UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended March 31, 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: 001-36086

 

FOUNDATION MEDICINE, INC.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware

27-1316416

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

 

150 Second Street

Cambridge MA

02141

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (617) 418-2200

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  

As of April 27, 2018, the registrant had 37,037,754 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 

 


 

FORWARD LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these words or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

 

our plans or ability to obtain reimbursement coverage and thereafter payment for FoundationOne, FoundationOneHeme, FoundationACT, FoundationFocus CDx BRCA , and FoundationOne CDx, including expectations as to our ability or the amount of time it will take to achieve successful reimbursement coverage and thereafter payment from third-party payors, such as commercial insurance companies and health maintenance organizations, and government insurance programs, such as Medicare and Medicaid;

 

our ability to generate revenue from sales of FoundationOne CDx in light of our receipt of a final National Coverage Determination in March 2018 that establishes nationwide Medicare coverage for FoundationOne CDx for all solid tumor types when ordered by the patient’s treating physician for Medicare beneficiaries with advanced cancer ( i.e. , either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer), who either have not been previously tested using FoundationOne CDx for the same primary diagnosis of cancer or are seeking repeat testing with FoundationOne CDx for a new primary cancer diagnosis, and continue to seek further cancer therapy;

 

the evolving treatment paradigm for cancer, including physicians’ issuance and acceptance of practice guidelines, and the use in clinical practice of molecular information and targeted oncology therapeutics and the market size for molecular information services;

 

physicians’ need for molecular information services and any perceived advantage of our services over those of our competitors, including the ability of our molecular information platform to help physicians treat their patients’ cancers, our first mover advantage in providing comprehensive molecular information services on a commercial scale or the sustainability of our competitive advantages;

 

our ability to generate revenue from sales of services enabled by our molecular information platform to physicians in clinical practice and our biopharmaceutical partners, including our ability to increase adoption of our molecular information services, and to maintain and expand existing or to develop new relationships with biopharmaceutical partners;

 

our plans and ability to develop, receive approval for, and commercialize new services and improvements to our existing services;

 

our ability to increase the commercial success of our molecular information services;

 

the outcome or success of our clinical trials;

 

the ability of our molecular information platform to enhance our biopharmaceutical partners’ ability to develop targeted oncology therapies;

 

our ability to comprehensively assess cancer tissue simultaneously for all known genomic alterations across all known cancer-related genes, including our ability to update our molecular information platform to interrogate new cancer genes and incorporate new targeted oncology therapies and clinical trials;

 

our ability to scale our molecular information platform, including the capacity to process additional tests at high specificity and sensitivity as our volume increases;

 

our ability to capture, aggregate, analyze, or otherwise utilize genomic data in new ways;

 

the acceptance of our publications in peer-reviewed journals or our presentations at scientific and medical conference presentations;

 

our plans and ability to expand our laboratory operations;

 

our relationships with our suppliers from whom we obtain laboratory reagents, equipment, or other materials which we use in our molecular information platform, some of which are sole source arrangements;

 

anticipated increases in our sales and marketing costs due to expansions in our sales force and marketing activities within and outside of the United States;

2


 

 

our ability to operate outside of the United States in compliance with evolving legal and regulatory requirements;

 

our ability to meet future anticipated demand by making additional investments in personnel, infrastructure, and systems to scale our laboratory operations;

 

federal, state, and foreign regulatory requirements, including potential United States Food and Drug Administration, or FDA, regulation of our molecular information services or future services;

 

our plans to seek approval from the FDA or other regulatory authorities for certain of our services or future services, as well as our ability to secure such approvals;

 

our ability to protect and enforce our intellectual property rights, including our trade secret protected proprietary rights in our molecular information platform;

 

our anticipated cash needs and our estimates regarding our capital requirements and our needs for additional financing, as well as our ability to obtain such additional financing on reasonable terms;

 

our ability to recognize the benefits of our broad strategic collaboration with affiliates of Roche Holdings, Inc. and Roche’s ability to successfully market and sell our services outside of the United States;

 

our ability to borrow all available amounts under our credit facility with Roche Finance Ltd, and our ability to comply with our covenants and other obligations contained in the credit agreement;

 

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

 

other factors discussed elsewhere in this Quarterly Report on Form 10-Q.

Any forward-looking statements in this Quarterly Report on Form 10-Q reflect our current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under Part II, Item 1A. “Risk Factors” in this Quarterly Report and our prior filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

Unless the context requires otherwise, references in this Quarterly Report to “we,” “us”, “our” and “Foundation” refer to Foundation Medicine, Inc. and our subsidiaries. We own various U.S. federal trademark registrations and applications, and unregistered trademarks and service marks. Foundation Medicine®, FoundationOne®, FoundationACT®, Interactive Cancer Explorer®, FoundationICE®, GeneKit®, Once. And for All®, and The Molecular Information Company® are all registered trademarks of Foundation Medicine in the United States, and several of these marks are at various stages of the registration process in other countries. FoundationOne CDx™, FoundationFocus™, FoundationCORE™, PatientMatch™, Precision Medicine Exchange Consortium™, SmartTrials™, and FoundationACCESS™ are also trademarks of Foundation Medicine. Other trademarks or service marks that may appear in this Quarterly Report are the property of their respective holders. For convenience, we do not use the ® and ™ symbols in each instance in which one of our trademarks appears throughout this Quarterly Report, but this should not be construed as any indication that we will not assert, to the fullest extent under applicable law, our rights thereto.

 

3


 

FOUNDATION MEDICINE, INC.

REPORT ON FORM 10-Q

For the Quarterly Period Ended March 31, 2018

 

 

 

 

 

PAGE

PART I. FINANCIAL INFORMATION

 

 

Item 1.

 

Financial Statements (unaudited)

 

 

a)

 

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

 

5

b)

 

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three Months Ended March 31, 2018 and 2017

 

6

c)

 

Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2018 and 2017

 

7

d)

 

Notes to Condensed Consolidated Financial Statements

 

8

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

26

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

37

Item 4.

 

Controls and Procedures

 

37

PART II. OTHER INFORMATION

 

38

Item 1.

 

Legal Proceedings

 

38

Item 1A.

 

Risk Factors

 

38

Item 6.

 

Exhibits

 

46

SIGNATURES

 

48

 

 

4


 

FOUNDATION MEDICINE, INC.

Condensed Consolidated Balance Sheets

(unaudited)

(In thousands, except share and per share data)

 

 

March 31,

 

 

December 31,

 

 

 

2018

 

 

2017

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

60,293

 

 

$

71,404

 

Accounts receivable

 

 

32,222

 

 

 

19,967

 

Receivable due from Roche

 

 

9,099

 

 

 

10,159

 

Inventory

 

 

16,411

 

 

 

13,171

 

Prepaid expenses and other current assets

 

 

13,003

 

 

 

9,118

 

Total current assets

 

 

131,028

 

 

 

123,819

 

Property and equipment, net

 

 

41,607

 

 

 

41,119

 

Restricted cash

 

 

2,305

 

 

 

2,305

 

Other assets

 

 

2,225

 

 

 

1,760

 

Total assets

 

$

177,165

 

 

$

169,003

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

25,865

 

 

$

21,926

 

Accrued expenses and other current liabilities

 

 

22,393

 

 

 

36,745

 

Deferred revenue

 

 

2,867

 

 

 

2,212

 

Roche related-party deferred revenue

 

 

4,801

 

 

 

3,742

 

Current portion of deferred rent

 

 

1,836

 

 

 

1,818

 

Total current liabilities

 

 

57,762

 

 

 

66,443

 

Deferred rent, net of current portion and other non-current liabilities

 

 

10,507

 

 

 

10,892

 

Indebtedness to Roche - non-current

 

 

90,000

 

 

 

60,000

 

Commitments and contingencies (Note 15)

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Common stock, $0.0001 par value, 150,000,000 shares authorized; 36,933,569 and

   36,541,770 shares issued and outstanding at March 31, 2018 and December 31,

   2017, respectively

 

 

4

 

 

 

4

 

Additional paid-in capital

 

 

544,541

 

 

 

537,904

 

Accumulated other comprehensive income (loss)

 

 

(177

)

 

 

109

 

Accumulated deficit

 

 

(525,472

)

 

 

(506,349

)

Total stockholders’ equity

 

 

18,896

 

 

 

31,668

 

Total liabilities and stockholders’ equity

 

$

177,165

 

 

$

169,003

 

 

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

 

5


 

FOUNDATION MEDICINE, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(unaudited)

(In thousands, except share and per share data)

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2018

 

 

2017

 

Revenue:

 

 

 

 

 

 

 

 

Molecular information services

 

$

31,943

 

 

$

15,594

 

Related-party molecular information services from Roche

 

 

14,648

 

 

 

5,504

 

Pharma research and development services

 

 

4,782

 

 

 

1,087

 

Related-party pharma research and development services from Roche

 

 

1,467

 

 

 

4,143

 

Total revenue

 

 

52,840

 

 

 

26,328

 

Costs and expenses:

 

 

 

 

 

 

 

 

Cost of molecular information services

 

 

21,279

 

 

 

17,117

 

Cost of related-party molecular information services from Roche

 

 

5,948

 

 

 

900

 

Selling and marketing

 

 

17,480

 

 

 

16,436

 

General and administrative

 

 

20,695

 

 

 

15,277

 

Research and development

 

 

23,859

 

 

 

23,285

 

Total costs and expenses

 

 

89,261

 

 

 

73,015

 

Loss from operations

 

 

(36,421

)

 

 

(46,687

)

Interest (expense) income, net

 

 

(994

)

 

 

90

 

Other income

 

 

 

 

 

144

 

Net loss

 

$

(37,415

)

 

$

(46,453

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

Unrealized loss on available-for-sale securities

 

 

 

 

 

(18

)

Foreign currency translation adjustment

 

 

(286

)

 

 

(17

)

Total other comprehensive loss

 

 

(286

)

 

 

(35

)

Comprehensive loss

 

$

(37,701

)

 

$

(46,488

)

Net loss per common share, basic and diluted

 

$

(1.02

)

 

$

(1.31

)

Weighted-average common shares outstanding, basic and diluted

 

 

36,792,980

 

 

 

35,426,296

 

 

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

 

6


 

FOUNDATION MEDICINE, INC.

Condensed Consolidated Statements of Cash Flows

(unaudited)

(In thousands)

 

 

 

 

 

 

March 31,

 

 

 

2018

 

 

2017

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(37,415

)

 

$

(46,453

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization expense

 

 

5,365

 

 

 

4,466

 

Stock-based compensation expense

 

 

3,208

 

 

 

6,399

 

Amortization of premiums and discounts on marketable securities

 

 

 

 

 

14

 

Gain on disposal of long-lived assets

 

 

 

 

 

(139

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

4,974

 

 

 

2,348

 

Receivable from Roche

 

 

1,059

 

 

 

(2,863

)

Inventory

 

 

(3,230

)

 

 

178

 

Prepaid expenses and other current assets

 

 

(3,143

)

 

 

(30

)

Other assets

 

 

108

 

 

 

82

 

Accounts payable

 

 

3,456

 

 

 

278

 

Accrued expenses and other current liabilities

 

 

(14,388

)

 

 

(1,780

)

Deferred rent and other non-current liabilities

 

 

(366

)

 

 

(571

)

Deferred revenue

 

 

499

 

 

 

(120

)

Roche related-party deferred revenue

 

 

981

 

 

 

(3,453

)

Net cash used in operating activities

 

 

(38,892

)

 

 

(41,644

)

Investing activities

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(5,682

)

 

 

(3,863

)

Purchases of marketable securities and other investments

 

 

 

 

 

(4,996

)

Proceeds from maturities of marketable securities

 

 

 

 

 

34,390

 

Net cash (used in) provided by investing activities

 

 

(5,682

)

 

 

25,531

 

Financing activities

 

 

 

 

 

 

 

 

Proceeds from indebtedness to Roche

 

 

30,000

 

 

 

 

Proceeds from stock option exercises

 

 

3,430

 

 

 

1,571

 

Net cash provided by financing activities

 

 

33,430

 

 

 

1,571

 

Net decrease in cash, cash equivalents, and restricted cash

 

 

(11,144

)

 

 

(14,542

)

Effect of exchange rate changes on cash and cash equivalents

 

 

33

 

 

 

 

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

 

 

73,709

 

 

 

65,012

 

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

 

$

62,598

 

 

$

50,470

 

Supplemental disclosure of non-cash investing and financing activities

 

 

 

 

 

 

 

 

Cash paid for interest

 

$

891

 

 

$

75

 

Acquisition of property and equipment included in accounts payable and accrued

   expenses

 

$

4,528

 

 

$

696

 

 

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

 

7


 

FOUNDATION MEDICINE, INC.

Notes to Condensed Consolidated Financial Statements

(unaudited)

 

1.

Nature of Business and Basis of Presentation

Foundation Medicine, Inc., and its wholly-owned subsidiaries, Foundation Medicine Securities Corporation and FMI Germany GmbH (collectively, the “Company”), is a molecular information company focused on fundamentally changing the way in which patients with cancer are evaluated and treated. The Company believes an information-based approach to making clinical treatment decisions based on comprehensive genomic profiling will become a standard of care for patients with cancer. The Company derives revenue from selling services that are enabled by its molecular information platform to physicians and biopharmaceutical companies.

The Company’s molecular information services for genomic profiling, FoundationOne CDx, an FDA-approved broad companion diagnostic assay for solid tumors, FoundationOne for solid tumors, FoundationOneHeme for hematologic malignancies and sarcomas, FoundationACT, a blood-based (liquid biopsy) assay to measure circulating tumor DNA (“ctDNA”), and FoundationFocus CDx BRCA , an FDA-approved, companion diagnostic assay to aid in identifying women with ovarian cancer for whom treatment with Rubraca™ (rucaparib) is being considered, are widely available comprehensive genomic profiles designed for use in the routine care of patients with cancer. Following the FDA’s approval of FoundationOne CDx in November 2017, the Centers for Medicare & Medicaid Services (“CMS”) issued a final National Coverage Determination, or NCD, in March 2018 that establishes nationwide Medicare coverage for FoundationOne CDx for all solid tumor types when ordered by the patient’s treating physician for Medicare beneficiaries with advanced cancer ( i.e. , either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer), who either have not been previously tested using FoundationOne CDx for the same primary diagnosis of cancer or are seeking repeat testing with FoundationOne CDx for a new primary cancer diagnosis, and continue to seek further cancer therapy.

To accelerate its commercial growth and enhance its competitive advantage, the Company is developing and commercializing new molecular information services for physicians and biopharmaceutical companies, strengthening its commercial organization, introducing new marketing, education and provider engagement efforts, growing its molecular information knowledgebase, called FoundationCORE, pursuing reimbursement from regional and national third-party payors, publishing scientific and medical advances, and fostering relationships throughout the oncology community.

The accompanying condensed consolidated financial statements are unaudited. In the opinion of management, the unaudited condensed consolidated financial statements contain all adjustments considered normal and recurring and necessary for their fair presentation. Interim results are not necessarily indicative of results to be expected for the year. These interim financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, these unaudited condensed consolidated financial statements do not include all of the information and footnotes necessary for a complete presentation of financial position, results of operations, comprehensive loss and cash flows. The Company’s audited consolidated financial statements as of and for the year ended December 31, 2017 included information and footnotes necessary for such presentation and were included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 7, 2018. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto as of and for the year ended December 31, 2017.

 

2.

Summary of Significant Accounting Policies

Summary of 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.

Revenue Recognition

The Company derives revenue from the provision of molecular information services provided to its ordering physicians and biopharmaceutical customers, as well as from pharma research and development services provided to its biopharmaceutical customers. Molecular information services include molecular profiling and the delivery of other molecular information derived from the Company’s platform. Pharma research and development services include the development of new platforms and information solutions, including companion diagnostic development. The Company currently receives payments from commercial third-party payors, Medicare, certain hospitals and cancer centers with which it has direct-bill relationships, individual patients, and its biopharmaceutical customers. All amounts are due to be paid in accordance with the customers agreed upon payment terms and we have not identified the existence of any significant financing components.

8


 

Effective January 1, 2018, the Company began recogn izing revenue in accordance with FASB ASC Topic 606,  Revenue from Contracts with Customers  (“ASC 606”). The Company adopted ASC 606 utilizing the modified retrospective method, meaning the cumulative effect of applying the standard was recognized to openin g retained earnings as of January 1, 2018 . ASC 606 provides for 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.

Performance Obligations

Molecular Information Services

Clinical

Our clinical contracts included within molecular information services typically have a single performance obligation to transfer molecular profiling services to either a patient or a facility. In certain limited contracted scenarios, such as arrangements with academic medical centers, the transaction price is stated within the contract and is therefore fixed consideration. For most of our clinical volume, we identified the patient as the customer in Step 1 of the model and have determined an implied contract exists with the patient in Step 1. As such, a stated contract price does not exist and the transaction price for each contract represents variable consideration. In developing the estimate of variable consideration, we utilize the expected value method under a portfolio approach. Our estimate requires significant judgment and is developed using historical reimbursement data from payors and patients, as well as known current reimbursement trends not reflected in the historical data. As these contracts typically have a single performance obligation, no allocation of the transaction price is required in Step 4 of the model. Control over molecular information services is transferred to our ordering physicians at a point in time. Specifically, we determined the customer obtains control of the promised service upon our delivery of the test results. Certain incremental costs, such as commissions, are incurred in obtaining clinical contracts. We have elected to utilize the practical expedient to expense incremental costs of obtaining a contract that meet the capitalization criteria, as the amortization period of any contract acquisition asset would be one year or less due to the short-term nature of our clinical contracts.

Biopharma

Our biopharma contracts included within molecular information services may include single or multiple performance obligations depending on the contract, and may include different molecular information service offerings, such as molecular profiling, provision of data through either database queries or subscription access to our platform, and clinical trial enrollment assistance, as separately identifiable from other promises in the contracts and therefore distinct performance obligations.

The transaction price in biopharma molecular information service contracts is typically fixed consideration. In certain instances, contracts may include variable consideration. In these contracts, variable consideration is estimated utilizing the expected value method. The primary method used to determine standalone selling price for the biopharma molecular information services is observable standalone selling price. When standalone selling price is not directly observable, the primary method used to estimate standalone selling price for molecular information services is the adjusted market assessment approach, under which we evaluate the market in which we sell the services and estimate the price that a customer in that market would be willing to pay for those services.

Control over biopharma molecular information services from molecular profiling and database queries is transferred to customers at a point in time. We determined the customer obtains control of the promised service upon delivery of the test results or the delivery of responses to database queries to the biopharma partner. Control over biopharma molecular information services from subscription access to our data platform is transferred to customers ratably over time. We determined that the customer obtains control of the promised service as we host the content throughout the contract term. Control over biopharma molecular information services from clinical trial enrollment assistance is transferred to customers ratably over time. We determined that the customer obtains control of the promised service as we stand ready to perform such services throughout the contract term.

Pharma Research and Development Services

Our biopharma contracts included within pharma research and development services may include single or multiple performance obligations depending on the contract. Research and development (“R&D”) services typically represent a single performance obligation as the Company performs a significant integration service for the individual goods or services in the R&D workstream, such as analytical validation and regulatory submissions. The individual promises are not separately identifiable from other promises in the contracts and, therefore, are not distinct. However, in certain contracts, a partner may engage the Company for multiple distinct R&D workstreams which are both capable of being distinct and separately identifiable from other promises in the contracts and, therefore, distinct performance obligations. Additionally, for regulatory contracts in pursuit of approval of a companion diagnostic assay, the Company identifies a performance obligation for commercial availability of the assay subsequent to obtaining regulatory approval.

9


 

The transaction price can consist of a combination of an upfront fee, performance-based development milestones, cost reimbursement, fixed per sample fees, commercial royalties, and commercial milestones. With the exception of upfront and fixed per sample fees, the other forms of compensation represent variable consideration. Variable consideration in the form of cost reimbursement and commercial royalties is estimated using the expec ted value method. Variable consideration in the form of development and commercial milestones is estimated using the most likely amount method. All variable consideration is constrained such that it is probable a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Application of the constraint for variable consideration to milestone payments is an area that requires significant judgment. In making this assessment, the Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be managed to achieve the respective milestone and the level of effort and investment required to achieve the respective milestone.

The primary method used to estimate standalone selling price for the R&D service performance obligations is the expected cost plus a margin approach, under which we forecast our expected costs of satisfying each performance obligation and then add an appropriate margin for that distinct good or service. The primary method used to estimate standalone selling price for a commercial availability performance obligation is the adjusted market assessment approach, under which we evaluate the market in which we sell the services and estimate the price that a customer in that market would be willing to pay for those services. The estimation of standalone selling price is an area that requires significant judgment, as it impacts the allocation objective in Step 4 of the model. Revenue will be recognized over time for R&D services and commercial availability services. Specifically, for R&D services we will recognize revenue using an input method to measure progress, utilizing costs incurred to-date relative to total expected costs as our measure of progress. For commercial availability services, we will recognize revenue using an input method to measure progress, resulting in a time-elapsed measure of progress.

The Company performs R&D services as part of its normal activities. The Company records payments for these services as Pharma research and development services revenue in the Consolidated Statements of Operations and Comprehensive Loss. The R&D costs incurred by the Company under these arrangements are included as Research and development expenses in the Company’s Consolidated Statements of Operations and Comprehensive Loss given these costs are related to the development of new services to be owned and offered by the Company to its customers.

Significant Judgments and Contract Estimates

Molecular Information Services

For our clinical molecular information services, we have concluded that an implied contract exists with the patient. This is a significant judgment as contract existence is a requirement to applying the general five-step model of ASC 606.

Accounting for clinical revenue contracts includes estimation of the transaction price, defined as the amount we expect to be entitled to receive in exchange for providing the services under the contract. Due to our out-of-network status with the majority of payors, estimation of the transaction price represents variable consideration. In order to estimate variable consideration, we utilize a portfolio approach in which payors with similar reimbursement experience are grouped into portfolios. Our estimates of variable consideration are based primarily on historical reimbursement data. Certain assumptions will also be adjusted based on known and anticipated factors not reflected in the historical reimbursement data. We monitor these accrual estimates at each reporting period based on actual cash collections in order to assess whether a revision to the estimate is required. Both the initial accrual estimate and any subsequent revision to the estimate contain uncertainty and require the use of judgment in the estimation of the transaction price and application of the constraint for variable consideration.

Pharma Research and Development Services

Accounting for biopharma revenue contracts includes several judgments and estimates which impact the timing and pattern of revenue recognition. Specifically, biopharma contracts require evaluation of separability of promised services, estimation of the transaction price, allocation of the transaction price to performance obligations, and estimation of measure of progress toward complete satisfaction for those performance obligations satisfied over time.

Certain biopharma contracts, typically those for pharma R&D services, contain promises to deliver multiple services. The process for evaluating contracts for material promises, in contrast to immaterial promises or administrative tasks, requires judgment. Once material promises have been identified, we then evaluate whether these promises are both capable of being distinct and distinct within the context of the contract. If both of these criteria are satisfied, a separate performance obligation will be identified. If both criteria are not satisfied, certain promises will be combined in the identification of a combined performance obligation. In assessing whether a promised service is capable of being distinct, the Company considers whether the customer could benefit from the service either on its own or together with other resources that are readily available to the customer, including factors such as the research, development, and commercialization capabilities of a third party and the availability of the associated expertise in the general marketplace. In assessing whether a promised service is distinct within the context of the contract, the Company considers whether we provide a significant integration of the services, whether the services significantly modify or customize one another, or whether the services are highly interdependent or interrelated.

10


 

The nature of certain biopharma contracts, primarily contracts for pharma R& D services, requires that the transaction price must be estimated, including application of the constraint to performance-based milestones. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be managed to achieve the respective milestone and the level of effort and investment required to achieve the respective milestone in making this assessment. Application of the constraint is based on our historical experience with similar milestones, the deg ree of complexity and uncertainty associated with each milestone, and whether achievement of the milestone is dep endent on parties other than the Company . The constraint for variable consideration is applied such that it is probable a significant reversal of revenue will not occur when the uncertainty associated with the contingency is resolved. Application of the constraint for variable consideration is updated at each reporting period as a revision to the estimated transaction price.

Once the transaction price has been estimated, the standalone selling price for each identified performance obligation must be determined in order to allocate the transaction price to performance obligations. Observable standalone selling price is used when available. When an observable price is not available, standalone selling price is estimated using either the adjusted market assessment approach or the expected cost plus a margin approach, utilizing the approach which maximizes the use of observable inputs. Under the adjusted market assessment approach, we utilize pricing on historical similar transactions as well as competitor pricing as relevant inputs. Under the expected cost plus a margin approach, we utilize internal cost models for required personnel and sample resources as the relevant inputs.

Lastly, once the transaction price has been allocated to the identified performance obligations, we must determine the timing and pattern of revenue recognition. For certain biopharma services, particularly pharma R&D services satisfied over time, this requires estimation of the total cost pool in order to determine our measure of progress under the input method. This cost pool is the same cost model utilized to estimate standalone selling price under the expected cost plus a margin approach. At the end of each reporting period, we track actual costs incurred in order to measure progress under the input method and recognize revenue accordingly.

For further discussion on the Company’s revenue recognition, refer to Note 4: Revenue and Note 7: Contract Balances.

Reclassifications

Certain reclassifications have been made to the revenue captions of the Condensed Consolidated Statements of Operations and Comprehensive Loss to conform to the current classifications. These reclassifications had no net effect on the Company’s consolidated results.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.

The Company adopted ASU 2014-09 Revenue from Contracts with Customers and all related amendments (collectively codified as ASC 606) on January 1, 2018 utilizing the modified retrospective method, meaning the cumulative effect of applying the standard to all contracts that were not completed as of the date of initial application was recognized to opening retained earnings as of January 1, 2018. The Company identified certain differences in accounting for revenue recognition as a result of adoption of ASC 606 which are expected to have a material impact on its financial position or results of operations. These differences are discussed below and any other identified policy differences are not expected to have a material impact on the Company’s financial position or results of operations.

For molecular information services revenue, the Company identified a difference in accounting for certain revenue arrangements from the application of the new revenue accounting standard as compared to the previous revenue accounting standards. Historically, for certain clinical customers, the Company deferred revenue recognition until cash receipt when the price pursuant to the underlying customer arrangement was not fixed and determinable and collectability was not reasonably assured. Under the new standard, this is considered variable consideration. For these arrangements, the Company will record an estimate of the transaction price, subject to the constraint in the new standard for variable consideration, as revenue at the time of delivery. This estimate will be monitored in subsequent periods and adjusted as necessary based on actual collection experience. This will result in earlier revenue recognition as compared to previous revenue recognition.

For pharma research and development services revenue, the Company identified a difference in accounting for certain contracts from the application of the new revenue accounting standard as compared to previous revenue accounting standards. Historically, for arrangements with regulatory and other developmental milestone payments, the Company limited revenue recognition based on the right to invoice the customer. Under the new standard, for these arrangements, the Company will constrain revenue such that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Based on the facts and circumstances associated with each milestone, this could result in a change to the timing and pattern of revenue recognition as compared to previous accounting policy.

11


 

Effective January 1, 2018, the Company recognizes revenue in accordance with ASC 606. Comparative information from prior periods has not been restated and continues to be reported under the accounting standards in effect for those periods.

The cumulative effect of changes made to the Condensed Consolidated Balance Sheet at January 1, 2018 for the adoption of ASC 606 were as follows (in thousands):

 

 

Balance at December 31,

2017

 

 

Adjustments

Due to ASC

606

 

 

Balance at

January 1,

2018

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Accounts receivable

 

$

19,967

 

 

$

17,243

 

 

$

37,210

 

Prepaid expenses and other current assets

 

 

9,118

 

 

 

710

 

 

 

9,828

 

Other assets

 

 

1,760

 

 

 

573

 

 

 

2,333

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31,

2017

 

 

Adjustments

Due to ASC

606

 

 

Balance at

January 1,

2018

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Deferred revenue

 

$

2,212

 

 

$

156

 

 

$

2,368

 

Roche related-party deferred revenue

 

 

3,742

 

 

 

78

 

 

 

3,820

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31,

2017

 

 

Adjustments

Due to ASC

606

 

 

Balance at

January 1,

2018

 

Equity:

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated deficit

 

$

(506,349

)

 

$

18,292

 

 

$

(488,057

)

In accordance with ASC 606 requirements under the modified retrospective method of adoption, the disclosure of the impact of adoption on our Condensed Consolidated Statement of Operations and Condensed Consolidated Balance Sheet was as follows (in thousands):

 

 

 

For the three months ended March 31, 2018

 

Revenue:

 

As  Reported

Under ASC

606

 

 

Effect of Change

Higher/(Lower)

 

 

Balances Without Adoption of ASC 606

 

Molecular information services

 

$

31,943

 

 

$

3,212

 

 

$

35,155

 

Related-party molecular information services from Roche

 

 

14,648

 

 

 

(374

)

 

 

14,274

 

Pharma research and development services

 

 

4,782

 

 

 

(3,923

)

 

 

859

 

Related-party pharma research and development services from Roche

 

 

1,467

 

 

 

 

 

1,467

 

12


 

 

 

 

March 31, 2018

 

Assets:

 

As  Reported

Under ASC

606

 

 

Effect of Change

Higher/(Lower)

 

 

Balances Without Adoption of ASC 606

 

Accounts receivable

 

$

32,222

 

 

$

(14,008

)

 

$

18,214

 

Prepaid expenses and other current assets

 

 

13,003

 

 

 

(4,771

)

 

 

8,232

 

Other assets

 

 

2,225

 

 

 

(491

)

 

 

1,734

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities:

 

As  Reported

Under ASC

606

 

 

Effect of Change

Higher/(Lower)

 

 

Balances Without Adoption of ASC 606

 

Deferred revenue

 

$

2,867

 

 

$

(179

)

 

$

2,688

 

Roche related-party deferred revenue

 

 

4,801

 

 

 

286

 

 

 

5,087

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Equity:

 

As  Reported

Under ASC

606

 

 

Effect of Change

Higher/(Lower)

 

 

Balances Without Adoption of ASC 606

 

Accumulated deficit

 

$

(525,472

)

 

$

(19,377

)

 

$

(544,849

)

ASC 606 did not have an aggregate impact on the Company’s net cash used in operating activities, but resulted in offsetting changes in certain assets and liabilities presented within net cash used in operating activities in the Company’s Condensed Consolidated Statement of Cash Flows, as reflected in the above tables.

In January 2016, the FASB issued ASU 2016-01, Recognition and Measurement of Financial Assets and Financial Liabilities (“ASU 2016-01”). ASU 2016-01 provides guidance about how to recognize, measure, present and make disclosures about certain financial assets and financial liabilities under Topic 825. ASU 2016-01 became effective for fiscal years beginning after December 15, 2017. The adoption of ASU 2016-01 did not have a material effect on the Company’s consolidated financial statements or disclosures.

In February 2016, the FASB issued ASU 2016-02, Leases (“ASU 2016-02”), to increase transparency and comparability among organizations by recognizing lease assets and lease liabilities, including for operating leases, on the balance sheet and disclosing key information about leasing arrangements. ASU 2016-02 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The Company is still performing its assessment of ASU 2016-02, however expects that substantially all of its operating lease commitments will be subject to the new guidance.

In November 2016, the FASB issued ASU 2016-18,  Restricted Cash  (“ASU 2016-18”). ASU 2016-18 provides guidance on the classification of restricted cash and cash equivalents in the statement of cash flows. Although it does not provide a definition of restricted cash or restricted cash equivalents, it states that 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 became effective for fiscal years beginning after December 15, 2017. The adoption of ASU 2016-18 did not have a material effect on the Company’s consolidated financial statements or disclosures.

In May 2017, the FASB issued ASU 2017-09, Scope of Modification Accounting (“ASU 2017-09”). ASU 2017-09 provides guidance about which terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718. ASU 2017-09 became effective for fiscal years beginning after December 15, 2017. The adoption of ASU 2017-09 did not have an effect on the Company’s consolidated financial statements or disclosures.

 

3.

Significant Agreements

Roche Holdings, Inc. and its affiliates

Summary of the Transaction

On January 11, 2015, the Company signed a broad strategic collaboration with Roche Holdings, Inc. and certain of its affiliates (collectively, “Roche”) to further advance the Company’s leadership position in genomic analysis and molecular information solutions in oncology. The transaction, which is a broad multi-part arrangement that includes an R&D collaboration, an ex-U.S. commercial collaboration, a U.S. medical education collaboration, and an equity investment with certain governance provisions, closed on April 7, 2015.

13


 

Under the terms of the transaction, Roche (a) made a primary investment of $250,000,000 in cash through the purchase of 5,000,000 newly issued shares of the Company’s common stock at a purchase price of $50.00 per share and (b) completed a tender offer to acquire 15,604,288 outstanding shares of the Company’s common stock at a price of $50.00 per share. Immediately following the closing of the transaction, Roche owned approximately 61.3% of the outstanding shares. As of March 31, 2018, Roche ’s ownership was approximately 56.9% of the outstanding shares. Upon the closing of the transaction, the size of the Board of Directors of the Company (“Board”) was increased to nine, including three designees of Roche. In February 2017, the Board was incr eased to ten members. In June 2017, the Board was decreased to nine members when a director retired from the Board at our 2017 annual meeting of stockholders.

The Company assessed the agreements related to each of the R&D collaboration, an ex-U.S. commercial collaboration, and the U.S. medical education collaboration and determined they should be treated as separate contracts for accounting purposes.

Summary of the R&D Collaboration Agreement

Under the terms of the Collaboration Agreement by and among the Company, F. Hoffmann-La Roche Ltd, and Hoffmann-La Roche Inc., dated January 11, 2015, as amended (the “R&D Collaboration Agreement”), Roche could pay the Company more than $150,000,000 over a period of five years to access its molecular information platform, to reserve capacity for sample profiling, and to fund R&D programs. Amounts under the R&D Collaboration Agreement will be received as services are performed and obligations are fulfilled under each platform program. Roche will utilize the Company’s molecular information platform to standardize sample profiling conducted as part of its clinical trials, to enable comparability of clinical trial results for R&D purposes, and to better understand the potential for combination therapies. In addition, Roche and the Company will jointly develop solutions related to cancer immunotherapy testing, blood-based genomic analysis using ctDNA assays, and next generation companion diagnostics, each of which represents a distinct platform within the R&D Collaboration Agreement. The R&D Collaboration Agreement is governed by a Joint Management Committee (“JMC”) formed by an equal number of representatives from the Company and Roche. There are also other sub-committees for each platform that will be established to oversee the day to day responsibilities of the respective platform. The JMC will, among other activities, review and approve R&D plans and establish and set expectations for the other platform sub-committees. The JMC and other sub-committees, although considered promises under the arrangement, are immaterial in relation to the entire arrangement and therefore were not identified as performance obligations.

On April 6, 2016, the Company and Roche entered into the First Amendment to the R&D Collaboration Agreement, which reduced certain restrictions on the Company’s activities in immuno-oncology and revised certain criteria for the achievement of a development milestone.

On June 16, 2016, the Company and Roche entered into the Second Amendment to the R&D Collaboration Agreement, which set forth the terms of an omnibus development program to provide for R&D projects that do not fall within the scope of the other programs already covered by the R&D Collaboration Agreement . R&D reimbursements and milestone payments will be recognized using an input method measure of progress based on costs incurred by the Company .

On July 25, 2016, the Company and Roche entered into a Third Amendment to the R&D Collaboration Agreement, which modified certain exclusivity provisions relating to cancer immunotherapy.

On December 20, 2016, the Company and Roche entered into a Fourth Amendment to the R&D Collaboration Agreement, which further modified certain exclusivity provisions relating to cancer immunotherapy.

On September 8, 2017, the Company and Roche entered into a Fifth Amendment to the R&D Collaboration Agreement, which reduced certain exclusivity provisions relating to blood-based tumor mutational burden assays.

On November 1, 2017, the Company and Roche entered into a Sixth Amendment to the R&D Collaboration Agreement, which further modified certain exclusivity provisions relating to cancer immunotherapy.

Molecular Information Platform Program

Under the molecular information platform program within the R&D Collaboration Agreement, the following promises were identified: (i) cross-licenses for access to relevant intellectual property (“IP”), (ii) sample profiling, (iii) access to the Company’s molecular information database, and (iv) full-time equivalent persons (“FTEs”) per year for performance of database queries and the delivery of results.

14


 

The Company assessed which promises within the arrangement are distinct from the other promises, and identified the following separate performance obligations: (i) sample profiling and (ii ) access to the Company’s molecular information database and FTEs per year for the performance of database queries and the delivery of results. The cross-licenses grant each party access to relevant IP to perform under the contract or to exploit the promis ed services. The licenses are delivered at the inception of the arrangement and relate to development and sample profiling work performed under the platform. The Company does not sell the licenses separately as they are closely connected to the development and sample profiling activities and have little value to Roche without these other promised services. Therefore, the licenses are combined with the other performance obligations identified under the molecular information platform program and are not consi dered distinct.

The Company identified an estimated transaction price of approximately $85,000,000 related to the molecular information platform program, which was allocated to the individual performance obligations based on standalone selling price. Revenue related to sample profiling will be recognized at the point in time at which test results are delivered to Roche. The database access and FTE payments will be recognized using a time-elapsed measure of progress over the five-year contract life. The FTEs will perform database queries and will deliver results of the requested database queries. The value to Roche is not only the access to the database, but also the service being performed by the FTEs. Therefore, the Company concluded the FTEs should be combined with the database access as one performance obligation.

Immunotherapy Testing Platform Development Program

Under the immunotherapy testing platform development program within the R&D Collaboration Agreement, the following promises were identified: (i) cross-licenses for access to relevant IP and (ii) obligations to perform R&D services for immuno-biomarker discovery and signature identification.

The Company assessed which promises within the arrangement are distinct from the other promises, and identified a single performance obligation for the performance of R&D services for immuno-biomarker discovery and signature identification. The cross-licenses grant each party access to relevant IP of the other party to perform such party’s obligations under the contract and to exploit the promised service. The licenses are delivered at the inception of the arrangement and relate to R&D work performed under the platform. The Company does not sell the licenses separately as they are closely connected to the R&D activities and have little value to Roche without these other promised services. Therefore, the licenses are combined with the other performance obligation identified under the immunotherapy testing platform development program and are not considered distinct.

Under this platform, Roche will reimburse the Company for certain R&D costs incurred related to the immuno-biomarker discovery and signature identification activities, as well as costs incurred in the development of immunotherapy assays for clinical studies. In addition, Roche will be required to make certain milestone payments upon the achievement of specified clinical events under the immunotherapy testing platform development program. Clinical milestone payments up to $6,600,000 in the aggregate are triggered upon the initiation of Roche clinical trials using immunotherapy assays developed under the R&D Collaboration Agreement. The R&D reimbursements and clinical milestone payments will be recognized using an input method measure of progress based on costs incurred by the Company.

Circulating Tumor DNA (ctDNA) Platform Development Program

Under the ctDNA platform development program within the R&D Collaboration Agreement, the following promises were identified: (i) cross-licenses for access to relevant IP and (ii) obligations to perform R&D services for the development of a ctDNA clinical trial assay, including its analytical validation.

The Company assessed which promises within the arrangement are distinct from the other promised services, and identified a single performance obligation for the performance of R&D services for the development of a ctDNA clinical trial assay. The cross-licenses grant each party access to relevant IP of the other party to perform such party’s obligations under the contract and to exploit the promised service. The licenses are delivered at the inception of the arrangement and relate to R&D work performed under the platform. The Company does not sell the licenses separately as they are closely connected to the R&D activities and have little value to Roche without these other promised services. Therefore, the licenses are combined with the other performance obligation identified under the ctDNA platform development program and are not considered distinct.

The Company was responsible for all R&D costs under the ctDNA platform development program. Roche was required to make certain milestone payments upon the achievement of specified events. Milestone payments equal to $12,000,000 in the aggregate were triggered upon successful analytical validation of a ctDNA clinical trial assay and delivery of a ctDNA clinical trial assay for use in Roche clinical trials. All milestones were recognized at the point in time at which benefit transferred to Roche.

15


 

Companion Diagnostics (CDx) Development Program

Under the CDx development program within the R&D Collaboration Agreement, the following promises were identified: (i) cross-licenses for access to relevant IP, (ii) obligations to perform R&D services for the development of CDx assays for use in connection with certain Roche products, and (iii) obligations to maintain commercial availability of our assay inclusive of Roche biomarkers.

The Company assessed which promises within the arrangement are distinct from the other promised services, and identified the following separate performance obligations: (i) obligation to perform R&D services for the development of a CDx assay and (ii) obligation to maintain commercial availability of our assay inclusive of Roche biomarkers. The cross-licenses grant each party access to relevant IP of the other party to perform such party’s obligations under the contract and to exploit the promised services. The licenses are delivered at the inception of the arrangement and relate to R&D work performed under the platform. The Company does not sell the licenses separately as they are closely connected to the R&D activities and have little value to Roche without these other promised services. Therefore, the licenses are combined with the obligation to perform R&D services for the development of a CDx assay as a single performance obligation.

Under this platform, Roche reimbursed the Company for certain costs incurred related to R&D under the CDx development program with respect to approved and investigational markers. In addition, Roche was required to make certain milestone payments upon the achievement of specified regulatory and commercial events under the CDx development program. Regulatory milestone payments of $600,000 were triggered upon obtaining FDA approval of a premarket approval application for each CDx product developed under the arrangement. The R&D reimbursements and regulatory milestone payments were recognized using an input method measure of progress based on costs incurred by the Company. Commercial milestone payments are triggered upon the performance of a specified number of CDx assays for certain commercial clinical diagnostic uses. Any commercial milestone payments received by the Company will be recognized using an input method to measure progress, resulting in a time-elapsed measure of progress.  

Termination of the R&D Collaboration Agreement

The R&D Collaboration Agreement may be terminated by either the Company or Roche on a program-by-program basis, upon written notice, in the event of the other party’s uncured material breach. Roche may also terminate the entire R&D Collaboration Agreement or an individual program under the R&D Collaboration Agreement for any reason upon written notice to the Company, subject to certain exceptions. If the R&D Collaboration Agreement is terminated, license and IP rights are returned to each party and the Company must return to Roche or dispose of any unused samples delivered for profiling purposes. If Roche terminates the R&D Collaboration Agreement as a result of a breach by the Company, Roche retains the license rights granted to certain IP of the Company, and the Company shall refund to Roche any reserved capacity fees and database access fees previously received by the Company that were unused based on the passage of time up to termination for the given contract year. If the R&D Collaboration Agreement is terminated by Roche without cause or by the Company due to a breach by Roche, the Company has a right to receive the contractual payments it would have expected to receive for each program had the agreement not been terminated.

Summary of the Ex-U.S. Commercialization Agreement

In addition to the R&D Collaboration Agreement, the Company entered into the Ex-U.S. Commercialization Agreement with Roche (as most recently amended and restated in February 2018, the “Ex-U.S. Commercialization Agreement”) designed to facilitate the delivery of the Company’s services outside the United States (“Ex-U.S.”) in partnership with Roche. Pursuant to the Ex-U.S. Commercialization Agreement, on April 7, 2016, Roche obtained Ex-U.S. commercialization rights to the Company’s existing services and to future co-developed services. The Company remains solely responsible for commercialization of its services within the United States. The selected geographic areas where Roche exercised its commercialization rights constitute the “Roche Territory.” For those geographic areas that Roche does not select, the commercialization rights for such geographic areas revert back to the Company. The Ex-U.S. Commercialization Agreement is governed by the JMC. There is also a Joint Operational Committee (“JOC”) that has been established to oversee the activities under the Ex-U.S. Commercialization Agreement. The JMC will have the responsibilities as outlined under the R&D Collaboration Agreement. The JMC and JOC, although considered promises under the arrangement, are immaterial in relation to the entire arrangement and therefore were not identified as performance obligations.

Under the Ex-U.S. Commercialization Agreement, the following promises were identified: (i) the right, granted by means of a license, for Roche to market and sell the Company’s services in the Roche Territory and (ii) obligations to perform sample profiling and other services relating to Company services sold by Roche in the Roche Territory. The Company concluded that the license is delivered at the inception of the arrangement. The Company does not sell the license separately as it is closely connected to the sample profiling and other services and has little value to Roche without these services being performed. Therefore, the promises identified will be combined as a single performance obligation under the Ex-U.S. Commercialization Agreement and revenue will be recognized at the point in time test results are delivered for each test sold by Roche.

16


 

Roche will reimburse the Company for costs incurred in performing sample profiling and other services relating to Company services sold by Roche in the Roche Territory. These reimbursements will be recognized as revenue in the period the sample profiling service has been completed. In addition, Roche will be required to make a one-time milestone payment of $10,000,000 when the aggregate gross margin on sales of certain of the Company’s services reaches $100,000,000 in the Roche Territory in any calendar year. In the e vent Roche does not satisfy its specified commercialization obligations under the agreement, including its obligation to launch Company services in specific countries within a specified timeframe, after a cure period, Roche may be required to make penalty payments to the Company. This milestone payment and these penalty payments will be constrained and recognized in their entirety when the associated contingency is resolved as no enforceable right to payment exists until achievement .

The Company is entitled to receive, on a quarterly basis, tiered payments ranging from the mid-single digits to high-teens based on a percentage of the aggregate gross margin generated on sales of specified services in the Roche Territory during any calendar year. These payments are recognized in the period when tests are delivered.

The Ex-U.S. Commercialization Agreement may be terminated by either the Company or Roche in its entirety or on a country-by-country or product-by-product basis, upon written notice, in the event of the other party’s uncured breach of its material obligations under the agreement. Roche may also terminate the Ex-U.S. Commercialization Agreement without cause on a product-by-product and/or country-by-country basis, upon written notice to the Company, after the initial five-year term. If the Ex-U.S. Commercialization Agreement is terminated, the license and IP rights granted by the Company to Roche terminate. In addition, if Roche terminates the Ex-U.S. Commercialization Agreement as a result of a breach by the Company, Roche may seek damages via arbitration or be eligible to receive either a one-time payment reflecting the value of the terminated services or a royalty on sales of the terminated products based on the royalty Roche would have paid the Company for the terminated products had the Ex-U.S. Commercialization Agreement not been terminated.

Summary of the U.S. Education Agreement

Within the United States, the Company has entered into the U.S. Education Collaboration Agreement (the “U.S. Education Agreement”) with Genentech, Inc. (“Genentech”), an affiliate of Roche. Genentech has agreed to engage its pathology education team to provide information and medical education to health care providers regarding comprehensive genomic profiling in cancer. The Company will pay Genentech on a quarterly basis for costs incurred by Genentech in conducting the education activities based on a number of factors. The total amount of payments to be made over the course of the arrangement is immaterial and all payments will be expensed as incurred.

IVD Collaboration Agreement

On April 6, 2016, the Company entered into a Master IVD Collaboration Agreement (the “IVD Collaboration Agreement”) with F. Hoffmann-La Roche Ltd and Roche Molecular Systems, Inc., which memorializes in a definitive agreement the terms set forth in that certain Binding Term Sheet for an In Vitro Diagnostics Collaboration, by and between F. Hoffmann-La Roche Ltd and the Company, which was entered into in connection with the Company’s strategic collaboration with Roche.

The IVD Collaboration Agreement provides terms for the Company and Roche to collaborate non-exclusively to develop and commercialize  in vitro  diagnostic versions of certain existing Company tests, including FoundationOne and FoundationOneHeme, and future Company tests, including those developed under the R&D Collaboration Agreement.

The IVD Collaboration Agreement expires on April 7, 2020, unless earlier terminated as provided therein. Roche also has the right, in its sole discretion, to extend the term of the IVD Collaboration Agreement for additional two-year periods of time during any period of time in which Roche continues to hold at least 50.1% of the Company’s capital stock. Either party may terminate the IVD Collaboration Agreement for an uncured breach of the agreement, or for insolvency or bankruptcy.

Biopharmaceutical Partner

In July 2012, the Company entered into a Master Services Agreement (“Services Agreement”) with a biopharmaceutical partner (“Partner”) to perform sample profiling at the Partner’s request. The Services Agreement established the legal and administrative framework for the partnership between the entities. The Services Agreement also included a right for the Partner to initiate an exclusive negotiation with the Company for the development of a Companion Diagnostic (“CDx”). In March 2014, the Company and Partner expanded the scope of work by executing a Companion Diagnostic Agreement (“Amended Agreement”), thereby amending the Services Agreement to include the joint development and regulatory approval for a CDx. The Amended Agreement defined the term of the arrangement as the earlier of five years or receipt of certain regulatory approvals of a CDx. The Company concluded that the amendment to the original Services Agreement should be treated as a new agreement pursuant to ASC 606 as the Amended Agreement changed both the scope and price of the existing arrangement.

17


 

The Company identified six promises under the Amended Agreement: (i) cross-licenses for access to relevant IP, (ii) obligations to continue to perform sample profiling pursuant to the original Services Agreement, (iii) obligations to perform specific R&D activities for the development of a CDx assay for use in connection with the Partner’s product, (iv) obligations to assist in obtaining regulatory approval of the Partner’s product at its request, (v) obligations to perform analytical validation of the CDx assay, and (vi) obligations to make the CDx assay commercially available, following any require d regulatory approval.

The Company then determined the following promises were separate performance obligations: (i) obligations to continue to perform sample profiling pursuant to the original Services Agreement, (ii) obligations to perform specific R&D activities for the development of a CDx assay for use in connection with the Partner’s product and to provide assistance in obtaining regulatory approval of the Partner’s product at its request, inclusive of analytical validation of the CDx assay, and (iii) obligations to make the CDx assay commercially available, following any regulatory approval obtained. The cross-licenses grant each party access to relevant IP of the other party to perform such party’s obligations under the contract and to exploit the promised services. The licenses are delivered at the inception of the arrangement and primarily relate to the R&D development activities performed under the Amended Agreement. The Company does not sell the licenses separately as they are closely connected to the R&D development activities and have little value to the Partner without the other promised services. Therefore, the licenses are combined with the obligation to perform R&D services for the development of a CDx assay as a single performance obligation.

Under the Amended Agreement, the Partner pays a fixed fee for each sample to be profiled; will reimburse the Company for a portion of costs incurred in performing analytical validation of the CDx assay; and will be required to make certain substantive milestone and other payments upon the achievement of specified regulatory and clinical events tied to the development and commercialization of the CDx. The estimated transaction price under the Amended Agreement was allocated to the performance obligations based on standalone selling price. The transaction price allocated to sample profiling is recognized as results of sample profiling are delivered. Consideration allocated to the R&D development activities is recognized using an input method measure of progress based on costs incurred by the Company. As of December 31, 2016, the CDx assay had achieved regulatory approval and the regulatory and development obligations under the Amended Agreement had been completed. Consideration allocated to the commercial availability performance obligation is recognized using a time-elapsed measure of progress.

Under the Amended Agreement, the Company recognized revenue of $2,325,000 and $306,000 for the three months ended March 31, 2018 and 2017, respectively, which was primarily related to sample profiling.

 

4.

Revenue

Refer to Note 2: Summary of Significant Accounting Policies and Note 7: Contract Balances for a complete description of our revenue recognition policy under ASC 606, as well as comparative information demonstrating the impact of ASC 606 on our consolidated financial statements.

 

We disaggregate our revenue from contracts with customers by type of service, as we believe this best depicts how the nature, amount, timing, and uncertainty of our revenue and cash flows are affected by economic factors. The following tables present our revenue disaggregated by type of service.

By Service Offering – Third Party:

 

 

Three Months Ended March 31,

 

 

 

 

2018

 

 

 

2017

 

Clinical sample profiling services

 

$

15,589

 

 

$

10,649

 

Pharma sample profiling services

 

 

13,106

 

 

 

2,454

 

Other molecular information services

 

 

3,248

 

 

 

2,491

 

Total molecular information services

 

 

31,943

 

 

 

15,594

 

R&D and regulatory services

 

 

4,782

 

 

 

1,087

 

Total pharma research and development services

 

 

4,782

 

 

 

1,087

 

Total revenue

 

$

36,725

 

 

$

16,681

 

18


 

 

By Service Offering – Related Party:

 

 

Three Months Ended March 31,

 

 

 

 

2018

 

 

 

2017

 

Clinical sample profiling services

 

$

3,198

 

 

$

970

 

Pharma sample profiling services

 

 

10,450

 

 

 

3,534

 

Other molecular information services

 

 

1,000

 

 

 

1,000

 

Total molecular information services

 

 

14,648

 

 

 

5,504

 

R&D and regulatory services

 

 

1,467

 

 

 

4,143

 

Total pharma research and development services

 

 

1,467

 

 

 

4,143

 

Total revenue

 

$

16,115

 

 

$

9,647

 

 

On March 31, 2018, we had $96.1 million of remaining transaction price allocated to performance obligations which are unsatisfied or partially unsatisfied, of which $51.4 million is associated with related parties. For the $51.4 million associated with related parties, we expect to recognize approximately 58 percent of our remaining transaction price as revenue within the next 12 months following March 31, 2018 and an additional 42 percent in the 12 months thereafter. For the remaining $44.7 million, we expect to recognize approximately 23 percent of our remaining transaction price as revenue within the next 12 months following March 31, 2018, an additional 30 percent in the 12 months thereafter, and the remaining 47 percent thereafter. We have elected to utilize the practical expedient of excluding contracts with an original duration of one year or less. As a result, the majority of our molecular information services contracts are excluded from the calculation and the balance is primarily comprised of transaction price associated with our long-term pharma R&D service contracts, as well as the molecular information platform program within the R&D Collaboration Agreement with Roche.

During the three months ended March 31, 2018, we recognized $1.2 million of revenue from performance obligations satisfied in prior periods, as a result of changes in the estimation of the transaction price for certain arrangements. Changes in the estimation of the transaction price for our clinical molecular information services revenue occur when we adjust our initial estimate based on actual cash collection experience from payors. Changes in the estimation of the transaction price for our pharma research and development services revenue occur based on revisions to our estimate of the constraint for variable consideration of performance-based milestones.

 

5 .

Cash and Cash Equivalents

The Company considers all highly liquid investments with original maturity from the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents include bank demand deposits and money market funds that invest primarily in U.S. government-backed securities and treasuries. Cash equivalents are carried at cost, which approximates their fair value.

 

6.

Restricted Cash

Restricted cash consists of deposits securing letters of credit issued to lessors as collateral in connection with the Company’s operating leases. As of each March 31, 2018 and December 31, 2017, the Company had restricted cash of $2,305,000.

 

7.

Contract Balances

The timing of revenue recognition, invoicing, and cash collection results in billed accounts receivable, unbilled receivables (contract assets), and deferred revenue (contract liabilities). The Company presents current contract assets within prepaid expenses and other current assets and non-current contract assets within other assets, while accounts receivable and deferred revenue are presented separately on the Condensed Consolidated Balance Sheet. For clinical molecular information services revenue, billing generally occurs at the same time as revenue recognition, meaning the Company does not record unbilled receivables or deferred revenue related to these services. For biopharmaceutical molecular information services revenue, billing generally occurs at the same time as revenue recognition. However, we sometimes receive payment in advance of services being performed. For example, contracts may contain upfront payments or, for our subscription-type arrangements, may call for invoicing at the start of each quarter. Both of these scenarios result in the recording of deferred revenue. For Pharma research and development services, the timing between revenue recognition and invoicing is likely to vary due to the longer-term nature of these contracts. For example, these contracts often contain upfront payments, which results in the recording of deferred revenue to the extent cash is received prior to our performance of the related services. Conversely, these contracts typically contain performance-based milestones. Dependent on our estimation of variable consideration and application of the constraint, we may recognize revenue as we perform toward these milestones but prior to achievement of the milestones, which would result in the recording of contract assets. In all cases, deferred revenue is relieved as we perform under our obligations and revenue is consequently recognized. Contract assets are relieved when milestones are achieved and we invoice the customer, thereby shifting the balances from contract assets to accounts receivable. Revenue recognized in the three months ended March 31, 2018 that was included in the deferred revenue balance as of December 31, 2017 was $3.9 million and

19


 

represented primarily revenue from provision of sample profiling services under the reserved capacity arrangement with Roche. As of March 31, 2018 , the Company had current unbilled receivables of $4 . 8 million and non-current unbilled receivabl es of $0.5 million , as compared to current unbilled receivables of $ 0.7 million and non-current unbilled receivables of $ 0.6 million as of January 1, 2018. The Company did not record unbilled receivables for its contract assets prior to adoption of ASC 606 on January 1, 2018.

Two customer account receivable balances consisting of $9,099,000 and $4,687,000 were greater than 10% of the total accounts receivable balance, including receivables due from Roche, representing 22% and 11%, respectively, of total accounts receivable at March 31, 2018. Two customer account balances consisting of $10,159,000 and $8,990,000 were greater than 10% of the total accounts receivable balance, including receivables due from Roche, representing 34% and 30%, respectively, of total accounts receivable at December 31, 2017.

 

8.

Inventory

Inventories are stated at the lower of cost or net realizable value on a first-in, first-out basis and are comprised of the following (in thousands):

 

 

March 31, 2018

 

 

December 31, 2017

 

Raw materials

 

$

11,655

 

 

$

8,963

 

Work-in-process

 

 

4,756

 

 

 

4,208

 

 

 

$

16,411

 

 

$

13,171

 

 

 

9.

Property and Equipment

Property and equipment and related accumulated depreciation and amortization are as follows (in thousands):

 

 

 

 

March 31, 2018

 

 

December 31, 2017

 

Lab equipment

 

$

36,767

 

 

$

36,533

 

Computer equipment

 

 

12,256

 

 

 

11,808

 

Software

 

 

11,960

 

 

 

10,694

 

Furniture and office equipment

 

 

5,440

 

 

 

3,959

 

Leasehold improvements

 

 

32,674

 

 

 

26,968

 

Construction in progress

 

 

3,021

 

 

 

7,523

 

Total cost

 

 

102,118

 

 

 

97,485

 

Less: accumulated depreciation and amortization

 

 

(60,511

)

 

 

(56,366

)

Total property and equipment, net

 

$

41,607

 

 

$

41,119

 

 

Depreciation and amortization expense for the three months ended March 31, 2018 and 2017 was $5,365,000 and $4,466,000, respectively. The Company classifies capitalized internal use software in lab equipment, computer equipment and software based on its intended use.

10.

Accrued Expenses

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

 

 

 

March 31, 2018

 

 

December 31, 2017

 

Payroll and employee-related costs

 

$

10,135

 

 

$

19,630

 

Professional services

 

 

6,225

 

 

 

7,935

 

Property and equipment purchases

 

 

699

 

 

 

688

 

Other

 

 

5,334

 

 

 

8,492

 

Total accrued expenses and other current liabilities

 

$

22,393

 

 

$

36,745

 

 

20


 

11.

Debt

On July 31, 2017, the Company entered into an Amendment Letter Agreement (the “Amendment”) with Roche Finance Ltd (“Roche Finance”), amending the Credit Facility Agreement, dated August 2, 2016, between the Company and Roche (the “Existing Credit Facility” and, as amended, the “Roche Credit Facility”).

The Amendment amends certain provisions of the Existing Credit Facility to provide for an extension of the period during which the Company may borrow funds from three to four years, ending August 2, 2020 (the “Draw Period”), and an increase in the available funds from $100 million to $200 million, of which $80 million was made available immediately and $120 million was made available upon the achievement of certain milestones. Pursuant to the Amendment, loans made under the Roche Credit Facility will bear interest at 6.5% per annum, as compared to 5% under the Existing Credit Facility. The Company shall pay Roche quarterly during the Draw Period and for six months thereafter accrued interest on the outstanding principal of the loans. Beginning six months after the Draw Period and for five years thereafter, the Company shall pay Roche quarterly equal payments of principal, with accrued interest, in arrears until maturity of the Roche Credit Facility on February 2, 2026 (the “Final Maturity Date”). The Company shall also pay Roche a quarterly commitment fee of 0.4% per annum on the available commitment until the end of the Draw Period, as compared to 0.3% under the Existing Credit Facility. The other provisions of the Existing Credit Facility remain substantially unchanged. The proceeds from the Roche Credit Facility are intended to be used for research and development and commercialization, corporate development, and working capital management.    

The Roche Credit Facility is secured by a lien on all of the Company’s tangible and intangible personal property, including, but not limited to, shares of its subsidiaries (65% of the equity interests in the case of foreign subsidiaries), intellectual property, insurance, trade and intercompany receivables, inventory and equipment, and contract rights, and all proceeds and services thereof (other than certain excluded assets).

The Roche Credit Facility contains certain affirmative covenants, including, among others, obligations for the Company to provide monthly and annual financial statements, to meet specified minimum cash requirements, to provide tax gross-up and indemnification protection, and to comply with laws. The Roche Credit Facility also contains certain negative covenants, including, among others, restrictions on the Company’s ability to dispose of certain assets, to acquire another company or business, to encumber or permit liens on certain assets, to incur additional indebtedness (subject to customary exceptions), and to pay dividends on the Company’s common stock. The Company was in compliance with its covenants under the Roche Credit Facility as of March 31, 2018.

The Roche Credit Facility contains customary events of default, including, among others, defaults due to non-payment, bankruptcy, failure to comply with covenants, breaches of representations and warranties, a change of control, a material adverse effect and judgment defaults. Upon the occurrence and continuation of an event of default following applicable notice and cure periods, amounts due under the Roche Credit Facility may be accelerated. The Company had no events of default under the Roche Credit Facility as of March 31, 2018.

As of March 31, 2018, the Company had $90 million in borrowings outstanding and $110 million of unused and available credit under the Roche Credit Facility. Interest expense was $1.2 million and $0.1 million for the three months ended March 31, 2018 and 2017, respectively.

 

12.

Net Loss per Common Share

Basic net loss per share is calculated by dividing net loss applicable to common stockholders by the weighted-average shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method and the if-converted method. For purposes of the diluted net loss per share calculation, stock options, and unvested restricted stock are considered to be common stock equivalents, but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive. Therefore, basic and diluted net loss per share applicable to common stockholders was the same for all periods presented.

21


 

The following potential common stock equivalents were not included in the calculation of diluted net loss per common share because the inclusion thereof would be antidilutive.

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2018

 

 

2017

 

Outstanding stock options

 

 

478,132

 

 

 

1,059,795

 

Unvested restricted stock

 

 

914,648

 

 

 

1,468,022

 

Total

 

 

1,392,780

 

 

 

2,527,817

 

 

13.

Fair Value Measurements

The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. FASB ASC Topic 820, Fair Value Measurements and Disclosures establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of a company. Unobservable inputs are inputs that reflect a company’s assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The hierarchy defines three levels of valuation inputs:

 

Level 1 inputs

Quoted prices in active markets for identical assets or liabilities

 

 

Level 2 inputs

Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly

 

 

Level 3 inputs

Unobservable inputs that reflect a company’s own assumptions about the assumptions market participants would use in pricing the asset or liability

The fair value hierarchy prioritizes valuation inputs based on the observable nature of those inputs. Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.

The Company’s financial instruments consist of cash and cash equivalents, restricted cash, accounts receivable, accounts payable, accrued liabilities, and debt. The carrying amount of cash and cash equivalents, restricted cash, accounts receivable, accounts payable, and accrued liabilities approximate their fair values because of the short-term nature of the instruments. The fair value of our outstanding debt balance approximates the carrying value as of the balance sheet date. The principal amount of our outstanding debt balance at March 31, 2018 and December 31, 2017 was $90.0 million and $60.0 million, respectively.

The following tables present information about the Company’s assets and liabilities that are measured at fair value on a recurring basis as of March 31, 2018 and December 31, 2017, and indicate the fair value hierarchy of the valuation techniques utilized to determine such fair value (in thousands):

 

 

Fair Value Measurement at March 31, 2018

 

 

 

Quoted Prices

in Active

Markets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

$

25,263

 

 

$

 

 

$

 

 

$

25,263

 

Total assets

 

$

25,263

 

 

$

 

 

$

 

 

$

25,263

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Indebtedness to Roche

 

$

 

 

$

90,000

 

 

$

 

 

$

90,000

 

Total liabilities

 

$

 

 

$

90,000

 

 

$

 

 

$

90,000

 

22


 

 

 

Fair Value Measurement at December 31, 2017

 

 

 

Quoted Prices

in Active

Markets

(Level 1)

 

 

Significant

Other

Observable

Inputs

(Level 2)

 

 

Significant

Unobservable

Inputs

(Level 3)

 

 

Total

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

$

25,183

 

 

$

 

 

$

 

 

$

25,183

 

Total assets

 

$

25,183

 

 

$

 

 

$

 

 

$

25,183

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Indebtedness to Roche

 

$

 

 

$

60,000

 

 

$

 

 

$

60,000

 

Total liabilities

 

$

 

 

$

60,000

 

 

$

 

 

$

60,000

 

 

The Company measures eligible assets and liabilities at fair value, with changes in value recognized in the statement of operations and comprehensive loss. Fair value treatment may be elected either upon initial recognition of an eligible asset or liability or, for an existing asset or liability, if an event triggers a new basis of accounting. Items measured at fair value on a recurring basis at March 31, 2018 include cash equivalents and indebtedness to Roche. The Company did not elect to remeasure any other existing financial assets or liabilities, and did not elect the fair value option for any other financial assets and liabilities transacted during the three months ended March 31, 2018 and 2017.

 

 

14.

Stockholders’ Equity

The Company has reserved for future issuance the following number of shares of common stock:

 

 

 

March 31, 2018

 

 

December 31, 2017

 

Unvested restricted stock

 

 

914,648

 

 

 

1,164,040

 

Common stock options

 

 

478,132

 

 

 

666,717

 

Shares available for issuance under the 2013 Stock Option and

   Incentive Plan

 

 

4,781,183

 

 

 

3,273,334

 

Shares available for issuance under the 2013 Employee Stock

   Purchase Plan

 

 

788,503

 

 

 

788,503

 

 

 

 

6,962,466

 

 

 

5,892,594

 

 

 

2010 and 2013 Stock Incentive Plans

In 2010, the Company adopted the Foundation Medicine, Inc. 2010 Stock Incentive Plan (the “2010 Stock Plan”) under which it granted restricted stock, incentive stock options (“ISOs”) and non-statutory stock options to eligible employees, officers, directors and consultants to purchase up to 1,162,500 shares of common stock. In the year ended December 31, 2013, the Company amended the 2010 Stock Plan to increase the number of shares of common stock available for issuance to 4,232,500.

In 2013, in conjunction with its initial public offering, the Company adopted the Foundation Medicine, Inc. 2013 Stock Option and Incentive Plan (the “2013 Stock Plan”) under which it may grant restricted and unrestricted stock, restricted stock units, ISOs, non-statutory stock options, stock appreciation rights, cash-based awards, performance share awards and dividend equivalent rights to eligible employees, officers, directors and consultants to purchase up to 1,355,171 shares of common stock. In connection with the establishment of the 2013 Stock Plan, the Company terminated the 2010 Stock Plan and the 512,568 shares which remained available for grant under the 2010 Stock Plan were included in the number of shares authorized under the 2013 Stock Plan. Shares forfeited or repurchased from the 2010 Stock Plan are returned to the 2013 Stock Plan for future issuance. On January 1, 2018 and 2017, the number of shares reserved and available for issuance under the 2013 Stock Plan increased by 1,461,671 and   1,403,616 shares of common stock, respectively, pursuant to a provision in the 2013 Stock Plan that provides that the number of shares reserved and available for issuance will automatically increase each January 1, beginning on January 1, 2014, by 4% of the number of shares of common stock issued and outstanding on the immediately preceding December 31 or such lesser number as determined by the compensation committee of the Board.  

23


 

The terms of stock award agreements, including vesting requirements, are determined by the Board, or pe rmissible designee thereof, subject to the provisions of the 2010 Stock Plan and the 2013 Stock Plan. Options, restricted stock, and restricted stock units granted by the Company typically vest over a four-year period. The options are exercisable from the date of grant for a period of 10 years. The exercise price for stock options granted is equal to the closing price of the Company’s common stock on the applicable date of grant.

Restricted Stock

For restricted stock, including restricted stock units, granted to employees, the intrinsic value on the date of grant is recognized as stock-based compensation expense ratably over the period in which the restrictions lapse. For restricted stock granted to non-employees, the intrinsic value is remeasured at each vesting date and at the end of the reporting period. The following table shows a roll forward of restricted stock activity pursuant to the 2010 Stock Plan and the 2013 Stock Plan:

 

 

 

Number of

Shares

 

Unvested at December 31, 2017

 

 

1,164,040

 

Granted

 

 

43,905

 

Vested

 

 

(207,016

)

Forfeited

 

 

(86,281

)

Unvested at March 31, 2018

 

 

914,648

 

Total stock-based compensation expense recognized for restricted stock awards was $2,997,000 and $5,639,000 for the three months ended March 31, 2018 and 2017, respectively.

Stock Options

A summary of stock option activity under the 2010 Stock Plan and the 2013 Stock Plan for the three months ended March 31, 2018 is as follows:

 

 

 

Number of

Shares

 

 

Weighted-

Average

Exercise

Price

 

 

Weighted-

Average

Remaining

Contractual

Term

(In Years)

 

 

Aggregate

Intrinsic

Value

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(in thousands)

 

Outstanding as of December 31, 2017

 

 

666,717

 

 

$

19.53

 

 

 

5.6

 

 

$

32,450

 

Granted

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercised

 

 

(184,783

)

 

 

18.56

 

 

 

 

 

 

 

 

 

Forfeited

 

 

(3,802

)

 

 

25.40

 

 

 

 

 

 

 

 

 

Outstanding as of March 31, 2018

 

 

478,132

 

 

$

19.86

 

 

 

5.3

 

 

$

28,159

 

Exercisable as of March 31, 2018

 

 

440,089

 

 

$

18.74

 

 

 

5.1

 

 

$

26,409

 

 

The Company recorded total stock-based compensation expense for stock options granted to employees, directors and non-employees from the 2010 Stock Plan and the 2013 Stock Plan of $211,000 and $760,000 for the three months ended March 31, 2018 and 2017, respectively.

The Company recorded stock-based compensation expense in the statements of operations and comprehensive loss as follows (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2018

 

 

2017

 

Cost of revenue

 

$

238

 

 

$

1,095

 

Selling and marketing

 

 

912

 

 

 

1,220

 

General and administrative

 

 

1,281

 

 

 

2,778

 

Research and development

 

 

777

 

 

 

1,306

 

Total

 

$

3,208

 

 

$

6,399

 

 

As of March 31, 2018, unrecognized compensation cost of approximately $23,510,000 related to non-vested stock options and restricted stock awards is expected to be recognized over weighted-average period o f 2.3 years.

24


 

 

15.

Commitments and Contingencies

Legal Matters

From time to time, we are a party to litigation arising in the ordinary course of its business. On July 28, 2017, a purported stockholder of the Company filed a putative class action in the U.S. District Court for the District of Massachusetts, against the Company and certain of its current and former executives, captioned Mahoney v. Foundation Medicine, Inc., et al. , No. 1:17-cv-11394. The complaint alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder based on allegedly false and misleading statements and omissions when providing 2015 financial guidance. The lawsuit seeks among other things, unspecified compensatory damages in connection with the Company’s allegedly inflated stock price between February 26, 2014 and November 3, 2015, interest, attorneys’ fees and costs, and unspecified equitable/injunctive relief.  On December 22, 2017, the plaintiffs filed an amended class action complaint alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder based on allegedly false and misleading statements and omissions concerning providing 2015 financial guidance and other statements during the class period concerning demand and reimbursement for certain of the Company’s tests.  On February 20, 2018, the Company moved to dismiss the complaint for failure to state a claim, which plaintiffs opposed on April 23, 2018. We believe this case is without merit and, therefore, continue to vigorously defend ourselves against the allegations.

 

16.

Related Party Transactions

Roche Holdings, Inc. and its affiliates

Related-party molecular information services revenue from Roche for the three months ended March 31, 2018 and 2017 was $14,648,000 and $5,504,000, respectively, which was earned under the Molecular Information Platform Program and Ex-U.S. Commercialization Agreement.

Related-party pharma research and development services revenue from Roche for the three months ended March 31, 2018 and 2017 was $1,467,000 and $4,143,000, respectively, from the reimbursement of R&D costs under the CDx Development, Immunotherapy Testing Platform Development and other programs.

Costs of related-party molecular information services from Roche were $5,948,000 and $900,000 for the three months ended March 31, 2018 and 2017, respectively, which consisted of costs incurred under the Molecular Information Platform Program and costs related to the delivery of services outside of the United States under the Ex-U.S. Commercialization Agreement.

At March 31, 2018, $9,099,000 and $4,801,000 was included in total accounts receivable and deferred revenue, respectively, related to this arrangement with Roche. At December 31, 2017, $10,159,000 and $3,742,000 was included in total accounts receivable and deferred revenue, respectively, related to this arrangement with Roche. As of March 31, 2018, the Company had $90 million in borrowings outstanding under the Roche Credit Facility. There were no other material Roche-related balances included in the condensed consolidated financial statements as of March 31, 2018 or December 31, 2017, or for the three months ended March 31, 2018 and 2017.

 

17.

Subsequent Events

On April 26, 2018, we announced a three-party collaboration with Roche and Dian Diagnostics Group, Co., Ltd. (“Dian”) to integrate our comprehensive genomic profiling (“CGP”) assays into clinical patient care in mainland China. Under the collaboration, Dian becomes the exclusive clinical sequencing partner in China for FoundationOne, FoundationACT and FoundationOneHeme, enabling the delivery of molecular information services by these tests for patients in China. Roche will maintain commercial exclusivity for our molecular information services in China, and in cooperation with Dian will continue its current in-county activities to support the broad integration of CGP into clinical care.

 

25


 

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

The following discussion of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and notes thereto appearing elsewhere in this Quarterly Report on Form 10-Q and the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2017. This discussion contains forward-looking statements that involve significant risks and uncertainties. As a result of many factors, such as those set forth under “Risk Factors” in Part II, Item 1A. of this Quarterly Report and our prior filings with the SEC, our actual results may differ materially from those anticipated in these forward-looking statements.

Overview

We are a molecular information company focused on fundamentally changing the way in which patients with cancer are evaluated and treated. We believe an information-based approach to making clinical treatment decisions based on comprehensive genomic profiling will become a standard of care for patients with cancer. We derive revenue from selling molecular information services that are enabled by our molecular information platform to physicians and biopharmaceutical companies. Our platform includes proprietary methods and algorithms for analyzing specimens across all types of cancer, and for incorporating that information into clinical care in a concise and user-friendly fashion. Our services provide genomic information about each patient’s individual cancer, enabling physicians to optimize treatments in clinical practice and biopharmaceutical companies to develop targeted oncology therapies more effectively. We believe we have a significant first mover advantage in providing a portfolio of comprehensive genomic profiling and molecular information services on a commercial scale.

Our clinical molecular information services, which include FoundationOne CDx, a U.S. Food & Drug Administration, or FDA, approved broad companion diagnostic assay for solid tumors, FoundationOne for solid tumors, FoundationOneHeme for blood-based cancers, or hematologic malignancies, and sarcomas, FoundationACT, a blood-based (liquid biopsy) assay to measure circulating tumor DNA, or ctDNA, and FoundationFocus CDx BRCA , an FDA-approved companion diagnostic assay to aid in identifying women with ovarian cancer for whom treatment with Rubraca™ (rucaparib) is being considered, are widely available comprehensive genomic profiles designed for use in the routine care of patients with cancer and in research.

Following the FDA’s approval of FoundationOne CDx in November 2017, the Centers for Medicare & Medicaid Services, or CMS, issued a final National Coverage Determination, or NCD, in March 2018 that establishes nationwide Medicare coverage for FoundationOne CDx for all solid tumor types when ordered by the patient’s treating physician for Medicare beneficiaries with advanced cancer ( i.e., either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer), who either have not been previously tested using FoundationOne CDx for the same primary diagnosis of cancer or are seeking repeat testing with FoundationOne CDx for a new primary cancer diagnosis, and continue to seek further cancer therapy.

To accelerate commercial growth and enhance our competitive advantage, we are continuing to develop and commercialize new molecular information services for physicians and biopharmaceutical companies, to strengthen our commercial organization, to introduce new marketing, education and provider engagement efforts, to grow our molecular information knowledgebase, FoundationCore, to pursue reimbursement from government payors and regional and national third-party commercial payors, to publish scientific and medical advances, and to foster relationships throughout the oncology community.

Since our inception in 2009, we have devoted substantially all of our resources to the development of our molecular information platform, the commercialization of FoundationOne, FoundationOneHeme, FoundationACT and FoundationFocus CDx BRCA , and the development of new services such as FoundationOne CDx. We have incurred significant losses since our inception, and as of March 31, 2018 our accumulated deficit was $525.5 million. We expect to continue to incur operating losses over the near term as we expand our commercial operations, including supporting the commercial launch of FoundationOne CDx, invest in our molecular information platform and additional services, and continue to scale our technology and data infrastructure.

FoundationOne, FoundationOneHeme, and FoundationACT have been commercialized as laboratory developed tests, or LDTs, which are subject to the Clinical Laboratory Improvement Amendments of 1988, or CLIA, and are not currently regulated as medical devices under the Federal Food, Drug and Cosmetic Act. FoundationFocus CDx BRCA and FoundationOne CDx are FDA-approved companion diagnostic assays. We believe our work developing companion diagnostic assays with our biopharmaceutical partners accelerates our progress in this area, and is a key component of our strategy and a significant differentiator for our business.

Recent Developments

On March 13, 2018, we and Guardant Health, Inc., or Guardant, announced an agreement to settle false advertising challenges that we and Guardant had filed against each other under the Lanham Act related to advertising for their respective liquid genomic profiling assays. Under the terms of the settlement, the lawsuit and counterclaims will be dismissed with prejudice. We and Guardant also agreed to create a rapid-resolution process in the event of further advertising-related disputes.

26


 

On March 16, 2018, we announced that Chugai Pharmaceutical Co., Ltd. , or C hugai , an affiliate of Roche, filed for regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for FoundationOne CDx in Japan . Pursuant to an agreement with Roche, Chugai will also lea d commercial efforts in Japan for FoundationOne CDx and our other comprehensive genomic profiling, or CGP , assays.

On March 18, 2018, we announced that the Centers for Medicare & Medicaid Services (CMS) issued a final National Coverage Determination (NCD) for patients who receive next generation sequencing (NGS) testing with an assay that meets the coverage criteria, including FoundationOne CDx. The final NCD establishes nationwide Medicare coverage for FoundationOne CDx for all solid tumor types when ordered by the patient’s treating physician for Medicare beneficiaries with advanced cancer ( i.e., either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer), who either have not been previously tested using FoundationOne CDx for the same primary diagnosis of cancer or are seeking repeat testing with FoundationOne CDx for a new primary cancer diagnosis, and continue to seek further cancer therapy.

On March 30, 2018, we announced commercial availability in the United States of FoundationOne CDx.

On April 11, 2018, we announced the presentation of new findings at the American Association for Cancer Research Annual Meeting. The data concerns the use of both tissue- and blood-based CGP to advance personalized cancer care and to inform the use of targeted and immunotherapy treatment approaches. Presentations included new data regarding the use of FoundationOne CDx, FoundationOne and FoundationACT,   and data regarding the use of our blood-based clinical trial assay to measure tumor mutational burden, or bTMB, as part of an investigational study now being conducted by an affiliate of Roche.

On April 26, 2018, we announced that the FDA granted a Breakthrough Device designation (formerly known as the Expedited Access Pathway program) for our new liquid biopsy assay.  This new assay, which is an expanded version of FoundationACT, is expected to include more than 70 genes, to incorporate multiple companion diagnostics and to include genomic biomarkers for microsatellite instability, or MSI, and bTMB, and will provide treating physicians with information helpful in determining the use of targeted oncology therapies, including immunotherapies.

On April 26, 2018, we announced a three-party collaboration with Roche and Dian Diagnostics Group, Co., Ltd., or Dian, to integrate our CGP assays into clinical patient care in mainland China. Under the collaboration, Dian becomes the exclusive clinical sequencing partner in China for FoundationOne, FoundationACT and FoundationOneHeme, enabling the delivery of molecular information services with these tests for patients in China. Roche will maintain commercial exclusivity for our molecular information services in China, and in cooperation with Dian will continue its current in-county activities to support the broad integration of CGP into clinical care .

On May 2, 2018, we announced a comprehensive gene expression profiling program to support precision oncology clinical research and development. This initiative will provide support for the Company’s biopharma partners in the efficient identification of known and novel genomic and expression-based biomarkers of response for investigational and approved personalized cancer therapies, including new and existing cancer immunotherapies.

Financial Operations Overview

Revenue

We derive revenue from the provision of molecular information services provided to our ordering physicians and biopharmaceutical customers, as well as from pharma research and development services provided to our biopharmaceutical customers. Molecular information services include molecular profiling and the delivery of other molecular information derived from our platform. Pharma research and development services include the development of new platforms and information solutions, including companion diagnostic development. We currently receive payments from commercial third-party payors, Medicare, certain hospitals and cancer centers with which we have direct-bill relationships, individual patients, and our biopharmaceutical customers.

Effective January 1, 2018, the Company began recognizing revenue in accordance with FASB ASC Topic 606,  Revenue from Contracts with Customers , or ASC 606. The Company adopted ASC 606 using the modified retrospective method of adoption, meaning the cumulative effect of applying ASC 606 has been recognized to accumulated deficit at January 1, 2018, the date of adoption of ASC 606, and prior comparative periods will not be recast to reflect ASC 606. As a result, revenue for the three months ended March 31, 2017 is presented in accordance with FASB ASC Topic 605, Revenue Recognition , or ASC 605, whereas revenue for the three months ended March 31, 2018 is presented under ASC 606. ASC 606 provides a five-step model for recognizing revenue 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.

27


 

Our clinical contracts included within molecular information services typically have a single performance obligation to transfer molecular profiling services to either a patient or a facility. In certain limited contracted scenarios , such as arrangemen ts with academic medical centers, the transaction price is stated within the contract and is therefore fixed consideration. For most of our clinical volume, we identified the patient as the customer in Step 1 of the model and have determined an implied contract exists with th e patient . As such, a stated contract price does not exist and the transaction price for each contract represents variable consideration. In developing the estimate of variable consideration, we utilize the expected value method unde r a portfolio approach. Our estimate requires significant judgement and is developed using historical reimbursement data from payo rs and patients , as well as known current reimbursement trends not r eflected in the historical data . As these contracts typica lly have a single performance obligation, no allocation of the transaction price is required in Step 4 of the model. M olecular information services are transferred to our ordering physician s at a point in time. Specifically, we determined the customer obta ins control of the promised service upon our delivery of the test results. Certain incremental costs, such as commissions, are incurred in obtaining clinical contracts. We have elected to utilize the practical expedient method to expense incremental costs of obtaining a contract that meet the capitalization criteria, as the amortization period of any contract acquisition asset would be one year or less due to the short-term nature of our clinical contracts.

For the majority of physician orders within the United States, the payment we ultimately receive depends upon the rate of reimbursement from commercial third-party payors and government payors. We are not currently a participating provider with most commercial third-party payors and, therefore, do not have specific coverage decisions from those third-party payors for our services with established payment rates. As a result, for most of our commercial third-party payors we are not a contracted provider and, therefore, do not have specific coverage decisions from those third-party payors for our specific services with established payment rates. Currently, most of the commercial third-party payors that reimburse our claims do so based upon Current Procedural Terminology, or CPT, codes, the predominant methodology, or based on other methods such as percentages of charges or other formulas that, to our knowledge are not specific to us, and are not made known to us. In addition, a small portion of commercial third-party payors outsource our claims to preferred provider organizations or third-party administrators, which entities process our claims and pay us directly at negotiated rates. Further, coverage and payment for reimbursement claims for our services are determined by each third-party payor on a case-by-case basis.

As of March 31, 2018, we were not a participating provider in any state Medicaid program, and therefore, did not have coverage determinations under which our tests were covered by these Medicaid programs. We are a participating provider in the Medicare program.

For tests that we offer that are not subject to an NCD, local Medicare Administrative Contractors, or MACs, that administer the Medicare program in various regions may, in their discretion but subject to Medicare rules, determine coverage, rates of reimbursement and payment.

The local MAC for our laboratory in Cambridge, Massachusetts is National Government Services which succeeded the previous local MAC NHIC, Corp., or NHIC.  In connection with the launch of FoundationOne, our first commercial test, and following discussions with NHIC, we agreed to not submit claims for FoundationOne tests provided to Medicare patients while NHIC assessed the appropriate coding, coverage, and payment for FoundationOne as a whole. To accommodate NHIC’s request, we deferred the submission of claims until November 2013, when we commenced the process of submitting claims to National Government Services for FoundationOne and FoundationOneHeme tests for Medicare patients with dates of service on or after November 1, 2013. We have submitted these claims for FoundationOne and FoundationOneHeme tests to National Government Services using a miscellaneous CPT code, and have not recognized revenue from Medicare for those claims to date. National Government Services, issued a final Local Coverage Determination, or LCD, effective April 1, 2016, to provide coverage for hotspot tests of 5 to 50 genes for patients with metastatic non-small cell lung cancer, or NSCLC. We do not believe this LCD reflects coverage for our CGP services, which include comprehensive analysis of greater than 50 genes and all classes of alterations. As of March 31, 2018, National Government Services has either denied the FoundationOne or FoundationOneHeme claims that we have submitted using stacked CPT codes, or not processed and reimbursed us for the claims in a manner that we believe is consistent with applicable processing guidelines. In August 2016, we began submitting claims for FoundationACT tests associated with our Cambridge, Massachusetts laboratory to National Government Services using stacked CPT codes, and as of March 31, 2018, we have recognized revenue from many of those claims .

The local MAC for our laboratory in Research Triangle Park, North Carolina, is Palmetto GBA, or Palmetto.  In May 2016, Palmetto issued a final LCD, or Palmetto LCD, to cover highly validated comprehensive genomic profiling received by Medicare patients initially diagnosed with Stage IIIB and Stage IV NSCLC and who otherwise meet the eligibility criteria of the Palmetto LCD.

In January 2017, we began submitting claims to Palmetto for FoundationOne test requisitions where components of our testing services were performed in our North Carolina facility. In March 2017, we began receiving payment for eligible NSCLC claims submitted under the Palmetto LCD based upon the allowable rate of $3,416 per test. In December 2016, Palmetto originally issued three draft LCDs for the use of comprehensive genomic profiling to guide treatment in patients with metastatic colorectal cancer, with metastatic melanoma, and with advanced primary peritoneal, fallopian tube and ovarian cancer, respectively. In March 2018, Palmetto re-issued revised versions of these draft LCDs, and is accepting public comments on such drafts until May 10, 2018.  If finalized as proposed, FoundationOne will be covered by Medicare when provided to patients with these conditions consistent with the terms of these LCDs.

28


 

In accordance with an exception to Medicare’s Date of Service rule , commonly known as the 14-Day Rule, for a subset of Medicare claim s we are required to bill the ordering institution directly instead of submitting claims to Medicare. We have recognized revenue associated with these bills upon receipt of payment from the institution .

We expect that our current lack of broad coverage decisions among commercial third-party payors, the fact that we are currently a contracted provider with only a few commercial third-party payors and the general uncertainty around reimbursement for our tests will continue to negatively impact our revenue and earnings. For Medicare tests we offer that are not subject to an NCD, a MAC having jurisdiction over any one of our laboratory facilities could issue a negative coverage determination for one or more of our tests that would apply to future claims for tests performed at the relevant facility and that MAC could defer processing claims pending a coverage or payment determination.

As of March 31, 2018, we had cash and cash equivalents of approximately $60.3 million. If we are not able to obtain additional coverage decisions over the longer term, and our available cash and cash equivalents balances, cash flows from operations, and available borrowings are insufficient to satisfy our liquidity requirements, we may require additional capital beyond our currently anticipated amounts. As of March 31, 2018, under the Credit Facility Agreement with Roche Finance Ltd dated August 2, 2016, as amended by the Amendment Letter Agreement with Roche Finance Ltd, dated July 31, 2017, or the Roche Credit Facility, we have $110 million of unused and available credit.  Additional capital may not be available on reasonable terms, or at all, and may be subject to the prior consent of Roche pursuant to the Roche Credit Facility and our Investor Rights Agreement with Roche dated January 11, 2015.

We also receive a small portion of revenue from patients who make co-payments and pay deductibles. In addition, while we take on the primary responsibility for obtaining third-party reimbursement on behalf of patients, including appeals for any initial denials, we bill patients for amounts that are determined to be due from the patient. We initiated the process to seek reimbursement from Medicare at the end of 2013, and as part of the Medicare reimbursement process, we seek advance beneficiary notices, or ABNs, from Medicare patients to enable us to bill a Medicare patient for all or part of a claim that is denied coverage by Medicare. We offer a comprehensive patient assistance program to provide financial support to patients whose incomes are below certain thresholds, and we also may allow for extended payment terms, as necessary, given the patient’s economic situation.

Our biopharma contracts included within molecular information services may include single or multiple performance obligations depending on the contract, and may include different molecular information service offerings, such as molecular profiling, provision of data through either database queries or subscription access to our platform, and clinical trial enrollment assistance, as separately identifiable from other promises in the contracts and therefore distinct performance obligations.

The transaction price in biopharma molecular information service contracts is typically fixed consideration. In certain instances, contracts may include variable consideration. In these contracts, variable consideration is estimated utilizing the expected value method. The primary method used to determine standalone selling price for the biopharma molecular information services is observable standalone selling price. When standalone selling price is not directly observable, the primary method used to estimate standalone selling price for molecular information services is the adjusted market assessment approach, under which we evaluate the market in which we sell the services and estimate the price that a customer in that market would be willing to pay for those services.

Control over biopharma molecular information services from molecular profiling and database queries is transferred to customers at a point in time. We determined the customer obtains control of the promised service upon delivery of the test results or the delivery of responses to database queries to the biopharma partner. Control over biopharma molecular information services from subscription access to our data platform is transferred to customers ratably over time. We determined that the customer obtains control of the promised service as we host the content throughout the contract term. Control over biopharma molecular information services from clinical trial enrollment assistance is transferred to customers ratably over time. We determined that the customer obtains control of the promised service as we stand ready to perform such services throughout the contract term.

Pharma research and development services may include single or multiple performance obligations dependent on the contract. Research and development, or R&D, services typically represent a single performance obligation as the Company performs a significant integration service for the individual goods or services in the research and development workstream, such as analytical validation and regulatory submissions. The individual promises are not separately identifiable from other promises in the contracts and, therefore, are not distinct. However, in certain contracts, a partner may engage the Company for multiple distinct R&D workstreams which are both capable of being distinct and separately identifiable from other promises in the contracts and, therefore, distinct performance obligations. Additionally, for regulatory contracts in pursuit of approval of a companion diagnostic assay, the Company identifies a performance obligation for commercial availability of the assay subsequent to obtaining regulatory approval.

The transaction price can consist of a combination of an upfront fee, performance-based development milestones, cost reimbursement, fixed per sample fees, commercial royalties, and commercial milestones. With the exception of upfront and fixed per sample fees, the other forms of compensation represent variable consideration. Variable consideration in the form of cost reimbursement and commercial royalties is estimated using the expected value method. Variable consideration in the form of development and commercial milestones is estimated using the most likely amount method. All variable consideration is constrained such that it is probable a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the

29


 

variable con sideration is subsequently resolved. Application of the constraint for variable consideration to milestone payments is an area that requires significant judgment. In making this assessment, the Company evaluates factors such as the scientific, clinical, re gulatory, commercial, and other risks that must be managed to achieve the respective milestone and the level of effort and investment required to achieve the respective milestone.

The primary method used to estimate standalone selling price for the R&D service performance obligations is the expected cost plus a margin approach, under which we forecast our expected costs of satisfying each performance obligation and then add an appropriate margin for that distinct good or service. The primary method used to estimate standalone selling price for a commercial availability performance obligation is the adjusted market assessment approach, under which we evaluate the market in which we sell the services and estimate the price that a customer in that market would be willing to pay for those services. The estimation of standalone selling price is an area that requires significant judgment, as it impacts the allocation objective in Step 4 of the model. Revenue will be recognized over time for R&D services and commercial availability services. Specifically, for R&D services we will recognize revenue using an input method to measure progress, utilizing costs incurred to-date relative to total expected costs as our measure of progress. For commercial availability services, we will recognize revenue using an input method to measure progress, resulting in a time-elapsed measure of progress.

The Company performs R&D services as part of its normal activities. The Company records these payments as Pharma research and development services revenue in the Consolidated Statements of Operations and Comprehensive Loss. The R&D costs incurred by the Company under these arrangements are included as Research and development expenses in the Company’s Consolidated Statements of Operations and Comprehensive Loss given these costs are related to the development of new services to be owned and offered by the Company to its customers.

Cost of Molecular Information Services Revenue and Operating Expenses

We allocate certain overhead expenses, such as rent, utilities, and depreciation to cost of molecular information services revenue and operating expense categories based on headcount and facility usage. As a result, an overhead expense allocation is reflected in cost of revenue and each operating expense category.

Cost of Molecular Information Services Revenue

Cost of molecular information services revenue generally consists of specific reagents, specific consumable lab supplies, and shared costs that are allocated to our molecular information services – our FoundationOne, FoundationOneHeme, FoundationACT and FoundationFocus CDx BRCA tests – either on a direct or indirect basis, resulting in an overall cost for each specific test. The shared costs that are allocated to each test include personnel expenses (comprised of salaries, bonuses, employee benefits and stock-based compensation expenses), depreciation of laboratory equipment and amortization of leasehold improvements, shipping costs, third-party laboratory costs, and certain overhead expenses. Costs associated with performing tests are recorded as tests are processed.

Cost of Related-Party Molecular Information Services Revenue from Roche

Cost of Related-party molecular information services revenue from Roche is generally derived by taking the cost per test described above and applying it to each of the FoundationOne, FoundationOneHeme and FoundationACT tests processed for Roche. Costs of Related-party molecular information services revenue from Roche are associated with performing molecular information services for Roche under both the (i) molecular information platform program within our R&D Collaboration Agreement with Roche, and (ii) our Ex-U.S. Commercialization Agreement with Roche. Revenues from tests performed by us under the molecular information platform and the Ex-U.S. Commercialization Agreement are recognized in the Related-party molecular information services from Roche caption within our Consolidated Statements of Operations and Comprehensive Loss.

Selling and Marketing Expenses

Our selling and marketing expenses include costs associated with our sales organization, including our direct sales force and sales management, client services, marketing, reimbursement, and business development personnel who are focused on our biopharmaceutical customers. These expenses consist principally of salaries, commissions, bonuses, employee benefits, travel, and stock-based compensation, as well as marketing and educational activities, and allocated overhead expenses. We expense all selling and marketing costs as incurred.

During the three months ended March 31, 2018 and 2017, our selling and marketing expenses represented approximately 33% and 62%, respectively, of our total revenue. We expect our selling and marketing expenses to continue to increase in absolute dollars as we grow our client service infrastructure, increase our marketing and medical affairs activities to drive further awareness and adoption of our current molecular information services, and any future services we may develop.

30


 

General and Administrative Expenses

Our general and administrative expenses include costs for our executive, accounting and finance, legal, corporate information technology, and human resources functions. These expenses consist principally of salaries, bonuses, employee benefits, travel, and stock-based compensation, as well as professional services fees such as consulting, audit, tax, legal and billing fees, general corporate costs, and allocated overhead expenses. We expense all general and administrative expenses as incurred.

We expect that our general and administrative expenses will continue to increase, primarily due to the costs associated with increased infrastructure and headcount. These costs include additional legal and accounting expenses, including ongoing litigation, and an increase in billing costs related to our anticipated increase in revenues.

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for the development of new and enhanced services, immunotherapy biomarker-testing, companion diagnostic development, significant service improvements, clinical trials to evaluate the clinical utility of our services, the development of our FoundationCore knowledgebase, and various technology applications such as FoundationSmartTrials. Costs to develop our technology capabilities are recorded as research and development unless they meet the criteria to be capitalized as internal-use software costs. Our research and development activities include the following costs:

 

personnel-related expenses such as salaries, bonuses, employee benefits, and stock-based compensation;

 

fees for contractual and consulting services;

 

costs to manage and synthesize our medical data and to expand FoundationCore;

 

clinical trials;

 

laboratory supplies; and

 

allocated overhead expenses.

Costs incurred for the performance of pharma research and development services requested by our biopharmaceutical customers, including non-molecular information services costs incurred under the R&D Collaboration Agreement with Roche, are included as research and development expenses in the Consolidated Statements of Operations and Comprehensive Loss, given these costs are related to the development of new services to be owned and offered by us to our customers. Revenues from these services are recognized in the Pharma research and development services and Related-party pharma research and development services from Roche captions within our Consolidated Statements of Operations and Comprehensive Loss.

Interest (Expense) Income, Net

Interest (expense) income, net includes interest expense and interest income. Interest expense consists primarily of the quarterly commitment fee on the available balance under the Roche Credit Facility and interest expense on outstanding borrowings under the Roche Credit Facility. Interest income is earned on our cash, cash equivalents, and marketable securities.

Other Income

Other income includes the gain on disposal of certain long-lived assets and foreign exchange transactions.

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Results of Operations

Comparison of Three Months Ended March 31, 2018 and 2017

 

 

 

Three Months Ended March 31,

 

 

Change

 

 

 

2018

 

 

2017

 

 

$

 

 

%

 

 

 

(in thousands, except percentages)

 

Statement of Operations Data:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Molecular information services

 

$

31,943

 

 

$

15,594

 

 

$

16,349

 

 

 

105

%

Related-party molecular information services from Roche

 

 

14,648

 

 

 

5,504

 

 

 

9,144

 

 

 

166

%

Pharma research and development services

 

 

4,782

 

 

 

1,087

 

 

 

3,695

 

 

 

340

%

Related-party pharma research and development services from Roche

 

 

1,467

 

 

 

4,143

 

 

 

(2,676

)

 

 

(65

)%

Total revenue

 

 

52,840

 

 

 

26,328

 

 

 

26,512

 

 

 

101

%

Costs and expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of molecular information services

 

 

21,279

 

 

 

17,117

 

 

 

4,162

 

 

 

24

%

Cost of related-party molecular information services from Roche

 

 

5,948

 

 

 

900

 

 

 

5,048

 

 

 

561

%

Selling and marketing

 

 

17,480

 

 

 

16,436

 

 

 

1,044

 

 

 

6

%

General and administrative

 

 

20,695

 

 

 

15,277

 

 

 

5,418

 

 

 

35

%

Research and development

 

 

23,859

 

 

 

23,285

 

 

 

574

 

 

 

2

%

Total costs and expenses

 

 

89,261

 

 

 

73,015

 

 

 

16,246

 

 

 

22

%

Loss from operations

 

 

(36,421

)

 

 

(46,687

)

 

 

10,266

 

 

 

22

%

Interest (expense) income, net

 

 

(994

)

 

 

90

 

 

 

(1,084

)

 

 

1204

%

Other income

 

 

 

 

 

144

 

 

 

(144

)

 

 

100

%

Net loss

 

$

(37,415

)

 

$

(46,453

)

 

$

9,038

 

 

 

19

%

Revenue

Molecular Information Services

Molecular information services revenue for the three months ended March 31, 2018 and 2017, respectively, were comprised of the following:

 

 

Three Months Ended March 31,

 

 

Change

 

 

 

2018

 

 

2017

 

 

$

 

 

%

 

 

 

(in thousands, except percentages)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Clinical:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Molecular information services

 

$

15,589

 

 

$

10,649

 

 

$

4,940

 

 

 

46

%

Related-party molecular information services from Roche

 

 

3,198

 

 

 

970

 

 

 

2,228

 

 

 

230

%

Total clinical revenue

 

 

18,787

 

 

 

11,619

 

 

 

7,168

 

 

 

62

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Pharma:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Molecular information services

 

 

16,354

 

 

 

4,945

 

 

 

11,409

 

 

 

231

%

Related-party molecular information services from Roche

 

 

11,450

 

 

 

4,534

 

 

 

6,916

 

 

 

153

%

Total pharma revenue

 

 

27,804

 

 

 

9,479

 

 

 

18,325

 

 

 

193

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total molecular information services revenue

 

$

46,591

 

 

$

21,098

 

 

$

25,493

 

 

 

121

%

32


 

Molecular information services revenue, including Roche related -p arty revenue, increased to $46.6 million for the three months ended March 31, 2018 from $21.1 million during the three months ended Mar ch 31, 2017 . Revenue from tests reported to our orde ring physicians increased to $18.8 million for the three months ended March 31, 2018 from $11.6 million for the three months ended March 31, 2017 . The increase in revenue was partly driven by the increase in the number of tests reported for patients located in the United States, Medicare payments for FoundationOne for eligible patients with NSCLC under the Palmetto LCD , and an increase in revenue recorded under our Roche Ex-U.S . Commercialization Agreement . The change to accrual basis revenue under ASC 606 was not the driver of the increase in revenue from tests reported to our ordering physicians, as cash basis clinical revenue under ASC 605 in the three months ended March 31, 2018 would have been approxim ately $22.0 million, inclusive of certain one-time catch up payments.

Molecular information services revenue from our biopharma customers increased to $27.8 million from $9.5 million for the three months ended March 31, 2018 and 2017, respectively, and was driven by increased testing volume from new and existing customers.

Related-party molecular information services revenue from Roche was $14.6 million and $5.5 million for the three months ended March 31, 2018 and 2017, respectively, the majority of which is revenue earned under the Molecular Information Platform Program and Ex-U.S. Commercialization Agreement.

During the three months ended March 31, 2018, we reported a total of 21,861 CGP tests for clinical use to ordering physicians, including 2,005 FoundationOneHeme tests, 2,123 FoundationACT tests, and 48 FoundationFocus CDx BRCA tests as compared to 13,933 tests reported during the three months ended March 31, 2017, including 1,284 FoundationOneHeme tests, 1,355 FoundationACT tests, and 289 FoundationFocus CDx BRCA tests.

For CGP tests delivered in the US for clinical use during the three months ended March 31, 2018, we estimate we will be paid on approximately 29% of these tests at an average rate of approximately $2,600 when paid. Despite our lack of broad coverage decisions across many commercial third-party payors, we have been partially successful in securing reimbursement from these payors. However, it is difficult to predict future reimbursement as a result of variable reimbursement payments and continuously developing coverage decisions.

We delivered the results of 7,184 and 1,802 tests to our biopharmaceutical customers during the three months ended March 31, 2018 and 2017, respectively, and the average revenue per test sold was approximately $3,200 and $3,500 for the same periods.

Pharma Research and Development Services

Pharma research and development services revenue, including Roche related-party revenue, increased to $6.2 million for the three months ended March 31, 2018 from $5.2 million during the three months ended March 31, 2017. The increase was primarily driven by revenue earned under R&D service agreements with our various biopharma partners. Pharma research and development services revenue under ASC 605 for the three months ended March 31, 2018 would have totaled approximately $2.3 million. The increase of approximately $3.9 million of revenue recorded under ASC 606 results from recognition during the quarter of companion diagnostic development services performed for a biopharma customer prior to achievement of the related contractual milestones. Under ASC 605, revenue recognition was limited by the right to invoice upon achievement of such milestones.

Related-party pharma research and development services for Roche includes related-party revenue from Roche of $1.5 million and $4.1 million for the three months ended March 31, 2018 and 2017, respectively. The decrease was primarily driven by a decrease in revenue earned under the Companion Diagnostic (CDx) Development Program and was not affected by the adoption of ASC 606.

Cost of Molecular Information Services

Cost of molecular information services revenue, including Roche related-party revenue, increased to $27.2 million for the three months ended March 31, 2018 from $18.0 million for the three months ended March 31, 2017. The increase was driven by a 57% increase in tests reported to our ordering physicians. Additional volume led to higher reagent and consumable costs, additional laboratory personnel-related costs and facilities costs, and higher depreciation expense related to new equipment purchases. During the three months ended March 31, 2018 and 2017, our total cost of molecular information services revenue represented approximately 58% and 85% of our total molecular information services revenue, respectively.

Cost of related-party molecular information services from Roche was $5.9 million and $0.9 million for the three months ended March 31, 2018 and 2017, respectively. The increase was primarily driven by an increase in the number of tests delivered under the Molecular Information Platform Program and Ex-US Commercialization Agreement.

33


 

Selling and Marketing Expenses

Selling and marketing expenses increased to $17.5 million for the three months ended March 31, 2018 from $16.4 million for the three months ended March 31, 2017. The increase was primarily due to an increase of $0.9 million in personnel-related costs for employees in our sales, marketing, client service and reimbursement departments to support our commercialization efforts, and a $0.2 million increase in rent and other facility costs.

General and Administrative Expenses

General and administrative expenses increased to $20.7 million for the three months ended March 31, 2018 from $15.3 million for the three months ended March 31, 2017. The increase was primarily due to an increase of $4.4 million in legal costs, and a $1.0 increase in rent and other facility costs.

Research and Development Expenses

Research and development expenses increased to $23.9 million for the three months ended March 31, 2018 from $23.3 million for the three months ended March 31, 2017. The increase was primarily attributed to a $2.2 million increase in personnel-related costs and $1.5 million in consulting related costs, offset by a $3.1 million decrease in laboratory supplies.

Interest (Expense) Income, Net

Interest expense was $1.2 million and $0.1 million for the three months ended March 31, 2018 and 2017, respectively. The increase was primarily related to interest incurred on the Roche Credit Facility which was first drawn on in the third quarter of 2017. Interest income was $0.2 million for both the three months ended March 31, 2018 and 2017.

Other Income

Other income during the three months ended March 31, 2017 was $0.1 million and related to a gain on disposal of certain long-lived assets and foreign exchange transactions.

Liquidity and Capital Resources

We have incurred losses and negative cash flows from operations since our inception in November 2009, and as of March 31, 2018, we had an accumulated deficit of $525.5 million.

We have funded our operations principally from the sale of common stock, preferred stock, borrowings under our credit facilities, and revenue from molecular information services and pharma research and development services. We have a limited number of coverage decisions for our existing tests from commercial third-party payors and have a limited history of collecting claims. We will continue to make requests for payment and/or appeal payment decisions made by commercial third-party payors. As of March 31, 2018, we had cash, cash equivalents, and restricted cash of approximately $62.6 million.

Pursuant to the Roche Credit Facility, which was amended on July 31, 2017, during the four-year period ending August 2, 2020, or the Draw Period, we may borrow up to $200 million. As of March 31, 2018, we have $90 million in borrowings outstanding and $110 million currently available under the facility. During the Draw Period, we are paying Roche Finance a quarterly commitment fee of 0.4% on the available balance of the Roche Credit Facility. Loans made under the Roche Credit Facility bear interest at 6.5% per annum. We are obligated to pay Roche Finance, quarterly during the Draw Period and for six months thereafter, accrued interest on the outstanding principal of the loans. Beginning six months after the Draw Period and for five years thereafter, we are obligated to pay Roche Finance quarterly equal payments of principal, with accrued interest, until maturity of the Roche Credit Facility on February 2, 2026.

34


 

Cash Flows

The following table sets forth the primary sources and uses of cash for each of the periods set forth below:

 

 

 

Three Months Ended March 31,

 

 

 

2018

 

 

2017

 

 

 

(in thousands)

 

Net cash used in operating activities

 

$

(38,892

)

 

$

(41,644

)

Net cash (used in) provided by investing activities

 

 

(5,682

)

 

 

25,531

 

Net cash provided by financing activities

 

 

33,430

 

 

 

1,571

 

Net decrease in cash, cash equivalents, and restricted cash

 

 

(11,144

)

 

 

(14,542

)

Effect of exchange rate changes on cash and cash equivalents

 

 

33

 

 

 

-

 

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

 

 

73,709

 

 

 

65,012

 

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

 

$

62,598

 

 

$

50,470

 

Operating Activities

Net cash used in operating activities in all periods resulted primarily from our net losses adjusted for non-cash charges and changes in components of working capital. The net cash used in operating activities was $38.9 million for the three months ended March 31, 2018 compared to $41.6 million for the three months ended March 31, 2017. The decrease in cash used in operating activities was driven primarily by a decrease in net loss of $9.0 million and a $0.9 million increase in depreciation and amortization expense partially offset by a $4.1 million increase in cash used for working capital and a decrease in stock-based compensation expense of $3.2 million.

Investing Activities

Net cash used in investing activities for the three months ended March 31, 2018 was $5.7 million and primarily consisted of purchases of property and equipment. Net cash provided in investing activities for the three months ended March 31, 2017 was $25.5 million and consisted of $34.4 million in proceeds received from maturities of marketable securities, partially offset by $5.0 million in purchases of marketable securities and other investments, and $3.9 million in purchases of property and equipment.

Financing Activities

Net cash provided by financing activities was $33.4 million for the three months ended March 31, 2018 and consisted of $30 million in cash borrowings under the Roche Credit Facility and $3.4 million in proceeds received from the exercise of stock options. Net cash provided by financing activities was $1.6 million for the three months ended March 31, 2017 and consisted solely of proceeds received from the exercise of stock options.

Operating Capital Requirements

We expect to incur additional operating losses in the near future and our operating expenses will increase as we seek regulatory approval of certain services, scale our technology infrastructure, expand our sales force, increase our marketing efforts to drive market adoption of our molecular information services, innovate our molecular information platform, and develop new service offerings. Our liquidity requirements have consisted of, and will continue to consist of, selling and marketing expenses, research and development expenses, capital expenditures, working capital and general corporate expenses. If demand for our services continues to increase, we anticipate that our capital expenditure requirements will also increase in order to build additional capacity. We expect that our planned expenditures will be funded from our ongoing operations, from our existing cash and cash equivalents, and borrowings under the Roche Credit Facility.

In April 2015, the Roche transaction was consummated, and we received $250.0 million in gross proceeds from the sale of 5,000,000 shares of our common stock to Roche at a price of $50.00 per share. On July 31, 2017, we amended the Roche Credit Facility. Pursuant to the Roche Credit Facility, as amended, during the Draw Period, we may borrow up to $200 million. We have currently borrowed $90 million and have immediate access to an additional $110 million. During the Draw Period, we shall pay Roche Finance a quarterly commitment fee of 0.4% on the available balance of the Roche Credit Facility. Loans made under the Roche Credit Facility bear interest at 6.5% per annum. We shall pay Roche Finance, quarterly during the Draw Period and for six months thereafter, accrued interest on the outstanding principal of the loans. Beginning six months after the Draw Period and for five years thereafter, we shall pay Roche Finance quarterly equal payments of principal, with accrued interest, until maturity of the Roche Credit Facility on February 2, 2026. Based on our current business plan, we believe our cash and cash equivalents as of March 31, 2018, the availability of borrowings under the Roche Credit Facility, and anticipated cash flows from operations will be sufficient to meet our

35


 

anticipated cash requirements for at least the next twelve months . We may consider raising additional capital to pursue strategic investments or for other reasons, subject to certain consent rights of Roche contained in the Investor Rights Agreement and the Roche Credit Facility. In the future, we expect our operating and capital expenditures to increase as we increase our headcount, expand our selling and marketing activities and continue to invest in new service offerings. If sales of our services grow, we expect our accounts receivable balance to increase. Any increase in accounts payable and accrued expenses may not comp letely offset increases in accounts receivable, which could result in greater working capital requirements.  

If our available cash balances, anticipated cash flow from operations, and available borrowings are insufficient to satisfy our liquidity requirements, including because of lower demand for our services, lower than currently expected rates of reimbursement from commercial third-party payors and government payors, increased competition from other providers of molecular diagnostic tests or other risks described in Part II, Item 1A. “Risk Factors” in this Quarterly Report and our prior filings with the SEC, we may seek to sell common or preferred equity or convertible debt securities, enter into another credit facility or another form of third-party funding. The sale of equity and convertible debt securities may result in dilution to our stockholders and those securities may have rights senior to those of our common stock. If we raise additional funds through the issuance of equity, convertible debt securities or other debt financing, these securities or other debt could contain covenants that would restrict our operations, and certain of these transactions will be subject to the prior consent of Roche as set forth in the Investor Rights Agreement and the Roche Credit Facility. Any other third-party funding arrangement could require us to relinquish valuable rights. We may require additional capital beyond our currently anticipated amounts. Additional capital may not be available on reasonable terms, or at all.

These estimates are forward-looking statements and involve risks and uncertainties and actual results could vary materially and negatively as a result of a number of factors, including the factors discussed in Part II, Item 1A. “Risk Factors” in this Quarterly Report and our prior filings with the SEC. We have based our estimates on assumptions that may prove to be wrong and we could utilize our available capital resources sooner than we currently expect. If we cannot expand our operations or otherwise capitalize on our business opportunities because we lack sufficient capital, our business, financial condition, and results of operations could be materially adversely affected.

Contractual Obligations and Commitments

The following summarizes our principal contractual obligations as of March 31, 2018 that have changed significantly since December 31, 2017 and the effects such obligations are expected to have on our liquidity and cash flow in future periods. Contractual obligations that were presented in our Annual Report on Form 10-K for the year ended December 31, 2017, but omitted below, represent those that have not changed significantly since that date.

 

 

Total

 

 

2018

 

 

2019-2020

 

 

2021-2022

 

 

Thereafter

 

 

 

(in thousands)

 

Long-term debt obligations (1)

 

 

90,000

 

 

 

-

 

 

 

-

 

 

 

31,500

 

 

 

58,500

 

Interest (1)

 

 

35,596

 

 

 

5,417

 

 

 

12,660

 

 

 

10,450

 

 

 

7,069

 

Total

 

$

125,596

 

 

$

5,417

 

 

$

12,660

 

 

$

41,950

 

 

$

65,569

 

(1)

We shall pay Roche Finance a quarterly commitment fee of 0.4% on the available balance of the Roche Credit Facility. Loans made under the Roche Credit Facility bear interest at 6.5% per annum. We shall pay Roche Finance, quarterly during the Draw Period and for six months thereafter, accrued interest on the outstanding principal of the loans. Beginning six months after the Draw Period and for five years thereafter, we shall pay Roche Finance quarterly equal payments of principal, with accrued interest, until maturity of the Roche Credit Facility on February 2, 2026. As of March 31, 2018, we had $90 million in borrowings outstanding under the Roche Credit Facility. For further details on the Roche Credit Facility, refer to footnote 11 in the Notes to the Condensed Consolidated Financial Statements .

Off-Balance Sheet Arrangements

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

Application of Critical Accounting Policies

We have prepared our consolidated financial statements in accordance with accounting principles generally accepted in the United States. Our preparation of these consolidated financial statements requires us to make estimates, assumptions, and judgments that affect the reported amounts of assets, liabilities, expenses, and related disclosures at the date of the consolidated financial statements, as well as revenue and expenses recorded during the reporting periods. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on 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 could therefore differ materially from these estimates under different assumptions or conditions.

36


 

There have been no material changes to our c ritical accounting policies from those described in Part II, Item 7. “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 , beyond the adoptio n of ASC 606 described in Note 2: Summary of Significant Accounting Policies.

Item 3. Quantitative and Qualitative Disclosures about Market Risks

There were no material changes during the three months ended March 31, 2018, with respect to the information appearing in Part II, Item 7A. “Quantitative and Qualitative Disclosures About Market Risk,” included in our Annual Report on Form 10-K for the year ended December 31, 2017.

Item 4. Controls and Procedures

Management’s Evaluation of our Disclosure Controls and Procedures

We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act) that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report. Based on this evaluation, our principal executive officer and principal financial officer have concluded that, as of March 31, 2018, our disclosure controls and procedures were effective at the reasonable assurance level.

We continue to review and document our disclosure controls and procedures, including our internal controls and procedures for financial reporting, and may from time to time make changes aimed at enhancing their effectiveness and to ensure that our systems evolve with our business.

Changes in Internal Control Over Financial Reporting

In the first quarter of 2018, we added and/or modified certain internal controls and processes in conjunction with adopting the new revenue recognition standard in January 2018 under the modified retrospective approach. These changes primarily relate to the implementation of accrual basis revenue recognition for our clinical molecular information services revenue, including identification of portfolios, estimation and constraint of variable consideration to support accrual estimates of revenue upon test delivery, and subsequent monitoring of cash collections to support re-estimation of variable consideration at each reporting period (changes in estimated transaction price). There have not been any additional changes in our internal control over financial reporting (as defined in Rule 13a‑15(f) and 15d‑15(f) of the Exchange Act) during the quarter ended March 31, 2018 that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.

37


 

PART II—OTHER INFORMATION

Item 1. Legal Proceedings

From time to time, we are a party to litigation arising in the ordinary course of its business. On July 28, 2017, a purported stockholder of the Company filed a putative class action in the U.S. District Court for the District of Massachusetts, against the Company and certain of its current and former executives, captioned Mahoney v. Foundation Medicine, Inc., et al. , No. 1:17-cv-11394. The complaint alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder based on allegedly false and misleading statements and omissions when providing 2015 financial guidance. The lawsuit seeks among other things, unspecified compensatory damages in connection with the Company’s allegedly inflated stock price between February 26, 2014 and November 3, 2015, interest, attorneys’ fees and costs, and unspecified equitable/injunctive relief.  On December 22, 2017, the plaintiffs filed an amended class action complaint alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder based on allegedly false and misleading statements and omissions concerning providing 2015 financial guidance and other statements during the class period concerning demand and reimbursement for certain of the Company’s tests.  On February 20, 2018, the Company moved to dismiss the complaint for failure to state a claim, which plaintiffs opposed on April 23, 2018. We believe this case is without merit and, therefore, continue to vigorously defend ourselves against the allegations .

Item 1A. Risk Factors

Investing in our common stock involves a high degree of risk. The risk factors described below pertain to us as of the date hereof and should be read in conjunction with the risk factors included in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2017. The risk factors included in this Quarterly Report and our Annual Report should be carefully considered although these risks are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business, financial condition or operating results. If any such risks or uncertainties actually occur, it could adversely affect our business, financial condition or results of operations, and could cause the market price of our common stock to fluctuate or decline.

Risks Relating to Our Business and Strategy

If one or more of our laboratory facilities become damaged or inoperable, if we are required to vacate any of our laboratory facilities, or if we are delayed in obtaining or unable to obtain additional laboratory space or delayed in commencing operations in our laboratory facilities, our ability to conduct our molecular information services, pursue our research and development efforts or our companion diagnostics partnerships, and fulfill our contractual obligations may be jeopardized.

Our revenue is primarily derived from testing services performed at our laboratory facilities. Our facilities and equipment could be harmed or rendered inoperable by natural or man-made disasters, including war, fire, earthquake, power loss, communications or internet failure or interruption, or terrorism, which may render it difficult or impossible for us to operate our molecular information platform for some period of time. The inability to perform our molecular tests or to reduce the backlog of analyses that could develop if one or more of our laboratories become inoperable, for even a short period of time, may result in the loss of customers or harm to our reputation, and we may be unable to regain those customers or repair our reputation in the future. Furthermore, our facilities and the equipment we use to perform our research and development work could be unavailable or costly and time-consuming to repair or replace. It would be difficult, time-consuming, and expensive to rebuild any of our facilities or license or transfer our proprietary technology to a third party, particularly in light of the licensure and accreditation requirements for commercial laboratories like ours. Even in the unlikely event we are able to find a third party with such qualifications to enable us to perform our molecular tests, we may be unable to negotiate commercially reasonable terms with such third parties. Adverse consequences resulting from an interruption of our overall laboratory operations could harm relationships with our customers and regulatory authorities, and our reputation, and could affect our ability to generate revenue.

We may also construct, acquire, or enter into relationships with third parties to procure additional laboratory space inside and outside the United States to support our existing and new tests. Our R&D Collaboration Agreement with Roche contemplates that we will collaborate with Roche on multiple programs related to the development of services for use in molecular information, immunotherapy, circulating tumor DNA, or ctDNA, and companion diagnostics and that we will provide additional laboratory space in Europe and Asia to perform genomic sequencing outside of the United States. In October 2017, our laboratory facility in Penzberg, Germany became operational. In April 2018, we announced our collaboration with Roche and Dian Diagnostics Group Co., Ltd., or Dian, pursuant to which Dian became the exclusive clinical sequencing partner in mainland China for FoundationOne, FoundationAct, and FoundationOneHeme to support Roche’s continued commercialization activities of our testing services in China. If our collaboration with Roche and Dian in China is unsuccessful, we are unable to obtain or are delayed in obtaining or establishing new laboratory space to support our commercialization and development efforts, or if our ex-United States laboratory operations are harmed or are rendered inoperable, we could fail to meet certain contractual obligations and agreed upon timelines with certain

38


 

biopharmaceutical partners, including R oche, or provide existing services and develop and launch new services in certain territories, which could result in harm to our business and reputation, and adversely affect our business, financial condition, and results of operations. As we continue to t ransition some of our services to new laboratories, we could experience disruptions in overall laboratory operations and could require adjustments to meet regulatory requirements, resulting in our inability to meet customer turnaround time expectations. An y delays in this transition could result in slower realization of laboratory efficiencies anticipated from operating an additional laboratory facility. Adverse consequences resulting from an interruption of our overall laboratory operations could harm rela tionships with our customers and regulators, and our reputation, and could affect our ability to generate revenue.

We carry insurance for damage to our property and laboratory and the disruption of our business, but this insurance may not cover all of the risks associated with damage to our property or laboratory or disruption to our business, may not provide coverage in amounts sufficient to cover our potential losses, may be challenged by insurers underwriting the coverage, and may not continue to be available to us on acceptable terms, if at all.

We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy.

We anticipate continued growth in our business operations both inside and outside the United States. Our laboratory facilities in North Carolina and Penzberg, Germany are operational, we have executed agreements to expand our facilities in Cambridge, Massachusetts, and we recently announced a collaboration with Roche and Dian to support Roche’s continued commercialization activities of our services in China. This expansion and any future growth could create strain on our organizational, administrative, and operational infrastructure, including laboratory operations, quality control, customer service, and sales force management. We may not be able to maintain the quality or expected turnaround times of our services or satisfy customer demand as it grows. Our ability to manage our growth properly will require us to continue to improve our operational, financial, and managerial controls, as well as our reporting systems and procedures. We plan to implement new enterprise software systems in a number of areas affecting a broad range of business processes and functional areas. The time and resources required to implement these new systems is uncertain, and failure to complete implementation in a timely and efficient manner could adversely affect our operations.

International expansion of our business exposes us to business, regulatory, political, operational, financial, and economic risks associated with doing business outside of the United States.

Our business strategy incorporates plans for significant international expansion through our collaboration with Roche. Pursuant to our Ex-U.S. Commercialization Agreement with Roche, in April 2016, Roche obtained the exclusive right to commercialize FoundationOne and FoundationOneHeme, in October 2017, the exclusive right to commercialize FoundationACT, and in February 2018, the exclusive right to commercialize FoundationOne CDx, in each case outside of the United States. Additionally, if terms are agreed upon between us and Roche, Roche may obtain the exclusive right to commercialize any new clinical diagnostic services developed under the R&D Collaboration Agreement, or upon mutual agreement any of our other services, in each case outside of the United States to the extent Roche has not elected to exclude any countries from its territory.

Our laboratory facility in Penzberg, Germany became operational in 2017. In addition, our Ex-U.S. Commercialization Agreement contemplates that we will provide laboratory space in Asia to perform genomic sequencing for FoundationOne, FoundationOneHeme, and FoundationACT. In April 2018, we announced our collaboration with Roche and Dian, pursuant to which Dian became our exclusive clinical sequencing partner in mainland China, to support Roche’s continued commercialization activities of our services in China.  Subject to satisfaction of certain performance milestones, the Ex-U.S. Commercialization Agreement will remain in effect until April 2020 and may be extended by Roche for additional two-year periods. Roche has the right to terminate the agreement without cause upon six months’ prior written notice after the initial five-year term, and either party may terminate the agreement in the event of breach by the other party. Since Roche has the exclusive right to commercialize FoundationOne, FoundationOneHeme, FoundationACT, FoundationOne CDx, and, if terms are agreed upon between us and Roche, any new clinical diagnostic services developed under the R&D Collaboration Agreement, our ability to achieve commercial success outside the United States, including growing test volume and revenue, obtaining coverage decisions from commercial and government payors, and developing and operating a sustainable international commercial infrastructure, relies to a significant extent on the performance of Roche.  

Doing business internationally involves a number of risks, including:

 

multiple, potentially conflicting, and changing laws and regulations such as data protection laws, privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements (including requirements related to patient consent, testing of genetic material, and reporting the results of such testing) and other governmental approvals, permits, and licenses, or government delays in issuing such approvals, permits, and licenses;

 

failure by us, Roche, or other authorized third parties to obtain and maintain regulatory approvals for the marketing, promotion, manufacture, sale, and use of our services in various countries;

 

transition and management of our former distribution relationships in various countries;

 

additional, potentially relevant third-party intellectual property rights;

39


 

 

complexities and difficulties in obtaining protection for and enforcing our intellectual property and defending ourselves against third-party claims of infringement of our intellectual property (including those elements of our intellectual property that we will make available to Dian as part of our collaboration with Roche and Dian in China), as the laws of some foreign jurisdictions, including China, may not provide sufficient protection of our intellectual property rights ;

 

difficulties in staffing and managing foreign operations or overseeing the staffing and management of foreign operations run by third parties;

 

complexities associated with obtaining reimbursement from and managing multiple payor reimbursement regimes, government payors, or patient self-pay systems;

 

logistics and regulations associated with preparing, shipping, importing, and exporting tissue and blood samples, including infrastructure conditions, transportation delays, and customs;

 

limits in our ability to penetrate international markets if we are not able to perform our molecular tests locally or, in the converse, if we are required to expend significant resources to establish infrastructure in such markets and/or perform our molecular tests locally in such markets;

 

financial risks, such as the impact of local and regional financial crises on demand and payment for our services, and exposure to foreign currency exchange rate fluctuations;

 

natural disasters, political, and economic instability, including wars, terrorism, and political unrest, outbreak of disease, boycotts, curtailment of trade, and other business restrictions; and

 

regulatory and compliance risks that relate to maintaining accurate information and control over sales and distribution activities that may fall within the purview of the United States Foreign Corrupt Practices Act, or FCPA, including its books and records provisions, or its anti-bribery provisions.

Any of these factors could significantly harm our future international expansion and operations and, consequently, our revenue and results of operations. The difference in regulations under United States law and the laws of foreign countries may be significant and, in order to comply with the laws of foreign countries, we may have to implement global changes to our services or business practices. Such changes may result in additional expense to us and either reduce or delay development of our services, commercialization, or sales. In addition, any failure to comply with applicable legal and regulatory obligations could impact us in a variety of ways that include, but are not limited to, significant criminal, civil, and administrative penalties, including imprisonment of individuals, fines and penalties, denial of export privileges, seizure of shipments, and restrictions on certain business activities. Also, the failure to comply with applicable legal and regulatory obligations could result in the disruption of our activities in these countries.

Our international operations could be affected by changes in laws, trade regulations, labor and employment regulations, and procedures and actions affecting approval, services, pricing, reimbursement, and marketing of our services, as well as by inter-governmental disputes. Any of these changes could adversely affect our business.

Our success internationally will depend, in part, on our ability to develop and implement policies and strategies that are effective in anticipating and managing these and other risks in the countries in which we do business. Failure to manage these and other risks may have a material adverse effect on our operations in any particular country and on our business as a whole.

Reimbursement and Regulatory Risks Relating to Our Business

If commercial third-party payors or government payors fail to provide coverage or adequate reimbursement, or if there is a decrease in the extent of coverage or amount of reimbursement for our existing services or any future services we develop, our revenue and prospects for profitability would be harmed.

Overview

In both domestic and many international markets, sales of our existing and any future services we develop will depend, in large part, upon the availability of adequate reimbursement from third-party payors. These third-party payors include government healthcare programs in various markets, such as Medicare and Medicaid in the United States, managed care providers, accountable care organizations, private health insurers, and other organizations. We believe that obtaining a positive Medicare Local Coverage Determination, or LCD, or National Coverage Determination, or NCD, and a favorable Medicare reimbursement rate, and obtaining the agreement of established commercial third-party payors to provide coverage and adequate payment, for each of our existing services, and any future services we develop, across substantially all medically indicated cancers will be a necessary element in achieving material commercial success. Physicians may not order our services unless commercial third-party payors and government payors authorize coverage and pay for all, or a substantial portion, of the rates established for our services.

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Commercial third-party payors and government payors are increasingly attempting to contain healthcare costs by lowering reimbursement rates, limiting cover age of diagnostic services, and creating conditions of reimbursement, such as requiring participation in clinical evidence development involving research studies and the collection of physician decision impact and patient outcomes data. Certain commercial third-party payors may not agree to reimburse our existing services or future services if CMS or the Medicare administrative contractors, or MACs, assigned to the jurisdictions in which our operational laboratory facilities are located do not issue positiv e coverage decisions, and pay for, such services. As a result of these cost-containment trends, commercial third-party payors and government payors that currently provide, or in the future may provide, reimbursement for one or more of our services may prop ose and/or actually reduce, suspend, revoke, or discontinue payments or coverage at any time. Payors may also create conditions for coverage or may contract with third-party vendors to manage laboratory benefits, in both cases creating administrative hurdl es for ordering physicians and patients that may make our services more difficult to sell. The percentage of submitted claims that are ultimately paid, the length of time to receive payment on claims, and the average reimbursement of those paid claims is l ikely to vary from period to period.

There is significant uncertainty surrounding whether the use of services that incorporate new technology, such as our portfolio of molecular information services, will be eligible for coverage by commercial third-party payors and government payors or, if eligible for coverage, what the reimbursement rates will be for these services. The fact that a diagnostic service has been approved for reimbursement in the past, has received FDA approval, or has obtained coverage for any particular indication or in any particular jurisdiction, does not guarantee that such diagnostic service will remain covered and/or reimbursed or that similar or additional diagnostic services and/or clinically indicated tumor types will be covered and/or reimbursed in the future. We have had claims for reimbursement denied by certain commercial third-party payors, in some cases because they have designated some or all of FoundationOne, FoundationOneHeme, and FoundationACT as experimental and investigational. Reimbursement of next generation sequencing, or NGS, -based cancer tests by commercial third-party payors and government payors may depend on a number of factors, including a payor’s determination that our existing and future services are:

 

not experimental or investigational;

 

medically reasonable and necessary;

 

appropriate for the specific patient;

 

cost effective;

 

supported by peer-reviewed publications;

 

included in clinical practice guidelines and pathways; and

 

supported by clinical utility and health economic studies demonstrating improved outcomes and cost effectiveness.

As a result, our efforts to pursue coverage on behalf of patients will take a substantial amount of time, and various commercial third-party payors and government payors may never cover or provide adequate payment for our existing and future services. Our strategy to achieve broad reimbursement and coverage is focused on demonstrating the clinical utility and economic benefits of our services, including engagement with key members of the oncology community and increasing physician demand, but there is no assurance that we will succeed in any of these areas or that, even if we do succeed, we will receive favorable coverage and reimbursement decisions. If adequate third-party coverage and reimbursement are unavailable, we may not be able to maintain volume and price levels sufficient to realize an appropriate return on investment in research and development. Furthermore, if a commercial third-party payor or government payor denies coverage and payment, it may be difficult for us to collect from the patient, and we may not be successful in doing so.

Government Payors

In the second quarter of 2016, the FDA and CMS accepted FoundationOne CDx for the Parallel Review program. The Parallel Review program provides concurrent review of a medical device by the FDA for marketing approval and by CMS for an NCD to facilitate patient access to innovative medical devices. In November 2017, the FDA approved FoundationOne CDx for detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability and tumor mutational burden, using DNA isolated from formalin-fixed paraffin embedded tumor tissue specimens. FoundationOne CDx is intended as a companion diagnostic for patients with metastatic non-small cell lung cancer, or NSCLC, melanoma, colorectal cancer, ovarian cancer, or breast cancer to identify those patients who may benefit from treatment with one of 17 on-label targeted therapies in accordance with FDA-approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with solid malignant neoplasms.

Following FDA’s approval of FoundationOne CDx in November 2017, CMS issued a final NCD in March 2018 that establishes nationwide Medicare coverage for FoundationOne CDx for all solid tumor types when ordered by the patient’s treating physician for Medicare beneficiaries with advanced cancer ( i.e. , either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer), who either have not been previously tested using FoundationOne CDx for the same primary diagnosis of cancer or are seeking repeat testing with FoundationOne CDx for a new primary cancer diagnosis, and continue to seek further cancer therapy. We

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cannot guarantee t hat the Medicare reimbursement rate established for this test will be favorable at the time of the initial rate determination or any time thereafter. If the Medicare reimbursement rate is unfavorable, we could experience a negative impact on revenue.

The final NCD establishes nationwide Medicare coverage NGS tests for advanced cancer that have been approved or cleared by the FDA as a companion diagnostic, and applies to all local MACs and Medicare Advantage plans. For NGS-based tests other than those that have been approved or cleared by the FDA as a companion diagnostic ( i.e., tests offered as LDTs or FDA-approved or cleared tests that are not a companion diagnostic), the final NCD allows the local MACs to continue determining coverage for such tests insofar as patients meet the patient criteria outlined in the final NCD ( i.e. , either recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer, and who either have not been previously tested using the same NGS test for the same primary diagnosis of cancer or are seeking repeat testing with the same NGS test for a new primary cancer diagnosis, and continue to seek further cancer therapy). As such, FoundationOne will continue to be covered by Medicare when provided to patients with NSCLC consistent with the current terms of the LCD issued by Palmetto GBA, or Palmetto. Palmetto is the MAC for the jurisdiction in which our North Carolina laboratory is located. The MolDx Program was developed by Palmetto to serve various functions, including establishing coverage and reimbursement for molecular diagnostic tests that fall under Palmetto’s purview. In May 2015, Palmetto’s MolDx Program published a final LCD, or the Palmetto LCD, which included reimbursement for comprehensive genomic profiles for highly validated testing in an initial subset of patients diagnosed with NSCLC. The Palmetto website listed FoundationOne as a covered test under this LCD effective October 1, 2015.

For tests we may offer that are not subject to an NCD, local MACs that administer the Medicare program in various regions have discretion in determining coverage for tests, subject to Medicare rules. A MAC assigned to a jurisdiction in which we have an operational laboratory facility may deny a claim submitted by us related to that facility. Even if we do receive coverage from a MAC on appeal of a denied claim, the reimbursement rate may be lower than we expect if the service is not currently priced on the Medicare Clinical Laboratory Fee Schedule, or CLFS, and if such rate is then adopted by commercial third-party payors, it would have an adverse effect on our revenues and results of operations. In addition, a MAC may, insofar as such determination is not inconsistent with an NCD, issue an LCD for one or more of our existing or future services, and/or for one or more clinically indicated tumor types involved with such services that would apply to future claims. Although we would have the opportunity to submit additional materials in support of a positive LCD for our services to the MAC (or to CMS through the Office of Medicare Hearings and Appeals for claims-level appeals), there is no guarantee that the MAC will provide us with any additional positive LCDs or claims decisions, reverse any previously issued negative LCDs or claims decisions, or maintain any previously issued positive LCDs. In circumstances of non-coverage under an NCD or LCD, we may be required to obtain a signed advance beneficiary notice, or ABN, from Medicare patients in order to be paid directly by the patient for non-covered services.

If CMS issues a negative NCD, or a MAC assigned to the jurisdiction in which one of our operational laboratory facilities is located issues a negative LCD, with respect to one or more of our services and/or clinically indicated tumor types, or if CMS under an NCD or a MAC under an LCD establishes patient eligibility conditions, data collection obligations or other requirements that are difficult and/or costly to satisfy, or if a MAC denies reimbursement of one or more of these services in claims not covered by an NCD or LCD, our revenue and results of operations would be adversely affected because we may not be able to satisfy such requirements, our costs in meeting reimbursement requirements may increase, or we will not receive revenue or will receive decreased revenue for tests performed. Similarly, if CMS or a MAC withdraws or negatively changes its coverage policies after deciding to cover one or more of our services, our revenue and results of operations would be adversely affected. Physicians may be less likely to order a test for a patient if the test is not subject to a positive coverage determination such that the patient could ultimately be responsible for all or substantially all of the cost of the test. We may also be less likely to receive a positive coverage determination by commercial third-party payors insofar as Medicare identifies one or more of our tests as non-covered in an NCD or LCD.

In September 2016, we began receiving test requisitions and samples from commercial customers at our North Carolina facility and performing components of FoundationOne and FoundationOneHeme testing at the facility. In accordance with CMS guidance, in January 2017, we began submitting an initial set of claims to Palmetto for FoundationOne test requisitions received in our North Carolina facility. We submitted these claims using miscellaneous Current Procedural Terminology, or CPT, codes with unique McKesson Z Code identifiers. In March 2017, we received our first payments for claims under the Palmetto LCD. Payment for all claims processed to date by Palmetto has been made based upon the allowable rate of $3,416 per test. Although we are performing components of our testing services for FoundationOneHeme in our North Carolina facility, Palmetto has provided guidance that CGP testing not covered by an LCD is explicitly non-covered, including FoundationOneHeme; therefore, we are seeking to obtain signed ABNs from Medicare patients who receive FoundationOneHeme testing. We are still in the process of determining what other types of services we may conduct at this facility. Such determination will be subject to the existence and limitations of applicable licenses and approvals, our ability to meet laboratory and testing requirements, and our ability to accommodate logistical and commercial needs in the test ordering and fulfillment process.

In parallel, we have been engaged in conversations with Palmetto regarding the potential for coverage and payment by Palmetto for FoundationOne claims submitted by our North Carolina laboratory for Medicare patients having tumor types other than NSCLC, as well as coverage and payment for testing. In December 2016, Palmetto originally issued three draft LCDs for the use of comprehensive genomic profiling to guide treatment in patients with metastatic colorectal cancer, with metastatic melanoma, and with

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advanced primary peritoneal, fallopian tube and ovarian cancer, respectively. In March 2018, Palmetto re-issued revised versions of these draft LCDs, and is accep ting public comments on such drafts until May 10, 2018.  If finalized as proposed, FoundationOne will be covered by Medicare when provided to patients with these conditions consistent with the terms of these LCDs. However, these draft LCDs may be delayed, may never be finalized, or if the LCDs are finalized, the coverage established by such LCDs may not result in payment for claims submitted by our North Carolina laboratory. There is no certainty that Palmetto will provide coverage for such Medicare patient s, and if coverage is provided, that such coverage will result in payments for claims submitted by our North Carolina laboratory. We are also currently seeking to obtain as part of the test order process a signed ABN from Medicare patients for non-covered tumor types in order to allow us to bill Medicare patients directly. The process of procuring signed ABNs may affect the turn-around-time for test report delivery, and may have a negative impact on test utilization, our revenue and our profitability .

Commercial Payors

We are currently considered an “out-of-network provider” by many commercial third-party payors because we have not entered into specific contracts to provide one or more of our existing services for their health plan beneficiaries, and as a result, patients may have higher out-of-pocket costs for our services and be subject to health plan requirements such as prior authorization. Physicians may be less likely to order our tests if patients have higher out-of-pocket costs or administrative hurdles, which would in turn have a negative effect on revenue and results of operations. If we were to become a contracted provider with additional commercial third-party payors in the future, the amount of overall reimbursement we receive may decrease if coverage is furnished for only a limited number of tumor types and/or we are reimbursed less money per test performed at a contracted rate than at a non-contracted rate, which could have a negative impact on our revenue. We may also be unable to collect patient out-of-pocket payments amounts directly from patients, and may experience lost revenue as a result. In addition, a payor’s decision to cover our services only in a specific tumor type such as NSCLC could also result in our inability to receive payment for other non-covered tumor types, resulting in lost volume and revenue. Finally, our contracts with current and any additional third-party payors will be subject to renewal, and the renewal process could result in lower reimbursement rates or elimination of reimbursement to us if the parties fail to agree to the terms of renewal and the contract is terminated.

Policy Considerations

The United States and foreign governments continue to propose and pass legislation designed to reduce the cost of healthcare. For example, in some foreign markets, the government controls the pricing of many healthcare services. We expect that there will continue to be federal and state proposals to implement governmental controls or impose healthcare requirements. In addition, the Medicare program and increasing emphasis on managed or accountable care in the United States will continue to put pressure on utilization and pricing. Utilization and cost control initiatives could decrease the volume of orders and payment that we would receive for any services in the future, which would limit our revenue and profitability.

Healthcare policy changes, including legislation reforming the United States healthcare system, may have a material adverse effect on our financial condition, results of operations, and cash flows.

Affordable Care Act

In March 2010, legislation collectively referred to as the Affordable Care Act, or ACA, was enacted in the United States. The ACA, as subsequently amended, made a number of substantial changes in the way healthcare is financed by both governmental and private insurers. Among other things, the ACA requires each medical device manufacturer and importer to pay an excise tax equal to 2.3% of the sale price for its taxable medical devices. In 2015, Congress imposed a two-year moratorium on this medical device tax, so that medical device sales during the period between January 1, 2016 and December 31, 2017 are exempt from the tax. In 2018, Congress extended the moratorium to medical device sales made during the period between January 1, 2018 and December 31, 2019. Absent further legislative action, the tax will be automatically reinstated for medical device sales starting on January 1, 2020. If the tax is reinstated, sales of our services that are regulated as medical devices, such as FoundationFocus CDx BRCA or FoundationOne CDx, would be subject to this tax.

On April 1, 2013, cuts to the federal budget were implemented, known as sequestration, resulting in a 2% annual cut in Medicare payments for all services, including clinical laboratory testing. Congress has since extended this 2% Medicare sequester through fiscal year 2025. At this time, it remains uncertain how long the cuts will be continued.

Many CPT procedure codes for molecular pathology tests that we use to bill our services were revised by the American Medical Association, or AMA, effective January 1, 2013. These new CPT codes were developed and implemented for individual genes, or the components of a multi-gene panel. In a final rule for calendar year 2013, CMS announced that it decided to keep the new molecular codes on the CLFS rather than move them to the Physician Fee Schedule. CMS then announced that for 2013, it would price the new codes using a “gap filling” process. Under this approach, CMS referred the CPT codes to the MACs to allow them to determine an appropriate price. CMS then calculated the median of the pricing provided by the MACs to establish and publish a National Limitation Amount, or NLA, by CPT code for 2014.

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In 2014, the AMA approved and implemented new CPT codes for genomic sequenc ing-based panel tests in cancer, effective January 1, 2015. In 2015, CMS used a “gap filling” process to price some of these new codes, which involved referring the new codes to the MACs to allow them to determine and submit to CMS an appropriate price. Fo r 2016, CMS established and published an NLA for some of these codes, including the code associated with testing for 5-50 genes as calculated by determining the me dian price as provided by the MACs for the applicable code. If CMS reduces reimbursement for the CPT codes for individual genes or fails to price favorably multi-gene panel codes upon which commercial payors may base rates, or if commercial payors who often base pricing on Medicare fee schedules reduce non-contracted payment rates below the NLA am ounts for CPT codes corresponding to individual genes, mandate use of the sequencing-based panel CPT codes, or decide to stop payment on specific CPT codes altogether, our revenue could be adversely affected. For 2018, CMS established and published an NLA for the CPT code associated with testing for over 51 genes as calculated based on the weighted me dian of the payment rates for private payors for such code.

Effective April 1, 2018, the AMA established a unique Proprietary Laboratory Analysis code that is specific to our FoundationOne CDx test. No Medicare payment rate has yet been established for this code.

Protecting Access to Medicare Act

In April 2014 the Protecting Access to Medicare Act of 2014, or PAMA, was enacted into law. Section 216 of PAMA reforms the Medicare payment system for clinical laboratory tests paid through the CLFS. PAMA establishes a market-based payment system for Medicare payment for clinical diagnostic laboratory tests. Under this new methodology, CMS will establish Medicare payment for each test based on the weighted median of the private payor rates for the test. PAMA also creates a new class of test called the Advanced Diagnostic Laboratory Test, or ADLT, defined as a test offered and furnished only by a single laboratory that is not sold for use by a laboratory other than the original developing laboratory and is either a (1) multi-biomarker test of DNA, RNA or proteins with a unique algorithm yielding a single, patient-specific result, (2) test that is cleared or approved by the FDA, or (3) test meeting other similar criteria established by the United States Secretary of Health and Human Services.

PAMA requires certain clinical laboratories meeting a threshold of Medicare revenues to report private payor rates and corresponding test volumes. We did not meet this threshold during the January 1, 2016 to June 30, 2016 data collection period and therefore were not required to report this data in 2017, however, we anticipate that we will be required to report data during future reporting periods. In June 2016, CMS issued the Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule, or the Final Rule, to implement the laboratory test payment provisions of PAMA. As outlined in the Final Rule, CMS implemented the new payment system on January 1, 2018. CMS has issued sub-regulatory guidance on data collection and reporting and on additional topics, including a list of specific billing codes for which laboratories must report data. In March 2018, CMS also published additional sub-regulatory guidance describing an application process for ADLTs. While we believe that FoundationOne CDx meets the requirements for designation as a new ADLT, it is possible that CMS will determine that FoundationOne CDx does not meet the requirements for classification as a new ADLT, or that the requirements of the ADLT application process could create delays for us submitting or billing under PAMA. A delay in or denial of an application for the designation of FoundationOne CDx as a new ADLT could materially change our approach to commercializing FoundationOne CDx and could negatively affect reimbursement and therefore revenue. Depending upon if and how commercial payors adopt, or are otherwise influenced by, this new Medicare pricing methodology and the payment rates, our average and weighted median commercial payor rate for our tests, including FoundationOne CDx, could be adversely affected.

The Center for Medicare and Medicaid Innovation announced in June 2016 the launch of the Oncology Care Model, or OCM, beginning on July 1, 2016. The OCM is a five-year voluntary program that includes 192 physician practices in 32 states, as well as 14 private payors. Under the OCM, participating practices receive performance based payments on the basis of how their prices for 6-month “episodes” of cancer care triggered by receipt of chemotherapy compare to “benchmark” prices for similar episodes. These benchmarks are based on the historical data for the period of January 2012 through June 2015. The model may impact the utilization of our tests among those practices participating in OCM.

Medicare 14-Day Rule

Certain Medicare billing policy requirements for clinical laboratory tests impact our ability to bill Medicare directly, and under certain circumstances, require us to bill and collect payments from hospitals for tests that we perform for inpatient or outpatient Medicare patients. Prior to January 1, 2018, under the so-called “14-Day Rule,” tests performed on specimens collected from hospital inpatients or outpatients, where those tests are ordered less than 14 days following the date of the patient's discharge from the hospital, could not be billed by us to Medicare directly; instead we had to bill the hospital for the test.

In November 2017, CMS finalized the 2018 Hospital Outpatient Prospective Payment System Final Rule, which allows us to directly bill Medicare more frequently. Specifically, under the revised billing rules, a laboratory that performs molecular pathology tests on specimens collected during a hospital outpatient stay may bill Medicare directly for such tests if the test was performed following a hospital outpatient's discharge from the hospital outpatient department. To the extent these revisions to Medicare’s billing policy permit us to bill Medicare directly for tests previously billed to hospitals under the 14-Day Rule, we will no longer bill hospitals for such tests. We continue to be subject to the 14-Day Rule, and therefore remain obligated to bill the hospital insofar as we

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perform tests on sp ecimens collected during a hospital inpatient stay. Hospitals may assert that they are not required to pay these bills, or they may delay in paying these bills. In these cases, for hospitals who disclaim responsibility for our bills or delay payment of our bills under the 14-Day Rule, we may undertake collection activities, and as a result of such efforts, we may accept payments from hospitals that are less than the original invoice or we may be unable to collect from hospitals any payments at all.  The man agement of this collection activity, and the acceptance of payment amounts less than the amount of such bills, involves a number of risks, including our ability to meet the requirements of applicable financial accounting principles and controls and healthc are regulations.  If we are not successful in managing this collection activity in a manner that meets our obligations, we could be deemed to be in violation of accounting principles or health care regulation, which in turn, could lead to the assertion of claims against us and a resulting adverse effect on our operating results and reputation .

Finally, the recent presidential and congressional elections in the U.S. could result in significant changes in, and uncertainty with respect to, legislation, regulation and government policy that could significantly impact our business and the healthcare industry. While it is not possible to predict whether and when any such changes will occur, a variety of initiatives to repeal or significantly reform key provisions of the ACA have been introduced in Congress or otherwise proposed. Most notably, Congress enacted legislation in 2017 that eliminates the ACA’s “individual mandate” beginning in 2019, which may significantly impact the number of covered lives participating in exchange plans. Other potentially significant changes in policy include the possibility of modifications and elimination of programs and reductions in staffing at the FDA and CMS, and initiatives to contain or reduce governmental spending in the healthcare area, including Medicare and Medicaid reimbursement. We cannot predict what future healthcare initiatives will be introduced or implemented at the federal or state level, or how any future legislation or regulation may affect us. Any taxes imposed by federal legislation and the expansion of the government’s role in the U.S. healthcare industry generally, as well as changes to the reimbursement amounts paid by payors for our existing and future services, may reduce our profits and have a material adverse effect on our business, financial condition, results of operations, and cash flows.

Risks Relating to Our Financial Condition and Capital Requirements

Changes in estimates as a result of the adoption of recently adopted financial accounting standards may cause an adverse impact to our reported results of operations.

In May 2014, the Financial Accounting Standards Board issued new revenue recognition rules under Accounting Standards Codification Topic 606, Revenue from Contracts with Customers , or ASC 606, which is effective for interim and annual periods beginning after December 31, 2017. We have adopted the new standard effective January 1, 2018 using the modified retrospective method. The adoption of ASC 606 is complex and requires the use of significant judgment in certain areas which could have a material effect on our financial statements.

In order to comply with the requirements of ASC 606, we added and/or modified certain internal controls and processes in the first quarter of 2018 in conjunction with adopting the new revenue recognition standard. In particular, accounting for clinical molecular information services revenue on an accrual basis under ASC 606 requires substantially more estimation by us as compared to recognizing revenue on a cash basis. This additional estimation could cause increased variability and uncertainty in our financial reporting and projections, which could have a material impact on our business. For example, accounting for clinical revenue on an accrual basis could result in true-ups in future periods as our reimbursement experience changes.

If we are not successful in our execution of the updated policies, procedures, information systems and internal controls over financial reporting which we implemented in the first quarter of 2018 to effectively record revenue under ASC 606, the revenue that we recognize and the related disclosures that we provide in our financial statements may not be complete or accurate, which could cause investors to lose confidence in our financial reporting, or cause us to fail to meet our reporting obligations, all of which could have an adverse effect on our reputation and operating results.

We have a history of net losses. We expect to incur net losses in the future and we may never achieve sustained profitability.

We have historically incurred substantial net losses, including a net loss of $161.5 million in 2017. From our inception in 2009 through March 31, 2018 , we had an accumulated deficit of $525.5 million. We expect our losses to continue as a result of not being broadly contracted with commercial payors, ongoing research and development expenses and increased selling and marketing costs. These losses have had, and will continue to have, an adverse effect on our working capital, total assets, and stockholders’ equity. Because of the numerous risks and uncertainties associated with our research, development, and commercialization efforts, we are unable to predict when we will become profitable, and we may never become profitable. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our inability to achieve and then maintain profitability would negatively affect our business, financial condition, results of operations, and cash flows.

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Risks Related to Our Common Stock

We are recently the subject of securities litigation, which could result in substantial costs and may divert our management’s attention.

From time to time, we are a party to litigation arising in the ordinary course of its business. On July 28, 2017, a purported stockholder of the Company filed a putative class action in the U.S. District Court for the District of Massachusetts, against the Company and certain of its current and former executives, captioned Mahoney v. Foundation Medicine, Inc., et al. , No. 1:17-cv-11394. The complaint alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder based on allegedly false and misleading statements and omissions when providing 2015 financial guidance. The lawsuit seeks among other things, unspecified compensatory damages in connection with the Company’s allegedly inflated stock price between February 26, 2014 and November 3, 2015, interest, attorneys’ fees and costs, and unspecified equitable/injunctive relief.  On December 22, 2017, the plaintiffs filed an amended class action complaint alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder based on allegedly false and misleading statements and omissions concerning providing 2015 financial guidance and other statements during the class period concerning demand and reimbursement for certain of the Company’s tests.  On February 20, 2018, the Company moved to dismiss the complaint for failure to state a claim, which plaintiffs opposed on April 23, 2018. We believe this case is without merit and, therefore, continue to vigorously defend ourselves against the allegations.

Item 6. Exhibits  

The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index, which is incorporated herein by reference.

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Exhibit

No.

 

Exhibit Index

 

 

 

10.1*#

 

Amended and Restated Ex-US Commercialization Agreement, by and between the Company and F. Hoffmann-La Roche Ltd, dated February 28, 2018.

 

10.2*

 

Executive Employee Offer Letter by and between the Company and Michael Doherty, dated December 5, 2016, as amended.

 

10.3*

 

Executive Employee Offer Letter by and between the Company and Konstantin Fiedler, dated May 1, 2018.

 

10.4*

 

Executive Employee Offer Letter by and between the Company and Melanie Nallicheri, dated September 12, 2016.

 

31.1*

 

Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 .

 

 

 

31.2*

 

Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 .

 

 

 

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.

 

 

 

101

 

Interactive Data Files regarding (a) our Condensed Consolidated Balance Sheets as of March 31, 2018 and December 31, 2017, (b) our Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three Months Ended March 31, 2018 and 2017, (c) our Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2018 and 2017, and (d) the Notes to such Condensed Consolidated Financial Statements.

 

 

 

 

*

Filed herewith.

**

Furnished herewith.

#        Confidential treatment has been requested or granted for certain information contained in this exhibit. Such information has been omitted and filed separately with the Securities and Exchange Commission.

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SIGNAT URES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf on the date set forth below by the undersigned thereunto duly authorized.

 

 

 

FOUNDATION MEDICINE, INC.

 

 

 

 

 

Date: May 2, 2018

 

By:

 

/s/ Troy Cox

 

 

 

 

Troy Cox

 

 

 

 

President and Chief Executive Officer

 

 

 

 

(Principal Executive Officer)

 

 

 

 

 

Date: May 2, 2018

 

By:

 

/s/ Jason Ryan

 

 

 

 

Jason Ryan

 

 

 

 

Chief Financial Officer

 

 

 

 

(Principal Financial Officer)

 

 

 

 

48

Exhibit 10.1

 

***Text Omitted and Filed Separately with the Securities and Exchange Commission

Confidential Treatment Requested Under

17 C.F.R. Sections 200.80(b)(4) and 240.24b-2

 

Execution Version

 

 

Amended and Restated

Ex-US Commercialization Agreement

 

 

This Amended and Restated Ex-US Commercialization Agreement is entered into as of February 28, 2018 ( the Restatement Date ”)

 

by and between

 

F. Hoffmann-La Roche Ltd

with an office and place of business at Grenzacherstrasse 124, 4070 Basel, Switzerland (“ Roche ”)

on the one hand

 

and

 

Foundation Medicine, Inc.

with an office and place of business at 150 Second Street, Cambridge, Massachusetts 02141

( FMI ”)

on the other hand.


***Confidential Treatment Requested***


 

Table of Contents

 

1.

Definitions

1

 

1.1

[…***…] Region

1

 

1.2

Affiliate

1

 

1.3

Agreement

2

 

1.4

Agreement Term

2

 

1.5

Allocable Overhead Expenses

2

 

1.6

Applicable Law

2

 

1.7

Business Day

2

 

1.8

Calendar Quarter

2

 

1.9

Calendar Year

3

 

1.10

Commercial Launch or Commercially Launch(ed)

3

 

1.11

Commercially Reasonable Efforts

3

 

1.12

Confidential Information

3

 

1.13

Control

3

 

1.14

Core Countries

4

 

1.15

Cost of Services

4

 

1.16

Cover

4

 

1.17

Critical Core Countries

4

 

1.18

Dedicated Sales Force

4

 

1.19

Effective Date

5

 

1.20

EMA

5

 

1.21

EU

5

 

1.22

Existing Third Party Rights

5

 

1.23

FDA

5

 

1.24

FMI Know-How

5

 

1.25

FMI Patent Rights

5

 

1.26

FMI Territory

5

 

1.27

FMI Trademarks

5

 

1.28

FTE

5

 

1.29

GAAP

5

 

1.30

Gross Margin

5

 

1.31

HSR

5

 

1.32

IFRS

6

 

1.33

Initial Filing

6

 

1.34

Initial Launch

6

 

1.35

Insolvency Event

6

 

1.36

Invention

6

 

1.37

JMC

6

 

1.38

JOC

6

 

1.39

Know-How

6

 

1.40

MSL

6

 

1.41

Net Sales

6

 

1.42

[…***…] Region

7

 

1.43

Non-Regulated Market

7

 

1.44

[…***…] Region

7

 

1.45

Party

7

 

1.46

Patent Rights

7

 

1.47

Post Approval Plan

7

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1.48

Product

7

 

1.49

Quality Standards

8

 

1.50

Region

8

 

1.51

Regulated Market

8

 

1.52

Regulatory Approval

8

 

1.53

Regulatory Authority

8

 

1.54

Roche Group

8

 

1.55

Roche Region

8

 

1.56

Sales

9

 

1.57

Sublicensee

9

 

1.58

Subsequent Claim Filing

9

 

1.59

Tactical Plan

9

 

1.60

Territory

10

 

1.61

Territory Revision Event

10

 

1.62

Third Party

10

 

1.63

Transitional Services Agreement

10

 

1.64

US

10

 

1.65

US$

10

 

1.66

Additional Definitions

10

2.

Licenses and Exclusivity

13

 

2.1

Licenses

13

 

2.2

Exclusive Right to Commercialize Products

13

 

2.3

Product Specifications; Modifications

14

3.

Right to Include Future Products

14

4.

Governance

15

 

4.1

Joint Management Committee

15

 

4.2

Joint Operational Committee

15

 

4.3

Members

15

 

4.4

Responsibilities of the JOC

15

 

4.5

Meetings

16

 

4.6

Minutes

16

 

4.7

Decisions

17

 

4.8

Information Exchange

17

 

4.9

Joint Operational Teams

17

 

4.10

Alliance Director

17

 

4.11

Limitations of Authority

18

 

4.12

Expenses

18

 

4.13

Lifetime

18

5.

Supply

18

6.

Regulatory

19

 

6.1

Responsibility

19

 

6.2

Clinical Trials

22

 

6.3

Reporting Adverse Events

23

 

6.4

Reimbursement

23

7.

Commercialization

24

 

7.1

Strategies

24

 

7.2

Sales

24

 

7.3

F1CDx Initial Launch Plan, Subsequent Claim Filings, and Non-Regulated Updates

24

 

7.4

Additional Responsibilities

26

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7.5

Branding and Pricing

31

 

7.6

Product Promotional Materials and Promotional Obligations

31

 

7.7

F1CDx Report

31

8.

Payment

32

 

8.1

General

32

 

8.2

Costs of Services

32

 

8.3

Royalty Payments and Sales Milestones

33

 

8.4

Disclosure of Payments

36

9.

Accounting and Reporting

36

 

9.1

Timing of Payments

36

 

9.2

Late Payment

36

 

9.3

Method of Payment

36

 

9.4

Currency Conversion

36

 

9.5

Reporting

36

10.

Taxes

36

11.

Auditing

37

 

11.1

Right to Audit

37

 

11.2

Audit Reports

37

 

11.3

Over-or Underpayment

37

 

11.4

Duration of Audit Rights

38

12.

Intellectual Property

38

 

12.1

Ownership of Inventions

38

 

12.2

Trademarks and Labeling

38

 

12.3

Prosecution of Patent Rights

39

 

12.4

Patent Coordination Team

39

 

12.5

Infringement

39

 

12.6

Defense

39

 

12.7

Common Interest Disclosures

39

13.

Representations and Warranties

39

 

13.1

FMI Representations and Warranties

39

 

13.2

Mutual Representations of the Parties

40

14.

Indemnification

41

 

14.1

Indemnification by Roche

41

 

14.2

Indemnification by FMI

41

 

14.3

Procedure

42

15.

Liability

42

 

15.1

Disclaimer

42

16.

Obligation Not to Disclose Confidential Information

42

 

16.1

Non-Use and Non-Disclosure

42

 

16.2

Permitted Disclosure

42

 

16.3

Press Releases

42

 

16.4

Publications

43

 

16.5

Commercial Considerations

43

17.

Term and Termination

44

 

17.1

Commencement and Term

44

 

17.2

Termination

44

 

17.3

Consequences of Termination and Expiration

45

 

17.4

Survival

48

18.

Bankruptcy

48

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19.

Miscellaneous

49

 

19.1

Governing Law

49

 

19.2

Disputes

49

 

19.3

Arbitration

49

 

19.4

Assignment

50

 

19.5

Compliance with Applicable Law

50

 

19.6

Debarment

51

 

19.7

Independent Contractor

51

 

19.8

Unenforceable Provisions and Severability

51

 

19.9

Waiver

51

 

19.10

Appendices

51

 

19.11

Entire Understanding

52

 

19.12

Amendments

52

 

19.13

Invoices

52

 

19.14

Notice

52

 

19.15

Subcontractors

52

 

19.16

Force Majeure

53

 

19.17

Rules of Construction

53

 

 

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Amended and Restated Ex-US Commercialization Agreement

 

 

WHEREAS, FMI has certain products that it currently commercializes, and additional products that it would like to commercialize in the future , either by itself or through a collaborator ;

 

WHEREAS, Roche has expertise in the commercialization of pharmaceutical and diagnostic products; and

 

WHEREAS, pursuant to that certain Ex-Us Commercialization Agreement, effective as of April 7, 2015 (as amended, the “ Original Agreement ”), Roche and FMI agreed to collaborate on the commercialization of certain FMI products outside of the US;

 

WHEREAS, concurrently with the Original Agreement, Roche and FMI entered into that certain transaction agreement which provided, among other things, for Roche to acquire a majority ownership of FMI upon the terms and subject to the conditions set forth therein (as it may be amended from time to time, the “ Transaction Agreement ”); a related investor rights agreement (as it may be amended from time to time, the “ Investor Rights Agreement ”); that certain United States education collaboration agreement pursuant to which Roche agreed to work with FMI in the United States to educate relevant persons on next generation sequencing and/or comprehensive genomic profiling technology (as it may be amended from time to time, the “ US Education Collaboration Agreement ”); that certain collaboration agreement pursuant to which Roche agreed to collaborate with FMI on the development of genomic testing platforms (as it may be amended from time to time, the “ Collaboration Agreement ”); and that certain master IVD collaboration agreement pursuant to which Roche and FMI agreed to establish a framework for a collaboration to develop, manufacture, distribute, and commercialize IVD Kit Products (as defined  therein) (as it may be amended from time to time, the “ Master IVD Collaboration Agreement ” and, together with the US Education Collaboration Agreement and the Collaboration Agreement, the “ Related Agreements ”);

 

WHEREAS, FMI and Roche intend that assays and other products generated under the Collaboration Agreement will be commercialized in accordance with this Agreement ; and

 

WHEREAS, FMI and Roche desire to amend and restate the Original Agreement in its entirety;

 

NOW, THEREFORE, in consideration of the mutual covenants and promises contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as follows:

 

1.

Definitions

As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:

 

1.1

[…***…] Region

The term “[…***…] Region” shall mean the […***…].

 

1.2

Affiliate

The term “Affiliate” shall mean any individual, corporation, association or other business entity that directly or indirectly controls, is controlled by, or is under common control with the Party in question. As used in this definition of “Affiliate,” the term “control” shall mean the direct or indirect ownership of more than fifty percent (>50%) of the stock having the right to vote for directors thereof or the ability to otherwise control the management of the corporation or other business

***Confidential Treatment Requested***


 

entity whether through the ownership of voting securities, by contract, resolution, regulation or otherwise. Anything to the contrary in this paragraph notwithstanding, Chugai Pharmaceutical Co., Ltd, a Japanese corporation (“Chugai”), shall not be deemed an Affiliate of Roche unless Roche provides written notice to FMI of its desire to include Chugai as an Affiliate of Roche. Moreover, FMI and its Affiliates existing as of the Restatement Date shall not be deemed Affiliates of Roche and its Affiliates existing as of the Restatement Date, and Roche and its Affiliates existing as of the Restatement Date shall not be deemed Affiliates of FMI and its Affiliates existing as of the Restatement Date. Affiliates coming into existence after the Restatement Date shall be classified by the Parties as either Roche Affiliates or FMI Affiliates for the purposes of this Agreement.

 

1.3

Agreement

The term “Agreement” shall mean this document including any and all appendices and amendments to it as may be added and/or amended from time to time in accordance with the provisions of this Agreement.   

 

1.4

Agreement Term

The term “Agreement Term” shall mean the period of time commencing on the Effective Date and, unless this Agreement is terminated sooner as provided in Article 17, expiring five (5) years from the Effective Date (“ Initial Term ”) unless extended by Roche in writing at least […***…] prior to the expiration of the Initial Term (or any Renewal Term) (i) in its entirety, (ii) on a country-by-country, Region by Region and/or Product-by-Product basis, or (iii) by mutual agreement of the Parties, in each case for additional two (2) year periods (each a “ Renewal Term ”) during any period of time in which the Aggregate Ownership Percentage (as defined in the Investor Rights Agreement) of Roche and its Affiliates is at least 50.1% (it being understood that this requirement is subject to Section 4.04 of the Investor Rights Agreement).

 

1.5

Allocable Overhead Expenses

The term “Allocable Overhead Expenses” shall mean costs incurred by a Party for its account which are attributable to the Party’s supervisory, services, occupancy costs, corporate bonus (to the extent not charged directly to department), and its payroll, information systems, human relations or purchasing functions and which are allocated to company departments based on space occupied or headcount or other activity-based method. Allocable Overhead Expenses shall not include any costs attributable to general corporate activities including executive management, investor relations, business development, legal affairs and finance.

 

1.6

Applicable Law

The term “Applicable Law” shall mean any law, statute, ordinance, code, rule or regulation that has been enacted by a government authority (including without limitation, any Regulatory Authority) and is in force as of the Effective Date or comes into force during the Agreement Term, in each case to the extent that the same is applicable to the performance by the Parties of their respective obligations under this Agreement.

 

1.7

Business Day

The term “Business Day” shall mean 9:00 a.m. to 5:00 p.m. local time on a day other than a Saturday, Sunday or bank or other public or federal holiday in Switzerland, New Jersey or Massachusetts.

 

1.8

Calendar Quarter

The term “Calendar Quarter” shall mean each period of three (3) consecutive calendar months, ending March 31, June 30, September 30, and December 31.

 

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1.9

Calendar Year

The term “Calendar Year” shall mean the period of time beginning on January 1 and ending December 31, except for the first Calendar Year of the Agreement Term, which shall begin on the Effective Date and end on December 31.

 

1.10

Commercial Launch or Commercially Launch(ed)

The term “Commercial Launch” or “Commercially Launch(ed)” shall mean a commercial launch of a particular Product, which shall at a minimum require at least commercial scale sales, marketing and promotional activities using Commercially Reasonable Efforts.   

 

1.11

Commercially Reasonable Efforts

The term “Commercially Reasonable Efforts” shall mean such level of efforts required to carry out such obligation in a sustained manner consistent with the efforts that Roche or FMI, as applicable, devotes at the same stage of development or commercialization, as applicable, for its own products with similar market potential, at a similar stage of their product life taking into account the existence of other competitive products in the market place or under development, the proprietary position of the product, the regulatory structure involved, the anticipated profitability of the product and other relevant factors. It is understood that such product potential may change from time to time based upon changing scientific, business and marketing and return on investment considerations.

 

1.12

Confidential Information

The term “Confidential Information” shall mean any and all information, data or know-how (including Know-How), whether technical or non-technical, oral or written, that is disclosed by one Party or its Affiliates (“ Disclosing Party ”) to the other Party or its Affiliates (“ Receiving Party ”). Confidential Information shall not include any information, data or know-how that:

 

 

(i)

was generally available to the public at the time of disclosure, or becomes available to the public after disclosure by the Disclosing Party other than through fault (whether by action or inaction) of the Receiving Party or its Affiliates,

 

(ii)

can be evidenced by written records to have been already known to the Receiving Party or its Affiliates prior to its receipt from the Disclosing Party,

 

(iii)

is obtained at any time lawfully from a Third Party under circumstances permitting its use or disclosure,

 

(iv)

is developed independently by the Receiving Party or its Affiliates as evidenced by written records other than through knowledge of Confidential Information, or

 

(vi)

is approved in writing by the Disclosing Party for release by the Receiving Party.

 

The terms of this Agreement shall be considered Confidential Information of the Parties.

 

1.13

Control

The term “Control” shall mean (as an adjective or as a verb including conjugations and variations such as “Controls” “Controlled” or “Controlling”) (a) with respect to Patent Rights and/or Know-How, the possession by a Party of the ability to grant a license or sublicense of such Patent Rights and/or Know-How without violating the terms of any agreement or arrangement between such Party and any other party and (b) with respect to proprietary materials, the possession by a Party of the ability to supply such proprietary materials to the other Party as provided herein without violating the terms of any agreement or arrangement between such Party and any other party.

 

 

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1.14

Co re Countries

The term “Core Countries” shall mean […***…].  The term “Core Countries” may be updated, without further amendment to this Agreement, to include additional countries approved by the JOC.

 

1.15

Cost of Services

The term “Cost of Services” means, as applicable to a Product, FMI’s costs incurred in connection with sample preparation, sequencing, data analysis, medical curation and report generation for such Product (collectively, “ Service Activities ”), equal to […***…]. The Cost of Services shall be calculated in accordance with GAAP or IFRS, as applicable , and as consistently applied by FMI in preparing its audited consolidated financial statements. FMI shall be solely responsible for all capital costs incurred in connection with providing the Service Activities for Products for use in the Territory, including without limitation building out capacity for such Products, provided that depreciation for any equipment used to provide the Service Activities will be included in the Cost of Services to the extent allocable to a Product in a manner consistent with FMI’s internal and external accounting principles as consistently applied. Except as provided for in Section 8.2 , Cost of Services will not include any transfer pricing mark-up. For clarity, any given deduction utilized in calculating Cost of Services (including the components thereof) shall be taken only once.

 

Notwithstanding the foregoing, to the extent the Parties have agreed to other calculations for the Cost of Services in a given country in the Territory, the Cost of Services in such country in the Territory shall be governed by the separate terms agreed to between the Parties.

 

1.16

Cover

The term “Cover” shall mean (as an adjective or as a verb including conjugations and variations such as “Covered,” “Coverage” or “Covering”) that the developing, making, using, offering for sale, promoting, selling, exporting or importing of a given compound, formulation or product would infringe a valid claim in the absence of a license under the Patent Rights to which such valid claim pertains. The determination of whether a compound, formulation, process or product is covered by a particular valid claim shall be made on a country-by-country basis. As used in the previous sentence, “valid claim” means, with respect to a particular country a claim in an issued and unexpired patent that has not lapsed or been disclaimed, revoked, held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal and that has not been admitted to be invalid or unenforceable through re-examination, re-issue, disclaimer or otherwise, or lost in an interference proceeding.

 

1.17

Critical Core Countries

The term “Critical Core Countries” shall mean […***…].  The term “Critical Core Countries” may be updated, without further amendment to this Agreement, to include additional countries approved by the JOC.

 

1.18

Dedicated Sales Force

The term “Dedicated Sales Force” shall mean a Roche sales force promoting F1CDx that (i) does not promote, and is prohibited from promoting, any oncology therapeutics and (ii) is not directly, on an individual basis or on a Roche sales force promoting F1CDx basis, compensated or financially incentivized by sales of oncology therapeutics.

 

 

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1.19

Effective Date

The term “Effective Date” shall mean the effective date of the Collaboration Agreement.

 

1.20

EMA

The term “EMA” shall mean the European Medicines Agency or any successor agency with responsibilities comparable to those of the European Medicines Agency.

 

1.21

EU

The term “EU” shall mean the European Union and all its then-current member countries.

 

1.22

Existing Third Party Rights

The term “Existing Third Party Rights” shall mean any Third Party rights granted by FMI to such Third Party relating to the Products in the Territory under an agreement with FMI existing as of the Effective Date. The Existing Third Party Rights are listed in Appendix 1.22.

 

1.23

FDA

The term “FDA” shall mean the US Food and Drug Administration.

 

1.24

FMI Know-How

The term “FMI Know-How” shall mean the Know-How that FMI Controls at the Effective Date and during the Agreement Term.

 

1.25

FMI Patent Rights

The term “FMI Patent Rights” shall mean the Patent Rights that FMI Controls Covering a Product or its use.

 

1.26

FMI Territory

The term “FMI Territory” shall mean (i) the US, and (ii) any countries that have been removed from the Territory pursuant to the terms of this Agreement.

 

1.27

FMI Trademarks

The term “FMI Trademarks” shall mean all trademarks Controlled by FMI which are necessary or useful for use in connection with the commercialization of Products.

 

1.28

FTE

The term “FTE” shall mean a full-time equivalent person-year, based upon a total of no less than one thousand eight hundred (1,800) working hours per year . In no circumstance can the work of any given person exceed one (1) FTE.

 

1.29

GAAP

The term “GAAP” shall mean US generally accepted accounting principles .

 

1.30

Gross Margin

The term “Gross Margin” shall mean Net Sales minus Cost of Services.

 

1.31

HSR

The term “HSR” shall mean the Hart-Scott-Rodino Antitrust Improvements Act.

 

 

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1.32

IFRS

The term “IFRS” shall mean International Financial Reporting Standards.

 

1.33

Initial Filing

The term “Initial Filing” shall mean the initial filing for the F1CDx platform in a Regulated Market to obtain Regulatory Approval for such product.

 

1.34

Initial Launch

The term “Initial Launch” shall mean : (a) as it relates to a Regulated Market, the Commercial Launch of F1CDx in such country following an Initial Filing and (b) as it relates to a Non-Regulated Market, the Commercial Launch of F1CDx in such country following delivery of FMI’s F1CDx Launch Notice.

 

1.35

Insolvency Event

The term “Insolvency Event” shall mean circumstances under which a Party (i) has a receiver or similar officer appointed over all or a material part of its assets or undertaking; (ii) passes a resolution for winding-up (other than a winding-up for the purpose of, or in connection with, any solvent amalgamation or reconstruction) or a court makes an order to that effect or a court makes an order for administration (or any equivalent order in any jurisdiction); (iii) enters into any composition or arrangement with its creditors (other than relating to a solvent restructuring); (iv) ceases to carry on business; (v) is unable to pay its debts as they become due in the ordinary course of business.

 

1.36

Invention

The term “Invention” shall mean an invention that is made, i.e. , conceived and reduced to practice, in performance of activities under this Agreement.

 

1.37

JMC

The term “JMC” shall mean the joint management committee described in Article 6 of the Collaboration Agreement. If the Collaboration Agreement terminates before this Agreement, then the provisions of the Collaboration Agreement to the necessary to interpret or implement this Agreement shall be incorporated by reference into this Agreement.

 

1.38

JOC

The term “JOC” shall mean the joint operating committee as mentioned in the Collaboration Agreement and the US Education Collaboration Agreement, and described in Section 4.2.

 

1.39

Know-How

The term “Know-How” shall mean data, knowledge and information, including chemical manufacturing data, toxicological data, pharmacological data, preclinical data, assays, platforms, formulations, specifications, quality control testing data, that are necessary or useful for the discovery, manufacture, development or commercialization of Products.

 

1.40

MSL

The term “MSL” shall mean a medical science liaison.

 

1.41

Net Sales

The term “Net Sales” shall mean, for a Product in a particular period, the amount calculated by subtracting from the Sales of such Product for such period: […***…].

 

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1.42

[…***…] Region

The “[…***…] Region” shall mean all countries in the Territory excluding the […***…] Region and the […***…] Region.

 

1.43

Non-Regulated Market

The term “Non-Regulated Market” shall mean a market other than a Regulated Market.

 

1.44

[…***…] Region

The term “[…***…] Region” shall mean […***…].

 

1.45

Party

The term “Party” shall mean FMI or Roche, as the case may be, and “Parties” shall mean FMI and Roche collectively.

 

1.46

Patent Rights

The term “Patent Rights” shall mean all rights under any patent or patent application, in any country of the Territory, including any patents issuing on such patent application, and further including any substitution, extension or supplementary protection certificate, reissue, reexamination, renewal, division, continuation or continuation-in-part of any of the foregoing.

 

1.47

Post Approval Plan

The term “Post Approval Plan” shall mean the plan for regulatory (including the strategy with respect to Regulatory Approvals and reimbursement approvals for Products) and clinical activities associated with a Product in the Territory.

 

1.48

Product

The term “Product” shall mean (i) the FoundationOne® clinical diagnostic testing commercial product (the “ FoundationOne Product ” or “ FoundationOne ”) and the FoundationOne® Heme clinical diagnostic testing commercial product (“ FoundationOne Heme ” and, together with FoundationOne, collectively, “ Initial Products ”), (ii) the FoundationACT® clinical diagnostic testing commercial product (“ FACT ”, and together with the Initial Products, collectively, the “ First Year Products ”), (iii) the FoundationOne CDx TM clinical diagnostic testing commercial product (“ FoundationOne CDx ” or “ F1CDx ”) and (iv) any other clinical diagnostic testing commercial products developed under the Immunotherapy Testing Platform Development Program (as defined in the Collaboration Agreement), the ctDNA Platform Development Program (as defined in the Collaboration Agreement), or the CDx Development Program (as defined in the Collaboration Agreement), including, to the extent developed under any such development program under the Collaboration Agreement, any product that becomes subject to a Regulatory Approval by a Regulatory Authority in the US after the Restatement Date (clause (iv), subject to the terms of Section 8.3.5, collectively, “ Collaboration Products ”) and (v) any other products that the Parties mutually agree to include under this Agreement.  The term “Product” shall include associated Service Activities provided in connection with Sales, […***…].  For clarity, […***…] are excluded from the definition of a Product.

 

For clarity, the term “clinical diagnostic testing commercial product” as used in this Agreement specifically excludes the provision of any testing products or services related to research and development activities, including any activities related to the sale of diagnostic testing products and services to biopharmaceutical companies, or genomic profiling for clinical trials sponsored or

 

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otherwise funded by biopharmaceutical companies.   Nothing herein will exclude sales to clinicians for market development purposes in connection with Commercially Launching a Product in the Territory, on terms that are mutually agreed to by the Parties.

 

1.49

Quality Standards

The term “Quality Standards” shall mean (i) FMI’s standard specifications in accordance with Section 2.3, with respect to the Products and performance of Service Activities, which shall include technical specifications on such Product and standards for the validation of such Product, and (ii) Clinical Laboratory Improvements Amendments (CLIA) or Quality Standard Regulations (QSR) requirements, each as applicable to a Product, and other standards required by Applicable Laws in the Territory.

 

1.50

Region

The term “Region” shall mean the […***…] Region, the […***…] Region, and the […***…] Region.

 

1.51

Regulated Market

The term “Regulated Market” shall mean a market in the Territory in which Regulatory Approval is required in order to manufacture, have manufactured, sell, have sold, market (including place on the market or put into service), have marketed, import or have imported all or any portion of F1CDx, including any companion diagnostic claims.

 

1.52

Regulatory Approval

The term “Regulatory Approval” shall mean any approvals (including, specifically in Japan, National Health Insurance price listing), licenses, registrations , authorizations , by any Regulatory Authority necessary to manufacture, have manufactured, sell, have sold, market (including place on the market or put into service) , have marketed, import or have imported any Product in the Territory.

 

1.53

Regulatory Authority

The term “Regulatory Authority” shall mean any national, supranational (e.g., the European Commission, the Council of the European Union, the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the EMA, in any country involved in the granting of Regulatory Approval for the Product.

 

1.54

Roche Group

The term “Roche Group” shall mean collectively Roche and its Affiliates and Sublicensees.

 

1.55

Roche Region

The term “ Roche Region ” shall mean each of […***…] (each as defined below in this Section 1.55).  

 

The “[…***…]” shall mean the country of […***…].

 

The “[…***…]” shall mean the country of […***…].

 

The “[…***…]” shall mean the countries of […***…].

 

The term “[…***…]” shall mean the countries […***…].

 

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The term […***…] shall mean the countries of […***…] .

 

The term “[…***…]” shall mean the countries of […***…].

For clarity, any countries listed in this Section 1.55 that are in the Territory but that the Parties have otherwise mutually agreed to exclude from the Virtual Gross Margin Calculation shall be excluded from the applicable Roche Region even if such country is otherwise listed in this Section 1.55.  Any countries in the Territory that are not otherwise listed in the definitions of the […***…], the […***…], the […***…], the […***…], the […***…], and the […***…] shall be assigned to a specific Roche Region by mutual agreement of the Parties.

 

1.56

Sales

The term “Sales” shall mean, for a Product in a particular period, the sum of (i) and (ii):

 

(i)

the amount stated […***…] for such period […***…]. This amount […***…] in such period reduced by […***…] taken in accordance […***…]:

 

 

[…***…]

 

 

[…***…]

 

 

[…***…]

 

[…***…]

 

 

[…***…]

 

For purposes of clarity, […***…] shall be excluded from “Sales”. Notwithstanding the foregoing, to the extent the Parties have agreed to other calculations for Sales in a given country in the Territory, the Sales in such country in the Territory shall be governed by the separate terms agreed to between the Parties.

 

(ii)

[…***…].

 

1.57

Sublicensee

The term “Sublicensee” shall mean a permitted entity to which Roche has licensed rights in accordance with Section 2.1.2 of this Agreement.

 

1.58

Subsequent Claim Filing

The term “Subsequent Claim Filing” shall mean any subsequent filing made following the Initial Filing to add any companion diagnostic claims to F1CDx not included in the Initial Filing, that requires Regulatory Approval, including any additional biomarkers added following the Initial Filing specifically in connection with the addition of any companion diagnostic claim included in such subsequent filing.

 

1.59

Tactical Plan

The term “Tactical Plan” shall mean the plan describing the tactics and logistics for marketing, promotion and sale of a Product in a specific country or Region, which shall address matters such as (i) annual minimum amounts of Product to be sold in such country or Region, (ii) details regarding the marketing support for the Products, and (iii) other activities to be conducted by either Party.

 

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1.60

Territory

The term “Territory” shall mean all countries of the world, excluding the FMI Territory.

 

1.61

Territory Revision Event

The term “Territory Revision Event” shall mean a Territory Revision Event 1, Territory Revision Event 2, Territory Revision Event 3, Territory Revision Event 4, Territory Revision Event 5, Territory Revision Event 6 or Territory Revision Event 7.

 

1.62

Third Party

The term “Third Party” shall mean a person or entity other than (i) FMI or any of its Affiliates or (ii) a member of the Roche Group.

 

1.63

Transitional Services Agreement

The term “Transitional Services Agreement” shall mean that certain transitional services agreement, effective as of December 1, 2016, by and between the Parties, pursuant to which FMI agreed to perform certain “Transitional Services” (as defined therein) for Roche in certain countries in the Territory.

 

1.64

US

The term “US” shall mean the United States of America and its territories and possessions.

 

1.65

US$

The term “US$” shall mean US dollars.

 

1.66

Additional Definitions

Each of the following definitions is set forth in the Section of this Agreement indicated below:

 

Definition

Section

AAA

19.3

AAA Arbitration Rules

19.3

Accounting Period

9.1

Adverse Event

6.3

Alliance Director

4.10

APAC Region

1.55

Arbitration Offer

8.3.5

Arbitration Commencement Date

8.3.5

Average Delivery Time Metric

7.4.2.3

Bankruptcy Code

18

Breaching Party

17.2.1

Chairperson

4.3

Chugai

1.2

Collaboration Agreement

Whereas clause

Collaboration Products

1.38

Dependent Obligation

7.4.1.5

Disclosing Party

1.12

[…***…]

1.55

[…***…]

1.55

 

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Definition

Section

Expert

8.3.5

F1CDx

1.48

F1CDx Initial Launch Plan

7.3.1

F1CDx Launch Notice

7.3.1

F1CDx Personnel

6.1.2.3

F1CDx Report

7.7

FACT

1.48

FCPA

19.5

Firewall

6.1.2.3

Firewall Policies

6.1.2.3

FMI

Cover page

FMI-Originated Transfer Activities

17.3.4.3

FoundationOne

1.48

FoundationOne CDx

1.48

FoundationOne Product

1.48

Global Cost

8.2.1

Global Test Fixed Fee

8.2.1

Indemnified Party

14.3

Indemnifying Party

14.3

Initial Discussion Period

8.3.5

Initial Launch Requirement

7.3.1

Initial Products

1.48

Initial Term

1.4

Investor Rights Agreement

Whereas clause

[…***…]

1.55

JOT

4.9

[…***…]

1.55

Local Cost

8.2.1

Local Test Fixed Fee

8.2.1

Master IVD Collaboration Agreement

Whereas clause

Material Average Delivery Time Failure

7.4.2.3

Members

4.3

Minimum Price

7.5

Minimum Revenue Requirements

7.4.1.2

Minimum Transfer Payment

17.3.4.3

NGS

7.4.2.3

Non-Breaching Party

17.2.2

Non-Regulated Update

7.3.2

[…***…]

1.55

Original Agreement

Whereas clause

Panel

8.3.5

Payment Currency

9.3

Penalty Payment

8.3.6

Peremptory Notice Period

17.2.2

Precedent Obligation

7.4.1.5

Product Documentation Requirements

7.4.1.4

 

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Definition

Section

Product Trademark s

12.2

Professional Services

7.7

Publishing Notice

16.4

Publishing Party

16.4

Qualified Sample

7.4.2.3

Quarterly Average Delivery Time Failure

7.4.2.3

Rebuttal

8.3.5

Receiving Party

1.12

Regulated Claims

7.7

Regulatory Partner

6.1.2.4

Regulatory Partner Notice

6.1.2.4

Related Agreements

Whereas clause

Renewal Term

1.4

Restatement Date

Cover page

Roche

Cover page

Roche Regulatory Support

6.1.2.4

Roche Transfer Activities

17.3.4.3

ROFN Negotiation Period

3

Royalty Term

8.3.1

Samples

17.3.4.3

Selected Agreement

8.3.5

Service Activities

1.15

Supporting Memorandum

8.3.5

Territory Revision Event 1

6.1.2.3

Territory Revision Event 2

6.1.2.4

Territory Revision Event 3

7.3.1

Territory Revision Event 4

7.3.1

Territory Revision Event 5

7.3.2

Territory Revision Event 6

7.4.1.4

Territory Revision Event 7

7.4.1.6

Third Party F1CDx Regulatory Information

6.1.2.3

Third Party Test Fee

8.2.2

Transaction Agreement

Whereas clause

Universal CDx Product

2.2

US Cost

8.2.1

US Education Collaboration Agreement

Whereas clause

Virtual Gross Margin Calculation

8.3.2.1

 

 

 

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2.

Licenses and Exclusivity

 

2.1

Licenses

2.1.1

Patents and Know-How

Subject to the terms and conditions of this Agreement, FMI hereby grants to Roche a right and license, including the right to sublicense solely as permitted in Section 2.1.2, under FMI’s interest in the FMI Patent Rights and FMI Know-How to use, have used, import, have imported, export, have exported, market, have marketed, distribute, have distributed, sell and have sold Products in the Territory. Subject to Section 2.2 and the other terms of this Agreement, the foregoing license shall be exclusive (even as to FMI).

 

2.1.2

Sublicenses

The licenses granted by FMI to Roche in Section 2.1.1 and 2.1.3 may be sublicensed by Roche to any Affiliate of Roche for so long as such Affiliate remains an Affiliate. Any such sublicense automatically terminates if such Affiliate Sublicensee ceases to be an Affiliate of Roche. In addition, the licenses granted by FMI to Roche in Section 2.1.1 and 2.1.3 (and any sublicense by Roche to an Affiliate of Roche) may be sublicensed (through one or more tiers) by Roche (and its Affiliates) to a Third Party (i) without the prior written consent of FMI in countries where Roche customarily utilizes such Third Party to conduct commercialization activities on behalf of Roche or its Affiliates or (ii) otherwise with the prior written consent of FMI, not to be unreasonably withheld. Roche shall be liable for any act or omission of any such Sublicensee that is a breach of any of Roche’s obligations under this Agreement as though the same were a breach by Roche, and FMI shall have the right to proceed directly against Roche without any obligation to first proceed against such Sublicensee.

2.1.3

Trademarks

Subject to the terms and conditions of this Agreement, FMI hereby grants to Roche a right and license, including the right to sublicense solely as permitted in Section 2.1.2, under FMI’s interest in the FMI Trademarks to use, have used, import, have imported, export, have exported, market, have marketed, distribute, have distributed, sell and have sold Products in the Territory. Subject to Section 2.2 and the other terms of this Agreement, the foregoing license shall be exclusive (even as to FMI).  Such trademark licenses shall be non-transferable, except that FMI shall have the right to sublicense such rights to its licensees in the FMI Territory, and Roche shall have the right to sublicense such rights to its permitted Sublicensees in the Territory.

 

2.2

Exclusive Right to Commercialize Products

S ubject to the terms of this Agreement , Roche and its Sublicensees shall have the exclusive right (even as to FMI) to market, distribute and sell Products in the Territory, subject to activities designated for FMI to conduct under a Tactical Plan approved by the JOC. To the extent applicable, the foregoing right shall be subject to the rights granted under the Existing Third Party Rights. If FMI receives any order from a prospective purchaser located in a country in the Territory, FMI shall promptly refer that order to Roche, and Roche shall process such order for such purchaser in the Territory in accordance with the terms of this Agreement. If Roche receives any order from a prospective purchaser located in the FMI Territory, then Roche shall promptly refer that order to FMI. The Parties will discuss an appropriate transition plan for the Existing Third Party Rights. At Roche’s request, and to the extent possible under the Existing Third Party Rights without incurring any termination fee, penalty or similar fee, FMI will terminate any or all of the

 

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Existing Third Party Rights. Notwithstanding the above, if there is any termination fee, penalty or similar fee, Roche shall have the right to pa y such termination fee, penalty or similar fee to terminate any or all of the Existing Third Party Rights. Moreover, Roche shall have the right, in coordination with FMI, to engage in negotiations with the Third Parties to which the Existing T hird Party Rights pertain, with the intent of allowing Roche to intervene to terminate such Existing Third Party Rights.

 

Unless otherwise agreed expressly by the Parties, for any companion diagnostic assay Product, that is also for use in indicating a therapeutic or referencing a clinical trial of a Third Party (“ Universal CDx Product ”), such Third Party shall have the right to recommend use of such Universal CDx Product in the Territory to the extent allowable under Applicable Law, including using or referencing such Universal CDx Product name, logo and trade dress in such Third Party therapeutics label, package insert, or in its promotional and regulatory materials.  Without limiting the foregoing, Third Parties with Regulated Claims on a Universal CDx Product, including F1CDx, in any country shall be permitted, to the extent permitted by Applicable Law, to recommend the use of and promote a Universal CDx Product, including F1CDx, to their customers, including as a companion diagnostic for such Third Party’s therapeutics.  To the extent that FMI enters into any in vitro diagnostic development agreement with any Third Party that contemplates a Regulated Claim on F1CDx in the Territory, and to the extent such Third Party desires to promote F1CDx in the Territory, FMI will include in its in vitro diagnostic development agreement with such Third Party an obligation that any promotion of F1CDx by such Third Party will comply with Applicable Laws and be consistent with the F1CDx brand and product messaging guidelines provided by FMI and the terms and conditions set forth in this Agreement.

 

2.3

Product Specifications; Modifications

Product specifications for the Initial Products as of the Effective Date are attached hereto as Appendix 2.3 and Product specifications for FACT and F1CDx as of the Restatement Date have been provided to Roche. FMI will develop product specifications for all other Products during development of each such Product.  FMI will provide a copy of draft product specifications for such Products to Roche for such Products as such specifications are substantially completed , except for any specifications that incorporate Third Party proprietary or confidential information.   FMI will provide a copy of any material modifications to any Product specifications (other than F1CDx) to Roche prior to such implementation.  FMI shall consider in good faith any and all comments or concerns timely raised by Roche in connection with its review of such draft specifications or such modifications (in each case, excluding Third Party confidential information relating to F1CDx).   FMI shall only be authorized to adopt modifications to the First Year Product specifications that result in a diminution to the analytical performance as measured by the metrics set forth in Appendix 2.3, either (i) with the prior written consent of Roche or (ii) without such consent if FMI has or is adopting the same modification to the specifications for the same Product as it has developed and commercialized in the US. In the event that clause (ii) above is applicable for an Initial Product, the JOC may reset the Minimum Revenue Requirement in such year in accordance with Section 7.4.1.2 .

 

3.

Right to Include Future Products

During the Agreement Term, Roche shall have a first right to negotiate with FMI to include in the Territory future clinical diagnostic testing commercial products Controlled by FMI (excluding (i) in vitro diagnostics kit products, (ii) any companion diagnostic assay products developed by FMI for a Third Party, and (iii) any standalone data or molecular information products (i.e. other than clinical diagnostic testing commercial products)), as a Product to market, distribute and sell in the Territory, on terms to be mutually agreed upon by the Parties. If FMI plans to Commercially Launch a clinical diagnostic testing commercial product in the Territory or grant such product

 

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rights to a Third Party, then FMI shall provide Roche with written notice of such plan and a copy of draft spec ifications for such Product . […***…] .

 

4.

Governance

 

4.1

Joint Management Committee

The roles and responsibilities of the JMC are set forth in the Collaboration Agreement.

 

4.2

Joint Operational Committee

The JOC serves to oversee all activities under this Agreement. The JOC will strive to reach consensus on any matters within its authority with each Party having one (1) vote. The JOC will reasonably consider all information, proposals and advice received from each Party in relation to the matters for which it has responsibility. Unresolved disputes at the JOC will be escalated to the JMC using the procedures outlined in the Collaboration Agreement.

 

4.3

Members

The JOC shall be composed of an equal number of persons from each Party (“ Members ”). Roche and FMI each shall be entitled to appoint three (3) Members with appropriate seniority and functional expertise, unless otherwise agreed by the Parties. Each Party may replace any of its Members and appoint a person to fill the vacancy arising from each such replacement. A Party that replaces a Member shall notify the other Party at least […***…] prior to the next scheduled meeting of the JOC. Both Parties shall use reasonable efforts to keep an appropriate level of continuity in representation. Both Parties may invite a reasonable number of additional experts and/or advisors to attend part of or the whole JOC meeting with prior notification to the JOC. Members may be represented at any meeting by another person designated by the absent Member. The JOC shall be chaired […***…], and then alternating between the Parties on a […***…] basis thereafter (“ Chairperson ”).

 

4.4

Responsibilities of the JOC

The JOC shall have the responsibility and authority to:

(a)

create and approve a transition plan for Existing Third Party Rights;

(b)

review and recommend for approval by the JMC Tactical Plans and Post Approval Plans for Products that Roche intends to Commercially Launch or has Commercially Launched;

(c)

review and recommend for approval by the JMC any revisions to the Tactical Plans and Post Approval Plans;

(d)

review and oversee execution of the Tactical Plans and Post Approval Plans;

(e)

establish timelines for the Commercial Launch of any Products and the marketing, distribution and sale of such Products;

(f)

identify appropriate resources necessary to conduct the Tactical Plans and Post Approval Plans;

(g)

create, oversee or disband JOTs as deemed appropriate;

(h)

establish and set expectations and mandates for JOTs, if applicable;

(i)

resolve disputes of the ESWG (as such term is defined in the US Education Collaboration Agreement) in accordance with Section 2.2.3 of the US Education Collaboration Agreement;

 

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(j)

monitor and implement plans to ensure adequate Product supply in the Territory;

(k)

review and approve product and corporate level branding for Products subject to Section 12.2 (Trademarks & Labeling);

(l)

[…***…];

(m)

review and recommend for approval by the JMC promotional materials outside of FMI’s approved guidelines;

(n)

review and recommend for approval by the JMC any clinical research for Products in the Territory; provided that the Parties may conduct clinical research without approval of the JMC in accordance with Section 6.2 (Clinical Trials);

(o)

[…***…];

(p)

recommend action items to its respective decision making bodies;

(q)

review Quality Standards and modifications thereto in accordance with Section 2.3 (Product Specifications and Modifications);

(r)

review customer service practices and performance in accordance with Section 7.4.1.6 (Customer Service);

(s)

review strategies for reimbursement approvals in accordance with Section 6.4 (Reimbursement);

(t)

review Average Delivery Time Metric in accordance with Section 7.4.2.3 (NGS Sequencing and Supply of Products and Service Activities) ;

(u)

agree upon the timeline for the Initial Launch of F1CDx in each country in the Territory and the other provisions of each F1CDx Initial Launch Plan;

(v)

discuss any changes to the F1CDx bait set following the Restatement Date;

(w)

assign countries in the Territory that are not part of the […***…], the […***…], the […***…], the […***…], the […***…], or the […***…] to a specific Roche Region;

(x)

add additional countries as Core Countries and/or Critical Core Countries; and

(y)

attempt in good faith to resolve any disputes between the Parties.

 

The JOC shall have no responsibility and authority other than that expressly set forth in this Section, in the Related Agreements or as otherwise agreed to in writing by both Parties.

 

4.5

Meetings

The Chairperson or his/her delegate will be responsible for sending invitations and agendas for all JOC meetings to all Members at least […***…] before the next scheduled meeting of the JOC. The venue for the meetings shall be agreed by the JOC. The JOC shall hold meetings at least […***…], either in person or by tele-/video-conference, and in any case as frequently as the Members of the JOC may agree shall be necessary, but not less than […***…]. The Alliance Director of each Party may attend the JOC meetings as a permanent participant.

 

4.6

Minutes

The Chairperson will be responsible for designating a Member to record in reasonable detail and circulate draft minutes of JOC meetings to all members of the JOC for comment and review within […***…] after the relevant meeting. The Members of the JOC shall have […***…] to provide comments. The Party preparing the minutes shall incorporate timely received comments and

 

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distribute finalized minutes to all Members of the JOC within […***…] of the relevant meeting. The Chairperson approves the final version of the minutes before its distribution.

 

4.7

Decisions

4.7.1

Decision Making Authority

The JOC shall decide matters within its responsibilities set forth in Section 4.4.

4.7.2

Consensus; Good Faith

The Members of the JOC shall act in good faith to cooperate with one another and seek agreement with respect to issues to be decided by the JOC. The Parties shall endeavor to make decisions by consensus with each Party having one (1) vote.

4.7.3

Failure to Reach Consensus

If the JOC is unable to decide a matter requiring JOC approval by consensus, then the matter shall be escalated to the […***…]. However :

 

(1)

decisions related to the responsibilities in Sections 4.4(l) […***…], (m) (promotional materials outside of the FMI guidelines), and (t) (Average Delivery Time Metric) shall require agreement by the Parties ;

 

(2)

decisions related to Section 4.4 (o) […***…] shall be referred to the CEO of the Roche Group;

 

(3)

decisions related to Section 4.4(u) (Initial Launch and F1CDx Initial Launch Plan) shall be escalated to the JMC as set forth in the Collaboration Agreement, provided that if the JMC is unable to decide such matter, FMI shall have final decision-making authority; and

 

(4)

decisions related to Section 4.4(v) (changes to F1CDx bait set) shall be subject to FMI’s final decision-making authority.

 

4.8

Information Exchange

FMI and Roche shall exchange the information in relation to its activities under this Agreement through the JOC. FMI and Roche may ask reasonable questions in relation to the above information and offer advice in relation thereto and each Party shall give due consideration to the other Party’s input. The JOC may determine other routes of information exchange. Notwithstanding anything to the contrary in this Agreement, if FMI, FMI’s Affiliates or sublicensees have sales forces in a country/Region outside of the FMI Territory for a product (excluding any sublicensees approved by Roche), then Roche shall have the right to redact competitively sensitive information, including within the Tactical Plans or Post Approval Plans provided to FMI for any Product in such country/Region.   The Tactical Plans and Post Approval Plans for F1CDx in a given country/Region in the Territory may be shared by FMI with any Third Party that is in active negotiations, or has entered into an agreement, with FMI to add a Regulated Claim on F1CDx, provided that any such Third Party agrees to maintain the confidentiality of such Tactical Plans and Post Approval Plans.

 

4.9

Joint Operational Teams

The JOC shall have the right to establish joint operational teams (“ JOT ”), which shall have the authority granted to them by the JOC and shall be comprised of members from both Parties.

 

4.10

Alliance Director

Each Party shall appoint one person to be its point of contact with responsibility for facilitating communication and collaboration between the Parties (each, an “ Alliance Director ”). The

 

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Alliance Directors shall be permanent participants of the JOC meetings (but not M embers of the JOC). The Alliance D irectors shall facilitate resolution of potential and pending issues and potential disputes to enable the JOC to reach consensus and avert escalation of such issues or potential disputes.

 

4.11

Limitations of Authority

The JOC shall have no authority to amend or waive any terms of this Agreement.

 

4.12

Expenses

Each Party shall be responsible for its own expenses including travel and accommodation costs incurred in connection with the JOC.

 

4.13

Lifetime

The JOC shall exist during the Agreement Term.

 

5.

Supply

Subject to Sections 7.3.3 (FMI’s Decision Not to Offer F1CDx in a Country in the Territory) and 7.4.2.3 (NGS Sequencing and Supply of Products and Service Activities), FMI shall be solely and exclusively responsible […***…] for the commercial supply of Products for sale in the Territory by or on behalf of Roche, and FMI shall use Commercially Reasonable Efforts to provide Products and Service Activities in the amounts requested by Roche meeting the Quality Standards and Average Delivery Time Metric.

 

For a given Product, if FMI fails to complete the Service Activities associated with such Product in a manner that meets such Product’s Quality Standards for at least […***…] of the Qualified Samples received from Roche in the Territory in a given Calendar Quarter (a “ Quarterly Quality Standards Failure ”) and such failure exists for […***…], then , prior to the end of such second Calendar Quarter, the JOC shall prepare a plan for improving such performance, which plan will be implemented in the […***…]. The JOC will monitor the implementation and effectiveness of such plan with a goal of achieving and maintaining compliance on a consistent basis for such Quality Standards. If, following the implementation of a plan by the JOC to improve such performance, FMI is unable to improve performance, and there is a Quarterly Quality Standards Failure for […***…] (a “ Material Performance Standards Failure ”), then this shall be considered a material breach of this Agreement by FMI.

 

[…***…]. Roche shall have the right, during normal business hours and upon reasonable advanced notice, to audit any Third Party used by FMI or its Affiliates in the supply of Products and services related to Products to the extent permitted in any existing agreements with such Third Party contractors and in accordance with the terms and conditions of such agreements. Any new agreements entered into by FMI with respect to commercial supply of Products for sale in the Territory by or on behalf of Roche, shall provide Roche with the right to audit such Third Party contractor to review performance against the foregoing metrics, provided that Roche shall not be permitted to access or review any Third Party confidential or proprietary information in connection with any audit pursuant to this Article 5.

 

 

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6.

Regulatory

6.1

Responsibility

6.1.1

Responsibility for Products Other than F1CDx

Subject to Roche’s obligation under Section 7.4.1.4 to satisfy the Product Documentation Requirements, unless otherwise agreed to by the Parties, FMI, […***…], shall be responsible for, in consultation with Roche, and shall use Commercially Reasonable Efforts in the preparation of applications for Regulatory Approvals, as well as all governmental approvals required to market, import, have imported, sell and have sold Products (other than F1CDx, which is addressed in Section 6.1.2) in the Territory. FMI shall be responsible for pursuing and compiling all regulatory filing documentation, and Roche shall reasonably assist FMI in preparing and submitting such regulatory filing documentation and interacting with Regulatory Authorities, for Products (other than F1CDx) in the Territory. FMI or its Affiliates shall use Commercially Reasonable Efforts to prepare, or have prepared for it, all regulatory filings and Regulatory Approvals for all Products (other than F1CDx) that are required to be submitted in each country of the Territory where Roche intends to Commercially Launch such Product or has Commercially Launched such Product. Roche shall reasonably assist FMI in submitting all such regulatory filings and Regulatory Approvals in FMI’s name, unless prohibited by Applicable Law, in which case, to the extent required under Applicable Law, Roche shall file such regulatory filings and Regulatory Approvals in Roche’s name. Each Party shall promptly supply the other Party with a copy of all material communications related to such Product to or from any Regulatory Authority in the Territory, including (i) communications with respect to any visits by any governmental authority or Regulatory Authority to any facilities at which any Product is manufactured or sold in the Territory and (ii) any written or oral inquiries about, any procedures in connection with any Product in the Territory.

6.1.2

Responsibility for F1CDx

FMI shall control (a) all regulatory filings for F1CDx, including all submissions, applications and documents in connection with obtaining a Regulatory Approval, and (b) all regulatory strategy, including (i) determination of the filings, data and documentation to submit to the applicable Regulatory Authorities, (ii) the timing of submitting regulatory filings, including any data and documentation, to the applicable Regulatory Authorities, and (iii) any communications with the applicable Regulatory Authorities in connection with F1CDx.

6.1.2.1

Initial Filing

For the Initial Filing in any Regulated Market in the Territory, FMI shall be responsible for, […***…] providing to Roche and/or its Affiliates (as directed by Roche) the regulatory file that resulted in the Regulatory Approval by the FDA in the US for F1CDx.

 

Roche will pay […***…].   FMI and Roche will share equally […***…].

6.1.2.2

Subsequent Claim Filing

For any Subsequent Claim Filing in any Regulated Market in the Territory, FMI shall be responsible for, at FMI’s sole cost, […***…].

 

 

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Notwithstanding the foregoing, if the Subsequent Claim Filing relates to […***…] , then Roche (or its Affiliate or Sublicensee, as applicable ) will be responsible […***…] as set forth herein based upon contracted terms agreed upon by Roche (or its Affiliate or Sublicensee, as applicable) and FMI for such […***…] .

6.1.2.3

Firewall

In a Regulated Market, Roche agrees to establish, or cause to be established, a firewall to protect Third Party information not in the public domain (the “ Firewall ”).  At a minimum, such Firewall will ensure that:

 

(i)

individuals receiving Third Party confidential or proprietary information, including data, related to the F1CDx regulatory filing from FMI on either (a) an Initial Launch, including a F1CDx Initial Launch Plan or the Initial Filing, or (b) a Subsequent Claim Filing, including any documentation submitted in connection with such Subsequent Claim Filing (such individuals, the “ F1CDx Personnel” ), will be the only persons at Roche (or its Affiliate or Sublicensee, as applicable) to receive such Third Party confidential or proprietary information, including data, related to the F1CDx regulatory filing (“ Third Party F1CDx Regulatory Information ”);

 

 

(ii)

the names and titles of the F1CDx Personnel will be disclosed to FMI and other F1CDx Personnel prior to such persons’ working on any such regulatory filings;

 

 

(iii)

the F1CDx Personnel will be available for meetings, either in person or by tele-/video-conference, to discuss the Third Party F1CDx Regulatory Information and the regulatory strategy in connection with pursuing the Regulatory Approval for F1CDx;

 

 

(iv)

the F1CDx Personnel will only use the Third Party F1CDx Regulatory Information for the F1CDx regulatory filing and will not use or rely upon the Third Party F1CDx Regulatory Information for any other purpose; and

 

 

(v)

the F1CDx Personnel will not disclose any Third Party F1CDx Regulatory Information to persons other than other F1CDx Personnel and the applicable Regulatory Authority in connection with the regulatory filing.  

 

 

 

FMI will identify any Third Party F1CDx Regulatory Information to the F1CDx Personnel (a) at the time such information is provided to the F1CDx Personnel or (b) if FMI inadvertently fails to so identify such information at the time FMI provides such information to the F1CDx Personnel, provided that if FMI subsequently identifies such information as Third Party F1CDx Regulatory Information, then Roche will not be liable under this Section 6.1.2.3 for any failure to comply with its obligations related to such information prior to such subsequent identification by FMI. For clarity, FMI shall by solely liable for any damages caused by its failure to identify any Third Party F1CDx Regulatory Information to the F1CDx Personnel at the time such information is provided to the F1CDx Personnel.

 

Roche agrees to execute, and shall cause any Affiliates or Sublicensees to execute, any additional documentation reasonably requested by FMI to confirm the Firewall has been implemented and maintained in a Regulated Market in the Territory.

 

 

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In the event that any portion of Third Party F1CDx Regulatory Information becomes generally known to the public other than as a result of a breach by the Roche Group or any F1CDx Personnel of the Firewall obligations contained in this Section 6.1.2.3, such Firewall obligations will no longer apply to such portion of the Third Party F1CDX Regulatory I nformation.  For clarity, in such event, the Firewall obligations will continue to apply to the remainder of the Third Party F1CDx Regulatory Information.

 

Roche shall make available (and shall require its Affiliates or Sublicensees to make available) policies, and procedures relating to the Firewall and the use of Third Party F1CDx Regulatory Information (collectively, “ Firewall Policies ”) to FMI during regular business hours in such a manner as to not unnecessarily interfere with Roche’s (or its Affiliate’s or Sublicense’s, as applicable) normal business activities.  FMI or its agents shall have the right to audit such Firewall Policies and relevant records to confirm that the Firewall has been implemented and maintained in accordance with the terms of this Agreement in a given Regulated Market in the Territory. FMI shall use the Firewall Policies only for the purpose of confirming compliance with the Firewall requirements herein, and such Firewall Policies and records shall be considered Roche’s Confidential Information.

 

Without limiting any other rights or remedies available to FMI (including pursuant to Section 14.1), if Roche fails to fulfill its obligations under Section 6.1.2.3(i), (iv) or (v), upon notice from FMI of such failure, Roche will have a […***…] cure period.  If, after such fifteen (15) Business Day cure period, Roche has not cured its failure to fulfill such obligations, FMI may, in its sole discretion, elect to either (a) remove such country from the Territory upon written notice to Roche or (b) convert the licenses under Section 2.1 to non-exclusive (either of clause (a) or (b), a “ Territory Revision Event 1 ”).  Upon a Territory Revision Event 1, Roche shall comply with its obligations under Section 17.3.1 (Termination by FMI for Breach by Roche or by Roche without a Cause, or Expiration of the Agreement Term).

 

6.1.2.4

Regulatory Partner

FMI may elect to designate Roche as its local regulatory partner in a given country in the Territory (“ Regulatory Partner ”) to fulfill any portion of the responsibilities of FMI pursuant to Section 6.1.2 (Responsibility for F1CDx) and, upon such election, Roche shall collaborate with FMI on any regulatory filing (including an Initial Filing, Subsequent Claim Filing, CE marking or any other activity in connection with obtaining Regulatory Approval or any other governmental approvals in a given country in the Territory) and will perform such requested regulatory activities in accordance with an agreed upon timeline (“ Roche Regulatory Support ).  

 

If FMI does not designate Roche as its Regulatory Partner in a given country in the Territory and instead seeks to use a Third Party for such regulatory support services for such country, before engaging such Third Party, FMI shall first offer Roche the right to become its Regulatory Partner for such country on the same terms and conditions (including with respect to the scope of regulatory support services and any fees associated therewith) as were offered by the applicable Third Party.  Roche shall have […***…] during which to provide written notice to FMI accepting such offer (“ Regulatory Partner Notice ”). If Roche does not accept such offer within such […***…] period, FMI shall be permitted to engage any Third Party as its Regulatory Partner for such country on terms and conditions substantially similar to the terms and conditions offered to Roche.  If Roche provides the Regulatory Partner Notice in accordance with the terms of this Agreement, Roche shall be the Regulatory Partner for such country.

 

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If Roche is the Regulatory Partner in accordance with Section 6.1.2 (Responsibility for F1CDx) for a given market in the Territory, Roche shall perform such Roche Regulatory Support in a diligent manner and shall use Commercially Reasonable Efforts to perform such Roche Regulatory Support in accordance with the regulatory strategy and instructions provided by FMI and within the time period specified by FMI.

 

For any Non-Regulated Market, Roche will be responsible for the Roche internal FTE costs for providing the Roche Regulatory Support pursuant to this Section 6.1.2.4, and FMI will be responsible for any FMI internal FTE costs.

 

Any Roche Regulatory Support performed by Roche to file a Subsequent Claim Filing and obtain Regulatory Approval on such Subsequent Claim Filing on behalf of a Third Party pursuant to Section 6.1.2.2 (Subsequent Claim Filing) that is subject to payment by FMI shall be reimbursed by […***…], provided that Roche provides an estimate of the anticipated costs for the Roche Regulatory Support in a given country. The actual costs that FMI shall reimburse Roche shall not exceed such estimate by more than […***…] without FMI’s prior approval, such approval not to be unreasonably withheld.  

 

 

Without limiting any other rights or remedies available to FMI (including pursuant to Section 14.1), if Roche fails to fulfill the Roche Regulatory Support obligations as set forth in this Section 6.1.2.4, including by failing to make a timely filing (or response) in order to obtain Regulatory Approval, and there is a delay in the process for obtaining Regulatory Approval or for the Commercial Launch of the therapeutic product and/or the companion diagnostic claim, upon notice from FMI of such failure, Roche will have a […***…] period to cure its failure and make the relevant filings or response, as applicable.  In the event that Roche fails to make the relevant filing or response, as applicable, within such […***…] period, Roche shall pay FMI the following amounts: (x) in the case of a Critical Core Country, […***…] for such failure or (y) in the case of a Core Country that is not a Critical Core Country, […***…].  If, after an additional […***…] cure period, Roche has not provided the Roche Regulatory Support, FMI may, in its sole discretion, elect to either (a) remove such country from the Territory upon written notice to Roche or (b) convert the licenses under Section 2.1 to non-exclusive (either of clause (a) or (b), a “ Territory Revision Event 2 ”).  Upon a Territory Revision Event 2, Roche shall comply with its obligations under Section 17.3.1 (Termination by FMI for Breach by Roche or by Roche without a Cause, or Expiration of the Agreement Term).

 

6.2

Clinical Trials

The Parties shall discuss at the JOC and consider any clinical research (including, without limitation, any investigator sponsored studies and studies with key opinion leaders) to be conducted for the Products during the Agreement Term that may be necessary or reasonably useful in furtherance of market development and access for Products in the Territory. Except as otherwise agreed to by the Parties or as otherwise set forth in this Agreement , Roche shall have the right to conduct local clinical studies (including investigator sponsored studies and clinical studies with key opinion leaders) where such clinical research is for such local country or Region, provided that Roche shall consult with FMI through the JOC and consider in good faith any comments provided by FMI with respect to such strategy and conduct of such local clinical

 

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studies, […***…] in a given country in the Territory during the Agreement Term. Except as otherwise agreed to by the Parties or as otherwise set forth in this Agreement , with respect to any global clinical studies, FMI shall have the right to conduct , […***…] and shall be responsible for the strategy and conduct of such global clinical studies, provided that FMI shall consult with Roche through the JOC and consider in good faith any comments pro vided by Roche with respect to such strategy and conduct of such g lobal clinical studies. If the Parties do not mutually agree to conduct additional global clinical research for the Territory, FMI shall have the right, but not the obligation, to pursue such global clinical research in its sole discretion and shall be responsible for […***…] .

 

6.3

Reporting Adverse Events

If the development or commercialization or a given Product mandates the mutual reporting of Adverse Events, then the Parties will establish procedures for tracking and informing each other concerning such Adverse Events as required by Applicable Law , and shall maintain such databases and execute such agreements as needed for this purpose.

 

If in the course of the activity covered by this Agreement, FMI employees (i) in FMI’s medical affairs group or pathology group or (ii) who are client services representatives or sales account executives, become aware of a suspected Adverse Events/special situation report (pregnancy, breastfeeding, lack of efficacy, overdose, misuse, abuse, off-label use, medication errors (including intercepted and potential), occupational exposure, suspected transmission of an infectious agent via a medicinal product, death, quality defect or falsified medicinal product) associated the use of a Roche medicinal product, this should be reported to the Roche Drug Safety department at welwyn.pds-pc@roche.com promptly.  As used herein, “ Adverse Event ” means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.  An Adverse Event can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

 

6.4

Reimbursement

Roche will be responsible, […***…] in cooperation with FMI, for all activities related to reimbursement approval for Products in the Territory. Prior to submission, Roche shall discuss its proposed filings for reimbursement approval of Products at the JOC and shall consider in good faith any comments provided by FMI with respect to such filings. After those materials have been submitted to the appropriate pricing authority, Roche shall permit FMI to obtain copies of such materials, including in electronic format, at reasonable times. However, if FMI or its Affiliates or sublicensees (other than any sublicensees that have been approved by Roche) have sales forces in a country/Region outside of the FMI Territory for a FMI clinical diagnostic product, then Roche shall have the right to redact from such filings competitively sensitive information on reimbursement approvals to FMI for any Product in such country/Region. Roche shall use Commercially Reasonable Efforts to file submissions for reimbursement approval in each country where it intends to, or has, Commercially Launched a Product. For clarity, submissions for reimbursement approval in the Territory shall be consistent with the […***…] agreed upon by the Parties.

 

 

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7.

Commercialization

7.1

Strategies

The Parties will implement on the strategies agreed to at the JOC and JMC, in a staged approach and according to detailed Tactical Plans and Post-Approval Plans for each country/Region. Subject to the terms of this Agreement, unless otherwise agreed by the Parties, Roche shall have the exclusive right (even as to FMI) to market, distribute and sell Products in the Territory in accordance with the terms of this Agreement. Notwithstanding this exclusive right, the JOC shall consider utilizing FMI to conduct certain medical educational and/or medical affairs activities in connection with a Tactical Plan.

 

7.2

Sales

Except as otherwise expressly agreed between the Parties:

 

 

(a)

Subject to the Existing Third Party Rights and the Transitional Services Agreement , Roche will book all sales of Products in the Territory.

 

 

(b)

Subject to the Existing Third Party Rights and the Transitional Services Agreement , Roche will be responsible for billing and collections of Products in the Territory.

 

7.3

F1CDx Initial Launch Plan, Subsequent Claim Filings, and Non-Regulated Updates

7.3.1

F1CDx Initial Launch Plan

During the Agreement Term, FoundationOne will be replaced with F1CDx, in each market in the Territory, following notice from FMI that FMI desires to Commercially Launch F1CDx in a given market (“ F1CDx Launch Notice ”). The timeline of implementing the updated F1CDx bait set will be determined by FMI. FMI will be responsible for the preparation of a plan with respect to the timing of the Initial Launch for F1CDx in a given country or region in the Territory (each, an “F1CDx Initial Launch Plan ”), which will be agreed upon by the JOC pursuant to Section 4.4.  

 

Each F1CDx Initial Launch Plan shall include, at a minimum, the following, in each case, as related to the specific country or region in the Territory: (i) the projected timeline of the Initial Launch of F1CDx (either a target date or by reference to the date on which the required approvals have been received), (ii) the date by which the Parties anticipate that the FoundationOne Product will no longer be commercially available in such country and will instead be fully replaced by F1CDx, and (iii) the appropriate size for the Dedicated Sales Force.  The Parties acknowledge and agree that FMI will use the same F1CDx bait set in the Territory that it uses in the US (based on the F1CDx Product approved by the FDA), as the same may be modified over time, with any modifications to the bait set to be reviewed by the JOC pursuant to Section 4.4.  The F1CDx Initial Launch Plan will be in addition to the Tactical Plan and Post Approval Plan for F1CDx in a given country in the Territory.

 

As of the date FMI provides the F1CDx Launch Notice for a given country or region in the Territory: (a) if Roche has not Commercially Launched the FoundationOne Product in such country or region, Roche shall not Commercially Launch the FoundationOne Product and shall instead Commercially Launch F1CDx in such country or region in accordance with the applicable F1CDx Initial Launch Plan, (b) if Roche has Commercially Launched the FoundationOne Product in such country or region, and such country or region is a Regulated Market, Roche shall continue to make the FoundationOne Product commercially available until the necessary Regulatory Approvals have been received to commercialize F1CDx in such country, after which time Roche

 

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shall Commercially Launch F1CDx in accordance with the terms of this Agreement and the applicable F1CDx Initial Launch Plan (and following Commercial Launch of F1CDx in such country, Roche will stop commercializing FoundationOne in such country) , and (c) if Roche has Commercially Launched the FoundationOne Product in such country or region, and such country or region is a Non-Regulated Market, FMI shall incorporate the F1CDx bait set on the timeline outlined by FMI in the F1CDx Initial Launch Plan for such country or region (which shall be subject to FMI’s sole discretion), after which incorporation, Roche shall Commercially Launch F1CDx and stop commercializing FoundationOne in such country. Appendix 7.3.1 lists all of the countries in which Roche has launched FoundationOne as of the Restatement Date .  

 

During the Agreement Term, Roche will use Commercially Reasonable Efforts to Commercially Launch F1CDx (1) in each country in the Territory for which FMI has delivered an F1CDx Launch Notice and (2) in accordance with the timelines set forth in the applicable F1CDx Initial Launch Plan for each Core Country.  Roche shall ensure that F1CDx is Commercially Launched in each country or region in the Territory: (a) by the target date set forth in the F1CDx Initial Launch Plan or (b) in the absence of a launch target date as set forth in the F1CDx Initial Launch Plan, within […***…] following the Parties’ agreement that all required Regulatory Approvals have been received in such market (either of clause (a) or (b), the “ Initial Launch Requirement ”).  

 

In a given country in the Territory, (a) if Roche determines not to commercialize F1CDx in such country, or (b) subject to Section 7.3.2 (Subsequent Claim Filings and Non-Regulated Updates) and 7.4.1.4 (Commercial Launch Obligations), if Roche fails to use Commercially Reasonable Efforts to satisfy its commercialization obligations with respect to F1CDx (including a Subsequent Claim Filing or Non-Regulated Update, as applicable) in such country, FMI may, in its sole discretion, elect to either (i) remove such country from the Territory upon written notice to Roche or (ii) convert the licenses under Section 2.1 to non-exclusive (either of clause (i) or (ii), a “ Territory Revision Event 3 ”).  Upon a Territory Revision Event 3, Roche shall comply with its obligations under Section 17.3.1 (Termination by FMI for Breach by Roche or by Roche without a Cause, or Expiration of the Agreement Term).

 

Without limiting any other rights or remedies available to FMI (including pursuant to Section 14.1), if Roche does not satisfy the Initial Launch Requirement with respect to a given country, FMI shall provide written notice to Roche identifying such non-compliance in the given country, and Roche shall have a period of […***…] after such notice is provided to cure such non-compliance.  If Roche has not cured such non-compliance within such […***…] period, Roche shall pay FMI […***…] for any country that is a Critical Core Country and (ii) […***…] for any Core Country that is not a Critical Core Country.  Following such […***…] cure period, Roche will have an additional […***…] period to ensure compliance with the foregoing requirements in this Section 7.5.1. If Roche has not cured such non-compliance within such additional […***…] period, FMI may, in its sole discretion, elect to either (x) remove such country from the Territory upon written notice to Roche or (y) convert the licenses under Section 2.1 to non-exclusive (either of clause (x) or (y), a “ Territory Revision Event 4 ”).  Upon a Territory Revision Event 4, Roche shall comply with its obligations under Section 17.3.1 (Termination by FMI for Breach by Roche or by Roche without a Cause, or Expiration of the Agreement Term).

 

7.3.2

Subsequent Claim Filings and Non-Regulated Updates

Following the Initial Launch in a Regulated Market, FMI will provide reasonable notice to Roche regarding the anticipated timeline for any Subsequent Claim Filing.  Roche will ensure that any

 

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Subsequent Claim Filing s, and any updates to F1CDx in a Non-Regulated Market ( Non-Regulated Update s ), are Commercially Launched in such market in the time period mutually agreed to by the Parties.  In the absence of a mutually agreed date, Roche will ensure that (a) any updates t o F1CDx that include Subsequent Claim Filing s are Commercially Launched in the applicable market following the Parties’ agreement that all required Regulatory Approvals have been received for such Subsequent Claim Filing within a time period that is consistent with the time period that Roche would apply if the companion diagnostic claim in such Subsequent Claim Filing were for a Roche Group therapeutic (but no longer than […***…] following the issuance of a ll required Regulatory Approval s for such Subsequent Claim Filing ) , and (b) any Non-Regulated Updates are Commercially Launched within a time period that is consistent with the time period that Roche would apply if the companion diagnostic claim in such Non-Regulated Upda te were for a Roche Group therapeutic (but no longer t han […***…] following the proposed addit ion by FMI of the Non-Regulated Update ) .  

 

Without limiting any other rights or remedies available to FMI (including pursuant to Section 14.1), if Roche does not satisfy the timing of the Subsequent Claim Filing or the Non-Regulated Update set forth in this Section 7.3.2 with respect to a given country in the Territory, FMI shall provide written notice to Roche identifying such non-compliance in the given country, and Roche shall have a period of […***…] after such notice is provided to cure such non-compliance.  If Roche has not cured such non-compliance within such […***…] period, Roche shall pay FMI (i) […***…] for any country that is a Critical Core Country and (ii) […***…] for any Core Country that is not a Critical Core Country.  Following such […***…] cure period, Roche will have an additional […***…] period to ensure compliance with the foregoing requirements in this Section 7.3.2 for any country in the Territory.  If Roche has not cured such non-compliance within such additional […***…] period, FMI may, in its sole discretion, elect to either (x) remove such country from the Territory upon written notice to Roche or (y) convert the licenses under Section 2.1 to non-exclusive (either of clause (x) or (y), a “ Territory Revision Event 5 ”).  Upon a Territory Revision Event 5, Roche shall comply with its obligations under Section 17.3.1 (Termination by FMI for Breach by Roche or by Roche without a Cause, or Expiration of the Agreement Term).

7.3.3

FMI’s Decision Not to Offer F1CDx in a Country in the Territory

Notwithstanding anything to the contrary in Section 7.3.1, if the Commercial Launch of  F1CDx in any country in the Territory requires the conduct of any Service Activities for F1CDx in such country (for example, establishing new infrastructure such as a wet and/or dry laboratory) or establishes or maintains requirements that could reasonably be expected to have a material adverse effect on FMI’s business or operations, FMI may, in its sole discretion, decide: (i) not to offer F1CDx in such country in the Territory, or (ii) to otherwise work with Roche on mutually agreeable terms to make F1CDx available in such country.

 

7.4

Additional Responsibilities

7.4.1

Roche Responsibilities

7.4.1.1

Funding Commitment

Subject to FMI meeting its obligations under this Agreement, during the first […***…] of the Initial Term, Roche will commit at least […***…] in Roche FTE resources (based on Roche’s standard FTE rates as consistently applied) and out-of-pocket expenditures for the activities under this Agreement. FMI may audit Roche in accordance with Article 11 to ensure compliance with this Section. Notwithstanding the above, if there is a reduction in the scope of the Territory pursuant to Section 7.2, then FMI and Roche shall negotiate in good faith an adjustment to the […***…] commitment to equitably reflect the reduction in the market value of the Territory.

 

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7.4.1.2

Minimum Revenue Requirement

Commencing in […***…], in connection with the review of the Tactical Plan, […***…] (the “ Minimum Revenue Requirements ”).  If the specifications for a Product are modified pursuant to Section 2.3, the JOC may establish new Minimum Revenue Requirements for such Product for the year in which such modification occurs.  Roche will […***…].  If Roche fails to meet the Minimum Revenue Requirements for a Product in any country in the Territory for […***…], then FMI will have the right, in its sole discretion, to either (i) remove such country from the Territory (and upon such election such country shall be deemed to be included in the FMI Territory) or (ii) convert the license for such country to non-exclusive.

7.4.1.3

Commercial Activities

Throughout the Agreement Term, subject to Sections 4.4(u) (JOC responsibility relating to Initial Launch of F1CDx and F1CDx Initial Launch Plan), 4.4(v) (JOC responsibility regarding changes to F1CDx bait set), 6.1.2 (Responsibility for F1CDx), 7.3.1 (F1CDx Initial Launch Plan), and 7.3.3 (FMI’s Decision Not to Offer F1CDx in a Country in the Territory), Roche will be responsible for the preparation of country-or Region-specific Tactical Plans and Post-Approval Plans for Products in the Territory, which shall be updated […***…] and submitted to the JOC for review and comment. All activities under this Agreement will be conducted in accordance with country- or Region-specific Tactical Plans and Post-Approval Plans to be developed by Roche, working in cooperation with FMI, subject to review and approval by the JMC.

 

Roche will use Commercially Reasonable Efforts to initiate and pursue market development and Commercially Launch (i) Products (other than F1CDx) in the Territory in accordance with the Tactical Plans, Post Approval Plans and the terms of this Agreement and (ii) F1CDx in each country in the Territory in accordance with the F1CDx Initial Launch Plan, Tactical Plan and Post Approval Plan, in each case specific to such country and in accordance with the terms of this Agreement.  

7.4.1.4

Commercial Launch Obligations

Roche will be responsible for Commercially Launching each Product in a given country in the Territory for which FMI has delivered a launch notice, and will ensure such Product remains Commercially Launched in such country in the Territory. To satisfy such obligations, Roche will be responsible for:

 

(a)

maintaining (i) a dedicated MSL to support, and (ii) a Dedicated Sales Force to promote, such Product in such country or region, as applicable (for clarity, an MSL or Dedicated Sales Force may serve a country or group of countries, i.e. a region, in the case of countries with smaller markets; provided, however, that each Critical Core Country shall have its own Dedicated Sales Force dedicated solely to promoting the Products);

 

 

(b)

in each country or region, as applicable, that has launched a Product, including any country listed on Appendix 7.3.1 (with respect to FoundationOne) and any country or region, as applicable, that Commercially Launches a Product after the Restatement Date, maintaining (i) an MSL to support, and (ii) a Dedicated Sales Force to promote, such Product in such country or region, as applicable; provided, however, that each Critical Core Country shall have its own Dedicated Sales Force dedicated solely to promoting the Products;

 

 

(c)

providing marketing messaging (including Product marketing materials,

 

 

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collateral and Product communications by any MSL or Dedicated Sales Force) with respect to each Product in such country or region, as applicable, in a manner that is consistent with FMI’s messaging relating to such Product in the US ( e.g. , for F1CDx, mentioning that F1CDx may be used as a companion diagnostic for multiple therapies);

 

 

(d)

specific to F1CDx, ensuring that, in such country or region (subject to clauses (a) and (b) above in this Section 7.4.1.4), as applicable: (i) the Dedicated Sales Force is fairly presenting all companies’ (including Third Parties’ and Roche’s and its Affiliates’) therapies and claims on F1CDx in the process of promoting F1CDx, without any bias and without favoring any of Roche’s or its Affiliates’ therapies or claims and (ii) any MSL is fairly presenting all companies’ (including Third Parties’ and Roche’s and its Affiliates’) therapies and claims on F1CDx in its communications related to the Products, without any bias and without favoring any of Roche’s or its Affiliates’ therapies or claims;

 

 

(e)

ensuring that all Product documentation, including documents necessary to order a Product in such country ( e.g. , patient consents, order forms, and patient information), is obtained and maintained in compliance with Applicable Laws (“ Product Documentation Requirements ”); and

 

 

(f)

providing sufficient customer service support for such Product to support such Product’s customers in such country or region, as applicable.

 

 

Roche shall satisfy the ongoing obligations required for the Commercial Launch of each Product (as set forth in this Section 7.4.1.4).  Without limiting any other rights or remedies available to FMI (including pursuant to Section 14.1), if, during the Agreement Term, following the Commercial Launch of a Product, Roche no longer satisfies any of its ongoing obligations for the Commercial Launch of such Product (as set forth in this Section 7.4.1.4) with respect to a given Product in a given country, FMI shall provide written notice to Roche identifying such non-compliance in the given country, and Roche shall have a period of […***…] after such notice is provided to cure such non-compliance.  If Roche has not been cured such non-compliance within such […***…] period, FMI may, in its sole discretion, elect to either (x) remove such country from the Territory upon written notice to Roche or (y) convert the licenses under Section 2.1 to non-exclusive (either of clause (x) or (y), a “ Territory Revision Event 6 ”).  Upon a Territory Revision Event 6, Roche shall comply with its obligations under Section 17.3.1 (Termination by FMI for Breach by Roche or by Roche without a Cause, or Expiration of the Agreement Term).

 

 

7.4.1.5

Equitable Adjustments

Where either Roche or FMI has an obligation under this Agreement (each such a “ Dependent Obligation ”) that can only reasonably be fulfilled if the other Party first performs one or more of its specific contractual obligations hereunder (each , a “ Precedent Obligation ”), then, any deadline for the performance by Roche or FMI, as applicable, of such Dependent Obligation shall be tolled (i.e., the deadline shall be extended) for a period of time equal to the delay in the performance by such other Party of the relevant Precedent Obligation. For avoidance of doubt, each such deadline shall be similarly tolled to the extent achievement of an obligation under this Agreement is prevented by an event of force majeure as and to the extent provided in Section 19.16.

 

 

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7.4.1.6

Customer Service

During the Agreement Term, Roche shall implement, in each country in the Territory and consistent with the Tactical Plans (including in which local country languages and in which manner such customer service shall be provided) and the F1CDx Initial Launch Plan, if applicable, reasonable levels of customer service assistance to support Product customers in such country regarding sales and technical support issues, customer inquiries, defective product and service replacements. Roche shall be responsible for all costs and expenses associated with the provision of such customer service. Upon FMI’s request, but no more than once per Calendar Year, Roche shall provide FMI with a report summarizing customer service assistance requests and inquiries received by Roche . Upon Roche’s request, but no more than once per Calendar Year, FMI shall provide Roche with a report summarizing customer service assistance requests and inquiries received by FMI in the Territory.

 

Without limiting any other rights or remedies available to FMI (including pursuant to Section 14.1), if Roche does not comply with any of its obligations set forth in this Section 7.4.1.6 with respect to a given country, FMI shall provide written notice to Roche identifying such non-compliance in the given country, and Roche shall have a period of […***…] after such notice is provided to cure such non-compliance.  If Roche has not cured such non-compliance within such […***…] period, FMI may, in its sole discretion, elect either to (i) remove such country from the Territory upon written notice to Roche or (ii) convert the licenses under Section 2.1 to non-exclusive (either of clause (i) or (ii), a “ Territory Revision Event 7 ”).  Upon a Territory Revision Event 7, Roche shall comply with its obligations under Section 17.3.1 (Termination by FMI for Breach by Roche or by Roche without a Cause, or Expiration of the Agreement Term).

7.4.2

FMI Responsibilities

7.4.2.1

Product Training

FMI will provide Roche with NGS and Product training using Commercially Reasonable Efforts, including samples of each related training material used by FMI in the FMI Territory throughout the Agreement Term. Such training will be provided in the locations and on the schedule agreed to in the Tactical Plans. Each Party shall be responsible for their respective costs in relation thereto. For clarity, FMI trainers will provide this training at no charge to Roche.

7.4.2.2

Materials

[…***…], or more frequently when available throughout the Agreement Term, FMI will provide Roche with copies of its then current Product marketing material, and will share with Roche any Product brand, promotional, or similar plans, any market research plans and results, any educational materials or other information or analysis prepared by or for FMI related to the Products in the FMI Territory or in the Territory.

7.4.2.3

NGS Sequencing and Supply of Products and Service Activities

Subject to Section 7.3.3 (FMI’s Decision Not to Offer F1CDx in a Country in the Territory), FMI shall use Commercially Reasonable Efforts to provide Roche with the Service Activities (including next generation sequencing (“ NGS ”)) necessary for Roche to implement the Tactical Plan and to meet the commercial need for Products sold by Roche in the Territory. Such Service Activities will meet the Quality Standards and the Average Delivery Time Metric.  In the event of a shortfall/limited capacity of Products or Service Activities needed by both FMI and Roche, such available capacity shall be distributed […***…] with respect to the then-current volume used by each Party.

 

 

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For each Product, FMI will provide the JOC with the average time between receipt by FMI of a processable sample meeting minimum tissue or other specimen requirements as set forth in FMI’s standard operating procedures (such sample, a “ Qualified Sample ”) and delivery by FMI of the results of testing for such Product (the “ Average Delivery Time Metric ”).  Such Average Delivery Time Metric will initially be […***…] for FoundationOne ® and F1CDx, and […***…] days for FoundationOne ® Heme and FoundationACT®, in each case, solely to the extent Service Activities for such Product are conducted by FMI at FMI’s laboratory and facilities in the US. P eriodically, the Average Delivery Time Metric may be revised by mutual written agreement of the Parties for differences in logistical, regulatory and other relevant factors.  For a given Product, if FMI fails to achieve the Avera ge Delivery Time Metric for at least […***…] of the Qualified Samples received from Roche in the Territory in […***…] Calendar Quarter (a “ Quarterly Average Delivery Time Failure ”) and such failure exists […***…] , then prior to the end of such […***…] , the JOC shall prepare a plan for improving such performance , which plan will be implemented in the […***…] .  T he JOC will monitor the implementation and effectiveness of such plan with a goal of achieving and maintaining compliance on a consistent basis for such Average Delivery Time Metric. If, following the implementation of a plan by the JOC to improve such performance, FMI is unable to improve performance, and there is a Quarterly Average Delivery Time Failure for an additional […***…] (a “ Material Average Delivery Time Failure ”), then this shall be considered a material breach of this Agreement by FMI.

 

To the extent feasible and permitted by Applicable Law and regulatory guidelines of applicable Regulatory Authorities, the initial sequencing will be conducted by FMI at FMI’s laboratory and facilities in the US.

 

FMI shall use Commercially Reasonable Efforts to conduct or have conducted genomic sequencing locally (i) for its FoundationOne Product […***…] and (ii) for its other First Year Products […***…].  FMI shall provide Roche with a written plan for the set-up of such […***…] laboratories, and shall consider Roche’s reasonable comments thereto.  FMI shall update Roche on the progress of the establishment of local testing.  Such […***…] activities shall be provided in at least the same quality and standards as the […***…] testing in effect as of the Effective Date. To the extent that local Third Party costs are passed through to Roche, such costs shall be negotiated in good faith and at arms’ length with no benefits being given to FMI to the advantage or FMI, its Affiliates, sublicensees or customers that cause a disadvantage or do not similarly benefit the Roche Group and its customers.

 

FMI will be solely responsible, […***…], for the establishment of such laboratories and all Regulatory Approvals necessary for the establishment and operation of such laboratory(ies). Without limiting the foregoing, the Parties expressly acknowledge that FMI may choose to work with […***…] .

 

Unless otherwise expressly agreed by the Parties, data and final analysis, including medical curation and report generation will be conducted by FMI.  Final reports for the First Year Products will be provided from FMI in English or in the local language, to the extent requested by Roche and agreed to by FMI.  If FMI is unable to provide local sequencing on the timeline set forth in this Section 7.4.2.3, or if FMI is unable to provide the NGS sequencing necessary to meet Roche’s commercial requirements for a period of […***…], then the JOC shall meet to determine a plan for improving such performance and the JOC will monitor the implementation and effectiveness of such plan, and FMI will provide reasonable support, with a goal of ensuring ongoing access to sufficient local sequencing, which may include Roche (itself or with or through a Third Party acceptable to FMI) performing such local sequencing in a manner approved by FMI that meets FMI’s requirements for performing subsequent Service Activities.

 

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7.5

Branding and Pricing

Product branding and corporate-level branding will be discussed and agreed to at the JOC. The Parties will discuss at the JOC a […***…] in the Territory (the “[…***…]”). Unless otherwise expressly agreed by the Parties, the list price for each Product in the Territory will be equal to or greater than the […***…] for such Product.

 

7.6

Product Promotional Materials and Promotional Obligations

The Parties will collaborate and coordinate around development of any promotional or educational materials to be utilized for Products in the Territory leveraging FMI’s existing materials.

 

Roche shall be responsible for the preparation of all product promotional material for use with the Products by Roche in the Territory. All such Product promotional material shall be consistent with reasonable brand and Product guidelines provided to Roche by FMI. Any Product promotional materials not consistent with such approved guidelines shall be subject to review and approval by FMI. Notwithstanding the foregoing, any Product promotional guidelines and materials approved by FMI to be used by Roche will be subject to final review and approval by Roche.

 

To the extent permitted by Applicable Law, Roche’s sales and commercial representatives who promote Roche therapeutics shall be permitted to promote F1CDx, provided , for the avoidance of doubt, that this shall not relieve Roche of its obligation to maintain a Dedicated Sales Force as provided herein.

 

7.7

F1CDx Report

The content of the F1CDx report generated for any customers, whether in paper or electronic format (the “ F1CDx Report ”), shall contain the following:

 

(a)

in a Regulated Market: (i) a section reviewed and approved by the applicable Regulatory Authority, including any companion diagnostic claims and associated approved therapies (the “ Regulated Claims ”); and (ii) a section describing professional services, including variants, associated therapies, and clinical trials, based on the professional services section used in the United States (the “Professional Services ”).  For clarity, the F1CDx Report in a Regulated Market will be developed based on the requirements of the applicable Regulatory Authority.  

 

(b)

in a Non-Regulated Market: the Professional Services section only.  For clarity, the F1CDx Report in a Non-Regulated Market shall not include a Regulated Claims section.

 

If (i) required by the applicable Regulatory Authority for a country in which Roche Commercially Launches F1CDx or (ii) FMI otherwise elects to, FMI will generate an F1CDx Report that only includes Regulated Claims as approved in such country, subject to Roche providing localized content on approved companion diagnostics and approved therapies in the English language as set forth below.  All of FMI’s expenses and internal FTE costs (based on the then-current FTE Rate pursuant to the Collaboration Agreement) to develop, implement and maintain the Regulated Claims section of the F1CDx Report with localized reporting in a given country in the Territory will be borne […***…] by Roche and […***…] by FMI, as such country is a Regulated Market.

 

 

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If (a) requested by Roche and approved by FMI or (b) FMI otherwise elects to , FMI will localize, in accordance with the “in scope” localization provisions set forth on Appendix 7.7 , the Professional Services section, and if applicable ( according to the preceding paragraph in this Section 7.7 ) , the Regulated Claims section, of the F1CDx Report to generate a report with localized content including approved therapies.  In such event, Roche will, at its cost, provide localized content in the English language, and FMI will implement the localized reporting of the Professional Services section, and if applicable ( according to the preceding paragraph in this Section 7.7 ) , the Regulated Claims section.  All of FMI’s expenses and internal FTE costs (based on the then-current FTE Rate pursuant to the Collaboration Agreement) to develop, implement and maintain such localized reporting in a given country in the Territory (i) will be shared equally be FMI and Roche if such country is a Non-Regulated Market and (ii) will be borne […***…] by Roche and […***…] by FMI if such country is a Regulated Market. If the applicable Regulatory Authority in a Regulated Market requires a localized Professional Services section, and such requirement will have a material adverse impact on Roche (other than on account of competitive products being developed or becoming available in a given market), then FMI and Roche shall discuss in good faith an alternative plan.

 

If neither Roche nor FMI elects to localize the F1CDx Report content on approved therapies in a given country, FMI will provide to Roche a copy of the then-current US version of the F1CDx Report template.

 

Roche shall be solely responsible for providing FMI with any F1CDx Report localized content on approved companion diagnostics and approved therapies in the English language.   Subject to Applicable Law, Roche, in its sole discretion, may perform translation of parts of, or the whole, F1CDx Report into local languages, and Roche will be required to perform such translation into local languages to the extent required by Applicable Law or a Regulatory Authority. Roche will be responsible and liable for (i) ensuring the accuracy and completeness of any localized content provided in English to FMI and any translation of the F1CDx Report into the local language, and (ii) all cost associated with providing such content and translation.  If Roche, in its sole discretion, elects to, or is required to, provide a translation (into the local language) of the F1CDx Report to customers, Roche must also provide a copy of the version in the English language to the customers, unless the same would be prohibited by Applicable Law.

 

8.

Payment

8.1

General

Except as otherwise expressly provided for in this Agreement, each Party shall bear its own costs, expenses, and fees for its activities under this Agreement, including without limitation, costs incurred in connection with the Tactical Plans.   For clarity, all costs, expenses, and fees (including any costs incurred with Third Parties and any internal FTE costs), relating to F1CDx incurred prior to the Restatement Date shall be borne by the Party that incurred such costs, expenses, and fees.

 

8.2

Costs of Services

8.2.1

FMI Service Costs

For each Product sold in the Territory, if FMI provides Service Activities for such Product at FMI’s laboratories and facilities in the United States, Roche will pay FMI […***…] (collectively the “ Global Cost ”) […***…] (collectively, the “ Global Test Fixed Fee ”). The Global Test Fixed Fee for a Product will be calculated on a trailing […***…] basis, and the Global Test Fixed Fee and calculation shall be provided to Roche within […***…] after each […***…] in the Agreement Term, based on the Global Test Fixed Fee as determined from the preceding […***…] and […***…] during the Agreement Term, subject to audit by Roche in accordance with Article 11.

 

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For each Product sold in the Territory , if FMI provides initial sequencing in laboratories and facilities outside of the US, Roche will pay FMI […***…] (collectively, the “ Local Cost ”), […***…], and (ii) […***…] (collectively, the “ US Cost ”), […***…] (clause (i) and clause (ii), collectively, the “ Local Test Fixed Fee ”). The Local Test Fixed Fee for a Product will be calculated on a trailing […***…] basis, and the Local Test Fixed Fee and calculation shall be provided to Roche within fifteen (15) days after each […***…] in the Agreement Term, based on the Local Test Fixed Fee as determined from the preceding […***…] and […***…] during the Agreement Term, subject to audit by Roche in accordance with Article 11.

 

FMI will submit invoices on a […***…] basis , and Roche shall pay all Global Test Fixed Fees and Local Test Fixed Fees within […***…] following Roche’s receipt of an invoice for such fees.

8.2.2

Third Party Service Costs

FMI may have all or part of the Service Activities for Products in the Territory performed by a Third Party, subject to the terms and conditions for Third Parties set forth in Section 7.4.2.3 (NGS Sequencing and Supply of Products and Service Activities) or as otherwise agreed to in writing by Roche. In the event that all or part of the Service Activities are performed by a Third Party, Roche shall reimburse FMI for the amount paid by FMI to such Third Party for such Service Activities (the “ Third Party Test Fee ”), provided that (i) such Third Party Test Fees are negotiated in good faith and at arms’ length with no benefits being given to FMI to the advantage or FMI, its Affiliates, sublicensees or customers that cause a disadvantage or do not similarly benefit the Roche Group and its customers and (ii) […***…].

 

Roche shall pay all Third Party Test Fees within […***…] following Roche’s receipt of an invoice for such fees.

 

8.3

Royalty Payments and Sales Milestones

8.3.1

Royalty Term

Royalties shall be payable by Roche on […***…] of Products on an aggregated basis for all Products commencing on the first commercial sale of a Product and continuing for so long as Roche is selling any Product (“ Royalty Term ”).

8.3.2

Royalty Rates

The following royalty rates shall apply to the respective tiers of aggregate […***…] of Products in the Territory, on an incremental basis, as follows:

 

 

[…***…]

[…***…]

[…***…]

[…***…]

[…***…]

[…***…]

[…***…]

[…***…]

[…***…]

[…***…]

 

For example, if […***…] of Products in the Territory on an aggregated basis, for the first […***…] in a given […***…], is […***…]:

 

 

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[…***…]

 

If then in the […***…] of such […***…], the […***…] of     Products […***…] is […***…] for such […***…] thus far[…***…]:

 

[…***…]

 

For the purpose of calculating royalties of a Product, […***…] and the royalty rates shall be subject to the following adjustments, as applicable.

8.3.2.1

Virtual […***…]

If the Sales of a given Product anywhere in the Territory (excluding any countries in the Territory as otherwise mutually agreed to by the Parties) is below […***…] per unit for such Product, then the Gross Margin for such units of Product shall be calculated by Roche Region (as described below) […***…] (the “ Virtual Gross Margin Calculation ”).

 

For purposes of determining the Virtual Gross Margin Calculation, the aggregate Sales of each Product in the Territory (excluding any countries in the Territory as otherwise mutually agreed to by the Parties) on a Calendar Quarter basis shall be calculated on a regional basis as the greater of: […***…].  The Virtual Gross Margin Calculation shall be calculated on a Roche Region by Roche Region basis.

8.3.3

Third Party Payments

In the event that it is necessary for Roche to obtain a license from a Third Party for Third Party intellectual property rights to use or sell the Product in the Territory following the Effective Date, Roche shall have the right to deduct […***…] of any consideration actually paid to such Third Party for such license from the royalties otherwise due and payable by Roche to FMI under this Section 8.3; provided, however, that in no case shall such reduction lower the amount of royalties otherwise payable under this Section 8.3 by more than […***…].

8.3.4

Sales Milestones

Roche will pay a one-time, non-refundable, non-creditable sales milestone payment of […***…] to FMI the first time the aggregate annual Gross Margin of […***…] in a given Calendar Year first reach […***…]. […***…].

8.3.5

Collaboration Products

The financial terms for each Product , […***…] that is a Collaboration Product (including royalty rates and sales milestone payments ), and the diligence obligations for any such Product (including Commercial Launch obligations and Minimum Revenue Requirements) must be mutually agreed to in writing by the Parties, taking into consideration the relative contributions made by each Party to the development of such Product, before such Product is included in this Agreement. Following FMI’s decision to Commercially Launch a Collaboration Product (other than FACT or F1CDx) in any country in the Territory, FMI shall provide written notice to Roche, and if the Parties cannot agree to terms and conditions for the inclusion of such Collaboration Product as a Product in this Agreement within […***…] (the “ Initial Discussion Period ”), then the Parties shall each select an independent Third Party expert who is neutral, disinterested and impartial, and has significant relevant experience in the development and commercialization of pharmaceutical products (the “ Expert ”). Each Expert will within […***…] select a […***…] Expert

 

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to form a panel of […***… ] Experts (“ Panel ”). The date on which such Panel is in place will be the “ Arbitration Commencement Date .” Each Party shall , within […***… ] following the Arbitration Commencement Date , prepare and deliver to both the Panel and the other Party its proposed financial terms (including royalty rates and sales milestone payments) and diligence obligations (including initial launch and minimum revenue requirements) (collectively, the “ Arbitration Offer ”) to resolve the disputed matter for such Product and a memorandum (the “ Supporting Memorandum ”) in support thereof ; provided that such Arbitration Offer shall be on the same or substantially similar terms as the last offer made by such Party to the other Party during the Initial Discussion Period. The Panel will also be provided with a copy of this Agreement. Within […***… ] after receipt of the other Party’s Supporting Memorandum, each Party may submit to the Panel (with a copy to the other Party) a rebuttal to the other Party’s Supporting Memorandum (a “ Rebuttal ”), which may include a revision, marked to show changes, of either Party’s proposed terms. Neither Party may have communications (either written or oral) with the Panel other than for the sole purpose of engaging the Panel or as expressly permitted in this Section 8.3.5. Within […***… ] after the Panel’s receipt of each Party’s Rebuttal (or the expiration of the period for the Parties to submit a Rebuttal, if earlier), the Panel will select, between the proposals provided by the Parties, the proposal that the Panel believes most accurately reflects an equitable result for FMI and Roche (the “ Selected Agreement ”). The Panel shall not have the authority to modify a proposal initially submitted by a Party. The decision of the Panel shall be the sole, exclusive and binding remedy and the Selected Agreement shall become a binding and enforceable agreement between the Parties. The Panel will have reasonable discretion to request additional information, hold a hearing, and extend the time frame for reaching a decision regarding the dispute at issue. The Experts’ fees and expenses will be paid by the Party whose proposal is not selected by the Panel. Each Party will bear and pay its own expenses incurred in connection with any proceedings under this Section 8.3.5.

8.3.6

Penalty Payments

Roche shall pay fees due to FMI pursuant to Sections 6.1.2.4 (Regulatory Partner), 7.3.1 (F1CDx Initial Launch Plan), and 7.3.2 (Subsequent Claim Filings and Non-Regulated Updates) (each, a “ Penalty Payment ”), if any, within […***…] following Roche’s receipt of an invoice therefor.

8.3.7

Other Payments

FMI shall provide Roche with monthly invoices for any amounts that Roche owes FMI pursuant to Section 7.7 (F1CDx Report), together with supporting documentation outlining FMI’s costs and fees incurred in connection therewith, and Roche shall pay FMI such amounts within […***…] following Roche’s receipt of an invoice for such amounts.

 

Roche shall provide FMI with monthly invoices for Roche Regulatory Support for each country in which Roche is the Regulatory Partner, together with supporting documentation outlining the Roche actual FTE rate, and FMI shall pay Roche such amounts within […***…] following FMI’s receipt of an invoice for such amounts.

 

Each Party shall provide the other Party with monthly invoices for payments owed pursuant to Section 6.1.2.1, together with supporting documentation outlining the full amount that such Party incurred in accordance with Section 6.1.2.1 in making the Initial Filing in any Regulated Market.  Each Party shall pay the invoiced amounts within […***…] following its receipt of each invoice.

 

 

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8.4

Disclosure of Payments

Each Party acknowledges that the other Party may be obligated to disclose this financial arrangement, including all fees, payments and transfers of value, as may be advisable or required under Applicable Law.

 

9.

Accounting and Reporting

9.1

Timing of Payments

Roche shall calculate royalties […***…] (each being the last day of an Accounting Period ”) and shall pay royalties on Net Sales within the […***…] after the end of each Accounting Period in which such Net Sales occur.

 

9.2

Late Payment

Any payment under this Agreement that is not paid on or before the date such payment is due shall bear interest, to the extent permitted by Applicable Law, at […***…] points above the average one-month Euro Interbank Offered Rate (EURIBOR), as reported by Reuters from time to time, calculated on the number of days such payment is overdue.

 

9.3

Method of Payment

Royalties on Net Sales and all other amounts payable by Roche hereunder shall be paid by Roche in US Dollars (the “ Payment Currency ”) to account(s) designated by FMI.

 

9.4

Currency Conversion

When calculating the Sales of any royalty-bearing Product that occur in currencies other than the Payment Currency, Roche shall convert the amount of such sales into […***…] and then into the Payment Currency using […***…].

 

9.5

Reporting

With each payment, Roche shall provide FMI in writing for the relevant […***…] on an aggregated basis for all Products, and thereafter on a Product-by-Product basis, the following information:

 

[…***…]

[…***…]

[…***…]

[…***…]

[…***…]

[…***…]

[…***…]

[…***…]

 

10.

Taxes

FMI shall pay all sales, turnover, income, revenue, value added, and other taxes levied on account of any payments accruing or made to FMI under this Agreement.

 

If provision is made in law or regulation of any country for withholding of taxes of any type, levies or other charges with respect to any royalty or other amounts payable under this Agreement to FMI, then Roche shall promptly pay such tax, levy or charge for and on behalf of FMI to the proper governmental authority, and shall promptly furnish FMI with receipt of payment. Roche shall be entitled to deduct any such tax, levy or charge actually paid from royalty or other payment due FMI or be promptly reimbursed by FMI if no further payments are due to FMI. Each Party agrees to

 

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reasonably assist the other Party in claiming exemption from such deductions or withholdings u nder double taxation or similar agreement or treaty from time to time in force and in minimizing the amount required to be so withheld or deducted.

 

11.

Auditing

11.1

Right to Audit

In addition to the audit rights set forth in Article 5 (Supply) and Section 6.1.2.3 (Firewall), each Party shall keep, and shall require its Affiliates and sublicensees/Sublicensees to keep, full, true and accurate books of account containing all particulars that may be necessary for the purpose of calculating all amounts payable under this Agreement, such as with respect to royalties in the case of Roche and Cost of Services in the case of FMI. Such books of accounts shall be kept at their principal place of business. At the expense of the auditing Party, the auditing Party shall have the right to engage an independent public accountant from a major, internationally recognized accounting firm, to perform, on behalf of the auditing Party an audit of such books and records of the audited Party and its Affiliates, its licensees and sublicensees/Sublicensees, that are deemed necessary by the auditing Party’s independent public accountant for the period or periods requested by auditing Party and the correctness of any financial report or payments made under this Agreement.

 

Upon timely request and at least […***…] prior written notice from the auditing Party, such audit shall be conducted in the countries specifically requested by the auditing Party, during regular business hours in such a manner as to not unnecessarily interfere with the audited Party’s normal business activities, and shall be limited to results in the […***…] prior to audit notification.

 

Such audit shall not be performed more frequently than […***…] nor more frequently than once with respect to records covering any specific period of time.

 

All information, data documents and abstracts herein referred to shall be used only for the purpose of verifying statements, shall be treated as the audited Party’s Confidential Information subject to the obligations of this Agreement and need neither be retained more than […***…] after completion of an audit hereof, if an audit has been requested; nor more than […***…] from the end of the Calendar Year to which each shall pertain; nor more than […***…] after the date of termination of this Agreement.

 

11.2

Audit Reports

The auditors shall only state factual findings in the audit reports and shall not interpret the Agreement. The auditors shall share all draft audit reports with the audited Party before the draft report is shared with the auditing Party and before the final document is issued.  The final audit report, if any, shall be shared with the audited Party at the same time it is shared with the auditing Party.

 

11.3

Over-or Underpayment

If the audit reveals an overpayment, such overpayment shall be credited against future payments owed by Roche for the amount of the overpayment or, if no further payments are owed by Roche, then FMI shall reimburse Roche for the amount of the overpayment within […***…]. If the audit reveals an underpayment, Roche shall make up such underpayment with the next payment or, if no further payments are owed by Roche, Roche shall reimburse FMI for the amount of the underpayment within […***…]. The audited Party shall pay for the audit costs if the underpayment/over receipt of the audited Party exceeds […***…] of the aggregate amount of

 

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payments owed with regard to the statements subject of the audit. Section 9.2 shall apply to this Section 11.3 .

 

11.4

Duration of Audit Rights

The failure of FMI to request verification of any royalty calculation within the period during which corresponding records must be maintained under this Article 11 will be deemed to be acceptance of the royalty payments and reports.

 

12.

Intellectual Property

12.1

Ownership of Inventions

Ownership of Inventions shall be as set forth in the Collaboration Agreement.

 

12.2

Trademarks and Labeling

The Parties shall attempt to use a uniform global trademark and logo for the Product; provided, that each Party may use its own trademarks and housemarks as it selects to promote the sale of the Product in the FMI Territory, with respect to FMI, and the Territory, with respect to Roche (collectively, excluding the housemarks, the “ Product Trademarks ”). The Parties shall agree on at least […***…] Product Trademarks for each Product, with […***…] of the trademarks being the global trademark and the other(s) being trademarks to be held in reserve in case the global trademark cannot be used in […***…] or more countries. The placement and size of a Party’s housemarks relative to Product Trademarks shall be approved by the JOC. Excluding the Roche housemarks, FMI shall own any global Product Trademarks used on or in connection with Products in the Territory, and shall, at its sole cost, be responsible for procurement, maintenance, enforcement and defense of such global Product Trademarks.

 

Roche shall own its trademarks, including the Roche trademark and hexagon, and may use the Roche trademarks in connection with the Product as set forth in this Section. FMI shall not file any identical registrations or other filings in respect of any such housemarks owned by Roche. FMI shall own its housemark and any trademark it selects to promote the sale of the Product in the FMI Territory. Roche shall not file any identical registrations or other filings in respect of any such trademarks and housemarks owned by FMI.

 

Each Party shall maintain all registrations of such Product Trademarks owned by it , and the other Party shall not file any registrations or other filings in respect of any of such Product Trademark owned by the Product Trademark owning Party without the Product Trademark owning Party’s prior written consent. FMI shall use Commercially Reasonable Efforts to obtain and maintain Product Trademarks, and the Parties will reasonably cooperate with one another to take reasonable measures to enforce oppositions and litigations in relation to the Product Trademarks.

 

Each Party shall use the Product Trademarks in accordance with sound trademark and trade name usage principles and in accordance with all Applicable Law as reasonably necessary to maintain the validity and enforceability of the Product Trademarks. Each Party recognizes that the trademarks owned by the other Party represents a valuable asset of such other Party, and that substantial recognition and goodwill are associated with such name, logo , and trademarks. Each Party hereby agrees that, without prior written authorization of the other Party or as specifically permitted in this Agreement, it shall not use such other Party’s trademarks for any purpose.

 

 

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Each Party shall have the right to police its own trademarks and enforce its own trademarks. Each Party shall have the right to audit the other Party, its Affiliates, sublicensees/Sublicensees and contractors to ensure the quality of the Products to which the trademark is associated.

 

In the event either Party becomes aware of any infringement of any Product Trademark by a Third Party, such Party shall promptly notify the other Party and the Parties shall consult with each other and jointly determine the best way to prevent such infringement.

 

12.3

Prosecution of Patent Rights

Patent Rights shall be prosecuted as set forth in the Collaboration Agreement.

 

12.4

Patent Coordination Team

The JPT as defined in the Collaboration Agreement will address all issues related to Patent Rights.

 

12.5

Infringement

Infringement shall be addressed as set forth in the Collaboration Agreement. However, if Roche is commercializing a Product in a particular country in the Territory, then Roche shall have the first right to enforce Patent Rights in such country in the Territory.

 

12.6

Defense

If an action for infringement is commenced against either Party, its licensees or its sublicensees/Sublicensees, the provisions of the Collaboration Agreement shall apply.

 

12.7

Common Interest Disclosures

With regard to any information or opinions disclosed pursuant to this Agreement by one Party to each other regarding intellectual property and/or technology owned by Third Parties, the Parties agree that they have a common legal interest in determining whether, and to what extent, Third Party intellectual property rights may affect the conduct of the activities under this Agreement. Accordingly, the provisions of the Collaboration Agreement shall apply in this regard.

 

 

13.

Representations and Warranties

13.1

FMI Representations and Warranties

13.1.1

Safety Data

FMI warrants and represents that it has, and covenants that it will, continue to disclose to Roche as soon as possible during the Agreement Term (i) the results of all preclinical testing and human clinical testing Controlled by FMI relating to any Product and (ii) all information in its Control concerning side effects, injury, toxicity or sensitivity reaction and incidents or severity thereof with respect to any Product.

13.1.2

Third Party Patent Rights

FMI warrants and represents that, as of the Effective Date, it has no knowledge of the existence of any patent or patent application owned by or licensed to any Third Party that could prevent Roche from making, having made, using, offering for sale, selling or importing Product in the Territory.

 

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13.1.3

Ownership of Patent Rights

As of the Effective Date and the Restatement Date, FMI warrants and represents that it is the exclusive owner of all right, title and interest in, or is the exclusive licensee of, the FMI Patent Rights in the Territory relating to the use, sale, offer for sale, import, or export of the Products in the Territory.

13.1.4

Ownership of Trademarks

Subject to the licenses granted to Roche pursuant to Sections 2.1.1 and 2.1.3, FMI warrants and represents that it is the exclusive owner of all right, title and interest in, or is the exclusive licensee of the trademarks for the Products in the Territory.

13.1.5

Inventors

FMI warrants and represents that for the inventors of the Inventions disclosed and/or claimed in the disclosed FMI Patent Rights, FMI has obtained the assignment of, or a license under, all interest and all rights or licenses thereunder with respect to the FMI Patent Rights necessary to grant the licenses granted hereunder. All of FMI’s employees, officers and consultants have executed agreements requiring assignment to FMI of all Inventions made by such individuals during the course of and as a result of their association with FMI.

13.1.6

Grants

FMI warrants and represents that to the best of FMI’s knowledge and belief, FMI has the lawful right to grant Roche and its Affiliates the rights and licenses described in this Agreement.

13.1.7

Valid Claims

As of the Effective Date, FMI warrants and represents that it is not in possession of any information that would, in its reasonable opinion, render invalid and/or unenforceable any claims in any issued patent licensed pursuant to this Agreement. FMI has no knowledge of any inventorship disputes concerning any FMI Patent Rights.

13.1.8

Ownership and Validity of Know-How

As of the Effective Date, FMI warrants and represents that FMI’s Know-How relating to Products and Service Activities is legitimately in the possession of FMI and has not been misappropriated from any Third Party, and FMI has taken reasonable measures to protect the confidentiality of its Know-How.

 

13.2

Mutual Representations of the Parties

13.2.1

Authorization

As of the Effective Date and the Restatement Date, each Party warrants and represents to the other Party that the execution, delivery and performance of this Agreement by such Party and all instruments and documents to be delivered by such Party hereunder: (i) are within the corporate power of such Party; (ii) have been duly authorized by all necessary or proper corporate action; (iii) are not in contravention of any provision of the certificate of formation or limited liability company agreement of such Party; (iv) to the knowledge of such Party, will not violate any law or regulation or any order or decree of any court of governmental instrumentality; (v) will not violate the terms of any indenture, mortgage, deed of trust, lease, agreement, or other instrument to which such Party is a party or by which such Party or any of its property is bound, which violation would have a material adverse effect on the financial condition of such Party or on the ability of

 

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such Party to perform its obligations hereunder; and (vi) do not require any filing or registration with, or the consent or approval of, any governmental body, agency, authority or any other person, which has not been made or obtained previously (other than approvals required under the HSR Act, Regulatory Approvals required for the sale of Products and filings with Regulatory Authorities required in connection with Products).

13.2.2

No Claims

As of the Effective Date and the Restatement Date, each Party warrants and represents to the other Party that there are no claims or investigations (other than with respect to the Parties’ HSR filings), pending or threatened against such Party or any of its Affiliates, at law or in equity, or before or by any governmental authority relating to the matters contemplated under this Agreement or that would materially adversely affect such Party’s ability to perform its obligations hereunder.

13.2.3

No Conflict

Each Party warrants and represents that neither it nor any of its Affiliates is or will be under any obligation to any person, contractual or otherwise, that is conflicting with the terms of this Agreement or that would impede the fulfillment of such Party’s obligations hereunder.

13.2.4

Activities

Each Party will perform all activities under this Agreement (i) in a professional manner, (ii) in conformance with the level or care and skill ordinarily exercised by other professional institutions in similar circumstances, and (iii) in compliance with Applicable Law.

 

 

14.

Indemnification

14.1

Indemnification by Roche

Roche shall indemnify, hold harmless and defend FMI and its Affiliates, and their respective directors, officers, employees, independent contractors and agents from and against any and all losses, expenses, cost of defense (including without limitation attorneys' fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts FMI becomes legally obligated to pay because of any claim or claims brought by a Third Party against it to the extent that such claim or claims arise out of any member of the Roche Group’s actions or inactions in connection with activities under this Agreement, except to the extent such losses, expenses, costs and amounts are due to the gross negligence or willful misconduct or failure to act of FMI.

 

14.2

Indemnification by FMI

FMI shall indemnify, hold harmless and defend Roche and its Affiliates, and their respective directors, officers, employees, independent contractors and agents from and against any and all losses, expenses, cost of defense (including without limitation attorneys' fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts Roche becomes legally obligated to pay because of any claim or claims brought by a Third Party against it to the extent that such claim or claims arise out of FMI’s and its Affiliates’ actions or inactions in connection with activities under this Agreement, except to the extent such losses, expenses, costs and amounts are due to the gross negligence or willful misconduct or failure to act of Roche.

 

 

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14.3

Procedure

In the event of a claim by a Third Party against a Party entitled to indemnification under this Agreement (“ Indemnified Party ”), the Indemnified Party shall promptly notify the other Party (“ Indemnifying Party ”) in writing of the claim , and the Indemnifying Party shall undertake and solely manage and control, at its sole expense, the defense of the claim and its settlement. The Indemnified Party shall cooperate with the Indemnifying Party and may, at its option and expense, be represented in any such action or proceeding by counsel of its choice. The Indemnifying Party shall not be liable for any litigation costs or expenses incurred by the Indemnified Party without the Indemnifying Party’s written consent. The Indemnifying Party shall not settle any such claim unless such settlement fully and unconditionally releases the Indemnified Party from all liability relating thereto, unless the Indemnified Party otherwise agrees in writing.

 

15.

Liability

15.1

Disclaimer

EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY PROVIDES ANY WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS OR IMPLIED. FMI AND ROCHE DISCLAIM ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO EACH OF THEIR RESEARCH, DEVELOPMENT AND COMMERCIALIZATION EFFORTS HEREUNDER, INCLUDING, WITHOUT LIMITATION, WHETHER THE PRODUCTS CAN BE SUCCESSFULLY DEVELOPED OR MARKETED, THE ACCURACY, PERFORMANCE, UTILITY, RELIABILITY, TECHNOLOGICAL OR COMMERCIAL VALUE, COMPREHENSIVENESS, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE WHATSOEVER OF THE PRODUCTS. EXCEPT IN THE CASE OF A BREACH OF ARTICLE 16, AND WITHOUT LIMITING THE PARTIES’ OBLIGATIONS UNDER ARTICLE 14, IN NO EVENT SHALL EITHER FMI OR ROCHE BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT BASED ON CONTRACT, TORT OR ANY OTHER LEGAL THEORY.

 

 

16.

Obligation Not to Disclose Confidential Information

16.1

Non-Use and Non-Disclosure

During the Agreement Term and for […***…] thereafter, a Receiving Party shall (i) treat Confidential Information provided by Disclosing Party as it would treat its own information of a similar nature, (ii) take all reasonable precautions not to disclose such Confidential Information to Third Parties, without the Disclosing Party’s prior written consent, and (iii) not use such Confidential Information other than for fulfilling its obligations under this Agreement. If any Confidential Information is required to be disclosed by the Receiving Party or its Affiliates to comply with a court or administrative order, the Receiving Party or its Affiliates will provide prompt notice to the Disclosing Party to enable the Disclosing Party to resist such disclosure.

 

16.2

Permitted Disclosure

Notwithstanding the obligation of non-use and non-disclosure set forth in Section 16.1, the Parties recognize the need for certain exceptions to this obligation, specifically set forth below, with respect to press releases, patent rights, publications, and certain commercial considerations.

 

16.3

Press Releases

Each Party shall provide the other with a copy of any draft press release related to the activities contemplated by this Agreement at least […***…] prior to its intended publication for such other Party's review. The reviewing Party may provide the releasing Party with suggested modification to the draft press release. The releasing Party shall consider, and shall not unreasonably disregard, the reviewing Party’s suggestions in issuing its press release.

 

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16.4

Publications

During the Agreement Term, the following restrictions shall apply with respect to disclosure by any Party of Confidential Information relating to the Product in any publication or presentation:

a)

Both Parties acknowledge that it is their policy for the studies and results thereof to be registered and published in accordance with their internal guidelines. The Parties shall have the right to jointly publish all studies, clinical trials and results conducted or generated in accordance with this Agreement to the extent both Parties have jointly participated in or collaborated in such clinical study or trial.  To the extent any study or clinical trial is conducted solely by Roche with no participation by FMI, Roche, in accordance with its internal policies and procedures, shall have the right to publish all such studies, clinical trials and results thereof on the clinical trial registries that are maintained by or on behalf of Roche, and FMI shall not publish any such studies, clinical trials or results thereof on its clinical trial registry, provided however, the Roche’s clinical trial registry can be accessed via a link from FMI’s clinical trial registry.

b)

A Party (" Publishing Party ") shall provide the other Party with a copy of any proposed publication or presentation at least […***…] prior to submission for publication so as to provide such other Party with an opportunity to recommend any changes it reasonably believes are necessary to continue to maintain the Confidential Information disclosed by the other Party to the Publishing Party in accordance with the requirements of this Agreement. The incorporation of such recommended changes shall not be unreasonably refused; and if such other Party notifies (" Publishing Notice ") the Publishing Party in writing, within […***…] after receipt of the copy of the proposed publication or presentation, that such publication or presentation in its reasonable judgment (i) contains an invention, solely or jointly conceived and/or reduced to practice by the other Party, for which the other Party reasonably desires to obtain patent protection or (ii) could be expected to have a material adverse effect on the commercial value of any Confidential Information disclosed by the other Party to the Publishing Party, the Publishing Party shall prevent such publication or delay such publication for a mutually agreeable period of time. In the case of inventions, a delay shall be for a period reasonably sufficient to permit the timely preparation and filing of a patent application(s) on such invention, and in no event less than […***…] from the date of the Publishing Notice.

 

16.5

Commercial Considerations

Nothing in this Agreement shall prevent a Party or its Affiliates from disclosing Confidential Information of the other Party to (i) governmental agencies to the extent required or desirable to secure government approval for the manufacture or sale of Product in the Territory, and (ii) Third Parties acting on behalf of such Party , to the extent reasonably necessary to conduct the activities contemplated by this Agreement, provided such Third Parties are bound by confidentiality and non-use obligations with respect to such information that are no less stringent than those included in this Agreement. The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with Applicable Law, to defend or prosecute litigation or to comply with governmental regulations, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party and, to the extent practicable, takes reasonable and lawful actions to minimize the degree of such disclosure .

 

 

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17.

Term and Termination

17.1

Commencement and Term

This Agreement shall commence upon the Effective Date and continue for the Agreement Term.

 

17.2

Termination

17.2.1

Automatic Termination

This Agreement shall terminate automatically, without any notice or other action by any Party, upon the first to occur of (i) termination of the Transaction Agreement in accordance with its terms and (ii) the mutual written consent of the Parties.

17.2.2

Termination for Breach

A Party (“ Non-Breaching Party ”) shall have the right to terminate this Agreement in its entirety or on a country-by-country or Product-by-Product basis in the event the other Party (“ Breaching Party ”) is in breach of any of its material obligations under this Agreement. The Non-Breaching Party shall provide written notice to the Breaching Party, which notice shall identify the breach and, if applicable, the affected countries in which, and the affected Products with respect to which, the Non-Breaching Party intends to have this Agreement terminate. The Breaching Party shall have a period of […***…] after such written notice is provided (“ Peremptory Notice Period ”) to cure such breach. If the Breaching Party has a dispute as to whether such breach occurred or has been cured, it will so notify the Non-Breaching Party, and the expiration of the Peremptory Notice Period shall be tolled until the Parties agree or the arbitrators have determined in accordance with Section 19.3 that this Agreement was materially breached. It is understood and acknowledged that, during the pendency of such a dispute, all of the terms and conditions of this Agreement shall remain in effect, and the Parties shall continue to perform all of their respective obligations under this Agreement.  Upon such agreement or determination of material breach or failure to cure, the Breaching Party may have the remainder of the Peremptory Notice Period to cure such breach. If such breach is not cured within the Peremptory Notice Period, then , absent withdrawal of the Non-Breaching Party’s request for termination, this Agreement shall terminate in accordance with the written notice provided by the Non-Breaching Party and such termination shall be effective as of the expiration of the Peremptory Notice Period. For clarity, (a) Roche may terminate this Agreement under this Section 17.2.2 if there is a material diminution in the Quality Standards, except as permitted under Section 2.3, or if FMI is unwilling or unable to fulfill its obligations under Section 7.5.2, and (b) FMI may terminate this Agreement under this Section 17.2.2 if Roche is unwilling or unable to fulfill its obligations under Section 7.6.1 and FMI may terminate this Agreement on a country-by-country basis in the event of a Territory Revision Event. Notwithstanding the foregoing, Roche may terminate this Agreement under this Section 17.2.2 if a Material Average Delivery Time Failure or Material Performance Standards Failure occurs by providing written notice to FMI within […***…] of such Material Average Delivery Time Failure or Material Performance Standards Failure, and no cure period as provided under this Section 17.2.2 shall be applicable for such termination.

17.2.3

Insolvency

A Party shall have the right to terminate this Agreement, if the other Party incurs an Insolvency Event; provided, however, in the case of any involuntary bankruptcy proceeding, such right to terminate shall only become effective if the Party that incurs the Insolvency Event consents to the involuntary bankruptcy or such proceeding is not dismissed within […***…] after the filing thereof.

 

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17.2.4

Termination by Roc he without a Cause

Roche shall have the right to terminate this Agreement at any time after the Initial Term on a Product-by-Product and/or country-by-country basis upon […***…] prior written notice. The effective date of termination under this Section 17.2.4 shall be the date […***…] after Roche provides such written notice to FMI.

 

17.3

Consequences of Termination and Expiration

17.3.1

Termination by FMI for Breach by Roche or by Roche without a Cause, or Expiration of the Agreement Term.

Upon any termination under Section 17.2.1, any termination by FMI for breach by Roche in accordance with Section 17.2.2 , any termination by Roche under Section 17.2.4, any Territory Revision Event, or upon expiration of the Agreement Term, the following shall apply:

 

a)

The rights and licenses granted by FMI to Roche under this Agreement shall terminate in their entirety or on a country-by-country basis, as applicable, on the effective date of termination.

 

b)

After the effective date of termination , Roche shall, to the extent permitted by Applicable Law , assign and transfer to FMI all regulatory filings and Regulatory Approvals, all final pre-clinical and clinical study reports and clinical study protocols, and all data, including clinical data, in Roche’s possession and control related to Product(s) in the country necessary for FMI to continue to commercialize the Product(s). All data shall be transferred in the form and format in which it is maintained by Roche. Original paper copies shall only be transferred, if legally required. Roche shall not be required to prepare or finalize any new data, reports or information solely for purposes of transfer to FMI.

 

c)

Roche shall assign all clinical trial agreements, to the extent such agreements have not been cancelled and are assignable without Roche paying any consideration or commencing litigation in order to effect an assignment of any such agreement.

 

d)

FMI shall, upon transfer, have the right to disclose such filings, approvals and data to (i) governmental agencies of the country to the extent required or desirable to secure government approval for the sale of Product(s) in the country, (ii) Third Parties acting on behalf of FMI, its Affiliates or licensees, to the extent reasonably necessary for the sale of Product(s) in the country, and (iii) Third Parties to the extent reasonably necessary to market Product(s) in the country.

17.3.2

Termination by Roche for Breach by FMI or FMI Insolvency

Upon a material breach of a material obligation under this Agreement by FMI pursuant to Section 17.2.2 or FMI’s Insolvency pursuant to Section 17.2. 3 , at Roche’s option, (i) Roche may seek damages via arbitration under Section 19.3 or (ii) as Roche’s exclusive remedy (other than for breach of confidentiality under Section 16) FMI shall pay to Roche either a one-time payment reflecting the value of the terminated Product(s) or a royalty on sales of such terminated Product(s) based on the royalty that Roche would have paid to FMI had the Agreement not terminated, the amount of which will be agreed to by the Parties negotiating in good faith. If the Parties cannot agree on the amount in clause (ii) above, then the determination of such amount shall be referred to a Panel in a manner analogous to that found in Section 8.3.5.

 

 

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Upon any termination by Roche for breach by FMI in accordance with Section 17.2. 2 or for FMI’s insolvency in accordance with Section 17.2. 3 , the following shall apply:

 

 

a)

the rights and licenses granted by FMI to Roche under this Agreement shall terminate in their entirety or on a country-by-country and Product-by-Product basis, as applicable, on the effective date of termination.

 

 

b)

After the effective date of termination Roche shall, to the extent Roche has the right to do so, assign and transfer to FMI all regulatory filings and Regulatory Approvals, all final pre-clinical and clinical study reports and clinical study protocols, and all data, including clinical data, in Roche’s possession and control related to Product(s) in the country necessary for FMI to continue to commercialize the Product(s). All data shall be transferred in the form and format in which it is maintained by Roche. Original paper copies shall only be transferred, if legally required. Roche shall not be required to prepare or finalize any new data, reports or information solely for purposes of transfer to FMI.

 

 

c)

Roche shall assign all clinical trial agreements, to the extent such agreements have not been cancelled and are assignable without Roche paying any consideration or commencing litigation in order to effect an assignment of any such agreement.

 

 

d)

FMI shall, upon transfer, have the right to disclose such filings, approvals and data to (i) governmental agencies of the country to the extent required or desirable to secure government approval for the sale of Product(s) in the country, (ii) Third Parties acting on behalf of FMI, its Affiliates or licensees, to the extent reasonably necessary for the sale of Product(s) in the country, and (iii) Third Parties to the extent reasonably necessary to market Product(s) in the country .

17.3.3

Direct License

Upon termination of this Agreement pursuant to Sections 17.2.2 or 17.2.3, with respect to any existing, permitted sublicense granted by Roche under Section 2.1.2(ii) of this Agreement (and any further sublicenses thereunder) upon the written request of Roche, (i) if the sublicense was consented to by FMI or is to Chugai, then the sublicense shall survive termination provided such Sublicensee (a) is not then in breach of its sublicense agreement and (b) such Sublicensee agrees to be bound to FMI under the terms and conditions of such sublicense agreement, and (ii) if the sublicense was not consented to by FMI, then FMI shall negotiate in good faith with the applicable Sublicensee the terms under which such sublicense shall survive such termination, provided that (a) such Sublicensee is not then in breach of its sublicense agreement (and, in the case of termination by FMI for breach by Roche, that such Sublicensee and any further sublicensees did not cause the breach that gave rise to the termination by FMI); and (b) such Sublicensee agrees to be bound to FMI under the terms and conditions of such sublicense agreement.

17.3.4

Other Obligations

17.3.4.1

Obligations Related to Ongoing Activities

Upon the effective date of termination of this Agreement, each Party (a) shall have the right to cancel all ongoing obligations as of the effective date of termination and (b) shall complete all non-cancellable obligations at its own expense.

 

 

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From the date of notice of termination until the effective date of termination, Roche and FMI shall each continue their activities, including preparatory activities, ongoing as of the date of notice of termination. However, neither Party shall be obliged to initiate any new activities not ongoing at the date of notice of termination.

 

After the effective date of termination, neither Party shall have an obligation to perform and/or complete any activities or to make any payments for performing or completing any activities after such effective date of termination under this Agreement, except as expressly stated herein.

 

Notwithstanding the foregoing, (a) in case of termination by FMI under Section 17.2.2 or 17.2.3 or by Roche under Section 17.2.4, upon the request of FMI, Roche shall complete any clinical studies related to the Product(s) that are being conducted by Roche for the Product(s) and are ongoing as of the effective date of termination, and (b) in case of termination by Roche under Section 17.2.2 or 17.2.3, upon the request of Roche, FMI shall complete any clinical studies related to the Product(s) that are being conducted by FMI for the Product(s) and are ongoing as of the effective date of termination; provided, however, that

 

(i)

both FMI and Roche in their reasonable judgment have concluded that completing any such clinical studies does not present an unreasonable risk to patient safety;

 

(ii)

neither Party shall have an obligation to recruit or enroll any additional patients after the effective date of termination; and

 

(iii)

FMI agrees to reimburse Roche for all of its development costs that incurred by or on behalf of Roche after the effective date of termination in completing such clinical studies as per subsection (a) above and Roche agrees to reimburse FMI for all of its development costs that incurred by or on behalf of Roche after the effective date of termination in completing such clinical studies as per subsection (b) above.

17.3.4.2

Ancillary Agreements

Unless otherwise agreed by the Parties, the termination of this Agreement shall cause the automatic termination of all ancillary agreements related hereto, including but not limited to supply or quality agreements, if any, but shall not cause the termination of the Related Agreements unless specifically stated in such Related Agreement.

17.3.4.3

Limitations on Grant-Backs; Transfer Expenses

For purposes of clarity, irrespective of anything to the contrary in this Agreement:

 

a)

All transfers and licenses from Roche to FMI or other obligations of Roche under Section 17.3 are solely with respect to Product(s).

 

b)

In connection with clinical trials, Roche may have collected human samples and related clinical information for additional limited research and development programs (“ Samples ”). Legal and contractual restrictions may apply to such Samples, in particular as Samples may qualify as personal identifiable information. FMI acknowledges and accepts that notwithstanding anything herein, Roche shall not be obliged to transfer any such Samples to FMI.

 

 

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c)

Nothing in this Agreement shall be construed as granting FMI any license under the intellectual property of Roche or its Affiliates in existence as of the Effective Date .

 

d)

Except with respect to termination by FMI for Roche’s breach pursuant to Section 17.2.2, FMI shall promptly reimburse Roche for all reasonable out-of-pocket costs and expenses (including FTE charges based on Roche’s actual FTE Rates, not to exceed the FTE Rates set forth in the Collaboration Agreement ) incurred by or on behalf of Roche for transfer of documents and materials as requested by FMI under this Article 17 (“ Roche Transfer Activities ”); however transfer activities corresponding to the return of material remains, data, reports, records, documents, Regulatory Filings and Regulatory Approvals originally provided by FMI to Roche (“ FMI-Originated Transfer Activities ”) shall be at no expense to FMI. If FMI desires Roche Transfer Activities other than FMI-Originated Transfer Activities, FMI shall make a payment to Roche of […***…] (“ Minimum Transfer Payment ”). The Minimum Transfer Payment shall be non-refundable, but shall be fully creditable against FMI’s reimbursement for the Roche Transfer Activities. Roche shall be under no obligation to provide Roche Transfer Activities (beyond the FMI-Originated Transfer Activities) prior to receipt of the Minimum Transfer Payment.

17.3.5

Royalty and Payment Obligations

Termination of this Agreement by a Party, for any reason, shall not release Roche from any obligation to pay royalties or make any payments to FMI that are payable for sales of Product prior to the effective date of termination. Termination of this Agreement by a Party, for any reason, will release Roche from any obligation to pay royalties or make any payments to FMI that would otherwise become payable on or after the effective date of termination.

 

17.4

Survival

Article 1 (Definitions, to the extent necessary to interpret the Agreement), Section 6.1.2.3 (Firewall, to the extent necessary to protect Third Party information not in the public domain), Article 10 (Taxes) Article 11 (Auditing), Article 12 (Intellectual Property, to the extent relating to intellectual property existing at the time of termination), Article 14 (Indemnification, to the extent relating to claims existing at the time or termination), Article 16 (Obligation Not to Disclose Confidential Information), Section 17.3 (Consequences of Termination and Expiration, to the extent applicable), Section 17.4 (Survival), Section 19.1 (Governing Law) and Section 19.3 (Arbitration) shall survive any expiration or termination of this Agreement for any reason. Notwithstanding the foregoing, any provision of this Agreement that is intended by its very nature to survive expiration or termination of this Agreement shall also survive.

 

 

18.

Bankruptcy

All licenses (and to the extent applicable rights) granted under or pursuant to this Agreement by FMI to Roche are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11, US Code (the “ Bankruptcy Code ”) licenses of rights to “intellectual property” as defined under Section 101(60) of the Bankruptcy Code. Unless Roche elects to terminate this Agreement, the Parties agree that Roche, as a licensee or sublicensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code, subject to the continued performance of its obligations under this Agreement.

 

 

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19.

Miscellaneous

19.1

Governing Law

This Agreement shall be governed by and construed in accordance with the laws of New York, US, without reference to its conflict of laws principles, and shall not be governed by the United Nations Convention on International Contracts on the Sale of Goods (the Vienna Convention).

 

19.2

Disputes

Unless otherwise set forth in this Agreement, in the event of any dispute in connection with this Agreement, such dispute shall be referred to the respective executive officers of the Parties designated below or their designees, for good faith negotiations attempting to resolve the dispute. The designated executive officers are as follows:

For FMI: CEO

 

For Roche:

Head of Roche Partnering or the CEO of the Roche Group in the case of Minimum Revenue Requirements.

 

19.3

Arbitration

Should the Parties fail to agree within […***…] after such dispute has first arisen, it shall be finally settled by arbitration in accordance with the American Arbitration Association (“AAA ”) Commercial Rules (the “ AAA Arbitration Rules ”) as in force at the time when initiating the arbitration. The tribunal shall consist of three arbitrators. The place of arbitration shall be New York, New York, US. The language to be used shall be English.

19.3.1

Arbitration

Each Party shall nominate one arbitrator. Should the claimant fail to appoint an arbitrator in the request for arbitration within […***…] of being requested to do so, or if the respondent should fail to appoint an arbitrator in its answer to the request for arbitration within […***…] of being requested to do so, the other Party shall request the AAA to make such appointment.

 

The arbitrators nominated by the Parties shall, within […***…] from the appointment of the arbitrator nominated in the answer to the request for arbitration, and after consultation with the Parties, agree and appoint a third arbitrator, who will act as a chairman of the tribunal. Should such procedure not result in an appointment within the […***…] time limit, either Party shall be free to request the AAA to appoint the third arbitrator.

 

Where there is more than one claimant and/or more than one respondent, the multiple claimants or respondents shall jointly appoint one arbitrator.

 

Any Party-appointed arbitrator or the third arbitrator resigns or ceases to be able to act, a replacement shall be appointed in accordance with the arrangements provided for in this clause.

 

The language of the arbitration shall be English. Documents submitted in the arbitration (the originals of which are not in English) shall be submitted together with an English translation.

19.3.2

Decision; Timing of Decisions

The arbitrators shall render a written opinion setting forth findings of fact and conclusions of law with the reason therefor stated, within no later than […***…] from the date on which the arbitrators were appointed to the dispute. A transcript of the evidence adduced at the arbitration hearing shall be made and, upon request, shall be made available to each Party.

 

 

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The time periods set forth in the AAA Arbitration Rules shall be followed; provided , however that the arbitrators may modify such time periods as reasonably necessary to render a written opinion in accordance with this Section 19.3.2.

 

The Arbitrator is empowered to award any remedy allowed by law, including money damages, prejudgment interest and attorneys’ fees, and to grant final, complete, interim, or interlocutory relief, including injunctive relief.

 

This arbitration agreement does not preclude either Party seeking conservatory or interim measures from any court of competent jurisdiction including, without limitation, the courts having jurisdiction by reason of either Party's domicile. Conservatory or interim measures sought by either Party in any one or more jurisdictions shall not preclude the arbitral tribunal from granting conservatory or interim measures. Conservatory or interim measures sought by either Party before the tribunal shall not preclude any court of competent jurisdiction granting conservatory or interim measures.

 

In the event that any issue shall arise which is not clearly provided for in this Section 19.3, the matter shall be resolved in accordance with the AAA Arbitration Rules.

 

Any arbitration proceeding hereunder shall be confidential and the arbitrators shall issue appropriate protective orders to safeguard each Party’s Confidential Information. Except as required by Applicable Law , neither Party shall make (or instruct the arbitrators to make) any public announcement with respect to the proceedings or decision of the arbitrators without prior written consent of the other Party. The existence of any dispute submitted to arbitration, and the award, shall be kept in confidence by the Parties and the arbitrators, except as required in connection with the enforcement of such award or as otherwise required by Applicable Law.

 

Notwithstanding anything to the contrary in this Agreement, any and all issues regarding the scope, construction, validity and/or enforceability of any Patent Rights shall be determined in a court of competent jurisdiction under the local patent laws of the jurisdictions having issued the Patent Rights in question.

 

Notwithstanding anything to the contrary in this Agreement, any and all issues regarding a breach or alleged breach of a Party’s obligations under Article 16 (Obligation Not to Disclose Confidential Information) shall be determined in a court of competent jurisdiction under the laws of New York, with express exclusion of its conflict of laws principles.

 

19.4

Assignment

Neither Party shall have the right to assign the present Agreement or any part thereof to any Third Party other than Affiliates without the prior written approval of the other Party.

 

19.5

Compliance with Applicable Law

Each Party shall comply with Applicable Law in conducting activities and carrying out responsibilities under this Agreement , including the U.S. Foreign Corrupt Practices Act of 1977 ( as amended, collectively hereinafter the “ FCPA ”) and anti-bribery laws in the countries in the Territory where Roche has its principal place of business and where it conducts activities under this Agreement.

 

 

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19.6

Debarment

Each Party represents and warrants that it has never been debarred under 21 U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal Health Care Program (as defined in 42 U.S.C §1320 a-7b(f)), including without limitation the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar Federal or state agency or program. In the event a Party receives notice of debarment, suspension, sanction, exclusion, ineligibility or disqualification under the above-referenced statutes, such Party shall […***…].

 

Each Party agrees that, to the best of its knowledge, none of its employees or agents conducting activities on its behalf under the Agreement is currently or will be during the Agreement Term , debarred under 21 U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal Health Care Program (as defined in 42 U.S.C §1320 a-7b(f)), including without limitation the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar Federal or state agency or program. In the event a Party learns that any such employee or agent becomes so debarred, sanctioned, suspended, excluded or declared ineligible or is the subject of proceedings that may result in such debarment, sanction, suspension, exclusion or ineligibility, it will promptly so notify the other Party and will no longer allow such employee or agent to conduct activities under this Agreement.

 

19.7

Independent Contractor

No employee or representative of either Party shall have any authority to bind or obligate the other Party to this Agreement for any sum or in any manner whatsoever or to create or impose any contractual or other liability on the other Party without said Party's prior written approval. For all purposes, and notwithstanding any other provision of this Agreement to the contrary, FMI legal relationship to Roche under this Agreement shall be that of independent contractor.

 

19.8

Unenforceable Provisions and Severability

If any of the provisions of this Agreement are held to be void or unenforceable, then such void or unenforceable provisions shall be replaced by valid and enforceable provisions that will achieve as far as possible the economic business intentions of the Parties. However the remainder of this Agreement will remain in full force and effect, provided that the material interests of the Parties are not affected, i.e. the Parties would presumably have concluded this Agreement without the unenforceable provisions.

 

19.9

Waiver

The failure by either Party to require strict performance and/or observance of any obligation, term, provision or condition under this Agreement will neither constitute a waiver thereof nor affect in any way the right of the respective Party to require such performance and/or observance. The waiver by either Party of a breach of any obligation, term, provision or condition hereunder shall not constitute a waiver of any subsequent breach thereof or of any other obligation, term, provision or condition.

 

19.10

Appendices

All Appendices to this Agreement shall form an integral part to this Agreement.

 

 

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19.11

Entire Understanding

This Agreement contains the entire understanding between the Parties hereto with respect to the within subject matter and supersedes any and all prior agreements, understandings and arrangements, whether written or oral , including the Original Agreement.

 

19.12

Amendments

No amendments of the terms and conditions of this Agreement shall be binding upon either Party hereto unless in writing and signed by both Parties.

 

19.13

Invoices

All invoices that are required or permitted hereunder shall be in writing and sent by FMI to Roche at the following address or other address as Roche may later provide:

 

F. Hoffmann-La Roche Ltd

Kreditorenbuchhaltung

4070 Basel

Switzerland

 

19.14

Notice

All notices that are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:

 

if to FMI, to:

Foundation Medicine, Inc.

150 Second Street

Cambridge, MA 02141

Attn: Legal Department

Facsimile No.: (617) 418-2201

 

if to Roche, to:

F. Hoffmann-La Roche Ltd

Grenzacherstrasse 124

4070 Basel

Switzerland

Attn: Legal Department Facsimile No.: +41 61 688 13 96

 

or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. The effective date of any notice shall be: (a) the date of the addressee’s receipt, if delivered personally, by courier, or by registered or certified mail; or (b) the date of receipt if received by 5:00 p.m. local time on a Business Day or, if not, the first Business Day after receipt, if sent by facsimile.

 

19.15

Subcontractors

Subject to Section 2.1.2 , either Party may perform any of its obligations under this Agreement, including under the Tactical Plans , Post Approval Plans, and F1CDx Initial Launch Plans, through one or more subcontractors or consultants; provided that (i) such Party remains responsible for the work allocated to, and payment to, such subcontractors and consultants to the same extent it would if it had done such work itself, and such Party shall be liable for any act or omission of such subcontractor and consultant that is a breach of any of such Party’s obligations under this

 

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Agreement as though the same were a breach by such Party, and the other Party shall have the right to proceed directly against such Party without any obligation to first proceed against such subcontractor or consultant; (ii) the subcontractor or consultant undertakes in writing commercially reasonable obligations of confidentiality and non-use regarding Confidential Information, that are substantially the same as those undertaken by the Parties with respect to Confidential Information pursuant to Article 16 hereof; and (iii) the subcontractor or consultant undertakes in writing to assign or exclusively license back (with the right to sublicense) all intellectual property with respect to Product developed in the course of performing any such work under the Tactical Plans , Post Approval Plans , and F1CDx Initial Launch Plans to the subcontracting Party. Notwithstanding the above, if the work to be done by the subcontractor or consultant is material to the performance of a Party und er this Agreement, then the Party engaging such subcontractor or consultant shall seek the consent of the other Party, which consent shall not be unreasonably withheld.

 

19.16

Force Majeure

Both Parties shall be excused from the performance of their obligations under this Agreement to the extent that such performance is prevented or delayed by force majeure and the nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition. For purposes of this Agreement, force majeure means conditions beyond the reasonable control of the Parties, including an act of God, war, civil commotion, terrorist act, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe, and failure of plant or machinery (provided that such failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances). Notwithstanding the foregoing, a Party shall not be excused from making payments owed hereunder because of a force majeure affecting such Party.

 

19.17

Rules of Construction

Each of the terms “including,” “include,” and “includes” as used herein shall mean including, without limiting the generality of any description preceding each such term.  As used herein, the term “day” shall mean a calendar day.

 

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IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the Restatement Date.

 

Foundation Medicine, Inc.

 

 

 

/s/ Melanie Nallicheri

 

Name:

 

Melanie Nallicheri

 

Title:

 

CBO & Head Biopharma

 

Date:

 

February 28, 2018

 

 

 

F. Hoffmann-La Roche Ltd

 

 

 

 

 

 

 

/s/ Dr. Joerg Kazenwadel

 

/s/ Stefan Arnold

Name:

 

Dr. Joerg Kazenwadel

 

Name:

Stefan Arnold

Title:

 

Head of R&D Out-Partnering

 

Title:

Head Legal Pharma

Date:

 

February 28, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Appendix 1. 22

Existing Third Party Rights

 

 

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Appendix 2.3

 

Product Specifications for the Initial Products as of the Effective Date

 

 

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Appendix 7.3.1

Countries where Roche has launched FoundationOne

as of the Restatement Date

 

 

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Appendix 7.7

Localization of Professional Services Section of F1CDx Report

 

Professional Services localization – in scope:

 

[…***…]

 

Professional Services localization – not in scope:

If so requested by Roche and permitted (or required) by Applicable Law, FMI shall not be required to make any localization changes not reflected in the “in scope” list above.  For the avoidance of doubt, the Parties agree that the following services are specifically not in scope:

 

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Exhibit 10.2

 

 

December 5, 2016

Michael Doherty

Re:

Employment with Foundation Medicine, Inc.

Dear Michael:

On behalf of Foundation Medicine, Inc. ( Foundation Medicine ” or “ the Company ”), I am very pleased to offer you the position of Head of Product Development.

The terms of your position with the Company are as set forth below in this letter agreement (“Agreement”):

1.

Position and Start Date . Your position at the Company will be Head of Product Development and a member of the Companies executive management team. In addition to performing duties and responsibilities associated with the position above, from time-to-time the Company may assign you other duties and responsibilities consistent with such position. You will begin your employment with the Company no later than January 2, 2017.

2.

Compensation and Related Matters .

 

a.

Base Salary . You will be paid on a salary basis at a rate of $14,615.38 per biweekly pay period, representing payment for all hours worked by you for Foundation Medicine, equivalent to an annualized base salary of approximately $380,000.00 (“Base Salary”). The Base Salary will be paid in accordance with Foundation Medicine’s standard payroll practices and subject to customary deductions and withholdings as required by law. You will be eligible to participate in annual merit salary reviews in accordance with the Company’s compensation practices. To be eligible for a merit increase, you must be
employed by September 30 of the previous year. This position is exempt, so you will not be eligible for overtime pay.

 

b.

Performance Incentive Payment. You will be eligible to participate in the Company’s annual performance incentive program, subject to its terms and conditions and at the discretion of the Company’s Board of Directors, with the potential to earn incentive

 

 


 

 

compensation equivalent to a target of up to 40% of your then annual Base Salary (“Annual Performance Incentive Target”). The performance incentive is based upon the achievement of Company performance, department performance, and individual performance objectives. The Company may also make adjustments in the Annual Performance Incentive Target in connection with a promotion and otherwise in its discretion. Except in connection with the payment to you of a Severance Payment, you must be employed by the Company at the time a performance incentive is paid to earn any part of an incentive.

 

c.

Expenses . The Company will reimburse your reasonable out-of-pocket travel expenses and other expenses related to your work in accordance with the Company’s expense reimbursement policy.

 

d.

Long Term Incentives. As an incentive for you to join Foundation Medicine and to share in the long-term growth of Foundation Medicine, you will be eligible to participate in a long-term incentive award program with two separate but complementary awards: a cash incentive award, and an equity incentive
award.  Both of these awards will vest over a four-year period.

Restricted Stock Units. Subject to approval by the Board of Directors (or a committee thereof) or the Chief Executive Officer of the Company, as may be required by the Company’s applicable governance rules, you will be granted an equity award of Restricted Stock Units (RSUs ) with an aggregate value of $1,750,000.00 ( Equity Award ”). The number of RSUs to be granted as part of the Equity Award will be calculated based on the 30-day average closing price of Foundation Medicine common stock ending on a date that is within five business days prior to the equity award approval date. The effective date for the grant will be the first day of the calendar quarter following your date of hire ( Equity Grant Date ”). Accordingly, based on your date of hire, the Equity Grant Date of the Equity Award will be one of January 1, April 1, July 1 or October 1. The Equity Award will vest over a four-year period as follows: 25% will vest on the first anniversary of the Equity Grant Date, and an additional 6.25% will vest on the first day of each subsequent quarter thereafter until 100% of the RSUs have vested. As a condition to receiving each portion of the Equity Award, you must
be an employee of Foundation Medicine as of the relevant vesting date and without any prior interruption of service. The Equity Award will be governed by
a restricted stock unit award agreement in the standard form approved by Foundation Medicine’s Board of Directors and shareholders, and will be subject to the provisions of Foundation Medicine’s then-current stock incentive plan (together with any other incentive equity plan(s), as may be amended from time to time, any associated award agreements, the “
Equity Documents ”).

Cash award: Subject to approval by the Board of Directors (or committee thereof) or the Chief Executive of the Company, as may be required by the Company’s applicable governance rules, you will be granted a cash award of $300,000.00 (“Cash Award”) effective on the first day of the calendar quarter following your date of hire (“Grant Date”). Based on your date of hire, the Grant

 

 


 

Date of the Cash Award will be one of January 1, April 1, July 1 or October. The Cash Award will vest over a four-year period as follow: 25% will vest on the first anniversary of the Grant Date, and an additional 12.5% will vest every six months thereafter until 100% of the Cash Award has vested. As a condition to receiving each Cash Award payment, you must be an employee of Foundation Medicine as of the relevant vesting date and without any prior interruption of service. The Cash Award will be subject to the provisions of Foundation Medicine’s then-current long term incentive cash award plan, as may be amended from time to time. Each Cash Award will be subject to customary deductions and
tax withholdings as required by law.

 

e.

Living Expense Assistance and Relocation. The Company requires that as a condition of employment, you relocate to Massachusetts. The Company will provide you with Living Expense Allowance, payable only in the form of reimbursement and not as an addition to your salary, on a monthly basis at the equivalent of $35,000 annually (the “Living Expense Allowance”). This Living Expense Allowance will reimburse you for living expenses, customary costs and food expenses (to the extent such food expenses are not otherwise reimbursable as a business expense under the Company’s business expense policy), in each instance as incurred in the Cambridge area (“Living Expenses”). The costs of any Living Expenses under or over the Living Expense Allowance shall not affect the amount of Living Expense Allowance eligible for reimbursement, and you shall not be entitled to any supplemental payment if the actual Living Expenses is less than the Living Expense Allowance. Travel expenses incurred in commuting between California and Cambridge, Massachusetts (“Commuting Expenses”) will be covered under the companies travel and expense reimbursement policy and will not be included in the Living Expense Assistance.

The Living Expense Assistance will expire on December 31, 2017. Upon expiration, the Company will no longer be required to provide you with Living Expense Assistance unless you and the Company have successfully renegotiated this provision, at the discretion of the CEO and the Head of Human Resources.

In addition to Living Expense Assistance, the Company will provide you with a relocation allowance (“Relocation Allowance”) of up to $75,000.00. The relocation allowance will be paid to you in the form of (“Relocation Expenses”). The expenses are subject to prior approval by the CEO and the Head of Human Resources. If you resign from the Company without Good Reason within 18 months after the receipt of the relocation assistance, you will reimburse the Company for the entirety of the amount of the Relocation Allowance paid to you within thirty (30) days of your last day of employment, in a check made payable to the Company.

The Company will determine in its reasonable judgment what, if any, of your Living Expenses, Commuting Expenses and Relocation Expenses paid for or reimbursed by the Company are taxable to you in accordance

 

 


 

with applicable law and will comply with associated withholding and tax reporting obligations. To the extent certain of these Living Expenses, Commuting Expenses and Relocation Expenses are deemed taxable by the IRS in a given year, the Company will provide you with a tax gross-up payment such that after payment of taxes (federal, state and employment) on such amount, there remains a balance sufficient to pay the taxes (federal, state and employment) on the amount of your taxable reimbursable Commuting Expenses and Living Expenses. The Company will make such tax gross-up payment promptly but in no event later than the end of the calendar year in which you remit the related taxes.

 

f.

Other Benefits . As a regular, full-time employee, you will be eligible to participate in the employee benefit program that Foundation Medicine offers to its employees in comparable positions, which currently include Health, Dental, Life and Disability Insurance, matching 401(k) Plan, and Sick Time, subject to plan terms and generally applicable Foundation Medicine policies. You will be also be entitled to accrue up to fifteen (15) days of vacation each calendar year and to such other holidays as Foundation Medicine recognizes for employees having comparable responsibilities and duties. For any calendar year in which you are employed with the Company for only a portion of such year, the vacation time will be pro-rated. Descriptions of the Company’s benefits will be available upon request. The Company retains the right to amend, modify, or cancel any benefits program. Where a particular benefit is subject to a formal plan (for example, medical insurance or 401(k)), eligibility to participate in and receive any particular benefit is governed solely by the applicable plan document.

3.

At-Will Employment . Your employment at all times shall remain “at will,” meaning that either you or the Company may terminate the employment relationship at any time, for any lawful reason, with or without cause.

4.

Non-Competition, Non-Solicitation, Confidentiality and Assignment Agreement . As part of your employment with Foundation Medicine, you will be exposed to, and provided with, valuable confidential and/or trade secret information concerning Foundation Medicine and its present and future business plans and operations. As a result, in order to protect Foundation Medicine’s substantial investment of time and money in the creation and maintaining of its confidential information and good-will with its customers, clients, and collaborators, your offer of employment is contingent upon your signing the Company’s Employee Non-Competition, Non-Solicitation, Confidentiality and Assignment Agreement (the “ Restrictive Covenant Agreement ”), a copy of which is attached to this Offer as Exhibit A and your continued willingness to abide by its terms.

By the same token, Foundation Medicine expects you to abide by and honor the terms of any agreements you may have with your present or prior employers. By signing below, you represent that you are not subject to any agreements which might restrict your conduct at the Company, and that you understand that if you become aware at any time during your employment with the Company that you are subject to any agreements which might restrict your activities at Foundation Medicine, you are required to immediately

 

 


 

inform the Company’s Senior Vice President, Human Resources of the existence of such agreements. In the event of an irresolvable conflict, your employment by Foundation Medicine could be subject to termination and such termination would be deemed a for “Cause” termination for purposes of this Agreement and the Equity Documents.

Also, just as Foundation Medicine regards the protection of our confidential information as a matter of great importance, we also respect that you may have an obligation to your present and/or prior employers to safeguard the confidential information of those companies. Foundation Medicine respects these obligations, and expects you to honor them as well. To that end, we expect that you have not taken any documents or other confidential information from your employer. Further, we want to make it perfectly clear you should not bring with you to Foundation Medicine, or use in the performance of your duties for our Company, any proprietary business or technical information, materials or documents of a former employer, or otherwise disclose or use any former employer’s confidential information.

5.

Work Authorization . This offer of employment is contingent on you being legally authorized to work in the United States, and you will need to complete an I-9 Employment Verification Form no later than your first day of work.

6.

Termination of Employment .

 

a.

Severance Payments . Without otherwise limiting the “at will” nature of your employment if: (i) your employment is terminated by the Company without Cause at any time, or (ii) within eighteen (18) months following a Change in Control you terminate your employment with the Company for Good Reason in accordance with the Good Reason Process, and, in either event, you enter into, do not revoke, and comply with a Release, the Company shall pay or provide you with: (a) Salary Continuation for twelve (12) months following your termination date (the “ Salary Continuation Period ”); (b) Health Care Continuation during the Salary Continuation Period; and (c) a Performance Incentive Payment equal to your current year Annual Performance Incentive Target, prorated based on the length of time that you have been employed with the Company during the calendar year in which your employment is terminated (collectively, the “ Severance Payments ”); provided and notwithstanding the foregoing, if your employment is terminated in connection with a Change in Control and you immediately become reemployed by any direct or indirect successor to the business or assets of the Company, the termination of your employment upon the Change in Control shall not be considered a Termination without Cause for purposes of this Agreement.

 

b.

Equity Acceleration . In the event that you become entitled to Severance Payments at any time within eighteen (18) months following a Change in Control, and you enter into, do not revoke, and comply with a Release, then all outstanding unvested equity-based compensation awards that have been granted acceleration rights and were granted to you under the Equity Documents prior to the Change in Control shall become exercisable and vested in full, and all restrictions thereon shall lapse, notwithstanding any vesting schedule or other provisions to the contrary in the

 

 


 

 

agreements evidencing such awards or in the underlying equity plan, and the Company and you hereby agree that any agreements covering such awards are hereby, and will be deemed to be, amended to give effect to this provision.

 

c.

Non-Eligibility for Severance Payments or Equity Award Acceleration . For the avoidance of doubt, you and the Company acknowledge that if your employment is terminated: (i) by the Company for Cause, (ii) by you without Good Reason, (iii) by you with Good Reason following a Change in Control but without complying with the Good Reason Process, or (iv) as a result of your death or disability, then, as a result of such termination, (w) you shall not be entitled to Severance Payments, (x) you shall be entitled to receive only base salary earned plus accrued but unused vacation pay through the date of termination, (y) the unvested portion of your Equity Awards will not accelerate, and (z) your Equity Awards shall expire or be forfeited in accordance with the terms of the Equity Documents.

7.

Definitions . For purposes of this Agreement, the following terms shall have the following meanings:

Company ” means Foundation Medicine, Inc., and its successors and assigns.

Cause ” means one or more of the following events: (i) your conviction of, or the entry of a pleading of guilty or nolo contendere to, any crime involving (A) fraud or embezzlement, or (B) any felony; (ii) your willful failure to perform (other than by reason of disability), or gross negligence in the performance of, your duties and responsibilities as set forth in your job description; (iii) a material breach by you of any provision of this Agreement, the Restrictive Covenant Agreement, or any of the other agreements you have with the Company; or (iv) material fraudulent conduct by you with respect to the Company.

Change in Control ” shall mean:

 

a.

any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “Act”) (other than the Company, any of its subsidiaries, or any trustee, fiduciary or other person or entity holding securities under any employee benefit plan or trust of the Company or any of its subsidiaries), together with all “affiliates” and “associates” (as such terms are defined in Rule 12b-2 under the Act) of such person, shall become the “beneficial owner” (as such term is defined in Rule 13d-3 under the Act), directly or indirectly, of securities of the Company representing 50 percent or more of the combined voting power of the Company’s then outstanding securities having the right to vote in an election of the Board (“ Voting Securities ”) (in such case other than as a result of an acquisition of securities directly from the Company);
or

 

b.

the date when a majority of the members of the Board of Directors of the Company is replaced by individuals who, prior to their election, or nomination for election by the Company’s shareholders, were not approved by a majority of the members of the

 

 


 

 

Board of Directors in existence on the date immediately prior to such election, appointment or nomination (excluding any individuals nominated by any member of the Investor Group (as defined in that certain Investor Rights Agreement, dated as of January 11, 2015 (as amended from time to time), by and among the Company, Roche Holdings, Inc. and certain other stockholders of the Company named therein (the Investor Rights Agreement ”)) following the occurrence of a Material Breach (as defined in the Investor Rights Agreement)); or

 

c.

the consummation of (A) any consolidation or merger of the Company where the stockholders of the Company, immediately prior to the consolidation or merger, would not, immediately after the consolidation or merger, beneficially own (as such term is defined in Rule 13d-3 under the Act), directly or indirectly, shares representing in the aggregate more than 50 percent of the voting shares of the Company issuing cash or securities in the consolidation or merger (or of its ultimate parent corporation, if any), or (B) any sale or other transfer (in one transaction or a series of transactions contemplated or arranged by any party as a single plan) of all or substantially all of the assets of the Company;
or

 

d.

the consummation by any member of the Investor Group of any tender or exchange offer, merger, consolidation, business combination or other similar transaction involving the Company that results in the Investor Group collectively owning all of the outstanding Voting Securities of the Company.

Notwithstanding the foregoing, a “Change in Control” shall not be deemed to have occurred for purposes of the foregoing clause (a), (i) solely as the result of an acquisition of securities by the Company which, by reducing the number of shares of Voting Securities outstanding, increases the proportionate number of Voting Securities beneficially owned by any person to 50 percent or more of the combined voting power of all of the then outstanding Voting Securities; provided, however, that if any person referred to in this sentence shall thereafter become the beneficial owner of any additional shares of Voting Securities (other than pursuant to a stock split, stock dividend, or similar transaction or as a result of an acquisition of securities directly from the Company) and immediately thereafter beneficially owns 50 percent or more of the combined voting power of all of the then outstanding Voting Securities, then a “Change in Control” shall be deemed to have occurred for purposes of the foregoing clause (a); or (ii) as a result of Roche’s acquisition of Voting Securities as provided under Section 4.03(a) and/or 4.04(b) of the Investor Rights Agreement.

Equity Award ” means all incentive stock options, non-statutory stock options, shares of restricted stock, restricted stock units or other incentive equity awards in respect of shares of the Company’s equity securities that have been or will be granted to you by the Company.

 

 


 

Good Reason means that you have complied with the “Good Reason Process” (hereinafter defined) following the occurrence of any of the following events in connection with a Change in Control: (i) a material diminution in your responsibilities, authority or duties; (ii) a material diminution in your Base Salary, except for across-the-board salary reductions based on the Company’s financial performance similarly affecting all or substantially all senior management employees of the Company; (iii) your principal work location is moved to a principal work location that is located more than fifty (50) miles from the work location at which you were principally working as of the effective date of the Change in Control; or (iv) the material breach of this Agreement by the Company.

Good Reason Process ” means that (i) you reasonably determine that a Good Reason condition has occurred, (ii) you notify the Company in writing of the first occurrence of the Good Reason condition within sixty (60) days of the first occurrence of such condition, (iii) you cooperate in good faith with the Company’s efforts (if such efforts are taken) for a period of not less than thirty (30) days following such notice (the “ Cure Period ”) to remedy the Good Reason condition, (iv) notwithstanding such efforts a material element of at least one Good Reason condition continues to exist, and (v) you terminate your employment within sixty (60) days after the end of the Cure Period. If the Company claims in a written notice to you to have fully cured the Good Reason condition during the Cure Period, and you have not contested the cure within sixty (60) days after receiving such notice, Good Reason shall be deemed not to have occurred. The Company’s success at curing a Good Reason condition shall not bar or preclude your right to notify the Company of the occurrence of another Good Reason condition and to proceed with the Good Reason Process.

Health Care Continuation ” means that if you are participating in the Company’s group health plan immediately prior to the date of your termination, then subject to your timely election and eligibility for benefits under the law known as COBRA, and any law that is the successor to COBRA, the Company shall continue to pay the employer portion of your health benefits until the earlier of the end of the Salary Continuation Period and the date you become re-employed or otherwise ineligible for COBRA.

Release ” shall mean a separation agreement in a form prescribed by the Company that includes, without limitation, (i) a general release of claims and non-disparagement covenant, both in favor of the Company and related persons and entities, (ii) reaffirmation of your obligations under the Employee Agreement, the terms of which will be incorporated by reference into the Release, and (iii) a provision stating that, if you breach any of the material provisions of Release, in addition to all other rights and remedies, the Company shall have the right to receive reimbursement for, or to terminate or cease payment of, Severance Payments paid or payable to you.

Salary Continuation ” means that the Company shall continue to pay you your base salary at the rate in effect on the date of termination during the Salary Continuation Period. The first payment of Salary Continuation shall be paid within sixty (60) days
after the date of termination and shall be made on the Company’s regular payroll dates; provided, however, that if the sixty (60) day period begins in one calendar year and ends

 

 


 

in a second calendar year, the first payment of Salary Continuation shall be paid in the second calendar year. In the event you miss one or more regular payroll periods between the date of termination and the first Salary Continuation payment, the first Salary Continuation payment shall include a “catch up” payment of accrued but unpaid Salary Continuation payments.

8.

Section 409A Compliance . To the extent that any Severance Payments or other benefits to you constitute “non-qualified deferred compensation” under Section 409A of the Internal Revenue Code of 1986 (as amended or replaced) (the “ Code ”), then such Severance Payments or benefits shall begin only upon or after the date of your “separation from service” (within the meaning of Section 409A of the Code), which may occur on or after the date of the termination of your employment. Neither the Company nor you shall have the right to accelerate or defer the delivery of any such payments except to the extent specifically permitted or required by Section 409A. Anything to the contrary notwithstanding, if at the time of your separation from service within the meaning of Section 409A of the Code, the Company determines that you are a “specified employee” within the meaning of Section 409A(a)(2)(B)(i) of the Code, then to the extent any payment or benefit that you become entitled to under this Agreement on account of your separation from service would be considered deferred compensation otherwise subject to the twenty percent (20%) additional tax imposed pursuant to Section 409A(a) of the Code as a result of the application of Section 409A(a)(2)(B)(i) of the Code, such payment shall not be payable and such benefit shall not be provided until the date that is the earlier of (i) six (6) months and one day after your separation from service, or (ii) the your death. If any such delayed cash payment is otherwise payable on an installment basis, the first payment shall include a catch-up payment covering amounts that would otherwise have been paid during the six (6)-month period but for the application of this provision, and the balance of the installments shall be payable in accordance with their original schedule. The determination of whether and when your “separation from service” from the Company has occurred shall be made in a manner consistent with, and based on the presumptions set forth in, Treasury Regulation Section 1.409A-l(h). Solely for purposes of this Section, “Company” shall include all persons with whom the Company would be considered a single employer under Sections 414(b) and 414(c) of the Code.

All in-kind benefits provided and expenses eligible for reimbursement under this Agreement shall be provided by the Company or incurred by you during the time periods set forth in this Agreement. All reimbursements shall be paid as soon as administratively practicable, but in no event shall any reimbursement be paid after the last day of the taxable year following the taxable year in which the expense was incurred. The amount of in-kind benefits provided or reimbursable expenses incurred in one taxable year shall not affect the in-kind benefits to be provided or the expenses eligible for reimbursement in any other taxable year (except for any lifetime or other aggregate limitation applicable to medical expenses). Such right to reimbursement or in-kind benefits is not subject to liquidation or exchange for another benefit.

The parties intend that this Agreement will be administered in accordance with Section 409A. To the extent that any provision of this Agreement is ambiguous as to its compliance with Section 409A, the provision shall be read in such a manner so that all

 

 


 

payments hereunder comply with Section 409A. Each payment pursuant to this Agreement is intended to constitute a separate payment for purposes of Treasury Regulation Section 1.409A-2(b)(2). The parties agree that this Agreement may be amended, as reasonably requested by either party, and as may be necessary to fully comply with Section 409A and all related rules and regulations in order to preserve the payments and benefits provided hereunder without additional cost to either party. The Company shall have no liability to you or to any other person if any provisions of this Agreement that are intended to be exempt from or compliant with Section 409A are not so exempt or compliant.

9.

Section 280G Limitation . Anything in this Agreement to the contrary notwithstanding, in the event that the amount of the Severance Payments, and any additional compensation, payment or distribution by the Company to or for the benefit of you, whether paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise, calculated in a manner consistent with Section 280G of the Code and the applicable regulations thereunder (the “ Total Severance Payments ”), would be subject to the excise tax imposed by Section 4999 of the Code, the following provisions shall apply:

 

i.

If the Total Severance Payments, reduced by the sum of (1) the Excise Tax and (2) the total of the Federal, state, and local income and employment taxes payable by you on the amount of the Total Severance Payments which are in excess of the Threshold Amount, are greater than or equal to the Threshold Amount, you shall be entitled to the full benefits payable under this Agreement.

 

ii.

If the Threshold Amount is less than (x) the Total Severance Payments, but greater than (y) the Total Severance Payments reduced by the sum of (1) the Excise Tax and (2) the total of the Federal, state, and local income and employment taxes on the amount of the Total Severance Payments which are in excess of the Threshold Amount, then the Total Severance Payments shall be reduced (but not below zero) to the extent necessary so that the sum of all Total Severance Payments shall not exceed the Threshold Amount. In such event, the Total Severance Payments shall be reduced in the following order: (1) cash payments not subject to Section 409A of the Code; (2) cash payments subject to Section 409A of the Code; (3) equity-based payments and acceleration; and (4) non-cash forms of benefits. To the extent any payment is to be made over time (e.g., in installments, etc.), then the payments shall be reduced in reverse chronological order.

For the purposes of this Section 10, “Threshold Amount” shall mean three times the your “base amount” within the meaning of Section 280G(b)(3) of the Code and the regulations promulgated thereunder less one dollar ($1.00); and “Excise Tax” shall mean the excise tax imposed by Section 4999 of the Code, and any interest or penalties incurred by you with respect to such excise tax.

 

 


 

The determination as to which of the alternative provisions of Section 10(a) shall apply to you shall be made by a nationally recognized accounting firm selected by the Company (the Accounting Firm ”), which shall provide detailed supporting calculations both to the Company and you within 15 business days of the termination date, if applicable, or at such earlier time as is reasonably requested by the Company or you. For purposes of determining which of the alternative provisions of Section 10(a) shall apply, you shall be deemed to pay federal income taxes at the highest marginal rate of federal income taxation applicable to individuals for the calendar year in which the determination is to be made, and state and local income taxes at the highest marginal rates of individual taxation in the state and locality of the your residence on the date of termination, net of the maximum reduction in federal income taxes which could be obtained from deduction of such state and local taxes. Any determination by the Accounting Firm shall be binding upon the Company and you.

10.

Litigation and Regulatory Cooperation . During and after your employment, you agree to cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while you were employed by the Company. Your full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after your employment, you also agree to cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while you were employed by the Company. The Company shall reimburse you for any reasonable out-of-pocket expenses incurred in connection with your performance of obligations pursuant to this Section 9.

11.

Relief . If you breach, or propose to breach, any portion of this Agreement, including any of the provisions of the Restrictive Covenant Agreement, or, if applicable, the Release Agreement, the Company shall be entitled, in addition to all other remedies that it may have, to an injunction or other appropriate equitable relief to restrain any such breach, and, if applicable, the Company shall have the right to suspend or terminate payment of the Severance Payments or any other the payments, benefits and or accelerated vesting pursuant to Section 7 of this Agreement. Such suspension or termination shall not limit the Company’s other options with respect to relief for such breach and shall not relieve you of duties under this Agreement, the Restrictive Covenant Agreement, the Equity Documents or the Release Agreement.

12.

Miscellaneous . This Agreement, including the Restrictive Covenant Agreement and the Equity Documents constitute the entire agreement as to your employment relationship with the Company and will supersede any prior agreement or understandings, whether in writing or oral.

 

a.

This Agreement shall remain in effect if you are transferred, promoted, or reassigned to work in functions other than your current functions at the Company. Your obligations under this Agreement shall survive the termination of your employment with the Company regardless of the manner or the reasons for such termination.

 

 


 

 

b.

This Agreement may not be modified or amended unless agreed to in writing by you and an expressly authorized representative of the Company.

 

c.

No waiver of any provision hereof shall be effective unless made in writing and signed by the waiving party. The failure of any party to require the performance of any term or obligation of this Agreement, or the waiver by any party of any breach of this Agreement, shall not prevent any subsequent enforcement of such term or obligation or be deemed a waiver of any subsequent breach.

 

d.

All forms of compensation referred to in this Agreement are subject to reduction to reflect applicable withholding and payroll taxes and other deductions required by law.

 

e.

This Agreement shall inure to the benefit of, and be binding upon, the Company and you, and our respective heirs, legal representatives, successors and assigns. This Agreement may be assigned by the Company without your consent to any successor entity in the event of a merger, acquisition, change of control, or sale of all or substantially all of the business or assets of the Company. “Foundation Medicine” and “Company” shall also mean any such successor entity as the context requires.

 

f.

The resolution of any disputes as to the meaning, effect, performance or validity of this Agreement, the Restrictive Covenant Agreement or arising out of, related to, or in any way connected with your employment with the Company or any other relationship between you and the Company will be governed by the law of the Commonwealth of Massachusetts, excluding laws relating to conflicts or choice of law. Any dispute arising under this Agreement, except those under the Restricted Covenant Agreement, shall be resolved exclusively by arbitration conducted before a single arbitrator in accordance with the Employment Arbitration Rules of the American Arbitration Association in effect at the time such arbitration is conducted. All hearings shall be held in Boston,
Massachusetts. Judgment upon the award rendered by the arbitrator may be entered in any court having jurisdiction thereof. The parties shall bear equally
the costs of arbitration, including the costs of the arbitrator.

 

g.

If any portion or provision of this Agreement shall to any extent be declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable, shall not be affected thereby, and each portion and provision hereof shall be valid and enforceable to the fullest extent permitted by law.

This Agreement may be executed in two counterparts, each of which shall be an original and all of which together shall constitute one and the same instrument.

Michael, we look forward to you joining the Company. If you have further questions or require additional information, please feel free to contact me.

 

 


 

 

Sincerely,

FOUNDATION MEDICINE, INC.

/s/ Sarah Larson__________________

By:      Sarah Larson
Title:   Senior Vice President, Human Resources

 

 

YOU ACKNOWLEDGE THAT YOU HAVE CAREFULLY READ THIS AGREEMENT, INCLUDING EXHIBIT A, AND UNDERSTAND AND AGREE TO ALL OF THE PROVISIONS IN THIS AGREEMENT AND ITS EXHIBITS. FACIMILE AND PDF SIGNATURES SHALL HAVE THE SAME LEGAL EFFECT AS ORIGINALS.

Accepted and agreed by:

/s/ Michael Doherty

Employee Signature

Michael Doherty

Date: December 13, 2016

 

 

 

 


 

EXHIBIT A

Employee Non-Competition, Non-Solicitation, Confidentiality and Assignment Agreement

(See attached)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Non-Competition, Non-Solicitation,
Confidentiality and Assignment Agreement

In consideration and as a condition of my employment or continued employment by Foundation Medicine, Inc. (together with its subsidiaries and affiliates, the “Company”), I hereby agree as follows:

1. Proprietary Information .  I agree that all information, whether or not in writing, whether or not disclosed before or after I was first employed by the Company, concerning the Company’s business, technology, business relationships or financial affairs that the Company has not released to the general public (collectively, “Proprietary Information”), and all tangible embodiments thereof, are and will be the exclusive property of the Company.  By way of illustration, Proprietary Information may include information or material that has not been made generally available to the public, such as: (a) corporate information, including plans, strategies, methods, policies, resolutions, notes, email correspondence, negotiations or litigation; (b) marketing information, including strategies, methods, customer identities or other information about customers, prospect identities or other information about prospects, or market analyses or projections; (c) financial information, including cost and performance data, debt arrangements, equity structure, investors and holdings, purchasing and sales data and price lists; and (d) operational and technological information, including plans, specifications, manuals, forms, templates, software, designs, methods, procedures, formulas, discoveries, inventions, improvements, biological or chemical materials, concepts and ideas; (e) patient information including patient medical records and all other information relating to patients and (f) personnel information, including personnel lists, reporting or organizational structure, resumes, personnel data, compensation structure, performance evaluations and termination arrangements or documents.  Proprietary Information includes, without limitation, (1) information received in confidence by the Company from its customers or suppliers or other third parties, and (2) all biological or chemical materials and other tangible embodiments of the Proprietary Information.

2. No Unauthorized Disclosure or Use .  I will not, at any time, without the Company’s
prior written permission, either during or after my employment, disclose or transfer any Proprietary Information to anyone outside of the Company, or use or permit to be used any Proprietary Information for any purpose other than the performance of my duties as an employee of the Company.  I will cooperate with the Company and use my best efforts to prevent the unauthorized disclosure of all Proprietary Information.  I will deliver to the Company all copies and other tangible embodiments of Proprietary Information in my possession or control upon the earlier of a request by the Company or termination of my employment.

Further, notwithstanding my nondisclosure obligations described in this Section 2, I have been advised that 18 USC Section 1833(b) provides that an individual shall not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that (A) is made: (1) in confidence to a federal, state or local government official, either directly or indirectly, or to an attorney, and (2) solely for the purpose of reporting or investigating a suspected violation of law; or (B) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal.  I have been further advised that an individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of law may disclose the trade secret information in the court proceeding, so long as the individual (i) files any document containing the trade secret under seal; and (ii) does not disclose the trade secret, except pursuant to court order.

 

 


 

3. Rights of Others .  I understand that the Company is n ow and may hereafter be subject to non-disclosure or confidentiality agreements with third persons that require the Company to protect or refrain from use of proprietary information.  I agree to be bound by the terms of such agreements in the event I have access to such proprietary information.

4. Commitment to Company; Avoidance of Conflict of Interest .  While an employee of the Company, I will devote my full business/professional time and attention to the Company’s business.  I also agree that I will not engage in any other business activity (including service on a Board of Directors) that conflicts with either my time commitment to the Company or my duties to the Company (e.g., being employed by, associated with or having a financial interest in a Company customer, vendor, supplier or any entity engaged in business with Company) or otherwise violates the Code of Conduct, unless I receive prior approval in writing from a representative of the Human Resources Department, in consultation with the Legal Department. I will advise the President of the Company or his or her nominee at such time as any activity of either the Company or another business presents me with a conflict of interest or the appearance of a conflict of interest as an employee of the Company.  I will take whatever action is requested of me by the Company to resolve any conflict or appearance of conflict that it finds to exist.

5. Developments .  I hereby do assign and transfer and, to the extent any such assignment cannot be made at present, will assign and transfer, to the Company and its successors and assigns, all my right, title and interest in and to all Developments (as defined below) that: (a) are created, developed, made, conceived or reduced to practice by me (alone or jointly with others) or under my direction (collectively, “conceived”) during the period of my employment and six (6) months thereafter and that relate to the business of the Company or to products, methods or services being researched, developed, manufactured or sold by the Company; (b) result from tasks assigned to me by the Company; or (c) result from the use of premises, Proprietary Information or personal property (whether tangible or intangible) owned, licensed or leased by the Company (collectively, “Company-Related Developments”), and all related patent rights, trademarks, copyrights and other intellectual property rights in all countries and territories worldwide claiming, covering or otherwise arising from or pertaining to Company-Related Developments (collectively, “Intellectual Property Rights”).  I further agree that “Company-Related Developments” include, without limitation, all Developments that (i) were conceived by me before my employment, (ii) relate to the business of the Company or to products, methods or services being researched, developed, manufactured or sold by the Company, and (iii) were not subject to an obligation to assign to another entity when conceived. I will make full and prompt disclosure to the Company of all Company-Related Developments, as well as all other Developments conceived by me during the period of my employment and six (6) months thereafter.  I acknowledge that all work performed by me as an employee of the Company is on a “work for hire” basis.  I hereby waive all claims to any moral rights or other special rights that I may have or accrue in any Company-Related Developments.

“Developments” mean inventions, discoveries, designs, developments, methods, modifications, improvements, processes, biological or chemical materials, algorithms, databases, computer programs, formulae, techniques, trade secrets, graphics or images, audio or visual works, and other works of authorship.

If, in the course of my employment with the Company, I incorporate a Development conceived by me before my employment that are not Company-Related Developments (“Prior Inventions”) into a Company product, process or research or development program or other work done for the Company, I hereby grant to the Company a nonexclusive, royalty-free, fully paid-up, irrevocable, perpetual, worldwide license (with the full right to sublicense through multiple tiers) to make, have

 

 


 

made, modify, use, offer for sale, import and sell such Prior Invention.  Notwithstanding the foregoing, I will not incorporate, or permit to be incorporated, Prior Inventions in any Company-Related Development without the Company’s prior written consent.

I understand that to the extent this Agreement is required to be construed in accordance with the laws of any state which precludes a requirement in an employee agreement to assign certain classes of inventions made by an employee, this Section 5 will be interpreted not to apply to any invention which a court rules and/or the Company agrees falls within such classes.

To preclude any possible uncertainty, I have set forth on Exhibit A attached hereto a complete list of Developments that I have, alone or jointly with others, conceived, developed or reduced to practice prior to the commencement of my employment with the Company that I consider to be my property or the property of third parties and that I wish to have excluded from the scope of this Agreement (“Prior Inventions”).  If disclosure of any such Prior Invention would cause me to violate any prior confidentiality agreement, I understand that I am not to list such Prior Inventions in Exhibit A but am only to disclose a cursory name for each such invention, a listing of the party(ies) to whom it belongs and the fact that full disclosure as to such inventions has not been made for that reason.  I have also listed on Exhibit A all patents and patent applications in which I am named as an inventor, other than those which have been assigned to the Company (“Other Patent Rights”).

6. Documents and Other Materials .  I will keep and maintain adequate and current records of all Proprietary Information and Company-Related Developments conceived by me, which records will be available to and remain the sole property of the Company at all times.  All files, letters, notes, memoranda, reports, records, data, sketches, drawings, notebooks, layouts, charts, quotations and proposals, specification sheets, program listings, blueprints, models, prototypes, materials or other written, photographic or other tangible material containing or embodying Proprietary Information, whether created by me or others, which come into my custody or possession, are the exclusive property of the Company to be used by me only in the performance of my duties for the Company.  At any time upon the request of the Company, and in any event upon the termination of my employment for any reason, I will deliver to the Company all of the foregoing, and all other materials of any nature pertaining to the Proprietary Information of the Company and to my work, and will not take or keep in my possession any of the foregoing or any copies.  Any property situated on the Company’s premises and owned by the Company, including laboratory space, computers, disks and other storage media, filing cabinets or other work areas, is subject to inspection by the Company at any time with or without notice.

7. Enforcement of Intellectual Property Rights .  I will cooperate fully with the Company, both during and after my employment with the Company, with respect to the procurement, maintenance and enforcement of Intellectual Property Rights, as well as all other patent rights, trademarks, copyrights and other intellectual property rights in all countries and territories worldwide owned by or licensed to the Company.  I will sign, both during and after the term of this Agreement, all papers, including copyright applications, patent applications, declarations, oaths, assignments of priority rights, and powers of attorney, which the Company may deem necessary or desirable in order to protect its rights and interests in any Company-Related Development or Intellectual Property Rights.  If the Company is unable, after reasonable effort, to secure my signature on any such papers, I hereby irrevocably designate and appoint each officer of the Company as my agent and attorney-in-fact to execute any such papers on my behalf, and to take any and all actions as the Company may deem necessary or desirable in order to protect its rights and interests in the same.

 

 


 

8. Non-Competition and Non-Solicitation .   I acknowledge and agree that the Company has invested substantial time, money and resources in the development of its Proprietary Information, including as it pertains to its customers, clients, and collaborators.  I further acknowledge that during the course of my employment, I will have access to and may use and work with such Proprietary Information that pertains to the customers, clients, and collaborators of the Company, and I agree that any Proprietary Information associated with any customer, client, or collaborator belongs exclusively to the Company.

In order to protect the Company’s Proprietary Information and good will, during my employment and for a period of one (1) year following the termination of my employment for any reason (the “Restricted Period”) I will not directly or indirectly, whether as owner, partner, shareholder, director, consultant, agent, employee, co-venturer or otherwise, engage, participate or invest in any business activity anywhere in the Restricted Territory (defined below) that develops, manufactures or markets any products, or performs any services, that are otherwise competitive with or similar to the products or services of the Company, or products or services that the Company has under development or that are the subject of active planning at any time during my employment; provided that this will not prohibit any possible investment in publicly traded stock of a company representing less than one percent of the stock of such company.  For purposes of this Agreement, the “Restricted Territory” shall mean each and every country, province, state, city or other political subdivision in which the Company or any of its affiliates carries on or actively plans to carry on any activities of the Company’s business (including, without limitation, sales and marketing activities).

In addition, during my employment and the Restricted Period, I will not, directly or indirectly, in any manner, other than for the benefit of the Company, (a) call upon, solicit, divert or take away any of the customers, business or prospective customers of the Company or any of its suppliers, and/or (b) solicit, entice or attempt to persuade any other employee or consultant of the Company to leave the services of the Company for any reason or otherwise participate in or facilitate the hire, directly or through another entity, of any person who is employed or engaged by the Company or who was employed or engaged by the Company within two (2) months of any attempt to hire such person.

I acknowledge and agree that if I violate any of the provisions of this Section 8, the running of the Restricted Period will be extended by the time during which I engage in such violation(s).

9. Government Contracts .  I acknowledge that the Company may have from time to time agreements with other persons or with the United States Government or its agencies that impose obligations or restrictions on the Company regarding inventions made during the course of work under such agreements or regarding the confidential nature of such work.  I agree to comply with any such obligations or restrictions upon the direction of the Company.  In addition to the rights assigned under Section 5, I also assign to the Company (or any of its nominees) all rights which I have or acquired in any Developments, full title to which is required to be in the United States under any contract between the Company and the United States or any of its agencies.

10. Prior Agreements .  I hereby represent that, except as I have fully disclosed previously in writing to the Company, I am not bound by the terms of any agreement with any previous employer or other party to refrain from using or disclosing any trade secret or confidential or proprietary information in the course of my employment with the Company or to refrain from competing, directly or indirectly, with the business of such previous employer or any other party.  I further represent that my performance of all the terms of this Agreement as an employee of the Company does not and will not breach any agreement to keep in confidence proprietary

 

 


 

information, knowledge or data acquired by me in confidence or in trust prior to my employment with the Company.  I will not disclose to the Company or induce the Company to use any confidential or proprietary information or material belonging to any previous employer or others.

11. Remedies Upon Breach .  I understand that the restrictions contained in this Agreement are necessary for the protection of the business and goodwill of the Company and I consider them to be reasonable for such purpose.  Any breach of this Agreement is likely to cause the Company substantial and irrevocable damage and therefore, in the event of such breach, the Company, in addition to such other remedies that may be available, will be entitled to specific performance and other injunctive relief without the posting of a bond.  If I violate this Agreement, in addition to all other remedies available to the Company at law, in equity, and under contract, I agree that I am obligated to pay all the Company’s costs of enforcement of this Agreement, including attorneys’ fees and expenses.

12. Publications .  I will obtain the Company’s written approval before publishing or submitting for publication any material that relates to my work at the Company and/or incorporates any Proprietary Information.

13. Use of Voice, Image and Likeness .  I give the Company permission to use any and all of my voice, image and likeness, with or without using my name, in connection with the products and/or services of the Company, for the purposes of advertising and promoting such products and/or services and/or the Company, and/or for other purposes deemed appropriate by the Company in its reasonable discretion, except to the extent expressly prohibited by law.

14. No Employment Obligation .  I understand that this Agreement does not create an obligation on the Company or any other person to continue my employment.  I acknowledge that, unless otherwise agreed in a formal written employment agreement signed on behalf of the Company by an authorized officer, my employment with the Company is at will and therefore may be terminated by the Company or me at any time and for any reason.

15. Corporate Compliance .  I agree that I will abide by all policies and procedures that the Company may have in effect from time to time, including without limitation, the Company’s Code of Conduct and corporate compliance program.  I further acknowledge that failure to abide by policies and procedures may result in discipline, including immediate termination of my employment.  Nothing herein limits my at-will employment with the Company, pursuant to Section 14 above.

16. Survival and Assignment by the Company .  I understand that my obligations under this Agreement will continue in accordance with its express terms regardless of any changes in my title, position, duties, salary, compensation or benefits or other terms and conditions of employment.  I further understand that my obligations under this Agreement will continue following the termination of my employment regardless of the manner of such termination and will be binding upon my heirs, executors and administrators.  The Company will have the right to assign this Agreement to its affiliates, successors and assigns for no additional consideration.  I expressly consent to be bound by the provisions of this Agreement for the benefit of the Company or any parent, subsidiary or affiliate to whose employ I may be transferred without the necessity that this Agreement be resigned at the time of such transfer.  I acknowledge that the term “the Company,” as used in this Agreement, shall also mean any such successor entity as the context requires.

 

 


 

17. Disclosure to Future Employers .  I will provide a copy of this Agreement to any prospective employer, partner or co-venturer prior to entering into an employment, partnership or other business relationship with such person or entity.

18. Exit Interview .  If and when I depart from the Company, I may be required to attend an exit interview and sign an “Employee Exit Acknowledgement” to reaffirm my acceptance and acknowledgement of the obligations set forth in this Agreement.  During the Restricted Period following termination of my employment, I will notify the Company of any change in my address and of each subsequent employment or business activity, including the name and address of my employer or other post-Company employment plans and the nature of my activities.

19. Severability .  In case any provisions (or portions thereof) contained in this Agreement will, for any reason, be held invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability will not affect the other provisions of this Agreement, and this Agreement will be construed as if such invalid, illegal or unenforceable provision had never been contained herein.  If, moreover, any one or more of the provisions contained in this Agreement will for any reason be held to be excessively broad as to duration, geographical scope, activity or subject, it will be construed by limiting and reducing it, so as to be enforceable to the extent compatible with the applicable law as it will then appear.

20. Protected Disclosures .  I understand that nothing contained in this Agreement limits my ability to communicate with any federal, state or local governmental agency or commission, including to provide documents or other information, without notice to the Company.  I also understand that nothing in this Agreement limits my ability to share compensation information concerning myself or others, except that this does not permit me to disclose compensation information concerning others that I obtain because my job responsibilities require or allow access to such information.

21. Entire Agreement .  This Agreement constitutes the entire and only agreement between the Company and me respecting the subject matter hereof, and supersedes all prior agreements and understandings, oral or written, between us concerning such subject matter; provided, however, that this Agreement shall supplement, and shall not limit or be limited by, any other agreement I have with, or obligation I have to, the Company regarding noncompetition, nonsolicitation, confidentiality, assignment of inventions, and related covenants.  No modification, amendment, waiver or termination of this Agreement or of any provision hereof will be binding unless made in writing and signed by an authorized officer of the Company.  Failure of the Company to insist upon strict compliance with any of the terms, covenants or conditions hereof will not be deemed a waiver of such terms, covenants or conditions.  In the event of any inconsistency between this Agreement and any other contract between the Company and me, the provisions of this Agreement will prevail.

22. Interpretation, Governing Law, Forum Selection Clause .  This Agreement and any claims arising out of this Agreement (or any other claims arising out of the relationship between the parties) shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts and shall in all respects be interpreted, enforced and governed under the internal and domestic laws of such state, without giving effect to the principles of conflicts of laws of such state.  Any claims or legal actions by one party against the other shall be commenced and maintained in any state or federal court located in the Commonwealth of Massachusetts, and I hereby submit to the jurisdiction and venue of any such court.  As used in this Agreement, “including” means “including but not limited to.”

 

 


 

23. Execution of Agreement .  This Agreement shall be binding and effective upon the undersigned’s signature.

BY SIGNING BELOW, I CERTIFY THAT I HAVE READ THIS AGREEMENT CAREFULLY AND AM SATISFIED THAT I UNDERSTAND IT COMPLETELY.

IN WITNESS WHEREOF, the undersigned has executed this agreement as a sealed
instrument as of the date set forth below.

 

Signed:

 

/s/ Michael Doherty

 

 

(Employee’s full name)

 

Type or print name: Michael Doherty

Date: January 2, 2017

 

 

 

 


 

EXHIBIT A

TO: Foundation Medicine, Inc.

FROM:

DATE:

SUBJECT: Prior Inventions

The following is a complete list of all inventions or improvements relevant to the subject matter of my employment by the Company that have been made or conceived or first reduced to practice by me alone or jointly with others prior to my engagement by the Company:

 

No inventions or improvements

 

See below:

 

 

 

 

 

 

 

 

 

 

 

Additional sheets attached

The following is a list of all patents, patent applications and other patent rights that I have invented:

 

None

 

See below:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

April 30, 2018

 

Michael Doherty

437 D Street
Apartment 7F
Boston, MA 02110

 

Re:  Acknowledgement Regarding Section 2(e) of the Offer Letter

 

Dear Michael:

 

The purpose of this letter agreement is to confirm the arrangement on March 31, 2018 between you and Foundation Medicine, Inc. (“FMI” or the “Company”) regarding the modification of section 2(e) of your December 5, 2016 offer letter from the Company (the “Offer Letter”).

 

Specifically, in exchange for a payment to you on March 31, 2018 in the gross amount of Fifty Thousand Dollars ($50,000), you have agreed that (i) the Company has fulfilled all of its obligations to you under section 2(e) of the Offer Letter; (ii) you are not eligible for or entitled to any further payments under section 2(e) of the Offer Letter effective March 31, 2018.

 

Please acknowledge that the declarations in this letter are true and correct by signing below on or before May 1, 2018.

Sincerely,

 

/s/ Susan Miele

Susan Miele

Head of Human Resources

 

Accepted and agreed by:

/s/ Michael Doherty April 30, 2018
Michael Doherty

 

 

 

Exhibit 10.3

150 Second Street, 1st Floor

Cambridge Massachusetts 02141

 

TEL 617.418.2200

FAX 617.418.2201

May 1, 2018

 

Konstantin Fiedler

 

Re: Employment with FMI Germany GmbH and Foundation Medicine, Inc.

 

Dear Konstantin:

As you are aware, you are currently employed as the Managing Director of FMI Germany GmbH, a German corporation (“FMI Germany”) that is a wholly owned subsidiary of Foundation Medicine, Inc., a Delaware corporation (the “Company” or “Foundation Medicine”), pursuant to a Service Agreement between you and FMI Germany, dated January 1, 2017 but which commenced November 1, 2016 (the “Service Agreement”).  

In connection with your promotion to Chief Operating Officer of the Company, effective February 16, 2018 (the “Start Date”), this letter agreement (this “Agreement”) confirms the terms and conditions of your employment (i) commencing on the Start Date and continuing through the earlier of the date we mutually agree that you have established residency in the United States or August 31, 2018 (the “Transition Period”), and (ii) commencing on the day following the last date of the Transition Period and continuing thereafter (“U.S. Employment Period”), unless employment during the U.S. Employment Period cannot be commenced due to total disability in which case the Service Agreement shall not terminate.  

Transition Period

During the Transition Period, you shall remain an employee of FMI Germany under the terms and conditions of the Service Agreement, attached to this Agreement at Exhibit A, provided that effective on the Start Date, the terms of the Service Agreement shall be deemed modified or supplemented, as the case may be, as follows:

 

1.

Title and Reporting . In addition to acting as the Managing Director of FMI Germany, you will assume the position of Chief Operating Officer of the Company, reporting to Troy Cox, the President and Chief Executive Officer of the Company.

 

 

2.

Base Salary . Your base rate of pay under §4 of the Service Agreement shall be increased from €250,000 to €312,000, and will continue to be paid by FMI Germany on a salaried basis (the "Base Salary"). The Base Salary will be paid in accordance with FMI Germany’s standard payroll practices and subject to withholdings as required by applicable law.

 


 

3.

Performance Incentive Pay ment. Your target bonus under §4(2) of the Service Agreement shall increase from 35% of your base salary to 40%. The annual bonus is dependent on the achievement of goals to be determined at the beginning of each calendar year. Y ou must be employed by the Company at the time annual performance incentive program payments are distributed to similarly situated employees to be eligible for any payments under the program.

 

 

4.

Living Expense Assistance .  As condition of your new position, you are expected to relocate to the Cambridge, Massachusetts metropolitan area within the Transition Period. During the Transition Period, you are eligible for a living expense allowance up to €28,514.40 (or US$35,000) (the “Living Expense Allowance”) to be paid on your behalf towards temporary corporate housing or in the form of reimbursement for customary living expenses and food expenses (to the extent such food expenses are not otherwise reimbursable as a business expense) and not as an addition to your salary, in each instance as incurred in connection with your temporary residence in the Cambridge, Massachusetts metropolitan area and subject to substantiation in accordance with the Company’s business travel and expense reimbursement policy. If you are terminated for Cause or if you resign without Good Reason, in each instance within 24 months after your Start Date, you will reimburse the Company for the entirety of the amount of the Living Expenses paid to you within thirty (30) days of your last day of employment. The Company will determine in its reasonable judgement what, if any, of your Living Expenses paid for or reimbursed by the Company are taxable to you in accordance with applicable law and will comply with associated withholding and tax reporting obligations. To the extent that certain of these Living Expenses and Relocation Expenses are deemed to be taxable income, you will receive a tax gross-up payment such that after payment of any applicable taxes on such amount, there remains a balance sufficient to pay the taxes incurred. The Company will make the tax gross-up payment under this section promptly but in no event later than the end of the calendar year in which you remit the related taxes.

 

 

5.

Termination of Employment .  The terms and conditions described below under Section E “Termination of Employment” and Section F “Definitions” shall apply during the Transition Period, and all rights, benefits and obligations established thereunder shall supercede §3(2) – (3) of the Service Agreement.

 

U.S. Employment Period

As of the first day of U.S. Employment Period, you and the Company agree the Service Agreement shall terminate, you shall resign as an employee and at the Company’s request, as a Managing Director of FMI Germany, and you shall become an employee of the Company under the terms and conditions of this Agreement (the “U.S. Effective Date”).  As of the U.S. Effective Date, the terms of the Non-Competition, Non-Solicitation, Confidentiality and Assignments Agreement (the "Restrictive Covenant Agreement") attached as Exhibit B to this Agreement shall become effective, and the terms of your employment with the Company shall be as follows:

 

A.

Title and Reporting . You will continue to hold the position of Chief Operating Officer of the Company, reporting to Troy Cox, the President and Chief Executive Officer of the Company.


 

B.

Compensation and Related Matters

 

a.

Base Salary . You will continue to be paid on a salaried exempt basis at a rate of $14,844.42 per bi-weekly pay period, equivalent to an annualized base salary of $385,955, which represents payment for all hours worked by you for the Company (the "Base Salary"). The Base Salary will be paid in accordance with Foundation Medicine's standard payroll practices and subject to deductions and withholdings as required by applicable federal and state law.

 

b.

Performance Incentive Payment. You shall continue to be eligible to participate in the Company's annual performance incentive program, subject to its terms and conditions and at the discretion of the Company's Board of Directors (the "Board"), with the potential to earn incentive compensation equivalent to a target of up to 40% of your annual Base Salary ("Annual Performance Incentive Target"). The performance incentive is based upon the achievement of several performance objectives, including Company and individual performance objectives. The Company may adjust the annual performance incentive program and the Annual Performance Incentive Target in its discretion. Except in connection with the payment to you of Severance Payments (as defined below), you must be employed by the Company at the time annual performance incentive program payments are distributed to similarly situated employees to be eligible for any payments under the program.

 

c.

Expenses .  The Company will reimburse your reasonable out-of-pocket travel and business expenses and other expenses related to your work in accordance with the Company's business travel and expense reimbursement policy.

 

d.

Restricted Stock Units .  On April 1, 2018, the Company’s Board of Directors approved an equity award of Restricted Stock Units ("RSUs") with an aggregate value of $800,000 (the "Equity Award") based on the 30-day average closing trading price of Foundation Medicine common stock made within five days of the date of the award date, or $78.74 through March 27, 2018.  The RSUs issued under the Equity Award will vest over a three-year period as follows: 8.3% will vest on the first day of each calendar quarter following the Equity Grant Date until 100% of the RSUs have vested. As a condition to receiving each portion of the RSUs vesting under the Equity Award, you must be an employee of the Company as of the applicable vesting date without any prior interruption of service. The Equity Award will be governed by a restricted stock unit award agreement in the standard form approved by Foundation Medicine's Board and shareholders, and will be subject to the provisions of Foundation Medicine's then-current stock incentive plan (together with any other incentive equity plan(s), as may be amended from time to time, any associated award agreements, the "Equity Documents").

 

e.

Relocation Expense Assistance .  If, and conditional upon, your relocation to the Cambridge, Massachusetts metropolitan area prior to the end of the Transition Period, the Company will reimburse you for reasonable documented relocation expenses incurred by you up to $90,000 (the “Relocation Expenses”), including the costs or expenses incurred by you in connection with searching for a residence and thereafter relocating your family and your possessions from Germany in accordance with the

 


 

Company’s relocation policy.  Relocation Expenses may include customary closing costs, but not financing costs, related to the purchase of your new residence in the area.   If you are terminated for Cause or if you resign without Good Reason, in each instance within 24 months after your Start Date, you will reimburse the Company for the entirety of the amount of the Relocation Expenses paid to you within thirty (30) days of your last day of employment. The Company will determine in its reasonable judgement what, if any, of your Living Expenses or Relocation Expenses paid for or reimbursed by the Company are taxable to you in accordance with applicable law and will comply with associated withholding and tax reporting obligations. To the extent that certain of these Living Expenses and Relocation Expenses are deemed taxable by the IRS in a given year, the Company will provide you with a tax gross-up payment such that after payment of any federal, state, and employment taxes on such amount, there remains a balance sufficient to pay the applicable taxes. The Company will make the tax gross-up payment under this section promptly but in no event later than the end of the calendar year in which you remit the related taxes.

 

 

f.

Tuition Reimbursement .  The Company agrees to provide you with reimbursement for private school tuition payments for your children of up to $45,000 per year in the aggregate for two years (the “Tuition Reimbursement Payments”).   To the extent that the Tuition Reimbursement Payments are deemed taxable by the IRS in any given year, the Company will provide you with a tax gross-up payment such that after payment of any federal, state, and employment taxes on such amount, there remains a balance sufficient to pay the applicable taxes. The Company will make the tax gross-up payment promptly but in no event later than the end of the calendar year in which you remit the related taxes.

 

g.

Pension Contribution .  The Company agrees to provide you with an annual payment of $25,000 per year beginning in 2018, which may be applied to a private pension plan in Germany. Under the US-Germany Tax Treaty, the pension contributions may not be subject to taxation under United States law, however to the extent that the annual pension contributions are deemed taxable under the tax laws of the United States in any given year, the Company will provide you with a tax gross-up payment at the end of the calendar year in which you remit the related taxes.

 

h.

Other Benefits . As a regular, full-time United States-based employee, you will be eligible to participate in the employee benefit programs that Foundation Medicine offers to its employees in comparable positions, which currently include health, dental and vision insurance, a 401(k) Plan with an employer matching contribution, and paid Company holidays and sick time, in each case subject to plan terms and/or generally applicable Foundation Medicine policies.  In addition, the Company will provide you with life insurance coverage in the amount of $500,000 and $1,000,000 in the event of accidental death. You are entitled to accrue up to thirty (30) working days of paid vacation each calendar year. W here a particular Company benefit is subject to a formal plan (for example, health insurance or 401(k) plan participation), eligibility to participate in and receive any particular benefit is governed solely by the applicable plan document .


 

C.

At-Will Employ ment . Your employment at all times shall remain "at will," meaning that either you or the Company may terminate the employment relationship at any time, for any lawful reason, with or without Cause.

 

D.

Non-Competition, Non-Solicitation, Confidentiality and Assignment Agreement .  As part of your employment with Foundation Medicine, you are exposed to, and provided with, valuable confidential and/or trade secret information concerning Foundation Medicine and its present and future business plans and operations.  As a result, in order to protect Foundation Medicine’s substantial investment of time and money in the creation and maintaining of its confidential information and good-will with its customers, clients, and collaborators, this Agreement is contingent upon your signing the Restrictive Covenant Agreement and your continued willingness to abide by its terms.  By signing below, you represent that you are not subject to any agreements which might restrict your conduct at the Company, and that you understand that if you become aware at any time during your employment with the Company that you are subject to any agreements which might restrict your activities at Foundation Medicine, you are required to immediately inform the Company of the existence of such agreements.  In the event of an irresolvable conflict, your employment by Foundation Medicine could be subject to termination and such termination would be deemed a for “Cause” termination for purposes of this Agreement and the Equity Documents.

 

E.

Termination of Employment.

 

a.

Severance Payments . Without otherwise limiting the "at will" nature of your employment if: (i) your employment is terminated by the Company without Cause at any time, or (ii) within eighteen (18) months following a Change in Control you terminate your employment with the Company for Good Reason in accordance with the Good Reason Process, and, in either event, you enter into, do not revoke, and comply with a Release, the Company shall pay or provide you with: (a) Salary Continuation for twelve (12) months following your termination date (the "Salary Continuation Period") and (b) Health Care Continuation during the Salary Continuation Period (collectively, the "Severance Payments"); provided and notwithstanding the foregoing, if your employment is terminated in connection with a Change in Control and you immediately become reemployed by any direct or indirect successor to the business or assets of the Company, the termination of your employment upon the Change in Control shall not be considered a termination without Cause for purposes of this Agreement.

 

b.

Equity Acceleration . In the event that you become entitled to Severance Payments at any time within eighteen (18) months following a Change in Control, and you enter into, do not revoke, and comply with a Release, then all outstanding unvested equity-based compensation awards that have been granted acceleration rights and were granted to you under the Equity Documents prior to the Change in Control shall become exercisable and vested in full, and all restrictions thereon shall lapse, notwithstanding any vesting schedule or other provisions to the contrary in the agreements evidencing such awards or in the underlying equity plan, and the Company and you hereby agree that any agreements covering such awards are hereby, and will be deemed to be, amended to give effect to this provision.


 

c.

Non-Eligibility for Severance Payments or Equit y Award Acceleration . For the avoidance of doubt, you and the Company acknowledge that if your employment is terminated: (i) by the Company for Cause, (ii) by you without Good Reason or with Good Reason absent a Change in Control, (iii) by you with Good Reason following a Change in Control but without complying with the Good Reason Process, or (iv) as a result of your death or disability, then, as a result of such termination, (w) you shall not be entitled to Severance Payments, (x) you shall be entitled to receive only Base Salary earned plus accrued but unused vacation pay through the date of termination, (y) the unvested portion of your Equity Awards will not accelerate, and (z) your Equity Awards shall expire or be forfeited in accordance with the terms of the Equity Documents.

 

F.

Definitions . For purposes of this Agreement, the following terms shall have the following meanings:

"Company" means Foundation Medicine, Inc., and its successors and assigns.

"Cause" means one or more of the following events: (i) your conviction of, or the entry of a pleading of guilty or nolo contendere to, any crime involving (A) fraud or embezzlement, or (B) any felony; (ii) your willful failure to perform (other than by reason of disability), or gross negligence in the performance of, your duties and responsibilities; (iii) your failure to comply with the requirements of the Company’s Code of Conduct or any other Company policy or practice(s) regarding acceptable workplace conduct; (iv) a material breach by you of any provision of this Agreement, the Restrictive Covenant Agreement, or any of the other agreements you have with the Company, which breach continues or remains uncured after thirty (30) days' notice setting forth in reasonable detail the nature of such breach; or (iv) material fraudulent conduct by you with respect to the Company.

"Change in Control" shall mean any of the following:

a. any "person," as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the "Act") (other than the Company, any of its subsidiaries, or any trustee, fiduciary or other person or entity holding securities under any employee benefit plan or trust of the Company or any of its subsidiaries), together with all "affiliates" and "associates" (as such terms are defined in Rule 12b-2 under the Act) of such person, shall become the "beneficial owner" (as such term is defined in Rule 13d-3 under the Act), directly or indirectly, of securities of the Company representing fifty percent (50%) or more of the combined voting power of the Company's then outstanding securities having the right to vote in an election of the Board ("Voting Securities") (in such case other than as a result of an acquisition of securities directly from the Company); or

b. the date when a majority of the members of the Board of Directors of the Company is replaced by individuals who, prior to their election, or nomination for election by the Company's shareholders, were not approved by a majority of the members of the Board of Directors in existence on the date immediately prior to such election, appointment or nomination (excluding any individuals nominated by any member of the Investor Group (as defined in that certain Investor Rights Agreement, dated as of January 11, 2015 (as amended from time to time), by and among the Company, Roche Holdings, Inc. and certain other stockholders of the Company named therein (the "Investor Rights Agreement") following the occurrence of a Material Breach (as defined in the Investor Rights Agreement)); or


c. the consummation of (A) any consolidation or merger of the Company where the stockholders of the Company, immediately prior to the consolidation or merger, would not, immediately after the consolidation or merger, beneficially own (as such term is defined in Rule 13d-3 under the Act), directly or indirectly, shares representing in the aggregate more than fifty percent (50%) of the voting shares of the Company issuing cash or securities in the consolidation or merger (or of its ultimate parent corporation, if any), or (B) any sale or other transfer (in one transaction or a series of transactions contemplated or arranged by any party as a single plan) of all or substantially all of the assets of the Company; or

d. the consummation by any member of the Investor Group of any tender or exchange offer, merger, consolidation, business combination or other similar transaction involving the Company that results in the Investor Group collectively owning all of the outstanding Voting Securities of the Company.

Notwithstanding the foregoing, a "Change in Control" shall not be deemed to have occurred for purposes of the foregoing clause (a), (i) solely as the result of an acquisition of securities by the Company which, by reducing the number of shares of Voting Securities outstanding, increases the proportionate number of Voting Securities beneficially owned by any person to fifty percent (50%) or more of the combined voting power of all of the then outstanding Voting Securities; provided, however, that if any person referred to in this sentence shall thereafter become the beneficial owner of any additional shares of Voting Securities (other than pursuant to a stock split, stock dividend, or similar transaction or as a result of an acquisition of securities directly from the Company) and immediately thereafter beneficially owns fifty percent (50%) or more of the combined voting power of all of the then outstanding Voting Securities, then a "Change in Control" shall be deemed to have occurred for purposes of the foregoing clause (a); or (ii) as a result of Roche's acquisition of Voting Securities as provided under Section 4.03(a) and/or 4.04(b) of the Investor Rights Agreement.

"Equity Award" means all incentive stock options, non-statutory stock options, shares of restricted stock, restricted stock units or other incentive equity awards in respect of shares of the Company's equity securities that have been or will be granted to you by the Company.

"Good Reason" means that you have complied with the "Good Reason Process" (defined below) following the occurrence of any one or more of the following events or circumstances within twelve (12) months following a Change in Control:

 

(i)

a change in title, responsibility, or authority to a position less than executive level (with such change measured by reference to your title within your business unit post-Change in Control, and not necessarily the applicable company as a whole);

 

 

(ii)

a reduction in your Base Salary of at least 10%;

 

 

(iii)

your principal work location is moved to a new principal location more than fifty (50) miles from the location at which you were principally working as of the effective date of the Change in Control; or

 

 

(iv)

the material breach of this Agreement by the Company or any of the agreements you have with the Company relating to Equity Awards or equity of the Company, which breach constitutes or remains uncured after thirty (30) days' notice setting forth in reasonable detail the nature of such breach.

 


Good Reason Process ” means that (a) you reasonably determine that a Good Reason condition has occurred within eighteen (1 8 ) months following a Change in Control, (b) you notify the Company in writing of the first occurrence of the Good Reason condition within sixty (60) days of the first occurrence of such condition, (c) provided that the Company acknowledges your notification of Good Reason within ten (10) days of receiving such notice and indicates within such time its intention to cure the identified Good Reason condition within thirty (30) days (the “Cure Period”), you agree to cooperate in good faith with the Company’s efforts for a period of up to thirty (30) days following such notice,  (d) notwithstanding such efforts to cure, if any, a material element of at least one Good Reason condition continues to exist, and (e) you terminate your employment within sixty (60) days after the end of the Cure Period or, if the Company failed to indicate its intention to cure the Good Reason condition, the last day of the Company’s ten (10) day notice period.  If the Company fully cures the Good Reason condition during the Cure Period, Good Reason shall be deemed not to have occurred.  The Company’s success at curing a Good Reason condition shall not bar or preclude your right to notify the Company of an occurrence within eighteen (18) months following a Change in Control of another Good Reason condition and to proceed with the Good Reason Process.

"Health Care Continuation" means that if you are participating in the Company's group health plans immediately prior to the date of your termination, then subject to your timely election and eligibility for benefits under the federal COBRA law, and any law that is the successor to COBRA, the Company shall continue to pay the employer portion of your health benefits until the earlier of the end of the Salary Continuation Period and the date you become re-employed or otherwise ineligible for COBRA.

"Release" shall mean a separation agreement in a form prescribed by the Company that includes, without limitation, (i) a general release of claims and non-disparagement covenant, both in favor of the Company and related persons and entities, (ii) reaffirmation of your obligations under the Restrictive Covenant Agreement, the terms of which will be incorporated by reference into the Release, and (iii) a provision stating that, if you breach any of the material provisions of Release, in addition to all other rights and remedies, the Company shall have the right to receive reimbursement for, or to terminate or cease payment of, Severance Payments paid or payable to you.

"Salary Continuation" means that the Company shall continue to pay during the Salary

Continuation Period (a) the sum of your (i) annual base salary rate in effect on your last day of employment and (ii) the target short term incentive bonus amount for the calendar year in which your separation is effective (b) divided by twelve (12). The first payment of Salary Continuation shall be paid within sixty (60) days after the date of termination and shall be made in regular installments on the Company's regular payroll dates; provided, however, that if the sixty (60) day period begins in one calendar year and ends in a second calendar year, the first payment of Salary Continuation shall be paid in the second calendar year.

 

 

G.

Section 409A Compliance . To the extent that any Severance Payments or other benefits to you constitute "non-qualified deferred compensation" under Section 409A of the Internal Revenue Code of 1986 (as amended or replaced) (the "Code"), then such Severance Payments or benefits shall begin only upon or after the date of your "separation from service" (within the meaning of Section 409A of the Code), which may occur on or after the date of the termination of your employment. Neither the Company nor you shall have the right to accelerate or defer the delivery of any such payments except to the extent specifically permitted or required by Section 409A. Anything to the contrary notwithstanding, if at the time of your separation from service

 


 

within the meaning of Section 409A of the Code, the Company determines that you are a "specified employee" within the meaning of Section 409A(a)(2)(B)(i) of the Code, then to the extent any payment or benefit that you become entitled to under this Agreement on account of your separation from service would be considered deferred compensation otherwise subject to the twenty percent (20%) additional tax imposed pursuant to Section 409A(a) of the Code as a result of the application of Section 409A(a)(2)(B)(i) of the Code, such payment shall not be payable and such benefit shall not be provided until the date that is the earlier of (i) six (6) months and one day after your separation from service, or (ii) the your death. If any such delayed cash payment is otherwise payable on an installment basis, the first payment shall include a catch-up payment covering amounts that would otherwise have been paid during the six (6)-month period but for the application of this provision, and the balance of the installments shall be payable in accordance with their original schedule. The determination of whether and when your "separation from service" from the Company has occurred shall be made in a manner consistent with, and based on the presumptions set forth in, Treasury Regulation Section 1.409A-l(h). Solely for purposes of this Section, "Company" shall include all persons with whom the Company would be considered a single employer under Sections 414(b) and 414(c) of the Code.

 

 

All in-kind benefits provided and expenses eligible for reimbursement under this Agreement shall be provided by the Company or incurred by you during the time periods set forth in this Agreement. All reimbursements shall be paid as soon as administratively practicable, but in no event, shall any reimbursement be paid after the last day of the taxable year following the taxable year in which the expense was incurred. The amount of in-kind benefits provided or reimbursable expenses incurred in one taxable year shall not affect the in-kind benefits to be provided or the expenses eligible for reimbursement in any other taxable year (except for any lifetime or other aggregate limitation applicable to medical expenses). Such right to reimbursement or in-kind benefits is not subject to liquidation or exchange for another benefit.

 

The parties intend that this Agreement will be administered in accordance with Section 409A. To the extent that any provision of this Agreement is ambiguous as to its compliance with Section 409A, the provision shall be read in such a manner so that all payments hereunder comply with Section 409A. Each payment pursuant to this Agreement is intended to constitute a separate payment for purposes of Treasury Regulation Section 1.409A-2(b)(2). The parties agree that this Agreement may be amended, as reasonably requested by either party, and as may be necessary to fully comply with Section 409A and all related rules and regulations in order to preserve the payments and benefits provided hereunder without additional cost to either party. The Company shall have no liability to you or to any other person if any provisions of this Agreement that are intended to be exempt from or compliant with Section 409A are not so exempt or compliant.

 


 

H.

Section 280G Limitation .

 

a. Anything in this Agreement to the contrary notwithstanding, in the event that the amount of the Severance Payments, and any additional compensation, payment or distribution by the Company to or for the benefit of you, whether paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise, calculated in a manner consistent with Section 280G of the Code and the applicable regulations thereunder (the "Total Severance Payments"), would be subject to the excise tax imposed by Section 4999 of the Code, the following provisions shall apply:

i. If the Total Severance Payments, reduced by the sum of (1) the Excise Tax and (2) the total of the Federal, state, and local income and employment taxes payable by you on the amount of the Total Severance Payments which are in excess of the Threshold Amount, are greater than or equal to the Threshold Amount, you shall be entitled to the full benefits payable under this Agreement.

ii. If the Threshold Amount is less than (x) the Total Severance Payments, but greater than (y) the Total Severance Payments reduced by the sum of (1) the Excise Tax and (2) the total of the Federal, state, and local income and employment taxes on the amount of the Total Severance Payments which are in excess of the Threshold Amount, then the Total Severance Payments shall be reduced (but not below zero) to the extent necessary so that the sum of all Total Severance Payments shall not exceed the Threshold Amount. In such event, the Total Severance Payments shall be reduced in the following order: (1) cash payments not subject to Section 409A of the Code; (2) cash payments subject to Section 409A of the Code; (3) equity-based payments and acceleration; and (4) non-cash forms of benefits. To the extent any payment is to be made over time (e.g., in installments, etc.), then the payments shall be reduced in reverse chronological order.

b. For the purposes of this Section 10, "Threshold Amount" shall mean three times the your "base amount" within the meaning of Section 280G(b)(3) of the Code and the regulations promulgated thereunder less one dollar ($1.00); and "Excise Tax" shall mean the excise tax imposed by Section 4999 of the Code, and any interest or penalties incurred by you with respect to such excise tax.

c. The determination as to which of the alternative provisions of Section 10(a) shall apply to you shall be made by a nationally recognized accounting firm selected by the Company (the "Accounting Firm"), which shall provide detailed supporting calculations both to the Company and you within 15 business days of the termination date, if applicable, or at such earlier time as is reasonably requested by the Company or you. For purposes of determining which of the alternative provisions of Section IO(a) shall apply, you shall be deemed to pay federal income taxes at the highest marginal rate of federal income taxation applicable to individuals for the calendar year in which the determination is to be made, and state and local income taxes at the highest marginal rates of individual taxation in the state and locality of the your residence on the date of termination, net of the maximum reduction in federal income taxes which could be obtained from deduction of such state and local taxes. Any determination by the Accounting Firm shall be binding upon the Company and you.


 

I.

Relief . If you breach, or propose to breach, any portion of this Agreement, including any of the provisions of the Restrictive Covenant Agreement, or, if applicable, the Release Agreement, the Company shall be entitled, in addition to all other remedies that it may have, to an injunction or other appropriate equitable relief to restrain any such breach, and, if applicable, the Company shall have the right to suspend or terminate payment of the Severance Payments or any other payments, benefits and or accelerated vesting pursuant to this Agreement. Such suspension or termination shall not limit the Company's other options with respect to relief for such breach and shall not relieve you of duties under this Agreement, the Restrictive Covenant Agreement, the Equity Documents, or the Release Agreement.

 

Terms Applicable During Both the Transition Period and the U.S. Employment Period

Unless otherwise specified below, the following terms and conditions shall apply during both the Transition Period and the U.S. Employment Period, unless contrary to the German or United States (including the relevant federal, state, or local law) applicable during each respective period:

a. This Agreement (together with Exhibit A during the Transition Period and Exhibit B during the U.S. Employment Period) and the Equity Documents, constitute the entire agreement as to your employment relationship with the Company and will supersede any prior agreements or understandings, whether in writing or oral.

b. During and after your employment, you agree to cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while you were employed by the Company. Your full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times. During and after your employment, you also agree to cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while you were employed by the Company. The Company shall reimburse you for any reasonable out-of-pocket expenses incurred in connection with your performance of obligations pursuant to this section.

c. Your obligations under this Agreement shall remain in effect if you are transferred, promoted, or reassigned to work in functions at the Company other than in the role of Chief Operating Officer at the Company. Your obligations under this Agreement shall survive the termination of your employment with the Company regardless of the manner or the reasons for such termination.

d. This Agreement may not be modified or amended unless agreed to in writing by you and an expressly authorized representative of the Company.

e. No waiver of any provision of this Agreement shall be effective unless made in writing and signed by the waiving party. The failure of any party to require the performance of any term or obligation of this Agreement, or the waiver by any party of any breach of this Agreement, shall not prevent any subsequent enforcement of such term or obligation or be deemed a waiver of any subsequent breach.


f. All forms of compensation referred to in this Agreement are subject to reduction to ref lect valid withholding, taxes and other deductions required by applicable law.

g. This Agreement shall inure to the benefit of, and be binding upon, the Company and you, and our respective heirs, legal representatives, successors and assigns. This Agreement may be assigned by the Company without your consent to any successor entity in the event of a merger, acquisition, change of control, or sale of all or substantially all of the business or assets of the Company. "Foundation Medicine,” “FMI Germany” and "Company" shall also mean any such successor entity as the context requires.

h. The resolution of any disputes as to the meaning, effect, performance or validity of this Agreement arising out of, related to, or in any way connected with your employment with the Company or any other relationship between you and the Company during the Transition Period will be governed by German law. Notwithstanding the foregoing, if the terms and conditions of this paragraph conflict with any terms of the Service Agreement during the Transition Period, the terms of Service Agreement shall control.

i. The resolution of any disputes as to the meaning, effect, performance or validity of this Agreement, the Restrictive Covenant Agreement or arising out of, related to, or in any way connected with your employment with the Company or any other relationship between you and the Company will be governed during the U.S. Employment Period by the law of the Commonwealth of Massachusetts, excluding laws relating to conflicts or choice of law. Any dispute arising under this Agreement regarding or with respect to the U.S. Employment Period, except those regarding the Restrictive Covenant Agreement, shall be resolved exclusively by arbitration conducted a single arbitrator in accordance with the Employment Arbitration Rules of the American Arbitration Association in effect at the time such arbitration is conducted. All hearings shall be held in Boston, Massachusetts. Judgment upon the award rendered by the arbitrator may be entered in any court having jurisdiction. The parties shall bear equally the costs of arbitration, including the costs of the arbitrator.  

j. If any portion or provision of this Agreement shall to any extent be declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable, shall not be affected, and each portion and provision shall be valid and enforceable to the fullest extent permitted by law.

k. This Agreement may be executed in two counterparts, each of which shall be an original and all of which together shall constitute one and the same instrument. PDF signatures shall have the same legal effect as originals.

Please indicate your acceptance of these terms by signing below.

 

Sincerely,

 

 

 

/s/ Susan Miele

 

Susan Miele

 

Head of Human Resources

 

 

Accepted and agreed by:

 

 

 

 

 

/s/ Konstantin Fiedler

 

May 1, 2018

Konstantin Fiedler

 

 

 

 


 

EXHIBIT A

Service Agreement Between Konstantin Fiedler and FMI Germany GmbH

(See attached)


 

 


 

 

Dienstvertrag

Service Agreement

 

zwischen

between


FMI Germany GmbH

Maximilianstr. 54

80538 München

Deutschland / Germany

 

- nachfolgend " Gesellschaft " -

- hereinafter " Company " -

 

 

und

and

 

Konstantin Fiedler

 

- nachfolgend " Geschäftsführer " -

- hereinafter " Managing Director " -

 

 

- gemeinsam nachfolgend die " Parteien " -

- hereinafter collectively the " Parties " -

 

 

PRÄAMBEL

PREAMBLE

 

Der Geschäftsführer soll zum Geschäftsführer der Gesellschaft bestellt worden.

The Managing Director shall be appointed as managing director of the Company.

 

Die Parteien wollen mit diesem Dienstvertrag die Anstellungsbedingungen des Geschäftsführers mit Wirkung zum 1. Januar 2017, ggf. auch früher, regeln.

With this Service Agreement the Parties wish to regulate the terms and conditions of their service relationship with effect as of 1 January 2017 or sooner, if possible.

 

Dies vorausgeschickt, vereinbaren die Parteien Folgendes:

Having said this, the Parties agree as follows:

 

 

§ 1POSITION / DIENSTSITZ

§ 1 position / pLACE OF wORK

 

(1) Der Geschäftsführer ist, gegebenenfalls zusammen mit weiteren Geschäftsführern, Geschäftsführer der Gesellschaft. Es können jederzeit weitere Geschäftsführer ernannt werden.

(1) The Managing Director is managing director of the Company, together with other managing directors, if any. Additional managing directors can be appointed at any time.

 

 

 


 

(2) Der Geschäftsführer hat in der FMI-Organisation derzeit die Position des "General Manager Europe". Als solcher berichtet er – vorbehaltlich einer anderweitigen Bestimmung der Konzernspitze – an den President and COO, derzeit Herr Steve Kafka.

(2) The Managing Director's current position within the FMI-organization is "General Manager Europe". As such, the Managing Director reports to the President and COO, currently Steve Kafka, unless otherwise determined by the organization's top management.

 

(3) Dienstsitz des Geschäftsführers ist der Sitz der Gesellschaft, der zum Starttermin voraussichtlich am Nonnenwald 2, 82377 Penzberg, Deutschland, gelegen sein wird. Die Tätigkeit des Geschäftsführers ist mit Dienstreisen im In- und Ausland verbunden.

(3) The place of service is at the Company's seat, which is anticipated to be located at Nonnenwald 2, 82377 Penzberg, Germany. The Managing Director's activity will require business travels, including travels abroad.

 

 

§ 2Geschäftsführung /

VERTRETUNG

§ 2Management /

REPRESENTATION

 

(1) Der Geschäftsführer führt die Gesellschaft nach Maßgabe der Weisungen der jeweiligen Gesellschafterversammlung und unter Beachtung der gesetzlichen Bestimmungen sowie der Zustimmungserfordernisse, die die Satzung in ihrer jeweils gültigen Fassung bzw. die Gesellschafterversammlung jeweils aufstellen.

(1) The Managing Director shall manage the Company's business in accordance with the instructions of the respective shareholders' meeting and in observance of the statutory provisions, as well as in accordance with the approval requirements which the applicable articles of association or the respective shareholders' meeting establish.

 

(2) Der Geschäftsführer vertritt die Gesellschaft nach Maßgabe des Gesetzes, der Vorschriften der jeweils gültigen Satzung, und den Weisungen der jeweiligen Gesellschafterversammlung.

(2) The Managing Director represents the Company in accordance with the statutory provisions, the applicable articles of association and the instructions given by the respective shareholders' meeting.

 

(3) Die Gesellschafterversammlung kann - unbeschadet ihres Rechts zur Erteilung von Weisungen - eine Geschäftsordnung für die Geschäftsführer erlassen, welche die Aufgabenbereiche und Verantwortlichkeiten mehrerer Geschäftsführer gegeneinander abgrenzt. Die Bestimmungen einer etwaigen Geschäftsordnung und die Regelungen dieses Dienstvertrages sind sowohl bei der Führung der Geschäfte der Gesellschaft als auch bei Ausübung der Vertretungsmacht zu beachten

(3)  Irrespective of its right to give instructions, the shareholders' meeting can issue rules of procedure ( Geschäftsordnung ) for the managing directors, which demarcates the tasks and responsibilities of several managing directors. The provisions of such rules and the provisions of this Service Agreement have to be observed by the Managing Director in managing the Company's business as well as in representing the Company.


 

 


 

§ 3 LAUFZEIT UND KÜNDIGUNG

§ 3TERM AND TERMINATION

 

(1) Das Dienstverhältnis des Geschäftsführers unter diesem Dienstvertrag beginnt spätestens am 1. Januar 2017 und läuft auf unbestimmte Zeit.

(1) The Managing Director's service relationship under this Service Agreement commences on 1 January 2017 at the latest and runs for an indefinite period.

 

(2) Beide Parteien können den Dienstvertrag jederzeit ordentlich unter Einhaltung einer Frist von sechs Monaten zum Monatsende kündigen. Das Recht zur außerordentlichen Kündigung dieses Dienstvertrages bleibt unberührt.

(2)  Each Party can give ordinary notice at any time, under observation of a notice period of six months to the end of a calendar month. The right to terminate this Service Agreement for cause shall not be affected.

 

(3) Die Gesellschaft ist insbesondere bei Verstößen des Geschäftsführers gegen Weisungen der Gesellschafterversammlung berechtigt, das Dienstverhältnis außerordentlich zu kündigen. Etwaige Schadensersatzansprüche der Gesellschaft bleiben hiervon unberührt.

(3) In particular, the Company shall be entitled to terminate this Service Agreement for cause in case the Managing Director failed to comply with the instructions of the shareholders' meeting. The right of the Company to claim for damages, if any, shall remain unaffected.

 

(4) Jede Kündigung ist schriftlich zu erklären.

(4) Notice of termination must be given in writing.

 

(5) Die Gesellschaft ist berechtigt, den Geschäftsführer im Fall eines Widerrufs der Bestellung, im Fall der Amtsniederlegung durch den Geschäftsführer, bei einer sonstigen Beendigung der Organstellung oder bei einer Kündigung dieses Dienstvertrages von jeder weiteren Tätigkeit für die verbleibende Laufzeit dieses Dienstvertrages freizustellen. Die Freistellung des Geschäftsführers erfolgt unter Fortzahlung des zeitanteiligen Jahresfestgehalts nach § 4 Abs. (1) dieses Dienstvertrages und unter Anrechnung sämtlicher Urlaubsansprüche des Geschäftsführers. Die Verpflichtung des Geschäftsführers, vor der Aufnahme einer Tätigkeit im Sinne des § 11 Abs. (2) dieses Dienstvertrages die Genehmigung der Gesellschafterversammlung einzuholen, sowie die Verbote nach § 11 Abs. (2) und (3) dieses Dienstvertrages bleiben von einer solchen Freistellung unberührt.

(5) In case of a revocation of the Managing Director's appointment, in case of a resignation from the office by the Managing Director himself, in case of any other ending of the Managing Director's office, or in case of a termination of this Service Agreement, the Company shall be entitled to release the Managing Director from further activities during the remaining term of this Service Agreement ("garden leave"). In the event of such release, the Managing Director shall be entitled to receive the annual fixed salary under § 4 (1) of this Service Agreement pro rata temporis for the term of the release. The term of a release shall be set off against any vacation claims of the Managing Director. The Managing Director's obligation to obtain the consent of the shareholders' meeting prior to taking up activities as defined in § 11 (2) of this Service Agreement and the prohibitions pursuant to § 11 (2) and (3) of this Service Agreement shall not be affected by such a release.

 

(6) Dieser Dienstvertrag endet ohne Kündigung mit Ablauf des Monats, in dem der Geschäftsführer das Alter erreicht, ab dem er erstmals einen Anspruch auf ungekürzte gesetzliche Altersrente erwirbt.

(6) This Service Agreement shall terminate without notice at the end of the month in which the Managing Director reaches the age at which he is entitled to full statutory retirement benefits for the first time.


 

 


 

§ 4 BEZÜGE

§ 4 REMUNERATION

 

(1) Als Vergütung für seine Dienste erhält der Geschäftsführer während der Laufzeit dieses Dienstvertrages ein jährliches Bruttofestgehalt in Höhe von EUR 250.000. Das jährliche Bruttofestgehalt wird in zwölf gleichen Monatsraten am Ende eines jeden Kalendermonats gezahlt. Im Falle einer unterjährig beginnenden bzw. unterjährig endenden Vertragslaufzeit ist das Bruttofestgehalt pro rata temporis geschuldet. Das Bruttofestgehalt wird jährlich entsprechend den persönlichen Leistungen des Geschäftsführers und der wirtschaftlichen Lage der Gesellschaft überprüft und gegebenenfalls angepasst.

(1) During the term of this Service Agreement the Managing Director shall receive an annual gross fixed salary of EUR 250,000 as remuneration for his services. The annual gross fixed salary shall be payable in twelve equal instalments at the end of each calendar month. If this Service Agreement starts or ends during the course of a calendar year, the annual fixed salary shall be owed pro rata temporis . The gross fixed salary shall be subject to an annual review and can be adjusted dependent on the Managing Director's performance and on the economic situation of the Company.

 

(2) Der Geschäftsführer erhält die Möglichkeit, zusätzlich zu seinem Festgehalt nach § 4 (1) einen jährlichen Bonus in Höhe von bis zu 35 % seines Festgehalts nach § 4 (1) dieses Dienstvertrages zu erlangen. Der Bonus hängt ab von der Erreichung von Zielen, welche die Gesellschaft zu Beginn eines Kalenderjahres festlegt.

(2) In addition to his fixed salary according to § 4 (1), the Managing Director shall have the opportunity to earn an annual bonus of up to 35% of his fixed salary according to § 4 (1) of this Service Agreement. The annual bonus is dependent on the achievement of goals to be determined by the Company at the beginning of each calendar year.

 

(3) Andere Vergütung als nach vorstehenden Absätzen ist dem Geschäftsführer nicht geschuldet. Insbesondere sind keine Boni, Gratifikationen, Jahressonderzahlungen, Provisionen, etwaige Vergütung für Nacht-, Sonn- und Feiertagsarbeit oder für etwaige Mehrarbeit und Überstunden oder sonstige Vergütung von der Gesellschaft geschuldet oder gezahlt.

(3) The Managing Director is not entitled to any other remuneration claims besides the claims stated in the subparagraphs above. In particular no bonus payments or annual extra payments, premiums neither any remuneration for work at night, on Sundays and public holidays or any remuneration for additional work and overtime, if any, shall be owed or paid by the Company.

 

(4) Dem Geschäftsführer ist es nicht gestattet, seine Vergütungsansprüche ohne vorherige schriftliche Zustimmung der Gesellschaft an Dritte abzutreten und/oder zu verpfänden.

(4) The Managing Director is not entitled to transfer or pledge his remuneration claims to third parties without the Company's prior written consent.

 

§ 5AUSLAGEN

§ 5EXPENSES

 

Die Gesellschaft erstattet dem Geschäftsführer gegen Nachweis Auslagen für Dienstreisen sowie Repräsentation und Bewirtung von Geschäftspartnern entsprechend den jeweils gültigen Festlegungen der Gesellschaft und entsprechend den jeweils gültigen deutschen steuerrechtlichen Richtlinien.

The Company will reimburse the Managing Director for proved expenses for business trips, representation and entertaining business partners in accordance with applicable Company guidelines and in accordance with applicable German tax regulations.


 

 


 

§ 6 BETRIEBLICHE ALTERSVORSORGE

§ 6PENSIONS

 

Die Gesellschaft wird zugunsten des Geschäftsführers für die Dauer der Laufzeit dieses Dienstvertrages 10% seiner Beiträge zu einer privaten Altersvorsorge tragen, jedoch ein Maximum von EUR 25.000 pro Jahr. Etwaige anfallende Steuer trägt der Geschäftsführer.

For the term of this Service Agreement the Company shall pay 10% of the Managing Director's contributions to a private pension scheme, however up to a maximum of EUR 25,000 per year. Any tax is to be borne by the Managing Director.

 

§ 7 DIENSTWAGENPAUSCHALE

§ 7 CAR ALLOWANCE

 

Der Geschäftsführer erhält eine monatliche Dienstwagenpauschale in Höhe von EUR 900,00 brutto. Mit dieser Dienstwagenpauschale sind sämtliche Ansprüche des Geschäftsführers im Zusammenhang mit der dienstlichen Nutzung seines privaten KFZ abgegolten und erledigt. Dies gilt nicht für Ansprüche wegen Schäden, welche aus der Verletzung des Lebens, des Körpers oder der Gesundheit des Geschäftsführers resultieren und auf einer fahrlässigen Pflichtverletzung der Gesellschaft, oder auf einer vorsätzlichen oder fahrlässigen Pflichtverletzung eines gesetzlichen Vertreters der Gesellschaft oder Erfüllungsgehilfen der Gesellschaft beruhen. Ebenfalls gilt dies nicht für sonstige Schäden, soweit diese auf einer grob fahrlässigen Pflichtverletzung der Gesellschaft, oder auf einer vorsätzlichen oder grob fahrlässigen Pflichtverletzung eines gesetzlichen Vertreters der Gesellschaft oder Erfüllungsgehilfen der Gesellschaft beruhen.

The Managing Director shall receive a monthly car allowance in the amount of EUR 900.00 gross. The car allowance shall cover and settle all claims of the Managing Director regarding the use of his private car for operational purposes. This shall not apply to liability for damage from injury to life, body or health due to negligent breach of duty by the Company or intentional or negligent breach of duty by a legal representative of the Company or a person used to perform an obligation of the Company. Also, this shall not apply to liability for other damage arising from a grossly negligent breach of duty by the Company or from an intentional or grossly negligent breach of duty by a legal representative of the Company or a person used to perform an obligation of the Company.

 

§ 8Dienstunfähigkeit / Krankheit

§ 8 Incapacity for Work / ILLNESS

 

(1) Der Geschäftsführer wird die Gesellschaft unverzüglich über jeden Fall einer unvorhergesehenen Abwesenheit und deren voraussichtliche Dauer informieren und auf vordringlich zu erledigende Aufgaben hinweisen.

(1) The Managing Director shall inform the Company without undue delay about every case of unforeseen absence and he shall draw the Company's attention to any urgent tasks which are to be completed with priority.

 

(2) Dauert eine Dienstunfähigkeit aufgrund Krankheit oder Unfall länger als drei Kalendertage, hat der Geschäftsführer eine ärztliche Bescheinigung über das Bestehen der Dienstunfähigkeit sowie deren voraussichtliche Dauer spätestens an dem auf den dritten Kalendertag folgenden Arbeitstag vorzulegen. Die Gesellschaft ist berechtigt, die Vorlage der Dienstunfähigkeitsbescheinigung früher zu verlangen. Dauert die Dienstunfähigkeit länger als in der ärztlichen Bescheinigung angegeben, ist der Geschäftsführer verpflichtet, eine Folgebescheinigung spätestens am ersten Arbeitstag nach Ablauf der vorhergehenden ärztlichen Bescheinigung vorzulegen.

(2) If an incapacity for work due to illness or accident lasts longer than three calendar days, the Managing Director shall submit a medical certificate regarding his inability to work and stating the probable duration of such condition no later than on the first working day following the third calendar day. The Company may demand submission of such a certificate of incapacity for work at an earlier time. If the incapacity for work lasts longer than stated in the medical certificate, the Managing Director shall submit a follow-up certificate of incapacity for work no later than on the first working day after the previous medical certificate expires.

 

 


 

 

(3) Im Falle unverschuldeter, die Durchführung seiner Aufgaben ausschließender Krankheit oder sonstiger unverschuldeter Dienstunfähigkeit während seiner Anstellung hat der Geschäftsführer Anspruch auf Fortzahlung seines zeitanteiligen Bruttojahresfestgehalts nach § 4 Abs. (1) dieses Dienstvertrages für die Dauer von sechs Wochen, längstens jedoch bis zur Beendigung dieses Dienstvertrags.

(3) In case of sickness or any other incapacity for work preventing the Managing Director without his personal responsibility from performing his duties, the Managing Director's pro-rated annual fixed salary under § 4 (1) of this Service Agreement shall continue to be paid for the maximum term of six weeks, however until the end of this Service Agreement at the longest.

 

(4) Dauert die Krankheit oder Dienstunfähigkeit länger als sechs Wochen, erhält der Geschäftsführer nach Vorlage eines ärztliches Attests, aus dem sich die Dienstunfähigkeit und deren voraussichtliche Dauer ergeben, ab diesem Zeitpunkt bis zum Ende des sechsten Monats nach Beginn der Dienstunfähigkeit die Differenz zwischen den Zahlungen der Krankenversicherung und seinem zeitanteiligen Netto-Festgehalt als Zuschuss zum Krankengeld/Krankentagegeld, längstens jedoch bis zur Beendigung dieses Dienstvertrags. Etwaige auf die Zahlungen der Gesellschaft anfallende Steuer trägt der Geschäftsführer.

(4) If the sickness or incapacity for work continues beyond six weeks, the Managing Director shall receive the difference between payments of his health insurance and his pro-rated net fixed base salary after this date until the end of the sixth month after the start of the sickness, however until the end of this Service Agreement at the longest. Payment is subject to submission of a medical certificate showing the incapacity for work and its expected duration. Any tax on the payments of the Company is to be borne by the Managing Director.

 

§ 9URLAUB

§ 9VACATION LEAVE

 

(1) Der Geschäftsführer hat Anspruch auf einen bezahlten Jahresurlaub von 30 Arbeitstagen pro Kalenderjahr. Arbeitstage im Sinne dieser Bestimmung sind alle Kalendertage mit Ausnahme von Samstagen, Sonntagen und gesetzlichen Feiertagen am jeweiligen satzungsmäßigen Sitz der Gesellschaft. Bei unterjährigem Beginn dieses Dienstvertrages bzw. unterjähriger Beendigung dieses Dienstvertrages wird der Urlaub zeitanteilig gewährt. Den Zeitpunkt des Urlaubs bestimmt der Geschäftsführer in Abstimmung mit dem oder den anderen Geschäftsführer(n) und der Gesellschafterversammlung sowie unter Wahrung der Belange der Gesellschaft.

(1) The Managing Director is entitled to 30 working days paid annual vacation leave for each calendar year. Working days within the meaning of this provision are all calendar days except for Saturdays, Sundays and public holidays at the Company's place of business stated by the applicable articles of association. If this Service Agreement begins and/or ends during the course of a calendar year, the annual vacation leave shall be granted pro rata temporis. The Managing Director shall determine the time of his vacation in coordination with the other managing director(s) and the shareholders' meeting while observing the interests of the Company.

 

(2) Der gesamte Urlaub ist im laufenden Kalenderjahr zu nehmen. Eine Übertragung des Urlaubs auf das nächste Kalenderjahr erfolgt nur, wenn die Parteien dies vereinbart haben. Ansonsten verfällt der Urlaubsanspruch mit Ende des Kalenderjahres ersatzlos. Ein Entschädigungsanspruch für nicht beanspruchte Urlaubstage besteht nicht.

(2) The entire annual vacation leave has to be taken during the respective calendar year. Vacation leave may be carried forward to the next calendar year only if this was agreed between the Parties. If it was not agreed untaken vacation shall be forfeited. There is no entitlement to compensation for days of vacation which were not taken.


 

 


 

 

§ 10ÜBERNAHME VON ÄMTERN UND MANAGEMENT-FUNKTIONEN

§ 10ASSUMPTION OF OFFICES AND MANAGEMENT FUNCTIONS

 

(1) Auf Wunsch der Gesellschafterversammlung wird der Geschäftsführer Aufsichtsratsmandate, Vorstandsämter und andere Geschäftsführungspositionen sowie Management-Funktionen in Gesellschaften, mit denen die Gesellschaft bzw. die Foundation Medicine, Inc. unmittelbar oder mittelbar im Sinne des § 15 AktG verbunden ist (" Verbundene Unternehmen "), übernehmen. Auf Wunsch der Gesellschafterversammlung wird der Geschäftsführer auch Tätigkeiten in Verbänden oder Ehrenämter übernehmen. Die Parteien sind sich einig, dass mit der Übernahme von Ämtern oder Management-Funktionen wie auch mit der Tätigkeit nach diesem Dienstvertrag umfangreiche Reisetätigkeiten notwendig werden können.

(1) At the request of the shareholders’ meeting, the Managing Director shall assume supervisory board mandates, other management board offices and management positions as well as similar offices in companies, in which the Company or Foundation Medicine, Inc. is directly or indirectly affiliated within the meaning of § 15 of the German Stock Companies Act [ AktG ] (" Affiliates "). At the request of the shareholders' meeting the Managing Director shall also take up activities in associations or honorary positions. The Parties agree that the assumption of such offices or management positions as well as the activity under this Service Agreement may require extensive travel activities.

 

(2) Die in diesem § 10 genannten Tätigkeiten sind mit dem Bruttojahresfestgehalt nach § 4 Abs. (1) dieses Dienstvertrages vollständig abgegolten. Soweit der Geschäftsführer gleichwohl für eine Tätigkeit im Sinne dieser Vorschrift eine Vergütung erhält, wird diese auf das Bruttojahresfestgehalt nach obigem § 4 Abs. (1) angerechnet.

(2) The activities listed in this § 10 shall be fully covered by the annual fixed salary stipulated under § 4 (1) of this Service Agreement. If the Managing Director receives remuneration for activities listed in this provision, this remuneration will be set-off against the annual gross fixed salary stipulated under § 4 (1) above.

 

(3) Der Geschäftsführer ist verpflichtet, etwaige nach dieser Regelung übernommene Ämter und Funktionen unverzüglich niederzulegen, wenn seine Bestellung zum Geschäftsführer widerrufen wird, der Dienstvertrag gekündigt wird, der Geschäftsführer sein Amt als Geschäftsführer niederlegt, das Amtsverhältnis aus sonstigen Gründen endet oder die Gesellschafterversammlung dies wünscht.

(3) The Managing Director is obliged to resign from any offices and functions assumed according to this provision without undue delay if his appointment as Managing Director is revoked, the Service Agreement is terminated, the Managing Director resigns from his office as Managing Director, the appointment ends for other reasons or the shareholders' meeting requests this.

 

§ 11DIENSTZEIT / NEBENTÄTIGKEITEN / WETTBEWERBSVERBOT

§ 11WORKING HOURS / SIDE ACTIVITIES / NON-COMPETITION

 

(1) Der Geschäftsführer wird der Gesellschaft seine volle Arbeitskraft widmen und die Interessen der Gesellschaft nach besten Kräften fördern. In der Bestimmung seiner Arbeitszeit ist der Geschäftsführer frei, hat der Gesellschaft aber stets in dem Umfang zur Verfügung zu stehen, den die Wahrnehmung der Interessen und Belange der Gesellschaft erfordern.

(1) The Managing Director shall devote his full working capacity to the Company and shall undertake his best efforts to promote the interests of the Company. The Managing Director may determine his working hours at his own discretion, but he shall be available for the Company to the extent required to safeguard the Company's interests.

 

 

 

 


 

(2) Jede weitere entgeltliche oder unentgeltliche Tätigkeit sowie jegliche Beteiligung an Unternehmen bedarf der vorherigen ausdrücklichen schriftlichen Zustimmung der Gesellschafterversammlung. Bei Vorliegen sachlicher Gründe, insbesondere einer Beeinträchtigung der Tätigkeit des Geschäftsführers für die Gesellschaft, kann eine etwaige Zustimmung jederzeit widerrufen werden. Der Geschäftsführer hat bei Ausübung jeglicher Nebentätigkeit eine strikte Loyalitätspflicht gegenüber der Gesellschaft und Verbundenen Unternehmen und wird im Rahmen des Betreibens dieser Nebentätigkeiten deren geschäftliche oder etwaige sonstige Interessen nicht beeinträchtigen. Ausgenommen von der Zustimmungspflicht ist der übliche Erwerb von Wertpapieren zu Zwecken der persönlichen Vermögensverwaltung.

(2) Any kind of paid or unpaid activity as well as any investments in businesses shall be subject to prior explicit written consent from the shareholders’ meeting. For objective reasons, in particular if the Managing Director’s services for the Company suffer any adverse effects, any such consent may be revoked at any time. In performing any side activities the Managing Director shall exercise a strict duty of loyalty vis-à-vis the Company and Affiliates and in the course of carrying out the side activities shall not derogate from the business interests or any other interests of the Company and Affiliates. The customary acquisition of securities for purposes of personal asset management shall be excluded from the duty to obtain consent.

 

(3) Der Geschäftsführer wird nicht ohne vorherige schriftliche Zustimmung der Gesellschafterversammlung während der Dauer dieses Dienstvertrages in selbständiger, unselbständiger oder sonstiger Weise für ein Unternehmen tätig werden, welches mit der Gesellschaft oder einem mit der Gesellschaft Verbundenen Unternehmen in direktem oder indirektem Wettbewerb steht oder in wesentlichen Umfang Geschäftsbeziehungen zu der Gesellschaft oder einem mit ihr Verbundenen Unternehmen unterhält. In gleicher Weise ist es dem Geschäftsführer untersagt, während der Dauer dieses Dienstvertrags ein solches Unternehmen zu errichten, zu erwerben oder sich hieran unmittelbar oder mittelbar zu beteiligen. Dies bezieht sich auch auf eine Mitgliedschaft in Aufsichts- oder Beiräten anderer Gesellschaften oder sonstigen Institutionen, die im Zusammenhang mit dem Geschäftsgegenstand der Gesellschaft stehen oder sonst die Interessen der Gesellschaft berühren.

(3) During the term of this Service Agreement the Managing Director shall not work without the prior written consent of the shareholders' meeting as a self-employed person for, or as an employee of a company or otherwise work for a company, if such company is a direct or indirect competitor of the Company or an Affiliate, or maintains material business relationships with the Company or an Affiliate. In the same way the Managing Director shall not establish, acquire or directly or indirectly participate in such company during the term of this Service Agreement. This shall also apply to memberships in supervisory or advisory boards of other companies or other institutions in connection with the Company's business purpose or which otherwise affect the Company's interests.


 

 


 

 

§ 12Abwerbeverbot und Vertragsstrafe

§ 12Non-Solicitation / contractual PENALTY

 

(1) Der Geschäftsführer wird während des Anstellungsverhältnisses und für die Dauer von einem Jahr nach dessen Beendigung weder selbst noch durch andere, weder direkt noch indirekt, einen Mitarbeiter der Gesellschaft aktiv abwerben bzw. ihn aktiv dazu veranlassen, sein Vertragsverhältnis mit der Gesellschaft zu beenden, um in einem Anstellungsverhältnis, in einem freien Dienstverhältnis oder in sonstiger Weise für andere in seiner bisherigen oder einer vergleichbaren Funktion mit Bezug zum gleichen Arbeitsbereich tätig zu werden.

(1) During the term of this Service Agreement and for a period of one year after the termination of his employment, the Managing Director shall neither personally nor through third parties, neither directly nor indirectly, actively solicit any employee of the Company, or induce any employee of the Company to terminate his employment, in order to act as an employee, a freelancer or in another way for another person in the same or in a similar capacity with relation to the same field of work.

 

(2) Der Geschäftsführer wird auch keine Aktivitäten entsprechend vorstehendem Absatz (1) entfalten, um Mitarbeiter der Gesellschaft zu veranlassen, in einem Anstellungsverhältnis oder freien Dienstverhältnis oder in sonstiger Weise für ihn selbst tätig zu werden.

(2) Furthermore, the Managing Director shall not engage in any activities according to the preceding subpara. (1) in order to induce any employee of the Company to act as an employee, a freelancer or in another way for himself.

 

(3) Sofern der Geschäftsführer gegen seine Verpflichtungen aus dem nachvertraglichen Abwerbungsverbot verstößt, kann die Gesellschaft von ihm für jeden Fall der Zuwiderhandlung eine Vertragsstrafe in Höhe von 50% der zuletzt bezogenen monatlichen Vergütung (ist gleich Jahresfestgehalt gemäß § 4 Abs. 1 dieses Dienstvertrags geteilt durch 12) verlangen. Die Geltendmachung sonstiger Ansprüche durch die Gesellschaft, insbesondere auf Unterlassung und auf Ersatz eines weitergehenden Schadens, bleibt hiervon unberührt.

(3) In case the Managing Director fails to comply with the post-contractual non-solicitation the Company shall be entitled to demand a contractual penalty in the amount of 50% of the last monthly fixed remuneration received by the Managing Director (equals to 1/12 of the annual fixed salary pursuant to § 4 (1) above) for each case of violation. The demand for other claims by the Company shall not be affected, especially injunctive relief and claims for further damages.

 

§ 13GEHEIMHALTUNG

§ 13Confidentiality

 

 

 


 

(1) Der Geschäftsführer verpflichtet sich, über alle ihm im Rahmen seiner Tätigkeit zur Kenntnis gelangenden geschäftlichen und betrieblichen Angelegenheiten der Gesellschaft und der Verbundenen Unternehmen, strengstes Stillschweigen zu bewahren, diese Informationen nicht für den eigenen oder den Nutzen anderer zu verwenden und alle solche geschäftlichen und betrieblichen Angelegenheiten betreffenden Geschäftsunterlagen der Gesellschaft und der Verbundenen Unternehmen unter Verschluss zu halten. Unter geschäftlichen und betrieblichen Angelegenheiten im Sinne dieser Regelung verstehen die Parteien insbesondere Geschäfts- und Betriebsgeheimnisse sowie alle Informationen mit Bezug zu vertraulichen Angelegenheiten und

geschäftsbezogenem Know-how, sämtliche Informationen über alle mit dem existenten oder künftigen Geschäft der Gesellschaft und der Verbundenen Unternehmen in Zusammenhang stehenden Geschäftspläne und Geschäftsstrategien, Preis- oder Marktstrategien und Produkt-, Dienstleistungs- oder Entwicklungsplanungen, geplante Unternehmenserwerbe oder -veräußerungen, sämtliche Geschäftszahlen und Details der organisatorischen Strukturen, sowie die wesentlichen Ideen und Prinzipien, welche diesen Strategien und Planungen zugrunde liegen, und alle Informationen, von denen vernünftigerweise erwartet werden kann, dass sie zu solchen Strategien oder Planungen führen würden und die von der Gesellschaft, von Verbundenen Unternehmen oder dem Geschäftsführer während der Dauer dieses Dienstvertrags erdacht, erfunden, überarbeitet, entdeckt, entwickelt, erworben, beurteilt, getestet oder angewendet worden sind.

(1) The Managing Director undertakes to maintain strictest confidentiality with regard to all business and operational matters of the Company or of Affiliates of which he obtained knowledge within the scope of his activity, not to use such information for his own benefit or the benefit of third parties and to keep under lock and key all business documents relating to such business and operation matters of the Company and any of its Affiliates. Business and operational matters within the meaning of this provision as understood by the parties are notably trade and business secrets as well as any information relating to confidential matters and business-related know-how, any information on business plans and business strategies, and price and market strategies, product, service or development plans, planned company acquisitions or company sales, all business figures and details on the organisational structures relating to the existing or future business of the Company and its Affiliates, as well as the material ideas and principles underlying such strategies and structures, and any information that could reasonably be expected to result in such strategies or plans and which was conceived, invented, reviewed, discovered, developed, acquired, assessed, checked or applied by the Company, its Affiliates or the Managing Director during the term of this Service Agreement.

 

(2) Nach Beendigung dieses Dienstvertrages gilt die Verschwiegenheitsverpflichtung gemäß vorstehendem Absatz (1) fort. Im Rahmen einer von dem Geschäftsführer dann ausgeübten beruflichen oder unternehmerischen Tätigkeit kann er sein während der Dauer dieses Dienstvertrages erworbenes Wissen einsetzen, sofern dabei die gesetzlichen Beschränkungen - insbesondere §§ 3, 17 UWG, §§ 823, 826 BGB sowie das Bundesdatenschutzgesetz - strikt beachtet werden.

(2) After the end of this Service Agreement the confidentiality obligation as set forth in the preceding subparagraph (1) shall continue to apply. In case of a then exercised professional or entrepreneurial activity of the Managing Director, he can make use of his knowledge acquired during the term of the Service Agreement, provided the statutory limitations, including but not limited to those set forth in §§ 3, 17 of the German Act against Unfair Competition [ UWG ], §§ 823, 826 of the German Civil Code [ BGB ] and the German Federal Data Protection Act [ BDSG ], are strictly observed.

 

§ 14nachvertragliches Wettbewerbsverbot; Vertragsstrafe

§ 14Post-Contractual non-compete; contractual penalty

 

(1) Nach Beendigung des Dienstverhältnisses ist es dem Geschäftsführer für eine Dauer von einem Jahr untersagt, mit der Gesellschaft oder einem Verbundenen Unternehmen in Wettbewerb zu treten („nachvertragliches Wettbewerbsverbot"). Dieses nachvertragliche Wettbewerbsverbot bezieht sich

 

(1) For a period of one year after the termination of this Service Agreement, the Managing Director shall be bound by a post-contractual non-compete obligation covering the Company and Affiliates, and

     sachlich auf den Schwerpunkt der Geschäftstätigkeit der Gesellschaft oder eines Verbundenen Unternehmens zu dem Zeitpunkt, in dem dieser Dienstvertrag endet, und

 

     as regards content: the main focus of the business activity of the Company or the Affiliate by the time this Service Agreement is terminated, and

 

 


 

      räumlich auf das gesamte Tätigkeitsgebiet der Gesellschaft oder eines Verbundenen Unternehmens zu dem Zeitpunkt, in dem dieser Dienstvertrag endet, vorausgesetzt, dass der Geschäftsführer bei der jeweiligen Gesellschaft zu dem Zeitpunkt, in dem dieser Anstellungsvertrag endet, tätig ist oder in den letzten zwölf Monaten vor Beendigung dieses Anstellungsvertrages mindestens drei Monate tätig war.

 

     regionally: all territories the Company or the Affiliate develop business activities in by the time this Service Agreement is terminated; subject, however, to the condition that the Managing Director has been working at the respective company for at least three months during the last twelve months before this Service agreement is terminated or at the time of termination.

Sachlicher und räumlicher Geltungsbereich des nachvertraglichen Wettbewerbsverbots werden zusammenfassend als „Geschäftsbereich" bezeichnet.

 

(further referred to as "business activities")

Das nachvertragliche Wettbewerbsverbot umfasst jede Wettbewerbstätigkeit im Geschäftsbereich der Gesellschaft oder einem Verbundenen Unternehmen, sei es direkt oder indirekt, selbständig, als freier Mitarbeiter, arbeitnehmerähnlich oder als Arbeitnehmer/Angestellter, als Geschäftsführer, durch Errichtung eines oder Beteiligung an einem Wettbewerbsunternehmen, durch beratende Tätigkeit oder auf sonstige Weise. Hiervon ausgenommen sind lediglich rein finanzielle Beteiligungen an börsennotierten Unternehmen bis zur Höhe von 2 % des Kapitals, die keine unternehmerischen Einflussmöglichkeiten eröffnen.

The post-contractual non-compete obligation shall cover every competitive activity of the Managing Director to the business activity of the Company or an Affiliate, directly or indirectly, in an employment, on a freelance basis, in a managing director or consultant or any other capacity. During the period of the post-contractual non-compete obligation it is also prohibited to establish a competitive company, as well as to acquire a competitive company or to participate or invest in it directly or indirectly. Excluded from the prohibition of participation and investment shall be the acquisition of securities up to 2%, provided that these do not allow for influence on the management.

 

(2) Die Gesellschaft verpflichtet sich, dem Geschäftsführer für die Dauer des nachvertraglichen Wettbewerbsverbots eine Karenzentschädigung zu zahlen, die für jeden Monat des Verbots 50% der vom Geschäftsführer zuletzt bezogenen monatlichen Vergütung (ist gleich Jahresfestgehalt gemäß § 4 Abs. 1 dieses Dienstvertrags geteilt durch 12) erreicht. Etwaige Nebenleistungen werden bei der Berechnung nicht berücksichtigt.  

(2) For the period of the post-contractual non-compete obligation, the Company shall pay to the Managing Director compensation as a consideration for compliance with the post-contractual non-compete covenant, which for each month of prohibition reaches 50% of the last monthly fixed remuneration received by the Managing Director (equals to 1/12 of the annual fixed salary pursuant to § 4 (1) above). Further remuneration, if any, will not be taken into account.

 

(3) Die Gesellschaft kann vor Beendigung dieses Anstellungsvertrags durch schriftliche Erklärung mit der Wirkung auf das nachvertragliche Wettbewerbsverbot verzichten, dass sie mit Ablauf von sechs Monaten seit der Erklärung von der Verpflichtung frei wird, die Karenzentschädigung zu zahlen.

(3) Until termination of the Service Agreement the Company can waive the post-contractual non-compete covenant in writing with the effect that upon expiration of six months after such declaration, the obligation to pay compensation pursuant to § 14 (2) above shall no longer apply.

 

(4) Das nachvertragliche Wettbewerbsverbot tritt nicht in Kraft, wenn dieser Dienstvertrag aufgrund Eintritts des Geschäftsführers in den Ruhestand oder wegen Invalidität des Geschäftsführers endet.

(4) The post-contractual non-compete covenant shall not apply, if the termination of the Service Agreement becomes effective at a time, where the Managing Director qualifies for the statutory old-age pension or due to disability.

 

 


 

 

(5) Für jede Handlung, durch die der Geschäftsführer das nachvertragliche Wettbewerbsverbot nach obenstehendem § 14 (1) schuldhaft verletzt, hat er eine Vertragsstrafe in Höhe von 50 % der vom Geschäftsführer zuletzt bezogenen monatlichen Vergütung (ist gleich Jahresfestgehalt gemäß § 4 Abs. (1) dieses Dienstvertrags geteilt durch 12) zu zahlen. Die Vertragsstrafe wird für jeden angefangenen Kalendermonat, in dem die Verletzungshandlung fortbesteht, neu verwirkt. (" Dauerverstoß "). Dies gilt auch im Falle einer fortgesetzten Konkurrenztätigkeit im Rahmen der verbotswidrigen Eingehung eines Dauerschuldverhältnisses, insbesondere eines Arbeits- oder Dienstverhältnisses (als freier Mitarbeiter, Handelsvertreter oder Berater) oder bei der Errichtung eines Konkurrenzunternehmens oder der Beteiligung an einem Konkurrenzunternehmen. Anders als in den im vorstehenden Satz genannten Fällen liegt ein Dauerverstoß nicht vor, wenn lediglich die Folgen eines einmaligen Verstoßes fortwirken und der Geschäftsführer diese Fortwirkungen nicht beenden kann. Die Geltendmachung sonstiger Ansprüche durch die Gesellschaft, insbesondere auf Unterlassung und auf Ersatz eines weitergehenden Schadens, bleibt hiervon unberührt. Die Zahlung einer Vertragsstrafe nach diesem § 14 (5) wird auf den Anspruch der Gesellschaft auf Schadensersatz wegen Verstoßes gegen die Pflichten aus diesem § 14 angerechnet.

(5) If the Managing Director breaches any of the covenants set forth in this § 14 (1) then the Managing Director shall be required to pay a contractual penalty ( Vertragsstrafe ) in the amount of 50% of the last monthly fixed remuneration received by the Managing Director (equals 1/12 of the annual fixed salary pursuant to § 4 (1) above) to the Company. In case of a continuing violation the Managing Director shall pay for each further calendar month during which or part of which the violation continues a further contractual penalty (" Continuing Violation "). This also applies in the case of a violation due to a continued competitive activity during a continuing contractual obligation, in particular an employment or service agreement (as freelancer, commercial agent or consultant) or in case of establishing a competitive company or participation in a competitive company. Other than the circumstances set out in the preceding sentence, a Continuing Violation shall exist only if the consequences of an individual violation continue to exist and the Managing Director is not able to terminate this continuing violation. Any rights of the Company to request any additional damages or to request the Managing Director from discontinuing the violation of this covenant shall remain unaffected. Any contractual penalty paid to the Company pursuant to this § 14 (5) shall count against the claim of the Company for compensation of damages pursuant to this § 14 based on such breach.

 

(6) Für den Fall, dass eine Bestimmung dieses § 14 unwirksam sein sollte, berührt dies nicht die Wirksamkeit der übrigen Regelungen.

(6) If any (part of a) provision of this § 14 is or becomes invalid or unenforceable, the validity or enforceability of the remaining provisions of this Service Agreement shall not be affected thereby.

 

(7) Im Übrigen gelten für das nachvertragliche Wettbewerbsverbot die Vorschriften der §§ 74 ff. HGB mit Ausnahme des § 75 Abs. 2 HGB entsprechend, soweit sie Regelungen zu Gunsten der Gesellschaft treffen.

(7) §§ 74 seq. of the German Commercial Code [ Handelsgesetzbuch ] apply in addition to the extent they make provisions beneficial to the Company with the exception of § 75 (2) German Commercial Code.

 


 

 


 

§ 15 SCHUTZRECHTE

§ 15INtellectual Property

 

(1) Der Geschäftsführer überträgt der Gesellschaft ausschließliche, zeitlich, räumlich und inhaltlich unbeschränkte Nutzungs- und Verwertungsrechte für alle etwaigen nach dem Urhebergesetz (UrhG) schutzfähigen Arbeitsergebnisse, die der Geschäftsführer während der Laufzeit seines Dienstvertrages während seiner Arbeitszeit oder, sofern sie Bezug zu seinen dienstvertraglichen Aufgaben haben, auch außerhalb seiner Arbeitszeit erstellt. Die Übertragung der urheberrechtlichen Nutzungs- und Verwertungsrechte umfasst auch etwaige bei Vertragsschluss noch unbekannte Nutzungsarten. Die Übertragung der Nutzungs- und Verwertungsrechte umfasst insbesondere auch die Erlaubnis zur Bearbeitung und Lizenzvergabe an Dritte mit der Erlaubnis zur Unterlizensierung. Der Geschäftsführer verzichtet ausdrücklich auf sonstige ihm etwa als Urheber zustehende Rechte an den Arbeitsergebnissen, insbesondere auf das Recht auf Namensnennung, auf Bearbeitung und auf Zugänglichmachung des Werkes.

(1) The Managing Director shall assign to the Company the exclusive user or exploitation rights unlimited as to time, territory and content to any and all work results he produced during the term of this Service Agreement with the Company during his working hours or - to the extent they are related to his tasks under this Service Agreement - also outside of his working hours, and which are protectable under the German Copyright Act [ UrhG ]. The rights assigned to the Company pursuant to the preceding sentence shall also include user rights which are not known at the time this Service Agreement was entered into. The rights assigned to the Company shall further include the permission for processing and licensing third parties with permission for sub-licensing. The Managing Director expressly waives all other rights regarding the work results which he might be entitled to as author/creator, which shall especially include the right to be named as author/creator, the right to process and the right to grant access to the work result.

 

(2) Der Gesellschaft stehen die Arbeitsergebnisse zu, die der Geschäftsführer während der Dauer seines Dienstvertrages während seiner Arbeitszeit oder, sofern sie Bezug zu seinen arbeitsvertraglichen Aufgaben haben, auch außerhalb seiner Arbeitszeit erstellt und die eine patent- oder gebrauchsmusterfähige Erfindung beinhalten. Der Geschäftsführer hat diese Erfindungen der Gesellschaft unverzüglich anzuzeigen. Soweit die Gesellschaft die Erfindung in Anspruch nimmt, gehen alle vermögenswerten Rechte an der Erfindung, insbesondere Rechte nach dem Patentgesetz oder dem Gebrauchsmustergesetz, nach Maßgabe des Gesetzes über Arbeitnehmererfindungen ( ArbnErfG ) auf die Gesellschaft über.

(2) The Company shall own the work results the Managing Director produced during the term of this Service Agreement with the Company during his working hours or - to the extent they are related to his tasks under this Service Agreement - also outside of his working hours, and which are inventions protectable under utility model or patent law. The Managing Director shall be obliged to notify the Company without undue delay whenever he has made such an invention. As far as the Company makes use of the invention all intangible assets related to this invention, especially with regard to rights under the German Patent Act or the German Utility Model Act, shall be assigned to the Company in accordance with the German Employee Inventions Act [ ArbnErfG ].

 

(3) Soweit Arbeitsergebnisse, die der Geschäftsführer während der Dauer seines Dienstvertrages während seiner Arbeitszeit oder, sofern sie Bezug zu seinen dienstvertraglichen Aufgaben haben, auch außerhalb seiner Arbeitszeit erstellt, nicht bereits nach Abs. (1) und (2) übertragen sind, überträgt der Geschäftsführer der Gesellschaft sämtliche Rechte an diesen Arbeitsergebnissen, insbesondere Marken- und sonstige Kennzeichenrechte sowie Geschmacksmusterrechte.

(3) As far as work results which the Managing Director produced during the term of this Service Agreement with the Company during his working hours or - to the extent they are related to his tasks under this Service Agreement - also outside of his working hours are not being assigned to the Company under the preceding subparagraphs (1) and (2), the Managing Director shall assign to the Company all rights related to the work result, especially trade mark and other sign rights as well as industrial design rights.

 

 


 

 

(4) Eine Verpflichtung der Gesellschaft zur Ausübung, Anmeldung oder Verwertung der vorstehend übertragenen oder eingeräumten Rechte besteht nicht. Das dem Geschäftsführer nach § 41 UrhG eventuell zustehende Rückrufrecht wegen Nichtausübung der jeweils eingeräumten Nutzungsrechte ist für die Dauer von fünf Jahren ab deren Einräumung ausgeschlossen. Der Rückruf kann erst erklärt werden, nachdem der Geschäftsführer der Gesellschaft eine Nachfrist von zwei Jahren unter Aufforderung zu im Einzelnen bezeichneten Nutzungen gesetzt hat soweit vorstehend nicht anders geregelt.

(4) The Company is not obliged to execute, apply for or exploit the aforementioned transferred and/or granted rights. The recall right based on non-execution of granted rights of use according to sec. 41 UrhG, which the Managing Director might be entitled to, is excluded for five years starting from the grant of the respective rights. The recall right may only be executed after the Managing Director has set an extension of time of two years together with requesting the execution of the respective identified use except as agreed otherwise above.

 

(5) Die Einräumung von Rechten und der Verzicht auf Rechte nach diesem § 15 sind vollumfänglich mit dem in § 4 Abs. (1) geregelten Bruttojahresfestgehalt abgegolten.

(5) The assignment and the waiver of rights under this § 15 shall be fully compensated by the annual fixed salary as agreed on in the above § 4 (1).

 

(6) Der Geschäftsführer wird auf Verlangen der Gesellschaft diese bei der Erlangung Schutzrechten für die Arbeitsergebnisse im In- und Ausland unterstützen. Für die Erfüllung dieser Mitwirkungspflichten erhält der Geschäftsführer keine weitere Vergütung. Kosten, die ihm durch das Verlangen der Gesellschaft entstanden sind, werden ihm jedoch erstattet.

(6) Upon the Company's request the Managing Director shall assist the same with obtaining intellectual property rights for the work results in Germany and abroad. The Managing Director shall not obtain any further remuneration for fulfilling his cooperation duties with the exception of any costs incurred to him at the Company's request.

 

§ 16 RÜCKGABE VON GEGENSTÄNDEN UND UNTERLAGEN

§ 16RETURN OF ITEMS AND DOCUMENTS

 

(1) Der Geschäftsführer wird auf Verlangen der Gesellschaft jederzeit und spätestens bei Beendigung dieses Dienstvertrages bzw. bei Beginn einer etwaigen Freistellung entsprechend § 3 Abs. (5) dieses Dienstvertrages unaufgefordert alle in seinem Besitz befindlichen Gegenstände, die im Eigentum der Gesellschaft oder Verbundener Unternehmen stehen oder ihm von der Gesellschaft oder Verbundenen Unternehmen überlassen wurden, insbesondere auch Akten und sonstige, den Geschäftsbetrieb der Gesellschaft oder Verbundener Unternehmen betreffende Unterlagen (insbesondere Druckmaterial, Urkunden, Notizen, Entwürfe) sowie Kopien davon oder elektronische Speichermedien, die den Inhalt derartiger Unterlagen enthalten sowie Kopien davon, an die Gesellschaft zurückgeben.

(1) Upon request of the Company, the Managing Director will at all times, however, at the latest upon termination or at the beginning of the release period according to § 3 (5) above - without request - return to the Company all objects the Managing Director holds which are owned by the Company or Affiliates or which had been entrusted to the Managing Director by the Company or an Affiliates; this includes in particular files and other documentation relating to the Company's business or that of Affiliates (in particular, all print material, deeds, notes, drafts) as well as copies thereof or electronic recording media containing the contents of such documentation as well as copies thereof.

 


 

 


 

 

(2) Diese Rückgabeverpflichtung gilt insbesondere auch für etwaige dem Geschäftsführer überlassene Gegenstände wie Laptop, Blackberry oder Mobiltelefon, auch wenn insoweit die private Nutzung gestattet war.

(2) The obligation to return documentation also applies to items, such as laptop/notebook, Blackberry or mobile phone which may have been given to the Managing Director, also if private use had been permitted.

 

(3) Der Geschäftsführer hat an den vorab bezeichneten Unterlagen und Gegenständen kein Zurückbehaltungsrecht.

(3) The Managing Director has no right of retention in the documents and items mentioned above.

 

§ 17Ausschlussfristen

§ 17Forfeiture of claims

 

(1) Alle beiderseitigen Ansprüche der Vertragsparteien aus diesem Dienstvertrag oder im Zusammenhang damit verfallen, wenn sie nicht innerhalb von sechs Monaten nach Fälligkeit schriftlich gegenüber der anderen Vertragspartei geltend gemacht werden. Lehnt der Anspruchsgegner den Anspruch ab oder äußert er sich nicht innerhalb von zwei Wochen nach der schriftlichen Geltendmachung nach Satz 1 (" Äußerungsfrist "), verfallen die Ansprüche, wenn sie nicht innerhalb einer weiteren Frist von sechs Monaten nach der Ablehnung oder nach dem Ablauf der Äußerungsfrist gerichtlich geltend gemacht werden.

(1) All reciprocal claims of the parties arising from or in connection with this Service Agreement forfeit unless they are asserted in writing vis-à-vis the other party within six months after falling due. If the respondent of the claim rejects the claim or does not make any statement within two weeks of written assertion of the claim (" Statement Period "), the claims shall be deemed forfeited unless they are asserted before a court within a further period of six months after the rejection or the expiry of the Statement Period.

 

(2) Das Versäumen der jeweiligen Ausschlussfrist führt zum Verlust des Anspruchs. Die Ausschlussfrist beginnt, wenn der Anspruch entstanden ist und der Anspruchsteller von den anspruchsbegründenden Umständen Kenntnis erlangt oder grob fahrlässig keine Kenntnis erlangt hat.

(2)  The lapse of the respective forfeiture period leads to a loss of the claim. The forfeiture period starts to run once the claim has arisen and the claimant has obtained knowledge or has not obtained knowledge in gross negligence of the circumstances giving rise to the claim.

 

(3) Die Ausschlussfristen gemäß vor-stehendem Absatz (1) gelten nicht bei An-sprüchen wegen Verletzung des Lebens, des Körpers oder der Gesundheit sowie bei vorsätzlichen Pflichtverletzungen.

(3) The forfeiture periods according to the above subpara (1) shall not apply to claims concerning injuries of life, body or health as well as to liability for wilful conduct.

 

 

§ 18Schlussbestimmungen

§ 18FINAL PROVISIONS

 

(1) Mündliche Nebenabreden bestehen nicht. Änderungen und Ergänzungen dieses Dienstvertrages, einschließlich dieser Bestimmung, bedürfen zu ihrer Wirksamkeit der Schriftform, sofern sie nicht zwischen den Parteien individuell ausgehandelt sind.

(1) There are no oral side agreements. Amendments and addendums to this Service Agreement, including this provision, must be made in writing in order to be valid, unless they are individually agreed between the Parties.

 

 

 


 

(2) Sollte eine Bestimmung dieses Dienstvertrages ganz oder teilweise unwirksam sein oder werden, so wird hiervon die Wirksamkeit der übrigen Bestimmungen dieses Dienstvertrages nicht berührt. An die Stelle der unwirksamen Bestimmung werden die Parteien die gesetzlich zulässige Bestimmung vereinbaren, die dem mit der unwirksamen Bestimmung Gewollten wirtschaftlich am nächsten kommt. Dasselbe gilt für den Fall einer vertraglichen Lücke.

(2) If any (part of a) provision of this Service Agreement is or becomes invalid or unenforceable, the validity or enforceability of the remaining provisions of this Service Agreement shall not be affected thereby. The Parties will replace the invalid or unenforceable provision by a provision permitted by statutory law which most closely contains the intended economic result of the invalid or unenforceable provision. The same shall apply to a gap in the Service Agreement.

 

(3) Dieser Dienstvertrag ist in deutscher und englischer Fassung ausgefertigt. Im Falle einer Unstimmigkeit oder eines Widerspruchs zwischen der deutschen und der englischen Fassung hat die deutsche Fassung Vorrang.

(3) This Service Agreement is drafted in both German and English. In case of discrepancies or contradictions between the German and the English version, the German version shall prevail.

 

(4) Dieser Dienstvertrag unterliegt deutschem Recht.

(4) This Service Agreement is subject to German law.

 

2016, den / the 13th of July

 

2016, den / the 13th of July

 

FMI Germany GmbH

vertreten durch ihre Alleingesellschafterin / represented by its sole shareholder

 

Foundation Medicine, Inc.

 

 

hier vertreten durch / here represented by

 

 

/s/ Sarah Larson

Sarah Larson

Senior Vice President, Human Resources

 

/s/ Konstantin Fiedler

Konstantin Fiedler

Geschäftsführer / Managing Director

 

 

 

 

 

 


 

EXHIBIT B

Employee Non-Competition, Non-Solicitation, Confidentiality and Assignment Agreement

(See attached)

Non-Competition, Non-Solicitation,
Confidentiality and Assignment Agreement

In consideration and as a condition of my employment or continued employment by Foundation Medicine, Inc. (together with its subsidiaries and affiliates, the “Company”), I hereby agree as follows:

1.

Proprietary Information .  I agree that all information, whether or not in writing, whether or not disclosed before or after I was first employed by the Company, concerning the Company’s business, technology, business relationships or financial affairs that the Company has not released to the general public (collectively, “Proprietary Information”), and all tangible embodiments thereof, are and will be the exclusive property of the Company.  By way of illustration, Proprietary Information may include information or material that has not been made generally available to the public, such as: (a) corporate information, including plans, strategies, methods, policies, resolutions, notes, email correspondence, negotiations or litigation; (b) marketing information, including strategies, methods, customer identities or other information about customers, prospect identities or other information about prospects, or market analyses or projections; (c) financial information, including cost and performance data, debt arrangements, equity structure, investors and holdings, purchasing and sales data and price lists; and (d) operational and technological information, including plans, specifications, manuals, forms, templates, software, designs, methods, procedures, formulas, discoveries, inventions, improvements, biological or chemical materials, concepts and ideas; (e) patient information including patient medical records and all other information relating to patients and (f) personnel information, including personnel lists, reporting or organizational structure, resumes, personnel data, compensation structure, performance evaluations and termination arrangements or documents.  Proprietary Information includes, without limitation, (1) information received in confidence by the Company from its customers or suppliers or other third parties, and (2) all biological or chemical materials and other tangible embodiments of the Proprietary Information.

2. No Unauthorized Disclosure or Use .  I will not, at any time, without the Company’s prior written permission, either during or after my employment, disclose or transfer any Proprietary Information to anyone outside of the Company, or use or permit to be used any Proprietary Information for any purpose other than the performance of my duties as an employee of the Company.  I will cooperate with the Company and use my best efforts to prevent the unauthorized disclosure of all Proprietary Information.  I will deliver to the Company all copies and other tangible embodiments of Proprietary Information in my possession or control upon the earlier of a request by the Company or termination of my employment.

 

 


 

Further, notwithstanding my nondisclosure obligations described in this Section 2, I have been advised that 18 USC Section 1833(b) provides that an individual shall not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that (A) is made: (1) in confidence to a federal, state or local government official, either directly or indirectly, or to an attorney, and (2) solely for the purpose of reporting or investigating a suspected violation of law; or (B) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal.  I have been further advised that an individual who files a lawsuit for retaliation by an employer for reporting a suspected violation of law may disclose the trade secret information in the court proceeding, so long as the individual (i) files any document containing the trade secret under seal; and (ii) does not disclose the trade secret, except pursuant to court order.

3. Rights of Others .  I understand that the Company is now and may hereafter be subject to non-disclosure or confidentiality agreements with third persons that require the Company to protect or refrain from use of proprietary information.  I agree to be bound by the terms of such agreements in the event I have access to such proprietary information.

4. Commitment to Company; Avoidance of Conflict of Interest .  While an employee of the Company, I will devote my full business/professional time and attention to the Company’s business.  I also agree that I will not engage in any other business activity (including service on a Board of Directors) that conflicts with either my time commitment to the Company or my duties to the Company (e.g., being employed by, associated with or having a financial interest in a Company customer, vendor, supplier or any entity engaged in business with Company) or otherwise violates the Code of Conduct, unless I receive prior approval in writing from a representative of the Human Resources Department, in consultation with the Legal Department. I will advise the President of the Company or his or her nominee at such time as any activity of either the Company or another business presents me with a conflict of interest or the appearance of a conflict of interest as an employee of the Company.  I will take whatever action is requested of me by the Company to resolve any conflict or appearance of conflict that it finds to exist.

5. Developments .  I hereby do assign and transfer and, to the extent any such assignment cannot be made at present, will assign and transfer, to the Company and its successors and assigns, all my right, title and interest in and to all Developments (as defined below) that: (a) are created, developed, made, conceived or reduced to practice by me (alone or jointly with others) or under my direction (collectively, “conceived”) during the period of my employment and six (6) months thereafter and that relate to the business of the Company or to products, methods or services being researched, developed, manufactured or sold by the Company; (b) result from tasks assigned to me by the Company; or (c) result from the use of premises, Proprietary Information or personal property (whether tangible or intangible) owned, licensed or leased by the Company (collectively, “Company-Related Developments”), and all related patent rights, trademarks, copyrights and other intellectual property rights in all countries and territories worldwide claiming, covering or otherwise arising from or pertaining to Company-Related Developments (collectively, “Intellectual Property Rights”).  I further agree that “Company-Related Developments” include, without limitation, all Developments that (i) were conceived by me before my employment, (ii) relate to the business of the Company or to products, methods or services being researched, developed, manufactured or sold by the Company, and (iii) were not subject to an obligation to assign to another entity when conceived. I will make full and prompt disclosure to the Company of all Company-Related Developments, as well as all other Developments conceived by me during the period of my employment and six (6) months thereafter.  I acknowledge that all work performed by me as an employee of the Company is on a “work for hire” basis.  I hereby waive all claims to any moral rights or other special rights that I may have or accrue in any Company-Related Developments.

 

 


 

“Developments” mean inventions, discoveries, designs, developments, methods, modifications, improvements, processes, biological or chemical materials, algorithms, databases, computer programs, formulae, techniques, trade secrets, graphics or images, audio or visual works, and other works of authorship.

If, in the course of my employment with the Company, I incorporate a Development conceived by

me before my employment that are not Company-Related Developments (“Prior Inventions”) into a Company product, process or research or development program or other work done for the Company, I hereby grant to the Company a nonexclusive, royalty-free, fully paid-up, irrevocable, perpetual, worldwide license (with the full right to sublicense through multiple tiers) to make, have made, modify, use, offer for sale, import and sell such Prior Invention.  Notwithstanding the foregoing, I will not incorporate, or permit to be incorporated, Prior Inventions in any Company-Related Development without the Company’s prior written consent.

I understand that to the extent this Agreement is required to be construed in accordance with the laws of any state which precludes a requirement in an employee agreement to assign certain classes of inventions made by an employee, this Section 5 will be interpreted not to apply to any invention which a court rules and/or the Company agrees falls within such classes.

To preclude any possible uncertainty, I have set forth on Exhibit A attached hereto a complete list of Developments that I have, alone or jointly with others, conceived, developed or reduced to practice prior to the commencement of my employment with the Company that I consider to be my property or the property of third parties and that I wish to have excluded from the scope of this Agreement (“Prior Inventions”).  If disclosure of any such Prior Invention would cause me to violate any prior confidentiality agreement, I understand that I am not to list such Prior Inventions in Exhibit A but am only to disclose a cursory name for each such invention, a listing of the party(ies) to whom it belongs and the fact that full disclosure as to such inventions has not been made for that reason.  I have also listed on Exhibit A all patents and patent applications in which I am named as an inventor, other than those which have been assigned to the Company (“Other Patent Rights”).

6. Documents and Other Materials .  I will keep and maintain adequate and current records of all Proprietary Information and Company-Related Developments conceived by me, which records will be available to and remain the sole property of the Company at all times.  All files, letters, notes, memoranda, reports, records, data, sketches, drawings, notebooks, layouts, charts, quotations and proposals, specification sheets, program listings, blueprints, models, prototypes, materials or other written, photographic or other tangible material containing or embodying Proprietary Information, whether created by me or others, which come into my custody or possession, are the exclusive property of the Company to be used by me only in the performance of my duties for the Company.  At any time upon the request of the Company, and in any event upon the termination of my employment for any reason, I will deliver to the Company all of the foregoing, and all other materials of any nature pertaining to the Proprietary Information of the Company and to my work, and will not take or keep in my possession any of the foregoing or any copies.  Any property situated on the Company’s premises and owned by the Company, including laboratory space, computers, disks and other storage media, filing cabinets or other work areas, is subject to inspection by the Company at any time with or without notice.

 

 


 

7. Enforcement of Intellectual Property Rights .  I will cooperate fully with the Company, both during and after my employment with the Company, with respect to the procurement, maintenance and enforcement of Intellectual Property Rights, as well as all other patent rights, trademarks, copyrights and other intellectual property rights in all countries and territories worldwide owned by or licensed to the Company.  I will sign, both during and after the term of this Agreement, all papers, including copyright applications, patent applications, declarations, oaths, assignments of priority rights, and powers of attorney, which the Company may deem necessary or desirable in order to protect its rights and interests in any Company- Related Development or Intellectual Property Rights.  If the Company is unable, after reasonable effort, to secure my signature on any such papers, I hereby irrevocably designate and appoint each officer of the Company as my agent and attorney-in-fact to execute any such papers on my behalf, and to take any and all actions as the Company may deem necessary or desirable in order to protect its rights and interests in the same.

8. Non-Competition and Non-Solicitation .  I acknowledge and agree that the Company has invested substantial time, money and resources in the development of its Proprietary Information, including as it pertains to its customers, clients, and collaborators.  I further acknowledge that during the course of my employment, I will have access to and may use and work with such Proprietary Information that pertains to the customers, clients, and collaborators of the Company, and I agree that any Proprietary Information associated with any customer, client, or collaborator belongs exclusively to the Company.

In order to protect the Company’s Proprietary Information and good will, during my employment and for a period of one (1) year following the termination of my employment for any reason (the “Restricted Period”) I will not directly or indirectly, whether as owner, partner, shareholder, director, consultant, agent, employee, co-venturer or otherwise, engage, participate or invest in any business activity anywhere in the Restricted Territory (defined below) that develops, manufactures or markets any products, or performs any services, that are otherwise competitive with or similar to the products or services of the Company, or products or services that the Company has under development or that are the subject of active planning at any time during my employment; provided that this will not prohibit any possible investment in publicly traded stock of a company representing less than one percent of the stock of such company.  For purposes of this Agreement, the “Restricted Territory” shall mean each and every country, province, state, city or other political subdivision in which the Company or any of its affiliates carries on or actively plans to carry on any activities of the Company’s business (including, without limitation, sales and marketing activities).

In addition, during my employment and the Restricted Period, I will not, directly or indirectly, in any manner, other than for the benefit of the Company, (a) call upon, solicit, divert or take away any of the customers, business or prospective customers of the Company or any of its suppliers, and/or (b) solicit, entice or attempt to persuade any other employee or consultant of the Company to leave the services of the Company for any reason or otherwise participate in or facilitate the hire, directly or through another entity, of any person who is employed or engaged by the Company or who was employed or engaged by the Company within two (2) months of any attempt to hire such person.

I acknowledge and agree that if I violate any of the provisions of this Section 8, the running of the Restricted Period will be extended by the time during which I engage in such violation(s).

 

 


 

9. Government Contracts .  I acknowledge that the Company may have from time to time agreements with other persons or with the United States Government or its agencies that impose obligations or restrictions on the Company regarding inventions made during the course of work under such agreements or regarding the confidential nature of such work.  I agree to comply with any such obligations or restrictions upon the direction of the Company.  In addition to the rights assigned under Section 5, I also assign to the Company (or any of its nominees) all rights which I have or acquired in any Developments, full title to which is required to be in the United States under any contract between the Company and the United States or any of its agencies.

10. Prior Agreements .  I hereby represent that, except as I have fully disclosed previously in writing to the Company, I am not bound by the terms of any agreement with any previous employer or other party to refrain from using or disclosing any trade secret or confidential or proprietary information in the course of my employment with the Company or to refrain from competing, directly or indirectly, with the business of such previous employer or any other party.  I further represent that my performance of all the terms of this Agreement as an employee of the Company does not and will not breach any agreement to keep in confidence proprietary information, knowledge or data acquired by me in confidence or in trust prior to my employment with the Company.  I will not disclose to the Company or induce the Company to use any confidential or proprietary information or material belonging to any previous employer or others.

11. Remedies Upon Breach .  I understand that the restrictions contained in this Agreement are necessary for the protection of the business and goodwill of the Company and I consider them to be reasonable for such purpose.  Any breach of this Agreement is likely to cause the Company substantial and irrevocable damage and therefore, in the event of such breach, the Company, in addition to such other remedies that may be available, will be entitled to specific performance and other injunctive relief without the posting of a bond.  If I violate this Agreement, in addition to all other remedies available to the Company at law, in equity, and under contract, I agree that I am obligated to pay all the Company’s costs of enforcement of this Agreement, including attorneys’ fees and expenses.

12. Publications .  I will obtain the Company’s written approval before publishing or submitting for publication any material that relates to my work at the Company and/or incorporates any Proprietary Information.

13. Use of Voice, Image and Likeness .  I give the Company permission to use any and all of my voice, image and likeness, with or without using my name, in connection with the products and/or services of the Company, for the purposes of advertising and promoting such products and/or services and/or the Company, and/or for other purposes deemed appropriate by the Company in its reasonable discretion, except to the extent expressly prohibited by law.

14. No Employment Obligation .  I understand that this Agreement does not create an obligation on the Company or any other person to continue my employment.  I acknowledge that, unless otherwise agreed in a formal written employment agreement signed on behalf of the Company by an authorized officer, my employment with the Company is at will and therefore may be terminated by the Company or me at any time and for any reason.

 

 


 

15. Corporate Compliance .  I agree that I will abide by all policies and procedures that the Company may have in effect from time to time, including without limitation, the Company’s Code of Conduct and corporate compliance program.  I further acknowledge that failure to abide by policies and procedures may result in discipline, including immediate termination of my employment.  Nothing herein limits my at-will employment with the Company, pursuant to Section 14 above.

16. Survival and Assignment by the Company .  I understand that my obligations under this Agreement will continue in accordance with its express terms regardless of any changes in my title, position, duties, salary, compensation or benefits or other terms and conditions of employment.  I further understand that my obligations under this Agreement will continue following the termination of my employment regardless of the manner of such termination and will be binding upon my heirs, executors and administrators.  The Company will have the right to assign this Agreement to its affiliates, successors and assigns for no additional consideration.  I expressly consent to be bound by the provisions of this Agreement for the benefit of the Company or any parent, subsidiary or affiliate to whose employ I may be transferred without the necessity that this Agreement be resigned at the time of such transfer.  I acknowledge that the term “the Company,” as used in this Agreement, shall also mean any such successor entity as the context requires.

17. Disclosure to Future Employers .  I will provide a copy of this Agreement to any prospective employer, partner or co-venturer prior to entering into an employment, partnership or other business relationship with such person or entity.

18. Exit Interview .  If and when I depart from the Company, I may be required to attend an exit interview and sign an “Employee Exit Acknowledgement” to reaffirm my acceptance and acknowledgement of the obligations set forth in this Agreement.  During the Restricted Period following termination of my employment, I will notify the Company of any change in my address and of each subsequent employment or business activity, including the name and address of my employer or other post-Company employment plans and the nature of my activities.

19. Severability .  In case any provisions (or portions thereof) contained in this Agreement will, for any reason, be held invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability will not affect the other provisions of this Agreement, and this Agreement will be construed as if such invalid, illegal or unenforceable provision had never been contained herein.  If, moreover, any one or more of the provisions contained in this Agreement will for any reason be held to be excessively broad as to duration, geographical scope, activity or subject, it will be construed by limiting and reducing it, so as to be enforceable to the extent compatible with the applicable law as it will then appear.

20. Protected Disclosures .  I understand that nothing contained in this Agreement limits my ability to communicate with any federal, state or local governmental agency or commission, including to provide documents or other information, without notice to the Company.  I also understand that nothing in this Agreement limits my ability to share compensation information concerning myself or others, except that this does not permit me to disclose compensation information concerning others that I obtain because my job responsibilities require or allow access to such information.

 

 


 

21. Entire Agreement .  This Agreement constitutes the entire and only agreement between the Company and me respecting the subject matter hereof, and supersedes all prior agreements and understandings, oral or written, between us concerning such subject matter; provided, however, that this Agreement shall supplement, and shall not limit or be limited by, any other agreement I have with, or obligation I have to, the Company regarding noncompetition, nonsolicitation, confidentiality, assignment of inventions, and related covenants.  No modification, amendment, waiver or termination of this Agreement or of any provision hereof will be binding unless made in writing and signed by an authorized officer of the Company.  Failure of the Company to insist upon strict compliance with any of the terms, covenants or conditions hereof will not be deemed a waiver of such terms, covenants or conditions.  In the event of any inconsistency between this Agreement and any other contract between the Company and me,    the provisions of this Agreement will prevail.

22. Interpretation, Governing Law, Forum Selection Clause .  This Agreement and any claims arising out of this Agreement (or any other claims arising out of the relationship between the parties) shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts and shall in all respects be interpreted, enforced and governed under the internal and domestic laws of such state, without giving effect to the principles of conflicts of laws of such state.  Any claims or legal actions by one party against the other shall be commenced and maintained in any state or federal court located in the Commonwealth of Massachusetts, and I hereby submit to the jurisdiction and venue of any such court.  As used in this Agreement, “including” means “including but not limited to.”

23. Execution of Agreement .  This Agreement shall be binding and effective upon the undersigned’s signature.

BY SIGNING BELOW, I CERTIFY THAT I HAVE READ THIS AGREEMENT CAREFULLY
AND AM SATISFIED THAT I UNDERSTAND IT COMPLETELY.

IN WITNESS WHEREOF, the undersigned has executed this agreement as a sealed
instrument as of the date set forth below.

Signed: /s/ Konstantin Fiedler

(Employee’s full name)

Type or print name: Konstantin Fiedler

Date: April 30, 2018

 

 

 

 


 

EXHIBIT A

TO: Foundation Medicine, Inc.

FROM:

DATE:

SUBJECT: Prior Inventions

The following is a complete list of all inventions or improvements relevant to the subject matter of my employment by the Company that have been made or conceived or first reduced to practice by me alone or jointly with others prior to my engagement by the Company:

 

No inventions or improvements

 

See below:

 

 

 

 

 

 

 

 

 

 

 

Additional sheets attached

The following is a list of all patents, patent applications and other patent rights that I have invented:

 

None

 

See below:

 

 

 

 

 

 

 

 

 

 

 

Exhibit 10.4

 

 

 

September 12, 2016

Melanie Nallicheri

Re: Employment with Foundation Medicine, Inc.

Dear Melanie:

On behalf of Foundation Medicine, Inc. (“ Foundation Medicine ” or “ the Company ”), I am very pleased to offer you the position of Chief Business Officer and Head, Biopharma.

The terms of your position with the Company are as set forth below in this letter agreement (“Agreement”):

 

1.

Position .  Your position at the Company will be Chief Business Officer and Head, Biopharma, reporting to Steven J. Kafka, Ph.D., President and Chief Operating Officer. You will be a member of the Company’s Senior Management Team. In addition to performing duties and responsibilities associated with the position above, from time-to-time the Company may assign you other duties and responsibilities consistent with such position.

 

2.

Start Date . You will begin your employment with the Company no later than September 29, 2016.

 

3.

Compensation and Related Matters .

a. Base Salary . You will be paid on a salary basis at a rate of $13,846.15 per bi-weekly pay period, representing payment for all hours worked by you for Foundation Medicine, equivalent to an annualized base salary of approximately $360,000. The base salary will be paid in accordance with Foundation Medicine’s standard payroll practices and subject to customary deductions and withholdings as required by law. You will be eligible to participate in annual merit salary reviews in accordance with the Company’s


compensation practices. To be eligible for a merit increase, you must be employed by September 30 of the previous year. This position is exempt, so you will not be eligible
for overtime pay.

b. Performance Incentive .  You will be eligible to participate in the Company’s annual performance incentive program, subject to its terms and conditions and at the discretion of the Company’s Board of Directors, with the potential to earn an incentive equivalent to a target of up to 40% of your then annual base salary. The performance incentive is based upon achievement of Company performance, department performance, and individual performance. The Company may also make adjustments in the targeted amount of your annual performance incentive in its discretion. If you begin employment with the Company between January 1 and September 30 th , you will be eligible to earn a pro-rated performance incentive based on the length of time that you have been employed with the Company during this calendar year. If you begin employment between October 1 and December 31 st , you will not be eligible to participate in the incentive program until the following calendar year. You must be employed by the Company at the time a performance incentive is paid to earn any part of an incentive.

c. Expenses . The Company will reimburse your reasonable out-of-pocket travel expenses and other expenses related to your work in accordance with the Company’s expense reimbursement policy.

d. Long-Term Incentives :  As an incentive for you to join Foundation Medicine and to share in the long-term growth of Foundation Medicine, you will be eligible to participate in a long-term incentive award program with two separate but complementary awards: a cash incentive award, and an equity incentive award. Both of these awards will vest over a four-year period.

Cash award :  Subject to approval by the Board of Directors (or committee thereof) or the Chief Executive of the Company, as may be required by the Company’s applicable governance rules, you will be granted a cash award of $150,000 (“Cash Award”) effective on the first day of the calendar quarter following your date of hire (“Grant Date”). Based on your date of hire, the Grant Date of the Cash Award will be one of January 1, April 1, July 1 or October 1. The Cash Award will vest over a four-year period as follows: 25% will vest on the first anniversary of the Grant Date, and an additional 12.5% will vest every six months thereafter until 100% of the Cash Award has vested. As a condition to receiving each Cash Award payment, you must be an employee of Foundation Medicine as of the relevant vesting date and without any prior interruption of service. The Cash Award will be subject to the provisions of Foundation Medicine’s then-current long term incentive cash award plan, as may be amended from time to time. Each Cash Award will be subject to customary deductions and tax withholdings as required by law.

Equity award :  Subject to approval by the Board of Directors (or a committee thereof) or the Chief Executive Officer of the Company, as may be required by the Company’s applicable governance rules, you will be granted an equity award of Restricted Stock Units (RSUs) with an aggregate value of $1,500,000 (“Equity


Award”). The number of RSUs to be granted will be calculated based on the 30-day average closing price of Foundation Medicine common stock ending on a date that is within five business days prior to the grant date. The effective date for the grant will be the first day of the calendar quarter following your date of hire (“Equity Grant Date”).  Accordingly, based on your date of hire, the Equity Grant Date of the Equity

Award will be one of January 1, April 1, July 1 or October 1. The Equity Award will vest over a four-year period as follows: 25% will vest on the first anniversary of the Equity Grant Date, and an additional 6.25% will vest on the first day of each subsequent quarter thereafter until 100% of the RSUs have vested. As a condition to receiving each Equity Award, you must be an employee of Foundation Medicine as of the relevant vesting date and without any prior interruption of service. The Equity Award will be governed by a restricted stock unit award agreement in the standard form approved by Foundation Medicine’s Board of Directors and shareholders, and will be subject to the provisions of Foundation Medicine’s then-current stock incentive plan (together with any other incentive equity plan(s), as may be amended from time to time, any associated award agreements, the “Equity Documents”).

e. Living Expense Assistance and Relocation.   The Company requires that as a condition of employment, you relocate to Massachusetts.  The Company acknowledges and agrees that you will commute from your home in California to the Company’s offices in Cambridge on a weekly basis, in accordance to a schedule agreed to by the COO (the “Transition Period”), and you will average 80% of your time in Massachusetts for not more than 12 months, the specifics of which will fluctuate based on business needs but generally are anticipated to include at least Tuesday through Thursday weekly.The Company acknowledges and agrees that time you spend traveling to and from Cambridge each week during the Transition Period (generally anticipated to be on Mondays and Thursdays) will be included within the 80% average.  Changes and exceptions to this 80% requirement may be made by mutual agreement with the President & COO; however, if the requirement is not being met on a routine basis (based on the reasonable judgment of the President & COO) you will be given notice of such and provided a period of 30 days to remedy.

During the Transition Period, the Company will provide you with living expense allowance, payable only in the form of reimbursement and not as an addition to your salary, on a monthly basis at the equivalent of $35,000 annually (the “Living Expense Allowance”).  This Living Expense Allowance will reimburse you for living expenses, customary costs and food expenses (to the extent such food expenses are not otherwise reimbursable as a business expense under the Company’s business expense policy), in each instance as incurred in the Cambridge area (“Living Expenses”).  Subject to your right to aggregate the Living Expense Allowance with the Relocation Allowance as described below, the costs of any Living Expenses under or over the Living Expense Allowance shall not affect the amount of Living Expense Allowance eligible for reimbursement, and you shall not be entitled to any supplemental payment if the actual Living Expenses is less than the Living Expense Allowance.  The Company will also reimburse or directly pay for your reasonable travel expenses incurred in commuting between California and Cambridge, Massachusetts (“Commuting Expenses”).


In the event that you do not relocate to Massachusetts (or the commutable surrounding areas) within 12 months, or do not renegotiate, at management’s discretion, the terms of your agreement, the Company will no longer be required to provide you with Living Expense Assistance.

If you relocate to the Cambridge area prior to the end of the Transition Period, the Company will reimburse you for reasonable relocation expenses (“Relocation Expenses”) incurred by you up to $75,000.00, subject to prior approval by the COO and the Senior Vice President, Human Resources (“Relocation Allowance”).  Reimbursable Relocation Expenses shall include costs or expenses incurred by you in connection with having to change your family’s residence from California to Massachusetts, such as, by way of example only, moving expenses, transaction costs incurred in connection with the purchase of a new home, or other costs incurred as a result of the relocation.  If you resign from the Company without Good Reason within 18 months after the receipt of the relocation assistance, you will reimburse the Company for the entirety of the amount of the Relocation Allowance paid to you within thirty (30) days of your last day of employment, in a check made payable to the Company.

The aggregate value of the Living Expense Allowance and the Relocation Allowance is acknowledged to be $110,000, and you may reallocate expenses between these categories provided that the Company’s total payment shall not exceed this aggregate amount.

The Company will determine in its reasonable judgment what, if any, of your Living Expenses, Commuting Expenses and Relocation Expenses paid for or reimbursed by the Company are taxable to you in accordance with applicable law and will comply with associated withholding and tax reporting obligations.  To the extent certain of these Living Expenses, Commuting Expenses and Relocation Expenses are deemed taxable by the IRS in a given year, the Company will provide you with a tax gross-up payment such that after payment of taxes (federal, state and employment) on such amount, there remains a balance sufficient to pay the taxes (federal, state and employment) on the amount of your taxable reimbursable Commuting Expenses and Living Expenses.  The Company will make such tax gross-up payment promptly but in no event later than the end of the calendar year in which you remit the related taxes.


f. Other Benefits .  As a regular, full-time employee, you will be eligible to participate in the employee benefit program that Foundation Medicine offers to its employees in comparable positions, which currently include Health, Dental, Life and Disability Insurance, matching 401(k) Plan, and Sick Time, subject to plan terms and generally applicable Foundation Medicine policies.  You will be also be entitled to accrue up to fifteen (15) days of vacation each calendar year and to such other holidays as Foundation Medicine recognizes for employees having comparable responsibilities and duties.  For any calendar year in which you are employed with the Company for only a portion of such year, the vacation time will be pro-rated.  Descriptions of the Company’s benefits will be available upon request.  The Company retains the right to amend, modify, or cancel any benefits program.  Where a particular benefit is subject to a formal plan (for example, medical insurance or 401(k)), eligibility to participate in and receive any particular benefit is governed solely by the applicable plan document.

 

4.

At-Will Employment .  Your employment at all times shall remain “at will,” meaning that either you or the Company may terminate the employment relationship at any time, for any lawful reason, with or without cause.

 

5.

Non-Competition, Non-Solicitation, Confidentiality and Assignment Agreement .  As part of your employment with Foundation Medicine, you will be exposed to, and provided with, valuable confidential and/or trade secret information concerning Foundation Medicine and its present and future business plans and operations.  As a result, in order to protect Foundation Medicine’s substantial investment of time and money in the creation and maintaining of its confidential information and good-will with its customers, clients, and collaborators, your offer of employment is contingent upon your signing the Company’s Employee Non-Competition, Non-Solicitation, Confidentiality and Assignment Agreement (the “ Restrictive Covenant Agreement ”), a copy of which is attached to this Offer as Exhibit A and your continued willingness to abide by its terms.

By the same token, Foundation Medicine expects you to abide by and honor the terms of any agreements you may have with your present or prior employers.  By signing below, you represent that you are not subject to any agreements which might restrict your conduct at the Company, and that you understand that if you become aware at any time during your employment with the Company that you are subject to any agreements which might restrict your activities at Foundation Medicine, you are required to immediately inform the Company’s Senior Vice President, Human Resources of the existence of such agreements.  In the event of an irresolvable conflict, your employment by Foundation Medicine could be subject to termination and such termination would be deemed a for “Cause” termination for purposes of this Agreement and the Equity Documents.

Also, just as Foundation Medicine regards the protection of our confidential information as a matter of great importance, we also respect that you may have an obligation to your present and/or prior employers to safeguard the confidential information of those companies.  Foundation Medicine respects these obligations, and expects you to honor them as well.  To that end, we expect that you have not taken any documents or other confidential information from your employer.  Further, we want to make it perfectly clear you should not bring with you to Foundation Medicine, or use in the performance of your


duties for our Company, any proprietary business or technical information, materials or documents of a former employer, or otherwise disclose or use any former employer’s confidential information.

 

6.

Work Authorization .  This offer of employment is contingent on you being legally authorized to work in the United States, and you will need to complete an 1-9 Employment Verification Form no later than your first day of work.

 

7.

Termination of Employment.

a. Severance Payments .  Without otherwise limiting the “at will” nature of your employment if: (i) your employment is terminated by the Company without Cause at any time, or (ii) within twelve (12) months following a Change in Control you terminate your employment with the Company for Good Reason in accordance with the Good Reason Process, and, in either event, you enter into, do not revoke, and comply with a Release, the Company shall pay or provide you with: (a) Salary Continuation for twelve (12) months following your termination date (the “ Salary Continuation Period ”); (b) Health Care Continuation during the Salary Continuation Period; and (c) a Performance Incentive equal to your current year target annual performance incentive amount, prorated based on the length of time that you have been employed with the Company during the calendar year in which your employment is terminated (collectively, the “ Severance Payments ”); provided and notwithstanding the foregoing, if your employment is terminated in connection with a Change in Control and you immediately become reemployed by any direct or indirect successor to the business or assets of the Company, the termination of your employment upon the Change in Control shall not be considered a Termination without Cause for purposes of this Agreement.

b. Equity Acceleration .  In the event that you become entitled to Severance Payments within eighteen (18) months following a Change in Control, and you enter into, do not revoke, and comply with a Release, then all outstanding unvested equity-based compensation awards that have been granted acceleration rights and were granted to you under the Equity Documents prior to the Change of Control shall become exercisable and vested in full, and all restrictions thereon shall lapse, notwithstanding any vesting schedule or other provisions to the contrary in the agreements evidencing such awards or in the underlying equity plan, and the Company and you hereby agree that any agreements covering such awards are hereby, and will be deemed to be, amended to give effect to this provision.

c. Non-Eligibility for Severance Payments or Equity Award Acceleration .  For the avoidance of doubt, you and the Company acknowledge that if your employment is terminated: (i) by the Company for Cause, (ii) by you without Good Reason, (iii) by you with Good Reason following a Change in Control but without complying with the Good Reason Process, or (iv) as a result of your death or disability, then, as a result of such termination, (w) you shall not be entitled to Severance Payments, (x) you shall be entitled to receive only base salary earned plus accrued but unused vacation pay through the date of termination, (y) the unvested portion of your Equity Awards will not accelerate and (z) your Equity Awards shall expire or be forfeited in accordance with the terms of the Equity Documents.


 

8.

Definitions .  For purposes of this Agreement, the following terms shall have the following meanings:

Company ” means Foundation Medicine, Inc., and its successors and assigns.

Cause ” means one or more of the following events: (i) your conviction of, or the entry of a pleading of guilty or nolo contendere to, any crime involving (A) fraud or embezzlement, or (B) any felony; (ii) your willful failure to perform (other than by reason of disability), or gross negligence in the performance of, your duties and responsibilities as set forth in your job description; (iii) a material breach by you of any provision of this Agreement, the Restrictive Covenant Agreement, or any of the other agreements you have with the Company; or (iv) material fraudulent conduct by you with respect to the Company.  Notwithstanding the foregoing, “cause” shall not be deemed a basis for the termination of your employment pursuant to clauses (ii) or (iii) of this paragraph unless (a) the Company determines that your past or anticipated activities have or will not cause imminent and material damage to the Company, (b) the Company provides you with written notice specifying in reasonable detail the alleged grounds for terminating your employment for “cause,” (c) you are given not less than thirty days after the receipt of such notice to cure the identified issues, to the extent such cure is reasonably practicable, and (d) the Company determines, in its reasonable determination, that the identified issues have not been remedied.

Change in Control ” shall mean:

a. any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “Act”) (other than the Company, any of its subsidiaries, or any trustee, fiduciary or other person or entity holding securities under any employee benefit plan or trust of the Company or any of its subsidiaries), together with all “affiliates” and “associates” (as such terms are defined in Rule 12b-2 under the Act) of such person, shall become the “beneficial owner” (as such term is defined in Rule 13d-3 under the Act), directly or indirectly, of securities of the Company representing 50 percent or more of the combined voting power of the Company’s then outstanding securities having the right to vote in an election of the Board of Directors (“ Voting Securities ”) (in such case other than as a result of an acquisition of securities directly from the Company); or

b. the date when a majority of the members of the Board of Directors of the Company is replaced by individuals who, prior to their election, or nomination for election by the Company’s shareholders, were not approved by a majority of the members of the Board of Directors in existence on the date immediately prior to such election, appointment or nomination (excluding any individuals nominated by any member of the Investor Group (as defined in that certain Investor Rights Agreement, dated as of January 11, 2015 (as amended from time to time), by and among the Company, Roche Holdings, Inc. and certain other stockholders of the Company named therein (the Investor Rights Agreement ”) following the occurrence of a Material Breach (as defined in the Investor Rights Agreement); or


c. the consummation of (A) any consolidation or merger of the Company where the stockholders of the Company, immediately prior to the consolidation or merger, would not, immediately after the consolidation or merger, beneficially own (as such term is defined in Rule 13d-3 under the Act), directly or indirectly, shares representing in the aggregate more than 50 percent of the voting shares of the Company issuing cash or securities in the consolidation or merger (or of its ultimate parent corporation, if any), or (B) any sale or other transfer (in one transaction or a series of transactions contemplated or arranged by any party as a single plan) of all or substantially all of the assets of the Company; or

d. the consummation by any member of the Investor Group of any tender or exchange offer, merger, consolidation, business combination or other similar transaction involving the Company that results in the Investor Group collectively owning all of the outstanding Voting Securities of the Company.

Notwithstanding the foregoing, a “Change in Control” shall not be deemed to have occurred for purposes of the foregoing clause (a) (i) solely as the result of an acquisition of securities by the Company which, by reducing the number of shares of Voting Securities outstanding, increases the proportionate number of Voting Securities beneficially owned by any person to 50 percent or more of the combined voting power of all of the then outstanding Voting Securities; provided, however, that if any person referred to in this sentence shall thereafter become the beneficial owner of any additional shares of Voting Securities (other than pursuant to a stock split, stock dividend, or similar transaction or as a result of an acquisition of securities directly from the Company) and immediately thereafter beneficially owns 50 percent or more of the combined voting power of all of the then outstanding Voting Securities, then a “Change in Control” shall be deemed to have occurred for purposes of the foregoing clause (a); or (ii) as a result of Roche’s acquisition of Voting Securities as provided under Section 4.03(a) and/or 4.04(b) of the Investor Rights Agreement.

Equity Award ” means all incentive stock options, non-statutory stock options, shares of restricted stock, restricted stock units or other incentive equity awards in respect of shares of the Company’s equity securities that have been or will be granted to you by the Company.

Good Reason ” means that you have complied with the “Good Reason Process” (hereinafter defined) following the occurrence of any of the following events in connection with a Change of Control:

(i) a material diminution in your responsibilities, your reporting relationship to your supervisor, or your authority or duties;

(ii) a material diminution in your Base Salary except for across-the-board salary reductions based on the Company’s financial performance similarly affecting all or substantially all senior management employees of the Company;


(iii) your work location is located more than fifty (50) miles from the Company’s office location at which you were principally working as of the effective date of the Change in Control; or

(iv) the material breach of this Agreement by the Company.

Good Reason Process ” means that (i) you reasonably determine that a Good Reason condition has occurred, (ii) you notify the Company in writing of the first occurrence of the Good Reason condition within sixty (60) days of the first occurrence of such condition, (iii) you cooperate in good faith with the Company’s efforts, for a period of not less than thirty (30) days following such notice (the “ Cure Period ”), to remedy the Good Reason condition, (iv) notwithstanding such efforts a material element of at least one Good Reason condition continues to exist, and (v) you terminate your employment within sixty (60) days after the end of the Cure Period.  If the Company fully cures the Good Reason condition during the Cure Period, Good Reason shall be deemed not to have occurred.  The Company’s success at curing a Good Reason condition shall not bar or preclude your right to notify the Company of the occurrence of another Good Reason condition and to proceed with the Good Reason Process.

Health Care Continuation ” means that if you are participating in the Company’s group health plan immediately prior to the date of your termination, then subject to your timely election and eligibility for benefits under the law known as COBRA, and any law that is the successor to COBRA, the Company shall continue to pay the employer portion of your health benefits until the earlier of the end of the Salary Continuation Period and the date you become re-employed or otherwise ineligible for COBRA.

Release ” shall mean a separation agreement in a form prescribed by the Company that includes, without limitation, (i) a general release of claims and non-disparagement covenant, both in favor of the Company and related persons and entities, (ii)

reaffirmation of your obligations under the Employee Agreement, the terms of which will be incorporated by reference into the Release, and (iii) a provision stating that, if you breach any of the material provisions of Release, in addition to all other rights and remedies, the Company shall have the right to receive reimbursement for, or to terminate or cease payment of, Severance Payments paid or payable to you.

Salary Continuation ” means that the Company shall continue to pay you your base salary at the rate in effect on the date of termination during the Salary Continuation Period.  The first payment of Salary Continuation shall be paid within sixty (60) days after the date of termination and shall be made on the Company’s regular payroll dates; provided, however, that if the sixty (60) day period begins in one calendar year and ends in a second calendar year, the first payment of Salary Continuation shall be paid in the second calendar year.  In the event you miss one or more regular payroll periods between the date of termination and the first Salary Continuation payment, the first Salary Continuation payment shall include a “catch up” payment of accrued but unpaid Salary Continuation payments.


 

9.

Section 409A Compliance .  To the extent that any Severance Payments or other benefits to you constitute “non-qualified deferred compensation” under Section 409A of the Internal Revenue Code of 1986 (as amended or replaced) (the Code ), then such Severance Payments or benefits shall begin only upon or after the date of your “separation from service” (within the meaning of Section 409A of the Code), which may occur on or after the date of the termination of your employment.  Neither the Company nor you shall have the right to accelerate or defer the delivery of any such payments except to the extent specifically permitted or required by Section 409A.  Anything to the contrary notwithstanding, if at the time of your separation from service within the meaning of Section 409A of the Code, the Company determines that you are a “specified employee” within the meaning of Section 409A(a)(2)(B)(i) of the Code, then to the extent any payment or benefit that you become entitled to under this Agreement on account of your separation from service would be considered deferred compensation otherwise subject to the twenty percent (20%) additional tax imposed pursuant to Section 409A(a) of the Code as a result of the application of Section 409A(a)(2)(B)(i) of the Code, such payment shall not be payable and such benefit shall not be provided until the date that is the earlier of (i) six (6) months and one day after your separation from service, or (ii) the your death.  If any such delayed cash payment is otherwise payable on an installment basis, the first payment shall include a catch-up payment covering amounts that would otherwise have been paid during the six (6)-month period but for the application of this provision, and the balance of the installments shall be payable in accordance with their original schedule. The determination of whether and when your “separation from service” from the Company has occurred shall be made in a manner consistent with, and based on the presumptions set forth in, Treasury Regulation Section 1.409A-l(h).  Solely for purposes of this Section, “Company” shall include all persons with whom the Company would be considered a single employer under Sections 414(b) and 414(c) of the Code.

All in-kind benefits provided and expenses eligible for reimbursement under this Agreement shall be provided by the Company or incurred by you during the time periods set forth in this Agreement.  All reimbursements shall be paid as soon as administratively practicable, but in no event shall any reimbursement be paid after the last day of the taxable year following the taxable year in which the expense was incurred.  The amount of in-kind benefits provided or reimbursable expenses incurred in one taxable year shall not affect the in-kind benefits to be provided or the expenses eligible for reimbursement in any other taxable year (except for any lifetime or other aggregate limitation applicable to medical expenses).  Such right to reimbursement or in-kind benefits is not subject to liquidation or exchange for another benefit.

The parties intend that this Agreement will be administered in accordance with Section 409A.  To the extent that any provision of this Agreement is ambiguous as to its compliance with Section 409A, the provision shall be read in such a manner so that all payments hereunder comply with Section 409A.  Each payment pursuant to this Agreement is intended to constitute a separate payment for purposes of Treasury Regulation Section 1,409A-2(b)(2).  The parties agree that this Agreement may be amended, as reasonably requested by either party, and as may be necessary to fully comply with Section 409A and all related rules and regulations in order to preserve the payments and benefits provided hereunder without additional cost to either party.  The


Company shall have no liability to you or to any other person if any provisions of this Agreement that are intended to be exempt from or compliant with Section 409A are not so exempt or compliant.

 

10.

Section 280G Limitation .

(a) Anything in this Agreement to the contrary notwithstanding, in the event that the amount of any compensation, payment or distribution by the Company to or for the benefit of you, whether paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise, calculated in a manner consistent with Section 280G of the Internal Revenue Code of 1986, as amended (the “Code”) and the applicable regulations thereunder (the “Severance Payments”), would be subject to the excise tax imposed by Section 4999 of the Code, the following provisions shall apply:

(i) If the Severance Payments, reduced by the sum of (1) the Excise Tax and (2) the total of the Federal, state, and local income and employment taxes payable by the Executive on the amount of the Severance Payments which are in excess of the Threshold Amount, are greater than or equal to the Threshold Amount, you shall be entitled to the full benefits payable under this Agreement.

(ii) If the Threshold Amount is less than (x) the Severance Payments, but greater than (y) the Severance Payments reduced by the sum of (1) the Excise Tax and (2) the total of the Federal, state, and local income and employment taxes on the amount of the Severance Payments which are in excess of the Threshold Amount, then the Severance Payments shall be reduced (but not below zero) to the extent necessary so that the sum of all Severance Payments shall not exceed the Threshold Amount.  In such event, the Severance Payments shall be reduced in the following order: (1) cash payments not subject to Section 409A of the Code; (2) cash payments subject to Section 409A of the Code; (3) equity-based payments and acceleration; and (4) non-cash forms of benefits.  To the extent any payment is to be made over time (e.g., in installments, etc.), then the payments shall be reduced in reverse chronological order.

(b) For the purposes of this Section 9, “Threshold Amount” shall mean three times the your “base amount” within the meaning of Section 280G(b)(3) of the Code and the regulations promulgated thereunder less one dollar ($1.00); and “Excise Tax” shall mean the excise tax imposed by Section 4999 of the Code, and any interest or penalties incurred by the Executive with respect to such excise tax.

(c) The determination as to which of the alternative provisions of Section 9(a) shall apply to you shall be made by a nationally recognized accounting firm selected by the Company (the “Accounting Firm”), which shall provide detailed supporting calculations both to the Company and you within 15 business days of the termination date, if applicable, or at such earlier time as is reasonably requested by the Company or you.  For purposes of determining which of the alternative provisions of Section 9(a) shall apply, you shall be deemed to pay federal income taxes at the highest marginal rate of federal income taxation applicable to individuals for the calendar year in which the determination is to be made, and state and local income taxes at the highest marginal


rates of individual taxation in the state and locality of the your residence on the date of termination, net of the maximum reduction in federal income taxes which could be obtained from deduction of such state and local taxes.  Any determination by the Accounting Firm shall be binding upon the Company and you.

 

11.

Litigation and Regulatory Cooperation .  During and after your employment, you agree to cooperate fully with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while you were employed by the Company.  Your full cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times.  During and after your employment, you also agree to cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while you were employed by the Company.  The Company shall reimburse you for any reasonable out-of-pocket expenses incurred in connection with your performance of obligations pursuant to this Section.

 

12.

Relief .  If you breach, or propose to breach, any portion of this Agreement, including any of the Restrictive Covenants, or, if applicable, the Release Agreement, the Company shall be entitled, in addition to all other remedies that it may have, to an injunction or other appropriate equitable relief to restrain any such breach, and, if applicable, the Company shall have the right to suspend or terminate the payments, benefits and or accelerated vesting pursuant to Section 6.  Such suspension or termination shall not limit the Company’s other options with respect to relief for such breach and shall not relieve you of duties under this Agreement, the Restrictive Covenants or the Release Agreement.

 

13.

Miscellaneous .

a. This Agreement, including the Restrictive Covenant Agreement and the Equity Documents constitute the entire agreement as to your employment relationship with Foundation Medicine and will supersede any prior agreements or understandings, whether in writing or oral.

b. This Agreement shall remain in effect if you are transferred, promoted, or reassigned to work in functions other than your current functions at the Company.  Your obligations under this Agreement shall survive the termination of your employment with the Company regardless of the manner or the reasons for such termination.

c. This Agreement may not be modified or amended unless agreed to in writing by you and an expressly authorized representative of the Company.


d. No waiver of any provision hereof shall be effective unless made in writing and signed by the waiving party.  The failure of any party to require the performance of any term or obligation of this Agreement, or the waiver by any party of any breach of this Agreement, shall not prevent any subsequent enforcement of such term or obligation or be deemed a waiver of any subsequent breach.

e. All forms of compensation referred to in this Agreement are subject to reduction to reflect applicable withholding and payroll taxes and other deductions required by law.

f. This Agreement shall inure to the benefit of, and be binding upon, the Company and you, and our respective heirs, legal representatives, successors and assigns.  This Agreement may be assigned by the Company without your consent to any successor entity in the event of a merger, acquisition, change of control, or sale of all or substantially all of the business or assets of the Company.  “Foundation Medicine” and “Company” shall also mean any such successor entity as the context requires.

g. The resolution of any disputes as to the meaning, effect, performance or validity of this Agreement, the Restrictive Covenants Agreement or arising out of, related to, or in any way connected with your employment with the Company or any other relationship between you and the Company will be governed by the law of the Commonwealth of Massachusetts, excluding laws relating to conflicts or choice of law.  Any dispute arising under this Agreement shall be resolved exclusively by arbitration conducted before a single arbitrator in accordance with the Employment Arbitration Rules of JAMS in effect at the time such arbitration is conducted.  All hearings shall be held in Boston, Massachusetts.  Judgment upon the award rendered by the arbitrator may be entered in any court having jurisdiction thereof.  The parties shall bear equally the costs of arbitration, including the costs of the arbitrator.

h. If any portion or provision of this Agreement shall to any extent be declared illegal or unenforceable by a court of competent jurisdiction, then the remainder of this Agreement, or the application of such portion or provision in circumstances other than those as to which it is so declared illegal or unenforceable, shall not be affected thereby, and each portion and provision hereof shall be valid and enforceable to the fullest extent permitted by law.

i. This Agreement may be executed in two counterparts, each of which shall be an original and all of which together shall constitute one and the same instrument.


We look forward to you joining the Company. If you have further questions or require additional information, please feel free to contact me.

Sincerely,

FOUNDATION MEDICINE, INC.

 

/s/ Sarah Larson

By:

 

Sarah Larson

Title:

 

Senior Vice President, Human Resources

 

 



Please confirm your acceptance of this offer by signing this letter and emailing the signed letter to Wendy Durkin.

YOU ACKNOWLEDGE THAT YOU HAVE CAREFULLY READ THIS AGREEMENT, INCLUDING EXHIBIT A, AND UNDERSTAND AND AGREE TO ALL OF THE PROVISIONS IN THIS AGREEMENT AND ITS EXHIBITS.  FACIMILE AND PDF SIGNATURES SHALL HAVE THE SAME LEGAL EFFECT AS ORIGINALS.

Accepted and agreed by:

/s/ Melanie Nallicheri

Employee Signature

Melanie Nallicheri

Print Employee’s Name

Date: September 13, 2016

 

 


 

EXHIBIT A

Employee Non-Competition, Non-Solicitation, Confidentiality and Assignment Agreement

(See attached)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

Non-Competition, Non-Solicitation,
Confidentiality and Assignment Agreement

In consideration and as a condition of my employment or continued employment by Foundation Medicine, Inc. (the “Company”), I hereby agree as follows:

 

 

1. Proprietary Information .  I agree that all information, whether or not in writing, whether or not disclosed before or after I was first employed by the Company, concerning the Company’s business, technology, business relationships or financial affairs that the Company has not released to the general public (collectively, “Proprietary Information”), and all tangible embodiments thereof, are and will be the exclusive property of the Company.  By way of illustration, Proprietary Information may include information or material that has not been made generally available to the public, such as: (a)  corporate information, including plans, strategies, methods, policies, resolutions, notes, email correspondence, negotiations  or litigation; (b)  marketing information, including strategies, methods, customer identities or other information about customers, prospect identities or other information about prospects, or market analyses or projections; (c) financial information, including cost and performance data, debt arrangements, equity structure, investors and holdings, purchasing and sales data and price lists; and (d) operational and technological information, including plans, specifications, manuals, forms, templates, software, designs, methods, procedures, formulas, discoveries, inventions, improvements, biological or chemical materials, concepts and ideas; and (e) personnel information, including personnel lists, reporting or organizational structure, resumes, personnel data, compensation structure, performance evaluations and termination arrangements or documents.  Proprietary Information includes, without limitation, (1) information received in confidence by the Company from its customers or suppliers or other third parties, and (2) all biological or chemical materials and other tangible embodiments of the Proprietary Information.

2. Recognition of Company’s Rights .  I will not, at any time, without the Company’s prior written permission, either during or after my employment, disclose or transfer any Proprietary Information to anyone outside of the Company, or use or permit to be used any Proprietary Information for any purpose other than the performance of my duties as an

employee of the Company.  I will cooperate with the Company and use my best efforts to prevent the unauthorized disclosure of all Proprietary Information.  I will deliver to the Company all copies and other tangible embodiments of Proprietary Information in my possession or control upon the earlier of a request by the Company or termination of my employment.

3. Rights of Others .  I understand that the Company is now and may hereafter be subject to non-disclosure or confidentiality agreements with third persons that require the Company to protect or refrain from use of proprietary information.  I agree to be bound by the terms of such agreements in the event I have access to such proprietary information.

4. Commitment to Company; Avoidance of Conflict of Interest .  While an employee of the Company, I will devote my full-time efforts to the Company’s business and I will not engage in any other business activity that conflicts with my duties to the Company.  I will advise the President of the Company or his or her nominee at such time as any activity of either the Company or another business presents me with a conflict of interest or the appearance of a conflict of interest as an employee of the Company.  I will take whatever action is requested of me by the Company to resolve any conflict or appearance of conflict that it finds to exist.

5. Developments.   I hereby assign and transfer and, to the extent any such assignment cannot be made at present, will assign and transfer, to the Company and its successors and assigns, all my right, title and interest in and to all Developments (as defined below) that:  (a) are created, developed, made, conceived or reduced to practice by me (alone or jointly with others) or under my direction (collectively, “conceived”) during the period of my employment and six (6) months thereafter and that relate to the business of the Company or to products, methods or services being researched, developed, manufactured or sold by the Company; or (b) result from tasks assigned to me by the Company; or (c) result from the use of premises, Proprietary Information or personal property (whether tangible or intangible) owned, licensed or leased by the Company (collectively, “Company-

 


Related Developments”), and all patent rights, trademarks, copyrights and other intellectual property rights in all countries and territories worldwide claiming, covering or otherwise arising from or pertaining to Company-Related Developments (collectively, “Intellectual Property Rights”).  I further agree that “Company-Related Developments” include, without limitation, all Developments that (i) were conceived by me before my employment, (ii) relate to the business of the Company or to products, methods or services being researched, developed, manufactured or sold by the Company, and (iii) were not subject to an obligation to assign to another entity when conceived.  I will make full and prompt disclosure to the Company of all Company-Related Developments, as well as all other Developments conceived by me during the period of my employment and six (6) months thereafter.  I acknowledge that all work performed by me as an employee of the Company is on a “work for hire” basis.  I hereby waive all claims to any moral rights or other special rights that I may have or accrue in any Company-Related Developments.

“Developments” mean inventions, discoveries, designs, developments, methods, modifications, improvements, processes, biological or chemical materials, algorithms, databases, computer programs, formulae, techniques, trade secrets, graphics or images, audio or visual works, and other works of authorship.

If, in the course of my employment with the Company, I incorporate a Development conceived by me before my employment that are not Company-Related Developments (“Prior Inventions”) into a Company product, process or research or development program or other work done for the Company, I hereby grant to the Company a nonexclusive, royalty-free, fully paid-up, irrevocable, perpetual, worldwide license (with the full right to sublicense through multiple tiers) to make, have made, modify, use, offer for sale, import and sell such Prior Invention.  Notwithstanding the foregoing, I will not incorporate, or permit to be incorporated, Prior Inventions in any Company-Related Development without the Company’s prior written consent.

I understand that to the extent this Agreement is required to be construed in accordance with the laws of any state which precludes a requirement in an employee agreement to assign certain classes of inventions made by an employee, this Section will be interpreted not to apply to any invention which a court rules and/or the Company agrees falls within such classes.

6. Documents and Other Materials .  I will keep and maintain adequate and current records of all Proprietary Information and Company-Related Developments conceived by me, which records will be

available to and remain the sole property of the Company at all times.  All files, letters, notes, memoranda, reports, records, data, sketches, drawings, notebooks, layouts, charts, quotations and proposals, specification sheets, program listings, blueprints, models, prototypes, materials or other written, photographic or other tangible material containing or embodying Proprietary Information, whether created by me or others, which come into my custody or possession, are the exclusive property of the Company to be used by me only in the performance of my duties for the Company.  In the event of the termination of my employment for any reason, I will deliver to the Company all of the foregoing, and all other materials of any nature pertaining to the Proprietary Information of the Company and to my work, and will not take or keep in my possession any of the foregoing or any copies.  Any property situated on the Company’s premises and owned by the Company, including laboratory space, computers, disks and other storage media, filing cabinets or other work areas, is subject to inspection by the Company at any time with or without notice.

7. Enforcement of Intellectual Property Rights .  I will cooperate fully with the Company, both during and after my employment with the Company, with respect to the procurement, maintenance and enforcement of Intellectual Property Rights, as well as all other patent rights, trademarks, copyrights and other intellectual property rights in all countries and territories worldwide owned by or licensed to the Company.  I will sign, both during and after the term of this Agreement, all papers, including copyright applications, patent applications, declarations, oaths, assignments of priority rights, and powers of attorney, which the Company may deem necessary or desirable in order to protect its rights and interests in any Company-Related Development or Intellectual Property Rights.  If the Company is unable, after reasonable effort, to secure my signature on any such papers, I hereby irrevocably designate and appoint each officer of the Company as my agent and attorney-in-fact to execute any such papers on my behalf, and to take any and all actions as the Company may deem necessary or desirable in order to protect its rights and interests in the same.

8. Non-Competition and Non-Solicitation . In order to protect the Company’s Proprietary Information and good will, during my employment and for a period of one (1) year following the termination of my employment for any reason (the “Restricted Period”), I will not directly or indirectly, whether as owner, partner, shareholder, director, consultant, agent, employee, co-venturer or otherwise, engage, participate or invest in any business activity anywhere in the world that develops, manufactures or markets any products, or performs any services, that are otherwise competitive with or similar to the

 


products or services of the Company, or products or services that the Company has under development or that are the subject of active planning at any time during my employment; provided that this will not prohibit any possible investment in publicly traded stock of a company representing less than one percent of the stock of such company.  In addition, during the Restricted Period, I will not, directly or indirectly, in any manner, other than for the benefit of the Company, (a) call upon, solicit, divert or take away any of the customers, business or prospective customers of the Company or any of its suppliers, and/or (b) solicit, entice or attempt to persuade any other employee or consultant of the Company to leave the services of the Company for any reason.  I acknowledge and agree that if I violate any of the provisions of this Section, the running of the Restricted Period will be extended by the time during which I engage in such violation(s).

9. Government Contracts .  I acknowledge that the Company may have from time to time agreements with other persons or with the United States Government or its agencies that impose obligations or restrictions on the Company regarding inventions made during the course of work under such agreements or regarding the confidential nature of such work.  I agree to comply with any such obligations or restrictions upon the direction of the Company.  In addition to the rights assigned under Section 5, I also assign to the Company (or any of its nominees) all rights which I have or acquired in any Developments, full title to which is required to be in the United States under any contract between the Company and the United States or any of its agencies.

10. Prior Agreements .  I hereby represent that, except as I have fully disclosed previously in writing to the Company, I am not bound by the terms of any agreement with any previous employer or other party to refrain from using or disclosing any trade secret or confidential or proprietary information in the course of my employment with the Company or to refrain from competing, directly or indirectly, with the business of such previous employer or any other party.  I further represent that my performance of all the terms of this Agreement as an employee of the Company does not and will not breach any agreement to keep in confidence proprietary information, knowledge or data acquired by me in confidence or in trust prior to my employment with the Company.  I will not disclose to the Company or induce the Company to use any confidential or proprietary information or material belonging to any previous employer or others.

11. Remedies Upon Breach .  I understand that the restrictions contained in this Agreement are necessary for the protection of the business and goodwill of the Company and I consider them to be reasonable for such purpose.   Any breach of this

Agreement is likely to cause the Company substantial and irrevocable damage and therefore, in the event of such breach, the Company, in addition to such other remedies that may be available, will be entitled to specific performance and other injunctive relief.

12. Publications and Public Statements .  I will obtain the Company’s written approval before publishing or submitting for publication any material that relates to my work at the Company and/or incorporates any Proprietary Information.  To ensure that the Company delivers a consistent message about its products, services and operations to the public, and further in recognition that even positive statements may have a detrimental effect on the Company in certain securities transactions and other contexts, any statement about the Company which I create, publish or post during my period of employment and for six (6) months thereafter, on any media accessible by the public, including but not limited to electronic bulletin boards and Internet-based chat rooms, must first be reviewed and approved by an officer of the Company before it is released in the public domain.

13. No Employment Obligation .  I understand that this Agreement does not create an obligation on the Company or any other person to continue my employment.  I acknowledge that, unless otherwise agreed in a formal written employment agreement signed on behalf of the Company by an authorized officer, my employment with the Company is at will and therefore may be terminated by the Company or me at any time and for any reason.

14. Survival and Assignment by the Company .  I understand that my obligations under this Agreement will continue in accordance with its express terms regardless of any changes in my title, position, duties, salary, compensation or benefits or other terms and conditions of employment.  I further understand that my obligations under this Agreement will continue following the termination of my employment regardless of the manner of such termination and will be binding upon my heirs, executors and administrators.  The Company will have the right to assign this Agreement to its affiliates, successors and assigns.  I expressly consent to be bound by the provisions of this Agreement for the benefit of the Company or any parent, subsidiary or affiliate to whose employ I may be transferred without the necessity that this Agreement be resigned at the time of such transfer.

15. Disclosure to Future Employers .  I will provide a copy of this Agreement to any prospective employer, partner or co-venturer prior to entering into an employment, partnership or other business relationship with such person or entity.

16. Exit Interview .  If and when I depart from the Company, I may be required to attend an exit

 


interview and sign an “Employee Exit Acknowledgement” to reaffirm my acceptance and acknowledgement of the obligations set forth in this Agreement.  During the Restricted Period following termination of my employment, I will notify the Company of any change in my address and of each subsequent employment or business activity, including the name and address of my employer or other post-Company employment plans and the nature of my activities.

17. Severability .  In case any provisions (or portions thereof) contained in this Agreement will, for any reason, be held invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability will not affect the other provisions of this Agreement, and this Agreement will be construed as if such invalid, illegal or unenforceable provision had never been contained herein.  If, moreover, any one or more of the provisions contained in this Agreement will for any reason be held to be excessively broad as to duration, geographical scope, activity or subject, it will be construed by limiting and reducing it, so as to be enforceable to the extent compatible with the applicable law as it will then appear.

18. Entire Agreement .  This Agreement constitutes the entire and only agreement between the Company and me respecting the subject matter hereof, and supersedes all prior agreements and understandings, oral or written, between us concerning such subject matter.  No modification, amendment, waiver or termination of this Agreement or of any provision hereof will be binding unless made in writing and signed by an authorized officer of the

Company.  Failure of the Company to insist upon strict compliance with any of the terms, covenants or conditions hereof will not be deemed a waiver of such terms, covenants or conditions.  In the event of any inconsistency between this Agreement and any other contract between the Company and me, the provisions of this Agreement will prevail.

19. Interpretation .  This Agreement will be deemed to be made and entered into in the Commonwealth of Massachusetts, and will in all respects be interpreted, enforced and governed under the laws of the Commonwealth of Massachusetts.  I hereby agree to consent to personal jurisdiction of the state and federal courts situated within Suffolk County, Massachusetts for purposes of enforcing this Agreement, and waive any objection that I might have to personal jurisdiction or venue in those courts.  As used in this Agreement, “including” means “including but not limited to.”

BY SIGNING BELOW, I CERTIFY THAT I HAVE READ THIS AGREEMENT CAREFULLY AND AM SATISFIED THAT I UNDERSTAND IT COMPLETELY.

IN WITNESS WHEREOF , the undersigned has executed this agreement as a sealed instrument as of the date set forth below.

Signed:

/s/ Melanie Nallicheri
(Employee’s full name)

Type or print name:   Melanie Nallicheri

Date:   September 13, 2016

 

 

 


 

EXHIBIT A

TO:

Foundation Medicine, Inc.

FROM:

 

DATE:

 

SUBJECT:

Prior Inventions

 

 

The following is a complete list of all inventions or improvements
relevant to the subject matter of my employment by the Company that have been made or conceived or first reduced to practice by me alone or jointly with others prior to my engagement by the Company:

 

No inventions or improvements

 

See below:

 

 

Additional sheets attached

The following is a list of all patents, patent applications and other patent rights that I have invented:

 

None

 

See below:

 

 

 

 

 

Exhibit 31.1

CERTIFICATIONS

I, Troy Cox, certify that:

1.

I have reviewed this Quarterly Report on Form 10-Q of Foundation Medicine, Inc.;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a)

designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)

designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)

evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)

disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a)

all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b)

any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 2, 2018

 

/s/ Troy Cox

Troy Cox

President and Chief Executive Officer

(Principal Executive Officer)

 

 

 

 

Exhibit 31.2

CERTIFICATIONS

I, Jason Ryan, certify that:

1.

I have reviewed this Quarterly Report on Form 10-Q of Foundation Medicine, Inc.;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a)

designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)

designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)

evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)

disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a)

all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b)

any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 2, 2018

 

/s/ Jason Ryan

 

Jason Ryan

Chief Financial Officer

(Principal Financial Officer)

 

 

 

Exhibit 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Each of the undersigned officers of Foundation Medicine, Inc. (the “Company”) hereby certifies to his knowledge that the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2018 (the “Report”), as filed with the Securities and Exchange Commission on the date hereof, fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended, and that the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: May 2, 2018

 

/s/ Troy Cox

Troy Cox

President and Chief Executive Officer

(Principal Executive Officer)

Date: May 2, 2018

 

/s/ Jason Ryan

Jason Ryan

Chief Financial Officer

(Principal Financial Officer)