares (as subject to adjustment hereunder, the “ Warrant Shares ”) of Common Stock.  The purchase price of one share of Common Stock under this Warrant shall be equal to the Exercise Price, as defined in Section 2(b) .  

This Warrant is issued pursuant to that certain Credit Agreement and Guaranty dated as of April 17, 2018 (the “ Credit Agreement ”) by and among the Company, as borrower, the subsidiaries of the Company from time to time party thereto as guarantors, the lenders from time to time party thereto, and Holder, as administrative agent for the lenders.

Section 1 . Definitions .  For the purposes hereof, in addition to the terms defined elsewhere in this Warrant, (a) capitalized terms used and not otherwise defined herein shall have the meanings set forth in the Credit Agreement, and (b) the following terms shall have the following meanings:

 


 

Affiliate ” means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person, as such terms are used in and construed under Rule 405 under the Securities Act.

Closing Bid Price ” means for any date, the price determined by the first of the following clauses that applies: (a) if the Common Stock is then listed or quoted on a Trading Market, the last reported closing bid price for Common Stock for such date (or the nearest preceding date) on the Trading Market on which the Common Stock is then listed or quoted as reported by Bloomberg, L.P., (b) if the Common Stock is not then listed or quoted for trading on a Trading Market and if prices for the Common Stock are then reported in the “Pink Sheets” published by OTC Markets Group, Inc. (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Common Stock so reported, or (c) in all other cases, the fair market value of a share of Common Stock as determined by an independent appraiser selected in good faith by the Holder and reasonably acceptable to the Company, the reasonable, actual and documented fees and reasonable, actual and documented out-of-pocket expenses of which shall be paid by the Company.

Commission ” means the United States Securities and Exchange Commission.

Common Stock ” means the common stock of the Company, par value $0.001 per share, and any other class of securities into which such securities may hereafter be reclassified or changed.

Common Stock Equivalents ” means any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire at any time Common Stock, including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.

Exempt Issuance ” means the issuance of (a) shares of Common Stock or Common Stock Equivalents to employees, officers or directors of the Company pursuant to any stock or option plan duly adopted for such purpose by a majority of the Board or the compensation committee thereof and the issuance of Common Stock in respect thereof, (b) warrants issued pursuant to the Credit Agreement and/or other securities exercisable or exchangeable for or convertible into shares of Common Stock issued and outstanding on the date of this Warrant, provided that such securities have not been amended since the date of this Warrant to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities (for purposes of clarity, any decrease in the exercise price, exchange price or conversion price of such securities shall not be deemed an amendment thereto, if such decrease is as a result of any price-based anti-dilution provision contained in such securities prior to the date hereof) and (c) securities issued pursuant to acquisitions, joint ventures, partnerships or strategic transactions approved by a majority of the disinterested directors of the Company, provided that any such issuance shall only be to a Person (or to the equityholders of a Person) which, as determined in good faith by the Company’s Board, is, itself or through its subsidiaries, an operating company or an owner of an asset in a business similar to or synergistic with the business of the Company and shall provide to the Company additional benefits in addition to the investment of funds, but

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shall not include a transaction in which the Compan y is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities.

Fundamental Transaction ” means (a) the Company, directly or indirectly, in one or more related transactions effects any merger or consolidation of the Company with or into another Person, (b) the Company, directly or indirectly, effects any sale, lease, exclusive license, assignment, transfer, conveyance or other disposition of all or substantially all of its assets in one or a series of related transactions, (c) any, direct or indirect, purchase offer, tender offer or exchange offer (whether by the Company or another Person) is completed pursuant to which holders of Common Stock are permitted to sell, tender or exchange their shares for other securities, cash or property and has been accepted by the holders of fifty percent (50%) or more of the outstanding Common Stock, (d) the Company, directly or indirectly, in one or more related transactions effects any reclassification, reorganization or recapitalization of the Common Stock (but, for the avoidance of doubt, excluding any transaction, event or occurrence covered by Section 3(a) ) or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property, (e) the Company, directly or indirectly, in one or more related transactions consummates a stock or share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off or scheme of arrangement) with another Person whereby such other Person acquires more than fifty percent (50%) of the outstanding shares of Common Stock (not including any shares of Common Stock held by the other Person or other Persons making or party to, or associated or Affiliated with the other Persons making or party to, such stock or share purchase agreement or other business combination).

Registration Statement ” means any one or more registration statements of the Company filed under the Securities Act that covers the resale of any of the Warrant Shares.

Rule 144 ” means Rule 144 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same effect as such Rule.

Subsidiary ” means any subsidiary of the Company existing on the date hereof and any subsidiary of the Company formed or acquired after the date hereof.

Trading Day ” means a day on which the principal Trading Market is open for trading.

Trading Market ” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date in question: the NYSE MKT, the Nasdaq Global Market, the Nasdaq Capital Market, the New York Stock Exchange, the OTCQB, the OTCQX U.S. or the Nasdaq Global Select Market (or any successors to any of the foregoing).

Transfer Agent ” means Computershare Trust Company, N.A., the current transfer agent of the Company, with a mailing address of 520 Pike Street, Suite 1220, Seattle, WA 98101, and any successor transfer agent of the Company.

VWAP ” means, for any date, the price determined by the first of the following clauses that applies: (a) if the Common Stock is then listed or quoted on a Trading Market, the daily

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volume weighted average price of the Common Stock for such date (or the nearest preceding date) on the Trading Market on which the Common Stock is then listed or quoted as reported by Bloomberg, L.P. (based on a Trading Day from 9:30 a.m. (local time in New York City, New York) to 4:00 p.m. (local time in New York City, New York)) (b) if the Common Stock is not then listed or quoted for trading on a Trading Market and if prices for the Common Stoc k are then reported in the “Pink Sheets” published by OTC Markets Group, Inc. (or a similar organization or agency succeeding to its functions of reporting prices), the most recent bid price per share of the Common Stock so reported, or (c) in all other ca ses, the fair market value of a share of Common Stock as determined by an independent appraiser selected in good faith by the Holder and reasonably acceptable to the Company, the reasonable, actual and documented fees and reasonable, actual and documented out-of-pocket expenses of which shall be paid by the Company.

Section 2 . Exercise .

a) Exercise of Warrant .  Exercise of the purchase rights represented by this Warrant may be made, in whole or in part, at any time or times on or after the Initial Exercise Date and on or before the Expiration Date by delivery to the Company (or such other office or agency of the Company as it may designate by notice in writing to the registered Holder at the address of the Holder appearing on the books of the Company) of a duly executed facsimile copy of the Notice of Exercise in the form annexed hereto (the “ Notice of Exercise ”) and within three (3) Trading Days of the date said Notice of Exercise is delivered to the Company, the Company shall have received payment of the aggregate Exercise Price of the shares thereby purchased by wire transfer or cashier’s check drawn on a United States bank or, if available, pursuant to the cashless exercise procedure specified in Section 2(c) below. No ink-original Notice of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise form be required.  Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Company until the Holder has purchased all of the Warrant Shares available hereunder and this Warrant has been exercised in full, in which case, the Holder shall surrender this Warrant to the Company for cancellation within three (3) Trading Days of the date the final Notice of Exercise is delivered to the Company. Partial exercises of this Warrant resulting in purchases of a portion of the total number of Warrant Shares available hereunder shall have the effect of lowering the outstanding number of Warrant Shares purchasable hereunder in an amount equal to the applicable number of Warrant Shares purchased.  The Holder and the Company shall maintain records showing the number of Warrant Shares purchased and the date of such purchases. The Company shall deliver any objection to any Notice of Exercise within two (2) Trading Days of receipt of such notice.   The Holder and any assignee, by acceptance of this Warrant, acknowledge and agree that, by reason of the provisions of this paragraph, following the purchase of a portion of the Warrant Shares hereunder, the number of Warrant Shares available for purchase hereunder at any given time may be less than the amount stated on the face hereof.

In the event that immediately prior to the close of business on the Expiration Date, the Closing Bid Price of one share of Common Stock is greater than the then

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applicable Exercise Price, this Warrant shall be deemed to be automatically exercised as a “cashless exercise” pursuant to Section 2(c) below, and the Company shall deliver the applicable number of shares of Common Stock to the Holder pursuant to the provisions of Section 2(d) below.

b) Exercise Price .  The exercise price per share of the Common Stock under this Warrant shall be $8.60, subject to adjustment hereunder (the “ Exercise Price ”).

c) Cashless Exercise .  If at any time after the Initial Exercise Date, there is no effective Registration Statement registering, or no current prospectus available for, the resale of the Warrant Shares by the Holder, then this Warrant may also be exercised, in whole or in part, at any time by means of a “cashless exercise” in which the Holder shall be entitled to receive a number of Warrant Shares equal to the quotient obtained by dividing [(A-B) (X)] by (A), where:

(A) = the VWAP on the Trading Day immediately preceding the date on which Holder elects to exercise this Warrant by means of a “cashless exercise,” as set forth in the applicable Notice of Exercise;

 

(B) = the Exercise Price of this Warrant, as adjusted hereunder; and

 

(X) = the number of Warrant Shares that would be issuable upon exercise of this Warrant in accordance with the terms of this Warrant if such exercise were by means of a cash exercise rather than a cashless exercise.

 

 

d)

Mechanics of Exercise .

i. Delivery of Warrant Shares Upon Exercise .  Warrant Shares purchased hereunder shall be transmitted by the Transfer Agent to the Holder by crediting the account of the Holder’s prime broker with The Depository Trust Company through its Deposit or Withdrawal at Custodian system (“ DWAC ”) if the Company is then a participant in such system and either (A) there is an effective Registration Statement permitting the issuance of the Warrant Shares to or resale of the Warrant Shares by the Holder or (B) the shares are eligible for resale by the Holder without volume or manner-of-sale limitations pursuant to Rule 144, and otherwise by physical delivery to the address specified by the Holder in the Notice of Exercise by the date that is two (2) Trading Days after the delivery to the Company of the Notice of Exercise and payment of the aggregate Exercise Price as set forth above (including by cashless exercise, if permitted) (such date, the “ Warrant Share Delivery Date ”).   The Warrant Shares shall be deemed to have been issued, and the Holder or any other person so designated to be named therein shall be deemed to have become a holder of record of such shares for all purposes, as of the date this Warrant has been exercised, with payment to the Company of the Exercise Price (or by cashless exercise, if permitted) and all taxes required to be paid by the Holder, if any, pursuant to Section 2(d)(v)

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prior to the issuance of such shares, having been paid.  If the Company fails for any reason to deliver to the Holder the Warrant Shares subject to a Notice of Exercise by the Warrant Share Delivery Date, other than a failure to deliver caused by the Holder’s failure to pay the applicable Exercise Price for such Warrant Shares, the Company shall pay to the Holder, in cash, as liquidated damages and no t as a penalty, for each $1,000 of Warrant Shares subject to such exercise (based on the VWAP of the Common Stock on the date of the applicable Notice of Exercise), $8.60 per Trading Day for each Trading Day after such Warrant Share Delivery Date until suc h Warrant Shares are delivered or Holder rescinds such exercise.

ii. Delivery of New Warrants Upon Exercise .  If this Warrant shall have been exercised in part, the Company shall, at the request of a Holder and upon surrender of this Warrant certificate, at the time of delivery of the Warrant Shares, deliver to the Holder a new Warrant evidencing the rights of the Holder to purchase the unpurchased Warrant Shares called for by this Warrant, which new Warrant shall in all other respects be identical with this Warrant.

iii. Rescission Rights .  If the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares pursuant to Section 2(d)(i) by the third (3 rd ) Trading Day following the Warrant Share Delivery Date, then the Holder will have the right to rescind such exercise.

iv. Compensation for Buy-In on Failure to Timely Deliver Warrant Shares Upon Exercise .  In addition to any other rights available to the Holder, if the Company fails to cause the Transfer Agent to transmit to the Holder the Warrant Shares pursuant to an exercise on or before the second (2 nd ) Trading Day following the Warrant Share Delivery Date, and if after such date the Holder is required by its broker to purchase (in an open market transaction or otherwise) or the Holder’s brokerage firm otherwise purchases, shares of Common Stock to deliver in satisfaction of a sale by the Holder of the Warrant Shares which the Holder anticipated receiving upon such exercise (a “ Buy-In ”), then the Company shall (A) pay in cash to the Holder the amount, if any, by which (x) the Holder’s total purchase price (including brokerage commissions, if any) for the shares of Common Stock so purchased (provided, Holder exercises reasonable efforts to minimize the amount of such purchase price) exceeds (y) the amount obtained by multiplying (1) the number of Warrant Shares that the Company was required to deliver to the Holder in connection with the exercise at issue by (2) the actual sale price at which the sell order giving rise to such purchase obligation was executed, and (B) at the option of the Holder, either reinstate the portion of the Warrant and equivalent number of Warrant Shares for which such exercise was not honored (in which case such

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exercise shall be deemed rescinded) or deliver to the H older the number of shares of Common Stock that would have been issued had the Company timely complied with its exercise and delivery obligations hereunder.  For example, if the Holder purchases Common Stock having a total purchase price of $11,000 to cove r a Buy-In with respect to an attempted exercise of shares of Common Stock with an aggregate sale price giving rise to such purchase obligation of $10,000, under clause (A) of the immediately preceding sentence the Company shall be required to pay the Hold er $1,000. The Holder shall provide the Company written notice indicating the amounts payable to the Holder in respect of the Buy-In and, upon request of the Company, evidence of the amount of such loss.  Nothing herein shall limit a Holder’s right to purs ue any other remedies available to it hereunder, at law or in equity, including, without limitation, a decree of specific performance and/or injunctive relief with respect to the Company’s failure to timely deliver shares of Common Stock upon exercise of t he Warrant as required pursuant to the terms hereof.

v. No Fractional Shares or Scrip .  No fractional shares or scrip representing fractional shares shall be issued upon the exercise of this Warrant.  As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such exercise, the Company shall, at its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Exercise Price or round up to the next whole share.

vi. Charges, Taxes and Expenses .  Issuance of Warrant Shares shall be made without charge to the Holder for any issue or transfer tax or other incidental expense in respect of the issuance of Warrant Shares, all of which taxes and expenses shall be paid by the Company, and such Warrant Shares shall be issued in the name of the Holder or in such name or names as may be directed by the Holder; provided , however , that in the event that Warrant Shares are to be issued in a name other than the name of the Holder, this Warrant when surrendered for exercise shall be accompanied by a completed Assignment Form in the form attached hereto duly executed by the Holder and the Company may require, as a condition thereto, the payment of a sum sufficient to reimburse it for any transfer tax incidental thereto.  The Company shall pay all Transfer Agent fees required for same-day processing of any Notice of Exercise and all fees to the Depository Trust Company (or another established clearing corporation performing similar functions) required for same-day electronic delivery of the Warrant Shares.

vii. Closing of Books .  The Company will not close its stockholder books or records in any manner which prevents the timely exercise of this Warrant, pursuant to the terms hereof.

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e) Holder’s E xercise Limitations .  The Company shall not effect any exercise of this Warrant, and a Holder shall not have the right to exercise any portion of this Warrant, pursuant to this Section 2 or otherwise, to the extent that after giving effect to such issuance after exercise as set forth on the applicable Notice of Exercise, the Holder (together with the Holder’s Affiliates, and any other Persons acting as a group together with the Holder or any of the Holder’s Affiliates), would beneficially own in excess of t he Beneficial Ownership Limitation (as defined below).  For purposes of the foregoing sentence, the number of shares of Common Stock beneficially owned by the Holder and its Affiliates shall include the number of shares of Common Stock issuable upon exerci se of this Warrant with respect to which such determination is being made, but shall exclude the number of shares of Common Stock which would be issuable upon (i) exercise of the remaining, nonexercised portion of this Warrant beneficially owned by the Hol der or any of its Affiliates, and (ii) exercise or conversion of the unexercised or nonconverted portion of any other securities of the Company (including, without limitation, any other Common Stock Equivalents) subject to a limitation on conversion or exe rcise analogous to the limitation contained herein beneficially owned by the Holder or any of its Affiliates.  Except as set forth in the preceding sentence, for purposes of this Section 2(e ), beneficial ownership shall be calculated in accordance with Sec tion 13(d) of the Exchange Act and the rules and regulations promulgated thereunder, it being acknowledged by the Holder that the Company is not representing to the Holder that such calculation is in compliance with Section 13(d) of the Exchange Act and th e Holder is solely responsible for any schedules required to be filed in accordance therewith.  To the extent that the limitation contained in this Section 2(e) applies, the determination of whether this Warrant is exercisable (in relation to other securit ies owned by the Holder together with any Affiliates) and of which portion of this Warrant is exercisable shall be in the sole discretion of the Holder, and the submission of a Notice of Exercise shall be deemed to be the Holder’s determination of whether this Warrant is exercisable (in relation to other securities owned by the Holder together with any Affiliates) and of which portion of this Warrant is exercisable, in each case subject to the Beneficial Ownership Limitation, and the Company shall have no o bligation to verify or confirm the accuracy of such determination.  In addition, a determination as to any group status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder.  For purposes of this Section 2(e) , in determining the number of outstanding shares of Common Stock, a Holder may rely on the number of outstanding shares of Common Stock as reflected in (A) the Company’s most recent periodic or annual report filed with the Commission, as the case may be, (B) a more recent public announcement by the Company, or (C) a more recent written notice from the Company or the Transfer Agent setting forth the number of shares of Common Stock outstanding.  Upon the writte n request of a Holder, the Company shall within three (3) Trading Days confirm orally and in writing to the Holder the number of shares of Common Stock then outstanding.  In any case, the number of outstanding shares of Common Stock shall be determined aft er giving effect to the conversion or exercise of securities of the Company, including this Warrant, by the Holder or its Affiliates since the date as of which such number of outstanding shares of Common Stock was reported.  The “ Beneficial Ownership Limit ation ” shall be 9.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the applicable issuance of shares of Common Stock issuable upon exercise of this Warrant.  The provisions of this paragraph shall be construed and implemented in a manner otherwise than in strict conformity with the terms of this Section 2(e) to correct this paragraph (or any portion hereof) which may be defective or inconsistent with the intended Beneficial Ownership Limitation herein contained or to make changes or supplements necessary or desirable to properly give effect to such limitation. The limitations contained in this paragraph shall apply to a successor holder of this Warrant.

Section 3 . Certain Adjustments .

a) Stock Dividends and Splits . If the Company, at any time while this Warrant is outstanding: (i) pays a stock dividend or otherwise makes a distribution or distributions on shares of its Common Stock or any Common Stock Equivalents (which, for avoidance of doubt, shall not include any shares of Common Stock issued by the Company upon exercise of this Warrant), (ii) subdivides outstanding shares of Common Stock into a larger number of shares, (iii) combines (including by way of reverse stock split) outstanding shares of Common Stock into a smaller number of shares, or (iv) issues by reclassification of shares of the Common Stock any shares of capital stock of the Company, then in each case, the Exercise Price shall be multiplied by a fraction of which the numerator shall be the number of shares of Common Stock (excluding treasury shares, if any) outstanding immediately before such event and of which the denominator shall be the number of shares of Common Stock outstanding immediately after such event, and the number of shares issuable upon exercise of this Warrant shall be proportionately adjusted such that the aggregate Exercise Price of this Warrant shall remain unchanged.  Any adjustment made pursuant to this Section 3(a) shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision, combination or reclassification.

b) Subsequent Equity Sales . If the Company, at any time while this Warrant is outstanding, shall sell or grant any option to purchase, or sell or grant any right to re-price, or otherwise dispose of or issue (or announce any offer, sale, grant or any option to purchase or other disposition) any Common Stock or Common Stock Equivalents, at an effective price per share less than the Exercise Price then in effect (such issuances collectively, a “ Dilutive Issuance ”) (it being understood and agreed that if the holder of the Common Stock or Common Stock Equivalents so issued shall at any time, whether by operation of purchase price adjustments, reset provisions, floating conversion, exercise or exchange prices or otherwise, or due to warrants, options or rights per share which are issued in connection with such issuance, be entitled to receive shares of Common Stock at an effective price per share that is less than the Exercise Price, such issuance shall be deemed to have occurred for less than the Exercise Price on such date of the Dilutive

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Issuance at such effect ive price), then, simultaneously with the consummation of each Dilutive Issuance, the Exercise Price shall be reduced and only reduced to an amount equal to the product obtained by multiplying the Exercise Price by a fraction, the numerator of which is the number of shares of Common Stock issued and outstanding immediately prior to the Dilutive Issuance plus the number of shares of Common Stock which the aggregate offering price for such Dilutive Issuance would purchase at the then Exercise Price, and the d enominator of which shall be the sum of the number of shares of Common Stock issued and outstanding immediately prior to the Dilutive Issuance plus the number of shares of Common Stock so issued or issuable in connection with the Dilutive Issuance (such pr oduct, the “ Base Exercise Price ”), and the number of Warrant Shares issuable upon exercise of this Warrant shall be proportionately adjusted such that the aggregate Exercise Price of this Warrant shall remain unchanged.  Notwithstanding the foregoing, no a djustments shall be made, paid or issued under this Section 3(b) in respect of an Exempt Issuance.  The Company shall notify the Holder, in writing, no later than two (2) Trading Days following the issuance or deemed issuance of any Common Stock or Common Stock Equivalents subject to this Section 3(b) , indicating therein the applicable issuance price, or applicable reset price, exchange price, conversion price and other pricing terms (such notice, the “ Dilutive Issuance Notice ”).  For purposes of clarificat ion, whether or not the Company provides a Dilutive Issuance Notice pursuant to this Section 3(b) , upon the occurrence of any Dilutive Issuance, the Holder is entitled to receive a number of Warrant Shares based upon the Base Exercise Price on or after the date of such Dilutive Issuance, regardless of whether the Holder accurately refers to the Base Exercise Price in the Notice of Exercise.

c) Fundamental Transaction . If, at any time while this Warrant is outstanding, the Company effects a Fundamental Transaction, then, upon any subsequent exercise of this Warrant, the Holder shall have the right to receive, for each Warrant Share that would have been issuable upon such exercise immediately prior to the occurrence of such Fundamental Transaction, at the option of the Holder (without regard to any limitation in Section 2(e) on the exercise of this Warrant), the number of shares of Common Stock of the successor or acquiring corporation or of the Company, if it is the surviving corporation, and any additional consideration (the “ Alternate Consideration ”) receivable as a result of such Fundamental Transaction by a holder of the number of shares of Common Stock for which this Warrant is exercisable immediately prior to such Fundamental Transaction (without regard to any limitation in Section 2(e) on the exercise of this Warrant).  For purposes of any such exercise, the determination of the Exercise Price shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one (1) share of Common Stock in such Fundamental Transaction, and the Company shall apportion the Exercise Price among the Alternate Consideration in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration.  If holders of Common Stock are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holder shall be given the same choice as to the Alternate Consideration it receives upon any exercise of this Warrant following such Fundamental Transaction.  The Company shall cause any successor entity in a Fundamental Transaction in which the Company is not the survivor (the “ Successor Entity ”) to assume in writing all of the obligations of the Company under this Warrant in

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accordance with the provisions of this Section 3(c) pursuant to written agreements in form and substance reasonably satisfactory to the Holder and approved by the Holder (without unreasonable delay) prior to such F undamental Transaction and shall, at the option of the Holder, deliver to the Holder in exchange for this Warrant a security of the Successor Entity evidenced by a written instrument substantially similar in form and substance to this Warrant which is exer cisable for a corresponding number of shares of capital stock of such Successor Entity (or its parent entity) equivalent to the shares of Common Stock acquirable and receivable upon exercise of this Warrant (without regard to any limitations on the exercis e of this Warrant) prior to such Fundamental Transaction, and with an exercise price which applies the Exercise Price hereunder to such shares of capital stock (but taking into account the relative value of the shares of Common Stock pursuant to such Funda mental Transaction and the value of such shares of capital stock, such number of shares of capital stock and such Exercise Price being for the purpose of protecting the economic value of this Warrant immediately prior to the consummation of such Fundamenta l Transaction), and which is reasonably satisfactory in form and substance to the Holder. Upon the occurrence of any such Fundamental Transaction, the Successor Entity shall succeed to, and be substituted for (so that from and after the date of such Fundam ental Transaction, the provisions of this Warrant and the other Loan Documents referring to the “Company” shall refer instead to the Successor Entity), and may exercise every right and power of the Company and shall assume all of the obligations of the Com pany under this Warrant and the other Loan Documents with the same effect as if such Successor Entity had been named as the Company herein.

d) Calculations . All calculations under this Section 3 shall be made to the nearest cent or the nearest 1/100th of a share, as the case may be. For purposes of this Section 3 , the number of shares of Common Stock deemed to be issued and outstanding as of a given date shall be the sum of the number of shares of Common Stock (excluding treasury shares, if any) issued and outstanding.

e) Notice to Holder .  

i. Adjustment to Exercise Price . Whenever the Exercise Price is adjusted pursuant to any provision of this Section 3 , the Company shall, upon written request of the Holder, promptly deliver to the Holder a notice setting forth the Exercise Price after such adjustment and any resulting adjustment to the number of Warrant Shares and setting forth a brief statement of the facts requiring such adjustment.

ii. Notice to Allow Exercise by Holder . If (A) the Company shall declare a dividend (or any other distribution in whatever form) on the Common Stock, (B) the Company shall declare a special nonrecurring cash dividend on or a redemption of the Common Stock, (C) the Company shall authorize the granting to all holders of the Common Stock rights or warrants to subscribe for or purchase any shares of capital stock of any class or of any rights, (D) the approval of any stockholders of the Company shall be required in connection with any reclassification of the Common Stock, any consolidation or merger to which the Company is a

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party, any sale or transfer of all or substantially all of the assets of the Company, or any compulsory share exchange whereby the Common Stock is converted into other securities, cash or property, (E) the Company shall au thorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Company, or (F) the Company seeks to engage in a Fundamental Transaction, then, in each case, the Company shall cause to be mailed to the Holder at its last a ddress as it shall appear upon the Warrant Register (as defined below) of the Company, at least twenty (20) calendar days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Common Stock of record to be entitled to such dividend, distributions, redemption, rights or warrant s are to be determined or (y) the date on which such Fundamental Transaction, reclassification, consolidation, merger, sale, transfer or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Co mmon Stock of record shall be entitled to exchange their shares of the Common Stock for securities, cash or other property deliverable upon such Fundamental Transaction, reclassification, consolidation, merger, sale, transfer or share exchange; provided th at the failure to mail such notice or any defect therein or in the mailing thereof shall not affect the validity of the corporate action required to be specified in such notice. To the extent that any notice required to be provided hereunder may contain in formation that constitutes material, non-public information regarding the Company or any of the Subsidiaries, the Company shall obtain the Holder’s prior consent to receipt of such notice. If the Holder declines to receive any such notice pursuant to the i mmediately preceding sentence, the Company shall not be deemed to have breached its obligation to deliver such notice hereunder.  The Holder shall remain entitled to exercise this Warrant during the 20-day period commencing on the date of such notice throu gh the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.

Section 4 . Transfer of Warrant .

a) Transferability .  Subject to compliance with any applicable securities laws and the conditions set forth in Section 4(d) hereof, this Warrant and all rights hereunder (including, without limitation, any registration rights) are transferable, in whole or in part, upon surrender of this Warrant at the principal office of the Company or its designated agent, together with a written assignment of this Warrant substantially in the form attached hereto duly executed by the Holder or its agent or attorney and funds sufficient to pay any transfer taxes payable upon the making of such transfer.  Upon such surrender and, if required, such payment, the Company shall execute and deliver a new Warrant or Warrants in the name of the assignee or assignees, as applicable, and in the denomination or denominations specified in such instrument of assignment, and shall issue to the assignor a new Warrant evidencing the portion of this Warrant not so assigned, and this

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Warrant shall promptly be cancelled. Notwithstanding anything herein to the contrary, the Holder shall not be required to physically surrender this Warrant to the Compan y unless the Holder has assigned this Warrant in full, in which case, the Holder shall surrender this Warrant to the Company within two (2) Trading Days of the date the Holder delivers to the Company a completed Assignment Form in the form attached hereto duly executed by the Holder assigning all or any portion of this Warrant.  This Warrant, if properly assigned in accordance herewith, may be exercised by a new holder for the purchase of Warrant Shares without having a new Warrant issued.  

b) New Warrants . This Warrant may be divided or combined with other Warrants upon presentation hereof at the aforesaid office of the Company, together with a written notice specifying the names and denominations in which new Warrants are to be issued, signed by the Holder or its agent or attorney.  Subject to compliance with Section 4(a) , as to any transfer which may be involved in such division or combination, the Company shall execute and deliver a new Warrant or Warrants in exchange for the Warrant or Warrants to be divided or combined in accordance with such notice. All Warrants issued on transfers or exchanges shall be dated the Initial Exercise Date and shall be identical with this Warrant except as to the number of Warrant Shares issuable pursuant thereto.

c) Warrant Register . The Company shall register this Warrant, upon records to be maintained by the Company for that purpose (the “ Warrant Register ”), in the name of the record Holder hereof from time to time.  The Company may deem and treat the registered Holder of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other purposes, absent actual notice to the contrary.

d) Transfer Restrictions . If, at the time of the surrender of this Warrant in connection with any transfer of this Warrant , the transfer of this Warrant shall not be either (i) registered pursuant to an effective Registration Statement and under applicable state securities or blue sky laws, or (ii) eligible for resale without volume or manner-of-sale restrictions or current public information requirements pursuant to Rule 144, the Company may require, as a condition of allowing such transfer, that the Holder or transferee of this Warrant , as the case may be, deliver, (x) if reasonably requested by the Company, an opinion of counsel reasonably satisfactory to the Company to the effect that the transfer of such portion of this Warrant may be made pursuant to an available exemption from the registration requirements of the Securities Act; provided that  such opinion shall not be required in connection with any transfer (i) to the Company or to an Affiliate of the Holder or (ii) in connection with a bona fide pledge and (y) a written statement from the transferee to the Company certifying that the transferee is an “accredited investor” as defined in Rule 501(a) under the Securities Act and making the representations and certifications set forth in  Section 4(e) of this Warrant.

e) Representation by the Holder .  The Holder, by the acceptance hereof, represents and warrants that it is acquiring this Warrant and, upon any exercise hereof, will acquire the Warrant Shares issuable upon such exercise, for its own account and not with a view to or for distributing or reselling such Warrant Shares or any part thereof in

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violation of the Securities Act or any applicable state securities law, except pursuant to sales registered or exempted under the Securities Act.

Section 5 . Miscellaneous .

a) No Rights as Stockholder Until Exercise .  This Warrant does not entitle the Holder to any voting rights, dividends or other rights as a stockholder of the Company prior to the exercise hereof as set forth in Section 2(d)(i) , except as expressly set forth in Section 3 .  

b) Loss, Theft, Destruction or Mutilation of Warrant . The Company covenants that upon receipt by the Company of evidence reasonably satisfactory to it of the loss, theft, destruction or mutilation of this Warrant or any stock certificate relating to the Warrant Shares, and in case of loss, theft or destruction, of indemnity or security reasonably satisfactory to it (which, in the case of this Warrant, shall not include the posting of any bond), and upon surrender and cancellation of such Warrant or stock certificate, if mutilated, the Company will make and deliver a new Warrant or stock certificate of like tenor and dated as of such cancellation, in lieu of such Warrant or stock certificate.

c) Removal of Restrictive Legends .  Neither this Warrant nor any certificates evidencing Warrant Shares shall contain any legend restricting the transfer thereof in any of the following circumstances: (A) following any sale of this Warrant or any Warrant Shares issued or delivered to the Holder under or in connection herewith pursuant to Rule 144 or pursuant to a Registration Statement covering the sale or resale of the Warrant Shares, (B) if this Warrant or the Warrant Shares are eligible for sale under Rule 144(b)(1), or (C) if such legend is not required under applicable requirements of the Securities Act (including judicial interpretations and pronouncements issued by the staff of the Commission) (collectively, the “ Unrestricted Conditions ”).  If the Unrestricted Conditions are met at the time of issuance of this Warrant or the Warrant Shares, then this Warrant or the Warrant Shares, as the case may be, shall be issued free of all legends.

d) Sale of Unlegended Shares .  The Holder agrees that the removal of the restrictive legend from this Warrant and any certificates representing securities as set forth in Section 5(c) above is predicated upon the Company’s reliance that the Holder will sell this Warrant or any such securities pursuant to either an effective Registration Statement or otherwise pursuant to the requirements of the Securities Act, including any applicable prospectus delivery requirements, or an exemption therefrom, and that if such securities are sold pursuant to a Registration Statement, they will be sold in compliance with the plan of distribution set forth therein.

e) Authorized Shares .  The Company covenants that, during the period this Warrant is outstanding, it will reserve from its authorized and unissued Common Stock a sufficient number of shares to provide for the issuance of the Warrant Shares upon the exercise of any purchase rights under this Warrant.  The Company further covenants that its issuance of this Warrant shall constitute full authority to its officers who are charged with the duty of issuing the necessary Warrant Shares upon the exercise of the purchase

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rights under this Warrant.  The Company will take all such reasonable action as may be necessary to assure that such Warrant Shares may be issued as provided herein without violation of any applicable law or regulation, or of any requirements of the Trading Market upon which the Common Stock may be listed .  The Company covenants that all Warrant Shares which may be issued upon the exercise of the purchase rights represented by this Warrant will, upon exercise of the purchase rights represented by this Warrant and payment for such Warrant Shares in accordan ce herewith, be duly authorized, validly issued, fully paid and nonassessable and free from all taxes, liens and charges created by the Company in respect of the issue thereof (other than taxes in respect of any transfer occurring contemporaneously with su ch issue).

Except and to the extent as waived or consented to by the Holder, the Company shall not by any action, including, without limitation, amending its certificate of incorporation or through any reorganization, transfer of assets, consolidation, merger, dissolution, issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such actions as may be necessary or appropriate to protect the rights of Holder as set forth in this Warrant against impairment.  Without limiting the generality of the foregoing, the Company will (i) not increase the par value of any Warrant Shares above the amount payable therefor upon such exercise immediately prior to such increase in par value, (ii) take all such action as may be necessary or appropriate in order that the Company may validly and legally issue fully paid and nonassessable Warrant Shares upon the exercise of this Warrant, and (iii) use commercially reasonable efforts to obtain all such authorizations, exemptions or consents from any public regulatory body having jurisdiction thereof, as may be, necessary to enable the Company to perform its obligations under this Warrant.

Before taking any action which would result in an adjustment in the number of Warrant Shares for which this Warrant is exercisable or in the Exercise Price, the Company shall obtain all such authorizations or exemptions thereof, or consents thereto, as may be necessary from any public regulatory body or bodies having jurisdiction thereof.

f) Restrictions .  The Holder acknowledges that the Warrant Shares acquired upon the exercise of this Warrant, if not registered and the Holder does not utilize cashless exercise, will have restrictions upon resale imposed by state and federal securities laws.

g) Governing Law .  This Warrant and the rights and obligations of the parties hereunder shall be governed by, and construed in accordance with, the law of the State of New York, without regard to principles of conflicts of laws that would result in the application of the laws of any other jurisdiction.

h) Submission to Jurisdiction .  The Company agrees that any suit, action or proceeding with respect to this Warrant or any judgment entered by any court in respect thereof may be brought initially in the federal or state courts in New York, New York or

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in the courts of its own corporate domicile and irrevocably submits to t he exclusive jurisdiction of each such court for the purpose of any such suit, action, proceeding or judgment.  This Section 5(h) is for the benefit of the Holder only and, as a result, the Holder shall not be prevented from taking proceedings in any other courts with jurisdiction.  To the extent allowed by any Law, the Holder may take concurrent proceedings in any number of jurisdictions.

i) Waiver of Venue, Etc.   The Company irrevocably waives to the fullest extent permitted by law any objection that it may now or hereafter have to the laying of the venue of any suit, action or proceeding arising out of or relating to this Warrant and hereby further irrevocably waives to the fullest extent permitted by law any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum.  A final judgment (in respect of which time for all appeals has elapsed) in any such suit, action or proceeding shall be conclusive and may be enforced in any court to the jurisdiction of which the Company is or may be subject, by suit upon judgment.

j) Waiver of Jury Trial .  THE COMPANY AND THE HOLDER HEREBY IRREVOCABLY WAIVE, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY SUIT, ACTION OR PROCEEDING ARISING OUT OF OR RELATING TO THIS WARRANT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY.

k) No Waiver .  No failure on the part of the Holder to exercise and no delay in exercising, and no course of dealing with respect to, any right, power or privilege under this Warrant shall operate as a waiver thereof, nor shall any single or partial exercise of any right, power or privilege under this Warrant preclude any other or further exercise thereof or the exercise of any other right, power or privilege.  The remedies provided herein are cumulative and not exclusive of any remedies provided by law.

l) Expenses .  If the Company willfully and knowingly fails to comply with any provision of this Warrant, which results in any material damages to the Holder, the Company shall pay to the Holder such amounts as shall be sufficient to cover any actual, reasonable and documented attorneys’ fees, including those of appellate proceedings, incurred by the Holder in collecting any amounts due pursuant hereto or in otherwise enforcing any of its rights, powers or remedies hereunder.

m) Notices .  All notices, requests, instructions, directions and other communications provided for herein (including any modifications of, or waivers, requests or consents under, this Warrant) shall be given or made in writing (including by telecopy or email) delivered, if to the Company or the Holder, to its address specified on the signature pages hereto, or at such other address as shall be designated by such party in a written notice to the other party.  Except as otherwise provided in this Warrant, all such communications shall be deemed to have been duly given upon receipt of a legible copy thereof, in each case given or addressed as aforesaid.  All such communications provided for herein by telecopy shall be confirmed in writing promptly after the delivery of such

15


 

communication (it being understood that non-receipt of written confirmation of such communication shall not invalidate such communication) .

n) Limitation of Liability .  No provision hereof, in the absence of any affirmative action by the Holder to exercise this Warrant to purchase Warrant Shares, and no enumeration herein of the rights or privileges of the Holder, shall give rise to any liability of the Holder for the purchase price of any Common Stock or as a stockholder of the Company, whether such liability is asserted by the Company or by creditors of the Company.

o) Remedies .  The Holder, in addition to being entitled to exercise all rights granted by law, including recovery of damages, will be entitled to seek specific performance of its rights under this Warrant.  The Company agrees that monetary damages would not be adequate compensation for any loss incurred by reason of a breach by it of the provisions of this Warrant and hereby agrees to waive and not to assert the defense in any action for specific performance that a remedy at law would be adequate.

p) Successors and Assigns .  Subject to applicable securities laws, this Warrant and the rights and obligations evidenced hereby shall be binding upon and inure to the benefit of the successors and permitted assigns of the Company and the successors and permitted assigns of the Holder.  The provisions of this Warrant are intended to be for the benefit of any Holder from time to time of this Warrant and shall be enforceable by the Holder or any holder of Warrant Shares.

q) Amendments, Etc.   Except as otherwise expressly provided in this Warrant, any provision of this Warrant may be modified or supplemented only by an instrument in writing signed by the Company and the Holder.

r) Severability .  If any provision hereof is found by a court to be invalid or unenforceable, to the fullest extent permitted by any applicable Law the parties agree that such invalidity or unenforceability shall not impair the validity or enforceability of any other provision hereof.

s) Captions .  The captions and section headings appearing herein are included solely for convenience of reference and are not intended to affect the interpretation of any provision of this Warrant.

t) Counterparts .  This Warrant may be executed in any number of counterparts, all of which taken together shall constitute one and the same instrument and any of the parties hereto may execute this Warrant by signing any such counterpart.

(Signature Page Follows)

 

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IN WITNESS WHEREOF, the Company has caused this Warrant to be executed by its officer thereunto duly authorized as of the date first above indicated.

 

   

CAREDX, inc.

 

 

By: /s/ Michael Bell

     Name: Michael Bell

     Title:   Chief Financial Officer

 

Address for Notices:

 

3260 Bayshore Boulevard

Brisbane, CA 94005

Attn: Dr. Peter Maag

Email: pmaag@caredx.com

 

 

 

 

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Accepted and Agreed,

 

Perceptive Credit Holdings II, LP

 

By:

Perceptive Credit Opportunities GP, LLC, its general partner

By: /s/ Sandeep Dixit

Name: Sandeep Dixit

Title:   Chief Credit Officer

By: /s/ Sam Chawla

Name: Sam Chawla

Title:   Portfolio Manager

 

Address for Notices:

 

Perceptive Credit Holdings II, LP

c/o Perceptive Advisors LLC

51 Astor Place, 10th Floor

New York, NY  10003

Attn: Sandeep Dixit

Email: Sandeep@perceptivelife.com

 

 

[Signature Page to Warrant]


 

NOTICE OF EXERCISE

 

To: CAREDX, inc.

 

(1) The undersigned hereby elects to purchase ________ Warrant Shares of the Company pursuant to the terms of the attached Warrant (only if exercised in full), and tenders herewith payment of the exercise price in full, together with all applicable transfer taxes, if any.

(2) Payment shall take the form of (check applicable box):

[  ] in lawful money of the United States; or

[  ] if permitted, the cancellation of such number of Warrant Shares as is necessary, in accordance with the formula set forth in subsection 2(c) , to exercise this Warrant with respect to the maximum number of Warrant Shares purchasable pursuant to the cashless exercise procedure set forth in subsection 2(c) .

(3) Please issue said Warrant Shares in the name of the undersigned or in such other name as is specified below:

_______________________________

 

Check applicable box and fill in information:

[  ] The Warrant Shares shall be delivered to the following DWAC Account Number:

_______________________________

 

_______________________________

 

_______________________________

[  ] The Warrant Shares shall be delivered by physical delivery of a certificate to:

 

_______________________________

 

_______________________________

 

_______________________________

 

(4) Accredited Investor .  The undersigned is an “accredited investor” as defined in Regulation D promulgated under the Securities Act of 1933, as amended.

[SIGNATURE OF HOLDER]

 

Name of Investing Entity: ______________________________________________________________

Signature of Authorized Signatory of Investing Entity : ________________________________________

Name of Authorized Signatory: _________________________________________________________

Title of Authorized Signatory: __________________________________________________________

Date: _______________________________________________________________________________

 

 

 

 

[Signature Page to Warrant]


 

ASSIGNMENT FORM

 

(To assign the foregoing Warrant, execute this form and supply required information.  Do not use this form to purchase shares.)

FOR VALUE RECEIVED, the foregoing Warrant and all rights evidenced thereby are hereby assigned to

Name of Person to Whom Warrant is being Transferred::


 

 

 

Address of Person to Whom Warrant is being Transferred:


 

 


 

 

 

 

 

Number of Shares Subject to Warrant being Transferred:

 

 

Dated: _______________ __, ______

 

Holder’s Name:

 

Holder’s Signature:


 

 

 

Name of Authorized Signatory:

 

Title of Authorized Signatory:

 

Holder’s Address:

 

 

 

 

 

 

 

Exhibit 10.1
Execution Copy

 

 

March 1, 2018

 

Dr. Peter Maag

Chief Executive Officer

CareDx, Inc.

3260 Bayshore Blvd

Brisbane, CA 94005

 

Dear Dr. Maag:

CareDx, Inc. (the “ Borrower ”) has requested the commitment of Perceptive Credit Holdings II, LP (the “ Lender ” or “ Perceptive ”) to provide financing to the Borrower in the form of a Senior Term Loan Facility in an aggregate principal amount not to exceed $35,000,000 (the “ Facility ”).  Perceptive has agreed to provide such commitment on the terms set forth in this letter (the “ Commitment Letter ”).  The proceeds of the Facility will be used for general corporate purposes, including, without limitation, business development and licensing purposes, the refinancing of existing debt and the payment of fees and expenses associated with the negotiation, execution and implementation of the Facility.  The terms and provisions governing the Facility will be substantially as set forth in the draft of the documents set forth on Exhibit A hereto, with such changes which have been previously agreed to by the parties and further changes which are satisfactory to the Lender in its reasonable discretion, including the determination of financial covenants calculated in accordance with the draft Credit Agreement and Guaranty described on Exhibit A hereto.  Capitalized terms used herein and not otherwise defined shall have the meanings assigned to them in the Loan Documentation (as defined in Exhibit B hereto).

1. Commitments

Perceptive agrees to make a loan to you in an aggregate principal amount not to exceed $25,000,000 (the “ Tranche A Term Loan ”), subject only to the conditions set forth in Exhibit B to this Commitment Letter.  At the Borrower’s option, the Tranche A Term Loan shall be in a principal amount of either $15,000,000 or $25,000,000, it being understood that in the event that the Tranche A Term Loan is $15,000,000, the Lender’s commitment to provide any additional amount of the Tranche A Term Loan shall immediately expire without any further action. The Lender agrees upon the satisfaction (or waiver by the Lender) of all such conditions, the Lender shall disburse the Tranche A Term Loan to the Borrower (the “ Closing Date ”).

In addition, Perceptive also agrees to provide a Tranche B Term Loan to you in an aggregate principal amount of $10,000,000 (the “ Tranche B Term Loan ”), which may be borrowed on the Closing Date or within the one-year period following the Closing Date, subject only to the conditions set forth in Exhibit C to this Commitment Letter. The Lender agrees upon the satisfaction (or waiver by the Lender) of all such conditions, the Lender shall disburse the Tranche B Term Loan to the Borrower.

2. Fees and Expenses

As a condition to our commitment to provide the Facility, promptly upon the execution and delivery of this Commitment Letter by the Borrower, as consideration for the commitments and

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agreements of the Lender hereunder, you agree to pay a nonrefundable commitment fee to the Lender in the amount equal to $262,500 (the “ Commitment Fee ”).  The Commitment Fee shall be fully earned upon becoming due and payable in accordance with the terms hereof, and shall be in addition to any other fees, costs and expenses payable pursuant to the Loan Documentation.  

In addition, as a condition to our commitment to provide the Facility, promptly upon the execution and delivery of this Commitment Letter by the Borrower, you agree to pay Perceptive for all of its out-of-pocket fees, costs and expenses outstanding as of the date hereof (including, without limitation, the documented fees and expenses of legal counsel to Perceptive) less any deposits (the “ Expense Deposit ”) paid by the Borrower prior to the date hereof with respect to the Facility.  You also agree to reimburse us, regardless of whether or not the Closing Date occurs, for all of our reasonable out-of-pocket expenses (including, but not limited to, reasonably and documented attorneys’ fees) incurred from the date hereof through the earlier of the Closing Date or the termination of this Commitment Letter.

3. Indemnification

You agree to indemnify and hold harmless Perceptive and its officers, directors, employees, agents, advisors, controlling persons, members and other representatives and the successors and assigns of each of the foregoing (each, an " Indemnified Person ") from and against (and will reimburse each Indemnified Person as the same are incurred for) any and all losses, claims, damages, liabilities and expenses (including, without limitation, the reasonable fees, disbursements and other charges of counsel) that may be incurred by or asserted or awarded against any Indemnified Person, joint or several, to which any such Indemnified Person may become subject arising out of or in connection or by reason of (including, without limitation, in connection with any investigation, litigation or proceeding or preparation of a defense in connection therewith) with this Commitment Letter, the Facility or any related transaction or any claim, litigation, investigation or proceeding relating to any of the foregoing, regardless of whether any such Indemnified Person is a party thereto (and regardless of whether such matter is initiated by a third party or by the Borrower or any of their respective affiliates or equity holders); provided that the foregoing indemnity will not, as to any Indemnified Person, apply to losses, claims, damages, liabilities or related expenses to the extent that they are determined by a court of competent jurisdiction in a final and non-appealable decision to have resulted from (i) the willful misconduct or gross negligence of (A) such Indemnified Person, (B) any of such Indemnified Person's controlled affiliates, (C) any of its or their respective officers, directors, or employees or (D) to the extent acting on behalf of, or at the express instructions of, such Indemnified Person or controlled affiliate, any of its or their respective agents, in each case described in (B), (C) or (D) who are involved in the due diligence or negotiation of the Facility, (ii) a material breach of the obligations of such Indemnified Person or any such Indemnified Person's controlled affiliates under this Commitment Letter or the Loan Documentation or (iii) disputes between and among Indemnified Persons to the extent such disputes do not arise from any violation of this Commitment Letter by you.  You agree that, notwithstanding any other provision of this Commitment Letter, no Indemnified Person shall have any liability (whether direct or indirect, in contract or tort or otherwise) to you or your subsidiaries or affiliates or to your or their respective equity holders or creditors or any other person arising out of, related to or in connection with any aspect of the Facility, except to the extent of your direct, as opposed to special, indirect, consequential or punitive, damages.  We agree that, notwithstanding any other provision of this Commitment Letter, you shall have no liability (whether direct or indirect, in contract or tort or otherwise) to us or any Indemnified Person or any other person arising out of, related to or in connection with any aspect of the Facility, except to the extent of our or such person’s direct, as opposed to special, indirect, consequential or punitive, damages.

 

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4. Confidentiality

The Lender shall treat confidentially all information received by them from the Borrower or its affiliates and representatives in connection with the transactions and only use such information for the purposes of providing the Facility contemplated by this Commitment Letter; provided , however, nothing herein shall prevent the Lender from disclosing any such information (a)  to any participants or prospective lenders or participants and financing sources for Perceptive and its affiliates and related funds to obtain financing for its commitments hereunder, provided that such parties agree to be bound by this Section 4, (b) in any legal, judicial, or administrative proceeding or other compulsory process or otherwise as required by applicable law, rule or regulations or as requested by a governmental authority (in which case the Lender shall promptly notify you, in advance, to the extent permitted by law, rule or regulation), (c) upon the request or demand of any governmental or regulatory authority having jurisdiction over the Lender or any of its affiliates or upon the good faith determination by counsel that such information should be disclosed in light of ongoing oversight or review of the Lender by any governmental or regulatory authority having jurisdiction over the Lender or its affiliates (in which case the Lender shall promptly notify you, in advance, to the extent lawfully permitted to do so), (d) to the officers, directors, employees, legal counsel, independent auditors, professionals and other experts or agents of the Lender (collectively, “ Representatives ”) on a “need-to-know” basis and who are informed of the confidential nature of such information and have been advised of their obligation to keep information of this type confidential and the Lender shall be responsible for the compliance of its Representatives with this paragraph, (e) to any of its affiliates and Representatives of its affiliates on a “need-to-know” basis ( provided , that any such affiliate or Representative is advised of its obligation to retain such information as confidential, and the Lender shall be responsible for the compliance of its affiliates and Representatives of its affiliates with this paragraph) solely in connection with the Facilities and the related transactions, (f) to the extent any such information becomes publicly available other than by reason of disclosure by the Lender, its affiliates or Representatives in breach of this Commitment Letter or other obligation of confidentiality owed to the Borrower or their affiliates, (g) for purposes of establishing any defense, and (h) to the extent that such information is received by the Lender from a third party that is not known by the Lender to be subject to confidentiality obligations to the Borrower or its affiliates; provided , the disclosure of any such information to any prospective lenders or participants referred to above shall be made subject to the acknowledgment and acceptance by such prospective Lender or participant that such information is being disseminated on a confidential basis (on substantially the terms set forth in this paragraph or as is otherwise reasonably acceptable to you and the Lender, including, without limitation, as agreed in any confidential information memorandum or other marketing materials) in accordance with the customary market standards for dissemination of such type of information, in the event of any electronic access through an electronic system or platform, which shall in any event require “click through” or other affirmative action on the part of the recipient to access such information and acknowledge its confidentiality obligations in respect thereof, in each case on terms reasonably acceptable to you.  The Lender’s obligations under this paragraph shall automatically terminate and be superseded by the confidentiality provisions in the Loan Documentation upon the execution and delivery thereof; provided that if, and to the extent, the Loan Documentation is not executed and delivered by each of the Borrower and the Lender, Lender’s obligations under this paragraph shall automatically terminate two (2) years following the date of this Commitment Letter.

5. Exclusivity

 

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As consideration for the commitments and agreements of the Lender hereunder, the Borrower agrees to deal exclusively with Lender with respect to debt financings for the benefit of the Borrower or any of its subsidiaries during the period from and after the execution and delivery of the Commitment Letter and ending on the earlier to occur of (i) April 15, 2018, and (ii) the Closing Date of the Facility.

6. Assignments; Amendments; Governing Law, Etc .

This Commitment Letter and the commitments hereunder shall not be assignable by any party hereto without the prior written consent of each other party hereto (such consent not to be unreasonably withheld or delayed) (and any attempted assignment without such consent shall be null and void).  This Commitment Letter and the commitments hereunder are intended to be solely for the benefit of the parties hereto (and Indemnified Persons to the extent expressly set forth herein) and are not intended to confer any benefits upon, or create any rights in favor of, any person other than the parties hereto (and Indemnified Persons to the extent expressly set forth herein). This Commitment Letter may not be amended or any provision hereof waived or modified except by an instrument in writing signed by Perceptive and you.  This Commitment Letter may be executed in any number of counterparts, each of which shall be deemed an original and all of which, when taken together, shall constitute one agreement.  Delivery of an executed counterpart of a signature page of this Commitment Letter by facsimile transmission or other electronic transmission (i.e., a "pdf" or "tif") shall be effective as delivery of a manually executed counterpart hereof.  Section headings used herein are for convenience of reference only, are not part of this Commitment Letter and are not to affect the construction of, or to be taken into consideration in interpreting, this Commitment Letter. THIS COMMITMENT LETTER AND ANY CLAIM, CONTROVERSY OR DISPUTE ARISING UNDER OR RELATED TO THIS COMMITMENT LETTER (INCLUDING, WITHOUT LIMITATION, ANY CLAIMS SOUNDING IN CONTRACT LAW OR TORT LAW ARISING OUT OF THE SUBJECT MATTER HEREOF) SHALL BE GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF NEW YORK .

7. Jurisdiction .

Each of the parties hereto hereby irrevocably and unconditionally (a) submits, for itself and its property, to the exclusive jurisdiction of any New York State court or Federal court of the United States of America sitting in the Borough of Manhattan in New York City, and any appellate court from any thereof, in any suit, action or proceeding arising out of or relating to this Commitment Letter or the transactions contemplated hereby or thereby, and agrees that all claims in respect of any such suit, action or proceeding may be heard and determined only in such New York State court or, to the extent permitted by law, in such Federal court, (b) waives, to the fullest extent it may legally and effectively do so, any objection which it may now or hereafter have to the laying of venue of any suit, action or proceeding arising out of or relating to this Commitment Letter or the transactions contemplated hereby or thereby in any New York State court or in any such Federal court, (c) waives, to the fullest extent permitted by law, the defense of an inconvenient forum to the maintenance of such suit, action or proceeding in any such court and (d) agrees that a final judgment in any such suit, action or proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by law.  Service of any process, summons, notice or document by registered mail addressed to you at the address above shall be effective service of process against you for any suit, action or proceeding brought in any such court.

8. Waiver of Jury Trial .

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EACH OF THE PARTIES HERETO IRREVOCABLY WAIVES THE RIGHT TO TRIAL BY JURY IN ANY SUIT, ACTION, PROCE EDING, CLAIM OR COUNTERCLAIM BROUGHT BY OR ON BEHALF OF ANY PARTY RELATED TO OR ARISING OUT OF THIS COMMITMENT LETTER OR THE PERFORMANCE OF SERVICES HEREUNDER.

9. Surviving Provisions .

The Lender’s obligations under this paragraph shall automatically terminate and be superseded by the provisions in the Loan Documentation upon the execution and delivery thereof.

Upon the termination of this Commitment Letter prior to the closing of the Facility, the parties agree that the compensation, reimbursement, indemnification, confidentiality, jurisdiction, governing law and waiver of jury trial provisions contained herein shall remain in full force and effect.

10. Acceptance and Termination .

If the foregoing correctly sets forth our agreement with you, please indicate your acceptance of the terms of this Commitment Letter by returning to us executed counterparts hereof not later than 5:00 p.m., New York City time on March 1, 2018. Perceptive’s commitment hereunder, and our agreement to perform the services described herein, will expire automatically and without further action or notice and without further obligation to you at such time in the event that we have not received such executed counterparts in accordance with the immediately preceding sentence.  This Commitment Letter will become a binding commitment on us only after it has been duly executed and delivered by you in accordance with the first sentence of this Section 10.  In the event that the Closing Date does not occur on or before 5:00 p.m., New York City time, on April 15, 2018, then this Commitment Letter and Perceptive’s commitment hereunder, and our agreements to perform the services described herein, shall automatically terminate without further action or notice and without further obligation to you unless we shall, in our discretion, agree to an extension in writing.

 

 

 

[Remainder of Page Intentionally Blank]

 

 

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Very truly yours,

 

PERCEPTIVE CREDIT HOLDINGS II, LP

By: Perceptive Credit Opportunities GP, LLC
its general partner

 

 

By: /s/ Sandeep Dixit

Name: Sandeep Dixit

Title: Chief Credit Officer

 

By: /s/ Sam Chawla

Name: Sam Chawla

Title: Portfolio Manager

 

 

 

 

Agreed and Accepted this 1st day of March, 2018

 

CareDx, Inc .

 

 

By: /s/ Peter Maag

Name: Peter Maag

Title: Chief Executive Officer

 

 

Signature Page to Commitment Letter


 

EXHIBIT A

 

LOAN DOCUMENTATION

 

1. Credit Agreement and Guaranty (draft dated February 28, 2018)

2. Security Agreement (draft dated February 22, 2018)

3. Warrant ( draft dated February 27, 2018); provided that (i) the Tranche A Warrant shall provide for the purchase of either (x) 140,000 Common Shares (subject to adjustment for recapitalizations, stock dividends, stock splits and similar transactions) of the Borrower if the Tranche A Term Loan is $15,000,000, or (y) 233,333 Common Shares (subject to adjustment for recapitalizations, stock dividends, stock splits and similar transactions) if the Tranche A Term Loan is $25,000,000, (the “ Tranche A Warrant ”) and (ii) the Tranche B Warrant, if any, shall provide for the purchase an additional 93,333 Common Shares (subject to adjustment for recapitalizations, stock dividends, stock splits and similar transactions) (the “ Tranche B Warrant ”).

 

 

 

 

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EXHIBIT B

 

TRANCHE A CLOSING CONDITIONS

The obligation of the Lender to close and make available the Tranche A Term Loan under the Facility on the Closing Date is subject only to the execution and delivery of the definitive loan documents by the Borrower and the Lender, which shall be in form and substance satisfactory to the Lender in its reasonable discretion (provided that the Lender hereby agrees that the drafts of the documents set forth on Exhibit A hereto with such changes which have been previously agreed to by the parties and further changes which are reasonably satisfactory to the Lender, including the determination of financial covenants calculated in accordance with the draft Credit Agreement and Guaranty described on Exhibit A hereto) (the “ Loan Documentation ”), and the prior or concurrent satisfaction (or waiver thereof by the Lender) of each of the following conditions precedent:

(a) Secretary’s Certificate, Etc.   The Lender shall have received from each Obligor (i) a copy of a good standing certificate, dated a date reasonably close to the Closing Date, for each such Obligor and (ii) a certificate, substantially in the form delivered to the Lender on February 19, 2018, dated as of the Closing Date, duly executed and delivered by such Obligor’s Secretary or Assistant Secretary, managing member, general partner or equivalent, as to:

(i) resolutions of each such Obligor’s board of directors then in full force and effect authorizing the execution, delivery and performance of each loan document to be executed by such Obligor and the transactions contemplated thereunder;

(ii) the incumbency and signatures of those of its officers, managing member, general partner or equivalent authorized to act with respect to each loan document to be executed by such Obligor; and

(iii) copies of the certificate of incorporation, bylaws or similar governing document of such Obligor.

(b) Closing Date Certificate .  The Lender shall have received a certificate, dated as of the Closing Date and duly executed and delivered by a responsible officer of the Borrower, which certificate shall state that (i) both immediately before and after giving effect to the borrowing of the Tranche A Term Loan, (x) the representations and warranties set forth in the Loan Documentation shall, in each case, be true and correct in all material respects (or, in the case of any such representation or warranty already qualified by materiality, in all respects), (y) no default shall have then occurred and be continuing, or would result from the making of the loans being advanced on the Closing Date, and (ii) that all of the conditions set forth in the Loan Documentation have been satisfied or waived by the Lender.

(c) Solvency, Etc.   The Lender shall have received a solvency certificate, substantially in the form delivered by the Lender on February 22, 2018, duly executed and

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delivered by the chief financial or accounting officer of the Borrower, dated as of the Closing Date.

 

(d)

Financial Information, Etc.   The Lender shall have received:

(i) audited consolidated financial stat ements of the Borrower and its subsidiaries for the fiscal year ended December 31, 2016; provided that the Borrower’s filing of an Annual Report on Form 10-K with the SEC with respect thereto shall be deemed to satisfy the requirements of this Section; and

(ii) unaudited consolidated balance sheets of the Borrower and its subsidiaries for each fiscal quarter ended after December 31, 2016, other than fiscal quarter ended December 31, 2017, together with the related consolidated statement of operations for such fiscal quarter; provided that the Borrower’s filing of a Quarterly Report on Form 10-Q with the SEC with respect to each such quarter shall be deemed to satisfy the requirements of this Section.

(e) Compliance Certificate .  The Lender shall have received a compliance certificate, prepared on a pro forma basis as of the Closing Date demonstrating compliance with the financial covenants set forth in the Loan Documentation, duly executed (and with all schedules thereto duly completed) and delivered by a responsible officer of the Borrower.

(f) Opinions of Counsel . The Lender shall have an opinion, dated the Closing Date and addressed to the Lender, from Paul Hastings LLP, independent legal counsel to the Borrower and the other Obligors, substantially in the form delivered to the Lender on February 22, 2018.

(g) Material Adverse Change .  No material adverse change shall have occurred since December 31, 2017.

(h) Fees and Expenses, Etc.   The Lender shall have received, for its own account, the costs and expenses due and payable to it on the Closing Date in accordance with the Commitment Letter and a fee equal to 1.75% of the Tranche A Term Loan borrowed by the Borrower on the Closing Date, minus the Commitment Fee (the “ Tranche A Term Loan Closing Fee ”).

(i) Perfection Certificate . The Lender shall have received a fully completed perfection certificate, dated as of the Closing Date, substantially in the form delivered to the Lender on February 12, 2018, duly executed and delivered by a responsible officer of the Borrower.

 

(j) Delivery of Notes .  If the Lender has so requested, the Lender shall have received a note for its loan, substantially in the form delivered by the Lender on February 22, 2018, duly executed and delivered by a responsible officer of the Borrower.

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(k) Security Documents . The Lender shall have received executed counterparts of a security agreement (substantially in the form delivered by the Lender on February 22, 2018), a Swedish pledge agreement ( in a form to be agreed to by the parties and consistent with the security agreement) and short-form intellectual property security agreements (substantially in the form delivered to the Lender on February 22, 2018) , each dated as of the Closing Date , duly executed and delivered by each Obligor, together with:

(i) delivery of all certificates (in the case of equity interests that are securities (as defined in the NY UCC)) evidencing the issued and outstanding capital securities owned by each Obligor that are required to be pledged under such security agreement to the extent certificated, which certificates in each case shall be accompanied by undated instruments of transfer duly executed in blank or, in the case of equity interests that are uncertificated securities (as defined in the NY UCC), confirmation and evidence reasonably satisfactory to the Lender that such security interest required to be pledged therein under such security agreement has been transferred to and perfected by the Lender in accordance with Articles 8 and 9 of the NY UCC and all laws otherwise applicable to the perfection of the pledge of such equity interests.  For purposes hereof, “ NY UCC ” shall mean the Uniform Commercial Code as in effect in the state of New York;

(ii) financing statements naming each Obligor as a debtor and the Lender as the secured party (for the benefit of all other secured parties) or other similar instruments or documents, in each case suitable for filing, to be filed under the Uniform Commercial Code (or equivalent law) of all jurisdictions as may be necessary to perfect the liens of the Lender, pursuant to such security agreement;

(iii) UCC-1 (or equivalent) Lien searches reasonably satisfactory in scope and substance to the Administrative Agent covering each Obligor and its properties;

(iv) UCC‑3 termination statements, or equivalent, as may be necessary to release all liens and other rights of any person in any collateral of any Obligor described in such security agreement previously granted by any person;

(v) evidence that all deposit accounts, securities accounts and commodity accounts (other than accounts used for payroll, fiduciary and other trust accounts, government receivables accounts, and accounts to support letter of credit obligations of an Obligor) of each Obligor are subject to an account control agreement in favor of the Lender, in form and substance reasonably acceptable to the Lender.

(l) Warrant .  The Lender shall have received the executed Tranche A Warrant, dated as of the Closing Date, in form and substance reasonably acceptable to the Lender and substantially in the form of the draft delivered to the Borrower on February 27, 2018.

(m) Insurance .  The Lender shall have received certificates of insurance evidencing the existence of all insurance required to be maintained by the Obligors and their respective subsidiaries pursuant to the Loan Documentation and the designation of the Lender as

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the Borrower s loss payee or addi tional insured, as applicable, with any applicable endorsements therefor to be delivered upon receipt by the Borrower (which the Lender agrees may be after the Closing Date).

(n) Pay‑Off Letter .  The Lender shall have received an executed pay‑off letter terminating and cancelling the indebtedness to be repaid on the Closing Date in full, in form and substance reasonably acceptable to the Lender.

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EXHIBIT C

 

TRANCHE B CLOSING CONDITIONS

 

The obligation of the Lender to make available the Tranche B Term Loan under the Facility is subject only to each of the following conditions precedent:

 

(a) Tranche B Term Loan Borrowing Date Certificate .  The Lender shall have received a certificate, dated as of the proposed Tranche B Term Loan Borrowing Date and duly executed and delivered by a Responsible Officer of the Borrower stating that (i) both immediately before and after giving effect to the Borrowing, (x) the representations and warranties set forth in each Loan Document shall, in each case, be true and correct in all material respects (or, in the case of any such representation or warranty already qualified by materiality, in all respects) and (y) no Default shall have then occurred and be continuing, or would result from the making of the Loans being advanced on the proposed Tranche B Term Loan Borrowing Date and (ii) the condition set forth in clause (b) below has been satisfied or waived by the Lender.

(b) Minimum Product Revenue.   The consolidated Product Revenue of the Borrower and its Subsidiaries for the period of four (4) consecutive fiscal quarters ended on the last day of the fiscal quarter before the proposed Tranche B Term Loan Borrowing Date shall be not less than $47,000,000.

(c) Warrant .  The Lender shall have received the executed Tranche B Warrant, dated as of the Tranche B Term Loan Borrowing Date, in form and substance reasonably acceptable to the Lender and substantially in the form of the Tranche A Warrant (other than with respect to the amount of shares and exercise period thereof).

 

 

 

 

5

 

Exhibit 10.2

 

Execution Version

 



Credit Agreement and Guaranty


dated as of


April 17, 2018


among


CareDx, Inc .
as the Borrower,


Certain Subsidiaries of the Borrower from Time to Time Party hereto ,
as the Subsidiary Guarantors,


The Lenders from Time to Time Party hereto ,
as the Lenders,


and


Perceptive Credit Holdings II, LP
as the Administrative Agent


U.S. $35,000,000


 

 

 


Table of Contents

 

Section HeadingPage

SECTION 1.

Definitions. 1

 

 

Section 1.01.

Certain Defined Terms1

 

 

Section 1.02.

Accounting Terms and Principles26

 

 

Section 1.03.

Interpretation26

 

 

Section 1.04.

Changes to GAAP27

 

SECTION 2.

The Commitments and the Loans.28

 

 

Section 2.01.

Loans.28

 

 

Section 2.02.

Notes29

 

 

Section 2.03.

Use of Proceeds29

 

SECTION 3.

Payments of Principal and Interest.29

 

 

Section 3.01.

Repayments and Prepayments Generally; Application29

 

 

Section 3.02.

Interest.30

 

 

Section 3.03.

[Reserved].30

 

 

Section 3.04.

Prepayments; Prepayment Premium.30

 

 

Section 3.05.

Exit Fee32

 

 

Section 3.06.

Closing Fees32

 

SECTION 4.

Payments, Etc.32

 

 

Section 4.01.

Payments.32

 

 

Section 4.02.

Computations33

 

 

Section 4.03.

Set-Off.33

 

SECTION 5.

Yield Protection, Etc.33

 

 

Section 5.01.

Additional Costs.33

 

 

Section 5.02.

Illegality34

 

 

Section 5.03.

Taxes35

 

 

Section 5.04.

Delay in Requests39

 

SECTION 6.

Conditions Precedent.39

 

 

Section 6.01.

Conditions to the Closing Date39

 

 

Section 6.02.

Conditions to the Tranche B Term Loan; Tranche B Term Loan Borrowing Date42

 

SECTION 7.

Representations and Warranties.42

 

 

Section 7.01.

Power and Authority42

 

 

Section 7.02.

Authorization; Enforceability43

 

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Section 7.03.

Governmental and Other Approvals; No Conflicts 43

 

 

Section 7.04.

Financial Statements; Material Adverse Change.43

 

 

Section 7.05.

Properties.44

 

 

Section 7.06.

No Actions or Proceedings.46

 

 

Section 7.07.

Compliance with Laws and Agreements46

 

 

Section 7.08.

Taxes48

 

 

Section 7.09.

Full Disclosure48

 

 

Section 7.10.

Investment Company and Margin Stock Regulation.49

 

 

Section 7.11.

Solvency49

 

 

Section 7.12.

Equity Holders; Subsidiaries; Equity Investments49

 

 

Section 7.13.

Indebtedness and Liens49

 

 

Section 7.14.

Material Agreements49

 

 

Section 7.15.

Restrictive Agreements50

 

 

Section 7.16.

Real Property50

 

 

Section 7.17.

Pension Matters50

 

 

Section 7.18.

Collateral; Security Interest50

 

 

Section 7.19.

Regulatory Approvals50

 

 

Section 7.20.

[Reserved].52

 

 

Section 7.21.

OFAC52

 

 

Section 7.22.

Anti-Corruption52

 

 

Section 7.23.

Deposit and Disbursement Accounts53

 

 

Section 7.24.

Royalty and Other Payments53

 

SECTION 8.

Affirmative Covenants.53

 

 

Section 8.01.

Financial Statements and Other Information53

 

 

Section 8.02.

Notices of Material Events55

 

 

Section 8.03.

Existence; Conduct of Business57

 

 

Section 8.04.

Payment of Obligations57

 

 

Section 8.05.

Insurance58

 

 

Section 8.06.

Books and Records; Inspection Rights59

 

 

Section 8.07.

Compliance with Laws and Other Obligations59

 

 

Section 8.08.

Maintenance of Properties, Etc59

 

 

Section 8.09.

Maintenance of Regulatory Approvals and Material Intellectual Property59

 

 

Section 8.10.

Action Under Environmental Laws60

 

 

Section 8.11.

Use of Proceeds60

 

 

Section 8.12.

Certain Obligations Respecting Subsidiaries; Further Assurances.60

 

 

Section 8.13.

Termination of Non-Permitted Liens61

 

 

Section 8.14.

Intellectual Property62

 

 

Section 8.15.

ERISA Compliance62

 

 

Section 8.16.

Cash Management.62

 

 

Section 8.17.

Post-Closing Obligations63

 

SECTION 9.

Negative Covenants.63

 

 

Section 9.01.

Indebtedness63

 

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Section 9.02.

Liens 65

 

 

Section 9.03.

Fundamental Changes and Acquisitions67

 

 

Section 9.04.

Lines of Business68

 

 

Section 9.05.

Investments68

 

 

Section 9.06.

Restricted Payments69

 

 

Section 9.07.

Payments of Subordinated Indebtedness70

 

 

Sectio n 9.08.

Change in Fiscal Year70

 

 

Section 9.09.

Sales of Assets, Etc70

 

 

Section 9.10.

Transactions with Affiliates71

 

 

Section 9.11.

Restrictive Agreements71

 

 

Section 9.12.

Modifications and Terminations of Material Agreements and Organic Documents71

 

 

Section 9.13.

Inbound and Outbound Licenses.72

 

 

Section 9.14.

Sales and Leasebacks72

 

 

Section 9.15.

Hazardous Material73

 

 

Section 9.16.

Accounting Changes73

 

 

Section 9.17.

Compliance with ERISA73

 

SECTION 10.

Financial Covenants.73

 

 

Section 10.01.

Minimum Liquidity73

 

 

Section 10.02.

Minimum Product Revenue73

 

SECTION 11.

Events of Default.74

 

 

Section 11.01.

Events of Default74

 

 

Section 11.02.

Remedies76

 

 

Section 11.03.

Reserved.76

 

 

Section 11.04.

Exit Fee, Prepayment Premium and Redemption Price76

 

SECTION 12.

Guarantee.77

 

 

Section 12.01.

The Guarantee77

 

 

Section 12.02.

Obligations Unconditional77

 

 

Section 12.03.

Reinstatement78

 

 

Section 12.04.

Subrogation78

 

 

Section 12.05.

Remedies78

 

 

Section 12.06.

Reserved.79

 

 

Section 12.07.

Continuing Guarantee79

 

 

Section 12.08.

Rights of Contribution79

 

 

Section 12.09.

General Limitation on Guarantee Obligations79

 

SECTION 13.

Administrative Agent.80

 

 

Section 13.01.

Appointment80

 

 

Section 13.02.

Rights as a Lender80

 

 

Section 13.03.

Exculpatory Provisions80

 

 

Section 13.04.

Reliance by Administrative Agent81

 

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Section 13.05.

Delegation of Duties 81

 

 

Section 13.06.

Resignation of Agent82

 

 

Section 13.07.

Non-Reliance on Administrative Agent and Other Lenders83

 

 

Section 13.08.

Administrative Agent May File Proofs of Claim83

 

 

Section 13.09.

Collateral and Guaranty Matters; Appointment of Collateral Agent83

 

 

Section 13.10.

Swedish Pledge Agreement84

 

SECTION 14.

Miscellaneous.84

 

 

Section 14.01.

No Waiver84

 

 

Section 14.02.

Notices85

 

 

Section 14.03.

Expenses, Indemnification, Etc.85

 

 

Section 14.04.

Amendments, Etc86

 

 

Section 14.05.

Successors and Assigns.86

 

 

Section 14.06.

Survival88

 

 

Section 14.07.

Captions89

 

 

Section 14.08.

Counterparts89

 

 

Section 14.09.

Governing Law89

 

 

Section 14.10.

Jurisdiction, Service of Process and Venue.89

 

 

Section 14.11.

Waiver of Jury Trial 90

 

 

Section 14.12.

[Reserved].90

 

 

Section 14.13.

Entire Agreement90

 

 

Section 14.14.

Severability90

 

 

Section 14.15.

No Fiduciary Relationship90

 

 

Section 14.16.

Confidentiality90

 

 

Section 14.17.

Right of Setoff91

 

 

Section 14.18.

Judgment Currency91

 

 

Section 14.19.

USA PATRIOT Act92

 

 

Section 14.20.

Release of Collateral and Guarantees; Non-Disturbance Agreements92

 

 

Section 14.21.

Acknowledgement and Consent to Bail-In of EEA Financial Institutions92

 

 

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Schedules and Exhibits

Schedule  1 —Commitments and Warrant Shares

Schedule  2 —Products

Schedule  7.05(b) —Obligor Intellectual Property

Schedule  7.05(c) —Material Intellectual Property

Schedule  7.06(a) —Certain Litigation

Schedule  7.06(c) —Labor Matters

Schedule  7.12(b) —Information Regarding Subsidiaries

Schedule  7.12(c) —Equity Investments

Schedule  7.13(a) —Scheduled Indebtedness

Schedule  7.13(b) —Liens

Schedule  7.14 —Material Agreements of Obligors

Schedule  7.15 —Restrict ive Agreements

Schedule  7.16 —Real Property Owned or Leased by Obligors or any Subsidiary Schedule  7.17 —Pension Matters

Schedule  7.19(b) —Regulatory Approvals

Schedule  7.19(e) —Certain Regulatory Matters

Schedule  7.21 —OFAC Matters

Schedule  7.23 —De posit and Disbursement Accounts

Schedule  7.24 —Royalty and Payments

Schedule  8.16 —Cash Management

Schedule  8.17 —Post-Closing Obligations

Schedule  9.03 —Acquisitions

Schedule  9.05 —Existing Investments

Schedule  9.10 —Transactions with Affiliates

Schedule  9.13(a) —Existing Inbound Licenses

Schedule  9.13(b) —Existing Outbound Licenses

Schedule  9.14 —Permitted Sales and Leasebacks


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Exhibit  A Form of Note

Exhibit  B —Form of Borrowing Notice

Exhibit  C —Form of Guarantee Assumption Agreement

Exhibit  D-1 —Forms of U.S. Tax Compliance Certificate

Exhibit  D-2 —Forms of U.S. Tax Compliance Certificate

Exhibit  D-3 —Forms of U.S. Tax Compliance Certificate

Exhibit  D-4 —Forms of U.S. Tax Compliance Certificate

Exhibit  E —Form of Compliance Certificate

Exhibit  F —Form of Assignment and Assumption

Exhibit  G —Form of Landlord Consent

Exhibit  H —[Reserved]

Exhibit  I —Form of Perfection Certificate

Exhibit  J —Form of Patent Security Agreement

Exhibit  K —Form of Trademark Security Agreement

Exhibit  L —Form of Copyright Security Agreement

Exhibit  M —[Reserved]

Exhibit  N —Form of Closing Date Certificate

Exhibit  O —Tranche B Term Loan Borrowing Date Certificate

 

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Credit Agreement and Guaranty

Credit Agreement and Guaranty, dated as of April 17, 2018 (this “ Agreement ”), among CareDx, Inc., a Delaware corporation (the “ Borrower ”), certain of the Borrower’s Subsidiaries from time to time parties hereto, the lenders from time to time party hereto (each, a “ Lender ” and collectively, the “ Lenders ”), and Perceptive Credit Holdings II, LP, as administrative agent for the Lenders (in such capacity, the “ Administrative Agent ”).

Witnesseth:

Whereas , the Borrower has requested that the Lenders provide a senior secured term loan facility to the Borrower in an aggregate principal amount of $35,000,000; and

Whereas , the Lenders are willing, on the terms and subject to the conditions set forth herein, to provide such senior secured term loan facility.

Now, Therefore , the parties hereto agree as follows:

SECTION 1.

Definitions.

Section 1.01. Certain Defined Terms

.  As used herein, the following terms have the following respective meanings:

Accounting Change Notice ” has the meaning set forth in Section 1.04(a).

Acquisition ” means any transaction, or any series of related transactions, by which any Person directly or indirectly, by means of a take-over bid, tender offer, amalgamation, merger, purchase of assets, or similar transaction having the same effect as any of the foregoing, (i) acquires all or substantially all of the assets, business unit or division of any Person, (ii) acquires control of Equity Interests of a Person representing more than fifty percent (50%) of the ordinary voting power for the election of directors to the board of directors or other governing body of such Person, or (iii) acquires control of more than fifty percent (50%) of the Equity Interests in any Person.

Act ” has the meaning set forth in Section 14.19.

Administrative Agent ” has the meaning set forth in the preamble hereto.

Affiliate ” means, with respect to a specified Person, another Person that directly, or indirectly through one or more intermediaries, Controls or is Controlled by or is under common Control with the Person specified; provided that, with respect to any Lender, an Affiliate of such Lender shall include, without limitation, all of such Lender’s Related Funds, but shall exclude any portfolio companies or partners of such Lender or of such Related Funds.

Agreement ” has the meaning set forth in the introduction hereto.

Applicable Margin ” means nine percent (9.00%), as such percentage may be increased pursuant to Section 3.02(b).

 


 

Asset Sale ” has the meaning set forth in Section 9.09.

Assignment and Assumption ” means an assignment and assumption entered into by a Lender and an assignee of such Lender in substantially the form of Exhibit F.

Bail-In Action ” means the exercise of any Write-Down and Conversion Powers by the applicable EEA Resolution Authority in respect of any liability of an EEA Financial Institution.

Bail-In Legislation ” means, with respect to any EEA Member Country implementing Article 55 of Directive 2014/59/EU of the European Parliament and of the Council of the European Union, the implementing law for such EEA Member Country from time to time which is described in the EU Bail-In Legislation Schedule.

Bailee Letter ” means a bailee letter in form and substance reasonably satisfactory to the Administrative Agent.

Bankruptcy Code ” means Title 11 of the United States Code entitled “Bankruptcy.”

Board ” means, with respect to any Person, the board of directors (or equivalent management body) of such Person or any committee thereof duly authorized to act on behalf of such board or management body.

Borrower ” has the meaning set forth in the preamble hereto.

Borrower Parties ” has the meaning set forth in Section 14.03(c).

Borrowing ” means the borrowing of the Loans on a Borrowing Date.

Borrowing Date ” means the Tranche A Term Loan Borrowing Date or the Tranche B Term Loan Borrowing Date, as applicable.

Borrowing Notice ” means a written notice in substantially the form of Exhibit B.

Business Day ” means a day (other than a Saturday or Sunday) on which commercial banks are not authorized or required to close in New York City.

Calculation Date ” has the meaning set forth in Section 10.02.

Capital Lease Obligations ” means, as to any Person, the obligations of such Person to pay rent or other amounts under a lease of (or other agreement conveying the right to use) real and/or personal property which obligations are required to be classified and accounted for as a capital lease on a balance sheet of such Person under GAAP and, for purposes of this Agreement, the amount of such obligations shall be the capitalized amount thereof, determined in accordance with GAAP.

Casualty Event ” means the damage, destruction or condemnation, as the case may be, of property of any Person or any of its Subsidiaries excluding any such property with a fair market value as of the date thereof of less than $500,000 per occurrence.

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Casualty Event Reinvestment Notice ” has the meaning set forth in Section 3.04(b).

Change of Control ” means at any time of determination, either (i) the acquisition of ownership, directly or indirectly, beneficially or of record, by any Person (or group of Persons acting jointly or otherwise in concert) (other than the Management Investors) of Equity Interests of the Borrower having more than fifty percent (50%) of the aggregate ordinary voting power, determined on a fully diluted basis; (ii) the Borrower shall cease to own, directly or indirectly, beneficially and of record, (x) with respect to its Subsidiaries in existence on the Closing Date, at least that percentage of the issued and outstanding Equity Interests of such Subsidiaries owned on the Closing Date (except for any such securities in the nature of directors’ qualifying shares required pursuant to applicable Law) or (y) with respect to its Subsidiaries formed or acquired after the Closing Date, one hundred percent (100%) of the issued and outstanding Equity Interests of such Subsidiaries (except for any such securities in the nature of directors’ qualifying shares required pursuant to applicable Law), in each case free and clear of all Liens except Liens created by the Security Documents and other Permitted Liens, or (iii) the sale of all or substantially all of the property or business of the Borrower and its Subsidiaries, taken as a whole.

Claims ” includes litigations, demands, complaints, grievances, actions, suits, orders, charges, indictments, prosecutions, information (brought by a public prosecutor without grand jury indictment) or other similar processes, assessments or reassessments.

CLIA ” means the Clinical Laboratory Improvement Amendments of 1988 and the implementing federal regulatory standards and program of the Centers for Medicare & Medicaid Services of the U.S. Department of Health and Human Services.

Closing Date ” means April 17, 2018.

Code ” means the Internal Revenue Code of 1986, as amended.

Collateral ” means any asset or property of any Person in which a Lien is purported to be granted under any Loan Document (or all such property, as the context may require).

Commitment ” means, with respect to each Lender, such Lender’s Tranche A Term Loan Commitment and Tranche B Term Loan Commitment, and “ Commitments ” means all such commitments of all Lenders.  The aggregate Commitments of all Lenders as of the Closing Date is $35,000,000.

Commodity Account ” means a “Commodity Account” as defined in the NY UCC.

Compliance Certificate ” has the meaning set forth in Section 8.01(c).

Connection Income Taxes ” means Other Connection Taxes that are imposed on or measured by net income (however denominated) or that are franchise Taxes or branch profits Taxes.

Contracts ” means any written contract, license, lease, agreement, obligation, promise, undertaking, understanding, arrangement, document, commitment, entitlement or engagement

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under which a Person has, or will have, any liability or contingent liability (in each case, whether in respect of monetary or payment obligations, performance obligations or otherwise).

Control ” means, in respect of a particular Person, the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of such Person, whether through the ability to exercise voting power, by contract or otherwise.  “Controlling” and “Controlled” have meanings correlative thereto.

Controlled Account ” has the meaning set forth in Section 8.16(a).

Copyright ” means all copyrights, copyright registrations and applications for copyright registrations, including all renewals and extensions thereof.

Default ” means any event that has occurred which, upon the giving of notice thereof, or the lapse of time, or both, would constitute an Event of Default.

Default Rate ” has the meaning set forth in Section 3.02(b).

Deposit Account ” is defined in the Security Agreement.

Designated Jurisdiction ” means any country or territory to the extent that such country or territory is the subject of any Sanction.

Device ” means any test, medical instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related item, including any component, part or accessory, that (i) is intended for use in the diagnosis of disease, malady or other conditions or in the cure, mitigation, treatment or prevention of disease or malady, in humans or animals, or is intended to affect the structure or any function of the body of humans or animals, (ii) does not achieve its primary intended purpose or purposes through chemical action within or on the body of humans or animals and (iii) is not dependent upon being metabolized for the achievement of its primary intended purpose or purposes.

Device Clearance Application ” means (i) any premarket approval application submitted under Section 515 of the FD&C Act (21 U.S.C. § 360e) (a “ PMA ”), (ii) any de novo request submitted under Section 513(f) of the FD&C Act (21 U.S.C. § 360c(f)), (iii) any 510(k) submitted under Section 510(k) of the FD&C Act (21 U.S.C. § 360(k)) seeking clearance from the FDA for a Device that is substantially equivalent to a legally marketed predicate Device, as defined in the FD&C Act (a “ 510(k) ”), (iv) any corresponding or substantially equivalent notification, application or clearance of a non-U.S. Regulatory Authority, including, with respect to the European Union, any equivalent submission to EMA or a Standard Body pursuant to an applicable directive of the European Council with respect to CE marking (or, if applicable, a self-certification of conformity with respect to any such directive through a “declaration of conformity”) and (v) all amendments, variations, extension and renewals of any of the foregoing.

Disqualified Equity Interests ” means, with respect to any Person, any Equity Interest of such Person that, by its terms (or by the terms of any security or other Equity Interest into which it is convertible or for which it is exchangeable), or upon the happening of any event or condition (i) matures or is mandatorily redeemable (other than solely for Qualified Equity Interests),

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including pursuant to a sinking fund obligation or otherwise, (ii) is redeemable at the option of the holder thereof (other than solely for Qualified Equity Interests), in whole or in p art, (iii) provides for the scheduled payments of dividends in cash, or (iv) is or becomes convertible into or exchangeable for Indebtedness or any other Equity Interests that would constitute Disqualified Equity Interests, in each case, prior to the date that is ninety (90) days after the Maturity Date; provided that, if such Equity Interests are issued pursuant to any plan for the benefit of directors, officers, employees or consultants of such Person or by any such plan to such directors, officers, emplo yees or consultants, such Equity Interests shall not constitute Disqualified Equity Interests solely because they may be required to be repurchased by such Person upon the death, disability, retirement or termination of employment or service of such direct or, officer, employee or consultant.

Dollars ” and “ $ ” means lawful money of the United States of America.

Domestic Foreign Holding Company ” shall mean any Subsidiary that is organized or incorporated in the United States, any state or territory thereof or the District of Columbia and substantially all the assets of which are Equity Interests and/or Indebtedness of one or more Foreign Subsidiaries.

Domestic Subsidiary ” means any Subsidiary that is a corporation, limited liability company, partnership or similar business entity incorporated, formed or organized under the laws of the United States, any State of the United States or the District of Columbia, excluding in all cases (i) any Domestic Foreign Holding Company and (ii) any Subsidiary of a Foreign Subsidiary or a Domestic Foreign Holding Company.

EEA Financial Institution ” means (a) any credit institution or investment firm established in any EEA Member Country which is subject to the supervision of an EEA Resolution Authority, (b) any entity established in an EEA Member Country which is a parent of an institution described in clause (a) of this definition, or (c) any financial institution established in an EEA Member Country which is a subsidiary of an institution described in clauses (a) or (b) of this definition and is subject to consolidated supervision with its parent.

EEA Member Country ” means any of the member states of the European Union, Iceland, Liechtenstein, and Norway.

EEA Resolution Authority ” means any public administrative authority or any person entrusted with public administrative authority of any EEA Member Country (including any delegee) having responsibility for the resolution of any EEA Financial Institution.

Eligible Transferee ” means and includes (i) any commercial bank, (ii) any insurance company, finance company, financial institution, investment fund and any other “accredited investor” (as defined in Regulation D of the Securities Act), in each case, that is principally in the business of managing debt investments or holding credit assets for investment purposes and (iii) any Affiliate of a Lender; provided that so long as no Event of Default has occurred and is continuing, an Eligible Transferee shall not include any competitor of the Borrower or any of its Subsidiaries.

EMA ” means the European Medicines Agency or any successor entity.

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Environmental Law ” means any federal, state, provincial or local governmental law, rule, regulation, order, writ, judgment, injunction or decree, whether U.S. or non-U.S., relating to pollution or protection of the environment or the treatment, storage, disposal, release, threatened release or handling of hazardous materials, and all local laws and regulations, whether U.S. or non-U.S., related to environmental matters and any specific agreements entered into with any Governmental Authorities which include commitments related to environmental matters.

Equity Interests ” means, with respect to any Person (for purposes of this defined term, an “issuer”), all shares of, interests or participations in, or other equivalents in respect of such issuer’s capital stock, including all membership interests, partnership interests or equivalent, and all debt or other securities directly or indirectly exchangeable, exercisable or otherwise convertible into such issuer’s capital stock, whether outstanding as of the Closing Date or issued after the Closing Date, and in each case however designated and whether voting or non-voting.

Equivalent Amount ” means, with respect to an amount denominated in one (1) currency, the amount in another currency that could be purchased by the amount in the first currency determined by reference to the Exchange Rate at the time of determination.

ERISA ” means the United States Employee Retirement Income Security Act of 1974, as amended.

ERISA Affiliate ” means, collectively, any Obligor, Subsidiary thereof, and any Person under common control, or treated as a single employer, with any Obligor or Subsidiary thereof, within the meaning of Section 414(b), (c) or, solely with respect to Code Section 412 or ERISA Section 302, (m) or (o) of the Code.

ERISA Event ” means (i) a reportable event as defined in Section 4043 of ERISA with respect to a Title IV Plan, excluding, however, such events as to which the PBGC by regulation has waived the requirement of Section 4043(a) of ERISA that it be notified within thirty (30) days of the occurrence of such event; (ii) a withdrawal by any Obligor or any ERISA Affiliate thereof from a Title IV Plan or the termination of any Title IV Plan resulting in liability under Sections 4063 or 4064 of ERISA; (iii) the withdrawal of any Obligor or any ERISA Affiliate thereof in a complete or partial withdrawal (within the meaning of Section 4203 and 4205 of ERISA) from any Multiemployer Plan if there is any liability therefore, or the receipt by any Obligor or any ERISA Affiliate thereof of notice from any Multiemployer Plan that it is in insolvency pursuant to 4245 of ERISA; (iv) the filing of a notice of intent to terminate, the treatment of a plan amendment as a termination under Section 4041 or 4041A of ERISA, or the commencement of proceedings by the PBGC to terminate a Title IV Plan or Multiemployer Plan; (v) the imposition of liability on any Obligor or any ERISA Affiliate thereof pursuant to Sections 4062(e) or 4069 of ERISA or by reason of the application of Section 4212(c) of ERISA; (vi) the failure by any Obligor or any ERISA Affiliate thereof to make any required contribution to a Plan, or the failure to meet the minimum funding standard of Section 412 of the Code with respect to any Title IV Plan (whether or not waived in accordance with Section 412(c) of the Code) or the failure to make by its due date a required installment under Section 430 of the Code with respect to any Title IV Plan or the failure to make any required contribution to a Multiemployer Plan; (vii) the determination that any Title IV Plan is considered an at-risk plan or a plan in endangered to critical status within the meaning of Sections 430, 431 and 432 of the

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Code or Sect ions 303, 304 and 305 of ERISA; (viii) an event or condition which would reasonably be expected to constitute grounds under Section 4042 of ERISA for the termination of, or the appointment of a trustee to administer, any Title IV Plan or Multiemployer Plan ; (ix) the imposition of any liability under Title I or Title IV of ERISA, other than PBGC premiums due but not delinquent under Section 4007 of ERISA, upon any Obligor or any ERISA Affiliate thereof; (x) an application for a funding waiver under Section 4 12 of the Code or an extension of any amortization period pursuant to Section 433 of the Code with respect to any Title IV Plan; or (xi) the imposition of any lien (or the fulfillment of the conditions for the imposition of any lien) on any of the rights, properties or assets of any Obligor or any ERISA Affiliate thereof, pursuant to Title IV of ERISA, 303(k) of ERISA or Section 430(k) of the Code.

EU Bail-In Legislation Schedule ” means the EU Bail-In Legislation Schedule published by the Loan Market Association (or any successor Person), as in effect from time to time.

Event of Default ” has the meaning set forth in Section 11.01.

Excess Funding Guarantor ” has the meaning set forth in Section 12.08.

Excess Payment ” has the meaning set forth in Section 12.08.

Exchange Act ” means the Securities Exchange Act of 1934, as amended.

Exchange Rate ” means, as of any date, the rate at which any currency may be exchanged into another currency, as set forth on the relevant Reuters screen at or about 11:00 a.m. (Eastern time) on such date.  In the event that such rate does not appear on the Reuters screen, the “Exchange Rate” shall be determined by reference to such other publicly available service for displaying exchange rates as may be reasonably determined by the Administrative Agent.

Excluded Account ” means, collectively, (i) accounts used exclusively for payroll, the withheld employee portion of payroll taxes and other employee wage and benefit payments, (ii) fiduciary and other trust accounts, (iii) Government Receivables Accounts and (iv) accounts to support Indebtedness permitted by Section 9.01(o); provided that the balance in such accounts is no more than 105% of such Indebtedness.

Excluded Taxes ” means any of the following Taxes imposed on or with respect to a Recipient or required to be withheld or deducted from a payment to a Recipient:  (i) Taxes imposed on or measured by net income (however denominated), franchise Taxes and branch profits Taxes, in each case, (x) imposed as a result of such Recipient being organized under the laws of, or having its principal office or, in the case of any Lender, its applicable lending office located in, the jurisdiction imposing such Tax (or any political subdivisions thereof) or (y) that are Other Connection Taxes, (ii) in the case of a Lender, U.S. federal withholding Taxes imposed on amounts payable to or for the account of such Lender with respect to an applicable interest in a Loan or Commitment pursuant to a law in effect on the date on which (1) such Lender acquires such interest in the Loan or Commitment (other than pursuant to an assignment request by the Borrower pursuant to Section 5.03(h)) or (2) such Lender changes its lending office, except in each case to the extent that, pursuant to Section 5.03, amounts with respect to such Taxes were payable either to such Lender’s assignor immediately before such Lender became a party hereto

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or to such Lender immediately before it changed its lending office, (iii) Taxes attributable to such Recipient’s failure to comply w ith Section 5.03(f), and (iv) any withholding Taxes imposed under FATCA.

Exit Fee ” has the meaning set forth in Section 3.05.

Fair Share ” has the meaning set forth in Section 12.08.

FATCA ” means Sections 1471 through 1474 of the Code, as of the date of this Agreement (or any amended or successor version that is substantively comparable and not materially more onerous to comply with), any current or future regulations or official interpretations thereof, any agreements entered into pursuant to Section 1471(b)(1) of the Code, and any fiscal or regulatory legislation, rules or practices adopted pursuant to any intergovernmental agreement, treaty or convention among Governmental Authorities and implementing such Sections of the Code.

FD&C Act ” means the U.S. Food, Drug and Cosmetic Act of 1938 (or any successor thereto), as amended from time to time, and the rules and, regulations promulgated thereunder.

FDA ” means the U.S. Food and Drug Administration and any successor entity.

FDA Laws ” means all applicable statutes, rules, regulations, standards, and orders administered or issued by the FDA, including without limitation, the FD&C Act and its implementing regulations.

Federal Health Care Program ” has the meaning specified in Section 1128B(f) of the Social Security Act and includes the programs commonly known as Medicare, Medicaid, TRICARE and CHAMPVA.

Foreign Lender ” means a Lender (or, if the Lender is a disregarded entity for U.S. federal income tax purposes, the Person treated as the owner of the assets of such Lender for U.S. federal income tax purposes) that is not a U.S. Person.

Foreign Subsidiary ” means a Subsidiary of the Borrower that is not incorporated, formed or organized under the laws of the United States, any State of the United States or the District of Columbia.

GAAP ” means generally accepted accounting principles in the United States of America, as in effect from time to time, set forth in the opinions and pronouncements of the Accounting Principles Board and the American Institute of Certified Public Accountants, in the statements and pronouncements of the Financial Accounting Standards Board and in such other statements by such other entity as may be in general use by significant segments of the accounting profession that are applicable to the circumstances as of the date of determination.  The definition of GAAP shall be subject to Sections 1.02 and 1.04.

Government Healthcare Receivable ” means any account receivable or other right to payment of a monetary obligation from a Governmental Authority in respect of the sale or

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provision of health care services, including Federal Health Care Program receivables and “health-care-insurance receivables” (as defined in the NY UCC).

Government Receivables Account ” means a deposit account of an Obligor with a financial institution which deposit account holds proceeds of payments received in respect of Government Healthcare Receivables.

Governmental Approval ” means any required consent, authorization, approval, order, license, franchise, permit, certification, accreditation, registration, clearance, exemption, filing or notice that is issued or granted by or from (or pursuant to any act of) any applicable Governmental Authority, including any application or submission related to any of the foregoing.

Governmental Authority ” means any nation, government, branch of power (whether executive, legislative or judicial), state, province or municipality or other political subdivision thereof and any entity exercising executive, legislative, judicial, monetary, regulatory or administrative functions of or pertaining to government, including without limitation regulatory authorities, governmental departments, agencies, commissions, bureaus, officials, ministers, courts, bodies, boards, tribunals and dispute settlement panels, and other law-, rule- or regulation-making organizations or entities of any state, territory, county, city or other political subdivision of any country, in each case whether U.S. or non-U.S.

Guarantee ” of or by any Person (the “ guarantor ”) means any obligation, contingent or otherwise, of the guarantor guaranteeing or having the economic effect of guaranteeing any Indebtedness or other monetary obligation of any other Person (the “ primary obligor ”) in any manner, whether directly or indirectly, and including any obligation of the guarantor, direct or indirect, (i) to purchase or pay (or advance or supply funds for the purchase or payment of) such Indebtedness or other monetary obligation or to purchase (or to advance or supply funds for the purchase of) any security for the payment thereof, (ii) to purchase or lease property, securities or services for the purpose of assuring the owner of such Indebtedness or other monetary obligation of the payment thereof, (iii) to maintain working capital, equity capital or any other financial statement condition or liquidity of the primary obligor so as to enable the primary obligor to pay such Indebtedness or other monetary obligation, or (iv) as an account party in respect of any letter of credit or letter of guaranty issued to support such Indebtedness or monetary obligation; provided that the term Guarantee shall not include endorsements for collection or deposit in the ordinary course of business.  The amount of any Guarantee shall be deemed to be an amount equal to the stated or determinable amount of the related primary obligation, or portion thereof, in respect of which such Guarantee is made or, if not stated or determinable, the maximum reasonably anticipated liability in respect thereof as determined by the guaranteeing Person in good faith.

Guarantee Assumption Agreement ” means a Guarantee Assumption Agreement substantially in the form of Exhibit C by an entity that, pursuant to Section 8.12(a), is required to become a “Subsidiary Guarantor.”

Guaranteed Obligations ” has the meaning set forth in Section 12.01.

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Hazardous Material ” means any substance, element, chemical, compound, product, solid, gas, liquid, waste, by-product, pollutant, contaminant or material which is hazardous or toxi c, and includes, without limitation, (i) asbestos, polychlorinated biphenyls and petroleum (including crude oil or any fraction thereof) and (ii) any material classified or regulated as “hazardous” or “toxic” or words of like import pursuant to an Environm ental Law.

Health Care Compliance Program ” has the meaning set forth in Section 7.07(b)(ix).

Healthcare Laws ” means, collectively, all Laws applicable to the business of the Borrower or any other Obligor whether U.S. or non-U.S., regulating the manufacturing, labeling, promotion, distribution or sale, or the provision of and payment for, health care products, items and services, including but not limited to:  (i) Laws relating to the privacy or security of patient information, including but not limited to the HIPAA and any similar state laws, (ii) federal and state fraud and abuse Laws, including but not limited to the federal Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)) and any similar state laws, the federal Physician Self-Referral Prohibition (commonly referred to as the “Stark Law”) (42 U.S.C. § 1395nn) and any similar state Laws, the Civil Monetary Penalties Act (42 U.S.C. §1320a-7a), and the federal False Claims Act (31 U.S.C. §3729 et seq.) and any similar state laws, (iii) FDA Laws, including but not limited to the FDA’s “Good Manufacturing Practice” requirements (21 C.F.R. Part 820), “Medical Devices Regulations” (21 C.F.R. Part 812, and Parts 50, 54, and 56), and “Labeling Regulations” (21 C.F.R. Part 801), (iv) Laws regarding the provision of health care supplies, items or services to Federal Health Care Program beneficiaries or the billing of the Federal Health Care Programs, (v) CLIA and state clinical laboratory laws, (vi) state Laws regarding prohibitions on fee-splitting, (vii) Law relating to health care facility or health care professional licensure, and (viii) all rules and regulations promulgated under to pursuant to any of the foregoing.

Hedging Agreement ” means any interest rate exchange agreement, foreign currency exchange agreement, commodity price protection agreement or other interest or currency exchange rate or commodity price hedging arrangement.

HIPAA ” means the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of the American Recovery and Reinvestment Act of 2009.

IDE ” means an application, including an application filed with any Regulatory Authority, for authorization to commence human clinical studies with respect to any Device, including (i) an Investigational Device Exemption as defined in the FD&C Act or any successor application or procedure filed with the FDA, (ii) an abbreviated Investigational Device Exemption as specified in FDA regulations in 21 C.F.R. § 812.2(b), (iii) any equivalent of any of the foregoing pursuant to or under any non-U.S. country or regulatory jurisdiction, and (iv) all amendments, variations, extensions and renewals of any of the foregoing that may be filed with respect thereto.

Impermissible Qualification ” means any qualification or exception to the opinion or certification of any independent public accountant as to any financial statement of the Borrower or any of its Subsidiaries which is of a “going concern” or similar nature.

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Indebtedness ” of any Person means, without duplication, (i) all obligations of such Person for borrowed money, (ii) all obligations of such Person evidenced by bonds, debentures, notes or similar instruments, (iii) all obligations of such Person upon which interest ch arges (but only to the extent required by GAAP to be included as such on the balance sheet of the Borrower or any of its Subsidiaries) are customarily paid, (iv) [reserved], (v) all obligations of such Person in respect of the deferred purchase price of pr operty or services or under conditional sale or other title retention agreements relating to property acquired by such Person, and including any purchase price adjustments or indemnity requirements incurred in connection with any Permitted Acquisition (exc luding current trade accounts payable incurred in the ordinary course of business and including the foregoing only to the extent required by GAAP to be included on the balance sheet of the Borrower), (vi) all Indebtedness of others secured by (or for which the holder of such Indebtedness has an existing right, contingent or otherwise, to be secured by) any Lien on property owned or acquired by such Person, whether or not the Indebtedness secured thereby has been assumed, (vii) all Guarantees by such Person of Indebtedness of others, (viii) all Capital Lease Obligations of such Person, (ix) all obligations, contingent or otherwise, of such Person as an account party in respect of letters of credit and letters of guaranty, (x) obligations under any Hedging Agr eement, currency swaps, forwards, futures or derivatives transactions, (xi) all obligations, contingent or otherwise, of such Person in respect of bankers’ acceptances, (xii) all obligations of such Person under license or other agreements containing a gua ranteed minimum payment or purchase by such Person, other than operating leases entered into in the ordinary course of business and any such license or other agreement for the purchase or use of goods, software and other intangibles, services or supplies i n the ordinary course of business (but only to the extent required by GAAP to be included as such on the balance sheet of the Borrower or any of its Subsidiaries) and (xiii) any Disqualified Equity Interests of such Person.  The Indebtedness of any Person shall include the Indebtedness of any other entity (including any partnership in which such Person is a general partner) to the extent such Person is liable therefor as a result of such Person’s ownership interest in or other relationship with such entity, except to the extent the terms of such Indebtedness provide that such Person is not liable therefor.

Indemnified Party ” has the meaning set forth in Section 14.03(c).

Indemnified Taxes ” means (i) Taxes, other than Excluded Taxes, imposed on or with respect to any payment made by or on account of any Obligation and (ii) to the extent not otherwise described in clause (i), Other Taxes.

Insolvency Proceeding ” means (i) any case, action or proceeding before any court or other Governmental Authority relating to bankruptcy, reorganization, insolvency, liquidation, receivership, dissolution, winding-up or relief of debtors, or (ii) any general assignment for the benefit of creditors, composition, marshaling of assets for creditors, or other, similar arrangement in respect of any Person’s creditors generally or any substantial portion of such Person’s creditors, in each case undertaken under U.S. Federal, state or foreign Law, including the Bankruptcy Code.

Intellectual Property ” means all Patents, Trademarks, Copyright, and Technical Information, whether registered or not and whether existing under, U.S. or non-U.S. Law or jurisdiction, including (without limitation) all of the following:  (i) all applications or registrations relating to the foregoing; (ii) all rights and privileges arising under any applicable

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Law with respect to the foregoing; (iii) rights to sue for past, present or future infringements of such Patents, Trademarks, Copyrights and Technical Information, as applicable; and (iv) all rights of t he same or similar effect or nature in any jurisdiction corresponding to such Patents, Trademarks, Copyrights and Technical Information, as applicable, anywhere in the world.

Interest Period ” means, (i) with respect to the Tranche A Term Loan, (a) the period commencing on (and including) the Tranche A Term Loan Borrowing Date and ending on (and including) the last day of the calendar month in which such Tranche A Term Loan Borrowing Date occurs, and (b) thereafter, the period beginning on (and including) the first day of each succeeding calendar month and ending on the earlier of (and including) (x) the last day of such calendar month and (y) the Maturity Date, and (ii) with respect to the Tranche B Term Loan, (a) the period commencing on (and including) the Tranche B Term Loan Borrowing Date and ending on (and including) the last day of the calendar month in which such Tranche B Term Loan Borrowing Date occurs, and (b) thereafter, the period beginning on (and including) the first day of each succeeding calendar month and ending on the earlier of (and including) (x) the last day of such calendar month and (y) the Maturity Date.

Interest Rate ” means the sum of (i) the Applicable Margin plus (ii) the greater of (x) the Reference Rate and (y) one and one-half percent (1.50%).

Invention ” means any novel, inventive or useful art, apparatus, method, process, machine, manufacture or composition of matter, or any novel, inventive and useful improvement in any art, method, process, machine, manufacture or composition of matter.

Investment ” means, for any Person:  (i) any direct or indirect acquisition or investment by such Person, whether by means of (a) the purchase or other acquisition of Equity Interests or debt or other securities of another Person, (ii) a loan, advance or capital contribution to, guarantee or assumption of debt of, or purchase or other acquisition of any other debt or equity participation or interest in, another Person, including any partnership or joint venture interest in such other Person, or (iii) the purchase or other acquisition (in one transaction or a series of transactions) of all or substantially all of the property and assets or business of another Person or assets constituting a business unit, line of business or division of such Person.  The amount of an Investment will be determined at the time the Investment is made without giving effect to any subsequent changes in value.

IRS ” means the U.S. Internal Revenue Service or any successor agency.

knowledge ” or words of similar import shall mean the actual knowledge, after reasonable inquiry, of a Responsible Officer of the Borrower.

Landlord Consent ” means a Landlord Consent substantially in the form of Exhibit G or in a form otherwise reasonably satisfactory to the Administrative Agent.

Law ” means, with respect to any Person, any U.S. or non-U.S. federal, state, provincial, territorial, municipal or local statute, treaty, rule, guideline, regulation, ordinance, code or administrative or judicial precedent or authority, including any interpretation or administration thereof by any Governmental Authority charged with the enforcement, interpretation or administration thereof, and all applicable administrative orders, directed duties, requests,

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licenses, authorizations and permits of, and a greements with, any Governmental Authority, in each case that are applicable to or binding upon such Person or any of its property or to which such Person or any of its property is subject.

Lenders ” has the meaning set forth in the preamble hereto.

Lien ” means any mortgage, lien, pledge, charge or other security interest, or any lease, title retention agreement, easement, right-of-way or other encumbrance of any kind or character whatsoever or any preferential arrangement that has the practical effect of creating a security interest.

Loan ” means each loan advanced by a Lender pursuant to Section 2.01.

Loan Documents ” means, collectively, this Agreement, the Notes, the Warrants, the Security Documents, the Guarantee Assumption Agreements and any subordination agreement, intercreditor agreement or other present or future document, instrument, agreement or certificate delivered to any Lender in connection with this Agreement or any of the other Loan Documents, in each case, as amended, restated, supplemented or otherwise modified.

Loss ” means any judgment, debt, liability, expense, cost, damage or loss, contingent or otherwise, whether liquidated or unliquidated, matured or unmatured, disputed or undisputed, contractual, legal or equitable, including loss of value, professional fees, including reasonable and documented fees and disbursements of legal counsel, and all costs incurred in investigating or pursuing any Claim or any proceeding relating to any Claim.

Majority Lenders ” means, at any time, Lenders having at such time in excess of fifty percent (50%) of the aggregate Commitments (or, if such Commitments are terminated, the outstanding principal amount of the Loans) then in effect.

Management Investors ” means any current directors, officers, management and/or employees of the Borrower or any of its Subsidiaries and any of their respective family members, trusts or other estate planning vehicles and any Person owned or controlled by any of the foregoing, in each case, holding, beneficially or of record, Equity Interests in the Borrower.

Margin Stock ” means “margin stock” within the meaning of Regulations T, U and X.

Material Adverse Change ” and “ Material Adverse Effect ” mean a material adverse change in or effect on (i) the business, financial condition of the assets, operations or financial performance of the Borrower and its Subsidiaries, taken as a whole, (ii) the ability of either (x) the Borrower or (y) the Obligors, taken as a whole, to perform its or their, as the case may be, obligations under the Loan Documents, as and when due or (iii) the legality, validity, binding effect or enforceability of any Loan Document or the rights and remedies of any Secured Party under any of the Loan Documents.

Material Agreement ” means (i) any Contract to which any Obligor is a party that (x) relates to any Product or any Product Commercialization and Development Activity and (y) during any period of 12 consecutive months is reasonably expected to (1) result in payments or receipts (including royalty, licensing or similar payments) made to any Obligor or any of its

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Subsidiaries in an aggregate amount in excess of $2,000,000 or (2) require payments or expenditures (including royalty, licensing or similar payments) to be made by any Obligor or any of its Subsidiaries in an aggregate amount in excess of $2,000,000, in each case, other than any Contract with respect to the payment of shipping or transportation costs of any Product and (ii) any Contract the absence or termination of which would reasonably be expected to result in a Material Adverse Effect.

Material Indebtedness ” means, at any time, any Indebtedness of any Obligor to any other Person of the type described in clauses (i), (ii), (v), (vi), (vii) and (viii) of the definition thereof (excluding intercompany Indebtedness among Obligors and/or their Subsidiaries to the extent permitted hereunder), the outstanding principal amount of which exceeds $500,000 (or the Equivalent Amount in other currencies determined at the time of the incurrence of such Indebtedness).

Material Intellectual Property ” means (i) all Obligor Intellectual Property listed in Schedule 7.05(c) and (ii) all other Obligor Intellectual Property, whether currently owned or licensed or acquired, developed or otherwise licensed or obtained after the date hereof (a) the loss of which would have a Material Adverse Effect or (b) that has a fair market value in excess of $1,000,000.

Maturity Date ” means April 17, 2023.

Multiemployer Plan ” means any multiemployer plan, as defined in Section 4001(a)(3) of ERISA, to which any ERISA Affiliate incurs or otherwise has any obligation or liability, contingent or otherwise.

Net Cash Proceeds ” means, (i) with respect to any Casualty Event, the amount of cash proceeds received (directly or indirectly) from time to time by or on behalf of the Borrower or any such Subsidiary after deducting therefrom only (w) reasonable fees, costs and expenses related thereto incurred by the Borrower or such Subsidiary in connection therewith, (x) amounts required to be repaid on account of any Permitted Indebtedness or other obligations (other than the Obligations) required to be repaid as a result of such Casualty Event, (y) amounts required to be reserved in accordance with GAAP for indemnities and against liabilities associated with the property damaged, destructed or condemned in such Casualty Event and (z) Taxes (including transfer Taxes or net income Taxes) paid or payable in connection therewith; provided that amounts specified therein in respect of costs, expenses or repayments shall only be deducted from aggregate cash proceeds to the extent such amounts are (1) actually paid to a Person that is not an Affiliate of the Borrower or any of its Subsidiaries and (2) properly attributable to such Casualty Event.

Note ” means a promissory note, in substantially the form of Exhibit A hereto, executed and delivered by the Borrower to any Lender in accordance with Section 2.02.

NY UCC ” means the UCC as in effect from time to time in New York.

Obligations ” means, with respect to any Obligor, all amounts, obligations, liabilities, covenants and duties of every type and description owing by such Obligor to any Secured Party (including all Guaranteed Obligations and the Warrant Obligations), arising out of, under, or in

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connection wit h, any Loan Document, whether direct or indirect (regardless of whether acquired by assignment), absolute or contingent, due or to become due, whether liquidated or not, now existing or hereafter arising and however acquired, and whether or not evidenced b y any instrument or for the payment of money, including, without duplication, (i) if such Obligor is the Borrower, all Loans, (ii) all interest accruing under the Loan Documents, whether or not accruing after the filing of any petition in bankruptcy or aft er the commencement of any insolvency, reorganization or similar proceeding, and whether or not a claim for post-filing or post-petition interest is allowed in any such proceeding, and (iii) all other fees, expenses (including fees, charges and disbursemen t of counsel), interest, commissions, charges, costs, disbursements, indemnities and reimbursement of amounts paid and other sums, in each case, chargeable to such Obligor under any Loan Document.

Obligor Intellectual Property ” means, at any time of determination, Intellectual Property owned by any of the Obligors at such time including, without limitation, the Intellectual Property listed on Schedule 7.05(b).

Obligors ” means, collectively, the Borrower and the Subsidiary Guarantors and their respective successors and permitted assigns.

One-Month LIBOR ” means, with respect to any applicable Interest Period hereunder, the one-month London Interbank Offered Rate for deposits in Dollars, as determined by the Administrative Agent from the appropriate Bloomberg or Telerate page selected by the Administrative Agent (or any successor thereto or similar source reasonably determined by the Administrative Agent from time to time), which shall be that one-month London Interbank Offered Rate for deposits in Dollars in effect at approximately 11:00 a.m. (London, England time) two (2) Business Days prior to the first Business Day of such Interest Period rounded up to the nearest 1/16 of one percent (1%).  The Administrative Agent’s determination of interest rates shall be determinative in the absence of manifest error.

Organic Document ” means, for any Person, its certificate of incorporation, by-laws, certificate of partnership, partnership agreement, certificate of formation, limited liability agreement, operating agreement and all shareholder agreements, voting trusts and similar arrangements applicable to such Person’s Equity Interests.

Other Connection Taxes ” means, with respect to any Recipient, Taxes imposed as a result of a present or former connection between such Recipient and the jurisdiction imposing such Tax (other than connections arising from such Recipient having executed, delivered, become a party to, performed its obligations under, received payments under, received or perfected a security interest under, engaged in any other transaction pursuant to or enforced any Loan Document, or sold or assigned an interest in any Loan or Loan Document).

Other Taxes ” means all present or future stamp, court or documentary, intangible, recording, filing or similar Taxes that arise from any payment made under, from the execution, delivery, performance, enforcement or registration of, from the receipt or perfection of a security interest under, or otherwise with respect to, any Loan Document, except any such Taxes that are Other Connection Taxes imposed with respect to an assignment (other than an assignment made at the request of the Borrower pursuant to Section 5.03(h)).

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Participant has the meaning set forth in Section 14.05(e).

Participant Register ” has the meaning set forth in Section 14.05(e).

Patents ” means all patents and patent applications, including the inventions and improvements described and claimed therein together with the reissues, divisions, continuations, renewals, extensions and continuations in part thereof.

Payment Date ” means (i) the last day of each Interest Period and (ii) the Maturity Date; provided that, in the event any such day is not a Business Day, then the payment due on such day shall be payable on the next occurring Business Day.

Pay-Off Indebtedness ” means the Indebtedness listed on Schedule 7.13(a) that is identified as “Pay-Off Indebtedness”.

Pay-Off Letters ” means each payoff letter in respect of the Pay-Off Indebtedness, in form and substance reasonably satisfactory to the Administrative Agent.

PBGC ” means the United States Pension Benefit Guaranty Corporation referred to and defined in ERISA and any successor entity performing similar functions.

Perfection Certificate ” means the Collateral Questionnaire in substantially the form set forth in Exhibit I which shall be delivered pursuant to Section 6.01(k).

Permitted Acquisition ” means (i) the Acquisition contemplated on the Closing Date as set forth on Schedule 9.03 and (ii) any Acquisition by the Borrower or any of its Subsidiaries which either meet all of the conditions below or which is otherwise consented to by the Majority Lenders:

(a) immediately prior to, and after giving effect thereto, no Default or Event of Default shall have occurred and be continuing or would reasonably be expected to result therefrom;

(b) all transactions in connection therewith shall be consummated, in all material respects, in accordance with all applicable Laws, and in conformity in all material respects with all applicable Governmental Approvals;

(c) in the case of the Acquisition of any Equity Interests of any Person, all of such Equity Interests shall be owned one hundred percent (100%) by an Obligor, and the Borrower shall have taken or caused to be taken, as of the date such Equity Interests are acquired, all necessary actions to comply with Section 8.12(a), as applicable;

(d) in the case of the Acquisition of assets, all assets acquired shall be owned by an Obligor, and the Borrower shall have taken or caused to be taken, as of the date the assets are acquired, all necessary actions to comply with Section 8.12(a), as applicable;

(e) such Person (in the case of an Acquisition of Equity Interests) or assets (in the case of an Acquisition of assets or a division) shall be engaged or used, as the case

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may be, in substanti ally the same business or lines of business in which the Borrower and its Subsidiaries are engaged as of the Closing Date or a business reasonably related, incidental or complimentary thereto or a reasonable extension thereof or a business having a similar customer base;

(f) on a pro forma basis after giving effect to such Acquisition, the Borrower and its Subsidiaries shall be in compliance with the financial covenants set forth in Section 10;

(g) the aggregate consideration for all such Acquisitions does not exceed the sum of (x) $10,000,000 in cash in any fiscal year plus (y) any consideration in the form of Qualified Equity Interests;

(h) the Borrower shall have provided the Administrative Agent with at least ten (10) Business Days’ prior written notice of any such Acquisition, together with summaries, prepared in reasonable detail, of all due diligence conducted by or on behalf of the Borrower or the applicable Subsidiary prior to such Acquisition; provided that the Borrower shall not be required to provide any summary that includes trade secrets or would result in a loss of attorney-client privilege between the Borrower and its counsel;

(i) the Administrative Agent shall have received a certificate of a Responsible Officer of the Borrower (prepared in reasonable detail), certifying as to any contingent liabilities and, to the extent applicable, prospective research and development costs associated with the Person or assets being acquired; and

(j) all of the assets or Equity Interests acquired in connection with such Acquisition shall be of a U.S. Person.

Permitted Cash Equivalent Investments ” means (i) marketable direct obligations issued or unconditionally guaranteed by the United States or any agency or any State thereof having maturities of not more than one (1) year from the date of acquisition, (ii) commercial paper maturing no more than one (1) year after its creation and having the highest rating from either Standard & Poor’s Ratings Group or Moody’s Investors Service, Inc., (iii) time deposits with, or insured certificates of deposit or banker’s acceptances of, any commercial bank that (x) is organized under the laws of the United States or is the principal banking subsidiary of a bank holding company organized under the laws of the United States and is a member of the Federal Reserve System and (y) has combined capital and surplus of at least $1,000,000,000, in each case with maturities of not more than one (1) year from the date of acquisition, (iv) any money market funds at least ninety-five percent (95%) of the assets of which constitute investments of the type described in clauses (i), (ii) or (iii) above and (v) similar investments by Foreign Subsidiaries in jurisdictions outside the United States.

Permitted Indebtedness ” means any Indebtedness permitted under Section 9.01.

Permitted Liens ” means any Liens permitted under Section 9.02.

Permitted Priority Liens ” means Liens permitted under any of the clauses (b), (c), (d), (e), (f) or (i) of Section 9.02.

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Permitted Refinancing ” means, with respect to any Permitted Indebtedness, any extension, renewal, replacement or refinancing of such Indebtedness; provided that such extension, re newal, replacement or refinancing (i) shall not increase the outstanding principal amount of such Indebtedness except by accrued and unpaid interest and premiums thereon and fees and expenses associated with such extension, renewal, replacement or refinanc ing, (ii) contains terms relating to outstanding principal amount, amortization, maturity, collateral (if any) and subordination (if any), and other material terms taken as a whole no less favorable in any material respect to the Borrower and its Subsidiar ies or the Secured Parties than the terms of any agreement or instrument governing the Indebtedness being extended, renewed, replaced or refinanced, (iii) shall have an applicable interest rate or equivalent yield which does not exceed the interest rate or equivalent yield of the Indebtedness being extended, renewed, replaced or refinanced, (iv) shall not contain any new requirement to grant any Lien or to give any Guarantee that was not an existing requirement of the Indebtedness being extended, renewed, r eplaced or refinanced and (v) after giving effect to such extension, renewal, replacement or refinancing, no Default or Event of Default shall have occurred (or would reasonably be expected to occur) as a result thereof.

Person ” means any individual, corporation, company, voluntary association, partnership, limited liability company, joint venture, trust, unincorporated organization or Governmental Authority or other entity of whatever nature.

Prepayment Date ” has the meaning set forth in Section 3.04(a)(i).

“Prepayment Premium” means with respect to any prepayment of principal of the Loans referenced in Section 3.04(a) or (b) occurring (i) on or prior to the first anniversary of the Tranche A Term Loan Borrowing Date, an amount equal to eight percent (8%) of the aggregate outstanding principal amount of the Loans being prepaid, (ii) at any time after the first anniversary of the Tranche A Term Loan Borrowing Date and on or prior to the second anniversary of the Tranche A Term Loan Borrowing Date, an amount equal to seven percent (7%) of the aggregate outstanding principal amount of the Loans being prepaid; (iii) at any time after the second anniversary of the Tranche A Term Loan Borrowing Date and on or prior to the third anniversary of the Tranche A Term Loan Borrowing Date, an amount equal to six percent (6%) of the aggregate outstanding principal amount of the Loans being prepaid on such Prepayment Date, (iv) at any time after the third anniversary of the Tranche A Term Loan Borrowing Date and prior to the fourth anniversary of the Tranche A Term Loan Borrowing Date, an amount equal to five percent (5%) of the aggregate outstanding principal amount of the Loans being prepaid and (v) at any time after the fourth anniversary of the Tranche A Term Loan Borrowing Date and prior to the Maturity Date, an amount equal to four percent (4%) of the aggregate outstanding principal amount of the Loans being prepaid.

Prepayment Price ” has the meaning set forth in Section 3.04(a)(i).

Product ” means (i) those Devices set forth (and described in reasonable detail) on Schedule 2 attached hereto, and (ii) any current or future Device subject to any Product Commercialization and Development Activities of the Borrower or any of its Subsidiaries, including any such Device currently in development.

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Product Agreement ” means, with respect to any Product, any Contract, license, document, instrument, interest (equity or otherwise) or the like under which one or more Persons grants or receives (i) any right, title or interest with r espect to any Product Commercialization and Development Activities with respect to such Product, or (ii) any right to exclude any other Person from engaging in, or otherwise restricting any right, title or interest as to, any Product Commercialization and Development Activities with respect to such Product, including any Contract with suppliers, manufacturers, distributors, clinical research organizations, hospitals, group purchasing organizations, wholesalers, pharmacies or any other Person related to such entity.

Product Assets ” means, with respect to any Product, (i) any and all rights, title and interest of the Borrower or any of its Subsidiaries in any assets relating to such Product or any Product Commercialization and Development Activities with respect to such Product, (ii) all Product Related Information with respect to such Product or any related Product Commercialization and Development Activities, (iii) any Product Agreement related to such Product or any such Product Commercialization and Development Activities, (iv) any Intellectual Property, Regulatory Approvals and similar assets with respect to such Product or any such Product Commercialization and Development Activities, and (v) all rights, title and interests in any other property, tangible or intangible, manifesting or otherwise in respect of such Product or any such Product Commercialization and Development Activities, including, without limitation, inventory, accounts receivable or similar rights to receive money or payment pertaining thereto and all proceeds of the foregoing.

Product Authorizations ” means any and all Regulatory Approvals (including all applicable IDEs, Device Clearance Applications, supplements, amendments, pre- and post- approvals, governmental price and reimbursement approvals and approvals of applications for regulatory exclusivity), clearances, licenses, notifications, registrations or authorizations of any Regulatory Authority in each case necessary for the ownership, use or other commercialization of any Product or for any Product Commercialization and Development Activities with respect thereto in any country or jurisdiction, whether U.S. or non-U.S.

Product Commercialization and Development Activities ” means, with respect to any Product, any combination of research, development, manufacture, import, use, sale, licensing, storage, labeling, marketing, promotion, supply, distribution, testing, packaging, purchasing or other commercialization activities, receipt of payment in respect of any of the foregoing (including, without limitation, in respect of licensing, royalty or similar payments), or any similar or other activities the purpose of which is to commercially exploit such Product.

Product Related Information ” means, with respect to any Product, all books, records, lists, ledgers, files, manuals, Contracts, correspondence, reports, plans, drawings, data and other information of every kind (in any form or medium), and all techniques and other know-how, owned or possessed by the Borrower or any of its Subsidiaries that is necessary or required for any Product Commercialization and Development Activities relating to such Product, including (i) brand materials, packaging and other trade dress, customer targeting and other marketing, promotion and sales materials and information, referral, customer, supplier and other contact lists and information, product, business, marketing and sales plans, research, studies and reports, sales, maintenance and production records, training materials and other marketing, sales and

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prom otional information, (ii) clinical data, information included or supporting any Product Authorization or other Regulatory Approval, any regulatory filings, updates, notices and correspondence (including adverse event and other pharmacovigilance and other p ost-marketing reports and information, etc.), technical information, product development and operational data and records, and all other documents, records, files, data and other information relating to product development, manufacture and use, (iii) litig ation and dispute records, and accounting records; (iv) all documents, records and files relating to Intellectual Property, including all correspondence from and to third parties (including Intellectual Property counsel and patent, trademark and other inte llectual property registries, including the U.S. Patent & Trademark Office), and (v) all other information, techniques and know-how necessary or required in connection with the Product Commercialization and Development Activities for any Product.

Product Revenue ” means, for any relevant fiscal period, the consolidated total revenues of the Borrower and its Subsidiaries related to the sale of products or provision of services (including recurring royalties and license fees related to such sale of products and provision of services) for such fiscal period generated from Product Commercialization and Development Activities, as recognized on the income statement of the Borrower and its Subsidiaries, determined on a consolidated basis in accordance with GAAP, but excluding any one-time payments (including one-time payments of license fees, milestones, royalties and other similar one-time payments) not related to the sale of products or provision of services.

Prohibited Payment ” means any bribe, rebate, payoff, influence payment, kickback or other payment or gift of money or anything of value (including meals or entertainment) to any officer, employee or ceremonial office holder of any government or instrumentality thereof, political party or supra-national organization (such as the United Nations), any political candidate, any royal family member or any other person who is connected or associated personally with any of the foregoing that is prohibited under any applicable Law for the purpose of influencing any act or decision of such payee in his official capacity, inducing such payee to do or omit to do any act in violation of his lawful duty, securing any improper advantage or inducing such payee to use his influence with a government or instrumentality thereof to affect or influence any act or decision of such government or instrumentality.

Proportionate Share ” means, with respect to any Lender, the percentage obtained by dividing (i) the sum of the Commitment (or, if the Commitments are terminated, the outstanding principal amount of the Loans) of such Lender then in effect by (ii) the sum of the Commitments (or, if the Commitments are terminated, the outstanding principal amount of the Loans) of all Lenders then in effect.

Qualified Equity Interest ” means, with respect to any Person, any Equity Interest of such Person that is not a Disqualified Equity Interest.

Real Property Security Documents ” means any Landlord Consents, Bailee Letters, any mortgage or deed of trust or any other real property security document executed or required hereunder to be executed by any Obligor and granting a security interest in real property owned or leased (as tenant) by any Obligor in favor of the Secured Parties, but specifically excluding leasehold mortgages.

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Recipient ” means any Lender or the Administrative Agent.

Reference Rate ” means One-Month LIBOR; provided that, if One-Month LIBOR can no longer be determined by the Administrative Agent (in its sole discretion) or any Governmental Authority having jurisdiction over the quotation or determination of the London Interbank Offered Rates declares that it will no longer supervise or sanction such rates for purposes of interest rates on loans, then the Reference Rate for purposes hereof and of each other Loan Document shall be a comparable rate as may be selected by the Administrative Agent in its sole discretion.

Referral Source ” has the meaning set forth in Section 7.07(b).

Register ” has the meaning set forth in Section 14.05(d).

Regulation T ” means Regulation T of the Board of Governors of the Federal Reserve System, as amended.

Regulation U ” means Regulation U of the Board of Governors of the Federal Reserve System, as amended.

Regulation X ” means Regulation X of the Board of Governors of the Federal Reserve System, as amended.

Regulatory Approval ” means any Governmental Approval, whether U.S. or non-U.S., relating to any Product or any Product Commercialization and Development Activities related to such Product, including any Product Authorizations with respect thereto.

Regulatory Authority ” means any Governmental Authority, whether U.S. or non-U.S., that has regulatory or supervisory oversight with respect to any Product or any Product Commercialization and Development Activities relating to any Product, including the FDA and all equivalent Governmental Authorities, whether U.S. or non-U.S.

Related Fund ” means, with respect to any Lender, a fund which is managed or advised by the same investment manager or investment adviser as such Lender or, if it is managed by a different investment manager or investment adviser, a fund whose investment manager or investment adviser is an Affiliate of the investment manager or investment adviser of such Lender.

Related Parties ” has the meaning set forth in Section 14.16.

Resignation Effective Date ” has the meaning set forth in Section 13.06(a).

Responsible Officer ” of any Person means each of the president, chief executive officer, chief financial officer and similar officer of such Person.

Restricted Payment ” means any dividend or other distribution (whether in cash, securities or other property) with respect to any Equity Interests of the Borrower or any of its Subsidiaries, or any payment (whether in cash, securities or other property), including any

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sinking fund or similar dep osit, on account of the purchase, redemption, retirement, acquisition, cancellation or termination of any such shares of capital stock of the Borrower or any of its Subsidiaries or any option, warrant or other right to acquire any such shares of capital st ock of the Borrower or any of its Subsidiaries.

Restrictive Agreement ” means any indenture, agreement, instrument or other arrangement that prohibits, restricts or imposes any condition upon (i) the ability of the Borrower or any other Obligor to create, incur or permit to exist any Lien (other than Permitted Liens) upon any of its property or assets (other than (x) customary provisions in contracts (including without limitation leases and licenses of Intellectual Property) restricting the assignment thereof or, in the case of any lease or license, the sublease or sublicense or other disposition of the applicable leased or licensed property, (y) restrictions or conditions imposed by any agreement governing secured Permitted Indebtedness permitted under Section 9.01(g), to the extent that such restrictions or conditions apply only to the property or assets securing such Indebtedness and (z) restrictions in agreements related to any Asset Sale to the extent such Asset Sale would be a permitted Asset Sale under this Agreement), or (ii) the ability of any Subsidiary to pay dividends or other distributions with respect to any shares of its capital stock or to make or repay loans or advances to the Borrower or any other Obligor or the ability of any Subsidiary to guarantee Indebtedness of the Borrower or any other Obligor to the extent such guarantee is required by Section 8.12.

Sanction ” means any international economic sanction administered or enforced by the United States Government (including, without limitation, OFAC), the United Nations Security Council, the European Union or its Member States, Her Majesty’s Treasury or other similar relevant sanctions authority.

Scheduled Indebtedness ” means the Pay-Off Indebtedness and Indebtedness of the type described in clauses (i), (ii), (v), (vi) and (vii) of the definition thereof.

SEC ” means the U.S. Securities and Exchange Commission.

Secured Parties ” means the Lenders, the Administrative Agent, each other Indemnified Party, any other holder of any Obligation, and any of their respective permitted transferees or assigns.

Securities Act ” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

Security Agreement ” means the Security Agreement, dated as of the Closing Date, among the grantors party thereto and the Administrative Agent, granting a security interest in the Obligors’ personal property in favor of the Administrative Agent.

Security Documents ” means, collectively, the Security Agreement, the Swedish Pledge Agreement, each Short-Form IP Security Agreement, each Real Property Security Document and each other security document, control agreement or financing statement required or recommended to perfect Liens in favor of the Secured Parties for purposes of securing the Obligations.

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Securities Account ” has the meaning given to it in Section 8-501(a) of the NY UCC.

Short-Form IP Security Agreements ” means short-form patent, trademark or copyright (as the case may be) security agreements, substantially in the forms of Exhibits J, K and L to this Agreement, as applicable, entered into by one (1) or more Obligors in favor of the Administrative Agent for the benefit of each Secured Party.

Solvent ” means, with respect to any Person at any time, that (i) the present fair saleable value of the property of such Person is greater than the total amount of liabilities (including contingent liabilities) of such Person, (ii) the present fair saleable value of the property of such Person is not less than the amount that will be required to pay the probable liability of such Person on its debts as they become absolute and matured and (iii) such Person has not incurred and does not intend to, and does not believe that it will, incur debts or liabilities beyond such Person’s ability to pay such debts and liabilities as they mature.

Subordinated Indebtedness ” means any Indebtedness which is subject to a subordination agreement with Administrative Agent, in form and substance satisfactory to Administrative Agent in its sole discretion.

Subsidiary ” means, with respect to any Person (the “ parent ”) at any date, any corporation, limited liability company, partnership, association or other entity the accounts of which would be consolidated with those of the parent in the parent’s consolidated financial statements if such financial statements were prepared in accordance with GAAP as of such date, as well as any other corporation, limited liability company, partnership, association or other entity of which securities or other ownership interests representing more than fifty percent (50%) of the equity or more than fifty percent (50%) of the ordinary voting power or, in the case of a partnership, more than fifty percent (50%) of the general partnership interests are, as of such date, directly or indirectly, owned, controlled or held.

Subsidiary Guarantors means each Domestic Subsidiary of the Borrower identified under the caption “SUBSIDIARY GUARANTORS” on the signature pages hereto and each Domestic Subsidiary of the Borrower that becomes, or is required to become, a “Subsidiary Guarantor” after the date hereof pursuant to Section 8.12(a).

Swedish Pledge Agreement ” means the Share Pledge Agreement relating to certain shares in CareDx International AB, dated as of the Closing Date between the Borrower and the Administrative Agent.

Sweep Agreement ” has the meaning set forth in Section 8.16(c).

Taxes ” means all present or future taxes, levies, imposts, duties, deductions, withholdings (including backup withholding), assessments, fees or other charges imposed by any Governmental Authority, including any interest, additions to tax or penalties applicable thereto.

Technical Information ” means all trade secrets and other proprietary or confidential information, public information, non-proprietary know-how, any information of a scientific, technical, or business nature in any form or medium, standards and specifications, conceptions, ideas, innovations, discoveries, Invention disclosures, all documented research, developmental,

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demonstration or engin eering work and all other information, data, plans, specifications, reports, summaries, experimental data, manuals, models, samples, know-how, technical information, systems, methodologies, computer programs, information technology and any other informatio n.

Title IV Plan ” means an employee benefit plan (as defined in Section 3(3) of ERISA) other than a Multiemployer Plan (i) that is or within the last six years was maintained or sponsored by any Obligor or any ERISA Affiliate thereof or to which any Obligor or any ERISA Affiliate thereof within the last six years made, or was obligated to make, contributions, and (ii) that is or was subject to Section 412 of the Code, Section 302 of ERISA or Title IV of ERISA.

Trademarks ” means all trade names, trademarks and service marks, logos, trademark and service mark registrations, and applications for trademark and service mark registrations, including all renewals of trademark and service mark registrations and goodwill of the business connected with the use thereof.

Tranche A Closing Fee ” has the meaning set forth in Section 3.06.

Tranche A Term Loan ” means each loan advanced by a Lender pursuant to Section 2.01(a).  For purposes of clarification, any calculation of the aggregate outstanding principal amount of the Tranche A Term Loan on any date of determination shall mean the aggregate principal amount of the Tranche A Term Loan made pursuant to Section 2.01(a) that has not yet been repaid as of such date.

Tranche A Term Loan Borrowing Date ” means with respect to the Tranche A Term Loan, the Business Day set forth in the Closing Date Certificate delivered by the Borrower to the Administrative Agent pursuant to Section 2.01(a) provided that all conditions set forth in Section 6.1 have been satisfied or waived by the Majority Lenders.

Tranche A Term Loan Commitment ” means the commitment of a Lender to make or otherwise fund a Tranche A Term Loan and “ Tranche A Term Loan Commitments ” means such commitments of all Lenders in the aggregate.  The amount of each Lender’s Tranche A Term Loan Commitment, if any, is set forth on Schedule 1.  The aggregate amount of the Tranche A Term Loan Commitments as of the Closing Date is $25,000,000.

Tranche A Warrant ” means the warrant to be delivered to the Administrative Agent pursuant to Section 6.01 on the Closing Date, that, among other things, grants the holder thereof the right to purchase the number of shares of common stock of the Borrower as indicated on the Warrant Shares table on Schedule 1, as the Tranche A Warrant may be amended, replaced or otherwise modified pursuant to the terms thereof.

Tranche B Closing Fee ” has the meaning set forth in Section 3.06.

Tranche B Term Loan ” means each loan advanced by a Lender pursuant to Section 2.01(b).  For purposes of clarification, any calculation of the aggregate outstanding principal amount of the Tranche B Term Loan on any date of determination shall mean the aggregate principal amount of the Tranche B Term Loan made pursuant to Section 2.01(b) that has not yet been repaid as of such date.

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Tranche B Term Loan Borrowing Date ” means with respect to the Tranche B Term Loan, the Business Day set forth in the Borrowing Notice delivered by the Borrower to the Administrative Agent pursuant to Section 2.01(b) provided that all condit ions set forth in Section 6.2 have been satisfied or waived by the Majority Lenders.

Tranche B Term Loan Commitment ” means the commitment of a Lender to make or otherwise fund a Tranche B Term Loan and “ Tranche B Term Loan Commitments ” means such commitments of all Lenders in the aggregate.  The amount of each Lender’s Tranche B Term Loan Commitment, if any, is set forth on Schedule 1.  The aggregate amount of the Tranche B Term Loan Commitments as of the Closing Date is $10,000,000.

Tranche B Term Loan Commitment Termination Date ” means the one (1) year anniversary of the Closing Date.

Tranche B Warrant ” means the warrant to be delivered to the Administrative Agent pursuant to Section 6.02 on the Tranche B Term Loan Borrowing Date, that, among other things, grants the holder thereof the right to purchase the number of shares of common stock of the Borrower as indicated on the Warrant Shares table on Schedule 1, as the Tranche B Warrant may be amended, replaced or otherwise modified pursuant to the terms thereof, and which shall be in substantially the same form as the Tranche A Warrant.

Transactions ” means the negotiation, preparation, execution, delivery and performance by each Obligor of this Agreement and the other Loan Documents to which such Obligor is (or is intended to be) a party, the making of the Loans hereunder, and all other transactions contemplated pursuant to this Agreement and the other Loan Documents.

UCC ” means, with respect to any applicable jurisdictions, the Uniform Commercial Code as in effect in such jurisdiction, as may be modified from time to time.

United States ” or “ U.S. ” means the United States of America, its fifty (50) states and the District of Columbia.

U.S. Person ” means a “United States person” within the meaning of Section 7701(a)(30) of the Code.

U.S. Tax Compliance Certificate ” has the meaning set forth in Section 5.03(f)(ii)(B).

Warrants ” means, collectively, the Tranche A Warrant and the Tranche B Warrant.

Warrant Obligations ” means all Obligations of the Borrower arising out of, under or in connection with the Warrants.

Withdrawal Liability ” means, at any time, any liability incurred (whether or not assessed) by any ERISA Affiliate and not yet satisfied or paid in full at such time with respect to any Multiemployer Plan pursuant to Section 4201 of ERISA.

Withholding Agent means the Borrower, any Obligor and the Administrative Agent.

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Write-Down and Conversion Powers ” means, with respect to any EEA Resolution Authority, the write-down and conversion powers of suc h EEA Resolution Authority from time to time under the Bail-In Legislation for the applicable EEA Member Country, which write-down and conversion powers are described in the EU Bail-In Legislation Schedule.

Section 1.02. Accounting Terms and Principles

.  Unless otherwise specified, all accounting terms used in each Loan Document shall be interpreted, and all accounting determinations and computations thereunder (including under Section 10 and any definitions used in such calculations) shall be made, in accordance with GAAP; provided that, for purposes of determining compliance with any covenant contained in Section 9 or the existence of any Default or Event of Default under Section 11, in determining whether any lease is required to be accounted for as a capital lease or an operating lease, such determination shall be made based on GAAP as in effect on the date of this Agreement.  Unless otherwise expressly provided, all financial covenants and defined financial terms shall be computed on a consolidated basis for the Borrower and its Subsidiaries, in each case, without duplication.

Section 1.03. Interpretation

.  For all purposes of this Agreement, except as otherwise expressly provided herein or unless the context otherwise requires,

(a) the terms defined in this Agreement include the plural as well as the singular and vice versa;

(b) words importing gender include all genders;

(c) any reference to a Section, Annex, Schedule or Exhibit refers to a Section of, or Annex, Schedule or Exhibit to, this Agreement;

(d) any reference to “this Agreement” refers to this Agreement, including all Annexes, Schedules and Exhibits hereto, and the words herein, hereof, hereto and hereunder and words of similar import refer to this Agreement and its Annexes, Schedules and Exhibits as a whole and not to any particular Section, Annex, Schedule, Exhibit or any other subdivision;

(e) references to days, months and years refer to calendar days, months and years, respectively;

(f) all references herein to “include” or “including” shall be deemed to be followed by the words “without limitation”;

(g) the word “from” when used in connection with a period of time means “from and including” and the word “until” means “to but not including”;

(h) where any provision in this Agreement or any other Loan Document refers to an action to be taken by any Person, or an action which such Person is prohibited from taking, such provision shall be applicable whether such action is taken directly or indirectly;

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(i) references to any Lien granted or created hereunder or pursuant to any other Loan Document securing a ny Obligations shall be deemed to be a Lien for the benefit of the Secured Parties;

(j) the words “asset” and “property” shall be construed to have the same meaning and effect and to refer broadly to any and all assets and properties, whether tangible or intangible, real or personal, including cash, securities, rights under contractual obligations and permits and any right or interest in any such assets or property except where otherwise noted herein;

(k) accounting terms not specifically defined herein (other than “property” and “asset”) shall be construed in accordance with GAAP;

(l) the word “will” shall be construed to have the same meaning as the word “shall”; and

(m) a Schedule shall refer to those Schedules provided as of the date hereof and as may be further updated on the Tranche B Term Loan Borrowing Date (which updates, for the avoidance of doubt, shall be acceptable to the Administrative Agent unless such updates reflect an item that is otherwise prohibited under this Agreement on the date thereof).

Unless otherwise expressly provided herein, references to organizational documents, agreements (including the Loan Documents) and other contractual instruments shall be deemed to include all subsequent amendments, restatements, extensions, supplements and other modifications thereto permitted by the Loan Documents.

Section 1.04. Changes to GAAP

.  Subject to Section 1.02, if, after the date hereof, any change occurs in GAAP or in the application thereof and such change would cause any amount required to be determined for the purposes of the covenants to be maintained or calculated pursuant to Section 8, 9 or 10 to be materially different than the amount that would be determined prior to such change, then:

(a) the Borrower will provide a detailed notice of such change (an “ Accounting Change Notice ”) to the Administrative Agent within thirty (30) days after a Responsible Officer’s learning that such change would so impact the covenants and calculations hereunder;

(b) either the Borrower or the Administrative Agent may indicate within ninety (90) days following the date of the Accounting Change Notice that they wish to revise the method of calculating such covenants or amend any such amount, in which case the parties will in good faith attempt to agree upon a revised method for calculating the financial covenants;

(c) until the Borrower and the Administrative Agent have reached agreement on such revisions, such covenants or amounts as set forth herein shall remain in effect and will be determined without giving effect to such change;

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(d) if no party elects to revise the method of calculating the covenants or amounts, then the covenants or amounts will not be revised and will be determined in accordance with GAAP without giving effect to such change; and

(e) any Event of Default arising as a result of such change which is cured by operation of this Section 1.04 shall be deemed to be of no effect ab initio .

SECTION 2.

The Commitments and the Loans.

Section 2.01. Loans.

(a) Tranche A Term Loan .

(i) On the Tranche A Term Loan Borrowing Date, subject to the terms and conditions set forth in Section 6.01, each Lender, severally and not jointly, agrees to provide its share of the Tranche A Term Loan to the Borrower on the Tranche A Term Loan Borrowing Date in Dollars in a principal amount not to exceed such Lender’s Tranche A Term Loan Commitment.  No Lender shall have an obligation to make a Tranche A Term Loan in excess of such Lender’s Tranche A Term Loan Commitment.

(ii) On the Tranche A Term Loan Borrowing Date, the Borrower may request one borrowing under the Tranche A Term Loan Commitment which shall be in an amount equal to $15,000,000.  Subject to the terms and conditions of this Agreement (including Section 6.01), the Borrower shall deliver to the Administrative Agent a fully executed Borrowing Notice no later than 5 p.m. (New York City time) at least one (1) Business Day in advance of the proposed Tranche A Term Loan Borrowing Date.  The Borrowing Notice shall indicate the amount of the Tranche A Term Loan the Borrower elects to borrow on the proposed Tranche A Term Loan Borrowing Date.

(iii) Subject to Section 3.04, all amounts owed hereunder with respect to the Tranche A Term Loan shall be paid in full no later than the Maturity Date.  Each Lender’s Tranche A Term Loan Commitment shall terminate immediately and without further action on the Tranche A Term Loan Borrowing Date after giving effect to the funding of such Lender’s Tranche A Term Loan Commitment on such date.

(b) Tranche B Term Loan .

(i) Prior to the Tranche B Term Loan Commitment Termination Date, subject to the terms and conditions set forth in Section 6.02, each Lender, severally and not jointly, agrees to provide its share of the Tranche B Term Loan to the Borrower on the Tranche B Term Loan Borrowing Date in Dollars in a principal amount equal to such Lender’s Tranche B Term Loan Commitment.  No Lender shall have an obligation to make a Tranche B Term Loan in excess of such Lender’s Tranche B Term Loan Commitment.

(ii) Subject to the terms and conditions of this Agreement (including Section 6.02), the Borrower shall deliver to the Administrative Agent a fully executed

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Borrowing Notice no later than 5 p.m. (New York City time) at least one (1) Business Day in advance of the proposed Tranche B Term Loan Borrowing Date.

(iii) The Borrower may request one borrowing under the Tranche B Term Loan Commitment which shall be on the Tranche B Term Loan Borrowing Date.  All amounts owed hereunder with respect to the Tranche B Term Loan shall be paid in full no later than the Maturity Date.  Each Lender’s Tranche B Term Loan Commitment shall terminate immediately and without further action on the Tranche B Term Loan Borrowing Date after giving effect to the funding of such Lender’s Tranche B Term Loan Commitment on such date.

(c) No amounts paid or prepaid with respect to any Loan may be reborrowed.  Any term or provision hereof (or of any other Loan Document) to the contrary notwithstanding, Loans made to the Borrower will be denominated solely in Dollars and will be repayable solely in Dollars and no other currency.

Section 2.02. Notes

.  If requested by any Lender, the Loan of such Lender shall be evidenced by one or more Notes.  If so requested, the Borrower shall prepare, execute and deliver to the Administrative Agent such promissory note(s) payable to the Lenders (or, if requested by the Lenders, to the Lenders and their registered permitted assigns) substantially in the form attached hereto as Exhibit A.

Section 2.03. Use of Proceeds

.  The Borrower shall use the proceeds of the Loans solely (a) for general corporate purposes, including, without limitation, business development and licensing purposes, (b) to refinance the Pay-Off Indebtedness and (c) to pay the fees, costs and expenses associated with the Transactions.

SECTION 3.

Payments of Principal and Interest.

Section 3.01. Repayments and Prepayments Generally; Application

.  (a) There will be no scheduled amortization payments of principal on the Loans prior to the third (3rd) anniversary of the Tranche A Term Loan Borrowing Date.

(b) Commencing with the Payment Date occurring immediately after the third (3rd) anniversary of the Tranche A Term Loan Borrowing Date and on each Payment Date occurring thereafter, the Borrower shall make a scheduled amortization payment of principal on the Loans in an amount equal to 1.50% of the aggregate principal amount of the Loans outstanding under this Agreement on the third (3rd) anniversary of the Tranche A Term Loan Borrowing Date.

(c) Any term or provision hereof to the contrary notwithstanding, on the Maturity Date the Borrower shall repay the entire remaining outstanding balance of the Loans in full in cash.

(d) The Borrower agrees that the Loans, and any fees or interest accrued or accruing thereon, shall be repaid and prepaid solely in Dollars pursuant to the terms of this Section 3.  Except as otherwise provided in this Agreement, each payment (including each repayment and

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prepay ment) by the Borrower will be deemed to be made ratably in accordance with the Lenders’ Proportionate Share.

Section 3.02. Interest.

(a) Interest Generally .  The outstanding principal amount of the Loans, as well as the amount of all other outstanding Obligations, shall accrue interest at the Interest Rate.

(b) Default Interest .  Notwithstanding the foregoing, upon the occurrence and during the continuance of any Event of Default, the Applicable Margin shall increase automatically by three percent (3.00%) per annum (the Interest Rate, as increased pursuant to this Section 3.02(b), being the “ Default Rate ”).  If any Obligation (other than any Warrant Obligation) is not paid when due under any applicable Loan Document (after giving effect to any applicable grace period), the amount thereof shall accrue interest at the Default Rate.

(c) Interest Payment Dates .  Accrued interest on the Loans shall be payable in cash and in arrears on each Payment Date with respect to the most recently completed Interest Period, and upon the payment or prepayment of the Loans (on the principal amount being so paid or prepaid); provided that interest payable at the Default Rate shall also be payable from time to time on demand by the Administrative Agent.

(d) Maximum Rate .  Notwithstanding any other provision of this Agreement, in no event will any interest or rates referred to herein exceed the maximum interest rate permitted by applicable law.  If such maximum interest rate would be exceeded by the terms hereof, the rates of interest payable hereunder will be reduced to the extent necessary so that such rates (together with any fees or other amounts which are construed by a court of competent jurisdiction to be interest or in the nature of interest) equal the maximum interest rate permitted by applicable law, and any overpayment of interest received by the Lenders before such rates are so construed will be applied, forthwith after determination of such overpayment, to pay all then outstanding interest, and thereafter to pay outstanding principal.

Section 3.03. [Reserved].

Section 3.04. Prepayments; Prepayment Premium.

(a) Optional Prepayments .  (i) Subject to prior written notice pursuant to clause (ii) below, the Borrower shall have the right to optionally prepay, in whole or in part, the outstanding principal amount of the Loans on any Business Day (a “ Prepayment Date ”) for an aggregate amount equal to the sum of (x) the aggregate principal amount of the Loans being prepaid, (y) the applicable Prepayment Premium on the principal amount of the Loans being prepaid and (z) any accrued but unpaid interest on the principal amount of the Loans being prepaid (such aggregate amount, the “ Prepayment Price ”).

(ii) A notice of optional prepayment shall be effective only if received by the Administrative Agent not later than 2:00 p.m. (Eastern time) on a date not less than one (1) Business Day prior to the proposed Prepayment Date.  Each notice of optional prepayment (x) shall specify the Prepayment Price and the principal amount to be prepaid, as well as the

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Prepayment Date and (y) may be conditiona l or contingent upon any event, including, but not limited to, a refinancing of the Loans.

(b) Mandatory Prepayments .  (i) Subject to the proviso below, upon the occurrence of any Casualty Event, the Borrower shall make a mandatory prepayment of the Loans in an aggregate amount equal to the sum of (x) one hundred percent (100%) of the Net Cash Proceeds received by the Borrower or any other Obligor as a result of such Casualty Event, (y) the applicable Prepayment Premium on the principal amount of the Loans being prepaid and (z) any accrued but unpaid interest on such principal amount of the Loans being prepaid; provided that so long as no Default or Event of Default has occurred and is continuing at the time the Borrower or any Obligor shall have received such Net Cash Proceeds, if, within five (5) Business Days following the occurrence of any such Casualty Event, a Responsible Officer of the Borrower may deliver to the Administrative Agent a notice (each, a “ Casualty Event Reinvestment Notice ”) to the effect that the Borrower or applicable Subsidiary intends to apply the Net Cash Proceeds from such Casualty Event to acquire, replace or rebuild the property subject to such Casualty Event or to the cost of purchase or construction of other assets useful in the business of the Borrower or its Subsidiaries, then such Net Cash Proceeds of such Casualty Event may be applied for such purpose in lieu of such mandatory prepayment, provided further that, in the event that Net Cash Proceeds have not been so applied within one hundred eighty (180) days following the occurrence of such Casualty Event, the Borrower shall make a mandatory prepayment of the Loans in an aggregate amount equal to the sum of (A) one hundred percent (100%) of the unused balance of such Net Cash Proceeds received by the Borrower or any other Obligor as a result of such Casualty Event, (B) the applicable Prepayment Premium on the principal amount of the Loans being prepaid and (C) any accrued but unpaid interest on such principal amount of the Loans being prepaid, provided, further, that to the extent that the property subject to the Casualty Event is Collateral, then any such acquired, replaced, repaired, purchased or constructed property shall be Collateral in which the Administrative Agent, for the benefit of the Lenders, has been granted a security interest under the Security Documents.

(c) Prepayment Premium .  Without limiting the foregoing, whenever the Prepayment Premium is in effect and payable pursuant to the terms hereof, such premium shall be payable on all payments and prepayments of the Loans, whether as a result of clause (a) or (b) above in this Section 3.04, acceleration or otherwise.

(d) Application .  Proceeds of any prepayment made pursuant to clauses (a) or (b) above shall be applied in the following order of priority, with proceeds being applied to a succeeding level of priority only if amounts owing pursuant to the immediately preceding level of priority have been paid in full in cash:

(i) first , to the payment of any unpaid costs or expenses referred to in Section 14.03 then due and owing;

(ii) second , to the payment of any accrued and unpaid interest and any fees then due and owing;

(iii) third , to the payment of unpaid principal of the Loans;

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(iv) fourth , to the payment of any Prepayment Premium then due and paya ble;

(v) fifth , to the payment of any Exit Fee then due and payable pursuant to Section 3.05; and

(vi) sixth , to the Borrower or such other Persons as may lawfully be entitled to or directed by the Borrower to receive the remainder.

Section 3.05. Exit Fee

.  On the Maturity Date or, if earlier, the date when all principal of the outstanding Loans is paid in full or becomes due and payable in full (whether as a result of acceleration, mandatory prepayment, voluntary prepayment or repayment, scheduled amortization or otherwise), the Borrower will pay to the Administrative Agent (for the benefit of the Lenders) a fully-earned and nonrefundable exit fee equal to three percent (3.00%) of the principal amount of the Loans actually borrowed under this Agreement (the “ Exit Fee ”).  Upon receipt of payment from the Borrower, the Administrative Agent will promptly thereafter distribute like funds relating to any such payment to the Lenders pro rata on the basis of each Lender’s Proportionate Share.

Section 3.06. Closing Fees

.  On the Tranche A Term Loan Borrowing Date, the Borrower shall pay to the Administrative Agent out of the proceeds of the Tranche A Term Loan a non- refundable fee in the amount equal to 1.75% of the principal amount of the Tranche A Term Loan advanced by the Lenders on such date in excess of $15,000,000 (if any) (the “ Tranche A Closing Fee ”).  On the Tranche B Term Loan Borrowing Date, the Borrower shall pay to the Administrative Agent out of the proceeds of the Tranche B Term Loan a non-refundable fee in the amount equal to 1.75% of the principal amount of the Tranche B Term Loan advanced by the Lenders on such date (the “ Tranche B Closing Fee ”).  Payment of the Tranche A Closing Fee and the Tranche B Closing Fee shall be in addition to such fees, costs and expenses due and payable pursuant to Section 14.03.  Upon receipt of payment from the Borrower, the Administrative Agent will promptly thereafter distribute like funds relating to any such payment to the Lenders pro rata on the basis of each Lender’s Proportionate Share.

SECTION 4.

Payments, Etc.

Section 4.01. Payments.

(a) Payments Generally .  Each payment of principal, interest and other amounts to be made by the Obligors under this Agreement or any other Loan Document shall be made (i) in Dollars, in immediately available funds, without deduction, set off or counterclaim, to the deposit account of the Administrative Agent (for the benefit of the Lenders) designated by the Administrative Agent by notice to the Borrower and (ii) not later than 2:00 p.m. (Eastern time) on the date on which such payment is due (each such payment made after such time on such due date shall be deemed to have been made on the next succeeding Business Day).

(b) Application of Payments .  All such payments referenced in clause (a) above shall be applied as set forth in Section 3.04(d) above.

(c) Non-Business Days .  If the due date of any payment under this Agreement (whether in respect of principal, interest, fees, costs or otherwise) would otherwise fall on a day

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that is not a Business Day, such date shall be extended to the next succeeding Busi ness Day, and, in the case of any payment accruing interest, interest thereon shall be payable for the period of such extension.

Section 4.02. Computations

.  All computations of interest and fees hereunder shall be computed on the basis of a year of three hundred and sixty (360) days and actual days elapsed during the period for which payable.

Section 4.03. Set-Off.

(a) Set-Off Generally .  Upon the occurrence and during the continuance of any Event of Default, the Administrative Agent, each of the Lenders and each of their Affiliates is hereby authorized at any time and from time to time, to the fullest extent permitted by law, to set off and apply any and all deposits (general or special, time or demand, provisional or final) at any time held and other indebtedness at any time owing by any Lender and any of their Affiliates to or for the credit or the account of any Obligor against any and all of the Obligations, whether or not such Person shall have made any demand and although such obligations may be unmatured.  Any Person exercising rights of set off hereunder agrees promptly to notify the Borrower after any such set-off and application, provided that the failure to give such notice shall not affect the validity of such set-off and application.  The rights of the Lenders and each of their Affiliates under this Section 4.03 are in addition to other rights and remedies (including other rights of set-off) that such Persons may have.

(b) Exercise of Rights Not Required .  Nothing contained in Section 4.03(a) shall require the Administrative Agent, any Lender or any of their Affiliates to exercise any such right or shall affect the right of such Persons to exercise, and retain the benefits of exercising, any such right with respect to any other indebtedness or obligation of any Obligor.

SECTION 5.

Yield Protection, Etc.

Section 5.01. Additional Costs.

(a) Change in Law Generally .  If, on or after the date hereof, the adoption of any Law, or any change in any Law, or any change in the interpretation or administration thereof by any court or other Governmental Authority charged with the interpretation or administration thereof, or compliance by any Lender (or its lending office) with any request or directive (whether or not having the force of law) of any such Governmental Authority, shall impose, modify or deem applicable any reserve (including any such requirement imposed by the Board of Governors of the Federal Reserve System), special deposit, contribution, insurance assessment or similar requirement, in each case that becomes effective after the date hereof, against assets of, deposits with or for the account of, or credit extended by, a Lender (or its lending office) or shall impose on a Lender (or its lending office) any other condition affecting the Loans or the Commitment, and the result of any of the foregoing is to increase the cost to such Lender of making or maintaining the Loans, or to reduce the amount of any sum received or receivable by such Lender under this Agreement or any other Loan Document (other than the Warrants), or subject any Lender to any Taxes on its Loan, Commitment or other obligations, or its deposits, reserves, other liabilities or capital (if any) attributable thereto by an amount reasonably deemed

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by such Lender in good faith to be material (other than (i) Indemnified Taxes, (ii) Taxes described in clauses (ii) through (iv) of the definition of “Excluded Taxes” and (iii) Connection Income Taxes), then the Borrower shall pay to such Lender on demand such additional amount or amounts as will compensate such Lender for such increased cost or reduction.

(b) Change in Capital Requirements .  If a Lender shall have determined that, on or after the date hereof, the adoption of any applicable Law regarding capital adequacy, or any change therein, or any change in the interpretation or administration thereof by any Governmental Authority charged with the interpretation or administration thereof, or any request or directive regarding capital adequacy (whether or not having the force of law) of any such Governmental Authority, in each case that becomes effective after the date hereof, has or would have the effect of reducing the rate of return on capital of a Lender (or its parent) as a consequence of a Lender’s obligations hereunder or the Loans to a level below that which a Lender (or its parent) could have achieved but for such adoption, change, request or directive by an amount reasonably deemed by it to be material, then the Borrower shall pay to such Lender on demand such additional amount or amounts as will compensate such Lender (or its parent) for such reduction.

(c) Notification by Lender .  Each Lender will promptly notify the Borrower of any event of which it has knowledge, occurring after the date hereof, which will entitle such Lender to compensation pursuant to this Section 5.01.  Before giving any such notice pursuant to this Section 5.01(c) such Lender shall designate a different lending office if such designation (x) will, in the reasonable judgment of such Lender, avoid the need for, or reduce the amount of, such compensation and (y) will not, in the reasonable judgment of such Lender, be materially disadvantageous to such Lender.  A certificate of such Lender claiming compensation under this Section 5.01, setting forth in reasonable detail the additional amount or amounts to be paid to it hereunder, shall be conclusive and binding on the Borrower in the absence of manifest error.

(d) Notwithstanding anything herein to the contrary, (x) the Dodd-Frank Wall Street Reform and Consumer Protection Act and all requests, rules, guidelines or directives thereunder or issued in connection therewith and (y) all requests, rules, guidelines or directives promulgated by the Bank for International Settlements, the Basel Committee on Banking Supervision (or any successor or similar authority) or the United States or foreign regulatory authorities, in each case pursuant to Basel III, shall in each case be deemed to constitute a change in Law for all purposes of this Section 5.01, regardless of the date enacted, adopted or issued.

Section 5.02. Illegality

.  Notwithstanding any other provision of this Agreement, in the event that on or after the date hereof the adoption of or any change in any applicable Law or in the interpretation or application thereof by any competent Governmental Authority shall make it unlawful for a Lender or its lending office to make or maintain the Loans by such Lender (and, in the opinion of such Lender, the designation of a different lending office would either not avoid such unlawfulness or would be disadvantageous to such Lender), then such Lender shall promptly notify the Borrower thereof, following which (i) such Lender’s Commitment shall be suspended until such time as such Lender may again make and maintain the Loans hereunder and (ii) if such Law shall so mandate, the Loans shall be prepaid by the Borrower on or before such date as shall be mandated by such Law in an amount equal to the aggregate principal amount of

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the Loans outstanding on the date of such prepayment plus any accrued but unpaid interest thereon.

Section 5.03. Taxes

.  For purposes of this Section 5.03, the term “applicable Law” includes FATCA.

(a) Payments Free of Taxes .  Any and all payments by or on account of any Obligation shall be made without deduction or withholding for any Taxes, except as required by any applicable Law.  If any applicable Law (as determined in the good faith discretion of an applicable Withholding Agent) requires the deduction or withholding of any Tax from any such payment by a Withholding Agent, then the applicable Withholding Agent shall be entitled to make such deduction or withholding and shall timely pay the full amount deducted or withheld to the relevant Governmental Authority in accordance with applicable Law and, if such Tax is an Indemnified Tax, then the sum payable by such Obligor shall be increased as necessary so that after such deduction or withholding has been made (including such deductions and withholdings applicable to additional sums payable under this Section 5.03) the applicable Recipient receives an amount equal to the sum it would have received had no such deduction or withholding been made.

(b) Payment of Other Taxes by the Borrower .  The Borrower shall timely pay to the relevant Governmental Authority in accordance with applicable Law, or at the option of the Administrative Agent, timely reimburse it for the payment of, Other Taxes.

(c) Evidence of Payments .  As soon as reasonably practicable after any payment of Taxes by the Borrower to a Governmental Authority pursuant to this Section 5.03, the Borrower shall deliver to the Administrative Agent the original or a certified copy of a receipt issued by such Governmental Authority evidencing such payment, a copy of the return reporting such payment or other evidence of such payment reasonably satisfactory to the Administrative Agent.

(d) Indemnification by the Borrower .  The Borrower shall reimburse and indemnify each Recipient, within ten (10) days after demand therefor, for the full amount of any Indemnified Taxes (including Indemnified Taxes imposed or asserted on or attributable to amounts payable under this Section 5.03) payable or paid by such Recipient or required to be withheld or deducted from a payment to such Recipient and any reasonable expenses arising therefrom or with respect thereto, whether or not such Indemnified Taxes were correctly or legally imposed or asserted by the relevant Governmental Authority.  A certificate as to the amount of such payment or liability delivered to the Borrower by a Lender (with a copy to the Administrative Agent), or by the Administrative Agent on its own behalf or on behalf of a Lender, shall be conclusive absent manifest error.

(e) Indemnification by the Lender .  Each Lender shall severally indemnify the Administrative Agent, within 10 days after demand therefor, for (i) any Indemnified Taxes attributable to such Lender (but only to the extent that the Borrower has not already indemnified the Administrative Agent for such Indemnified Taxes and without limiting the obligation of the Borrower to do so), and (ii) any Taxes attributable to such Lender, in each case, that are payable or paid by the Administrative Agent in connection with any Loan Document, and any reasonable expenses arising therefrom or with respect thereto, whether or not such Taxes were correctly or

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legally imposed or asserted by the relevant Governmental Authority.  A certi ficate as to the amount of such payment or liability delivered to any Lender by the Administrative Agent shall be conclusive absent manifest error.  Each Lender hereby authorizes the Administrative Agent to set off and apply any and all amounts at any time owing to such Lender under any Loan Document or otherwise payable by the Administrative Agent to such Lender from any other source against any amount due to the Administrative Agent under this paragraph (e).

(f) Status of Lenders .  (i) Any Lender that is entitled to an exemption from or reduction of withholding Tax with respect to payments made under any Loan Document shall deliver to the Borrower and the Administrative Agent, at the time or times prescribed by applicable Law or reasonably requested by the Borrower or the Administrative Agent, such properly completed and executed documentation reasonably requested by the Borrower or the Administrative Agent as will permit such payments to be made without withholding or at a reduced rate of withholding.  In addition, any Lender shall deliver such other documentation prescribed by Law or reasonably requested by the Borrower or the Administrative Agent as will enable the Borrower or the Administrative Agent to determine whether or not such Lender is subject to backup withholding or information reporting requirements.  Notwithstanding anything to the contrary in the preceding two sentences, the completion, execution and submission of such documentation (other than such documentation set forth in Section 5.03(f)(ii)(A), (ii)(B), and (ii)(D)) shall not be required if in such Lender’s reasonable judgment such completion, execution or submission would subject such Lender to any material unreimbursed cost or expense or would materially prejudice the legal or commercial position of such Lender.

(ii) Without limiting the generality of the foregoing:

(A) any Lender (or, if the Lender is a disregarded entity for U.S. federal income tax purposes, the Person treated as the owner of the assets of such Lender for U.S. federal income Tax purposes) that is a U.S. Person shall deliver to the Borrower and the Administrative Agent on or prior to the date on which such Lender becomes a Lender under this Agreement (and from time to time thereafter upon the reasonable request of the Borrower or the Administrative Agent), executed copies of IRS Form W-9 (or successor form) certifying that such Lender is exempt from U.S. federal backup withholding Tax;

(B) any Foreign Lender shall, to the extent it is legally entitled to do so, deliver to the Borrower and the Administrative Agent (in such number of copies as shall be requested by the recipient) on or prior to the date on which such Foreign Lender becomes a Lender under this Agreement (and from time to time thereafter upon the reasonable request of the Borrower and the Administrative Agent), whichever of the following is applicable:

(1) in the case of a Foreign Lender claiming the benefits of an income tax treaty to which the United States is a party (x) with respect to payments of interest under any Loan Document, executed copies of IRS Form W-8BEN or IRS Form W-8BEN-E as applicable (or successor forms) establishing an exemption from, or reduction of, U.S. federal withholding Tax pursuant to the “interest” article of such tax treaty and (y) with respect to any other applicable payments under any Loan Document, IRS Form W-8BEN or IRS Form W-8BEN-E as

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applicable (or successor forms) establishing an exemption from, or reduction of, U.S. federal withholding Tax pursuant to the “business profits” or “other income” article of such tax treaty;

(2) executed copies of IRS Form W-8ECI (or successor form);

(3) in the case of a Foreign Lender claiming the benefits of the exemption for portfolio interest under Section 881(c) of the Code, (x) a certificate substantially in the form of Exhibit D-1 to the effect that such Foreign Lender is not a “bank” within the meaning of Section 881(c)(3)(A) of the Code, a “10 percent shareholder” of the applicable the Borrower within the meaning of Section 881(c)(3)(B) of the Code, or a “controlled foreign corporation” described in Section 881(c)(3)(C) of the Code (a “ U.S. Tax Compliance Certificate ”) and (b) executed copies of IRS Form W-8BEN or IRS Form W-8BEN-E as applicable (or successor forms); or

(4) to the extent a Foreign Lender is not the beneficial owner, executed copies of IRS Form W-8IMY (or successor form), accompanied by IRS Form W-8ECI (or successor form), IRS Form W-8BEN (or successor form), IRS Form W-8BEN-E, a U.S. Tax Compliance Certificate, substantially in the form of Exhibit D-2 or D-3, IRS Form W-9 (or successor form), and/or other certification documents from each beneficial owner, as applicable; provided that if the Foreign Lender is a partnership and one (1) or more direct or indirect partners of such Foreign Lender are claiming the portfolio interest exemption, such Foreign Lender may provide a U.S. Tax Compliance Certificate substantially in the form of Exhibit D-4 on behalf of each such direct and indirect partner.

(C) any Foreign Lender shall, to the extent it is legally entitled to do so, deliver to the Borrower and the Administrative Agent (in such number of copies as shall be requested by the recipient) on or prior to the date on which such Foreign Lender becomes a Lender under this Agreement (and from time to time thereafter at the time or times prescribed by applicable Law or upon the reasonable request of the Borrower or the Administrative Agent), executed copies of any other form prescribed by applicable Law as a basis for claiming exemption from or a reduction in U.S. federal withholding Tax, duly completed, together with such supplementary documentation as may be prescribed by applicable Law to permit the Borrower or the Administrative Agent to determine the withholding or deduction required to be made; and

(D) if a payment made to a Lender under any Loan Document would be subject to U.S. federal withholding Tax imposed by FATCA if such Lender were to fail to comply with the applicable reporting requirements of FATCA (including those contained in Section 1471(b) or 1472(b) of the Code, as applicable), such Lender shall deliver to the Borrower and the Administrative Agent at the time or times prescribed by Law and at such time or times as reasonably requested by the Borrower or the Administrative Agent such documentation prescribed by applicable Law (including as prescribed by Section 1471(b)(3)(C)(i) of the Code) and such additional documentation reasonably requested by the Borrower or the Administrative Agent as may be necessary

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for t he Borrower and the Administrative Agent to comply with their obligations under FATCA and to determine that such Lender has complied with such Lender’s obligations under FATCA or to determine the amount to deduct and withhold from such payment.  Solely for purposes of this clause (D), “FATCA” shall include any amendments made to FATCA after the date of this Agreement.

Each Lender agrees that if any form or certification it previously delivered expires or becomes obsolete or inaccurate in any respect, it shall update such form or certification or promptly notify the Borrower and the Administrative Agent in writing of its legal inability to do so.

(g) Treatment of Certain Tax Benefits .  If any party to this Agreement determines, in its sole discretion exercised in good faith, that it has received a refund of any Taxes as to which it has been indemnified pursuant to this Section 5.03 (including by the payment of additional amounts pursuant to this Section 5.03), it shall pay to the indemnifying party an amount equal to such refund (but only to the extent of indemnity payments made under this Section 5.03 with respect to the Taxes giving rise to such refund), net of all out-of-pocket expenses (including Taxes) of such indemnified party and without interest (other than any interest paid by the relevant Governmental Authority with respect to such refund).  Such indemnifying party, upon the request of such indemnified party, shall repay to such indemnified party the amount paid over pursuant to this paragraph (plus any penalties, interest or other charges imposed by the relevant Governmental Authority) in the event that such indemnified party is required to repay such refund to such Governmental Authority.  Notwithstanding anything to the contrary in this Section 5.03(g), in no event will the indemnified party be required to pay any amount to an indemnifying party pursuant to this Section 5.03(g) the payment of which would place the indemnified party in a less favorable net after-Tax position than the indemnified party would have been in if the Tax subject to indemnification and giving rise to such refund had not been deducted, withheld or otherwise imposed and the indemnification payments or additional amounts with respect to such Tax had never been paid.  This Section 5.03(g) shall not be construed to require any indemnified party to make available its Tax returns (or any other information relating to its Taxes that it deems confidential) to the indemnifying party or any other Person.

(h) Designation of a Different Lending Office .  If the Borrower is required to pay any Indemnified Taxes or additional amounts to any Lender or to any Governmental Authority for the account of any Lender pursuant to Section 5.01 or this Section 5.03, then such Lender shall (at the request of the Borrower) use commercially reasonable efforts to designate a different lending office for funding or booking its Loans hereunder or to assign and delegate its rights and obligations hereunder to another of its offices, branches or Affiliates if, in the sole reasonable judgment of such Lender, such designation or assignment and delegation would (i) eliminate or reduce amounts payable pursuant to Section 5.01 or this Section 5.03, as the case may be, in the future, (ii) not subject such Lender to any unreimbursed cost or expense and (iii) not otherwise be disadvantageous to such Lender.  The Borrower hereby agrees to pay all reasonable costs and expenses incurred by any Lender in connection with any such designation or assignment and delegation.

(i) Survival .  Each party’s obligations under this Section 5 shall survive the resignation or replacement of the Administrative Agent or any assignment of rights by, or the

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replacement of, a Lender, the termination of the Commitments and the repayment, satisfaction or dischar ge of all Obligations under any Loan Document.

Section 5.04. Delay in Requests

.  Failure or delay on the part of any Lender to demand compensation pursuant to this Section 5 shall not constitute a waiver of such Lender’s right to demand such compensation; provided that the Borrower shall not be required to compensate a Lender pursuant to this Section for any increased costs incurred or reductions suffered more than six-months prior to the date that such Lender notifies the Borrower of the change in Law giving rise to such increased costs or reductions, and of such Lender’s intention to claim compensation therefor (except that, if the change in Law giving rise to such increased costs or reductions is retroactive, then the sixth-month period referred to above shall be extended to include the period of retroactive effect thereof).

SECTION 6.

Conditions Precedent.

Section 6.01. Conditions to the Closing Date

.  The obligation of each Lender to enter into this Agreement shall be subject to the execution and delivery of this Agreement by the parties hereto and the prior or concurrent satisfaction (or waiver thereof by the Administrative Agent) of each of the conditions precedent set forth below in this Section 6.01.

(a) Secretary’s Certificate, Etc .  The Administrative Agent shall have received from each Obligor (i) a copy of a good standing certificate, dated a date reasonably close to the Closing Date, for each such Person and (ii) a certificate, dated as of the Closing Date, duly executed and delivered by such Person’s Secretary or Assistant Secretary, managing member, general partner or equivalent, as to:

(i) resolutions of each such Person’s Board then in full force and effect authorizing the execution, delivery and performance of each Loan Document to be executed by such Person and the Transactions;

(ii) the incumbency and signatures of those of its officers, managing member, general partner or equivalent authorized to act with respect to each Loan Document to be executed by such Person; and

(iii) the full force and validity of each Organic Document of such Person and copies thereof.

(b) Closing Date Certificate .  The Administrative Agent shall have received a certificate, dated as of the Closing Date and duly executed and delivered by a Responsible Officer of the Borrower, which certificate shall be in the form attached hereto as Exhibit N, stating that (i) both immediately before and after giving effect to the Borrowing of the Tranche A Term Loans, (x) the representations and warranties set forth in each Loan Document shall, in each case, be true and correct in all material respects (or, in the case of any such representation or warranty already qualified by materiality, in all respects) and no Default shall have then occurred and be continuing, or would result from the making of the Loans being advanced on the Tranche A Term Loan Borrowing Date and (ii) all of the conditions set forth in Section 6.01 have been satisfied or waived by the Administrative Agent.

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(c) Solvency, Etc .  The Administrative Agent shall have received a solvency certificate duly executed and delivered by th e chief financial or accounting Responsible Officer of the Borrower, dated as of the Closing Date, in form and substance reasonably satisfactory to the Administrative Agent.

(d) Financial Information, Etc .  The Administrative Agent shall have received:

(i) audited consolidated financial statements of the Borrower and its Subsidiaries for the fiscal year ended December 31, 2016; provided that the Borrower’s filing of an Annual Report on Form 10-K with the SEC with respect thereto shall be deemed to satisfy the requirements of this Section; and

(ii) unaudited consolidated balance sheets of the Borrower and its Subsidiaries for each fiscal quarter ended after December 31, 2016, other than fiscal quarter ended December 31, 2017, together with the related consolidated statement of operations for such fiscal quarter; provided that the Borrower’s filing of a Quarterly Report on Form 10-Q with the SEC with respect to each such quarter shall be deemed to satisfy the requirements of this Section.

(e) Compliance Certificate .  The Administrative Agent shall have received an initial Compliance Certificate, prepared on a pro forma basis as of the Closing Date demonstrating compliance with the covenants set forth in Section 10, duly executed (and with all schedules thereto duly completed) and delivered by a Responsible Officer of the Borrower.

(f) Opinions of Counsel .  The Administrative Agent shall have received one (1) or more opinions, dated the Closing Date and addressed to the Administrative Agent and the Lenders, from Paul Hastings LLP, independent legal counsel to the Borrower and the other Obligors, in form and substance reasonably acceptable to the Administrative Agent.

(g) Delivery of Notes .  Each Lender that has requested a Note shall have received a Note for its Loan, duly executed and delivered by a Responsible Officer of the Borrower.

(h) Security Documents .  The Administrative Agent shall have received executed counterparts of each Security Document, dated as of Closing Date, duly executed and delivered by each Obligor, together with:

(i) delivery of all certificates (in the case of Equity Interests that are securities (as defined in the NY UCC)) evidencing the issued and outstanding capital Securities owned by each Obligor that are required to be pledged under the Security Agreement, which certificates in each case shall be accompanied by undated instruments of transfer duly executed in blank or, in the case of Equity Interests that are uncertificated securities (as defined in the NY UCC), confirmation and evidence reasonably satisfactory to the Administrative Agent that the security interest required to be pledged therein under the Security

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Agreement has been transferred to and perfected by the Administrative Agent in accordance with Articles 8 and 9 of the NY UCC and all laws otherwise ap plicable to the perfection of the pledge of such Equity Interests;

(ii) financing statements naming each Obligor as a debtor and the Administrative Agent as the secured party (for the benefit of all Secured Parties) or other similar instruments or documents, in each case suitable for filing, to be filed under the Uniform Commercial Code (or equivalent law) of all jurisdictions as may be necessary to perfect the Liens of the Administrative Agent, for the benefit of the Lenders, pursuant to the Security Agreement;

(iii) UCC-1 (or equivalent) Lien searches reasonably satisfactory in scope and substance to the Administrative Agent covering each Obligor and its properties;

(iv) UCC-3 termination statements, or equivalent, as may be necessary to release all Liens and other rights of any Person in any collateral described in the Security Agreement previously granted by any Person;

(v) evidence that all Deposit Accounts, Securities Accounts and Commodity Accounts (other than Excluded Accounts) of each Obligor are Controlled Accounts; and

(vi) all Short-Form IP Security Agreements required to be provided under the Security Agreement, each dated as of the Closing Date, duly executed and delivered by each Obligor that is required to do so under the Security Agreement.

(i) Material Adverse Change .  No Material Adverse Change shall have occurred since December 31, 2017.

(j) Fees and Expenses, Etc .  Each of the Administrative Agent and each Lender shall have received, for its own account, the fees, costs and expenses due and payable to it on the Closing Date pursuant to Sections 3.06 and 14.03, including all reasonable closing costs and fees and all unpaid reasonable expenses of the Administrative Agent and the Lenders incurred in connection with the Transactions (including the Administrative Agent’s and the Lenders’ reasonable and documented legal fees and expenses).

(k) Perfection Certificate .  The Administrative Agent shall have received a fully completed Perfection Certificate, dated as of the Closing Date, duly executed and delivered by a Responsible Officer of the Borrower.

(l) Warrant .  The Administrative Agent shall have received the executed Tranche A Warrant, dated as of the Closing Date.

(m) Insurance .  The Administrative Agent shall have received certificates and endorsements of insurance evidencing the existence of all insurance required to be

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maintained by the Obligors and their respective Subsidiaries pursuant to Section 8.05 and the designation of the Administrative Agent as the Borrower’s loss payee or additional insured, as applicable.

(n) Pay-Off Letters .  The Administrative Agent shall have received executed Pay-Off Letters terminating and cancelling the Pay-Off Indebtedness in full, in form and substance reasonably acceptable to it.

Section 6.02. Conditions to the Tranche B Term Loan; Tranche B Term Loan Borrowing Date

.  The obligation of each Lender to make the Tranche B Term Loan on the Tranche B Term Loan Borrowing Date shall be subject to the delivery of a Borrowing Notice as required pursuant to Section 2.01(b) and the prior or concurrent satisfaction (or waiver thereof by the Administrative Agent) of each of the conditions precedent set forth below in this Section 6.02.

(a) Tranche B Term Loan Borrowing Date Certificate .  The Administrative Agent shall have received a certificate, dated as of the proposed Tranche B Term Loan Borrowing Date and duly executed and delivered by a Responsible Officer of the Borrower, which certificate shall be in the form attached hereto as Exhibit O, stating that (i) both immediately before and after giving effect to the Borrowing, (x) the representations and warranties set forth in each Loan Document shall, in each case, be true and correct in all material respects (or, in the case of any such representation or warranty already qualified by materiality, in all respects) and (y) no Default shall have then occurred and be continuing, or would result from the making of the Loans being advanced on the proposed Tranche B Term Loan Borrowing Date and (ii) all of the conditions set forth in Section 6.02 and 8.01(k) have been satisfied or waived by the Administrative Agent.

(b) Minimum Product Revenue .  The consolidated Product Revenue of the Borrower and its Subsidiaries for the period of four (4) consecutive fiscal quarters ended on the last day of the fiscal quarter before the proposed Tranche B Term Loan Borrowing Date shall be not less than $47,000,000.

(c) Warrant .  The Administrative Agent shall have received the executed Tranche B Warrant, dated as of the Tranche B Term Loan Borrowing Date.

SECTION 7.

Representations and Warranties.

On the Closing Date and each Borrowing Date, the Borrower and each other Obligor hereby jointly and severally represents and warrants to the Administrative Agent and each Lender that:

Section 7.01. Power and Authority

.  Each Obligor (i) is duly organized and validly existing under the laws of its jurisdiction of organization, (ii) has all requisite corporate or other organizational power, and has all Governmental Approvals necessary to own its assets and carry on its business as now being, or as proposed to be conducted, except to the extent that failure to have the same would not reasonably be expected to have a Material Adverse Effect, (iii) is qualified to do business and is in good standing in all jurisdictions in which the nature of the

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business conducted by it makes such qualification nec essary and where failure so to qualify (either individually or in the aggregate) would reasonably be expected to have a Material Adverse Effect, and (iv) has full power, authority and legal right to enter into and perform its obligations under each of the Loan Documents to which it is a party and, in the case of the Borrower, to borrow the Loans hereunder.

Section 7.02. Authorization; Enforceability

.  The Transactions are within each Obligor’s corporate or other organizational powers and have been duly authorized by all necessary corporate or other organizational action and, if required, by all necessary equity holder action on the part of such Obligor.  This Agreement has been duly executed and delivered by each Obligor and constitutes, and each of the other Loan Documents to which it is a party when executed and delivered by such Obligor will constitute, a legal, valid and binding obligation of such Obligor, enforceable against such Obligor in accordance with its terms, except as such enforceability may be limited by (i) bankruptcy, insolvency, reorganization, moratorium or similar laws of general applicability affecting the enforcement of creditors’ rights and (ii) the application of general principles of equity (regardless of whether such enforceability is considered in a proceeding in equity or at law).

Section 7.03. Governmental and Other Approvals; No Conflicts

.  None of the Transactions (i) requires any Governmental Approval of, registration or filing with, or any other action by, any Governmental Authority or any other Person, except for (x) such as have been obtained or made and are in full force and effect and (y) filings and recordings in respect of perfecting or recording the Liens created pursuant to the Security Documents, (ii) will violate any applicable Law or any Organic Document of any Obligor or any of its Subsidiaries or any order of any Governmental Authority, other than any such violations that, individually or in the aggregate, would not reasonably be expected to have a Material Adverse Effect, (iii) will result in a default under (x) any Material Agreement or (y) any Contract creating or evidencing any Material Indebtedness or (iv) will result in the creation or imposition of any Lien (other than Permitted Liens) on any asset of any Obligor or any of its Subsidiaries.

Section 7.04. Financial Statements; Material Adverse Change.

(a) Financial Statements .  The Borrower has heretofore furnished to the Administrative Agent and the Lenders certain consolidated financial statements as provided for in Section 6.01(d).  Such financial statements, and all other financial statements delivered by the Borrower pursuant hereto (whether prior to the Closing Date or otherwise), present fairly, in all material respects, the consolidated financial position and results of operations and cash flows of the Borrower and its Subsidiaries as of such dates and for such periods in accordance with GAAP, subject to year-end audit adjustments and the absence of footnotes in the case of the statements of the type described in Section 8.01(a).  Neither the Borrower nor any of its Subsidiaries has any material (i) contingent liabilities or (ii) unusual forward or long-term commitments not disclosed in the aforementioned financial statements.

(b) No Material Adverse Change .  Since December 31, 2017, there has been no Material Adverse Change.

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Section 7.05. Properties.

(a) Property Generally .  Each Obligor has good title to, or valid leasehold interests in, all its real and tangible personal property material to its business subject only to Permitted Liens and except as would not reasonably be expected to materially interfere with its ability to conduct its business as currently conducted or to utilize any material properties for their intended purposes.

(b) Intellectual Property .  (i) Schedule 7.05(b)(i) contains with respect to each Obligor and each of its Subsidiaries (set for forth on an entity by entity basis):

(A) a complete and accurate list of all applied for, issued, or registered active Patents owned by or licensed to an Obligor or one of its Subsidiaries, including, with respect to Patents owned by an Obligor or one of its Subsidiaries, the jurisdiction and patent number;

(B) a complete and accurate list of all material applied for, or registered active Trademarks owned by or licensed to an Obligor or one of its Subsidiaries, including, with respect to Trademarks owned by an Obligor or one of its Subsidiaries, the jurisdiction, trademark application or registration number and the application or registration date; and

(C) a complete and accurate list of all material applied for or registered Copyrights owned by or licensed to an Obligor or one of its Subsidiaries.

(ii) Each Obligor is the beneficial owner of all right, title and interest in and to the Obligor Intellectual Property (including, without limitation, Obligor Intellectual Property indicated on Schedule 7.05(b) as being owned by such Obligor), free and clear of any Liens or Claims of any kind whatsoever other than Permitted Liens.  Without limiting the foregoing, and except as set forth in Schedule 7.05(b)(ii):

(A) other than as permitted by Section 9.09, no Obligor, nor any of its Subsidiaries, has transferred ownership of any of its Material Intellectual Property, in whole or in part, to any Person who is not an Obligor;

(B) to the Borrower’s knowledge, the use by such Obligor or any of its Subsidiaries of any of their respective Obligor Intellectual Property in the ordinary course of such Person’s businesses does not breach, violate, infringe or interfere with or constitute a misappropriation of any valid rights arising under any Intellectual Property of any other Person;

(C) (1) there are no Claims pending or, to the Borrower’s knowledge, threatened in writing against any Obligor or any of its Subsidiaries asserted by any other Person relating to any Obligor Intellectual Property, including any Claims of adverse ownership, invalidity, infringement, misappropriation, violation or other opposition to or conflict with such Obligor Intellectual Property; and (2) no Obligor has in the past twelve (12) months received any written notice with respect to the use of any Obligor Intellectual Property from any Person;

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(D) the Borrower has no knowledge that any Obligor Intellectual Property is being materially infringed, violated, misappropriated or otherwise used by any other Person without the express authorizati on of the Borrower; and, without limiting the foregoing, no Obligor has in the past twelve (12) months put any other Person on notice of any actual or potential material infringement, violation or misappropriation of any Obligor Intellectual Property, and no Obligor has in the past twelve (12) months initiated the enforcement of any Claim with respect to any Obligor Intellectual Property for any such material infringement, violation or misappropriation;

(E) to the Borrower’s knowledge, each Obligor has taken reasonable precautions to protect the secrecy, confidentiality and value of its Obligor Intellectual Property consisting of trade secrets and confidential information; and

(F) there are no Claims pending or, to the Borrower’s knowledge, threatened in writing against the Obligors or any of their Subsidiaries asserted by any other Person relating to the Material Agreements with respect to Obligor Intellectual Property, including any Claims of breach or default under such Material Agreements.

(iii) With respect to the Material Intellectual Property consisting of Patents owned by Borrower or any of its Subsidiaries, except as set forth in Schedule 7.05(b)(ii), and without limiting the representations and warranties in Section 7.05(b)(ii), to the Borrower’s knowledge:

(A) all such Patents are, to the extent issued, valid, subsisting, and enforceable;

(B) none of the Patents, or the Inventions claimed in any such Patent, have been dedicated to the public except as a result of intentional decisions made by the applicable Obligor;

(C) no such Patents have ever been finally adjudicated to be invalid, unpatentable or unenforceable for any reason in any administrative, arbitration, judicial or other proceeding, and, with the exception of publicly available documents in the applicable patent office recorded with respect to any Patents, no Obligor has received any notice asserting that such Patents are invalid, unpatentable or unenforceable; if any of such Patents is terminally disclaimed to another patent or patent application, all patents and patent applications subject to such terminal disclaimer are included in the Collateral;

(D) no Obligor, nor any prior owner of any Patent, or any of their respective agents or representatives, have engaged in any conduct, or omitted to perform any necessary act, the result of which would invalidate or render unpatentable or unenforceable any Patent; and

(E) all maintenance fees, annuities, and the like due or payable on or with respect to any Patents have been timely paid or the failure to so pay would not reasonably be expected to result in a Material Adverse Effect.

(c) Material Intellectual Property .  Schedule 7.05(c) contains an accurate list of the Obligor Intellectual Property that is a Patent, registered or applied for Trademark, or registered

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Copyright and that is material to the sale Products or Product Commercialization and Development Activities.

Section 7.06. No Actions or Proceedings.

(a) Litigation .  There is no litigation, investigation or proceeding pending or, to the Borrower’s knowledge, threatened in writing with respect to any Obligor or any of its Subsidiaries by or before any Governmental Authority or arbitrator that (i) either individually or in the aggregate would reasonably be expected to have a Material Adverse Effect, except as specified in Schedule 7.06(a), or (ii) involves this Agreement, any other Loan Document or the Transactions.

(b) Environmental Matters .  The operations and property of such Obligor and each of its Subsidiaries comply with all applicable Environmental Laws, except to the extent the failure to so comply (either individually or in the aggregate) would not reasonably be expected to have a Material Adverse Effect.

(c) Labor Matters .  There are no labor disputes against the Borrower or any Subsidiary or, to the Borrower’s knowledge, threatened in writing against the Borrower or any Subsidiary, and no unfair labor practice complaint is pending against the Borrower or any Subsidiary or, to the knowledge of the Borrower, threatened in writing against any of them before any Governmental Authority, in each case which would reasonably be expected to result in a Material Adverse Effect.  There is no material strike or work stoppage in existence or threatened in writing against the Borrower or any Subsidiary.  Except as set forth on Schedule 7.06(c), the Borrower is not party to any collective bargaining agreements or contracts, no union representation exists at any facilities of the Borrower or any of its Subsidiaries and, to the knowledge of the Borrower, no union organizing activities with respect to its business are taking place.

Section 7.07. Compliance with Laws and Agreements

.  (a) Each of the Obligors is in compliance with all Laws applicable to it and all Contracts binding upon it or its property, including all applicable Healthcare Laws and Environmental Laws, except where the failure to be so, individually or in the aggregate, would not reasonably be expected to result in a Material Adverse Effect.

(b) Health Care Matters .  Without limiting the generality of the foregoing:

(i) Any physician, other licensed healthcare professional, or any other Person who is in a position to refer patients or other business to the Borrower, any other Obligor or any Subsidiaries (collectively, a “ Referral Source ”) who has a direct ownership, investment or financial interest in the Borrower, any other Obligor or any such Subsidiary, to the Borrower’s knowledge, paid fair market value for such ownership, investment or financial interest; any ownership or investment returns distributed to any Referral Source is in proportion to such Referral Source’s ownership, investment or financial interest; and no preferential treatment or more favorable terms were or are offered to such Referral Source than compared to investors or owners who are not in a position to refer patients or other business. Neither the Borrower, any other Obligor, nor any of their respective Subsidiaries, directly or indirectly, have or will

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guarantee a loan, make a payment toward a loan or otherwise subsidize a loan for any Referral Source including, without limitation, any loans related to financing the Referral Source’s ownership, investment or financial interest in the Borrower, any other Obligor or any such Subsidiary.

(ii) Except where noncompliance individually or in the aggregate would not reasonably be expected to result in a Material Adverse Effect, any financial relationships between or among the Borrower, any other Obligor, or any of their respective Subsidiaries, on the one hand, and any Referral Source, on the other hand (A) comply with all applicable Healthcare Laws including, without limitation, the Federal Anti-Kickback Statute, the Stark Law and applicable state anti-kickback and self-referral laws; (B) reflect fair market value, have commercially reasonable terms, and were negotiated at arm’s length; and (C) do not obligate the Referral Source to purchase, use, recommend or arrange for the use of any products or services of the Borrower, any other Obligor, or any of their respective Subsidiaries.

(iii) All Products have been developed, tested, manufactured, distributed, marketed and sold in compliance in all material respects with all applicable FDA Laws.

(iv) Each Obligor and each Subsidiary has the requisite provider number or authorization necessary to bill any third-party payor program (including any Federal Health Care Program) in which it participates.  There are no current or pending audits, inquiries, adjustments, appeals or recoupment efforts by an third party payor programs of or against any Obligor or Subsidiary with respect to any prior claims, reports or billings that, individually or in the aggregate, would reasonably be expected to result in a Material Adverse Effect.

(v) No Obligor or Subsidiary (i) has knowingly retained a material overpayment received from, or failed to refund any material amount due to, any third party payor program in material violation of any applicable Health Care Law; or (ii) has received written notice of any material overpayment or refunds due to any third party payor program in material violation of any applicable Healthcare Law.

(vi) No Obligor or Subsidiary, or to the knowledge of the Borrower, any officer, affiliate, employee or agent of an Obligor or Subsidiary, has made an untrue statement of a material fact or fraudulent statement to any Governmental Authority, failed to disclose a material fact that must be disclosed to any Governmental Authority, or committed an act, made a statement or failed to make a statement that, at the time such statement, disclosure or failure to disclose occurred, that individually or in the aggregate, would reasonably be expected to result in a Material Adverse Effect.

(vii) No Obligor or Subsidiary is a party to, or bound by, any individual integrity agreement, corporate integrity agreement, corporate compliance agreement or deferred prosecution agreement.

(viii) Except where any of the following would not be reasonably expected to result in a Material Adverse Effect, no Obligor nor any of its Subsidiaries, nor, to the knowledge of the Borrower, any owner, officer, director, managing employee or person with a “direct or indirect ownership interest” (as that phrase is defined in 42 C.F.R. § 420.201) in an Obligor or

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Subsidiary, is (i) excluded from any Federal Health Care Program, (ii) “suspended” or “debarred” from selling products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (42 C.F.R. Subpart 9.4), (iii) debarred, disqualified, suspended or excluded from participation in any third party payor progra m or is listed on the General Services Administration list of excluded parties, nor, to the knowledge of the Borrower, is any such debarment, disqualification, suspension or exclusion threatened or pending, or (iv) made a party to any other action by any G overnmental Authority that may prohibit it from selling products or providing services to any governmental or other purchaser pursuant to any federal, state or local laws or regulations.

(ix) Each Obligor and Subsidiary maintains and adheres to, in all material respects, a reasonable compliance program designed to promote compliance with and to detect, prevent and address violations of all material Healthcare Laws structured in light of the guidance promulgated by the Office of Inspector General of the U.S. Department of Health and Human Services setting forth the seven elements of an effective compliance program (a “ Health Care Compliance Program ”).  The Borrower has no knowledge of any complaints from any employees, independent contractors, vendors, physicians, customers, patients or other persons that would reasonably be considered to indicate a violation of Healthcare Laws which would be reasonably expected to result individually or in the aggregate in a Material Adverse Effect.

Section 7.08. Taxes

.  Each of the Obligors has timely filed or caused to be filed all income and other material tax returns and reports required to have been filed and has paid or caused to be paid all material Taxes, fees, assessments and governmental charges or levies required to have been paid by it, except Taxes, fees, assessments and governmental charges or levies that are being contested in good faith by appropriate proceedings and for which such Obligor has set aside on its books adequate reserves with respect thereto in accordance with GAAP.

Section 7.09. Full Disclosure

.  None of the reports, financial statements, certificates or other information furnished by or on behalf of the Obligors to any Lender in connection with the negotiation of this Agreement and the other Loan Documents or delivered hereunder or thereunder (as modified or supplemented by other information so furnished) contains any misstatement of material fact or omits to state any material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided that, with respect to projected financial information, the Borrower represents only that such information was prepared in good faith based upon assumptions believed to be reasonable at the time (it being understood by the Administrative Agent and the Lenders that such projected financial information is not to be viewed as fact, and that no assurances can be given that any particular projections will be realized and that actual results during the period or periods covered by any such projections may differ from the projected results and such differences may be material).

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Section 7.10. Investment Company and Margin Stock Regulation.

(a) Investment Company Act .  Neither the Borrower nor any of its Subsidiaries is an “investment company” as defined in, or subject to regulation under, the Investment Company Act of 1940.

(b) Margin Stock .  Neither the Borrower nor any of its Subsidiaries is engaged principally, or as one of its important activities, in the business of extending credit for the purpose, whether immediate, incidental or ultimate, of buying or carrying Margin Stock, and no part of the proceeds of the Loans will be used to buy or carry any Margin Stock in violation of Regulation T, U or X.

Section 7.11. Solvency

.  The Borrower and its Subsidiaries, on a consolidated basis, are and, immediately after giving effect to each Borrowing and the use of proceeds thereof, will be Solvent.

Section 7.12. Equity Holders; Subsidiaries; Equity Investments

.  (a) The Borrower is not in material breach of any Material Agreement between the Borrower and any of the holders of Equity Interests of the Borrower, and the Borrower has fulfilled all of its material obligations under any such Material Agreements.  The Borrower has received all consents of the holders of the Equity Interests of the Borrower necessary for the Transactions, including any such consent pursuant to any right of first refusal, right of first offer, tag-along right, co-sale right or similar rights, and, as of the date hereof, all of the holders of Equity Interests of the Borrower with any such rights have declined to exercise such rights in connection with the Transactions.

(b) Set forth on Schedule 7.12(b) is a complete and correct list of all Subsidiaries of the Borrower.  Each such Subsidiary is duly organized and validly existing under the jurisdiction of its organization shown in said Schedule 7.12(b), and the percentage ownership by the Borrower or other entity of each such Subsidiary is as shown in said Schedule 7.12(b).

(c) Set forth on Schedule 7.12(c) is a complete and correct list of all other Equity Interests held by each Obligor in any Person that is not a direct or indirect Subsidiary of the Borrower.  Such Schedule 7.12(c) also sets forth in reasonable detail, the type of Equity Interest held by each such Obligor in such Person and the fully-diluted percentage ownership held beneficially by such Obligor in such Person.

Section 7.13. Indebtedness and Liens

.  Set forth on Schedule 7.13(a) is a complete and correct list of all Scheduled Indebtedness of the Borrower and each of its Subsidiaries outstanding as of the Closing Date.  Schedule 7.13(b) sets forth a complete and correct list of all Liens securing Scheduled Indebtedness with an aggregate principal amount in excess of $100,000, granted by the Borrower and other Obligors with respect to their respective property which are outstanding as of the Closing Date (other than the Liens granted pursuant to the Loan Documents).

Section 7.14. Material Agreements

.  Set forth on Schedule 7.14 is a complete and correct list of the Material Agreements.  No Obligor is in material default under any Material Agreement and the Borrower has no knowledge of any material default by any counterparty to any such Material Agreement or Contract. Except as otherwise disclosed on Schedule 7.14, all

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Material Agreements that include a grant of rights under any Material Intellectual Property to an Obligor are in full force and effect without material modification from the form in which the same were d isclosed to the Administrative Agent.

Section 7.15. Restrictive Agreements

.  Except as set forth in Schedule 7.15, no Obligor or any of its Subsidiaries is subject to any Restrictive Agreement, except those permitted under Section 9.11.

Section 7.16. Real Property

.  Except as set forth in Schedule 7.16, no Obligor or any of its Subsidiaries owns or leases (as tenant thereof) any real property.

Section 7.17. Pension Matters

.  Schedule 7.17 sets forth a complete and correct list of, and that separately identifies, (i) all Title IV Plans and (ii) all Multiemployer Plans.  Except for those that would not reasonably be expected to, in the aggregate, have a Material Adverse Effect or result under ERISA or Code Section 430(k) in a Lien under on the assets or property of any Obligor or any of its Subsidiaries, no ERISA Event has occurred in connection with which obligations and liabilities (contingent or otherwise) remain outstanding or is reasonably expected to occur.

Section 7.18. Collateral; Security Interest

.  Each Security Document is effective to create in favor of the Administrative Agent (for the benefit of the Secured Parties) a legal, valid and enforceable security interest, as security for the Obligations, in the Collateral subject to such Security Document and each such security interest is perfected on a first-priority basis (subject only to Permitted Priority Liens).

Section 7.19. Regulatory Approvals

.  (a) With respect to the Products, the Obligors hold, either directly or through licensees and agents, all material Regulatory Approvals necessary or required for such Obligor and each of its Subsidiaries to conduct all Product Commercialization and Development Activities with respect to the Products.

(b) Set forth on Schedule 7.19(b) is a complete and accurate list of all Regulatory Approvals referred to in clause (a) above, setting forth (in reasonable detail and on a Product-by- Product basis) the Obligor that holds such Regulatory Approval and briefly explaining the purpose of such Regulatory Approval.  All such Regulatory Approvals are:  (i) legally and beneficially owned or held exclusively by such Obligor identified on Schedule 7.19(b), free and clear of all Liens other than Permitted Liens, (ii) validly registered and on file with the applicable Regulatory Authority, in material compliance with all registration, filing and maintenance requirements (including any fee requirements) thereof, and (iii) valid, enforceable, in good standing and in full force and effect, with the applicable Regulatory Authority in all material respects.

(c) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Approval or Product Authorization with respect to any Product or any Product Commercialization and Development Activities have been made (including all required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, Product reports or other reports of adverse experiences) and all other required filings with respect to the Services or any related Product Commercialization and Development Activities),

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and all such filings are complete and correct and are in material compliance with all appl icable Laws.

(d) Each Obligor and each of its Subsidiaries, licensees and agents are in material compliance with all applicable Laws (including all Regulatory Approvals and Product Authorizations) with respect to all Product sold or provided by such Person, directly or indirectly, and all Product Commercialization and Development Activities conducted by such Person.

(e) Except as set forth on Schedule 7.19(e), and without limiting the generality of any other representation or warranty made by any Obligor hereunder or under any other Loan Document:  (i) the sale of all Products is in material compliance with (A) each applicable Regulatory Authority and (B) all Product Authorizations and other Regulatory Authorizations; (ii) no Obligor, nor any of their Subsidiaries nor, to the knowledge of the Borrower, any of their respective agents, suppliers, licensors or licensees have received any material warning letters or notices or similar documents with respect to any Product from any Regulatory Authority within the last three (3) years that asserts a material lack of compliance with any applicable Laws or Regulatory Approval or other order, injunction, or decree; (iii) no Obligor, nor any of their Subsidiaries nor, to the knowledge of the Borrower, any of their respective agents, suppliers, licensors or licensees have received any notification from any Regulatory Authority within the last three (3) years, asserting that any Product lacks a required Regulatory Approval or Product Authorization; (iv) the Borrower has no knowledge of any pending regulatory action, investigation or inquiry (other than non-material routine or periodic inspections or reviews) against any Obligor, any of its Subsidiaries or, to the knowledge of the Borrower, any of their respective suppliers, licensors or licensees with respect to any Product, and, to the knowledge of the Borrower, there is no basis for any adverse regulatory action against such Obligor or any of its Subsidiaries or, to the knowledge of the Borrower, any of their respective suppliers agents, licensors or licensees with respect to any Product; and (v) without limiting the foregoing, (A) (1) there have been no material safety alerts, corrections, marketing suspensions, removals or the like conducted, undertaken or issued by any Obligor or any of its Subsidiaries, whether voluntary or at the request, demand or order of any Regulatory Authority or otherwise, with respect to any Product within the last three (3) years, (2) no safety alert, correction, marketing suspension, removal or the like has been requested, demanded or ordered by any Regulatory Authority within the last three (3) years, and, to the knowledge of the Borrower, there is no basis for the issuance of any safety alert, correction, marketing suspension, removal or the like with respect to any Product, and (B) no criminal, injunctive, seizure, detention or civil penalty action has been commenced or, to the Borrower’s knowledge, threatened in writing by any Regulatory Authority within the last three (3) years with respect to or in connection with any Product, there are no consent decrees (including plea agreements) that relate to any Product, and, to the knowledge of the Borrower, there is no basis for the commencement of any criminal injunctive, seizure, detention or civil penalty action by any Regulatory Authority relating to any Product or for the issuance of any consent decree.  To the knowledge of the Borrower, no Obligor nor any of its Subsidiaries nor any of their respective agents, suppliers, licensees or licensors is employing or utilizing the services of any individual who has been debarred or temporarily suspended under any applicable Law.

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(f) No Obligor nor any of its Subsidiaries, nor, to the knowledge of the Borrower, any of their respective officers, employees or agents, h as made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a stat ement, or failed to make a statement that, at the time such disclosure was made (or was not made), would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Mat erial Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.

(g) The clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by each Obligor and each of its Subsidiaries, or in respect of which any Product candidates under development have participated, were (and if still pending, are) being conducted, to the Borrower’s knowledge, materially in accordance with standard medical and scientific research procedures and all applicable Product Authorizations.  No Obligor has received any notices or other correspondence from the FDA or any other Regulatory Authority requiring the termination or suspension of any clinical, preclinical, safety or other studies or tests used to support regulatory clearance of, or any Product Authorization or Regulatory Approval for, any Product.

(h) No material debarment or exclusionary claims, actions, proceedings or investigations in respect of any Obligor’s business is pending, or to the Borrower’s knowledge, threatened in writing against such Obligor or its officers, employees or agents.  No Obligor or, to the Borrower’s knowledge, any officer, employee or agent of such Obligor, has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in a debarment or exclusion (i) under Section 335a of the FD&C Act or (ii) any similar applicable Law.

Section 7.20. [Reserved].

Section 7.21. OFAC

.  Except as set forth on Schedule 7.21, no Obligor nor any of its Subsidiaries, nor, to the knowledge of the Borrower, any of their respective directors, officers, or employees nor, to the knowledge of the Borrower, any agents or other Persons acting on behalf of any of the foregoing (i) is currently the target of any Sanctions, (ii) is located, organized or residing in any Designated Jurisdiction, (iii) is or has been engaged in any transaction with, or for the benefit of, any Person who is now or was then the target of Sanctions or who is located, organized or residing in any Designated Jurisdiction or (iv) is or has ever been in violation in any material respect of or subject to an investigation relating to Sanctions.  No Loan, nor the proceeds from any Loan, has been or will be used, directly or indirectly, to lend, contribute or provide to, or has been or will be otherwise made available to fund, any activity or business in any Designated Jurisdiction or to fund any activity or business of any Person, to the Borrower’s knowledge, located, organized or residing in any Designated Jurisdiction or who is the subject of any Sanctions, or in any other manner that will result in any violation in any material respect by the Borrower or any of its Subsidiaries of Sanctions.

Section 7.22. Anti-Corruption

.  No Obligor nor any of its Subsidiaries, nor, to the knowledge of the Borrower, any of their respective directors, officers or employees nor, to the

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knowledge of the Borrower, any agents or other Persons acting on behalf of any of the foregoing, directly or indirectly, has (i) violated or is in violation, in any materi al respect, of any applicable anti-corruption Law, or (ii) made, offered to make, promised to make or authorized the payment or giving of, directly or indirectly, any Prohibited Payment.  To the Borrower’s knowledge, no Obligor has been subject to any inve stigation by any Governmental Authority with regard to any actual or alleged Prohibited Payment.

Section 7.23. Deposit and Disbursement Accounts

.  Schedule 7.23 contains a list of all banks and other financial institutions at which any Obligor or any of its Subsidiaries maintains Deposit Accounts, Securities Accounts and Commodity Accounts, and Schedule 7.23 sets forth the name, address and telephone number of each such bank or financial institution, the name in which such account is held, the type of such account and the complete account number therefor.

Section 7.24. Royalty and Other Payments

.  Except as set forth on Schedule 7.24, no Obligor, nor any of its Subsidiaries, is obligated to pay any royalty, milestone payment, deferred payment or any other contingent payment in respect of any Product or Product Commercialization and Development Activity.

SECTION 8.

Affirmative Covenants.

Each Obligor covenants and agrees with the Lenders that, until the Commitments have expired or been terminated and all Obligations (other than Warrant Obligations and contingent obligations as to which no claims have been asserted) have been indefeasibly paid in full in cash:

Section 8.01. Financial Statements and Other Information

.  The Borrower will furnish to the Administrative Agent:

(a) as soon as available and in any event within five (5) Business Days following the date on which the Borrower files or is required to file a Quarterly Report on Form 10-Q with the SEC, a consolidated balance sheet for the Borrower and its Subsidiaries as of the end of such quarter, and the related consolidated statements of income and cash flows for such quarter and the portion of the fiscal year through the end of such quarter, all in reasonable detail and setting forth in comparative form the figures for the corresponding period in the preceding fiscal year, together with a certificate of a Responsible Officer of the Borrower stating that such financial statements fairly present in all material respects the financial condition of the Borrower and its Subsidiaries as at such date and the results of operations of the Borrower and its Subsidiaries for the period ended on such date and have been prepared in accordance with GAAP, subject to changes resulting from normal, year-end audit adjustments and except for the absence of notes; provided that, so long as the Borrower is subject to the public reporting requirements of the Exchange Act, the Borrower’s filing of a Quarterly Report on Form 10-Q with the SEC shall be deemed to satisfy the requirements of this Section 8.01(a) on the date on which such report is first available via the SEC’s EDGAR system or a successor system related thereto;

(b) as soon as available and in any event within five (5) Business Days following the date on which the Borrower files or is required to file its Annual Report on

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Form 10-K with the SEC, a consolidated balance sheet for the Borrower and its Subsidiaries as of the end of such fiscal year, and the related consolidated statements of income, shareholders’ equity and cash flows for such fiscal year, all in reasonabl e detail and setting forth in comparative form the figures for the previous fiscal year, accompanied by a report and opinion thereon of Ernst & Young LLP or another firm of independent certified public accountants of recognized national standing reasonably acceptable to the Administrative Agent, which report and opinion shall be prepared in accordance with GAAP and shall not be subject to any Impermissible Qualification; provided that, so long as the Borrower is subject to the public reporting requirements of the Exchange Act, the Borrower’s filing of an Annual Report on Form 10-K with the SEC shall be deemed to satisfy the requirements of this Section 8.01(b) on the date on which such report is first available via the SEC’s EDGAR system or a successor syste m related thereto;

(c) within three (3) Business Days after the delivery of the financial statements required pursuant to Sections 8.01(a) and (b), a compliance certificate signed by a Responsible Officer of the Borrower as of the end of the applicable accounting period substantially in the form of Exhibit E (a “ Compliance Certificate ”), including details of any issues raised by the Borrower’s auditors that would be reasonably likely to result in a Material Adverse Effect and the creation or other acquisition of any Intellectual Property by any Obligor or any of its Subsidiaries after the date hereof and during such prior fiscal quarter for which such Compliance Certificate is delivered, which is registered or becomes registered or the subject of an application for registration with the U.S. Copyright Office or the U.S. Patent and Trademark Office, as applicable, or with any other equivalent foreign Governmental Authority;

(d) within three (3) Business Days after the end of each fiscal month, a certificate signed by a Responsible Officer of the Borrower as of the end of such fiscal month demonstrating compliance with Section 10.01 hereof;

(e) as soon as available and in any event no later than forty-five (45) days following the end of any fiscal year of the Borrower, copies of an annual budget (or equivalent) for the Borrower and its Subsidiaries, approved by the Borrower’s Board for the next succeeding fiscal year, in form reasonably satisfactory to the Administrative Agent, accompanied by a certificate of the chief financial officer of the Borrower certifying that (i) such budget was prepared by the Borrower in good faith, (ii) the Borrower had at the time of preparation of the budget, and at all times thereafter (including on and as of the date of delivery to the Administrative Agent of such budget) has continued to have, a reasonable basis for all of the assumptions contained in such budget and (iii) such budget was prepared in accordance with, and based upon, such assumptions;

(f) promptly, and in any event within five (5) Business Days after receipt thereof by any Obligor, copies of each notice or other correspondence received from the SEC (or comparable agency in any applicable non-U.S. jurisdiction) concerning any investigation or possible investigation or other inquiry by such agency regarding financial or other operational results of such Obligor (but in any case excluding any routine

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comments and letters from the SEC relating to such Obligor’s filings with the SEC or information that would violate confidentiality obliga tions to a Governmental Authority);

(g) information regarding insurance maintained by the Borrower and its Subsidiaries as required under Section 8.05;

(h) within five (5) days after delivery thereof to such holders, copies of all statements, reports and notices made available in general to all of the holders of the Borrower’s Equity Interests; provided that any such material may be redacted by the Borrower to (i) exclude information relating to the Lenders (including the Borrower’s strategy regarding the Loans), (ii) prevent the disclosure of trade secrets and (iii) protect and preserve attorney-client privilege; provided further that, so long as the Borrower is subject to the public reporting requirements of the Exchange Act, the Borrower’s filing of any of the foregoing with the SEC shall be deemed to satisfy the requirements of this Section 8.01(h) on the date on which such information is first available via the SEC’s EDGAR system or a successor system related thereto;

(i) as soon as possible and in any event within five (5) Business Days after the Borrower obtains knowledge of any Claim related to any Product of any Obligor that is reasonably likely to result in liability to the Borrower in excess of $500,000, written notice thereof from a Responsible Officer of the Borrower which notice shall include any statement setting forth details of such Claim;

(j) such other information respecting the operations, properties, business or condition (financial or otherwise) of the Obligors (including with respect to the Collateral) as the Administrative Agent may from time to time reasonably request; and

(k) within three (3) Business Days prior to the Tranche B Term Loan Borrowing Date, provide updated Schedules to this Agreement (if any);

provided , notwithstanding the foregoing, the Borrower covenants and agrees that neither the Borrower, nor any other Person acting on its behalf, will provide, or be obligated to provide, any Lender or its Representatives with any information that the Borrower believes constitutes material non-public information, unless prior thereto such Lender shall have confirmed to the Borrower in writing that it consents to receive such information.  The Borrower understands and confirms that each Lender shall be relying on the foregoing covenant in effecting transactions in securities of the Borrower.

Section 8.02. Notices of Material Events

.  The Borrower will furnish to the Administrative Agent written (or, in the case of Section 8.02(n), written or telephonic) notice of the following promptly (but in any event, except as otherwise set forth in 8.02(o), within five (5) Business Days) after a Responsible Officer obtains knowledge of the existence thereof (or as otherwise provided below):

(a) the occurrence of any Default or Event of Default;

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(b) the occurrence of any event with respect to any Obligor’s property or assets resulting in a Loss aggregating in excess of $500,000 (or the Equivalent Amount in other currencies determined at the time of such Loss);

(c) (i) any spillage, leakage, discharge, disposal, leaching, migration or release of any Hazardous Material required to be reported to any Governmental Authority under applicable Environmental Laws that would reasonably be expected to result in a liability in excess of $500,000 and (ii) all Claims, notices of violation, hearings, investigations or proceedings pending or, to the Borrower’s knowledge, threatened in writing against any Obligor or any of its Subsidiaries or with respect to the ownership, use, maintenance and operation of their respective businesses, operations or properties, relating to Environmental Laws or Hazardous Material, in each case that would reasonably be expected to result in a liability in excess of $500,000;

(d) the assertion in writing by any Person against any Obligor of any alleged violation of or non-compliance with any Environmental Laws or any permits, licenses or authorizations required pursuant to any Environmental Law which would reasonably be expected to result in liability to such Obligor in excess of $500,000;

(e) the filing or commencement of any action, suit or proceeding by or before any arbitrator or Governmental Authority against any Obligor or any of its Subsidiaries that would reasonably be expected to result in a Material Adverse Effect;

(f) (i) on or prior to any filing by any ERISA Affiliate of any notice of intent to terminate any Title IV Plan, a copy of such notice and (ii) promptly, and in any event within ten (10) days, after any Responsible Officer of any ERISA Affiliate knows or has reason to know that an ERISA Event has occurred, a notice (which may be made by telephone if promptly confirmed in writing) describing such ERISA Event and any action that any ERISA Affiliate proposes to take with respect thereto, together with (if applicable) a copy of any notice filed with the PBGC or the IRS pertaining thereto;

(g) (i) the termination of any Material Agreement that adversely affects the Lenders in any material respect, other than the termination of a Material Agreement on its scheduled termination date; (ii) the receipt by any Obligor or any of its Subsidiaries of any notice under any Material Agreement (and a copy thereof) which would reasonably be likely to result in a Material Adverse Effect; or (iii) the entering into of any new Material Agreement by an Obligor or any of its Subsidiaries;

(h) the reports and notices as required by the Security Documents;

(i) any material change in accounting policies or financial reporting practices by the Obligors unless otherwise disclosed by the Borrower in a filing with the SEC;

(j) any labor controversy against an Obligor or any of its Subsidiaries which would reasonably be likely to result in a Material Adverse Effect;

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(k) any licensing agreement or similar arrangement entered into by any Obligor or any of its Subsidiaries in connection with any material infringement or alleged material infringe ment of the Intellectual Property of another Person;

(l) any change to any Obligor’s or any of its Subsidiaries’ ownership or maintenance of Deposit Accounts, Securities Accounts and Commodity Accounts (other than Excluded Accounts), by delivering to the Administrative Agent a supplement to the Schedules to this Agreement and the Security Agreement, as applicable, setting forth a complete and correct list of all such accounts as of the date of such change;

(m) (i) any safety alerts, marketing suspensions, removals or similar actions conducted, to be undertaken, or issued by, any Obligor or any of its Subsidiaries or (ii) any material safety alerts, marketing suspensions, removals or similar actions conducted, to be undertaken, or issued by, any Obligor’s and any of its Subsidiaries’ agents, suppliers, licensors or licensees, as the case may be, in each case of (i) and (ii) above, whether voluntary or at the request, demand or order of any Regulatory Authority or otherwise with respect to any Product or Product Commercialization and Development Activity;

(n) any Claim by any Person that any Obligor or any of its Subsidiaries, including in connection with any Product Commercialization and Development Activities, has infringed upon any Intellectual Property of such Person, in each case to the extent such would reasonably be expected to cause a Material Adverse Effect;

(o) with respect to any “Grantor” under the Security Agreement, if such Grantor intends to (i) change its location (as defined in Section 9-307 of the UCC), or (ii) change its name from the name shown as its current legal name on Schedule 1 to the Security Agreement, the Borrower shall provide ten (10) days’ prior written notice to the Administrative Agent (or such shorter period as may be acceptable to Administrative Agent in its reasonable discretion); and

(p) any other development that results in, or would reasonably be expected to result in, a Material Adverse Effect.

Each notice delivered under this Section 8.02 shall be accompanied by a statement of a Responsible Officer of the Borrower setting forth in reasonable detail the event or development requiring such notice and any action taken or proposed to be taken with respect thereto.  Nothing in this Section 8.02 is intended to waive, consent to, or otherwise permit any action or omission that is otherwise prohibited by this Agreement or any other Loan Document.

Section 8.03. Existence; Conduct of Business

.  Such Obligor will, and will cause each of its Subsidiaries to, do or cause to be done all things necessary to preserve, renew and keep in full force and effect its legal existence and all Governmental Approvals material to the conduct of its business; provided that the foregoing shall not prohibit any transaction permitted under Section 9.03.

Section 8.04. Payment of Obligations

.  Such Obligor will, and will cause each of its Subsidiaries to, pay and discharge its obligations, including (i) all material Taxes, fees,

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assessments and governmental charges or levies imposed upon it or upon its properties or assets prior to the date o n which penalties attach thereto, and all material lawful Claims for labor, materials and supplies which, if unpaid, would become a Lien (other than a Permitted Lien) upon any properties or assets of such Obligor any of its Subsidiaries, except to the exte nt such Taxes, fees, assessments or governmental charges or levies are Permitted Liens and (ii) all other lawful Claims which, if unpaid, would by Law become a Lien (other than a Permitted Lien) upon any material properties or assets of such Obligor or any of its Subsidiaries, except to the extent any of the foregoing are being contested in good faith by appropriate proceedings and are adequately reserved against in accordance with GAAP.

Section 8.05. Insurance

.  At its own cost and expense, each Obligor will, and will cause each of its Subsidiaries, to obtain and maintain insurance of the kinds, and in the amounts, set forth below, it being understood and agreed that the insurance held by the Borrower on the Closing Date is deemed to fulfill this requirement:

(a) All Risks of Physical Loss Insurance .  Insurance against loss, destruction or damage to its properties and assets (including the Collateral) as determined in its good faith business judgment to be customary for companies similar to the Borrower.

(b) Commercial General Liability Insurance .  Commercial general liability insurance covering bodily injury, death, property damage, products liability in such amounts as are generally required by institutional lenders for businesses and assets comparable to the business and assets of the Borrower.

(c) Workers Compensation Insurance .  Workers’ compensation insurance with respect to any work performed on or about the property or assets of the Borrower.

(d) General Requirements .  All of the insurance policies of the Obligors required pursuant to this Section 8.05 will (i) be issued by financially sound and reputable insurers, and (ii) from and after the Closing Date (or such later date as agreed to by the Administrative Agent in its reasonable discretion), (x) name the Administrative Agent as a “loss payee,” “additional insured” or “mortgagee,” as applicable, and (y) provide for thirty (30) days’ prior written notice (ten (10) days’ prior written notice from the Borrower for nonpayment of premium) to the Administrative Agent before such policy is canceled or terminated.  In the event the Obligors fail to maintain the insurance required pursuant to this Section 8.05, then the Administrative Agent may obtain insurance necessary to comply with this Section 8.05 with respect to such Obligors, in each case at the expense of the Borrower (payable on demand).  The amount of any such expenses shall accrue interest at the Default Rate if not paid on demand, and shall constitute “Obligations.” All of the insurance policies required hereby will be evidenced by one or more certificates of insurance, together with appropriate loss payee or additional insured clauses or endorsements in favor of the Administrative Agent as required by this Section, delivered to the Administrative Agent at such times as the Administrative Agent may reasonably request from time to time.  Unless an Event of Default has occurred and is continuing, the Administrative Agent agrees to turn over to the Borrower any proceeds from insurance received by the Administrative Agent within fifteen (15) Business Days following its receipt of a notice by the Borrower of the Borrower’s intention to reinvest such proceeds as set forth in Section 3.04(b).

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Section 8.06. Books and Records; Inspection Rights

.  Such Obligor will, and will cause each of its Subsidiaries to, keep proper books of record and account in which full, true and correct in all material respects entries are made of all dealings and transactions in relation to any Product Commercialization and Development Activities.  Such Obligor will permit any representatives designated by the Administrative Agent, upon at least five (5) Business Days’ prior written notice and during normal business hours, to visit and inspect its properties, to examine and make extracts from its books and records (excluding records subject to attorney-client privilege, subject to confidentiality agreements with third parties that preclude disclosure to the Administrative Agent (acting in such capacity) or subject to confidentiality restrictions pursuant to Law (including HIPAA)) (provided that so long as no Event of Default has occurred and is continuing, the Administrative Agent shall visit and inspect properties, and examine and make extracts of books are records located only in the United States), and to discuss its affairs, finances and condition with its officers and independent accountants, all at such reasonable times (but not more often than once per year unless an Event of Default has occurred and is continuing) as the Administrative Agent may request.  The Borrower shall pay all reasonable and documented costs and expenses of all such inspections.

Section 8.07. Compliance with Laws and Other Obligations

.  (a) Such Obligor will, and will cause each of its Subsidiaries to, (i) comply in all material respects with all applicable Laws (including Healthcare Laws and Environmental Laws) and (ii) comply in all material respects with all terms of outstanding Material Indebtedness and all Material Agreements, except where the failure to do so, individually or in the aggregate, would not reasonably be expected to result in a Material Adverse Effect.

(b) Each Obligor will maintain, and will cause each of its Subsidiaries to maintain, all records required to be maintained by any Governmental Authority or otherwise under any applicable Healthcare Law, except where failure to do so would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.

(c) Each Obligor will maintain, and will cause each of its Subsidiaries to maintain, a Health Care Compliance Program, which will be reviewed and updated annually, as necessary.

Section 8.08. Maintenance of Properties, Etc

.  Such Obligor shall, and shall cause each of its Subsidiaries to, maintain and preserve all of its real and tangible personal property, including all such Product Assets, necessary in the conduct of its business in good working order and condition in accordance with the general practice of other Persons of similar character and size, ordinary wear and tear and damage from casualty or condemnation excepted.

Section 8.09. Maintenance of Regulatory Approvals and Material Intellectual Property

.  (a) Such Obligor shall, and shall cause each of its Subsidiaries to, maintain, in full force and effect in all material respects, each Regulatory Approval (including all Product Authorizations) required to conduct their respective businesses as presently conducted; provided that such Obligor or such Subsidiary shall not be required to preserve any such Regulatory Approval if such Obligor or such Subsidiary shall determine in its reasonable good faith judgment that the preservation thereof is no longer necessary in the conduct of any material Product Commercialization and Development Activities.

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(b) Such Obligor shall, and shall cause each of its Subsidiaries to, use commerciall y reasonable efforts to (i) protect and preserve all Material Intellectual Property necessary in the conduct of any material Product Commercialization and Development Activities and (ii) enforce or defend the Material Intellectual Property against infringe ment, misappropriation, violation or interference by any other Persons, in each case so that such Obligor’s Product Commercialization and Development Activities are not adversely affected in any material respect; provided that nothing in this Section 8.09( b) shall prohibit or prevent such Obligor or any Subsidiary from discontinuing the protection, preservation or maintenance of, or failing to enforce and defend, any of its Intellectual Property if, in the reasonable good faith judgment of such Obligor or s uch Subsidiary, such Intellectual Property is no longer necessary and material to the conduct of any material Product Commercialization and Development Activities.

Section 8.10. Action Under Environmental Laws

.  Such Obligor shall, and shall cause each of its Subsidiaries to, upon the Borrower obtaining knowledge of the release of any Hazardous Materials or the existence of any environmental liability under applicable Environmental Laws with respect to their respective businesses, operations or properties, take all actions, at their cost and expense, as shall be necessary or advisable to investigate and clean up the condition of their respective businesses, operations or properties, including all required removal, containment and remedial actions, and restore their respective businesses, operations or properties to a condition in each case in compliance with applicable Environmental Laws, except to the extent the failure to take such action would not reasonably be likely to result in a Material Adverse Effect.

Section 8.11. Use of Proceeds

.  The proceeds of the Loans will be used only as provided in Section 2.03.  Without limiting the foregoing, no part of the proceeds of the Loans will be used, whether directly or indirectly, for any purpose that entails a violation of any of the Regulations of the Board of Governors of the Federal Reserve System, including Regulations T, U and X.

Section 8.12. Certain Obligations Respecting Subsidiaries; Further Assurances.

(a) Subsidiary Guarantors .  In the event that the Borrower or any of its Domestic Subsidiaries shall form or acquire any new Subsidiary that is a Domestic Subsidiary, the Borrower and its Domestic Subsidiaries shall concurrently upon the capitalization thereof with more than $25,000:

(i) cause such new Domestic Subsidiary to become a “Subsidiary Guarantor” hereunder, and a “Grantor” under the Security Agreement, pursuant to a Guarantee Assumption Agreement;

(ii) take such action or cause such Domestic Subsidiary to take such action (including joining the Security Agreement, delivering such shares of stock together with undated transfer powers executed in blank and entering into the applicable Short-Form IP Security Agreements) as shall be necessary to create and perfect valid and enforceable first priority Liens (subject to Permitted Liens) on substantially all of the personal property of such new Domestic Subsidiary (other than Excluded Accounts) as collateral security for the obligations of such new Domestic Subsidiary hereunder;

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(iii) cause the parent of such Domestic Subsidiary to execute and deliver a pledge agr eement in favor of the Administrative Agent for the benefit of the Secured Parties in respect of all outstanding issued shares of such Domestic Subsidiary; and

(iv) deliver such proof of corporate or other organizational action, incumbency of officers, opinions of counsel and other documents as is consistent with those delivered by each Obligor pursuant to Section 6.01, or as the Administrative Agent shall have reasonably requested.

Notwithstanding anything to the contrary in this Agreement or any of the other Loan Documents, (i) no Foreign Subsidiary or Domestic Foreign Holding Company shall be a Guarantor, or be required to become a Guarantor, (ii) no assets of any Foreign Subsidiary or Domestic Foreign Holding Company shall be pledged, subjected to a Lien or the Security Documents or otherwise used to secure any of the Obligations, (iii) no more than 65% of the issued and outstanding Equity Interests entitled to vote (within the meaning of Treasury Regulation Section 1.956-2(c)(2)) of any Domestic Foreign Holding Company or Foreign Subsidiary that is, in each case, a direct first-tier Subsidiary of the Borrower or a Domestic Subsidiary shall be directly or indirectly pledged to guarantee or support any of the Obligations, and (iv) no Equity Interests in any Subsidiary of a Foreign Subsidiary or Domestic Foreign Holding Company shall be directly or indirectly pledged to guarantee or support any of the Obligations.

(b) Further Assurances .  Subject to the limitations set forth herein and in the other Loan Documents, such Obligor will, and will cause each of its Domestic Subsidiaries to, take such action from time to time as shall reasonably be requested by the Administrative Agent to effectuate the purposes and objectives of this Agreement.

Without limiting the generality of the foregoing, each Obligor will, and will cause each Person that is required to be a Subsidiary Guarantor to, take such action from time to time (including executing and delivering such assignments, security agreements, control agreements and other instruments) as shall be reasonably requested by the Administrative Agent to create, in favor of the Lenders, perfected security interests and Liens in substantially all of the personal property of such Obligor as collateral security for the Obligations; provided that any such security interest or Lien shall be subject to the relevant requirements of the Security Documents.  Notwithstanding anything to the contrary herein or in any other Loan Document, the Obligors (i) shall not be responsible for legal and filing costs, fees, expenses and other amounts in or with respect to any jurisdiction outside the United States in order to create or perfect any security interests in or Liens on any Intellectual Property other than Material Intellectual Property and (ii) shall only be responsible for legal and filing costs, fees, expenses and other amounts in or with respect to any jurisdiction outside the United States in order to create or perfect any security interests in or Liens on any Material Intellectual Property if reasonably requested in writing by the Administrative Agent.

Section 8.13. Termination of Non-Permitted Liens

.  In the event that the Borrower obtains knowledge of or receives notification from the Administrative Agent of the existence of any outstanding Lien against any property of such Obligor or any of its Subsidiaries, which Lien

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is not a Permitted Lien, such Obligor shall promptly terminate or cause the termination of such Lien.

Section 8.14. Intellectual Property

.  In the event that any Obligor acquires Obligor Intellectual Property during the term of this Agreement, then the provisions of this Agreement shall automatically apply thereto and any such Obligor Intellectual Property shall automatically constitute part of the Collateral under the Security Documents, without further action by any party, in each case from and after the date of such acquisition (except that any representations or warranties of any Obligor shall apply to any such Obligor Intellectual Property only from and after the date, if any, subsequent to such acquisition that such representations and warranties are brought down).

Section 8.15. ERISA Compliance

.  Such Obligor shall comply, and to the extent applicable, shall cause each of its Subsidiaries to comply, in all material respects with the provisions of ERISA with respect to any Title IV Plans and Multiemployer Plans to which such Obligor or any such Subsidiary is a party as employer.

Section 8.16. Cash Management.

(a) On and after the Closing Date (or such later date as agreed to by the Administrative Agent in its reasonable discretion), each Obligor shall maintain all Deposit Accounts, Securities Accounts, Commodity Accounts and lockboxes (other than Excluded Accounts) with a bank or financial institution that has executed and delivered to the Administrative Agent an account control agreement, in form and substance reasonably acceptable to the Administrative Agent (each such Deposit Account, Securities Account, Commodity Account and lockbox, a “ Controlled Account ”); provided that the foregoing covenant shall not apply to the Deposit Accounts specified on Schedule 8.16 until thirty (30) days after the Closing Date or such longer date as may be agreed to by the Administrative Agent in its sole discretion in writing (email acceptable);

(b) if, as of the last Business Day of any month, the Foreign Subsidiaries collectively hold a cash balance in excess of the sum of the following amounts (or the Equivalent Amount in other currencies):  (i) $500,000 plus (ii) the proceeds of any intercompany loan from an Obligor permitted pursuant to Section 9.01(e), such Foreign Subsidiaries shall, within five (5) Business Days thereafter, transfer and re-deposit with the Borrower or other Obligor any amount in excess of such sum, less any amounts determined by the Borrower to be necessary to meet the anticipated obligations of the Foreign Subsidiaries coming due the following month, into a Deposit Account of an Obligor (which Deposit Account shall, on and after the Closing Date (or such later date as agreed to by the Administrative Agent in its reasonable discretion), be a Controlled Account);

(c) the Obligors shall deposit promptly, and in any event no later than five (5) Business Days after the date of receipt thereof, all cash, checks, drafts or other similar items of payment relating to or constituting payments made in respect of any and all accounts and other rights and interests (including pursuant to clause (d) below) into a Deposit Account of an Obligor (which Deposit Account shall, on and after the Closing

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Date (or such later date as agreed to by the Administ rative Agent in its reasonable discretion), be a Controlled Account); and

(d) the Obligors shall (i) maintain policies and procedures that cause all items of payment or proceeds of Government Receivables Accounts, within two (2) Business Days of deposit into any such Government Receivables Account, to be transferred and re-deposited into a Deposit Account of an Obligor (which Deposit Account shall, on and after the Closing Date (or such later date as agreed to by the Administrative Agent in its reasonable discretion), be a Controlled Account), and (ii) on and after the Closing Date (or such later date as agreed to by the Administrative Agent in its reasonable discretion), cause all amounts deposited into the Government Receivables Accounts to be automatically swept on a daily basis to a Controlled Account pursuant to a sweep agreement with the depository bank in form and substance reasonably acceptable to the Administrative Agent (a “ Sweep Agreement ”) as and when funds clear and become available in accordance with the depository bank’s standard procedures; provided that the foregoing covenant shall not apply to the Deposit Accounts specified on Schedule 8.16 until thirty (30) days after the Closing Date or such longer date as may be agreed to by the Administrative Agent from time to time in its sole discretion in writing (email acceptable).  Any Sweep Agreement will provide that the depository bank will not change the automatic daily sweep instructions until at least five (5) days (or such lesser period as the Administrative Agent may agree in its sole discretion or as may be required by applicable Federal Health Care Program Laws) after receipt of such request from the applicable Obligor maintaining such Government Receivables Account, which request shall be acknowledged and agreed to in writing by the Administrative Agent in its sole discretion.

Section 8.17. Post-Closing Obligations

.  Within the time periods specified on Schedule 8.17 (as each may be extended by the Administrative Agent in its reasonable discretion), complete such undertakings as are set forth on Schedule 8.17.

SECTION 9.

Negative Covenants.

Each Obligor covenants and agrees with the Lenders that, until the Commitments have expired or been terminated and all Obligations (other than Warrant Obligations and contingent obligations as to which no claims have been asserted) have been paid in full indefeasibly in cash:

Section 9.01. Indebtedness

.  Such Obligor will not, and will not permit any of its Subsidiaries to, create, incur, assume or permit to exist any Indebtedness, whether directly or indirectly, except:

(a) the Obligations;

(b) (i) Indebtedness existing on the on the Closing Date and set forth on Schedule 7.13(a), together with, except in the case of the Pay-Off Indebtedness, any Permitted Refinancings thereof;

(c) accounts payable to trade creditors for goods and services and current operating liabilities (not the result of the borrowing of money) incurred in the ordinary

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course of such Obligor’s or such Subsidiary’s business in accordance with customary terms and paid within nine ty (90) days of becoming due, unless contested in good faith by appropriate proceedings and reserved for in accordance with GAAP;

(d) Indebtedness consisting of guarantees resulting from the endorsement of negotiable instruments for collection in the ordinary course of business;

(e) (i) Indebtedness of an Obligor to a Subsidiary or to any other Obligor, (ii) Indebtedness of any Subsidiary that is not an Obligor to any other Subsidiary that is not an Obligor and (iii) so long as no Event of Default has occurred and is continuing, Indebtedness of a Subsidiary that is not an Obligor to any Obligor in an aggregate amount not to exceed the following at any time outstanding:  (x) with respect to the period from the Closing Date through December 31, 2018, $2,000,000, (y) with respect to fiscal year 2019, $3,000,000, and (z) with respect to each fiscal year thereafter, an amount equal to such prior year’s threshold plus $500,000; provided , that all such Indebtedness shall be (A) evidenced by promissory notes and all such notes to the extent payable to an Obligor shall be subject to a first priority Lien pursuant to the Security Agreement, (B) unsecured, and (C) in the case of clause (i), subordinated in right of payment to the payment in full of the Obligations (other than the Warrant Obligations) pursuant to the terms of the applicable promissory notes or an intercompany subordination agreement, in each case form and substance satisfactory to the Administrative Agent in its sole discretion;

(f) Guarantees by (i) any Subsidiary of Indebtedness of any Obligor, (ii) any Obligor of Indebtedness of any other Obligor, and (iii) any Subsidiary that is not an Obligor of any Indebtedness of any other Subsidiary that is not an Obligor;

(g) Purchase money and capital lease financing; provided that (i) if secured, the collateral therefor consists solely of the assets being financed, the products and proceeds thereof and books and records related thereto, and (ii) the aggregate outstanding principal amount of such Indebtedness does not exceed $500,000 at any time;

(h) Indebtedness under Hedging Agreements permitted by Section 9.05(f);

(i) Indebtedness consisting of the financing of insurance premiums in respect of insurance policies insuring assets or businesses of an Obligor and/or its Subsidiaries written or arranged in the ordinary course of business, in each case in an amount not to exceed the amount of the applicable insurance premium in respect of any such policy plus interest and financing charges applicable thereto;

(j) Indebtedness in respect of any agreement providing for treasury, depositary or cash management services, including in connection with any credit cards, automated clearing house transfers of funds transaction, securities settlements, foreign exchange contracts or any similar transfers, netting services, overdraft protections and other cash management and similar arrangements, in each case in the ordinary course of business;

(k) advances or deposits from customers or vendors received in the ordinary course of business;

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(l) workers’ compensation claims, payment obligations in connection with health, disability or other types of social security benefits, unemployment or other insurance obligations and reclamation and statutory obligations, in each case incurred in the ordinary course o f business;

(m) Subordinated Indebtedness in an aggregate amount not to exceed $5,000,000 (or the Equivalent Amount in other currencies determined at the time such loan or advance is made);

(n) Indebtedness in the form of earnouts and purchase price adjustments incurred in connection with a Permitted Acquisition and Indebtedness of any Person the target of such Permitted Acquisition in aggregate amount not to exceed $1,000,000;

(o) Indebtedness consisting of letters of credit, letters of guaranty and bankers’ acceptances to the extent incurred in the ordinary course of business in an aggregate amount not to exceed $1,000,000;

(p) Indebtedness which may be deemed to exist pursuant to any guaranties, indemnities, performance, surety, statutory, appeal or similar obligations incurred in the ordinary course of business and Indebtedness constituting guaranties in the ordinary course of business of the obligations of suppliers, customers, franchisees and licensees of the Borrower and its Subsidiaries;

(q) Indebtedness in favor of customs and revenue authorities in connection with the payment of customs duties in connection with the importation of goods in the ordinary course of business;

(r) so long as no Default or Event of Default has occurred and is continuing at the time such Indebtedness is incurred, other Indebtedness in an aggregate principal amount not to exceed $500,000 at any time outstanding (but without giving effect to any fluctuations in the Exchange Rate from the date of incurrence); and

(s) to the extent considered Indebtedness, Investments permitted pursuant to Section 9.05.

Section 9.02. Liens

.  Such Obligor will not, and will not permit any of its Subsidiaries to, create, incur, assume or permit to exist any Lien on any property now owned or hereafter acquired by it or such Subsidiary, except:

(a) Liens securing the Obligations;

(b) (i) any Lien on any property or asset of such Obligor or any of its Subsidiaries existing on the Closing Date and set forth on Schedule 7.13(b); provided that (i) no such Lien shall extend to any other property or asset of such Obligor or any of its Subsidiaries other than that which it secures on the date hereof and any cross- collateralization of other assets financed with the same holder of such Lien, and (ii) any such Lien shall secure only those obligations which it secures on the Closing Date and

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extensions, renewals and replacements thereof that do not increase the outstanding principal amount thereof, plus fees and expenses incurred in connection therewith;

(c) Liens securing Indebtedness permitted by Section 9.01(g); provided that such Liens are limited solely to the assets, products, proceeds and books and records permitted to be secured pursuant to Section 9.01(g);

(d) Liens imposed by any applicable Law arising in the ordinary course of business, including (but not limited to) carriers’, warehousemen’s, landlord’s and mechanics’ liens and other similar Liens arising in the ordinary course of business;

(e) Liens, pledges or deposits made in the ordinary course of business in connection with leases, or bids, contracts, appeal bonds, workers’ compensation, unemployment insurance or other similar social security legislation, and not in connection with money borrowed;

(f) Liens securing Taxes, assessments and other governmental charges, the payment of which (i) is not yet delinquent or (ii) is being contested in good faith by appropriate proceedings promptly initiated and diligently conducted and for which adequate reserves have been made if required in accordance with GAAP;

(g) servitudes, easements, rights of way, restrictions and other similar encumbrances on real property imposed by any applicable Law and Liens consisting of zoning or building restrictions, easements, licenses, restrictions on the use of property or minor imperfections in title thereto which, in the aggregate, are not material, and which do not in any case materially detract from the value of the property subject thereto or interfere with the ordinary conduct of the business of any of the Obligors or any of their Subsidiaries;

(h) with respect to any real property, (i) such defects or encroachments as might be revealed by an up-to-date survey of such real property; (ii) the reservations, limitations, provisos and conditions expressed in the original grant, deed or patent of such property by the original owner of such real property pursuant to Laws; (iii) rights of expropriation, access or user or any similar right conferred or reserved by or in any Law, which, in the aggregate for clauses (i), (ii) and (iii), are not material, and which do not in any case materially detract from the value of the property subject thereto or interfere with the ordinary conduct of the business of any of the Obligors or their Subsidiaries; and (iv) leases or subleases in the ordinary course of business;

(i) bankers’ liens, rights of setoff, netting and similar Liens incurred on deposits made in the ordinary course of business or otherwise in connection with the services permitted by Section 9.01(j);

(j) Liens in connection with (i) licenses permitted by Section 9.13 and (ii) any ordinary course interest or title of a licensor, sublicensor, lessor or sublessor with respect to any assets under any inbound license or lease agreement permitted by Section 9.13;

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(k) deposits made in connection with a contemplated Permitted Acquisition in an aggregate amount not to exceed 10% of the consideration of such Acquisition;

(l) Liens arising as a matter of law to secure Indebtedness incurred pursuant to Section 9.01(q);

(m) Liens to the extent such does not constitute and Event of Default under Section 11.01(i);

(n) Liens incurred in connection with the Indebtedness permitted by Sections 9.01(n), 9.01(o) and 9.01(p);

(o) Liens on insurance policies and the proceeds thereof (excluding any benefits or any rights to receive payment under any insurance policies) incurred in connection with the financing in the ordinary course of business of insurance premiums, provided , that such Liens shall be limited only to the unused portion of the premiums payable under such insurance policies and the proceeds of such insurance premiums;

(p) (i) Restrictive Agreements permitted pursuant to Section 9.11, (ii) any customary provisions in contracts (including without limitation leases and licenses of Intellectual Property) restricting the assignment thereof or, in the case of any lease or license, the sublease or sublicense or other disposition of the applicable leased or licensed property, (iii) restrictions or conditions imposed by any agreement governing secured Permitted Indebtedness permitted under Section 9.01(g), to the extent that such restrictions or conditions apply only to the property or assets securing such Indebtedness and (iv) restrictions in agreements related to any Asset Sale to the extent such Asset Sale would be a permitted Asset Sale under this Agreement; and

(q) so long as no Default or Event of Default has occurred and is continuing at the time such Lien attaches, other Liens securing obligations in an aggregate amount not to exceed $500,000 at any time outstanding (but without giving effect to any fluctuations in the Exchange Rate from the date of incurrence);

provided that no Lien otherwise permitted under any of the foregoing clauses shall apply to any Material Intellectual Property except for Liens described in clauses (a), (j) and (p).

Section 9.03. Fundamental Changes and Acquisitions

.  Such Obligor will not, and will not permit any of its Subsidiaries to, (i) enter into any transaction of merger, amalgamation or consolidation, (ii) liquidate, wind up or dissolve itself (or suffer any liquidation or dissolution), (iii) make or consummate any Acquisition of any Person, or (iv) create any Subsidiary, except:

(a) transactions permitted by Section 9.01 and 9.05;

(b) the merger, amalgamation, consolidation, liquidation, winding up or dissolution of (i) any Subsidiary with or into any Obligor; provided that with respect to any such transaction involving the Borrower, the Borrower must be the surviving or successor entity of such transaction, and (ii) any Subsidiary that is not an Obligor with or into any other Subsidiary that is not an Obligor;

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(c) t he sale, lease, transfer or other disposition by (i) any Subsidiary of any or all of its property (upon voluntary liquidation or otherwise) to any Obligor and (ii) by any Subsidiary that is not an Obligor to any other Subsidiary that is not an Obligor;

(d) the sale, transfer or other disposition of the Equity Interests of any Subsidiary Guarantor to the Borrower;

(e) the creation of any Subsidiary subject to compliance with Section 8.12;

(f) the Acquisitions contemplated on the Closing Date and set forth on Schedule 9.03; and

(g) Permitted Acquisitions.

Section 9.04. Lines of Business

.  Such Obligor will not, and will not permit any of its Subsidiaries to, engage in any business other than the business engaged in on the date hereof by such Obligor or such Subsidiary or a business reasonably related, incidental or complimentary thereto or a reasonable extension thereof or a business having a similar customer base.

Section 9.05. Investments

.  Such Obligor will not, and will not permit any of its Subsidiaries to, make, directly or indirectly, or permit to remain outstanding any Investments except:

(a) Investments outstanding on the date hereof and identified in Schedule 9.05 and any modification, replacement, renewal or extension thereof to the extent not involving new or additional Investments;

(b) operating deposit accounts with banks and securities accounts with banks and other financial institutions that either qualify as an Excluded Account or comply with Section 8.16;

(c) extensions of credit in the nature of deposits, accounts receivable, trade debt granted or notes receivable arising from the purchase or sale of goods or services in the ordinary course of business and prepaid royalties and other credit extensions and advances arising in the ordinary course of business;

(d) Permitted Cash Equivalent Investments;

(e) Investments by (i) any Obligor in any other Obligor, (ii) any Subsidiary that is not an Obligor in any other Subsidiary that is not an Obligor, and (iii) any Obligor or Subsidiary solely to the extent permitted by Section 9.01(e);

(f) Hedging Agreements entered into in by any Obligor or its Subsidiary in the ordinary course of business for the purpose of hedging currency risks or interest rate risks (and not for speculative purposes) not to exceed $2,000,000 (or the Equivalent Amount in other currencies) in the aggregate outstanding at any time;

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(g) Investments consisting of prepaid expenses, negotiable instruments held for collection or deposit, security deposits with utilities, landlords and other like Persons and deposits in connection with workers’ compensation and similar deposits, in each case made in the ordinary course of business;

(h) loans, advances and guarantees to or in favor of employees, officers, directors and consultants in the ordinary course of business which in the aggregate shall not exceed $500,000 outstanding at any time (or the Equivalent Amount in other currencies determined at the time such loan, advance or guarantee was made);

(i) Investments (i) in connection with a Permitted Acquisition and (ii) in connection with Casualty Events permitted by Section 3.04(b);

(j) Investments received in connection with any Insolvency Proceedings in respect of any customers, suppliers or clients or in settlement of delinquent obligations of, and other disputes with, customers, suppliers or clients;

(k) Investments made by the Obligor on the Tranche A Term Loan Borrowing Date with the proceeds of the Tranche A Term Loans made on such date the purpose of which is to repay the Pay-Off Indebtedness in full;

(l) Investments permitted by Sections 9.01, 9.02, 9.03, 9.06 and 9.09;

(m) Investments in newly created Domestic Subsidiaries to the extent such Subsidiary complies with Section 8.12 to the extent applicable; and

(n) so long as no Default or Event of Default has occurred and is continuing at the time such Investments are made, other Investments in an aggregate principal amount not to exceed $500,000 at any time outstanding (but without giving effect to any fluctuations in the Exchange Rate from the date of incurrence).

Section 9.06. Restricted Payments

.  Such Obligor will not, and will not permit any of its Subsidiaries to, declare or make, or agree to pay or make, directly or indirectly, any Restricted Payment; provided that the following Restricted Payments shall be permitted:

(a) distributions with respect to the Borrower’s Equity Interests payable solely in shares of its Qualified Equity Interests (or the equivalent thereof);

(b) the Borrower’s purchase, redemption, retirement, or other acquisition of shares of its Equity Interests with the proceeds received from a substantially concurrent issue of new shares of its Qualified Equity Interests;

(c) so long as no Event of Default has occurred and is continuing, payments pursuant to stock plans or stock repurchase agreements in an amount not to exceed $500,000 per fiscal year;

(d) so long as no Event of Default has occurred and is continuing, cash in lieu of the issuance of fractional shares upon the conversion of convertible securities (or in

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connection with the exercise of warrants or similar securities) not to exceed $100,000 in the aggregate;

(e) any non-cash (other than cash in lieu of fractional shares) conversion or exercise requests in respect of any convertible securities, options or warrants of the Borrower into Equity Interests of the Borrower pursuant to the terms of such convertible securities, options or warrants or otherwise in exchange therefor;

(f) distributions paid by any Subsidiary directly or indirectly to any Obligor or Subsidiary thereof;

(g) the payment in full of the Pay-Off Indebtedness;

(h) cash payments made to redeem, purchase, repurchase or retire the Warrant Obligations in accordance with the terms of the Warrants; and

(i) solely to the extent considered a Restricted Payment, Investments permitted pursuant to Section 9.05 and transactions permitted pursuant to Section 9.03.

Section 9.07. Payments of Subordinated Indebtedness

.  Such Obligor will not, and will not permit any of its Subsidiaries to, make any payments in respect of any Subordinated Indebtedness other than as permitted by any subordination agreement with Administrative Agent entered into in connection therewith.

Section 9.08. Change in Fiscal Year

.  Such Obligor will not, and will not permit any of its Subsidiaries to, change the last day of its fiscal year from that in effect on the date hereof, except to change the fiscal year of a Subsidiary acquired in connection with a Permitted Acquisition to conform its fiscal year to that of the Borrower.

Section 9.09. Sales of Assets, Etc

.  Such Obligor will not, and will not permit any of its Subsidiaries to, sell, lease, transfer, or otherwise dispose of any of its assets or property (including accounts receivable and capital stock of Subsidiaries), or forgive, release or compromise any amount owed to such Obligor or Subsidiary, in each case, in any single transaction or series of transactions (any thereof, an “ Asset Sale ”):

(a) sales or leases of inventory in the ordinary course of its business on ordinary business terms;

(b) the forgiveness, release, discounts or compromise of any amount owed to any Obligor or Subsidiary in the ordinary course of business;

(c) Asset Sales that constitute outbound licenses permitted pursuant to Section 9.13(b);

(d) transfers of assets or property by (i) any Subsidiary to any Obligor, (ii) any Obligor to any other Obligor, and (iii) by any Subsidiary that is not an Obligor to any other Subsidiary that is not an Obligor;

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(e) disposition s of any assets or property that is obsolete or worn out or no longer used or useful in the Business;

(f) dispositions resulting from Casualty Events;

(g) in connection with any transaction permitted by Sections 9.02, 9.03, 9.05 and 9.06;

(h) disposition of cash or Permitted Cash Equivalents; and

(i) so long as no Default or Event of Default has occurred and is continuing at the time of such sale, other Asset Sales not to exceed $500,000 (or the Equivalent Amount in other currencies determined at the time of such Asset Sale) in the aggregate per fiscal year.

Section 9.10. Transactions with Affiliates

.  Such Obligor will not, and will not permit any of its Subsidiaries to, sell, lease, license or otherwise transfer any assets to, or purchase, lease, license or otherwise acquire any assets from, or otherwise engage in any other transactions with, any of its Affiliates, except:

(a) transactions between or among (i) Obligors (other than any Person that is required to become a Subsidiary Guarantor pursuant to Section 8.12(a) or 8.12(b) but has not yet done so) and (ii) Subsidiaries that are not Obligors;

(b) any transaction permitted by Section 9.01, 9.03, 9.05, 9.06 or 9.09;

(c) customary compensation and indemnification of, and other employment arrangements with, directors, officers and employees of such Obligor or any of its Subsidiaries in the ordinary course of business;

(d) other transactions having terms that are no less favorable (including the amount of cash or other consideration received or paid by any Obligor) to any Obligor or any of its Subsidiaries, as the case may be, than those that would be obtained in a comparable arm’s-length transaction with a Person not an Affiliate of such Person; and

(e) the transactions set forth on Schedule 9.10.

Section 9.11. Restrictive Agreements

.  Such Obligor will not, and will not permit any of its Subsidiaries to, directly or indirectly, enter into, incur or be a party to any Restrictive Agreement; provided that the foregoing shall not apply to (i) restrictions and conditions imposed by Law or the Loan Documents and (ii) any Restrictive Agreement to which any Obligor or any of its Subsidiaries is party on the date hereof and that is listed on Schedule 7.15.

Section 9.12. Modifications and Terminations of Material Agreements and Organic Documents

.  Such Obligor will not, and will not permit any of its Subsidiaries to:

(a) amend, modify or terminate any Organic Document that adversely affects the Lenders (solely in their capacity as Lenders and not as shareholders) in any material

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respect without the prior written consent of the Administrative Agent which shall not be unreasonably withheld, conditioned or delayed; or

(b) knowingly take or omit to take any action that results in the termination of, or permits any other Person to terminate, any Material Agreement that adversely affects the Lenders in any material respect, without the prior written consent of the Administrative Agent which shall not be unreasonably withheld, conditioned or delayed.

Section 9.13. Inbound and Outbound Licenses.

(a) Inbound Licenses .  Except as set forth on Schedule 9.13(a), no Obligor will, nor will it permit any of its Subsidiaries to, enter into or become or remain bound by any inbound license or agreement unless (i) on the date such license is entered into, no Default or Event of Default has occurred and is continuing, (ii) such Obligor has provided written notice to the Administrative Agent of the material terms of such license or agreement with a description of its anticipated and projected impact on such Obligor’s business or financial condition, and (iii) such Obligor has taken such commercially reasonable actions as the Administrative Agent may reasonably request to obtain the consent of, or waiver by, any Person whose consent or waiver is necessary for the Administrative Agent to be granted a valid and perfected security interest in such license or agreement allowing the Lenders to fully exercise their rights under any of the Loan Documents in the event of a disposition or liquidation of the rights, assets or property that is the subject of such license or agreement; provided that the aggregate consideration paid for all such inbound licenses pursuant to this Section 9.13(a) shall not exceed an amount equal to $2,000,000 per fiscal year; provided further that inbound licenses of over-the-counter software that is commercially available to the public shall not be subject to the provisions of this Section 9.13(a).

(b) Outbound Licenses .  Except as set forth on Schedule 9.13(b), no Obligor will, nor will it permit any of its Subsidiaries to, enter into or become or remain bound by any outbound license of Material Intellectual Property unless such outbound license:  (i) is duly authorized by the Borrower pursuant to its customary approval process and has been entered into on an arm’s-length basis, on commercially reasonable terms and in the ordinary course of business, (ii) does not otherwise constitute an Asset Sale prohibited pursuant to Section 9.09, (iii) to the extent such Intellectual Property constitutes Collateral, does not impair the Administrative Agent or the Lenders from fully exercising their rights under any of the Loan Documents in the event of a disposition or liquidation (including in connection with a foreclosure) of the rights, assets or property retained by such Obligor or Subsidiary that is the subject of such license, (iv) solely with respect to licenses granted in the United States, is not an exclusive license (whether as to use, geography or otherwise), (v) is not perpetual and (vi) no Event of Default has occurred and continuing at the time of such license.

Section 9.14. Sales and Leasebacks

.  Except as disclosed on Schedule 9.14, such Obligor will not, and will not permit any of its Subsidiaries to, become liable, directly or indirectly, with respect to any lease, whether an operating lease or a Capital Lease Obligation, of any property (whether real, personal, or mixed), whether now owned or hereafter acquired, (i) which such Person has sold or transferred or is to sell or transfer to any other Person and

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(ii) which such Obligor or Subsidiary intends to us e for substantially the same purposes as property which has been or is to be sold or transferred.

Section 9.15. Hazardous Material

.  Such Obligor will not, and will not permit any of its Subsidiaries to, use, generate, manufacture, install, treat, release, store or dispose of any Hazardous Material, except in compliance with all applicable Environmental Laws or where the failure to comply would not reasonably be expected to result in a Material Adverse Effect.

Section 9.16. Accounting Changes

.  Such Obligor will not, and will not permit any of its Subsidiaries to, make any significant change in accounting treatment or reporting practices, except as required or permitted by GAAP.

Section 9.17. Compliance with ERISA

.  No ERISA Affiliate shall cause or suffer to exist (i) any ERISA Event that would reasonably be expected to result in the imposition of a Lien under ERISA or Code Section 430(k) on the assets or property of any Obligor or any of its Subsidiaries or (ii) any other ERISA Event that would reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.

SECTION 10.

Financial Covenants.

Section 10.01. Minimum Liquidity

.  The Borrower shall at all times maintain a minimum aggregate balance of $3,000,000 in cash in one or more accounts (which accounts shall, on and after the Closing Date (or such later date as agreed to by the Administrative Agent in its reasonable discretion), be Controlled Accounts), free and clear of all Liens, other than Liens granted hereunder in favor of the Administrative Agent and other Permitted Liens.

Section 10.02. Minimum Product Revenue

.  On each date set forth below (a “ Calculation Date ”) under the heading “Calculation Date,” the consolidated Product Revenue of the Borrower and its Subsidiaries for the period of four (4) consecutive fiscal quarters ended on such Calculation Date shall not be less than the amount set forth opposite such Calculation Date:

Calculation Date

Product Revenue

March 31, 2018

$48,000,000

June 30, 2018

$50,000,000

September 30, 2018

$50,000,000

December 31, 2018

$50,000,000

March 31, 2019

$50,000,000

June 30, 2019

$50,000,000

September 30, 2019

$50,000,000

December 31, 2019

$50,000,000

March 31, 2020

$50,000,000

June 30, 2020

$50,000,000

September 30, 2020

$50,000,000

December 31, 2020

$50,000,000

March 31, 2021

$50,000,000

June 30, 2021

$50,000,000

September 30, 2021

$50,000,000

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Calculation Date

Product Revenue

December 31, 2021

$50,000,000

March 31, 2022

$50,000,000

June 30, 2022

$50,000,000

September 30, 2022

$50,000,000

December 31, 2022

$50,000,000

March 31, 2023

$50,000,000

 

SECTION 11.

Events of Default.

Section 11.01. Events of Default

.  Each of the following events shall constitute an “ Event of Default ”:

(a) Principal or Interest Payment Default .  The Borrower shall fail to pay any principal of the Loans, when and as the same shall become due and payable, whether at the due date thereof or otherwise.

(b) Other Payment Defaults .  Any Obligor shall fail to pay any Obligation (other than an amount referred to in Section 11.01(a)) when and as the same shall become due and payable, and such failure shall continue unremedied for a period of three (3) Business Days.

(c) Representations and Warranties .  Any representation or warranty made or deemed made by or on behalf of any Obligor in this Agreement or any other Loan Document or any amendment or modification hereof or thereof, or in any report, certificate, financial statement or other document furnished pursuant to or in connection with this Agreement or any other Loan Document or any amendment or modification hereof or thereof, shall:  (i) prove to have been incorrect when made or deemed made to the extent that such representation or warranty contains any materiality or Material Adverse Effect qualifier; or (ii) prove to have been incorrect in any material respect when made or deemed made to the extent that such representation or warranty does not otherwise contain any materiality or Material Adverse Effect qualifier.

(d) Certain Covenants .  Any Obligor shall fail to observe or perform any covenant, condition or agreement contained in Sections 8.03 (with respect to the Borrower’s existence), 8.11, 8.12, 8.16, Section 9 or Section 10.

(e) Other Covenants .  Any Obligor shall fail to observe or perform any covenant or agreement contained in this Agreement (other than those specified in Section 11.01(a), (b) or (d)) or any other Loan Document, and, in the case of any failure that is capable of cure, such failure shall continue unremedied for a period of thirty (30) or more days.

(f) Reserved.

(g) Other Defaults on Other Indebtedness.  Any event or condition occurs (x) that results in any Material Indebtedness becoming due prior to its scheduled maturity

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or (y) that enables or permits (with or without the giving of notice, the lapse of time or both) the holder or holders of such Material Indebtedness or any trustee or agent on its or their behalf to cause such Material Indebtedness to become due, or to require the prepayment, repurchase, redemption or defeasance thereof, prior to its scheduled maturity; provided that this Section 11.01(g) shall not apply to secured Indebtedness that becomes due as a result of the volunta ry sale or transfer of the property or assets securing such Material Indebtedness; provided further that if the holder or holders of such Material Indebtedness or any trustee or agent on its or their behalf waives any such event or condition within the tim e period set forth therein, then such event or condition shall not be an Event of Default hereunder.

(h) Insolvency, Bankruptcy, Etc .  (i) Any Obligor or any of its Subsidiaries generally does not pay its debts as the same become due or admits in writing its inability to pay its debts generally; (ii) any Obligor or any of its Subsidiaries institutes any Insolvency Proceeding; (iii) any Obligor or any of its Subsidiaries takes any corporate action to approve, effect, consent to or authorize any of the actions described in Section 11.01(h)(ii); or (vi) any Insolvency Proceeding is filed against any Obligor or any of its Subsidiaries and, such Insolvency Proceeding continues undismissed, or unstayed and in effect, for a period of sixty (60) days after the institution thereof.

(i) Judgments .  One (1) or more judgments for the payment of money in an aggregate amount in excess of $1,000,000 (or the Equivalent Amount in other currencies determined at the time such judgment was entered) (to the extent not covered by independent third party insurance as to which the insurer has been notified of the potential claim and does not dispute coverage) shall be rendered against any Obligor or any of its Subsidiaries or any combination thereof and the same shall remain undismissed, unsatisfied or undischarged for a period of sixty (60) consecutive calendar days during which execution shall not be effectively stayed.

(j) ERISA and Pension Plans .  An ERISA Event shall have occurred that, in the reasonable determination of the Administrative Agent, when taken together with all other ERISA Events that have occurred, would reasonably be expected to result in the imposition of a Lien (other than a Permitted Lien) under ERISA or Code Section 430(k) on a material portion of the assets or property of any Obligor or any of its Subsidiaries or have a Material Adverse Effect.

(k) Change of Control, Etc .  A Change of Control shall have occurred.

(l) Material Adverse Change .  A Material Adverse Change shall have occurred.

(m) Impairment of Security, Etc .  If any of the following events occurs:  (i) Any Lien created by any of the Security Documents, shall at any time not constitute a valid and perfected Lien on the applicable Collateral in favor of the Secured Parties, free and clear of all other Liens (other than Permitted Liens) to the extent required by the Loan Documents, except due to the action or inaction of the Administrative Agent, (ii) except for expiration in accordance with its terms, any of the Security Documents or

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any Guarantee of any of the Obligations (including that contained in Section 12) shall for whatever reason cease to be in full force and effect, or (iii) any Obligor shall, directly or indirectly, contest in any manner such effectiveness, validity, binding nature or enforceability of any such Li en or any Loan Document.

(n) Regulatory Matters, Etc .  (i) The FDA or any other Regulatory Authority initiates enforcement action against, or issues a warning letter with respect to, any Obligor or any of its Subsidiaries, any material Product or any material Product Asset related thereto that causes such Person to discontinue the provision or sale of such Product, which discontinuance (x) lasts or would reasonably be expected to last for more than ninety (90) days and (y) results or would reasonably be expected to result in (A) a “stock-out” of such Product or (B) the loss of more than twenty percent (20%) of the Borrower’s revenue for the twelve (12) month period following such discontinuance as compared to the same period ending on the same date in the prior period, or (ii) any Obligor enters into a settlement agreement with the FDA or any other Regulatory Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, in excess of $1,000,000 to the extent not covered by insurance.

Section 11.02. Remedies

.  Upon the occurrence of any Event of Default (other than an Event of Default described in Section 11.01(h)), then, and in every such event, and at any time thereafter during the continuance of such event, the Administrative Agent may, by notice to the Borrower, declare the Loans then outstanding to be due and payable in whole (or in part, in which case any principal not so declared to be due and payable may thereafter be declared to be due and payable), and thereupon the principal of the Loans so declared to be due and payable, together with accrued interest thereon and all fees and other Obligations, shall become due and payable immediately (in the case of the Loans, at the Prepayment Price therefor), without presentment, demand, protest or other notice of any kind, all of which are hereby waived by each Obligor; and in case of an Event of Default described in Section 11.01(h), the principal of the Loans then outstanding, together with accrued interest thereon and all fees and other Obligations, shall automatically become due and payable immediately (in the case of the Loans, at the Prepayment Price therefor), without presentment, demand, protest or other notice of any kind, all of which are hereby waived by each Obligor.

Section 11.03. Reserved.

Section 11.04. Exit Fee, Prepayment Premium and Redemption Price

.  For the avoidance of doubt, the Exit Fee and the applicable Prepayment Premium (as a component of the Prepayment Price) shall be due and payable at any time the Loans become due and payable in full prior to the Maturity Date in accordance with the terms hereof, whether due to acceleration pursuant to the terms of this Agreement (in which case it shall be due immediately, upon the giving of notice to the Borrower or automatically by operation of law or otherwise in accordance with Section 11.02) (including, without limitation, on account of any bankruptcy filing).  In view of the impracticability and extreme difficulty of ascertaining the actual amount of damages to the Lenders or profits lost by the Lenders as a result of such acceleration, and by mutual agreement of the parties as to a reasonable estimation and calculation of the lost profits or damages of the Lenders, the Exit Fee and the Prepayment Premium shall be due and payable upon such date.  

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Each Obligor hereby waives any defense to payment, whether such defense may be based in public policy, ambiguity, or otherwise.  The Obligors and the Lenders acknowledge and agree that neither the Exit Fee nor any Prepayment Premium due and payabl e in accordance with this Agreement shall constitute unmatured interest, whether under Section 5.02(b)(3) of the Bankruptcy Code or otherwise.  Each Obligor further acknowledges and agrees, and waives any argument to the contrary, that payment of such amou nt does not constitute a penalty or an otherwise unenforceable or invalid obligation.

SECTION 12.

Guarantee.

Section 12.01. The Guarantee

.  The Subsidiary Guarantors hereby jointly and severally guarantee to the Administrative Agent and the Lenders, and their successors and assigns, the prompt payment in full when due (whether at stated maturity, by acceleration or otherwise) of the principal of and interest on the Loans, all fees and other amounts and Obligations from time to time owing to the Administrative Agent and the Lenders by the Borrower and each other Obligor under this Agreement or under any other Loan Document, in each case strictly in accordance with the terms hereof and thereof (such obligations being herein collectively called the “ Guaranteed Obligations ”).  The Subsidiary Guarantors hereby further jointly and severally agree that if the Borrower or any other Obligor shall fail to pay in full when due (whether at stated maturity, by acceleration or otherwise) any of the Guaranteed Obligations, the Subsidiary Guarantors will promptly pay the same, without any demand or notice whatsoever, and that in the case of any extension of time of payment or renewal of any of the Guaranteed Obligations, the same will be promptly paid in full when due (whether at extended maturity, by acceleration or otherwise) in accordance with the terms of such extension or renewal.

Section 12.02. Obligations Unconditional

.  The obligations of the Subsidiary Guarantors under Section 12.01 are absolute and unconditional, joint and several, irrespective of the value, genuineness, validity, regularity or enforceability of the obligations of the Borrower under this Agreement or any other agreement or instrument referred to herein, or any substitution, release or exchange of any other guarantee of or security for any of the Guaranteed Obligations, and, to the fullest extent permitted by Law, irrespective of any other circumstance whatsoever that might otherwise constitute a legal or equitable discharge or defense of a surety or guarantor, it being the intent of this Section 12.02 that the obligations of the Subsidiary Guarantors hereunder shall be absolute and unconditional, joint and several, under any and all circumstances.  Without limiting the generality of the foregoing, it is agreed that the occurrence of any one or more of the following shall not alter or impair the liability of the Subsidiary Guarantors hereunder, which shall remain absolute and unconditional as described above:

(a) at any time or from time to time, without notice to the Subsidiary Guarantors, the time for any performance of or compliance with any of the Guaranteed Obligations shall be extended, or such performance or compliance shall be waived;

(b) any of the acts mentioned in any of the provisions of this Agreement or any other agreement or instrument referred to herein shall be done or omitted;

(c) the maturity of any of the Guaranteed Obligations shall be accelerated, or any of the Guaranteed Obligations shall be modified, supplemented or amended in any

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respect, or any right under this Agreement or any othe r agreement or instrument referred to herein shall be waived or any other guarantee of any of the Guaranteed Obligations or any security therefor shall be released or exchanged in whole or in part or otherwise dealt with; or

(d) any lien or security interest granted to, or in favor of, the Secured Parties as security for any of the Guaranteed Obligations shall fail to be perfected.

The Subsidiary Guarantors hereby expressly waive diligence, presentment, demand of payment, protest and all notices whatsoever, and any requirement that the Administrative Agent or any Lender exhaust any right, power or remedy or proceed against the Borrower under this Agreement or any other agreement or instrument referred to herein, or against any other Person under any other guarantee of, or security for, any of the Guaranteed Obligations.

Section 12.03. Reinstatement

.  The obligations of the Subsidiary Guarantors under this Section 12 shall be automatically reinstated if and to the extent that for any reason any payment by or on behalf of the Borrower in respect of the Guaranteed Obligations is rescinded or must be otherwise restored by any holder of any of the Guaranteed Obligations, whether as a result of any proceedings in bankruptcy or reorganization or otherwise, and the Subsidiary Guarantors jointly and severally agree that they will indemnify the Administrative Agent and the Lenders on demand for all reasonable costs and expenses (including the reasonable and documented fees of counsel) incurred by such Persons in connection with such rescission or restoration, including any such costs and expenses incurred in defending against any claim alleging that such payment constituted a preference, fraudulent transfer or similar payment under any bankruptcy, insolvency or similar Law.

Section 12.04. Subrogation

.  The Subsidiary Guarantors hereby jointly and severally agree that, until the payment and satisfaction in full of all Guaranteed Obligations and the expiration and termination of the Commitments, they shall not exercise any right or remedy arising by reason of any performance by them of their guarantee in Section 12.01, whether by subrogation or otherwise, against the Borrower or any other guarantor of any of the Guaranteed Obligations or any security for any of the Guaranteed Obligations.

Section 12.05. Remedies

.  The Subsidiary Guarantors jointly and severally agree that, as between the Subsidiary Guarantors, on one hand, and the Administrative Agent and the Lenders, on the other hand, the obligations of the Borrower under this Agreement and under the other Loan Documents may be declared to be forthwith due and payable as provided in Section 11 (and shall be deemed to have become automatically due and payable in the circumstances provided in Section 11) for purposes of Section 12.01 notwithstanding any stay, injunction or other prohibition preventing such declaration (or such obligations from becoming automatically due and payable) as against the Borrower and that, in the event of such declaration (or such obligations being deemed to have become automatically due and payable), such obligations (whether or not due and payable by the Borrower) shall forthwith become due and payable by the Subsidiary Guarantors for purposes of Section 12.01.

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Section 12.06. Reserved.

Section 12.07. Continuing Guarantee

.  The guarantee in this Section 12 is a continuing guarantee, and shall apply to all Guaranteed Obligations whenever arising.

Section 12.08. Rights of Contribution

.  The Subsidiary Guarantors hereby agree, as between themselves, that if any Subsidiary Guarantor shall become an Excess Funding Guarantor (as defined below) by reason of the payment by such Subsidiary Guarantor of any Guaranteed Obligations, each other Subsidiary Guarantor shall, on demand of such Excess Funding Guarantor (but subject to the next sentence), pay to such Excess Funding Guarantor an amount equal to such Subsidiary Guarantor’s Fair Share (as defined below and determined, for this purpose, without reference to the properties, debts and liabilities of such Excess Funding Guarantor) of the Excess Payment (as defined below) in respect of such Guaranteed Obligations.  The payment obligation of a Subsidiary Guarantor to any Excess Funding Guarantor under this Section 12.08 shall be subordinate and subject in right of payment to the prior payment in full of the obligations of such Subsidiary Guarantor under the other provisions of this Section 12 and such Excess Funding Guarantor shall not exercise any right or remedy with respect to such excess until payment and satisfaction in full of all of such obligations.

For purposes of this Section 12.08, (i) “ Excess Funding Guarantor ” means, in respect of any Guaranteed Obligations, a Subsidiary Guarantor that has paid an amount in excess of its Fair Share of such Guaranteed Obligations, (ii) “ Excess Payment ” means, in respect of any Guaranteed Obligations, the amount paid by an Excess Funding Guarantor in excess of its Fair Share of such Guaranteed Obligations and (iii) “ Fair Share ” means, for any Subsidiary Guarantor, the ratio (expressed as a percentage) of (x) the amount by which the aggregate present fair saleable value of all properties of such Subsidiary Guarantor (excluding any shares of stock of any other Subsidiary Guarantor) exceeds the amount of all the debts and liabilities of such Subsidiary Guarantor (including contingent, subordinated, unmatured and unliquidated liabilities, but excluding the obligations of such Subsidiary Guarantor hereunder and any obligations of any other Subsidiary Guarantor that have been guaranteed by such Subsidiary Guarantor) to (y) the amount by which the aggregate fair saleable value of all properties of all of the Subsidiary Guarantors exceeds the amount of all the debts and liabilities (including contingent, subordinated, unmatured and unliquidated liabilities, but excluding the obligations of the Borrower and the Subsidiary Guarantors hereunder and under the other Loan Documents) of all of the Subsidiary Guarantors, determined (A) with respect to any Subsidiary Guarantor that is a party hereto on the Closing Date, as of the Closing Date, and (B) with respect to any other Subsidiary Guarantor, as of the date such Subsidiary Guarantor becomes a Subsidiary Guarantor hereunder.

Section 12.09. General Limitation on Guarantee Obligations

.  In any action or proceeding involving any provincial, territorial or state corporate law, or any state or federal bankruptcy, insolvency, reorganization or other law affecting the rights of creditors generally, if the obligations of any Subsidiary Guarantor under Section 12.01 would otherwise, taking into account the provisions of Section 12.08, be held or determined to be void, invalid or unenforceable, or subordinated to the claims of any other creditors, on account of the amount of its liability under Section 12.01, then, notwithstanding any other provision hereof to the contrary, the amount of such liability shall, without any further action by such Subsidiary Guarantor, the

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Administrative Agent, any Lender or any other Person, be automatically limited and reduced to the highest amount that is valid and enforceable and not subordinated to the claims of other cre ditors as determined in such action or proceeding.

SECTION 13.

Administrative Agent.

Section 13.01. Appointment

.  Each of the Lenders hereby irrevocably appoints Perceptive Credit Holdings II, LP, a Delaware limited partnership, to act on its behalf as the Administrative Agent hereunder and under the other Loan Documents and authorizes the Administrative Agent to take such actions on its behalf and to exercise such powers as are delegated to the Administrative Agent by the terms hereof or thereof, together with such actions and powers as are reasonably incidental thereto.  The provisions of this Section 13 are solely for the benefit of the Administrative Agent and the Lenders, and neither the Borrower nor any other Obligor will have rights as a third-party beneficiary of any of such provisions.  It is understood and agreed that the use of the term “agent” herein or in any other Loan Documents (or any other similar term) with reference to the Administrative Agent is not intended to connote any fiduciary or other implied (or express) obligations arising under agency doctrine of any applicable Law.  Instead, such term is used as a matter of market custom, and is intended to create or reflect only an administrative relationship between contracting parties.

Section 13.02. Rights as a Lender

.  The Person serving as the Administrative Agent hereunder will have the same rights and powers in its capacity as a Lender as any other Lender and may exercise the same as though it were not the Administrative Agent, and the term “Lender” or “Lenders” will, unless otherwise expressly indicated or unless the context otherwise requires, include the Person serving as the Administrative Agent hereunder in its individual capacity to the extent such Person is a Lender.  Such Person and its Affiliates may accept deposits from, lend money to, own securities of, act as the financial advisor or in any other advisory capacity for, and generally engage in any kind of business with, the Borrower, the other Obligors or any other Subsidiaries or Affiliates of the Obligors as if such Person were not the Administrative Agent hereunder and without any duty to account therefor to the Lenders.

Section 13.03. Exculpatory Provisions

.  (a) The Administrative Agent will not have any duties or obligations except those expressly set forth herein and in the other Loan Documents, and its duties hereunder are administrative in nature.  Without limiting the generality of the foregoing, the Administrative Agent:

(i) will not be subject to any fiduciary or other implied duties, regardless of whether a Default has occurred and is continuing;

(ii) will not have any duty to take any discretionary action or exercise any discretionary powers, except discretionary rights and powers expressly contemplated hereby or by the other Loan Documents that the Administrative Agent is required to exercise as directed in writing by the Majority Lenders (or such other number or percentage of the Lenders as will be expressly provided for herein or in the other Loan Documents); provided that the Administrative Agent will not be required to take any action that, in its opinion or the opinion of its counsel, may expose the Administrative Agent to liability or that is contrary to any Loan Document or applicable Law, including

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any action that may be in violation of the automatic stay under any Insolvency Proceeding; and

(iii) will not, except as expressly set forth herein and in the other Loan Documents, have any duty to disclose, and will not be liable for the failure to disclose, any information relating to the Obligors or any of its Subsidiaries or Affiliates that is communicated to or obtained by the Person serving as the Administrative Agent or any of its Affiliates in any capacity.

(b) The Administrative Agent will not be liable for any action taken or not taken by it (i) with the consent or at the request of the Majority Lenders (or such other number or percentage of the Lenders as will be necessary, or as the Administrative Agent believes in good faith will be necessary, under the circumstances), or (ii) in the absence of its own gross negligence or willful misconduct as determined by a court of competent jurisdiction by final and nonappealable judgment.  The Administrative Agent will be deemed not to have knowledge of any Default unless and until notice describing such Default is given to the Administrative Agent in writing by the Borrower or a Lender.

(c) The Administrative Agent will not be responsible for or have any duty to ascertain or inquire into (i) any statement, warranty or representation made in or in connection with this Agreement or any other Loan Document, (ii) the contents of any certificate, report or other document delivered hereunder or thereunder or in connection herewith or therewith, (iii) the performance or observance of any of the covenants, agreements or other terms or conditions set forth herein or therein or the occurrence of any Default, (iv) the validity, enforceability, effectiveness or genuineness of this Agreement, any other Loan Document or any other agreement, instrument or document or (v) the satisfaction of any condition set forth in Section 6 or elsewhere herein, other than to confirm receipt of items expressly required to be delivered to the Administrative Agent.

Section 13.04. Reliance by Administrative Agent

.  The Administrative Agent will be entitled to rely upon, and will not incur any liability for relying upon, any notice, request, certificate, consent, statement, instrument, document or other writing (including any electronic message, Internet or intranet website posting or other distribution) believed by it to be genuine and to have been signed, sent or otherwise authenticated by the proper Person.  The Administrative Agent also may rely upon any statement made to it orally or by telephone and believed by it to have been made by the proper Person, and will not incur any liability for relying thereon.  In determining compliance with any condition hereunder to the making of the Loans that by its terms must be fulfilled to the satisfaction of a Lender, the Administrative Agent may presume that such condition is satisfactory to such Lender unless the Administrative Agent has received notice to the contrary from such Lender prior to the making of such Loans.  The Administrative Agent may consult with legal counsel (who may be counsel for the Borrower), independent accountants and other experts selected by it, and will not be liable for any action taken or not taken by it in accordance with the advice of any such counsel, accountants or experts.

Section 13.05. Delegation of Duties

.  The Administrative Agent may perform any and all of its duties and exercise its rights and powers hereunder or under any other Loan Document by

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or through any one or more sub-agents appointed by the Administrative Agent.  The Administrative Agent and any such sub-agent may perform any and all of its duties and exercise its rights and powers by or through their respective Affiliates.  The exculpatory provisions of this Section will apply to any such sub-agent and to the Affiliates of the Administrative Agent and any such sub-agent, and will apply to their respective acti vities in connection with the syndication of the facility as well as activities as Administrative Agent.  The Administrative Agent will not be responsible for the negligence or misconduct of any sub-agents except to the extent that a court of competent jur isdiction determines in a final and nonappealable judgment that the Administrative Agent acted with gross negligence or willful misconduct in the selection of such sub-agents.

Section 13.06. Resignation of Agent

.  (a) The Administrative Agent may at any time give notice of its resignation to the Lenders and the Borrower, which notice shall set forth the effective date of such resignation (the “ Resignation Effective Date ”), such date not to be earlier than the thirtieth (30th) day following the date of such notice.  The Majority Lenders and the Borrower shall mutually agree upon a successor to the Administrative Agent.  If the Majority Lenders and the Borrower are unable to so mutually agree and no successor shall have been appointed within twenty-five (25) days after the retiring Administrative Agent gives notice of its resignation, then the retiring Administrative Agent may (but will not be obligated to), on behalf of the Lenders, appoint a successor Administrative Agent it shall designate (in its reasonable discretion after consultation with the Borrower and the Majority Lenders).  Whether or not a successor has been appointed, such resignation will become effective in accordance with such notice on the Resignation Effective Date.

(b) With effect from the Resignation Effective Date (i) the retiring Administrative Agent will be discharged from its duties and obligations hereunder and under the other Loan Documents (except that in the case of any Collateral held by the Administrative Agent on behalf of the Lenders under any of the Loan Documents, the retiring Administrative Agent will continue to hold such Collateral until such time as a successor Administrative Agent is appointed) and (ii) except for any indemnity payments owed to the retiring Administrative Agent, all payments, communications and determinations provided to be made by, to or through the Administrative Agent will instead be made by or to each Lender directly, until such time, if any, as the Majority Lenders appoint a successor Administrative Agent as provided for above.  Upon the acceptance of a successor’s appointment as Administrative Agent hereunder, such successor will succeed to and become vested with all of the rights, powers, privileges and duties of the retiring Administrative Agent (other than any rights to indemnity payments owed to the retiring Administrative Agent), and the retiring Administrative Agent will be discharged from all of its duties and obligations hereunder or under the other Loan Documents.  The fees payable by the Borrower to a successor Administrative Agent will be the same as those payable to its predecessor unless otherwise agreed between the Borrower and such successor.  After the retiring Administrative Agent’s resignation hereunder and under the other Loan Documents, the provisions of this Section 13 and Sections 14.03 and 14.04 will continue in effect for the benefit of such retiring Administrative Agent, its sub-agents and their respective Affiliates in respect of any actions taken or omitted to be taken by any of them while the retiring Administrative Agent was acting as Administrative Agent.

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Section 13.07. Non-Reliance on Administrative Agent and Other Lenders

.  Each Lender acknowledges that it has, independently and without reliance upon the Administrative Agent or any other Lender or any of their Affiliates and based on such documents and information as it has deemed appropriate, made its own credit analysis and decision to enter into this Agreement.  Each Lender also acknowledges that it will, independently and without reliance upon the Administrative Agent or any other Lender or any of their Affiliates and based on such documents and information as it will from time to time deem appropriate, continue to make its own decisions in taking or not taking action under or based upon this Agreement, any other Loan Document or any related agreement or any document furnished hereunder or thereunder.

Section 13.08. Administrative Agent May File Proofs of Claim

.  In case of the pendency of any Insolvency Proceeding or any other judicial proceeding relative to the Borrower, the Administrative Agent (irrespective of whether the principal of the Loans will then be due and payable as herein expressed or by declaration or otherwise and irrespective of whether the Administrative Agent has made any demand on the Borrower) will be entitled and empowered (but not obligated), by intervention in such proceeding or otherwise:

(a) to file and prove a claim for the whole amount of the principal and interest owing and unpaid in respect of the Loans and all other Obligations that are owing and unpaid hereunder or under any other Loan Document and to file such other documents as may be necessary or advisable in order to have the claims of the Lenders and the Administrative Agent (including any claim for the reasonable compensation, expenses, disbursements and advances of the Lenders and the Administrative Agent and their respective agents and counsel and all other amounts due the Lenders and the Administrative Agent under this Agreement or any other Loan Document) allowed in such judicial proceeding; and

(b) to collect and receive any monies or other property payable or deliverable on any such claims and to distribute the same.

Any custodian, receiver, assignee, trustee, liquidator, sequestrator or other similar official in any such judicial proceeding is hereby authorized by each Lender to make any payments of the type described above in this Section 13.08 to the Administrative Agent and, in the event that the Administrative Agent consents to the making of such payments directly to the Lenders, to pay to the Administrative Agent any amount due for the reasonable compensation, expenses, disbursements and advances of the Administrative Agent and its agents and counsel, and any other amounts due the Administrative Agent under this Agreement or any other Loan Document.

Section 13.09. Collateral and Guaranty Matters; Appointment of Collateral Agent

.  (a) Without limiting the provisions of Section 13.08, the Lenders irrevocably agree as follows:

(i) the Administrative Agent is authorized, at its option and in its discretion, to release any Lien on any property granted to or held by the Administrative Agent under any Loan Document (A) on the date when all Obligations have been satisfied in full in cash (other than Warrant Obligations and contingent obligations as to which no claims have been asserted), (B) that is sold or otherwise disposed of or to be sold or otherwise disposed of as part of or in connection with any sale or other disposition permitted under

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the Loan Documents, or (C) subject to Sections 14.01 and 14.04, if approved, authorized or ratified in writing by the Majority Lenders; and

(ii) the Administrative Agent is authorized, at its option and discretion, to release any Subsidiary Guarantor from its obligations hereunder if such Person ceases to be a Subsidiary as a result of a transaction permitted under the Loan Documents.

Upon request by the Administrative Agent at any time, each Lender will confirm in writing the Administrative Agent’s authority to release or subordinate its interest in particular types or items of Collateral, or to release any Guarantor from its obligations under its guaranty pursuant to this Section 13.09.

(b) The Administrative Agent will not be responsible for or have a duty to ascertain or inquire into any representation or warranty regarding the existence, value or collectability of the Collateral, the existence, priority or perfection of the Administrative Agent’s Lien thereon, or any certificate prepared by any Obligor in connection therewith, nor will the Administrative Agent be responsible or liable to the Lenders for any failure to monitor or maintain any portion of the Collateral.

(c) Each Lender hereby appoints the Administrative Agent as its collateral agent under each of the Security Documents and agrees that, in so acting, the Administrative Agent will have all of the rights, protections, exculpations, indemnities and other benefits provided to the Administrative Agent under this Agreement, and hereby authorizes and directs the Administrative Agent, on behalf of such Lender and all Lenders, without the necessity of any notice to or further consent from any of the Lenders, from time to time to (i) take any action with respect to any Collateral or any Security Document which may be necessary to perfect and maintain perfected the Liens on the Collateral granted pursuant to any such Security Document or protect and preserve the Administrative Agent’s ability to enforce the Liens or realize upon the Collateral, (ii) act as collateral agent for each Secured Party for purposes of acquiring, holding, enforcing and perfecting all Liens created by the Loan Documents and all other purposes stated therein, (iii) enter into intercreditor or subordination agreements, as the case may be, in connection with Indebtedness permitted pursuant to Section 9.01(n), (iv) enter into non-disturbance or similar agreements in connection with licensing agreements and arrangements permitted by this Agreement and the other Loan Documents and (v) otherwise to take or refrain from taking any and all action that the Administrative Agent shall deem necessary or advisable in fulfilling its role as collateral agent under any of the Security Documents.

Section 13.10. Swedish Pledge Agreement

.  Notwithstanding the terms of the Swedish Pledge Agreement, the Administrative Agent agrees to consent to any action sought to be taken by CareDx International AB to the extent such action is not prohibited pursuant to the terms of this Agreement.

SECTION 14.

Miscellaneous.

Section 14.01. No Waiver

.  No failure on the part of the Administrative Agent or the Lenders to exercise and no delay in exercising, and no course of dealing with respect to, any right, power or privilege under any Loan Document shall operate as a waiver thereof, nor shall

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any single or partial exercise of any right, power or privilege under any Loan Document preclude any other or further exercise thereof or the exercise of any other right, power or privilege.  The remedies provided herein are cumulative and not exclusive of any remedies provided by law.

Section 14.02. Notices

.  All notices, requests, instructions, directions and other communications provided for herein (including any modifications of, or waivers, requests or consents under, this Agreement) shall be given or made in writing (including by telecopy or email) delivered, if to the Borrower, another Obligor, the Administrative Agent or any Lender, to its address specified on the signature pages hereto or its Guarantee Assumption Agreement, as the case may be, or at such other address as shall be designated by such party in a written notice to the other parties.  Except as otherwise provided in this Agreement, all such communications shall be deemed to have been duly given upon receipt of a legible copy thereof, in each case given or addressed as aforesaid.  All such communications provided for herein by telecopy shall be confirmed in writing promptly after the delivery of such communication (it being understood that non-receipt of written confirmation of such communication shall not invalidate such communication).

Section 14.03. Expenses, Indemnification, Etc.

(a) Closing Expenses .  The Borrower agrees to pay or reimburse the Administrative Agent and the Lenders for all of their reasonable and documented out of pocket costs and expenses (including the reasonable and documented fees and expenses of Chapman and Cutler LLP, special counsel to the Administrative Agent) in connection with the negotiation, preparation, execution and delivery of this Agreement and the other Loan Documents and the making of the Loans.

(b) Other Expenses .  The Borrower agrees to pay or reimburse (i) the Administrative Agent and the Lenders for all of their reasonable and documented out of pocket post-closing costs and expenses in connection the negotiation or preparation of any modification, supplement or waiver of any of the terms of this Agreement or any of the other Loan Documents (whether or not consummated) and (ii) the Administrative Agent and the Lenders for all of their out of pocket costs and expenses (including the fees and expenses of legal counsel) in connection with any enforcement or collection proceedings resulting from the occurrence of an Event of Default.

(c) Indemnification .  The Borrower hereby indemnifies the Administrative Agent, the Lenders and their respective Affiliates, directors, officers, employees, attorneys, agents, advisors and controlling parties (each, an “ Indemnified Party ”) from and against, and agrees to hold them harmless against, any and all Claims and Losses of any kind (including reasonable and documented fees and disbursements of counsel), joint or several, that may be incurred by or asserted or awarded against any Indemnified Party, in each case arising out of or in connection with or relating to any investigation, litigation or proceeding or the preparation of any defense with respect thereto arising out of or in connection with or relating to this Agreement or any of the other Loan Documents or the Transactions or any use made or proposed to be made with the proceeds of the Loans, whether or not such investigation, litigation or proceeding is brought by the Borrower, any of its shareholders or creditors, an Indemnified Party or any other Person, or an Indemnified Party is otherwise a party thereto, and whether or not any of the conditions precedent set forth in Section 6 are satisfied or the other transactions contemplated by this

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A greement are consummated, except to the extent such Claim or Loss is found in a final, non-appealable judgment by a court of competent jurisdiction to have resulted from such Indemnified Party’s gross negligence or willful misconduct.  No Obligor shall ass ert any claim against any Indemnified Party, on any theory of liability, for consequential, indirect, special or punitive damages arising out of or otherwise relating to this Agreement or any of the other Loan Documents or any of the Transactions or the ac tual or proposed use of the proceeds of the Loans.  No Lender shall assert any claim against the Borrower or any of its Subsidiaries or any of their respective directors, officers, employees, attorneys, agents, advisors or controlling parties (collectively , the “ Borrower Parties ”) on any theory of liability, for consequential, indirect, special or punitive damages arising out of or otherwise relating to this Agreement or any of the other Loan Documents or any of the transactions contemplated hereby or there by or the actual or proposed use of the proceeds of the Loans.  This Section 14.03(c) shall not apply with respect to Taxes other than any Taxes that represent Claims and Losses arising from any non-Tax claim.

Section 14.04. Amendments, Etc

.  Except as otherwise expressly provided in this Agreement, any provision of this Agreement and any other Loan Document may be modified or supplemented only by an instrument in writing signed by the Borrower, the Administrative Agent and the Majority Lenders; provided that:

(a) any such modification or supplement that is disproportionately adverse to any Lender as compared to other Lenders or subjects any Lender to any additional obligation shall not be effective without the consent of such affected Lender;

(b) the consent of all of the Lenders shall be required to:

(i) amend, modify, discharge, terminate or waive any of the terms of this Agreement or any other Loan Agreement if such amendment, modification, discharge, termination or waiver would increase the amount of the Loans, reduce the fees payable hereunder, reduce interest rates or other amounts pay able with respect to the Loans, extend any date fixed for payment of principal, interest or other amounts payable relating to the Loans or extend the repayment dates of the Loans;

(ii) amend, modify, discharge, terminate or waive any Security Document if the effect is to release a material part of the Collateral subject thereto other than pursuant to the terms hereof or thereof; or

(iii) amend this Section 14.04.

Section 14.05. Successors and Assigns.

(a) General .  This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and assigns permitted hereby; provided that the neither the Borrower nor any other Obligor may assign or transfer its rights or obligations hereunder without the prior written consent of the Administrative Agent.  No Lender may assign or otherwise transfer any of its rights or obligations hereunder or under any of the other Loan Documents except (i) to an assignee in accordance with the provisions of Section 14.05(b), or (ii) by way of participation in accordance with the provisions of Section 14.05(e) (and any other

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attempted assignment or transfer by any party hereto shall be null and void).  Nothing in this Agreement, expressed or i mplied, shall be construed to confer upon any Person (other than the parties hereto, their respective successors and assigns permitted hereby, Participants to the extent provided in Section 14.05(e) and, to the extent expressly contemplated hereby, the Ind emnified Parties) any legal or equitable right, remedy or claim under or by reason of this Agreement.

(b) Assignments by Lender .  Any of the Lenders may at any time assign to one or more Eligible Transferees (or, if an Event of Default has occurred and is continuing, to any Person) all or a portion of its rights and obligations under this Agreement (including all or a portion of the Commitment and the Loans at the time owing to it) and the other Loan Documents; provided that no such assignment shall be made to the Borrower, any Affiliate of the Borrower or any employees or directors of any Obligor at any time.  Subject to the recording thereof by the Administrative Agent pursuant to Section 14.05(d), from and after the effective date specified in each Assignment and Assumption, the assignee thereunder shall be a party to this Agreement and, to the extent of the interest assigned by such Assignment and Assumption, have the rights and obligations of such Lender under this Agreement and the other Loan Documents, and correspondingly the assigning Lender shall, to the extent of the interest assigned by such Assignment and Assumption, be released from its obligations under this Agreement (and, in the case of an Assignment and Assumption covering all of the Lender’s rights and obligations under this Agreement, such Lender shall cease to be a party hereto) and the other Loan Documents but shall continue to be entitled to the benefits of Section 5 and Section 14.03.  Any assignment or transfer by a Lender of rights or obligations under this Agreement that does not comply with this Section 14.05(b) shall be treated for purposes of this Agreement as a sale by such Lender of a participation in such rights and obligations in accordance with Section 14.05(e).

(c) [ Reserved ].

(d) Register .  The Administrative Agent shall maintain a copy of each Assignment and Assumption delivered to it pursuant to clause (b) above and a register for the recordation of the names and addresses of the Lenders, and the Commitments of, and principal amounts (and stated interest) of the Loans owing to, each Lender pursuant to the terms hereof from time to time (the “ Register ”).  The entries in the Register shall be conclusive absent manifest error, and the Borrower, the Administrative Agent and the Lenders shall treat each Person whose name is recorded in the Register pursuant to the terms hereof as a Lender hereunder for all purposes of this Agreement.  The Register shall be available for inspection by the Borrower and any Lender, at any reasonable time and from time to time upon reasonable prior notice.  The Obligations under the Loan Documents (other than the Warrant Obligations) are intended to be maintained in, and this Section shall be construed so that the Commitments and Loans are at all times maintained in, “registered form” within the meaning of Section 163(f), 871(h)(2) and 881(c)(2) of the Code and any related regulations (and any other relevant or successor provisions of the Code or such regulations).

(e) Participations .  Any of the Lenders may at any time, without the consent of, or notice to, the Borrower, sell participations to any Person which would constitute an Eligible Transferee (other than a natural person or a holding company, investment vehicle or trust for, or owned and operated for the primary benefit of, a natural person or the Borrower or any of the Borrower’s Affiliates or Subsidiaries) (each, a “ Participant ”) in all or a portion of such Lender’s

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rights and/or obligations under this Agreement (including all or a portion of the Commitment and/o r the Loans owing to it); provided that (i) such Lender’s obligations under this Agreement shall remain unchanged, (ii) such Lender shall remain solely responsible to the other parties hereto for the performance of such obligations and (iii) the Borrower s hall continue to deal solely and directly with such Lender in connection therewith.  Any agreement or instrument pursuant to which a Lender sells such a participation shall provide that such Lender shall retain the sole right to enforce this Agreement and to approve any amendment, modification or waiver of any provision of this Agreement; provided that such agreement or instrument may provide that such Lender will not, without the consent of the Participant, agree to any amendment, modification or waiver th at would (i) increase or extend the term of such Lender’s Commitment, (ii) extend the date fixed for the payment of principal of or interest on the Loans or any portion of any fee hereunder payable to the Participant, (iii) reduce the amount of any such pa yment of principal, or (iv) reduce the rate at which interest is payable thereon to a level below the rate at which the Participant is entitled to receive such interest (other than with respect to default interest).  The Borrower agrees that each Participa nt shall be entitled to the benefits of Section 5 (subject to the requirements and limitations therein, including the requirements of Section 5.03(f) (it being understood that the documentation required under Section 5.03(f) shall be delivered to the parti cipating Lender)) to the same extent as if such Participant had acquired its interest by assignment pursuant to Section 14.05(b); provided that such Participant shall not be entitled to receive any greater payment under Section 5 with respect to any partic ipation, than its participating Lender would have been entitled to receive.  To the extent permitted by Law, each Participant also shall be entitled to the benefits of Section 4.03(a) as though it were a Lender.  Each Lender that sells a participation shal l, acting solely for this purpose as a non-fiduciary agent of the Borrower, maintain a register on which it enters the name and address of each Participant and the principal amounts (and stated interest) of each Participant’s interest in the Loans or other obligations under the Loan Documents (the “ Participant Register ”); provided that no Lender shall have any obligation to disclose all or any portion of the Participant Register (including the identity of any Participant or any information relating to a Par ticipant’s interest in any commitments, loans, letters of credit or its other obligations under any Loan Document) to any Person except to the extent that such disclosure is necessary to establish that such commitment, loan, letter of credit or other oblig ation is in registered form under Section 5f.103-1(c) of the United States Treasury Regulations.  The entries in the Participant Register shall be conclusive absent manifest error, and the parties hereto shall treat each Person whose name is recorded in th e Participant Register as the owner of such participation for all purposes of this Agreement notwithstanding any notice to the contrary.

(f) Security Interest .  Notwithstanding anything to the contrary contained in this Section 14.05, a Lender may collaterally assign any of its rights or obligations hereunder or under any of the other Loan Documents by way of pledge or collateral assignment of all or a portion of such Lender’s rights under the Loan Documents to a Federal Reserve Bank provided that no such pledge or assignment shall release such Lender from its obligations hereunder.

Section 14.06. Survival

.  The obligations of the Borrower under Sections 5.01, 5.02, 5.03, 14.05 and the obligations of the Subsidiary Guarantors under Section 12 (solely to the extent guaranteeing any of the obligations under the foregoing Sections) shall survive the repayment of the Obligations and the termination of the Commitment and, in the case of the Lenders’ assignment of any interest in the Commitment or the Loans hereunder, shall survive, in the case

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of any event or circumstance that occurred prior to the effective date of such assignment, the making of such assignment, notwithstanding that the Lenders may cease to be “Lenders” hereunder.  In addition, each representation and warranty made , or deemed to be made by a Borrowing Notice, herein or pursuant hereto shall survive the making of such representation and warranty.

Section 14.07. Captions

.  The table of contents and captions and section headings appearing herein are included solely for convenience of reference and are not intended to affect the interpretation of any provision of this Agreement.

Section 14.08. Counterparts

.  This Agreement may be executed in any number of counterparts, all of which taken together shall constitute one and the same instrument and any of the parties hereto may execute this Agreement by signing any such counterpart.  Delivery of an executed signature page of this Agreement by facsimile transmission or electronic transmission (in PDF format) shall be effective as delivery of a manually executed counterpart hereof.

Section 14.09. Governing Law

.  This Agreement and the rights and obligations of the parties hereunder shall be governed by, and construed in accordance with, the law of the State of New York, without regard to principles of conflicts of laws that would result in the application of the laws of any other jurisdiction; provided that Section 5-1401 of the New York General Obligations Law shall apply.

Section 14.10. Jurisdiction, Service of Process and Venue.

(a) Submission to Jurisdiction .  Each Obligor agrees that any suit, action or proceeding with respect to this Agreement or any other Loan Document to which it is a party or any judgment entered by any court in respect thereof may be brought initially in the federal or state courts in New York, New York or in the courts of its own corporate domicile and irrevocably submits to the exclusive jurisdiction of each such court for the purpose of any such suit, action, proceeding or judgment.  This Section 14.10(a) is for the benefit of the Administrative Agent and the Lenders only and, as a result, neither the Administrative Agent nor any Lender shall be prevented from taking proceedings in any other courts with jurisdiction.  To the extent allowed by any Law, the Administrative Agent and the Lenders may take concurrent proceedings in any number of jurisdictions.

(b) Alternative Process .  Nothing herein shall in any way be deemed to limit the ability of the Lenders to serve any process or summons in any manner permitted by Law.

(c) Waiver of Venue, Etc .  Each Obligor irrevocably waives to the fullest extent permitted by law any objection that it may now or hereafter have to the laying of the venue of any suit, action or proceeding arising out of or relating to this Agreement or any other Loan Document and hereby further irrevocably waives to the fullest extent permitted by law any claim that any such suit, action or proceeding brought in any such court has been brought in an inconvenient forum.  A final judgment (in respect of which time for all appeals has elapsed) in any such suit, action or proceeding shall be conclusive and may be enforced in any court to the jurisdiction of which such Obligor is or may be subject, by suit upon judgment.

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Section 14.11. Waiver of Jury Trial

.   Each Obligor, the Administrative Agent and each Lender hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any suit, action or proceeding arising out of or relating to this Agreement, the other Loan Documents or the transactions contemplated hereby or thereby .

Section 14.12. [Reserved].

Section 14.13. Entire Agreement

.  This Agreement and the other Loan Documents constitute the entire agreement among the parties with respect to the subject matter hereof and thereof and supersede any and all previous agreements and understandings, oral or written, relating to the subject matter hereof, including any confidentiality (or similar) agreements.   Each Obligor acknowledges, represents and warrants that in deciding to enter into this Agreement and the other Loan Documents or in taking or not taking any action hereunder or thereunder, it has not relied, and will not rely, on any statement, representation, warranty, covenant, agreement or understanding, whether written or oral, of or with the Lenders other than those expressly set forth in this Agreement and the other Loan Documents.

Section 14.14. Severability

.  If any provision hereof is found by a court to be invalid or unenforceable, to the fullest extent permitted by any applicable Law the parties agree that such invalidity or unenforceability shall not impair the validity or enforceability of any other provision hereof.

Section 14.15. No Fiduciary Relationship

.  The Borrower acknowledges that the Administrative Agent and the Lenders have no fiduciary relationship with, or fiduciary duty to, the Borrower arising out of or in connection with this Agreement or the other Loan Documents, and the relationship between the Lenders and the Borrower is solely that of creditor and debtor.  This Agreement and the other Loan Documents do not create a joint venture among the parties.

Section 14.16. Confidentiality

.  Each Lender agrees to keep confidential all non-public information provided to it by any Obligor pursuant to this Agreement; provided that nothing herein shall prevent any Lender from disclosing any such information (i) to any other Lender or, subject to a written agreement to comply with the provisions of this Section 14.16, any Affiliate of a Lender or any prospective assignee of Loans permitted by and pursuant to Section 14.05(b) that, in each case, is also subject to confidentiality provisions at least as stringent as the provisions of this Section 14.16, (ii) subject to an agreement to comply with the provisions of this Section, to any actual or prospective direct or indirect counterparty to any Hedging Agreement (or any professional advisor to such counterparty), (iii) to its employees, officers, directors, agents, attorneys, accountants, trustees and other professional advisors (collectively, its “ Related Parties ”); provided that the applicable Lender shall remain liable hereunder for any breach of this Section 14.16 by any of its Related Parties, (iv) upon the request or demand of any Governmental Authority or any Regulatory Authority having jurisdiction over such Person or its Related Parties (including any self-regulatory authority, such as the National Association of Insurance Commissioners), (v) in response to any order of any court or other Governmental Authority or as may otherwise be required pursuant to any applicable Law, (vi) if required to do so in connection with any litigation or similar proceeding, (vii) that has been publicly disclosed

--


 

(other than as a result of a disclosure in violation of this Section 14.16), (viii) on a confidential basis to the National Association of Insurance Commissioners or any similar organization or any nationally recognized rating agency that requires access to information about a Lender’s investment portfolio in connection with ratings issued with respect to such Lender, (ix) in connection with the exercise of any remedy permitted hereunder or unde r any other Loan Document, (x) on a confidential basis to (A) any rating agency in connection with rating the Borrower or its Subsidiaries or the Loan or (B) the CUSIP Service Bureau or any similar agency in connection with the issuance and monitoring of C USIP numbers of other market identifiers with respect to the Loan or (xi) to any other party that is, and is permitted pursuant to the terms hereof to be, a party hereto; provided further that, unless specifically prohibited by applicable law or court orde r, each Lender shall notify the Borrower of any request by any Governmental Authority or Regulatory Authority or representative thereof (other than any such request in connection with any examination of the financial condition or other routine examination of such Lender by such Governmental Authority or Regulatory Authority) for disclosure of any such non-public information prior to disclosure of such information to enable the Borrower to seek a protection order or otherwise prevent or restrict such disclos ure.

Section 14.17. Right of Setoff

.  If an Event of Default shall have occurred and be continuing, each Lender and each of its Affiliates is hereby authorized at any time and from time to time, to the fullest extent permitted by applicable Law, to set off and apply any and all deposits (general or special, time or demand, provisional or final, in whatever currency) at any time held and other obligations (in whatever currency) at any time owing by such Lender or any such Affiliate to or for the credit or the account of the Borrower or any other Obligor against any and all of the Obligations now or hereafter existing under this Agreement or any other Loan Document to such Lender or its Affiliates, irrespective of whether or not such Lender or Affiliate shall have made any demand under this Agreement or any other Loan Document and although such Obligations of the Borrower or such Obligor may be contingent or unmatured or are owed to an Affiliate of such Lender.  The rights of each Lender and its Affiliates under this Section are in addition to other rights and remedies (including other rights of setoff) that such Lender and Affiliates may have.  Each Lender agrees to notify the Borrower promptly after any such setoff and application; provided that the failure to give such notice shall not affect the validity of such setoff and application.

Section 14.18. Judgment Currency

.  (a) If, for the purposes of obtaining judgment in any court, it is necessary to convert a sum due hereunder in Dollars into another currency, the parties hereto agree, to the fullest extent permitted by Law, that the rate of exchange used shall be that at which, in accordance with normal banking procedures, the Administrative Agent could purchase Dollars with such other currency at the buying spot rate of exchange in the New York foreign exchange market on the Business Day immediately preceding that on which any such judgment, or any relevant part thereof, is given.

(b) The obligations of the Obligors in respect of any sum due to the Administrative Agent hereunder and under the other Loan Documents shall, notwithstanding any judgment in a currency other than Dollars, be discharged only to the extent that on the Business Day following receipt by the Administrative Agent of any sum adjudged to be so due in such other currency the Administrative Agent may, in accordance with normal banking procedures, purchase Dollars with such other currency.  If the amount of Dollars so purchased is less than the sum originally

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due to the Administrative Agent in Dollars, the Borrower agrees, to the fullest extent that it may effectively do so, as a separate obligation and notwithstanding any such judgment, to indemnify the Administrative Agent against such loss.  If the amount of Dollars so purchased exceeds the sum originally due to the Administrative Agent in Dollars, the Administrative Agent shall remit such excess to the Borrower.

Section 14.19. USA PATRIOT Act

.  The Administrative Agent and the Lenders hereby notify the Obligors that pursuant to the requirements of the USA PATRIOT Act (Title III of Pub. L. 107-56 (signed into law October 26, 2001)) (the “ Act ”), they are required to obtain, verify and record information that identifies the Obligors, which information includes the name and address of each Obligor and other information that will allow such Person to identify such Obligor in accordance with the Act.

Section 14.20. Release of Collateral and Guarantees; Non-Disturbance Agreements

.  (a) The Administrative Agent hereby agrees, at the sole expense of the Borrower, to execute any documents, releases, terminations and agreements reasonably requested by the Borrower (i) to release any Lien on any Collateral (A) on the date when all Obligations (other than Warrant Obligations and contingent obligations as to which no claims have been asserted) have been satisfied in full in cash, (B) that is sold or otherwise disposed of or to be sold or otherwise disposed of as part of or in connection with an Asset Sale permitted pursuant to Section 9.09 or (C) subject to Sections 14.01 and 14.04, if approved, authorized or ratified in writing by the Administrative Agent and (ii) to release any Subsidiary Guarantor from its obligations as a guarantor hereunder if such Person ceases to be a Subsidiary as a result a transaction permitted under the Loan Documents.

(b) The Administrative Agent hereby agrees to, and each Lender hereby agrees that Administrative Agent may, enter into non-disturbance or similar agreements in connection with licensing agreements permitted by this Agreement or any other Loan Document, in each case in form and substance reasonably satisfactory to the Administrative Agent and the counterparty or counterparties to the licensing agreements.

Section 14.21. Acknowledgement and Consent to Bail-In of EEA Financial Institutions

.  Notwithstanding anything to the contrary in any Loan Document or in any other agreement, arrangement or understanding among any such parties, each party hereto acknowledges that any liability of any EEA Financial Institution arising under any Loan Document, to the extent such liability is unsecured, may be subject to the write-down and conversion powers of an EEA Resolution Authority and agrees and consents to, and acknowledges and agrees to be bound by:

(a) the application of any Write-Down and Conversion Powers by an EEA Resolution Authority to any such liabilities arising hereunder which may be payable to it by any party hereto that is an EEA Financial Institution; and

(b) the effects of any Bail-In Action on any such liability, including, if applicable:

(i) a reduction in full or in part or cancellation of any such liability;

- -


 

(ii) a conversion of all, or a portion of, such liability into shares or other instruments of ownership in such EEA Financial Institution, its parent undertaking, or a bridge institution that may be issued to it or otherwise conferred on it, and that such shares or other instruments of ownership will be accepted by it in lieu of any rights with respect to any such liability under this Agreement or any other Loan Document; or

(iii) the variation of the terms of such liability in connection with the exercise of the write-down and conversion powers of any EEA Resolution Authority.

[Signature Pages Follow]

 

- -


 

In Witness Whereof , the parties hereto have caused this Agreement to be duly executed and delivered as of the d ay and year first above written.

Borrower :

CareDx, Inc .

 

By:

/s/ Michael Bell
Name:       Michael Bell                      
Title:      Chief Financial Officer         

Address for Notices:

3260 Bayshore Boulevard
Brisbane, CA 94005
Attn:  Dr. Peter Maag
Email:  pmaag@caredx.com

 

[Signature Page to Credit Agreement and Guaranty]


 

Administrative Agent :

Perceptive Credit Holdings II, LP

 

By:

Perceptive Credit Opportunities GP, LLC,
its general partner

 

By:

/s/ Sandeep Dixit
Name: Sandeep Dixit                         
Title: Chief Credit Officer                

 

By:

/s/ Sandeep Dixit
Name: Sandeep Dixit                          
Title: Portfolio Manager                   

Address for Notices:

Perceptive Credit Holdings II, LP
c/o Perceptive Advisors LLC
51 Astor Place, 10th Floor
New York, NY 10003
Attn:  Sandeep Dixit
Email:  Sandeep@perceptivelife.com

 

[Signature Page to Credit Agreement and Guaranty]


 

Lenders:

Perceptive Credit Holdings II, LP

 

By:

Perceptive Credit Opportunities GP, LLC,
its general partner

 

By:

/s/ Sandeep Dixit
Name: Sandeep Dixit                         
Title: Chief Credit Officer                

 

By:

/s/ Sandeep Dixit
Name: Sandeep Dixit                          
Title: Portfolio Manager                   

Address for Notices:

Perceptive Credit Holdings II, LP
c/o Perceptive Advisors LLC
51 Astor Place, 10th Floor
New York, NY 10003
Attn:  Sandeep Dixit
Email:  Sandeep@perceptivelife.com

 

 

[Signature Page to Credit Agreement and Guaranty]


 

SCHEDULE 1
CO
MMITMENTS AND WARRANT SHARES


Tranche A Term Loan Commitments

Lender

Commitment

Perceptive Credit Holdings II, LP

$25,000,000

 



Tranche B Term Loan Commitments

Lender

Commitment

Perceptive Credit Holdings II, LP

$10,000,000

 



Warrant Shares

Tranche A Warrant:

Lender

Warrant Shares

Perceptive Credit Holdings II, LP

140,000

 



Tranche B Warrant:

Lender

Warrant Shares

Perceptive Credit Holdings II, LP

93,333

 

 

 

 

Exhibit 10.3
*** Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4)

LICENSE AND COMMERCIALIZATION AGREEMENT

 

This License and Commercialization Agreement (“ Agreement ”) is effective as of the date of last signature below (the “ Effective Date ”) by and between Illumina, Inc., a Delaware corporation, having a place of business at 5200 Illumina Way, San Diego, CA, 92122 (“ Illumina ”), and CareDx, Inc., a Delaware corporation, having a place of business at 3260 Bayshore Boulevard, Brisbane, CA 94005 (“ CareDx ”).  Illumina and CareDx may each be referred to in this Agreement individually as a “ Party ” and collectively as the “ Parties .”

 

RECITALS

 

A. CareDx is a business focused on developing, manufacturing, and selling products in the Licensed Field (defined below);

 

B. Illumina owns or otherwise Controls (defined below) rights to certain Intellectual Property (defined below), including patents, patent applications, and know-how, relating to products in the Licensed Field;

 

C. Illumina also has existing products that it manufactures and sells (including through distributors), and products that are in development, for use in the Licensed Field;

 

D. CareDx desires to (i) obtain a field-based license to certain Intellectual Property for making, using, and selling products for use in the Licensed Field with Illumina’s sequencing platforms, (ii) purchase certain products from Illumina for resale, and (iii) obtain a transfer of technology from Illumina relating to the manufacture of certain products in development; and

 

E. Illumina is willing to grant such a license, sell such products, and conduct such a technology transfer to CareDx on the terms and subject to the conditions set forth in this Agreement.

 

NOW, THEREFORE, in consideration of the mutual covenants contained in this Agreement, the foregoing recitals and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

1. DEFINITIONS  

 

The following capitalized terms have the following meanings:

 

1.1 Ad/Promo Guidelines ” means Illumina’s current guidelines for advertising and promotional materials, which will be commercially reasonable at all times.

 

1.2 Affiliate ” means, with respect to a Party or other party, any Person which at the time in question directly or indirectly Controls, is Controlled by, or is under common Control with, such Party or other party.  For the purposes of this definition only, “ Control ” means the possession, directly or indirectly, of: (i) more than 50% of the voting interests of a Person; or (ii) the power to direct or cause the direction of the management or policies of a Person, whether through the ownership of voting interests, by agreement with respect to the voting of voting interests, by other agreement conferring control over management or policy decisions, by virtue of the power to control the composition of the

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board of directors or managers, or otherwise.  The terms “ Controlling ” and “ Controlled ” have correlative meanings for purposes of this definition.   Not withstanding the foregoing, Helix Holdings I, LLC, and its subsidiaries and members, are not Affiliates of Illumina for purposes of this Agreement.

 

1.3 Anti-Corruption Laws ” has the meaning set forth in Exhibit C .

 

1.4 Approval(s) ” has the meaning set forth in Exhibit C , Section 3.

 

1.5 CareDx Existing Products ” has the meaning set forth in Section 4.1.

 

1.6 CareDx Marks ” has the meaning set forth in Section 5.8(b).

 

1.7 Changed Component(s) ” has the meaning set forth in Section 5.7.

 

1.8 Chimerism Assay ” means the [...***...] of each of [...***...] in a [...***...].

 

1.9 Chimerism Royalty Product ” means a Licensed Product that is used for a Chimerism Assay application.

 

1.10 Claim(s) ” has the meaning set forth in Section 12.1.

 

1.11 Combination Product ” means any combination of the Licensed Product and another product that is not the Licensed Product, where such products are not formulated together but are sold together as a single product.

 

1.12 Complaint(s) ” has the meaning set forth in Exhibit C .

 

1.13 Complete Change ” has the meaning set forth in Section 5.7.

 

1.14 Confidential Information ” means all information that (i) is provided by one Party (or its Affiliates) to the other Party (or its Affiliates) pursuant to this Agreement, and (ii) (A) if disclosed in writing or other tangible medium is marked or identified as confidential at the time of disclosure to the recipient, (B) if disclosed other than in writing, is acknowledged at the time of disclosure to be confidential and is documented as confidential by written notice to the recipient within 30 days after disclosure, or (C) that a recipient should reasonably understand to be confidential.  Confidential Information shall not include any of the following: (a) information that, at the time of disclosure to the Receiving Party, is in the public domain through no breach of this Agreement or breach of another obligation of confidentiality owed to the Disclosing Party or its Affiliates by the Receiving Party; (b) information that, after disclosure hereunder, becomes part of the public domain by publication or otherwise, except by breach of this Agreement or breach of another obligation of confidentiality owed to the Disclosing Party or its Affiliate by the Receiving Party; (c) information that was in the Receiving Party’s or its Affiliate’s possession at the time of disclosure hereunder by the Disclosing Party unless subject to an obligation of confidentiality or restricted use owed to the Disclosing Party or its Affiliate; (d) information that is independently developed by or for the Receiving Party or its Affiliates without use of or reliance on Confidential Information of the Disclosing Party; or (e) information that the Receiving Party receives from a third party where such third party was under no obligation of confidentiality to the Disclosing Party or its Affiliate with respect to such information.

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1.15 Contract Year ” means 12 calendar months from June 1, 2018 , and every anniversary thereof.

 

1.16 Control,” “Controls,” “Controlled,” or “Controlling” means, with respect to any Intellectual Property, possession of the right (whether through ownership or license (other than by operation of this Agreement) or control over an Affiliate with such right) to grant the licenses or sublicenses as provided herein without violating the terms of any agreement or other arrangement with any third party.

 

1.17 Customer Agreement ” has the meaning set forth in Exhibit C .

 

1.18 Disclosing Party ” has the meaning set forth in Section 10.1(a).

 

1.19 Discontinued Product ” has the meaning set forth in Section 5.7.

 

1.20 Documentation ” means Illumina’s user manual, package insert, and similar technical documentation, for the Supplied Product in effect on the date that the Supplied Product ships from Illumina.

 

1.21 Excluded Uses ” means (i) [...***...] (but for the avoidance of doubt, excluding bone marrow (hematopoietic stem cell) transplantation diagnostic testing), (ii) [...***...] applications, (iii) [...***...] for [...***...], [...***...], [...***...], [...***...], [...***...] and [...***...] or [...***...], (iv) [...***...], (v) [...***...], and (vi) use of [...***...] for [...***...].

 

1.22 Exclusive IP ” has the meaning set forth in Section 7.2.

 

1.23 Force Majeure ” has the meaning set forth in Section 14.8.

 

1.24 Illumina Chimerism Formulation ” means the formulations of the [...***...] that Illumina developed for and included in its [...***...] for Chimerism Assay applications as of the Effective Date in the Licensed Field.  The Illumina Chimerism Formulation excludes the Illumina Chimerism Primers.

 

1.25 Illumina Chimerism Primers ” means the [...***...] primer sequences and design parameters that Illumina developed for and included in its [...***...] for Chimerism Assay applications as of the Effective Date in the Licensed Field.  

 

1.26 Illumina Chimerism Software ” means the [...***...] software that Illumina developed for and included in its development-stage assay for Chimerism Assay applications as of the Effective Date in the Licensed Field.

 

1.27 Illumina HLA Existing Products ” means the Illumina HLA v1 Product and Illumina HLA v2 Product.

 

1.28 Illumina HLA Existing Product Primers ” means the [...***...] primers included as components of the Illumina HLA Existing Products.

 

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1.29 Illumina HLA Existing Product Software ” means version nos. 1.0, 2.0, and 2.1 of the software , referred to as “ TruSight HLA Assign,” that as of the Effective Date are licensed to pur chasers of the Illumina HLA Existing Products for use with Illumina HLA Existing Products including released and unreleased IMGT database software updates .

 

1.30 Illumina HLA v1 Product ” means the products bearing Illumina catalogue numbers FC-142-1001, 20006995, 20005171, and 20005172 as of the Effective Date.

 

1.31 Illumina HLA v2 Product ” means the products bearing Illumina catalogue numbers 20000215 and 20005170, as of the Effective Date.

 

1.32 Illumina HLA v3 [ ...***... ] ” means the [...***...] and [...***...] that Illumina is developing or had previously developed for, and as or was included in, its [...***...] (as the next version of the Illumina [...***...] Product) as of the Effective Date that includes the Illumina [...***...] Reagents and the Illumina HLA v3 Software.

 

1.33 Illumina HLA v3 Software ” means the [...***...] software for use with its [...***...] (as the next version of the Illumina [...***...] Product) as of the Effective Date that includes the Illumina [...***...] Reagents and the Illumina HLA v3 [...***...].

 

1.34 Illumina [ ...***... ] Reagents ” means the products listed in Exhibit B under the heading “Illumina [...***...] Reagent Pricing.”

 

1.35 Illumina Product Restriction ” has the meaning set forth in Section 4.2.

 

1.36 Illumina Sequencing Instrument ” means: (i) any instrument for [...***...] offered for sale in Illumina’s product catalogue up to and as of the Effective Date, excluding the [...***...], the [...***...], and the [...***...], and (ii) any improvement, update or upgrade to such instruments, whether such improvement, update or upgrade is incorporated into such instruments or installed or added to such instruments separately, provided that the instruments still have substantially the same functionality and throughput.

 

1.37 Illumina Software Code ” means the source code and executable code contained in the Illumina HLA Existing Product Software, Illumina HLA v3 Software, and Illumina Chimerism Software.

 

1.38 Improvement ” means any improvement, enhancement, or modification made by or on behalf of CareDx during the Term to technology or other subject matter that (i) is claimed by the Licensed Patents (pending or issued), (ii) constitutes a derivative work of a work subject to a Licensed Field Copyright, or (iii) constitutes a derivative work or is based on Licensed Know-How, and all Intellectual Property embodied therein, that has, in each of the foregoing cases, uses outside of the Licensed Field.  

 

1.39 Intellectual Property ” means all patents, patent rights, trademarks, service marks, trade names, trade dress, copyrights, works of authorship, Know-How and any other intellectual property or industrial property rights anywhere in the world.

 

 

 

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1.40 Know-How means any ideas, inventions, know-how, trade secrets, data, specifications, instructions, processes, formulas, and technology, including analytical and manufacturing data and information.

 

1.41 Knowledge Transfer ” has the meaning set forth in Section 8.1.

 

1.42 Lead Time ” means the maximum number of business days between the date CareDx issues a purchase order for the applicable Supplied Product and the date that such Supplied Product is delivered to the delivery location specified on such purchase order.

 

1.43 Licensed Field means (a) Chimerism Assay applications for the [ ...***... ] by [ ...***... ] of up to [ ...***... ] in a [ ...***... ] following and in association with bone marrow (hematopoietic stem cell) transplantation or solid organ transplantation or (b) [...***...] of the following [...***...] (or [...***...] only if expressly noted in this definition) of the [...***...] solely for bone marrow (hematopoietic stem cell) transplantation diagnostic testing and solid organ transplantation diagnostic testing (or only a specific application of such testing if expressly noted in this definition) of: (1) human leukocyte antigen (HLA); (2) [...***...]; (3) [...***...]; (4) the [...***...] listed in Exhibit H for use in [...***...] only; and (5) [...***...] in the [...***...] to [...***...] only up to [...***...] in such [...***...] and not for [...***...] level or [...***...] level [...***...] .  The Licensed Field excludes the Excluded Uses.

 

1.44 Licensed Field Copyrights ” means the copyrights owned or Controlled by Illumina and its Affiliates in the Illumina Software Code.

 

1.45 Licensed Field General Know-How ” means all Know-How owned or Controlled by Illumina or its Affiliates any time during the Term that is or was used for, but not specific only to, the development, manufacture, supply or commercialization of Licensed Products or the provision of Licensed Services (but only relating to use of a Licensed Product in the Licensed Service) in the Licensed Field.  Licensed Field General Know-How excludes Know-How relating to Third Party Knowledge Transfer Components.

 

1.46 Licensed Field General Patents ” means any patents and patent applications which are owned or Controlled by Illumina and its Affiliates at any time during the Term which in the absence of a license or sublicense granted by Illumina would be infringed (directly or indirectly) by the development, manufacture, marketing, use, development, Sale, offer for Sale, importation, exportation, commercialization, service, support or other exploitation of Licensed Products or the provision of Licensed Services.

 

1.47 Licensed Field Specific Know-How ” means all Know-How owned or Controlled by Illumina or its Affiliates any time during the Term that is or was used for and is specific only to the development, manufacture or commercialization of Licensed Products or the provision of Licensed Services (but only relating to the use of a Licensed Product in the Licensed Service) in the Licensed Field.  The Illumina HLA Existing Product Primers, Illumina HLA v3 [...***...], and Illumina Chimerism Primers are Licensed Field Specific Know-How.  Licensed Field Specific Know-How excludes Know-How relating to Third Party Knowledge Transfer Components.   

 

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1.48 Licensed Field Specific Patents ” means (i) the patents and patent applications listed in Ex hibit A , (ii) any divisionals, continuations, continuations-in-part (only to the extent a priority claim can be made), reissues, reexaminations, and extensions of the patents and patent applications described in (i), (iii) any foreign equivalents of the patents and patent applications described in (i) and (ii), and (iv) any patents that issue from such patent applications described in (i), (ii), and (iii).

 

1.49 Licensed IP ” means Licensed Patents, Licensed Know-How, Licensed Field Copyrights, and Illumina Software Code.

 

1.50 Licensed Know-How ” means Licensed Field Specific Know-How and Licensed Field General Know-How.

 

1.51 Licensed Patents ” means the Licensed Field Specific Patents and the Licensed Field General Patents.

 

1.52 Licensed Products ” means a product for either [...***...] for nucleic acid sequencing on an Illumina Sequencing Instrument or [...***...] of nucleic acid sequence data obtained from (i.e., downstream in a workflow from, and not located on) an Illumina Sequencing Instrument which product or service (i) uses the Illumina Chimerism Formulation and Illumina Chimerism Software or any improvement, enhancement, or modification of any of the foregoing made by or on behalf of CareDx or (ii) incorporates any [...***...], [...***...] and [...***...] or any [...***...]. For the avoidance of doubt, any CareDx Existing Products are not, and are not deemed to be, a Licensed Product and CareDx does not owe any royalty or other amounts to Illumina for any such CareDx Existing Products under this Agreement.

 

1.53 Licensed Service ” means any service performed for a third party that uses a Licensed Product.

 

1.54 Losses ” has the meaning set forth in Section 12.1.

 

1.55 Material Change ” means a material change to form, fit or function of any Illumina HLA Existing Product or Illumina [...***...] Reagent with respect to its written, published technical specifications (in effect on the date that the product ships from Illumina).

 

1.56 Net Sales ” means the gross amount invoiced by CareDx or its Affiliates for the Sale of a Licensed Product during the relevant three (3) month period during the Contract Year, minus the following deductions to the extent each is actually given or incurred or separately accounted for in the corresponding invoice: (i) value added taxes, sales taxes, consumption taxes, excise taxes or custom duties and government charges levied on the production, sale, transportation or delivery of such products and services; (ii) costs of insurance and transportation from the place of manufacture to the customer’s premises; (iii) credit, allowances and charge backs for rejections, returns, allowances or trades; and (iv) customary trade, quantity and cash and prompt payment discounts. Net Sales shall not include any amounts received or invoiced by CareDx or its Affiliates for using or disposing any Licensed Product for assuring internal product testing, validation or control, or obtaining regulatory approvals.  For any performance of a Licensed Service, the Net Sales amount for such Licensed Service shall be the average invoice amount of the Licensed Product(s) used in the Licensed Service as if such Licensed Product was Sold on its own in an arm’s-length transaction in the same three (3) month period, subject

 

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to the foregoing allowable deductions . For the avoidance of doubt, for the performance of a Licensed Service, the Net Sales amount for such Licensed Service will be used for purposes of determining royalties and the Licensed Product used in such Licensed Service will not be counted more than once or separately be subject to royalties .  For any Sale of Licensed Product s for non-monetary consideration, the Net Sales amount for each such Sale shall be the average invoice amount calculated from all sales of applicable Licensed Product s on their own in arm s-length transactions in the same three (3) month period , subject to the foregoing allowable deductions. If CareDx appoints a distributor to sell a Licensed Product, then only the amount invoiced by CareDx to such distributor shall be included in the calculation of Net Sales, not any amounts invoiced by the distributor to an end-user or other customer. In the case of any Combination Product, the Net Sales for such Combination Product for purposes of determining royalties shall be determined by mutual agreement of the Parties in good faith taking into account the relative value of the Licensed Product to the other product(s) included in the Combination Product.

 

1.57 Non-Chimerism Royalty Product ” means a Licensed Product that (i) has a Net Sales amount that is greater than $[...***...] per sample (e.g., a Licensed Product that is a 10-sample kit with a Net Sales amount of $[...***...] is $[...***...] per sample), (ii) is not used for a Chimerism Assay application.

 

1.58 Non-Illumina Sequencing Instrument ” means an instrument not sold by Illumina that performs the actual nucleic acid sequencing, not including ancillary instruments such as robotic liquid handlers that do not perform actual sequencing.

 

1.59 Person ” means an individual or firm, trust, corporation, partnership, joint venture (whether entity-based or by contract), limited liability company, association, unincorporated organization, or other legal or governmental entity.

 

1.60 Receiving Party ” has the meaning set forth in Section 10.1(a).

 

1.61 “[...***... ] ” means use of a Licensed Product in the Licensed Field for [...***...].

 

1.62 Representatives ” means a Party’s (and a Party’s Affiliates’) officers, directors, legal representatives, financial representatives, employees and agents.

 

1.63 Restriction Period ” means the period beginning on the Effective Date and ending on the later of the date that is either (a) the [...***...] anniversary of the Effective Date, or (b) the expiration or termination of [...***...].  [...***...]

 

1.64 RMA ” has the meaning set forth in Exhibit B .

 

1.65 Sell ” means to sell, distribute, lease, license, provide, or otherwise make available.  The terms “ Sale ,” “ Sold ,” and other forms of the term “Sell” have correlative meanings.

 

1.66 Substitute Product ” has the meaning set forth in Section 5.7.

 

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1.67 Supplied Product means the Illumina HLA Existing Products and the Illumina [ ...***... ] Reagents .  

 

1.68 Taxes ” has the meaning set forth in Section 9.8(a).

 

1.69 Term ” has the meaning in Section 13.1.

 

1.70 Territory ” means worldwide.

 

1.71 Third Party Knowledge Transfer Components ” has the meaning set forth in Section 8.2.

 

1.72 Trade Secret Information ” means Confidential Information owned or controlled by a Party that such Party, in good faith based on trade secret law, marks as a trade secret prior to sharing with the other Party.  

 

2. LICENSE GRANTS TO CAREDX

 

2.1 Licensed Intellectual Property .  Subject to the terms and conditions of this Agreement, Illumina hereby grants to CareDx:

 

(a) A non-transferable (except as expressly permitted in Section 14.5), non-sublicensable (except as permitted in Section 2.2) license under all rights owned or Controlled by Illumina in and to the Licensed Field Specific Patents to (i) make, have made (on CareDx’s behalf), use, Sell, have Sold, offer for Sale, import, and export any Licensed Product , and (ii) perform Licensed Services, both in the case of (i) and (ii) solely in the Licensed Field in the Territory during the Term.  The license granted in this Section 2.1(a) shall be exclusive for uses within subparts [...***...] and [...***...] of the Licensed Field during the Restriction Period only, and non-exclusive for such subparts for the remainder of the Term.  The license granted in this Section 2.1(a) shall be non-exclusive during the Term for subparts [...***...] through [...***...] of the Licensed Field.

 

(b) A non-exclusive, non-transferable (except as expressly permitted in Section 14.5), non-sublicensable (except as permitted in Section 2.2) license under all rights owned or Controlled by Illumina in and to the Licensed Field General Patents to (i) make, have made (on CareDx’s behalf), use, Sell, have Sold, offer for Sale, import, and export any Licensed Product, and (ii) perform Licensed Services, both in the case of (i) and (ii) solely in the Licensed Field in the Territory during the Term.

 

(c) A non-transferable (except as expressly permitted in Section 14.5) and non-sublicensable (except as expressly permitted in Section 2.2) license under all rights owned or Controlled by Illumina in and to the Licensed Field Copyrights and Illumina Software Code to copy, use, display and perform (publicly or otherwise), modify, create derivative works of, distribute, compile and otherwise commercialize and exploit Licensed Products solely in the Licensed Field in the Territory during the Term.  With respect to any Licensed Field Copyrights and Illumina Software Code that are specific only for use in the Licensed Field, the license granted in this Section 2.1(c) is exclusive during the Restriction Period for use within subparts [...***...] and [...***...] of the Licensed Field, and it is non-exclusive for the remainder of the Term and for uses within subparts [...***...] through [...***...] of the Licensed Field.  With respect to Licensed Field Copyrights and Illumina Software Code covering other uses outside of the Licensed Field, the license granted in this Section 2.1(c) shall be non-exclusive only.

 

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(d) A non-transferable (except as exp ressly permitted in Section 14.5 ) , non-sublicensable (except as permitted in Section 2.2 ) license under all rights owned or Controlled by Illumina in and to the Licensed Field Specific Know-How to (i) develop, make, have made (on CareDx ’s behalf), use, market, Sell, offer for Sale, import, export , commercialize , service, support and otherwise dispose of any Licensed Product, and (ii) perform Licensed Services , both in the case of (i) and (ii) solely in the Licensed Field in the Territory during the Term .  The license granted in this Section 2.1(d) shall be exclusive for uses within subpart s [ ...***... ] of the Licensed Field [ ...***... ] , and non-exclusive for such subpart s for the remainder of the Term.  The license granted in this Section 2.1( d ) shall be [ ...***... ] for uses within subparts [ ...***... ] through [ ...***... ] of the Licensed Field.

 

(e) A non-exclusive, non-transferable (except as expressly permitted in Section 14.5), non-sublicensable (except as permitted in Section 2.2) license under all rights owned or controlled by Illumina in and to the Licensed Field General Know-How to (i) develop, make, have made (on CareDx’s behalf), use, market, Sell, offer for Sale, import, export, commercialize, service, support and otherwise dispose of any Licensed Product, and (ii) perform Licensed Services, both in the case of (i) and (ii) solely in the Licensed Field in the Territory during the Term.

 

2.2 Sublicense . The foregoing licenses include the right for CareDx to allow its subsidiaries (but only for so long as they remain CareDx subsidiaries) and any third parties to exercise CareDx’s licenses but solely on behalf and for the benefit and account of CareDx (provided that if such third party is an acquirer of CareDx, the obligations of Section 14.5 shall apply). CareDx shall be responsible for any acts or omissions of any such subsidiary or third party exercising CareDx’s licenses on CareDx’s behalf under this Agreement. Subject to the terms and conditions of this Agreement, CareDx may sublicense its rights to a subsidiary (but only for so long as it remains a subsidiary of CareDx) to the extent necessary for such subsidiary to market, Sell, offer for Sale, import, export, commercialize and otherwise dispose of any Licensed Product; provided that any such sublicense shall be consistent with the terms and conditions of this Agreement and CareDx shall be responsible for such sublicensee’s compliance with such terms and shall provide prior written notice and a copy to Illumina of such sublicense.

 

2.3 No Other Licenses .  No license, sublicense or other rights granted in this Agreement includes any license, sublicense, right, immunity or authorization, either expressly, by implication, by estoppel or otherwise, (i) under any Intellectual Property that is not included in the Licensed IP, (ii) outside of the Licensed Field, or (iii) for use of products other than the Licensed Products.   N othing in this Agreement (i) grants a license to CareDx to any Intellectual Property covering nucleic acid sequencing chemistries, methods, reagents, flow cells, or instruments, or (ii) authorizes the use or Sale of any products that are not used with an Illumina Sequencing Instrument.

 

2.4 CareDx Commercialization and Milestones .  As between Illumina and CareDx, CareDx shall have sole responsibility for the development (except for Supplied Products), manufacture (except for Supplied Products), marketing, Sales, service, and support of Licensed Products in the Licensed Field.  CareDx shall use commercially reasonable efforts to: (i) develop, manufacture, market, Sell, service, and support Licensed Products in the Licensed Field in accordance with this Agreement, and (ii) satisfy each of the following milestones:

 

(a) First commercial availability of a Licensed Product for purchase by third parties that (i) uses the Illumina Chimerism Formulation and Illumina Chimerism Software, and (ii) is marketed for Chimerism Assay applications in the Licensed Field, by [...***...];

 

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(b) First commercial availability of a Licensed P roduct for purchase by third part ies that is a developed version of an assay incorporating the Illumina [ ...***... ] Reagents, Illumina HLA v3 [ ...***... ] , and Illumina HLA v3 Software by the later of (i) [ ...***... ] , or (ii) [ ...***... ] months after Illumina first delivers commercial p roduction Illumina [ ...***... ] Reagents to CareDx ; and

 

(c) Cumulatively spend at least $[...***...] between the Effective Date and the fifth anniversary of the Effective Date in incremental research and development, sales, marketing, and support of Licensed Products.

 

Notwithstanding anything to the contrary in this Agreement, if Illumina fails to: (i) complete the Knowledge Transfer in accordance with Section 8.1, (ii) supply the Supplied Products on the timing specified in this Agreement, or (iii) [...***...] then, in any of the foregoing cases, CareDx will be excused from meeting any of the above milestones by the specified dates above for the amount of time it takes Illumina to remedy any such failure. If CareDx fails to use commercially reasonable efforts to meet any of the above milestones by the specified date above for reasons other than (i) Illumina’s failure to complete the Knowledge Transfer, supply the Supplied Products or provide a Substitute Product, in each case, as set forth in the immediately preceding sentence or (ii) Force Majeure then, in such a case, Illumina may give written notice [...***...] and upon CareDx’s receipt of such notice, the Parties will promptly meet to discuss a resolution in good faith for a reasonable period of time mutually agreed upon by the Parties, but in any event not longer than 30 days unless the Parties agree to extend the discussion period, in which case the discussion period shall expire at the end of the extension period. In the event that (i) CareDx fails to meet any agreed upon resolution within any mutually agreed upon timing for such resolution, or (ii) no resolution is agreed upon by the expiration of the foregoing good faith discussion period and the milestone is still not achieved by the conclusion of such good faith discussions then, the licenses granted in this Agreement with respect to the Licensed Product for which CareDx failed to achieve the milestone [...***...]. For the avoidance of doubt, the Parties acknowledge and agree that neither (x) the failure by Illumina to complete the Knowledge Transfer or supply the Supplied Products within 5 days after the timing specified in this Agreement nor (y) the failure by CareDx to meet any milestone within 5 days after the specified date above shall, in either case, be deemed to be a material breach of this Agreement.   

 

3. IMPROVEMENTS BY CAREDX; FUTURE ILLUMINA TECHNOLOGY

 

3.1 License to Illumina .  Subject to the terms and conditions of this Agreement CareDx hereby grants to Illumina a non-exclusive, fully paid-up, worldwide, transferable (but only to the extent expressly permitted under Section 14.5), sublicensable (but only to its Affiliates for as long as they remain Illumina’s Affiliates) license (including the right to have third parties acting on behalf of Illumina but solely for the benefit and account of Illumina, provided that Illumina will remain responsible for the acts and omissions of its Affiliates or third parties under any such sublicense or this right) during the Term to use and exploit any Improvements to make, have made, use, sell, offer for sale, import, and

 

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export any product or service for use outside of the Licensed Field but only in certain fields mutuall y agreed upon by the Parties .   Care Dx shall provide written notice to Illumina of any Improvements at each quarterly meeting described in Section 6.1 (or if no such meeting occurs, then either (i) at least 30 days prior to the planned commercial launch of such Improvement , or (ii) within 5 days of a patent application being filed that claims all or any material portion of such Improvement, whichever is first ), and s uch notice shall describe the Improvements in a level of detail sufficient to enable Illumina to evaluate the Improvement to determine whether or not to exercise the Option set forth in Section 3.2 .

 

3.2 Illumina Option .  Subject to the terms and conditions of this Agreement, CareDx hereby grants to Illumina an exclusive option to receive a co-exclusive (with CareDx) license under all rights CareDx has or may have in any Improvements in certain fields mutually agreed upon by the Parties outside of the Licensed Field (the “ Option ”). Any definitive license agreement(s) will be on commercially reasonable terms negotiated in good faith, will be for use outside of the Licensed Field, and will be sublicensable to Illumina’s Affiliates (but solely for so long as they remain Illumina’s Affiliates) and, as part of any such license granted to Illumina from the exercise of its Option, Illumina may have third parties exercising its license on its behalf and solely for its benefit and account; provided that Illumina will remain responsible for the acts and omissions of its Affiliates or third parties under any such sublicense or this right.  Illumina may exercise its Option on a case by case basis by providing written notice of exercise to CareDx within [...***...] after receiving written notice of the Improvement in accordance with Section 3.1.  If (without in any way limiting the notice requirement) Illumina reasonably believes that no notice of the Improvement is provided, then the Parties will promptly meet to discuss in good faith the reason therefor and, if appropriate and the Parties believe in good faith that such Improvement is either intended to be commercially launched or intended to be patented (all or any material portion of such Improvement) then, in such a case, Illumina may exercise its Option for such Improvement by providing written notice of exercise to CareDx within [...***...] of the date the Parties first meet to discuss the same.  The Option, and any co-exclusive license(s) granted upon the exercise of the Option, will be subject to CareDx’s non-transferable (except as expressly permitted in Section 14.5), non-sublicensable (except as expressly permitted in Section 2.2), co-exclusive right to use and, in the Licensed Field commercialize, the Improvement for any purpose.  The Option will be binding on any assignee or other successor in interest of any Improvement.

 

3.3 Future Illumina Technology .  If requested in writing by CareDx (such request not to be made more than once every 6 months), Illumina shall engage in good faith discussions with CareDx about the potential application of technology created by or on behalf of Illumina after the Effective Date in the Licensed Field; provided that Illumina shall not be obligated to share any non-public information in such discussions.

 

4. SALES RESTRICTIONS

 

4.1 CareDx Restrictions .  For the period from the Effective Date until [...***...] or the termination of this Agreement, if earlier, CareDx and its Affiliates shall not, and shall not facilitate, grant licenses to, or assist a third party to, [...***...], [...***...] or [...***...]; provided that notwithstanding the foregoing, CareDx shall not be in breach of this Section 4.1: (a) for developing, making, having made (on CareDx’s behalf), using, marketing, Selling, offering for Sale, importing, exporting, commercializing, servicing, supporting and otherwise disposing of in the Licensed Field: (i) any current products or services of CareDx or its

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Affiliates , including Allosure and All oMap , or any products or services in development that are not intended for use in a next-generation nucleic acid sequencing workflow , in each case, as of the Effective Date, (ii ) any improvement s , enhancement s , modification s , update s , upgrade s or future equivalent s to any of the foregoing products or services not used in a next-generation nucleic acid sequencing workflow , (iii ) any natural evolutions or new versions that are based substantially on such products or services set forth in Section 4.1 (a) (i ) and/ or Section 4.1 ( a ) (ii) above (subsections (i), (ii) and (iii) above, collectively, “ CareDx Existing Products ”) , or (b ) if any of its distributors separately promote, recommend o r sell products or services in the Licensed Field that use Non-Illumina Sequencing Instruments which , other than CareDx Existing Products, are not provided to such distributor by CareDx or its Affiliate, directly or indirectly . For the avoidance of doubt and notwithstanding anything else in this Agreement or otherwise, the use of Allosure and Allomap, and any improvements, enhancements, modifications, updates or upgrades of, or future equivalents to Allosure or Allomap , will not be, and will not be deemed to be part of, the Licensed Field .

 

4.2 Illumina Restriction .   

 

(a) [...***...], neither Illumina nor any of its Affiliates shall, nor shall they collaborate with a third party to manufacture, develop, promote, launch or commercialize a product or service that Illumina knows is or will be promoted, designed, and intended specifically for use in subpart [...***...] or subpart [...***...] of the Licensed Field (“ Illumina Product Restriction ”).  For the avoidance of doubt, the Illumina Product Restriction will not apply to the extent that [...***...].

 

(b) Without limiting Section 4.2(a) or any exclusivity associated with the license grants in Section 2, nothing in this Agreement shall obligate Illumina or its Affiliates to (i) [...***...], or (ii) [...***...].

 

(c) If the exclusive licenses granted in this Agreement [...***...] with respect to a Licensed Product, [...***...].

 

(d) Upon the earlier of: (i) [...***...] and (ii) [...***...], develop, manufacture, promote, recommend, Sell or commercialize a product or service that otherwise would have been prohibited under Section 4.2(a); provided that [...***...]. Upon [...***...] will, in each of the foregoing cases, [...***...]. In the event that [...***...] for use in subpart [...***...] or subpart [...***...] of the

(a)

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Licensed Field in a [ ...***... ] that use s Non-Illumina Sequencing Instruments , or CareDx does so itself, then Illumi na shall have the right [ ...***... ] .

 

5. USE AND RE-SALE OF ILLUMINA PRODUCTS

 

5.1 Supply and Use of Illumina HLA Existing Products .  CareDx will purchase, and Illumina will Sell, Illumina HLA Existing Products in accordance with the pricing and the terms and conditions set forth in Exhibit B .  Illumina HLA Existing Products shall only be used in the Licensed Field, with an Illumina Sequencing Instrument, and in accordance with their Documentation.  All terms and conditions apply whether CareDx is purchasing such products for its own use or for re-Sale.  Illumina may, in its sole discretion, stop supply to CareDx of all Illumina HLA Existing Products on or after December 31, [...***...] (“ Supply Expiration Date ”); provided that Illumina will provide written notice of the same to CareDx more than six (6) months from the Supply Expiration Date. CareDx may place one last-time-buy order for the Illumina HLA Existing Products, for an amount of Illumina HLA Existing Products not to exceed [...***...]% of its most recent forecast provided to Illumina under this Agreement for the period between the last-time-buy order and the Supply Expiration Date, at least six (6) months prior to the Supply Expiration Date.  Illumina will supply the Illumina HLA Existing Products under the last-time-buy order by the delivery date set forth in such last-time-buy-order; provided that such delivery date is at or longer than Lead Time. To the extent that Illumina believes that such shipment may be delayed then, without limiting CareDx’s other rights or remedies, the Parties will discuss a revised shipping schedule for Illumina HLA Existing Products under the last-time-buy order in good faith.

 

5.2 Appointment of CareDx to Re-Sell Illumina HLA Existing Products .  Subject to the terms and conditions of this Agreement, including but not limited to this Section 5.2 and Exhibit C , Illumina hereby appoints CareDx as its exclusive (even as to Illumina and its Affiliates) distributor for the re-Sale of Illumina HLA Existing Products during the Term for use in the Licensed Field only, subject to the following:

 

(a) Such exclusivity shall commence on June 1, 2018, prior to which time the appointment shall be non-exclusive; provided that during such period Illumina will not, directly or indirectly, accept any new orders to Sell any of the Illumina HLA Existing Products to any distributors or similar third parties, and that both before and after the commencement of exclusivity, current distributors will be allowed to sell HLA Existing Products that are in inventory or have shipped to the distributor at the time of the Effective Date;

 

(b) The terms for transitioning Illumina’s existing obligations for sales and support of Illumina HLA Existing Products are set forth in Exhibit F ; and

 

(c) Notwithstanding the foregoing or otherwise, Illumina shall still have sole responsibility for the [...***...] customer account, and shall directly sell the Illumina HLA Existing Products to [...***...], in each case, until [...***...].

 

5.3 Supply and Use of Illumina [ ...***... ] Reagents .  CareDx will purchase, and Illumina will Sell, Illumina [...***...] Reagents in accordance with the pricing and the terms and conditions set forth in Exhibit B .  Illumina [...***...] Reagents shall only be used in the Licensed Field, with an Illumina Sequencing Instrument, and in accordance with their Documentation, and subject to the restrictions set forth in Section 5.4(a)-(c).  All terms and conditions apply whether CareDx is

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purchasing such Illumina [ ...***... ] Reagents for its own use or for re-S ale.  Illumina shall use commercially reasonable efforts to first make commercial production Illumina [ ...***... ] Reagents (for non- [ ...***... ] use) available for purchase under this Agreement no later than [ ...***... ] .

 

5.4 Appointment of CareDx to Re-Sell Illumina [ ...***... ] Reagents .  Subject to the terms and conditions of this Agreement, including but not limited to this Section 5.4 and Exhibit C , Illumina hereby appoints CareDx as its non-exclusive distributor for the re-Sale of Illumina [...***...] Reagents during the Term for use in the Licensed Field only, subject to the following additional restrictions on CareDx and any third parties that are re-Selling or using Illumina [...***...] Reagents purchased under this Agreement:

 

(a) Illumina [...***...] Reagents shall only be re-Sold and used as a component of a Licensed Product that provides [...***...];

 

(b) The configuration of Illumina [...***...] Reagents received from Illumina shall not be broken-up or diluted for use or re-Sale (e.g., a group of Illumina [...***...] Reagents intended for use with [...***...] samples may not be split up into kits for use with [...***...] samples, and may not be diluted for use with a kit for use with [...***...] samples); and

 

(c) Illumina [...***...] Reagents sold to CareDx for use in preparing libraries for up to [...***...] samples (with [...***...]) may only be used and re-Sold for [...***...].

 

Illumina agrees to consider in good faith any written proposals made by CareDx to modify the above restrictions in subsections (a) – (c) of this Section 5.4 to enable a bona fide opportunity for re-Sale of such products to a third party for use as [...***...] for [...***...].

 

5.5 Use of Subdistributors and Agents .  CareDx may, with Illumina’s prior written consent, appoint a distributor, agent, or other third party to promote or re-Sell Supplied Products. To the extent Illumina approves of a third party authorized by CareDx to re-Sell Supplied Products as its agent or otherwise on CareDx’s behalf , CareDx shall ensure that such third party enters into a written agreement with CareDx that binds such third party to terms that are at least as protective of Illumina as those under this Agreement, including without limitation terms relating to Illumina Intellectual Property, Illumina Confidential Information, anti-bribery, anti-corruption, and ethics. Illumina has the right to receive, upon written request, a copy of any written agreement entered into by CareDx with any such third party relating to Supplied Products in order to verify that the terms and conditions of any agreement comply with this Section 5.5. In all cases and at all times CareDx shall remain fully liable for performance, acts, and omissions of any third parties re-Selling the Supplied Products as its agent or otherwise on its behalf. Without limiting the foregoing, the aforementioned written agreement must include a prohibition on the third party registering any Supplied Products in any jurisdiction. For the avoidance of doubt, any other third party that receives a Supplied Product from CareDx (directly or indirectly), including any distributor or third party that is an end provider or supplier to customers of the Supplied Products that are not acting on CareDx’s behalf or as its agent, will be, and will be deemed to be, CareDx’s customer and be subject to the [...***... ] . In the event that: (a) CareDx becomes aware of any distributor, agent, or third party re-Seller: (i) re-Selling the Supplied Products [...***...], (ii) using the Supplied Products with

 

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a [ ...***... ] that does not [ ...***... ] in the Licensed Field , or (iii) using the Supplied Products [ ...***... ] , or (b) Illumina sends CareDx written notice of the same, CareDx shall promptly send a written notice to the applicable distributor or third party requesting that such distributor or third party ceases such activity. In the event that such distributor or third party does not cease such activity within thirty (30) days or such other reasonable period of time as may be set forth in any written agreement between CareDx and such dist ributor or third party , the Parties will promptly meet to discuss a resolution in good faith, which may include CareDx ’s enforcement of any one or more of its rights or remedies that may be available to it under any such written agreement for the benefit of Illumina.

 

5.6 Service and Support .  Absent any express language in the Transition Services Agreement, Illumina’s warranty-related obligations to CareDx for Supplied Products shall be as set forth in Exhibit B .  CareDx will be solely responsible for service and support of Supplied Products that it re-Sells.  Illumina and CareDx will enter into a Transition Services Agreement containing the services set forth in Exhibit E, without any additions or expansions, as promptly as possible after the Effective Date, but no later than 10 days after the Effective Date (or such longer period of time as may otherwise be agreed upon by the Parties).

 

5.7 Discontinuation/Changes to Illumina [ ...***... ] Reagents .  Supplied Products will not be manufactured in their current configurations indefinitely as a result of product life cycle or other business considerations.  A given Supplied Product may be phased out of production and no longer available and/or there may be a new, reconfigured, or repackaged version of a Supplied Product that embodies a Material Change (such discontinued or Materially Changed Supplied Product is referred to as a “ Discontinued Product ”).  Any product or combination of products that is intended by Illumina to replace such Discontinued Product shall be referred to as a “ Substitute Product ”; provided that: (i) in no event will there be a [...***...] and (ii) in addition to and without limiting the generality of its obligations under this Agreement, Illumina will [...***...]. Illumina will [...***...] at least [...***...] and will [...***...]. Subject to the foregoing, in some instances a Substitute Product may [...***...].  In other instances the Substitute Product may [...***...].  Upon receipt of the [...***...], and at any time prior to or on the [...***...], CareDx may [...***...] for the period between the [...***...] and the [...***...] but otherwise in accordance with [...***...]. In the case of a Discontinued Product that will have [...***...], Illumina will [...***...].  In the case of a Discontinued Product that will have [...***...], Illumina will [...***...].  Once a Discontinued Product is no longer available for purchase [...***...], Illumina will [...***...] and either of the following will occur: (i) [...***...]

 

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or (ii) [ ...***... ] .  The price for a Substitute Product will be [ ...***... ] .  Use of Substitute Products shall be subject to the terms and conditions of this Agreement.

 

5.8 Branding .  

(a) Branding for Supplied Products shall be performed by Illumina.  Branding for products or services containing Supplied Products that are re-Sold by CareDx shall be governed by Exhibit C , Section 3 (Labeling).

 

(b) CareDx shall market, promote and Sell the Licensed Products under one or more trademarks selected by CareDx (the “ CareDx Marks ”) either alone or, if requested by Illumina in combination with the Illumina logo and branding for Licensed Products that include Illumina [...***...] Reagents.  The CareDx Marks shall be owned solely and exclusively by CareDx.  Illumina shall have no rights to use the CareDx Marks.  Any use of the CareDx Marks and all associated goodwill will inure solely to the benefit of CareDx.  If Illumina requests the inclusion of Illumina’s logo or branding, the Parties will discuss in good faith the manner in which it will be incorporated, including but not limited to compliance with Illumina’s branding guidelines, Illumina’s right to approve prior to each use, and execution of a personal, limited, non-exclusive, royalty-free, and non-transferable trademark license.

 

5.9 Illumina HLA Existing Product Software .  CareDx shall, [...***...], provide to its customers [...***...] approximately every [...***...] months (including an [...***...] in [...***...]).

 

5.10 Illumina Sequencing Instruments . Illumina shall sell Illumina Sequencing Instruments and related sequencing consumables, in its reasonable discretion, separately to CareDx's customers in accordance with Illumina’s standard practices for such products.

 

6. MEETINGS

 

6.1 Information Sharing Meetings .  Each Party shall designate one representative as the relationship managers for this Agreement.  The representatives shall be the primary points of contact for the Parties regarding the activities contemplated by this Agreement and shall facilitate all such activities hereunder. Each Party’s representative will meet quarterly or as otherwise mutually agreed upon by the Parties to discuss each Party’s activities under this Agreement.  Attendance at such meetings may be in person or by telephone although the Parties shall meet in person at least once a year.  The location of such meetings shall alternate between locations designated by Illumina and locations designated by CareDx.  At each meeting the Parties will discuss the following topics at the request of the other Party:

 

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(a) Updates on CareDx’s marketing and commercialization efforts for Licensed Products;

(b) Updates on CareDx’s development efforts for Licensed Products;

(c) Updated list of individuals that possess Trade Secret Information or any third parties to whom Confidential Information was disclosed;

(d) Updates on CareDx’s progress for internalizing functions governed by the Transition Services Agreement, if applicable;

(e) Written notice of any Improvements that are intended for commercial launch or to be patented (all or any material portion of such Improvement);

(f) Ongoing and future market trends and developments in the Licensed Field.

 

6.2 Good Faith Discussions . In addition to and not in lieu or limitation of Section 3.3 and otherwise the Agreement, in the event that there are any additional [...***...] that CareDx would like to add non-exclusively to the Licensed Field then the Parties will discuss in good faith, at the request of either Party, including during any information sharing meetings whether or not to add any additional [...***...], as applicable, to the Licensed Field.

 

6.3 Minutes .  The representatives from the Parties shall designate one person to be responsible for preparing and circulating minutes of each meeting, setting forth an overview of the discussions at the meeting and a list of any actions, decisions or determinations made at such meeting.

 

7. OWNERSHIP; PROSECUTION; AND ENFORCEMENT OF LICENSED IP

 

7.1 Ownership of License IP .  As between Illumina and CareDx, Illumina and its licensors own all rights, title, and interest in and to all Licensed IP.  CareDx will not represent that it has any ownership interest in or to any Licensed IP .  

 

7.2 Prosecution and Enforcement .  Illumina retains the sole right to file, prosecute, maintain, defend, and enforce, in its sole discretion, the Licensed IP; provid ed that for Licensed Field Specific Patents and any Licensed Field Copyrights to the extent exclusively licensed to CareDx (“ Exclusive IP ”) :

 

(a) If CareDx provides Illumina with written notice (including a detailed description) of [...***...] and Illumina does not [...***...], then CareDx shall [...***...] and, in such a case, Illumina will [...***...], and, to the extent necessary [...***...].  If CareDx [...***...], it shall not [settle such lawsuit in any manner that could be detrimental to Illumina’s rights in Licensed IP or Illumina’s ability to enforce Licensed IP].  Illumina shall have the right to [...***...].  Any [...***...] from any such [...***...] in the Licensed Field, including from [...***...].

 

(b) If Illumina elects to: (i) abandon on-going prosecution of a patent application or (ii) stop maintenance of a patent, in each case, that is part of the Licensed Field Specific Patents, it shall

 

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notify CareDx in a reasonable timeframe and CareDx shall have the option to elect to continue prosecution of such patent application or maintenance of such patent, in each case, [ ...***... ] ; provided that Illumina shall agree to assign to CareD x , if CareDx so desires, any such patent application and patent that Illumina desires to abandon or no longer wants to maintain , as applicable . Effective as of the effective date of the assign ment, such patent application and patent , as applicable, shall no longer be a Licensed Patent and CareDx shall not have any further royalty or other payment obligation to Illumina for such patent application or patent.

 

8. TECHNOLOGY TRANSFER

 

8.1 Knowledge Transfer .  The Parties have agreed on a knowledge transfer for Licensed Know-How relating to the Illumina HLA v3 [ ...***... ], Illumina HLA v3 Software, Illumina Chimerism Formulations, and Illumina Chimerism Software, the details of which are expressly set forth in Exhibit D (“ Knowledge Transfer ”).  The Parties shall use commercially reasonable efforts to complete the Knowledge Transfer no later than two (2) months after the Effective Date.  The Parties acknowledge that Illumina is not required to provide anything that is not in its possession or control or which cannot be accessed, identified, and/or located using commercially reasonable efforts, and is not required to provide additional manufacturing, new materials, or quality control or other processes beyond what exists as of the Effective Date. Notwithstanding the foregoing, and subject to Illumina’s using commercially reasonable efforts to complete the Knowledge Transfer in accordance with this Section 8.1,if at any time prior to the [ ...***... ] of the Effective Date CareDx identifies any documents, data, information or materials that are within the Licensed IP and either (a) reasonably necessary for CareDx to exercise its rights or perform its obligations under this Agreement or (b) used by Illumina or any of its Affiliates prior to the Effective Date to exercise their rights in and to the Licensed IP for the library preparation phase (including, for the avoidance of doubt, Know-How relating to the [ ...***... ] licensed under this Agreement) or [ ...***... ] in the Licensed Field or (c) in the case of Illumina HLA v3 [ ...***... ], prior versions of such [ ...***... ] that were used by Illumina or any of its Affiliates prior to the Effective Date for the Licensed Field but were not, in any of the foregoing cases, previously delivered to CareDx, then in such a case, CareDx shall identify such documents, data, information or materials to Illumina and the Parties will discuss in good faith as to whether or not such documents, data, information, or materials should have been included in the Knowledge Transfer.  If the Parties in good faith determine that inclusion is appropriate, Illumina will provide CareDx in a reasonable timeframe with such documents, data, information or materials that are in its possession or control or that Illumina can access and/or locate using commercially reasonable efforts.

 

8.2 Third Party Components .  CareDx acknowledges that certain components of the Illumina technology described in Section 8.1 are sourced by Illumina from third parties as listed on Exhibit G attached hereto and incorporated herein (“ Third Party Knowledge Transfer Components ”).  CareDx acknowledges that Illumina will be limited in its ability to provide certain materials and information in the Knowledge Transfer relating to the Third Party Knowledge Transfer Components, and CareDx must negotiate its own supply and rights to obtain any necessary information relating to Third Party Knowledge Transfer Components and to obtain Third Party Knowledge Transfer Components themselves.  No Intellectual Property rights, information, or materials relating to Third Party Knowledge Transfer Components are included in the licenses granted in Section 2.1.  

 

9. PAYMENTS; MINIMUM PURCHASE OBLIGATIONS

 

1.1

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9.1 Upfront Fee .  No later than 10 days after the Effective Date, CareDx shall pay to Illumina a one-time , non-refundable fee in the amount of $5,000,000 .

 

9.2 Minimum Purchase Obligation .  CareDx shall purchase at least the following amounts of Supplied Products for each Contract Year listed in the table below, subject to the following:

 

(a) Royalties paid under Section 9.3 in a Contract Year shall count towards the minimum amounts required in the table below for such Contract Year;

 

(b) If in a Contract Year, CareDx exceeds the minimum amount set forth below for such Contract Year, the amount in excess shall be counted towards future Contract Years until it is exhausted; and

 

(c) If CareDx fails to meet the minimum amount set forth below in a Contract Year, it shall have until [...***...] after the expiration of the applicable Contract Year to remedy such shortfall (in addition to the minimum amount set forth for the following Contract Year).

 

(d) The minimum purchase obligations under this Section may terminate earlier pursuant to Section 4.2(c) above.

 

(e) Illumina may, in its sole discretion any time after the third anniversary of the Effective Date, terminate the minimum purchase obligations under this Section by providing written notice to CareDx.

 

Contract Year

Minimum Amount

1

$[ ...***... ]

2

$[ ...***... ]

3

$[ ...***... ]

4

$[ ...***... ]

5

$[ ...***... ]

 

9.3 Royalties .  CareDx shall pay Illumina the following earned royalties during the Term:

 

(a) [...***...]% on [Net Sales of Non-Chimerism Royalty Products minus ($[...***...] * quantity of Non-Chimerism Royalty Products included in such Net Sales calculation)]; and

 

(b) [...***...]% on Net Sales of Chimerism Royalty Products.

 

Earned royalties are not owed for Sales of Illumina HLA Existing Products.  If this Agreement is still in effect at the time of expiration of the last-to-expire Licensed Patent, and if applicable law requires decreased royalty rates due to such expiration, then the Parties will negotiate such new rates in good faith.

 

9.4 Payments and Reports .  CareDx will pay the amounts due under Section 9.2 and concurrently submit a written royalty report to Illumina within 30 days after the end of each 3 month period of the Contract Year.  This report will state the quantity, description and aggregate Net Sales of each Licensed Product on a country-by country basis during the completed 3 month period, along with

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any applicable deductions applied in deriving the Net Sales amount.  Royalty reports are to be sent to:  Director, Accounting at the address as given in Section 14.7 .   Royalty payments shall be made by wire transfer as directed by Illumina in writing.   If no royalty-bearing Sales are made during the applicable period, a report shall still be sent in accordance with this Section 9.4 stating that no Sales were made.

 

9.5 Audit Rights .  CareDx agrees to, and will cause its Affiliates to, keep complete and accurate records of Sales and use (for Licensed Services) of Licensed Products in sufficient detail to enable evaluation of CareDx’s compliance with this Agreement and to enable the royalties due hereunder to be determined.  Such records shall be maintained for five years following the end of the calendar year to which they pertain.  Upon at least 30 days’ prior written notice from Illumina (unless such audit is “for cause,” in which case no more than 5 business days’ prior written notice is required), CareDx agrees to permit during CareDx’s regular business hours an independent certified public accountant, who is subject to written obligations of confidentiality at least as protective as those provided in this Agreement, to periodically examine, at Illumina’s expense and not more frequently than once every calendar year, books, ledgers and records for the sole purpose of verifying the payments made by CareDx pursuant to this Agreement.  If any amounts due to Illumina are ultimately determined to have been underpaid in an amount equal to or greater than [...***...]% of the total amount due during the period examined, then CareDx will pay the reasonable cost of the examination and the balance of the total amount due. Any undisputed amount due a Party under this Section 9.5 shall be paid within 30 days after receipt of an invoice for same.  

 

9.6 Currency Conversion .  All payments made under this Agreement will be in U.S. Dollars.  If any amount applicable to a payment under this Agreement is initially received or invoiced or calculated in a currency other than U.S. Dollars, then the amount will first be determined in the applicable foreign currency and then converted into equivalent U.S. Dollars using the exchange rate quoted on www.oanda.com or its successor site, or another well recognized currency exchange rate service in the event that www.oanda.com or a successor site is no longer available.  

 

9.7 Interest .  If CareDx fails to make any royalty payment under this Agreement after the date such payment is due as set forth in this Agreement, then interest will accrue on such payment amount on a daily basis from the date such payment was originally due until such payment is paid in full to Illumina at a rate of 1.5% per month or, if lower, the maximum interest rate allowed by applicable law.  CareDx will pay such interest to Illumina when such payment is actually made.  CareDx’s obligation to pay interest on such late payments as set forth in this Section 9.7 will not be construed to limit or restrict Illumina’s right to any other rights or remedies which may be available to it, including any right Illumina may have to terminate this Agreement.

 

9.8 Taxes .

 

(a) Each Party is and will be responsible for payment of all taxes, duties, levies, fees, excises or tariffs (“ Taxes ”) that it is obligated to pay pursuant to applicable laws, and no Party is or will be responsible for, or incur any liability on account of, any Taxes payable by any other Party.

 

(b) If CareDx is required to withhold any Taxes from any payment made to Illumina or any of its Affiliates under this Agreement, CareDx will remit and provide Illumina with evidence that CareDx has remitted such Taxes to the relevant taxing authority and pay Illumina or the applicable Affiliate the remaining amount.  Each Party shall provide reasonable assistance and cooperation to the other Party to, as permitted by law, reduce the amount of any withholding taxes or enable the recovery of any value

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added tax or tax credit , or similar obligations resulting from payments made under this Agreement, including providing any tax forms requested by the other Party ; provided that neither Party shall have any obligation to provide assistance or cooperation that may reasonably expose it to any liability.  

 

10. CONFIDENTIAL INFORMATION

 

10.1 Disclosure and Use Restriction .

 

(a) Except to the extent expressly authorized in this Agreement for a Party to exercise its rights or perform its obligations or as otherwise agreed in writing by the Parties, a Party (“ Receiving Party ”) receiving, obtaining or otherwise having access to any Confidential Information of the other Party (“ Disclosing Party ”) will keep confidential and may not publish or otherwise disclose or transfer any of the Disclosing Party’s Confidential Information to any third party.  Licensed Know-How is the Confidential Information of Illumina.

 

(b) The Receiving Party will use at least the same standard of care as it uses to protect proprietary or confidential information of its own to ensure that it and its Representatives do not make any unauthorized disclosures or use of the Disclosing Party’s Confidential Information.  The Receiving Party will promptly notify the Disclosing Party upon discovery of any unauthorized disclosure or use of the Disclosing Party’s Confidential Information.

 

(c) Each Party’s confidentiality and non-use obligations in this Agreement with respect to the Confidential Information of the other Party will continue throughout the Term and for 5 years thereafter.

 

10.2 Authorized Disclosure .  The Receiving Party may disclose the Disclosing Party’s Confidential Information to the extent that such disclosure is:

 

(a) made in response to a valid order of a court of competent jurisdiction or other governmental authority; provided, however, that such Receiving Party will, to the extent permitted by applicable law, give written notice to the Disclosing Party within 5 business days after receipt of such order and give the Disclosing Party a reasonable opportunity to quash such order and to obtain a protective order requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or governmental or regulatory body or, if disclosed, be used only for the purposes for which the order was issued; and provided, further, that if such disclosure order is not quashed or a protective order is not obtained, the Confidential Information disclosed in response to such court or governmental order will be limited to that information which is legally required to be disclosed in response to such court or governmental order;

 

(b) otherwise required by applicable law, rule, or regulation (other than the laws, rules or regulations of the Securities and Exchange Commission or a nationally recognized stock exchange, which is governed by Section 10.5 below); provided, that the Disclosing Party will provide the Receiving Party with written notice of such disclosure at least 30 days in advance thereof to the extent practicable and permitted by applicable law, rule, or regulation and will reasonably consider any comments received from the Disclosing Party;

 

(c) made for purposes of defending or enforcing the Licensed IP in a litigation, legal proceeding, or administrative case; or

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(d) made by the Receiving Party with the prior written consent of the Disclosing Party.

 

10.3 Authorized Use .  The Receiving Party may use the Disclosing Party’s Confidential Information solely to the extent necessary for the Receiving Party to perform its obligations and exercise its express rights under this Agreement without obtaining the Disclosing Party’s prior written consent (except to the extent such Confidential Information constitutes Trade Secret Information of the Disclosing Party); provided that any affiliates, distributors or third parties who need to know such Confidential Information for the performance of the Receiving Party’s obligations or exercise of the Receiving Party’s express rights will, in each case, be bound by restrictions regarding disclosure and use of such Confidential Information.

 

10.4 Trade Secret Information .  In addition to the protections afforded to Confidential Information in Section 10.1, each Party shall also abide by the following for the other Party’s Trade Secret Information:

 

(a) Trade Secret Information shall not be shared, without the prior written consent of the disclosing Party with any individuals that are not employees of the recipient Party;

 

(b) Each Party shall identify, in accordance with Section 6.1, the individuals that have access to the other Party’s Trade Secret Information; and

 

(c) Each Party will treat Trade Secret Information with the same degree of care with which it treats its own trade secrets, which shall be a higher degree of care than that afforded to other Confidential Information.

 

10.5 Agreement; Publicity .  The Parties agree to keep the existence and terms of this Agreement confidential and not disclose such existence or terms except (i) with the other Party’s written consent, which consent shall not be unreasonably withheld, conditioned or delayed, (ii) as may be required by law or rules or regulations of the Securities and Exchange Commission or a nationally recognized stock exchange (including the filing of a Current Report on Form 8-K with the Securities and Exchange Commission), (iii) to legal counsel, accountants , lenders and financial advisors, (iv) in connection with any action or claim to enforce its rights hereunder or in any related transaction, and (v) in connection with a financing or transaction in which all or substantially all of the other Party’s business, assets or equity is proposed to be sold, assigned or otherwise transferred.  Subject to Section 10.2 above, each Party must obtain the prior written consent of the other Party for all press releases or other public announcements relating to this Agreement; provided that notwithstanding the foregoing or otherwise, neither Party needs to obtain the prior written consent of the other Party if the Party is repeating a public announcement that is substantially similar to a public statement that the other Party previously approved and provided further that notwithstanding the foregoing or otherwise, neither Party needs to obtain the prior written consent of the other Party to the extent such press release or other public announcement is required by law or rules or regulations of the Securities and Exchange Commission or a nationally recognized stock exchange (including the filing of a Current Report on Form 8-K with the Securities and Exchange Commission).

 

10.6 Post-Termination .  Following expiration or termination of this Agreement for any reason, upon the written request of the Disclosing Party, the Receiving Party will, at the Disclosing Party’s option, promptly (i) return all materials containing any of the Disclosing Party’s Confidential Information to the Disclosing Party or (ii) destroy all materials containing any of the Disclosing Party’s Confidential

 


 

Information and certify such destruction in writing to the Disclosing Party; provided that the Receiving Party will be authorized to retain one copy of the Disclosing Party’s Confidential Information in its Legal Department for the sole purpose of determining any continuing obligation of the Receiving Party with respect to the Disclosing Party’s Confidential Information.  Notwithstanding the foregoing, the Receiving Party will not be required to destroy or delete electronic copies (including emails) that have become embedded in its electronic storage systems through routine backup processes.  Any of the Disclosing Party’s Confidential Information so retained by the Receiving Party will continue to be subject to all of the confidentiality, non-use, and other terms of this Agreement.

 

11. REPRESENTATIONS AND WARRANTIES; WARRANTY DISCLAIMER

 

11.1 Representations and Warranties .  Each Party represents and warrants that:

 

(a) it is duly organized, validly existing and in good standing under the laws of jurisdiction of domicile, and has all requisite power and authority to carry on its business as such business is now being conducted;

 

(b) this Agreement has been duly authorized, executed, and delivered by such Party and constitutes the legal, valid and binding obligation of such Party, enforceable against such Party in accordance with its terms, except as enforceability may be limited by applicable law relating to bankruptcy, receivership, or similar laws affecting creditors’ rights generally or by equitable principles relating to enforceability;

 

(c) it has all necessary rights, powers, and authority to enter into this Agreement and to carry out its obligations hereunder; and

 

(d) It will comply with all applicable law and regulations in exercising its rights or performing its obligations under this Agreement, including all applicable trade, corruption, commercial bribery, anti-money laundering and anti-terrorism laws such as the U.S. Foreign Corrupt Practices Act.

 

11.2 Illumina Representations and Warranties .  Illumina hereby represents and warrants to CareDx that (i) it (or its Affiliate) holds all right, and title to, or otherwise has the right to license or sublicense the Licensed IP; (ii) the grant of the licenses hereunder do not violate the terms of any agreement it has entered into with a third party relating to the Licensed IP; (iii) there are no written Claims or, to the best of its knowledge, other Claims pending related to the Supplied Products or use or Sale thereof; and (iv) throughout the Term, Illumina will maintain ownership of the Licensed Field Specific Patents and will not assign or abandon any such Licensed Field Specific Patents except as expressly permitted under Section 7.2(b) above.

 

11.3 CareDx Representation and Warranty .  CareDx hereby represents and warrants to Illumina that (a) for any Licensed Product, CareDx shall have obtained all of the necessary rights directly from the suppliers of the Third Party Knowledge Transfer Components to conduct such activities as they relate to Third Party Knowledge Transfer Components prior to conducting such activities; and (b) for any open source software transferred in the Knowledge Transfer or used in a Licensed Product that are specified in any related documentation or identified by Illumina, in each case, as part of the Knowledge Transfer, CareDx shall not take any action or inaction that would obligate Illumina or affect any of Illumina’s assets or rights.

 

 


 

11.4 WARRANTY DISCLAIMER .  THE EXPRESS WARRANTIES IN THIS SECTION 1 1 AND IN THE OTHER PROVISIONS OF THIS AGREEMENT ARE THE PARTIES’ EXCLUSIVE WARRANTIES WITH RESPECT TO THIS AGREEMENT AND , TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, EACH PARTY HEREBY DISCLAIMS ALL OTHER EXPRESS OR IMPLIED WARRANTIES (INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY, NONINFRINGEMENT OF THIRD PARTY RIGHTS except as expressly provided otherwise in this Agreement , AND FITNESS FOR A PARTICULAR PURPOSE).   

 

12. ALLOCATION OF RISKS  

 

12.1 CareDx’s Indemnification Obligation .  CareDx will defend, indemnify, and hold Illumina, each of its Affiliates, and Illumina’s and each of its Affiliates’ respective Representatives harmless from and against any and all suits, claims, proceedings, and causes of action, in each of the foregoing cases, brought by any third party (“ Claim(s) ”), and all damages, liabilities, expenses, and losses, including reasonable legal expenses and reasonable attorneys’ fees, arising out of or resulting from such Claims (“ Losses ”), arising out of or resulting from: (i) CareDx’s gross negligence, willful misconduct, or failure to comply with any applicable law, in each case in connection with its performance under this Agreement; (ii) CareDx’s breach of this Agreement (including any representation or warranty of CareDx set forth in this Agreement); or (iii) the manufacture, use, offer for Sale, Sale, commercialization, or other exploitation of any of the Licensed Products by or on behalf of CareDx, its Affiliates, or its agents or distributors; in each case (i), (ii) and (iii), except to the extent arising out of or resulting from (x) the conduct of Illumina or its Affiliates described in Section 12.2 or (y) any Claim that Licensed IP as and in the form delivered to CareDx infringes, misappropriates or otherwise violates the Intellectual Property or proprietary rights of a third party (other than infringement of any patent to the extent that such Licensed IP was not previously commercialized or otherwise exploited in a commercially available product or service by or for Illumina prior to the Effective Date).

 

12.2 Illumina’s Indemnification Obligations .  Illumina will defend, indemnify, and hold CareDx, its Affiliates and CareDx’s and its Affiliates’ respective Representatives harmless from and against any and all Claims and Losses arising out of or resulting from: (i) Illumina’s or its Affiliate’s gross negligence, willful misconduct, or failure to comply with applicable law, in each case in connection with its performance under this Agreement; (ii) Illumina’s breach of this Agreement (including any representation or warranty set forth in this Agreement); (iii) any Claim that the Licensed IP as and in the form delivered to CareDx infringes, violates, or misappropriates the Intellectual Property or proprietary rights of any third party (other than infringement of a third party’s patent right to the extent that such Licensed IP was not previously commercialized or otherwise exploited in a commercially available product or service by or for Illumina prior to the Effective Date); (iv) product liability, personal injury or other tort arising from Illumina’s supply of the Supplied Products or the negligence of Illumina, its Affiliates, their respective Representatives or any other party for whom Illumina is responsible; or (v) any Claim that the Supplied Products infringe, misappropriate or otherwise violate the Intellectual Property rights of a third party where, for Illumina [...***...] Products only, such claim is not brought specifically for the Licensed Field, except that Illumina will not have any indemnity obligation with respect to (w) any modifications made to a Supplied Product by CareDx or a third party not in accordance with the Documentation or specifications for such Supplied Products if such Supplied Product would not be infringing but for such modification, (x) combination of Supplied Products with other products that are not Supplied Products and not in accordance with the Documentation or specifications for such Supplied Products if such Supplied Product would not be infringing but for such combination; (y) use of the Supplied Products by CareDx or a third party not in accordance with the Documentation or specifications for such Supplied Products or such use that is not part of the normal or

 

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intended use of such Supplied Products , or (z) Claims arising out of or resulting from conduct of CareDx or its A ffiliate described in Section 12.1 .

 

12.3 THE FOREGOING CONSTITUTES THE SOLE INDEMNIFICATION OBLIGATIONS OF EACH PARTY AND THEIR AFFILIATES IN CONNECTION WITH THIS AGREEMENT.

 

12.4 Indemnification Procedures .  Each Party’s obligations under Section 12.1 and Section 12.2 are conditioned on the Party seeking indemnification: (i) giving the indemnifying Party reasonably prompt written notice of the Claim; provided, however, that failure to provide such notice will not relieve the indemnifying Party from its liability or obligations under this Section 12, except to the extent of any material prejudice as a direct result of such failure; (ii) reasonably cooperating with the indemnifying Party, at the indemnifying Party’s expense, in connection with the defense and settlement of the Claim, including using commercially reasonable efforts to provide accurate and complete information requested by the indemnifying Party; and (iii) permitting the indemnifying Party to solely control the defense and settlement of the Claim; provided, however, that the indemnifying Party may not settle the Claim, enter into or otherwise consent to an adverse judgment or order, or make any admission as to liability or fault that would adversely affect the indemnified Party, without the indemnified Party’s prior written consent, which will not be unreasonably withheld or delayed.  Further, the indemnified Party will have the right to participate (but not control) and be represented in any legal proceeding by counsel of its selection at its own cost.

 

12.5 Insurance .  Each Party will obtain and maintain insurance coverage as follows: a policy for commercial general liability and insurance (including product liability insurance) in the amount of no less than $[...***...] per occurrence to protect the other Party’s indemnitees under the indemnification provided under this Agreement.  Upon a Party’s request, the other Party will provide appropriate certificates of insurance.  The Parties will maintain such insurance at all times during the Term.

 

13. TERM AND TERMINATION

 

13.1 Term .  This Agreement will commence on the Effective Date and, unless terminated earlier in accordance with this Agreement, will continue in full force and effect.  The period from the Effective Date to the date this Agreement terminates or expires is the “ Term .”

 

13.2 Termination .  In addition to and without limiting any other rights of termination expressly provided in this Agreement or under applicable law, this Agreement may be terminated as follows:

 

(a) Breach of Provision .  If a Party materially breaches any provision of this Agreement and fails to cure such breach within 30 days after receiving written notice of such breach from the other Party, the non-breaching Party may terminate this Agreement with immediate effect by providing written notice of termination to the breaching Party.  If a material breach is not reasonably capable of being cured within such 30 day period, and the breaching Party is taking reasonable steps to cure such breach, the non-breaching Party will provide a commercially reasonable extension of the cure period, not to exceed 30 additional days. For the avoidance of doubt, CareDx will not be deemed to have breached its obligations under Sections 2.4 and 9.2 of this Agreement to the extent that such failure is caused by Illumina’s failure to: (i) complete the Knowledge Transfer in accordance with Section 8.1, (ii) supply the Supplied Products on the timing specified in this Agreement or (iii) provide a Substitute Product to replace any Discontinued Product that both passes CareDx’s reasonable validation tests (that

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are no more stringent than those used to validate the Discontinued Product) and is not at a higher cost to CareDx on a per sample basis pursuant to Section 5.7 .

 

(b) Bankruptcy and Insolvency .  A Party may terminate this Agreement, effective immediately upon written notice, if the other Party becomes the subject of a voluntary or involuntary petition in bankruptcy, for winding up of that Party, or any proceeding relating to insolvency, receivership, administrative receivership, administration liquidation, or similar proceeding that is not dismissed or set aside within 60 days.

 

(c) Failure to Satisfy Minimum Purchase Obligation .  Illumina may [...***...] to CareDx if CareDx fails to satisfy any of its minimum purchase obligations in Section 9.2 except to the extent that such a failure arises from: (i) Illumina’s failure to: (x) complete the Knowledge Transfer in accordance with Section 8.1, (y) supply the Supplied Products on the timing specified in this Agreement or (z) [...***...] or (ii) CareDx’s minimum purchase obligations are otherwise excused, suspended or extended under this Agreement, including under Sections 4.2(c), 5.7 or 9.2 of this Agreement and/or Section 3 of Exhibit F.

 

(d) Failure by Assignee .  If this Agreement is assigned or otherwise transferred by a party other than Illumina under Section 14.5(a), and such assignee or transferee fails to satisfy the conditions set forth in Section 14.5(a), [...***...].

 

13.3 Effect of Termination; Survival .  

 

(a) The following provisions will survive any termination or expiration of this Agreement: Sections 1, 5.8(b) (but only with respect to the second, third and fourth sentences), 7.1, 9.5, 9.6, 9.7, 9.8, 10, 11, 12.1, 12.2, 12.3, 12.4, 13.3, 13.4, 13.5, 14, and Section (h) of Exhibit B .  For clarity, upon any termination or expiration of this Agreement, all licenses and rights granted by Illumina to CareDx will immediately terminate and revert back to Illumina, except with respect to CareDx’s sell-off right set forth in Section 13.3(b).

 

(b) Upon termination or expiration of this Agreement, CareDx shall have the right to sell off any Licensed Products and Illumina HLA Existing Products that have been manufactured or are in the process of being manufactured at the time of termination or expiration and to perform any Licensed Services for which it has accepted purchase orders prior to the effective date of termination or expiration, provided that, such sales and services are made in the normal course consistent with CareDx’s past practice and CareDx continues to comply with all of the provisions of this Agreement governing its manufacture, use, and Sale of Licensed Products and Illumina HLA Existing Products (including its payment, reporting and audit obligations under Section 9).

 

(c) Termination or expiration of this Agreement will not (i) relieve either Party of any liability or obligation that accrued under this Agreement prior to the effective date of such termination or expiration (including any payment obligations) or (ii) preclude either Party from pursuing all rights and remedies it may have under this Agreement, at law, or in equity with respect to any breach of this Agreement.

 

1.1

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13.4 NO DAMAGES FOR TERMINATION OR EXPIRATION .  NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR ANY DAMAGES OF ANY KIND (INCLUDING DAMAGES ON ACCOUNT OF PRESENT OR PROSPECTIVE PROFITS, OR ON ACCOUNT OF EXPENDITURES, INVESTMENTS OR COMMITMENTS MADE IN CONNECTION WITH THIS AGREEMENT, OR IN CONNECTION WITH THE DEVELOPMENT OR MAINTENANCE OF THE BUSINESS OR GOODWILL OF THE OTHER PARTY) BY REASON OF EXPIRATION OF THIS AGREEMENT OR PROPER EXERCISE OF ITS RIGHT TO TERMINATE THIS AGREEMENT IN ACCORDANCE WITH THE TERMS AND CONDITIONS SET FORTH IN THIS AGREEMENT, AND EACH PARTY HEREBY EXPRESSLY WAIVES ANY RIGHT IT MAY HAVE TO RECEIVE ANY SUCH DAMAGES.  NOTWITHSTANDING THE FOREGOING, NOTHING HEREIN SHALL PROHIBIT EITHER PARTY FROM COLLECTING DAMAGES RESULTING FROM A PARTY’S FRAUDULENT OR FAILED ATTEMPT TO TERMINATE THIS AGREEMENT AS DETERMINED BY A COURT OF COMPETENT JURISDICTION.

 

13.5 LIMITATION OF LIABILITY .  EXCEPT FOR (1) A BREACH OF SECTION 10, (2) CLAIMS OF A THIRD PARTY THAT ARE SUBJECT TO INDEMNIFICATION UNDER SECTION 12, OR (3) IN THE CASE OF GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF A PARTY, NEITHER PARTY, NOR ANY OF THEIR RESPECTIVE AFFILIATES, WILL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES FOR ANY INDIRECT, CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES OR LOST PROFITS OR ROYALTIES, LOST DATA OR COST OF PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES, WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY) OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS es OR DAMAGES.

 

14. GENERAL

 

14.1 Dispute Resolution; Governing Law; Jurisdiction .  Either Party shall have the right to refer any dispute between the Parties in writing to a senior executive officer of each Party, and such senior executive officers shall attempt in good faith to resolve such dispute.  If the Parties are unable to resolve a given dispute within 30 days after referring such dispute to the senior executive officers, either Party may have the given dispute settled in court pursuant to this Section 14.1.  This Agreement and any dispute or claim arising out of, in connection with or related to this Agreement or its subject matter or formation will be governed and construed in accordance with the laws of the State of California, without regard to provisions on the conflicts of laws. Any legal action to resolve any dispute under this Agreement will take place in Los Angeles, California, and the Parties expressly waive any objections to such venue. The Parties agree that the United Nations Convention on Contracts for the International Sale of Goods does not apply to this Agreement.

 

14.2 Injunctive Relief; Cumulative Remedies . Each Party acknowledges that its breach of Section 10 or any actual or potential infringement or misappropriation of the other Party’s Intellectual Property rights may cause irreparable injury to the other Party for which monetary damages would not be an adequate remedy, and the other Party will therefore be entitled to seek injunctive relief (including specific performance) with respect to any breach or threatened breach without posting a bond or other security as a condition for obtaining any such relief. The rights and remedies provided to each Party in this Agreement are cumulative and in addition to any other rights and remedies available to each Party under this Agreement, at law or in equity.

 

14.3 Affiliates; Rights of Third Parties .  Illumina may delegate or subcontract any or all of its rights and obligations under this Agreement to one or more of its Affiliates; provided that Illumina shall remain fully responsible and liable for any act or omission on the part of its Affiliates (relating to their

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performance for Illumina under this Agreement) .   Illumina invoices and other documentation may come from any Affiliate of Illumina, and CareDx will honor those just as if they came directly from Illumina.   Except to the extent expressly stated ot herwise , this Agreement is personal to CareDx .  Except as expressly provided with respect to each Party’s indemnification obligations, there are no third party beneficiaries to this Agreement, and no term of this Agreement is enforceable by a Person who is not a Party to this Agreement. The Parties may rescind or terminate this Agreement or vary any of its terms in accordance with their rights under this Agreement and by applicable law , including in accordance with Section 14.9 below , but without the consent of any third party.

 

14.4 Severability; No Waiver .  If any term or provision of this Agreement is invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability will not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction.  Upon a determination that any term or provision is invalid, illegal or unenforceable, the Parties will negotiate in good faith to modify this Agreement to effect the original intent of the Parties as closely as possible in order that the transactions contemplated by this Agreement be consummated as originally contemplated by the Parties to the greatest extent possible.  The failure or delay of either Party to exercise any right or remedy provided in this Agreement or to require any performance of any term of this Agreement may not be construed as a waiver, and no single or partial exercise of any right or remedy provided in this Agreement, or the waiver by either Party of any breach of this Agreement, will prevent a subsequent exercise or enforcement of, or be deemed a waiver of any subsequent breach of, the same or any other term of this Agreement.  No waiver of any right, condition, or breach of this Agreement will be effective unless in writing and signed by both Parties.  

 

14.5 Assignment .

 

(a) Neither Party may assign or otherwise transfer, or delegate any of its obligations under, this Agreement or any rights or obligations under this Agreement without the prior written consent of the other Party; provided that (i) Illumina may assign or otherwise transfer this Agreement without prior consent to an Affiliate which is capable of performing all of Illumina’s obligations hereunder (including the granting of rights to Licensed IP); provided that (x) Illumina will provide written notice to CareDx of the same, and (y) the assignee agrees in writing to be bound by the terms and conditions of this Agreement, and (ii) CareDx may assign or otherwise transfer this Agreement without prior consent to an acquirer of all or substantially all of CareDx’s [...***...]. For the avoidance of doubt, upon CareDx’s assignment of this Agreement [...***...], [...***...], Illumina may [...***...].

 

(b) Any purported assignment or other transfer of this Agreement (in whole or in part) in violation of this Section 14.5 will be null and void.  

 

(c) Subject to this Section 14.5, this Agreement will be binding upon and inure to the benefit of each of the Parties and their permitted successors and assigns.  

 

1.1

28

* Confidential Treatment Requested

 


 

14.6 Export .  Notwithstanding anything to the contrary in this Agreement, each Party and its agents and distributors may not disclose, export or re-export, directly or indirectly, any Licensed Products , Supplied Products, embodiments of Licensed IP or any related software, technology or know-how relating to this Agreement to any country or party which is ineligible to receive such items under law (including regulations of the U.S. Department of Commerce and the U.S. Department of the Treasury).  

 

14.7 Notices .  All notices required or permitted under this Agreement will be in writing, in English, and will be deemed received only when: (i) delivered personally; or (ii) one day after deposit with a commercial express courier specifying next day delivery or, for international courier packages, two days after deposit with a commercial express courier specifying two-day delivery, with written verification of receipt.  All notices will be sent to the following or any other address designated by a Party using the procedures set forth in this Section 14.7:

 

If to Illumina:

 

Illumina, Inc.

[...***...]

Attn: General Counsel

 

With a copy to: [...***...]

If to CareDx:

 

CareDx, Inc.

[...***...]

Attn: Chief Executive Officer

 

With a copy to: Paul Hastings LLP

[...***...]

 

Attn: Jeff Hartlin and Matthew Berger

 

14.8 Force Majeure . Neither Party will be in breach of this Agreement nor liable for any failure to perform or delay in the performance of this Agreement attributable in whole or in part to any cause beyond its reasonable control, including any change in applicable law or interpretation thereof (each an event of “ Force Majeure ”).  In the event of any such delay the delivery date for performance will be deferred for a period equal to the time lost by reason of the delay.  Notwithstanding anything in this Agreement to the contrary, neither Party’s payment obligations shall be affected by this provision except to the extent the Force Majeure affects financial institutions and, as a result, the financial institutions cannot complete the transaction necessary for the applicable Party to satisfy its payment obligations.

 

14.9 Application of the Code .

 

(a) The Parties agree that all rights and licenses granted to CareDx under this Agreement are rights and licenses to "intellectual property" as defined in Section 101(35A) (or its successors) of Title 11 of the United States Bankruptcy Code or its successor (“ Code ”). CareDx will, during the Term of the Agreement, have the rights set forth in this Agreement with respect to the Licensed IP of Illumina, when and as such Licensed IP of Illumina is developed or created by or for Illumina. In addition and without limitation to the foregoing, Illumina acknowledges and agrees that CareDx, as a licensee of Illumina’s Intellectual Property under this Agreement, will have and may fully exercise all rights available to it under the Code, including under Section 365(n) of the Code. In the event Illumina files for protection under the Code and the trustee for Illumina rejects this Agreement and, pursuant to Section 365(n) of

29


 

the Code, CareDx elects to retain its rights under this Agreement as described in Section 365(n)(1)(B) of the Code , not in lieu or limitation of any other rights or remedies available to CareDx, Illumina or the trustee for Illumina or its assets will, at CareDx's written request, deliver to CareDx any Licensed IP of Illumina license d to CareDx under this Agreement that Illumina is obligated to deliver or transfer to CareDx pursuant to Section 8.1 but that has not yet been delivered or transferred to CareDx in accordance with Section 8.1 .

 

(b) The Parties agree that all rights and licenses granted to Illumina under this Agreement are rights and licenses to “intellectual property” as defined in Section 101(35A) (or its successors) of the Code. Illumina will, during the Term of the Agreement, have the rights set forth in this Agreement with respect to the Improvements of CareDx, when and as such Improvements of CareDx are developed or created by or for CareDx. In addition and without limitation to the foregoing, CareDx acknowledges and agrees that Illumina, as a licensee of CareDx’s Intellectual Property under this Agreement, will have and may fully exercise all rights available to it under the Code, including under Section 365(n) of the Code. In the event CareDx files for protection under the Code and the trustee for CareDx rejects this Agreement and, pursuant to Section 365(n) of the Code, Illumina elects to retain its rights under this Agreement as described in Section 365(n)(1)(B) of the Code, not in lieu or limitation of any other rights or remedies available to Illumina, CareDx or the trustee for CareDx or its assets will, at Illumina’s written request, notify and provide to Illumina any Improvements of CareDx licensed to Illumina under this Agreement that CareDx is obligated to notify and provide to Illumina pursuant to Section 3.1 but that has not yet been provided to Illumina in accordance with Section 3.1.

 

14.10 Entire Agreement; Amendment .  This Agreement and a related Transition Services Agreement entered into by the Parties after the Effective Date, together with the exhibits hereto and thereto, represent the entire agreement between the Parties regarding the subject matter hereof and supersede all prior discussions, communications, agreements, and understandings of any kind and nature between the Parties.  The Parties acknowledge and agree that by entering into this Agreement, they do not rely on any statement, representation, assurance or warranty of any Person other than as expressly set forth in this Agreement or the above-referenced Transition Services Agreement.  Each Party agrees that it will have no right or remedy (other than for breach of contract) in respect of any statement, representation, assurance or warranty (whether made negligently or innocently) other than as expressly set forth in this Agreement or the above-referenced Transition Services Agreement.  Nothing in this Section 14.10 will exclude or limit any liability for fraud.  No amendment to this Agreement will be effective unless in writing and signed by both Parties.

 

14.11 Relationship of the Parties .  The Parties are independent contractors under this Agreement and nothing in this Agreement may be construed as creating a partnership, joint venture or agency relationship between the Parties, or as granting either Party the authority to bind or contract any obligation in the name of the other Party or to make any statements, representations, warranties or commitments on behalf of the other Party.

 

14.12 Headings; Interpretation; Miscellaneous .  Sections, titles and headings in this Agreement are for convenience only and are not intended to affect the meaning or interpretation of this Agreement.  Whenever required by the context, the singular term includes the plural, the plural term includes the singular, and the gender of any pronoun includes all genders.  As used in this Agreement, except as the context may otherwise require, the words “include,” “includes,” “including,” and “such as” are deemed to be followed by “without limitation” or “but not limited to,” whether or not they are in fact followed by such words or words of like import, and “will” and “shall” are used synonymously.  Except as expressly

30


 

stated, any reference to “days” will be to calendar days, and “business day” means all days other than Saturdays, Sundays, or a national or local holiday recognized in the United States, any reference to “calendar month” will be to the month and not a 30 day period, and any reference to a “quarter” will mean the relevant three month period based upon the Contract Y ear .  Whenever the last day for the exercise of any right or the discharge of any obligation hereunder falls on, or any notice is deemed to be given on, a Saturday, Sunday or national or local holiday recognized in the United States, the Party having such right or obligation will have until 5:00 pm PT on the next succeeding business day to exercise such right or to discharge such obligation or the Party giving notice will be deemed to have given notice on the next succeeding business day.  No usage of trade, course of performance, or other regular practice between the Parties may be used to interpret or alter the terms or conditions of this Agreement.  Unless otherwise expressly provided in this Agreement, any agreement, instrument or statute defined or referred to means such agreement, instrument or statute as from time to time amended, modified, or supplemented, including (in the case of agreements or instruments) by waiver or consent and (in the case of statutes) by succession of comparable successor statutes and references to all attachments thereto and instruments incorporated therein.  The Parties have participated jointly in the negotiation and drafting of this Agreement.  If an ambiguity or question of intent or interpretation arises, this Agreement will be construed as if drafted jointly by the Parties, and no presumption or burden of proof will arise favoring or disfavoring any Party because of the authorship of any provision of this Agreement.  

 

14.13 Counterparts .  This Agreement may be executed in one or more counterparts, each of which will be deemed to be an original, and all of which will constitute one and the same instrument.

 

14.14 Costs . Except as expressly provided in this Agreement, each Party will pay its own costs incurred in connection with the negotiation, preparation, and execution of this Agreement and any documents referred to in this Agreement.

 

[SIGNATURE PAGE FOLLOWS.]


 


 

 

Signature Page to

license and commercialization Agreement

 

IN WITNESS WHEREOF, the Parties have executed this Agreement effective as of the Effective Date.

 

 

Illumina

 

Illumina, Inc.

 

 

By: /s/ Jonathan Seaton

 

Name: Jonathan Seaton

 

Title: SVP Corporate & Business Development

 

Date: 4 May 2018

 

 

CareDx

 

CareDx, Inc.

 

 

By: /s/ Peter Maag

 

Name: Peter Maag

 

Title: President & CEO

 

Date:_ May 4, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[Signature Page to License and Commercialization Agreement]


 

 


 

EXHIBIT A

LICENSED FIELD SPECIFIC PATENTS

 

[...***...]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

* Confidential Treatment Requested

 


 

EXHIBIT B

 

Illumina HLA Existing Product Pricing

 

Catalogue Number

Description

Kit Size

Base Price (USD)*

Discount off Base Price

Standard Lead Time**

FC-142-1001

TruSight HLA Seq Panel (24 smp)

24 samples

$[...***...]

[...***...]%

[...***...]

20006995

TruSight HLA v1 Boxes 3 and 4

192 libraries

$[...***...]

[...***...]%

20010179

TruSight HLA-B Primers v2

96 samples

$[...***...]

[...***...]

20010190

TruSight HLA-DRB Primers v2

96 samples

$[...***...]

[...***...]

20000215

TruSight HLA v2 Seq Panel (24 samples)

24 samples

$[...***...]

[...***...]%

20005170

TruSight HLA v2 (24 samples Automated)

24 samples

$[...***...]

[...***...]%

 

Illumina [ ...***... ] Reagent Pricing

 

[ ...***... ] reagent kits for library preparation that can be used for preparation of up to [ ...***... ] samples including [ ...***... ] [ ...***... ] (for which a part number will be provided prior to sale to CareDx when available):

 

Number of Such Products Purchased in Prior Calendar Year

Base Price per Product

Standard Lead Time**

1-625

$[ ...***... ]

[ ...***... ]

626-1,250

$[ ...***... ]

1,251-1,875

$[ ...***... ]

1,876-2,500

$[ ...***... ]

≥ 2,501

$[ ...***... ]

 

[ ...***... ] reagent kits for library preparation in [ ...***... ] only that can be used for preparation of up to [ ...***... ] samples including [ ...***... ] [ ...***... ] (for which a part number will be provided prior to sale to CareDx when available):

 

Number of Such Products Purchased in Prior Calendar Year

Base Price per Product (USD)*

Standard Lead Time**

1-100

$[ ...***... ]

[ ...***... ]

101-250

$[ ...***... ]

251-500

$[ ...***... ]

501-1,000

$[ ...***... ]

≥ 1,001

$[ ...***... ]

 

*Price Adjustments for Supplied Products

 

 

 

* Confidential Treatment Requested

 


 

Illumina reserves all right to adjust base prices of Supplied Products in the usual course of its business, provided that the base prices ( i . e ., the price prior to application of any applicable discounts) under this Agreement shall : (a) not be adjusted more than once per calendar year and (b) (i) such annual adjustment shall not increase the base price by more than [ ...***... ] % during any calendar year and shall not, in any event, be a higher percentage price increase than substantially all of Illumina’s other customers for the same Supplied Product .  Any adjusted base prices will be reflected in the quotation provided for sale of the products being purchased.

 

** Standard Lead Times listed in the table above assume that the order for Supplied Products materially complies with the terms and conditions of this Agreement and is within [ ...***... ] of the applicable forecast.  If the order is outside of such range, the Lead Time may exceed those listed in the table above.

 

Development, Validation and Verification Kits . One time each quarter during the Term, CareDx may purchase Supplied Products that shall only be used for CareDx’s internal development, validation, and verification of Licensed Products.  Such Supplied Products will be sold to CareDx at a discount of [ ...***... ]% off of the base price in this Agreement, and the quarterly purchase shall not exceed [ ...***... ]% of the quantity of such Supplied Products forecasted (on a Supplied Product-by-Supplied Product basis) in accordance with Exhibit B for the applicable quarter. The Parties acknowledge and agree that any Supplied Products purchased under this provision for development, validation or verification cannot be re-Sold without Illumina’s prior written approval.

 

Additional Terms and Conditions for Supplied Products

 

(a) Software .  All software, whether provided separately, installed on, or embedded in a Supplied Product, is licensed not sold.  

 

(b) Forecasts .  CareDx shall, no later than the first day of each month during the Contract Year, provide Illumina with a non-binding forecast representing CareDx’s good faith estimate of the amount of Supplied Products that CareDx expects to purchase from Illumina on a monthly basis during the Contract Year.  The first two months of each such forecast shall represent a binding commitment by CareDx to purchase and Illumina to supply such amounts of Supplied Products in accordance with this Agreement.

 

(c) Purchase Orders .  CareDx, the United States entity, shall order Supplied Products from Illumina, the United States entity, under this Agreement using written purchase orders.  Purchase orders shall state, at a minimum, the Illumina catalogue or part number, the Illumina-provided quote number (or other reference provided by Illumina), the quantity ordered, price, requested delivery date, and address for delivery.  All purchase orders shall be sent in writing to Illumina Customer Support and be placed with Illumina, the United States entity, and any payment for the shipment of Supplied Products ordered under such purchase orders shall be paid for in US Dollars to Illumina, the United States entity, pursuant to Section 9.6 of this Agreement and subsection (d) below.  Acceptance of a purchase order occurs when Illumina provides a written confirmation of acceptance to CareDx.  Acceptance of a purchase order will be deemed to have occurred absent a confirmation of acceptance or rejection delivered in writing from Illumina to CareDx within 10 business days of Illumina’s receipt of the purchase order. Illumina shall not reject, and shall timely fulfill, any purchase order that meets the following: (i) CareDx has not failed to cure a material breach of the terms and conditions of this Agreement after Illumina has provided written notice of such material breach to CareDx; provided that,

 

* Confidential Treatment Requested

 


 

solely for purposes of this Subsection (c): (x) there is no cure period for any material breach by CareDx of Section s 4.1 or 5.4 of the Agreement or Section 6 of Exhibit C with respect to violation of Anti-Corruption Laws and (y) for all other material breaches, such cure period will be 10 business days from CareDx’s receipt of such written notice (provided that the applicable Lead Time is tolled during such cure period) and (ii) the total monthly amount ordered by CareDx under such purchase order is within [ ...***... ] %- [ ...***... ] % of the forecasted amount of the relevant month in the most recent forecast in which the order is placed and the delivery date is at or outside of the applicable Lead Time .   All purchase orders are non-cancelable and may not be modified without the prior written consent of Illumina ; provided that notwithstanding the foregoing, in the event that CareDx terminates this Agreement pursuant to Section 13.2 then CareDx may elect, at its option, to cancel one or more outstanding purchase orders without penalty or obligation to Illumina .

 

(d) Payment terms .  Illumina shall issue invoices upon shipment of Supplied Products to CareDx.  All payments of undisputed amounts by CareDx on such invoices are due within 30 days after the date of the invoice.  Any payment of an undisputed amount not paid when due may accrue interest at the rate of [...***...] per month, or the maximum amount allowed by law, if lower.  In the event that payment of any undisputed amounts that are due and payable is not made when due, CareDx may request that the Parties promptly meet to discuss and attempt in good faith to discuss the reasons for the lack of payment. Unless otherwise agreed to in writing by the Parties, within 14 days after the commencement of such discussions, Illumina shall have the right to take any action allowed in law and equity for such non-payment of undisputed amounts in addition to any rights under this Agreement, including without limitation, suspend shipment of the Supplied Products until all outstanding undisputed payments are made current.  Each purchase order is a separate, independent transaction under this Agreement, and neither Party has any right of set-off against or transfer to other purchase orders, payments or other transactions with the other.

 

(e) Taxes .  All prices and other amounts payable to Illumina hereunder are exclusive of and are payable without deduction for taxes, GST, VAT, customs duties, tariffs or charges now or hereafter claimed or imposed by any governmental authority upon the sale of the product, all of which will be either (i) added to the purchase price (with no mark-up) upon prior written notice to CareDx, which notice will include the itemized taxes and the corresponding increase in purchase price or (ii) subsequently itemized and invoiced to CareDx.  With respect to New Zealand customers only, CareDx and Illumina agree that subsection 8(4) Goods and Services Tax Act 1985 does not apply.

 

(f) Shipping; Risk of Loss .  Supplied Products shall only be shipped to CareDx’s U.S. location on the purchase order, unless otherwise agreed upon in writing by the Parties.  All shipments will be made under a usual and typical Incoterm (2010) that Illumina specifies (e.g., ExW or DAP), and CareDx is responsible for typical third party freight and insurance costs which will be added to the invoice and paid by CareDx. To the extent the Parties agree to in writing to make any shipments to countries outside of the U.S., CareDx agrees to cover all costs associated with freight and insurance. In addition, if Illumina ships to any CareDx location in any country outside of the U.S. specified on the purchase order where there are import duties, import taxes, or any other importation or customs-related costs incurred, CareDx will be responsible to pay those expenses in full.

 

(g) Inspection; Rejection .  CareDx shall inspect all the Supplied Products for obvious physical damage upon receipt thereof, and shall note any such damage, including on a lot-by-lot basis based on samples from any such lot, on all accompanying shipping and other carrier documents, and CareDx shall notify Illumina of any such damage within 15 days of receipt by CareDx.  Any Supplied Product not rejected

* Confidential Treatment Requested

 

 


 

within the 15-day period shall be deemed accepted.  To reject a Suppl i ed Product, CareDx shall notify Illumina in writing of its rejection and request a Returned Material Authorization (“ RMA ”), and shall comply with Illumina’s repair and return procedures as provided by Illumina to CareDx , as may be amended by Illumina for all ( but a copy of which need only be distributed to all or substantially all ) of its customers from time to time but will be commercially reasonable at all times .  Within 10 days of receipt of the RMA number, CareDx shall return to Illumina the rejected Suppl i ed Product, freight prepaid, in its original shipping carton with the RMA number displayed on the outside of the carton. Illumina reserves the right to refuse to accept any rejected Supplied Products that do not bear an RMA number on the outside of the carton.  Upon receipt by Illumina of properly rejected Supplied Products, Illumina shall, at its option and expense, either repair or replace the returned Supplied Products as promptly as possible given the applicable Lead Times .  Shipment of such repaired or replacement Products to CareDx shall be at Illumina’s expense. For the avoidance of doubt, non-compliance with Illumina’s repair and return procedures will not limit, modify, or condition, or act as a waiver of, Illumina’s obligations under this Subsection (g) unless Illumina provided written notice to CareDx of its non-compliance and CareDx failed to remedy its non-conformance within a reasonable amount of time given the applicable Lead Times . To the extent there is any conflict or inconsistency between this Agreement and the RMA, this Agreement will govern. In addition, a ny acceptance of such Supplied Products will not, and will not be deemed to, waive or affect any rights CareDx may have under the warranties for such Supplied Products or any other rights of CareDx with respect to such Supplied Products under this Agreement or at law or in equity.

 

(h) Warranties .  All warranties are personal to CareDx and may not be transferred or assigned to a third-party, including an Affiliate of CareDx; provided that, the warranty applies to any breach of warranties to any of the Supplied Products, whether such Supplied Products have been sold, re-sold or distributed or otherwise disposed of to third parties; provided that only CareDx shall have the right to enforce the warranties for such Supplied Products. All warranties are facility specific and do not transfer if the Supplied Product is moved to another facility, unless Illumina conducts or supervises such move.  The warranties described in these terms and conditions exclude any stand-alone third party goods that are not provided by Illumina.

 

(i) Warranty for Reagents .  Illumina warrants that reagents (including the [ ...***... ] Reagents but excluding Illumina HLA Existing Products), other than custom reagents, will conform to their written, published technical specifications (in effect on the date that the Supplied Product ships from Illumina) until the later of (x) [ ...***... ] from the date of shipment from Illumina, or (y) any expiration date or the end of the shelf-life pre-printed on such Supplied Product by Illumina, but in either event, no later than [ ...***... ] from the date of shipment.  With respect to custom reagents (i.e., reagents made to specifications or designs made by CareDx or provided to Illumina by, or on behalf of, CareDx), Illumina only warrants that the custom reagents will be made and tested in accordance with Illumina’s standard manufacturing and quality control processes which will be consistent with industry best practices.  Illumina makes no warranty that custom reagents will work as intended by CareDx or for CareDx’s intended uses.

 

(ii) Warranty for Illumina HLA Existing Products . Illumina warrants that from the time of delivery of any Illumina HLA Existing Product to CareDx until the later of: (x) 3 months from the date of shipment from Illumina, or (y) any expiration date or the end of the shelf-life pre-printed on such Illumina HLA Existing Product by Illumina, but in either event, no later than 12 months from the date of shipment, the Illumina HLA Existing Products shall: (1) be free from errors or defects and comply with the Documentation and their specifications; (2) have been manufactured, shipped and stored in

accordance with the Documentation and their specifications, any applicable governmental approvals and

* Confidential Treatment Requested

 

 


 

all applicable laws and regulations; and (3 ) not be adulterated or misbranded under any applicable laws and regulations.

 

(iii) Exclusions from Warranty Coverage .  The foregoing warranty does not apply to the extent a non-conformance after Illumina delivers the Illumina HLA Existing Product to CareDx is due to (i) CareDx’s negligence, (ii) improper storage or use by CareDx except to the extent required or recommended by the Documentation, applicable specifications or product labeling, (iii) improper handling, installation, maintenance, or repair (other than if performed by Illumina’s personnel, contractors or agents and, for the avoidance of doubt, “improper” does not include any handling, installation, maintenance or repair performed to the extent required or recommended by the Documentation, applicable specifications or product labeling), (iv) unauthorized modification by CareDx other than in conformity with the applicable Documentation, specifications or product labeling, or (v) use of the Supplied Product with a third party’s good not supplied by or on behalf of Illumina (unless the Supplied Product’s Documentation, specifications or product labeling expressly states such third party’s good is for use with the Supplied Product).

 

(iv) Procedure for Warranty Coverage . In order to be eligible for repair or replacement under this warranty CareDx must (i) promptly contact Illumina’s support department to report the non-conformance and in any event contact the support department during the applicable warranty period, (ii) reasonably cooperate with Illumina in confirming or diagnosing the non-conformance, and (iii) return the Supplied Product if requested by Illumina, transportation charges prepaid by Illumina following Illumina’s reasonable instructions or, if agreed by Illumina and CareDx, grant Illumina’s authorized repair personnel access to the Supplied Product in order to confirm the non-conformance and make repairs; provided that such authorized repair personnel will comply with all reasonable security, confidentiality, safety and health policies of CareDx applicable to persons present on CareDx’s facilities. In the event of a non-conformance Illumina will be solely responsible for all of its costs and expenses in connection with the repair or replacement.

 

(v) Sole Remedy under Warranty .  Illumina will, at its option, repair or replace non-conforming Supplied Product that is covered by this warranty at its sole cost and expense (including reasonable shipping costs incurred by CareDx for shipping such non-conforming Supplied Product to Illumina).  The warranty period for repaired or replaced reagents or HLA Existing Products is 90 days from the date of shipment, or the remaining period on the original reagent warranty or the applicable warranty for the HLA Existing Products, as applicable and whichever is later. Instruments may be repaired or replaced with functionally equivalent, reconditioned, or new instruments or components.  If the instrument is replaced in its entirety, the warranty period for the replacement is 90 days from the date of shipment or the remaining period on the original instrument warranty, whichever is later.  If only a component is being repaired or replaced, the warranty period for such component is 90 days from the date of shipment or the remaining period on the original instrument warranty, whichever ends later.  Without limiting the generality of Illumina’s indemnification obligations and other obligations under this Agreement, the preceding states CareDx’s sole remedy and Illumina’s sole obligations under the foregoing warranties in this Exhibit B .

 

(i) Regulatory acknowledgement .  CareDx acknowledges that the Supplied Products have not been subjected to regulatory review or approved or cleared by the United States Food and Drug Administration or any other regulatory entity whether foreign or domestic, or otherwise reviewed, cleared or approved under any statute, law, rule or regulation for any purpose, whether research, commercial, diagnostic or otherwise.  The products are labeled For Research Use Only.  Illumina does not

 


 

make any representation, warranty, or covenant that pertains in any way to the regulatory status of the products.   CareDx agrees to use the Supplied P roducts in compliance with all applicable laws and regulations.  


 

 


 

EXHIBIT C

 

CAREDX’S RE-SALE OF ILLUMINA PRODUCTS

 

1.

General .

Scope .  CareDx may only market and Sell Supplied Products for use with the Illumina Sequencing Instruments in the Licensed Field.  The Parties’ activities described in this Agreement shall be at their own cost and expense unless expressly stated otherwise.

 

Customer Agreements .  CareDx shall [...***...] using Customer Agreements and will [...***...] the terms and conditions of such Customer Agreements; provided that notwithstanding the foregoing, CareDx shall have a period of [...***...] to transition any existing customers with whom it already has written agreements to [...***...].  All Customer Agreements [...***...] CareDx must use commercially reasonable efforts to ensure that such standard terms and conditions [...***...].  “ Customer Agreement ” means a [...***...] to such customer. Any Customer Agreement will include, at a minimum, (i) [...***...], (ii) [...***...], and (iii) Illumina’s standard terms and conditions for Research Use Only products (as published on Illumina’s website at the time of Sale).

 

Advertising .  CareDx shall not make any representations, warranties or guarantees with respect to the specifications, features or capabilities of the Supplied Products that are not consistent with Illumina’s then-current Documentation, published specifications or product labeling for or literature describing the Supplied Products, including without limitation the limited warranty and disclaimers, as well as Illumina’s Ad/Promo Guidelines, a copy of which will be promptly provided to CareDx after the Effective Date and thereafter from time to time upon any updates thereto.  CareDx will have in place a mechanism that ensures it uses only Illumina’s most current published materials in any advertising and promotional activities.  

 

Service and Support .  CareDx shall be solely responsible, at its cost, for service and support of Supplied Products.

 

2.

Quality .

Product Complaints .  Each Party shall promptly investigate, monitor, and report to the other Party (in a reasonable format required by such Party that is provided to the other Party in advance and in writing) any communication from a purchaser (written, electronic, or oral) alleging deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the Supplied Products (“ Complaint(s) ”).  CareDx is responsible for receiving, documenting, and initially investigating any Complaints in the Licensed Field and Illumina is responsible for receiving, documenting and initially investing any Complaints outside of the Licensed Field.  Each Party shall notify the other Party as soon as possible but at least within 2 business days of any Complaints which involve an adverse event or

 

* Confidential Treatment Requested

 


 

potential adverse event (those events which lead, or having the potential to lead, to serious injury or death).  

 

Product Returns .   CareDx shall make reasonable efforts to secure Supplied Product returns as requested by Illumina.  CareDx will perform decontamination of Supplied Product returns, including those it receives without notice.  CareDx will follow any packaging requirements set forth by Illumina.  Returned Supplied Products shall not be re-Sold without Illumina’s prior written approval.  CareDx will provide certificates of destruction for returned Supplied Products that were destroyed under instruction by Illumina.  All product returns will be at Illumina’s sole cost and expense except to the extent that any product return is caused by one or more of the exceptions to the warranty coverage set forth in Section (h)(iii) of Exhibit B .

 

Supplier Corrective Action Request (SCAR) Process .  CareDx may issue Illumina a SCAR if there is a material issue that reasonably warrants a formal SCAR process and response. Illumina shall thereafter use commercially reasonable efforts to promptly: (i) investigate and respond to SCAR within thirty (30) business days (or as otherwise specified on the SCAR); (ii) develop and undertake corrective/preventive action plans as warranted; and (iii) implement such action(s) within a mutually agreed-upon timeframe appropriate to the specific SCAR at Illumina’s sole cost and expense. SCARs are not intended to resolve normal business relationship issues.

 

Advisory Notices (Product Recall, Correction or Removal) .  Illumina shall have responsibility and final authority for initiating Product Advisory Notices and Product Quality Notifications (or similar communications) for Supplied Products. Both Parties shall reasonably cooperate in the handling and disposition of such actions.  CareDx shall carry out commercially reasonable activities as defined in written instructions from Illumina, including without limitation distribution of field safety notices. If CareDx is required by law to report participation in advisory notices to local authorities, it will inform Illumina in writing when it does so via email at RA@illumina.com .  In the event Illumina becomes aware of issues that may adversely affect the performance of safety of Supplied Products, Illumina shall use commercially reasonable efforts to promptly provide to CareDx a Product Quality Notification addressing such issues, and instructions concerning Supplied Product disposition.  CareDx shall use commercially reasonable efforts to execute disposition instructions.  Should CareDx be required to provide the Product Quality Notification to Qualified Entities, it will do so without translation unless obliged to by local law.  CareDx must create and maintain records of its actions performed in support of advisory notices.

 

Product Traceability .  CareDx shall establish a “customer by product” and “product by customer” tracking system to maintain direct traceability from CareDx to the customer (at product, lot/serial number, quantity, and shipment date levels, at a minimum).

 

Product Labeling; Branding; Related Documentation .  CareDx shall not make changes to Supplied Product labeling, instructions, promotional materials, or similar materials, without prior written approval from Illumina.  If translations are necessary, CareDx shall use qualified suppliers approved by Illumina in writing and provide Certificates of Translation to Illumina upon request.  

 

Controls, Product Storage, and Handling .  CareDx shall use appropriate packaging material and employ appropriate controls to control, store and handle products in accordance with the applicable specifications (including but not limited to storing Products at the specified temperatures) during

41


 

storage, handling, and transportation to the customer .   CareDx shall also employ appropriate controls to avoid Supplied Product mix-ups.   

 

Nonconforming Materials .  Upon notification from Illumina, CareDx will take action to contain potentially nonconforming materials pending further instruction from Illumina.  All affected materials shall be segregated and quarantined, physically and in any inventory management system used by CareDx, until instructions concerning its disposition are provided by Illumina in writing.  In the event that CareDx identifies a nonconformance that may impact a Supplied Product, CareDx will contain any potentially impacted materials and obtain material disposition approval in writing from Illumina prior to releasing the Supplied Product.  CareDx and Illumina will reasonably cooperate in performing investigations or needed corrections and/or corrective actions with respect to the material. The costs of such segregation and quarantine will be at Illumina’s sole cost and expense (after prior written approval of such costs is obtained from Illumina which upon, such approval, CareDx will perform its obligations under this section) except to the extent that any non-conformance is caused by one or more of the exceptions to the warranty coverage set forth in Section (h)(iii) of Exhibit B .

 

Control of Changes . CareDx shall promptly notify Illumina, via email at [...***...], of any significant changes that may reasonably impact its business involving Supplied Products.  The notice shall include specifics about the change, how the change arose, and the anticipated impact to the Supplied Product or business. CareDx will reasonably cooperate with Illumina by providing requested information related to the change as soon reasonably practicable.  Events subject to notice under this provision include, but are not limited to:

(i) changes in CareDx’s corporate status, organization, ownership, and similar matters; and

(ii) changes in key personnel.

In addition to and not in lieu or limitation of the foregoing, each Party shall promptly notify the other Party (in the case of CareDx to Illumina, via email at [...***...]) of any changes to the facility or processes used to manufacture, store or support the Supplied Products, including without limitation significant or material changes to facilities, additions of new locations, significant or material changes to processes with respect to the Supplied Products and changes to the status of ISO certifications.

 

3.

Regulatory .

 

Regulatory Inspections .  Each Party shall permit any regulatory authority to inspect its premises for compliance with the terms and conditions of this Agreement, and applicable law.  To the extent permitted by applicable law, CareDx shall promptly inform Illumina by e-mail at [...***...] and Illumina shall promptly inform CareDx by e-mail at regulatory@caredx.com, as applicable, in either case, of any regulatory inspections that may involve the Supplied Product(s) and permit representatives from the other Party to be present during the inspection.  To the extent possible, CareDx will consult with Illumina in good faith and provide Illumina with the opportunity to provide input and comments prior to making any commitment to a regulatory agency regarding the Supplied Product(s), to the extent that the foregoing does not jeopardize CareDx’s obligations under applicable law.  Additionally, each Party will promptly inform the other Party upon receipt of any regulatory correspondence or actions regarding the Supplied Product(s) and promptly provide the other Party with a copy of any such regulatory correspondence (which may be redacted for confidentiality purposes).

 

Regulatory Approvals and Product Registration .  CareDx shall obtain or process (as applicable) any and all permits, listings, licenses, registrations, approvals or other similar documentation required by a government, or any other administrative agency or otherwise, to Sell the Supplied Products in the

 


 

corresponding countries (together referred to as the Approval(s) ”).  CareDx will pay any costs and fees associated with obtaining and maintaining any required licenses, permits, registrations or approvals related to Supplied Products. Notwithstanding the foregoing, Illumina will promptly provide (and cause its Affiliates to promptly provide): (a) any data, information or other materials relating to the Supplied Products that it owns or controls or can access and make available to CareDx using commercially reasonable efforts and (b) any filing or correspondence that Illumina had with any government or any other administrative agency in connection with the Supplied Product, in each of the foregoing cases, to the extent necessary for CareDx, or used by Ill umina or any of its Affiliates, to obtain Approvals.   CareDx may modify the labelling of an Illumina [ ...***... ] Product solely as necessary to obtain an Approval provided that in such a case CareDx will give a reasonable amount of prior written notice to Illumina and will give good faith consideration of any reasonable concerns from Illumina.   Illumina hereby grants CareDx the right to access and use any of such foregoing data, information, materials, filing or correspondence to the extent necessary for, or used by Illumina or any of its Affiliates, to support the Approvals, including the right to cross-reference, file or incorporate any of the foregoing.   CareDx will give Illumina a copy of such submission to obtain Approvals at least 30 days prior to use and will consider in good faith a ny reasonable comment by Illumina on any such submission (provided that any edits from Illumina intended to for reasons relating to confidentiality or protection of its Intellectual Property rights must be implemented) . Upon termination or expiration of this Agreement, CareDx shall initiate, within 10 business days, the transfer of ownership of any required Approval related to any Supplied Product. If, upon termination or expiration of this Agreement, CareDx fails to transfer and assign any Approvals to Illumina or its third Party designate, CareDx shall be deemed to have appointed Illumina as its Attorney with a full Power of Attorney to execute any such transfer or assignment of an Approval on CareDx’s behalf.  At no time during the term of this Agreement or thereafter shall CareDx take any action that would result in the cancellation, revocation, annulment or rescission (or similar action) of any existing or future Approval for Supplied Products, unless directed in writing by an authorized representative of Illumina.  

 

Labeling .  CareDx shall not modify Illumina’s labeling (including logos), private label or co-label the Supplied Products without the prior written consent of Illumina or unless otherwise expressly permitted under this Agreement.  

 

Export and Import Licenses .  Illumina will, at its own cost, obtain any and all permits, approvals and licenses required for its export of the Supplied Products from the point of manufacture/distribution, and CareDx will, at its own cost, obtain any and all permits, approvals and licenses required for its importation of the Supplied Products.

 

4.

Competitive Pricing .  CareDx agrees, to the extent permitted by applicable law, that it will not to re-Sell, or permit its distributors or agents to Sell or re-Sell, Illumina HLA Existing Products at a local currency equivalent more than [...***...] for the corresponding Illumina HLA Existing Product.

 

5.

Sales and Marketing .

Materials .    Illumina shall provide CareDx with access to electronic versions of existing marketing, sales and/or technical information, regardless of the form or media in which distributed (e.g., paper, audio, video, electronic, internet) concerning the Illumina HLA Existing Products which Illumina deems appropriate for the promotion, distribution, and sale of such products.  Information and claims within the technical, sales, and marketing materials provided by Illumina may not be modified or supplemented without Illumina’s prior written approval.

 

* Confidential Treatment Requested

 

 


 

 

Guidelines .  In all cases and at all times, CareDx will follow Illumina’s Ad/Promo Guidelines and Trademark Policies and Usage Guidelines, a copy of which will be promptly provided to CareDx after the Effective Date and thereafter from time to time upon any updates thereto.  Illumina reserves the right to update these guidelines at any time and any such updates shall be binding on CareDx within a reasonable period of time following receipt by CareDx of the updated guideline.

 

Expenses .  All expenses incurred by CareDx with respect to creating advertising materials and advertising the Supplied Products, including materials ordered from Illumina, shall be CareDx’s responsibility.  CareDx represents and warrants that all documentation related to the Supplied Products made by or for CareDx (and, for the avoidance of doubt, not made or provided by or for Illumina or any of its Affiliates) shall be accurate and shall be made in a professional manner.  

 

Copies to Illumina .  CareDx, promptly upon disseminating any marketing materials relating to the Supplied Products, shall provide Illumina with a complete copy of the disseminated marketing materials except if such marketing materials are made or provided by or for Illumina or any of its Affiliates.  If Illumina reasonably objects to or comments on any such marketing materials in good faith, CareDx shall promptly implement any Illumina-requested changes or corrections to such marketing materials or, if requested by Illumina, will promptly withdraw such materials from public circulation; provided that the foregoing will not require CareDx or any of its Affiliates to jeopardize their compliance with applicable law.

 

6.

Miscellaneous .

Sole source .  If requested by Illumina, the Parties will discuss any commercially reasonable ways to minimize any negative impact caused by CareDx’s activities on Illumina’s ability to represent to other purchasers of its products that Illumina is the sole source of such products.

 

Security Interest .  To the extent applicable under local law, CareDx hereby grants Illumina and its Affiliates a purchase money security interest or right of repossession in each Illumina HLA Existing Products Sold under this Agreement.  If CareDx Sells any such Illumina HLA Existing Products to another party prior to CareDx’s paying the full amount of CareDx’ purchase price for such Supplied Product, then the security interest shall cover the proceeds from such Sale.  These interests shall be satisfied by payment in full of CareDx’s purchase price.  Illumina or its Affiliate may file a financing statement or the equivalent for such security interest and CareDx shall sign any such statements or other documentation necessary to perfect Illumina or its Affiliate’s security interest.

 

Anti-Bribery and Anti-Corruption Laws; Code of Ethics .  In conformity with the United States Foreign Corrupt Practices Act and the UK Bribery Act, any local anti-competition and anti-bribery laws (together, “ Anti-Corruption Laws ”), in each case, to the extent applicable, CareDx shall not directly or indirectly make an offer, payment, promise to pay, or authorize payment, or offer a gift, promise to give, or authorize the giving of anything of value for the purpose of influencing an act or decision of an official of any government (including a decision not to act) or inducing such a person to use his influence to affect any such governmental act or decision in order to assist CareDx, its distributors and agents, or Illumina in obtaining, retaining or directing any such business or any other third party, with the intent to influence an act or decision of that third party in order to assist CareDx or Illumina in obtaining, or retaining or directing any such business.  CareDx shall ensure that its employees and agents, and employees and agents of its distributors and agents are advised of their obligations under the Anti-Corruption Laws, and shall provide a list of all distributors and agents if requested and certification that

 


 

adequate due diligence has been performed to ensure compliance with Anti-Corruption Laws, embargo restrictions, prohibited and excluded persons requirements, and all regulatory requirements.  CareDx’s efforts in this regard shall include, at a minimum, requiring its employees and agents who are conducting activities outside the United States to complete Illumina’s distributor Anti-Corruption Laws training program no later than 60 days after the Effective Date and ens uring that all Anti-Corruption Law t raining provided by Illumina shall be disseminated and certified to all sub-agents, dealers, and distributors and shall have in place appropriate controls to ensure adherence to such trainings, such as monitoring and auditing.  Upon Illumina’s request, CareDx shall provide to Illumina written confirmation that its applicable employees and agents have conducted such training and any subsequent requi red training provided to CareDx from Illumina including certification that such training was completed within 60 days of receipt. In addition, Illumina is committed to conducting its business with the highest degree of ethics and honesty, as described in more detail in Il lumina’s Code of Ethics , as provided in advance and in writing to CareDx .  CareDx shall not receive inappropriate gifts, payments or other compensation, and shall report relationships or transactions that could be reasonably expected to give rise to a conflict of interest. CareDx shall ensure that it keeps all accurate books and records in accordance with the Anti-Corruption Law s . No payments shall be made in cash or from any sources that are off the books, or through any indirect sources not recorded accurately in the fina ncials of CareDx . CareDx shall make available all records, transactions, and employees to Illumina to the extent reasonably necessary for Illumina to perform routine audits on CareDx’s compliance with this Section in a timely manner upon notification from Illumina.   If a violation is found, CareDx shall inform Illumina’s Legal department within 24 hours of knowledge of the violation and shall terminate any relationship with sub-agents, distributors, or dealers if such violations are substantiated.

 


 

 


 

EXHIBIT D

 

KNOWLEDGE TRANSFER

 

[ ...***...]

 


* Confidential Treatment Requested

 

 


 

EXHIBIT E

 

OUTLINE OF TRANSITION SERVICES

 

 

SERVICES

Subject Matter*

Illumina Employee**

Service Commitment***

Illumina Chimerism Formulation and assay

[...***...]

[...***...]% FTE for [...***...] after Transition Effective Date

Illumina Chimerism Software

[...***...]

[...***...]% FTE for [...***...] after Transition Effective Date + [...***...]% FTE for [...***...] after Transition Effective Date

Bioinformatics algorithm in Illumina Chimerism Software

[...***...]

[...***...] sessions to answer specific questions provided in advance

Illumina HLA Existing Software

[...***...]

[...***...]% FTE for [...***...] after Transition Effective Date + [...***...]% FTE for [...***...] after Transition Effective Date

Illumina HLA Existing Product assay training

[...***...]

[...***...] training workshop

Illumina HLA v3 Primer design

[...***...]

[...***...]% FTE for [...***...] after Transition Effective Date + [...***...]% FTE for [...***...] after Transition Effective Date

Transition Manager

[...***...]

[...***...]% FTE for [...***...] after Transition Effective Date + [...***...]% FTE for [...***...] after Transition Effective Date + [...***...]% FTE for [...***...] after Transition Effective Date

 

* “Transition Effective Date” means the earlier of a date of CareDx’s choosing and the date that Knowledge Transfer relating to the relevant transition service under Section 8.1 is complete (e.g., for [...***...], the date of completion of transfer of the Illumina Chimerism Software contents in Exhibit D). Capitalized terms used in this column otherwise have the meaning given in this Agreement.

 

** If an Illumina employee who is designated in the table above to provide a transition service terminates his or her employment with Illumina or changes the functional area of their employment such that it is no longer applicable, or if Illumina terminates such Illumina employee for good cause or changes the functional area of employment for good reason such that it is no longer applicable, Illumina shall not be obligated to provide such transition service. Notwithstanding the foregoing, in the case where an Illumina employee or Illumina changes the functional area of such employee’s employment, Illumina will use good faith efforts to find a suitable replacement for such employee.

 

 

* Confidential Treatment Requested

 


 

*** Transition s ervices will be provided telephonically or via email unless otherwise agreed to by the Parties (in which case reimbursement of expenses as agreed upon by the Parties may be required).  

 

The Transition Manager shall be CareDx’s point of contact and all communications relating to the Services should be made through the Transition Manager unless otherwise agreed to by the Transition Manager.

 

 


 

EXHIBIT F

 

TRANSITION MATTERS RELATED TO ILLUMINA HLA EXISTING PRODUCTS

1.

Ongoing sales commitments agreed to by Illumina prior to the Effective Date.

 

Tenders .  Illumina has participated in the following tenders involving Illumina HLA Existing Products:

 

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

  

Standing Orders, Quotes, or Other Supply Commitments .  Illumina has accepted (i) standing orders for Illumina HLA Existing Products to be shipped after the Effective Date, or (ii) otherwise agreed to supply customers with Illumina HLA Existing Products after the Effective Date, for the following customers (or their Affiliates):

 

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

 

In addition, any orders received under a quote issued by Illumina or its Affiliate prior to June 1, 2018 shall be included in this subsection 1 of Exhibit F and will be governed by this Exhibit F.

 

Reagent Rental . Illumina has existing rights and obligations with respect to the following reagent rental agreements involving Illumina HLA Existing Products:

 

[...***...]

[...***...]

[...***...]

 

2. Transition Process. Within five (5) days after the Effective Date, Illumina and CareDx shall issue a joint communication to [...***...] of Illumina HLA Existing Products, including each customer set forth in Section 1 of this Exhibit F . Such joint communication shall inform the applicable customer that Illumina and CareDx have entered into an agreement under which CareDx will

* Confidential Treatment Requested

 

 


 

Sell Illumina HLA Existing Products to customers worldwide. The Parties acknowledge that [ ...***... ] will need to be obtained for the transfer to CareDx of existing agreements and obligations requiring Illumina to supply Illumina HLA Existing Products to customer , which shall primarily be the responsibility of [ ...***... ] unless otherwise stated by Illumina . Illumina will assign an employee to be CareDx’s main point of contact as the Transition Manager to assist with transition of customers and existing sales and support obligations.  As of the Effective Date, the Transition Manager is [ ...***... ] .   In the event a [ ...***... ] , the Parties agree that notwithstanding anything in this Agreement to the contrary, Illumina shall have the right to Sell Illumina HLA Existing Products to such customer, to the extent Illumina is contractually required to do so in its documentation in effect at the Effective Date with such customer , and Illumina will not renew or otherwise extend the term of such documentation or other agreement with such customer .

 

 

3. Revenues from Sales by Illumina of Illumina HLA Existing Products following the Effective Date. In the event Illumina Sells Illumina HLA Existing Products to a customer following the Effective Date, as set forth in Section 2 of this Exhibit F , Illumina shall pass along to CareDx [...***...]% of the revenue from such Sale, and CareDx shall be entitled to credit [...***...] such revenue from such Sale against its minimum purchase obligations in Section 9.2.

 

 

4. Instrument Sales for Reagent Rentals .  If the reagent rental agreements listed in Section 1 of this Exhibit F are transferred to CareDx, as described in Section 2 of this Exhibit F , CareDx shall purchase the instruments subject to such agreements from Illumina at the following discount off list price: [...***...]% for each year that has passed since the instrument was manufactured.

 


 

* Confidential Treatment Requested

 

 


 

EXHIBIT G

 

THIRD PARTY KNOWLEDGE TRANSFER COMPONENTS

 

[...***...]

 

 


 

* Confidential Treatment Requested

 

 


 

EXHIBIT H

 

[...***...]

[...***...]

 

 

 

* Confidential Treatment Requested

 

 

Exhibit 31.1

 

CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Peter Maag, certify that:

 

 

1.

I have reviewed this Quarterly Report on Form 10-Q of CareDx, 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(s) 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(s) 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: August 9, 2018

 

By:

 

/s/ Peter Maag

 

 

 

 

Peter Maag

 

 

 

 

President and Chief Executive Officer

 

 

 

 

(Principal Executive Officer)

 

 

Exhibit 31.2

 

CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934,

AS ADOPTED SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Michael Bell, certify that:

 

 

1.

I have reviewed this Quarterly Report on Form 10-Q of CareDx, 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(s) 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(s) 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: August 9, 2018

 

By:

 

/s/ Michael Bell

 

 

 

 

Michael Bell

 

 

 

 

Chief Financial Officer

 

 

 

 

(Principal Accounting and Financial Officer)

 

 

Exhibit 32.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER PURSUANT TO

18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of CareDx, Inc. (the “Company”) for the period ended June 30, 2018 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to their knowledge that:

 

(1)

The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

 

(2)

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

By:

/s/ Peter Maag

 

By:

/s/ Michael Bell

 

Peter Maag

 

 

Michael Bell

 

President and Chief Executive Officer

(Principal Executive Officer)

 

 

Chief Financial Officer

(Principal Accounting and Financial Officer)

 

August 9, 2018

 

 

August 9, 2018

 

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

This certification accompanies the Report, is not deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act (whether made before or after the date of the Report), irrespective of any general incorporation language contained in such filing.